-----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, FWU2LyB7fG3dpG8tZQWCUY25w66hGuCVIaQhJZZ+tlsBcR5ye930RZCq+pCHBVNC tYl3NWJnt3Y0naue0/pdmg== 0000950137-02-001816.txt : 20020415 0000950137-02-001816.hdr.sgml : 20020415 ACCESSION NUMBER: 0000950137-02-001816 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20011231 FILED AS OF DATE: 20020329 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHEFFIELD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000894158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133808303 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: 1934 Act SEC FILE NUMBER: 001-12584 FILM NUMBER: 02593780 BUSINESS ADDRESS: STREET 1: 425 WOODSMILL RD CITY: ST LOUIS STATE: MO ZIP: 63017 BUSINESS PHONE: 3145799899 MAIL ADDRESS: STREET 1: 425 WOODSMILL RD CITY: ST LOUIS STATE: MO ZIP: 63017 FORMER COMPANY: FORMER CONFORMED NAME: SHEFFIELD MEDICAL TECHNOLOGIES INC DATE OF NAME CHANGE: 19940606 10-K405 1 c68433e10-k405.txt ANNUAL REPORT SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2001 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (NO FEE REQUIRED) Commission file number 1-12584 SHEFFIELD PHARMACEUTICALS, INC. (Exact name of registrant as specified in its Charter) DELAWARE 13-3808303 (State of Incorporation) (IRS Employee Identification Number) 14528 SOUTH OUTER FORTY ROAD STE 205 63017 (314) 579-9899 ST. LOUIS, MISSOURI (Zip Code) (Registrant's telephone, (Address of principal executive offices) including area code) SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: Title of Class Name of each exchange on which registered Common Stock. $.01 par value American Stock Exchange SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: None Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act 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. [X]Yes [ ] No Indicate by check mark if disclosure of delinquent filers to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of the 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. [X] The aggregate market value at March 25, 2002 of the voting stock of the registrant held by non-affiliates (based upon the closing price of $2.27 per share of such stock on the American Stock Exchange on such date) was approximately $48,072,000. Solely for the purposes of this calculation, shares held by the registrant's directors and executive officers and beneficial owners of 10% or more of the Company's Common Stock of the registrant have been excluded. Such exclusion should not be deemed a determination or an admission by the registrant that such persons are, in fact, affiliates of the registrant. Indicate the number of shares outstanding of each of the registrant's classes of common equity, as of the latest practicable date: At March 25, 2002, there were outstanding 29,068,712 shares of the registrant's Common Stock, $.01 par value. DOCUMENTS INCORPORATED BY REFERENCE Certain portions of the Registrant's definitive proxy statement to be filed not later than April 30, 2002 pursuant to Regulation 14A are incorporated by reference in Items 10 through 13 of Part III of this Annual Report on Form 10-K. -1- PART I The following contains certain 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, which are intended to be covered by the safe harbors created thereby. All forward-looking statements involve risks and uncertainty. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore, the Company's actual results may differ materially from the results anticipated in the forward-looking statements. See "Business - Certain Risk Factors that May Affect Future Results, Financial Condition and Market Price of Securities" included herein for a discussion of factors that could contribute to such material differences. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved. ITEM 1. BUSINESS THE COMPANY Sheffield Pharmaceuticals, Inc. (formerly Sheffield Medical Technologies Inc.) ("Sheffield" or the "Company") was incorporated under Canadian law in October 1986. In May 1992, the Company became domesticated as a Wyoming Corporation pursuant to a "continuance" procedure under Wyoming law. In January 1995, the Company's shareholders approved the proposal to reincorporate the Company in Delaware, which was effected on June 13, 1995. The Company provides innovative, cost-effective pharmaceutical therapies by combining state-of-the-art pulmonary drug delivery technologies with existing and emerging therapeutic agents. The Company is developing a range of products to treat respiratory and systemic diseases in its proprietary pulmonary delivery systems, including the Premaire(R) Delivery System ("Premaire") and Tempo(TM) Inhaler ("Tempo"). The Company is in the development stage and, as such, has been principally engaged in the development of its pulmonary delivery systems. Sheffield believes these pulmonary delivery technologies will allow the Company to capitalize on the growing drug delivery market by providing both advanced respiratory treatments and patient-friendly alternatives for therapies that can currently be administered only by injection or other inconvenient means. In 1997, the Company acquired the Premaire, a portable nebulizer-based pulmonary delivery system, through a worldwide exclusive license and supply arrangement with Siemens AG ("Siemens"). During the second half of 1998, the Company acquired the rights to a new generation propellant-based pulmonary delivery system, Tempo, from a subsidiary of Aeroquip-Vickers, Inc. ("Aeroquip-Vickers"). Additionally, during 1998, Sheffield licensed from Elan Corporation, plc ("Elan") the Ultrasonic Pulmonary Drug Absorption System ("UPDAS"), a novel disposable unit dose nebulizer system, and Elan's Absorption Enhancing Technology ("Enhancing Technology"), a therapeutic agent to increase the systemic absorption of drugs. In October 1999, the Company licensed Elan's Nanocrystal(TM) technology to be used in developing certain inhaled steroid products. BUSINESS STRATEGY The Company's business strategy is to seek out opportunities to acquire and develop commercially attractive pharmaceutical products, primarily in the area of pulmonary drug delivery. The Company recognizes that no single technology in the area of pulmonary drug delivery will meet the needs of patients and providers of the wide variety of compounds (both for respiratory disease and systemic disease therapy) that may benefit therapeutically and commercially from pulmonary delivery. As a result, it remains the Company's goal to acquire or in-license a portfolio of pulmonary delivery technologies to meet the broadest based market opportunity. The Company intends to selectively enter into joint ventures or other forms of strategic alliances to access technology and compounds as well as defray or reduce significant development and manufacturing costs associated with these opportunities that otherwise might be borne by the Company. The Company will also retain certain commercial rights to these products. The Company will continue to be opportunistic in the acquisition and/or in-licensing of technologies or products that meet the Company's strategic objectives. Such opportunities include: (1) technologies or products that meet the needs of healthcare providers and patients that are not currently served, (2) technologies or products that can effectively be developed when viewed in light of the commercial opportunity and competitive environment within the U.S. market, (3) technologies or products that will be of substantive interest to other companies with regard to co-development and co-marketing with limited incremental investment by the Company, and (4) products and technologies with the potential for marketing to a specialty group or limited physician audience. The Company plans to pay special attention to platform technologies that can be developed into multiple applications in varying therapeutic categories. STRATEGIC ALLIANCES The Company believes a less costly, more predictable path to commercial development of therapeutics can be achieved through the creative use of collaborations and alliances, combined with state-of-the-art technology and experienced management. The Company is applying this strategy to the development of both respiratory and systemic pharmaceutical products to be delivered through the Company's proprietary pulmonary delivery systems. Using these pulmonary delivery systems as platforms, the Company has established strategic alliances for developing its initial products. -2- The Company is developing a range of pharmaceutical products delivered by the Premaire to treat respiratory diseases. Products initially developed for respiratory disease therapy delivered through the Premaire include albuterol sulfate, ipratropium bromide, sodium cromoglycate and inhaled steroids. In June 1998, the Company sublicensed to Zambon Group SpA ("Zambon") worldwide marketing and development rights to respiratory products to be delivered by the Premaire in return for an equity investment in the Company (approximately 10%). From June 1998 to September 2001, Zambon funded the costs for the respiratory compounds being developed for delivery in the Premaire. In September 2001, the Company amended its 1998 agreement with Zambon whereby Sheffield regained the rights to the Premaire previously granted to Zambon. As part of the amended agreement, Zambon provided a low-interest, $2.5 million loan to Sheffield to progress the development of the Premaire respiratory program. Upon commercialization, Zambon will be entitled to certain royalties on payments received by Sheffield for albuterol sulfate, ipratropium bromide and sodium cromoglycate sales for specified periods. As part of a strategic alliance with Elan, a world leader in pharmaceutical delivery technology, the Company is developing therapies for systemic diseases to be delivered to the lungs using both the Premaire and Tempo. In 1998, the systemic applications of the Premaire and Tempo were licensed to Systemic Pulmonary Delivery, Ltd. ("SPD"), a wholly owned subsidiary of the Company. In addition, two Elan technologies, UPDAS and the Enhancing Technology, have also been licensed to SPD. The Company has retained exclusive rights outside of the strategic alliance to respiratory disease applications utilizing the Tempo technology and the two Elan technologies. In addition to the above alliance with Elan, in 1999, the Company and Elan formed a joint venture, Respiratory Steroid Delivery, Ltd. ("RSD"), a 80.1% owned subsidiary of the Company and 19.9% owned by Elan, to develop certain inhaled steroid products to treat certain respiratory diseases using Elan's NanoCrystal(TM) dispersion technology. The inhaled steroid products being developed include a unit-dose-packaged steroid dispersion formulation for delivery using a conventional tabletop nebulizer, and a steroid dispersion formulation for delivery using the Premaire system. Outside of these alliances, the Company owns the worldwide rights to respiratory disease applications of all of its technologies. The Company is also currently in discussions with a number of pharmaceutical and biotechnology companies concerning potential collaborations for developing specific compounds (both respiratory and systemic) in the Tempo. Unlike the Premaire, Tempo is a technology that lends itself to individual product applications in the respiratory market. While the Tempo technology may be applicable to a wide range of respiratory products, the Company believes that a full line of products delivered by Tempo is not necessary for commercial success. The reverse is true with the Premaire, since one of the Premaire's primary competitive advantages is the delivery of a range of drugs in interchangeable cartridges used with the parent nebulizer device. PULMONARY DELIVERY MARKET ENVIRONMENT The Company competes in the pulmonary delivery market. The principal use of pulmonary delivery has been in the treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease ("COPD") and cystic fibrosis. There is significant advantage in aerosol therapy for respiratory disease. Pulmonary administration delivers the medication directly onto the lung's epithelial surfaces. In many cases, this means that drugs can be effective in very low doses -- reducing the side effects often associated with systemic administration. In 1998, industry sources estimate there were approximately 35.5 million asthma patients and 49.5 million COPD patients worldwide. These sources indicate that the number of newly diagnosed patients is growing at a rate in excess of 10% annually due to an increase in worldwide air pollution levels and the overall aging of the population. By the year 2005, the Company expects that there will be more than 19 million asthma patients in the United States alone. In addition, the competitive marketplace has been significantly affected by the worldwide phase out of clorofluorocarbons ("CFCs") pursuant to the Montreal Protocol. CFCs are the propellants traditionally used in pressurized metered dose inhalers ("pMDIs"), which are the most common form of pulmonary delivery. Companies in the respiratory market have initiated significant programs to redevelop existing products using alternative propellants, dry powders or aqueous-based nebulizers. There is considerable interest in applying pulmonary delivery technology to systemic therapies that would benefit from the relatively easy administration to the circulatory system through the lungs. Work on pulmonary delivery of insulin by other pulmonary delivery companies has received significant public notice. There is a range of therapies that could provide a significant market opportunity if available in an inhaled delivered form. Today, three types of devices are widely used in pulmonary drug administration: pressurized metered dose inhalers, dry powder inhalers, and nebulizers. Pressurized Metered Dose Inhalers. Currently, pMDIs are the most commonly used pulmonary delivery system. It is estimated that in the United States over 80% of pulmonary drug delivery is via pMDI, with the majority of this use coming from adults with asthma and COPD. The main components of a pMDI include a canister containing the drug mixed with propellant and surfactant, a mouthpiece that acts as the delivery conduit and the metering valve for the release of precise quantities of the drug. The initial velocity of particle -3- and propellant droplets as they leave an inhaler is very high -- approximately 2-7 meters per second -- resulting in wasted drug if the patient is not able to coordinate his/her breath with the delivery of aerosol into the mouth. A number of studies have demonstrated that as many as 80% of patients cannot accurately time their inspiration with the actuation of their inhaler which results in under medication and lack of compliance. Typically, less than 20% of metered drug actually reaches the lungs. The primary advantages of a pMDI include its excellent storage and metering capability, small size, portability, fast usage time, and its availability for use with most respiratory drugs. Disadvantages of a pMDI include patient coordination issues and efficient dose delivery. Additionally, because the use of CFCs traditionally used in pMDIs are being phased out by international agreement (Montreal Protocol), alternative propellants and formulations are being developed. Over time, all current pMDI users will be required to move to a non-CFC pMDI or other alternative delivery systems. The majority of U.S. patients favor aerosol pMDIs although a sizable percentage may not coordinate them properly. Dry Powder Inhalers. Dry powder inhalers ("DPIs") were introduced in the 1960s as single-dose inhalers. In these devices, the drug is loaded as a unit dose that is mechanically released as a powder for inhalation prior to each use. To date, these relatively cumbersome systems have been the primary form of DPI available in the United States, and account for approximately 1% of the total aerosol delivery market. The inconvenience of the single dose DPI has been overcome outside of the U.S. with the development and introduction of multi-dose DPIs that can deliver up to 200 doses of medication. However, like the single dose systems, they are inspiratory flow rate dependent; that is, the amount of drug delivered to the lung depends on the patient's ability to inhale. Two of the most significant advantages of DPIs include (1) no hand-breath coordination is required as with pMDIs; and (2) they contain no CFCs. However, most require a high inspiratory flow rate, which can be problematic in younger patients or patients with compromised lung function. In addition, they often present difficulties for those with manual disabilities (e.g., arthritis) or limited vision and, depending upon the powder load delivered, they may induce acute bronchospasm in sensitive individuals. Additionally, multi-dose powder inhalers are subject to moisture sensitivity either from the environment or patient breath and have had difficulty meeting U.S. regulatory standards for dose-to-dose variation. Nebulizers. The third widely used aerosol delivery system is the nebulizer. Jet nebulizers, which are the most commonly used nebulizer, work on a stream of compressed air or oxygen that is forced through a narrow tube lying just above the surface of the liquid to be nebulized. It takes approximately 10 to 15 minutes to nebulize this amount of liquid. Studies suggest keeping the duration of nebulization short, as longer durations are associated with poor compliance. During nebulization only about 10% of the drug is delivered to the lungs; about 80% gets trapped in the reservoir, tubing, mask or the patients mouth and throat; the rest is exhaled. Nebulizers can be used for a wide range of patients, but are especially useful for those older and younger patients who cannot manage other inhaler devices. Nebulizers also play a key role in emergency room and intensive care treatment for patients with acute bronchospasm. Another feature exclusive to nebulizers is that a mixture of drugs can be administered in one sitting. However, currently approved nebulizers are bulky tabletop units that are time consuming, have a high initial cost (often in excess of the amount reimbursable by managed care) and can be noisy during operation. PREMAIRE(R) DELIVERY SYSTEM The Premaire system has been developed to provide the therapeutic benefit of nebulization with the convenience of pressurized pMDIs in one system. The Premaire was developed to meet specific needs within the respiratory market, particularly for pediatric and geriatric patients suffering from asthma and COPD. Description of the Premaire The Premaire is comprised of two main components: (1) a reusable, pocket-size inhaler unit developed and manufactured for the Company by Siemens; and (2) drug cartridges, called Dosators(TM), containing multiple doses of drug formulation assembled and filled by Chesapeake Biological Laboratories. The cartridges are an integral part of the total system. The cartridge plus each drug formulation will be the subject of a separate drug device combination New Drug Application ("NDA"). The basic technology of the system involves the rapid atomization of therapeutic agents using ultrasonic energy. This produces a concentrated soft mist of medication delivered through the mouthpiece over a one to two second period for inhalation. The key components of the technology are housed in the inhaler unit. They are the rechargeable battery-operated motor, ultrasonic horn and drug cartridge. The pocketsize Premaire allows for administration of a range of drugs in a single, simple-to-use, environmentally friendly delivery system. Each cartridge contains, depending on formulation, approximately a one-month supply of the drug. To use the Premaire system, a patient simply selects the appropriate color-coded drug cartridge and places it into the chamber of the inhaler unit. Pressing the "on" button activates a small electrical motor that transports a precise dose of drug from the cartridge chamber to the ultrasonic horn -- transforming the solution into an aerosolized cloud. The patient's inspiratory breath carries this cloud of medication directly to the lungs where it is needed. The dose delivered by the Premaire is very accurate and consistent because: (1) the Premaire is designed to be inspiratory flow rate independent; that is, delivery of the drug does not depend upon the patient's ability to inhale forcefully, and (2) the Premaire does not require a high level of coordination between inspiration and actuation of the device. The patient's natural breath carries the medication directly to the lungs, minimizing the amount of drug deposited in the mouth and throat. -4- Premaire Advantages The Company believes that the Premaire provides significant advantages over other drug delivery systems. It is particularly suited for younger and older asthma patients, as well as for older COPD patients who have difficulty using pMDIs and currently have to depend on larger, more time-consuming tabletop nebulizers for delivery of their medications. These potential advantages include: Accuracy. The superior engineering and patient-friendly design of the Premaire is intended to provide minimal dose-to-dose variability. Patients can therefore expect to receive the right therapeutic dose consistently. Testing of the Premaire delivery system has shown that dose-to-dose variability with the Premaire is significantly better than the current FDA requirement. Enhanced Patient Compliance. The pocketsize, portable Premaire unit is designed to combine the therapeutic benefits of nebulization with the convenience of pressurized metered dose inhalers. The drug dose is precisely measured and delivered in a minute, as compared to 10 to 15 minutes or more for the typical nebulizer. The device is easy to operate, requiring minimal coordination between actuation and inhalation for proper drug delivery. These benefits are expected to improve patient compliance with the proper administration of their respiratory medication. Another expected factor in enhanced patient compliance is the broad range of drugs that can be accommodated by the Premaire, allowing patients on multiple medications to rely on one simple delivery system. Inspiratory Flow Rate Independence. Unlike most of the DPIs currently available (or in development), the Premaire is designed to achieve a consistent and significant level of drug deposition over a broad range of inspiratory flow rates. This is especially important in younger patients or patients with compromised lung function (e.g., during an asthma attack) that have a difficult time breathing normally. Versatility. Many asthma and COPD patients are taking multiple inhalation medications. The Premaire accommodates drug cartridges to allow for the administration of a broad range of frequently used respiratory drugs in a single, simple-to-use delivery system. The system includes an early warning mechanism that signals when the batteries need recharging or when the dosator is not functioning properly and a dose counter indicating when a new inhaler unit is required. These user-friendly features result in a simplified dosing procedure for both patients and their caregivers. Pulmonary Targeting. The particle size of the inhaled medication affects the effectiveness of drug delivery to the lung. Generally, a drug is "respirable" if the particle size is between two and five microns. Larger particles tend to deposit in the inhaler or in the patient's mouth and throat. Smaller particles tend to be exhaled. Within the respirable range, the Premaire is designed to deliver particles specifically targeted for certain portions of the lungs; for example, the central lung for local treatment or the deep lung for enhanced absorption into the blood stream for systemic therapies. Environmentally Friendly. CFCs, the most commonly used propellant for pMDI aerosols, are believed to adversely affect the Earth's ozone layer. They are subject to worldwide regulations aimed at eliminating their production and use within the decade under the Montreal Protocol. The Premaire does not use CFCs or any other type of ozone depleting propellant. Economical. The Company believes that the Premaire offers significant value to the patient because it is designed to allow a single device to be used with a variety of respiratory medications available in cost-effective interchangeable cartridges. The inhaler unit itself is expected to have a life of up to two years. The initial cost of the inhaler unit is expected to be within the cost range that managed care providers will reimburse patients. The Company anticipates the combined cost to the patient of the device plus the drug filled cartridges will be comparable to the average cost per dose of the standard metered dose inhaler. Premaire Product Pipeline in Development The Company is implementing a broad development strategy for the Premaire. The Company is developing a range of widely used respiratory drugs for delivery in the Premaire. Initial drugs being developed for respiratory disease therapy include albuterol sulfate, ipratropium bromide, sodium cromoglycate, and budesonide, an inhaled bronchial steroid, each of which is described below. As previously discussed, in June 1998, the Company sublicensed to Zambon worldwide marketing and development rights to respiratory products to be delivered by the Premaire. From June 1998 to September 2001, Zambon developed and funded the costs for the respiratory compounds being developed for delivery in the Premaire. In September 2001, the Company amended its 1998 agreement with Zambon whereby Sheffield regained the rights to the Premaire previously granted to Zambon. As a result, the sponsorship of the Premaire respiratory development programs was transferred from Zambon to the Company with the Food and Drug Administration ("FDA") being notified accordingly. Sheffield has reviewed all of the development work completed-to-date, identifying a number of deficiencies in the Zambon development program. To address these issues, Sheffield has made a number of internal management changes and moved the program to a group of highly experienced pulmonary clinical and regulatory experts. The Premaire device is currently in a to-be-marketed form and fully industrialized. The following details the status of the respiratory applications being developed in the Premaire system: ALBUTEROL SULFATE. Albuterol sulfate, a beta agonist, is a bronchodilator used as rescue therapy for patients with asthma and COPD. It is the largest selling respiratory compound with U.S. sales of over $500 million in all dosage forms. It is available in a metered dose inhaler and nebulizer solution as well as solid and liquid dosage forms. -5- Status: Zambon initiated a Phase II clinical trial in December 1999 that compared the Premaire-albuterol sulfate to a conventional albuterol-pMDI. Findings from Phase II studies indicated that Premaire-albuterol and pMDI-albuterol were comparable in improving lung function in the 24 adult patients. An end of Phase II meeting was held in February 2002 with the FDA where the results of the development activities-to-date, specifically the results of the Phase II trial, were reviewed. The Company is currently reviewing the FDA's comments and recommendations, integrating the information into the plans for the Phase III trial and NDA submission. The Company expects to begin pivotal clinical trials for the albuterol sulfate program by the end of 2002. BUDESONIDE. Budesonide is a corticosteroid, anti-inflammatory agent that treats the underlying inflammation in the lungs of asthma and COPD patients. It is currently available in a DPI, nebulizer respule and pMDI in Europe. Steroids are the fastest growing category in the respiratory market, growing at 20% per year. Status: Preclinical formulation development work is currently underway. A formulation developed by Nanosystems has proven a feasible candidate for delivery in the Premaire. The formulation is dependent on a proprietary nanocrystaline dispersion of budesonide in an aqueous carrier. Tow other alternative formulation approaches are also under evaluation. Upon scale-up and production of clinical batches released under CMC protocol, an IND will be prepared for filing with the FDA, which is currently planned for the first half of 2003. IPRATROPIUM BROMIDE. Ipratropium bromide is a bronchodilator used primarily to treat COPD patients. It is useful because of its anticholinergic properties, which reduce pulmonary congestion. It is available in a metered dose inhaler, nebulizer solution and a combination product with albuterol. Status: Zambon initiated a Phase I/II clinical trial in Europe in January 2000 assessing the safety and efficacy compared to a commercially available ipratropium bromide product delivered by a pMDI and placebo in patients with COPD. The results of the study indicated that both Premaire-ipratropium bromide and pMDI-ipratropium were tolerated and improved lung function in the COPD patients. An Investigational New Drug Application ("IND") was filed by Zambon with the FDA in May 2000. During 2001, the IND was transferred to the Company. The Company does not intend to further develop this product on its own as the program has progressed to the point where a potential licensing partner would be in a position to take the product into clinical studies. SODIUM CROMOGLYCATE. Sodium cromoglycate is a non-steroidal, anti-inflammatory drug used to reduce the underlying bronchial inflammation associated with asthma. It is extremely safe and it is most commonly used to treat pediatric patients. It is available in a pMDI and nebulizer solution. Status: An IND was filed by Zambon with the FDA in July 2000. No further development work is anticipated to be completed on this product, as the projected market opportunity for sodium cromoglycate is currently deemed too small to justify further progression. OTHER RESPIRATORY THERAPIES. In addition to the drugs listed above, the Company continues to assess the market potential for certain other respiratory therapies. These therapies may include a combination of an anti-inflammatory and beta agonist, an anticholinergic and beta agonist, as well as antibiotics for cystic fibrosis treatments. SYSTEMIC APPLICATIONS: Through its development alliance with Elan, the Company evaluated certain drugs for systemic treatment by pulmonary delivery through Premaire. By identifying a market opportunity for a rapid-acting, non-invasive treatment for breakthrough pain, the first drug to be tested for delivery in Premaire was morphine. The pain management market includes patients with cancer, post-operative, migraine headache and chronic persistent pain. Narcotic analgesics for treatment of these severe forms of pain are estimated to exceed $1.0 billion in worldwide sales in the year 2000. Status: In July 1999, the Company completed a gamma scintigraphy/pharmacokinetic trial comparing morphine delivered using the Premaire to subcutaneous injection. The Premaire demonstrated good pulmonary deposition and very rapid absorption, more rapid peak blood levels vs. subcutaneous injection and low oral and throat deposition. As part of the development alliance with Elan, Elan has the first right of refusal on the development of any product developed by the joint venture. Elan has chosen not to license this product from the joint venture. As such, the joint venture continues to seek to attract a partner for the continued development and commercialization of this product. TEMPO(TM) INHALER Tempo, a new generation pMDI, was developed to correct major deficiencies associated with existing pMDI technology. pMDIs have provided convenient, safe, self-administered treatment for over 30 years and decreased the cost of therapy because the patient at home can use them with minimal medical supervision. However, proper use of current pMDIs requires training and precise execution of the delivery technique. For these reasons, many patients do not use their pMDIs in the prescribed manner to coordinate actuation and inhalation. Incorrect technique has been shown to result in little or no benefits from pMDI use in half of all adult patients and in a greater proportion of children. Moreover, because of these coordination issues, most children under age five cannot use a standard pMDI. Even with correct technique, current pMDIs typically deliver less than 20% of the drug to the lungs of the patient. The remainder of the drug is wasted upon deposition on the back of the mouth, or by completely missing the airway. This results from: (1) the high linear -6- velocity (two to seven meters/second) of the aerosol jet as it discharges; (2) incomplete evaporation of the propellant leading to large size droplets that deposit in the mouth and larynx rather than reaching the lung; and (3) inadequate mixing resulting in a non-uniform distribution of drug particles in the inspiratory flow stream. Drug deposited in the mouth and throat can be swallowed and absorbed systemically or, in the case of inhaled steroids, may create a local concentration of the drug that causes immunosuppression response and the development of fungal infections. In addition, swallowing beta agonist bronchodilators may result in adverse effects on heart rate, blood pressure, glucose and potassium. From a therapeutic view, the most serious problem with pMDIs is inconsistency of delivery. With existing pMDIs the actual dose can vary from 0% to 300% of the intended dose. Patients may not receive sufficient drug to achieve a therapeutic effect, or they may overdose with undesirable side effects. These conditions can lead to the need for emergency treatment. A major advantage for the Tempo technology is that it uses the same aerosol canisters and valves as are currently used in existing pMDIs. As a result, existing aerosol facilities will be able to produce canisters with formulations optimized for use in Tempo. The only additional step required is to place the aerosol canister in the "device" prior to final packaging. This results in a cost effective product and provides numerous benefits to patients. The device along with the canister is disposable when the canister is empty. The Tempo technology features two improvements over existing pMDIs and dry powder inhalers. Fluid dynamics modeling, in-vitro and human trials indicate that up to 60% of drug emitted by the Tempo reaches the lungs with oral deposition reduced to approximately 15%. Because of this increase in efficiency, Tempo should require less drug per actuation than existing devices to achieve the same therapeutic effect. This may result in more unit doses per drug canister than a conventional pMDI, with less potential for adverse reactions. Tempo also features a unique proprietary triggering mechanism that actuates at the correct time during inhalation. It is designed to automatically adjust to the patient's breathing pattern to accommodate differences in age and disease state. This synchronous trigger is designed to reduce patient coordination problems and enhance patient compliance. Description of the Tempo The Tempo technology utilizes a standard aerosol pMDI canister and metering valve, encased in a compact device that provides an aerosol flow-control chamber and a synchronized triggering mechanism. Manipulation of the discharged drug- containing aerosol cloud is key to optimization of the efficiency and consistency for pMDIs. The Tempo design uses fluid dynamics to: (1) reduce the velocity of the drug relative to the inspiratory breath velocity (less than one meter/second); (2) increase residence time of the aerosol droplets before exiting the device to allow near complete evaporation of the propellant; (3) increase droplet dispersion and mixing, thus increasing evaporation and improving vapor fraction at every point along the flow path; (4) reduce the diameter of the drug particles at the exit plane of the device; (5) decrease inertia of droplets to reduce impaction; and (6) improve timing of dose discharge with inspiratory breath for increased drug deposition in lungs. The unique features of Tempo are: Aerosol Flow-Control Chamber. The aerosol flow-control chamber allows the patient to inhale through the device at a normal breathing rate, instead of a forced breath. The inspiratory breath establishes flow fields within the device that mix and uniformly disperse the drug in the breath. In the mouthpiece, nearly all the propellant is evaporated leaving only drug particles to be inspired, allowing a significant increase in the amount of drug delivered to the lungs. Only small amounts of drug deposit in the mouth and throat. Synchronizing Trigger Mechanism. A triggering and timing mechanism that is synchronized with the patient's inspiratory breath controls the discharge of the metering valve. Tempo can accommodate different inspiratory flow rates, so any patient can activate the triggering device. Similarly, the timing mechanism will automatically adjust to the flow generated by the patient, delaying or hastening discharge in proportion to the total volume passing through the flow control chamber. This feature accommodates differences in inspiratory flow characteristic of pulmonary disease states in children, adults and the infirm. Tempo Advantages The Company believes that the Tempo technology possesses many potential competitive advantages over other inhalation systems in both local respiratory and systemic applications. It is applicable to all age categories, eliminating the most troublesome problems of aerosol metered dose delivery. Increased efficiency allows for potential application to proteins and peptides formerly not considered as candidates for aerosol delivery. The performance characteristics of the Tempo are expected to translate into multiple benefits, including: Improved Drug Delivery Efficiency. A higher percentage of the drug emitted by the Tempo is delivered to the lungs than current inhalation systems while approximately 15% is lost through deposition in the mouth and throat. The improved delivery efficiency enhances efficacy, reduces side effects and provides greater consistency of dose administration. Greater Patient Compliance. The Tempo reduces technique dependence for simple, consistent dose-to-dose delivery, resulting in improved compliance with prescribed therapy. -7- Broader Patient Base. The Tempo can be prescribed for a broader patient base since it is designed to be self-administered by children and the elderly as well as adult patients. Pharmacoeconomic Benefit. The Tempo has increased delivery efficiency with less waste, so patients can receive more unit doses per standard canister. This allows for a lower drug cost per day in addition to reducing prescription and payer costs because fewer pharmacy visits are required. Tempo Product Pipeline in Development TEMPO SYSTEMIC THERAPIES. The development of systemic drugs using Tempo is being conducted as part of the Company's alliance with Elan. The initial product developed was targeted to address migraine headaches. The Company utilized ergotamine tartrate as a proof-of-principle product. Ergotamine, an alpha adrenergic blocking agent, is a therapy to stop or prevent vascular headaches such as migraines. Migraine headaches affect up to 30 million Americans. Worldwide annual drug sales for the migraine therapy market are in excess of $2.4 billion with many patients unable to get satisfactory relief from currently available therapies. In fact, it is estimated that absenteeism and medical expenses resulting from migraine total $50 billion annually. Current oral drug therapies for the treatment of migraine headaches have slow onset of action, resulting in a medical need that may be better satisfied through pulmonary delivery. Status: In December 1999, the Company completed a gamma scintigraphy/pharmacokinetic trial comparing the Tempo to a conventional pMDI. The trial showed successful delivery of the drug to all regions of lung with significantly reduced mouth and throat deposition, and rapid drug absorption. As part of the development alliance with Elan, Elan has the first right of refusal on the development of any product developed by the joint venture. Elan has chosen not to license this product from the joint venture. As such, the joint venture continues to seek to attract a partner for the continued development and commercialization of this product. As a result of the work performed on the ergotamine product noted above, Sheffield initiated a new development program for a novel formulation of dyhydroergotamine ("DHE") for pulmonary delivery in the Tempo for the treatment of specific types of migraines. Formulation work for this program is currently underway. The Company is also currently in discussions with a pharmaceutical company for the development and manufacturing of this product. TEMPO RESPIRATORY THERAPIES. The Tempo has broad applicability across respiratory disease therapies since it utilizes basic pMDI delivery methods that are the most popular forms of respiratory delivery. The Tempo technology's ability to significantly minimize oral deposition makes it especially applicable to steroids and steroid combinations with which fungal overgrowth side effects are common. In addition, U.S. patients and physicians have indicated that they prefer metered dose aerosol delivery. The Tempo technology is positioned to take advantage of this built-in market preference for pMDIs with its potential for superior performance, reduced adverse reactions and cost-effectiveness. Inhaled steroids are the fastest growing segment of the respiratory market and the largest in Europe. The features of the Tempo directly minimize the aspects of inhaled steroids that remain a concern to patients and physicians. The market for inhaled steroids on a worldwide basis is approximately $2.0 billion. Status: In September 2000, the Company completed a pilot study using the Tempo to deliver a patented respiratory drug used to treat asthma. The study measured the distribution of this respiratory drug delivered by Tempo compared to the distribution of this same drug delivered through a commercially available pMDI in 12 healthy volunteers. Results of this study demonstrated that Tempo significantly increased drug deposition in all regions of the lung. Tempo delivered approximately 200% more drug to the lungs, deposited approximately 75% less drug in the mouth, and increased dosing consistency by approximately 55% compared to the currently marketed form of this same drug. The Company is using the results of this study as a basis for conducting discussions for feasibility work and/or clinical studies with potential collaboration partners. As with Premaire, there remain opportunities for developing Tempo for a range of therapies either directly by the Company or in collaboration with strategic partners. Unlike the Premaire, it is potentially advantageous for the Company to partner on a product-by-product basis, concentrating on prime partners to launch the system commercially and to aid in subsequent development with products developed specifically for exclusive commercialization by the Company. INHALED STEROID PRODUCTS In October 1999, the Company and Elan formed a separate joint venture to develop certain inhaled steroid products to treat certain respiratory diseases that will utilize Elan's Nanocrystal(TM) dispersion technology and Sheffield's pulmonary delivery systems. Because of the difficulties in formulating steroids for delivery through a solution-based inhalation system, only one steroid product is currently available in the United States for delivery through a nebulizer. The estimated worldwide market for inhaled steroids is $2 billion annually and growing at 20% per year. The products being formulated using Elan's Nanocrystal technology and the status of each are as follows: Unit-dose nebulizer program - This product is for inhalation delivery in a standard commercial tabletop device using the steroid budesonide, formulated using the NanoCrystal technology. A Phase I, double-blind safety and pharmacokinetic study of nebulized nanobudesonide in 16 healthy volunteers was satisfactorily completed at Thomas Jefferson University Hospital in February 2002. This study compared single doses of Pulmicort Respules, nanobudesonide and placebo. Data from the study is currently undergoing final data and statistical analysis. Premaire nanobudesonide program - This product is for inhalation delivery using the Company's Premaire device. The joint venture is currently conducting formulation work on this product. See "Premaire Delivery System" above for further discussion of this product. -8- OTHER TECHNOLOGIES AND PROJECTS Ultrasonic Pulmonary Drug Absorption System The UPDAS(TM) is a novel ultrasonic pulmonary delivery system designed by Elan as a disposable unit dose nebulizer system. UPDAS was designed primarily for the delivery of proteins, peptides and other large molecules to the lungs for absorption into the bloodstream. Elan's preliminary research with UPDAS demonstrated unique atomization that may prevent denaturing of bioactive molecules and particle size distribution that meets the targets for local and systemic delivery. The Company is not conducting any development work related to this technology. Absorption Enhancing Technology As part of the same transaction in which the Company acquired UPDAS, the Company also acquired a worldwide exclusive license to Elan's Absorption Enhancing Technology. While not a delivery system itself, the Enhancing Technology is a therapeutic agent identified by Elan to increase the systemic absorption of drugs delivered to the lungs. The Enhancing Technology may be utilized in conjunction with the Company's other pulmonary delivery systems. The Company is not conducting any development work related to this technology. Early Stage Research Projects As part of the Company's focus on later stage pharmaceutical opportunities, the Company is seeking to out-license its portfolio of early stage medical research projects to companies that are committed to early stage biotechnology opportunities. The Company has determined that its early stage technologies do not fit the Company's pulmonary drug delivery strategy. Consequently, the Company plans to out-license these technologies while maintaining an interest in the technologies' promise without incurring the development costs associated with early stage research and development. Because the Company is no longer funding these projects, it is at risk of losing its rights to certain of these technologies. There can be no assurance that the Company will be able to sell or license its rights to any of its remaining early stage research projects or realize any milestone payments or other revenue from those early stage research projects that have been previously divested. In November 1997, the Company entered into a license arrangement for some of its early stage technologies with Lorus Therapeutics, Inc. (formerly Imutec Pharma Inc.). The arrangement licenses rights to a series of compounds for the treatment of cancer, Kaposi's sarcoma and actinic keratosis to a newly formed company, NuChem Pharmaceuticals, Inc. ("NuChem") for which Lorus Therapeutics will provide funding and management of the development program. The Company holds a 20% equity interest in NuChem. Work on the lead compounds by NuChem has progressed in the pre-clinical phase. In 1999, NuChem announced that the U.S. National Cancer Institute has agreed to undertake additional in vitro screening after initial evaluation of the compounds. In 2000, NuChem chose NC 381 as its lead anti-cancer drug for further studies in preparation for clinical trials. Preclinical toxicology studies are currently underway. GOVERNMENT REGULATION The Company's research and development activities and, ultimately, any production and marketing of its licensed products, are subject to comprehensive regulation by numerous governmental authorities in the United States and other countries. Among the applicable regulations in the United States, pharmaceutical products are subject to the Federal Food, Drug & Cosmetic Act, the Public Health Services Act, other federal statutes and regulations, and certain state and local regulations. These regulations and statutes govern the development, testing, formulation, manufacture, labeling, storage, record keeping, quality control, advertising, promotion, sale, distribution and approval of such pharmaceutical products. Failure to comply with applicable requirements can result in fines, recall or seizure of products, total or partial suspension of production, refusal by the government to approve marketing of the product and criminal prosecution. A new drug may not be legally marketed for commercial use in the United States without FDA approval. In addition, upon approval, a drug may only be marketed for the indications, in the formulations and at the dosage levels approved by the FDA. The FDA also has the authority to withdraw approval of drugs in accordance with applicable laws and regulations. Analogous foreign regulators impose similar approval requirements relating to commercial marketing of a drug in their respective countries and may impose similar restrictions and limitations after approval. In order to obtain FDA approval of a new product, the Company and its strategic partners must submit proof of safety, efficacy, purity and stability, and the Company must demonstrate validation of its manufacturing process. The testing and application process is expensive and time consuming, often taking several years to complete. There is no assurance that the FDA will act favorably or quickly in reviewing such applications. With respect to patented products, processes or technologies, delays imposed or caused by the governmental approval process may materially reduce the period during which the Company will have the exclusive right to exploit them. Such delays could also affect the commercial advantages derived from proprietary processes. As part of the approval process, the FDA reviews the Drug Master File (the "DMF") for a description of product chemistry and characteristics, detailed operational procedures for product production, quality control, process and methods validation, and quality assurance. As process development continues to mature, updates and modifications of the DMF are submitted. The FDA approval process for a pharmaceutical product includes review of (i) chemistry and formulations, (ii) preclinical laboratory and animal studies, (iii) initial IND clinical studies to define safety and dose parameters, (iv) well-controlled IND clinical trials to demonstrate product efficacy and safety, followed by submission and FDA approval of a New Drug Application (the "NDA"). Preclinical studies involve -9- laboratory evaluation of the product and animal studies to assess activity and safety of the product. Products must be formulated in accordance with United States Good Manufacturing Procedures ("GMP") requirements and preclinical tests must be conducted by laboratories that comply with FDA regulations governing the testing of drugs in animals. The results of the preclinical tests are submitted to the FDA as part of the IND application and are reviewed by the FDA prior to granting the sponsor permission to conduct clinical studies in human subjects. Unless the FDA objects to an IND application, the application will become effective 30 days following its receipt by the FDA. There can be no certainty that submission of an IND will result in FDA authorization to commence clinical studies. Human clinical trials are typically conducted in three sequential phases with some amount of overlap allowed. Phase I trials normally consist of testing the product in a small number of normal volunteers for establishing safety and pharmacokinetics using single and multiple dosing regiments. In Phase II, the continued safety and initial efficacy of the product are evaluated in a limited patient population, and appropriate dosage amounts and treatment intervals are determined. Phase III trials typically involve more definitive testing of the appropriate dose for safety and clinical efficacy in an expanded patient population at multiple clinical testing centers. A clinical plan, or "protocol," accompanied by the approval of the institution participating in the trials, must be submitted to the FDA prior to commencement of each clinical trial phase. Each clinical study must be conducted under the auspices of an Institutional Review Board (the "IRB") at the institution performing the clinical study. The IRB is charged with protecting the safety of patients in trials and may require changes in a protocol, and there can be no assurance that an IRB will permit any given study to be initiated or completed. In addition, the FDA may order the temporary or permanent discontinuation of clinical trials at any time. The Company must rely on independent investigators and institutions to conduct these clinical studies. All the results of the preclinical and clinical studies on a pharmaceutical product are submitted to the FDA in the form of an NDA for approval to commence commercial distribution. The information contained in the DMF is also incorporated into the NDA. Submission of an NDA does not assure FDA approval for marketing. The application review process often requires 12 months to complete. However, the process may take substantially longer if the FDA has questions or concerns about a product or studies regarding the product. In general, the FDA requires two adequate and controlled clinical studies demonstrating efficacy with sufficient levels of statistical assurance. However, additional support may be required. The FDA also may request additional information relating to safety or efficacy, such as long-term toxicity studies. In responding to an NDA, the FDA may grant marketing approval, require additional testing and/or information, or deny the application. Accordingly, there can be no assurance about any specific time frame for approval, if any, of products by the FDA or foreign regulatory agencies. Continued compliance with all FDA requirements and conditions relative to an approved application, including product specifications, manufacturing process, labeling and promotional material, and record keeping and reporting requirements, is necessary throughout the life of the product. In addition, failure to comply with FDA requirements, the occurrence of unanticipated adverse effects during commercial marketing or the result of future studies, could lead to the need for product recall or other FDA-initiated actions that could delay further marketing until the products or processes are brought into compliance. The facilities of each pharmaceutical manufacturer must be registered with and approved by the FDA as compliant with GMP. Continued registration requires compliance with standards for GMP. In complying with GMP, manufacturers must continue to expend time, money and effort in production, record keeping and quality control to ensure technical compliance. In addition, manufacturers must comply with the United States Department of Health and Human Services and similar state and local regulatory authorities if they handle controlled substances, and they must be registered with the United States Drug Enforcement Administration and similar state and local regulatory authorities if they generate toxic or dangerous waste streams. Other regulatory agencies such as the Occupational Safety and Health Administration also monitor a manufacturing facility for compliance. Each of these organizations conducts periodic establishment inspections to confirm continued compliance with its regulations. Failure to comply with any of these regulations could mean fines, interruption of production and even criminal prosecution. For foreign markets, a pharmaceutical company is subject to regulatory requirements, review procedures and product approvals, which, generally, may be as extensive, if not more extensive, as those in the United States. Although the technical descriptions of the clinical trials are different, the trials themselves are often substantially the same as those in the United States. Approval of a product by regulatory authorities of foreign countries must be obtained prior to commencing commercial product marketing in those countries, regardless of whether FDA approval has been obtained. The time and cost required to obtain market approvals in foreign countries may be longer or shorter than required for FDA approval and may be subject to delay. There can be no assurance that regulatory authorities of foreign countries will grant approval. The Company has no experience in manufacturing or marketing in foreign countries nor in matters such as currency regulations, import-export controls or other trade laws. PATENTS AND TRADEMARKS Premaire System Patents and Trademark Under its agreement with Siemens for the technology underlying the Premaire system, the Company is responsible for jointly financing and prosecuting the U.S. patent applications for the benefit of the owners and licensors of this technology. To date, nine U.S. patents have issued, and five corresponding foreign patents have been published. The issued U.S. patents provide protection through 2017 for the Premaire device, the dosator cartridges and their combinations. Also, a U.S. trademark was granted in 2001 registering the Premaire brand name, as well as Dosator(TM), and Misthaler(TM). -10- Tempo System Patents As of the December 31, 2001, three U.S. patents have issued and one has been allowed. Three corresponding foreign patents have been published. One U.S. and three foreign applications are in prosecution. The issued U.S. patents cover the Tempo flow control and triggering mechanism through 2018. The Company also received trademark protection in 2001 for the Tempo(TM) brand name. Early Stage Research Technology Patents Under its license agreements for its early stage research projects, the Company has been responsible for financing and prosecuting patent applications for the benefit of the owners and licensors of these technologies. While the Company holds, or has held, several U.S. and foreign patents and patent applications for these early stage technologies, the Company expects to assign these patents and applications to future acquirers, if any, of these technologies. Because the Company does not intend to continue to pay for future patent fees on these early stage technologies, in the event that no acquirers are found for these technologies, the Company expects that it will allow some or all of these patents and patent applications to lapse or the rights may be returned to the licensors. COMPETITION The Company competes with approximately 25 other companies involved in developing and selling respiratory products for the U.S. market. Most of these companies possess financial and marketing resources and developmental capabilities substantially greater than the Company. Some of the products in development by other companies may be demonstrated to be superior to the Company's current or future products. Furthermore, the pharmaceutical industry is characterized by rapid technological change and competitors may complete development and reach the marketplace prior to the Company. The Company believes that competition in the respiratory category will be based upon several factors, including product efficacy, safety, reliability, availability, and price, among others. SUBSIDIARIES On January 10, 1996, Ion Pharmaceuticals, Inc. ("Ion"), was formed as a wholly owned subsidiary of the Company. At that time, Ion acquired the Company's rights to certain early stage biomedical technologies. On April 17, 1997, CP Pharmaceuticals, Inc. ("CP") was formed for the purpose of acquiring Camelot Pharmacal, LLC ("Camelot"), a privately held pharmaceutical development company. The Company acquired Camelot on April 25, 1997. As part of its strategic alliance with Elan, on June 30, 1998, the Company formed SPD as a wholly owned subsidiary. At that time, SPD acquired the Company's rights to the systemic applications of the Premaire and the Tempo. In addition, SPD acquired Elan's rights to the UPDAS and the Enhancing Technology. SPD is responsible for the development of systemic applications in both the Premaire and Tempo. In addition to the above alliance with Elan, on October 18, 1999, the Company and Elan formed a new joint venture, RSD, to develop certain respiratory steroid products. The Company and Elan made equity investments in RSD representing an initial 80.1% and 19.9%, respectively, ownership in the joint venture. The joint venture is responsible for the development of the inhaled steroid products. EMPLOYEES As of March 25, 2002, the Company employed 16 persons, four of whom are executive officers. CERTAIN RISK FACTORS THAT MAY AFFECT FUTURE RESULTS, FINANCIAL CONDITION AND MARKET PRICE OF SECURITIES The following are some of the factors that could affect the Company's future results. They should be considered in connection with evaluating forward-looking statements contained in this report and otherwise made by the Company or on the Company's behalf, because these factors could cause actual results and conditions to differ materially from those projected in forward-looking statements. We have experienced significant operating losses throughout our history and expect these losses to continue for the foreseeable future. Our operations to date have consumed substantial amounts of cash and we have generated to date only limited revenues from contract research and licensing activities. We have incurred approximately $90.5 million of operating losses since our inception, including $9.7 million during the year ended December 31, 2001. Our operating losses and negative cash flow from operations are expected to continue in the foreseeable future. The Company expects that it will continue to have a high level of operating expenses, negative cash flow from operations and will be required to make significant up-front expenditures in connection with its product development activities. As a result, the Company anticipates additional operating losses for 2002 and that such losses will continue thereafter until such time, if ever, as the Company is able to generate sufficient revenues to sustain its operations. The independent auditors' report dated February 12, 2002, on the Company's consolidated financial statements stated that the Company has incurred recurring operating losses and has a working capital deficiency and that these conditions raise substantial doubt about its ability to continue as a going concern. We will need additional financing, which if not available, could prevent us from funding or expanding our operations. Cash available for funding our operations as of December 31, 2001 was $.9 million. As of such date, we had trade payables and accrued liabilities of $1.3 million, current research obligations of $.2 million and a note payable to Elan of $4 million. In addition, -11- committed and/or anticipated funding of research and development after December 31, 2001 is estimated at approximately $2.4 million, of which $2.0 million has been committed to be funded by Elan through the issuance of our Series E cumulative convertible preferred stock, which funds are required to be used by the Company to fund its portion of RSD's operating and development costs. Since December 31, 2001 we have received $1.0 million as a borrowing on the Loan and Security Agreement with Zambon, with an additional $.5 million available on April 1, 2002. We have also received $1.0 million from the issuance of 1,000 shares of Series E cumulative convertible preferred stock to fund our portion of RSD's costs. As of March 25, 2002, cash available for funding our operations was $1.2 million. We need to raise substantial additional capital to fund our operations. The development of our technologies and proposed products will require a commitment of substantial funds to conduct costly and time-consuming research, preclinical and clinical testing, and to bring any such products to market. Our future capital requirements will depend on many factors, including continued progress in developing and out-licensing our pulmonary delivery technologies, our ability to establish and maintain collaborative arrangements with others and to comply with the terms thereof, receipt of payments due from partners under research and development agreements, progress with preclinical and clinical trials, the time and costs involved in obtaining regulatory approvals, the cost involved in preparing, filing, prosecuting, maintaining and enforcing patent claims, the need to acquire licenses to new technology and the status of competitive products. We intend to seek such additional funding through collaborative or partnering arrangements, the extension of existing arrangements, or through public or private equity or debt financings. Additional financing may not be available on acceptable terms or at all. If we raise additional funds by issuing equity securities, stockholders may be further diluted and such equity securities might have rights, preferences and privileges senior to those of our current stockholders. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies, product candidates or products that we would otherwise seek to develop or commercialize. If adequate funds are not available from operations or additional sources of funding, our business will suffer a material adverse effect. If our common stock is delisted from the American Stock Exchange, the price of our common stock and its liquidity could decline. Our common stock is listed for trading on the American Stock Exchange, or AMEX, under the symbol "SHM". We do not satisfy AMEX guidelines for continued listing, including a guideline that a listed company that has sustained losses from operations and/or net losses in three of its four most recent fiscal years, have stockholders' equity of at least $4,000,000. We had a net capital deficiency of $9.1 million at December 31, 2001. We also do not satisfy a guideline against continued losses for each of the issuer's five most recent fiscal years. Our continued failure to meet the listing guidelines has been regularly reviewed by AMEX and may ultimately result in our common stock being delisted from AMEX. If our common stock were delisted from AMEX, trading of our common stock, if any, would thereafter likely be conducted in the over-the-counter market, unless we were able to list our common stock on The Nasdaq Stock Market or another national securities exchange, which cannot be assured. If our common stock were to trade in the over-the-counter market it may be more difficult for investors to dispose of, or to obtain accurate quotations as to the market value of our common stock. In addition, it may become more difficult for us to raise funds through the sale of our securities. In the event of the delisting of our common stock from the AMEX and our inability to list our common stock on The Nasdaq Stock Market or another national securities exchange, the regulations of the SEC under the Securities Exchange Act of 1934, as amended, require additional disclosure relating to the market for penny stocks. SEC regulations generally define a penny stock to be an equity security that has a market price of less than $5.00 per share, subject to certain exceptions. A disclosure schedule explaining the penny stock market and the risks associated therewith is required to be delivered to a purchaser and various sales practice requirements are imposed on broker-dealers who sell penny stocks to persons other than established customers and accredited investors (generally institutions). In addition, the broker-dealer must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customer's account. If our securities become subject to the regulations applicable to penny stocks, the market liquidity for our securities could be severely affected. In such an event, the regulations on penny stocks could limit the ability of broker-dealers to sell our securities. Our products are still in development and we may be unable to bring our products to market. We have not yet begun to generate revenues from the sale of products. Our products will require significant additional development, clinical testing and investment prior to their commercialization. We do not expect regulatory approval for commercial sales of any of our products in the immediate future. Potential products that appear to be promising at early stages of development may not reach the market for a number of reasons. Such reasons include the possibility that products will not be proven to be safe and efficacious in clinical trials, that they will not be able to meet applicable regulatory standards or obtain required regulatory approvals, that they cannot be produced in commercial quantities at reasonable costs or that they fail to be successfully commercialized or fail to achieve market acceptance. If our products are not accepted by the medical community, our business will suffer. -12- Commercial sales of our products will substantially depend upon the products' efficacy and on their acceptance by the medical community. Widespread acceptance of our products will require educating the medical community as to the benefits and reliability of the products. Our products may not be accepted and, even if accepted, we are unable to estimate the length of time it would take to gain such acceptance. We will be required to make royalty payments on products we may develop, reducing the amount of revenues with which we could fund ongoing operations. The owners and licensors of the technology rights acquired by us are entitled to receive a certain percentage of all revenues received by us from commercialization, if any, of products in respect of which we hold licenses. Accordingly, in addition to our substantial investment in product development, we will be required to make substantial payments to others in connection with revenues derived from commercialization of products, if any, developed under licenses we hold. Consequently, we will not receive the full amount of any revenues that may be derived from commercialization of products to fund ongoing operations. Our dependence on third parties for rights to technology and the development of our products could harm our business. Under the terms of existing license agreements, we are obligated to make certain payments to our licensors. In the event that we default on the payment of an installment under the terms of an existing licensing agreement, our rights there under could be forfeited. As a consequence, we could lose all rights under a license agreement to the related licensed technology, notwithstanding the total investment made through the date of the default. Unforeseen obligations or contingencies may deplete our financial resources and, accordingly, sufficient resources may not be available to fulfill our commitments. If we were to lose our rights to technology, we may be unable to replace the licensed technology or be unable to do so on commercially reasonable terms, which would materially adversely affect our ability to bring products based on that technology to market. In addition, we depend on our licensors for assistance in developing products from licensed technology. If these licensors fail to perform or their performance is not satisfactory, our ability to successfully bring products to market may be delayed or impeded. We face intense competition and rapid technological changes and our failure to successfully compete or adapt to changing technology could make it difficult to successfully bring products to market. The medical field is subject to rapid technological change and innovation. Pharmaceutical and biomedical research and product development are rapidly evolving fields in which developments are expected to continue at a rapid pace. Reports of progress and potential breakthroughs are occurring with increasing frequency. Our success will depend upon our ability to develop and maintain a competitive position in the research, development and commercialization of products and technologies in our areas of focus. Competition from pharmaceutical, chemical, biomedical and medical companies, universities, research and other institutions is intense and is expected to increase. All, or substantially all, of these competitors have substantially greater research and development capabilities, experience, and manufacturing, marketing, financial and managerial resources. Further, acquisitions of competing companies by large pharmaceutical or other companies could enhance such competitors' financial, marketing and other capabilities. Developments by others may render our products or technologies obsolete or not commercially viable and we may not be able to keep pace with technological developments. We are subject to significant government regulation and failure to achieve regulatory approval for our products would severely harm our business. Our ongoing research and development projects are subject to rigorous FDA approval procedures. The preclinical and clinical testing requirements to demonstrate safety and efficacy in each clinical indication (the specific condition intended to be treated) and regulatory approval processes of the FDA can take a number of years and will require us to expend substantial resources. We may be unable to obtain FDA approval for our products, and even if we do obtain approval, delays in such approval would adversely affect the marketing of products to which we have rights and our ability to receive product revenues or royalties. Moreover, even if FDA approval is obtained, a marketed product, its manufacturer and its manufacturing facilities are subject to continual review and periodic inspections by the FDA, and a later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions on such product or manufacturer. Failure to comply with the applicable regulatory requirements can, among other things, result in fines, suspensions of regulatory approvals, product recalls, operating restrictions and criminal prosecution. Additional government regulation may be established which could prevent or delay regulatory approval of our products. Sales of pharmaceutical products outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter than that required for FDA approval. We have no experience in manufacturing or marketing in foreign countries nor in matters such as currency regulations, import-export controls or other trade laws. To date, we have not received final regulatory approval from the FDA or any other comparable foreign regulatory authority for any of our products or technologies. Our failure to meet product release schedules would make it difficult to predict our quarterly results and may cause our operating results to vary significantly. -13- Delays in the planned release of our products may adversely affect forecasted revenues and create operational inefficiencies resulting from staffing levels designed to support the forecasted revenues. Our failure to introduce new products on a timely basis could delay or hinder market acceptance and allow competitors to gain greater market share. If our intellectual property and proprietary rights are infringed, or infringe upon the rights of others, our business will suffer. Our success will depend in part on our ability to obtain patent protection for our technologies, products and processes and to maintain trade secret protection and operate without infringing the proprietary rights of others. The degree of patent protection to be afforded to pharmaceutical, biomedical or medical inventions is an uncertain area of the law. In addition, the laws of foreign countries do not protect our proprietary rights to the same extent as do the laws of the United States. We may not develop or receive sublicenses or other rights related to proprietary technology that are patentable, patents that are pending may be not issued, and any issued patents may not provide us with any competitive advantages and may be challenged by third parties. Furthermore, others may independently duplicate or develop similar products or technologies to those developed by or licensed to us. If we are required to defend against charges of patent infringement or to protect our own proprietary rights against third parties, substantial costs will be incurred and we could lose rights to certain products and technologies or be required to enter into costly royalty or licensing agreements. We do not have any marketing or manufacturing capabilities and will likely rely on third parties for these capabilities in order to bring products to market. We do not currently have our own sales force or an agreement with another pharmaceutical company to market all of our products that are in development. When appropriate, we may build or otherwise acquire the necessary marketing capabilities to promote our products. However, we may not have the resources available to build or otherwise acquire our own marketing capabilities, and we may be unable to reach agreements with other pharmaceutical companies to market our products on terms acceptable to us, if at all. In addition, we do not intend to manufacture our own products. While we have already entered into two manufacturing and supply agreements related to the Premaire system and one related to the Tempo, these manufacturing and supply agreements may not be adequate and we may not be able to enter into future manufacturing and supply agreements on acceptable terms, if at all. Our reliance on independent manufacturers involves a number of risks, including the absence of adequate capacity, the unavailability of, or interruptions in, access to necessary manufacturing processes and reduced control over product quality and delivery schedules. If our manufacturers are unable or unwilling to continue manufacturing our products in required volumes, we will have to identify acceptable alternative manufacturers. The use of a new manufacturer may cause significant interruptions in supply if the new manufacturer has difficulty manufacturing products to our specifications. Further, the introduction of a new manufacturer may increase the variation in the quality of our products. Healthcare reimbursement policies are uncertain and may adversely impact the sale of our products. Our ability to commercialize human therapeutic and diagnostic products may depend in part on the extent to which costs for such products and technologies are reimbursed by private health insurance or government health programs. The uncertainty regarding reimbursement may be especially significant in the case of newly approved products. Reimbursement price levels may be insufficient to provide a return to us on our investment in new products and technologies. In the United States, government and other third-party payers have sought to contain healthcare costs by limiting both coverage and the level of reimbursement for new pharmaceutical products approved for marketing by the FDA, including some cases of refusal to cover such approved products. Healthcare reform may increase these cost containment efforts. We believe that managed care organizations may seek to restrict the use of new products, delay authorization to use new products or limit coverage and the level of reimbursement for new products. Internationally, where national healthcare systems are prevalent, little if any funding may be available for new products, and cost containment and cost reduction efforts can be more pronounced than in the United States. We may become subject to product liability claims and our product liability insurance may be inadequate. The use of our proposed products and processes during testing, and after approval, may entail inherent risks of adverse effects that could expose us to product liability claims and associated adverse publicity. Although we currently maintain general liability insurance, the coverage limits of our insurance policies may not be adequate. We currently maintain clinical trial product liability insurance of $2.0 million per event for certain clinical trials and intend to obtain insurance for future clinical trials of products under development. However, we may be unable to obtain or maintain insurance for any future clinical trials. Such insurance is expensive, difficult to obtain and may not be available in the future on acceptable terms, or at all. A successful claim brought against us in excess of our insurance coverage would have a material adverse effect upon us and our financial condition. We intend to require our licensees to obtain adequate product liability insurance. However, licensees may be unable to maintain or obtain adequate product liability insurance on acceptable terms and such insurance may not provide adequate coverage against all potential claims. The price of biotechnology/pharmaceutical company stocks has been volatile which could result in substantial losses to our stockholders. -14- The market price of securities of companies in the biotechnology/pharmaceutical industries has tended to be volatile. Announcements of technological innovations by us or our competitors, developments concerning proprietary rights and concerns about safety and other factors may have a material effect on our business or financial condition. The market price of our common stock may be significantly affected by announcements of developments in the medical field generally or our research areas specifically. The stock market has experienced volatility in market prices of companies similar to us that has been unrelated to the operating results of such companies. This volatility may have a material adverse effect on the market price of our common stock. Our ability to issue "blank check" preferred stock may make it more difficult for a change in our control. Our certificate of incorporation authorizes the issuance of "blank check" preferred stock with such designations, rights and preferences as may be determined from time to time by the Board of Directors, without shareholder approval. In the event of issuance, such preferred stock could be utilized, under certain circumstances, as a method of discouraging, delaying or preventing a change in our control and preventing shareholders from receiving a premium for their shares in connection with a change of control. We issued Series A and Series B cumulative convertible redeemable preferred stock in connection with private placements in February 1997 and April 1998, respectively. All of the Series A preferred stock was converted into common stock during 1998. On July 31, 1998, all of the Series B Preferred stock was redeemed for cash. We also issued shares of our Series C cumulative convertible preferred stock in connection with the consummation of an agreement with Elan International Services, Ltd. ("Elan International") in June 1998. In October 1999, in conjunction with a licensing agreement with Elan International, we issued shares of our Series D cumulative convertible exchangeable preferred stock and Series F cumulative convertible preferred stock. In addition, we also have a commitment from Elan International to purchase shares of Series E cumulative convertible non-exchangeable preferred stock at our option (subject to satisfaction of certain conditions). Except for the previously-mentioned purchase commitment for Series E preferred stock, and additional shares of Series C, D and E preferred stock that may be payable as dividends to Elan International, as holder of the outstanding Series C, D and E preferred stock, we have no present intention to issue any additional shares of our preferred stock. As we are currently investigating raising additional equity financing, we may issue additional shares of our preferred stock in the near future. We have granted anti-dilutions rights to The Tail Wind Fund Ltd. which may require us to issue additional shares to Tail Wind, make cash payments to Tail Wind and may hinder our ability to raise additional funds. Pursuant to our December 2000 private placement with The Tail Wind Fund Ltd., until at least August 29, 2002, if we sell shares of our common stock or securities convertible into or exercisable for common stock for less than $3.5888 per share, we are obligated to issue to Tail Wind additional shares so that the number of shares purchased by Tail Wind in the December 2000 private placement plus the additional shares issued to Tail Wind equals the number of shares that Tail Wind could have purchased for $2,250,000 at the price per share at which the new shares are sold. The presence of these anti-dilution rights may negatively affect our ability to obtain additional financing. In addition, in the event that we are required to issue additional shares to Tail Wind, we may not issue an aggregate of over 5,630,122 shares of our common stock in total to Tail Wind in connection with the December 2000 private placement. If we would otherwise be required to issue more than 5,630,122 shares to Tail Wind, we must instead pay Tail Wind 105% of the cash value of such shares we do not issue. We are obligated to issue additional securities in the future diluting our stockholders. As of December 31, 2001, we had reserved approximately 6,185,469 shares of our common stock for issuance upon exercise of outstanding options and warrants convertible into shares of our common stock, including by our officers and directors. In addition, as of December 31, 2001, we had $2,000,000 principal amount of a convertible promissory note, 14,708 shares of our Series C preferred stock, 13,779 shares of our Series D preferred stock, 2,124 shares of our Series E preferred stock and 5,000 shares of our Series F preferred stock outstanding. Except for Series D Preferred Stock, each of the convertible securities provides for conversion into shares of our common stock at a discount to the market price at December 31, 2001. Our Series C, D, E and F preferred stock are convertible into 10,431,206 shares, 2,839,300 shares, 546,015 shares and 1,470,588 shares, respectively, of common stock. The convertible promissory note, including accrued interest is convertible into 1,487,291 shares of common stock. The exercise of options and outstanding warrants, the conversion of such other securities and sales of common stock issuable thereunder could have a significant dilutive effect on the market price of our common stock and could materially impair our ability to raise capital through the future sale of our equity securities. -15- ITEM 2. PROPERTIES The Company's principal executive offices are located at 14528 South Outer Forty Road, Suite 205, St. Louis, Missouri 63017. These premises consist of approximately 6,193 square feet subject to a lease that expires December 14, 2002. The monthly rent for these premises is $10,838. The Company also maintains a research facility in Ann Arbor, Michigan, and leases a small office in Rochester, New York. The Company maintains no other laboratory, research or other facilities, but primarily conducts research and development in outside laboratories under contracts with universities or research facilities. The Company believes that its existing office arrangements will be adequate to meet its reasonably foreseeable future needs. ITEM 3. LEGAL PROCEEDINGS There are no material legal proceedings against the Company or any of its subsidiaries. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The following table sets forth the high and low sale prices of the Company's Common Stock on the American Stock Exchange (the "AMEX") for the periods indicated.
2001: High Low ------ ------ Fourth Quarter ................................ $4.750 $3.000 Third Quarter ................................. 4.110 2.680 Second Quarter ................................ 4.900 3.500 First Quarter ................................. 4.625 3.000 2000: High Low ------ ------ Fourth Quarter ................................ $6.625 $3.250 Third Quarter ................................. 6.875 4.250 Second Quarter ................................ 5.938 3.000 First Quarter ................................. 7.938 3.375
The closing sale price for the Company's Common Stock on the AMEX on March 25, 2002 was $2.27 per share. At March 25, 2002, there were approximately 401 holders of record of the Company's Common Stock. The Company has never paid dividends on its Common Stock and does not intend to pay cash dividends on its Common Stock in the foreseeable future. The terms of the Company's Series C, D and E Preferred Stock generally prohibit the payment of cash dividends and other distributions on the Company's Common Stock unless full cumulative stock dividends on shares of such Series C, D and E Preferred Stock have been paid or declared in full. During 2001, the Company issued stock dividends totaling 996, 929, and 120 shares and cash dividends for fractional shares of $3,278, $603, and $1,422 on Series C, D and E Preferred Stock, respectively. The following unregistered securities were issued by the Company during the quarter ended December 31, 2001:
NUMBER OF SHARES SOLD/ISSUED/ SUBJECT TO OFFERING/ DATE OF DESCRIPTION OF OPTIONS OR EXERCISE PRICE SALE/ISSUANCE SECURITIES ISSUED WARRANTS PER SHARES($) PURCHASER OR CLASS - ------------- ----------------- -- -------- -------------- ------------------ October 9, 2001 Common Stock, $.01 par value 14,367 $1.1206 Advisors in lieu of cash consideration
The issuance of these securities are claimed to be exempt from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended, as transactions by an issuer not involving a public offering. There were no underwriting discounts or commissions paid in connection with the issuance of any of these securities. -16- ITEM 6. SELECTED FINANCIAL DATA SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES (A DEVELOPMENT STAGE ENTERPRISE) SELECTED FINANCIAL INFORMATION (In dollars, except share information)
Years Ended December 31, 2001 2000 1999 1998 1997 ------------ ------------ ------------ ------------ ------------ CONSOLIDATED STATEMENT OF OPERATIONS DATA: Revenues: Contract research revenue $ 869,095 $ 501,572 $ 399,378 $ -- $ -- Sublicense revenue 5,000 5,000 -- 350,000 500,000 ------------ ------------ ------------ ------------ ------------ Total revenues 874,095 506,572 399,378 350,000 500,000 Expenses: Acquisition of research and development in-process technology -- -- 15,000,000 13,325,000 1,650,000 Research and development 5,999,693 3,747,437 3,421,734 2,351,301 3,729,193 General and administrative 4,551,661 2,817,535 2,277,136 3,043,070 4,627,567 ------------ ------------ ------------ ------------ ------------ Total expenses 10,551,354 6,564,972 20,698,870 18,719,371 10,006,760 ------------ ------------ ------------ ------------ ------------ Loss from operations (9,677,259) (6,058,400) (20,299,492) (18,369,371) (9,506,760) Interest income 58,438 124,908 91,941 60,273 56,914 Interest expense (318,642) (224,360) (162,237) (251,363) (39,292) Realized gain on sale of marketable securities 79,706 239,629 -- -- -- Minority interest in loss of subsidiary 378,620 155,072 2,985,000 -- -- ------------ ------------ ------------ ------------ ------------ Net loss $ (9,479,137) $ (5,763,151) $(17,384,788) $(18,560,461) $ (9,489,138) ============ ============ ============ ============ ============ Basic and diluted net loss per common share $ (.40) $ (.27)(1) $ (.68)(1) $ (.85) $ (.80) Basic and diluted weighted average common shares outstanding 28,963,562 27,956,119 27,236,715 21,931,040 11,976,090 CONSOLIDATED BALANCE SHEET DATA: Working capital (net deficiency) $ (4,160,823) $ 3,439,120 $ 3,344,174 $ 1,456,833 $ (837,564) Total assets 2,056,278 5,450,657 5,048,655 2,862,521 689,937 Long-term debt & redeemable preferred stock 5,000,000 4,000,000 3,000,000 1,000,000 4,019,263 Accumulated deficit (92,496,964) (80,967,524) (73,409,828) (55,156,763) (36,157,290) Stockholders' equity (net capital deficiency) $ (9,086,276) $ (413,720) $ 671,073 $ 655,205 $ (4,716,751)
- ---------- No cash dividends have been paid on Common Stock for any of the periods presented. Basic net loss per share is based on net loss available to common stockholders divided by the weighted average common stock outstanding during the year. See consolidated financial statements and accompanying footnotes. (1) As discussed in Note 1 ("Summary of Significant Accounting Policies - Basic Net Loss per Share of Common Stock") to the consolidated financial statements, basic and diluted net loss per share for the years ended December 31, 2000 and 1999 have been restated to properly reflect cumulative preferred stock dividends payable in kind in calculating the net loss available to common stockholders. -17- ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES (A DEVELOPMENT STAGE ENTERPRISE) MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion contains certain 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, which are intended to be covered by the safe harbors created thereby. All forward-looking statements involve risks and uncertainty, including without limitation, risks set forth in Part I of the Company's Form 10-K for the year ended December 31, 2001. The discussion and analysis below should be read in conjunction with the Financial Statements of the Company and the related Notes to Financial Statements included on pages 24-35 in this Form 10-K. OVERVIEW Sheffield Pharmaceuticals, Inc. ("Sheffield" or the "Company") provides innovative, cost-effective pharmaceutical therapies by combining state-of-the-art pulmonary drug delivery technologies with existing and emerging therapeutic agents. The Company is developing a range of products to treat respiratory and systemic diseases in its proprietary Premaire(R) Delivery System ("Premaire") and Tempo(TM) Inhaler ("Tempo"). The Company is in the development stage and, as such, has been principally engaged in the development of its pulmonary delivery systems. In 1997, the Company acquired the Premaire, a portable nebulizer-based pulmonary delivery system, through a worldwide exclusive license and supply arrangement with Siemens AG ("Siemens"). During the second half of 1998, the Company acquired the rights to an additional pulmonary delivery technology, Tempo, from a subsidiary of Aeroquip-Vickers, Inc. ("Aeroquip-Vickers"). The Tempo technology is a new generation propellant-based pulmonary delivery system. Additionally, during 1998, Sheffield licensed from Elan Corporation, plc ("Elan") the Ultrasonic Pulmonary Drug Absorption System ("UPDAS"), a novel disposable unit dose nebulizer system, and Elan's Absorption Enhancing Technology ("Enhancing Technology"), a therapeutic agent to increase the systemic absorption of drugs. In October 1999, the Company licensed Elan's Nanocrystal(TM) technology to be used in developing certain inhaled steroid products. Sheffield's lead drug delivery technology, the Premaire, is a patented, multi-dose nebulizer delivery system. The pocket-sized inhaled drug delivery system features an ultrasonic nebulizer that emits high-frequency sound waves that turn liquid medication into a fine cloud or soft mist. The Premaire combines the therapeutic benefits of nebulization with the convenience of pressurized metered dose inhalers, or pMDIs, in one patient-friendly device. The Premaire is comprised of a hand-held ultrasonic nebulizer and drug-filled cartridges that are inserted into the inhaler unit. The cartridges provide patients who must take multiple respiratory medications with a single, easy-to-use system. The Company believes the soft mist created by the Premaire provides multiple drug administration advantages over the high-velocity pMDIs and dry powder inhalers. Furthermore, the Premaire system is fast and portable as compared to conventional tabletop nebulizers, which are large, cumbersome and more time consuming to use. The Premaire system targets younger and older asthma patients, as well as older chronic obstructive pulmonary disease patients who have difficulty using pMDIs and currently depend on tabletop nebulizers for delivery of their medications. Sheffield's Tempo is a patented, new generation pMDI that the Company believes has significant efficiency and performance advantages over standard pMDIs. The Tempo technology utilizes a standard aerosol pMDI canister, encased in a compact device that provides an aerosol flow-control chamber and a synchronized triggering mechanism. The aerosol flow-control chamber allows the patient to inhale through the device at a normal breathing rate, instead of a forced breath. The inspiratory breath establishes flow fields within the device that mix and uniformly disperse the drug in the breath. At the mouthpiece, nearly all the propellant is evaporated leaving only drug particles to be inspired, allowing a significant increase in the amount of drug delivered to the lungs. The Tempo system, like the Premaire system, is designed to reduce patient coordination problems and enhance compliance with the prescribed treatment. In June 1998, the Company sublicensed to Zambon Group SpA ("Zambon") worldwide marketing and development rights to respiratory products to be delivered by the Premaire in return for an equity investment in the Company (approximately 10%). From June 1998 to September 2001, Zambon funded the development costs for the respiratory compounds delivered by Premaire. In September 2001, the Company amended its 1998 agreement with Zambon whereby Sheffield regained the rights to the Premaire previously granted to Zambon. As part of the amended agreement, Zambon provided a low-interest, $2.5 million loan to Sheffield to progress the development of the Premaire respiratory program. Upon commercialization, Zambon will be entitled to certain royalties on payments received by Sheffield for albuterol, ipratropium and cromolyn sales for specified periods. As part of a strategic alliance with Elan, the Company is developing therapies for non-respiratory diseases to be delivered to the lungs using both Tempo and Premaire. In 1998, the systemic applications of Premaire and Tempo were licensed to Systemic Pulmonary -18- Delivery, Ltd. ("SPD"), a wholly owned subsidiary of the Company. In addition, two Elan technologies, UPDAS(TM) and the Enhancing Technology, were also licensed to SPD. The Company retained exclusive rights outside of the strategic alliance to respiratory disease applications utilizing the Tempo technology and the two Elan technologies. In addition to the above alliance with Elan, in 1999, the Company and Elan formed a joint venture, Respiratory Steroid Delivery, Ltd. ("RSD"), to develop certain inhaled steroid products to treat respiratory diseases using Elan's NanoCrystal technology. Currently, RSD is developing a solution-based unit-dose-packaged steroid formulation for delivery using a conventional tabletop nebulizer, and a solution-based steroid formulation for delivery using the Premaire. CRITICAL ACCOUNTING POLICIES Basis of Presentation The Company is in the development stage and to date has been principally engaged in research, development and licensing efforts. The Company has generated minimal operating revenue and will require additional capital, which the Company intends to obtain through out-licensing of rights to its technology, as well as through equity and debt offerings, to continue to operate its business. The Company's ability to meet its obligations as they become due and to continue as a going concern must be considered in light of the expenses, difficulties and delays frequently encountered in developing a new business, particularly since the Company will focus on research, development and unproven technology that may require a lengthy period of time and substantial expenditures to complete. Even if the Company is able to successfully develop new products, there can be no assurance that the Company will generate sufficient revenues from the sale or licensing of such products to be profitable. Management believes that the Company's ability to meet its obligations as they become due and to continue as a going concern through December 2002 is dependent upon obtaining additional funding. The Company's consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. Should the Company not be successful in obtaining sufficient funding, some of the assets and liabilities may not be satisfied at the current carrying values. The consolidated financial statements include the accounts of Sheffield and its wholly owned subsidiaries, Systemic Pulmonary Delivery, Ltd. ("SPD"), Ion Pharmaceuticals, Inc., and CP Pharmaceuticals, Inc., and its 80.1% owned subsidiary, Respiratory Steroid Delivery, Ltd. ("RSD"). Deferred Tax Assets As of December 31, 2001, the Company has approximately $21.2 million of deferred tax assets, the majority of which relates to net operating loss carryforwards that expire at various dates from 2007 to 2021 if not utilized. The realization of these assets is dependent upon the Company generating future taxable income. Due to the uncertainty of the amount, if any, of future taxable income that may be generated, the Company has recorded a valuation allowance for the entire deferred tax asset. Should the Company generate sufficient future taxable income before the net operating loss carryforwards expire, the benefit of the deferred tax asset will be realized at that time. RESULTS OF OPERATIONS Revenue Contract research revenues primarily represented revenues earned from a collaborative research agreement with Zambon relating to the development of respiratory applications of Premaire. Contract research revenue was $869,095, $501,572 and $399,378 for the years ended December 31, 2001, 2000 and 1999, respectively. The increase of $367,523, or 73.3% from 2000 to 2001 reflects higher revenues associated with Premaire device development work and testing as the Company finalizes the to-be-marketed device prior to the start of Phase III Premaire-albuterol clinical trials. These higher revenues were partially offset by the Company no longer performing development work for Zambon in the third and fourth quarters of 2001, resulting from Sheffield regaining the Premaire respiratory rights in the third quarter of 2001. The increase of $102,194, or 25.6% from 1999 to 2000 reflects two additional Premaire respiratory programs in development in 2000 as compared to 1999 and certain nonrecurring Premaire device development work and testing completed during 2000. Costs of contract research revenue approximated such revenues and were included in research and development expenses. Future contract research revenues and expenses are dependent on obtaining additional collaborative agreements. The Company's ability to generate material revenues is contingent on the successful commercialization of its technologies and other technologies and products that it may acquire, followed by the successful marketing and commercialization of such technologies through licenses, joint ventures and other arrangements. Acquisition of Research & Development In-Process Technology -19- In 1999, the Company licensed certain pulmonary NanoCrystal technology from Elan for $15.0 million. This entire payment was expensed as the license agreement restricts the Company's use of the NanoCrystal technology to certain respiratory steroid products that are currently research and development projects. Research and Development Research and development expenses were $6.0 million for the year ended December 31, 2001 compared to $3.7 million and $3.4 million for the years ended December 31, 2000 and 1999, respectively. The increase of $2.3 million, or 60.1%, primarily reflects higher expenses associated with the development of the Company's unit-dose inhaled steroid product reflecting increased formulation work and the start of a Phase I clinical trial during the fourth quarter ($1.2 million), costs associated with the Company's feasibility work associated with new product development in the area of polypeptides ($.5 million), higher costs related to the industrialization of the Tempo Inhaler ($.4 million), and increased design and development costs associated with finalizing the to-be-marketed Premaire device prior to the start of a Phase III albuterol-clinical trial ($.2 million). The increase of $.3 million, or 9.5%, from 1999 to 2000 primarily represents costs associated with the development by the Company's subsidiary, RSD, of three steroid products initiated during the fourth quarter of 1999 ($.7 million), formulation work begun during 2000 on a respiratory product to be delivered via the Tempo ($.5 million), modifications made to the Premaire to enhance its commercial appeal prior to the start of Phase III-albuterol clinical trials ($.3 million), and two additional Premaire respiratory programs in development in 2000 as compared to 1999 ($.1 million). These increases were partially offset by lower development costs on the Company's two systemic programs, a therapy for breakthrough pain delivered through the Premaire ($.3 million), and a migraine therapy delivered through the Tempo ($1.0 million). The following details the status of each of the Company's development programs as of December 31, 2001: Premaire Respiratory Program: As a result of the Company regaining from Zambon the rights to the respiratory applications to the Premaire in September 2001, the sponsorship of the Premaire respiratory development programs was transferred from Zambon to the Company with the Food and Drug Administration ("FDA") being notified accordingly. In the fourth quarter of 2001, Sheffield reviewed all of the development work completed-to-date, identifying a number of deficiencies in the Zambon development program. To address these issues, Sheffield has made a number of internal management changes and moved the program to a group of highly experienced pulmonary clinical and regulatory experts. The Premaire device is currently in a to-be-marketed form and fully industrialized. As of December 31, 2001, the Company had spent $3.1 million on developing the respiratory products discussed below. The Company's strategy is to out license the U.S. rights to the Premaire respiratory products to a third party which the Company anticipates concluding in 2003. As a result, the Company estimates a U.S. commercial launch of its first products in Premaire to occur in the last half of 2005 or first half of 2006. Sheffield will fund the continued development work for the Premaire respiratory products up through the period of outlicensing, currently estimated at approximately $10 million, after which time the licensee will assume funding responsibility for further development work. Albuterol Sulfate. Zambon initiated a Phase II clinical trial in December 1999 that compared the Premaire-albuterol sulfate to a conventional albuterol-pMDI. Findings from Phase II studies indicated that Premaire-albuterol and pMDI-albuterol were comparable in improving lung function in the 24 adult patients. An end of Phase II meeting was held in February 2002 with the FDA where the results of the development activities-to-date, specifically the results of the Phase II trial, were reviewed. The Company is currently reviewing the FDA's comments and recommendations, integrating the information into the plans for the Phase III trial and NDA submission. The Company expects to begin pivotal clinical trials for the albuterol sulfate program by the end of 2002. Budesonide. Preclinical formulation development work is currently underway. A formulation developed by Nanosystems has proven a feasible candidate for delivery in the Premaire. The formulation is dependent on a proprietary nanocrystaline dispersion of budesonide in an aqueous carrier. Two other alternative formulation approaches are also under evaluation. Upon scale-up and production of clinical batches released under CMC protocol, an IND will be prepared for filing with the FDA, which is currently planned for the first half of 2003. Ipratropium Bromide. Zambon initiated a Phase I/II clinical trial in Europe in January 2000 assessing the safety and efficacy compared to a commercially available ipratropium bromide product delivered by a pMDI and placebo in patients with COPD. The results of the study indicated that both Premaire-ipratropium bromide and pMDI-ipratropium were tolerated and improved lung function in the COPD patients. An Investigational New Drug Application ("IND") was filed by Zambon with the FDA in May 2000. During 2001, the IND was transferred to the Company. The Company does not intend to further develop this product on its own as the program has progressed to the point where a potential licensing partner would be in a position to take the product into clinical studies. Sodium Cromoglycate. An IND was filed by Zambon with the FDA in July 2000. No further development work is anticipated to be completed on this product as the projected market opportunity for sodium cromoglycate is currently deemed too small to justify further progression. -20- Premaire Systemic Program: Through its development alliance with Elan, SPD, the Company evaluated certain drugs for systemic treatment by pulmonary delivery through Premaire. By identifying a market opportunity for a rapid-acting, non-invasive treatment for breakthrough pain, the first drug to be tested for delivery in Premaire was morphine. In July 1999, the Company completed a gamma scintigraphy/pharmacokinetic trial comparing morphine delivered using the Premaire to subcutaneous injection. The Premaire demonstrated good pulmonary deposition and very rapid absorption, more rapid peak blood levels vs. subcutaneous injection and low oral and throat deposition. As part of the development alliance with Elan, Elan has the first right of refusal on the development of any product developed by the joint venture. Elan has chosen not to license this product from the joint venture. As such, the joint venture continues to seek to attract a partner for the continued development and commercialization of this product. The Company has spent $.4 million to date to develop this product and does not anticipate incurring any future costs for further development until such time as a licensing partner is secured. Tempo Respiratory Program: In September 2000, the Company completed a pilot study using the Tempo to deliver an undisclosed, patented respiratory drug used to treat asthma. The study measured the distribution of this respiratory drug delivered by Tempo compared to the distribution of this same drug delivered through a commercially available pMDI in 12 healthy volunteers. Results of this study demonstrated that Tempo significantly increased drug deposition in all regions of the lung. Tempo delivered approximately 200% more drug to the lungs, deposited approximately 75% less drug in the mouth, and increased dosing consistency by approximately 55% compared to the currently marketed form of this same drug. As of December 31, 2001, the Company has incurred approximately $.9 million to-date on this study. The Company is using the results of this study as a basis for conducting discussions for feasibility work and/or clinical studies with potential collaboration partners. Tempo Systemic Program: The development of systemic drugs using Tempo is being conducted as part of the Company's alliance with Elan. The initial product developed was targeted to address migraine headaches. The Company utilized ergotamine tartrate as a proof-of-principle product. In December 1999, the Company completed a gamma scintigraphy/pharmacokinetic trial comparing the Tempo to a conventional pMDI. The trial showed successful delivery of the drug to all regions of lung with significantly reduced mouth and throat deposition, and rapid drug absorption. As part of the development alliance with Elan, Elan has the first right of refusal on the development of any product developed by the joint venture. Elan has chosen not to license this product from the joint venture. As such, the joint venture continues to seek to attract a partner for the continued development and commercialization of this product. As of December 31, 2001, the Company has spent $1.0 million to date to develop this product and does not anticipate incurring any future costs for further development until such time as a licensing partner is secured. As a result of the work performed on the ergotamine product noted above, during 2001 Sheffield initiated a new development program for a novel formulation of dyhydroergotamine ("DHE") for pulmonary delivery in the Tempo for the treatment of specific types of migraines. Formulation work for this program is currently underway. As of December 31, 2001, the Company has incurred approximately $.1 million to-date related to this project. The Company is currently in discussions with a pharmaceutical company for the development and manufacturing of this product. Future costs related to this project are dependent, among other factors, the timing of securing a development partner. The Company estimates incurring approximately $3 million in 2002 related to the development of the DHE project. Unit Dose Nebulizer Program: As part of an alliance with Elan, RSD is developing a product for inhalation delivery in a standard commercial tabletop device using the steroid budesonide, formulated using the NanoCrystal technology. A Phase I, double-blind safety and pharmacokinetic study of nebulized nanobudesonide in 16 healthy volunteers was satisfactorily completed at Thomas Jefferson University Hospital in February 2002. This study compared single doses of Pulmicort Respules, nanobudesonide and placebo. Data from the study is currently undergoing final data and statistical analysis. After such data has been analyzed, the Company plans on initiating discussions with potential partners regarding the outlicensing of this opportunity. As of December 31, 2001, the Company incurred approximately $2.1 million to-date on this project. Sheffield will fund the continued development work for this program up through the period of outlicensing, currently estimated at approximately $2.5 million, after which time it is anticipated that the licensee will assume funding responsibility for further development work. General and Administrative Expenses General and administrative expenses were $4.6 million for the year ended December 31, 2001 compared to $2.8 million and $2.3 million for the years ended December 31, 2000 and 1999, respectively. The increase of $1.8 million, or 61.5%, from 2000 to 2001 was primarily due to higher consulting costs and legal fees associated with expanded business development and merger and acquisition activities -21- in the area of licensing and partnering of the Company's delivery systems, as well as potential acquisitions of complementary pulmonary delivery technologies and companies. The increase of $.5 million, or 23.7%, from 1999 to 2000 primarily reflects higher consulting and legal costs associated with expanded business development activities. Interest Interest income was $58,438 for the year ended December 31, 2001 as compared to $124,908 and $91,941 for the years ended December 31, 2000 and 1999, respectively. The decrease of $66,470, or 53.2%, from 2000 to 2001 is primarily due to less cash available for investment and lower yields on those investments. The $32,967 increase in interest income in 1999 from 1998 was primarily due to larger balances of cash available for investment and higher average yields on those investments. Interest expense was $318,642 for the year ended December 31, 2001 as compared to $224,360 and $162,237 for the years ended December 31, 2000 and 1999, respectively. The increase of $94,282, or 42.0%, from 2000 to 2001 resulted primarily from higher short-term borrowings reflecting the August 2001 $4.0 million promissory note with Elan Pharma International Ltd. ("Elan Pharma"). The increase of $62,123 from 2000 to 1999 resulted from a higher outstanding balance during 2000 on the Company's convertible promissory note with Elan, as well as a higher average interest rate on the note. Realized Gain on Sale of Marketable Securities Realized gain on sale of marketable securities was $79,706 and $239,629 for the years ended December 31, 2001 and 2000, respectively. These gains resulted from the sale of 283,188 and 300,000 shares for 2001 and 2000, respectively, of the Company's investment in Lorus Therapeutics, Inc. ("Lorus"). As of December 31, 2001, the Company had no remaining investment in Lorus. Minority Interest in Subsidiary Minority interest in loss of subsidiary was $.4 million for the year ended December 31, 2001 compared to $.2 million and $3.0 million for the years ended December 31, 2000 and 1999, respectively. RSD, a consolidated and 80.1% owned subsidiary of the Company, incurred a loss of $1.9 million and $.8 million in 2001 and 2000, respectively. The $1.1 million increase from 2000 to 2001 resulted primarily from costs associated with initiation of a Phase I/II clinical study of the inhaled steroid product delivered using a tabletop nebulizer. RSD's loss of $15.0 million in 1999 resulted from the license of certain pulmonary NanoCrystal technology from Elan. The minority interest in loss of subsidiary represents Elan's portion, or 19.9%, of RSD's losses. Elan's investment in RSD, shown as minority interest in subsidiary on the consolidated balance sheets, was $0 at both December 31, 2001 and 2000, respectively. LIQUIDITY AND CAPITAL RESOURCES At December 31, 2001, the Company had $.9 million in cash and cash equivalents compared to $3.0 million at December 31, 2000. The decrease of $2.1 million reflects $9.1 million of cash disbursements used primarily to fund operating activities and $.6 million to repurchase and retire 214,997 shares of the Company's Common Stock. These decreases in cash were partially offset by the receipt of a $1.0 million milestone advance from Zambon, $1.0 million from the issuance of 1,000 shares of the Company's Series E Cumulative Convertible Preferred Stock, $4.0 million from the proceeds of an unsecured promissory note from Elan Pharma, $1.0 million from the proceeds of a secured loan from Zambon, and $.5 million in net proceeds from the exercise of common stock options and warrants. In September 2001, in connection with the amendment of its 1998 agreement with Zambon, the Company entered into a Loan and Security Agreement ("Loan Agreement") with Zambon, pursuant to which Zambon agreed to lend the Company $2.5 million. The Company received $1.0 million upon signing of the Loan Agreement, with additional borrowings of $1.0 million and $.5 million to be made on January 1, 2002 and April 1, 2002, respectively. The Loan Agreement provides for interest on principal and annually compounded interest at a fixed rate of 2% per annum and is secured by certain security interests in respiratory products developed in the Premaire. One third of the principal balance, together with interest, is payable by the Company upon the Company's execution of an agreement with one or more third parties to develop, co-promote and/or sell certain products in North America, with all remaining unpaid principal and interest due on December 31, 2005. As part of the amendment of its 1998 agreement with Zambon, on October 17, 2001 the Company repurchased from Zambon 214,997 shares of common stock for $3.0233 per share ("Repurchase Price"). In addition, the Company received an option, expiring December 31, 2002, to repurchase the remaining shares of the Company's common stock held by Zambon at the Repurchase Price. In the event the Company completes a sublicense for the North American rights or a sublicense for the non-North American rights to certain Premaire respiratory products prior to December 31, 2002, the Company will be required to repurchase from Zambon 882,051 shares of the Company's common stock on each of the events. In August 2001, the Company entered into a Note Purchase Agreement with Elan Pharma, pursuant to which Elan Pharma agreed to lend the Company $4 million. All borrowings under the Note Purchase Agreement are evidenced by an unsecured promissory note of the Company that provides for interest on principal and semi-annually compounded interest at a fixed rate of 10% per annum and a maturity of November 14, 2002, or upon the earlier occurrence of one or more specified events. -22- In October 1999, as part of a licensing agreement with Elan, the Company received gross proceeds of $17.0 million related to the issuance to Elan of 12,015 shares of Series D Cumulative Convertible Exchangeable Preferred Stock and 5,000 shares of Series F Convertible Non-Exchangeable Preferred Stock. In turn, the Company made an equity investment of $12.0 million in a joint venture, RSD, representing an initial 80.1% ownership. The remaining proceeds from this preferred stock issuance were available for general operating purposes. As part of the agreement, Elan also committed to purchase, on a drawdown basis, up to an additional $4.0 million of the Company's Series E Preferred Stock, of which $2.0 million of such commitment remains outstanding. The proceeds from the Series E Preferred Stock are required to be utilized by the Company to fund its portion of RSD's operating and development costs. In May 1999, in conjunction with the completion of its Phase I/II Premaire-albuterol trial, Zambon provided the Company with a $1.0 million interest-free advance against future milestone payments. In January 2001, the Company received an additional $1.0 million interest-free milestone advance resulting from the demonstration of the technical feasibility of delivering an inhaled steroid formulation in Premaire. The proceeds from these advances were not restricted as to their use by the Company. As part of the amendment of its 1998 agreement with Zambon, the terms of the milestone advances were modified in that the Company agreed to repay $1.0 million of the advance milestone payments upon the earlier of December 31, 2003, or upon the first regulatory approval for either albuterol or an inhaled steroid delivered in the Premaire. The remaining $1.0 million advance shall be repaid by the Company on the earlier of December 31, 2005, or the regulatory approval of the second product (albuterol or an inhaled steroid) delivered in the Premaire. Due to the modification in the repayment terms, the advances have been reclassified in the Company's balance sheet as long-term debt. Since its inception, the Company has financed its operations primarily through the sale of securities and convertible debentures, from which it has raised an aggregate of approximately $84.0 million through December 31, 2001, of which approximately $30.0 million has been spent to acquire certain in-process research and development technologies, and $34.8 million has been incurred to fund certain ongoing technology research projects. The Company expects to incur additional costs in the future, including costs relating to its ongoing research and development activities, and preclinical and clinical testing of its product candidates. The Company may also bear considerable costs in connection with filing, prosecuting, defending and/or enforcing its patent and other intellectual property claims. Therefore, the Company will need substantial additional capital before it will recognize significant cash flow from operations, which is contingent on the successful commercialization of the Company's technologies. There can be no assurance that any of the technologies to which the Company currently has or may acquire rights can or will be commercialized or that any revenues generated from such commercialization will be sufficient to fund existing and future research and development activities. As of March 25, 2002, the Company had $1.2 million in cash available to fund its operations. As stated above, the Company is to receive $.5 million on April 1, 2002 pursuant to its Loan Agreement with Zambon and the Company has an agreement to receive $1.0 million from Elan to fund the Company's portion of RSD's operating and development costs. Because the Company does not currently have, and does not expect to generate, significant cash flows from operations for at least the next few years, the Company will require additional funds to meet the costs of its development programs for 2002 and beyond. In an effort to meet its capital requirements, the Company is currently pursuing various financing alternatives including private offerings of its securities, debt financing, and collaboration and licensing arrangements with other companies. There can be no assurance that the Company will be able to obtain such additional funds or enter into such collaborative and licensing arrangements on terms favorable to the Company, if at all. The Company's development programs will be curtailed if future financings are not completed. While the Company does not believe that inflation has had a material impact on its results of operations, there can be no assurance that inflation in the future will not impact financial markets which, in turn, may adversely affect the Company's valuation of its securities and, consequently, its ability to raise additional capital, either through equity or debt instruments, or any off-balance sheet refinancing arrangements, such as collaboration and licensing agreements with other companies. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK The Company has no material market risk exposure. -23- ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA REPORT OF INDEPENDENT AUDITORS The Board of Directors and Stockholders Sheffield Pharmaceuticals, Inc. We have audited the accompanying consolidated balance sheets of Sheffield Pharmaceuticals, Inc. and Subsidiaries (a development stage enterprise) as of December 31, 2001 and 2000, and the related consolidated statements of operations, stockholders' equity (net capital deficiency), and cash flows for each of the three years in the period ended December 31, 2001 and for the period October 17, 1986 (inception) through December 31, 2001. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Sheffield Pharmaceuticals, Inc. and Subsidiaries at December 31, 2001 and 2000, and the consolidated results of their operations and their cash flows for each of the three years in the period ended December 31, 2001 and the period from October 17, 1986 (inception) through December 31, 2001, in conformity with accounting principles generally accepted in the United States. The accompanying financial statements have been prepared assuming that Sheffield Pharmaceuticals, Inc. and Subsidiaries will continue as a going concern. As more fully described in Note 1, the Company has incurred recurring operating losses and has a working capital deficiency. Those conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. As discussed in Note 1, the computation of basic and diluted net loss per share of common stock for the years ended December 31, 2000 and 1999 has been restated. /s/ Ernst & Young LLP St. Louis, Missouri February 12, 2002 -24- SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES (a development stage enterprise) CONSOLIDATED BALANCE SHEETS
ASSETS December 31, ------------ 2001 2000 ------------ ------------ Current assets: Cash and cash equivalents (Note 1) $ 859,298 $ 3,041,948 Marketable equity securities (Notes 1 and 6) -- 327,422 Milestone advance receivable (Note 5) -- 1,000,000 Clinical supplies 427,550 236,000 Prepaid expenses and other current assets 86,080 304,272 ------------ ------------ Total current assets 1,372,928 4,909,642 ------------ ------------ Property and equipment (Note 1): Laboratory equipment 431,920 271,748 Office equipment 245,019 211,609 Leasehold improvements 25,309 18,320 ------------ ------------ Total at cost 702,248 501,677 Less accumulated depreciation and amortization (355,014) (235,389) ------------ ------------ Property and equipment, net 347,234 266,288 ------------ ------------ Patent costs, net of accumulated amortization of $20,216 and $9,287, respectively (Note 1) 308,203 258,897 Other assets 27,913 15,830 ------------ ------------ Total assets $ 2,056,278 $ 5,450,657 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY (NET CAPITAL DEFICIENCY) Current liabilities: Accounts payable $ 856,216 $ 791,722 Accrued liabilities 441,778 443,043 Sponsored research payable 235,757 235,757 Note payable (Note 5) 4,000,000 -- ------------ ------------ Total current liabilities 5,533,751 1,470,522 Convertible promissory note (Note 5) 2,000,000 2,000,000 Long-term debt (Note 5) 3,000,000 2,000,000 Other long-term liabilities 608,803 393,855 Commitments and contingencies -- -- ------------ ------------ Total liabilities 11,142,554 5,864,377 Minority interest in subsidiary (Note 1) -- -- Stockholders' equity (net capital deficiency) (Notes 3 & 4): Preferred stock, $.01 par value, authorized 3,000,000 shares: Series C cumulative convertible preferred stock, authorized 23,000 shares; 14,708 and 13,712 shares issued and outstanding at December 31, 2001 and 2000, respectively 147 137 Series D cumulative convertible exchangeable preferred stock, authorized 21,000 shares; 13,799 and 12,870 shares issued and outstanding at December 31, 2001 and 2000, respectively 138 129 Series E cumulative convertible non-exchangeable preferred stock, authorized 9,000 shares; 2,124 and 1,004 shares issued and outstanding at December 31, 2001 and 2000, respectively 21 10 Series F convertible non-exchangeable preferred stock, 5,000 shares authorized; 5,000 shares issued and outstanding at December 31, 2001 and 2000 50 50 Common stock, $.01 par value, authorized 100,000,000 shares; issued and outstanding 29,001,602 and 28,791,643 shares at December 31, 2001 and 2000, respectively 290,016 287,916 Additional paid-in capital 83,120,316 80,108,095 Other comprehensive income -- 157,467 Deficit accumulated during development stage (92,496,964) (80,967,524) ------------ ------------ Total stockholders' equity (net capital deficiency) (9,086,276) (413,720) ------------ ------------ Total liabilities and stockholders' equity (net capital deficiency) $ 2,056,278 $ 5,450,657 ============ ============
See notes to consolidated financial statements. -25- SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES (a development stage enterprise) CONSOLIDATED STATEMENTS OF OPERATIONS For the Years Ended December 31, 2001, 2000 and 1999 and for the Period from October 17, 1986 (inception) to December 31, 2001
October 17, 1986 Years ended December 31, (inception) to ------------------------ December 31, 2001 2000 1999 2001 ------------ ------------ ------------ ------------ Revenues: Contract research revenue (Note 1) $ 869,095 $ 501,572 $ 399,378 $ 1,770,045 Sublicense revenue (Note 6) 5,000 5,000 -- 1,370,000 ------------ ------------ ------------ ------------ Total revenues 874,095 506,572 399,378 3,140,045 Expenses: Acquisition of research and development in-process technology (Note 6) -- -- 15,000,000 29,975,000 Research and development 5,999,693 3,747,437 3,421,734 34,772,555 General and administrative 4,551,661 2,817,535 2,277,136 28,886,746 ------------ ------------ ------------ ------------ Total expenses 10,551,354 6,564,972 20,698,870 93,634,301 ------------ ------------ ------------ ------------ Loss from operations (9,677,259) (6,058,400) (20,299,492) (90,494,256) Interest income 58,438 124,908 91,941 789,387 Interest expense (318,642) (224,360) (162,237) (1,116,357) Realized gain (loss) on sale of marketable securities 79,706 239,629 -- (5,580) Minority interest in loss of subsidiary (Note 1) 378,620 155,072 2,985,000 3,518,693 ------------ ------------ ------------ ------------ Loss before extraordinary item (9,479,137) (5,763,151) (17,384,788) (87,308,113) Extraordinary item -- -- -- 42,787 ------------ ------------ ------------ ------------ Net loss $ (9,479,137) $ (5,763,151) $(17,384,788) $(87,265,326) ============ ============ ============ ============ Preferred stock dividends (2,084,392) (1,830,094) (1,036,487) (5,729,520) Accretion of mandatorily redeemable preferred stock -- -- -- (103,400) ------------ ------------ ------------ ------------ Net loss - attributable to common shares $(11,563,529) $ (7,593,245) $(18,421,275) $(93,098,246) ============ ============ ============ ============ Basic and diluted weighted average common shares outstanding (Note 1) 28,963,562 27,956,119 27,236,715 10,621,036 Basic and diluted net loss per share of common stock (Note 1): $ (.40) $ (.27) $ (.68) $ (8.77)
See notes to consolidated financial statements. -26- SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES (a development stage enterprise) CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (NET CAPITAL DEFICIENCY) For the Period from October 17, 1986 (Inception) to December 31, 2001
Notes receivable in connection with Additional Preferred Common sale of paid-in Stock Stock stock capital ------------ ------------ ------------------ ------------ Balance at October 17, 1986 $ -- $ -- $ -- $ -- Common stock issued -- 11,484,953 100,000 30,539,185 Reincorporation in Delaware at $.01 par value -- (11,220,369) -- 11,220,369 Common stock subscribed -- -- (110,000) -- Common stock options and warrants issued -- -- -- 240,868 Issuance of common stock in connection with acquisition of Camelot Pharmacal, LLC -- 6,000 -- 1,644,000 Common stock options extended -- -- -- 215,188 Accretion of issuance costs for Series A preferred stock -- -- -- -- Series C preferred stock issued 115 -- -- 11,499,885 Series C preferred stock dividends 4 -- -- 413,996 Comprehensive income (loss): Unrealized loss on marketable securities -- -- -- -- Net loss -- -- -- -- Comprehensive income (loss) -- -- -- -- ------------ ------------ ------------ ------------ Balance at December 31, 1998 119 270,584 (10,000) 55,773,491 Common stock issued -- 2,504 10,000 89,059 Series C preferred stock dividends 9 -- -- 865,991 Series D preferred stock issued 120 -- -- 12,014,880 Series F preferred stock issued 50 -- -- 4,691,255 Common stock warrants issued -- -- -- 203,452 Comprehensive income (loss): Unrealized gain on marketable securities -- -- -- -- Net loss -- -- -- -- Comprehensive income (loss) -- -- -- -- ------------ ------------ ------------ ------------ Balance at December 31, 1999 298 273,088 -- 73,638,128 Common stock issued -- 15,738 -- 3,796,072 Repurchase and retirement of common stock -- (910) -- (312,279) Series C preferred stock dividends 9 -- -- 931,991 Series D preferred stock dividends 9 -- -- 854,991 Series E preferred stock issued 10 -- -- 999,990 Series E preferred stock dividends -- -- -- 4,000 Common stock warrants issued -- -- -- 195,202 Comprehensive income (loss): Unrealized loss on marketable securities -- -- -- -- Net loss -- -- -- -- Comprehensive income (loss) -- -- -- -- ------------ ------------ ------------ ------------ Balance at December 31, 2000 326 287,916 -- 80,108,095 Common stock issued -- 4,251 -- 481,201 Repurchase and retirement of common stock -- (2,151) -- (640,691) Series C preferred stock dividends 10 -- -- 995,990 Series D preferred stock dividends 9 -- -- 928,991 Series E preferred stock issued 10 -- -- 999,990 Series E preferred stock dividends 1 -- -- 119,999 Common stock warrants issued -- -- -- 126,741 Comprehensive income (loss): Unrealized loss on marketable securities -- -- -- -- Net loss -- -- -- -- Comprehensive income (loss) -- -- -- -- ------------ ------------ ------------ ------------ Balance at December 31, 2001 $ 356 $ 290,016 $ -- $ 83,120,316 ============ ============ ============ ============ Deficit Total accumulated stockholders' Other during equity (net comprehensive development capital income(loss) stage deficiency) ------------- ------------ ------------ Balance at October 17, 1986 $ -- $ -- $ -- Common stock issued -- -- 42,124,138 Reincorporation in Delaware at $.01 par value -- -- -- Common stock subscribed -- -- (110,000) Common stock options and warrants issued -- -- 240,868 Issuance of common stock in connection with acquisition of Camelot Pharmacal, LLC -- -- 1,650,000 Common stock options extended -- -- 215,188 Accretion of issuance costs for Series A preferred stock -- (103,400) (103,400) Series C preferred stock issued -- -- 11,500,000 Series C preferred stock dividends -- (415,112) (1,112) Comprehensive income (loss): Unrealized loss on marketable securities (222,226) -- -- Net loss -- (54,638,251) -- Comprehensive income (loss) -- -- (54,860,477) ------------ ------------ ------------ Balance at December 31, 1998 (222,226) (55,156,763) 655,205 Common stock issued -- -- 101,563 Series C preferred stock dividends -- (868,277) (2,277) Series D preferred stock issued -- -- 12,015,000 Series F preferred stock issued -- -- 4,691,305 Common stock warrants issued -- -- 203,452 Comprehensive income (loss): Unrealized gain on marketable securities 391,613 -- -- Net loss -- (17,384,788) -- Comprehensive income (loss) -- -- (16,993,175) ------------ ------------ ------------ Balance at December 31, 1999 169,387 (73,409,828) 671,073 Common stock issued -- -- 3,811,810 Repurchase and retirement of common stock -- -- (313,189) Series C preferred stock dividends -- (934,045) (2,045) Series D preferred stock dividends -- (855,750) (750) Series E preferred stock issued -- -- 1,000,000 Series E preferred stock dividends -- (4,750) (750) Common stock warrants issued -- -- 195,202 Comprehensive income (loss): Unrealized loss on marketable securities (11,920) -- -- Net loss -- (5,763,151) -- Comprehensive income (loss) -- -- (5,775,071) ------------ ------------ ------------ Balance at December 31, 2000 157,467 (80,967,524) (413,720) Common stock issued -- -- 485,452 Repurchase and retirement of common stock -- -- (642,842) Series C preferred stock dividends -- (999,278) (3,278) Series D preferred stock dividends -- (929,603) (603) Series E preferred stock issued -- -- 1,000,000 Series E preferred stock dividends -- (121,422) (1,422) Common stock warrants issued -- -- 126,741 Comprehensive income (loss): Unrealized loss on marketable securities (157,467) -- -- Net loss -- (9,479,137) -- Comprehensive income (loss) -- -- (9,636,604) ------------ ------------ ------------ Balance at December 31, 2001 $ -- $(92,496,964) $ (9,086,276) ============ ============ ============
See notes to consolidated financial statements. -27- SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES (a development stage enterprise) CONSOLIDATED STATEMENTS OF CASH FLOWS For the Years Ended December 31, 2001, 2000 and 1999 and for the Period from October 17, 1986 (Inception) to December 31, 2001
October 17, 1986 Years ended December 31, (inception) to ------------------------ December 31, 2001 2000 1999 2001 ------------ ------------ ------------ ---------------- Cash flows from operating activities: Net loss $ (9,479,137) $ (5,763,151) $(17,384,788) $(87,265,326) Adjustments to reconcile net loss to net cash used by development stage activities: Issuance of common stock, stock options/warrants for services 126,741 207,202 203,452 2,819,368 Depreciation and amortization 130,554 118,775 86,341 728,890 Non-cash acquisition of research and development in-process technology -- -- -- 1,650,000 (Gain) loss realized on sale of marketable securities (79,706) (239,629) -- 5,580 Decrease (increase) in clinical supplies, prepaid expenses & other current assets 26,642 (395,035) (106,202) (572,671) Decrease (increase) in milestone advance receivable 1,000,000 (1,000,000) -- -- Increase in other assets (72,320) (64,089) (219,925) (297,292) Increase in accounts payable and accrued liabilities 352,646 615,636 154,418 1,154,148 (Decrease) increase in sponsored research payable -- (185,924) (28,124) 812,827 Other (72,343) 59,973 151,396 225,703 ------------ ------------ ------------ ------------ Net cash used by development stage activities (8,066,923) (6,646,242) (17,143,432) (80,738,773) ------------ ------------ ------------ ------------ Cash flows from investing activities: Proceeds from sale of marketable securities 249,661 419,674 -- 844,420 Acquisition of laboratory and office equipment, and leasehold improvements (200,570) (86,107) (136,588) (872,390) Other -- -- 10,000 (57,087) ------------ ------------ ------------ ------------ Net cash provided (used) by investing activities 49,091 333,567 (126,588) (85,057) ------------ ------------ ------------ ------------ Cash flows from financing activities: Payments on debt and capital leases (7,428) (6,435) (709,701) (850,036) Net proceeds from issuance of: Debt 5,000,000 1,000,000 2,600,000 12,050,000 Common stock -- 2,015,625 -- 23,433,660 Preferred stock 1,000,000 1,000,000 16,706,305 34,741,117 Proceeds from exercise of warrants/stock options 485,452 1,784,185 91,563 13,763,358 Repurchase and retirement of common stock (642,842) (313,189) -- (956,031) Other -- -- -- (500,024) ------------ ------------ ------------ ------------ Net cash provided by financing activities 5,835,182 5,480,186 18,688,167 81,682,044 Net (decrease) increase in cash and cash equivalents (2,182,650) (832,489) 1,418,147 858,214 Cash and cash equivalents at beginning of period 3,041,948 3,874,437 2,456,290 1,084 ------------ ------------ ------------ ------------ Cash and cash equivalents at end of period $ 859,298 $ 3,041,948 $ 3,874,437 $ 859,298 ============ ============ ============ ============ Noncash investing and financing activities: Common stock, stock options and warrants issued for services $ 126,741 $ 207,202 $ 203,452 $ 2,819,368 Common stock redeemed in payment of notes receivable -- -- -- 10,400 Acquisition of research and development in-process technology -- -- -- 1,655,216 Common stock issued for intellectual property rights -- -- -- 866,250 Common stock issued to retire debt -- -- -- 600,000 Common stock issued to redeem convertible securities -- -- -- 5,353,368 Securities acquired under sublicense agreement -- -- -- 850,000 Equipment acquired under capital lease -- -- -- 121,684 Notes payable converted to common stock -- -- -- 749,976 Stock dividends 2,050,305 1,794,545 868,277 5,491,674 Supplemental disclosure of cash information: Interest paid $ 7,060 $ 2,940 $ 8,919 $ 286,320
See notes to consolidated financial statements. -28- SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES (a development stage enterprise) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation - Sheffield Pharmaceuticals, Inc. ("Sheffield" or the "Company") a Delaware corporation, is focused on the development and commercialization of later stage pharmaceutical products that utilize the Company's unique proprietary pulmonary delivery technologies. The accompanying consolidated financial statements have been prepared on a going concern basis which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company is in the development stage and to date has been principally engaged in research, development and licensing efforts. The Company has generated minimal operating revenue, sustained significant net operating losses, and requires additional capital that the Company intends to obtain through out-licensing of rights to its technology, as well as through equity and debt offerings, to continue to operate its business. The Company's ability to meet its obligations as they become due and to continue as a going concern must be considered in light of the expenses, difficulties and delays frequently encountered in developing a new business, particularly since the Company will focus on product development that may require a lengthy period of time and substantial expenditures to complete. Even if the Company is able to successfully develop new products, there can be no assurance that the Company will generate sufficient revenues from the sale or licensing of such products to be profitable. Management believes that the Company's ability to meet its obligations as they become due and to continue as a going concern through December 2002 is dependent upon obtaining additional funding. In an effort to meet its capital requirement, the Company will be evaluating various financing alternatives including private offerings of its securities, debt financing, and collaboration and licensing arrangements with other companies. However, the accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty. Principles of Consolidation - The consolidated financial statements include the accounts of Sheffield and its wholly owned subsidiaries, Systemic Pulmonary Delivery, Ltd. ("SPD"), Ion Pharmaceuticals, Inc., and CP Pharmaceuticals, Inc., and its 80.1% owned subsidiary, Respiratory Steroid Delivery, Ltd. ("RSD"). All significant intercompany transactions have been eliminated. Investments in affiliated companies that are 50% owned or less, and where the Company does not exercise control, are accounted for using the equity method. Use of Estimates - The preparation of the financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Cash Equivalents - The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. Cash and cash equivalents include demand deposits held in banks, interest bearing money market funds, and corporate commercial paper with A1 or P1 short-term ratings. Marketable Securities - Marketable securities consist of investments that can be readily purchased or sold using established markets. The Company's securities, which are classified as available-for-sale, are carried at market with unrealized gains and losses reported as a separate component of other comprehensive income within stockholders' equity. Property and Equipment - Property and equipment are stated at cost. Depreciation is computed using the straight-line method over three or five year periods for office equipment, and five years for laboratory equipment. Assets under capital leases, consisting of office equipment and leasehold improvements, are amortized over the lesser of the useful life or the applicable lease terms. Patent Costs - Costs associated with obtaining patents, principally legal costs and filing fees, are capitalized and being amortized on a straight-line basis over the remaining lives of the respective patents. The Company periodically evaluates the carrying amount of these assets based on current licensing and future commercialization efforts, and if warranted, impairment would be recognized. Contract Research Revenue - Contract revenue from collaborative research agreements is recorded when earned and as the related costs are incurred. Payments received that are related to future performance are deferred and recognized as revenue in the period in which they are earned. Research and Development Costs - Research and development costs ("R & D costs") are expensed as incurred, except for fixed assets to which the Company has title, which are capitalized and depreciated over their estimated useful lives. -29- Income Taxes - The Company utilizes the liability method to account for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. Fair Value of Financial Instruments - The carrying amounts of cash and cash equivalents, receivables, accounts payable, sponsored research payable and notes payable approximate fair value. Basic Net Loss per Share of Common Stock - Basic net loss per share is calculated in accordance with Statement of Financial Accounting Standards ("SFAS") No. 128, Earnings Per Share. Basic net loss per share is based on net loss available to common stockholders divided by the weighted average common stock outstanding during the year. Potentially dilutive securities, such as stock options, warrants, convertible debt and preferred stock, have not been included in any years presented as their effect is antidilutive. The net loss available to common stockholders and basic and diluted net loss per share for the years ended December 31, 2000 and 1999 have been restated from amounts previously reported to properly reflect cumulative preferred stock dividends payable in kind. Such amounts may differ from dividends declared as reflected in the Statement of Stockholders' Equity. The effect of this restatement was to increase basic and diluted net loss per share from $.21 to $.27 and from $.64 to $.68 for the years ended December 31, 2000 and 1999, respectively. Stock-Based Compensation - SFAS No. 123, Accounting for Stock-Based Compensation, defines a fair value method of accounting for stock options and similar equity instruments. As permitted by SFAS 123, the Company continues to account for employee stock options under Accounting Principal Board Opinion No. 25, Accounting for Stock Issued to Employees ("APB 25"), and has disclosed in a note to the financial statements pro forma net loss and earnings per share as if the Company had applied the fair value method of accounting for its stock-based awards. Under APB 25, no expense is generally recognized at the time of option grant because the exercise price of the Company's employee stock option equals or exceeds the fair market value of the underlying common stock on the date of grant. Comprehensive Income (Loss) - SFAS No. 130, Reporting Comprehensive Income, establishes standards for the reporting and display of comprehensive income and its components in a full set of general purpose financial statements and applies to all enterprises. Other comprehensive income or loss shown in the consolidated statements of stockholders' equity at December 31, 2001, 2000 and 1999 is solely comprised of unrealized gains or losses on marketable securities. The unrealized loss on marketable securities during 2001 and 2000 includes reclassification adjustments of $79,706 and $239,629, respectively, for gains realized in income from the sale of the securities. Segment Information - SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information, establishes standards for the way that public business enterprises report information about operating segments in annual financial statements and requires that those enterprises report selected information about operating segments in interim financial reports. It also establishes standards for related disclosures about products and services, geographic areas and major customers. The Company operates in one reportable segment as defined by SFAS No. 131. Reclassifications - Certain amounts in the prior year financial statements and notes have been reclassified to conform to the current year presentation. 2. LEASES The Company leases its office space and certain equipment under noncancelable operating and capital leases that expire at various dates through 2003. At December 31, 2001, assets held under capital leases consisting of office equipment were $11,397, net of accumulated amortization of $37,834. Future minimum lease payments under capital and operating leases at December 31, 2001 are as follows:
Capital Operating Leases Leases -------- -------- 2002 .................................................... $ 9,375 $168,478 2003 .................................................... 774 2,463 -------- -------- Total minimum lease payments ............................ 10,149 $170,941 ======== Less amount representing interest ....................... (806) -------- Present value of net minimum lease payments ............. 9,343 Less current maturities of capital lease obligations .... (8,578) -------- Capital lease obligations ............................... $ 765 ========
-30- Rent expense relating to operating leases for the years ended December 31, 2001, 2000 and 1999 was $226,759, $219,859, and $174,332, respectively. 3. STOCKHOLDERS' EQUITY Preferred Stock In June 1998, the Company issued 4,571,428 shares of Common Stock and 11,500 shares of Series C Cumulative Convertible Preferred Stock ("Series C Preferred Stock"), convertible into shares of Common Stock of the Company or of its wholly owned subsidiary, SPD, for $17.5 million pursuant to a definitive agreement with an affiliate of Elan Corporation, plc ("Elan"), Elan International Services, Ltd. ("Elan International"). The Series C Preferred Stock earns cumulative dividends payable in shares of Series C Preferred Stock at an annual rate of 7.0% on the stated value of each outstanding share of Series C Preferred Stock on the dividend date. Elan International also received a warrant to purchase 990,000 shares of Common Stock of the Company exercisable from December 31, 1998 through January 30, 2005 at an exercise price of $2.00 per share. Under the terms of the agreement, the Company, through SPD, acquired certain pulmonary delivery technologies for the sum of $12.5 million in cash (see Note 6). All of the outstanding Common Stock of SPD is pledged to Elan during the term of the agreement. Subject to certain conditions and the making of certain payments to the Company, Elan International has the option to acquire all or a portion of the outstanding stock of SPD. The net book value of SPD is $.1 million as of December 31, 2001. The Company issued stock dividends totaling 996 and 932 shares of Series C Preferred Stock and cash dividends for fractional shares of $3,278 and $2,045 for the years ended December 31, 2001 and 2000, respectively. In October 1999, pursuant to a definitive agreement, the Company and Elan International formed RSD to develop certain respiratory steroid products. Under the terms of the agreement, the Company issued to Elan International 12,015 shares of Series D Cumulative Convertible Exchangeable Preferred Stock ("Series D Preferred Stock"), convertible into shares of Common Stock of the Company at $4.86 per Common Share or exchangeable for an additional 30.1% ownership interest in the new joint venture, for $12.0 million. The Series D Preferred Stock earns cumulative dividends payable in shares of Series D Preferred Stock at an annual rate of 7.0% on the stated value of each outstanding share of Series D Preferred Stock on the dividend date. The Company issued stock dividends totaling 929 and 855 shares of Series D Preferred Stock and cash dividends for fractional shares of $603 and $750 for the years ended December 31, 2001 and 2000, respectively. Elan International also has committed to purchase, on a drawdown basis, up to $4.0 million of the Company's Series E Cumulative Convertible Preferred Stock ("Series E Preferred Stock"), convertible into shares of Common Stock of the Company at $3.89 per Common Share. During 2001 and 2000, Elan International purchased a total of $2.0 million of the Series E Preferred Stock. The Series E Preferred Stock will be utilized by the Company to fund its portion of RSD's operating and development costs. The Series E Preferred Stock earns cumulative dividends payable in shares of Series E Preferred Stock at an annual rate of 9.0% on the stated value of each outstanding share of Series E Preferred Stock on the dividend date. The Company issued stock dividends totaling 120 and 4 shares of Series E Preferred Stock and cash dividends for fractional shares of $1,422 and $750 for the years ended December 31, 2001 and 2000, respectively. In addition to the above, the Company issued to Elan International 5,000 shares of Series F Convertible Non-Exchangeable Preferred Stock ("Series F Preferred Stock"), convertible into shares of Common Stock of the Company at $3.40 per Common Share, for $5.0 million. The proceeds of the Series F Preferred Stock were utilized by Sheffield for its own operating purposes. The holders of the Series F Preferred Stock may be entitled to receive dividends on a pari passu basis with the holders of Common Stock. As part of the transaction, Elan International also received a warrant to purchase 150,000 shares of Common Stock of the Company at an exercise price of $6.00 per share (see Note 6). Common Stock During 1998, the Company entered into an agreement with Zambon Group, SpA ("Zambon") for a sublicense to the Company's proprietary Premaire(R) Delivery System ("Premaire"), a portable nebulizer-based pulmonary delivery system (see Note 6). Pursuant to an option agreement dated April 15, 1998, the Company issued 800,000 shares of Common Stock to Zambon for $650,000 in cash. On June 15, 1998, the Company entered into the definitive agreement, resulting in the issuance of an additional 1,846,153 shares of Common Stock to Zambon for $1.5 million. On October 17, 2001, as part of the September 28, 2001 amendment of the Company's 1998 agreement with Zambon, the Company repurchased from Zambon, 214,997 shares of common stock for $3.0233 per share ("Repurchase Price"). In addition, the Company received an option, expiring December 31, 2002, to repurchase the remaining shares of the Company's common stock held by Zambon at the Repurchase Price. In the event the Company completes a sublicense for the North American rights or a sublicense for the non- North American rights to the Premaire respiratory products prior to December 31, 2002, the Company will be required to repurchase from Zambon 882,051 shares of the Company's common stock on each of the events. In December 2000, the Company entered into a stock purchase agreement with The Tail Wind Fund Ltd. ("Tail Wind"). Under the agreement, Sheffield issued and sold 626,950 shares of Common Stock and a warrant to purchase 112,500 shares of Common Stock at an exercise price of $4.9844 per share for total cash consideration of $2.3 million. The net proceeds from the transaction of $2.0 million -31- were available to be used for general corporate purposes. Pursuant to the stock purchase agreement, until at least August 29, 2002, if Sheffield sells shares of Common Stock or securities convertible into or exercisable for Common Stock for less than $3.5888 per share, Sheffield is obligated to issue to Tail Wind additional shares so that the number of shares purchased by Tail Wind in the December 2000 private placement plus the additional shares issued to Tail Wind equals the number of shares that Tail Wind could have purchased for $2.3 million at the price per share at which the new shares are sold. In addition, in the event that the Company is required to issue additional shares to Tail Wind, Sheffield may not issue an aggregate of over 5,630,122 shares of Common Stock in total to Tail Wind in connection with the December 2000 private placement. If the Company would otherwise be required to issue more than 5,630,122 shares to Tail Wind, Sheffield must instead pay Tail Wind 105% of the cash value of such shares the Company does not issue. 4. STOCK OPTIONS AND WARRANTS Stock Option Plan - The 1993 Stock Option Plan (the "Option Plan") was adopted by the Board of Directors in August 1992 and approved by the stockholders at the annual meeting in December 1993. An amendment to the Option Plan increasing the number of shares of Common Stock available for issuance thereunder from 3 million shares to 4 million shares received stockholder approval on July 15, 1998. The Option Plan permits the grant to employees and officers of the Company of both incentive stock options and non-statutory stock options. The Option Plan is administered by the Board of Directors or a committee of the Board, which determines the persons to whom options will be granted and the terms thereof, including the exercise price, the number of shares subject to each option, and the exercisability of each option. The exercise price of all options for Common Stock granted under the Option Plan must be at least equal to the fair market value on the date of grant in the case of incentive stock options, and 85% of the fair market value on the date of grant in the case of non-statutory stock options. Options generally expire five to ten years from the date of grant and vest either over time or upon the Company's Common Stock attaining a set market price for a certain number of trading days. Certain employment agreements provide for an immediate vesting of all unvested options held by the employee upon a change of control of the Company. Upon such a change of control, recognition of compensation expense may be triggered, the amount of which cannot be determined at this time. As of December 31, 2001, there are 709,700 shares available for grant under the Option Plan. Restricted Stock Plan - The 1993 Restricted Stock Plan (the "Restricted Plan") was adopted by the Board of Directors in August 1992 and approved by the stockholders at the annual meeting in December 1993. The Restricted Plan authorized the grant of a maximum of 150,000 shares of Common Stock to key employees, consultants, researchers and members of the Company's Scientific Advisory Board. The Restricted Plan is administered by the Board of Directors or a committee of the Board, which determines the person to whom shares will be granted and the terms of such share grants. As of December 31, 2001, no shares have been granted under the Restricted Plan. Directors Stock Option Plan - The 1996 Directors Stock Option Plan (the "Directors Plan") was adopted by the Board of Directors and approved by the stockholders on June 20, 1996. Under the Directors Plan, the maximum aggregate number of shares that may be optioned and sold is 500,000 shares of Common Stock. The Directors Plan initially granted each eligible director 15,000 stock options. To the extent that shares remain available, any new directors shall receive the grant of an option to purchase 25,000 shares. To the extent that shares remain available under the Directors Plan, on January 1 of each year commencing January 1, 1997, each eligible director shall be granted an option to purchase 15,000 shares. The exercise price of all options granted under the Directors Plan shall be the fair market value at the date of the grant. Options generally expire five years from the date of grant. As of December 31, 2001, there are 170,000 shares available for grant under the Directors Plan. SFAS No. 123 requires pro forma information regarding net income and earnings per share as if the Company has accounted for its stock options granted subsequent to December 31, 1994, under the fair value method of SFAS No. 123. The fair value of these stock options is estimated at the date of grant using a Black-Scholes option pricing model with the following weighted average assumptions for 2001, 2000, and 1999, risk-free interest rate ranging from 4.39% to 6.36%; expected volatility ranging from 0.628 to 0.874; expected option life of one to ten years from vesting and an expected dividend yield of 0.0%. For purposes of pro forma disclosures, the estimated fair value of the stock options is amortized to expense over the options' vesting period. The Company's pro forma information is as follows:
2001 2000 1999 -------------- -------------- -------------- Pro forma net loss .......................... $ (12,479,299) $ (10,036,410) $ (18,843,611) Pro forma basic net loss per share of common stock .............................. $ (.43) $ (.36) $ (.69)
As discussed in Note 1, the net loss available to common stockholders and basic and diluted net loss per share for the years ended December 31, 2000 and 1999 have been restated to properly reflect cumulative preferred stock dividends payable in kind. As a result, the 2000 and 1999 pro forma basic net loss per share of common stock above have also been restated. -32- Transactions involving stock options and warrants are summarized as follows:
Years Ended December 31, --------------------------------------------------------------------------------------------- 2001 2000 1999 ---------------------------- --------------------------- ----------------------------- Weighted Weighted Weighted Average Average Average Common Stock Exercise Common Stock Exercise Common Stock Exercise Options/Warrants Price Options/Warrants Price Options/Warrants Price ---------------- -------- ---------------- -------- ---------------- -------- Outstanding, January 1 6,921,629 $ 3.02 7,782,954 $ 2.59 7,910,836 $ 2.55 Granted 156,940 4.44 1,041,040 5.34 555,040 2.97 Expired 250,000 2.99 660,820 2.90 315,422 3.92 Exercised 558,100 1.73 1,241,545 2.32 367,500 1.07 Canceled 85,000 3.21 -- -- -- -- --------- -------- --------- -------- --------- -------- Outstanding, December 31 6,185,469 $ 3.18 6,921,629 $ 3.02 7,782,954 $ 2.59 ========= ======== ========= ======== ========= ======== Exercisable at end of year 4,525,969 $ 2.77 5,049,613 $ 2.57 6,358,554 $ 2.51 ========= ======== ========= ======== ========= ========
During the period January 1, 1999 through December 31, 2001, the exercise prices and weighted average fair value of options and warrants granted by the Company were as follows:
Year Number of Options/Warrants Exercise Price Weighted Average Fair Value ---- -------------------------- -------------- --------------------------- 1999 555,040 $0.82 - 6.00 $ 1.34 2000 1,041,040 $3.50 - 7.00 $ 3.37 2001 156,940 $3.58 - 5.25 $ 3.03
At December 31, 2001, outstanding warrants to purchase the Company's Common Stock are summarized as follows:
Range of Weighted Average Remaining Exercise Prices Outstanding Warrants Contractual Life (Years) Weighted Average Exercise Price - --------------- -------------------- ------------------------ ------------------------------- $1.38 - $2.00 1,054,910 3.37 $ 1.97 $2.50 - $3.65 521,179 0.30 $ 3.30 $4.00 - $6.13 384,080 4.04 $ 5.46 --------- Total 1,960,169 2.68 $ 3.01 =========
At December 31, 2001, outstanding options to purchase the Company's Common Stock are summarized as follows:
Range of Weighted Average Remaining Exercise Prices Outstanding Options Contractual Life (Years) Weighted Average Exercise Price - --------------- ------------------- ------------------------ ------------------------------- $1.24 - $2.69 1,036,000 3.82 $ 1.74 $2.75 - $3.25 1,681,000 4.67 $ 2.80 $3.50 - $7.00 1,508,300 5.24 $ 4.79 --------- Total 4,225,300 4.66 $ 3.25 =========
5. NOTES PAYABLE AND LONG-TERM DEBT Note Payable In August 2001, the Company entered into a Note Purchase Agreement ("Note") with Elan Pharma International Ltd. ("Elan Pharma"), pursuant to which Elan Pharma agreed to lend the Company up to $4 million. All borrowings under the Note are evidenced by an unsecured promissory note of the Company providing for interest on principal and semi-annually compounded at a fixed rate of 10% per annum and a maturity of November 14, 2002, or upon the earlier occurrence of one or more specified events. The outstanding principal balance of the Note was $4.0 million at December 31, 2001. Convertible Promissory Note As part of the 1998 agreement with Elan, Elan agreed to make available to the Company a Convertible Promissory Note ("Convertible Note") that provides the Company the right to borrow up to $2.0 million, subject to satisfying certain conditions. No more than $500,000 may be drawn under the Convertible Note in any calendar quarter and at least one-half of the proceeds must be used to fund SPD's development activities. The principal outstanding under the Convertible Note bears interest at the prime rate plus 1% and, if not previously converted, matures on June 30, 2005. Prior to repayment, Elan has the right to convert all principal and accrued interest into shares of the Company's Common Stock at a conversion price of $1.75 per share. The outstanding principal balance of the Convertible -33- Note at December 31, 2001 and 2000 was $2.0 million, and accrued interest was $.6 million and $.4 million at December 31, 2001 and 2000, respectively. Long-Term Debt In September 2001, in connection with the amendment of its 1998 agreement with Zambon, the Company entered into a Loan and Security Agreement (the "Loan") with Zambon, pursuant to which Zambon agreed to lend the Company $2.5 million. The Company received $1.0 million upon signing of the Loan, with additional borrowings of $1.0 million and $.5 million to be made on January 1, 2002 and April 1, 2002, respectively. The Loan provides for interest on principal and annually compounded interest at a fixed rate of 2% per annum and is secured by certain security interests in respiratory products developed in the Premaire. One third of the principal balance, together with interest, is payable by the Company upon the Company's execution of an agreement with one or more third parties to develop, co-promote and/or sell certain products in North America, with all remaining unpaid principal and interest due on December 31, 2005. The outstanding principal balance of the Loan was $1.0 million at December 31, 2001. On January 1, 2002, the Company received the additional borrowing of $1.0 million as provided by the Loan. In conjunction with the completion of the Phase I/II Premaire albuterol trial in 1999 and the demonstration of the technical feasibility of delivering an inhaled steroid formulation in the Premaire in 2000, Zambon provided the Company with two $1.0 million interest-free advances against future milestone payments. The second advance was received in January 2001 and was reflected in the accompanying financial statements as a milestone advance receivable at December 31, 2000. The proceeds from these advances were not restricted as to their use by the Company (see Note 6). As part of the amendment of its 1998 agreement with Zambon, the terms of all milestone advances received from Zambon were modified in that the Company shall repay $1.0 million of the advance milestone payments upon the earlier of December 31, 2003, or upon the first regulatory approval for either albuterol or an inhaled steroid delivered in the Premaire. The remaining $1.0 million advance shall be repaid by the Company on the earlier of December 31, 2005, or the regulatory approval of the second product (albuterol or an inhaled steroid) delivered in the Premaire. Due to the modification in the repayment terms, the advances, totaling $2.0 million at both December 31, 2001 and 2000, have been reclassified in the Company's balance sheet as long-term debt. 6. RESEARCH AND DEVELOPMENT AGREEMENTS Pulmonary Delivery Technologies In June 1998, the Company sublicensed to Zambon worldwide marketing and development rights to respiratory products to be delivered by the Premaire in return for an equity investment in the Company (approximately 10%). From June 1998 to September 2001, Zambon funded the development costs for the respiratory compounds delivered by Premaire. In September 2001, the Company amended its 1998 agreement with Zambon whereby Sheffield regained the rights to the Premaire previously granted to Zambon. Upon commercialization, Zambon will be entitled to certain royalties on payments received by Sheffield for albuterol, ipratropium and cromolyn sales for specified periods. In June 1998, the Company issued certain equity securities pursuant to an agreement with Elan (see Note 3). Under the terms of the agreement, the Company, through its wholly owned subsidiary, SPD, acquired certain pulmonary delivery technologies from Elan for $12.5 million in cash. In July 1998, SPD acquired from Aeroquip-Vickers, Inc. a new generation propellant-based pulmonary delivery system called the Tempo(TM) Inhaler for $.9 million. The payments for these technologies were expensed during 1998 as acquired R&D in-process technology since the technologies acquired had not demonstrated technological feasibility and had no alternative future uses. SPD holds the rights to all systemic disease applications of the Tempo technology while Sheffield retains the rights to develop the respiratory disease applications of Tempo. The Company is responsible for the development of these technologies. Pursuant to its agreement with Elan, at December 31, 2001, the Company was not committed to fund any additional costs related to SPD's systemic development programs. In October 1999, the Company issued certain equity securities pursuant to an agreement with Elan (see Note 3). Under the terms of the agreement, the Company, through its majority owned subsidiary RSD, licensed certain pulmonary NanoCrystal(TM) technology from Elan for $15.0 million in cash. This payment was expensed as acquired R&D in-process technology as the license agreement restricts the Company's use of the NanoCrystal technology to certain respiratory steroid products that are currently research and development. The subsidiary is responsible for the development of certain respiratory steroid products. Pursuant to its agreement with Elan, at December 31, 2001, the Company was committed to fund $2.0 million to the subsidiary for the development of these products, which the Company will fund by the issuance of its Series E Preferred Stock. -34- Early Stage Technologies The Company also is party to a number of license and research agreements, primarily with universities, hospitals, and research facilities, relating to early stage medical research projects that focus on the development of new compounds for the treatment of cancer, acquired immune deficiency syndrome and other diseases. As part of the Company's focus on later stage opportunities, the Company is seeking to out-license these projects. There can be no assurance that the Company will receive license fees or other payments related to these technologies. The Company believes these early stage technology license and research agreements will have no material impact on the financial position of the Company. On November 20, 1997, the Company entered into a sublicense agreement with Lorus Therapeutics, Inc. (formerly Imutec Pharma Inc.) ("Lorus"). The agreement licenses rights to a series of clotrimazole-related compounds for the treatment of cancer, Kaposi's sarcoma and actinic keratosis to a newly formed company, NuChem Pharmaceuticals, Inc. ("NuChem"). In exchange, Lorus agreed to manage and fund the remaining development program. The Company is entitled to receive payments upon the completion of certain milestones in the development of these compounds and retains a 20% ownership interest in NuChem. 7. INCOME TAXES At December 31, 2001, the Company had available net operating loss carryforwards for regular federal income tax purposes of approximately $50.9 million, of which $27.5 million will expire between 2007 and 2012, and $23.4 million will expire between 2018 and 2021, if not utilized. Utilization of the Company's net operating loss carryforwards may be subject to an annual limitation as a result of the "changes in ownership" provisions of the Internal Revenue Code Section 382. Future changes in ownership may limit net operating loss carryforwards generated in the year of change. Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's net deferred tax asset at December 31, 2001 and 2000, which are considered noncurrent, are as follows:
DEFERRED TAX ASSETS 2001 2000 ------------ ------------ Net operating loss carryforwards ............ $ 19,348,000 $ 16,289,000 Costs capitalized for tax purposes .......... 1,810,000 1,975,000 Deferred tax asset valuation allowance ...... (21,158,000) (18,264,000) ------------ ------------ Net deferred tax asset ................... $ -- $ -- ============ ============
The Company has recorded a valuation allowance for the entire deferred tax asset due to the uncertainty of its realization. The deferred tax asset will be amortized into taxable income over a useful life of 15 years. -35- ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA (CONTINUED) Quarterly financial data for 2001 and 2000 is summarized below:
Three Months Ended ------------------ Mar 31 Jun 30 Sep 30 Dec 31 ----------- ----------- --------- --------- 2001: Total revenues $ 180,747 $ 693,348 $ -- $ -- Operating loss (1,623,295) (2,360,545) (2,717,608) (2,975,811) Net loss (1,580,410) (2,279,410) (2,592,821) (3,026,496) Basic and diluted net loss per common share (.07) (.10) (.11) (.12) 2000: Total revenues $ 121,170 $ 124,505 $ 46,109 $ 214,788 Operating loss (1,475,577) (1,449,671) (1,367,362) (1,765,790) Net loss (1,457,090) (1,383,810) (1,318,141) (1,604,110) Basic and diluted net loss per common share (.07) (.07) (.06) (.07)
Basic net loss per share is based on net loss available to common stockholders divided by the weighted average common stock outstanding during the quarter. The net loss available to common stockholders and basic and diluted net loss per share for the quarters ended September 30, 2001, June 30, 2001, and March 31, 2001, and for each of the quarters in 2000 have been restated from amounts previously reported to properly reflect cumulative preferred stock dividends payable in kind as discussed in Note 1 to the financial statements. The effect of this restatement was to increase basic and diluted net loss per share from $.09 to $.11, from $.08 to $.10 and from $.05 to $.07 for the quarters ended September 30, 2001, June 30, 2001, and March 31, 2001, respectively, and from $.06 to $.07, from $.05 to $.06, from $.05 to $.07, and from $.05 to $.07 for the quarters ended December 31, 2000, September 30, 2000, June 30, 2000, and March 31, 2000, respectively. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT The information required by this Item is incorporated by reference to the Company's definitive proxy statement to be filed no later than April 30, 2002, pursuant to Regulation 14A of the General Rules and Regulations under the Securities Exchange Act of 1934. ITEM 11. EXECUTIVE COMPENSATION The information required by this Item is incorporated by reference to the Company's definitive proxy statement to be filed no later than April 30, 2002, pursuant to Regulation 14A of the General Rules and Regulations under the Securities Exchange Act of 1934. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this Item is incorporated by reference to the Company's definitive proxy statement to be filed no later than April 30, 2002, pursuant to Regulation 14A of the General Rules and Regulations under the Securities Exchange Act of 1934. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this Item is incorporated by reference to the Company's definitive proxy statement to be filed no later than April 30, 2002, pursuant to Regulation 14A of the General Rules and Regulations under the Securities Exchange Act of 1934. -36- ITEM14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a)(1) Financial Statements The following Financial Statements are included in Item 8 hereto: Report of Independent Auditors Consolidated Balance Sheets as of December 31, 2001 and 2000 Consolidated Statements of Operations for the years ended December 31, 2001, 2000 and 1999 and for the period October 17, 1986 (inception) to December, 31 2001 Consolidated Statements of Stockholders' Equity (net capital deficiency) for the period from October 17, 1986 (inception) to December 31, 2001 Consolidated Statements of Cash Flows for the years ended December 31, 2001, 2000 and 1999 and for the period from October 17, 1986 (inception) to December 31, 2001 Notes to Financial Statements (a)(2) Financial Statement Schedules All financial statement schedules are omitted because they are not applicable, or not required, or because the required information is included in the financial statements or notes thereto. (a)(3) Exhibits:
NO. REFERENCE 3.1 Certificate of Incorporation of the Company, as amended (9) 3.2 By-Laws of the Company (4) 4.1 Form of Common Stock Certificate (2) 4.4 Certificate of Designations defining the powers, (9) designations, rights, preferences, limitations and restrictions applicable to the Company's Series C Cumulative Convertible Redeemable Preferred Stock. 4.5 Certificate of Designations defining the powers, (14) designations, rights, preferences, limitations and restrictions applicable to the Company's Series D Cumulative Convertible Exchangeable Preferred Stock. 4.6 Certificate of Designations defining the powers, (14) designations, rights, preferences, limitations and restrictions applicable to the Company's Series E Convertible Non-Exchangeable Preferred Stock. 4.7 Certificate of Designations defining the powers, (14) designations, rights, preferences, limitations and restrictions applicable to the Company's Series F Convertible Non-Exchangeable Preferred Stock. 10.6 Employment Agreement dated as of June 6, 1996 between the (3) Company and Thomas M. Fitzgerald* 10.6A Amendment dated October 1, 2002 to Employment Agreement (1) between the Company and Thomas M. Fitzgerald.*
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NO. REFERENCE 10.6.5 Employment Agreement dated as of November 16, 1998 between (13) the Company and Scott Hoffmann* 10.6.5A Amendment dated October 1, 2001 to Employment Agreement (1) between the Company and Scott Hoffmann.* 10.6.6 Employment Agreement dated as of August 3, 1998 between the (1) Company and Thomas A. Armer* 10.6.6A Amendment dated October 1, 2001 to Employment Agreement (1) between the Company and Thomas A. Armer.* 10.8 1993 Stock Option Plan, as amended* (17) 10.9 1993 Restricted Stock Plan, as amended* (17) 10.10 1996 Directors Stock Option Plan* (6) 10.11 Agreement and Plan of Merger among the Company, Camelot (5) Pharmacal, L.L.C., David A. Byron, Loren G. Peterson and Carl Siekmann dated April 25, 1997* 10.12 Employment Agreement dated as of April 25, 1997 between the (5) Company and David A. Byron* 10.13 Employment Agreement dated as of April 25, 1997 between the (5) Company and Loren G. Peterson, as amended* 10.13A Amendment dated October 1, 2001 to Employment Agreement (1) between the Company and Loren G. Peterson.* 10.14 Employment Agreement dated as of April 25, 1997 between the (5) Company and Carl Siekmann* 10.19 Form of Sublicense and Development Agreement between (11) Sheffield Pharmaceuticals, Inc. and Inpharzam International, S.A. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.20 Securities Purchase Agreement, dated as of June 30, 1998, (12) by and between Sheffield Pharmaceuticals, Inc. and Elan International Services, Ltd., which includes the Certificate of Designations of Series C Convertible Preferred Stock as Exhibit B. The Company agreed to furnish the disclosure schedules as well as Exhibits A and C, which were omitted from this filing, to the Commission upon request (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.21 Systemic Pulmonary Delivery, Ltd. Joint Development and (12) Operating Agreement dated as of June 30, 1998 among Systemic Pulmonary Delivery, Ltd., Sheffield Pharmaceuticals,
38
NO. REFERENCE Inc. and Elan International Services, Ltd. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.22 License and Development Agreement dated June 30, 1998 (12) between Sheffield Pharmaceuticals, Inc. and Systemic Pulmonary Delivery, Ltd. and Elan Corporation plc. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.23 License and Development Agreement dated June 30, 1998 (12) between Systemic Pulmonary Delivery, Ltd. and Sheffield Pharmaceuticals, Inc. and Elan Corporation, plc. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.24 License and Development Agreement dated June 30, 1998 (12) between Elan Corporation, plc and Systemic Pulmonary Delivery, Ltd. and Sheffield Pharmaceuticals, Inc. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.25 Securities Purchase Agreement, dated as of October 18, (14) 1999, by and between the Company and Elan (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.26 Subscription, Joint Development and Operating Agreement (14) dated as of October 18, 1999 by and among Elan Pharma International Limited, Elan, the Company and Respiratory Steroid Delivery, Ltd. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.27 License Agreement, dated as of October 19, 1999, by and (14) between the Company and Respiratory Steroid Delivery, Ltd. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended).
39
NO. REFERENCE 10.28 License Agreement, dated as of October 19, 1999, by and (14) between Elan Pharma International Limited and Respiratory Steroid Delivery, Ltd. (portions of this exhibit were omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.29 Registration Rights Agreement dated as of October 18, 1999 (14) by and between Elan and the Company. 10.30 Securities Purchase Agreement dated as of December 29, (15) 2000, by and between the Company and The Tail Wind Fund Ltd 10.31 Registration Rights Agreement dated as of December 29, (15) 2000, by and between the Company and The Tail Wind Fund Ltd 10.32 Amendment to Sublicense and Development Agreement dated (16) September 29, 2001, between Sheffield Pharmaceuticals, Inc. and Inpharzam International S.A. 10.33 Loan and Security Agreement dated September 29, 2001, (16) between Sheffield Pharmaceuticals, Inc. and Inpharzam International, S.A. 10.34 Promissory Note dated September 29, 2001 issued to (16) Inpharzam International, S.A. 10.35 Note Purchase Agreement dated August 14, 2001 between (16) Sheffield Pharmaceuticals, Inc. and Elan Pharma International Ltd. (portions of this exhibit are omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.36 Promissory Note dated September 29, 2001 issued to Elan (16) Pharma International Ltd. (portions of this exhibit are omitted and were filed separately with the Securities and Exchange Commission pursuant to the Company's application requesting confidential treatment in accordance with Rule 24b-2 as promulgated under the Securities Exchange Act of 1934, as amended). 10.37 Separation Agreement dated as of February 18, 2002 between (1) the Company and Carl Siekmann* 10.38 Separation Agreement dated as of February 18, 2002 between (1) the Company and David A. Byron* 10.39 Indemnification Agreement dated January 23, 2002 between the Company and certain officers and directors. (1) 21 Subsidiaries of Registrant (1) 23.1 Consent of Ernst & Young LLP (1) 24 Power of Attorney (Included on page 42 hereof) (1)
40 * Management contracts or compensatory plans or arrangements. - ----------------------- (1) Filed herewith. (2) Incorporated by reference to the Company's Annual Report on Form 10-KSB for its fiscal year ended December 31, 1995 filed with the Securities and Exchange Commission. (3) Incorporated by reference to the Company's Quarterly Report on Form 10-QSB for the quarter ended June 30, 1996 filed with the Securities and Exchange Commission. (4) Incorporated by reference to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 1997 filed with the Securities and Exchange Commission. (5) Incorporated by reference to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 1997 filed with the Securities and Exchange Commission. (6) Incorporated by reference to the Company's Annual Report on Form 10-KSB for the year ended December 31, 1996 filed with the Securities and Exchange Commission. (7) Incorporated by reference to the Company's Registration Statement on Form S-3 (File No. 333-38327) filed with the Securities and Exchange Commission on October 21, 1997. (8) Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on December 17, 1997. (9) Incorporated by reference to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 1998 filed with the Securities and Exchange Commission. (10) Incorporated by reference to Exhibit 3 of the Company's Current Report on Form 8-K, dated April 17, 1998, filed with the Securities and Exchange Commission. (11) Incorporated by reference to Exhibit 2 of the Company's Current Report on Form 8-K, dated June 22, 1998, filed with the Securities and Exchange Commission. (12) Incorporated by reference to exhibits to the Company's Current Report on Form 8-K, dated July 16, 1998, filed with the Securities and Exchange Commission. (13) Incorporated by reference to the Company's Annual Report on Form 10-K for the year ended December 31, 1998 filed with the Securities and Exchange Commission. (14) Incorporated by reference to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on November 2, 1999. (15) Incorporated by reference to the Company's Registration Statement on Form S-3 (File No. 333-54446) filed with the Securities and Exchange Commission on January 26, 2001. (16) Incorporated by reference to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2001 filed with the Securities and Exchange Commission. (17) Incorporated by reference to the Company's Annual Report on Form 10-K for the year ended December 31, 2000 filed with the Securities and Exchange Commission. (b) Reports on Form 8-K (1) Current Report on Form 8-K filed with Securities and Exchange Commission on October 11, 2001 to announce the filing of a press release under Item 5, and Current Report on Form 8-K filed with the Securities and Exchange Commission on December 21, 2001 to announce under Item 5 the filing of exhibits. 41 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. SHEFFIELD PHARMACEUTICALS, INC. Dated: March 28, 2002 /s/ Loren G. Peterson ----------------------------------------- Loren G. Peterson President and Chief Executive Officer POWER OF ATTORNEY Sheffield Pharmaceuticals, Inc. and each of the undersigned do hereby appoint Loren G. Peterson and Thomas Fitzgerald and each of them severally, its or his or her true and lawful attorney to execute on behalf of Sheffield Pharmaceuticals, Inc. and the undersigned any and all amendments to this Annual Report and to file the same with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission; each of such attorneys shall have the power to act hereunder with or without the other. Pursuant to the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
SIGNATURE TITLE DATE --------- ----- ---- /s/ Thomas M. Fitzgerald Chairman and Director March 28, 2002 - ------------------------------------------------------ Thomas M. Fitzgerald /s/ Loren G. Peterson Director, President and Chief March 28, 2002 - ------------------------------------------------------ Executive Officer (Principal Executive Officer) Loren G. Peterson /s/ John M. Bailey Director March 28, 2002 - ------------------------------------------------------ John M. Bailey /s/ Digby W. Barrios Director March 28, 2002 - ------------------------------------------------------ Digby W. Barrios /s/ Todd C. Davis Director March 28, 2002 - ------------------------------------------------------ Todd C. Davis /s/ Scott A. Hoffmann Vice President, Finance and Administration, March 28, 2002 - ------------------------------------------------------ Treasurer and Secretary (Principal Financial and Scott A. Hoffmann Principal Accounting Officer)
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EX-10.6A 3 c68433ex10-6a.txt AMENDMENT TO EMPLOYMENT AGREEMENT EXHIBIT 10.6A THIS FIRST AMENDMENT TO EMPLOYMENT AGREEMENT ("First Amendment") is made this first day of October, 2001 (the "Effective Date"), by and between Sheffield Pharmaceuticals, Inc. (the "Corporation") and Thomas M. Fitzgerald (the "Executive"). WHEREAS, the Compensation Committee of the Board of Directors has determined that a possibility of a Change in Control of the Corporation exists and appropriate steps should be taken to reinforce and encourage the continued attention and dedication of certain management to their assigned duties. NOW, THEREFORE, in consideration of the covenants and agreements contained herein, intending to be legally bound, the Corporation and Executive hereby agree, effective as of the Effective Date, as follows: 1. Paragraph 3 of the Employment Agreement by and between the Corporation and Executive dated June 6, 1996 (the "Employment Agreement") is hereby amended by deleting the third sentence in its entirety and adding to the second sentence the following: "; provided that, no such notice by the Corporation shall be effective and the term of this Agreement shall be extended for an additional year if a Potential Change in Control shall have occurred or occurs at any time prior to the date of such notice or within the twelve month period beginning on the date of such notice. Further, if a Change in Control shall have occurred at any time during the term of this Agreement, then notwithstanding any provision hereof to the contrary, the term shall continue in effect for: (i) the remainder of the month in which the Change in Control occurred, and (ii) a term of twenty-four months beyond the month in which such Change in Control occurred; provided that, if any obligations of the Corporation hereunder shall not have been fully and finally discharged at the end of such twenty-four month period, the term shall continue until such obligations shall have been finally discharged in full. The period commencing on the earlier of a Potential Change in Control (if applicable) or Change in Control and ending with the conclusion of such twenty-four month period shall be referred to hereinafter as the "Protection Period." 2. Paragraph 11(c) of the Employment Agreement is hereby deleted in its entirety. 3. Paragraph 13 of the Employment Agreement is hereby amended by deleting Paragraph 13 in its entirety and replacing it with the following: "13. Termination for Cause. The Corporation may at any time upon written notice to Executive terminate Executive's employment for Cause. For purposes of this Agreement, the following shall constitute Cause: (a) the Executive's gross misconduct which is materially and demonstrably injurious to the Corporation; (b) the Executive's willful and continued failure to perform substantially his duties with the Corporation (other than a failure resulting from the Executive's incapacity due to bodily injury or physical or mental illness) after a demand for substantial performance is delivered to the Executive by the Board which specifically identifies the manner in which the Board believes that the Executive has not substantially performed his duties and provides for a reasonable period of time within which the Executive may take corrective measures; or (c) the Executive's conviction (including a plea of nolo contendere) of willfully engaging in illegal conduct constituting a felony or a gross misdemeanor involving an intentional act of fraud, misrepresentation, theft, embezzlement or dishonesty under federal or state law (or comparable illegal conduct under the laws of any foreign jurisdiction) which is materially and demonstrably injurious to the Corporation or which impairs the Executive's ability to perform substantially his duties with the Corporation. An act or failure to act will be considered "gross" or "willful" for this purpose only if done, or omitted to be done, by the Executive in bad faith and without reasonable belief that it was in, or not opposed to, the best interests of the Corporation. Any act, or failure to act, based upon authority given pursuant to a resolution duly adopted by the Board or governing body of the Corporation (or a committee thereof) or based upon the advice of counsel for the Corporation will be conclusively presumed to be done, or omitted to be done, by the Executive in good faith and in the best interests of the Corporation. Executive's attention to matters not directly related to the business of the Corporation will not provide a basis for termination for Cause so long as the Board did not expressly disapprove in writing of his engagement in such activities either before or within a reasonable period of time after the Board knew or could reasonably have known that the Executive engaged in those activities. Notwithstanding the foregoing, the Executive may not be terminated for Cause unless and until there has been delivered to Executive a 1 copy of a resolution duly adopted by the affirmative vote of not less than two-thirds of the entire membership of the Board (excluding such Executive) at a meeting of the Board called and held for such purpose (after reasonable notice to such Executive and an opportunity for such Executive, together with his counsel, to be heard before the Board), finding that in the good faith opinion of the Board such Executive engaged in the conduct set forth in paragraphs (a), (b) or (c) above and specifying the particulars thereof in detail." 4. Paragraph 20 of the Employment Agreement is hereby amended by adding to the end of the first sentence the following: "and the Corporation hereby irrevocably consents to the jurisdiction of the federal and state courts sitting in the State of New York for purposes of enforcing this Agreement." 5. Paragraph 25 of the Employment Agreement is hereby amended by deleting Paragraph 25 in its entirety and replacing it with the following: "25. Disputes. (a) If the Executive so elects, any dispute, controversy or claim arising under or in connection with this Agreement will be settled exclusively by binding arbitration in Rochester, New York in accordance with the Employee Benefit Plan Claims Arbitration Rules of the American Arbitration Association, incorporated by referenced herein. Judgment may be entered on the arbitrator's award in any court having jurisdiction; provided that, the Executive may seek specific performance of his right to receive benefits until the Termination Date during the pendency of any dispute or controversy arising under or in connection with this Agreement. (b) If the Executive does not elect arbitration to resolve a dispute, claim or controversy, he may pursue all other available legal remedies. (c) Any review by an arbitrator or a court of competent jurisdiction of a decision made by the Board at any time after a Change in Control shall be de novo, and any such Board determination shall not be entitled to deference. (d) The Corporation will not assert in any dispute or controversy with the Executive arising under or in connection with this Agreement the Executive's failure to exhaust administrative remedies. (e) In the event of any dispute, claim or controversy arising out of or in connection with this Agreement, if the Executive prevails on any of the material issues involved in any such dispute, claim or controversy, the Corporation shall pay to the Executive immediately upon demand all reasonable expenses (including without limitation attorneys' fees) incurred by the Executive in connection therewith. (f) If the Corporation refuses or otherwise fails to make a payment when due under this Agreement and it is ultimately determined that the Executive is entitled to such payment, such payment shall be increased to reflect an interest factor, compounded annually, equal to the prime rate in effect as of the date the payment was first due plus five points. For this purpose, the prime rate shall be based on the rate identified by Chase Manhattan Bank as its prime rate in New York City." 6. The Employment Agreement is further amended by adding the following as new Paragraphs 26 through 31: "26. Definitions. For purposes of this Agreement, the capitalized terms set forth herein and not otherwise defined shall have the meanings set forth in Appendix A attached hereto which shall have the same force and effect as if included as a Paragraph in this Amendment and shall apply when interpreting the terms of this Agreement. 27. Termination Employment in Connection with a Change in Control. (a) Eligibility. If the Executive's employment is terminated during the Protection Period either: (i) by the Corporation without Cause, or (ii) by the Executive for Good Reason, the Corporation will provide the Executive with the payments and benefits set forth in Paragraph 28 below (collectively, the "Enhanced 2 Severance Benefits"), accelerated vesting and exercisability of stock based compensation under Paragraph 29 and a Gross-Up Payment for "Excise Tax" (as defined in Paragraph 30) under Paragraph 30. If the Executive terminates employment with the Corporation under any other circumstances, he shall not be entitled to Enhanced Severance Benefits under Paragraph 28, but may be entitled to (c) benefits under Paragraph 11 hereunder, and (d) accelerated vesting and exercisability of stock based compensation under Paragraph 29 and a Gross-Up Payment for Excise Tax under Paragraph 30 by remaining employed with the Corporation as of a Change in Control. In no event shall Executive be entitled to Enhanced Severance Benefits under Paragraph 28 and to benefits under Paragraph 11. (b) Process for Termination of Employment. During the Protection Period, any termination of the Executive's employment by the Executive for Good Reason or by the Corporation for Cause shall be communicated by written Notice of Termination from the party terminating employment hereunder to the other party hereto in accordance with Paragraph 17. A "Notice of Termination" shall mean, for purposes of this Agreement, a written notice given in good faith and with a reasonable belief that Good Reason or Cause, as the case may be, has occurred, which shall indicate the specific termination provision in this Agreement relied upon and shall set forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive's employment under the provision so indicated. Any Notice of Termination must specify a Termination Date and any Notice of Termination for Cause shall include a copy of the relevant resolution of the Board action taken in accordance with the terms of this Agreement to terminate the Executive's employment for Cause. (c) Compensation and Benefits before Termination Date. During the period beginning on the date the Executive or the Corporation, as the case may be, receives Notice of Termination and ending on the Termination Date, the Corporation will continue to pay the Executive his Base Pay and cause his continued participation in all Benefit Plans in accordance with the terms of such Benefit Plans. (d) Rights Under Other Plans, Policies, Practices and Agreements. Other than to the extent expressly provided herein, this Agreement does not supersede any other plans, policies, and/or practices of the Corporation. To the extent that any provision of any Benefit Plan limits, qualifies or is inconsistent with any of the benefits provided under this Agreement, then, for purposes of this Agreement, while such other Benefit Plans remains in force, the provisions of this Agreement will control and such provision of such other Benefit Plan will be deemed to have been superseded and to be of no force or effect, as if such other agreement had been formally amended to the extent necessary to accomplish such purpose. Nothing in this Agreement prevents or limits the Executive's continuing or future participation in any Benefit Plan provided by the Corporation and nothing in this Agreement limits or otherwise affects the rights the Executive may have under any Benefit Plans with the Corporation. Amounts that are vested benefits or which the Executive is otherwise entitled to receive under any Benefit Plan with the Corporation at or subsequent to the Termination Date will be payable in accordance with such Benefit Plan. 28. Enhanced Severance Benefits. (a) Cash Payment. The Executive will be entitled to a cash payment equal to two (2) times Base Pay (disregarding any change in Base Pay that constitutes Good Reason). The benefit provided under this Paragraph 28(a) will be distributed in a single lump sum within ten business days after the Termination Date or, if later, within ten business days following the effective date of the Change in Control. (b) Continuation of Certain Welfare Benefits. (i) During the period described in Paragraph 28(b)(ii) below, the Corporation will maintain, or continue to reimburse or pay on behalf of the Executive, as the case may be, medical, dental and life insurance plans which by their terms cover the Executive and his family members and dependents under the same terms and at the same cost to the Executive and his family members and dependents as similarly situated executives who continue to be employed by the Corporation (without regard to any reduction in such benefits that constitutes Good Reason). The continuation period under applicable federal and state continuation laws will begin to run from the date on which coverage under this Paragraph ends. (ii) For purposes of Paragraph 28(b)(i) above, the continuation period with respect to any particular plan is the period beginning on the Termination Date and ending on the earlier of: (x) the last day of the twelfth month that begins after the Termination Date, (y) the date after Termination Date on which the 3 Executive first becomes eligible to participate in the plan of another employer providing comparable benefits to the Executive and his eligible family members and dependents which plan does not contain any exclusion or limitation with respect to any pre-existing condition of the Executive or any eligible family member or dependent who would otherwise be covered under the Corporation's plan but for this clause (y), or (z) the date of the Executive's death. (iii) To the extent the Executive incurs a liability for Taxes in connection with a benefit provided pursuant to Paragraph 28(b) which he would not have incurred had he been an active employee of the Corporation participating in one of the Corporation's Benefit Plans, the Corporation shall make a Gross-Up Payment for any such Taxes to the Executive. For purposes of applying the foregoing, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. The payment pursuant to this subparagraph will be made within ten days after the Executive's remittal of a written request therefor, accompanied by a statement indicating the basis for and amount of the liability. (c) Extended Exercise Period for Stock Options. Any stock options issued by the Corporation and held by the Executive shall remain exercisable until thirty-six months following the Termination Date, but in no event beyond the stock option's maximum exercise period (without regard to any provisions that shortens the exercise period in connection with termination of employment or otherwise). 29. Accelerated Vesting and Exercisability. If a Change in Control occurs while the Executive is employed by the Corporation or after the Executive has terminated employment with the Corporation under circumstances entitling him to Enhanced Severance Benefits, (a) all stock options previously granted to the Executive by the Corporation shall become fully vested and exercisable as of the date of the Change in Control, whether or not otherwise exercisable and vested as of that date, and (b) shares of restricted Corporation stock previously awarded to the Executive shall become fully vested. 30. Excise Tax Equalization. The Corporation will cause its independent auditors promptly to review, at the Corporation's sole expense, the applicability of Paragraph 4999 of the Code to any payment or distribution of any type by the Corporation or its Affiliates to or for the benefit of the Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement, any Benefit Plan or otherwise (the "Total Payments"). The Corporation shall engage the auditor so that its review is completed no later than the Change in Control. If the auditor determines that the Total Payments result in an excise tax imposed by Paragraph 4999 of the Code or any comparable state or local law, or any interest or penalties with respect to such excise tax (such excise tax, together with any such interest and penalties, are collectively referred to as the "Excise Tax") and if the Executive is entitled to Enhanced Severance Benefits or accelerated vesting or exercisability of equity compensation under Paragraph 29, or both, the Corporation shall make a Gross-Up Payment for any Excise Taxes to the Executive within ten business days after the Termination Date, but in no event later than the due date for the payments of any excise tax. For purposes of the foregoing determination, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. If any tax authority determines that a greater Excise Tax should be imposed upon the Total Payments than is determined by the Corporation's independent auditors pursuant to this Paragraph 30, the Executive is entitled to receive from the Corporation the full Gross-Up Payment calculated on the basis of the amount of Excise Tax determined to be payable by such tax authority within ten business days after he notifies the Corporation of such determination. 31. Miscellaneous. (a) Successors and Assigns. (i) The Corporation will require any Successor to expressly assume and agree to perform the obligations of this Agreement in the same manner and to the same extent that the Corporation would be required to perform if no such succession had taken place except as specifically required to the contrary hereunder. Failure of the Corporation to obtain such assumption and agreement at least three business days prior to the time a Person becomes a Successor (or where the Corporation does not have at least three business days' advance notice that a Person may become a Successor, within one business day after having notice that such Person may become or has become a Successor) will constitute Good Reason for termination of the Executive's employment. The date on which any such succession becomes effective will be deemed the Termination Date and Notice of Termination will be deemed to have been timely given by the Executive. A Successor has no rights, authority or power with respect to this Agreement prior to a Change in Control. 4 (ii) This Agreement is for the benefit of, and is enforceable by, the Executive, his personal and legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees; provided that, the Executive may not otherwise assign any of his rights or delegate any of his obligations under this Agreement. If the Executive dies after becoming entitled to, but before receiving, any amounts payable under this Agreement, all such amounts, unless otherwise specifically provided to the contrary in this Agreement, will be paid in accordance with the terms of this Agreement to the Executive's devisee, legatee or other designee or, if there be no such designee, to the Executive's estate. (b) No Mitigation or Set-Off. The Executive will not be required to mitigate the amount of any benefits the Corporation becomes obligated to provide in connection with this Agreement by seeking other employment or otherwise. The Corporation has no right to set-off benefits owed under this Agreement against amounts owed or claimed to be owed by the Executive to the Corporation under this Agreement or otherwise. (c) Taxes. All benefits to be provided to the Executive in connection with the this Agreement will be subject to required withholding of federal, state and local income, excise and employment-related taxes. (d) Survival. The respective obligations of, and benefits afforded to, the Corporation and the Executive which, by their express terms or clear meaning, survive termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be, will remain in full force and effect according to their terms notwithstanding the termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be. (e) Benefits as Eligible Compensation under Other Benefit Plans. Unless otherwise expressly provided therein, benefits paid or payable under this Agreement will not be deemed to be salary or compensation for purposes of determining the benefits to which the Executive may be entitled under any other Benefit Plan sponsored, maintained or contributed to by the Corporation." 7. Except as amended as set forth in this First Amendment, the Employment Agreement shall remain in full force and effect in accordance with its terms. IN WITNESS WHEREOF, this First Amendment has been executed by the Corporation, by its duly authorized representative, and by Executive, as of the Effective Date. EXECUTIVE CORPORATION /s/ Thomas M. Fitzgerald /s/ Loren G. Peterson - ------------------------------ ----------------------------- By: Loren G. Peterson Title: President and CEO 5 APPENDIX A DEFINITIONS Whenever the following capitalized terms are used in the Agreement, they shall have the meaning specified below. Affiliate "Affiliate" shall mean: (a) any corporation at least a majority of whose outstanding securities ordinarily having the right to vote at elections of directors is owned directly or indirectly by the Corporation; or (b) any other form of business entity in which the Corporation, by virtue of a direct or indirect ownership interest, has the right to elect a majority of the members of such entity's governing body. Base Pay "Base Pay" shall mean the Executive's base salary at the highest annual rate in effect immediately prior to the Change in Control or at the time Notice of Termination is given, whichever is greater, disregarding any decrease which constitutes Good Reason for the Executive's termination of employment. Base Pay includes only regular cash salary and wages and is determined before any reduction for deferrals pursuant to any nonqualified deferred compensation plan or arrangement, qualified cash or deferred arrangement or cafeteria plan. Beneficial Owner "Beneficial Owner" shall have the meaning ascribed to such term in Rule 13d-3 of the General Rules and Regulations under the Exchange Act. Benefit Plan "Benefit Plan" is (a) employee benefit plan as defined in Paragraph 3(3) of ERISA, (b) a cafeteria plan described in Paragraph 125 of the Code, (c) a plan, policy or practice providing for paid vacation, other paid time off or short- or long-term profit sharing, bonus or incentive payments, or (d) stock option, stock purchase, restricted stock, phantom stock, stock appreciation right or other equity-based compensation plan that is sponsored, maintained or contributed to by the Corporation or its Affiliates for the benefit of employees (and/or their families and dependents) generally or the Executive (and/or the Executive's family and dependents) in particular. Board "Board" is the board of directors of the Corporation duly qualified and acting at the time in question. On and after the date of a Change in Control, any duty of the Board in connection with this Agreement is non-delegable and any attempt by the Board to delegate any such duty is ineffective. Change in Control A "Change in Control" shall mean the first of the following events to occur: (a) Any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing at least thirty percent or, in the case of Elan Corporation and its Affiliates in the aggregate (collectively, the "Elan Group"), at least fifty percent, of the combined voting power of the Corporation's then outstanding securities; (b) During any twenty-four month consecutive period beginning on or after October 1, 2001, individuals who at the beginning of such period constituted a majority of the Board of Directors cease for any reason during any day during any such period to constitute a majority thereof; provided, however, that any director who is not in office at the beginning of such twenty-four month period, but whose election by the Board or whose nomination for election by the Company's shareholders was to fill a vacancy caused by death or retirement and was 6 approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of such period or whose election or nomination for election was previously so approved shall be deemed to have been in office at the beginning of such period for purposes of this definition; (c) the stockholders of the Corporation approve a merger or consolidation of the Corporation with any other Corporation or agreement of exchange involving the Corporation ("Merger"), other than (1) a Merger which would result in the voting securities of the Corporation outstanding as of October 1, 2001 continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent of the combined voting power of the voting securities of the Corporation or such surviving entity outstanding immediately after the Merger, or (2) a Merger effected to implement a recapitalization of the Corporation (or similar transaction) in which no Person acquires thirty percent or more, or in the case of Elan Group in the aggregate, fifty percent or more, of the combined voting power of the Corporation's then outstanding securities; or (d) the stockholders of the Corporation approve a plan of complete liquidation of the Corporation or an agreement for the sale, lease, exchange or other transfer (in one transaction or a series of related transactions) or disposition by the Corporation of all or substantially all of the Corporation's assets. Code "Code" shall mean the Internal Revenue Code of 1986, as amended. Any reference to a specific provision of the Code includes a reference to such provision as it may be amended from time to time and to any successor provision. Effective Date "Effective Date" shall mean the Effective Date of the First Amendment. ERISA "ERISA" shall mean the Employee Retirement Income Security Act of 1974, as amended. Any reference to a specific provision of ERISA includes a reference to such provision as it may be amended from time to time and to any successor provision. Exchange Act The "Exchange Act" shall mean the Securities Exchange Act of 1934, as amended. Any reference to a specific provision of the Exchange Act or to any rule or regulation thereunder includes a reference to such provision as it may be amended from time to time and to any successor provision. Good Reason "Good Reason" shall mean the occurrence of one or more of the following events (regardless of whether any other reason, other than Cause, for such termination exists or has occurred, including without limitation other employment): (a) failure to elect or reelect or otherwise maintain the Executive in the offices or positions that the Executive held immediately prior to the Change in Control; (b) a change in the nature or scope of the authorities, powers, functions, duties or responsibilities attached to the position with the Corporation that the Executive held immediately prior to the Change in Control, as reasonably determined by the Executive; (c) a reduction by the Corporation in the Executive's Base Pay or an adverse change in the form or timing of the payment thereof, as in effect immediately prior to the Potential Change in Control or as thereafter increased; 7 (d) the failure by the Corporation to cover the Executive under Benefit Plans that, in the aggregate, provide substantially similar benefits to the Executive and/or his family and dependents at a substantially similar total cost to the Executive (e.g., premiums, deductibles, co-pays, out of pocket maximums, required contributions, Taxes and the like) relative to the highest benefits and lowest total costs under the Benefit Plans in which the Executive (and/or his family or dependents) is participating at any time during the period between the Potential Change in Control and the Change in Control; (e) the Corporation's requiring the Executive to be based more than fifty miles from where his office is located immediately prior to the Change in Control, except for required travel on the Corporation's business, and then only to the extent substantially consistent with the business travel obligations which the Executive undertook on behalf of the Corporation during the ninety day period ending on the date of the Potential Change in Control (without regard to travel related to or in anticipation of the Change in Control); (f) the failure of the Corporation to obtain from any Successor the assent to this Agreement as required under Paragraph 32(a)(i); (g) any purported termination by the Corporation of the Executive's employment which is not properly effected pursuant to a Notice of Termination and pursuant to any other requirements of this Agreement and, for purposes of this Agreement, no such purported termination will be effective; or (h) any refusal by the Corporation to continue to allow the Executive to attend to matters or engage in activities not directly related to the business of the Corporation which, at any time prior to the Potential Change in Control, the Executive was not expressly prohibited by the Corporation from attending to or engaging in. The Executive's continued employment does not constitute consent to, or waiver of any rights arising in connection with, any circumstance constituting Good Reason. Notwithstanding the foregoing, the occurrence of an event that would otherwise constitute Good Reason hereunder shall cease to be an event constituting Good Reason if the Executive does not provide a Notice of Termination to the Corporation within one hundred eighty days of the date that the Executive first becomes aware of the occurrence of such event. Termination by the Executive of his employment for Good Reason as defined hereunder will constitute Good Reason for all purposes of this Agreement, even if the Executive may also thereby be deemed to have "retired" under any applicable retirement programs of the Corporation. Gross-Up Payment "Gross-Up Payment" shall mean an amount payable to the Executive such that, after the payment of all Taxes attributable to any item of compensation subject to gross-up under this Agreement by the Corporation, there remains a balance sufficient to pay the Taxes being reimbursed. Person A "Person" shall mean any individual, corporation, partnership, group, association or other "person," as such term is used in Paragraph 14(d) of the Exchange Act, other than the Corporation, any Affiliate or any benefit plan sponsored by the Corporation or an Affiliate. 8 Potential Change in Control A "Potential Change in Control" shall be the first of the following events to occur: (a) the Corporation enters into an agreement, the consummation of which would result in the occurrence of a Change in Control; (b) any Person (including the Corporation) publicly announces an intention to take or to consider taking actions which, if consummated, would constitute a Change in Control; or (c) any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing fifteen percent or more of the combined voting power of the Corporation's then outstanding securities, increases its beneficial ownership of such securities by one percentage point or more over the percentage so owned by such Person on the Effective Date, other than an increase in ownership percentage due to the payment of dividends by the issuance of additional securities of the Corporation; or (d) the Board adopts a resolution to the effect that, for purposes of this Agreement, a Potential Change in Control has occurred. The Board shall not be precluded from adopting a resolution to the effect that, for purposes of this Agreement, it is the good faith opinion of the Board that a Potential Change in Control has been abandoned and that a Potential Change in Control no longer exists. An event shall not be a Potential Change in Control for purposes of this Agreement if a Change in Control does not occur within twelve months of such event. Successor A "Successor" shall mean any Person that succeeds to, or has the practical ability to control (either immediately or solely with the passage of time), the Corporation's business directly, by merger, consolidation or other form of business combination, or indirectly, by purchase of the Corporation's outstanding securities ordinarily having the right to vote at the election of directors, all or substantially all of its assets or otherwise. Taxes "Taxes" shall mean the incremental federal, state and local income, excise and other taxes (including Excise Taxes), penalties and interest payable by the Executive with respect to any applicable item of income. Termination Date "Termination Date" shall mean: (1) in the case of an employment termination by the Corporation for Cause or by the Executive for Good Reason, the date specified as the Executive's last day of employment in the Notice of Termination, which shall not be less than ten business days after the date such Notice of Termination is deemed given in accordance with Paragraph 18, or (2) in any other case, the last day worked by the Executive as reflected on the Corporation's payroll records. Notwithstanding the foregoing, if the Corporation terminates the Executive's employment for Cause and the Executive has not previously expressly agreed in writing to the termination, then within the thirty day period after the Executive's receipt of the Notice of Termination, the Executive may notify the Corporation that a dispute exists concerning the termination, in which event the Termination Date will be the date set either by mutual written agreement of the parties or by the arbitrators or a court under the dispute resolution provisions in Paragraph 25. During the pendency of any such dispute, the Executive will continue to make himself available to provide services to the Corporation and the Corporation will continue to pay the Executive his full compensation and benefits in effect immediately prior to the date on which the Notice of Termination is given (without regard to any changes to such compensation or benefits which constitute Good Reason) and until the dispute is resolved in accordance with Paragraph 25. The Executive will be entitled to retain the full amount of any such compensation and benefits without regard to the resolution of the dispute unless the arbitrators or judge decide(s) that the Executive's claim of a dispute was frivolous or advanced by the Executive in bad faith. 9 EX-10.6.5A 4 c68433ex10-6_5a.txt AMENDMENT TO EMPLOYMENT AGREEMENT EXHIBIT 10.6.5A THIS FIRST AMENDMENT TO EMPLOYMENT AGREEMENT ("First Amendment") is made this first day of October, 2001 (the "Effective Date"), by and between Sheffield Pharmaceuticals, Inc. (the "Corporation") and Scott A. Hoffmann (the "Executive"). WHEREAS, the Compensation Committee of the Board of Directors has determined that a possibility of a Change in Control of the Corporation exists and appropriate steps should be taken to reinforce and encourage the continued attention and dedication of certain management to their assigned duties. NOW, THEREFORE, in consideration of the covenants and agreements contained herein, intending to be legally bound, the Corporation and Executive hereby agree, effective as of the Effective Date, as follows: 8. Paragraph 3 of the Employment Agreement by and between the Corporation and Executive dated November 16, 1998 (the "Employment Agreement") is hereby amended by deleting the third sentence in its entirety and adding to the second sentence the following: "; provided that, no such notice by the Corporation shall be effective and the term of this Agreement shall be extended for an additional year if a Potential Change in Control shall have occurred or occurs at any time prior to the date of such notice or within the twelve month period beginning on the date of such notice. Further, if a Change in Control shall have occurred at any time during the term of this Agreement, then notwithstanding any provision hereof to the contrary, the term shall continue in effect for: (i) the remainder of the month in which the Change in Control occurred, and (ii) a term of twenty-four months beyond the month in which such Change in Control occurred; provided that, if any obligations of the Corporation hereunder shall not have been fully and finally discharged at the end of such twenty-four month period, the term shall continue until such obligations shall have been finally discharged in full. The period commencing on the earlier of a Potential Change in Control (if applicable) or Change in Control and ending with the conclusion of such twenty-four month period shall be referred to hereinafter as the "Protection Period." 9. Paragraph 12(c) of the Employment Agreement is hereby deleted in its entirety. 10. Paragraph 14 of the Employment Agreement is hereby amended by deleting Paragraph 14 in its entirety and replacing it with the following: "14. Termination for Cause. The Corporation may at any time upon written notice to Executive terminate Executive's employment for Cause. For purposes of this Agreement, the following shall constitute Cause: (a) the Executive's gross misconduct which is materially and demonstrably injurious to the Corporation; (b) the Executive's willful and continued failure to perform substantially his duties with the Corporation (other than a failure resulting from the Executive's incapacity due to bodily injury or physical or mental illness) after a demand for substantial performance is delivered to the Executive by the Board which specifically identifies the manner in which the Board believes that the Executive has not substantially performed his duties and provides for a reasonable period of time within which the Executive may take corrective measures; or (c) the Executive's conviction (including a plea of nolo contendere) of willfully engaging in illegal conduct constituting a felony or a gross misdemeanor involving an intentional act of fraud, misrepresentation, theft, embezzlement or dishonesty under federal or state law (or comparable illegal conduct under the laws of any foreign jurisdiction) which is materially and demonstrably injurious to the Corporation or which impairs the Executive's ability to perform substantially his duties with the Corporation. An act or failure to act will be considered "gross" or "willful" for this purpose only if done, or omitted to be done, by the Executive in bad faith and without reasonable belief that it was in, or not opposed to, the best interests of the Corporation. Any act, or failure to act, based upon authority given pursuant to a resolution duly adopted by the Board or governing body of the Corporation (or a committee thereof) or based upon the advice of counsel for the Corporation will be conclusively presumed to be done, or omitted to be done, by the Executive in good faith and in the best interests of the Corporation. Executive's attention to matters not directly related to the business of the Corporation will not provide a basis for termination for Cause so long as the Board did not expressly disapprove in writing of his engagement in such activities either before or within a reasonable period of time after the Board knew or could reasonably have known that the Executive engaged in those activities. Notwithstanding the 1 foregoing, the Executive may not be terminated for Cause unless and until there has been delivered to Executive a copy of a resolution duly adopted by the affirmative vote of not less than two-thirds of the entire membership of the Board (excluding such Executive) at a meeting of the Board called and held for such purpose (after reasonable notice to such Executive and an opportunity for such Executive, together with his counsel, to be heard before the Board), finding that in the good faith opinion of the Board such Executive engaged in the conduct set forth in paragraphs (a), (b) or (c) above and specifying the particulars thereof in detail." 11. Paragraph 21 of the Employment Agreement is hereby amended by adding to the end of the first sentence the following: "and the Corporation hereby irrevocably consents to the jurisdiction of the federal and state courts sitting in the State of Missouri for purposes of enforcing this Agreement." 12. Paragraph 26 of the Employment Agreement is hereby amended by deleting Paragraph 26 in its entirety and replacing it with the following: "26. Disputes. (a) If the Executive so elects, any dispute, controversy or claim arising under or in connection with this Agreement will be settled exclusively by binding arbitration in St. Louis, Missouri in accordance with the Employee Benefit Plan Claims Arbitration Rules of the American Arbitration Association, incorporated by referenced herein. Judgment may be entered on the arbitrator's award in any court having jurisdiction; provided that, the Executive may seek specific performance of his right to receive benefits until the Termination Date during the pendency of any dispute or controversy arising under or in connection with this Agreement. (b) If the Executive does not elect arbitration to resolve a dispute, claim or controversy, he may pursue all other available legal remedies. (c) Any review by an arbitrator or a court of competent jurisdiction of a decision made by the Board at any time after a Change in Control shall be de novo, and any such Board determination shall not be entitled to deference. (d) The Corporation will not assert in any dispute or controversy with the Executive arising under or in connection with this Agreement the Executive's failure to exhaust administrative remedies. (e) In the event of any dispute, claim or controversy arising out of or in connection with this Agreement, if the Executive prevails on any of the material issues involved in any such dispute, claim or controversy, the Corporation shall pay to the Executive immediately upon demand all reasonable expenses (including without limitation attorneys' fees) incurred by the Executive in connection therewith. (f) If the Corporation refuses or otherwise fails to make a payment when due under this Agreement and it is ultimately determined that the Executive is entitled to such payment, such payment shall be increased to reflect an interest factor, compounded annually, equal to the prime rate in effect as of the date the payment was first due plus five points. For this purpose, the prime rate shall be based on the rate identified by Chase Manhattan Bank as its prime rate in New York City." 13. The Employment Agreement is further amended by adding the following as new Paragraphs 27 through 32: "27. Definitions. For purposes of this Agreement, the capitalized terms set forth herein and not otherwise defined shall have the meanings set forth in Appendix A attached hereto which shall have the same force and effect as if included as a Paragraph in this Amendment and shall apply when interpreting the terms of this Agreement. 28. Termination Employment in Connection with a Change in Control. (a) Eligibility. If the Executive's employment is terminated during the Protection Period either: (i) by the Corporation without Cause, or (ii) by the Executive for Good Reason, the Corporation will provide 2 the Executive with the payments and benefits set forth in Paragraph 29 below (collectively, the "Enhanced Severance Benefits"), accelerated vesting and exercisability of stock based compensation under Paragraph 30 and a Gross-Up Payment for "Excise Tax" (as defined in Paragraph 31) under Paragraph 31. If the Executive terminates employment with the Corporation under any other circumstances, he shall not be entitled to Enhanced Severance Benefits under Paragraph 29, but may be entitled to (c) benefits under Paragraph 12 hereunder, and (d) accelerated vesting and exercisability of stock based compensation under Paragraph 30 and a Gross-Up Payment for Excise Tax under Paragraph 31 by remaining employed with the Corporation as of a Change in Control. In no event shall Executive be entitled to Enhanced Severance Benefits under Paragraph 29 and to benefits under Paragraph 12. (b) Process for Termination of Employment. During the Protection Period, any termination of the Executive's employment by the Executive for Good Reason or by the Corporation for Cause shall be communicated by written Notice of Termination from the party terminating employment hereunder to the other party hereto in accordance with Paragraph 18. A "Notice of Termination" shall mean, for purposes of this Agreement, a written notice given in good faith and with a reasonable belief that Good Reason or Cause, as the case may be, has occurred, which shall indicate the specific termination provision in this Agreement relied upon and shall set forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive's employment under the provision so indicated. Any Notice of Termination must specify a Termination Date and any Notice of Termination for Cause shall include a copy of the relevant resolution of the Board action taken in accordance with the terms of this Agreement to terminate the Executive's employment for Cause. (c) Compensation and Benefits before Termination Date. During the period beginning on the date the Executive or the Corporation, as the case may be, receives Notice of Termination and ending on the Termination Date, the Corporation will continue to pay the Executive his Base Pay and cause his continued participation in all Benefit Plans in accordance with the terms of such Benefit Plans. (d) Rights Under Other Plans, Policies, Practices and Agreements. Other than to the extent expressly provided herein, this Agreement does not supersede any other plans, policies, and/or practices of the Corporation. To the extent that any provision of any Benefit Plan limits, qualifies or is inconsistent with any of the benefits provided under this Agreement, then, for purposes of this Agreement, while such other Benefit Plans remains in force, the provisions of this Agreement will control and such provision of such other Benefit Plan will be deemed to have been superseded and to be of no force or effect, as if such other agreement had been formally amended to the extent necessary to accomplish such purpose. Nothing in this Agreement prevents or limits the Executive's continuing or future participation in any Benefit Plan provided by the Corporation and nothing in this Agreement limits or otherwise affects the rights the Executive may have under any Benefit Plans with the Corporation. Amounts that are vested benefits or which the Executive is otherwise entitled to receive under any Benefit Plan with the Corporation at or subsequent to the Termination Date will be payable in accordance with such Benefit Plan. 29. Enhanced Severance Benefits. (a) Cash Payment. The Executive will be entitled to a cash payment equal to one and one-half (1.5) times Base Pay (disregarding any change in Base Pay that constitutes Good Reason). The benefit provided under this Paragraph 29(a) will be distributed in a single lump sum within ten business days after the Termination Date or, if later, within ten business days following the effective date of the Change in Control. (b) Continuation of Certain Welfare Benefits. (i) During the period described in Paragraph 29(b)(ii) below, the Corporation will maintain, or continue to reimburse or pay on behalf of the Executive, as the case may be, medical, dental and life insurance plans which by their terms cover the Executive and his family members and dependents under the same terms and at the same cost to the Executive and his family members and dependents as similarly situated executives who continue to be employed by the Corporation (without regard to any reduction in such benefits that constitutes Good Reason). The continuation period under applicable federal and state continuation laws will begin to run from the date on which coverage under this Paragraph ends. (ii) For purposes of Paragraph 29(b)(i) above, the continuation period with respect to any particular plan is the period beginning on the Termination Date and ending on the earlier of: (x) the last day 3 of the twelfth month that begins after the Termination Date, (y) the date after Termination Date on which the Executive first becomes eligible to participate in the plan of another employer providing comparable benefits to the Executive and his eligible family members and dependents which plan does not contain any exclusion or limitation with respect to any pre-existing condition of the Executive or any eligible family member or dependent who would otherwise be covered under the Corporation's plan but for this clause (y), or (z) the date of the Executive's death. (iii) To the extent the Executive incurs a liability for Taxes in connection with a benefit provided pursuant to Paragraph 29(b) which he would not have incurred had he been an active employee of the Corporation participating in one of the Corporation's Benefit Plans, the Corporation shall make a Gross-Up Payment for any such Taxes to the Executive. For purposes of applying the foregoing, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. The payment pursuant to this subparagraph will be made within ten days after the Executive's remittal of a written request therefor, accompanied by a statement indicating the basis for and amount of the liability. (c) Extended Exercise Period for Stock Options. Any stock options issued by the Corporation and held by the Executive shall remain exercisable until thirty-six months following the Termination Date, but in no event beyond the stock option's maximum exercise period (without regard to any provisions that shortens the exercise period in connection with termination of employment or otherwise). 30. Accelerated Vesting and Exercisability. If a Change in Control occurs while the Executive is employed by the Corporation or after the Executive has terminated employment with the Corporation under circumstances entitling him to Enhanced Severance Benefits, (a) all stock options previously granted to the Executive by the Corporation shall become fully vested and exercisable as of the date of the Change in Control, whether or not otherwise exercisable and vested as of that date, and (b) shares of restricted Corporation stock previously awarded to the Executive shall become fully vested. 31. Excise Tax Equalization. The Corporation will cause its independent auditors promptly to review, at the Corporation's sole expense, the applicability of Paragraph 4999 of the Code to any payment or distribution of any type by the Corporation or its Affiliates to or for the benefit of the Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement, any Benefit Plan or otherwise (the "Total Payments"). The Corporation shall engage the auditor so that its review is completed no later than the Change in Control. If the auditor determines that the Total Payments result in an excise tax imposed by Paragraph 4999 of the Code or any comparable state or local law, or any interest or penalties with respect to such excise tax (such excise tax, together with any such interest and penalties, are collectively referred to as the "Excise Tax") and if the Executive is entitled to Enhanced Severance Benefits or accelerated vesting or exercisability of equity compensation under Paragraph 30, or both, the Corporation shall make a Gross-Up Payment for any Excise Taxes to the Executive within ten business days after the Termination Date, but in no event later than the due date for the payments of any excise tax. For purposes of the foregoing determination, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. If any tax authority determines that a greater Excise Tax should be imposed upon the Total Payments than is determined by the Corporation's independent auditors pursuant to this Paragraph 31, the Executive is entitled to receive from the Corporation the full Gross-Up Payment calculated on the basis of the amount of Excise Tax determined to be payable by such tax authority within ten business days after he notifies the Corporation of such determination. 32. Miscellaneous. (a) Successors and Assigns. (i) The Corporation will require any Successor to expressly assume and agree to perform the obligations of this Agreement in the same manner and to the same extent that the Corporation would be required to perform if no such succession had taken place except as specifically required to the contrary hereunder. Failure of the Corporation to obtain such assumption and agreement at least three business days prior to the time a Person becomes a Successor (or where the Corporation does not have at least three business days' advance notice that a Person may become a Successor, within one business day after having notice that such Person may become or has become a Successor) will constitute Good Reason for termination of the Executive's employment. The date on which any such succession becomes effective will be deemed the Termination Date and Notice of Termination will be deemed to have been timely given by the Executive. A Successor has no rights, authority or power with respect to this Agreement prior to a Change in Control. 4 (ii) This Agreement is for the benefit of, and is enforceable by, the Executive, his personal and legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees; provided that, the Executive may not otherwise assign any of his rights or delegate any of his obligations under this Agreement. If the Executive dies after becoming entitled to, but before receiving, any amounts payable under this Agreement, all such amounts, unless otherwise specifically provided to the contrary in this Agreement, will be paid in accordance with the terms of this Agreement to the Executive's devisee, legatee or other designee or, if there be no such designee, to the Executive's estate. (b) No Mitigation or Set-Off. The Executive will not be required to mitigate the amount of any benefits the Corporation becomes obligated to provide in connection with this Agreement by seeking other employment or otherwise. The Corporation has no right to set-off benefits owed under this Agreement against amounts owed or claimed to be owed by the Executive to the Corporation under this Agreement or otherwise. (c) Taxes. All benefits to be provided to the Executive in connection with the this Agreement will be subject to required withholding of federal, state and local income, excise and employment-related taxes. (d) Survival. The respective obligations of, and benefits afforded to, the Corporation and the Executive which, by their express terms or clear meaning, survive termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be, will remain in full force and effect according to their terms notwithstanding the termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be. (e) Benefits as Eligible Compensation under Other Benefit Plans. Unless otherwise expressly provided therein, benefits paid or payable under this Agreement will not be deemed to be salary or compensation for purposes of determining the benefits to which the Executive may be entitled under any other Benefit Plan sponsored, maintained or contributed to by the Corporation." 14. Except as amended as set forth in this First Amendment, the Employment Agreement shall remain in full force and effect in accordance with its terms. IN WITNESS WHEREOF, this First Amendment has been executed by the Corporation, by its duly authorized representative, and by Executive, as of the Effective Date. EXECUTIVE CORPORATION /s/ Scott A. Hoffmann /s/ Loren G. Peterson - ------------------------------ ----------------------------- By: Loren G. Peterson Title: President and CEO 5 APPENDIX A DEFINITIONS Whenever the following capitalized terms are used in the Agreement, they shall have the meaning specified below. Affiliate "Affiliate" shall mean: (a) any corporation at least a majority of whose outstanding securities ordinarily having the right to vote at elections of directors is owned directly or indirectly by the Corporation; or (b) any other form of business entity in which the Corporation, by virtue of a direct or indirect ownership interest, has the right to elect a majority of the members of such entity's governing body. Base Pay "Base Pay" shall mean the Executive's base salary at the highest annual rate in effect immediately prior to the Change in Control or at the time Notice of Termination is given, whichever is greater, disregarding any decrease which constitutes Good Reason for the Executive's termination of employment. Base Pay includes only regular cash salary and wages and is determined before any reduction for deferrals pursuant to any nonqualified deferred compensation plan or arrangement, qualified cash or deferred arrangement or cafeteria plan. Beneficial Owner "Beneficial Owner" shall have the meaning ascribed to such term in Rule 13d-3 of the General Rules and Regulations under the Exchange Act. Benefit Plan "Benefit Plan" is (a) employee benefit plan as defined in Paragraph 3(3) of ERISA, (b) a cafeteria plan described in Paragraph 125 of the Code, (c) a plan, policy or practice providing for paid vacation, other paid time off or short- or long-term profit sharing, bonus or incentive payments, or (d) stock option, stock purchase, restricted stock, phantom stock, stock appreciation right or other equity-based compensation plan that is sponsored, maintained or contributed to by the Corporation or its Affiliates for the benefit of employees (and/or their families and dependents) generally or the Executive (and/or the Executive's family and dependents) in particular. Board "Board" is the board of directors of the Corporation duly qualified and acting at the time in question. On and after the date of a Change in Control, any duty of the Board in connection with this Agreement is non-delegable and any attempt by the Board to delegate any such duty is ineffective. Change in Control A "Change in Control" shall mean the first of the following events to occur: (a) Any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing at least thirty percent or, in the case of Elan Corporation and its Affiliates in the aggregate (collectively, the "Elan Group"), at least fifty percent, of the combined voting power of the Corporation's then outstanding securities; (b) During any twenty-four month consecutive period beginning on or after October 1, 2001, individuals who at the beginning of such period constituted a majority of the Board of Directors cease for any reason during any day during any such period to constitute a majority thereof; provided, however, that any director who is not in office at the beginning of such twenty-four month period, but whose election by the Board or whose nomination for election by the Company's shareholders was to fill a vacancy caused by death or retirement and was 6 approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of such period or whose election or nomination for election was previously so approved shall be deemed to have been in office at the beginning of such period for purposes of this definition; (c) the stockholders of the Corporation approve a merger or consolidation of the Corporation with any other Corporation or agreement of exchange involving the Corporation ("Merger"), other than (1) a Merger which would result in the voting securities of the Corporation outstanding as of October 1, 2001 continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent of the combined voting power of the voting securities of the Corporation or such surviving entity outstanding immediately after the Merger, or (2) a Merger effected to implement a recapitalization of the Corporation (or similar transaction) in which no Person acquires thirty percent or more, or in the case of Elan Group in the aggregate, fifty percent or more, of the combined voting power of the Corporation's then outstanding securities; or (d) the stockholders of the Corporation approve a plan of complete liquidation of the Corporation or an agreement for the sale, lease, exchange or other transfer (in one transaction or a series of related transactions) or disposition by the Corporation of all or substantially all of the Corporation's assets. Code "Code" shall mean the Internal Revenue Code of 1986, as amended. Any reference to a specific provision of the Code includes a reference to such provision as it may be amended from time to time and to any successor provision. Effective Date "Effective Date" shall mean the Effective Date of the First Amendment. ERISA "ERISA" shall mean the Employee Retirement Income Security Act of 1974, as amended. Any reference to a specific provision of ERISA includes a reference to such provision as it may be amended from time to time and to any successor provision. Exchange Act The "Exchange Act" shall mean the Securities Exchange Act of 1934, as amended. Any reference to a specific provision of the Exchange Act or to any rule or regulation thereunder includes a reference to such provision as it may be amended from time to time and to any successor provision. Good Reason "Good Reason" shall mean the occurrence of one or more of the following events (regardless of whether any other reason, other than Cause, for such termination exists or has occurred, including without limitation other employment): (a) failure to elect or reelect or otherwise maintain the Executive in the offices or positions that the Executive held immediately prior to the Change in Control; (b) a change in the nature or scope of the authorities, powers, functions, duties or responsibilities attached to the position with the Corporation that the Executive held immediately prior to the Change in Control, as reasonably determined by the Executive; (c) a reduction by the Corporation in the Executive's Base Pay or an adverse change in the form or timing of the payment thereof, as in effect immediately prior to the Potential Change in Control or as thereafter increased; 7 (d) the failure by the Corporation to cover the Executive under Benefit Plans that, in the aggregate, provide substantially similar benefits to the Executive and/or his family and dependents at a substantially similar total cost to the Executive (e.g., premiums, deductibles, co-pays, out of pocket maximums, required contributions, Taxes and the like) relative to the highest benefits and lowest total costs under the Benefit Plans in which the Executive (and/or his family or dependents) is participating at any time during the period between the Potential Change in Control and the Change in Control; (e) the Corporation's requiring the Executive to be based more than fifty miles from where his office is located immediately prior to the Change in Control, except for required travel on the Corporation's business, and then only to the extent substantially consistent with the business travel obligations which the Executive undertook on behalf of the Corporation during the ninety day period ending on the date of the Potential Change in Control (without regard to travel related to or in anticipation of the Change in Control); (f) the failure of the Corporation to obtain from any Successor the assent to this Agreement as required under Paragraph 32(a)(i); (g) any purported termination by the Corporation of the Executive's employment which is not properly effected pursuant to a Notice of Termination and pursuant to any other requirements of this Agreement and, for purposes of this Agreement, no such purported termination will be effective; or (h) any refusal by the Corporation to continue to allow the Executive to attend to matters or engage in activities not directly related to the business of the Corporation which, at any time prior to the Potential Change in Control, the Executive was not expressly prohibited by the Corporation from attending to or engaging in. The Executive's continued employment does not constitute consent to, or waiver of any rights arising in connection with, any circumstance constituting Good Reason. Notwithstanding the foregoing, the occurrence of an event that would otherwise constitute Good Reason hereunder shall cease to be an event constituting Good Reason if the Executive does not provide a Notice of Termination to the Corporation within one hundred eighty days of the date that the Executive first becomes aware of the occurrence of such event. Termination by the Executive of his employment for Good Reason as defined hereunder will constitute Good Reason for all purposes of this Agreement, even if the Executive may also thereby be deemed to have "retired" under any applicable retirement programs of the Corporation. Gross-Up Payment "Gross-Up Payment" shall mean an amount payable to the Executive such that, after the payment of all Taxes attributable to any item of compensation subject to gross-up under this Agreement by the Corporation, there remains a balance sufficient to pay the Taxes being reimbursed. Person A "Person" shall mean any individual, corporation, partnership, group, association or other "person," as such term is used in Paragraph 14(d) of the Exchange Act, other than the Corporation, any Affiliate or any benefit plan sponsored by the Corporation or an Affiliate. 8 Potential Change in Control A "Potential Change in Control" shall be the first of the following events to occur: (a) the Corporation enters into an agreement, the consummation of which would result in the occurrence of a Change in Control; (b) any Person (including the Corporation) publicly announces an intention to take or to consider taking actions which, if consummated, would constitute a Change in Control; or (c) any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing fifteen percent or more of the combined voting power of the Corporation's then outstanding securities, increases its beneficial ownership of such securities by one percentage point or more over the percentage so owned by such Person on the Effective Date, other than an increase in ownership percentage due to the payment of dividends by the issuance of additional securities of the Corporation; or (d) the Board adopts a resolution to the effect that, for purposes of this Agreement, a Potential Change in Control has occurred The Board shall not be precluded from adopting a resolution to the effect that, for purposes of this Agreement, it is the good faith opinion of the Board that a Potential Change in Control has been abandoned and that a Potential Change in Control no longer exists. An event shall not be a Potential Change in Control for purposes of this Agreement if a Change in Control does not occur within twelve months of such event. Successor A "Successor" shall mean any Person that succeeds to, or has the practical ability to control (either immediately or solely with the passage of time), the Corporation's business directly, by merger, consolidation or other form of business combination, or indirectly, by purchase of the Corporation's outstanding securities ordinarily having the right to vote at the election of directors, all or substantially all of its assets or otherwise. Taxes "Taxes" shall mean the incremental federal, state and local income, excise and other taxes (including Excise Taxes), penalties and interest payable by the Executive with respect to any applicable item of income. Termination Date "Termination Date" shall mean: (1) in the case of an employment termination by the Corporation for Cause or by the Executive for Good Reason, the date specified as the Executive's last day of employment in the Notice of Termination, which shall not be less than ten business days after the date such Notice of Termination is deemed given in accordance with Paragraph 18, or (2) in any other case, the last day worked by the Executive as reflected on the Corporation's payroll records. Notwithstanding the foregoing, if the Corporation terminates the Executive's employment for Cause and the Executive has not previously expressly agreed in writing to the termination, then within the thirty day period after the Executive's receipt of the Notice of Termination, the Executive may notify the Corporation that a dispute exists concerning the termination, in which event the Termination Date will be the date set either by mutual written agreement of the parties or by the arbitrators or a court under the dispute resolution provisions in Paragraph 26. During the pendency of any such dispute, the Executive will continue to make himself available to provide services to the Corporation and the Corporation will continue to pay the Executive his full compensation and benefits in effect immediately prior to the date on which the Notice of Termination is given (without regard to any changes to such compensation or benefits which constitute Good Reason) and until the dispute is resolved in accordance with Paragraph 26. The Executive will be entitled to retain the full amount of any such compensation and benefits without regard to the resolution of the dispute unless the arbitrators or judge decide(s) that the Executive's claim of a dispute was frivolous or advanced by the Executive in bad faith. 9 EX-10.6.6 5 c68433ex10-6_6.txt EMPLOYMENT AGREEMENT EXHIBIT 10.6.6 EMPLOYMENT AGREEMENT AGREEMENT made as of the 3rd day of August, 1998, by and between Sheffield Pharmaceuticals, Inc., a Delaware corporation (the "Corporation"), and Thomas A. Armer, who currently resides at 5619 Overbrook, Ann Arbor, MI 48105 ("Employee"). WITNESSETH: WHEREAS, in July 1998, the Corporation, through a wholly-owned subsidiary acquired from Aeroquip Corporation certain intellectual property relating to an aerosol enhancement technology (the ADDS Technology"); WHEREAS, Employee was employed by Aeroquip Corporation in the development of the ADDS Technology; WHEREAS, the Corporation desires to employ and retain Employee as Vice President - Pulmonary Delivery Systems. upon the terms and subject to the conditions of this Agreement; and NOW, THEREFORE, in consideration of the premises and the mutual covenants hereinafter set forth, the parties hereto agree as follows: 1. Employment of Employee. The Corporation hereby employs Employee as Vice President - Pulmonary Delivery Systems to perform the duties and responsibilities incidental to such office, subject at all times to the control and direction of the Board of Directors of the Corporation. 2. Acceptance of Employment; Time and Attention, Etc. (a) Employee hereby accepts such employment and agrees that throughout the period of his employment hereunder, except as hereinafter provided, he will devote his full business and professional time in utilizing his business and professional expertise, with proper attention, knowledge and skills faithfully, diligently and to the best of his ability in furtherance of the business of the Corporation and its subsidiaries and will perform the duties assigned to his pursuant to Paragraph 1 hereof. As Vice President - Pulmonary Delivery Systems, Employee shall also perform such specific duties and shall exercise such specific authority related to the business and operations of the Corporation and its subsidiaries as may be reasonably assigned to Employee from time to time by the Chief Executive Officer or his designee. (b) Employee shall at all times be subject to, observe and carry out such rules, regulations, policies, directions and restrictions as the Board of Directors of the Corporation shall from time to time establish. During the period of his employment hereunder, Employee shall not, directly or indirectly, accept employment or compensation from, or perform services of any nature for, any business enterprise other than the Corporation and its subsidiaries. Notwithstanding the foregoing in this Paragraph 2, Employee shall not be precluded from engaging in recreational, educational (including, but not limited to, teaching or attending educational classes, seminars or other educational endeavors) and other activities, which activities do not materially interfere with his duties hereunder and shall occur during vacations, holidays and other periods outside of business hours. 3. Term. Except as otherwise provided herein, the term of Employee's employment hereunder shall commence on the date hereof and shall continue to and including July 31, 2000. Unless terminated earlier in accordance with the terms hereof, this Agreement shall automatically be extended for one or more additional consecutive one year terms unless either party notifies the other party in writing at least 60 days before the end of the then current term (including the initial term) of its or his desire to terminate this Agreement. The last day of the term of this Agreement pursuant to this Paragraph 3 (including any early termination pursuant to the terms hereof) is referred to herein as the "Termination Date." 4. Compensation. (a) As compensation for his services hereunder, the Corporation shall pay to Employee (i) a base annual salary at the rate of $120,000, payable in equal installments in accordance with the normal payroll practices of the Corporation but in no event less frequently than semi-monthly, and (ii) such bonuses based on performance criteria relating to the development of the Corporation's pulmonary development program as may he agreed to between the Employee and the Corporation. All compensation paid to Employee shall be subject to withholding and other employment taxes imposed by applicable law. 1 (b) During the period of Employee's employment hereunder, Employee shall not be entitled to any additional compensation (other than as to stock options granted pursuant to this Agreement) for rendering employment services to subsidiaries of the Corporation or for serving in any office of the Corporation or any of its subsidiaries to which he is elected or appointed. 5. Stock Options. (a) As additional compensation for his services hereunder, the Corporation shall grant to Employee an option to acquire a total of 125,000 shares of Sheffield Pharmaceuticals, Inc. common stock at an exercise price per share equal to the closing sale price of the Corporation's common stock as reported by the American Stock Exchange on the date hereof, with the terms of such option to be evidenced by an option letter agreement in the form annexed as Exhibit "A" hereto. (b) On the date that the Corporation receives market approval from the U.S. Food and Drug Administration (FDA) for its initial product based on the ADDS Technology (the "Market Approval Date"), the Corporation shall grant to Employee an option to acquire an additional 40,000 shares of Sheffield Pharmaceuticals, Inc. common stock, with the terms of such option to be evidenced by an option letter agreement in the form annexed as Exhibit "A" containing such modification to such form as are set forth in the following sentence. Such option shall (i) have an exercise price per share equal to the closing sale price of the Corporation's common stock as reported by the American Stock Exchange (or another exchange that constitutes the principal exchange for the Corporation's common stock) on the Market Approval Date, (ii) be first exercisable on the first anniversary of the Market Approval Date and (iii) expire on the fifth anniversary of the Market Approval Date. "ADDS Technology" means the aerosol enhancing technology purchased by the Corporation from Aeroquip Corporation. 6. Additional Benefits; Vacation. (a) In addition to such base salary, Employee shall receive and be entitled to participate, to the extent he is eligible under the terms and conditions thereof, in any profit sharing, pension, retirement, hospitalization, disability, medical service, insurance or other employee benefit plan generally available to employees of the Corporation that may be in effect from time to time during the period of Employee's employment hereunder. (b) Employee shall be entitled to two (2) weeks' paid vacation in respect of each 12-month period during the term of his employment hereunder, such vacation to be taken at times mutually agreeable to Employee and the Chief Executive Officer or his designee. (c) Employee shall be entitled to recognize as holidays all days recognized as such by the Corporation. 7. Reimbursement of Expenses. The Corporation shall reimburse Employee in accordance with applicable policies of the Corporation for all expenses reasonably incurred by his in connection with the performance of his duties hereunder and the business of the Corporation, upon the submission to the Corporation of appropriate receipts or vouchers. 8. Restrictive Covenant. (a) In consideration of the Corporation's entering into this Agreement, Employee agrees that during the period of his employment hereunder and, in the event of termination of this Agreement (i) by the Corporation upon Employee becoming Disabled (as such term is defined in Paragraph 13), (ii) by the Corporation for Cause (as that term is defined in Paragraph 13 hereof) or (iii) by Employee otherwise than for Employer Breach (as that term is defined in Paragraph 14 hereof), for a further period of six (6) months thereafter, he will not (x) directly or indirectly own, manage, operate, join, control, participate in, invest in, whether as an officer, director, employee, partner, investor or otherwise, any business entity that is engaged in a directly competitive business (as hereinafter defined) to that of the Corporation or any of its subsidiaries within the United States of America (or any of its territories or possessions), any country located in the Caribbean, the United Kingdom, the Republic of Ireland or Italy, (y) for himself or on behalf of any other person, partnership, corporation or entity, call on any customer of the Corporation or any of its subsidiaries for the purpose of soliciting away, diverting or taking away any customer from the Corporation or its subsidiaries, or (z) solicit any person then engaged as an employee, representative, agent, independent contractor or otherwise by the Corporation or any of its subsidiaries, to terminate his or her relationship with the Corporation or any of its subsidiaries. For purposes of this Agreement, the term "directly competitive business" shall mean any business that is then involved in the research, development, manufacturing or commercialization in any way of any product, compound, device or method that is or becomes a part of the 2 Corporation's business or the business of any of its subsidiaries during Employee's employment by the Corporation or any of its subsidiaries, including such products, compounds, devices, methods or other intellectual property which constitute the Predisclosed Technologies (as defined in Paragraph 10 below). Nothing contained in this Agreement shall be deemed to prohibit Employee from investing his funds in securities of an issuer if the securities of such issuer are listed for trading on a national securities exchange or are traded in the over-the-counter market and Employee's holdings therein represent less than 10% of the total number of shares or principal amount of the securities of such issuer outstanding. (b) Employee acknowledges that the provisions of this Paragraph 8 are reasonable and necessary for the protection of the Corporation, and that each provision, and the period or periods of time, geographic areas and types and scope of restrictions on the activities specified herein are, and are intended to be, divisible. In the event that any provision of this Paragraph 8, including any sentence, clause or part hereof, shall be deemed contrary to law or invalid or unenforceable in any respect by a court of competent jurisdiction, the remaining provisions shall not be affected, but shall, subject to the discretion of such court, remain in full force and effect. 9. Confidential Information. (a) Employee shall hold in a fiduciary capacity for the benefit of the Corporation and its subsidiaries all confidential information, knowledge and data relating to or concerned with its research, development, information and projects, as well as its operations, sales, business and affairs, and he shall not, at any time during his employment hereunder and for two years thereafter, use, disclose or divulge any such information, knowledge or data to any person, firm or corporation other than to the Corporation and its subsidiaries or their respective designees or except as may otherwise be reasonably required or desirable in connection with the business and affairs of the Corporation and its subsidiaries. (b) Notwithstanding anything to the contrary contained herein, Employee's obligations under Paragraph 9(a) hereof shall not apply to any information which: (i) becomes rightfully known to Employee subsequent or prior to his employment by the Corporation; (ii) is or becomes available to the public other than as a result of wrongful disclosure by Employee; (iii) becomes available to Employee subsequent to his employment by the Corporation on a confidential basis from a source other than the Corporation or its agents which source has a right to disclose such information; or (iv) results from research and development and/or commercial operations at any time by or on behalf of any person, company or other entity with which or with whom Employee shall become associated (in a manner consistent with the terms of this Agreement) subsequent to his employment by the Corporation or its agents totally independent from any disclosure from the Corporation or its agents. (c) Notwithstanding anything to the contrary contained herein, in the event that Employee becomes legally compelled to disclose any confidential information, Employee will provide the Corporation with prompt notice so that the Corporation may seek a protective order or other appropriate remedy. In the event that such protective order or other remedy is not obtained, Employee shall furnish only such confidential information which is legally required to be disclosed. 10. Intellectual Property/Assignment. (a) Any idea, invention, design, written material, manual, system, procedure, improvement, development or discovery conceived, developed, created or made by Employee alone or with others, during the period of his employment hereunder and applicable to the business of the Corporation or any of its subsidiaries, whether or not patentable or registrable, shall become the sole and exclusive property of the Corporation or such subsidiary. Employee shall disclose the same promptly and completely to the Corporation and shall, during the period of his employment hereunder and at any time and from time to time hereafter at no cost to Employee (i) execute all documents reasonably requested by the Corporation for vesting in the Corporation or any of its subsidiaries the entire right, title and interest in and to the same, (ii) execute all documents reasonably requested by the Corporation for filing and prosecuting such applications for patents, trademarks, service marks and/or copyrights the Corporation, in its sole discretion, may desire to prosecute, and (iii) give the Corporation all 3 assistance it reasonably requires, including the giving of testimony in any suit, action or proceeding, in order to obtain, maintain and protect the Corporation's right therein and thereto. (b) The Corporation will consider existing intellectual property developed collaboratively by Employee, Dr. Nahed Mohsen and Mr. Richard Pavkov and disclosed to the Corporation prior to employment and set forth in Schedule A hereto, provided such intellectual property is unencumbered (the "Predisclosed Technologies"). At the Corporation's discretion, the Corporation may choose to progress, to patent, and to commercialize any such Predisclosed Technology. Such technology shall be the property of the Corporation. Employee agrees to execute all necessary assignments to transfer any of the Predisclosed Technologies to Corporation ownership. In the event that the Corporation commercializes this technology, Dr. Armer, Dr. Mohsen, and Mr. Pavkov shall, collectively, be granted a single royalty of two percent (2%) of the sales or revenue received by the Corporation for such commercialization and payable for the life of the applicable patent from the Predisclosed Technologies as a finders fee. The allocation of the two percent (2%) royalty shall be equally divided amongst Employee, Dr. Mohsen, and Mr. Pavkov. 11. Equitable Relief. The parties hereto acknowledge that Employee's services are unique and that, in the event of a breach or a threatened breach by Employee of any of his obligations under Paragraphs 8, 9 or 10 this Agreement, the Corporation shall not have an adequate remedy at law. Accordingly, in the event of any such breach or threatened breach by Employee, the Corporation shall be entitled to such equitable and injunctive relief as may be available to restrain Employee and any business, firm, partnership, individual, corporation or entity participating in such breach or threatened breach from the violation of the provisions of Paragraph 8, 9 or 10 hereof. Nothing herein shall be construed as prohibiting the Corporation from pursuing any other remedies available at law or in equity for such breach or threatened breach, including the recovery of damages and the immediate termination of the employment of Employee hereunder, if and to the extent permitted hereunder. 12. Termination of Agreement; Termination of Employment; Severance; Survival. (a) This Agreement and Employee's employment hereunder shall terminate upon the first to occur of the following: (i) Employee becoming Disabled (as such term is defined in Paragraph 13); (ii) Employee's death; (iii) termination of Employee's employment by the Corporation for Cause or pursuant to subparagraph (b) of this Paragraph 12; (iv) termination of Employee's employment for Employer Breach; and (v) the termination of this Agreement at the end of the term of this Agreement on the Termination Date pursuant to Paragraph 3. (b) Notwithstanding anything to the contrary contained in this Agreement, in the event of the termination of the Employee's employment by the Corporation for any reason (other than for Cause or by reason of Employee becoming Disabled), Employee shall be paid a severance payment in an amount equal to $5,000 multiplied by the number of full months that Employee has been employed by the Corporation prior to such termination, with such amount not to exceed $60,000, payable in six equal monthly installments, with the first installment being payable on the date falling two weeks after the date of such termination and each additional installment being paid every month after such date until such severance is paid in full. (c) Paragraphs 7-12 of this Agreement shall survive the termination of Employee's employment hereunder, except in the case of termination pursuant to Paragraph 15. Notwithstanding anything contained in this Agreement to the contrary, the royalty payable pursuant to Paragraph 10 (b) shall be payable to Employee regardless of any termination of this Agreement. 13. Disability. In the event that during the term of his employment by the Corporation Employee shall become Disabled (as that term is hereinafter defined) he shall continue to receive the full amount of the base salary to which he was theretofore entitled for a period of six months after he shall be deemed to have become Disabled (the "First Disability Payment Period"). If the First Disability Payment Period shall end prior to the Termination Date, Employee thereafter shall be entitled to receive salary at an annual rate equal to 80% of his then current base salary for a further period ending on the earlier of (i) six months thereafter or (ii) the Termination Date (the "Second Disability Payment Period"). Upon the expiration of the Second Disability Payment Period, Employee shall not be entitled to receive any further payments on account of his base salary until he shall cease to be Disabled and shall have resumed his duties hereunder and provided that the Corporation shall not have theretofore terminated this Agreement as hereinafter provided. The Corporation may terminate Employee's employment hereunder at any time after Employee is Disabled, upon at least 10 days' prior written notice; provided, however, that such termination shall not relieve the Corporation from its obligation to make the payments to Employee described above in this Paragraph 13. For the purposes of this Agreement, Employee shall be deemed to have become Disabled when (x) by reason of 4 physical or mental incapacity, Employee is not able to perform his duties hereunder for a period of 90 consecutive days or for 120 days in any consecutive 180-day period and (y) Employee's physician or a physician designated by the Corporation shall have determined that it is unlikely that Employee will be able, by reason of physical or mental incapacity, to perform a substantial portion of his duties hereunder for the following 120 days. In the event that Employee shall dispute any determination of his disability pursuant to clauses (x) or (y) above, the matter shall be resolved by the determination of three physicians qualified to practice medicine in the United States of America, one to be selected by each of the Corporation and Employee and the third to be selected by the designated physicians. If Employee shall receive benefits under any disability policy maintained by the Corporation, the Corporation shall be entitled to deduct the amount equal to the benefits so received from base salary that it otherwise would have been required to pay to Employee as provided above. 14. Termination for Cause. The Corporation may at any time upon written notice to Employee terminate Employee's employment for Cause. For purposes of this Agreement, the following shall constitute Cause: (i) the willful and repeated failure of Employee to perform any material duties hereunder or gross negligence of Employee in the performance of such duties, and if such failure or gross negligence is susceptible to cure by Employee, the failure to effect such cure within twenty (20) days after written notice of such failure or gross negligence is given to Employee; (ii) except as permitted hereunder, unexplained, willful and regular absences of Employee from the Corporation; (iii) excessive use of alcohol or illegal drugs, interfering with the performance of Employees duties hereunder; (iv) indictment for a crime of theft, embezzlement, fraud, misappropriation of funds, other acts of dishonesty or the violation of any law or ethical rule relating to Employee's employment; (v) indicted for any other felony or other crime involving moral turpitude by Employee; or (vi) the breach by Employee of any of the provisions of paragraphs 8, 9 or 10 and if such breach is susceptible of cure by Employee, the failure to effect such cure within twenty (20) days after written notice of such breach is given to Employee. For purposes of this Agreement, an action shall be considered "willful" if it is done intentionally, purposely or knowingly, distinguished from an act done carelessly, thoughtlessly or inadvertently. In any such event, Employee shall be entitled to receive his base salary to and including the date of termination. 15. Termination for Employer Breach. Employee may upon written notice to the Corporation terminate this Agreement in the event of the breach by the Corporation of any material provision of this Agreement, and if such breach is susceptible of cure, the failure to effect such cure within 20 days after written notice of such breach is given to the Corporation (an "Employer Breach"). Employee's right to terminate this Agreement under this Paragraph 14 shall be in addition to any other remedies Employee may have under law or equity. 16. Insurance Policies. The Corporation shall have the right from time to time to purchase, increase, modify or terminate insurance policies on the life of Employee for the benefit of the Corporation, in such amounts as the Corporation shall determine in its sole discretion. In connection therewith, Employee shall, at such time or times and at such place or places as the Corporation may reasonably direct, submit himself to such physical examinations and execute and deliver such documents as the Corporation may reasonably deem necessary or desirable; provided that such examinations shall be performed by, and that such documents shall be delivered only to, qualified physicians and/or medical representatives of licensed insurance companies. At Employee's written request upon the termination of Employee's employment under this Agreement (other than for Cause or as result of Employee's death), the Corporation shall assign to Employee the Corporation's interest in such life insurance policies (to the extent such policies are so assignable by their terms), whereupon Employee shall assume all obligations of the Corporation in respect thereof. 17. Entire Agreement; Amendment. This Agreement constitutes the entire agreement of the parties hereto relating to the subject matter hereof and any prior agreement between the Corporation and Employee is hereby superseded and terminated effective immediately and shall be without further force or effect. No amendment or modification himself shall be valid or binding unless made in writing and signed by the party against whom enforcement thereof is sought. 18. Notices. Any notice required, permitted or desired to be given pursuant to any of the provisions of this Agreement shall be delivered in person or sent by responsible overnight delivery service or sent by certified mail, return receipt requested, postage and fees prepaid, if to the Corporation, at its address set forth above to the attention of the Corporation's Chief Executive Officer and, if to Employee, at his address set forth above. Either of the parties hereto may at any time and from time to time change the address to which notice shall be sent hereunder by notice to the other party given under this Paragraph 18. Notices shall be deemed effective upon receipt. 5 19. No Assignment; Binding Effect. Neither this Agreement, nor the right to receive any payments hereunder, may be assigned by either party without the other party's prior written consent. This Agreement shall be binding upon Employee, his heirs, executors and administrators and upon the Corporation, its successors and assigns. 20. Waivers. No course of dealing nor any delay on the part of either party in exercising any rights hereunder shall operate as a waiver of any such rights. No waiver of any default or breach of this Agreement shall be deemed a continuing waiver or a waiver of any other breach or default. 21. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, except that body of law relating to choice of laws. 22. Invalidity. If any clause, paragraph, section or part of this Agreement shall be held or declared to be void, invalid or illegal, for any reason, by any court of competent jurisdiction, such provision shall be ineffective but shall not in any way invalidate or affect any other clause, paragraph, section or part of this Agreement. 23. Further Assurances. Each of the parties shall execute such documents and take such other actions as may be reasonably requested by the other party to carry out the provisions and purposes of this Agreement in accordance with its terms. 24. Headings. The headings contained in this Agreement have been inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement. 25. Publicity. The Corporation and Employee agree that they will not make any press releases or other announcements prior to or at the time of execution of this Agreement with respect to the terms contemplated hereby, except as required by applicable law, without the prior approval of the other party, which approval will not be unreasonably withheld. IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the day and year first above written. SHEFFIELD PHARMACEUTICALS, INC. BY: /s/ Carl F. Siekmann ---------------------------- Name: Carl F. Siekmann Title: Executive VP /s/ Thomas A. Armer ---------------------------------- Thomas A. Armer 6 Schedule A to Employment Agreement Intellectual Property 7 INVENTION DESCRIPTION METHOD AND APPARATUS FOR PRECISELY METERING AND GENERATING DRY POWDER AEROSOLS HISTORY: Carlos Mastrangelo (Univ. of Michigan), Richard Pavkov, Nahed Mohsen, June 1997 - request for proposal describes apparatus metering and actuation method. Nahed Mohsen, Richard Pavkov, Neal Lii, Tom Garver, Tom Armer, September 1997 - aerosol generation and actuation method. Tom Armer, Nahed Mohsen, December 1997 - method for deposition of precisely metered powders. Don Frei (Wood, Herron & Evans) and Tom Armer - May 1998, prosecution strategy. DESCRIPTION: This invention teaches a method to precisely meter unit-doses of a dry, powdered compound and to disperse it as an aerosol into an air stream. It also describes the apparatus and a method to load powdered doses into the apparatus. Unit doses are defined as individual powder caches, precisely measured to contain a specific amount of the powder compound. The amount can range from 5 micrograms up to 500 milligrams. The dose precision ranges from 1 microgram for the smallest dose size, to 50 micrograms for the largest dose size. The dry powder is composed of finely disperse compound(s) with median diameters ranging from 0.5 micron to 20 microns. The powder is loaded into precisely partitioned cells on a substrate by electrostatic deposition (such as the commercial system from Delsys). Each cell in the partitioned zones constitutes a unit dose. The cells are separated from each other by a finite distance or a physical barrier to avoid overlap and intermixing. For example the partitioned cells can be an array of cylindrical, rhombohedral, tetrahedral or pyramidal mounds or bumps. Alternatively they can be rectangular or circular, octagonal, hexagonal or other polygonal-perimeter walled-cells. The substrate can be a flat surface or it can be preformed into shallow-walled lattice. The volume of the partitions and deposit density control the mass of powder in each partition. The deposit packing density is sufficiently low to minimize irreversible agglomeration of the powder particles, but high enough to minimize settling. Ideally the packing density corresponds to a level just at the threshold of the critical packing fraction characteristic of the powder shape and size distribution. One (1) to several thousand cells could be formed on the substrate. The substrate can be formed into three-dimensional shapes. For example it could be cylindrical with the cells on the internal surface or on the external surface. The substrate can be polymer, metallic or compose of silicon, alumina or other ceramic material. The cells can be etched, pressed, stamped or machined (optically or mechanically) into the surface. In certain embodiment it may be desirable to render the substrate porous so that air may flow, under the influence of an applied pressure gradient, through the cell to aid in evacuating the deposited powder. After deposition the cells are sealed with a thin foil of plastic and/or metal. The foil can be applied by lamination, vapor deposition, gas phase polymerization or by spraying. The foil serves to protect the powder deposit from spilling, contamination, and mechanical or environmental disruption due to the effects of handling, humidity, temperature and exposure to uncontrolled environments. In preferred embodiments a polymer foil, coated with a vapor deposited metal can practically package the powder cell array for up to several years of storage. Thus the above description discloses a method to precisely meter, package and store unit doses of powdered compound(s). The method of aerosol actuation and generation is next described. 8 The partitioned cells and foil covering incorporate features which allow each partition to be individually opened. For example the foil can be embossed with a grid of conductors such as aluminum, graphite, nichrome. Alternatively the grid can be incorporated into the shallow-walled partitions, or into the surface of the substrate. The grid pattern is correspondent to the perimeters or a portion or the perimeters of the cells. Electrical current passed selectively through the grid on the partition perimeters heats sufficiently to melt or degrade the foil to that the covering disintegrates, melts, or otherwise fails mechanically to rupture the cell cover. The heating is sufficiently localized to avoid degradation of the physical, chemical or biological properties of the powder inside the cell. Simultaneously, a force field is applied to the deposit so that as the cell ruptures the powder is ejected into the media above the substrate. This force field can be: an electrostatic field, a mechanical force such as vibrations from an electromechanical or an acoustic generator, or a convective gradient such as a fluid flowing through the cell or tangentially above the cell. The force field is sufficient to disperse the powder into the media adjacent to the substrate. Thus each cell can individually ruptured and the contents discharged into the media. The medium into which the cells are discharged is typically gaseous, but it could be vapor or liquid state fluid. Multiple partitions could be discharged simultaneously or in a specific combinatorial sequence. Different compounds can be deposited into different cells in the same array and discharged in a specific sequence or combination. ADVANTAGES: Existing dry powder dispersing technology relies either on a propellant or a carrier powder to disperse the target compound into a carrier media. The described invention eliminates the need for the propellant by using electromechanical or other fluid propulsion mechanisms. This can increase the precision and consistency of dispersion, while reducing cost, size and complexity of the dispersing device. The elimination of the powder carrier increases the dispersion efficiency and affords more precise control of dose metering and particle size distribution. It can also eliminate the presence of unnecessary species in the dispersed aerosol. The partitioning and deposition method provides a highly accurate, pre-metering system to generate precise dose sizes. It eliminates problems with typical unit dose packages (e.g. blister packages or capsules) such as retention of powder in the package, while providing the same packaging and storage stability. The multiplicity of cells provides the equivalent to a reservoir of powder, but provides an accuracy of measurement not available in existing reservoir devices. The ability to discharge cells in specific sequences and combinations enables the ability to customize dosing quantity and composition, while using a single apparatus or powder supply. Because the production of the substrate and filling with powder is comparable to existing blister or capsule packaging, there should be no cost penalty. 9 INVENTION DESCRIPTION METHOD AND APPARATUS FOR USING POROUS PLASTICS TO DISPERSE AND DISPENSE DRUGS FOR INHALATION HISTORY: Disclosed 2/27/98: Thomas Armer, Richard Pavkov DESCRIPTION: Porous material used to control airflow through a conduit thus creating a laminar flow across the cross sectional area of a conduit. Due to the nature of the porous material, it can be molded and machined into numerous shapes allowing for various air flow boundary conditions, i.e. pipes, baffles, frits, plugs, etc. Depending on the shape of the material, the air flow boundary, created by the air moving through the pores, can be used to inhibit deposition on the inner surfaces of a medical device such as a metered dose inhaler (MDI), dry powder inhaler (DPI), nebulizer, etc. The airflow through the material can also be used to displace the momentum of an aerosol burst, such as the bolus of an MDI, to promote dispersion and/or evaporation. Description of Material: Porous plastic consisting of various polymers with a range of pore diameters: o High-density polyethylene (HDPE) Pore size: 35 - 250um o Ultra high molecular weight Polyethylene (UHMW) Pore size: 7 - 40um o Polypropylene (PP) Pore size: 125 - 350um o Polyvinylidene fluoride (PVDF) Pore size: 25um average size o Polytetrafluoroethylene (PTFE) Pore size: 25um average size o Nylon 6 (N6) Pore size: 200um average size o Polyethersulfone (PES) Pore size: 100um average size ADVANTAGES: o Dispersion of air flow o Material creates a boundary of air flow extending from material surface thus allowing counteraction of opposing flows o Molded plastics shapes o Chemical resistant o Machinable o Low cost o Various pore sizes for controlled air flow o Minimizes drug deposition due to surface characteristics 10 OTHER APPLICATIONS: Impregnation of a suitable geometrical shape of the porous plastic with a dry powder drug, such as albuterol. Impregnated plastic is then loaded into a device for dispensing of the drug. Once air is pushed or pulled through the porous plastic the entrapped drug would be carried out by the air flow. Due to the nature of the porous plastic, the drug dose will dispense as a function of the porosity, air flow, time of inhalation, and bulk of the material. The most practical design of this dispensing method would be for single use dosage with a disposable device. The design embodiment would be that of a pack of cigarettes in which each single use device is sealed until the desired time of need. This would be ideal for third world applications (low cost) and for conditions with high humidity since the devices would be sealed until used. 11 INVENTION DESCRIPTION A METHOD TO GENERATE DROPLETS OF PRECISE SIZE AND PRECISE EJECTION VELOCITY HISTORY: Nahed Mohsen, Tom Armer, Rich Pavkov, Richard Oeftering, March 1997- discussion of potential application for acoustic radiation pressure. Nahed Mohsen, Tom Armer, Rich Pavkov, Richard Oeftering and Dan Demiglio (NASA Lewis Research Center), June 1997 - Discussion of experimental design and protocols to generate droplets of insulin. DESCRIPTION: This is a disclosure of a method to generate droplets of precise size and precise ejection velocity. This invention teaches a method to generate precisely uniform size of droplets at a controlled velocity. The method uses acoustic radiation pressure to generate droplets for any liquid medicament. The generator consists of an acoustic transducer that emits a focused tone burst from below a pool of liquid directed at the pools' surface. The burst causes the surface to erupt and form a droplet, which is ejected with an initial velocity. The droplet size can vary over a wide range, since the generator is nozzleless and is not bound strictly to a fixed nozzle diameter. The droplet size can be controlled, since it is proportional to the acoustic wavelength, thus, varying the input frequency varies the droplet size inversely. The droplet size produced can range from 1um to 50um. For finer droplet size, multiple transducer may be used. The acoustic radiation pressure droplet generator can create droplets from liquid solution as well as from liquid suspension systems without clogging since the generator is nozzleless. In addition, the particles in the suspension system would cross the ejection point and would either get ejected along with the liquid or swept a way from the ejection point, thus creating a self cleaning system. The droplet generator consists of a piezoelectric transducer mounted on the end of a buffer rod (sapphire). A spherical focusing lens is positioned at the opposite end of the rod. The lens of the device is submerged below the surface of a liquid pool. The transducer generates a high frequency acoustic tone burst which propagates down the length of the sapphire rod. When it reaches the opposing end, the acoustic waves encounter a spherical focusing lens that transmits the acoustic energy into the liquid pool. The lens causes the acoustic waves to be focused at a small point at the pool surface. The device relies on the acoustic pressure to propel droplets from a small pool of liquid. The pressure is greatest in the beam's focal region, particularly, at the pool surface where the wave reflection occurs. The pressure acts to lift a small column of liquid which appears initially as a small mound. When enough energy is applied to overcome the liquid surface tension, the mound becomes a momentary liquid fountain where each short tone burst emits a single droplet. As one increases the energy level, the droplets begin to form tails, which then break off into satellite droplets. Further increases in the energy causes the process to transition to a continuous fountain. ADVANTAGES: The advantages of the acoustic pressure droplet generator: 1. It produces uniform droplet size distribution, 2. It produces a wide range of droplet size, 3. It can control the ejection velocity of the droplets, 4. It can atomize liquid as well as suspension systems, 5. It can atomize polypeptides and proteins without any molecular chains denaturation, 6. It does not clog, self cleaning system 12 EXHIBIT A TO EMPLOYMENT AGREEMENT SHEFFIELD PHARMACEUTICALS, INC. 425 WOODSMILL ROAD ST. LOUIS, MISSOURI 63017-3441 --------------, 1998 To: [Insert Name & Address of Employee] At a meeting of the Compensation Committee of the Board of Directors of Sheffield Pharmaceuticals, Inc. (the "Company") held on July 15, 1998, the Company authorized the grant to you of an option (the "Option") to purchase _____________________ (___,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company. The Option is being granted in connection with your employment by the Company. Except as provided below, the option may be exercised at anytime and from time after ________________, 199__ and on or prior to _______________, 200__ (on which date the Option will, to the extent not previously exercised, expire).(1) The purchase price per Share payable by you is $______.(2) Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act") , is in effect as to the Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may he sold and the manner in which shares may - ---------- (1) The first date for exercise shall be the date six months after the issuance date of the Option and the last date for exercise shall be the fifth anniversary of such issuance date. (2) Purchase price shall he the closing price of the Company's common stock on the American Stock Exchange as of the date of commencement of employment. 13 be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and-acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the purchase price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. In the event that your employment by the Company is terminated for cause, then the Option shall be immediately canceled upon such termination of employment and you shall have no further rights with respect to the Option. In the event that your employment by the Company is terminated for reasons other than for cause, then you may, during the ninety (90) day period following the date you cease to be employed by the Company, exercise the Option to the extent that you were entitled to exercise it at the date of such termination. To the extent that you were not entitled to exercise the Option at the date of such termination, or if you do not exercise the Option (to the extent you are entitled to exercise) within the time specified in this paragraph, the Option shall terminate. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. The Option does not confer upon any right whatsoever as a stockholder of the Company. Your right to exercise the Option shall not terminate as a result of the termination of your employment by the Company. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, SHEFFIELD PHARMACEUTICALS, INC. BY: ------------------------------ Name: Title: AGREED TO AND ACCEPTED: - ------------------------------- [Name of Employee] 14 Exhibit A STOCK SUBSCRIPTION FORM To: Sheffield Pharmaceuticals, Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Pharmaceuticals, Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated as of _____________, 1998, ______________ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $_____ per share. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company stock records is as follows: Name: --------------------------------------- Address: -------------------------------------------- -------------------------------------------- -------------------------------------------- Very truly yours, -------------------------------- [Name of Employee] 15 EX-10.6.6A 6 c68433ex10-6_6a.txt AMENDMENT TO EMPLOYMENT AGREEMENT EXHIBIT 10.6.6A THIS FIRST AMENDMENT TO EMPLOYMENT AGREEMENT ("First Amendment") is made this first day of October, 2001 (the "Effective Date"), by and between Sheffield Pharmaceuticals, Inc. (the "Corporation") and Thomas A. Armer (the "Executive"). WHEREAS, the Compensation Committee of the Board of Directors has determined that a possibility of a Change in Control of the Corporation exists and appropriate steps should be taken to reinforce and encourage the continued attention and dedication of certain management to their assigned duties. NOW, THEREFORE, in consideration of the covenants and agreements contained herein, intending to be legally bound, the Corporation and Executive hereby agree, effective as of the Effective Date, as follows: 15. Paragraph 3 of the Employment Agreement by and between the Corporation and Executive dated August 3, 1998 (the "Employment Agreement") is hereby amended by deleting the third sentence in its entirety and adding to the second sentence the following: "; provided that, no such notice by the Corporation shall be effective and the term of this Agreement shall be extended for an additional year if a Potential Change in Control shall have occurred or occurs at any time prior to the date of such notice or within the twelve month period beginning on the date of such notice. Further, if a Change in Control shall have occurred at any time during the term of this Agreement, then notwithstanding any provision hereof to the contrary, the term shall continue in effect for: (i) the remainder of the month in which the Change in Control occurred, and (ii) a term of twenty-four months beyond the month in which such Change in Control occurred; provided that, if any obligations of the Corporation hereunder shall not have been fully and finally discharged at the end of such twenty-four month period, the term shall continue until such obligations shall have been finally discharged in full. The period commencing on the earlier of a Potential Change in Control (if applicable) or Change in Control and ending with the conclusion of such twenty-four month period shall be referred to hereinafter as the "Protection Period." 16. Paragraph 12(c) of the Employment Agreement is hereby deleted in its entirety. 17. Paragraph 14 of the Employment Agreement is hereby amended by deleting Paragraph 14 in its entirety and replacing it with the following: "14. Termination for Cause. The Corporation may at any time upon written notice to Executive terminate Executive's employment for Cause. For purposes of this Agreement, the following shall constitute Cause: (a) the Executive's gross misconduct which is materially and demonstrably injurious to the Corporation; (b) the Executive's willful and continued failure to perform substantially his duties with the Corporation (other than a failure resulting from the Executive's incapacity due to bodily injury or physical or mental illness) after a demand for substantial performance is delivered to the Executive by the Board which specifically identifies the manner in which the Board believes that the Executive has not substantially performed his duties and provides for a reasonable period of time within which the Executive may take corrective measures; or (c) the Executive's conviction (including a plea of nolo contendere) of willfully engaging in illegal conduct constituting a felony or a gross misdemeanor involving an intentional act of fraud, misrepresentation, theft, embezzlement or dishonesty under federal or state law (or comparable illegal conduct under the laws of any foreign jurisdiction) which is materially and demonstrably injurious to the Corporation or which impairs the Executive's ability to perform substantially his duties with the Corporation. An act or failure to act will be considered "gross" or "willful" for this purpose only if done, or omitted to be done, by the Executive in bad faith and without reasonable belief that it was in, or not opposed to, the best interests of the Corporation. Any act, or failure to act, based upon authority given pursuant to a resolution duly adopted by the Board or governing body of the Corporation (or a committee thereof) or based upon the advice of counsel for the Corporation will be conclusively presumed to be done, or omitted to be done, by the Executive in good faith and in the best interests of the Corporation. Executive's attention to matters not directly related to the business of the Corporation will not provide a basis for termination for Cause so long as the Board did not expressly disapprove in writing of his engagement in such activities either before or within a reasonable period of time after the Board knew or could reasonably have known that the Executive engaged in those activities. Notwithstanding the 1 foregoing, the Executive may not be terminated for Cause unless and until there has been delivered to Executive a copy of a resolution duly adopted by the affirmative vote of not less than two-thirds of the entire membership of the Board (excluding such Executive) at a meeting of the Board called and held for such purpose (after reasonable notice to such Executive and an opportunity for such Executive, together with his counsel, to be heard before the Board), finding that in the good faith opinion of the Board such Executive engaged in the conduct set forth in paragraphs (a), (b) or (c) above and specifying the particulars thereof in detail." 18. Paragraph 21 of the Employment Agreement is hereby amended by adding to the end of the first sentence the following: "and the Corporation hereby irrevocably consents to the jurisdiction of the federal and state courts sitting in the State of Missouri for purposes of enforcing this Agreement." 19. Paragraph 26 of the Employment Agreement is hereby amended by deleting Paragraph 26 in its entirety and replacing it with the following: "26. Disputes. (a) If the Executive so elects, any dispute, controversy or claim arising under or in connection with this Agreement will be settled exclusively by binding arbitration in St. Louis, Missouri in accordance with the Employee Benefit Plan Claims Arbitration Rules of the American Arbitration Association, incorporated by referenced herein. Judgment may be entered on the arbitrator's award in any court having jurisdiction; provided that, the Executive may seek specific performance of his right to receive benefits until the Termination Date during the pendency of any dispute or controversy arising under or in connection with this Agreement. (b) If the Executive does not elect arbitration to resolve a dispute, claim or controversy, he may pursue all other available legal remedies. (c) Any review by an arbitrator or a court of competent jurisdiction of a decision made by the Board at any time after a Change in Control shall be de novo, and any such Board determination shall not be entitled to deference. (d) The Corporation will not assert in any dispute or controversy with the Executive arising under or in connection with this Agreement the Executive's failure to exhaust administrative remedies. (e) In the event of any dispute, claim or controversy arising out of or in connection with this Agreement, if the Executive prevails on any of the material issues involved in any such dispute, claim or controversy, the Corporation shall pay to the Executive immediately upon demand all reasonable expenses (including without limitation attorneys' fees) incurred by the Executive in connection therewith. (f) If the Corporation refuses or otherwise fails to make a payment when due under this Agreement and it is ultimately determined that the Executive is entitled to such payment, such payment shall be increased to reflect an interest factor, compounded annually, equal to the prime rate in effect as of the date the payment was first due plus five points. For this purpose, the prime rate shall be based on the rate identified by Chase Manhattan Bank as its prime rate in New York City." 20. The Employment Agreement is further amended by adding the following as new Paragraphs 27 through 32: "27. Definitions. For purposes of this Agreement, the capitalized terms set forth herein and not otherwise defined shall have the meanings set forth in Appendix A attached hereto which shall have the same force and effect as if included as a Paragraph in this Amendment and shall apply when interpreting the terms of this Agreement. 28. Termination Employment in Connection with a Change in Control. (a) Eligibility. If the Executive's employment is terminated during the Protection Period either: (i) by the Corporation without Cause, or (ii) by the Executive for Good Reason, the Corporation will provide 2 the Executive with the payments and benefits set forth in Paragraph 29 below (collectively, the "Enhanced Severance Benefits"), accelerated vesting and exercisability of stock based compensation under Paragraph 30 and a Gross-Up Payment for "Excise Tax" (as defined in Paragraph 31) under Paragraph 31. If the Executive terminates employment with the Corporation under any other circumstances, he shall not be entitled to Enhanced Severance Benefits under Paragraph 29, but may be entitled to (c) benefits under Paragraph 12 hereunder, and (d) accelerated vesting and exercisability of stock based compensation under Paragraph 30 and a Gross-Up Payment for Excise Tax under Paragraph 31 by remaining employed with the Corporation as of a Change in Control. In no event shall Executive be entitled to Enhanced Severance Benefits under Paragraph 29 and to benefits under Paragraph 12. (b) Process for Termination of Employment. During the Protection Period, any termination of the Executive's employment by the Executive for Good Reason or by the Corporation for Cause shall be communicated by written Notice of Termination from the party terminating employment hereunder to the other party hereto in accordance with Paragraph 18. A "Notice of Termination" shall mean, for purposes of this Agreement, a written notice given in good faith and with a reasonable belief that Good Reason or Cause, as the case may be, has occurred, which shall indicate the specific termination provision in this Agreement relied upon and shall set forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive's employment under the provision so indicated. Any Notice of Termination must specify a Termination Date and any Notice of Termination for Cause shall include a copy of the relevant resolution of the Board action taken in accordance with the terms of this Agreement to terminate the Executive's employment for Cause. (c) Compensation and Benefits before Termination Date. During the period beginning on the date the Executive or the Corporation, as the case may be, receives Notice of Termination and ending on the Termination Date, the Corporation will continue to pay the Executive his Base Pay and cause his continued participation in all Benefit Plans in accordance with the terms of such Benefit Plans. (d) Rights Under Other Plans, Policies, Practices and Agreements. Other than to the extent expressly provided herein, this Agreement does not supersede any other plans, policies, and/or practices of the Corporation. To the extent that any provision of any Benefit Plan limits, qualifies or is inconsistent with any of the benefits provided under this Agreement, then, for purposes of this Agreement, while such other Benefit Plans remains in force, the provisions of this Agreement will control and such provision of such other Benefit Plan will be deemed to have been superseded and to be of no force or effect, as if such other agreement had been formally amended to the extent necessary to accomplish such purpose. Nothing in this Agreement prevents or limits the Executive's continuing or future participation in any Benefit Plan provided by the Corporation and nothing in this Agreement limits or otherwise affects the rights the Executive may have under any Benefit Plans with the Corporation. Amounts that are vested benefits or which the Executive is otherwise entitled to receive under any Benefit Plan with the Corporation at or subsequent to the Termination Date will be payable in accordance with such Benefit Plan. 29. Enhanced Severance Benefits. (a) Cash Payment. The Executive will be entitled to a cash payment equal to one and one-half (1.5) times Base Pay (disregarding any change in Base Pay that constitutes Good Reason). The benefit provided under this Paragraph 29(a) will be distributed in a single lump sum within ten business days after the Termination Date or, if later, within ten business days following the effective date of the Change in Control. (b) Continuation of Certain Welfare Benefits. (i) During the period described in Paragraph 29(b)(ii) below, the Corporation will maintain, or continue to reimburse or pay on behalf of the Executive, as the case may be, medical, dental and life insurance plans which by their terms cover the Executive and his family members and dependents under the same terms and at the same cost to the Executive and his family members and dependents as similarly situated executives who continue to be employed by the Corporation (without regard to any reduction in such benefits that constitutes Good Reason). The continuation period under applicable federal and state continuation laws will begin to run from the date on which coverage under this Paragraph ends. (ii) For purposes of Paragraph 29(b)(i) above, the continuation period with respect to any particular plan is the period beginning on the Termination Date and ending on the earlier of: (x) the last day 3 of the twelfth month that begins after the Termination Date, (y) the date after Termination Date on which the Executive first becomes eligible to participate in the plan of another employer providing comparable benefits to the Executive and his eligible family members and dependents which plan does not contain any exclusion or limitation with respect to any pre-existing condition of the Executive or any eligible family member or dependent who would otherwise be covered under the Corporation's plan but for this clause (y), or (z) the date of the Executive's death. (iii) To the extent the Executive incurs a liability for Taxes in connection with a benefit provided pursuant to Paragraph 29(b) which he would not have incurred had he been an active employee of the Corporation participating in one of the Corporation's Benefit Plans, the Corporation shall make a Gross-Up Payment for any such Taxes to the Executive. For purposes of applying the foregoing, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. The payment pursuant to this subparagraph will be made within ten days after the Executive's remittal of a written request therefor, accompanied by a statement indicating the basis for and amount of the liability. (c) Extended Exercise Period for Stock Options. Any stock options issued by the Corporation and held by the Executive shall remain exercisable until thirty-six months following the Termination Date, but in no event beyond the stock option's maximum exercise period (without regard to any provisions that shortens the exercise period in connection with termination of employment or otherwise). 30. Accelerated Vesting and Exercisability. If a Change in Control occurs while the Executive is employed by the Corporation or after the Executive has terminated employment with the Corporation under circumstances entitling him to Enhanced Severance Benefits, (a) all stock options previously granted to the Executive by the Corporation shall become fully vested and exercisable as of the date of the Change in Control, whether or not otherwise exercisable and vested as of that date, and (b) shares of restricted Corporation stock previously awarded to the Executive shall become fully vested. 31. Excise Tax Equalization. The Corporation will cause its independent auditors promptly to review, at the Corporation's sole expense, the applicability of Paragraph 4999 of the Code to any payment or distribution of any type by the Corporation or its Affiliates to or for the benefit of the Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement, any Benefit Plan or otherwise (the "Total Payments"). The Corporation shall engage the auditor so that its review is completed no later than the Change in Control. If the auditor determines that the Total Payments result in an excise tax imposed by Paragraph 4999 of the Code or any comparable state or local law, or any interest or penalties with respect to such excise tax (such excise tax, together with any such interest and penalties, are collectively referred to as the "Excise Tax") and if the Executive is entitled to Enhanced Severance Benefits or accelerated vesting or exercisability of equity compensation under Paragraph 30, or both, the Corporation shall make a Gross-Up Payment for any Excise Taxes to the Executive within ten business days after the Termination Date, but in no event later than the due date for the payments of any excise tax. For purposes of the foregoing determination, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. If any tax authority determines that a greater Excise Tax should be imposed upon the Total Payments than is determined by the Corporation's independent auditors pursuant to this Paragraph 31, the Executive is entitled to receive from the Corporation the full Gross-Up Payment calculated on the basis of the amount of Excise Tax determined to be payable by such tax authority within ten business days after he notifies the Corporation of such determination. 32. Miscellaneous. (a) Successors and Assigns. (i) The Corporation will require any Successor to expressly assume and agree to perform the obligations of this Agreement in the same manner and to the same extent that the Corporation would be required to perform if no such succession had taken place except as specifically required to the contrary hereunder. Failure of the Corporation to obtain such assumption and agreement at least three business days prior to the time a Person becomes a Successor (or where the Corporation does not have at least three business days' advance notice that a Person may become a Successor, within one business day after having notice that such Person may become or has become a Successor) will constitute Good Reason for termination of the Executive's employment. The date on which any such succession becomes effective will be deemed the Termination Date and Notice of Termination will be deemed to have been timely given by the Executive. A Successor has no rights, authority or power with respect to this Agreement prior to a Change in Control. 4 (ii) This Agreement is for the benefit of, and is enforceable by, the Executive, his personal and legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees; provided that, the Executive may not otherwise assign any of his rights or delegate any of his obligations under this Agreement. If the Executive dies after becoming entitled to, but before receiving, any amounts payable under this Agreement, all such amounts, unless otherwise specifically provided to the contrary in this Agreement, will be paid in accordance with the terms of this Agreement to the Executive's devisee, legatee or other designee or, if there be no such designee, to the Executive's estate. (b) No Mitigation or Set-Off. The Executive will not be required to mitigate the amount of any benefits the Corporation becomes obligated to provide in connection with this Agreement by seeking other employment or otherwise. The Corporation has no right to set-off benefits owed under this Agreement against amounts owed or claimed to be owed by the Executive to the Corporation under this Agreement or otherwise. (c) Taxes. All benefits to be provided to the Executive in connection with the this Agreement will be subject to required withholding of federal, state and local income, excise and employment-related taxes. (d) Survival. The respective obligations of, and benefits afforded to, the Corporation and the Executive which, by their express terms or clear meaning, survive termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be, will remain in full force and effect according to their terms notwithstanding the termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be. (e) Benefits as Eligible Compensation under Other Benefit Plans. Unless otherwise expressly provided therein, benefits paid or payable under this Agreement will not be deemed to be salary or compensation for purposes of determining the benefits to which the Executive may be entitled under any other Benefit Plan sponsored, maintained or contributed to by the Corporation." 21. Except as amended as set forth in this First Amendment, the Employment Agreement shall remain in full force and effect in accordance with its terms. IN WITNESS WHEREOF, this First Amendment has been executed by the Corporation, by its duly authorized representative, and by Executive, as of the Effective Date. EXECUTIVE CORPORATION /s/ Thomas A. Armer /s/ Loren G. Peterson - ------------------------------ ----------------------------- By: Loren G. Peterson Title: President and CEO 5 APPENDIX A DEFINITIONS Whenever the following capitalized terms are used in the Agreement, they shall have the meaning specified below. Affiliate "Affiliate" shall mean: (a) any corporation at least a majority of whose outstanding securities ordinarily having the right to vote at elections of directors is owned directly or indirectly by the Corporation; or (b) any other form of business entity in which the Corporation, by virtue of a direct or indirect ownership interest, has the right to elect a majority of the members of such entity's governing body. Base Pay "Base Pay" shall mean the Executive's base salary at the highest annual rate in effect immediately prior to the Change in Control or at the time Notice of Termination is given, whichever is greater, disregarding any decrease which constitutes Good Reason for the Executive's termination of employment. Base Pay includes only regular cash salary and wages and is determined before any reduction for deferrals pursuant to any nonqualified deferred compensation plan or arrangement, qualified cash or deferred arrangement or cafeteria plan. Beneficial Owner "Beneficial Owner" shall have the meaning ascribed to such term in Rule 13d-3 of the General Rules and Regulations under the Exchange Act. Benefit Plan "Benefit Plan" is (a) employee benefit plan as defined in Paragraph 3(3) of ERISA, (b) a cafeteria plan described in Paragraph 125 of the Code, (c) a plan, policy or practice providing for paid vacation, other paid time off or short- or long-term profit sharing, bonus or incentive payments, or (d) stock option, stock purchase, restricted stock, phantom stock, stock appreciation right or other equity-based compensation plan that is sponsored, maintained or contributed to by the Corporation or its Affiliates for the benefit of employees (and/or their families and dependents) generally or the Executive (and/or the Executive's family and dependents) in particular. Board "Board" is the board of directors of the Corporation duly qualified and acting at the time in question. On and after the date of a Change in Control, any duty of the Board in connection with this Agreement is non-delegable and any attempt by the Board to delegate any such duty is ineffective. Change in Control A "Change in Control" shall mean the first of the following events to occur: (a) Any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing at least thirty percent or, in the case of Elan Corporation and its Affiliates in the aggregate (collectively, the "Elan Group"), at least fifty percent, of the combined voting power of the Corporation's then outstanding securities; (b) During any twenty-four month consecutive period beginning on or after October 1, 2001, individuals who at the beginning of such period constituted a majority of the Board of Directors cease for any reason during any day during any such period to constitute a majority thereof; provided, however, that any director who is not in office at the beginning of such twenty-four month period, but whose election by the Board or whose nomination for election by the Company's shareholders was to fill a vacancy caused by death or retirement and was 6 approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of such period or whose election or nomination for election was previously so approved shall be deemed to have been in office at the beginning of such period for purposes of this definition; (c) the stockholders of the Corporation approve a merger or consolidation of the Corporation with any other Corporation or agreement of exchange involving the Corporation ("Merger"), other than (1) a Merger which would result in the voting securities of the Corporation outstanding as of October 1, 2001 continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent of the combined voting power of the voting securities of the Corporation or such surviving entity outstanding immediately after the Merger, or (2) a Merger effected to implement a recapitalization of the Corporation (or similar transaction) in which no Person acquires thirty percent or more, or in the case of Elan Group in the aggregate, fifty percent or more, of the combined voting power of the Corporation's then outstanding securities; or (d) the stockholders of the Corporation approve a plan of complete liquidation of the Corporation or an agreement for the sale, lease, exchange or other transfer (in one transaction or a series of related transactions) or disposition by the Corporation of all or substantially all of the Corporation's assets. Code "Code" shall mean the Internal Revenue Code of 1986, as amended. Any reference to a specific provision of the Code includes a reference to such provision as it may be amended from time to time and to any successor provision. Effective Date "Effective Date" shall mean the Effective Date of the First Amendment. ERISA "ERISA" shall mean the Employee Retirement Income Security Act of 1974, as amended. Any reference to a specific provision of ERISA includes a reference to such provision as it may be amended from time to time and to any successor provision. Exchange Act The "Exchange Act" shall mean the Securities Exchange Act of 1934, as amended. Any reference to a specific provision of the Exchange Act or to any rule or regulation thereunder includes a reference to such provision as it may be amended from time to time and to any successor provision. Good Reason "Good Reason" shall mean the occurrence of one or more of the following events (regardless of whether any other reason, other than Cause, for such termination exists or has occurred, including without limitation other employment): (a) failure to elect or reelect or otherwise maintain the Executive in the offices or positions that the Executive held immediately prior to the Change in Control; (b) a change in the nature or scope of the authorities, powers, functions, duties or responsibilities attached to the position with the Corporation that the Executive held immediately prior to the Change in Control, as reasonably determined by the Executive; (c) a reduction by the Corporation in the Executive's Base Pay or an adverse change in the form or timing of the payment thereof, as in effect immediately prior to the Potential Change in Control or as thereafter increased; 7 (d) the failure by the Corporation to cover the Executive under Benefit Plans that, in the aggregate, provide substantially similar benefits to the Executive and/or his family and dependents at a substantially similar total cost to the Executive (e.g., premiums, deductibles, co-pays, out of pocket maximums, required contributions, Taxes and the like) relative to the highest benefits and lowest total costs under the Benefit Plans in which the Executive (and/or his family or dependents) is participating at any time during the period between the Potential Change in Control and the Change in Control; (e) the Corporation's requiring the Executive to be based more than fifty miles from where his office is located immediately prior to the Change in Control, except for required travel on the Corporation's business, and then only to the extent substantially consistent with the business travel obligations which the Executive undertook on behalf of the Corporation during the ninety day period ending on the date of the Potential Change in Control (without regard to travel related to or in anticipation of the Change in Control); (f) the failure of the Corporation to obtain from any Successor the assent to this Agreement as required under Paragraph 32(a)(i); (g) any purported termination by the Corporation of the Executive's employment which is not properly effected pursuant to a Notice of Termination and pursuant to any other requirements of this Agreement and, for purposes of this Agreement, no such purported termination will be effective; or (h) any refusal by the Corporation to continue to allow the Executive to attend to matters or engage in activities not directly related to the business of the Corporation which, at any time prior to the Potential Change in Control, the Executive was not expressly prohibited by the Corporation from attending to or engaging in. The Executive's continued employment does not constitute consent to, or waiver of any rights arising in connection with, any circumstance constituting Good Reason. Notwithstanding the foregoing, the occurrence of an event that would otherwise constitute Good Reason hereunder shall cease to be an event constituting Good Reason if the Executive does not provide a Notice of Termination to the Corporation within one hundred eighty days of the date that the Executive first becomes aware of the occurrence of such event. Termination by the Executive of his employment for Good Reason as defined hereunder will constitute Good Reason for all purposes of this Agreement, even if the Executive may also thereby be deemed to have "retired" under any applicable retirement programs of the Corporation. Gross-Up Payment "Gross-Up Payment" shall mean an amount payable to the Executive such that, after the payment of all Taxes attributable to any item of compensation subject to gross-up under this Agreement by the Corporation, there remains a balance sufficient to pay the Taxes being reimbursed. Person A "Person" shall mean any individual, corporation, partnership, group, association or other "person," as such term is used in Paragraph 14(d) of the Exchange Act, other than the Corporation, any Affiliate or any benefit plan sponsored by the Corporation or an Affiliate. 8 Potential Change in Control A "Potential Change in Control" shall be the first of the following events to occur: (a) the Corporation enters into an agreement, the consummation of which would result in the occurrence of a Change in Control; (b) any Person (including the Corporation) publicly announces an intention to take or to consider taking actions which, if consummated, would constitute a Change in Control; or (c) any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing fifteen percent or more of the combined voting power of the Corporation's then outstanding securities, increases its beneficial ownership of such securities by one percentage point or more over the percentage so owned by such Person on the Effective Date, other than an increase in ownership percentage due to the payment of dividends by the issuance of additional securities of the Corporation; or (d) the Board adopts a resolution to the effect that, for purposes of this Agreement, a Potential Change in Control has occurred. The Board shall not be precluded from adopting a resolution to the effect that, for purposes of this Agreement, it is the good faith opinion of the Board that a Potential Change in Control has been abandoned and that a Potential Change in Control no longer exists. An event shall not be a Potential Change in Control for purposes of this Agreement if a Change in Control does not occur within twelve months of such event. Successor A "Successor" shall mean any Person that succeeds to, or has the practical ability to control (either immediately or solely with the passage of time), the Corporation's business directly, by merger, consolidation or other form of business combination, or indirectly, by purchase of the Corporation's outstanding securities ordinarily having the right to vote at the election of directors, all or substantially all of its assets or otherwise. Taxes "Taxes" shall mean the incremental federal, state and local income, excise and other taxes (including Excise Taxes), penalties and interest payable by the Executive with respect to any applicable item of income. Termination Date "Termination Date" shall mean: (1) in the case of an employment termination by the Corporation for Cause or by the Executive for Good Reason, the date specified as the Executive's last day of employment in the Notice of Termination, which shall not be less than ten business days after the date such Notice of Termination is deemed given in accordance with Paragraph 18, or (2) in any other case, the last day worked by the Executive as reflected on the Corporation's payroll records. Notwithstanding the foregoing, if the Corporation terminates the Executive's employment for Cause and the Executive has not previously expressly agreed in writing to the termination, then within the thirty day period after the Executive's receipt of the Notice of Termination, the Executive may notify the Corporation that a dispute exists concerning the termination, in which event the Termination Date will be the date set either by mutual written agreement of the parties or by the arbitrators or a court under the dispute resolution provisions in Paragraph 26. During the pendency of any such dispute, the Executive will continue to make himself available to provide services to the Corporation and the Corporation will continue to pay the Executive his full compensation and benefits in effect immediately prior to the date on which the Notice of Termination is given (without regard to any changes to such compensation or benefits which constitute Good Reason) and until the dispute is resolved in accordance with Paragraph 26. The Executive will be entitled to retain the full amount of any such compensation and benefits without regard to the resolution of the dispute unless the arbitrators or judge decide(s) that the Executive's claim of a dispute was frivolous or advanced by the Executive in bad faith. 9 EX-10.13A 7 c68433ex10-13a.txt AMENDMENT TO EMPLOYMENT AGREEMENT EXHIBIT 10.13A THIS FIRST AMENDMENT TO EMPLOYMENT AGREEMENT ("First Amendment") is made this first day of October, 2001 (the "Effective Date"), by and between Sheffield Pharmaceuticals, Inc. (the "Corporation") and Loren G. Peterson (the "Executive"). WHEREAS, the Compensation Committee of the Board of Directors has determined that a possibility of a Change in Control of the Corporation exists and appropriate steps should be taken to reinforce and encourage the continued attention and dedication of certain management to their assigned duties. NOW, THEREFORE, in consideration of the covenants and agreements contained herein, intending to be legally bound, the Corporation and Executive hereby agree, effective as of the Effective Date, as follows: 22. Paragraph 3 of the Employment Agreement by and between the Corporation and Executive dated April 25, 1997 (the "Employment Agreement") is hereby amended by deleting the fourth sentence in its entirety and adding to the third sentence the following: "; provided that, no such notice by the Corporation shall be effective and the term of this Agreement shall be extended for an additional year if a Potential Change in Control shall have occurred or occurs at any time prior to the date of such notice or within the twelve month period beginning on the date of such notice. Further, if a Change in Control shall have occurred at any time during the term of this Agreement, then notwithstanding any provision hereof to the contrary, the term shall continue in effect for: (i) the remainder of the month in which the Change in Control occurred, and (ii) a term of twenty-four months beyond the month in which such Change in Control occurred; provided that, if any obligations of the Corporation hereunder shall not have been fully and finally discharged at the end of such twenty-four month period, the term shall continue until such obligations shall have been finally discharged in full. The period commencing on the earlier of a Potential Change in Control (if applicable) or Change in Control and ending with the conclusion of such twenty-four month period shall be referred to hereinafter as the "Protection Period." 23. Paragraph 12(c) of the Employment Agreement is hereby deleted in its entirety. 24. Paragraph 14 of the Employment Agreement is hereby amended by deleting Paragraph 14 in its entirety and replacing it with the following: "14. Termination for Cause. The Corporation may at any time upon written notice to Executive terminate Executive's employment for Cause. For purposes of this Agreement, the following shall constitute Cause: (a) the Executive's gross misconduct which is materially and demonstrably injurious to the Corporation; (b) the Executive's willful and continued failure to perform substantially his duties with the Corporation (other than a failure resulting from the Executive's incapacity due to bodily injury or physical or mental illness) after a demand for substantial performance is delivered to the Executive by the Board which specifically identifies the manner in which the Board believes that the Executive has not substantially performed his duties and provides for a reasonable period of time within which the Executive may take corrective measures; or (c) the Executive's conviction (including a plea of nolo contendere) of willfully engaging in illegal conduct constituting a felony or a gross misdemeanor involving an intentional act of fraud, misrepresentation, theft, embezzlement or dishonesty under federal or state law (or comparable illegal conduct under the laws of any foreign jurisdiction) which is materially and demonstrably injurious to the Corporation or which impairs the Executive's ability to perform substantially his duties with the Corporation. An act or failure to act will be considered "gross" or "willful" for this purpose only if done, or omitted to be done, by the Executive in bad faith and without reasonable belief that it was in, or not opposed to, the best interests of the Corporation. Any act, or failure to act, based upon authority given pursuant to a resolution duly adopted by the Board or governing body of the Corporation (or a committee thereof) or based upon the advice of counsel for the Corporation will be conclusively presumed to be done, or omitted to be done, by the Executive in good faith and in the best interests of the Corporation. Executive's attention to matters not directly related to the business of the Corporation will not provide a basis for termination for Cause so long as the Board did not expressly disapprove in writing of his engagement in such activities either before or within a reasonable period of time after the Board knew or could reasonably have known that the Executive engaged in those activities. Notwithstanding the 1 foregoing, the Executive may not be terminated for Cause unless and until there has been delivered to Executive a copy of a resolution duly adopted by the affirmative vote of not less than two-thirds of the entire membership of the Board (excluding such Executive) at a meeting of the Board called and held for such purpose (after reasonable notice to such Executive and an opportunity for such Executive, together with his counsel, to be heard before the Board), finding that in the good faith opinion of the Board such Executive engaged in the conduct set forth in paragraphs (a), (b) or (c) above and specifying the particulars thereof in detail." 25. Paragraph 21 of the Employment Agreement is hereby amended by adding to the end of the first sentence the following: "and the Corporation hereby irrevocably consents to the jurisdiction of the federal and state courts sitting in the State of Missouri for purposes of enforcing this Agreement." 26. Paragraph 26 of the Employment Agreement is hereby amended by deleting Paragraph 26 in its entirety and replacing it with the following: "26. Disputes. (a) If the Executive so elects, any dispute, controversy or claim arising under or in connection with this Agreement will be settled exclusively by binding arbitration in St. Louis, Missouri in accordance with the Employee Benefit Plan Claims Arbitration Rules of the American Arbitration Association, incorporated by referenced herein. Judgment may be entered on the arbitrator's award in any court having jurisdiction; provided that, the Executive may seek specific performance of his right to receive benefits until the Termination Date during the pendency of any dispute or controversy arising under or in connection with this Agreement. (b) If the Executive does not elect arbitration to resolve a dispute, claim or controversy, he may pursue all other available legal remedies. (c) Any review by an arbitrator or a court of competent jurisdiction of a decision made by the Board at any time after a Change in Control shall be de novo, and any such Board determination shall not be entitled to deference. (d) The Corporation will not assert in any dispute or controversy with the Executive arising under or in connection with this Agreement the Executive's failure to exhaust administrative remedies. (e) In the event of any dispute, claim or controversy arising out of or in connection with this Agreement, if the Executive prevails on any of the material issues involved in any such dispute, claim or controversy, the Corporation shall pay to the Executive immediately upon demand all reasonable expenses (including without limitation attorneys' fees) incurred by the Executive in connection therewith. (f) If the Corporation refuses or otherwise fails to make a payment when due under this Agreement and it is ultimately determined that the Executive is entitled to such payment, such payment shall be increased to reflect an interest factor, compounded annually, equal to the prime rate in effect as of the date the payment was first due plus five points. For this purpose, the prime rate shall be based on the rate identified by Chase Manhattan Bank as its prime rate in New York City." 27. The Employment Agreement is further amended by adding the following as new Paragraphs 27 through 32: "27. Definitions. For purposes of this Agreement, the capitalized terms set forth herein and not otherwise defined shall have the meanings set forth in Appendix A attached hereto which shall have the same force and effect as if included as a Paragraph in this Amendment and shall apply when interpreting the terms of this Agreement. 28. Termination Employment in Connection with a Change in Control. (a) Eligibility. If the Executive's employment is terminated during the Protection Period either: (i) by the Corporation without Cause, or (ii) by the Executive for Good Reason, the Corporation will provide 2 the Executive with the payments and benefits set forth in Paragraph 29 below (collectively, the "Enhanced Severance Benefits"), accelerated vesting and exercisability of stock based compensation under Paragraph 30 and a Gross-Up Payment for "Excise Tax" (as defined in Paragraph 31) under Paragraph 31. If the Executive terminates employment with the Corporation under any other circumstances, he shall not be entitled to Enhanced Severance Benefits under Paragraph 29, but may be entitled to (c) benefits under Paragraph 12 hereunder, and (d) accelerated vesting and exercisability of stock based compensation under Paragraph 30 and a Gross-Up Payment for Excise Tax under Paragraph 31 by remaining employed with the Corporation as of a Change in Control. In no event shall Executive be entitled to Enhanced Severance Benefits under Paragraph 29 and to benefits under Paragraph 12. (b) Process for Termination of Employment. During the Protection Period, any termination of the Executive's employment by the Executive for Good Reason or by the Corporation for Cause shall be communicated by written Notice of Termination from the party terminating employment hereunder to the other party hereto in accordance with Paragraph 18. A "Notice of Termination" shall mean, for purposes of this Agreement, a written notice given in good faith and with a reasonable belief that Good Reason or Cause, as the case may be, has occurred, which shall indicate the specific termination provision in this Agreement relied upon and shall set forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive's employment under the provision so indicated. Any Notice of Termination must specify a Termination Date and any Notice of Termination for Cause shall include a copy of the relevant resolution of the Board action taken in accordance with the terms of this Agreement to terminate the Executive's employment for Cause. (c) Compensation and Benefits before Termination Date. During the period beginning on the date the Executive or the Corporation, as the case may be, receives Notice of Termination and ending on the Termination Date, the Corporation will continue to pay the Executive his Base Pay and cause his continued participation in all Benefit Plans in accordance with the terms of such Benefit Plans. (d) Rights Under Other Plans, Policies, Practices and Agreements. Other than to the extent expressly provided herein, this Agreement does not supersede any other plans, policies, and/or practices of the Corporation. To the extent that any provision of any Benefit Plan limits, qualifies or is inconsistent with any of the benefits provided under this Agreement, then, for purposes of this Agreement, while such other Benefit Plans remains in force, the provisions of this Agreement will control and such provision of such other Benefit Plan will be deemed to have been superseded and to be of no force or effect, as if such other agreement had been formally amended to the extent necessary to accomplish such purpose. Nothing in this Agreement prevents or limits the Executive's continuing or future participation in any Benefit Plan provided by the Corporation and nothing in this Agreement limits or otherwise affects the rights the Executive may have under any Benefit Plans with the Corporation. Amounts that are vested benefits or which the Executive is otherwise entitled to receive under any Benefit Plan with the Corporation at or subsequent to the Termination Date will be payable in accordance with such Benefit Plan. 29. Enhanced Severance Benefits. (a) Cash Payment. The Executive will be entitled to a cash payment equal to two (2) times Base Pay (disregarding any change in Base Pay that constitutes Good Reason). The benefit provided under this Paragraph 29(a) will be distributed in a single lump sum within ten business days after the Termination Date or, if later, within ten business days following the effective date of the Change in Control. (b) Continuation of Certain Welfare Benefits. (i) During the period described in Paragraph 29(b)(ii) below, the Corporation will maintain, or continue to reimburse or pay on behalf of the Executive, as the case may be, medical, dental and life insurance plans which by their terms cover the Executive and his family members and dependents under the same terms and at the same cost to the Executive and his family members and dependents as similarly situated executives who continue to be employed by the Corporation (without regard to any reduction in such benefits that constitutes Good Reason). The continuation period under applicable federal and state continuation laws will begin to run from the date on which coverage under this Paragraph ends. (ii) For purposes of Paragraph 29(b)(i) above, the continuation period with respect to any particular plan is the period beginning on the Termination Date and ending on the earlier of: (x) the last day 3 of the twelfth month that begins after the Termination Date, (y) the date after Termination Date on which the Executive first becomes eligible to participate in the plan of another employer providing comparable benefits to the Executive and his eligible family members and dependents which plan does not contain any exclusion or limitation with respect to any pre-existing condition of the Executive or any eligible family member or dependent who would otherwise be covered under the Corporation's plan but for this clause (y), or (z) the date of the Executive's death. (iii) To the extent the Executive incurs a liability for Taxes in connection with a benefit provided pursuant to Paragraph 29(b) which he would not have incurred had he been an active employee of the Corporation participating in one of the Corporation's Benefit Plans, the Corporation shall make a Gross-Up Payment for any such Taxes to the Executive. For purposes of applying the foregoing, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. The payment pursuant to this subparagraph will be made within ten days after the Executive's remittal of a written request therefor, accompanied by a statement indicating the basis for and amount of the liability. (c) Extended Exercise Period for Stock Options. Any stock options issued by the Corporation and held by the Executive shall remain exercisable until thirty-six months following the Termination Date, but in no event beyond the stock option's maximum exercise period (without regard to any provisions that shortens the exercise period in connection with termination of employment or otherwise). 30. Accelerated Vesting and Exercisability. If a Change in Control occurs while the Executive is employed by the Corporation or after the Executive has terminated employment with the Corporation under circumstances entitling him to Enhanced Severance Benefits, (a) all stock options previously granted to the Executive by the Corporation shall become fully vested and exercisable as of the date of the Change in Control, whether or not otherwise exercisable and vested as of that date, and (b) shares of restricted Corporation stock previously awarded to the Executive shall become fully vested. 31. Excise Tax Equalization. The Corporation will cause its independent auditors promptly to review, at the Corporation's sole expense, the applicability of Paragraph 4999 of the Code to any payment or distribution of any type by the Corporation or its Affiliates to or for the benefit of the Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement, any Benefit Plan or otherwise (the "Total Payments"). The Corporation shall engage the auditor so that its review is completed no later than the Change in Control. If the auditor determines that the Total Payments result in an excise tax imposed by Paragraph 4999 of the Code or any comparable state or local law, or any interest or penalties with respect to such excise tax (such excise tax, together with any such interest and penalties, are collectively referred to as the "Excise Tax") and if the Executive is entitled to Enhanced Severance Benefits or accelerated vesting or exercisability of equity compensation under Paragraph 30, or both, the Corporation shall make a Gross-Up Payment for any Excise Taxes to the Executive within ten business days after the Termination Date, but in no event later than the due date for the payments of any excise tax. For purposes of the foregoing determination, the Executive's tax rate will be deemed to be the highest statutory marginal state and federal tax rate (on a combined basis) then in effect. If any tax authority determines that a greater Excise Tax should be imposed upon the Total Payments than is determined by the Corporation's independent auditors pursuant to this Paragraph 31, the Executive is entitled to receive from the Corporation the full Gross-Up Payment calculated on the basis of the amount of Excise Tax determined to be payable by such tax authority within ten business days after he notifies the Corporation of such determination. 32. Miscellaneous. (a) Successors and Assigns. (i) The Corporation will require any Successor to expressly assume and agree to perform the obligations of this Agreement in the same manner and to the same extent that the Corporation would be required to perform if no such succession had taken place except as specifically required to the contrary hereunder. Failure of the Corporation to obtain such assumption and agreement at least three business days prior to the time a Person becomes a Successor (or where the Corporation does not have at least three business days' advance notice that a Person may become a Successor, within one business day after having notice that such Person may become or has become a Successor) will constitute Good Reason for termination of the Executive's employment. The date on which any such succession becomes effective will be deemed the Termination Date and Notice of Termination will be deemed to have been timely given by the Executive. A Successor has no rights, authority or power with respect to this Agreement prior to a Change in Control. 4 (ii) This Agreement is for the benefit of, and is enforceable by, the Executive, his personal and legal representatives, executors, administrators, successors, heirs, distributees, devisees and legatees; provided that, the Executive may not otherwise assign any of his rights or delegate any of his obligations under this Agreement. If the Executive dies after becoming entitled to, but before receiving, any amounts payable under this Agreement, all such amounts, unless otherwise specifically provided to the contrary in this Agreement, will be paid in accordance with the terms of this Agreement to the Executive's devisee, legatee or other designee or, if there be no such designee, to the Executive's estate. (b) No Mitigation or Set-Off. The Executive will not be required to mitigate the amount of any benefits the Corporation becomes obligated to provide in connection with this Agreement by seeking other employment or otherwise. The Corporation has no right to set-off benefits owed under this Agreement against amounts owed or claimed to be owed by the Executive to the Corporation under this Agreement or otherwise. (c) Taxes. All benefits to be provided to the Executive in connection with the this Agreement will be subject to required withholding of federal, state and local income, excise and employment-related taxes. (d) Survival. The respective obligations of, and benefits afforded to, the Corporation and the Executive which, by their express terms or clear meaning, survive termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be, will remain in full force and effect according to their terms notwithstanding the termination of the Executive's employment with the Corporation or termination of this Agreement, as the case may be. (e) Benefits as Eligible Compensation under Other Benefit Plans. Unless otherwise expressly provided therein, benefits paid or payable under this Agreement will not be deemed to be salary or compensation for purposes of determining the benefits to which the Executive may be entitled under any other Benefit Plan sponsored, maintained or contributed to by the Corporation." 28. Except as amended as set forth in this First Amendment, the Employment Agreement shall remain in full force and effect in accordance with its terms. IN WITNESS WHEREOF, this First Amendment has been executed by the Corporation, by its duly authorized representative, and by Executive, as of the Effective Date. EXECUTIVE CORPORATION /s/ Loren G. Peterson /s/ Thomas M. Fitzgerald - ------------------------------ ----------------------------- By: Thomas M. Fitzgerald Title: Chairman 5 APPENDIX A DEFINITIONS Whenever the following capitalized terms are used in the Agreement, they shall have the meaning specified below. Affiliate "Affiliate" shall mean: (a) any corporation at least a majority of whose outstanding securities ordinarily having the right to vote at elections of directors is owned directly or indirectly by the Corporation; or (b) any other form of business entity in which the Corporation, by virtue of a direct or indirect ownership interest, has the right to elect a majority of the members of such entity's governing body. Base Pay "Base Pay" shall mean the Executive's base salary at the highest annual rate in effect immediately prior to the Change in Control or at the time Notice of Termination is given, whichever is greater, disregarding any decrease which constitutes Good Reason for the Executive's termination of employment. Base Pay includes only regular cash salary and wages and is determined before any reduction for deferrals pursuant to any nonqualified deferred compensation plan or arrangement, qualified cash or deferred arrangement or cafeteria plan. Beneficial Owner "Beneficial Owner" shall have the meaning ascribed to such term in Rule 13d-3 of the General Rules and Regulations under the Exchange Act. Benefit Plan "Benefit Plan" is (a) employee benefit plan as defined in Paragraph 3(3) of ERISA, (b) a cafeteria plan described in Paragraph 125 of the Code, (c) a plan, policy or practice providing for paid vacation, other paid time off or short- or long-term profit sharing, bonus or incentive payments, or (d) stock option, stock purchase, restricted stock, phantom stock, stock appreciation right or other equity-based compensation plan that is sponsored, maintained or contributed to by the Corporation or its Affiliates for the benefit of employees (and/or their families and dependents) generally or the Executive (and/or the Executive's family and dependents) in particular. Board "Board" is the board of directors of the Corporation duly qualified and acting at the time in question. On and after the date of a Change in Control, any duty of the Board in connection with this Agreement is non-delegable and any attempt by the Board to delegate any such duty is ineffective. Change in Control A "Change in Control" shall mean the first of the following events to occur: (a) Any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing at least thirty percent or, in the case of Elan Corporation and its Affiliates in the aggregate (collectively, the "Elan Group"), at least fifty percent, of the combined voting power of the Corporation's then outstanding securities; (b) During any twenty-four month consecutive period beginning on or after October 1, 2001, individuals who at the beginning of such period constituted a majority of the Board of Directors cease for any reason during any day during any such period to constitute a majority thereof; provided, however, that any director who is not in office at the beginning of such twenty-four month period, but whose election by the Board or whose nomination for election by the Company's shareholders was to fill a vacancy caused by death or retirement and was 6 approved by a vote of at least two-thirds of the directors then still in office who either were directors at the beginning of such period or whose election or nomination for election was previously so approved shall be deemed to have been in office at the beginning of such period for purposes of this definition; (c) the stockholders of the Corporation approve a merger or consolidation of the Corporation with any other Corporation or agreement of exchange involving the Corporation ("Merger"), other than (1) a Merger which would result in the voting securities of the Corporation outstanding as of October 1, 2001 continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent of the combined voting power of the voting securities of the Corporation or such surviving entity outstanding immediately after the Merger, or (2) a Merger effected to implement a recapitalization of the Corporation (or similar transaction) in which no Person acquires thirty percent or more, or in the case of Elan Group in the aggregate, fifty percent or more, of the combined voting power of the Corporation's then outstanding securities; or (d) the stockholders of the Corporation approve a plan of complete liquidation of the Corporation or an agreement for the sale, lease, exchange or other transfer (in one transaction or a series of related transactions) or disposition by the Corporation of all or substantially all of the Corporation's assets. Code "Code" shall mean the Internal Revenue Code of 1986, as amended. Any reference to a specific provision of the Code includes a reference to such provision as it may be amended from time to time and to any successor provision. Effective Date "Effective Date" shall mean the Effective Date of the First Amendment. ERISA "ERISA" shall mean the Employee Retirement Income Security Act of 1974, as amended. Any reference to a specific provision of ERISA includes a reference to such provision as it may be amended from time to time and to any successor provision. Exchange Act The "Exchange Act" shall mean the Securities Exchange Act of 1934, as amended. Any reference to a specific provision of the Exchange Act or to any rule or regulation thereunder includes a reference to such provision as it may be amended from time to time and to any successor provision. Good Reason "Good Reason" shall mean the occurrence of one or more of the following events (regardless of whether any other reason, other than Cause, for such termination exists or has occurred, including without limitation other employment): (a) failure to elect or reelect or otherwise maintain the Executive in the offices or positions that the Executive held immediately prior to the Change in Control; (b) a change in the nature or scope of the authorities, powers, functions, duties or responsibilities attached to the position with the Corporation that the Executive held immediately prior to the Change in Control, as reasonably determined by the Executive; (c) a reduction by the Corporation in the Executive's Base Pay or an adverse change in the form or timing of the payment thereof, as in effect immediately prior to the Potential Change in Control or as thereafter increased; 7 (d) the failure by the Corporation to cover the Executive under Benefit Plans that, in the aggregate, provide substantially similar benefits to the Executive and/or his family and dependents at a substantially similar total cost to the Executive (e.g., premiums, deductibles, co-pays, out of pocket maximums, required contributions, Taxes and the like) relative to the highest benefits and lowest total costs under the Benefit Plans in which the Executive (and/or his family or dependents) is participating at any time during the period between the Potential Change in Control and the Change in Control; (e) the Corporation's requiring the Executive to be based more than fifty miles from where his office is located immediately prior to the Change in Control, except for required travel on the Corporation's business, and then only to the extent substantially consistent with the business travel obligations which the Executive undertook on behalf of the Corporation during the ninety day period ending on the date of the Potential Change in Control (without regard to travel related to or in anticipation of the Change in Control); (f) the failure of the Corporation to obtain from any Successor the assent to this Agreement as required under Paragraph 32(a)(i); (g) any purported termination by the Corporation of the Executive's employment which is not properly effected pursuant to a Notice of Termination and pursuant to any other requirements of this Agreement and, for purposes of this Agreement, no such purported termination will be effective; or (h) any refusal by the Corporation to continue to allow the Executive to attend to matters or engage in activities not directly related to the business of the Corporation which, at any time prior to the Potential Change in Control, the Executive was not expressly prohibited by the Corporation from attending to or engaging in. The Executive's continued employment does not constitute consent to, or waiver of any rights arising in connection with, any circumstance constituting Good Reason. Notwithstanding the foregoing, the occurrence of an event that would otherwise constitute Good Reason hereunder shall cease to be an event constituting Good Reason if the Executive does not provide a Notice of Termination to the Corporation within one hundred eighty days of the date that the Executive first becomes aware of the occurrence of such event. Termination by the Executive of his employment for Good Reason as defined hereunder will constitute Good Reason for all purposes of this Agreement, even if the Executive may also thereby be deemed to have "retired" under any applicable retirement programs of the Corporation. Gross-Up Payment "Gross-Up Payment" shall mean an amount payable to the Executive such that, after the payment of all Taxes attributable to any item of compensation subject to gross-up under this Agreement by the Corporation, there remains a balance sufficient to pay the Taxes being reimbursed. Person A "Person" shall mean any individual, corporation, partnership, group, association or other "person," as such term is used in Paragraph 14(d) of the Exchange Act, other than the Corporation, any Affiliate or any benefit plan sponsored by the Corporation or an Affiliate. Potential Change in Control A "Potential Change in Control" shall be the first of the following events to occur: (a) the Corporation enters into an agreement, the consummation of which would result in the occurrence of a Change in Control; (b) any Person (including the Corporation) publicly announces an intention to take or to consider taking actions which, if consummated, would constitute a Change in Control; or (c) any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Corporation representing fifteen percent or more of the combined voting power of the Corporation's then outstanding 8 securities, increases its beneficial ownership of such securities by one percentage point or more over the percentage so owned by such Person on the Effective Date, other than an increase in ownership percentage due to the payment of dividends by the issuance of additional securities of the Corporation; or (d) the Board adopts a resolution to the effect that, for purposes of this Agreement, a Potential Change in Control has occurred. The Board shall not be precluded from adopting a resolution to the effect that, for purposes of this Agreement, it is the good faith opinion of the Board that a Potential Change in Control has been abandoned and that a Potential Change in Control no longer exists. An event shall not be a Potential Change in Control for purposes of this Agreement if a Change in Control does not occur within twelve months of such event. Successor A "Successor" shall mean any Person that succeeds to, or has the practical ability to control (either immediately or solely with the passage of time), the Corporation's business directly, by merger, consolidation or other form of business combination, or indirectly, by purchase of the Corporation's outstanding securities ordinarily having the right to vote at the election of directors, all or substantially all of its assets or otherwise. Taxes "Taxes" shall mean the incremental federal, state and local income, excise and other taxes (including Excise Taxes), penalties and interest payable by the Executive with respect to any applicable item of income. Termination Date "Termination Date" shall mean: (1) in the case of an employment termination by the Corporation for Cause or by the Executive for Good Reason, the date specified as the Executive's last day of employment in the Notice of Termination, which shall not be less than ten business days after the date such Notice of Termination is deemed given in accordance with Paragraph 18, or (2) in any other case, the last day worked by the Executive as reflected on the Corporation's payroll records. Notwithstanding the foregoing, if the Corporation terminates the Executive's employment for Cause and the Executive has not previously expressly agreed in writing to the termination, then within the thirty day period after the Executive's receipt of the Notice of Termination, the Executive may notify the Corporation that a dispute exists concerning the termination, in which event the Termination Date will be the date set either by mutual written agreement of the parties or by the arbitrators or a court under the dispute resolution provisions in Paragraph 26. During the pendency of any such dispute, the Executive will continue to make himself available to provide services to the Corporation and the Corporation will continue to pay the Executive his full compensation and benefits in effect immediately prior to the date on which the Notice of Termination is given (without regard to any changes to such compensation or benefits which constitute Good Reason) and until the dispute is resolved in accordance with Paragraph 26. The Executive will be entitled to retain the full amount of any such compensation and benefits without regard to the resolution of the dispute unless the arbitrators or judge decide(s) that the Executive's claim of a dispute was frivolous or advanced by the Executive in bad faith. 9 EX-10.37 8 c68433ex10-37.txt SEPARATION AGREEMENT EXHIBIT 10.37 February 18, 2002 Mr. Carl F. Siekmann 15915 Wetherburn Road Chesterfield, Missouri 63017 Dear Carl: This letter follows up on the discussions we have had recently concerning the mutually agreeable separation of your employment for reasons other than cause with Sheffield Pharmaceuticals, Inc. (the "Company"). To assist you in your transition, the Company is offering to you certain severance and other benefits in exchange for the general release of claims and other terms set forth below. The specific terms of the Company's proposed agreement (the "Agreement") are as follows: 1. TERMINATION OF EMPLOYMENT. The effective date of your termination shall be February 15, 2002 (the "Termination Date"). The Company will pay you all wages earned and any accrued and unused vacation time in accordance with Company policy through your Termination Date. For the period from the date of this letter through your Termination Date, you will continue to perform your duties and responsibilities in your current position; provided however that the Company may at any time and in its sole discretion request that you vacate the Company's premises and cease performing any duties for the Company. In such event, the Company shall remain obligated to pay to you all wages due to you through your Termination Date. 2. SEVERANCE PAY. The Company will continue to pay your base salary, as in effect on your Termination Date, for a period of nine months following your Termination Date, subject to appropriate tax withholdings and authorized deductions, in accordance with the Company's regular payroll practices and regular pay schedule. 3. BENEFIT CONTINUATION. (a) Death and Disability Insurance. The Company will continue to pay the full premium cost of Company-sponsored death and/or disability insurance coverage for you in effect as of your Termination Date, if any, for a period of nine months following your Termination Date. Your rights and obligations under such insurance plans shall be governed by the specific terms of the plans. In the event you obtain comparable death and/or disability insurance coverage through other employment prior to the expiration of the nine month period of continuation coverage described herein, the Company's obligation to continue to provide such coverage shall cease as of the effective date of such comparable coverage. For purposes of this agreement, comparable coverage shall be deemed to include, at a minimum, coverage at the same benefit level at no cost to you. Should you obtain such comparable coverage, you agree to promptly notify the Company's Chief Executive Officer in writing at the Company's headquarters. (b) Health and Dental Insurance. Upon the termination of your employment, you and your dependents may be eligible to continue your health and/or dental insurance coverage under Company-sponsored plans, if any, pursuant to the federal law known as COBRA. In the event you elect COBRA continuation coverage, the Company will pay the full premium cost and any administrative fee for such continuation coverage for a period of nine months following your Termination Date. After that time, you will become responsible for the full premium cost and any administrative fee for such continuation coverage. You understand and acknowledge that it is solely your responsibility to elect COBRA continuation coverage if you desire such coverage. Your rights and obligations under such insurance plans shall be governed by the specific terms of the plans and COBRA. Information concerning COBRA rights, coverage and election will be sent to you under separate cover. In the event you and/or your dependent(s) become ineligible for COBRA continuation coverage during the nine month period of premium payments described herein, the Company shall reimburse you for the premium cost of health and/or dental insurance 1 coverage at the same monthly rate the Company would have paid for COBRA continuation coverage had you and/or your dependents remained eligible for such coverage. In the event you obtain comparable health and/or dental insurance coverage through other employment prior to the expiration of the nine month period of premium payments described herein, the Company's obligation to continue to provide such premium payments shall cease as of the effective date of such comparable coverage. For purposes of this agreement, comparable coverage shall be deemed to include, at a minimum, coverage at the same benefit level at no cost to you. Should you obtain such comparable coverage, you agree to promptly notify the Company's Chief Executive Officer in writing at the Company's headquarters. (c) Other Benefits. Except as specifically set forth in this Agreement, your right to, and participation in, all employee benefit plans of the Company shall terminate as of your Termination Date in accordance with the specific terms of each plan; provided however, and notwithstanding anything to the contrary herein, in no event shall you have any right to any benefits upon a change in control, except with respect to the specific benefits set forth in this Agreement. 4. STOCK OPTIONS. Except as provided in this paragraph 4, your interest in and rights in your Vested Stock Options (as defined and set forth in Exhibit A) shall be governed by and be subject to all conditions, terms and restrictions contained in the Company's 1993 Stock Option Plan, as amended from time to time ("the Plan"), and the option letter agreements dated April 25, 1997 (denoted as Exhibits A-1, A-2 and B to your Employment Agreement dated April 25, 1997, a copy of which is attached hereto as Exhibit B (the "Employment Agreement")), the option letter agreement dated August 28, 1998 (a copy of which is attached hereto as Exhibit C) and the option letter agreement dated March 1, 2000 (a copy of which is attached hereto as Exhibit D). Your rights with respect to your Stock Options shall be fixed as of your Termination Date and pursuant to this Agreement. With respect to the option letter agreements dated April 25, 1997 and denoted as Exhibits A-1 and A-2 to your Employment Agreement, all 250,000 options shall be deemed vested as of your Termination Date and you shall be entitled to exercise those options on or before February 15, 2003. With respect to the option letter agreement dated April 25, 1997 and denoted as Exhibit B to your Employment Agreement, 60,000 options shall be deemed vested as of your Termination Date and you shall be entitled to exercise those 60,000 options on or before February 15, 2003, and the 90,000 options that would have been unvested as of your Termination Date shall be accelerated and deemed to have become fully vested as of your Termination Date and you shall be entitled to exercise those 90,000 options on or before February 15, 2005. With respect to the option letter agreement dated August 28, 1998, you shall be entitled to exercise, at your election, some or all of the 105,000 options that are vested as of your Termination Date on a cashless basis (defined below) on the later of either: (a) your Termination Date; or (b) within five (5) business days following the expiration of the Revocation Period defined in paragraph 11. For purposes of this Agreement, the term "Cashless Basis" shall mean that in lieu of exercising some or all of your 105,000 vested stock options for cash, you shall be entitled to receive up to a total number of shares of common stock of the Company computed using the following formulas: X = 35,000 (A - $1.2375) ; and -------------------- A X = 35,000 (A - $2.125) ; and ------------------- A X = 35,000 (A - $3.125) ------------------- A where X equals the number of shares of common stock to be issued to you and A equals the fair market value of one share of common stock on the date of exercise. In addition, you may elect to have the Company withhold from the total number of shares due under the above formulas a number of shares having a fair market value equal to the minimum amount necessary to satisfy the Company's aggregate federal, state, local and foreign tax withholding and FICA and FUTA obligations due as a result of a Cashless Basis exercise. With respect to the option letter agreement dated March 1, 2000, you shall be entitled to exercise the 60,000 options that are vested as of your Termination Date on or before February 15, 2005. You acknowledge and agree that you shall forfeit any right to those 30,000 unvested stock options under the option letter agreement dated March 1, 2000, as shown in Exhibit A hereto. You acknowledge and agree that there has been no change of control at any time up to and including your Termination Date and that you shall have no rights to accelerated vesting or otherwise upon any change of control occurring after 2 your Termination Date. The Company agrees to take any action necessary to effectuate the terms of this paragraph 4. 5. STOCK PROXY. You agree that at the time you execute this Agreement, you will execute a proxy for all of your shares of Company common stock in favor of the President of the Company, Loren G. Peterson, or his designee, which proxy shall be in the form attached hereto as Exhibit E. The proxy shall be granted for a term of one year and shall not be limited in scope of authority. 6. RETURN OF COMPANY PROPERTY. You agree to return to the Company: (a) all originals and copies of all proprietary and/or confidential information and trade secrets of the Company; (b) all originals and copies of customer files; (c) all identification cards, keys, or other means of access to the Company; and (d) any other property of the Company in your possession, custody or control. All Company property must be returned no later than your Termination Date. 7. NONDISPARAGEMENT. You agree that you will not make disparaging or adverse remarks about, or refer negatively to your association with the Company, its parents, subsidiaries, affiliates, officers, directors, trustees, employees or any other Released Party defined in paragraph 10. The Company agrees that its Board of Directors and executive officers shall not make disparaging or adverse remarks about you, or refer negatively to your association with the Company. 8. NON-FILING OF COMPLAINT OR CHARGES. You represent that you have not filed or asserted any cause of action, claim, charge or other action or proceeding against the Company. 9. COOPERATION. You agree that you will cooperate and assist the Company in the future in the event that the Company is presented with legal issues as to which you have relevant information and knowledge. To the extent such cooperation is required, the Company agrees: (a) to reimburse you for reasonable out-of-pocket expenses actually incurred in connection with providing such cooperation so long as such expenses are approved in advance; and (b) to compensate you for your time at a reasonable rate. 10. GENERAL RELEASE. As a material inducement to the Company to enter into this Agreement, and in consideration of the good and valuable consideration contained herein, the receipt and sufficiency of which is hereby acknowledged, you, on behalf of yourself, your heirs, administrators, representatives, executors, successors, and assigns, hereby irrevocably and unconditionally release, acquit, and forever discharge Sheffield Pharmaceuticals, Inc. and its predecessors (including without limitation Sheffield Medical Technologies Inc.), parents, subsidiaries, affiliates, divisions, successors and assigns, and all of their current and former agents, officers, directors, employees, members, trustees, fiduciaries, representatives and attorneys (the "Released Parties") from any and all charges, complaints, claims, liabilities, obligations, promises, agreements, damages, causes of action, suits, demands, losses, debts, and expenses of any nature whatsoever, known or unknown ("Claims") which you have, had or claim to have against any Released Party up to and including the date you sign this Agreement. This General Release of Claims shall include, without limitation, Claims relating to your employment and separation from employment with the Company, Claims of discrimination under the common law or any federal or state statute (including, without limitation, the Civil Rights Act of 1964, the Americans with Disabilities Act and the Age Discrimination in Employment Act, all as amended), Claims for wrongful discharge, Claims for the payment of any salary, wages, vacation time, bonuses or commissions, Claims for severance or other benefits (other than as specifically set forth in paragraphs 2, 3 and 4 herein), Claims of detrimental reliance, and all other statutory, common law or other Claims of any nature whatsoever. This General Release of Claims does not apply to any Claims concerning a breach of this Agreement, including the option letter agreements referred to in Paragraph 4 as amended by this Agreement, or any claims arising after the date you sign this Agreement. With respect to the Claims you are waiving herein, you acknowledge that you are waiving your right to receive money or any other relief in any action instituted by you or on your behalf by any other person, entity or government agency. 11. NOTICE AND RIGHT TO CONSIDER. You are advised to consult with an attorney before executing this Agreement. You acknowledge that you have consulted with an attorney of your choosing, Charles Elbert, Esquire, in connection with your review of this Agreement. In any event, you should thoroughly review and understand the effect of this Agreement and its General Release before taking action upon them. You may have up to forty-five (45) days from January 14, 2002 (the date you first received the Company's written offer concerning the separation of your employment) to complete your review and sign the Agreement. You acknowledge that if you sign this 3 Agreement prior to the expiration of the forty-five (45) day period that you did so voluntarily. You will also have seven (7) days following your execution of this Agreement to revoke it (the "Revocation Period"). If you wish to revoke the Agreement, you must do so in writing, addressed to the Company's Chief Executive Officer at the Company's headquarters, and such revocation must be received by the Company prior to the expiration of the Revocation Period. If you sign this Agreement prior to your Termination Date, then you agree to execute the General Release attached hereto as Exhibit F on your Termination Date. Should you fail to do so, then this Agreement shall immediately become null and void. 12. AGE AND JOB TITLE INFORMATION. Attached to this letter as Exhibit G is a description of (i) any class, unit or group of individuals being offered the benefits that the Company has offered to you, and any applicable time limits regarding such offer; (ii) the job titles and ages of all individuals eligible or selected for such offer, and (iii) the ages of all individuals in the same job classification or organizational unit who are not eligible or selected for the offer. By signing this Agreement you acknowledge that you have received Exhibit G and understand its contents. 13. MISCELLANEOUS. This Agreement constitutes the full understanding and entire Agreement between you and the Company and supersedes and terminates any other agreements, communications and understandings of any kind, whether oral or written, formal or informal, including, without limitation, any agreement concerning benefits upon a change in control. Except for paragraphs 9, 10 and 11 (excluding any reference in paragraph 11 to paragraph 8) and the Exhibits to the Employment Agreement which have been referenced in this Agreement, the Employment Agreement by and between the parties is hereby superseded by this Agreement and shall be deemed null and void and of no further force or effect. You represent and acknowledge that in signing this Agreement, you have not relied upon any promise, inducement, representation or statement, whether oral or written, not set forth in this Agreement. This Agreement may be amended or modified only by a written instrument signed by the parties. The Company acknowledges that you are entitled to, and will continue to be entitled to, the same rights of indemnification as current officers and directors of the Company, to the fullest extent provided for under Delaware law and as more particularly set forth in the Company's By-Laws. The parties agree that the failure of a party at any time to require performance of any provision of this Agreement shall not affect, diminish, obviate or void in any way the Party's full right or ability to require performance of the same or any other provisions of this Agreement at any time thereafter. This Agreement shall inure to the benefit of and shall be binding upon you, your heirs, administrators, representatives, executors, successors and assigns and upon the successors and assigns of the Company. This Agreement shall be construed in accordance with and governed by the laws of the State of Missouri, without respect to its conflict of laws provisions. Should any portion, term or provision of this Agreement be declared or determined by any court to be illegal, invalid or unenforceable, the validity or the remaining portions, terms and provisions shall not be affected thereby, and the illegal, invalid or unenforceable portion, term or provision shall be deemed not to be part of this Agreement. The headings of the paragraphs of this Agreement are for convenience only and are not binding on any interpretation of this Agreement. In the event of any conflict between this Agreement and the stock option letter agreements referred to in paragraph 4, the provisions of this Agreement shall control. * * * If you wish to accept this Agreement, please sign and date the Agreement below and return it to me within the time period specified in paragraph 11. We wish you every success for the future. 4 Sincerely, /s/ Loren G. Peterson ------------------------------------- Loren G. Peterson President and Chief Executive Officer BY SIGNING THIS AGREEMENT, I STATE THAT I HAVE READ IT, I UNDERSTAND IT, I AGREE WITH EVERYTHING IN IT AND I HAVE SIGNED IT KNOWINGLY AND VOLUNTARILY. /s/ Carl F. Siekmann - -------------------- Carl F. Siekmann Date: 2/18/02 ------- 5 EXHIBIT A STOCK OPTIONS AS OF TERMINATION DATE
Exercise Period for Grant Date Total Shares Vested Stock Options Unvested Shares Exercise Price Vested Stock Options - ---------- ------------ -------------------- --------------- -------------- ------------------- 4/25/97 100,000 100,000 0 $2.75 To and including 2/15/03 (A-1 grant) 4/25/97 150,000 150,000 0 $2.75 To and including 2/15/03 (A-2 grant) 4/25/97 150,000 150,000 0 $2.75 60,000 to and including (B grant) 2/15/03 *** 90,000 to and including 2/15/05 8/28/98 105,000 35,000 at $1.2375 0 35,000 at $1.2375 see n. 1 35,000 at $2.125 35,000 at $2.125 35,000 at $3.125 35,000 at $3.125 3/01/00 90,000 30,000 at $4.75 30,000 at 30,000 at $4.75 To and including 2/15/05 30,000 at $5.3125 at $6.3125 30,000 at $5.3125 30,000 at $6.3125
n. 1: Either (at your election): (1) 35,000 at $1.2375; 35,000 at $2.125; 35,000 at $3.125; all within 90 days from your Termination Date; or (2) Some or all of the 105,000 options on a Cashless Basis, defined in paragraph 4 of the Agreement, on the later of either: (a) your Termination Date; or (b) within five (5) business days following the expiration of the Revocation Period, defined in paragraph 12 of the Agreement. 6 EXHIBIT B EMPLOYMENT AGREEMENT (INCLUDING EXHIBITS A-1, A-2 AND B) EMPLOYMENT AGREEMENT AGREEMENT made as of the 25th day of April, 1997, by and between Sheffield Medical Technologies Inc., a Delaware corporation with its principal offices at 30 Rockefeller Plaza, Suite 4515, New York, New York 10112 (the "Corporation"), and Carl F. Siekmann residing at 15915 Wetherburn Road, Chesterfield, Missouri 63017 ("Executive"). WITNESSETH WHEREAS, the Corporation desires to employ and retain Executive as its Executive Vice President - Corporate Development, upon the terms and subject to the conditions of this Agreement; and NOW, THEREFORE, in consideration of the premises and the mutual covenants hereinafter set forth, the parties hereto agree as follows: 1. Employment of Executive. The Corporation hereby employs Executive as its Executive Vice President - Corporate Development, to perform the duties and responsibilities traditionally incident to such office, subject at all times to the control and direction of the Board of Directors of the Corporation. 2. Acceptance of Employment; Offices; Time and Attention, Etc. (a) Executive hereby accepts such employment and agrees that throughout the period of his employment hereunder, except as hereinafter provided, he will devote his full business and professional time in utilizing his business and professional expertise, with proper attention, knowledge and skills faithfully, diligently and to the best of his ability in furtherance of the business of the Corporation and its subsidiaries and will perform the duties assigned to him pursuant to Paragraph 1 hereof. As Executive Vice President - Corporate Development, Executive shall also perform such specific duties and shall exercise such specific authority related to the management of the day-to-day operations of the Corporation and its subsidiaries as may be reasonably assigned to Executive from time to time by the Board of Directors of the Corporation. (b) Executive shall at all times be subject to, observe and carry out such rules, regulations, policies, directions and restrictions as the Board of Directors of the Corporation shall from time to time establish. During the period of his employment hereunder, Executive shall not, directly or indirectly, accept employment or compensation from, or perform services of any nature for, any business enterprise other than the Corporation and its subsidiaries. Notwithstanding the foregoing in this Paragraph 2, Executive shall not be precluded from engaging in recreational, eleemosynary, educational and other activities which do not materially interfere with his duties hereunder during vacations, holidays and other periods outside of business hours. (c) It is anticipated that the Corporation's principal executive office (now located in New York City) shall be relocated to St. Louis, Missouri but that Executive may be required to spend substantial amounts of time at locations in and outside of St. Louis, Missouri relating to the business of the Corporation and its subsidiaries. It is understood that Executive shall continue to reside in the vicinity of St. Louis, Missouri and that the Corporation shall maintain an office in St. Louis, Missouri, which is where Executive shall maintain his principal office until the Corporation relocates from New York City to St. Louis, Missouri. The Corporation agrees to reimburse Executive for his reasonable expenses, including hotel and travel costs, associated with the Corporation's business. In addition, until completion of such relocation, it is understood that Executive shall visit the Corporation's executive office in New York City on a regular basis for meetings and to conduct Corporation business that is more appropriately conducted from such executive office. 3. Term. Except as otherwise provided herein, the term of Executive's employment hereunder shall commence on the date of the consummation of the merger of Camelot Pharmacal, L.L.C., a Missouri limited liability company, with and into a subsidiary of the Company (the "Merger") and shall continue to and including April 25, 2002. Notwithstanding anything to the contrary contained in the Agreement, this Agreement shall terminate and have no force and effect in the event that the Merger is not consummated on or before June 6, 1997. Unless terminated earlier in accordance with the terms hereof, this Agreement shall automatically be extended for one or more additional consecutive one year terms unless either party notifies the other party in writing at least six months before the end of the then current term (including the initial term) of its or his desire to terminate this Agreement. The last day of the term of this Agreement pursuant to this Paragraph 3 (including any early termination pursuant to the terms hereof) is referred to herein as the "Termination Date". 4. Compensation. (a) As compensation for his services hereunder, the Corporation shall pay to Executive (i) a base annual salary at the rate of $160,000, payable in equal installments in accordance with the normal payroll practices of the Corporation but in no event less frequently than semi-monthly, and (ii) such incentive compensation and bonuses, if any, as the Board of Directors of the Corporation in its absolute discretion may determine to award Executive (it being understood that this Agreement shall in no event be construed to require the payment to Executive of any incentive compensation or bonuses), it being understood that Executive shall be entitled to receive such incentive compensation and bonuses determined on a basis comparable to the incentive compensation and/or bonuses awarded to other executive officers of the Corporation. All compensation paid to Executive shall be subject to withholding and other employment taxes imposed by applicable law. 7 (b) During the period of Executive's employment hereunder, Executive shall not be entitled to any additional compensation for rendering employment services to subsidiaries of the Corporation or for serving in any office of the Corporation or any of its subsidiaries to which he is elected or appointed. (c) In the event that Executive is elected to the Corporation's Board of Directors, Executive will receive compensation and benefits as a director of the Corporation consistent with the compensation and benefits received by the Corporation's other directors who are also employees of the Corporation. 5. Stock Options. (a) As additional compensation for his services hereunder, the Corporation shall grant to Executive an option under the Corporation's 1993 Stock Option Plan (the "Plan") to acquire a total of 400,000 shares of the Corporation's common stock at an exercise price per share equal to the closing sale price of the Corporation's common stock as reported by the American Stock Exchange on the date hereof, with the terms of such option to be evidenced by (i) one option letter agreement in the form annexed as Exhibit "A" hereto ("Option Letter A-1") being exercisable for 100,000 shares of Common Stock, (ii) one option letter agreement in the form annexed as Exhibit "A-2" hereto ("Option Letter A-2") being exercisable for 150,000 shares of Common Stock and (iii) one option letter agreement in the form annexed as Exhibit "B" hereto ("Option Letter B") being exercisable for 150,000 shares of Common Stock (such option letters being referred to collectively herein as the "Plan Option Letters"). (b) The Company represents and warrants that there are sufficient shares of Common Stock currently available under the Company's 1993 Stock Option Plan (the "1993 Plan") to cover the shares of Common Stock issuable to Executive upon exercise of Option Letter A-1. (c) In the event that the Company's stockholders fail at the next annual meeting of stockholders of the Corporation to approve both (i) an amendment increasing the number of shares available for the issuance of options under the Plan to an amount at least sufficient to cover all the shares of Common Stock issuable upon exercise of Option Letter A-2 and Option Letter B and (ii) appropriate amendments to the Plan specifically confirming the right of the Corporation's Board of Directors, in the issuance of stock options under the Plan, to determine provisions regarding terms of the exercise of such stock options (including without limitation, the period of exercisability of stock options under the Plan upon termination of employment for cause or without cause) and provisions regarding forfeiture of stock options under the Plan upon termination of employment, the Company agrees, upon receipt of a written demand from Executive, to promptly amend the Plan Option Letters to provide for three non-qualified options outside the Plan having substantially the same terms and provisions of the Plan Stock Options. (d) In the event that (i) the Corporation is required to amend the Plan Option Letters pursuant to Paragraph 5(c) or (ii) Executive's employment by the Corporation is terminated (x) by the Corporation for any reason other than for Cause, (y) by Executive as a result of an Employer Breach or (z) by the Corporation by reason of the Executive's disability or death prior to the expiration of the options evidenced by the Plan Option Letters and Executive is required after such event to pay any U.S. federal or state income and withholding tax (collectively, "Income Taxes") on any income recognized by Executive arising upon any exercise of options evidenced by the Plan Option Letters, the Corporation agrees to reimburse Executive the difference between (A) the amount of Income Taxes Executive would have been required to pay had the income recognized on such exercise been treated as a long term capital gain and (B) the amount of Income Taxes payable by Executive in respect of such exercise (the amount of such difference being referred to as the "Tax Difference" in respect of such exercise). In computing the Tax Difference, the amount of taxes payable by Executive shall be determined by assuming that the income recognized as a result of such exercise is taxed at the highest marginal federal and state income tax rates applicable to ordinary income. In addition, the Corporation shall pay Executive an amount equal to the Tax Difference arising in respect of such exercise multiplied by a fraction, the numerator of which is 1 and the denominator of which is equal to 1 minus (i) the highest marginal federal income tax rate (currently 39.6%) and (ii) the highest marginal state income tax rate applicable to Executive, in each case in respect of ordinary income, in effect at the time of such exercise. Such amount shall be paid by the Corporation within ninety (90) days after any such exercise. Notwithstanding anything to the contrary in this Agreement or the Plan Option Letters, the Corporation shall have no obligation to pay Executive any amount in excess of $250,000 in the aggregate in respect of its obligations under this subparagraph. 6. Additional Benefits; Vacation. (a) In addition to such base salary, Executive shall receive and be entitled to participate, to the extent he is eligible under the terms and conditions thereof, in any profit sharing, pension, retirement, hospitalization, disability, medical service, insurance or other employee benefit plan generally available to the executive officers of the Corporation that may be in effect from time to time during the period of Executive's employment hereunder. The Corporation agrees to cover Executive under any directors' and officers' liability policy maintained by the Corporation. (b) Executive shall be entitled to four (4) weeks' paid vacation in respect of each 12-month period during the term of his employment hereunder, such vacation to be taken at times mutually agreeable to Executive and the Board of Directors of the Corporation. (c) Executive shall be entitled to recognize as holidays all days recognized as such by the Corporation. 7. Reimbursement of Expenses. The Corporation shall reimburse Executive in accordance with applicable policies of the Corporation for all expenses reasonably incurred by him in connection with the performance of his duties hereunder and the business of the Corporation, upon the submission to the Corporation of appropriate receipts or vouchers. 8. Restrictive Covenant. (a) In consideration of the Corporation's entering into this Agreement, Executive agrees that during the period of his employment hereunder and, in the event of termination of this Agreement (i) by the Corporation upon Executive becoming Disabled (as that term is defined in Paragraph 13 hereof), (ii) by the Corporation for Cause (as that term, is defined in Paragraph 14 hereof) or (iii) by Executive otherwise than for 8 Employer Breach (as that term is defined in Paragraph 15 hereof), for a further period of six months thereafter, he will not (x) directly or indirectly own, manage, operate, join, control, participate in, invest in, whether as an officer, director, employee, partner, investor or otherwise, any business entity that is engaged in a directly competitive business (as hereinafter defined) to that of the Corporation or any of its subsidiaries within the United States of America, (y) for himself or on behalf of any other person, partnership, corporation or entity, call on any customer of the Corporation or any of its subsidiaries for the purpose of soliciting away, diverting or taking away any customer from the Corporation or its subsidiaries, or (z) solicit any person then engaged as an employee, representative, agent, independent contractor or otherwise by the Corporation or any of its subsidiaries, to terminate his or her relationship with the Corporation or any of its subsidiaries. For purposes of this Agreement, the term "directly competitive business" shall mean any business that is then involved in the research, development, manufacturing or commercialization in any way of any product, compound, device or method that acts or functions by, through or on the same active, binding or receptor site, mechanism of action, signaling pathway or channel as any product, compound, device or method that is or becomes a part of the Corporation's business or the business of any of its subsidiaries during Executive's employment by the Corporation or any of its subsidiaries. Nothing contained in this Agreement shall be deemed to prohibit Executive from investing his funds in securities of an issuer if the securities of such issuer are listed for trading on a national securities exchange or are traded in the over-the-counter market and Executive's holdings therein represent less than 10% of the total number of shares or principal amount of the securities of such issuer outstanding. (b) Executive acknowledges that the provisions of this Paragraph 8 are reasonable and necessary for the protection of the Corporation, and that each provision, and the period or periods of time, geographic areas and types and scope of restrictions on the activities specified herein are, and are intended to be, divisible. In the event that any provision of this Paragraph 8, including any sentence, clause or part hereof, shall be deemed contrary to law or invalid or unenforceable in any respect by a court of competent jurisdiction, the remaining provisions shall not be affected, but shall, subject to the discretion of such court, remain in full force and effect. 9. Confidential Information. (a) Executive shall hold in a fiduciary capacity for the benefit of the Corporation and its subsidiaries all confidential information, knowledge and data relating to or concerned with its operations, sales, business and affairs, and he shall not, at any time during his employment hereunder and for two years thereafter, use, disclose or divulge any such information, knowledge or data to any person, firm or corporation other than to the Corporation and its subsidiaries or their respective designees or except as may otherwise be reasonably required or desirable in connection with the business and affairs of the Corporation and its subsidiaries. (b) Notwithstanding anything to the contrary contained herein, Executive's obligations under Paragraph 9(a) hereof shall not apply to any information which: (i) becomes rightfully known to Executive subsequent or prior to his employment by the Corporation; (ii) is or becomes available to the public other than as a result of wrongful disclosure by Executive; (iii) becomes available to Executive subsequent to his employment by the Corporation on a nonconfidential basis from a source other than the Corporation or its agents which source has a right to disclose such information; or (iv) results from research and development and/or commercial operations at any time by or on behalf of any person, company or other entity with which or with whom Executive shall become associated (in a manner consistent with the terms of this Agreement) subsequent to his employment by the Corporation or its agents totally independent from any disclosure from the Corporation or its agents. (c) Notwithstanding anything to the contrary contained herein, in the event that Executive becomes legally compelled to disclose any confidential information, Executive will provide the Corporation with prompt notice so that the Corporation may seek a protective order or other appropriate remedy. In the event that such protective order or other remedy is not obtained, Executive shall furnish only such confidential information which is legally required to be disclosed. 10. Intellectual Property. Any idea, invention, design, written material, manual, system, procedure, improvement, development or discovery conceived, developed, created or made by Executive alone or with others, during the period of his employment hereunder and applicable to the business of the Corporation or any of its subsidiaries, whether or not patentable or registrable, shall become the sole and exclusive property of the Corporation or such subsidiary. Executive shall disclose the same promptly and completely to the Corporation and shall, during the period of his employment hereunder and at any time and from time to time hereafter at no cost to Executive (i) execute all documents reasonably requested by the Corporation for vesting in the Corporation or any of its subsidiaries the entire right, title and interest in and to the same, (ii) execute all documents reasonably requested by the Corporation for filing and prosecuting such applications for patents, trademarks, service marks and/or copyrights as the Corporation, in its sole discretion, may desire to prosecute, and (iii) give the Corporation all assistance it reasonably requires, including the giving of testimony in any suit, action or proceeding, in order to obtain, maintain and protect the Corporation's right therein and thereto. 11. Equitable Relief. The parties hereto acknowledge that Executive's services are unique and that, in the event of a breach or a threatened breach by Executive of any of his obligations under Paragraphs 8, 9 or 10 this Agreement, the Corporation shall not have an adequate remedy at law. Accordingly, in the event of any such breach or threatened breach by Executive, the Corporation shall be entitled to such equitable and injunctive relief as may be available to restrain Executive and any business, firm, partnership, individual, corporation or entity participating in 9 such breach or threatened breach from the violation of the provisions of Paragraph 8, 9 or 10 hereof. Nothing herein shall be construed as prohibiting the Corporation from pursuing any other remedies available at law or in equity for such breach or threatened breach, including the recovery of damages and the immediate termination of the employment of Executive hereunder, if and to the extent permitted hereunder. 12. Termination of Agreement; Termination of Employment; Severance; Survival. (a) This Agreement and Executive's employment hereunder shall terminate upon the first to occur of the following: (i) Executive becoming Disabled (as that term is defined in Paragraph 13 hereof); (ii) Executive's death; (iii) termination of Executive's employment by the Corporation for Cause or pursuant to subparagraph (b) of this Paragraph 12; (iv) termination of Executive's employment for Employer Breach and (v) the termination of this Agreement at the end of the term of this Agreement on the Termination Date pursuant to Paragraph 3. (b) Notwithstanding anything to the contrary contained in this Agreement, in the event of the termination of the Executive's employment by the Corporation for any reason (other than for Cause), Executive shall be paid a severance payment equal to 75% of Executive's then current annual base salary payable in nine equal monthly installments, with the first installment being payable on the date falling two weeks after the date of such termination and each additional installment being paid every month after such date until such severance is paid in full. In the event of such termination of the Executive's employment by the Corporation (other than for Cause), the Corporation shall have no further obligation to the Executive under this Agreement other than the Corporation's obligation (i) to make such severance payment to the Executive (ii) to pay Executive's COBRA premium payments for hospitalization and medical insurance coverage provided by the Corporation and to pay Executive's premiums on any death and/or disability insurance being maintained by the Corporation for Executive at the time of such termination, in each case until the payment in full of such severance payments (c) Paragraph 5(c) of this Agreement shall survive the termination of Executive's employment hereunder until the earlier to occur of Executive's exercise of all of the stock options granted pursuant to paragraph 5 and the expiration of all such stock options pursuant to the Stock Option Letters. Paragraphs 7, 8, 9, 10, 11 and 26 of this Agreement shall survive the termination of Executive's employment hereunder, except in the case of termination pursuant to Paragraph 15. 13. Disability. In the event that during the term of his employment by the Corporation Executive shall become Disabled (as that term is hereinafter defined) he shall continue to receive the full amount of the base salary to which he was theretofore entitled for a period of six months after he shall be deemed to have become Disabled (the "First Disability Payment Period"). If the First Disability Payment Period shall end prior to the Termination Date, Executive thereafter shall be entitled to receive salary at an annual rate equal to 80% of his then current base salary for a further period ending on the earlier of (i) six months thereafter or (ii) the Termination Date (the "Second Disability Payment Period"). Upon the expiration of the Second Disability Payment Period, Executive shall not be entitled to receive any further payments on account of his base salary until he shall cease to be Disabled and shall have resumed his duties hereunder and provided that the Corporation shall not have theretofore terminated this Agreement as hereinafter provided. The Corporation may terminate Executive's employment hereunder at any time after Executive is Disabled, upon at least 10 days' prior written notice; provided, however, that such termination shall not relieve the Corporation from its obligation to make the payments to Executive described above in this Paragraph 13. For the purposes of this Agreement, Executive shall be deemed to have become Disabled when (x) by reason of physical or mental incapacity, Executive is not able to perform his duties hereunder for a period of 90 consecutive days or for 120 days in any consecutive 180-day period or (y) when Executive's physician or a physician designated by the Corporation shall have determined that Executive shall not be able, by reason of physical or mental incapacity, to perform a substantial portion of his duties hereunder. In the event that Executive shall dispute any determination of his disability pursuant to clauses (x) or (y) above, the matter shall be resolved by the determination of three physicians qualified to practice medicine in the United States of America, one to be selected by each of the Corporation and Executive and the third to be selected by the designated physicians. If Executive shall receive benefits under any disability policy maintained by the Corporation, the Corporation shall be entitled to deduct the amount equal to the benefits so received from base salary that it otherwise would have been required to pay to Executive as provided above. 14. Termination for Cause. The Corporation may at any time upon written notice to Executive terminate Executive's employment for Cause. For purposes of this Agreement, the following shall constitute Cause: (i) the willful and repeated failure of Executive to perform any material duties hereunder or gross negligence of Executive in the performance of such duties, and if such failure or gross negligence is susceptible to cure by Executive, the failure to effect such cure within twenty (20) days after written notice of such failure or gross negligence is given to Executive; (ii) except as permitted hereunder, unexplained, willful and regular absences of Executive from the Corporation; (iii) excessive use of alcohol or illegal drugs, interfering with the performance of Executives duties hereunder; (iv) indictment for a crime of theft, embezzlement, fraud, misappropriation of funds, other acts of dishonesty or the violation of any law or ethical rule relating to Executive's employment; (v) indicted for any other felony or other crime involving moral turpitude by Executive; or (vi) the breach by Executive of any of the provisions of paragraphs 8, 9 or 10 and if such breach is susceptible of cure by Executive, the failure to effect such cure within twenty (20) days after written notice of such breach is given to Executive. For purposes of this Agreement, an action shall be considered "willful" if it is done intentionally, purposely or knowingly, distinguished from an act done carelessly, thoughtlessly or inadvertently. In any such event, Executive shall be entitled to receive his base salary to and including the date of termination. 15. Termination for Employer Breach. Executive may upon written notice to the Corporation terminate this Agreement (including paragraphs 8, 9, 10 and 11) in the event of the breach by the Corporation of any material provision of this Agreement, and if such breach is susceptible of cure, the failure to effect such cure within 20 days after written notice of such breach is given to the Corporation (an "Employer Breach"). Executive's right to terminate this Agreement under this Paragraph 15 shall be in addition to any other remedies Executive may have 10 under law or equity. Paragraphs 2(d), 7 and 12(b) of this Agreement shall survive the termination of this Agreement by Executive pursuant to this Paragraph 15. 16. Insurance Policies. The Corporation shall have the right from time to time to purchase, increase, modify or terminate insurance policies on the life of Executive for the benefit of the Corporation, in such amounts as the Corporation shall determine in its sole discretion. In connection therewith, Executive shall, at such time or times and at such place or places as the Corporation may reasonably direct, submit himself to such physical examinations and execute and deliver such documents as the Corporation may reasonably deem necessary or desirable. 17. Entire Agreement; Amendment. This Agreement constitutes the entire agreement of the parties hereto, and any prior agreement between the Corporation and Executive is hereby superseded and terminated effective immediately and shall be without further force or effect. No amendment or modification himself shall be valid or binding unless made in writing and signed by the party against whom enforcement thereof is sought. 18. Notices. Any notice required, permitted or desired to be given pursuant to any of the provisions of this Agreement shall be delivered in person or sent by responsible overnight delivery service or sent by certified mail, return receipt requested, postage and fees prepaid, if to the Corporation, at its address set forth above to the attention of the Corporation's Chief Financial Officer and, if to Executive, at his address set forth above. Either of the parties hereto may at any time and from time to time change the address to which notice shall be sent hereunder by notice to the other party given under this Paragraph 18. Notices shall be deemed effective upon receipt. 19. No Assignment; Binding Effect. Neither this Agreement, nor the right to receive any payments hereunder, may be assigned by either party without the other party's prior written consent. This Agreement shall be binding upon Executive, his heirs, executors and administrators and upon the Corporation, its successors and assigns. 20. Waivers. No course of dealing nor any delay on the part of either party in exercising any rights hereunder shall operate as a waiver of any such rights. No waiver of any default or breach of this Agreement shall be deemed a continuing waiver or a waiver of any other breach or default. 21. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, except that body of law relating to choice of laws. 22. Invalidity. If any clause, paragraph, section or part of this Agreement shall be held or declared to be void, invalid or illegal, for any reason, by any court of competent jurisdiction, such provision shall be ineffective but shall not in any way invalidate or affect any other clause, paragraph, section or part of this Agreement. 23. Further Assurances. Each of the parties shall execute such documents and take such other actions as may be reasonably requested by the other party to carry out the provisions and purposes of this Agreement in accordance with its terms. 24. Headings. The headings contained in this Agreement have been inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement. 25. Publicity. The Corporation and Executive agree that they will not make any press releases or other announcements prior to or at the time of execution of this Agreement with respect to the terms contemplated hereby, except as required by applicable law, without the prior approval of the other party, which approval will not be unreasonably withheld. 26. Arbitration. Any disputes arising under this Agreement shall be submitted to and determined by arbitration in New York City, New York; provided, however, that such arbitration shall be held in St. Louis, Missouri in the event that the Company's principal executive offices is located at the time of such dispute in St. Louis, Missouri. Such arbitration shall be conducted in accordance with the rules of the American Arbitration Association. Any award or decision of the arbitration shall be conclusive in the absence of fraud and judgment thereon may be entered in any court having jurisdiction thereof. The costs of such arbitration shall be paid by the non-prevailing party to the extent directed by the arbitrator(s). THIS AGREEMENT CONTAINS BINDING ARBITRATION PROVISIONS WHICH MAY BE ENFORCED BY THE PARTIES. 11 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the day and year first above written. SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi ------------------------------------ George Lombardi Vice President and Chief Financial Officer /s/ Carl F. Siekmann ------------------------------------ Carl F. Siekmann 12 EXHIBIT A-1 TO EMPLOYMENT AGREEMENT SHEFFIELD MEDICAL TECHNOLOGIES INC. 30 ROCKEFELLER PLAZA, SUITE 4515 NEW YORK, NEW YORK 10112 April 25, 1997 Carl F. Siekmann 15915 Wetherburn Road Chesterfield, Missouri 63017 At a meeting of the Board of Directors of Sheffield Medical Technologies Inc. (the "Company") held on April 22, 1997, the Board authorized the grant to you of an option (the "Option") to purchase one hundred thousand (100,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company. The Option is being granted in connection with the Employment Agreement dated as of April 25, 1997 between the Company and you (the "Employment Agreement"). The terms of the Option are set forth below. 1. No part of the Option is currently exercisable. Subject to any adjustment pursuant to paragraph 5 below, the Option is exercisable at an exercise price of $2.75 per Share. Subject to the paragraph 2 below, the Option may first be exercised on April 25, 1998 for 10,000 Shares and shall become exercisable for an additional 10,000 Shares on each April 25 thereafter to and including April 25, 2007. Subject to paragraph 2 below, the Option must be exercised as to any and all Shares on or prior to April 25, 2007 (on which date the Option will, to the extent not previously exercised, expire). 2. Notwithstanding anything to the contrary contained herein or in the Plan (as defined below): (a) In the event your employment by the Company is terminated for Cause (as such term is defined in the Employment Agreement) prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date. The Option shall then expire to the extent not exercised within such 90 day period. (b) In the event that your employment by the Company is terminated by the Company for any reason other than for Cause, by you as a result of an Employer Breach (as such term is defined in the Employment Agreement) or by the Company by reason of your disability or death prior to the expiration of the Option, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (c) In the event that your employment by the Company is terminated by you for any reason other than an Employer Breach prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the second anniversary of the date of this letter, the Option shall become immediately exercisable for such 90 day period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such 90 day period. (d) In the event that your employment by the Company is terminated by the Company by reason of your death or disability, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (e) In the event of a Change of Control, the Option shall, at your option exercised by written notice delivered to the Company, become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. As used in this paragraph, "Change of Control" shall mean (i) the merger, consolidation or other business combination of the Company with 13 or into another corporation with the effect that the shareholders of the Company immediately following the merger, consolidation or other business combination, hold 50% or less of the combined voting power of the then outstanding equity interests of the surviving corporation of such merger, consolidation or other business combination ordinarily (and apart from rights accruing under special circumstances) having the right to vote in the election of directors or (ii) the replacement of a majority of the Board of Directors of the Company in any given year as compared to the directors who constituted the Board at the beginning of such year, and such replacement shall not have been approved by the Board of Directors of the Company as constituted at the beginning of such year. If any of the options granted hereunder are treated as nonqualified stock options ("NQO") as the result of exceeding the $100,000 exercise limit contained in Section 422(d) of the Internal Revenue Code of 1986, as amended, the Company shall issue separate certificates representing those shares constituting incentive stock options ("ISO") and those shares constituting NQO's and shall identify the ISO shares as such on its stock transfer records. 3. Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. 4. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. 5. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the exercise price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. 6. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. 7. The Option does not confer upon you any right whatsoever as a stockholder of the Company. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, except as modified in accordance with the Plan by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding of the option, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi ---------------------------- George Lombardi Chief Financial Officer AGREED TO AND ACCEPTED: /s/ Carl F. Siekmann - -------------------- Carl F. Siekmann 14 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Medical Technologies Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Medical Technologies Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated as of April 25, 1997, ________ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- Carl F. Siekmann 15 EXHIBIT A-2 TO EMPLOYMENT AGREEMENT SHEFFIELD MEDICAL TECHNOLOGIES INC. 30 ROCKEFELLER PLAZA, SUITE 4515 NEW YORK, NEW YORK 10112 April 25, 1997 Carl F. Siekmann 15915 Wetherburn Road Chesterfield, Missouri 63017 At a meeting of the Board of Directors of Sheffield Medical Technologies Inc. (the "Company") held on April 22, 1997, the Board authorized the grant to you of an option (the "Option") to purchase one hundred thousand (150,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company. The Option is being granted in connection with the Employment Agreement dated as of April 25, 1997 between the Company and you (the "Employment Agreement"). The terms of the Option are set forth below. 1. No part of the Option is currently exercisable. Subject to any adjustment pursuant to paragraph 5 below, the Option is exercisable at an exercise price of $2.75 per Share. Subject to the paragraph 2 below, the Option may first be exercised on April 25, 1998 for 15,000 Shares and shall become exercisable for an additional 15,000 Shares on each April 25 thereafter to and including April 25, 2007. Subject to paragraph 2 below, the Option must be exercised as to any and all Shares on or prior to April 25, 2007 (on which date the Option will, to the extent not previously exercised, expire). 2. Notwithstanding anything to the contrary contained herein or in the Plan (as defined below): (a) In the event your employment by the Company is terminated for Cause (as such term is defined in the Employment Agreement) prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date. The Option shall then expire to the extent not exercised within such 90 day period. (b) In the event that your employment by the Company is terminated by the Company for any reason other than for Cause, by you as a result of an Employer Breach (as such term is defined in the Employment Agreement) or by the Company by reason of your disability or death prior to the expiration of the Option, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (c) In the event that your employment by the Company is terminated by you for any reason other than an Employer Breach prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the second anniversary of the date of this letter, the Option shall become immediately exercisable for such 90 day period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such 90 day period. (d) In the event that your employment by the Company is terminated by the Company by reason of your death or disability, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (e) In the event of a Change of Control, the Option shall, at your option exercised by written notice delivered to the Company, become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. As used in this paragraph, "Change of Control" shall mean (i) the merger, consolidation or other business combination of the Company with or into another corporation with the effect that the shareholders of the Company immediately following the merger, consolidation or other business combination, hold 50% or less of the combined voting power of the then outstanding equity interests of the surviving corporation of such merger, consolidation or other business combination ordinarily (and apart from rights accruing under special circumstances) having the right to vote in the election of directors or (ii) the replacement of a majority of the Board of Directors of the Company in any given year as compared to the directors who constituted the Board at the beginning of such year, and such replacement shall not have been approved by the Board of Directors of the Company as constituted at the beginning of such year. If any of the options granted hereunder are treated as nonqualified stock options ("NQO") as the result of exceeding the $100,000 exercise limit contained in Section 422(d) of the Internal Revenue Code of 1986, as amended, the Company shall issue separate certificates representing those shares constituting incentive stock options ("ISO") and those shares constituting NQO's and shall identify the ISO shares as such on its stock transfer records. 3. Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the 16 Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. 4. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. 5. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the exercise price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. 6. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. 7. The Option does not confer upon you any right whatsoever as a stockholder of the Company. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, except as modified in accordance with the Plan by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding of the option, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi ------------------- George Lombardi Chief Financial Officer AGREED TO AND ACCEPTED: /s/ Carl F. Siekmann - --------------------- Carl F. Siekmann 17 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Medical Technologies Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Medical Technologies Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated as of April 25, 1997, ________ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- Carl F. Siekmann 18 EXHIBIT B TO EMPLOYMENT AGREEMENT SHEFFIELD MEDICAL TECHNOLOGIES INC. 30 ROCKEFELLER PLAZA, SUITE 4515 NEW YORK, NEW YORK 10112 April 25, 1997 Carl F. Siekmann 15915 Wetherburn Road Chesterfield, Missouri 63017 At a meeting of the Board of Directors of Sheffield Medical Technologies Inc. (the "Company") held on April 22, 1997, the Board authorized the grant to you of an option (the "Option") to purchase one hundred and fifty (150,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company. The Option is being granted in connection with the Employment Agreement dated as of April 25, 1997 between the Company and you (the "Employment Agreement"). The terms of the Option are set forth below. 1. No part of the option is currently exercisable. Subject to any adjustment pursuant to paragraph 5 below, the Option is exercisable at an exercise price of $2.75 per Share. Subject to the paragraph 2 below, the Option may first be exercised on April 25, 1998 for 15,000 Shares and shall become exercisable for an additional 15,000 Shares on each April 25 thereafter to and including April 25, 2007. Subject to paragraph 2 below, the Option must be exercised as to any and all Shares on or prior to April 25, 2007 (on which date the Option will, to the extent not previously exercised, expire). 2. Notwithstanding anything to the contrary contained herein or in the Plan (as defined below): (a) In the event your employment by the Company is terminated for Cause (as such term is defined in the Employment Agreement) prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date. The Option shall then expire to the extent not exercised within such 90 day period. (b) In the event that your employment by the Company is terminated by the Company for any reason other than for Cause, by you as a result of an Employer Breach (as such term is defined in the Employment Agreement) or by the Company by reason of your disability or death prior to the expiration of the Option, the Option shall be exercisable for one year from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such one year period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (c) In the event that your employment by the Company is terminated by you for any reason other than an Employer Breach other than an Employer Breach prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such 90 day period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such 90 day period. (d) In the event that your employment by the Company is terminated by the Company by reason of your death or disability, the Option shall be exercisable for one year from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such one year period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (e) in the event of a Change of Control, the Option shall, at your option exercised by written notice delivered to the Company, be exercisable for one year from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such one year period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. As used in this paragraph, "Change of Control" shall mean (i) the merger, consolidation or other business combination of the Company with or into another corporation with the effect that the shareholders of the Company immediately following the merger, consolidation or other business combination, hold 50% or less of the combined voting power of the then outstanding equity interests of the surviving corporation of such merger, consolidation or other business combination ordinarily (and apart from rights accruing under special circumstances) having the right to vote in the election of directors or (ii) the replacement of a majority of the Board of Directors of the Company in any given year as compared to the directors who constituted the Board at the beginning of such year, and such replacement shall not have been approved by the Board of Directors of the Company as constituted at the beginning of such year. 19 If any of the options granted hereunder are treated as nonqualified stock options ("NQO") as the result of exceeding the $100,000 exercise limit contained in Section 422(d) of the Internal Revenue Code of 1986, as amended, the Company shall issue separate certificates representing those shares constituting incentive stock options ("ISO") and those shares constituting NQO's and shall identify the ISO shares as such on its stock transfer records. 3. Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. 4. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement Under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold) ; (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. 5. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the exercise price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the option prior to the happening of any of the foregoing events. 6. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. 7. The Option does not confer upon you any right whatsoever as a stockholder of the Company. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the option, except as modified in accordance with the Plan by the terms set forth herein. A copy of the Plan has -been delivered to you with this letter. The option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding of the Option, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi ------------------------ George Lombardi Chief Financial Officer AGREED TO AND ACCEPTED: /s/ Carl F. Siekmann - ----------------------- Carl F. Siekmann 20 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Medical Technologies Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Medical Technologies Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated as of April 25, 1997, _________ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $______ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- Carl F. Siekmann 21 EXHIBIT C OPTION LETTER AGREEMENT DATED AUGUST 28, 1998 SHEFFIELD PHARMACEUTICALS, INC. 425 SOUTH WOODSMILL ROAD ST. LOUIS, MISSOURI 63017 August 28, 1998 To: Carl F. Siekmann 15915 Wetherburn Road Chesterfield, Missouri 63017 At a meeting of the Stock Option Committee of the Board of Directors of Sheffield Pharmaceuticals, Inc. (the "Company") held on August 25, 1998, the Company authorized the grant to you as of the date hereof of an option (the "Option") to purchase one Hundred Fifty Five Thousand (105,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company (the "Common Stock"). No part of the option is currently exercisable. On or after August 28, 1999 and prior to August 28, 2008 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire), the Option may be exercised as follows: (i) as to 35,000 Shares, subsequent to the time that the Fair Market Value (as hereinafter defined) of the Common Stock equals or exceeds $1.2375 for 10 consecutive trading days (such Shares constituting the "First Tranche" of the Option); (ii) as to 35,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock equals or exceeds $2.125 for 10 consecutive trading days (such shares constituting the "Second Tranche" of the Option) and (iii) as to the remaining 35,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock exceeds $3.125 for 10 consecutive trading days (such Shares constituting the "Third Tranche" of the Option). As used herein, "Fair Market Value" means the closing price of the Common Stock on the principal U.S. national securities exchange on which the Common Stock is listed for trading (if the shares are so listed) or on the Nasdaq National Market or Small Cap Market (if the Common Shares are regularly quoted on the Nasdaq National Market or Small Cap Market), or, if not so listed or regularly quoted or if there is no such closing price, the mean between the closing bid and asked prices of the Common Stock on such exchange or on Nasdaq or in the over-the-counter market or, if such bid and asked prices shall not be available, as reported by any nationally recognized quotation service selected by the Company. Shares may be purchased by you upon exercise of the Option at the following respective purchase prices: (i) Shares constituting the First Tranche $1.2375 per Share; (ii) Shares constituting the Second Tranche $2.125 per Share; and (iii) Shares constituting the Third Tranche - $3.125 per Share. This Option must be exercised as to any and all Shares on or prior to August 28, 2008 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire). Notwithstanding anything to the contrary contained in this letter agreement, the following provisions shall apply: (a) In the event that Fair Market Value does not equal or exceed $1.2375 for 10 consecutive trading days prior to August 28, 2001 (the "Target Date"), the First Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the First Tranche will, to the extent not previously exercised, expire); (b) In the event that Fair Market Value does not equal or exceed $2.125 for 10 consecutive trading days prior to the Target Date, the Second Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the Second Tranche will, to the extent not previously exercised, expire); and 22 (c) In the event that Fair Market Value does not equal or exceed $3.125 for 10 consecutive trading days prior to the Target Date, the Third Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the Third Tranche will, to the extent not previously exercised, expire). Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this Option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the purchase price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. The Option does not confer upon you any right whatsoever as a stockholder of the Company. By accepting the Option, you acknowledge your agreement to advise the Company in writing at least five trading days prior to selling, assigning or otherwise transferring any of the Shares. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is not intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, 23 except as modified by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, Sheffield Pharmaceuticals, Inc. By: /s/ Loren G. Peterson -------------------------- Loren G. Peterson President and CEO AGREED TO AND ACCEPTED: /s/ Carl F. Siekmann -------------------- Carl F. Siekmann 24 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Pharmaceuticals, Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Pharmaceuticals, Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated August 28, 1998, ______ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefore at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan, as amended. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- Carl F. Siekmann 25 EXHIBIT D OPTION LETTER AGREEMENT DATED MARCH 1, 2000 SHEFFIELD PHARMACEUTICALS, INC. 425 SOUTH WOODSMILL ROAD ST. LOUIS, MISSOURI 63017 March 1, 2000 To: Carl F. Siekmann 15915 Wetherburn Chesterfield, MO 63017 At a meeting of the Stock Option Committee of the Board of Directors of Sheffield Pharmaceuticals, Inc. (the "Company") held on February 29, 2000, the Company authorized the grant to you as of the date hereof of an option (the "Option") to purchase Ninety Thousand (90,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company (the "Common Stock"). No part of the Option is currently exercisable. On or after March 1, 2001 and prior to March 1, 2010 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire), the Option may be exercised as follows: (i) as to 30,000 Shares, subsequent to the time that the Fair Market Value (as hereinafter defined) of the Common Stock equals or exceeds $4.75 for 10 consecutive trading days (such Shares constituting the "First Tranche" of the Option); (ii) as to 30,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock equals or exceeds $5.3125 for 10 consecutive trading days (such shares constituting the "Second Tranche" of the Option) and (iii) as to the remaining 30,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock exceeds $6.3125 for 10 consecutive trading days (such Shares constituting the "Third Tranche" of the Option). As used herein, "Fair Market Value" means the closing price of the Common Stock on the principal U.S. national securities exchange on which the Common Stock is listed for trading (if the shares are so listed) or on the Nasdaq National Market or Small Cap Market (if the Common Shares are regularly quoted on the Nasdaq National Market or Small Cap Market), or, if not so listed or regularly quoted or if there is no such closing price, the mean between the closing bid and asked prices of the Common Stock on such exchange or on Nasdaq or in the over-the-counter market or, if such bid and asked prices shall not be available, as reported by any nationally recognized quotation service selected by the Company. Shares may be purchased by you upon exercise of the Option at the following respective purchase prices: (i) Shares constituting the First Tranche - - $4.75 per Share; (ii) Shares constituting the Second Tranche - $5.3125 per Share; and (iii) Shares constituting the Third Tranche - $6.3125 per Share. This Option must be exercised as to any and all Shares on or prior to March 1, 2010 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire). Notwithstanding anything to the contrary contained in this letter agreement, the following provisions shall apply: (a) In the event that Fair Market Value does not equal or exceed $4.75 for 10 consecutive trading days prior to March 1, 2003 (the "Target Date"), the First Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the First Tranche will, to the extent not previously exercised, expire); (b) In the event that Fair Market Value does not equal or exceed $5.3125 for 10 consecutive trading days prior to the Target Date, the Second Tranche of the Option may be exercised on the Target 26 Date and for 60 days thereafter (after which 60th day the Option in respect of the Second Tranche will, to the extent not previously exercised, expire); and (c) In the event that Fair Market Value does not equal or exceed $6.3125 for 10 consecutive trading days prior to the Target Date, the Third Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the Third Tranche will, to the extent not previously exercised, expire). Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this Option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the purchase price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. The Option does not confer upon you any right whatsoever as a stockholder of the Company. By accepting the Option, you acknowledge your agreement to advise the Company in writing at least five trading days prior to selling, assigning or otherwise transferring any of the Shares. 27 The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is not intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, except as modified by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, Sheffield Pharmaceuticals, Inc. By: /s/ Loren G. Peterson ---------------------------------- Loren G. Peterson President AGREED TO AND ACCEPTED: /s/ Carl F. Siekmann ----------------------- Carl F. Siekmann 28 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Pharmaceuticals, Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Pharmaceuticals, Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated March 1, 2000, _______ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan, as amended. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- Carl F. Siekmann 29 EXHIBIT E IRREVOCABLE PROXY The undersigned, Carl F. Siekmann ("Holder"), an individual with a residential address of 15915 Wetherburn Road, Chesterfield, Missouri, 63017, hereby revokes any and all proxies heretofore granted with respect to any shares of common stock, $.01 par value (the "Stock"), of Sheffield Pharmaceuticals, Inc. ("Sheffield") held by Holder and, hereby irrevocably appoints the President of Sheffield, Loren G. Peterson, or his designee, and each of them, as attorney-in-fact and proxy of Holder to attend any and all meetings of the stockholders of Sheffield and to vote such Holder's Stock, to represent and otherwise to act for Holder in the same manner and with the same effect as if such Holder were personally present and to act by consent in the same manner and with the same effect as if Holder were executing such consent, with respect to any matter. Holder agrees that, so long as this Irrevocable Proxy remains in effect, Holder will not execute or deliver to any persons, any proxy forms relating to any meeting, or written consent in lieu of a meeting, of stockholders of Sheffield, will promptly provide Sheffield with copies of any communications related to Sheffield received by Holder and will not take any action inconsistent with this Irrevocable Proxy. The foregoing appointment shall be (a) absolute and irrevocable and (b) deemed coupled with an interest. This Irrevocable Proxy shall be effective for a period of one (1) year in accordance with Delaware law and may be relied upon by any third party. IN WITNESS WHEREOF, the undersigned Holder has executed this Irrevocable Proxy as of February 18, 2002. Witness: CARL F. SIEKMANN /s/ Sally Reiter /s/ Carl F. Siekmann - ---------------- -------------------- Witness print name: Sally Reiter ------------ 30 EXHIBIT F GENERAL RELEASE Carl F. Siekmann, in consideration of the good and valuable consideration contained in the attached Agreement ("the Agreement"), the receipt and sufficiency of which is hereby acknowledged, on behalf of himself, his heirs, administrators, representatives, executors, successors, and assigns, hereby irrevocably and unconditionally releases, acquits, and forever discharges Sheffield Pharmaceuticals, Inc. and its predecessors (including without limitation Sheffield Medical Technologies Inc.), parents, subsidiaries, affiliates, divisions, successors and assigns, and all of their current and former agents, officers, directors, employees, members, trustees, fiduciaries, representatives and attorneys (the "Released Parties") from any and all charges, complaints, claims, liabilities, obligations, promises, agreements, damages, causes of action, suits, demands, losses, debts, and expenses of any nature whatsoever, known or unknown ("Claims") which he has, had or claims to have against any Released Party up to and including the date he signs this General Release. This General Release of Claims shall include, without limitation, Claims relating to his employment and separation from employment with the Company, Claims of discrimination under the common law or any federal or state statute (including, without limitation, the Civil Rights Act of 1964, the Americans with Disabilities Act and the Age Discrimination in Employment Act, all as amended), Claims for wrongful discharge, Claims for the payment of any salary, wages, vacation time, bonuses or commissions, Claims for severance or other benefits (other than as specifically set forth in paragraphs 2, 3 and 4 of the Agreement), Claims of detrimental reliance, and all other statutory, common law or other Claims of any nature whatsoever. This General Release of Claims does not apply to any Claims concerning a breach of the Agreement, including the option letter agreements referred to in Paragraph 4 of the Agreement as amended by the Agreement, or any claims arising after the date you sign this General Release. With respect to the Claims being waived herein, Siekmann acknowledges that he is waiving his right to receive money or any other relief in any action instituted by him or on his behalf by any other person, entity or government agency. IN WITNESS WHEREOF, the undersigned Carl F. Siekmann has executed this General Release as of February 18, 2002. Witness: CARL F. SIEKMANN /s/ Sally Reiter /s/ Carl F. Siekmann - ---------------- -------------------- Witness print name: Sally Reiter ------------ 31 EXHIBIT G OLDER WORKERS BENEFIT PROTECTION ACT NOTICE TO EMPLOYEES AGE AND JOB TITLE INFORMATION In connection with the Agreement and the offer of benefits described therein, you are being provided with information as to (i) any class, unit or group of individuals covered by such offer; (ii) the job titles and ages of all individuals eligible or selected for the offer, and (iii) the ages of all individuals in the same job classification or organizational unit who are not eligible or selected for the offer. Eligible employees age forty (40) and over shall have forty-five (45) days to consider the Company's offer and may revoke their agreement to the offer within seven (7) days after their execution of the Agreement.
Departments or Ages of Employees Ages of Ineligible Units Affected Job Title Affected Employees - -------------- --------- ----------------- ------------------ Executive Officers Chairman 51 President and Chief Executive Officer 45 Executive Vice President, Corporate Development 58 Executive Vice President, Scientific Affairs 53 Vice President, Finance and Administration and 37 Chief Financial Officer Vice President, Pulmonary Delivery Systems 48
32
EX-10.38 9 c68433ex10-38.txt SEPARATION AGREEMENT EXHIBIT 10.38 February 18, 2002 Mr. David A. Byron 17674 Lasiandra Drive Chesterfield, Missouri 63017 Dear David: This letter follows up on the discussions we have had recently concerning the mutually agreeable separation of your employment for reasons other than cause with Sheffield Pharmaceuticals, Inc. (the "Company"). To assist you in your transition, the Company is offering to you certain severance and other benefits in exchange for the general release of claims and other terms set forth below. The specific terms of the Company's proposed agreement (the "Agreement") are as follows: 1. TERMINATION OF EMPLOYMENT. The effective date of your termination shall be January 11, 2002 (the "Termination Date"). The Company will pay you all wages earned and any accrued and unused vacation time in accordance with Company policy through your Termination Date. For the period from the date of this letter through your Termination Date, you will continue to perform your duties and responsibilities in your current position; provided however that the Company may at any time and in its sole discretion request that you vacate the Company's premises and cease performing any duties for the Company. In such event, the Company shall remain obligated to pay to you all wages due to you through your Termination Date. 2. SEVERANCE PAY. The Company will continue to pay your base salary, as in effect on your Termination Date, for a period of nine months following your Termination Date, subject to appropriate tax withholdings and authorized deductions, in accordance with the Company's regular payroll practices and regular pay schedule. 3. BENEFIT CONTINUATION. (a) Death and Disability Insurance. The Company will continue to pay the full premium cost of Company-sponsored death and/or disability insurance coverage for you in effect as of your Termination Date, if any, for a period of nine months following your Termination Date. Your rights and obligations under such insurance plans shall be governed by the specific terms of the plans. In the event you obtain comparable death and/or disability insurance coverage through other employment prior to the expiration of the nine month period of continuation coverage described herein, the Company's obligation to continue to provide such coverage shall cease as of the effective date of such comparable coverage. For purposes of this agreement, comparable coverage shall be deemed to include, at a minimum, coverage at the same benefit level at no cost to you. Should you obtain such comparable coverage, you agree to promptly notify the Company's Chief Executive Officer in writing at the Company's headquarters. (b) Health and Dental Insurance. Upon the termination of your employment, you and your dependents may be eligible to continue your health and/or dental insurance coverage under Company-sponsored plans, if any, pursuant to the federal law known as COBRA. In the event you elect COBRA continuation coverage, the Company will pay the full premium cost and any administrative fee for such continuation coverage for a period of nine months following your Termination Date. After that time, you will become responsible for the full premium cost and any administrative fee for such continuation coverage. You understand and acknowledge that it is solely your responsibility to elect COBRA continuation coverage if you desire such coverage. Your rights and obligations under such insurance plans shall be governed by the specific terms of the plans and COBRA. Information concerning COBRA rights, coverage and election will be sent to you under separate cover. In the event you and/or your dependent(s) become ineligible for COBRA continuation coverage during the nine month period of premium payments described herein, the Company shall reimburse you for the premium cost of health and/or dental insurance coverage at the same monthly rate the Company would have paid for COBRA continuation coverage had you and/or your dependents remained eligible for such coverage. In the event you obtain comparable health and/or dental insurance 1 coverage through other employment prior to the expiration of the nine month period of premium payments described herein, the Company's obligation to continue to provide such premium payments shall cease as of the effective date of such comparable coverage. For purposes of this agreement, comparable coverage shall be deemed to include, at a minimum, coverage at the same benefit level at no cost to you. Should you obtain such comparable coverage, you agree to promptly notify the Company's Chief Executive Officer in writing at the Company's headquarters. (c) Other Benefits. Except as specifically set forth in this Agreement, your right to, and participation in, all employee benefit plans of the Company shall terminate as of your Termination Date in accordance with the specific terms of each plan; provided however, and notwithstanding anything to the contrary herein, in no event shall you have any right to any benefits upon a change in control, except with respect to the specific benefits set forth in this Agreement. 4. STOCK OPTIONS. Except as provided in this paragraph 4, your interest in and rights in your Vested Stock Options (as defined and set forth in Exhibit A) shall be governed by and be subject to all conditions, terms and restrictions contained in the Company's 1993 Stock Option Plan, as amended from time to time ("the Plan"), and the option letter agreements dated April 25, 1997 (denoted as Exhibits A-1, A-2 and B to your Employment Agreement dated April 25, 1997, a copy of which is attached hereto as Exhibit B (the "Employment Agreement")), the option letter agreement dated August 28, 1998 (a copy of which is attached hereto as Exhibit C) and the option letter agreement dated March 1, 2000 (a copy of which is attached hereto as Exhibit D). Your rights with respect to your Stock Options shall be fixed as of your Termination Date and pursuant to this Agreement. With respect to the option letter agreements dated April 25, 1997 and denoted as Exhibit A-1 and A-2 to your Employment Agreement, all 250,000 options shall be deemed vested as of your Termination Date and you shall be entitled to exercise those options on or before January 11, 2003. With respect to the option letter agreement dated April 25, 1997 and denoted as Exhibit B to your Employment Agreement, 60,000 options shall be deemed vested as of your Termination Date and you shall be entitled to exercise those 60,000 options on or before January 11, 2003, and the 90,000 options that would have been unvested as of your Termination Date shall be accelerated and deemed to have become fully vested as of your Termination Date and you shall be entitled to exercise those 90,000 options on or before January 11, 2005. With respect to the option letter agreement dated August 28, 1998, you shall be entitled to exercise, at your election, some or all of the 105,000 options that are vested as of your Termination Date on a cashless basis (defined below) on the later of either: (a) your Termination Date; or (b) within five (5) business days following the expiration of the Revocation Period defined in paragraph 11. For purposes of this Agreement, the term "Cashless Basis" shall mean that in lieu of exercising some or all of your 105,000 vested stock options for cash, you shall be entitled to receive up to a total number of shares of common stock of the Company computed using the following formulas: X = 35,000 (A - $1.2375) ; and -------------------- A X = 35,000 (A - $2.125) ; and ------------------- A X = 35,000 (A - $3.125) ------------------- A where X equals the number of shares of common stock to be issued to you and A equals the fair market value of one share of common stock on the date of exercise. In addition, you may elect to have the Company withhold from the total number of shares due under the above formulas a number of shares having a fair market value equal to the minimum amount necessary to satisfy the Company's aggregate federal, state, local and foreign tax withholding and FICA and FUTA obligations due as a result of a Cashless Basis exercise. With respect to the option letter agreement dated March 1, 2000, you shall be entitled to exercise the 60,000 options that are vested as of your Termination Date on or before January 11, 2005. You acknowledge and agree that you shall forfeit any right to those 30,000 unvested stock options under the option letter agreement dated March 1, 2000, as shown in Exhibit A hereto. You acknowledge and agree that there has been no change of control at any time up to and including your Termination 2 Date and that you shall have no rights to accelerated vesting or otherwise upon any change of control occurring after your Termination Date. The Company agrees to take any action necessary to effectuate the terms of this paragraph 4. 5. STOCK PROXY. You agree that at the time you execute this Agreement, you will execute a proxy for all of your shares of Company common stock in favor of the President of the Company, Loren G. Peterson, or his designee, which proxy shall be in the form attached hereto as Exhibit E. The proxy shall be granted for a term of one year and shall not be limited in scope of authority. 6. RETURN OF COMPANY PROPERTY. You agree to return to the Company: (a) all originals and copies of all proprietary and/or confidential information and trade secrets of the Company; (b) all originals and copies of customer files; (c) all identification cards, keys, or other means of access to the Company; and (d) any other property of the Company in your possession, custody or control. All Company property must be returned no later than your Termination Date. The parties acknowledge and agree that Mr. Byron has returned his phone card and keys on his Termination Date and that Mr. Byron has represented that he has no other Company property in his possession, custody or control. 7. NONDISPARAGEMENT. You agree that you will not make disparaging or adverse remarks about, or refer negatively to your association with the Company, its parents, subsidiaries, affiliates, officers, directors, trustees, employees or any other Released Party defined in paragraph 10. The Company agrees that its Board of Directors and executive officers shall not make disparaging or adverse remarks about you, or refer negatively to your association with the Company. 8. NON-FILING OF COMPLAINT OR CHARGES. You represent that you have not filed or asserted any cause of action, claim, charge or other action or proceeding against the Company. 9. COOPERATION. You agree that you will cooperate and assist the Company in the future in the event that the Company is presented with legal issues as to which you have relevant information and knowledge. To the extent such cooperation is required, the Company agrees: (a) to reimburse you for reasonable out-of-pocket expenses actually incurred in connection with providing such cooperation so long as such expenses are approved in advance; and (b) to compensate you for your time at a reasonable rate. 10. GENERAL RELEASE. As a material inducement to the Company to enter into this Agreement, and in consideration of the good and valuable consideration contained herein, the receipt and sufficiency of which is hereby acknowledged, you, on behalf of yourself, your heirs, administrators, representatives, executors, successors, and assigns, hereby irrevocably and unconditionally release, acquit, and forever discharge Sheffield Pharmaceuticals, Inc. and its predecessors (including without limitation Sheffield Medical Technologies Inc.), parents, subsidiaries, affiliates, divisions, successors and assigns, and all of their current and former agents, officers, directors, employees, members, trustees, fiduciaries, representatives and attorneys (the "Released Parties") from any and all charges, complaints, claims, liabilities, obligations, promises, agreements, damages, causes of action, suits, demands, losses, debts, and expenses of any nature whatsoever, known or unknown ("Claims") which you have, had or claim to have against any Released Party up to and including the date you sign this Agreement. This General Release of Claims shall include, without limitation, Claims relating to your employment and separation from employment with the Company, Claims of discrimination under the common law or any federal or state statute (including, without limitation, the Civil Rights Act of 1964, the Americans with Disabilities Act and the Age Discrimination in Employment Act, all as amended), Claims for wrongful discharge, Claims for the payment of any salary, wages, vacation time, bonuses or commissions, Claims for severance or other benefits (other than as specifically set forth in paragraphs 2, 3 and 4 herein), Claims of detrimental reliance, and all other statutory, common law or other Claims of any nature whatsoever. This General Release of Claims does not apply to any Claims concerning a breach of this Agreement, including the option letter agreements referred to in Paragraph 4 as amended by this Agreement, or any claims arising after the date you sign this Agreement. With respect to the Claims you are waiving herein, you acknowledge that you are waiving your right to receive money or any other relief in any action instituted by you or on your behalf by any other person, entity or government agency. 3 11. NOTICE AND RIGHT TO CONSIDER. You are advised to consult with an attorney before executing this Agreement. You acknowledge that you have consulted with an attorney of your choosing, Mark S. Rubin, Esquire, in connection with your review of this Agreement. In any event, you should thoroughly review and understand the effect of this Agreement and its General Release before taking action upon them. You may have up to forty-five (45) days from January 7, 2002 (the date you first received the Company's written offer concerning the separation of your employment) to complete your review and sign this Agreement. You acknowledge that if you sign this Agreement prior to the expiration of the forty-five (45) day period that you did so voluntarily. You will also have seven (7) days following your execution of this Agreement to revoke it (the "Revocation Period"). If you wish to revoke the Agreement, you must do so in writing, addressed to the Company's Chief Executive Officer at the Company's headquarters, and such revocation must be received by the Company prior to the expiration of the Revocation Period. If you sign this Agreement prior to your Termination Date, then you agree to execute the General Release attached hereto as Exhibit F on your Termination Date. Should you fail to do so, then this Agreement shall immediately become null and void. 12. AGE AND JOB TITLE INFORMATION. Attached to this letter as Exhibit G is a description of (i) any class, unit or group of individuals being offered the benefits that the Company has offered to you, and any applicable time limits regarding such offer; (ii) the job titles and ages of all individuals eligible or selected for such offer, and (iii) the ages of all individuals in the same job classification or organizational unit who are not eligible or selected for the offer. By signing this Agreement you acknowledge that you have received Exhibit G and understand its contents. 13. MISCELLANEOUS. This Agreement constitutes the full understanding and entire Agreement between you and the Company and supersedes and terminates any other agreements, communications and understandings of any kind, whether oral or written, formal or informal, including, without limitation, any agreement concerning benefits upon a change in control. Except for paragraphs 9, 10 and 11 (excluding any reference in paragraph 11 to paragraph 8) and the Exhibits to the Employment Agreement which have been referenced in this Agreement, the Employment Agreement by and between the parties is hereby superseded by this Agreement and shall be deemed null and void and of no further force or effect. You represent and acknowledge that in signing this Agreement, you have not relied upon any promise, inducement, representation or statement, whether oral or written, not set forth in this Agreement. This Agreement may be amended or modified only by a written instrument signed by the parties. The Company acknowledges that you are entitled to, and will continue to be entitled to, the same rights of indemnification as current officers and directors of the Company, to the fullest extent provided for under Delaware law and as more particularly set forth in the Company's By-Laws. The parties agree that the failure of a party at any time to require performance of any provision of this Agreement shall not affect, diminish, obviate or void in any way the Party's full right or ability to require performance of the same or any other provisions of this Agreement at any time thereafter. This Agreement shall inure to the benefit of and shall be binding upon you, your heirs, administrators, representatives, executors, successors and assigns and upon the successors and assigns of the Company. This Agreement shall be construed in accordance with and governed by the laws of the State of Missouri, without respect to its conflict of laws provisions. Should any portion, term or provision of this Agreement be declared or determined by any court to be illegal, invalid or unenforceable, the validity or the remaining portions, terms and provisions shall not be affected thereby, and the illegal, invalid or unenforceable portion, term or provision shall be deemed not to be part of this Agreement. The headings of the paragraphs of this Agreement are for convenience only and are not binding on any interpretation of this Agreement. In the event of any conflict between this Agreement and the stock option letter agreements referred to in paragraph 4, the provisions of this Agreement shall control. 4 * * * If you wish to accept this Agreement, please sign and date the Agreement below and return it to me within the time period specified in paragraph 11. We wish you every success for the future. Sincerely, /s/ Loren G. Peterson -------------------------------------- Loren G. Peterson President and Chief Executive Officer BY SIGNING THIS AGREEMENT, I STATE THAT I HAVE READ IT, I UNDERSTAND IT, I AGREE WITH EVERYTHING IN IT AND I HAVE SIGNED IT KNOWINGLY AND VOLUNTARILY. /s/ David A. Byron ------------------ David A. Byron Date: 2/18/02 --------- 5 EXHIBIT A STOCK OPTIONS AS OF TERMINATION DATE
Exercise Period for Grant Date Total Shares Vested Stock Options Unvested Shares Exercise Price Vested Stock Options - ---------- ------------ -------------------- --------------- -------------- ------------------- 4/25/97 100,000 100,000 0 $2.75 To and including 1/11/03 (A-1 grant) 4/25/97 150,000 150,000 0 $2.75 To and including 1/11/03 (A-2 grant) 4/25/97 150,000 150,000 0 $2.75 60,000 to and including (B grant) 1/11/03 *** 90,000 to and including 1/11/05 8/28/98 105,000 35,000 at $1.2375 0 35,000 at $1.2375 see n. 1 35,000 at $2.125 35,000 at $2.125 35,000 at $3.125 35,000 at $3.125 3/01/00 90,000 30,000 at $4.75 30,000 at $6.3125 30,000 at $4.75 To and including 1/11/05 30,000 at $5.3125 30,000 at $5.3125 30,000 at $6.3125
n. 1: Either (at your election): (1) 35,000 at $1.2375; 35,000 at $2.125; 35,000 at $3.125; all within 90 days from your Termination Date; or (2) Some or all of the 105,000 options on a Cashless Basis, defined in paragraph 4 of the Agreement, on the later of either: (a) your Termination Date; or (b) within five (5) business days following the expiration of the Revocation Period, defined in paragraph 12 of the Agreement. 6 EXHIBIT B EMPLOYMENT AGREEMENT (INCLUDING EXHIBITS A-1, A-2 AND B) EMPLOYMENT AGREEMENT AGREEMENT made as of the 25th day of April, 1997, by and between Sheffield Medical Technologies Inc., a Delaware corporation with its principal offices at 30 Rockefeller Plaza, Suite 4515, New York, New York 10112 (the "Corporation"), and David A. Byron residing at 17674 Lasiandra Drive, Chesterfield, Missouri 63017 ("Executive"). WITNESSETH WHEREAS, the Corporation desires to employ and retain Executive as its Executive Vice President - Scientific Affairs, upon the terms and subject to the conditions of this Agreement; and NOW, THEREFORE, in consideration of the premises and the mutual covenants hereinafter set forth, the parties hereto agree as follows: 1. Employment of Executive. The Corporation hereby employs Executive as its Executive Vice President - Scientific Affairs, to perform the duties and responsibilities traditionally incident to such office, subject at all times to the control and direction of the Board of Directors of the Corporation. 2. Acceptance of Employment; Offices; Time and Attention, Etc. (a) Executive hereby accepts such employment and agrees that throughout the period of his employment hereunder, except as hereinafter provided, he will devote his full business and professional time in utilizing his business and professional expertise, with proper attention, knowledge and skills faithfully, diligently and to the best of his ability in furtherance of the business of the Corporation and its subsidiaries and will perform the duties assigned to him pursuant to Paragraph 1 hereof. As Executive Vice President - Scientific Affairs, Executive shall also perform such specific duties and shall exercise such specific authority related to the management of the day-to-day operations of the Corporation and its subsidiaries as may be reasonably assigned to Executive from time to time by the Board of Directors of the Corporation. (b) Executive shall at all times be subject to, observe and carry out such rules, regulations, policies, directions and restrictions as the Board of Directors of the Corporation shall from time to time establish. During the period of his employment hereunder, Executive shall not, directly or indirectly, accept employment or compensation from, or perform services of any nature for, any business enterprise other than the Corporation and its subsidiaries. Notwithstanding the foregoing in this Paragraph 2, Executive shall not be precluded from engaging in recreational, eleemosynary, educational and other activities which do not materially interfere with his duties hereunder during vacations, holidays and other periods outside of business hours. (c) It is anticipated that the Corporation's principal executive office (now located in New York City) shall be relocated to St. Louis, Missouri but that Executive may be required to spend substantial amounts of time at locations in and outside of St. Louis, Missouri relating to the business of the Corporation and its subsidiaries. It is understood that Executive shall continue to reside in the vicinity of St. Louis, Missouri and that the Corporation shall maintain an office in St. Louis, Missouri, which is where Executive shall maintain his principal office until the Corporation relocates from New York City to St. Louis, Missouri. The Corporation agrees to reimburse Executive for his reasonable expenses, including hotel and travel costs, associated with the Corporation's business. In addition, until completion of such relocation, it is understood that Executive shall visit the Corporation's executive office in New York City on a regular basis for meetings and to conduct Corporation business that is more appropriately conducted from such executive office. 3. Term. Except as otherwise provided herein, the term of Executive's employment hereunder shall commence on the date of the consummation of the merger of Camelot Pharmacal, L.L.C., a Missouri limited liability company, with and into a subsidiary of the Company (the "Merger") and shall continue to and including April 25, 2002. Notwithstanding anything to the contrary contained in the Agreement, this Agreement shall terminate and have no force and effect in the event that the Merger is not consummated on or before June 6, 1997. Unless terminated earlier in accordance with the terms hereof, this Agreement shall automatically be extended for one or more additional consecutive one year terms unless either party notifies the other party in writing at least six months before the end of the then current term (including the initial term) of its or his desire to terminate this Agreement. The last day of the term of this Agreement pursuant to this Paragraph 3 (including any early termination pursuant to the terms hereof) is referred to herein as the "Termination Date". 4. Compensation. (a) As compensation for his services hereunder, the Corporation shall pay to Executive (i) a base annual salary at the rate of $160,000, payable in equal installments in accordance with the normal payroll practices of the Corporation but in no event less frequently than semi-monthly, and (ii) such incentive compensation and bonuses, if any, as the Board of Directors of the Corporation in its absolute discretion may determine to award Executive (it being understood that this Agreement shall in no event be construed to require the payment to Executive of any incentive compensation or bonuses), it being understood that Executive shall be entitled to receive such incentive compensation and bonuses determined on a basis comparable to the incentive compensation and/or bonuses awarded to other executive officers of the Corporation. All compensation paid to Executive shall be subject to withholding and other employment taxes imposed by applicable law. 7 (b) During the period of Executive's employment hereunder, Executive shall not be entitled to any additional compensation for rendering employment services to subsidiaries of the Corporation or for serving in any office of the Corporation or any of its subsidiaries to which he is elected or appointed. (c) In the event that Executive is elected to the Corporation's Board of Directors, Executive will receive compensation and benefits as a director of the Corporation consistent with the compensation and benefits received by the Corporation's other directors who are also employees of the Corporation. 5. Stock Options. (a) As additional compensation for his services hereunder, the Corporation shall grant to Executive an option under the Corporation's 1993 Stock Option Plan (the "Plan") to acquire a total of 400,000 shares of the Corporation's common stock at an exercise price per share equal to the closing sale price of the Corporation's common stock as reported by the American Stock Exchange on the date hereof, with the terms of such option to be evidenced by (i) one option letter agreement in the form annexed as Exhibit "A" hereto ("Option Letter A-1") being exercisable for 100,000 shares of Common Stock, (ii) one option letter agreement in the form annexed as Exhibit "A-2" hereto ("Option Letter A-2") being exercisable for 150,000 shares of Common Stock and (iii) one option letter agreement in the form annexed as Exhibit "B" hereto ("Option Letter B") being exercisable for 150,000 shares of Common Stock (such option letters being referred to collectively herein as the "Plan Option Letters"). (b) The Company represents and warrants that there are sufficient shares of Common Stock currently available under the Company's 1993 Stock Option Plan (the "1993 Plan") to cover the shares of Common Stock issuable to Executive upon exercise of Option Letter A-1. (c) In the event that the Company's stockholders fail at the next annual meeting of stockholders of the Corporation to approve both (i) an amendment increasing the number of shares available for the issuance of options under the Plan to an amount at least sufficient to cover all the shares of Common Stock issuable upon exercise of Option Letter A-2 and Option Letter B and (ii) appropriate amendments to the Plan specifically confirming the right of the Corporation's Board of Directors, in the issuance of stock options under the Plan, to determine provisions regarding terms of the exercise of such stock options (including without limitation, the period of exercisability of stock options under the Plan upon termination of employment for cause or without cause) and provisions regarding forfeiture of stock options under the Plan upon termination of employment, the Company agrees, upon receipt of a written demand from Executive, to promptly amend the Plan Option Letters to provide for three non-qualified options outside the Plan having substantially the same terms and provisions of the Plan Stock Options. (d) In the event that (i) the Corporation is required to amend the Plan Option Letters pursuant to Paragraph 5(c) or (ii) Executive's employment by the Corporation is terminated (x) by the Corporation for any reason other than for Cause, (y) by Executive as a result of an Employer Breach or (z) by the Corporation by reason of the Executive's disability or death prior to the expiration of the options evidenced by the Plan Option Letters and Executive is required after such event to pay any U.S. federal or state income and withholding tax (collectively, "Income Taxes") on any income recognized by Executive arising upon any exercise of options evidenced by the Plan Option Letters, the Corporation agrees to reimburse Executive the difference between (A) the amount of Income Taxes Executive would have been required to pay had the income recognized on such exercise been treated as a long term capital gain and (B) the amount of Income Taxes payable by Executive in respect of such exercise (the amount of such difference being referred to as the "Tax Difference" in respect of such exercise). In computing the Tax Difference, the amount of taxes payable by Executive shall be determined by assuming that the income recognized as a result of such exercise is taxed at the highest marginal federal and state income tax rates applicable to ordinary income. In addition, the Corporation shall pay Executive an amount equal to the Tax Difference arising in respect of such exercise multiplied by a fraction, the numerator of which is 1 and the denominator of which is equal to 1 minus (i) the highest marginal federal income tax rate (currently 39.6%) and (ii) the highest marginal state income tax rate applicable to Executive, in each case in respect of ordinary income, in effect at the time of such exercise. Such amount shall be paid by the Corporation within ninety (90) days after any such exercise. Notwithstanding anything to the contrary in this Agreement or the Plan Option Letters, the Corporation shall have no obligation to pay Executive any amount in excess of $250,000 in the aggregate in respect of its obligations under this subparagraph. 6. Additional Benefits; Vacation. (a) In addition to such base salary, Executive shall receive and be entitled to participate, to the extent he is eligible under the terms and conditions thereof, in any profit sharing, pension, retirement, hospitalization, disability, medical service, insurance or other employee benefit plan generally available to the executive officers of the Corporation that may be in effect from time to time during the period of Executive's employment hereunder. The Corporation agrees to cover Executive under any directors' and officers' liability policy maintained by the Corporation. (b) Executive shall be entitled to four (4) weeks' paid vacation in respect of each 12-month period during the term of his employment hereunder, such vacation to be taken at times mutually agreeable to Executive and the Board of Directors of the Corporation. (c) Executive shall be entitled to recognize as holidays all days recognized as such by the Corporation. 7. Reimbursement of Expenses. The Corporation shall reimburse Executive in accordance with applicable policies of the Corporation for all expenses reasonably incurred by him in connection with the performance of his duties hereunder and the business of the Corporation, upon the submission to the Corporation of appropriate receipts or vouchers. 8. Restrictive Covenant. (a) In consideration of the Corporation's entering into this Agreement, Executive agrees that during the period of his employment hereunder and, in the event of termination of this Agreement (i) by the Corporation upon Executive becoming Disabled (as that term is defined in Paragraph 13 hereof), (ii) by the Corporation for Cause (as that term, is defined in Paragraph 14 hereof) or (iii) by Executive otherwise than for Employer Breach (as that term is defined in Paragraph 15 hereof), for a further period of six months thereafter, he 8 will not (x) directly or indirectly own, manage, operate, join, control, participate in, invest in, whether as an officer, director, employee, partner, investor or otherwise, any business entity that is engaged in a directly competitive business (as hereinafter defined) to that of the Corporation or any of its subsidiaries within the United States of America, (y) for himself or on behalf of any other person, partnership, corporation or entity, call on any customer of the Corporation or any of its subsidiaries for the purpose of soliciting away, diverting or taking away any customer from the Corporation or its subsidiaries, or (z) solicit any person then engaged as an employee, representative, agent, independent contractor or otherwise by the Corporation or any of its subsidiaries, to terminate his or her relationship with the Corporation or any of its subsidiaries. For purposes of this Agreement, the term "directly competitive business" shall mean any business that is then involved in the research, development, manufacturing or commercialization in any way of any product, compound, device or method that acts or functions by, through or on the same active, binding or receptor site, mechanism of action, signaling pathway or channel as any product, compound, device or method that is or becomes a part of the Corporation's business or the business of any of its subsidiaries during Executive's employment by the Corporation or any of its subsidiaries. Nothing contained in this Agreement shall be deemed to prohibit Executive from investing his funds in securities of an issuer if the securities of such issuer are listed for trading on a national securities exchange or are traded in the over-the-counter market and Executive's holdings therein represent less than 10% of the total number of shares or principal amount of the securities of such issuer outstanding. (b) Executive acknowledges that the provisions of this Paragraph 8 are reasonable and necessary for the protection of the Corporation, and that each provision, and the period or periods of time, geographic areas and types and scope of restrictions on the activities specified herein are, and are intended to be, divisible. In the event that any provision of this Paragraph 8, including any sentence, clause or part hereof, shall be deemed contrary to law or invalid or unenforceable in any respect by a court of competent jurisdiction, the remaining provisions shall not be affected, but shall, subject to the discretion of such court, remain in full force and effect. 9. Confidential Information. (a) Executive shall hold in a fiduciary capacity for the benefit of the Corporation and its subsidiaries all confidential information, knowledge and data relating to or concerned with its operations, sales, business and affairs, and he shall not, at any time during his employment hereunder and for two years thereafter, use, disclose or divulge any such information, knowledge or data to any person, firm or corporation other than to the Corporation and its subsidiaries or their respective designees or except as may otherwise be reasonably required or desirable in connection with the business and affairs of the Corporation and its subsidiaries. (b) Notwithstanding anything to the contrary contained herein, Executive's obligations under Paragraph 9(a) hereof shall not apply to any information which: (i) becomes rightfully known to Executive subsequent or prior to his employment by the Corporation; (ii) is or becomes available to the public other than as a result of wrongful disclosure by Executive; (iii) becomes available to Executive subsequent to his employment by the Corporation on a nonconfidential basis from a source other than the Corporation or its agents which source has a right to disclose such information; or (iv) results from research and development and/or commercial operations at any time by or on behalf of any person, company or other entity with which or with whom Executive shall become associated (in a manner consistent with the terms of this Agreement) subsequent to his employment by the Corporation or its agents totally independent from any disclosure from the Corporation or its agents. (c) Notwithstanding anything to the contrary contained herein, in the event that Executive becomes legally compelled to disclose any confidential information, Executive will provide the Corporation with prompt notice so that the Corporation may seek a protective order or other appropriate remedy. In the event that such protective order or other remedy is not obtained, Executive shall furnish only such confidential information which is legally required to be disclosed. 10. Intellectual Property. Any idea, invention, design, written material, manual, system, procedure, improvement, development or discovery conceived, developed, created or made by Executive alone or with others, during the period of his employment hereunder and applicable to the business of the Corporation or any of its subsidiaries, whether or not patentable or registrable, shall become the sole and exclusive property of the Corporation or such subsidiary. Executive shall disclose the same promptly and completely to the Corporation and shall, during the period of his employment hereunder and at any time and from time to time hereafter at no cost to Executive (i) execute all documents reasonably requested by the Corporation for vesting in the Corporation or any of its subsidiaries the entire right, title and interest in and to the same, (ii) execute all documents reasonably requested by the Corporation for filing and prosecuting such applications for patents, trademarks, service marks and/or copyrights as the Corporation, in its sole discretion, may desire to prosecute, and (iii) give the Corporation all assistance it reasonably requires, including the giving of testimony in any suit, action or proceeding, in order to obtain, maintain and protect the Corporation's right therein and thereto. 11. Equitable Relief. The parties hereto acknowledge that Executive's services are unique and that, in the event of a breach or a threatened breach by Executive of any of his obligations under Paragraphs 8, 9 or 10 this Agreement, the Corporation shall not have an adequate remedy at law. Accordingly, in the event of any such breach or threatened breach by Executive, the Corporation shall be entitled to such equitable and injunctive relief as may be available to restrain Executive and any business, firm, partnership, individual, corporation or entity participating in such breach or threatened breach from the violation of the provisions of Paragraph 8, 9 or 10 hereof. Nothing herein 9 shall be construed as prohibiting the Corporation from pursuing any other remedies available at law or in equity for such breach or threatened breach, including the recovery of damages and the immediate termination of the employment of Executive hereunder, if and to the extent permitted hereunder. 12. Termination of Agreement; Termination of Employment; Severance; Survival. (a) This Agreement and Executive's employment hereunder shall terminate upon the first to occur of the following: (i) Executive becoming Disabled (as that term is defined in Paragraph 13 hereof); (ii) Executive's death; (iii) termination of Executive's employment by the Corporation for Cause or pursuant to subparagraph (b) of this Paragraph 12; (iv) termination of Executive's employment for Employer Breach and (v) the termination of this Agreement at the end of the term of this Agreement on the Termination Date pursuant to Paragraph 3. (b) Notwithstanding anything to the contrary contained in this Agreement, in the event of the termination of the Executive's employment by the Corporation for any reason (other than for Cause), Executive shall be paid a severance payment equal to 75% of Executive's then current annual base salary payable in nine equal monthly installments, with the first installment being payable on the date falling two weeks after the date of such termination and each additional installment being paid every month after such date until such severance is paid in full. In the event of such termination of the Executive's employment by the Corporation (other than for Cause), the Corporation shall have no further obligation to the Executive under this Agreement other than the Corporation's obligation (i) to make such severance payment to the Executive (ii) to pay Executive's COBRA premium payments for hospitalization and medical insurance coverage provided by the Corporation and to pay Executive's premiums on any death and/or disability insurance being maintained by the Corporation for Executive at the time of such termination, in each case until the payment in full of such severance payments (c) Paragraph 5(c) of this Agreement shall survive the termination of Executive's employment hereunder until the earlier to occur of Executive's exercise of all of the stock options granted pursuant to paragraph 5 and the expiration of all such stock options pursuant to the Stock Option Letters. Paragraphs 7, 8, 9, 10, 11 and 26 of this Agreement shall survive the termination of Executive's employment hereunder, except in the case of termination pursuant to Paragraph 15. 13. Disability. In the event that during the term of his employment by the Corporation Executive shall become Disabled (as that term is hereinafter defined) he shall continue to receive the full amount of the base salary to which he was theretofore entitled for a period of six months after he shall be deemed to have become Disabled (the "First Disability Payment Period"). If the First Disability Payment Period shall end prior to the Termination Date, Executive thereafter shall be entitled to receive salary at an annual rate equal to 80% of his then current base salary for a further period ending on the earlier of (i) six months thereafter or (ii) the Termination Date (the "Second Disability Payment Period"). Upon the expiration of the Second Disability Payment Period, Executive shall not be entitled to receive any further payments on account of his base salary until he shall cease to be Disabled and shall have resumed his duties hereunder and provided that the Corporation shall not have theretofore terminated this Agreement as hereinafter provided. The Corporation may terminate Executive's employment hereunder at any time after Executive is Disabled, upon at least 10 days' prior written notice; provided, however, that such termination shall not relieve the Corporation from its obligation to make the payments to Executive described above in this Paragraph 13. For the purposes of this Agreement, Executive shall be deemed to have become Disabled when (x) by reason of physical or mental incapacity, Executive is not able to perform his duties hereunder for a period of 90 consecutive days or for 120 days in any consecutive 180-day period or (y) when Executive's physician or a physician designated by the Corporation shall have determined that Executive shall not be able, by reason of physical or mental incapacity, to perform a substantial portion of his duties hereunder. In the event that Executive shall dispute any determination of his disability pursuant to clauses (x) or (y) above, the matter shall be resolved by the determination of three physicians qualified to practice medicine in the United States of America, one to be selected by each of the Corporation and Executive and the third to be selected by the designated physicians. If Executive shall receive benefits under any disability policy maintained by the Corporation, the Corporation shall be entitled to deduct the amount equal to the benefits so received from base salary that it otherwise would have been required to pay to Executive as provided above. 14. Termination for Cause. The Corporation may at any time upon written notice to Executive terminate Executive's employment for Cause. For purposes of this Agreement, the following shall constitute Cause: (i) the willful and repeated failure of Executive to perform any material duties hereunder or gross negligence of Executive in the performance of such duties, and if such failure or gross negligence is susceptible to cure by Executive, the failure to effect such cure within twenty (20) days after written notice of such failure or gross negligence is given to Executive; (ii) except as permitted hereunder, unexplained, willful and regular absences of Executive from the Corporation; (iii) excessive use of alcohol or illegal drugs, interfering with the performance of Executives duties hereunder; (iv) indictment for a crime of theft, embezzlement, fraud, misappropriation of funds, other acts of dishonesty or the violation of any law or ethical rule relating to Executive's employment; (v) indicted for any other felony or other crime involving moral turpitude by Executive; or (vi) the breach by Executive of any of the provisions of paragraphs 8, 9 or 10 and if such breach is susceptible of cure by Executive, the failure to effect such cure within twenty (20) days after written notice of such breach is given to Executive. For purposes of this Agreement, an action shall be considered "willful" if it is done intentionally, purposely or knowingly, distinguished from an act done carelessly, thoughtlessly or inadvertently. In any such event, Executive shall be entitled to receive his base salary to and including the date of termination. 15. Termination for Employer Breach. Executive may upon written notice to the Corporation terminate this Agreement (including paragraphs 8, 9, 10 and 11) in the event of the breach by the Corporation of any material provision of this Agreement, and if such breach is susceptible of cure, the failure to effect such cure within 20 days after written notice of such breach is given to the Corporation (an "Employer Breach"). Executive's right to terminate this Agreement under this Paragraph 15 shall be in addition to any other remedies Executive may have under law or equity. Paragraphs 2(d), 7 and 12(b) of this Agreement shall survive the termination of this Agreement by Executive pursuant to this Paragraph 15. 10 16. Insurance Policies. The Corporation shall have the right from time to time to purchase, increase, modify or terminate insurance policies on the life of Executive for the benefit of the Corporation, in such amounts as the Corporation shall determine in its sole discretion. In connection therewith, Executive shall, at such time or times and at such place or places as the Corporation may reasonably direct, submit himself to such physical examinations and execute and deliver such documents as the Corporation may reasonably deem necessary or desirable. 17. Entire Agreement; Amendment. This Agreement constitutes the entire agreement of the parties hereto, and any prior agreement between the Corporation and Executive is hereby superseded and terminated effective immediately and shall be without further force or effect. No amendment or modification himself shall be valid or binding unless made in writing and signed by the party against whom enforcement thereof is sought. 18. Notices. Any notice required, permitted or desired to be given pursuant to any of the provisions of this Agreement shall be delivered in person or sent by responsible overnight delivery service or sent by certified mail, return receipt requested, postage and fees prepaid, if to the Corporation, at its address set forth above to the attention of the Corporation's Chief Financial Officer and, if to Executive, at his address set forth above. Either of the parties hereto may at any time and from time to time change the address to which notice shall be sent hereunder by notice to the other party given under this Paragraph 18. Notices shall be deemed effective upon receipt. 19. No Assignment; Binding Effect. Neither this Agreement, nor the right to receive any payments hereunder, may be assigned by either party without the other party's prior written consent. This Agreement shall be binding upon Executive, his heirs, executors and administrators and upon the Corporation, its successors and assigns. 20. Waivers. No course of dealing nor any delay on the part of either party in exercising any rights hereunder shall operate as a waiver of any such rights. No waiver of any default or breach of this Agreement shall be deemed a continuing waiver or a waiver of any other breach or default. 21. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, except that body of law relating to choice of laws. 22. Invalidity. If any clause, paragraph, section or part of this Agreement shall be held or declared to be void, invalid or illegal, for any reason, by any court of competent jurisdiction, such provision shall be ineffective but shall not in any way invalidate or affect any other clause, paragraph, section or part of this Agreement. 23. Further Assurances. Each of the parties shall execute such documents and take such other actions as may be reasonably requested by the other party to carry out the provisions and purposes of this Agreement in accordance with its terms. 24. Headings. The headings contained in this Agreement have been inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement. 25. Publicity. The Corporation and Executive agree that they will not make any press releases or other announcements prior to or at the time of execution of this Agreement with respect to the terms contemplated hereby, except as required by applicable law, without the prior approval of the other party, which approval will not be unreasonably withheld. 26. Arbitration. Any disputes arising under this Agreement shall be submitted to and determined by arbitration in New York City, New York; provided, however, that such arbitration shall be held in St. Louis, Missouri in the event that the Company's principal executive offices is located at the time of such dispute in St. Louis, Missouri. Such arbitration shall be conducted in accordance with the rules of the American Arbitration Association. Any award or decision of the arbitration shall be conclusive in the absence of fraud and judgment thereon may be entered in any court having jurisdiction thereof. The costs of such arbitration shall be paid by the non-prevailing party to the extent directed by the arbitrator(s). THIS AGREEMENT CONTAINS BINDING ARBITRATION PROVISIONS WHICH MAY BE ENFORCED BY THE PARTIES. 11 IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the day and year first above written. SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi -------------------------- George Lombardi Vice President and Chief Financial Officer /s/ David A. Byron ------------------- David A. Byron 12 EXHIBIT A-1 TO EMPLOYMENT AGREEMENT SHEFFIELD MEDICAL TECHNOLOGIES INC. 30 ROCKEFELLER PLAZA, SUITE 4515 NEW YORK, NEW YORK 10112 April 25, 1997 David A. Byron 17674 Lasiandra Drive Chesterfield, Missouri 63017 At a meeting of the Board of Directors of Sheffield Medical Technologies Inc. (the "Company") held on April 22, 1997, the Board authorized the grant to you of an option (the "Option") to purchase one hundred thousand (100,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company. The Option is being granted in connection with the Employment Agreement dated as of April 25, 1997 between the Company and you (the "Employment Agreement"). The terms of the Option are set forth below. 1. No part of the Option is currently exercisable. Subject to any adjustment pursuant to paragraph 5 below, the Option is exercisable at an exercise price of $2.75 per Share. Subject to the paragraph 2 below, the Option may first be exercised on April 25, 1998 for 10,000 Shares and shall become exercisable for an additional 10,000 Shares on each April 25 thereafter to and including April 25, 2007. Subject to paragraph 2 below, the Option must be exercised as to any and all Shares on or prior to April 25, 2007 (on which date the Option will, to the extent not previously exercised, expire). 2. Notwithstanding anything to the contrary contained herein or in the Plan (as defined below): (a) In the event your employment by the Company is terminated for Cause (as such term is defined in the Employment Agreement) prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date. The Option shall then expire to the extent not exercised within such 90 day period. (b) In the event that your employment by the Company is terminated by the Company for any reason other than for Cause, by you as a result of an Employer Breach (as such term is defined in the Employment Agreement) or by the Company by reason of your disability or death prior to the expiration of the Option, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (c) In the event that your employment by the Company is terminated by you for any reason other than an Employer Breach prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the second anniversary of the date of this letter, the Option shall become immediately exercisable for such 90 day period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such 90 day period. (d) In the event that your employment by the Company is terminated by the Company by reason of your death or disability, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (e) In the event of a Change of Control, the Option shall, at your option exercised by written notice delivered to the Company, become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. As used in this paragraph, "Change of Control" shall mean (i) the merger, consolidation or other business combination of the Company with or into another corporation with the effect that the shareholders of the Company immediately following the merger, consolidation or other business combination, hold 50% or less of the combined voting power of the then outstanding equity interests of the surviving corporation of such merger, consolidation or other business combination ordinarily (and apart from rights accruing under special circumstances) having the right to vote in the election of directors or (ii) the replacement of a majority of the Board of Directors of the Company in any given year as compared to the directors who constituted the Board at the beginning of such year, and such replacement shall not have been approved by the Board of Directors of the Company as constituted at the beginning of such year. If any of the options granted hereunder are treated as nonqualified stock options ("NQO") as the result of exceeding the $100,000 exercise limit contained in Section 422(d) of the Internal Revenue Code of 1986, as amended, the Company shall issue separate certificates representing those shares constituting incentive stock options ("ISO") and those shares constituting NQO's and shall identify the ISO shares as such on its stock transfer records. 3. Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the 13 Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. 4. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. 5. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the exercise price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. 6. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. 7. The Option does not confer upon you any right whatsoever as a stockholder of the Company. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, except as modified in accordance with the Plan by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding of the option, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi ---------------------------------- George Lombardi Chief Financial Officer AGREED TO AND ACCEPTED: /s/ David A. Byron - ------------------ David A. Byron 14 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Medical Technologies Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Medical Technologies Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated as of April 25, 1997, ________ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, ----------------------- David A. Byron 15 EXHIBIT A-2 TO EMPLOYMENT AGREEMENT SHEFFIELD MEDICAL TECHNOLOGIES INC. 30 ROCKEFELLER PLAZA, SUITE 4515 NEW YORK, NEW YORK 10112 April 25, 1997 David A. Byron 17674 Lasiandra Drive Chesterfield, Missouri 63017 At a meeting of the Board of Directors of Sheffield Medical Technologies Inc. (the "Company") held on April 22, 1997, the Board authorized the grant to you of an option (the "Option") to purchase one hundred thousand (150,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company. The Option is being granted in connection with the Employment Agreement dated as of April 25, 1997 between the Company and you (the "Employment Agreement"). The terms of the Option are set forth below. 1. No part of the Option is currently exercisable. Subject to any adjustment pursuant to paragraph 5 below, the Option is exercisable at an exercise price of $2.75 per Share. Subject to the paragraph 2 below, the Option may first be exercised on April 25, 1998 for 15,000 Shares and shall become exercisable for an additional 15,000 Shares on each April 25 thereafter to and including April 25, 2007. Subject to paragraph 2 below, the Option must be exercised as to any and all Shares on or prior to April 25, 2007 (on which date the Option will, to the extent not previously exercised, expire). 2. Notwithstanding anything to the contrary contained herein or in the Plan (as defined below): (a) In the event your employment by the Company is terminated for Cause (as such term is defined in the Employment Agreement) prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date. The Option shall then expire to the extent not exercised within such 90 day period. (b) In the event that your employment by the Company is terminated by the Company for any reason other than for Cause, by you as a result of an Employer Breach (as such term is defined in the Employment Agreement) or by the Company by reason of your disability or death prior to the expiration of the Option, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (c) In the event that your employment by the Company is terminated by you for any reason other than an Employer Breach prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the second anniversary of the date of this letter, the Option shall become immediately exercisable for such 90 day period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such 90 day period. (d) In the event that your employment by the Company is terminated by the Company by reason of your death or disability, the Option shall become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (e) In the event of a Change of Control, the Option shall, at your option exercised by written notice delivered to the Company, become immediately exercisable for one year as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. As used in this paragraph, "Change of Control" shall mean (i) the merger, consolidation or other business combination of the Company with or into another corporation with the effect that the shareholders of the Company immediately following the merger, consolidation or other business combination, hold 50% or less of the combined voting power of the then outstanding equity interests of the surviving corporation of such merger, consolidation or other business combination ordinarily (and apart from rights accruing under special circumstances) having the right to vote in the election of directors or (ii) the replacement of a majority of the Board of Directors of the Company in any given year as compared to the directors who constituted the Board at the beginning of such year, and such replacement shall not have been approved by the Board of Directors of the Company as constituted at the beginning of such year. If any of the options granted hereunder are treated as nonqualified stock options ("NQO") as the result of exceeding the $100,000 exercise limit contained in Section 422(d) of the Internal Revenue Code of 1986, as amended, the Company shall issue separate certificates representing those shares constituting incentive stock options ("ISO") and those shares constituting NQO's and shall identify the ISO shares as such on its stock transfer records. 3. Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the 16 Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. 4. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. 5. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the exercise price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. 6. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. 7. The Option does not confer upon you any right whatsoever as a stockholder of the Company. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, except as modified in accordance with the Plan by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding of the option, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi ----------------------------------- George Lombardi Chief Financial Officer AGREED TO AND ACCEPTED: /s/ David A. Byron --------------------- David A. Byron 17 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Medical Technologies Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Medical Technologies Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated as of April 25, 1997, ________ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- David A. Byron 18 EXHIBIT B TO EMPLOYMENT AGREEMENT SHEFFIELD MEDICAL TECHNOLOGIES INC. 30 ROCKEFELLER PLAZA, SUITE 4515 NEW YORK, NEW YORK 10112 April 25, 1997 David A. Byron 17674 Lasiandra Drive Chesterfield, Missouri 63017 At a meeting of the Board of Directors of Sheffield Medical Technologies Inc. (the "Company") held on April 22, 1997, the Board authorized the grant to you of an option (the "Option") to purchase one hundred and fifty (150,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company. The Option is being granted in connection with the Employment Agreement dated as of April 25, 1997 between the Company and you (the "Employment Agreement"). The terms of the Option are set forth below. 1. No part of the option is currently exercisable. Subject to any adjustment pursuant to paragraph 5 below, the Option is exercisable at an exercise price of $2.75 per Share. Subject to the paragraph 2 below, the Option may first be exercised on April 25, 1998 for 15,000 Shares and shall become exercisable for an additional 15,000 Shares on each April 25 thereafter to and including April 25, 2007. Subject to paragraph 2 below, the Option must be exercised as to any and all Shares on or prior to April 25, 2007 (on which date the Option will, to the extent not previously exercised, expire). 2. Notwithstanding anything to the contrary contained herein or in the Plan (as defined below): (a) In the event your employment by the Company is terminated for Cause (as such term is defined in the Employment Agreement) prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date. The Option shall then expire to the extent not exercised within such 90 day period. (b) In the event that your employment by the Company is terminated by the Company for any reason other than for Cause, by you as a result of an Employer Breach (as such term is defined in the Employment Agreement) or by the Company by reason of your disability or death prior to the expiration of the Option, the Option shall be exercisable for one year from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such one year period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (c) In the event that your employment by the Company is terminated by you for any reason other than an Employer Breach other than an Employer Breach prior to the expiration of the Option, the Option will be exercisable for 90 days from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such 90 day period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such 90 day period. (d) In the event that your employment by the Company is terminated by the Company by reason of your death or disability, the Option shall be exercisable for one year from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such one year period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. (e) in the event of a Change of Control, the Option shall, at your option exercised by written notice delivered to the Company, be exercisable for one year from the date of such termination, but only as to such Shares that had become exercisable pursuant to paragraph 1 above (and not previously purchased) prior to such date; provided, however, that if such termination occurs after the fifth anniversary of the date of this letter, the Option shall become immediately exercisable for such one year period as to all Shares not previously purchased. The Option shall then expire to the extent not exercised within such one year period. As used in this paragraph, "Change of Control" shall mean (i) the merger, consolidation or other business combination of the Company with or into another corporation with the effect that the shareholders of the Company immediately following the merger, consolidation or other business combination, hold 50% or less of the combined voting power of the then outstanding equity interests of the surviving corporation of such merger, consolidation or other business combination ordinarily (and apart from rights accruing under special circumstances) having the right to vote in the election of directors or (ii) the replacement of a majority of the Board of Directors of the Company in any given year as compared to the directors who constituted the Board at the beginning of such year, and such replacement shall not have been approved by the Board of Directors of the Company as constituted at the beginning of such year. 19 If any of the options granted hereunder are treated as nonqualified stock options ("NQO") as the result of exceeding the $100,000 exercise limit contained in Section 422(d) of the Internal Revenue Code of 1986, as amended, the Company shall issue separate certificates representing those shares constituting incentive stock options ("ISO") and those shares constituting NQO's and shall identify the ISO shares as such on its stock transfer records. 3. Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. 4. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement Under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold) ; (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. 5. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the exercise price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the option prior to the happening of any of the foregoing events. 6. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. 7. The Option does not confer upon you any right whatsoever as a stockholder of the Company. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the option, except as modified in accordance with the Plan by the terms set forth herein. A copy of the Plan has -been delivered to you with this letter. The option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding of the Option, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, SHEFFIELD MEDICAL TECHNOLOGIES INC. By: /s/ George Lombardi -------------------------------- George Lombardi Chief Financial Officer AGREED TO AND ACCEPTED: /s/ David A. Byron - ------------------------ David A. Byron 20 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Medical Technologies Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Medical Technologies Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated as of April 25, 1997, _________ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $______ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- David A. Byron 21 EXHIBIT C OPTION LETTER AGREEMENT DATED AUGUST 28, 1998 SHEFFIELD PHARMACEUTICALS, INC. 425 SOUTH WOODSMILL ROAD ST. LOUIS, MISSOURI 63017 August 28, 1998 To: David A. Byron 17674 Lasiandra Drive Chesterfield, Missouri 63017 At a meeting of the Stock Option Committee of the Board of Directors of Sheffield Pharmaceuticals, Inc. (the "Company") held on August 25, 1998, the Company authorized the grant to you as of the date hereof of an option (the "Option") to purchase one Hundred Fifty Five Thousand (105,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company (the "Common Stock"). No part of the option is currently exercisable. On or after August 28, 1999 and prior to August 28, 2008 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire), the Option may be exercised as follows: (i) as to 35,000 Shares, subsequent to the time that the Fair Market Value (as hereinafter defined) of the Common Stock equals or exceeds $1.2375 for 10 consecutive trading days (such Shares constituting the "First Tranche" of the Option); (ii) as to 35,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock equals or exceeds $2.125 for 10 consecutive trading days (such shares constituting the "Second Tranche" of the Option) and (iii) as to the remaining 35,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock exceeds $3.125 for 10 consecutive trading days (such Shares constituting the "Third Tranche" of the Option). As used herein, "Fair Market Value" means the closing price of the Common Stock on the principal U.S. national securities exchange on which the Common Stock is listed for trading (if the shares are so listed) or on the Nasdaq National Market or Small Cap Market (if the Common Shares are regularly quoted on the Nasdaq National Market or Small Cap Market), or, if not so listed or regularly quoted or if there is no such closing price, the mean between the closing bid and asked prices of the Common Stock on such exchange or on Nasdaq or in the over-the-counter market or, if such bid and asked prices shall not be available, as reported by any nationally recognized quotation service selected by the Company. Shares may be purchased by you upon exercise of the Option at the following respective purchase prices: (i) Shares constituting the First Tranche $1.2375 per Share; (ii) Shares constituting the Second Tranche $2.125 per Share; and (iii) Shares constituting the Third Tranche - $3.125 per Share. This Option must be exercised as to any and all Shares on or prior to August 28, 2008 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire). Notwithstanding anything to the contrary contained in this letter agreement, the following provisions shall apply: (a) In the event that Fair Market Value does not equal or exceed $1.2375 for 10 consecutive trading days prior to August 28, 2001 (the "Target Date"), the First Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the First Tranche will, to the extent not previously exercised, expire); (b) In the event that Fair Market Value does not equal or exceed $2.125 for 10 consecutive trading days prior to the Target Date, the Second Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the Second Tranche will, to the extent not previously exercised, expire); and 22 (c) In the event that Fair Market Value does not equal or exceed $3.125 for 10 consecutive trading days prior to the Target Date, the Third Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the Third Tranche will, to the extent not previously exercised, expire). Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this Option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the purchase price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. The Option does not confer upon you any right whatsoever as a stockholder of the Company. By accepting the Option, you acknowledge your agreement to advise the Company in writing at least five trading days prior to selling, assigning or otherwise transferring any of the Shares. The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is not intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, 23 except as modified by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, Sheffield Pharmaceuticals, Inc. By: /s/ Loren G. Peterson -------------------------------- Loren G. Peterson President and CEO AGREED TO AND ACCEPTED: /s/ David A. Byron ---------------------- David A. Byron 24 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Pharmaceuticals, Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Pharmaceuticals, Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated August 28, 1998, ______ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan, as amended. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, --------------------- David A. Byron 25 EXHIBIT D OPTION LETTER AGREEMENT DATED MARCH 1, 2000 SHEFFIELD PHARMACEUTICALS, INC. 425 SOUTH WOODSMILL ROAD ST. LOUIS, MISSOURI 63017 March 1, 2000 To: David A. Byron 17674 Lasiandra Drive Chesterfield, MO 63005 At a meeting of the Stock Option Committee of the Board of Directors of Sheffield Pharmaceuticals, Inc. (the "Company") held on February 29, 2000, the Company authorized the grant to you as of the date hereof of an option (the "Option") to purchase Ninety Thousand (90,000) shares (the "Shares") of Common Stock, par value $.01 per share, of the Company (the "Common Stock"). No part of the Option is currently exercisable. On or after March 1, 2001 and prior to March 1, 2010 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire), the Option may be exercised as follows: (i) as to 30,000 Shares, subsequent to the time that the Fair Market Value (as hereinafter defined) of the Common Stock equals or exceeds $4.75 for 10 consecutive trading days (such Shares constituting the "First Tranche" of the Option); (ii) as to 30,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock equals or exceeds $5.3125 for 10 consecutive trading days (such shares constituting the "Second Tranche" of the Option) and (iii) as to the remaining 30,000 Shares, subsequent to the time that the Fair Market Value of the Common Stock exceeds $6.3125 for 10 consecutive trading days (such Shares constituting the "Third Tranche" of the Option). As used herein, "Fair Market Value" means the closing price of the Common Stock on the principal U.S. national securities exchange on which the Common Stock is listed for trading (if the shares are so listed) or on the Nasdaq National Market or Small Cap Market (if the Common Shares are regularly quoted on the Nasdaq National Market or Small Cap Market), or, if not so listed or regularly quoted or if there is no such closing price, the mean between the closing bid and asked prices of the Common Stock on such exchange or on Nasdaq or in the over-the-counter market or, if such bid and asked prices shall not be available, as reported by any nationally recognized quotation service selected by the Company. Shares may be purchased by you upon exercise of the Option at the following respective purchase prices: (i) Shares constituting the First Tranche - - $4.75 per Share; (ii) Shares constituting the Second Tranche - $5.3125 per Share; and (iii) Shares constituting the Third Tranche - $6.3125 per Share. This Option must be exercised as to any and all Shares on or prior to March 1, 2010 (on which date the Option, to the extent it has not previously been exercised or has not previously expired, will expire). Notwithstanding anything to the contrary contained in this letter agreement, the following provisions shall apply: (a) In the event that Fair Market Value does not equal or exceed $4.75 for 10 consecutive trading days prior to March 1, 2003 (the "Target Date"), the First Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the First Tranche will, to the extent not previously exercised, expire); 26 (b) In the event that Fair Market Value does not equal or exceed $5.3125 for 10 consecutive trading days prior to the Target Date, the Second Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the Second Tranche will, to the extent not previously exercised, expire); and (c) In the event that Fair Market Value does not equal or exceed $6.3125 for 10 consecutive trading days prior to the Target Date, the Third Tranche of the Option may be exercised on the Target Date and for 60 days thereafter (after which 60th day the Option in respect of the Third Tranche will, to the extent not previously exercised, expire). Unless at the time of the exercise of the Option a registration statement under the Securities Act of 1933, as amended (the "Act"), is in effect as to such Shares, any Shares purchased by you upon the exercise of the Option shall be acquired for investment and not for sale or distribution, and if the Company so requests, upon any exercise of the Option, in whole or in part, you will execute and deliver to the Company a certificate to such effect. The Company shall not be obligated to issue any Shares pursuant to the Option if, in the opinion of counsel to the Company, the Shares to be so issued are required to be registered or otherwise qualified under the Act or under any other applicable statute, regulation or ordinance affecting the sale of securities, unless and until such Shares have been so registered or otherwise qualified. You understand and acknowledge that, under existing law, unless at the time of the exercise of the Option a registration statement under the Act is in effect as to such Shares (i) any Shares purchased by you upon exercise of this option may be required to be held indefinitely unless such Shares are subsequently registered under the Act or an exemption from such registration is available; (ii) any sales of such Shares made in reliance upon Rule 144 promulgated under the Act may be made only in accordance with the terms and conditions of that Rule (which, under certain circumstances, restrict the number of shares which may be sold and the manner in which shares may be sold); (iii) in the case of securities to which Rule 144 is not applicable, compliance with Regulation A promulgated under the Act or some other disclosure exemption will be required; (iv) certificates for Shares to be issued to you hereunder shall bear a legend to the effect that the Shares have not been registered under the Act and that the Shares may not be sold, hypothecated or otherwise transferred in the absence of an effective registration statement under the Act relating thereto or an opinion of counsel satisfactory to the Company that such registration is not required; and (v) the Company will place an appropriate "stop transfer" order with its transfer agent with respect to such Shares. In addition, you understand and acknowledge that the Company has no obligation to you to furnish information necessary to enable you to make sales under Rule 144. In the event that the Company shall at any time prior to the expiration of the Option and prior to the exercise thereof: (i) declare or pay to the holders of the Common Stock a dividend payable in any kind of shares of stock of the Company; or (ii) change or divide or otherwise reclassify its Common Stock into the same or a different number of shares with or without par value, or into shares of any class or classes; or (iii) consolidate or merge with, or transfer its property as an entirety or substantially all of its assets to any other corporation; or (iv) make any distribution of its assets to holders of its Common Stock as a liquidation, or partial liquidation dividend or by way of return of capital; then, upon the subsequent exercise of the Option, the purchase price of the Shares issuable upon the exercise hereof shall be appropriately adjusted by the Board of Directors of the Company so that you shall receive for the exercise price, in addition to or in substitution for the Shares to which you would be entitled upon such exercise, such additional shares of stock of the Company, or such reclassified shares of stock of the Company, or such securities or property of the Company resulting from such consolidation or merger or transfer, of such assets of the Company, which you would have been entitled to receive had you exercised the Option prior to the happening of any of the foregoing events. The Option (or installment thereof) is to be exercised by delivering to the Company a written notice of exercise in the form attached hereto as Annex A, specifying the number of Shares to be purchased, together with payment of the purchase price of the Shares to be purchased. The purchase price is to be paid in cash. The Option does not confer upon you any right whatsoever as a stockholder of the Company. By accepting the Option, you acknowledge your agreement to advise the Company in writing at least five trading days prior to selling, assigning or otherwise transferring any of the Shares. 27 The Option is granted to you under the Company's 1993 Stock Option Plan, as amended, (the "Plan") and is not intended to be an incentive stock option. The terms of the Plan are incorporated by reference into the Option, except as modified by the terms set forth herein. A copy of the Plan has been delivered to you with this letter. The Option shall be binding upon any successors or assigns of the Company. If the foregoing correctly sets forth our understanding, please indicate your acceptance by signing this letter in the space provided below. Very truly yours, Sheffield Pharmaceuticals, Inc. By: /s/ Loren G. Peterson -------------------------------- President AGREED TO AND ACCEPTED: /s/ David A. Byron ------------------ David A. Byron 28 Annex A STOCK SUBSCRIPTION FORM To: Sheffield Pharmaceuticals, Inc. Gentlemen: I hereby exercise my option to purchase from Sheffield Pharmaceuticals, Inc. (the "Company"), pursuant to the Stock Option Letter Agreement between us dated March 1, 2000, _______ shares of the Company's Common Stock, $.01 par value, and herewith tender payment therefor at the rate of $____ per share. The option was originally granted pursuant to the terms of the Company's 1993 Stock Option Plan, as amended. I represent and warrant that I am acquiring the said shares for my own account for investment purposes only; that I have no present intention of selling or otherwise disposing of such shares or any part thereof; that I will not transfer said shares in violation of the securities laws of the United States; that I am familiar with the business operations, management and financial condition and affairs of the Company; that I have not relied upon any representation of the Company with respect thereto; and that I have the personal financial means to comply with all of said representations. I further confirm that I have been advised that said shares will not be registered under the Securities Act of 1933, as amended, and that I have consulted with and been advised by counsel as to the restrictions on resale to which said shares will thereby be subject. The form in which I wish my name and address to appear on the Company's stock records is as follows: Name: ----------------------- Address: ----------------------- ----------------------- ----------------------- Very truly yours, ----------------------- David A. Byron 29 EXHIBIT E IRREVOCABLE PROXY The undersigned, David A. Byron ("Holder"), an individual with a residential address of 17674 Lasiandra Drive, Chesterfield, Missouri, 63017, hereby revokes any and all proxies heretofore granted with respect to any shares of common stock, $.01 par value (the "Stock"), of Sheffield Pharmaceuticals, Inc. ("Sheffield") held by Holder and, hereby irrevocably appoints the President of Sheffield, Loren G. Peterson, or his designee, and each of them, as attorney-in-fact and proxy of Holder to attend any and all meetings of the stockholders of Sheffield and to vote such Holder's Stock, to represent and otherwise to act for Holder in the same manner and with the same effect as if such Holder were personally present and to act by consent in the same manner and with the same effect as if Holder were executing such consent, with respect to any matter. Holder agrees that, so long as this Irrevocable Proxy remains in effect, Holder will not execute or deliver to any persons, any proxy forms relating to any meeting, or written consent in lieu of a meeting, of stockholders of Sheffield, will promptly provide Sheffield with copies of any communications related to Sheffield received by Holder and will not take any action inconsistent with this Irrevocable Proxy. The foregoing appointment shall be (a) absolute and irrevocable and (b) deemed coupled with an interest. This Irrevocable Proxy shall be effective for a period of one (1) year in accordance with Delaware law and may be relied upon by any third party. IN WITNESS WHEREOF, the undersigned Holder has executed this Irrevocable Proxy as of February 18, 2002. Witness: DAVID A. BYRON /s/ Sally Reiter /s/ David A. Byron - ------------------------------- ------------------------------- Witness print name: Sally Reiter ------------ 30 EXHIBIT F GENERAL RELEASE David A. Byron, in consideration of the good and valuable consideration contained in the attached Agreement ("the Agreement"), the receipt and sufficiency of which is hereby acknowledged, on behalf of himself, his heirs, administrators, representatives, executors, successors, and assigns, hereby irrevocably and unconditionally releases, acquits, and forever discharges Sheffield Pharmaceuticals, Inc. and its predecessors (including without limitation Sheffield Medical Technologies Inc.), parents, subsidiaries, affiliates, divisions, successors and assigns, and all of their current and former agents, officers, directors, employees, members, trustees, fiduciaries, representatives and attorneys (the "Released Parties") from any and all charges, complaints, claims, liabilities, obligations, promises, agreements, damages, causes of action, suits, demands, losses, debts, and expenses of any nature whatsoever, known or unknown ("Claims") which he has, had or claims to have against any Released Party up to and including the date he signs this General Release. This General Release of Claims shall include, without limitation, Claims relating to his employment and separation from employment with the Company, Claims of discrimination under the common law or any federal or state statute (including, without limitation, the Civil Rights Act of 1964, the Americans with Disabilities Act and the Age Discrimination in Employment Act, all as amended), Claims for wrongful discharge, Claims for the payment of any salary, wages, vacation time, bonuses or commissions, Claims for severance or other benefits (other than as specifically set forth in paragraphs 2, 3 and 4 of the Agreement), Claims of detrimental reliance, and all other statutory, common law or other Claims of any nature whatsoever. This General Release of Claims does not apply to any Claims concerning a breach of the Agreement, including the option letter agreements referred to in Paragraph 4 of the Agreement as amended by the Agreement, or any claims arising after the date you sign this General Release. With respect to the Claims being waived herein, Byron acknowledges that he is waiving his right to receive money or any other relief in any action instituted by him or on his behalf by any other person, entity or government agency. IN WITNESS WHEREOF, the undersigned David A. Byron has executed this General Release as of February 18, 2002. Witness: DAVID A. BYRON /s/ Sally Reiter /s/ David A. Byron - ------------------------------- ------------------------------- Witness print name: Sally Reiter ------------ 31 EXHIBIT G OLDER WORKERS BENEFIT PROTECTION ACT NOTICE TO EMPLOYEES AGE AND JOB TITLE INFORMATION In connection with the Agreement and the offer of benefits described therein, you are being provided with information as to (i) any class, unit or group of individuals covered by such offer; (ii) the job titles and ages of all individuals eligible or selected for the offer, and (iii) the ages of all individuals in the same job classification or organizational unit who are not eligible or selected for the offer. Eligible employees age forty (40) and over shall have forty-five (45) days to consider the Company's offer and may revoke their agreement to the offer within seven (7) days after their execution of the Agreement.
Departments or Ages of Employees Ages of Ineligible Units Affected Job Title Affected Employees - -------------- --------- ----------------- ------------------ Executive Officers Chairman 51 President and Chief 45 Executive Officer Executive Vice President, 58 Corporate Development Executive Vice President, 53 Scientific Affairs Vice President, Finance and 37 Administration and Chief Financial Officer Vice President, Pulmonary 48 Delivery Systems
32
EX-10.39 10 c68433ex10-39.txt INDEMNIFICATION AGREEMENT EXHIBIT 10.39 SHEFFIELD PHARMACEUTICALS, INC. INDEMNIFICATION AGREEMENT THIS INDEMNIFICATION AGREEMENT (the "Agreement") is made and entered into this 23rd day of January, 2002 by and between Sheffield Pharmaceuticals, Inc., a Delaware corporation (the "Company"), and the individuals listed on Schedule I hereto (each such individual an "Indemnitee" and collectively the "Indemnitees"): WHEREAS, qualified persons are reluctant to serve publicly-held corporations as directors or officers or in other capacities, unless they are provided with adequate protection against inordinate risks of claims and actions against them arising out of their service to and activities on behalf of such corporations; WHEREAS, the uncertainties related to obtaining adequate insurance and indemnification have increased the difficulty of attracting and retaining such quality persons; WHEREAS, it is reasonable, prudent and necessary for the Company to obligate itself contractually to indemnify such persons to the fullest extent permitted by law, so that such persons will serve or continue to serve the Company free from undue concern that they will not be adequately indemnified; WHEREAS, the Company and the Indemnitees recognize that the legal risks and potential liabilities, and the threat thereof, associated with lawsuits filed against persons serving the Company, and the resultant time, expense and anxiety spent and endured in defending lawsuits bears no reasonable relationship to the compensation received by such persons, and thus poses a significant deterrent and increased reluctance on the part of experienced and capable individuals to serve the Company; WHEREAS, the By-laws of the Company and the laws of the State of Delaware provide for the indemnification of directors, officers, agents and employees of the Company and specifically provide that they are not exclusive, and thereby contemplate that contracts may be entered into between the Company and persons providing services to it; and WHEREAS, the Indemnitees are willing to serve, continue to serve and to take on additional service for or on behalf of the Company on the condition that he be indemnified according to the terms of this Agreement; NOW, THEREFORE, in consideration of the premises and promises contained herein, the parties agree as follows: Section 1. Services by Indemnitee. Indemnitees agree to serve as directors and/or officers of the Company, and, with their subsequent consent, at the Company's request or for its benefit, as directors, officers, employees, agents or fiduciaries of certain other corporations and entities. Nothing contained herein shall entitle or require any Indemnitee to continue in his or her present position or any future position with the Company. Section 2. Term of Agreement. For any Indemnitee, this Agreement shall continue until and terminate upon the later of: (a) ten years after the date that such Indemnitee ceases to hold a Corporate Status or (b) 120 days after the final termination of all pending Proceedings in respect of which Indemnitee is granted rights of indemnification or advancement of Expenses hereunder and of any proceeding commenced by such Indemnitee pursuant to Section 8 of this Agreement. Section 3. Indemnification. 3.1 General. The Company shall hold harmless and indemnify the Indemnitees against all Liabilities and advance to the Indemnitees all Expenses to the fullest extent permitted by the General Corporation Law of the State of Delaware, or by any amendment thereof (but in the case of any amendment, only to the extent such amendment permits the Company to provide broader indemnification than provided prior to such amendment), or by other statutory provisions authorizing or permitting indemnification applicable from time to time hereafter. 3.2 Proceedings Other Than Proceedings by or in the Right of the Company. The Indemnitees shall be entitled to the rights of indemnification provided in this Section 3.2 if, by reason of an Indemnitee's Corporate Status, such Indemnitee is, or is threatened to be, made a party to any threatened, pending or completed Proceeding, other than a Proceeding by or in the right of the Company. Under this Section 3.2, any such Indemnitee shall be indemnified against all Liabilities actually and reasonably incurred by the Indemnitee or on the Indemnitee's behalf in connection with such Proceeding or any claim, issue or matter therein, if the Indemnitee acted in good faith and in a manner that the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company and, with respect to any criminal Proceeding, if the Indemnitee had no reasonable cause to believe the conduct was unlawful. 3.3 Proceedings by or in the Right of the Company. Each Indemnitee shall be entitled to the rights of indemnification provided in this Section 3.3, if, by reason of such Indemnitee's Corporate Status, the Indemnitee is, or is threatened to be, made a party to any threatened, pending or completed Proceeding 1 brought by or in the right of the Company to procure a judgment in its favor. Subject to the last sentence of this Section 3.3, any such Indemnitee shall be indemnified against all Liabilities actually and reasonably incurred by the Indemnitee or on the Indemnitee's behalf in connection with such Proceeding in good faith and in a manner that the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company. No indemnification of Liabilities shall be made in respect of any claim, issue or matter in such Proceeding as to which an Indemnitee shall have been adjudged to be liable to the Company unless and only to the extent that the Court of Chancery of the State of Delaware or the court in which such Proceeding was brought, determines such indemnification is proper. 3.4 Indemnification for Expenses as a Witness. Notwithstanding any other provision of this Agreement, to the extent that any Indemnitee is, by reason of such Indemnitee's Corporate Status, a witness in any Proceeding, he or she shall be indemnified against all Expenses actually and reasonably incurred by him or her or on his or her behalf in connection therewith. 3.5 Partial Indemnity. If an Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for some or a portion of any Liabilities but not, however, for all the total amount thereof, the Company shall nevertheless indemnify such Indemnitee for the portion thereof to which the Indemnitee is entitled. Moreover, notwithstanding any other provision of this Agreement, to the extent that an Indemnitee has been successful on the merits or otherwise in defense of any Proceeding or in defense of any claim, issue or matter therein, including dismissal without prejudice, such Indemnitee shall be indemnified against all Expenses incurred in connection therewith. Section 4. Advancement of Expenses. The Company shall advance all Expenses incurred or to be incurred by or on behalf of an Indemnitee in connection with any Proceeding within fifteen (15) days after the receipt by the Company of a statement from such Indemnitee requesting such advance from time to time, whether prior to or after final disposition of such Proceeding. Each statement shall reasonably evidence the Expenses incurred or to be incurred by the Indemnitee. The Indemnitee hereby undertakes to repay any Expenses so advanced if it shall ultimately be determined that the Indemnitee is not entitled to be indemnified against such Expenses. Section 5. Specific Limitations on Indemnity. No Indemnitee shall be entitled to indemnification under this Agreement: (a) In respect to remuneration paid to or advantage gained by such Indemnitee, if it shall be determined by final judgment or other final adjudication that such Indemnitee was not legally entitled to such remuneration or advantage; (b) On account of such Indemnitee's conduct which is finally adjudged to have been knowingly fraudulent, deliberately dishonest or willful misconduct; or (c) Prior to a Change in Control in respect of any Proceeding initiated by an Indemnitee against the Company or any director or officer of the Company, unless the Company has joined in or consented to the initiation of such Proceeding, except (i) as provided in Section 8 hereof, (ii) in respect of any counterclaims made against Indemnitee in any such Proceeding and (iii) to the extent Indemnitee seeks contribution or apportionment of an award or settlement against Indemnitee and against the Company and/or any other director or officer of the Company. Section 6. Procedure for Determination of Entitlement to Indemnification. 6.1 Initial Request. To obtain indemnification under this Agreement in connection with any Proceeding, and for the duration thereof, an Indemnitee shall submit to the Company a written request, including such documentation and information as is reasonably available to such Indemnitee and is reasonably necessary to 2 determine whether and to what extent the Indemnitee is entitled to indemnification. The Secretary of the Company shall, promptly upon receipt of any request for indemnification, advise the Board in writing that the Indemnitee has requested indemnification. 6.2 Method of Determination. Upon written request by an Indemnitee for indemnification pursuant to Section 6.1 hereof, a determination, if required by applicable law, with respect to the Indemnitee's entitlement thereto shall be made in such case: (a) if a Change in Control shall have occurred, by Independent Counsel (unless Indemnitee shall request that such determination be made by the Board of Directors or the stockholders, in which case in the manner provided for in clauses (b) or (c) of this Section 6.2) in a written opinion to the Board of Directors, a copy of which shall be delivered to the Indemnitee; (b) if a Change of Control shall not have occurred, (i) by the Board of Directors by a majority vote of a quorum consisting of Disinterested Directors, or (ii) if a quorum of the Board consisting of Disinterested Directors is not obtainable, or even if such quorum is obtainable, if such quorum of Disinterested Directors so directs, either (x) by Independent Counsel in a written opinion to the Board, a copy of which shall be delivered to the Indemnitee(s), or (y) by the stockholders of the Company, as determined by such quorum of Disinterested Directors, or a quorum of the Board, as the case may be; or (c) as provided in Section 7.2 of this Agreement. If it is determined that an Indemnitee is entitled to indemnification, payment to such Indemnitee shall be made within ten (10) days after such determination. 6.3 Selection, Payment and Discharge of Independent Counsel. If required, Independent Counsel shall be selected as follows: (a) if a Change of Control shall not have occurred, Independent Counsel shall be selected by the Board, and the Company shall give written notice to the Indemnitee advising him or her of the identity of Independent Counsel so selected; or (b) if a Change of Control shall have occurred, Independent Counsel shall be selected by the Indemnitee (unless the Indemnitee shall request that such selection be made by the Board, in which event clause (a) shall apply), and the Indemnitee shall give written notice to the Company advising it of the identity of Independent Counsel so selected. In either event, the Indemnitee or the Company, as the case may be, may, within seven (7) days after such written notice of selection shall have been given, deliver to the Company or to the Indemnitee, as the case may be, a written objection to such selection. Such objection may be asserted only on the ground that Independent Counsel so selected does not meet the requirements of "Independent Counsel" as defined in this Agreement, and the objection shall set forth with particularity the factual basis of such assertion. If such written objection is made, Independent Counsel so selected may not serve as Independent Counsel, unless and until a court has determined that such objection is without merit. If, within twenty (20) days after submission by the Indemnitee of a written request for indemnification pursuant to Section 6.1 hereof, no Independent Counsel shall have been selected and not objected to, either the Company or the Indemnitee may petition the Court of Chancery of the State of Delaware, or other court of competent jurisdiction, for resolution of any objection which shall have been made by the Company or by the Indemnitee to the other's selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by such court or by such other person as such court shall designate, and the person with respect to whom an objection is so resolved or the person so appointed shall act as Independent Counsel under Section 6.2 hereof. The Company shall pay any and all reasonable fees and expenses of Independent Counsel incurred by such Independent Counsel in connection with its actions pursuant to this Agreement, and the Company shall pay all reasonable fees and expenses incident to the procedures of this Section 6.3, regardless of the manner in which such Independent Counsel was selected or appointed. Upon the due commencement date of any judicial proceeding or arbitration pursuant to Section 8.1 of this Agreement, Independent Counsel shall be discharged and relieved of any further responsibility in such capacity (subject to the applicable standards of professional conduct then prevailing). 6.4 Cooperation. Both the Company and the Indemnitees shall cooperate with the person, persons or entity making the determination with respect to any Indemnitee's entitlement to indemnification, including providing to such person, persons or entity any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to the Indemnitees or to the Company, as the case may be, and reasonably necessary to such determination. Any reasonable costs or expenses (including attorneys' fees and disbursements) incurred by an Indemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determination as to the Indemnitee's entitlement to indemnification). Section 7. Presumptions and Effects of Certain Proceedings. 7.1 Burden of Proof. In making a determination with respect to entitlement to indemnification hereunder, the person, persons or entity making such determination shall presume that an Indemnitee is entitled to indemnification under this Agreement if the Indemnitee has submitted a request for indemnification in accordance with Section 6.1 of this Agreement, and the Company shall have the burden of proof to overcome that presumption in connection with the making by any person, persons or entity of any determination contrary to that presumption. 3 7.2 Failure to Determine Entitlement. If the person, persons or entity empowered or selected under Section 6 of this Agreement to determine whether the Indemnitee is entitled to indemnification shall not have made a determination within sixty (60) days after receipt by the Company of the request therefor, the requisite determination of entitlement to indemnification shall be deemed to have been made and the Indemnitee shall be entitled to such indemnification; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional thirty (30) days, if the person, persons or entity making the determination with respect to entitlement to indemnification in good faith require(s) such additional time for the obtaining or evaluating of documentation or information relating thereto; and provided, further, that the foregoing provisions of this Section 7.2 shall not apply if the determination of entitlement to indemnification is to be made by the stockholders pursuant to Section 6.2 of this Agreement and if (a) within fifteen (15) days after receipt by the Company of the request for such determination the Board has resolved to submit such determination to the stockholders for their consideration at an annual meeting thereof to be held within seventy-five (75) days after such receipt and such determination is made thereat, or (b) a special meeting of stockholders is called within fifteen (15) days after such receipt for the purpose of making such determination, such meeting is held for such purpose within sixty (60) days after having been so called and such determination is made thereat. 7.3 Effect of Other Proceedings. The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself adversely affect the right of an Indemnitee to indemnification or create a presumption (i) that an Indemnitee did not act in good faith and in a manner which such Indemnitee reasonably believed to be in or not opposed to the best interests of the Company or (ii) with respect to any criminal Proceeding, that the Indemnitee had reasonable cause to believe that the conduct was unlawful. Section 8. Remedies of Indemnitee. 8.1 Adjudication. In the event that (a) a determination is made pursuant to Section 6 of this Agreement that an Indemnitee is not entitled to indemnification under this Agreement, (b) advancement of Expenses is not timely made pursuant to Section 4 of this Agreement, (c) payment of indemnification is not made pursuant to Section 3 of this Agreement within ten (10) days after receipt by the Company of a written request therefor, or (d) payment of indemnification is not made within ten (10) days after a determination has been made that Indemnitee is entitled to indemnification or such determination is deemed to have been made pursuant to Sections 6 or 7 of this Agreement, such Indemnitee shall be entitled to an adjudication, in any court of competent jurisdiction and in a venue to be determined by the Indemnitee. Alternatively, an Indemnitee, at his or her option, may seek an award in arbitration to be conducted by a single arbitrator pursuant to the rules of the American Arbitration Association. Indemnitees shall commence any action under this Section 8.1 within 180 days following the date on which they first have the right to commence such action hereunder. 8.2 Good Faith. The Company hereby covenants and agrees to perform its obligations under this Agreement in good faith; and in any judgement or arbitration brought by an Indemnitee to enforce any such obligations the Company shall have the burden of establishing by a preponderance of the evidence that it (and its Board of Directors, if applicable) so performed such obligations and that the Indemnitee is not entitled to indemnification or the advancement of Expenses. 8.3 De Novo Review. In the event that a determination shall have been made pursuant to Section 6 of this Agreement that an Indemnitee is not entitled to indemnification, any judicial proceeding or arbitration commenced pursuant to Section 8.1 shall be conducted in all respects as a de novo trial or arbitration on the merits and such Indemnitee shall not be prejudiced by reason of that adverse determination. 8.4 Company Bound. If a determination shall have been made or deemed to have been made pursuant to Section 6 or 7 of this Agreement that an Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding or arbitration absent (a) a misstatement of a material fact by the Indemnitee, or an omission of a material fact necessary to make the Indemnitee's statement not materially misleading, in connection with the request for indemnification or the furnishing of information on (b) a prohibition of such indemnification under applicable law. The Company shall be precluded from asserting in any such judicial proceeding or arbitration that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any such arbitrator that the Company is bound by all provisions of this Agreement. 8.5 Expenses of Adjudication. In the event that an Indemnitee seeks an adjudication or an award to enforce his rights under, or to recover damages for breach of, this Agreement, such Indemnitee shall be entitled to recover from the Company, and shall be indemnified by the Company against, any and all expenses (of the type described in the definition of Expenses) actually and reasonably incurred by such Indemnitee in such adjudication or arbitration, 4 but only if the Indemnitee prevails therein. If it shall be determined in such adjudication or arbitration that an Indemnitee is entitled to receive part but not all of the indemnification or advancement of Expenses sought, such Indemnitee shall be entitled to recover expenses from the Company on a pro rata basis. Section 9. Non-Exclusivity; Subrogation. 9.1 Non-Exclusivity. The rights of indemnification and to receive advancement of Expenses as provided by this Agreement shall not be deemed exclusive of any other rights to which any Indemnitee may at any time be entitled under applicable law, the certificate of incorporation or by-laws of any corporation, any other agreement, a vote of stockholders, a resolution of directors or otherwise. 9.2 Subrogation. In the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of the Indemnitee(s), who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights. 9.3 No Duplicative Payment. The Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder if and to the extent that an Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise. Section 10. Insurance. The Company hereby covenants and agrees that, for each Indemnitee, for so long as such Indemnitee shall continue to serve as a director or officer of the Company (or shall continue at the request of the Company to serve as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise) and thereafter for so long as such Indemnitee shall be subject to any possible claim or threatened, pending or completed action, suit or proceeding, whether civil, criminal or investigative by reason of the fact that the Indemnitee was a director or officer of the Company (or served in any of said other capacities), the Company shall obtain and maintain in full force and effect for the benefit of such Indemnitee one or more valid, binding and enforceable policy or policies of directors' and officers' liability insurance ("D&O Insurance") in reasonable amounts from established and reputable insurers. Each Indemnitee shall be named as an insured in such a manner as to provide him or her the same rights and benefits as are accorded to the most favorably insured of the Company's directors, if the Indemnitee is a director; or of the Company's officers, if the Indemnitee is an officer but not a director of the Company; or of the Company's key employees, if the Indemnitee is not a director or officer but is a key employee. Notwithstanding the provisions of this Section 10, the Company shall have no obligation to obtain or maintain D&O Insurance for any Indemnitee, if the Company determines in good faith (i) that such insurance is not reasonably available, (ii) that the premium costs for such insurance are disproportionate to the amount of coverage provided, (iii) that the coverage provided by such insurance is limited by exclusion so as to provide an insufficient benefit, or (iv) that such Indemnitee is covered by similar insurance maintained by an affiliate of the Company. In the event that the Company does not purchase and maintain in effect said policy or policies of D & O Insurance pursuant to the provisions of this Section 10, the Company agrees to hold harmless and indemnify the Indemnitees to the full extent of the coverage which would otherwise have been provided for the benefit of such Indemnities pursuant to insurance policies held by the Company as of the Effective Date. If, at the time of the receipt of the notice of the commencement of a Proceeding, the Company has D&O Insurance in effect, the Company shall give prompt notice of the commencement of such Proceeding to the insurers in accordance with the procedures set forth in the applicable policy. The Company shall thereafter take all necessary or desirable action to cause such insurers to pay on behalf of the Indemnitee(s) all amounts payable as a result of such Proceeding in accordance with the terms of such policy. Section 11. Company May Assume Defense. In the event the Company shall be obligated to pay the Expenses of any Proceeding against an Indemnitee, the Company, if appropriate, shall be entitled to assume the defense of such Proceeding, with counsel reasonably acceptable to such Indemnitee, upon the delivery to the Indemnitee of written notice of its election to do so. After delivery of such notice, the Company shall not be liable to the Indemnitee under this Agreement for any fees of counsel subsequently incurred by the Indemnitee with respect to the same Proceeding; provided, however, that (a) the Indemnitee shall have the right to employ counsel in any such Proceeding at the Indemnitee's expense and (b) if (i) the employment of counsel by the Indemnitee has been previously authorized by the Company, (ii) the Indemnitee shall have reasonably concluded that there may be a conflict of interest between the Company and the Indemnitee in the conduct of any such defense, or (iii) the Company shall not, in fact, have employed counsel to assume the defense of such Proceeding, the fees and expenses of Indemnitee's counsel shall be at the expense of the Company. 5 Section 12. Definitions. For purposes of this Agreement: (a) "Change in Control" means a change in control of the Company occurring after the Effective Date of a nature that would be required to be reported in response to Item 6(e) of Schedule 14A of Regulation 14A (or in response to any similar item on any similar schedule or form) promulgated under the Securities Exchange Act of 1934 (the "act"), whether or not the Company is then subject to such reporting requirement; provided, however, that, without limitation, such a Change in Control shall be deemed to have occurred if after the Effective Date (i) any "person" (or as such term is used in Sections 13(d) and 14(d) of the Act) is or becomes the "beneficial owner" (as defined in Rule 13d-3 under the Act), directly or indirectly, of securities of the Company representing at least 20% or, in the case of Elan Corporation and its affiliates in the aggregate (collectively, the "Elan Group"), at least fifty (50%), of the combined voting power of the Company's then outstanding securities; (ii) approval by the stockholders of the Company of a merger or consolidation of the Company with any other company or plan of exchange involving the Company ("Merger"), other than (1) a Merger which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) more than fifty percent (50%) the combined voting power of the voting securities of the Company or such surviving entity outstanding immediately after the Merger, or (2) a Merger effected to implement a recapitalization of the Company (or similar transaction) in which no Person acquires twenty percent (20%) or more, or in the case of Elan Group in the aggregate, fifty percent (50%) or more, of the combined voting power of the Company's then outstanding securities; (iii) approval by the stockholders of the Company of a plan of complete liquidation of the Company or an agreement for the sale, lease, exchange or other transfer (in one transaction or a series of related transactions) or disposition by the Company of all or substantially all of the Company's assets (iv) at any time, during any period of two consecutive years, individuals who at the beginning of such period constituted the Board of Directors (including for this purpose any new director whose election or nomination for election by the Company's stockholders was approved by a vote of the directors then still in office who were directors at the beginning of such period) cease for any reason to constitute at least a majority of the Board of Directors. (b) "Corporate Status" means the position of a person as a director, officer, employee, agent or fiduciary of the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise held at the request of the Company and shall include any position which imposes duties on, or involves services by, such person with respect to an employee benefit plan, its participants or beneficiaries. (c) "Disinterested Director" means a director of the Company who is not and was not a party to the Proceeding in respect of which indemnification is sought by an Indemnitee. (d) "Effective Date" means the date of this Agreement. (e) "Expenses" means all reasonable attorneys' fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, and all other disbursements or expenses of the types of customarily incurred in connection with the prosecuting, defending, preparing to prosecute or defend, investigating, or being or preparing to be a witness in a Proceeding. (f) "Independent Counsel" means a law firm, or a member of a law firm, that is nationally recognized as experienced in matters of corporation law and neither presently is, not in the past five years has been, retained to represent either (i) the Company or Indemnitee in any matter material to either such party or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder. The term "Independent Counsel" shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or an Indemnitee in an action to determine an Indemnitee's rights under this Agreement. (g) "Liabilities" means any judgments, fines, penalties, or similar payments or amounts paid or incurred by an Indemnitee in connection with any Proceeding, and amounts paid or incurred by an Indemnitee or on an Indemnitee's behalf in settlement of any Proceeding (including any excise taxes or penalties assessed upon, or claimed against, an Indemnitee with respect to any employee benefit plan) and all Expenses. 6 (h) "Proceeding" means any action, suit, arbitration, alternate dispute resolution mechanism, investigation, administrative hearing or any other proceeding, pending or threatened, whether civil, criminal, administrative or investigative, except one initiated by an Indemnitee, unless the Board of Directors consents thereto. Section 13. Notices. All notices, requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given if (a) delivered by hand and receipted for by the party to whom such notice or other communication shall have been directed or (b) mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed: (a) If to an Indemnitee, to the address set forth for such Indemnitee upon Schedule I hereto. (b) If to the Company, to: Sheffield Pharmaceuticals, Inc. 14528 South Outer Forty Road Suite 205 St. Louis, MO 63017 Attention: Secretary or to such other address as may have been furnished to the other party. Promptly after receipt by an Indemnitee of notice of the commencement of or the threat of commencement of any Proceeding, such Indemnitee shall notify the Company of the commencement or the threat of commencement thereof. Section 14. General Provisions. 14.1 Successors and Assigns. This Agreement shall be binding upon the Company and its successors and assigns and shall inure to the benefit of the Indemnitees and their heirs, executors and administrators. The Company shall require and cause any successor to substantially all of the business or assets of the Company, by written agreement in form and substance satisfactory to a majority of the Indemnitees, expressly to assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place. 14.2 No Adequate Remedy. The parties acknowledge that it is impossible to measure in money the damages which will accrue to either party by reason of a failure to perform any of the obligations under this Agreement. Therefore, if either party shall institute any action or proceeding to enforce the provisions hereof, the party against whom such action or proceeding is brought hereby waives the claim or defense that the party bringing such action has an adequate remedy at law, and the party against whom the action is brought shall not urge in any action or proceeding the claim or defense that the other party has an adequate remedy at law. 14.3 Governing Law. This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of Delaware. 14.4 Severability. If any provision or provisions of this Agreement shall be held to be invalid or unenforceable for any reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of this Agreement (including, without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid or unenforceable) shall not in any way be affected or impaired thereby; and 9b) to the fullest extent possible, the remaining provisions of this Amendment (including, without limitation, each portion of any Section of this Agreement containing any such provision held to be invalid or unenforceable, that is not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested by the provision held invalid or unenforceable. 14.5 Modification and Waiver. No supplement, modification or amendment of this Agreement shall be binding unless executed in writing by the Company and a majority of the Indemnitees. No amendment, alteration, rescission or replacement of this Agreement or any provision hereof shall be effective as to any Indemnitee with respect to any action taken or omitted by such Indemnitee in any such Indemnitee's Corporate Status before such amendment, alteration, rescission or replacement. No waiver or any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provision hereof (whether or not similar) nor shall such waiver constitute a continuing waiver. No party shall be deemed to have waived a right or remedy provided in or relating to this Agreement, unless the waiver is in writing and duly executed by such party. 7 14.6 Entire Agreement. This Agreement as to its subject matter, exclusively and completely states the rights and duties of the parties, sets forth their entire understanding and merges all prior and contemporaneous representations, promises, proposes, discussions and understandings by or between the parties. [Signature Page Follows] 8 IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first written above. SHEFFIELD PHARMACEUTICALS, INC. INDEMNITEES By: /s/ Loren G. Peterson /s/ Thomas M. Fitzgerald ------------------------------------- ------------------------------------- Loren G. Peterson Thomas M. Fitzgerald President and Chief Executive Officer /s/ Loren G. Peterson -------------------------------------- Loren G. Peterson /s/ John M. Bailey -------------------------------------- John M. Bailey /s/ Digby W. Barrios -------------------------------------- Digby W. Barrios /s/ Todd C. Davis -------------------------------------- Todd C. Davis /s/ David A. Byron -------------------------------------- David A. Byron /s/ Carl F. Siekmann -------------------------------------- Carl F. Siekmann /s/ Scott A. Hoffmann ------------------------------------- Scott A. Hoffmann /s/ Thomas A. Armer ------------------------------------- Thomas A. Armer
9 SCHEDULE I LISTING OF INDEMNITEES
INDEMNITEE NOTICE ADDRESS ---------- -------------- Thomas M. Fitzgerald 4 St. Andrews Hill, Pittsford, NY 14534 Loren G. Peterson 1776 Stifel Lane Drive, Town & Country, MO 63017 John M. Bailey The Coach House, East Lane, Dedham Essex, UK, C07 6BL Digby W. Barrios 44 St. John's Road, Ridgefield, CT 06877 Todd C. Davis 445 Park Avenue, 11th Floor, New York, NY 10022 David A. Byron 17674 Lasiandra Dr., Chesterfield, MO 63301 Carl F. Siekmann 15915 Wetherburn Road Park, Chesterfield, MO 63017 Scott A. Hoffmann 17664 Wildridge Dr., Chesterfield, MO 63005 Thomas A. Armer 19000 Tilson Avenue, Cupertino, CA 95014
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EX-21 11 c68433ex21.txt SUBSIDIARIES EXHIBIT 21 SUBSIDIARIES OF SHEFFIELD PHARMACEUTICALS, INC.
Name Jurisdiction of Incorporation ---- ----------------------------- 1. Ion Pharmaceuticals, Inc. (100% owned subsidiary) Delaware 2. CP Pharmaceuticals, Inc. (100% owned subsidiary) Delaware 3. Systemic Pulmonary Delivery, Ltd. (100% owned subsidiary) Bermuda 4. Respiratory Steroid Delivery, Ltd. (80.1% owned subsidiary) Bermuda
EX-23.1 12 c68433ex23-1.txt CONSENT OF ERNST & YOUNG LLP EXHIBIT 23.1 CONSENT OF INDEPENDENT AUDITORS We consent to the incorporation by reference in the Registration Statements (Form S-3 No. 33-95732, Form S-3 No. 333-27753, Form S-3 No. 333-38327, and Form S-3 No. 333-54446) of Sheffield Pharmaceuticals, Inc. (the Company) and in the related Prospectuses and in the Registration Statements (Form S-8 No. 33-95262 and Form S-8 No. 333-14867) pertaining to the 1993 Stock Option Plan of Sheffield Pharmaceuticals, Inc., the 1993 Restricted Stock Plan of Sheffield Pharmaceuticals, Inc., the 1996 Directors Stock Option Plan of Sheffield Pharmaceuticals, Inc., and options granted to directors, officers, employees, consultants, and advisors of the Company pursuant to other employee benefit plans of Sheffield Pharmaceuticals, Inc. of our report dated February 12, 2002, with respect to the consolidated financial statements of Sheffield Pharmaceuticals, Inc. and Subsidiaries contained in the Annual Report on Form 10-K for the year ended December 31, 2001. /s/ Ernst & Young LLP St. Louis, Missouri March 28, 2002
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