-----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, OAidYVAzagrwrgcIrITVgpf58Q5uFzfcOcKEhT9njkm11Wayz7cV0E+sTg41vGQO FotXhy5Iu6/Pbyg1p1w4VA== 0000950123-06-002891.txt : 20060310 0000950123-06-002891.hdr.sgml : 20060310 20060309215642 ACCESSION NUMBER: 0000950123-06-002891 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20051231 FILED AS OF DATE: 20060310 DATE AS OF CHANGE: 20060309 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DUSA PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000879993 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 223103129 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31533 FILM NUMBER: 06677453 BUSINESS ADDRESS: STREET 1: 25 UPTON DRIVE CITY: WILMINGTON STATE: MA ZIP: 01887 BUSINESS PHONE: 9786577500 MAIL ADDRESS: STREET 1: 25 UPTON DRIVE CITY: WILMINGTON STATE: MA ZIP: 01887 FORMER COMPANY: FORMER CONFORMED NAME: DEPRENYL USA INC / NJ DATE OF NAME CHANGE: 19930328 10-K 1 y18270e10vk.txt FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (MARK ONE) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2005 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________ TO ____________ COMMISSION FILE NUMBER 001-31533 DUSA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) NEW JERSEY 22-3103129 (State or other jurisdiction of (I.R.S. Employer Incorporation or organization) Identification No.) 25 Upton Drive, Wilmington, MA 01887 (Address of principal executive offices) (Zip Code) REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (978) 657-7500 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: (TITLE OF CLASS) NONE SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: (TITLE OF CLASS) COMMON STOCK, NO PAR VALUE Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ ] No [X] Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act Yes [ ] No [X] 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 of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer (as defined in Rule 12b-2 of the Act). Large Accelerated Filer [ ] Accelerated Filer [X] Non-accelerated Filer [ ] Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X] As of March 6, 2006, the registrant had 17,046,197 shares of Common Stock, no par value, outstanding. Based on the last reported sale price of the Company's common stock on the NASDAQ National Market on June 30, 2005 ($9.30) (the last business day of the registrant's most recently completed second fiscal quarter), the aggregate market value of the voting stock held by non-affiliates of the registrant was approximately $100,843,825. DOCUMENTS INCORPORATED BY REFERENCE
Document Description 10-K Part III - -------------------------------------------------------- -------------------- Portions of the Registrant's proxy statement to be filed Items 10, 11, 12, 13 pursuant to Regulation 14A within 120 days after and 14 Registrant's fiscal year end of December 31, 2005 are incorporated by reference into Part III of this report.
PART I This Annual Report on Form 10-K and certain written and oral statements incorporated herein by reference of DUSA Pharmaceuticals, Inc. (referred to as "DUSA," "we," and "us") contain forward-looking statements that have been made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about DUSA's industry, management's beliefs and certain assumptions made by our management. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words and similar expressions, are intended to identify such forward-looking statements. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict particularly in the highly regulated pharmaceutical industry in which we operate. Therefore, actual results may differ materially from those expressed or forecasted in any such forward-looking statements. Such risks and uncertainties include those set forth herein under "Risk Factors" on pages 26 through 38, as well as those noted in the documents incorporated herein by reference. Unless required by law, we undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. However, readers should carefully review the statements set forth in other reports or documents we file from time to time with the Securities and Exchange Commission, particularly the Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K. 2 ITEM 1. BUSINESS GENERAL DUSA Pharmaceuticals, Inc. (referred to as "DUSA," "we," and "us") is a pharmaceutical company engaged primarily in the research, development and marketing of our first drug in combination with light devices to treat or detect a variety of conditions in processes known as photodynamic therapy or photodetection. Our drug, Levulan(R) brand of aminolevulinic acid HCl, or ALA, is being used with light, for use in a broad range of medical conditions. When we use Levulan(R) and follow it with exposure to light to treat a medical condition, it is known as Levulan(R) photodynamic therapy, or Levulan(R) PDT. When we use Levulan(R) and follow it with exposure to light to detect medical conditions it is known as Levulan(R) photodetection, or Levulan(R) PD. Our products, the Levulan(R) Kerastick(R) 20% Topical Solution with PDT and the BLU-U(R) brand light source were launched in the United States, or U.S., in September 2000 for the treatment of actinic keratoses, or AKs, of the face or scalp. AKs are precancerous skin lesions caused by chronic sun exposure that can develop over time into a form of skin cancer called squamous cell carcinoma. In addition, in September 2003 we received clearance from the U.S. Food and Drug Administration, or FDA, to market the BLU-U(R) without Levulan(R) PDT for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions. We are a vertically integrated company, primarily responsible for regulatory, sales, marketing, customer service, manufacturing of our Kerastick(R), and other related product activities. Our objectives include increasing the sales of our approved products in the U.S. and Canada, continuing our efforts of exploring partnership opportunities for Levulan(R) PDT for dermatology in Europe and/or other countries outside of the U.S., Canada and Latin America, and continuing our clinical development programs for our facial photodamage and moderate to severe acne indications. In January 2006, we entered into a marketing and distribution agreement with Stiefel Laboratories, Inc. granting Stiefel an exclusive right to distribute the Levulan(R) Kerastick(R) in Mexico, Central and South America. We have also signed clinical trial agreements with the National Cancer Institute, or NCI, Division of Cancer Prevention, or DCP, for the clinical development of Levulan(R) PDT for the treatment of high-grade dysplasia, or HGD, within Barrett's Esophagus, or BE, and oral cavity dysplasia treatment, and are working with the NCI DCP to advance the development of these programs. In addition, we continue to support independent investigator trials to advance research in the use and applicability of Levulan(R) PDT for other indications in dermatology, and selected internal indications. See sections entitled "Business - - Internal Indications" and "Business - Distribution". We are developing Levulan(R) PDT and PD under an exclusive worldwide license of patents and technology from PARTEQ Research and Development Innovations, the licensing arm of Queen's University, Kingston, Ontario, Canada. We also own or license certain other patents relating to methods for using pharmaceutical formulations which contain our drug and related processes and improvements. In the United States, DUSA(R), DUSA Pharmaceuticals, Inc.(R), Levulan(R), Kerastick(R) and BLU-U(R) are registered trademarks. Several of these trademarks are also registered in Europe, Australia, Canada, and in other parts of the world. Numerous other trademark applications are pending. See sections entitled "Business - Licenses; and - Patents and Trademarks". On December 30, 2005, we entered into a merger agreement, (the "Merger Agreement"), to acquire all of the common stock of Sirius Laboratories, Inc. of Vernon Hills, Illinois in exchange for cash and common stock of DUSA worth up to $30,000,000. Of the up to $30,000,000, $8,000,000 less certain expenses will be paid in cash upon closing, $17,000,000 will be paid in shares of DUSA's common stock 3 also upon closing, and up to $5,000,000 in cash or common stock may be paid based on a combination of new product approvals or launches, and achievement of certain pre-determined total cumulative sales milestones for Sirius products. The products acquired in this transaction, called the Sirius Merger, focus primarily on the treatment of acne vulgaris and acne rosacea. We expect that the DUSA shares will be issued pursuant to Regulation D. Further, the Merger Agreement provides for certain conditions precedent to closing, including, but not limited to, (i) the approval of the transaction and the terms and conditions of the Merger Agreement by the Sirius shareholders, (ii) the receipt by DUSA of audited financial statements of Sirius for the fiscal years ended 2003, 2004 and 2005, and (iii) the determination by DUSA that the third party manufacturing and distribution facilities used by Sirius to manufacture or distribute its products, as the case may be, are in material compliance with all applicable legal requirements and that the third party manufacturing facilities have the reasonable capability of continuing to manufacture Sirius' products in compliance with cGMP. In addition, the Merger Agreement provides DUSA, Sirius and certain Sirius shareholders with the right to terminate the Merger Agreement under certain circumstances. The parties have also made customary representations, warranties and covenants in the Merger Agreement. The closing of the transaction is expected during the first quarter of 2006, subject to the terms and conditions in the Merger Agreement. We were incorporated on February 21, 1991, under the laws of the State of New Jersey. Our principal executive offices are located at 25 Upton Drive, Wilmington, Massachusetts 01887 (telephone: (978) 657-7500). On March 3, 1994, we formed DUSA Pharmaceuticals New York, Inc., a wholly owned subsidiary located in Valhalla, New York, to coordinate our research and development efforts. We have financed our operations to date, primarily from sales of our products, sales of securities in public offerings, private and offshore transactions that are exempt from registration under the Securities Act of 1933, as amended, (the "Act"), including a private placement under Regulation D of the Act which was consummated on February 27, 2004, and from payments received as part of the agreement with our former marketing collaborator. See sections entitled "Management's Discussion and Analysis of Financial Condition - Overview; - Results of Operations; and - Liquidity and Capital Resources". BUSINESS STRATEGY The key elements of our strategy include the following: o Expand the Marketing and Sales of our Products. In 2005, DUSA expanded its direct sales force to 24 representatives by year-end and launched various marketing initiatives, which increased revenues. o Physician Education Support. DUSA supports various physician education activities, including financial support for independent medical education programs, participation in dermatological conferences, and support for independent investigator studies that could lead to new scientific papers and/or presentations. o Leveraging our Levulan(R) PDT/PD Platform to Develop Additional Products. During 2005, we conducted Phase II multi-center clinical trials in the United States to determine the safety and efficacy of Levulan(R) PDT in the treatment of facial photodamage and moderate to severe inflammatory acne. If we are able to obtain FDA approval, there may be significant additional market opportunities for our products. We are also actively marketing the BLU-U(R) without Levulan(R), to treat moderate inflammatory acne vulgaris, which supports a multi-use capability of our BLU-U(R), in addition to its use in our 4 approved AK therapy. Outside of dermatology, we are developing Levulan(R) products for the treatment of high-grade dysplasia in patients with Barrett's esophagus, both independently and in co-operation with the NCI DCP, and for oral cavity dysplasia treatment (with the NCI DCP) See sections entitled "Internal Indications - Barrett's Esophagus Dysplasia; and - Oral Cavity Dysplasia". o Enter into Additional Strategic Alliances. If we determine that the development program for a given indication may be beyond our own resources or may be advanced to market more rapidly by collaborating with a corporate partner, we may seek opportunities to license, market or co-promote our products. We are currently exploring opportunities to develop, market, and distribute our Levulan(R) PDT platform in Europe and/or other countries outside of the United States, Canada and Latin America following our recently completed agreement with Stiefel Laboratories, Inc. We are also continuing to seek to acquire and/or license additional dermatology products that complement our current products, that would provide our sales force with additional synergistic products to sell in the near term. o Use the Results of Independent Researchers to Identify New Applications. We continue to work closely with and support research by independent investigators so that we have the benefit of the resulting `anecdotal' human data for use in evaluating potential indications for corporate development. We also continue to monitor independent research in order to identify other potential new indications. o Improve Third-party Reimbursement for our Products. DUSA plans to continue to support activities to improve and/or pursue third-party reimbursement for our products. PDT/PD OVERVIEW In general, both photodynamic therapy and photodetection are two-step processes: o The first step is the application of a drug known as a "photosensitizer," or a pre-cursor of this type of drug, which tends to collect in specific cells. o The second step is activation of the photosensitizer by controlled exposure to a selective light source in the presence of oxygen. During this process, energy from the light activates the photosensitizer. In PDT, the activated photosensitizer transfers energy to oxygen molecules found in cells, converting the oxygen into a highly energized form known as "singlet oxygen," which destroys or alters the sensitized cells. In PD, the activated photosensitizer emits energy in the form of light, making the sensitized cells fluoresce, or "glow". The longer the wavelength of visible light, the deeper into tissue it penetrates. Different wavelengths, or colors of light, including red and blue light, may be used to activate photosensitizers. The selection of the appropriate color of light for a given indication is primarily based on two criteria: o the desired depth of penetration of the light into the target tissue, and o the efficiency of the light in activating the photosensitizer. 5 Blue light does not penetrate deeply into tissues, so it is generally better suited for treating superficial lesions. However, it is also a potent activator of some photosensitizers, including ours. Red light penetrates more deeply into tissues, and is therefore generally better suited for treating cancers and deeper tissues. However, it is generally not as strong an activator of photosensitizers, including ours. Different photosensitizers do not absorb all wavelengths (colors) of visible light in the same manner. For any given photosensitizer, some colors are more strongly absorbed than others. Another consideration in selecting a light source is the location of the target tissue. Lesions on the skin which are easily accessible can be treated with either laser or non-laser light sources. Internal indications, which are often more difficult to access, usually require lasers in order to focus light into small fiber optic delivery systems that can be passed through an endoscope or into hollow organs. PDT can be a highly selective treatment that targets specific tissues while minimizing damage to normal surrounding tissues. It also can allow for multiple courses of therapy. The most common side effect of photosensitizers that are applied topically or taken systemically is temporary skin sensitivity to bright light. Patients undergoing PDT and PD treatments are usually advised to avoid direct sunlight and/or to wear protective clothing during this period. Patients' indoor activities are generally unrestricted except that they are told to avoid bright lights. The degree of selectivity and period of skin photosensitivity varies among different photosensitizers and is also related to the drug dose given. Unless activated by light, photosensitizers have no direct PDT/PD effects. OUR LEVULAN(R) PDT/PD PLATFORM OUR LEVULAN(R) BRAND OF ALA We have a unique approach to PDT and PD, using the human cell's own natural processes. Levulan(R) PDT takes advantage of the fact that ALA is the first product in a natural biosynthetic pathway present in virtually all living human cells. In normal cells, the production of ALA is tightly regulated through a feedback inhibition process. In our PDT/PD system, excess ALA (as Levulan(R)) is added from outside the cell, bypassing this normal feedback inhibition. The ALA is then converted through a number of steps into a potent natural photosensitizer named protoporphyrin IX, or PpIX. This is the compound that is activated by light during Levulan(R) PDT/PD, especially in fast growing cells. Any PpIX that remains after treatment is eliminated naturally by the same biosynthetic pathway. We believe that Levulan(R) is unique among PDT/PD agents. It has the following features: o Naturally Occurring. ALA is a naturally occurring substance found in virtually all living human cells. o Small Molecule. Levulan(R) is a small molecule that is easily absorbed whether delivered topically, orally, or intravenously. o Highly Selective. Levulan(R) is not itself a photosensitizer, but is a pro-drug that is converted through a cell-based process into the photosensitizer PpIX. The combination of topical application, tissue specific uptake, conversion into PpIX and targeted light delivery make this a highly selective process. Therefore, under appropriate conditions, we can achieve selective clinical effects in targeted tissues with minimal effects in normal surrounding and underlying tissues. o Controlled Activation. Levulan(R) has no PDT effect without exposure to light at specific wavelengths, so the therapy is easily controlled. 6 Scientists believe that the accumulation of PpIX following the application of Levulan(R) is more pronounced in: o rapidly growing diseased tissues, such as precancerous and cancerous lesions, o conditions characterized by rapidly proliferating cells such as those found in psoriasis and certain microbes, and o in certain normally fast-growing tissues, such as hair follicles, sebaceous glands, esophageal mucosa and the lining of the uterus. OUR KERASTICK(R) BRAND APPLICATOR We designed our proprietary Kerastick(R) specifically for use with Levulan(R). It is a single-use, disposable applicator, which allows for the rapid preparation and uniform application of Levulan(R) topical solution in standardized doses. The Kerastick(R) has two separate glass ampoules, one containing Levulan(R) powder and one containing a liquid vehicle, both enclosed within a single plastic tube and an outer cardboard sleeve. There is a filter and a metered dosing tip at one end. Prior to application, the doctor or nurse crushes the ampoules and shakes the Kerastick(R) according to directions to mix the contents into a solution. The Kerastick(R) tip is then dabbed onto the individual AK lesions, releasing a predetermined amount of Levulan(R) 20% topical solution. OUR LIGHT SOURCES Customized light sources are critical to successful Levulan(R) PDT/PD because the effectiveness of Levulan(R) therapy depends on delivering light at an appropriate wavelength and intensity. We intend to continue to develop combination drug and light device systems, in which the light sources: o are compact and tailored to fit specific medical needs, o are pre-programmed and easy to use, and o provide cost-effective therapy. Our proprietary BLU-U(R) is a continuous-wave (non-pulsed) fluorescent light source that can treat the entire face or scalp at one time. The light source is reasonably sized and can be moved from room to room if necessary. It can be used in a physician's office, requires only a moderate amount of floor space, and plugs into a standard electrical outlet. The BLU-U(R) also incorporates a proprietary regulator that controls the optical power of the light source to within specified limits. It has a simple control panel consisting of an on-off key switch and digital timer which turns off the light automatically at the end of the treatment. The BLU-U(R) is also compliant with CE marking requirements. We believe non-laser, non-pulsed light sources in comparison to lasers and high-intensity pulsed light sources, are: o safer, o simpler to use, o more reliable, and o far less expensive. 7 For treatment of AKs, our BLU-U(R) uses blue light which is a potent activator of PpIX and does not penetrate deeply into the skin. Longer red wavelengths penetrate more deeply into tissue but are not as potent activators of PpIX. Therefore, for treatment of superficial lesions of the skin, such as AKs, we are using our relatively low intensity, non-laser, non-pulsed BLU-U, which is designed to treat areas such as the face or scalp. For treatment of diseases that may extend several millimeters into the skin or other tissues, including many forms of cancer; high-powered red light is usually preferable. We have also received clearance from the FDA to market the BLU-U(R) without Levulan(R) for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions. We are also evaluating whether to develop and/or license additional light devices for use with Levulan(R). During 2005, we studied the use of Levulan(R) with three different light devices, including our BLU-U for the repair of facial photodamage. Also in 2005, we continued the study of our new proprietary endoscopic light delivery system in a small Phase II single-center clinical study of the efficacy and safety of Levulan(R) PDT for the treatment of high grade dysplasia in patients with Barrett's esophagus. Our new system is designed to ease the process by which physicians place fiber optics used for endoscopic light delivery within hollow target organs such as the esophagus. See sections entitled "Business-Dermatology Indications, Facial Photodamage and Internal Indications, Barrett's Esophagus Dysplasia". OUR PRODUCTS The following table outlines our Levulan(R) and BLU-U(R) products and currently planned product candidates. Our product sales for the last three years were $11,337,461 in 2005, $7,987,656 in 2004, and $970,109 in 2003. Our research and development expenses for the last three years were $5,587,599 in 2005, $6,489,723 in 2004, and $5,403,961 in 2003.
STATUS OF REGULATORY INDICATION/PRODUCT STUDIES - ------------------ -------------------------- DERMATOLOGY Levulan(R) Kerastick(R) and BLU-U(R) for PDT of AKs Approved Levulan(R) PDT for Photodamaged Skin Phase II(1) Levulan(R) PDT for Moderate to Severe Acne Vulgaris Phase II(2) BLU-U(R) Treatment of Moderate Inflammatory Acne Vulgaris and general dermatological conditions Without Levulan(R) Market Clearance(3) OTHER INDICATIONS Levulan(R) PDT for Barrett's Esophagus Dysplasia using DUSA(R) Endoscopic Light Delivery System Phase I/II(4), (5) Levulan(R) Induced Fluorescence Guided Resection for Brain Cancer European Phase III(6), (7) Levulan(R) Oral Cavity Dysplasia Phase I/II(8)
- ---------- 1 Phase II clinical trial interim results were released in the first quarter of 2006 2 Phase II clinical trial results were released in the first quarter of 2006 3 In September 2003, the FDA provided market clearance 4 Phase II single-center clinical trial initiated in second quarter 2004 using DUSA's new endoscopic light delivery device. All patients have been accrued and treated and follow-up is continuing. 5 Phase II clinical trial planned to be initiated with the NCI DCP in 2005 is still in process of protocol finalization. Initiation is expected in 2006. 6 Licensed from photonamic GmbH & Co. KG 7 European Phase III clinical trial results are not expected to be suitable for NDA filing in the United States. 8 8 Phase I/II clinical trial planned to be initiated with the NCI DCP in 2005. Protocol finalization continuing and initiation is expected during 2006. DERMATOLOGY INDICATIONS We have been responsible for our Levulan(R) dermatology research and development programs since reacquiring our product rights in late 2002 from a former strategic alliance partner. We have focused on completing our AK post approval development program, and have commenced Phase II clinical programs examining the safety and efficacy of Levulan(R) PDT for the treatment of photodamaged skin and moderate to severe acne vulgaris which, if successfully developed through FDA approval, could lead to additional dermatological indications and significant market opportunities. The results of our Phase II trials were announced in early 2006. DUSA also continues to support a wide range of independent investigator studies using the Levulan(R) Kerastick(R) that could lead to additional new indications for future development. Actinic Keratoses. AKs are superficial precancerous skin lesions usually appearing in sun-exposed areas as rough, scaly patches of skin with some underlying redness. The traditional methods of treating AKs are cryotherapy, or the deep freezing of skin, using liquid nitrogen; 5-fluorouracil cream, or 5-FU; and surgery, for especially thick or suspicious lesions. In recent years, imiquimod and diclofenac have also been used for the treatment of AKs. Although any of these methods can be effective, each has limitations and can result in significant side effects. Cryotherapy is non-selective, is usually painful at the site of freezing and can cause blistering and loss of skin pigmentation, leaving permanent white spots. In addition, because there is no standardized treatment protocol, results are not uniform. 5-FU can be highly irritating and requires twice-a-day application by the patient for approximately 2 to 4 weeks, resulting in inflammation, redness and erosion or rawness of the skin. Following the treatment, an additional 1 to 2 weeks of healing is required. Surgery is generally most useful for one or a few individual lesions, but not large numbers of lesions, and leaves permanent scars. Imiquimod or diclofenac require extended applications of cream, lasting up to 3 or 4 months, during which the skin is often very red and inflamed. Our approved treatment method involves applying Levulan(R) 20% topical solution using the Kerastick(R) to individual AK lesions, followed 14 to 18 hours later with exposure to our BLU-U(R) for approximately 17 minutes. In our Phase III trials, using this overnight drug application, our treatment was painful, but generally well tolerated. Resulting redness and/or inflammation generally resolved within days without any change in pigmentation. Facial Photodamaged Skin. Photodamaged skin, which is skin damaged by the sun, occurs primarily in fair-skinned individuals after many years of sun exposure. Signs of photodamaged skin include roughness, wrinkles and brown spots. AKs also occur frequently in areas of photodamaged skin. There are numerous consumer cosmetic and herbal products which claim to lessen or relieve the symptoms of photodamaged skin. In most cases, there is little scientific data to support these claims. The FDA has approved only one prescription drug, Renova(R)(1), to treat this common skin condition. Patients generally use the product for between six and 24 weeks before improvement may be observed. There are also a number of FDA approved laser and light-based treatments being used in the treatment of photodamaged skin. As part of our AK clinical trials, we conducted a Phase II safety and efficacy study, testing 64 patients with 3 to 7 AK lesions of the face or scalp within an area of photodamaged skin. The physician - ---------- (1) Renova(R) is a registered trademark of Johnson & Johnson. 9 investigators applied Levulan(R) 20% topical solution over the entire area including the photodamaged skin. After 14 to 18 hours, the patients were treated with blue light at differing light doses. Investigators noted marked improvement in skin roughness in the treated areas in two-thirds of the patients after treatment with Levulan(R) PDT as well as some degree of improvement of wrinkles and brown spots. However, 10 of the 64 patients found that the burning and stinging of the PDT therapy was too uncomfortable and as a result the treatment was either terminated early or the light power was reduced. No patients reported a serious treatment-related adverse event. During 2003, DUSA-supported independent investigator studies for photodamaged skin were completed, including short incubation studies using different light sources: a BLU-U(R), pulsed dye lasers, and intense pulsed light sources. Data from some of the independent investigator studies were used to help determine the method of treatment for the Phase II study mentioned below. According to peer-reviewed publications, these studies reported that, when Levulan(R) is applied to the entire face for as little as one hour followed by treatment with the BLU-U(R), or pulsed light sources, efficacy in removing AKs is similar to that of our Phase III trials, which used spot application on each AK and overnight incubation. Additionally, these studies report that patients' skin have showed improvements in various photodamaged skin parameters, including skin quality, sallowness, roughness, fine wrinkling, and Griffiths score, a photonumeric scale for the assessment of skin photodamage. Investigator studies have been published reporting that IPL plus Levulan(R) results in a "photodynamic photorejuvenation" which enhances the results of IPL alone. Published investigator studies have also reported that the LPDL together with Levulan(R) can successfully remove AKs, and improve photodamage as well as treat sebaceous gland hyperplasia (indications which the LPDL alone was unable to treat). The positive results of an independent investigator prospective, randomized, controlled split face clinical study using Levulan(R) photodynamic therapy, together with intense pulsed light for the treatment of photodamaged skin, were published in the October 2005 issue of the American Medical Association Journal Archives of Dermatology. In February, 2006 we reported the interim analysis results from our 80 patient, multi-center Phase II split-face clinical study of photodynamic therapy (PDT) in the treatment of photodamaged skin using the Levulan(R) (aminolevulinic acid HCl, ALA) Kerastick(R) in combination with either the Company's BLU-U(R), an Intense Pulsed Light (`IPL'), or a Long Pulsed Dye Laser (`LPDL'). Each patient served as his or her own control, using a `split-face' design. Following skin cleansing with an acetone solution, and approximately 60 minutes of drug and/or vehicle incubation, light treatment with a fixed dose was given using one of the three light sources. Up to 3 treatments were given, 3 weeks apart. Interim results were assessed at Weeks 9 and 12. The protocol includes additional follow-up visits scheduled for Weeks 26 and 52. The goal of the study was to guide selection of light source(s) for future development in the treatment of photodamaged skin, using the Company's proprietary Levulan PDT technology. The study was not designed to detect differences between the light sources. At Week 12, Levulan PDT with BLU-U light demonstrated material improvement in photodamaged skin, in comparison to BLU-U and vehicle. Statistical significance in net changes from baseline scores was achieved in 2 parameters of photodamage, namely mottled pigmentation (p=0.0348) and tactile roughness (p=0.0455). In addition, the trend toward improvement in a number of parameters was notably greater at Week 12 than Week 9, without any additional treatments with Levulan, which suggests that other parameters may also reach statistical significance over time. Specifically, Levulan with BLU-U showed greater improvements in mottled pigmentation, tactile roughness, fine wrinkling, sallowness and Global Photodamage Score (i.e. all the parameters that were measured except for telangiectasia (small blood vessels in the skin)), compared with areas treated with BLU-U and vehicle. BLU-U by itself is not known to have any effects on photodamaged skin. 10 These results support the conclusions of a prior independent study by Touma et al (2004), using Levulan with BLU-U versus BLU-U alone, that achieved statistical significance with the addition of Levulan in all photodamage parameters measured, other than deep wrinkles. In that study, the investigators treated more severely sun-damaged patients, each with a minimum of 4 actinic keratoses. They also used twice the dose of blue light compared to the current study (10 vs. 5 Joules/cm2), and drug incubation times ranging from 1-3 hours. IPL by itself has previously been shown in independent studies to significantly improve photodamage, predominantly by targeting brown discoloration and red blood vessels. Therefore, as would be expected, at Week 12, significant improvement in photodamage was seen with IPL and vehicle, especially with respect to mottled pigmentation and telangiectasia. With the addition of Levulan, there was a trend toward even greater improvement in all parameters of photodamage except for mottled pigmentation, although these trends did not achieve statistical significance. However, similar to the BLU-U results, the trend toward improvement was notably greater at Week 12 than Week 9 without any additional treatments with Levulan, and additional follow up is scheduled at weeks 26 and 52. These results support the conclusions of prior independent studies by Dover et al (2005), Alster et al (2005), and Gold et al (in press) using Levulan with IPL versus IPL alone for photodamage. All of these studies reported significant benefits from the addition of Levulan to IPL, especially in patients with significant photodamage. In addition, although IPL itself does not treat pre-cancerous cell damage, such as actinic keratoses, when combined with Levulan (ALA) to produce a PDT effect, IPL has been reported to effectively remove these lesions (Avram and Goldman, 2004, Ruiz-Rodrigues, 2002). With LPDL, as would be expected, there was significant improvement in photodamaged skin with LPDL and vehicle, especially with respect to telangiectasia, the primary target of this device. However, with LPDL, the addition of Levulan for the treatment of photodamage did not lead to any discernable differences in photodamage parameters between the two groups, as suggested by the results of an earlier study (Smith et al, 2004). In general, safety was excellent in all groups, but treatment using Levulan with BLU-U was better tolerated than treatment with IPL or LPDL (with or without Levulan) i.e. the frequency and severity of stinging and burning during treatment was greater with IPL and LPDL (with or without Levulan) compared to Levulan with BLU-U, and for BLU-U with vehicle. Levulan with BLU-U was also easy to use and less operator dependent. Acne. Acne is a common skin condition caused by the blockage and/or inflammation of sebaceous (oil) glands. Traditional treatments for mild to moderate facial inflammatory acne include over-the-counter topical medications for mild cases, and prescription topical medications or oral antibiotics for mild to moderate cases. For nodulo-cystic acne, an oral retinoid drug called Accutane(R)(2) is the most commonly prescribed treatment. It is also commonly used for moderate to severe inflammatory acne. Over-the-counter treatments are not effective for many patients and can result in side effects including drying, flaking and redness of the skin. Prescription antibiotics lead to improvement in many cases, but patients must often take them on a long-term basis, with the associated risks of increased antibiotic resistance. With Levulan(R) PDT therapy for moderate to severe acne vulgaris we are seeking to improve or clear patients' acne without the need for long-term oral therapy and with fewer side effects than current therapies. - ---------- (2) Accutane(R) is a registered trademark of Hoffmann-La Roche, Inc. 11 DUSA has clearance from the FDA to market the BLU-U(R) without Levulan(R) PDT for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions. During the fourth quarter of 2004, we initiated a DUSA-sponsored Phase II study which we recently completed. This 72 patient, investigator blinded study was designed to examine various safety and efficacy parameters as a function of varying Levulan/vehicle incubation times, namely 15, 60 and 120 minutes. Patients were randomized within each incubation group so that 18 subjects received `Levulan BLU-U' and six received `BLU-U alone'. There were no formal placebo arms in this study. Up to four PDT treatments were given at 2-week intervals. The primary efficacy parameters were the percent change in total acne lesion count for inflammatory, non-inflammatory, and total lesions at 4 and 8 weeks after the final PDT session. Acne severity scores (grades 0 - 4) were also assessed. Safety and tolerability were also followed throughout the study. The results of the study indicate that both `Levulan BLU-U' and `BLU-U alone' appear to effectively reduce the number of both inflammatory and non-inflammatory acne lesions. Given the higher than anticipated `BLU-U alone' response rate using this protocol, the study was not powered (sized) to discern differences between these arms. Using an intent-to-treat analysis, at the Week 8 time point, the median percent decrease in total lesion count, (inflammatory plus non-inflammatory) for `Levulan BLU-U' and `BLU-U alone' was 61% and 80%, respectively. In the overall `Acne Severity Assessment' at the Week 8 time point, the `Levulan BLU-U' group showed 7/18 (39%) of subjects had at least 2 grades of improvement in their acne, compared with 4/6 (67%) in the `BLU-U alone' group. In the group of 28 patients with the most severe (Grade 4) acne, which included those with the highest number of inflammatory lesions at baseline (> or = 60 lesions), the total lesion count at Week 8 decreased in the `Levulan BLU-U' group, whereas total lesion count at Week 8 increased in the `BLU-U alone' group. Treatment was well tolerated in both arms of the study with no unanticipated adverse events being reported. Side effects were minimal. In the 15-minute Levulan BLU-U group, no PDT treatments were discontinued due to pain, and at the Week 8 time-point, there were no significant differences between the groups in erythema, edema or hyperpigmentation. The results of this study suggest that for future development of the acne indication for Levulan PDT, those patients with the most severe form(s) of acne should receive the greatest benefit. During September 2005, the FDA issued draft guidance for the pharmaceutical industry regarding the development of new drugs for acne vulgaris treatment. As a result of this newly issued guidance in combination with the results of our own Phase II clinical study on inflammatory acne, additional Phase II work will definitely be required before we commence Phase III acne trials. OTHER POTENTIAL DERMATOLOGY INDICATIONS We believe that there are numerous other potential uses for Levulan(R) PDT/PD in dermatology, and we continue to support, research in several of these areas, with corporate-sponsored trials, pilot trials, and/or investigator-sponsored studies, based on pre-clinical, clinical, regulatory and marketing criteria we have established through our strategic planning processes. Some of the additional potential uses for Levulan(R) in dermatology include treatment of skin conditions such as psoriasis, onychomycosis, warts, molluscum contagiosum, oily skin, acne rosacea, cystic acne, inflamed or infected sweat glands (hidradenitis suppurativa), and cancers, such as squamous cell carcinomas and cutaneous T-cell lymphomas. Of these potential indications, we have supported investigator-sponsored studies for psoriasis, hidradenitis suppurativa, acne vulgaris, basal cell carcinoma, and acne rosacea and are currently supporting investigator-sponsored studies for psoriasis, non-melanoma skin cancer, and inflammatory acne. 12 INTERNAL INDICATIONS Barrett's Esophagus Dysplasia. Barrett's esophagus is an acquired condition in which the normal tissue lining of the esophagus is replaced by abnormal tissue in response to chronic exposure to stomach acid. Over time, the area of the esophagus affected can develop dysplastic (precancerous) cells. As the dysplasia progresses from low-grade to high-grade, the risk of esophageal cancer increases significantly, such that patients with confirmed high-grade dysplasia often undergo major surgery to remove the affected portion of the esophagus. The condition is often undetected until the disease reaches later stages. Medical treatment of the condition has commonly included lifelong anti-reflux therapy with drugs called proton pump inhibitors to reduce stomach acid, while treatment for more advanced, precancerous, Barrett's esophagus dysplasia involves surgery to remove affected areas of the esophagus. The role of anti-reflux surgery, and/or medical devices is also being evaluated by the medical community. In August 2003, a competitor received approval for its PDT therapy for Barrett's esophagus. See section entitled "Business - Competition". Independent European studies have reported that in late-stage Barrett's esophagus the high-grade dysplasia can be destroyed by ALA PDT. In a randomized, controlled European investigator study supported by DUSA, the investigators reported that Levulan(R) PDT allowed the conversion of early-stage Barrett's esophagus with low-grade dysplasia and portions of non-dysplastic Barrett's back to a normal esophageal lining. During the second half of 2001, we started two Phase I/II studies for the treatment of early and late-stage Barrett's esophagus, respectively, using systemic Levulan(R) followed by red laser light in varying light doses. Patients were randomized to receive various light doses, with retreatment if required, and follow-up for 24 months after the initial treatment. In our clinical trial in which the primary efficacy goal was the ablation of high-grade dysplasia, or HGD, in Barrett's esophagus (late stage Barrett's esophagus), six patients with HGD were treated with Levulan(R) PDT. Of the six patients treated, 5 had complete clearing of their areas of high-grade dysplasia, and 4 of those patients have now been followed for 24 months and remain free of HGD, which indicates a durable response for complete HGD ablation. One patient dropped from follow-up at the 2-month visit. No esophageal scarring or ruptures were noted in the course of this study. HGD ablation continues in the patients followed. In our low-grade dysplasia (early stage) clinical trial in which the primary efficacy goal was the conversion of Barrett's esophagus to normal esophagus, 11 patients were treated with Levulan(R) PDT, and 4 were followed for 12 months while six were followed for 24 months (n=6). Complete Barrett's esophagus mucosal ablation after one or two Levulan(R) PDT treatment remained stable in 5/10 (50%) of patients for up to 2 years. Of those patients followed for 2 years, 4/6 (67%) remained clear for that time. There was 1 patient in this study that had mild circumferential esophageal scarring without symptoms. The most common adverse events in both studies were mild to moderate nausea and vomiting. In order to control ongoing research and development costs, we chose not to enroll any additional patients to these studies after 2002, but continued to follow the patients that have already been treated. Currently, for the treatment of HGD in BE, insertion of a fiber optic is done by placement of a balloon catheter system, which requires approximately three insertions into the patient's esophagus, with `blind' light treatment by the physician (the endoscope is removed before light treatment and then replaced afterwards). DUSA's proprietary endoscopic light delivery allows fiber optic placement and light treatment to the esophagus to be performed under direct visualization, utilizing a single insertion. The goal of this device is to allow the endoscopic light treatment to be performed more rapidly, under direct visualization, and with greater comfort for the patient. In preparation for a larger Phase II clinical trial, in the second quarter of 2004 we initiated a small single-center pilot Phase II clinical trial for enrollment of up to six patients at a single site using DUSA's proprietary endoscopic light delivery device 13 for the treatment of HGD. The protocol was amended to lower the light dosage and to allow in-hospital observation for the remaining 3 patients commencing in March 2005. As of the end of 2005, six patients received at least one Levulan(R) PDT treatment in this single-center study, and 5 are evaluable for acute efficacy. Four out of five (4/5, 80%) are currently free of HGD after treatment and continue to be followed. In addition, we are working with the National Cancer Institute Division of Cancer Prevention (NCI DCP), for the clinical development of Levulan(R) PDT for the treatment of high-grade dysplasia within Barrett's Esophagus. The Phase I/II trial design is being finalized and the NCI DCP has identified two clinical sites from its extramural expert clinical investigator consortium. The NCI DCP will use its resources to file its own Investigational New Drug, or IND, application. DUSA will provide Levulan(R), device(s) and the necessary training for the investigators involved in the studies. DUSA will maintain full ownership of its existing intellectual property, has options on new intellectual property, and, subject to successful Phase II and III clinical trial results, intends to seek FDA approval in due course. DUSA anticipates that the NCI DCP will begin the clinical trial during 2006. Oral Cavity Dysplasia. We have also signed a clinical trial agreement with the NCI DCP for the clinical development of Levulan(R) PDT for the treatment of oral cavity dysplasia. During 2005, DUSA and the NCI DCP collaborated to develop the protocol for a Phase I study in subjects with oral leukoplakia (a premalignant lesion) using NCI's Phase I/II Cancer Prevention Clinical Trials Consortia to perform the studies. As of the end of 2005, the NCI DCP had selected consortia for consideration as clinical trial sites. DUSA also expects this study to begin during 2006. Brain Cancer. Despite standard therapies that include surgical tumor removal, radiation therapy, and chemotherapy, adult patients with the most aggressive high-grade malignant brain tumor type, glioblastoma multiforme, generally survive only 1 year. Independent European investigators have reported that systemic ALA dosing before surgical resection of tumors resulted in selective fluorescence of only the tumors. The normal white matter of the brain showed no fluorescence. These investigators used ALA-induced fluorescence in a study involving 52 patients with glioblastoma multiforme as a guide for the more complete removal of tumors than would be possible using white light alone. This technique is called fluorescence-guided resection. In December 2002, we entered into a License and Development Agreement with photonamic GmbH & Co. KG, a subsidiary of medac GmbH, a German pharmaceutical company. This agreement provides for the licensing to us of photonamic's proprietary technology related to ALA for systemic dosing in the field of brain cancer. The technology provides DUSA with access to a systemic formulation of ALA, and a significant amount of pre-clinical data, both of which could be useful and are licensed to DUSA for certain other indications, including Barrett's esophagus dysplasia. photonamic completed its European Phase III clinical trial in which ALA-induced fluorescence was used to guide surgical tumor resection in patients suffering from glioblastoma multiforme. DUSA believes that the European Phase III clinical trial results, although they might meet the primary efficacy parameters of the protocol as written, might require the support of additional clinical trials which would take years to complete in order to meet the regulatory requirements for approval in the United States. We do not intend, at this time, to repeat this study or to carry out additional studies in this indication in the United States. However, we have agreed to accompany photonamics to the FDA should it wish to request a Pre-IND meeting with the FDA for this indication. See section entitled "Business - Licenses". THIRD-PARTY REIMBURSEMENT We have continued to support efforts to improve reimbursement levels to physicians. Such efforts included working with the Centers for Medicare and Medicaid Services, or CMS, and the American 14 Academy of Dermatology Association, or AADA, on matters related to the PDT procedure fee and the separate drug reimbursement fee. Doctors can also bill for any applicable visit fees. Effective January 1, 2006, the CMS average national reimbursement for the use of Levulan(R) PDT for AKs' Ambulatory Patient Classifications code ("APC code") was increased. The APC code is used by many hospitals. The CMS Current Procedural Terminology code ("CPT code"), which is used by private physician clinics using Levulan(R) PDT for treating AKs was not increased for 2006 (i.e. it will be unchanged from 2005 levels). DUSA had expected reimbursement under the CPT code to increase on January 1, 2006; however, we now believe that the increase will not be effective until January 1, 2007 based on information from CMS and the AADA. We are aware that some physicians believe that reimbursement levels do not fully reflect the required efforts to routinely execute our therapy in their practices. We believe that the issues related to reimbursement have negatively impacted the economic competitiveness of our therapy with other AK therapies and have hindered its adoption in the past. DUSA continues to support ongoing efforts that might lead to further increases in reimbursement in the future; and intends to continue supporting efforts to seek reimbursement for our FDA-cleared use of the BLU-U(R) alone in the treatment of mild to moderate inflammatory acne of the face. Most major private insurers have approved coverage for our AK therapy. We believe that due to these efforts, plus future improvements, along with our education and marketing programs, a more widespread adoption of our therapy should occur over time. SUPPLY PARTNERS National Biological Corporation. In November 1998, we entered into a purchase and supply agreement with National Biological Corporation, or NBC, for the manufacture of some of our light sources, including the BLU-U(R). We agreed to order from NBC all of our supply needs of these light sources for the United States and Canada, and NBC agreed to supply us with the quantities we order. If an opportunity arises, the parties have agreed to negotiate the terms under which NBC would supply us with light sources for sale in countries other than the current territories. On June 21, 2004, DUSA signed an Amended and Restated Purchase and Supply Agreement with NBC, which provides for the elimination of certain exclusivity clauses, permits DUSA to order on a purchase order basis without minimums, grants DUSA an exclusive irrevocable worldwide and fully-paid up license to manufacture, or have the BLU-U(R) manufactured by any third party subcontractor, and other modifications which provide both parties greater flexibility related to the development and manufacture of light sources, and the associated technology within the field of PDT. The agreement maintains the original term, which will expire in November 2008, subject to earlier termination for breach or insolvency or for convenience. However, a termination for convenience requires 12 months' prior written notice. Sochinaz SA. Under an agreement dated December 24, 1993, Sochinaz SA manufactures and supplies our requirements of Levulan(R) from its FDA approved facility in Switzerland. The agreement expires on December 31, 2009. While we can obtain alternative supply sources in certain circumstances, any new supplier would have to be inspected and qualified by the FDA. medac GmbH. In December 2002, we entered into a supply agreement with medac GmbH in connection with the photonamic license agreement mentioned above. We have a license to market and sell the formulation exclusively in the United States and in several other countries and non-exclusively in the rest of the world subject to certain field limitations. The supply agreement covers medac's current systemic dosage formulation for use in brain cancer, Barrett's esophagus, as well as for other mutually agreed upon indications. The agreement provides for minimum purchase requirements following our first commercial sale and has a term of 10 years from the date of our first commercial sale, subject to earlier termination rights, as well as successive one-year renewal terms. 15 LICENSES PARTEQ Research and Development Innovations. We license (or, in the case of the patents in Australia, were assigned) the patents underlying our Levulan(R) PDT/PD systems under a license agreement with PARTEQ Research and Development Innovations, or PARTEQ, the licensing arm of Queen's University, Kingston, Ontario. Under the agreement, which became effective August 27, 1991, we have been granted an exclusive worldwide license, with a right to sublicense, under PARTEQ's patent rights, to make, have made, use and sell products which are precursors of PpIX, including ALA. The agreement also covers any improvements discovered, developed or acquired by or for PARTEQ, or Queen's University, to which PARTEQ has the right to grant a license. A non-exclusive right is reserved to Queen's University to use the subject matter of the agreement for non-commercial educational and research purposes. A right is reserved to the Department of National Defense Canada to use the licensed rights for defense purposes including defense procurement but excluding sales to third-parties. When we are selling our products directly, we have agreed to pay to PARTEQ royalties of 6% and 4% on 66% of the net selling price in countries where patent rights do and do not exist, respectively. In cases where we have a sublicensee, we will pay 6% and 4% when patent rights do and do not exist, respectively, on our net selling price less the cost of goods for products sold to the sublicensee, and 6% of royalty payments we receive on sales of products by the sublicensee. We are also obligated to pay 5% of any lump sum sublicense fees paid to us, such as milestone payments, excluding amounts designated by the sublicensee for future research and development efforts. The agreement is effective for the life of the latest United States patents and becomes perpetual and royalty-free when no United States patent subsists. Annual minimum royalties to PARTEQ must total at least CDN $100,000 (U.S. $85,793 as of December 31, 2005) in order to retain the license. For 2005, royalties exceeded this minimum. We have the right to terminate the PARTEQ agreement with or without cause upon 90 days notice. See "Note 13(a) to the Company's Notes to the Consolidated Financial Statements". Together with PARTEQ and Draxis Health, Inc., our former parent, we entered into an agreement, known as the ALA Assignment Agreement, effective October 7, 1991. According to the terms of this agreement we assigned to Draxis our rights and obligations under the PARTEQ license agreement to the extent they relate to Canada. On February 24, 2004, we reacquired these rights and agreed to pay an upfront fee and a 10% royalty on sales of the Levulan(R) Kerastick(R) in Canada over a five-year term following the first commercial sale in Canada. We are now responsible for any royalties which would be due to PARTEQ for Canadian sales. Draxis also agreed to assign to us the Canadian regulatory approvals for the Levulan(R) Kerastick(R) with PDT for AKs. We also hold Canadian regulatory approval for the BLU-U(R). During 2004, we appointed a Canadian distributor who launched our Levulan(R) Kerastick(R) and BLU-U(R) in Canada. See sections entitled "Distribution" and "Note 13(b) to the Company's Notes to the Consolidated Financial Statements". photonamic GmbH & Co. KG. In December 2002, we entered into a license and development agreement with photonamic GmbH & Co. KG, a subsidiary of medac GmbH, a German pharmaceutical company. This agreement provides for the licensing to us of photonamic's proprietary technology related to aminolevulinic acid (ALA), the compound we use in our Levulan(R) PDT and photodetection (PD). Under the terms of the agreement, we received a license for the United States and several other countries, to use photonamic's technology, including pre-clinical and clinical data, related to ALA for systemic dosing in the field of brain cancer, and for indications which the parties may jointly develop during the term of their collaboration. Additionally, we are entitled to use the pre-clinical data for indications which we may develop on our own. See section entitled "Our Products". We paid a $500,000 up-front license fee, and will be obligated to pay certain regulatory milestones of $1,250,000 upon FDA acceptance of a registration application for a brain cancer product in the United States, an additional 16 $1,250,000 upon registration of the product, and royalties of 12.5% on net sales under the terms of the license and development agreement and royalties on net sales of any brain cancer product which utilizes the photonamic technology. Although we do not believe that the results from medac's European Phase III clinical study will be acceptable to the FDA, we have agreed to ask FDA for a pre-IND meeting if medac determines that it wishes to proceed. Should photonamic's clinical study be acceptable to the FDA, we will be obligated to proceed with development of the product in the United States in order to retain the license for the use of the technology in the treatment of brain cancer. The agreement has a term of 10 years from the date of first approval of a product using photonamic's technology, subject to earlier termination rights, as well as one-year renewal terms. We have also entered into a clinical trial agreement with photonamic to fund an independent investigator study using oral Levulan(R) for the treatment of psoriasis. A protocol for this study was established in 2005. Stiefel Laboratories, Inc. On January 12, 2006, we entered into an exclusive marketing, distribution and supply agreement with Stiefel Laboratories, Inc. The agreement covers current and future uses of our Levulan(R) Kerastick(R) PDT in dermatology. The agreement, which has an initial term of ten years, grants Stiefel the right to market and distribute our product in Mexico, Central and South America. We have completed the portion of the Brazilian regulatory submission for the use of Levulan PDT for actinic keratoses. Stiefel will complete final integration and submission of the data to the Brazilian regulatory agency with market launch expected in late 2006 or early 2007. Stiefel will prepare and file the regulatory applications in other countries in the territory subject to the terms of the Agreement, perhaps first launching in a country other than Brazil. All regulatory filings and registrations for approval will be owned by DUSA, unless otherwise agreed by DUSA. Stiefel will make up to $3,000,000 in milestone payments, based upon receipt of final pricing approval of the product from Brazilian regulatory authorities and achievement of certain minimum purchase levels in the territory, subject to certain terms and conditions. We will manufacture the Kerastick(R) for Stiefel in our manufacturing facility in Wilmington, Massachusetts. Stiefel will pay to DUSA a percentage of Stiefel's final selling price to third-parties subject to a certain minimum purchase price per unit and to other terms and conditions. Steifel has certain minimum purchase obligations. The parties have certain rights to terminate the Agreement prior to the end of the initial term, and Stiefel has an option to extend the term for an additional ten years on mutually agreeable terms and conditions. PATENTS AND TRADEMARKS We actively seek, when appropriate, to protect our products and proprietary information through United States and foreign patents, trademarks and contractual arrangements. In addition, we rely on trade secrets and contractual arrangements to protect certain aspects of our proprietary information and products. Our ability to compete successfully depends, in part, on our ability to defend our patents that have issued, obtain new patents, protect trade secrets and operate without infringing the proprietary rights of others. We have no product patent protection for the compound ALA itself, as our basic patents are for methods of detecting and treating various diseased tissues using ALA or related compounds called precursors, in combination with light. Even where we have patent protection, there is no guarantee that we will be able to enforce our patents. Patent litigation is expensive, and we may not be able to afford the costs. We own or exclusively license patents and patent applications related to the following: o methods of using ALA and its unique physical forms in combination with light, o compositions and apparatus for those methods, and o unique physical forms of ALA. 17 These patents expire no earlier than 2009, and certain patents are entitled to terms beyond that date. Effective September 29, 2003, the United States Patent and Trademark Office extended the term of U.S Patent No. 5,079,262, with respect to our approved AK indication for Levulan(R), until September 29, 2013. Under the license agreement with PARTEQ, we hold an exclusive worldwide license to certain patent rights in the United States and a limited number of foreign countries. See section entitled "Business - Licenses". All United States patents and patent applications licensed from PARTEQ relating to ALA are method of treatment patents. Method of treatment patents limit direct infringement to users of the methods of treatment covered by the patents. We currently have patents and/or pending patent applications in the United States and in a number of foreign countries covering unique physical forms of ALA, compositions containing ALA, as well as ALA applicators, light sources for use with ALA, and other technology. We cannot guarantee that any pending patent applications will mature into issued patents. We have limited patent protection outside the United States, which may make it easier for third-parties to compete there. Our basic method of treatment patents and applications have counterparts in only six foreign countries and under the European Patent Convention. See sections entitled "Risk Factors - Risks Related to DUSA" and "Legal Proceedings". We can provide no assurance that a third-party or parties will not claim, with or without merit, that we have infringed or misappropriated their proprietary rights. A number of entities have obtained, and are attempting to obtain patent protection for various uses of ALA. We can provide no assurance as to whether any issued patents, or patents that may later issue to third-parties, may affect the uses on which we are working or whether such patents can be avoided, invalidated or licensed if they cannot be avoided or invalidated. If any third-party were to assert a claim for infringement, as one party has already done, we can provide no assurance that we would be successful in the litigation or that such litigation would not have a material adverse effect on our business, financial condition and results of operation. Furthermore, we may not be able to afford the expense of defending against any such additional claim. In addition, we cannot guarantee that our patents, whether owned or licensed, or any future patents that may issue, will prevent other companies from developing similar or functionally equivalent products. Further, we cannot guarantee that we will continue to develop our own patentable technologies or that our products or methods will not infringe upon the patents of third-parties. In addition, we cannot guarantee that any of the patents that may be issued to us will effectively protect our technology or provide a competitive advantage for our products or will not be challenged, invalidated, or circumvented in the future. We also attempt to protect our proprietary information as trade secrets. Generally agreements with employees, licensing partners, consultants, universities, pharmaceutical companies and agents contain provisions designed to protect the confidentiality of our proprietary information. However, we can provide no assurance that these agreements will provide effective protection for our proprietary information in the event of unauthorized use or disclosure of such information. Furthermore, we can provide no assurance that our competitors will not independently develop substantially equivalent proprietary information or otherwise gain access to our proprietary information, or that we can meaningfully protect our rights in unpatentable proprietary information. Even in the absence of composition of matter patent protection for ALA, we may receive financial benefits from: (i) patents relating to the use of such products (like PARTEQ's patents); (ii) patents relating to special compositions and formulations; (iii) limited marketing exclusivity that may be available under the Hatch-Waxman Act and any counterpart protection available in foreign countries and (iv) patent term extension under the Hatch-Waxman Act. See section entitled "Business - Government 18 Regulation". Effective patent protection also depends on many other factors such as the nature of the market and the position of the product in it, the growth of the market, the complexities and economics of the process for manufacture of the active ingredient of the product and the requirements of the new drug provisions of the Food, Drug and Cosmetic Act, or similar laws and regulations in other countries. We seek registration of trademarks in the United States, and other countries where we may market our products. To date, we have been issued 27 trademark registrations, and other applications are pending. MANUFACTURING On July 14, 2003, we received approval from the FDA to manufacture the Levulan(R) Kerastick(R) at our Wilmington, Massachusetts manufacturing facility. In February 2004, we began commercial production of our Levulan(R) Kerastick(R) after having terminated the former third-party contract manufacturing arrangement. We plan to maintain a reasonable level of Kerastick(R) inventory based on sales projections. During the third quarter of 2005, we received FDA approval to manufacture our BLU-U(R) brand light source in our Wilmington, Massachusetts facility. However, at this time, we expect to utilize our own facility only as a back-up to our current third-party manufacturer or for repairs. Our drug, Levulan(R), and the BLU-U(R) brand light source are each manufactured by single third-party suppliers. DISTRIBUTION We have been a direct distributor of the BLU-U(R) since its launch. Effective January 1, 2006, we have increased our own distribution capacity and have become the sole distributor for our Levulan(R) Kerastick(R) in the United States. In March 2004, we signed an exclusive Canadian marketing and distribution agreement for the Levulan(R) Kerastick(R) and BLU-U(R) with Coherent-AMT Inc., or Coherent, a leading Canadian medical device and laser distribution company. Coherent began marketing the BLU-U(R) in April 2004 and the Kerastick(R) in June 2004, following receipt of the applicable regulatory approval from Health Canada. The agreement has a three-year term, which can be automatically renewed for additional one-year terms, unless either party notifies the other party prior to a term expiration that it does not intend to renew the agreement. Coherent has the right for a period of time following termination of its agreement to return inventory of product. In January 2006, we entered into a marketing and distribution agreement for the Levulan(R) Kerastick(R) with Stiefel Laboratories, Inc. Under the agreement, Stiefel was granted an exclusive right to distribute Levulan(R) Kerastick(R) in Mexico, Central and South America. The Agreement has an initial term of ten years. DUSA has completed its portion of the Brazilian regulatory submission for the use of Levulan PDT for actinic keratoses. Effective with the signing of the Agreement, Stiefel will complete final integration and submission of the data to the Brazilian regulatory agency with market launch expected in late 2006 or early 2007. Stiefel may launch the product in Mexico or other countries in the territory prior to a launch in Brazil. See section entitled "Business - Licenses, Stiefel Laboratories, Inc." MARKETING AND SALES DUSA markets its approved dermatology products in the United States. We have appointed Coherent-AMT as marketing partner for our products in Canada and Stiefel for our Levulan(R) Kerastick(R) in Mexico, Central and South America. As a result of reacquiring our product rights in late 2002 from a former marketing partner, we commenced marketing and sales activities for our products in 2003, including the launch of our sales force in October 2003. Initially the sales force was comprised of six direct representatives, various 19 independent representatives, and an independent sales distributor, designed to focus on most of our key geographic markets in the United States. During 2005, we continued our efforts to penetrate the market by expanding our sales coverage in key geographic locations. As of December 31, 2005, we have further increased the size of our sales force to 24 sales representatives deployed nationally. Following the receipt of marketing approval from the Health Protection Branch - Canada in June 2004, we started to market and sell the Levulan(R) Kerastick(R) with PDT using the BLU-U(R) for AKs of the face or scalp in Canada through Coherent-AMT. We anticipate that Stiefel will complete final integration and submission of the data to the Brazilian regulatory agency with market launch expected in late 2006 or early 2007 and perhaps sooner in other countries in its territory. See sections entitled "Business - Licenses and Distribution". COMPETITION Commercial development of PDT agents other than Levulan(R) is currently being pursued by a number of companies. These include: QLT Inc. (Canada); Axcan Pharma Inc. (United States); Miravant, Inc. (United States); Pharmacyclics, Inc. (United States); PhotoTherapeutics, Inc. (U.K.); medac GmbH and photonamic GmbH & Co. KG (Germany); and PhotoCure ASA (Norway) who entered into a marketing agreement with Galderma S.A. for countries outside of Nordic countries for certain dermatology indications. Several of these companies are also commercializing and/or conducting research with ALA or ALA-related compounds. PhotoCure has received marketing approval of its ALA precursor (ALA methyl-ester) compound for PDT treatment of AK and basal cell carcinoma, called BCC, in the European Union, New Zealand, Australia, and countries in Scandinavia. In July 2004, PhotoCure received FDA approval in the United States for its AK therapy. However, in December 2004 the FDA notified PhotoCure that its new drug application, or NDA, for BCC was not approvable. If PhotoCure enters into the marketplace with its AK therapy, its product will directly compete with our products. In April 2002, we received a copy of a notice issued by PhotoCure ASA to Queen's University at Kingston, Ontario, alleging that one of the patents covered by our agreement with PARTEQ, Australian Patent No. 624985, relating to ALA, was invalid. As a consequence of this action, Queen's University assigned the Australian patent to us so that we could participate directly in this litigation. In April 2005, the Federal Court of Australia ruled that the Australian patent assigned to DUSA by Queen's University which relates to DUSA's aminolevulinic acid photodynamic therapy is valid and remains in full force and effect. However, the Court also ruled that PhotoCure's product, Metvix, does not infringe the claims in the Australian patent. We have been negotiating a settlement with PhotoCure pertaining to certain of our patents and we expect the agreement to be finalized in the first half of 2006. See section entitled "Legal Proceedings". In August 2003, Axcan Pharma Inc. received FDA approval for the use of its product, PHOTOFRIN(R)(3), for photodynamic therapy in the treatment of high grade dysplasia associated with Barrett's esophagus. This approval enabled Axcan to be the first company to market a PDT therapy for this indication which we are also pursuing. There are also non-PDT products for the treatment of AKs, including cryotherapy with liquid nitrogen, 5-fluorouracil (Efudex(R))(4), diclofenac sodium (Solaraze(R))(5), and imiquimod (ALDARA(TM))(6). Other - ---------- (3) PHOTOFRIN(R) is a registered trademark of Axcan Pharma Inc. (4) Efudex(R) is a registered trademark of Valeant Pharmaceuticals International. (5) Solaraze(R) is a registered trademark of SkyePharma PLC. (6) ALDARA(TM) is a trademark of 3M Company. 20 AK therapies are also known to be under development, by companies such as Medigene (GmbH), Peplin (Australia) and others. The pharmaceutical industry is highly competitive, and many of our competitors have substantially greater financial, technical and marketing resources than we have. In addition, several of these companies have significantly greater experience than we do in developing products, conducting preclinical and clinical testing and obtaining regulatory approvals to market products for health care. Our competitors may succeed in developing products that are safer or more effective than ours and in obtaining regulatory marketing approval of future products before we do. Our competitiveness may also be affected by our ability to manufacture and market our products and by the level of reimbursement for the cost of our drug and treatment by third-party payors, such as insurance companies, health maintenance organizations and government agencies. We believe that comparisons of the properties of various photosensitizing PDT drugs will also highlight important competitive issues. We expect that our principal methods of competition with other PDT companies will be based upon such factors as the ease of administration of our photodynamic therapy; the degree of generalized skin sensitivity to light; the number of required doses; the selectivity of our drug for the target lesion or tissue of interest; and the type and cost of our light systems. New drugs or future developments in PDT, laser products or in other drug technologies may provide therapeutic or cost advantages for competitive products. No assurance can be given that developments by other parties will not render our products uncompetitive or obsolete. DUSA also markets the BLU-U(R) without Levulan(R) for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions. Our competition for the BLU-U(R) without Levulan(R) for moderate inflammatory acne vulgaris is primarily oral antibiotics, topical antibiotics and other topical prescription drugs, as well as various laser and non-laser light sources. As blue light alone for acne is still a relatively new therapy compared to existing therapies, reimbursement has not been established by private insurance companies, which may also affect our competitive position versus traditional therapies which are reimbursed. Our principal method of competition with existing therapies of AKs and moderate inflammatory acne vulgaris is patient benefits, including rapid healing and excellent cosmetic results. See section entitled "Business - Dermatology Indications, Actinic Keratoses; Acne". GOVERNMENT REGULATION The manufacture and sale of pharmaceuticals and medical devices in the United States are governed by a variety of statutes and regulations. These laws require, among other things: o approval of manufacturing facilities, including adherence to current good manufacturing practices, laboratory and clinical practices during production and storage known as cGMP, QSR, GLP and GCP, o controlled research and testing of products, o applications for marketing approval containing manufacturing, preclinical and clinical data to establish the safety and efficacy of the product, and o control of marketing activities, including advertising and labeling. The marketing of pharmaceutical products requires the approval of the FDA in the United States, and similar agencies in other countries. The FDA has established regulations and safety standards, which apply to the preclinical evaluation, clinical testing, manufacture and marketing of pharmaceutical products. The process of obtaining marketing approval for a new drug normally takes several years and often involves significant costs. The steps required before a new drug can be produced and marketed for human use in the United States include: 21 o preclinical studies o the filing of an Investigational New Drug, or IND, application, o human clinical trials, and o the approval of a New Drug Application, or NDA. Preclinical studies are conducted in the laboratory and on animals to obtain preliminary information on a drug's efficacy and safety. The time required for conducting preclinical studies varies greatly depending on the nature of the drug, and the nature and outcome of the studies. Such studies can take many years to complete. The results of these studies are submitted to the FDA as part of the IND application. Human testing can begin if the FDA does not object to the IND application. The human clinical testing program involves three phases. Each clinical study is typically conducted under the auspices of an Institutional Review Board, or IRB, at the institution where the study will be conducted. An IRB will consider among other things, ethical factors, the safety of human subjects, and the possible liability of the institution. A clinical plan, or "protocol," must be submitted to the FDA prior to commencement of each clinical trial. All patients involved in the clinical trial must provide informed consent prior to their participation. The FDA may order the temporary or permanent discontinuance of a clinical trial at any time for a variety of reasons, particularly if safety concerns exist. These clinical studies must be conducted in conformance with the FDA's bioresearch monitoring regulations. In Phase I, studies are usually conducted on a small number of healthy human volunteers to determine the maximum tolerated dose and any product-related side effects of a product. Phase I studies generally require several months to complete, but can take longer, depending on the drug and the nature of the study. Phase II studies are conducted on a small number of patients having a specific disease to determine the most effective doses and schedules of administration. Phase II studies generally require from several months to 2 years to complete, but can take longer, depending on the drug and the nature of the study. Phase III involves wide scale studies on patients with the same disease in order to provide comparisons with currently available therapies. Phase III studies generally require from six months to four years to complete, but can take longer, depending on the drug and the nature of the study. Data from Phase I, II and III trials are submitted to the FDA with the NDA. The NDA involves considerable data collection, verification and analysis, as well as the preparation of summaries of the manufacturing and testing processes and preclinical and clinical trials. Submission of an NDA does not assure FDA approval for marketing. The application review process generally takes 1 to 4 years to complete, although reviews of treatments for AIDS, cancer and other life-threatening diseases may be accelerated, expedited or subject to fast track treatment. The process may take substantially longer if, among other things, the FDA has questions or concerns about the safety and/or efficacy of a product. In general, the FDA requires properly conducted, adequate and well-controlled clinical studies demonstrating safety and efficacy with sufficient levels of statistical assurance. However, additional information may be required. For example, the FDA may also request long-term toxicity studies or other studies relating to product safety or efficacy. Even with the submission of such data, the FDA may decide that the application does not satisfy its regulatory criteria for approval and may disapprove the NDA. Finally, the FDA may require additional clinical tests following NDA approval to confirm safety and efficacy, often referred to as Phase IV clinical trials. Upon approval, a prescription drug may only be marketed for the approved indications in the approved dosage forms and at the approved dosage with the approved labeling. Adverse experiences with the product must be reported to the FDA. In addition, the FDA may impose restrictions on the use of the drug that may be difficult and expensive to administer. Product approvals may be withdrawn if 22 compliance with regulatory requirements is not maintained or if problems occur or are discovered after the product reaches the market. After a product is approved for a given indication, subsequent new indications, dosage forms, or dosage levels for the same product must be reviewed by the FDA after the filing and upon approval of a supplemental NDA. The supplement deals primarily with safety and effectiveness data related to the new indication or dosage. Finally, the FDA requires reporting of certain safety and other information, often referred to as "adverse events" that become known to a manufacturer of an approved drug. Safety information collected through this process can result in changes to a product's labeling or withdrawal of a product from the market. If an active ingredient of a drug product has been previously approved, drug applications can be filed that may be less time-consuming and costly. On December 3, 1999, the FDA approved the marketing of our Levulan(R) Kerastick(R) 20% Topical Solution with PDT for treatment of AKs of the face or scalp. The commercial version of our BLU-U(R), used together with the Kerastick(R) to provide PDT for the treatment of non-hyperkeratotic actinic keratoses, or AKs, of the face or scalp, was approved on September 26, 2000. In September 2003, we received clearance from the FDA to market the BLU-U(R) without Levulan(R) PDT for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions. Other than the FDA-approved use of the Levulan(R) Kerastick(R) with PDT for treatment of AKs, and the FDA clearance to market the BLU-U for moderate inflammatory acne and other dermatologic conditions, our other potential products still require significant development, including additional preclinical and/or clinical testing, and regulatory marketing approval prior to commercialization. The process of obtaining required approvals can be costly and time consuming and there can be no guarantee that the use of Levulan(R) in any future products will be successfully developed, prove to be safe and effective in clinical trials, or receive applicable regulatory marketing approvals. Medical devices, such as our light source device, are also subject to the FDA's rules and regulations. These products are required to be tested, developed, manufactured and distributed in accordance with FDA regulations, including good manufacturing, laboratory and clinical practices. Under the Food, Drug & Cosmetic Act, all medical devices are classified as Class I, II or III devices. The classification of a device affects the degree and extent of the FDA's regulatory requirements, with Class III devices subject to the most stringent requirements and FDA review. Generally, Class I devices are subject to general controls (for example, labeling and adherence to the cGMP requirement for medical devices), and Class II devices are subject to general controls and special controls (for example, performance standards, postmarket surveillance, patient registries and FDA guidelines). Class III devices, which typically are life-sustaining or life-supporting and implantable devices, or new devices that have been found not to be substantially equivalent to a legally marketed Class I or Class II "predicate device," are subject to general controls and also require clinical testing to assure safety and effectiveness before FDA approval is obtained. The FDA also has the authority to require clinical testing of Class I and II devices. The BLU-U(R) is part of a combination product as defined by FDA and therefore has been classified as a Class III device. We are developing an endoscopic device for the Barrett's esophagus indication which we believe will also be classified as Class III and be subject to the highest level of FDA regulation. Approval of Class III devices require the filing of a premarket approval, or PMA, application supported by extensive data, including preclinical and clinical trial data, to demonstrate the safety and effectiveness of the device. If human clinical trials of a device are required and the device presents a "significant risk," the manufacturer of the device must file an investigational device exemption or "IDE" application and receive FDA approval prior to commencing human clinical trials. At present, our devices are being studied in preclinical and clinical trials under our INDs. Following receipt of the PMA application, if the FDA determines that the application is sufficiently complete to permit a substantive review, the agency will accept it for filing and further review. Once the submission is filed, the FDA begins a review of the PMA application. Under the 23 Medical Device User Fee and Modernization Act, the FDA has 180 days to review a PMA application and respond to the sponsor. The review of PMA applications more often occurs over a significantly protracted time period, and the FDA may take up to 2 years or more from the date of filing to complete its review. In addition, a PMA for a device which forms part of a combination product will not be approved unless and until the NDA for the corresponding drug is also approved. The PMA process can be expensive, uncertain and lengthy. A number of other companies have sought premarket approval for devices that have never been approved for marketing. The review time is often significantly extended by the FDA, which may require more information or clarification of information already provided in the submission. During the review period, an advisory committee likely will be convened to review and evaluate the PMA application and provide recommendations to the FDA as to whether the device should be approved for marketing. In addition, the FDA will inspect the manufacturing facility to ensure compliance with cGMP requirements for medical devices prior to approval of the PMA application. If granted, the premarket approval may include significant limitations on the indicated uses for which the product may be marketed, and the agency may require post-marketing studies of the device. Medical products containing a combination of drugs, including biologic drugs, or devices may be regulated as "combination products". A combination product generally is defined as a product comprised of components from 2 or more regulatory categories (drug/device, device/biologic, drug/biologic, etc.). In December 2002, the FDA established the Office of Combination Products, or OCP, whose responsibilities, according to the FDA, will cover the entire regulatory life cycle of combination products, including jurisdiction decisions as well as the timeliness and effectiveness of pre-market review, and the consistency and appropriateness of post-market regulation. In connection with our NDA for the Levulan(R) Kerastick(R) with PDT for AKs, a combination filing (including a PMA for the BLU-U(R) light source device and the NDA for the Levulan(R) Kerastick(R)) was submitted to the Center for Drug Evaluation and Research. The PMA was then separated from the NDA submission by the FDA and reviewed by the FDA's Center for Devices and Radiological Health. Based upon this experience, we anticipate that any future NDAs for Levulan(R) PDT/PD will be a combination filing accompanied by PMAs. There is no guarantee that PDT products will continue to be regulated as combination products. The United States Drug Price Competition and Patent Term Restoration Act of 1984 known as the Hatch-Waxman Act establishes a 5-year period of marketing exclusivity from the date of NDA approval for new chemical entities approved after September 24, 1984. Levulan(R) is a new chemical entity and market exclusivity under this law expired on December 3, 2004. During this Hatch-Waxman marketing exclusivity period, the FDA will not approve another application submitted by a third-party for approval of a drug product which has the same reference listed drug as Levulan(R), i.e., ALA as its active ingredient. After the expiration of the Hatch-Waxman exclusivity period, any third-party who submits an application for approval for a drug product containing ALA must provide a certification that (i) no patent information has been filed; (ii) that such patent has expired; (iii) marketing will not commence until the patent(s) has expired; or (iv) that the patent is invalid or will not be infringed by the manufacture, use, or sale of the third-party applicant. Any abbreviated or paper NDA applicant will be subject to the notification provisions of the Hatch-Waxman Act, which should facilitate our notification about potential infringement of our patent rights. The abbreviated or paper NDA applicant must notify the NDA holder and the owner of any patent applicable to the abbreviated or paper NDA product, of the application and intent to market the drug that is the subject of the NDA. 24 In 2004, DUSA began marketing and selling our products in Canada. Generally, we try to design our protocols for clinical studies so that the results can be used in all the countries where we hope to market the product. However, countries sometimes require additional studies to be conducted on patients located in their country. Prior to marketing a product in other countries, approval by that nation's regulatory authorities must be obtained. Our former marketing partner had been responsible for applying for marketing approvals outside the United States for Levulan(R) PDT for dermatology uses and did file applications for approval in Austria, Australia, South Africa and Brazil. However, our focus has been primarily on the North American markets initially, and therefore we authorized our former partner to withdraw the applications for regulatory approval of Levulan(R) PDT in Australia, Austria and South Africa. In 2003, we also advised our former partner to withdraw the applications for the Levulan(R) Kerastick(R) and BLU-U(R) in Brazil, even though the Kerastick(R) had already been approved, as it was determined that such rights cannot be transferred to us. We, together with Stiefel under our recently completed agreement, are in the process of reapplying for approval in Brazil, but have not determined if we will reapply in any of the other countries at this time. With the enactment of the Drug Export Amendments Act of the United States in 1986, products not yet approved by the FDA may be exported to certain foreign markets if the product is approved by the importing nation and approved for export by the United States government. We can provide no assurance that we will be able to get approval for any of our potential products from any importing nations' regulatory authorities or be able to participate in the foreign pharmaceutical market. Our research and development activities have involved the controlled use of certain hazardous materials, such as mercury in fluorescent tubes. We are subject to various laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous materials and certain waste products. During the design, construction and validation phases of our Kerastick(R) facility, we have taken steps to ensure that appropriate environmental controls associated with the facility comply with environmental laws and standards. We can provide no assurance that we will not have to make significant additional expenditures in order to comply with environmental laws and regulations in the future. Furthermore, we cannot assure that current or future environmental laws or regulations will not materially adversely effect our operations, business or assets. Although we believe that our safety procedures for the handling and disposal of such hazardous materials comply with the standards prescribed by current environmental laws and regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, we could be held liable for any damages that result, and any such liability could exceed our resources. PRODUCT LIABILITY AND INSURANCE We are subject to the inherent business risk of product liability claims in the event that the use of our technology or any prospective product is alleged to have resulted in adverse effects during testing or following marketing approval of any such product for commercial sale. We maintain product liability insurance for coverage of our clinical trial activities and for our commercial supplies. There can be no assurance that such insurance will continue to be available on commercially reasonable terms or that it will provide adequate coverage against all potential claims. See section entitled "Legal Proceedings". EMPLOYEES At the end of 2005, we had 64 full-time employees and two part-time employees, which was an increase over the 2004 levels. We also retain numerous independent consultants and temporary employees to support our business needs. We have employment agreements with all of our key executive officers. 25 INTERNET INFORMATION Our internet site is located at www.dusapharma.com. Copies of our reports filed pursuant to Section 13(a) or 15(d) of the Exchange Act, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, may be accessed from our website, free of charge, as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to, the Securities and Exchange Commission. Please note that our internet address is being provided for reference only and no information contained therein is incorporated by reference into our Exchange Act filings. ITEM 1A. RISK FACTORS You should carefully consider and evaluate all of the information in, or incorporated by reference in, this annual report on Form 10-K. The following are among the risks we face related to our business, assets and operations. They are not the only ones we face. Any of these risks could materially and adversely affect our business, results of operations and financial condition, which in turn could materially and adversely affect the value of the securities being offered by this report. This section of the annual report on Form 10-K contains forward-looking statements of our plans, objectives, expectations and intentions. We use words such as "anticipate," "believe," "expect," future" and "intend" and similar expressions to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks factors described below and elsewhere in this report. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this report. RISKS RELATED TO DUSA WE ARE NOT CURRENTLY PROFITABLE AND MAY NOT BE PROFITABLE IN THE FUTURE UNLESS WE CAN SUCCESSFULLY MARKET AND SELL SIGNIFICANTLY HIGHER QUANTITIES OF OUR APPROVED PRODUCTS, THE LEVULAN(R) KERASTICK(R) WITH THE BLU-U(R) BRAND LIGHT SOURCE FOR THE TREATMENT OF AKS OF THE FACE OR SCALP, AND THE BLU-U(R) WITHOUT LEVULAN(R) FOR THE TREATMENT OF MODERATE INFLAMMATORY ACNE. WE HAVE ONLY LIMITED EXPERIENCE MARKETING AND SELLING PHARMACEUTICAL PRODUCTS AND, AS A RESULT, OUR REVENUES FROM PRODUCT SALES MAY SUFFER. If we are unable to successfully market and sell sufficient quantities of our products, revenues from product sales will be lower than anticipated and our financial condition may be adversely affected. We are responsible for marketing our approved dermatology products in the United States and the rest of the world, except Canada, and Mexico and Central and South America, where we have distributors. We are doing so without the experience of having marketed pharmaceutical products prior to 2000. In October 2003, DUSA began hiring a small direct sales force and we increased the size of our sales force to market our products in the United States. Acquiring and retaining marketing and sales force capabilities involves significant expense, and current sales levels are not offsetting the expenses related to these efforts. If our sales and marketing efforts fail, then sales of the Kerastick(R) and the BLU-U(R) will be adversely affected. 26 IF WE CANNOT IMPROVE PHYSICIAN REIMBURSEMENT AND/OR CONVINCE MORE PRIVATE INSURANCE CARRIERS TO ADEQUATELY REIMBURSE PHYSICIANS FOR OUR THERAPY, SALES OF OUR LEVULAN(R) KERASTICK(R) FOR AKS MAY SUFFER. Without adequate levels of reimbursement by government health care programs and private health insurers, the market for our Levulan(R) Kerastick(R) for AK therapy will be limited. While we continue to support efforts to improve reimbursement levels to physicians and are working with the major private insurance carriers to improve coverage for our therapy, if our efforts are not successful, adoption of our therapy and sales of our products could be negatively impacted. Although 2005 reimbursement changes related to AK were made, some physicians still believe that reimbursement levels do not fully reflect the required efforts to routinely execute our therapy in their practices. SINCE WE NOW OPERATE THE ONLY FDA APPROVED MANUFACTURING FACILITY FOR THE KERASTICK(R) AND CONTINUE TO RELY HEAVILY ON SOLE SUPPLIERS FOR THE MANUFACTURE OF LEVULAN(R) AND THE BLU-U(R), ANY SUPPLY OR MANUFACTURING PROBLEMS COULD NEGATIVELY IMPACT OUR SALES. If we experience problems producing Kerastick(R) units in our facility, or if either of our contract suppliers fail to supply DUSA's requirements of Levulan(R) or the BLU-U(R), our business, financial condition and results of operations would suffer. Although we have received approval by the FDA to manufacture the BLU-U(R) in our Wilmington, Massachusetts facility, at this time we expect to utilize our own facility only as a back-up to our current third party manufacturer or for repairs. Manufacturers and their subcontractors often encounter difficulties when commercial quantities of products are manufactured for the first time, or large quantities of new products are manufactured, including problems involving: o product yields, o quality control, o component and service availability, o compliance with FDA regulations, and o the need for further FDA approval if manufacturers make material changes to manufacturing processes and/or facilities. We cannot guarantee that problems will not arise with production yields, costs or quality as we and our suppliers seek to increase production. Any manufacturing problems could delay or limit our supplies which would hinder our marketing and sales efforts. If our facility, any facility of our contract manufacturers, or any equipment in those facilities is damaged or destroyed, we may not be able to quickly or inexpensively replace it. Likewise, if there are any quality or supply problems with any components or materials needed to manufacturer our products, we may not be able to quickly remedy the problem(s). Any of these problems could cause our sales to suffer. 27 ANY FAILURE TO COMPLY WITH ONGOING GOVERNMENTAL REGULATIONS IN THE UNITED STATES AND ELSEWHERE WILL LIMIT OUR ABILITY TO MARKET OUR PRODUCTS. Both the manufacture and marketing of our products, the Levulan(R) Kerastick(R) with the BLU-U(R) for AKs and the BLU-U(R) without Levulan(R) to treat moderate inflammatory acne, are subject to continuing FDA review as well as comprehensive regulation by the FDA and by state and local regulatory authorities. These laws require, among other things: o approval of manufacturing facilities, including adherence to good manufacturing and laboratory practices during production and storage, o controlled research and testing of products even after approval, and o control of marketing activities, including advertising and labeling. If we, or any of our contract manufacturers, fail to comply with these requirements, we may be limited in the jurisdictions in which we are permitted to sell our products. Additionally, if we or our manufacturers fail to comply with applicable regulatory approval requirements, a regulatory agency may also: o send us warning letters, o impose fines and other civil penalties on us, o seize our products, o suspend our regulatory approvals, o refuse to approve pending applications or supplements to approved applications filed by us, o refuse to permit exports of our products from the United States, o require us to recall products, o require us to notify physicians of labeling changes and/or product related problems, o impose restrictions on our operations, and/or o criminally prosecute us. We and our manufacturers must continue to comply with the FDA's Good Manufacturing Practice, commonly known as cGMP, and Quality System Regulation, or QSR, and equivalent foreign regulatory requirements. The cGMP requirements govern quality control and documentation policies and procedures. In complying with cGMP and foreign regulatory requirements, we and our third-party manufacturers will be obligated to expend time, money and effort in production, record keeping and quality control to assure that our products meet applicable specifications and other requirements. As part of our FDA approval for the Levulan(R) Kerastick(R) for AK, we were required to conduct two Phase IV follow-up studies. We successfully completed the first study; and submitted our final report on the second study to the FDA in January 2004. The FDA could request additional information and/or studies. Additionally, if previously unknown problems with the product, a manufacturer or its facility are 28 discovered in the future, changes in product labeling restrictions or withdrawal of the product from the market may occur. Manufacturing facilities are subject to ongoing periodic inspection by the FDA, including unannounced inspections. We cannot guarantee that our third-party supply sources, or our own Kerastick(R) facility, will continue to meet all applicable FDA regulations. If we, or any of our manufacturers, fail to maintain compliance with FDA regulatory requirements, it would be time consuming and costly to remedy the problem(s) or to qualify other sources. These consequences could have an adverse effect on our financial condition and operations. IF PRODUCT SALES DO NOT INCREASE SIGNIFICANTLY WE MAY NOT BE ABLE TO ADVANCE DEVELOPMENT OF OUR OTHER POTENTIAL PRODUCTS AS QUICKLY AS WE WOULD LIKE TO, WHICH WOULD DELAY THE APPROVAL PROCESS AND MARKETING OF NEW POTENTIAL PRODUCTS. If we do not generate sufficient revenues from our approved products, we may be forced to delay or abandon some or all of our product development programs. The pharmaceutical development and commercialization process is time consuming and costly, and any delays might result in higher costs which could adversely affect our financial condition. Without sufficient product sales, we might be required to seek additional funding. There is no guarantee that adequate funding sources could be found to continue the development of all our potential products. We might be required to commit substantially greater capital than we have available to research and development of such products and we may not have sufficient funds to complete all or any of our development programs. THE COMMERCIAL SUCCESS OF ANY PRODUCTS THAT WE MAY DEVELOP WILL DEPEND UPON THE DEGREE OF MARKET ACCEPTANCE OF OUR PRODUCTS AMONG PHYSICIANS, PATIENTS, HEALTH CARE PAYORS, PRIVATE HEALTH INSURERS AND THE MEDICAL COMMUNITY. Our ability to commercialize any products that we may develop will be highly dependent upon the extent to which these products gain market acceptance among physicians, patients, health care payors, such as Medicare and Medicaid, private health insurers, including managed care organizations and group purchasing organizations, and the medical community. If these products do not achieve an adequate level of acceptance, we may not generate material product revenues, and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including: o the effectiveness, or perceived effectiveness, of our products in comparison to competing products; o the existence of any significant side effects, as well as their severity in comparison to any competing products; o potential advantages over alternative treatments; o the ability to offer our products for sale at competitive prices; o relative convenience and ease of administration; o the strength of marketing and distribution support; and o sufficient third-party coverage or reimbursement. 29 WE HAVE SIGNIFICANT LOSSES AND ANTICIPATE CONTINUED LOSSES FOR THE FORESEEABLE FUTURE. We have a history of operating losses. We expect to have continued losses through at least 2006 as we attempt to increase sales of our approved products in the marketplace and continue research and development of potential new products. We incurred net losses of $15,628,980 for the year ended December 31, 2004 and net losses of $14,998,709 for the year ended December 31, 2005. As of December 31, 2005, our accumulated deficit was approximately $89,537,000. We cannot predict whether any of our products will achieve significant enough market acceptance or generate sufficient revenues to enable us to become profitable. IF WE ARE UNABLE TO PROTECT OUR PROPRIETARY TECHNOLOGY, TRADE SECRETS OR KNOW-HOW, WE MAY NOT BE ABLE TO OPERATE OUR BUSINESS PROFITABLY. WE HAVE LIMITED PATENT PROTECTION AND IF WE ARE UNABLE TO PROTECT OUR PROPRIETARY RIGHTS, COMPETITORS MIGHT BE ABLE TO DEVELOP SIMILAR PRODUCTS TO COMPETE WITH OUR PRODUCTS AND TECHNOLOGY. Our ability to compete successfully depends, in part, on our ability to defend patents that have issued, obtain new patents, protect trade secrets and operate without infringing the proprietary rights of others. We have no compound patent protection for our Levulan(R) brand of the compound ALA. Our basic patents are for methods of detecting and treating various diseased tissues using ALA (or related compounds called precursors), in combination with light. We own or exclusively license patents and patent applications related to the following: o methods of using ALA and its unique physical forms in combination with light, o compositions and apparatus for those methods, and o unique physical forms of ALA. We have limited patent protection outside the United States, which may make it easier for third-parties to compete there. Our basic method of treatment patents and applications have counterparts in only six foreign countries, and certain countries under the European Patent Convention. Even where we have patent protection, there is no guarantee that we will be able to enforce our patents. Additionally, enforcement of a given patent may not be practicable or an economically viable alternative. In 2002, we received notice of a lawsuit filed in Australia by PhotoCure ASA alleging that Australian Patent No. 624985, which is one of the patents licensed to us by PARTEQ Research & Development Innovations, the technology transfer arm of Queen's University at Kingston, Ontario, relating to our ALA technology, is invalid. As a consequence of this action, Queen's University assigned the Australian patent to DUSA so that we could participate directly in the litigation. On April 6, 2005, the Federal Court of Australia ruled that the patent is valid and remains in full force and effect. However, the Court also ruled that PhotoCure's product does not infringe the claims in the Australian patent. The parties signed a Mediation Agreement in August 2004 to attempt to settle their disputes and those discussions are ongoing. If the parties are unable to amicably resolve matters, patent litigation could ensue in the United States and there can be no guarantee that we would prevail. Some of the indications for which we are developing therapies may not be covered by the claims in any of our existing patents. Even with the issuance of additional patents to DUSA, other parties are free to develop other uses of ALA, including medical uses, and to market ALA for such uses, assuming that 30 they have obtained appropriate regulatory marketing approvals. ALA in the chemical form has been commercially supplied for decades, and is not itself subject to patent protection. There are reports of third-parties conducting clinical studies with ALA in countries outside the United States where PARTEQ does not have patent protection. In addition, a number of third-parties are seeking patents for uses of ALA not covered by our patents. These other uses, whether patented or not, and the commercial availability of ALA, could limit the scope of our future operations because ALA products could come on the market which would not infringe our patents but would compete with our Levulan(R) products even though they are marketed for different uses. While we attempt to protect our proprietary information as trade secrets through agreements with each employee, licensing partner, consultant, university, pharmaceutical company and agent, we cannot guarantee that these agreements will provide effective protection for our proprietary information. It is possible that: o these persons or entities might breach the agreements, o we might not have adequate remedies for a breach, and/or o our competitors will independently develop or otherwise discover our trade secrets. PATENT LITIGATION IS EXPENSIVE, AND WE MAY NOT BE ABLE TO AFFORD THE COSTS. The costs of litigation or any proceeding relating to our intellectual property rights could be substantial even if resolved in our favor. Some of our competitors have far greater resources than we do and may be better able to afford the costs of complex patent litigation. For example, third-party competitors may infringe one or more of our patents, and we could be required to spend significant resources to enforce our patent rights. Also, if we were to sue a third-party for infringement of our patents in the United States, that third-party could challenge the validity of our patent(s). We cannot guarantee that a third-party will not claim, with or without merit, that we have infringed their patent(s) or misappropriated their proprietary material. Defending this type of legal action involves considerable expense and could negatively affect our financial results. Additionally, if a third-party were to file a United States patent application in the United States, or be issued a patent claiming technology also claimed by us in a pending United States application(s), we may be required to participate in interference proceedings in the United States Patent and Trademark Office to determine the priority of the invention. A third-party could also request the declaration of a patent interference between one of our issued United States patents and one of its patent applications. Any interference proceedings likely would require participation by us and/or PARTEQ, could involve substantial legal fees and result in a loss or lessening of our patent protection. During 2005 and into 2006, we filed several lawsuits against compounding pharmacies and physicians alleging violations of patent law. While we have been successful in obtaining a default judgment against one compounding pharmacy and have obtained consent judgments from several physicians, we do not know whether these lawsuits will prevent others from infringing our patents or whether we will be successful in stopping these activities which we believe are negatively affecting our revenues. 31 WE HAVE ONLY TWO THERAPIES THAT HAVE RECEIVED REGULATORY APPROVAL OR CLEARANCE AND WE CANNOT PREDICT WHETHER WE WILL EVER DEVELOP OR COMMERCIALIZE ANY OTHER PRODUCTS. EXCEPT FOR THE LEVULAN(R) KERASTICK(R) WITH THE BLU-U(R) TO TREAT AKS, AND THE USE OF THE BLU-U(R) ALONE TO TREAT MODERATE INFLAMMATORY ACNE, ALL OF OUR POTENTIAL PRODUCTS ARE IN EARLY STAGES OF DEVELOPMENT AND MAY NEVER RESULT IN ANY COMMERCIALLY SUCCESSFUL PRODUCTS. We do not know if the Levulan(R) Kerastick(R) or the BLU-U(R) products will ever be commercially successful. To be profitable, we must successfully research, develop, obtain regulatory approval for, manufacture, introduce, market and distribute our products. Except for DUSA's two approved therapies, all of our other potential Levulan(R) and BLU-U(R) products are at an early stage of development and subject to the risks of failure inherent in the development of new pharmaceutical products and products based on new technologies. These risks include: o delays in product development, clinical testing or manufacturing, o unplanned expenditures in product development, clinical testing or manufacturing, o failure in clinical trials or failure to receive regulatory approvals, o emergence of superior or equivalent products, o inability to market products due to third-party proprietary rights, and o failure to achieve market acceptance. We cannot predict how long the development of our investigational stage products will take or whether they will be medically effective. We cannot be sure that a successful market will continue to develop for our Levulan(R) drug technology. WE MUST RECEIVE SEPARATE APPROVAL FOR EACH OF OUR POTENTIAL PRODUCTS BEFORE WE CAN SELL THEM COMMERCIALLY IN THE UNITED STATES OR ABROAD. All of our potential Levulan(R) products will require the approval of the FDA before they can be marketed in the United States. If we fail to obtain the required approvals for these products our revenues will be limited. Before an application to the FDA seeking approval to market a new drug, called an NDA, can be filed, a product must undergo, among other things, extensive animal testing and human clinical trials. The process of obtaining FDA approvals can be lengthy, costly, and time-consuming. Following the acceptance of an NDA, the time required for regulatory approval can vary and is usually 1 to 3 years or more. The FDA may require additional animal studies and/or human clinical trials before granting approval. Our Levulan(R) PDT products are based on relatively new technology. To the best of our knowledge, the FDA has approved only 3 drugs for use in photodynamic therapy, including Levulan(R). This factor may lengthen the approval process. We face much trial and error and we may fail at numerous stages along the way. We cannot predict whether we will obtain approval for any of our potential products. Data obtained from preclinical testing and clinical trials can be susceptible to varying interpretations which could delay, limit or prevent regulatory approvals. Future clinical trials may not show that Levulan(R) PDT or photodetection, known as PD, is safe and effective for any new use we are studying. In addition, delays or disapprovals may be encountered based upon additional governmental regulation resulting from future legislation or administrative action or changes in FDA policy. During September 2005, the FDA issued 32 guidance for the pharmaceutical industry regarding the development of new drugs for acne vulgaris treatment. As a result, it is likely that the costs and time to approval associated with seeking regulatory approval of this indication will be increased. The FDA may issue additional guidance in the future, which may result on additional costs and delays. We must also obtain foreign regulatory clearances before we can market any potential products in foreign markets. The foreign regulatory approval process includes all of the risks associated with obtaining FDA marketing approval and may impose substantial additional costs. IF WE ARE UNABLE TO OBTAIN THE NECESSARY CAPITAL TO FUND OUR OPERATIONS, WE WILL HAVE TO DELAY OUR DEVELOPMENT PROGRAMS AND MAY NOT BE ABLE TO COMPLETE OUR CLINICAL TRIALS. Since our current sales goals for our products may not be met in the future, we may need substantial additional funds to fully develop, manufacture, market and sell our other potential products. We may obtain funds through other public or private financings, including equity financing, and/or through collaborative arrangements. We cannot predict whether any financing will be available at all or on acceptable terms. Dependent on the extent of available funding, we may delay, reduce in scope or eliminate some of our research and development programs. We may also choose to license rights to third parties to commercialize products or technologies that we would otherwise have attempted to develop and commercialize on our own which could reduce our potential revenues. WE ARE EXPOSED TO RISKS ASSOCIATED WITH ACQUISITIONS. On December 30, 2005 we entered into a Merger Agreement with Sirius Laboratories, Inc. The transaction is expected to close during the first quarter of 2006, subject to the terms and conditions in the Merger Agreement. We may in the future make other acquisitions of, or significant investments in, businesses with complementary products, services and/or technologies. Acquisitions involve numerous risks, including, but not limited to: o difficulties and increased costs in connection with integration of the personnel, operations, technologies and products of acquired companies; o diversion of management's attention from other operational matters; o the potential loss of key employees; o the potential loss of key collaborators; o lack of synergy, or the inability to realize expected synergies, resulting from the acquisition; o acquired intangible assets becoming impaired as a result of technological advancements or worse-than-expected performance of the acquired company; o the potential for unexpected liabilities; and o use of cash which could be difficult to replace on reasonable terms. Mergers and acquisitions are inherently risky, and the inability to effectively manage these risks could materially and adversely affect our business, financial condition and results of operations. 33 BECAUSE OF THE NATURE OF OUR BUSINESS, THE LOSS OF KEY MEMBERS OF OUR MANAGEMENT TEAM COULD DELAY ACHIEVEMENT OF OUR GOALS. We are a small company with only 66 employees, including 2 part-time employees as of December 31, 2005. We are highly dependent on several key officer/employees with specialized scientific and technical skills without whom our business, financial condition and results of operations would suffer. The photodynamic therapy industry is still quite small and the number of experts is limited. The loss of these key employees could cause significant delays in achievement of our business and research goals since very few people with their expertise could be hired. Our growth and future success will depend, in large part, on the continued contributions of these key individuals as well as our ability to motivate and retain other qualified personnel in our specialty drug and light device areas. OUR COLLABORATIONS WITH OUTSIDE SCIENTISTS MAY BE SUBJECT TO RESTRICTION AND CHANGE. We work with scientific and clinical advisors and collaborators at academic and other institutions that assist us in our research and development efforts. These scientists and advisors are not our employees and may have other commitments that limit their availability to us. Although our advisors and collaborators generally agree not to do competing work, if a conflict of interest between their work for us and their work for another entity arises, we may lose their services. In addition, although our advisors and collaborators sign agreements not to disclose our confidential information, it is possible that valuable proprietary knowledge may become publicly known through them. RISKS RELATED TO OUR INDUSTRY PRODUCT LIABILITY AND OTHER CLAIMS AGAINST US MAY REDUCE DEMAND FOR OUR PRODUCTS OR RESULT IN DAMAGES. WE ARE SUBJECT TO RISK FROM POTENTIAL PRODUCT LIABILITY LAWSUITS WHICH COULD NEGATIVELY AFFECT OUR BUSINESS. The development, manufacture and sale of medical products exposes us to product liability claims related to the use or misuse of our products. Product liability claims can be expensive to defend and may result in significant judgments against us. A successful claim in excess of our insurance coverage could materially harm our business, financial condition and results of operations. Additionally, we cannot guarantee that continued product liability insurance coverage will be available in the future at acceptable costs. If the cost is too high, we may have to self-insure. OUR BUSINESS INVOLVES ENVIRONMENTAL RISKS AND WE MAY INCUR SIGNIFICANT COSTS COMPLYING WITH ENVIRONMENTAL LAWS AND REGULATIONS. We have used various hazardous materials, such as mercury in fluorescent tubes in our research and development activities. We are subject to federal, state and local laws and regulations which govern the use, manufacture, storage, handling and disposal of hazardous materials and specific waste products. Now that we have established our own production line for the manufacture of the Kerastick(R), we are subject to additional environmental laws and regulations. We believe that we are in compliance in all material respects with currently applicable environmental laws and regulations. However, we cannot guarantee that we will not incur significant costs to comply with environmental laws and regulations in the future. We also cannot guarantee that current or future environmental laws or regulations will not materially adversely affect our operations, business or assets. In addition, although we believe our safety 34 procedures for handling and disposing of these materials comply with federal, state and local laws and regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event of such an accident, we could be held liable for any resulting damages, and this liability could exceed our resources. WE MAY NOT BE ABLE TO COMPETE AGAINST TRADITIONAL TREATMENT METHODS OR KEEP UP WITH RAPID CHANGES IN THE BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRIES THAT COULD MAKE SOME OR ALL OF OUR PRODUCTS NON-COMPETITIVE OR OBSOLETE. COMPETING PRODUCTS AND TECHNOLOGIES BASED ON TRADITIONAL TREATMENT METHODS MAY MAKE SOME OR ALL OF OUR PROGRAMS OR POTENTIAL PRODUCTS NONCOMPETITIVE OR OBSOLETE. Well-known pharmaceutical, biotechnology and medical device companies are marketing well-established therapies for the treatment of many of the same conditions that we are seeking to treat, including AKs, acne, photodamaged skin and Barrett's esophagus. Doctors may prefer to use familiar methods, rather than trying our products. Reimbursement issues affect the economic competitiveness of our products as compared to other more traditional therapies. If PhotoCure enters the United States marketplace with its PDT product, our sales revenues may decline. Many companies are also seeking to develop new products and technologies, and receiving approval for medical conditions for which we are developing treatments. Our industry is subject to rapid, unpredictable and significant technological change. Competition is intense. Our competitors may succeed in developing products that are safer or more effective than ours. Many of our competitors have substantially greater financial, technical and marketing resources than we have. In addition, several of these companies have significantly greater experience than we do in developing products, conducting preclinical and clinical testing and obtaining regulatory approvals to market products for health care. We cannot guarantee that new drugs or future developments in drug technologies will not have a material adverse effect on our business. Increased competition could result in: o price reductions, o lower levels of third-party reimbursements, o failure to achieve market acceptance, and o loss of market share, any of which could adversely affect our business. Further, we cannot give any assurance that developments by our competitors or future competitors will not render our technology obsolete. OUR PRODUCTS MAY LOSE MARKET SHARE IF NEW MANUFACTURERS BEGIN PRODUCING COMPETING PRODUCTS THAT ARE ABLE TO PENETRATE OUR MARKET. WE HAVE LEARNED THAT COMPOUNDING PHARMACIES ARE PRODUCING A FORM OF AMINOLEVULINIC ACID HCL AND ARE MARKETING IT TO THE MEDICAL COMMUNITY. We are aware that there are compounding pharmacies that market compounded versions of aminolevulinic acid HCl as an alternative to our Levulan(R) product. On January 31, 2005, we filed a 35 lawsuit in the United States District Court for the District of Arizona against The Cosmetic Pharmacy of Tucson, Arizona alleging violations of the Lanham Act for false advertising and trademark infringement and of United States patent law. A motion for default judgment was granted on July 25, 2005 in our favor for failure of The Cosmetic Pharmacy of Tucson to appear, together with injunctive relief and attorney fees and costs in the amount of approximately $20,700. Also, on December 27, 2004, we filed a lawsuit in United States District Court for the District of Massachusetts against New England Compounding Pharmacy, Inc. of Framingham, Massachusetts alleging violations of United States patent law. New England Compounding Pharmacy has filed an answer, including a defense alleging invalidity of our patents, and several counterclaims against us, and we have filed our response. The parties are now in the discovery stage of this litigation and we have been unable to predict the outcome of the lawsuit at this time. A tentative trial date has been set by the court for January 2007. We cannot be certain whether we will be successful in defending such counterclaims, however, we have not accrued any amounts for settlement at this time. While we believe that certain actions of these pharmacies go beyond the activities which are permitted under the Food, Drug and Cosmetic Act and have advised the FDA and local health authorities of our concerns, we cannot be certain that our lawsuits will be successful in curbing the practices of these pharmacies or that regulatory authorities will intervene to stop their activities. In addition, there may be other compounding pharmacies which are following FDA guidelines, or others conducting illegal activities of which we are not aware, which may be negatively impacting our sales revenues. OUR PDT/PD COMPETITORS IN THE BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRIES MAY HAVE BETTER PRODUCTS, MANUFACTURING CAPABILITIES OR MARKETING EXPERTISE. We anticipate that we will face increased competition as the scientific development of PDT/PD advances and new companies enter our markets. Several companies are developing PDT agents other than Levulan(R). These include: QLT Inc. (Canada); Axcan Pharma Inc. (U.S.); Miravant, Inc. (U.S.); and Pharmacyclics, Inc. (U.S.). We are also aware of several companies commercializing and/or conducting research with ALA or ALA-related compounds, including: medac GmbH and photonamic GmbH & Co. KG (Germany); PhotoTherapeutics, Inc. (U.K.) and PhotoCure ASA (Norway) which entered into a marketing agreement with Galderma S.A. for countries outside of Nordic countries for certain dermatology indications. PhotoCure has received marketing approval of its ALA precursor (ALA methyl-ester) compound for PDT treatment of AKs and basal cell carcinoma in the European Union, New Zealand, Australia and countries in Scandinavia. In July 2004, PhotoCure received FDA approval in the United States for its AK therapy. If PhotoCure enters into the marketplace based on receiving approval, its product will represent direct competition for our products. Axcan Pharma Inc. has received FDA approval for the use of its product, PHOTOFRIN(R), for PDT in the treatment of high grade dysplasia associated with Barrett's esophagus. Axcan is the first company to market a PDT therapy for this indication, which we are also pursuing. We expect that our principal methods of competition with other PDT companies will be based upon such factors as: o the ease of administration of our method of PDT, o the degree of generalized skin sensitivity to light, o the number of required doses, 36 o the selectivity of our drug for the target lesion or tissue of interest, and o the type and cost of our light systems. RISKS RELATED TO OUR STOCK IF OUTSTANDING OPTIONS, WARRANTS AND RIGHTS ARE CONVERTED, THE VALUE OF THOSE SHARES OF COMMON STOCK OUTSTANDING JUST PRIOR TO THE CONVERSION WILL BE DILUTED. As of March 1, 2006 there were outstanding options and warrants to purchase 2,867,875 shares of common stock, with exercise prices ranging from U.S. $1.60 to $31.00 per share, and of CDN $6.79 per share, respectively. The holders of the options and warrants have the opportunity to profit if the market price for the common stock exceeds the exercise price of their respective securities, without assuming the risk of ownership. The holders are likely to exercise their securities when we would probably be able to raise capital from the public on terms more favorable than those provided in these securities. RESULTS OF OUR OPERATIONS AND GENERAL MARKET CONDITIONS FOR SPECIALTY PHARMACEUTICAL AND BIOTECHNOLOGY STOCKS COULD RESULT IN SUDDEN CHANGES IN THE MARKET VALUE OF OUR STOCK. The price of our common stock has been highly volatile. These fluctuations create a greater risk of capital losses for our shareholders as compared to less volatile stocks. From January 1, 2005 to March 1, 2006, the price of our stock has ranged from a low of $6.57 to a high of $16.30. Factors that contributed to the volatility of our stock during the last 12 months included: o quarterly levels of product sales; o clinical trial results; o general market conditions; o increased marketing activities; and o changes in third-party payor reimbursement for our therapy. The significant general market volatility in similar stage pharmaceutical and biotechnology companies made the market price of our common stock even more volatile. SIGNIFICANT FLUCTUATIONS IN ORDERS FOR OUR PRODUCTS, ON A MONTHLY AND QUARTERLY BASIS, ARE COMMON BASED ON EXTERNAL FACTORS AND SALES PROMOTION ACTIVITIES. THESE FLUCTUATIONS COULD INCREASE THE VOLATILITY OF OUR STOCK PRICE. The price of our common stock may be affected by the amount of quarterly shipments of our products to end-users. Since our products are still in the early stages of adoption, and sales volumes are still low, a number of factors could affect product sales levels and growth rates in any period. These could include the timing of medical conferences, sales promotion activities, and large volume purchases by our higher usage customers. In addition, seasonal fluctuations in the number of patients seeking treatment at various times during the year could impact sales volumes. These factors could, in turn, affect the volatility of our stock price. 37 EFFECTING A CHANGE OF CONTROL OF DUSA WOULD BE DIFFICULT, WHICH MAY DISCOURAGE OFFERS FOR SHARES OF OUR COMMON STOCK. Our certificate of incorporation authorizes the board of directors to issue up to 100,000,000 shares of stock, 40,000,000 of which are common stock. The board of directors has the authority to determine the price, rights, preferences and privileges, including voting rights, of the remaining 60,000,000 shares without any further vote or action by the shareholders. The rights of the holders of our common stock will be subject to, and may be adversely affected by, the rights of the holders of any preferred stock that may be issued in the future. On September 27, 2002, we adopted a shareholder rights plan at a special meeting of DUSA's board of directors. The rights plan could discourage, delay or prevent a person or group from acquiring 15% or more (or 20% or more in the case of certain parties) of our common stock, thereby limiting, perhaps, the ability of our shareholders to benefit from such a transaction. The rights plan provides for the distribution of one right as a dividend for each outstanding share of our common stock to holders of record as of October 10, 2002. Each right entitles the registered holder to purchase one one-thousandths of a share of preferred stock at an exercise price of $37.00 per right. The rights will be exercisable subsequent to the date that a person or group either has acquired, obtained the right to acquire, or commences or discloses an intention to commence a tender offer to acquire, 15% or more of our outstanding common stock (or 20% of the outstanding common stock in the case of a shareholder or group who beneficially held in excess of 15% at the record date), or if a person or group is declared an "Adverse Person", as such term is defined in the rights plan. The rights may be redeemed by DUSA at a redemption price of one one-hundredth of a cent per right until ten days following the date the person or group acquires, or discloses an intention to acquire, 15% or 20% or more, as the case may be, of DUSA, or until such later date as may be determined by the our board of directors. Under the rights plan, if a person or group acquires the threshold amount of common stock, all holders of rights (other than the acquiring person or group) may, upon payment of the purchase price then in effect, purchase shares of common stock of DUSA having a value of twice the purchase price. In the event that we are involved in a merger or other similar transaction where DUSA is not the surviving corporation, all holders of rights (other than the acquiring person or group) shall be entitled, upon payment of the purchase price then in effect, to purchase common stock of the surviving corporation having a value of twice the purchase price. The rights will expire on October 10, 2012, unless previously redeemed. Our board of directors has also adopted certain amendments to DUSA's certificate of incorporation consistent with the terms of the rights plan. ITEM 1B. UNRESOLVED STAFF COMMENTS None. ITEM 2. PROPERTIES In May 1999, we entered into a five year lease for 16,000 sq. ft. of office/warehouse space to be used for offices and manufacturing in Wilmington, Massachusetts. In December 2001 we entered into a 15 year lease covering the entire building through November 2016. We have the ability to terminate the Wilmington lease after the 10th year (2011) of the lease by providing the landlord with notice at least 7 and one-half months prior to the date on which the termination would be effective. In October 2002, we entered into a five-year lease commitment for approximately 2,000 sq. ft., for our wholly-owned subsidiary, DUSA Pharmaceuticals New York, Inc., replacing the space DUSA previously occupied. 38 Commencing in August 2002, we entered into a five year lease for office space for our Toronto location which accommodates the Toronto office of our Chief Executive Officer and shareholder services representative. See "Note 12(c) to the Company's Notes to the Consolidated Financial Statements". ITEM 3. LEGAL PROCEEDINGS In April 2002, we received a copy of a notice issued by PhotoCure ASA to Queen's University at Kingston, Ontario, alleging that Australian Patent No. 624985 was invalid. Australian Patent No. 624985 is one of the patents covered by our agreement with PARTEQ Research & Development Innovations, the technology transfer arm of Queen's University, relating to 5-aminolevulinic acid technology. PhotoCure instituted this proceeding on April 12, 2002 in the Federal Court of Australia, Victoria District Registry. As a consequence of this action, Queen's University assigned the Australian patent to us so that we could participate directly in this litigation. On April 6, 2005, the Federal Court of Australia ruled that the patent is valid and remains in full force and effect. However, the Court also ruled that PhotoCure's product does not infringe the claims in the Australian patent. Since these claims are unique to the Australian patent and Australian law differs from patent law in other jurisdictions, we do not expect that this decision is determinative of the validity of any other patents licensed by us from Queen's University or of whether PhotoCure's product infringes claims in such other patents, including the United States patent. None of the parties have appealed the decision and the date to do so has expired. The parties, including PhotoCure's marketing partner, Galderma S.A., signed a Mediation Agreement in August 2004 to attempt to settle their disputes. The parties are negotiating a settlement agreement which is expected to be finalized in the first half of 2006. In December 2004, we filed a lawsuit against New England Compounding Center of Framingham, Massachusetts alleging violations of United States patent law in the United States Federal District Court in Boston, Massachusetts. On March 17, 2005, New England Compounding Pharmacy filed an answer against us, including a defense that our patents are invalid and several counterclaims against us, and we filed our response on April 5, 2005. The parties are now in the discovery stage of this litigation. A tentative trial date has been set by the court for January 2007. We are seeking injunctive relief, monetary damages and costs. In January 2005, we filed a lawsuit against The Cosmetic Pharmacy of Tucson, Arizona alleging violations of the Lanham Act for false advertising and trademark infringement, and of United States patent law in the United States District Court for the District of Arizona. A motion for default judgment was granted on July 25, 2005 in our favor for failure of The Cosmetic Pharmacy of Tucson to appear, together with injunctive relief and attorney fees and costs in the amount of approximately $20,700. In November of 2005 and January of 2006, we filed lawsuits against physicians in several states to prevent their continued use of versions of our Levulan (R) brand of aminolevulinic acid HCl (ALA) produced by compounding pharmacies, for use in our patented photodynamic therapy (PDT) treatment for actinic keratosis, basal cell carcinoma, acne and other dermatological conditions. The suits allege that ALA obtained from sources other than DUSA is being used by these physicians for patient treatments that are covered under patents exclusively licensed by DUSA, resulting in direct infringement of these patent(s). Additionally, some doctors are also being sued for misuse of DUSA's trademarks and for violations of the Lanham Act for using the Levulan (R) brand name on their web sites and promotional materials, but performing patient treatments with ALA obtained from other sources. Most of the physicians have entered Consent Judgments in which they admit the infringement and provide DUSA with the right to review their books and records. Two lawsuits are currently on-going. 39 For other patent matters, see section entitled "Risk Factors - If we are unable to protect our proprietary technology, trade secrets or know-how, we may not be able to operate our business profitably". ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our common stock is traded on the NASDAQ National Market under the symbol "DUSA." The following are the high and low sales prices for the common stock reported for the quarterly periods shown. Price range per common share by quarter, 2004:
First Second Third Fourth ------- ------- ------- ------- NASDAQ High $ 14.87 $ 13.50 $ 12.20 $ 14.41 Low 5.02 8.46 8.23 9.95
Price range per common share by quarter, 2005:
First Second Third Fourth ------- ------- ------- ------- NASDAQ High $ 16.30 $ 11.68 $ 11.33 $ 10.80 Low 8.70 8.33 8.50 8.67
On March 1, 2006, the closing price of our common stock was $7.42 per share on the NASDAQ National Market. On March 1, 2006, there were 634 holders of record of our common stock. We have never paid cash dividends on our common stock and have no present plans to do so in the foreseeable future. 40 ITEM 6. SELECTED FINANCIAL DATA The following information should be read in conjunction with our Consolidated Financial Statements and the Notes thereto and Management's Discussion and Analysis of Financial Condition and Results of Operations included elsewhere in this report. The selected financial data set forth below has been derived from our audited consolidated financial statements. CONSOLIDATED STATEMENTS OF OPERATIONS DATA
YEAR ENDED DECEMBER 31, ---------------------------------------------------------------------------- 2005 2004 2003 2002 (1) 2001 ------------- ------------- ------------- ------------ ------------- Revenues (1) $ 11,337,461 $ 7,987,656 $ 970,109 $ 25,483,238 $ 5,390,736 Net income (loss) (14,998,709) (15,628,980) (14,826,854) 5,762,518 (7,358,096) Basic and diluted net income (loss) per common share $ (0.89) $ (0.96) $ (1.06) $ 0.42 $ (0.53)
CONSOLIDATED BALANCE SHEETS DATA
AS OF DECEMBER 31, ---------------------------------------------------------------------------- 2005 2004 2003 2002 2001 ------------- ------------- ------------- ------------ ------------- Total assets $ 42,330,631 $ 56,650,888 $ 44,697,488 $ 60,949,973 $ 75,864,221 Long-term obligations - - 1,247,500 1,517,500 - Shareholders' equity 38,028,728 52,507,018 40,232,049 56,057,730 49,834,537
- ---------- (1) 2002 includes the recognition of approximately $20,990,000 in revenues, $2,638,000 in cost of product sales and $639,000 in research and development costs as a result of the termination of our former dermatology collaboration arrangement. These amounts were previously deferred and were being amortized into operations over periods ranging from 1 to 12.5 years. ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS When you read this section of this report, it is important that you also read the financial statements and related notes included elsewhere in this report. This section contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those we anticipate in these forward-looking statements for many reasons, including the factors described below and in "Risk Factors". OVERVIEW DUSA is a pharmaceutical company engaged primarily in the research, development and marketing of our first drug in combination with light devices to treat or detect a variety of conditions in processes known as photodynamic therapy or photodetection. Our drug, Levulan(R) brand of aminolevulinic acid HCl, or ALA, is being used with light, for use in a broad range of medical conditions. When we use Levulan(R) and follow it with exposure to light to treat a medical condition, it is known as Levulan(R) photodynamic therapy, or Levulan(R) PDT. When we use Levulan(R) and follow it with exposure to light to detect medical conditions it is known as Levulan(R) photodetection, or Levulan(R) PD. Our products, the Levulan(R) Kerastick(R) 20% Topical Solution with PDT and the BLU-U(R) brand light source were launched in the United States, or U.S., in September 2000 for the treatment of actinic keratoses, or AKs, of the face or scalp under a former dermatology collaboration. AKs are precancerous skin lesions caused by chronic sun exposure that can develop over time into a form of skin cancer called 41 squamous cell carcinoma. In addition, in September 2003 we received clearance from the United States Food and Drug Administration, or FDA, to market the BLU-U(R) without Levulan(R) PDT for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions. We are a vertically integrated company, primarily responsible for regulatory, sales, marketing, customer service, manufacturing of our Kerastick(R), and other related product activities. Our objectives include increasing the sales of our products in the United States and Canada, continuing our efforts of exploring partnership opportunities for Levulan(R) PDT for dermatology in Europe and/or other countries outside of the United States and Canada and Latin America and continuing our clinical development programs for our facial photodamage and moderate to severe acne indications. To further these objectives, we entered into a marketing and distribution agreement with Stiefel Laboratories, Inc. in January 2006 granting Stiefel an exclusive right to distribute the Levulan(R) Kerastick(R) in Mexico, Central and South America. During 2004 we signed clinical trial agreements with the National Cancer Institute, or NCI, Division of Cancer Prevention, or DCP, for the clinical development of Levulan(R) PDT for the treatment of high-grade dysplasia, or HGD, within Barrett's Esophagus, or BE, and oral cavity dysplasia treatment, and are working with the NCI DCP to advance the development of these programs. In addition, we continue to support independent investigator trials to advance research in the use and applicability of Levulan(R) PDT for other indications in dermatology, and selected internal indications. See sections entitled "Business - - Internal Indications" and "Business - Distribution". We are developing Levulan(R) PDT and PD under an exclusive worldwide license of patents and technology from PARTEQ Research and Development Innovations, the licensing arm of Queen's University, Kingston, Ontario, Canada. We also own or license certain other patents relating to methods for using pharmaceutical formulations which contain our drug and related processes and improvements. In the United States, DUSA(R), DUSA Pharmaceuticals, Inc.(R), Levulan(R), Kerastick(R) and BLU-U(R) are registered trademarks. Several of these trademarks are also registered in Europe, Australia, Canada, and in other parts of the world. Numerous other trademark applications are pending. See sections entitled "Business - Licenses; and - Patents and Trademarks". On December 30, 2005, we entered into a merger agreement to acquire all of the common stock of Sirius Laboratories, Inc. of Vernon Hills, Illinois in exchange for cash and common stock of DUSA worth up to $30,000,000. The transaction is expected to close during the first quarter of 2006, subject to the terms and conditions in the Merger Agreement. Of the up to $30,000,000, $8,000,000 less certain expenses will be paid in cash upon closing, $17,000,000 was paid in shares of DUSA's common stock also upon closing, and up to $5,000,000 in cash or common stock, as DUSA determines, may be paid based on a combination of new product approvals or launches, and achievement of certain pre-determined total cumulative sales milestones for Sirius products. The products acquired in this transaction, called the Sirius Merger, focus primarily on the treatment of acne vulgaris and acne rosacea. The DUSA shares are expected to be issued pursuant to Regulation D. The number of shares to be paid will be equal to $17,000,000 divided by the lesser of $10.10 or the average closing price of DUSA's shares on the NASDAQ Stock Market for the twenty (20) trading days prior to closing date. The closing is subject to certain closing conditions as previously disclosed which if not met, would provide a party the right to terminate the Merger Agreement. See section entitled "Business - General." If the Merger Agreement is terminated, a break-up fee in the amount of $250,000 might be due from one party to the other. In addition, DUSA has incurred approximately $800,000 of direct acquisition related costs which will affect the statement of operations if the transaction does not close. We cannot be certain that the merger will close. Historically, we devoted most of our resources to fund research and development efforts in order to advance the Levulan(R) PDT/PD technology platform. More recently, we have also devoted significant 42 resources to our sales and marketing efforts. As a result, we have experienced significant operating losses. During the quarter ended September 30, 2005, the Company eliminated 14 staff positions, representing 16% of the workforce, to align headcount more closely with management's assessment of its resource requirements at that time. These workforce reductions were made across all functions of the Company. As a result of these actions the Company recorded a restructuring charge of approximately $150,000. As of December 31, 2005, the Company had paid all of its obligations under the restructuring plan. As of December 31, 2005, we had an accumulated deficit of approximately $89,537,000. We expect to continue to incur operating losses until sales of our products increase substantially. Achieving our goal of becoming a profitable operating company is dependent upon greater acceptance of our therapy by the medical and consumer constituencies, and our ability to develop and/or acquire new profitable products. We operate in a highly regulated and competitive environment. Our competitors include larger fully integrated pharmaceutical companies and biotechnology companies. Many of the organizations competing with us have substantially greater capital resources, larger research and development staffs and facilities, greater experience in drug development and in obtaining regulatory approvals, and greater manufacturing and sales and marketing capabilities than we do. Marketing and sales activities since the October 2003 launch of our sales force have resulted in significant additional revenues as well as expenses. Kerastick(R) unit sales to end-users were 100,668 and 76,482 for the twelve months ended December 31, 2005 and 2004, respectively, consisting of 87,210 and 69,870 units sold in the U.S., and 13,458 and 6,612 units sold in Canada, in 2005 and 2004 respectively. A summary of quarterly Kerastick(R) unit sales to end users during the periods ended December 31, 2005 and 2004 is indicated below:
2005 ----------------------------------------------- Q1 Q2 Q3 Q4 TOTAL ------ ------ ------ ------ ------- UNITED STATES 24,900 16,506 17,766 28,038 87,210 CANADA 3,804 3,666 2,520 3,468 13,458 ------ ------ ------ ------ ------- TOTAL 28,704 20,172 20,286 31,506 100,668 ====== ====== ====== ====== =======
2004 ---------------------------------------------- Q1 Q2 Q3 Q4 TOTAL ------ ------ ------ ------ ------ UNITED STATES 12,054 16,002 18,870 22,944 69,870 CANADA - 1,908 1,326 3,378 6,612 ------ ------ ------ ------ ------ TOTAL 12,054 17,910 20,196 26,322 76,482 ====== ====== ====== ====== ======
The net number of BLU-U(R) units placed in doctors' offices during the twelve months ended December 31, 2005 and 2004 was 423 and 508, respectively, including 94 and 101 placed in Canada in 2005 and 2004, respectively. As of December 31, 2005 and 2004 there were 1,337 and 914 units in doctor's offices, consisting of 1,142 and 813 in the U.S. and 195 and 101 in Canada in 2005 and 2004, 43 respectively. In addition, during 2005 we began a BLU-U marketing effort to allow prospective customers to evaluate a BLU-U for a short period of time prior to making a purchase decision. BLU-U(R) commercial light sources placed in physicians' offices pursuant to the Company's BLU-U(R) evaluation program are classified as inventory in the accompanying Consolidated Balance Sheets. The Company amortizes the cost of the evaluation units during the evaluation period to cost of goods sold using an estimated useful life for the equipment of 3 years. We have continued our efforts to penetrate the market by expanding our sales coverage in key geographic locations. See section entitled "Management's Discussion and Analysis - Results of Operations, Marketing and Sales Costs". We are encouraged with the year-over-year increase in sales, as well as the positive feedback we continue to receive from physicians across the country that believe Levulan PDT should become a routine part of standard dermatological practice. We are currently exploring opportunities to develop, market, and distribute our Levulan(R) PDT platform in Europe and/or other countries outside of the United States and Canada following our recently completed agreement with Stiefel Laboratories, Inc. We are also continuing to seek to acquire and/or license additional dermatology products that complement our current product portfolio that would provide our sales force with additional complementary products to sell in the near term. We believe that the issues related to reimbursement have negatively impacted the economic competitiveness of our therapy with other AK therapies and have hindered its adoption in the past. We have continued to support efforts to improve reimbursement levels to physicians. Such efforts included working with the Centers for Medicare and Medicaid Services, or CMS, and the American Academy of Dermatology, or AAD, on matters related to the PDT procedure fee and the separate drug reimbursement fee. Doctors can also bill for any applicable visit fees. Effective January 1, 2006, the CMS average national reimbursement for the use of Levulan(R) PDT for AK's Ambulatory Patient Classifications code ("APC code") was increased. The APC code is used by many hospitals. The CMS Current Procedural Terminology code ("CPT code"), which is used by private physician clinics using Levulan(R) PDT for treating AKs was not increased for 2006 (i.e. it will be unchanged from 2005 levels). DUSA had expected reimbursement under the CPT code to increase on January 1, 2006; however, we now believe that the increase will not be effective until January 1, 2007 based on information from CMS and the AAD. We are aware that some physicians believe that reimbursement levels do not fully reflect the required efforts to routinely execute our therapy in their practices. We continue to support ongoing efforts that might lead to further increases in reimbursement in the future; and intend to continue supporting efforts to seek reimbursement for our FDA-cleared use of the BLU-U(R) alone in the treatment of mild to moderate inflammatory acne of the face. Most major private insurers have approved coverage for our AK therapy. We believe that due to these efforts, plus future improvements, along with our education and marketing programs, a more widespread adoption of our therapy should occur over time. We have been encouraged by the positive response from many physicians and patients who have used our therapy, but we recognize that we have to continue to demonstrate the clinical value of our unique therapy, and the related product benefits as compared to other well-established conventional therapies, in order for the medical community to accept our products on a large scale. While our financial position is strong, we cannot predict when product sales may offset the costs associated with these efforts. We are aware that physicians have been using Levulan(R) with the BLU-U(R) using short incubation, and with light devices manufactured by other companies, and for uses other than our FDA-approved use. While we are not permitted to market our products for so-called `off-label' uses, we believe that these activities are positively affecting the sales of our products. 44 We believe that some compounding pharmacies are exceeding the legal limits for their activities, including manufacturing and/or selling quantities of ALA in circumstances which may be inducing purchasers to infringe our intellectual property. We believe that these activities are negatively impacting our sales growth. Therefore in December 2004 and in January 2005, we filed lawsuits against two compounding pharmacies and several physicians. See section entitled "Legal Proceedings". As of December 31, 2005, we had a staff of 64 full-time employees and 2 part-time employee, as compared to 65 full-time employees and 4 part-time employees at the end of 2004, including marketing and sales, production, maintenance, customer support, and financial operations personnel, as well as those who support research and development programs for dermatology and internal indications. During 2005, we increased the size of our sales force to 26 from 22 at the end of 2004. During 2005 we eliminated 14 positions through a restructuring action, representing 16% of our workforce, to align headcount more closely with our assessment of our resource requirements at this time. These workforce reductions were made across all functions of the Company. We anticipate that this reduction in staff will reduce our future operating costs by $1,400,000 on an annualized basis. We may add and/or replace employees during 2006 as business circumstances deem necessary. 2005 TRANSACTIONS During 2005 and early 2006, DUSA entered into a number of transactions, all designed to foster future growth of its Levulan(R) PDT and early 2006 platform. ENTERED INTO EXCLUSIVE MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT WITH STIEFEL LABORATORIES - In January, 2006, we announced that we had entered into an exclusive Marketing, Distribution and Supply Agreement (the "Agreement") with Stiefel Laboratories, Inc. ("Stiefel") covering current and future uses of DUSA's proprietary Levulan(R) Kerastick(R) for photodynamic therapy (PDT) in dermatology. The Agreement, grants Stiefel an exclusive right to distribute, promote and sell the Levulan(R) Kerastick(R) in the western hemisphere from south of and including Mexico and all other countries in the Caribbean, excluding United States territories (collectively, the "Territory"). DUSA will manufacture and supply to Stiefel on an exclusive basis in the Territory all of Stiefel's reasonable requirements for the product. The Agreement, which has an initial term of ten years, will expand the distribution of Levulan(R) beyond the North American market for the first time into Mexico, Central and South America. DUSA has completed its portion of the Brazilian regulatory submission for the use of Levulan PDT for actinic keratoses. Effective with the signing of the Agreement, Stiefel will complete final integration and submission of the data to the Brazilian regulatory agency with market launch expected in late 2006 or early 2007. Stiefel will prepare and file the regulatory applications in other countries in the Territory subject to the terms of the Agreement. The parties have certain rights to terminate the Agreement prior to the end of the initial term, and Stiefel has an option to extend the term for an additional ten years on mutually agreeable terms and conditions. SIGNED MERGER AGREEMENT TO ACQUIRE SIRIUS LABORATORIES, INC. - In December, 2005, we signed a definitive Merger Agreement to acquire all of the common stock of Sirius Laboratories Inc. of Vernon Hills, Illinois in exchange for cash and common stock worth up to $30,000,000. Sirius is a privately held dermatology specialty pharmaceuticals company founded in 2000 with a primary focus on the treatment of acne vulgaris and acne rosacea. Closing of the transaction is expected in the first quarter of 2006, subject to the terms and conditions in the Merger Agreement. Of the up to $30,000,000, $8,000,000 less certain expenses will be paid in cash upon closing, $17,000,000 will be paid in shares of DUSA's common stock also upon closing in a private placement, and up to $5,000,000 in cash or common stock may be paid based on a combination of new product approvals or launches, and achievement of certain pre-determined total cumulative sales milestones for Sirius products. 45 LAWSUITS FILED FOR INFRINGEMENT OF OUR LEVULAN(R) PHOTODYNAMIC THERAPY PATENTS- In November 2005, we filed lawsuits against physicians in California, Florida, and Tennessee to prevent their continued use of versions of its Levulan(R) brand of aminolevulinic acid HCl (ALA) produced by compounding pharmacies, for use in DUSA's patented photodynamic therapy (PDT) treatment for actinic keratosis, basal cell carcinoma, acne and other dermatological conditions. Additionally, some doctors were sued for misuse of DUSA's trademarks and for violations of the Latham Act for using the Levulan(R) brand name on their web sites and promotional materials, but performing patient treatments with ALA obtained from other sources. We also sued two compounding pharmacies. CRITICAL ACCOUNTING POLICIES AND ESTIMATES Critical accounting policies are those that require application of management's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods and that can significantly affect our financial position and results of operations. Our accounting policies are disclosed in Note 2 to the Consolidated Financial Statements. We have discussed these policies and the underlying estimates used in applying these accounting policies with our Audit Committee. Since not all of these accounting policies require management to make difficult, subjective or complex judgments or estimates, they are not all considered critical accounting policies. We consider the following policies and estimates to be critical to our financial statements. REVENUE RECOGNITION - Revenues on product sales are recognized when persuasive evidence of an arrangement exists, the price is fixed and final, delivery has occurred, and there is reasonable expectation of collection. Product sales made through distributors have been recorded as deferred revenue until the product is sold by our distributors to the end user. Although we make every effort to assure the reasonableness of our estimates, significant unanticipated changes in our estimates due to business, economic, or industry events could have a material impact on our results of operations. INVENTORY - Inventories are stated at the lower of cost or market value. Cost is determined using the first-in, first-out method. Inventories are continually reviewed for slow moving, obsolete and excess items. Inventory items identified as slow-moving are evaluated to determine if an adjustment is required. Additionally, our industry is characterized by regular technological developments that could result in obsolete inventory. Although we make every effort to assure the reasonableness of our estimates, any significant unanticipated changes in demand, technological development, or significant changes to our business model could have a significant impact on the value of our inventory and our results of operations. We use sales projections to estimate the appropriate level of inventory reserves, if any, that are necessary at each balance sheet date. VALUATION OF LONG-LIVED AND INTANGIBLE ASSETS - We review long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Factors considered important which could trigger an impairment review include significant changes relative to: (i) projected future operating results; (ii) the use of the assets or the strategy for the overall business; (iii) business collaborations; and (iv) industry, business, or economic trends and developments. Each impairment test is based on a comparison of the undiscounted cash flow to the recorded value of the asset. If it is determined that the carrying value of long-lived or intangible assets may not be recoverable, the asset is written down to its estimated fair value on a discounted cash flow basis. At December 31, 2005 and 2004, respectively, total property, plant and equipment had a net carrying value of $2,972,000 and $3,482,000 including $2,233,000 at December 31, 2005 associated with our manufacturing facility. As of December 31, 2005 and 2004, respectively, we had intangible assets totaling $150,000 and $197,000 recorded in deferred charges and other assets 46 relating to the unamortized balance of payments made in 2004 to a light source supplier related to an amendment to our agreement and to a licensor related to the reacquisition of our product rights in Canada. STOCK-BASED COMPENSATION - Prior to January 1, 2006, we used the intrinsic value-based method to account for employee stock option awards under the provisions of Accounting Principles Board Opinion ("APB") No. 25, and to provide disclosures based on the fair value method in the Notes to the Consolidated Financial Statements as permitted by Statement of Financial Accounting Standards ("SFAS") No. 123, as amended. Stock or other equity-based compensation for non-employees is accounted for under the fair value-based method as required by SFAS No. 123 and Emerging Issues Task Force ("EITF") No. 96-18, "Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services" and other related interpretations. Under this method, the equity-based instrument is valued at either the fair value of the consideration received or the equity instrument issued on the date of grant. The resulting compensation cost is recognized and charged to operations over the service period which, in the case of stock options, is generally the vesting period. In December 2004, the Financial Accounting Standards Board ("FASB") issued SFAS No. 123(R), "Share-Based Payment," a revision of SFAS Statement No. 123. The Company adopted SFAS 123(R) effective January 1, 2006, using the modified prospective application method, and beginning with the first quarter of 2006 will be required to measure all employee share-based compensation awards using a fair value based method and record share-based compensation expense in its financial statements if the requisite service to earn the award is provided. The pro forma results and assumptions used in fiscal years 2005, 2004 and 2003 were based solely on historical volatility of our common stock over the most recent period commensurate with the estimated expected life of our stock options. The adoption of SFAS No. 123(R) will not affect the Company's cash flow, but it will materially increase the Company's net loss and basic and diluted loss per common share. In accordance with SFAS 123R, the Company will recognize the expense attributable to stock awards that are granted or vest in periods ending subsequent to December 31, 2005. For 2006, total stock-based compensation expense is estimated to be in the range of $1,500,000 to $2,500,000. In order to develop the fiscal 2006 stock-based compensation expense estimate, we utilized assumptions including, among other items, projected option grants, volatility measures using a combination of historical and current and historical implied volatility, and expected life estimates for officer and non-officer employee groups. The amount of the 2006 grants, if any, have not yet been determined and could result in a change to the amounts included in the range reflected above. Total unrecognized stock-based compensation expense related to unvested stock options, expected to be recognized over approximately two years, amounted to $3,300,000 at December 31, 2005 net of forfeitures. 47 RESULTS OF OPERATIONS YEAR ENDED DECEMBER 31, 2005 AS COMPARED TO 2004 REVENUES - Total revenues for the year ended December 31, 2005 were $11,337,000, as compared to $7,988,000 in 2004 and were comprised of the following:
2005 2004 INCREASE ------------ ------------ ------------ KERASTICK(R) REVENUES United States $ 7,957,000 $ 5,450,000 $ 2,507,000 Canada 935,000 401,000 534,000 ------------ ------------ ------------ Total $ 8,892,000 $ 5,851,000 $ 3,041,000 BLU-U(R) REVENUES United States $ 1,930,000 $ 1,795,000 $ 135,000 Canada 515,000 342,000 173,000 ------------ ------------ ------------ Total $ 2,445,000 $ 2,137,000 $ 308,000 ------------ ------------ ------------ Total product sales $ 11,337,000 $ 7,988,000 $ 3,349,000 ============ ============ ============
For the year ended December 31, 2005, overall Kerastick(R) unit sales to end-users were 100,668, including 87,210 sold in the United States and 13,458 sold in Canada by Coherent-AMT, our Canadian marketing and distribution partner. This represents an increase from 76,482 Kerastick(R) units sold in the year ended December 31, 2004, including 69,870 sold in the United States, and 6,612 sold in Canada by Coherent-AMT. The increase in Kerastick(R) revenues for 2005 compared with 2004 is attributable to increased sales volumes, an increase in our average unit selling price, increased levels of our direct distribution to customers and a reduction in our overall sales volume discount programs. Our average net selling price for the Kerastick(R) increased to $88.33 for 2005 from $76.50 in 2004. Our average net selling price for the Kerastick(R) includes sales made directly to our end-user customers, as well as sales made to our distributors, both in the United States and Canada. The increase in 2005 BLU-U(R) revenue was driven by an increase in our average selling price, which increased to $6,542 in 2005 from $4,368 in 2004. During 2005, there were 368 units sold versus 489 units in 2004. The 2005 total consists of 276 units sold in the United States and 92 units sold in Canada by Coherent-AMT. The 2004 total consists of 398 sold in the United States and 91 sold in Canada. The decrease in BLU-U(R) units sold in 2005 compared to 2004 is due primarily to the implementation of a more focused sales strategy aimed at increasing Kerastick(R) sales volumes in existing accounts; as well as a decrease in BLU-U(R) discounting programs. During the fourth quarter of 2005, we introduced a BLU-U(R) evaluation program, which, for a limited number of BLU-U(R) units, allows customers to take delivery of a unit for a period of up to 4 months for private practitioners and up to one year for hospital clinics, before a purchase decision is required. At December 31, 2005, there were 80 units in the field pursuant to this evaluation program. The units are classified as inventory in the financial statements and are being amortized during the evaluation period to cost of goods sold using an estimated life for the equipment of 3 years. Revenues pursuant to the evaluation program were not significant in 2005. The increase of both Kerastick(R) and BLU-U(R) revenues during 2005 is a result of the increased efforts of our sales force and related marketing and sales activities. With respect to United States sales, we increased our average selling prices, increased our direct selling and distribution efforts, while still maintaining the services of one external distributor, and reduced our overall sales volume discount programs, all of which have had a positive impact on our average selling prices during 2005. Sales must increase significantly from these levels in order for us to become profitable. We remain confident that we 48 are in a good position to exploit our therapy and that sales will continue to increase through increased consumption of the Kerastick(R) by our existing customers as well as the addition of new customers. COST OF PRODUCT SALES AND ROYALTIES - Cost of product sales and royalties for the year ended December 31, 2005 were $6,214,000, as compared to $3,875,000 in 2004. The components of cost of product sales and royalties for the years ended December 31, 2005 and 2004, including direct and indirect costs to support our product are provided below:
INCREASE KERASTICK(R) COST OF PRODUCT REVENUES AND ROYALTIES 2005 2004 (DECREASE) ---------- ---------- ---------- Direct Kerastick Product Costs $1,771,000 $1,478,000 $ 293,000 Other Kerastick(R) Product costs including internal costs assigned to support products 1,357,000 261,000 1,096,000 Royalty and Supply fees (1) 456,000 285,000 171,000 ---------- ---------- ---------- Total Kerastick(R) cost of product revenues and royalties $3,584,000 $2,024,000 $1,560,000 ========== ========== ==========
INCREASE/ BLU-U(R) COST OF PRODUCT REVENUES 2005 2004 (DECREASE) ---------- ---------- ---------- Direct BLU-U(R) Product costs (2) $1,249,000 $ - $1,249,000 Other BLU-U(R) Product costs including internal costs assigned to support products; as well as costs incurred to ship, install and service the BLU-U(R) in physicians offices 1,381,000 1,851,000 (470,000) ---------- ---------- ---------- Total BLU-U(R) cost of product revenues $2,630,000 $1,851,000 $ 779,000 ---------- ---------- ---------- TOTAL COST OF PRODUCT REVENUES AND ROYALTIES $6,214,000 $3,875,000 $2,339,000 ========== ========== ==========
- ---------- 1) Royalty and supply fees are paid to our licensor, PARTEQ Research and Development Innovations, the licensing arm of Queen's University, Kingston, Ontario, and starting in 2004, amortization of an upfront fee and a royalty are paid to Draxis, DUSA's former parent, on sales of the Levulan(R) Kerastick(R) in Canada. 2) Although there were direct BLU-U(R) product revenues in 2004, there were no related direct BLU-U(R) product costs as these units had a zero book value due to inventory impairment charges recorded during 2002. MARGINS - Total product margins for the year ended December 31, 2005, were $5,124,000 as compared to $4,113,000 for the year ended December 31, 2004, as shown below:
INCREASE/ 2005 2004 (DECREASE) ------------------ ---------------- ------------ Kerastick(R) $ 5,308,000 60% $ 3,827,000 65% $ 1,481,000 BLU-U(R) (184,000) (8)% 286,000 13% (470,000) ----------- ----------- ----------- Total Margin $ 5,124,000 45% $ 4,113,000 51% $ 1,011,000 =========== =========== ===========
49 Kerastick(R) margins for the year ended December 31, 2005, were 60% compared to 65% for the year ended December 31, 2004. The decrease in the Kerastick(R) margin percentage for the year ended December 31, 2005 is due primarily to an increase in unabsorbed manufacturing expenses incurred in 2005. In general, we have been operating our Kerastick(R) manufacturing plant well below capacity, resulting in underutilization charges, which have negatively impacted margins. Due to this situation, we are realizing fluctuations in our margins as a result of both the timing of production and unabsorbed expenses. This has been somewhat offset by an increase in the overall selling price per unit. Our long-term goal is to achieve higher margins on Kerastick(R) sales, which is significantly dependent on increased volume. BLU-U(R) margins for the year ended December 31, 2005, were (8)% compared with 13% for the year ended December 31, 2004. The erosion on margin is directly attributable to the fact that in 2005 we sold newly purchased units with an associated production cost, whereas during 2004 period, we sold units which had a zero net book value due to inventory impairment charges recorded during 2002 following termination of an agreement with a marketing partner. The margin erosion is somewhat offset by an increase in the overall selling price per unit and a decrease in Other BLU-U(R) Product costs. Our short-term strategy is to break-even on device sales in an effort to drive Kerastick(R) sales volumes. However, our longer term goal is to move towards a reasonable profit margin on all device sales. RESEARCH AND DEVELOPMENT COSTS - Research and development costs for the year ended December 31, 2005 and 2004 were $5,588,000 as compared to $6,490,000 in 2004. Contributing to the decrease in spending in 2005 compared with 2004 is the receipt of a refund from the FDA for our 2003 and 2004 product and registration fees in the amount of approximately $530,000.
INCREASE/ 2005 2004 (DECREASE) ------------ ----------- ------------ Research & Development costs incurred $ 6,118,000 $ 6,490,000 $ (372,000) Refund of FDA product and registration fees (530,000) - (530,000) ----------- ----------- ----------- Total Research and Development Expense $ 5,588,000 $ 6,490,000 $ (902,000) =========== =========== ===========
During the fourth quarter of 2004, we initiated a DUSA-sponsored Phase II study which we recently completed. This 72 patient, investigator blinded study was designed to examine various safety and efficacy parameters as a function of varying Levulan/vehicle incubation times, namely 15, 60 and 120 minutes. Patients were randomized within each incubation group so that 18 subjects received 'Levulan BLU-U' and six received `BLU-U alone'. There were no formal placebo arms in this study. Up to four PDT treatments were given at 2-week intervals. The primary efficacy parameters were the percent change in total acne lesion count for inflammatory, non-inflammatory, and total lesions at 4 and 8 weeks after the final PDT session. Acne severity scores (grades 0 - 4) were also assessed. Safety and tolerability were also followed throughout the study. The results of the study indicate that both `Levulan BLU-U' and `BLU-U alone' appear to effectively reduce the number of both inflammatory and non-inflammatory acne lesions. Given the higher than anticipated `BLU-U alone' response rate using this protocol, the study was not powered (sized) to discern differences between these arms. Using an intent-to-treat analysis, at the Week 8 time point, the median percent decrease in total lesion count, (inflammatory plus non-inflammatory) for Levulan BLU-U and BU-U alone was 61% and 80%, respectively. In the overall Acne Severity Assessment at the Week 8 time point, the Levulan BLU-U group showed 7/18 (39%) of subjects had at least 2 grades of improvement in their acne, compared with 4/6 (67%) in the BLU-U alone group. 50 In the group of 28 patients with the most severe (Grade 4) acne, which included those with the highest number of inflammatory lesions at baseline (> or = 60 lesions), the total lesion count at Week 8 decreased in the Levulan BLU-U group, whereas total lesion count at Week 8 increased in the BLU-U alone group. Treatment was well tolerated in both arms of the study with no unanticipated adverse events being reported. Side effects were minimal. In the 15-minute Levulan BLU-U group, no PDT treatments were discontinued due to pain, and at the Week 8 time-point, there were no significant differences between the groups in erythema, edema or hyperpigmentation. The results of this study suggest that for future development of the acne indication for Levulan PDT, those patients with the most severe form(s) of acne should receive the greatest benefit. In February 2006, we reported the interim analysis results from our 80 patient, multi-center Phase II split-face clinical study of PDT in the treatment of photodamaged skin using the Levulan(R) (aminolevulinic acid HCl, ALA) Kerastick(R) in combination with either the Company's BLU-U(R), an Intense Pulsed Light, or IPL, or a Long Pulsed Dye Laser, or LPDL, Each patient served as his or her own control, using a 'split-face' design. Following skin cleansing with an acetone solution, and approximately 60 minutes of drug and/or vehicle incubation, light treatment with a fixed dose was given using one of the three light sources. Up to 3 treatments were given, 3 weeks apart. Interim results were assessed at Weeks 9 and 12. The protocol includes additional follow-up visits scheduled for Weeks 26 and 52. The goal of the study was to guide selection of light source(s) for future development in the treatment of photodamaged skin, using the Company's proprietary Levulan PDT technology. The study was not designed to detect differences between the light sources. At Week 12, Levulan PDT with BLU-U light demonstrated material improvement in photodamaged skin, in comparison to BLU-U and vehicle. Statistical significance in net changes from baseline scores was achieved in 2 parameters of photodamage, namely mottled pigmentation (p=0.0348) and tactile roughness (p=0.0455). In addition, the trend toward improvement in a number of parameters was notably greater at Week 12 than Week 9, without any additional treatments with Levulan, which suggests that other parameters may also reach statistical significance over time. Specifically, Levulan with BLU-U showed greater improvements in mottled pigmentation, tactile roughness, fine wrinkling, sallowness and Global Photodamage Score (i.e. all the parameters that were measured except for telangiectasia (small blood vessels in the skin)), compared with areas treated with BLU-U and vehicle. BLU-U by itself is not known to have any effects on photodamaged skin. These results support the conclusions of a prior independent study by Touma et al (2004), using Levulan with BLU-U versus BLU-U alone, that achieved statistical significance with the addition of Levulan in all photodamage parameters measured, other than deep wrinkles. In that study, the investigators treated more severely sun-damaged patients, each with a minimum of 4 actinic keratoses. They also used twice the dose of blue light compared to the current study (10 vs. 5 Joules/cm2), and drug incubation times ranging from 1-3 hours. IPL by itself has previously been shown in independent studies to significantly improve photodamage, predominantly by targeting brown discoloration and red blood vessels. Therefore, as would be expected, at Week 12, significant improvement in photodamage was seen with IPL and vehicle, especially with respect to mottled pigmentation and telangiectasia. With the addition of Levulan, there was a trend toward even greater improvement in all parameters of photodamage except for mottled pigmentation, although these trends did not achieve statistical significance. However, similar to the BLU-U results, the trend toward improvement was notably greater at Week 12 than Week 9 without any additional treatments with Levulan, and additional follow up is scheduled at weeks 26 and 52. 51 These results support the conclusions of prior independent studies by Dover et al (2005), Alster et al (2005), and Gold et al (in press) using Levulan with IPL versus IPL alone for photodamage. All of these studies reported significant benefits from the addition of Levulan to IPL, especially in patients with significant photodamage. In addition, although IPL itself does not treat pre-cancerous cell damage, such as actinic keratoses, when combined with Levulan (ALA) to produce a PDT effect, IPL has been reported to effectively remove these lesions (Avram and Goldman, 2004, Ruiz-Rodrigues, 2002). With LPDL, as would be expected, there was significant improvement in photodamaged skin with LPDL and vehicle, especially with respect to telangiectasia, the primary target of this device. However, with LPDL, the addition of Levulan for the treatment of photodamage did not lead to any discernable differences in photodamage parameters between the two groups, as suggested by the results of an earlier study (Smith et al, 2004). In general, safety was excellent in all groups, but treatment using Levulan with BLU-U was better tolerated than treatment with IPL or LPDL (with or without Levulan) i.e. the frequency and severity of stinging and burning during treatment was greater with IPL and LPDL (with or without Levulan) compared to Levulan with BLU-U, and for BLU-U with vehicle. Levulan with BLU-U was also easy to use and less operator dependent. During September 2005, the FDA issued a new draft guidance for the pharmaceutical industry regarding the development of new drugs for acne vulgaris treatment. As a result of the issuance of this guidance, in combination with the results of our Phase II study, we believe that additional Phase II work will be required before we commence Phase III acne trials. As our Phase II clinical trials proceed, and especially at such time as we may commence Phase III trials in these indications, research and development expenses are expected to increase significantly. We have retained the services of a regulatory consultant to assist us with seeking foreign marketing approvals for our products, which could cause research and development expenses to increase. On September 27, 2004, DUSA signed a clinical trial agreement with the National Cancer Institute, Division of Cancer Prevention, or NCI DCP, for the clinical development of Levulan(R) PDT for the treatment of high-grade dysplasia within Barrett's Esophagus. In addition, to further our objectives concerning treatment of internal indications using Levulan(R) photodynamic therapy ("PDT"), on November 4, 2004, we signed an additional clinical trial agreement with the NCI DCP for the treatment of oral cavity dysplasia. DUSA and the NCI DCP are working together to prepare overall clinical development plans for Levulan(R) PDT in these indications, starting with Phase I/II trials, and continuing through Phase III studies, if appropriate. DUSA and the NCI DCP have prepared outlines of clinical studies in both indications. The NCI DCP is currently working with, DUSA and investigators to finalize the clinical trial designs. The NCI DCP will use its resources to file its own Investigational New Drug applications with the FDA. Our costs related to these studies will be limited to providing Levulan(R), device(s) and the necessary training for the investigators involved. All other costs of these studies will be the responsibility of the NCI DCP. We will maintain full ownership of our existing intellectual property, have options on new intellectual property and, subject to successful Phase II and III clinical trial results, intend to seek FDA approvals in due course. In preparation for new Phase II clinical trials for the treatment of high-grade dysplasia associated Barrett's esophagus, our small single-center pilot Phase II clinical trial using our new proprietary endoscopic light delivery device is continuing. We have entered into a series of agreements for our research projects and clinical studies. As of December 31, 2005, future payments to be made pursuant to these agreements, under certain terms and conditions, total approximately $1,775,000 for 2006. This amount does not include any amounts which may become due to photonamic GmbH & Co. KG under the terms of our License and Development Agreement. See Note 13(f) to the Notes to the Consolidated Financial Statements. We expect research 52 and development costs to increase in 2006 as compared to 2005 as we continue to invest in our clinical programs. MARKETING AND SALES COSTS -- Marketing and sales costs for the year ended December 31, 2005 were $9,069,000 as compared to $7,622,000 for 2004. These costs consist of overhead expenses such as salaries and benefits for the marketing and sales staff, commissions, and related support expenses such as travel, and telephone, totaling $6,934,000 in 2005 and $5,268,000 in 2004. These increases were mainly attributable to the expansion of our sales force during 2005 and related marketing activities. The remaining expenses consist of trade shows, miscellaneous marketing expenses and outside consultants totaling $2,135,000 in 2005 and $2,354,000 in 2004. For 2006, we expect marketing and sales costs will increase from 2005 levels reflecting our increased efforts to generate higher sales volumes; as well as, a full year impact of our sales force expansion that took place during 2005. GENERAL AND ADMINISTRATIVE COSTS -- General and administrative expenses for the year ended December 31, 2005, decreased to $6,703,000 as compared to $7,210,000 for 2004. The increase/decrease is mainly attributable to lower legal expenses of $1,902,000 as compared to $3,144,000 in the comparable period in 2004, due to the absence of patent litigation costs in Australia as the final hearing in the PhotoCure litigation described below was held in 2004. The savings related to the Australian litigation is partially offset by patent litigation costs against compounding pharmacies and physicians, as described below. Additionally, general corporate expenses, including increased personnel related costs, have increased as our business has expanded. For 2006, we expect general and administrative costs to be relatively consistent with 2005 levels. General and administrative costs are highly dependent on our legal expenses, which are difficult to predict. OTHER INCOME, NET -- Other income for the year ended December 31, 2005, decreased to $1,388,000, as compared to $1,580,000 in 2004. This decrease reflects a reduction in our average investable cash balances during 2005 as we used cash to support our operating activities. We expect other income, net will decrease in 2006 as we continue to use cash in support of our operations, our capital requirements and corporate transactions, particularly upon the expected closing of the merger with Sirius Laboratories, Inc. INCOME TAXES -- There is no provision for income taxes due to ongoing operating losses. As of December 31, 2005, we had net operating loss carryforwards of approximately $79,261,000 and tax credit carryforwards of approximately $2,521,000 for Federal reporting purposes. These amounts expire at various times through 2024. See Note 8 to the Notes to the Consolidated Financial Statements. We have provided a full valuation allowance against the net deferred tax assets at December 31, 2005 and 2004. NET LOSS -- For the year ended December 31, 2005, we recognized a net loss of $14,999,000, or $0.89 per share, as compared to $15,629,000, or $0.96 per share, for the year ended 2004. Net losses are expected to continue until product sales to physicians offset the cost of our sales force and marketing initiatives, and the costs for other business support functions. YEAR ENDED DECEMBER 31, 2004 AS COMPARED TO 2003 REVENUES -- Total revenues for the year ended December 31, 2004, were $7,988,000, as compared to $970,000 in 2003 and were comprised of the following: 53
2004 2003 INCREASE ---------- -------- ---------- KERASTICK(R) PRODUCT REVENUES United States $5,450,000 $901,000 $4,549,000 Canada 401,000 - 401,000 ---------- -------- ---------- Total $5,851,000 $901,000 $4,950,000 BLU-U(R) PRODUCT REVENUES United States $1,795,000 $ 69,000 $1,726,000 Canada 342,000 - 342,000 ---------- -------- ---------- Total $2,137,000 $ 69,000 $2,068,000 ---------- -------- ---------- Total Product Revenues $7,988,000 $970,000 $7,018,000 ========== ======== ==========
The increase in 2004 product revenues reflects sales to physicians of 76,482 Kerastick(R) units, as compared to 11,172 Kerastick(R) units in 2003, and an increase in the BLU-U(R) units in place in physician's offices of 914 units as of December 31, 2004, up from 406 units at December 31, 2004. With respect to U.S. Kerastick(R) sales, we increased our direct selling and distribution efforts, while still maintaining the services of one external distributor. On March 31, 2004, DUSA signed an exclusive marketing and distribution agreement for the Kerastick(R) and BLU-U(R) in Canada with Coherent-AMT Inc. ("Coherent"), a leading Canadian medical device and laser distribution company. Following receipt of regulatory approval from Health Canada, Coherent began marketing the BLU-U(R) for moderate inflammatory acne in April 2004, and the Kerastick(R) for the PDT treatment of non-hyperkeratotic actinic keratoses, or AKs, in June 2004. DUSA recognizes product sales when Coherent sells the Kerastick(R) and/or the BLU-U(R) to the end-user, as the price is fixed and final at that point. Kerastick(R) product sales through our Canadian distributor for the year ended December 31, 2004 were 6,612, and there were 101 BLU-U(R) units in physician's offices as of December 31, 2004. The increase of Kerastick(R) and BLU-U(R) revenues in the U.S. during 2004 is a result of the efforts of a larger sales force, and related marketing and sales activities. In addition, the increase in BLU-U(R) placements was caused, in part, by our ability to sell the BLU-U(R) to physicians as a stand alone device for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions following FDA clearance in September 2003. BLU-U(R) sales during the quarter ended December 31, 2004 decreased as expected, compared with the prior quarter, due to a planned price increase that became effective at the beginning of the fourth quarter, and a decreased emphasis on BLU-U(R) placements by our sales-force, in light of diminishing BLU-U(R) inventory levels at that time. We ordered additional BLU-U(R) units in the fourth quarter of 2004, and started to be re-supplied during the first quarter of 2005. As we experienced a backlog until the new supply of light sources started to become available, BLU-U(R) revenues were limited during the fourth quarter of 2004, and were limited until being re-supplied during the first quarter of 2005. Although the level of Kerastick(R) sales to end-users for 2004 was substantially higher than the level in the prior year, we significantly increased the size of our sales force and geographic reach during 2004. COST OF PRODUCT REVENUES AND ROYALTIES -- Cost of product revenues and royalties for the year ended December 31, 2004 were $3,875,000, as compared to $3,481,000 in 2003. The components of cost of product revenues and royalties for the years ended December 31, 2004 and 2003, including direct and indirect costs to support our product are provided below: 54 KERASTICK(R) COST OF PRODUCT REVENUES AND ROYALTIES
INCREASE 2004 2003 (DECREASE) ---------- ---------- ---------- Direct Kerastick(R) Product Cost s(1) $1,478,000 $216,000 $1,262,000 Other Kerastick Product costs including internal costs assigned to support products 261,000 1,972,000 (1,711,000) Royalty and supply fees (3) 285,000 74,000 211,000 ---------- ---------- ---------- Total Kerastick(R) cost of product revenues and royalties $2,024,000 $2,262,000 $ (238,000) ========== ========== ==========
BLU-U(R) COST OF PRODUCT REVENUES
INCREASE 2004 2003 (DECREASE) ---------- ---------- ---------- Other BLU-U(R) Product costs including internal costs assigned to support products; as well as costs incurred to ship, install and service the BLU-U(R) in physicians offices (2) 1,851,000 1,219,000 632,000 ---------- ---------- -------- Total BLU-U(R) cost of product revenues $1,851,000 $1,219,000 $632,000 TOTAL COST OF PRODUCT REVENUES AND ROYALTIES $3,875,000 $3,481,000 $394,000 ========== ========== ========
- ---------- (1)The decrease in product costs for 2004 primarily reflects the capitalization of labor and overhead associated with the manufacture of Kerastick(R) units in our facility. These costs were expensed in the prior year due to the absence of production. (2)Although there were direct BLU-U(R) product sales in 2004 and 2003, there were no related direct BLU-U(R) product costs as these units had a zero book value due to inventory impairment charges recorded during 2002. (3) Royalty and supply fees are paid to our licensor, PARTEQ Research and Development Innovations, the licensing arm of Queen's University, Kingston, Ontario, and starting in 2004, amortization of an upfront fee and a royalty are paid to Draxis, DUSA's former parent, on sales of the Levulan(R) Kerastick(R) in Canada. MARGINS -- Total product margins for the year ended December 31, 2004, were $4,113,000 as compared to $(2,511,000) for the year ended December 31, 2003, as shown below:
INCREASE/ 2004 2003 (DECREASE) ---------- ----------- ---------- Kerastick(R) $3,827,100 65% $(1,361,000) (151)% $5,188,000 BLU-U(R) 286,000 13% $(1,150,000) (1,660)% 1,436,000 ---------- ----------- ---------- Total Margin $4,113,000 51% $(2,511,000) (259)% $6,624,000 ========== =========== ==========
Kerastick(R) margins for the year ended December 31, 2004, were 65% compared to (151)% for the year ended December 31, 2004. The increase in the Kerastick(R) margins, in terms of both dollars and percentages, for the year ended December 31, 2004 is due primarily to the capitalization of labor and overhead associated with the manufacture of Kerastick(R) units in our facility in 2004. These costs were expensed in 2003 due to the absence of production. 55 BLU-U(R) margins for the year ended December 31, 2004, were 13% compared with (1,660) % for the year ended December 31, 2003. The increase in margin is directly attributable to increased BLU-U(R) revenues during 2004 with no associated direct costs, since the units being sold in both 2003 and 2004 had a zero book value due to an inventory impairment charge recorded in 2002. RESEARCH AND DEVELOPMENT COSTS -- Research and development costs for the year ended December 31, 2004, were $6,490,000 as compared to $5,404,000 in 2003. This increase reflects the preparation work associated with initiating the Phase II photodamaged skin trial, protocol finalization and initiation of our Phase II acne trial, and the start of our Phase II pilot study for Barrett's esophagus offset, in part, by lower third-party expenditures for our FDA mandated Phase IV clinical study of the long-term efficacy of the Kerastick(R). This FDA mandated Phase IV study was completed in late 2003 and we incurred only limited costs to file the final report with the FDA in 2004. We concentrated our dermatology development program on indications that use our approved Kerastick(R). Based on market research that was completed in 2003, we moved forward with our Phase II clinical studies for use of Levulan(R) PDT in photodamaged skin and moderate to severe acne vulgaris. We initiated the photodamaged skin study during the second quarter of 2004, and a Phase II study on Levulan(R) PDT for the treatment of acne vulgaris at the end of October 2004. In addition, 2004 expenses included compensation of $241,000 for the services of 3 consultants. These consultants originally received 30,000 fully vested stock options as compensation which were subsequently repurchased for $240,000 in December 2004 in response to new guidelines of pharmaceutical industry groups that prohibit physicians from having an ownership interest in companies with which they are affiliated. MARKETING AND SALES COSTS -- Marketing and sales costs for the year ended December 31, 2004, were $7,622,000 as compared to $2,494,000 for 2003. These costs consisted of overhead expenses such as salaries and benefits for the marketing and sales staff, commissions, and related support expenses such as travel, and telephone, totaling $5,268,000 in 2004 and $1,297,000 in 2003. The remaining expenses consisted of trade shows, miscellaneous marketing expenses and outside consultants totaling $2,354,000 in 2004 and $1,197,000 in 2003. These increases were mainly attributable to the launch of our direct sales force in October 2003 and related marketing and sales activities. As of December 31, 2004, our sales force was comprised of 22 direct sales professionals, including managers and representatives, and various independent representatives in key target markets. GENERAL AND ADMINISTRATIVE COSTS -- General and administrative expenses for the year ended December 31, 2004 increased to $7,210,000 as compared to $6,344,000 for 2003. Other than legal costs as described below, this increase was mainly attributable to a higher level of general corporate expenses to support our expanding business, including an increase in audit and consulting fees primarily related to Sarbanes Oxley compliance work of $285,000, an increase in personnel related costs of $335,000, and an increase in general corporate expenses of $354,000. General and administrative costs also included legal expenses incurred in 2004 of $3,144,000 and $3,253,000 in 2003, due primarily to the PhotoCure patent litigation costs in Australia. Total patent defense costs in 2004 were $2,150,000 as compared to $2,447,000 in 2003. OTHER INCOME, NET -- Other income for the year ended December 31, 2004, decreased to $1,580,000, as compared to $1,926,000 in 2003. This decrease reflects a reduction in our average investable cash balances during early 2004 as we used cash to support our operating activities, offset by the additional proceeds received from the private placement in March 2004. Additionally, interest income had been negatively impacted by the general decrease in interest rates which occurred during 2003 and early 2004. During 2004 and 2003, we incurred interest expense of $20,000 and $56,000, respectively, on borrowings associated with the construction of our Kerastick(R) manufacturing facility. Of these amounts, 56 $36,000 was capitalized in property and equipment in the Consolidated Balance Sheet in 2003. We repaid the outstanding secured term loan promissory note with Citizens Bank of Massachusetts in June 2004. INCOME TAXES -- There was no provision for income taxes due to ongoing operating losses. As of December 31, 2004, we had net operating loss carryforwards of approximately $74,243,000 and tax credit carryforwards of approximately $2,278,000 for Federal reporting purposes. These amounts expire at various times through 2024. See Note 8 to the Notes to the Consolidated Financial Statements. We have provided a full valuation allowance against the net deferred tax assets at December 31, 2004 and 2003. NET LOSS -- For the year ended December 31, 2004, we recognized a net loss of $15,629,000, or $0.96 per share, as compared to $14,827,000, or $1.06 per share, for the year ended 2003. The decrease in net loss per share in 2004 as compared to 2003 was primarily due to an increase in the number of weighted average of common shares outstanding during 2004 as a result of our private placement earlier in 2004. The increase in total net loss in 2004 was due to the increase in operating costs offset, in part, by an increase in revenues. Net losses are expected to continue until product sales to physicians offset the cost of our sales force and marketing initiatives, and the costs for other business support functions. 57 QUARTERLY RESULTS OF OPERATIONS The following is a summary of the unaudited quarterly results of operations for the years ended December 31, 2005 and 2004, respectively:
QUARTERLY RESULTS FOR YEAR ENDED DECEMBER 31, 2005 -------------------------------------------------------------- MARCH 31 JUNE 30 SEPTEMBER 30 DECEMBER 31 ---------- ---------- ------------ ----------- Total revenues $3,368,614 $2,228,116 $2,392,244 $3,348,487 Loss from operations (4,698,611) (5,178,714) (3,948,670) (2,560,692) Net loss (4,331,614) (4,826,118) (3,608,281) (2,232,696) Basic and diluted loss per share $ (0.26) $ (0.29) $ (0.21) $ (0.13)
QUARTERLY RESULTS FOR YEAR ENDED DECEMBER 31, 2004 -------------------------------------------------------------- MARCH JUNE 31 30 SEPTEMBER 30 DECEMBER 31 ---------- ---------- ------------ ----------- Total revenues $1,255,685 $2,176,028 $2,010,619 $2,545,324 Loss from operations (4,800,791) (4,571,668) (3,325,565) (4,510,703) Net loss (4,401,654) (4,196,087) (2,974,992) (4,056,247) Basic and diluted loss per share (0.30) (0.25) (0.18) (0.24)
LIQUIDITY AND CAPITAL RESOURCES We remain in a strong cash position to continue to fund increased Levulan(R) PDT sales and marketing expenses and current research and development activities for our Levulan(R) PDT/PD platform. At February 28, 2006, we had approximately $31,147,000 of total cash resources comprised of $11,681,000 of cash and cash equivalents, $19,466,000 of marketable securities. The Company is also exposed to concentration of credit risk related to accounts receivable that are generated from its distributors and customers. To manage credit risk, the Company performs regular credit evaluations of its customers' and provides allowances for potential credit losses, when applicable. On December 30, 2005, we signed a definitive Merger Agreement to acquire all of the common stock of Sirius Laboratories Inc. of Vernon Hills, Illinois in exchange for cash and common stock worth up to $30,000,000. Sirius is a privately held dermatology specialty pharmaceuticals company founded in 2000 with a primary focus on the treatment of acne vulgaris and acne rosacea. Closing of the transaction is expected in the first quarter of 2006, subject to the terms and conditions in the Merger Agreement. Of the up to $30,000,000, $8,000,000 less certain expenses will be paid in cash upon closing, $17,000,000 will be paid in shares of DUSA's common stock also upon closing in a private placement, and up to $5,000,000 in cash or common stock may be paid based on a combination of new product approvals or launches, and achievement of certain pre-determined total cumulative sales milestones for Sirius products. As part of the Sirius Merger, we also expect to pay at closing certain expenses incurred by Sirius related to the acquisition and Sirius' balance on their bank line of credit, if any. We believe we have sufficient resources to finance the acquisition utilizing our existing resources. On February 27, 2004, we consummated a private placement of 2,250,000 shares of our common stock at a purchase price of $11.00 per share resulting in gross proceeds of $24,750,000. We also granted the investors the right to purchase up to an aggregate of an additional 337,500 shares of common stock at $11.00 per share, which were exercised on April 14, 2004, resulting in additional proceeds of $3,712,500. 58 Offering costs incurred in connection with the placement were $1,908,000, of which $1,708,000 consisted of the placement agent's commission and non-refundable retainer paid in the form of 155,250 shares of common stock calculated at the offering price. As of December 31, 2005, our working capital (total current assets minus total current liabilities) was $34,889,000 as compared to $48,799,000 as of December 31, 2004. Total current assets decreased $13,766,000 in 2005 due primarily to a decrease in marketable securities, which was used to fund our loss from operations. Total current liabilities increased $143,000 in 2005 due to an increase in accounts payable and other accrued expenses, partially offset by a decrease in deferred revenue. During 2005, we used $14,101,000 of cash to support our operating activities, purchased $415,000 of property, plant, and equipment, received $928,000 in exercises of stock options and received $14,874,000 of net proceeds from maturations and sales of marketable securities. During the comparable 2004 period, we used $14,070,000 of cash for operating activities, purchased $530,000 of property, plant and equipment, received $765,000 n proceeds from exercises of stock options and invested $14,037,000 of net proceeds from maturations and sales of marketable securities. We believe that we have sufficient capital resources to proceed with our current programs for Levulan(R) PDT, and to fund operations and capital expenditures for approximately 2 years. We have invested our funds in liquid investments, so that we have ready access to these cash reserves for funding our needs on a short-term and long-term basis. However, upon the closing of the Sirius Merger we will deplete a significant amount of our liquid assets and if product revenues do not meet our expectations, we will need to raise capital in order to continue our research and development activities as planned. In addition to the contemplated merger with Sirius Laboratories, Inc., we continue to seek opportunities to enhance our business by using resources to acquire by license, purchase or other arrangements, businesses, new technologies, or products, especially in dermatology-related areas in the near term. For 2006, we are focusing primarily on increasing the sales of our approved products in the U.S. and Canada, continuing our efforts of exploring partnership opportunities for Levulan(R) PDT for dermatology in Europe and/or other countries outside of the United States, Canada and Latin America, and continuing our clinical development programs for our facial photodamage and moderate to severe acne indications. In January 2006, we entered into a marketing and distribution agreement with Stiefel Laboratories, Inc. granting Stiefel an exclusive right to distribute the Levulan(R) Kerastick(R) in Mexico, Central and South America. We have also signed clinical trial agreements with the National Cancer Institute, or NCI, Division of Cancer Prevention, or DCP, for the clinical development of Levulan(R) PDT for the treatment of high-grade dysplasia, or HGD, within Barrett's Esophagus, or BE, and oral cavity dysplasia treatment, and are working with the NCI DCP to advance the development of these programs. In addition, we continue to support independent investigator trials to advance research in the use and applicability of Levulan(R) PDT for other indications in dermatology, and selected internal indications. We and the NCI DCP have prepared outlines of clinical studies in both indications. The NCI DCP is currently working with us and investigators to finalize the clinical trial designs. The NCI DCP will use its resources to file its own Investigational New Drug applications with the FDA. Our costs related to these studies will be limited to providing Levulan(R), device(s) and the necessary training for the investigators involved. All other costs of these studies will be the responsibility of the NCI DCP. Full development and testing of the use of Levulan PDT for treatment of acne and facial photodamage would require additional funding. The timing of expenditures will be dependent on various factors, including: 59 - the level of sales of our products including the success of our marketing programs for the dermatological uses of Levulan(R) PDT, - progress of our research and development programs, - the results of preclinical and clinical trials, - the timing of regulatory marketing approvals, - competitive developments, - the results of patent disputes, - any new additional collaborative arrangements, if any, we may enter, and - the availability of other financing. At this time, we cannot accurately predict the level of revenues from sales of our products. In order to maintain and continue to expand our sales and marketing endeavors, and to initiate our planned research and development programs, we may need to raise additional funds through future corporate alliances, financings, or other sources, depending upon the amount of sales we generate. DUSA has no off-sheet balance sheet financing arrangements other than its operating leases. CONTRACTUAL OBLIGATIONS AND OTHER COMMERCIAL COMMITMENTS Our contractual obligations and other commercial commitments to make future payments under contracts, including lease agreements, research and development contracts, manufacturing contracts, or other related agreements, are as follows at December 31, 2005:
OBLIGATIONS DUE BY PERIOD --------------------------------------------------------------- 1 YEAR OR AFTER 5 TOTAL LESS 2-3 YEARS 4-5 YEARS YEARS ---------- ---------- --------- --------- --------- Operating lease obligations $2,959,000 $ 470,000 $ 887,000 $ 880,000 $722,000 Purchase obligations (1, 2) $1,934,000 $1,934,000 - - - Minimum royalty obligations (3) $667,000 $ 86,000 $ 172,000 $ 172,000 $237,000
- ---------- 1) Research and development projects include various commitments including obligations for our Phase II clinical studies for photodamaged skin and moderate to severe acne. 2) In addition to the obligations disclosed above, we have contracted with Therapeutics, Inc., a clinical research organization, to manage the clinical development of our products in the field of dermatology. This organization has the opportunity for additional stock grants, bonuses, and other incentives for each product indication ranging from $250,000 to $1,250,000, depending on the regulatory phase of development of products under Therapeutics' management. 3) Annual minimum royalties to PARTEQ must total at least CDN $100,000 (U.S. $86,000 as of December 31, 2005) through the expiration of the term of the agreement. RECENTLY ISSUED ACCOUNTING GUIDANCE 60 In November 2004, the FASB issued SFAS No. 151, "Inventory Costs, an amendment of ARB No. 43, Chapter 4." The amendments made by SFAS No. 151 clarify that abnormal amounts of idle facility expense, freight, handling costs, and wasted materials should be recognized as current-period charges and require the allocation of fixed production overheads to inventory based on the normal capacity of the production facilities. The provisions of SFAS No. 151 are effective for inventory costs incurred during fiscal years beginning after June 15, 2005. We have adopted this standard beginning the first quarter of 2006 and do not believe the adoption will have a material impact on our results of operations or financial position as such costs have historically been expensed as incurred. In November 2005, FASB issued FASB Staff Position FAS 115-1 and FAS 124-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments" ("FSP FAS 115-1"), which provides guidance on determining when investments in certain debt and equity securities are considered impaired, whether that impairment is other-than-temporary, and on measuring such impairment loss. FSP FAS 115-1 also includes accounting considerations subsequent to the recognition of an other-than-temporary impairment and requires certain disclosures about unrealized losses that have not been recognized as other-than-temporary impairments. FSP FAS 115-1 is required to be applied to reporting periods beginning after December 15, 2005. We are required to adopt FSP FAS 115-1 in the first quarter of 2006. We do not expect that the adoption of this statement will have a material impact on our results of operations or financial condition. The unrealized losses on the Company's investments in U.S. Treasury obligations, and direct obligations of U.S. government agencies and investment grade corporate securities were caused by interest rate increases. It is expected that these securities would not be settled at a price less than the amortized cost of the Company's investment. Because the Company has the ability and 61 intent to hold these investments until a recovery of fair value, which may be maturity, the Company does not consider these investments to be other-than-temporarily impaired at December 31, 2005. INFLATION Although inflation rates have been comparatively low in recent years, inflation is expected to apply upward pressure on our operating costs. We have included an inflation factor in our cost estimates. However, the overall net effect of inflation on our operations is expected to be minimal. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Our exposure to market risk for changes in interest rates relates primarily to our investment portfolio. We do not use derivative financial instruments in our investment portfolio. Our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment. Our investments consist of United States government securities and high grade corporate bonds. All investments are carried at market value, which approximates cost. As of December 31, 2005, the weighted average rate of return on our investments was 4.08%. If market interest rates were to increase immediately and uniformly by 100 basis points from levels as of December 31, 2005, the fair market value of the portfolio would decline by $259,000. Declines in interest rates could, over time, reduce our interest income. FORWARD-LOOKING STATEMENTS SAFE HARBOR This report, including the Management's Discussion and Analysis, contains various "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and 21E of the Securities Exchange Act of 1934 which represent our expectations or beliefs concerning future events, including, but not limited to management's goal of becoming profitable, statements regarding our strategies and core objectives for 2006, our expectations regarding our proposed merger with Sirius Laboratories, Inc. and matters relating thereto, management's beliefs regarding the unique nature of Levulan(R) and its use and potential use, expectations regarding the timing of results of clinical trials, future development of Levulan(R) and our other products for cancer, warts, onychomycosis, psoriasis, molluscum contagiosum, oily skin and acne rosacea, facial photodamaged skin, cystic acne, acne vulgaris, Barrett's esophagus, high-grade dysplasia, infected sweat glands (hidradenitis suppurativa) and other potential indications, intention to pursue licensing, marketing, co-promotion, collaboration or acquisition opportunities, status of clinical programs for all other indications and beliefs regarding potential efficacy and marketing, our intention to develop combination drug and light device systems, our expectations regarding new proprietary endoscopic light delivery systems and the potential use of other light devices, our beliefs regarding the safety, simplicity, reliability and cost-effectiveness of certain light sources, our expectations regarding product launches, our intention to expand our sales force, hope that our products will be an AK therapy of choice and barriers to achieving that status, our beliefs regarding revenues and market opportunities from approved and potential products and Levulan's(R) competitive properties, our intention to postpone or commence clinical trials and investigator studies in 2006, beliefs regarding the clinical benefit of Levulan(R) PDT for acne and other indications, beliefs regarding the suitability of clinical data, expectations of exclusivity under the Hatch-Waxman Act and other patent laws and the potential benefits thereof, expectations regarding the confidentiality of our proprietary information, intentions to seek additional U.S. and foreign regulatory approvals, trademarks, and to 62 market and increase sales outside the U.S., beliefs regarding regulatory classifications, filings, timelines, off-label use and environmental compliance, beliefs concerning patent disputes and litigation, the impact of a third-party's regulatory compliance and fulfillment of contractual obligations, expectations of increases in cost of product sales, expectations regarding margins on Kerastick(R) and other products, estimations as to the time it takes for a sales representative to break even in comparison to DUSA's investment, expected use of cash resources in 2006, requirements of cash resources for our future liquidity, beliefs regarding investments and economic conditions, beliefs regarding accounting policies and practices, expectations regarding outstanding options and warrants and our dividend policy, anticipation of increases or decreases in personnel, effect of reimbursement policies on revenues and acceptance of our therapies, expectations for future strategic opportunities and research and development programs, expectations for continuing operating losses and competition, expectations regarding the adequacy and availability of insurance, expectations regarding stable general and administrative costs, expectations regarding the status of research and development costs and our efforts with respect thereto, expectations regarding increased sales and marketing costs, levels of interest income and our capital resource needs, intention to sell securities to meet capital requirements, potential for additional inspection and testing of our manufacturing facilities, beliefs regarding the adequacy of our inventory of Kerastick(R) and BLU-U(R) units, our manufacturing capabilities and the impact of inventories on revenues, belief regarding interest rate risks to our investments and effects of inflation and new and existing accounting standards and policies, beliefs regarding the impact of any current or future legal proceedings, dependence on key personnel, beliefs concerning product liability insurance, intention to continue to develop an alternative BLU-U(R) light device and integrated drug and light device systems, our principal methods of competition, competition in general and competitive developments. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, changing market and regulatory conditions, actual clinical results of our trials, the reimbursement by third-parties for our treatments, the impact of competitive products and pricing, the timely development, FDA and foreign regulatory approval, and market acceptance of our products, environmental risks relating to our products, reliance on third-parties for the production, manufacture, sales and marketing of our products, the availability of products for acquisition and/or license on terms agreeable to DUSA, sufficient sources of funds, the securities regulatory process, the maintenance of our patent portfolio and ability to obtain competitive levels of reimbursement by third-party payors, none of which can be assured. Results actually achieved may differ materially from expected results included in these statements as a result of these or other factors. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Report of Independent Registered Public Accounting Firm......... F-1 Consolidated Balance Sheets..................................... F-2 Consolidated Statements of Operations........................... F-3 Consolidated Statements of Shareholders' Equity................. F-4 Consolidated Statements of Cash Flows........................... F-5 Notes to the Consolidated Financial Statements.................. F-6 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 63 ITEM 9A. CONTROLS AND PROCEDURES Evaluation of Disclosure Controls and Procedures. We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-14. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective in timely alerting them to material information relating to our (including our subsidiaries) required to be included in our periodic Securities and Exchange Commission filings. No significant changes were made in our internal controls or in other factors that could significantly affect these controls subsequent to the date of their evaluation. Changes in Internal Control Over Financial Reporting. There was no change in our internal control over financial reporting that occurred during the period covered by this Report that has materially affected, or is reasonably likely to materially affect, our internal control over-financial reporting. MANAGEMENT'S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework in Internal Control -- Integrated Framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2005. Our management's assessment of the effectiveness of our internal control over financial reporting as of December 31, 2005 has been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their report which is included herein. 64 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of DUSA Pharmaceuticals, Inc. Wilmington, Massachusetts We have audited management's assessment, included in the accompanying Management's Report on Internal Control over Financial Reporting that DUSA Pharmaceuticals, Inc. and its subsidiary (the "Company") maintained effective internal control over financial reporting as of December 31, 2005, based on criteria established in Internal Control--Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company's management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting. Our responsibility is to express an opinion on management's assessment and an opinion on the effectiveness of the Company's internal control over financial reporting based on our audit. We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, evaluating management's assessment, testing and evaluating the design and operating effectiveness of internal control, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinions. A company's internal control over financial reporting is a process designed by, or under the supervision of, the company's principal executive and principal financial officers, or persons performing similar functions, and effected by the company's board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements. Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. In our opinion, management's assessment that the Company maintained effective internal control over financial reporting as of December 31, 2005, is fairly stated, in all material respects, based on the criteria established in Internal Control--Integrated Framework issued by the Committee of Sponsoring 65 Organizations of the Treadway Commission. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2005, based on the criteria established in Internal Control--Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements as of and for the year ended December 31, 2005, of the Company and our report dated March 10, 2006, expressed an unqualified opinion on those financial statements. /s/ DELOITTE & TOUCHE LLP Boston, Massachusetts March 10, 2006 66 ITEM 9B. OTHER INFORMATION None. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The information required by Item 10 is hereby incorporated by reference to the sections entitled "Nominees," "Executive Officers who are not Directors," and "Compliance with Section 16(a) of the Exchange Act" of the Registrant's 2006 Proxy Statement. ITEM 11. EXECUTIVE COMPENSATION The information required by Item 11 is hereby incorporated by reference to the sections entitled "Director Compensation," "Executive Compensation," "Board Compensation Committee Report on Executive Compensation," "Performance Graph," "Option Grants in 2005," "Aggregate Option Exercises in 2006 and Option Values at December 31, 2005," and "Other Compensation" of Registrant's 2006 Proxy Statement. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS The information required by Item 12 is hereby incorporated by reference to the section entitled "Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters" of the Registrant's 2006 Proxy Statement. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by Item 13 is hereby incorporated by reference to the section entitled "Certain Relationships and Related Transactions" of the Registrant's 2006 Proxy Statement. ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES The information required by Item 14 is hereby incorporated by reference to the section entitled "Ratification and Selection of Auditors" of the Registrant's 2006 Proxy Statement. 67 ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES A. List of Financial Statements and Schedules Report of Independent Registered Public Accounting Firm..... F-1 Consolidated Balance Sheets................................. F-2 Consolidated Statements of Operations....................... F-3 Consolidated Statements of Shareholders' Equity............. F-4 Consolidated Statements of Cash Flows....................... F-5 Notes to the Consolidated Financial Statements.............. F-6 B. Exhibits filed as part of this Report 2(a.1)* Merger Agreement by and among the Company, Sirius Laboratories, Inc., and the shareholders of Sirius dated as of December 30, 2005; and 2(a.2) First Amendment to Merger Agreement by and among the Company, Sirius Laboratories, Inc. and the shareholders of Sirius, dated as of February 6, 2006. 3(a.1) Certificate of Incorporation, as amended, filed as Exhibit 3(a) to the Registrant's Form 10-K for the fiscal year ended December 31, 1998, and is incorporated herein by reference; 3(a.2) Certificate of Amendment to the Certificate of Incorporation, as amended, dated October 28, 2002 and filed as Exhibit 99.3 to the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2002, filed November 12, 2002 and is incorporated herein by reference; and 3(b) By-laws of the Registrant, filed as Exhibit 3 to the Registrant's current report on Form 8-K, filed on January 4, 2005, and is incorporated herein by reference. 4(a) Common Stock specimen, filed as Exhibit 4(a) to the Registrant's Form 10-K for the fiscal year ended December 31, 2002, and is incorporated herein by reference; 4(b) Class B Warrant, filed as Exhibit 4.3 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; 4(c) Rights Agreement filed as Exhibit 4.0 to Registrant's Current Report on Form 8-K dated September 27, 2002, filed October 11, 2002, and is incorporated herein by reference; and 4(d) Rights Certificate relating to the rights granted to holders of common stock under the Rights Agreement filed as Exhibit 4.0 to Registrant's Current Report on Form 8-K, dated September 27, 2002, filed October 11, 2002, and is incorporated herein by reference. 10(a) License Agreement between the Company, PARTEQ and Draxis Health Inc. dated August 27, 1991, filed as Exhibit 10.1 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; 10(b) ALA Assignment Agreement between the Company, PARTEQ, and Draxis Health Inc. dated October 7, 1991, filed as Exhibit 10.2 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; 10(b.1) Amended and Restated Assignment Agreement between the Company and Draxis Health, Inc. dated April 16, 1999, filed as Exhibit 10(b.1) to the Registrant's Form 10-K for the fiscal year ended December 31, 1999, and is incorporated herein by reference; 68 10(b.2) Termination and Transfer Agreement between the Company and Draxis Health Inc. dated as of February 24, 2004, filed as Exhibit 10(b.2) to the Registrant's Form 10-K for the fiscal year ended December 31, 2003, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(c) Employment Agreement of D. Geoffrey Shulman, MD, FRCPC dated October 1, 1991, filed as Exhibit 10.4 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; + 10(d) Amendment to Employment Agreement of D. Geoffrey Shulman, MD, FRCPC dated April 14, 1994, filed as Exhibit 10.4 to the Registrant's Registration Statement on Form S-2, No. 33-98030, and is incorporated herein by reference; + 10(e) Amended and Restated License Agreement between the Company and PARTEQ dated March 11, 1998, filed as Exhibit 10(e) to the Registrant's Form 10-K/A filed on June 18, 1999, portions of Exhibit A have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(f) Incentive Stock Option Plan, filed as Exhibit 10.11 of Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; + 10(g) 1994 Restricted Stock Option Plan, filed as Exhibit 1 to Registrant's Schedule 14A definitive Proxy Statement dated April 26, 1995, and is incorporated herein by reference; + 10(h) 1996 Omnibus Plan, as amended, filed as Appendix A to Registrant's Schedule 14A Definitive Proxy Statement dated April 26, 2001, and is incorporated herein by reference; + 10(h.1) 1996 Omnibus Plan, as amended on May 1, 2003, filed as Exhibit 10(h.1) to the Registrant's Form 10-K for the fiscal year ended December 31, 2003, and is incorporated herein by reference; + 10(h.2) 1996 Omnibus Plan, as amended April 23, 2004, filed as Appendix A to Registrant's Schedule 14A definitive Proxy Statement dated April 28, 2004, and is incorporated herein by reference; + 10(i) Purchase and Supply Agreement between the Company and National Biological Corporation dated November 5, 1998, filed as Exhibit 10(i) to the Registrant's Form 10-K/A filed on June 18, 1999, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(i.1) Amended and Restated Purchase and Supply Agreement between the Company and National Biological Corporation dated as of June 21, 2004 filed as Exhibit 10(a) to the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2004, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, filed August 11, 2004, and is incorporated herein by reference; 10(j) Supply Agreement between the Company and Sochinaz SA dated December 24, 1993, filed as Exhibit 10(q) to Registrant's Form 10-K/A filed on March 21, 2000, portions of which have been 69 omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(j.1) First Amendment to Supply Agreement between the Company and Sochinaz SA dated July 7, 1994, filed as Exhibit 10(q.1) to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1999, and is incorporated herein by reference; 10(j.2) Second Amendment to Supply Agreement between the Company and Sochinaz SA dated as of June 20, 2000, filed as Exhibit 10.1 to Registrant's Current Report on Form 8-K dated June 28, 2000, and is incorporated herein by reference; 10(j.3) Third Amendment to Supply Agreement between the Company and Sochinaz SA dated July 29, 2005, filed as Exhibit 10.1 to the Registrant's Form 10-Q filed on August 3, 2005, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(k) Master Service Agreement between the Company and Therapeutics, Inc. dated as of October 4, 2001, filed as Exhibit 10(b) to the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2001, filed November 8, 2001, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended and is incorporated herein by reference; 10(l) License and Development Agreement between the Company and photonamic GmbH & Co. KG dated as of December 30, 2002, filed as Exhibit 10(r) to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2002, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b)-2 of the Securities Exchange Act of 1934, as amended and is incorporated herein by reference; 10(m) Supply Agreement between the Company and medac GmbH dated as of December 30, 2002, filed as Exhibit 10(r) to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2002, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b)-2 of the Securities Exchange Act of 1934, as amended and is incorporated herein by reference; 10(n) Securities Purchase Agreement dated as of February 27, 2004, by and among the Company and certain investors, filed as Exhibit 10.1 to the Registrant's current report on Form 8-K, filed on March 2, 2004, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b) of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(o) Registration Rights Agreement dated as of February 27, 2004 by and among the Company and certain investors, filed as Exhibit 10.2 to the Registrant's current report on Form 8-K, filed on March 2, 2004, and is incorporated herein by reference; 10(p) Form of Additional Investment Right dated as of February 27, 2004, filed as Exhibit 10.3 to the Registrant's current report on Form 8-K, filed on March 2, 2004, and is incorporated herein by reference; 10(q) License, Promotion, Distribution and Supply Agreement between the Company and Coherent-AMT dated as of March 31, 2004 filed as Exhibit 10(a) to the Registrant's Quarterly Report on 70 Form 10-Q for the fiscal quarter ended March 31, 2004, filed May 4, 2004, and is incorporated herein by reference; 10(r) Employment Agreement of Scott L. Lundahl dated as of June 23, 1999 filed as Exhibit 10(u) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(s) Amended Employment Agreement of Stuart L. Marcus, MD, PhD dated December 9, 1999 filed as Exhibit 10(v) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(t) Employment Agreement of Mark C. Carota dated as of February 14, 2000 filed as Exhibit 10(w.1) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(t.1) First Amendment to Employment Agreement of Mark C. Carota dated October 31, 2001 filed as Exhibit 10(w.2) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(u) Employment Agreement of Paul A. Sowyrda dated as of July 31, 2001 filed as Exhibit 10(x) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(v) Employment Agreement of Richard Christopher dated as of January 1, 2004 filed as Exhibit 10(y) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(w) Employment Agreement of Robert F. Doman dated as of March 15, 2005 filed as Exhibit 10(z) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(x) Employment Agreement of Gary F. Talarico dated as of February 15, 2005 filed as Exhibit 10(aa) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(y) Severance Agreement and General Release between the Company and Peter Chakoutis dated as of February 25, 2005 filed as Exhibit 10(bb) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(y.1) Final Agreement and General Release, between the Company and Peter Chakoutis, dated as of April 4, 2005, filed as Exhibit 10.1 to the Registrant's Current Report on Form 8-K, filed on April 4, 2005, and is incorporated herein by reference; + 10(z) Compensation Policy Applicable to the Company's Non-Employee Directors filed as Exhibit 10(cc) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; and + 10(aa) Marketing, Distribution and Supply Agreement between the Company and Stiefel Laboratories, Inc., dated as of January 12, 2006, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b)-2 of the Securities Exchange Act of 1934, as amended. 14(a) Form of DUSA Pharmaceuticals, Inc. Code of Ethics Applicable to Senior Officers, filed as Exhibit 14(a) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference. 21(a) Subsidiaries of the Registrant. 23(a) Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm. 31(a) Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer; and 31(b) Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer. 32(a) Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002; and 32(b) Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. + Management contract or compensatory plan or arrangement. 71 * Schedules and exhibits omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the Commission upon request. 72 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of DUSA Pharmaceuticals, Inc. Wilmington, Massachusetts We have audited the accompanying consolidated balance sheets of DUSA Pharmaceuticals, Inc. and its subsidiary (the "Company") as of December 31, 2005 and 2004, and the related consolidated statements of operations, shareholders' equity, and cash flows for each of the three years in the period ended December 31, 2005. 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 the standards of the Public Company Accounting Oversight Board (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, such consolidated financial statements present fairly, in all material respects, the financial position of Dusa Pharmaceuticals, Inc. and subsidiaries as of December 31, 2005 and 2004, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2005, in conformity with accounting principles generally accepted in the United States of America. We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the effectiveness of the Company's internal control over financial reporting as of December 31, 2005, based on the criteria established in Internal Control--Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 10, 2006, expressed an unqualified opinion on management's assessment of the effectiveness of the Company's internal control over financial reporting and an unqualified opinion on the effectiveness of the Company's internal control over financial reporting. /s/ DELOITTE & TOUCHE LLP Boston, Massachusetts March 10, 2006 F-1 DUSA PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS
DECEMBER 31, ------------------------- 2005 2004 ----------- ----------- ASSETS CURRENT ASSETS Cash and cash equivalents $ 4,210,675 $ 2,928,143 Marketable securities 30,579,486 46,222,969 Accrued interest receivable 353,449 641,797 Accounts receivable, net 373,130 711,016 Inventory 1,860,793 1,417,160 Deferred acquisition costs 831,875 -- Prepaids and other current assets 776,293 830,895 ----------- ----------- TOTAL CURRENT ASSETS 38,985,701 52,751,980 Restricted cash 144,541 140,764 Property, plant and equipment, net 2,971,869 3,481,888 Deferred charges and other assets 228,520 276,256 ----------- ----------- TOTAL ASSETS $42,330,631 $56,650,888 =========== =========== LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES Accounts payable $ 934,694 $ 857,268 Accrued compensation 1,071,677 963,607 Other accrued expenses 1,995,679 1,901,841 Deferred revenue 94,283 230,715 ----------- ----------- TOTAL CURRENT LIABILITIES 4,096,333 3,953,431 Other liabilities 205,570 190,439 ----------- ----------- TOTAL LIABILITIES 4,301,903 4,143,870 =========== =========== COMMITMENTS AND CONTINGENCIES (NOTE 12) SHAREHOLDERS' EQUITY Capital Stock Authorized: 100,000,000 shares; 40,000,000 shares designated as common stock, no par, 60,000,000 shares issuable in series or classes; and 40,000 junior Series A preferred shares. Common stock shares issued and outstanding: 17,041,197 in 2005 and 16,876,822 in 2004, no par 125,626,163 124,698,059 Additional paid-in capital 2,035,783 2,016,339 Accumulated deficit (89,537,470) (74,538,761) Accumulated other comprehensive (loss) income (95,748) 331,381 ----------- ----------- TOTAL SHAREHOLDERS' EQUITY 38,028,728 52,507,018 ----------- ----------- TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $42,330,631 $56,650,888 =========== ===========
See the accompanying Notes to the Consolidated Financial Statements. F-2 DUSA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS
YEAR ENDED DECEMBER 31, ----------------------------------------------- 2005 2004 2003 -------------- ------------- ------------ REVENUES Kerastick(R) Product Revenues $ 8,891,565 $ 5,850,835 $ 900,803 BLU-U(R) Product Revenues 2,445,896 2,136,821 69,306 -------------- ------------- ------------ PRODUCT REVENUES 11,337,461 7,987,656 970,109 COST OF PRODUCT REVENUES Kerastick(R) Cost of Product Revenues and Royalties 3,583,650 2,023,685 2,261,749 BLU-U(R) Cost of Product Revenues 2,629,951 1,851,333 1,219,499 -------------- ------------- ------------ COST OF PRODUCT REVENUES AND ROYALTIES 6,213,601 3,875,018 3,481,248 GROSS MARGIN 5,123,860 4,112,638 (2,511,139) OPERATING COSTS Research and Development 5,587,599 6,489,723 5,403,961 Marketing and sales 9,068,984 7,622,106 2,494,405 General and administrative 6,703,047 7,209,536 6,343,680 Restructuring 150,917 - - -------------- ------------- ------------ TOTAL OPERATING COSTS 21,510,547 21,321,365 14,242,046 -------------- ------------- ------------ LOSS FROM OPERATIONS (16,386,687) (17,208,727) (16,753,185) -------------- ------------- ------------ OTHER INCOME Interest income 1,387,978 1,579,747 1,926,331 -------------- ------------- ------------ NET LOSS $ (14,998,709) $ (15,628,980) $(14,826,854) ============== ============= ============ BASIC AND DILUTED NET LOSS PER COMMON SHARE $ (0.89) $ (0.96) $ (1.06) ============== ============= ============ WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 16,932,138 16,317,078 13,936,482 ============== ============= ============
See the accompanying Notes to the Consolidated Financial Statements. F-3 DUSA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
COMMON STOCK -------------------------- ACCUMULATED ADDITIONAL OTHER NUMBER OF PAID-IN ACCUMULATED COMPREHENSIVE SHARES AMOUNT CAPITAL DEFICIT INCOME (LOSS) TOTAL ---------- ------------- ----------- -------------- ------------- ------------- BALANCE, JANUARY 1, 2003 13,887,612 $ 95,490,561 $ 2,015,586 $ (44,082,927) $ 2,634,510 $ 56,057,730 ---------- ------------- ----------- -------------- ------------- ------------- Comprehensive loss: Net loss for period (14,826,854) (14,826,854) Net unrealized loss on marketable securities available for sale (1,178,820) (1,178,820) ------------- Total comprehensive loss (16,005,674) Issuance of common stock to consultants 44,416 110,000 110,000 Exercises of options 11,000 32,870 32,870 Issuance of common stock to employee 23,219 37,123 37,123 ---------- ------------- ----------- -------------- ------------- ------------- BALANCE, DECEMBER 31, 2003 13,966,247 $ 95,670,554 $ 2,015,586 $ (58,909,781) $ 1,455,690 $ 40,232,049 ---------- ------------- ----------- -------------- ------------- ------------- Comprehensive loss: Net loss for period (15,628,980) (15,628,980) Net unrealized loss on marketable (1,124,309) (1,124,309) securities available for sale ------------- Total comprehensive loss (16,753,289) Issuance of common stock for cash through a private placement, net of total offering costs of $1,907,952 including 155,250 shares issued to placement agent 2,742,750 28,262,298 28,262,298 Exercises of options 167,825 765,207 765,207 Issuance of options to consultants 240,753 240,753 Repurchase of options issued to consultants (240,000) (240,000) ---------- ------------- ----------- -------------- ------------- ------------- BALANCE, DECEMBER 31, 2004 16,876,822 124,698,059 2,016,339 (74,538,761) 331,381 52,507,018 Comprehensive loss Net loss for period (14,998,709) (14,998,709) Net unrealized loss on marketable (427,129) (427,129) securities available for sale ------------- Total comprehensive loss (15,425,838) Exercises of options 164,375 928,104 928,104 Acceleration of vesting of stock options 19,444 19,444 ---------- ------------- ----------- -------------- ------------- ------------- BALANCE, DECEMBER 31, 2005 17,041,197 $ 125,626,163 $ 2,035,783 $ (89,537,470) $ (95,748) $ 38,028,728 ========== ============= =========== ============== ============= =============
See the accompanying Notes to the Consolidated Financial Statements. F-4 DUSA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS
YEAR ENDED DECEMBER 31, --------------------------------------------- 2005 2004 2003 ------------- ------------ ------------ CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES Net (loss) $ (14,998,709) $(15,628,980) $(14,826,854) Adjustments to reconcile net loss to net cash used in operating activities: Amortization of premiums and accretion of discounts on debt securities, net 416,550 225,614 100,346 Realized gain on sale of marketable securities (74,512) - - Depreciation and amortization 925,185 1,299,308 1,610,848 Stock-based compensation 19,444 240,753 110,000 Changes in other assets and liabilities impacting cash flows from operating activities: Accrued interest receivable 288,348 (108,001) 165,868 Accounts receivable 337,886 (481,533) (192,763) Inventory (443,632) (704,329) 475,828 Prepaid and other current assets (729,537) 169,518 (84,709) Deferred charges and other assets - (276,256) - Accounts payable 77,426 (2,014) 306,391 Accrued compensation and other accrued expenses 201,907 906,691 (550,872) Deferred revenue (136,432) 100,815 124,800 Other liabilities-non current 15,131 190,439 - ------------- ------------ ------------ NET CASH USED IN OPERATING ACTIVITIES (14,100,945) (14,067,975) (12,761,117) ------------- ------------ ------------ CASH FLOWS PROVIDED BY (USED IN) INVESTING ACTIVITIES Purchases of marketable securities (58,850,356) (58,858,323) (4,000,000) Proceeds from maturities and sales of marketable securities 73,724,674 44,821,212 15,000,000 Restricted cash (3,777) (1,551) (1,330) Purchases of property, plant and equipment (415,168) (529,707) (632,654) Repurchase of options issued to consultants - (240,000) - ------------- ------------ ------------ NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES 14,455,373 (14,808,369) 10,366,016 ------------- ------------ ------------ CASH FLOWS PROVIDED BY (USED IN) FINANCING ACTIVITIES Issuance of common stock (net of stock offering costs of $200,202) - 28,262,298 - Payment of long-term debt - (1,517,500) (270,000) Proceeds from exercise of options 928,104 765,207 32,870 ------------- ------------ ------------ NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES 928,104 27,510,005 (237,130) ------------- ------------ ------------ NET DECREASE IN CASH AND CASH EQUIVALENTS 1,282,532 (1,366,339) (2,632,231) CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 2,928,143 4,294,482 6,926,713 ------------- ------------ ------------ CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 4,210,675 $ 2,928,143 $ 4,294,482 ============= ============ ============ Cash paid for interest $ 20,186 $ 58,623 ============= ============ ============
NON-CASH TRANSACTIONS During 2004, the Company issued 155,250 shares of its common stock in a private placement at $11.00 per share as commission and non-refundable retainer to the placement agent for a total value of $1,707,750 (See Note 10.) Also during 2004, the Company granted 30,000 fully vested options to three consultants. These options were valued at $240,753 (See Note 10.) During 2003, the Company issued 23,219 shares of restricted common stock at $1.599 per share to its Chief Executive Officer, reflecting payment of the after-tax portion of his 2002 bonus compensation (See Note 10.) See the accompanying Notes to the Consolidated Financial Statements. F-5 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 1) NATURE OF BUSINESS DUSA Pharmaceuticals, Inc. ("DUSA" or the "Company") is a pharmaceutical company engaged primarily in the research, development and marketing of a drug named 5-aminoluvulinic acid, or ALA, which is used in combination with light devices to treat or detect a variety of conditions in processes known as photodynamic therapy or photodetection. Our drug, Levulan(R) brand of aminolevulinic acid HCl, or ALA, is being used with light, for use in a broad range of medical conditions. When we use Levulan(R) and follow it with exposure to light to treat a medical condition, it is known as Levulan(R) photodynamic therapy, or Levulan(R) PDT. When we use Levulan(R) and follow it with exposure to light to detect medical conditions it is known as Levulan(R) photodetection, or Levulan(R) PD. The Company's products, the Levulan(R) Kerastick(R) 20% Topical Solution with PDT and the BLU-U(R) brand light source were launched in the United States of America, or U.S., in September 2000 for the treatment of actinic keratoses, or AKs, of the face or scalp. AKs are precancerous skin lesions caused by chronic sun exposure that can develop over time into a form of skin cancer called squamous cell carcinoma. In addition, in September 2003 we received clearance from the U.S. Food and Drug Administration, or FDA, to market the BLU-U(R) without Levulan(R) PDT for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions. 2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES a) PRINCIPLES OF CONSOLIDATION - The Company's consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, DUSA Pharmaceuticals New York, Inc. All intercompany balances and transactions have been eliminated. b) BASIS OF PRESENTATION AND USE OF ESTIMATES - These financial statements have been prepared in conformity with accounting principles generally accepted in the United States. Such principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. c) CASH AND CASH EQUIVALENTS - Cash equivalents include money market funds. All other investments are classified as marketable securities. In December 2001, the Company executed a short-term, renewable, irrevocable and unconditional letter of credit in lieu of a security deposit for the Company's Kerastick(R) manufacturing facility at its Wilmington, Massachusetts location. The cash in support of the letter of credit is held in a separate bank account and is recorded as restricted cash in the Consolidated Balance Sheets. At December 31, 2005, the amount of the letter of credit was $136,018, and the restricted cash balance was $144,541. d) MARKETABLE SECURITIES - The Company classifies all investment securities as available-for-sale and records such investments at fair market value. Unrealized gains and losses on available for sale securities are recorded as a separate component of shareholders' equity. The premiums and discounts recorded on the purchase of the debt securities are amortized into interest income over the life of the securities. As the Company's marketable securities are available to fund operations and as management expects to sell a portion of its marketable securities in the next fiscal year in order to meet its working capital requirements, all marketable securities are classified as current assets. F-6 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 e) INVENTORY - Inventory is stated at the lower of cost (first-in, first-out method) or market. Inventory identified for research and development activities is expensed in the period in which that inventory is designated for such use. BLU-U(R) commercial light sources placed in physicians' offices for an initial evaluation period are included in inventory in the accompanying Consolidated Balance Sheets until all revenue recognition criteria are met. f) DEFERRED ACQUISITION COSTS - Deferred acquisition costs are direct costs incurred by the Company through December 31, 2005, related to a pending acquisition (see Note 13). If the negotiations are unsuccessful and a determination is made that the acquisition is not likely to be consummated, the deferred acquisition costs will be expensed in the period such a determination is made. g) PROPERTY, PLANT AND EQUIPMENT - Property, plant and equipment is carried at cost less accumulated depreciation and amortization. Depreciation is computed on a straight-line basis over the estimated lives of the related assets. Leasehold improvements are amortized over the lesser of their useful lives or the lease terms. h) VALUATION OF LONG-LIVED ASSETS - The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset may not be recoverable or that the useful lives of these assets are no longer appropriate. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. When it is determined that the carrying value of a long-lived asset is not recoverable, the asset is written down to its estimated fair value on a discounted cash flow basis. i) REVENUE RECOGNITION - Revenues on product sales are recognized when persuasive evidence of an arrangement exists, the price is fixed and determinable, delivery has occurred to end-users, and there is collection is probable. Product sales made through distributors have been recorded as deferred revenue until the product is sold by the distributors to the end user. The Company has certain units held by physicians for a trial period. No revenue is recognized until the physician elects to purchase the equipment and all other revenue recognition criteria are met. j) RESEARCH AND DEVELOPMENT COSTS - Costs related to the conceptual formulation and design of products and processes are expensed as research and development costs as they are incurred. Purchased technology, including the costs of licensed technology for a particular research project that do not have alternative future uses, are expensed at the time the costs are incurred. k) MARKETING AND SALES COSTS - The Company commenced certain marketing and sales initiatives in 2003 including the launch of its direct sales force in October 2003 and related marketing and sales activities. Costs included in marketing and sales expense consist mainly of overhead expenses such as salaries and benefits for the marketing and sales staff, commissions, and related support expenses such as travel, and telephone, as well as costs related to trade shows, miscellaneous marketing and outside consultants. All such costs are expensed as incurred. l) INCOME TAXES - The Company recognizes deferred income tax assets and liabilities for the expected future tax consequences for events that have been included in the Company's financial statements or tax returns. Deferred tax assets and liabilities are based on the difference between the financial statement and tax bases of assets and liabilities using tax rates expected to be in effect in the years in which these differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be realized. F-7 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 m) BASIC AND DILUTED NET LOSS PER COMMON SHARE - Basic net loss per common share is based upon the weighted average number of shares outstanding during each period. Stock options and warrants are not included in the computation of the weighted average number of shares outstanding for dilutive net loss per common share during each of the periods presented in the Statement of Operations, as the effect would be antidilutive. For the years ended December 31, 2005, 2004, and 2003, stock options and warrants totaling approximately 3,150,000, 3,009,000, and 2,745,000 shares, respectively, have been excluded from the computation of diluted net loss per share. n) STOCK-BASED COMPENSATION - Statement of Financial Accounting Standard ("SFAS") No. 123, "Accounting for Stock-Based Compensation," as amended, addresses the financial accounting and reporting standards for stock or other equity-based compensation arrangements. The Company elected to continue to use the intrinsic value-based method to account for employee stock option awards under the provisions of Accounting Principles Board Opinion ("APB") No. 25, "Accounting for Stock Issued to Employees," and to provide disclosures based on the fair value method in the Notes to the Consolidated Financial Statements as permitted by SFAS No. 123. Under the intrinsic value method, compensation expense, if any, is recognized for the difference between the exercise price of the option and the fair value of the underlying common stock as of a measurement date. The measurement date is the time when both the number of shares and the exercise price is known. Stock or other equity-based compensation for non-employees must be accounted for under the fair value-based method as required by SFAS No. 123, and Emerging Issues Task Force ("EITF") No. 96-18, "Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services" and other related interpretations. Under this method, the equity-based instrument is valued at either the fair value of the consideration received or the equity instrument issued on the measurement date, which is generally the grant date. The resulting compensation cost is recognized and charged to operations over the service period, which is generally the vesting period. As described above, prior to January 1, 2006 the Company used the intrinsic value method to measure compensation expense associated with grants of stock options to employees. Had the Company used the fair value method to measure compensation, the net loss and net loss per share would have been reported as follows for the years ended December 31: F-8 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003
2005 2004 2003 ------------- ------------- ------------- Net loss: as reported $ (14,998,709) $ (15,628,980) $ (14,826,854) ------------- ------------- ------------- Add: stock-based compensation expense included in reported net loss 19,444 - - Deduct: effect on net loss if fair value method had been used (1,738,275) (2,275,678) (3,445,951) ------------- ------------- ------------- Net loss: pro forma $ (16,717,540) $ (17,904,658) $ (18,272,805) ============= ============= ============= Basic and diluted net loss per common share: as reported $ (0.89) $ (0.96) $ (1.06) ------------- ------------- ------------- Basic and diluted net loss per common share: proforma $ (0.99) $ (1.10) $ (1.31) ============= ============= =============
The fair value of the options at the date of grant was estimated using the Black-Scholes model with the following weighted average assumptions for the years ended December 31:
2005 2004 2003 ----- ----- ----- Expected life (years) 5 5 5 Risk free interest rate 3.97% 3.02% 3.02% Expected volatility 72.05% 76.40% 80.85% Dividend yield - - -
Using these assumptions, the weighted-average fair value per option granted during the years ended December 31, 2005, 2004, and 2003, was $6.71, $6.34, and $1.57, respectively. In December 2004, the Financial Accounting Standards Board ("FASB") issued SFAS No. 123(R), "Share-Based Payment," a revision of SFAS Statement No. 123. The Company adopted SFAS 123(R) effective January 1, 2006, using the modified prospective application method, and beginning with the first quarter of 2006 will be required to measure all employee share-based compensation awards using a fair value based method and record share-based compensation expense in its financial statements if the requisite service to earn the award is provided. The above disclosed pro forma results and assumptions used in fiscal years 2005, 2004 and 2003 were based solely on historical volatility of our common stock over the most recent period commensurate with the estimated expected life of our stock options. The adoption of SFAS No. 123(R) will not affect the Company's cash flow, but it will materially increase the Company's net loss and basic and diluted loss per common share. In accordance with SFAS 123R, the Company will recognize the expense attributable to stock awards that are granted or vest in periods ending subsequent to December 31, 2005. For 2006, total stock-based compensation expense is estimated to be in a range of $1,500,000 to $2,500,000. In order to develop the fiscal 2006 stock-based compensation expense estimate, we utilized assumptions including, among other items, projected option grants, volatility measures using a combination of historical and current and historical implied volatility, and expected life estimates for officer and non-officer employee groups. The amount of the 2006 grants, if any, have not yet been determined and could result in a change to the amounts included in the range reflected above. Total unrecognized stock-based compensation expense related to unvested stock options, expected to be recognized over approximately two years, amounted to $3,300,000 at December 31, 2005, net of forfeitures. F-9 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 o) COMPREHENSIVE LOSS - The Company has reported comprehensive loss and its components as part of its Consolidated Statements of Shareholders' Equity. Comprehensive loss, apart from net loss, relates to net unrealized gains and losses on marketable securities. p) SEGMENT REPORTING - The Company presently operates in one segment, which is the development and commercialization of emerging technologies that use drugs in combination with light to treat and detect disease. During the years ended 2005, 2004 and 2003, the Company derived revenues from the following geographies (as a percentage of product revenues):
2005 2004 2003 ---- ---- ---- UNITED STATES 87% 91% 100% CANADA 13% 9% - ---- ---- ---- TOTAL 100% 100% 100% ==== ==== ====
q) FAIR VALUE OF FINANCIAL INSTRUMENTS - The carrying value of the Company's financial assets and liabilities approximates their fair values due to their short-term nature. Marketable securities classified as available for sale are carried at fair market value. r) CONCENTRATION OF CREDIT RISK - The Company invests cash in accordance with a policy objective that seeks to preserve both liquidity and safety of principal. The Company manages the credit risk associated with its investments in marketable securities by investing in U.S. government securities and investment grade corporate bonds. The Company is also exposed to concentration of credit risk related to accounts receivable that are generated from its distributors and customers. To manage credit risk, the Company performs regular credit evaluations of its customers' and provides allowances for potential credit losses, when applicable. Concentrations in the Company's accounts receivable as of December 31, 2005 and 2004 and in the Company's revenues for the years ended December 31, 2005, 2004, and 2003, were as follows:
2005 2004 2003 -------------------- --------------------- ------- % OF % OF % OF ACCOUNTS % OF ACCOUNTS % OF REVENUE RECEIVABLE REVENUE RECEIVABLE REVENUE ------- ---------- ------- ---------- ------- Distributor A 16% - 31% 27% 89% Distributor B - - 17% - - Distributor C 13% 6% 5% 34% - Direct Customers 71% 94% 47% 39% 11% --- --- --- --- --- Total 100% 100% 100% 100% 100% === === === === ===
The Company is dependent upon sole-source suppliers for a number of its products. There can be no assurance that these suppliers will be able to meet the Company's future requirements for such products or parts or that they will be available at favorable terms. Any extended interruption in the supply of any such products or parts or any significant price increase could have a material adverse effect on the Company's operating results in any given period. s) RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS F-10 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 In November 2004, the FASB issued SFAS No. 151, "Inventory Costs, an amendment of ARB No. 43, Chapter 4." The amendments made by SFAS No. 151 clarify that abnormal amounts of idle facility expense, freight, handling costs, and wasted materials should be recognized as current-period charges and require the allocation of fixed production overheads to inventory based on the normal capacity of the production facilities. The provisions of SFAS No. 151 are effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The Company has adopted this standard beginning the first quarter of 2006 and does not believe the adoption will have a material impact on its results of operations or financial position as such costs have historically been expensed as incurred. In November 2005, FASB issued FASB Staff Position FAS 115-1 and FAS 124-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments" ("FSP FAS 115-1"), which provides guidance on determining when investments in certain debt and equity securities are considered impaired, whether that impairment is other-than-temporary, and on measuring such impairment loss. FSP FAS 115-1 also includes accounting considerations subsequent to the recognition of an other-than-temporary impairment and requires certain disclosures about unrealized losses that have not been recognized as other-than-temporary impairments. FSP FAS 115-1 is required to be applied to reporting periods beginning after December 15, 2005. We F-11 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31,2005, 2004, AND 2003 are required to adopt FSP FAS 115-1 in the first quarter of 2006. We do not expect the adoption of this statement will have a material impact on our results of operations or financial condition. 3) MARKETABLE SECURITIES The Company's investment securities consist of securities of the U.S. government and its agencies, and investment grade corporate bonds, all classified as available for sale. As of December 31, 2005, current yields range from 2.36% to 7.38% and maturity dates range from January 17, 2006 to June 15, 2008. The estimated fair value and cost of marketable securities were as follows as of December 31:
2005 ----------------------------------------------------- GROSS GROSS AMORTIZED UNREALIZED UNREALIZED COST GAINS LOSSES FAIR VALUE ------------ ---------- ---------- ------------ United States government debt securities $ 19,857,171 $ 3,732 $ (72,243) $ 19,788,660 Investment grade corporate debt securities 10,818,063 15,136 (42,373) 10,790,826 ------------ ---------- ---------- ------------ Total marketable debt securities $ 30,675,234 $ 18,868 ($114,616) $ 30,579,486 available for sale ============ ========== ========== ============
2004 ---------------------------------------------------- GROSS GROSS AMORTIZED UNREALIZED UNREALIZED COST GAINS LOSSES FAIR VALUE ------------ ---------- ---------- ----------- United States government debt securities $ 27,266,271 $ 389,585 ($ 15,315) $27,640,541 Investment grade corporate debt securities 18,625,317 504 (43,393) 18,582,428 ------------ --------- --------- ----------- Total marketable debt securities $ 45,891,588 $ 390,089 ($ 58,708) $46,222,969 available for sale ============ ========= ========= ===========
The change in net unrealized gains and losses on such securities for the years ended December 31, 2005, 2004 and 2003 was ($427,129), ($1,124,309) and ($1,178,820), respectively, and has been recorded in accumulated other comprehensive income, which is reported as part of shareholders' equity in the Consolidated Balance Sheets. Realized gains on sales of marketable securities were $75,000 in 2005. There were no realized gains or losses in 2004 or 2003. F-12 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 Because the Company has the ability and intent to hold these investments until a recovery of fair value, which may be maturity, the Company does not consider these investments to be other-than-temporarily impaired at December 31, 2005. F-13 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 4) INVENTORY Inventory consisted of the following at December 31:
2005 2004 ---------- ----------- Finished goods $ 1,004,772 $ 1,226,071 BLU-U(R) evaluation units 292,129 - Work in process 60,805 85,910 Raw materials 503,087 105,179 ----------- ----------- $ 1,860,793 $ 1,417,160 =========== ===========
BLU-U(R) commercial light sources placed in physicians' offices pursuant to the Company's BLU-U(R) evaluation program are classified as inventory in the accompanying Consolidated Balance Sheets. 5) RESTRUCTURING CHARGE During the quarter ended September 30, 2005, the Company eliminated 14 staff positions, representing 16% of the workforce, to align headcount more closely with management's assessment of its resource requirements at that time. These workforce reductions were made across all functions of the Company. As a result of these actions the Company recorded a restructuring charge of approximately $150,000. As of December 31, 2005, the Company had paid all of its obligations under the restructuring plan. F-14 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 6) PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment, at cost, consisted of the following at December 31:
USEFUL LIVES (YEARS) 2005 2004 ---------------------- ----------- ----------- Computer equipment and software 3 $ 2,389,562 $ 2,226,646 BLU-U units in physicians' offices 3 - 700,043 Furniture, fixtures and equipment 5 810,488 726,069 Manufacturing facility Term of lease 2,204,122 2,204,122 Manufacturing equipment 5 2,187,244 2,153,485 Leasehold improvements Lesser of their useful Lives or term of lease 833,967 699,892 ----------- ----------- 8,425,383 8,710,257 Accumulated depreciation and amortization (5,453,514) (5,228,369) $ 2,971,869 $ 3,481,888 =========== ===========
Depreciation and amortization totaled $925,000, $1,299,000, and $1,611,000 for 2005, 2004, and 2003, respectively. 7) OTHER ACCRUED EXPENSES Other accrued expenses consisted of the following at December 31:
2005 2004 ----------- ----------- Research and development costs $ 347,220 $ 778,926 Marketing and sales costs 173,092 153,167 Product related costs 667,388 261,444 Legal and other professional fees 488,401 374,142 Employee benefits 225,628 229,304 Other expenses 93,950 104,858 ----------- ----------- $ 1,995,679 $ 1,901,841 =========== ===========
8) INCOME TAXES The tax effect of significant temporary differences representing deferred tax assets and liabilities at December 31:
2005 2004 ----------- ------------ DEFERRED TAX ASSETS Deferred revenue $ 19,000 $ 93,000 Intangible assets 917,000 632,000 Accrued charges 60,000 51,000 Research and development tax credit carryforwards 2,720,000 2,593,000 Capitalized R&D 3,571,000 - Operating loss carryforwards 31,916,000 29,463,000 License fee 141,000 161,000 Reserves - ------------
F-15 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 102,000 ------------ Total deferred tax assets 39,446,000 32,993,000 ------------ ------------- DEFERRED TAX LIABILITIES Fixed assets (8,000) (8,000) ------------ ------------- Total deferred tax liabilities (8,000) (8,000) ------------ ------------- Net deferred tax assets before allowance 39,438,000 32,985,000 Valuation allowance (39,438,000) (32,985,000) ------------ ------------- Total $ - $ - ============ =============
During the years ended December 31, 2005, 2004, and 2003, the valuation allowance was increased by approximately $6,453,000, $5,503,000, and $5,022,000, respectively, due to the uncertainty of future realization of the net deferred tax assets which were increasing. Included in deferred tax assets at December 31, 2005 and 2004 is $1,817,000 and $1,600,000 of future benefits attributable to the exercise of stock options which, if realized, will be credited to additional paid-in capital rather than results of operations. As of December 31, 2005, the Company has Federal net operating loss carryforwards for tax purposes of approximately $79,261,000 and research and development tax credits of approximately $2,521,000, both of which, if not utilized, will expire for Federal tax purposes as follows:
RESEARCH AND OPERATING LOSS DEVELOPMENT TAX CARRYFORWARDS CREDITS -------------- --------------- 2010 $ 2,325,000 $ - 2011 6,638,000 7,000 2012 6,841,000 57,000 2013 - 66,000 2014 - 84,000 2015 - 44,000 2016 - 102,000 2017 - 235,000 2018 5,738,000 145,000 2019 - 81,000 2020 - 159,000 2021 1,772,000 343,000 2022 15,382,000 477,000 2023 12,716,000 232,000 2024 9,913,000 282,000 2025 17,936,000 207,000 ------------ ----------- $ 79,261,000 $ 2,521,000 ============ ===========
The tax loss carryforwards of the Company and its subsidiaries may be subject to limitation by Section 382 of the Internal Revenue Code with respect to the amount utilizable each year. The amount of the limitation, if any, has not been quantified by the Company. F-16 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 A reconciliation between the effective tax rate and the statutory Federal rate is as follows:
2005 2004 2003 --------------------- --------------------- -------------------- % % % ------------ ------- ------------ ------- ------------ ------ Income tax benefit at statutory rate ($5,100,000) (34.0) ($5,314,000) (34.0) ($5,041,000) (34.0) State taxes (939,000) (6.3) (979,000) (6.3) (930,000) (6.3) Tax credit carryforwards (234,000) (1.6) (435,000) (2.8) (329,000) (2.2) Change in valuation allowance including revisions of prior year estimates 6,233,000 41.6 6,676,000 42.7 6,268,000 42.3 Other 40,000 0.3 52,000 0.4 32,000 0.2 ---------- ---- ---------- ---- ---------- ---- $ - - $ - - $ - - ========== ==== ========== ==== ========== ====
9) SHAREHOLDERS' EQUITY COMMON STOCK ISSUANCES - In March 2005, the vesting period for 18,875 options to purchase shares of common stock was extended beyond the original terms and the vesting of 1,250 options was accelerated upon an employee's termination. As a result of this stock option modification, the Company recorded compensation expense of approximately $19,000 during 2005. The compensation expense was calculated using the intrinsic value method, which compares the common stock option exercise price to the fair market value of the underlying common stock on the date of modification. The stock compensation expense was recorded as part of general and administrative costs in the Consolidated Statement of Operations. On February 27, 2004, the Company completed a private placement of 2,250,000 shares of its common stock at a purchase price of $11.00 per share, resulting in gross proceeds of $24,750,000. The closing date of the private placement was March 2, 2004. The Company also granted the investors the right to purchase up to an aggregate of an additional 337,500 shares of common stock at $11.00 per share. These additional investment rights were exercised on April 14, 2004, resulting in additional gross proceeds of $3,712,500. Offering costs incurred in connection with the placement were $1,907,952, of which $1,707,750 consisted of the placement agent's commission and non-refundable retainer paid in the form of 155,250 shares of common stock calculated at the offering price. On March 18, 2004, the Company granted a total of 30,000 fully vested options to three consultants on its Medical Advisory Board as compensation for services. These options were valued at $240,753 and recorded as part of research and development costs in the Consolidated Statement of Operations. On December 30, 2004 the Company repurchased these options for a total cash payment of $240,000. On June 15, 2003, the Company granted compensation of $50,000 to Therapeutics, Inc. ("Therapeutics"), a clinical research organization, pursuant to an agreement for services. This compensation was issued in July 2003 and was comprised of 11,666 shares of common stock valued at $35,000 and $15,000 of cash. The transaction was recorded in research and development expense in the Consolidated Statements of Operations. On May 2, 2003, the Company granted a total of 32,750 shares of unregistered common stock to two outside consultants as compensation for services rendered. These shares were valued at approximately $75,000 and recorded as part of research and development costs in the Consolidated Statements of Operations. F-17 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 On March 13, 2003, the Company issued 23,219 shares of restricted common stock at the grant date fair value of $1.599 per share to its Chief Executive Officer, reflecting payment of the after-tax portion of his 2002 bonus compensation. This amount had been accrued in the December 31, 2002 financial statements. 10) STOCK OPTIONS AND WARRANTS a) 1996 OMNIBUS PLAN - The 1996 Omnibus Plan ("Omnibus Plan"), as amended, provides for the granting of awards to purchase up to a maximum of 20% of the Company's common stock outstanding or a maximum of 3,343,874 shares. The Omnibus Plan is administered by a committee ("Committee") established by the Board of Directors. The Omnibus Plan enables the Committee to grant non-qualified stock options ("NQSO"), incentive stock options ("ISO"), stock appreciation rights, restricted stock, or other securities determined by the Company, to directors, employees and consultants. NON-QUALIFIED STOCK OPTIONS - All the NQSOs granted under the Omnibus Plan have an expiration period not exceeding ten years and are issued at a price not less than the market value of the common stock on the grant date. NQSO grants to employees become exercisable at a rate of one quarter of the total granted on each of the first, second, third and fourth anniversaries of the grant date, subject to satisfaction of certain conditions involving continuous periods of service. In addition, the Company initially grants each individual who agrees to become a director 15,000 NQSO to purchase common stock of the Company. Thereafter, each director reelected at an Annual Meeting of Shareholders will automatically receive an additional 10,000 NQSO on June 30 of each year. Grants to directors immediately vest on the date of the grant. INCENTIVE STOCK OPTIONS - ISOs granted under the Omnibus Plan have an expiration period not exceeding ten years (five years for ISOs granted to employees who are also ten percent shareholders) and are issued at a price not less than the market value of the common stock on the grant date. These options become exercisable at a rate of one quarter of the total granted on each of the first, second, third and fourth anniversaries of the grant date, subject to satisfaction of certain conditions involving continuous periods of service. The following table summarizes information about all stock options outstanding at December 31, 2005:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE ------------------------------------ --------------------- WEIGHTED NUMBER AVERAGE WEIGHTED NUMBER WEIGHTED OUTSTANDING REMAINING AVERAGE EXERCISABLE AVERAGE AT DECEMBER CONTRACTUAL EXERCISE AT DECEMBER EXERCISE RANGE OF EXERCISE PRICE 31, 2005 LIFE PRICE 31, 2005 PRICE - ----------------------- ------------ ------------ -------- ----------- -------- $1.60 to 5.10 461,625 6.85 years $ 2.86 303,625 $ 2.96 5.11 to 7.75 503,750 1.15 years 7.41 503,750 7.41 7.76 to 9.92 681,125 6.39 years 9.55 445,939 9.42 9.93 to 27.31 899,750 6.60 years 14.22 456,000 17.15 31.00 to 31.00 304,000 4.18 years 31.00 304,000 31.00 --------- --------- 2,850,250 5.37 years $ 11.85 2,013,314 $ 12.95 ========= =========
F-18 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 Activity under stock option plans during the years ended December 31, 2005, 2004 and 2003 was as follows:
WEIGHTED WEIGHTED WEIGHTED AVERAGE AVERAGE AVERAGE EXERCISE EXERCISE EXERCISE 2005 PRICE 2004 PRICE 2003 PRICE --------- ------- --------- ------- --------- -------- Options outstanding, beginning of year 2,708,750 $ 11.62 2,444,950 $ 11.50 2,253,075 $ 12.95 Options granted 598,750 11.00 512,250 9.97 447,000 2.76 Options exercised (164,375) 5.65 (167,825) 4.50 (11,000) 2.99 Options cancelled (292,875) 11.46 (80,625) 12.28 (244,125) 11.21 --------- ------- --------- ------- --------- ------- Options outstanding, end of year 2,850,250 $ 11.85 2,708,750 $ 11.62 2,444,950 $ 11.50 ========= ======= ========= ======= ========= ======= Options exercisable, end of year 2,013,314 $ 12.95 1,924,625 $ 13.46 1,771,325 $ 12.59 ========= ======= ========= ======= ========= =======
Options that were granted during 2005, 2004 and 2003 have exercise prices ranging from $9.04 to $15.90 per share, $9.05 to $12.87 per share, and $1.60 to $5.20 per share, respectively. Options which were exercised during 2005, 2004 and 2003 were exercised at per share prices ranging from $1.60 to $9.92, $1.60 to $7.44, and $2.90 to $3.87, respectively. b) WARRANTS - On January, 17, 2002, the Company extended the term of 300,000 warrants, which were previously issued to the Chief Executive Officer of the Company, from January 29, 2002 to January 29, 2007. The warrants are convertible on a one-for-one basis into Shares of Common Stock. No compensation expense resulted from the extension of these warrants as the intrinsic value of these warrants at the date of extension was zero. As of December 31, 2005, all of these warrants were outstanding. The exercise price of the warrants is CDN $6.79 (U.S. $5.82 at December 31, 2005). 11) RETIREMENT PLAN Effective January 1, 1996, the Company adopted a tax-qualified employee savings and retirement 401(k) Profit Sharing Plan (the "401(k) Plan"), covering all qualified employees. Participants may elect a salary deferral of at least 1% as a contribution to the 401(k) Plan, up to the statutorily prescribed annual limit for tax-deferred contributions. Effective February 1, 2003, DUSA matches a participant's contribution up to 1.25% of a participant's salary (the "Match"), subject to certain limitations of the 401(k) Plan. Participants will vest in the Match at a rate of 25% for each year of service to DUSA. The Company's matching contributions in 2005, 2004 and 2003 were $42,000, $39,000 and $33,000, respectively. 12) COMMITMENTS AND CONTINGENCIES a) PARTEQ AGREEMENT - The Company licenses certain patents underlying its Levulan(R) PDT/PD systems under a license agreement with PARTEQ Research and Development Innovations, the licensing arm of Queen's University, Kingston, Ontario. Under the agreement, the Company has been granted an exclusive worldwide license, with a right to sublicense, under PARTEQ patent rights, to make, have made, use and sell certain products, including ALA. The agreement covers certain use patent rights. F-19 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 When the Company is selling its products directly, it has agreed to pay to PARTEQ royalties of 6% and 4% on 66% of the net selling price in countries where patent rights do and do not exist, respectively. In cases where the Company has a sublicensee, it will pay 6% and 4% when patent rights do and do not exist, respectively, on its net selling price less the cost of goods for products sold to the sublicensee, and 6% of payments the Company receives on sales of products by the sublicensee. For the years ended December 31, 2005, 2004 and 2003, actual royalties based on product sales were approximately $340,000, $229,000, and $36,000, respectively. However, based on the annual minimum royalty requirements, the Company incurred total royalty expense of $74,000 in 2003, which has been recorded in cost of product sales and royalties. Commencing with the initial product launch, annual minimum royalties to PARTEQ must total at least CDN $100,000 (U.S. $86,000 as of December 31, 2005). The Company is also obligated to pay to PARTEQ 5% of any lump sum sublicense fees received, such as milestone payments, excluding amounts designated by the sublicensee for future research and development efforts. No amounts have been paid to PARTEQ as a result of sublicense fees received. b) DRAXIS TERMINATION AND TRANSFER AGREEMENT - On February 24, 2004, the Company reacquired the rights to the aminolevulinic acid (Levulan(R)) technology for Canada held by Draxis Health Inc. ("Draxis"). These rights were initially assigned to Draxis in 1991. The Company and Draxis terminated the assignment and DUSA agreed to pay to Draxis an upfront fee of $150,000 CDN ($114,000 USD at February 24, 2004) and a 10% royalty on sales of the Levulan(R) Kerastick(R) in Canada over a five year term commencing in June 2004 based on the first Kerastick(R) sale in Canada by Coherent, our Canadian marketing and distribution partner. The upfront fee was capitalized and is being amortized over the five year term of the arrangement. At December 31, 2005, the remaining unamortized balance of $78,000 is included in deferred charges and other assets. The Company incurred total royalty expense of $116,000 and $56,000 in 2005 and 2004, respectively, which has been recorded in cost of product sales and royalties. c) LEASE AGREEMENTS - The Company has entered into lease commitments for office space in Wilmington, Massachusetts, Valhalla, New York, and Toronto, Ontario. These leases generally have five or ten year terms. The minimum lease payments disclosed below include the non-cancelable terms of the leases. Future minimum lease payments are as follows:
MINIMUM LEASE PAYMENTS ------------- 2006 $ 470,000 2007 469,000 2008 418,000 2009 432,000 2010 448,000 Beyond 2010 722,000 ------------ $ 2,959,000 ============
Rent expense incurred under these operating leases was approximately $477,000, $472,000, and $471,000 for the years ended December 31, 2005, 2004, and 2003, respectively. d) RESEARCH AGREEMENTS - The Company has entered into various agreements for research projects and clinical studies. As of December 31, 2005, future payments to be made pursuant to these agreements, under certain terms and conditions, totaled approximately $1,775,000 for 2006. Included in this future payment is a master service agreement, effective June 15, 2001, with F-20 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 Therapeutics, Inc. for an initial term of two years, with annual renewal periods thereafter, to engage Therapeutics to manage the clinical development of the Company's products in the field of dermatology. The agreement was renewed on June 15, 2005 for a one year period. Therapeutics is entitled to receive a bonus valued at $50,000, in cash or stock at the Company's discretion, upon each anniversary of the effective date. Therapeutics has the opportunity for additional stock grants, bonuses, and other incentives for each product indication ranging from $250,000 to $1,250,000 depending on the regulatory phase of development of products during Therapeutics' management. e) LEGAL MATTERS - In April 2002, we received a copy of a notice issued by PhotoCure ASA to Queen's University at Kingston, Ontario, alleging that Australian Patent No. 624985 was invalid. Australian Patent No. 624985 is one of the patents covered by our agreement with PARTEQ Research & Development Innovations, the technology transfer arm of Queen's University, relating to 5-aminolevulinic acid technology. PhotoCure instituted this proceeding on April 12, 2002 in the Federal Court of Australia, Victoria District Registry. As a consequence of this action, Queen's University assigned the Australian patent to us so that we could participate directly in this litigation. On April 6, 2005, the Federal Court of Australia ruled that the patent is valid and remains in full force and effect. However, the Court also ruled that PhotoCure's product does not infringe the claims in the Australian patent. Since these claims are unique to the Australian patent and Australian law differs from patent law in other jurisdictions, we do not expect that this decision is determinative of the validity of any other patents licensed by us from Queen's University or of whether PhotoCure's product infringes claims in such other patents, including the United States patent. None of the parties have appealed the decision and the date to do so has expired. The parties, including PhotoCure's marketing partner, Galderma S.A., signed a Mediation Agreement in August 2004 to attempt to settle their disputes and negotiations are on-going. In December 2004, we filed a lawsuit against New England Compounding Center of Framingham, Massachusetts alleging violations of U.S. patent law in the U.S. District Court in Boston, Massachusetts. On March 17, 2005, New England Compounding Pharmacy filed an answer against us, including a defense that our patents are invalid and several counterclaims against us, and we filed our response on April 5, 2005. The parties are now in the discovery stage of this litigation. A tentative trial date has been set by the court for January 2007. We are seeking injunctive relief, monetary damages and costs. In January 2005, we filed a lawsuit against The Cosmetic Pharmacy of Tucson, Arizona alleging violations of the Lanham Act for false advertising and trademark infringement, and of U.S. patent law in the U.S. District Court for the District of Arizona. A motion for default judgment was granted on July 25, 2005 in our favor for failure of The Cosmetic Pharmacy of Tucson to appear, together with injunctive relief and attorney fees and costs in the amount of $20,668. In November, 2005 and January, 2006 we filed lawsuits against physicians in several states to prevent their continued use of versions of our Levulan (R) brand of aminolevulinic acid HCl (ALA) produced, by third-parties for use in our patented photodynamic therapy (PDT) treatment for actinic keratosis, basal cell carcinoma, acne and other dermatological conditions. The suits allege that ALA obtained from sources other than DUSA is being used by physicians for patient treatments that are covered under patents exclusively licensed by DUSA, resulting in direct infringement of these patent(s). Additionally, some doctors are also being sued for misuse of DUSA's trademarks and for violations of the Lanham Act for using the Levulan (R) brand name on their web sites and promotional materials, but performing patient treatments with ALA obtained from other sources. Most of the physicians have entered Consent Judgments in which F-21 DUSA PHARMACEUTICALS, INC. NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2005, 2004, AND 2003 they admit the infringement and provide DUSA with the right to review their books and records. Two lawsuits are currently on-going. The Company has not accrued any amounts for these contingencies as of December 31, 2005, as these amounts are neither probable nor estimable. f) LICENSE AND SUPPLY AGREEMENTS - In December 2002, DUSA entered into a License and Development Agreement with photonamic GmbH & Co. KG, a subsidiary of medac GmbH, a German pharmaceutical company, and a supply agreement with medac. These agreements provide for the licensing to DUSA of photonamic's proprietary technology related to ALA for systemic dosing in the field of brain cancer. Based on the license agreement, DUSA made a non-refundable $500,000 milestone payment to photonamic in 2003. The Company may also be obligated to pay certain regulatory milestones including $1,250,000 upon FDA acceptance of a registration application for a brain cancer product in the U.S., and an additional $1,250,000 upon registration of the product and royalties of 12.5% on net sales under the terms of the License and Development Agreement. The Company will also purchase product under the supply agreement for mutually agreed upon indications. Should photonamic's clinical study be successful, DUSA will be obligated to proceed with development of the product in the U.S. in order to retain the license for the use of the technology to treat brain cancer. Such additional obligations are undeterminable at this time. g) AMENDED AND RESTATED PURCHASE AND SUPPLY AGREEMENT - On June 21, 2004, the Company signed an Amended and Restated Purchase and Supply Agreement with National Biological Corporation ("NBC"), the manufacturer of its BLU-U(R) light source. This agreement provides for the elimination of certain exclusivity clauses, permits the Company to order on a purchase order basis without minimums, and other modifications of the original agreement providing both parties greater flexibility related to the development and manufacture of light sources and the associated technology within the field of PDT. The Company paid $110,000 to NBC upon execution of the agreement which will be amortized over the remaining term of the agreement, expiring November 5, 2008. 13) PENDING TRANSACTION In December, 2005, we signed a definitive Merger Agreement to acquire all of the common stock of Sirius Laboratories Inc. of Vernon Hills, Illinois in exchange for cash and common stock worth up to $30,000,000. Sirius is a privately held dermatology specialty pharmaceuticals company founded in 2000 with a primary focus on the treatment of acne vulgaris and acne rosacea. Closing of the transaction is expected in the first quarter of 2006, subject to the terms and conditions in the Merger Agreement. Of the potential $30,000,000 consideration, $8,000,000 less certain expenses will be paid in cash upon closing, $17,000,000 will be paid in shares of DUSA's common stock also upon closing in a private placement, and up to $5,000,000 in cash or common stock may be paid based on a combination of new product approvals or launches, and achievement of certain pre-determined total cumulative sales milestones for Sirius products. The amount of DUSA common stock to be issued in the merger agreement will depend upon the average trading price of DUSA's common stock during a 20 trading-day period just prior to the closing. Included in the accompanying Consolidated Balance Sheets as of December 31, 2005 are deferred acquisition costs of approximately $830,000 related to the Sirius acquisition. If the negotiations are unsuccessful and a determination is made that the acquisition is not likely to close, the deferred acquisition costs will be expensed in the period such a determination is made. F-22 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. (Registrant) DUSA Pharmaceuticals, Inc. By (Signature and Title) /s/D. Geoffrey Shulman ------------------------ Chairman of the Board and Chief Executive Officer Date: March 10, 2006 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated. /s/ D. Geoffrey Shulman Director, Chairman of the Board and March 10, 2006 - ------------------------------- Chief Executive Officer (principal D. Geoffrey Shulman, MD, executive officer) FRCPC /s/ Robert F. Doman President, Chief Operating Officer March 10, 2006 - ------------------------------- Robert F. Doman /s/ Richard C. Christopher Vice President, Finance and Chief March 10, 2006 - ------------------------------- Financial Officer (principal financial Richard C. Christopher officer and principal accounting officer) /s/ John H. Abeles Director March 10, 2006 - ------------------------------- John H. Abeles /s/ David Bartash Director March 10, 2006 - ------------------------------- David Bartash /s/ Jay M. Haft Vice Chairman of the Board and Lead March 10, 2006 - ------------------------------- Director Jay M. Haft, Esq. /s/ Richard C. Lufkin Director March 10, 2006 - ------------------------------- Richard C. Lufkin /s/ Magnus Moliteus Director March 10, 2006 - ------------------------------- Magnus Moliteus
EXHIBIT INDEX 2(a.1)* Merger Agreement by and among the Company, Sirius Laboratories, Inc., and the shareholders of Sirius dated as of December 30, 2005; and 2(a.2) First Amendment to Merger Agreement by and among the Company, Sirius Laboratories, Inc. and the shareholders of Sirius, dated as of February 6, 2006. 3(a.1) Certificate of Incorporation, as amended, filed as Exhibit 3(a) to the Registrant's Form 10-K for the fiscal year ended December 31, 1998, and is incorporated herein by reference; 3(a.2) Certificate of Amendment to the Certificate of Incorporation, as amended, dated October 28, 2002 and filed as Exhibit 99.3 to the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2002, filed November 12, 2002 and is incorporated herein by reference; and 3(b) By-laws of the Registrant, filed as Exhibit 3 to the Registrant's current report on Form 8-K, filed on January 4, 2005, and is incorporated herein by reference. 4(a) Common Stock specimen, filed as Exhibit 4(a) to the Registrant's Form 10-K for the fiscal year ended December 31, 2002, and is incorporated herein by reference; 4(b) Class B Warrant, filed as Exhibit 4.3 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; 4(c) Rights Agreement filed as Exhibit 4.0 to Registrant's Current Report on Form 8-K dated September 27, 2002, filed October 11, 2002, and is incorporated herein by reference; and 4(d) Rights Certificate relating to the rights granted to holders of common stock under the Rights Agreement filed as Exhibit 4.0 to Registrant's Current Report on Form 8-K, dated September 27, 2002, filed October 11, 2002, and is incorporated herein by reference. 10(a) License Agreement between the Company, PARTEQ and Draxis Health Inc. dated August 27, 1991, filed as Exhibit 10.1 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; 10(b) ALA Assignment Agreement between the Company, PARTEQ, and Draxis Health Inc. dated October 7, 1991, filed as Exhibit 10.2 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; 10(b.1) Amended and Restated Assignment Agreement between the Company and Draxis Health, Inc. dated April 16, 1999, filed as Exhibit 10(b.1) to the Registrant's Form 10-K for the fiscal year ended December 31, 1999, and is incorporated herein by reference; 10(b.2) Termination and Transfer Agreement between the Company and Draxis Health Inc. dated as of February 24, 2004, filed as Exhibit 10(b.2) to the Registrant's Form 10-K for the fiscal year ended December 31, 2003, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(c) Employment Agreement of D. Geoffrey Shulman, MD, FRCPC dated October 1, 1991, filed as Exhibit 10.4 to the Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; + 10(d) Amendment to Employment Agreement of D. Geoffrey Shulman, MD, FRCPC dated April 14, 1994, filed as Exhibit 10.4 to the Registrant's Registration Statement on Form S-2, No. 33-98030, and is incorporated herein by reference; + 10(e) Amended and Restated License Agreement between the Company and PARTEQ dated March 11, 1998, filed as Exhibit 10(e) to the Registrant's Form 10-K/A filed on June 18, 1999, portions of Exhibit A have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(f) Incentive Stock Option Plan, filed as Exhibit 10.11 of Registrant's Registration Statement on Form S-1, No. 33-43282, and is incorporated herein by reference; + 10(g) 1994 Restricted Stock Option Plan, filed as Exhibit 1 to Registrant's Schedule 14A definitive Proxy Statement dated April 26, 1995, and is incorporated herein by reference; + 10(h) 1996 Omnibus Plan, as amended, filed as Appendix A to Registrant's Schedule 14A Definitive Proxy Statement dated April 26, 2001, and is incorporated herein by reference; + 10(h.1) 1996 Omnibus Plan, as amended on May 1, 2003, filed as Exhibit 10(h.1) to the Registrant's Form 10-K for the fiscal year ended December 31, 2003, and is incorporated herein by reference; + 10(h.2) 1996 Omnibus Plan, as amended April 23, 2004, filed as Appendix A to Registrant's Schedule 14A definitive Proxy Statement dated April 28, 2004, and is incorporated herein by reference; + 10(i) Purchase and Supply Agreement between the Company and National Biological Corporation dated November 5, 1998, filed as Exhibit 10(i) to the Registrant's Form 10-K/A filed on June 18, 1999, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(i.1) Amended and Restated Purchase and Supply Agreement between the Company and National Biological Corporation dated as of June 21, 2004 filed as Exhibit 10(a) to the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2004, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, filed August 11, 2004, and is incorporated herein by reference; 10(j) Supply Agreement between the Company and Sochinaz SA dated December 24, 1993, filed as Exhibit 10(q) to Registrant's Form 10-K/A filed on March 21, 2000, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(j.1) First Amendment to Supply Agreement between the Company and Sochinaz SA dated July 7, 1994, filed as Exhibit 10(q.1) to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1999, and is incorporated herein by reference; 10(j.2) Second Amendment to Supply Agreement between the Company and Sochinaz SA dated as of June 20, 2000, filed as Exhibit 10.1 to Registrant's Current Report on Form 8-K dated June 28, 2000, and is incorporated herein by reference; 10(j.3) Third Amendment to Supply Agreement between the Company and Sochinaz SA dated July 29, 2005, filed as Exhibit 10.1 to the Registrant's Form 10-Q filed on August 3, 2005, portions of which have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(k) Master Service Agreement between the Company and Therapeutics, Inc. dated as of October 4, 2001, filed as Exhibit 10(b) to the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2001, filed November 8, 2001, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended and is incorporated herein by reference; 10(l) License and Development Agreement between the Company and photonamic GmbH & Co. KG dated as of December 30, 2002, filed as Exhibit 10(r) to Registrant's Annual Report on Form 10- K for the fiscal year ended December 31, 2002, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b)-2 of the Securities Exchange Act of 1934, as amended and is incorporated herein by reference; 10(m) Supply Agreement between the Company and medac GmbH dated as of December 30, 2002, filed as Exhibit 10(r) to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2002, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b)-2 of the Securities Exchange Act of 1934, as amended and is incorporated herein by reference; 10(n) Securities Purchase Agreement dated as of February 27, 2004, by and among the Company and certain investors, filed as Exhibit 10.1 to the Registrant's current report on Form 8-K, filed on March 2, 2004, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b) of the Securities Exchange Act of 1934, as amended, and is incorporated herein by reference; 10(o) Registration Rights Agreement dated as of February 27, 2004 by and among the Company and certain investors, filed as Exhibit 10.2 to the Registrant's current report on Form 8-K, filed on March 2, 2004, and is incorporated herein by reference; 10(p) Form of Additional Investment Right dated as of February 27, 2004, filed as Exhibit 10.3 to the Registrant's current report on Form 8-K, filed on March 2, 2004, and is incorporated herein by reference; 10(q) License, Promotion, Distribution and Supply Agreement between the Company and Coherent-AMT dated as of March 31, 2004 filed as Exhibit 10(a) to the Registrant's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2004, filed May 4, 2004, and is incorporated herein by reference; 10(r) Employment Agreement of Scott L. Lundahl dated as of June 23, 1999 filed as Exhibit 10(u) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(s) Amended Employment Agreement of Stuart L. Marcus, MD, PhD dated December 9, 1999 filed as Exhibit 10(v) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(t) Employment Agreement of Mark C. Carota dated as of February 14, 2000 filed as Exhibit 10(w.1) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(t.1) First Amendment to Employment Agreement of Mark C. Carota dated October 31, 2001 filed as Exhibit 10(w.2) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(u) Employment Agreement of Paul A. Sowyrda dated as of July 31, 2001 filed as Exhibit 10(x) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(v) Employment Agreement of Richard Christopher dated as of January 1, 2004 filed as Exhibit 10(y) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(w) Employment Agreement of Robert F. Doman dated as of March 15, 2005 filed as Exhibit 10(z) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(x) Employment Agreement of Gary F. Talarico dated as of February 15, 2005 filed as Exhibit 10(aa) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(y) Severance Agreement and General Release between the Company and Peter Chakoutis dated as of February 25, 2005 filed as Exhibit 10(bb) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; + 10(y.1) Final Agreement and General Release, between the Company and Peter Chakoutis, dated as of April 4, 2005, filed as Exhibit 10.1 to the Registrant's Current Report on Form 8-K, filed on April 4, 2005, and is incorporated herein by reference; + 10(z) Compensation Policy Applicable to the Company's Non-Employee Directors filed as Exhibit 10(cc) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference; and + 10(aa) Marketing, Distribution and Supply Agreement between the Company and Stiefel Laboratories, Inc., dated as of January 12, 2006, portions of which have been omitted pursuant to a request for confidential treatment under Rule 24(b)-2 of the Securities Exchange Act of 1934, as amended. 14(a) Form of DUSA Pharmaceuticals, Inc. Code of Ethics Applicable to Senior Officers filed as Exhibit 14(a) to the Registrant's Form 10-K for the fiscal year ended December 31, 2004, and is incorporated herein by reference. 21(a) Subsidiaries of the Registrant. 23(a) Consent of Deloitte & Touche LLP, Independent Registered Public Accounting Firm. 31(a) Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer; and 31(b) Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer. 32(a) Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002; and 32(b) Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. - ------------- + Management contract or compensatory plan or arrangement. * Schedules and exhibits omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the Commission upon request.
EX-2.A.1 2 y18270exv2waw1.txt MERGER AGREEMENT EXECUTION COPY EXHIBIT 2(A.1) MERGER AGREEMENT BY AND AMONG DUSA PHARMACEUTICALS, INC., SIRIUS LABORATORIES, INC., AND THE SHAREHOLDERS OF SIRIUS LABORATORIES, INC. SET FORTH ON THE SIGNATURE PAGES ATTACHED HERETO DECEMBER 30, 2005 TABLE OF CONTENTS
PAGE ARTICLE I DEFINITIONS............................................................................. 1 ARTICLE II MERGER; CLOSING........................................................................ 11 2.1 Merger....................................................................... 11 2.2 Consideration................................................................ 11 2.3 Closing...................................................................... 13 2.4 Closing Obligations.......................................................... 13 2.5 Liability Escrow............................................................. 15 2.6 Lock-Up...................................................................... 16 2.7 Registration Rights.......................................................... 17 2.8 Assumption of Sirius Liabilities............................................. 17 2.9 Shareholders and Expense Escrow.............................................. 17 ARTICLE III REPRESENTATIONS AND WARRANTIES REGARDING SIRIUS....................................... 18 3.1 Organization and Good Standing............................................... 18 3.2 Authority; No Conflict; Consents............................................. 18 3.3 Capitalization............................................................... 19 3.4 Financial Statements......................................................... 20 3.5 Books and Records............................................................ 20 3.6 Title to Assets; Encumbrances................................................ 20 3.7 Revolving Credit and Other Debt.............................................. 21 3.8 Subsidiaries................................................................. 21 3.9 Intellectual Property Matters................................................ 21 3.10 Related Party Transactions................................................... 22 3.11 No Undisclosed Liabilities................................................... 22 3.12 Taxes........................................................................ 23 3.13 Employee Benefits............................................................ 24 3.14 Compliance with Legal Requirements; Governmental Authorizations.............. 27 3.15 Legal Proceedings............................................................ 29 3.16 Absence of Certain Changes and Events........................................ 30 3.17 Material Contracts; No Defaults.............................................. 31 3.18 Insurance.................................................................... 32 3.19 Environmental Matters........................................................ 34 3.20 Brokers or Finders........................................................... 36 3.21 Accounts Receivable.......................................................... 36 3.22 Inventory.................................................................... 36 3.23 Warranties................................................................... 36 3.24 Product Liability............................................................ 36 3.25 Customers and Suppliers...................................................... 37 3.26 Product Treatments; Product Returns.......................................... 37 3.27 Complete Copies of Materials................................................. 37 3.28 Disclosures.................................................................. 37 3.29 Principal Shareholders....................................................... 37
-i- 3.30 Representations Complete..................................................... 38 ARTICLE IV REPRESENTATIONS AND WARRANTIES OF PRINCIPAL SHAREHOLDERS............................... 38 4.1 Legal Capacity, Organization and Good Standing............................... 38 4.2 Authority; No Conflict....................................................... 38 4.3 Ownership of Shares.......................................................... 39 4.4 No Public Sale or Distribution............................................... 39 4.5 Reliance on Exemptions....................................................... 39 4.6 Information.................................................................. 39 4.7 No Governmental Review....................................................... 40 4.8 Transfer or Resale........................................................... 40 4.9 Legends...................................................................... 40 4.10 Brokers or Finders........................................................... 41 4.11 Representations Complete..................................................... 41 ARTICLE V REPRESENTATIONS AND WARRANTIES OF DUSA.................................................. 41 5.1 Organization and Good Standing............................................... 41 5.2 Authority; No Conflict....................................................... 41 5.3 Investment Intent............................................................ 42 5.4 Certain Proceedings.......................................................... 42 5.5 Brokers or Finders........................................................... 42 5.6 DUSA Sub..................................................................... 42 5.7 No Undisclosed Liabilities................................................... 42 5.8 Representations Complete..................................................... 42 5.9 Compliance with Legal Requirements........................................... 42 5.10 SEC Compliance............................................................... 42 5.11 No Contemplated Sale of DUSA................................................. 43 ARTICLE VI ADDITIONAL AGREEMENTS.................................................................. 43 6.1 Approvals of Governmental Bodies............................................. 43 6.2 Tax Matters.................................................................. 44 6.3 Expenses..................................................................... 44 6.4 Sirius Shareholders' Representatives......................................... 45 6.5 Sirius Information Statement................................................. 45 6.6 Sirius Shareholder Meeting................................................... 45 6.7 Investor Questionnaires...................................................... 45 6.8 Unaccredited Investors....................................................... 46 6.9 Transition................................................................... 46 6.10 Due Diligence................................................................ 46 6.11 Micanol License Agreement.................................................... 46 ARTICLE VII CONDITIONS PRECEDENT TO DUSA'S OBLIGATION TO CLOSE.................................... 46 7.1 Accuracy of Representations.................................................. 47 7.2 Covenants.................................................................... 47
-ii- 7.3 Board and Shareholder Approval............................................... 47 7.4 Closing Deliverables......................................................... 47 7.5 Consents..................................................................... 47 7.6 No Proceedings............................................................... 47 7.7 Termination of Sirius Employee Plans......................................... 47 7.8 Financial Statements......................................................... 47 7.9 Minimum Participation........................................................ 48 7.10 FIRPTA Affidavit............................................................. 48 7.11 Non-Competition.............................................................. 48 7.12 Access to Manufacturing and Distribution Facilities.......................... 48 7.13 No Dropped Coverage.......................................................... 48 7.14 Extending Reporting Endorsement.............................................. 49 7.15 Waiver of Right of First Refusal to Purchase Bioglan Shares.................. 49 7.16 Key Contracts................................................................ 49 7.17 Adverse Event Reporting...................................................... 49 7.18 Product Registrations........................................................ 49 7.19 Effective Form S-4........................................................... 49 7.20 Qualification Fees........................................................... 49 7.21 Schedules.................................................................... 49 7.22 Disclosures.................................................................. 49 ARTICLE VIII CONDITIONS PRECEDENT TO SHAREHOLDERS AND SIRIUS'S OBLIGATION TO CLOSE................ 50 8.1 Accuracy of Representations.................................................. 50 8.2 Covenants.................................................................... 50 8.3 Board Approval............................................................... 50 8.4 Closing Deliverables......................................................... 50 8.5 No Proceedings............................................................... 50 8.6 Disclosures.................................................................. 50 ARTICLE IX COVENANTS OF SIRIUS PRIOR TO CLOSING DATE.............................................. 50 9.1 Access and Investigations.................................................... 50 9.2 Operation of Sirius.......................................................... 51 9.3 Negative Covenant............................................................ 51 9.4 Required Approvals........................................................... 51 9.5 Standstill................................................................... 52 9.6 Employee Plans............................................................... 53 9.7 Representation and Warranty Insurance........................................ 53 ARTICLE X POST-CLOSING COVENANTS.................................................................. 53 10.1 Sirius Board Nominee......................................................... 53 10.2 Maintenance of Sirius D&O Insurance.......................................... 54 10.3 Continuity of Sirius Business................................................ 54 10.4 Product Development and Marketing Requirements............................... 54
-iii- ARTICLE XI TERMINATION............................................................................ 55 11.1 Termination Events........................................................... 55 11.2 Effect of Termination........................................................ 56 11.3 Break-Up Fee................................................................. 56 ARTICLE XII SURVIVAL OF REPRESENTATIONS, WARRANTIES, COVENANTS AND AGREEMENTS..................... 57 12.1 Representations and Warranties............................................... 57 12.2 Limitation of Liability...................................................... 57 ARTICLE XIII INDEMNIFICATION...................................................................... 57 13.1 Indemnification of DUSA Indemnitees.......................................... 57 13.2 Indemnification of the Sirius Shareholders................................... 57 13.3 Limitations.................................................................. 58 13.4 General Provisions........................................................... 59 13.5 Procedures for Indemnification - Third Party Claims.......................... 59 13.6 Procedure for Indemnification - Other Claims................................. 61 ARTICLE XIV TAX MATTERS........................................................................... 61 14.1 Tax Allocation............................................................... 61 ARTICLE XV GENERAL PROVISIONS..................................................................... 62 15.1 Expenses..................................................................... 62 15.2 Public Announcements......................................................... 62 15.3 Confidentiality.............................................................. 62 15.4 Notices...................................................................... 62 15.5 Jurisdiction; Service of Process............................................. 63 15.6 Further Assurances........................................................... 64 15.7 Waiver....................................................................... 64 15.8 Entire Agreement and Modification............................................ 64 15.9 Disclosure Schedules......................................................... 64 15.10 Assignments, Successors, and No Third-Party Rights........................... 64 15.11 Severability................................................................. 65 15.12 Article and Section Headings, Construction................................... 65 15.13 Governing Law................................................................ 65 15.14 Counterparts................................................................. 65 ARTICLE XVI DISPUTE RESOLUTION.................................................................... 65 16.1 Arbitration.................................................................. 65 16.2 Judicial Proceedings......................................................... 66
-iv- DISCLOSURE SCHEDULES Schedule 1.80 New Products Schedule 1.95 Products Schedule 1.100 Management Bonus Program Schedule 2.8 Assumed Liabilities Schedule 3.1(a) Executive Officers and Directors of Sirius Schedule 3.2(b) No Conflict Schedule 3.2(c) Consents Schedule 3.3(a) Capitalization and Shareholders Schedule 3.3(b) Equity Incentive Plans/Options Schedule 3.3(c) Shareholder Agreements Schedule 3.3(d) Beneficial Ownership (Fully Diluted) Schedule 3.4 Financial Statements Schedule 3.6 Property and Assets Schedule 3.8 Subsidiaries Schedule 3.9(a) Intellectual Property Rights Schedule 3.9(c) Claims, Judgments and Disputes Schedule 3.10 Related Party Transactions Schedule 3.11 Undisclosed Liabilities Schedule 3.12(c) Tax Returns Schedule 3.13(b) Plans and Other Benefit Obligations Schedule 3.13(c) Effect of Transaction Schedule 3.14(a) Compliance with Legal Requirements Schedule 3.14(b) Governmental Authorization Schedule 3.14(c) Prescription and Non-Prescription Products Schedule 3.15 Legal Proceedings Schedule 3.16 Absence of Certain Changes and Events Schedule 3.17(a) Material Contracts Schedule 3.17(b) Restrictive Contracts Schedule 3.17(c) Validity of Material Contracts Schedule 3.17(d) Material Compliance Schedule 3.18(b) Insurance Schedule 3.18(c) Validity of Insurance Schedule 3.18(d) Claims-Made Policies Schedule 3.19(b) Facilities Schedule 3.21 Accounts Receivable Schedule 3.23 Warranties Schedule 3.24 Product Liability Schedule 3.25 Customers and Suppliers Schedule 3.26 Products Treatments; Product Returns Schedule 4.2(b) No Conflict Schedule 4.2(c) Consents Schedule 9.6 Employee Plans
-v- EXHIBITS Exhibit A Form of Subscription Agreement Exhibit B Form of Liability Escrow Agreement Exhibit C Form of Registration Rights Agreement Exhibit D Form of Shareholders Escrow Agreement Exhibit E Form of Expense Escrow Agreement Exhibit F Undisclosed Liabilities of DUSA Exhibit G Form of the 2006 Micanol License Agreement Exhibit H1 Form of Non-Competition Agreement Exhibit H2 Form of Non-Competition Agreement Exhibit I Form of Amendment to Harmony Supply and Development Agreement Exhibit J Form of Amendment to Amide Supply Agreement
-vi- EXECUTION COPY MERGER AGREEMENT THIS MERGER AGREEMENT (this "Agreement") is made on the 30th day of December, 2005, by and among DUSA Pharmaceuticals, Inc., a publicly traded pharmaceutical company incorporated in the State of New Jersey, with principal offices at 25 Upton Drive, Wilmington, Massachusetts ("DUSA"), Sirius Laboratories, Inc., a privately held specialty pharmaceutical company incorporated in the State of Illinois, with principal offices at 100 Fairway Drive, Suite 130, Vernon Hills, Illinois ("Sirius"), and those shareholders of Sirius set forth on the signature pages hereto (each a "Principal Shareholder" and collectively the "Principal Shareholders"). DUSA, Sirius and the Principal Shareholders are at times referred to each as a "Party" and collectively as the "Parties." RECITALS WHEREAS, pursuant to a Plan of Merger and Reorganization, to be drafted in a form mutually agreeable to the parties and delivered prior to the Closing Date (the "Plan of Merger"), the Parties agree to effect a merger of Sirius with and into a wholly-owned subsidiary of DUSA ("DUSA Sub") to be incorporated by DUSA prior to Closing, resulting in DUSA Sub being the surviving entity, the Sirius Shareholders receiving the consideration provided for herein, and DUSA owning all of the issued and outstanding common stock of DUSA Sub (the "Transaction"); WHEREAS, the Parties intend that the Transaction constitute a "reorganization" as defined in IRC Section 368(a); and WHEREAS, the Parties agree to effect the Transaction and agree to be bound by the terms and conditions set forth in this Agreement; NOW, THEREFORE, the Parties, in furtherance of the foregoing and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, intending to be legally bound, agree as follows: ARTICLE I DEFINITIONS For purposes of this Agreement, the following terms have the meanings specified or referred to in this Article I: 1.1 "Accounts Receivable" means all of Sirius's trade accounts receivable, notes receivable, employee advances and other miscellaneous receivables. 1.2 "Affiliates" means, with respect to any Person, any Persons directly or indirectly controlling, controlled by, or under common control with, such Person. For purposes hereof, the term "controlled" (including the terms "controlling," "controlled by," and "under common control with"), as used with respect to any Person, shall mean the direct or indirect ability or power to direct or cause the direction of management policies of such Person or otherwise direct the affairs of such Person, whether through ownership of voting securities or otherwise. 1.3 "Agreement" has the meaning defined in the opening paragraph of this Agreement. 1.4 "Altana" means Altana Inc., a New York corporation. 1.5 "Altana Agreement" means the Development, License and Supply Agreement, dated as of June 13, 2005, by and between Sirius and Altana. 1.6 "Amide" means Amide Pharmaceuticals, Inc., a New Jersey corporation. 1.7 "Amide Supply Agreement" means the Supply Agreement, dated as of May 18, 2001, by and between Sirius and Amide. 1.8 "Balance Sheet" has the meaning defined in Section 3.4. 1.9 "Break-Up Fee" means One Hundred Twenty Five Thousand Dollars ($125,000) on or before February 7, 2006, or Two Hundred Fifty Thousand Dollars ($250,000) thereafter. 1.10 "Business Day" means any day other than a Saturday, Sunday or federal holiday. 1.11 "Closing" has the meaning defined in Section 2.3. 1.12 "Closing Date" has the meaning defined in Section 2.3. 1.13 "Closing Deliverables" has the meaning defined in Section 2.4(a). 1.14 "Commercially Reasonable Efforts" means the efforts that a Party desirous of achieving a business result would use in similar circumstances, to ensure that such result is achieved in the context of such Party's business; provided, however, that an obligation to use Commercially Reasonable Efforts does not require the Party subject to that obligation to assume any Material obligations or pay any Material amounts outside the normal course of its business. 1.15 "Consent" means any approval, consent, ratification, waiver, or other authorization, including any Governmental Authorization. 1.16 "Consideration" has the meaning defined in Section 2.2. 1.17 "Contract" means any agreement, contract, license, sublicense, obligation, promise, or undertaking (whether written or oral and whether express or implied) that is legally binding. 1.18 "Damages" means any and all losses, damages, liabilities, obligations, costs and expenses, including without limitation, reasonable fees and disbursements of counsel, sustained or incurred by the applicable Person after deducting therefrom: (a) any Tax benefit actually recognized by the Person resulting from such Damages; and (b) any insurance proceeds in the order specified in Section 13.3(b) and any indemnity, contribution or other similar payment actually recovered, net of all expenses incurred in prosecuting such claim, by the Person suffering the Damages from any Third Party with respect thereto. 2 1.19 "Disclosure Schedules" means, collectively, those schedules delivered by Sirius and attached to and incorporated in this Agreement that set forth the facts and circumstances that qualify the representations and warranties of Sirius in Article III and the Principal Shareholders in Article IV of this Agreement, and "Schedule" means any schedule comprising part of the Disclosure Schedules. 1.20 "Dissenters Escrow Account" shall have the meaning defined in Section 2.9(a). 1.21 "Dissenters Escrow Amount" shall be an amount equal to Thirty Million Dollars ($30,000,000) less the Sirius Transaction Expenses and the Expense Escrow Amount multiplied by the Dissenters Multiplier, which amount is to be held in escrow by the Shareholders Escrow Agent pursuant to the terms and conditions of the Shareholders Escrow Agreement. 1.22 "Dissenters Multiplier" means the total number of Sirius Shares held by the Dissenting Shareholders as of the Closing Date divided by the total number of Sirius Shares issued and outstanding as of the Closing Date. 1.23 "Dissenting Shareholders" means those shareholders of Sirius who dissent from, refuse to participate in or otherwise fail to take part in the Transaction. 1.24 "Dollars" means the United States Dollar. 1.25 "Draft Financial Statements" has the meaning defined in Section 3.4. 1.26 "DUSA" has the meaning defined in the opening paragraph of this Agreement. 1.27 "DUSA Change of Control" has the meaning defined in Section 2.2(d). 1.28 "DUSA SEC Documents" means the reports, registration statements and definitive proxy statements filed by DUSA with the SEC since January 1, 2004. 1.29 "DUSA Shares" means shares of common stock, no par value per share, of DUSA, having the restrictions set forth in Sections 4.8 and 4.9. 1.30 "DUSA Sub" has the meaning defined in the Recitals of this Agreement. 1.31 "Elorac" means Elorac Limited, an Illinois partnership. 1.32 "Elorac Agreement" means the Sale and Purchase Agreement, dated as of December 18, 2002, by and between Sirius and Elorac. 1.33 "Employee" means any current employee, consultant or agent of Sirius or its ERISA Affiliates. 1.34 "Encumbrance" means any mortgage, easement, right of way, charge, claim, equitable interest, lien, option, pledge, security interest, right of first refusal, or restriction of any kind, including any restriction on use, voting, transfer, receipt of income, or exercise of any other attribute of ownership. 3 1.35 "Environmental Claim" has the meaning defined in Section 3.19(a). 1.36 "Environmental Laws" has the meaning defined in Section 3.19(a). 1.37 "Environmental Permits" has the meaning defined in Section 3.19(a). 1.38 "ERISA" means the Employee Retirement Income Security Act of 1974, as amended, or any successor law, and regulations and rules issued pursuant to that Act or any successor law. 1.39 "ERISA Affiliate" has the meaning defined in Section 3.13(a). 1.40 "Escrow Agent" means the Expense Escrow Agent, Shareholders Escrow Agent and/or the Liability Escrow Agent, as applicable. 1.41 "Exchange Act" means the Securities Exchange Act of 1934, as amended. 1.42 "Expense Escrow Account" shall have the meaning defined in Section 2.9(b). 1.43 "Expense Escrow Agent" shall have the meaning defined in Section 2.9(b). 1.44 "Expense Escrow Agreement" shall have the meaning defined in Section 2.9(b). 1.45 "Expense Escrow Amount" means the amount of the Consideration to be delivered to the Expense Escrow Agent at Closing for payment of expenses arising after the Closing pursuant to the Expense Escrow Agreement. 1.46 "Expenses" has the meaning defined in Section 6.3(a). 1.47 "Fair Market Value" means for purposes of Section 2.2(c)(ii), the average closing price of DUSA Shares on the NASDAQ Stock Market for the last twenty (20) trading days of the month in which the applicable milestone is achieved, which average closing price shall be calculated by adding the closing price of DUSA Shares for each of the twenty (20) designated days and dividing the sum by twenty (20); and shall mean for purposes of Sections 2.2(b) and 2.5 the average closing price of DUSA Shares on the NASDAQ Stock Market for the twenty (20) trading days prior to the public announcement of the Transaction by DUSA, which average closing price shall be calculated by adding the closing price of DUSA Shares for each of the twenty (20) designated days and dividing the sum by twenty (20). If the closing price cannot be calculated for the DUSA Shares on a particular date on any of the foregoing bases, the closing price of such security on such date shall be the fair market value as mutually determined by DUSA and the Shareholder Representatives. DUSA and the Shareholder Representatives shall use Commercially Reasonable Efforts to resolve any dispute regarding the determination of Fair Market Value, provided, however, that the limitation with respect to Material expenditures shall not apply. All such determinations shall be appropriately adjusted for any stock dividend, stock split, stock combination or other similar transaction during the applicable calculation period. Should DUSA Shares cease to be quoted on the NASDAQ Stock Market, for purposes of any calculation hereunder, the NASDAQ Stock Market shall be replaced by the applicable exchange or quotation system or in the event the DUSA Shares cease to trade on any exchange or 4 quotation system, then the determination of Fair Market Value shall be mutually determined by DUSA's Board of Directors and the Shareholders' Representatives. 1.48 "FDA" means the United States Food and Drug Administration, or any successor agency. 1.49 "FDCA" means the United States Food, Drug and Cosmetic Act, as amended, or any successor law, and the rules and regulations issued pursuant to that Act or successor law. 1.50 "Final Financial Statements" has the meaning defined in Section 3.4. 1.51 "Floor" means Twenty Five Thousand Dollars ($25,000). 1.52 "Form S-4" has the meaning defined in Section 6.8. 1.53 "Governmental Authorization" means any approval, consent, license, permit, certification, registration, waiver, or other authorization issued, granted, given, or otherwise made available by or under the authority of any Governmental Body or pursuant to any Legal Requirement. 1.54 "Governmental Body" means any: (a) nation, state, county, city, town, village, district, or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign, or other government; (c) governmental or quasi-governmental authority of any nature, including any governmental agency, branch, department, official, or entity and any court or other tribunal; or (d) body exercising, or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory, or taxing authority or power of any nature. 1.55 "Harmony" means Harmony Laboratories, Inc., a North Carolina corporation. 1.56 "Harmony Supply and Development Agreement" means the Supply and Development Agreement, dated as of September 18, 2001, by and between Sirius and Harmony Laboratories, Inc. 1.57 "Hazardous Materials" has the meaning defined in Section 3.19(a). 1.58 "Indemnitee" and "Indemnitor" have the respective meanings defined in Section 13.5. 1.59 "Intellectual Property Rights" means any item of or right under any and all Know-how, Patents, inventions, trademarks, trade names, domain names, service marks, trade dress, slogans, designs, concepts, compilations of information, copyrights, or any application or registration thereof, whether by ownership or license or the ability of an entity to grant access to, or a license or sublicense of, such item or right, and any and all inventions, improvements or discoveries in connection therewith. 1.60 "Interim Balance Sheet" has the meaning defined in Section 3.4. 5 1.61 "Inventory" means all inventory of Sirius's business held for resale and all raw materials, work in process, finished products, shipments in transit, wrapping and supply and packaging items exclusively used or held for use in Sirius's business, including, without limitation, inventory held for distribution to physicians as samples. 1.62 "Investor Questionnaires" has the meaning defined in Section 6.7. 1.63 "IRC" means the Internal Revenue Code of 1986, as amended, or any successor law, and regulations issued by the IRS pursuant to the Internal Revenue Code or any successor law. 1.64 "IRS" means the United States Internal Revenue Service or any successor agency, and, to the extent relevant, the United States Department of the Treasury. 1.65 "Know-how" means any and all unpatented formulae, processes, trade secrets, technologies and know-how, whether or not patentable, including, without limitation, synthesis, preparation, recovery and purification processes and techniques, control methods and assays, chemical data, toxicological and pharmacological data and techniques, clinical data, medical uses, product forms and product formulations and specifications. 1.66 "Knowledge" means to the applicable person's actual knowledge after reasonable inquiry. 1.67 "Legal Requirement" means any administrative order, constitution, law, ordinance, principle of common law, court order, consent, decree, rule, regulation, guidance, license, permit, statute, or treaty of any Governmental Body. 1.68 "Liability Escrow Account" has the meaning defined in Section 2.5. 1.69 "Liability Escrow Agent" has the meaning defined in Section 2.5. 1.70 "Liability Escrow Agreement" has the meaning defined in Section 2.5. 1.71 "Liability Escrow Amount" has the meaning defined in Section 2.5. 1.72 "Material" means, (i) when used in connection with a monetary amount, an amount of Twenty Five Thousand Dollars ($25,000) or more; and (ii) when used with respect to a non-monetary concepts or a concept that is both monetary and non-monetary, information that a reasonably prudent person would find important in deciding to take an action (or not take an action). 1.73 "Material Adverse Effect (or Change)" means (i) any effect or change that is Materially adverse to the business, assets, condition (financial or otherwise), operating results, or operations of a particular Person taken as a whole, including, without limitation, a court order or permanent injunction with respect to the continued manufacturing, production and/or marketing of a Product or the engaging of counsel with respect to any Third Party Intellectual Property Rights Materially affecting the Products, (ii) a Material impairment of such Person's ability to consummate the Transaction; (iii) a greater than five percent (5%) detrimental deviation between 6 the 2003 Draft Financial Statements and the 2003 Final Financial Statements, the 2004 Draft Financial Statements and the 2004 Final Financial Statements, and the September 30, 2005 Sirius management financial statements and the 2005 Final Financial Statements, respectively, with respect to net sales and/or profit/loss with the exception of variances caused by adjustments related to revenue recognition, compensation expense, and reserves for returns and allowances, or (iv) the failure by Sirius to deliver the Final Financial Statements as provided for herein. 1.74 "Material Contracts" has the meaning defined in Section 3.17(a). 1.75 "Milestone Payments" means the payments to be made upon the satisfaction of the conditions and the absence of certain events set forth in Section 2.2(c), subject to adjustments, if any. 1.76 "Milestone Termination Date" means the date that is forty-two (42) months after the Closing Date. 1.77 "Minimum Marketing Standards" means Commercially Reasonable Efforts to sell and/or promote the New Products selected for development pursuant to this Agreement (including to achieve marketing launch and/or regulatory approval of such New Products subject to the terms of Section 10.4(c) permitting DUSA to cease development of any New Product candidate) and the Products (as applicable) in a manner consistent with Sirius's past practices (including merely sampling certain Products) or the customary practices within the industry, including, without limitation, sales force promotion, sales incentive bonuses, product sampling and non-personal promotion, all at levels consistent with good faith operations of DUSA aimed at providing Sirius Shareholders with a realistic opportunity to achieve the sales milestones described in Section 2.2(c); provided, however, that it is understood and agreed that (a) the sales force used in working towards achieving the Minimum Marketing Standards will not be required to exclusively promote the New Products and the Products and may simultaneously promote DUSA's other existing and future products and services, and (b) the monetary amounts expended and activity levels applied to such marketing efforts by DUSA may be greater or less than the amounts and levels currently expended and applied by Sirius. 1.78 "Multi-Employer Plan" has the meaning defined in Section 3.13(a). 1.79 "Net Sales" means with respect to any Product and New Product, the gross amount invoiced by DUSA to unrelated third parties for such Product and New Product less deductions for: (a) sales and excise taxes and duties and any other governmental charges imposed upon the production, importation, use or sale of any Product or New Product; (b) trade, quantity and cash discounts actually allowed; (c) allowances or credits to customers on account of rejection or return of any Product or New Product or on account of retroactive price reductions affecting any Product or New Product; and (d) product rebates and charge backs, including those granted to governmental agencies, managed care entities and pharmaceutical benefit management service entities; in each case, as accounted for in accordance with United States Generally Accepted Accounting Principles, as applicable, or their equivalents in other countries, as applicable, but in any case, consistently applied. 1.80 "New Products" means the product candidates set forth on Schedule 1.80 hereto. 7 1.81 "Organizational Documents" means the articles or certificate of incorporation (including without limitation certificate(s) of designation), bylaws, certificate(s) of authority to conduct business, and any amendment to any of the foregoing, of a corporation. 1.82 "Other Benefit Obligation" has the meaning defined in Section 3.13(a). 1.83 "Paid Sirius Expenses" means any Sirius Transaction Expenses which have been or will be paid by Sirius prior to the Closing. 1.84 "Participating Shareholders" means the Principal Shareholders and other Sirius Shareholders who exchange their Sirius Shares for DUSA Shares at the Closing and who collectively hold greater than ninety percent (90%) of the issued and outstanding Sirius Shares on a fully diluted basis on the Closing Date, and, if approved by the requisite number of Sirius Shareholders at the meeting of Sirius Shareholders described in Section 6.6, those holders of Sirius Options who elect to exercise their options, respectively, with or without cash, in exchange for the right to participate in the Transaction prior to Closing. 1.85 "Party" and "Parties" has the meaning defined in the opening paragraph of this Agreement. 1.86 "Patents" means the patents and patent applications in any country in the world, together with any patents that may issue therefrom in any country in the world, including any and all extensions, renewals, continuations, continuations-in-part, divisions, patents-of-additions, reissues, supplementary protection certificates or foreign counterparts of any of the foregoing and any patents based on applications that claim priority from any of the foregoing; and a "Patent" shall be any one of the foregoing. 1.87 "Pension Plan" has the meaning defined in Section 3.13(a). 1.88 "Perrigo" means Perrigo Company, a Michigan company. 1.89 "Perrigo Agreement" means the Supply Agreement, dated October 21, 2005, by and between Perrigo and Sirius. 1.90 "Person" means any individual, corporation (including any non-profit corporation), general or limited partnership, limited liability partnership, limited liability company, joint venture, estate, trust, association, organization, labor union, Governmental Body or other entity. 1.91 "Plan" has the meaning defined in Section 3.13(a). 1.92 "Plan of Merger" has the meaning defined in the Recitals to this Agreement. 1.93 "Principal Shareholders" means those shareholders of Sirius whose names are set forth on the signature pages attached to this Agreement, who are the holders of greater than eighty-eight percent (88%) of the issued and outstanding Sirius Shares as of the date of this Agreement. 8 1.94 "Proceeding" means any action, arbitration, audit, hearing, investigation, litigation, inquiry or suit (whether civil, criminal, administrative or investigative) commenced, brought, conducted, or heard by or before, or otherwise involving, any Governmental Body or arbitrator. 1.95 "Products" means those products of Sirius set forth on Schedule 1.95 to this Agreement. 1.96 "Qualified Plan" has the meaning defined in Section 3.13(a). 1.97 "Regulation D" has the meaning defined in the Securities Act. 1.98 "Representation and Warranties Insurance" has the meaning defined in Section 9.7. 1.99 "Representative" means with respect to a particular Person, any director, officer, employee, agent, consultant, advisor, or other representative of such Person, including legal counsel, accountants, and financial advisors. 1.100 "Restricted Payment" means any acceleration or increase by Sirius of any salaries, or any acceleration, payment or increase by Sirius of any bonuses or other compensation, severance or similar payments to any service provider, shareholder, director or officer since the Interim Balance Sheet, except for any payment or prepayment of any Sirius Debt Obligations or payments made in the ordinary course of business; provided, however, Restricted Payments shall not include Sirius's 2005 Management Bonus Program attached hereto as Schedule 1.100, or payment of Expenses as contemplated herein. 1.101 "SEC" means the United States Securities and Exchange Commission. 1.102 "Securities Act" means the Securities Act of 1933, as amended from time to time, and the rules and regulations promulgated thereunder. 1.103 "Shareholder Representatives" has the meaning defined in Section 6.4. 1.104 "Shareholders Escrow Agent" shall have the meaning defined in Section 2.9(a). 1.105 "Shareholders Escrow Agreement" shall have the meaning defined in Section 2.9(a). 1.106 "Sirius" has the meaning defined in the opening paragraph of this Agreement. 1.107 "Sirius Debt Obligations" means, as of a particular date, the following obligations of Sirius: Sirius's Expenses other than the Sirius Transaction Expenses, and up to One Million Dollars ($1,000,000) of outstanding liabilities with respect to The PrivateBank and Trust Company Obligation, subject to the terms and conditions set forth in Section 2.4(a)(vii). 9 1.108 "Sirius Facility" means any offices, land or other facilities now or formerly owned, operated, leased, managed, used, controlled or occupied by or on behalf of Sirius in connection with Sirius's business or any predecessor-in-interest of Sirius. 1.109 "Sirius Options" has the meaning defined in Section 3.3(b). 1.110 "Sirius Shareholders" means all shareholders of Sirius on a fully diluted, as converted to common stock, basis. 1.111 "Sirius Shares" means the shares of common stock, $.01 par value per share, of Sirius. 1.112 "Sirius Transaction Expenses" has the meaning defined in Section 6.3(a)(ii). 1.113 "Tax" and "Taxes" means any federal, state, local or foreign income, gross receipts, franchise, excise, transfer, severance, value added, ad valorem, sales, use, wage, payroll, workmen's compensation, employment, occupation, estimated, withholding, social security, unemployment, disability, and real and personal property taxes; taxes measured by or imposed on capital; levies, imports, duties, license and legislation fees; and any other tax of any kind whatsoever imposed by any Governmental Body, including assessments in the nature of taxes; interest, penalties, fines, assessments and deficiencies relating to any tax or taxes; any transferee or secondary liability for taxes and any taxes due as a result of being a member of any affiliated, consolidated, combined or unitary group or any liability in respect of taxes under a tax sharing, tax allocation, tax indemnity or other agreement. 1.114 "Tax Return" means any return (including any information return), report, statement, schedule, notice, form, or other document or information filed with or submitted to, or required to be filed with or submitted to, any Governmental Body in connection with the determination, assessment, collection, or payment of any Tax or in connection with the administration, implementation, or enforcement of or compliance with any Legal Requirement relating to any Tax. 1.115 "The PrivateBank and Trust Company Obligations" means all indebtedness and obligations owed by Sirius to The PrivateBank and Trust Company under (a) that certain Business Loan Agreement, dated August 1, 2005, between Sirius and The PrivateBank and Trust Company; and (b) that certain Promissory Note, dated August 1, 2005, in the principal amount of $2,000,000, payable by Sirius to the order of The PrivateBank and Trust Company. 1.116 "Third Party" means any Person other than DUSA, Sirius and the Principal Shareholders. 1.117 "Third Party Manufacturer" has the meaning defined in Section 3.14(c)(iv). 1.118 "Title IV Plans" has the meaning defined in Section 3.13(a). 1.119 "Transaction" has the meaning defined in the Recitals of this Agreement. 10 ARTICLE II MERGER; CLOSING 2.1 MERGER. Subject to the terms and conditions of this Agreement and the Plan of Merger, at the Closing, Sirius shall merge with and into DUSA Sub and the Sirius Shareholders shall receive the Consideration set forth below. 2.2 CONSIDERATION. The aggregate consideration paid to the Sirius Shareholders shall be up to Thirty Million Dollars ($30,000,000), which amount shall be adjusted as provided for herein (the "Consideration"). The Consideration shall be paid as follows: (a) Eight Million Dollars ($8,000,000) in cash, less (i) the Sirius Transaction Expenses, which shall be paid at Closing as provided in Section 6.3, (ii) the Expense Escrow Amount, which shall be paid at Closing as provided in Sections 2.2(f) and 2.9(b), and (iii) the Dissenters Escrow Amount, which shall be paid to the Shareholders Escrow Agent at Closing, as provided in Section 2.9(a), shall be paid on a pro rata basis within five (5) Business Days following the Closing Date (or such shorter time period as may be reasonably practicable with respect to any Participating Shareholder who provides valid wire transfer instructions for such payments to DUSA in advance of the Closing) directly to the Participating Shareholders in accordance with their respective ownership percentages of the Sirius Shares set forth in Schedule 3.3(a), as shall be confirmed as of the Closing Date. (b) Subject to Section 2.5, a number of DUSA Shares having a Fair Market Value of Seventeen Million Dollars ($17,000,000) as of the date of the official public announcement of the Transaction shall be paid on a pro rata basis on the Closing Date directly to the Participating Shareholders, in accordance with their respective ownership percentages of the Sirius Shares set forth in Schedule 3.3(a). (c) An aggregate amount of up to Five Million Dollars ($5,000,000) shall be paid when due following the Closing to the Participating Shareholders on a pro rata basis with respect to the following milestone events that are achieved prior to the date that is forty-two (42) months from the Closing Date: (i) One Million Five Hundred Thousand Dollars ($1,500,000) in cash will be paid on a pro rata basis to the Sirius Shareholders in Five Hundred Thousand Dollar ($500,000) increments within ten (10) Business Days of each of the following milestone events (in each case subject to Section 10.4): (A) the marketing launch of New Product No. 1 as set forth on Schedule 1.80 being developed pursuant to the Perrigo Agreement, which does not require FDA pre-marketing approval; (B) the receipt of FDA pre-marketing approval of New Product No. 2 as set forth on Schedule 1.80 being developed pursuant to the Altana Agreement, which requires FDA approval; and (C) the marketing launch of any other New Product (i.e., other than those identified with respect to the Milestone Payments triggered by clause (A) or (B)), to be selected as provided in Section 10.4 below, whether or not FDA approval is required for such New Product. (ii) Three Million Five Hundred Thousand Dollars ($3,500,000) to be paid, in cash or DUSA Shares, as determined by DUSA in its sole discretion, within ten (10) 11 Business Days following the month in which a respective milestone is satisfied, if at all, of each of the following milestone events (in each case subject to Section 10.4): (A) One Million Five Hundred Thousand Dollars ($1,500,000) when cumulative Net Sales of the Products and the New Products reach Twenty Five Million Dollars ($25,000,000); (B) One Million Dollars ($1,000,000) when cumulative Net Sales of the Products and the New Products reach Thirty Five Million Dollars ($35,000,000); and (C) One Million Dollars ($1,000,000) when cumulative Net Sales of the Products and the New Products reach Forty Five Million Dollars ($45,000,000). In the event DUSA chooses to make any or all such Milestone Payments in DUSA Shares, such DUSA Shares shall have a Fair Market Value as close as is reasonably possible to the amount of the Milestone Payment after taking into account that no fractional DUSA Shares shall be issued in accordance with Section 2.2(e). (d) No interest shall accrue on any Milestone Payments, if any, to be paid, hereunder; provided such Milestone Payments are timely made in accordance with the terms of this Agreement. Interest on Milestone Payments not timely made in accordance with the terms hereof will accrue at an annual rate equal to the prime rate published in the Wall Street Journal (or a successor publication in the event the Wall Street Journal is no longer available) on the applicable due date of the late payment, plus five percent (5%). DUSA's obligation to pay each Milestone Payment, respectively, shall terminate if the aforementioned approvals, launches or cumulative Net Sales target amounts applicable to such Milestone Payments are not achieved by the Milestone Termination Date; provided, however, that, in the event of any sale, merger, dissolution, liquidation, winding-up, change of control or similar transaction involving DUSA (any such event being referred to as a "DUSA Change of Control") prior to the Milestone Termination Date, each Milestone Payment not already due and payable hereunder shall become immediately due and payable upon the effective date of such transaction, (i) in an amount equal to fifty percent (50%) of the amount of such Milestone Payment specified herein, or (ii) if such transaction occurs on or after the second (2nd) anniversary of the Closing Date and the cumulative Net Sales with respect to the Products and the New Products equals or exceeds Twenty Million Dollars ($20,000,000) for the period beginning on the Closing Date through the effective dates of such transaction, in an amount equal to one hundred percent (100%) of the amount of such Milestone Payment specified herein. Upon payment in-full of such amount under subparagraph (d)(i) or (ii) above in connection with a DUSA Change of Control, neither DUSA nor its successors or assigns shall have any further obligation or liability with respect to any of the Milestone Payments hereunder. (e) No fractional DUSA Shares shall be issued in satisfaction of the Consideration. DUSA shall be entitled to pay cash for any pro rata DUSA Share that is less than one whole DUSA Share. (f) The Expense Escrow Amount, in immediately available funds, shall be delivered to the Expense Escrow Agent on the Closing Date and held on behalf of the Participating Shareholders as provided for in Section 2.9(b) below. The Expense Escrow Amount shall be used to pay, unless paid prior to or at Closing, the legal expenses of Sirius in connection with the Transaction (other than such amounts to be paid by DUSA pursuant to Section 6.3(a)(ii) of this Agreement), any payments due to Elorac as a result of a change of control of Sirius under the Elorac Agreement, the premiums in connection with the extended 12 reporting endorsement for each claims-made insurance policy as provided for in Section 3.18(d), and other Sirius Shareholder post-Closing expenses, all of which in the aggregate are estimated to be Six Hundred Fifty Thousand Dollars ($650,000), in accordance with the terms of this Agreement and the Expense Escrow Agreement. (g) The Dissenters Escrow Amount, in immediately available funds, shall be delivered to the Shareholders Escrow Agent on the Closing Date and held on behalf of the Dissenting Shareholders as provided for in Section 2.9(a) below. The Dissenters Escrow Amount shall be used to pay the Dissenting Shareholders in accordance with the terms of this Agreement and the Shareholders Escrow Agreement. 2.3 CLOSING. Subject to the satisfaction of all of the Closing conditions set forth in this Agreement, unless waived, the closing of the Transaction (the "Closing") will take place at the offices of Reed Smith LLP at 136 Main Street, Suite 250, Princeton, New Jersey 08543 at 10:00 a.m. (EST) (a) on or before February 7, 2006, or (b) on such later date as mutually agreed upon by Sirius and DUSA, but in no event later than the date which is six (6) months from the date of the execution of this Agreement. (the "Closing Date"). 2.4 CLOSING OBLIGATIONS. (a) On or prior to the Closing Date, the Principal Shareholders or Sirius, as appropriate, shall deliver or cause to be delivered to DUSA in a form satisfactory to DUSA and its counsel the following (the "Closing Deliverables"): (i) stock certificates representing all of the Sirius Shares being exchanged in connection with the Transaction, duly endorsed with signatures guaranteed (or accompanied by duly executed stock powers) for conversion to DUSA Shares; (ii) a certificate executed by Sirius to the effect that each of the representations and warranties of Sirius contained in this Agreement were true and correct when made and are true and correct as of the Closing Date; and that the Participating Shareholders hold ninety (90%) percent or more of the issued and outstanding shares of Sirius Stock on a fully diluted as converted to common stock basis on the Closing Date. (iii) a certificate executed by each Principal Shareholder holding in excess of five percent (5%) of the Sirius shares to the effect that each of the representations and warranties of the Principal Shareholders contained in this Agreement, were true and correct when made and are true and correct as of the Closing Date; (iv) a fully completed and executed subscription agreement, substantially in the form attached hereto as Exhibit A, from each Participating Shareholder; (v) a certificate as to the incumbency of officers; (vi) a legal opinion from counsel of Sirius in form and substance reasonably satisfactory to DUSA and its counsel; 13 (vii) written confirmation from The PrivateBank and Trust Company that the Transaction, and, if necessary, the assumption by DUSA of The PrivateBank and Trust Company Obligations, will not result in a default under The PrivateBank and Trust Company Obligations; (viii) written confirmation, in form and substance reasonably satisfactory to DUSA, that as of the Closing the aggregate outstanding amount of The PrivateBank and Trust Company Obligations does not exceed One Million Dollars ($1,000,000) and that such amount does not exceed the cost of the Inventory then held by Sirius. (ix) an executed counterpart of the Articles of Merger to be filed with the Secretary of State of Illinois and the Certificate of Merger to be filed with the Secretary of State of New Jersey; and (x) an executed Plan of Merger adopted by the responsible officers of Sirius and meeting the requirements of IRC Reg. 1.368-3. (xi) audited consolidated financial statements of Sirius for the years ended December 31, 2003, 2004 and 2005, respectively, that meet the requirements of Item 9.01 of Form 8-K and the applicable provisions of Regulation S-X. (b) On or prior to the Closing Date, DUSA shall, in a form satisfactory to Sirius and its counsel, deliver to: (i) the Participating Shareholders and the Escrow Agent, those portions of the Consideration due pursuant to Sections 2.2(a), 2.2(b), 2.2(f) and 2.2(g); (ii) Sirius, a certificate executed by DUSA to the effect that each of the representations and warranties of DUSA contained in this Agreement were true and correct when made and are true and correct as of the Closing Date; (iii) Sirius, an executed counterpart of the Articles of Merger to be filed with the Secretary of State of Illinois and the Certificate of Merger to be filed with the Secretary of State of New Jersey; (iv) Sirius, an executed Plan of Merger adopted by the responsible officers of DUSA and meeting the requirements of IRC Reg. 1.368-3. (v) Sirius, an Assignment and Assumption of Sirius Debt Obligations. (c) On or prior to the Closing Date, the Parties shall execute and deliver to each other the Liability Escrow Agreement, the Shareholders Escrow Agreement, the Registration Rights Agreement, any consulting agreements and all other agreements, certifications, and other documents, as necessary and appropriate. 14 2.5 LIABILITY ESCROW. (a) At the Closing, DUSA shall withhold a number of DUSA Shares having a Fair Market Value of Three Million Dollars ($3,000,000) (the "Liability Escrow Amount") from that portion of the Consideration to be issued pursuant to Section 2.2(b) and shall instead deliver the Liability Escrow Amount to American Stock Transfer and Trust Company, who shall act as escrow agent (the "Liability Escrow Agent"), for deposit into an escrow account (the "Liability Escrow Account"). The Liability Escrow Amount shall be withheld from the Consideration to be issued pursuant to Section 2.2(b) on a pro rata basis among all of the Participating Shareholders in proportion to the aggregate amount of the Consideration each such Participating Shareholder would otherwise be entitled to receive at Closing. The Liability Escrow Amount shall be held pursuant to the provisions of an escrow agreement (the "Liability Escrow Agreement"), substantially in the form attached as Exhibit B. (b) The Liability Escrow Amount will be available to satisfy the indemnification obligations of Sirius and the Sirius Shareholders hereunder pursuant to the terms of Article XIII to compensate DUSA for any Damages incurred by DUSA pursuant to (i) any undisclosed liabilities of Sirius arising prior to the Closing Date, (ii) subject to Section 2.5(f), a court order, temporary restraining order, permanent injunction, cease and desist letter or other notice containing a significant threat to the continued manufacturing, production and/or marketing of a Product with respect to any Third Party Intellectual Property Rights relating to any of the Products; provided, however, that for purposes of indemnification hereunder, the maximum portion of the Liability Escrow Amount available to satisfy any claim with respect to a Product pursuant to Section 2.5(b)(ii) shall be equal to the Liability Escrow Amount reduced on a Dollar for Dollar basis by the amount of the revenue recognized by DUSA or DUSA Sub from such Product referenced in this clause (ii) from and after the Closing, and, subject to Section 2.5(f) below, as of the date upon which DUSA retains litigation counsel to defend any claim in connection with this clause (ii) (the "Claim Date"), the amount of revenue recognized with respect to such Product following the Claim Date will be offset by the amount of Damages incurred by DUSA from and after the Claim Date, (iii) any Material breach of any representation, warranty or covenant made by Sirius or a Principal Shareholder made in this Agreement or otherwise in connection with the Transaction, (iv) any tort claim, including, but not limited to, negligence and strict liability claims, and claims for intentional misconduct or wrongdoing; and (v) any Taxes to the extent provided in Article XIV. The value per share of each of the DUSA Shares used to satisfy a claim, if any, shall equal the same value per share as calculated for purposes of Section 2.2(b). For purposes of clarity, this means that in the event a claim is made, the value per DUSA Share as calculated pursuant to Section 2.2(b) of this Agreement shall be used notwithstanding the fact that the fair market value of a share of the common stock of DUSA at the time of the claim may be lower or higher than the value calculated in accordance with Section 2.2(b) of this Agreement. (c) No claims may be offset against the Liability Escrow Amount after two (2) years following the Closing Date. In addition, notwithstanding anything herein to the contrary, DUSA may not make any claim against the Liability Escrow Amount and the Liability Escrow Agent shall not release any Liability Escrow Amount to DUSA unless and until any individual claim or group of like claims is equal to or exceeds the Floor and all cumulative claims exceed One Hundred Thousand Dollars ($100,000), and shall be otherwise subject to the 15 limits set forth in Article XIII hereof; provided, however, for purposes of determining whether any individual claim equals or exceeds the Floor, DUSA shall be permitted to aggregate "like claims" falling within the following specified categories: (i) contractual claims with respect to any and all contracts assumed by DUSA in connection with the Transaction, (ii) unpaid taxes and other governmental claims, (iii) tort claims, including, but not limited to, negligence and strict liability claims, and (iv) claims for intentional misconduct or wrongdoing. In consideration of the foregoing, all claims shall be considered to fall within one of the four categories specified above. In the event a claim could fit into 2 or more categories, it shall be applied in its entirety to the category that is most applicable. For purposes of clarity, individual claims each falling below the Floor shall be eligible to be offset against the Liability Escrow Amount if, when grouped together in the aforementioned categories, such claims in the aggregate equal or exceed the Floor and all claims cumulatively exceed One Hundred Thousand Dollars ($100,000). Further, once cumulative claims exceed One Hundred Thousand Dollars ($100,000), it will not be necessary for subsequent claims to again cumulatively exceed One Hundred Thousand Dollars ($100,000) so long as claims including aggregated "like claims" exceed the Floor as set forth above. (d) To the extent that there are any DUSA Shares remaining in the Liability Escrow Account which have not been reserved for asserted claims under the Liability Escrow Agreement on the date that is two (2) years after the Closing Date, such DUSA Shares will be released on a pro rata basis to the Participating Shareholders. (e) Notwithstanding the foregoing, upon the effective date of any DUSA Change of Control, the Liability Escrow Amount shall be immediately released from the Liability Escrow Account by the Liability Escrow Agent. DUSA shall be entitled to pay cash for any pro rata DUSA Share that is less than one whole DUSA Share and shall not issue any fractional shares as provided in Section 2.2(e). (f) DUSA shall notify the Shareholder Representatives of any matter described in Section 2.5(b)(ii) as promptly as practicable after DUSA obtains Knowledge thereof. DUSA shall consult with the Shareholder Representatives and shall take such Commercially Reasonable Efforts as may be appropriate, including, without limitation, entering into litigation with respect thereto after reasonably considering the circumstances with regard to such potential litigation, including, but not limited to, the cost to DUSA to enter into and maintain such litigation, the estimated time period necessary to successfully conclude such litigation, and the amount of the Liability Escrow Amount remaining available for indemnification purposes; provided, however, that DUSA shall not be required to spend any amount in excess of the available Liability Escrow Amount on any defense of its rights with respect to such Products. DUSA may only make a claim with respect to the Liability Escrow Amount under Section 2.5(b)(ii) in the event DUSA has, in its commercially reasonable discretion after consulting with the Shareholder Representatives, engaged litigation counsel directly in response thereto. 2.6 LOCK-UP. DUSA Shares to be issued as provided for in Section 2.2(b) to any Sirius Shareholder who owns directly or beneficially five percent (5%) or more of the issued and outstanding Sirius Shares shall be subject to a lock-up of the DUSA Shares (the "Escrowed Shares"). The Escrowed Shares shall be held in escrow by the Shareholders Escrow Agent in an 16 account separate from the Dissenters Escrow Account with fifty percent (50%) of such Escrowed Shares being released on the first anniversary of the Closing Date and the balance being released on the second anniversary of the Closing Date. In addition, each other Sirius Shareholder receiving DUSA Shares hereunder who also receives (as determined by Sirius in advance of the Closing) the estimated 2006 revenue and loss ranges for DUSA (following the consummation of the Transaction) shall agree to be subject to a lock-up of such DUSA Shares until the earlier of (i) the first anniversary of the Closing Date, or (ii) the date on which such estimated 2006 revenue and loss ranges for DUSA (following the consummation of the Transaction) is announced to the public by DUSA or such information is deemed by DUSA in its reasonable discretion (in which case it will so notify such locked-up Sirius Shareholders) no longer Material to the business and operations of DUSA and/or DUSA Sub. If either the first or second anniversary of the Closing Date shall not fall on a Business Day, the respective Escrowed Shares shall be released as provided for herein on the next succeeding Business Day. Notwithstanding the foregoing, upon the effective date of any DUSA Change of Control, the Escrowed Shares shall be released from the escrow account by the Shareholders Escrow Agent and all of the obligations of the Sirius Shareholders pursuant to this Section 2.6 shall immediately terminate and cease to be of further force or effect, subject to applicable securities laws. 2.7 REGISTRATION RIGHTS. At Closing, to the extent the Form S-4 has not been prepared in accordance with this Agreement, the Parties shall execute a Registration Rights Agreement, substantially in the form attached hereto as Exhibit C (the "Registration Rights Agreement"), pursuant to which DUSA shall provide certain registration rights with respect to the DUSA Shares under the Securities Act and applicable state securities laws which shall provide each Participating Shareholder with rights to have his, her or its DUSA Shares registered promptly after Closing as further provided in the Registration Rights Agreement. 2.8 ASSUMPTION OF SIRIUS LIABILITIES. Effective as of the Closing, DUSA shall assume all liabilities of Sirius as shown on Schedule 2.8 (to be updated by Sirius prior to the Closing to include all liabilities incurred in the ordinary course between the date hereof and the Closing Date),the outstanding liabilities shown on the Interim Balance Sheet and all Sirius Debt Obligations, except as otherwise specifically provided for herein; provided, however, that DUSA shall have the right in its reasonable discretion to reject any Restricted Payments or liabilities otherwise accruing outside of the ordinary course between the date hereof and the Closing Date. 2.9 SHAREHOLDERS AND EXPENSE ESCROW. (a) The Dissenters Escrow Amount shall be delivered to American Stock Transfer and Trust Company, who will act as escrow agent with respect to the Dissenters Escrow Amount (the "Shareholders Escrow Agent"), in immediately available funds on the Closing Date for deposit into a designated account (the "Dissenters Escrow Account"). The Dissenters Escrow Amount shall be held pursuant to the provisions of an escrow agreement (the "Shareholders Escrow Agreement"), substantially in the form attached hereto as Exhibit D, to be entered into at or prior to the Closing. (b) The Expense Escrow Amount shall be delivered to Chicago Title and Trust Company, who will act as escrow agent with respect to the Sirius Shareholders (the "Expense Escrow Agent"), in immediately available funds on the Closing Date for deposit into a 17 designated account (the "Expense Escrow Account"). The Expense Escrow Amount shall be held pursuant to the provisions of an escrow agreement (the "Expense Escrow Agreement"), substantially in the form attached hereto as Exhibit E, to be entered into at or prior to the Closing. ARTICLE III REPRESENTATIONS AND WARRANTIES REGARDING SIRIUS Sirius hereby represents and warrants to DUSA as follows: 3.1 ORGANIZATION AND GOOD STANDING. (a) Sirius is a corporation duly organized, validly existing, and in good standing under the laws of the State of Illinois, with full corporate power and authority to conduct its business as it is now being conducted and to own or use the properties and assets that it purports to own or use. Schedule 3.1(a) sets forth the current directors and executive officers of Sirius. Except as set forth on Schedule 3.1(a), Sirius is duly qualified and authorized to transact business as a foreign corporation and is in good standing under the laws of each jurisdiction where such qualification is required or where failure to be so qualified would not have a Material Adverse Effect on Sirius. To the extent reasonably practicable, Sirius shall have paid in advance of Closing any fees and penalties arising as a result of any such failure to qualify. (b) Sirius does not own any shares of capital stock or any interest in, or does not control, and is not controlled by, directly or indirectly, any other corporation, limited liability company, partnership, association, joint venture or other business entity. (c) Sirius has provided to DUSA true and correct copies of the Organizational Documents of Sirius, as currently in effect. 3.2 AUTHORITY; NO CONFLICT; CONSENTS. (a) This Agreement constitutes the legal, valid, and binding obligation of Sirius, enforceable against Sirius in accordance with its terms. Sirius has all corporate right, power and authority to execute and deliver this Agreement and the other documents to be executed in connection herewith and to perform its obligations under this Agreement and the documents to be executed in connection herewith. (b) Except as set forth in Schedule 3.2(b), the execution, delivery and performance of this Agreement will not (with or without notice or lapse of time): (i) contravene, conflict with, or result in a violation of (1) any provision of the Organizational Documents of Sirius, or (2) any resolution of Sirius adopted by its board of directors or shareholders; (ii) contravene, conflict with, or result in a violation of any of the terms or requirements of, or give any Governmental Body the right to revoke, withdraw, suspend, cancel, terminate, or modify, any Governmental Authorization that is held by Sirius; or 18 (iii) contravene, conflict with, or result in a violation or breach of any provision of, or give any Person the right to declare a default or exercise any remedy under, or to accelerate the maturity or performance of, or to cancel, terminate, or modify, any contract, to which Sirius is a party or by which Sirius may be bound. (c) Except as set forth in Schedule 3.2(c), Sirius is not, and will not be, required to give any notice to or obtain any Consent from any Person in connection with the execution, delivery or performance of this Agreement. 3.3 CAPITALIZATION. (a) The total authorized capital stock of Sirius consists of 25,000,000 shares of Common Stock, of which 20,737,079 are issued and outstanding and no shares are held in treasury. Sirius has no other authorized classes of capital stock. The Sirius Shares have been duly authorized and are validly issued and are fully paid and nonassessable and, except as set forth on Schedule 3.3(a), are not subject to preemptive rights created by statute, the Organizational Documents of Sirius or any Contract. Except as referenced in Schedule 3.3(a), there are no Contracts for the issuance, sale or transfer of any equity securities or other securities of Sirius. All of the issued and outstanding Sirius Shares are held of record by the Persons with the addresses of record and in the amounts and pro rata percentages set forth in Schedule 3.3(a). (b) Schedule 3.3(b) contains a list of (i) any and all equity incentive plans that are currently in effect, (ii) the total number of Sirius Shares authorized for issuance under each equity incentive plan, and (iii) the total number of Sirius Shares underlying issued and outstanding grants under each such equity incentive plan. Except for the transactions contemplated by this Agreement and except as otherwise set forth in Schedule 3.3(b), there are no options, warrants, calls, rights, exchangeable or convertible securities, commitments or agreements of any character, written or oral, to which Sirius is a party or by which it is bound obligating Sirius to (i) issue, deliver, sell, repurchase or redeem, or cause to be issued, delivered, sold, repurchased or redeemed, any securities, or (ii) grant, extend, accelerate the vesting of, change the price of, otherwise amend or enter into any such option, warrant, call, right, exchangeable or convertible securities, commitment or agreement. All issued and outstanding options (each, an "Sirius Option," and collectively, the "Sirius Options") to purchase equity securities have been offered, sold and delivered by Sirius in compliance with the applicable equity incentive plan and with applicable law, including federal and state securities laws. Schedule 3.3(b) sets forth for each outstanding Sirius Option, the name of the holder of such Sirius Option, the domicile address of such holder, the number of shares issuable upon the exercise of such Sirius Option, the exercise price of such Sirius Option, the vesting schedule for such Sirius Option, including the extent vested to date, and whether such Sirius Option is intended to qualify as an incentive stock option as defined in Section 422 of the IRC. Schedule 3.3(b) sets forth all outstanding Sirius Shares that constitute unvested restricted stock or that are otherwise subject to a repurchase or redemption right, indicating the name of the applicable shareholder, the vesting schedule (including any acceleration provisions with respect thereto), and the repurchase price payable by Sirius, if any. (c) Except for the transactions contemplated by this Agreement and except as otherwise set forth in Schedule 3.3(c), there are no shareholder agreements, investor rights 19 agreements, registration rights agreements, voting trusts or other agreements or understandings to which Sirius is a party or to which it is bound relating directly or indirectly to any capital stock of Sirius. (d) Schedule 3.3(d) contains a list of the beneficial ownership, including number of shares and percentage of ownership, of all stockholders and option holders of Sirius on a fully diluted basis, assuming the vesting in full of all shares underlying outstanding options. Schedule 3.3(d) shall also contain a list of those holders of Sirius Options who elect to exercise their options, respectively, with or without cash, in exchange for the right to participate in the Transaction prior to Closing, including the number of options held and the percentage ownership attributable to such holder, assuming such options were exercised on a cashless basis. 3.4 FINANCIAL STATEMENTS. Prior to the date hereof, Sirius shall have delivered to DUSA draft financial statements, attached hereto as Schedule 3.4 (the "Draft Financial Statements"), of: (a) audited consolidated balance sheets of Sirius as of December 31, 2004 and 2003, respectively, and the related audited consolidated statements of income, changes in shareholders' equity, and cash flow for each of the fiscal years then ended, together with the notes thereto (the December 31, 2004 consolidated balance sheet together with notes is referred to herein as the "Balance Sheet") and (b) an unaudited consolidated balance sheet of Sirius as of the latest calendar quarter ended prior to the date hereof (the "Interim Balance Sheet") and the related unaudited consolidated statements of income. Such consolidated financial statements and notes fairly present in all Material respects the financial condition and the results of operations, changes in shareholders' equity, and cash flow of Sirius as at the respective dates of and for the periods referred to in such consolidated financial statements, all in accordance with GAAP, subject, in the case of interim consolidated financial statements, to normal recurring year-end adjustments (including, but not limited to, normal year-end current and deferred income tax adjustments); the consolidated financial statements referred to in this Section 3.4 reflect the consistent application of GAAP throughout the periods involved, except as otherwise disclosed in the notes to such consolidated financial statements or in Schedule 3.4. As soon as is practicable, but in no event less than five (5) Business Days prior to the Closing, Sirius shall provide DUSA with the final, audited financial statements for the three years ended December 31, 2005, 2004 and 2003, respectively (the "Final Financial Statements") as well as reasonable access to the management, financial consultants and auditors of Sirius for purposes of verifying such Final Financial Statements. 3.5 BOOKS AND RECORDS. The books of account, minute books, stock record books, and other records of Sirius, all of which have been provided to DUSA for review and have been or at Closing will be delivered to DUSA, are complete and correct in all Material respects. 3.6 TITLE TO ASSETS; ENCUMBRANCES. Sirius owns, leases or licenses all buildings, machinery, equipment, Products, inventory, marketing materials, other tangible assets, Intellectual Property Rights and other intangible assets necessary or desirable for the conduct of the business of Sirius as presently conducted and as conducted since its incorporation, and a complete and accurate list of all such assets are included on Schedule 3.6. All assets reflected on Schedule 3.6 are owned, leased or licensed (as applicable) (i) free and clear of all Encumbrances, except for The PrivateBank and Trust Company Obligations, (ii) free from Material defects, (iii) 20 in good operating condition and repair, normal wear and tear excepted, and. (iv) suitable for the purposes for which each is presently used. 3.7 REVOLVING CREDIT AND OTHER DEBT. Other than The PrivateBank and Trust Company Obligations, Sirius has no other revolving line of credit, short-term or long-term capital leases or other long-term debt. 3.8 SUBSIDIARIES. Except as otherwise set forth on Schedule 3.8, Sirius has no subsidiaries, whether wholly or partially owned, nor has Sirius had any subsidiaries since its inception. 3.9 INTELLECTUAL PROPERTY MATTERS. (a) Schedule 3.9(a) sets forth an accurate and complete list of all Sirius Intellectual Property Rights, including, but not limited to, the following: (i) all patents and patent applications owned or filed by, or on behalf of, Sirius or used in the business or operations of Sirius, including the country of filing, owner, filing number, date of issue, expiration date and title; (ii) all registered trademarks and applications for registration of trademarks owned or filed by, or on behalf of, or used by Sirius, including country of filing, description of goods or services, registration or application number and date of issue; (iii) all registered copyrights and applications for registration of copyrights owned or filed by, or on behalf of, or used by Sirius, including country of filing, owner, filing number, date of issue and expiration date; (iv) all common law trademarks, service marks, trade names, slogans, trade dress and the like owned by Sirius or used in the business or operations of Sirius; (v) all license agreements pursuant to which Sirius has outstanding rights to any Intellectual Property Rights of others and all agreements, oral or written, pursuant to which Sirius is obligated to pay royalties to Third Parties with respect to such Intellectual Property Rights; and (vi) all license agreements, oral or written, pursuant to which Sirius has granted to any Person any outstanding right to any Intellectual Property Rights and all agreements, oral or written, pursuant to which Sirius is entitled to receive royalties from Third Parties with respect to such Intellectual Property Rights, including licenses or other rights in unpatented formulations, manufacturing methods and other know-how and proprietary information of Sirius. (b) Complete and accurate copies of all patents, trademarks, copyrights, applications and agreements referenced in subsection (a) above have been delivered to DUSA. Complete and accurate summaries of verbal agreements referenced in subsection (a) above have been delivered to DUSA. 21 (c) Except as otherwise set forth on Schedule 3.9(c): (i) all the Intellectual Property Rights, to the extent owned by or licensed to Sirius, are not subject to any pending or, to Sirius's Knowledge, threatened claim, judgment or dispute of any nature; (ii) Sirius has not: (A) consented to the use by another Person of Sirius's name, trademarks, trade names or service marks or a name that is substantially similar thereto; or (B) entered into any license, agreement, or granted any other permission by which Sirius has granted to any Third Party rights with respect to any of its Intellectual Property Rights; (iii) there are no conflicts with the asserted rights of others with respect to any of the Sirius Intellectual Property Rights; (iv) to Sirius's Knowledge, the conduct of Sirius's business as currently conducted, including the manufacture and sale of Sirius's Products and the provision of Sirius's services as such activities are currently conducted, does not infringe, misappropriate or violate the Intellectual Property Rights of any other Person; (v) Sirius has received no invitations or offers to license the Intellectual Property of any Third Party; (vi) Sirius has received no notification from any Third Party stating that it believes any act of Sirius infringes such Third Party's Intellectual Rights; and (vii) with respect to Sirius's trademarks, trade names and service marks used by Sirius in connection with its Products and services (A) all such marks are valid and enforceable and in compliance with all formal legal requirements, (B) no such mark has been or is currently involved in any opposition or cancellation proceeding in the United States Patent and Trademark Office or the corresponding trademark authority of any foreign jurisdiction, (C) there has been no prior use of any such mark by any Third Party which would confer upon such Third Party superior rights in such mark, and (D) Sirius has received no written notice or claim contesting Sirius's ownership of such marks or the validity or enforceability thereof. 3.10 RELATED PARTY TRANSACTIONS. Schedule 3.10 sets forth a description of all transactions since Sirius's inception between Sirius and a Person who was at the time a related party. For purposes of this Section 3.10, "related party" means any present or former officer, director or Affiliate of Sirius, any present or former beneficial holder of five percent (5%) or more of the Sirius Shares, and any member of the immediate family of the foregoing. 3.11 NO UNDISCLOSED LIABILITIES. Except as set forth in Schedule 3.11, Sirius has no liabilities or obligations of any nature arising outside of the ordinary course of business (whether absolute, accrued, contingent, or otherwise), except for The PrivateBank and Trust Company Obligations and the liabilities or obligations reflected or reserved against in the Interim Balance Sheet. 22 3.12 TAXES. (a) Except as set forth in Schedule 3.12(a), Sirius has filed all Tax Returns that it was required to file under applicable laws and regulations. To the extent reasonably practicable, Sirius shall have paid in advance of Closing any Taxes and fees, including interest, arising as a result of any such failure to file and any required restatements of previous filings. All such Tax Returns were correct and complete in all respects and were prepared in substantial compliance with all applicable laws and regulations. All Taxes due and owing by Sirius (whether or not shown on any Tax Return) have been paid. Sirius is not currently the beneficiary of any extension of time within which to file any Tax Return. No claim has ever been made by an authority in a jurisdiction where Sirius does not file Tax Returns that Sirius is or may be subject to taxation by that jurisdiction. There are no Liens for Taxes (other than Taxes not yet due and payable) upon any of the assets of Sirius. (b) Sirius has withheld and paid all Taxes required to have been withheld and paid in connection with any amounts paid or owing to any employee, director, independent contractor, creditor, stockholder, or other Third Party. (c) Neither the IRS nor any other Governmental Body has threatened or to Sirius' Knowledge otherwise intends to assess Sirius any additional Taxes for any period for which Tax Returns have been filed. No foreign, federal, state, or local tax audits or administrative or judicial Tax proceedings are pending or being conducted with respect to Sirius. Sirius has not received from the IRS or any other Governmental Body (including jurisdictions where Sirius has not filed Tax Returns) any (i) notice indicating an intent to open an audit or other review, (ii) request for information related to Tax matters, or (iii) notice of deficiency or proposed adjustment for any amount of Tax proposed, asserted, or assessed by any taxing authority against Sirius. Schedule 3.12(c) lists all federal, state, local, and foreign income Tax Returns filed with respect to Sirius for taxable periods ended on or after January 1, 2002, indicates those Tax Returns that have been audited, and indicates those Tax Returns that currently are the subject of audit. Sirius has delivered to DUSA correct and complete copies of all federal, state, local and foreign income Tax Returns, examination reports, and statements of deficiencies assessed against or agreed to by Sirius filed or received since January 1, 2002. (d) Sirius has not waived any statute of limitations in respect of Taxes or agreed to any extension of time with respect to a Tax assessment or deficiency. (e) Sirius has not filed a consent under IRC Section 341(f) concerning collapsible corporations. Sirius is not a party to any agreement, contract, arrangement or plan that has resulted or could result, separately or in the aggregate, in the payment of (i) any "excess parachute payment" within the meaning of IRC Section 280G (or any corresponding provision of state, local or foreign Tax law) and (ii) any amount that will not be fully deductible as a result of IRC Section 162(m) (or any corresponding provision of state, local or foreign Tax law). Sirius has not been a United States real property holding corporation within the meaning of IRC Section 897(c)(2) during the applicable period specified in IRC Section 897(c)(1)(A)(ii). Sirius has disclosed on its federal income Tax Returns all positions taken therein that could give rise to a substantial understatement of federal income Tax within the meaning of IRC Section 6662. Sirius is not a party to or bound by any Tax allocation or sharing agreement. Sirius (A) has not been a member of an 23 Affiliated Group filing a consolidated federal income Tax Return (other than a group the common parent of which was Sirius) or (B) has no liability for the Taxes of any Person (other than Sirius) under Reg. Section.1.1502-6 (or any similar provision of state, local, or foreign law), as a transferee or successor, by contract, or otherwise. (f) Except as set forth on Schedule 3.12(a) with respect to the returns that have not been filed as of the date hereof or that will be restated, the unpaid Taxes of Sirius (i) did not, as of the Interim Balance Sheet, exceed the reserve for Tax liability (rather than any reserve for deferred Taxes established to reflect timing differences between book and Tax income) set forth on the face of the Interim Balance Sheet (rather than in any notes thereto) and (ii) do not exceed that reserve as adjusted for the passage of time through the Closing Date in accordance with the past custom and practice of Sirius in filing their Tax Returns. Since the date of the Interim Balance Sheet, Sirius has not incurred any liability for Taxes arising from extraordinary gains or losses, as that term is used in GAAP, outside the ordinary course of business consistent with past custom and practice. (g) Sirius will not be required to include any item of income in, or exclude any item of deduction from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of any: (i) change in method of accounting for a taxable period ending on or prior to the Closing Date; (ii) "closing agreement" as described in IRC Section.7121 (or any corresponding or similar provision of state, local or foreign income Tax law) executed on or prior to the Closing Date; (iii) installment sale or open transaction disposition made on or prior to the Closing Date; or (iv) prepaid amount received on or prior to the Closing Date. (h) Sirius has not distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by IRC Section.355 or IRC Section.361. 3.13 EMPLOYEE BENEFITS. (a) As used in this Section 3.13, the following terms have the meanings set forth below: "ERISA Affiliate" means, with respect to Sirius, any other Person that, together with Sirius, would be treated as a single employer under IRC Section. 414 or Section 4001 of ERISA. "Multi-Employer Plan" has the meaning given in ERISA Section. 3(37)(A). "Other Benefit Obligations" means all obligations, arrangements, policies, programs, contracts, agreements, or practices, whether or not legally enforceable, which is or has 24 been maintained, contributed to, or required to be contributed to, by Sirius or any ERISA Affiliate to provide benefits or remuneration of any kind, other than salary, to Employees, other than obligations, arrangements, and practices that are Plans. Other Benefit Obligations include consulting agreements, sabbatical policies, severance payment policies which are not Plans, fringe benefits within the meaning of IRC Section 132, performance awards, stock or stock related awards. "Pension Plan" has the meaning given in ERISA Section 3(2)(A) other than a Multi-Employer Plan. "Plan" has the meaning given in ERISA Section 3(3) whether written or unwritten or otherwise, funded or unfunded, which is or has been maintained, contributed to, or required to be contributed to, by Sirius or any ERISA Affiliate for the benefit of any of their respective Employees. "Qualified Plan" means any Pension Plan that meets or purports to meet the requirements of IRC Section 401(a). "Title IV Plans" means all Pension Plans that are subject to Title IV of ERISA, 29 U.S.C. Section 1301 et seq., other than Multi-Employer Plans. (b) Schedule 3.13(b) contains a complete and accurate list of all Plans and Other Benefit Obligations. Neither Sirius nor any ERISA Affiliate has any plan or commitment to establish any new Plan or Other Benefit Obligation, to modify any Plan or Other Benefit Obligation (except to the extent required by law or to conform any such Plan or Other Benefit Obligation to the requirements of any applicable law, in each case as previously disclosed to DUSA in writing, or as required by this Agreement), or to adopt or enter into any Plan. Sirius has delivered or made available to DUSA a true and correct copy of the governing plan document (or a description, in the case of any unwritten Plan) for each Plan (including all amendments thereto), its summary plan description and the three (3) most recent Form 5500s with all schedules and attachments (if applicable), if the Plan is funded, the most recent annual and periodic accounting of Plan assets, all correspondence to or from any governmental agency relating to any Plan, the three (3) most recent plan years discrimination tests for each Plan, and any trust agreement, insurance contract or other document under which Plan assets are held and invested or benefits provided. Sirius has further delivered or made available to DUSA a written description of each Other Benefit Obligation, and a copy of any document furnished to participants which summarizes or describes each Other Benefit Obligation. Sirius and its ERISA Affiliates have performed in all respects all obligations required to be performed by them under, are not in default or violation of, and have no knowledge of any default or violation by any other party, to each Plan and Other Benefit Obligation, and each Plan and other Benefit Obligation complies in form and operation in all respects with the applicable requirements of ERISA, the IRC and other applicable Legal Requirements. Any Plan intended to be qualified under Section 401(a) of the IRC and each trust intended to qualify under Section 501(a) of the IRC incorporates or has been amended to incorporate all provisions required to comply with the Tax Reform Act of 1986 and subsequent legislation with respect to which the period for adopting complying amendments has expired. Neither Sirius nor any ERISA Affiliate has at any time through the date hereof sponsored, maintained, contributed to or been obligated to contribute to 25 any Title IV Plan or Multi-Employer Plan, or any "funded welfare plan" within the meaning of Section 419 of the IRC. Neither Sirius or, to the Knowledge of Sirius, any fiduciary with respect to any Plan has engaged in any nonexempt prohibited transaction under ERISA Section 406 or Section 407, or incurred any liability for breach of fiduciary duty or any other failure to comply with any Legal Requirement in connection with the administration or investment of assets of any Plan. No action, suit, proceeding, hearing, audit or investigation with respect to the administration or investment of assets of any Plan (other than routine claims for benefits) is pending or, to Sirius's Knowledge, threatened. Except as otherwise disclosed on Schedule 3.13(b), Sirius does not provide health or other welfare benefits for any Employee and is not obligated to provide health or welfare benefits to any active Employee, following such individual's retirement or other termination of service (other than "COBRA" continuation coverage required under ERISA Sections 601 et seq. and IRC Section 4980B or similar state law). Neither Sirius nor its ERISA Affiliate has incurred any liability for excise, income or other taxes or penalties with respect to a Plan (other than employment and/or tax withholding that has been properly paid or paid over to the applicable government agency), and no event has occurred and no circumstances exists which could give rise to such liability. All persons classified by Sirius or its ERISA Affiliates as independent contractors satisfy and have at all times satisfied the requirements of applicable law to be so classified. Sirius and its ERISA Affiliates have fully and accurately reported their compensation on IRS Form 1099 when required to do so, and Sirius and its ERISA Affiliates have no obligations to provide benefits with respect to such persons under the Plans or otherwise. Neither Sirius nor its ERISA Affiliates employ any "leased employees" as defined in Section 414(n) of the IRC. Except as otherwise disclosed on Schedule 3.13(b), Sirius has not declared or paid any bonus compensation in contemplation of the transaction contemplated by this Agreement. No payments under any Plan or Other Benefit Obligation, as any such Plan, program or arrangement may be amended prior to December 31, 2006, will result in adverse tax treatment to Sirius or its successor, or any of its or their employees, under IRC Section 409A. (c) Effect of Transaction. (i) Except as disclosed on Schedule 3.13(c), the execution of this Agreement and the consummation of the transactions contemplated hereby will not (either alone or upon the occurrence of any additional or subsequent events) constitute an event under any Plan, Other Benefit Obligation, trust or loan that will or may result in any payment (whether of severance pay or otherwise), acceleration, forgiveness of indebtedness, vesting, distribution, increase in benefits or obligation to fund benefits with respect to any present or former employee, director or consultant of Sirius or any ERISA Affiliate. (ii) No payment or benefit which will or may be made by Sirius or its ERISA Affiliates with respect to any Employee or any other "disqualified individual" (as defined in IRC Section 280G and the regulations thereunder) will be characterized as an "excess parachute payment," within the meaning of Section 280G of the IRC. (d) Sirius is in compliance in all respects with all applicable foreign, federal, state and local laws, rules and regulations respecting employment, employment practices, terms and conditions of employment and wages and hours, in each case, with respect to Employees. There are no pending, or, to Sirius's Knowledge, threatened or reasonably anticipated claims or actions against Sirius under any worker's compensation policy or long-term disability policy. 26 There is no direct or indirect liability with respect to any misclassification of any Person as an independent contractor rather than as an employee, or with respect to any employee leased from another employer. (e) There are no actions, suits, claims, labor disputes or grievances pending, or, to Sirius's Knowledge, threatened or reasonably anticipated relating to any labor, safety or discrimination matters involving any Employee, which, if adversely determined, would, individually or in the aggregate, result in any Material liability to Sirius. Sirius has not incurred any liability or obligation under the Worker Adjustment and Retraining Notification Act or any similar state or local law which remains unsatisfied. (f) Since its incorporation, Sirius has not been a general partner of any general partnership. 3.14 COMPLIANCE WITH LEGAL REQUIREMENTS; GOVERNMENTAL AUTHORIZATIONS. (a) Except as set forth in Schedule 3.14(a) or Schedule 3.19: (i) Other than with respect to matters covered by Section 3.14(c)(i), Sirius is in compliance in all Material respects with each Legal Requirement that is or was applicable to it or to the conduct or operation of its business or the ownership or use of any of its assets, including, but not limited to, the Products; (ii) to Sirius's Knowledge, no event has occurred or circumstance exists that (with or without notice or lapse of time) may constitute or result in a Material violation by Sirius of, or a Material failure on the part of Sirius to comply with, any Legal Requirement; and (iii) Sirius has not received any written notice or other communication from any Governmental Body regarding: (1) any actual or alleged violation of, or failure to comply with, any Legal Requirement, or (2) any actual or alleged, obligation on the part of Sirius to undertake, or to bear all or any portion of the cost of, any remedial action of any nature. (b) Schedule 3.14(b) and Schedule 3.19, taken together, contain a list that is complete and accurate in all Material respects of each Governmental Authorization that is held by Sirius or that otherwise relates to the business of, or to any of the assets owned or used by, Sirius, including, but not limited to, the Products. Each Governmental Authorization listed in Schedule 3.14(b) or Schedule 3.19 is valid and in full force and effect. Except as set forth in Schedule 3.14(b) or Schedule 3.19: (i) Sirius is in compliance in all Material respects with all of the terms and requirements of each Governmental Authorization identified or required to be identified in Schedule 3.14(b) or Schedule 3.19; (ii) No event has occurred or to Sirius's Knowledge no circumstance exists that may (with or without notice or lapse of time): (A) constitute or result in a violation of or a Material failure to comply with any term or requirement of any Governmental Authorization identified or required to be identified in Schedule 3.14(b) or Schedule 3.19, or (B) result in the 27 revocation, withdrawal, suspension, cancellation, or termination of, any Governmental Authorization identified or required to be identified in Schedule 3.14(b) or Schedule 3.19; (iii) Sirius has not received any written notice or other communication from any Governmental Body regarding: (1) any actual or alleged violation of or failure to comply with any term or requirement of any Governmental Authorization, or (2) any actual or threatened revocation, withdrawal, suspension, cancellation, termination of any Governmental Authorization; and (iv) all applications required to have been filed for the renewal of any Material Governmental Authorizations identified or required to be identified in Schedule 3.14(b) or Schedule 3.19 have been duly filed on a timely basis with the appropriate Governmental Bodies, and all other filings required to have been made with respect to such Governmental Authorizations have been duly made on a timely basis with the appropriate Governmental Bodies. (c) Except as set forth in Schedule 3.14(c): (i) as to each prescription and non-prescription Product of Sirius for which a new or abbreviated new drug application has been or is required to be approved by the FDA, which Product is described in Schedule 3.14(c), Sirius and all Persons undertaking activities covered by such an application, or which would be covered by such an application if approved, are in compliance in all Material respects with applicable provisions of the FDCA and all terms and conditions of any approved application, and where any Product is marketed without an approved application, it is marketed in such a manner that does not give rise to an FDA enforcement action pursuant to current FDA enforcement policies for products marketed without an approved application. (ii) Sirius has not filed any biological product license application pursuant to Section 351 of the Public Health Service Act, 42 U.S.C. 262, for any Product; (iii) Sirius is in compliance in all Material respects with all applicable registration and listing requirements set forth in 21 U.S.C. 360 and 21 C.F.R. Part 207; (iv) Sirius does not conduct any manufacturing operations. All manufacturing operations relating to the business of Sirius are conducted by third parties (each a "Third Party Manufacturer"). To Sirius's Knowledge, all operations conducted on Sirius's behalf by Third Party Manufacturers have been and are being conducted in compliance with the good manufacturing practice regulations set forth in 21 C.F.R. Parts 210 and 211. Sirius has not received any notice that, and has no Knowledge that, any manufacturing operations conducted on behalf of Sirius by Third Party Manufacturers have not been or are not being conducted in compliance with the good manufacturing practice regulations set forth in 21 C.F.R. Parts 210 and 211; (v) Sirius has not nor, to Sirius's Knowledge, have any of its officers, employees or agents acting on its behalf, made an untrue or fraudulent statement to the FDA, failed to disclose a fact required to be disclosed to the FDA, or committed an act, made a statement or failed to make a statement that could reasonably be expected to provide a basis for 28 the FDA to cause Sirius or DUSA subsequent to Closing, to withdraw any Product from the marketplace or invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" as set forth in 56 Fed. Reg. 46191 (September 10, 1991); (vi) Sirius has delivered to DUSA copies of any and all reports in its possession of inspectional observations, establishment inspection reports, untitled letters, warning letters and any other documents received by Sirius or, to Sirius's Knowledge any other Person with respect to the Products, from the FDA that indicate or suggest lack of compliance, in any Material respect, with the FDA regulatory requirements by any one of the above or any Third Party Manufacturer; (vii) Sirius has not received, nor to Sirius's Knowledge has any Third Party Manufacturer received, any written notice that the FDA has commenced, or threatened to initiate any action to withdraw its approval or request the recall of any Product, or commenced or threatened to initiate any action to enjoin production at any Sirius Facility or any facility at which a Third Party Manufacturer conducts manufacturing operations on behalf of Sirius; (viii) as to each article of drug or consumer Product manufactured and/or distributed by Sirius, which Products are described in Schedule 3.14(c), to Sirius's Knowledge such article is not adulterated or misbranded within the meaning of the FDCA, 21 U.S.C. 301 et seq. in any manner that will give rise to any regulatory enforcement action pursuant to current FDA enforcement policies; (ix) as to each Product referred to in Schedule 3.14(c), Sirius has included or caused to be included in the application for such Product, where required, the certification described in 21 U.S.C. 335a(k)(l) and the list described in 21 U.S.C. 335a(k)(2), and such certification and such list was in each case true and accurate when made and remained true and accurate thereafter; (x) neither Sirius nor its officers, directors, or employees, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. 335a(a) or authorized by 21 U.S.C. 335a(b); and (xi) as to each new or abbreviated new drug application submitted to but not approved by the FDA, and not withdrawn by Sirius or any applicant acting on its behalf as of the date of this Agreement, Sirius has complied in all Material respects with the applicable requirements of the FDCA, including without limitation, 21 C.F.R. Parts 312 and 314 and have provided all additional information and taken all additional action requested by the FDA in connection with the application. 3.15 LEGAL PROCEEDINGS. Except as set forth in Schedule 3.15, no Proceeding: (a) has been commenced by or against Sirius or any of the assets owned or used by Sirius; or (b) is, to Sirius's Knowledge, threatened or pending by or against Sirius or any of the Material assets, including, but not limited to, the Products, owned or used by Sirius; or 29 (c) challenges, or may have the effect of preventing, delaying, making illegal, or otherwise interfering with, the Transaction. 3.16 ABSENCE OF CERTAIN CHANGES AND EVENTS. Except as set forth in Schedule 3.16, since the most recent fiscal year end, there has not been any Material Adverse Change involving the business or the assets of Sirius. Without limiting the generality of the foregoing, since that date there has not been a Material Adverse Change involving any: (a) change in Sirius's authorized or issued capital stock (other than pursuant to any exercise of stock options); grant of any stock option or right to purchase shares of capital stock of Sirius other than Sirius Options disclosed to DUSA; issuance of any security convertible into such capital stock; grant of any registration rights; purchase, redemption, retirement, or other acquisition by Sirius of any shares of any such capital stock; (b) split, combination, or reclassification any shares of its capital stock; or declaration or payment of any dividend or other distribution (whether in cash, stock or property or any combination thereof) in respect of its capital stock; (c) amendment to the Organizational Documents of Sirius; (d) increase in the salaries, bonuses or other compensation to any shareholder, director, officer, or employee of Sirius outside the ordinary course of business or entry into any employment, severance, or similar Contract with any director, officer, or employee of Sirius outside the ordinary course of business; (e) grant of any severance or termination pay (cash, equity or otherwise) to any officer or employee except pursuant to written agreements outstanding, or policies existing, on the date hereof and as previously disclosed in writing to DUSA, or adopt any new severance plan, or amend or modify or alter in any respect any severance plan, agreement or arrangement existing on the date hereof (other than as may be required or necessary to comply with or ensure non-applicability of Section 409A of the IRC), or grant any equity-based compensation; (f) adoption or amendment of any employee benefit plan, policy or arrangement, or employee stock purchase or stock option plan (other than as may be required or necessary to comply with or ensure non-applicability of Section 409A of the IRC), or execution of any employment contract outside the ordinary course of business or collective bargaining agreement, payment of any special bonus or special remuneration (cash, equity or otherwise) to any director or employee, or increase in the salaries or wage rates or fringe benefits (cash, equity or otherwise) (including rights to severance or indemnification) of its directors, officers, employees or consultants outside the ordinary course of business; (g) waiver of any stock repurchase rights, acceleration, amendment or change in or to the period of exercisability of options, restricted stock or any other equity or similar incentive awards (including without limitation any long term incentive awards), or repricing of options granted under any employee, consultant, director or other stock plans (other than as may be required or necessary to comply with or ensure non-applicability of Section 409A of the IRC); 30 (h) damage to or destruction or loss of any asset or property of Sirius, whether or not covered by insurance; (i) sale, other than in the ordinary course of business, lease, or other disposition of any asset or property of Sirius or mortgage, pledge, or imposition of any lien or other encumbrance on any asset or property of Sirius; (j) change in the accounting methods used by Sirius; or (k) agreement, whether oral or written, by Sirius to do any of the foregoing. 3.17 MATERIAL CONTRACTS; NO DEFAULTS. (a) Schedule 3.17(a) contains a complete and accurate list, and Sirius has delivered or by Closing will deliver to DUSA true and complete copies, of the following Contracts (the "Material Contracts"): (i) each employment, consulting, services, severance, confidentiality, and non-compete agreement, contract or commitment; (ii) each Contract that involves performance of services or delivery of goods or materials by or to Sirius in an amount or value in excess of $25,000 during any twelve-month period prior to and/or following the date hereof; (iii) each lease, rental or occupancy agreement, license, installment and conditional sale agreement, and other Contract affecting the ownership of, leasing of, title to, use of, or any leasehold or other interest in, any real or personal property (except personal property leases and installment and/or conditional sales agreements having a value per item or aggregate payments of less than $25,000); (iv) each joint venture, partnership, and other similar Contract (however named) involving a sharing of profits, losses, costs, or liabilities by Sirius with any other Person; (v) each Contract containing covenants that restrict the business activity of Sirius or limit the freedom of Sirius to engage in any line of business or to compete with any Person; (vi) each power of attorney that is currently effective and outstanding; (vii) each Contract for capital expenditures in excess of $25,000; (viii) each agreement between Sirius and any of its Third-Party Manufacturers; (ix) each agreement between Sirius and any of its distributors; and 31 (x) each amendment, supplement, and modification (whether oral or written) in respect of any of the foregoing. (b) Except as set forth in Schedule 3.17(b): (i) no Principal Shareholder has or may acquire any rights under, and no Principal Shareholder has or may become subject to any obligation or liability under, any Contract that relates in any Material respect to the business of, or any of the assets owned or used by, Sirius; and (ii) to Sirius's Knowledge, no officer, director, agent, employee, consultant, or contractor of Sirius is bound by any Contract that purports to limit the ability of such officer, director, agent, employee, consultant, or contractor to: (1) engage in or continue any conduct, activity, or practice relating to the business of Sirius or DUSA; or (2) assign to Sirius or to any other Person any of Sirius' Intellectual Property Rights. (c) Except as set forth in Schedule 3.17(c), each Material Contract identified or required to be identified in Schedule 3.17(a) is in full force and effect and is valid and enforceable in accordance with its terms. (d) Except as set forth in Schedule 3.17(d): (i) Sirius is in compliance in all Material respects with all applicable terms and requirements of each Material Contract; (ii) to Sirius's Knowledge, each other Person that has any obligation or liability under any Material Contract is in compliance in all Material respects with all applicable terms and requirements of such Material Contract; (iii) to Sirius's Knowledge, no event has occurred or circumstance exists that (with or without notice or lapse of time) may contravene, conflict with, or result in a violation or breach of, or give Sirius or other Person the right to declare a default or exercise any remedy under, or to accelerate the maturity or performance of, or to cancel, terminate, or modify, any Material Contract; and (iv) Sirius has not given to or received from any other Person, at any time, any notice or other communication (whether oral or written) regarding any actual, alleged, possible, or potential violation or breach of, or default under, any Material Contract. 3.18 INSURANCE. (a) Sirius has delivered to DUSA: (i) true and complete copies of all policies of insurance to which Sirius is a party or under which Sirius, or any officer or director of Sirius, is or has been covered at any time within the two (2) years preceding the date of this Agreement; 32 (ii) true and complete copies of all pending applications for policies of insurance; and (iii) true and complete copies of all documentation pertaining to any claim(s) made by Sirius pursuant to all policies of insurance with respect to the two (2) year time period preceding the date of this Agreement. (b) Schedule 3.18(b) describes: (i) any self-insurance arrangement by or affecting Sirius, including any reserves established thereunder; (ii) any contract or arrangement, other than a policy of insurance, for the transfer or sharing of any risk by Sirius; and (iii) all obligations of Sirius to third parties with respect to insurance (including such obligations under leases and service agreements) and identifies the policy under which such coverage is provided. (c) Except as set forth on Schedule 3.18(c): (i) Sirius has not received: (1) any refusal of coverage or any notice that a defense will be afforded with reservation of rights, or (2) any notice of cancellation or any other indication that any insurance policy is no longer in full force or effect or will not be renewed or that the issuer of any policy is not willing or able to perform its obligations thereunder; (ii) Sirius has paid all premiums due (or has accrued for such on its financial statements), and has otherwise performed all of its obligations, under each policy to which Sirius is a party or that provides coverage to Sirius or any director thereof; (iii) Sirius has notified its insurance carriers of any and all claims or potential claims known to Sirius with regard to any event or omission which could give rise to coverage under any insurance policy now in effect. (d) Sirius shall purchase at Sirius's expense an extended reporting endorsement, or a "tail," for each claims-made insurance policy now in effect and identified on Schedule 3.18(d) to provide continued coverage for any event or omission which may have occurred during the policy period which could give rise to coverage under such policy. Sirius shall name DUSA as an additional insured with respect to each such extended reporting endorsement. (e) Sirius has no Knowledge of or has not received any notice, correspondence or other documentation indicating that any formulary has dropped coverage for any Product or that any insurance provider will no longer provide reimbursement in connection with the purchase of any Product currently being reimbursed. 33 3.19 ENVIRONMENTAL MATTERS. (a) As used in this Section 3.19, the following terms have the meanings set forth below: "Environmental Claim" means any written complaint, notice, claim, demand, action, suit or judicial, administrative or arbitral proceeding by any Person to Sirius asserting liability or potential liability (including without limitation, liability or potential liability for investigatory costs, cleanup costs, governmental response costs, natural resource damages, property damage, personal injury, fines or penalties) arising out of, relating to, based on or resulting from: (i) the presence, discharge, emission, release or threatened release of any Hazardous Materials at any Sirius Facilities, (ii) circumstances forming the basis of any violation or alleged violation of any Environmental Laws or Environmental Permits, or (iii) otherwise relating to obligations or liabilities under any Environmental Law. "Environmental Laws" means all applicable foreign, federal, state and local statutes, rules, regulations, ordinances, orders and decrees relating in any manner to pollution or protection of the environment, to the extent and in the form that such exist at the date hereof. "Environmental Permits" means all permits, licenses, registrations, exemptions and other governmental authorizations required under Environmental Laws for Sirius to conduct its operations as presently conducted. "Hazardous Materials" means all hazardous or toxic substances, wastes, materials or chemicals, petroleum and petroleum products, asbestos and asbestos-containing materials, polychlorinated byphenyls, urea formaldehyde, pollutants, contaminants and all other materials and substances, including but not limited to radiologically contaminated materials and infectious materials defined or regulated pursuant to any Environmental Laws or that could result in liability under any Environmental Laws. "Off-Site Facilities" shall mean any facilities used for the treatment, storage or disposal of any Hazardous Materials associated with or resulting from either Sirius business or generated at any Sirius Facilities. "Release" shall mean any intentional or unintentional release, discharge, spill, leaking, leaching, pumping, pouring, emitting, emptying, injection, disposal or dumping. (b) Set forth in attached Schedule 3.19(b) are all of the Sirius Facilities and Off-Site Facilities known to Sirius. Except as set forth in Schedule 3.19(b): (i) Sirius is and at all times has been in Material compliance with all applicable Environmental Laws, if any, and, to Sirius's Knowledge, there is no condition that is reasonably likely to prevent or Materially interfere with compliance by Sirius with Environmental Laws; (ii) Sirius possesses all Environmental Permits, if any, applicable to Sirius. Each Environmental Permit issued to Sirius is in full force and effect. Sirius is in Material compliance with all requirements, terms and provisions of the Environmental Permits 34 issued to it and has filed on a timely basis (and updated as required) all reports, notices, applications or other documents required to be filed pursuant to the Environmental Permits. Sirius has submitted to DUSA true and complete copies of all of the Environmental Permits issued to or held by Sirius which by their terms or by operation of law will expire or otherwise become ineffective on or before the Closing Date. Sirius shall take all necessary actions to have such Environmental Permits renewed or reissued to them prior to the Closing Date. As for those Environmental Permits which by their terms or by operation of law will not expire or otherwise become ineffective on or before the Closing Date, no modification, revocation, reissuance, alteration, transfer or amendment of such Environmental Permit, or any review by, or approval of, any Third Party of any Environmental Permit is required in connection with the execution or delivery of this Agreement or the consummation by Sirius of the transactions contemplated hereby or the operation of the business of Sirius on the date of the Closing; (iii) Sirius has neither received any Environmental Claim, nor, to the Knowledge of Sirius, has any Environmental Claim been threatened against Sirius; (iv) Sirius has not entered into, agreed to or is subject to any outstanding judgment, decree, order or consent arrangement with any Governmental Body under any Environmental Laws, including without limitation those relating to compliance with any Environmental Laws or to the investigation, response, removal or remediation of Hazardous Materials; (v) Sirius is not and has never been a small or large quantity generator of Hazardous Materials under any Environmental Law. (vi) To Sirius's Knowledge, no Hazardous Materials have been Released on any Sirius Facility, requiring government notification, investigation, response, removal or remedial activity under any Environmental Law or otherwise in violation of any Environmental Law. (vii) No Federal, state, local, or municipal governmental agency or authority has obtained or asserted an encumbrance or lien upon any Sirius Facility as a result of any Release, use or cleanup of any Hazardous Material for which either Sirius is legally responsible, nor has any such Release, use or remediation occurred which could result in the assertion or creation of such a lien or encumbrance. (viii) (A) There is not now nor has there ever been located at any Sirius Facility any areas or vessels used or intended for the treatment, storage or disposal of Hazardous Materials, including, but not limited to, drum storage areas, surface impoundments, incinerators, landfills, tanks, lagoons, ponds, waste piles or deep well injunction systems. (B) Sirius has not transported any Hazardous Materials for storage, treatment or disposal, or arranged for the transportation, storage, treatment or disposal of any Hazardous Materials by contract, agreement or otherwise, at or to any location including, without limitation, any Off-Site Facilities. (ix) Sirius has delivered to DUSA (or before Closing will deliver) all reports, records, tests, evaluations, governmental agency and Third Party correspondence, and 35 other documents in Sirius's possession and relating to Sirius's use, storage, treatment, transport and disposal of Hazardous Materials or the presence of any Hazardous Material at any Sirius Facility. 3.20 BROKERS OR FINDERS. Sirius has incurred no obligation or liability, contingent or otherwise, for brokerage or finders' fees or agents' commissions or other similar payment in connection with this Agreement. 3.21 ACCOUNTS RECEIVABLE. All Accounts Receivable of Sirius listed on Schedule 3.21, are reflected properly on its books and records, are valid receivables and are collectible in accordance with their terms at their recorded amounts, subject only to the reserve for bad debts set forth in the Interim Balance Sheet (rather than in any notes thereto) as adjusted for the passage of time through the Closing Date in accordance with the past custom and practice of Sirius. 3.22 INVENTORY. All Inventory, taken as a whole, is useable and saleable, except for obsolete items of below-standard quality, all of which have been or will be prior to Closing written off or written down to estimated net realizable value (or reserves have been established for such Inventory) in the books and records of Sirius. The Inventory is free from Material defects in materials and/or workmanship. The Inventory is not excessive in kind or amount, or slow moving, in light of Sirius's business. All Inventory reflected in the financial statements is valued at the lower of cost or market with cost determined by the first in first out accounting method. Since the most recent fiscal year end, there has not been a Material increase in the level of Inventory outside the ordinary course of business. 3.23 WARRANTIES. Except as set forth on Schedule 3.23, Sirius has not made any oral or written warranties to its customers with respect to the quality or absence of defects of its Products which are in force as of the date hereof or with respect to which claims are outstanding as of the date hereof. There are no Material claims pending, anticipated or, to Sirius's Knowledge, threatened against Sirius with respect to the quality of, or existence of defects in, such Products and, to the Knowledge of Sirius, there is no legitimate basis for any such claim. Sirius has made available to DUSA information in its possession which is accurate in all Material respects, regarding all Material returns of defective or expired Products (other than Products damaged in transit) during the period beginning February 9, 2000 and ending on the date hereof, and all credits and allowances for such defective or expired Products given or promised to customers during said period, and such information in each case accurately describes the cause which resulted in the return, allowance or credit. Sirius has not paid or been required to pay any direct, incidental or consequential damages to any Person in connection with any of such Products. 3.24 PRODUCT LIABILITY. Except as set forth in Schedule 3.24, Sirius has filed with its insurance carrier all notices of claims or potential claims with respect to any Product manufactured, licensed, produced, distributed or sold by or on behalf of Sirius. Except as provided in Schedule 3.24, Sirius has not received any notice or claim involving any Product manufactured, licensed, produced, distributed or sold by or on behalf of Sirius resulting from an alleged defect in design, manufacture, materials or workmanship, or any alleged failure to warn, or from any breach of implied warranties or representations; nor, to the Knowledge of Sirius, is 36 there any basis for any such notice or claim. Products sold by Sirius since February 9, 2000 (i) have been sold and marketed in compliance in all Material respects with all Applicable Laws and (ii) have been fit for the purposes for which they were intended to be used and conformed in all Material respects to any promises or affirmations of fact made by Sirius, or with the authorization or consent of Sirius, (x) on the containers or labels therefor or (y) in connection with their sale. Sirius has not received any statement, citation or decision by any Governmental Body that any Product is defective or fails to meet any standards promulgated by such Governmental Body. There have been no recalls ordered by any Governmental Body with respect to any Product. To Sirius's Knowledge, there is no (i) fact relating to any Product that may impose upon Sirius a duty to recall the same or to warn customers of a defect therein, or (ii) latent or overt design, manufacturing or other defect in any Product. Schedule 3.24 sets forth all of the express product warranty, repair and replacement policies and obligations, of Sirius relating to the Products manufactured or sold since February 9, 2000. To Sirius's Knowledge, there is no (i) fact relating to any Product that may impose upon Sirius any duty to recall such Product or duty to warn customers of any defect in such Product, or (ii) latent or overt defect in any Product sold by Sirius. All Products sold by Sirius contained adequate warnings presented in accordance with then Applicable Laws. 3.25 CUSTOMERS AND SUPPLIERS. All Material customers and suppliers of Sirius are set forth on Schedule 3.25. Except as set forth on Schedule 3.25, Sirius has not received any indication from any Material supplier and has no knowledge or reason to believe that any Material supplier will stop, or Materially decrease the rate of supplying materials, products or services to Sirius. Sirius has not received any indication from any Material customer to the effect that, and to the Knowledge of Sirius that, there is no reason to believe that such customer will stop, or Materially decrease the rate of, buying materials, products or services from Sirius. 3.26 PRODUCT TREATMENTS; PRODUCT RETURNS. Except as set forth on Schedule 3.26, Sirius has not offered any promotional allowance to any customer nor has Sirius or its agents provided any customer-specific packaging or value added services (other than displays) with respect to the Products of Sirius outside the ordinary course of business. Sirius has processed all Product returns or requests for returns of Product of which Sirius is aware. No customer of Sirius has refused to accept further shipments of Products of Sirius. Sirius does not have outstanding any authorization to any of its customers to destroy any Product in lieu of returning such Product to it. 3.27 COMPLETE COPIES OF MATERIALS. Sirius has delivered true and complete copies of each document (or detailed summaries of same) in its possession or under its control that has been requested by DUSA or its counsel, including all Contracts and other documents listed on the schedules attached to this Agreement. 3.28 DISCLOSURES. Sirius has received all information and materials requested by the board of directors of Sirius relating to the business, finances and operations of DUSA and materials relating to the offer and sale of the DUSA Shares. 3.29 PRINCIPAL SHAREHOLDERS. As of the date of this Agreement, the Principal Shareholders hold greater than eighty-eight percent (88%) of the issued and outstanding Sirius Shares. 37 3.30 REPRESENTATIONS COMPLETE. None of the representations or warranties made by Sirius (as modified by the schedules attached to this Agreement) in this Agreement, and none of the statements made in any exhibit, schedule or certificate furnished by Sirius pursuant to this Agreement contains any untrue statement of a Material fact or omits to state any Material fact necessary in order to make the statements contained herein or therein, in the light of the circumstances under which made, not misleading. ARTICLE IV REPRESENTATIONS AND WARRANTIES OF PRINCIPAL SHAREHOLDERS The Principal Shareholders represent and warrant to DUSA as follows: 4.1 LEGAL CAPACITY, ORGANIZATION AND GOOD STANDING. Principal Shareholder that is a natural Person has the legal capacity and all requisite power and authority to enter into this Agreement and to comply with the provisions hereof. Each Principal Shareholder that is not a natural Person, including any corporation, limited partnership, limited liability company, trust or other entity, is duly organized, validly existing and in good standing under the laws of the jurisdiction of such entity's incorporation or formation and has all requisite power and authority to enter into this Agreement and to comply with the provisions hereof. 4.2 AUTHORITY; NO CONFLICT. (a) This Agreement constitutes the legal, valid, and binding obligation of such Principal Shareholder, enforceable against such Principal Shareholder in accordance with its terms. Each Principal Shareholder has the absolute and unrestricted right, power, authority, and capacity to execute and deliver this Agreement and the other documents to be executed in connection herewith and to perform its obligations under this Agreement and the documents to be executed in connection herewith. (b) Except as set forth in Schedule 4.2(b), neither the execution and delivery of this Agreement by any Principal Shareholder nor the consummation or performance of the Transaction by a Principal Shareholder will give any Person the right to prevent, delay, or otherwise Materially interfere with any of the transactions contemplated by this Agreement pursuant to: (i) any provision of any Principal Shareholder's Organizational Documents, if applicable; (ii) any resolution or consent adopted by the board of directors or shareholders of any Principal Shareholder, if applicable; (iii) any Legal Requirement to which a Principal Shareholder may be subject; or (iv) any Material Contract to which a Principal Shareholder is a party or by which a Principal Shareholder may be bound. 38 (c) Except as set forth in Schedule 4.2(c), each Principal Shareholder is not, and will not be, required to give any notice to or obtain any Consent from any Person in connection with the execution, delivery or performance of this Agreement. 4.3 OWNERSHIP OF SHARES. Each Principal Shareholder is and will be on the Closing Date the record and beneficial owner and holder of the Sirius Shares set forth opposite his/her/its name in Schedule 3.3(a) as shall be confirmed as of the Closing Date, and amended as required to accurately reflect any and all exercises of Sirius Options between the date hereof and the Closing Date. 4.4 NO PUBLIC SALE OR DISTRIBUTION. Each Principal Shareholder is acquiring the DUSA Shares in the ordinary course of business for its own account and not with a view towards, or for resale in connection with, the public sale or distribution thereof, except pursuant to sales registered or exempted under the Securities Act, and such Principal Shareholder does not have a present arrangement to effect any distribution of the DUSA Shares to or through any person or entity; provided, however, that by making the representations herein, such Principal Shareholder does not agree to hold any of the DUSA Shares for any minimum or other specific term (unless such Principal Shareholder is subject to the lock up of his/her/its DUSA Shares under Section 2.6 above) and reserves the right to dispose of the DUSA Shares at any time in accordance with or pursuant to the Registration Rights Agreement. 4.5 RELIANCE ON EXEMPTIONS. Each Principal Shareholder understands that the DUSA Shares are being offered and sold in reliance on specific exemptions from the registration requirements of federal and state securities laws and that DUSA is relying upon the truth and accuracy of, and such Principal Shareholder's compliance with, the representations, warranties, agreements, acknowledgments and understandings of such Principal Shareholder set forth herein in order to determine the availability of such exemptions and the eligibility of DUSA to acquire the DUSA Shares. 4.6 INFORMATION. Each Principal Shareholder and his/her/its advisors, if any, have been furnished with all materials relating to the business, finances and operations of DUSA and materials relating to the offer and sale of the DUSA Shares which have been requested by such Principal Shareholder including, but not limited to: (i) the DUSA SEC Documents; (ii) DUSA's Annual Report to Shareholders, which includes DUSA's Annual Report on Form 10-K and audited financial statements for the year ended December 31, 2004, and (iii) DUSA's definitive proxy statement, delivered in connection with DUSA's 2005 Annual Meeting of Shareholders. Such Principal Shareholder and his/her/its advisors, if any, have been afforded the opportunity to ask questions of DUSA. Neither such inquiries nor any other due diligence investigations conducted by such Principal Shareholder or his/her/its advisors, if any, or his/her/its representatives shall modify, amend or affect such Principal Shareholder's right to rely on DUSA's representations and warranties contained herein. Such Principal Shareholder understands that his/her/its investment in the DUSA Shares involves a high degree of risk including, without limitation, the risks set forth in the SEC Documents under the captions "Risk Factors," "Factors Affecting Future Operating Results" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," and is able to afford a complete loss of such investment. Such Principal Shareholder has sought such accounting, legal and tax advice 39 as he/she/it has considered necessary to make an informed investment decision with respect to the acquisition of the DUSA Shares. 4.7 NO GOVERNMENTAL REVIEW. Such Principal Shareholder understands that no Governmental Body has passed on or made any recommendation or endorsement of the DUSA Shares or the fairness or suitability of the investment in the DUSA Shares nor have such authorities passed upon or endorsed the merits of the offering of the DUSA Shares. 4.8 TRANSFER OR RESALE. Such Principal Shareholder understands that except as provided in the Registration Rights Agreement: (i) the DUSA Shares have not been and are not being registered under the Securities Act or any state securities laws, and may not be offered for sale, sold, assigned or transferred unless (A) subsequently registered thereunder, (B) such Principal Shareholder shall have delivered to DUSA an opinion of counsel, in a form reasonably acceptable to DUSA, to the effect that such DUSA Shares to be sold, assigned or transferred may be sold, assigned or transferred pursuant to an exemption from such registration; (ii) any sale of the DUSA Shares made in reliance on Rule 144 or Rule 144A promulgated under the Securities Act (collectively, "Rule 144") may be made only in accordance with the terms of Rule 144 and further, if Rule 144 is not applicable, any resale of the DUSA Shares under circumstances in which DUSA may be deemed to be an underwriter (as that term is defined in the Securities Act) may require compliance with some other exemption under the Securities Act or the rules and regulations of the SEC thereunder; and (iii) neither DUSA nor any other Person is under any obligation to register the DUSA Shares under the Securities Act or any state securities laws or to comply with the terms and conditions of any exemption thereunder (except as provided in the Registration Rights Agreement). 4.9 LEGENDS. Each Principal Shareholder understands that the certificates or other instruments representing the DUSA Shares, until such time as the resale of the DUSA Shares have been registered under the Securities Act as contemplated by the Registration Rights Agreement or such legend is not otherwise required pursuant to applicable law, shall bear any legend as required by the "Blue Sky" laws of any state and a restrictive legend in substantially the following form (and a stop transfer order may be placed against transfer of such stock certificates): NEITHER THE ISSUANCE AND SALE OF THE SECURITIES REPRESENTED BY THIS CERTIFICATE NOR THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR APPLICABLE STATE SECURITIES LAWS. THE SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD, TRANSFERRED OR ASSIGNED (I) IN THE ABSENCE OF (A) AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR (B) AN OPINION OF COUNSEL, IN A FORM REASONABLY ACCEPTABLE TO THE COMPANY, THAT REGISTRATION IS NOT REQUIRED UNDER SAID ACT OR (II) UNLESS SOLD PURSUANT TO RULE 144 UNDER SAID ACT. 40 4.10 BROKERS OR FINDERS. No Principal Shareholder has incurred any obligation or liability, contingent or otherwise, for brokerage, finders' fees, agents' commissions or other similar payment(s) in connection with this Agreement. 4.11 REPRESENTATIONS COMPLETE. None of the representations or warranties made by the Principal Shareholders in this Agreement, and none of the statements made in any exhibit, schedule or certificate furnished by the Principal Shareholders pursuant to this Agreement, contain any untrue statement of a Material fact or omits to state any Material fact necessary in order to make the statements contained herein or therein, in the light of the circumstances under which made, not misleading. ARTICLE V REPRESENTATIONS AND WARRANTIES OF DUSA DUSA represents and warrants to Sirius and the Principal Shareholders as follows: 5.1 ORGANIZATION AND GOOD STANDING. DUSA is a corporation duly organized, validly existing, and in good standing under the laws of the State of New Jersey, with full corporate power and authority to conduct its business as it is now being conducted. DUSA is duly qualified and authorized to transact business as a foreign corporation and is in good standing under the laws of each jurisdiction where such qualification is required or where failure to be so qualified would not have a Material Adverse Effect on DUSA. 5.2 AUTHORITY; NO CONFLICT. (a) This Agreement constitutes the legal, valid, and binding obligation of DUSA, enforceable against DUSA in accordance with its terms. DUSA has all corporate right, power and authority to execute and deliver this Agreement and the other documents to be executed in connection herewith and to perform its obligations under this Agreement and the documents to be executed in connection herewith. (b) Neither the execution and delivery of this Agreement by DUSA, nor the consummation or performance of the Transaction by DUSA or DUSA Sub, when formed, will give any Person the right to prevent, delay, or otherwise Materially interfere with the Transaction pursuant to: (i) any provision of any applicable Organizational Documents; (ii) any resolution adopted by the board of directors or the shareholders of DUSA or DUSA Sub when formed; or (iii) any Material Contract to which DUSA is or DUSA Sub when formed will be a party or by which DUSA may be bound. Neither DUSA nor DUSA Sub, when formed, are required to obtain any Consent from any Person, except for consents from their respective Boards of Directors, in connection with the execution and delivery of this Agreement or the consummation or performance of any of the transactions contemplated in this Agreement. 41 (c) Except as contemplated by this Agreement or in the attachments hereto, neither DUSA not DUSA Sub, when formed, is not a party to any other agreement or understanding with any of the Sirius Shareholders, Sirius or any of Sirius's employees. 5.3 INVESTMENT INTENT. DUSA is acquiring the Sirius Shares for its own account and not with a view to their distribution within the meaning of Section 2(a)(11) of the Securities Act. 5.4 CERTAIN PROCEEDINGS. No Proceeding or action by any of DUSA's shareholders has been commenced against DUSA or DUSA Sub, when formed, that challenges, or may have the effect of preventing, delaying, making illegal, or otherwise interfering with the performance of this Agreement or the transactions contemplated herein. To DUSA's Knowledge, no such Proceeding or shareholder action has been threatened. 5.5 BROKERS OR FINDERS. None of DUSA or DUSA Sub, when formed, nor any of their respective officers and agents have incurred any obligation or liability, contingent or otherwise, for brokerage or finders' fees or agents' commissions or other similar payment in connection with this Agreement. 5.6 DUSA SUB. As of the Closing, DUSA Sub shall be a duly organized and validly existing corporation in good standing under the laws of the State of New Jersey with corporate power to own its property, carry on its business as being conducted as of the Closing, and consummate the transaction. Prior to Closing, DUSA Sub will have engaged only in the transactions contemplated under this Agreement, will have no Material liabilities, and will have incurred no obligations except in connection with its performance of the transactions provided for in this Agreement. 5.7 NO UNDISCLOSED LIABILITIES. Except as set forth in Exhibit F, the DUSA SEC Documents and/or as reflected in DUSA's most recent financial statements set forth therein, DUSA has no Material liabilities or obligations of any nature arising outside of the ordinary course of business (whether absolute, accrued, contingent, or otherwise). 5.8 REPRESENTATIONS COMPLETE. None of the statements made in any exhibit, schedule or certificate furnished by DUSA pursuant to this Agreement contains any untrue statement of a Material fact or omits to state any Material fact necessary in order to make the statements contained herein or therein, in the light of the circumstances under which made, not misleading. 5.9 COMPLIANCE WITH LEGAL REQUIREMENTS. DUSA is in Material compliance with each applicable requirement of the SEC, National Association of Securities Dealers, the Ontario Securities Commission and applicable state securities commissions. DUSA has not received any written notice or other communication from any Governmental Body regarding: (a) any actual or alleged Material violation of or Material failure to comply with any term or requirement of any Governmental Authorization where such violation or failure would cause a Material Adverse Change, or (b) any actual or threatened revocation, withdrawal, suspension, cancellation, termination of any Governmental Authorization. 5.10 SEC COMPLIANCE. Except as otherwise treated or requested to be treated as confidential pursuant to a confidential treatment application submitted to the SEC, DUSA has 42 made available to Sirius and the Sirius Shareholders (by public filing with the SEC or otherwise) a true and complete copy of each report, schedule, registration statement and definitive proxy statement filed by DUSA, with the SEC since January 1, 2004 (the "DUSA SEC Documents"), which are all of the documents required to have been filed by DUSA with the SEC since that date. As of their respective dates, the DUSA SEC Documents complied in all Material respects with the requirements of the Securities Act or the Exchange Act, as the case may be, and all rules and regulations of the SEC promulgated thereunder applicable to such DUSA SEC Documents and none of the DUSA SEC Documents contained any untrue statement of a Material fact or omitted to state a Material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, except to the extent such statements have been modified or superseded by later DUSA SEC Documents filed and publicly available prior to the date of this Agreement. DUSA has no outstanding and unresolved comments from the SEC with respect to the DUSA SEC Documents. The consolidated financial statements of DUSA included in the DUSA SEC Documents complied as to form in all Material respects with the applicable accounting requirements and the published rules and regulations of the SEC with respect thereto, and have been prepared in accordance with generally accepted accounting principals applied on a consistent basis during the periods involved (except as may be indicated in the notes thereto or, in the case of the unaudited statements, as permitted by Rule 10-01 of Regulation S-X under the Exchange Act) and fairly present, in accordance with the applicable requirements of generally accepted accounting principles and the applicable rules and regulations of the SEC (subject, in the case of unaudited statements, to normal, recurring adjustments, none of which are Material), the consolidated financial position of DUSA, as of their respective dates and the consolidated statements of income and the consolidated cash flows of DUSA for the periods presented therein. 5.11 NO CONTEMPLATED SALE OF DUSA. Except as contemplated by this Agreement, no transaction or series of transactions, including, without limitation, a merger, consolidation, share exchange, reorganization or recapitalization, is under consideration by the management or Board of Directors of DUSA, which transaction is likely to result in a change in the ownership of fifty percent (50%) or more of the outstanding capital stock of DUSA. ARTICLE VI ADDITIONAL AGREEMENTS 6.1 APPROVALS OF GOVERNMENTAL BODIES. Subject to the receipt of the Investor Questionnaires, DUSA will make all filings required by the SEC, National Association of Securities Dealers, the Ontario Securities Commission and applicable state securities commissions necessary to consummate the transactions contemplated by this Agreement as promptly as practicable after the date of this Agreement. Between the date of this Agreement and the Closing Date, DUSA will cooperate with Sirius and the Sirius Shareholders with respect to all filings that are required by Legal Requirements to be made in connection with the transactions contemplated herein. DUSA will cooperate with Sirius and the Sirius Shareholders and Sirius will exercise Commercially Reasonable Efforts to obtain all consents identified in Schedule 3.2(c) and Schedule 4.2(c). 43 6.2 TAX MATTERS. Sirius will file all Tax Returns related to periods ending on or prior to Closing consistent with past practice. DUSA will, or will cause Sirius to, file Sirius's Tax Returns for tax periods ending after the Closing Date. 6.3 EXPENSES. (a) Subject to provisions set forth herein, whether or not the transactions contemplated hereby are consummated, all fees and expenses incurred in connection with this Agreement and the transactions contemplated hereby, including all investment banking, legal, accounting, financial advisory, consulting and all other fees and expenses of third parties incurred by a Party in connection with the negotiation and effectuation of the terms and conditions of this Agreement and the transactions contemplated hereby ("Expenses"), shall be the obligation of the respective party incurring such fees and expenses; except as otherwise expressly provided herein, and provided that: (i) So long as the Closing occurs, DUSA shall bear full responsibility for (A) all costs and expenses of Sirius's accountants incurred in connection with the auditing of Sirius for the three prior fiscal years and the transactions contemplated hereby, and (B) the costs and expenses of the Representation and Warranties Insurance; and (ii) the Sirius Shareholders shall bear full responsibility for (A) the costs of maintaining the insurance policy described in Section 10.2 from the Closing Date until the date that is three (3) years after the Closing Date, as further provided in Section 10.2, (B) the legal fees and expenses of Sirius incurred in connection with this Agreement and the transactions contemplated hereby, including, but not limited to, the preparation of a Registration Statement on Form S-4 as provided in Section 6.8; provided, however, DUSA shall bear the first Twenty-five Thousand Dollars ($25,000) of the cost of such legal fees and expenses incurred by Sirius in connection with the preparation of a Registration Statement on Form S-4, (C) any payments due to Elorac as a result of a change of control of Sirius under the Elorac Agreement, (D) any severance payments to employees of Sirius provided for in any written agreement in existence prior to the Closing, unless such employee is hired as an employee or retained as a consultant of DUSA, DUSA Sub, Sirius or any Affiliate thereof following the Closing, and (E) any of the PrivateBank and Trust Company Obligations in excess of the Sirius Debt Obligations (collectively, the "Sirius Transaction Expenses"). (b) At least five (5) Business Days prior to the Closing Date, Sirius shall provide DUSA with a statement of the Expenses described in clauses 6.3(a)(i) and (ii) above and all other Expenses of Sirius to be incurred prior to the Closing, such statement showing detail of both the previously paid and currently unpaid Expenses of Sirius incurred in connection with this Agreement and the transactions contemplated hereby, as well as the Expenses that have been incurred or are expected to be incurred by Sirius in connection with this Agreement and the transactions contemplated hereby, all in form reasonably satisfactory to DUSA and certified as true and correct in all Material respects by Sirius's President. Sirius's Expenses, other than the Sirius Transaction Expenses, shall constitute Sirius Debt Obligations and be assumed by DUSA. 44 6.4 SIRIUS SHAREHOLDERS' REPRESENTATIVES. Pursuant to the Subscription Agreement the Sirius Shareholders shall have constituted and appointed Frank Pollard and Jeffrey Bernstein, either acting alone or together, to serve as their representative (collectively, "Shareholder Representatives") for and on behalf of all of the Sirius Shareholders, to give and receive notices and communications, waive Closing conditions, accept delivery of Closing documents, agree to negotiate, enter into settlements and compromises of, and comply with orders of courts with respect to such claims, to take all other actions on behalf of the Sirius Shareholders as is explicitly contemplated by this Agreement, the Liability Escrow Agreement, the Expense Escrow Agreement, the Shareholders Escrow Agreement and/or the Registration Rights Agreement and to take all actions necessary or appropriate in the judgment of the Shareholder Representatives for the accomplishment of the foregoing. No bond shall be required of the Shareholder Representatives, and the Shareholder Representatives shall receive no compensation for their services from the Expense Escrow Amount. Notices or communications to or from the Shareholders' Representatives shall constitute notice to or from each Sirius Shareholder. 6.5 SIRIUS INFORMATION STATEMENT. Subsequent to the execution of this Agreement, Sirius shall prepare an information or proxy statement (the "Information Statement") for the purpose of calling a special meeting of the Sirius Shareholders to obtain approval of this Agreement and the Transaction. The Parties shall reasonably cooperate with each other in the preparation of the Information Statement. DUSA shall provide all information reasonably requested by Sirius in connection with the preparation of the Information Statement, and agrees that the information provided by it for inclusion in such Information Statement and each amendment thereto, at the time of the delivery thereof to the Sirius Shareholders and at the time of the Sirius Shareholders' meeting, will not include an untrue statement of a Material fact or omit to state a Material fact required to be stated or necessary to make the statements therein, in light of the circumstances under which they are made, not misleading. Sirius shall provide DUSA with a reasonable opportunity to review and comment upon the Information Statement prior to the distribution thereof to the Sirius Shareholders. Sirius shall reasonably consider all comments made by DUSA with respect to the Information Statement and revise the Information Statement as Sirius may determine to be necessary or appropriate. 6.6 SIRIUS SHAREHOLDER MEETING. As promptly as practicable after distribution of the Information Statement, but in any event prior to the Closing Date, Sirius shall duly call, give notice of, convene and hold a special meeting of the Sirius Shareholders for the purpose of approving the Transaction and amending the option plans. 6.7 INVESTOR QUESTIONNAIRES. Sirius shall use all efforts reasonably necessary to timely receive the highest possible return of completed investor questionnaires from each Sirius Shareholder in connection with the issuance of the DUSA Shares required to be issued to such Participating Shareholders as Consideration hereunder (collectively, the "Investor Questionnaires"), indicating whether each such Participating Shareholder meets the status of an "accredited investor," as that term is defined pursuant to the Securities Act. Each Principal Shareholder agrees to provide to DUSA a completed Investor Questionnaire. 45 6.8 UNACCREDITED INVESTORS. The parties understand and acknowledge that pursuant to Regulation D of the Securities Act, there can be no more than thirty-five (35) unaccredited Participating Shareholders taking part in the Transaction if the DUSA Shares to be issued as Consideration hereunder are to be issued in a Regulation D private placement. As such, promptly upon the receipt of the Investor Questionnaires, DUSA shall determine in its reasonable, good faith business judgment, based upon the information provided in the Investor Questionnaires or otherwise available to DUSA, whether to proceed with a Regulation D offering in connection with the Transaction. If DUSA determines not to proceed with such a Regulation D offering, then DUSA shall promptly notify Sirius thereof and, at its sole option and expense, except with respect to Sirius' legal fees as provided for in Section 6.3(a)(ii), promptly prepare or cause to be prepared and submitted to the SEC a registration statement on Form S-4, in conformity with all applicable Legal Requirements, for the purpose of registering the DUSA Shares to be issued as Consideration hereunder (the "Form S-4"). Should DUSA decide to register the DUSA Shares on Form S-4, Sirius and the Sirius Shareholders (or the Shareholders Representatives) shall cooperate with DUSA in its preparation and filing of such Form S-4. DUSA shall use its Commercially Reasonable Efforts to cause such Form S-4 to become effective as soon as practicable thereafter, provided, however, that the limitation with respect to Material expenditures shall not apply. For purposes of determining the investor status of each Participating Shareholder, the Parties expressly acknowledge and agree that any Sirius Shareholder that does not provide adequate information in a timely fashion in his/her/its Investor Questionnaire or in a follow-up response to Sirius subsequent to returning such Investor Questionnaire, shall be deemed by DUSA to be unaccredited for purposes of this Agreement. 6.9 TRANSITION. Sirius and those Principal Shareholders who are also officers of Sirius shall cooperate from the date hereof and for a reasonable period of time following the Closing, to plan and effect the transition of Sirius' business to DUSA Sub and shall reasonably consult with DUSA and/or DUSA Sub in connection therewith. 6.10 DUE DILIGENCE. Sirius shall permit DUSA to continue its due diligence with respect to the matters contemplated herein through and until the Closing. DUSA shall have to its satisfaction completed its due diligence review in connection with the Transaction and all matters related thereto and shall have concluded that no documentation or other information discovered during such due diligence review affects DUSA's understanding of the business of Sirius, DUSA's ability to conduct the business of Sirius, or the structure or effect of the Transaction by or on DUSA as of the date of this Agreement. 6.11 MICANOL LICENSE AGREEMENT. At or prior to Closing, the 2006 Micanol License Agreement, substantially in the form attached hereto as Exhibit G, shall be executed. ARTICLE VII CONDITIONS PRECEDENT TO DUSA'S OBLIGATION TO CLOSE DUSA's obligation to proceed with the Closing is subject to the satisfaction, at or prior to the Closing, of each of the following conditions (any of which may be waived by DUSA, in whole or in part): 46 7.1 ACCURACY OF REPRESENTATIONS. Each of the representations and warranties of Sirius and the Sirius Shareholders, respectively, contained in this Agreement shall be true and correct when made and as of the Closing, with the same force and effect as if made as of the Closing (except where the failure of a representation or warranty to be so true and correct would not reasonably be likely to have a Material Adverse Effect). DUSA shall have received certificates in accordance with Section 2.4 signed on behalf of Sirius by each of Sirius's chief executive officer and chief financial officer with respect to the foregoing. 7.2 COVENANTS. Each of the covenants contained in this Agreement to be complied with by Sirius and the Shareholders on or before the Closing shall have been complied with (except where the failure to do so would not reasonably be likely to have a Material Adverse Effect). 7.3 BOARD AND SHAREHOLDER APPROVAL. The Sirius Board of Directors and Sirius Shareholders, as necessary, shall have approved the Transaction and the terms and conditions of this Agreement. 7.4 CLOSING DELIVERABLES. Sirius and the Shareholders, as appropriate, shall have delivered the required Closing Deliverables to DUSA. 7.5 CONSENTS. Except as may be otherwise agreed to by Sirius and DUSA, each of the Consents identified in Schedule 3.2(c) and Schedule 4.2(c) must have been obtained and a copy of each such Consent identified in Schedule 3.2(c) and Schedule 4.2(c) provided to DUSA prior to the Closing. Each such Consent must be in full force and effect on and after the Closing Date, except where the failure to obtain such Consents were not due to a breach of DUSA of its obligation to cooperate to obtain such Consents under the standard outlined by the last sentence of Section 6.1. 7.6 NO PROCEEDINGS. Since the date of this Agreement, there must not have been threatened in writing or commenced against DUSA and/or Sirius, or against any Affiliate of Sirius, any Proceeding that, in the reasonable good faith judgment of DUSA, based on the advice of outside counsel, would (a) enjoin, restrain or otherwise prohibit the Transaction; (b) impose criminal penalties in connection with the consummation of the Transaction; or (c) impose a Material Adverse Effect, including, without limitation, preventing, delaying, making illegal, or otherwise interfering with the consummation of the Transaction. 7.7 TERMINATION OF SIRIUS EMPLOYEE PLANS. Subject to all of the current employees of Sirius who are to be employed by DUSA being fully covered by benefit plans maintained by DUSA effective as of the Closing (and not subject to any waiting periods), Sirius shall have provided DUSA with evidence, reasonably satisfactory to DUSA, as to the termination (to occur prior to or simultaneously with the Closing unless otherwise expressly agreed to by Sirius and DUSA with respect to a particular plan, program and/or arrangement) of Sirius plans, programs and arrangements referred to in Section 9.6. 7.8 FINANCIAL STATEMENTS. Sirius shall have delivered to DUSA, as soon as practicable, but in no event later than five (5) Business Days prior to the Closing Date, drafts of the Final Financial Statements and shall have provided DUSA with reasonable access to the 47 management, financial consultants and auditors of Sirius for the purpose of verifying such Final Financial Statements. There shall not have been a greater than five percent (5%) detrimental deviation between the 2003 Draft Financial Statements and the 2003 Final Financial Statements, the 2004 Draft Financial Statements and the 2004 Final Financial Statements, and the September 30, 2005 Sirius management financial statements and the 2005 Final Financial Statements, respectively, with respect to net sales and/or profit/loss with the exception of variances caused by adjustments related to revenue recognition, compensation expense, and reserves for returns and allowances. All financial statements shall be prepared in accordance with generally accepted accounting principals to the reasonable satisfaction of DUSA and its independent accountants. 7.9 MINIMUM PARTICIPATION. At Closing, DUSA must receive not less than ninety percent (90%) of the issued and outstanding Sirius Shares as of the Closing Date. Each Participating Shareholder must have returned to Sirius: (a) a fully executed Subscription Agreement, substantially in the form attached hereto as Exhibit A; (b) a completed and signed investor questionnaire previously distributed by Sirius; and (c) one or more stock certificates, with completed confirmed stock powers endorsed to DUSA, representing all of the Sirius Shares beneficially owned by the Sirius Shareholder. 7.10 FIRPTA AFFIDAVIT. Sirius shall deliver to DUSA an affidavit, under penalties of perjury stating that Sirius is not and has not been a United States real property corporation, dated as of the Closing Date, and in the form and substance required under Treasury Regulation 1.897-2(h) so that DUSA is exempt from withholding any portion of the Consideration thereunder (the "FIRPTA Affidavit"). 7.11 NON-COMPETITION. DUSA shall have entered into non-competition agreements with Frank R. Pollard and Joel Bernstein, M.D. in the applicable form of Exhibits H1 and H2, respectively, hereto. 7.12 ACCESS TO MANUFACTURING AND DISTRIBUTION FACILITIES. Promptly following the execution of this Agreement, Sirius shall obtain the necessary consents to enable representatives of DUSA to thoroughly inspect, prior to the Closing Date, any and all (i) Third Party Manufacturer facilities used by or on behalf of Sirius to manufacture one or more of the Products and (ii) distribution facilities used by or on behalf of Sirius to distribute one or more of the Products. As a condition to Closing, DUSA, in its reasonable discretion, must determine that the Third Party Manufacturer facilities and distribution facilities are in Material compliance with all applicable Legal Requirements and that the Third Party Manufacturer facilities have the reasonable capability of continuing to manufacture the Products in compliance with cGMP and all applicable laws. DUSA shall promptly notify Sirius in the event DUSA reasonably determines that such conditions may not be satisfied prior to Closing. 7.13 NO DROPPED COVERAGE. Prior to the Closing, Sirius shall not have become aware or received any notice, correspondence or other documentation indicating that any formulary has dropped coverage for any Product or that any insurance provider will no longer provide reimbursement in connection with the purchase of any Product currently being reimbursed such that such event has a Material Adverse Effect. Immediately upon receipt by Sirius of any such notice, correspondence or other documentation, Sirius shall provide a copy of same to DUSA. 48 7.14 EXTENDING REPORTING ENDORSEMENT. DUSA shall have received evidence of Sirius's purchase of an extended reporting endorsement, or a "tail," for each insurance policy as provided for in Section 3.18(d). 7.15 WAIVER OF RIGHT OF FIRST REFUSAL TO PURCHASE BIOGLAN SHARES. Provisions in Section 2, "Restrictions on Transfer," contained in the Stockholders' Agreement, dated December 1, 2000, by and among Bioglan, Sirius, Joel E. Bernstein, Jeffrey R. Bernstein and Frank R. Pollard, shall be waived by Sirius and the shareholders named therein. 7.16 KEY CONTRACTS. Sirius shall have caused the completion and execution of the following agreements and amendments to agreements: (a) Harmony Supply and Development Agreement. The Harmony Supply and Development Agreement shall be amended substantially in the form of the amendment attached hereto as Exhibit I, with such modifications as may be approved by DUSA, which approval shall not be unreasonably withheld, conditioned or delayed. (b) Amide Supply Agreement. The Amide Supply Agreement shall be amended substantially in the form of the amendment attached hereto as Exhibit J, with such modifications as may be approved by DUSA, which approval shall not be unreasonably withheld, conditioned or delayed. 7.17 ADVERSE EVENT REPORTING. Sirius shall complete all required filings with the FDA of MedWatch forms for adverse events and any other events discovered by DUSA or Sirius from the date hereof through the date of Closing pursuant to 21 C.F.R. Parts 312 and 314, and shall have notified its product liability insurance carriers of the occurrence of such events. 7.18 PRODUCT REGISTRATIONS. DUSA shall have determined to its reasonable satisfaction and in good faith that, from the date of this Agreement through the Closing Date, Sirius shall have completed all drug product registrations with the FDA and that Sirius has no reason to believe that the FDA will not accept such registrations for listing. 7.19 EFFECTIVE FORM S-4. If DUSA shall have decided to register the DUSA Shares to be issued as part of the Consideration on a Form S-4 as contemplated in Section 6.8, the Form S-4 shall have been declared effective by the SEC prior to the Closing Date. 7.20 QUALIFICATION FEES. To the extent reasonably practicable, Sirius shall have paid any fees and penalties arising as a result of any failure to qualify to transact business as a foreign corporation under the laws of each jurisdiction where such qualification is or was required by Sirius, as disclosed in Schedule 3.1(a). 7.21 SCHEDULES. The Schedules attached to this Agreement shall be complete at or prior to Closing to the reasonable satisfaction of DUSA. 7.22 DISCLOSURES. Sirius shall have provided all information and materials in Sirius's possession reasonably requested in writing by DUSA prior to the Closing Date. 49 ARTICLE VIII CONDITIONS PRECEDENT TO SHAREHOLDERS AND SIRIUS'S OBLIGATION TO CLOSE Sirius's and the Principal Shareholders' obligation to proceed with the Closing is subject to the satisfaction, at or prior of the Closing, of each of the following conditions (any of which may be waived by the Shareholder Representatives, in whole or in part): 8.1 ACCURACY OF REPRESENTATIONS. Each of the representations and warranties of DUSA contained in this Agreement shall be true and correct when made and as of the Closing, with the same force and effect as if made as of the Closing (except where the failure of a representation or warranty to be so true and correct would not reasonably be deemed to have a Material Adverse Effect). DUSA shall have delivered a certificate signed on behalf of DUSA by each of the chief executive officer and chief financial officer with respect to the foregoing to the Shareholder Representatives and Sirius. 8.2 COVENANTS. Each of the covenants contained in this Agreement to be complied with by DUSA on or before the Closing shall have been complied with (except where the failure to do so would not be reasonably likely to have a Material Adverse Effect). 8.3 BOARD APPROVAL. The Board of Directors of DUSA shall have approved the consummation of the Transaction and the terms and conditions of this Agreement. 8.4 CLOSING DELIVERABLES. DUSA shall have delivered the required Closing Deliverables to the Shareholders. 8.5 NO PROCEEDINGS. Since the date of this Agreement, there must not have been commenced against DUSA and/or Sirius, or against any Affiliate of Sirius, any Proceeding that, in the reasonable good faith judgment of Sirius, based on the advice of outside counsel, would (a) enjoin, restrain or otherwise prohibit the Transaction; (b) impose criminal penalties in connection with the consummation of the Transaction; or (c) impose a Material Adverse Effect, including, without limitation, preventing, delaying, making illegal, or otherwise interfering with the consummation of the Transaction. 8.6 DISCLOSURES. Sirius acknowledges that as of the date hereof, DUSA has provided to Sirius all information and materials which have been requested in writing by Sirius. Following the date of this Agreement and prior to the Closing Date, DUSA shall have provided all information and materials in DUSA's possession reasonably requested in writing by Sirius in order for Sirius to satisfy its delivery obligations to the Sirius Shareholders under Section 6.5 hereof. ARTICLE IX COVENANTS OF SIRIUS PRIOR TO CLOSING DATE 9.1 ACCESS AND INVESTIGATIONS. Between the date of this Agreement and the Closing Date, Sirius and its Representatives will cooperate with DUSA and, during normal business hours, will: (a) afford DUSA and its Representatives reasonable access to Sirius's personnel, properties, contracts, books and records, and other documents and data, (b) furnish DUSA and 50 DUSA's Representatives with copies of all such contracts, books and records, and other existing documents and data as DUSA may reasonably request, and (c) furnish DUSA and DUSA's Representatives with such additional financial, operating, and other data and information as DUSA may reasonably request. 9.2 OPERATION OF SIRIUS. Between the date of this Agreement and the Closing Date, Sirius will: (a) conduct the business of Sirius only in the ordinary course of business; (b) not amend any of its Organization Documents; (c) not issue any shares of its stock or rights to acquire shares of its stock, except with respect to preexisting obligations under the Sirius Options; (d) not make any Restricted Payment; (e) not enter into any Contract, or otherwise expense or distribute funds, that involve obligations of Sirius in an aggregate amount greater than $25,000 without the prior written approval of an officer of DUSA (other than as may be required or necessary to comply with or ensure non-applicability of Section 409A of the IRC); (f) not amend any Material Contract except as contemplated and disclosed to DUSA; (g) use Commercially Reasonable Efforts to maintain the goodwill of Sirius's customers, suppliers, distributors, employees, agents and consultants; and (h) file all appropriate MedWatch forms in consultation with DUSA with respect to any Product complaint or adverse event. 9.3 NEGATIVE COVENANT. Except as otherwise expressly permitted by this Agreement, between the date of this Agreement and the Closing Date, Sirius will not, without the prior written consent of DUSA, take any affirmative action, or fail to take any reasonable action within its control, as a result of which any of the changes or events listed in Section 3.14 is likely to occur. 9.4 REQUIRED APPROVALS. Sirius shall make all filings required by Legal Requirements to be made in order to consummate the transactions contemplated herein as promptly as practicable after the date of this Agreement and in any event prior to, in the case of filings required in the United States pursuant to such Legal Requirements, the tenth (10th) day following execution of this Agreement. Between the date of this Agreement and the Closing Date, Sirius will: (a) cooperate with DUSA with respect to all filings that DUSA elects to make or is required by Legal Requirements to make in connection with the transactions contemplated herein, and (b) cooperate with DUSA and will exercise Commercially Reasonable Efforts to obtain all consents identified in Schedule 3.2(c) and Schedule 4.2(c). 51 9.5 STANDSTILL. (a) From and after the date of this Agreement until the earlier to occur of the Closing or termination of this Agreement pursuant to Article XI, Sirius and the Principal Shareholders will not, and Sirius will not permit its Representatives to, directly or indirectly (a) initiate, solicit, encourage or entertain any inquiries, offers or proposals for any "Acquisition Proposal" (as defined below) by any Person (other than DUSA or its Representatives); (b) participate in any discussions or negotiations with, or disclose any non-public information not customarily disclosed consistent with Sirius's past practices concerning Sirius to, or afford access to the properties, books, or records of Sirius to, or otherwise assist or facilitate, or enter into any agreement or understanding with, any Person (other than DUSA and its Affiliates and Representatives) for the purpose of making, or take any other action to facilitate the making of, an Acquisition Proposal; (c) agree to approve or recommend any Acquisition Proposal; and/or (d) entertain or negotiate the sale of or offer to sell any shares of Sirius capital stock, whether or not presently issued. (b) For the purposes of this Agreement, "Acquisition Proposal" shall mean any one of the following (other than the Transactions contemplated hereunder) involving Sirius: (i) a proposal for any transaction pursuant to which a Third Party proposes to acquire beneficial ownership of at least ten percent (10%) of the outstanding equity securities of Sirius, whether from Sirius or pursuant to a tender offer, exchange offer, recapitalization, reorganization or otherwise, (ii) a proposal for any merger, consolidation or other business combination involving Sirius pursuant to which any Third Party proposes to acquire beneficial ownership of at least ten percent (10%) of the outstanding equity securities of Sirius, or the entity surviving such merger, consolidation or other business combination, (iii) a proposal for any other transaction or series of related transactions (including any license) pursuant to which any Third Party proposes to acquire control of the assets of Sirius, including, but not limited to, the Products, outside the normal course of Sirius' business as such business has been conducted prior to the date of this Agreement or which would otherwise have the effect of undermining the negotiations contemplated by this Agreement, or (iv) any public announcement of a proposal, plan or intention to do any of the foregoing or any agreement to engage in any of the foregoing. (c) The Principal Shareholders and Sirius will, and Sirius will cause its Representatives to, promptly cease any and all existing activities, discussions or negotiations with any parties conducted heretofore with respect to any Acquisition Proposal. (d) Notwithstanding the foregoing, no provision of this Section 9.5 shall be construed (i) to prohibit any of Sirius, the Principal Shareholders or their respective Representatives from responding to any proposal, inquiry or request for information in connection with an Acquisition Proposal or potential Acquisition Proposal for the sole purpose of advising the Person making such proposal, inquiry or request of Sirius' and the Principal Shareholders' obligations under this Section 9.5 or (ii) to require any of Sirius, the Principal Shareholders or their respective Representatives to disclose to DUSA any terms and conditions of any such proposal, inquiry or request, including the identity of the party making an Acquisition Proposal. 52 9.6 EMPLOYEE PLANS. Except as may otherwise expressly be agreed to by Sirius and DUSA and provided that all current employees of Sirius who are to be employed by DUSA following the Closing will be fully covered by benefit plans maintained by DUSA effective as of the Closing (and not subject to any waiting period), Sirius shall terminate, effective simultaneously with the Closing: (i) any and all group severance, separation or salary continuation plans, programs, or arrangements, and (ii) any and all other Plans (as defined in Section 3.13 of this Agreement), except with respect to such other plans as set forth on Schedule 9.6. DUSA shall receive from Sirius evidence that Sirius's Plan(s) and/or program(s), as applicable, have been terminated pursuant to resolutions of its Board of Directors (the form and substance of such resolutions shall be subject to review by and approval of DUSA), effective as of the Closing. Sirius shall also take such other actions in furtherance of terminating such Plans, policies and arrangements as DUSA may reasonably require. In the event that termination of a 401(k) plan is reasonably anticipated to trigger liquidation charges, surrender charges, or other fees to be imposed upon the account of any participant or beneficiary of such terminated plan or upon Sirius or the plan sponsor, then Sirius shall take such actions as are necessary to reasonably estimate the amount of such charges and/or fees and provide such estimate in writing to DUSA no later than fifteen (15) days prior to the Closing Date. 9.7 REPRESENTATION AND WARRANTY INSURANCE. Prior to Closing, DUSA shall determine in its discretion whether to negotiate and obtain a policy of representation and warranty insurance (the "Representation and Warranty Insurance") covering the representations and warranties made by Sirius and the Principal Shareholders pursuant to this Agreement. DUSA in its discretion shall approve the terms and conditions of any policy of Representation and Warranty Insurance obtained as provided for herein. Should DUSA decide to obtain a policy of Representation and Warranty Insurance, DUSA shall be fully responsible for all costs and expenses in connection therewith. Sirius and the Principal Shareholders shall reasonably cooperate and assist DUSA as necessary in obtaining such Representation and Warranty Insurance prior to Closing. ARTICLE X POST-CLOSING COVENANTS 10.1 SIRIUS BOARD NOMINEE. DUSA shall increase the size of its board of directors by one (1) director and shall cause Neal Penneys, M.D. (the "Board Nominee") to be appointed to fill such vacant board position until the date of the next applicable meeting of DUSA Shareholders. DUSA shall recommend that its Nominating and Corporate Governance Committee of the Board of Directors select the Board Nominee to be included as a nominee to serve as a member of the board of directors of DUSA on the slate of nominees to be voted upon at the next annual meeting of the DUSA shareholders following the Closing. DUSA's recommendation with respect to such nomination shall continue through the expiration of the period of time any Milestone Payment may be paid pursuant to the terms hereof, provided that during such period the Board Nominee (or such substitute board nominee as may be recommended by the Shareholder Representatives and selected by DUSA's Corporate Governance Committee should the Board Nominee become unable or unwilling to serve) qualifies to serve on DUSA's Board of Directors pursuant to its governance documents and applicable law. 53 10.2 MAINTENANCE OF SIRIUS D&O INSURANCE. DUSA shall, at the Sirius Shareholders expense, cause Sirius to maintain policies of director and officer liability insurance in amounts not less than Five Million Dollars ($5,000,000) covering the officers and directors of Sirius as of the date hereof until the later of (a) the date that is three (3) years after the Closing Date, or (b) the date after which the statutes of limitations for any claims that may be made thereunder have passed and all outstanding claims for liability with respect thereto have been finally resolved. The cost of maintaining the insurance coverage described in this Section 10.2 for a period of three (3) years shall, unless otherwise paid at the Closing, be paid by the Shareholders Escrow Agent from the Expense Escrow Amount, as soon as reasonably practicable following the Closing, and as otherwise provided in the Shareholders Escrow Agreement. 10.3 CONTINUITY OF SIRIUS BUSINESS. Following the Closing, for a period of at least twelve (12) months, DUSA shall continue Sirius's historic business and/or continue to use a significant portion of Sirius's historic assets in its ongoing business as provided for in this Agreement as necessary to satisfy the continuity of business enterprise requirements under Regulation 1.368-1(d) of the IRC. 10.4 PRODUCT DEVELOPMENT AND MARKETING REQUIREMENTS. (a) Promptly following the Closing, the Shareholder Representatives and DUSA shall each appoint one (1) representative to discuss product development and marketing activities relating to the Products and New Products as they determine. The initial appointees shall be Frank Pollard and Robert Doman, respectfully. The appointees shall consult with each other within six (6) months after the Closing Date with respect to the selection of the New Products to be used for purposes of determining the trigger for the applicable Milestone Payments pursuant to paragraph 2.2(c)(i). (b) Except as provided in Section 10.4(c), DUSA shall at all times prior to the Milestone Termination Date promote the Products and the New Products in accordance with the Minimum Marketing Standards. (c) If at any time DUSA determines, in its reasonable business judgment, that it is not commercially reasonable to initiate development, further develop or promote any New Product identified or selected with respect to any Milestone Payment pursuant to Section 2.2(c)(i) at the level required by the Minimum Marketing Standards, DUSA shall promptly notify Mr. Pollard of such determination and provide him with all relevant information regarding the reasons for such determination. Within thirty (30) days of such notification, Mr. Pollard shall consult with DUSA in its selection of an alternative New Product to be developed by DUSA for purposes of the Milestone Payments. DUSA shall promptly provide any information related to the marketing of any potential alternative New Products as Mr. Pollard may reasonably request. In the event DUSA declines to select an alternative New Product reasonably acceptable to Mr. Pollard within such thirty (30) day period, DUSA shall immediately be obligated to pay on a pro rata basis to the Sirius Shareholders Two Hundred Fifty Thousand Dollars ($250,000) in lieu of continuing the Minimum Marketing Standards with respect to the applicable New Product and all of its obligations with respect to the applicable Milestone Payment in such event shall, upon payment in full of such amount, be satisfied. In the event that Mr. Pollard becomes unable or 54 unwilling to serve in the capacity provided in this Section 10.4, the Shareholder Representatives may select another person to succeed Mr. Pollard in such role. ARTICLE XI TERMINATION 11.1 TERMINATION EVENTS. This Agreement may be terminated and the Transaction abandoned at any time prior to or at the Closing, whether before or after approval of the matters presented in connection with the Transaction by the Sirius Shareholders: (a) by either DUSA, or Sirius if a Material breach of any provision of this Agreement has been committed by the other Party and such breach has not been waived, provided that written notice has been given to the other Party of the intention to terminate under this Section 11.1(a) due to such breach and the other party has not cured such breach within thirty (30) days of receipt of such notice; (b) (i) by DUSA if any of the conditions in Article VII have not been satisfied as of the Closing Date or if satisfaction of such a condition is or becomes impossible (other than through the failure of DUSA to comply with its obligations under this Agreement) and DUSA has not waived such condition on or before the Closing Date; (ii) by Sirius or the Principal Shareholders, if any of the conditions in Article VIII have not been satisfied as of the Closing Date or if satisfaction of such a condition is or becomes impossible (other than through the failure of the Principal Shareholders to comply with their obligations under this Agreement) and the Principal Shareholders have not waived such condition on or before the Closing Date; provided that in each case written notice has been given to the other party of the intention to terminate under this Section 11.1(b) for failure to satisfy a specified condition and the other party has not cured such failure within thirty (30) days of receipt of such notice; (c) by either DUSA or Sirius if a Governmental Body of competent jurisdiction shall have issued an order, decree or ruling or taken any other action, in any case having the effect of permanently restraining, enjoining or otherwise prohibiting the Transactions; (d) by DUSA or Sirius upon the occurrence of a Material Adverse Effect to Sirius or DUSA; provided, however, that for purposes of this Section 11.1(d), Material Adverse Effect shall not include any effect or change solely related to the price per share of DUSA's common stock such as, without limitation, a general market or industry decline; (e) by DUSA should DUSA decide to obtain Representation and Warranty Insurance as provided for in Section 9.7 but such insurance is not reasonably satisfactory to DUSA in DUSA's reasonable determination prior to the Closing Date; (f) by DUSA, if Sirius shall fail to (i) recommend, or fails to continue its recommendation, that the Sirius Shareholders vote in favor of the adoption of this Agreement and the consummation of the Transaction; or (ii) hold a shareholders' meeting or otherwise 55 obtain the written consent of the Sirius Shareholders approving the adoption of this Agreement and the consummation of the Transaction; (g) by DUSA should the FDA notify Sirius of (i) any enforcement action with respect to the marketing of any Product; (ii) any recall, voluntary or otherwise, or (iii) any action which would undermine the ability of DUSA to conduct Sirius's business in the manner it is conducted as of the date of this Agreement and which result in a Material Adverse Effect; (h) by DUSA should, prior to the Closing, the price per share of DUSA common stock fall to a level which would require approval by the shareholders of DUSA prior to the issuance of any shares in satisfaction of the Consideration; (i) by DUSA after receipt of the written legal opinion of counsel detailing that terminating the Agreement is required in order for the Board of Directors of DUSA to comply with its fiduciary duties under the applicable laws of the State of New Jersey; (j) by mutual written consent of DUSA and Sirius; or (k) by either DUSA or Sirius if the Closing has not occurred (other than through the failure of the party seeking to terminate this Agreement to comply fully with its obligations under this Agreement) on or before (i) February 7, 2006, if the terminating party has satisfied all of its obligations hereunder and the non-terminating party has not satisfied all of its obligations hereunder, or (ii) in the event that the DUSA Shares to be issued hereunder are to be registered pursuant to a registration statement on Form S-4, as provided for in Section 6.8, the date which is six (6) months from the date of the execution of this Agreement. Notwithstanding 11.1(d), the Parties expressly agree that DUSA shall not have the right to terminate this Agreement as a result of a court order, temporary restraining order, cease and desist letter or other claim with respect to any Third Party Intellectual Property Rights. 11.2 EFFECT OF TERMINATION. Each Party's right of termination under Section 11.1 is in addition to any other rights it may have under this Agreement or otherwise, and the exercise of a right of termination will not be an election of remedies. If this Agreement is terminated pursuant to Section 11.1, all further obligations of the parties under this Agreement will terminate; provided that if this Agreement is terminated by a Party because of the breach of the Agreement by another Party or because one or more of the conditions to the terminating Party's obligations under this Agreement is not satisfied as a result of the other Party's failure to comply with its obligations under this Agreement, the terminating Party's right to pursue all legal remedies will survive such termination unimpaired for a period of six (6) months after such termination. 11.3 BREAK-UP FEE. In the event this Agreement is terminated by Sirius or the Shareholders pursuant to Section 11.1(a) or 11.1(b)(ii), or by DUSA pursuant to 11.1(e), 11.1(g) or 11.1(h), then DUSA shall pay to Sirius within five (5) business days following such termination, the Break-Up Fee. In the event this Agreement is terminated by DUSA pursuant to Section 11.1(a), 11.1(b)(i) or 11.1(f), then Sirius shall pay to DUSA within five (5) business days following such termination, the Break-Up Fee. With respect to the foregoing, the parties shall use their reasonable efforts to close the Transaction on or before February 7, 2006. Without 56 limiting the foregoing, a Material breach for purposes of Section 11.1(a) shall include, but not be limited to, Sirius' failure to deliver the Final Financial Statements to DUSA as required herein. ARTICLE XII SURVIVAL OF REPRESENTATIONS, WARRANTIES, COVENANTS AND AGREEMENTS 12.1 REPRESENTATIONS AND WARRANTIES. Except as otherwise provided for herein, all representations, warranties and covenants in this Agreement, the certificates delivered hereunder, and any other certificate or document delivered pursuant to this Agreement shall expire on the date which is twenty-four (24) months after the Closing Date. 12.2 LIMITATION OF LIABILITY. Notwithstanding anything herein to the contrary, the liability of each Sirius Shareholder for any claim for Damages made by DUSA or its Affiliates with respect to any matter arising out of or related to this Agreement or the Transaction shall be limited to DUSA's rights under Article XIII. ARTICLE XIII INDEMNIFICATION 13.1 INDEMNIFICATION OF DUSA INDEMNITEES. The Sirius Shareholders shall protect, defend, indemnify, and hold harmless DUSA and DUSA Sub and their respective Representatives, Affiliates, successors and permitted assigns (collectively, the "DUSA Indemnitees") from and against any and all Damages actually sustained or incurred by any of them, directly or indirectly, as a result of, in connection with, related to or arising out of: (a) any undisclosed liabilities of Sirius arising prior to the Closing Date; (b) subject to Sections 2.5(b) and 2.5(f), a court order, temporary restraining order, permanent injunction, cease and desist letter or other notice containing a significant threat to the continued manufacturing, production and/or marketing of a Product with respect to any Third Party Intellectual Property Rights relating to any of the Products. (c) any Material breach of any representation, warranty or covenant made by Sirius or a Principal Shareholder in this Agreement; (d) any tort claim, including, but not limited to, negligence and strict liability claims, and any claim for intentional misconduct or wrongdoing; and (e) any Taxes to the extent provided in Article XIV. Any assertion by the DUSA Indemnitees (or any of them) that the Sirius Shareholders are liable under the terms of this Section 13.1 must be made in a writing delivered to the Shareholders' Representatives and shall be subject to the limitations set forth below. 13.2 INDEMNIFICATION OF THE SIRIUS SHAREHOLDERS. DUSA shall protect, defend, indemnify and hold harmless each Sirius Shareholder from and against any and all Damages actually sustained or incurred by any of them, directly or indirectly, as a result of, in connection 57 with, related to or arising out of (a) a Material breach of any representation, warranty or covenant made by DUSA in this Agreement, (b) any action taken by DUSA, whether prior to or after the Closing, resulting in the failure of the transaction to qualify as a tax-free reorganization, or (c) all Taxes of Sirius (and claims with respect to such Taxes) with respect to all taxable periods beginning after the Closing Date as further provided in Article XIV. 13.3 LIMITATIONS. (a) No claims for breaches of representations, warranties, covenants or obligations may be brought by any DUSA Indemnitee or Sirius Shareholder after two (2) years following the Closing Date. No Person shall have any obligation to indemnify any other Person pursuant to this Agreement, unless the amount of Damages sustained or incurred with respect to a particular claim satisfy the criteria set forth in Section 2.5(c) hereof If this Agreement is terminated and the Closing does not occur, no Party shall have any obligation to indemnify any Person hereunder except with respect to any breaches of the covenants contained in Section 9.5 and Section 15.3 of this Agreement. (b) Any claim for indemnification made by any DUSA Indemnitee pursuant to Section 13.1 shall be satisfied, subject to the terms and conditions provided elsewhere herein, (i) first, from any applicable insurance policies covering Sirius or covering Sirius' Representatives, other than the Representation and Warranty Insurance, and (ii) second, from the Liability Escrow Account pursuant to the terms of Section 2.5 and as provided below, and (iii) thereafter, from the Representation and Warranty Insurance, if secured by DUSA. Notwithstanding the foregoing, nothing contained herein shall be deemed to prohibit or restrict application of the amounts held in the Liability Escrow Account from being applied to the deductible amounts with respect to any applicable insurance policies to be used for indemnification pursuant to clause (i) and (iii) hereof. (c) The indemnification provisions of this Article XIII shall constitute the exclusive remedy of the DUSA Indemnitees and the Sirius Shareholders, except for fraud and equitable remedies, with respect to any matter arising out of, related to or in connection with this Agreement. (d) If the DUSA Principal Officers (as defined below) have any Actual Knowledge (as defined below) as of the date of this Agreement as proven by Sirius in a court of competent jurisdiction or by other trier of fact as provided for in Article XVI that any Material representation or warranty made by Sirius or any Sirius Shareholder contained herein is incorrect in any Material respect as of the date of this Agreement, DUSA shall have no remedy or recourse with respect thereto. If, after the date of this Agreement and prior to the Closing Date, any of the DUSA Principal Officers are notified in writing or otherwise obtains any Actual Knowledge as proven by Sirius in a court of competent jurisdiction or by other trier of fact that any Material representation or warranty made by Sirius or any Sirius Shareholder is incorrect in any Material respect as of the date of this Agreement or the Closing Date, DUSA shall have as its sole remedy under this Agreement the option (i) to terminate this Agreement (upon providing ten (10) Business Days' written notice to Sirius and the Shareholders' Representative, during which period Sirius may cure such Material misrepresentation or Material breach of representation or warranty), or (ii) to proceed with the Closing and, upon the Closing, DUSA shall be conclusively 58 deemed to have waived all claims under this Agreement relating only to such Material misrepresentation or Material breach of representation or warranty. For purposes of this Section 13.3(d), "DUSA Principal Officers" means the following officers and/or employees of DUSA: (i) Dr. Geoffrey Shulman, Chairman and Chief Executive Officer, (ii) Mr. Robert Doman, President and Chief Operating Officer, (iii) Mr. Richard Christopher, Vice President, Finance and Chief Financial Officer, (iv) Mr. Michael Todisco, Controller, and (v) Mr. Scott Lundahl, Vice President, Regulatory Affairs and Intellectual Property. Also for purposes of this Section 13.3(d), "Actual Knowledge" means information that comes to such Principal Officers without obligation to make any investigation or inquiry of any kind by or on behalf of such Principal Officers. 13.4 GENERAL PROVISIONS. (a) All payments made by DUSA or any Sirius Shareholder, as the case may be, under this Article XIII shall be treated as adjustments to the Consideration for all Tax purposes. (b) The obligations of DUSA and the Sirius Shareholders in respect of a claim for indemnification under this Agreement shall not include any special, exemplary or consequential damages, including business interruption or lost profits, or any punitive damages. (c) DUSA and the Sirius Shareholders shall take all reasonable steps to mitigate their respective Damages upon and after becoming aware of any event which could reasonably be expected to give rise to any Damages that are indemnifiable hereunder. (d) Upon making any indemnification payment, the indemnitor will, to the extent of such payment, be subrogated to all rights of the indemnitee against any third party in respect of the Damages to which the payment relates. Without limiting the generality of any other provision hereof, each such indemnitor and indemnitee will duly execute upon request all instruments reasonably necessary to evidence and perfect the above-described subrogation rights. (e) DUSA agrees that the aggregate amount of indemnification to which it is entitled from one or more Sirius Shareholders in connection with any or all claims made by DUSA under this Article XIII shall be expressly and exclusively limited to the Liability Escrow Amount. (f) The Sirius Shareholders expressly agree that any indemnification obligation of Sirius may be, to the extent provided for in this Article XIII, satisfied from the Liability Escrow Account. 13.5 PROCEDURES FOR INDEMNIFICATION - THIRD PARTY CLAIMS. (a) For the purposes of this Section 13.5, the term "Indemnitee" shall refer to the Person(s) being indemnified, or entitled or claiming to be entitled to be indemnified pursuant to Section 2.5, 13.1 or 13.2 and "Indemnitor" shall refer to the Person(s) having the obligation to indemnify pursuant to such provisions. 59 (b) An Indemnitee shall, promptly after receiving notice of or becoming aware of any claim, including Third Party claims against it, but in any event within one hundred twenty (120) days thereof, give written notice to the Indemnitor. Such notification shall describe in reasonable detail (to the extent known by the Indemnitee) the facts constituting the basis for such claim and the amount of the claimed Damages; provided, however, that the failure to notify any Indemnitor will relieve the Indemnitor of any liability or obligation that it may have to such Indemnitee. A DUSA Indemnitee shall have satisfied this written notice requirement by giving such notice to the Shareholder Representatives on behalf of the Sirius Shareholders. (c) An Indemnitor will be entitled to participate in any Proceeding in connection with its obligations hereunder and, to the extent that the Indemnitor wishes (unless the Indemnitor is also a party to such Proceeding and the Indemnitee determines in good faith that joint representation would be inappropriate), to assume the defense of such Proceeding with counsel reasonably satisfactory to the Indemnitee and, after notice from the Indemnitor to the Indemnitee of its election to assume the defense of such Proceeding, the Indemnitor will not, as long as it diligently conducts such defense, be liable to the Indemnitee under this Agreement for any fees of other counsel or any other expenses with respect to the defense of such Proceeding, in each case subsequently incurred by the Indemnitee in connection with the defense of such Proceeding, other than reasonable costs of investigation. If the Indemnitor assumes the defense of a Proceeding: (i) it will be conclusively established for purposes of this Agreement that the claims made in that Proceeding are within the scope of and subject to indemnification; (ii) the Indemnitor will have no liability with respect to any compromise or settlement of such claims effected without its consent, other than reasonable, documented costs of investigation. (iii) the Indemnitee shall cooperate with the Indemnitor in such defense and make available to the Indemnitor all witnesses, pertinent records, materials and information in its possession or under its control relating thereto as is reasonably required by the Indemnitor; (iv) the Indemnitee may participate by its own counsel and at its own expense in the defense of such Third Party claim. (d) In the event the Indemnitee is, directly or indirectly, conducting the defense against any claim, the Indemnitor shall cooperate with the Indemnitee in such defense and make available to it all such witnesses, records, materials and information in its possession or under its control relating thereto as is reasonably required by the Indemnitee, and the Indemnitor may participate by its own counsel at its own expense in the defense of such Third Party claim. (e) Except for the settlement of a Third Party claim which involves the payment of money only, with respect to which the Indemnitor has agreed to indemnify the Indemnitee, no Third Party claim may be settled by the Indemnitor without the written consent of the Indemnitee, which consent shall not be unreasonably withheld, conditioned or delayed. No 60 Third Party claim may be settled by an Indemnitee without the written consent of the Indemnitor, which consent shall not be unreasonably withheld, conditioned or delayed. 13.6 PROCEDURE FOR INDEMNIFICATION - OTHER CLAIMS. A claim for indemnification for any matter not involving a Third Party claim may be asserted by notice to the Person from whom indemnification is sought. ARTICLE XIV TAX MATTERS 14.1 TAX ALLOCATION. The following provisions shall govern the allocation of responsibility as between DUSA and the Sirius Shareholders for certain tax matters following the Closing Date: (a) In the case of any taxable period that includes (but does not end on) the Closing Date (a "Straddle Period"), the amount of any Taxes based on or measured by income or receipts of Sirius for the Pre-Closing Tax Period shall be determined based on an interim Closing of the books as of the close of business on the Closing Date (and for such purpose, the taxable period of any partnership or other pass-through entity in which Sirius holds a beneficial interest shall be deemed to terminate at such time) and the amount of other Taxes of Sirius for a Straddle Period that relates to the Pre-Closing Tax Period shall be deemed to be the amount of such Tax for the entire taxable period multiplied by a fraction the numerator of which is the number of days in the taxable period ending on the Closing Date and the denominator of which is the number of days in such Straddle Period. (b) DUSA shall prepare or cause to be prepared and file or cause to be filed all Tax Returns for Sirius that are filed after the Closing Date. At the written request of the Sirius Shareholders, DUSA shall permit the Sirius Shareholders (through the Shareholder Representatives) to review and comment on each such Tax Return covering a Straddle Period prior to filing. (c) DUSA, Sirius and the Sirius Shareholders shall cooperate fully, as and to the extent reasonably requested by the other Party, in connection with the filing of Tax Returns pursuant to Section 14.1(d) and any audit, litigation or other proceeding with respect to Taxes. Such cooperation shall include the retention and (upon the other Party's request) the provision of records and information that are reasonably relevant to any such audit, litigation or other proceeding and making employees available on a mutually convenient basis to provide additional information and explanation of any Material provided hereunder. Sirius and the Sirius Shareholders agree (A) to retain all books and records with respect to Tax matters pertinent to Sirius relating to any taxable period beginning before the Closing Date until the expiration of the statute of limitations (and, to the extent notified by DUSA or the Sirius Shareholders, any extensions thereof) of the respective taxable periods, and to abide by all record retention agreements entered into with any taxing authority, and (B) to give the other Party reasonable written notice prior to transferring, destroying or discarding any such books and records and, if the other Party so requests, Sirius or the Sirius Shareholders, as the case may be, shall allow the other Party to take possession of such books and records. DUSA shall have responsibility for handling any audits of pre-Closing tax periods which occur after the Closing Date. 61 (i) DUSA and the Sirius Shareholders further agree, upon request, to use their best efforts to obtain any certificate or other document from any governmental authority or any other Person as may be necessary to mitigate, reduce or eliminate any Tax that could be imposed (including, but not limited to, with respect to the transactions contemplated hereby). (ii) DUSA and the Sirius Shareholders further agree, upon request, to provide the other Party with all information that either Party may be required to report pursuant to Code Section 6043 and all Treasury Regulations promulgated thereunder. (d) All tax-sharing agreements or similar agreements with respect to or involving Sirius shall be terminated as of the Closing Date and, after the Closing Date, Sirius shall not be bound thereby or have any liability thereunder. ARTICLE XV GENERAL PROVISIONS 15.1 EXPENSES. DUSA will bear its expenses incurred in connection with the preparation, execution, and performance of this Agreement and the transactions contemplated herein, including all fees and expenses of agents, representatives, counsel, and accountants. Additionally, DUSA shall be responsible to pay when due all transfer, documentary, sales, use, value added, stamp, registration, goods and services taxes, as well as all conveyance fees, recording charges and other fees and charges, incurred in connection with the transactions contemplated by this Agreement, regardless of whether the obligation to pay any such taxes, fees or charges would otherwise be the obligation of Sirius or the Sirius Shareholders under applicable law or by custom or practice. The parties hereto acknowledge that Sirius shall pay all Expenses in connection with this Agreement as provided in Section 6.3(a)(ii). 15.2 PUBLIC ANNOUNCEMENTS. Any public announcement or similar publicity with respect to this Agreement or the transactions contemplated herein will be issued, if at all, at such time and in such manner as DUSA and Sirius shall reasonably determine. Sirius and DUSA will consult with each other concerning the means by which the public and Sirius's employees, distributors, customers, and suppliers and others having dealings with Sirius will be informed of the transactions contemplated herein and no announcement shall be made by any party without the prior written consent of DUSA in the case of a proposed announcement by Sirius or of Sirius in the case of a proposed announcement by DUSA; provided, however, that this Section 15.2 shall not apply to DUSA's obligations to comply with applicable state and federal securities laws and the rules and regulations of the National Association of Securities Dealers and the NASDAQ National Market. 15.3 CONFIDENTIALITY. The provisions of the Mutual Confidential Agreement Disclosure between Sirius and DUSA dated June 20, 2005 ("Confidentiality Agreement") will continue in full force and effect and will survive the execution and delivery of this Agreement. 15.4 NOTICES. All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when: (a) delivered by hand (with written confirmation of receipt), (b) sent by facsimile (with written confirmation of receipt), provided that a copy is mailed by registered mail, return receipt requested, or (c) 62 when received by the addressee, if sent by a nationally recognized overnight delivery service (receipt requested), in each case to the appropriate addresses and facsimile numbers set forth below (or to such other addresses and facsimile numbers as a party may designate by written notice to the other parties): If to Sirius: With a copy to: Sirius Laboratories, Inc. Seyfarth Shaw LLP 100 Fairway Drive, Suite 130 55 East Monroe Street, Suite 4200 Vernon Hills, Illinois 60061 Chicago, Illinois 60603-5803 Attention: President and CEO Attention: Deborah Gordon, Esq. Telephone: No.: (847) 969-2424 Telephone: No.: (312) 781-8620 Facsimile No.: (847) 968-2484 Facsimile No.: (312) 269-8869 or, at such other address as Sirius or the Sirius Shareholders may designate by advance written notice to the other parties hereto; and If to the Shareholders Representative(s): and to: Frank Pollard Jeffrey Bernstein 3615 RFD 49 E. Division Street Long Grove, Illinois 60047 Chicago, Illinois 60611 Telephone No.: (847) 540-0413 Telephone No.: (312) 787-2573 Facsimile No.: (312) 787-2682 with a copy to: Seyfarth Shaw LLP (set forth above); or, in each case, at such other address such Shareholder Representatives or the Sirius Shareholders may designate by advance written notice to the other parties hereto; and If to DUSA: With a copy to: DUSA Pharmaceuticals, Inc. Reed Smith LLP 25 Upton Drive Princeton Forrestal Village Wilmington, Massachusetts 01887 136 Main Street, Suite 250 Attention: President and COO P.O. Box 7839 Telephone: No.: (978) 657-7500 Princeton, New Jersey 08543-7839 Facsimile No.: (978) 909-1016 Attention: Nanette W. Mantell, Esq. Telephone No.: (609) 987-0050 Facsimile No.: (609) 951-0824 or at such other address as DUSA may designate by advance written notice to the other parties hereto. 15.5 JURISDICTION; SERVICE OF PROCESS. Any action or proceeding seeking to enforce any provision of, or based on any right arising out of, this Agreement may be brought against any of the parties in the courts of the State of New York, or, if it has or can acquire jurisdiction, in the United States District Court for the Southern District of New York, and each of the parties consents to the jurisdiction of such courts (and of the appropriate appellate courts) in any such action or proceeding and waives any objection to venue laid therein. Process in any action or proceeding referred to in the preceding sentence may be served on any party anywhere in the world. 63 15.6 FURTHER ASSURANCES. The parties agree before and after Closing: (a) to furnish upon request to each other such further information, (b) to execute and deliver to each other such other documents, and (c) to do such other acts and things, all as the other party may reasonably request for the purpose of carrying out the intent of this Agreement and the documents referred to in this Agreement. 15.7 WAIVER. The rights and remedies of the parties to this Agreement are cumulative and not alternative. Neither the failure nor any delay by any party in exercising any right, power, or privilege under this Agreement or the documents referred to in this Agreement will operate as a waiver of such right, power, or privilege, and no single or partial exercise of any such right, power, or privilege will preclude any other or further exercise of such right, power, or privilege or the exercise of any other right, power, or privilege. To the maximum extent permitted by applicable law: (a) no claim or right arising out of this Agreement or the documents referred to in this Agreement can be discharged by one party, in whole or in part, by a waiver or renunciation of the claim or right unless in writing signed by the other party; (b) no waiver that may be given by a party will be applicable except in the specific instance for which it is given; and (c) no notice to or demand on one party will be deemed to be a waiver of any obligation of such party or of the right of the party giving such notice or demand to take further action without notice or demand as provided in this Agreement or the documents referred to in this Agreement. 15.8 ENTIRE AGREEMENT AND MODIFICATION. This Agreement supersedes all prior agreements between the parties with respect to its subject matter (other than the Confidentiality Agreement, which shall survive the execution and/or termination of this Agreement in accordance with its terms) and constitutes (along with the documents referred to in this Agreement and the Confidentiality Agreement) a complete and exclusive statement of the terms of the agreement between the parties with respect to its subject matter. This Agreement may not be amended except by a written agreement executed by all parties. 15.9 DISCLOSURE SCHEDULES. (a) If and to the extent any information required to be furnished in any Schedule is contained in another Schedule, such information will be deemed to be included in all Schedules in which such information is required to be included, to the extent such disclosure is reasonably apparent on its face to be applicable to such other Schedule. (b) In the event of any inconsistency between the statements in the body of this Agreement and those in the Disclosure Schedules, the statements in the body of this Agreement shall control. 15.10 ASSIGNMENTS, SUCCESSORS, AND NO THIRD-PARTY RIGHTS. No party may assign any of its rights or delegate its obligations under this Agreement without the prior consent of the other parties, except that DUSA may assign its rights or delegate its obligations hereunder to its Affiliates so long as DUSA remains ultimately liable for all of DUSA's obligations hereunder. Subject to the preceding sentence, this Agreement will apply to, be binding in all respects upon, and inure to the benefit of the successors and permitted assigns of the parties. Nothing expressed or referred to in this Agreement will be construed to give any Person other than the parties to this Agreement any legal or equitable right, remedy, or claim under or with respect to this Agreement 64 or any provision of this Agreement. This Agreement and all of its provisions and conditions are for the sole and exclusive benefit of the parties to this Agreement and their successors and assigns. 15.11 SEVERABILITY. If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement will remain in full force and effect. Any provision of this Agreement held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable. 15.12 ARTICLE AND SECTION HEADINGS, CONSTRUCTION. The headings of Sections in this Agreement are provided for convenience only and will not affect its construction or interpretation. All references to "Article," "Articles," "Section" or "Sections" refer to the corresponding Article, Articles, Section or Sections of this Agreement. All words used in this Agreement will be construed to be of such gender or number as the circumstances require. Unless otherwise expressly provided, the word "including" does not limit the preceding words or terms. 15.13 GOVERNING LAW. This Agreement will be governed by the laws of the State of New York without regard to conflicts of laws principles. 15.14 COUNTERPARTS. This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original copy of this Agreement and all of which, when taken together, will be deemed to constitute one and the same agreement. ARTICLE XVI DISPUTE RESOLUTION 16.1 ARBITRATION. Except as specified in Section 16.2 below, any dispute, controversy or other claim, including for indemnification pursuant to Article XIII, whether based on contract, tort, statute or other legal theory (including but not limited to claims of fraud or misrepresentation), arising out of or relating to this Agreement (including but not limited to its validity, interpretation, performance or breach) shall be resolved exclusively by arbitration pursuant to the then-current Commercial Rules and supervision of the American Arbitration Association ("AAA"). The arbitration shall be held in New York, New York. Each Party (the applicable Sirius Shareholders, as one party, and DUSA (and any applicable Person claiming by or through DUSA, including the DUSA Indemnitees), as one party) shall appoint one arbitrator within thirty (30) days after receipt by the respondent of the notice of arbitration. The two arbitrators appointed pursuant to the preceding sentence shall, within thirty (30) days after their appointment, appoint a third, presiding arbitrator. If either Party fails to nominate an arbitrator, or the two arbitrators appointed by the parties are unable to appoint a presiding arbitrator within the stated periods, the second or presiding arbitrator, as the case may be, shall be appointed by the AAA. All arbitrators shall be fluent in English and all hearings shall be conducted in the English language and shall have knowledge of the pharmaceutical industry and relevant markets. The arbitrators shall, by majority vote, render a written decision stating reasons therefor. The arbitrators shall not have the power to award punitive or exemplary damages, or any damages excluded by, or in excess of any limitations expressed in this Agreement. The arbitrators' decision and award shall be final and binding and may be entered in any court having jurisdiction 65 thereof. Issues of arbitrability shall be determined in accordance with the federal substantive and procedural laws relating to arbitration; all other aspects of this Agreement shall be interpreted in accordance with, and the arbitrators shall apply and be bound to follow the laws set forth in this Section 16.1. The costs and expenses of the arbitration shall be paid as the arbitrators determine. Any cash award shall be payable in United States dollars through a bank in the United States. 16.2 JUDICIAL PROCEEDINGS. Each Party shall have the right to institute judicial proceedings against the other Party or anyone acting by, through or under such other Party in order to enforce the instituting party's rights hereunder through specific performance, injunction or similar equitable relief. [Signature Page Follows.] 66 EXECUTION COPY IN WITNESS WHEREOF, the parties have executed and delivered this Merger Agreement as of the date first written above. SIRIUS LABORATORIES, INC. By: /s/ Frank R. Pollard --------------------------------------- Name: Frank R. Pollard Title: Vice Chairman DUSA PHARMACEUTICALS, INC. By:/s/ D. Geoffrey Shulman --------------------------------------- Name: D. Geoffrey Shulman, MD, FRCPC Title: Chairman and Chief Executive Officer THE SHAREHOLDERS /s/ Frank R. Pollard ------------------------------------------- Frank R. Pollard /s/ Jean E. Pollard ------------------------------------------- Jean E. Pollard /s/ Jeffrey R. Bernstein ------------------------------------------- Jeffrey R. Bernstein Ph.D. /s/ Carole Bernstein ------------------------------------------- Carole Bernstein /s/ Joel Bernstein ------------------------------------------- Joel Bernstein, M.D. /s/ David Bernstein ------------------------------------------- David Bernstein /s/ Rebecca Zelkin ------------------------------------------- Rebecca Zelkin /s/ Frank R. Pollard ------------------------------------------- Frank R. Pollard, Jr. /s/ Scott E. Pollard ------------------------------------------- Scott E. Pollard /s/ Brett A. Pollard ------------------------------------------- Brett A. Pollard /s/ Garry R. Barnes ------------------------------------------- Garry R. Barnes /s/ Luanna Barnes ------------------------------------------- Luanna Barnes /s/ Keyoumars Soltani ------------------------------------------- Keyoumars Soltani For Saeed Soltani ------------------------------------------- Saeed Soltani Power of attorney copy enclosed /s/ David H. Whitney ------------------------------------------- David H. Whitney Schedules and exhibits omitted pursuant to item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the Commission upon request. 2
EX-2.A.2 3 y18270exv2waw2.txt FIRST AMENDMENT TO MERGER AGREEMENT EXHIBIT 2(a.2) FIRST AMENDMENT TO MERGER AGREEMENT THIS FIRST AMENDMENT TO MERGER AGREEMENT (this "First Amendment") is made on the 6th day of February, 2006, by and among DUSA Pharmaceuticals, Inc., a publicly traded pharmaceutical company incorporated in the State of New Jersey, with principal offices at 25 Upton Drive, Wilmington, Massachusetts ("DUSA"), Sirius Laboratories, Inc., a privately held specialty pharmaceutical company incorporated in the State of Illinois, with principal offices at 100 Fairway Drive, Suite 130, Vernon Hills, Illinois ("Sirius"), and those shareholders of Sirius set forth on the signature pages hereto (each a "Principal Shareholder" and collectively the "Principal Shareholders"). DUSA, Sirius and the Principal Shareholders are at times referred to each as a "Party" and collectively as the "Parties." All capitalized terms used, but not specifically defined herein, shall have the meaning provided for such terms in the Merger Agreement (as defined below). R E C I T A L S WHEREAS, the Parties entered into that certain Merger Agreement, dated December 30, 2005 (as the same may be amended from time to time, the "Merger Agreement") whereby the Parties have agreed to effect a merger of Sirius with and into a wholly-owned subsidiary of DUSA ("DUSA Sub"), resulting in DUSA Sub being the surviving entity, the Sirius Shareholders receiving the consideration provided for therein, and DUSA owning all of the issued and outstanding common stock of DUSA Sub; and WHEREAS, the Parties wish to amend certain terms of the Merger Agreement in accordance with Section 15.8 of the Merger Agreement, as provided for herein. NOW, THEREFORE, the Parties, in furtherance of the foregoing and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, intending to be legally bound, agree as follows: 1. The following is added as a new Section 1.50a: 1.50a "First Amendment" means the First Amendment to Merger Agreement between the Parties dated February 6, 2006. 2. The following is added as a new Section 1.109a: 1.109a "Sirius Share Equivalents" means the interest in the Consideration held by former holders of Sirius Options who elect to cancel their Sirius Options in exchange for treatment (without the need for any payment) as if such holders had exercised two-thirds (2/3) of their Sirius Options for Sirius Shares. Holders of Sirius Options who elect such treatment are not considered holders of shares of Sirius common stock. 3. Sections 1.21, 1.22 and 1.23 are amended as follows: (a) In Section 1.21, replace "Thirty Million Dollars ($30,000,000)" with "Twenty-Five Million Dollars ($25,000,000)." (b) Delete Section 1.22 in its entirety and replace it with the following: ""Dissenters Multiplier" means the total number of Sirius Shares and Sirius Share Equivalents held by the Dissenting Shareholders as of the Closing Date divided by the total number of Sirius Shares on a fully diluted, as converted to common stock basis plus all Sirius Share Equivalents as of the Closing Date." (c) The following is added to the end of Section 1.23: "including any Non-Participating Sirius Option Holders (For sake of clarity, it is understood that the Non-Participating Sirius Option Holders are not, as result of holding Sirius Options, stockholders of Sirius, and the Dissenting Shareholders are not entitled to the Consideration set forth herein)." 4. The first sentence of Section 1.47 is deleted and replaced with the following: ""Fair Market Value" means for purposes of Section 2.2(c)(ii), the average closing price of DUSA Shares on the NASDAQ Stock Market for the last twenty (20) trading days of the month in which the applicable milestone is achieved, which average closing price shall be calculated by adding the closing price of DUSA Shares for each of the twenty (20) designated days and dividing the sum by twenty (20); and shall mean for purposes of Sections 2.2(b) and 2.5 the lesser of (i) the average closing price of DUSA Shares on the NASDAQ Stock Market for the twenty (20) trading days prior to the Closing Date, which average closing price shall be calculated by adding the closing price of DUSA Shares for each of the twenty (20) designated days and dividing the sum by twenty (20), or (ii) Ten Dollars and 10/100 ($10.10)." 5. The following is added as a new Section 1.80a: 1.80 "Non-Participating Sirius Option Holders" means any holders of Sirius Options who refuse or fail to participate in or take part in the Transaction, except those holders of Sirius Options who waive any and all rights under their Sirius Options, the Transaction and the Merger Agreement by completing, executing and delivering a waiver in a form and substance mutually acceptable to the Parties, provided that DUSA's acceptance shall not be unreasonably withheld or delayed." 6. The following is added to the end of Section 1.84: "including those holders of Sirius Options who elect to cancel their Sirius Options in exchange for Sirius Share Equivalents." 7. The following is added to the end of Section 2.2(a) and Section 2.2(b): "In addition, Schedule 3.3(a) shall set forth the amount paid with respect to Sirius Share Equivalents held by the Participating Shareholders. No amount shall be paid under this Section 2.2(a) with respect to any Dissenting Shareholder." 8. Section 2.3 is amended by deleting "February" and replacing it with "March." - 2 - 9. The following is added to the end of Section 2.4(b)(i): "(it being understood that those Participating Shareholders who do not provide wire instructions shall be mailed a check within five (5) Business Days of the Closing Date);" 10. The third sentence of Section 2.6 is deleted and replaced with the following: "In addition, each other Sirius Shareholder receiving DUSA Shares hereunder who also receives (as determined by Sirius in advance of the Closing) the estimated 2006 revenue and loss ranges for DUSA (following the consummation of the Transaction) shall agree to be subject to a lock-up of such DUSA Shares until the earlier of (i) the date on which DUSA releases its 2006 earnings to the public (which is estimated to be in February 2007), or (ii) the date on which such estimated 2006 revenue and loss ranges for DUSA (following the consummation of the Transaction) is announced to the public by DUSA or such information is deemed by DUSA in its reasonable discretion (in which case it will so notify such locked-up Sirius Shareholders) no longer Material to the business and operations of DUSA and/or DUSA Sub." 11. The following is added to the end of Section 2.9(a): "The Dissenters Escrow Agreement shall provide that, following the Closing, to the extent DUSA provides consideration to a Non-Participating Sirius Option Holder upon the exercise of, or in exchange for, a Sirius Option, including without limitation DUSA's grant of a stock option to purchase shares of DUSA's common stock in exchange for a Sirius Option, DUSA shall be entitled to receive from the Escrow Agent the amount corresponding to the lesser of (i) the amount such Non-Participating Sirius Option Holder is entitled to receive as a Dissenting Shareholder, or (ii) the actual value of any cash or shares of DUSA common stock issued by DUSA less any consideration received by DUSA by such Non-Participating Sirius Option Holder." 12. The following is added to the end of Section 6.3(a)(i): "and (C) the legal fees and expenses actually and reasonably incurred by Sirius in connection with the preparation of the First Amendment and any Information Statement dated after February 6, 2006; provided, further, that Sirius and its counsel shall provide DUSA with a detailed accounting of all such legal fees and expenses." 13. Section 11.1(k) and Section 11.3 are revised by deleting "February" and replacing it with "March." 14. All other terms and conditions of the Merger Agreement shall remain in full force and effect. This First Amendment shall not constitute a waiver or modification of any of the Parties' rights and remedies or of any of the terms, conditions, warranties, representations, or covenants contained in the Merger Agreement, except as specifically set forth above. 15. This First Amendment may be executed in counterparts, each of which, when taken together, shall be deemed to be one and the same instrument. [Signature Pages Follow.] - 3 - IN WITNESS WHEREOF, the parties have executed and delivered this First Amendment to Merger Agreement as of the date first written above. SIRIUS LABORATORIES, INC. By:/s/ Frank R. Pollard ---------------------------------------- Name: Frank R. Pollard Title: Vice Chairman DUSA PHARMACEUTICALS, INC. By:/s/ D. Geoffrey Shulman ---------------------------------------- Name: D. Geoffrey Shulman, MD, FRCPC Title: Chairman and Chief Executive Officer THE SHAREHOLDERS /s/ Frank R. Pollard ------------------------------------------- Frank R. Pollard /s/ Jean E. Pollard ------------------------------------------- Jean E. Pollard /s/ Jeffrey R. Bernstein ------------------------------------------- Jeffrey R. Bernstein Ph.D. /s/ Carole Bernstein ------------------------------------------- Carole Bernstein /s/ Joel Bernstein, M.D. ------------------------------------------- Joel Bernstein, M.D. /s/ David Bernstein ------------------------------------------- David Bernstein - 4 - /s/ Rebecca Zelken ------------------------------------------- Rebecca Zelken /s/ Frank R. Pollard ------------------------------------------- Frank R. Pollard, Jr. (Signature Page to First Amendment to Merger Agreement Continued) /s/ Scott E. Pollard ------------------------------------------- Scott E. Pollard /s/ Brett A. Pollard ------------------------------------------- Brett A. Pollard /s/ Garry R. Barnes ------------------------------------------- Garry R. Barnes /s/ Luanna Barnes ------------------------------------------- Luanna Barnes /s/ Keymoumars Soltani ------------------------------------------- Keyoumars Soltani For Saeed Soltani ------------------------------------------ Saeed Soltani Power of attorney copy enclosed /s/ David H. Whitney ------------------------------------------- David H. Whitney - 5 - EX-10.AA 4 y18270exv10waa.txt MARKETING DISTRIBUTION AND SUPPLY AGREEMENT Exhibit 10(aa) Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT BETWEEN DUSA PHARMACEUTICALS, INC. AND STIEFEL LABORATORIES, INC. DATED JANUARY 12, 2006 Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. MARKETING, DISTRIBUTION AND SUPPLY AGREEMENT made as of the 12th day of January 2006 (the "EFFECTIVE DATE") between DUSA PHARMACEUTICALS, INC., a New Jersey corporation having a principal office and place of business at 25 Upton Drive, Wilmington, Massachusetts, USA 01887 (hereinafter called "DUSA") and STIEFEL LABORATORIES, INC., a Delaware corporation having a principal office and place of business at 255 Alhambra Circle, Suite 1000, Coral Gables, Florida, USA 33134 (hereinafter called "STIEFEL"). WHEREAS, DUSA is engaged in the development, manufacture and sale of pharmaceutical products and wishes to market certain of its products in the Territory (as such term is defined below); WHEREAS, STIEFEL is a pharmaceutical company that distributes and sells pharmaceutical products in the Territory and desires to obtain an exclusive right to, distribute, promote, and sell in the Territory the Products as such term is defined manufactured by DUSA; WHEREAS, DUSA has agreed, subject to the terms and conditions of the Agreement, to grant STIEFEL an exclusive right to distribute, promote, and sell such Product in the Territory and to manufacture and supply to STIEFEL on an exclusive basis in the Territory all of STIEFEL's reasonable requirements of the Product; WHEREAS, STIEFEL has agreed to undertake the distribution, promotion, and sale of such Products in the Territory, and will purchase the Product exclusively from DUSA in accordance with the terms and conditions of this Agreement; and WHEREAS, the Parties also wish to memorialize the understanding between them with respect to DUSA's grant to STIEFEL of a license to use the DUSA Trademarks on the DUSA labeled Products in connection with the marketing and sale of the Product in the Territory under the terms and conditions of the Agreement. NOW, THEREFORE, the Parties agree as follows: 1. DEFINITIONS. For the purposes of this Agreement, capitalized terms used but not otherwise defined in this Agreement shall have the meanings set forth in this Section 1: 1.1 "AFFILIATES" shall mean any Person (defined below) which directly or indirectly controls, is controlled by, or under common control with a Party to this Agreement. For purposes of the foregoing definition, the term "control" (including with correlative meaning, the terms "controlling", "controlled by", and "under common control with") as used with respect to any Person, shall mean (i) in the case of corporate entities, direct or indirect ownership of at least [C.I.] percent ([C.I.]%) of the stock or shares entitled to vote for the election of directors; and (ii) in the case of non-corporate entities, direct or indirect ownership of at least [C.I.] percent ([C.I.]%) of the equity interest or the possession, directly or indirectly, of the power to direct or cause the Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. direction of the management and policies of such Person, whether through ownership of voting securities, by contract, or otherwise. 1.2 "APPLICABLE LAWS" shall mean all applicable laws, statutes, rules, regulations and guidelines that may apply to the sale of the Product in the Territory or the promotion, marketing, packaging, labeling, importation, exportation, warehousing or distribution of a Product that is to be sold in the Territory or the performance of either Party's obligations under this Agreement, and including all good manufacturing practices and all applicable standards or guidelines promulgated by the appropriate Regulatory Authority. 1.3 "APPROVED PRICE" shall mean the [C.I.] price per unit to STIEFEL [C.I.] for the sale of the Product in Brazil excluding up to [C.I.] Percent ([C.I.]%) in government sales taxes actually paid by STIEFEL on units of the Product sold. 1.4 "APPROVED PRODUCT" shall mean any Product that shall have been granted all necessary approvals by the required Regulatory Authorities to allow DUSA and/or Stiefel, as the case may be, the right to sell and distribute, promote, and sell the Product in any country in the Territory. 1.5 "BATCH", with respect to any of the Product, shall mean a separate and distinct quantity of such Product processed under continuous and identical conditions and designated by a batch number. 1.6 "CERTIFICATE OF CONFORMANCE" shall mean a document, which is dated and signed by a duly authorized representative of the Quality Control or Quality Assurance Department of DUSA, certifying that a Batch of any Product meets all Specifications. 1.7 "COMMERCIALLY REASONABLE EFFORTS" mean the channels, methods and diligence that a Party employs with respect to other products sold by it (including its own products) of the same or similar commercial potential. 1.8 "COMPETING PRODUCTS" means the products identified on Schedule A attached hereto as Competing Products. 1.9 "CONFIDENTIAL INFORMATION" means with respect to a Party, all information of any kind whatsoever (including without limitation, data, compilations, formulae, models, patent disclosures, procedures, processes, projections, protocols, results of experimentation and testing, specifications, strategies, techniques, business and financial information, projections, customer lists, and all non-public intellectual property rights, and all tangible and intangible embodiments thereof of any kind whatsoever (including without limitation, apparatus, compositions, documents, drawings, machinery, patent applications, records and reports), and all business information, financial data, projections, customer lists which is disclosed by such Party to the other Party. 1.10 "DOMAIN NAMES AND WEBSITES" shall mean those domain names and website agreed upon by the Parties through which the Products shall be marketed by STIEFEL hereunder. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. 1.11 "FDA" shall mean the U.S. Food and Drug Administration, or any successor body. 1.12 "FD&C ACT" means the Federal Food, Drug and Cosmetic Act of 1938, as amended and the regulations thereunder, as the same may be amended or revised. 1.13 "FIELD" shall mean [C.I.] uses of the Products for dermatology indications. 1.14 "FIRST APPROVAL DATE" shall mean the date on which DUSA first obtains approval to market a Product from a Regulatory Authority in the Territory. 1.15 "FISCAL YEAR" shall mean the twelve-month period commencing on January 1st of each year and ending on December 31st, or any other twelve-month period designated as the fiscal year of STIEFEL. 1.16 "GMP" shall mean good manufacturing practices as required by the rules and regulations of the applicable Regulatory Authority. 1.17 "GROSS-UP" shall have the meaning set forth in Section 7.2(a). 1.18 "INDEMNIFIED PARTY" shall have the meaning set forth in Section 14.3(a). 1.19 "INDEMNIFYING PARTY" shall have the meaning set forth in Section 14.3 (a). 1.20 "INDEPENDENT LABORATORY" shall have the meaning set forth in Section 9.4. 1.21 "LAUNCH DATE", as to each Approved Product, shall mean that date on which marketing and distribution of such Approved Product shall commence in a given country in the Territory. 1.22 "LAUNCH NOTICE" shall have the meaning set forth in Section 7.3(a). 1.23 "MINIMUM PURCHASE OBLIGATIONS" shall have the meaning set forth in Section 7.2(a). 1.24 "OBJECTION NOTICE" shall have the meaning set forth in Section 9.4. 1.25 "PARTY" means STIEFEL and DUSA, individually, and "PARTIES" means STIEFEL and DUSA, collectively. 1.26 [C.I.] shall have the meaning set forth on Schedule C attached hereto. 1.27 "PERSON" shall mean an individual, corporation, partnership, limited liability company, firm, association, joint venture, estate, trust, governmental or administrative body or agency, or any other entity. 1.28 "PRICING APPROVAL" shall mean STIEFEL's receipt from CMED of Registration of the [C.I.] price allowed to market and sell the Product in Brazil within the time period stated in Section 2.4 below, at a price of not less than [C.I.] Brazilian Reals (Brazilian Reals [C.I.]) per unit Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. including [C.I.] ([C.I.]%) government taxes (i.e.Net per unit to STIEFEL is [C.I.] Brazilian Reals (Brazilian Reals [C.I.])). 1.29 "PRODUCT" shall mean the product set forth on Schedule A. 1.30 "PRODUCT ALLIANCE MANAGER" shall have the meaning set forth in Section 5.1. 1.31 "PURCHASE PRICE PER UNIT" shall have the meaning set forth on Schedule C attached hereto. 1.32 "REGISTRATION" means the regulatory approvals of any applicable Regulatory Authorities issued in DUSA's name and necessary to permit the commencement of the marketing and sale of the Product in any country in the Territory. 1.33 "REGULATORY AUTHORITY" means any and all bodies and organizations regulating the manufacture, importation, distribution, use and sale of the Product in any country in the Territory. 1.34 "REPORT" shall have the meaning set forth in Section 9.4. 1.35 "SPECIFICATIONS" of Product means the specifications for the Product as approved by the FDA. The Specifications may be amended from time to time by [C.I.] and as specifically requested by applicable Regulatory Authorities. 1.36 "DUSA'S TRADEMARKS" shall mean the DUSA Trademarks set forth on Schedule A hereto, as such Schedule may be amended from time to time by mutual agreement of the parties. 1.37 "TECHNICAL INFORMATION" shall mean the manufacturing process and any and all technical knowledge, trade secrets, analytical methodology, processes, manufacturing and toxicological information, and any and all other technical information or experience related to the manufacturing of the Product. 1.38 "TERM" shall have the meaning set forth in Section 18.1. 1.39 "TERRITORY" shall mean all countries of the Western Hemisphere from south of and including Mexico, and all other countries located in the Caribbean excluding US territories. 1.40 "THIRD PARTY" means any party other than DUSA, STIEFEL or their respective Affiliates. 1.41 "THIRD PARTY LOSS" shall have the meaning set forth in Section 14.1. 1.42 "TRADEMARK INFRINGEMENT CLAIMS" shall have the meaning set forth in Section 3.3(a). Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. 2. DISTRIBUTION, MARKETING AND PROMOTION. 2.1 Appointment. During the Term and subject to Sections 2.2(b) and 7.1(a)(i), DUSA hereby appoints STIEFEL as its exclusive distributor for the Product in the Field in the Territory and STIEFEL hereby accepts such appointment. Pursuant to this appointment, STIEFEL shall have the exclusive right to import in finished package form, distribute, promote and sell the Product in the Field in the Territory subject to the terms and conditions of this Agreement. 2.2 Marketing and Promotion Efforts. (a) STIEFEL shall use its Commercially Reasonable Efforts to vigorously distribute, sell and promote the sale of the Product in the Field within and throughout the Territory [C.I.], so as to maximize sales in each country in the Territory, beginning [C.I.] after the date of this Agreement, provided that in the event that STIEFEL is legally prohibited from selling the Product until Registration for the Product is obtained, then STIEFEL shall begin distribution and promotion of the Product no later than [C.I.] ([C.I.]) days after Pricing Approval for the Product is obtained. (b) STIEFEL shall be deemed to have commenced the marketing of the Product in a country within the Territory [C.I.] when it shall have offered such Product [C.I.]. If STIEFEL does not begin marketing and promotion of the Product in a country within the Territory within [C.I.] ([C.I.]) days after receipt of all necessary government approvals to market the Product in such country, in addition to any other remedies available to DUSA hereunder or under law or in equity, DUSA may, in its sole discretion [C.I.] of such Product in such country. (c) STIEFEL shall provide DUSA as reasonably requested by DUSA on a [C.I.] basis: (1) [C.I.], as reasonably requested by DUSA for purposes of DUSA's [C.I.] within the Territory, (2) a summary of the [C.I.] of the Product held by STIEFEL at the end of such [C.I.] and (3) a report of [C.I.] of the Product sold by STIEFEL as requested by DUSA, including to comply with applicable laws. The Parties will mutually agree on the form(s) of reports, information to be contained therein and the timing of such reports regarding [C.I.] within [C.I.] ([C.I.]) days of the Effective Date, and such agreed upon items shall be attached to this Agreement as a Schedule D. (d) STIEFEL shall, [C.I.], use its Commercially Reasonable Efforts to distribute, promote, and sell the Product for use [C.I.], as appropriate in the Territory, in compliance with Applicable Laws and good commercial practice (including, but not limited to proper shipping and storage). (e) STIEFEL will not (and will ensure that its subdistributors, if any, do not) enter into any [C.I.] for the Product with its customers, including but not limited to [C.I.], that contain terms that exceed or are otherwise inconsistent with the terms of this Agreement (including but not limited to [C.I.] that exceed the term of this Agreement), without receiving DUSA's written approval, which may be withheld in its sole discretion, before entering into such agreement. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (f) STIEFEL shall purchase all Product needed in pre-marketing efforts from DUSA at the Purchase Price Per Unit; provided with respect to pre-marketing in Brazil, during the time that the Pricing Approval has not yet been received, STIEFEL shall purchase Product needed in pre-marketing efforts in Brazil from DUSA at [C.I.] U.S. Dollars (U.S. $[C.I.]) per unit. (g) Prior to STIEFEL marketing, promoting, distributing or selling a Product in the Territory, DUSA shall [C.I.] for the Product for STIEFEL's trainers, at [C.I.]. The [C.I.] shall use [C.I.] provided by DUSA and be limited only to provide medical information regarding the safety and efficacy of the Product in question [c.i.] the Products should be marketed, promoted, distributed or sold in the Territory. [C.I.] STIEFEL and its personnel, sales force or subdistributors, if any, regarding such medical information regarding the safety and efficacy and [C.I.], including without limitation marketing and promotion [C.I.], shall be the responsibility of [C.I.]. 2.3 Restrictions. (a) STIEFEL undertakes and agrees that it will not [C.I.] directly or indirectly [C.I.] the Product [C.I.] nor [C.I.] for the Product knowing that such [C.I.]. (b) Except as permitted pursuant to Section 2.5 below, during the term of this Agreement, STIEFEL shall not, nor shall it aid or facilitate [C.I.] to, market, promote, sell, offer for sale, distribute or otherwise make the Product available [C.I.], except as supplied to STIEFEL by DUSA, [C.I.] in the Territory. (c) STIEFEL warrants to DUSA that STIEFEL does not currently represent or promote [C.I.]. During the term of this Agreement, STIEFEL shall not, nor shall it aid or facilitate any Third Party to, market, promote, sell, offer for sale, distribute or otherwise make available [C.I.] to any person in the Territory. 2.4 Milestone Payments; Rights of Termination Relating to Pricing Approval. (a) Pricing Approval Milestone Payment. Within [C.I.] ([C.I.]) days of STIEFEL's receipt of the Pricing Approval, STIEFEL shall make a [C.I.], [C.I.] payment of [C.I.] U.S. Dollars (U.S. $[C.I.]) to DUSA. (b) First Units Shipped Milestone Payment. Within [C.I.] ([C.I.]) days following the total cumulative number of units of Product ordered hereunder by STIEFEL and shipped by DUSA to STIEFEL exceeding [C.I.] ([c.i.]) units, STIEFEL shall make a [C.I.], [C.I.] payment of [C.I.] U.S. Dollars (U.S. $[C.I.]) to DUSA. (c) Second Units Shipped Milestone Payment. Within [C.I.] ([C.I.]) days following the total cumulative number of units of Product ordered hereunder by STIEFEL and shipped by DUSA to STIEFEL exceeding [C.I.] ([c.i.]) units, STIEFEL shall make a [C.I.], [C.I.] payment of [C.I.] U.S. Dollars (U.S. $[C.I.]) to DUSA. (d) STIEFEL Right of Termination. If STIEFEL does not receive the Pricing Approval and STIEFEL wishes to terminate the Agreement, STIEFEL must give DUSA notice Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. of such termination within [C.I.] ([C.I.]) days of either (i) receiving a pricing approval not meeting the conditions of the Pricing Approval (as defined in Section 1.21), or (ii) failing to receive any approval within [C.I.] ([C.I.]) days of Registration; provided, however that STIEFEL shall not have such right to terminate if negotiations with CMED are on-going and DUSA and STIEFEL mutually agree, in writing, to extend such [C.I.] ([C.I.]) day period. In the event STIEFEL elects to terminate this Agreement, in addition to other effects of termination set forth herein, STIEFEL shall maintain any Registration for the Product, [C.I.], until DUSA is able to [C.I.]. (e) DUSA Right of Termination. If STIEFEL fails receive any approval from CMED within [C.I.] ([C.I.]) days of Registration, DUSA may elect to terminate this Agreement provided, however that DUSA shall not have such right to terminate if negotiations with CMED are on-going and DUSA and STIEFEL mutually agree, in writing, to extend such [C.I.] ([C.I.]) day period. In such event, in addition to other effects of termination set forth herein, (i) STIEFEL shall maintain any Registration for the Product, [C.I.], until DUSA is able to [C.I.], and (ii) STIEFEL shall be [C.I.] for any Product and [C.I.] ordered from DUSA on purchase orders submitted to DUSA prior to the date of termination. 2.5 Sub-Distributor. (a) Upon prior written notice to DUSA, STIEFEL shall have the right to appoint any sub-distributor to distribute, market, promote and/or sell the Product within the Territory. The appointment of any sub-distributor shall be in writing and on such terms and conditions as STIEFEL may reasonably require in writing provided such terms and conditions are not inconsistent with the terms and conditions of this Agreement. STIEFEL shall provide DUSA with complete, unredacted copies of each agreement appointing a sub-distributor hereunder. (b) STIEFEL acknowledges and agrees that the appointment of a sub-distributor hereunder shall not relieve STIEFEL of any of STIEFEL's obligations hereunder. STIEFEL further agrees that it shall, at all times, be solely responsible: (i) for the acts, deeds or omissions of any sub-distributor appointed pursuant to this Section 2.5; and (ii) for the compensation or for the wages, salaries and remunerations to any such sub-distributors or representatives, without any cost or liability to DUSA; (c) Sales made by such sub-distributors shall be [C.I.] by STIEFEL to DUSA and such sub-distribution arrangements shall not [C.I.] to DUSA in respect of such sales (that is, the [C.I.] to DUSA in respect of such Product sales shall be [C.I.] if STIEFEL had made the sale itself). (d) Each sub-distributor shall meet all obligations of STIEFEL hereunder with respect to the activities undertaken by such sub-distributor in the distribution, marketing and sale of the Product, including without limitation adverse event reporting and use of trademarks. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. 3. TRADEMARKS; PRODUCT MARKING. 3.1 DUSA Trademarks. (a) Ownership of DUSA Trademarks. STIEFEL shall use the DUSA Trademarks set forth on Schedule A for the Product and the Domain Names and Websites to distribute, market, promote, sell, package and label such Product during the Term in accordance with the Applicable Laws of the relevant Regulatory Authority. STIEFEL acknowledges and agrees that DUSA shall own all right, title and interest in and to each of the DUSA Trademarks and the Domain Names and Websites. During the Term: (i) STIEFEL and its Affiliates shall not [c.i.] of the DUSA Trademarks or the Domain Names and Websites, and agree that no ownership rights are vested or created in any of the DUSA Trademarks or the Domain Names and Websites by virtue of any licenses and other rights granted to STIEFEL under this Agreement; and (ii) all use of the DUSA Trademarks or the Domain Names and Websites in the Territory during the Term, whether in combination with or apart from any Party's corporate name, including any goodwill generated in connection therewith, inures to the benefit of DUSA, and DUSA may call for a confirmatory assignment thereof. (b) Use of DUSA Trademarks. Each Party shall use Commercially Reasonable Efforts during the Term not to do any act which endangers, destroys or similarly affects, in any material respect, the value of the goodwill pertaining to the DUSA Trademarks. Further, except when used in accordance with any usage guidelines agreed to by DUSA or except when a use is otherwise approved in accordance with other provisions of this Agreement, STIEFEL shall submit to DUSA any materials bearing the DUSA Trademarks for review and approval prior to the use thereof. (c) Costs. All costs of prosecuting and maintaining the DUSA Trademarks shall be paid by [C.I.]. 3.2 Other Proprietary Trademarks. (a) Ownership of Corporate Names. Each Party shall retain all right, title and interest in and to its corporate names, and agrees that it shall not [C.I.] of such other Party's corporate names, or any registrations issued or issuing with respect thereto. Each Party expressly acknowledges and agrees that no ownership rights are vested or created by the limited rights of use granted under this Agreement, and that all use of the corporate names in accordance therewith, including any goodwill generated in connection therewith, inures to the benefit of the respective owner of the corporate names and the owner of such corporate names may call for a confirmatory assignment thereof. (b) Use of Corporate Names. With respect to any corporate names licensed to a Party under or in connection with this Agreement, such Party agrees to conform to the customary guidelines of the granting Party with respect to manner of use (as provided in writing by the owner of the corporate name), and to maintain the quality standards of such granting Party with respect to the goods sold and services provided in connection with such Party's corporate names. Each Party shall [C.I.] not to do any act which endangers, destroys or similarly affects the Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. value of the goodwill pertaining to the other Party's corporate names. Further, except when used in accordance with any usage guidelines provided by the owner of a corporate name or a use is otherwise approved in accordance with other provisions of this Agreement, each Party shall submit to the other Party any materials bearing the other Party's corporate name for review and approval prior to the use thereof and shall make no use of such corporate name of the other Party without the other Party's written consent. Neither Party shall use, or allow any of their Affiliates to use, in connection with the Product any other trademark that is similar to or substantially similar to or so nearly resembles the other Party's corporate names as to be likely to cause deception or confusion. (c) Cooperation. Each Party shall execute any documents required in the reasonable opinion of the other Party to be entered as a "registered user" or recorded licensee of the other Party's corporate names, or to be removed as registered user or licensee thereof. 3.3 DUSA Trademarks Infringement. (a) Trademark Infringement Asserted by Third Parties in the Territory. Each Party shall notify the other Party promptly upon learning of any actual or alleged infringement of any trademark or of any unfair trade practices, trade dress imitation, passing off of counterfeit goods, or like offenses, or any such claims (hereinafter "TRADEMARK INFRINGEMENT CLAIMS") brought by a Third Party against a Party in connection with the Product in the Territory. (i) Upon learning of such Trademark Infringement Claim, DUSA, [C.I.], shall take reasonable and appropriate steps to resolve the Trademark Infringement Claim with the reasonable cooperation and assistance of STIEFEL; provided however DUSA [C.I.] such alleged infringement on behalf of STIEFEL [C.I.] of STIEFEL, [C.I.]. (ii) DUSA shall have the right to [C.I.]. (b) DUSA Trademarks Infringement by Third Parties in the Territory. Each Party shall notify the other Parties in writing promptly upon learning of any actual or alleged infringement by a Third Party of any DUSA Trademarks in the Territory of which they become aware. (i) Upon learning of such infringement under this Section 3.3(b), DUSA shall, [C.I.], take reasonable and appropriate steps to resolve such infringement with the reasonable cooperation and assistance of STIEFEL; provided however DUSA [C.I.] such alleged infringement on behalf of STIEFEL [C.I.] STIEFEL, [C.I.]. (ii) DUSA shall have the right to [C.I.]. 3.4 Product Marking. Any Product marketed and sold hereunder shall be marked with appropriate patent numbers and Trademarks, as approved by DUSA. 3.5 Alternative Trademarks. If one or more the DUSA Trademarks cannot be used or registered in any country within the Territory for reasons beyond DUSA's control (e.g., due to objections by Third Parties or local trademark offices) or cannot otherwise be legally used to Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. commercialize the Product in a country within the Territory (e.g., due to rejection by regulatory authorities), and if the Parties have determined that an alternative worldwide trademark is not practicable for the Product, then [C.I.] shall have the right to propose one or more alternative trademarks. [C.I.] shall then select one of the alternative trademarks for the Product in each country in the Territory. [C.I.] will undertake the obligation and expense of conducting appropriate trademark clearance of any such selected alternative trademark for use in each such country in the Territory, and filing applications for the cleared trademark. If (a) an alternative trademark is cleared successfully for use and registration, (b) trademark applications are filed for the additional alternative trademark, and (c) such additional alternative trademark receives regulatory approval, then all terms and conditions of this Agreement shall apply, mutatis mutandis, to the use and registration of such alternative trademark approved [C.I.] and, thereafter the term "DUSA Trademarks" shall include such alternative trademark. 4. REGISTRATIONS. 4.1 Approval and Maintenance. (a) DUSA shall, [C.I.], use Commercially Reasonable Efforts to prepare the documents necessary for submission to the Regulatory Authorities in Brazil to seek approval for the treatment of Actinic Keratoses. [C.I.] shall [C.I.] for [C.I.] incurred on or after the Effective Date, including but not limited to, [C.I.], and [C.I.] in connection with seeking Registration in Brazil. [C.I.] shall be responsible for [C.I.] prior to the Effective Date, including but not limited to, [C.I.], and [C.I.] in connection with seeking Registration in Brazil. (b) STIEFEL shall, [C.I.], provide [C.I.] with reasonable assistance and cooperation in [C.I.] preparing, filing, seeking and maintaining Registration in Brazil, which shall include, but not be limited to, the naming of a [C.I.] and developing and implementing documented standard operating procedures required to support the Product Registration. If the Pricing Approval is not obtained and STIEFEL wishes to terminate the Agreement, STIEFEL shall continue to perform all necessary activities to maintain DUSA's regulatory approval for the Product, [C.I.], until DUSA is able to [C.I.]. (c) For other countries in the Territory and/or other indications in the Field, STIEFEL shall, [C.I.], use [C.I.] to prepare the application for Registration, on [C.I.] behalf, to seek approval to market. With regard to the application for Registration for the treatment of Actinic Keratoses, DUSA will provide STIEFEL with copies of existing clinical and chemistry, manufacturing and controls data to support of this application. STIEFEL shall [C.I.] for [C.I.], including but not limited to, [C.I.], and [C.I.] in connection with seeking these approvals. STIEFEL shall, [C.I.], provide DUSA with reasonable assistance with the development and implementation of mutual documented standard operating procedures, such as, but not limited to, adverse event reporting, storage and handling, etc., required to support the Registration in other countries in the Territory. (d) For clarity, regulatory [C.I.] shall mean all [C.I.] and [C.I.] (including [C.I.]) incurred by a Party or any of its Affiliates in accordance with GAAP during the term and pursuant to this Agreement in connection with the preparation of regulatory submissions for the Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. Product, the obtaining and maintenance of Registrations, and compliance with Registrations and requirements of such Regulatory Authorities, including ICSR recordation and reporting, regulatory affairs activities, and recalls and withdrawals of the Product in the Territory. [C.I.] shall report to [C.I.] within [C.I.] ([C.I.]) days after the end of each calendar [c.i.] with regard to regulatory costs incurred during such calendar [C.I.]. Such report shall (i) specify in reasonable detail all expenses incurred during such [C.I.], or (ii) be accompanied by invoices or other appropriate supporting documentation for any payments to Third Parties that individually exceed $[C.I.] or such [C.I.] as may be determined by the Parties. The Parties shall seek to resolve any questions related to such accounting statements within [C.I.] ([C.I.]) days following receipt by STIEFEL of DUSA's report hereunder and payment shall be made within [C.I.] ([C.I.]) days of such report. 4.2 Adverse Event Reporting. STIEFEL shall notify DUSA, in writing, of any adverse drug experience within [C.I.] ([C.I.]) hours of such adverse drug experience becoming known to STIEFEL. As provided in Section 4.5, and except as required by any Applicable Laws, DUSA shall have the sole discretion and responsibility to determine whether any adverse drug experience must be reported to the applicable Regulatory Authority, and following making a determination to report, to report such events to the applicable Governmental Authority. 4.3 Ownership of Product Registration. All Registrations and regulatory filings for the Product in the Territory, including marketing and pricing filings and authorizations, in connection with the Product, shall be filed, registered and owned exclusively by DUSA, unless otherwise explicitly agreed in writing by DUSA. 4.4 Cooperation. (a) STIEFEL shall, [C.I.], provide DUSA with reasonable assistance and timely cooperation in the preparation, filing, submission and maintenance of Registrations, which shall include naming of a [C.I.] in Brazil, and in any country in the Territory which requires it. (b) At DUSA's reasonable request, STIEFEL will assist DUSA, in determining the optimal form of, and the necessary information to be included in, such filings to meet the applicable requirements of the Regulatory Authority in the Territory. (c) From time to time, each Party shall provide the other Party with a status of its efforts in attempting to obtain Registration for the Product in each country in the Territory. 4.5 Communications; Regulatory Inspections and Notifications. At all times, [C.I.] shall have [C.I.] with the applicable Regulatory Authorities regarding the manufacture, marketing and sale of the Product. DUSA and STIEFEL each shall notify the other within [C.I.] ([C.I.]) hours (or, if such [C.I.] ends on a non-business day, then prior to noon on the next following business day) of receipt of any notice of any governmental agency inspection, investigation or other inquiry, or other material governmental notice or communication, in each case which relates to the marketing, promotion, distribution and/or detailing of the Product within the Territory during the term of this Agreement. [C.I.] shall discuss any response to observations or Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. notifications received in connection with any such inspection, investigation or other inquiry and each shall give the other an opportunity to comment upon any proposed response before it is made. In the event of disagreement concerning the form or content of such response, however, DUSA shall be responsible for deciding the appropriate form and content of any response with respect to any of its cited activities and STIEFEL shall be responsible for deciding the appropriate form and content of any response with respect to any of its cited activities. STIEFEL will provide DUSA with copies of all correspondence received by it from, or filed by it with, any Regulatory Authority to the extent pertaining to the Product or its marketing, promotion or detailing in the Territory. 4.6 Notwithstanding anything contained herein to the contrary, [C.I.] shall have no obligation to perform, complete or undertake [C.I.] activities or [C.I.] activities relating to the Product in furtherance of STIEFEL's rights under this Agreement. 5. ALLIANCE MANAGERS AND MEETINGS. 5.1 Product Alliance Manager. Each Party will appoint an employee with appropriate authority and experience to act as a liaison ("PRODUCT ALLIANCE MANAGER") to communicate information concerning the Product and its marketing and promotion by STIEFEL. The Product Alliance Manager shall be responsible for calling meetings, preparing, and circulating an agenda in advance of meetings of the Parties and preparing and issuing minutes of each meeting within [C.I.] ([C.I.]) days thereafter. 5.2 Meetings. The Parties shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every [C.I.]. The first meeting of the Parties shall be held not more than [C.I.] ([C.I.]) days after the Effective Date. Thereafter, the Parties shall meet at such locations as the Parties may agree. Each Party shall be responsible for [C.I.]. [C.I.] agrees to take into good faith consideration all comments received [C.I.] in connection with STIEFEL's marketing and promotion of the Products in the Field in the Territory, and in particular to [C.I.] to undertake all such marketing and promotion in a manner consistent with and supportive of DUSA's global marketing, promotion, development and commercialization of the Product world-wide. 6. LABELING. 6.1 Labels. (a) Subject to Section 6.1(b), DUSA shall package and label each of the Approved Products in accordance with the Specifications and in accordance with the packaging and labeling agreed between the Parties; provided that the Parties shall follow all legal requirements in effect throughout the Territory, as applicable, and that the STIEFEL's or its designated Affiliate's name and logo shall be prominently displayed on all Product packaging. (b) STIEFEL shall supply camera ready labeling and package insert copy, and with the art work for such packaging and labeling, to DUSA sufficiently in advance of any purchase order delivery timelines requested by STIEFEL to allow DUSA to manufacture and Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. label the Product, including sufficiently in advance of launch. All such labeling, copy and artwork provided by STIEFEL shall comply with applicable specifications and regulatory requirements. The labeling for each Product will indicate that DUSA is the manufacturer of such Product and that STIEFEL is the distributor and/or agent for the Product. (c) DUSA shall be fully responsible for the form and content of all Product labels and other aspects of Product packaging and labeling, except to the extent of claims relating to label information and content supplied by STIEFEL. 7. MANUFACTURE AND SUPPLY OF THE PRODUCTS. 7.1 General. DUSA shall manufacture, or cause a Third Party to manufacture on its behalf [C.I.], the Product in accordance with the Specifications and supply the Product to STIEFEL pursuant to forecasts and purchase orders placed by STIEFEL in accordance with this Section 7. 7.2 Minimum Purchase Obligations; Inventory. (a) STIEFEL shall purchase, no less than the Minimum Number of Units of the Product at the Purchase Price Per Unit during the applicable Time Period (as such terms are defined on Schedule B) (the "MINIMUM PURCHASE OBLIGATIONS"); provided however if DUSA exercises [C.I.] to Brazil during a [C.I.] with respect to Brazil pursuant to Section 8.3(a) and such [C.I.] causes STIEFEL not to meet its Minimum Purchase Obligations for a Time Period, then (i) the Minimum Purchase Obligations shall be [C.I.] and [C.I.] on which DUSA exercises its right to [C.I.] to Brazil during a [C.I.] with respect to Brazil pursuant to Section 8.3(a), and (ii) [C.I.] on (x) appropriate pro-rata adjustments to the Minimum Purchase Obligations which are to apply to Time Periods during which supply to Brazil has been [C.I.] (including the present Time Period in question), and (y) a plan for the Product in Brazil which may include amendments to this Agreement as necessary and appropriate. Within [C.I.] ([C.I.]) days of the end of each Time Period, the Parties shall review the purchases made by STIEFEL for the immediately preceding Time Period. If it is determined from the review that STIEFEL has not met its Minimum Purchase Obligations for such preceding Time Period, STIEFEL shall immediately [C.I.] DUSA [C.I.] from STIEFEL for purchases of the number of units meeting the Minimum Purchase Obligations and [C.I.] by DUSA for the number of units of Product purchased during such preceding Time Period [C.I.]. If STIEFEL fails to meet its Minimum Purchase Requirement for [C.I.] consecutive Time Periods or STIEFEL [C.I.] with respect to any Time Period, in addition to any other remedies available to DUSA hereunder or under law or in equity, DUSA may, in its sole discretion either: (i) [C.I.] of such Product in such country, provided that DUSA does not waive its right to terminate the Agreement under Section 7.1(a)(ii) even if it [C.I.], or (ii) [C.I.] the Agreement upon giving written notice thereof to STIEFEL. For purposes of clarity, DUSA retains its [C.I.] Agreement pursuant to Section 7.1(a)(ii) at any time thereafter even if DUSA initially chooses to [C.I.] in the Territory. STIEFEL shall [C.I.] within [C.I.] ([C.I.]) days of completion of the review in United States dollars via wire transfer, check or other instrument approved by DUSA. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (b) Inventory. STIEFEL shall, [C.I.], maintain [C.I.] inventory of the Product at all times during the term of this Agreement as necessary in order to meet the marketing demand requirements of any customer or potential customer within the Territory. 7.3 Forecast and Purchase Orders. STIEFEL shall provide forecasts and purchase orders to DUSA for Product as follows: (a) Within [C.I.] ([C.I.]) months of the Effective Date with respect to Brazil, and within [C.I.] ([C.I.]) months prior to any other anticipated Registration relating to the Product, STIEFEL shall provide DUSA with a forecast of STIEFEL's quantity requirements for the applicable commercial launch of the Product and the [C.I.] period following such launch. STIEFEL shall send to DUSA a notice (the "LAUNCH NOTICE") with respect to such Product that shall contain the following: (i) a statement of the estimated Launch Date of such Product; and; (ii) a good faith forecast of the quantities that will in the future be purchased by STIEFEL prior to the Launch Date. (b) At least [C.I.] ([C.I.]) days prior to any anticipated Launch Date of the Product in the Territory, STIEFEL shall provide DUSA with a firm purchase order for its requirements for commercial launch of the Product which shall be for an amount of Product [C.I.] STIEFEL's first [C.I.] of forecasted sales. Thereafter STIEFEL shall issue purchase orders for its requirements of Product on the last day of each calendar [C.I.]. (c) Each purchase order shall be accompanied by a rolling forecast of STIEFEL's requirements of Product for the [C.I.] following the [C.I.] for which the purchase order pertains, provided however that STIEFEL shall have no obligation to make purchase order or forecasts for any time beyond the term of this Agreement. If a required forecast for a [C.I.] is not timely submitted, the last submitted [C.I.] forecast shall become the new forecast. (d) Each purchase order (including without limitation those provided to DUSA prior to the commercial launch of the Product) shall be firm and binding. (e) Each purchase order shall specify the delivery date for the Product and the quantity of Product ordered. The delivery date shall be no sooner than [C.I.] ([C.I.]) days following the date such purchase order is issued. The quantity of Product specified shall not be less than [C.I.]% or more than [C.I.]% of the most recent previous forecast for such quarter, unless otherwise agreed to by DUSA in writing. (f) STIEFEL's forecasts and purchase orders shall reflect its good faith expectations of customer demand and STIEFEL shall [C.I.] to schedule orders to avoid creating production capacity problems for DUSA. (g) All Product shall be delivered by DUSA to STIEFEL FOB (as defined in the Incoterms 2000) the manufacturing facility utilized by DUSA to the destination specified in the applicable purchase order. STIEFEL shall [C.I.] to the Territory, and [C.I.] in connection therewith. Title and risk of loss for the Product shall transfer from DUSA to STIEFEL following delivery of the Product to the common carrier at the manufacturing facility utilized by DUSA. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (h) STIEFEL shall have [C.I.] except for [C.I.] as defined in Section 9.1(a). 8. PRICE AND PAYMENT; SUSPENSION OF SUPPLY AND RENEGOTIATION. 8.1 Payment for Purchase Orders. Subject to Section 7.3(a), STIEFEL shall pay for the quantities of Product ordered at the applicable Purchase Price Per Unit (as set forth on Schedule C hereto) within [C.I.] ([C.I.]) days of the date of invoice submitted by DUSA, provided that DUSA shall not [C.I.] the Product has been delivered to STIEFEL pursuant to Section 7.3(g). All payments shall be made in [C.I.], by wire transfer, preferably [C.I.], of immediately available funds [C.I.]. 8.2 Late Fee. All payments made after the date it is due and payable shall accrue interest at the [C.I.] as set forth in the Wall Street Journal, plus [C.I.] percent ([C.I.]%) per year or the maximum amount allowable by law. 8.3 Suspension of Supply and Renegotiation. During a [C.I.] with respect to a country in the Territory (as defined on Schedule C attached hereto): (a) DUSA may from time to time or during the [C.I.], in DUSA's sole discretion and without being liable to STIEFEL in any manner or in breach of any provision of this Agreement, [C.I.] to supply Product with respect to such country to STIEFEL under this Agreement and/or any order for Product with respect to such country placed by STIEFEL in connection with this Agreement; (b) DUSA may from time to time or during the [C.I.], in DUSA's sole discretion, [C.I.] Product with respect to such country to STIEFEL under this Agreement under any order for Product placed by STIEFEL in connection with this Agreement, including any such order with respect to which STIEFEL agrees to pay DUSA; and (c) DUSA may (if not already included with the initial notice given by DUSA pursuant to and as permitted under Schedule C hereto) give further notice to STIEFEL requesting that the Parties [C.I.] of this Agreement with respect to such country. 8.4 Diversion of Product; Currency of Orders. As part of placing each order for the Product, STIEFEL shall indicate in writing the country in the Territory where such ordered Product is intended to be sold. Product purchased as being indicated for sale in a given country shall not be sold in any other country. Orders shall be placed in U.S. Dollars, adjusted at the then applicable local currency / U.S. Dollar exchange rate for the currency of the country where Product is intended to be sold. 9. QUALITY CONTROL AND PRODUCT ACCEPTANCE. 9.1 Quality Control. (a) DUSA shall ensure that all Products supplied to STIEFEL under the terms of this Agreement will meet Specifications. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (b) DUSA shall conduct all quality control testing of the Product prior to shipment in accordance with the Specifications and requirements of the applicable Regulatory Authority. (c) DUSA shall retain records and samples of Product relating to such testings as required by applicable Regulatory Authorities and, from time to time, upon prior notice from STIEFEL, provide STIEFEL with reasonable access to such records in accordance with Section 17 below. 9.2 Delivery Documents. DUSA shall ensure that each Batch of Product is labeled and each Batch number is applied to each such Batch, as required by the applicable Regulatory Authority. DUSA will ensure that a copy of the Certificate of Conformance with respect to each Batch of Product supplied to STIEFEL is (a) faxed to STIEFEL prior to shipping such Batch to STIEFEL (confirmed by hard copy mailed to STIEFEL) and (b) accompanies each Batch. DUSA shall not ship any Batch to STIEFEL if such Batch does not meet Specifications. 9.3 Storage. (a) DUSA shall provide and maintain suitable storage and transport conditions for each Batch of Product and shall provide STIEFEL with complete written instructions with respect to proper conditions for the transport and storage of Product. (b) Upon receipt of any Batch of Product, STIEFEL shall provide and maintain suitable storage conditions therefor and shall comply with any product labeling and written instructions provided by DUSA in respect of the transport and storage of Product. 9.4 Acceptance and Rejection of Product. (a) All shipments of Product received by STIEFEL shall be deemed accepted unless STIEFEL gives DUSA a written notice (the "OBJECTION NOTICE") within [C.I.] ([C.I.]) days of such receipt specifying the manner in which the Batch of Product does not conform to Specifications. (b) The Objection Notice shall be accompanied by written reports of any testing performed by or for STIEFEL on such Batch. Upon receipt of the Objection Notice, DUSA may request STIEFEL to [C.I.] thereof for further testing. The test results, if any, submitted to DUSA by STIEFEL shall be deemed conclusive unless DUSA notifies STIEFEL within [C.I.] ([C.I.]) days of its receipt of the Objection Notice or the samples, whichever is later, that it disagrees with such test results. (c) Should DUSA wish to verify STIEFEL's conclusion in an Objection Notice, DUSA shall submit the rejected Product or samples to an independent laboratory (the "INDEPENDENT LABORATORY") for analysis and the Independent Laboratory shall submit its findings in the form of a written report (the "REPORT"), the [C.I.] by [C.I.]; provided, however, if the results of the Report determine that any of the Product rejected by STIEFEL does not meet the applicable Specifications, [C.I.] for all such [C.I.]. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (d) DUSA shall [C.I.] to [C.I.] Product that does not meet the applicable Specifications with conforming goods as soon as reasonably possible, provided that the departure from Specifications is not the direct result of the [C.I.] of STIEFEL. In the event that [C.I.] Product is required, it shall be [C.I.] unless otherwise agreed to in writing by STIEFEL. 9.5 Limitation of Product Warranty. At no time shall STIEFEL make any representation or extend the warranty regarding any Product which is not first approved by DUSA in writing. All representations and warranties made by STIEFEL regarding the Product must be strictly limited to the representations and warranties made by the manufacturer of the Product at the time such Product is made. 10. RECORDS. 10.1 Record Retention. (a) The Parties shall maintain all necessary and appropriate records and documents relating to the sale of the Product. The retention period for records for both Parties shall be: (i) the time period meeting all known regulations of the applicable Regulatory Authorities with respect to such Product; and (ii) [C.I.] ([C.I.]) years from the date of sale, whichever is longer. (b) The parties shall use commercially reasonable efforts to ascertain the retention requirements of the applicable Regulatory Authorities and will keep the other Party informed of any changes that it becomes aware of that may reasonably affect such other Party's obligations under this Section 10.1. 11. INTELLECTUAL PROPERTY RIGHTS. 11.1 Technical Information. STIEFEL acknowledges and agrees that DUSA is the owner of the Technical Information, and of all industrial and intellectual property rights of any kind in relation to the Technical Information, including the right to patents, registered or other designs, copyrights, trademarks or trade names and any other Confidential Information. Nothing contained in this Agreement shall be effective to give STIEFEL any rights of ownership in and to the Technical Information or to the intellectual property owned by DUSA. 11.2 Improvements. Any improvements to the Technical Information made or discovered by DUSA during the term of this Agreement shall remain the property of DUSA and all industrial and intellectual property rights of any kind in relation to such improvements, including the right to patents, registered or other designs, copyrights, trademarks or trade names and any other Confidential Information, shall remain the property of DUSA. 11.3 Confidential Information. Within the term of this Agreement and after its termination or expiration, it is agreed upon between the parties that the Technical Information Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. and all industrial and intellectual property rights of any kind in connection with or related to the Technical Information shall be considered as Confidential Information and shall be treated and protected by STIEFEL in accordance with the terms of Section 16. 12. RELATIONSHIP OF DUSA AND STIEFEL. 12.1 Independent Relationship. The relationship between DUSA and STIEFEL that is created by this Agreement shall be that of vendor and purchaser, and not that of a partnership, principal and agent, or joint or co-ventures. In the performance of this Agreement, STIEFEL shall have no authority to assume or create any obligation or responsibility, either expressed or implied, on behalf of or in the name of DUSA, or to bind DUSA or its Affiliates in any manner whatsoever and DUSA shall have no authority to assume or create any obligation or responsibility, either express or implied, on behalf of or in the name of STIEFEL or to bind STIEFEL or its Affiliates in any manner whatsoever. Each Party shall indemnify the other Party for any claim asserted by any Third Party that the acts of such Party or any of its Affiliates created any obligation or responsibility of the other Party other than as expressly set forth in this Section. 12.2 Use of Names. If this Agreement is terminated for any reason, neither Party shall thereafter use, or permit anyone else under its control to use, the other's name in the promotion of its business or the offer for sale of any goods and neither Party shall package or label any goods in a manner that the other Party hereto might reasonably consider to be imitative of any goods sold by such Party. 13. REPRESENTATIONS AND WARRANTIES. 13.1 By STIEFEL. STIEFEL hereby represents and warrants to DUSA that: (a) it has the corporate authority to enter into this Agreement and to perform its obligations hereunder; (b) it is not aware of any legal, contractual or other restriction, limitation or condition which might affect adversely its ability to perform hereunder; and (c) it shall at all times sell, market, handle and store the Product in compliance with all Applicable Laws. 13.2 By DUSA. DUSA hereby represents and warrants to STIEFEL that: (a) it has the corporate authority to enter into this Agreement and to perform its obligations hereunder; (b) it is not aware of any legal contractual or other restriction, limitation or condition which might affect adversely its ability to perform hereunder; (c) all Product shipped to STIEFEL pursuant to this Agreement (i) shall be manufactured, packaged and labeled in conformance with the applicable Specifications for such Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. Product at the time of shipment; (ii) shall be manufactured, packaged and labeled at the manufacturing facilities utilized by DUSA which meets the requirements of the applicable Regulatory Authority where the Product is manufactured and sold, including, without limitation, conformance with GMP, (iii) shall be stored and handled by DUSA at all times in the proper manner and suitable conditions for such Product. 13.3 Debarment. Each Party hereby represents, warrants and covenants to the other that: (a) It is not debarred under the Generic Drug Enforcement Act of 1992 and it does not and will not use in any capacity the services of any person debarred under the Generic Drug Enforcement Act of 1992; and (b) To the best of its knowledge, none of its employees, agents or contractors, has engaged in any activity which could lead to it becoming debarred under the Generic Drug Enforcement Act of 1992. 13.4 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION 13, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE OR USE. 14. INDEMNIFICATION. 14.1 By STIEFEL. STIEFEL agrees to indemnify DUSA against and hold DUSA harmless from, any and all [C.I.] loss (except [C.I.], such as, for example, [C.I.]), [C.I.], [C.I.], [C.I.], [C.I.] and [C.I.] (including, without limitation, [C.I.] and liabilities for [C.I.]) ("THIRD PARTY LOSS") arising from or in connection with any: (a) breach of the warranties by STIEFEL hereunder; (b) other misrepresentation or breach of this Agreement by STIEFEL or the [C.I.] of STIEFEL in connection with its contract obligations hereunder (c) claim (expressed or implied) by STIEFEL, its Affiliates or its sub-distributors, (except to the extent that such claim has been approved by the Regulatory Authority or authorized by DUSA) as to the efficacy or safety of the Product or the use to be made by any purchaser of the Product; provided that DUSA shall indemnify and hold STIEFEL and STIEFEL's Affiliates harmless from any and all [C.I.] resulting from [C.I.], if STIEFEL and its Affiliates have handled and stored such Product in accordance with its labelling; or (d) any [C.I.] of STIEFEL, its Affiliates or sub-distributors in connection with the sale and distribution of the Product. 14.2 By DUSA. DUSA hereby agrees to indemnify and hold STIEFEL and STIEFEL's Affiliates harmless from any and all [C.I.] arising from or in connection with any: Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (a) breach of the warranties by DUSA hereunder; (b) other misrepresentation or breach of this Agreement by DUSA or any [C.I.] of DUSA in connection with its contract obligations hereunder; (c) claim (expressed or implied) by DUSA or its Affiliates (except to the extent that such claim has been approved by the Regulatory Authority or authorized by STIEFEL) as to the efficacy or safety of the Product or the use to be made by any purchaser of the Product; provided that STIEFEL shall indemnify DUSA against and hold DUSA harmless from, any and all [C.I.] arising from STIEFEL's or its Affiliates' [C.I.] such Product in accordance with its labeling, if the Product meets all Specifications; (d) any [C.I.] of DUSA in connection with the manufacture, packaging, labeling and sale of Product to STIEFEL or its Affiliates. 14.3 Procedure for Indemnification. (a) If STIEFEL or any of its Affiliates or DUSA or any of its Affiliates (in each case an "INDEMNIFIED PARTY") receives any written claim which it believes is the subject of indemnity hereunder by DUSA or STIEFEL, as the case may be, (in each case as "INDEMNIFYING PARTY"), the Indemnified Party shall, as soon as reasonably practicable after forming such belief, give notice thereof to the Indemnifying Party, including full particulars of such claim to the extent known to the Indemnified Party; provided, that the failure to give timely notice to the Indemnifying Party as contemplated hereby shall not release the Indemnifying Party from any liability to the Indemnified Party. The Indemnifying Party shall have the right, by prompt notice to the Indemnified Party, to assume the defense of such claim with counsel reasonably satisfactory to the Indemnified Party, and at the cost of the Indemnifying Party. If the Indemnifying Party does not so assume the defense of such claim or, having done so, does not diligently pursue such defense, the Indemnified Party may assume such defense, with counsel of its choice, but for the account of the Indemnifying Party. If the Indemnifying Party so assumes such defense, the Indemnified Party may participate therein through counsel of its choice, but the cost of such counsel shall be for the account of the Indemnified Party. (b) The Party not assuming the defense of any such claim shall render all reasonable assistance to the Party assuming such defense, and all out-of-pocket costs of such assistance shall be for the account of the Indemnifying Party. (c) No such claims shall be settled other than by the Party defending the same, and then only with the consent of the other Party, which shall not be unreasonably withheld; provided, that the Indemnified Party shall have no obligation to consent to any settlement of any such claim which imposes on the Indemnified Party any liability or obligation which cannot be assumed and performed in full by the Indemnifying Party. 15. COMPLIANCE WITH LAW. 15.1 Compliance with Law. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (a) It shall be the responsibility of STIEFEL and DUSA, respectively, to follow all procedures and take all actions which are necessary or required for agreements of this type by the laws, treaties or regulations applicable in the country in which it is, respectively, manufacturing, selling or marketing the Product, in order to effect the intents and purposes of selling Product in the Territory under this Agreement. (b) It is further agreed that neither Party shall be obligated to carry out or to perform any terms of this Agreement if such term shall constitute a violation of any treaty, law, code or regulation of any governmental authority whether local, national or international. To the extent severable, the other terms of this Agreement that do not violate any treaty, law, code or regulation of any governmental authority whether local, national or international shall continue in full force and effect and the Parties shall use all reasonable efforts to re-negotiate and amend this Agreement so that the performance of this Agreement as so amended will not involve any such violation. 16. CONFIDENTIALITY; PUBLIC ANNOUNCEMENTS. 16.1 Non-Disclosure of Confidential Information. Each of the Parties agrees that it will not disclose any Confidential Information of the other Party that it may acquire at any time during the term of this Agreement without the prior written consent of such Party and that it shall use all reasonable efforts to prevent unauthorized publication or disclosure by any person of such Confidential Information including requiring its employees, consultants or agents to enter into similar confidentiality agreements in relation to such Confidential Information. 16.2 Term for Maintaining Confidential Information. The obligations undertaken by each Party under this Section 16 shall continue in force for a period of [C.I.] ([C.I.]) years following the termination or expiration of this Agreement. 16.3 Exception to Confidential Information. The obligations contained in this Section 16 do not apply to any information: (a) which was at the time of receipt by a Party in the public domain or generally known in the pharmaceutical manufacturing industry otherwise than by breach of a Party's duty of confidentiality; (b) which a Party can establish to have been known to it at the time of receipt from the other Party and not to have been acquired directly or indirectly from the other Party; (c) acquired by a Party from a Third Party otherwise than in breach of an obligation of confidence to the other Party; (d) required by law to be provided to governmental agencies but only for the purpose of providing it to such governmental agencies; and It is understood and agreed that each Party may disclose Confidential Information to those of its Affiliates that have a need to know such Confidential Information in order to perform the Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. obligations under this Agreement, and such Affiliates shall keep such information confidential to the same extent as required of a Party under this Agreement. Further each Party shall be fully responsible for its Affiliates' compliance with the confidentiality obligations hereunder. 16.4 Public Announcements. Except as required by law (including, without limitation, disclosure requirements of the United States Securities and Exchange Commission, the NASDAQ Stock Market or any other stock exchange on which securities issued by a Party or a Party's Affiliates are traded) neither Party shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other, which shall not be unreasonably withheld, provided that it shall not be unreasonable for a Party to withhold consent with respect to any public announcement containing any of such Party's Confidential Information. In the event a public announcement is required by law, to the extent practicable under the circumstances, the Party making such announcement shall provide the other Party with a copy of the proposed text not less than [C.I.] ([C.I.]) business days prior to such announcement to afford such other Party a reasonable opportunity to review and comment upon the proposed text. 17. AUDITS. 17.1 Regulatory Audit. Each Party shall have the right to audit the other Party's, and DUSA shall have the right to audit the STIEFEL's sub-distributors', facilities and records which directly relate to the Products in order to determine such other Party's compliance with Applicable Law and the terms of this Agreement. Such audit right shall include the right to access and review such records as well as the right to send reasonable numbers of representatives and agents to examine such facilities, provided all such representatives and agents execute and deliver to such other Party or sub-distributors, as applicable, confidentiality non-disclosure non-use agreements acceptable to such other Party or sub-distributors, as applicable, and all such examination of such facilities are conducted during normal business hours and with the minimum of disruption to ongoing operations. Except where any such audit is required to be undertaken by Applicable Law or in connection with the auditing Party's compliance therewith, such audits shall not take place more frequently than [C.I.] and the auditing Party shall give at least [C.I.] ([C.I.]) business days advance notice of the audit. In any case, any audit shall be conducted at such facilities and [C.I.], as applicable, shall [C.I.] incur in connection with the audit. Each Party, the sub-distributors, as applicable, and their respective affiliates shall permit and cooperate with Regulatory audits required to maintain Product Registrations in compliance with applicable laws and regulations within the Territory. 17.2 In the event of an audit by any Regulatory Authority, DUSA and STIEFEL each shall supply the other with a copy of any report received from such Regulatory Authority that pertains to the Product and its sale in the Territory and shall use its [C.I.] efforts to provide such Regulatory Authority with a prompt, accurate and complete response to any deficiencies noted during the audit. Both Parties agree to use their [C.I.] efforts to promptly address, and if necessary correct, any and all such deficiencies to the satisfaction of such Regulatory Authority. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. 18. TERM AND TERMINATION. 18.1 Term. This Agreement shall be for an initial term commencing as of the date of this Agreement and continuing until the tenth (10th) anniversary of the Effective Date (the "TERM"). STIEFEL shall have the option to extend the term of the Agreement for an additional [C.I.] ([C.I.]) year term upon the Parties reaching agreement in writing on the terms and conditions of such extension; provided that any such agreement shall incorporate the Minimum (annual) Purchase Requirements set forth on Schedule B. 18.2 Early Termination. This Agreement may be terminated in its entirety: (a) by notice in writing by either Party if the other Party shall default in the performance of any of its obligations under this Agreement and such default shall continue for a period of not less than [C.I.] ([C.I.]) days after written notice specifying such default shall have been given; provided, however, that if such default is not capable of being cured within such [C.I.] ([C.I.]) day period but the Party in default initiates and [C.I.] continues [C.I.] efforts to cure such default, such [C.I.] ([C.I.]) day period shall be extended to [C.I.] ([C.I.]) days; or (b) by either Party if the other Party makes an arrangement with its creditors or files bankruptcy, receivership or liquidation, or if a receiver or a receiver and manager is appointed in respect of the whole or a major part of the property or business of the Party in default; or (c) subject to Section 24.1, by either Party in [C.I.] of its voting securities or if [C.I.] of the other Party are disposed of or acquired by another person; or (d) by DUSA as set forth in Section 7.1(a)(ii) or Section 2.4(c); or (e) by STIEFEL as set forth in Section 2.4(b); or (f) by STIEFEL if [C.I.] during any calendar year are [C.I.] for that year; provided DUSA may, [C.I.], during regular business hours, upon giving reasonable prior written notice to STIEFEL audit or to have an independent professionally qualified auditor audit STIEFEL's records relative to sales of the Product in the Territory by STIEFEL and any sub-distributors solely in order to verify the number of units of Product sold to Third Parties; and provided further that nothing in this Agreement shall be deemed to obligate STIEFEL to discount Products below their approved prices; or (g) by DUSA if the average of the Purchase Price Per Unit, as expressed in U.S. Dollars using the then average daily applicable local currency / U.S. Dollar exchange rate on the date of each sale, for all sales to the Territory in any [C.I.] during the Term (the "Average Price") is [C.I.] U.S. Dollars (U.S.$[C.I.]), unless STIEFEL shall pay DUSA the difference between such Average Price and [C.I.] U.S. Dollars (U.S.$[C.I.]) for each unit sold during such [C.I.] within [C.I.] ([C.I.]) business days of DUSA giving STIEFEL notice under this Section 18.2(g). 18.3 Effects of Termination. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. (a) [C.I.] ([C.I.]) days after notice of termination has been given as herein provided, the right of STIEFEL to place orders for the Product with DUSA shall cease. (b) [C.I.], STIEFEL shall have the obligation to accept any Product in transit or subject to an accepted purchase order at the time of giving of written notice of termination. (c) DUSA shall not be responsible for [C.I.] Product after the termination or expiration of this Agreement, provided, that STIEFEL, may [C.I.] the Product for [C.I.] ([C.I.]) months following the termination of this Agreement. (d) Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. (e) All of the Parties' rights and obligations under Sections 2.3, 2.5(b) through (c) (inclusive), 3, 4.1(b), 4.2, 4.3, 4.5, 4.6, 8, and 10 through 29 (inclusive) shall survive termination, relinquishment or expiration of this Agreement. 19. FORCE MAJEURE. Neither Party shall be liable or be in breach of any provision of this Agreement for any failure or delay on its part to perform any obligation where such failure or delay has been occasioned by any act of God, war, riot, fire, explosion, flood, sabotage, unavailability of fuel, labor, containers or transportation facilities, accidents of navigation or breakdown or damage of vessels or other conveyances for air land or sea, other impediments or hindrances to transportation, government intervention (other than that of duly-authorized Regulatory Authority), strikes or other labor disturbances or any other cause beyond the control of the parties. 20. INSURANCE. DUSA and STIEFEL each shall maintain adequate product liability insurance [C.I.] to cover product liability claims against it, respectively, as manufacturer of the Product and distributor of the Product. 21. NOTICES. Notices provided under this Agreement to be given or served by either Party on the other shall be given in writing and served personally or by prepaid registered airmail post or by express mail or by means of facsimile to the following respective addresses or to such other addresses as the Parties may hereafter advise each other in writing. It being agreed and understood by the Parties that any such notice shall be deemed given and served the day transmitted by facsimile or a date three (3) days after the date of express mail or mail by courier. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. If to DUSA, to: DUSA Pharmaceuticals, Inc. 25 Upton Drive Wilmington, MA 01887 Attn: Bob Doman P: 978-909-2216 F: 978-909-1016 With a copy to: Nanette Mantell, Esq. Reed Smith LLP Princeton Forrestal Village 136 Main Street - Suite 250 Princeton, NJ 08543 P: 609-514-8542 F: 609-951-0824 If to STIEFEL, to: Stiefel Laboratories, Inc. 255 Alhambra Circle, Suite 1000 Coral Gables, Florida, USA 33134 Attn: Vice President - Area 2 P: 305-443-3800 F: 305-443-3467 And Attn: General Counsel P: 305-443-3800 F: 305-443-3467 22. EXECUTION OF ALL NECESSARY ADDITIONAL DOCUMENTS. Each Party agrees that it will forthwith upon the request of the other Party execute and deliver all such instruments and agreements and will take all such other actions as the other Party may reasonably request from time to time in order to effectuate the provision and purposes of this Agreement. 23. WAIVER. The failure of either of the Parties to insist upon a strict performance of any other terms and provisions therein shall not be deemed a waiver of any subsequent breach of default in the terms or provisions of this Agreement. 24. ASSIGNMENT AND AMENDMENT. 24.1 Non-assignability by STIEFEL and Binding Effect. A mutually agreed consideration for DUSA's entering into this Agreement is the reputation, business standing, and Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. goodwill already honored and enjoyed by STIEFEL under STIEFEL's present ownership, and, accordingly, STIEFEL agrees that STIEFEL's rights and obligations under this Agreement may not be transferred or assigned directly or indirectly without the prior written consent of DUSA. DUSA may freely assign and otherwise transfer this Agreement, or any right or obligation of DUSA hereunder, without obtaining the written consent of STIEFEL. Any attempted assignment not in accordance with this Section 24.1 shall be void. Subject to the foregoing in this Section 24.1, this Agreement shall be binding upon and inure to the benefit of the Parties hereto and their successors and assigns. 24.2 Amendment. No amendment hereof shall be binding unless made in writing and signed by the parties hereto. 25. ENTIRE AGREEMENT. This Agreement incorporates the entire understanding of the parties and revokes and supersedes any and all agreements, contracts, understandings or arrangements that might have existed heretofore between the parties regarding the subject matter hereof. 26. GOVERNING LAW; LANGUAGE. 26.1 Governing Law and Venue. This Agreement shall be construed in accordance with and governed by the internal laws of the [C.I.] without regard to conflict of laws principles. Any litigation arising from disputes regarding the subject matter of the Agreement shall be brought in United States federal court in the federal judicial district encompassing [C.I.]. The Parties will consent to venue and jurisdiction in such federal courts. 26.2 Language. The parties hereto agree that this Agreement shall be in the English language. 27. SEVERABILITY. If any term or provision of this Agreement shall be held invalid or unenforceable, the remaining terms hereof shall not be affected, but shall be valid and enforced to the fullest extent permitted by law. 28. HEADINGS. The headings used in this Agreement are intended for guidance only and shall not be considered part of this written understanding between the parties hereto. 29. INTERPRETATIVE RULES. For the purpose of this Agreement, except as otherwise expressly provided herein or unless the context otherwise requires: (a) defined terms include the plural as well as the singular and the use of any gender shall be deemed to include the other gender; (b) references to Articles, Sections and other subdivisions and to Schedules and Exhibits without reference to a document, Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. are to designated Articles, Sections and other subdivisions of and to Schedules and Exhibits to this Agreement; (c) the use of the term "including" means "including but not limited to"; and (d) the words "herein", "hereof", "hereunder" and other words of similar import refer to this Agreement in whole and not to any particular provision. * * * Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. IN WITNESS WHEREOF, this Agreement has been executed by the Parties on the date first above written. DUSA PHARMACEUTICALS, INC. By: /s/ Robert F. Doman ------------------------------------ Robert F. Doman President, Chief Operating Officer STIEFEL LABORATORIES, INC. By: /s/ Bresly F. Jaramillo ------------------------------------ Bresly F. Jaramillo Vice President Latin America Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. SCHEDULE A THE PRODUCT LEVULAN(R) KERASTICK(R): DUSA Trademarks: Levulan(R) Kerastick(R) DUSA(R) DUSA Pharmaceuticals, Inc.(R) Dosage Strength / Administration: 20% topical solution Competing Products: Any and all products [C.I.] the use of [C.I.] or [C.I.] any of the foregoing or [C.I.]. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. SCHEDULE B MINIMUM PURCHASE OBLIGATIONS The Minimum Purchase Obligations for Levulan(R) Kerastick(R) shall be as follows:
MINIMUM NUMBER TIME PERIOD OF UNITS ----------- -------------- First Time Period beginning on the earlier of (a) the [C.I.], or (b) [C.I.] units [C.I.], and in each case continuing for [C.I.] thereafter Second Time Period subsequent [C.I.] period following the end of the [C.I.] units First Time Period Third Time Period subsequent [C.I.] period following the end of the [C.I.] units Second Time Period Fourth Time Period subsequent [C.I.] period following the end of the [C.I.] units Third Time Period Fifth Time Period subsequent [C.I.] period following the end of the [C.I.] units Fourth Time Period Other subsequent time periods see below
For the remainder of the Term following the end of the Fifth Time Period, the Minimum Purchase Obligations for Levulan(R) Kerastick(R) shall be determined by [C.I.] no later than [C.I.] ([C.I.]) months prior to the end of the Fifth Time Period. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. SCHEDULE C SUPPLY PRICE AND [C.I.] OF SUPPLY ALL COUNTRIES IN THE TERRITORY "PURCHASE PRICE PER UNIT", with respect to units of the Product that are purchased for sale in a country in the Territory, shall mean [C.I.] Percent ([C.I.]%) of the final selling price to Third Parties in the applicable local currency which has been established by STIEFEL [C.I.] by STIEFEL on units of the Product sold. In the event at any time the Purchase Price Per Unit for sales to a country in the Territory in a given calendar quarter, as expressed in U.S. Dollars using the then current average daily applicable local currency / U.S. Dollar exchange rate, is [C.I.] U.S. Dollars (U.S.$[C.I.]) (the "Event"), then STIEFEL shall (a) [C.I.] in the applicable local currency [C.I.] of such Purchase Price Per Unit [C.I.] U.S. Dollars (U.S.$[C.I.]) or (b) otherwise pay to DUSA the [C.I.] price; provided that upon [C.I.] ([C.I.]) days prior written notice from STIEFEL given after such the Event, STIEFEL [C.I.]; provided further that upon giving such notice to DUSA, [C.I.] beginning [C.I.] and continuing until the [C.I.] U.S. Dollars (U.S.$[C.I.]) for a period of not less than [C.I.] ([C.I.]) weeks. Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission. SCHEDULE D FORM(S) OF REPORTS AND TIMING OF REPORTS
EX-21.A 5 y18270exv21wa.txt SUBSIDIARIES OF THE REGISTRANT EXHIBIT 21(a) SUBSIDIARIES OF DUSA PHARMACEUTICALS, INC. 1. DUSA Pharmaceuticals New York, Inc., a New York corporation. 2. DUSA Acquisition Corp., a New Jersey corporation. EX-23.A 6 y18270exv23wa.txt CONSENT OF DELOITTE & TOUCHE LLP EXHIBIT 23(a) CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in Registration Statement Nos. 333-73039, 333-84071, 333-31676, 333-33118 and 333-113913 on Form S-3 and Registration Statement Nos. 333-126345, 333-92259 and 333-57890 on Form S-8 of our reports dated March 10, 2006, relating to the financial statements of DUSA Pharmaceuticals, Inc. and management's report on the effectiveness of internal control over financial reporting appearing in this Annual Report on Form 10-K of DUSA Pharmaceuticals, Inc. for the year ended December 31, 2005. /s/ DELOITTE & TOUCHE LLP - -------------------------- Boston, Massachusetts March 10, 2006 EX-31.A 7 y18270exv31wa.txt CERIFICATION EXHIBIT 31(a) DUSA PHARMACEUTICALS, INC. CERTIFICATIONS I, D. Geoffrey Shulman, certify that: 1. I have reviewed this annual report on Form 10-K of DUSA Pharmaceuticals, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiary, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. Date: March 10, 2006 /s/ D. Geoffrey Shulman ------------------------------------ D. Geoffrey Shulman Chairman and Chief Executive Officer (principal executive officer) EX-31.B 8 y18270exv31wb.txt CERTIFICATION EXHIBIT 31(b) DUSA PHARMACEUTICALS, INC. CERTIFICATIONS I, Richard C. Christopher, certify that: 1. I have reviewed this annual report on Form 10-K of DUSA Pharmaceuticals, Inc.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiary, is made known to us by others within those entities, particularly during the period in which this report is being prepared; b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and 5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and b) Any fraud, whether or not material, that involves management or other employees who have a significant b role in the registrant's internal control over financial reporting. Date: March 10, 2006 /s/ Richard C. Christopher --------------------------------------------------- Richard C. Christopher Vice President, Finance and Chief Financial Officer (principal financial officer) EX-32.A 9 y18270exv32wa.txt CERTIFICATION EXHIBIT 32(a) CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the annual report of DUSA Pharmaceuticals, Inc. (the "Company") on Form 10-K for the year ended December 31, 2005, as filed with the Securities and Exchange Commission (the "Report"), I, D. Geoffrey Shulman, Chairman and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: 1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and 2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: March 10, 2006 /s/ D. Geoffrey Shulman ------------------------------------- D. Geoffrey Shulman Chairman and Chief Executive Officer (principal executive officer) EX-32.B 10 y18270exv32wb.txt CERTIFICATION EXHIBIT 32(b) CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the annual report of DUSA Pharmaceuticals, Inc. (the "Company") on Form 10-K for the year ended December 31, 2005, as filed with the Securities and Exchange Commission (the "Report"), I, Richard C. Christopher, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that: 1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and 2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Date: March 10, 2006 /s/ Richard C. Christopher ------------------------------------------- Richard C. Christopher Vice President, Finance and Chief Financial Officer (principal financial officer)
-----END PRIVACY-ENHANCED MESSAGE-----