-----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, I2zXAb8C5n3ar3nGulDyn+xhlD/Qb7SgIxdRoE7UQwCZP9Pyh6FbeRxfuXqFo6OG sK6D8bnMkOWvCrPR0/GxAQ== 0000898430-01-000747.txt : 20010224 0000898430-01-000747.hdr.sgml : 20010224 ACCESSION NUMBER: 0000898430-01-000747 CONFORMED SUBMISSION TYPE: 10KSB PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20001231 FILED AS OF DATE: 20010222 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PROTEIN POLYMER TECHNOLOGIES INC CENTRAL INDEX KEY: 0000858155 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 330311631 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10KSB SEC ACT: SEC FILE NUMBER: 000-19724 FILM NUMBER: 1552268 BUSINESS ADDRESS: STREET 1: 10655 SORRENTO VALLEY RD CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6195586064 MAIL ADDRESS: STREET 1: 10655 SORRENTO VALLEY ROAD CITY: SAN DIEGO STATE: CA ZIP: 92121 10KSB 1 0001.txt ANNUAL REPORT ================================================================================ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-KSB (Mark One) [X] ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2000 OR [_] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to_________ Commission file number 0-19724 PROTEIN POLYMER TECHNOLOGIES, INC. (Exact name of small business issuer as specified in its charter) Delaware 33-0311631 (State or Other Jurisdiction of (IRS Employer Incorporation or Organization) Identification No.) 10655 Sorrento Valley Road, San Diego, CA 92121 (Address of Principal Executive Offices) Issuer's Telephone Number: (858) 558-6064 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock (Title of Class) Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No -------- -------- Check if there is no disclosure of delinquent filers pursuant to Item 405 of Regulation S-B contained herein, and no disclosure will be contained, to the best of the registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB. [ ] The issuer's revenues for the most recent fiscal year were $1,189,495. The aggregate market value of the voting stock held by non-affiliates of the issuer on February 16, 2001 was $6,935,027. State the number of shares outstanding of each of the issuer's classes of common equity, as of the latest practicable date: As of February 16, 2001, 18,910,313 shares of common stock were outstanding. DOCUMENTS INCORPORATED BY REFERENCE: Definitive Proxy Statement to be filed no later than April 30, 2001 pursuant to Regulation 14A with respect to the Registrant's 2001 Annual Meeting of Stockholders (incorporated by reference in Part III). Transitional Small Business Disclosure Format: Yes No X ----- ----- ================================================================================ PROTEIN POLYMER TECHNOLOGIES, INC. FORM 10-KSB FOR THE FISCAL YEAR ENDED DECEMBER 31, 2000 TABLE OF CONTENTS
Page No. -------- PART I...................................................................... 2 Item 1. Business....................................................... 2 Item 2. Properties..................................................... 18 Item 3. Legal Proceedings.............................................. 18 Item 4. Submission of Matters to a Vote of Security Holders............ 18 PART II..................................................................... 19 Item 5. Market for Common Equity and Related Stockholder Matters............................................ 19 Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operations.......................................... 22 Item 7. Financial Statements........................................... F-1 Item 8. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure........................................... 27 PART III.................................................................... 27 Items 9, 10, 11 and 12 - Incorporated by Reference Item 13. Financial Statements, Exhibits and Reports on Form 8-K......... 27 Signatures................................................................ 33
1 PART I Item 1. Business Company Background Protein Polymer Technologies, Inc., a Delaware corporation ("PPTI") is a development-stage biotechnology company incorporated on July 6, 1988 and is engaged in the research, development, production and clinical testing of medical products based on its proprietary protein-based biomaterials technology. Since 1992, we have focused primarily on developing materials technology and products to be used in the surgical repair of tissue: surgical adhesives and sealants; soft tissue augmentation products; wound healing matrices; drug delivery formulations; and surgical adhesion barriers. We have also developed coating technology that can efficiently modify and improve the surface properties of more traditional biomedical devices. A common goal is to develop materials that beneficially interact with human cells, enabling cell growth and the regeneration of tissues with improved outcomes as compared to current products and practices. We began studies to identify our most promising biomaterial formulations for use in soft tissue augmentation products in 1996. We devoted increased resources to the program through 1997 and 1998, and with promising preclinical test results, we focused on preparations for human clinical testing in 1999. In December 1999, we initiated human clinical testing of our urethral bulking agent for the treatment of female stress urinary incontinence. This pilot clinical study is ongoing. The Investigational Device Exemption ("IDE") approved by the U.S. Food and Drug Administration ("FDA") allows us to test the safety and effectiveness of the incontinence product in women over the age of 40 who have become incontinent due to the shifting of their bladder or the weakening of the muscle at its base that controls the flow of urine, or both problems combined. We estimate that more than 2.5 million women begin to experience stress urinary incontinence in the United States each year. In most untreated cases, the problem becomes progressively more pronounced. Due to limited efficacy or invasiveness of current treatments, only a small proportion of the women experiencing stress urinary incontinence are clinically treated, relying instead on pads and plugs and the like that only address the symptoms. In contrast, our product is injected, typically in an out patient procedure, into urethral tissue at the base of the bladder forming a solid implant that provides support to the muscles controlling the flow of urine. We believe that our product, if approved, will prove to be easy for the physician to use, offer enduring effectiveness, and avoid most of the other limitations of urethral bulking products on the market or in development. In January 2000, we established a strategic alliance with Femcare, Ltd. ("Femcare") for the commercialization of the incontinence product in Europe and Australia. In the agreement, Femcare is responsible for clinical testing, regulatory approval, and product sales and marketing within these territories, and we are responsible for product manufacturing. Contingent on successful clinical trials, commercialization of the product in Europe is expected to begin more than a year before approval for marketing the product in the United States could be obtained. 2 The soft tissue augmentation materials and technology underlying the incontinence product have the potential to be effective and desirable in a number of other clinical applications. In November 2000, the FDA approved our IDE to begin human clinical testing of a tissue augmentation product for use in cosmetic and reconstructive surgery applications. The product is injected into or under the skin for the correction of contour deficiencies (facial lines, wrinkles, scars, etc.) caused by aging or disease. We expect to initiate our pilot clinical study for this application in the first quarter of 2001 to the extent resources are available. We estimate that approximately 350,000 cosmetic tissue augmentation procedures using injected materials (e.g. collagen, fat) were performed in the U.S in 1998, having grown over 20% compared to 1996. With a product demonstrating greater durability than currently available materials, we believe the number of procedures could grow dramatically. Between 1994 and 1997, our efforts were focused predominantly on the development of surgical adhesive and sealant technology. As part of this effort, we targeted the establishment of a strategic alliance with a market leader in the field of surgical wound closure products which led to the execution of comprehensive license, supply and development agreements in September 1995, with Ethicon, Inc. ("Ethicon"), a subsidiary of the Johnson & Johnson Company ("J&J"). Ethicon elected to terminate these agreements in December 1997. We have demonstrated both the adhesive performance and the biocompatibility of our product formulations in animal models, including the resorption of the adhesive matrix in conjunction with the progression of wound healing. We are committed to the commercial development of our adhesive and sealant technology. Subsequent to the termination of the Ethicon agreement, we have worked to determine the most significant market and product opportunities for its use. We are seeking to establish new strategic alliances with leaders in those markets. Our cash balance as of December 31, 2000 was $866,000. We believe this amount is sufficient to fund operations through March 2001. Substantial additional capital resources will be required to fund continuing expenditures related to our research, development, manufacturing and business development activities. We believe there may be a number of alternatives available to meet the continuing capital requirements of our operations, such as collaborative agreements and public or private financings. During 2001, we expect that the possible exercise of other existing warrants could result in additional funds for continuing operations. Further, we are currently in preliminary discussions with a number of potential collaborative partners and, based on the results of various materials evaluations, funding in the form of license fees, milestone payments or research and development reimbursements could be generated. There can be no assurance that any of these fundings will be consummated in the necessary timeframes needed for continuing operations or on terms favorable to us. If adequate funds are not available, we will be required to significantly curtail our operating plans and may have to sell or license out significant portions of our technology or potential products. (See the Liquidity and Capital Resources section of Management's Discussion and Analysis of Financial Condition and Results of Operations for further discussion.) 3 To the extent sufficient resources are available, we continue to research the use of our protein polymers for other tissue repair and medical device applications, principally for use in tissue engineering matrices and drug delivery devices. Through 1999, we marketed specialty use products for in vitro cell culture applications including SmartPlastic/(R)/ and ProNectin/(R)/ F Cell Attachment Factor. ProNectin F was launched commercially in 1991. SmartPlastic is ProNectin F Activated Cultureware where ProNectin F is presented in ready to use form on the surfaces of disposable plastic labware for culturing human and animal cells. SmartPlastic was launched commercially in 1995. In 1998 we discontinued direct sales of our cell culture products, and in February 2000, we sold all rights to the use of the technology for in vitro cell culture applications, the product trademarks, and remaining inventory to Sanyo Chemical Industries, Ltd. Prior to 1992, our scientists had successfully demonstrated the ability to create and produce novel protein polymer materials having important physical, biological and chemical properties. During this period, most of the our efforts were dedicated to supplying E. I. DuPont de Nemours & Co. ("DuPont") with materials under contract for DuPont's proprietary research and testing purposes. Technology We are focused on developing products to improve medical and surgical outcomes, based on an extensive portfolio of proprietary biomaterials. Biomaterials are materials that are used to direct, supplement, or replace the functions of living systems. The interaction between materials and living systems is dynamic. It involves the response of the living system to the materials (e.g., biocompatibility) and the response of the materials to the living system (e.g., degradation). The requirements for performance within this demanding biological environment have been a critical factor in limiting the myriad of possible metal, polymer, and ceramic compositions to a relatively small number that to date have been proven useful in medical devices. The goal of biomaterials development historically has been to produce inert materials, i.e., materials that elicit little or no response from the living system. However, we believe that such conventional biomaterials are constrained by their inability to convey appropriate messages to the cells that surround them, the same messages that are conveyed by proteins in normal human tissues. The products we have targeted for development are based on a new generation of biomaterials which have been designed to be recognized and accepted by human cells, to aid in the natural process of bodily repair (including the healing of tissue and the restoration or augmentation of its form and function), and, ultimately, to promote the regeneration of tissues. We believe that the successful realization of these properties will substantially expand the role that artificial devices can play in the prevention and treatment of human disability and disease, and enable the culture of native tissues for successful reimplantation. Through our proprietary core technology, we produce high molecular weight polymers that can be processed into a variety of material forms such as gels, sponges, films, and fibers, with their physical strength and rate of resorption tailored to each potential product application. 4 These polymers are constructed of the same amino acids as natural proteins found in the body. We have demonstrated that our polymers can mimic the biological and chemical functions of natural proteins and peptides, such as the attachment of cells through specific membrane receptors and the ability to participate in enzymatic reactions, thus overcoming a critical limitation of conventional biomaterials. In addition, materials made from our polymers have demonstrated excellent biocompatibility in a variety of preclinical feasibility studies. Our patented core technology enables messages that direct activities of cells to be precisely formulated and presented in a structured environment similar to what nature has demonstrated to be essential in creating, maintaining and restoring the body's functions. Our protein polymers are made by combining the techniques of modern biotechnology and traditional polymer science. The techniques of biotechnology are used to create synthetic genes that direct the biological synthesis of protein polymers in recombinant microorganisms. The methods of traditional polymer science are used to design novel materials for specific product applications by combining the properties of individual "building block" components in polymer form. In contrast to natural proteins, either isolated from natural sources or produced using traditional genetic engineering techniques, our technology results in the creation of new proteins with unique properties. We have demonstrated an ability to create materials that: . combine properties of different proteins found in nature; . reproduce and amplify selected activities of natural proteins; . eliminate undesired properties of natural proteins; and . incorporate synthetic properties via chemical modifications. This ability is fundamental to our current primary product research and development focus -- tissue repair and regeneration. Tissues are highly organized structures made up of specific cells arranged in relation to an extracellular matrix ("ECM"), which is principally composed of proteins. The behavior of cells is determined largely by their interactions with the ECM. Thus, the ability to structure the cells' ECM environment allows the protein messages they receive -- and their activity -- to be controlled. Similar to what nature has demonstrated to be essential in creating, maintaining and restoring the body's functions, our patented core technology enables messages that direct activities of cells to be precisely formulated and presented in a structured environment. Fundamental Protein Polymers PPTI's primary products under development are based on protein polymers combining selected properties from two of the most extraordinary structural proteins found in nature: silk and elastin. Silk, based upon its crystalline structure, has long been known as an incredibly strong material, and has a long history of medical use in humans as a material for sutures. Elastin fibers are one of the most remarkable rubber-like materials ever studied. Found in human tissues such as skin, lungs and arteries, elastin fibers must expand and contract over a life time, and can be extended nearly three times their resting length without damaging their flexibility. Despite the incredible individual properties of silk and elastin, neither of these natural protein materials is capable of being processed into forms other than what nature has provided 5 without destroying their valuable materials properties. However, our proprietary technology has enabled the creation of polymers that combine the repeating blocks of amino acids responsible for the strength of silk and the elasticity of elastin. By precisely varying the number and sequence of the different blocks in the assembled protein polymer, new combinations of properties suitable for various medical applications have been created. We have also created protein polymers based on repeating blocks of amino acids found in two other classes of structural proteins found in nature: collagen and keratin. Collagen is the principal structural component of the body, found in some shape or form in virtually every tissue, ranging from shock absorbing cartilage to light transmitting corneas. Keratin is a major component in hair, nails and skin. The development of materials based on these polymers is at an early stage of research. Product Candidates and Anticipated Markets Our technology and materials have the potential to create products and product applications in a variety of medical and specialty use markets. Our current development efforts are principally focused on preparations for scale-up and validation of manufacturing processes for our hydrogel bulking agents for soft tissue augmentation. However, opportunities for research and development of product candidates for other medical and specialty use continue to be evaluated, particularly those based on our tissue adhesive and sealant technology. All of our product candidates are subject to preclinical and clinical testing requirements for obtaining U.S. Food and Drug Administration's ("FDA's") marketing approval. The actual development of product candidates, if any, will depend on a number of factors, including the availability of funds required to research, develop, test and obtain necessary regulatory approvals; the anticipated time to market; the potential revenues and margins that may be generated if a product candidate is successfully developed and commercialized; and the Company's assessment of the potential market acceptance of a product candidate. Soft Tissue Augmentation Conditions where there is a need to augment the body's soft tissues include both cosmetic and medical applications. In the former, for example, current procedures include the injection of collagen-based materials to smooth out facial wrinkles, acne scars and to modify lip contours. However, these treatments only last a matter of months, which puts them economically out of reach for a large portion of the population of people who would otherwise desire the procedure. Medical applications include the treatment of stress urinary incontinence, gastroesophageal reflux, fecal incontinence, the reversible blockage of fallopian tubes for birth control, the augmentation of vocal chords, and the expansion of gingival tissues impacted by periodontal disease. We believe there is a lack of materials with suitable properties for these applications, primarily because materials having the required durability in vivo either lack the requisite biocompatibility or the ability to be easily injected. We have developed protein polymers that demonstrate excellent biocompatibility, are soluble in water at room temperature, and are easily injected into body tissues, irreversibly 6 forming soft, durable gels at body temperature. Previously, we have shown gels of similar composition to persist at least 18 months in an animal model. Our bulking agents are unique in that they are applied as an aqueous solution, easily injected through a 30-gauge needle, rapidly spreading throughout the native tissue architecture. With the increase from room to body temperature, the polymer solution irreversibly transforms within minutes to a soft, pliable hydrogel. Importantly, the volume of material remains constant in the liquid to gel transition, such that the tissue expansion observed by the physician upon administration will be subsequently maintained. This is in direct contrast to the majority of competing technologies, which are suspensions or slurries of solid particles in an aqueous carrier such as saline. When injected through a fine gauge needle, with some difficulty due to their thick constitution, the carrier liquid dissipates through the tissues with time, usually within 24 hours, such that roughly half of the effective bulking volume is lost. This requires the physician to either overcompensate for the expected volume reduction upon initial administration, with increased risks to the patient, or to "top off" the bulking effect with repeated administrations of the product over time, with substantially increased costs. Other hydrogel technologies of which we are aware are either preformed gels, difficult to administer by injection, or polymer solutions mixed with a chemical cross-linking agent prior to injection. We believe that such technologies are limited in their overall performance including durability, biocompatibility and ease of administration. In August 1999, we obtained the FDA's approval of our Investigational Device Exemption ("IDE") to begin human clinical testing of our urethral bulking agent for the treatment of female stress urinary incontinence. We began pilot clinical testing of the product's safety and efficacy in December 1999. We project expanding into a multi-site pivotal clinical study in the first quarter of 2002 to the extent resources are available. In November 2000, we obtained the FDA's approval of our IDE to begin human clinical testing of a tissue augmentation product for use in cosmetic and reconstructive surgery applications. The product is injected into or under the skin for the correction of contour deficiencies (facial lines, wrinkles, scars, etc.) caused by aging or disease. We expect to initiate our pilot clinical study for this application in the first quarter of 2001, potentially expanding into a multi-site pivotal clinical study also in the first quarter of 2002 to the extent resources are available. Surgical Adhesives and Sealants Certain surgical adhesives and sealants that seek to avoid the limitations of sutures, staples, pins and screws have been developed and marketed outside the United States by other parties. In 1998, the FDA approved two such products for certain uses in the U.S. DermaBond(TM), a cyanoacrylate adhesive, was approved for topical application to close skin incisions and lacerations. Cyanoacrylate adhesives set fast and have high strength, but are toxic to certain tissues and form brittle plastics that do not resorb. These limitations restrict their use to bonding the outer surfaces of skin together. Tisseel(TM), a fibrin sealant, was approved for use as an adjunct 7 to hemostasis in surgery. Fibrin sealants have excellent hemostatic properties, but are derived from human and/or animal blood products, set slowly, have low strength, and lose their strength rapidly. A third category of tissue adhesives combines natural proteins such as collagen or albumin with aldehyde cross-linking agents. Such products are marketed in Europe for limited life-threatening indications. The aldehyde cross- linking agents employed (i.e. glutaraldehyde, formaldehyde) in such products are known to cause adverse tissue reactions. Additional adhesive and/or sealant products employing other polymer systems and cross-linking agents are also under development. We are seeking to develop surgical adhesives and sealants that combine the biocompatibility of fibrin glues (without the risks associated with use of blood-derived products) with the high strength and fast setting times of cyanoacrylates. Unique features include significant elasticity within the adhesive matrix (to move as tissues move) and the capability of tailoring the resorption rate of the adhesive matrix with the rate at which the wound heals. A non-resorbable adhesive or sealant can only be used where the damaged tissues will not heal. Otherwise, a barrier to wound healing is unavoidably created. In September 1995, we entered into a series of agreements with Ethicon regarding this program. Ethicon elected to terminate these agreements in December 1997. However, we had previously demonstrated both the adhesive performance and the biocompatibility of our product formulations in animal models, including the resorption of the adhesive matrix in conjunction with the progression of wound healing. Subsequently, we have worked to determine the specific markets and products providing the most significant opportunities for the use of our adhesive and sealant technology. As a result of our evaluations of the medical market needs, the properties achievable with our technology, and the capabilities of competitive technologies, we have focused our product development interests on certain orthopedic applications, particularly those related to the repair of the spinal disc for the treatment of chronic low back pain. Low back pain is the most common musculoskeletal disorder in industrialized societies. We are committed to the commercial development of our adhesive and sealant technologies and are seeking to establish new strategic alliances with market leaders. However, there can be no assurance that such alliances will be entered into. Wound Healing/Tissue Engineering Matrices The current market for wound care products is highly segmented, involving a variety of different approaches to wound care. Products currently marketed and being developed by other parties include fabric dressings (such as gauze), synthetic materials (such as polyurethane films) and biological materials (such as growth factors and living tissue skin graft substitutes). While the type of product used varies depending on the type of wound and extent of tissue damage, we believe that a principal treatment goal in all instances is to stimulate wound healing while regenerating functional (as opposed to scar) tissue. 8 We have developed protein polymers which we believe may be useful in the treatment of dermal wounds, particularly chronic wounds such as decubitous ulcers, where both reconstruction of the ECM and re-establishment of its function are desired. These polymers, based on key ECM protein sequence blocks, are biocompatible, fully resorbable and have been processed into gels, sponges, films and fibrous sheets. We believe that such materials, if successfully developed, could improve the wound-healing process by providing physical support in situ for cell migration and tissue regeneration and as delivery systems for growth factors. Additionally, such materials may serve as scaffolds for the ex vivo production of living tissue substitutes. This program is in the early stages of research, which we have principally conducted in collaboration with third parties. Such collaborations have primarily focused on the treatment of dermal wounds. Controlled Release Drug Delivery Oral delivery of drugs is the most preferred route of administration. However, for many drugs this is not possible and alternative drug delivery routes are required. Alternative routes include transdermal, mucosal, and by implantation or injection. For implantation or injection, it is often desirable to extend the availability of the drug in order to minimize the frequency of these invasive procedures. A few materials have been commercialized which act as depots for a drug when implanted or injected, releasing the drug over periods ranging from one month to several years. Other material and drug combinations are being developed by third parties. We believe that the properties of these materials for such applications can be substantially improved upon, making available the use of depot systems for a wider range of drugs and applications. Our soft tissue augmentation products, wound healing matrices, and medical device coating technology all provide platforms for drug delivery applications, serving as controlled release drug depots. The protein polymer materials we have developed exhibit exceptional biocompatibility, provide for control over rates of resorption, and are fabricated using aqueous solvent systems at ambient temperatures -- attributes which can be critical in maintaining the activity of the drug, particularly protein-based drugs emerging from the biotechnology industry. This program is in the early stages of research. Manufacturing, Marketing and Distribution Preclinical and clinical testing of potential medical device products, where the results will be submitted to the FDA, requires compliance with the FDA's Good Laboratory Practices ("GLP") and other Quality System Regulations ("QSR"). We have implemented, and continue to implement, polymer production and quality control procedures, and have made certain facilities renovations to operate in conformance with FDA requirements. We believe our current polymer production capacity is sufficient for supplying our development programs with the required quality and quantity of materials needed for feasibility and preclinical testing and initial ("pilot") clinical testing. To expand beyond initial clinical trials, we will require additional manufacturing capacity. 9 We are considering several methods for increasing production of our biomedical and other product candidates to meet clinical and commercial requirements. For example, we may expand our existing facility to produce needed quantities of materials under FDA's GLP and QSR regulations for clinical and commercial use. Alternatively, we may establish external contract manufacturing arrangements for needed quantities of materials. However, there can be no assurance that such arrangements, if desired, could be entered into or maintained on acceptable terms, if at all, or that the existence or maintenance of such arrangements would not adversely affect the our margins or our ability to comply with applicable governmental regulations. The actual method, or combination of methods, that we may ultimately pursue will depend on a number of factors, including availability, cost and our assessment of the ability of such production methods to meet our commercial objectives. We have entered into an agreement with Femcare for marketing and distribution of our urethral bulking agent for stress urinary incontinence in certain countries, if the required regulatory approvals are obtained. We currently expect that our other biomedical products, if any were commercialized, would be marketed and distributed by corporate partners. While this arrangement could minimize our marketing costs and facilitate wider distribution of any biomedical products we may develop, these arrangements could possibly reduce our revenues and profits as compared to what would be possible if we directly sold such products. Research and Development Information regarding Company-sponsored research and development activities and contract research and development revenue is set forth below under the heading "Management's Discussion and Analysis of Financial Condition and Results of Operations". Collaborative Agreements Because of the highly technical focus of our business, we must conduct extensive research and development prior to any commercial production of our biomedical products or the biomaterials from which they are created. During this development stage, our ability to generate revenues is limited. Because of this limitation, we do not have sufficient resources to devote to extensive testing or marketing of our products. Our primary method to expand our product development, testing and marketing capabilities is to seek to form collaborative arrangements with selected corporate partners with specific resources that we believe complement our business strategies and goals. The medical device industry has traditionally licensed from development stage companies product candidates whose safety and efficacy has been demonstrated at least in pilot human clinical trials. In December 1999, we began human clinical testing of our urethral bulking agent for the treatment of female stress urinary incontinence. We intend to begin human clinical testing of a tissue augmentation product for use in cosmetic and reconstructive surgery applications in the first quarter of 2001 to the extent resources are available. 10 Genencor International In December 2000, we announced the signing of a broad-based, worldwide exclusive license agreement with Genencor International, Inc. ("Genencor") enabling Genencor to potentially develop a wide variety of new products for industrial markets. As a result of the agreement, Genencor can use our patented protein polymer design and production technology, in combination with Genencor's extensive gene expression, protein design, and large-scale manufacturing technology, to design and develop new products with improved performance properties for defined industrial fields. We retain all rights to the technology for use in medical products. In return for the licensed rights, Genencor paid to us an upfront license fee of $750,000, and will pay royalties on the sale of products commercialized by Genencor under the agreement, if any. In addition, we may receive up to $5 million in milestone payments associated with the achievement of various product development milestones. We may provide certain funded R&D services to Genencor if negotiated in a separate agreement at a later date. Genencor received warrants to acquire up to $1 million of our common stock. Femcare, Ltd. In January 2000, we announced the formation of a strategic alliance with Femcare, Ltd. for the commercialization in Europe and Australia of our urethral bulking agent for treatment of stress urinary incontinence. Femcare is a British-based developer and international marketer of surgical products for gynecological and urological applications. In the alliance, we will provide Femcare with technical assistance, and the incontinence product for Femcare's clinical testing and regulatory approvals in the Femcare territories. Femcare will utilize its existing customer base and its extensive distribution network as the basis for introducing the product into Europe and Australia. Currently, Femcare markets its products in 40 countries worldwide. A Urology division has been created to extend the company's success in gynecology to urological applications, in particular, female stress urinary incontinence. We received a $1 million license fee and will receive a royalty on the revenues generated by Femcare from the sale of the product. We will be responsible for providing the product to Femcare for clinical testing and commercial sale, or with providing Femcare with the necessary know-how to arrange its own manufacturing. Other Agreements We are discussing other potential collaboration agreements with prospective marketing partners for both our soft tissue augmentation products and our tissue adhesive and sealant products. There can be no assurance that we will continue such discussions or be able to establish such agreements at all, or do so in a timely manner and on reasonable terms, or that such agreements will lead to successful product development and commercialization. From time to time, we are party to certain materials evaluation agreements regarding biomedical and specialty use applications of our products, polymers and technology, including applications in areas other than those identified as product candidates above. These agreements provide, or are intended to provide, for the evaluation of product feasibility. There can be no assurance that we will continue to be able to establish such agreements at all, or do so in a timely manner and on reasonable 11 terms, or that such agreements will lead to joint product development and commercialization agreements. Intense Competition The principal anticipated commercial uses of our biomaterials are as components of end-use products for biomedical and other specialty applications. End-use products using or incorporating our biomaterials would compete with other products that rely on the use of alternative materials. For example, bulking agents for soft tissue augmentation are currently marketed based on bovine and human cadaver collagen and, outside the U.S., silicone particles and other synthetic materials. Similarly, all targeted applications of our potential products will compete with other products having the same or similar applications. The areas of business in which we engage and propose to engage are characterized by intense competition and rapidly evolving technology. Competition in the biomedical and surgical repair markets is particularly significant. Our competitors in the biomedical and surgical repair markets include major pharmaceutical, surgical product, chemical and specialized biopolymer companies, many of which have financial, technical, research and development and marketing resources significantly greater than ours. Academic institutions and other public and private research organizations are also conducting research and seeking patent protection in the same or similar application areas, and may commercialize products on their own or through joint ventures. Most of our competitors depend on synthetic polymer technology rather than protein engineering for developing products. However, we believe that DuPont and several university laboratories are currently conducting research into similar protein engineering technology. The primary elements of competition in the biomedical and surgical repair products market are performance, cost, safety, reliability, convenience and commercial production capabilities. We believe that our ability to compete in this market will be enhanced by our issued patent claims, the breadth of our other pending patent applications, our early entry into the field and our experience in protein engineering. Patents and Trade Secrets We are aggressively pursuing domestic and international patent protection for our technology, making claim to an extensive range of recombinantly prepared structural and functional proteins, methods for preparing synthetic repetitive DNA encoding these proteins, methods for the production and purification of protein polymers, end-use products incorporating such materials and methods for their use. The United States Patent and Trademark Office ("USPTO") has issued twenty patents to us. U.S. Patent 5,235,041 (1993) relates to our method for purifying structurally ordered recombinant protein polymers. U.S. Patent 5,243,038 (1993) covers our synthetic DNA compositions that encode polymers and copolymers comprising the amino acid "building blocks" of silk and elastin. U.S. Patent 5,496,712 (1996) covers our family of high molecular weight collagen like polymers and the DNA sequences encoding them. U.S. Patent 5,514,581 (1996) covers DNA sequences encoding silk-like structural building blocks with an intervening 12 sequence coding for the key cell attachment ligand from human fibronectin. One of the claimed sequences encodes ProNectin F. U.S. Patent 5,606,019 (1997) covers the protein compositions comprising copolymers of the amino acid "building blocks" of silk and elastin. These are the primary materials used in our current product development efforts. U.S. Patent 5,641,648 (1997) covers methods by which synthetic genes encoding protein polymers are created. U.S. Patent 5,723,588 (1998) covers molded articles incorporating biologically active proteins. U.S. Patent 5,760,004 (1998) covers chemically modified protein polymers with enhanced water solubility. U.S. Patent 5,770,697 (1998) broadly covers protein polymers incorporating repetitive amino acid sequences found in naturally occurring proteins. U.S. Patent 5,773,249 (1998) expands the coverage of high molecular weight collagen like polymers. U.S. Patent 5,773,577 (1998) covers protein polymers that can be cross-linked by certain enzymes that naturally occur in the body. U.S. Patent 5,808,012 (1998) expands the coverage of molded articles to those incorporating chemically active proteins. U.S. Patent 5,817,303 (1998) covers the use of protein polymers with chemical cross-linking agents as adhesives and sealants, key to our product development for the repair of spinal discs. U.S. Patent 5,830,713 (1998) expands the coverage of methods by which synthetic genes encoding protein polymers are created. U.S. Patent 6,015,474 (2000) covers methods and compositions useful for enhancing the performance of tissue adhesives and sealants. U.S. Patent 6,018,030 (2000) broadly covers DNA sequences encoding protein polymers incorporating repetitive amino acid sequences found in naturally occurring proteins. U.S. Patent 6,033,654 (2000) covers cross-linked protein compositions (adhesives and sealants). U.S. Patent 6,034,022 (2000) covers methods for preparing chemically modified protein polymers with enhanced water solubility. U.S. Patent 6,140,072 (2000) broadly covers DNA sequences encoding protein polymers incorporating intervening sequences providing functional properties (e.g. biological or chemical activity). U.S. Patent 6,184,348 (2001) broadly covers protein polymers incorporating intervening sequences providing functional properties (e.g. biological or chemical activity). Additionally, we have four U.S. patent applications pending, covering related aspects of our core technology. Although we believe our existing issued patent claims provide a competitive advantage, there can be no assurance that the scope of our patent protection is or will be adequate to protect our technology or that the validity of any patent issued will be upheld in the future. Additionally, with respect to our pending applications, there can be no assurance that any patents will be issued, or that, if issued, they will provide substantial protection or be of commercial benefit to us. The two patents issued to PPTI in 1993 will expire in 2010, as will one of the patents issued in 1996. The other patent issued in 1996 will expire in 2013, and the patents issued in 1997 will expire in 2014. The three patents issued in 1998, which expand the coverage of previously issued patents, will expire in concert with the original patents. The other five patents issued in 1998 will expire in 2015. Three patents issued in 2000 expand upon the claims of previously issued patents and will expire in concert with the original patents (one in 2010 and two in 2015). The other two patents issued in 2000 will expire in 2017 and 2018, the difference due to the date each 13 application was filed. The patent issued in 2001 expands upon the claims of a previously issued patent and will expire in 2015. Although we do not currently have any operations outside the U.S., we anticipate that our potential products will be marketed on a worldwide basis, with possible manufacturing operations outside the U.S. For example, we have recently established a licensing and distribution agreement with Femcare Ltd. for the sale of our urethral bulking agent in Europe and Australia. Accordingly, international patent applications corresponding to the major U.S. patents and patent applications described above have been filed in these and other important market jurisdictions. Due to translation costs and patent office fees, international patents are significantly more expensive to obtain than U.S. patents. Additionally, there are differences in the requirements concerning novelty and the types of claims that can be obtained compared to U.S. patent laws, as well as the nature of the rights conferred by a patent grant. We carefully consider these factors in consultation with our patent counsel, as well as the size of the potential markets represented, in determining the foreign countries in which to file patents. In almost all cases, we file for patents in Europe and Japan. Currently, we have fourteen issued foreign patents, and twenty-five pending foreign applications. One of the issued foreign patents is in Europe and the scope of its claims broadly covers protein polymers having biological or chemical activity. In order to reduce our patent-related expenses, we are currently implementing a policy of only maintaining foreign patents or applications in Europe and Japan, unless required due to our license agreements. This has resulted in our abandoning issued, allowed and pending foreign patent cases. Because of the uncertainty concerning patent protection and the unavailability of patent protection for certain processes and techniques, we also rely upon trade secret protection and continuing technological innovation to maintain our competitive position. Although all our employees have signed confidentiality agreements, there can be no assurance that our proprietary technology will not be independently developed by other parties, or that secrecy will not be breached. Additionally, we are aware that substantial research efforts in protein engineering technology are taking place at universities, government laboratories and other corporations and that numerous patent applications have been filed. We cannot predict whether we may have to obtain licenses to use any technology developed by third parties or whether such licenses can be obtained on commercially reasonable terms, if at all. In the course of our business, we employ various trademarks and trade names in packaging and advertising its products. We have assigned the federal registration of our ProNectin/(R)/ trademark and its SmartPlastic/(R)/ trademark for ProNectin F Activated Cultureware to Sanyo Chemical Industries, Ltd. in connection with the sale to Sanyo of our cell culture business. We intend to protect and promote all of our trademarks and, where appropriate, will seek federal registration of our trademarks. Regulatory Matters Regulation by governmental authorities in the United States and other countries is a significant factor affecting the success of products resulting from biotechnological research. Our current operations and products are, and anticipated products and operations will be, subject to 14 substantial regulation by a variety of agencies, particularly those products and operations related to biomedical applications. Currently, our activities are subject principally to regulation under the Occupational Safety and Health Act and the Food, Drug and Cosmetic Act (including amendments and updates). Extensive preclinical and clinical testing and pre-market approval from the FDA is required for new medical devices, drugs or vaccines, which is generally a costly and time-consuming process. We are required to be in compliance with many of the FDA's regulations to conduct testing in support of product approvals; in particular, compliance with the FDA's GLP and QSR. Where we have conducted such testing, our company may choose to file product approval submissions itself or maintain with the FDA a "Master File" containing, among other items, such test results. A Master File can then be accessed by the FDA in reviewing particular product approval submissions from companies commercializing products based on our materials. There can be no assurance that we or our customers will be able to obtain or maintain the necessary approvals from the FDA or corresponding international regulatory authorities, or that we will be able to maintain a Master File in accordance with FDA regulations. In either case, our anticipated business could be adversely affected. To the extent we manufacture medical devices, as opposed to a component material supplied to a medical device manufacturer, we will be required to conform commercial manufacturing operations to the FDA's QSR requirements. We would also be required to register our facility with the FDA as an establishment involved in the manufacture of medical devices. QSR requirements are rigorous, and there can be no assurance that compliance could be obtained in a timely manner and without the expenditure of substantial resources, if at all. International quality system requirements, i.e., ISO 9001 issued by the International Organization for Standardization, is the quality model used by medical product manufacturers and is required for the sale of medical devices in Europe. ISO 9001 standards are similar to the FDA's QSR. In August 1999, we obtained the FDA's approval of our IDE to begin human clinical testing of our urethral bulking agent for the treatment of female stress urinary incontinence. We initiated clinical testing in December 1999. We submitted an IDE to the FDA in October 2000 to obtain approval to begin human clinical testing of a tissue augmentation product for use in cosmetic and reconstructive surgery applications. This IDE was approved in November 2000, and we expect to begin a pilot clinical study in the first quarter of 2001 to the extent resources are available. We have implemented, and continue to implement, polymer production and quality control procedures, and have made certain facilities renovations, to operate in conformance with FDA requirements. Our research, development and production activities are, or may be, subject to various federal and state laws and regulations relating to environmental quality and the use, discharge, storage, transportation and disposal of toxic and hazardous substances. The Company's future activities may be subject to regulation under the Toxic Substances Control Act, which requires us to obtain pre-manufacturing approval for any new "chemical material" we produce for commercial use that does not fall within the FDA's regulatory jurisdiction. We believe we are currently in substantial compliance with all such laws and regulations. Although we intend to use our best efforts to comply with all environmental laws and regulations in the future, there can be 15 no assurance that we will be able to fully comply with such laws, or that full compliance will not require substantial capital expenditures. Product Liability and Absence of Insurance Our business may expose us to potential product liability risks whenever human clinical testing is performed, or upon the use of any commercially marketed medical product. Prior to initiating human clinical testing of our urethral bulking agent, we procured product liability insurance. This insurance coverage has been expanded to cover the cosmetic augmentation product as well. There can be no assurance, however, that we will be able to continue to obtain such insurance on acceptable terms or that such insurance will provide adequate coverage against potential liabilities. A successful product liability claim or series of claims could result in a material adverse effect on our businesss. 16 Executive Officers of the Registrant
Name Age Position with the Company ---- --- ------------------------- J. Thomas Parmeter 61 Chairman of the Board of Directors, President and Chief Executive Officer Joseph Cappello, Ph.D. 44 Vice President, Research and Development, Chief Technical Officer and Director, Polymer Research Philip J. Davis 71 Corporate Secretary Franco A. Ferrari, Ph.D. 49 Vice President, Laboratory Operations and Polymer Production and Director, Molecular Genetics John E. Flowers 44 Vice President, Planning and Operations Janis Y. Neves 50 Director, Finance and Administration, Treasurer, and Assistant Secretary
Mr. Parmeter has been the Company's President, Chief Executive Officer and Chairman of the Board of Directors since its inception in July 1988 (and, from July 1988 to July 1992, its Chief Financial Officer). From 1982 to November 1987, Mr. Parmeter was President, Chief Executive Officer and, from June 1987 to June 1988, Chairman of the Board of Syntro Corporation. Dr. Cappello has been the Company's Vice President, Research and Development since February 1997 and Director, Polymer Research and Chief Technical Officer since February 1993. From September 1988 to February 1993, he was the Company's Senior Research Director, Protein Engineering. Mr. Davis has been the Company's Secretary since January 1989. Mr. Davis has been a director of the Company since April 1995; he previously served as a director of the Company from January 1989 until October 1991. Mr. Davis was employed by Donaldson, Lufkin & Jenrette since June 1994 and retired at the end of 2000 as a Managing Director of Investment Banking. He was Director, Institutional Sales at Merrill Lynch, Inc. (formerly Merrill Lynch Capital Markets) from February 1991 to June 1994, and was a Vice President at Merrill Lynch, Inc. from 1986 to 1991. Dr. Ferrari has been the Company's Vice President, Laboratory Operations and Director, Molecular Genetics since February 1993. From September 1988 to February 1993, he was the Company's Senior Research Director, Genetic Engineering. 17 Mr. Flowers has been the Company's Vice President, Planning and Operations, since February 1993. From September 1988 to February 1993, he was the Company's Vice President, Commercial Development. Ms. Neves has been the Company's Director of Finance since November 1998 and Controller and Assistant Secretary since January 1990. From July 1988 until January 1990, Ms. Neves was the Company's Business Office Manager. All executive officers of our Company were elected by the Board of Directors and serve at its discretion. No family relationships exist between any of the officers or directors of our company. Employees As of February 16, 2001, we had 19 full-time employees, of whom four hold employment contracts with our company and three hold Ph.D. degrees. We are highly dependent on the services of our executive officers and scientists. The loss of the services of any one of these individuals would have a material adverse effect on the achievement of our development objectives, our business opportunities and prospects. The recruitment and retention of additional qualified management and scientific personnel is also critical to our success. There can be no assurance that we will be able to attract and retain required personnel on acceptable terms, due to the competition for such experienced personnel from other biotechnology, pharmaceutical, medical device and chemical companies, universities and non-profit research institutions. Item 2. Properties We do not own any real property. We lease approximately 27,000 square feet in San Diego, California from Sycamore/San Diego Investors. The leased property includes our administrative offices, which encompass approximately 4,000 square feet, and our laboratory facilities, which encompass approximately 15,000 square feet. The current annual rent for this space is approximately $367,000. We currently sublease at cost an additional 9,000 square feet of office and laboratory space in our present facility. The master lease expires in May 2005. The sublease expires at the end of January 2002. We believe that our current facilities are adequate to meet our needs until the end of 2001. Item 3. Legal Proceedings None. Item 4. Submission of Matters to a Vote of Security Holders No matter was submitted to a vote of security holders during the fourth quarter of 2000. 18 PART II Item 5. Market for Common Equity and Related Stockholder Matters. NASDAQ Delisting Prior to September 1999, our common stock traded on The Nasdaq Stock Market under the symbol "PPTI". Our common stock was delisted from the NASDAQ Small Cap Quotation System, effective September 20, 1999. The reasons for the delisting were failure to maintain the minimum bid requirement of $1.00 per share for our common stock, and failure to meet the minimum net asset requirement of $2 million. Our common stock is now traded on the "over-the-counter" NASD Bulletin Board. To access the quotations for our common stock, use the call letters PPTI.OB. The trade prices set forth below represent inter-dealer prices without retail markups, markdowns or commissions, and may not represent actual transactions.
Trade Prices ------------ 2000 High Low ---- ---- --- First Quarter $3.375 $0.187 Second Quarter 1.625 0.750 Third Quarter 1.125 0.562 Fourth Quarter 1.437 0.375 1999 ---- First Quarter $1.531 $1.063 Second Quarter 2.250 0.875 Third Quarter 1.719 0.750 Fourth Quarter 1.250 0.688
As of February 16, 2001, we had approximately 161 shareholders of record; we estimate we had approximately 1,500 beneficial holders. We have never paid cash dividends on our Common Stock. We currently intend to retain earnings, if any, for use in the operation and expansion of our business and therefore do not anticipate paying any cash dividends on our Common Stock in the foreseeable future. Unregistered Offerings On December 21, 2000, Genencor International was issued two warrants, each convertible into the Company's common stock. The warrants were issued in conjunction with our execution of a licensing agreement with Genencor in which Genencor would use our technology for the potential development of products for industrial markets in defined fields. The issuance was exempt under Section 4(2) of the Securities Act. 19 On August 16, 1999, we received $1,775,000 for 17,750 shares of Series G Convertible Preferred Stock ("Series G Stock") from several institutional and accredited individual investors following the 10 day stockholder notification period required by the NASD prior to the sale. On September 15, 1999, we received an additional $325,000 for 3,250 shares of Series G Stock, for a total of $2,100,000. Each share of Series G Stock was priced at $100 per share. Each share can be converted at any time by the holder into common stock at a price of $0.50 per share, subject to certain antidilution adjustments. Each share of Series G Preferred Stock also received a common stock warrant, exercisable for 12 months, that allows the holder to acquire 200 shares of our common stock at a price of $0.50 per share. In February 2000, we received approximately $2.1 million from the exercise of common stock warrants originally granted as part of the sale of Series G Convertible Preferred Stock and warrants. At the time of exercise, exercising shareholders were granted additional warrants for an equivalent number shares, exercisable until the last day of February 2001, bearing a conversion price of $1.50. Between April 1 and April 15, 1999, we received approximately $508,000 from the exercise of redeemable, publicly traded, warrants originally issued as part of our Initial Public Offering. Following the close of business on April 15, the remaining unexercised redeemable, publicly traded, warrants expired. On May 12, 1999, we received approximately $416,000 from the exercise of warrants issued in conjunction with the private placement of the Series E Convertible Preferred Stock ("Series E Stock"). In April and May of 1998, the Company raised approximately $5.4 million from the sale of 54,437 shares of the our Series E Stock priced at $100 per share, with warrants to purchase an aggregate of 3,266,250 shares of common stock to a small group of institutional and accredited investors. Each share of Series E Stock is convertible at any time at the election of the holder into 80 shares of common stock at a conversion price of $1.25 per share, subject to certain antidilution adjustments. No underwriters were engaged in connection with such issuance and, accordingly, no underwriting discounts were paid. Each share of Series E Stock received two common stock warrants. One warrant (first warrant) was exercisable at any time for 40 shares of common stock at an exercise price of $2.50 per share, and has expired approximately 18 months after the close of the offering; the other warrant (second warrant) is exercisable at any time for 20 shares of common stock at an exercise price of $5.00 per share, and expires approximately 36 months after the close of the offering. In addition, an 18 month warrant to acquire 200,000 common shares exercisable at $2.50 per share and a 36 month warrant to acquire 100,000 common shares exercisable at $5.00 per share were issued as a finder and document review fee paid to a lead investor. An 18 month warrant to acquire 32,000 common shares exercisable at $2.50 per share, a 24 month warrant to acquire 16,000 common shares exercisable at $5.00 per share, and 5 year warrants to acquire an aggregate of 25,200 common shares exercisable at $2.50 per share were issued to certain persons for service as finders in relation to the private placement. 20 In connection with the above private placement, we issued 26,420 shares of Series F Convertible Preferred Stock in exchange for the same number of shares of outstanding Series D Convertible Preferred Stock. Series F Convertible Preferred Stock is equivalent to our Series E Stock with regard to liquidation preferences. All other terms of the Company's Series F Convertible Preferred Stock remained the same as our Series D Convertible Preferred Stock. The Series D and F Convertible Preferred Stock is convertible into common stock at the holder's option. The conversion price at the time of conversion is the lesser of $3.75 or the market price. The Series D and F Convertible Preferred Stock is redeemable at our option after four years from the date of issuance. Automatic conversion of all of the Series D and F Convertible Preferred Stock will occur if: (a) we complete a public offering of common stock at a price of $2.50 or higher; or (b) the holders of a majority thereof elect to convert. We have the option to demand conversion of the Series D and F Convertible Preferred Stock if the average market price of its common stock equals or exceeds $5.00 per share over a period of twenty business days. The above issuances of preferred stock and related warrants, and the exercise of such warrants noted above were exempt from registration under Section 4(2) of the Securities Act, and met the requirements of Rule 506 of Regulation D promulgated under the Securities Act. 21 Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operations Forward Looking Statements Certain statements contained or incorporated by reference in this Annual Report on Form 10-KSB constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by forward-looking statements. Such risks and uncertainties include, among others, history of operating losses, raising adequate capital for continuing operations, early stage of product development, scientific and technical uncertainties, competitive products and approaches, reliance upon collaborative partnership agreements and funding, regulatory testing and approvals, patent protection uncertainties and manufacturing scale-up and required qualifications. While these statements represent management's current judgment and expectations for the company, such risks and uncertainties could cause actual results to differ materially from any future results suggested herein. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. General Overview Incorporated in 1988, Protein Polymer Technologies, Inc. has concentrated its research and development efforts on establishing a scientific and technical leadership position in the production and development of unique protein-based materials. We have identified biomedical market and product opportunities for further research and development that we believe will exploit the unique properties of our technology to competitive advantage. We have been unprofitable to date, and as of December 31, 2000 we had an accumulated deficit of $39,743,572. Our product candidates for surgical repair, augmentation and regeneration of human tissues are in various stages of research and development. Our more advanced programs are in the areas of bulking agents for soft tissue augmentation, particularly for use in urethral tissue for the treatment of female stress incontinence and in dermal tissue for cosmetic and reconstructive procedures. We currently are devoting the majority of our resources to the development and registration of these products, with the greatest emphasis on the incontinence product which began human clinical trials in December 1999. Our other advanced product technology is in the area of tissue adhesives and sealants. Currently our research and development in this area is focused on the repair of spinal discs for the treatment of lower back pain. Our first commercial products, ProNectin F and SmartPlastic, are used by biologists and cell culture laboratories, principally to grow mammalian cells for biomedical research purposes. In February 2000, we licensed the rights for the manufacture and sale of these products for use in in vitro cell culture, including the transfer of all existing inventory, to a third party. 22 Our strategy with most of our programs is to enter into collaborative development agreements with major medical product marketing and distribution companies. Although these relationships, to the extent any are consummated, may provide significant near-term revenues through up-front licensing fees, research and development reimbursements and milestone payments, we expect to continue incurring operating losses for the next several years. In December 2000, we entered into a license and collaborative agreement with Genencor International for the development by Genencor of industrial products from our existing biomaterials and for the development of new industrial applications using our proprietary protein polymer technology. The agreement provided for an upfront $750,000 license fee, and also included potential payments of up to $5 million to PPTI for the accomplishment by Genencor of certain milestones, issuance of PPTI common stock warrants to Genencor, PTI, and the payment of royalties to PPTI upon the successful commercialization and sale of products developed under the agreement, if any. Our cash balance as of December 31, 2000 was $866,000. We believe this amount is sufficient to fund our operations through March 2001. In addition to potential cost reduction measures being implemented and/or contemplated, we will continue to attempt to raise additional funds for continuing operations through private or public offerings and collaborative agreements (see "Liquidity and Capital Resources" below, and Note 1 of the Audited Financial Statements for additional information and a description of the associated risks). Results of Operations We received $1,107,000 in contract and licensing revenue for the year ended December 31, 2000 as compared to $2,000 for the years ended December 31, 1999, and $50,000 for the year ended December 31, 1998. The increase in contract and licensing revenue primarily represents the amortized portion of an up front license payment of $1 million (being recognized ratably over a period of three years) from Femcare Ltd. for the commercial rights to our incontinence product in Europe and Australia, payments from Sanyo Chemical Industries Ltd. for the comprehensive license to our in vitro cell culture business and existing product inventory, initial R&D payments from Perkin-Elmer for a development project, and an upfront license fee of $750,000 (less the issuance of warrants to purchase PPTI common stock valued at $319,000) received from Genencor International for rights to use our technology in the development of certain industrial products. The lack of revenue in 1999 and 1998 reflects primarily the termination of research and development reimbursements from various operating entities of the Johnson & Johnson Company, including Ethicon, Inc. Interest income was $79,000 for the year ended December 31, 2000, as compared to $39,000 for 1999 and $135,000 for 1998. The year-to-year variability resulted from the amount and timing of the receipt of equity capital and the amounts of excess cash available for investment. There were no product sales for the year ended December 31, 2000 as compared to $54,000 and $71,000 in 1999 and 1998 respectively. Product sales consisted of ProNectin F related product revenues and licensing fees. Sales prior to 1998 reflected disappointing market interest in the line of ProNectin products; as a result the Company discontinued related 23 promotional expenditures to conserve cash. Sales in 1998 and 1999 primarily reflect distributor stocking orders. The manufacturing and marketing rights and the inventory for this product line were sold to Sanyo Chemical Industries, Ltd. in February 2000. Because of previously booked inventory reserves, there was no cost of sales booked for any product sales in 2000. Research and development expenses for the year ended December 31, 2000 were $2,322,000, compared to $2,812,000 in 1999, a decrease of 17%, and $4,138,000 in 1998. This decrease is due primarily to a downsizing of our staff and operational expenses in 2000, but also in part to lower than expected clinical testing and regulatory consulting costs. These latter savings are temporary and will be replaced and increased by the cost of conducting human clinical testing which began in 1999 for the urinary incontinence bulking agent, and which are expected to begin in 2001 for the dermal augmentation product. Other related expenses include expanded manufacturing capacity and manufacturing process validation, quality assurance efforts, and outside testing services. We expect our research and development expenses will increase in the future, to the extent additional capital is obtained, due to the expansion of product-directed development efforts including human clinical testing, increased manufacturing requirements, and increased use of outside testing services. Selling, general and administrative expenses for the year ended December 31, 2000 were $1,366,000, as compared to $1,554,000 for 1999, a decrease of 12%, and $1,727,000 in 1998. This decrease was due to the Corporate downsizing, and generally tighter cost management. To the extent possible, we continue to concentrate on controlling costs reflected in reduced travel, office supplies, and non-regulatory consulting costs. We expect our selling, general and administrative expenses will increase in the future, to the extent additional capital is obtained, consistent with supporting our research and development efforts and as business development, patent, legal and investor relations activities require. For the year ended December 31, 2000, we recorded a net loss applicable to common shareholders of $2,776,000, or $.16 per share, as compared to $4,535,000, or $.36 per share for 1999, and $9,183,000, or $.88 per share for 1998. The difference between 2000 and 1999 is primarily due to tighter cost management and license and contract fees received from collaborative partners. The difference between 1999 and 1998 results is due primarily to a non-cash "imputed dividend" expense of $3,266,000 that resulted from the sale and issuance of the Company's Series E Convertible Preferred Stock during 1998. The 2000, 1999 and 1998 losses and per share calculations also include $278,000 in each year, of undeclared and/or paid dividends from the Company's Preferred Stock. We expect to incur increasing operating losses for the next several years, to the extent additional capital is obtained, based upon the successful continuation of the tissue augmentation program and product registration, and the tissue adhesives program, as well as expected increases in our other research and development, manufacturing and business development activities. Our results depend in part on our ability to establish strategic alliances and generate contract revenues, increased research, development and manufacturing efforts, preclinical and clinical product testing and commercialization expenditures, expenses incurred for regulatory compliance and patent prosecution, and other factors. Our results will also fluctuate from period to period due to timing differences. 24 To date, we believe that inflation and changing prices have not had a material impact on our continuing operations. However, given the State of California's continuing energy crisis, our utility costs have doubled over the past two months, and these increases are expected to continue for the foreseeable future. Based upon our earnings history, a valuation allowance of $13,943,000 is required to reduce our net deferred tax assets to the amount realizable. Liquidity and Capital Resources As of December 31, 2000, we had cash, cash equivalents and short-term investments totaling $866,000, as compared to $156,000 at December 31, 1999. As of December 31, 2000, we had working capital of $143,000, compared to $(458,000) at December 31, 1999. We received in January and February 2000 approximately $1,350,000 (net of costs) in cash and receivables from licensing and R&D agreements with Femcare, Ltd. for the European and Australian marketing rights to the stress urinary incontinence bulking product, with Perkin-Elmer for a research and development project and commercialization option, and with Sanyo Chemical Industries, Ltd. for the rights to the in vitro cell culture business. Also in February 2000, we received approximately $2.1 million from the exercise of common stock warrants originally granted as part of the sale of Series G Convertible Preferred Stock and warrants. In December 2000, we received $750,000 in the form of an upfront license fee from Genencor International for rights to the use of our technology in the development by Genencor of certain industrial products. We had no long-term capital lease obligations as of December 31, 2000, compared to an obligation of $25,000 as of December 31, 1999. For the year ended December 31, 2000, our cash expenditures for capital equipment and leasehold improvements totaled $45,000, compared with $26,000 for the same period in the prior year. To the extent capital is available, we anticipate that these expenditures will be increased in 2001 for laboratory renovations and additional equipment required to meet GLP manufacturing regulations and production capacity as we scale up our manufacturing operations to meet product requirements for clinical testing. We anticipate a significant increase in manufacturing-related equipment and leasehold improvement expenditures in 2002 due to an increase in need for products for clinical testing and anticipated need for additional product manufacturing for European product sales. We may enter into additional capital equipment lease arrangements in the future if available at appropriate rates and terms. We believe our existing available cash, cash equivalents and short-term investments as of December 31, 2000 will be sufficient to meet our anticipated capital requirements through March 2001. Substantial additional capital resources will be required to fund continuing expenditures related to our research, development, manufacturing and business development activities. We believe there may be a number of alternatives available to meet the continuing capital requirements of our operations, such as collaborative agreements and public or private financings. During 2001, we expect that the possible exercise of other existing warrants could result in additional funds for continuing operations. Further, we are currently in preliminary discussions with a number of potential collaborative partners and, based on the results of various materials evaluations, revenues in the form of license fees, milestone payments or research and development reimbursements could be generated. There can be no assurance that any of these fundings will be consummated in the necessary timeframes needed for continuing operations or on terms favorable to us. If adequate funds are not available, we will be required to significantly 25 curtail our operating plans and may have to sell or license out significant portions of our technology or potential products. Accordingly, in an attempt to extend the time available to pursue alternatives, we now are evaluating other actions, including significantly curtailing our operations, and terminating the employment of a majority of our employees until such time as we are able to stabilize our financial situation. These actions, if undertaken, could extend our operations until May, 2001, but are likely to harm our business and could lead to a near term cessation of our operations, if we are unable to attract additional capital. However, we believe that these curtailed operations and the commensurate reduced burn rate may be sufficient to allow us to advance FDA approved human safety studies for our dermal filler device for use in cosmetic and reconstructive surgery, and/or for our urethral bulking agent for the treatment of female stress urinary incontinence. If successful, we will have achieved a major milestone in demonstrating the safety and initial effectiveness of our lead products, and of equal importance, demonstrating the safety of the underlying biomaterial, Polymer 47K, in humans, which has a large number of other potential high-value biomedical applications. 26 Item 7. Financial Statements Filed herewith are the following Audited Financial Statements for Protein Polymer Technologies, Inc. (a Development Stage Company):
Description Page ----------- ---- Report of Ernst & Young LLP, Independent Auditors.......................... F-2 Balance Sheets at December 31, 2000 and 1999............................... F-3 Statements of Operations for the years ended December 31, 2000, 1999 and 1998 and the period July 6, 1988 (inception) to December 31, 2000... F-4 Statements of Stockholders Equity for the period July 6, 1988 (inception) to December 31, 2000.................................................... F-5 Statements of Cash Flows for the years ended December 31, 2000, 1999 and 1998 and the period July 6, 1988 (inception) to December 31, 2000... F-7 Notes to Financial Statements.............................................. F-9
F-1 Report of Ernst & Young LLP, Independent Auditors The Board of Directors and Stockholders Protein Polymer Technologies, Inc. We have audited the accompanying balance sheets of Protein Polymer Technologies, Inc. (a Development Stage Company) as of December 31, 2000 and 1999, and the related statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 2000 and for the period July 6, 1988 (inception) to December 31, 2000. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Protein Polymer Technologies, Inc. (a Development Stage Company) at December 31, 2000 and 1999, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2000 and for the period July 6, 1988 (inception) to December 31, 2000 in conformity with accounting principles generally accepted in the United States. As discussed in Note 1 to the financial statements, Protein Polymer Technologies, Inc. (a Development State Company) has reported accumulated losses during the development stage aggregating $(39,743,572) and without additional financing, lacks sufficient working capital to fund operations beyond March 2001, which raises substantial doubt about its ability to continue as a going concern. Management's plans as to these matters are described in Note 1. The 2000 financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. ERNST & YOUNG LLP San Diego, California February 8, 2001 F-2 Protein Polymer Technologies, Inc. (A Development Stage Company) Balance Sheets
December 31, 2000 1999 ---------------------------------- Assets Current assets: Cash and cash equivalents $ 866,220 $ 155,692 Other current assets 55,180 49,266 ---------------------------------- Total current assets 921,400 204,958 Deposits 71,177 36,177 Notes receivable from officers 140,000 140,000 Equipment and leasehold improvements, net 250,257 360,005 ---------------------------------- $ 1,382,834 $ 741,140 ================================== Liabilities and stockholders' equity Current liabilities: Accounts payable $ 206,981 $ 385,932 Accrued employee benefits 69,657 84,335 Other accrued expenses 47,418 17,118 Current portion capital lease obligations 25,088 79,593 Deferred revenue 333,333 - Deferred rent 96,191 95,973 ---------------------------------- Total current liabilities 778,668 662,951 Long-term portion deferred revenue 333,334 - Long-term portion capital lease obligations - 25,088 Stockholders' equity: Convertible Preferred Stock, $.01 par value, 5,000,000 shares authorized, 80,076 and 91,064 shares issued and outstanding at December 31, 2000 and 1999, respectively - liquidation preference of $8,007,600 and $9,106,400 at December 31, 2000 and December 31, 1999, respectively 7,662,272 8,761,072 Common stock, $.01 par value, 40,000,000 shares authorized, 18,910,313 and 13,443,510 shares issued and outstanding at December 31, 2000 and 1999, respectively 189,115 134,447 Additional paid-in capital 32,163,017 28,403,077 Deficit accumulated during development stage (39,743,572) (37,245,495) ---------------------------------- Total stockholders' equity 270,832 53,101 ---------------------------------- $ 1,382,834 $ 741,140 ==================================
See accompanying notes. F-3 Protein Polymer Technologies, Inc. (A Development Stage Company) Statement of Operations
For the period July 6, 1988 (inception) to Years ended December 31, December 31, 2000 1999 1998 2000 ---------------------------------------------------------- Revenues: Contract revenue $ 1,107,396 $ 2,320 $ 50,000 $ 5,464,681 Interest income, net 79,087 39,343 134,978 1,199,359 Product and other income 3,012 54,304 70,846 687,329 ---------------------------------------------------------- Total revenues 1,189,495 95,967 255,824 7,351,369 Expenses: Research and development 2,321,974 2,799,147 4,167,144 27,076,055 Selling, general and administrative 1,365,598 1,554,351 1,726,883 16,070,501 ---------------------------------------------------------- Total expenses 3,687,572 4,353,498 5,894,027 43,146,556 ---------------------------------------------------------- Net loss (2,498,077) (4,257,531) (5,638,203) (35,795,187) Undeclared and/or paid dividends on preferred stock 277,639 277,639 3,544,323 5,517,293 ---------------------------------------------------------- Net loss applicable to common shareholders $(2,775,716) $(4,535,170) $(9,182,526) $(41,312,480) ========================================================== Net loss per common share - basic and diluted $ (.16) $ (.36) $ (.88) ========================================= Shares used in computing net loss per common share - basic and diluted 17,771,744 12,570,987 10,484,277 =========================================
See accompanying notes. F-4 Protein Polymer Technologies, Inc. (A Development Stage Company) Statements of Stockholders' Equity For the period July 6, 1988 (inception) to December 31, 2000
Common stock Preferred stock ---------------------------------------------------- Shares Amount Shares Amount ----------------------------------------------------- Issuance of common stock at $.01 per share for cash 400,000 $ 4,000 - $ - Issuance of common stock at $.62 per share for cash and receivables 1,116,245 11,162 - - Receivables from sale of common stock - - - - Net loss - - - - ----------------------------------------------------- Balance at December 31, 1988 1,516,245 15,162 - - Repayment of receivables from sale of common stock - - - - Issuance of common stock at $.62 per share 359,136 3,594 - - Net loss - - - - ----------------------------------------------------- Balance at December 31, 1989 1,875,381 18,756 - - Exercise of common stock options at $.01 per share for cash 60,000 600 - - Issuance of common stock at $.68 per share for cash and compensation 5,000 50 - - Common stock repurchased at $.01 per share for cash (25,000) (250) - - Common stock issued at $.68 per share for cash and compensation 25,000 250 - - Net loss - - - - ----------------------------------------------------- Balance at December 31, 1990 1,940,381 19,406 - - Exercise of common stock options at $.68 per share for cash 5,000 50 - - Exercise of warrants for common stock 483,755 4,837 - - Conversion of notes payable to common stock 339,230 3,391 - - Conversion of notes payable to preferred stock - - 278,326 2,783 Issuance of preferred stock at $2.00 per share for cash, net of issuance costs - - 400,000 4,000 Issuance of warrants for cash - - - - Issuance of warrants in connection with convertible notes payable - - - - Net loss - - - - ----------------------------------------------------- Balance at December 31, 1991 2,768,366 27,684 678,326 6,783 Initial public offering at $6.50 per unit, net of issuance costs 1,667,500 16,676 - - Conversion of Series B preferred stock into common stock in connection with initial public offering 678,326 6,783 (678,326) (6,783) Conversion of Series A preferred stock into common stock at 1.13342 per share 713,733 7,137 - - Net loss - - - - ----------------------------------------------------- Balance at December 31, 1992 5,827,925 58,280 - - Exercise of common stock options at $.68 per share 3,000 30 - - Net loss - - - - ----------------------------------------------------- Balance at December 31, 1993 5,830,925 58,310 - - Issuance of preferred stock at $100 per share for cash, net of issuance costs - - 21,600 2,073,925 Net loss - - - - ----------------------------------------------------- Balance at December 31, 1994 5,830,925 58,310 21,600 2,073,925 Issuance of preferred stock at $100 per share for cash and cancellation of bridge loan, net of issuance costs - - 25,000 2,432,150 Series C dividends paid in Series D preferred stock - - 2,539 253,875 Interest paid in Series D preferred stock - - 48 4,795 Exercise of common stock options at $.53 per share 2,000 20 - - Net loss - - - - ----------------------------------------------------- Balance at December 31, 1995 5,832,925 $58,330 49,187 $4,764,745
Deficit Additional Accumulated Total paid-in During Receivables Stockholders capital development stage from stock equity - ---------------------------------------------------------------------------------------------------------------------------------- Issuance of common stock at $.01 per share for cash $ - $ - $ - $ 4,000 Issuance of common stock at $.62 per share for cash and receivables 681,838 - - 693,000 Receivables from sale of common stock - - (86,000) (86,000) Net loss - (322,702) - (322,702) -------------------------------------------------------------- Balance at December 31, 1988 681,838 (322,702) (86,000) 288,298 Repayment of receivables from sale of common stock - - 86,000 86,000 Issuance of common stock at $.62 per share 219,358 - - 222,952 Net loss - (925,080) - (925,080) -------------------------------------------------------------- Balance at December 31, 1989 901,196 (1,247,782) - (327,830) Exercise of common stock options at $.01 per share for cash - - - 600 Issuance of common stock at $.68 per share for cash and compensation 3,350 - - 3,400 Common stock repurchased at $.01 per share for cash - - - (250) Common stock issued at $.68 per share for cash and compensation 16,750 - - 17,000 Net loss - (1,501,171) - (1,501,171) -------------------------------------------------------------- Balance at December 31, 1990 921,296 (2,748,953) - (1,808,251) Exercise of common stock options at $.68 per share for cash 3,350 - - 3,400 Exercise of warrants for common stock 295,493 - - 300,330 Conversion of notes payable to common stock 508,414 - - 511,805 Conversion of notes payable to preferred stock 553,869 - - 556,652 Issuance of preferred stock at $2.00 per share for cash, net of issuance costs 703,475 - - 707,475 Issuance of warrants for cash 3,000 - - 3,000 Issuance of warrants in connection with convertible notes payable 28,000 - - 28,000 Net loss - (1,143,119) - (1,143,119) -------------------------------------------------------------- Balance at December 31, 1991 3,016,897 (3,892,072) - (840,708) Initial public offering at $6.50 per unit, net of issuance costs 8,911,024 - - 8,927,700 Conversion of Series B preferred stock into common stock in connection with initial public offering - - - - Conversion of Series A preferred stock into common stock at 1.13342 per share 1,717,065 - - - Net loss - (3,481,659) - (3,481,659) -------------------------------------------------------------- Balance at December 31, 1992 13,644,986 (7,373,731) - 6,329,535 Exercise of common stock options at $.68 per share 2,010 - - 2,040 Net loss - (3,245,436) - (3,245,436) -------------------------------------------------------------- Balance at December 31, 1993 13,646,996 (10,619,167) - 3,086,139 Issuance of preferred stock at $100 per share for cash, net of issuance costs - - - 2,073,925 Net loss - (3,245,359) - (3,245,359) -------------------------------------------------------------- Balance at December 31, 1994 13,646,996 (13,864,526) - 1,914,705 Issuance of preferred stock at $100 per share for cash and cancellation of bridge loan, net of issuance costs - - - 2,432,150 Series C dividends paid in Series D preferred stock - (253,875) - - Interest paid in Series D preferred stock - - - 4,795 Exercise of common stock options at $.53 per share 1,040 - - 1,060 Net loss - (2,224,404) - (2,224,404) -------------------------------------------------------------- Balance at December 31, 1995 $13,648,036 $(16,342,805) - $ 2,128,306
F-5 Protein Polymer Technologies, Inc. (A Development Stage Company) Statements of Stockholders' Equity For the period July 6, 1988 (inception) to December 31, 2000
Common stock Preferred stock ------------------------------------------------ Shares Amount Shares Amount ------------------------------------------------ Exercise of common stock warrants at $1.25 per share 932,960 $ 9,330 - $ - Exercise of common stock warrants at $2.50 per share, net of issuance costs 322,663 3,226 - - Exercise of common stock warrants at $1.00 per share 25,000 250 - - Exercise of common stock options 136,000 1,360 - - Stock repurchases (16,320) (163) - - Net loss - - - - ------------------------------------------------ Balance at December 31, 1996 7,233,228 72,333 49,187 4,764,745 Issuance of common stock at $2.50 per share, net of issuance costs 1,904,000 19,040 - - Exercise of common stock options 28,000 280 - - Issuance of common stock under stock purchase plan 15,036 151 - - Conversion of Series D preferred stock into common stock 1,032,537 10,325 (20,973) (2,097,342) Series D dividends paid in common stock 207,921 2,079 - - Net loss - - - - ------------------------------------------------ Balance at December 31, 1997 10,420,722 104,208 28,214 2,667,403 Issuance of common stock under stock purchase plan 36,715 368 - - Exercise of common stock options 12,000 120 - - Issuance of common stock at $1.60 per share, net of issuance costs 23,439 234 - - Issuance of Series E preferred stock, net of issuance costs - - 54,438 5,277,813 Grant of stock to finder 64,000 640 - - Conversion of Series D and E preferred stock into common stock 270,364 2,704 (3,450) (344,990) Net Loss - - - - ------------------------------------------------ Balance at December 31, 1998 10,827,240 108,274 79,202 7,600,226 Issuance of common stock under stock purchase plan 19,429 194 - - Issuance of common stock and warrants for services rendered and debt issued 16,941 180 - - Issuance of Series G preferred stock, net of issuance costs - - 21,000 2,074,596 Conversion of Series E preferred stock into common stock 731,000 7,310 (9,138) (913,750) Exercise of common stock and Series E warrants at $.50 per share 1,848,900 18,489 - - Net Loss and comprehensive loss - - - - ------------------------------------------------ Balance at December 31, 1999 13,443,510 134,447 91,064 8,761,072 Issuance of common stock under stock purchase plan 287,303 2,873 - - Issuance of warrants and stock options for services rendered - - - - Exercise of common stock options 85,500 855 - - Exercise of common stock warrants at $.50 per share 4,215,000 42,150 - - Conversion of Series E preferred stock into common stock 879,000 8,790 (10,988) (1,098,800) Net Loss and comprehensive loss - - - - ------------------------------------------------ Balance at December 31, 2000 18,910,313 $189,115 80,076 $ 7,662,272 ================================================
Deficit Additional Accumulated Total paid-in During Receivables Stockholders capital development stage from stock equity - ------------------------------------------------------------------------------------------------------------------------------------ Exercise of common stock warrants at $1.25 per share $ 1,156,870 $ - $ - $ 1,166,200 Exercise of common stock warrants at $2.50 per share, net of issuance costs 779,413 - - 782,639 Exercise of common stock warrants at $1.00 per share 24,750 - - 25,000 Exercise of common stock options 91,650 - - 93,010 Stock repurchases (81,437) - - (81,600) Net loss - (2,864,432) - (2,864,432) ---------------------------------------------------------------- Balance at December 31, 1996 15,619,282 (19,207,237) - 1,249,123 Issuance of common stock at $2.50 per share, net of issuance costs 4,601,322 - - 4,620,362 Exercise of common stock options 20,200 - - 20,480 Issuance of common stock under stock purchase plan 29,950 - - 30,101 Conversion of Series D preferred stock into common stock 2,087,017 - - - Series D dividends paid in common stock 420,262 (422,341) - - Net loss - (4,453,933) - (4,453,933) ---------------------------------------------------------------- Balance at December 31, 1997 22,778,033 (24,083,511) - 1,466,133 Issuance of common stock under stock purchase plan 38,010 - - 38,378 Exercise of common stock options 7,920 - - 8,040 Issuance of common stock at $1.60 per share, net of issuance costs 37,266 - - 37,500 Issuance of Series E preferred stock, net of issuance costs 3,266,250 (3,266,250) - 5,277,813 Grant of stock to finder 79,360 - - 80,000 Conversion of Series D and E preferred stock into common stock 342,286 - - - Net Loss - (5,638,203) - (5,638,203) ---------------------------------------------------------------- Balance at December 31, 1998 26,549,125 (32,987,964) - 1,269,661 Issuance of common stock under stock purchase plan 15,111 - - 15,305 Issuance of common stock and warrants for services rendered and debt issued 26,440 - - 26,620 Issuance of Series G preferred stock, net of issuance costs - - - 2,074,596 Conversion of Series E preferred stock into common stock 906,440 - - - Exercise of common stock and Series E warrants at $.50 per share 905,961 - - 924,450 Net Loss and comprehensive loss - (4,257,531) - (4,257,531) ---------------------------------------------------------------- Balance at December 31, 1999 28,403,077 (37,245,495) - 53,101 Issuance of common stock under stock purchase plan 186,096 - - 188,969 Issuance of warrants and stock options for services rendered 345,244 - - 345,244 Exercise of common stock options 73,240 - - 74,095 Exercise of common stock warrants at $.50 per share 2,065,350 - - 2,107,500 Conversion of Series E preferred stock into common stock 1,090,010 - - - Net Loss and comprehensive loss - (2,498,077) - (2,498,077) ---------------------------------------------------------------- Balance at December 31, 2000 $32,163,017 $(39,743,572) $ - $ 270,832 ================================================================
See accompanying notes. F-6 Protein Polymer Technologies, Inc. (A Development Stage Company) Statements of Cash Flows
For the period July 6, 1988 (inception) to Years ended December 31, December 31, 2000 1999 1998 2000 ------------------------------------------------------------- Operating activities Net loss $(2,498,077) $(4,257,531) $(5,638,203) $(35,801,106) Adjustments to reconcile net loss to net cash used for operating activities: Stock and warrants issued for services rendered and debt interest 345,244 26,620 80,000 476,759 Depreciation and amortization 155,060 264,541 368,577 2,047,898 Write-off of purchased technology - - - 503,500 Changes in assets and liabilities: Deposits (35,000) - 440 (71,177) Notes receivable from officers - 1,000 12,000 (140,000) Other current assets (5,914) 17,193 22,409 (55,180) Accounts payable (178,951) (129,481) 91,819 206,981 Accrued employee benefits (14,678) (83,514) 16,018 69,657 Other accrued expenses 30,300 (4,456) (19,577) 47,418 Deferred revenue 666,667 - - 666,667 Deferred rent 218 35,305 60,668 96,191 ---------------------------------------------------------- Net cash used for operating activities (1,867,625) (4,130,323) (5,005,849) (32,284,886) Investing activities Purchase of technology - - - (570,000) Purchase of equipment and improvements (45,313) (26,099) (197,460) (1,856,127) Purchases of short-term investments - - - (16,161,667) Sales of short-term investments - - 974,817 16,161,667 ---------------------------------------------------------- Net cash provided by (used for) investing activities (45,313) (26,099) 777,357 (2,426,127) Financing activities Net proceeds from issuance of common stock 2,370,565 939,755 83,918 19,908,231 Net proceeds from issuance of preferred stock - 2,074,596 5,277,813 14,290,160 Net proceeds from convertible notes and detachable warrants - - - 1,068,457 Payments on capital lease obligations (79,593) (85,385) (75,112) (263,682) Payment on note payable - (150,000) - (242,750) Proceeds from note payable - 150,000 - 484,323 ---------------------------------------------------------- Net cash provided by financing activities 2,623,466 2,928,966 5,286,619 35,577,233 Net increase (decrease) in cash and cash equivalents 710,528 (1,227,456) 1,058,127 866,220 Cash and cash equivalents at beginning of the period 155,692 1,383,148 325,021 - ---------------------------------------------------------- Cash and cash equivalents at end of the period $ 866,220 $ 155,692 $ 1,383,148 $ 866,220 ==========================================================
F-7 Protein Polymer Technologies, Inc. (A Development Stage Company) Statements of Cash Flows
July 6, 1988 (inception) to Years ended December 31, December 31, 2000 1999 1998 2000 -------------------------------------------------- Supplemental disclosures of cash flow information Equipment purchased by capital leases $ - $ - $ - $ 288,772 Interest paid 7,204 19,983 26,692 125,115 Imputed dividend on Series E stock - - 3,266,250 3,266,250 Conversion of Series D preferred stock to common stock - - 44,990 2,142,332 Conversion of Series E preferred stock to - - - - common stock 1,098,800 913,750 300,000 2,312,550 Series D stock issued for Series C stock - - - 2,073,925 Series C dividends paid with Series D stock - - - 253,875 Series D dividends paid with common stock - - - 422,341
See accompanying notes. F-8 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements December 31, 2000 1. Organization and Significant Accounting Policies Organization and business activities Protein Polymer Technologies, Inc. (the "Company") was established to design, produce and market genetically engineered protein polymers for a variety of biomedical and specialty materials applications. The Company was incorporated in Delaware on July 6, 1988. For the period from its inception to date, the Company has been a development stage enterprise, and accordingly, the Company's operations have been directed primarily toward developing business strategies, raising capital, research and development activities, conducting clinical testing of its product candidates, exploring marketing channels and recruiting personnel. Liquidity As of December 31, 2000, the Company had cash, cash equivalents and short-term investments totaling $866,000 as compared to $156,000 at December 31, 1999. As of December 31, 2000, the Company had working capital of $143,000 compared to $(458,000) at December 31, 1999. The Company believes its available cash, cash equivalents and short-term investments would be sufficient to meet its anticipated capital requirements through March 2001. Prior to the commercialization of its products, substantial additional capital resources will be required to fund continuing operations related to the Company's research, development, manufacturing, clinical testing, and business development activities. The Company believes there may be a number of alternatives available to meet the continuing capital requirements of its operations, such as collaborative agreements and public or private financings. During 2001, the Company expects that the possible exercise of existing warrants could result in additional funds for continuing operations. Further, the Company is currently in discussions with a number of potential collaborative partners and, based on the results of various materials evaluations, funding in the form of license fees, milestone payments or research and development reimbursements could be generated. There can be no assurance that any of these fundings will be consummated in the necessary time frames needed for continuing operations or on terms favorable to the Company. If adequate funds in the future are not available, the Company will be required to significantly curtail its operating plans and may have to sell or license out significant portions of the Company's technology or potential products. F-9 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 1. Organization and Significant Accounting Policies (continued) Cash equivalents and short-term investments Short-term investments consist primarily of commercial paper, notes and short- term U.S. Government securities with original maturities beyond three months and are stated at estimated fair value. Similar items with original maturities of three months or less are considered cash equivalents. The Company has established guidelines relative to diversification and maturities that maintain safety and liquidity. The Company has not experienced any losses on its short- term investments. Equipment and leasehold improvements Equipment and leasehold improvements are stated at cost, less accumulated depreciation and amortization. Equipment is depreciated over the estimated useful life of the asset, typically one to seven years, using the straight-line method. Leasehold improvements are amortized over the shorter of the lease term or life of the asset. Equipment and leasehold improvements consist of the following:
December 31, 2000 1999 -------------------------------- Laboratory equipment $ 1,672,135 $ 1,626,822 Office equipment 175,128 175,128 Leasehold improvements 297,635 297,635 -------------------------------- 2,144,898 2,099,585 Less accumulated depreciation and amortization (1,894,641) (1,739,580) -------------------------------- $ 250,257 $ 360,005 ================================
Research and Development Revenues and Expenses Research and development contract revenues are recorded as earned based on the performance requirements of the contracts. If the research and development activities are not successful, the Company is not obligated to refund payments previously received. Milestone and license payments are recorded as revenue when received as they are not refundable and the Company has no future performance obligations. Payments received in advance of amounts earned are recorded as deferred revenue. Research and development costs are expensed as incurred. F-10 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 1. Organization and Significant Accounting Policies (continued) Product revenue recognition Sales are recognized upon shipment of products to customers. Accounting Standard on Impairment of Long-Lived Assets In accordance with Statement of Financial Accounting Standards ("SFAS") No. 121, Accounting for Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of, the Company regularly evaluates its long-lived assets for indicators of possible impairment. To date, no such indicators have been identified. Stock Options As permitted by SFAS No. 123, Accounting for Stock-Based Compensation, the Company has elected to follow Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, ("APB 25") and related Interpretations in accounting for its employee stock options. Under APB 25, if the exercise price of the Company's employee stock options equals or exceeds the deemed fair value of the underlying stock on the date of grant, no compensation expense is recognized. In accordance with EITF 96-18 options issued to non-employees are recorded at their fair value and recognized over the related service period. The effects of using the fair value accounting method, as described in SFAS Statement No. 123 are described below in Note 2. Net loss per common share The Company reports its earnings per share in accordance with SFAS No. 128, Earnings per Share, which requires the presentation of both basic and diluted earnings per share on the statements of operations. Basic earnings per share are calculated based upon weighted-average number of outstanding common shares for the period. Diluted earnings per share are calculated based upon weighted- average number of outstanding common shares, plus the effect of dilutive stock options. The net loss per common share for the years ended December 31, 2000, 1999 and 1998 is based on the weighted average number of shares of common stock outstanding during the periods. Potentially dilutive securities include options, warrants and convertible preferred stock; however, such securities have not been included in the calculation of the net loss per F-11 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 1. Organization and Significant Accounting Policies (continued) common share as their effect is antidilutive. Since this is the case, there is no difference between the basic and dilutive net loss per common share for any of the periods presented and none of the prior periods were required to be restated. For purposes of this calculation, net loss in 2000, 1999 and 1998 has been adjusted for accumulated and/or paid dividends on the Preferred Stock. Comprehensive Income SFAS No. 130, Reporting Comprehensive Income, requires that the Company disclose, either in the income statement or in a separate financial statement, net income as currently reported and other components of comprehensive income. Comprehensive income is defined as the change in shareholders' equity during a period resulting from transactions and other events and circumstances from non- owner sources. The Company adopted this standard during 1998. For the years ended December 31, 2000, 1999 and 1998 the Company did not have any components of comprehensive income as defined in SFAS No. 130. New Accounting Standards In June 1998, the Financial Accounting Standards Board issued SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, which will be effective January 1, 2001. SFAS No. 133 establishes accounting and reporting standards requiring that every derivative instrument, including certain derivative instruments imbedded in other contracts, be recorded in the balance sheet as either an asset or liability measured at its fair value. The statement also requires that changes in the derivative's fair value be recognized in earnings unless specified hedge accounting criteria are met. Management believes the adoption of SFAS No. 133 will not have an effect on the financial statements, as the Company does not engage in the activities covered by SFAS No. 133. In December 1999, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin No. 101, Revenue Recognition (SAB 101). SAB 101 provides the SEC Staff's views in applying generally accepted accounting principles to various revenue recognition issues and specifically addresses revenue recognition for upfront, non-refundable fees earned in connection with research collaboration agreements. It is the SEC's position that such fees should generally be recognized over the term of the agreement. The Company expects to F-12 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 1. Organization and Significant Accounting Policies (continued) apply this accounting to its future collaborations. The Company believes its historical revenue recognition policy is in compliance with SAB 101. In March 2000, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No. 44 ("FIN44"), Accounting for Certain Transactions Involving Stock Compensation. The Company adopted FIN 44 effective July 1, 2000 with respect to certain provisions applicable to new awards, exchanges of awards in a business combination, modifications to outstanding awards, and changes in grantee status that occur on or after that date. FIN 44 addresses practice issues related to the application of Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees. The adoption of FIN 44 had no impact on the Company's financial position or results of operations. Use of estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the amount of revenue and expense reported during the period. Actual results could differ from those estimates. 2. Stockholders' Equity Convertible Preferred Stock On August 16, 1999, the Company received $1,775,000 for 17,750 shares of Series G Preferred Stock from several institutional and accredited individual investors. On September 15, 1999, the Company received an additional $325,000 for 3,250 shares of Series G Preferred Stock, for a total of $2,100,000. Each share of Series G Convertible Preferred Stock was priced at $100 per share. Each share can be converted at any time by the holder into common stock at a price of $0.50 per share, subject to certain antidilution adjustments. Each share of Preferred Stock also receives a common stock warrant, exercisable for 12 months, that allows the holder to acquire 200 shares of PPTI common stock at a price of $0.50 per share. In April 1999, the Company received approximately $508,000 from the exercise of redeemable, publicly traded, warrants originally issued as part of PPTI's Initial Public F-13 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 2. Stockholders' Equity (continued) Offering. Following the close of business on April 15, the remaining unexercised redeemable, publicly traded, warrants expired. On May 12, 1999, the Company received approximately $416,000 from the exercise of warrants issued in conjunction with the private placement of the Company's Series E Convertible Preferred Stock. In 1998, the Company raised approximately $5.4 million from the sale of 54,437 shares of the Company's Series E Convertible Preferred Stock ("Series E Stock") priced at $100 per share, with warrants to purchase an aggregate of 3,266,250 shares of common stock to a small group of institutional and accredited investors. In connection with this transaction, the Company recorded a non-cash "imputed dividend" expense of $3,266,250 in order to account for the difference between the fair market value of the common stock and the conversion price of the preferred stock into common stock. Each share of Series E Stock is convertible at any time at the election of the holder into 80 shares of common stock at a conversion price of $1.25 per share, subject to certain antidilution adjustments. As of December 31, 2000, 19,125 shares of Series E Stock had been converted into 1,530,000 shares of the Company's common stock. Each share of Series E Stock received two common stock warrants. One warrant is exercisable at any time for 40 shares of common stock at an exercise price of $2.50 per share, and expired approximately 18 months after the close of the offering; the other warrant is exercisable at any time for 20 shares of common stock at an exercise price of $5.00 per share, and expires approximately 36 months after the close of the offering. In addition, an 18 month warrant to acquire 200,000 common shares exercisable at $2.50 per share and a 36 month warrant to acquire 100,000 common shares exercisable at $5.00 per share were issued as a finder and document review fee paid to a lead investor. An 18 month warrant to acquire 32,000 common shares exercisable at $2.50 per share, a 24 month warrant to acquire 16,000 common shares exercisable at $5.00 per share, and 5 year warrants to acquire an aggregate of 25,200 common shares exercisable at $2.50 per share were issued to certain persons for service as finders in relation to the private placement. In connection with the above private placement, the Company issued 26,420 shares of its Series F Convertible Preferred Stock ("Series F Stock") in exchange for the same number F-14 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 2. Stockholders' Equity (continued) of shares of outstanding Series D Convertible Preferred Stock ("Series D Stock"). Each share Series D and F Stock earns a cumulative dividend at the annual rate of $10 per share, payable if and when declared by the Company's Board of Directors, in the form of cash, common stock or any combination thereof. The Series D and F Stock is convertible into common stock after two years from the date of issuance at the holder's option. The conversion price at the time of conversion is the lesser of $3.75 or the market price. The Series D and F Stock is redeemable at the Company's option after four years from the date of issuance. Automatic conversion of all of the Series D and F Stock will occur if: (a) the Company completes a public offering of common stock at a price of $2.50 or higher; or (b) the holders of a majority thereof elect to convert. The Company has the option to demand conversion of the Series D and F Stock if the average market price of its common stock equals or exceeds $5.00 per share over a period of twenty business days. The Series D Stock has a liquidation preference of $100 per share plus accumulated dividends. The Series E Stock is convertible, at the option of the holder, into shares of the Company's common stock, subject to anti-dilution adjustments, and has a preference in liquidation of $100 per share, but only after any preference is paid or declared set apart for the Series D Stock. The Company's Series F Stock is equivalent to the Company's Series E Stock with regard to liquidation preferences. All other terms of the Series F Stock remain the same as the Company's Series D Stock. Holders of the Series E Stock are entitled to receive dividends when and if declared by the Board of Directors; however, no such dividends will be declared or paid on the Series E Stock until the preferential cumulative dividends on the Series D and F Stock have been fully paid or declared and set apart. Automatic conversion of all Series E Stock will occur if: (a) the Company completes a public offering of common stock at a price of $7.50 or higher; or (b) the holders of more than 75% of outstanding Series E Stock elect to convert. Series D, E and F Convertible Preferred Stock has been designated as non-voting stock. Stock option plans In September 1996 the Company established the Protein Polymer Technologies, Inc., F-15 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 2. Stockholders' Equity (continued) Employee Stock Purchase Plan ("Plan"). The Plan commenced January 2, 1997, and allows for offering periods of up to two years with quarterly purchase dates occurring the last business day of each quarter. The purchase price per share is generally calculated at 85% of the lower of the fair market value on an eligible employee's entry date or the quarterly purchase date. The maximum number of shares available for issuance under the Plan is 500,000; an eligible employee may purchase up to 5,000 shares per quarter. The Plan Administrator consists of a committee of at least two non-employee directors of the Company. The Board may modify the Plan at any time. During 2000, a total of 287,303 shares were purchased under the Plan at prices ranging from $0.27 to $0.96. The value of shares issued under the Plan as calculated in accordance with Statement 123 is not significant and is not included in the following pro forma information. In June 1996, the Company adopted the 1996 Non-Employee Directors Stock Option Plan ("1996 Plan"), which provides for the granting of nonqualified options to purchase up to 250,000 shares of common stock to directors of the Company. Such grants of options to purchase 5,000 shares of common stock are awarded automatically on the first business day of June during each calendar year to every Participating Director then in office, subject to certain adjustments. No Participating Director is eligible to receive more than one grant per year. The purchase price of each option is set at the fair market value of the common stock on the date of grant. Each option has a duration of ten years, and is exercisable six months after the grant date. The Board (or a designated committee of the Board) administers the 1996 Plan. At December 31, 2000, 165,000 options to purchase have been granted under the 1996 Plan. The Company adopted the 1992 Stock Option Plan, which provides for the issuance of incentive and non-statutory stock options for the purchase of up to 1,500,000 shares of common stock to its key employees and certain other individuals. The options will expire ten years from their respective dates of grant. Options become exercisable ratably over periods of up to five years from the dates of grant. At December 31, 2000, options to purchase 643,000 shares of common stock were exercisable, and 311,500 shares were available for future grant. The Company adopted the 1989 Stock Option Plan, which provided for the issuance of incentive and non-statutory stock options for the purchase of up to 500,000 shares of common stock to key employees and certain other individuals. The 1989 Stock Option Plan F-16 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 2. Stockholders' Equity (continued) expired as of March 17, 1999. Options granted in the plan became exercisable ratably over periods of up to five years from the date of grant. At December 31, 2000, options for 380,000 shares were exercisable. Since inception, the Company has granted non-qualified options outside the option plans to employees, directors and consultants of the Company. At December 31, 2000, options for 115,000 shares were exercisable. The following table summarizes the Company's stock option activity:
Years ended December 31, -------------------------------------------------------------------------------------- 2000 1999 1998 ------------------------- ----------------------- ------------------------ Weighted Weighted Weighted Average Average Average Exercise Exercise Exercise Options Price Options Price Options Price --------- -------- --------- -------- --------- --------- Outstanding - beginning of year 1,998,000 $1.23 1,765,000 $1.51 1,540,600 $1.52 Granted 173,500 $1.07 548,500 $0.44 568,000 $0.99 Exercised (85,500) $0.87 - - (12,000) $0.67 Forfeited/Expired (168,500) $1.52 (315,500) $1.40 (331,600) $0.83 --------- ----- --------- ----- --------- ----- Outstanding - end of year 1,917,500 $1.22 1,998,000 $1.23 1,765,000 $1.51 ========= ===== ========= ===== ========= ===== Exercisable - end of year 1,298,000 $1.34 1,152,000 $1.37 1,093,600 $1.36 ========= ===== ========= ===== ========== =====
The exercise prices for options outstanding as of December 31, 2000 range from $0.88 to $1.31. The weighted average remaining contractual life of these options is approximately 6.56 years. Statement 123 pro forma information Pro forma information regarding net loss is required by SFAS No. 123, and has been determined as if the Company had accounted for its employee stock options under the fair F-17 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 2. Stockholders' Equity (continued) value method prescribed by SFAS No. 123, using the Black-Scholes option pricing model. The fair value was estimated using the following weighted-average assumptions: a risk free interest rate of 5.50% for 2000, 5.50% for 1999 and 6.00% for 1998; a volatility factor of the expected market price of the Company's common stock of 100% for 2000, 100% for 1999 and 89% for 1998; expected option lives of 10 years for 2000, 5 years for 1999, 5 years for 1998; and no dividend yields for all years. The Black-Scholes option valuation model was originally developed for use in estimating the fair value of traded options which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because the Company's employee stock options have characteristics significantly different from those of traded options and because changes in the subjective input assumptions can materially affect the fair value estimate, in management's opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options. For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the expected life of the options. The Company's pro forma information is as follows: 2000 1999 1998 ---- ---- ---- Net loss as reported $(2,775,716) $(4,535,170) $(9,182,526) Net loss per share as reported (0.16) (0.36) (0.88) Net loss pro forma (3,077,468) (4,772,359) (9,877,344) Net loss per share pro forma (0.17) (.38) (.94) Weighted average fair value per share of options granted during the year $ 0.95 $ 0.34 $ 0.87
The pro forma effect on net loss for 2000, 1999 and 1998 is not representative of the pro forma effect on net loss in future years because it does not take into consideration pro forma compensation expense from option grants made prior to 1995. 3. Stockholder Protection Agreement In 1997, the Board of Directors of the Company adopted a Stockholder Protection Agreement ("Rights Plan") that distributes Rights to stockholders of record as of F-18 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 3. Stockholder Protection Agreement (continued) September 10, 1997. The Rights Plan contains provisions to protect stockholders in the event of an unsolicited attempt to acquire the Company. The Rights trade together with the common stock, and generally become exercisable ten business days after a person or group acquires or announces the intention to acquire 15% or more of the outstanding shares of Company common stock, with certain permitted exceptions. The Rights then generally allow the holder to acquire additional shares of Company capital stock at a discounted price. The issuance of the Rights is not a taxable event, does not affect the Company's reported earnings per share, and does not change the manner in which the Company's common stock is traded. 4. Commitments The Company leases its office and research facilities totaling 27,000 square feet under an operating lease, which expires in May 2005. The facilities lease is subject to an annual escalation provision based upon the Consumer Price Index. The lease provides for deferred rent payments; however, for financial purposes rent expense is recorded on a straight-line basis over the term of the lease. Accordingly, deferred rent in the accompanying balance sheet represents the difference between rent expense accrued and amounts paid under the lease agreement. F-19 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements (continued) December 31, 2000 4. Commitments (continued) Annual future minimum operating and capital lease payments are as follows:
Obligations Operating Under Year ending December 31, Leases Capital Leases ------------------------ ---------- -------------- 2001 $ 460,933 $ 25,651 2002 461,782 - 2003 473,200 - 2004 487,396 - 2005 164,064 - Thereafter - - ---------- -------- Total minimum operating and capital lease payments $2,047,375 25,651 ========== Less amount representing interest (563) -------- Present value of remaining minimum capital lease payments 25,088 Less amount due in one year (25,088) -------- Long-term portion of obligations under capital leases $ - ========
Cost and accumulated depreciation of equipment held under capital leases as of December 31, 2000 was $279,497 and $201,761, respectively. The carrying amount of the Company's obligations under its capital lease agreements approximate their fair value and the implicit interest rate approximates the Company's borrowing rate. Rent expense was approximately $367,415, $417,000, $442,633, and $4,005,048 for the years ended December 31, 2000, 1999 and 1998 and for the period July 6, 1988 (inception) through December 31, 2000, respectively. 5. Income Taxes At December 31, 2000, the Company had net operating loss carryforwards of approximately $32,300,000 for federal income tax purposes, which may be applied against future income, if any, and will begin expiring in 2004 unless previously utilized. In addition, the Company had F-20 Protein Polymer Technologies, Inc. (A Development Stage Company) Notes to Financial Statements December 31, 2000 5. Income Taxes (continued) California net operating loss carryforwards of approximately $11,900,000. The California tax loss carryforwards continue to expire ($1,012,000 expired in 2000). The difference between the tax loss carryforwards for federal and California purposes is attributable to the capitalization of research and development expenses for California tax purposes, the required 50% limitation in the utilization of California loss carryforwards, and the expiration of certain California tax loss carryforwards. The Company also has federal and California research and development tax credit carryforwards of approximately $1,162,000 and $547,000, respectively, which will begin expiring in 2004 unless previously utilized. As a result of an ownership change that occurred in January 1992, approximately $2,700,000 of the Company's federal net operating loss carryforwards will be subject to an annual limitation regarding utilization against taxable income in future periods. However, the Company believes that such limitations will not have a material impact upon the utilization of the carryforwards. Significant components of the Company's deferred tax assets as of December 31, 2000 are shown below. A valuation allowance of $13,943,000 has been recognized to offset the deferred tax assets as realization of such assets is uncertain. 2000 1999 -------------------------------- Deferred tax assets: Net operating loss carryforwards $ 11,990,000 $ 11,410,000 Research and development credits 1,517,000 1,354,000 Other, net 436,000 103,000 -------------------------------- Total deferred tax assets 13,943,000 12,867,000 Valuation allowance for deferred tax assets (13,943,000) (12,867,000) -------------------------------- Net deferred tax assets $ - $ - ================================
6. Employee Benefits Plan On January 1, 1993, the Company established a 401(k) Savings Plan for substantially all employees who meet certain service and age requirements. Participants may elect to defer up to 20% of their compensation per year, subject to legislated annual limits. Each year the Company may provide a discretionary matching contribution. As of December 31, 2000, the Company had not made a contribution to the Savings Plan. F-21 Item 8. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. PART III Items 9, 10, 11 and 12 are incorporated by reference from the Company's definitive Proxy Statement to be filed by the Company with the Commission no later than April 30, 2001. Item 13. Exhibits, Financial Statements and Reports on Form 8-K (a)(1) and (2) Financial Statements and Schedules The Financial Statements are incorporated herein as a part of Item 7. (a)(3) Exhibits The following documents are included or incorporated by reference: Exhibit Number Description ------ ----------- 3.1 (6) Certificate of Incorporation of the Company, as amended. 3.1.1 (13) Certificate of Designation of Series E Convertible Preferred Stock. 3.1.2 (13) Certificate of Designation of Series F Convertible Preferred Stock. 3.1.3 (14) Certificate of Designation of Series G Convertible Preferred Stock. 3.2 (6) Bylaws of the Company, as amended. 10.1 (1) 1989 Stock Option Plan, together with forms of Incentive Stock Option Agreement and Nonstatutory Option Agreement. 10.2 (4) 1992 Stock Option Plan of the Company, together with forms of Incentive Stock Option Agreement and Nonstatutory Option Agreement. 27 10.3 (1) Form of Employee's Proprietary Information and Inventions Agreement. 10.4 (1) Form of Consulting Agreement. 10.5 (1) Form of Indemnification Agreement. 10.6 (4) License Agreement, dated as of April 15, 1992, between the Board of Trustees of the Leland Stanford Junior University and the Company. 10.7 (6) Amended and Restated Registration Rights Agreement dated September 14, 1995, among the Company and the holders of its Series D Preferred Stock. 10.8 (6) Securities Purchase Agreement related to the sale of the Company's Series D Preferred Stock. 10.9 (7) Letter Agreement dated as of October 4, 1996 between the Company and MBF I, LLC ("MBF") relating to the provision of consulting and advisory services. 10.10 (7) Form of Warrant with respect to a warrant for 50,000 shares issued to MBF, and to be used with respect to additional warrants which may be issued to MBF. 10.11 (7) Registration Rights Agreement dated as of October 4, 1996 between the Company and MBF. 10.12 (7) Securities Purchase Agreement dated as of January 6, 1997 among the Company and the investors named therein relating to the sale and purchase of 1,904,000 shares of the Company's common stock. 10.13 (8) Lease, with exhibits, dated March 1, 1996 between the Company and Sycamore/San Diego Investors. 10.14 (8) Second Amendment to Lease between the Company and Sycamore/San Diego Investors, dated March 1, 1996. 10.15 (8) 1996 Non-Employee Directors' Stock Option Plan. 10.16 (9) Stockholder Protection Agreement, dated August 22, 1997, between the Company and Continental Stock Transfer & Trust Company as rights agent. 28 10.17 (10) Employee Stock Purchase Plan, together with Form of Stock Purchase Agreement. 10.18 (11) Lease, with rider and exhibits, dated April 13, 1998, between the Company and Sycamore/San Diego Investors 10.19 (12) First Amendment to Stockholder Protection Agreement dated April 24, 1998, between the Company and Continental Stock Transfer & Trust Company as rights agent. 10.20 (13) Securities Purchase Agreement related to the sale of the Company's Series E Convertible Preferred Stock dated as of April 13, 1998 among the Company and Investors named therein related to the purchase of 54,437.50 shares of Series E Preferred Stock. 10.21 (13) Form of First Warrants to purchase Common Stock related to the sale of the Company's Series E Preferred Stock. 10.22 (13) Form of Second Warrants to purchase Common Stock related to the sale of the Company's Series E Preferred Stock. 10.23 (13) Letter of Agreement dated April 13, 1998 between the Company and Johnson & Johnson Development Corporation for the exchange of up to 27,317 shares of Series D Preferred Stock for a like number of shares of Series F Preferred Stock. 10.24 (14) Securities Purchase Agreement related to the sale of the Company's Series G Convertible Preferred Stock 10.25 (14) Form of Warrant to Purchase Common Stock issued in connection with the Series G Preferred Stock 10.26 (14) Second Amendment to Stockholder Protection Agreement, dated July 26, 1999 between the Company and Continental Stock Transfer and Trust Company as rights agent 10.27 (15) License and Development Agreement dated as of January 26, 2000 between the Company and Prospectivepiercing Limited, to be known as Femcare Urology Limited. 10.28 (15) Supply Agreement dated as of January 26, 2000 between the Company and Femcare Urology Limited. 10.29 (15) Escrow Agreement dated as of January 26, 2000 between the Company and Femcare Urology Limited. 29 10.30 (15) Employment Agreement, dated as of February 17, 2000, between the Company and J. Thomas Parmeter. 10.31 (15) Employment Agreement, dated as of February 17, 2000, between the Company and John E. Flowers. 10.32 (15) Employment Agreement, dated as of February 17, 2000, between the Company and Joseph Cappello. 10.33 (15) Employment Agreement, dated as of February 17, 2000, between the Company and Franco A. Ferrari. 10.34 (15) License Agreement dated as of February 18, 2000 between the Company and Sanyo Chemical Industries, Ltd. 10.35 License Agreement dated December 21, 2000 between the Company and Genencor International, Inc. 10.36 Form of Warrant to Purchase Common Stock issued in connection with License Agreement between the Company and Genencor International, Inc. 23.1 Consent of Ernst & Young LLP, Independent Auditors 30 (1) Incorporated by reference to the Company's Registration Statement on Form S-1 (No. 33-43875) filed with the Commission on November 12, 1991, as amended by Amendments Nos. 1, 2, 3 and 4 thereto filed on November 25, 1991, December 23, 1991, January 17, 1992 and January 21, 1992, respectively. (2) Incorporated by reference to Registrant's Report on Form 10-Q for the quarter ended March 31, 1992, as filed with the Commission on May 14, 1992. (3) Incorporated by reference to Registrant's Report on Form 10-Q for the quarter ended September 30, 1992, as filed with the Commission on November 13, 1992. (4) Incorporated by reference to Registrant's Report on Form 10-K for the fiscal year ended December 31, 1992, as filed with the Commission on March 31, 1993. (5) Incorporated by reference to Registrant's Report on Form 10-KSB for the fiscal year ended December 31, 1994, as filed with the Commission on March 30, 1995. (6) Incorporated by reference to Registrant's Report on Form 10-Q for the quarter ended September 30, 1995, as filed with the Commission on October 24, 1995. (7) Incorporated by reference to Registrant's current Report on Form 8-K, as filed with the Commission on January 7, 1997. (8) Incorporated by reference to Registrant's Report on Form 10-KSB for the fiscal year ended December 31, 1996, as filed with the Commission on March 27, 1997. (9) Incorporated by reference to Registrant's Current Report on Form 8-K, as filed with the Commission on August 27, 1997. (10) Incorporated by reference to Registrant's Report on Form 10-KSB for the fiscal year ended December 31, 1997, as filed with the Commission on April 9, 1998. (11) Incorporated by reference to Registrant's Report on Form 10-Q for the quarter ended March 31, 1998, as filed with the Commission on May 14, 1998. (12) Incorporated by reference to Registrant's Report on Form 10-Q for the quarter ended June 30, 1998, as filed with the Commission on August 13, 1998. (13) Incorporated by reference to Registrant's Report on Form 10-KSB for the fiscal year ended December 31, 1998, as filed with the Commission on April 9, 1999. (14) Incorporated by reference to Registrant's Report on Form 10-Q for the quarter ended September 30, 1999, as filed with the Commission on November 12, 1999. (15) Incorporated by reference to Registrant's Report on Form 10-KSB for the fiscal year ended December 31, 1999, as filed with the Commission on March 24, 2000. 31 (b) Reports on Form 8-K. On February 3, 2000, the Company filed a Current Report on Form 8-K with the Commission. In Item 5 of the Report, the Company reported the establishment of a strategic partnership with Femcare, Ltd., including the execution of a License and Development Agreement, a Supply Agreement, and an Escrow Agreement which in combination granted Femcare Ltd. the exclusive right to commercialize the Company's urethral bulking agents in Europe and Australia. 32 SIGNATURE In accordance with Section 13 or 15(d) of the Exchange Act, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. PROTEIN POLYMER TECHNOLOGIES, INC. February 21, 2001 By /S/ J. THOMAS PARMETER ----------------------- J. Thomas Parmeter Chairman of the Board, Chief Executive Officer, President In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Capacity Date - --------- -------- ---- /S/ J. THOMAS PARMETER Chairman of the Board, Chief February 21, 2001 - ----------------------- Executive Officer, President J. Thomas Parmeter /S/ JANIS Y. NEVES Director of Finance, Controller, February 21, 2001 - ------------------- and Assistant Secretary Janis Y. Neves /S/ RICHARD ADELSON Director February 21, 2001 - -------------------- Richard Adelson /S/ PATRICIA J. CORNELL Director February 21, 2001 - ------------------------ Patricia J. Cornell /S/ EDWARD E. DAVID Director February 21, 2001 - --------------------- Edward E. David, Ph.D. /S/ PHILIP J. DAVIS Director February 21, 2001 - -------------------- Philip J. Davis /S/ EDWARD J. HARTNETT Director February 21, 2001 - ----------------------- Edward J. Hartnett /S/ J. PAUL JONES Director February 21, 2001 - ------------------ J. Paul Jones, Ph.D. 33 /S/ KERRY L. KUHN Director February 21, 2001 - ------------------ Kerry L. Kuhn, M.D. /S/ GEORGE R. WALKER Director February 21, 2001 - --------------------- George R. Walker 34
EX-10.35 2 0002.txt LICENSE AGREEMENT DATED DECEMBER 21, 2001 EXHIBIT 10.35 License Agreement This Agreement made as of this 21st day of December, 2000 ("Effective Date") by and between Genencor International, Inc., a Delaware corporation with its principal place of business at 925 Page Mill Road, Palo Alto, CA 94304 ("GCOR") and Protein Polymer Technologies, Inc., a Delaware corporation with its principal place of business at 10655 Sorrento Valley Road, San Diego, CA 92121 ("PPT"). WHEREAS, PPT has developed certain technology, know-how and intellectual property relating to recombinant, repetitive unit proteins and peptides and is willing to license said technology, know-how and intellectual property to GCOR; WHEREAS, GCOR desires to obtain an exclusive license to said technology, know- how and intellectual property relating to recombinant, repetitive unit proteins and peptides from PPT; WHEREAS, PPT and GCOR have entered into a Confidential Disclosure Agreement, Effective Date August 2, 1999, as amended, pursuant to which the parties have been discussing terms and conditions for a license and now wish to conclude such a transaction; NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the parties agree as follows: Article I - Definitions The following definitions shall control the construction of each of the following terms wherever they appear in this Agreement: 1.1 "Additional Application Fields" shall mean the use of a Licensed Product in any application within the Field but outside the specific Application Fields enumerated in Section 1.2. 1.2 "Application Fields" shall mean the use of a Licensed Product(s) in the following (i) production or processing of **; (ii) **; (iii) industrial **; (iv) **; (v) ** technology; (vi) ** devices; or (vii) ** materials. 1.3 "Confidential Information" shall mean all information of either party related to Licensed Rights or a Licensed Product or otherwise designated as confidential by the disclosing party ("Discloser") which the Discloser provides to the other party ("Recipient") in accordance with the terms of this Agreement, in writing and designated as confidential or, if originally disclosed orally or otherwise, is reduced to writing marked as confidential and provided to the Recipient within thirty (30) days of the disclosure. 1.4 "Core Product" shall mean one or more Licensed Products characterized by substantially similar repeat units arranged in a defined sequence. A single Core Product therefore would encompass for example the following repeat units: A-B-A-A-B-C and A-B-A'-A-B-C (where the amino acid sequence of repeat unit A' is substantially similar to the amino acid sequence of repeat unit A). 1.5 "Date of First Commercial Sale (DFCS)" shall mean in respect of each Licensed Product the first arm's length transaction with a willing buyer for the sale of such Licensed Product into the market place for commercial uses by GCOR or its sublicensee. ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 1 1.6 "Field" shall mean the research, development, production and/or sale of products or processes incorporating Licensed Patents or Licensed Know-How for any and all applications including but not limited to the Application Fields but excluding those applications that are subject to regulation in the United States under the Food, Drug and Cosmetics Act, the Medical Devices Act and any amendments or updates thereto (these regulated applications hereinafter referred to as the "Health Care Field"). 1.7 "Licensed Know-How" shall mean any proprietary and confidential know-how owned or controlled by PPT on the Effective Date, including technical data, experimental results, techniques, methods, technology, processes, recipes and written materials related to recombinant, repetitive unit proteins and peptides as well as gene construction, protein polymer and corresponding DNA sequences, polymer production systems, acceptor vectors, plasmids, polymer gene and gene monomers, maps and DNA sequences for all plasmid constructs, host production cells, fermentation and recovery/purification protocols, and applications or use data of such proteins and protein polymers. 1.8 "Licensed Patents" shall mean patent applications owned or controlled by PPT as of the Effective Date as listed in Exhibit 1.8 attached hereto and any patents issued on any such patent applications and including any reissued patents, re-examined patents, divisions, renewals, continuations and continuations in part, substitutions, extensions or foreign counterparts thereof. 1.9 "Licensed Products" shall mean any product or process derived by, expressed, made or produced using the Licensed Rights within an Application Field or Additional Application Field. 1.10 "Licensed Rights" shall mean collectively PPT's Licensed Patents and Licensed Know-How. 1.11 "Net Sales" shall mean with respect to a Licensed Product, the ** or its subsidiaries (on a **) to unrelated third parties for a Licensed Product, less: ** ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 2 1.12 ** 1.13 ** 1.14 ** Article II - Grant of License 2.1 Subject to GCOR's compliance with the terms and conditions of this Agreement, for a period of eighteen (18) months from the Effective Date (the "Initial Grant Period") PPT hereby grants to GCOR a worldwide, royalty-bearing (in accordance with Article III below), exclusive (except as to pre-existing rights to license granted within the Field as specified in Exhibit 2.1 attached hereto) and sublicenseable (in accordance with Section 2.2 below) right and license to practice the Licensed Patents and Licensed Know-How to make, have made, use, promote, market, distribute, import and sell Licensed Products within the Field. Provided further that: ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 3 (a) Upon expiration of the Initial Grant Period for the remainder of the term of this Agreement, GCOR's exclusive license will automatically convert to a worldwide, royalty-bearing (in accordance with Article III below), exclusive and sublicenseable (in accordance with Section 2.2 below) right and license to practice the Licensed Patents and Licensed Know-How to make, have made, use, promote, market, distribute, import and sell Licensed Products within the Application Fields and, beginning on the date of addition to the license in accordance with Section 2.1(b), any Additional Application Fields added at any time during the term of this Agreement, subject to the provisions of Section 3.2 and Article V of this Agreement. (b) At any time during the term of this Agreement GCOR shall have the option to expand the Application Fields to include Additional Application Fields (the "Option"). To exercise its Option GCOR shall provide PPT written notice of its intent to initiate, either on its own or with a third party, a program for the development of Licensed Product in a specified Additional Application Field. GCOR shall not have the right to exercise such Option without the prior written approval of PPT, which approval shall not be untimely or unreasonably withheld. Upon such approval by PPT, the specified Additional Application Field shall be included within GCOR's exclusive license. Should GCOR fail to initiate a development program within the specified Additional Application Field within twelve (12) months from approval by PPT, GCOR's right and license to said Additional Application Field shall lapse. (c) Furthermore, during the term of this Agreement PPT hereby grants GCOR a right of first refusal for the development, manufacture, use and sale of product(s) developed using the Licensed Rights for any use within the Field and outside the Application Field(s) and any approved Additional Application Field(s) included within GCOR's exclusive license pursuant to Section 2.1(b). Subject to GCOR's right of first refusal, in the event PPT identifies a product opportunity for development within the Field and outside the Application Fields(s) and any approved Additional Application Field(s), PPT shall prior to initiating such development itself or with a third party through a license, collaboration or otherwise provide GCOR the opportunity to develop the product. PPT shall do so by providing GCOR with a written offer that shall include, at a minimum a description of the proposed product and applications and such other information as may be reasonably available and may be necessary for GCOR to evaluate such product opportunity. GCOR shall accept or decline the offer within forty-five (45) days of its receipt of the offer. If GCOR accepts the offer the product and application field shall become subject to the terms and conditions of this Agreement. Likewise, subject to GCOR's right of first refusal, if a third party should approach PPT requesting a license or collaboration to develop a product within the Field and outside the Application Field(s) and any approved Additional Application Field(s), PPT shall provide GCOR with a written offer that shall include at a minimum, (i) a description of the proposed product and application; (ii) the proposed license or collaboration structure with respect to such product and applications; and (iii) any other applicable material terms or conditions. GCOR shall accept or decline the offer within forty-five (45) calendar days after receipt of such offer. A failure to respond shall be a decline of the offer. 2.2 GCOR shall have the right to sublicense its exclusive right and license to practice the Licensed Patents and Licensed Know-How except to the extent such relate to gene construction and polymer production technology without PPT's prior approval. GCOR shall also have the right to sublicense or otherwise transfer its exclusive right and license to practice the Licensed Patents and Licensed Know-How related to gene construction and polymer production technology to third parties as necessary for the commercialization of 4 Licensed Products subject to PPT's approval which approval shall not be unreasonably withheld. GCOR shall be responsible for compliance by sublicensees with the terms and provisions of this Agreement. 2.3 PPT retains all rights to the Licensed Rights not expressly granted to GCOR pursuant to this Agreement. Subject only to the rights granted to GCOR pursuant to this Agreement, title to the Licensed Rights shall at all times after the initial grant paeriod remain with PPT. Subject to GCOR's Option and right of first refusal pursuant to Section 2.1(b) and (c) respectively, PPT shall at all times have the right to freely use the Licensed Rights outside of the Application Field or Additional Application Fields, as applicable. In addition, PPT, in its sole discretion, shall have the right to use or license the Licensed Rights to any third parties for uses in the Health Care Field. Periodically and at least one time per year the parties will meet and discuss their respective efforts with the Licensed Rights including any modifications, enhancements and improvements to the Licensed Rights ("Improvements") which have been made by either party. To the extent that GCOR makes any Improvements which may be useful in the Health Care Field, the parties will discuss and agree on how to commercialize such Improvements in the Health Care Field. Article III - Fees and Royalties 3.1 Upfront Payment. Within fifteen (15) days of the Effective Date, GCOR ---------------- shall pay PPT a lump sum non-refundable payment of Seven Hundred and Fifty Thousand US Dollars ($750,000). 3.2 Milestone Payments. In consideration of PPT entering into this Agreement ------------------- and the right and licenses granted to GCOR hereunder, during the term of this Agreement, GCOR will pay PPT certain milestone payments (the "Milestone Payments") as detailed below: ** 3.3 Royalties. Prior to commercialization of any Licensed Product GCOR and PPT --------- shall in good faith agree on the applicable PPT Intellectual Property Class (Class I-IV) of the Core Product embodied in the proposed Licensed Product. For each Royalty Payment due under this Agreement: (i) the weighted average selling price of Licensed Product will be determined, which together with the PPT Intellectual Property Class determination results in a Selling Price Multiplier; and (ii) actual annual Net Sales of each Licensed Product will be determined and summed to yield the Core Product Net Sales, which together with the PPT Intellectual ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 5 Property Class determination results in a Net Sales Multiplier. For illustrative purposes only, a hypothetical determination of the weighted average selling price for Licensed Product and Core Product Net Sales are set forth in Exhibit 3.3. (a) Royalties on GCOR Sales of Licensed Product. Taking each of these ------------------------------------------- factors into consideration the Net Effective Royalty Rate payable by GCOR on Net Sales of a Licensed Product will be calculated using the following formula: Net Effective Royalty Rate=(royalty rate for applicable PPT Intellectual Property Class) X (Selling Price Multiplier) X (Net Sales Multiplier). The Net Effective Royalty Rate for each Licensed Product will be multiplied by GCOR's Net Sales of the Licensed Product to calculate the royalty payable to PPT. For illustrative purposes only, hypothetical calculations of Net Effective Royalty Rates are set forth in Exhibit 3.3(a). (b) Royalties for Third Party Sales of Licensed Product. In the event a --------------------------------------------------- third party licensee sells Licensed Product the Net Effective Royalty Rate shall be calculated in the same manner as detailed in section 3.3 (a), however rather than multiplying the Net Effective Royalty Rate by GCOR's Net Sales, the Net Effective Royalty Rate shall be multiplied by GCOR's share or interest in the Licensed Product or the Licensed Product-related revenue from the third parties' sales of Licensed Product. 3.4 Third Party Royalty Obligations. Except as provided in Section 3.4(a) -------------------------------- below, GCOR's total royalty rate for a Licensed Product will not exceed **. Accordingly if the manufacture, use or sale of a Licensed Product requires one or more license(s) to third party intellectual property in addition to PPT Licensed Rights, PPT's Net Effective Royalty Rate shall be reduced by the royalty rate due by GCOR to said third party(s) so that GCOR's total royalty rate does not exceed **. (a) ** Article IV- Payments and Reports 4.1 Net Sales Records; Reports. GCOR shall keep complete and correct records --------------------------- of Net Sales of Licensed Products sold by GCOR for a period of three (3) years after the making of a royalty payment under this Agreement. Annually, GCOR will provide PPT a report summarizing any susblicensing arrangements, joint ventures, strategic alliances or other partnering arrangements and any third party activity relating to the Licensed Rights. 4.2 Royalty Payments for GCOR sales. Royalty payments shall be made within -------------------------------- thirty (30) days of the end of each calendar quarter during the term of this Agreement. Accordingly, royalty payments under this Agreement shall become due and payable on each April 30, July 31, October 31 and January 31 for the preceding quarter. Royalties for the first three (3) quarters will be pro-rated based on projected annual Net Sales. At the end of the calendar year when actual annual Net Sales information is available, GCOR will adjust up or down the fourth quarter payment to reconcile projected Net Sales and actual Net Sales and the royalties due. Payment shall be accompanied by a report showing the gross receipts from sales of Licensed Products less the deductions permitted in Section 1.11 and the resulting Net Sales used in the ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 6 computation of the royalty payments as well as any reductions in the royalty obligation of GCOR pursuant to Section 3.4. 4.3 Payments for Third Party Sales. If product revenue is generated by GCOR's ------------------------------- sublicensee's sale of Licensed Product or the sale of Licensed Product by any other entity including, without limitation, pursuant to a joint venture, strategic alliance or other partnering arrangement, rather than GCOR's direct sale of such Licensed Product, and GCOR therefore receives its revenue or any other form of payment based on any third party's product-related revenue, then GCOR shall keep complete and correct records of payments received by it based on product-related revenues. 4.4 Currency and Exchange Rates. GCOR shall make all payments to PPT under ---------------------------- this Agreement in US Dollars and to a bank account to be designated by PPT. Net Sales shall be calculated on the basis of the rates of exchange as quoted by the Wall Street Journal (US Edition) using the weighted average ------------------- exchange rate of the calendar year royalty period in which the corresponding sales of Licensed Product were made. 4.5 Audit. GCOR shall allow PPT to appoint a firm of independent certified ----- public accountants to whom GCOR has no reasonable objection. GCOR shall give such accountants access, during ordinary business hours and subject to a reasonable advance notice, to such books, records and personnel of GCOR as are necessary to verify the accuracy of any royalty or equivalent payment made or payable under the Agreement. Such access shall be granted no more than once in a calendar year, at PPT's request and expense. The independent certified accountants will be under a confidentiality obligation to GCOR to disclose to PPT in its report only the amount of royalties payable under the Agreement. If the results of any such audit reveal a net underpayment by GCOR to PPT of amounts due pursuant to this Agreement, then GCOR shall within thirty (30) calendar days of receipt of notice by GCOR of such underpayment pay to PPT (i) the amount of such underpayment plus interest accrued at the lower of (a) the rate of prime rate plus one percent (1%) per annum and (b) the highest rate allowed by applicable law and (ii) the reasonable costs and expenses incurred by PPT in connection with such audit. If the results of such audit reveal a net overpayment by GCOR to PPT of any amounts due pursuant to this Agreement, then GCOR shall receive a credit in the amount of such overpayment against any royalty payments due to PPT. Article V - ** 5.1 GCOR's ** license as granted in Article III will ** license subject to Section 5.2 hereof if GCOR fails to make a combined Minimum Payment arising from either (i) Milestone Payments and Royalties but excluding the Seven Hundred and Fifty Thousand US Dollars ($750,000) upfront fee; or (ii) a lump sum payment to PPT as follows: ** ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 7 5.2 If GCOR fails to make the combined Minimum Payments in the time periods set forth whether through Milestone Payments and Royalties or lump sum payments in the relevant time period specified in Section 5.1 (a)-(c) then GCOR's ** license shall be ** license to develop, make, have made, use, promote, import and sell Licensed Products, the development of which has already been initiated, in the applicable Application Fields and Additional Application Fields . Article VI - Technology Transfer 6.1 Promptly after the Effective Date PPT shall transfer the Licensed Know-How to GCOR as specified in that certain letter dated December 21, 2000 from PPT to GCOR. In consideration of the fees paid by GCOR this transfer shall be free of additional charge and shall include costs incurred by PPT associated with up to three (3) days of consultation by PPT research and development personnel to enable the effective and efficient transfer of the Licensed Know How to GCOR. In addition to the initial transfer, GCOR may request at its expense additional consulting from PPT personnel up to an additional five (5) days. GCOR will bear reasonable and customary consultation fees for any such additional consulting requested. Article VII - Warrants 7.1 PPT shall grant warrants to GCOR pursuant to definitive warrant agreements attached hereto ** as follows: (a) Stock warrants for shares of PPT common stock valued at Five Hundred Thousand US Dollars ($500,000) ** (b) Stock warrants for shares of PPT common stock valued at Five Hundred Thousand US Dollars ($500,000) ** Article VIII - Representations and Warranties and Indemnification 8.1 Representation and Warranties By PPT. PPT represents and warrants to GCOR ------------------------------------- that: (a) it has the authority to enter into this Agreement; (b) it owns the Licensed Rights and/or has the right to grant to GCOR the license granted under Article II hereof and that said licenses do not conflict with or violate the terms of any agreement between PPT and any third party; (c) there is no ongoing administrative or judicial proceeding contesting the inventorship, ownership, validity or enforceability of any element of the Licensed Rights nor has there been any such administrative or judicial proceeding in the past; ** Material is confidential and has bee omitted and filed separately with the Securities and Exchange Commission. 8 (d) it has not as of the Effective Date, granted the right to license the Licensed Rights to any third party in the licensed Field except as disclosed in Exhibit 2.1; and (e) PPT has no third party agreements which would be violated by the disclosure or transfer to GCOR of Licensed Know-How. 8.2 Representations and Warranties By GCOR. GCOR represents and warrants to --------------------------------------- PPT that: (a) GCOR has the authority to enter into this Agreement; (b) this Agreement does not conflict with the terms of any other agreement to which it is subject; and (c) GCOR is in compliance with: (i) all laws applicable to the purchase, storage, transport, labeling, distribution or commercialization by it of the Licensed Product, Licensed Know-How and Licensed Patents; (ii) the U.S. Export Administration laws and regulations and shall not export or re-export any technical data or intellectual property, or the direct products of such technical data or intellectual property, or Licensed Product to any prohibited country listed in the U.S. Export Administration Regulations unless properly authorized to do so by the U.S. government. 8.3 Indemnification by PPT. PPT shall defend, indemnify and hold GCOR harmless ----------------------- against any liability, damage, cost or expense, including reasonable legal fees arising out of or resulting from: (i) PPT's breach of a material term of this Agreement; (ii) PPT's breach of any representation or warranty set forth in Section 8.1; and (iii) any third person claim(s) or suit(s) made or brought against GCOR to the extent such liability arises out of or relates to PPT's gross negligence or willful misconduct with regard to the licenses granted herein by PPT to GCOR or the transfer of Licensed Know-How hereunder by PPT. 8.4 Indemnification by GCOR. GCOR shall defend, indemnify and hold PPT ------------------------ harmless against any liability, damage, cost or expense, including reasonable legal fees arising out of or resulting from: (i) GCOR's breach of a material term of this Agreement; (ii) GCOR's breach of any representation or warranty set forth in Section 8.2; and (iii) any third person claim(s) or suit(s) made or brought against PPT to the extent such liability arises out of or relates to GCOR's manufacture, use or sale of Licensed Products or use of the PPT Licensed Rights, except to the extent such liability is the result of PPT's gross negligence or willful misconduct. 8.5 Notice and Cooperation. If either party receives notice of any claim or of ---------------------- the commencement of any action, administrative or legal proceeding, or investigation as to which the indemnity provided for in Section 8.3 or 8.4 hereof may apply: (a) the party seeking indemnification shall notify the indemnifying party of such fact within fourteen (14) days at the address noted in Section 13.7; provided that the failure to so notify shall not release an indemnifying party of its obligations hereunder unless such failure shall be materially detrimental to the defense of any such action, proceeding or investigation; and (b) the party seeking indemnification shall cooperate with and assist the indemnifying party and its representatives in the investigation and defense of any claim and/or suit for which indemnification is provided. 8.6 Defense and Settlement. The indemnifying party shall control the defense ----------------------- of any claim and/or suit for which indemnification is provided under this Article VIII. This agreement of 9 indemnity shall not be valid as to any settlement of a claim or suit or offer of settlement or compromise without the prior written approval of the indemnifying party. 8.7 Limitation on Damages. Notwithstanding any provision in this Agreement to ---------------------- the contrary, in no event will PPT or GCOR be liable for special, exemplary, incidental or consequential damages or for damages of any kind based upon the loss of revenue or anticipated profits. Article IX - Collaboration Agreement 9.1 Collaboration Agreement. At any time within three (3) years of the ------------------------ Effective Date of the Agreement at GCOR's request and discretion, it may notify PPT of its intent to enter a subsequent funded research and development collaboration agreement with PPT (the "Collaboration"). If GCOR provides timely notice to PPT and the parties commence such a Collaboration no sooner than the second year of the License Agreement, then PPT shall make personnel available for funded research and development of up to Five Hundred Thousand US Dollars ($500,000) over a twelve (12) month funding period. Any such Collaboration shall be memorialized in a definitive agreement including a work plan detailing the efforts to be undertaken in the program as well as terms and conditions for GCOR's funding and such other terms and conditions as the parties mutually agree upon. All intellectual property rights arising from such a Collaboration shall be licensed to GCOR under reasonable terms and conditions and in no event under terms less favorable than those included herein. Furthermore said terms and conditions shall take into consideration GCOR's funding of the Collaboration. Notwithstanding the foregoing, PPT shall have no obligation whatsoever to enter into the Collaboration if GCOR is in breach of any provision of this Agreement. Article X - Patent Maintenance, Prosecution and Enforcement 10.1 PPT, at its expense, shall use commercially reasonable efforts to prosecute and maintain the Licensed Patents only in **. PPT will provide GCOR an update on the status of all Licensed Patents periodically (not to exceed two times per calendar year) upon GCOR's reasonable request. 10.2 In the event that GCOR provides PPT with written notice of and evidence establishing a substantial case of infringement of a Licensed Patent by a third party with a product similar to a Licensed Product which infringing product is made, used or sold using Licensed Rights, PPT may at its sole discretion within thirty (30) days of receipt of such notice and evidence take action it deems appropriate to abate such infringement. If PPT elects to take action against such infringement, at GCOR's discretion it may advance to PPT one-half of the total costs and expenses related to such action and in return receive a credit against royalty payments due PPT for all such advanced amounts. In addition, GCOR shall render all reasonable assistance in connection therewith including being named as a party, if necessary. In such an event, GCOR shall have the right to be represented in that action by counsel of its own choice and at GCOR's expense. If PPT fails to take action against such infringement or possible infringement, GCOR to the extent allowable by law shall have the right at its sole discretion to take any necessary action against such infringement or possible infringement. In no event shall GCOR settle or abate such infringement by granting any rights to Licensed Patents without the prior written consent of PPT. If GCOR elects to take action against such infringement, PPT shall render all reasonable assistance to GCOR, at PPT's cost and expense in connection therewith including being named as a party, if necessary. In such event, PPT shall have the right to be ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 10 represented by counsel of its own choice and at PPT's expense. Alternatively, at its sole discretion, PPT may assign to GCOR all of its right, title and interest in the relevant Licensed Patent(s). The party enforcing any Licensed Patent shall bear the cost and shall have the right to any sum recovered in such proceedings in proportion to its costs in such proceeding. Article XI - Confidentiality 11.1 In consideration of disclosure by either of the parties to the other party of Confidential Information, the Recipient undertakes for the term of this Agreement and five (5) years thereafter to treat received information as strictly secret and therefore not to disclose it to any third party (except reliable employees and affiliates and sublicensees under similar secrecy obligations), and to make no commercial use of it except for the purposes of this Agreement or except as otherwise specifically provided for herein. This obligation does not apply to: (a) information which, at the time of disclosure, is already in the public domain; (b) information which, after disclosure, becomes a part of the public domain by publication through no violation of this Agreement; (c) information which the Recipient is able to prove by competent written evidence to have been in the Recipient's possession prior to any disclosure by the Discloser; (d) information which is hereafter lawfully disclosed by a third party to the Recipient, which third party did not acquire the information under a still effective obligation of confidentiality to the Discloser; and (e) information which is independently developed by or for a party. 11.2 Press Release. Neither party shall issue any public statement concerning ------------- the existence or terms of this Agreement or any activities related hereto without consulting and agreeing with the other party on the nature, text and timing of such public statement. However, each party may disclose this Agreement or any activities related hereto without the other party's approval if such approval has been requested but not received within forty- eight (48) hours and such party concludes, after consulting with its legal advisors, that it is required by law or regulatory or listing agency to disclose the transaction or part thereof. Furthermore, GCOR shall be free to disclose through a press release or otherwise any third party transaction(s) it concludes relating to the Licensed Rights without PPT's approval. GCOR will endeavor but is not obligated to provide PPT with prior notice of such proposed disclosure and to acknowledge PPT as GCOR's licensor of the Licensed Rights. Article XII - Term & Termination 12.1 Term. This Agreement shall commence on the Effective Date and shall ---- continue until expiry of the last remaining Licensed Patent, unless earlier terminated in accordance with this Article XII. 12.2 Termination. Either party hereto shall have the right, by notice in ----------- writing, to terminate this Agreement: 11 (a) in the event that the other party is in default or breach of any material covenant, undertaking or obligation to be performed by that party hereunder including but not limited to (i) breach of the license terms under Article II such as use of the Licensed Rights outside the Field, (ii) breach of any of the payment provisions under Article III, (iii) breach of the representation and warranties under Article VIII, (iv) breach of confidentiality undertakings under Article XI, and such default or breach is not corrected or cured within for a non-monetary breach sixty (60) days after written notice thereof has been given by the non-defaulting party or for a monetary breach thirty (30) days after written notice thereof has been given by the non-defaulting party; or (b) in the event that the other party shall enter into any arrangement or composition with its creditors, or enter or be put into voluntary or compulsory liquidation (except for the purpose of any reorganization reasonably acceptable to the other party), or have its business enjoined into receivership by executive or judicial authorities. 12.3 GCOR shall be ** .Upon termination of this Agreement, GCOR shall immediately destroy and certify such destruction in writing to PPT, or return to PPT, all materials provided by PPT to GCOR under this Agreement, including, without limitation, all materials related to Licensed Know-How, Licensed Patents and Licensed Products. 12.4 Any termination under this Article shall be without prejudice to the rights of either party against the other then accruing or otherwise accrued under the Agreement. 12.5 Expiration of this Agreement pursuant to Section 12.1 or termination of this Agreement pursuant to Section 12.2 or 12.3 shall terminate all outstanding obligations and liabilities between PPT and GCOR arising from this Agreement except: (a) obligations to pay royalties and other sums accruing hereunder up to the day of such termination; (b) the right to complete the manufacture and sale of Licensed Products which qualify as "work in progress" under generally accepted cost accounting standards or which are in stock at the date of termination, and the obligation to pay royalties on Net Sales of such Licensed Products; (c) obligations for record keeping and accounting reports for so long as Licensed Product is sold pursuant to this Agreement; (d) PPT's right to inspect books and records as in Section 4.5; (e) Representations and warranties and indemnity under Article VIII shall survive for a period of three (3) years after the date of expiration or termination of this Agreement; (f) Any cause of action or claim of GCOR and sublicensees or PPT accrued or to accrue because of any breach or default by the other party hereunder; (g) The confidentiality provisions of Article XI; ** Materials is confidential and has veen omitted and filed seperately with the securities and Exchange Commission. 12 (h) All other terms, provisions, representation, rights and obligations contained in this Agreement that by their sense and context are intended to survive until performance thereof by either or both parties. Article XIII - Miscellaneous Provisions 13.1 Force Majeure. Each of the parties hereto shall be excused from the ------------- performance of its obligations hereunder and shall not be liable for damages to the other in the event that such performance is prevented by circumstances beyond its effective control. Such excuse from performance shall continue for as long as the condition responsible for such excuse continues and for a period of thirty (30) days thereafter, provided that if such excuse continues for a period of one hundred and eighty (180) days, the party whose performance is not being prevented shall be entitled to withdraw from this Agreement. For the purpose of this Agreement circumstances beyond the effective control of the party which excuse said party from performance shall include, without limitation, acts of God, enactments, regulations or laws of any government, injunctions or judgment of any court, war, civil commotion, destruction of facility or materials by fire, earthquake, storm or other casualty, labor disturbances and failure of public utilities or common carrier. 13.2 Non-Solicitation. As a material inducement to PPT executing, delivering ---------------- and performing this Agreement, for a period of ** after the Effective Date GCOR agrees that it will not (i) solicit or attempt to solicit any employee of PPT to terminate his or her employment with PPT, or (ii) employ or solicit employment elsewhere of any employee or consultant of PPT, in each case without the prior written consent of PPT. 13.3 Independent Contractors. Nothing in this Agreement is intended or shall ----------------------- be deemed to constitute a partnership, agency, employment or joint venture relationship between the parties. All activities by the parties hereunder shall be performed by the parties as independent parties. Neither party shall incur any debts or make any commitment for or on behalf of the other party except to the extent, if at all, specifically provided herein or subsequently agreed upon. 13.4. Limitation On Assignment. Except as provided herein, neither party may ------------------------ assign this Agreement nor any interest or obligation hereunder except with the prior written consent of the other party, which consent shall not be unreasonably or untimely withheld. Either party may assign this Agreement in connection with the sale or transfer of all or substantially all of its business to which this Agreement relates without consent but with timely notice. Any permitted assignee shall assume all of the obligations of its assignor under this Agreement. 13.5 Amendments of Agreement. This Agreement may be amended or modified or one ----------------------- or more provisions hereof waived only by a written instrument signed by both parties. 13.6 Severability. In the event that any one or more of the provisions of this ------------ Agreement should for any reason be held by any court or authority having jurisdiction over this Agreement and the parties to be invalid, illegal or unenforceable, such provisions shall be deleted in such jurisdiction; elsewhere this Agreement shall not be affected. 13.7 Article Headings. The section headings contained in this Agreement are for ---------------- convenience only and are to be of no force or effect in construing and interpreting this Agreement. 13.8 Notices. Any notice, report, request, approval, payment, consent or other ------- communication required or permitted to be given under this Agreement shall be in writing and shall for all purposes ** Materials is confidential and has been omitted and filed seperately with the securities and Exchange Commission. 13 be deemed to be fully given and received, if delivered in person or sent by registered mail, postage prepaid or by facsimile transmission to the respective parties at the following addresses: If to PPT: Protein Polymer Technologies, Inc. 10655 Sorrento Valley Road San Diego, CA 92121 Telefax: 858-558-6477 Attention: President If to Genencor: Genencor International, Inc. 925 Page Mill Road Palo Alto, CA 94304 Telefax: 650-845-6507 Attention: Senior Vice President Commercial & Legal Affairs Either party may change its address for the purpose of this Agreement by giving the other party written notice of its new address. 13.9 Arbitration of Disputes. Excepting only actions and claims relating to ----------------------- actions commenced by a third party against PPT or GCOR (including, without limitation, for injuries caused by a Licensed Product or in respect to a trademark or patent infringement claim), any controversy or claim arising out of or relating to the terms and conditions of this Agreement, or the decision to agree upon these terms, or the breach thereof, including questions of validity or termination hereof, shall be settled exclusively by arbitration in accordance with the rules of the American Arbitration Association. If such controversy or claim relates to patent validity then the Patent Arbitration Rules of the AAA shall apply; otherwise the Commercial Arbitration Rules of the AAA shall apply. There shall be one (1) arbitrator to be mutually agreed upon by the parties and to be selected from the Regional Panel of Distinguished Neutrals or such other source as the parties agree. If the parties are unable to agree upon such an arbitrator who is willing to serve within forty-five (45) days of receipt of the demand by the other party, then the AAA shall appoint an arbitrator willing to serve from the stated panel, or if no such panel exists, then from an appropriate AAA panel. It shall be the duty of the arbitrator to set dates for preparation and hearing of any dispute and to expedite the resolution of such dispute. The requirements for arbitration are as follows: (a) The arbitration shall be held in the City of Los Angeles, State of California, U.S.A. and the arbitrator shall apply the substantive law of California except that the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act; (b) The arbitrator shall permit and facilitate discovery, which will be conducted in accordance with the Federal Rules of Civil Procedure, taking into account the needs of the parties and the desirability of making discovery expeditious and cost-effective; (c) The arbitrator will set a discovery schedule with which the parties will comply and attend depositions if requested by either party; 14 (d) The arbitrator will entertain such presentation of sworn testimony or evidence, written briefs and/or oral argument as the parties may wish to present, but no testimony or exhibits will be admissible unless the adverse party was afforded an opportunity to examine such witness and to inspect and copy such exhibits during the pre-hearing discovery phase; (e) The arbitrator shall among his other powers and authorities, have the power and authority to award interim or preliminary relief; (f) The arbitrator shall not be empowered to award either party exemplary, consequential or punitive damages and the parties shall be deemed to have waived any right to such damages; (g) A qualified court reporter will record and transcribe the proceeding; (h) The decision of the arbitrator will be in writing and judgment upon the award by the arbitrator may be entered in any court having jurisdiction thereof; (i) Prompt handling and disposal of the issue is important. Accordingly, the arbitrator will be instructed to assume adequate managerial initiative and control over discovery and other aspects of the proceeding to schedule discovery and other activities for substantially continuous work, thereby expediting the arbitration as much as is deemed reasonable to him, but in all events to effect a final award within 365 days of the arbitrator's selection or appointment. (j) The proceedings shall be confidential and the arbitrator shall issue appropriate protective orders to safeguard both parties' confidential information. (k) The fees of the arbitrator and the AAA shall be paid as designated by the arbitrator or, if he shall not so designate, they shall be split equally between the parties. 13.10 Non-Waiver For Failure To Enforce Compliance. The express or implied -------------------------------------------- waiver by either party of a breach of any provision of this Agreement shall not constitute a continuing waiver of other breaches of the same or other provisions of this Agreement. 13.11 Applicable Law. This Agreement shall be construed and interpreted in -------------- accordance with the laws of the State of California. 15 13.12 Authority To Sign; Counterparts. Each person signing below and each ------------------------------- party on whose behalf such person executes this Agreement warrants that he, she or it as the case may be, has the authority to enter into this Agreement. This Agreement may be executed in one or more counterparts, each of which is an original but all of which, taken together, shall constitute one and the same instrument. 13.13 Cumulative Rights. The parties' rights under this Agreement are ------------------ cumulative and non-exclusive and no exercise or enforcement by either of the parties of any right or remedy hereunder shall preclude the exercise or enforcement by either party of any other right or remedy hereunder or which either party is entitled by law to enforce. 13.14 Marking. To the extent reasonably feasible GCOR agrees to mark all -------- Licensed Product(s) made, used or sold under the terms of this Agreement, or their containers, in accordance with applicable patent marking laws. IN WITNESS WHEREOF, this License Agreement has been entered into on the Effective Date. GENENCOR INTERNATIONAL, INC. Date: 12/21/00 By: /S/ -------- ---------------------- Name: Stuart L. Melton ---------------- Title: Senior Vice President --------------------- PROTEIN POLYMER TECHNOLOGIES, INC. Date: 12/21/00 By: /S/ -------- ---------------- Name: John E. Flowers --------------- Title: Vice President -------------- 16 Exhibit 1.8 Licensed Patents
U.S. Patent No. Title Issue Date **
** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 17 Exhibit 1.8 Continued Licensed Patents
U.S. Patent No. Title Issue Date ** ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission.
18 Exhibit 2.1 ** ** 2. Proteinaceous polymers containing the amino acid sequences RGD or IKVAV (defined by standard single letter amino acid designations) useful in promoting cell culture, including derivatives and coated products thereof, for in vitro cell attachment and culture and/or for use under the limitations of a For Research Use Only label, where the use is based upon the cellular receptor binding activity of the RGD or IKVAV amino acid sequence, including uses for: (i) screening of drugs and other bioactive materials; (ii) quality control and other analytical applications in research and/or development; and (iii) quality control and other analytical applications in the manufacture of other products. ** Material is confidential and has been omitted and filed seperately with the Securities and Exchange Commission. 19 Exhibit 3.2(b-c) ** ** Material is confidential and has been omitted and filed seperately with the Securities and Exchange Commission. 20 Exhibit 3.3(a) [**] ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 21 [**] ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. 22 Exhibit 3.3(a) [**] ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission.
EX-10.36 3 0003.txt FORM OF WARRANT TO PURCHASE COMMON STOCK Exhibit 10.36 WARRANT TO PURCHASE SHARES OF COMMON STOCK OF PROTEIN POLYMER TECHNOLOGIES, INC. THE WARRANTS REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND NEITHER THESE WARRANTS NOR ANY INTEREST THEREIN MAY BE TRANSFERRED, HYPOTHECATED OR OTHERWISE DISPOSED OF WITHOUT REGISTRATION UNDER THAT ACT OR AN OPINION OF COUNSEL ACCEPTABLE TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED. No. 00-GCOR-1 Warrant to Purchase Shares of December 21, 2000 Common Stock, $.01 Par Value WARRANT TO PURCHASE COMMON STOCK of PROTEIN POLYMER TECHNOLOGIES, INC., a Delaware corporation Void after the date set forth in the first paragraph hereof This certifies that, for value received, Genencor International Inc., or registered assigns ("Holder") is entitled, subject to the terms set forth ------ below, to purchase from Protein Polymer Technologies, Inc., a Delaware corporation (the "Company"), the number of shares of Common Stock, $.01 par ------- value, of the Company (such class of stock being referred to herein as "Common ------ Stock") equal to five hundred thousand dollars ($500,000) divided by the - ----- Purchase Price (as defined below), as constituted on December 21, 2000 (the "Issue Date"), upon surrender of this Warrant, at the principal office of the Company referred to below, with the subscription form attached hereto duly executed, and simultaneous payment therefor in the consideration specified in Section 1 hereof, **. The shares of Common Stock issued or issuable upon exercise of this Warrant are sometimes referred to as the "Warrant Shares." -------------- ** Material is confidential and has been omitted and filed separately with the Securities and Exchange Commission. The term "Warrants" as used herein shall include this Warrant and any warrants -------- delivered in substitution or exchange therefor as provided herein. 1. Exercise. This Warrant may be exercised at any time or from time to -------- time, on any business day, for all or part of the full number of Warrant Shares during the period of time called for hereby, by surrendering it at the principal office of the Company, 10655 Sorrento Valley Road, First Floor, San Diego, California 92121, with the subscription form duly executed, together with payment for the Warrant Shares payable in cash, by check for same day funds and/or by delivery and cancellation of promissory notes evidencing indebtedness of the Company. No other form of consideration shall be acceptable for the exercise of this Warrant. A Warrant shall be deemed to have been exercised immediately prior to the close of business on the date of its surrender for exercise as provided above, and the person entitled to receive the shares of Common Stock issuable upon such exercise shall be treated for all purposes as the holder of such shares of record as of the close of business on such date. As soon as practicable on or after such date, and in any event within 10 days thereof, the Company shall issue and deliver to the person or persons entitled to receive the same a certificate or certificates for the number of shares of Common Stock issuable upon such exercise. Upon any partial exercise, the Company will issue and deliver to Holder a new Warrant or Warrants with respect to the shares of Common Stock not so transferred. No fractional shares of Common Stock shall be issued upon exercise of a Warrant. In lieu of any fractional share to which Holder would be entitled upon exercise, the Company shall pay cash equal to the product of such fraction multiplied by the Purchase Price. 2. Payment of Taxes. All shares of Common Stock issued upon the exercise ---------------- of a Warrant shall be duly authorized, validly issued and outstanding, fully paid and non-assessable. Holder shall pay all taxes and other governmental charges that may be imposed in respect of the issue or delivery thereof and any tax or other charge imposed in connection with any transfer involved in the issue of any certificate for shares of Common Stock in any name other than that of the registered Holder of the Warrant surrendered in connection with the purchase of such shares, and in such case the Company shall not be required to issue or deliver any stock certificate until such tax or other charge has been paid or it has been established to the Company's satisfaction that no tax or other charge is due. 3. Transfer and Exchange. This Warrant and all rights hereunder are --------------------- transferable, in whole but not in part, only with the prior approval of the Company, which approval shall not be unreasonably withheld. If such a proposed transfer is so approved, this Warrant is transferable on the books of the Company maintained for such purpose at its principal office referred to above by Holder in person or by duly authorized attorney, upon surrender of this Warrant properly endorsed and upon payment of any necessary transfer tax or other governmental charge imposed upon such transfer. Each taker and holder of this Warrant, by taking or holding the same, consents and agrees that this Warrant, when endorsed in blank, shall be deemed negotiable and that when this Warrant shall have been so endorsed, the Holder hereof may be treated by the Company and all other persons dealing with this Warrant as the absolute owner hereof for any purpose and as the person entitled to exercise the rights represented hereby or to the transfer hereof on 2 the books of the Company, any notice to the contrary notwithstanding; but until such transfer on such books, the Company may treat the registered Holder hereof as the owner for all purposes. 4. Certain Adjustments. ------------------- 4.1 Adjustment for Reorganization, Consolidation, Merger. In case of ---------------------------------------------------- any reorganization of the Company (or any other corporation, the stock or other securities of which are at the time receivable on the exercise of this Warrant) after the Issue Date, or in case, after the Issue Date, the Company (or any such other corporation) shall consolidate with or merge into another corporation (other than the merger of a wholly owned subsidiary into the Company) or convey all or substantially all its assets to another corporation, then and in each such case Holder, upon the exercise hereof as provided in Section 1 at any time after the consummation of such reorganization, consolidation, merger or conveyance, shall be entitled to receive, in lieu of the stock receivable upon the exercise of this Warrant prior to such consummation, the stock or other securities or property to which such Holder would have been entitled upon such consummation if such Holder had exercised this Warrant immediately prior thereto. 4.2 Adjustments for Dividends in Common Stock. If the Company at any ----------------------------------------- time or from time to time after the Issue Date makes, or fixes a record date for the determination of holders of Common Stock entitled to receive, a dividend payable in additional shares of Common Stock, then and in each such event the Purchase Price then in effect shall be decreased as of the time of such issuance or, in the event such record date is fixed, as of the close of business on such record date, by multiplying the Purchase Price then in effect by a fraction (1) the numerator of which is the total number of shares of Common Stock issued and outstanding immediately prior to the time of such issuance or the close of business on such record date, and (2) the denominator of which shall be the total number of shares of Common Stock issued and outstanding immediately prior to the time of such issuance or the close of business on such record date plus the number of shares of Common Stock issuable in payment of such dividend; provided, however, that if such record date is fixed and such dividend is not fully paid on the date fixed therefor, the Purchase Price shall be recomputed accordingly as of the close of business on such record date and thereafter the Purchase Price shall be adjusted pursuant to this Section 4.2 as of the time of actual payment of such dividends. 4.3 Stock Split and Reverse Stock Split. If the Company at any time ----------------------------------- or from time to time after the Issue Date effects a subdivision of the outstanding Common Stock, the Purchase Price then in effect immediately before that subdivision shall be proportionately decreased and the number of shares of Common Stock theretofore receivable upon the exercise of this Warrant shall be proportionately increased. If the Company at any time or from time to time after the Issue Date combines the outstanding shares of Common Stock into a smaller number of shares, the Purchase Price then in effect immediately before that combination shall be proportionately increased and the number of shares of Common Stock theretofore receivable upon the exercise of this Warrant shall be proportionately decreased. Each adjustment under this 3 Section 4.3 shall become effective at the close of business on the date the subdivision or combination becomes effective. 4.4 Accountants' Certificate as to Adjustment. In each case of an ----------------------------------------- adjustment in the shares of Common Stock receivable on the exercise of the Warrants, the Company at its expense shall cause independent public accountants of recognized standing selected by the Company (who may be the independent public accountants then auditing the books of the Company) to compute such adjustment in accordance with the terms of the Warrants and prepare a certificate setting forth such adjustment and showing the facts upon which such adjustment is based. The Company will forthwith mail a copy of each such certificate to each holder of a Warrant at the time outstanding. 5. Loss or Mutilation. Upon receipt by the Company of evidence satisfactory ------------------ to it (in the exercise of reasonable discretion) of the ownership of and the loss, theft, destruction or mutilation of any Warrant and (in the case of loss, theft or destruction) of indemnity satisfactory to it (in the exercise of reasonable discretion), and (in the case of mutilation) upon surrender and cancellation thereof, the Company will execute and deliver in lieu thereof a new Warrant of like tenor. 6. Reservation of Common Stock. The Company shall at all times reserve and --------------------------- keep available out of its authorized but unissued shares of Common Stock, solely for the purpose of effecting the exercise of the Warrant, such number of its shares of Common Stock as shall from time to time be sufficient to effect exercise of the Warrant; and if at any time the number of authorized but unissued shares of Common Stock shall not be sufficient to effect such exercise, the Company will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purpose. 7. Notices of Record Date. In the event of (i) any taking by the Company of ---------------------- a record of the holders of any class of securities for the purpose of determining the holders thereof who are entitled to receive any dividend or other distribution, or (ii) any capital reorganization of the Company, any reclassification or recapitalization of the capital stock of the Company, any merger or consolidation of the Company with or into any other corporation (other than a merger of a wholly owned subsidiary into the Company), or any transfer of all or substantially all of the assets of the Company to any other person or any voluntary or involuntary dissolution, liquidation or winding up of the Company, the Company shall mail to the Holder at least thirty (30) days prior to the record date specified therein, a notice specifying (1) the date on which any such record is to be taken for the purpose of such dividend or distribution and a description of such dividend or distribution, (2) the date on which any such reorganization, reclassification, transfer, consolidation, merger, dissolution, liquidation or winding up is expected to become effective, and (3) the date, if any, that is to be fixed, as to when the holders of record of Common Stock (or other securities) shall be entitled to exchange their shares of Common Stock (or other securities) for securities or other property deliverable upon such reorganization, reclassification, transfer, consolidation, merger, dissolution, liquidation or winding up. 4 8. Investment Representation and Restriction on Transfer. ----------------------------------------------------- 8.1 Securities Law Requirements. --------------------------- (a) By its acceptance of this Warrant, Holder hereby represents and warrants to the Company that this Warrant and the Warrant Shares will be acquired for investment for its own account, not as a nominee or agent, and not with a view to the sale or distribution of any part thereof, and that it has no present intention of selling, granting participations in or otherwise distributing the same. By acceptance of this Warrant, Holder further represents and warrants that it does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participations to any person, with respect to this Warrant or the Warrant Shares. (b) By its acceptance of this Warrant, Holder understands that this Warrant is not, and the Warrant Shares will not be, registered under the Securities Act of 1933, as amended (the "Act"), on the basis that the issuance --- of this Warrant and the Warrant Shares are exempt from registration under the Act pursuant to Section 4(2) thereof, and that the Company's reliance on such exemption is predicated on Holder's representations and warranties set forth herein. (c) By its acceptance of this Warrant, Holder understands that the Warrant and the Warrant Shares may not be sold, transferred, or otherwise disposed of without registration under the Act, or an exemption therefrom, and that in the absence of an effective registration statement covering the Warrant and the Warrant Shares or an available exemption from registration under the Act, the Warrant and the Warrant Shares must be held indefinitely. In particular, Holder is aware that the Warrant and the Warrant Shares may not be sold pursuant to Rule 144 promulgated under the Act unless all of the conditions of Rule 144 are satisfied. Among the conditions for use of Rule 144 are the availability of current information about the Company to the public, prescribed holding periods which will commence only upon Holder's payment for the securities being sold, manner of sale restrictions, volume limitations and certain other restrictions. By its acceptance of this Warrant, Holder represents and warrants that, in the absence of an effective registration statement covering the Warrant or the Warrant Shares, it will sell, transfer or otherwise dispose of the Warrant and the Warrant Shares only in a manner consistent with its representations and warranties set forth herein and then only in accordance with the provisions of Section 8.1(d). (d) By its acceptance of this Warrant, Holder agrees that in no event will it transfer or dispose of any of the Warrants or the Warrant Shares other than pursuant to an effective registration statement under the Act, unless and until (i) Holder shall have notified the Company of the proposed disposition and shall have furnished the Company with a statement of the circumstances surrounding the disposition, and (ii) if reasonably requested by the Company, at the expense of the Holder or transferee, it shall have furnished to the Company an opinion of counsel, reasonably satisfactory to the Company, to the effect that (A) such transfer may be made without registration under the Act and (B) such transfer or disposition will not cause the termination or the non- applicability of any exemption to the registration and prospectus delivery requirements of 5 the Act or to the qualification or registration requirements of the securities laws of any other jurisdiction on which the Company relied in issuing the Warrant or the Warrant Shares. 8.2 Legends; Stop Transfer. ---------------------- (a) All certificates evidencing the Warrant Shares shall bear a legend in substantially the following form: The securities represented by this certificate have not been registered under the Securities Act of 1933. These securities have been acquired for investment and not with a view to distribution and may not be offered for sale, sold, pledged or otherwise transferred in the absence of an effective registration statement for such securities under the Securities Act of 1933 or an opinion of counsel reasonably satisfactory in form and content to the issuer that such registration is not required under such Act. (b) The certificates evidencing the Warrant Shares shall also bear any legend required by any applicable state securities law. (c) In addition, the Company shall make, or cause its transfer agent to make, a notation regarding the transfer restrictions of the Warrant and the Warrant Shares in its stock books, and the Warrant and the Warrant Shares shall be transferred on the books of the Company only if transferred or sold pursuant to an effective registration statement under the Act covering the same or pursuant to and in compliance with the provisions of Section 8.1(d). 9. Piggyback Registration Rights. ----------------------------- 9.1 Registration Rights. If at any time during the "Registration ------------------- Period" (as hereinafter defined) the Company proposes to file a registration statement under the Securities Act of 1933, as amended (the "Securities Act") relating to a proposed sale to the public of its Common Stock, whether or not for its own account and whether or not pursuant to the exercise of any demand registration rights held by other security holders (but excluding registrations relating solely to employee stock option or purchase plans or to transactions employing Forms S-4 or S-8, a registration in which the only stock being registered is Common Stock issuable upon conversion of securities which are also being registered, and any registration on any form which does not include substantially the same information as would be required to be included in a registration statement covering the sale of the Warrant Shares), the Company will each such time give prompt written notice to the Holder of its intention to do so and of the Holder's rights under this Section 9, at least ten (10) days prior to the anticipated filing date of the registration statement. Such notice shall offer Holder the opportunity to include in such registration statement such number of Warrant Shares as Holder may request. For purposes hereof, the term "Registration Period" shall mean the period commencing on the date hereof and ending 6 when all the Warrant Shares may be sold within any three (3) month period pursuant to Rule 144 of the Securities Act. 9.2 Registration Procedures. Upon the written request of Holder made ----------------------- within ten (10) days after receipt of the Company's notice (which request shall specify the number of Warrant Shares intended to be disposed of by Holder), the Company will use its best efforts to effect the registration under the Securities Act and the qualification under any applicable state securities or Blue Sky laws of all Warrant Shares which the Company has been so requested to register by Holder; provided that: (i) if the registration involves an underwritten public offering, Holder requesting that Warrant Shares be included in the Company's registration statement must, upon request by the underwriter(s), sell their Warrant Shares to such underwriter(s) selected by the Company or the security holders for whose account the registration is being effected on the same terms and conditions as apply to the Company or the selling security holders on whose account the registration is being effected; and (ii) if a registration involves an underwritten public offering, Holder requesting to be included in such registration may elect in writing at least ten (10) days prior to the effective date of the registration statement filed in connection with such registration, not to register any Warrant Shares thereunder. The Company shall have the right to terminate or withdraw any registration initiated by it prior to the effectiveness of the registration statement whether or not any Holder has elected to include any Warrant Shares in the registration. 9.3 Priority on Registration. Further, and notwithstanding the ------------------------ foregoing, if a registration involves an underwritten offering and the managing underwriter advises the Company in writing that, in its opinion, the total number of shares to be included in such registration, including the Warrant Shares requested to be included pursuant to this Section 9, exceeds the maximum number of shares of Common Stock specified by the managing underwriter that may be distributed without adversely affecting the price, timing or distribution of such shares of Common Stock, then the Company, subject to any pre-existing agreements giving any other security holders priority, shall include in such registration only such maximum number of shares which, in the reasonable opinion of such underwriter or underwriters can be sold in the following order of priority: (i) first, all of the shares of Common Stock that the Company proposes to sell for its own account or, in the case of a demand registration effected for the account of other security holders, all of the shares of Common Stock that such security holders propose to sell for their own account, and (ii) second, the Warrant Shares and all other shares requested to be included by other holders of Common Stock (except those exercising a demand right) and, in the case of a demand registration, all shares to be included for the account of the Company. To the extent that shares of Common Stock to be included in the registration must be allocated among Holder and/or other security holders and/or the Company, such shares shall be allocated pro rata among Holder and all other holders of Common Stock who requested inclusion in the registration (except those holders, if any, exercising a demand right) and, in the case of a demand registration, the Company, based upon the number of Warrant Shares or other securities that such holders and/or the Company shall have requested be included in the registration. 7 10. Notices. All notices and other communications from the Company to the ------- Holder of this Warrant shall be mailed by first-class registered or certified mail, postage prepaid, to the address furnished to the Company by Holder. 11. Change; Waiver. Neither this Warrant nor any term hereof may be -------------- changed, waived, discharged or terminated orally, but only by an instrument in writing signed by the party against which enforcement of the change, waiver, discharge or termination is sought. 12. Headings. The headings in this Warrant are for purposes of convenience -------- in reference only, and shall not be deemed to constitute a part hereof. 13. Governing Law. This Warrant is delivered in California and shall be ------------- construed and enforced in accordance with and governed by the internal laws, and not the law of conflicts, of such State; provided however, that to the extent that an issue of determination is one of corporation law, then the Delaware General Corporation Law shall govern. PROTEIN POLYMER TECHNOLOGIES, INC., a Delaware corporation By______________________________________ J. Thomas Parmeter, President 8 SUBSCRIPTION FORM (To be executed only upon exercise of Warrant) The undersigned, registered owner of this Warrant, irrevocably exercises this Warrant and purchases ____________ of the number of shares of Common Stock, $.01 par value, of PROTEIN POLYMER TECHNOLOGIES, INC., a Delaware corporation, purchasable with this Warrant, and herewith makes payment therefor, all at the price and on the terms and conditions specified in this Warrant. DATED:______________ ______________________________ (Signature of Registered Owner) ______________________________ (Street Address) ______________________________ (City) (State) (Zip) 9 FORM OF ASSIGNMENT ------------------ FOR VALUE RECEIVED the undersigned, registered owner of this Warrant, hereby sells, assigns and transfers unto the Assignee named below all of the rights of the undersigned under the within Warrant, with respect to the number of shares of Common Stock, $.01 par value, set forth below: Name of Assignee Address No. of Shares - ---------------- ------- ------------- and does hereby irrevocably constitute and appoint _________________________ _________________________________________________ Attorney to make such transfer on the books of PROTEIN POLYMER TECHNOLOGIES, INC., a Delaware corporation, maintained for the purpose, with full power of substitution in the premises. DATED: ___________________ ________________________ (Signature) ________________________ (Witness) 10 EX-23.1 4 0004.txt CONSENT OF E & Y Exhibit 23.1 CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS We consent to the incorporation by reference in the Registration Statements on Forms S-3 (Nos. 333-19695, 333-62761, 333-45759) and Forms S-8 (Nos. 33-61704, 33-61708, 33-68046), of our report dated February 8, 2001 with respect to the financial statements of Protein Polymer Technologies, Inc. included in the Annual Report (Form 10-KSB) for the year ended December 31, 2000. ERNST & YOUNG LLP San Diego, California February 21, 2001
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