SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31,2002 Commission File No. 1-11083
BOSTON SCIENTIFIC CORPORATION
(Exact Name Of Company As Specified In Its Charter)
DELAWARE 04-2695240 (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) |
(508) 650-8000
(Company's Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
COMMON STOCK, $.01 PAR VALUE PER SHARE
(Title Of Class)
Securities registered pursuant to Section 12(g) of the Act:
NONE
Indicate by check mark whether the Company (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Company was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes: X No ______
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Company's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to the Form 10-K. [ ]
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act).
Yes: X No ______
The aggregate market value of Common Stock held by non-affiliates (persons other than directors, executive officers, and related family entities) of the Company was approximately $9.1 billion based on the closing price of the Common Stock on June 28, 2002.
The number of shares outstanding of the Company's Common Stock as of March 21, 2003, was 409,947,858.
DOCUMENTS INCORPORATED BY REFERENCE
The Company's 2002 Consolidated Financial Statements for the year ended December 31, 2002 which are filed with the Securities and Exchange Commission (the "Commission") as an exhibit hereto and the Company's 2003 Proxy Statement to be filed with the Securities and Exchange Commission on or about April 4, 2003 are incorporated by reference into Parts I, II and III hereof.
PART I
ITEM 1. BUSINESS
THE COMPANY
Boston Scientific Corporation (the "Company") is a worldwide developer, manufacturer and marketer of less-invasive medical devices. The Company's products are used in a broad range of interventional medical specialties, including interventional cardiology, peripheral intervention, neurovascular, electrophysiology, vascular surgery, gastroenterology, gynecology, oncology and urology. The Company's products are generally inserted into the human body through natural openings or small incisions in the skin and can be guided to most areas of the anatomy to diagnose and treat a wide range of medical problems. These products provide effective alternatives to traditional surgery by reducing risk, trauma, cost, procedure time and the need for aftercare.
The Company's history began in the late 1960s when the Company's co-founder, John Abele, acquired an equity interest in Medi-tech, Inc., a development company. Medi-tech's initial products, a family of steerable catheters, were introduced in 1969. They were used in some of the first less-invasive procedures performed, and versions of these catheters are still being sold today. In 1979, John Abele joined with Pete Nicholas to form the Company, which indirectly acquired Medi-tech, Inc. This acquisition began a period of active, focused marketing, new product development and organizational growth. Since then, the Company's net sales have increased substantially, growing from $1.8 million in 1979 to more than $2.9 billion in 2002.
The Company's growth has been fueled in part by strategic acquisitions and alliances designed to improve the ability of the Company to take advantage of growth opportunities in less-invasive medicine. These acquisitions have helped the Company to achieve a strategic mass which allows it to offer one of the broadest product lines in the world for use in less-invasive procedures. The Company's strategic mass has also enabled it to compete more effectively in, and better absorb the pressures of, the current health care environment of cost containment, managed care, large buying groups and hospital consolidations.
AVAILABLE INFORMATION. Copies of the Company's annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available free of charge through the Company's website (www.bostonscientific.com) as soon as reasonably practicable after the Company electronically files the material with or furnishes it to the Securities and Exchange Commission ("SEC"). The Company's proxy statement and Code of Conduct (and amendments thereto), which applies to all employees and officers of the Company, including the Chief Executive Officer and Chief Financial Officer, are also available on the Company's web site. Printed copies of these materials are also available free of charge to shareholders that request them in writing from Investor Relations. Information on the Company's website or connected thereto is not incorporated by reference into this Form 10-K.
CORONARY STENTS AND THE DRUG ELUTING STENT OPPORTUNITY
During 2002, the Company reestablished its position in the coronary stent market with the highly competitive Express(TM) coronary stent system. The Company also marketed its next-generation coronary angioplasty balloon, the Maverick(R) balloon dilatation catheter, now the market leader. The Company then combined the original Express stent with the advanced Maverick balloon catheter technology to create the Express(2) stent system, which was launched in Europe and the United States during the year. As a result, at the end of 2002 the Company regained leadership in the cardiovascular and peripheral vascular catheter labs.
The Company believes that the combination of drugs and coronary stents offers the possibility of a more lasting solution for coronary artery disease, particularly the processes that lead to instent restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. Drug-eluting stents are expected to reduce the need for repeat procedures - or more expensive surgical procedures - and to significantly reduce health care costs, as well as overall patient risk, trauma, procedure time and the need for post-procedural care.
Since 1997, the Company has been developing a proprietary polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis. The Company's TAXUS(TM) paclitaxel-eluting coronary stent system is built on the Express stent technology. The conformability of the stent within a diseased coronary artery benefits the Company's polymer-based drug eluting technology and contributes to the clinical differentiation of the TAXUS drug-eluting stent platform from others.
The Company has invested in the TAXUS clinical program, a series of studies designed to collect data on the TAXUS paclitaxel-eluting stent. Prior studies have demonstrated promising results by dramatically reducing restenosis. The proprietary polymer on the stent allows for controlled delivery of paclitaxel. Paclitaxel is a multi-functional microtubular inhibitor that controls platelets, smooth muscle cells and white blood cells, all of which are believed to contribute to restenosis.
An overview of the Company's TAXUS clinical program, initiated in 1997, is presented below.
------------------------------------------------------------------------------------------------------------------------------------ Overview Findings ------------------------------------------------------------------------------------------------------------------------------------ TAXUS I - A feasibility study designed to assess the safety of a - No stent thromboses were reported at six months. slow release formulation, paclitaxel-eluting coronary stent - Thirty day MACE (Major Adverse Cardiac Events for the treatment of de novo coronary lesions. including death, myocardial infarction and - A 61-patient, randomized, double blind, revascularization) was zero percent. multi-center safety trial. - This study is currently approaching 2 year - Conducted at three centers in Germany. follow-up. ------------------------------------------------------------------------------------------------------------------------------------ TAXUS II - A 536-patient, 15 country, randomized, double - The slow release formulation cohort reported an blind, controlled study of paclitaxeleluting coronary in-stent binary restenosis rate of 2.3 percent and stents. an in-segment binary restenosis rate of 5.5 percent - Two sequential cohorts of patients with standard at six months. risk, de novo coronary artery lesions. - The moderate release formulation cohort reported an - Slow release and moderate release formulations in-stent binary restenosis rate of 4.7 percent and studied in separate cohorts. an in-segment binary restenosis rate of 8.6 percent at six months. - This study has recently completed one-year follow-up. ------------------------------------------------------------------------------------------------------------------------------------ TAXUS III - A 29-patient, single-arm registry examining the - At six-month follow up, the trial confirmed feasibility of implanting up to two paclitaxel-eluting safety and reported no stent thromboses. stents for the treatment of in-stent restenosis. - An overall binary restenosis rate, including distal - Patients with complex vascular disease having and proximal edges, of 16 percent, and an in-stent recurrent occlusion in a stent, who tend to have an restenosis rate of 4 percent was reported at increased probability of restenosis. six-month follow up. ------------------------------------------------------------------------------------------------------------------------------------ |
------------------------------------------------------------------------------------------------------------------------------------ - Overview - Findings ------------------------------------------------------------------------------------------------------------------------------------ TAXUS IV - A pivotal trial studying 1,326 patients designed to - Thirty-day safety data showed an overall favorable collect data to support regulatory filings for U.S. MACE rate of three percent. product commercialization. - The trial has a primary endpoint based on nine-month - A prospective, randomized, double-blind study target vessel revascularization. assessing the safety and efficacy of a slow release - This study is currently approaching nine-month formulation for the treatment of de novo coronary lesions. follow-up. - The TAXUS IV trial uses the Company's internally developed Express(TM) stent. ------------------------------------------------------------------------------------------------------------------------------------ TAXUS V - This multi-center trial will study a higher risk - This trial, which began in March 2003, has a primary patient population than TAXUS IV, including patients with endpoint based on nine-month target vessel smaller vessels and longer lesions. revascularization. - The trial includes the use of multiple stents. - This study is currently enrolling patients. - Received conditional approval from the FDA. - This trial uses the Company's internally developed Express stent. ------------------------------------------------------------------------------------------------------------------------------------ TAXUS VI - An International multi-center trail studying 448 patients - This trial has a primary endpoint based on with complex coronary artery disease at 44 sites nine-month target vessel revascularization. designed to establish the safety and efficacy of a - This study is currently approaching 30-day moderate release formulation in the treatment of longer follow-up. lesions of 18 to 40 mm in length. - The trial includes the use of multiple stents. - This trial uses the Company's internally developed Express stent. ------------------------------------------------------------------------------------------------------------------------------------ |
The Company has also initiated a transitional registry program (WISDOM) as part of a limited international commercial launch. This multi-center, prospective, observational registry is collecting and analyzing "real world" data on the performance of the TAXUS paclitaxel-eluting stent system for the treatment of patients with coronary artery disease. A registry program enlists large numbers of clinicians to document the performance of a specific therapy for a particular disease or condition. To date, this registry has enrolled more than 400 patients.
In March 2003, the Company began a post-approval European registry (Milestone
II) with the TAXUS coronary stent system. This registry is targeting 100 sites
and plans to enroll 2,000 patients to study real-world usage patterns.
To support commercialization of the TAXUS coronary stent system in the United States, the Company submitted the first two modules of its application for Pre-Market Approval to the Food & Drug Administration ("FDA") during February and March 2003. A total of five modules are expected to be submitted between February and June 2003. The last module will include data from the TAXUS IV clinical trial. In March 2003, the FDA notified the Company that it had granted the TAXUS coronary stent system "expedited review" status, which means that the application is designated to receive priority review before other pending applications. The Company expects to launch the TAXUS paclitaxel-eluting coronary stent in the United States in late 2003 and in Japan in early 2005, pending regulatory approvals.
The worldwide coronary stent market is dynamic and highly competitive with significant market share volatility. The introduction of drug-eluting stents is likely to have a significant impact on the market size for coronary stents and on the distribution of market share across the industry. The Company believes drug-eluting stent technology represents one of the largest market opportunities in the history of the medical device industry. It is estimated that the annual worldwide market for coronary stents, including drug-eluting stents, may grow to $5 billion by 2005, compared to approximately $2.2 billion today. Although the Company believes it is positioned to be one of only two early entrants in this market, uncertainties exist about the rate of development and size of this new market. The Company's success with drug-eluting stents could be adversely affected by more gradual physician adoption rates, changes in reimbursement policies, delayed or limited regulatory approvals, unexpected variations in clinical results, the earlier availability of a competitor's technology, third party intellectual property, the outcome of litigation and the availability of inventory to meet customer demand. A more gradual physician adoption rate may limit the number of procedures in which the technology may be used and the price at which institutions may be willing to purchase the technology. Together, these and other factors contribute to the uncertainty surrounding the evolution of the drug-eluting stent market and the Company's position in it.
STRATEGIC ACQUISITIONS AND ALLIANCES
The Company has entered into a series of strategic acquisitions and alliances, each intended to further expand the Company's ability to offer its customers effective, quality medical devices that satisfy their interventional needs. Over the last year, the Company completed the following representation of acquisitions and alliances, adding new or complementary technologies to its already diverse portfolio.
Acquisitions -------------------------------------------------------------------------------- BEI Medical Systems Acquisition of Hydro Company, Inc. ThermAblator(R) (HTA(R)) System, a less-invasive technology for global endometrial ablation designed to treat excessive uterine bleeding due to benign causes. Expands the Company's product offerings in the area of women's health. -------------------------------------------------------------------------------- Enteric Medical Acquisition that adds Enteryx(R)a Technologies, Inc patented liquid polymer for the treatment of gastroesophageal reflux disease (GERD). -------------------------------------------------------------------------------- Smart Therapeutics, Inc. Acquisition that broadens the Company's neurovascular portfolio with the Neuroform(TM) Microdelivery stent system for the treatment of wide neck intracranial aneurysms. -------------------------------------------------------------------------------- Alliances |
implantable therapies to manage chronic pain and other disorders of the central nervous system. -------------------------------------------------------------------------------- Aspect Medical Systems, Inc. Strategic alliance that focuses on the development and distribution of brain monitoring technology specifically designed to enhance the safety, efficiency and delivery of sedation to patients undergoing less-invasive medical procedures. -------------------------------------------------------------------------------- Celsion Corporation Distribution rights to Celsion's Microfocus BPH 800 Microwave Urethroplasty(TM) system for the treatment of benign prostatic hyperplasia (BPH). -------------------------------------------------------------------------------- Therus Corporation Equity investment and exclusive distribution rights which strengthens and expands the Company's vascular sealing device portfolio. -------------------------------------------------------------------------------- TriVascular, Inc. Exclusive international distribution rights for percuataneous aortic stent graft technology designed to improve the outcome of procedures to treat abdominal aortic aneurysm (AAA). -------------------------------------------------------------------------------- |
As the health care environment continues to undergo rapid change, the Company expects that it will continue to focus on strategic initiatives and make additional investments in its existing relationships.
BUSINESS STRATEGY
The Company's mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare. The Company's approach to innovation combines internally developed products and technologies with those obtained externally through strategic acquisitions and alliances.
Key elements of the Company's overall business strategy are as follows:
Innovation. The Company is committed to driving growth through harnessing technological innovation both in the near and long term. The Company's approach to enhancing innovation includes a mixture of tactical and strategic initiatives that are designed to offer sustainable growth. Combining internally developed products and technologies with those obtained through acquisition and alliances allows the Company to focus on and deliver new products currently in its pipeline as well as strengthen the Company's technology portfolio and development processes and tools.
Product Diversity. The Company offers products in numerous product categories which are used by physicians throughout the world in a broad range of diagnostic and therapeutic procedures. The breadth and diversity of the Company's product lines permit medical specialists to satisfy many of their less-invasive medical device requirements from a single source.
Clinical Excellence. The Company's commitment to innovation is further demonstrated by its rapidly expanding clinical capabilities. The Company's clinical teams are organized by therapeutic specialty to better align with research and development, marketing and sales teams. During 2002, the clinical organization planned, initiated and conducted a series of focused clinical trials that support regulatory requirements and demonstrate the safe and effective clinical performance of products and technologies.
Operational Excellence. The Company is focused on continuously improving its supply chain effectiveness, strengthening its manufacturing processes and optimizing its plant network in order to increase operational efficiencies within the organization and generate savings. By centralizing its operations at the corporate level and shifting global manufacturing along product lines, the Company is able to leverage its existing resources and concentrate on new product development and launch.
Focused Marketing. Each of the Company's business groups maintain dedicated sales forces and marketing teams focusing on physicians who specialize in the diagnosis and treatment of different medical conditions and offer products to satisfy their needs. The Company believes that this focused disease state management enables it to develop highly knowledgeable and dedicated sales representatives and to foster close professional relationships with physicians.
Active Participation In The Medical Community. The Company believes that it has excellent working relationships with physicians and others in the medical industry which enable it to gain a detailed understanding of new therapeutic and diagnostic alternatives, and to respond quickly to the changing needs of physicians and patients. Active participation in the medical community contributes to physician understanding and adoption of less-invasive techniques and the expansion of these techniques into new therapeutic and diagnostic areas.
Corporate Culture. Management believes that success and leadership evolve from a motivating corporate culture which rewards achievement, respects and values individual employees and customers, and has a long-term focus on quality, technology, integrity and service. The Company believes that its success is attributable in large part to the high caliber of its employees and the Company's commitment to respecting the values on which its success has been based.
PRODUCTS
The Company's products are offered by two dedicated business groups - Cardiovascular and Endosurgery. During 2002, the Cardiovascular organization focused on products and technologies for use in interventional cardiology, interventional radiology, electrophysiology, peripheral vascular intervention and neurovascular procedures. The Endosurgery organization focused on products and technologies for use in oncology, vascular surgery, endoscopy, urology and gynecology procedures. During 2002, approximately 68% of the Company's net sales were derived from the Company's Cardiovascular business and approximately 32% from its Endosurgery business.
The Company's principal Cardiovascular and Endosurgery products are offered in the following medical areas:
CARDIOVASCULAR
Coronary Revascularization. The Company markets a broad line of products used to treat patients with atherosclerosis. Atherosclerosis, a coronary vessel disease and a principal cause of heart attacks, is characterized by a thickening of the walls of the arteries and a narrowing of arterial lumens (openings) caused by the progressive development of deposits of plaque. The majority of the Company's products in this market are used in percutaneous transluminal coronary angioplasty ("PTCA") and percutaneous transluminal coronary rotational atherectomy and include PTCA balloon catheters, the Rotablator(R) and Rotalink(R) rotational atherectomy systems, guide wires, guide catheters and diagnostic catheters. In 2002, the Company's Maverick(R) balloon dilatation catheter, offered for commercial sale around the world, became the market leading angioplasty catheter. The Maverick balloon catheter features TrakTip(TM), which creates a flexible kink-resistant taper. The TrakTip's low lesion entry profile is designed to enable excellent crossability and easy lesion engagement. In December 2002, the Company launched two new balloon catheters in the United States, the Maverick(2)(TM) Monorail(R) Coronary Balloon Dilatation Catheter and the Quantum(TM) Maverick(R) Coronary Balloon Dilatation Catheter.
The Company also offers the Cutting Balloon(TM) catheter, a balloon angioplasty device that combines features of conventional angioplasty with advanced microsurgical technology. During 2002, the Company launched the Cutting Balloon(TM) Monorail(R) Device and expects to launch the Cutting Balloon Ultra(2)(TM) Microsurgical Dilatation Catheter in the United States during 2003, pending regulatory approval.
Coronary Stents. The Company markets both balloon-expandable and self-expanding coronary stent systems. Coronary stents are tiny, mesh tubes used in the treatment of coronary artery disease and implanted in patients to prop open arteries and facilitate blood flow to the heart.
During 2002, the Company launched its Express(2)(TM) coronary stent system in the United States, Europe and other international markets and expects to launch the product in Japan later in 2003. The Express(2) coronary stent system, developed exclusively by the Company, features two of its most impressive technologies - the Express stent and the Maverick(R) balloon dilatation catheter. The Express stent is a laser-cut, balloon-expandable stent that features a unique design concept called Tandem Architecture(TM). The Tandem Architecture stent design integrates short, thin Micro(TM) elements designed for flexibility and conformability, with long, wide Macro(TM) elements designed to enhance radiopacity. The Express(2) stent system features a laser-bonded, flexible tip with a long, low profile designed for easier tracking.
Fluid Management. The Company markets a broad line of fluid delivery sets, pressure monitoring systems, custom kits and accessories that provide for the injection of contrast and saline or the withdrawal and disposal of bodily waste.
Electrophysiology. The Company's electrophysiology product offerings include catheters and systems for use in less-invasive procedures to diagnose and treat tachyarrhythmias (abnormally fast heart rhythms). The Company markets RF generators, mapping systems, intracardiac ultrasound and steerable ablation catheters, many of which incorporate proprietary steering, temperature monitoring and control technology, as well as a line of diagnostic catheters and associated accessories. The Company also offers the Chilli(R) cooled ablation catheter and Realtime Position Management(TM) system. These products are designed for ablating (neutralizing) the tissue in the heart that is responsible for starting or maintaining the tachyarrhythmia and for navigating EP catheters within the heart.
Peripheral Vascular Intervention. The Company sells various products designed to treat patients with peripheral vascular disease (disease which appears in blood vessels other than in the heart), including a broad line of medical devices used in percutaneous transluminal angioplasty and thrombolysis (the catheter-based delivery of clot dissolving agents directly to the site of a blood clot). Additionally, the Company's peripheral vascular product line includes balloon catheters, thrombectomy catheters, and stents (including the Wallstent(R) endoprosthesis).
Embolic Protection. One of the most promising areas in interventional medicine is embolic protection. Internationally, the Company offers the Filterwire EX(TM) device, which is designed to capture material dislodged into the bloodstream during cardiovascular interventions, potentially preventing a heart attack or stroke. The FilterWire EX device is available for use in coronary, saphenous vein graft, carotid and peripheral vessel applications in markets outside the United States. During the fourth quarter of 2002, the Company submitted an application to the FDA for 510(k) clearance to market the Filterwire EX device for saphenous vein graft application in the United States.
Caval Interruption Systems. The Company markets the Greenfield(R) vena cava filter system for use in patients who are at risk of developing a pulmonary embolism due to an existing medical condition or post-surgical complications. Once the filter is implanted, circulating emboli (blood clots) can be captured and held by the lattice design of the filter, allowing the clots to dissolve naturally before they can reach the pulmonary system. The Company expects to launch a new reduced profile vena cava filter, the Greenfield(R) RP Vena Cava Filter, later in 2003, pending regulatory approval.
Intraluminal Ultrasound Imaging. The Company markets a family of intraluminal catheter-directed ultrasound imaging catheters and systems for diagnostic use in blood vessels, heart chambers and coronary arteries, as well as certain nonvascular systems.
Neurovascular Interventions. The Company markets a line of micro-guidewires, micro-catheters, guiding catheters and embolics to treat diseases of the neurovascular system. The Company also markets the GDC(R) (Guglielmi Detachable Coil) system to treat and prevent the rupture of cerebral aneurysms that are otherwise either considered to be inoperable or high risk for surgery. Results from the International Subarachnoid Aneurysm Trial (ISAT) demonstrated that less-invasive endovascular treatment with detachable platinum coils, such as the Company's GDC(R) coil, produce better outcomes than neurosurgical clipping for patients suffering from ruptured brain aneurysms. During 2002, the Company completed its acquisition of Smart Therapeutics, Inc. ("Smart"), a company that has developed a stent system for treating "wide neck" aneurysms, which are among the most difficult to treat. The combination of Smart's stent and the Company's GDC coil may provide a less-invasive treatment alternative for patients whose only previous option may have been open surgery.
The Company's next generation Matrix(TM) Detachable Coil features a proprietary bioabsorbable polymer and leverages technology from the well known, clinically proven GDC(R) system. The Matrix Detachable Coil has received clearance from the FDA for endovascular treatment of cerebral aneurysms and was granted the CE Mark in Europe. This technology is being introduced into selected worldwide markets in conjunction with physician training programs.
ENDOSURGERY
Esophageal, Gastric And Duodenal (Small Intestine) Intervention. The Company markets a broad range of products to diagnose, treat and palliate a variety of gastrointestinal diseases and conditions, including those affecting the esophagus, stomach and colon. Common disease states include esophagitis, gastroesophageal reflux disease ("GERD"), portal hypertension, peptic ulcers and esophageal cancer. The Company's products in this area include disposable single and multiple biopsy forceps, balloon dilatation catheters and enteral feeding devices. The Company also markets a family of esophageal stents designed to offer improved dilatation force and greater resistance to tumor in-growth. During 2002, the Company completed its acquisition of Enteric Medical Technologies, Inc. ("EMT"), adding EMT's Enteryx(TM) liquid polymer technology, designed to treat symptoms associated with chronic GERD, to the Company's portfolio. Currently, the Enteryx product is under Pre-Market Approval (PMA) review at the FDA, making it the first less-invasive medical device treatment for GERD to undergo this stringent evaluation. In January 2003, the Gastroenterology and Urology Device Panel voted unanimously to recommend to the FDA the approval of the Enteryx product for the treatment of symptoms of GERD in patients who require and respond to pharmaceutical therapy.
Colorectal Intervention. The Company markets a line of hemostatic catheters, polypectomy snares, biopsy forceps, enteral stents and dilatation catheters for the diagnosis and treatment of polyps, inflammatory bowel disease, diverticulitis and colon cancer.
Pancreatico-Biliary Intervention. The Company sells a variety of products to diagnose, treat and palliate benign and malignant strictures of the pancreatico-biliary system (the gall bladder, common bile duct, hepatic duct, pancreatic duct and the pancreas) and to remove stones found in the common bile duct. The Company's products include diagnostic catheters used with contrast media, balloon dilatation catheters and sphincterotomes. The Company also markets self-expanding metal and temporary biliary stents for palliation and drainage of the common bile duct.
Pulmonary Intervention. The Company markets devices to diagnose, treat and palliate diseases of the pulmonary system. The major devices include pulmonary biopsy forceps, transbronchial aspiration needles, cytology brushes and tracheobronchial stents used to dilate strictures or for tumor management. Included in this product offering is the Ultraflex(TM) Tracheobronchial Stent System and the Wallstent(R) Tracheobronchial Endoprosthesis.
Urinary Tract Intervention and Bladder Disease. The Company sells a variety of products designed primarily to treat patients with urinary stone disease, including ureteral dilatation balloons used to dilate strictures or openings for scope access; stone baskets used to manipulate or remove the stone; intracorporeal shock wave lithotripsy devices and holmium laser systems used to disintegrate stones; ureteral stents implanted temporarily in the urinary tract to provide short-term or long-term drainage; and a wide variety of guidewires used to gain access to a specific site. The Company has also developed other devices to diagnose and treat bladder cancer and bladder obstruction.
Prostate Intervention. For the treatment of Benign Prostatic Hyperplasia ("BPH"), the Company currently markets electro-surgical resection devices designed to resect large diseased tissue sites and an automatic disposable needle biopsy system, designed to take rapid core prostate biopsies. In January 2003, the Company announced an alliance with Celsion Corporation to distribute Celsion's Microfocus BPH 800 Microwave Urethroplasty(TM) system for the treatment of BPH.
Urinary Incontinence. The Company markets a line of less-invasive devices and dermal sling materials to treat stress urinary incontinence, an affliction commonly treated with various surgical procedures. The Company's Precision Tack(R), Precision Twist(R) and Capio(R) devices and Vesica(R) systems offer less-invasive alternatives for treating incontinence.
Gynecology. In 2002, the Company expanded its product offerings in the area of women's health through the acquisition of BEI Medical Systems Company, Inc. BEI designs, manufactures and markets the Hydro ThermAblator(R) (HTA(R)) System, a less-invasive technology for the treatment of excessive uterine bleeding by ablating the lining of the uterus, the tissue responsible for menstrual bleeding.
Oncology Intervention. The Company markets a broad line of products designed to treat, diagnose and palliate various forms of cancer. Its current suite of products include a variety of microcatheters, embolic materials, coils and other products used to restrict blood supply to targeted organs of other areas of the body as well as biopsy devices. In addition, the Company also markets radiofrequency based therapeutic devices for the ablation of various forms of soft tissue lesions (tumors). In 2002, Contour(R) SE Microspheres, a novel spherical embolization product used to treat hypervascular tumors and arteriovenous malformations, was launched in the United States. The Contour(R) SE Microsphere product is designed to shrink and destroy hypervascular tumors and arteriovenous malformations by blocking the blood supply feeding them.
Central Venous Access. The Company offers a venous access line which includes valved and non-valved product offerings. The innovative PASV(R) valve technology is designed to reduce the incidence of occlusion and blood stream infection.
Surgical And Endovascular Grafts. The Company designs vascular grafts and endovascular stent grafts for the treatment of thoracic dissection, dialysis access, abdominal aortic aneurysms and peripheral vascular occlusive diseases, including the Exxcel(TM) vascular graft for peripheral indications and dialysis access and a line of Hemashield(R) grafts and fabrics for peripheral vascular and cardiovascular indications. Effective January 1, 2003, this product line was moved from the Endosurgery business group to the Cardiovascular business group.
MARKETING AND SALES
During 2002, the Company marketed and sold its products through six divisions. To best serve its customers, the sales and marketing organizations of these six divisions were aligned and centralized under two groups, Cardiovascular and Endosurgery. During 2002, Scimed, EP Technologies and the peripheral vascular business of Medi-tech operated within the Cardiovascular Group. The Target Therapeutics division remained a distinct marketing and sales organization within the Cardiovascular Group. The Medi-tech Surgery/Oncology, Microvasive Urology and Microvasive Endoscopy businesses operated within the Endosurgery Group.
In early 2003, Boston Scientific announced a master branding initiative. This initiative marks the Company's evolution from a collection of divisional identities into one, unified organization. The master brand will enable the Company to better focus efforts on strengthening the recognition of the Boston Scientific name and building equity in that name, as well as conveying the depth and breadth of the Company, growing the business, recruiting and retaining strong talent, and ultimately increasing shareholder value.
The Company's tag line: Delivering what's next.(TM)conveys the essence of Boston Scientific: a committed, forward-looking company executing on its promises and bringing the latest medical innovations to its customers and their patients.
Following the launch of the Company's branding initiative later in 2003, the Company will market its products through nine principal operating businesses, each focusing upon physicians who specialize in the diagnosis and treatment of different medical conditions and disease states. An overview of the Company's 2002 divisional and 2003 operating business structure is outlined below.
Cardiovascular Group
---------------------------------------------------------------------------------------------------- 2002 2003 ---------------------------------------------------------------------------------------------------- Divisional Identity Market New Business Descriptor ---------------------------------------------------------------------------------------------------- Scimed Markets devices to * Interventional Cardiology interventional * Peripheral Interventions cardiologists, interventional radiologists and vascular surgeons for the diagnosis and treatment of coronary and peripheral vascular disease and other cardiovascular disorders. ---------------------------------------------------------------------------------------------------- Target Markets a line of * Neurovascular micro-guidewires, micro-catheters, coils, embolics and other medical devices which aid neuroradiologists and neurosurgeons in the treatment of neurovascular diseases. ---------------------------------------------------------------------------------------------------- EP Technologies Offers a * Electrophysiology line of electrophysiology catheters and systems for use by interventional electrophysiologists in the diagnosis and treatment of tachyarrhythmias. ---------------------------------------------------------------------------------------------------- Medi-tech Markets devices to * Vascular Surgery cardiologists, interventional radiologists and vascular surgeons who treat abdominal aortic aneurysmal disease. ---------------------------------------------------------------------------------------------------- |
Endosurgery Group
----------------------------------------------------------------------------------------------------- 2002 2003 ----------------------------------------------------------------------------------------------------- Divisional Identity Market New Business Descriptor ----------------------------------------------------------------------------------------------------- Microvasive Endoscopy Markets therapeutic, * Endoscopy diagnostic and palliative devices, which aid gastroenterologists and pulmonologists in performing flexible endoscopic procedures involving the digestive tract and lungs. ----------------------------------------------------------------------------------------------------- Microvasive Urology Offers a line * Urology of therapeutic and * Gynecology diagnostic devices which aid urologists and urogynecologists in performing ureteroscopic and other less-invasive endoscopic procedures as well as devices to treat urinary incontinence and abnormal bleeding. ----------------------------------------------------------------------------------------------------- Medi-tech Markets devices to * Oncology interventional radiologists and surgical oncologists who treat diseases requiring management of cancerous and non-cancerous tumors as well as patients requiring venous access. ----------------------------------------------------------------------------------------------------- |
A dedicated sales force of approximately 1,200 individuals in over 40 countries internationally and over 800 in the United States marketed the Company's products worldwide as of December 31, 2002. Sales in countries where the Company has direct sales organizations accounted for approximately 99% of the Company's net sales during 2002. A network of distributors and dealers who offer the Company's products in more than 35 countries worldwide accounts for the remaining sales. The Company also has a dedicated corporate sales organization in the United States focused principally on selling to major buying groups and large integrated health care networks.
In 2002, the Company sold its products to over 10,000 hospitals, clinics, out-patient facilities and medical offices. The Company is not dependent on any single institution and no single institution accounted for more than 10% of the Company's net sales in 2002. Large group purchasing organizations, hospital networks and other buying groups have, however, become increasingly important to the Company's business. The trend toward managed care and economically motivated and more sophisticated buyers in the United States may result in continued pressure on selling prices of certain products and resulting compression on gross margins. These purchasers of medical devices also tend to limit the number of suppliers from whom they purchase medical
products. There can be no assurance that these entities will continue to purchase products from the Company.
The Company also distributes certain products for third parties, including an introducer sheath and certain guidewires. Together, these distributed products represented less than 10% of the Company's 2002 net sales. Leveraging its sales and marketing strength, the Company expects to continue to seek new opportunities for distributing complementary products as well as new technologies. The Company expects that it will continue to enter into distribution arrangements that include options to acquire technology from third parties at pre-established future dates. These distribution arrangements often allow the Company to evaluate new technologies prior to acquisition.
INTERNATIONAL OPERATIONS
Internationally, the Company operates through three business segments divided among the geographic regions of Europe, Japan and Inter-Continental. Maintaining and expanding its international presence is an important component of the Company's long-term growth plan. Through its international presence, the Company seeks to increase net sales and market share, leverage relationships with leading physicians and their clinical research programs, accelerate the time within which new products can be brought to market and gain access to worldwide technological developments that may be implemented across its product lines.
In 2002, international sales accounted for approximately 40% of the Company's net sales. Net sales, operating income (excluding special charges) and total assets attributable to significant geographic areas are presented in Note P to the Company's 2002 Consolidated Financial Statements, which are filed with the Securities and Exchange Commission as an exhibit to this document.
In recent years, the Company has expanded its direct sales presence worldwide so as to be in a position to take advantage of expanding market opportunities. As of December 31, 2002, the Company had direct marketing and sales operations in over 40 countries internationally. The Company believes that it will continue to leverage its infrastructure in markets where commercially appropriate and to use third parties in those smaller markets where it is not economical or strategic to establish a direct presence.
The Company has four international manufacturing facilities in Ireland. Presently, approximately 30% of the Company's products sold worldwide are manufactured at these facilities. The Company also maintains an international research and development facility in Ireland and a training and research and development center in Miyazaki, Japan.
The Company's international presence exposes it to certain financial and other risks. Principal among these is the potentially negative impact of foreign currency fluctuations on the Company's sales and expenses. Although the Company engages in nonspeculative hedging transactions that may offset the effect of fluctuations in foreign currency exchange rates on foreign currency denominated assets, liabilities, earnings and cash flows, financial exposure may
nonetheless result, primarily from the timing of transactions, forecast volatility and the movement of exchange rates. International markets are also being affected by economic pressure to contain reimbursement levels and health care costs. The Company's profitability from its international operations may be limited by risks and uncertainties related to economic conditions in these regions, regulatory and reimbursement approvals, competitive offerings, infrastructure development, rights to intellectual property, and the ability of the Company to implement its overall business strategy. Any significant changes in the competitive, political, regulatory, reimbursement or economic environment where the Company conducts international operations may have a material impact on revenues and profits, especially in Japan, given its high profitability relative to its contribution to revenues. The Company's Japan business is expected to be under continued pressure, particularly in the coronary stent market, due to competitive product offerings and the lack of physician acceptance of the NIR(R) coronary stent platform. Deterioration in the Japanese and/or Inter-Continental economies may impact the Company's ability to grow its business and to collect its accounts receivable in international markets. Additionally, the trend in countries around the world toward more stringent regulatory requirements for product clearance, changing reimbursement models and more vigorous enforcement activities has generally caused or may cause medical device manufacturers to experience more uncertainty, greater risk and higher expenses.
MANUFACTURING; RAW MATERIALS
The Company designs and manufactures the majority of its products in twenty technology centers around the world. During 2000, the Company approved and committed to a global operations plan consisting of a series of strategic initiatives designed to increase productivity and enhance innovation. The plan includes manufacturing process and supply chain programs and a plant optimization initiative. During the second quarter of 2002, the Company substantially completed its plant optimization initiative. The plant optimization initiative has created a better allocation of the Company's resources by forming a more effective network of manufacturing and research and development facilities. The Company's plan resulted in the consolidation of manufacturing operations along product lines and the shifting of significant amounts of production to the Company's facilities in Miami and Ireland and to contract manufacturing. The Company's plan included the discontinuation of manufacturing activities at three facilities in the United States, and included the planned displacement of approximately 1,950 manufacturing, manufacturing support and management employees.
Most components used in the manufacture of the Company's products are readily fabricated from commonly available raw materials or off-the-shelf items available from multiple supply sources. The fabricated items are custom made for the Company to meet its specifications. The Company believes that in most cases, redundant capacity exists at the suppliers and that alternative sources of supply are available or could be developed within a reasonable period of time. Generally, the Company has been able to obtain adequate supplies of raw materials and components in a timely manner from established sources. In certain cases, the Company may not be able to quickly establish additional or replacement suppliers for specific components or materials, largely due to the FDA approval system and other regulatory requirements and the complex nature of the manufacturing processes employed by the Company and many suppliers.
The reduction or interruption in supply, an inability to develop and validate alternative sources if required, or a significant increase in the price of raw materials or components could adversely affect the Company's operations and financial condition.
QUALITY ASSURANCE
The Company is committed to providing high quality products to its customers. To meet this commitment, the Company has implemented state-of-the-art quality systems and concepts throughout the organization. The Company's quality system starts with the initial product specification and continues through the design of the product, component specification process and the manufacturing, sales and servicing of the product. The quality system is designed to build in quality and to utilize continuous improvement concepts throughout the product life. These systems enable the Company to satisfy the quality system regulations of the FDA with respect to products sold the United States. Many of the Company's operations are certified under ISO 9001, ISO 9002, ISO 13485, ISO 13488, EN46001 and EN46002 international quality system standards. ISO 9002 requires, among other items, an implemented quality system that applies to component quality, supplier control and manufacturing operations. In addition, ISO 9001 and EN46001 require an implemented quality system that applies to product design. These certifications can be obtained only after a complete audit of a company's quality system by an independent outside auditor. Maintenance of these certifications requires that these facilities undergo periodic reexamination. During 2002, the Company established an initiative to seek ISO 14001 certification at various plants around the world. The ISO 14001, a standard in the ISO 14000 series, provides a voluntary approach regarding environmental management systems that helps organizations assure positive environmental performance. This initiative will continue until our facilities become certified. In March 2003, the Company received corporate certification to ISO 9001, MDD and EN 46001 standards.
COMPETITION
The Company encounters significant competition across its product lines and in each market in which its products are sold from various entities, some of which may have greater financial and marketing resources than the Company. The Company's primary competitors include: Abbott Laboratories, Inc., C.R. Bard, Inc., Cook, Inc., Guidant Corporation (including its subsidiary Advanced Cardiovascular Systems, Inc.), Johnson & Johnson (including its subsidiary, Cordis Corporation), Medtronic, Inc. (including its subsidiary, Medtronic AVE, Inc.) and Tyco International, as well as a wide range of companies which sell a single or limited number of competitive products or participate only in specific market segment. In addition, the worldwide coronary stent market is dynamic and highly competitive, with significant market share volatility. Technology and competitive offerings, particularly a competitor's prior entry in the drug-eluting stent market, may negatively impact the Company's revenues. The Company also faces competition from non-medical device companies, such as pharmaceutical companies, which may offer non-surgical alternative therapies for disease states which are currently or intended to be treated using the Company's products.
The Company believes that its products compete primarily on the basis of their ability to safely and effectively perform diagnostic and therapeutic procedures in a less-invasive manner, ease of product use, product reliability and physician familiarity. In the current environment of managed care, economically motivated buyers, consolidation among health care providers, increased competition and declining reimbursement rates, the Company has also been increasingly required to compete on the basis of price, value and efficiency. The Company believes that its continued competitive success will depend upon its ability to create or acquire scientifically advanced technology, apply its technology cost-effectively across product lines and markets, develop or acquire proprietary products, attract and retain skilled development personnel, obtain patent or other protection for its products, obtain required regulatory and reimbursement approvals, manufacture and successfully market its products either directly or through outside parties and supply sufficient inventory to meet customer demand.
RESEARCH AND DEVELOPMENT
Enhancements of existing products or expansions of existing product lines, which are typically developed within the Company's manufacturing and marketing operations, contribute to each year's sales growth. The Company believes that streamlining, prioritization and coordination of its technology pipeline and new product development activities are essential to its ability to stimulate growth and maintain leadership positions in its markets. By centralizing platform technology development at the corporate level, the Company is able to pursue technologies that can be leveraged across multiple markets. The Company's approach to new product design and development is through focused, cross functional efforts. The Company believes that its formal process for technology and product development aids in its ability to offer innovative and manufacturable products in a consistent and timely manner. Involvement of the R&D, clinical, quality, regulatory, manufacturing and marketing teams early in the process is the cornerstone of a product development cycle. This collaboration allows the team to concentrate resources on the most viable and profitable new products and technologies and get them to market in a timely manner.
In 2002, the Company expended approximately $343 million on research and development, representing approximately 12 percent of the Company's 2002 net sales. The investment in research and development dollars reflects spending on new product development programs as well as regulatory compliance and clinical research. The increase in research and development expense from 2001 levels is primarily due to investment in the development of, and clinical trials related to, the Company's TAXUS(TM) drug-eluting stent program and to investment in development programs acquired in connection with the Company's business combinations. The Company currently anticipates research and development expenses as a percentage of net sales to remain at approximately 12 percent in 2003. There can be no assurance, however, that the Company's performance will not be affected by management's decisions relating to investments in research and development at anticipated levels during 2003.
In addition to internal development, the Company works with hundreds of leading research institutions, universities and clinicians around the world in developing, evaluating and clinically testing its products. The Company believes its future success will depend upon the strength of its development efforts. There can be no assurance that the Company will realize financial benefit from its development programs, will continue to be successful in identifying, developing and marketing new products or enhancing its existing products, or that products or technologies developed by others will not render the Company's products or technologies non-competitive or obsolete.
REGULATION
The medical devices manufactured and marketed by the Company are subject to regulation by numerous regulatory bodies, including the FDA and comparable international regulatory agencies. These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of medical devices. Devices are generally subject to varying levels of regulatory control, the most comprehensive of which requires that a clinical evaluation program be conducted before a device receives approval for commercial distribution.
In the United States, permission to distribute a new device generally can be met in one of two ways. The first process requires that a pre-market notification (the "510(k) Submission") be made to FDA to demonstrate that the device is as safe and effective, that is, substantially equivalent to a legally marketed device that is not subject to pre-market approval ("PMA"). Applicants must compare this device to one or more similar devices commercially available in the United States and make and support their substantial equivalency claims. A legally marketed device is a device that (i) was legally marketed prior to May 28, 1976, (ii) has been reclassified from Class III to Class II or I, or (iii) has been found to be substantially equivalent to a device following a 510(k) Submission. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s). Applicants must submit descriptive data and, when necessary, performance data to establish that the device is substantially equivalent to a predicate device. In some instances, data from human clinical trials must also be submitted in support of a
510(k) Submission. If so, these data must be collected in a manner that conforms with specific requirements in accordance with federal regulations. The FDA must issue an order finding substantial equivalence before commercial distribution can occur.
Changes to existing devices covered by a 510(k) Submission which do not significantly affect safety or effectiveness can generally be made by the Company without additional 510(k) Submissions.
The second process requires that an application for PMA be made to the FDA to demonstrate that the device is safe and effective for its intended use as manufactured. This approval process applies to certain Class III devices. In this case, two steps of FDA approval are generally required before marketing in the United States can begin. First, the Company must comply with investigational device exemptions ("IDE") regulations in connection with any human clinical investigation of the device in the United States. Second, the FDA must review the Company's PMA application which contains, among other things, clinical information acquired under the IDE. The FDA will approve the PMA application if it finds that there is a reasonable assurance that the device is safe and effective for its intended purpose.
The FDA can ban certain medical devices, detain or seize adulterated or misbranded medical devices, order repair, replacement or refund of these devices, and require notification of health professionals and others with regard to medical devices that present unreasonable risks of substantial harm to the public health. The FDA may also enjoin and restrain certain violations of the Food, Drug and Cosmetic Act and the Safe Medical Devices Act pertaining to medical devices, or initiate action for criminal prosecution of such violations. International sales of medical devices manufactured in the United States that are not approved by the FDA for use in the United States, or are banned or deviate from lawful performance standards, are subject to FDA export requirements. The Export Reform Act of 1996 has simplified the process of exporting devices which have not been approved for sale in the United States.
Exported devices are subject to the regulatory requirements of each country to which the device is exported. Some countries do not have medical device regulations, but in most foreign countries medical devices are regulated. In many of these countries the medical device regulations are similar to drug regulations. The majority of the Company's products are expected to be so regulated in these countries. Frequently, regulatory approval may first be obtained in a foreign country prior to application in the United States to take advantage of differing regulatory requirements. The Company has completed CE Mark registrations for substantially all of its products in accordance with the implementation of various medical device directives in the European Union.
The process of obtaining clearance to market products is costly and time-consuming in virtually all of the major markets in which the Company sells products and can delay the marketing and sale of new products. Countries around the world have recently adopted more stringent regulatory requirements which are expected to add to the delays and uncertainties associated with new product releases, as well as the clinical and regulatory costs of supporting such releases. No assurance can be given that any of the Company's new medical devices will be
approved on a timely basis, if at all. In addition, regulations regarding the development, manufacture and sale of medical devices are subject to future change. The Company cannot predict what impact, if any, such changes might have on its business. Failure to comply with regulatory requirements could have a material adverse effect on the Company's business, financial condition and results of operations.
The Company is also subject to environmental laws and regulations both in the United States and abroad. The operations of the Company, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. The Company believes that compliance with environmental laws will not have a material impact on its financial position, results of operations, or liquidity. Given the scope and nature of these laws, there can, however, be no assurance that environmental laws will not have a material impact on the Company.
THIRD-PARTY COVERAGE AND REIMBURSEMENT
The Company's products are purchased by hospitals, doctors and other health care providers who are reimbursed for the health care services provided to their patients by third-party payors, such as governmental programs (e.g., Medicare and Medicaid), private insurance plans and managed care programs. Third party payors may provide or deny coverage for certain technologies and associated procedures based on assessment criteria as determined by the third-party payor. Reimbursement by third-party payors for these services is based on a wide range of methodologies that may reflect the services' assessed resource costs, clinical and economic value. These reimbursement methodologies confer different, and often conflicting, levels of financial risk and incentives to health care providers and patients, and these methodologies are subject to frequent refinements. Third party payers are also increasingly adjusting reimbursement rates and challenging the prices charged for medical products and services. There can be no assurance that the Company's products will be automatically covered by third-party payors, that reimbursement will be available or, if available, that the third-party payors' coverage policies will not adversely affect the Company's ability to sell its products profitably.
Initiatives to limit the growth of healthcare costs, including price regulation, are also underway in many countries in which the Company does business. Implementation of healthcare reforms in significant markets such as Japan, Europe, and other countries may limit the price of, or the level at which reimbursement is provided for, the Company's products and may influence a physician's selection of products used to treat patients.
PROPRIETARY RIGHTS AND PATENT LITIGATION
The Company relies on a combination of patents, trademarks, trade secrets and non-disclosure agreements to protect its intellectual property. The Company generally files patent applications in the United States and foreign countries where patent protection for its technology is appropriate and available. The Company holds more than 2,800 United States patents (many of which have foreign counterparts) and has more than 4,600 patent applications pending worldwide that cover various aspects of its technology. In addition, the Company holds exclusive and non-exclusive licenses to a variety of third party technologies covered by patents and patent applications. There can be no assurance that pending patent applications will result in issued patents, that patents issued to or licensed by the Company will not be challenged or circumvented by competitors, or that such patents will be found to be valid or sufficiently broad to protect the Company's technology or to provide the Company with a competitive advantage.
The Company relies on non-disclosure and non-competition agreements with employees, consultants and other parties to protect, in part, trade secrets and other proprietary technology. There can be no assurance that these agreements will not be breached, that the Company will have adequate remedies for any breach, that others will not independently develop equivalent proprietary information or that third parties will not otherwise gain access to the Company's trade secrets and proprietary knowledge.
There has been substantial litigation regarding patent and other intellectual property rights in the medical device industry, particularly in the areas in which the Company competes. The Company has defended, and will likely continue to defend, itself against claims and legal actions alleging infringement of the patent rights of others. Adverse determinations in any patent litigation could subject the Company to significant liabilities to third parties, require the Company to seek licenses from third parties, and, if licenses are not available, prevent the Company from manufacturing, selling or using certain of its products, some of which could have a material adverse effect on the Company.
Additionally, the Company may find it necessary to initiate litigation to enforce its patent rights, to protect its trade secrets or know-how and to determine the scope and validity of the proprietary rights of others. Patent litigation can be costly and time-consuming, and there can be no assurance that the Company's litigation expenses will not be significant in the future or that the outcome of litigation will be favorable to the Company. Accordingly, the Company may seek to settle some or all of its pending litigation. Settlement may include cross-licensing of the patents which are the subject of the litigation as well as other intellectual property of the Company and may involve monetary payments to or from third parties.
OTHER LITIGATION AND RISK MANAGEMENT
The testing, marketing and sale of human health care products entails an inherent risk of product liability claims. The Company is involved in various lawsuits arising in the normal course of business from product liability claims, and product liability claims may be asserted in the future relative to events not known to management at the present time. As a result of current economic factors impacting the insurance industry, at the beginning of the third quarter of 2002, the Company elected to become substantially self-insured with respect to general and product liability claims. Losses for claims in excess of the limits of purchased insurance would be recorded at the time and to the extent they are probable and estimable. Management believes that the Company's risk management practices, including limited insurance coverage, are reasonably adequate to protect against anticipated general and product liability losses. However, unanticipated catastrophic losses could have a material adverse impact on the Company's financial position, results of operations and liquidity.
See the "Legal Proceedings" section below and Note L - Commitments and Contingencies to the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) for a further discussion of patent and other litigation and proceedings involving the Company.
EMPLOYEES
As of December 31, 2002, the Company had approximately 13,900 employees, including more than 7,800 in operations, 1,400 in administration, 1,400 in clinical and research and development and 3,200 in selling, marketing, distribution and related administrative support. Of these employees, approximately 2,100 were employed in the Company's international operations. The Company believes that the continued success of its business will depend, in part, on its ability to attract and retain qualified personnel.
SEASONALITY
Worldwide sales do not reflect any significant degree of seasonality, however customer purchases have been lighter in the third quarter of prior years than in other quarters. This reflects, among other factors, lower demand during summer months, particularly in European countries.
CAUTIONARY STATEMENT FOR PURPOSES OF THE SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
The Cautionary Statement for Purposes of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995 appearing on pages 15 through 16 of the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) is incorporated herein by reference.
ITEM 2. PROPERTIES
The Company's world headquarters are located in Natick, Massachusetts. It maintains regional headquarters in Tokyo, Japan; Paris, France; and Singapore. As of December 31, 2002, the Company's manufacturing, research, distribution and other key facilities totaled approximately 5 million square feet, of which approximately 50% was owned by the Company and the balance was leased. As of December 31, 2002, the Company's principal technology centers were located in Massachusetts, Indiana, Minnesota, New Jersey, Florida, California, Utah, New York and Ireland, and its distribution centers were located in Massachusetts, The Netherlands and Japan. As of December 31, 2002, the Company maintained twenty technology centers, sixteen in the United States and four in Ireland. Many of these facilities produce and manufacture products for more than one of the Company's divisions and include research facilities. The Company believes that its facilities are adequate to meet its current needs and continues to assess its plant network strategy.
ITEM 3. LEGAL PROCEEDINGS
Note L - Commitments and Contingencies to the Company's 2002 Consolidated Financial Statements, appearing on pages 36 through 43 thereto (Exhibit 13.1 filed herewith), is incorporated herein by reference. The following paragraphs update the disclosure appearing in Note L.
RECENT PATENT LITIGATION ACTIVITY
Litigation with Johnson & Johnson
On March 13, 2002, the Company and Boston Scientific Scimed, Inc. filed suit for
patent infringement against the Johnson & Johnson and Cordis Corporation
(Cordis), a subsidiary of Johnson & Johnson, alleging that its Cypher(TM)
drug-eluting stent infringes a patent owned by the Company. The suit was filed
in the District Court of Delaware seeking monetary and injunctive. On March 20,
2003, the Company filed a motion seeking a preliminary injunction with respect
to the sale of the Cypher stent in the United States.
On January 13, 2003, Cordis filed suit for patent infringement against the Company and Scimed Life Systems, Inc. (SCIMED) alleging the Company's Express(2)(TM) coronary stent is infringed by a U.S. patent owned by Cordis. The suit was filed in the U.S. District Court for the District of Delaware seeking monetary and injunctive relief. On February 14, 2003, Cordis filed a motion requesting a preliminary injunction. On March 5, 2003, the Company answered the complaint,
denying the allegations, and filed a counterclaim against Cordis, alleging that certain products sold by Cordis infringe a patent owned by the Company. A hearing on the preliminary injunction motion has been scheduled for June 23 and 24, 2003, with post-hearing briefing to follow.
On February 20, 2003, Janssen Pharmaceuticals NV, an affiliate of Johnson & Johnson, filed suit against the Company (through its subsidiaries) and Medinol alleging that BX Velocity stents manufactured in Belgium do not infringe a European patent owned by Medinol and exclusively licensed to the Company. The suit was filed in Belgium seeking a declaration of invalidity and noninfringement of the Medinol patent and monetary relief. A hearing is scheduled for June 16, 2003.
On March 30, 2000, the Company (through its subsidiary) filed suit for patent infringement against two subsidiaries of Cordis alleging that Cordis' BX Velocity stent delivery system infringes a published utility model owned by Medinol and exclusively licensed to the Company. The complaint was filed in the District Court of Dusseldorf, Germany seeking monetary and injunctive relief. A hearing was held on March 15, 2001, and on June 6, 2001, the Court issued a written decision that Cordis' BX Velocity stent delivery system infringes the Medinol published utility model. Cordis appealed the decision of the German court. A hearing on the appeal has been suspended until a decision is rendered in a related action pending in the U.S. District Court for the Southern District of New York between the Company and Medinol.
Litigation with Guidant Corporation
On December 3, 2002, Advanced Cardiovascular Systems, Inc. (ACS), a subsidiary of Guidant Corporation (Guidant), filed suit for patent infringement against the Company and SCIMED alleging the Company's Express(TM) stent infringes a U.S. patent owned by ACS. The suit was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief. On January 30, 2003, the Company filed an answer denying allegations of the complaint and concurrently filed a counterclaim seeking declaratory judgment of patent invalidity and noninfringement and alleging that certain ACS products infringe five U.S. patents owned by the Company. The Company seeks monetary and injunctive relief. On March 17, 2003, ACS filed an amended complaint alleging an additional patent is infringed by the Company's product.
On December 30, 2002, the Company and certain of its subsidiaries filed suit for patent infringement against Guidant, and Guidant Sales Corporation and ACS alleging that certain stent delivery systems (Multi-Link Zeta(TM) and Multi-Link Penta(TM)) and balloon catheter products (Agil-Trac(TM)) sold by Guidant and ACS infringe nine U.S. patents owned by the Company. The complaint was filed in The U.S. District Court for the Northern District of California seeking monetary and injunctive relief. On February 21, 2003, Guidant filed an answer denying the allegations of the complaint and filed a counterclaim seeking declaratory judgment of patent invalidity and noninfringement and alleging that certain Company products infringe patents owned by ACS. A scheduling conference has been set for May 9, 2003.
On July 30, 2002, Guidant and Cook Group Incorporated, the parent of Cook, Inc. announced their agreement to merge Cook Group Incorporated into a wholly-owned subsidiary of Guidant. On the same day, Guidant filed suit against the Company seeking a declaratory judgment that
upon completion of the merger, the license granted under the License Agreement among Angiotech Pharmaceuticals, Inc. (Angiotech), Cook and the Company may be assigned or sublicensed by Cook to ACS and that ACS is entitled to use the information, data or technology generated or gathered for the purposes of obtaining regulatory approval for a coronary stent utilizing the Angiotech technology. The Company answered the complaint and counterclaimed for declaratory and injunctive relief alleging that Guidant is tortiously interfering with Cook's performance under the Agreement. Guidant has announced the termination of their agreement to merge with Cook, and on March 13, 2003, the Company and Guidant filed a joint motion to dismiss the claims and counterclaims between the parties without prejudice. On March 14, 2003, the Court granted the joint motion.
On June 30, 1998, Cook, Inc. (Cook), filed suit in the Regional Court, Dusseldorf Division for Patent Disputes, in Dusseldorf, Germany against the Company alleging that the Company's Passager(TM) peripheral vascular stent graft and Vanguard(TM) endovascular aortic graft products infringe the same Cook patent. A hearing was held on July 22, 1999, and a decision was received in September 1999 finding that the Company's products infringe the Cook patent. The Company appealed the decision. The hearing originally scheduled for March 27, 2003 has been postponed until March 25, 2004.
Litigation with Medinol Ltd.
On September 10, 2002, the Company filed suit against Medinol Ltd. (Medinol) alleging Medinol's NIRFlex(TM) and NIRFlex(TM) Royal products infringe two patents owned by the Company. The suit was filed in Dusseldorf, Germany seeking monetary and injunctive relief. A hearing previously scheduled for February 4, 2003 has been rescheduled for September 23, 2003.
Other Proceedings
On October 31, 2000, the Federal Trade Commission (FTC) filed suit against the Company for alleged violations of a Consent Order dated May 5, 1995, pursuant to which the Company had licensed certain intravascular ultrasound technology to Hewlett-Packard Company (HP). The suit was filed in the U.S. District Court for the District of Massachusetts seeking civil penalties and injunctive relief. The Company filed a motion to dismiss the complaint and the FTC filed a motion for summary judgment. On October 5, 2001, the Court dismissed three of the five claims against the Company and granted summary judgment of liability in favor of the FTC on the two remaining claims. On March 28, 2003, the Court entered a judgment against the Company in the amount of approximately $7 million. The Company is evaluating whether to appeal the judgment.
The Company is involved in various lawsuits from time to time. In management's opinion, the Company is not currently involved in any legal proceedings other than those specifically identified above or in Note L - Commitments and Contingencies to the Company's 2002 Consolidated Financial Statements which, individually or in the aggregate, could have a material effect on the financial condition, operations or cash flows of the Company.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
DIRECTORS AND EXECUTIVE OFFICERS OF THE COMPANY
The Directors and executive officers of the Company as of December 31, 2002 were as follows:
DIRECTORS:
John E. Abele 65 Director, Founder Ursula M. Burns 44 Director, Senior Corporate Vice President and President, Business Group Operations, Xerox Corporation Joseph A. Ciffolillo 64 Director, Private Investor Joel L. Fleishman 68 Director, Senior Advisor to the Atlantic Philanthropies and Professor of Law and Public Policy, Duke University Marye Anne Fox, Ph.D. 55 Director, Chancellor of North Carolina State University Ray J. Groves 67 Director, President and Chief Executive Officer of Marsh Inc. Lawrence L. Horsch 68 Director, Chairman of Eagle Management & Financial Corp. Ernest Mario, Ph.D. 64 Director, Chairman and Chief Executive Officer, IntraBiotics Pharmaceuticals, Inc. N.J. Nicholas, Jr. 63 Director, Private Investor Peter M. Nicholas 61 Director, Founder, Chairman of the Board Uwe E. Reinhardt, Ph.D. 65 Director, James Madison Professor, Princeton University Senator Warren B. Rudman 72 Director, Former U.S. Senator, Partner, Paul, Weiss, Rifkind, Wharton, & Garrison James R. Tobin 58 Director, President and Chief Executive Officer |
At the Company's 2003 Annual Meeting of Stockholders, stockholders will be asked to vote for the election of John E. Pepper, age 64, to serve as a Class III member of the Board of Directors of the Company. Mr. Lawrence L. Horsch, a Class II Director, is retiring from the Board and will not be standing for re-election.
EXECUTIVE OFFICERS:
Lawrence C. Best 52 Senior Vice President-Finance & Administration and Chief Financial Officer Fredericus A. Colen 50 Senior Vice President and Chief Technology Officer Paul Donovan 47 Vice President, Corporate Communications Paul A. LaViolette 45 Senior Vice President and Group President, Cardiovascular Robert G. MacLean 59 Senior Vice President-Human Resources Stephen F. Moreci 51 Senior Vice President and Group President, Endosurgery Paul W. Sandman 55 Senior Vice President, Secretary and General Counsel James H. Taylor, Jr. 63 Senior Vice President, Corporate Operations James R. Tobin 58 Director, President and Chief Executive Officer |
On February 25, 2003, Dennis A. Ocwieja, age 57, was appointed to the Executive Committee of the Company as Senior Vice President - Regulatory Affairs.
COMMITTEES OF THE BOARD OF DIRECTORS
The Board of Directors of the Company has standing Audit, Executive Compensation and Human Resources, Strategic Investment and Governance Committees. Joel L. Fleishman, Marye Anne Fox, Ernest Mario, Uwe E. Reinhardt, and Warren B. Rudman currently serve on the Audit Committee. Ursula M. Burns, Joseph A. Ciffolillo, Ray J. Groves, and Lawrence L. Horsch currently serve on the Executive Compensation and Human Resources Committee. Ursula M. Burns, Joseph A. Ciffolillo, Marye Anne Fox, Ernest Mario, N.J. Nicholas, Jr. and James R. Tobin currently serve on the Strategic Investment Committee. Joel L. Fleishman, Ray J. Groves, Peter M. Nicholas, Uwe E. Reinhardt, and Warren B. Rudman currently serve on the Governance Committee. A description of the committees of the Board of Directors of the Company is set forth in the Company's definitive Proxy Statement to be filed with the Commission on or about April 4, 2003, and is incorporated herein by reference.
BIOGRAPHICAL SUMMARIES
John E. Abele, a co-founder of the Company, has been a Director of the Company since 1979 and Founder Chairman since 1995. Mr. Abele held the position of Treasurer from 1979 to 1992, Co-Chairman from 1979 to 1995 and Vice Chairman and Founder, Office of the Chairman from February 1995 to March 1996. He was President of Medi-tech, Inc. from 1970 to 1983, and prior to that served in sales, technical and general management positions for Advanced Instruments, Inc. Mr. Abele is the Chairman of the Board of the FIRST (For Inspiration and Recognition of Science and Technology) Foundation and is also a member of numerous not-for-profit boards. Mr. Abele received a B.A. degree from Amherst College.
Lawrence C. Best has served as Senior Vice President and Chief Financial Officer for the Company since 1992. Prior to his work with the Company, Mr. Best was a partner in the accounting firm of Ernst & Young, where he specialized in serving multinational companies in the high technology and life sciences fields. He served a two-year fellowship at the Securities and Exchange Commission from 1979 to 1981 and a one-year term as a White House-appointed Presidential Exchange Executive in Washington, D.C. He serves on the Board of Directors of Biogen, Inc. Mr. Best received a B.B.A. degree from Kent State University.
Ursula M. Burns became a Director of the Company in 2002. Ms. Burns is President of the Business Group Operations and Corporate Senior Vice President of Xerox Corporation. Ms. Burns joined Xerox in 1980, advancing through several engineering and management positions. Ms. Burns served as Vice President and General Manager, Departmental Business Unit from 1997 to 1999, Senior Vice President, Worldwide Manufacturing and Supply Chain Services from 1999 to 2000, Senior Vice President, Corporate Strategic Services from 2000 to October 2001 and President of Document Systems and Solutions Group until her most recent appointment in January 2003. She serves on the Boards of Directors of Banta Corporation, the National Association of Manufacturers, the University of Rochester and the Rochester Business Alliance. Ms. Burns earned a Bachelor of Science degree from Polytechnic Institute of New York and a Master of Science degree in mechanical engineering from Colombia University.
Joseph A. Ciffolillo joined the Company in 1983 as President of Medi-tech, Inc. During his tenure at the Company, he also served as President of Microvasive, Inc. and as Executive Vice President and Chief Operating Officer from 1989 until his retirement in 1996. In 1992, Mr. Ciffolillo became a director of the Company. Previously, Mr. Ciffolillo spent twenty years with Johnson & Johnson where he held a number of management positions including President, Johnson & Johnson Orthopedic Company. Mr. Ciffolillo is a member of the Spray Venture Fund Investment Committee and a member of the Board of Directors of MedSource Technologies, Inc. He also serves on a number of for-profit and not-for-profit boards. Mr. Ciffolillo is Chairman of the Advisory Board of the Health Science Technology Division of Harvard University and the
Massachusetts Institute of Technology. He is also Chairman of the President's Council of the Massachusetts General Hospital and a Director of South Coast Health Systems. Mr. Ciffolillo received his B.A. from Bucknell University, where he also serves as a Member of the Board of Trustees.
Fredericus A. Colen was appointed to the Executive Committee of the Company in July 2001 as Senior Vice President and Chief Technology Officer. Mr. Colen joined the Company in 1999 as Vice President of Research and Development of Scimed and, in February 2001, he was promoted to Senior Vice President, Cardiovascular Technology of Scimed. Before joining the Company, he worked for several medical device companies, including Guidant, where he launched the Delta T DDD Pacemaker platform, and St. Jude Medical, where he served as Managing Director for the European subsidiary of the Cardiac Rhythm Management Division and as Executive Vice President, responsible for worldwide R & D for implantable pacemaker systems. Mr. Colen was educated in The Netherlands and Germany and holds the U.S. equivalent of a Master's Degree in Electrical Engineering with focus on medical technology from the Technical University in Aachen, Germany. He was the Vice President of the International Association of Prosthesis Manufacturers (IAPM) in Brussels from 1995 to 1997.
Paul Donovan joined the Company in March 2000 as Vice President, Corporate Communications. Most recently, Mr. Donovan was the Executive Director of External Affairs at Georgetown University Medical Center, where he directed media, government and community relations as well as employee communications since 1998. From 1997 to 1998, Mr. Donovan was Chief of Staff at the United States Department of Commerce. From 1993 to 1997, Mr. Donovan served as Chief of Staff to Senator Edward M. Kennedy and from 1989 to 1993 as Press Secretary to Senator Kennedy. Mr. Donovan received a B.A. degree from Dartmouth College.
Joel L. Fleishman joined the Company as a Director in October 1992. Mr. Fleishman served as President of The Atlantic Philanthropies from September 1993 until January 2001, when he became Senior Advisor of that organization. He is also Professor of Law and Public Policy and has served in various administrative positions, including First Senior Vice President at Duke University, since 1971. Mr. Fleishman is a founding member of the governing board of the Duke Center for Health Policy Research and Education and was the founding director of Duke University's Terry Sanford Institute of Public Policy. He is the director of the Samuel and Ronnie Heyman Center for Ethics, Public Policy and the Professions. Mr. Fleishman also serves as Chairman of the Board of Trustees of The John and Mary Markle Foundation, Vice-Chairman of the Board of Trustees of the Urban Institute and as a director of Polo Ralph Lauren Corporation. Mr. Fleishman received A.B., M.A. and J.D. degrees from the University of North Carolina at Chapel Hill, and an LL.M. degree from Yale University.
Marye Anne Fox became a Director of the Company in October 2001. Dr. Fox is Chancellor of North Carolina State University and Distinguished University Professor of Chemistry. From 1976 to 1998, she was a member of the faculty at the University of Texas, where she taught chemistry and held the Waggoner Regents Chair in Chemistry from 1991 to 1998. She served as the University's Vice President for Research from 1994 to 1998. Dr. Fox is the Co-Chair of the
National Academy of Sciences' Government-University-Industry Research Roundtable and serves on President Bush's Council of Advisors on Science and Technology. She has served as the Vice Chair of the National Science Board. She also serves on the boards of a number of other scientific, technological and civic organizations, and is a member of the Boards of Directors of Red Hat Corp., Pharmaceutical Product Development, Inc., Burroughs-Wellcome Trust and the Camille and Henry Dreyfus Foundation. Dr. Fox also serves on the Board of Directors of W.R. Grace Co., a specialty chemical company that filed a petition for reorganization under Chapter 11 of the Federal Bankruptcy Code in April 2001. She has been honored by a wide range of educational and professional organizations, and she has authored more than 350 publications, including five books. Dr. Fox holds a B.S. in Chemistry from Notre Dame College, an M.S. in Organic Chemistry from Cleveland State University, and a Ph.D. in Organic Chemistry from Dartmouth College.
Ray J. Groves joined the Company as a Director in May 1999. Mr. Groves is President and Chief Executive Officer of Marsh Inc., a subsidiary of Marsh & McLennan Companies, Inc. He served as Chairman of Legg Mason Merchant Banking, Inc. from 1995 to 2001. Mr. Groves served as Chairman and Chief Executive Officer of Ernst & Young for 17 years until his retirement in 1994. Mr. Groves currently serves as a member of the Boards of Directors of Electronic Data Systems Corporation, The Gillette Company, and Marsh & McLennan Companies, Inc. Mr. Groves serves on the Board of Trustees of the New York State Public Policy Institute and is a member of the Council on Foreign Relations. He is a former member of the Board of Governors of the American Stock Exchange and the National Association of Securities Dealers. Mr. Groves is former Chairman of the Board of Directors of the American Institute of Certified Public Accountants. He is a member and former Chair of the Board of Directors of The Ohio State University Foundation and a member of the Dean's Advisory Council of the Fisher College of Business. He is a former member of the Board of Overseers of The Wharton School, University of Pennsylvania and served as the Chairman of its Center for the Study of the Service Sector. Mr. Groves is a managing director, a member of the executive committee and Secretary-Treasurer of the Metropolitan Opera Association. Mr. Groves received a B.S. degree from The Ohio State University.
Lawrence L. Horsch joined the Company as a Director in February 1995. Previously, he had been Chairman of the Board of SCIMED Life Systems, Inc. from 1977 to 1994, director from 1977 to 1995 and Acting Chief Financial Officer from 1994 to 1995. Since 1990, Mr. Horsch has served as Chairman of Eagle Management & Financial Corp., a management consulting firm. He was Chairman and Chief Executive Officer of Munsingwear, Inc., from 1987 to 1990. Mr. Horsch also serves on several private company boards. Mr. Horsch received a B.A. degree from the University of St. Thomas and an M.B.A. degree from Northwestern University.
Paul A. LaViolette joined the Company as President, Boston Scientific International, and Vice President--International in January 1994. In February 1995, Mr. LaViolette was elected to the position of Senior Vice President and Group President--Nonvascular Businesses. In October 1998, Mr. LaViolette was appointed President, Boston Scientific International, and in February 2000 assumed responsibility for the Company's Scimed, EPT and Target businesses as Group President, Cardiovascular. In March, 2001, he also assumed the position of President, SCIMED.
Prior to joining the Company, he was employed by C.R. Bard, Inc. in various capacities, including President, U.S.C.I. Division, from July 1993 to November 1993, President, U.S.C.I. Angioplasty Division, from January 1993 to July 1993, Vice President and General Manager, U.S.C.I. Angioplasty Division, from August 1991 to January 1993, and Vice President U.S.C.I. Division, from January 1990 to August 1991. Mr. LaViolette received his B.A. degree from Fairfield University and an M.B.A. degree from Boston College.
Robert G. MacLean joined the Company as Senior Vice President--Human Resources in April 1996. Prior to joining the Company, he was Vice President--Worldwide Human Resources for National Semiconductor Corporation in Santa Clara, California from October 1992 to March 1996. Mr. MacLean has held various human resources management positions in the U.S. and Europe during his career. Prior to his business endeavors, he was Economics Professor at the University of the Pacific. Mr. MacLean received his B.A. and M.A. degrees and completed his doctoral studies in economics from Stanford University.
Ernest Mario became a Director of the Company in October 2001. Dr. Mario is currently the Chairman of IntraBiotics Pharmaceuticals, Inc., a pharmaceutical development company, and has served as a senior executive of a number of major international companies. From 1993 to 1997, Dr. Mario served as Co-Chairman and Chief Executive Officer of ALZA Corporation, a research-based pharmaceutical company with leading drug-delivery technologies, and Chairman and Chief Executive Officer from 1997 to 2001. Dr. Mario presently serves on the Boards of Directors of Catalytica Energy Systems, Inc., Maxygen, Inc., Orchid Biosciences, Inc., Pharmaceutical Product Development, Inc. and SonoSite, Inc. He is also a Trustee of Duke University and Chairman of the Board of the Duke University Health System. He is the Chairman of the American Foundation for Pharmaceutical Education and serves as an advisor to the colleges of pharmacy at the University of Maryland, the University of Rhode Island and Rutgers University. Dr. Mario holds a B.S. in Pharmacy from Rutgers, and an M.S. and a Ph.D. in Physical Sciences from the University of Rhode Island.
Stephen F. Moreci was appointed to the Executive Committee of the Company as Senior Vice President and Group President, Endosurgery in December 2000. Mr. Moreci joined the Company in 1989 and most recently served as the Company's President of its Medi-tech division since 1999. From 1989 until 1999, Mr. Moreci held a variety of management positions within the Company, including Vice President and General Manager of Cardiac Assist from 1989 to 1991, Vice President and General Manager of Microvasive Endoscopy from 1991 until 1995, Group Vice President of Nonvascular from 1995 until 1996 and President of Microvasive Endoscopy from 1996 until 1999. Mr. Moreci received a B.S. degree from Pennsylvania State University.
N.J. Nicholas, Jr. joined the Company as a Director in October 1994. Mr. Nicholas served as President of Time, Inc. from September 1986 to May 1990 and Co-Chief Executive Officer of Time Warner, Inc. from May 1990 until February 1992. N.J. Nicholas, Jr. is a director of Xerox Corporation and Priceline.com. Mr. Nicholas received an A.B. degree from Princeton University and an M.B.A. degree from Harvard Business School. He is also the brother of Peter M. Nicholas, Chairman of the Board of the Company.
Peter M. Nicholas, a co-founder of the Company, has been the Chairman of the Board of the Company since 1995. He has been a Director since 1979 and served as the Chief Executive Officer from 1979 to March 1999 and Co-Chairman of the Board from 1979 to 1995. Prior to joining the Company, he was corporate director of marketing and general manager of the Medical Products Division at Millipore Corporation, a medical device company, and served in various sales, marketing and general management positions at Eli Lilly and Company. He is currently Vice Chairman of the Board of Trustees of Duke University and a member of the Board's Executive Committee. Mr. Nicholas is also a member of the American Academy of Achievement and has recently received the Phoenix Lifetime Achievement Award. He is also a recent recipient of the Ellis Island Medal of Honor, and is a Fellow of the American Academy of Arts and Sciences. He is a member of the Massachusetts Business Roundtable and currently serves on the boards of the Boys & Girls Club of Boston, Massachusetts High Technology Council, and CEO's for Charter Schools. Mr. Nicholas also serves on several for profit and not-for-profit boards. After college, Mr. Nicholas served as an officer in the U.S. Navy, resigning his commission as lieutenant in 1966. Mr. Nicholas received a B.A. degree from Duke University, and an M.B.A. degree from The Wharton School of the University of Pennsylvania. He is also the brother of N.J. Nicholas, Jr., a Director of the Company.
Dennis A. Ocwieja was appointed to the Executive Committee of the Company as Senior Vice President - Regulatory Affairs on February 25, 2003. Mr. Ocwieja joined the Company in February 2000 as Vice President of Corporate Quality. In February 2002, his role was expanded to Vice President, Corporate Quality and Regulatory Affairs. From 1995 until 2000, Mr. Ocwieja was an independent consultant to several Fortune 100 companies in the medical product industry. He also served as Vice President, Quality and Regulatory Affairs for the Clintec Nutrition Company from 1993 until 1995 and Vice President, Quality and Regulatory Affairs for Arjo-Century from 1992 through 1993. From 1968 until 1992 Mr. Ocwieja held a variety of positions at Baxter Healthcare in Product Development, Product Service, Corporate Documentation and Quality/Regulatory. Mr. Ocwieja received a Bachelor of Science in Biology from Roosevelt University.
John E. Pepper is Chairman of the Executive Committee of the Board of Directors of The Procter & Gamble Company where has served in various capacities since 1963, including Chairman from 2000 to 2002, Chief Executive Officer and Chairman of the Board from 1995 to 1999, President from 1986 to 1995 and director since 1984. Mr. Pepper is a member of the Board of Directors of Xerox Corporation and Motorola Inc. and served as a member of the Board of Directors of the Company from November 1999 until May 2001. Mr. Pepper is a Fellow of The Yale Corporation and a Trustee of the Christ Church Endowment Fund. He serves on the boards of Partnership for a Drug Free America and the National Advisory Board of the National Underground Railroad Freedom Center. Mr. Pepper graduated from Yale University in 1960 and holds honorary doctorate degrees from Ohio State University, Xavier University, Mount St. Joseph College and St. Petersburg University (Russia).
Uwe E. Reinhardt, Ph.D. became a Director in 2002. Dr. Reinhardt is the James Madison Professor of Political Economy and Professor of Economics and Public Affairs at Princeton University, where he has taught since 1968. Dr. Reinhardt is a senior associate of the University of Cambridge, England and Trustee of Duke University, the Duke University Health System, H&Q Healthcare Investors and H&Q Life Sciences Investors. He also serves on the Boards of Directors of the Amerigroup Corporation and Triad Hospital, Inc. Dr. Reinhardt is a member of the National Advisory Council (NAC) for Health Care Policy, Research and Evaluation for the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Dr. Reinhardt received a Bachelor of Commerce degree from the University of Saskatchewan, Canada and a Ph.D. in economics from Yale University.
Senator Warren B. Rudman joined the Company as a Director in October 1999. Senator Rudman became a partner in the international law firm Paul, Weiss, Rifkind, Wharton, and Garrison in
1992 after serving two terms as a U.S. Senator from New Hampshire from 1980 to 1992. As of January 1, 2003, he became Of Counsel to Paul, Weiss, Rifkin, Wharton & Garrison LLP. Senator Rudman serves on the Boards of Trustees of the Brookings Institution, and the Council on Foreign Relations. He also serves on the boards of Allied Waste Industries, Inc., The Chubb Corporation, Collins & Aikman Corporation, Raytheon Corporation and several funds managed by the Dreyfus Corporation. He is also the founding co-chairman of the Concord Coalition. Senator Rudman received a B.S. from Syracuse University and a LL.B. from Boston College Law School and served in the U.S. Army during the Korean War.
Paul W. Sandman joined the Company as Senior Vice President, Secretary and General Counsel in May 1993. From March 1992 through April 1993, he was Senior Vice President, General Counsel and Secretary of Wang Laboratories, Inc., where he was responsible for legal affairs. From 1984 to 1992, Mr. Sandman was Vice President and Corporate Counsel of Wang Laboratories, Inc., where he was responsible for corporate and international legal affairs. Mr. Sandman received his A.B. from Boston College, and his J.D. from Harvard Law School.
James H. Taylor, Jr. joined the Company as Senior Vice President of Corporate Operations in August 1999. Mr. Taylor most recently served as Vice President of Global Technology at Nestle Clinical Nutrition from 1995 to 1997. Prior to joining Nestle, he completed a thirty-year career at Baxter International, where he held a broad range of positions in operations management, including from 1992 to 1995, the position of Corporate Vice President of Manufacturing Operations and Strategy. Mr. Taylor received his B.A. degree from the University of North Carolina.
James R. Tobin joined the Company as Director, President and Chief Executive Officer in March 1999. Prior to joining the Company, Mr. Tobin served as President and Chief Executive Officer of Biogen, Inc. from 1997 to 1998 and Chief Operating Officer of Biogen from 1994 to 1997. From 1972 to 1994, Mr. Tobin served in a variety of executive positions with Baxter International, including President and Chief Operating Officer from 1992 to 1994. Previously, he served at Baxter as Managing Director in Japan, Managing Director in Spain, President of Baxter's I.V. Systems Group and Executive Vice President. Mr. Tobin currently serves on the Boards of Directors of Beth Israel Deaconess Medical Center, the Carl J. Shapiro Institute for Education and Research, Curis, Inc., Osiris, Inc. and Applera Corporation (formerly PE Corporation). Mr. Tobin holds an A.B. from Harvard College and an M.B.A. from Harvard Business School. Mr. Tobin also served as a lieutenant in the U.S. Navy from 1968 to 1972.
PART II
ITEM 5. MARKET FOR THE COMPANY'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The Company's common stock is traded on the New York Stock Exchange under the symbol "BSX".
The information set forth under the caption "Market for the Company's Common Stock and Related Matters" included in the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) is incorporated herein by reference.
The closing price of the Company's Common Stock on March 21, 2003 was $47.40
ITEM 6. SELECTED FINANCIAL DATA
The information set forth under the caption "Five-Year Selected Financial Data" included in the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) is incorporated herein by reference.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The statements and information set forth under the caption "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) are incorporated herein by reference.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information set forth under the subcaption "Market Risk Disclosures" contained under the caption "Management's Discussion and Analysis of Financial Condition and Results of Operations" included on page 14 of the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) is incorporated herein by reference.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The consolidated financial statements of the Company and its subsidiaries included in the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) are incorporated herein by reference. The statements and information set forth under the caption "Quarterly Results of Operations" included in the Company's 2002 Consolidated Financial Statements (Exhibit 13.1 filed herewith) are incorporated herein by reference.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE COMPANY
The required information concerning directors and executive officers set forth in the Company's definitive Proxy Statement to be filed with the Commission on or about April 4, 2003 is incorporated herein by reference. See also "Directors and Executive Officers of the Company" following Item 4 herein.
ITEM 11. EXECUTIVE COMPENSATION
The required information concerning executive compensation set forth in the Company's definitive Proxy Statement to be filed with the Commission on or about April 4, 2003 is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The required statements concerning security ownership of certain beneficial owners and management and related stockholder matters set forth in the Company's definitive Proxy Statement to be filed with the Commission on or about April 4, 2003 are incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The required statements concerning certain relationships and related transactions set forth in the Company's definitive Proxy Statement to be filed with the Commission on or about April 4, 2003 are incorporated herein by reference.
ITEM 14. CONTROLS AND PROCEDURES
Evaluation of disclosure controls and procedures
Within 90 days prior to the date of this report (the Evaluation Date), the Company carried out an evaluation, under the supervision of its President and Chief Executive Officer and Senior Vice President - Finance & Administration and Chief Financial Officer, of the effectiveness of the design and operation of the Company's disclosure controls and procedures. Based on this evaluation, the Company's President and Chief Executive Officer and Senior Vice President - Finance & Administration and Chief Financial Officer concluded that as of the Evaluation Date, the Company's disclosure controls and procedures are effective in ensuring that material information relating to the Company required to be included in the Company's periodic filings with the Securities and Exchange Commission was made known to them on a timely basis. It should be noted that any system of controls is designed to provide reasonable, but not absolute, assurances that the system will achieve its stated goals under all potential circumstances.
Changes in internal controls
There were no significant changes in the Company's internal controls, or to the Company's knowledge, in other factors that could significantly affect the Company's disclosure controls and procedures subsequent to the Evaluation Date.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM
8-K
(a)(1) Financial Statements.
The response to this portion of Item 15 is set forth under Item 8.
(a)(2) Financial Schedules.
The response to this portion of Item 15 is filed herewith as a separate attachment to this report.
(a)(3) Exhibits (* documents filed herewith).
EXHIBIT NO. TITLE -- ----- 3.1 Second Restated Certificate of Incorporation of the Company (Exhibit 3.1, Annual Report on Form 10-K for the year ended December 31, 1993, File No. 1-11083). 3.2 Certificate of Amendment of the Second Restated Certificate of Incorporation of the Registrant (Exhibit 3.2, Annual Report on Form 10-K for the year ended December 31, 1994, File No. 1-11083). 3.3 Certificate of Second Amendment of the Second Restated Certificate of Incorporation of the Registrant (Exhibit 3.3, Annual Report on Form 10-K for the year ended December 31, 1998, File No. 1-11083). 3.4 Restated By-laws of the Company (Exhibit 3.2, Registration No. 33-46980). 4.1 Specimen Certificate for shares of the Company's Common Stock (Exhibit 4.1, Registration No. 33-46980). 4.2 Description of Capital Stock contained in Exhibits 3.1, 3.2, 3.3 and 3.4. 4.3 Form of Debt Securities Indenture (Exhibit 4.4, Registration Statement on Form S-3 of the Company, BSC Capital Trust, BSC Capital Trust II and BSC Capital Trust III, Registration No. 333-64887). 4.4 Form of First Supplemental Indenture dated as of December 6, 2001 (Exhibit 4.4, Annual Report on Form 10-K for the year ended December 31, 2002, File No. 1-110830). 4.5 6.625% Promissory Notes due March 15, 2005 issued by the Company in the aggregate principal amount of $500 million, each dated as of March 10, 1998 (Exhibit Nos. 4.1, 4.2 and 4.3 to the Company's Current Report on Form 8-K dated March 30, 1998, File No. 1-11083). 10.1 Form of Credit Agreement among the Company, The Several Lenders and Banc of America Securities LLC dated as of August 15, 2001 (Exhibit 10.2, Quarterly Report on Form 10-Q for |
EXHIBIT NO. TITLE -- ----- the quarter ended September 30, 2001, File No. 1-11083). 10.2 Form of Credit Agreement among the Company and The Several Lenders dated as of May 31, 2002 (Exhibit 10.1, Quarterly Report on Form 10-Q for the quarter ended June 30, 2002, File No. 1-11083). 10.3 Form of Credit and Security Agreement dated as of August 16, 2002 among Boston Scientific Funding Corporation, the Company, Blue Ridge Asset Funding Corporation, Victory Receivables Corporation The Bank of Tokyo-Mitsubishi Ltd., New York Branch and Wachovia Bank, N.A. (Exhibit 10.1, Quarterly Report on Form 10-Q for the quarter ended September 30, 2002, File No. 1-11083). 10.4 Form of Receivables Sale Agreement dated as of August 16, 2002 between the Company and each of its Direct or Indirect Wholly-Owned Subsidiaries that Hereafter Becomes a Seller Hereunder, as the Sellers, and Boston Scientific Funding Corporation, as the Buyer (Exhibit 10.2, Quarterly Report on Form 10-Q for the quarter ended September 30, 2002, File No. 1-11083). *10.6 License Agreement among Angiotech Pharmaceuticals, Inc., Cook Incorporated and the Company dated July 9, 1997, and related Agreement dated December 13, 1999. 10.7 Agreement Containing Consent Decree, dated as of February 23, 1995, between the Company and the Federal Trade Commission (Exhibit 10.16, Annual Report on Form 10-K for the year ended December 31, 1994, File No. 1-11083). 10.8 Letter Agreement, dated June 22, 1992, between the Company and Lawrence C. Best (Exhibit 10.11, Annual Report on Form 10-K for the year ended December 31, 1993, File No. 1-11083). 10.9 Letter Agreement dated March 17, 1999, between the Company and James R. Tobin (Exhibit 10.34, Annual Report on Form 10-K for the year ended December 31, 1998, File No. 1-11083). 10.10 Form of Indemnification Agreement between the Company and certain Directors and Officers (Exhibit 10.16, Registration No. 33-46980). 10.11 Form of Retention Agreement between the Company and certain Executive Officers (Exhibit 10.23, Annual Report on Form 10-K for the year ended December 31, 1996, File No. 1-11083). *10.12 Boston Scientific Corporation 401(k) Retirement Savings Plan, as Amended and Restated, Effective January 1, 2001, and amended as of January 1, 2003. 10.13 Boston Scientific Corporation Global Employee Stock Ownership Plan, as Amended and Restated (Exhibit 10.18, Annual Report on Form 10-K for the year ended December 31, 1997, |
EXHIBIT NO. TITLE -- ----- Exhibit 10.21, Annual Report on Form 10-K for the year ended December 31, 2000, Exhibit 10.22, Annual Report on Form 10-K for the year ended December 31, 2000, File No. 1-11083). 10.14 Boston Scientific Corporation Deferred Compensation Plan, Effective January 1, 1996 (Exhibit 10.17, Annual Report on Form 10-K for the year ended December 31, 1996, File No. 11083). 10.15 Boston Scientific Corporation 1992 Non-Employee Directors' Stock Option Plan, as amended (Exhibit 10.2, Annual Report on Form 10-K for the year ended December 31, 1996, Exhibit 10.3, Annual Report on Form 10-K for the year ended December 31, 2000, File No. 1-11083). 10.16 Boston Scientific Corporation 2000 Long Term Incentive Plan (Exhibit 10.20, Annual Report on Form 10-K for the year ended December 31, 1999, Exhibit 10.18, Annual Report on Form 10-K for the year ended December 31, 2001, File No. 1-11083). 10.17 Boston Scientific Corporation 1995 Long-Term Incentive Plan, as amended (Exhibit 10.1, Annual Report on Form 10-K for the year ended December 31, 1996, Exhibit 10.5, Annual Report on Form 10-K for the year ended December 31, 2001, File No. 1-11083) 10.18 Boston Scientific Corporation 1992 Long-Term Incentive Plan, as amended (Exhibit 10.1, Annual Report on Form 10-K for the year ended December 31, 1996, Exhibit 10.2, Annual Report on Form 10-K for the year ended December 31, 2001, File No. 1-11083). 10.19 SCIMED Life Systems, Inc. 1991 Directors Stock Option Plan, as amended (Exhibit 4.2, Registration No. 33-89772 which was incorporated by reference to Exhibit A to SCIMED's Proxy Statement dated June 8, 1994 for its 1994 Annual Meeting of Shareholders, Commission File No. 0-9301). 10.20 SCIMED Life Systems, Inc. 1992 Stock Option Plan (Exhibit 4.1, Registration No. 33-89772 which was incorporated by reference to Exhibit A to SCIMED's Proxy Statement dated May 26, 1992 for its 1992 Annual Meeting of Shareholders, Commission File No. 0-9301). 10.21 Heart Technology, Inc. Restated 1989 Stock Option Plan (Exhibit 4.5, Registration No. 33-99766 which was incorporated by reference to Exhibit 10.4 to the Registration Statement on Form S-1 of Heart Technology, Registration No. 33-45203). 10.22 EP Technologies, Inc. 1991 Stock Option/Stock Issuance Plan (Exhibit 4.6, Registration No. 33-80265 which was incorporated by reference to EPT's Registration Statement on Form S-8, File No. 33-82140). 10.23 EP Technologies, Inc. 1993 Stock Option/Stock Issuance Plan, (Exhibit 4.5, Registration No. 33-80265 which was incorporated by reference to EPT's Registration Statement on Form S-8, Registration No. 33-93196). 10.24 Target Therapeutics, Inc. 1988 Stock Option Plan (Exhibit 10.2, Quarterly Report of Target Therapeutics, Inc. on Form 10-Q for the quarter ended September 30, 1996, File No. 0-19801). |
EXHIBIT NO. TITLE -- ----- 10.25 Target Therapeutics, Inc. 1988 Stock Option Plan, (Exhibit 10.3 Quarterly Report of Target Therapeutics, Inc. on Form 10-Q for the quarter ended September 30, 1996, File No. 0-19801). 10.26 Embolic Protection Incorporated 1999 Stock Plan (Exhibit 10.1, Registration Statement on Form S-8 of the Company, Registration No. 333-61060). 10.27 Quanam Medical Corporation 1996 Equity Incentive Plan (Exhibit 10.2, Registration Statement on Form S-8 of the Company, Registration No. 333-61060). 10.28 Quanam Medical Corporation 1996 Stock Plan (Exhibit 10.3, Registration Statement on Form S-8 of the Company, Registration No. 333-61060). 10.29 RadioTherapeutics Corporation 1994 Stock Incentive Plan (Exhibit 10.1, Registration Statement on Form S-8 of the Company, Registration No. 333-76380). 11 Statement regarding computation of per share earnings (included in Note O to the Company's 2002 Consolidated Financial Statements for the year ended December 31, 2002, filed as Exhibit 13.1 hereto). *12.1 Statement regarding computation of ratios of earnings to fixed charges. *13.1 The Company's 2002 Consolidated Financial Statements for the year ended December 31, 2002. 13.2 Report of Independent Auditors, Ernst & Young LLP (included in the Company's 2002 Consolidated Financial Statements for the year ended December 31, 2002, filed as Exhibit 13.1 hereto). *21.1 List of the Company's subsidiaries as of March 21, 2003. *23.1 Consent of Independent Auditors, Ernst & Young LLP. *99.1 Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *99.2 Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (b) Reports on Form 8-K. None. |
SIGNATURE
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: March 31, 2003 BOSTON SCIENTIFIC CORPORATION By: /s/ Lawrence C. Best ---------------------------------- Lawrence C. Best Chief Financial Officer |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Company and in the capacities and on the dates indicated.
Dated: March 31, 2003 /s/ John E. Abele -------------------------------------- John E. Abele Director, Founder Dated: March 31, 2003 /s/ Lawrence C. Best -------------------------------------- Lawrence C. Best Senior Vice President--Finance and Administration and Chief Financial Officer (Principal Financial and Accounting Officer) Dated: March 31, 2003 /s/ Ursula M. Burns -------------------------------------- Ursula M. Burns Director Dated: March 31, 2003 /s/ Joseph A. Ciffolillo -------------------------------------- Joseph A. Ciffolillo Director Dated: March 31, 2003 /s/ Joel L. Fleishman -------------------------------------- Joel L. Fleishman Director |
Dated: March 31, 2003 /s/ Marye Anne Fox -------------------------------------- Marye Anne Fox Director Dated: March 31, 2003 /s/ Ray J. Groves -------------------------------------- Ray J. Groves Director Dated: March 31, 2003 /s/ Lawrence L. Horsch -------------------------------------- Lawrence L. Horsch Director Dated: March 31, 2003 /s/ Ernest Mario -------------------------------------- Ernest Mario Director Dated: March 31, 2003 /s/ N.J. Nicholas, Jr. -------------------------------------- N.J. Nicholas, Jr. Director Dated: March 31, 2003 /s/ Peter M. Nicholas -------------------------------------- Peter M. Nicholas Director, Chairman of the Board Dated: March 31, 2003 /s/ Uwe E. Reinhardt, Ph.D. -------------------------------------- Uwe E. Reinhardt, Ph.D. Director Dated: March 31, 2003 /s/ Warren B. Rudman -------------------------------------- Warren B. Rudman Director Dated: March 31, 2003 /s/ James R. Tobin -------------------------------------- James R. Tobin Director, President and Chief Executive Officer (Principal Executive Officer) |
CERTIFICATIONS
I, James R. Tobin, certify that:
1. I have reviewed this annual report on Form 10-K of Boston Scientific Corporation;
2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the "Evaluation Date"); and
c) presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and
6. The registrant's other certifying officers and I have indicated in this annual report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: March 31, 2003 /s/ James R. Tobin _______________________ James R. Tobin Chief Executive Officer |
CERTIFICATIONS
I, Lawrence C. Best, certify that:
1. I have reviewed this annual report on Form 10-K of Boston Scientific Corporation;
2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report;
3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report;
4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this annual report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this annual report (the "Evaluation Date"); and
c) presented in this annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;
5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and
6. The registrant's other certifying officers and I have indicated in this annual report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: March 31, 2003 /s/ Lawrence C. Best _______________________ Lawrence C. Best Chief Financial Officer |
SCHEDULE II
VALUATION AND QUALIFYING ACCOUNTS
Charges to Balance at Charges to (Deductions from) Balance at Beginning Costs and Other End of Description of Period Expenses Deductions Accounts Period ----------- --------- -------- ---------- -------- ------ (In millions) YEAR ENDED DECEMBER 31, 2002 Reserves and allowances deducted from asset accounts: Allowances for uncollectible amounts and sales returns and allowances $62 3 6(a) (1)(b) $58 YEAR ENDED DECEMBER 31, 2001 Reserves and allowances deducted from asset accounts: Allowances for uncollectible amounts and sales returns and allowances $67 9 7(a) (7)(b) $62 YEAR ENDED DECEMBER 31, 2000 Reserves and allowances deducted from asset accounts: Allowances for uncollectible amounts and sales returns and allowances $63 8 9(a) 5(b) $67 |
(b) Charges for sales returns and allowances, net of actual sales returns
Certain prior years' amounts have been reclassified to conform to the current year's presentation.
Exhibit 10.6
LICENSE AGREEMENT
This License Agreement, dated as of July 9, 1997, is by and among Angiotech Pharmaceuticals, Inc., a corporation organized under the laws of the Province of British Columbia ("Angiotech"); Boston Scientific Corporation, a Delaware corporation ("BSC"); and Cook Incorporated, an Indiana corporation ("Cook").
WITNESSETH
WHEREAS, Angiotech owns certain domestic and foreign patents and patent applications and has acquired licenses to other domestic and foreign parents and patent applications relating to the use of paclitaxel as a coating for certain medical devices;
WHEREAS, Angiotech has also developed and owns certain products and technology in the area of the use of paclitaxel as a coating for certain medical devices;
WHEREAS, Angiotech has the right to grant licenses with respect to such patents, patent applications, products and technology for use in specified areas; and
WHEREAS, each of BSC and Cook desires to receive a co-exclusive license, subject only to the grant of such a license to the other party, for the use of such patents, patent applications, products and technology for the duration of the United States and foreign patents covering such products and technology for certain applications in the fields of vascular and alimentary tract and liver applications, and Angiotech is willing to grant such a license to each of BSC and Cook.
NOW, THEREFORE, in consideration of the mutual promises and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Angiotech, BSC and Cook hereby agree as follows:
1. DEFINITIONS
Capitalized terms used in this Agreement and not otherwise defined herein shall have the meaning as set forth below:
"Affiliate" means any entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with a party to this Agreement. For purposes of this definition, control means the direct or indirect ownership of at least fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction), of (a) the outstanding voting securities of such entity, or (b) the decision making authority of such entity.
"Agreement" means this License Agreement, together with all exhibits annexed hereto, as the same shall be modified and in effect from time to time.
"Allowable Fees" has the meaning set forth in Section 8.7.
"Angiotech" shall have the meaning set forth in the Preamble to this Agreement.
"Angiotech Technology" shall mean (a) the Patent Rights, license rights and existing technology set forth on Exhibit A hereto, (b) any New Angiotech Technology which Cook or BSC, as the case may be, elects to have included in the Angiotech Technology pursuant to Section 2.3, (c) any and all improvements to the foregoing developed by Angiotech, or, subject to limitations and restrictions on Angiotech's rights to technology licensed from third parties, for Angiotech, during the term of this Agreement (including those arising under the CRADA to the extent solely owned by Angiotech), and (d) Technical Information that is useful or necessary to practice the foregoing.
"Base Unit Number" shall be calculated for each of BSC and Cook and their respective Affiliates in each Geographical Area at such times as BSC or Cook or their respective Affiliates, as the case may be, makes its first commercial sale of an Eligible Stent Product in such Geographical Area for a vascular application (each, a "Calculation Date") and shall mean, with respect to BSC or Cook, as the case may be, the number of units of Stent Products sold for vascular applications by BSC or Cook, as the case may be, to non-Affiliates in such Geographical Area during the last Contract Quarter ending prior to the applicable Calculation Date.
"BSC" has the meaning set forth in the preamble to this Agreement.
"BSC Endoluminal Royalty" has the meaning set forth in Section 3.2(c).
"BSC GI Sales Royalty" has the meaning set forth in Section 3.2(b).
"BSC IDE Approval Date" has the meaning set forth Section 3.1(b)(i).
"BSC IDE Filing Date" has the meaning set forth in Section 3.1(a).
"BSC License" shall have the meaning set forth in Section 2.1(a).
"BSC Milestone License Fees" has the meaning set forth in Section 3.1.
"BSC PMA Filing Date" has the meaning set forth in Section 3.1(b).
"BSC Royalty Payments" has the meaning set forth in Section 3.2 and includes royalties under Section 3.3.
"BSC Sales Milestone License Fee" has the meaning set forth in Section 3.1(c).
"BSC Vascular Sales Royalty" has the meaning set forth in Section 3.2(a).
"Confidential Information" means all information and data provided by the parties, to each other hereunder in written or other tangible medium and marked as confidential, or if
disclosed orally or displayed, confirmed in writing as confidential within thirty (30) days after disclosure, except any portion thereof which:
(a) is known to the receiving party, as evidenced by the receiving party's written records, before receipt thereof under this Agreement;
(b) is disclosed to the receiving party by a third person who is under no obligation of confidentially to the disclosing party hereunder with respect to such information and who otherwise has a right to make such disclosure;
(c) is or becomes generally known in the trade through no fault of the receiving party;
(d) is independently developed by the receiving party, as evidenced by the receiving party's written records, without access to such information; or
(e) is required to be disclosed by applicable statute, rule or regulation of any court or regulatory authority with competent jurisdiction; provided, that the party whose information is to be disclosed shall be notified as soon as possible and the party that is being required to disclose such information shall, if requested by the party whose information is to be disclosed, use reasonable good faith efforts, at the expense of the requesting party, to assist in seeking a protective order (or equivalent) with respect to such disclosure or otherwise take reasonable steps to avoid making such disclosure.
"Contract Quarter" means a calendar quarter or any part thereof.
"Contract Year" shall mean each successive period of four consecutive Contract Quarters, with the first such Contract Year beginning on the first day of the first full Contract Quarter beginning after the date hereof.
"Cook" has the meaning set forth in the Preamble to this Agreement.
"Cook Endoluminal Royalty" has the meaning set forth in Section 4.2(c).
"Cook GI Sales Royalty" has the meaning set forth in Section 4.2(b).
"Cook IDE Approval Date" has the meaning set forth in Section 4.1(b)(i).
"Cook IDE Filing Date" has the meaning set forth in Section 4.1(a).
"Cook License" shall have the meaning set forth in Section 2.1(b).
"Cook Milestone License Fees" has the meaning set forth in Section 4.1.
"Cook PMA Filing Date" has the meaning set forth in Section 4.1(b).
"Cook Royalty Payments" has the meaning set forth in Section 4.2 and includes royalties under Section 4.3.
"Cook Sales Milestone License Fee" has the meaning set forth in Section 4.1(c).
"Cook Vascular Sales Royalty" has the meaning set forth in Section 4.2(a).
"CRADA" has the meaning set forth in Section 6.1.
"Eligible Endoluminal Products" means any Endoluminal Products that incorporate Angiotech Technology and are sold by BSC, Cook or their Affiliates, respectively, provided, however, that "Eligible Endoluminal Products" shall not include any Eligible Stent Products.
"Eligible Products" means Eligible Stent Products and Eligible Endoluminal Products.
"Eligible Stent Products" means any Stent Products that incorporate Angiotech Technology and are sold by BSC, Cook or their Affiliates, respectively; provided, however, that "Eligible Stent Products" shall not include any Eligible Endoluminal Products.
"Endoluminal Products" means endoluminal drug delivery devices, including stent grafts and stent-like devices, as well as balloons and other endoluminal delivery systems used for drug delivery, but excluding vascular grafts and Stent Products.
"Entity" means any corporation, association, partnership (general or limited), joint venture, trust, estate, limited liability company, limited liability partnership or other legal entity or organization.
"FDA" means the United States Food and Drug Administration.
"Geographical Areas" means the five areas of the world comprised of the
(a) United States, (b) the countries of the European Union, as comprised on the
date of this Agreement, (c) Japan, (d) Canada, and (e) the remaining countries
of the world, respectively.
"GI" means the alimentary tract and liver.
"Investment Documentation" means that certain Investment Agreement between Angiotech, BSC and Cook and related documents, each dated as of the date of this Agreement, pursuant to which BSC and Cook shall each agree to purchase, and Angiotech shall agree to sell to each of BSC and Cook, 190,042 Class C Preference shares of Angiotech's capital stock for the purchase price, and subject to the terms and conditions, specified therein.
"Licensed Application" shall means the use of Angiotech Technology in the Licensed Field of Use on or incorporated in Stent Products and Endoluminal Products, but specifically excluding systemic treatments and pastes, micropheres, films, sprays and similar formulations in circumstances where such are not applied to or incorporated in either a Stent Product or an Endoluminal Product, as the case may be.
"Licensed Field of Use" means endoluminal vascular and GI applications.
"Licenses" has the meaning set forth in Section 7.2(d).
"Net Sales" means gross sales from the sale, rent, lease or otherwise
making available to third parties of Eligible Products, less the fol1owing, to
the extent the same are credited or deducted from the invoiced amount:
discounts, refunds, replacement or credits allowed to purchasers for return of
Eligible Products or as reimbursement for damaged Eligible Products, freight,
postage, insurance, and other shipping charges, sales and use taxes, customs
duties, and any other governmental tax or charge (except income taxes) imposed
on or at the time of the production, importation, use, or sale of Eligible
Products (if separately invoiced), including any value added taxes (VAT), as
adjusted for rebates and refunds, and transfers at or below cost by or on behalf
of BSC or Cook of Eligible Products or the practice of the Angiotech Technology
in connection with compassionate use, emergency use, bona fide research,
treatment, Investigational New Drug Applications (IND's) or the like authorized
by the FDA or corresponding foreign agencies, provided, however, that in the
case of an Eligible Product sold by BSC or Cook in combination with one or more
Non-Stent Products (collectively, a "Combination Product"), Net Sales shall
exclude the Value (as defined below) of any Non-Stent Products included in the
Combination Product (e.g., where a Stent Product is combined with a balloon for
delivery). No deductions shall be made for commissions paid to individuals,
whether they be with independent agencies or regularly employed by BSC, Cook,
their Affiliates and on their respective payrolls, or for the cost of
col1ections. "Value," for purposes of this subparagraph, shall mean fair market
value, as determined by the commercial sales price of the Non-Stent Product(s)
sold separately, or, if not sold separately, the fair market value of such
Non-Stent Product(s) reasonably determined by BSC or Cook, as the case may be,
with notice of such fair market value to be given to Angiotech together with the
basis upon which such determination was made. If Angiotech does not agree with
the fair market value determined by BSC or Cook, as the case may be, Angiotech
may submit the matter to arbitration in accordance with Section 10.2. The
calculation of Net Sales of Combination Products will be subject to the audit
rights set forth in Section 6.4(b).
"New Angiotech Technology" has the meaning set forth in Section 2.3(a).
"NIH" has the meaning set forth in Section 6.1.
"NIH Agreement" has the meaning set forth in Section 6.1.
"NIH License" means the licenses granted to Angiotech and its sublicensees under the NIH Agreement.
"NIH Patent Rights" means the intellectual property rights covered under the NIH Agreement.
"NIH Royalty" shall mean the percentage of Net Sales required to be paid to the NIH under the NIH Agreement with respect to sales of Eligible Products by BSC or Cook, as the case may be, in a Particular country.
"Non-Licensed Products" has the meaning set forth in Section 8.11.
"Non-Stent Product" means all Products of BSC and Cook other than Endoluminal Products and Stent Products.
"Patent Rights" means all of the following intellectual property or other rights of Angiotech:
(a) all United States and foreign patents, patent applications and provisional applications concerning the Angiotech Technology listed on Exhibit A hereto; including without limitation the patents owned or filed by, or licensed to, Angiotech listed on Exhibit A hereto; and
(b) all United States and foreign patents issued with respect to the applications identified in clause (a) hereof including divisionals, continuations, re-examinations and re-issues of such applications or patents.
"Remaining Licensee" has the meaning set forth in Section 9.3.
"Stent Products" means stents.
"Technical Information" means all know-how, data and other proprietary information in the possession of or developed or acquired by Angiotech during the term of this Agreement that directly relates to the Patent Rights, license rights and technology set forth on Exhibit A hereto or otherwise relates to the use of chemotherapeutic or anti-angiogenic compounds or is necessary or useful to practice the licenses set forth in Section 2.1(a) or 2.l(b), as the case may be.
"Technology Transfer" means delivery of all Angiotech Technology to BSC and Cook, including all applicable documentation related thereto, including but not limited to the documentation and procedures specified in Exhibit B annexed hereto.
2. LICENSES
2.1 Grants. Subject to the terms and conditions hereof, the following licenses are granted hereby, each effective as of the date of this Agreement:
(a) BSC Technology License. In consideration for the execution, delivery and performance of the Investment Documentation and the assumption by BSC of its payment and other obligations hereunder and subject to all the other terms and conditions of this license, Angiotech hereby grants to BSC an exclusive (subject only to the rights granted to Cook and reserved to Angiotech in paragraphs (b) and (c) below and the reservations in favor of the NIH, the United States Government and third parties specified under the NIH Agreement), worldwide
right and license to use, manufacture, have manufactured, distribute and sell, and to grant sublicenses to its Affiliates to use, manufacture, have manufactured, distribute and sell, the Angiotech Technology in the Licensed Field of Use solely for use in the Licensed Applications (the "BSC License").
(b) Cook Technology License. In consideration for the execution, delivery and performance of the Investment Documentation and the assumption by Cook of its payment and other obligations hereunder and subject to all the other terms and conditions of this license, Angiotech hereby grants to Cook an exclusive (subject only to the rights granted to BSC and reserved to Angiotech pursuant to paragraphs (a) above and (c) below and the reservations in favor of the NIH, the United States Government and third parties under the NIH Agreement) worldwide right and license to use, manufacture, have manufactured, distribute and sell, and to grant sublicenses to its Affiliates to use, manufacture, have manufactured, distribute and sell, the Angiotech Technology in the Licensed Field of Use solely for use in the Licensed Applications (the "Cook License").
(c) Reservation of Rights. Angiotech reserves all rights to the Angiotech Technology for (i) any use or purpose outside the Licensed Field of Use and Licenced Applications and (ii) noncommercial research purposes in all fields and applications, including the Licensed Field of Use and Licensed Applications.
2.2 Duration and Term. The BSC License, the Cook License and this Agreement shall each, subject to the early termination provisions of Sections 5.1, 5.2 and 9.1, have a term from the date hereof until the last expiration date of any United States or foreign patents included in the Angiotech Technology (including any United States or foreign patents which become part of the Angiotech Technology after the date of this Agreement), provided, however, that the terms of Sections 6.4(b) and (c), 8.3 through 8.6 (but only with respect to rights or obligations that arise prior to the termination of this Agreement), 8.9, 9.2, 9.3, 10 and 11 shall survive the expiration or termination of the Agreement or any licenses granted hereunder.
2.3 New Inventions or License Rights. Subject to the rights of third parties that may exist at any time and from time to time, Angiotech hereby grants to each of BSC and Cook, jointly or individually, a right to elect to include in the BSC License (in the event that BSC so elects), and in the Cook License (in the event that Cook so elects), (a) as "Angiotech Technology," any new inventions and developments, and (b) as "Patent Rights," any patents and patent applications, all of the foregoing which are made by, or for, or licensed to, Angiotech (including those arising from the CRADA), to the extent such new inventions, developments, patents and patent applications relate to the patents, patent applications, license rights and other technology described on Exhibit A hereto or may be used in the Licensed Field of Use (other than Angiotech Technology) ("New Angiotech Technology"). Angiotech shall notify BSC and Cook in writing of such inventions and developments, providing a description of the technology and any financial and other obligations under any applicable third party license, and each of BSC and Cook may, by giving written notice to Angiotech at any time during the BSC License and Cook License elect to include the New Angiotech Technology as Angiotech Technology or
Patent Rights, whichever is applicable, under this Agreement (to the extent an election is made, the " Electing Parties"); provided, that an Electing Party will be obligated to reimburse Angiotech for all of the costs and expenses of Angiotech under any third party license (apportioned between BSC and Cook by agreement between BSC and Cook, if both parties elect, and by Angiotech, acting reasonably, notice of such apportionment to be given to BSC and Cook together with the basis upon which the apportionment determination was made, between the uses authorized in this Agreement and uses outside the scope of this Agreement, subject to the right of BSC or Cook to review the determination and submit the determination to arbitration pursuant to Section 10.2) and will be obligated to pay royalties on sales as required by any third party license in addition to the royalties payable under this Agreement. In addition, an Electing Party will be subject to all performance, minimum sales and other obligations set forth in the third party license (or apportioned by Angiotech) relating to such New Angiotech Technology. Notwithstanding the foregoing, Angiotech shall be free to license the New Angiotech Technology to third parties outside the Licensed Applications and the Licensed Field of Use. Notwithstanding the foregoing, in no event shall any failure by BSC or Cook to elect to include any New Angiotech Technology in the Angiotech Technology pursuant to this Section 2.3 be deemed to grant any right to Angiotech to use, manufacture, have manufactured, distribute or sell, or grant any license to any third party to do any of the same, any Angiotech Technology in the Licensed Field of Use for use in any Licensed Applications.
3. BSC ROYALTIES & FEES
3.1 BSC Milestone License Fees. In consideration for the license granted under Section 2.1 (a) of this Agreement, BSC shall pay the following amounts to Angiotech as license fees at the times, and subject to the conditions, set forth below (col1ectively, the "BSC Milestone License Fees"):
(a) BSC IDE Fee. Within twenty (20) business days after the date of the first filing by BSC of an Investigational Device Exemption with the FDA or an equivalent filing with an appropriate governmental agency in one or more European countries with respect to a product of BSC incorporating or utilizing the Angiotech Technology in a vascular application (the "BSC IDE Filing Date"), BSC shall pay a license fee calculated as follows:
(i) if the BSC IDE Filing Date is on or after October 15, 1998, the amount of $1,275,000; or
(ii) if the BSC IDE Filing Date is prior to October 15, 1998, the amount of (x) $1,275,000 minus (y) the product of $125,000 for each complete thirty (30) day period by which the BSC IDE Filing Date precedes October 15, 1998; provided, however, that in no event shall any fee calculated pursuant to this Section 3.1(a)(ii) be less than $525,000.
(b) BSC PMA Fee. Within twenty (20) business days after
the date of the first filing by BSC of a Pre-Market Approval Application or
Section 510(k) Pre-Marketing Notification with the FDA, or an equivalent filing
with an appropriate governmental agency in Europe, with respect to a product of
BSC incorporating or utilizing the Angiotech Technology in
a vascular application (the "BSC PMA Filing"), BSC shall pay an additional license fee calculated as follows:
(i) subject to Section 3.1(b)(iii) below, if the date of the BSC PMA Filing is on or after the twenty-four month anniversary of the date on which the FDA (or appropriate governmental agency in Europe) approves the applicable IDE or equivalent European filing filed by BSC (the "BSC IDE Approval Date"), the amount of $2,050,000; or
(ii) if the date of the BSC PMA Filing is prior
to the twenty-four month anniversary of the BSC IDE Approval Date, the amount of
(x) $2,050,000,minus (y) the product of $200,000 for each complete thirty (30)
day period by which the date of the BSC PMA Filing precedes the twenty-four
month anniversary of the BSC IDE Approval Date, provided, however, that in no
event shall any fee calculated pursuant to this Section 3.1(b)(ii) be less than
$800,000; or
(iii) if, and to the extent, prior to the date of the BSC PMA Filing, the FDA requires clinical follow-up in excess of nine (9) months and BSC is unable to make the BSC PMA Filing prior to expiration of the "twenty-four (24) month" period referenced in Section 3.2(b)(ii) above, the amount of (x) $2,050,000, minus (y) the product of $100,000 for each complete thirty (30) day period by which the date of the BSC PMA Filing precedes the Extended BSC PMA Filing Date, provided, however, that in no event shall any fee calculated pursuant to this Section 3.1(b)(iii) be less than $800,000. For purposes of this paragraph, "Extended BSC PMA Filing Date" means the date which is twenty-four (24) months following the BSC IDE Approval Date plus the number of months the FDA requires clinical follow-up in excess of nine (9) months.
(c) BSC Milestone License Fee. Within twenty (20) business days after the end of the first Contract Quarter in which the Net Sales by BSC of Eligible Stent Products for such Contract Quarter and the immediately preceding Contract Quarter together exceed $5,000,000, BSC shall pay Angiotech an additional license fee (the "BSC Sales Milestone License Fee") equal to the difference of (x) $4,500,000 minus (y) one-half of the amount of any BSC Royalty Payments paid by BSC pursuant to Section 3.2 prior to or on the date on which the BSC Sales Milestone License Fee is actually paid.
3.2 BSC Royalties. As additional consideration for the license granted under Section 2.1(a) of the Agreement BSC shall pay the following royalties to Angiotech (collectively, the "BSC Royalty Payments").
(a) Vascular Sales Royalty on Eligible Stent Products. Within sixty (60) days after the end of each Contract Quarter during the term of the BSC License, BSC shall pay Angiotech a royalty (the "BSC Vascular Sales Royalty") on Net Sales of Eligible Stent Products that are covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights, by BSC and its Affiliates during such Contract Quarter for vascular applications in each of the Geographical Areas, calculated as the sum of the following:
(i) with respect to sales during a Contract Quarter of units of Eligible Stent Products covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights for vascular applications from zero to the product of the Base Unit Number for such Eligible Stent Products for such Geographical Area multiplied by 1.25, the royalty shall be an amount equal to five percent (5%) of the Net Sales of such units of Eligible Stent Products;
(ii) with respect to sales during a Contract
Quarter of units of Eligible Stent Products covered in the country of sale by
one or more valid and enforceable claims included in the Patent Rights for
vascular applications from (x) the product of the Base Unit Number for such
Eligible Stent Products for such Geographical Area multiplied by 1.25, to (y)
the product of the Base Units Number of such Eligible Stent Products for such
Geographical Area multiplied by two, the royalty shall be an amount equal to
seven percent (7%) of the Net Sales of such units of Eligible Stent Products:
and
(iii) with respect to sales during a Contract Quarter of units of Eligible Stent Products covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights for vascular applications above the product of the Base Unit Number for such Eligible Stent Products for such Geographical Area multiplied by two, the royalty shall be an amount equal to ten (l0%) percent of the Net Sales of such units of Eligible Stent Products, provided, however, that from and after the date on which the aggregate amount of BSC Royalty Payments made by BSC pursuant to this Section 3.2(a)(iii) during the term of the BSC License exceed $100,000,000, any further royalties payable under this Section 3.2(a)(iii) shall be calculated as an amount equal to eight percent (8%) of the Net Sales of such Eligible Stent Products.
(iv) by way of example but not limitation, Exhibit E sets forth an example of calculating BSC Royalty Payments based on the Base Unit Number.
(b) GI Sales Royalty on Eligible Stent Products. Within sixty (60) days after the end of each Contract Quarter during the term of the BSC License, BSC shall pay Angiotech an additional royalty (the "BSC GI Sales Royalty") on Net Sales of Eligible Stent Products that are covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights, by BSC and its Affiliates during such Contract Quarter for GI applications in each of the Geographical Areas, calculated as five percent (5%) of the Net Sales of such Eligible Stent Products.
(c) Royalties on Eligible Endoluminal Products. Within sixty (60) days after the end of each Contract Quarter during the term of the BSC License, BSC shall pay Angiotech an additional royalty (the "BSC Endoluminal Royalty") on Net Sales of Eligible Endoluminal Products that are covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights, by BSC and its Affiliates during such Contract Quarter in each of the Geographical Areas, calculated as five percent (5%) of the Net Sales of such Eligible Endoluminal Products.
(d) Royalties in Japan. Notwithstanding anything contrary in this Agreement, for purposes of determining whether a particular Eligible Product is covered in Japan by one or more valid and enforceable claims included in the Patent Rights for purposes of Sections 3.2(a), (b) and (c), such Product shall be deemed to be covered in Japan by one or more valid and enforceable claims included in the Patent Rights if (i) the particular Eligible Product is covered by a valid and enforceable claim of a patent included in the Patent Rights which has been issued in Japan, or (ii) the particular Eligible Product is covered by a claim of a pending patent application in Japan, and BSC has "de facto exclusivity" (as defined in Section 3.3(a) below) in Japan with respect to that Eligible Product.
3.3 Patent Coverage and De Facto Exclusivity
(a) De Facto Exclusivity Defined. BSC shall be deemed to
have "de facto exclusivity" for a particular Eligible Product in a particular
country unless a third party (other than Cook or an Affiliate of BSC or Cook)
(i) has obtained approval for sale (if required) in that country for a product
which is competitive to a particular Eligible Product in that country and (ii)
has made at least one commercial sale for value of that product in that country
within six (6) months prior to or after the Contract Quarter in which the
royalty calculation is being made, provided, however, that BSC shall not be
deemed to have "de facto exclusivity" in a particular country to the extent that
such "de facto exclusivity" is primarily attributable to patent rights (other
than the Patent Rights) owned by, or licensed to, BSC.
(b) Patent Coverage Defined. BSC shall be deemed to have "Patent Coverage" for a particular Eligible Product in a country if there is a valid claim that, but for the licenses granted to BSC under this Agreement, would be infringed by the manufacture, use or sale of such Eligible Product in such country or by the manufacture of such Eligible Product in the country of manufacture.
(c) De Facto Royalty. For countries in which there is no Patent Coverage, if at any time BSC does have de facto exclusivity for a particular Eligible Product in a particular country, then BSC shall pay Angiotech a royalty on its Net Sales of that Eligible Product in that country of three percent (3%) during such period of de facto exclusivity, which payments shall also constitute BSC Royalty Payments. If, during the term of the BSC License, BSC does not have de facto exclusivity for a particular Eligible Product in a particular country and there is no Patent Coverage for such Eligible Product in that country, but an NIH Royalty is still payable by Angiotech for Net Sales by BSC of such Eligible Product in such country, BSC shall be responsible for the payment of such NIH Royalty during such period(s).
3.4 Reduction of BSC Royalties. After the BSC Sales Milestone License Fee has been paid, BSC shall be entitled to reduce the amount of any BSC Royalty Payments that may become payable with respect to any Contract Quarter by an amount equal to one-half of the aggregate amount of such payment (calculated without regard to any other possible reductions in such fees pursuant to the terms of this Agreement) until the aggregate amount of the reductions made to the BSC Royalty Payments pursuant to this Section 3.4 equal the amount of
the BSC Sales Milestone License fee actually paid and not already offset by BSC Royalty Payments pursuant to Section 3.1(c), after which time no further reductions will be made.
3.5 Sales to Affiliates. On sales of Eligible Products by BSC to its Affiliates, or on sales made in other than an arm's-length transaction, the value of the Net Sales attributed under this Section 3 to such a transaction shall be that which would have been received in an arm's-length transaction. Notwithstanding the foregoing, sales between and among BSC and its Affiliates that are intended for resale shall not be included in Net Sales.
3.6 Reporting of BSC Royalties. BSC shall deliver to Angiotech within sixty (60) days after the end of each Contract Quarter during the term of the BSC License, a written account, including quantities, of the aggregate of BSC's and its Affiliates' sales subject to royalty payments hereunder and the amount of the royalty payment due to Angiotech for such Contract Quarter. Each royalty report shall be certified as correct by an authorized employee of BSC and shall include a reasonably detailed listing of all deductions made to determine Net Sales and to calculate the royalties payable hereunder.
3.7 Payment of BSC Milestone License Fees and BSC Royalties. BSC Milestone License Fees and BSC Royalties due under this Section 3 shall be paid in U.S. dollars. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the conversion rate used by BSC to convert the applicable sales into U.S. dollars for purposes of the preparation of BSC's consolidated financial statements, such conversion to be calculated in accordance with generally accepted accounting principles in the United States, applied consistently. All payments shall be made by wire transfer to Angiotech's account in accordance with the following instructions:
Chase Manahattan Bank
New York, NY
ABM# 021000021
For credit to the account of:
Angiotech Pharmaceuticals, Inc.
Account #401-217-5
Branch #7400
Institution #003
Royal Bank of Canada - Pender & Bute Branch
1205 West Pender Street
Vancouver, B.C. V6E 2V5
Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by BSC. The royalty report required by Section 3.6 shall accompany each such payment.
3.8 Late Payments. Late charges will be assessed by Angiotech as additional royalties on any overdue payments at one percent (1%) per month, compounded monthly (an
effective annual rate of twelve and 68/100 percent (12.68%) per annum). The payment of such late charges will not prevent Angiotech from exercising any other rights it may have as a consequence of the lateness of any payment.
3.9 Governmental Filings. Except for taxes based on Angiotech's income, BSC will be solely responsible for determining if any tax on Net Sales and royalty payments is owed to any governmental authority and shall pay any such tax and be responsible for all filings with appropriate governmental authorities.
3.10 Estimation of Net Sales. In the event that BSC is unable to report and pay royalties due under this Section 3 on actual Net Sales in any Contract Quarter. BSC will make a good faith estimate of Net Sales for those jurisdictions in which actual Net Sales information is not readily available and will make Royalty Payments based on such estimate. When actual Net Sales information becomes available for those jurisidictions for which estimates had previously been made, BSC will promptly determine, and give notice to Angiotech of, the appropriate adjustment necessary to reconcile the estimated Royalty Payment with the actual Royalty Payment due to Angiotech based on actual Net Sales (each a "Reconciliation"). The next Royalty Payment due Angiotech from BSC under this Agreement will include an adjustment to reflect such Reconciliation, or the amount of such Reconciliation will be paid in cash if no further royalties are anticipated.
4. COOK ROYALTIES & FEES
4.1 Cook Milestone License Fees. In consideration for the license granted under Section 2.1(b) of this Agreement, Cook shall pay the following amounts to Angiotech as license fees at the times, and subject to the conditions, set forth below (collectively, the "Cook Milestone License Fees"):
(a) Cook IDE Fee. Within twenty (20) business days after the date of the first filing by Cook of an Investigational Device Exemption with the FDA or an equivalent filing with an appropriate governmental agency in one or more European countries with respect to a product of Cook incorporating or utilizing the Angiotech Technology in a vascular application (the "Cook IDE Filing Date"), Cook shall pay a license fee calculated as follows:
(i) if the Cook IDE Filing Date is on or after October 15, 1998, the amount of $1,275,000; or
(ii) if the Cook IDE Filing Date is prior to October 15, 1998, the amount of (x) $1,275,000 minus (y) the product of $125,000 for each complete thirty (30) day period by which the Cook IDE Filing Date precedes October 15, 1998; provided, however, that in no event shall any fee calculated pursuant to this Section 4.1(a)(ii) be less than $525,000.
(b) Cook PMA Fee. Within twenty (20) business days after
the date of the first filing by Cook of a Pre-Market Approval Application or
Section 510(k) Pre-Marketing Notification with the FDA, or an equivalent filing
with an appropriate governmental agency in
Europe, with respect to a product of Cook incorporating or utilizing the Angiotech Technology in a vascular application (the "Cook PMA Filing"), Cook shall pay an additional license fee calculated as follows:
(i) subject to Section 4.1(b)(iii) below, if the date of the Cook PMA Filing is on or after the twenty-four (24) month anniversary of the date on which the FDA (or appropriate governmental agency in Europe) approves the applicable IDE or equivalent European filing filed by Cook (the "Cook IDE Approval Date"), the amount of $2,050,000; or
(ii) if the date of the Cook PMA Filing is prior to the twenty-four (24) month anniversary of the Cook IDE Approval Date, the amount of (x) $2,050,000, minus (y) the product of $200,000 for each complete thirty (30) day period by which the date of the Cook PMA Filing precedes the twenty-four month anniversary of the Cook IDE Approval Date, Provided, however, that in no event shall any fee calculated pursuant to this Section 4.1(b)(ii) be less than $800,000; or
(iii) if, and to the extent, prior to the date of the Cook PMA Filing, the FDA requires clinical follow-up in excess of nine (9) months and Cook is unable to make the Cook PMA Filing prior to expiration of the "twenty-four (24) month" period referenced in Section 4.2(b)(ii) above, the amount of (x) $2,050,000, minus (y) the product of $100,000 for each complete thirty (30) day period by which the date of the Cook PMA Filing precedes the Extended Cook PMA Filing Date, provided, however, that in no event shall any fee calculated pursuant to this Section 4.1(b)(iii) be less than $800,000. For purposes of this paragraph, "Extended Cook PMA Filing Date" means the date which is twenty-four (24) months following the Cook IDE Approval Date plus the number of months the FDA requires clinical follow-up in excess of nine (9) months.
(c) Cook Sales Milestone License Fee. Within twenty (20) business days after the end of the first Contract Quarter in which the Net Sales by Cook of Eligible Stent Products for such Contract Quarter and the immediately preceding Contract Quarter together exceed $5,000,000, Cook shall pay Angiotech an additional license fee (the "Cook Sales Milestone License Fee") equal to the difference of (x) $4,500,000 minus (y) one-half of the amount of any Cook Royalty Payments paid by Cook pursuant to Section 4.2 prior to or on the date on which the Cook Sales Milestone License Fee is actually paid.
4.2 Cook Royalties. As additional consideration for the license granted under Section 2.1(a) of the Agreement, Cook shall pay the following royalties to Angiotech (collectively, the "Cook Royalty Payments").
(a) Vascular Sales Royalty on Eligible Stent Products. Within sixty (60) days after the end of each Contract Quarter during the term of the Cook License, Cook shall pay Angiotech a royalty (the "Cook Vascular Sales Royalty") on Net Sales of Eligible Stent Products that are covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights, by Cook and its Affiliates during such Contract Quarter for vascular applications in each of the Geographical Areas, calculated as the sum of the following:
(i) with respect to sales during a Contract Quarter of units of Eligible Stent Products covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights for vascular applications from zero to the product of the Base Unit Number for such Eligible Stent Products for such Geographical Area multiplied by 1.25, the royalty shall be an amount equal to five percent (5%) of the Net Sales of such units of Eligible Stent Products:
(ii) with respect to sales during a Contract Quarter of units of Eligible Stent Products covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights for vascular applications from (x) the product of the Base Unit Number for such Eligible Stent Products for such Geographical Area multiplied by 1.25, to (y) the product of the Base Unit Number of such Eligible Stent Products for such Geographical Area multiplied by two, the royalty shall be an amount equal to seven percent (7%) of the Net Sales of such units of Eligible Stent Products; and
(iii) with respect to sales during a Contract Quarter of units of Eligible Stent Products covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights for vascular applications above the product of the Base Unit Number for such Eligible Stent Products for such Geographical Area multiplied by two, the royalty shall be an amount equal to ten (10%) percent of the Net Sales of such units of Eligible Stent Products, provided, however, that from and after the date on which the aggregate amount of Cook Royalty Payments made by Cook pursuant to this Section 4.2(a)(iii) during the term of the Cook License exceed $100,000,000, any further royalties payable under this Section 4.2(a)(iii) shall be calculated as an amount equal to eight percent (8%) of the Net Sales of such Eligible Stent Products.
(iv) by way of example but not limitation, Exhibit E sets forth an example of calculating Cook Royalty Payments based on the Base Unit Number.
(b) GI Sales Royalty on Eligible Stent Products. Within sixty (60) days after the end of each Contract Quarter during the term of the Cook License, Cook shall pay Angiotech an additional royalty (the "Cook GI Sales Royalty") on Net Sales of Eligible Stent Products that are covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights, by Cook and its Affiliates during such Contract Quarter for GI applications in each of the Geographical Areas, calculated as five percent (5%) of the Net Sales of such Eligible Stent Products.
(c) Royalties on Eligible Endoluminal Products. Within sixty (60) days after the end of each Contract Quarter during the term of the Cook License, Cook shall pay Angiotech an additional royalty (the "Cook Endoluminal Royalty") on Net Sales of Eligible Endoluminal Products that are covered in the country of sale by one or more valid and enforceable claims included in the Patent Rights, by Cook and its Affiliates during such Contract Quarter in each of the Geographical Areas, calculated as five percent (5%) of the Net Sales of such Eligible Endoluminal Products.
(d) Royalties in Japan. Notwithstanding anything contrary in this Agreement, for purposes of determining whether a particular Eligible Product is covered in Japan by one or more valid and enforceable claims included in the Patent Rights for purposes of Sections 4.2(a), (b) and (c), such Product shall be deemed to be covered in Japan by one or more valid and enforceable claims included in the Patent Rights if (i) the particular Eligible Product is covered by a valid and enforceable claim of a patent included in the Patent Rights which has been issued in Japan, or (ii) the particular Eligible Product is covered by a claim of a pending patent application in Japan, and Cook has "de facto exclusivity" (as defined in Section 4.3(a) below) in Japan with respect to that Eligible Product.
4.3 Patent Coverage and De Facto Exclusivity
(a) De Facto. Exclusivity Defined. Cook shall be deemed to have "de facto exclusivity" for a particular Eligible Product in a particular country unless a third party (other than BSC or an Affiliate of BSC or Cook) (i) has obtained approval for sale (if required) in that country for a product which is competitive to a particular Eligible Product in that country and (ii) has made at least one commercial sale for value of that product in that country within six (6) months prior to or after the Contract Quarter in which the royalty calculation is being made, provided, however, that Cook shall not be deemed to have "de facto exclusivity" in a particular country to the extent that such "de facto exclusivity" is primarily attributable to patent rights (other than the Patent Rights) owned by, or licensed to, Cook.
(b) Patent Coverage Defined. Cook shall be deemed to have "Patent Coverage" for a particular Eligible Product in a country if there is valid claim that, but for the licenses granted to Cook under this Agreement, would be infringed by the manufacture, use or sale of such Eligible Product in such country or by the manufacture of such Eligible Product in the country of manufacture.
(c) De Facto Royalty. For countries in which there is no Patent Coverage, if at any time Cook does have de facto exclusivity for a particular Eligible Product in a particular country, then Cook shall pay Angiotech a royalty on its Net Sales of that Eligible Product in that country of three percent (3%) during such period of de facto exclusivity, which payments shall also constitute Cook Royalty Payments. If, during the term of the Cook License, Cook does not have de facto exclusivity for a particular Eligible Product in a particular country and there is no Patent Coverage for such Eligible Product in that country, but an NIH Royalty is still payable by Angiotech for Net Sales by Cook of such Eligible Product in such country, Cook shall be responsible for the payment of such NIH Royalty during such period(s).
4.4 Reduction of Cook Royalties. After the Cook Sales Milestone License Fee has been paid, Cook shall be entitled to reduce the amount of any Cook Royalty Payments that may become payable with respect to any Contract Quarter by an amount equal to one-half of the aggregate amount of such payment (calculated without regard to any other possible reductions in such fees pursuant to the terms of this Agreement) until the aggregate amount of the reductions made to the Cook Royalty Payments pursuant to this Section 4.4 equal the amount of
the Cook Sales Milestone License Fee actually paid and not already offset by Cook Royalty Payments pursuant to Section 4.1(c), after which time no further reductions will be made.
4.5 Sales to Affiliates. On sales of Eligible Products by Cook to its Affiliates, or on sales made in other than an arm's-length transaction, the value of the Net Sales attributed under this Section 4 to such a transaction shall be that which would have been received in an arm's-length transaction. Notwithstanding the foregoing, sales between and among Cook, its Affiliates that are intended for resale shall not be included in Net Sales.
4.6 Reporting of Cook Royalties. Cook shall deliver to Angiotech within sixty (60) days after the end of each Contract Quarter during the term of the Cook License, a written account, including quantities, of the aggregate of Cook's and its Affiliates' sales subject to royalty payments hereunder and the amount of the royalty payment due to Angiotech for such Contract Quarter. Each royalty report shall be certified as correct by an authorized employee of Cook and shall include a detailed listing of all deductions made to determine Net Sales and to ca1culate the royalties payable hereunder.
4.7 Payment of Cook Milestone License Fees and Cook Royalties. Cook Milestone License Fees and Cook Royalties due under this Section 4 shall be paid in U.S. dollars. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the conversion rate used by Cook to convert the applicable sales into U.S. dollars for purposes of the preparation of Cook's consolidated income statements, such conversion to be calculated in accordance with generally accepted accounting principles in the United States, applied consistently. All payments shall be made by wire transfer to Angiotech's account in accordance with the following instructions:
Chase Manahattan Bank
New York, NY
ABM# 021000021
For credit to the account of:
Angiotech Pharmaceuticals, Inc.
Account #401-217-5
Branch #7400
Institution #003
Royal Bank of Canada - Pender & Bute Branch
1205 West Pender Street
Vancouver, B.C. V6E 2V5
Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by Cook. The royalty report required by Section 4.6 shall accompany each such payment.
4.8 Late Payments. Late charges will be assessed by Angiotech as additional royalties on any overdue payments at one percent (1%) per month, compounded monthly (an
effective annual rate of twelve and 68/100 percent (12.68%) per annum). The payment of such late charges will not prevent Angiotech from exercising any other rights it may have as a consequence of the lateness of any payment.
4.9 Governmental Filings. Except for taxes based on Angiotech's income. Cook will be solely responsible for determining if any tax on Net Sales and royalty payments is owed to any governmental authority and shall pay any such tax and be responsible for all filings with appropriate governmental authorities.
4.10 Estimation of Net Sales. In the event that Cook is unable to report and pay royalties due under this Section 4 on actual Net Sales in any Contract Quarter, Cook will make a good faith estimate of Net Sales for those jurisdictions in which actual Net Sales information is not readily available and will make Royalty Payments based on such estimate. When actual Net Sales information becomes available for those jurisdictions for which estimates had previously been made, Cook will promptly determine, and give notice to Angiotech of, the appropriate adjustment necessary to reconcile the estimated Royalty Payment with the actual Royalty Payment due to Angiotech based on actual Net Sales (each a "Reconciliation"). The next Royalty Payment due Angiotech from Cook under this Agreement will include an adjustment to reflect such Reconciliation, or the amount of such Reconciliation will be paid in cash if no further royalties are anticipated.
5. TERMINATIONS AND AMENDMENTS RELATING TO ANGIOTECH TECHNOLOGY
5.1 Termination by BSC -- Vascular Paclitaxel-Based Technology. In
the event that BSC reasonably determines that the use of the paclitaxel-based
technology contained in the Angiotech Technology with vascular Stent Products is
not commercially viable, BSC shall have the right, subject to giving written
notice to Angiotech setting forth in reasonable detail the basis for its
determination, to cause the BSC License, insofar as it relates to such
paclitaxel-based technology in the use of vascular Stent Products, to be
terminated. In the event of any such termination, (a) the BSC License, insofar
as it relates to the Angiotech Technology other than paclitaxel-based technology
in the Licensed Field of Use, shall remain in full force and effect, (b) the
amount of any BSC Milestone License Fees which may become due after the date on
which BSC gives Angiotech notice of its intent to terminate pursuant to this
Section 5.l, shall be reduced by fifty percent (50%) and (c) the minimum amounts
payable under Sections 6.2 and 6.3 shall terminate.
5.2 Termination by Cook -- Vascular Paclitaxel-Based Technology. In the event that Cook reasonably determines that the use of the paclitaxel-based technology contained in the Angiotech Technology with vascular Stent Products is not commercially viable, Cook shall have the right subject to giving written notice to Angiotech setting forth in reasonable detail the basis for its determination, to cause the Cook License, insofar as it relates to such paclitaxel-based technology in the use of vascular Stent Products, to be terminated. In the event of any such termination, (a) the Cook License, insofar as it relates to the Angiotech Technology other than paclitaxel-based technology in the Licensed Field of Use, shall remain in full force
and effect, (b) the amount of any Cook Milestone License Fees which may become due after the date on which Cook gives Angiotech notice of its intent to terminate pursuant to this Section 5.2, shall be reduced by fifty percent (50%) and (c) the minimum amounts payable under Sections 6.2 and 6.3 shall terminate.
5.3 Amendment to Include Additional NIH License Rights. The parties acknowledge that Angiotech intends to negotiate in good faith with the NIH for an exclusive license to the NIH Patents Rights for vascular applications (an "Exclusive License"). The parties anticipate that any Exclusive License may be conditioned upon Angiotech and its sublicensees assuming additional obligations, including performance milestones. The parties agree that if and when such Exclusive License is granted, they will negotiate in good faith amendments to this Agreement that are not inconsistent with the obligations and terms of such Exclusive License.
6. OTHER OBLIGATION OF BSC, COOK AND ANGIOTECH
6.1 CRADA Study. Angiotech covenants to pay the National Institutes of Health ("NIH") all amounts owed to NIH under the License Agreement dated as of November 26, 1996, between Angiotech and NIH relating to "Drug Delivery Systems and Methods of Treating Fibroproliterative Vascular Diseases using Microtubial Stabilizing Agents," a copy of which is attached hereto as Exhibit B (the "NIH Agreement") and all amounts owed to NIH under its cooperative research and development agreement with NIH (the "CRADA"). Each of BSC and Cook shall reimburse Angiotech, within thirty (30) days of receipt of an invoice therefor, for fifty percent (50%) of all direct expenditures made by Angiotech for research relevant to determining the effect of Eligible Products in the treatment of vascular disease under the CRADA, up to a maximum of $351,500 for each of BSC and Cook. In addition, if the research conducted under the CRADA is expanded at the request of BSC or Cook, BSC or Cook, as the case may be, will reimburse Angiotech for one hundred percent (100%) of any additional expenditures as a result thereof (with each of BSC and Cook reimbursing Angiotech for fifty percent (50%) of such cost if both parties so request, and solely if only one party so requests). Cook and BSC agree to provide a reasonable number of stents and other endoluminal devices necessary for the research to be conducted under the CRADA at no cost; provided, however, that BSC and Cook shall not be required to provide any stents or other endoluminal devices for any study protocols which they have not approved in advance in writing (such approval not to be untimely or unreasonably withheld).
6.2 Regulatory Approvals. Each of BSC and Cook shall be responsible for obtaining all regulatory approvals for their respective Eligible Products in all Geographical Areas which such parties, in their sole discretion, deem necessary or advisable, including funding all pre-clinical and clinical studies deemed by such parties to be necessary or advisable for obtaining regularly approvals, provided, however, that each of BSC and Cook agrees that during the term of their respective licenses granted under Sections 2.1(a) and 2.1(b) hereof, they will each commit to spend a minimum of $ 1,750 000 (including any amounts reimbursed to Angiotech pursuant to Section 6.1, and subject to reduction under Sections 5.1 and 5.2) on
clinical studies relating to products which may incorporate or utilize Angiotech Technology. Angiotech agrees to provide reasonable assistance upon request by BSC or Cook in the pursuit of regulatory approvals for products incorporating or utilizing Angiotech Technology; provided that BSC or Cook, as the case may be, reimburse Angiotech for its reasonable expenses of providing such assistance.
6.3 Market Launch. During the term of their respective licenses granted under Section 2.1, each of BSC and Cook agrees to commit a minimum of $1,000,000 in direct marketing and sales expenses for Eligible Products that incorporate Angiotech Technology (subject to reduction pursuant to Sections 5.1 and 5.2).
6.4 Reporting
(a) Progress Reports. BSC and Cook shall each provide written annual reports on their respective product development progress or efforts to commercialize the Angiotech Technology for each of the Licensed Applications and Licensed Fields of Use within forty-five (45) days after December 31 of each calendar year. These progress reports shall include, but not be limited to, progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing, marketing, and sales during the preceding calendar year, as well as plans for the present calendar year. BSC and Cook each agree to provide any additional information reasonably required by Angiotech to evaluate their respective performance under this Agreement and to allow Angiotech to fulfill its obligations under the NIH Agreement.
(b) Audit Rights. BSC and Cook shall each keep accurate records of all of their respective operations and of reports of operations by their Affiliates within the scope of this Agreement for five (5) years following a given reporting period, and Angiotech, at its expense, shall have the right, exercisable with respect to each of BSC and Cook no more frequently than once per Contract Year, to have a certified public accountant, reasonably acceptable to BSC or Cock, as the case may be, inspect such records at the offices of BSC or Cook, as applicable, no later than three (3) years after the end of the Contract Quarter to which they pertain upon two (2) weeks prior notice by Angiotech. Any such certified public accountant shall be required to agree in writing to be bound by reasonable confidentiality provisions with respect to such information prior to receiving access to such information. In the event the examination shows an underpayment of more than five percent (5%) for any Contract Year due to an error on the part of the record-keeping party, such party shall pay the examining party the amounts underpaid, together with interest pursuant to Section 3.8 or 4.8, as applicable, and the actual cost of such examination.
(c) NIH Reporting. BSC and Cook shall use their reasonable best efforts to assist Angiotech in fulfilling its reporting obligations under the NIH Agreement, including but not limited to notifying Angiotech of the date of First Commercial Sale (as defined in the NIH Agreement) in each country within sixty (60) days of such occurrence, and providing the information necessary to determine royalties due to NIH for Combined Products (as defined in
the NIH Agreement). BSC and Cook hereby consent to the delivery to NIH by Angiotech of any reports and information provided under this Agreement. Angiotech agrees to (i) only provide such information to NIH as is required by the NIH Agreement and (ii) take steps reasonably necessary under the NIH Agreement to protect the confidentiality of such information.
6.5 Patent Applications and Foreign Filing. Angiotech shall be entitled to fi1e, prosecute and maintain in force any and all patents and patent applications included in the Patent Rights (excluding the NIH Patent Rights which are governed by the NIH Agreement); provided, that with respect to the Angiotech Patent Rights, Angiotech will provide BSC and Cook a reasonable opportunity to review and comment on the same. The filing, prosecution and maintenance of patents and patent applications pursuant to this Section shall be done through patent counsel selected by Angiotech. Angiotech shall keep BSC and Cook reasonably informed of all office actions, proposed responses or other patent prosecution activities involving the Patent Rights.
6.6 Supply of Paclitaxel. If requested by either or both of BSC and Cook, Angiotech agrees to use commercially reasonable efforts to assist such party or parties in acquiring sufficient quantities of Paclitaxel to practice the Angiotech Technology under the license granted to such party or parties under Section 2.1.
7. REPRESENTATIONS AND COVENANTS
7.1 Mutual Representations. Angiotech, BSC and Cook each represent and warrant to the other parties that:
(a) Organization & Power. The party is a corporation duly organized and validly existing under the laws of its state of incorporation and has all requisite corporate power and authority to enter into this Agreement;
(b) Authorization. The party is duly authorized by all requisite action to execute, deliver and perform this Agreement and to consummate the transactions contemplated hereby, and that the same do not conflict or cause a default with respect to its obligations under any other agreement; and
(c) Execution & Delivery. The party has duly executed and delivered this Agreement.
7.2 Angiotech Technology Representations and Warranties. Angiotech represents and warrants to BSC and Cook that:
(a) Except as set forth on Exhibit A hereto, Angiotech is the sole and exclusive owner of the Angiotech Technology, including without limitation, the Patent Rights, free of any liens or encumbrances;
(b) Except as set forth on Exhibit A hereto, Angiotech has not received any notice from any person or Entity claiming to have any right, title or interest in or to the Angiotech Technology and, to Angiotech's knowledge, there is no reason to expect that any such notice is forthcoming; and
(c) Except as set forth on Exhibit A hereto, Angiotech has not entered into, and is not aware of, any outstanding options, licenses or agreements relating to the Angiotech Technology; and
(d) Each of the Patent Rights included in the Angiotech Technology which is listed on Exhibit A as being licensed to Angiotech is subject to a valid and enforceable license (the "Licenses"), except as such enforceability may be limited by (i) applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors' rights and (ii) general principles of equity that restrict the availability of equitable remedies. Neither Angiotech nor, to the knowledge of Angiotech, the other party to any of such Licenses is in material breach or violation of such License.
7.3 Covenants Regarding Licenses. Angiotech, BSC and Cook each hereby covenant and agree to take all commercially reasonable actions necessary to perform all of their respective obligations under the Licenses and remain in compliance with any conditions of such Licenses. Angiotech agrees to notify each of BSC and Cook in the event of any material breach of any of the Licenses. Upon receipt of such notice from Angiotech, and provided Angiotech has not commenced to cure, diligently pursued such cure and in fact cured such breach, within a reasonable time period, each of BSC and Cook shall be permitted, acting individually or in concert and upon prior written notice to Angiotech, to Cure any such breach on behalf of Angiotech and shall be permitted to recover the amount of any damages, losses or expenses (including any reasonable attorney's fees and expenses) incurred by such party in connection with curing such breach, or offset any such amounts against any obligations that such party shall have to pay to Angiotech hereunder.
7.4 Compliance with NIH License. BSC and Cook each hereby agree to comply with the covenants and conditions of the NIH Agreement set forth in Exhibit C hereto as if they were a party to the NIH Agreement. To the extent the NIH Agreement is amended to include additional terms and conditions, the parties agree to amend Exhibit C to include such terms and conditions as are relevant to the BSC License and Cook License; provided, that any such amendment to the NIH Agreement will not impair the rights of BSC or Cook under this Agreement; and provided further, that any such amendment to the NIH Agreement that imposes additional obligations on BSC or Cook, or may reduce the benefits to either of BSC or Cook of the NIH Agreement, will not be entered into without the prior written consent of BSC and Cook, which consent will not be untimely or unreasonably withheld.
7.5 Technical Assistance. Commencing promptly after the execution of this Agreement. Angiotech shall use reasonable best efforts to complete the Technology Transfer.
8. INFRINGEMENT AND OTHER PRODUCTS
8.1 Notification of Infringement. Each of BSC, Cook and Angiotech agrees to promptly notify the other parties hereto of any infringements of any rights contained within the Angiotech Technology in the Licensed Field of Use of which they become aware.
8.2 Action by Angiotech. Subject to Angiotech's obligations to NIH and any other third party licensors, Angiotech shall have in the first instance the right, in its sole discretion and at its expense, to prosecute any alleged infringements of the Angiotech Technology in its own name. Each of BSC and Cook agrees to allow Angiotech to include it, at the expense of Angiotech, as a plaintiff in any suit brought with respect to such infringement and Angiotech agrees to consult with counsel for BSC and Cook on any significant matters related to such litigation.
8.3 Actions by BSC or Cook. Subject to Angiotech's obligations to NIH and any other third party licensors, in the event that Angiotech, within one hundred twenty (120) days after being notified by BSC or Cook of any infringement of the Angiotech Technology in the Licensed Field of Use, shall have been unsuccessful in negotiating with the alleged infringer to cease and desist such infringement and shall not have brought an infringement action, or shall have notified BSC and Cook that it has determined not to bring an action against the alleged infringer, then, in those events, BSC and Cook shall have the right to bring an action against such infringer. Prior to instituting any such action, Cook and BSC shall consult with one another to agree upon a mutually acceptable strategy for pursuing such action. Angiotech agrees to allow each of BSC and Cook to include it, at the expense of the requesting party or parties, as a plaintiff in any suit brought with respect to any such infringement and each of BSC and Cook agree to consult with counsel for Angiotech on any significant matters relating to such litigation.
8.4 Damages. Any recovery of damages for each suit shall be
applied as follows: (a) first, to pay any amounts owed to NIH under the
corresponding infringement language in the NIH Agreement, (b) second, to the
party or parties bringing the action, to reimburse it or them for its or their
expenses of the litigation or suit, including reasonable attorneys' fees; (c)
third, to the other party or parties to reimburse it or them for its or their
expenses of the litigation or suit, including reasonable attorneys' fees; then
(d) fourth, twenty-five percent (25%) of the balance to Angiotech, then (e)
fifth, the remaining balance to each of BSC and Cook in amounts to be agreed
upon by BSC and Cook, giving appropriate weight to all relevant factors
including, but not limited to, historical and projected sales of products and
the relative market shares of BSC and Cook in the area or areas which are the
subject of such action, and the expenses of such parties incurred in pursuing
such action.
8.5 Disposition. No settlement, consent judgment or other voluntarily final disposition of any such action relating to an alleged infringement of the Angiotech Technology in the Licensed Field of Use may be entered into (a) without the consent of Angiotech, BSC and Cook, as applicable, if such party participates in the infringement action, which consent shall
not be unreasonably withheld by such party, and (b) without the Consent of NIH to the extent required under the NIH Agreement.
8.6 Cooperation. In any infringement suit, any party shall be entitled to request the cooperation and assistance of the other parties, at the requesting party's expense, as may be reasonably necessary for the suit. Each party agrees to make available relevant records, papers, information, samples and specimens, as well as to have its employees testify upon request.
8.7 Third Party Licenses. Angiotech represents that, to its
knowledge, except as set forth on Exhibit A, there are no third parties to whom
license fees must be paid to utilize the Angiotech Technology in a manner
contemplated by the licenses granted in Section 2.1 of this Agreement. If use of
the Angiotech Technology in a manner contemplated by the licenses granted in
Section 2.1 of this Agreement would infringe third party rights such that BSC or
Cook require a license from such third party to use the Angiotech Technology for
any of the Licensed Applications (provided that this Section 8.7 shall not apply
(i) to the extent BSC or Cook, or an Affiliate of either BSC or Cook, decide to
use an agent, drug delivery technology or composition that would require a third
party license, even though an alternative agent, drug delivery technology or
composition might be available, or developed, that would not require a third
party license or (ii) to New Inventions licensed from third parties under
Section 2.3, in which event the license with the third party will govern the
rights of BSC and Cook), then BSC or Cook may obtain a license from such third
party and shall be permitted to offset the total of any royalties or other
amounts paid thereunder (subject to the limitation set out in this Section 8.7)
against any BSC Royalty Payments or Cook Royalty Payments, unless the third
party is BSC or Cook or an Affiliate of the party obtaining the license
("Allowable Fees"). Fifty percent (50%) of Allowable Fees which become due to
such third parties by BSC or Cook shall be credited against any BSC Royalty
Payments or Cook Royalty Payments owed by BSC or Cook, as the case may be, to
Angiotech in respect of the applicable period when paid, provided, however,
that, subject to any recoveries, reductions or offsets made by BSC or Cook, as
the case may be, pursuant to other Sections of this Agreement, in no event shall
any BSC Royalty Payments or Cook Royalty Payments be reduced by virtue of this
Section 8.7 below the following amounts:
Minimum Royalty in Royalty: each Geographical Area: -------- ----------------------- BSC Vascular Sales Royalty 4% of Net Sales of Eligible Products BSC GI Sales Royalty 3% of Net Sales of Eligible Products Cook Vascular Sales Royalty 4% of Net Sales of Eligible Products Cook GI Sales Royalty 3% of Net Sales of Eligible Products BSC Endoluminal Royalty 3% of Net Sales of Eligible Products Cook Endoluminal Royalty 3% of Net Sales of Eligible Products |
For purposes of determining whether or not of the Angiotech Technology in a manner contemplated by the licenses granted in Section 2.1 of this Agreement would infringe third party
rights such that BSC or Cook will require a license from such third party to use the Angiotech Technology for any of the Licensed Applications, in the absence of determination by a court or pursuant to arbitration under Section 10.2, BSC, Cook or their Affiliates, as the case may be, shall be entitled to rely upon an infringement opinion from a law firm reasonably acceptable to Angiotech, which opinion shall be controlling for purposes of this Section 8.7.
8.8 Reduction Relating to Claims. In the event that BSC or Cook incurs or accrues any expenses in connection with any claim or objection of any third party that any of the Angiotech Technology infringes a patent or other right of such third party relating to the Angiotech Technology, or other intellectual property in which Angiotech has an ownership or licensee interest, whether or not BSC or Cook, as the case may be, is a party to such litigation. such party shall be entitled, from the date of such claim or objection until the claim or objection is resolved favorably to Angiotech, BSC or Cook, as the case may be, to reduce the amount of any payments in respect of royalties which may otherwise be due in accordance with the terms of Sections 3.1 and 3.2, in the case of BSC, or Sections 4.1 and 4.2, in the case of Cook (calculated without regard to any other possible reductions in such fees pursuant to the terms of this Agreement), by an amount equal to up to fifty percent (50%) of any such payment; provided, however, that, subject to any recoveries, reductions or offsets made by BSC or Cook, as the case may be, pursuant to other sections of this Agreement, in no event shall the royalty payments be reduced by virtue of this Section 8.8 below the minimum amounts set forth in Section 8.7 above.
8.9 Indemnification
(a) BSC and each of its Affiliates shall indemnify and hold Cook, its Affiliates and Angiotech and their respective officers, directors, employees, consultants, contractors and agents harmless from and against any and all liability, damage, loss, Cost (including reasonable attorneys' fees) and expense resulting from any claim of bodily injury or property damage (i) relating to the development, manufacture, use, distribution or sale of any Eligible Product by BSC, or its Affiliates, or (ii) due to the negligence or willful misconduct of BSC, its Affiliates, or their respective employees or agents.
(b) Cook and each of its Affiliates shall indemnify and hold BSC and its Affiliates, and Angiotech and their respective officers, directors, employees, consultants, contractors and agents harmless from and against any and all liability, damage, loss, cost (including reasonable attorneys' fees) and expense resulting from any claim of bodily injury or property damage (i) relating to the development, manufacture, use, distribution or sale of any Eligible Product by Cook or its Affiliates, or (ii) due to the negligence or willful misconduct of Cook, its Affiliates, or their respective employees or agents.
(c) Angiotech shall indemnify and hold BSC, Cook and their respective Affiliates, officers, directors, employees, consultants, contractors and agents harmless from and against any and all liability, damage, loss, cost (including reasonable attorneys' fees) and expense resulting from any claim of bodily injury or property damage (i) relating to the
development, manufacture, use, distribution or sale of any product by Angiotech
or its sublicensees (other than BSC, Cook or their respective Affiliates), or
(ii) due to the negligence or willful misconduct of Angiotech or its employees
or agents.
8.10 Insurance. BSC, Cook and each of their Affiliates shall procure and maintain, during the term of this Agreement, public liability, product liability and errors and omissions insurance in the minimum amounts, and with the insurance carriers (or other insurance carriers of comparable reputation and financial credibility), set forth on Exhibit D. BSC, Cock and each of their Affiliates will provide Angiotech with a certificate of insurance evidencing the insurance coverage required by this Section 8.10.
8.11 Strength of Patent Rights. In the event that, during the term
of any license granted Angiotech pursuant to this Agreement, one or more
products are marketed or sold by one or more Entities which are not Affiliates
of either of BSC or Cook, in one or more countries, that (a) employ delivery of
paclitaxel, or an analog or derivative thereof, on Stent Products in the
Licensed Field of Use that are competitive to the Eligible Products, (b) do not
infringe the Patent Rights, and (c) represent a market share of three percent
(3%) or more in such country or countries (collectively, "Non-License
Products"), then each of BSC, Cook or their respective Affiliates, as the case
may be, may either (i) upon written notice to Angiotech terminate the license
granted to such party with respect to such country or countries in which such
Non-License Products are marketed or sold, or (ii) give written notice of such
Non-License Products to Angiotech and all BSC Royalty Payments and Cook Royalty
Payments, as the case may be, due to Angiotech for such country or countries, on
and after notice to Angiotech of such Non-Licensed Products, shall be reduced to
a royalty rate equal to the NIH Royalty plus one percent (1%) of Net Sales of
Eligible Products (of any class) in such country or countries. For purposes of
determining whether or not the product or products infringe the Patent Rights,
in the absence of determination by a court or pursuant to arbitration under
Section 10.2, BSC, Cook or their Affiliates, as the case may be, shall be
entitled to rely upon an infringement Opinion from a law firm reasonably
acceptable to Angiotech, which opinion shall be controlling for purposes of this
Section 8.11.
9. TERMINATION
9.1 Early Termination of Licenses. Notwithstanding the foregoing, and subject to the limitations set forth below, Angiotech shall be entitled in the following circumstance to terminate one or more of the licenses granted to a party pursuant to Section 2.1 in the following circumstances:
(a) Material Breach. If either BSC or Cook materially breaches this Agreement, Angiotech shall have the right, at its election, to terminate any or all 1icenses granted by it to such breaching party under this Agreement upon forty-five (45) days, or thirty (30) days in the case of breach for non-payment, prior written notice, provided, however, that if the breaching party shall cure the breach or default within the forty-five (45) or thirty (30) day period, as applicable, all such licenses and agreements shall continue in full force and effect.
(b) Insolvency, Etc. If either BSC or Cook shall file a petition in bankruptcy or if an involuntary petition shall be filed against it and such petition shall not be dismissed within sixty (60) days, or if it shall become insolvent or admit its inability to pay its debts when due, or if a receiver or guardian shall be appointed for it, then all licenses granted to such party under this Agreement shall immediately terminate.
(c) Abandonment. If either Cook or BSC shall have acknowledged in writing its intention to abandon the commercial development of products based on the Angiotech Technology, Angiotech shall have the right, at its election, to terminate any and all licenses granted by it to such abandoning party under this Agreement upon thirty (30) days prior written notice.
(d) Failure to Exploit. In the event that either BSC or Cook shall have failed to (i) file an Investigational Device Exemption with the FDA or an equivalent filing with an appropriate governmental authority in one or more European countries with respect to a product incorporating or utilizing the Angiotech Technology prior to the thirty-month anniversary of the date of this Agreement, or (ii) file a Pre-market Approval Application or Section 510(K) Pre-Marketing Notification with the FDA or equivalent filing with an appropriate governmental authority in one or more European countries prior to the sixty-month anniversary of the date of this Agreement, then Angiotech shall have the right, at its election, to terminate any and all licenses granted by it to such party under this Agreement upon thirty (30) days prior written notice at any time prior to such filing.
(e) Limitation on Stent Products. If, for a period of five (5) years during the term of this Agreement, BSC or Cook is unable to obtain approval for, and gain significant sales of, an Eligible Stent Product in the United States, Angiotech shall have the right, at its election, to terminate any and all licenses in the United States granted by it to such party under this Agreement upon thirty (30) days prior written notice.
(f) Termination of NIH Agreement. In the event of a
termination of the NIH License, (i) the Cook License and the BSC License,
insofar as they relate to the NIH License only, shall terminate; provided,
however, that BSC and Cook shall have the right, in accordance with the terms of
Section 4.03 of the NIH Agreement, to convert the NIH License to a direct
license between NIH and BSC and Cook, and (ii) each of BSC and Cook shall be
permitted to terminate this Agreement as it relates to the licenses granted to
such parties hereunder and such party's obligations thereunder, upon thirty (30)
days prior written notice to Angiotech.
9.2 Termination-Supply of Paclitaxel. In the event that either BSC or Cook, as the case may be, is unable to acquire a supply of paclitaxel at commercially reasonable prices sufficient to enable BSC or Cook to practice the Angiotech Technology in accordance with the licenses granted under this Agreement, then the party which is unable to acquire such supply shall have the right, upon thirty (30) days prior written notice to Angiotech, to terminate the license granted to such party.
9.3 Effect of Termination. Promptly after termination of any
license, or part thereof, pursuant to Sections 9.1 or 9.2, Angiotech shall
deliver notice of such termination to the other licensee, if any, remaining
under Section 2.1 ( the "Remaining Licensee"). In the event of the termination
of some or all of the BSC License or the Cook License, as the case may be, the
obligations of the party to such license under Sections 3.1, 3.2 and 3.3, in the
case of BSC, or Sections 4.1, 4.2 and 4.3, in the case of Cook, and Sections 6.1
to 6.4, shall also terminate, other than with respect to royalty payments which
may have accrued in respect of sales of Eligible Products by such party during
the current Contract Quarter, and such termination shall have no effect on the
remaining license granted pursuant to Section 2.1. Within sixty (60) days of
delivery of such notice of termination to any Remaining Licensee, such party
shall have the option to cause the license granted to such party under such
Section 2.1 to become exclusive as to all other parties by delivering notice of
such election to Angiotech. In the event that such Remaining Licensee makes such
an election, such party shall assume the obligations of such terminated licensee
to make any unpaid milestone fees under Sections 3.1 or 4.1, as the case may be,
and the amount of such Remaining Licensee's original royalty obligations under
Section 3.2 or Section 4.2, as the case may be shall be increased by one percent
(1%) of Net Sales of Eligible Products. If the remaining licensee does not make
such an election within the period of sixty (60) days after delivery of notice
of any such termination pursuant to this Section 9.3, Angiotech shall be
permitted to grant a license to the Angiotech Technology to a single third
party.
9.4 Accrued Obligations. Upon termination of any license granted
under this Agreement for any reason, each of Angiotech and the holder of such
license shall remain liable for those obligations that accrued with respect to
such license prior to the effective date of the termination. The party to such
terminated license may, for a period of no longer than six (6) months after the
effective date of the termination of such license, complete and sell any or all
products containing Angiotech Technology that it can demonstrate were in the
process of manufacture or in inventory on the effective date of the
termination; provided, however, that such party shall remain obligated to pay
any applicable royalties thereon as provided in this Agreement. Within thirty
(30) days after receipt of notice of termination, each party to such license
shall provide the other with an accounting of products incorporating the
Angiotech Technology then on hand and in process and its best estimate of when
within the one (1) year period sales of such products will conclude.
10. DISPUTE RESOLUTION
10.1 Negotiation of Parties. In the event of any dispute with respect to the interpretation of any provision of this Agreement or with respect to the performance of either party under this Agreement, either party may at any time provide the other party written notice specifying the terms of such disagreement in reasonable detail. As soon as practicable after receipt of such notice, the President of Angiotech and a designated officer with appropriate settlement authority from BSC and/or Cook shall meet at a mutually agreed upon time and location for the purpose of resolving such disagreement. They shall engage in good faith discussions and/or negotiations for a period of up to thirty (30) days to resolve the disagreement
or negotiate an interpretation of revision of the applicable portion of this Agreement which is mutually agreeable to both parties, without the necessity of formal procedures relating thereto. During the course of such discussion and/or negotiation, the parties shall reasonably cooperate and provide information that is not materially confidential in order so that each of the parties may be fully informed with respect to the issues in dispute.
10.2 Arbitration. In the event any dispute arising between the parties concerning this Agreement is not resolved pursuant to Section 10.1, then the same shall be submitted by the parties to arbitration in Seattle, Washington in accordance with the then-current commercial arbitration rules of the American Arbitration Association ("AAA") except as otherwise provided herein. The parties shall choose, by mutual agreement, one (1) arbitrator within thirty (30) days of receipt of notice of the intent to arbitrate. If no arbitrator is appointed within the times herein provided or any extension of time which is mutually agreed upon, the AAA shall make such appointment within thirty (30) days of such failure. The judgment rendered by the arbitrator shall include costs of arbitration, reasonable attorneys' fees and reasonable costs for expert and other witnesses. Nothing in this Agreement shall be deemed as preventing either party from seeking injunctive relief (or any other provisional remedy) pursuant to Section 11.1 herein. If the issues in dispute involve scientific, technical or commercial matters, any arbitrator chosen hereunder shall have educational training and/or industry experience sufficient to demonstrate a reasonable level of relevant scientific, medical and industry knowledge.
10.3 NIH Agreement. Sections 10.1 or 10.2 shall not prevent Angiotech from seeking any remedies in law or equity it may have to protect its rights under the NIH Agreement.
11. GENERAL PROVISIONS
11.1 Remedies. The parties acknowledge and agree that, in the event of a breach or a threatened breach by either party of this Agreement for which it will have no adequate remedy at law, the other party may suffer irreparable damage and, accordingly, shall be entitled to injunctive and other equitable remedies to prevent or restrain such breach or threatened breach, without the necessity of posting any bond or surety, in addition to any other remedy they might have at law or at equity.
11.2 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Washington in force therein without regard to its conflict of law rules. Subject to Sections 10.1 and 10.2, all parties agree that by executing this Agreement they consent to the exclusive jurisdiction of the courts of the State of Washington.
11.3 Confidentiality. It is contemplated that in the course of the performance of this Agreement each party may, from time to time, disclose Confidential Information to the other. Each party agrees that for the term of this Agreement and for a period of five (5) years thereafter, the receiving party shall keep confidential and shall not publish or otherwise disclose, and will take all reasonable steps to prevent disclosure of, such Confidential Information and will not use any Confidential Information except for the limited purposes set forth in this Agreement; provided, however, that no provision of this Agreement shall be construed to
preclude such disclosure of Confidential Information as may be necessary or appropriate (i) to obtain from any governmental agency any necessary approval (subject to Section 11.9), (ii) to obtain patents that are included in the Angiotech Technology or (iii) to fulfill Angiotech's obligations under the CRADA and the NIH Agreement; provided, further, however, that the party whose information is to be disclosed shall be notified as soon as possible and the party that is being required to disclose such information shall, if requested by the party whose information is to be disclosed, use reasonable good faith efforts, at the expense of the requesting party, to assist in seeking a protective order (or equivalent) with respect to such disclosure or otherwise avoid making such disclosure.
11.4 Amendment and Waiver. No provision of or right under this Agreement shall be deemed to have been waived by any act or acquiescence on the part of any party, its agents or employees, but only by an instrument in writing signed by an authorized officer of such party. No waiver by either party of any breach of this Agreement by any other party shall be effective as to any other breach, whether of the same or any other term or condition and whether occurring before or after the date of such waiver.
11.5 Intellectual Property
(a) Trademarks. During the term of their respective licenses granted pursuant to Sections 2.1(a) and 2.1(b), each of BSC and Cook shall have the right to market and advertise products incorporating or utilizing Angiotech Technology under their respective names, trademarks, trade names, labels, or other designations, and the same shall remain the property of their respective owners, and Angiotech shall have no rights therein.
(b) Patents. BSC and Cook each agree to mark the Eligible Products or their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate "Patent Pending" status. All Eligible Products manufactured in, shipped to, or sold in other countries shall be marked in such a manner as to protect and preserve the Patent Rights in such countries.
11.6 Independent Contractors. Each party represents that it is acting on its own behalf as an independent contractor and is not acting as an agent for or on behalf of any third party. This Agreement and the relations hereby established by and among Angiotech, BSC and Cook do not constitute a partnership, joint venture, agency or contract of employment between them.
11.7 Assignment. Except with respect to any sublicenses granted by
BSC or Cook pursuant to Section 2.1, no party may assign its rights or
obligations hereunder without the prior written consent of the other parties,
which consent shall not be unreasonably withheld in the case of any assignment
pursuant to a merger, consolidation or sale of substantially all of the assets
or stock; provided, however, that either BSC or Cook may assign their respective
rights and obligations to an Affiliate of such party without consent if BSC or
Cook, as the case may be, agrees to remain liable for their obligations under
this Agreement and provided, that no purported assignment under this Section
11.7 shall be effective unless and until the proposed assignee under this
Section 11.7 agrees in writing to assume all of the obligations of the
assignor party under this Agreement and shall remain effective only so long as the proposed assignee remains an Affiliate.
11.8 Successors and Assigns. This Agreement shall bind and inure to the benefit of the parties hereto and their respective successors and permitted assigns.
11.9 Press Release. The parties agree that the public announcement of the execution of this Agreement shall be in the form of a press release to be agreed upon by the parties. Thereafter, Angiotech, BSC and Cook shall be free to use the information set forth in such press release in future public announcements. With respect to other public statements that reference a party, including submissions to the Securities and Exchange Commission or stock exchange or market system on which its securities are listed, such statements shall be submitted to the referenced party for review and approval, which approval shall not be untimely or unreasonably withheld.
11.10 Publications
(a) Subject to obligations under the NIH Agreement and agreements with third party collaborators, if any, BSC and Cook each agree that they shall not publish or present the results of studies carried out under this Agreement without the opportunity for prior review by Angiotech. Each of BSC and Cook shall provide to Angiotech the opportunity to review any proposed abstracts, manuscripts or presentations (including information to be presented orally) covering information arising from the use of the Angiotech Technology under this Agreement and not previously disclosed at least thirty (30) days prior to their intended submission for publication and such submitting party agrees, upon written request from Angiotech, not to submit such abstract or manuscript for publication or to make such presentation until Angiotech is given a reasonable period of time to secure patent protection for any material in such publication or presentation which it believes is patentable.
(b) Subject to obligations Under the NIH Agreement and agreements with third party collaborators, if any, Angiotech agrees that it shall not publish or present the results of studies relating to the Angiotech Technology licensed under this Agreement without the opportunity for prior review by BSC and Cook. Angiotech shall provide BSC and Cook the opportunity to review any proposed abstracts, manuscripts or presentations (including information to be presented orally) covering information related to the Angiotech Technology in the Licensed Field of Use under this Agreement and not previously disclosed at least thirty (30) days prior to its intended submission for publication.
11.11 Notices. All communications hereunder shall be in writing and shall be deemed to have been duly given upon receipt by the addressee at the addresses set forth below, or such other address as either party may specify by notice sent in accordance with this section:
If to BSC: Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760 Attention: Frank Grillo Director, New Business Development with a copy to: General Counsel Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 If to Angiotech: Angiotech Pharmaceuticals, Inc. 6660 N. W. Marine Drive Vancouver, BC, Canada V6T lZ4 Attention: President and Vice President-Corporate Affairs with a copy to: Venture Law Group 4750 Carillon Point Kirkland, WA 98033 Attention: William W. Ericson, Esq. If to Cook: Cook Incorporated 925 South Curry Pike Bloomington, Indiana 47403 Attention: Brian L. Bates with a copy to: Sommer and Barnard 4000 Bank One Tower 111 Monument Circle Indianapolis, Indiana 46204 Attention: Erick Ponader, Esq. |
11.12 Severabi1ity. In the event any provision of this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other term or provision hereof. The parties agree that they wil1 negotiate in good faith or will permit a court or arbitrator to replace any provision hereof so held invalid, illegal or unenforceable with a valid provision which is as similar as possible in substance to the invalid, illegal or unenforceable provision.
11.13 Conflict of Inconsistency. In the event of any conflict or inconsistency between the terms and conditions hereof and any terms or conditions set forth in any purchase order or other document relating to the transactions contemplated by this Agreement, the terms and conditions set forth in this Agreement shall prevail.
11.14 Captions. Captions of the Sections and subsections of this Agreement are for reference purposes only and do not constitute terms or conditions of this Agreement and shall not limit or affect the terms and conditions hereof.
11.15 Word Meanings. Words such as herein, hereinafter, hereof and hereunder refer to this Agreement as a whole and not merely to a Section or paragraph in which such words appear, unless the context otherwise requires. The singular shall include the plural, and each masculine, feminine and neuter reference shall include and refer also to the others, unless the context otherwise requires.
11.16 Entire Agreement. This Agreement and the Investment Agreement contain the entire understanding of each of the parties hereto with respect to the transactions and matters contemplated hereby, including without limitation any licensing of the Angiotech Technology, supersedes all prior agreements and understandings relating to the subject matter hereof, and no representations, inducements, promises or agreements, whether oral or otherwise, between such parties not contained herein or incorporated herein by reference shall be of any force or affect.
11.17 Rules of Construction. The parties agree that they have participated equally in the formation of this Agreement and that the language and terms of this Agreement shall not be presumptively construed against any of them.
11.18 Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. In making proof of this Agreement, it shall not be necessary to produce or account for more than one such counterpart.
[SIGNATURE PAGES FOLLOW]
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective duly authorized officers, and have duly delivered and executed this Agreement under seal as of the date first set forth above.
ANGIOTECH PHARMACEUTICALS, INC.
/s/ William L. Hunter ------------------------- By: WILLIAM L. HUNTER Title: CHAIRMAN & CEO |
BOSTON SCIENTIFIC CORPORATION
COOK INCORPORATED
SIGNATURE PAGE TO LICENSE AGREEMENT
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective duly authorized officers, and have duly delivered and executed this Agreement under seal as of the date first set forth above.
ANGIOTECH PHARMACEUTICALS, INC.
BOSTON SCIENTIFIC CORPORATION
/s/ Lawrence C. Best ------------------------- BY: Lawrence C. Best Title: Sr. Vice President and Chief Financial Officer |
COOK INCORPORATED
SIGNATURE PAGE TO LICENSE AGREEMENT
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective duly authorized officers, and have duly delivered and executed this Agreement under seal as of the date first set forth above.
ANGIOTECH PHARMACEUTICALS, INC.
BOSTON SCIENTIFIC CORPORATION
COOK INCORPORATED
/s/ Brian Bates ------------------------- By: BRIAN BATES Title: VICE PRESIDENT, PRODUCT DEVELOPMENT |
SIGNATURE PAGE TO LICENSE AGREEMENT
AGREEMENT WITH RESPECT TO
LICENSE AGREEMENT
AMONG
ANGIOTECH PHARMACEUTICALS, INC.
BOSTON SCIENTIFIC CORPORATION
AND
COOK INCORPORATED
This Agreement with respect to License Agreement is made and entered into as of this 13th day of December, 1999, by and between Angiotech Pharmaceuticals, Inc., a corporation organized under the laws of the Province of British Columbia ("Angiotech") and Boston Scientific Corporation, a Delaware corporation ("BSC").
WHEREAS, Angiotech, BSC and Cook Incorporated, an Indiana corporation ("Cook"), have entered into a License Agreement dated as of July 9, 1997, pursuant to which Angiotech agreed to license to each of BSC and Cook certain patents, patent applications, products and technology relating to the use of paclitaxel as a coating for certain medical devices (as may be amended from time to time, the "License Agreement");
WHEREAS, Angiotech and BSC desire to modify certain provisions of the License Agreement as they relate to Angiotech and BSC as provided herein;
NOW THEREFORE, Angiotech and BSC hereby agree as follows:
1. As between Angiotech and BSC, to replace Sections 3.1(a) and 3.1(b) in their entirety with the following:
3.1(a) BSC IDE Fee. Within twenty (20) business days after the date of the (x) first filing by BSC of an Investigational Device Exemption ("IDE") with the FDA or an equivalent filing in one or more European countries or Canada or (y) initiation of a BSC sponsored human clinical trial anywhere in the world, with respect to a product incorporating or utilizing the Angiotech Technology in a vascular application (the "BSC IDE Filing Date"), BSC shall pay a license fee in the amount of $1,275,000. 3.1(b) BSC PMA Fee. Within twenty (20) business days after the date of the (x) first filing by BSC of a Pre-Market Approval Application or Section 510(k) Pre-Market Notification (collectively, "PMA") with the FDA or an equivalent filing in on or more European. countries or Canada or (y) initiation of commercial sale by BSC anywhere in the world, with respect to a product incorporating or utilizing the Angiotech Technology in a vascular application (the "BSC PMA Filing"), BSC shall pay an additional license fee calculated as follows: |
(i) subject to Section 3.1(b)(iii) below, if the date of the BSC PMA Filing is on or after the twenty-four month anniversary of the date on which the applicable IDE or other equivalent filing in one or more European countries or Canada is approved or a BSC sponsored human clinical trial is initiated anywhere in the world (the "BSC IDE Approval Date"), the amount of $2,050,000; or (ii) if the date of the BSC PMA Filing is prior to the twenty-four month anniversary of the BSC IDE Approval Date, the amount of (x) $2,050,000 minus (y) the product of $200,000 for each complete thirty (30) days period by which the date of the BSC PMA Filing precedes the twenty-four month anniversary of the BSC IDE Approval Date, provided, however, that in no event shall any fee calculated pursuant to this Section 3.1(b)(ii) be less than $800,000; or (iii) if, and to the extent prior to the date of the BSC PMA Filing, the FDA or similar authority in Europe or Canada requires clinical follow-up in excess of nine (9) months and BSC is unable to make the BSC PMA Filing prior to the expiration of the "twenty-four (24) month" period referenced in Section 3.1(b)(ii) above, the amount of (x) $2,050,000, minus (y) the product of $1,00,000 for each compete thirty (30) day period by which the date of the BSC PMA Filing precedes the Extended BSC PMA Filing Date, provided, however, that in no event shall any fee calculated pursuant to this Section 3.1(b)(iii) be less than $800,000. For purposes of this paragraph," Extended BSC PMA Filing Date" means the date which is twenty-four (24) months following the BSC IDE Approval Date plus the number of months of required clinical follow-up in excess of nine (9) months. |
2. As between Angiotech and BSC, to add as Section 3.11 of the License Agreement, the following;
3.11 NeoRx License Fee Effective December 17, 1998, Angiotech entered into an exclusive license agreement (the "NeoRx License) with NeoRx Corporation ("NeoRx") which grants Angiotech an exclusive license, with right to sublicense, certain NeoRx Technology (as defined in the NeoRx License) relating to paclitaxel and its structural analogs for vascular applications. Angiotech and BSC agree that the BSC License shall be deemed to include a co-exclusive sublicense (with Cook) of the NeoRx Technology granted under the NeoRx License for the Field, are the terms and subject to the limitations and reservations set out in Section 2.1. As partial consideration of this sublicense, BSC agrees to pay to Angiotech an additional license fee in the maximum aggregate amount of Five Hundred Thousand Dollars ($500,000) as follows:
(i) Two Hundred Fifty Thousand Dollars ($250,000) payable on December 15, 1999; and
(ii) up to Two Hundred Fifty Thousand Dollars ($250,000) as negotiated in good faith by the parties on or prior to December 31, 2003.
Subject to the terms and conditions of the NeoRx License, Angiotech will provide BSC with a reasonable opportunity to review and provide input with respect to the preparation, filing, prosecution and maintenance of the NeoRx Patents and the NeoRx Interference. Angiotech, to the extent not prohibited by the NeoRx License, will forward copies to BSC of all materials available to it with respect to the NeoRx Patents. Under no circumstances may Angiotech surrender to NeoRx its rights to the NeoRx Patents, or any portion thereof, to the extent they relate to the Licensed Field of Use without the written consent of BSC.
3. As between Angiotech and BSC, to replace Section 9.1(d) in its entirety with the following
9.1(d) Failure to Exploit. In the event that BSC shall have failed to (i) file an Investigational Device Exemption ("IDE") with the FDA or an equivalent filing in one or more European countries or Canada or initiate a BSC sponsored human clinical trial anywhere in the world, with respect to a product incorporating or utilizing the Angiotech Technology prior to December 31, 2000 (the "BSC IDE Target Date"), or (ii) file a Pre-Market Approval Application or Section 51O(k) Pre-Marketing Notification (collectively, "PMA") with the FDA or equivalent filing in one or more European countries or Canada or initiate commercial sale anywhere in the world, with respect to a product incorporating or utilizing Angiotech Technology prior to December 31, 2003 (the "BSC PMA Target Date") then Angiotech shall have the right, at its election, to terminate any and all licenses granted by it to BSC under this Agreement upon thirty (30) days prior written notice at any time prior to such filing; provided however BSC may extend the BSC IDE Target Date and/or the BSC PMA Target Date by up to twelve (12) months by written notice to Angiotech, in which case the next amount due of the BSC IDE Fee and the BSC PMA Fee shall be increased by One Million Dollars ($1,000,000). In any event, if clause (i) above is not satisfied by December 31, 2000, BSC shall pay Angiotech within twenty (20) business days the amount of Five Hundred Thousand Dollars ($500,000). |
As between Angiotech and Cook, the original Section 9.1(d) shall remain in full force and effect until modified by Angiotech and Cook.
4. As between Angiotech and BSC, to replace Section 9.1(e) in its entirety with the following
9.1(e) Limitation on Stent Products. If, for a period of seven (7) years during the term of this Agreement BSC or Cook is unable to obtain approval for, and gain significant sales of, an Eligible Stent Product in the United States, Angiotech shall have the right, at its election, to terminate any and all licenses in the United States granted by it to such party under this Agreement upon thirty (30) days prior written notice. |
As between Angiotech and Cook, the original Section 9.1(e) shall remain in full force and effect until modified by Angiotech and Cook.
5. As between Angiotech and BSC, to add Section 9.1(f) as follows: 9.1(f) Unanticipated Regulatory Requirements. Both parties acknowledge the necessity to meet all applicable regulatory requirements in the major markets of the world (U.S., Europe and Japan). Both parties also acknowledge the uncertain regulatory requirements for a combination drug device product. If regulatory requirements create significantly longer timelines than currently anticipated (for instance, due to the requirements of a separate and distinct dose finding trial in a major market of the world), both parties shall meet to review the impact on timelines and to negotiate in good faith an extension to the BSC PMA Target Date and an extension to the seven year period described in Section 9.1(e) above. |
6. Angiotech and BSC agree that, except as provided in this Agreement, the License Agreement shall remain unmodified and shall continue in full force and effect.
IN WITNESS WHEREOF, the undersigned have duly executed this Agreement as of the date first set forth above.
ANGIOTECH PHARMACEUTICALS, INC.
By: /s/ Kenneth Mellquist ------------------------- Name: Kenneth Mellquist Title: Senior VP, Corporate Affairs |
BOSTON SCIENTIFIC CORPORATION
By: /s/ Lawrence C. Best ------------------------- Name: Title: |
EXHIBIT 10.12
BOSTON SCIENTIFIC CORPORATION
401(k) RETIREMENT SAVINGS PLAN
(Amended and Restated, Effective January 1, 2001)
TABLE OF CONTENTS
ARTICLE 1. INTRODUCTION................................................................................... 1 1.1. Qualification and Purpose....................................................................... 1 1.2. Rights under Plans.............................................................................. 1 1.3. Defined Terms................................................................................... 1 ARTICLE 2. PARTICIPATION.................................................................................. 2 2.1. Date of Participation........................................................................... 2 2.2. Duration of Participation....................................................................... 2 ARTICLE 3. CONTRIBUTIONS.................................................................................. 4 3.1. Elective Contributions.......................................................................... 4 3.2. Form and Manner of Elections.................................................................... 4 3.3. Matching Contributions.......................................................................... 4 3.4. Discretionary Contributions..................................................................... 5 3.5. Qualified Nonelective Contributions............................................................. 5 3.6. Rollover Contributions.......................................................................... 5 3.7. Employee Contributions.......................................................................... 5 3.8. Other Employer Contributions.................................................................... 5 3.9. Crediting of Contributions...................................................................... 6 3.10. Time for Making Contributions.................................................................. 6 3.11. Certain Limits Apply........................................................................... 6 3.12. Return of Contributions........................................................................ 6 3.13. Establishment of Trust......................................................................... 6 ARTICLE 4. PARTICIPANT ACCOUNTS........................................................................... 7 4.1. Accounts........................................................................................ 7 4.2. Adjustment of Accounts.......................................................................... 7 4.3. Investment of Accounts.......................................................................... 7 4.4. Appointment of Investment Manager or Named Fiduciary............................................ 8 4.5. Section 404(c) Compliance....................................................................... 8 4.6. Transfers From Other Plans...................................................................... 9 ARTICLE 5. VESTING OF ACCOUNTS............................................................................ 10 5.1. Immediate Vesting of Certain Accounts........................................................... 10 5.2. Deferred Vesting of Discretionary Contribution Accounts......................................... 10 5.3. Special Vesting Rules........................................................................... 10 5.4. Changes in Vesting Schedule..................................................................... 10 5.5. Forfeitures..................................................................................... 11 5.6. Vesting of Accounts Transferred From Other Plans................................................ 12 ARTICLE 6. WITHDRAWALS PRIOR TO SEVERANCE FROM EMPLOYMENT................................................. 13 6.1. Hardship Withdrawals............................................................................ 13 6.2. Withdrawals After Age 59 1/2.................................................................... 14 6.3. Withdrawal from Rollover Account................................................................ 14 6.4. Withdrawal on Account of Disability............................................................. 14 6.5. Withdrawal of Employee Contributions............................................................ 14 6.6. Restrictions on Certain Distributions........................................................... 14 6.7. Limitation of Withdrawable Amount............................................................... 15 6.8. Required Distributions After Required Beginning Date............................................ 15 |
6.9. Distributions Required by a Qualified Domestic Relations Order.................................. 15 6.10. Withdrawals by Certain Former Participants in Other Plans...................................... 15 ARTICLE 7. LOANS TO PARTICIPANTS.......................................................................... 16 7.1. In General...................................................................................... 16 7.2. Rules and Procedures............................................................................ 16 7.3. Maximum Amount of Loan.......................................................................... 16 7.4. Minimum Amount of Loans; Limit on Number of Loans............................................... 16 7.5. Note; Security; Interest........................................................................ 16 7.6. Repayment....................................................................................... 17 7.7. Repayment Upon Distribution..................................................................... 17 7.8. Default......................................................................................... 17 7.9. Note as Trust Asset............................................................................. 17 7.10. Nondiscrimination.............................................................................. 18 7.11. Designation of Accounts........................................................................ 18 7.12. Spousal Consent to Loans to Certain Former Participants in Other Plans......................... 18 ARTICLE 8. BENEFITS UPON DEATH OR SEVERANCE FROM EMPLOYMENT............................................... 19 8.1. Severance From Employment for Reasons Other Than Death.......................................... 19 8.2. Time of Distributions........................................................................... 19 8.3. Amount of Distribution.......................................................................... 20 8.4. Distributions After a Participant's Death....................................................... 20 8.5. Designation of Beneficiary...................................................................... 21 8.6. Direct Rollovers of Eligible Distributions...................................................... 21 8.7. Protected Forms of Benefit...................................................................... 23 8.8. Distribution Restrictions for Elective Contributions............................................ 23 ARTICLE 9. ADMINISTRATION................................................................................. 24 9.1. Committee....................................................................................... 24 9.2. Powers of Committee............................................................................. 24 9.3. Effect of Interpretation or Determination....................................................... 24 9.4. Reliance on Tables, etc......................................................................... 24 9.5. Claims and Review Procedures.................................................................... 25 9.6. Indemnification of Committee and Assistants..................................................... 25 9.7. Annual Report................................................................................... 25 ARTICLE 10. AMENDMENT AND TERMINATION..................................................................... 26 10.1. Amendment...................................................................................... 26 10.2. Termination.................................................................................... 26 10.3. Distributions upon Termination of the Plan..................................................... 26 10.4. Merger or Consolidation of Plan; Transfer of Plan Assets....................................... 26 ARTICLE 11. LIMITS ON CONTRIBUTIONS....................................................................... 27 11.1. Code Section 404 Limits........................................................................ 27 11.2. Code Section 415 Limits........................................................................ 27 11.3. Code Section 402(g) Limits..................................................................... 28 11.4. Code Section 401(k)(3) Limits.................................................................. 29 11.5. Code Section 401(m) Limits..................................................................... 33 ARTICLE 12. SPECIAL TOP-HEAVY PROVISIONS.................................................................. 37 12.1. Provisions to apply............................................................................ 37 12.2. Minimum Contribution........................................................................... 37 |
12.3. Adjustment to Limitation on Benefits........................................................... 38 12.4. Definitions.................................................................................... 38 ARTICLE 13. MISCELLANEOUS................................................................................. 41 13.1. Exclusive Benefit Rule......................................................................... 41 13.2. Limitation of Rights........................................................................... 41 13.3. Nonalienability of Benefits.................................................................... 41 13.4. Adequacy of Delivery........................................................................... 41 13.5. Reclassification of Employment Status.......................................................... 41 13.6. Veterans' Reemployment and Benefits Rights..................................................... 42 13.7. Governing law.................................................................................. 42 13.8. Authority to Correct Operational Defects....................................................... 42 13.9. Electronic Forms............................................................................... 42 ARTICLE 14. DEFINITIONS................................................................................... 43 14.1. "Accounts"..................................................................................... 43 14.2. "Affiliated Employer".......................................................................... 43 14.3. "Beneficiary".................................................................................. 43 14.4. "Board of Directors"........................................................................... 43 14.5. "Code"......................................................................................... 43 14.6. "Committee".................................................................................... 43 14.7. "Company Stock"................................................................................ 43 14.8. "Compensation"................................................................................. 43 14.9. "Disability"................................................................................... 44 14.10. "Discretionary Contribution".................................................................. 44 14.11. "Discretionary Contribution Account".......................................................... 44 14.12. "Elective Contribution"....................................................................... 45 14.13. "Elective Contribution Account"............................................................... 45 14.14. "Eligible Employee"........................................................................... 45 14.15. "Employee".................................................................................... 45 14.16. "Employee Contribution"....................................................................... 45 14.17. "Entry Date".................................................................................. 45 14.18. "ERISA"....................................................................................... 45 14.19. "Highly Compensated Employee"................................................................. 45 14.20. "Hour of Service"............................................................................. 46 14.21. "Leased Employee"............................................................................. 47 14.22. "Matching Contribution Account"............................................................... 47 14.23. "Normal Retirement Age"....................................................................... 47 14.24. "Participant"................................................................................. 47 14.25. "Participating Employer"...................................................................... 47 14.26. "Plan"........................................................................................ 47 14.27. "Plan Sponsor"................................................................................ 47 14.28. "Plan Year"................................................................................... 47 14.29. "Predecessor Employer"........................................................................ 47 14.30. "Qualified Domestic Relations Order".......................................................... 48 14.31. "Qualified Nonelective Contribution".......................................................... 48 14.32. "QNEC Account"................................................................................ 48 14.33. "Regulation".................................................................................. 48 |
14.34. "Required Beginning Date"..................................................................... 48 14.35. "Rollover Contribution"....................................................................... 48 14.36. "Section"..................................................................................... 48 14.37. "Trust"....................................................................................... 48 14.38. "Trustee"..................................................................................... 48 14.39. "Valuation Date".............................................................................. 48 14.40. "Year of Service for Vesting"................................................................. 48 |
ARTICLE 1. INTRODUCTION.
1.1. QUALIFICATION AND PURPOSE. This document amends and restates the provisions of the Boston Scientific Corporation 401(k) Retirement Savings Plan, effective as of January 1, 2001 unless otherwise stated herein. Mergers and account transfers of certain other plans into the Plan shall have such effective dates as are provided in Schedule B. The original effective date of the Plan was January 1, 1987. The Plan and its related Trust are intended to qualify as a profit-sharing plan and trust under Code sections 401(a) and section 501(a), the cash or deferred arrangement forming part of the Plan is intended to qualify under Code section 401(k). The Plan is intended to constitute a plan described in section 404(c) of ERISA. The provisions of the Plan and Trust shall be construed and applied accordingly. The purpose of the Plan is to provide benefits to Participants in a manner consistent and in compliance with such Code sections and Title I of ERISA. Notwithstanding the general effective date specified above, any provision of this restatement that is intended to comply with changes in law made by the Uniform Services Employment and Reemployment Rights Act of 1994, the Small Business Job Protection Act of 1996, the Taxpayer Relief Act of 1997, the Uruguay Round Agreements Act, or Internal Revenue Service regulations or other guidance thereunder, or Department of Labor guidance shall be effective as of the effective dates specified for such changes in the applicable statute, regulation, or guidance. In addition, this restatement contains certain provisions of the Economic Growth and Tax Relief Reconciliation Act of 2001 ("EGTRRA"). These provisions are intended as good faith compliance with the requirements of EGTRRA and are to be construed in accordance with EGTRRA and guidance issued thereunder. Except as otherwise provided, the EGTRRA provisions shall be effective as of the first day of the first Plan Year beginning after December 31, 2001. The EGTRRA provisions shall supersede the provisions of the Plan to the extent those provisions are inconsistent with the EGTRRA provisions.
1.2. RIGHTS UNDER PLANS. The rights of Participants in this Plan or any other plan which has been merged into this Plan, who ceased to be employed by the applicable employer prior to January 1, 2001 or, if later, the applicable merger date provided in Schedule B and have not thereafter been reemployed by the Plan Sponsor or an Affiliated Employer, and the rights of their beneficiaries, shall be determined in accordance with the terms of the applicable plan at the time they ceased to be employed.
1.3. DEFINED TERMS. All capitalized terms used in the following provisions of the Plan have the meanings given them under Article 14.
ARTICLE 2. PARTICIPATION.
2.1. DATE OF PARTICIPATION.
(a) Any individual who was a Participant on December 31, 2000 and is an Eligible Employee on January 1, 2001 will, subject to Section 2.2, continue to be a Participant.
(b) Any other individual will become a Participant on the Entry Date coinciding with or next following the latest of
(1) January 1, 2001;
(2) the date on which he or she becomes an Eligible Employee;
(3) the date on which he or she attains age 21; and
(4) the 30th day after the date he or she completes an Hour of Service;
provided that (i) he or she is an Eligible Employee on such Entry Date
and (ii) he or she has in effect on such Entry Date a compensation
reduction authorization described in Section 3.2 which was submitted in
the manner prescribed by the Committee. Unless otherwise provided by
the Committee, an Employee who has satisfied the requirements of (1),
(2), (3) and (4) above, but who has failed to satisfy the requirements
of (i) or (ii) above, will become a Participant on the first Entry Date
coinciding with or next following the date on which the requirements of
both (i) and (ii) are satisfied.
(c) Unless otherwise provided in Schedule B, in the event the
Plan Sponsor acquires a business of another employer, through an
acquisition of either assets or stock, an Employee who was employed by
such other employer immediately prior to such acquisition shall have
his or her prior service with such other employer taken into account,
as if it were service with an Affiliated Employer, for purposes of
(b)(4) above and Section 14.14(b).
(d) An Employee who, immediately before becoming an Eligible Employee, has a contribution agreement in effect with an Affiliated Employer under a separate plan described in section 401(k) of the Code shall become a Participant on the payroll date coinciding with or next following the date he or she becomes an Eligible Employee, provided that he or she has a compensation reduction authorization in effect on such payroll date.
2.2. DURATION OF PARTICIPATION. An individual who has become a Participant under the Plan will remain a Participant for as long as an Account is maintained under the Plan for his or her benefit, or until his or her death, if earlier. Notwithstanding the
preceding sentence and unless otherwise expressly provided for under the Plan, no contributions shall be made with respect to a Participant who is not an Eligible Employee. In the event a Participant remains an Employee but ceases to be an Eligible Employee and becomes ineligible for contributions, such Employee will again become eligible for contributions immediately upon returning to the class of Eligible Employees. In the event an Employee who is not an Eligible Employee becomes an Eligible Employee, such Employee will become a Participant on the first Entry Date on or after becoming an Eligible Employee, if he or she has satisfied the requirements of Section 2.1. A Participant or former Participant who is reemployed as an Eligible Employee shall again become eligible for contributions on the first Entry Date on or after reemployment.
ARTICLE 3. CONTRIBUTIONS.
3.1. ELECTIVE CONTRIBUTIONS. On behalf of each Participant for whom there is in effect, for any pay period, a compensation reduction authorization described in Section 3.2 and who is receiving Compensation from a Participating Employer during such pay period, such Participating Employer will contribute to the Trust, as an Elective Contribution, an amount equal to the amount by which such Compensation was reduced pursuant to the compensation reduction authorization. Elective Contributions for any pay period in a Plan Year may not be less than 1 percent nor exceed 15 percent of the Participant's Compensation for such pay period.
3.2. FORM AND MANNER OF ELECTIONS. A "compensation reduction authorization" is an authorization from an Eligible Employee to a Participating Employer which satisfies the requirements of this Section 3.2. Each compensation reduction authorization shall be in a form prescribed or approved by the Committee, and may be entered into as of any Entry Date upon such prior notice as the Committee may prescribe. A compensation reduction authorization may be changed by the Participant, with such prior notice as the Committee may prescribe, as of the first day of any payroll period. A compensation reduction authorization shall be effective with respect to Compensation payable on and after the applicable Entry Date. A compensation reduction authorization may be revoked by the Participant at any time, upon such prior notice as the Committee may prescribe. A Participant who revokes a compensation reduction authorization may enter into a new authorization only as of a subsequent Entry Date.
3.3. MATCHING CONTRIBUTIONS.
(a) On a bi-weekly basis, each Participating Employer will
make a Matching Contribution to the Trust for the benefit of each
Participant on whose behalf it made Elective Contributions for the
period. The amount of Matching Contributions made by a Participating
Employer for the period shall be equal to (i) 100% of the Elective
Contributions made on behalf of the Participant for the period which do
not exceed 2% of the Participant's Compensation for such period, plus
(ii) 50% of the Elective Contributions made on behalf of the
Participant for the period which exceed 2% but do not exceed 4% of the
Participant's Compensation for such period.
(b) If (i) a Participant is an Eligible Employee on the last day of the Plan Year, and (ii) the aggregate Matching Contributions made by his or her Participating Employer under paragraph (a) above to the Trust for the benefit of such Participant with respect to such Plan Year are less than the lesser of (1) 100% of the Participant's Elective Contributions for such Plan Year which do not exceed 2% of the Participant's Compensation for such Year plus 50% of the Participant's Elective Contributions for such Plan Year which exceed 2% but do not exceed 4% of the Participant's Compensation for such Year; or (2) 3% of such Participant's Compensation in such Plan Year, then the Participating Employer shall make a further contribution to the Trust, for the benefit of such Participant, to be credited
to his or her Matching Contribution Account, such that the aggregate Matching Contributions made by the Participating Employer for the benefit of such Participant for the Plan Year under this Section shall equal the lesser of the amounts set forth in clauses (1) and (2) above.
3.4. DISCRETIONARY CONTRIBUTIONS. For each Plan Year, the Participating Employers shall contribute to the Plan such other amounts, if any, as the Board of Directors, in its sole discretion, may determine. Any such Discretionary Contribution for a Plan Year shall be made in cash or, if the Board of Directors so directs, in Company Stock, and shall be allocated among and credited to the Accounts of each Participant who:
(a) is an Eligible Employee on the last day of the Plan Year; or
(b) has ceased to be an Eligible Employee during the Plan Year by reason of death or severance from employment after attaining age 62 or on account of Disability,
in proportion to their relative amounts of Compensation for such Plan Year.
3.5. QUALIFIED NONELECTIVE CONTRIBUTIONS. To the extent necessary to satisfy the Code Section 401(k)(3) limits with respect to Elective Contributions or the Code Section 401(m) limits with respect to Matching Contributions, the Plan Sponsor, in its discretion, may determine whether a Qualified Nonelective Contribution shall be made to the Trust for a Plan Year and, if so, the amount to be contributed by such Participating Employer. If the Plan Sponsor determines that a Qualified Nonelective Contribution shall be made, each Participating Employer shall contribute its designated portion. Qualified Nonelective Contributions shall be fully vested and subject to the same distribution rules as Elective Contributions as of the time such Qualified Nonelective Contributions are made to the Plan.
3.6. ROLLOVER CONTRIBUTIONS. An Eligible Employee (whether or not a Participant) may make a Rollover Contribution to the Plan upon demonstration to the Committee that the contribution is eligible for transfer to the Plan pursuant to the rollover provisions of the Code.
3.7. EMPLOYEE CONTRIBUTIONS. A Participant may elect to make after-tax Employee Contributions under the Plan in the form and manner prescribed or approved by the Committee. Employee Contributions for any pay period in a Plan Year may not be less than 1 percent nor exceed 10 percent of the Participant's Compensation for such period.
3.8. OTHER EMPLOYER CONTRIBUTIONS. The Participating Employers shall contribute to the Plan such other amounts as the Board of Directors determines on behalf of certain eligible Participants as set forth on Schedule C. Such contributions shall be made in cash and shall be allocated to an Employer Contribution Account of each eligible Participant as set forth on Schedule C.
3.9. CREDITING OF CONTRIBUTIONS. Each type of contribution for a Plan Year shall be allocated among and credited to the respective Accounts of Participants eligible to share in the contributions as of the Valuation Date next following the date the contributions are received by the Trustee.
3.10. TIME FOR MAKING CONTRIBUTIONS. Elective Contributions will be paid in cash to the Trust as soon as such contributions can reasonably be segregated from the general assets of the Participating Employer, but in any event no later than the time set forth in Department of Labor Regulations section 2510.3-102.
3.11. CERTAIN LIMITS APPLY. All contributions to the Plan are subject to the applicable limits set forth under Code sections 401(k), 402(g), 401(m), 404, and 415, as further described elsewhere in the Plan. In addition, certain minimum allocations may be required under Code section 416, as also further described elsewhere in the Plan.
3.12. RETURN OF CONTRIBUTIONS. If any contribution by a Participating Employer to the Trust is (a) made by reason of a mistake of fact, or (b) believed by the Participating Employer in good faith to be deductible under Code section 404, but the deduction is disallowed, the Trustee shall, upon request by the Participating Employer, return to the Participating Employer the excess of the amount contributed over the amount, if any, that would have been contributed had there not occurred a mistake of fact or a mistake in determining the deduction. Such excess shall be reduced by the losses of the Trust attributable thereto, if and to the extent such losses exceed the gains and income attributable thereto. In no event shall the return of a contribution hereunder cause any Participant's Accounts to be reduced to less than they would have been had the mistaken or nondeductible amount not been contributed. No return of a contribution hereunder shall be made more than one year after the mistaken payment of the contribution, or disallowance of the deduction, as the case may be.
3.13. ESTABLISHMENT OF TRUST. The Plan Sponsor will establish a Trust to accept and hold contributions made under the Plan. The Trust shall be governed by an agreement between the Plan Sponsor and the Trustee the terms of which shall be consistent with the Plan provisions and intended qualification under Code sections 401(a) and 501(a).
ARTICLE 4. PARTICIPANT ACCOUNTS.
4.1. ACCOUNTS. The Committee will establish and maintain (or cause the Trustee to establish and maintain) for each Participant, such Accounts as are necessary to carry out the purposes of this Plan.
4.2. ADJUSTMENT OF ACCOUNTS. As of each Valuation Date, each Account will be adjusted to reflect the fair market value of the assets allocated to the Account. In so doing,
(a) each Account balance will be increased by the amount of contributions, income and gain allocable to such Account since the prior Valuation Date; and
(b) each Account balance will be decreased by the amount of distributions from the Account and expenses and losses allocable to the Account since the prior Valuation Date.
Income, expense, gain or loss which is generated by a particular investment within the Trust shall be allocated among the Accounts invested in that investment in proportion to the balances of such Accounts as of the immediately preceding Valuation Date. Any expenses relating to a specific Account or Accounts, including without limitation commissions or sales charges with respect to an investment in which the Account participates, but excluding costs relating to the processing of Qualified Domestic Relations Orders, may be charged solely to the particular Account or Accounts.
4.3. INVESTMENT OF ACCOUNTS.
(a) A Participant's Accounts shall be invested by the Trustee as the Participant directs from among such investment options as the Plan Sponsor may make available from time to time in accordance with the investment policy established by the Committee. The Committee shall prescribe the manner in which such directions may be made or changed, the dates as of which they shall be effective, and the allocation of Accounts with respect to which no directions are submitted. Any other assets of the Trust not specified above in this Section shall be invested by the Trustee in the sole discretion of the Trustee and in accordance with its fiduciary duties under ERISA; provided, that if an investment manager or other named fiduciary has been appointed with respect to all or a portion of such assets, the Trustee shall invest such portion as the investment manager or other named fiduciary directs.
(b) The Committee is specifically authorized to establish a Company Stock investment option. To the extent such Company Stock has voting rights, or in the event of any tender or exchange offer by any person for such Company Stock, Participants invested in such Company Stock fund may direct the Trustee as to the voting and tender of such Company Stock in accordance with procedures established by the Committee. The Committee may also provide for the temporary suspension of the right of Participants subject to Section 16 of the Securities Exchange Act of 1934 to invest further amounts in the Company Stock fund following any withdrawal from the portion of such Participants' Accounts theretofore invested in such Company Stock fund. The Committee may also establish from time to time a maximum percentage of any Participant's Accounts which may be invested in the Company Stock fund.
(c) In connection with the acquisition of Schneider (USA) Inc. and Corvita Corporation, the Company established an investment fund to hold shares of Pfizer Inc. common stock transferred from the Pfizer Savings and Investment Plan. No contributions under this Plan may be invested in the Pfizer stock fund, and dividends and interest payable on the assets of the Pfizer stock fund allocated to the Accounts of a Participant will be invested according to such Participant's current investment election for contributions under the Plan. A Participant may direct that amounts held in the Pfizer stock fund on his or her behalf be transferred to one or more other investment funds made available by the Committee from time to time, and any amounts so transferred shall not be reallocated to the Pfizer stock fund.
4.4. APPOINTMENT OF INVESTMENT MANAGER OR NAMED FIDUCIARY. The Plan
Sponsor may appoint in writing one or more investment managers or other "named
fiduciaries" (within the meaning of ERISA section 402(a)(2)) to manage the
investment of all or designated portions of the assets held in the Trust. The
appointment shall be effective upon acknowledgment in writing by the investment
manager or other named fiduciary that it is a fiduciary with respect to the
Plan. An investment manager must be (a) registered as an investment adviser
under the Investment Advisers Act of 1940, (b) a bank as defined in that Act, or
(c) an insurance company qualified under the laws of more than one state to
manage, acquire or dispose of any assets of the Plan.
4.5. SECTION 404(c) COMPLIANCE. The Plan is intended to be an "ERISA
section 404(c) plan" as described in section 404(c) of ERISA and title 29 of the
Code of Federal Regulations section 2550.404c-1, and shall be administered and
interpreted in a manner consistent with that intent. The investment direction
requirements of Department of Labor regulation section 2550.404c-1(b)(2)(i)(B)
(1)(iv) and (b)(2)(i)(A) and the requirements relating to the investment
alternatives under the Plan are intended to be satisfied by Section 4.3 above,
in each case taking into account related communications to Participants and
beneficiaries under the summary plan description for the Plan and other
communications. For purposes of ERISA section 404(c), the "identified plan
fiduciary" obligated to comply with Participant and Beneficiary investment
instructions (except as provided in such section and regulations thereunder),
the identified plan fiduciary obligated to provide Participants and
Beneficiaries with the materials set forth in Department of Labor regulations
section 2550.404c-1(b)(2)(i)(B) and the identified plan fiduciary obligated to
comply with the confidentiality requirements and procedures under Department of
Labor regulations section 2550.404c-1(d)(2)(ii)(E)(4)(viii) relating to employer
securities shall be the Committee. The Committee may decline to implement
Participant and Beneficiary investment instructions which would result in a
prohibited transaction described in ERISA section 406 or section 4975 of the
Code or which would generate income that would be taxable to the Plan.
4.6. TRANSFERS FROM OTHER PLANS.
(a) Unless otherwise provided herein, in the event that another plan is merged into the Plan, or accounts are otherwise transferred to the Plan from another plan, the assets transferred to the Plan shall be allocated as follows:
(1) Assets attributable to an individual's elective contributions and qualified nonelective contributions (if any) shall be allocated to an Elective Contribution Account for his or her benefit under the Plan;
(2) Assets attributable to matching employer contributions (if any), shall be allocated to a Matching Contribution Account for his or her benefit under the Plan;
(3) Assets attributable to other employer contributions (if any), shall be allocated to a Discretionary Contribution Account for his or her benefit under the Plan; and
(4) Assets attributable to an individual's after-tax contributions (if any) shall be allocated to an after-tax contribution account for his or her benefit under the Plan.
The assets transferred may be separately accounted for in
sub-accounts under the Plan as determined to be necessary by the
Committee in order to administer the provisions of Articles 5, 6, 7 and
8. Unless otherwise provided in Schedule B or in an acquisition
agreement between a Participating Employer and the employer maintaining
such transferor plan, all assets transferred under this Section 4.6
shall be invested in accordance with investment directions by the
Participant under Section 4.3 above or, absent such directions, in a
fund designated by the Committee.
(b) Any individual for whom accounts have been transferred
under this Section 4.6 and who has not become a Participant under
Section 2.1, or pursuant to such other special eligibility rules
provided in Schedule B, shall be treated as a Participant for purposes
of Articles 4, 5, 8, 9, 10 and 13 and, so long as he or she is an
Employee, Articles 6 and 7. Such an individual shall become a
Participant for all purposes of the Plan to the extent such individual
satisfies the requirements of Section 2.1 or any other special
eligibility rules provided in Schedule B which apply to such
individual.
ARTICLE 5. VESTING OF ACCOUNTS.
5.1. IMMEDIATE VESTING OF CERTAIN ACCOUNTS. A Participant shall at all
times have a vested interest in 100% of the following accounts, as applicable:
Elective Contribution Account, Employee Contribution Account, QNEC Account,
Matching Contribution Account, his or her Rollover Account, and other accounts
that the Committee may establish, unless explicitly provided otherwise herein.
5.2. DEFERRED VESTING OF DISCRETIONARY CONTRIBUTION ACCOUNTS.
(a) A Participant who on December 31, 1992 had at least three Years of Service for purposes of calculating vesting, shall have a vested interest in 100% of his or her Discretionary Contribution Account, if any.
(b) A Participant not described in (a) above, shall have a vested interest in a percentage of his or her Discretionary Contribution Account, if any, determined in accordance with the following schedule and based on his or her Years of Service for Vesting:
Years of Service Applicable for Vesting Nonforfeitable Percentage ---------------- ------------------------- less than 1 0% 1 but less than 2 20% 2 but less than 3 40% 3 but less than 4 60% 4 but less than 5 80% 5 or more 100% |
5.3. SPECIAL VESTING RULES. Notwithstanding any provision of the Plan to the contrary, a Participant will have a vested interest in 100% of the Accounts maintained for his or her benefit upon the happening of any one of the following events:
(a) the Participant's attainment of age 62 while an Employee;
(b) the Participant's severance from employment on account of Disability;
(c) the Participant's death while an Employee;
(d) the termination of the Plan or the complete discontinuance of Contributions under the Plan; or
(e) the partial termination of the Plan with respect to the Participant.
5.4. CHANGES IN VESTING SCHEDULE. If the Plan's vesting schedule is amended, or the Plan is amended in any way that directly or indirectly affects the computation of a Participant's vested percentage (or if the Plan changes to or from a top-heavy vesting schedule), each Participant who
has completed 3 years of Vesting Service may elect, within the period described below, to have his or her vested percentage determined without regard to such amendment or change. The period referred to in the preceding sentence will begin on the date the amendment of the vesting schedule is adopted and will end 60 days after the latest of the following dates:
(a) the date on which such amendment is adopted;
(b) the date on which such amendment becomes effective; and
(c) the date on which the Participant is issued written notice of such amendment by the Committee.
5.5. FORFEITURES.
(a) In general. Any portion of a Participant's Account in which he or she is not vested upon severance from employment for any reason will be forfeited as of the earlier of
(1) the expiration of 5 consecutive Plan Years during each of which the Participant does not complete 501 Hours of Service, or
(2) the distribution of the vested portion of the Account if such distribution is made as a result of the Participant's severance from employment.
Any Participant who separates from the service of the Affiliated Employers prior to earning a vested interest in any of his or her Accounts shall be deemed to have received a complete distribution of his or her vested interest on the day he or she separates from service.
(b) Certain Restorations. Notwithstanding the preceding paragraph, if a Participant forfeits any portion of an Account as a result of the complete distribution of the vested portion of the Account but thereafter returns to the employ of an Affiliated Employer, the amount forfeited will be recredited to the Participant's Account if he or she repays to the Plan the entire amount distributed, without interest, prior to the earlier of (i) the close of the fifth consecutive Plan Year in each of which the Participant does not complete at least 501 Hours of Service or (ii) the fifth anniversary of the date on which the Participant is reemployed. In the case of a Participant who had earlier separated from service prior to earning a vested interest in any of his or her Accounts and was deemed to have received a distribution of such vested interest, the amount forfeited will be restored upon the Participant's reemployment prior to the close of the fifth consecutive Plan Year in each of which the Participant does not complete at least 501 Hours of Service. A Participant's vested percentage in the amount recredited under this paragraph will thereafter be determined under the terms of the Plan as if no forfeiture had occurred. The money required to effect the restoration of a Participant's Account shall come from other Accounts forfeited during the Plan Year of restoration, and to the extent such funds are inadequate, from a special contribution by the Participant's Participating Employer.
(c) If a Participant forfeits any part of his or her Accounts under paragraph (a) above, the amount of the forfeiture will be applied, first, toward any restoration of any
amount previously forfeited as required under paragraph (a) above, and, then, toward the Matching Contributions required to be made to the Plan under Section 3.3.
5.6. VESTING OF ACCOUNTS TRANSFERRED FROM OTHER PLANS. In the event that another plan is merged into the Plan, or accounts are otherwise transferred to the Plan from another plan, the portion of each Account under this Plan that is attributable to a vested and nonforfeitable account, or portion of an account, under the transferor plan shall remain vested and nonforfeitable under this Plan. The remaining portion of each Account under this Plan that is attributable to a transferor plan account shall vest in accordance with Section 5.2, unless otherwise provided in Schedule B.
ARTICLE 6. WITHDRAWALS PRIOR TO SEVERANCE FROM EMPLOYMENT.
6.1. HARDSHIP WITHDRAWALS.
(a) Immediate and heavy financial need. A Participant may make a withdrawal from his or her Elective Contribution Account in the event of an immediate and heavy financial need arising from
(i) expenses for medical care described in Code section 213(d) previously incurred by the Participant, his or her spouse or any of his or her dependents (as defined in Code section 152) or amounts necessary for these persons to obtain such medical care;
(ii) costs directly related to the purchase of a principal residence of the Participant (excluding mortgage payments);
(iii) the payment of tuition, room and board expenses and related educational fees for the next 12 months of post-secondary education for the Participant, his or her spouse, children or dependents (as defined in Code section 152);
(iv) payments necessary to prevent the eviction of the Participant from his or her principal residence or foreclosure on the mortgage on that principal residence; or
(v) any other need identified by the Commissioner of Revenue as a "financial hardship" for purposes of section 401(k) plans through the publication of revenue rulings, notices and other guidance of general applicability.
The Committee's determination of whether there is an immediate and heavy financial need as defined above shall be made solely on the basis of written evidence furnished by the Participant. Such evidence must also indicate the amount of such need.
(b) Distribution of amount necessary to meet need. As soon as practicable after the Committee's determination that an immediate and heavy financial need exists with respect to the Participant, that the Participant has obtained all other distributions (other than hardship distributions) and all nontaxable loans currently available under the Plan and all other plans maintained by the Affiliated Employers, and that no other resources are reasonably available to the Participant to satisfy the need, the Committee will direct the Trustee to pay to the Participant the amount necessary to meet the need created by the hardship (but not in excess of the value of the Participant's Elective Contribution Account, determined as of the Valuation Date that authorized distribution directions are received by the Trustee). The amount necessary to meet the need may include any amounts necessary to pay any federal, state, or local income taxes or penalties reasonably anticipated to result from the distribution. Distribution will be made solely from the Participant's Elective Contribution Account, and shall not include any portion of the Account that is attributable to income earned after December 31, 1988.
6.2. WITHDRAWALS AFTER AGE 59 1/2. A Participant who is an Employee and has attained age 59 1/2 may make a withdrawal from any one or more of his or her Accounts for any reason, upon such prior notice as the Committee may prescribe. Any such withdrawal shall be in the amount specified by the Participant, up to the vested value of the particular Account determined as of the Valuation Date that authorized distribution directions are received by the Trustee. Payment to the Participant shall be made as soon as practicable after such Valuation Date.
6.3. WITHDRAWAL FROM ROLLOVER ACCOUNT. A Participant who is an Employee may make a withdrawal from his or her Rollover Account for any reason, upon such prior notice as the Committee may prescribe. Any such withdrawal shall be in the amount specified by the Participant, up to the value of the Rollover Account determined as of the Valuation Date that authorized distribution directions are received by the Trustee. Payment to the Participant shall be made as soon as practicable after such Valuation Date.
6.4. WITHDRAWAL ON ACCOUNT OF DISABILITY. A Participant who is an Employee and who has a Disability, may make a withdrawal from his or her Accounts upon such prior notice as the Committee may prescribe. Any such withdrawal shall be in the amount specified by the Participant, up to the vested value of the Accounts determined as of the Valuation Date that authorized distribution directions are received by the Trustee. Payment to the Participant shall be made as soon as practicable after such Valuation Date.
6.5. WITHDRAWAL OF EMPLOYEE CONTRIBUTIONS. A Participant who is an Employee may make a withdrawal from his or her Employee Contribution Account for any reason upon such prior notice and in accordance with such procedures as the Committee may prescribe. Any such withdrawal shall be in the amount specified by the Participant in accordance with procedures prescribed by the Committee, up to the value of the Participant's Employee Contribution Account, determined as of the Valuation Date that authorized distribution directions are received by the Trustee. Payment to the Participant shall be made as soon as practicable after such Valuation Date.
6.6. RESTRICTIONS ON CERTAIN DISTRIBUTIONS. In the case of a Participant whose Accounts are valued in excess of $5,000 and who has not yet attained the Normal Retirement Age, no distribution may be made to the Participant under this Article unless
(a) between the 30th and 90th day prior to the date distribution is to be made, the Committee notifies the Participant in writing that he or she may defer distribution until the Normal Retirement Age and provides the Participant with a written description of the material features and (if applicable) the relative values of the forms of distribution available under the Plan; and
(b) the Participant consents to the distribution in writing after the information described above has been provided to him or her.
Notwithstanding the foregoing, such distribution may commence less than 30 days after the required notification described above is given, provided that (i) the Committee clearly informs the Participant that the Participant has a right to a period of at least 30 days after receiving the notice to consider whether or not to elect a distribution; and (ii) the Participant, after receiving the notice, elects a distribution.
For purposes of this Section, a Participant's Accounts will be considered to be valued in excess of $5,000 if the value of his or her Accounts exceeds such amount at the time of the distribution in question. For the avoidance of doubt, nothing in this Section confers a substantive distribution right to any Participant; a Participant must be eligible to receive a distribution pursuant to the other provisions of this Article 6 in order for this Section to apply.
6.7. LIMITATION OF WITHDRAWABLE AMOUNT. In the event that there is allocated to a Participant's Account a promissory note with respect to a loan made from the Plan, the maximum amount of cash that may be withdrawn from the Account prior to the Participant's severance from employment shall be determined without regard to the value of such note.
6.8. REQUIRED DISTRIBUTIONS AFTER REQUIRED BEGINNING DATE. In the case of a Participant who remains an Employee on or after his or her Required Beginning Date, such Participant's Accounts will be distributed, beginning on his or her Required Beginning Date, in accordance with the applicable requirements of Code section 401(a)(9) and the Regulations promulgated thereunder.
6.9. DISTRIBUTIONS REQUIRED BY A QUALIFIED DOMESTIC RELATIONS ORDER. To the extent required by a Qualified Domestic Relations Order, the Committee shall make distributions from a Participant's Accounts to alternate payees named in such order in a manner consistent with the distribution options otherwise available under the Plan, regardless of whether the Participant is otherwise entitled to a distribution at such time under the Plan.
6.10. WITHDRAWALS BY CERTAIN FORMER PARTICIPANTS IN OTHER PLANS.
(a) In addition to the rights to take withdrawals prior to severance from employment as described above, in the case of a Participant for whom amounts have been transferred under Section 4.6, the Participant shall be entitled to take withdrawals hereunder in the circumstances in which withdrawals prior to severance from employment would have been permitted under the transferor plan, as set forth in Schedule B.
(b) In the case of a married Participant for whom amounts have been transferred under Section 4.6 from another plan and who has at any time elected an annuity form of payment under Section 8.7, no withdrawal may be made under this article unless (i) his or her spouse consents in writing to such withdrawal, such consent acknowledges the effect of the withdrawal and is witnessed by a Plan representative or a notary public, and such consent specifies the form of the withdrawal (i.e., a lump sum cash payment), or (ii) it is established to the satisfaction of the Committee that the foregoing consent may not be obtained because the spouse cannot be located, or because of such other circumstances as the Secretary of the Treasury may prescribe.
ARTICLE 7. LOANS TO PARTICIPANTS.
7.1. IN GENERAL. Upon the written request of a Participant on a form
acceptable to the Committee, and subject to the conditions of this Article, the
Committee shall direct the Trustee to make a loan from the Trust to the
Participant. Notwithstanding the foregoing, a Participant who is an
owner-employee or member of the family (as defined in Code section 267(e)(4) of
an owner-employee is not eligible to receive a loan under this Article 7. An
"owner-employee" shall mean an owner employee as defined in Code section
401(c)(3), and shall include an employee or officer of an electing small
business (Subchapter S) corporation which is an Affiliated Employer who owns (or
is considered as owning within the meaning of Code section 318(a)(1)), on any
day during the taxable year of such corporation, more than 5% of the outstanding
stock of such corporation. For purposes of this Article, "Participant" includes
any Participant who is an Employee of a Participating Employer, and any other
Participant (or Beneficiary of a deceased Participant) who is a "party in
interest" within the meaning of ERISA section 3(14).
7.2. RULES AND PROCEDURES. The Committee shall promulgate such rules and procedures, not inconsistent with the express provisions of this Article, as it deems necessary to carry out the purposes of this Article including, but not limited to, rules for charging loan fees directly to a Participant's Accounts. All such rules and procedures shall be deemed a part of the Plan for purposes of the Department of Labor regulation section 2550.408b-1(d). Loans shall not be made available to Participants who are Highly Compensated Employees in an amount (determined under Department of Labor regulation section 2550.408b-1(b)) greater than the amount made available to other Participants.
7.3. MAXIMUM AMOUNT OF LOAN. The following limitations shall apply in determining the amount of any loan to a Participant hereunder:
(a) The amount of the loan, together with any other outstanding indebtedness of the Participant under the Plan or any other qualified retirement plans of the Affiliated Employers, shall not exceed $50,000 reduced by the excess of (i) the highest outstanding loan balance of the Participant from such plans during the one-year period ending on the day prior to the date on which the loan is made, over (ii) the Participant's outstanding loan balance from such plans immediately prior to the loan.
(b) The amount of the loan shall not exceed 50% of the Participant's vested interest in his or her Accounts, determined as of the Valuation Date immediately preceding the date of the loan.
7.4. MINIMUM AMOUNT OF LOANS; LIMIT ON NUMBER OF LOANS. The amount of any single loan under this Plan shall not be less than $1,000. No more than two loans may be outstanding to a Participant at any one time.
7.5. NOTE; SECURITY; INTEREST. Each loan shall be evidenced by a note signed by the Participant and shall be secured by the Participant's vested interest in his or her Accounts, including in such security the note evidencing the loan. The loan shall bear interest at a reasonable annual percentage interest rate to be determined by the Committee. In determining the interest rate, the
Committee shall take into consideration interest rates currently being charged by persons in the business of lending money with respect to loans made in similar circumstances.
7.6. REPAYMENT. Each loan made to a Participant who is receiving regular payments of compensation from a Participating Employer shall be repayable by payroll deduction. Loans made to other Participants (and, in all events, where payroll deduction is no longer practicable) shall be repayable in such manner as the Committee may from time to time determine. The documents evidencing a loan shall provide that payments shall be made not less frequently than quarterly and over a specified term as determined by the Committee (but not to exceed five years; ten years if the loan is being applied toward the purchase of a principal residence for the Participant); such documents shall also require that the loan be amortized with level payments of principal and interest. A Participant may prepay all, but not less than all, of his or her loan at any time, without penalty, by paying the loan principal then outstanding together with interest accrued and unpaid to the date of payment. Notwithstanding the foregoing, loan repayments may be suspended with respect to a Participant during any period he or she is performing qualified military service (as defined under Code section 414(u)) in accordance with Code section 414(u)(4).
7.7. REPAYMENT UPON DISTRIBUTION. If, at the time benefits are to be distributed (or to commence being distributed) to a Participant with respect to a severance from employment, there remains any unpaid balance of a loan hereunder, such unpaid balance shall, to the extent consistent with Department of Labor regulations, become immediately due and payable in full. Such unpaid balance, together with any accrued but unpaid interest on the loan, shall be deducted from the Participant's Accounts, subject to the default provisions below, before any distribution of benefits is made. Except as may be required in order to comply (in a manner consistent with continued qualification of the Plan under Code section 401(a)) with Department of Labor regulations, no loan shall be made or remain outstanding with respect to a Participant under this Article after the time distributions to the Participant with respect to a severance from employment are to be paid or commence.
7.8. DEFAULT. In the event of a default in making any payment of principal or interest when due under the note evidencing any loan under this Article, if such default continues for more than 90 days of the due date thereof, the unpaid principal balance of the note shall immediately become due and payable in full. Such unpaid principal, together with any accrued but unpaid interest, shall thereupon be deducted from the Participant's Accounts, subject to the further provisions of this Section. The amount so deducted shall be treated as distributed to the Participant and applied by the Participant as a payment of the unpaid interest and principal (in that order) under the note evidencing such loan. In no event shall the Committee apply the Participant's Accounts to satisfy the Participant's repayment obligation, whether or not he or she is in default, unless the amount so applied otherwise could be distributed in accordance with the Plan.
7.9. NOTE AS TRUST ASSET. The note evidencing a loan to a Participant under this Article shall be an asset of the Trust which is allocated to the Account of such Participant, and shall for purposes of the Plan be deemed to have a value at any given time equal to the unpaid principal balance of the note plus the amount of any accrued but unpaid interest.
7.10. NONDISCRIMINATION. Loans shall be made available under this Article to all Participants on a reasonably equivalent basis, except that the Committee may make reasonable distinctions based on creditworthiness.
7.11. DESIGNATION OF ACCOUNTS. Loans shall be made from the Participant's Accounts in such order as may be designated by the Committee, and loan repayments shall be credited to such Accounts in the same order. Loan repayments shall be allocated among the investment options in accordance with the Participant's then-effective instructions regarding the investment of contributions made on his or her behalf.
7.12. SPOUSAL CONSENT TO LOANS TO CERTAIN FORMER PARTICIPANTS IN OTHER PLANS. In the case of a married Participant for whom amounts have been transferred under Section 4.6 from a transferor plan and who has at any time elected an annuity form of payment under Section 8.7 or under the transferor plan, no loan shall be made unless (a) the Participant's spouse consents in writing to such loan and to the use of the Participant's Accounts as security for the loan, and such consent acknowledges the effect of the loan and the use of the Accounts as security, is witnessed by a Plan representative or a notary public, and is provided no more than 90 days before the date on which the loan is to be secured by the Accounts, or (b) it is established to the satisfaction of the Committee that the foregoing consent may not be obtained because there is no spouse, because the spouse cannot be located, or because of such other circumstances as the Secretary of the Treasury may prescribe.
ARTICLE 8. BENEFITS UPON DEATH OR SEVERANCE FROM EMPLOYMENT
8.1. SEVERANCE FROM EMPLOYMENT FOR REASONS OTHER THAN DEATH. Following a Participant's severance from employment of an Affiliated Employer for any reason other than death, the Participant will receive the vested portion of his or her Accounts in cash in a single sum or, if the Participant elects and the value of such portion exceeds $5,000, in monthly, quarterly, semi-annual, or annual installments, fixed installments or variable installments over a period certain not to exceed the Participant's life expectancy or the joint life and last survivor expectancy of the Participant and his or her Beneficiary. An election to receive monthly, quarterly, semi-annual, or annual installment distributions in lieu of a single sum, and the period over which such installments are to be made, shall be made by the Participant on a form approved by the Committee. Notwithstanding the foregoing, for Plan Years beginning on or after January 1, 2002, the installment options described above shall be available only with respect to a Participant whose annuity starting date is earlier than the earlier of (i) the 90th day after notice that such benefit forms will no longer be available is provided in accordance with Regulation section 1.411(d)-4, Q&A-2(e)(1) and (ii) the first day of the second Plan Year following the Plan Year in which the form of optional benefit is eliminated by amendment.
8.2. TIME OF DISTRIBUTIONS. Distribution with respect to a Participant's severance from employment normally will be made as soon as practicable after such severance. In the case of a Participant whose Accounts are valued in excess of $5,000 and who has not yet attained the Normal Retirement Age, however, distribution may not be made under this Section unless
(a) between the 30th and 90th day prior to the date distribution is to be made, the Committee notifies the Participant in writing that he or she may defer distribution until the Normal Retirement Age; and
(b) the Participant consents to the distribution in writing after the information described above has been provided to him or her, and files such consent with the Committee.
Notwithstanding the foregoing, such distribution may commence less than 30 days after the required notification described above is given, provided that (i) the Committee clearly informs the Participant that the Participant has a right to a period of at least 30 days after receiving the notice to consider whether or not to elect a distribution; and (ii) the Participant, after receiving the notice, elects a distribution.
A Participant's Accounts will be considered to be valued in excess of $5,000 if the value of such Accounts exceeds such amount at the time of the distribution in question. Distribution under this Section in all events will be made no later than the 60th day after the close of the Plan Year in which occurs the later of the Participant's severance from employment or the Participant's attainment of the Normal Retirement Age.
8.3. AMOUNT OF DISTRIBUTION.
(a) Single Sums. In the case of a distribution to be made in a single sum, the amount of the distribution shall be determined as of the Valuation Date on which authorized distribution directions are received by the Trustee.
(b) Installments. To the extent allowed in Section 8.1, in the case of distributions to be made in monthly, quarterly, semi-annual, or annual installments, the aggregate installment amount for a particular calendar year (the "installment year") shall be determined by dividing
(i) the value of the vested portion of the Participant's Accounts as of the last Valuation Date preceding the distribution date by
(ii) the lesser of (A) the number of remaining installment years in the installment period elected by the Participant as of the beginning of the installment year and (B) the number of years in the applicable remaining life expectancy for the installment year determined pursuant to regulations under Code section 401(a)(9).
8.4. DISTRIBUTIONS AFTER A PARTICIPANT'S DEATH.
(a) Death Prior to Severance From Employment. If a Participant dies prior to his or her severance from the service of the Participating Employers, the Participant's Beneficiary will receive the Participant's Accounts in either of the following forms, as elected by the Beneficiary on a form approved by the Committee:
(i) in cash in a single sum as soon as practicable following the Participant's death (but in no event later than December 31 of the calendar year following the year of the Participant's death); or
(ii) in monthly, quarterly, semi-annual, or annual installments over a period certain not to exceed the life expectancy of the Beneficiary, such installments to begin not later than December 31 of the calendar year following the year of the Participant's death and to be made in amounts determined in the same manner as under Section 8.3(b) above.
(b) Death After Severance From Employment. If a Participant dies after severance from employment but before the complete distribution of his or her Accounts has been made, the Participant's Beneficiary will receive the vested portion of the Participant's Accounts. Distribution will be made in cash in a single sum as soon as practicable following the Participant's death (but no later than December 31 of the calendar year following the year of the Participant's death) provided, however, that if distribution to the Participant had begun following his or her severance from employment in a form elected by the Participant, distribution will continue to be made to the Beneficiary at least as rapidly in such form unless the Beneficiary elects to receive the distribution in cash in a single sum as soon as practicable following the Participant's death. Any such election must be made on a
form approved by the Committee and must be received by the Committee within such period following the Participant's death as the Committee may prescribe.
Any distribution to a Beneficiary under this Section shall be determined as of the Valuation Date that authorized distribution directions are received by the Trustee.
8.5. DESIGNATION OF BENEFICIARY. Subject to the provisions of this Section, a Participant's Beneficiary shall be the person or persons and entity or entities, if any, designated by the Participant from time to time on a form approved by the Committee. In the absence of an effective beneficiary designation, the full amount payable upon the death of the Participant shall be paid to his or her surviving spouse or, if none, to his or her estate. If any Beneficiary survives the Participant but dies prior to receipt of his or her interest in the Participant's Account, such Beneficiary's remaining interest shall be paid to the Beneficiary's estate (unless the Participant had effectively designated a successor or contingent Beneficiary for the Beneficiary's remaining interest). A nonspouse beneficiary designation by a Participant who is married at the time of his or her death shall not be effective unless
(a) prior to the Participant's death, the Participant's
surviving spouse consented to and acknowledged the effect of the
Participant's designation of a specific non-spouse Beneficiary
(including any class of Beneficiaries or any contingent Beneficiaries)
on a written form approved by the Committee and witnessed by a notary
public or a duly authorized Plan representative; or
(b) it is established to the satisfaction of the Committee that spousal consent may not be obtained because there is no spouse, because the spouse has died (evidenced by a certificate of death), because the spouse cannot be located (based on information supplied by a government agency or independent investigator), or because of such other circumstances as the Secretary of the Treasury may prescribe; or
(c) the spouse had earlier executed a general consent form permitting the Participant (i) to select from among certain specified beneficiaries without any requirement of further consent by the spouse (and the Participant designates a Beneficiary from the specified list), or (ii) to change his or her Beneficiary without any requirement of further consent by the spouse. Any such general consent shall be on a form approved by the Committee, and must acknowledge that the spouse has the right to limit consent to a specific beneficiary and that the spouse voluntarily elects to relinquish such right.
In the event a spouse is legally incompetent to give consent, the spouse's legal guardian, even if the guardian is the Participant, may give consent on behalf of the spouse. Any consent and acknowledgment by (or on behalf of) a spouse, or the establishment that the consent and acknowledgment cannot be obtained, shall be effective only with respect to such spouse, but shall be irrevocable once made.
8.6. DIRECT ROLLOVERS OF ELIGIBLE DISTRIBUTIONS. Notwithstanding any provision of the Plan to the contrary that may otherwise limit a distributee's election under this Section, a distributee
may elect, at the time and in the manner prescribed by the Committee, to have any portion of an eligible rollover distribution paid directly to an eligible retirement plan specified by the distributee in a direct rollover. For purposes of this Section, the following terms have the following meanings:
(a) an "eligible rollover distribution" is any distribution of all or any portion of the balance to the credit of the distributee, except that an eligible rollover distribution does not include: any distribution that is one of a series of substantially equal periodic payments (not less frequently than annually) made for the life (or life expectancy) of the distributee or the joint lives of the distributee and the distributee's Beneficiary, or for a specified period of ten years or more; any distribution to the extent such distribution is required under Code section 401(a)(9); any distribution that is made on account of hardship; and the portion of any distribution that is not includible in gross income (determined without regard to the exclusion for net unrealized appreciation with respect to employer securities). Notwithstanding the foregoing, with respect to distributions made after December 31, 2001, a portion of a distribution shall not fail to be an eligible rollover distribution merely because the portion consists of after-tax Employee Contributions which are not includible in gross income. However, such portion may be transferred only to an individual retirement account or annuity described in section 408(a) or (b) of the Code, or to a qualified defined contribution plan described in section 401(a) or 403(a) of the Code that agrees to account separately for amounts so transferred, including separately accounting for the portion of such distribution which is includible in gross income and the portion of such distribution which is not so includible.
(b) with respect to a distributee, an "eligible retirement
plan" is an individual retirement account described in Code section
408(a), an individual retirement annuity described in Code section
408(b), an annuity plan described in Code section 403(a), or a
qualified trust described in Code section 401(a). With respect to
distributions made after December 31, 2001, an "eligible retirement
plan" shall also mean an annuity contract described in section 403(b)
of the Code and an eligible plan under section 457(b) of the Code which
is maintained by a state, political subdivision of a state, or any
agency or instrumentality of a state or political subdivision of a
state and which agrees to account separately for amounts transferred
into such plan from this Plan. Notwithstanding the foregoing, for
distributions prior to January 1, 2002, with respect to a distributee
who is a Participant's surviving spouse or a spouse or former spouse
who is the alternate payee under a qualified domestic relations order
as defined in section 414(p) of the Code, an eligible retirement plan
is only an individual retirement account or an individual retirement
annuity.
(c) a "distributee" includes an employee or former employee. In addition, the employee's or former employee's surviving spouse and the employee's or former employee's spouse or former spouse, who is an alternate payee under a Qualified Domestic Relations Order, are distributees with regard to the interest of the spouse or former spouse.
(d) a "direct rollover" is a payment by the Plan to the eligible retirement plan specified by the distributee.
8.7. PROTECTED FORMS OF BENEFIT. Notwithstanding any provision of this Plan to the contrary, in the event that the Plan Sponsor directs the Trustee to accept Plan assets for the benefit of Participants from another qualified retirement plan in connection with a merger or acquisition, or the adoption of the Plan by a Participating Employer, the Account balance attributable to such benefit shall be payable in the benefit form or forms so provided under the predecessor plan to the extent required by Code section 411(d)(6) and Regulations promulgated thereunder, or any successor Code provision (which forms of benefits shall be set forth on Schedule B to this Plan and identified with the appropriate Participating Employer); provided that, a form of benefit shall be retained pursuant to this Section only with respect to a Participant whose annuity starting date is earlier than the earlier of (i) the 90th day after notice that such form of optional benefit will no longer be available is provided in accordance with Regulation section 1.411(d)-4, Q&A-2(e)(1) and (ii) the first day of the second Plan Year following the Plan Year in which the term of optional benefit is eliminated by amendment.
8.8. DISTRIBUTION RESTRICTIONS FOR ELECTIVE CONTRIBUTIONS. Notwithstanding anything in the Plan to the contrary, a Participant's Elective Contribution Account shall be distributable only in accordance with Code section 401(k).
ARTICLE 9. ADMINISTRATION.
9.1. COMMITTEE. The Plan will be administered by a committee of individuals selected by the Board of Directors to serve at its pleasure. The Committee will be a "named fiduciary" for purposes of Section 402(a)(1) of ERISA with authority to control and manage the operation and administration of the Plan, and will be responsible for complying with all of the reporting and disclosure requirements of Part 1 of Subtitle B of Title I of ERISA. The Committee will not, however, have any authority over the investment of assets of the Trust in its capacity as Committee.
9.2. POWERS OF COMMITTEE. The Committee will have full discretionary power to administer the Plan in all of its details, subject, however, to the requirements of ERISA. For this purpose the Committee's discretionary power will include, but will not be limited to, the following authority:
(a) to make and enforce such rules and regulations as it deems necessary or proper for the efficient administration of the Plan or required to comply with applicable law;
(b) to interpret the Plan;
(c) to decide all questions concerning the Plan and the eligibility of any person to participate in the Plan;
(d) to compute the amounts to be distributed under the Plan, and to determine the person or persons to whom such amounts will be distributed;
(e) to authorize the payment of distributions;
(f) to keep such records and submit such filings, elections, applications, returns or other documents or forms as may be required under the Code and applicable regulations, or under other federal, state or local law and regulations;
(g) to allocate and delegate its ministerial duties and responsibilities and to appoint such agents, counsel, accountants and consultants as may be required or desired to assist in administering the Plan; and
(h) to allocate and delegate its fiduciary responsibilities in accordance with ERISA section 405.
9.3. EFFECT OF INTERPRETATION OR DETERMINATION. Any interpretation of the Plan or other determination with respect to the Plan by the Committee shall be final and conclusive on all persons in the absence of clear and convincing evidence that the Committee acted arbitrarily and capriciously.
9.4. RELIANCE ON TABLES, ETC. In administering the Plan, the Committee will be entitled, to the extent permitted by law, to rely conclusively on all tables, valuations, certificates, opinions and reports which are furnished by any accountant, trustee, counsel or other expert who is employed or engaged by the Committee or by the Plan Sponsor on the Committee's behalf.
9.5. CLAIMS AND REVIEW PROCEDURES. The Committee shall adopt procedures for the filing and review of claims in accordance with ERISA section 503.
9.6. INDEMNIFICATION OF COMMITTEE AND ASSISTANTS. Each Participating Employer agrees, jointly and severally, to indemnify and defend to the fullest extent of the law any Employee or former Employee (a) who serves or has served as a Committee member, (b) who has been appointed to assist the Committee in administering the Plan, or (c) to whom the Committee has delegated any of its duties or responsibilities against any liabilities, damages, costs and expenses (including attorneys' fees and amounts paid in settlement of any claims approved by the Plan Sponsor) occasioned by any act or omission to act in connection with the Plan, if such act or omission to act is in good faith and without gross negligence.
9.7. ANNUAL REPORT. The Committee shall submit annually to the Plan Sponsor a report showing in reasonable summary form, the financial position of the Trust and giving a brief account of the operations of the Plan for the past year, and such further information as the Plan Sponsor may reasonably require.
ARTICLE 10. AMENDMENT AND TERMINATION.
10.1. AMENDMENT. The Plan Sponsor reserves the power at any time or times to amend the provisions of the Plan and Trust to any extent and in any manner that it may deem advisable. Upon delivery to the Trustee and each Participating Employer of an amendment adopted by the Board of Directors, the Plan shall be amended at the time and in the manner set forth therein, and all Participants and all persons claiming an interest hereunder shall be bound thereby. Notwithstanding the foregoing, no action by the Board of Directors shall be required to amend the Plan to revise Schedule A, regarding the addition or removal of Participating Employers, or Schedule B, regarding a merger of, or transfer of accounts from, another plan into the Plan. Moreover, the Plan Sponsor may amend or modify any plan provisions which relate to ERISA section 404(c) compliance, including changes which would eliminate the Plan's status as an ERISA section 404(c) plan. However, the Plan Sponsor will not have the power:
(a) to amend the Plan or Trust in such manner as would cause or permit any part of the assets of the Trust to be diverted to purposes other than for the exclusive benefit of each Participant and his or her Beneficiary (except as permitted by the Plan with respect to Qualified Domestic Relations Orders or the return of contributions upon nondeductibility, mistake of fact, or the failure to qualify initially), unless such amendment is required or permitted by law, governmental regulation or ruling; or
(b) to amend the Plan or Trust retroactively in such a manner as would reduce the accrued benefit of any Participant, except as otherwise permitted or required by law. For purposes of this paragraph, an amendment which has the effect of decreasing a Participant's Account balance or eliminating an optional form of benefit, with respect to benefits attributable to service before the amendment, shall be treated as reducing an accrued benefit.
10.2. TERMINATION. The Plan Sponsor has established the Plan and authorized the establishment of the Trust with the bona fide intention and expectation that contributions will be continued indefinitely, but may discontinue contributions under the Plan or terminate the Plan at any time by written notice delivered to the Trustee without liability whatsoever for any such discontinuance or termination. In addition, the Participating Employers will have no obligation or liability whatsoever to maintain the Plan for any given length of time and may cease to be Participating Employers in a manner acceptable to the Plan Sponsor.
10.3. DISTRIBUTIONS UPON TERMINATION OF THE PLAN. Upon termination of the Plan by the Plan Sponsor, the Trustee will distribute to each Participant (or other person entitled to distribution) the value of the Participant's Accounts in a single sum as soon as practicable following such termination. The amount of such distribution shall be determined as of the Valuation Date that authorized distribution directions are received by the Trustee.
10.4. MERGER OR CONSOLIDATION OF PLAN; TRANSFER OF PLAN ASSETS. In case of any merger or consolidation of the Plan with, or transfer of assets and liabilities of the Plan to, any other plan, provision must be made so that each Participant would, if the Plan then terminated, receive a benefit immediately after the merger, consolidation or transfer which is equal to or greater than the benefit he or she would have been entitled to receive immediately before the merger, consolidation or transfer if the Plan had then terminated.
ARTICLE 11. LIMITS ON CONTRIBUTIONS.
11.1. CODE SECTION 404 LIMITS. The sum of the contributions made by each Participating Employer under the Plan for any Plan Year shall not exceed the maximum amount deductible under the applicable provisions of the Code. All contributions under the Plan made by a Participating Employer are expressly conditioned on their deductibility under Code section 404 for the taxable year when paid (or treated as paid under Code section 404(a)(6)).
11.2. CODE SECTION 415 LIMITS.
(a) Incorporation by reference. Code section 415 is hereby incorporated by reference into the Plan.
(b) Annual addition. The Committee shall determine an "annual addition" for each Participant for each limitation year, which shall consist of the following amounts:
(i) Elective Contributions allocated to the Participant's Accounts for the year;
(ii) Matching Contributions allocated to the Participant's Accounts for the year;
(iii) Qualified Nonelective Contributions allocated to the Participant's Accounts for the year;
(iv) Employee Contributions allocated to the Participant's Accounts for the year;
(v) forfeitures;
(vi) amounts allocated to an individual medical amount (as defined in Code section 415(l)(2)) which is part of a pension or annuity plan maintained by an Affiliated Employer; and
(vii) amounts derived from contributions paid or accrued which are attributable to post-retirement medical benefits allocated to the separate account of a key employee (as defined in Code section 419A(d)(3)) under a welfare benefit fund (as defined in Code section 419(e)) maintained by an Affiliated Employer.
(c) General limitation on annual additions. The annual addition of a Participant under (b) above for any limitation year, when added to the annual additions to his or her accounts for such year under all other defined contribution plans maintained by the Affiliated Employers, shall not exceed the lesser of (i) $30,000 (increased from time to time in accordance with Code section 415(d)), or (ii) 25% of the Participant's Compensation for such limitation year. For Plan Years beginning on or after January 1, 2002, the amount in (i) above shall be $40,000 (increased from time to time in accordance with Code section 415(d) and the amount in (ii) above shall be 100% of the Participant's Compensation for
such limitation year (or such other percentage as provided by Code section 415). The compensation limit referred to in (ii) above shall not apply to any contribution for medical benefits after separation from service (within the meaning of section 401(h) or section 419A(f)(2) of the Code), which is otherwise treated as an annual addition.
(d) Limitation Year. For purposes of determining the Code section 415 limits under the Plan, the "limitation year" shall be the Plan Year.
(e) Order of reductions. To the extent necessary to satisfy the limitations of Code section 415 for any Participant, the annual addition which would otherwise be made on behalf of the Participant under the Plan shall be reduced before the Participant's benefit is reduced under any and all defined benefit plans, and before the Participant's annual addition is reduced under any other defined contribution plan.
(f) Return of excess contributions. If, as a result of a reasonable error in estimating a Participant's Compensation for a Plan Year or limitation year, a reasonable error in determining the amount of elective deferrals (within the meaning of Code section 402(g)(3)) that may be made with respect to any individual under the limits of Code section 415, or under such other facts and circumstances as may be permitted under regulation or by the Internal Revenue Service, the annual addition under the Plan for a Participant would cause the Code section 415 limitations for a limitation year to be exceeded, the excess amounts shall be treated in accordance with the rules provided in Internal Revenue Service Reg. Section 1.415-6(b)(6).
11.3. CODE SECTION 402(G) LIMITS.
(a) In general. The maximum amount of Elective Contributions made on behalf of any Participant for any calendar year, when added to the amount of elective deferrals under all other plans, contracts and arrangements of an Affiliated Employer with respect to the Participant for the calendar year), shall in no event exceed the maximum applicable limit in effect for the calendar year under Regulation section 1.402(g)-1(d). For purposes of the Plan, an individual's elective deferrals for a taxable year are the sum of the following:
(i) Any elective contribution under a qualified cash or deferred arrangement (as defined in Code section 401(k)) to the extent not includible in the individual's gross income for the taxable year on account of Code section 402(a)(8) (before applying the limits of Code section 402(g) or this section);
(ii) Any employer contribution to a simplified employee pension (as defined in code section 408(k) to the extent not includible in the individual's gross income for the taxable year on account of Code section 402(h)(1)(B) (before applying the limits of Code section 402(g)); and
(iii) Any employer contribution to a custodial account or annuity contract under section 403(b) under a salary reduction agreement (within the meaning of Code section 3121(a)(5)(D)), to the extent not includible in the individual's gross
income for the taxable year on account of Code section 403(b) before applying the limits of Code section 402(g).
A Participant will be considered to have made "excess deferrals" for a taxable year to the extent that the Participant's elective deferrals for the taxable year exceed the applicable limit described above for the year.
(b) Distribution of excess deferrals. In the event that an amount is included in a Participant's gross income for a taxable year as a result of an excess deferral under Code section 402(g), and the Participant notifies the Committee on or before the March 1 following the taxable year that all or a specified part of an Elective Contribution made for his or her benefit represents an excess deferral, the Committee shall make every reasonable effort to cause such excess deferral, adjusted for allocable income, to be distributed to the Participant no later than the April 15 following the calendar year in which such excess deferral was made. The income allocable to excess deferrals is equal to the allocable gain or loss for the taxable year of the individual, but not the allocable gain or loss for the period between the end of the taxable year and the date of distribution (the "gap period"). Income allocable to excess deferrals for the taxable year shall be determined by multiplying the gain or loss attributable to the Participant's Elective Contribution Account for the taxable year by a fraction, the numerator of which is the Participant's excess deferrals for the taxable year, and the denominator of which is the sum of the Participant's Elective Contribution Account balance as of the beginning of the taxable year plus the Participant's Elective Contributions for the taxable year. No distribution of an excess deferral shall be made during the taxable year of a Participant in which the excess deferral was made unless the correcting distribution is made after the date on which the Plan received the excess deferral and both the Participant and the Plan designate the distribution as a distribution of an excess deferral. The amount of any excess deferrals that may be distributed to a Participant for a taxable year shall be reduced by the amount of Elective Contributions that were excess contributions and were previously distributed to the Participant for the Plan Year beginning with or within such taxable year.
(c) Treatment of excess deferrals. For other purposes of the Code, including Code sections 401(a)(4), 401(k)(3), 404, 409, 411, 412, and 416, excess deferrals must be treated as employer contributions even if they are distributed in accordance with paragraph (b) above. However, excess deferrals of a non-Highly Compensated Employee are not to be taken into account for purposes of Code section 401(k)(3) (the actual deferral percentage test) to the extent the excess deferrals are prohibited under Code section 401(a)(30). Excess deferrals are also to be treated as employer contributions for purposes of Code section 415 unless distributed under paragraph (b) above.
11.4. CODE SECTION 401(K)(3) LIMITS.
(a) In general. Elective Contributions made under the Plan are subject to the limits of Code section 401(k)(3), as more fully described below. The Plan provisions relating to the 401(k)(3) limits are to be interpreted and applied in accordance with Code sections 401(k)(3) and 401(a)(4), which are hereby incorporated by reference, and in such manner as
to satisfy such other requirements relating to Code section 401(k) as may be prescribed by the Secretary of the Treasury from time to time.
(b) Actual deferral ratios. For each Plan Year, the Committee will determine the "actual deferral ratio" for each Participant who is eligible for Elective Contributions. The actual deferral ratio shall be the ratio, calculated to the nearest one-hundredth of one percent, of the Elective Contributions (plus any Qualified Nonelective Contributions treated as Elective Contributions) made on behalf of the Participant for the Plan Year to the Participant's Compensation for the Plan Year. For purposes of determining a Participant's actual deferral ratio,
(i) Elective Contributions will be taken into account only if each of the following requirements are satisfied:
(A) the Elective Contribution is allocated to the Participant's Elective Contribution Account as of a date within the Plan Year is not contingent upon participation in the Plan or performance of services on any date subsequent to that date, and is actually paid to the Trust no later than the end of the 12-month period immediately following the Plan Year to which the contribution relates; and
(B) the Elective Contribution relates to Compensation that either would have been received by the Participant in the Plan Year but for the Participant's election to defer under the Plan, or is attributable to services performed in the Plan Year and, but for the Participant's election to defer, would have been received by the Participant within 2 1/2 months after the close of the Plan Year.
To the extent Elective Contributions which meet the requirements of (A) and (B) above constitute excess deferrals, they will be taken into account for each Highly Compensated Employee, but will not be taken into account for any non-Highly Compensated Employee;
(ii) in the case of a Participant who is a Highly Compensated Employee for the Plan Year and is eligible to have elective deferrals (and qualified nonelective contributions, to the extent treated as elective deferrals) allocated to his or her accounts under two or more cash or deferred arrangements described in Code section 401(k) maintained by an Affiliated Employer, the Participant's actual deferral ratio shall be determined as if such elective deferrals (as well as qualified nonelective or qualified) are made under a single arrangement, and if two or more of the cash or deferred arrangements have different Plan Years, all Plan Years ending with or within the same calendar year shall be treated as a single Plan Year;
(iii) the applicable period for determining Compensation for each Participant for a Plan Year shall be the 12-month period ending on the last day of such Plan Year; provided, that to the extent permitted under Regulations, the Committee may
choose, on a uniform basis, to treat as the applicable period only that portion of the Plan Year during which the individual was eligible to make Elective Contributions;
(iv) Qualified Nonelective Contributions made on behalf of Participants who are eligible to receive Elective Contributions shall be treated as Elective Contributions to the extent permitted by Regulation section 1.401(k)-1(b)(5);
(v) in the event that the Plan satisfies the requirements of Code sections 401(k), 410(a)(4), or 410(b) only if aggregated with one or more other plans with the same plan year, or if one or more other plans with the same Plan Year satisfy such Code sections only if aggregated with this Plan, then this section shall be applied by determining the actual deferral ratios as if all such plans were a single plan;
(vi) An employee who would be a Participant but for the failure to make Elective Contributions shall be treated as a Participant on whose behalf no Elective Contributions are made; and
(vii) Elective Contributions which are made on behalf of non-Highly Compensated Employees which could be used to satisfy the Code section 401(k)(3) limits but are not necessary to be taken into account in order to satisfy such limits, may instead be taken into account for purposes of the Code section 401(m) limits to the extent permitted by Regulation sections 1.401(m)-1(b)(5).
(c) Actual deferral percentages. Each Plan Year, the actual deferral ratios for all Highly Compensated Employees who are eligible for Elective Contributions for a Plan Year shall be averaged to determine the actual deferral percentage for the highly compensated group for the Plan Year, and the actual deferral ratios for all Employees who are not Highly Compensated Employees but are eligible for Elective Contributions for the Plan Year shall be averaged to determine the actual deferral percentage for the nonhighly compensated group for the Plan Year.
(d) Actual deferral percentage tests. For a Plan Year, at least one of the following tests must be satisfied:
(i) the highly compensated group's actual deferral percentage for the Plan Year does not exceed 125% of the prior year actual deferral percentage for the prior year nonhighly compensated group; or
(ii) the excess of the actual deferral percentage for the highly compensated group for the Plan Year over the prior year actual deferral percentage for the prior year nonhighly compensated group does not exceed two percentage points, and the actual deferral percentage for the highly compensated group for the Plan Year does not exceed twice the prior year actual deferral percentage for the prior year nonhighly compensated group.
For purposes of satisfying the above tests for a Plan Year, the "prior year actual deferral percentage for the prior year nonhighly compensated group" refers to the actual deferral
percentage determined for the immediately preceding Plan Year for the nonhighly compensated group existing during such preceding Plan Year. Notwithstanding the foregoing, in satisfying the above tests, the Committee may elect, in accordance with Code section 401(k)(3) and applicable regulations, to use the actual deferral percentage for the nonhighly compensated group determined for the current Plan Year.
(e) Adjustments by Committee. If, prior to the time all Elective Contributions for a Plan Year have been contributed to the Trust, the Committee determines that Elective Contributions are being made at a rate which will cause the Code section 401(k)(3) limits to be exceeded for the Plan Year, the Committee may, in its sole discretion, limit the amount of Elective Contributions to be made with respect to one or more Highly Compensated Employees for the balance of the Plan Year by suspending or reducing Elective Contribution elections to the extent the Committee deems appropriate. Any Elective Contributions which would otherwise be made to the Trust shall instead be paid to the affected Participant in cash.
(f) Excess contributions. If the Code section 401(k)(3) limits have not been met for a Plan Year after all contributions for the Plan Year have been made, the Committee will determine the amount of excess contributions with respect to Participants who are Highly Compensated Employees in the manner prescribed by Code section 401(k)(8) and by applicable regulations.
(g) Distribution of excess contributions. A Participant's excess contributions, adjusted for income, will be designated by the Participating Employer as a distribution of excess contributions and distributed to the Participant. The income allocable to excess contributions is equal to the allocable gain or loss for the Plan Year, but not the allocable gain or loss for the period between the end of the Plan Year and the date of distribution (the "gap period"). Income allocable to excess contributions for the Plan Year shall be determined by multiplying the gain or loss attributable to the Participant's Elective Contribution Account and QNEC Account balances by a fraction, the numerator of which is the excess contributions for the Participant for the Plan Year, and the denominator of which is the sum of the Participant's Elective Contribution Account and QNEC Account balances as of the beginning of the Plan Year plus the Participant's Elective Contributions and Qualified Nonelective Contributions for the Plan Year. Distribution of excess contributions will be made after the close of the Plan Year to which the contributions relate, but within 12 months after the close of such Plan Year. Excess contributions shall be treated as annual additions under the Plan, even if distributed under this paragraph.
(h) Special rules. For purposes of distributing excess contributions, the amount distributed with respect to a Highly Compensated Employee for a Plan Year shall be reduced by the amount of excess deferrals previously distributed to the Highly Compensated Employee for his or her taxable year ending with or within such Plan Year.
(i) Recordkeeping requirement. The Committee, on behalf of the Participating Employers, shall maintain such records as are necessary to demonstrate compliance with the
Code section 401(k)(3) limits, including the extent to which Qualified Nonelective Contributions are taken into account in determining the actual deferral ratios.
(j) Excise tax where failure to correct. If the excess contributions are not corrected within 2 1/2 months after the close of the Plan Year to which they relate, the Participating Employers will be liable for a 10 percent excise tax on the amount of excess contributions attributable to them, to the extent provided by Code section 4979. Qualified Nonelective Contributions properly taken into account under this Section for the Plan Year may enable the Plan to avoid having excess contributions, even if the contributions are made after the close of the 2 1/2 month period.
11.5. CODE SECTION 401(m) LIMITS.
(a) In General. Matching Contributions made under the Plan are
subject to the limits of Code section 401(m), as more fully described
below. The Plan provisions relating to the 401(m) limits are to be
interpreted and applied in accordance with Code sections 401(m) and
401(a)(4), which are hereby incorporated by reference, and in such
manner as to satisfy such other requirements relating to Code section
401(m) as may be prescribed by the Secretary of the Treasury from time
to time.
(b) Actual contribution ratios. For each Plan Year, the Administrator will determine the "actual contribution ratio" for each Participant who is eligible for Matching Contributions. The actual contribution ratio shall be the ratio, calculated to the nearest one-hundredth of one percent, of the sum of the Matching Contributions and Qualified Nonelective Contributions which are not treated as Elective Contributions made on behalf of the Participant for the Plan Year, to the Participant's Compensation for the Plan Year. For purposes of determining a Participant's actual contribution ratio,
(i) A Matching Contribution will be taken into account only if the Contribution is allocated to a Participant's Account as of a date within the Plan Year, is actually paid to the Trust no later than 12 months after the close of the Plan Year, and is made on behalf of a Participant on account of the Participant's Elective Contributions for the Plan Year;
(ii) in the case of a Participant who is a Highly Compensated Employee for the Plan Year and is eligible to have Matching Contributions or employee contributions (including amount treated as Matching Contributions) allocated to his or her accounts under two or more plans maintained by an Affiliated Employer which may be aggregated for purposes of Code sections 410(b) and 401(a)(4), the Participant's actual contribution ratio shall be determined as if such contributions are made under a single plan, and if two or more of the plans have different Plan Years, all Plan Years ending with or within the same calendar year shall be treated as a single Plan Year;
(iii) the applicable period for determining Compensation for each Participant for a Plan Year shall be the 12-month period ending on the last day of such Plan Year; provided that to the extent permitted under Regulations, the Administrator
may choose, on a uniform basis, to treat as the applicable period only that portion of the Plan Year during which the individual was eligible for Matching Contributions;
(iv) Elective Contributions not applied to satisfy the Code section 401(k)(3) limits and Qualified Nonelective Contributions not treated as Elective Contributions may be treated as Matching Contributions to the extent permitted by Regulation section 1.401(m)-1(b)(5);
(v) in the event that the Plan satisfies the requirements of Code sections 401(k), 410(a)(4), or 410(b) only if aggregated with one or more other plans with the same Plan Year, or if one or more other plans with the same Plan Year satisfy such Code sections only if aggregated with this Plan, then this section shall be applied by determining the actual deferral ratios as if all such plans were a single plan; and
(vi) any forfeitures under the Plan which are applied against Matching Contributions shall be treated as Matching Contributions.
(c) Actual contribution percentages. Each Plan Year, the actual contribution ratios for all Highly Compensated Employees who are eligible for Matching Contributions for a Plan Year shall be averaged to determine the actual contribution percentage for the highly compensated group for the Plan Year, and the actual contribution ratios for all Employees who are not Highly Compensated Employees but are eligible for Matching Contributions for the Plan Year shall be averaged to determine the actual contribution percentage for the nonhighly compensated group for the Plan Year.
(d) Actual contribution percentage tests. For a Plan Year, at least one of the following tests must be satisfied:
(i) the highly compensated group's actual contribution percentage for the Plan Year does not exceed 125% of the prior year actual contribution percentage for the prior year nonhighly compensated group; or
(ii) the excess of the actual contribution percentage for the highly compensated group for the Plan Year over the prior year actual contribution percentage for the prior year nonhighly compensated group does not exceed two percentage points, and the actual contribution percentage for the highly compensated group for the Plan Year does not exceed twice the prior year actual contribution percentage for the prior year nonhighly compensated group.
For purposes of satisfying the above tests for a Plan Year, the "prior year actual contribution percentage for the prior year nonhighly compensated group" refers to the actual contribution percentage determined for the immediately preceding Plan Year for the nonhighly compensated group existing during such preceding Plan Year. Notwithstanding the foregoing, in satisfying the above tests, the Committee may elect, in accordance with Code section 401(m)(2) and applicable regulations, to use the actual contribution percentage for the nonhighly compensated group calculated for the current Plan Year.
(e) Multiple use test. In the event that (i) the actual deferral percentage and actual contribution percentage for the highly compensated group exceed 125% of the respective actual deferral and actual contribution percentages for the nonhighly compensated group, and (ii) the sum of the actual deferral percentage and the actual contribution percentage for the highly compensated group exceeds the "aggregate limit" within the meaning of Regulation section 1.401(m)-2(b)(3), the Administrator shall reduce the actual contribution ratios of Highly Compensated Employees who had both an actual deferral ratio and an actual contribution ratio for the Plan Year to the extent required by such section and in the same manner as described in paragraph (f) below. The multiple use test described in Treasure Regulation section 401(m)-2 and this Section shall not apply for Plan Years beginning after December 31, 2001.
(f) Adjustments by Administrator. If, prior to the time all Matching Contributions for a Plan Year have been contributed to the Trust, the Administrator determines that such contributions are being made at a rate which will cause the Code section 401(m) limits to be exceeded for the Plan Year, the Administrator may, in its sole discretion, limit the amount of such contributions to be made with respect to one or more Highly Compensated Employees for the balance of the Plan Year by limiting the amount of such contributions to the extent the Administrator deems appropriate.
(g) Excess aggregate contributions. If the Code section 401(m) limits have not been satisfied for a Plan Year after all contributions for the Plan Year have been made, the excess of the aggregate amount of the Matching
Contributions (and any Qualified Nonelective Contribution or elective deferral taken into account in computing the actual contribution percentages) actually made on behalf of Highly Compensated Employees for the Plan Year over the maximum amount of such contributions permitted under Code section 401(m)(2)(A) shall be considered to be "excess aggregate contributions". The Committee will determine the amount of excess aggregate contributions with respect to Participants who are Highly Compensated Employees in the manner prescribed by Code section 401(m)(6)(C) and by applicable regulations
(h) Distribution of excess aggregate contributions. A Participant's excess aggregate contributions, adjusted for income, will be designated by the Participating Employer as a distribution of excess aggregate contributions, and distributed to the Participant. The income allocable to excess aggregate contributions is equal to the allocable gain or loss for the taxable year of the individual, but not the allocable gain or loss for the period between the end of the taxable year and the date of distribution (the "gap period"). Income allocable to excess aggregate contributions for the taxable year shall be determined by multiplying the gain or loss attributable to the Participant's Matching Contribution Account balances by a fraction, the numerator of which is the excess aggregate contributions for the Participant for the Plan Year, and the denominator of which is the sum of the Participant's Matching Contribution Account balances as of the beginning of the Plan Year plus the Participant's Matching Contributions for the Plan Year. Distribution of excess aggregate contributions will be made after the close of the Plan Year to which the contributions relate, but within 12 months after the close of such Plan Year. Excess aggregate contributions shall be treated as
employer contributions for purposes of Code sections 401(a)(4), 404, and 415 even if distributed from the Plan.
(i) Recordkeeping requirement. The Administrator, on behalf of the Participating Employers, shall maintain such records as are necessary to demonstrate compliance with the Code section 401(m) limits, including the extent to which Elective Contributions and Qualified Nonelective Contributions are taken into account in determining the actual contribution ratios.
(j) Excise tax where failure to correct. If the excess aggregate contributions are not corrected within 2 1/2 months after the close of the Plan Year to which they relate, the Participating Employers will be liable for a 10 percent excise tax on the amount of excess aggregate contributions attributable to them, to the extent provided by Code section 4979. Qualified Nonelective Contributions properly taken into account under this section for the Plan Year may enable the Plan to avoid having excess aggregate contributions, even if the contributions are made after the close of the 2 1/2 month period.
ARTICLE 12. SPECIAL TOP-HEAVY PROVISIONS.
12.1. PROVISIONS TO APPLY. The provisions of this Article shall apply for any top-heavy Plan Year notwithstanding anything to the contrary in the Plan.
12.2. MINIMUM CONTRIBUTION. For any Plan Year which is a top-heavy plan year, the Participating Employers shall contribute to the Trust a minimum contribution on behalf of each Participant who is not a key employee for such year and who has not separated from service from the Affiliated Employers by the end of the Plan Year, regardless of whether or not the Participant has elected to make Elective Contributions for the Year. The minimum contribution shall, in general, equal 3% of each such Participant's Compensation, but shall be subject to the following special rules:
(a) If the largest contribution on behalf of a key employee for such year, taking into account only Elective Contributions, Matching Contributions (if any), Discretionary Contributions and Qualified Nonelective Contributions, is equal to less than 3% of the key employee's Compensation, such lesser percentage shall be the minimum contribution percentage for Participants who are not key employees. This special rule shall not apply, however, if the Plan is required to be included in an aggregation group and enables a defined benefit plan to meet the requirements of Code section 401(a)(4) or 410.
(b) No minimum contribution will be required with respect to a Participant who is also covered by another top-heavy defined contribution plan of an Affiliated Employer which meets the vesting requirements of Code section 416(b) and under which the Participant receives the top-heavy minimum contribution.
(c) If a Participant is also covered by a top-heavy defined benefit plan of an Affiliated Employer, "5%" shall be substituted for "3%" above in determining the minimum contribution.
(d) The minimum contribution with respect to any Participant who is not a key employee for the particular year will be offset by any Discretionary Contributions and any Qualified Nonelective Contributions, but not any other type of contribution otherwise made for the Participant's benefit for such year. Notwithstanding the foregoing, for Plan Years beginning after December 31, 2001, the minimum contribution described above will be offset also by any Matching Contributions made for the Participant's benefit for such year.
(e) If additional minimum contributions are required under this Section, such contributions shall be credited to the Participant's Discretionary Contribution Account.
(f) A minimum contribution required under this Section shall be made even though, under other Plan provisions, the Participant would not otherwise be entitled to receive an allocation for the year because of (i) the Participant's failure to complete 1,000 hours of service (or any equivalent provided in the Plan), or (ii) the Participant's failure to make mandatory contributions or Elective Contributions to the Plan, or (iii) Compensation less than a stated amount.
12.3. ADJUSTMENT TO LIMITATION ON BENEFITS. With respect to Plan Years prior to January 1, 2001, for purposes of the Code section 415 limits, the definitions of "defined contribution plan fraction" and "defined benefit plan fraction" contained therein shall be modified, for any Plan Year which is a top-heavy Plan Year, by substituting "1.0" for "1.25" in Code sections 415(e)(2)(B) and 415(e)(3)(B).
12.4. DEFINITIONS. For purposes of these top-heavy provisions, the following terms have the following meanings:
(a) "key employee" means a key employee described in Code section 416, and "non-key employee" means any employee who is not a key employee (including employees who are former key employees);
(b) "top-heavy plan year" means a Plan Year if any of the following conditions exist:
(i) the top-heavy ratio for the Plan exceeds 60 percent and the Plan is not part of any required aggregation group or permissive aggregation group of plans;
(ii) this Plan is a part of a required aggregation group of plans but not part of a permissive aggregation group and the top-heavy ratio for the group of plans exceeds 60 percent; or
(iii) the Plan is part of a required aggregation group and part of a permissive aggregation group of plans and the top-heavy ratio for the permissive aggregation group exceeds 60 percent.
(c) "top-heavy ratio":
(i) If the employer maintains one or more defined contribution plans (including any Simplified Employee Pension Plan) and the employer has not maintained any defined benefit plan which during the 5-year period ending on the determination date(s) has or has had accrued benefits, the top-heavy ratio for the Plan alone or for the required or permissive aggregation group as appropriate is a fraction, the numerator of which is the sum of the account balances of all key employees on the determination date(s) (including any part of any account balance distributed in the 1-year period ending on the determination date(s)), and the denominator of which is the sum of all account balances (including any part of an account balance distributed in the 1-year period ending on the determination date(s) and in the case of a distribution made for a reason other than separation from service, death or disability, including any such amount distributed in the 5-year period ending in determination dates(s)), both computed in accordance with Code section 416. Both the numerator and the denominator of the top-heavy ratio are increased to reflect any contribution not actually made as of the determination date, but which is required to be taken into account on that date under Code section 416.
(ii) If the employer maintains one or more defined contribution plans (including any Simplified Employee Pension Plan) and the employer maintains or has maintained one or more defined benefit plans which during the 5-year period ending on the determination date(s) has or has had any accrued benefits, the top-heavy ratio for any required or permissive aggregation group as appropriate is a fraction, the numerator of which is the sum of the account balances under the aggregated defined contribution plan or plans for all key employees, determined in accordance with (i) above, and the present value of accrued benefits under the aggregated defined benefit plan or plans for all key employees as of the determination date(s), and the denominator of which is the sum of the account balances under the aggregated defined contribution plan or plans for all participants, determined in accordance with (i) above, and the present value of all accrued benefits under the defined benefit plan or plans for all participants as of the determination date(s), all determined in accordance with Code section 416. The accrued benefits under a defined benefit plan in both the numerator and denominator of the top-heavy ratio are increased for any distribution of an accrued benefit made in the 1-year period ending on the determination date.
(iii) For purposes of (i) and (ii) above, the value of account balances and the present value of accrued benefits will be determined as of the most recent valuation date that falls within or ends with the 12-month period ending on the determination date, except as provided in Code section 416 for the first and second plan years of a defined benefit plan. The account balances and accrued benefits of a participant (A) who is not a key employee but who was a key employee in a prior year, or (B) who has not been credited with at least one Hour of Service with any employer maintaining the plan at any time during the 1-year period ending on the determination date will be disregarded. The calculation of the top-heavy ratio, and the extent to which distributions, rollovers, and transfers are taken into account will be made in accordance with Code section 416. Deductible employee contributions will not be taken into account for purposes of computing the top-heavy ratio. When aggregating plans, the value of account balances and accrued benefits will be calculated with reference to the determination dates that fall within the same calendar year.
(iv) The accrued benefit of a Participant other than a key employee shall be determined under (A) the method, if any, that uniformly applies for accrual purposes under all defined benefit plans maintained by the employer, or (B) if there is no such method, as if such benefit accrued not more rapidly than the slowest accrual rate permitted under the fractional rule of Code section 411(b)(1)(C).
(d) The "permissive aggregation group" is the required aggregation group of plans plus any other plan or plan of the employer which, when considered as a group with the required aggregation group, would continue to satisfy the requirements of Code sections 401(a)(4) and 410.
(e) The "required aggregation group" is (i) each qualified plan of the employer in which at least one key employee participates or participated at any time during the determination period (regardless of whether the plan has terminated), and (ii) any other qualified plan of the employer which enables a plan described in (i) to meet the requirements of Code sections 401(a)(4) and 410(b).
(f) For purposes of computing the top-heavy ratio, the "valuation date" shall be the last day of the applicable plan year.
(g) For purposes of establishing present value to compute the top-heavy ratio, any benefit shall be discounted only for mortality and interest based on the interest and mortality rates specified in the defined benefit plan(s), if applicable.
(h) The term "determination date" means, with respect to the initial plan year of a plan, the last day of such plan year and, with respect to any other plan year of a plan, the last day of the preceding plan year of such plan. The term "applicable determination date" means, with respect to the Plan, the determination date for the Plan Year of reference and, with respect to any other plan, the determination date for any plan year of such plan which falls within the same calendar year as the applicable determination date of the Plan.
ARTICLE 13. MISCELLANEOUS.
13.1. EXCLUSIVE BENEFIT RULE. No part of the corpus or income of the Trust allocable to the Plan will be used for or diverted to purposes other than for the exclusive benefit of each Participant and Beneficiary, except as otherwise provided under the provisions of the Plan relating to Qualified Domestic Relations Orders, the payment of reasonable expenses of administering the Plan, the return of contributions upon nondeductibility or mistake of fact, or the failure of the Plan to qualify initially.
13.2. LIMITATION OF RIGHTS. Neither the establishment of the Plan or the Trust, nor any amendment thereof, nor the creation of any fund or account, nor the payment of any benefits, will be construed as giving to any Participant or other person any legal or equitable right against any Participating Employer or Committee or Trustee, except as provided herein, and in no event will the terms of employment or service of any Participant be modified or in any way be affected hereby. It is a condition of the Plan, and each Participant expressly agrees by his or her participation herein, that each Participant will look solely to the assets held in the Trust for the payment of any benefit to which he or she is entitled under the Plan.
13.3. NONALIENABILITY OF BENEFITS. The benefits provided hereunder will not be subject to the voluntary or involuntary alienation, assignment, garnishment, attachment, execution or levy of any kind, and any attempt to cause such benefits to be so subjected will not be recognized, except to such extent as may be required by law, except that if the Committee receives any Qualified Domestic Relations Order that requires the payment of benefits hereunder or the segregation of any Account, such benefits shall be paid, and such Account segregated, in accordance with the applicable requirements of such Order. In addition, the Account balance may be pledged as security for a loan from the Plan in accordance with the Plan's loan procedures.
13.4. ADEQUACY OF DELIVERY. Any payment to be made under the Plan by the Trustee may be made by the Trustee's check. Mailing to a person or persons entitled to distributions hereunder at the addresses designated by the Participating Employer or Committee shall be adequate delivery by the Trustee of such distributions for all purposes. In the event the whereabouts of a person entitled to benefits under the Plan cannot be determined after diligent search by the Committee, the Committee may place the benefits in a federally insured, interest-bearing bank account opened in the name of such person. Such action shall constitute a full distribution of such benefits under the terms of the Plan and Trust.
13.5. RECLASSIFICATION OF EMPLOYMENT STATUS. Notwithstanding anything herein to the contrary, an individual who is not characterized or treated as a common law employee of a Participating Employer shall not be eligible to participate in the Plan. However, in the event that such an individual is reclassified or deemed to be reclassified as a common law employee of a Participating Employer, the individual shall be eligible to participate in the Plan as of the actual date of such reclassification (to the extent such individual otherwise qualifies as an Eligible Employee hereunder). If the effective date of any such reclassification is prior to the actual date of such reclassification, in no event shall the reclassified individual be eligible to participate in the Plan retroactively to the effective date of such reclassification.
13.6. VETERANS' REEMPLOYMENT AND BENEFITS RIGHTS. Effective December 12, 1994 and notwithstanding any provision of the Plan to the contrary, contributions, benefits and service credit with respect to qualified military service will be provided in accordance with Code section 414(u).
13.7. GOVERNING LAW. The Plan and Trust will be construed, administered and enforced according to the laws of Massachusetts to the extent such laws are not preempted by ERISA.
13.8. AUTHORITY TO CORRECT OPERATIONAL DEFECTS. The Committee will have full discretionary power and authority to correct any "operational defect" of the Plan in any manner or by any method it deems appropriate in its sole discretion in order to cause the Plan (i) to operate in accordance with its terms or (ii) to maintain its tax-qualified status under the Code. For purposes of this Section, an "operational defect" is any operational or administrative action (or inaction) in connection with the Plan which, in the judgement of the Committee, fails to conform with the terms of the Plan or causes or could cause the Plan to lose its tax-qualified status under the Code.
13.9. ELECTRONIC FORMS. Notwithstanding any Plan provision to the contrary, to the extent the Committee allows any form or document under the Plan to be provided, completed or changed by means of telephone, computer or other paperless media, a paper document shall not be required for such form or document to be effective under the Plan.
ARTICLE 14. DEFINITIONS.
Wherever used in the Plan, the following terms have the following meanings:
14.1. "ACCOUNTS" mean, for any Participant, the accounts established under the Plan to which contributions made for the Participant's benefit, and any allocable income, expense, gain and loss, are allocated.
14.2. "AFFILIATED EMPLOYER" means (a) the Plan Sponsor, (b) any
corporation that is a member of a controlled group of corporations (as defined
in Code section 414(b)) of which the Plan Sponsor is also a member, (c) any
trade or business, whether or not incorporated, that is under common control (as
defined in Code section 414(c)) with the Plan Sponsor, (d) any trade or business
that is a member of an affiliated service group (as defined in Code section
414(m)) of which the Plan Sponsor is also a member, or (e) to the extent
required by Regulations issued under Code section 414(o), any other
organization; provided, that the term "Affiliated Employer" shall not include
any corporation or unincorporated trade or business prior to the date on which
such corporation, trade or business satisfies the affiliation or control tests
of, (b), (c), (d) or (e) above. In identifying any "Affiliated Employers" for
purposes of the Code section 415 limits, the definitions in Code sections 414(b)
and (c) shall be modified as provided in Code section 415(h).
14.3. "BENEFICIARY" means any person entitled to receive benefits under the Plan upon the death of a Participant.
14.4. "BOARD OF DIRECTORS" means the members of the Board of Directors of Boston Scientific Corporation.
14.5. "CODE" means the Internal Revenue Code of 1986, as amended from time to time. Reference to any section or subsection of the Code includes reference to any comparable or succeeding provisions of any legislation which amends, supplements or replaces such section or subsection, and also includes reference to any Regulation issued pursuant to or with respect to such section or subsection.
14.6. "COMMITTEE" means the entity or persons appointed by the Board of Directors to administer the Plan pursuant to its provisions.
14.7. "COMPANY STOCK" means any stock of the Plan Sponsor or an Affiliated Employer constituting a "qualifying employer security" within the meaning of section 407(d)(5) of ERISA.
14.8. "COMPENSATION" means,
(a) for purposes of determining the Code section 415 limits, the amount of any minimum contribution under the special top-heavy provisions, and determining the status of an individual as a "highly compensated employee" or a "key employee", the Participant's wages as defined in Code section 3401(a) for purposes of income tax withholding at the source, but (i) determined without regard to any rules that limit the remuneration included in wages based on the nature or location of the employment or the services performed, and
(ii) increased by any such amounts that would have been received by the individual from the Employer but for an election under Code section 125, 132(f)(4), 401(k), 402(h) or 403(b);
(b) for purposes of determining the Code section 415 limits and the amount of any minimum contribution under the special top-heavy provisions, the Participant's wages as defined in Code section 3401(a) for purposes of income tax withholding at the source but determined without regard to any rules that limit the remuneration included in wages based on the nature or location of the employment or the services performed;
(c) for purposes of the limits under Sections 11.4 and 11.5, "compensation" as defined under Code section 414(s) and the Treasury regulations thereunder; and
(d) for all other purposes under the Plan, the same as in (a) above, reduced by all of the following items (even if includable in gross income): cost-of-living adjustments, reimbursements or other expense allowances, pay in lieu of vacation upon termination of employment, bonuses, deferred compensation, payments under the Supplemental Severance Plan, and moving expenses, provided however that any elective contributions made by the Participating Employer that are not includible in gross income by reason of Code section 125 or 402(e)(3) shall in all cases be includible as "Compensation" for purposes of this paragraph (d). Notwithstanding the foregoing, for purposes of allocating Discretionary Contributions for a Plan Year, commissions paid to any field sales commissioned Employee who is a Highly Compensated Employee for such Plan Year shall be taken into consideration only to the extent of the lesser of (i) fifty percent of the amount of the commissions so paid, or (ii) the amount, not in excess of the commissions so paid, which when added to all other amounts paid such Employee and qualifying as Compensation results in an aggregate amount of Compensation of $85,000 or less.
(e) Compensation shall include only that compensation which is actually paid to the Participant during the applicable Plan Year. For all purposes under the Plan, Compensation for any individual will be limited for any Plan Year as provided under Code section 401(a)(17) (which for the 2001 Plan Year is $170,000 and for the 2002 Plan Year is $200,000). If the period for determining Compensation used in calculating a Participant's allocation for a determination period is shorter than 12 months, the annual Compensation limit shall be an amount equal to the otherwise applicable limit multiplied by a fraction, the numerator of which is the number of months in the period, and the denominator of which is 12.
14.9. "DISABILITY" means an injury or sickness which makes a Participant unable to perform each of the "essential functions" (as defined in the Boston Scientific Long Term Disability Plan) of any "gainful occupation" (as defined in the Boston Scientific Long Term Disability Plan) for which the Participant is reasonably fitted by training, education or experience.
14.10. "DISCRETIONARY CONTRIBUTION" means a contribution made for the benefit of a Participant by a Participating Employer in the discretion of the Board of Directors.
14.11. "DISCRETIONARY CONTRIBUTION ACCOUNT" means an Account to which Discretionary Contributions are allocated.
14.12. "ELECTIVE CONTRIBUTION" means a contribution made to the Plan for the benefit of a Participant pursuant to a compensation reduction authorization.
14.13. "ELECTIVE CONTRIBUTION ACCOUNT" means an Account to which Elective Contributions are allocated.
14.14. "ELIGIBLE EMPLOYEE" means, subject to Section 13.5, any Employee who
(a) is employed by a Participating Employer, and who, in the opinion of his or her Participating Employer, may reasonably be expected to complete 1,000 or more Hours of Service with a Participating Employer in a Plan Year; or
(b) any other Employee employed by a Participating Employer who has completed 1,000 or more Hours of Service in a computation period or has previously been an Eligible Employee described in (a) above.
The initial computation period shall be the 12-consecutive month period beginning on the date the Employee first performs an Hour of Service (the "employment commencement date"). The succeeding computation periods commence with the first Plan Year commencing after the Employee's employment commencement date. In no event will an individual become an Eligible Employee while he or she is characterized by an Affiliated Employer as (i) a Leased Employee, or (ii) a short-term employee.
14.15. "EMPLOYEE" means any individual employed by an Affiliated Employer, including any Leased Employee and any other individual required to be treated as an employee pursuant to Code sections 414(n) and 414(o).
14.16. "EMPLOYEE CONTRIBUTION" means the voluntary after-tax contribution made by a Participant under the Plan.
14.17. "ENTRY DATE" means the first day of each pay period during the Plan Year.
14.18. "ERISA" means the Employee Retirement Income Security Act of 1974, as from time to time amended, and any successor statute or statutes of similar import.
14.19. "HIGHLY COMPENSATED EMPLOYEE" means each individual employed by an Affiliated Employer who (i) during such Plan Year or preceding Plan Year, is a "5% owner" within the meaning of Code section 414(q), or (ii) during the preceding Plan Year received Compensation in excess of $85,000 (as adjusted under such Code section) and was in the "top paid group" as defined therein for such Plan Year.
14.20. "HOUR OF SERVICE" means, with respect to any Employee,
(a) Each hour for which the Employee is paid or entitled to payment for the performance of duties for an Affiliated Employer, each such hour to be credited to the Employee for the computation period in which the duties were performed;
(b) Each hour for which the Employee is directly or indirectly paid or entitled to payment by any Affiliated Employer (including payments made or due from a trust fund or insurer to which the Affiliated Employer contributes or pays premiums) on account of a period of time during which no duties are performed (irrespective of whether the employment relationship has terminated) due to vacation, holiday, illness, incapacity, disability, layoff, jury duty, military duty, or leave of absence, each such hour to be credited to the Employee for the computation period in which such period of time occurs, subject to the following rules;
(i) No more than 501 Hours of Service shall be credited under this paragraph (b) to the Employee on account of any single continuous period during which the Employee performs no duties;
(ii) Hours of Service shall not be credited under this paragraph (b) to an Employee for a payment which solely reimburses the Employee for medically related expenses incurred by the Employee, or which is made or due under a plan maintained solely for the purpose of complying with applicable workers' compensation, unemployment compensation or disability insurance laws; and
(iii) If the period during which the Employee performs no duties falls within two or more computation periods, and if the payment made on account of such period is not calculated on the basis of units of time, the number of Hours of Service credited with respect to such period shall be allocated between not more than the first two such periods based on the amount of the payment divided by the Employee's most recent hourly rate of Compensation before the period during which no duties were performed;
(c) Each hour not counted under paragraph (a) or (b) for which back pay, irrespective of mitigation of damages, has been either awarded or agreed to be paid by any Affiliated Employer, each such hour to be credited to the Employee for the computation period to which the award or agreement for back pay pertains, provided that crediting of Hours of Service under this paragraph (c) with respect to periods described in paragraph (b) above shall be subject to the limitations and special rules set forth in clauses (i), (ii) and (iii) of paragraph (b);
(d) Each noncompensated hour while an Employee during a period of absence from any Affiliated Employer in the armed forces of the United States if the Employee returns to work for any Affiliated Employer at a time when he or she has reemployment rights under federal law, and each noncompensated hour while an Employee on an unpaid leave of absence granted by the Employer; and
(e) Solely for purposes of Section 5.5, each hour not counted under paragraph (a) or (b) for which the Employee is absent from work for maternity or paternity reasons, provided that no more than 501 Hours of Service shall be credited under this paragraph (e) to the Employee. For purposes of this paragraph, an absence from work for maternity or paternity reasons means an absence (1) by reason of the pregnancy of the individual, (2) by reason of the birth of a child of the individual, (3) by reason of the placement of a child with the individual in connection with the adoption of such child by such individual, or (4) for purposes of caring for such child for a period beginning immediately following such birth or placement.
Hours of Service to be credited to an Employee under (a), (b) and (c) above will be calculated and credited pursuant to paragraphs (b) and (c) of Section 2530.200b-2 of the Department of Labor Regulations, which are incorporated herein by reference. Hours of Service to be credited to an Employee during a period described in (d) and (e) above will be determined by the Committee with reference to the individual's most recent normal work schedule, or at the rate of eight hours per day in the event the Committee is unable to establish such schedule.
14.21. "LEASED EMPLOYEE" means, for Plan Years beginning on or after January 1, 1997, any person (other than an employee of the Employer) who pursuant to an agreement between the recipient and any other person has performed services for the recipient (or for the recipient and related persons determined in accordance with Code section 414(n)(6)) on a substantially full-time basis for a period of at least one year, and such services are performed under the primary direction or control by the recipient.
14.22. "MATCHING CONTRIBUTION ACCOUNT" means an Account to which Matching Contributions are allocated.
14.23. "NORMAL RETIREMENT AGE" means age 62.
14.24. "PARTICIPANT" means each Eligible Employee who participates in the Plan pursuant to its provisions.
14.25. "PARTICIPATING EMPLOYER" means the Plan Sponsor and each other Affiliated Employer listed on Schedule A.
14.26. "PLAN" means the Boston Scientific Corporation 401(k) Retirement Savings Plan set forth herein, and all subsequent amendments thereto.
14.27. "PLAN SPONSOR" means Boston Scientific Corporation, a Delaware Corporation.
14.28. "PLAN YEAR" means the calendar year.
14.29. "PREDECESSOR EMPLOYER" means any trade or business acquired by a Participating Employer, or any entity from which a Participating Employer has acquired substantially all of its assets.
14.30. "QUALIFIED DOMESTIC RELATIONS ORDER" means any judgment, decree or order (including approval of a property settlement agreement) which constitutes a "qualified domestic relations order" within the meaning of Code section 414(p). A judgment, decree or order may still be considered to be a Qualified Domestic Relations Order if it requires a distribution to an alternate payee (or the segregation of accounts pending distribution to an alternate payee) before the Participant is otherwise entitled to a distribution under the Plan.
14.31. "QUALIFIED NONELECTIVE CONTRIBUTION" means a contribution made in the discretion of the Plan Sponsor which is designated by the Plan Sponsor as a Qualified Nonelective Contribution and which falls within the definition of a "qualified nonelective contribution" under Regulation section 1.401(k)-1(g)(13).
14.32. "QNEC ACCOUNT" means an Account to which Qualified Nonelective Contributions are allocated.
14.33. "REGULATION" means a regulation issued by the Department of Treasury, including any final regulation, proposed regulation, temporary regulation, as well as any modification of any such regulation contained in any notice, revenue procedure, or similar pronouncement issued by the Internal Revenue Service.
14.34. "REQUIRED BEGINNING DATE" for a Participant shall be determined as follows:
(a) For a Participant who is a five percent owner (as defined in Code section 416), the Required Beginning Date is April 1 following the calendar year in which the Participant attains age 70 1/2.
(b) For a Participant who is not a five percent owner, the Required Beginning Date is April 1 following the later of (A) the calendar year in which the Participant attains age 70 1/2 or (B) the calendar year in which the Participant incurs a severance from employment from the Participating Employers.
14.35. "ROLLOVER CONTRIBUTION" means a contribution made by a Participant which satisfies the requirements for rollover contributions as set forth in the Plan.
14.36. "SECTION" means a section of the Plan.
14.37. "TRUST" means the trust established under Section 3.13.
14.38. "TRUSTEE" means the person or persons who are at any time acting as trustee under the Trust.
14.39. "VALUATION DATE" means each day on which the New York Stock Exchange is open for trading.
14.40. "YEAR OF SERVICE FOR VESTING" means a Plan Year during which the Employee completes at least 1,000 Hours of Service. The following special rules shall apply:
(a) Unless otherwise provided in Schedule B, in the event the Plan Sponsor acquires a business of another employer, through an acquisition either of assets or stock of such other employer, an Employee who was employed by such other employer immediately prior to such acquisition shall have his or her prior service with such other employer taken into account, as if it were service with an Affiliated Employer.
(b) A Leased Employee shall accrue Years of Service for vesting purposes and shall be credited with such Years of Service for Vesting upon hire by a Participating Employer as a common law employee.
IN WITNESS WHEREOF, the Plan Sponsor has caused this instrument to be signed in its name and on its behalf by its duly authorized officer, this __day of ____________________, 2002.
BOSTON SCIENTIFIC CORPORATION
By: __________________________
Schedule A
(As of January 1, 2001, except as otherwise noted)
Participating Employer State of Incorporation ---------------------- ---------------------- Boston Scientific Corporation Delaware Boston Scientific Corporation Northwest Technology Center, Inc. Washington Boston Scientific Sales, Inc. Delaware Boston Scientific Technology, Inc. Minnesota BSC Finance Corporation Indiana BSC International Corporation Delaware BSC Technology, Inc. Minnesota Cardiac Pathways, Inc. (effective January 1, 2002) Delaware Cardiovascular Imaging Systems, Inc. California Catheter Innovations, Inc. (effective January 1, 2002) Delaware Celltechnix Corporation New Jersey Corvita Corporation Florida Embolic Protection, Inc. (effective January 1, 2002) Delaware EP Technologies, Inc. Delaware EP Technologies Sales, Inc. California Heart Technology Manufacturing, Inc. Washington |
Participating Employer State of Incorporation ---------------------- ---------------------- Interventional Technologies, Inc. (effective January 1, 2002) California Meadox Distribution Company New Jersey Meadox Instruments, Inc. New Jersey Meadox Medicals, Inc. New Jersey Meadox Medicals Sales, Inc. New Jersey Meadox Technology, Inc. Minnesota Quanam Medical Corporation (effective January 1, 2002) California Schneider (USA) Inc. Minnesota Scimed Life Systems, Inc. Minnesota Scimed, Inc. Minnesota Scimed Technology Inc. Minnesota Symbiosis Corporation Florida Target Therapeutics, Inc. Vesica Medical, Inc. California |
Schedule B
Special Provisions Regarding Former Participants in Other Plans
The following plans have been merged into this Plan as of the dates indicated below. Any elections made by participants in such plans with respect to contributions, beneficiaries, investments, loans or benefit distributions shall carry over and be treated as if made under this Plan, except as otherwise provided by the Committee.
1. Cardiovascular Imaging Systems, Inc. 401(k) Salary Reduction Plan and Trust
On October 3, 1995, the Cardiovascular Imaging Systems, Inc. 401(k) salary reduction plan was merged into this Plan.
Special participation rules (Section 2.1(c)): No Special rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting rules (Sections 5.6 and 14.40): No Special in-service withdrawal rules (Section 6.10(a)): No QJSA rules applicable (Section 8.7): Yes Optional forms of payment to preserve (Sections 8.1 and 8.7): |
Immediate life annuity.
Immediate life annuity with a period certain of 10, 15, or 20 years.
Immediate annuity for the life of the Participant, with a survivor annuity for the Participant's beneficiary which is 100%, 66 2/3% or 50% of the amount payable during the life of the Participant.
Any combination of the above options and the benefit forms described in Section 8.1.
2. Scimed Life Systems, Inc. Retirement Savings and Profit Sharing Plan
Effective January 1, 1996, the Scimed Life Systems, Inc. Retirement Savings and Profit Sharing Plan was merged into this Plan.
Special participation rules (Section 2.1(c)): No
Special rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting rules (Sections 5.6 and 14.40): No Special in-service withdrawal rules (Section 6.10(a)): No QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): No |
3. Symbiosis Corporation 401(k) Plan and Trust
Effective June 1, 1996, the Symbiosis Corporation 401(k) Plan and Trust was merged into this Plan.
Special Participation rules (Section 2.1(c)): No Special Rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting rules (Sections 5.6 and 14.40): No Special in-service withdrawal rules (Section 6.10(a)): No QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
4. American Home Products Corporation Savings Plan
Effective June 1, 1996, the accounts under the American Home Products Corporation Savings Plan attributable to Participants employed by Symbiosis Corporation were merged into this Plan.
Special Participation rules (Section 2.1(c)): No Special Rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting Rules (Sections 5.6 and 14.40): No Special in-service withdrawal rules (Section 6.10(a)): - 53 - |
Withdrawal from after-tax contribution account (Once per Plan Year; $500 minimum) QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
5. EPT 401(k) Plan
Effective as of the close of business on December 31, 1996, the EPT
401(k) Plan is hereby merged into this Plan.
Special participation rules (Section 2.1(c)): Yes
(i) Any individual who is a participant in the EPT 401(k) Plan (the "Former Plan") on December 31, 1996 shall become a Participant in the Plan as of January 1, 1997.
(ii) Each other Employee of EP Technologies, Inc. shall be subject to the participation rules under Section 2.1.
Special rules re allocation of transferred accounts (Section 4.6(a)): No
Special Vesting rules (Sections 5.6 and 14.40): Yes
(i) Any individual who is a participant in the EPT 401(k) Plan (the "Former Plan") on December 31, 1996 and who is actively employed by the Plan Sponsor or an Affiliated Employer on or after December 31, 1996 shall have a 100% nonforfeitable interest in the portion of his or her Accounts under this Plan that are attributable to the transfer of his or her employer matching contribution account balance, if any, from the Former Plan.
(ii) Any individual who is actively employed by EP Technologies, Inc. on December 31, 1996 and who has 3 or more years of service for purposes of calculating vesting (as determined under the Former Plan) shall have a vested interest in a percentage of his or her Discretionary Contribution Account under the Plan, if any, determined in accordance with the following schedule and based on his or her Years of Service for Vesting:
Years of Service Applicable for Vesting Nonforfeitable Percentage ---------------- ------------------------- 3 but less than 4 75% 4 or more 100% |
Special in-service withdrawal rules (Section 6.10(a)):
Hardship withdrawals allowed from any account which is 100% vested. QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
6. Heart Technology, Inc. 401(k) Profit Sharing Plan
Effective as of the close of business on December 31, 1996, the Heart Technology, Inc. 401(k) Profit Sharing Plan is hereby merged into this Plan.
Special Participation rules (Section 2.1(c)): Yes
(i) Any individual who is a participant in the Heart Technology, Inc. 401(k) Profit Sharing Plan (the "Former Plan") on December 31, 1996 shall become a Participant in the Plan as of January 1, 1997.
(ii) Any individual who is an active employee of Boston Scientific Corporation Northwest Technology Center, Inc. on December 31, 1996 and who has satisfied the eligibility requirements under the Former Plan as of December 31, 1996 (age 18 and the earlier of 6 months continuous employment or 1 year of service), but who has not yet enrolled in the Former Plan shall become a Participant in the Plan on the first Entry Date on or after January 1, 1997 on which such individual (a) is an Eligible Employee and (b) has in effect a compensation reduction authorization described in Section 3.2.
(iii) Any individual who is an active employee of Boston Scientific Corporation Northwest Technology Center, Inc. on December 31, 1996 and who has not yet satisfied the eligibility requirements under the Former Plan as of December 31, 1996 shall become a Participant in the Plan as of the Entry Date coinciding with or next following the date on which the individual (a) satisfies the eligibility requirements under Section 2.1, substituting age 18 for age 21 in Section 2.1(b)(3), (b) is an Eligible Employee and (c) has in effect a compensation reduction authorization described in Section 3.2.
(iv) Each other Employee of Boston Scientific Corporation Northwest Technology Center, Inc. shall be subject to the participation rules under Section 2.1.
Special Rules re allocation of transferred accounts (Section 4.6(a)): No
Special Vesting Rules (Sections 5.6 and 14.40): Yes
Any individual who is a participant in the Heart Technology, Inc. 401(k) Profit Sharing Plan (the "Former Plan") on December 31, 1996 and who is an active employee of the Plan Sponsor or an Affiliated Employer on or after December 31, 1996 shall have a 100% nonforfeitable interest in the portion of his or her Accounts under this Plan that are attributable to the transfer of his or her employer matching contribution account balance, if any, from the Former Plan.
Special in-service withdrawal rules (Section 6.10(a)): Yes
In-service withdrawals of rollover account; limited to once per year.
QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
7. Meadox Medicals, Inc. Employees' Savings Plan
Effective as of the close of business on December 31, 1996, the Meadox Medicals, Inc. Employees' Savings Plan is hereby merged into this Plan.
Special Participation rules (Section 2.1(c)): Yes
(i) Any individual who is a participant in the Meadox Medicals, Inc. Employees' Savings Plan (the "Former Plan") on December 31, 1996 shall become a Participant in the Plan as of January 1, 1997.
(ii) Any individual who is an active employee of Meadox Medicals, Inc. on December 31, 1996, but who has not yet enrolled in the Former Plan shall become a Participant in the Plan on any Entry Date on or after January 1, 1997, provided on such Entry Date such individual (a) is an Eligible Employee and (b) has in effect a compensation reduction authorization described in Section 3.2.
(iii) Each other Employee of Meadox Medicals, Inc. shall be subject to the participation rules under Section 2.1.
Special Rules re allocation of transferred accounts (Section 4.6(a)): No
Special Vesting Rules (Sections 5.6 and 14.40): Yes
Any individual who is a participant in the Meadox Medicals, Inc. Employees' Retirement Plan (the "Former Plan") on December 31, 1996 and is an active
employee of the Plan Sponsor or an Affiliated Employer on or after December 31, 1996 shall have a 100% nonforfeitable interest in the portion of his or her Accounts under this Plan that are attributable to the transfer of his or her employer matching contribution account balance, if any, from the Former Plan.
Special in-service withdrawal rules (Section 6.10(a)): Yes After-tax contribution account. No QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
8. Target Therapeutics, Inc. 401(k) Plan and Trust
Effective as of the close of December 31, 1997, the Target Therapeutics, Inc. 401(k) Plan and Trust was merged into this Plan.
Special Participation rules (Section 2.1(c)): No Special Rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting rules (Sections 5.6 and 14.40): No Special in-service withdrawal rules (Section 6.10(a)): No QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
9. Pfizer Savings and Investment Plan
Effective as of the close of November 30, 1998, the portion of the Pfizer Savings and Investment Plan and trust benefitting employees of Schneider (USA) Inc. and Corvita Corporation was merged into this Plan.
Special Participation rules (Section 2.1(c)): Yes
(i) Individuals who were employed by Schneider (USA) Inc. or Corvita Corporation on September 10, 1998 may participate in this Plan pursuant to Section 2.1(c) without regard to the age requirement of that Section.
(ii) Any Employee who was a participant in the Pfizer Savings and Investment Plan on September 9, 1998 shall become a Participant in this Plan as of September 10, 1998.
(iii) Each other individual who becomes an Employee of Schneider (USA) Inc. or Corvita Corporation shall be subject to the general participation rules of Section 2.1.
Special Rules re allocation of transferred accounts (Section 4.6(a)): Yes
In order to administer special distribution options with respect to contributions attributable to the NAMIC USA Corporation Profit Sharing and Incentive Savings Plan, Pfizer matching contributions and Pfizer after-tax employee contributions (and earnings on all such contributions) such contributions (and related earnings) shall be transferred into separate accounts or subaccounts under this Plan.
Special Vesting rules (Sections 5.6 and 14.40): No
Special in-service withdrawal rules (Section 6.10(a)): Yes
The Pfizer matching contribution account, after-tax employee contribution account, and former NAMIC accounts (attributable to contributions other than elective contributions) can be withdrawn in-service at any time.
Pfizer and NAMIC elective contribution accounts can be withdrawn on account of hardship or disability.
QJSA rules applicable (Section 8.7): Yes
(i) Former participants of the Pfizer Savings and Investment Plan must obtain spousal consent for loans and hardship withdrawals from their Pfizer accounts.
(ii) Accounts of Participants for whom NAMIC Accounts are maintained (i.e., former participants of the NAMIC USA Corporation Profit Sharing and Incentive Plan) are subject to the QJSA rules with respect to those accounts.
Optional forms of payment to preserve (Sections 8.1 and 8.7): Yes
(i) Lump sum withdrawals or distributions from the Pfizer stock fund can be distributed in shares of Pfizer common stock (with cash in lieu of any fractional shares) at the Participant's election.
(ii) NAMIC Accounts, in addition to the benefit forms described under Section 8.1 and 8.7, can be distributed as follows:
[ ] Immediate annuity for the life of the Participant, with a survivor annuity for the Participant's beneficiary which is 50% of the amount payable during the life of the Participant.
[ ] Immediate life annuity.
[ ] Other annuity options.
10. Catheter Innovations, Inc. 401(k) Retirement Savings Plan
Effective as of the close of December 31, 2001, the Catheter Innovations, Inc. 401(k) Retirement Savings Plan (the "Catheter Innovations Plan") and Trust shall be merged into this Plan.
Special Participation rules (Section 2.1(c)): No Special Rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting rules (Sections 5.6 and 14.40): No Special in-service withdrawal rules (Section 6.10(a)): No QJSA rules applicable (Section 8.7): Yes Optional forms of payment to preserve (Sections 8.1 and 8.7): 50% joint and survivor annuity. Straight life annuity. |
Single life annuity with period of certain of five, ten or fifteen years.
Single life annuity with installment refund
50%, 66(BETA)%, or 100% joint and survivor annuity with installment refund.
Fixed period annuity for any period of whole months which is not less than sixty and does not exceed the life expectancy of the Participant and the named Beneficiary.
Installments.
11. Quanam Medical Corporation 401(k) Plan
Effective as of the close of December 31, 2001, the Quanam Medical Corporation 401(k) Plan (the "Quanam Plan") and Trust shall be merged into this Plan.
Special Participation rules (Section 2.1(c)): No
Special Rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting rules (Sections 5.6 and 14.40): No Special in-service withdrawal rules (Section 6.10(a)): No QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
12. Interventional Technologies, Inc. 401(k) Plan
Effective as of the close of December 31, 2001, the Interventional Technologies, Inc. 401(k) Plan (the "IVT Plan") and Trust shall be merged into this Plan.
Special Participation rules (Section 2.1(c)): No Special Rules re allocation of transferred accounts (Section 4.6(a)): No Special Vesting rules (Sections 5.6 and 14.40 No Special in-service withdrawal rules (Section 6.10(a)): No QJSA rules applicable (Section 8.7): No Optional forms of payment to preserve (Sections 8.1 and 8.7): None |
Schedule C
Special 1998 Contribution
Pursuant to Section 3.8, during the 1998 Plan Year, the Participating Employers made a special contribution on behalf of certain Participants (as listed below) in the amounts as indicated:
Participants Receiving Amount of Special Special 1998 Contribution 1998 Contribution ------------------------- ----------------- Anderson Connie $1,196.07 Colon Eleanor $ 702.99 Davis Andrew $3,621.51 Khammanivong Lounh $ 133.28 Lynch Elizabeth $ 955.41 Montuori John $ 59.59 Munoz Mauro $ 498.25 Murley Joyce $ 113.59 Ouk Dara $ 139.34 Panescu Dorin $ 210.66 Reineck Jean $ 17.25 Shah Krunal $ 287.47 Vierra Jean $1,277.98 Zweirs Douglas $3,323.15 Schallehn Marcia $ 494.02 Lambert Jose $ 974.21 Miranda Gilbert $1,817.55 Vnuk Theresa $ 216.67 Bliss Mark $1,123.34 McCoy Michael $ 936.33 Bautista Amalia $ 81.91 Bean Jr James I $ 210.87 Born John $ 861.98 Brennan Eileen F. $ 181.17 Duran Julio $ 192.01 Fissenden Lawrence P $ 176.37 Gomez Boris $ 188.68 Johnson Jeffrey $ 624.93 Laguerre Anne G $ 117.76 Lindberg Berndt E $ 170.25 Meintsma Kathryn $ 305.60 Mistry Illa $ 284.25 Murley Rebecca $ 85.38 Nguyen Amy N $ 56.07 Ooley Adam C $ 90.99 |
Rooney Robert J. $ 63.53 Sabic Tereza $ 27.88 Scouton Patricia A $ 80.82 Springer James A $ 76.49 Stewart Jack D $ 323.88 Sutherlin Todd $ 487.28 Swenson Gregory $ 633.79 Teoh Clifford $ 647.08 Tyburski Karen $ 337.98 Vanarsdale Timothy L $ 48.98 Williams Denny L $ 112.18 Winders Patricia L $ 61.21 Mack Aggie $ 135.08 Mendez Rafael $ 446.86 Brown Roland $ 554.46 Hanson Ilene A $ 132.66 Hass Katherine A $ 123.31 Panuganti Vijayasri $ 166.80 Pless Nina M $ 58.07 Nguon Sokha $ 110.47 Capece Brian $ 349.39 Hanley Steven $ 584.17 Duffy James $ 763.93 Bot Marc $ 896.45 Bergquist Jonathan $ 386.20 Croci Steven $3,008.25 Horkey Natasha $ 105.39 Martinez Lisa $ 609.11 Quinn Patricia $ 326.29 Vela Juan $ 373.92 Wathen Peggy $ 9.83 Watson Gisela $ 28.49 White William $ 19.66 Bennett Michael $4,334.80 Caneda Jorge $ 561.89 Cielinski Carrie $ 285.85 Duckett Tammie $ 939.51 Koprowski Janet $2,590.23 Leblanc Ronald $1,521.94 Robertson Tammy $ 93.24 Schmidt Jennifer $ 202.93 Singh Sarwesh $ 440.24 Smith Johnnie $ 68.57 Stephenson Marie $ 65.00 Takock Aykham $ 227.72 Talbot Connie $ 471.05 |
Tool Sandra $ 840.78 Wei Kuo-Shiun $4,630.44 Carrillo Jr. Oscar $ 703.96 Josef Corazon $ 382.88 Khao Sarith $ 232.73 Roberts Barbara $1,278.94 Vennes Robert $2,278.61 Zhong Sheng-Ping $2,054.13 Miller Connie $1,531.31 Miller Paul $1,573.04 Jertson John $ 266.33 Colonna Douglas $ 310.94 Markle Charlotte $ 287.02 Flores Anita $ 130.32 Oza Paritosh $ 276.74 |
Special Year 2000 Contribution
Pursuant to Section 3.8, during the 2000 Plan Year, the Participating Employers made a special contribution on behalf of certain Participants (as listed below) in the amounts as indicated:
Participants Receiving Amount of Special Special 2000 Contribution 2000 Contribution ------------------------- ----------------- Poublon John A. $ 123.42 O'Mara Robert J. $ 122.92 Hauer Lillian R. $ 259.15 Paige Corrine F. $ 213.16 Carpenter Flo $ 129.82 Wetherbee William A. $ 147.18 Greer David A. $ 7.54 Randall Bryan L. $ 94.76 Hebert Charles B. $ 131.84 Bennett Ronald W. $ 138.69 Chow Stephen Y. $ 262.10 Silveira Rachelle L. $1,151.11 Oukaroune Souphaly $ 10.64 Fedie Byron $ 25.12 |
Special Contribution for Certain Former Employees of Cardiac Pathways
Pursuant to Section 3.8, the Participating Employers will make, in 2002, a special contribution on behalf of each Participant who (i) formerly participated in the Cardiac Pathways Corporation 401(k) Plan (the "Cardiac Plan"), (ii) earned in the aggregate less than $60,000 in 2001 from Boston Scientific Corporation and Cardiac Pathways Corporation, and (iii) was actively employed by Boston Scientific Corporation as of the last day of the Plan Year. Such contribution for each eligible Participant shall equal 35% of such Participant's "projected elective deferral amount". For purposes of this paragraph, "projected elective deferral amount" means the amount that the Participant would have deferred under the Cardiac Plan from August 8, 2001 through December 31, 2001 if the Cardiac Plan had not been terminated and if the Participant's elective deferral election under the Cardiac Plan as of August 7, 2001 had remained the same for the remainder of the year.
FORM OF
BOSTON SCIENTIFIC CORPORATION
401(k) RETIREMENT SAVINGS PLAN
FIRST AMENDMENT
Pursuant to Section 10.1 of the Boston Scientific Corporation 401(k) Retirement Savings Plan as amended and restated effective January 1, 2001 (the "Plan"), Boston Scientific Corporation hereby amends the Plan, effective January 1, 2003, as follows:
1. Section 3.1 is amended by deleting the last sentence thereof and by replacing it with the following:
"Elective Contributions for any pay period in a Plan Year may not be less than 1 percent of the Participant's Compensation for such pay period and the maximum amount of Elective Contributions for any pay period shall be the least of:
(a) 25 percent of the Participant's Compensation for such pay period;
(b) the maximum amount permitted under Article 11; and
(c) any further limit placed on Highly Compensated Employees by the Committee in its discretion in anticipation of satisfying the actual deferral percentage or actual contribution percentage limits described in Article 11.
In addition, effective January 1, 2003, Participants who have attained
age 50 before the close of a Plan Year shall be eligible to have
catch-up Elective Contributions made on their behalf for the Plan Year
in accordance with, and subject to, the limitations of Code section
414(v). Such catch-up Elective Contributions shall not be taken into
account for purposes of compliance by the Plan with the required
limitations of Code sections 402(g) and 415. The Participating
Employers will not make Matching Contributions on account of catch-up
Elective Contributions."
2. Section 3.3 (a) is amended by deleting the last sentence thereof and by replacing it with the following:
"The amount of Matching Contributions made by a Participating Employer for the period shall be equal to (i) 100% of the Elective Contributions (excluding catch-up Elective Contributions) made on behalf of the Participant for the period which do not exceed 2% of the Participant's Compensation for such period, plus (ii) 50% of the Elective Contributions (excluding catch-up Elective Contributions) made on behalf of the Participant for the period which exceed 2% but do not exceed 4% of the Participant's Compensation for such period."
3. Section 4.3(a) is amended by adding the following to the end thereof:
"Notwithstanding the foregoing, all investments under the Plan are subject to the rules and limitations contained in the prospectus or other documents that describe the investment."
4. Section 5.5 is amended by deleting paragraph (c) and replacing it with the following:
"(c) If a Participant forfeits any part of his or her Accounts under paragraph (a) above, the amount of the forfeiture will be applied, first, toward any restoration of any amount previously forfeited as required under paragraph (a) above, and then, toward either (i) the payment of reasonable expenses of administering the Plan, or (ii) the Matching Contributions required to be made to the Plan under Section 3.3, as determined by the Committee."
5. Section 6.6 is amended by deleting the first sentence in the last paragraph and replacing it with the following:
"For purposes of this Section, a Participant's Accounts will be considered to be valued in excess of $5,000 if the value of his or her Accounts (excluding any Rollover Contributions and any earnings thereon) exceeds such amount at the time of the distribution in question."
6. Section 6.6 is further amended by adding the following to the end thereof:
"Notwithstanding the foregoing, periodically the Committee will distribute terminated Participants' Accounts that no longer have a value in excess of $5,000."
7. Section 6.8 is amended by adding the following to the end thereof:
"With respect to distributions under the Plan made for calendar years beginning on or after January 1, 2003, the Plan will apply the minimum distribution requirements of Code section 401(a)(9) in accordance with the Final and Temporary Regulations that were issued on April 17, 2002."
8. Section 8.2 is amended by deleting the first sentence in the last paragraph and replacing it with the following:
"A Participant's Accounts will be considered to be valued in excess of $5,000 if the value of such Accounts (excluding Rollover Contributions and any earnings thereon) exceeds such amount at the time of the distribution in question."
9. Section 8.2 is further amended by adding the following to the end thereof:
"Notwithstanding the foregoing, periodically the Committee will distribute terminated Participants' Accounts that no longer have a value in excess of $5,000."
10. Article 9 is amended by adding a new Section 9.8 to read as follows:
"9.8 Expenses of Plan. The Committee may direct the Trustee to pay from the Trust any or all expenses of administering the Plan, to the extent such expenses are reasonable. The Committee will determine what constitutes a reasonable expense of administering the Plan, and whether such expenses shall be paid from the Trust. Any such expenses not paid out of the Trust shall be paid by the Company; provided, however, that to the extent permitted by ERISA, the Committee may direct the Trustee to reimburse the Company out of the Trust for a reasonable expense of administering the Plan which is paid by the Company prior to a determination with respect to such expense."
IN WITNESS WHEREOF, Boston Scientific Corporation has caused this amendment to be executed in its name and on its behalf this ________ day of ____________________, 2002.
BOSTON SCIENTIFIC CORPORATION
By: _______________________________
Title: ____________________________
.
.
.
EXHIBIT 12.1
BOSTON SCIENTIFIC CORPORATION
STATEMENT OF COMPUTATION OF RATIOS OF EARNINGS TO FIXED CHARGES (Unaudited)
(In millions)
Year Ended December 31, --------------------------------------------------- 2002 2001 2000 1999 1998 --------------------------------------------------- Fixed charges: Interest expense and debt issuance costs $ 43 $ 60 $ 70 $ 122 $ 74 Interest portion of rental expense 11 12 15 15 16 --------------------------------------------------- Total fixed charges $ 54 $ 72 $ 85 $ 137 $ 90 =================================================== Earnings: Income (loss) before income taxes and cumulative effect of change in accounting $ 549 $ 44 $ 527 $ 562 ($ 275) Fixed charges per above 54 72 85 137 90 Net distributed/(undistributed) equity in earnings of equity investees (13) 13 (1) Less: capitalized interest 1 4 --------------------------------------------------- Total earnings, as adjusted $ 603 $ 103 $ 625 $ 697 ($ 189) =================================================== Ratio of earnings to fixed charges 11.21 1.41 7.31 5.09 =================================================== Coverage deficiency(1) ($ 279) ====== Supplemental pro forma coverage deficiency(2) ($ 346) ====== |
(1) Includes noncash special charges of $646 million recorded in connection with the acquisition of Schneider Worldwide and other merger-related initiatives.
(2) Reflects the coverage deficiency as if the acquisition of Schneider Worldwide occurred at the beginning of 1998, with pro forma adjustments to give effect to amortization of intangibles, an increase in interest expense on acquisition financing and certain other adjustments.
.
.
.
Exhibit 13.1
2 0 0 2
CONSOLIDATED FINANCIAL STATEMENTS
BOSTON SCIENTIFIC AND SUBSIDIARIES
FINANCIAL TABLE OF CONTENTS Management's discussion and analysis of financial condition and results of operations 2 Consolidated statements of operations ............................................... 17 Consolidated balance sheets ......................................................... 18 Consolidated statements of stockholders' equity ..................................... 20 Consolidated statements of cash flows ............................................... 21 Notes to consolidated financial statements .......................................... 22 Report of independent auditors ...................................................... 48 Five-year selected financial data ................................................... 49 Quarterly results of operations ..................................................... 50 Market for the Company's common stock and related matters ........................... 51 |
(PHOTOS)
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
Boston Scientific Corporation (Boston Scientific or the Company) is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. The Company's mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare. The Company's approach to innovation combines internally developed products and technologies with those obtained externally through strategic acquisitions and alliances.
The Company's products are used in a broad range of interventional medical specialties, including interventional cardiology, peripheral intervention, neurovascular intervention, electrophysiology, vascular surgery, gastroenterology, gynecology, oncology and urology.
RESULTS OF OPERATIONS
FINANCIAL SUMMARY
YEARS ENDED DECEMBER 31, 2002 AND 2001
Net sales for the year ended December 31, 2002 were $2,919 million as compared
to $2,673 million in 2001. For the year ended December 31, 2002, the impact of
foreign currency fluctuations was not material. The reported net income for 2002
was $373 million, or $0.90 per share (diluted), as compared to a reported net
loss of $54 million, or $0.13 per share, in 2001. The reported results for 2002
include net after-tax charges of $40 million, which include provisions for:
purchased research and development primarily associated with the acquisitions of
Enteric Medical Technologies, Inc. (EMT) and Smart Therapeutics, Inc. (Smart);
costs associated with the Company's recently completed global operations plan;
an endowment to fund a newly created philanthropic foundation; special credits
for net amounts received in connection with settlements of litigation related to
rapid exchange catheter technology; and a reduction in income tax expense as a
result of a tax refund of previously paid taxes. The reported results for 2001
include after-tax charges of $377 million, which include provisions for:
purchased research and development related to acquisitions consummated in 2001;
costs associated with the Company's global operations plan; a provision for
excess inventory due to declining demand for the NIR(R) coronary stent
technology; and a write-down of intangible assets related to discontinued
technology platforms. Exclusive of these charges, net income for 2002 was $413
million, or $1.00 per share (diluted), as compared to net income of $323
million, or $0.80 per share (diluted), in 2001.
NET SALES
United States (U.S.) revenues increased approximately 10 percent to $1,756 million during 2002. U.S. revenues increased primarily due to revenue growth in the Company's Endosurgery product lines, increased sales of the Cutting Balloon(R) catheter, and the launch of the Company's internally developed Express2(TM) coronary stent in the U.S., offset by decreases in NIR(R) coronary stent sales.
International revenues increased approximately 8 percent to $1,163 million during 2002. The increase in international revenues for the year ended December 31, 2002 was primarily due to growth in the Company's Endoscopy product lines and increased sales of coronary stents within the Company's Europe and Inter-Continental operating segments, partially offset by decreases in NIR(R) coronary stent sales in Japan.
Worldwide coronary stent sales declined approximately 8 percent to $318 million during 2002 due to the lack of physician acceptance of the NIR(R) coronary stent platform and competitive product launches. In September 2002, the Company launched its Express2 coronary stent system in the U.S. The product has been well received in the market, increasing the Company's domestic coronary stent market share to greater than 20 percent during the fourth quarter of 2002. The Company anticipates the launch of its Express2 coronary stent system in Japan in the third quarter of 2003.
2
BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following table provides sales by region and relative change on an actual and constant foreign currency basis for the years ended December 31, 2002 and 2001, respectively.
DECEMBER 31, CHANGE ---------------------- ------------------------ AT AT ACTUAL CONSTANT CURRENCY CURRENCY (in millions) 2002 2001 BASIS BASIS ------ ------ ------ ------ United States $1,756 $1,598 10% 10% Europe 442 365 21% 15% Japan 494 522 (5%) (3%) Inter-Continental 227 188 21% 27% ------ ------ ------ ------ WORLDWIDE $2,919 $2,673 9% 9% ====== ====== ====== ====== |
The following table provides worldwide sales by division and relative change on an actual and constant foreign currency basis for the years ended December 31, 2002 and 2001, respectively.
DECEMBER 31, CHANGE ---------------------- ----------------------- AT AT ACTUAL CONSTANT CURRENCY CURRENCY (in millions) 2002 2001 BASIS BASIS ------ ------ ------ ------ SCIMED $1,709 $1,608 6% 6% EPT 101 82 23% 22% Target 169 151 12% 11% ------ ------ ------ ------ CARDIOVASCULAR $1,979 $1,841 7% 8% Medi-tech $ 231 $ 212 9% 11% Endoscopy 513 451 14% 13% Urology 196 169 16% 16% ------ ------ ------ ------ ENDOSURGERY $ 940 $ 832 13% 13% ------ ------ ------ ------ WORLDWIDE $2,919 $2,673 9% 9% ====== ====== ====== ====== |
The Company's international operating regions and divisions are managed on a constant currency basis, while market risk from changes in currency exchange rates is managed at the corporate level.
GROSS PROFIT
Gross profit increased to $2,049 million, or 70.2 percent of net sales, in 2002 from $1,754 million, or 65.6 percent of net sales, in 2001. The increase in gross profit in 2002 was primarily due to the increase in net sales, a $33 million reduction in costs related to the global operations plan and a $49 million provision recorded in 2001 for excess NIR(R) coronary stent inventories. Excluding these charges, gross profit percentage improved to 71.2 percent in 2002 from 69.8 percent in 2001 due to operational cost improvements achieved through the Company's global operations plan and to shifts in the Company's product sales mix toward higher margin products, primarily the Express(TM) coronary stent, partially offset by higher margin revenue declines in Japan.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
Selling, general and administrative expenses as a percentage of net sales decreased to 34 percent in 2002 from 35 percent in 2001 and increased approximately $76 million to $1,002 million in 2002. The increase in expenses in 2002 is primarily attributable to costs incurred to expand and to strengthen the Company's SCIMED field sales force in Europe and the Endosurgery field sales force in the U.S.
AMORTIZATION EXPENSE
Amortization expense decreased to $72 million in 2002 from $136 million in 2001 and decreased as a percentage of net sales to 2 percent from 5 percent. The decrease in 2002 is primarily a result of the adoption of Financial Accounting Standards Board Statement No. 142, Goodwill and Other Intangible Assets. As a result of adoption of Statement No. 142, the Company realized a pre-tax benefit of approximately $46 million of amortization reductions for goodwill and indefinite-lived intangible assets in 2002. This benefit was partially offset by amortization of intangible assets related to businesses acquired in 2002 and 2001. The decrease is also a result of a $24 million pre-tax write-down of intangible assets in the second quarter of 2001 related to discontinued technology platforms. During 2002, the Company completed
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
impairment reviews required by Statement No. 142; the Company did not recognize any impairment charges as a result of these reviews.
ROYALTIES
During 2002, royalties remained at approximately 1 percent of net sales. The Company expects that its royalty expenses will increase in 2003 primarily due to royalties payable on sales of the Company's TAXUS(TM) paclitaxel-eluting stent system.
RESEARCH AND DEVELOPMENT EXPENSES
Research and development expenses increased to $343 million in 2002 from $275 million in 2001 and increased as a percentage of net sales to 12 percent from 10 percent. The investment in research and development dollars reflects spending on new product development programs as well as regulatory compliance and clinical research. The increase in research and development expense during 2002 is primarily attributable to investment in the development of and clinical trials relating to the Company's TAXUS drug-eluting stent program and to investment in development programs acquired in connection with the Company's business combinations consummated in 2001, primarily related to the Embolic Protection, Inc. (EPI) Filterwire(TM) embolic protection device. The Company spent approximately $60 million and $30 million on its drug-eluting stent program in 2002 and 2001, respectively. In addition, the Company spent approximately $30 million and $10 million on its EPI Filterwire platform in 2002 and 2001, respectively. The Company currently anticipates research and development expenses as a percentage of net sales to remain at approximately 12 percent in 2003, including $100 million of estimated spending on its drug-eluting stent program and $15 million of spending on its EPI Filterwire platform.
The TAXUS clinical program is a series of studies designed to collect data on Boston Scientific's proprietary polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. Prior studies have demonstrated promising results by dramatically reducing restenosis. The proprietary polymer on the stent allows for controlled delivery of paclitaxel. Paclitaxel is a multifunctional microtubular inhibitor that controls platelets, smooth muscle cells and white blood cells, all of which are believed to contribute to restenosis. The Company initiated the TAXUS program in 1997.
The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. Clinical follow-up through 12 months continues to show favorable results. The TAXUS II trial studied the treatment of de novo coronary lesions and demonstrated both safety and efficacy using slow- and moderate-release formulations. Significant improvements were seen for clinical, angiographic and intravascular measures of stent performance compared with the bare metal control stent. The TAXUS III trial is a single-arm registry examining the feasibility of implanting up to two paclitaxel-eluting stents for the treatment of in-stent restenosis. The trial enrolled patients with complex vascular disease having recurrent occlusion in a stent, who have an increased probability of restenosis. Final six-month results from the TAXUS III trial confirmed safety and reported no stent thromboses. The TAXUS IV trial completed enrollment in August 2002 and nine-month follow-up is underway. TAXUS IV is a pivotal study designed to assess the safety and efficacy of the slow-release formulation to support regulatory filings for U.S. product commercialization; the Company plans on completing its Pre-Market Approval submission to the U.S. Food and Drug Administration (FDA) by the end of the second quarter of 2003. The TAXUS V trial has received conditional approval from the FDA to enroll patients and will study a higher risk patient population than TAXUS IV, including patients with disease in smaller vessels and longer lesions. TAXUS VI is studying patients with complex coronary artery disease and completed enrollment in January 2003. Boston Scientific has also initiated a transitional registry program (WISDOM) in a number of countries as part of a limited commercial launch of its TAXUS paclitaxel-eluting stent system. A European post-market registry (Milestone II) is expected to begin in the first quarter of 2003.
4 BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
INTEREST EXPENSE AND OTHER, NET
Interest expense decreased to $43 million in 2002 from $59 million in 2001. The overall decrease in interest expense is primarily attributable to lower average interest rates. Other, net, was an expense of approximately $18 million in 2002 and income of approximately $3 million in 2001. The change is primarily due to a charitable donation of $18 million made during 2002 to fund the newly created Boston Scientific Foundation and to net losses of approximately $3 million related to the Company's equity investment portfolio. The Boston Scientific Foundation is a philanthropic organization whose mission is to improve the health of individuals and communities, and to enhance educational opportunities.
TAX RATE
The Company's reported tax rate was 32 percent and 223 percent in 2002 and 2001, respectively. The decrease was primarily due to a reduction in net special charges in 2002 and a refund of previously paid taxes, which resulted in a reduction of income tax expense of $15 million. The Company's effective tax rate, excluding the impact of after-tax special charges and credits, decreased to 29 percent in 2002 from 30 percent in 2001. Management currently estimates that the 2003 effective tax rate will be approximately 27 percent. The decreases are primarily attributable to shifts in the mix between the Company's U.S. and international businesses. The effective tax rate could be positively or negatively impacted by changes in the geographic mix of the Company's income or by future acquisitions, if any.
YEARS ENDED DECEMBER 31, 2001 AND 2000
Net sales for the year ended December 31, 2001 were $2,673 million as compared to $2,664 million in 2000. Without the adverse impact of approximately $92 million arising from foreign currency fluctuations, net sales for 2001 increased 4 percent. The reported net loss for 2001 was $54 million, or $0.13 per share, as compared to reported net income of $373 million, or $0.91 per share (diluted), in 2000. The reported results for 2001 include after-tax charges of $377 million, which include a provision for purchased research and development related to acquisitions consummated in 2001; costs associated with the Company's global operations plan; a provision for excess inventory due to declining demand for the current NIR(R) coronary stent technology; and a write-down of intangible assets related to discontinued technology platforms. The reported results for 2000 include after-tax charges of $47 million, which include costs associated with the Company's global operations plan and a provision for excess NIR(R) coronary stent inventory. Exclusive of these charges, net income for 2001 was $323 million, or $0.80 per share (diluted), as compared to net income of $420 million, or $1.03 per share, in 2000.
NET SALES
U.S. revenues increased approximately 1 percent to $1,598 million during 2001, while international revenues decreased approximately 1 percent to $1,075 million. U.S. revenues increased due to revenue growth in the Company's product lines, including revenue generated by businesses acquired in 2001, offset by decreases in coronary stent sales. International revenues were negatively impacted by approximately $92 million of foreign exchange fluctuations. The decrease in international revenues was also due to declines in NIR(R) coronary stent sales. The reductions to international sales were partially offset by growth in the Company's product lines, including sales of products available through acquisitions, and the launch of the Company's internally developed Express(TM) coronary stent in European and other international markets.
GROSS PROFIT
Gross profit decreased to $1,754 million and 65.6 percent of net sales in 2001 from $1,832 million and 68.8 percent of net sales in 2000. The decline in gross profit in 2001 is primarily due to a pre-tax provision recorded in 2001 of $49 million for excess NIR(R) coronary stent inventory. The excess position was driven primarily by declining demand for the NIR(R) coronary stent technology. The Company recorded a pre-tax provision of $5 million for excess NIR(R) coronary stent inventory in 2000.
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MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Gross profit for the year ended December 31, 2001 was also negatively impacted by $62 million of pre-tax expenses associated with the Company's global operations plan, as compared to $11 million of such expenses in 2000. Excluding these charges, the gross profit percentage improved to 69.8 percent in 2001 from 69.4 percent in 2000 due to operational cost improvements and the Company's hedging activities.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
Selling, general and administrative expenses as a percentage of net sales increased to 35 percent of sales in 2001 from 33 percent in 2000 and increased approximately $59 million to $926 million in 2001. The increase in expenses in 2001 is primarily attributable to costs associated with the businesses acquired in 2001 and incremental costs incurred to strengthen the Company's field sales force.
AMORTIZATION EXPENSE
Amortization expense increased to $136 million in 2001 from $91 million in 2000 and increased as a percentage of net sales to 5 percent from 3 percent. The increase in 2001 is primarily a result of a $24 million write-down of intangible assets related to discontinued technology platforms and amortization of intangible assets related to businesses acquired in 2001.
ROYALTIES
During 2001, royalties remained at approximately 1 percent of net sales.
RESEARCH AND DEVELOPMENT EXPENSES
Research and development expenses increased to $275 million in 2001 from $199 million in 2000 and increased as a percentage of net sales to 10 percent from 7 percent. The increase in research and development is primarily due to increased funding for the development of, and the clinical trials related to, new products, including the Company's Express(TM) coronary stent platform, its TAXUS(TM) drug-eluting stent program, its carotid program and programs acquired in connection with the Company's business combinations consummated in 2001.
INTEREST EXPENSE AND OTHER, NET
Interest expense decreased to $59 million in 2001 from $70 million in 2000. The overall decrease in interest expense is primarily attributable to lower average interest rates. Other income, net, decreased to approximately $3 million in 2001 from approximately $17 million in 2000. The change is primarily due to net gains recognized on sales of available-for-sale securities in 2000 and to net gains recorded on derivative financial instruments in 2000.
TAX RATE
The Company's reported tax rate was 223 percent and 29 percent in 2001 and 2000, respectively. The increase was primarily due to an increase in special charges in 2001. The Company's effective tax rate, excluding the impact of in-process research and development related to the 2001 acquisitions and restructuring-related charges, was 30 percent for both 2001 and 2000.
GLOBAL OPERATIONS STRATEGY UPDATE
During 2000, the Company approved and committed to a global operations plan consisting of a series of strategic initiatives designed to increase productivity and enhance innovation. The plan includes manufacturing process and supply chain programs and a plant optimization initiative. The plant optimization initiative has created a better allocation of the Company's resources by forming a more effective network of manufacturing and research and development facilities.
During the second quarter of 2002, the Company substantially completed the plant optimization initiative. The Company recorded pre-tax expenses of approximately $23 million as
6 BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
cost of sales in 2002 primarily related to transition costs associated with the plant optimization plan and to abnormal production variances related to underutilized plant capacity. In addition, during the second quarter of 2002, the Company recorded a $6 million pre-tax charge to cost of sales for severance and related costs associated with its global operations strategy. The approximately 250 affected employees included manufacturing, manufacturing support and management employees. The reductions resulted from the Company's continued achievement of operational efficiencies within its plant network and its continued effort to manage costs. During 2001, the Company recorded pre-tax expenses of approximately $62 million as cost of sales, primarily related to transition costs and accelerated depreciation on fixed assets whose useful lives were reduced as a result of the initiative. During 2000, the Company recorded a $58 million pre-tax special charge for severance and related costs associated with the displacement of the approximately 1,700 manufacturing, manufacturing support and management employees under the plan. In addition, the Company recorded pre-tax expenses of $11 million during 2000 related to transition costs and accelerated depreciation. At December 31, 2002, the Company had made cash outlays of approximately $160 million since the inception of the global operations strategy and had approximately $4 million of accrued severance and related costs remaining associated with its global operations strategy initiatives. The accrued costs are expected to be paid by the end of 2003.
During 2002, the Company achieved pre-tax operating savings, relative to the
plan's base year of 1999, of approximately $220 million. The Company estimates
that the global operations plan will achieve future pre-tax operating savings,
relative to the base year, of approximately $250 million in annualized savings
in 2003 and thereafter. These savings will be realized primarily as reduced cost
of sales. Savings to date have been partially offset by price erosion and the
effects of foreign currency fluctuations relative to the base year.
Additionally, the Company continues to use the majority of these savings to fund
its increased investment in research and development.
LITIGATION SETTLEMENTS
During the third quarter of 2002, the Company entered into an agreement to settle a number of patent infringement lawsuits between the Company and Medtronic, Inc. (Medtronic). The settlement resolved the Company's damage claims against Medtronic arising out of a German court case and a U.S. arbitration proceeding involving Medtronic rapid exchange stent delivery systems and angioplasty dilatation balloon catheters. In accordance with the settlement agreement, during the third quarter of 2002, Medtronic paid the Company approximately $175 million to settle damage award claims for past infringement. In addition, during the third quarter of 2002, the Company recorded a net charge of approximately $76 million for settlement of litigation related to rapid exchange catheter technology.
PURCHASED RESEARCH AND DEVELOPMENT
During 2002, the Company paid approximately $187 million in cash to acquire Smart Therapeutics, Inc. (Smart), BEI Medical Systems Company, Inc. and Enteric Medical Technologies, Inc. (EMT). During 2001, the Company paid approximately $620 million in cash and issued approximately 1.9 million shares valued at $40 million to acquire RadioTherapeutics Corporation, Cardiac Pathways Corporation, Interventional Technologies, Inc. (IVT), Quanam Medical Corporation, Catheter Innovations, Inc. and Embolic Protection, Inc. (EPI). These acquisitions are intended to strengthen the Company's leadership position in interventional medicine. The acquisitions were accounted for using the purchase method of accounting. The consolidated financial statements include the operating results for each acquired entity from its respective date of acquisition. Pro forma information is not presented, as the acquired companies' results of operations prior to their date of acquisition are not material, individually or in the aggregate, to the Company.
The purchase price recorded for each acquisition has been allocated to the assets acquired and liabilities assumed based on their fair values at the date of acquisition. The estimated excess of purchase price over the fair value of the net tangible assets acquired was allocated to identifiable intangible assets, as valued by an independent appraiser using information and assumptions provided by management. Based upon these
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MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
valuations, the Company recorded charges of approximately $85 million in 2002 and $282 million in 2001 to account for purchased research and development. The valuation of purchased research and development, for which management is primarily responsible, represents the estimated fair value at the date of acquisition related to in-process projects. As of the date of acquisition, the in-process projects had not yet reached technological feasibility and had no alternative future uses. The primary basis for determining the technological feasibility of these projects is obtaining regulatory approval to market the product. Accordingly, the value attributable to these projects, which had not yet obtained regulatory approval, was expensed in conjunction with the acquisition. If the projects are not successful or completed in a timely manner, the Company may not realize the financial benefits expected for these projects.
The income approach was used to establish the fair values of purchased research and development. This approach establishes fair value by estimating the after-tax cash flows attributable to the in-process project over its useful life and then discounting these after-tax cash flows back to a present value. Revenue estimates were based on estimates of relevant market sizes, expected market growth rates, expected trends in technology and expected product introductions by competitors. In arriving at the value of the in-process research and development projects, the Company considered, among other factors, the in-process project's stage of completion, the complexity of the work completed as of the acquisition date, the costs already incurred, the projected costs to complete, the contribution of core technologies and other acquired assets, the expected introduction date and the estimated useful life of the technology. The discount rate used to arrive at a present value as of the date of acquisition was based on the time value of money and medical technology investment risk factors. For the purchased research and development programs acquired in connection with the 2002 acquisitions, risk-adjusted discount rates ranging from 17 percent to 26 percent were utilized to discount the projected cash flows. For the purchased research and development programs acquired in connection with the 2001 acquisitions, risk-adjusted discount rates ranging from 16 percent to 28 percent were utilized to discount the projected cash flows. The Company believes that the estimated purchased research and development amounts so determined represent the fair value at the date of acquisition and do not exceed the amount a third party would pay for the projects.
The most significant projects, relative to the purchased research and development charge recorded in connection with the acquisitions consummated in 2002, are EMT's Enteryx(TM) technology for the treatment of gastroesophageal reflux disease (GERD) and Smart's atherosclerosis stent, which collectively represent approximately 82 percent of the 2002 in-process value. Enteryx is a patented liquid polymer for the treatment of GERD. The atherosclerosis stent is a self-expanding nitinol stent designed to treat narrowing of the arteries around the brain. As of the date of acquisition, the projects were expected to be completed and the products commercially available on a worldwide basis within one to four years, with an estimated cost to complete of approximately $2 million to $13 million.
The most significant projects, relative to the purchased research and development charge recorded in connection with the acquisitions consummated in 2001, are IVT's next-generation Cutting Balloon(R) catheter, the next-generation Infiltrator(R) transluminal drug-delivery catheter and EPI's next-generation embolic protection devices, which collectively represent approximately 63 percent of the 2001 in-process value. The Cutting Balloon is a novel balloon angioplasty device with mounted scalpels that relieve stress in the artery, reducing the force necessary to expand the vessel. This contributes to less inadvertent arterial trauma and injury as compared to standard balloon angioplasty. The Infiltrator transluminal drug-delivery catheter is designed to deliver therapeutic agents directly into the wall of the artery with high levels of efficiency. The embolic protection devices are filters that are mounted on a guidewire and are used to capture embolic material that is dislodged during cardiovascular interventions. As of the date of acquisition, the projects were expected to be completed and the products to be commercially available on a worldwide basis within one to four years, with an estimated cost to complete of approximately $30 million to $45 million.
The Company's acquired research and development projects are generally progressing in line with the estimates set forth above, with the exception of IVT's next-generation Infiltrator transluminal drug-delivery catheter project. Due to alternative
8 BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
drug-delivery products available to the Company, the Company has reduced its future revenue projections for this product. The Company expects to continue to pursue this and other research and development projects acquired in connection with its business combinations and believes it has a reasonable chance of completing the projects.
OUTLOOK
The worldwide coronary stent market is dynamic and highly competitive with significant market share volatility. The introduction of drug-eluting stents is likely to have a significant impact on the market size for coronary stents and on the distribution of market share across the industry. The Company believes drug-eluting stent technology represents one of the largest market opportunities in the history of the medical device industry. It is estimated that the annual worldwide market for coronary stents, including drug-eluting stents, may grow to $5 billion by 2005, compared to approximately $2.2 billion today. Although the Company believes it is positioned to be one of only two early entrants in this market, uncertainties exist about the rate of development and size of this new market.
The Company believes it is poised to take advantage of the drug-eluting stent opportunity for a variety of reasons, including its more than five years of scientifically rigorous research and development, the promising clinical results of its TAXUS(TM) program, the combined strength of the components of its technology, its overall market leadership, and the largest sales force in interventional cardiology. In addition, in order to capitalize on this opportunity, the Company is making significant investments in its sales, clinical and manufacturing capabilities.
Recognizing the promise and benefits of drug-eluting stents, physicians are expected to rapidly adopt this new technology. In addition, initial reimbursement rates have already been set in the United States.
The Company's success with drug-eluting stents, and its ability to improve operating margins, could be adversely affected by more gradual physician adoption rates, changes in reimbursement policies, delayed or limited regulatory approvals, unexpected variations in clinical results, the earlier availability of a competitor's technology, third-party intellectual property, the outcome of litigation and the availability of inventory to meet customer demand. A more gradual physician adoption rate may limit the number of procedures in which the technology may be used and the price at which institutions may be willing to purchase the technology. Together, these and other factors contribute to the uncertainty surrounding the evolution of the drug-eluting stent market and the Company's position in it.
It is expected that one of the Company's competitors will launch a drug-eluting stent into the U.S. market in the first half of 2003, while the Company's drug-eluting stent product is expected to be launched in the U.S. in late 2003. In addition, several of the Company's competitors are expected to launch bare metal stent products into the U.S. market during 2003. Until the Company launches its drug-eluting stent product, it is likely that its U.S. coronary stent business will be subject to significant share and price pressure; however, the Company expects to achieve growth in its U.S. coronary stent business in 2003 as compared to 2002. During the first quarter of 2003, the Company received CE Mark approval for its TAXUS paclitaxel-eluting stent system, and launched the product in Europe and other international markets. The Company plans to launch its drug-eluting stent product in Japan in early 2005, subject to regulatory approvals.
As the health care environment continues to undergo rapid change, management expects that it will continue to focus on strategic initiatives and make additional investments in existing relationships. During 2002 and 2001, the Company consummated several business acquisitions and strategic alliances. Management believes it has developed a sound plan to integrate these businesses. The failure to successfully integrate these businesses could impair the Company's ability to realize the strategic and financial objectives of these transactions. In connection with these and other acquisitions consummated during the last five years, the Company has acquired numerous in-process research and development platforms. As the Company continues to undertake strategic initiatives, it is reasonable to assume that it will acquire additional in-process research and development platforms.
Uncertainty remains with regard to future changes within the health care industry. The trend toward managed care and
BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
economically motivated and more sophisticated buyers in the U.S. may result in continued pressure on selling prices of certain products and compression of gross margins. Further, the U.S. marketplace is increasingly characterized by consolidation among health care providers and purchasers of medical devices who prefer to limit the number of suppliers from which they purchase medical products. There can be no assurance that these entities will continue to purchase products from the Company.
International markets are also being affected by economic pressure to contain reimbursement levels and health care costs. The Company's profitability from its international operations may be limited by risks and uncertainties related to economic conditions in these regions, regulatory and reimbursement approvals, competitive offerings, infrastructure development, rights to intellectual property and the ability of the Company to implement its overall business strategy. Any significant changes in the competitive, political, regulatory, reimbursement or economic environment where the Company conducts international operations may have a material impact on revenues and profits, especially in Japan, given its high profitability relative to its contribution to revenues. The Company's Japan business is expected to be under continued pressure, particularly in coronary stents, due to competitive product offerings and the lack of physician acceptance of the NIR(R) coronary stent platform. The Company anticipates the launch of its Express(2)(TM) coronary stent system in Japan in the third quarter of 2003. Deterioration in the Japanese and/or emerging markets economies may impact the Company's ability to grow its business and to collect its accounts receivable in international markets. Additionally, the trend in countries around the world toward more stringent regulatory requirements for product clearance, changing reimbursement models and more vigorous enforcement activities has generally caused or may cause medical device manufacturers to experience more uncertainty, greater risk and higher expenses.
These factors may impact the rate at which the Company can grow. However, management believes that it is positioning the Company to take advantage of opportunities that exist in the markets it serves.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses. Actual results could differ from those estimates. The Company has formal accounting policies in place including those that address critical and complex accounting areas. Note A to the consolidated financial statements describes the significant accounting policies used in the preparation of the consolidated financial statements. The most significant areas involving management judgments and estimates are described below.
REVENUE RECOGNITION: The Company recognizes revenue from the sale of its products when the products are shipped to its customers unless a consignment arrangement exists. Revenue from consignment customers is recognized based on product usage indicating sales are complete. The Company allows its customers to return certain products for credit. The Company also allows customers to return defective or damaged products for credit or replacement. The Company's estimates for sales returns, rebates and discounts are based upon contractual commitments and historical trends and are recorded as a reduction to revenue.
INTANGIBLE ASSETS: Intangible assets are recorded at historical cost. Intangible assets acquired in a business combination, including purchased research and development, are recorded under the purchase method of accounting at their estimated fair values at the date of acquisition. The fair values of acquired intangible assets are determined by an independent appraiser using information and assumptions provided by management. Goodwill represents the excess purchase price over the fair value of the net tangible and intangible assets acquired.
The Company's intangible assets are amortized using the straight-line method over their useful lives, as applicable, as follows: patents, 3 to 20 years; licenses, 2 to 20 years; definite-lived core and developed technology, 3 to 25 years; other intangibles, various. In the first quarter of 2002, the Company
10
BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ceased amortization of its excess of cost over net assets acquired (goodwill) and certain other indefinite-lived intangible assets in accordance with Statement No. 142. The Company had $827 million and $765 million of net intangible assets that are subject to amortization at December 31, 2002 and 2001, respectively, and $1,540 million and $1,299 million of goodwill and other indefinite-lived intangible assets at December 31, 2002 and 2001, respectively.
The Company reviews intangible assets at least annually to determine if any adverse conditions exist that would indicate impairment. Conditions that would trigger an impairment assessment include, but are not limited to, a significant adverse change in legal factors or business climate that could affect the value of an asset or an adverse action or assessment by a regulator. If the carrying amount of an asset exceeds the sum of its undiscounted cash flows, the carrying value is written down to fair value in the period identified. Fair value is calculated as the present value of estimated future cash flows using a risk-adjusted discount rate. Goodwill is reviewed at least annually for impairment utilizing the two-step business unit approach prescribed under Statement No. 142. Indefinite-lived intangible assets are reviewed at least annually for impairment by calculating the fair value of the intangible assets and comparing these amounts to the related carrying values.
INVENTORIES: Inventories are stated at the lower of first-in, first-out cost or market. Provisions for excess inventory are primarily based on management's estimates of forecasted sales levels. A significant decline in demand for the Company's products as compared to forecasted amounts may result in the recording of additional provisions for excess inventory in the future. Provisions for inventory located in the Company's manufacturing and distribution facilities are recorded as cost of sales. Generally, write-downs of consignment inventory are charged to selling, general and administrative expenses.
LEGAL COSTS: The Company is involved in various lawsuits, including patent infringement and product liability suits, from time to time in the normal course of business. In some cases, the claimants seek damages, as well as other relief, which, if granted, could require significant expenditures. The Company accrues costs of settlement, damages and, under certain conditions, costs of defense when such costs are probable and estimable. Otherwise, such costs are expensed as incurred. As of December 31, 2002, the potential exposure for litigation-related accruable costs is estimated to range from $4 million to $10 million. The Company's total accrual for litigation-related reserves as of December 31, 2002 and 2001 was approximately $4 million and $6 million, respectively. As of December 31, 2002, the range of loss for reasonably possible contingencies that can be estimated is not material.
INCOME TAXES: The Company utilizes the asset and liability method for accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
The Company has recognized net deferred tax assets aggregating $68 million at December 31, 2002 and $131 million at December 31, 2001. The assets relate principally to the establishment of inventory and product-related reserves, purchased research and development and net operating loss carryforwards. In light of the Company's historical financial performance, the Company believes that these assets will be substantially recovered.
In addition, the Company operates within multiple taxing jurisdictions and is subject to audit in these jurisdictions. These audits can involve complex issues, which may require an extended period of time to resolve. In management's opinion, adequate provisions for income taxes have been made for all years. The Company expects to settle some of these audits over the next several quarters. As these audits are settled the Company will adjust previous estimates for accrued taxes.
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MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
LIQUIDITY AND CAPITAL RESOURCES
Cash generated by operations provides a major source of funds for the growth of the Company, including working capital, additions to property, plant and equipment, acquisitions and strategic alliances. Cash provided by operating activities increased to $736 million in 2002 from $490 million in 2001. The increase is primarily due to the growth in the Company's earnings before special charges, cash received in connection with litigation settlements, changes in deferred income taxes and continued improvement of inventory management. In addition, the Company received approximately $107 million during 2002 in connection with the issuance of shares pursuant to its stock option and employee stock purchase plans. Cash proceeds during the period were primarily used to fund acquisitions, strategic alliances, capital expenditures and to reduce the Company's borrowings.
During 2002, the Company significantly improved its financial position by reducing its net debt (debt net of cash and cash equivalents) to $658 million at December 31, 2002 from $1,024 million at the end of 2001. As of December 31, 2002, net debt represented 19 percent of capital (total stockholders' equity plus total debt) as compared to 32 percent of capital as of December 31, 2001. Cash and cash equivalents totaled $277 million at December 31, 2002, compared to $180 million at December 31, 2001. The Company had $285 million and $275 million of working capital at December 31, 2002 and 2001, respectively. The Company's working capital position at December 31, 2002, relative to December 31, 2001, was affected by an increase in accrued liabilities, a reduction of short-term debt and increases in the Company's cash balances held at subsidiaries outside the U.S. The Company's accrued liabilities at December 31, 2002 include $195 million of acquisition obligations, which were paid in the first quarter of 2003.
The Company had approximately $88 million and $99 million of commercial paper outstanding at December 31, 2002 and 2001, respectively, at weighted average interest rates of 1.50 percent and 2.33 percent, respectively. In addition, the Company had approximately $113 million and $547 million in unsecured revolving credit facility borrowings outstanding at December 31, 2002 and 2001, respectively, at weighted average interest rates of 0.58 percent and 1.95 percent, respectively.
At December 31, 2002, the revolving credit facilities totaled approximately $1.6 billion, consisting of a $1 billion credit facility that terminates in May 2003 and a $600 million credit facility that terminates in August 2006. The revolving credit facilities also support the Company's commercial paper borrowings. The revolving credit facilities require the Company to maintain a specific ratio of consolidated total debt (as defined) to consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) (as defined) of less than or equal to 3.5 to 1. The ratio was approximately 1.1 to 1 at December 31, 2002 compared to 1.9 to 1 at December 31, 2001. In addition, the revolving credit facilities require the Company to maintain a specific ratio of consolidated EBITDA (as defined) to consolidated interest expense (as defined) of greater than or equal to 3.5 to 1. The ratio was approximately 19.6 to 1 at December 31, 2002 compared to 10.4 to 1 at December 31, 2001. The Company intends to refinance its $1 billion credit facility terminating in May 2003 with a new credit facility of up to $1 billion having similar terms and conditions.
In August 2002, the Company entered into a revolving credit and security facility providing for up to $200 million of additional borrowing capacity secured by the Company's domestic trade accounts receivable. The maximum amount available for borrowing under this facility changes based upon the amount of eligible receivables, concentration of eligible receivables and other factors. At December 31, 2002, $197 million was outstanding under this facility and bore interest at 1.89 percent. Certain significant changes in the quality of the Company's receivables may cause an amortization event under this facility. An amortization event may require the Company to immediately repay borrowings under the facility. The financing structure required the Company to create a wholly owned entity, which is consolidated by the Company. This entity purchases U.S. trade accounts receivable from the Company and then borrows from two third-party financial institutions using these receivables as collateral. The transactions remain on the Company's balance sheet because the Company has the right to prepay any borrowings outstanding, allowing the Company to retain effective control over the receivables. Accordingly, pledged receivables and the corresponding borrowings are included as trade accounts receivable, net and long-term debt, respectively, on the accompanying consolidated balance sheets.
12
BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The Company has the ability to refinance a portion of its short-term debt on a long-term basis through its revolving credit facilities. The Company expects a minimum of $320 million of its bank obligations will remain outstanding beyond the next twelve months and, accordingly, has classified this portion as long-term borrowings at December 31, 2002, compared to $471 million of bank obligations classified as long-term at December 31, 2001.
The Company had $500 million of senior notes (the Notes) outstanding at December 31, 2002. The Notes mature in March 2005, bear a semi-annual coupon of 6.625 percent, and are not redeemable prior to maturity or subject to any sinking fund requirements. During 2001, the Company entered into a fixed to floating interest rate swap to hedge changes in the fair value of the Notes, which the Company elected to terminate in October 2002. At the date of termination, the fair value of the swap and cash received was approximately $13 million. The Company will amortize the $13 million adjustment to the carrying amount of the Notes into earnings on a straight-line basis through the maturity date of the Notes. The carrying amount of the Notes was approximately $511 million and $485 million at December 31, 2002 and 2001, respectively.
During the first quarter of 2002, the Company repaid 6 billion Japanese yen (translated to approximately $45 million at the date of repayment and $46 million at December 31, 2001) of borrowings outstanding with a syndicate of Japanese banks. In addition, the Company had approximately 800 million Japanese yen (translated to approximately $6 million) at December 31, 2002 and 1 billion Japanese yen (translated to approximately $7 million) at December 31, 2001 of borrowings outstanding from a Japanese bank used to finance a facility construction project. The interest rate on the borrowings is 2.1 percent and semi-annual principal payments are due through 2012.
The Company has uncommitted Japanese credit facilities with several commercial banks, which provided for borrowings and promissory notes discounting of up to 14.5 billion Japanese yen (translated to approximately $122 million) at December 31, 2002 and up to 15 billion Japanese yen (translated to approximately $115 million) at December 31, 2001. There were $7 million in borrowings outstanding under the Japanese credit facilities at an interest rate of 1.38 percent at December 31, 2002, compared to $8 million in borrowings at an interest rate of 1.38 percent at December 31, 2001. At December 31, 2002, approximately $102 million of notes receivable were discounted at average interest rates of approximately 1.38 percent compared to $88 million of discounted notes receivable at average interest rates of approximately 1.38 percent at December 31, 2001.
Certain of the Company's 2001 and 2002 business combinations involve contingent consideration. These payments would be allocated to specific intangible asset categories or assigned to excess of cost over net assets acquired, as applicable, as if the consideration had been paid as of the date of acquisition. Payment of the additional consideration is generally contingent upon the acquired companies' reaching certain performance milestones, including achieving specified revenue levels, product development targets or obtaining regulatory approvals. At December 31, 2002, the Company had an accrual for acquisition obligations of $195 million that was paid during the first quarter of 2003. In addition, the maximum potential amount of future contingent consideration (undiscounted) that the Company could be required to make associated with its 2001 and 2002 business combinations is approximately $500 million, some of which may be payable in the Company's common stock. The milestones associated with this contingent consideration must be reached in certain future periods ranging from 2003 through 2007. The specified revenue levels associated with the maximum future contingent payments is approximately $800 million.
The Company has future minimum rental commitments under noncancelable capital and operating lease agreements of $176 million as of December 31, 2002. The related lease agreements expire on various dates over the next fifteen years. The Company expects to make payments of $41 million under its noncancelable capital and operating lease agreements during 2003.
The Company is authorized to purchase on the open market and in private transactions up to approximately 60 million shares of the Company's common stock. Stock repurchased would principally be used to satisfy the Company's obligations pursuant to its equity incentive plans, but may also be used for general corporate purposes, including acquisitions. As of
BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
December 31, 2002, a total of approximately 38 million shares of the Company's common stock have been repurchased. During the first quarter of 2003, the Company repurchased approximately 4.5 million shares at an aggregate cost of $189 million.
Additionally, the Company expects to incur capital expenditures of approximately $200 million during 2003. The Company expects that its cash and cash equivalents, marketable securities, cash flows from operating activities and borrowing capacity will be sufficient to meet its projected operating cash needs over the next twelve months, including capital expenditures, rental commitments, tax payments, stock repurchases, acquisition-related payments and other strategic initiatives.
MARKET RISK DISCLOSURES
The Company operates globally, and its earnings and cash flow are exposed to market risk from changes in currency exchange rates and interest rates. The Company addresses these risks through a risk management program that includes the use of derivative instruments. The program is operated pursuant to documented corporate risk management policies. The Company does not enter into any derivative transactions for speculative purposes. Gains and losses on derivative instruments substantially offset losses and gains on underlying hedged exposures. Furthermore, the Company manages its credit exposure to nonperformance on such derivative instruments by entering into contracts with a diversified group of major financial institutions to limit the amount of credit exposure to any one institution.
Currency risk consists primarily of foreign currency denominated firm commitments, forecasted foreign currency denominated intercompany and third-party transactions, and net investments in certain subsidiaries. The Company uses both non-derivative (primarily foreign currency denominated borrowings) and derivative instruments to manage its earnings and cash flow exposure to changes in currency exchange rates. The Company had currency derivative instruments outstanding in the notional amounts of $1,318 million and $864 million at December 31, 2002 and 2001, respectively.
The Company recorded $15 million of assets and $27 million of liabilities to recognize the fair value of these instruments at December 31, 2002, compared to $76 million of assets and no liabilities at December 31, 2001. A 10 percent appreciation in the U.S. dollar's value relative to the hedged currencies would increase the derivative instruments' fair value by $75 million and $70 million at December 31, 2002 and 2001, respectively. A 10 percent depreciation in the U.S. dollar's value relative to the hedged currencies would decrease the derivative instruments' fair value by $91 million and $70 million at December 31, 2002 and 2001, respectively. Any increase or decrease in the fair value of the Company's currency exchange rate sensitive derivative instruments would be substantially offset by a corresponding decrease or increase in the fair value of the hedged underlying asset, liability or cash flow.
The Company's earnings and cash flow exposure to interest rates consists of fixed and floating rate debt instruments that are denominated primarily in U.S. dollars and Japanese yen. The Company uses interest rate derivative instruments to manage its exposure to interest rate movements and to reduce borrowing costs by converting floating rate debt into fixed rate debt or fixed rate debt into floating rate debt. The Company had interest rate derivative instruments outstanding in the notional amounts of $63 million and $557 million at December 31, 2002 and 2001, respectively. The Company recorded an immaterial amount of other long-term liabilities to recognize the fair value of these instruments at December 31, 2002, compared to $15 million of other long-term liabilities at December 31, 2001. A 100 basis point change in global interest rates would not have resulted in a material change in the derivative instruments' fair values at December 31, 2002 or 2001. Any increase or decrease in the fair value of the Company's interest rate sensitive derivative instruments would be substantially offset by a corresponding decrease or increase in the fair value of the hedged underlying liability.
14
BOSTON SCIENTIFIC AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
LEGAL MATTERS
The Company is involved in various legal proceedings, including patent infringement and product liability suits, from time to time in the normal course of business. In management's opinion, the Company is not currently involved in any legal proceeding other than those specifically identified in Note L to the consolidated financial statements contained herein, which, individually or in the aggregate, could have a material effect on the financial condition, operations and/or cash flows of the Company. Additionally, legal costs associated with asserting the Company's patent portfolio and defending against claims that the Company's products infringe the intellectual property of others are significant, and legal costs associated with non-patent litigation and compliance activities are rising. Depending on the prevalence, significance and complexity of these matters, the Company's legal provision could be adversely affected in the future.
Further, product liability claims against the Company may be asserted in the future related to events not known to management at the present time. As a result of current economic factors impacting the insurance industry, during the third quarter of 2002, the Company elected to become substantially self-insured with respect to general and product liability claims. Losses for claims in excess of the limits of purchased insurance would be recorded at the time and to the extent they are probable and estimable. Management believes that the Company's risk management practices, including limited insurance coverage, are reasonably adequate to protect against anticipated general and product liability losses. However, unanticipated catastrophic losses could have a material adverse impact on the Company's financial position, results of operations and liquidity.
CAUTIONARY STATEMENTS FOR PURPOSES OF THE SAFE HARBOR PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This report contains forward-looking statements. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this statement for the express purpose of availing itself of the protections of the safe harbor with respect to all forward-looking statements. Forward-looking statements discussed in this report include, but are not limited to, statements with respect to, and the Company's performance may be affected by:
- volatility in the coronary stent market, competitive offerings and the timing of submission for and receipt of regulatory approvals to market TAXUS(TM) drug-eluting stents and other coronary and peripheral stent platforms;
- the Company's ability to launch the Express(2)(TM) coronary stent in the Japanese market in the third quarter of 2003 and the TAXUS drug-eluting stent in the U.S. and Japanese markets in late 2003 and early 2005, respectively;
- the impact and timing of the introduction of drug-eluting stents on the size and distribution of share within the coronary stent market in the U.S. and around the world;
- the Company's ability to capitalize on the opportunity in the drug-eluting stent market for significant growth in revenue and earnings and to supply sufficient inventory to meet customer demand;
- the Company's ability to achieve growth in its worldwide and domestic coronary stent business in the face of competitive pressure and the introduction of drug-eluting stents;
- the continued decline in NIR(R) coronary stent sales in Japan and changes in the mix of the Company's coronary stent platforms;
- the development and introduction of competing or technologically advanced products by the Company's competitors;
- the Company's ability to achieve estimated operating savings and operating efficiencies from the global operations plan;
BOSTON SCIENTIFIC AND SUBSIDIARIES
- the ability of the Company to manage accounts receivable and gross margins and to react effectively to the changing managed care environment, reimbursement models and worldwide economic and political conditions;
- the Company's ability to integrate the acquisitions consummated in 2001 and 2002 and the Company's other strategic alliances;
- the Company's ability to generate anticipated revenues and other benefits associated with the 2001 and 2002 acquisitions and strategic alliances and to fund related contingent payments;
- management's decisions relating to investments in research and development at anticipated levels in 2003, including $100 million of spending on its drug-eluting stent program and $15 million of spending on its EPI Filterwire(TM) platform;
- the Company's ability to successfully complete planned clinical trials and to develop and launch products on a timely basis within cost estimates, including products resulting from purchased research and development;
- the Company's ability to position itself as one of two early entrants in the drug-eluting stent market and to take advantage of opportunities that exist in the markets it serves;
- the timing, size and nature of strategic initiatives, market opportunities and research and development platforms available to the Company and the ultimate success of these initiatives;
- the Company's ability to reduce its effective tax rate for 2003 to 27 percent, to settle tax audits favorably and to substantially recover its net deferred tax assets;
- the ability of the Company to meet its projected cash needs, to refinance expiring credit facilities and to maintain its borrowings beyond the next twelve months;
- risks associated with international operations;
- the potential effect of foreign currency fluctuations on revenues, expenses and resulting margins;
- the effect of litigation, risk management practices and compliance activities on the Company's loss contingency, legal provision and cash flow; and
- the impact of stockholder, patent, product liability, Federal Trade Commission, Medinol Ltd. and other litigation, as well as the ultimate outcome of the U.S. Department of Justice investigation.
Several important factors, in addition to the specific factors discussed in connection with each forward-looking statement individually, could affect the future results and growth rates of the Company and could cause those results and rates to differ materially from those expressed in the forward-looking statements contained in this report. These additional factors include, among other things, future economic, competitive, reimbursement and regulatory conditions, new product introductions, demographic trends, third-party intellectual property, financial market conditions and future business decisions of the Company and its competitors, all of which are difficult or impossible to predict accurately and many of which are beyond the control of the Company. Therefore, the Company wishes to caution each reader of this report to consider carefully these factors as well as the specific factors discussed with each forward-looking statement in this report and as disclosed in the Company's filings with the Securities and Exchange Commission. These factors, in some cases, have affected, and in the future (together with other factors) could affect, the ability of the Company to implement its business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this report.
16
BOSTON SCIENTIFIC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN MILLIONS, EXCEPT PER SHARE DATA)
YEAR ENDED DECEMBER 31, 2002 2001 2000 ----------------------- ------- ------- ------- Net sales $ 2,919 $ 2,673 $ 2,664 Cost of products sold 870 919 832 ------- ------- ------- Gross profit 2,049 1,754 1,832 Selling, general and administrative expenses 1,002 926 867 Amortization expense 72 136 91 Royalties 36 35 37 Research and development expenses 343 275 199 Purchased research and development 85 282 Restructuring charges 58 Litigation settlements, net (99) ------- ------- ------- 1,439 1,654 1,252 ------- ------- ------- Operating income 610 100 580 Other income (expense): Interest expense (43) (59) (70) Other, net (18) 3 17 Income before income taxes 549 44 527 Income taxes 176 98 154 ------- ------- ------- NET INCOME (LOSS) $ 373 $ (54) $ 373 ======= ======= ======= NET INCOME (LOSS) PER COMMON SHARE - BASIC $ 0.92 $ (0.13) $ 0.92 ======= ======= ======= NET INCOME (LOSS) PER COMMON SHARE - ASSUMING DILUTION $ 0.90 $ (0.13) $ 0.91 ======= ======= ======= |
(see notes to consolidated financial statements)
BOSTON SCIENTIFIC AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(IN MILLIONS, EXCEPT SHARE AND PER SHARE DATA)
DECEMBER 31, 2002 2001 ----------- ------ ------ ASSETS Current assets: Cash and cash equivalents $ 277 $ 180 Trade accounts receivable, net 435 370 Inventories 243 303 Deferred income taxes 168 174 Prepaid expenses and other current assets 85 79 ------ ------ Total current assets 1,208 1,106 Property, plant and equipment, net 636 592 Excess of cost over net assets acquired 1,168 928 Technology - core, net 553 541 Technology - developed, net 217 221 Patents, net 316 264 Licenses and other intangibles, net 113 110 Investments 210 154 Other assets 29 58 ------ ------ $4,450 $3,974 ====== ====== |
(see notes to consolidated financial statements)
18
BOSTON SCIENTIFIC AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(IN MILLIONS, EXCEPT SHARE AND PER SHARE DATA)
DECEMBER 31, 2002 2001 ----------- ------- ------- LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Commercial paper $ 88 $ 99 Bank obligations 132 Accounts payable 66 54 Accrued expenses 639 421 Income taxes payable 102 115 Other current liabilities 28 10 ------- ------- TOTAL CURRENT LIABILITIES 923 831 Long-term debt 847 973 Deferred income taxes 100 43 Other long-term liabilities 113 112 Commitments and contingencies Stockholders' equity: Preferred stock, $ .01 par value - authorized 50,000,000 shares, none issued and outstanding Common stock, $ .01 par value - authorized 600,000,000 shares, 414,882,413 shares issued at December 31, 2002 and 2001 4 4 Additional paid-in capital 1,250 1,225 Treasury stock, at cost - 3,490,451 shares at December 31, 2002 and 9,628,790 shares at December 31, 2001 (54) (173) Deferred compensation (10) Retained earnings 1,394 1,031 Accumulated other comprehensive income (loss): Foreign currency translation adjustment (119) (131) Unrealized (loss) gain on available-for-sale securities, net (2) 25 Unrealized (loss) gain on derivative financial instruments, net (4) 44 Minimum pension liability (2) ------- ------- TOTAL STOCKHOLDERS' EQUITY 2,467 2,015 ------- ------- $ 4,450 $ 3,974 ======= ======= |
(see notes to consolidated financial statements)
BOSTON SCIENTIFIC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(IN MILLIONS, EXCEPT SHARE DATA)
Common Stock ------------------ Accumulated Compre- Shares Additional Other hensive Issued (in Par Paid-In Treasury Deferred Retained Comprehensive Income thousands) Value Capital Stock Compensation Earnings Income (Loss) (Loss) ---------- ----- ------- ----- ------------ -------- ------------- ------- BALANCE AT DECEMBER 31, 1999 414,882 $ 4 $ 1,210 $ (126) $ $ 752 $ (116) $ 326 ----- Comprehensive income: Net income 373 $ 373 Other comprehensive income (expense), net of tax: Foreign currency translation adjustment (19) (19) Net change in equity investments 10 10 Net change in derivative financial instruments 27 27 Issuance of common stock (7) 45 (9) Issuance of restricted stock 2 24 (26) Cancellation of restricted stock (3) 3 Purchases of common stock for treasury (222) Tax benefit relating to incentive stock option and employee stock purchase plans 5 Amortization of deferred compensation 8 ------- ---- ------- ------ -------- -------- ------ ----- BALANCE AT DECEMBER 31, 2000 414,882 4 1,210 (282) (15) 1,116 (98) $ 391 ----- Comprehensive loss: Net loss (54) $ (54) Other comprehensive income, net of tax: Foreign currency translation adjustment 11 11 Net change in equity investments 8 8 Net change in derivative financial instruments 17 17 Issuance of common stock (6) 75 (27) Issuance of common stock for acquisitions 13 36 (9) (4) Cancellation of restricted stock (2) 2 Tax benefit relating to incentive stock option and employee stock purchase plans 8 Amortization of deferred compensation 12 ------- ---- ------- ------ -------- -------- ------ ----- BALANCE AT DECEMBER 31, 2001 414,882 4 1,225 (173) (10) 1,031 (62) $ (18) ----- Comprehensive income: Net income 373 $ 373 Other comprehensive income (expense), net of tax: Foreign currency translation adjustment 12 12 Net change in equity investments (27) (27) Net change in derivative financial instruments (48) (48) Net change in minimum pension liability (2) (2) Issuance of common stock (3) 120 (10) Cancellation of restricted stock (1) Tax benefit relating to incentive stock option and employee stock purchase plans 28 Amortization of deferred compensation 10 ------- ---- ------- ------ -------- -------- ------ ----- BALANCE AT DECEMBER 31, 2002 414,882 $ 4 $ 1,250 $ (54) $ 0 $ 1,394 $ (127) $ 308 ======= ==== ======= ====== ======== ======== ====== ===== |
(see notes to consolidated financial statements)
20
BOSTON SCIENTIFIC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN MILLIONS)
YEAR ENDED DECEMBER 31, 2002 2001 2000 ----- ----- ----- OPERATING ACTIVITIES: Net income (loss) $ 373 $ (54) $ 373 Adjustments to reconcile net income (loss) to cash provided by operating activities: Gain on sale of equity investments (26) (11) (14) Depreciation and amortization 161 232 181 Deferred income taxes 142 8 2 Purchased research and development 85 282 Tax benefit relating to stock option and employee stock purchase plans 28 8 5 Increase (decrease) in cash flows from operating assets and liabilities: Trade accounts receivable (51) (6) 78 Inventories 63 53 15 Prepaid expenses and other assets (38) (9) (24) Accounts payable and accrued expenses 56 28 (27) Accrual for restructuring and merger-related charges (49) (31) 45 Other liabilities (17) (22) 91 Other, net 9 12 14 ----- ----- ----- Cash provided by operating activities 736 490 739 INVESTING ACTIVITIES: Purchases of property, plant and equipment (112) (121) (76) Proceeds from sales of property, plant and equipment 2 5 4 Sales of available-for-sale securities 31 20 15 Acquisitions of businesses, net of cash acquired (187) (620) Payments for acquisitions of and/or investments in certain technologies, net (202) (84) (50) ----- ----- ----- Cash used for investing activities (468) (800) (107) FINANCING ACTIVITIES: Net (decrease) increase in commercial paper (11) 43 (221) Net (payments on) proceeds from borrowings on revolving credit facilities (237) 360 (234) Proceeds from notes payable and long-term borrowings 13 4 22 Payments on notes payable, capital leases and long-term borrowings (48) (12) (14) Proceeds from issuances of shares of common stock 107 42 29 Acquisitions of treasury stock (222) Other, net 1 2 ----- ----- ----- Cash (used for) provided by financing activities (175) 437 (638) Effect of foreign exchange rates on cash 4 (1) (4) ----- ----- ----- Net increase (decrease) in cash and cash equivalents 97 126 (10) Cash and cash equivalents at beginning of year 180 54 64 ----- ----- ----- CASH AND CASH EQUIVALENTS AT END OF YEAR $ 277 $ 180 $ 54 ===== ===== ===== |
(see notes to consolidated financial statements)
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE A - SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES OF CONSOLIDATION: The consolidated financial statements include the accounts of Boston Scientific Corporation (Boston Scientific or the Company) and its subsidiaries, substantially all of which are wholly owned. Investments in companies over which Boston Scientific has the ability to exercise significant influence are accounted for under the equity method if Boston Scientific holds 50 percent or less of the voting stock. Investments in companies over which Boston Scientific does not have the ability to exercise significant influence are accounted for under the cost method. Due to the ongoing litigation between Medinol Ltd. (Medinol) and the Company and the lack of available financial information, the Company believes that it no longer has the ability to exercise significant influence over Medinol's operating and financial policies. Therefore, during the third quarter of 2002, Boston Scientific changed to the cost method of accounting for its investment in Medinol from the equity method. This change had no material impact on the Company's financial statements. At December 31, 2002, the Company had a 22 percent ownership interest in Medinol at a carrying value of approximately $24 million.
ACCOUNTING ESTIMATES: The preparation of financial statements in conformity with accounting principles generally accepted in the United States (U.S.) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
CASH AND CASH EQUIVALENTS: The Company considers all highly liquid investments purchased with a maturity of three months or less to be cash equivalents.
CONCENTRATIONS OF CREDIT RISK: Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, marketable securities, derivative instrument contracts and accounts receivable. The Company invests its excess cash primarily in high-quality securities and limits the amount of credit exposure to any one financial institution. The Company's investment policy limits exposure to concentrations of credit risk and changes in market conditions. Counterparties to financial instruments expose the Company to credit-related losses in the event of nonperformance. The Company transacts derivative instrument contracts with a diversified group of major financial institutions to limit its credit exposure.
The Company provides credit, in the normal course of business, primarily to hospitals, private and governmental institutions and health care agencies, clinics and doctors' offices. The Company performs ongoing credit evaluations of its customers and maintains allowances for potential credit losses.
INVENTORIES: Inventories are stated at the lower of first-in, first-out cost or market. Provisions for excess inventory are primarily based on management's estimates of forecasted sales levels. Provisions for inventory located in the Company's manufacturing and distribution facilities are recorded as cost of sales. Generally, write-downs of consignment inventory are charged to selling, general and administrative expenses.
INVESTMENTS: The Company regularly reviews its investments to determine whether these investments are impaired. If so, the carrying value is written down to fair value in the period identified.
PROPERTY, PLANT AND EQUIPMENT: Property, plant, equipment and leaseholds are stated at historical cost. Expenditures for maintenance and repairs are charged to expense; additions and improvements are capitalized. The Company provides for depreciation using the straight-line method at rates that are intended to depreciate the cost of these assets over their estimated useful lives. Buildings and improvements are depreciated over a 15 to 40 year life; equipment, furniture and fixtures are depreciated over a 2 to 12 year life. Leasehold improvements are amortized on a straight-line basis over the shorter of the useful life of the improvement or the term of the lease.
The Company receives grant money equal to a percentage of expenditures on eligible capital equipment, which is recorded as deferred income and recognized ratably over the life of the underlying assets. The grant money would be repayable, in whole or in part, should the Company fail to meet certain employment goals.
22
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
INTANGIBLE ASSETS: Intangible assets are recorded at historical cost. Intangible assets acquired in a business combination, including purchased research and development, are recorded under the purchase method of accounting at their estimated fair values at the date of acquisition. The fair values of acquired intangible assets are determined by an independent appraiser using information and assumptions provided by management. Goodwill represents the excess purchase price over the fair value of the net tangible and intangible assets acquired.
The Company's intangible assets are amortized using the straight-line method over their useful lives, as applicable, as follows: patents, 3 to 20 years; licenses, 2 to 20 years; definite-lived core and developed technology, 3 to 25 years; other intangibles, various. In the first quarter of 2002, the Company ceased amortization of its excess of cost over net assets acquired (goodwill) and certain other indefinite-lived intangible assets in accordance with Financial Accounting Standards Board (FASB) Statement No. 142, Goodwill and Other Intangible Assets.
The Company reviews intangible assets at least annually to determine if any adverse conditions exist that would indicate impairment. Conditions that would trigger an impairment assessment include, but are not limited to, a significant adverse change in legal factors or business climate that could affect the value of an asset or an adverse action or assessment by a regulator. If the carrying amount of an asset exceeds the sum of its undiscounted cash flows, the carrying value is written down to fair value in the period identified. Fair value is calculated as the present value of estimated future cash flows using a risk-adjusted discount rate. Goodwill is reviewed at least annually for impairment utilizing the two-step business unit approach prescribed under Statement No. 142. Indefinite-lived intangible assets are reviewed at least annually for impairment by calculating the fair value of the assets and comparing the calculated fair values to the related carrying values.
INCOME TAXES: The Company utilizes the asset and liability method for accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
Income taxes are provided on unremitted earnings of subsidiaries outside the U.S. where such earnings are expected to be repatriated. The Company intends to determine annually the amount of unremitted earnings of non-U.S. subsidiaries to invest indefinitely in its non-U.S. operations. It is not practical to estimate the amount of taxes payable on earnings determined to be invested indefinitely in non-U.S. operations. At December 31, 2002, unremitted earnings of non-U.S. subsidiaries were $1,046 million.
TRANSLATION OF FOREIGN CURRENCY: All assets and liabilities of foreign subsidiaries are translated at the rate of exchange at year-end while sales and expenses are translated at the average rates in effect during the year. The net effect of these translation adjustments is shown in the accompanying financial statements as a component of stockholders' equity. Foreign currency transaction gains and losses are included in other, net on the consolidated statements of operations.
DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES: The Company recognizes all derivative financial instruments in the consolidated financial statements at fair value, regardless of the purpose or intent for holding the instrument, in accordance with FASB Statement No. 133, Accounting for Derivative Instruments and Hedging Activities. Changes in the fair value of derivative instruments are recorded in earnings unless hedge accounting criteria are met. For derivative instruments designated as fair value hedges, the changes in fair value of both the derivative instrument and the hedged item are recorded in earnings. For derivative instruments designated as cash flow and net investment hedges, the effective portions of changes in the fair value of the derivative are recorded in other comprehensive income (OCI). The ineffective portions are recognized in earnings.
REVENUE RECOGNITION: The Company recognizes revenue from the sale of its products when the products are shipped to its customers unless a consignment arrangement exists. Revenue from consignment customers is recognized based on product usage indicating sales are complete. The Company allows its customers to return certain products for credit. The Company also allows customers to return defective or damaged products for credit or replacement. The Company's
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
estimates for sales returns, rebates and discounts are based upon contractual commitments and historical trends and are recorded as a reduction to revenue.
SHIPPING AND HANDLING COSTS: The Company does not generally recognize revenue from shipping and handling of its products. Shipping and handling costs are recorded as selling, general and administrative expenses.
LEGAL COSTS: The Company accrues costs of settlement, damages and, under certain conditions, costs of defense when such costs are probable and estimable. Otherwise, such costs are expensed as incurred.
RESEARCH AND DEVELOPMENT: Research and development costs, including new product development programs, regulatory compliance and clinical research, are expensed as incurred.
STOCK COMPENSATION ARRANGEMENTS: The Company accounts for its stock compensation arrangements under the intrinsic value method in accordance with Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, and FASB Interpretation No. 44, Accounting for Certain Transactions Involving Stock Compensation. The Company has adopted the disclosure-only provisions of FASB Statement No. 123, Accounting for Stock-Based Compensation. Any compensation cost on fixed awards with pro rata vesting is recognized on a straight-line basis over the award's vesting period.
If the Company had elected to recognize compensation expense for the granting of
options under stock option plans based on the fair values at the grant dates
consistent with the methodology prescribed by Statement No. 123, net income
(loss) and net income (loss) per share would have been reported as the following
pro forma amounts:
YEAR ENDED DECEMBER 31, 2002 2001 2000 ------- ------- ------- (in millions, except per share data) Net income (loss), as reported $ 373 $ (54) $ 373 Add: Stock-based employee compensation expense included in net income (loss), net of related tax effects 6 8 5 Less: Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects (48) (48) (45) ------- ------- ------- PRO FORMA NET INCOME $ 331 $ (94) $ 333 ======= ======= ======= Net income (loss) per common share Basic: Reported $ 0.92 $ (0.13) $ 0.92 Pro forma $ 0.82 $ (0.23) $ 0.84 ======= ======= ======= Assuming dilution: Reported $ 0.90 $ (0.13) $ 0.91 Pro forma $ 0.80 $ (0.23) $ 0.83 ======= ======= ======= |
PENSION PLANS: The Company maintains pension plans covering certain international employees, which the Company accounts for in accordance with FASB Statement No. 87, Employers' Accounting for Pensions. The assets, liabilities and costs associated with these plans are not material.
NET INCOME (LOSS) PER COMMON SHARE: Net income (loss) per common share is based upon the weighted average number of common shares and common share equivalents outstanding each year.
NEW ACCOUNTING STANDARDS: In June 2002, the FASB issued Statement No. 146, Accounting for Costs Associated with Exit or Disposal Activities, which is effective for exit or disposal activities that are initiated after December 31, 2002. Statement No. 146 nullifies Emerging Issues Task Force Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring). Statement No. 146 requires that a liability for costs associated with an exit or disposal activity be recognized and measured at fair value when the liability is incurred rather than at the date of an entity's commitment to an exit or disposal plan. The Company adopted the provisions of Statement No. 146 effective January 1, 2003. Statement No. 146 will not impact the accounting for any restructuring plan approved and
24
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
announced as of December 31, 2002; however, the pronouncement will impact the accounting for any future exit or disposal activities.
In November 2002, the FASB issued Interpretation No. 45, Guarantor's Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others. Interpretation No.45 requires a liability to be recognized at the time a company issues a guarantee for the fair value of the obligations assumed under certain guarantee agreements. Additional disclosures about guarantee agreements are also required in the interim and annual financial statements. The disclosure provisions of Interpretation No. 45 are effective for the Company as of December 31, 2002. The provisions for initial recognition and measurement of guarantee agreements are effective on a prospective basis for guarantees that are issued or modified after December 31, 2002. The Company does not expect the recognition provisions of Interpretation No. 45 to materially impact its consolidated financial statements.
In December 2002, the FASB issued Statement No. 148, Accounting for Stock-Based Compensation - Transition and Disclosure. Statement No. 148 amends Statement No. 123 to provide alternative methods of transition to Statement No. 123's fair value method of accounting for stock-based employee compensation. Statement No. 148 also amends the disclosure provisions of Statement No. 123 and APB Opinion No. 28, Interim Financial Reporting, to require disclosure in the summary of significant accounting policies of the effects of an entity's accounting policy with respect to stock-based employee compensation on reported net income and earnings per share in annual and interim financial statements. The Company has adopted the disclosure provisions of Statement No. 148.
In January 2003, the FASB issued Interpretation No. 46, Consolidation of Variable Interest Entities, to clarify the conditions under which the assets, liabilities and activities of another entity should be consolidated into the financial statements of a company. Interpretation No. 46 requires the consolidation of a variable interest entity by a company that bears the majority of the risk of loss from the variable interest entity's activities or is entitled to receive the majority of the variable interest entity's residual returns. The provisions of Interpretation No. 46 are required to be adopted by the Company in 2003. The Company is in the process of determining the effect of adoption of Interpretation No. 46, but does not believe it will materially impact the Company's consolidated financial statements.
RECLASSIFICATIONS: Certain prior years' amounts have been reclassified to conform to the current year's presentation.
NOTE B - CASH, CASH EQUIVALENTS AND INVESTMENTS
Cash, cash equivalents and investments, stated at fair value, consisted of the following:
GROSS GROSS FAIR UNREALIZED UNREALIZED AMORTIZED (in millions) VALUE GAINS LOSSES COST ---- ---- ---- ---- DECEMBER 31, 2002 Available-For-Sale: Cash and cash equivalents $277 $277 Equity securities (with a readily determinable fair value) 14 $ 3 17 ---- ---- ---- ---- $291 $ 3 $294 ---- ---- ---- ---- DECEMBER 31, 2001 Available-For-Sale: Cash and cash equivalents $180 $180 Equity securities (with a readily determinable fair value) 52 $ 40 $ 1 13 ---- ---- ---- ---- $232 $ 40 $ 1 $193 ---- ---- ---- ---- |
The Company has no trading securities. Unrealized gains and temporary losses for available-for-sale securities are excluded from earnings and are reported, net of tax, as a separate component of stockholders' equity until realized. The cost of available-for-sale securities is based on the specific identification method.
At December 31, 2002 and 2001, the Company had investments, totaling $196 million and $107 million, respectively, in which the fair value was not readily determinable. These assets primarily represent investments in privately held corporate equity securities or investments where an observable quoted market value does not exist. The Company regularly reviews its investments to determine whether these investments are impaired. If so, the carrying value is written down to fair value in the period identified.
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The Company had restricted cash balances of approximately $36 million at December 31, 2002 related to pending litigation and tax audits. These amounts are classified as cash and cash equivalents in the consolidated balance sheets.
NOTE C - OTHER BALANCE SHEET INFORMATION
Components of selected captions in the consolidated balance sheets at December 31 consisted of:
(in millions) 2002 2001 ------ ------ TRADE ACCOUNTS RECEIVABLE Accounts receivable $ 493 $ 432 Less allowances 58 62 ------ ------ $ 435 $ 370 ====== ====== INVENTORIES Finished goods $ 145 $ 146 Work-in-process 48 69 Raw materials 50 88 ------ ------ $ 243 $ 303 ====== ====== PROPERTY, PLANT AND EQUIPMENT Land $ 60 $ 59 Buildings and improvements 412 392 Equipment, furniture and fixtures 645 594 ------ ------ 1,117 1,045 Less accumulated depreciation and amortization 481 453 ------ ------ $ 636 $ 592 ====== ====== ACCRUED EXPENSES Acquisition obligations $ 195 Payroll and related liabilities 180 $ 146 Other 264 275 ------ ------ $ 639 $ 421 ====== ====== |
During the second quarter of 2001, the Company recorded a provision of $49 million ($34 million, net of tax) for excess NIR(R) coronary stent inventory.
NOTE D - BUSINESS COMBINATIONS
During 2002, the Company paid approximately $187 million in cash to acquire Smart Therapeutics, Inc. (Smart), BEI Medical Systems Company, Inc. (BEI) and Enteric Medical Technologies, Inc. (EMT). During 2001, the Company paid approximately $620 million in cash and issued approximately 1.9 million shares valued at $40 million to acquire RadioTherapeutics Corporation (RTC), Cardiac Pathways Corporation (CPC), Interventional Technologies, Inc. (IVT), Quanam Medical Corporation (Quanam), Catheter Innovations, Inc. (CI) and Embolic Protection, Inc. (EPI). These acquisitions are intended to strengthen the Company's leadership position in interventional medicine. The Company's acquisitions were accounted for using the purchase method of accounting. The consolidated financial statements include the operating results for each acquired entity from its respective date of acquisition. Pro forma information is not presented, as the acquired companies' results of operations prior to their date of acquisition are not material, individually or in the aggregate, to the Company.
On December 3, 2002, the Company completed its acquisition of Smart. Smart develops self-expanding technologies for intracranial therapies. The acquisition is intended to strengthen the Company's leadership position in interventional stroke therapies and became part of the Company's Target division.
On June 27, 2002, the Company completed its tender offer relating to its acquisition of BEI. BEI designs, manufactures and markets less-invasive technology used by gynecologists to treat excessive uterine bleeding due to benign causes. The acquisition is intended to expand the Company's product offerings in the area of women's health and became part of the Company's Endosurgery group.
On June 13, 2002, the Company completed its acquisition of EMT. EMT designs, manufactures and markets Enteryx, ((TM)) a liquid polymer technology for the treatment of gastroe-sophageal reflux disease (GERD). The acquisition is intended to expand the Company's Endosurgery product offerings in the GERD market.
On December 11, 2001, the Company completed its acquisition of RTC. RTC develops and manufactures proprietary radiofrequency-based therapeutic devices in the field of interventional oncology for the ablation (destruction) of various forms of soft tissue lesions (tumors). The acquisition is intended to expand the Company's oncology technology portfolio.
On August 9, 2001, the Company completed its acquisition of CPC. CPC designs and markets less-invasive systems to
26
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
diagnose and treat cardiac tachyarrhythmias (abnormally rapid heart rhythms). The acquisition is intended to strengthen and broaden the Company's product offerings in the field of electrophysiology.
On April 2, 2001, the Company completed its acquisition of IVT. IVT develops, manufactures and markets less-invasive devices for use in interventional cardiology, including the Cutting Balloon(R) catheter and the Infiltrator(R) transluminal drug-delivery catheter. The acquisition is intended to strengthen the Company's market leadership position in interventional cardiology.
On March 30, 2001, the Company completed its acquisition of Quanam. Quanam develops medical devices using novel polymer technology, with a concentration on drug-delivery stent systems for use in cardiovascular applications. The acquisition is intended to broaden the Company's drug-delivery portfolio.
On March 5, 2001, the Company completed its acquisition of CI. CI develops and manufactures catheter-based venous access products used by clinicians to treat critically ill patients through the delivery of chemotherapy drugs, antibiotics and nutritional support. The acquisition is intended to expand the Company's technology portfolio in the venous access market.
On February 27, 2001, the Company completed its acquisition of EPI. EPI develops embolic protection filters for use in interventional cardiovascular procedures and also develops carotid endovascular therapies for the prevention of stroke. The acquisition is intended to accelerate the Company's entry into the embolic protection market.
Certain of the Company's 2001 and 2002 business combinations involve contingent consideration. These payments would be allocated to specific intangible asset categories or assigned to excess of cost over net assets acquired, as applicable, as if the consideration had been paid as of the date of acquisition. Payment of the additional consideration is generally contingent upon the acquired companies reaching certain performance milestones, including achieving specified revenue levels, product development targets or obtaining regulatory approvals. At December 31, 2002, the Company had an accrual for acquisition obligations of $195 million that was paid during the first quarter of 2003. In addition, the maximum potential amount of future contingent consideration (undiscounted) that the Company could be required to make associated with its 2001 and 2002 business combinations is approximately $500 million, some of which may be payable in the Company's common stock. The milestones associated with this contingent consideration must be reached in certain future periods ranging from 2003 through 2007. The specified revenue levels associated with the maximum future contingent payments is approximately $800 million.
The Company has recorded approximately $385 million of intangible assets not subject to amortization associated with its 2001 and 2002 acquisitions, which is comprised of $379 million of goodwill and $6 million of trademarks. The goodwill is not deductible for tax purposes, and has been allocated to the Company's reportable segments as follows: $368 million to the U.S., $6 million to Japan and $5 million to Europe.
The following table summarizes the purchase price assigned to the intangible assets subject to amortization acquired in connection with the 2001 and 2002 acquisitions and the weighted average amortization periods:
AMOUNT WEIGHTED AVERAGE (in millions) ASSIGNED AMORTIZATION PERIOD -------- ------------------- Technology - core $210 25 years Technology - developed 120 10 years Patents 52 14 years Other 3 13 years ---- -------- TOTAL $385 19 years ==== ======== |
The purchase price recorded for each acquisition has been allocated to the assets acquired and liabilities assumed based on their fair values at the date of acquisition. The estimated excess of purchase price over the fair value of the net tangible assets acquired was allocated to identifiable intangible assets, as valued by an independent appraiser using information and assumptions provided by management. Based upon these valuations, the Company recorded charges of approximately $85 million in 2002 and $282 million in 2001, to account for purchased research and development. The valuation of purchased research and development, for which management is primarily responsible, represents the estimated fair value at the date of acquisition related to in-process projects. As of the date of acquisition, the in-process projects had not yet
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
reached technological feasibility and had no alternative future uses. The primary basis for determining the technological feasibility of these projects is obtaining regulatory approval to market the product. Accordingly, the value attributable to these projects, which had not yet obtained regulatory approval, was expensed in conjunction with the acquisition. If the projects are not successful or completed in a timely manner, the Company may not realize the financial benefits expected for these projects.
The income approach was used to establish the fair values of purchased research and development. This approach establishes fair value by estimating the after-tax cash flows attributable to the in-process project over its useful life and then discounting these after-tax cash flows back to a present value. Revenue estimates were based on estimates of relevant market sizes, expected market growth rates, expected trends in technology and expected product introductions by competitors. In arriving at the value of the in-process research and development projects, the Company considered, among other factors, the in-process project's stage of completion, the complexity of the work completed as of the acquisition date, the costs already incurred, the projected costs to complete, the contribution of core technologies and other acquired assets, the expected introduction date and the estimated useful life of the technology. The discount rate used to arrive at a present value as of the date of acquisition was based on the time value of money and medical technology investment risk factors. For the purchased research and development programs acquired in connection with the 2002 acquisitions, risk-adjusted discount rates ranging from 17 percent to 26 percent were utilized to discount the projected cash flows. For the purchased research and development programs acquired in connection with the 2001 acquisitions, risk-adjusted discount rates ranging from 16 percent to 28 percent were utilized to discount the projected cash flows. The Company believes that the estimated purchased research and development amounts so determined represent the fair value at the date of acquisition and do not exceed the amount a third party would pay for the projects.
The most significant projects, relative to the purchased research and development charge recorded in connection with the acquisitions consummated in 2002, are EMT's Enteryx((TM)) technology for the treatment of GERD and Smart's atherosclerosis stent, which collectively represent approximately 82 percent of the 2002 in-process value. Enteryx is a patented liquid polymer for the treatment of GERD. The atherosclerosis stent is a self-expanding nitinol stent designed to treat narrowing of the arteries around the brain. As of the date of acquisition, the projects were expected to be completed and the products commercially available on a worldwide basis within one to four years, with an estimated cost to complete of approximately $2 million to $13 million.
The most significant projects, relative to the purchased research and development charge recorded in connection with the acquisitions consummated in 2001, are IVT's next-generation Cutting Balloon(R) catheter, the next-generation Infiltrator(R) transluminal drug-delivery catheter and EPI's next-generation embolic protection devices, which collectively represent approximately 63 percent of the 2001 in-process value. The Cutting Balloon is a novel balloon angioplasty device with mounted scalpels that relieve stress in the artery, reducing the force necessary to expand the vessel. This contributes to less inadvertent arterial trauma and injury as compared to standard balloon angioplasty. The Infiltrator transluminal drug-delivery catheter is designed to deliver therapeutic agents directly into the wall of the artery with high levels of efficiency. The embolic protection devices are filters that are mounted on a guidewire and are used to capture embolic material that is dislodged during cardiovascular interventions. As of the date of acquisition, the projects were expected to be completed and the products to be commercially available on a worldwide basis within one to four years, with an estimated cost to complete of approximately $30 million to $45 million.
The Company's acquired research and development projects are generally progressing in line with the estimates set forth above, with the exception of IVT's next-generation Infiltrator transluminal drug-delivery catheter project. Due to alternative drug-delivery products available to the Company, the Company has reduced its future revenue projections for this product. The Company expects to continue to pursue this and other research and development projects acquired in connection with its business combinations and believes it has a reasonable chance of completing the projects.
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BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE E - GOODWILL AND OTHER INTANGIBLE ASSETS
Effective January 1, 2002, the Company adopted the provisions of Statement No.
142. Statement No. 142 requires that goodwill and intangible assets with
indefinite useful lives no longer be amortized, but instead be tested for
impairment at least annually. As a result of adoption, the Company realized a
pre-tax benefit of approximately $46 million of amortization reductions for
goodwill and indefinite-lived intangible assets during 2002. During 2002, the
Company completed the impairment reviews required by Statement No. 142; the
Company did not recognize any impairment charges as a result of these reviews.
The following table provides comparative earnings and earnings per share had the non-amortization provisions of Statement No. 142 been adopted for all periods presented:
YEAR ENDED DECEMBER 31, 2002 2001 2000 --------- --------- ----------- (in millions, except share and per share data) Reported net income (loss) $ 373 $ (54) $ 373 Add back: amortization of goodwill, net of tax 21 18 Add back: amortization of indefinite-lived trademarks and technology - core, net of tax 10 10 --------- --------- ----------- Adjusted net income (loss) $ 373 $ (23) $ 401 ========= ========= =========== BASIC: Weighted average shares outstanding (in thousands) 407,099 401,389 405,271 Net income (loss) per common share: Reported $ 0.92 $ (0.13) $ 0.92 Adjusted $ 0.92 $ (0.06) $ 0.99 ========= ========= =========== ASSUMING DILUTION: Weighted average shares outstanding (in thousands) 414,990 401,389 408,322 Net income (loss) per common share: Reported $ 0.90 $ (0.13) $ 0.91 Adjusted $ 0.90 $ (0.06) $ 0.98 ========= ========= =========== |
The following table provides the gross carrying amount of all intangible assets and the related accumulated amortization for intangible assets subject to amortization at December 31:
2002 2001 ----------------------- ----------------------- GROSS GROSS CARRYING ACCUMULATED CARRYING ACCUMULATED (in millions) AMOUNT AMORTIZATION AMOUNT AMORTIZATION ------ ------------ ------ ------------ Amortized intangible assets: Technology - core $ 210 $ 13 $ 190 $ 5 Technology - developed 344 127 318 97 Patents 427 111 350 86 Other intangibles 174 77 162 67 ------ ------ ------ ------ TOTAL $1,155 $ 328 $1,020 $ 255 ====== ====== ====== ====== Unamortized intangible assets: Excess of cost over net assets acquired $1,168 $ 928 Technology - core 356 356 Trademarks 16 15 ------ ------ TOTAL $1,540 $1,299 ====== ====== |
Total amortization expense for the year ended December 31, 2002 was $72 million as compared to $136 million and $91 million for the years ended December 31, 2001 and 2000, respectively. During the second quarter of 2001, the Company recorded a $24 million pre-tax write-down of intangible assets.
The following table provides estimated amortization expense for each of the five succeeding fiscal years based upon the Company's intangible asset portfolio at December 31, 2002:
ESTIMATED AMORTIZATION EXPENSE FISCAL YEAR (in millions) ----------- -------------------- 2003 $ 78 2004 76 2005 76 2006 75 2007 73 |
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
The following table provides changes in the carrying amount of goodwill by segment for the year ended December 31, 2002:
UNITED INTER- (in millions) STATES EUROPE JAPAN CONTINENTAL ------------- ------ ------ ----- ----------- Balance as of December 31, 2001 $ 759 $ 95 $ 41 $ 33 Purchase price adjustments (28) (1) Goodwill acquired 85 5 Contingent consideration 177 Foreign currency translation 2 ----- ----- ---- ---- Balance as of December 31, 2002 $ 993 $ 101 $ 41 $ 33 ===== ===== ==== ==== |
The purchase price adjustments relate primarily to adjustments to properly reflect the fair value of deferred tax assets and liabilities acquired in connection with the 2001 acquisitions.
NOTE F - GLOBAL OPERATIONS STRATEGY
During the second quarter of 2002, the Company substantially completed its plant optimization initiative. The plant optimization initiative has created a better allocation of the Company's resources by forming a more effective network of manufacturing and research and development facilities. The Company's plan resulted in the consolidation of manufacturing operations along product lines and the shifting of significant amounts of production to the Company's facilities in Miami and Ireland and to contract manufacturing. The Company's plan included the discontinuation of manufacturing activities at three facilities in the U.S., and included the planned displacement of approximately 1,700 manufacturing, manufacturing support and management employees. In addition, during the second quarter of 2002, the Company recorded a $6 million pre-tax charge to cost of sales for severance and related costs associated with its global operations strategy. The approximately 250 affected employees included manufacturing, manufacturing support and management employees. The reductions result from the Company's continued achievement of operational efficiencies within its plant network and its continued effort to reduce costs. At December 31, 2002, the Company had approximately $4 million of accrued severance and related costs remaining associated with its global operations strategy. As of December 31, 2002, approximately $60 million had been charged against the restructuring accrual since the inception of the global operations strategy for the approximately 1,950 employees terminated as a part of the Company's global operations strategy.
The activity impacting the accrual for the global operations strategy is summarized in the table below:
CHARGES BALANCE CHARGES BALANCE CHARGES CHARGES BALANCE TO OPERATIONS AT DECEMBER UTILIZED AT DECEMBER TO OPERATIONS UTILIZED AT DECEMBER (in millions) IN 2000 31, 2000 IN 2001 31, 2001 IN 2002 IN 2002 31, 2002 ------------- ------- -------- ------- -------- ------- ------- -------- GLOBAL OPERATIONS STRATEGY Workforce reductions $58 $58 $(23) $35 $6 $(37) $4 |
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BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE G - BORROWINGS AND CREDIT ARRANGEMENTS
The Company's borrowings at December 31 consisted of:
(in millions) 2002 2001 ------------- ---- ---- Commercial paper $ 88 $ 99 Bank obligations - short-term 132 Long-term debt - fixed rate 517 492 Long-term debt - floating rate 320 471 Capital leases (see Note H) 10 10 |
The Company had approximately $88 million and $99 million of commercial paper outstanding at December 31, 2002 and 2001, respectively, at weighted average interest rates of 1.50 percent and 2.33 percent, respectively. In addition, the Company had approximately $113 million and $547 million in revolving credit facility borrowings outstanding at December 31, 2002 and 2001, respectively, at weighted average interest rates of 0.58 percent and 1.95 percent, respectively.
At December 31, 2002, the revolving credit facilities totaled approximately $1.6 billion, consisting of a $1 billion credit facility that terminates in May 2003 and a $600 million credit facility that terminates in August 2006. The revolving credit facilities also support the Company's commercial paper borrowings. Use of the borrowings is unrestricted and the borrowings are unsecured. The revolving credit facilities require the Company to maintain a specific ratio of consolidated total debt (as defined) to consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) (as defined) of less than or equal to 3.5 to 1. The ratio was approximately 1.1 to 1 at December 31, 2002 compared to 1.9 to 1 at December 31, 2001. In addition, the revolving credit facilities require the Company to maintain a specific ratio of consolidated EBITDA (as defined) to consolidated interest expense (as defined) of greater than or equal to 3.5 to 1. The ratio was approximately 19.6 to 1 at December 31, 2002 compared to 10.4 to 1 at December 31, 2001. The Company intends to refinance its $1 billion credit facility terminating in May 2003 with a new credit facility of up to $1 billion having similar terms and conditions.
In August 2002, the Company entered into a revolving credit and security facility providing for up to $200 million of additional borrowing capacity secured by the Company's domestic trade accounts receivable. The maximum amount available for borrowing under this facility changes based upon the amount of eligible receivables, concentration of eligible receivables and other factors. At December 31, 2002, $197 million was outstanding under this facility at an interest rate of 1.89 percent. Certain significant changes in the quality of the Company's receivables may cause an amortization event under this facility. An amortization event may require the Company to immediately repay borrowings under the facility. The financing structure required the Company to create a wholly owned entity, which is consolidated by the Company. This entity purchases U.S. trade accounts receivable from the Company and then borrows from two third-party financial institutions using these receivables as collateral. The transactions remain on the Company's balance sheet because the Company has the right to prepay any borrowings outstanding, allowing the Company to retain effective control over the receivables. Accordingly, pledged receivables and the corresponding borrowings are included as trade accounts receivable, net and long-term debt, respectively, on the accompanying consolidated balance sheets.
The Company has the ability to refinance a portion of its short-term debt on a long-term basis through its revolving credit facilities. The Company expects a minimum of $320 million of its bank obligations will remain outstanding beyond the next twelve months and, accordingly, has classified this portion as long-term borrowings at December 31, 2002, compared to $471 million of bank obligations classified as long-term at December 31, 2001.
The Company had $500 million of senior notes (the Notes) outstanding at December 31, 2002. The Notes mature in March 2005, bear a semi-annual coupon of 6.625 percent, and are not redeemable prior to maturity or subject to any sinking fund requirements. During 2001, the Company entered into a fixed to floating interest rate swap to hedge changes in the fair value of the Notes. In accordance with Statement No. 133, the Company recorded changes in the fair value of the Notes from the inception of the interest rate swap until its termination (see Note J for further discussion). In October 2002, the Company elected to terminate the swap. At the date of termination, the fair value of the swap and cash received was approximately $13 million. The Company will amortize the $13 million adjustment to the carrying amount
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
of the Notes into earnings on a straight-line basis through the maturity date of the Notes. The carrying amount of the Notes was approximately $511 million and $485 million at December 31, 2002 and 2001, respectively.
During the first quarter of 2002, the Company repaid 6 billion Japanese yen (translated to approximately $45 million at the date of repayment and $46 million at December 31, 2001) of borrowings outstanding with a syndicate of Japanese banks. In addition, the Company had approximately 800 million Japanese yen (translated to approximately $6 million) at December 31, 2002 and 1 billion Japanese yen (translated to approximately $7 million) at December 31, 2001 of borrowings outstanding from a Japanese bank used to finance a facility construction project. The interest rate on the borrowings is 2.1 percent and semi-annual principal payments are due through 2012.
The Company has uncommitted Japanese credit facilities with several commercial banks, which provided for borrowings and promissory notes discounting of up to 14.5 billion Japanese yen (translated to approximately $122 million) at December 31, 2002 and up to 15 billion Japanese yen (translated to approximately $115 million) at December 31, 2001. There were $7 million in borrowings outstanding under the Japanese credit facilities at an interest rate of 1.38 percent at December 31, 2002, compared to $8 million in borrowings at an interest rate of 1.38 percent at December 31, 2001. At December 31, 2002, approximately $102 million of notes receivable were discounted at average interest rates of approximately 1.38 percent compared to $88 million of discounted notes receivable at average interest rates of approximately 1.38 percent at December 31, 2001.
In addition, the Company had other outstanding bank obligations of $3 million and $2 million at December 31, 2002 and 2001, respectively.
Interest paid, including interest paid under capital leases and mortgage loans, amounted to $43 million in 2002, $59 million in 2001 and $69 million in 2000.
NOTE H - LEASES
Rent expense amounted to $42 million in 2002, $39 million in 2001 and $36 million in 2000. Future minimum rental commitments as of December 31, 2002 under noncancelable capital and operating lease agreements are as follows:
CAPITAL OPERATING YEAR ENDED DECEMBER 31, (in millions) LEASES LEASES ------------------------------------- ------ ------ 2003 $ 2 $ 39 2004 2 32 2005 2 19 2006 2 15 2007 2 7 Thereafter 4 50 ---- ----- TOTAL MINIMUM LEASE PAYMENTS 14 $ 162 Amount representing interest 4 ---- PRESENT VALUE OF MINIMUM LEASE PAYMENTS $ 10 |
NOTE I - FAIR VALUE OF FINANCIAL INSTRUMENTS
The following methods and assumptions were used by the Company in estimating its fair value disclosures for financial instruments. However, considerable judgment is required in interpreting market data to develop the estimates of fair value. Accordingly, the estimates presented herein are not necessarily indicative of the amounts that the Company could realize in a current market exchange.
CASH AND CASH EQUIVALENTS: The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents are valued at cost, which approximates their fair value.
INVESTMENTS: The fair values for marketable debt and equity securities are based on quoted market prices when readily determinable.
COMMERCIAL PAPER AND BANK OBLIGATIONS: The carrying amounts of the Company's borrowings under its commercial paper program and its financing agreements approximate their fair value.
32
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
LONG-TERM DEBT: The fair value of the Company's fixed rate long-term debt is estimated based on quoted market prices. The carrying amounts of the Company's floating rate long-term debt approximate their fair value.
DERIVATIVE INSTRUMENTS: The fair values of derivative instruments are estimated based on the amount that the Company would receive or pay to terminate the agreements at the reporting date. The Company had foreign exchange forward and option contracts and cross currency interest rate swap contracts outstanding in the notional amounts of $1,318 million and $864 million as of December 31, 2002 and 2001, respectively. In addition, the Company had interest rate swap contracts outstanding in the notional amounts of $63 million and $557 million as of December 31, 2002 and 2001, respectively.
The carrying amounts and fair values of the Company's financial instruments at December 31, 2002 and 2001 are as follows:
2002 2001 ---------------------------------------- CARRYING FAIR CARRYING FAIR (in millions) AMOUNT VALUE AMOUNT VALUE ------------- ----- ----- ----- ----- ASSETS: Cash, cash equivalents and investments $ 291 $ 291 $ 232 $ 232 Foreign exchange contracts 15 15 57 57 Cross currency interest rate swap contracts 19 19 LIABILITIES: Commercial paper $ 88 $ 88 $ 99 $ 99 Bank obligations - short-term 132 132 Long-term debt - fixed rate 517 544 492 496 Long-term debt - floating rate 320 320 471 471 Foreign exchange contracts 22 22 Cross currency interest rate swap contracts 5 5 Interest rate swap contracts 15 15 |
NOTE J - DERIVATIVE INSTRUMENTS AND HEDGING
ACTIVITIES
The Company operates globally, and its earnings and cash flow are exposed to market risk from changes in currency exchange rates and interest rates. The Company addresses these risks through a risk management program that includes the use of derivative financial instruments. The program is operated pursuant to documented corporate risk management policies. The Company does not enter into any derivative transaction for speculative purposes.
The Company manages its currency transaction exposures on a consolidated basis, which allows the Company to take advantage of any natural offsets. In addition, the Company uses foreign currency denominated borrowings (primarily Japanese yen) and currency forward contracts to manage its currency transaction exposures. These currency forward contracts are not designated as cash flow, fair value or net investment hedges under Statement No. 133 and therefore, are marked-to-market with changes in fair value recorded to earnings. These derivative instruments do not subject the Company's earnings or cash flows to material risk since gains and losses on these derivatives offset losses and gains on the assets and liabilities being hedged. These derivative instruments are entered into for periods consistent with the currency transaction exposures, generally one to six months.
Furthermore, the Company uses currency forward and option contracts to reduce the risk that the Company's earnings and cash flows, associated with forecasted foreign currency denominated intercompany and third-party transactions, will be adversely affected by changes in currency exchange rates. The Company, however, may be impacted by changes in currency exchange rates related to any unhedged portion. The success of the hedging program depends, in part, on forecasts of transaction activity in various currencies (currently the Japanese yen and the euro). The Company may experience unanticipated currency exchange gains or losses to the extent that there are timing differences between forecasted and actual activity during periods of currency volatility. The effective portion of any change in the fair value of the derivative instruments, designated as cash flow hedges, is recorded in other comprehensive income (OCI) until the third-party transaction associated with the hedged forecasted transaction occurs. Once the third-party transaction associated
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
with the hedged forecasted transaction occurs, the effective portion of any related gain or loss on the cash flow hedge is reclassified from OCI to earnings. In the event the hedged forecasted transaction does not occur, or it becomes probable that it will not occur, the effective portion of any gain or loss on the related cash flow hedge would be reclassified from OCI to earnings at that time. The Company did not recognize material gains or losses resulting from either hedge ineffectiveness or changes in forecast probability during 2002 or 2001. The Company recognized a net gain of approximately $39 million and $43 million in earnings from derivative instruments designated as cash flow hedges of forecasted transactions during 2002 and 2001, respectively. All of the derivative instruments, designated as cash flow hedges, outstanding at December 31, 2002, mature within the subsequent 36-month period. As of December 31, 2002, approximately $4 million of unrealized net losses are recorded in accumulated OCI (AOCI), net of tax, to recognize the effective portion of any fair value of derivative instruments that are, or previously were, designated as cash flow hedges, compared to $44 million of unrealized net gains at December 31, 2001. Of this amount, an immaterial amount, net of tax, is expected to be reclassified to earnings within the next twelve months to mitigate foreign exchange risk.
The Company uses cross currency interest rate derivative instruments to manage certain of its foreign currency denominated net investments in subsidiaries and to reduce the risk that the Company's accumulated stockholders' equity will be adversely affected by changes in currency exchange rates (primarily Japanese yen). These derivative instruments are designated as net investment hedges under Statement No. 133. The effective portion of any change in the fair value of the derivative instruments, designated as net investment hedges, is recorded in OCI. The ineffective portion of any change in the fair value is recorded in interest expense. The Company recognized $5 million of hedge ineffectiveness as a reduction in interest expense during 2002, compared to an immaterial amount in 2001. As of December 31, 2002, approximately $5 million of unrealized net losses are recorded in AOCI, as a component of foreign currency translation adjustment, to recognize the effective portion of the fair value of derivative instruments that are designated as net investment hedges, compared to $19 million of net gains at December 31, 2001. None of this amount is expected to be reclassified to earnings.
The Company uses interest rate derivative instruments to manage its exposure to interest rate movements and to reduce borrowing costs by converting floating rate debt into fixed rate debt or fixed rate debt into floating rate debt. These derivative instruments are designated as either fair value or cash flow hedges under Statement No. 133. Any change in the fair value of the derivative instruments, designated as fair value hedges, is recorded in other income and expense and is offset by changes in the fair value of the hedged debt obligation. Interest expense related to the hedged debt obligation is adjusted to reflect interest payments made or received under the interest rate derivative contracts. Any change in the fair value of the derivative instruments, designated as cash flow hedges, is recorded in OCI, net of tax, and reclassified to interest expense during the hedged interest payment period. The Company recognized $9 million of interest expense reductions related to interest rate derivative contracts during 2002, compared to an immaterial amount during 2001. The Company has recorded an immaterial amount of other long-term liabilities to recognize the fair value of these instruments at December 31, 2002, compared to $15 million of other long-term liabilities at December 31, 2001. The reduction is due to the Company's election to terminate a fixed to floating interest rate contract used to hedge changes in the fair value of its $500 million, 6.625 percent Notes due March 15, 2005. In accordance with Statement No. 133, changes in the fair value of the interest rate contracts were recorded in other income and expense and were offset by changes in the fair value of the Notes. Interest expense related to the Notes was adjusted to reflect interest payments made or received under the terms of the interest rate contracts. At the date of termination, the fair value of the interest rate contracts was approximately $13 million, and the carrying amount of the Notes was approximately $513 million. The Company received cash of $13 million upon termination of the interest rate contracts and will amortize the $13 million adjustment to the carrying amount of the Notes into earnings over the remaining term of the Notes.
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BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE K - INCOME TAXES
Income before income taxes consisted of:
YEAR ENDED DECEMBER 31, (in millions) 2002 2001 2000 ---- ---- ---- Domestic $ 305 $ (226) $ 272 Foreign 244 270 255 ----- ------ ----- $ 549 $ 44 $ 527 ===== ====== ===== |
The related provision for income taxes consisted of:
YEAR ENDED DECEMBER 31, (in millions) 2002 2001 2000 ---- ---- ---- CURRENT: Federal $ (29) $ 40 $ 115 State 2 5 8 Foreign 61 45 29 ----- ---- ----- 34 90 152 DEFERRED: Federal 144 16 (9) State 8 2 (1) Foreign (10) (10) 12 ----- ---- ----- 142 8 2 ----- ---- ----- $ 176 $ 98 $ 154 ===== ==== ===== |
The reconciliation of taxes on income at the federal statutory rate to the actual provision for income taxes is:
YEAR ENDED DECEMBER 31, (in millions) 2002 2001 2000 ---- ---- ---- Tax at statutory rate $ 192 $ 15 $ 184 State income taxes, net of federal benefit 8 3 5 Effect of foreign taxes (32) (38) (36) Purchased research and development 31 111 Refund of previously paid taxes (15) Other, net (8) 7 1 ----- ---- ----- $ 176 $ 98 $ 154 ===== ==== ===== |
Significant components of the Company's deferred tax assets and liabilities at December 31 consisted of:
(in millions) 2002 2001 ------ ----- DEFERRED TAX ASSETS: Inventory costs, intercompany profit and related reserves $ 107 $ 107 Tax benefit of net operating loss and tax credits 106 85 Reserves and accruals 76 71 Restructuring and merger-related charges, including purchased research and development 182 206 Property, plant and equipment 6 Unrealized losses on available-for-sale 1 securities Unrealized losses on derivative financial 3 instruments Other 21 16 ------ ----- 496 491 Less valuation allowance on deferred tax assets 35 37 ------ ----- $ 461 $ 454 ====== ===== DEFERRED TAX LIABILITIES: Property, plant and equipment $ (8) Intangible assets (238) $(195) Unremitted earnings of subsidiaries (90) (71) Litigation settlement (36) Unrealized gains on available-for-sale securities (14) Unrealized gains on derivative financial instruments (26) Other (21) (17) ------ ----- (393) (323) ====== ===== $ 68 $ 131 ====== ===== |
At December 31, 2002, the Company had U.S. tax net operating loss carryforwards and tax credits, the tax effect of which is approximately $90 million. In addition, the Company had foreign tax net operating loss carryforwards, the tax effect of which is approximately $16 million. These carryforwards will expire periodically beginning in the year 2003. The Company established a valuation allowance of $35 million against these carryforwards. The decrease in the valuation allowance from 2001 to 2002 is primarily attributable to the utilization of foreign tax credits.
Income taxes paid amounted to $36 million in 2002, $108 million in 2001 and $50 million in 2000. The income tax provision (benefit) of the unrealized gain or loss component of other comprehensive income (loss) was approximately $(44) million, $14 million and $21 million, for 2002, 2001 and 2000, respectively.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE L - COMMITMENTS AND CONTINGENCIES
The Company is involved in various legal proceedings, including patent infringement and product liability suits, from time to time in the normal course of business. In management's opinion, the Company is not currently involved in any legal proceeding other than those specifically identified below which, individually or in the aggregate, could have a material effect on the financial condition, operations and/or cash flows of the Company. Additionally, legal costs associated with asserting the Company's patent portfolio and defending against claims that the Company's products infringe the intellectual property of others are significant, and legal costs associated with non-patent litigation and compliance activities are rising. Depending on the prevalence, significance and complexity of these matters, the Company's legal provision could be adversely affected in the future. As of December 31, 2002, the potential exposure for litigation-related accruable costs is estimated to range from $4 million to $10 million. The Company's total accrual for litigation-related reserves as of December 31, 2002 and 2001 was approximately $4 million and $6 million, respectively. As of December 31, 2002, the range of loss for reasonably possible contingencies that can be estimated is not material.
During the third quarter of 2002, the Company entered into an agreement to settle a number of patent infringement lawsuits between the Company and Medtronic, Inc. (Medtronic). The settlement resolved the Company's damage claims against Medtronic arising out of a German court case and a U.S. arbitration proceeding involving Medtronic rapid exchange stent delivery systems and angioplasty dilatation balloon catheters. In accordance with the settlement agreement, during the third quarter of 2002, Medtronic paid the Company approximately $175 million to settle damage award claims for past infringement. In addition, during the third quarter of 2002, the Company recorded a net charge of approximately $76 million for settlement of litigation related to rapid exchange catheter technology.
LITIGATION WITH JOHNSON & JOHNSON
On October 22, 1997, Cordis Corporation (Cordis), a subsidiary of Johnson & Johnson, filed a suit for patent infringement against the Company and SCIMED Life Systems,Inc. (SCIMED), a subsidiary of the Company, alleging that the importation and use of the NIR(R) stent infringes two patents owned by Cordis. On April 13, 1998, Cordis filed a suit for patent infringement against the Company and SCIMED alleging that the Company's NIR(R) stent infringes two additional patents owned by Cordis. The suits were filed in the U.S. District Court for the District of Delaware seeking monetary damages, injunctive relief and that the patents be adjudged valid, enforceable and infringed. A trial on both actions was held in late 2000. A jury found that the NIR(R) stent does not infringe three Cordis patents, but does infringe one claim of one Cordis patent and awarded damages of approximately $324 million to Cordis. On March 28, 2002, the Court set aside the damage award, but upheld the remainder of the verdict, and held that two of the four patents had been obtained through inequitable conduct in the U.S. Patent and Trademark Office. On May 16, 2002, the Court also set aside the verdict of infringement, requiring a new trial. The case has been stayed pending the outcome of a related case.
On March 13, 1997, the Company (through its subsidiaries) filed suits against Johnson & Johnson (through its subsidiaries) in The Netherlands and Belgium, and on March 17, 1997 filed suit in France, seeking a declaration of noninfringement for the NIR(R) stent relative to two European patents licensed to Ethicon, Inc. (Ethicon), a Johnson & Johnson subsidiary, as well as a declaration of invalidity with respect to those patents. On October 28, 1998, the Company's motion for a declaration of noninfringement in France was dismissed for failure to satisfy statutory requirements; the French invalidity suits were not affected. A hearing related to the French invalidity suits was held on November 19, 2001. On January 16, 2002, the French Court found one of the patents to be valid and the other to be invalid. The Company filed an appeal on November 4, 2002.
On March 21, 1997, the Company (through its subsidiaries) filed a suit against Johnson & Johnson (through its subsidiaries) in Italy seeking a declaration of noninfringement for the NIR(R) stent relative to one of the European patents licensed to Ethicon and a declaration of invalidity. A technical expert was appointed by the Court and a hearing was held on January 30, 2002. Both parties have had an opportunity to comment on the expert report. On May 8, 2002, the Court
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BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
closed the evidentiary phase of the case and set the next hearing for December 13, 2003.
Ethicon and other Johnson & Johnson subsidiaries filed a cross-border suit in The Netherlands on March 17, 1997, alleging that the NIR(R) stent infringes one of the European patents licensed to Ethicon. In this action, the Johnson & Johnson entities requested relief, including provisional relief (a preliminary injunction), covering Austria, Belgium, France, Greece, Italy, The Netherlands, Norway, Spain, Sweden and Switzerland. On April 2, 1997, the Johnson & Johnson entities filed a similar cross-border proceeding in The Netherlands with respect to a second European patent licensed to Ethicon. In October 1997, Johnson & Johnson's request for provisional cross-border relief on both patents was denied by the Dutch Court, on the ground that it is "very likely" that the NIR(R) stent will be found not to infringe the patents. Johnson & Johnson appealed this decision with respect to the second patent; the appeal has been denied on the grounds that there is a "ready chance" that the patent will be declared null and void. In January 1999, Johnson & Johnson amended the claims of the second patent, changed the action from a cross-border case to a Dutch national action, and indicated its intent not to pursue its action on the first patent. On June 23, 1999, the Dutch Court affirmed that there were no remaining infringement claims with respect to either patent. In late 1999, Johnson & Johnson appealed this decision. A hearing on the appeal has not yet been scheduled.
On May 6, 1997, Ethicon Endosurgery, Inc., a subsidiary of Johnson & Johnson, sued the Company in Dusseldorf, Germany, alleging that the Company's NIR(R) stent infringes one of Ethicon's patents. On June 23, 1998, the case was stayed following a decision in an unrelated nullity action in which the Ethicon patent was found to be invalid.
On August 22, 1997, Johnson & Johnson filed a suit for patent infringement against the Company alleging that the sale of the NIR(R) stent infringes certain Canadian patents owned by Johnson & Johnson. Suit was filed in the federal court of Canada seeking a declaration of infringement, monetary damages and injunctive relief. The Company has answered, denying the allegations of the complaint. A trial is expected to begin in late 2003. On April 14, 2000, the Company (through its subsidiaries) and Medinol Ltd. (Medinol) filed suit for patent infringement against Johnson & Johnson, Cordis and a subsidiary of Cordis alleging that a patent owned by Medinol and exclusively licensed to the Company is infringed by Cordis' BX Velocity(TM) stent delivery system. The complaint was filed in the U.S. District Court for the District of Delaware seeking monetary and injunctive relief. On June 7, 1999, the Company, SCIMED, and Medinol filed suit for patent infringement against Johnson & Johnson, Johnson & Johnson Interventional Systems and Cordis, alleging two U.S. patents owned by Medinol and exclusively licensed to the Company are infringed by Cordis' Crown (TM), MINICrown(TM) and CORINTHIAN(TM) stents. The suit was filed in the U.S. District Court for the District of Minnesota seeking injunctive and monetary relief. The Minnesota action was transferred to the U.S. District Court for the District of Delaware and consolidated with the Delaware action filed by the Company. A trial was held in August 2001 on both actions. On September 7, 2001, a jury found that Cordis' BX Velocity, Crown, and MINICrown stents do not infringe the patents, and that the asserted claims of those patents are invalid. The jury also found that Cordis' CORINTHIAN stent infringes a valid Medinol patent claim and awarded the Company and Medinol $8.3 million in damages. On January 25, 2002, the Court entered final judgment on the CORINTHIAN stent in favor of the Company. On September 27, 2002, final judgment was entered in favor of Cordis on the BX Velocity, Crown and MINICrown stents, and the Company's motion for a new trial was denied. On November 26, 2002, Medinol filed an appeal. The Company has withdrawn from the action.
On March 24, 2000, the Company (through its subsidiaries) and Medinol filed a cross-border suit against Johnson & Johnson, Cordis and certain of their foreign subsidiaries in The Netherlands alleging Cordis' BX Velocity stent delivery system infringes one of Medinol's European patents. In this action, the Company and Medinol requested monetary and injunctive relief covering The Netherlands, Austria, Belgium, Switzerland, Germany, Denmark, Spain, France, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, Portugal and Sweden. On March 19, 2001, the Company's request for preliminary injunction was denied by the Court. On May 11, 2001, the Company appealed this decision. A hearing on the appeal is expected to be held February 20, 2003 before the Dutch Court of Appeals.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
On March 30, 2000, the Company (through its subsidiary) filed suit for patent infringement against two subsidiaries of Cordis alleging that Cordis' BX Velocity stent delivery system infringes a published utility model owned by Medinol and exclusively licensed to the Company. The complaint was filed in the District Court of Dusseldorf, Germany seeking monetary and injunctive relief. A hearing was held on March 15, 2001, and on June 6, 2001, the Court issued a written decision that Cordis' BX Velocity stent delivery system infringes the Medinol published utility model. Cordis appealed the decision of the German court. A hearing on the appeal has been scheduled for April 3, 2003.
On March 25, 1996, Cordis filed a suit for patent infringement against SCIMED alleging the infringement of five U.S. patents by SCIMED's Leap(TM) balloon material used in certain SCIMED catheter products, including SCIMED's Bandit(TM) and Express Plus(TM) catheters. The suit was filed in the U.S. District Court for the District of Minnesota and seeks monetary and injunctive relief. SCIMED has answered, denying the allegations of the complaint. Pursuant to an agreement between the parties, this action has been stayed.
On March 27, 1997, SCIMED filed suit for patent infringement against Cordis, alleging willful infringement of several SCIMED U.S. patents by Cordis' Trackstar 14(TM), Trackstar 18(TM), Olympix(TM), Powergrip(TM), Sleek(TM), Sleuth(TM), Thor(TM), Titan(TM) and Valor(TM) catheters. The suit was filed in the U.S. District Court for the District of Minnesota, seeking monetary and injunctive relief. The parties have agreed to add Cordis' Charger(TM) and Helix(TM) catheters to the suit. Cordis has answered, denying the allegations of the complaint. Pursuant to an agreement between the parties, this action has been stayed.
On February 14, 2002, the Company and certain of its subsidiaries filed suit for patent infringement against Johnson & Johnson and Cordis alleging certain balloon catheters, stent delivery systems, and guide catheters sold by Johnson & Johnson and Cordis infringe five U.S. patents owned by the Company. The complaint was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief. On October 15, 2002, Cordis filed a counter-claim alleging certain balloon catheters and stent delivery systems sold by the Company infringe three U.S. patents owned by Cordis and seeking monetary and injunctive relief.
On December 6, 2002, the Company filed an Amended Complaint alleging two additional patents owned by the Company are infringed by the Cordis products. Trial is expected to begin in mid-2004.
On March 26, 2002, the Company and Target Therapeutics, Inc. (Target), a wholly owned subsidiary of the Company, filed suit for patent infringement against Cordis alleging certain detachable coil delivery systems and/or pushable coil vascular occlusion systems (coil delivery systems) infringe three U.S. patents, owned by or exclusively licensed to Target. The complaint was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief. Trial is scheduled to begin in June 2004.
On January 13, 2003, Cordis filed suit for patent infringement against the Company and SCIMED alleging the Company's Express(2)(TM) coronary stent infringes a U.S. patent owned by Cordis. The suit was filed in the U.S. District Court for the District of Delaware seeking monetary and injunctive relief. The Company has not yet answered, but intends to vigorously deny the allegations of the complaint.
LITIGATION WITH MEDTRONIC, INC.
On March 10, 1999, the Company (through its subsidiary Schneider (Europe) AG) filed suit against Medtronic AVE, Inc. (Medtronic AVE), a subsidiary of Medtronic, Inc. (Medtronic), alleging that Medtronic AVE's AVE GFX, AVE GFX2, AVE LTX, CALYPSO RELY(TM), PRONTO SAMBA(TM) and SAMBA RELY(TM) rapid exchange catheters and stent delivery systems infringe one of the Company's German patents. The suit was filed in the District Court of Dusseldorf, Germany seeking injunctive and monetary relief. An expert's report was submitted to the Court on November 6, 2001 and a hearing was held on May 2, 2002. On June 11, 2002, the Court ruled that the Medtronic AVE products infringed the Company's patents. Medtronic AVE filed an appeal. Medtronic AVE is obligated to dismiss its appeal pursuant to a Settlement Agreement between the parties dated September 18, 2002. On November 26, 2002, the Company filed an enforcement action seeking a decision from the Court that Medtronic AVE is violating the Court's injunction through the sale of its S670 and S7 rapid exchange stent systems.
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BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
On April 6, 1999, Medtronic AVE filed suit against SCIMED and another subsidiary of the Company alleging that the Company's NIR(R) stent infringes one of Medtronic AVE's European patents. The suit was filed in the District Court of Dusseldorf, Germany seeking injunctive and monetary relief. A hearing was held in Germany on September 23, 1999, and on November 4, 1999, the Court dismissed the complaint. On December 21, 1999, Medtronic AVE appealed the dismissal. The appeal is stayed pending the outcome of a related nullity action.
On August 13, 1998, Medtronic AVE filed a suit for patent infringement against the Company and SCIMED alleging that the Company's NIR(R) stent infringes two patents owned by Medtronic AVE. The suit was filed in the U.S. District Court for the District of Delaware seeking injunctive and monetary relief. On May 25, 2000, Medtronic AVE amended the complaint to include a third patent. The Company and SCIMED have answered denying the allegations of the complaint. The parties have filed a stipulation requesting the Court to stay the case.
LITIGATION WITH GUIDANT CORPORATION
On June 7, 2002, Advanced Cardiovascular Systems, Inc. (ACS) and Guidant Ltd., subsidiaries of Guidant Corporation (Guidant), filed suit against the Company and certain of its subsidiaries alleging that the Company's Express(TM) stent infringes two patents owned by ACS. The suit was filed in the United Kingdom, but has not been served upon the Company.
On October 15, 2002, ACS filed suit for patent infringement against the Company and SCIMED alleging the Company's Express stent infringes a U.S. patent owned by ACS. The suit was filed in the U.S. District Court for the Northern District of California seeking monetary damages and injunctive relief. On December 6, 2002, the Company answered, denying the allegations of the complaint and counterclaimed seeking a declaration of invalidity, noninfringement and uneforceability.
On December 3, 2002, ACS filed suit for patent infringement against the Company and SCIMED alleging the Company's Express stent infringes a U.S. patent owned by ACS. The suit was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief. The Company has answered, denying the allegations of the complaint. On January 28, 2003, ACS filed suit for patent infringement against the Company and SCIMED alleging the Company's Express stent infringes a U.S. patent owned by ACS. The suit was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief. The Company has not yet answered, but intends to vigorously deny the allegations of the complaint.
On December 30, 2002, the Company and certain of its subsidiaries filed suit for patent infringement against Guidant, and Guidant Sales Corporation and ACS alleging that certain stent delivery systems (Multi-Link Zeta(TM) and Multi-Link Penta(TM)) and balloon catheter products (Agil-Trac(TM)) sold by Guidant and ACS infringe nine U.S. patents owned by the Company. The complaint was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief.
LITIGATION RELATING TO COOK, INC.
On September 10, 2001, the Company delivered a Notice of Dispute to Cook, Inc.
(Cook) asserting that Cook breached the terms of a certain License Agreement
among Angiotech Pharmaceuticals, Inc. (Angiotech), Cook and the Company (the
Agreement) relating to an improper arrangement between Cook and Guidant. On
December 13, 2001, Cook filed suit in the U.S. District Court for the Northern
District of Illinois seeking declaratory and injunctive relief. The Company
answered the complaint on December 26, 2001, denying the allegations and filed
counterclaims seeking declaratory and injunctive relief. On June 27, 2002, the
Court found in favor of the Company, ruling that Cook breached the Agreement. On
October 1, 2002, the Court granted the Company's request for a permanent
injunction prohibiting certain activities under the Agreement and enjoining the
use of the clinical data and technologies developed by Cook or Guidant in
violation of the Agreement. Cook appealed the decision to the U.S. Court of
Appeals for the Seventh Circuit.
On July 30, 2002, Guidant and Cook Group Incorporated, the parent of Cook, announced their agreement to merge Cook Group Incorporated into a wholly owned subsidiary of Guidant. On the same day, Guidant filed suit against the Company seeking a declaratory judgment that upon completion of the merger, the license under the Agreement may be assigned or
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
sublicensed by Cook to ACS and that ACS is entitled to use the information, data or technology generated or gathered for the purposes of obtaining regulatory approval for a coronary stent utilizing the Angiotech technology. The Company has answered the complaint and counterclaimed for declaratory and injunctive relief alleging that Guidant is tortiously interfering with Cook's performance under the Agreement.
On June 30, 1998, Cook filed suit in the Regional Court, Dusseldorf Division for Patent Disputes, in Dusseldorf, Germany against the Company alleging that the Company's Passager(TM) peripheral vascular stent graft and Vanguard(TM) endovascular aortic graft products infringe the same Cook patent. A hearing was held on July 22, 1999, and a decision was received in September 1999 finding that the Company's products infringe the Cook patent. The Company appealed the decision. A hearing is scheduled for March 27, 2003.
On March 18, 1999, Cook filed suit against the Company and SCIMED, alleging that SCIMED's Radius(TM) coronary stent infringes a certain U.S. patent owned by Cook. The suit was filed in the U.S. District Court for the Southern District of Indiana seeking monetary damages and injunctive relief. On July 14, 1999, Cook filed an amended complaint adding Meadox Medicals, Inc. (Meadox), a wholly owned subsidiary of the Company, as a party to the suit, and adding a breach of contract claim. The Company, SCIMED and Meadox have answered, denying the allegations of the complaint. A trial date has not yet been set.
On May 23, 2001, Cook filed suit against the Company alleging that the Company's VortX(R) embolization coils infringe a patent owned by Cook. The suit was filed in the U.S. District Court for the Southern District of Indiana seeking monetary damages and injunctive relief. On July 24, 2001, the Company answered, denying the allegations of the complaint, and countersued Cook, alleging that certain Cook products infringe a patent owned by the Company. On November 14, 2001, the Company amended its complaint against Cook to include two additional patents exclusively licensed to the Company. Cook answered and denied the allegations of the counterclaim. A trial date has not yet been set.
On March 7, 1996, Cook filed suit in the Regional Court, Munich Division for Patent Disputes, in Munich, Germany against MinTec, Inc. Minimally Invasive Technologies, alleging that the Cragg EndoPro(TM) System I and Stentor(TM) endovascular device infringe a certain Cook patent. Following the purchase of the assets of the Endotech/MinTec companies by the Company, the Company assumed control of the litigation. A final hearing was held on May 12, 1999, and the court held no infringement of the Cook patents. The case was dismissed in June 1999. Cook has appealed the decision. On July 27, 2000, the Court stayed the action pending the outcome of a nullity action filed by the Company against the patent.
On August 2, 1999, the Company filed suit against Cook and a subsidiary of Cook alleging that Cook's Zenith stent infringed a German utility model held by the Company. The suit was filed in the District Court for Dusseldorf, Germany. On May 5, 2000, judgment was rendered in favor of the Company and on June 20, 2000, Cook appealed the decision. The case has been suspended until a final decision is rendered in related German Federal Patent Court cancellation proceedings.
OTHER PATENT LITIGATION
On July 28, 2000, Dr. Tassilo Bonzel filed a complaint naming certain of the Company's Schneider Worldwide subsidiaries and Pfizer Inc. (Pfizer) and certain of its affiliates as defendants, alleging that Pfizer failed to pay Dr. Bonzel amounts owed under a license agreement involving Dr. Bonzel's patented Monorail(TM) technology. The suit was filed in the District Court for the State of Minnesota seeking monetary relief. On September 26, 2001, Dr. Bonzel and the Company reached a contingent settlement involving all but one claim asserted in the complaint. The contingency has been satisfied and the settlement is now final. On December 17, 2001, the remaining claim was dismissed without prejudice with leave to refile the suit in Germany. Dr. Bonzel has filed an appeal of the dismissal of the remaining claim.
On September 12, 2002, EV3 filed suit against The Regents of the University of California and a subsidiary of the Company in the District Court of The Hague, Netherlands, seeking a declaration that EV3's EDC II and VDS embolic coil products do not infringe three patents licensed by the Company from The Regents of the University of California. The Company answered, denying the allegations of the complaint. A hearing has been scheduled for May 16, 2003.
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BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
On January 21, 2003, Dendron GmbH, EV3 Ltd., EV3 International, Inc., Microvena Corporation and Microtherapeutics, Inc. (the EV3 Parties) filed suit against The Regents of the University of California in the United Kingdom seeking a declaration that certain of the EV3 Parties' detachable coil and microcatheter products do not infringe a patent licensed by the Company from The Regents of the University of California and revocation of the patent. The Company has not yet answered, but intends to vigorously deny the allegations of the complaint.
On August 27, 2001, RITA Medical Systems, Inc. (RITA) filed suit against RadioTherapeutics Corporation (RTC) alleging that RTC's LeVeen(TM) radiofrequency ablation devices infringe six patents owned by RITA. The suit was filed in the U.S. District Court for the Northern District of California seeking monetary damages and injunctive relief. RTC answered, denying the allegations of the complaint. On December 11, 2001, the Company acquired RTC and assumed defense of the litigation.
On April 11, 2002, RTC, SCIMED and The Board of Regents of the University of Nebraska UNEMED Corp. (the University) filed suit against RITA alleging that certain of its products infringe a patent owned by SCIMED and other patents owned by the University and licensed to RTC. The suit was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief.
On July 9, 2002, the Company and University of Kansas filed suit against RITA alleging that certain of its products infringe a patent owned by the University and licensed to the Company. The suit was filed in the U.S. District Court for the Northern District of California seeking monetary and injunctive relief.
On October 16, 2002, RTC filed an appeal to the U.S. District Court for the Northern District of California regarding a U.S. Patent and Trademark Office (USPTO) decision in an earlier interference proceeding involving a patent owned by RITA. The USPTO had found that neither RTC nor RITA was entitled to the contested claim.
On August 13, 2001, Joseph Grayzel filed suit against the Company in the U.S. District Court of New Jersey alleging that the Company's Cutting Balloon(R) catheter infringes a patent owned by him. The suit requests monetary and injunctive relief. The Company has answered, denying the allegations of the complaint.
On November 26, 2002, the Company filed suit against Artes Medical USA, Inc. (Artes) alleging that the Company's Contour SE embolic agent does not infringe a certain patent owned by Artes, and that the patent is not valid. The suit was filed in the U.S. District Court for the District of Massachusetts seeking monetary and injunctive relief.
LITIGATION WITH MEDINOL LTD.
On April 5, 2001, Medinol Ltd. (Medinol) filed a complaint against the Company and certain of its current and former employees alleging breaches of contract, fraud and other claims. The suit was filed in the U.S. District Court for the Southern District of New York seeking monetary and injunctive relief. On April 26, 2001, Medinol amended its complaint to add claims alleging misappropriation of trade secrets in relation to the Company's Express(TM) stent development program. Medinol seeks monetary and injunctive relief, as well as an end to the Company's right to distribute Medinol stents and to gain access to certain Company intellectual property. On April 30, 2001, the Company answered and countersued Medinol and its principals, seeking monetary and injunctive relief. During the last quarter of 2001, the Court dismissed several of the individuals from the case. A trial date has not yet been set.
On June 11, 2001, the Company filed suit in the Jerusalem District Court in Israel against Medinol and its controlling shareholders, alleging among other things, loss of faith among Medinol's shareholders, breach of duty by Medinol management and misappropriation of corporate opportunities, including trade secrets and intellectual property. The suit seeks, among other things, monetary relief and costs. Preliminary motions were heard on October 29, 2001. Medinol and its shareholders requested the Court to strike the claim on the grounds of lack of jurisdiction. The Court rejected the motion except for the nomination of a director to Medinol, which was referred to the District Court of New York. A preliminary hearing is scheduled for May 11, 2003.
On April 22, 2002, Medinol filed suit against Boston Scientific Medizintechnik GmbH, a German subsidiary of the Company, alleging the Company's Express stent infringes certain German patents and utility models owned by Medinol. The suit was
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
filed in Dusseldorf, Germany. On July 11, 2002, a default judgment was entered against the subsidiary and on July 12, 2002, the subsidiary appealed the judgment and requested that the case be heard on the merits. On August 1, 2002, the Court agreed to hear the case. Hearings have been scheduled for May 15 and 27, 2003.
On January 21, 2003, Medinol filed suit against several of the Company's international subsidiaries in the District Court of The Hague, Netherlands seeking cross-border, monetary and injunctive relief covering The Netherlands, Austria, Belgium, United Kingdom, Ireland, Switzerland, Sweden, Spain, France, Portugal and Italy, alleging the Company's Express(TM) stent infringes four European patents owned by Medinol. A hearing is scheduled for October 10, 2003.
On September 10, 2002, the Company filed suit against Medinol alleging Medinol's NIRFlex(TM) and NIRFlex(TM) Royal products infringe two patents owned by the Company. The suit was filed in Dusseldorf, Germany seeking monetary and injunctive relief. A hearing is scheduled for February 4, 2003.
On September 25, 2002, the Company filed suit against Medinol alleging Medinol's NIRFlex(TM) and NIRFlex(TM) Royal products infringe a patent owned by the Company. The suit was filed in the District Court of The Hague, Netherlands seeking cross-border, monetary and injunctive relief. A hearing has been scheduled for June 13, 2003.
OTHER PROCEEDINGS
In October 1998, the Company recalled its NIR ON(R) Ranger(TM) with Sox(TM) coronary stent delivery system following reports of balloon leaks. In November 1998, the U.S. Department of Justice began an investigation regarding the shipment and sale of the NIR ON(R) Ranger(TM) with Sox(TM) stent delivery system and other aspects of the Company's relationship with Medinol, the vendor of the stent. The Company and two senior officials have been advised that they are targets of the federal grand jury investigation, but that no final decision has been made as to whether any potential charges would be brought. The Company believes that the statute of limitations for certain charges, which could potentially arise from the investigation, may expire during the year 2003 and that this may serve as a catalyst for activity during the year. There can be no assurance that the investigation will result in an outcome favorable to the Company; that charges would not be brought; or that the Company would not agree to an extension of the statute. The Company believes that it will ultimately be demonstrated that the Company and its officials acted responsibly and appropriately.
On October 31, 2000, the Federal Trade Commission (FTC) filed suit against the Company for alleged violations of a Consent Order dated May 5, 1995, pursuant to which the Company had licensed certain intravascular ultrasound technology to Hewlett-Packard Company (HP). The suit was filed in the U.S. District Court for the District of Massachusetts seeking civil penalties and injunctive relief. The Company filed a motion to dismiss the complaint and the FTC filed a motion for summary judgment. On October 5, 2001, the Court dismissed three of the five claims against the Company and granted summary judgment of liability in favor of the FTC on the two remaining claims. A trial on a civil penalty, together with post-trial briefing, has been completed. A decision has not yet been rendered.
On January 10, 2002 and January 15, 2002, Alan Schuster and Antoinette Loeffler, respectively, putatively initiated shareholder derivative lawsuits for and on behalf of the Company in the U.S. District Court for the Southern District of New York against the Company's then current directors and the Company as nominal defendant. Both complaints allege, among other things, that with regard to the Company's relationship with Medinol, the defendants breached their fiduciary duties to the Company and its shareholders in the management and affairs of the Company, and in the use and preservation of the Company's assets. The suits seek a declaration of the directors' alleged breach, damages sustained by the Company as a result of the alleged breach, monetary and injunctive relief. On October 18, 2002, the plaintiffs filed a consolidated amended complaint naming two senior officials as defendants and the Company as nominal defendant. On November 15, 2002, defendants moved to dismiss the complaint and, alternatively, for a stay of this litigation pending resolution of a separate lawsuit brought by Medinol against the Company. Plaintiffs have consented to the stay sought by defendants.
Further, product liability claims against the Company may be asserted in the future related to events not known to
42
Boston Scientific And Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
management at the present time. As a result of current economic factors impacting the insurance industry, at the beginning of the third quarter of 2002, the Company elected to become substantially self-insured with respect to general and product liability claims. Losses for claims in excess of the limits of purchased insurance would be recorded at the time and to the extent they are probable and estimable. Management believes that the Company's risk management practices, including limited insurance coverage, are reasonably adequate to protect against anticipated general and product liability losses. However, unanticipated catastrophic losses could have a material adverse impact on the Company's financial position, results of operations and liquidity.
NOTE M - STOCKHOLDERS' EQUITY
PREFERRED STOCK: The Company is authorized to issue 50 million shares of preferred stock in one or more series and to fix the powers, designations, preferences and relative participating, option or other rights thereof, including dividend rights, conversion rights, voting rights, redemption terms, liquidation preferences and the number of shares constituting any series, without any further vote or action by the Company's stockholders. At December 31, 2002, the Company had no shares of preferred stock outstanding.
COMMON STOCK: The Company is authorized to issue 600 million shares of common stock, $.01 par value per share. Holders of common stock are entitled to one vote per share. Holders of common stock are entitled to receive dividends when and if declared by the Board of Directors and to share ratably in the assets of the Company legally available for distribution to its stockholders in the event of liquidation. Holders of common stock have no preemptive, subscription, redemption or conversion rights. The holders of common stock do not have cumulative voting rights. The holders of a majority of the shares of common stock can elect all of the directors and can control the management and affairs of the Company.
The Company is authorized to purchase on the open market and in private transactions up to approximately 60 million shares of the Company's common stock. Stock repurchased would principally be used to satisfy the Company's obligations pursuant to its equity incentive plans, but may also be used for general corporate purposes, including acquisitions. During 2002 and 2001, the Company did not repurchase any shares as compared to approximately 12 million shares at an aggregate cost of $222 million repurchased by the Company in 2000. As of December 31, 2002, a total of approximately 38 million shares of the Company's common stock have been repurchased, including 26 million shares repurchased in years prior to 2000.
NOTE N - STOCK OWNERSHIP PLANS
EMPLOYEE AND DIRECTOR STOCK INCENTIVE PLANS
Boston Scientific's 1992, 1995 and 2000 Long-Term Incentive Plans provide for the issuance of up to 60 million shares of common stock. The terms of these three plans are similar. Together, the plans cover officers of, directors of, employees of and consultants to the Company and provide for the grant of various incentives, including qualified and non-qualified options, stock grants, share appreciation rights and performance awards. Options granted to purchase shares of common stock are either immediately exercisable or exercisable in installments as determined by the Compensation Committee of the Board of Directors, which consists of two or more non-employee directors (the Committee), and expire within ten years from date of grant. In the case of qualified options, if an employee owns more than 10 percent of the voting power of all classes of stock, the option granted will be at 110 percent of the fair market value of the Company's common stock on the date of grant and will expire over a period not to exceed five years. The 1992 Long-Term Incentive Plan expired on March 31, 2002, after which time grants were issued under the 1995 and 2000 Long-Term Incentive Plans.
The Committee may also make stock grants in which shares of common stock may be issued to directors, officers, employees and consultants at a purchase price less than fair market value. The terms and conditions of such issuances, including whether achievement of individual or Company performance targets is required for the retention of such awards, are determined by the Committee. The Committee may also issue shares of common stock and/or authorize cash awards under the incentive plans in recognition of the achievement of long-term performance objectives established by the Committee.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
In January 2000, the Company granted under its 1992 and 1995 Long-Term Incentive Plans approximately 1.1 million shares of its common stock to a limited group of employees subject to certain forfeiture restrictions. The purpose of the program was to help retain key employees. The market value of these shares was approximately $26 million on the date of issuance and the shares vested over three years. This amount was recorded as deferred compensation, which is shown as a separate component of stockholders' equity. The deferred compensation was amortized to expense over the vesting period and amounted to approximately $6 million, $7 million and $8 million for the years ended December 31, 2002, 2001 and 2000, respectively. The Company reversed approximately $5 million of deferred compensation associated with forfeitures of these restricted shares.
There were no stock grants issued to employees during 2002; stock grants for 50,000 shares were issued to employees during 2001. During the years ended December 31, 2002, 2001 and 2000, approximately 24,000 shares, 91,000 shares and 143,000 shares, respectively, of restricted stock were forfeited.
Boston Scientific's 1992 Non-Employee Directors' Stock Option Plan provides for the issuance of up to 200,000 shares of common stock and authorizes the automatic grant to outside directors of options to acquire a specified number of shares of common stock generally on the date of each annual meeting of the stockholders of the Company or on the date a non-employee director is first elected to the Board of Directors. Options under this plan are exercisable ratably over a three-year period and expire ten years from the date of grant. This plan expired on March 31, 2002 after which time grants to outside directors were issued under the 2000 Long-Term Incentive Plan.
A table illustrating the effect on net income (loss) and net income (loss) per
share as if the fair value method had been applied is presented in Note A. The
fair value of the stock options used to calculate the pro forma net income
(loss) and net income (loss) per share were estimated using the Black-Scholes
options pricing model with the following weighted average assumptions:
2002 2001 2000 Dividend yield 0% 0% 0% Expected volatility 49.80% 51.40% 47.20% Risk-free interest rate 3.18% 4.86% 6.01% Actual forfeitures 1,363,936 3,316,000 2,737,000 Expected life 5.0 6.0 4.6 |
The weighted average grant-date fair value per share of options granted during 2002, 2001 and 2000, calculated using the Black-Scholes options pricing model, is $19.15, $12.70 and $8.67, respectively.
Information related to stock options at December 31 under stock incentive plans is as follows:
(option amounts in thousands) 2002 2001 2000 ----------------------------- ---- ---- ---- WEIGHTED WEIGHTED WEIGHTED AVERAGE AVERAGE AVERAGE EXERCISE EXERCISE EXERCISE OPTIONS PRICE OPTIONS PRICE OPTIONS PRICE ------- ----- ------- ----- ------- ----- Outstanding at January 1 43,977 $ 21.56 44,573 $ 21.36 31,511 $ 23.63 Granted 5,334 41.10 6,007 21.66 18,441 18.22 Exercised (5,376) 17.05 (2,482) 12.13 (1,348) 11.23 Canceled (1,826) 25.35 (4,121) 25.16 (4,031) 28.18 ------ ------- ------ ------- ------ ------- OUTSTANDING AT DECEMBER 31 42,109 24.45 43,977 21.56 44,573 21.36 ====== ======= ====== ======= ====== ======= EXERCISABLE AT DECEMBER 31 24,439 $ 22.09 21,709 $ 21.03 16,921 $ 19.56 ====== ======= ====== ======= ====== ======= |
44
BOSTON SCIENTIFIC AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
Below is additional information related to stock options outstanding and
exercisable at December 31, 2002:
(option amounts in thousands) STOCK OPTIONS OUTSTANDING STOCK OPTIONS EXERCISABLE ----------------------------- ------------------------- ------------------------- WEIGHTED WEIGHTED WEIGHTED AVERAGE AVERAGE AVERAGE REMAINING EXERCISE EXERCISE RANGE OF EXERCISE PRICES OPTIONS CONTRACTUAL LIFE PRICE OPTIONS PRICE ------------------------ ------- ---------------- ----- ------- ----- $ 0.00 - 8.00 2,191 1.55 $ 4.97 2,076 $ 5.16 8.01 - 16.00 8,777 6.67 12.89 5,901 12.88 16.01 - 24.00 6,951 6.54 18.64 4,210 19.22 24.01 - 32.00 12,846 6.83 26.02 6,998 25.86 32.01 - 40.00 6,382 5.88 36.07 5,113 36.19 40.01 - 48.00 4,962 9.81 42.60 141 44.73 ------ ---- ------ ------ ------ 42,109 6.68 $24.45 24,439 $22.09 ====== ==== ====== ====== ====== |
Shares reserved for future issuance under all of the Company's incentive plans totaled approximately 44 million at December 31, 2002.
STOCK PURCHASE PLAN
Boston Scientific's Global Employee Stock Ownership Plan (Stock Purchase Plan) provides for the granting of options to purchase up to 7.5 million shares of the Company's common stock to all eligible employees. Under the Stock Purchase Plan, each eligible employee is granted, at the beginning of each period designated by the Committee as an offering period, an option to purchase shares of the Company's common stock equal to not more than 10 percent of the employee's eligible compensation. Such options may be exercised generally only to the extent of accumulated payroll deductions at the end of the offering period, at a purchase price equal to 85 percent of the fair market value of the Company's common stock at the beginning or end of each offering period, whichever is less.
During 2002, approximately 919,000 shares were issued at prices ranging from $14.93 to $19.34 per share. During 2001, approximately 1,106,000 shares were issued at prices ranging from $11.48 to $11.64 per share, and during 2000, approximately 754,000 shares were issued at prices ranging from $18.59 to $18.65 per share. At December 31, 2002, there were approximately 2.7 million shares available for future issuance.
Boston Scientific And Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE O - EARNINGS PER SHARE
The following table sets forth the computations of basic and diluted earnings
per share:
YEAR ENDED DECEMBER 31, 2002 2001 2000 (in millions, except share and per share data) BASIC: Net income (loss) $ 373 $ (54) $ 373 ======== ========= ========= Weighted average shares outstanding (in thousands) 407,099 401,389 405,271 ======== ========= ========= Net income (loss) per common share $ 0.92 $ (0.13) $ 0.92 ======== ========= ========= ASSUMING DILUTION: Net income (loss) $ 373 $ (54) $ 373 ======== ========= ========= Weighted average shares outstanding (in thousands) 407,099 401,389 405,271 Net effect of dilutive stock-based compensation (in thousands) 7,891 3,051 -------- --------- --------- TOTAL 414,990 401,389 408,322 ======== ========= ========= NET INCOME (LOSS) PER COMMON SHARE $ 0.90 $ (0.13) $ 0.91 ======== ========= ========= |
During 2002, 2001 and 2000, approximately 10 million, 24 million and 24 million potential common shares, respectively, were not included in the computation of earnings per share, assuming dilution, because exercise prices were greater than the average market price of the common shares. The net effect of dilutive stock-based compensation was approximately 5 million common share equivalents in 2001; however, this amount was not included in the computation of earnings per share, assuming dilution, because it would have been antidilutive.
NOTE P - SEGMENT REPORTING
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices for less-invasive procedures. The Company has four reportable operating segments based on geographic regions: the United States, Europe, Japan and Inter-Continental. Each of the Company's reportable segments generates revenues from the sale of less-invasive medical devices. The reportable segments represent an aggregate of operating divisions.
Sales and operating results of reportable segments are based on internally derived standard foreign exchange rates, which may differ from year to year and do not include inter-segment profits. The segment information for 2001 and 2000 sales and operating results has been restated based on the Company's standard foreign exchange rates used for 2002. Because of the interdependence of the reportable segments, the operating profit as presented may not be representative of the geographic distribution that would occur if the segments were not interdependent. Total assets and purchases of property, plant and equipment are based on foreign exchange rates used in the Company's consolidated financial statements.
UNITED INTER- (in millions) STATES EUROPE JAPAN CONTINENTAL TOTAL 2002: Net sales $1,756 $424 $494 $229 $2,903 Depreciation and amortization 26 4 3 2 35 Operating income excluding special charges 632 149 285 67 1,133 Total assets 1,605 531 222 103 2,461 Purchases of property, plant and equipment 72 2 3 2 79 2001: Net sales $1,598 $369 $508 $181 $2,656 Depreciation and amortization 25 4 4 3 36 Operating income excluding special charges 570 107 304 17 998 Total assets 1,338 472 194 104 2,108 Purchases of property, plant and equipment 65 2 5 3 75 2000: Net sales $1,577 $353 $481 $150 $2,561 Depreciation and amortization 29 3 3 2 37 Operating income excluding special charges 592 96 294 5 987 Total assets 1,251 391 201 101 1,944 Purchases of property, plant and equipment 42 2 5 4 53 |
46
Boston Scientific And Subsidiaries
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
A reconciliation of the totals reported for the reportable segments to the applicable line items in the consolidated financial statements is as follows:
YEAR ENDED DECEMBER 31, (in millions) 2002 2001 2000 NET SALES: Total net sales for reportable segments $ 2,903 $ 2,656 $ 2,561 Foreign exchange 16 17 103 ------- ------- ------- $ 2,919 $ 2,673 $ 2,664 ======= ======= ======= DEPRECIATION AND AMORTIZATION: Total depreciation and amortization allocated to reportable segments $ 35 $ 36 $ 37 Corporate expenses and foreign exchange 126 196 144 ------- ------- ------- $ 161 $ 232 $ 181 ======= ======= ======= PURCHASES OF PROPERTY, PLANT AND EQUIPMENT: Allocated to reportable segments $ 79 $ 75 $ 53 Corporate capital expenditures 33 46 23 ------- ------- ------- $ 112 $ 121 $ 76 ======= ======= ======= INCOME (LOSS) BEFORE INCOME TAXES: Total operating income excluding special charges for reportable segments $ 1,133 $ 998 $ 987 Manufacturing operations (170) (99) (98) Corporate expenses and foreign exchange (367) (517) (251) Purchased research and development (85) (282) Restructuring charges (58) Litigation settlements, net 99 ------- ------- ------- 610 100 580 Other income (expense) (61) (56) (53) ------- ------- ------- $ 549 $ 44 $ 527 ======= ======= ======= TOTAL ASSETS: Total assets for reportable segments $ 2,461 $ 2,108 $ 1,944 Corporate assets 1,989 1,866 1,483 ------- ------- ------- $ 4,450 $ 3,974 $ 3,427 ======= ======= ======= |
Enterprise-wide Information
(in millions) 2002 2001 2000 ---- ---- ---- NET SALES: Cardiovascular $ 1,979 $ 1,841 $ 1,893 Endosurgery 940 832 771 ------- ------- ------- $ 2,919 $ 2,673 $ 2,664 ======= ======= ======= LONG-LIVED ASSETS: United States $ 464 $ 439 $ 422 Ireland 134 111 103 Other foreign countries 38 42 42 ------- ------- ------- $ 636 $ 592 $ 567 ======= ======= ======= |
REPORT OF INDEPENDENT AUDITORS
BOARD OF DIRECTORS
BOSTON SCIENTIFIC CORPORATION
We have audited the accompanying consolidated balance sheets of Boston Scientific Corporation and subsidiaries as of December 31, 2002 and 2001, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 2002. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Boston Scientific Corporation and subsidiaries at December 31, 2002 and 2001, and the consolidated results of their operations and their cash flows for each of the three years in the period ended December 31, 2002 in conformity with accounting principles generally accepted in the United States.
As discussed in Note A to the consolidated financial statements, effective January 1, 2002, the Company adopted Statement of Financial Accounting Standards No. 142, Accounting for Goodwill and Other Intangible Assets.
/S/ ERNEST & YOUNG LLP Boston, Massachusetts January 29, 2003 |
Boston Scientific And Subsidiaries
FIVE-YEAR SELECTED FINANCIAL DATA
(UNAUDITED) (IN MILLIONS, EXCEPT SHARE AND PER SHARE DATA)
YEAR ENDED DECEMBER 31, 2002 2001 2000 1999 1998 OPERATING DATA: Net sales $ 2,919 $ 2,673 $ 2,664 $ 2,842 $ 2,234 Gross profit 2,049 1,754 1,832 1,856 1,499 Selling, general and administrative expenses 1,002 926 867 842 755 Amortization expense 72 136 91 92 53 Royalties 36 35 37 46 31 Research and development expenses 343 275 199 197 200 Purchased research and development 85 282 682 Restructuring and merger-related charges (credits) 58 (10) (15) Litigation settlements, net (99) Total operating expenses 1,439 1,654 1,252 1,167 1,706 Operating income (loss) 610 100 580 689 (207) Net income (loss) 373 (54) 373 371 (264) Net income (loss) per common share: Basic $ 0.92 $ (0.13) $ 0.92 $ 0.92 $ (0.68) Assuming dilution $ 0.90 $ (0.13) $ 0.91 $ 0.90 $ (0.68) Weighted average shares outstanding - assuming dilution (in thousands) 414,990 401,389 408,322 411,351 390,836 |
DECEMBER 31, 2002 2001 2000 1999 1998 BALANCE SHEET DATA: Working capital $ 285 $ 275 $ 173 $ (353) Total assets 4,450 3,974 3,427 $ 3,572 3,893 Commercial paper 88 99 56 277 1,016 Bank obligations - short-term 132 204 323 11 Long-term debt, net of current portion 847 973 574 688 1,377 Stockholders' equity 2,467 2,015 1,935 1,724 821 Book value per common share $ 6.00 $ 4.97 $ 4.84 $ 4.21 $ 2.08 |
(see notes to consolidated financial statements)
Boston Scientific And Subsidiaries
QUARTERLY RESULTS OF OPERATIONS
(UNAUDITED) (IN MILLIONS, EXCEPT PER SHARE DATA)
THREE MONTHS ENDED MARCH 31, JUNE 30, SEPTEMBER 30, DECEMBER 31, 2002 Net sales $ 675 $ 708 $ 722 $ 814 Gross profit 468 483 511 587 Operating income 125 82 246 157 Net income 82 25 161 105 Net income per common share - basic $ 0.20 $ 0.06 $0.40 $0.26 Net income per common share - assuming dilution $ 0.20 $ 0.06 $0.39 $0.25 2001 Net sales $ 654 $ 672 $ 670 $ 677 Gross profit 432 404 456 462 Operating income (loss) 40 (150) 102 108 Net income (loss) (5) (172) 58 65 Net income (loss) per common share - basic $(0.01) $(0.43) $0.14 $0.16 Net income (loss) per common share - assuming dilution $(0.01) $(0.43) $0.14 $0.16 |
During the first, second, third and fourth quarters of 2002, the Company
recorded after-tax charges (credits) of $7 million, $70 million, $(62) million
and $25 million, respectively. The net charges (credits) for the year include:
purchased research and development primarily associated with the acquisitions of
EMT and Smart; costs associated with the Company's recently completed global
operations plan; an endowment to fund a newly created philanthropic foundation;
special credits for net amounts received in connection with previously announced
settlements of litigation related to rapid exchange catheter technology; and a
reduction in income tax expense as a result of a tax refund of previously paid
taxes.
During the first, second, third and fourth quarters of 2001, the Company recorded after-tax charges of $88 million, $252 million, $20 million and $17 million, respectively. The net charges for the year include: purchased research and development related to acquisitions consummated in 2001; costs associated with the Company's global operations plan; a provision for excess inventory due to declining demand for the NIR(R) coronary stent technology; and a write-down of intangible assets related to discontinued technology platforms.
(see notes to consolidated financial statements)
50
BOSTON SCIENTIFIC AND SUBSIDIARIES
MARKET FOR THE COMPANY'S COMMON STOCK AND RELATED MATTERS
(UNAUDITED)
The following table shows the market range for the Company's common stock based on reported sales prices on the New York Stock Exchange.
2002 HIGH LOW ---- ---- --- First Quarter $25.09 $21.11 Second Quarter 31.67 24.23 Third Quarter 31.56 23.30 Fourth Quarter 44.21 32.28 |
2001 HIGH LOW ---- ---- --- First Quarter $20.79 $13.25 Second Quarter 20.50 14.50 Third Quarter 21.00 16.99 Fourth Quarter 27.89 20.30 |
The Company has not paid a cash dividend during the past five years. The Company currently intends to retain all of its earnings to finance the continued growth of its business. Boston Scientific may consider declaring and paying a dividend in the future; however, there can be no assurance that it will do so.
At December 31, 2002, there were 10,049 recordholders of the Company's common stock.
(see notes to consolidated financial statements)
.
.
.
EXHIBIT 21.1
Boston Scientific Corporation and Subsidiaries Dated March 21, 2003
NAME OF COMPANY JURISDICTION OR INCORPORATION --------------- ----------------------------- AMS Medinvent S.A. Switzerland BEI Medical Systems, Inc.. Delaware BSC Capital, Inc. Minnesota BSC Capital S.a r.l. Luxembourg BSC Finance Corp. Indiana BSC Finance Trust Massachusetts BSC International Corporation Delaware BSC International Holding Limited Ireland BSC International Medical Trading (Shanghai) Co., Ltd. People's Republic of China BSC Medical (Shanghai) Consulting Co., Ltd. People's Republic of China BSC Securities Corporation Massachusetts BSM Tip Gerecleri Limited Sirketi Turkey Boston Scientific (2001) Ltd. Israel Boston Scientific (Malaysia) Sdn. Bhd. Malaysia Boston Scientific (South Africa) (Proprietary) Limited South Africa Boston Scientific (Thailand) Ltd. Thailand Boston Scientific (Zurich) GmbH Switzerland Boston Scientific AG Switzerland Boston Scientific Argentina S.A. Argentina Boston Scientific Asia Pacific Pte. Ltd. Singapore Boston Scientific B.V. The Netherlands Boston Scientific Benelux B.V. The Netherlands Boston Scientific Benelux SA Belgium Boston Scientific Ceska Repulika, s.r.o. Czech Republic Boston Scientific Colombia Limitada Colombia Boston Scientific Cork Limited Ireland Boston Scientific Corporation Northwest Technology Washington Center, Inc. Boston Scientific Distribution Company Ireland Boston Scientific Distribution Ireland Limited Ireland Boston Scientific Eastern Europe B.V. The Netherlands Boston Scientific Europe S.P.R.L. Belgium Boston Scientific Far East B.V. The Netherlands Boston Scientific Foundation, Inc. Massachusetts Boston Scientific Funding Corporation Delaware Boston Scientific Ges.m.b.H. Austria Boston Scientific Hellas S.A. - Minimally Invasive Greece Medical Instruments Boston Scientific Holland B.V. The Netherlands Boston Scientific Hong Kong Limited Hong Kong Boston Scientific Hungary Trading Limited Liability Hungary Company Boston Scientific Iberica, S.A. Spain Boston Scientific International B.V. The Netherlands Boston Scientific International Distribution Limited Ireland Boston Scientific International Finance Limited Ireland Boston Scientific International Holding B.V. The Netherlands Boston Scientific International S.A. France Boston Scientific Ireland Limited Ireland Boston Scientific Israel Limited Israel Boston Scientific Japan K.K. Japan Boston Scientific Korea Co., Ltd. Korea Boston Scientific Latin America B.V. The Netherlands Boston Scientific Latin America B.V. (Chile) Limitada Chile Boston Scientific Limited England |
Boston Scientific Limited Ireland Boston Scientific Ltd. Canada Boston Scientific Medizintechnik GmbH Germany Boston Scientific New Zealand Limited New Zealand Boston Scientific Nordic AB Sweden Boston Scientific Puerto Rico, Inc. Puerto Rico Boston Scientific Philippines, Inc. Philippines Boston Scientific Polska Sp. z.o.o. Poland Boston Scientific Pty. Ltd. Australia Boston Scientific S.A. France Boston Scientific S.p.A. Italy Boston Scientific S.a r.l. Luxembourg Boston Scientific Scimed, Inc. Minnesota Boston Scientific Switzerland S.a.r.l. en liquidation Switzerland Boston Scientific TIP Gerecleri Limited Sirketi Turkey Boston Scientific Tullamore Limited Ireland Boston Scientific Uruguay S.A. Uruguay Boston Scientific de Mexico, S.A. de C.V. Mexico Boston Scientific de Venezuela, C.A. Venezuela Boston Scientific do Brasil Ltda. Brazil Cardiac Pathways GmbH Germany Cardiac Pathways Corporation Delaware Cardiologic Gesellschaft fur Medizintechnologien mbH Germany Catheter Innovations, Inc. Delaware CathNet-Science A/S Denmark CathNet Science Holding A/S Denmark Cathnet Science France France Corvita Canada, Inc. Canada Corvita Corporation Florida Corvita Europe S.A. Belgium Embolic Protection Incorporated Delaware Enteric Medical Technologies, Inc. Delaware EP Technologies, Inc. Delaware Forwich Limited Ireland InFlow Dynamics, Inc. Delaware InFlow Dynamics AG Germany InterVentional Technologies Europe Limited Ireland Interventional Technologies, Inc. California Interventional Therapeutics Corporation California Interventional Therapeutics Int'l California Meadox Medicals, Inc. New Jersey Nilo Holding SA Switzerland Norse Ventures B.V. The Netherlands PVS Acquisition Corp. Delaware Quanam Medical Corporation California RadioTherapeutics Corporation California SCHNEIDER/NAMIC Delaware Schneider (Europe) GmbH Switzerland Schneider Belgium N.V. Belgium Schneider Puerto Rico Delaware Scimed Life Systems, Inc. Minnesota Smart Therapeutics Inc. Delaware Symbiosis Corporation Florida Target Therapeutics, Inc. Delaware |
EXHIBIT 23.1
Consent of Independent Auditors
We consent to the incorporation by reference in this Annual Report (Form 10-K) of Boston Scientific Corporation of our report dated January 29, 2003, included in the 2002 Annual Report to Shareholders of Boston Scientific Corporation.
Our audits also included the financial statement schedule of Boston Scientific Corporation listed in Item 15(a)(2). This schedule is the responsibility of the Company's management. Our responsibility is to express an opinion based on our audits. In our opinion, the financial statement schedule referred to above, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein.
We also consent to the incorporation by reference in the Registration Statements (Forms S-8 Nos. 333-98755, 333-76380, 333-61060, 333-61056, 33-57242, 33-89772, 33-93790, 33-99766, 33-80265, 333-02256, 333-25033, 333-25037, and 333-36636 and Forms S-3 Nos. 333-76346, 333-61994, 333-37255, 333-64887, and 333-64991) of Boston Scientific Corporation and in the related Prospectus of our report dated January 29, 2003, with respect to the consolidated financial statements incorporated herein by reference, and our report included in the preceding paragraph with respect to the financial statement schedule included in this Annual Report (Form 10-K) for the year ended December 31, 2002 of Boston Scientific Corporation.
/s/ ERNST & YOUNG LLP Boston, Massachusetts March 25, 2003 |
Exhibit 99.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C.
SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report on Form 10-K of Boston Scientific
Corporation (the "Company") for the period ending December 31, 2002 as filed
with the Securities and Exchange Commission on the date hereof (the "Report"),
the undersigned Chief Executive Officer hereby certifies, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002 that based on his knowledge:
(1) the Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Boston Scientific Corporation.
By: /s/ James R. Tobin ------------------ James R. Tobin President and Chief Executive Officer Dated: March 31, 2003 |
Exhibit 99.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C.
SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report on Form 10-K of Boston Scientific
Corporation (the "Company") for the period ending December 31, 2002 as filed
with the Securities and Exchange Commission on the date hereof (the "Report"),
the undersigned Chief Financial Officer hereby certifies, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002 that based on his knowledge:
(1) the Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Boston Scientific Corporation.
By: /s/ Lawrence C. Best ------------------------------------------------- Lawrence C. Best Senior Vice President and Chief Financial Officer Dated: March 31, 2003 |