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Financial condition report In accounting, a financial condition report (FCR) is a report on the solvency condition of an insurance company that takes into account both the current financial status, as reflected in the balance sheet, and an assessment of the ability of the company to survive future risk scenarios. Risk assessment in an FCR involves dynamic solvency testing, a type of dynamic financial analysis that simulates management response to risk scenarios, to test whether a company could remain solvent in the face of deteriorating economic conditions or major disasters.
Financial statement Financial statements (or financial reports) are formal records of the financial activities and position of a business, person, or other entity.\nRelevant financial information is presented in a structured manner and in a form which is easy to understand.
Financial ratio A financial ratio or accounting ratio is a relative magnitude of two selected numerical values taken from an enterprise's financial statements. Often used in accounting, there are many standard ratios used to try to evaluate the overall financial condition of a corporation or other organization.
Financial law Financial law is the law and regulation of the insurance, derivatives, commercial banking, capital markets and investment management sectors. Understanding Financial law is crucial to appreciating the creation and formation of banking and financial regulation, as well as the legal framework for finance generally.
Trustmark (bank) Trustmark is a commercial bank and financial services company headquartered in Jackson, Mississippi, United States, with subsidiaries Trustmark National Bank, Trustmark Investment Advisors, and Fisher Brown Bottrell Insurance. The bank's initial predecessor, The Jackson Bank, was chartered by the State of Mississippi in 1889.
Financial analysis Financial analysis (also referred to as financial statement analysis or accounting analysis or Analysis of finance) refers to an assessment of the viability, stability, and profitability of a business, sub-business or project. \nIt is performed by professionals who prepare reports using ratios and other techniques, that make use of information taken from financial statements and other reports.
Form 10-K A Form 10-K is an annual report required by the U.S. Securities and Exchange Commission (SEC), that gives a comprehensive summary of a company's financial performance. Although similarly named, the annual report on Form 10-K is distinct from the often glossy "annual report to shareholders," which a company must send to its shareholders when it holds an annual meeting to elect directors (though some companies combine the annual report and the 10-K into one document).
Federal takeover of Fannie Mae and Freddie Mac In September 2008 the Federal Housing Finance Agency (FHFA) announced that it would take over the Federal National Mortgage Association (Fannie Mae) and the Federal Home Loan Mortgage Corporation (Freddie Mac). Both government-sponsored enterprises, which finance home mortgages in the United States by issuing bonds, had become illiquid as the market for those bonds collapsed in the subprime mortgage crisis.
Arithmetic Arithmetic (from Ancient Greek ἀριθμός (arithmós) 'number', and τική [τέχνη] (tikḗ [tékhnē]) 'art, craft') is an elementary part of mathematics that consists of the study of the properties of the traditional operations on numbers—addition, subtraction, multiplication, division, exponentiation, and extraction of roots. In the 19th century, Italian mathematician Giuseppe Peano formalized arithmetic with his Peano axioms, which are highly important to the field of mathematical logic today.
Operation Mincemeat Operation Mincemeat was a successful British deception operation of the Second World War to disguise the 1943 Allied invasion of Sicily. Two members of British intelligence obtained the body of Glyndwr Michael, a tramp who died from eating rat poison, dressed him as an officer of the Royal Marines and placed personal items on him identifying him as the fictitious Captain (Acting Major) William Martin.
Bitwise operation In computer programming, a bitwise operation operates on a bit string, a bit array or a binary numeral (considered as a bit string) at the level of its individual bits. It is a fast and simple action, basic to the higher-level arithmetic operations and directly supported by the processor.
Special Activities Center The Special Activities Center (SAC) is a division of the Central Intelligence Agency responsible for covert operations and paramilitary operations. The unit was named Special Activities Division (SAD) prior to 2015.
Operations management Operations management is an area of management concerned with designing and controlling the process of production and redesigning business operations in the production of goods or services. It involves the responsibility of ensuring that business operations are efficient in terms of using as few resources as needed and effective in meeting customer requirements.
Emergency operations center An emergency operations center (EOC) is a central command and control facility responsible for carrying out the principles of emergency preparedness and emergency management, or disaster management functions at a strategic level during an emergency, and ensuring the continuity of operation of a company, political subdivision or other organization.\nAn EOC is responsible for strategic direction and operational decisions and does not normally directly control field assets, instead leaving tactical decisions to lower commands.
Surgery Surgery is a medical or dental specialty that uses operative manual and instrumental techniques on a person to investigate or treat a pathological condition such as a disease or injury, to help improve bodily function, appearance, or to repair unwanted ruptured areas.\nThe act of performing surgery may be called a surgical procedure, operation, or simply "surgery".
Special operations Special operations (S.O.) are military activities conducted, according to NATO, by "specially designated, organized, selected, trained, and equipped forces using unconventional techniques and modes of employment". Special operations may include reconnaissance, unconventional warfare, and counter-terrorism actions, and are typically conducted by small groups of highly-trained personnel, emphasizing sufficiency, stealth, speed, and tactical coordination, commonly known as "special forces".
Operations research Operations research (British English: operational research), often shortened to the initialism OR, is a discipline that deals with the development and application of advanced analytical methods to improve decision-making. It is sometimes considered to be a subfield of mathematical sciences.
Abbott Laboratories Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products.
Medical device design Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.\n\n\n== Medical device design in the United States ==\nThe United States medical device industry is one of the largest markets globally, exceeding $110 billion annually.
Significant other The term significant other (SO) has different uses in psychology and in colloquial language. Colloquially "significant other" is used as a gender-neutral term for a person's partner in an intimate relationship without disclosing or presuming anything about marital status, relationship status, gender identity, or sexual orientation.
Bit numbering In computing, bit numbering is the convention used to identify the bit positions in a binary number.\n\n\n== Bit significance and indexing ==\n\nIn computing, the least significant bit (LSB) is the bit position in a binary integer representing the binary 1s place of the integer.
Significant form Significant form refers to an aesthetic theory developed by English art critic Clive Bell which specified a set of criteria for what qualified as a work of art.
Significant Others The term significant other (SO) has different uses in psychology and in colloquial language. Colloquially "significant other" is used as a gender-neutral term for a person's partner in an intimate relationship without disclosing or presuming anything about marital status, relationship status, gender identity, or sexual orientation.
Statistical significance In statistical hypothesis testing, a result has statistical significance when it is very unlikely to have occurred given the null hypothesis. More precisely, a study's defined significance level, denoted by \n \n \n \n α\n \n \n {\displaystyle \alpha }\n , is the probability of the study rejecting the null hypothesis, given that the null hypothesis is true; and the p-value of a result, \n \n \n \n p\n \n \n {\displaystyle p}\n , is the probability of obtaining a result at least as extreme, given that the null hypothesis is true.
The Simpsons The Simpsons is an American animated sitcom created by Matt Groening for the Fox Broadcasting Company. The series is a satirical depiction of American life, epitomized by the Simpson family, which consists of Homer, Marge, Bart, Lisa, and Maggie.
Significant Mother Significant Mother is an American television sitcom created by Erin Cardillo and Richard Keith. Starring Josh Zuckerman, Nathaniel Buzolic and Krista Allen, it premiered on The CW network on August 3 and ended its run on October 5, 2015.
Internet In finance and economics, interest is payment from a borrower or deposit-taking financial institution to a lender or depositor of an amount above repayment of the principal sum (that is, the amount borrowed), at a particular rate. It is distinct from a fee which the borrower may pay the lender or some third party.
Lawsuit A lawsuit is a proceeding by a party or parties against another in the civil court of law. The archaic term "suit in law" is found in only a small number of laws still in effect today.
Intellectual property Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others.
Intellectual property infringement An intellectual property (IP) infringement is the infringement or violation of an intellectual property right. There are several types of intellectual property rights, such as copyrights, patents, trademarks, industrial designs, and trade secrets.
Strategic litigation Strategic litigation, also known as impact litigation, is the practice of bringing lawsuits intended to effect societal change. Impact litigation cases may be class action lawsuits or individual claims with broader significance, and may rely on statutory law arguments or on constitutional claims.
Vexatious litigation Vexatious litigation is legal action which is brought solely to harass or subdue an adversary. It may take the form of a primary frivolous lawsuit or may be the repetitive, burdensome, and unwarranted filing of meritless motions in a matter which is otherwise a meritorious cause of action.
Multidistrict litigation In United States law, multidistrict litigation (MDL) refers to a special federal legal procedure designed to speed the process of handling complex cases, such as air disaster litigation or complex product liability suits.\n\n\n== Description ==\nMDL cases occur when "civil actions involving one or more common questions of fact are pending in different districts." In order to efficiently process cases that could involve hundreds (or thousands) of plaintiffs in dozens of different federal courts that all share common issues, the Judicial Panel on Multidistrict Litigation (JPML) decides whether cases should be consolidated under MDL, and if so, where the cases should be transferred.
Settlement (litigation) In law, a settlement is a resolution between disputing parties about a legal case, reached either before or after court action begins. A collective settlement is a settlement of multiple similar legal cases.
Public interest litigation in India The chief instrument through which judicial activism has flourished in India is Public Interest Litigation (PIL) or Social Action Litigation (SAL). Public interest litigation (PIL) refers to litigation undertaken to secure public interest and demonstrates the availability of justice to socially-disadvantaged parties and was introduced by Justice P. N. Bhagwati.
Public interest law Public interest law refers to legal practices undertaken to help poor, marginalized, or under-represented people, or to effect change in social policies in the public interest, on 'not for profit' terms (pro bono publico), often in the fields of civil rights, civil liberties, religious liberty, human rights, women's rights, consumer rights, environmental protection, and so on.In a celebrated 1905 speech, Louis Brandeis decried the legal profession, complaining that "able lawyers have to a large extent allowed themselves to become adjuncts of great corporations and have neglected their obligation to use their powers for the protection of the people."In the tradition thus exemplified, a common ethic for public-interest lawyers in a growing number of countries remains "fighting for the little guy".\n\n\n== By jurisdiction ==\n\n\n=== Central and Eastern Europe ===\nAt the end of the communist period in the early 1990s, the national legal systems of Central and Eastern Europe were still in a formative stage.
The Review of Litigation The Review of Litigation (TROL) is a law journal established in 1980 at the University of Texas School of Law to serve as "a national forum of interchange of academic and practical discussion of various aspects of litigation." The journal publishes articles on "topics related to procedure, evidence, trial and appellate advocacy, alternative dispute resolution, and often-litigated substantive law."The journal publishes four issues annually, one of which is a symposium issue published in collaboration with the litigation section of American Association of Law Schools. Past topics have included mass torts and conflicts of interest.The journal is often cited in published court opinions, and is the most cited law journal in the category "Civil Litigation and Dispute Resolution" in the Washington & Lee Law School law journal rankings as of 2020.
Risk Factors
BOSTON SCIENTIFIC CORP ITEM 1A RISK FACTORS In addition to the other information contained in this Form 10-K and the exhibits hereto, the following risk factors should be considered carefully in evaluating our business
Our business, financial condition or results of operations could be materially adversely affected by any of these risks
This section contains forward- looking statements
You should refer to the explanation of the qualifications and limitations on forward-looking statements set forth at the beginning of Item 1 of this Form 10-K Additional risks not presently known to us or that we currently deem immaterial may also adversely affect our business, financial condition or results of operations
We also face certain risks in connection with our proposed acquisition of Guidant Corporation as described above in Item 1 of this Form 10-K We encourage you to consider the risks below under the caption &quote —Risks Related to the Proposed Acquisition and Guidant &quote and the risk factors set forth in our registration statement on Form S-4 filed with the SEC on February 6, 2006 (Registration Nodtta 333-131608) for additional risk factors relating to our proposed acquisition of Guidant Corporation
Risks Related to Our Business We are subject to extensive medical device regulation which may impede or hinder the approval process for our products and, in some cases, may not ultimately result in approval or may result in the recall or seizure of previously approved products
Our products, development activities and manufacturing processes are subject to extensive and rigorous regulation by the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (the FDC Act), by comparable agencies in foreign countries, and by other regulatory agencies and governing bodies
Under the FDC Act, medical devices must receive FDA clearance or approval before they can be commercially marketed in the US In addition, most major markets for medical devices outside the US require clearance, approval or compliance with certain standards before a product can be commercially marketed
The process of obtaining marketing approval or clearance from the FDA for new products, or with respect to enhancements or modifications to existing products, could: • take a significant period of time; • require the expenditure of substantial resources; • involve rigorous pre-clinical and clinical testing; • require changes to the products; and • result in limitations on the indicated uses of the products
Even after products have received marketing approval or clearance, product approvals and clearances by the FDA can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval
There can be no assurance that we will receive the required clearances from the FDA for new products or modifications to existing products on a timely basis or that any FDA approval will not be subsequently withdrawn
Later discovery of previously unknown problems with a product or manufacturer could result in fines, delays or suspensions of regulatory clearances, seizures or recalls of products, operating restrictions and/or criminal prosecution
The failure to receive product approval clearance on a timely basis, suspensions of regulatory clearances, seizures or recalls of products or the withdrawal of product approval by the FDA could have a material adverse effect on our business, financial condition or results of operations
22 _________________________________________________________________ We may not meet regulatory quality standards applicable to our manufacturing and quality processes, which could have an adverse effect on our business, financial condition or results of operations
As a device manufacturer, we are required to register with the FDA and are subject to periodic inspection by the FDA for compliance with the FDAapstas Quality System Regulation (QSR) requirements, which require manufacturers of medical devices to adhere to certain regulations, including testing, quality control and documentation procedures
In addition, the federal Medical Device Reporting regulations require us to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have caused or contributed to a death or serious injury or, if a malfunction were to occur, could cause or contribute to a death or serious injury
Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the FDA In the European Community, we are required to maintain certain ISO certifications in order to sell our products and must undergo periodic inspections by notified bodies to obtain and maintain these certifications
In that regard, we are currently taking remedial action in response to certain deficiencies of our quality systems as cited by the FDA in FDA warning letters to us
For example, we received several warning letters from the FDA in 2005 with respect to our global quality-control systems and in 2004 with respect to our auditory product line
In addition, on January 26, 2006, we received a corporate warning letter from the FDA notifying us of serious regulatory problems at three facilities and advising us that our corporate wide corrective action plan relating to three warning letters previously issued to us in 2005 was inadequate
As also stated in this FDA warning letter, the FDA will not grant our requests for exportation certificates to foreign governments or approve pre-market approval applications for our class III devices to which the quality control or current good manufacturing practices deficiencies described in the letter are reasonably related until the deficiencies described in the letter have been corrected
If we are unable to resolve the issues raised by the FDA in its warning letters to the satisfaction of the FDA on a timely basis, we may not be able able to launch our new class III devices as planned, including our Taxus® Liberte™ drug-eluting stent system in the United States in the second half of 2006
We may face enforcement actions in connection with these FDA warning letters, including injunctive relief and civil fines
While we are working with the FDA to resolve these issues, this work has required and will continue to require the dedication of significant incremental internal and external resources
There can be no assurances regarding the length of time it will take to resolve these issues
In addition, if our remedial actions are not satisfactory to the FDA, the FDA may take further regulatory actions against us, including but not limited to, seizing our product inventory, obtaining a court injunction against further marketing of our products or assessing civil monetary penalties
If we or our manufacturers fail to adhere to QSR or ISO requirements, this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances, recalls or other consequences, which could in turn have a material adverse effect on our financial condition or results of operations
Pending and future intellectual property litigation could be costly and disruptive to us
We operate in an industry that is susceptible to significant intellectual property litigation and, in recent years, it has been common for companies in the medical device field to aggressively challenge the patent rights of other companies in order to prevent the marketing of new devices
We are currently the subject of various patent litigation proceedings, including the proceedings described in more detail under Item 3
Legal Proceedings
Intellectual property litigation is expensive, complex and lengthy and its outcome is difficult to predict
Pending or future patent litigation may result in significant royalty or other payments or injunctions that can prevent the sale of products and may significantly divert the attention of our technical and management personnel
In the event that our right to market any of our products is successfully challenged, and if we fail to obtain a required license 23 _________________________________________________________________ or are unable to design around a patent, our business, financial condition or results of operations could be materially adversely affected
We may not be able effectively to protect our intellectual property rights which could have an adverse effect on our business, financial condition or results of operations
The interventional medicine market in which we primarily participate is in large part technology driven
Physician customers, particularly in interventional cardiology, move quickly to new products and new technologies
As a result, intellectual property rights, particularly patents and trade secrets, play a significant role in product development and differentiation
However, intellectual property litigation to defend or create market advantage is inherently complex and unpredictable
Furthermore, appellate courts frequently overturn lower court patent decisions
In addition, competing parties frequently file multiple suits to leverage patent portfolios across product lines, technologies and geographies and to balance risk and exposure between the parties
In some cases, several competitors are parties in the same proceeding, or in a series of related proceedings, or litigate multiple features of a single class of devices
These forces frequently drive settlement not only of individual cases, but also of a series of pending and potentially related and unrelated cases
In addition, although monetary and injunctive relief is typically sought, remedies and restitution are generally not determined until the conclusion of the proceedings and are frequently modified on appeal
Accordingly, the outcomes of individual cases are difficult to time, predict or quantify and are often dependent upon the outcomes of other cases in other geographies
Several third parties have asserted that our current and former stent systems infringe patents owned or licensed by them
We have similarly asserted that stent systems or other products sold by these companies infringe patents owned or licensed by us
Adverse outcomes in one or more of these proceedings against us could limit our ability to sell certain stent products in certain jurisdictions, or reduce our operating margin on the sale of these products
In addition, damage awards related to historical sales could be material
Patents and other proprietary rights are and will be essential to our business, and our ability to compete effectively with other companies will be dependent upon the proprietary nature of our technologies
We rely upon trade secrets, know-how, continuing technological innovations, strategic alliances and licensing opportunities to develop, maintain and strengthen our competitive position
We pursue a policy of generally obtaining patent protection in both the US and abroad for patentable subject matter in our proprietary devices and also attempt to review third-party patents and patent applications to the extent publicly available to develop an effective patent strategy, avoid infringement of third-party patents, identify licensing opportunities and monitor the patent claims of others
We currently own numerous US and foreign patents and have numerous patent applications pending
We also are party to various license agreements pursuant to which patent rights have been obtained or granted in consideration for cash, cross-licensing rights or royalty payments
No assurance can be made that any pending or future patent applications will result in issued patents, that any current or future patents issued to, or licensed by, us will not be challenged or circumvented by our competitors, or that our patents will not be found invalid
In addition, we may have to take legal action in the future to protect our patents, trade secrets or know-how or to assert them against claimed infringement by others
Any legal action of that type could be costly and time consuming to us and no assurances can be made that any lawsuit will be successful
We are generally involved as both a plaintiff and a defendant in a number of patent infringement and other intellectual property-related actions
We are involved in numerous patent-related claims with our competitors, including Johnson & Johnson
24 _________________________________________________________________ The invalidation of key patents or proprietary rights that we own, or an unsuccessful outcome in lawsuits to protect our intellectual property, could have a material adverse effect on our business, financial position or results of operations
Pending and future product liability claims and other litigation, including private securities litigation and shareholder derivative suits, may adversely affect our business, reputation and ability to attract and retain customers
The design, manufacture and marketing of medical devices of the types that we produce entail an inherent risk of product liability claims
Many of the medical devices that we manufacture and sell are designed to be implanted in the human body for long periods of time or indefinitely
A number of factors could result in an unsafe condition or injury to, or death of, a patient with respect to these or other products that we manufacture or sell, including component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks or product-related information
These factors could result in product liability claims, a recall of one or more of our products or a safety alert relating to one or more of our products
Product liability claims may be brought by individuals or by groups seeking to represent a class
We are currently the subject of numerous product liability claims and other litigation, including private securities litigation and shareholder derivative suits including, but not limited to, the claims and