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Prenuptial agreement A prenuptial agreement, antenuptial agreement, or premarital agreement (commonly referred to as a prenup), is a written contract entered into by a couple prior to marriage or a civil union that enables them to select and control many of the legal rights they acquire upon marrying, and what happens when their marriage eventually ends by death or divorce. Couples enter into a written prenuptial agreement to supersede many of the default marital laws that would otherwise apply in the event of divorce, such as the laws that govern the division of property, retirement benefits, savings, and the right to seek alimony (spousal support) with agreed-upon terms that provide certainty and clarify their marital rights.
TRIPS Agreement The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to nationals of other WTO member nations.
Non-disclosure agreement A non-disclosure agreement (NDA), also known as a confidentiality agreement (CA), confidential disclosure agreement (CDA), proprietary information agreement (PIA), secrecy agreement (SA), or non-disparagement agreement, is a legal contract or part of a contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to. Doctor–patient confidentiality (physician–patient privilege), attorney–client privilege, priest–penitent privilege and bank–client confidentiality agreements are examples of NDAs, which are often not enshrined in a written contract between the parties.
Minsk agreements The Minsk agreements were a series of international agreements which sought to end the war in the Donbas region of Ukraine. The first, known as the Minsk Protocol, was drafted in 2014 by the Trilateral Contact Group on Ukraine, consisting of Ukraine, Russia, and the Organization for Security and Co-operation in Europe (OSCE), with mediation by the leaders of France and Germany in the so-called Normandy Format.
Veterinarian A veterinarian (vet), also known as a veterinary surgeon or veterinary physician, is a medical professional who practices veterinary medicine. They manage a wide range of health conditions and injuries in non-human animals.
Consumables Consumables (also known as consumable goods, non-durable goods, or soft goods) are goods that are intended to be consumed. People have, for example, always consumed food and water.
Consumed Consumables (also known as consumable goods, non-durable goods, or soft goods) are goods that are intended to be consumed. People have, for example, always consumed food and water.
Consumability A concept recently championed by International Business Machines (IBM), consumability is a description of customers' end-to-end experience with technology solutions (although the concept could easily apply to almost anything). The tasks associated with consumability start before the consumer purchases a product and continue until the customer stops using the product.
List of countries by oil consumption This is a list of countries by oil consumption.\nIn 2020 total worldwide oil consumption is expected to drop by 9% year over year compared to 2019 due to the COVID-19 pandemic according to the International Energy Agency (IEA).
Consuming Impulse Consuming Impulse (stylized as Consvming Impvlse) is the second album by Dutch death metal band Pestilence, released in 1989. While retaining some of the thrash metal elements from its predecessor Malleus Maleficarum (1988), Consuming Impulse saw the band progress further towards the traditional death metal genre with progressive influences; this can be seen as one of the earliest examples of technical death metal, a subgenre that would be used and expanded on Pestilence's subsequent albums.
Consumed (novel) Consumed is the first novel by the Canadian filmmaker, screenwriter and actor David Cronenberg. The novel is driven by a globe-trotting, photojournalist couple, that pursue stories featuring rather unusual people.
The Consuming Flame The Consuming Flame: Open Exercises in Group Form is the twelfth studio album by experimental electronic music duo Matmos, released on August 21, 2020 through Thrill Jockey.\n\n\n== Critical reception ==\nThe Consuming Flame received "universal acclaim" according to album review aggregator Metacritic.
Commercial cleaning Commercial cleaning companies are contracted to carry out cleaning jobs in a variety of premises.\n\n\n== Cleaning techniques and equipment ==\n\nCommercial office cleaning companies use a wide variety of cleaning methods, chemicals, and equipment to facilitate and expedite the cleaning process.
Competition Competition is a rivalry where two or more parties strive for a common goal which cannot be shared: where one's gain is the other's loss (an example of which is a zero-sum game). Competition can arise between entities such as organisms, individuals, economic and social groups, etc.
Veterinary medicine Veterinary medicine is the branch of medicine that deals with the prevention, control, diagnosis, and treatment of disease, disorder, and injury in animals. Along with this, it deals with animal rearing, husbandry, breeding, research on nutrition, and product development.
Pharmaceutical industry The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices.
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.
Automotive industry The automotive industry comprises a wide range of companies and organizations involved in the design, development, manufacturing, marketing, and selling of motor vehicles. It is one of the world's largest industries by revenue (from 16 % such as in France up to 40 % to countries like Slovakia).
Veterinary specialties A veterinary specialist is a veterinarian who specializes in a clinical field of veterinary medicine.\nA veterinary specialist may be consulted when an animal's condition requires specialized care above and beyond that which a regular veterinarian can offer.
Veterinary surgery Veterinary surgery is surgery performed on animals by veterinarians, whereby the procedures fall into three broad categories: orthopaedics (bones, joints, muscles), soft tissue surgery (skin, body cavities, cardiovascular system, GI/urogenital/respiratory tracts), and neurosurgery. Advanced surgical procedures such as joint replacement (total hip, knee and elbow replacement), fracture repair, stabilization of cranial cruciate ligament deficiency, oncologic (cancer) surgery, herniated disc treatment, complicated gastrointestinal or urogenital procedures, kidney transplant, skin grafts, complicated wound management, and minimally invasive procedures (arthroscopy, laparoscopy, thoracoscopy) are performed by veterinary surgeons (as registered in their jurisdiction).
Veterinary obstetrics Veterinary obstetrics are the obstetrical methods used in veterinary medicine, which are quite different from those of human medicine. Veterinary obstetrics is a branch of veterinary medicine that deals with medical and surgical care together with manipulations of the female animals in breeding, gestation, labor, puerperium (postpartum period), and care of the newborn.
Veterinary pathology Veterinary pathologists are veterinarians who specialize in the diagnosis of diseases through the examination of animal tissue and body fluids. Like medical pathology, veterinary pathology is divided into two branches, anatomical pathology and clinical pathology.
List of schools of veterinary medicine This is a list of veterinary schools throughout the world by country.\n\n\n== Afghanistan ==\nKabul University Veterinary Science Faculty\nHerat University Veterinary Science Faculty\nNangarhar University Veterinary Science Faculty\nKunduz University Veterinary Science Faculty\nKhost University Veterinary Science Faculty\nMazar-e-Sharif University Veterinary Science Faculty\nHelman University Veterinary Science Faculty\nKandahar University Veterinary Science Faculty\nBamyan University Veterinary Science Department\n\n\n== Albania ==\nAgricultural University of Tirana Faculty of Veterinary Medicine\nWorldWide University Veterinary Science Programme\n\n\n== Algeria ==\nHigher National Veterinary School\nSaad Dahlab University of Blida Department of Veterinary Sciences\nUniversity of Batna Veterinary Department\nUniversity of Ibn Khaldoun, Tiaret\nUniversity of Mentouri – Constantine Faculty of Natural and Life Sciences\nUniversity of Taref Veterinary Departement\n\n\n== Angola ==\nJosé Eduardo dos Santos University Faculty of Veterinary Medicine\n\n\n== Argentina ==\nCatholic University of Cordoba Faculty of Agricultural and Veterinary Sciences\nCatholic University of Cuyo, San Luis campus Faculty of Veterinary Sciences\nJuan Agustín Maza University Faculty of Veterinary and Environmental Sciences\nNational University of Central Buenos Aires Faculty of Veterinary Sciences\nNational University of La Pampa Faculty of Veterinary Sciences\nNational University of La Plata Faculty of Veterinary Sciences\nNational University of the Littoral Faculty of Veterinary Sciences\nNational University of the Northeast Faculty of Veterinary Sciences\nNational University of Río Cuarto Faculty of Agronomy and Veterinary Sciences\nNational University of Rosario Faculty of Veterinary Sciences\nNational University of Tucumán Faculty of Veterinary Sciences\nUniversity of Buenos Aires Faculty of Veterinary Sciences\nUniversity of El Salvador Veterinary Medicine Course\nNational University of Villa María Instituto Académico Pedagógico de Ciencias Básicas y Applicadas\n\n\n== Australia ==\nAustralia has seven schools of veterinary medicine:\n\nCharles Sturt University School of Animal and Veterinary Sciences\nJames Cook University, College of Public Health, Medical and Veterinary Sciences\nMurdoch University School of Veterinary and Life Sciences\nUniversity of Adelaide School of Veterinary Science\nUniversity of Melbourne Melbourne Veterinary School\nUniversity of Queensland School of Veterinary Science\nUniversity of Sydney Faculty of Veterinary Science\n\n\n== Austria ==\nUniversity of Veterinary Medicine Vienna\n\n\n== Bangladesh ==\nBangladesh Agricultural University Faculty of Veterinary Science\nSylhet Agricultural University Faculty of Veterinary, Animal and Biomedical Sciences\nBangabandhu Sheikh Mujibur Rahman Agricultural University Faculty of Veterinary Medicine and Animal Science\nChittagong Veterinary and Animal Sciences University\nHajee Mohammad Danesh Science & Technology University Faculty of Veterinary & Animal Science\nPatuakhali Science and Technology University Faculty of Animal science and veterinary medicine, Barishal campus\nJhenaidah Government Veterinary College, Jhenidah, Bangladesh\nRajshahi University Faculty of Veterinary & Animal Sciences\nSher-e-Bangla Agricultural University Faculty of Animal Science and Veterinary Medicine\nGono University Faculty of Veterinary & Animal Sciences(Private University)\nKhulna Agricultural University, khulna\nSirajganj Government Veterinary college\nBangabandhu Sheikh Mujibur Rahman Science and Technology University, Gopalganj\n\n\n== Belarus ==\nGorkovskii Agricultural Institute\nVitebsk State Academy of Veterinary Medicine\n\n\n== Belgium ==\nFaculty of Veterinary Medicine, University of Liège, Liège\nFaculty of Veterinary Medicine, Ghent University, Ghent\nSchool of Veterinary Medicine, Faculty of Science, UCLouvain, Louvain-la-Neuve (undergraduate only)\nFaculty of Medicine, Université libre de Bruxelles, Anderlecht (undergraduate only)\n\nFaculty of Pharmaceutical, Biomedial, and Veterinary Science, University of Antwerp, Antwerp (undergraduate only)\n\n\n== Bolivia ==\nAutonomous University of Beni "José Ballivián" Faculty of Livestock Sciences\nGabriel René Moreno Autonomous University Veterinary Sciences Faculty\n\n\n== Bosnia and Herzegovina ==\nUniversity of Sarajevo Veterinary Faculty\n\n\n== Brazil ==\nFederal University of Bahia\nCenter of Higher Teaching of Campos Gerais Veterinary Medicine\nFederal University of Goiás Veterinary and Husbandry School\nFederal University of Lavras Department of Veterinary Medicine\nFederal University of Minas Gerais\nFederal University of Pampa\nFederal University of Paraíba Center of Agricultural Sciences\nFederal University of Paraná\nFederal University of Pelotas College of Veterinary Medicine\nFederal University of Pernambuco\nFederal University of Rio Grande do Sul Faculty of Veterinary Sciences\nFederal University of Santa Maria Veterinary Medicine\nFederal University of Viçosa Veterinary Department\nFluminense Federal University\nPaulista Júlio State University of Mesquita Filho, Botucatu campus Faculty of Veterinary Medicine and Husbandry\nPaulista Júlio State University of Mesquita Filho, Jaboticabal campus Faculty of Veterinary Medicine and Husbandry\nPontifical Catholic University of Paraná School of Agriculture and Veterinary Medicine\nRural Federal University of Rio de Janeiro\nSanta Catarina State University Veterinary and Agricultural Center\nUniversidade Estadual de Maringá\nUNICENTRO – Universidade Estadual do Centro-Oeste do Paraná\nUniversity of Brasília Faculty of Agronomy and Veterinary Medicine\nUniversity of São Paulo Faculty of Veterinary Medicine\nVila Velha University\nUniversidade Estadual do Ceará/ Faculdade de Veterinária (UECE/FAVET)\n\n\n== Bulgaria ==\nTrakia University Faculty of Veterinary Medicine\nUniversity of Forestry, Sofia Faculty of Veterinary Medicine\n\n\n== Canada ==\nCanada has five schools of veterinary medicine:\n\nAtlantic Veterinary College, University of Prince Edward Island\nOntario Veterinary College, University of Guelph\nUniversité de Montréal Faculty of Veterinary Medicine\nUniversity of Calgary Faculty of Veterinary Medicine\nWestern College of Veterinary Medicine, University of Saskatchewan\n\n\n== Chile ==\nAustral University of Chile Faculty of Veterinary Sciences\nMayor University Veterinary Medicine\nSan Sebastián University Veterinary Medicine\nSanto Tomás University Veterinary Medicine\nUniversity of the Americas Faculty of Veterinary Medicine and Agronomy\nUniversity of Chile Faculty of Veterinary Sciences and Livestock\nUniversity of Concepción Faculty of Veterinary Sciences\n\n\n== China ==\nCollege of Animal Husbandry and Veterinary Medicine Shenyang Agricultural University China\nCollege of Animal Science and Technology Anhui Agricultural University Hefei city China\nCollege of Animal Science and Technology Animal diseases institute China\nCollege of Animal Science and Veterinary Medicine Heilongjiang Bayi Agricultural University China\nCollege of Animal Science and Veterinary Medicine Shanxi Agricultural University China\nCollege of Veterinary Medicine HeBei Agricultural China\nCollege of Veterinary Medicine Huazhong Agricultural University China\nCollege of Veterinary Medicine Northwest A&F University China\nCollege of Veterinary Medicine Southwest Uniwersity China\nDepartment of Animal Medicine Agricultural college of Yanbian Uniweisity China\nLife Science and Engineering College Northwest University for Nationalities China\nVeterinary College Northeast Agricultural University China\nVeterinary Medicine Department, College of Life Science and Technology Southwest University for nationalities China\nAnimal science and veterinary medicine college Tianjin agricultural University China\nChina Agricultural University College of Veterinary Medicine Beijing China\nCollege of Animal Science and Technolog Guangxi University China\nCollege of Animal Science and Technolog Qingdao Agricultural University China\nCollege of Animal science and technology HeNan University of science and technology China\nCollege of Animal Science and Veterinary Medicine Henan institute of science and technology China\nCollege of Animal Science/Veterinary Medicine Shandong Agricultural University China\nCollege of Veterinary Medicine Inner Mongolia Agricultural University China\nCollege of Veterinary Medicine Jiangxi Agricultural University China\nCollege of Veterinary Medicine Yangzhou University China\nCollege of Veterinary Medicine, South China Agricultural University China\nCollege of Veterinary Medicine.Sicau Sichuan Agriculture University China\nHenan Agricultural University, College of Animal Husbandry and Veterinary Science Henan China\nHuazhong Agricultural University, College of Veterinary Medicine Wuhan · Hubei Province China\nJiangsu–Yangzhou University, College of Veterinary Medicine Yangzhou, Jiangsu China * The College of Veterinary Medicine at Nanjing Agricultural University (NAU) China\nZhejiang Agricultural University College of Animal Science & Veterinary Medicine Hangzhou China\n\n\n== Costa Rica ==\nEscuela de Medicina y Cirugía Veterinaria San Francisco de Asís, Universidad Veritas\nNational University of Costa Rica School of Veterinary Medicine\n\n\n== Croatia ==\nUniversity of Zagreb Faculty of Veterinary Medicine\n\n\n== Czech Republic ==\nUniversity of Veterinary and Pharmaceutical Sciences Brno\n\n\n== Denmark ==\nRoyal Veterinary and Agricultural University (1856–2007)\nUCPH School of Veterinary Medicine and Animal Science (2012–)\n\n\n== Dominica ==\nSt.
Medication Meditation is a practice in which an individual uses a technique – such as mindfulness, or focusing the mind on a particular object, thought, or activity – to train attention and awareness, and achieve a mentally clear and emotionally calm and stable state.Meditation is practiced in numerous religious traditions. The earliest records of meditation (dhyana) are found in the Upanishads of Hindu philosophy, and meditation plays a salient role in the contemplative repertoire of Buddhism and Hinduism.
Teva Pharmaceuticals Teva Pharmaceutical Industries Ltd. (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company with headquarters in Petah Tikva, Israel.
Pharmaceutics Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design.
Grasshopper Manufacture Grasshopper Manufacture Inc. (株式会社グラスホッパー・マニファクチュア, Kabushiki Gaisha Gurasuhoppā Manifakuchua) is a Japanese video game developer founded on March 30, 1998 by Goichi Suda.
Manufacture d'horlogerie Manufacture d'horlogerie (meaning "watchmaking manufacturer") is a French language term of horology that has also been adopted in the English language as a loanword. In horology, the term is usually encountered in its abbreviated form manufacture.
Gobelins Manufactory The Gobelins Manufactory (French: Manufacture des Gobelins) is a historic tapestry factory in Paris, France. It is located at 42 avenue des Gobelins, near Les Gobelins métro station in the 13th arrondissement of Paris.
Build-on-demand Build-on-demand or manufacturing on demand (MOD) refers to a manufacturing process where goods are produced only when or as they are required. This allows scalability and adjustable assemblies depending on the current needs of the part requestor or client.
Manufacture nationale de Sèvres The Manufacture nationale de Sèvres is one of the principal European porcelain factories. It is located in Sèvres, Hauts-de-Seine, France.
Design for manufacturability Design for manufacturability (also sometimes known as design for manufacturing or DFM) is the general engineering practice of designing products in such a way that they are easy to manufacture. The concept exists in almost all engineering disciplines, but the implementation differs widely depending on the manufacturing technology.
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.
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.
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.
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.
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".
Risk Factors
IDEXX LABORATORIES INC /DE Item 1A Risk Factors
” 6 _________________________________________________________________ PRODUCTION AND SUPPLY VetTest^® Chemistry Analyzers are manufactured for us by Tokyo Parts Industrial Company, Ltd
under an agreement that renews annually unless either party notifies the other of its decision not to renew
VetTest^® slides are supplied exclusively by Ortho under supply agreements with Ortho (the “Ortho Agreements”)
We are required to purchase all of our requirements for our current menu of VetTest^® slides from Ortho to the extent Ortho is able to supply those requirements
In addition, we have committed to minimum annual purchase volumes of certain VetTest^® slides through 2010
The Ortho Agreements expire on December 31, 2020
The VetAutoread™ Hematology Analyzer is manufactured for us by QBC Diagnostics, Inc
(“QBCD”) under a supply agreement that expires on December 31, 2020
The VetLyte^® Electrolyte Analyzer is manufactured for us by Roche Diagnostics Corporation under an agreement that requires Roche Diagnostics to supply analyzers through December 31, 2006, and consumables and spare parts through December 31, 2013
The VetStat™ Electrolyte and Blood Gas Analyzer is manufactured for us by Osmetech, Inc
under an agreement that requires Osmetech to supply analyzers and consumables through 2015 and we have an option to extend this agreement for an additional four years
We have certain minimum purchase obligations under these agreements
We purchase certain other products, raw materials and components from a single supplier
These include active ingredients for our pharmaceutical products, certain digital radiography systems, instrument consumables, and certain components used in our SNAP^® rapid assay devices, water testing products and LaserCyte^® Hematology Analyzers
We have in the past been successful in ensuring an uninterrupted supply of products purchased from single source suppliers
However, there can be no assurance that uninterrupted supply can be maintained if these agreements terminate for any reason or our suppliers otherwise are unable to satisfy our requirements for products
We do not generally maintain significant backlog and believe that our backlog at any particular date historically has not been indicative of future sales
COMPETITION We face intense competition within the markets in which we sell our products and services
We expect that future competition will become even more intense, and that we will have to compete with changing technologies, which could affect the marketability of our products and services
Our competitive position also will depend on our ability to develop proprietary products, attract and retain qualified scientific and other personnel, develop and implement production and marketing plans, obtain or license patent rights, and obtain adequate capital resources
We compete with many companies ranging from small businesses focused on animal health to large pharmaceutical companies
Our competitors vary in our different markets
Academic institutions, governmental agencies and other public and private research organizations also conduct research activities and may commercialize products, which could compete with our products, on their own or through joint ventures
Some of our competitors have substantially greater capital, manufacturing, marketing, and research and development resources than we do
Competitive factors in our different business areas are detailed below: • Veterinary diagnostic products and food and water testing products
We compete primarily on the basis of the ease of use, speed, accuracy and other performance characteristics of our products and services (including unique tests), the breadth of our product line and services, the effectiveness of our sales and distribution channels, the quality of our technical and customer service, and our pricing relative to the value of our products
Veterinary laboratory and consulting services
In this market, we compete primarily on the basis of quality, service, technology, and our pricing relative to the value of our services
We compete in certain geographic locations in the US with Antech Diagnostics, a unit of VCA Antech, Inc
Veterinary pharmaceuticals
We compete primarily on the basis of the performance characteristics of our products
We compete primarily on the basis of ease of use, connectivity to equipment and other systems, performance characteristics, effectiveness of our customer service, information handling capabilities, advances in technologies, and our pricing relative to the value of our products and services
7 _________________________________________________________________ GOVERNMENT REGULATION Many of our products are subject to regulation by US and foreign regulatory agencies
The following is a description of the principal regulations affecting our businesses
Veterinary diagnostic products
Most diagnostic tests for animal health applications are veterinary biological products that are regulated in the US by the Center for Veterinary Biologics within the USDA Animal and Plant Health Inspection Service (“APHIS”)
The APHIS regulatory approval process involves the submission of product performance data and manufacturing documentation
Following regulatory approval to market a product, APHIS requires that each lot of product be submitted for review before release to customers
In addition, APHIS requires special approval to market products where test results are used in part for government-mandated disease management programs
A number of foreign governments accept APHIS approval as part of their separate regulatory approvals
However, compliance with an extensive regulatory process is required in connection with marketing diagnostic products in Japan, Germany, the Netherlands and many other countries
We also are required to have a facility license from APHIS to manufacture USDA-licensed products
We have obtained such a license for our manufacturing facility in Westbrook, Maine and Memphis, Tennessee
Our instrument systems are medical devices regulated by the US Food and Drug Administration (“FDA”) under the Food, Drug and Cosmetics Act (the “FDC Act”)
While the sale of these products does not require premarket approval by FDA and does not subject us to the FDA’s Good Manufacturing Practices regulations (“GMPs”), these products must not be adulterated or misbranded under the FDC Act
Veterinary pharmaceuticals
The manufacture and sale of veterinary pharmaceuticals are regulated by the Center for Veterinary Medicine (“CVM”) of the FDA A new animal drug may not be commercially marketed in the US unless it has been approved as safe and effective by CVM Approval may be requested by filing an NADA with CVM containing substantial evidence as to the safety and effectiveness of the drug
Data regarding manufacturing methods and controls also are required to be submitted with the NADA Manufacturers of animal drugs must also comply with GMPs and Good Laboratory Practices (“GLPs”)
Sales of animal drugs in countries outside the US require compliance with the laws of those countries, which may be extensive
Water testing products
Our water tests are not subject to formal premarket regulatory approval
However, before a test can be used as part of a water-quality monitoring program in the US that is required by the EPA, the test must first be approved by the EPA The EPA approval process involves submission of extensive product performance data in accordance with an EPA-approved protocol, evaluation of the data by the EPA and publication for public comment of any proposed approval in the Federal Register before final approval
Our Colilert®, Colilert®-18, Colisure®, Quanti-Tray®, Filta-Max® and SimPlate® for heterotropic plate counts (“HPC”) products have been approved by the EPA The sale of water-testing products also is subject to extensive and lengthy regulatory processes in many other countries around the world
Dairy testing products
The sale of dairy testing products in the US is regulated by the FDA in conjunction with the AOAC Research Institute (“AOAC RI”)
Before a product can be sold, extensive product performance data must be submitted in accordance with a protocol that is approved by the FDA and the AOAC RI Following approval of a product by the FDA, the product must also be approved by the National Conference on Interstate Milk Shipments (“NCIMS”), an oversight body that includes state, federal and industry representatives
Our dairy antibiotic residue testing products have been approved by the FDA and NCIMS While some foreign countries accept AOAC RI approval as part of their regulatory approval process, many countries have separate regulatory processes
Any acquisitions of new products and technologies may subject us to additional areas of government regulation
These may involve food, drug and water-quality regulations of the FDA, the EPA and the USDA, as well as state, local and foreign governments
See “Part I, Item 1A Risk Factors
We are not a party to any collective bargaining agreement and we believe that relations with our employees are good
8 _________________________________________________________________ ITEM 1A RISK FACTORS Our future operating results involve a number of risks and uncertainties
Actual events or results may differ materially from those discussed in this report
Factors that could cause or contribute to such differences include, but are not limited to, the factors discussed below, as well as those discussed elsewhere in this report
IDEXXapstas Future Growth and Profitability Depend on Several Factors The future success of our business depends upon our ability to successfully implement various strategies, including: • Developing, manufacturing and marketing new products with new features and capabilities, including pharmaceutical products; a new clinical chemistry instrument; and rapid assay, water testing and production animal diagnostic products, as well as improving and enhancing existing products; • Developing and implementing new technology and licensing strategies; and identifying, completing and integrating acquisitions that enhance our existing businesses or create new business areas for us; • Increasing the value to our customers of our companion animal products and services by enhancing the connectivity of these products, including the connectivity among the IDEXX VetLab^® instrument suite, Cornerstone^® practice information management system, the IDEXX-PACS™ software and IDEXX Reference Laboratories; • Expanding our market by expanding the installed base of our instrumentation through customer acquisition and retention and increasing use of our products by our customers; • Strengthening our sales and marketing activities both within the US and in geographies outside of the US; and • Reducing the costs of manufacturing our products and providing services through operating efficiencies and increased focus on quality
However, we may not be able to successfully implement some or all of these strategies and increase or sustain our rate of growth or profitability
Our Products and Services Are Subject to Various Government Regulations In the US, the manufacture and sale of our products are regulated by agencies such as the US Department of Agriculture (“USDA”), US Food and Drug Administration (“FDA”) and the US Environmental Protection Agency (“EPA”)
Most diagnostic tests for animal health applications, including our canine, feline, poultry and livestock tests, must be approved by the USDA prior to sale
Our water testing products must be approved by the EPA before they can be used by customers in the US as a part of a water quality monitoring program required by the EPA Our pharmaceutical and dairy testing products require approval by the FDA The manufacture and sale of our products are subject to similar laws in many foreign countries
Any failure to comply with legal and regulatory requirements relating to the manufacture and sale of our products in the US or in other countries could result in fines and sanctions against us or removals of our products from the market, which could have a material adverse effect on our results of operations
We have entered into an agreement with the FDA under which we have agreed, among other things, to perform specified lot release and stability testing of our SNAP® beta-lactam dairy-testing products and to provide related data to the FDA If the FDA were to determine that one or more lots of product failed to meet applicable criteria for product performance or stability, the FDA could take various actions, including requiring us to recall products or restricting our ability to sell these products
Sales of dairy antibiotic residue-testing products were dlra15dtta6 million for the year ended December 31, 2005
Commercialization of animal health pharmaceuticals in the US requires prior approval by the FDA To obtain such approvals, we are required to submit substantial clinical, manufacturing and other data to the FDA Regulatory approval for products submitted to the FDA may take several years and, following approval, the FDA continues to regulate all aspects of the manufacture, labeling, storage, record keeping and promotion of pharmaceutical products
Failure to obtain, or delays in obtaining, FDA approval for new pharmaceutical products would have a negative impact on our future growth
9 _________________________________________________________________ We Purchase Materials for Our Products from a Limited Number of Sources We currently purchase many products and materials from single sources or a limited number of sources
Some of the products that we purchase from these sources are proprietary, and, therefore, cannot be readily replaced by alternative sources
These products include our VetTest^® Chemistry, VetAutoread™ Hematology, VetLyte^® Electrolyte, and VetStat™ Electrolyte and Blood Gas Analyzers and related consumables; certain digital radiography system components, specifically image capture plates and readers; active ingredients for pharmaceutical products; and certain components of our SNAP^® rapid assay devices, water testing products and LaserCyte^® Hematology Analyzers
If we are unable to obtain adequate quantities of these products in the future, we could face cost increases or reductions or delays in product shipments, which could have a material adverse effect on our results of operations
The slides sold for use in our VetTest^® Chemistry Analyzers are purchased under an agreement with Ortho that, as of December 31, 2005, required us to purchase a minimum of dlra92dtta7 million of slides through 2010
We purchase our electrolyte instruments, components and consumables under an agreement with Roche Diagnostics, under which we are required to purchase a minimum of dlra4dtta1 million of these products through 2006
We purchase our VetAutoread™ Hematology Analyzers, components and consumables under an agreement with QBCD, under which we are required to make aggregate minimum purchases of dlra18dtta0 million through 2020
If demand for any of the products purchased under these agreements is insufficient to support our minimum purchase obligations for those products, we could incur losses related to those obligations
In addition, because we purchase the products at predetermined prices, our profits on sales of these products could decline if we are unable to maintain current pricing levels for such products
Our Biologic Products Are Complex and Difficult to Manufacture Many of our rapid assay and production animal diagnostic products are biologics, which are products that are comprised of materials from living organisms, such as antibodies, cells and sera
Manufacturing biologic products is highly complex
Unlike products that rely on chemicals for efficacy (such as most pharmaceuticals), biologics are difficult to characterize due to the inherent variability of biological input materials
Difficulty in characterizing biological materials or their interactions creates greater risk in the manufacturing process
We attempt to mitigate risk associated with the manufacture of biologics by continuing to improve the characterization of all of our input materials, utilizing multiple vendors, manufacturing some of these materials ourselves and maintaining substantial inventories of materials that have demonstrated the appropriate characteristics
However, there can be no assurance that we will be able to maintain adequate sources of biological materials or that biological materials that we maintain in inventory will yield finished products that satisfy applicable product release criteria
Our inability to obtain necessary biological materials or to successfully manufacture biologic products that incorporate such materials could have a material adverse effect on our results of operations
Our Success Is Heavily Dependent Upon Our Proprietary Technologies We rely on a combination of patent, trade secret, trademark and copyright laws to protect our proprietary rights
If we do not have adequate protection of our proprietary rights, our business may be affected by competitors who develop substantially equivalent technologies that compete with us
We cannot ensure that we will obtain issued patents, that any patents issued or licensed to us will remain valid, or that any patents owned or licensed by us will provide protection against competitors with similar technologies
Even if our patents cover products sold by our competitors, the time and expense of litigating to enforce our patent rights could be substantial, and could have a material adverse effect on our results of operations
In addition, expiration of patent rights could result in substantial new competition in the markets for products previously covered by those patent rights
In the past, we have received notices claiming that our products infringe third-party patents and we may receive such notices in the future
Patent litigation is complex and expensive, and the outcome of patent litigation can be difficult to predict
We cannot ensure that we will win a patent litigation case or negotiate an acceptable resolution of such a case
If we lose, we may be stopped from selling certain products and/or we may be required to pay damages and/or ongoing royalties as a result of the lawsuit
Any such adverse result could have a material adverse effect on our results of operations
10 _________________________________________________________________ Our Sales Are Dependent on Distributor Purchasing Patterns We sell many of our products, including substantially all of the rapid assays and instrument consumables sold in the US, through distributors
Because significant product sales are made to a limited number of customers, unanticipated changes in the timing and size of distributor purchases can have a negative effect on quarterly results
Our financial performance, therefore, is subject to an unexpected downturn in product demand and may be unpredictable
Distributors of veterinary products have entered into business combinations resulting in fewer distribution companies
Consolidation within distribution channels would increase our customer concentration level, which could increase the risks described in the preceding paragraph
Our Markets Are Competitive and Subject to Rapid and Substantial Technological Change We face intense competition within the markets in which we sell our products and services
We expect that future competition will become even more intense, and that we will have to compete with changing and improving technologies
Some of our competitors and potential competitors, including large pharmaceutical and diagnostic companies, have substantially greater capital, manufacturing, marketing, and research and development resources than we do
Changes in Diagnostic Testing Could Negatively Affect Our Operating Results The market for diagnostic tests could be negatively impacted by the introduction or broad market acceptance of vaccines or preventatives for the diseases and conditions for which we sell diagnostic tests and services
Eradication or substantial declines in the prevalence of certain diseases also could lead to a decline in diagnostic testing for such diseases
Our production animal services business in particular is subject to fluctuations resulting from changes in disease prevalence and government-mandated testing programs
Such declines in diagnostic testing could have a material adverse effect on our results of operations
International Revenue Accounts for a Significant Portion of Our Total Revenue For the year ended December 31, 2005, 34prca of our revenue was attributable to sales of products and services to customers outside the US Various risks associated with foreign operations may impact our international sales
Possible risks include fluctuations in the value of foreign currencies, disruptions in transportation of our products, the differing product and service needs of foreign customers, difficulties in building and managing foreign operations, import/export duties and quotas, and unexpected regulatory, economic or political changes in foreign markets
Prices that we charge to foreign customers may be different than the prices we charge for the same products in the US due to competitive, market or other factors
As a result, the mix of domestic and international sales in a particular period could have a material impact on our results for that period
In addition, many of the products for which our selling price may be denominated in foreign currencies are manufactured, sourced, or both, in the US and our costs are incurred in US dollars
We utilize nonspeculative forward currency exchange contracts to mitigate foreign currency exposure, however, an appreciation of the US dollar relative to the foreign currencies in which we sell these products would reduce our operating margins
The Loss of Our President, Chief Executive Officer and Chairman Could Adversely Affect Our Business We rely on the management and leadership of Jonathan W Ayers, our President, Chief Executive Officer and Chairman
We do not maintain key man life insurance coverage for Mr
Ayers could have a material impact on our business
11 _________________________________________________________________ We Could Be Subject to Class Action Litigation Due to Stock Price Volatility, which, if Occurs, Could Result in Substantial Costs or Large Judgments Against Us The market for our common stock may experience extreme price and volume fluctuations, which may be unrelated or disproportionate to our operating performance or prospects
In the past, securities class action litigation has often been brought against companies following periods of volatility in the market prices of their securities
We may be the target of similar litigation in the future
Securities litigation could result in substantial costs and divert our management’s attention and resources, which could have a negative effect on our business, operating results and financial condition
If Our Quarterly Results of Operations Fluctuate, This Fluctuation May Cause Our Stock Price to Decline, Resulting in Losses to You Our prior operating results have fluctuated due to a number of factors, including seasonality of certain product lines; changes in our accounting estimates; the impact of acquisitions; timing of distributor purchases, product launches, research and development expenditures, litigation and claim-related expenditures; changes in competitors’ product offerings; and other matters
Similarly, our future operating results may vary significantly from quarter to quarter due to these and other factors, many of which are beyond our control
If our operating results or projections of future operating results do not meet the expectations of market analysts or investors in future periods, our stock price may fall
Future Operating Results Could Be Materially Affected By the Resolution of Various Uncertain Tax Positions and Adversely Affected by Potential Changes to Tax Incentives In the ordinary course of our business, there are many transactions and calculations where the ultimate tax determination is uncertain
Significant judgment is required in determining our worldwide provision for income taxes and our income tax filings are regularly under audit by tax authorities
We believe that we have adequately accrued for all potential tax liabilities and, although we believe our tax estimates are reasonable, the final determination of tax audits could be materially different than that which is reflected in historical income tax provisions and accruals
Additionally, we benefit from certain tax incentives offered by various jurisdictions
If we are unable to meet the requirements of such incentives, our inability to use these benefits could have a material negative effect on future earnings