Mylan Nv Annual Report 2018

Plain-text annual report

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, DC 20549FORM 10-KþAnnual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2018OR¨Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to .Commission file number 333-199861MYLAN N.V.(Exact name of registrant as specified in its charter)The Netherlands 98-1189497(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, England(Address of principal executive offices)+44 (0) 1707-853-000(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act:Title of Each Class: Name of Each Exchange on Which Registered:Ordinary shares, nominal value €0.01 The NASDAQ Stock MarketSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes þ No ¨Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No þIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past90 days. Yes þ No ¨Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes þ No ¨Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained,to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. þIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.Large accelerated filerþ Accelerated filer ¨Non-accelerated filer¨ Smaller reporting company ¨ Emerging growth company ¨If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ¨ No þThe aggregate market value of the outstanding ordinary shares, nominal value €0.01, of the registrant other than shares held by persons who may be deemed affiliates of theregistrant, as of June 30, 2018, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $18,508,277,080.The number of ordinary shares outstanding, nominal value €0.01, of the registrant as of February 22, 2019 was 515,949,946.INCORPORATED BY REFERENCEDocumentPart of Form 10-K into WhichDocument is IncorporatedAn amendment to this Form 10-K will be filed no later than 120 days after the close of registrant’s fiscal year.III Table of ContentsMYLAN N.V.INDEX TO FORM 10-KFor the Year Ended December 31, 2018 PagePART I ITEM 1.Business3ITEM 1A.Risk Factors14ITEM 1B.Unresolved Staff Comments37ITEM 2.Properties37ITEM 3.Legal Proceedings37 PART II ITEM 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities38ITEM 6.Selected Financial Data40ITEM 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations42ITEM 7A.Quantitative and Qualitative Disclosures about Market Risk67ITEM 8.Financial Statements and Supplementary Data69ITEM 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure158ITEM 9A.Controls and Procedures158ITEM 9B.Other Information158 PART III ITEM 10.Directors, Executive Officers and Corporate Governance159ITEM 11.Executive Compensation159ITEM 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters159ITEM 13.Certain Relationships and Related Transactions, and Director Independence159ITEM 14.Principal Accounting Fees and Services159 PART IV ITEM 15.Exhibits and Consolidated Financial Statement Schedules160Signatures1682Table of ContentsPART IITEM 1.BusinessMylan N.V. (the successor registrant to Mylan Inc.), along with its subsidiaries (collectively, the “Company,” “Mylan,” “our” or “we”), is a globalpharmaceutical company committed to setting new standards in healthcare and providing 7 billion people access to high quality medicine. We offer agrowing portfolio of more than 7,500 products, including prescription generic, branded generic, brand-name drugs and over-the-counter (“OTC”) remedies.We market our products in more than 165 countries and territories. As of December 31, 2018, our global workforce totaled approximately 35,000 employeesand external contractors. Some of our employees are unionized or part of works councils or trade unions.TransformationMylan was founded in 1961 as a privately-owned company to help people in rural communities in the United States (“U.S.”) state of West Virginiaobtain quality affordable medicines. Originally a distributor of other firms’ products, we grew over time into one of the nation’s largest manufacturers ofgeneric drugs (“Gx”). Mylan became a publicly traded company in 1973.Approximately a decade ago, in response to industry changes, Mylan developed and began executing a transformation strategy. Our goal was tocreate a durable business model that would harness the power of competition to drive innovations capable of increasing access to medicine.Our strategy involved creating robust research, manufacturing, supply chain and commercial platforms on a global scale; substantially expandingour portfolio of medicines; diversifying by geography, product type and channel; maintaining our commitment to quality; cultivating our corporate cultureand workforce; and continuing to manage for the long-term.Acquisitions, including that of Matrix Laboratories Limited (2007); Merck KGaA’s generics and specialty pharmaceutical business (2007); the EPDBusiness (as defined below) (2015) and Meda AB (publ.) (“Meda”) (2016), have played a significant role in our transformation. We continue to acquirecomplementary products and product-development capabilities. As part of our acquisition-integration efforts, Mylan has focused on how to best optimizeand maximize all of our assets across the organization and all geographies.Mylan N.V. was originally incorporated as a private limited liability company in the Netherlands in 2014. Mylan became a public limited liabilitycompany in the Netherlands through its acquisition of Abbott Laboratories’ non-U.S. developed markets specialty and branded generics (“Bx”) business (the“EPD Business”) on February 27, 2015. Mylan’s corporate seat is in the Netherlands; our principal executive offices are in England and our group’s globalheadquarters is in the U.S.Unless otherwise indicated, industry data included in Item 1 is sourced from IQVIA Holdings Inc. and is for the twelve months ended November2018. Mylan product information is from internal sources and is as of December 31, 2018.3Table of ContentsBusiness Model and OperationsOur mission is grounded in our conviction that every person should have the opportunity to live the healthiest life possible. For this reason,providing access to medicine is an important goal of our business model, pictured below.OUR BUSINESS MODELTo provide access, we seek to satisfy the needs of an incredibly diverse global pharmaceutical marketplace whose economic and political systems,approaches to delivering and paying for healthcare, languages and traditions, and customer and patient requirements vary by location and over time.It is with these considerations in mind that we built and scaled our commercial, operational and scientific platforms, which we believe meet theevolving needs of customers in ways that are globally consistent and locally sensitive. As a result, Mylan now reaches patients with a wide range of products.We believe that the breadth and depth - i.e., the diversity - of our business and platforms have rendered our business durable, as we are not dependenton any single market or product.4Table of ContentsWe also believe that durability not only helps us expand people’s access to medicine, it also allows us to better compete on a global basis than manyof our peers. Our primary competitors in the prescription drugs space include other pharmaceutical companies, including manufacturers of brand-name,generic drug and branded drug companies that continue to sell or license branded pharmaceutical products after patent expirations and other statutoryexpirations. Our OTC products face competition from pharmaceutical companies and from retailers that carry their own private-label brands.DURABILITY COMPONENTSWe have structured our business and strive to operate it in ways that maximize our operational and financial results. Operationally, for instance, wehave chosen to vertically integrate much of our manufacturing activity; this means producing many of our own active pharmaceutical ingredients (“APIs”)and finished dosage forms. This approach affords us greater control over the cost and quality of what we make. All of the facilities discussed below areincluded in our reportable segments (North America, Europe, and Rest of World) primarily based on the location of the facility.Our principal administrative, research and development (“R&D”) and manufacturing facilities are located around the world; many of the latter arestrategically located in proximity to key markets.In the U.S. and Puerto Rico, we own 16 manufacturing, distribution, and administrative facilities. Principal facilities include the group’s globalheadquarters in Canonsburg, Pennsylvania; our campus in Morgantown, West Virginia, which includes an R&D center of excellence and manufacturingplant; and our distribution center in Greensboro, North Carolina.Outside the U.S. and Puerto Rico, we own 39 production, distribution, and administrative facilities in 15 countries.In Europe, principal facilities include our principal executive offices in Hatfield, Hertfordshire, England; our global center in Dublin, Ireland; as wellas key facilities in Ireland, Hungary, and France.We also operate key facilities in India, Australia, and Japan. In India, principal facilities include our global center in Bangalore; an R&D center ofexcellence in Hyderabad; and several manufacturing plants located throughout the country.Mylan also leases manufacturing, warehousing, distribution and administrative facilities in various locations, both within and outside of the U.S.Finally, Mylan relies upon many of our collaboration partners’ manufacturing and other facilities throughout the world.We believe all our facilities are in good operating condition, the machinery and equipment are well-maintained, the facilities are suitable for theirintended purposes and they have capacities adequate for the current operations.5Table of ContentsThe APIs and other materials and supplies we use in our manufacturing operations are purchased from third parties, and some are producedinternally. Occasionally, however, resources we need are available from only a single supplier. Like many pharmaceutical companies, we supplement ourproduction footprint through arrangements with other manufacturers.Facilities and records related to our products are subject to periodic inspection by the U.S. Food and Drug Administration (the “FDA”), the EuropeanMedicines Agency (“EMA”), the Therapeutic Goods Administration in Australia and other authorities, as applicable. In addition, authorities often conductpre-approval plant inspections to determine whether our systems and processes comply with current Good Manufacturing Practices (“cGMP”) and otherregulations, and clinical-trial reviews to evaluate regulatory compliance and data integrity. Our suppliers, contract manufacturers, clinical trial partners andother business partners are subject to similar regulations and periodic inspections.Moreover, as a part of our commitment to caring for the environment, we strive to comply in all material respects with applicable environmental lawsand regulations. While it is impossible to predict accurately the future costs associated with environmental compliance and potential remediation activities,compliance with environmental laws is not expected to require significant capital expenditures and has not had, and is not expected to have, a materialadverse effect on our operations or competitive position.Customers and MarketingOur customers are essential in helping us create better health for a better world by making our products available to patients. Numbering in the tensof thousands, our customers include retail pharmacies; wholesalers and distributors; payers, insurers and governments; and institutions such as hospitals;among others. See “Channel Types” below for more information about our customers.The table below displays the percentage of consolidated net sales to our largest customers during the years ended December 31, 2018, 2017 and2016. Percentage of Consolidated Net Sales 2018 2017 2016McKesson Corporation12% 13% 16%AmerisourceBergen Corporation8% 8% 14%Cardinal Health, Inc.8% 10% 11%In addition to being dynamic, the pharmaceutical industry is complex. How it functions, how it is regulated and how it provides patients accessvaries by location. Similarly, competition is affected by many factors. Examples of factors include innovation and development, timely approval ofprescription drugs by health authorities, manufacturing capabilities, product quality, marketing effectiveness, portfolio size, customer service, consumeracceptance, product price, political stability and the availability of funding for healthcare.Certain parts of our business also are affected by seasonality, e.g., due to the timing and severity of peak cough, cold and flu incidence, which cancause variability in sales trends for some of our products. While seasonality may affect quarterly comparisons within a fiscal year; it generally is not materialto our annual consolidated results.We serve our customers through a team of more than 7,000 sales and marketing professionals, all of whom are focused on establishing Mylan as ourcustomers’ partner of choice. To best meet customers’ needs, Mylan manages its business on a geographic basis.For these and other reasons, Mylan’s sales and marketing efforts vary accordingly by product, market and channel type, each of which is describedbelow.See the Application of Critical Accounting Policies section in Item 7 for more information related to customer arrangements.6Table of ContentsProduct TypesMylan markets prescription brand-name drugs; unbranded and branded prescription generic drugs; OTC products and APIs.Brand-name drugs (“Rx”) typically are prescription pharmaceuticals that are sufficiently novel as to be protected by patents or other forms ofexclusivity. As such, these drugs, which bear trade names, may be produced and sold only by those owning the rights, subject to certain challenges that othercompanies may make. Developing new medicines can take years and significant investment. Only a few promising therapies ever enter clinical trials. Fewerstill are approved for sale by health authorities, at which point marketing to healthcare providers and consumers begins.Because patents and exclusivities last many years, they serve as an incentive to developers. During the periods protected, developers often recouptheir investments and earn a profit. In many high-income countries, the brand business often is characterized by higher margins on lower volumes - especiallyas compared with generic manufacturers. We have acquired most of the branded products we offer.Generic drugs are therapeutically equivalent versions of brand-name medicines. Generics generally become available once the patents and otherexclusivities on their branded counterparts expire. Gx products typically are sold under their International Nonproprietary Names (“INNs”). INNs facilitatethe identification of pharmaceutical substances or APIs. Each INN is unique and globally recognized. A nonproprietary name also is known as a genericname.Mylan, like many other generic drugmakers, invests significant sums in R&D and in manufacturing capacity. We also often incur substantiallitigation expense as a result of challenging brand patents or exclusivities. But because generic drugmakers are not required to reproduce expensive clinicaltrials and seldom engage in product promotion, Gx typically cost far less than branded drugs. The generics business is generally characterized by lowermargins on higher volumes, as most generic drugmakers, Mylan included, offer a relatively large number of products.Branded generics are off-patent products that are sold under an approved proprietary name for marketing purposes. Rx products often become Bxproducts once patent protections or other forms of exclusivity expire. Bx products are common in many countries outside the U.S., including emergingmarkets. In addition, complex products, such as biosimilars (that is, a biological product that is highly similar to an already approved reference biologicalproduct, and for which there are no7Table of Contentsclinically meaningful differences between the biosimilar and the reference biological product in terms of safety, purity and potency), often are marketedunder a brand-name.Rx and Bx products are more sensitive to promotion than are unbranded generic products. They therefore represent the focus of most of our salesrepresentatives and product-level marketing activity.OTC products are sold directly to consumers, without a prescription and without reimbursement. As with prescription medicines, properly approvedOTC products are proven to be safe and effective when used as directed. OTC products also are subject to various regulatory requirements, including thoseapplicable to manufacturing, advertising and promotion. OTC products may be sold under a brand-name or a molecule name.Our API is sold through a dedicated sales and marketing team primarily to pharmaceutical companies throughout the world.Market TypesLike other drug companies, Mylan focuses its sales and marketing efforts on the people who make key decisions around pharmaceutical prescribing,dispensing or buying. Decision-makers vary by country or region, reflecting law and custom, giving rise to different types of pharmaceutical markets. Manycountries feature a mix of or hybrids of various market types, though Mylan may focus on just one type.In prescription markets, physicians decide which medicines patients will take. Pharmacies then dispense the products as directed. Drug companiesemploy sales forces to educate doctors about the clinical benefits of their products. Representatives call on individual doctors or group practices; the processis known as detailing. Examples of countries served by Mylan that are mainly prescription markets are Japan, China, Russia, Turkey, Poland and Mexico.In substitution markets, pharmacists generally are authorized (and in some cases required) by law to dispense an unbranded or branded generic, ifavailable, in place of a brand-name medicine, or vice versa. Drug companies may use sales forces in these markets too, with representatives calling on andeducating pharmacy personnel about their organization and products. Examples of countries served by Mylan that are mainly substitution markets areFrance, Italy, Spain, Portugal and Australia.In tender markets, payers, such as governments or insurance companies, negotiate the lowest price for a drug (or group of drugs) on behalf of theirconstituents or members. In exchange, the chosen supplier’s product is placed on the payer’s formulary, or list of covered prescriptions. Often, a supplier’sdrug is the only one available in an entire class of drugs. Large sales forces are not needed to reach these decision-makers. Examples of generic marketsserved by Mylan that are mainly tender markets are Germany, New Zealand, Sweden and Denmark.In distribution markets, retailers and wholesalers make drug-purchasing decisions. Large sales forces are not needed to reach the decision-makersrepresenting these organizations. Note, however, that pharmacists operating in distribution markets also may be authorized to make substitution decisionswhen dispensing medicines. Examples of countries served by Mylan that are mainly distribution markets are the U.S., the United Kingdom (“U.K.”) andNorway.The allocation of our sales and marketing resources reflects the characteristics of these different market types.In the case of OTC products, consumers are the decision-makers. OTC products are commonly sold via retail channels, such as pharmacies,drugstores and supermarkets. This makes their sale and marketing comparable to other retail businesses, with broad advertising and trade-channel promotion.Consumers often are loyal to well-known OTC brands. For this reason, suppliers of OTC products, Mylan included, must invest the time and resources neededto build strong OTC brand names.Channel TypesMylan’s products make their way to patients through a variety of intermediaries, or channels.Pharmaceutical wholesalers/distributors purchase prescription medicines and other medical products directly from manufacturers for storage inwarehouses and distribution centers. The distributors then fill orders placed by healthcare providers and other authorized buyers.8Table of ContentsPharmaceutical retailers purchase products directly from manufacturers or wholesalers/distributors. They then sell them to consumers in relativelysmall quantities for personal use.Institutional pharmacies address the unique needs of hospitals, nursing homes and other such venues. Among the services provided are specializedpackaging, such as unit-dose supply, for controlled administration.Mail-order and e-commerce pharmacies receive prescriptions by mail, fax, phone or the internet at a central location; process them in large, mostlyautomated centers; and mail the drugs to the consumer.Specialty pharmacies focus on managing the handling and service requirements associated with high-cost and more-complex drug therapies, such asthose used to treat patients with rare or serious diseases.Business SegmentsConsistent with Mylan’s focus on bringing its broad and diversified portfolio products to people in markets everywhere, the company reports resultsin three segments on a geographic basis as follows: North America, Europe and Rest of World.Our North America segment comprises our operations in the U.S. and Canada. Our Europe segment encompasses our operations across 35 countries,including France, Italy, Germany, the U.K. and Spain. Our Rest of World segment reflects our operations in more than 120 countries outside of our NorthAmerica and Europe segments.The charts below display Mylan’s net sales by segment and by product type for the year ended December 31, 2018. Net sales are generated primarilyfrom the sale of pharmaceutical products, including API. With respect to product type, generic offerings continue to represent 57% of our net sales, in keeping with Mylan’s emphasis on expanding people’saccess to medicine.9Table of ContentsIn addition, we have focused our products in 10 major therapeutic areas. We have critical mass in these areas, though our sales emphasis varies bymarket according to need and opportunity.MYLAN’S MAJOR THERAPEUTIC AREAS* ProductsCardiovascularCNS & AnesthesiaDermatologyDiabetes & MetabolismGastroenterologyCurrent1,1501,900500450700Pipeline32055060300150 ProductsImmunologyInfectious DiseaseOncologyRespiratory & AllergyWomen’s HealthCurrent801,100450600650Pipeline100900550150150 *Product defined by product/dosage form/country. Products taken from internal data and rounded.North AmericaMylan’s business in North America is driven mainly by our operations in the U.S., where we are one of the largest providers of prescriptionmedicines. The U.S. pharmaceutical industry is very competitive, and the primary means of competition are innovation and development, timely FDAapproval, manufacturing capabilities, product quality, marketing, portfolio size, customer service, reputation and price. We rely on cost-effectivemanufacturing processes to meet the rapidly changing needs of our customers around a reliable, high quality supply of generic pharmaceutical products.Gx are widely accepted in the U.S., accounting in 2018 for approximately 90% of prescriptions dispensed, but only about 20% of total prescriptiondrug costs. Over the last five years, Mylan has launched more generics in the U.S. than any other company.Among our branded prescription products are EpiPen® Auto-Injector, Perforomist® Inhalation Solution and Dymista®. Also, we launchedYUPELRITM, an inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease, in December 2018. Our OTCportfolio includes Cold-EEZE®, MidNite® and Vivarin®, as well as other products. Our promotion efforts are supported by a salesforce of approximately400 sales representatives.10Table of ContentsNew product launches are an important growth driver. Important recent launches include complex products such as Wixela™ Inhub™ (genericAdvair Diskus®) in February 2019, Glatiramer Acetate Injection (generic Copaxone®), Fulphila™ (biosimilar to Neulasta®) and generic ESTRACE®. Ouremphasis on complex products, some of which we develop in collaboration with other companies, is evidenced by, to name a few of relevance in the U.S., ourefforts to introduce generic versions of Symbicort®, Restasis®, EYLEA® and the biosimilar to Herceptin®.While our U.S. customer base is extensive, it increasingly comprises a small number of very large firms, as the pharmaceutical industry continues toundergo tremendous change and consolidation. Mylan is well positioned to serve such customers - in the U.S. and elsewhere - due to the scale we have builtin terms of R&D, API and finished-dosage-form manufacturing, and portfolio breadth.EuropeMylan’s business in Europe is driven by our scale across 35 countries.Generic medicines have transformed healthcare in the region over the last decade by significantly increasing patients’ access to medicine in an era ofrising demand for healthcare services and constrained finances. In 2018 generic pharmaceuticals represented more than half of medicines used in Europe, butless than one quarter of total drug costs. Europe represents the world’s second largest generic pharmaceuticals market, by value. The European markets, wheremany governments provide healthcare at a low direct cost to consumers and regulate pharmaceutical prices or patient reimbursement levels, continue to behighly competitive, especially in terms of pricing, quality standards, service levels and product portfolio. Our leadership position in a number of countriesprovides us a platform to fulfill the needs of patients, physicians, pharmacies, customers and payors.Among our many branded prescription products are Creon®, Influvac® and Dymista®. Our OTC portfolio includes Brufen®, CB12® andEndWarts®, as well as other products. Our promotional efforts in the region are supported by approximately 2,500 sales representatives.New product launches are an important growth driver. Our focus on complex products is evidenced by our ability to gain approval for products suchas HulioTM (adalimumab), Glatiramer Acetate, Semglee™, our insulin glargine, and OgivriTM (trastuzumab-dkst). In addition we remain focused onintroducing additional biosimilars like Fulphila™ (pegfilgrastim) and rituximab.We expect Mylan’s business in Europe to keep benefiting from our commercial platform, through which we simultaneously can serve multiplemarket types through multiple channels. Doing so allows us to focus on maximizing returns on investment by, for instance, repurposing branded drugs thatlose exclusivity as tender or substitution products, or by switching from one proven strategy to another as individual government policies evolve, as iscurrently the case for biosimilars.We look to maintain our leadership positions in markets such as France and Italy and prioritize opportunities in additional markets, such asGermany, Spain and the U.K.11Table of ContentsRest of WorldMylan’s commercial operations in Rest of World comprise a diverse group of businesses, many of which we believe have high growth potential. TheRest of World markets are attractive because of the growing middle class within these countries combined with an increase in the demand for pharmaceuticalproducts. The highly competitive environment includes conditions like pricing and market access challenges, potential political instability, significantcurrency fluctuations and limited or changing availability of funding for healthcare.Mylan’s focus on becoming a leader in supplying antiretroviral medicines (“ARVs”) to treat HIV/AIDS has helped to increase our presence in manyemerging market countries over the last decade.Today approximately 40% of people being treated worldwide for the disease, as well as approximately 60% of the world’s HIV+ children, rely onone of our products. Most of these individuals live in countries that make up our Rest of World segment.Many countries in this segment are brand-focused, and generic penetration is low. Our more than 2,000 sales representatives are deployed inapproximately 35 countries to promote our products. Among them are brands such as Amitiza®, Dona®, Creon®, Elidel® and Legalon®.New product launches are an important growth driver. In accordance with our focus on complex products, we look forward to continuing to launchproducts such as Semglee™, ABEVMY® (bevacizumab) and OgivriTM (trastuzumab-dkst) into additional countries, and introducing new medicines.We look to maintain our leadership positions in countries such as Australia and Japan. We also are focused on maximizing opportunities inemerging markets like China, Brazil, India, Russia, Mexico, Turkey and Southeast Asia, where we see opportunity to introduce our existing global portfolioof products, especially our generics.In addition, we have begun leveraging our ARV platform and expertise to help HIV patients in higher-income countries, and to expand access totreatments for other infectious diseases, such as tuberculosis and malaria.Refer to Note 14 Segment Information included in Item 8 in this Annual Report on Form 10-K for more information about our segments.Government RegulationRegulation by governmental authorities is a significant factor in the R&D, manufacture, marketing, sales and distribution of pharmaceuticals.Human therapeutic products are subject to rigorous preclinical and clinical testing to gather data to support approval, which requires extensive data andinformation; manufacturing is conducted under exacting conditions governed by extensive regulation; and post-approval activities, such as advertising andpromotion and pharmacovigilance, are subject to pervasive regulation.The lengthy process of developing products and obtaining required approvals and the continuing need for post-approval compliance withapplicable statutes and regulations, require the expenditure of substantial resources. Regulatory12Table of Contentsapproval, if and when obtained, may be limited in scope. Further, approved drugs, as well as their manufacturers, are subject to ongoing post-marketingreview and inspection, which can lead to the discovery of previously unknown problems with products or the manufacturing or quality control proceduresused in their production, which may result in restrictions on their manufacture, sale or use or in their withdrawal from the market.Any failure or delay by us, our suppliers of manufactured drug product, collaborators or licensees, in obtaining regulatory approvals could adverselyaffect the marketing of our products and our ability to receive product revenue, license revenue or profit-sharing payments.Other Regulatory RequirementsOur business is subject to a wide range of various other federal, state, non-governmental, and local agency rules and regulations. They focus on fraudand corruption, pricing and reimbursement, data privacy, and the environment, among many other considerations. For more information about certain ofthese regulations and the associated risks we face, see Item 1A. Risk Factors.Research and DevelopmentMylan has a globally integrated R&D platform that is fueling our growth by filling our pipeline. We believe R&D always has been one of Mylan’score strengths. Our Scientific Affairs team, which includes researchers and regulatory and clinical experts, numbers more than 3,000 people who workcollaboratively across our 12 different R&D centers around the world, including 10 technology-focused development sites and 2 global R&D centers.Consistent with Mylan’s drive for durability, the allocation of our investments over the last several years has shifted away from commodity products,such as conventional oral solid dosage (“OSD”) forms, to more complex or difficult-to-formulate products, such as biosimilars.13Table of ContentsAs a result, our product pipeline includes a variety of dosage forms. Collectively, these investments represent more than 3,600 products underdevelopment or pending approval around the world. Refer to the chart in the Business Segments section above for information pertaining to products inpipeline by major therapeutic area.Collaboration and Licensing AgreementsWe periodically enter into collaboration and licensing agreements with other companies to develop, manufacture, market and/or sell pharmaceuticalproducts. Doing so helps us share risks and costs, leverage strengths and scale up commercialization. The result often is that medicines become availablesooner and to a significantly larger group of patients.Our significant agreements are primarily focused on the development, manufacture, supply and commercialization of multiple, high-value biosimilarcompounds, insulin analog products and respiratory products. Mylan’s significant collaboration and licensing agreements include those with Pfizer Inc.(“Pfizer”), Momenta Pharmaceuticals, Inc. (“Momenta”), Theravance Biopharma, Inc. (“Theravance Biopharma”), Biocon Ltd. (“Biocon”) and FujifilmKyowa Kirin Biologics Co. Ltd. Refer to Note 18 Collaboration and Licensing Agreements included in Item 8 in this Annual Report on Form 10-K for moreinformation.Intellectual PropertyMylan considers the protection of our intellectual property rights to be extremely valuable, and we act to protect them from infringement by thirdparties.We have an extensive trademark portfolio and routinely apply to register key brand-name, generic, branded generic, biosimilars and OTC tradenames in numerous countries around the world. Our registered trademarks are renewable indefinitely, and these registrations are properly maintained inaccordance with the laws of the countries in which they are registered.We also have an extensive patent portfolio and actively file for patent protection in various countries to protect our brand-name, generic, brandedgeneric, biosimilars and OTC products, including processes for making and using them. We have more than 4,500 patents filed globally. For additionalinformation, see “Risk Factors - We rely on the effectiveness of our patents, confidentiality agreements and other measures to protect our intellectualproperty rights.”Further, we have well-established safeguards in place to protect our proprietary know-how and trade secrets, both of which we consider extremelyvaluable to our intellectual property portfolio.We look for intellectual property licensing opportunities to or from third parties, related not only to our existing products, but as a means forexpanding our product portfolio.We rely on the aforementioned types of intellectual property, as well as our copyrights, regulatory exclusivities and contractual protections, toestablish a broad scope of intellectual property rights for our product portfolio.Exchange Act ReportsMylan maintains a website at Mylan.com. We make available on or through it certain reports and associated amendments that the Company fileswith the Securities and Exchange Commission (“SEC”) in accordance with the Securities Exchange Act of 1934 (“Exchange Act”). Filings include ourannual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports.We make this information available on our website free of charge, as soon as reasonably practicable after we electronically file such material with, orfurnish it to, the SEC. The contents of our website are not incorporated by reference in this Annual Report on Form 10-K and shall not be deemed “filed”under the Exchange Act.The SEC also maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuersthat file electronically with the SEC.ITEM 1A.Risk FactorsWe operate in a complex and rapidly changing environment that involves risks, many of which are beyond our control. Our business, financialcondition, results of operations, cash flows, and/or share price could be materially affected by any of these14Table of Contentsrisks, if they occur, or by other factors not currently known to us, or not currently considered to be material. These risk factors should be read in conjunctionwith the other information in this Annual Report on Form 10-K, as well as our other filings with the SEC.Our risk factors are organized into four categories: Strategic, Operational, Compliance and Finance.Strategic RisksWe do not anticipate paying dividends for the foreseeable future, and our shareholders must rely on increases in the trading price of our ordinary shares toobtain a return on their investment.Mylan N.V. does not anticipate paying dividends in the immediate future. We anticipate that we will retain all earnings, if any, to support ouroperations and to opportunistically pursue additional transactions to deliver additional shareholder value. Any future determination as to the payment ofdividends will, subject to Dutch law requirements, be at the sole discretion of our board of directors and will depend on our financial position, results ofoperations, capital requirements, and other factors our board of directors deems relevant at that time. Holders of Mylan N.V.’s ordinary shares must rely onincreases in the trading price of their shares to obtain a return on their investment in the foreseeable future.The market price of our ordinary shares may be volatile, and the value of your investment could materially decline.Investors who hold Mylan N.V.’s ordinary shares may not be able to sell their shares at or above the price at which they purchased such shares. Theshare price of Mylan N.V.’s ordinary shares fluctuates materially from time to time, including a significant decline throughout 2018, and we cannot predictthe price of our ordinary shares at any given time. The risks described herein could cause the price of our ordinary shares to fluctuate materially. In addition,the stock market in general, including the market for pharmaceutical companies, has experienced price and volume fluctuations. These broad market andindustry factors may materially harm the market price of our ordinary shares, regardless of our operating performance. In addition, the price of our ordinaryshares may be affected by the valuations and recommendations of the analysts who cover us, and if our results do not meet the analysts’ forecasts andexpectations, the price of our ordinary shares could decline as a result of analysts lowering their valuations and recommendations or otherwise. In the past,following periods of volatility in the market and/or in the price of a company’s stock, securities class-action litigation has been instituted against us andother companies. Such litigation could result in substantial costs and diversion of management’s attention and resources, which could have a materialadverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price. We or our shareholders also may offer or sellour ordinary shares or securities convertible into or exchangeable or exercisable for ordinary shares. An increase in the number of ordinary shares issued andoutstanding and the possibility of sales of ordinary shares or securities convertible into or exchangeable or exercisable for ordinary shares may depress thefuture trading price of our ordinary shares. In addition, if additional offerings occur, the voting power of our then existing shareholders may be diluted.Our strategic initiatives may not achieve all intended benefits.There can be no assurance that our strategic initiatives will achieve their intended effects. We continually evaluate various strategic transactions andbusiness arrangements, including acquisitions, asset purchases, partnerships, joint ventures, restructurings, divestitures, investments, market selection andmarket strategy on an ongoing basis. These transactions and arrangements may be material both from a strategic and financial perspective. There can be noassurance that we will be able to successfully complete the integration of acquired businesses or assets with Mylan, or otherwise fully realize the expectedbenefits of any transactions or restructurings. Furthermore, although our expectation is to engage in asset sales only if they advance or otherwise support ouroverall strategy, any such sale could reduce the size or scope of our business, our market share in particular markets or our opportunities with respect tocertain markets, products or therapeutic categories. The difficulties of achieving the benefits of strategic initiatives include, among others:•the diversion of management’s attention to integration matters and restructuring activities;•difficulties in achieving anticipated synergies, operating efficiencies, business opportunities, and growth prospects from restructurings or business orasset combinations within the expected timeframe or at all;•difficulties in the integration of operations and information technology (“IT”) applications, including enterprise resource planning (“ERP”) systems;•difficulties in the integration of employees;•difficulties in managing the operations of a larger or more complex company;15Table of Contents•challenges in keeping existing customers and obtaining new customers;•challenges in reducing reliance on transition services prior to the expiration of any period in which such services are provided by a transactioncounterparty;•difficulties in obtaining a favorable price for any divestiture, in a timely manner or at all;•challenges in moving production facilities, including obtaining the consent of customers or regulatory authorities;•operational or financial difficulties that would not have occurred if acquired companies, businesses, or assets continued operating in their formerstructures;•challenges in attracting and retaining key personnel; and•the complexities of managing relationships with transaction counterparties and other business partners, including service agreements, developmentand manufacturing relationships, and license arrangements.The overall execution of a strategic initiative, including the integration of a business or asset or restructuring activities, may result in materialunanticipated problems, expenses, liabilities, competitive responses, loss of customer relationships, and diversion of management’s attention, among otherpotential adverse consequences, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/orordinary share price.We may be adversely affected by significant scrutiny from third parties, including governments, or negative publicity with respect to matters relating to ourproducts, pricing practices and other matters.The Company has been subject to significant press coverage and scrutiny from third parties, including regulators, legislative bodies andenforcement agencies, with respect to matters relating to our business, pricing practices, and other matters. This coverage and public scrutiny have includedassertions of wrongdoing against the Company which, regardless of the factual or legal basis for such assertions, have resulted in, and may continue to resultin, investigations, and calls for investigations, by governmental agencies at both the federal and state levels, claims brought against the Company bygovernmental agencies or private parties, and regulators taking other measures that could have a negative effect on the Company’s business. For example,both the U.S. House of Representatives and the U.S. Senate have conducted hearings with respect to pharmaceutical drug pricing practices and alleged anti-competitive behavior by pharmaceutical companies, and additional hearings are scheduled. Ongoing focus on these issues has in the past led and in thefuture could lead to investigations of price increases and other business practices of specific pharmaceutical companies, including Mylan. It is not possible topredict the ultimate outcome of any such investigations or claims or what other investigations or lawsuits or regulatory responses may result from suchassertions.There has also recently been intense publicity regarding the pricing of pharmaceuticals more generally, including publicity and pressure resultingfrom prices charged by competitors and peer companies for new products as well as price increases by competitors and peer companies on older products thatsome have deemed excessive. We have experienced and may continue to experience downward pricing pressure on the price of certain of our products due tosocial or political pressure to lower the cost of drugs, which could reduce our revenue and future profitability.Any of the above developments could result in reputational harm and reduced market acceptance and demand for our products, could harm ourability to market our products in the future, could cause us to incur significant expense, could cause our senior management to be distracted from executionof our business strategy, and could have a material adverse effect on our business, reputation, financial condition, results of operations, cash flows and/orordinary share price.We have and may continue to experience pressure on the pricing of and reimbursements for certain of our products due to consolidation among purchasersor social and political pressure to lower the cost of drugs.We operate in a challenging environment, with significant pressures on the pricing of our products and on our ability to obtain and maintainsatisfactory rates of reimbursement for our products by governments, insurers and other payors. The growth of overall healthcare costs has led governmentsand payors to implement new measures to control healthcare spending. As a result, we face numerous cost-containment measures by governments and otherpayors, including certain government-imposed industry-wide price reductions, mandatory pricing systems, reference pricing systems, tender systems, shiftingof the payment burden to patients through higher co-payments, and requirements for increased transparency on pricing. In the U.S., certain of these pressuresare further compounded by increasing consolidation among wholesalers, retailer drug chains, pharmacy benefit managers (“PBMs”), private insurers,managed care organizations and other private payors, which can increase their negotiating power, particularly with respect to our generic drugs. Please alsorefer to “A significant portion of our revenues is derived from sales to a limited number of customers.”16Table of ContentsThere has also been increasing U.S. federal and state legislative and enforcement interest with respect to drug pricing. In particular, U.S. federalprosecutors have issued subpoenas to pharmaceutical companies, including Mylan, seeking information about their drug pricing practices, among otherissues, and members of the Congress have sought information from certain pharmaceutical companies, including Mylan, relating to drug-price increases.In addition, there has been legislation and legislative proposals concerning drug prices and related issues, including the perceived need to bringmore transparency to drug pricing, reviewing the relationship between pricing and manufacturer patient programs, and reforming government programreimbursement methodologies for drugs. For example, California, Oregon and several other states have recently implemented legislation requiringpharmaceutical companies to provide greater transparency with respect to drug prices and price increases and other states are considering similar legislation.This type of legislation, at the federal or state level, could affect demand for, or pricing of, our products and we cannot predict what, if any, additionallegislative developments may transpire or what the ultimate impact may be.Any of the events or developments described above could have a material adverse impact on our business, reputation, financial condition, results ofoperations, cash flows and/or ordinary share price.Current and changing economic conditions may adversely affect our industry, business, partners and suppliers.The global economy continues to experience significant volatility, and the economic environment may become less favorable. Economic volatility,governmental financial restructuring efforts and evolving deficit and spending reduction programs could negatively impact the global economy and thepharmaceutical industry. This has led, or could lead, to reduced consumer and customer spending, reduced or eliminated governmental or third-party payorcoverage or reimbursement or reduced spending on healthcare, including but not limited to pharmaceutical products. While generic drugs present analternative to higher-priced branded products, our sales could be negatively impacted if patients forego obtaining healthcare, patients and customers reducespending or purchases, or if governments or third-party payors reduce or eliminate coverage or reimbursement amounts for pharmaceuticals or impose price orother controls adversely impacting the price or availability of pharmaceuticals. In addition, reduced consumer and customer spending, reduced governmentor third-party payor coverage or reimbursement, or new government controls, may drive us and our competitors to decrease prices, may reduce the ability ofcustomers to pay, or may result in reduced demand for our products. The occurrence of any of these risks could have a material adverse effect on our industry,business, financial condition, results of operations, cash flows, and/or ordinary share price.We have significant operations globally, which exposes us to the risks inherent in conducting our business internationally.Our operations extend to numerous countries outside the U.S., including our significant operations in India, and are subject to the risks inherent inconducting business globally and under the laws, regulations, and customs of various jurisdictions. These risks include, but are not limited to:•compliance with the national and local laws of countries in which we do business, including, but not limited to, data privacy and protection,import/export and intellectual property protections;•less established legal and regulatory regimes in certain jurisdictions;•compliance with a variety of U.S. laws including, but not limited to, regulations put forth by the U.S. Treasury’s Office of Foreign Assets Control, theIran Threat Reduction and Syria Human Rights Act of 2012 and rules relating to the use of certain “conflict minerals” under Section 1502 of theDodd-Frank Wall Street Reform and the Consumer Protection Act;•changes in laws, regulations, and practices affecting the pharmaceutical industry and the healthcare system, including but not limited to imports,exports, manufacturing, quality, cost, pricing, reimbursement, approval, inspection, and delivery of healthcare;•changes in policies designed to promote foreign investment, including significant tax incentives, liberalized import and export duties, andpreferential rules on foreign investment and repatriation;•differing local product preferences and product requirements;•adverse changes in the economies in which we or our partners and suppliers operate as a result of a slowdown in overall growth, a change ingovernment or economic policies, or financial, political, or social change or instability in such countries that affects the markets in which weoperate, particularly emerging markets;•changes in employment laws, wage increases, or rising inflation in the countries in which we or our partners and suppliers operate;•supply disruptions and increases in energy and transportation costs;17Table of Contents•increased tariffs on the import or export of our products or API, including on imports from China to the U.S.;•natural or man-made disasters, including droughts, floods, earthquakes, hurricanes and the impact of climate change in the countries in which we orour partners and suppliers operate;•local disturbances, terrorist attacks, riots, social disruption, wars, or regional hostilities in the countries in which we or our partners and suppliersoperate and that could affect the economy, our operations and employees by disrupting operations and communications, making travel and theconduct of our business more difficult, and/or causing our customers to be concerned about our ability to meet their needs; and•government uncertainty, including as a result of new or changed laws and regulations.We also face the risk that some of our competitors have more experience with operations in such countries or with international operations generallyand may be able to manage unexpected crises more easily. Moreover, the internal political stability of, or the relationship between, any country or countrieswhere we conduct business operations may deteriorate. Changes in a country’s political stability or the state of relations between any such countries aredifficult to predict and the political or social stability in and/or diplomatic relations between any countries in which we or our partners and suppliers dobusiness could meaningfully deteriorate.For example, the formal change in the relationship between the European Union (“EU”) and the U.K. as a result of the U.K. referendum to leave theEU (“Brexit”) could impact our business. Whether Brexit occurs, as well as its exact structure and timing, are still being negotiated and therefore the impactremains uncertain. However, in the event Brexit occurs, it could lead to divergent national laws and regulations, import/export restrictions, and potentialchanges to intellectual property rights, regulatory approval requirements and pharmaceutical regulations in the EU and the U.K., which could materiallyimpact the way we conduct our operations in those markets. In addition, because we are tax resident in the U.K., the U.K. withdrawal from the EU could,depending on the results of the ongoing negotiations, eliminate the benefit of certain tax treaties and tax-related EU directives, which could have a materialadverse effect on our tax position by, among other effects, subjecting us to withholding taxes on certain intercompany transactions. It may be time-consuming and expensive for us to alter our internal operations in order to comply with such new or changing regulations or tax treatments. Any of theseeffects of Brexit, and others we cannot anticipate, could negatively affect our business and financial results.The occurrence of any one or more of the above risks could have a material adverse effect on our business, financial condition, results of operations,cash flows, and/or ordinary share price.Charges to earnings resulting from acquisitions could have a material adverse effect on our business, financial condition, results of operations, cash flowsand/or ordinary share price.Under accounting principles generally accepted in the U.S. (“U.S. GAAP”) relating to business acquisition accounting standards, we recognize theidentifiable assets acquired, the liabilities assumed, and any noncontrolling interests in acquired companies generally at their acquisition date fair valuesand, in each case, separately from goodwill. Goodwill as of the acquisition date is measured as the excess amount of consideration transferred, which is alsogenerally measured at fair value, and the net of the acquisition date amounts of the identifiable assets acquired and the liabilities assumed. Our estimates offair value are based upon assumptions believed to be reasonable, but which are inherently uncertain. After we complete an acquisition, the following factorscould result in material charges and adversely affect our operating results and may adversely affect our cash flows:•costs incurred to combine the operations of companies we acquire, such as transitional employee expenses and employee retention, redeployment orrelocation expenses;•impairment of goodwill or intangible assets, including acquired in-process research and development (“IPR&D”);•amortization of intangible assets acquired;•a reduction in the useful lives of intangible assets acquired;•identification of or changes to assumed contingent liabilities, including, but not limited to, contingent purchase price consideration including fairvalue adjustments, income tax contingencies and other non-income tax contingencies, after our final determination of the amounts for thesecontingencies or the conclusion of the measurement period (generally up to one year from the acquisition date), whichever comes first;•charges to our operating results to eliminate certain duplicative pre-acquisition activities, to restructure our operations or to reduce our coststructure; and•charges to our operating results resulting from expenses incurred to effect the acquisition.18Table of ContentsA significant portion of these adjustments could be accounted for as expenses that will decrease our net income and earnings per share for theperiods in which those costs are incurred.In particular, the amount of goodwill and identifiable intangible assets on our consolidated balance sheets is significant as a result of ouracquisitions and other transactions, and may increase further following future potential acquisitions, and we may, from time to time, sell assets that wedetermine are not critical to our strategy or execution. Future events or decisions may also lead to asset impairments and/or related charges. Certain non-cashimpairments may result from a change in our strategic goals, business direction or other factors relating to the overall business environment.Any such charges could cause a material adverse effect on our business, financial condition, results of operations, cash flows, shareholders’ equityand/or ordinary share price.The illegal distribution and sale by third parties of counterfeit versions of our products or of diverted or stolen products could have a negative impact onour reputation and our business.The pharmaceutical drug supply has been increasingly challenged by the vulnerability of distribution channels to illegal counterfeiting and thepresence of counterfeit products in a growing number of markets and over the Internet.Third parties may illegally distribute and sell counterfeit versions of our products that do not meet the rigorous manufacturing and testing standardsthat our products undergo. Counterfeit products are frequently unsafe or ineffective and can be potentially life-threatening. Counterfeit medicines maycontain harmful substances, the wrong dose of API or no API at all. However, to distributors and users, counterfeit products may be visually indistinguishablefrom the authentic version.Reports of adverse reactions to counterfeit drugs or increased levels of counterfeiting could materially affect patient confidence in the authenticproduct. It is possible that adverse events caused by unsafe counterfeit products will mistakenly be attributed to the authentic product. In addition,unauthorized diversions of products or thefts of inventory at warehouses, plants, or while in-transit, which are not properly stored, or which are sold throughunauthorized channels, could adversely impact patient safety, our reputation, and our business.Public loss of confidence in the integrity of pharmaceutical products as a result of counterfeiting, diversion, or theft could have a material adverseeffect on our business, reputation, financial condition, results of operations, cash flows, and/or ordinary share price.We face vigorous competition that threatens the commercial acceptance and pricing of our products.The pharmaceutical industry is highly competitive. We face competition from other pharmaceutical manufacturers globally, some of whom aresignificantly larger than we are. Our competitors may be able to develop products and processes competitive with or superior to our own for many reasons,including but not limited to the possibility that they may have:•proprietary processes or delivery systems;•larger or more productive R&D and marketing staff;•larger or more efficient production capabilities in a particular therapeutic area;•more experience in preclinical testing and human clinical trials;•more products; or•more experience in developing new drugs and greater financial resources, particularly with regard to manufacturers of branded products.We also face increasing competition from lower-cost generic products and other branded products. Certain of our products are not protected bypatent rights or have limited patent life and will soon lose patent protection. Loss of patent protection for a product typically is followed promptly by theintroduction of generic substitutes. As a result, sales of many of these products may decline or stop growing over time. Various factors may result in the salesof certain of our products declining faster than has been projected. In addition, legislative proposals emerge from time to time in various jurisdictions tofurther encourage the early and rapid approval of generic drugs. Any such proposal that is enacted into law could increase competition and worsen thisnegative effect on our sales.Competitors’ products may also be safer, more effective, more effectively marketed or sold, or have lower prices or better performance features thanours. We cannot predict with certainty the timing or impact of competitors’ products. PBMs and other19Table of Contentspharmaceutical manufacturers may utilize contracting strategies that could decrease generic utilization and negatively impact our products. In addition, oursales may suffer as a result of changes in consumer demand for our products, including those related to fluctuations in consumer buying patterns tied toseasonality, importation by consumers or the introduction of new products by competitors.The occurrence of any of the above risks could have an adverse effect on our business, financial condition, results of operations, cash flows, and/orordinary share price.A relatively small group of products may represent a significant portion of our revenues, net sales, gross profit, or net earnings from time to time.Sales of a limited number of our products from time to time represent a significant portion of our revenues, net sales, gross profit, and net earnings.For the years ended December 31, 2018 and 2017, Mylan’s top ten products in terms of sales, in the aggregate, represented approximately 20% and 21%,respectively, of the Company’s net sales. If the volume or pricing of our largest selling products declines in the future, our business, financial condition,results of operations, cash flows, and/or ordinary share price could be materially adversely affected.Our business could be negatively affected by the performance of our third-party collaboration partners.We have entered into strategic alliances with partners to develop, manufacture, market and/or distribute certain products, and/or certain componentsof our products, in various markets. We commit substantial effort, funds and other resources to these various collaborations, including with respect to thedevelopment of biosimilar products. There is a risk that the investments made by us in these collaborative arrangements will not generate financial returns.While we believe our relationships with our partners generally are successful, disputes or conflicting priorities and regulatory or legal intervention could be asource of delay or uncertainty as to the expected benefits of the collaboration. In addition, we enter into agreements with our collaboration partners thatprovide for certain services, as well as cross manufacturing, development and licensing arrangements. A failure or inability of our partners to fulfill theircollaboration obligations, or the occurrence of any of the risks above, could have an adverse effect on our business, financial condition, results of operations,cash flows, and/or ordinary share price.We may experience reductions in the levels of reimbursement for pharmaceutical products by governmental authorities, health maintenance organizations(“HMOs”), or other third-party payors. In addition, the use of tender systems and other forms of price control, including legislative or regulatory programsimpacting pharmaceutical prices, could reduce prices for our products or reduce our market opportunities.Various governmental authorities (including, among others, the U.K. National Health Service and the German statutory health insurance scheme)and private health insurers and other organizations, such as HMOs in the U.S., provide reimbursements or subsidies to consumers for the cost of certainpharmaceutical products. Demand for our products depends in part on the extent to which such reimbursement is available. In the U.S., third-party payorsincreasingly challenge the pricing of pharmaceutical products. These trends and other trends toward the growth of HMOs, managed healthcare, andlegislative healthcare reform create significant uncertainties regarding the future levels of reimbursement for pharmaceutical products. Further, anyreimbursement may be reduced in the future to the point that market demand for our products and/or our profitability declines. Such a decline could have amaterial adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.In addition, current or future U.S. federal, U.S. state or other countries’ laws and regulations may influence the prices of drugs and, therefore, couldadversely affect the payments we receive for our products. For example, existing programs in certain U.S. states seek to broadly set prices within those statesthrough the regulation and administration of the sale of prescription drugs. Expansion of these programs, and, in particular, changes to state Medicare and/orMedicaid programs, or changes required in the way in which Medicare payment rates are set and/or the way Medicaid rebates are calculated, could adverselyaffect the payment we receive for our products. In order to control expenditure on pharmaceuticals, most member states in the EU regulate the pricing ofproducts and, in some cases, limit the range of different forms of pharmaceuticals available for prescription by national health services. These controls canresult in considerable price differences between member states.Several countries in which we operate have implemented, or plan to or may implement, government mandated price reductions and/or other controls.When such price controls occur, pharmaceutical companies have generally experienced significant declines in revenues and profitability and uncertaintiescontinue to exist within the market after the price decrease. Such price reductions or controls could have an adverse effect on our business, and asuncertainties are resolved or if other countries in which we operate enact similar measures, they could have a material adverse effect on our business, financialcondition, results of operations, cash flows, and/or ordinary share price.20Table of ContentsA number of markets in which we operate have also implemented or may implement tender systems for generic pharmaceuticals in an effort to lowerprices. Under such tender systems, manufacturers submit bids which establish prices for generic pharmaceutical products. Upon winning the tender, thewinning company will receive a preferential reimbursement for a period of time. The tender system often results in companies underbidding one another byproposing low pricing in order to win the tender. Other markets may also consider the implementation of a tender system or other forms of price controls.Even if a tender system is ultimately not implemented, the anticipation of such could result in price reductions.Failing to win tenders, or the implementation of similar systems or other forms of price controls in other markets leading to further price declines,could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.Healthcare reform legislation could have a material adverse effect on our business.In recent years, there have been numerous initiatives on the federal and state levels for comprehensive reforms affecting the payment for, theavailability of and reimbursement for, healthcare services in the U.S., and it is likely that Congress and state legislatures and health agencies will continue tofocus on healthcare reform in the future. The Patient Protection and Affordable Care Act (“PPACA”) and The Health Care and Education and ReconciliationAct of 2010 (H.R. 4872), which amends the PPACA (collectively, the “Health Reform Laws”), were signed into law in March 2010. While the Health ReformLaws may increase the number of patients who have insurance coverage for our products, they also include provisions such as the assessment of apharmaceutical manufacturer fee and an increase in the amount of rebates that manufacturers pay for coverage of their drugs by Medicaid programs.We are unable to predict the future course of federal or state healthcare legislation. The Health Reform Laws and further changes in the law orregulatory framework that reduce our revenues or increase our costs could have a material adverse effect on our business, financial condition, results ofoperations, cash flows, and/or ordinary share price.Additionally, we encounter similar regulatory and legislative issues in most other countries. In the EU and some other international markets, thegovernment provides healthcare at low cost to consumers and regulates pharmaceutical prices, patient eligibility and/or reimbursement levels to control costsfor the government-sponsored healthcare system. These systems of price regulations may lead to inconsistent and lower prices. Within the EU and in othercountries, the availability of our products in some markets at lower prices undermines our sales in other markets with higher prices. Additionally, certaincountries set prices by reference to the prices in other countries where our products are marketed. Thus, our inability to secure adequate prices in a particularcountry may also impair our ability to obtain acceptable prices in existing and potential new markets, and may create the opportunity for third party crossborder trade.Significant additional reforms to the U.S. healthcare system, or to the healthcare systems of other markets in which we operate, could have a materialadverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.Provisions in our governance arrangements or that are otherwise available under Dutch law could discourage, delay, or prevent a change in control of usand may affect the market price of our ordinary shares.Some provisions of our governance arrangements that are available under Dutch law, such as our grant to a Dutch foundation (stichting) of a calloption to acquire preferred shares to safeguard the interests of the Company, its businesses and its stakeholders against threats to our strategy, mission,independence, continuity and/or identity, may discourage, delay, or prevent a change in control of us, even if such a change in control is sought by ourshareholders.An inability to effectively deal with and respond to unsolicited business proposals could limit our future growth and have a material adverse effect on ourbusiness, financial condition, results of operations, cash flows, and/or ordinary share price.We have in the past and may in the future receive proposals to acquire all of our outstanding shares or similar unsolicited business proposals. Suchunsolicited business proposals may not be consistent with or enhancing to our financial, operational, or market strategies and may not further the interests ofour shareholders and other stakeholders, including employees, creditors, customers, suppliers, relevant patient populations and communities in which Mylanoperates and may jeopardize the sustainable success of Mylan’s business. However, the evaluation of and response to such unsolicited business proposalsmay nevertheless distract management and/or disrupt our ongoing businesses, which may adversely affect our relationships with customers, employees,partners, suppliers, regulators, and others with whom we have business or other dealings.21Table of ContentsThe expansion of social media platforms presents new risks and challenges.To the extent that we seek to use social media tools as a means to communicate about our products and/or business, there are uncertainties as to therules that apply to such communications, or as to the interpretations that authorities will apply to the rules that exist. As a result, despite our efforts to monitorevolving social media communication guidelines and comply with applicable rules, there is risk that our use of social media for such purposes may cause usto be found in violation of them. Our employees may knowingly or inadvertently make use of social media tools in ways that may not be aligned with oursocial media strategy, may give rise to liability, or could lead to the loss of material non-public information, trade secrets or other intellectual property, orpublic exposure of personal information (including sensitive personal information) of our employees, clinical trial patients, customers, and others. Inaddition, negative posts or comments about us on any social media website could damage our reputation. Any of the above risks could have a materialadverse effect on our business, reputation, financial condition, results of operations, cash flows, and/or ordinary share price.Operational RisksOur failure to comply with applicable environmental and occupational health and safety laws and regulations worldwide could adversely impact ourbusiness, financial condition, results of operations, cash flows, and/or ordinary share price.We are subject to various U.S. federal, state, and local and non-U.S. laws and regulations concerning, among other things, the environment, climatechange, regulation of chemicals, employee safety and product safety. These requirements include regulation of the handling, manufacture, transportation,storage, use and disposal of materials, including the discharge of hazardous materials and pollutants into the environment. In the normal course of ourbusiness, we are exposed to risks relating to possible releases of hazardous substances into the environment, which could cause environmental or propertydamage or personal injuries, and which could result in (i) our noncompliance with such environmental and occupational health and safety laws andregulations and (ii) regulatory enforcement actions or claims for personal injury and property damage against us. If an unapproved or illegal environmentaldischarge occurs, or if we discover contamination caused by prior operations, including by prior owners and operators of properties we acquire, we could beliable for cleanup obligations, damages and fines. The substantial unexpected costs we may incur could have a material and adverse effect on our business,financial condition, results of operations, cash flows, and/or ordinary share price. In addition, our environmental capital expenditures and costs forenvironmental compliance may increase substantially in the future as a result of changes in environmental laws and regulations, the development andmanufacturing of a new product or increased development or manufacturing activities at any of our facilities. We may be required to expend significant fundsand our manufacturing activities could be delayed or suspended, which could have a material adverse effect on our business, financial condition, results ofoperations, cash flows, and/or ordinary share price.The pharmaceutical industry is heavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicablelaws and regulations.The pharmaceutical industry is subject to regulation by various governmental authorities. For instance, we must comply with applicable laws andrequirements of the FDA and other regulatory agencies, including foreign authorities, in our other markets with respect to the research, development,manufacture, quality, safety, effectiveness, approval, labeling, tracking, tracing, authentication, storage, record-keeping, reporting, pharmacovigilance, sale,distribution, import, export, marketing, advertising, and promotion of pharmaceutical products. We are committed to conducting our business, including thesales and marketing of our products, in compliance with all applicable laws and regulations. These laws and regulations, however, are numerous and complexand it is possible that a governmental authority may challenge our activities, or that an employee or agent could violate these laws and regulations withoutour knowledge. Failure to comply with regulations of the FDA and other U.S. and foreign regulators could result in a range of consequences, including, butnot limited to, fines, penalties, disgorgement, unanticipated compliance expenditures, suspension of review of applications or other submissions, rejection ordelay in approval of applications, recall or seizure of products, total or partial suspension of production and/or distribution, our inability to sell products, thereturn by customers of our products, injunctions, and/or criminal prosecution. Under certain circumstances, a regulator may also have the authority to revokeor vary previously granted drug approvals.The safety profile of any product will continue to be closely monitored by the FDA and comparable foreign regulatory authorities after approval. Ifthe FDA or comparable foreign regulatory authorities become aware of new safety information about any of our marketed or investigational products, thoseauthorities may require labeling changes, establishment of a risk evaluation and mitigation strategy or similar strategy, restrictions on a product’s indicateduses or marketing, or post-approval studies or post-market surveillance. In addition, we are subject to regulations in various jurisdictions, including theFederal Drug Supply Chain Security Act in the U.S., the Falsified Medicines Directive in the EU and several other such regulations in other countries thatrequire us to develop electronic systems to serialize, track, trace and authenticate units of our products through the supply chain22Table of Contentsand distribution system. Compliance with these regulations may result in increased expenses for us or impose greater administrative burdens on ourorganization, and failure to meet these requirements could result in fines or other penalties.The FDA and comparable regulatory authorities also regulate the facilities and operational procedures that we use to manufacture our products. Wemust register our facilities with the FDA and similar regulators in other countries. Products must be manufactured in our facilities in accordance with cGMP orsimilar standards in each territory in which we manufacture. Compliance with such regulations and with our own quality standards requires substantialexpenditures of time, money, and effort in multiple areas, including training of personnel, record-keeping, production, and quality control and qualityassurance. The FDA and other regulatory authorities, including foreign authorities, periodically inspect our manufacturing facilities for compliance withcGMP or similar standards in the applicable territory. Regulatory approval to manufacture a drug is granted on a site-specific basis. Failure to comply withcGMP and other regulatory standards at one of our or our partners’ or suppliers’ manufacturing facilities could result in an adverse action brought by the FDAor other regulatory authorities, which could result in a receipt of an untitled or warning letter, fines, penalties, disgorgement, unanticipated complianceexpenditures, rejection or delay in approval of applications, suspension of review of applications or other submissions, suspension of ongoing clinical trials,recall or seizure of products, total or partial suspension of production and/or distribution, our inability to sell products, the return by customers of ourproducts, orders to suspend, vary, or withdraw marketing authorizations, injunctions, consent decrees, requirements to modify promotional materials or issuecorrective information to healthcare practitioners, refusal to permit import or export, criminal prosecution and/or other adverse actions.If any regulatory body were to delay, withhold, or withdraw approval of an application; require a recall or other adverse product action; require oneof our manufacturing facilities to cease or limit production; or suspend, vary, or withdraw related marketing authorization, our business could be adverselyaffected. Delay and cost in obtaining FDA or other regulatory approval to manufacture at a different facility also could have a material adverse effect on ourbusiness, financial condition, results of operations, cash flows, and/or ordinary share price.Although we have established internal quality and regulatory compliance programs and policies, there is no guarantee that these programs andpolicies, as currently designed, will meet regulatory agency standards in the future or will prevent instances of non-compliance with applicable laws andregulations. Additionally, despite efforts at compliance, from time to time we or our partners receive notices of manufacturing and quality-relatedobservations following inspections by regulatory authorities around the world, as well as official agency correspondence regarding compliance. For example,on November 9, 2018, the FDA issued a warning letter with respect to our manufacturing plant in Morgantown, West Virginia. This action resulted frompreviously disclosed observations of the plant made by FDA in April 2018. We have implemented comprehensive restructuring and remediation activities atour Morgantown plant, and the issues raised in the warning letter are being addressed within the context of these activities. However, we or our partners mayreceive similar observations and correspondence in the future. If we are unable to resolve these observations and address regulator’s concerns in a timelyfashion, our business, financial condition, results of operations, cash flows, and/or ordinary share price could be materially affected.We utilize controlled substances in certain of our current products and products in development, and therefore must meet the requirements of theControlled Substances Act of 1970 and the related regulations administered by the Drug Enforcement Agency (“DEA”) in the U.S., as well as those of similarlaws in other countries where we operate. These laws relate to the manufacture, shipment, storage, sale, and use of controlled substances. The DEA and otherregulatory agencies limit the availability of the controlled substances used in certain of our current products and products in development and, as a result, ourprocurement quota of these active ingredients may not be sufficient to meet commercial demand or complete clinical trials. We must annually apply to theDEA and similar regulatory agencies for procurement quotas in order to obtain these substances. Any delay or refusal by the DEA or such similar agencies inestablishing our procurement quota for controlled substances could delay or stop our clinical trials or product launches, or could cause trade inventorydisruptions for those products that have already been launched, which could have a material adverse effect on our business, financial condition, results ofoperations, cash flows, and/or ordinary share price.The use of legal, regulatory, and legislative strategies by both brand and generic competitors, including but not limited to “authorized generics” andregulatory petitions, as well as the potential impact of proposed and newly enacted legislation, may increase costs associated with the introduction ormarketing of our generic products, could delay or prevent such introduction, and could significantly reduce our revenue and profit.Our competitors, both branded and generic, often pursue strategies to prevent or delay generic alternatives to branded products. These strategiesinclude, but are not limited to:23Table of Contents•entering into agreements whereby other generic companies will begin to market an authorized generic, which is the approved brand-name drugwithout the brand-name on its label, at the same time or after generic competition initially enters the market;•launching their own authorized generic product prior to or at the same time or after generic competition initially enters the market;•pricing a branded product at a discount equivalent to generic pricing, as was the case for Copaxone after the launch of our generic glatiramer acetateproducts;•filing petitions with the FDA or other regulatory bodies seeking to prevent or delay approvals, including timing the filings so as to thwart genericcompetition by causing delays of our product approvals;•contracting strategies among pharmaceutical manufacturers and PBMs that could decrease generic utilization and negatively impact our productlaunches;•seeking to establish regulatory and legal obstacles that would make it more difficult to demonstrate bioequivalence or to meet other requirements forapproval, and/or to prevent regulatory agency review of applications;•initiating legislative or other efforts to limit the substitution of generic versions of brand pharmaceuticals;•filing suits for patent infringement and other claims that may delay or prevent regulatory approval, manufacture, and/or sale of generic products;•introducing “next-generation” products prior to the expiration of market exclusivity for the reference product, which often materially reduces thedemand for the generic or the reference product for which we seek regulatory approval;•persuading regulatory bodies to withdraw the approval of brand-name drugs for which the patents are about to expire and converting the market toanother product of the brand company on which longer patent protection exists;•obtaining extensions of market exclusivity by conducting clinical trials of brand drugs in pediatric populations or by other methods; and•seeking to obtain new patents on drugs for which patent protection is about to expire.In the U.S., some companies have lobbied Congress for amendments to the Drug Price Competition and Patent Term Restoration Act of 1984 (the“Hatch-Waxman Act”) that would give them additional advantages over generic competitors. For example, although the term of a company’s drug patent canbe extended to reflect a portion of the time a new drug application (“NDA”, which is filed in the U.S. with the FDA when approval is sought to market a newlydeveloped branded product and, in certain instances, for a new dosage form, a new delivery system or a new indication for a previously approved drug) isunder regulatory review, some companies have proposed extending the patent term by a full year for each year spent in clinical trials rather than the one-halfyear that is currently permitted.If proposals like these in the U.S., Europe, or in other countries where we or our partners and suppliers operate were to become effective, or if anyother actions by our competitors and other third parties to prevent or delay activities necessary to the approval, manufacture, or distribution of our productsare successful, our entry into the market and our ability to generate revenues associated with new products may be delayed, reduced, or eliminated, whichcould have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.If we are unable to successfully introduce new products in a timely manner, our future revenue and profitability may be adversely affected.Our future revenues and profitability will depend, in part, upon our ability to successfully and timely develop, license, or otherwise acquire andcommercialize new products. Product development is inherently risky, especially for new drugs for which safety and efficacy have not been establishedand/or the market is not yet proven as well as for complex generic drugs and biosimilars. Likewise, product licensing involves inherent risks, including,among others, uncertainties due to matters that may affect the achievement of milestones, as well as the possibility of contractual disagreements with regardto whether the supply of product meets certain specifications or terms such as license scope or termination rights. The development and commercializationprocess, particularly with regard to new and complex drugs, also requires substantial time, effort and financial resources. We, or a partner, may not besuccessful in commercializing such products on a timely basis, or at all, which could adversely affect our business, financial condition, results of operations,cash flows, and/or ordinary share price.Before any prescription drug product, including generic drug products, can be marketed, marketing authorization approval is required by therelevant regulatory authorities and/or national regulatory agencies (for example, the FDA in the U.S. and the EMA in the EU). The process of obtainingregulatory approval to manufacture and market new branded and generic pharmaceutical products is rigorous, time consuming, costly, and inherentlyunpredictable. In addition, these regulatory agencies may be delayed24Table of Contentsin reviewing and approving products as a result of lapsed or insufficient funding, insufficient staffing or other factors beyond our control. As a result ofBrexit, the EU has decided to move the headquarters of the EMA from the U.K. to the Netherlands by March 2019, which raises the possibility that anyexisting and/or new regulatory approval applications in the EU, whether for existing or new drug products, could be delayed as a result. Any delay inregulatory approval could impact the commercial or financial success of a product.Outside the U.S., the approval process may be more or less rigorous, depending on the country, and the time required for approval may be longer orshorter than that required in the U.S. Bioequivalence, clinical, or other studies conducted in one country may not be accepted in other countries, therequirements for approval may differ among countries, and the approval of a pharmaceutical product in one country does not necessarily mean that theproduct will be approved in another country. We, or a partner or supplier, may be unable to obtain requisite approvals on a timely basis, or at all, for newproducts that we may develop, license or otherwise acquire. Moreover, if we obtain regulatory approval for a drug, it may be limited, for example, withrespect to the indicated uses and delivery methods for which the drug may be marketed, or may include warnings, precautions or contraindications in thelabeling, which could restrict our potential market for the drug. A regulatory approval may also include post-approval study or risk management requirementsthat may substantially increase the resources required to market the drug. Also, for products pending approval, we may obtain raw materials or producebatches of inventory to be used in efficacy and bioequivalence testing, as well as in anticipation of the product’s launch. In the event that regulatoryapproval is denied or delayed, we could be exposed to the risk of this inventory becoming obsolete.The approval process for generic pharmaceutical products often results in the relevant regulatory agency granting final approval to a number ofgeneric pharmaceutical products at the time a patent claim for a corresponding branded product or other market exclusivity expires. This often forces us toface immediate competition when we introduce a generic product into the market. Additionally, further generic approvals often continue to be granted for agiven product subsequent to the initial launch of the generic product. These circumstances generally result in significantly lower prices, as well as reducedmargins, for generic products compared to branded products. New generic market entrants generally cause continued price, margin, and sales erosion over thegeneric product life cycle.In the U.S., the Hatch-Waxman Act provides for a period of 180 days of generic marketing exclusivity for a “first applicant,” that is the firstsubmitted Abbreviated New Drug Application (“ANDA”, which is filed in the U.S. with the FDA when approval is sought to market a generic equivalent of adrug product previously approved under an NDA and listed in the FDA publication entitled Approved Drug Products with Therapeutic EquivalenceEvaluations, popularly known as the “Orange Book” or for a new dosage strength for a drug previously approved under an ANDA) containing a certificationof invalidity, non-infringement or unenforceability related to a patent listed with the ANDA’s reference drug product, commonly referred to as a Paragraph IVcertification. During this exclusivity period, which under certain circumstances may be shared with other ANDAs filed on the same day, the FDA cannot grantfinal approval to later-submitted ANDAs for the same generic equivalent. If an ANDA is awarded 180-day exclusivity, the applicant generally enjoys highermarket share, net revenues, and gross margin for that generic product. However, our ability to obtain 180 days of generic marketing exclusivity may bedependent upon our ability to obtain FDA approval or tentative approval within an applicable time period of the FDA’s acceptance of our ANDA. If we areunable to obtain approval or tentative approval within that time period, we may risk forfeiture of such marketing exclusivity. By contrast, if we are not a “firstapplicant” to challenge a listed patent for such a product, we may lose significant advantages to a competitor with 180-day exclusivity, even if we obtainFDA approval for our generic drug product. The same would be true in situations where we are required to share our exclusivity period with other ANDAsponsors with Paragraph IV certifications.In the EU and other countries and regions, there is no exclusivity period for the first generic product. The European Commission or nationalregulatory agencies may grant marketing authorizations to any number of generics.If we are unable to navigate our products through the approval process in a timely manner, there could be an adverse effect on our productintroduction plans, business, financial condition, results of operations, cash flows, and/or ordinary share price.We expend a significant amount of resources on R&D efforts that may not lead to successful product introductions.Much of our development effort is focused on technically difficult-to-formulate products and/or products that require advanced manufacturingtechnology, including our biosimilars program and respiratory platform. We conduct R&D primarily to enable us to gain approval for, manufacture, andmarket pharmaceuticals in accordance with applicable laws and regulations. We also partner with third parties to develop products. Typically, researchexpenses related to the development of innovative or complex compounds and the filing of marketing authorization applications for innovative and complexcompounds (such as NDAs and biosimilar applications in the U.S.) are significantly greater than those expenses associated with the development of and filingof marketing authorization applications for most generic products (such as ANDAs in the U.S. and abridged applications in Europe).25Table of ContentsAs we and our partners continue to develop new and/or complex products, our research expenses will likely increase. Because of the inherent risk associatedwith R&D efforts in our industry, including the high cost and uncertainty of conducting clinical trials (where required) particularly with respect to new and/orcomplex drugs, our, or a partner’s, R&D expenditures may not result in the successful introduction of new pharmaceutical products approved by the relevantregulatory bodies. Also, after we submit a marketing authorization application for a new compound or generic product, the relevant regulatory authority maychange standards and/or request that we conduct additional studies or evaluations and, as a result, we may incur approval delays as well as R&D costs inexcess of what we anticipated.Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during theclinical trial process. We or our partners may experience delays in our ongoing or future clinical trials, and we do not know whether planned clinical trialswill begin or enroll subjects on time, need to be redesigned, or be completed on schedule, if at all.Clinical trials may be delayed, suspended or prematurely terminated for a variety of reasons. If we experience delays in the completion of, or thetermination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generateproduct revenues from any of these product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slowdown our product candidate development and approval process, and jeopardize our ability to commence product sales and generate revenues. Any of theseoccurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in thecommencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.Finally, we cannot be certain that any investment made in developing products will be recovered, even if we are successful in commercialization. Tothe extent that we expend significant resources on R&D efforts and are not able, ultimately, to introduce successful new and/or complex products as a resultof those efforts, there could be a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.Even if our products in development receive regulatory approval, such products may not achieve expected levels of market acceptance.Even if we are able to obtain regulatory approvals for our new products, the success of those products is dependent upon market acceptance. Levelsof market acceptance for our products could be impacted by several factors, including but not limited to:•the availability, perceived advantages, and relative safety and efficacy of alternative products from our competitors;•the degree to which the approved labeling supports promotional initiatives for commercial success;•the prices of our products relative to those of our competitors;•the timing of our market entry;•the effectiveness of our marketing, sales, and distribution strategy and operations; and•other competitor actions, including legal actions.Additionally, studies of the proper utilization, safety, and efficacy of pharmaceutical products are being conducted by the industry, governmentagencies, and others. Such studies, which increasingly employ sophisticated methods and techniques, can call into question the utilization, safety, andefficacy of previously marketed as well as future products. In some cases, such studies have resulted, and may in the future result, in the discontinuation orvariation of product marketing authorizations or requirements for risk management programs, such as a patient registry. Any of these events could adverselyaffect our profitability, business, financial condition, results of operations, cash flows, and/or ordinary share price.The development, approval process, manufacture and commercialization of biosimilar products involve unique challenges and uncertainties, and ourfailure to successfully introduce biosimilar products could have a negative impact on our business and future operating results.We and our partners and suppliers are actively working to develop and commercialize biosimilar products. Although the Biologics PriceCompetition and Innovation Act of 2009 (“BPCIA”) established a framework for the review and approval of biosimilar products and the FDA has begun toreview and approve biosimilar product applications, there continues to be significant uncertainty regarding the regulatory pathway in the U.S., with the FDAcontinuing to issue and revise guidance related to its26Table of Contentsinterpretation and implementation of the BPCIA. There is also uncertainty regarding the pathway to obtain approval for biosimilar products in othercountries as well as uncertainty regarding the commercial pathway to successfully market and sell such products.Moreover, biosimilar products generally involve extensive patent clearances and often involve patent infringement litigation related to multiplepatents, which could delay or prevent the commercial launch of a biosimilar product for many years. If we are unable to obtain FDA or other non-U.S.regulatory authority approval for our products, we will be unable to market them. In addition, the development and manufacture of biosimilars pose uniquechallenges related to the supply of the materials needed to manufacture biosimilars. Access to and the supply of necessary biological materials may belimited, and government regulations restrict access to and regulate the transport and use of such materials.Even if our biosimilar products are approved for marketing, the products may not be commercially successful, may require more time than expectedto achieve market acceptance, and may not generate profits in amounts that are sufficient to offset the amount invested to obtain such approvals. Marketsuccess of biosimilar products will depend on demonstrating to regulators, patients, physicians and payors (such as insurance companies) that such productsare safe and effective yet offer a more competitive price or other benefit over existing therapies. In addition, manufacturers of biologic products may try todissuade physicians from prescribing or accepting biosimilar products. We may not be able to generate future sales of biosimilar products in certainjurisdictions and may not realize the anticipated benefits of our investments in the development, manufacture and sale of such products. If our developmentefforts do not result in the development and timely approval of biosimilar products or if such products, once developed and approved, are not commerciallysuccessful, or upon the occurrence of any of the above risks, our business, financial condition, results of operations, cash flows, and/or ordinary share pricecould be materially adversely affected.Our business is highly dependent upon market perceptions of us, our products, and the safety and quality of our products, and may be adversely impactedby negative publicity or findings.Market perceptions of us are very important to our business, especially market perceptions of our company, products and the safety and quality ofour products. If we, our partners and suppliers, or our products suffer from negative publicity, or if any of our products or similar products which othercompanies distribute are subject to market withdrawal or recall or are proven to be, or are claimed to be, ineffective or harmful to consumers, then this couldhave a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price. Also, because we aredependent on market perceptions, negative publicity associated with product quality, patient illness, or other adverse effects resulting from, or perceived tobe resulting from, our products, or our partners’ and suppliers’ manufacturing facilities, could have a material adverse effect on our business, financialcondition, results of operations, cash flows, and/or ordinary share price.A significant portion of our revenues is derived from sales to a limited number of customers.A significant portion of our revenues is derived from sales to a limited number of customers. If we were to experience a significant reduction in orloss of business with one or more such customers, or if one or more such customers were to experience difficulty in paying us on a timely basis, our business,financial condition, results of operations, cash flows, and/or ordinary share price could be materially adversely affected.In addition, a significant amount of our sales are to a relatively small number of drug wholesalers and retail drug chains. These customers representan essential part of the distribution chain of generic pharmaceutical products. Drug wholesalers and retail drug chains have undergone, and are continuing toundergo, significant consolidation. This consolidation has resulted in these groups gaining additional purchasing leverage and, consequently, increasing theproduct pricing pressures facing our business. We expect this trend of increased pricing pressures to continue. Additionally, the emergence of large buyinggroups representing independent retail pharmacies and the prevalence and influence of managed care organizations and similar institutions increases thenegotiating power of these groups, enabling them to attempt to extract price discounts, rebates, and other restrictive pricing terms on our products. Thesefactors could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.During the years ended December 31, 2018, 2017 and 2016, Mylan’s consolidated net sales to its three largest customers were approximately: 8%,10%, and 11%, respectively, to Cardinal Health, Inc.; 12%, 13%, and 16%, respectively, to McKesson Corporation; and 8%, 8%, and 14%, respectively, toAmerisourceBergen Corporation.The supply of API into Europe may be negatively affected by recent regulations promulgated by the EU.All API imported into the EU has needed to be certified as complying with the good manufacturing practice standards established by the EU lawsand guidance, as stipulated by the International Conference for Harmonization. These regulations place the certification requirement on the regulatory bodiesof the exporting countries. Accordingly, the national regulatory authorities27Table of Contentsof each exporting country must: (i) ensure that all manufacturing plants within their borders that export API into the EU comply with EU manufacturingstandards and (ii) for each API exported, present a written document confirming that the exporting plant conforms to EU manufacturing standards. Theimposition of this responsibility on the governments of the nations exporting an API may cause delays in delivery or shortages of an API necessary tomanufacture our products, as certain governments may not be willing or able to comply with the regulation in a timely fashion, or at all. A shortage in APImay prevent us from manufacturing, or cause us to have to cease manufacture of, certain products, or to incur costs and delays to qualify other suppliers tosubstitute for those API manufacturers unable to export. The occurrence of any of the above risks could have a material adverse effect on our business,financial condition, results of operations, cash flows, and/or ordinary share price.We have a limited number of manufacturing facilities and certain third-party suppliers produce a substantial portion of our API and products, some ofwhich require a highly exacting and complex manufacturing process.A substantial portion of our capacity, as well as our current production, is attributable to a limited number of manufacturing facilities and certainthird-party suppliers. A significant disruption at any one of such facilities within our internal or third-party supply chain, even on a short-term basis, whetherdue to the failure of a third-party supplier to fulfill the terms of their agreement with us, labor disruption, adverse quality or compliance observation, otherregulatory action, infringement of brand or other third-party intellectual property rights, natural disaster, civil or political unrest, export or import restrictions,or other events could impair our ability to produce and ship products to the market on a timely basis and could, among other consequences, subject us toexposure to claims from customers. Any of these events could have a material adverse effect on our reputation, business, financial condition, results ofoperations, cash flows, and/or ordinary share price. If we or our third-party suppliers’ face significant manufacturing issues, this could lead to shutdowns orproduct shortages, or to our being entirely unable to supply certain products to customers for an extended period of time. Such shortages or shutdowns haveled and could continue to lead to significant losses of sales revenue, third-party litigation, or negative publicity. See also “The pharmaceutical industry isheavily regulated, and we face significant costs and uncertainties associated with our efforts to comply with applicable laws and regulations.”We purchase certain API and other materials and supplies that we use in our manufacturing operations, as well as certain finished products, frommany different foreign and domestic suppliers. The price of API and other materials and supplies is subject to volatility, and in certain cases, we have listedonly one supplier in our applications with regulatory agencies. There is no guarantee that we will always have timely, sufficient or affordable access tocritical raw materials or finished product supplied by third parties, even when we have more than one supplier. An increase in the price, or an interruption inthe supply, of a single-sourced or any other raw material, including the relevant API, or in the supply of finished product, could cause our business, financialcondition, results of operations, cash flows, and/or ordinary share price to be materially adversely affected. Quality deficiencies in the products which oursuppliers provide, or at their manufacturing facilities, could adversely impact our manufacturing and supply capabilities, cause supply interruptions, or leadto voluntary market withdrawals or product recalls.In addition, the manufacture of some of our products is a highly exacting and complex process, due in part to strict regulatory requirements.Problems may arise during manufacturing at our or our third-party suppliers’ facilities for a variety of reasons, including, among others, equipmentmalfunction, failure to follow specific protocols and procedures, problems with raw materials, natural disasters, power outages, labor unrest, andenvironmental factors. If problems arise during the production of a batch of product, that batch of product may have to be discarded. This could, among otherthings, lead to increased costs, lost revenue, damage to customer relations, time and expense spent investigating the cause, and, depending on the cause,similar losses with respect to other batches or products. If problems are not discovered before the product is released to the market, recall and product liabilitycosts may also be incurred.If we or one of our suppliers experience any of the problems described above, such problems could have a material adverse effect on our reputation,business, financial condition, results of operations, cash flows, and/or ordinary share price.Our future success is highly dependent on our continued ability to attract and retain key personnel.It is important that we attract and retain qualified personnel in order to develop and commercialize new products, manage our business, and competeeffectively. Competition for qualified personnel in the pharmaceutical industry is very intense. If we fail to attract, develop, incentivize and retain keyscientific, technical, commercial, regulatory or management personnel, this could lead to loss of customers, business disruption, and a decline in revenues,adversely affect the progress of pipeline products, or otherwise adversely affect our operations. Additionally, while we work to ensure that we have effectiveplans in place for management succession, any anticipated or unanticipated management transition could create uncertainty, which could disrupt or result inchanges to our strategy and have a negative impact on our business. While we have employment agreements with certain key employees in place, theiremployment for the duration of the agreement is not guaranteed. Current and prospective employees might also experience uncertainty about their futureroles with us following the consummation and integration of recent acquisitions and potential future transactions, which might adversely affect our ability toretain key managers and other employees. If we are28Table of Contentsunsuccessful in retaining our key employees or enforcing certain post-employment contractual provisions such as confidentiality or non-competitionprovisions, it could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.We are in the process of enhancing and further developing our global ERP systems and associated business applications, which could result in businessinterruptions if we encounter difficulties.We are enhancing and further developing our global ERP and other business critical IT infrastructure systems and associated applications to providemore operating efficiencies and effective management of our business and financial operations. Such changes to ERP systems and related software, and otherIT infrastructure carry risks such as cost overruns, project delays and business interruptions and delays. If we experience a material business interruption as aresult of our ERP enhancements, it could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinaryshare price.Compliance RisksWe are subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and similar worldwide anti-corruption laws, which impose restrictions oncertain conduct and may carry substantial fines and penalties.We are subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and similar anti-corruption laws in other jurisdictions. These lawsgenerally prohibit companies and their intermediaries from engaging in bribery or making other prohibited payments to government officials for the purposeof obtaining or retaining business, and some have record keeping requirements. The failure to comply with these laws could result in substantial criminaland/or monetary penalties. We operate in jurisdictions that have experienced corruption, bribery, pay-offs and other similar practices from time-to-time and,in certain circumstances, such practices may be local custom. We have implemented internal control policies and procedures that mandate compliance withthese anti-corruption laws. However, we cannot be certain that these policies and procedures will protect us against liability. There can be no assurance thatour employees or other agents will not engage in such conduct for which we might be held responsible. If our employees or agents are found to have engagedin such practices, we could suffer severe criminal or civil penalties and other consequences that could have a material adverse effect on our business, financialcondition, results of operations, cash flows, and/or ordinary share price.Our competitors, including branded pharmaceutical companies, and/or other third parties, may allege that we or our suppliers are infringing upon theirintellectual property, including in an “at risk launch” situation, which could result in substantial monetary damages, impact our ability to launch aproduct and/or our ability to continue marketing a product, and/or force us to expend substantial resources in resulting litigation, the outcome of which isuncertain.Companies that produce branded pharmaceutical products and other patent holders routinely bring litigation against entities selling or seekingregulatory approval to manufacture and market generic forms of their branded products, as well as other entities involved in the manufacture, supply, andother aspects relating to API and finished pharmaceutical products. These companies and other patent holders may allege patent infringement or otherviolations of intellectual property rights as the basis for filing suit against an applicant for a generic product as well as others who may be involved in someaspect of research, supply, production, distribution, testing, packaging or other processes. Litigation often involves significant expense and can delay orprevent introduction or sale of our generic products. If patents are held valid and infringed by our products in a particular jurisdiction, we and/or oursupplier(s) or partner(s) may, unless we or the supplier(s) or partner(s) could obtain a license from the patent holder, need to cease manufacturing and otheractivities, including but not limited to selling in that jurisdiction. We may also need to pay damages, surrender or withdraw the product, or destroy existingstock in that jurisdiction.There also may be situations, including, for example, the decision to launch our 40mg/mL glatiramer acetate and Fulphila products, where we useour business judgment and decide to market, and sell products, directly or through third parties, notwithstanding the fact that allegations of patentinfringement(s) and other third-party rights have not been finally resolved by the courts (i.e., an “at-risk launch”). The risk involved in doing so can besubstantial because the remedies available to the owner of a patent for infringement may include, among other things, a reasonable royalty on sales, damagesmeasured by the profits lost by the patent holder, or by profits earned by the infringer. If there is a finding by a court of willful infringement, the definition ofwhich is subjective, such damages may be increased by up to three times. Moreover, because of the discount pricing typically involved with bioequivalentproducts, patented branded products generally realize a substantially higher profit margin than generic or biosimilar products. An adverse decision in a casesuch as this, or a judicial order preventing us or our suppliers and partners from manufacturing, marketing, selling, and/or other activities necessary to themanufacture and distribution of our products, could result in substantial penalties, and/or have a material adverse effect on our business, financial condition,results of operations, cash flows, and/or ordinary share price.29Table of ContentsWe rely on the effectiveness of our patents, confidentiality agreements and other measures to protect our intellectual property rights.Our ability to commercialize any branded product successfully will largely depend upon our or any partner’s or supplier’s ability to obtain andmaintain patents and trademarks of sufficient scope to lawfully prevent third parties from developing and/or marketing infringing products. In the absence ofintellectual property or other protection, competitors may adversely affect our branded products business by independently developing and/or marketingsubstantially equivalent products. It is also possible that we could incur substantial costs if we are required to initiate litigation against others to protect orenforce our intellectual property rights.We have filed and/or own patent filings covering the API or formulation of, methods of making, and/or methods of using, our branded products andbranded product candidates. We may not be issued patents based on patent applications already filed or that we file in the future. Further, due to other factorsthat affect patentability, and if patents are issued, they may be insufficient in scope to cover or otherwise protect our branded products. Patents are national inscope and therefore the issuance of a patent in one country does not ensure the issuance of a patent in any other country. Furthermore, the patent position ofcompanies in the pharmaceutical industry generally involves complex legal and factual questions and has been and remains the subject of significantlitigation. Legal standards relating to scope and validity of patent claims are evolving and may differ in various countries. Any patents we have obtained, orobtain in the future, may be challenged, invalidated or circumvented. Moreover, the U.S. Patent and Trademark Office or any other governmental agency maycommence inter partes review or interference proceedings involving, or consider other challenges to, our patents or patent applications. In addition, brandedproducts often have market viability based upon the goodwill of the product name, which typically benefits from trademark protection. Our branded productsmay therefore also be subject to risks related to the loss of trademark or patent protection or to competition from generic or other branded products.Challenges can come from other businesses, individuals or governments, and governments could require compulsory licensing of this intellectual property.Any challenge to, or invalidation or circumvention of, our intellectual property (including patents or patent applications, copyrights and trademarkprotection) would be costly, would require significant time and attention of our management, and could cause a material adverse effect on our business,financial condition, results of operations, cash flows, and/or ordinary share price.We also rely on trade secrets, unpatented proprietary know-how, trademarks, regulatory exclusivity and continuing technological innovation thatwe seek to protect, in part by confidentiality agreements with licensees, suppliers, employees and consultants. These measures may not provide adequateprotection for our unpatented technology. If these agreements are breached, it is possible that we will not have adequate remedies. Disputes may ariseconcerning the ownership of intellectual property or the applicability of confidentiality agreements. Furthermore, our trade secrets and proprietarytechnology may otherwise become known or be independently developed by our competitors or we may not be able to maintain the confidentiality ofinformation relating to such products. If we are unable to adequately protect our technology, trade secrets or proprietary know-how, or enforce ourintellectual property rights, this could cause a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinaryshare price.Our reporting and payment obligations related to our participation in U.S. federal healthcare programs, including Medicare, Medicaid and theDepartment of Veterans Affairs (the “VA”), are complex and often involve subjective decisions that could change as a result of new businesscircumstances, new regulations or agency guidance, or advice of legal counsel. Any failure to comply with those obligations could subject us toinvestigation, penalties, and sanctions.U.S. federal laws regarding reporting and payment obligations with respect to a pharmaceutical company’s participation in federal healthcareprograms, including Medicare, Medicaid and the VA, are complex. Because our processes for calculating applicable government prices and the judgmentsinvolved in making these calculations involve subjective decisions and complex methodologies, these calculations are subject to risk of errors and differinginterpretations. In addition, they are subject to review and challenge by the applicable governmental agencies, and it is possible that such reviews couldresult in changes that may have material adverse legal, regulatory, or economic consequences.Pharmaceutical manufacturers that participate in the Medicaid Drug Rebate Program, such as Mylan, are required to report certain pricing data to theCenters for Medicare & Medicaid Services (“CMS”), the federal agency that administers the Medicare and Medicaid programs. This data includes theAverage Manufacturer Price (“AMP”) for each of the manufacturer’s covered outpatient drugs. CMS calculates a type of U.S. federal ceiling on reimbursementrates to pharmacies for multiple source drugs under the Medicaid program, known as the federal upper limit (“FUL”). Since April 2016, CMS is required touse the weighted average AMP for pharmaceutically and therapeutically equivalent multiple source drugs to calculate FULs, instead of the other pricing dataCMS previously used. Although weighted average AMP-based FULs do not reveal Mylan’s individual AMP, publishing a weighted average AMP availableto customers and the public at large could negatively affect our commercial price negotiations.30Table of ContentsIn addition, a number of state and federal government agencies are conducting investigations of manufacturers’ reporting practices with respect toAverage Wholesale Prices (“AWP”). The government has alleged that reporting of inflated AWP has led to excessive payments for prescription drugs, and wemay be named as a defendant in actions relating to pharmaceutical pricing issues and whether allegedly improper actions by pharmaceutical manufacturersled to excessive payments by Medicare, Medicaid and/or the VA.Any governmental agencies or authorities that have commenced, or may commence, an investigation of us relating to the sales, marketing, pricing,quality, or manufacturing of pharmaceutical products could seek to impose, based on a claim of violation of anti-fraud and false claims laws or otherwise,civil and/or criminal sanctions, including fines, penalties, and possible exclusion from federal healthcare programs, including Medicare, Medicaid and/or theVA. Some of the applicable laws may impose liability even in the absence of specific intent to defraud. Furthermore, should there be ambiguity with regard tohow to properly calculate and report payments - and even in the absence of any such ambiguity - a governmental authority may take a position contrary to aposition we have taken, and may impose or pursue civil and/or criminal sanctions. Governmental agencies may also make changes in program interpretations,requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. There can be no assurance thatour submissions will not be found by CMS or the VA to be incomplete or incorrect. Any failure to comply with the above laws and regulations, and any suchpenalties or sanctions could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.We are involved in various legal proceedings and certain government inquiries and may experience unfavorable outcomes of such proceedings orinquiries.We are or may be involved in various legal proceedings and certain government inquiries or investigations, including, but not limited to, patentinfringement, product liability, antitrust matters, breach of contract, and claims involving Medicare, Medicaid and/or VA reimbursements, or laws relating tosales, marketing, and pricing practices, some of which are described in our periodic reports, that involve claims for, or the possibility of, fines and penaltiesinvolving substantial amounts of money or other relief, including but not limited to civil or criminal fines and penalties and exclusion from participation invarious government healthcare-related programs. With respect to government antitrust enforcement and private plaintiff litigation of so-called “pay fordelay” patent settlements, large verdicts, settlements or government fines are possible, especially in the U.S. and EU. If any of these legal proceedings orinquiries were to result in an adverse outcome, the impact could have a material adverse effect on our business, financial condition, results of operations, cashflows, and/or ordinary share price. Refer to Note 19 Litigation included in Item 8 in this Annual Report on Form 10-K for further discussion of litigationmatters.Emerging developments in the U.S. legal landscape relative to the liability of generic pharmaceutical manufacturers for certain product liabilitiesclaims could increase our exposure litigation costs and damages. Although we maintain a combination of self-insurance and commercial insurance, noreasonable amount of insurance can fully protect against all risks because of the potential liability inherent in the business of producing pharmaceuticals forhuman consumption. To the extent that a loss occurs, depending on the nature of the loss and the level of insurance coverage maintained, it could have amaterial adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.In addition, in limited circumstances, entities that we have acquired are party to litigation in matters under which we are, or may be, entitled toindemnification by the previous owners. Even in the case of indemnification, there are risks inherent in such indemnities and, accordingly, there can be noassurance that we will receive the full benefits of such indemnification, or that we will not experience an adverse result in a matter that is not indemnified,which could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.If we fail to comply with our corporate integrity agreement, we could be subject to substantial penalties and exclusion from participation in federalhealthcare programs.In August 2017, Mylan Inc. and Mylan Specialty L.P. entered into a Corporate Integrity Agreement (the “CIA”) with the Office of Inspector Generalof the Department of Health and Human Services (“OIG-HHS”). The CIA has a five-year term and requires, among other things, enhancements to ourcompliance program, fulfillment of reporting and monitoring obligations, management certifications and resolutions from Mylan Inc.’s board, as well as thatan independent review organization annually review various matters relating to the Medicaid Drug Rebate Program, among other things. If we fail to complywith the CIA, the OIG-HHS may impose substantial monetary penalties or exclude us from federal healthcare programs, including Medicare, Medicaid or theVA, which could have a material adverse effect on our business, financial condition and results of operations.31Table of ContentsWe are increasingly dependent on IT and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.Significant disruptions to our IT systems or breaches of information security could adversely affect our business. We are increasingly dependent onsophisticated IT systems and infrastructure to operate our business. We also have outsourced significant elements of our operations to third parties, some ofwhich are outside the U.S., including significant elements of our IT infrastructure, and as a result we are managing many independent vendor relationshipswith third parties who may or could have access to our confidential information. The size and complexity of our IT systems, and those of our third-partyvendors with whom we contract, make such systems potentially vulnerable to service interruptions. In addition, we and our vendors could be susceptible tothird-party attacks on our IT systems. Such attacks are increasingly sophisticated and are made by groups and individuals with a wide range of motives andexpertise, including state and quasi-state actors, criminal groups, “hackers” and others. Any security breach or other disruption to our or our vendors’ ITinfrastructure could also interfere with or disrupt our business operations, including our manufacturing, distribution, R&D, sales and/or marketing activities.In the ordinary course of business, we and our vendors collect, store and transmit large amounts of confidential information (including trade secretsor other intellectual property, proprietary business information and personal information), and it is critical that we do so in a secure manner to maintain theconfidentiality and integrity of such confidential information. The size and complexity of our and our vendors’ systems and the large amounts of confidentialinformation that is present on them also makes them potentially vulnerable to security breaches from inadvertent or intentional actions by our employees,partners or vendors, or from attacks by malicious third parties. Maintaining the security, confidentiality and integrity of this confidential information(including trade secrets or other intellectual property, proprietary business information and personal information) is important to our competitive businessposition. However, such information can be difficult to protect. While we have taken steps to protect such information, and to ensure that the third-partyvendors’ on which we rely have taken adequate steps to protect such information, there can be no assurance that our or our vendors’ efforts will preventservice interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential or material non-publicinformation that could adversely affect our business operations or result in the loss, misappropriation, and/or unauthorized access, use or disclosure of, or theprevention of access to, confidential information.A breach of our or our vendors’ security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation ormisuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms ofdeception, or for any other cause, could enable others to produce competing products, use our proprietary technology or information, and/or adversely affectour business position. Further, any such interruption, security breach, or loss, misappropriation, and/or unauthorized access, use or disclosure of confidentialinformation, including personal information regarding our patients and employees, could result in financial, legal, business, and reputational harm to us andcould have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.We are subject to data privacy and security laws and regulations in many different jurisdictions and countries where we do business, and our or ourvendors’ inability to comply could result in fines, penalties, reputational damage, and could impact the way we operate our business.We are subject to laws and regulations governing the collection, use and transmission of personal information, including health information. As thelegislative and regulatory landscape for data privacy and protection continues to evolve around the world, there has been an increasing focus on privacy anddata protection issues that may affect our business, including the U.S.’s federal Health Insurance Portability and Accountability Act of 1996, as amended(“HIPAA”), the EU’s General Data Protection Regulation (“GDPR”), and other laws and regulations described below.In the U.S., we may be subject to state security breach notification laws, state health information privacy laws and federal and state consumerprotections laws which impose requirements for the collection, use, disclosure and transmission of personal information. Each of these laws are subject tovarying interpretations by courts and government agencies, creating complex compliance issues for us. If we, or the third-party vendors’ on which we rely,fail to comply with applicable laws and regulations we could be subject to fines, penalties or sanctions, including criminal penalties if we knowingly obtainindividually identifiable health information from a covered entity in a manner that is not authorized or permitted by HIPAA or for aiding and abetting theviolation of HIPAA.In addition, EU member states and other jurisdictions have adopted data protection laws and regulations that impose significant complianceobligations. Implementation of the GDPR in EU member states in May 2018 introduced new data protection requirements in the EU and established aframework to govern data sharing and collection and related consumer privacy rights. The GDPR imposed significant compliance obligations, including theimplementation of a number of processes and policies around our data collection and use. In addition, the GDPR includes significant penalties for non-compliance, with fines up to the higher32Table of Contentsof €20 million or 4% of total annual worldwide revenue. In general, GDPR, and other local privacy laws, could require adaptation of our technologies orpractices to satisfy local privacy requirements and standards that may be more stringent than in the U.S.Other countries in which we do business have, or are developing, laws governing the collection, use and transmission of personal information as wellthat may affect our business or require us to adapt our technologies or practices. These include Canada and several Latin American and Asian countries,which have constitutional protections for, or have adopted legislation protecting, individuals’ personal information. Other countries, including Australia andJapan, have established specific legal requirements for cross-border transfers of personal information. Some countries, including India, are consideringlegislation implementing data protection requirements or requiring local storage and processing of data or similar requirements.These and similar initiatives could increase the cost of developing, implementing or maintaining our IT systems, require us to allocate moreresources to compliance initiatives or increase our costs. In addition, a failure by us, or our third-party vendors, to comply with applicable data privacy andsecurity laws could result in financial, legal, business, and reputational harm to us and could have a material adverse effect on the way we operate ourbusiness, our financial condition, results of operations, cash flows, and/or ordinary share price.Increasing scrutiny and changing expectations from customers, regulators, investors, and other stakeholders with respect to our environmental, social andgovernance practices may impose additional costs on us or expose us to new or additional risks.Companies are facing increasing scrutiny from customers, regulators, investors, and other stakeholders related to their environmental, social andgovernance practices. Investor advocacy groups, investment funds and influential investors are also increasingly focused on these practices, especially asthey relate to the environment, health and safety, supply chain management, diversity and human rights. Failure to adapt to or comply with regulatoryrequirements or investor or stakeholder expectations and standards could negatively impact our reputation and the price of our ordinary shares.In addition, a number of our customers, including certain government purchasers, have adopted, or may adopt, procurement policies that includesocial and environmental requirements, or these customers may seek to include such provisions in their procurement contract terms and conditions. Thesesocial and environmental responsibility provisions and initiatives are subject to change, vary from jurisdiction to jurisdiction, and certain elements may bedifficult and/or cost prohibitive for us to comply with given the inherent complexity of our external supply chain and the global scope of our operations. Incertain circumstances, in order to meet the requirements or standards of our customers, we may be obligated to modify our sourcing practices or make otheroperational choices which may require additional investments and increase our costs or result in inefficiencies. Alternatively, we may be ineligible toparticipate in bids or tenders in certain markets, which may result in lost sales and revenues.Any of the factors mentioned above, or the perception that we or our suppliers or contract manufacturers have not responded appropriately to thegrowing concern for such issues, regardless of whether we are legally required to do so, may damage our reputation and have a material adverse effect on ourbusiness, financial condition, results of operations cash flows and/or ordinary share price.Finance RisksWe expect to be treated as a non-U.S. corporation for U.S. federal income tax purposes. Any changes to the tax laws or changes in other laws (includingunder applicable income tax treaties), regulations, rules, or interpretations thereof applicable to inverted companies and their affiliates, whether enactedbefore or after the EPD Business Acquisition, may materially adversely affect us.Under current U.S. law, we believe that we should not be treated as a U.S. corporation for U.S. federal income tax purposes as a result of Mylan’sacquisition of Mylan Inc. and the EPD Business (the “EPD Business Acquisition”). Changes to Section 7874 of the U.S. Internal Revenue Code of 1986, asamended (the “Code”), or to the U.S. Treasury Regulations promulgated thereunder, or interpretations thereof, or to other relevant tax laws (includingapplicable income tax treaties), could affect our status as a non-U.S. corporation for U.S. federal income tax purposes and the tax consequences to us and ouraffiliates. Any such changes could have prospective or retroactive application, and may apply even if enacted or promulgated now that the EPD BusinessAcquisition has closed.If we were to be treated as a U.S. corporation for U.S. federal income tax purposes, or if the relevant tax laws (including applicable income taxtreaties) change, we would be subject to significantly greater U.S. tax liability than currently contemplated as a non-U.S. corporation or if the relevant taxlaws (including applicable income tax treaties) had not changed, which would have a material adverse effect on our business, financial condition, results ofoperations, cash flows, and/or ordinary share price.33Table of ContentsThe IRS may not agree that we should be treated as a non-U.S. corporation for U.S. federal income tax purposes.The IRS may not agree that we should be treated as a non-U.S. corporation for U.S. federal income tax purposes. Although we are not incorporated inthe U.S. and expect to be treated as a non-U.S. corporation for U.S. federal income tax purposes, the IRS may assert that we should be treated as a U.S.corporation for U.S. federal income tax purposes. As disclosed in the tax footnote to our financial statements, we have received and responded to various IRSrequests for information about the EPD Business Acquisition and our status as a non-U.S. corporation for U.S. federal income tax purposes. If we were to betreated as a U.S. corporation for U.S. federal income tax purposes, we would be subject to significantly greater U.S. tax liability, beginning February 27, 2015,than currently contemplated as a non-U.S. corporation, which would have a material adverse effect on our business, financial condition, results of operations,cash flows, and/or ordinary share price.If the intercompany terms of cross border arrangements that we have among our subsidiaries are determined to be inappropriate or ineffective, our taxliability may increase.We have potential tax exposures resulting from the varying application of statutes, regulations, and interpretations which include exposures onintercompany terms of cross-border arrangements among our subsidiaries (including intercompany loans, sales, and services agreements) in relation tovarious aspects of our business, including manufacturing, marketing, sales, and delivery functions. Although we believe our cross-border arrangementsamong our subsidiaries are based upon internationally accepted standards and applicable law, tax authorities in various jurisdictions may disagree with andsubsequently challenge the amount of profits taxed in their country, which may result in increased tax liability, including accrued interest and penalties,which would cause our tax expense to increase and could have a material adverse effect on our business, financial condition, results of operations, cash flows,and/or ordinary share price.We may not be able to maintain competitive financial flexibility and our corporate tax rate and could adversely affect us and our shareholders.We believe that our structure and operations give us the ability to achieve competitive financial flexibility and a competitive worldwide effectivecorporate tax rate. The material assumptions underlying our expected tax rates include the fact that we expect certain of our businesses will be operatedoutside of the U.S. and, as such, will be subject to a lower tax rate than operations in the U.S., which will result in a lower blended worldwide tax rate than wewere previously able to achieve. We must also make assumptions regarding the effect of certain internal reorganization transactions, including variousintercompany transactions. We cannot give any assurance as to what our effective tax rate will be, however, because of, among other reasons, uncertaintyregarding the tax policies of the jurisdictions where we operate, potential changes of laws and interpretations thereof, and the potential for tax audits orchallenges. Our actual effective tax rate may vary from our expectation and that variance may be material. Additionally, the tax laws of the U.K., theNetherlands and other jurisdictions could change in the future, and such changes could cause a material change in our effective tax rate.Any of the factors discussed above could materially increase our overall effective income tax rate and income tax expense and could have a materialadverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.Unanticipated changes in our tax provisions or exposure to additional income tax liabilities and changes in income tax laws and tax rulings may have asignificant adverse impact on our effective tax rate and income tax expense.We are subject to income taxes in many jurisdictions. Significant analysis and judgment are required in determining our worldwide provision forincome taxes. In the ordinary course of business, there are many transactions and calculations where the ultimate tax determination is uncertain. The finaldetermination of any tax audits or related litigation could be materially different from our income tax provisions and accruals.Additionally, changes in the effective tax rate as a result of a change in the mix of earnings in countries with differing statutory tax rates, changes inour overall profitability, changes in the valuation of deferred tax assets and liabilities, the results of audits and the examination of previously filed tax returnsby taxing authorities, and continuing assessments of our tax exposures could impact our tax liabilities and affect our income tax expense, which could have amaterial adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.We may become taxable in a jurisdiction other than the U.K. and this may increase the aggregate tax burden on us.Based on our current management structure and current tax laws of the U.S., the U.K., and the Netherlands, as well as applicable income tax treaties,and current interpretations thereof, the U.K. and the Netherlands competent authorities have34Table of Contentsdetermined that we are tax resident solely in the U.K. for the purposes of the Netherlands-U.K. tax treaty. We have received a binding ruling from thecompetent authorities in the U.K. and in the Netherlands confirming this treatment. We will therefore be tax resident solely in the U.K. so long as the facts andcircumstances set forth in the relevant application letters sent to those authorities remain accurate. Even though we received a binding ruling, the applicabletax laws or interpretations thereof may change, or the assumptions on which such rulings were based may differ from the facts. As a consequence, we maybecome a tax resident of a jurisdiction other than the U.K. As a consequence, our overall effective income tax rate and income tax expense could materiallyincrease, which could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.We have a number of clean energy investments which are subject to various risks and uncertainties.We have invested in clean energy operations capable of producing refined coal that we believe qualify for tax credits under Section 45 of the Code.Our ability to claim tax credits under Section 45 of the Code depends upon the operations in which we have invested satisfying certain ongoing conditionsset forth in Section 45 of the Code. These include, among others, the emissions reduction, “qualifying technology”, and “placed-in-service” requirements ofSection 45 of the Code, as well as the requirement that at least one of the operations’ owners qualifies as a “producer” of refined coal. While we have receivedsome degree of confirmation from the IRS relating to our ability to claim these tax credits, the IRS could ultimately determine that the operations have notsatisfied, or have not continued to satisfy, the conditions set forth in Section 45 of the Code.In addition, Congress could modify or repeal Section 45 of the Code and remove the tax credits retroactively. In addition, Section 45 of the Codecontains phase out provisions based upon the market price of coal, such that, if the price of coal rises to specified levels, we could lose some or all of the taxcredits we expect to receive from these investments. Finally, when the price of natural gas or oil declines relative to that of coal, some utilities may choose toburn natural gas or oil instead of coal. Market demand for coal may also decline as a result of an economic slowdown and a corresponding decline in the useof electricity. If utilities burn less coal, eliminate coal in the production of electricity or are otherwise unable to operate for an extended period of time, theavailability of the tax credits would also be reduced. During 2017 and 2018, as a result of a decline in current and expected future production levels at certainof our clean energy facilities, the Company impaired its investment balance and other assets and in 2018 we terminated certain of our clean energyinvestments. Additional impairments or terminations could occur in the future.The occurrence of any of the above risks could limit the value of our investment, result in increased costs, materially increase our tax burden oradversely affect our business, financial condition, results of operations, cash flows, and/or ordinary share price.Currency fluctuations and changes in exchange rates could adversely affect our business, financial condition, results of operations, cash flows, and/orordinary share price.Although we report our financial results in U.S. Dollars, a significant portion of our revenues, indebtedness and other liabilities and our costs aredenominated in non-U.S. currencies, including among others the Euro, Swedish Krona, Indian Rupee, Japanese Yen, Australian Dollar, Canadian Dollar,British Pound Sterling and Brazilian Real. Our results of operations and, in some cases, cash flows, have in the past been and may in the future be adverselyaffected by certain movements in currency exchange rates. Defaults or restructurings in other countries could have a similar adverse impact. From time totime, we may implement currency hedges intended to reduce our exposure to changes in foreign currency exchange rates. However, our hedging strategiesmay not be successful, and any of our unhedged foreign exchange exposures will continue to be subject to market fluctuations. The occurrence of any of theabove risks could cause a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share priceWe have significant indebtedness, which could lead to adverse consequences or adversely affect our financial position and prevent us from fulfilling ourobligations under such indebtedness, and any refinancing of this debt could be at significantly higher interest rates.Our level of indebtedness could have important consequences, including but not limited to:•increasing our vulnerability to general adverse economic and industry conditions;•requiring us to dedicate a substantial portion of our cash flow from operations to make debt service payments, thereby reducing the availability ofcash flow to fund working capital, capital expenditures, acquisitions and investments and other general corporate purposes;35Table of Contents•limiting our flexibility in planning for, or reacting to, challenges and opportunities, and changes in our businesses and the markets in which weoperate;•limiting our ability to obtain additional financing to fund our working capital, capital expenditures, acquisitions and debt service requirements andother financing needs;•increasing our vulnerability to increases in interest rates in general because a substantial portion of our indebtedness bears interest at floating rates;and•placing us at a competitive disadvantage to our competitors that have less debt.Our ability to service our indebtedness will depend on our future operating performance and financial results, which will be subject, in part, tofactors beyond our control, including interest rates and general economic, financial and business conditions. If we do not have sufficient cash flow to serviceour indebtedness, we may need to refinance all or part of our existing indebtedness, borrow more money or sell securities or assets, some or all of which maynot be available to us at acceptable terms or at all. In addition, we may need to incur additional indebtedness in the future in the ordinary course of business.Although the terms of our credit agreements and our bond indentures allow us to incur additional debt, this is subject to certain limitations which maypreclude us from incurring the amount of indebtedness we otherwise desire.In addition, although Mylan expects to maintain an investment grade credit rating, a downgrade in the credit rating of Mylan or any indebtedness ofMylan or its subsidiaries could increase the cost of further borrowings or refinancings of such indebtedness, limit access to sources of financing in the futureor lead to other adverse consequences.In addition, if we incur additional debt, the risks described above could intensify. If global credit markets contract, future debt financing may not beavailable to us when required or may not be available on acceptable terms or at all, and as a result we may be unable to grow our business, take advantage ofbusiness opportunities, respond to competitive pressures or satisfy our obligations under our indebtedness. Any of the foregoing could have a materialadverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary share price.Our credit facilities, senior unsecured notes, commercial paper program, other outstanding indebtedness and any additional indebtedness we incur inthe future impose, or may impose, significant operating and financial restrictions on us. These restrictions limit our ability to, among other things, incuradditional indebtedness, make investments, pay certain dividends, prepay other indebtedness, sell assets, incur certain liens, enter into agreements with ouraffiliates or restricting our subsidiaries’ ability to pay dividends, merge or consolidate. In addition, our credit facilities require us to maintain specifiedfinancial ratios. A breach of any of these covenants or our inability to maintain the required financial ratios could result in a default under the relatedindebtedness. If a default occurs, the relevant lenders could elect to declare our indebtedness, together with accrued interest and other fees, to be immediatelydue and payable. These factors could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinaryshare price.There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with U.S.GAAP. Any future changes in estimates, judgments and assumptions used or necessary revisions to prior estimates, judgments or assumptions or changes inaccounting standards could lead to a restatement or revision to previously issued financial statements.The Consolidated and Condensed Consolidated Financial Statements included in the periodic reports we file with the SEC are prepared inaccordance with U.S. GAAP. The preparation of financial statements in accordance with U.S. GAAP involves making estimates, judgments and assumptionsthat affect reported amounts of assets, liabilities, revenues, expenses and income. Estimates, judgments and assumptions are inherently subject to change inthe future and any necessary revisions to prior estimates, judgments or assumptions could lead to a restatement. Furthermore, although we have recordedreserves for litigation related contingencies based on estimates of probable future costs, such litigation related contingencies could result in substantialfurther costs. Also, any new or revised accounting standards may require adjustments to previously issued financial statements. Any such changes couldresult in corresponding changes to the amounts of liabilities, revenues, expenses and income.On August 17, 2017, the Company announced that its subsidiaries, Mylan Inc. and Mylan Specialty L.P., signed an agreement with the U.S.Department of Justice ("DOJ") and two relators finalizing the $465 million settlement, plus interest, with the DOJ and other government agencies related tothe classification of the EpiPen® Auto-Injector for purposes of the Medicaid Drug Rebate Program that Mylan had agreed to the terms of on October 7, 2016(the “Medicaid Drug Rebate Program Settlement”). On April 25, 2017, Mylan received a comment letter from the staff of the SEC’s Division of CorporationFinance with respect to Mylan’s Annual Report on Form 10-K for the year ended December 31, 2016, requesting information regarding Mylan’s accountingtreatment of the $465 million Medicaid Drug Rebate Program Settlement with the DOJ, including with respect to the determinations36Table of Contentsthat the settlement amount should be recorded as a charge against earnings in the third quarter of 2016 rather than against any earlier periods, and that thesettlement amount should be classified as an expense rather than a reduction of revenue.Any of the changes discussed above could have a material adverse effect on our business, financial condition, results of operations, cash flows,and/or ordinary share price.We must maintain adequate internal controls and be able to provide an assertion as to the effectiveness of such controls on an annual basis.Effective internal controls are necessary for us to provide reasonable assurance with respect to our financial reports. We spend a substantial amountof management and other employee time and resources to comply with laws, regulations and standards relating to corporate governance and publicdisclosure. In the U.S., such regulations include the Sarbanes-Oxley Act of 2002, SEC regulations and the NASDAQ listing standards. In particular, Section404 of the Sarbanes-Oxley Act of 2002 requires management’s annual review and evaluation of our internal control over financial reporting and attestation asto the effectiveness of these controls by our independent registered public accounting firm. If we fail to maintain the adequacy of our internal controls, wemay not be able to ensure that we can conclude on an ongoing basis that we have effective internal control over financial reporting. Additionally, internalcontrol over financial reporting may not prevent or detect misstatements because of its inherent limitations, including the possibility of human error, thecircumvention or overriding of controls, or fraud. Therefore, even effective internal controls can provide only reasonable assurance with respect to thepreparation and fair presentation of financial statements. In addition, projections of any evaluation of effectiveness of internal control over financialreporting to future periods are subject to the risk that the control may become inadequate because of changes in conditions, or that the degree of compliancewith the policies or procedures may deteriorate. If we fail to maintain the adequacy of our internal controls, including any failure to implement required newor improved controls, this could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinary shareprice.Our actual financial position and results of operations may differ materially from the unaudited pro forma financial information included in this annualreport.The unaudited pro forma financial information contained in this Annual Report on Form 10-K may not be indicative of what our financial positionor results of operations would have been had the Meda transaction been completed on the dates indicated, nor are they indicative of the future operatingresults of Mylan N.V. The unaudited pro forma financial information has been derived from the historical consolidated financial statements of Mylan N.V.,Mylan Inc., and Meda and reflects certain adjustments related to past operating performance and acquisition accounting adjustments, such as increasedamortization expense based on the fair value of assets acquired, the impact of transaction costs, and the related income tax effects. The information uponwhich these adjustments have been made is subjective, and these types of adjustments are difficult to make with complete accuracy. Accordingly, the actualfinancial position and results of our operations following the Meda transaction may not be consistent with, or evident from, this unaudited pro formafinancial information and other factors may affect our business, financial condition, results of operations, cash flows, and/or ordinary share price, including,among others, those described herein.ITEM 1B.Unresolved Staff CommentsAs previously disclosed, on April 25, 2017, Mylan received a comment letter from the staff of the SEC’s Division of Corporation Finance with respectto Mylan’s Annual Report on Form 10-K for the year ended December 31, 2016, requesting information regarding Mylan’s accounting treatment of the $465million Medicaid Drug Rebate Program Settlement with the DOJ, including with respect to the determinations that the settlement amount should be recordedas a charge against earnings in the third quarter of 2016 rather than against any earlier periods, and that the settlement amount should be classified as anexpense rather than a reduction of revenue. The Company responded to the comment letter in May 2017 and we will continue to respond to any additionalcorrespondence from the SEC’s Division of Corporation Finance. We believe that our accounting treatment for the aforementioned DOJ settlement isappropriate and consistent with all applicable accounting standards.ITEM 2.PropertiesFor information regarding properties, refer to Item 1 “Business” in Part I of this Annual Report on Form 10-K.ITEM 3.Legal ProceedingsFor information regarding legal proceedings, refer to Note 19 Litigation included in Item 8 in this Annual Report on Form 10-K.37Table of ContentsPART IIITEM 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity SecuritiesOur ordinary shares are traded on the NASDAQ Stock Market under the symbol “MYL”. Our ordinary shares were also traded on the Tel Aviv StockExchange (“TASE”). On November 10, 2017, however, the Company announced that it was voluntarily delisting the Company's ordinary shares from tradingon the TASE and the TASE delisting became effective on February 12, 2018.As of January 23, 2019, there were approximately 128,000 holders of Mylan N.V. ordinary shares, including those held in street or nominee name.The Company did not pay dividends in 2018 or 2017 and does not intend to pay dividends on its ordinary shares in the near future.UNREGISTERED SALES OF DEBT SECURITIESIn the past three years, we have issued unregistered securities in connection with the following transactions:In May 2018, Mylan Inc. issued €500 million aggregate principal amount of senior unsecured debt securities, comprised of 2.125% Euro SeniorNotes due 2025. These notes were issued in a private offering exempt from the registration requirements of the Securities Act of 1933, as amended (the“Securities Act”), to persons outside of the U.S. pursuant to Regulation S under the Securities Act.In April 2018, Mylan Inc. issued $1.5 billion aggregate principal amount of senior unsecured debt securities, comprised of 4.550% Senior Notes due2028 and 5.200% Senior Notes due 2048. These notes were issued in a private offering exempt from the registration requirements of the Securities Act, toqualified institutional buyers in accordance with Rule 144A under the Securities Act and to persons outside of the U.S. pursuant to Regulation S under theSecurities Act. In November 2018, Mylan N.V. and Mylan Inc. filed a registration statement with the SEC with respect to an offer to exchange these notes forregistered notes with the same aggregate principal amount and terms substantially identical in all material respects, which was declared effective onDecember 11, 2018. The exchange offer expired on January 9, 2019 and settled on January 10, 2019. 100% of each of the 4.550% Senior Notes due 2028 andthe 5.200% Senior Notes due 2048 were exchanged. In May 2017, Mylan N.V. issued €500 million aggregate principal amount of senior unsecured debt securities, comprised of floating rate SeniorNotes due 2020. These notes were issued in a private offering exempt from the registration requirements of the Securities Act, to persons outside of the U.S.pursuant to Regulation S under the Securities Act.In November 2016, Mylan N.V. issued €3.0 billion aggregate principal amount of senior unsecured debt securities, comprised of floating rate SeniorNotes due 2018, 1.250% Senior Notes due 2020, 2.250% Senior Notes due 2024 and 3.125% Senior Notes due 2028. These notes were issued in a privateoffering exempt from the registration requirements of the Securities Act, to persons outside of the U.S. pursuant to Regulation S under the Securities Act.In June 2016, Mylan N.V. issued $6.5 billion aggregate principal amount of senior unsecured debt securities, comprised of 2.500% Senior Notes due2019, 3.150% Senior Notes due 2021, 3.950% Senior Notes due 2026 and 5.250% Senior Notes due 2046. These notes were issued in a private offeringexempt from the registration requirements of the Securities Act, to qualified institutional buyers in accordance with Rule 144A under the Securities Act andto persons outside of the U.S. pursuant to Regulation S under the Securities Act. In December 2016, Mylan N.V. and Mylan Inc. filed a registration statementwith the SEC with respect to an offer to exchange these notes for registered notes with the same aggregate principal amount and terms substantially identicalin all material respects, which was declared effective on January 3, 2017. The exchange offer expired on January 31, 2017 and settled on February 3, 2017.38Table of ContentsSTOCK PERFORMANCE GRAPHSet forth below is a performance graph comparing the cumulative total return (assuming reinvestment of dividends), in U.S. Dollars, for the calendaryears ended December 31, 2014, 2015, 2016, 2017 and 2018 of $100 invested on December 31, 2013 in the Company’s ordinary shares, the Standard &Poor’s 500 Index and the Dow Jones U.S. Pharmaceuticals Index. December 31, 2013 December 31, 2014 December 31, 2015 December 31, 2016 December 31, 2017 December 31, 2018Mylan N.V. (1)100.00 129.88 124.59 87.90 97.49 63.13S&P 500100.00 113.69 115.26 129.05 157.22 150.33Dow Jones U.S. Pharmaceuticals100.00 121.41 128.94 126.14 141.33 153.17____________(1) Mylan Inc. prior to February 27, 2015.39Table of ContentsITEM 6.Selected Financial DataThe selected consolidated financial data set forth below should be read in conjunction with “Management’s Discussion and Analysis of Results ofOperations and Financial Condition” included in Item 7 and the Consolidated Financial Statements and related Notes to Consolidated Financial Statementsincluded in Item 8 in this Annual Report on Form 10-K. The functional currency of the primary economic environment in which the operations of Mylan andits subsidiaries in the U.S. are conducted is the U.S. Dollar. The functional currency of non-U.S. subsidiaries is generally the local currency in the country inwhich each subsidiary operates.Mylan N.V. is the successor to Mylan Inc., the information set forth below refers to Mylan Inc. for periods prior to February 27, 2015, and to MylanN.V. on and after February 27, 2015. Year Ended December 31,(In millions, except per share amounts)2018 2017 2016 2015 2014Statements of Operations: Total revenues$11,433.9 $11,907.7 $11,076.9 $9,429.3 $7,719.6Cost of sales (1)7,432.3 7,124.6 6,379.9 5,213.2 4,191.6Gross profit4,001.6 4,783.1 4,697.0 4,216.1 3,528.0Operating expenses: Research and development704.5 783.3 826.8 671.9 581.8Selling, general and administrative2,441.0 2,575.7 2,498.5 2,180.7 1,625.7Litigation settlements and other contingencies, net(49.5) (13.1) 672.5 (97.4) (32.1)Total operating expenses3,096.0 3,345.9 3,997.8 2,755.2 2,175.4Earnings from operations905.6 1,437.2 699.2 1,460.9 1,352.6Interest expense542.3 534.6 454.8 339.4 333.2Other expense, net64.9 (0.4) 122.7 206.1 44.9Earnings before income taxes298.4 903.0 121.7 915.4 974.5Income tax (benefit) provision(54.1) 207.0 (358.3) 67.7 41.4Net loss attributable to the noncontrolling interest— — — (0.1) (3.7)Net earnings attributable to Mylan N.V. ordinaryshareholders$352.5 $696.0 $480.0 $847.6 $929.4Earnings per ordinary share attributable to Mylan N.V.ordinary shareholders Basic$0.69 $1.30 $0.94 $1.80 $2.49Diluted$0.68 $1.30 $0.92 $1.70 $2.34Weighted average ordinary shares outstanding: Basic514.5 534.5 513.0 472.2 373.7Diluted516.5 536.7 520.5 497.4 398.0Selected Balance Sheet data: Total assets (2)(3)$32,734.9 $35,806.3 $34,726.2 $22,267.7 $15,820.5Working capital (2)(3)(4)1,779.9 828.0 2,481.8 2,350.5 1,137.2Short-term borrowings1.9 46.5 46.4 1.3 330.7Long-term debt, including current portion of long-term debt (2)13,816.4 14,614.5 15,426.2 7,294.3 8,104.1Total equity12,167.1 13,307.6 11,117.6 9,765.8 3,276.0____________(1) Cost of sales includes the following amounts primarily related to the amortization of purchased intangibles from acquisitions: $1.61 billion, $1.44billion, $1.32 billion, $854.2 million and $375.9 million for the years ended December 31, 2018, 2017, 2016, 2015 and 2014, respectively. Inaddition, cost of sales included the following amounts40Table of Contentsrelated to impairment charges to intangible assets: $224.0 million, $80.8 million, $68.3 million, $31.3 million and $27.7 million for the years endedDecember 31, 2018, 2017, 2016, 2015 and 2014, respectively.(2) Pursuant to the Company’s adoption of Accounting Standards Update 2015-03, Interest - Imputation of Interest, as of December 31, 2015, deferredfinancing fees related to term debt have been retrospectively reclassified from other assets to long-term debt or the current portion of long-term debt,depending on the debt instrument, on the Consolidated Balance Sheets for all periods presented. The Company retrospectively reclassifiedapproximately $34.4 million for the year ended December 31, 2014.(3) Pursuant to the Company’s adoption of Accounting Standards Update 2015-17, Balance Sheet Classification of Deferred Taxes, as of December 31,2015, deferred tax assets and liabilities that had been previously classified as current have been retrospectively reclassified to noncurrent on theConsolidated Balance Sheets for all periods presented. The reclassification resulted in a decrease in current assets of approximately $345.7 millionfor the year ended December 31, 2014. The reclassification resulted in a decrease in current liabilities of approximately $0.2 million for the yearended December 31, 2014.(4) Working capital is calculated as current assets minus current liabilities.41Table of ContentsITEM 7.Management’s Discussion and Analysis of Financial Condition And Results of OperationsThe following discussion and analysis addresses material changes in the financial condition and results of operations of Mylan N.V. and subsidiariesfor the periods presented. Unless context requires otherwise, the “Company,” “Mylan,” “our” or “we” refer to Mylan N.V. and its subsidiaries.This discussion and analysis should be read in conjunction with the Consolidated Financial Statements and the related Notes to ConsolidatedFinancial Statements included in Item 8 in this Annual Report on Form 10-K, and our other SEC filings and public disclosures.This Annual Report on Form 10-K contains “forward-looking statements.” These statements are made pursuant to the safe harbor provisions of thePrivate Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about Mylan’s futureoperations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition, and otherexpectations and targets for future periods. These may often be identified by the use of words such as “will,” “may,” “could,” “should,” “would,” “project,”“believe,” “anticipate,” “expect,” “plan,” “estimate,” “forecast,” “potential,” “pipeline,” “intend,” “continue,” “target,” “seek” and variations of these wordsor comparable words.Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed orimplied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to:•actions and decisions of healthcare and pharmaceutical regulators;•failure to achieve expected or targeted future financial and operating performance and results;•uncertainties regarding future demand, pricing and reimbursement for our products;•any regulatory, legal or other impediments to Mylan’s ability to bring new products to market, including, but not limited to, where Mylan uses itsbusiness judgment and decides to manufacture, market and/or sell products, directly or through third parties, notwithstanding the fact thatallegations of patent infringement(s) have not been finally resolved by the courts (i.e., an “at-risk launch”);•success of clinical trials and Mylan’s ability to execute on new product opportunities;•any changes in or difficulties with our manufacturing facilities, including with respect to our remediation and restructuring activities, supply chainor inventory or our ability to meet anticipated demand;•the scope, timing and outcome of any ongoing legal proceedings, including government investigations, and the impact of any such proceedings onour financial condition, results of operations and/or cash flows;•the ability to meet expectations regarding the accounting and tax treatments of acquisitions, including Mylan’s acquisition of Mylan Inc. and EPDBusiness;•changes in relevant tax and other laws, including but not limited to changes in the U.S. tax code and healthcare and pharmaceutical laws andregulations in the U.S. and abroad;•any significant breach of data security or data privacy or disruptions to our IT systems;•the ability to protect intellectual property and preserve intellectual property rights;•the effect of any changes in customer and supplier relationships and customer purchasing patterns;•the ability to attract and retain key personnel;•the impact of competition;•identifying, acquiring and integrating complementary or strategic acquisitions of other companies, products or assets being more difficult, time-consuming or costly than anticipated;•the possibility that Mylan may be unable to achieve expected synergies and operating efficiencies in connection with strategic acquisitions,strategic initiatives or restructuring programs within the expected time-frames or at all;•uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions and globalexchange rates; and•inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates offinancial measures, in accordance with U.S. GAAP and related standards or on an adjusted basis.42Table of ContentsFor more detailed information on the risks and uncertainties associated with Mylan’s business activities, see the risks described in Item 1A in thisAnnual Report on Form 10-K for the year ended December 31, 2018, and our other filings with the SEC.You can access Mylan’s filings with the SEC through the SEC website at www.sec.gov or through our website, and Mylan strongly encourages youto do so. Mylan routinely posts information that may be important to investors on our website at investor.mylan.com, and we use this website address as ameans of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC’s Regulation Fair Disclosure (Reg FD).The contents of our website are not incorporated by reference in this Annual Report on Form 10-K and shall not be deemed “filed” under theExchange Act, as amended.Mylan undertakes no obligation to update any statements herein for revisions or changes after the filing date of this Annual Report on Form 10-K.Company OverviewMylan is a global pharmaceutical company committed to setting new standards in healthcare and providing 7 billion people access to high qualitymedicine. We offer a growing portfolio of more than 7,500 products, including prescription generic, branded generic, brand-name drugs and OTC remedies.We market our products in more than 165 countries and territories. Every member of our approximately 35,000-strong global workforce is dedicated todelivering better health for a better world.Over the last several years, Mylan has transformed itself through a clear, consistent and differentiated strategy into a company that is built to last.Fueling that durability is a business model anchored in providing access, Mylan’s core purpose.Providing access requires that we satisfy the needs of an incredibly diverse global marketplace whose economic and political systems, approaches todelivering and paying for healthcare, languages and traditions, and customer and patient requirements vary by location and over time.With these considerations in mind, we built and scaled our commercial, operational and scientific platforms to meet customers’ evolving needs inways that are globally consistent and locally sensitive. As a result, not only are we succeeding in expanding people’s access to medicine, we are continuallydiversifying our business.That diversification is what drives our durability. Durability allows us to withstand and overcome competitive pressures while continuing toinnovate. It also allows us to generate consistent financial results, including reliable cash flows capable of supporting ongoing investments in long-termgrowth.Certain Market and Industry FactorsThe global pharmaceutical industry is a highly competitive and highly regulated industry. As a result, we face a number of industry-specific factorsand challenges, which can significantly impact our results. The following discussion highlights some of these key factors and market conditions.Generic products, particularly in the U.S., generally contribute most significantly to revenues and gross margins at the time of their launch, and evenmore so in periods of market exclusivity, or in periods of limited generic competition. As such, the timing of new product introductions can have a significantimpact on the Company’s financial results. The entrance into the market of additional competition generally has a negative impact on the volume andpricing of the affected products. Additionally, pricing is often affected by factors outside of the Company’s control.For branded products, the majority of the product’s commercial value is usually realized during the period in which the product has marketexclusivity. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there canoften be very substantial and rapid declines in the branded product’s sales. OTC products also participate in a competitive environment that includes bothbranded and private label products. In the OTC space, value is realized through innovation, access and consumer activation.Certain markets in which we do business outside of the U.S. have undergone government-imposed price reductions, and further government-imposedprice reductions are expected in the future. Such measures, along with the tender systems discussed below, are likely to have a negative impact on sales andgross profit in these markets. However, government43Table of Contentsinitiatives in certain markets that appear to favor generic products could help to mitigate this unfavorable effect by increasing rates of generic substitutionand penetration.Additionally, a number of markets in which we operate outside of the U.S. have implemented, or may implement, tender systems for genericpharmaceuticals in an effort to lower prices. Generally speaking, tender systems can have an unfavorable impact on sales and profitability. Under such tendersystems, manufacturers submit bids that establish prices for generic pharmaceutical products. Upon winning the tender, the winning company will receivepriority placement for a period of time. The tender system often results in companies underbidding one another by proposing low pricing in order to win thetender. The loss of a tender by a third party to whom we supply API can also have a negative impact on our sales and profitability. Sales continue to benegatively affected by the impact of tender systems in certain countries.Recent DevelopmentsIn the fourth quarter of 2016, the Company announced a restructuring program representing initial steps of a series of actions in certain locationsthat are anticipated to further streamline our operations globally. During the year ended December 31, 2018, the Company recorded pre-tax restructuringcharges of $240.2 million. Included within the restructuring charges during the year ended December 31, 2018 were $144.5 million for non-cash assetimpairment charges. The remaining restructuring charges during the year ended December 31, 2018 primarily related to severance and employee benefits.The restructuring program, other than the additional restructuring and remediation activities at the Morgantown, West Virginia plant described below, wassubstantially complete as of December 31, 2018. As a result of the overall actions taken under the restructuring program through December 31, 2018,management believes the potential annual savings will be between approximately $400.0 million and $475.0 million once fully realized, with the majorityof these savings improving operating cash flow.In April 2018, the FDA completed an inspection at Mylan’s plant in Morgantown, West Virginia and made observations through a Form 483. TheCompany submitted a comprehensive response to the FDA and committed to a robust improvement plan. In addition, based upon the Company’s recognitionof the continued evolution of industry dynamics and regulatory expectations, during the second quarter of 2018, the Company commenced comprehensiverestructuring and remediation activities, which are aimed at reducing complexity at the Morgantown plant and include the discontinuation and transfer toother manufacturing sites of a number of products, a reduction of the workforce and extensive process and plant remediation. In the fourth quarter of 2018,the Company received a warning letter related to the previously disclosed observations at the plant. The issues raised in the warning letter are beingaddressed within the context of the Company’s comprehensive restructuring and remediation activities.The Morgantown plant continues to supply products for the U.S. market while we execute on and assess the restructuring and remediation activities.However, these activities have led to a temporary disruption in supply of certain products. Importantly, the profitability of the transferred and discontinuedproducts is not proportionate to the reduced volumes of those products as the Company expects that manufacturing costs related to transferred products willbe reduced and many of the discontinued products have lower than average gross margins. In addition, as it relates to North America, no significant newproduct revenue is forecasted from the Morgantown plant in 2019, and we are forecasting that only five of our top 50 and only one out of the top 10 grossmargin generating products will be manufactured in Morgantown in 2019.For the year ended December 31, 2018, the Company has incurred expenses amounting to approximately $258.3 million for incrementalmanufacturing variances, site remediation and restructuring charges related to the Morgantown plant. At this time, the total expenses related to the additionalrestructuring and remediation activities at the Morgantown plant cannot be reasonably estimated.Mylan remains committed to maintaining the highest quality manufacturing standards at its facilities around the world and to continuousassessment and improvement in a time of evolving industry dynamics and regulatory expectations.In April 2018, the State of New York passed a budget which included the Opioid Stewardship Fund (the “Fund”). The Fund created anaggregate $100 million annual assessment on all manufacturers and distributors licensed to sell or distribute opioids in New York. In December 2018 afederal judge struck down the law ruling that the law was an unconstitutional regulatory penalty. New York has appealed the ruling.On January 30, 2019, the Company received FDA approval of WixelaTM InhubTM (fluticasone propionate and salmeterol inhalation powder, USP),the first generic of GlaxoSmithKline’s Advair Diskus®. The commercial launch of the Wixela Inhub occurred in February 2019.44Table of ContentsFinancial SummaryThe table below is a summary of the Company’s financial results for the year ended December 31, 2018 compared to the prior year period: Year Ended December 31, (In millions, except per share amounts)2018 2017 Change % ChangeTotal revenues$11,433.9 $11,907.7 $(473.8) (4)%Gross profit4,001.6 4,783.1 (781.5) (16)%Earnings from operations905.6 1,437.2 (531.6) (37)%Net earnings352.5 696.0 (343.5) (49)%Diluted earnings per ordinary share$0.68 $1.30 $(0.62) (47)%A detailed discussion of the Company’s financial results can be found below in the section titled “Results of Operations.” As part of this discussion,we also report sales performance using the non-GAAP financial measures of “constant currency” net sales and total revenues. These measures providesinformation on the change in net sales and total revenues assuming that foreign currency exchange rates had not changed between the prior and currentperiod. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year’s foreign exchange rates. We routinelyevaluate our net sales and total revenues performance at constant currency so that sales results can be viewed without the impact of foreign currencyexchange rates, thereby facilitating a period-to-period comparison of our operational activities, and believe that this presentation also provides usefulinformation to investors for the same reason.More information about non-GAAP measures used by the Company as part of this discussion, including adjusted cost of sales, adjusted grossmargins, adjusted net earnings, and adjusted EPS (all of which are defined below), are discussed further in this Item 7 under Results of Operations and Resultsof Operations — Use of Non-GAAP Financial Measures.Results of Operations2018 Compared to 2017 Year Ended December 31,(In millions)2018 2017 % Change 2018 CurrencyImpact (1) 2018 ConstantCurrencyRevenues Constant Currency% Change (2)Net sales North America$4,095.6 $4,969.6 (18)% $(0.8) $4,094.8 (18)%Europe4,157.3 3,958.3 5 % (144.5) 4,012.8 1 %Rest of World3,015.8 2,832.1 7 % 88.6 3,104.4 10 %Total net sales11,268.7 11,760.0 (4)% (56.7) 11,212.0 (5)% Other revenues (3)165.2 147.7 12 % (2.0) 163.2 10 %Consolidated total revenues (4)$11,433.9 $11,907.7 (4)% $(58.7) $11,375.2 (4)%____________(1) Currency impact is shown as unfavorable (favorable).(2) The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative periodexchange rates, and in doing so shows the percentage change from 2018 constant currency net sales or revenues to the corresponding amount in theprior year.(3) For the year ended December 31, 2018, other revenues in North America, Europe, and Rest of World were approximately $112.4 million, $27.1million, and $25.7 million, respectively.(4) Amounts exclude intersegment revenue that eliminates on a consolidated basis.45Table of ContentsTotal RevenuesFor the year ended December 31, 2018, Mylan reported total revenues of $11.43 billion, compared to $11.91 billion for the comparable prior yearperiod, representing a decrease of $473.8 million, or 4%. Total revenues include both net sales and other revenues from third parties. Net sales for the yearended December 31, 2018 were $11.27 billion, compared to $11.76 billion for the comparable prior year period, representing a decrease of $491.3 million, or4%. Other revenues for the year ended December 31, 2018 were $165.2 million, compared to $147.7 million for the comparable prior year period, an increaseof $17.5 million. The increase in other revenues was primarily the result of consideration received from the licensing of intellectual property during thecurrent year.The decrease in net sales included a decrease in the North America segment of 18%. This decrease was partially offset by increases in the Europesegment of 5% and in the Rest of World segment of 7%. The overall decrease in net sales was primarily driven by a decrease in net sales from existingproducts. Net sales from existing products, partially offset by new product sales, decreased on a constant currency basis by approximately $443.6 millionprimarily as a result of lower volumes, and to a lesser extent, pricing. Net sales were also negatively impacted by approximately $104.5 million due to theadoption of new accounting standards. Mylan’s net sales were favorably impacted by the effect of foreign currency translation, primarily reflecting changesin the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in the EU, which was partially offset by the unfavorable impact from changes in theIndian Rupee and the Australian Dollar. The favorable impact of foreign currency translation on current year net sales was approximately $56.7 millionresulting in a decrease in constant currency net sales of approximately $548.0 million, or 5%.From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, thisis due to the timing of new product introductions and the amount, if any, of additional competition in the market. Our top ten products in terms of net sales,in the aggregate, represented approximately 20% and 21% for the years ended December 31, 2018 and 2017, respectively.Net sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows net sales bysegment for the years ended December 31, 2018 and 2017 and the net change period over period.North America SegmentNet sales from North America decreased by $874.0 million or 18% during the year ended December 31, 2018 when compared to the prior year. Thisdecrease was due primarily to lower volumes on existing products, including the EpiPen® Auto-Injector, partially offset by new product sales. The decline involumes was primarily driven by the divestiture of certain contract manufacturing assets, the loss of exclusivity of certain products, actions associated withthe restructuring and remediation activities at the Morgantown manufacturing plant and the timing of purchases of our products by customers. In addition,net sales were negatively impacted by $149.7 million related to the implementation of new accounting standards. Pricing also declined when compared tothe prior year. The impact of foreign currency translation on current period net sales was insignificant within North America.46Table of ContentsEurope SegmentNet sales from Europe increased by $199.0 million or 5% for the year ended December 31, 2018 when compared to the prior year. This increase wasprimarily the result of the favorable impact of foreign currency translation, new product sales, and to a lesser extent, higher volumes of existing products. Thefavorable impact of foreign currency translation was approximately $144.5 million, or 4%. Partially offsetting these items was lower pricing on existingproducts. Constant currency net sales increased by approximately $54.5 million, or 1% when compared to the prior year.Rest of World SegmentNet sales from Rest of World increased by $183.7 million or 7% for the year ended December 31, 2018 when compared to the prior year. Thisincrease was primarily the result of new product sales, and to a lesser extent, higher volumes of existing products including higher sales of key brands inChina. The increase in net sales as a result of new products was primarily due to new product sales from the Company’s ARV franchise combined with newproduct sales in Australia, Japan and China. The increase in net sales was partially offset by lower pricing on existing products and the unfavorable impact offoreign currency translation. Overall, net sales from Rest of World were unfavorably impacted by the effect of foreign currency translation of approximately$88.6 million, or 3%. Constant currency net sales increased by approximately $272.3 million, or 10%.Cost of Sales and Gross ProfitCost of sales increased from $7.12 billion for the year ended December 31, 2017 to $7.43 billion for the year ended December 31, 2018. Cost of saleswas primarily impacted by purchase accounting related amortization of acquired intangible assets and other special items, which are described further in thesection titled Use of Non-GAAP Financial Measures. Gross profit for the year ended December 31, 2018 was $4.00 billion and gross margins were 35%. Forthe year ended December 31, 2017, gross profit was $4.78 billion and gross margins were 40%. Gross margins were negatively impacted by approximately270 basis points related to the incremental amortization from product acquisitions and intangible asset impairment charges. Gross margins were alsonegatively affected by approximately 220 basis points as a result of incremental manufacturing expenses, site remediation expenses and incrementalrestructuring charges incurred during the year principally as a result of the activities at the Company’s Morgantown plant. In addition, gross margins werenegatively impacted as a result of lower gross profit from the sales of existing products partially offset by gross margins on new product introductionsprimarily in North America. Adjusted gross margins were approximately 54% for the years ended December 31, 2018 and 2017. Adjusted gross margins werenegatively impacted by lower gross profit from sales of existing products partially offset by gross margins on new product introductions primarily in NorthAmerica.A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the year endedDecember 31, 2018 compared to the year ended December 31, 2017 is as follows: Year Ended December 31,(In millions)2018 2017U.S. GAAP cost of sales$7,432.3 $7,124.6Deduct: Purchase accounting amortization and other related items(1,833.3) (1,523.8)Acquisition related items(2.9) (2.8)Restructuring and related costs(118.4) (46.0)Other special items(225.1) (63.5)Adjusted cost of sales$5,252.6 $5,488.5 Adjusted gross profit (a)$6,181.3 $6,419.2 Adjusted gross margin (a)54% 54%____________(a) Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit divided bytotal revenues.47Table of ContentsOperating ExpensesResearch & Development ExpenseR&D expense for the year ended December 31, 2018 was $704.5 million, compared to $783.3 million for the prior year, a decrease of $78.8 million.This decrease was primarily due to lower expenditures related to the Company’s respiratory programs and lower expenses due to the reprioritization of globalprograms.Selling, General & Administrative ExpenseSelling, general and administrative (“SG&A”) expense for the year ended December 31, 2018 was $2.44 billion, compared to $2.58 billion for theprior year, a decrease of $134.7 million. The decrease is primarily due to the benefits of integration activities, lower restructuring charges, lower acquisition-related costs of approximately $48.0 million, and reduced share-based compensation expense primarily due to the reversal of all of the cumulative expensetotaling $70.6 million related to the Company’s One-Time Special Performance-Based Five-Year Realizable Value Incentive Program during the year endedDecember 31, 2018. These decreases were partially offset by an increase in bad debt expense of approximately $26.5 million related to a special businessinterruption event for one customer, and $20.0 million of compensation expense as an additional discretionary bonus for a certain group of employees. Noneof the employees eligible for this bonus are named executive officers.Litigation Settlements and Other Contingencies, NetDuring the year ended December 31, 2018, the Company recorded a net gain of $49.5 million for litigation settlements and other contingencies, net,compared to $13.1 million in the prior year.The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the year ended December 31,2018:(In millions)Loss/(gain)Respiratory delivery platform contingent consideration adjustment$(44.0)Jai Pharma Limited and other contingent consideration adjustments2.5Litigation settlements(8.0)Total litigation settlements and other contingencies, net$(49.5)The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the year ended December 31,2017:(In millions)Loss/(gain)Respiratory delivery platform contingent consideration adjustment$(93.5)Litigation settlements51.1Topicals Business contingent consideration adjustment23.5Jai Pharma Limited contingent consideration adjustment9.8Apicore contingent consideration adjustment(4.0)Total litigation settlements and other contingencies, net$(13.1)Interest ExpenseInterest expense for the year ended December 31, 2018 totaled $542.3 million, compared to $534.6 million for the year ended December 31, 2017,an increase of $7.7 million. The increase is due to slightly higher average interest rates on debt issued in 2018 when compared to the debt instrumentsredeemed during 2018, which was partially offset by the impact of lower average long-term balances during the year ended December 31, 2018 compared tothe prior year.48Table of ContentsOther Expense, NetOther expense, net, was $64.9 million for the year ended December 31, 2018, compared to net other income of $0.4 million for the prior year. Otherexpense (income), net includes losses from equity affiliates, foreign exchange gains and losses, and interest and dividend income. Other expense (income),net was comprised of the following for the year ended December 31, 2018 and 2017, respectively: Year Ended December 31,(In millions)2018 2017Losses from equity affiliates, primarily clean energy investments$78.7 $58.0Foreign exchange gains, net(20.0) (48.1)Other losses/(gains), net6.2 (10.3)Other expense (income), net$64.9 (0.4)Income Tax (Benefit) ProvisionFor the year ended December 31, 2018, the Company recognized an income tax benefit of $54.1 million, compared to an income tax provision of$207.0 million for the comparable prior year. During the year ended December 31, 2018, a tax benefit of $65.7 million was recorded as a result of theCompany’s settlement of certain federal and state audits. The tax provision for the year ended December 31, 2017 included a provisional net tax charge of$128.6 million related to the December 2017 U.S. Tax Cuts and Jobs Act (the “Tax Act”). Also impacting the income tax benefit for the year ended December31, 2018 versus the prior year was the changing mix of income earned in jurisdictions with differing tax rates, increases in valuation allowances on certaincarryforward tax attributes, and the revaluation of deferred tax assets and liabilities in countries that changed their statutory corporate tax rate.2017 Compared to 2016 Year Ended December 31,(In millions)2017 2016 % Change 2017 CurrencyImpact (1) 2017 ConstantCurrencyRevenues Constant Currency% Change (2)Net sales North America$4,969.6 $5,629.5 (12)% $(6.8) $4,962.8 (12)%Europe3,958.3 2,953.8 34 % (89.7) 3,868.6 31 %Rest of World2,832.1 2,383.8 19 % (52.2) 2,779.9 17 %Total net sales11,760.0 10,967.1 7 % (148.7) 11,611.3 6 % Other revenues (3)147.7 109.8 35 % (0.8) 146.9 34 %Consolidated total revenues (4)$11,907.7 $11,076.9 8 % $(149.5) $11,758.2 6 %____________(1) Currency impact is shown as unfavorable (favorable).(2) The constant currency percentage change is derived by translating net sales or revenues for the current period at prior year comparative periodexchange rates, and in doing so shows the percentage change from 2017 constant currency net sales or revenues to the corresponding amount in theprior year.(3) For the year ended December 31, 2017, other revenues in North America, Europe, and Rest of World were approximately $86.5 million, $36.5million, and $24.7 million, respectively.(4) Amounts exclude intersegment revenue that eliminates on a consolidated basis.Total RevenuesFor the year ended December 31, 2017, Mylan reported total revenues of $11.91 billion compared to $11.08 billion for the comparable prior yearperiod, representing an increase of $830.8 million, or 8%. Total revenues include both net sales and other revenues from third parties. Net sales for the yearended December 31, 2017 were $11.76 billion, compared to $10.9749Table of Contentsbillion for the comparable prior year period, representing an increase of $792.9 million, or 7%. Other revenues for the year ended December 31, 2017 were$147.7 million, compared to $109.8 million for the comparable prior year period, an increase of $37.9 million. The increase in other revenues was principallythe result of an incremental increase in royalty income from arrangements acquired in the acquisition of Meda.The increase in total revenues included net sales growth in the Europe segment of 34% and in the Rest of World segment of 19%. Net sales declinedin the North America segment by 12%. Contributing to the overall increase in total revenues were the incremental net sales from the acquisitions of Meda andthe non-sterile, topicals-focused business (the “Topicals Business”) of Renaissance Acquisition Holdings, LLC of approximately $1.41 billion. This increasewas partially offset by a net decrease in net sales from existing products and lower new product introductions of approximately $764.1 million. The decreasefrom existing products was due primarily to lower pricing and, to a lesser extent, lower volumes in 2017. Mylan’s total revenues were favorably impacted bythe effect of foreign currency translation, primarily reflecting changes in the U.S. Dollar as compared to the currencies of Mylan’s subsidiaries in theEuropean Union, India, and Australia, which was partially offset by the unfavorable impact from changes in the Japanese Yen and the Pound Sterling. Thefavorable impact of foreign currency translation on total revenues was approximately $149.5 million resulting in an increase in constant currency totalrevenues of approximately $681.3 million, or 6%.From time to time, a limited number of our products may represent a significant portion of our net sales, gross profit and net earnings. Generally, thisis due to the timing of new product introductions and the amount, if any, of additional competition in the market. Our top ten products in terms of net sales,in the aggregate, represented approximately 21% and 27% for the years ended December 31, 2017 and 2016, respectively.Net sales are derived from our three geographic reporting segments: North America, Europe and Rest of World. The graph below shows net sales bysegment for the years ended December 31, 2017 and 2016 and the net change period over period.North America SegmentNet sales from North America decreased $659.9 million, or 12% during the year ended December 31, 2017 when compared to 2016. Net sales ofexisting products decreased principally due to lower pricing and, to a lesser extent, lower volume. This was partially offset by the incremental net sales fromthe acquisitions of Meda and the Topicals Business, totaling approximately $340.0 million. For the year ended December 31, 2017, as anticipated, the U.S.generics products experienced price erosion in the high-single-digits, which includes the impact of the loss of exclusivity of armodafinil, olmesartan andolmesartan HCTZ during 2017. Sales of the EpiPen® Auto-Injector declined approximately $655.4 million from 2016 as a result of the impact of the launchof the authorized generic, higher governmental rebates as a result of the Medicaid Drug Rebate Program Settlement, and increased competition. Excludingthe negative impact of the lower sales of the EpiPen® Auto-Injector, overall third-party sales in North America were unchanged in 2017 compared with 2016.The impact of foreign currency translation on net sales was insignificant within North America.Europe SegmentNet sales from Europe increased $1.00 billion, or 34% during the year ended December 31, 2017 when compared to the prior year. This increase wasprimarily the result of net sales from the acquisition of Meda of approximately $833.2 million during the year ended December 31, 2017. Net sales of existingproducts increased primarily as a result of sales of new products and favorable pricing and volume. The favorable impact of foreign currency translation on2017 net sales was $89.7 million, or 3% within Europe. Constant currency net sales increased by approximately $914.8 million, or 31% when compared tothe prior year.50Table of ContentsRest of World SegmentNet sales from Rest of World increased by $448.3 million or 19% during the year ended December 31, 2017 when compared to the prior year. Thisincrease was primarily the result of incremental net sales from the acquisition of Meda totaling approximately $229.2 million. In addition, net sales fromexisting products increased principally as a result of higher volume, particularly from our ARV franchise, and to a lesser extent Australia and the emergingmarkets. Throughout the segment, higher volumes and sales of new products more than offset lower pricing. The favorable impact of foreign currencytranslation was $52.2 million, or 2%. Constant currency net sales increased by approximately $396.1 million, or 17%.Cost of Sales and Gross ProfitCost of sales increased from $6.38 billion for the year ended December 31, 2016 to $7.12 billion for the year ended December 31, 2017. Cost of saleswas primarily impacted by purchase accounting related amortization of acquired intangible assets, acquisition related costs, restructuring, and other specialitems, which are described further in the section titled Use of Non-GAAP Financial Measures. Gross profit for the year ended December 31, 2017 was $4.78billion and gross margins were 40%. For the year ended December 31, 2016, gross profit was $4.70 billion and gross margins were 42%. Gross margins werenegatively impacted in 2017 by incremental amortization expense as a result of the acquisitions of Meda and the Topicals Business by approximately 110basis points, lower gross profit from the sales of existing products in North America, including the EpiPen® Auto-Injector, by approximately 275 basispoints, partially offset by the contributions from the acquired businesses. Adjusted gross margins were approximately 54% for the year ended December 31,2017, compared to approximately 56% for the year ended December 31, 2016. Adjusted gross margins were negatively impacted in the current period as aresult of lower gross profit from the sales of existing products in North America, including the EpiPen® Auto-Injector, by approximately 200 basis points,partially offset by the contributions from the acquired businesses.A reconciliation between cost of sales, as reported under U.S. GAAP, and adjusted cost of sales and adjusted gross margin for the year endedDecember 31, 2017 compared to the year ended December 31, 2016 is as follows: Year Ended December 31,(In millions)2017 2016U.S. GAAP cost of sales$7,124.6 $6,379.9Deduct: Purchase accounting amortization and other related items(1,523.8) (1,389.3)Acquisition related items(2.8) (2.3)Restructuring and related costs(46.0) (31.1)Other special items(63.5) (92.8)Adjusted cost of sales$5,488.5 $4,864.4 Adjusted gross profit (a)$6,419.2 $6,212.5 Adjusted gross margin (a)54% 56%____________(a) Adjusted gross profit is calculated as total revenues less adjusted cost of sales. Adjusted gross margin is calculated as adjusted gross profit dividedby total revenues.Operating ExpensesResearch & Development ExpenseR&D expense for the year ended December 31, 2017 was $783.3 million, compared to $826.8 million for the prior year, a decrease of $43.5 million.The decrease was due to lower spending when compared to the prior year as a result of the Company’s reprioritization of global programs. Partially offsettingthis decrease was the impact from incremental R&D expense related to the acquisitions of Meda and the Topicals Business of approximately $45.4 million inthe current year as well as an increase in restructuring costs included in R&D from $7.7 million in 2016 to $8.4 million in 2017.51Table of ContentsAdditionally, during the year ended December 31, 2017, the Company entered into a joint development and marketing agreement for a respiratoryproduct resulting in approximately $50.0 million in R&D expense. The Company also incurred R&D expense in 2017 of $31.9 million related to thecollaboration agreement with Momenta. In the prior year period, the Company made an upfront payment of $45.0 million and incurred additional R&Dexpense of $29.2 million, both related to the Company’s collaboration agreement with Momenta which was entered into on January 8, 2016.Selling, General & Administrative ExpenseSG&A for the year ended December 31, 2017 was $2.58 billion, compared to $2.50 billion for the prior year, an increase of $77.2 million. Theincrease is due primarily to additional incremental expense related to the acquisitions of Meda and the Topicals Business which increased SG&A byapproximately $213.1 million. Restructuring charges recorded in SG&A were $133.6 million and $113.1 million, respectively, for the years endedDecember 31, 2017 and December 31, 2016. Partially offsetting these increases were acquisition related costs which were $110.8 million lower than the prioryear as well as the year over year benefit of integration activities.Litigation Settlements and Other Contingencies, NetDuring the year ended December 31, 2017, the Company recorded net gains of $13.1 million for litigation settlements and other contingencies, net,compared to a net charge of $672.5 million in the prior year.The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the year ended December 31,2017:(In millions)Loss/(gain)Respiratory delivery platform contingent consideration adjustment$(93.5)Litigation settlements51.1Topicals Business contingent consideration adjustment23.5Jai Pharma Limited contingent consideration adjustment9.8Apicore contingent consideration adjustment(4.0)Total litigation settlements and other contingencies, net$(13.1)The following table includes the losses/(gains) recognized in litigation settlements and other contingencies, net during the year ended December 31,2016:(In millions)Loss/(gain)Medicaid Drug Rebate Program Settlement$465.0Modafinil antitrust litigation settlement165.0Strides Arcolab Limited (“Strides”) Settlement90.0Respiratory delivery platform contingent consideration adjustment(68.5)Jai Pharma Limited contingent consideration adjustment12.6Other litigation settlements8.4Total litigation settlements and other contingencies, net$672.5Interest ExpenseInterest expense for the year ended December 31, 2017 totaled $534.6 million, compared to $454.8 million for the year ended December 31, 2016,an increase of $79.8 million. The increase in 2017 is primarily due to the incremental impact of the issuance of the senior notes in June 2016 and, the Eurosenior notes issued in November 2016 and May 2017. This increase was partially offset by the impact of the repayment of the 1.800% Senior Notes due 2016and the 1.350% Senior Notes due 2016 in June and November of 2016, respectively, as well as the repayment of the Meda Term Loan and the partialrepayment of the Mylan N.V. Term Loan.52Table of ContentsOther (Income) Expense, NetOther (income) expense, net was $0.4 million for the year ended December 31, 2017, compared to net expense of $122.7 million for the prioryear. Other (income) expense, net was comprised of the following for the years ended December 31, 2017 and 2016, respectively: Year Ended December 31,(In millions)2017 2016Losses from equity affiliates, primarily clean energy investments$100.2 $112.8Clean energy investment adjustment, net gain(42.2) —Foreign exchange gains, net(48.1) (0.5)Interest income(6.2) (12.3)Write off of deferred financing fees3.2 34.8Other gains, net(7.3) (12.1)Other (income) expense, net$(0.4) $122.7During 2017, as a result of a decline in current and expected future production levels at certain of the clean energy facilities the Company impairedits investment balance and other assets by approximately $47.0 million and reduced the related long-term obligations for these investments byapproximately $89.0 million resulting in a net gain of $42.0 million which was recognized as a component of the net loss of the equity method investments.In the prior year, other (income) expense, net included a foreign exchange net gain of $0.5 million, which included $128.6 million of losses related to theCompany’s SEK non-designated foreign currency contracts that were entered into to economically hedge the foreign currency exposure associated with theexpected payment of the Swedish krona-denominated cash portion of the purchase price of the offer to the shareholders of Meda to acquire all of theoutstanding shares of Meda. This loss was offset by foreign exchange gains of approximately $30.5 million related to the mark-to-market impact for theNovember 2016 settlement of a portion of outstanding Meda shares and the remaining obligation on non-tendered Meda shares. In addition, the loss wasoffset by foreign exchange gains related to the mark-to-market on Euro denominated notes of approximately $32.0 million and additional net gains as aresult of the Company’s foreign currency exchange risk management program.Income Tax Provision (Benefit)For the year ended December 31, 2017, the Company recognized an income tax provision of $207.0 million, compared to an income tax benefit of$358.3 million for the comparable prior year. On December 22, 2017, the Tax Act was signed into law making significant changes to the Code. Changesinclude, but are not limited to, a U.S. federal corporate income tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017,and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings of non-U.S. corporate subsidiaries of large U.S.shareholders as of December 31, 2017. The Company calculated its best estimate of the impact of the Tax Act in the 2017 income tax provision in accordancewith our understanding of the Tax Act and available guidance and recorded a provisional net tax charge of $128.6 million related to the Tax Act in the yearended December 31, 2017. In addition, the income tax provision for the year ended December 31, 2017 versus the prior year was impacted by the changingmix of income earned in jurisdictions with differing tax rates, statutory releases of certain tax uncertainties, increases in valuation allowances on certaincarryforward tax attributes, the non-recurring nature of tax benefits obtained by the 2016 mergers of certain foreign subsidiaries, and the revaluation ofdeferred tax assets and liabilities in countries that changed their statutory corporate tax rate.Use of Non-GAAP Financial MeasuresWhenever the Company uses non-GAAP financial measures, we provide a reconciliation of the non-GAAP financial measures to their most directlycomparable U.S. GAAP financial measure. Investors and other readers are encouraged to review the related U.S. GAAP financial measures and thereconciliation of non-GAAP measures to their most directly comparable U.S. GAAP measure and should consider non-GAAP measures only as a supplementto, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with U.S. GAAP. Additionally, since these arenot measures determined in accordance with U.S. GAAP, non-GAAP financial measures have no standardized meaning across companies, or as prescribed byU.S. GAAP and, therefore, may not be comparable to the calculation of similar measures or measures with the same title used by other companies.53Table of ContentsManagement uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. Primarilydue to acquisitions and other significant events which may impact comparability of our periodic operating results, we believe that an evaluation of ourongoing operations (and comparisons of our current operations with historical and future operations) would be difficult if the disclosure of our financialresults was limited to financial measures prepared only in accordance with U.S. GAAP. We believe that non-GAAP financial measures are useful supplementalinformation for our investors and when considered together with our U.S. GAAP financial measures and the reconciliation to the most directly comparableU.S. GAAP financial measure, provide a more complete understanding of the factors and trends affecting our operations. The financial performance of theCompany is measured by senior management, in part, using adjusted metrics as described below, along with other performance metrics. Management’s annualincentive compensation is derived, in part, based on the adjusted EPS (as defined below) metric.Adjusted Cost of Sales and Adjusted Gross MarginWe use the non-GAAP financial measure “adjusted cost of sales” and the corresponding non-GAAP financial measure “adjusted gross margin.” Theprincipal items excluded from adjusted cost of sales include restructuring, acquisition related and other special items and purchase accounting amortizationand other related items, which are described in greater detail below.Adjusted Net Earnings and Adjusted EPSAdjusted net earnings is a non-GAAP financial measure and provides an alternative view of performance used by management. Managementbelieves that, primarily due to acquisition activity and other significant events, an evaluation of the Company’s ongoing operations (and comparisons of itscurrent operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures preparedonly in accordance with U.S. GAAP. Management believes that adjusted net earnings and adjusted net earnings per diluted share (“adjusted EPS”) are two ofthe most important internal financial metrics related to the ongoing operating performance of the Company, and are therefore useful to investors and thattheir understanding of our performance is enhanced by these adjusted measures. Actual internal and forecasted operating results and annual budgets used bymanagement include adjusted net earnings and adjusted EPS.The significant items excluded from adjusted cost of sales, adjusted net earnings and adjusted EPS include:Purchase Accounting Amortization and Other Related ItemsThe ongoing impact of certain amounts recorded in connection with acquisitions of both businesses and assets is excluded from adjusted cost ofsales, adjusted net earnings and adjusted EPS. These amounts include the amortization of intangible assets, inventory step-up and intangible assetimpairment charges, including IPR&D. For the acquisition of businesses accounted for under the provisions of the Financial Accounting Standards BoardAccounting Standards Codification (“ASC”) 805, these purchase accounting impacts are excluded regardless of the financing method used for theacquisitions, including the use of cash, long-term debt, the issuance of ordinary shares, contingent consideration or any combination thereof.Upfront and Milestone-Related R&D ExpensesThese expenses and payments are excluded from adjusted net earnings and adjusted EPS because they generally occur at irregular intervals and arenot indicative of the Company’s ongoing operations. Also included in this adjustment are certain expenses related to the Company’s collaborationagreement with Momenta including certain milestone related costs. Such costs include payments related to Mylan’s future decisions, on a product by productbasis, to continue with the development of such product in the collaboration after certain R&D work is performed. Related amounts are excluded fromadjusted net earnings and adjusted EPS as Mylan considers such payments as additional upfront buy-in payments for the products.Accretion of Contingent Consideration Liability and Other Fair Value AdjustmentsThe impact of changes to the fair value of contingent consideration and accretion expense are excluded from adjusted net earnings and adjusted EPSbecause they are not indicative of the Company’s ongoing operations due to the variability of the amounts and the lack of predictability as to the occurrenceand/or timing and management believes their exclusion is helpful to understanding the underlying, ongoing operational performance of the business.54Table of ContentsRestructuring, Acquisition Related and Other Special ItemsCosts related to restructuring, acquisition and integration activities and other actions are excluded from adjusted cost of sales, adjusted net earningsand adjusted EPS, as applicable. These amounts include items such as:•Costs related to formal restructuring programs and actions, including costs associated with facilities to be closed or divested, employeeseparation costs, impairment charges, accelerated depreciation, incremental manufacturing variances, equipment relocation costs and otherrestructuring related costs;•Certain acquisition related remediation and integration and planning costs, as well as other costs associated with acquisitions such as advisoryand legal fees and certain financing related costs, and other business transformation and/or optimization initiatives, which are not part of aformal restructuring program, including employee separation and post-employment costs;•The pre-tax loss of the Company’s clean energy investments, whose activities qualify for income tax credits under the Code; only included inadjusted net earnings and adjusted EPS is the net tax effect of the entity’s activities;•The pre-tax mark-to-market gains and losses of the Company’s investments in marketable equity securities historically accounted for asavailable for sale securities; only included in adjusted net earnings and adjusted EPS are cumulative realized gains and losses;•Certain costs to further develop and optimize our global ERP systems, operations and supply chain; and•Other costs, incurred from time to time, related to certain special events or activities that lead to gains or losses, including, but not limited to,incremental manufacturing variances, asset write-downs, or liability adjustments.The Company has undertaken restructurings and other optimization initiatives of differing types, scope and amount during the covered periods and,therefore, these charges should not be considered non-recurring; however, management excludes these amounts from adjusted net earnings and adjusted EPSbecause it believes it is helpful to understanding the underlying, ongoing operational performance of the business.Litigation Settlements, NetCharges and gains related to legal matters, such as those discussed in the Note 19 Litigation included in Item 8 in this Annual Report on Form 10-Kare generally excluded from adjusted net earnings and adjusted EPS. Normal, ongoing defense costs of the Company made in the normal course of ourbusiness are not excluded.55Table of ContentsReconciliation of Adjusted Net Earnings and Adjusted EPSA reconciliation between net earnings and diluted earnings per share, as reported under U.S. GAAP, and adjusted net earnings and adjusted EPS forthe periods shown follows: Year Ended December 31,(In millions, except per share amounts)2018 2017 2016U.S. GAAP net earnings and U.S. GAAP diluted earnings per share$352.5 $0.68 $696.0 $1.30 $480.0 $0.92Purchase accounting related amortization (primarily included in cost of sales) (a)1,833.9 1,529.7 1,412.3 Litigation settlements and other contingencies, net(49.5) (13.1) 672.5 Interest expense (primarily clean energy investment financing and accretion ofcontingent consideration)39.7 47.3 111.8 Clean energy investments pre-tax loss78.7 47.1 92.3 Acquisition related costs (primarily included in SG&A and cost of sales) (b)21.4 72.8 234.3 Restructuring related costs (c)240.2 188.0 161.6 Other special items included in: Cost of sales (d)225.1 63.5 92.8 Research and development expense (e)118.2 117.7 121.3 Selling, general and administrative expense (f)43.7 11.7 30.4 Other expense, net (g)25.4 13.8 (18.6) Tax effect of the above items and other income tax related items(564.5) (329.7) (843.5) Adjusted net earnings and adjusted EPS$2,364.8 $4.58 $2,444.8 $4.56 $2,547.2 $4.89Weighted average diluted ordinary shares outstanding516.5 536.7 520.5 ____________Significant items for the year ended December 31, 2018 include the following:(a) The increase in purchase accounting related amortization is primarily due to the increase in amortization expense as a result of the full impact ofcertain product rights acquisitions which occurred in 2017, the current year impact of the 2018 product rights acquisitions and impairment chargesof $224.0 million during the year ended December 31, 2018.(b) Acquisition related costs incurred in 2017 and 2018 consist primarily of integration activities.(c) For the year ended December 31, 2018, approximately $118.4 million is included in cost of sales, approximately $17.6 million is included in R&Dand approximately $104.5 million is included in SG&A. Refer to Note 17 Restructuring included in Item 8 in this Annual Report on Form 10-K foradditional information.(d) Increases relate primarily to expenses of $155.8 million for certain incremental manufacturing variances and site remediation activities as a result ofthe activities at the Company’s Morgantown plant and $22.6 million for costs related to the recall of Valsartan products.(e) Adjustment primarily relates to non-refundable payments related to development collaboration agreements.(f) The increase for the year ended December 31, 2018 is primarily related to bad debt expense of approximately $26.5 million primarily related to aspecial business interruption event for one customer.(g) The increase for the year ended December 31, 2018 is primarily related to mark-to-market losses of investments in equity securities historicallyaccounted for as available-for-sale securities and the cumulative realized gains on such investments.Liquidity and Capital ResourcesOur primary source of liquidity is net cash provided by operating activities, which was $2.34 billion for the year ended December 31, 2018. Webelieve that net cash provided by operating activities and available liquidity will continue to allow us to meet our needs for working capital, capitalexpenditures and interest and principal payments on debt obligations. Nevertheless, our ability to satisfy our working capital requirements and debt serviceobligations, or fund planned capital expenditures, will substantially depend upon our future operating performance (which will be affected by prevailingeconomic conditions), and financial, business and other factors, some of which are beyond our control.56Table of ContentsOperating ActivitiesNet cash provided by operating activities increased by $276.9 million to $2.34 billion for the year ended December 31, 2018, as compared to netcash provided by operating activities of $2.06 billion for the year ended December 31, 2017. Net cash provided by operating activities is derived from netearnings adjusted for non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets andliabilities resulting from timing differences between the receipts and payments of cash, including changes in cash primarily reflecting the timing of cashcollections from customers, payments to vendors and employees and tax payments in the ordinary course of business.The net increase in net cash provided by operating activities was principally due to the following:•a net increase in the amount of cash provided by changes in accounts receivable, including estimated sales allowances, of $502.3 million,reflecting the timing of sales, cash collections and customer credits issued related to sales allowances;•a net increase in the amount of cash provided by changes in trade accounts payable of $205.9 million as a result of the timing of cash payments;and•a net decrease in the amount of cash used through changes in other assets and liabilities of $242.4 million, principally due to the timing oflitigation and restructuring payments.These items were partially offset by the following:•a net increase of $418.1 million in the amount of cash used through changes in inventory balances;•an increase in the amount of cash used through changes in income taxes of $39.1 million as a result of the level and timing of estimated taxpayments made during the current period; and•a net decrease in net earnings for the year ended December 31, 2018 of $343.5 million when compared to the prior year period, principally as aresult of a decrease in earnings from operations and a net increase in non-cash expenses of $127.0 million. The increase in non-cash expenseswas primarily due to increased depreciation and amortization of $304.1 million, an increase in loss from equity method investments of $20.7million and decreased litigation settlements and other contingencies, net of $8.5 million partially offset by a net increase in the deferred incometax benefit of $152.9 million and a decrease in share-based compensation expense of $78.0 million.57Table of ContentsInvesting ActivitiesNet cash used in investing activities was $1.21 billion for the year ended December 31, 2018, as compared to net cash used in investing activities of$976.4 million for the year ended December 31, 2017, an increase of $234.0 million.In 2018, significant items in investing activities included the following:•cash paid for acquisitions, net totaling approximately $65.9 million related to the deferred non-contingent purchase price for the acquisition ofApicore;•payments for product rights and other, net totaling approximately $943.5 million, which included payments of approximately $839 millionrelated to commercialized product rights, primarily related to the worldwide rights to the TOBI Podhaler® and TOBI® solution, Betadine incertain European markets and other products in certain rest of world markets;•proceeds from the sale of certain assets during the year totaling approximately $29.3 million; and•capital expenditures, primarily for equipment and facilities, totaling approximately $252.1 million. While there can be no assurance that currentexpectations will be realized, capital expenditures for the 2019 calendar year are expected to be approximately $250 million to $400 million.In 2017, significant items in investing activities included the following:•cash paid for acquisitions, net totaling approximately $167.0 million related to the acquisition of Apicore and the acquisition of the remainingnon-tendered shares of Meda in the compulsory acquisition proceeding;•payments for product rights and other, net totaling approximately $620.3 million, which included a payment of $50.0 million related to theacquisition of intellectual property rights for the Cold-EEZE® brand cold remedy line, payments of $291.8 million related to acquisitions ofadditional intellectual property rights and marketing authorizations and a payment of $256.7 million related to the acquisition of a portfolio ofgeneric product rights in the U.S.;•proceeds from the sale of certain assets and subsidiaries and assets during the year totaling approximately $86.7 million; and•capital expenditures, primarily for equipment and facilities, totaling approximately $275.9 million.Financing ActivitiesNet cash used in financing activities was $1.09 billion for the year ended December 31, 2018, as compared to net cash used in financing activities of$1.89 billion for the year ended December 31, 2017, a decrease of $802.2 million.58Table of ContentsIn 2018, significant items in financing activities included the following:•long-term debt proceeds of approximately $2.58 billion primarily related to borrowings of approximately $496.5 million under the 2016Revolving Facility, proceeds from the April 2018 Senior Notes offering of approximately $1.50 billion and proceeds from the May 2018 EuroSenior Notes offering of approximately €500 million (each as defined in Note 9 Debt included in Item 8 in this Annual Report on Form 10-K);•long-term debt payments of approximately $3.17 billion consisting primarily of repayments of borrowings of approximately $496.5 millionunder the 2016 Revolving Facility, redemptions of $1.50 billion principal amount of senior notes in connection with the April 2018 SeniorNotes offering, redemptions of $600.0 million principal amount of senior notes in connection with the May 2018 Euro Senior Notes offeringand repayment at maturity of €500.0 million principal amount of the Floating Rate Euro Notes due 2018;•net repayments of short-term borrowings of approximately $44.4 million; and•the Company repurchased 9.8 million ordinary shares at a cost of approximately $432.0 million and completed the $1 billion share repurchaseprogram that was previously approved by the Company’s Board of Directors and announced on November 16, 2015 (“Share RepurchaseProgram”).In 2017, significant items in financing activities included the following:•long-term debt proceeds of approximately $554.5 million related to the issuance of the €500 million May 2017 Floating Rate Euro SeniorNotes (as defined below), $320.0 million related to borrowings under the 2016 Revolving Facility and $45.0 million borrowed under theReceivables Facility (as defined below);•long-term debt repayments consisting of a voluntarily prepayment of $1.50 billion of the 2016 Term Facility (as defined in Note 9 Debt in Item8 in this Annual Report on Form 10-K), the repayment of the Meda related debt during the year totaling approximately $408.0 million andrepayments of $320.0 million of the borrowings under the 2016 Revolving Facility; and•the Company repurchased 12.4 million ordinary shares at a cost of approximately $500.2 million as part of the Share Repurchase Program.Capital ResourcesOur cash and cash equivalents totaled $388.1 million at December 31, 2018, and the majority of these funds are held by our non-U.S. subsidiaries.The Company anticipates having sufficient liquidity, including existing borrowing capacity under the 2018 Revolving Facility (as defined below),including the commercial paper program combined with cash to be generated from operations to fund foreseeable cash needs.On December 22, 2017, the U.S. government enacted the Tax Act which makes broad and complex changes to the Code including, but not limitedto, reducing the U.S. federal corporate income tax rate and requiring a one-time transition tax on certain unrepatriated earnings of non-U.S. corporatesubsidiaries of large U.S. shareholders that may electively be paid over eight years. Our estimate of the transition tax obligation is $99.1 million, which theCompany has begun to pay, net of certain tax attributes and credit carryforwards, over eight years beginning in 2018.As of December 31, 2018, our practice and intention was to reinvest the earnings in our non-U.S. subsidiaries outside of the U.S., and no U.S.deferred income taxes or foreign withholding taxes were recorded. The transition tax noted above resulted in the previously untaxed foreign earnings of U.S.subsidiaries being included in the federal and state taxable income.59Table of ContentsWe analyze on an ongoing basis our global working capital requirements and the potential tax liabilities that would be incurred if the non-U.S. subsidiariesrepatriate cash, which include potential local country withholding taxes and U.S. state taxation.The Company has access to $2.00 billion under the 2018 Revolving Facility. As of December 31, 2018, the Company had no amounts outstandingunder the 2018 Revolving Facility (as defined below). Up to $1.65 billion of the 2018 Revolving Facility may be used to support future borrowings underour commercial paper program.In addition to the 2018 Revolving Facility, Mylan Pharmaceuticals Inc. (“MPI”), a wholly owned subsidiary of the Company, has a $400 millionreceivables facility (the “Receivables Facility”), which expires on March 25, 2019. From time-to-time, the available amount of the Receivables Facility maybe less than $400 million based on accounts receivable concentration limits and other eligibility requirements. Under the terms of the Receivables Facility,MPI sells certain accounts receivable to Mylan Securitization LLC, a wholly owned special purpose entity which in turn sells a percentage of ownershipinterest in the receivables to financial institutions and commercial paper conduits sponsored by financial institutions. As of December 31, 2018, theCompany had no short-term borrowings under the Receivables Facility.At December 31, 2018, our long-term debt, including the current portion, totaled $13.82 billion, as compared to $14.61 billion at December 31,2017. The decrease in long-term debt was due to redemptions of senior notes partially offset by issuances of senior notes in connection with the April 2018Senior Notes offering and the May 2018 Euro Senior Notes offering and repayment at maturity of the Floating Rate Euro Notes due 2018 during the yearended December 31, 2018. The total long-term debt balance at December 31, 2018 was comprised primarily of $12.66 billion of fixed rate senior notes and$573.3 million of floating rate senior notes. In addition, at December 31, 2018, we had $655.2 million of long-term debt classified as current and payablewithin the next twelve months, as compared to $1.75 billion at December 31, 2017. The decrease to the current portion of long-term debt is due to theredemptions of the 2.600% Senior Notes due 2018, the 3.000% Senior Notes due 2018 and the repayment of the Floating Rate Euro Notes due 2018 partiallyoffset by reclassification of the 2016 Term Facility which matures in November 2019 and the 2.500% Senior Notes due 2019 which mature in June 2019. TheCompany intends to utilize available liquidity to fund these repayments.For additional information regarding our debt agreements, refer to Note 9 Debt included in Item 8 in this Annual Report on Form 10-K.Long-term Debt MaturityMandatory minimum repayments remaining on the outstanding long-term debt at December 31, 2018, excluding the discounts and premiums, are asfollows for each of the periods ending December 31:The Company’s term credit facility dated as of November 22, 2016 (as amended, supplemented or otherwise modified from time to time, the “2016Term Facility”), among the Company, certain affiliates and subsidiaries of the Company from time to time party thereto as guarantors, each lender from timeto time party thereto and Goldman Sachs Bank USA, as administrative agent and the Company’s revolving credit facility dated as of July 27, 2018 (asamended, supplemented or otherwise modified from time to time, the “2018 Revolving Facility”), among Mylan Inc., as borrower, the Company, as aguarantor, certain lenders and issuing banks and Bank of America, N.A., as the administrative agent, contain customary affirmative covenants for facilities ofthis type, including among others, covenants pertaining to the delivery of financial statements, notices of default and certain material events, maintenance ofcorporate existence and rights, property, and insurance and compliance with laws, as well as customary negative covenants for facilities of this type,including limitations on the incurrence of subsidiary indebtedness, liens, mergers and certain other fundamental changes, investments and loans,acquisitions, transactions with affiliates, payments of dividends and other restricted payments and changes in our lines of business.60Table of ContentsThe 2016 Term Facility and 2018 Revolving Facility contain a maximum consolidated leverage ratio financial covenant requiring maintenance of amaximum ratio of 3.75 to 1.00 for consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters asdefined in the related credit agreements (“leverage ratio”).The 2016 Term Facility was amended in November 2017 to allow a leverage ratio of 4.25 to 1.00 through the December 31, 2018 reporting periodand a leverage ratio of 3.75 to 1.00 thereafter. The 2018 Revolving Facility similarly provides for a leverage ratio of 4.25 to 1.00 through the December 31,2018 reporting period and a leverage ratio of 3.75 to 1.00 thereafter. On February 22, 2019, the Company, as a guarantor, and Mylan Inc., as borrower, enteredinto an amendment (the "Revolving Loan Amendment") to the 2018 Revolving Facility. In addition, on February 22, 2019, the Company entered into anamendment (the "Term Loan Amendment") to the 2016 Term Facility. The Revolving Loan Amendment and the Term Loan Amendment extended theleverage ratio covenant of 4.25 to 1.00 through the December 31, 2019 reporting period, with a leverage ratio of 3.75 to 1.00 thereafter. The Company is incompliance at December 31, 2018 and expects to remain in compliance for the next twelve months.Other CommitmentsThe Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings andlitigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civilpenalties, and/or criminal charges against the Company. These matters are often complex and have outcomes that are difficult to predict. The Company isalso party to certain proceedings and litigation matters for which it may be entitled to indemnification under the respective sale and purchase agreementsrelating to the acquisitions of the former Merck Generics business, Agila Specialties Private Limited, the EPD Business, and certain other acquisitions. Wehave approximately $54 million accrued for legal contingencies at December 31, 2018.While the Company believes that it has meritorious defenses with respect to the claims asserted against it and intends to vigorously defend itsposition, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict theultimate resolution of any such matter. It is possible that an unfavorable resolution of any of the ongoing matters or the inability or denial of Merck KGaA,Strides, Abbott Laboratories, or another indemnitor or insurer to pay an indemnified claim, could have a material adverse effect on the Company’s business,financial condition, results of operations, cash flows and/or ordinary share price.We are continuously evaluating the potential acquisition of products, as well as companies, as a strategic part of our future growth. Consequently,we may utilize current cash reserves or incur additional indebtedness to finance any such acquisitions, which could impact future liquidity. In addition, on anongoing basis, we review our operations including the evaluation of potential divestitures of products and businesses as part of our future strategy. Anydivestitures could impact future liquidity.Contractual ObligationsThe following table summarizes our contractual obligations at December 31, 2018 and the effect that such obligations are expected to have on ourliquidity and cash flows in future periods:(In millions)Total Less thanOne Year One- ThreeYears Three- FiveYears ThereafterLong-term debt$13,913.0 $650.0 $4,183.0 $1,250.0 $7,830.0Scheduled interest payments (1)5,237.5 466.0 844.6 689.9 3,237.0Operating leases (2)269.6 73.7 94.9 46.8 54.2Other Commitments (3)1,565.0 797.5 434.6 115.4 217.5 $20,985.1 $1,987.2 $5,557.1 $2,102.1 $11,338.7____________(1) Scheduled interest payments represent the estimated interest payments related to our outstanding borrowings under term loans, senior notes andother long-term debt. Variable debt interest payments are estimated using current interest rates.(2) We lease certain properties under various operating lease arrangements that generally expire over the next five to seven years. These leases generallyprovide us with the option to renew the lease at the end of the lease term.61Table of Contents(3) Other commitments include funding commitments related to the Company’s clean energy investments, agreements to purchase third-partymanufactured products, open purchase orders, transition tax, estimated post-employment payments and capital leases at December 31, 2018.Due to the uncertainty with respect to the timing of future payments, if any, the following contingent payments have not been included in the tableabove.We are contractually obligated to make potential future development, regulatory and commercial milestone, royalty and/or profit sharing paymentsin conjunction with acquisitions we have entered into with third parties. The most significant of these relates to the potential future consideration related tothe acquisition of the exclusive worldwide rights to develop, manufacture and commercialize a generic equivalent to GlaxoSmithKline’s Advair® Diskus andSeretide® incorporating Pfizer’s proprietary dry powder inhaler delivery platform (the “respiratory delivery platform”). These payments are contingent uponthe occurrence of certain future events and, given the nature of these events, it is unclear when we may be required to pay such amounts. The amount of thecontingent consideration liabilities was $355.3 million at December 31, 2018. In addition, the Company expects to incur approximately $15 million to $20million of non-cash accretion expense related to the increase in the net present value of the contingent consideration liabilities in 2019.With respect to the timing of future cash flows associated with our unrecognized tax benefits at December 31, 2018, we are unable to makereasonably reliable estimates of the period of cash settlement with the respective taxing authority. As such, $96.3 million of unrecognized tax benefits havebeen excluded from the contractual obligations table above.We have entered into employment and other agreements with certain executives and other employees that provide for compensation and certainother benefits. These agreements provide for severance payments under certain circumstances. Certain commercial agreements require us to provideperformance bonds and/or indemnification; while it is difficult to forecast the amount of payments, if any, to be made over the next few years, we do notbelieve the amount would be material to our results of operations, cash flows or financial condition.Collaboration and Licensing AgreementsWe periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture,marketing and/or sale of pharmaceutical products. Our significant collaboration agreements are primarily focused on the development, manufacturing, supplyand commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other complexproducts. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of ourlicensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction orachievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone paymentobligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities inthe Consolidated Balance Sheets, except for milestone and royalty obligations reflected as acquisition related contingent consideration. Refer to Note 8Financial Instruments and Risk Management included in Item 8 in this Annual Report on Form 10-K for further discussion of contingent consideration. Ourpotential maximum development milestones not accrued for at December 31, 2018 totaled approximately $425 million. We estimate that the amounts thatmay be paid in the next twelve months to be approximately $35 million. These agreements may also include potential sales-based milestones and call for usto pay a percentage of amounts earned from the sale of the product as a royalty or a profit share. The amounts disclosed do not include sales-based milestonesor royalty obligations on future sales of product as the timing and amount of future sales levels and costs to produce products subject to these obligations isnot reasonably estimable. These sales-based milestones or royalty obligations may be significant depending upon the level of commercial sales for eachproduct.The Company’s significant collaboration and licensing agreements include agreements with Pfizer, Momenta, Theravance Biopharma, and Biocon.Refer to Note 18 Collaboration and Licensing Agreements included in Item 8 in this Annual Report on Form 10-K for additional information related to ourcollaborations.Impact of Currency Fluctuations and InflationBecause our results are reported in U.S. Dollars, changes in the rate of exchange between the U.S. Dollar and the local currencies in the markets inwhich we operate, mainly the Euro, Swedish Krona, Indian Rupee, Japanese Yen, Australian Dollar, Canadian Dollar, Pound Sterling and Brazilian Real affectour results as previously noted. We do not believe that inflation has had a material impact on our revenues or operations in any of the past three years.62Table of ContentsApplication of Critical Accounting PoliciesOur significant accounting policies are described in Note 2 Summary of Significant Accounting Policies included in Item 8 in this Annual Report onForm 10-K and are in accordance with U.S. GAAP.Included within these policies are certain policies which contain critical accounting estimates and, therefore, have been deemed to be “criticalaccounting policies.” Critical accounting estimates are those which require management to make assumptions about matters that were uncertain at the timethe estimate was made and for which the use of different estimates, which reasonably could have been used, or changes in the accounting estimates that arereasonably likely to occur from period to period could have a material impact on our financial condition or results of operations. We have identified thefollowing to be our critical accounting policies: the determination of net revenue provisions, acquisitions, intangible assets, goodwill and contingentconsideration, income taxes and the impact of existing legal matters.Revenue RecognitionOn January 1, 2018, the Company adopted ASC Topic 606 Revenue from Contracts with Customers (“ASC 606”) using the modified retrospectivemethod applied to those contracts which were not completed as of the date of adoption. Results for reporting periods beginning on January 1, 2018 arepresented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with ASC Topic 605 RevenueRecognition (“ASC 605”). Under ASC 605, the Company recognized net sales when title and risk of loss passed to its customers and when provisions forestimates, as described below, were reasonably determinable.Under ASC 606, the Company recognizes net revenue for product sales when control of the promised goods or services is transferred to ourcustomers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Revenues are recorded net ofprovisions for variable consideration, including discounts, rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotionalprograms and other sales allowances. Accruals for these provisions are presented in the consolidated financial statements as reductions in determining netsales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). The following briefly describes thenature of our provisions for variable consideration and how such provisions are estimated:•Chargebacks: the Company has agreements with certain indirect customers, such as independent pharmacies, retail pharmacy chains, managed careorganizations, hospitals, nursing homes, governmental agencies and pharmacy benefit managers, which establish contract prices for certain products.The indirect customers then independently select a wholesaler from which to purchase the products at these contracted prices. Alternatively, certainwholesalers may enter into agreements with indirect customers that establish contract pricing for certain products, which the wholesalers provide.Under either arrangement, Mylan will provide credit to the wholesaler for any difference between the contracted price with the indirect party and thewholesaler’s invoice price. Such credits are called chargebacks. The provision for chargebacks is based on expected sell-through levels by ourwholesaler customers to indirect customers, as well as estimated wholesaler inventory levels. We continually monitor our provision for chargebacksand evaluate our reserve and estimates as additional information becomes available. A change of 5% would have an effect on our reserve balance ofapproximately $23.9 million.•Rebates, promotional programs and other sales allowances: this category includes rebate and other programs to assist in product sales. Theseprograms generally provide that the customer receives credit directly related to the amount of purchases or credits upon the attainment of pre-established volumes. Also included in this category are prompt pay discounts, administrative fees and price adjustments to reflect decreases in theselling prices of products. A change of 5% would have an effect on our reserve balance of approximately $60.1 million.•Returns: consistent with industry practice, Mylan maintains a return policy that allows customers to return a product, which varies country bycountry in accordance with local practices, generally within a specified period prior (six months) and subsequent (twelve months) to the expirationdate. The Company’s estimate of the provision for returns is generally based upon historical experience with actual returns. A change of 5% wouldhave an effect on our reserve balance of approximately $22.0 million.•Governmental rebate programs: government reimbursement programs include Medicare, Medicaid, and State Pharmacy Assistance Programsestablished according to statute, regulations and policy. Manufacturers of pharmaceutical products that are covered by the Medicaid program arerequired to pay rebates to each state based on a statutory formula set forth in the Social Security Act. Medicare beneficiaries are eligible to obtaindiscounted prescription drug coverage from private sector providers. In addition, certain states have also implemented supplemental rebate programsthat obligate manufacturers to pay rebates in excess of those required under federal law. Our estimate of these rebates is based on the historical trendsof rebates paid as well as on changes in wholesaler63Table of Contentsinventory levels and increases or decreases in the level of sales. Also, this provision includes price reductions that are mandated by law outside ofthe U.S. A change of 5% would have an effect on our reserve balance of approximately $11.1 million.The following is a rollforward of the categories of variable consideration during 2018:(In millions)Balance atDecember 31,2017 Current ProvisionRelated to SalesMade in theCurrent Period Checks/ CreditsIssued to ThirdParties Effects of ForeignExchange Balance atDecember 31,2018Chargebacks$574.3 $3,352.2 $(3,447.1) $(1.2) $478.2Rebates, promotional programs and other sales allowances1,508.1 4,235.6 (4,526.0) (15.3) 1,202.4Returns472.5 261.6 (292.1) (2.5) 439.5Governmental rebate programs240.3 470.0 (486.6) (1.5) 222.2Total$2,795.2 $8,319.4 $(8,751.8) $(20.5) $2,342.3Accruals for these provisions are presented in the Consolidated Financial Statements as reductions in determining net revenues and in accountsreceivable and other current liabilities. Accounts receivable are presented net of allowances relating to these provisions, which were comprised of thefollowing at December 31, 2018 and 2017, respectively:(In millions)December 31, 2018 December 31, 2017Accounts receivable$1,715.6 $1,977.2Other current liabilities626.7 818.0Total$2,342.3 $2,795.2We have not made and do not anticipate making any significant changes to the methodologies that we use to measure provisions for variableconsideration; however, the balances within these reserves can fluctuate significantly through the consistent application of our methodologies. Historically,we have not recorded in any current period any material amounts related to adjustments made to prior period reserves.Acquisitions, Intangible Assets, Goodwill and Contingent ConsiderationWe account for acquired businesses using the acquisition method of accounting in accordance with the provisions of ASC 805, which requires thatthe assets acquired and liabilities assumed be recorded at the date of acquisition at their respective estimated fair values. The cost to acquire businesses hasbeen allocated to the underlying net assets of the acquired businesses based on estimates of their respective fair values. Amounts allocated to acquiredIPR&D are capitalized at the date of an acquisition and, at that time, such IPR&D assets have indefinite lives. As products in development are approved forsale, amounts will generally be allocated to product rights and licenses and will be amortized over their estimated useful lives. Finite-lived intangible assetsare amortized over the expected life of the asset. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded asgoodwill.Purchases of developed products and licenses that are accounted for as an asset acquisition are capitalized as intangible assets and amortized over anestimated useful life. IPR&D assets acquired as part of an asset acquisition are expensed immediately if they have no alternative future uses.The judgments made in determining the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives,can materially impact our results of operations. Fair values and useful lives are determined based on, among other factors, the expected future period ofbenefit of the asset, the various characteristics of the asset and projected cash flows. Because this process involves management making estimates with respectto future sales volumes, pricing, new product launches, government reform actions, anticipated cost environment and overall market conditions, and becausethese estimates form the basis for the determination of whether or not an impairment charge should be recorded, these estimates are considered to be criticalaccounting estimates.64Table of ContentsWe record contingent consideration resulting from a business acquisition at its estimated fair value on the acquisition date. Each reporting periodthereafter, we revalue these obligations and record increases or decreases in their fair value as an adjustment to litigation settlements and other contingencies,net within the Consolidated Statements of Operations. Changes in the fair value of the contingent consideration obligations can result from adjustments tothe discount rates, payment periods and adjustments in the probability of achieving future development steps, regulatory approvals, market launches, salestargets and profitability. These fair value measurements represent Level 3 measurements as they are based on significant inputs not observable in the market.Significant judgment is employed in determining the assumptions utilized as of the acquisition date and for each subsequent measurement period.Accordingly, changes in assumptions described above, could have a material impact on our consolidated results of operations.Goodwill and intangible assets, including IPR&D, are reviewed for impairment annually and/or when events or other changes in circumstancesindicate that the carrying amount of the assets may not be recoverable. Impairment of goodwill and indefinite-lived intangibles, including IPR&D, isdetermined to exist when the fair value is less than the carrying value of the net assets being tested, with any impairment charge being equal to the difference.Impairment of finite-lived intangibles is determined to exist when undiscounted cash flows related to the assets are less than the carrying value of the assetsbeing tested. Future events and decisions may lead to asset impairment and/or related costs.Goodwill is allocated and evaluated for impairment at the reporting unit level, which is defined as an operating segment or one level below anoperating segment. The Company has four reporting units, North America Generics, North America Brands, Europe and Rest of World and completes itsannual goodwill impairment test as of April 1st. As of April 1, 2018, the date of our most recent annual impairment test, the allocation of the Company’s totalgoodwill was as follows: North America Generics $2.89 billion, North America Brands $660.0 million, Europe $4.97 billion and Rest of World $1.80 billion.The Company performed a quantitative impairment analysis for all of its reporting units as of April 1, 2018. The impairment analysis consists of acomparison of the estimated fair value of the individual reporting units with their carrying amount, including goodwill. In estimating each reporting unit’sfair value, we performed extensive valuation analysis utilizing both income and market-based approaches, in our goodwill assessment process. We utilized anaverage of the two methods in estimating the fair value of the individual reporting units, except for the North America Brands reporting unit where the fairvalue was estimated utilizing the income approach. The following describes the valuation methodologies used to derive the estimated fair value of thereporting units.Income Approach: Under this approach, to determine fair value, we discounted the expected future cash flows of each reporting unit. We used adiscount rate, which reflected the overall level of inherent risk and the rate of return an outside investor would have expected to earn. To estimate cash flowsbeyond the final year of our model, we used a terminal value approach. Under this approach, we used EBITDA in the final year of our model, adjusted toestimate a normalized cash flow, applied a perpetuity growth assumption, and discounted by a perpetuity discount factor to determine the terminal value. Weincorporated the present value of the resulting terminal value into our estimate of fair value.Market-Based Approach: The Company also utilizes a market-based approach to estimate fair value, principally utilizing the guideline companymethod which focuses on comparing our risk profile and growth prospects to a select group of publicly traded companies with reasonably similar guidelines.As of April 1, 2018, the Company determined that the fair value of the North America Generics, North America Brands and Rest of World reportingunits was substantially in excess of the respective unit’s carrying value. For the Europe reporting unit, the estimated fair value exceeded its carrying value byapproximately $800.0 million or 6%. The excess fair value for the Europe reporting unit is consistent with the result of the Company’s 2017 annualimpairment test. As it relates to the income approach for the Europe reporting unit at April 1, 2018, the Company forecasted cash flows for the next 5 years.During the forecast period, the revenue compound annual growth rate was approximately 3.5%. A terminal value year was calculated with a 2.0% revenuegrowth rate applied. The discount rate utilized was 9.0% and the estimated tax rate was 24.0%. Under the market-based approach, we utilized an estimatedrange of market multiples of 9.0 to 10.5 times EBITDA plus a control premium of 15.0%. If all other assumptions are held constant, a reduction in theterminal value growth rate by 2.0% or an increase in discount rate by 1.5% would result in an impairment charge for the Europe reporting unit.The determination of the fair value of the reporting units requires us to make significant estimates and assumptions that affect the reporting unit’sexpected future cash flows. These estimates and assumptions primarily include, but are not limited to, market multiples, control premiums, the discount rate,terminal growth rates, operating income before depreciation and amortization, and capital expenditures forecasts. Due to the inherent uncertainty involved inmaking these estimates, actual65Table of Contentsresults could differ from those estimates. In addition, changes in underlying assumptions, especially as it relates to the key assumptions detailed, could have asignificant impact on the fair value of the reporting units.We have also assessed the recoverability of certain long-lived assets, principally finite-lived intangible assets, contained within the reporting unitswhenever certain impairment indicators are present. Any impairment of these assets must be considered prior to our impairment review of goodwill. Theassessment for impairment is based on our ability to recover the carrying value of the long-lived assets or asset grouping by analyzing the expected futureundiscounted pre-tax cash flows specific to the asset or asset grouping. If the carrying amount is greater than the undiscounted cash flows, the Companyrecognizes an impairment loss for the carrying amount over the estimated fair value based on the discounted cash flows.Significant management judgment is involved in estimating the recoverability of these assets and is dependent upon the accuracy of theassumptions used in making these estimates, as well as how the estimates compare to the eventual future operating performance of the specific asset or assetgrouping. For the years ended December 31, 2018, 2017 and 2016, the Company recorded $106.3 million, $6.2 million, and $18.4 million, respectively, ofimpairment charges for finite-lived intangible assets, which were recorded as a component of amortization expense. At December 31, 2018 and 2017, theCompany’s finite-lived intangible assets totaled $13.04 billion and $14.43 billion, respectively. Changes to any of the Company’s assumptions related to theestimated fair value based on the discounted cash flows, including discount rates or the competitive environment related to the assets, could lead to futurematerial impairment charges. Any future long-lived assets impairment charges could have a material impact the on Company’s consolidated financialcondition and results of operations.The Company’s IPR&D assets are tested at least annually for impairment, but they may be tested whenever certain impairment indicators are present.Impairment is determined to exist when the fair value of IPR&D assets, which was based upon updated forecasts and commercial development plans, is lessthan the carrying value of the assets being tested. For the years ended December 31, 2018, 2017 and 2016, the Company recorded $117.7 million, $74.6million, and $49.9 million, respectively, of impairment charges, which were recorded as a component of amortization expense. At December 31, 2018 and2017, the Company’s IPR&D assets totaled $625.6 million and $813.2 million, respectively.The fair value of both IPR&D and finite-lived intangible assets was determined based upon detailed valuations employing the income approachwhich utilized Level 3 inputs, as defined in Note 8 Financial Instruments and Risk Management included in Item 8 in this Annual Report on Form 10-K.Changes to any of the Company’s assumptions including changes to or abandonment of development programs, regulatory timelines, discount rates or thecompetitive environment related to the assets could lead to future material impairment charges.Income TaxesWe compute our income taxes based on the statutory tax rates and tax reliefs available to Mylan in the various jurisdictions in which we generateincome. Significant judgment is required in determining our income taxes and in evaluating our tax positions. We establish reserves in accordance withMylan’s policy regarding accounting for uncertainty in income taxes. Our policy provides that the tax effects from an uncertain tax position be recognized inMylan’s financial statements, only if the position is more likely than not of being sustained upon audit, based on the technical merits of the position. Weadjust these reserves in light of changing facts and circumstances, such as the settlement of a tax audit. Our provision for income taxes includes the impact ofreserve provisions and changes to reserves. Favorable resolution would be recognized as a reduction to our provision for income taxes in the period ofresolution or expiration of the underlying statutes of limitation. Based on this evaluation, as of December 31, 2018, our reserve for unrecognized tax benefitstotaled $96.3 million.Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize theexisting deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred in certain taxing jurisdictions overthe three-year period ended December 31, 2018. Such objective evidence limits the ability to consider other subjective evidence such as our projections forfuture growth.Based on this evaluation and other factors, as of December 31, 2018, a valuation allowance of $806.0 million has been recorded in order to measureonly the portion of the deferred tax asset that more likely than not will be realized. The amount of the deferred tax asset considered realizable, however, couldbe adjusted if estimates of future taxable income during the carryforward period are reduced or if objective negative evidence in the form of cumulative lossesis no longer present and additional weight may be given to subjective evidence such as projections for growth. When assessing the realizability of deferredtax assets, management considers all available evidence, including historical information, long-term forecasts of future taxable income and possible taxplanning strategies. Amounts recorded for valuation allowances can result from a complex series of estimates, assumptions and judgments about futureevents. Due to the inherent uncertainty involved in making these estimates, assumptions and judgments, actual results could differ materially. Any futureincreases to the Company’s valuation66Table of Contentsallowances could materially impact the Company’s consolidated financial condition and results of operations. At December 31, 2018 and 2017, theCompany’s net deferred tax assets totaled $572.2 million and $496.8 million, respectively.On December 22, 2017, the Tax Act was signed into law making significant changes to the Code. Changes include, but are not limited to, a U.S.federal corporate income tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017, the partial transition of U.S.international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulativeforeign earnings of non-U.S. corporate subsidiaries of large U.S. shareholders as of December 31, 2017. A variance of 5% between estimated reserves andvaluation allowances and actual resolution and realization of these tax items would have an effect on our reserve balance and valuation allowance ofapproximately $45.3 million.Legal MattersMylan is involved in various legal proceedings, some of which involve claims for substantial amounts. An estimate is made to accrue for a losscontingency relating to any of these legal proceedings if it is probable that a liability was incurred as of the date of the financial statements and the amount ofloss can be reasonably estimated. Because of the subjective nature inherent in assessing the outcome of litigation and because of the potential that an adverseoutcome in a legal proceeding could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or ordinaryshare price, such estimates are considered to be critical accounting estimates.A variance of 5% between estimated and recorded litigation reserves and actual resolution of certain legal matters would have an effect on ourlitigation reserve balance of approximately $2.7 million. Refer to Note 19 Litigation included in Item 8 in this Annual Report on Form 10-K for furtherdiscussion of litigation matters.Recent Accounting PronouncementsRefer to Note 2 Summary of Significant Accounting Policies in Item 8 in this Annual Report on Form 10-K for recently adopted accountingpronouncements and recently issued accounting pronouncements not yet adopted.ITEM 7A.Quantitative and Qualitative Disclosures About Market RiskForeign Currency Exchange RiskA significant portion of our revenues and earnings are exposed to changes in foreign currency exchange rates. We seek to manage this foreignexchange risk in part through operational means, including managing same currency revenues in relation to same currency costs and same currency assets inrelation to same currency liabilities.From time to time, foreign exchange risk is managed through the use of foreign currency forward-exchange contracts. These contracts are used tooffset the potential earnings effects from mostly intercompany foreign currency assets and liabilities that arise from operations and from intercompany loans.Mylan’s primary areas of foreign exchange risk relative to the U.S. Dollar are the Euro, Swedish Krona, Indian Rupee, Japanese Yen, Australian Dollar,Canadian Dollar, Pound Sterling and Brazilian Real. Any unhedged foreign exchange exposures continue to be subject to market fluctuations.Our financial instrument holdings at year end were analyzed to determine their sensitivity to foreign exchange rate changes. The fair values of theseinstruments were determined as follows:•foreign currency forward-exchange contracts — net present values•foreign currency denominated receivables, payables, debt and loans — changes in exchange ratesIn this sensitivity analysis, we assumed that the change in one currency’s rate relative to the U.S. Dollar would not have an effect on other currencies’rates relative to the U.S. Dollar. All other factors were held constant.If there were an adverse change in foreign currency exchange rates of 10%, the expected net effect on net income related to Mylan’s foreign currencydenominated financial instruments would not be material.The Company is also exposed to translation risk on non-U.S. dollar-denominated net assets. Non-U.S. dollar borrowings, principally our Eurodenominated long-term debt, are used to hedge the foreign currency exposures of our net investment in certain foreign affiliates and are designated as hedgesof net investments. The foreign exchange gains or losses on these hedges is included in the foreign currency translation component of accumulated othercomprehensive income/(loss). If67Table of Contentsour net investment decreases below the equivalent value of the non-U.S. debt borrowings, the change in the remeasurement basis of the debt would be subjectto recognition in net income as changes occur.Interest Rate and Long-Term Debt RiskMylan’s exposure to interest rate risk arises primarily from our U.S. Dollar and Euro borrowings and U.S. Dollar investments. We invest primarily ona variable-rate basis and we borrow on both a fixed and variable basis. In order to maintain a certain ratio of fixed to variable rate debt, from time to time,depending on market conditions, Mylan will use derivative financial instruments such as interest rate swaps to fix interest rates on variable-rate borrowings orto convert fixed-rate borrowings to variable interest rates.As of December 31, 2018, Mylan’s long-term fixed rate borrowings consist principally of $12.5 billion notional amount of senior notes and Euronotes. Generally, the fair value of fixed interest rate debt will decrease as interest rates rise and increase as interest rates fall. As of December 31, 2018, the fairvalue of our outstanding fixed rate senior notes and Euro notes was approximately $13.1 billion. A 100 basis point change in interest rates on Mylan’svariable rate debt, net of interest rate swaps, would result in a change in interest expense of approximately $14.3 million per year.68Table of ContentsITEM 8.Financial Statements And Supplementary DataIndex to Consolidated Financial Statements andSupplementary Financial Information Page Management’s Report on Internal Control over Financial Reporting70 Reports of Independent Registered Public Accounting Firm71 Consolidated Balance Sheets as of December 31, 2018 and 201773 Consolidated Statements of Operations for the Years Ended December 31, 2018, 2017 and 201674 Consolidated Statements of Comprehensive Earnings for the Years Ended December 31, 2018, 2017 and 201675 Consolidated Statements of Equity for the Years Ended December 31, 2018, 2017 and 201676 Consolidated Statements of Cash Flows for the Years Ended December 31, 2018, 2017 and 201677 Notes to Consolidated Financial Statements78 Supplementary Financial Information15769Table of ContentsManagement’s Report on Internal Control over Financial ReportingManagement of Mylan N.V. (the “Company”) is responsible for establishing and maintaining adequate internal control over financial reporting.Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and thepreparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America. Inorder to evaluate the effectiveness of internal control over financial reporting, management has conducted an assessment, including testing, using the criteriain Internal Control - Integrated Framework (2013), issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Becauseof its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliancewith the policies or procedures may deteriorate.As a result of this assessment, management has concluded that the Company maintained effective internal control over financial reporting as ofDecember 31, 2018 based on the criteria in Internal Control - Integrated Framework (2013) issued by COSO.Our independent registered public accounting firm, Deloitte & Touche LLP, has audited the effectiveness of the Company’s internal control overfinancial reporting. Deloitte & Touche LLP’s opinion on the Company’s internal control over financial reporting appears on page 73 of this Annual Reporton Form 10-K.70Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the shareholders and the Board of Directors of Mylan N.V.:Opinion on the Financial StatementsWe have audited the accompanying consolidated balance sheets of Mylan N.V. and subsidiaries (the "Company") as of December 31, 2018 and 2017, therelated consolidated statements of operations, comprehensive earnings, equity, and cash flows for each of the three years in the period ended December 31,2018, and the related notes and the consolidated financial statement schedule listed in the Index at Item 15 (collectively referred to as the "financialstatements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2018and 2017, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2018 in conformity with accountingprinciples generally accepted in the United States of America.We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company'sinternal control over financial reporting as of December 31, 2018, based on criteria established in Internal Control - Integrated Framework (2013) issued bythe Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 26, 2019, expressed an unqualified opinion on theCompany's internal control over financial reporting.Basis for OpinionThese financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financialstatements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Companyin accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonableassurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing proceduresto assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also includedevaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financialstatements. We believe that our audits provide a reasonable basis for our opinion./s/ DELOITTE & TOUCHE LLPPittsburgh, PennsylvaniaFebruary 26, 2019We have served as the Company's auditor since 1976.71Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the shareholders and the Board of Directors of Mylan N.V.:Opinion on Internal Control over Financial ReportingWe have audited the internal control over financial reporting of Mylan N.V. and subsidiaries (the “Company”) as of December 31, 2018, based on criteriaestablished in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2018, based on criteriaestablished in Internal Control - Integrated Framework (2013) issued by COSO.We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidatedfinancial statements as of and for the year ended December 31, 2018, of the Company and our report dated February 26, 2019, expressed an unqualifiedopinion on those financial statements.Basis for OpinionThe Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness ofinternal control over financial reporting, included in the accompanying Management’s Report on Internal Control over Financial Reporting. Ourresponsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firmregistered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and theapplicable rules and regulations of the Securities and Exchange Commission and the PCAOB.We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonableassurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining anunderstanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operatingeffectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. Webelieve that our audit provides a reasonable basis for our opinion.Definition and Limitations of Internal Control over Financial ReportingA company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reportingand the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal controlover financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairlyreflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permitpreparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are beingmade only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention ortimely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliancewith the policies or procedures may deteriorate./s/ DELOITTE & TOUCHE LLPPittsburgh, PennsylvaniaFebruary 26, 201972Table of ContentsMYLAN N.V. AND SUBSIDIARIESConsolidated Balance Sheets(In millions, except share and per share amounts) December 31, 2018 December 31, 2017ASSETS Assets Current assets: Cash and cash equivalents$388.1 $292.1Accounts receivable, net2,881.0 3,612.4Inventories2,580.2 2,542.7Prepaid expenses and other current assets518.4 766.1Total current assets6,367.7 7,213.3Property, plant and equipment, net2,170.2 2,339.1Intangible assets, net13,664.6 15,245.8Goodwill9,747.8 10,205.7Deferred income tax benefit572.2 496.8Other assets212.4 305.6Total assets$32,734.9 $35,806.3LIABILITIES AND EQUITY Liabilities Current liabilities: Accounts payable$1,617.0 $1,452.5Short-term borrowings1.9 46.5Income taxes payable121.5 112.9Current portion of long-term debt and other long-term obligations699.8 1,808.9Other current liabilities2,147.6 2,964.5Total current liabilities4,587.8 6,385.3Long-term debt13,161.2 12,865.3Deferred income tax liability1,722.0 2,012.4Other long-term obligations1,096.8 1,235.7Total liabilities20,567.8 22,498.7Equity Mylan N.V. shareholders’ equity Ordinary shares — nominal value €0.01 per share as of December 31, 2018 and December 31, 2017 Shares authorized: 1,200,000,000 Shares issued: 539,289,665 and 537,902,426 as of December 31, 2018 and December 31, 20176.0 6.0Additional paid-in capital8,591.4 8,586.0Retained earnings6,010.7 5,644.5Accumulated other comprehensive loss(1,441.3) (361.2) 13,166.8 13,875.3Less: Treasury stock — at cost Ordinary shares: 23,490,867 and 13,695,251 as of December 31, 2018 and December 31, 2017999.7 567.7Total equity12,167.1 13,307.6Total liabilities and equity$32,734.9 $35,806.3See Notes to Consolidated Financial Statements73Table of ContentsMYLAN N.V. AND SUBSIDIARIESConsolidated Statements of Operations(In millions, except per share amounts) Year Ended December 31, 2018 2017 2016Revenues: Net sales$11,268.7 $11,760.0 $10,967.1Other revenues165.2 147.7 109.8Total revenues11,433.9 11,907.7 11,076.9Cost of sales7,432.3 7,124.6 6,379.9Gross profit4,001.6 4,783.1 4,697.0Operating expenses: Research and development704.5 783.3 826.8Selling, general and administrative2,441.0 2,575.7 2,498.5Litigation settlements and other contingencies, net(49.5) (13.1) 672.5Total operating expenses3,096.0 3,345.9 3,997.8Earnings from operations905.6 1,437.2 699.2Interest expense542.3 534.6 454.8Other expense (income), net64.9 (0.4) 122.7Earnings before income taxes298.4 903.0 121.7Income tax (benefit) provision(54.1) 207.0 (358.3)Net earnings352.5 696.0 480.0Earnings per ordinary share attributable to Mylan N.V. ordinary shareholders Basic$0.69 $1.30 $0.94Diluted$0.68 $1.30 $0.92Weighted average ordinary shares outstanding: Basic514.5 534.5 513.0Diluted516.5 536.7 520.5See Notes to Consolidated Financial Statements74Table of ContentsMYLAN N.V. AND SUBSIDIARIESConsolidated Statements of Comprehensive Earnings(In millions) Year Ended December 31, 2018 2017 2016Net earnings$352.5 $696.0 $480.0Other comprehensive (loss) earnings, before tax: Foreign currency translation adjustment(1,125.2) 2,103.9 (507.4)Change in unrecognized (loss) gain and prior service cost related to defined benefit plans(3.8) 3.8 21.4Net unrecognized (loss) gain on derivatives in cash flow hedging relationships(79.2) 52.7 (31.2)Net unrecognized gain (loss) on derivatives in net investment hedging relationships111.6 (238.4) (1.8)Net unrealized (loss) gain on marketable securities(0.1) (6.7) 24.6Other comprehensive (loss) earnings, before tax(1,096.7) 1,915.3 (494.4)Income tax (benefit) provision(24.1) 12.8 5.0Other comprehensive (loss) earnings, net of tax(1,072.6) 1,902.5 (499.4)Comprehensive (loss) earnings$(720.1) $2,598.5 $(19.4)See Notes to Consolidated Financial Statements75Table of ContentsMYLAN N.V. AND SUBSIDIARIESConsolidated Statements of Equity(In millions, except share amounts) AdditionalPaid-InCapital RetainedEarnings AccumulatedOtherComprehensiveLoss NoncontrollingInterest TotalEquity Ordinary Shares Treasury Stock Shares Cost Shares Cost Balance at December 31, 2015491,928,095 $5.5 $7,128.6 $4,462.1 1,311,193 $(67.5) $(1,764.3) $1.4 $9,765.8Net earnings— — — 480.0 — — — — 480.0Other comprehensive loss, net of tax— — — — — — (499.4) — (499.4)Issuance of restricted stock and stockoptions exercised, net1,283,580 13.6 — — — — 13.6Share-based compensation expense— — 88.9 — — — — — 88.9Taxes related to the net share settlement ofequity awards— — (14.2) — — — — — (14.2)Tax benefit of stock option plans— — 1.2 — — — — — 1.2Shares issued for warrant settlement16,979,984 0.2 (0.2) — — — — — —Issuance of ordinary shares to purchaseMeda26,447,632 0.3 1,281.4 — — — — — 1,281.7Balance at December 31, 2016536,639,291 $6.0 $8,499.3 $4,942.1 1,311,193 $(67.5) $(2,263.7) $1.4 $11,117.6Net earnings— $— $— $696.0 — $— $— $— $696.0Other comprehensive earnings, net of tax— — — — — — 1,902.5 — 1,902.5Issuance of restricted stock and stockoptions exercised, net1,263,135 — 17.8 — — — — — 17.8Share-based compensation expense— — 74.7 — — — — — 74.7Ordinary share repurchase— — — — 12,384,058 (500.2) — — (500.2)Taxes related to the net share settlement ofequity awards— — (5.8) — — — — — (5.8)Other— — — 6.4 — — — (1.4) 5.0Balance at December 31, 2017537,902,426 $6.0 $8,586.0 $5,644.5 13,695,251 $(567.7) $(361.2) $— $13,307.6Net earnings— $— $— $352.5 — $— $— $— $352.5Other comprehensive loss, net of tax— — — — — — (1,072.6) — (1,072.6)Ordinary share repurchase— — — — 9,795,616 (432.0) — — (432.0)Share-based compensation (income)expense— — (3.3) — — — — — (3.3)Issuance of restricted stock and stockoptions exercised, net1,387,239 — 17.7 — — — — — 17.7Taxes related to the net share settlement ofequity awards— — (9.0) — — — — — (9.0)Cumulative effect of the adoption of newaccounting standards— — — 13.7 — — (7.5) — 6.2Balance at December 31, 2018539,289,665 $6.0 $8,591.4 $6,010.7 23,490,867 $(999.7) $(1,441.3) $— $12,167.1See Notes to Consolidated Financial Statements76Table of ContentsMYLAN N.V. AND SUBSIDIARIESConsolidated Statements of Cash Flows(In millions) Year Ended December 31, 2018 2017 2016Cash flows from operating activities: Net earnings$352.5 $696.0 $480.0Adjustments to reconcile net earnings to net cash provided by operating activities: Depreciation and amortization2,109.9 1,805.8 1,523.0Deferred income tax benefit(264.3) (111.4) (609.5)Litigation settlements and other contingencies, net(31.6) (40.1) 597.7Unrealized losses on acquisition-related foreign currency derivatives— — 128.6Loss from equity method investments78.7 58.0 112.8Share-based compensation (income) expense(3.3) 74.7 88.9Write off of financing fees2.7 3.2 35.8Other non-cash items286.1 261.0 499.4Changes in operating assets and liabilities: Accounts receivable340.1 (162.2) (131.8)Inventories(547.6) (129.5) (279.3)Trade accounts payable220.3 14.4 87.7Income taxes(23.9) 15.2 37.5Other operating assets and liabilities, net(177.9) (420.3) (523.6)Net cash provided by operating activities2,341.7 2,064.8 2,047.2Cash flows from investing activities: Cash paid for acquisitions, net of cash acquired(65.9) (167.0) (6,481.9)Capital expenditures(252.1) (275.9) (390.4)Payments for product rights and other, net(943.5) (620.3) (360.2)Cash paid for Meda's unconditional deferred payment— — (308.0)Settlement of acquisition-related foreign currency derivatives— — (128.6)Proceeds from sale of assets and subsidiaries29.3 86.7 —Purchase of marketable securities(63.4) (96.5) (30.2)Proceeds from the sale of marketable securities85.2 96.6 21.5Net cash used in investing activities(1,210.4) (976.4) (7,677.8)Cash flows from financing activities: Proceeds from issuance of long-term debt2,577.9 876.1 11,752.2Payments of long-term debt(3,165.2) (2,232.7) (6,296.3)Payments of financing fees(21.4) (10.1) (112.6)Change in short-term borrowings, net(44.4) (2.9) 40.8Purchase of ordinary shares(432.0) (500.2) —Proceeds from exercise of stock options17.8 17.8 13.8Taxes paid related to net share settlement of equity awards(10.1) (7.4) (17.5)Contingent consideration payments(11.9) (26.1) (35.5)Acquisition of noncontrolling interest(0.6) (7.5) (1.1)Other items, net(1.0) (0.1) 0.8Net cash (used in) provided by financing activities(1,090.9) (1,893.1) 5,344.6Effect on cash of changes in exchange rates(21.0) 27.6 (9.6)Net increase (decrease) in cash, cash equivalents and restricted cash19.4 (777.1) (295.6)Cash, cash equivalents and restricted cash — beginning of period369.9 1,147.0 1,442.6Cash, cash equivalents and restricted cash — end of period$389.3 $369.9 $1,147.0Supplemental disclosures of cash flow information — Non-cash transactions: Contingent consideration$— $4.0 $16.0Ordinary shares issued for acquisition$— $— $1,281.7Cash paid during the period for: Income taxes$228.6 $285.7 $285.6Interest$460.8 $474.0 $357.2See Notes to Consolidated Financial Statements77Table of ContentsMylan N.V. and SubsidiariesNotes to Consolidated Financial Statements1.Nature of OperationsMylan N.V. and its subsidiaries (collectively, the “Company,” “Mylan,” “our” or “we”) are engaged in the global development, licensing,manufacture, marketing and distribution of generic, branded generic, brand-name and over-the-counter (“OTC”) pharmaceutical products for resale by othersand active pharmaceutical ingredients (“API”) through three reportable segments on a geographic basis, North America, Europe and Rest of World. Our NorthAmerica segment comprises our operations in the United States (“U.S.”) and Canada. Our Europe segment encompasses our operations across 35 countrieswithin the region, including France, Italy, Germany, the United Kingdom (the “U.K.”) and Spain. Our Rest of World segment reflects our operations in morethan 120 countries, including our operations in Japan, Australia, China, Brazil, Russia, India, South Africa, and certain markets in the Middle East andSoutheast Asia. Our API business is conducted through Mylan Laboratories Limited (“Mylan India”), which is included within our Rest of World segment.2.Summary of Significant Accounting PoliciesPrinciples of Consolidation. The Consolidated Financial Statements include the accounts of Mylan and those of its wholly owned and majority-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Investments in equity method affiliates are recordedat cost and adjusted for the Company’s share of the affiliates’ cumulative results of operations, capital contributions and distributions. Noncontrollinginterests in the Company’s subsidiaries are generally recorded net of tax as net earnings attributable to noncontrolling interests.Use of Estimates in the Preparation of Financial Statements. The preparation of financial statements, in conformity with accounting principlesgenerally accepted in the U.S. (“U.S. GAAP”), requires management to make estimates and assumptions that affect the reported amounts of assets andliabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Because of the uncertaintyinherent in such estimates, actual results could differ from those estimates.Foreign Currencies. The Consolidated Financial Statements are presented in U.S. Dollars, the reporting currency of Mylan. Statements of Operationsand Cash Flows of all of the Company’s subsidiaries that have functional currencies other than U.S. Dollars are translated at a weighted average exchange ratefor the period for inclusion in the Consolidated Statements of Operations and Cash Flows, whereas assets and liabilities are translated at the end of the periodexchange rates for inclusion in the Consolidated Balance Sheets. Translation differences are recorded directly in shareholders’ equity as foreign currencytranslation adjustments. Gains or losses on transactions denominated in a currency other than the subsidiaries’ functional currency, which arise as a result ofchanges in foreign currency exchange rates, are recorded in the Consolidated Statements of Operations.Cash and Cash Equivalents. Cash and cash equivalents are comprised of highly liquid investments with an original maturity of three months or lessat the date of purchase.Debt and Equity Securities. On January 1, 2018, the Company adopted Accounting Standards Update 2016-01, Financial Instruments—Overall(Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”) which requires all equity securities to bemeasured at fair value with changes recognized through net income (loss). Debt securities classified as available-for-sale are recorded at fair value, with netunrealized gains and losses, net of income taxes, reflected in accumulated other comprehensive loss as a component of shareholders’ equity. Net realizedgains and losses on sales of available-for-sale debt securities are computed on a specific security basis and are included in other expense, net, in theConsolidated Statements of Operations. Debt securities, and marketable equity securities prior to January 1, 2018, classified as trading securities are valuedusing quoted stock prices from public exchanges, the quoted market price from broker or dealer quotations or transparent pricing sources at the reportingdate. Realized and unrealized gains and losses are included in other expense, net, in the Consolidated Statements of Operations.Concentrations of Credit Risk. Financial instruments that potentially subject the Company to credit risk consist principally of interest-bearinginvestments, derivatives and accounts receivable.Mylan invests its excess cash in high-quality, liquid money market instruments, principally overnight deposits and highly rated money marketfunds. The Company maintains deposit balances at certain financial institutions in excess of federally insured amounts. Periodically, the Company reviewsthe creditworthiness of its counterparties to derivative78Table of Contentstransactions, and it does not expect to incur a loss from failure of any counterparties to perform under agreements it has with such counterparties.Inventories. Inventories are stated at the lower of cost or market, with cost principally determined by the first-in, first-out method. Provisions forpotentially obsolete or slow-moving inventory, including pre-launch inventory, are made based on our analysis of product dating, inventory levels, historicalobsolescence and future sales forecasts. Included as a component of cost of sales is expense related to the net realizable value of inventories.Property, Plant and Equipment. Property, plant and equipment are stated at cost less accumulated depreciation. Depreciation is computed andrecorded on a straight-line basis over the assets’ estimated service lives (3 to 18 years for machinery and equipment and other fixed assets and 15 to 39 yearsfor buildings and improvements). Capitalized software is included in property, plant and equipment and is amortized over estimated useful lives ranging from3 to 7 years.Intangible Assets and Goodwill. Intangible assets are stated at cost less accumulated amortization. Amortization is generally recorded on a straight-line basis over estimated useful lives ranging from 3 to 20 years. The Company periodically reviews the estimated useful lives of intangible assets and makesadjustments when events indicate that a shorter life is appropriate.The Company accounts for acquired businesses using the acquisition method of accounting in accordance with the provisions of the FinancialAccounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 805, which requires that the assets acquired and liabilities assumed berecorded at the date of acquisition at their respective fair values. The cost to acquire a business is allocated to the underlying net assets of the acquiredbusiness in proportion to their respective fair values. Amounts allocated to acquired in-process research and development (“IPR&D”) are capitalized at thedate of acquisition and are not amortized. As products in development are approved for sale, amounts are allocated to product rights and licenses andamortized over their estimated useful lives. Finite-lived intangible assets are amortized over the expected life of the asset. Any excess of the purchase priceover the estimated fair values of the net assets acquired is recorded as goodwill.Purchases of developed products and licenses that are accounted for as an asset acquisition are capitalized as intangible assets and amortized over anestimated useful life. IPR&D assets acquired as part of an asset acquisition are expensed immediately if they have no alternative future uses.The Company reviews goodwill for impairment at least annually or more frequently if events or changes in circumstances indicate that the carryingvalue of goodwill may not be recoverable based on management's assessment of the fair value of the Company's reporting units as compared to their relatedcarrying value. Under the authoritative guidance issued by the FASB, we have the option to first assess the qualitative factors to determine whether it is morelikely than not that the fair value of the reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform aquantitative goodwill impairment test. If we determine that it is more likely than not that the fair value of a reporting unit is less than its carrying amount,then the goodwill impairment test is performed. The goodwill impairment test requires the Company to estimate the fair value of the reporting unit and tocompare the fair value of the reporting unit with its carrying amount. If the carrying amount is less than its fair value then there is no impairment recognized.If the carrying value recorded exceeds the fair value calculated, an impairment charge is recorded for the difference. The judgments made in determining theprojected cash flows used to estimate the fair value can materially impact the Company’s financial condition and results of operations.Indefinite-lived intangibles, principally IPR&D, are tested at least annually for impairment or upon the occurrence of a triggering event. Theimpairment test for IPR&D consists of a comparison of the asset’s fair value with its carrying value. Impairment is determined to exist when the fair value isless than the carrying value of the assets being tested in an amount of the difference.Contingent Consideration. Mylan records contingent consideration resulting from business acquisitions at fair value on the acquisition date. Eachreporting period thereafter, the Company revalues these obligations and records increases or decreases in their fair value as a charge (credit) to litigationsettlements and other contingencies, net within the Consolidated Statements of Operations. Changes in the fair value of the contingent considerationobligations can result from adjustments to the discount rates, payment periods and adjustments in the probability of achieving future development steps,regulatory approvals, market launches, sales targets and profitability. These fair value measurements represent Level 3 measurements, as they are based onsignificant inputs not observable in the market.Significant judgment is employed in determining the assumptions utilized as of the acquisition date and for each subsequent measurement period.Accordingly, changes in the assumptions described above could have a material impact on the Company’s consolidated financial condition and results ofoperations.79Table of ContentsImpairment of Long-Lived Assets. The carrying values of long-lived assets, which include property, plant and equipment and intangible assets withfinite lives, are evaluated periodically in relation to the expected future undiscounted cash flows of the underlying assets and monitored for other potentialtriggering events. The assessment for impairment is based on our ability to recover the carrying value of the long-lived assets or asset grouping by analyzingthe expected future undiscounted pre-tax cash flows specific to the asset or asset grouping. If the carrying amount is greater than the undiscounted cash flows,the Company recognizes an impairment loss for the excess of the carrying amount over the estimated fair value based on the discounted cash flows.Significant management judgment is involved in estimating the recoverability of these assets and is dependent upon the accuracy of theassumptions used in making these estimates, as well as how the estimates compare to the eventual future operating performance of the specific asset or assetgrouping. Any future long-lived assets impairment charges could have a material impact on the Company’s consolidated financial condition and results ofoperations.Short-Term Borrowings. The Company’s subsidiaries in India have working capital facilities with several banks which are secured by its currentassets. Mylan Pharmaceuticals Inc. (“MPI”), a wholly owned subsidiary of the Company, also has a $400 million accounts receivable facility (“ReceivablesFacility”), which will expire in March 2019.Revenue Recognition. On January 1, 2018, the Company adopted ASC Topic 606 Revenue from Contracts with Customers (“ASC 606”) using themodified retrospective method applied to those contracts which were not completed as of the date of adoption. Results for reporting periods beginning onJanuary 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with ASC Topic 605Revenue Recognition (“ASC 605”). Under ASC 605, the Company recognized net sales when title and risk of loss passed to its customers and whenprovisions for estimates, as described below, were reasonably determinable.Under ASC 606, the Company recognizes net revenue for product sales when control of the promised goods or services is transferred to ourcustomers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Revenues are recorded net ofprovisions for variable consideration, including discounts, rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotionalprograms and other sales allowances. Accruals for these provisions are presented in the consolidated financial statements as reductions in determining netsales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). The following briefly describes thenature of our provisions for variable consideration and how such provisions are estimated:•Chargebacks: the Company has agreements with certain indirect customers, such as independent pharmacies, retail pharmacy chains, managed careorganizations, hospitals, nursing homes, governmental agencies and pharmacy benefit managers, which establish contract prices for certain products.The indirect customers then independently select a wholesaler from which to purchase the products at these contracted prices. Alternatively, certainwholesalers may enter into agreements with indirect customers that establish contract pricing for certain products, which the wholesalers provide.Under either arrangement, Mylan will provide credit to the wholesaler for any difference between the contracted price with the indirect party and thewholesaler’s invoice price. Such credits are called chargebacks. The provision for chargebacks is based on expected sell-through levels by ourwholesaler customers to indirect customers, as well as estimated wholesaler inventory levels.•Rebates, promotional programs and other sales allowances: this category includes rebate and other programs to assist in product sales. Theseprograms generally provide that the customer receives credit directly related to the amount of purchases or credits upon the attainment of pre-established volumes. Also included in this category are prompt pay discounts, administrative fees and price adjustments to reflect decreases in theselling prices of products.•Returns: consistent with industry practice, Mylan maintains a return policy that allows customers to return a product, which varies country bycountry in accordance with local practices, generally within a specified period prior (six months) and subsequent (twelve months) to the expirationdate. The Company’s estimate of the provision for returns is generally based upon historical experience with actual returns.•Governmental rebate programs: government reimbursement programs include Medicare, Medicaid, and State Pharmacy Assistance Programsestablished according to statute, regulations and policy. Manufacturers of pharmaceutical products that are covered by the Medicaid program arerequired to pay rebates to each state based on a statutory formula set forth in the Social Security Act. Medicare beneficiaries are eligible to obtaindiscounted prescription drug coverage from private sector providers. In addition, certain states have also implemented supplemental rebate programsthat obligate manufacturers to pay rebates in excess of those required under federal law. Our estimate of these rebates is based on the historical trendsof rebates paid as well as on changes in wholesaler inventory levels and increases or decreases in the level of sales. Also, this provision includesprice reductions that are mandated by law outside of the U.S.80Table of ContentsWholesaler and distributor inventory levels of our products can fluctuate throughout the year due to the seasonality of certain products, the timingof product demand and other factors. Such fluctuations may impact the comparability of our net sales between periods.Consideration received from licenses of intellectual property is recorded as revenue. Royalty or profit share amounts, which are based on sales oflicensed products or technology, are recorded when the customer’s subsequent sales or usages occur. Such consideration is included in other revenue in theConsolidated Statements of Operations.Research and Development. Research and development (“R&D”) expenses are charged to operations as incurred.Income Taxes. Income taxes have been provided for using an asset and liability approach in which deferred income taxes reflect the taxconsequences on future years of events that the Company has already recognized in the financial statements or tax returns. Changes in enacted tax rates orlaws may result in adjustments to the recorded tax assets or liabilities in the period that the new tax law is enacted.Earnings per Ordinary Share. Basic earnings per ordinary share is computed by dividing net earnings attributable to Mylan N.V. ordinaryshareholders by the weighted average number of ordinary shares outstanding during the period. Diluted earnings per ordinary share is computed by dividingnet earnings attributable to Mylan N.V. ordinary shareholders by the weighted average number of ordinary shares outstanding during the period increased bythe number of additional shares that would have been outstanding related to potentially dilutive securities or instruments, if the impact is dilutive.On August 5, 2016, in conjunction with its acquisition of Meda AB (publ.) (“Meda”), the Company issued approximately 26.4 million Mylan N.V.ordinary shares to Meda shareholders. The impact of the issuance of these ordinary shares is included in the calculation of basic earnings per share. Theweighted average impact for the year ended December 31, 2016, was approximately 10.8 million ordinary shares.The Company was authorized to repurchase up to $1 billion of the Company’s ordinary shares under its repurchase program that was previouslyapproved by the Company's Board of Directors and announced on November 16, 2015, but was not obligated to acquire any particular amount of ordinaryshares. During 2018, the Company repurchased approximately 9.8 million ordinary shares at a cost of approximately $432.0 million. In 2017, the Companyrepurchased approximately 12.4 million ordinary shares at a cost of approximately $500.2 million, and in 2016, no ordinary shares were repurchased.On September 15, 2008, concurrent with the sale of $575 million aggregate principal amount of Cash Convertible Notes due 2015, Mylan Inc.entered into convertible note hedge and warrant transactions with certain counterparties. On April 15, 2016, in connection with the expiration and settlementof the warrants, the Company issued approximately 17.0 million Mylan N.V. ordinary shares. The impact of the issuance of these ordinary shares is includedin the calculation of basic earnings per share from the date of issuance. The dilutive impact of the warrants, prior to settlement, is included in the calculationof diluted earnings per ordinary share based upon the average market value of the Company’s ordinary shares during the period as compared to the exerciseprice. For the year ended December 31, 2016, warrants included in the calculation of diluted earnings per ordinary share were 4.9 million.81Table of ContentsBasic and diluted earnings per ordinary share attributable to Mylan N.V. are calculated as follows: Year Ended December 31,(In millions, except per share amounts)2018 2017 2016Basic earnings attributable to Mylan N.V. ordinary shareholders (numerator): Net earnings attributable to Mylan N.V. ordinary shareholders$352.5 $696.0 $480.0Shares (denominator): Weighted average ordinary shares outstanding514.5 534.5 513.0Basic earnings per ordinary share attributable to Mylan N.V. ordinary shareholders$0.69 $1.30 $0.94 Diluted earnings attributable to Mylan N.V. ordinary shareholders (numerator): Net earnings attributable to Mylan N.V. ordinary shareholders$352.5 $696.0 $480.0Shares (denominator): Weighted average ordinary shares outstanding514.5 534.5 513.0Share-based awards and warrants2.0 2.2 7.5Total dilutive shares outstanding516.5 536.7 520.5Diluted earnings per ordinary share attributable to Mylan N.V. ordinary shareholders$0.68 $1.30 $0.92Additional stock awards and restricted ordinary shares were outstanding during the years ended December 31, 2018, 2017 and 2016 but were notincluded in the computation of diluted earnings per ordinary share for each respective period because the effect would be anti-dilutive. Excluded shares alsoinclude certain share-based compensation awards and restricted ordinary shares whose performance conditions had not been fully met. Such excluded sharesand anti-dilutive awards represented 8.9 million, 8.5 million and 7.8 million shares for the years ended December 31, 2018, 2017 and 2016, respectively.Share-Based Compensation. The fair value of share-based compensation is recognized as expense in the Consolidated Statements of Operationsover the vesting period.Derivatives. From time to time the Company may enter into derivative financial instruments (mainly foreign currency exchange forward contracts,interest rate swaps and purchased equity call options) designed to: 1) hedge the cash flows resulting from existing assets and liabilities and transactionsexpected to be entered into over the next 24 months in currencies other than the functional currency, 2) hedge the variability in interest expense on floatingrate debt, 3) hedge the fair value of fixed-rate notes, 4) hedge against changes in interest rates that could impact future debt issuances, 5) hedge cash or sharepayments required on conversion of issued convertible notes, 6) hedge a net investment in a foreign operation, or 7) economically hedge the foreign currencyexposure associated with the purchase price of non-U.S. acquisitions. Derivatives are recognized as assets or liabilities in the Consolidated Balance Sheets attheir fair value. When the derivative instrument qualifies as a cash flow hedge, changes in the fair value are deferred through other comprehensive earnings. Ifa derivative instrument qualifies as a fair value hedge, the changes in the fair value, as well as the offsetting changes in the fair value of the hedged items, aregenerally included in interest expense. When such instruments do not qualify for hedge accounting the changes in fair value are recorded in the ConsolidatedStatements of Operations within other expense, net.Financial Instruments. The Company’s financial instruments consist primarily of short-term and long-term debt, interest rate swaps, forwardcontracts and option contracts. The Company’s financial instruments also include cash and cash equivalents as well as accounts and other receivables andaccounts payable, the fair values of which approximate their carrying values. As a policy, the Company does not engage in speculative or leveragedtransactions.The Company uses derivative financial instruments for the purpose of hedging foreign currency and interest rate exposures, which exist as part ofongoing business operations, or to hedge cash, and have been used to hedge share payments required on conversion of issued convertible notes. In addition,the Company has designated certain long-term debt instruments as net investment hedges. The Company carries derivative instruments on the ConsolidatedBalance Sheets at fair value, determined by reference to market data such as forward rates for currencies, implied volatilities, and interest rate swap yieldcurves. The accounting for changes in the fair value of a derivative instrument depends on whether it has been designated and qualifies as part of a hedgingrelationship and, if so, the reason for holding it.82Table of ContentsRecent Accounting Pronouncements.Accounting Standards Issued Not Yet Adopted In November 2018, the FASB issued Accounting Standards Update 2018-18 (“ASU 2018-18”), Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606. The amendments in ASU 2018-18 make targeted improvements to U.S. GAAP for collaborativearrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should beapplied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in Topic 808 was aligned withthe guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangementis within the scope of Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years.Early adoption is permitted, including adoption in any interim period. The Company is currently assessing the impact of the adoption of this guidance on itsconsolidated financial statements and disclosures.In August 2018, the FASB issued Accounting Standards Update 2018-14 (“ASU 2018-14”), Compensation-Retirement Benefits-Defined BenefitPlans-General (Subtopic 715-20): Disclosure Framework-Changes to the Disclosure Requirements for Defined Benefit Plans. ASU 2018-14 removes certaindisclosures that are not considered cost beneficial, clarifies certain required disclosures and added additional disclosures. The new standard is effective forfiscal years, including interim periods within those fiscal years, beginning after December 15, 2020 with early adoption in any interim period permitted. Theamendments in ASU 2018-14 would need to be applied on a retrospective basis. The Company is currently assessing the impact of the adoption of thisguidance on its consolidated financial statements and disclosures.In August 2018, the FASB issued Accounting Standards Update 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework—Changes tothe Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. The updated guidance iseffective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted for any removed ormodified disclosures. The Company is currently assessing the impact of the adoption of this guidance on its consolidated financial statements anddisclosures. In June 2018, the FASB issued Accounting Standards Update 2018-07, Compensation - Stock Compensation (Topic 718): Improvements toNonemployee Share-Based Payment Accounting, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods andservices from nonemployees. The changes take effect for public companies for fiscal years starting after December 15, 2018, including interim periods withinthat fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of ASC 606. The Company does not believe the impact of theadoption of this guidance will have a material impact on its consolidated financial statements and disclosures.In February 2018, the FASB issued Accounting Standards Update 2018-02, Income Statement - Reporting Comprehensive Income, (Topic 220):Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, which allows a reclassification from accumulated othercomprehensive income to retained earnings for stranded tax effects resulting from the newly enacted federal corporate income tax rate under thecomprehensive tax legislation enacted by the U.S. government on December 22, 2017 commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”).The amount of the reclassification would be the difference between the historical corporate income tax rate and the newly enacted 21% corporate income taxrate. The new standard is effective for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2018 with early adoptionin any interim period permitted. The Company is currently assessing the impact of the adoption of this guidance on its consolidated financial statements anddisclosures.In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases (Topic 842) which supersedes FASB Topic 840, Leases (Topic840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requireslessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively afinanced purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greaterthan twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operatingleases. In July 2018, the FASB issued Accounting Standards Update 2018-10, Codification Improvements to Topic 842 (Leases), and Accounting StandardsUpdate 2018-11, Leases (Topic 842), Targeted Improvements, which provide (i) narrow amendments to clarify how to apply certain aspects of the new leasestandard, (ii) entities with an additional transition method to adopt the new standard, and (iii) lessors with a practical expedient83Table of Contentsfor separating components of a contract. In December 2018, the FASB issued Accounting Standards Update 2018-20, Leases (Topic 842): Narrow-ScopeImprovements for Lessors, which provides certain narrow-scope improvements to Topic 842 as it relates to lessors. All Accounting Standards Updates relatedto Topic 842 will be effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Companyis in the process of finalizing the analysis of its lease portfolio, implementing systems and processes and updating its accounting policies to comply withTopic 842. Based on work completed to date, the Company expects to recognize upon adoption an initial right-of-use asset and lease liability on itsconsolidated balance sheet of approximately $220 million to $260 million.Adoption of New Accounting StandardsIn October 2018, the FASB issued Accounting Standards Update 2018-16 (“ASU 2018-16”), Derivatives and Hedging (Topic 815): Inclusion of theSecured Overnight Financing Rate (“SOFR”) Overnight Index Swap (“OIS”) Rate as a Benchmark Interest Rate for Hedge Accounting Purposes. ASU 2018-16 permits the OIS rate based on SOFR as a U.S. benchmark interest rate for hedge accounting purposes under Topic 815. ASU 2018-16 will be effective forfiscal years, and interim periods within those fiscal years, beginning after December 15, 2018 and is required to be adopted in conjunction with ASU 2017-12(as defined below) on a prospective basis. The impact of the adoption of this guidance did not have a material impact on the Company’s consolidatedfinancial statements and disclosures.In August 2017, the FASB issued Accounting Standards Update 2017-12, Derivatives and Hedging (Topic 815): Targeted Improvements toAccounting for Hedging Activities (“ASU 2017-12”). The objective of this update is to improve the financial reporting of hedging relationships to betterportray the economic results of an entity’s risk management activities in its financial statements. The amendments in this update also make certain targetedimprovements to simplify the application of the hedge accounting guidance in current U.S. GAAP based on feedback received from preparers, auditors, users,and other stakeholders. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years, with earlyadoption permitted, including adoption in any interim period. The Company elected to early adopt this guidance as of January 1, 2018 and applied it on aprospective basis. Upon adoption, the Company recorded a cumulative effect adjustment.In May 2017, the FASB issued Accounting Standards Update 2017-09, Compensation - Stock Compensation (Topic 718): Scope of ModificationAccounting (“ASU 2017-09”), which amends the scope of modification accounting for share-based payment arrangements. ASU 2017-09 provides guidanceon the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accountingunder Topic 718. Specifically, an entity would not apply modification accounting if the fair value, vesting conditions and classification of the awards are thesame immediately before and after the modification. As required, the Company applied the provisions of ASU 2017-09 on a prospective basis as of January 1,2018 and the adoption did not have a material impact on its consolidated financial statements and disclosures.In March 2017, the FASB issued Accounting Standards Update 2017-07, Compensation - Retirement Benefits (Topic 715): Improving thePresentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Cost (“ASU 2017-07”), which requires companies to disaggregate theservice cost component from the other components of net benefit cost and disclose the amount of net benefit cost that is included in the income statement orcapitalized in assets, by line item. This guidance requires companies to report the service cost component in the same line item(s) as other compensation costsand to report other pension-related costs (which include interest costs, amortization of pension-related costs from prior periods and gains or losses on planassets) separately and exclude them from the subtotal of operating income. This guidance also allows only the service cost component to be eligible forcapitalization when applicable. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017.This guidance should be applied retrospectively for the presentation of the service cost component and the other components of net periodic pension costand net periodic postretirement benefit cost in the income statement and prospectively, on and after the effective date, for the capitalization of the servicecost component of net periodic pension cost and net periodic postretirement benefit in assets. The update allows a practical expedient that permits a companyto use the amounts disclosed in its pension and other postretirement plan note for the prior comparative periods as the estimation basis for applying theretrospective presentation requirements. As required, the Company applied the provisions of ASU 2017-07 as of January 1, 2018 and the adoption did nothave a material impact on its consolidated financial statements and disclosures.In November 2016, the FASB issued Accounting Standards Update 2016-18, Statement of Cash Flows (Topic 230) Restricted Cash (“ASU 2016-18”), which requires that the reconciliation of the beginning of period and end of period amounts shown in the statement of cash flows include restricted cashand restricted cash equivalents. If restricted cash is presented separately from cash and cash equivalents on the balance sheet, companies will be required toreconcile the amounts presented on the statement of cash flows to the amounts on the balance sheet. This guidance is effective for fiscal years beginning after84Table of ContentsDecember 15, 2017, and interim periods within those fiscal years. As required, the Company applied the provisions of ASU 2016-18 as of January 1, 2018. Asa result, the change in restricted cash has been excluded from investing activities and included in the change in cash, cash equivalents and restricted cash andthe prior year periods have been recast to reflect the new presentation.In January 2016, the FASB issued ASU 2016-01, which supersedes the current guidance to classify equity securities with readily determinable fairvalues into different categories and requires equity securities to be measured at fair value with changes in the fair value recognized through net income (loss).In February 2018, the FASB issued Accounting Standards Update 2018-03, Technical Corrections and Improvements to Financial Instruments—Overall(Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities, which clarifies the guidance in ASU 2016-01. The standardsare effective for annual and interim periods beginning after December 15, 2017. As required, the Company applied the provisions of ASU 2016-01 as ofJanuary 1, 2018. Upon adoption, the Company recorded a cumulative effect adjustment.In May 2014, the FASB issued Accounting Standards Update 2014-09 (“ASU 2014-09”), Revenue from Contracts with Customers (updated withAccounting Standards Update 2015-14, 2016-08, 2016-10, 2016-12 and 2016-20), which revises accounting guidance on revenue recognition that willsupersede nearly all existing revenue recognition guidance under U.S. GAAP (codified as Topic 606). The core principle of this guidance is that an entityshould recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration which the entity expects toreceive in exchange for those goods or services. This guidance also requires additional disclosure about the nature, amount, timing and uncertainty ofrevenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurredto obtain or fulfill a contract. This guidance is effective for fiscal years beginning after December 15, 2017, and for interim periods within those fiscal years,and can be applied using a full retrospective or modified retrospective approach. The Company adopted this standard and its updates as of January 1, 2018and elected to apply the modified retrospective transition approach. As a result, the Company is recognizing revenue on certain arrangements upon thetransfer of control of product shipments rather than upon sell-through by the customer, and is recording certain costs historically in cost of sales as contrarevenue.The Company elected to apply the following practical expedients and elections in connection with the adoption of ASU 2014-09: i) taxes collectedfrom customers and remitted to government authorities and that are related to the sales of the Company’s products, primarily in Europe, are excluded fromrevenues, and ii) shipping and handling activities are accounted for as fulfillment costs and are recorded in cost of sales. Payment terms related to productsales vary by jurisdiction and customer, but revenue for product sales has not been adjusted for the effects of a financing component as we expect that theperiod between when we transfer control of the product and when we receive payment to be one year or less.The cumulative effect of the changes made to our consolidated January 1, 2018 balance sheet for the adoption of ASU 2014-09, ASU 2016-01 andASU 2017-12 were as follows:(In millions)Balance as ofDecember 31,2017 Adjustments Dueto ASU 2014-09 Adjustments Dueto ASU 2016-01 Adjustments Dueto ASU 2017-12 Balance as ofJanuary 1,2018Consolidated Balance Sheet Assets Prepaid expenses and other current assets$766.1 $9.2 $— $— $775.3 Liabilities Deferred income tax liability2,012.4 3.0 — — 2,015.4 Equity Retained earnings5,644.5 6.2 10.0 (2.5) 5,658.2Accumulated other comprehensive loss(361.2) — (10.0) 2.5 (368.7)85Table of ContentsDuring the fourth quarter of 2018, the Company has revised the cumulative effect of the adoption of ASU 2014-09 which reduced the adjustment tobeginning retained earnings by approximately $6.6 million, net of tax. In accordance with ASU 2014-09, the disclosure of the impact of adoption on ourconsolidated statement of operations and balance sheet was as follows: For the Year Ended December 31, 2018(In millions)As Reported Balances WithoutAdoption of ASC 606 Effect of ChangeIncrease (Decrease)Consolidated Statement of Operations Revenues$11,433.9 $11,588.4 $(154.5)Cost of sales7,432.3 7,593.9 (161.6)Income tax benefit(54.1) (56.4) 2.3Net earnings352.5 347.7 4.8 December 31, 2018(In millions)As Reported Balances WithoutAdoption of ASC 606 Effect of ChangeIncrease (Decrease)Consolidated Balance Sheet Prepaid expenses and other current assets$518.4 $511.3 $7.1Income taxes payable121.5 119.2 2.3Retained earnings6,010.7 6,005.9 4.83.Revenue from Contracts with CustomersRevenue DisaggregationThe following table presents the Company’s net sales by therapeutic franchise for each of our reportable segments for the years ended December 31,2018, 2017, and 2016:(In millions)North America Europe Rest of World TotalYear Ended December 31, 2018 Central Nervous System & Anesthesia$718.5 $877.5 $340.7 $1,936.7Infectious Disease260.8 441.8 826.4 1,529.0Respiratory & Allergy643.2 399.9 208.9 1,252.0Cardiovascular342.4 567.9 170.6 1,080.9Gastroenterology136.4 614.0 364.7 1,115.1Diabetes & Metabolism416.5 252.3 121.3 790.1Dermatology352.2 330.6 95.8 778.6Women’s Health350.7 253.2 104.4 708.3Oncology543.4 78.4 137.1 758.9Immunology49.5 18.7 38.6 106.8Other (1)282.0 323.0 607.3 1,212.3Total$4,095.6 $4,157.3 $3,015.8 $11,268.786Table of Contents(In millions)North America Europe Rest of World TotalYear Ended December 31, 2017 Central Nervous System & Anesthesia$1,057.1 $862.7 $317.0 $2,236.8Infectious Disease200.0 343.2 921.7 1,464.9Respiratory & Allergy709.8 446.3 206.2 1,362.3Cardiovascular454.5 579.8 170.3 1,204.6Gastroenterology183.5 581.0 357.9 1,122.4Diabetes & Metabolism577.7 266.2 103.6 947.5Dermatology529.4 295.3 106.0 930.7Women’s Health331.2 282.7 94.4 708.3Oncology487.4 71.2 148.6 707.2Immunology83.5 10.3 37.6 131.4Other (1)355.5 219.6 368.8 943.9Total$4,969.6 $3,958.3 $2,832.1 $11,760.0(In millions)North America Europe Rest of World TotalYear Ended December 31, 2016 Central Nervous System & Anesthesia$1,105.0 $699.5 $198.9 $2,003.4Infectious Disease184.0 270.4 884.0 1,338.4Respiratory & Allergy1,348.1 261.4 198.2 1,807.7Cardiovascular564.3 473.5 129.6 1,167.4Gastroenterology244.5 485.1 293.8 1,023.4Diabetes & Metabolism638.3 237.7 95.1 971.1Dermatology207.8 134.6 53.8 396.2Women’s Health367.9 151.4 70.9 590.2Oncology613.6 53.0 120.1 786.7Immunology93.6 8.2 32.1 133.9Other (1)262.4 179.0 307.3 748.7Total$5,629.5 $2,953.8 $2,383.8 $10,967.1____________(1) Other consists of numerous therapeutic franchises, none of which individually exceeds 5% of consolidated net sales.Variable Consideration The following table presents a reconciliation of gross sales to net sales by each significant category of variable consideration during the years endedDecember 31, 2018, 2017 and 2016, respectively: Year Ended December 31,(In millions)2018 2017 2016Gross sales$19,588.1 $22,206.1 $21,058.9Gross to net adjustments: Chargebacks(3,352.2) (4,239.5) (4,277.9)Rebates, promotional programs and other sales allowances(4,235.6) (5,281.1) (5,147.9)Returns(261.6) (390.7) (301.7)Governmental rebate programs(470.0) (534.8) (364.3)Total gross to net adjustments$(8,319.4) $(10,446.1) $(10,091.8)Net sales$11,268.7 $11,760.0 $10,967.187Table of ContentsThe following is a rollforward of the categories of variable consideration during 2018:(In millions)Balance atDecember 31,2017 Current ProvisionRelated to SalesMade in theCurrent Period Checks/ CreditsIssued to ThirdParties Effects of ForeignExchange Balance atDecember 31,2018Chargebacks$574.3 $3,352.2 $(3,447.1) $(1.2) $478.2Rebates, promotional programs and other sales allowances1,508.1 4,235.6 (4,526.0) (15.3) 1,202.4Returns472.5 261.6 (292.1) (2.5) 439.5Governmental rebate programs240.3 470.0 (486.6) (1.5) 222.2Total$2,795.2 $8,319.4 $(8,751.8) $(20.5) $2,342.3Accruals for these provisions are presented in the Consolidated Financial Statements as reductions in determining net revenues and in accountsreceivable and other current liabilities. Accounts receivable are presented net of allowances relating to these provisions, which were comprised of thefollowing at December 31, 2018 and 2017, respectively:(In millions)December 31, 2018 December 31, 2017Accounts receivable$1,715.6 $1,977.2Other current liabilities626.7 818.0Total$2,342.3 $2,795.2We have not made and do not anticipate making any significant changes to the methodologies that we use to measure provisions for variableconsideration; however, the balances within these reserves can fluctuate significantly through the consistent application of our methodologies. Historically,we have not recorded in any current period any material amounts related to adjustments made to prior period reserves.4.Acquisitions and Other TransactionsApicore Inc.On October 3, 2017, the Company completed the acquisition of Apicore, Inc. (“Apicore”), a U.S. based developer and manufacturer of API forapproximately $174.9 million, net of cash acquired, which includes estimated contingent consideration of approximately $4.0 million related to thepotential $15.0 million payment contingent on the achievement of certain 2017 financial results of the acquired business. As of December 31, 2017, thecontingent consideration liability was zero as Apicore did not achieve the financial results that would have triggered the contingent consideration payment.The allocation of the $174.9 million purchase price to the assets acquired and liabilities assumed for this business is as follows:(In millions) Current assets (net of cash acquired)$6.5Identified intangible assets121.0Goodwill92.2Other assets1.9Total assets acquired221.6Current liabilities(4.1)Deferred tax liabilities(40.9)Other non-current liabilities(1.7)Net assets acquired$174.988Table of ContentsThe acquisition of Apicore added a diversified portfolio of API products to the Company’s existing portfolio. The identified intangible assets of$121.0 million are comprised of product rights and licenses with a weighted average useful life of seven years and includes IPR&D with a fair value of $9.0million at the date of the acquisition. Significant assumptions utilized in the valuation of identified intangible assets were based on company specificinformation and projections which are not observable in the market and are thus considered Level 3 measurements as defined by U.S. GAAP. The goodwill of$92.2 million arising from the acquisition consisted largely of the value of the employee workforce and the expected value of products to be developed inthe future. All of the goodwill was allocated to the North America segment. None of the goodwill recognized in this transaction is currently expected to bedeductible for income tax purposes. The acquisition did not have a material impact on the Company’s results of operations since the acquisition date or on apro forma basis for the years ended December 31, 2017 and 2016.Meda ABOn February 10, 2016, the Company issued an offer announcement under the Nasdaq Stockholm’s Takeover Rules and the Swedish Takeover Actsetting forth a public offer to the shareholders of Meda to acquire all of the outstanding shares of Meda (the “Offer”), with an enterprise value, including thenet debt of Meda, of approximately Swedish krona (“SEK” or “kr”) 83.6 billion (based on a SEK/USD exchange rate of 8.4158) or $9.9 billion atannouncement. On August 2, 2016, the Company announced that the Offer was accepted by Meda shareholders holding an aggregate of approximately 343million shares, representing approximately 94% of the total number of outstanding Meda shares, as of July 29, 2016, and the Company declared the Offerunconditional. On August 5, 2016, settlement occurred with respect to the Meda shares duly tendered by July 29, 2016 and, as a result, Meda became acontrolled subsidiary of the Company. Pursuant to the terms of the Offer, each Meda shareholder that duly tendered Meda shares into the Offer received atsettlement (1) in respect of 80% of the number of Meda shares tendered by such shareholder, 165kr in cash per Meda share, and (2) in respect of the remaining20% of the number of Meda shares tendered by such shareholder, 0.386 of the Company’s ordinary shares per Meda share (subject to treatment of fractionalshares as described in the offer document published on June 16, 2016). The non-tendered shares were required to be acquired for cash through a compulsoryacquisition proceeding, in accordance with the Swedish Companies Act (Sw. aktiebolagslagen (2005:551)). The compulsory acquisition proceeding priceaccrued interest as required by the Swedish Companies Act. Meda’s shares were delisted from the Nasdaq Stockholm exchange on August 23, 2016.On November 1, 2016, the Company made an offer to the remaining Meda shareholders to tender all their Meda shares for cash consideration of161.31kr per Meda share to provide such remaining shareholders with an opportunity to sell their shares in Meda to the Company in advance of theautomatic acquisition of their shares for cash in connection with the compulsory acquisition proceeding. At the end of November 2016, Mylan completed theacquisition of approximately 19 million Meda shares duly tendered for aggregate cash consideration of approximately $330.3 million. In March 2017, theCompany received full legal ownership to the remaining non-tendered Meda shares in exchange for a cash payment of approximately $71.6 million, equal tothe uncontested portion of the compulsory acquisition price plus statutory interest, and the Company’s arrangement of a customary bank guarantee to securethe payment of any additional cash consideration that may be awarded to the former Meda shareholders in the compulsory acquisition proceeding. In October2017, the arbitration tribunal awarded a price of 163.07kr per Meda share, plus statutory interest of 1.5% per annum, to the former Meda shareholders subjectto the compulsory acquisition proceeding. On November 15, 2017 Mylan paid an additional approximately $0.9 million plus interest to such former Medashareholders and, in accordance with Swedish law, the fees of the arbitrators and costs of other parties to the compulsory acquisition proceeding. The bankguarantee was released on February 27, 2018, definitively concluding the compulsory acquisition proceeding.On August 5, 2016, the total purchase price was approximately $6.92 billion, net of cash acquired, which includes cash consideration paid ofapproximately $5.28 billion, the issuance of approximately 26.4 million Mylan N.V. ordinary shares at a fair value of approximately $1.28 billion based onthe closing price of the Company’s ordinary shares on August 5, 2016, as reported by the NASDAQ Global Select Stock Market (“NASDAQ”), and anassumed liability of approximately $431.0 million related to the compulsory acquisition proceeding of the non-tendered Meda shares. In accordance withU.S. GAAP, the Company used the acquisition method of accounting to account for this transaction. Under the acquisition method of accounting, the assetsacquired and liabilities assumed in the transaction have been recorded at their respective estimated fair values at the acquisition date. Acquisition relatedcosts of approximately $182 million were incurred during the year ended December 31, 2016, which were recorded as components of R&D expense, selling,general and administrative expense (“SG&A”), interest expense and other expense, net in the Consolidated Statements of Operations. These costs includedapproximately $128.6 million of losses on non-designated foreign currency forward and option contracts entered into in order to economically hedge theSEK purchase price of the Offer and approximately $45.2 million of financing fees related to the termination of a 2016 bridge credit agreement entered intoin connection with the Meda acquisition.89Table of ContentsThe allocation of the $6.92 billion purchase price to the assets acquired and liabilities assumed for Meda is as follows:(In millions) Current assets (excluding inventories and net of cash acquired)$473.3Inventories468.1Property, plant and equipment177.5Identified intangible assets8,060.7Goodwill3,684.6Other assets8.8Total assets acquired12,873.0Current liabilities(1,110.8)Long-term debt, including current portion(2,864.6)Deferred tax liabilities(1,613.2)Pension and other postretirement benefits(322.3)Other noncurrent liabilities(41.0)Net assets acquired$6,921.1The acquisition of Meda created a more diversified and expansive portfolio of branded and generic medicines along with a strong and growingportfolio of OTC products. The combined company has a balanced global footprint with significant scale in key geographic markets, particularly the U.S. andEurope. The acquisition of Meda also expanded our presence in key emerging markets, including, China, Russia, Turkey, and Mexico, and in countries inSouth East Asia, and the Middle East, which complemented Mylan’s existing presence in India, Brazil and Africa (including South Africa). The Companyrecorded a step-up in the fair value of inventory of approximately $107 million at the acquisition date, which was fully amortized as of December 31, 2016.The identified intangible assets of $8.06 billion are comprised of product rights and licenses that have a weighted average useful life of 20 years.Significant assumptions utilized in the valuation of identified intangible assets were based on company specific information and projections which are notobservable in the market and are thus considered Level 3 measurements as defined by U.S. GAAP. The goodwill of $3.68 billion arising from the acquisitionconsisted largely of the value of the employee workforce and the expected value of products to be developed in the future. Approximately $3.4 billion ofgoodwill recognized was allocated to the Europe segment, with approximately $290 million allocated to the North America segment, and approximately $6million allocated to the Rest of World segment. None of the goodwill recognized in this transaction is currently expected to be deductible for income taxpurposes.The settlement of the Offer constituted an Acceleration Event (as defined in the Rottapharm Agreement referred to below) under the Sale andPurchase Agreement, dated as of July 30, 2014 (the “Rottapharm Agreement”), among Fidim S.r.l., Meda Pharma S.p.A and Meda, the occurrence of whichaccelerated an unconditional deferred purchase price payment of approximately $308 million (€275 million) relating to Meda’s acquisition of RottapharmS.p.A. which otherwise would have been payable in January 2017. The amount was paid during the year ended December 31, 2016.The operating results of Meda have been included in the Company’s Consolidated Statements of Operations since the acquisition date. The totalrevenues of Meda for the period from the acquisition date to December 31, 2016 were $833.9 million and the net loss, net of tax, was $208.7 million, whichincludes the effects of the purchase accounting adjustments and acquisition related costs.90Table of ContentsRenaissance Topicals BusinessOn June 15, 2016, the Company completed the acquisition of the non-sterile, topicals-focused business (the “Topicals Business”) of RenaissanceAcquisition Holdings, LLC (“Renaissance”) for approximately $1.0 billion in cash at closing, including amounts deposited into escrow for potentialcontingent payments, subject to customary adjustments. The Topicals Business provided the Company with a complementary portfolio of commercial andpipeline products and an established U.S. sales and marketing infrastructure targeting dermatologists. The Topicals Business also provided an integratedmanufacturing and development platform. In accordance with U.S. GAAP, the Company used the acquisition method of accounting to account for thistransaction. Under the acquisition method of accounting, the assets acquired and liabilities assumed in the transaction were recorded at their respectiveestimated fair values at the acquisition date. The U.S. GAAP purchase price was $972.7 million, which includes estimated contingent consideration ofapproximately $16 million related to the potential $50 million payment contingent on the achievement of certain 2016 financial targets. The contingentconsideration was resolved in the fourth quarter of 2017 for a net payment of approximately $40 million and the Company recognized a charge of $23.5million included as a component of litigation settlements and other contingencies, net in the Company’s Consolidated Statements of Operations for the yearended December 31, 2017.The allocation of the $972.7 million purchase price to the assets acquired and liabilities assumed for the Topicals Business is as follows:(In millions) Current assets (excluding inventories)$57.7Inventories74.2Property, plant and equipment54.8Identified intangible assets467.0In-process research and development275.0Goodwill318.6Other assets0.1Total assets acquired1,247.4Current liabilities(74.2)Deferred tax liabilities(194.6)Other noncurrent liabilities(5.9)Net assets acquired$972.7The acquisition of the Topicals Business broadened the Company’s dermatological portfolio. The amount allocated to IPR&D represents an estimateof the fair value of purchased in-process technology for research projects that, as of the closing date of the acquisition, had not reached technologicalfeasibility and had no alternative future use. The fair value of IPR&D of $275.0 million was based on the excess earnings method, which utilizes forecasts ofexpected cash inflows (including estimates for ongoing costs) and other contributory charges. A discount rate of 12.5% was utilized to discount net cashinflows to present values. IPR&D is accounted for as an indefinite-lived intangible asset and will be subject to impairment testing until completion orabandonment of the projects. Upon successful completion and launch of each product, the Company will make a determination of the estimated useful life ofthe individual IPR&D asset and amounts will be allocated to product rights and licenses in intangible assets. The acquired IPR&D projects are in variousstages of completion and the estimated costs to complete these projects total approximately $15 million, which is expected to be incurred through 2022.There are risks and uncertainties associated with the timely and successful completion of the projects included in IPR&D, and no assurances can be given thatthe underlying assumptions used to estimate the fair value of IPR&D will not change or the timely completion of each project to commercial success willoccur.The identified intangible assets of $467.0 million are comprised of $454.0 million of product rights and licenses that have a weighted average usefullife of 14 years and $13.0 million of contract manufacturing agreements that have a weighted average useful life of five years. Significant assumptionsutilized in the valuation of identified intangible assets were based on company specific information and projections which are not observable in the marketand are thus considered Level 3 measurements as defined by U.S. GAAP.The goodwill of $318.6 million arising from the acquisition consisted largely of the value of the employee workforce and the expected value ofproducts to be developed in the future. All of the goodwill was assigned to the North America91Table of Contentssegment. None of the goodwill recognized in this transaction is currently expected to be deductible for income tax purposes. Acquisition related costs ofapproximately $3.6 million were incurred during the year ended December 31, 2016 related to this transaction, which were recorded as a component of SG&Ain the Consolidated Statements of Operations. The acquisition did not have a material impact on the Company’s results of operations since the acquisitiondate or on a pro forma basis for the year ended December 31, 2016.Unaudited Pro Forma Financial ResultsThe following table presents supplemental unaudited pro forma information for the acquisition of Meda as if it had occurred on January 1, 2015. Theunaudited pro forma results reflect certain adjustments related to past operating performance and acquisition accounting adjustments, such as increasedamortization expense based on the fair value of assets acquired, the impact of transaction costs and the related income tax effects. The unaudited pro formaresults do not include any anticipated synergies which may be achievable subsequent to acquisition of Meda. Accordingly, the unaudited pro forma resultsare not necessarily indicative of the results that actually would have occurred, nor are they indicative of the future operating results of Mylan N.V.(Unaudited, in millions, except per share amounts)Year EndedDecember 31,2016Total revenues$12,376.0Net earnings$560.6Earnings per ordinary share: Basic$1.06Diluted$1.05Weighted average ordinary shares outstanding: Basic528.7Diluted536.2Other TransactionsOn December 1, 2018, the Company and certain subsidiaries of Aspen Pharmacare Holdings Limited entered into an agreement for Mylan todistribute a portfolio of prescription and OTC products in Australia and New Zealand. The agreement includes an option for Mylan to purchase the rights tothe portfolio for approximately $135 million.On August 31, 2018, the Company completed an agreement with certain subsidiaries of Novartis AG (“Novartis”) to purchase the worldwide rightsto their global cystic fibrosis products consisting of the TOBI Podhaler® and TOBI® solution. Tobramycin is the standard of care for treatment ofpseudomonas aeruginosa, a leading driver of infection in cystic fibrosis. These products further strengthen our existing presence in cystic fibrosis, especiallywith our Creon Franchise in Europe, Australia, Japan and Canada. The asset acquisition allows us to further extend our respiratory franchise into rare/orphandisease indications and broaden our portfolio into dry powdered inhalers and nebulized products. Tobi Podhaler™ is manufactured using a proprietaryPulmosphere technology for which we have acquired exclusive rights for use, hence we expect a high barrier for generic entry. Under the terms of the agreement, Novartis is owed fixed consideration of $463.0 million which consists of $240.0 million which was paid at closingand deferred payments of $130.0 million included in other current liabilities and $93.0 million included in other long-term obligations, due in 2019 and2020, respectively. Novartis is also eligible to receive a contingent payment of up to $20 million. The Company also entered into a supply agreement withNovartis to purchase the products for up to three years from the date of closing. The Company has recorded a liability of approximately $91 million related tosupply obligations.The Company accounted for this transaction as an asset acquisition and recognized an intangible asset for the product rights of $574.8 million. Theintangible asset is being amortized over a useful life of 10 years.On February 28, 2018, the Company and Revance Therapeutics, Inc. (“Revance”) entered into a collaboration agreement (the “RevanceCollaboration Agreement”) pursuant to which the Company and Revance will collaborate exclusively, on a world-wide basis (excluding Japan), to develop,manufacture and commercialize a biosimilar to the branded biologic product (onabotulinumtoxinA) marketed as BOTOX®.92Table of ContentsUnder the Revance Collaboration Agreement, the Company will be primarily responsible for (a) clinical development activities outside of NorthAmerica (excluding Japan) (the “ex-U.S. Mylan territories”), (b) regulatory activities, and (c) commercialization for any approved product. Revance will beprimarily responsible for (a) non-clinical development activities, (b) clinical development activities in North America, and (c) manufacturing and supply ofclinical drug substance and drug product; Revance will be solely responsible for an initial portion of non-clinical development costs. The remaining portionof any non-clinical development costs and clinical development costs for obtaining approval in the U.S. and Europe will be shared equally between theparties, and the Company will be responsible for all other clinical development costs and commercialization expenses. Upon closing, Revance received anon-refundable upfront payment of $25.0 million. In addition, under the Revance Collaboration Agreement, Revance can receive potential developmentmilestone payments of up to $100.0 million, in the aggregate, upon the achievement of specified clinical and regulatory milestones and potential tiered salesmilestones of up to $225.0 million. In addition, Mylan will pay Revance royalties on sales of the biosimilar in the ex-U.S. Mylan territories. The Companyaccounted for this transaction as an asset acquisition of IPR&D and the total upfront payment was expensed as a component of R&D expense during the yearended December 31, 2018.During the year ended December 31, 2018, the Company completed four agreements to acquire certain intellectual property rights and marketingauthorizations for products that were in the development stage, including agreements with Fujifilm Kyowa Kirin Biologics Co., Ltd. (“FKB”), Mapi PharmaLtd., and Lupin Limited. The Company also completed the acquisition of intellectual property rights and marketing authorizations related to acommercialized product in certain rest of world markets for $220.0 million, of which $160.0 million was paid at closing and $20 million was paid in thefourth quarter of 2018, with the remaining amount due in 2019 and included in other current liabilities. The Company is accounting for these transactions asasset acquisitions and a useful life of five years is being used to amortize the asset related to the commercialized product. The Company recorded expense ofapproximately $53.7 million as a component of R&D expense related to non-refundable upfront payments for agreements for products in development duringthe year ended December 31, 2018. Certain of the agreements include additional development and commercial milestones.As part of the Meda acquisition, the Company acquired the in-licensed rights to Betadine in certain European markets. These rights were set toexpire on December 31, 2017. Under the licensing agreement, Meda had a binding option to acquire a perpetual license for the rights to Betadine undercertain conditions. In October 2017, the Company finalized an agreement to acquire the perpetual license. An estimated liability of approximately $300million for the purchase of these rights was accrued for on the Meda acquisition opening balance sheet. On January 2, 2018, the Company paid the amountsdue to acquire the perpetual license.On December 25, 2017, the Company entered into an agreement to reacquire certain intellectual property rights and marketing authorizationsrelated to a product commercialized in Japan for $90.0 million, which was paid in 2018. The Company accounted for this transaction as an asset acquisitionand the asset is being amortized over a useful life of five years.On November 30, 2017, the Company entered into an exclusive license and supply agreement with Natco Pharma Limited for API related to theCompany’s Glatiramer Acetate Injection 40 mg/mL product for $22.5 million paid at closing and $29.5 million due through 2020. The license grants theCompany the exclusive right to license, market and sell the product in North America and certain other territories. The intangible asset recognized totaled$52 million and was amortized over a useful life of 15 months.On September 29, 2017, the Company completed the acquisition of intellectual property rights and marketing authorizations related to a product incertain markets for $40 million. The Company accounted for this transaction as an asset acquisition and the asset is being amortized over a useful life of fiveyears.On June 19, 2017, the Company completed the acquisition of a portfolio of four generic pharmaceutical products in the U.S. The acquisition pricewas $256.7 million and the Company accounted for this transaction as an asset acquisition. The intangible asset recognized totaled $252.5 million with theremaining assets primarily consisting of receivables. The intangible asset was being amortized over a useful life of seven years through December 31, 2018.Subsequently, the Company has revised the remaining useful life to four years.On June 2, 2017, the Company completed the acquisition of additional intellectual property rights and marketing authorizations in certain rest ofworld markets for a product that the Company previously licensed in certain European markets. The acquisition price was $128.0 million and the Companyaccounted for this transaction as an asset acquisition. The intangible asset is being amortized over a useful life of five years.93Table of ContentsOn March 29, 2017, the Company announced that it had completed its acquisition of the global rights to the Cold-EEZE® brand cold remedy linefrom ProPhase Labs, Inc. for approximately $50 million in cash. The Company accounted for this transaction as an asset acquisition and the asset is beingamortized over a useful life of 15 years.On February 14, 2017, the Company entered into a joint development and marketing agreement for a respiratory product that resulted inapproximately $50 million in R&D expense during the year ended December 31, 2017.During the year ended December 31, 2016, the Company entered into an agreement to acquire a marketed pharmaceutical product for an upfrontpayment of approximately $57.9 million in cash. The Company accounted for this transaction as an asset acquisition and is amortizing the product over aweighted useful life of five years.5.Balance Sheet ComponentsSelected balance sheet components consist of the following:Cash and restricted cash(In millions)December 31, 2018 December 31, 2017Cash and cash equivalents$388.1 $292.1Restricted cash, included in prepaid expenses and other current assets1.2 77.8Cash, cash equivalents and restricted cash$389.3 $369.9Accounts receivable, net(In millions)December 31,2018 December 31,2017Trade receivables, net$2,416.5 $3,173.1Other receivables464.5 439.3Accounts receivable, net$2,881.0 $3,612.4Total allowances for doubtful accounts were $98.2 million and $75.3 million at December 31, 2018 and 2017, respectively. Mylan performsongoing credit evaluations of its customers and generally does not require collateral. Approximately 21% and 35% of the accounts receivable balancesrepresent amounts due from three customers at December 31, 2018 and 2017, respectively.Inventories(In millions)December 31,2018 December 31,2017Raw materials$955.7 $895.5Work in process369.9 384.7Finished goods1,254.6 1,262.5Inventories$2,580.2 $2,542.7Inventory reserves totaled $228.2 million and $171.0 million at December 31, 2018 and 2017, respectively. Included as a component of cost of salesis expense related to the net realizable value of inventories of $300.5 million, $229.3 million and $195.7 million for the years ended December 31, 2018,2017 and 2016, respectively.94Table of ContentsPrepaid expenses and other current assets(In millions)December 31, 2018 December 31, 2017Prepaid expenses$130.6 $119.8Restricted cash1.2 77.8Available-for-sale fixed income securities25.0 31.5Fair value of financial instruments33.8 88.9Equity securities32.5 79.1Other current assets295.3 369.0Prepaid expenses and other current assets$518.4 $766.1Prepaid expenses consists primarily of prepaid rent, insurance and other individually insignificant items. At December 31, 2017, restricted cashprincipally related to amounts deposited in escrow for contingent consideration payments related to the Company’s acquisition of Agila Specialties PrivateLimited (“Agila”). During the year ended December 31, 2018, approximately $51.0 million of restricted cash was remitted to Strides Arcolab Limited(“Strides Arcolab”) as part of the final settlement of the Agila contingent consideration and $23.5 million to Merck KGaA for the remittance of certainincome tax refunds.Property, plant and equipment, net(In millions)December 31,2018 December 31,2017Machinery and equipment$2,421.2 $2,414.5Buildings and improvements1,182.3 1,191.7Construction in progress239.7 252.9Land and improvements131.3 143.1Gross property, plant and equipment3,974.5 4,002.2Accumulated depreciation1,804.3 1,663.1Property, plant and equipment, net$2,170.2 $2,339.1Capitalized software costs included on our Consolidated Balance Sheets were $112.0 million and $143.0 million, net of accumulated depreciation,at December 31, 2018 and 2017, respectively. The Company periodically reviews the estimated useful lives of assets and makes adjustments whenappropriate. Depreciation expense was approximately $279.5 million, $287.6 million and $259.4 million for the years ended December 31, 2018, 2017 and2016, respectively.Other assets(In millions)December 31,2018 December 31,2017Equity method investments, clean energy investments$138.7 $226.0Other long-term assets73.7 79.6Other assets$212.4 $305.6Accounts payable(In millions)December 31,2018 December 31,2017Trade accounts payable$1,123.2 $976.0Other payables493.8 476.5Accounts payable$1,617.0 $1,452.595Table of ContentsOther current liabilities(In millions)December 31,2018 December 31,2017Accrued sales allowances$626.7 $818.0Payroll and employee benefit liabilities399.7 404.6Legal and professional accruals, including litigation accruals128.1 241.1Contingent consideration158.3 167.8Restructuring62.3 91.5Equity method investments, clean energy investments45.1 56.7Accrued interest62.4 42.3Fair value of financial instruments29.4 31.1Other635.6 1,111.4Other current liabilities$2,147.6 $2,964.5In the fourth quarter of 2018, the Company announced the voluntary recall of valsartan and certain combination valsartan medicines in variouscountries due to the detection of trace amounts of an impurity, N-nitrosodiethylamine (“NDEA”) contained in the API valsartan, USP, manufactured byMylan India. The impact of this recall on the Company’s consolidated financial statements for the year ended December 31, 2018 was approximately $22.6million, primarily related to recall costs and inventory reserves. Depending on the scope of regulatory actions, and severity of the impurity, the Companymay face additional loss of revenues and profits and incur contractual or other litigation costs. There can be no assurance that future costs related to the recallwill not exceed amounts recorded.Other long-term obligations(In millions)December 31,2018 December 31,2017Employee benefit liabilities$397.7 $408.2Equity method investments, clean energy investments100.3 171.8Contingent consideration197.0 285.9Tax contingencies162.1 237.7Other239.7 132.1Other long-term obligations$1,096.8 $1,235.76.Equity Method InvestmentsThe Company has three equity method investments in limited liability companies that own refined coal production plants (the “clean energyinvestments”), whose activities qualify for income tax credits under Section 45 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”). TheCompany does not consolidate these entities as we have determined that we are not the primary beneficiary of these entities and do not have the power toindividually direct the activities of these entities. Accordingly, these investments are accounted for under the equity method of accounting. For each of theclean energy investments, the Company has entered into notes payable with the respective project sponsor, which in part will be paid to the sponsor ascertain production levels are met.During 2018, the Company and a project sponsor agreed to terminate two previous investments. Under the termination agreements, the Companyreturned its ownership interest in the projects to the sponsor and in exchange the Company will have no further obligations with respect to the notes payablefor these projects.Also, during 2018, the Company entered into amended agreements related to the three remaining investments. These amendments effectively reducethe amount of expected future variable debt payments to the respective project sponsor.During the year ended December 31, 2017 as a result of a decline in the current and expected future production levels at certain of the facilities, theCompany impaired its investment balance and other assets by approximately $47.0 million and reduced the related long-term obligations for theseinvestments by approximately $89.0 million resulting in a net gain of $42.0 million which was recognized as a component of other expense, net in theConsolidated Statement of Operations.96Table of ContentsThe carrying values and respective balance sheet locations of the Company’s clean energy investments were as follows at December 31, 2018 and2017, respectively:(In millions)December 31, 2018 December 31, 2017Other assets$138.7 $226.0Total liabilities145.4 228.5Included in other current liabilities45.1 56.7Included in other long-term obligations100.3 171.8Summarized financial information, in the aggregate, of the Company’s equity method investments on a 100% basis as of December 31, 2018 and2017 and for the years ended December 31, 2018, 2017 and 2016 are as follows:(In millions)December 31, 2018 December 31, 2017Current assets$36.6 $56.4Noncurrent assets2.3 18.2Total assets38.9 74.6Current liabilities32.8 56.1Noncurrent liabilities1.7 3.6Total liabilities34.5 59.7Net assets$4.4 $14.9 Year Ended December 31,(In millions)2018 2017 2016Total revenues$483.3 $473.0 $589.4Gross (loss) profit(21.1) (12.8) (13.2)Operating and non-operating expense21.9 22.3 22.2Net loss$(43.0) $(35.1) $(35.4)The Company’s net losses from equity method investments include amortization expense related to the excess of the cost basis of the Company’sinvestment to the underlying assets of each individual investee. For the years ended December 31, 2018, 2017 and 2016, the Company’s share of the net lossof the equity method investments was $78.7 million, $58.0 million, and $112.8 million, respectively, which was recognized as a component of other expense,net in the Consolidated Statements of Operations. The Company recognizes the income tax credits and benefits from the clean energy investments as part ofits provision for income taxes.97Table of Contents7.Goodwill and Other Intangible AssetsThe changes in the carrying amount of goodwill for the years ended December 31, 2018 and 2017 are as follows:(In millions)North AmericaSegment Europe Segment Rest of WorldSegment TotalBalance at December 31, 2016: Goodwill$3,990.4 $3,859.1 $1,767.4 $9,616.9Accumulated impairment losses(385.0) — — (385.0) 3,605.4 3,859.1 1,767.4 9,231.9Acquisitions92.2 — — 92.2Reclassifications (1)(200.1) 382.2 (182.1) —Measurement period adjustments— 7.7 — 7.7Divestiture— (1.3) — (1.3)Foreign currency translation52.1 719.4 103.7 875.2 3,549.6 4,967.1 1,689.0 10,205.7Balance at December 31, 2017: Goodwill3,934.6 4,967.1 1,689.0 10,590.7Accumulated impairment losses(385.0) — — (385.0) 3,549.6 4,967.1 1,689.0 10,205.7Foreign currency translation(41.7) (309.7) (106.5) (457.9) 3,507.9 4,657.4 1,582.5 9,747.8Balance at December 31, 2018 Goodwill3,892.9 4,657.4 1,582.5 10,132.8Accumulated impairment losses(385.0) — — (385.0) $3,507.9 $4,657.4 $1,582.5 $9,747.8____________(1) The reclassifications relate to the allocation of goodwill for the Meda acquisition.Intangible assets consist of the following components at December 31, 2018 and 2017:(In millions)WeightedAverage Life(Years) Cost AccumulatedAmortization Net Book ValueDecember 31, 2018 Product rights, licenses and other (1)15 $20,264.1 $7,225.1 $13,039.0In-process research and development 625.6 — 625.6 $20,889.7 $7,225.1 $13,664.6December 31, 2017 Product rights, licenses and other (1)15 $20,338.7 $5,906.1 $14,432.6In-process research and development 813.2 — 813.2 $21,151.9 $5,906.1 $15,245.8____________(1) Represents amortizable intangible assets. Other intangibles consist principally of customer lists and contractual rights.98Table of ContentsProduct rights and licenses are primarily comprised of the products marketed at the time of acquisition. These product rights and licenses relate tonumerous individual products, the net book value of which, by therapeutic franchise, is as follows:(In millions)December 31, 2018 December 31, 2017Central Nervous System and Anesthesia$2,148.9 $2,453.7Dermatology2,125.7 2,393.0Gastroenterology1,790.9 2,050.0Diabetes and Metabolism1,232.4 1,425.6Cardiovascular1,541.9 1,779.5Respiratory and Allergy2,084.1 1,769.5Infectious Disease596.0 494.8Oncology206.0 380.1Women's Healthcare315.1 371.4Immunology258.8 301.5Other (1) 694.9 970.1 $12,994.7 $14,389.2____________(1)Other consists of numerous therapeutic classes, none of which individually exceeds 5% of total product rights and licenses.Amortization expense and intangible asset impairment charges, which are included as a component of amortization expense, which is classifiedprimarily within cost of sales in the Consolidated Statements of Operations, for the years ended December 31, 2018, 2017 and 2016 was as follows: Year ended December 31,(In millions)2018 2017 2016Intangible asset amortization expense$1,606.4 $1,437.4 $1,195.3IPR&D intangible asset impairment charges117.7 74.6 49.9Finite-lived intangible asset impairment charges106.3 6.2 18.4Total intangible asset amortization expense (including impairment charges)$1,830.4 $1,518.2 $1,263.6The assessment for impairment of finite-lived intangibles is based on our ability to recover the carrying value of the long-lived assets or assetgrouping by analyzing the expected future undiscounted pre-tax cash flows specific to the asset or asset grouping. If the carrying amount is greater than theundiscounted cash flows, the Company recognizes an impairment loss for the excess of book value over fair value based on the discounted cash flows.Significant management judgment is involved in estimating the recoverability of these assets and is dependent upon the accuracy of theassumptions used in making these estimates, as well as how the estimates compare to the eventual future operating performance of the specific asset or assetgrouping. The fair value of finite-lived intangible assets was calculated as the present value of the estimated future net cash flows using a market rate ofreturn. The assumptions inherent in the estimated future cash flows include, among other things, the impact of the current competitive environment andfuture market expectations. Discount rates ranging between 9.0% and 10.0% were utilized in the valuations performed during the years ended December 31,2018, 2017 and 2016. At December 31, 2018 and 2017, the Company’s finite-lived intangible assets totaled $13.04 billion and $14.43 billion, respectively.Any future long-lived assets impairment charges could have a material impact on the Company’s consolidated financial condition and results of operations.The Company’s IPR&D assets are tested at least annually for impairment, but they may be tested whenever certain impairment indicators are present.Impairment is determined to exist when the fair value of IPR&D assets, which was based upon updated forecasts and commercial development plans, is lessthan the carrying value of the assets being tested. The fair value of IPR&D was calculated as the present value of the estimated future net cash flows using amarket rate of return. The assumptions inherent in the estimated future cash flows include, among other things, the impact of changes to the developmentprograms, the projected development and regulatory time frames and the current competitive environment. Discount rates99Table of Contentsranging between 9.5% and 13.0%, 8.4% and 10.5%, and 8.5% and 11.9% were utilized in the valuations performed during the years ended December 31,2018, 2017 and 2016 respectively.The fair value of both IPR&D and finite-lived intangible assets was determined based upon detailed valuations employing the income approachwhich utilized Level 3 inputs, as defined in Note 8 Financial Instruments and Risk Management. Changes to any of the Company’s assumptions includingchanges to or abandonment of development programs, regulatory timelines, discount rates or the competitive environment related to the assets could lead tofuture material impairment charges.In December 2011, the Company completed the acquisition of the exclusive worldwide rights to develop, manufacture and commercialize a genericequivalent to GlaxoSmithKline’s Advair® Diskus and Seretide® Diskus incorporating Pfizer Inc.’s (“Pfizer”) proprietary dry powder inhaler deliveryplatform (the “respiratory delivery platform”). The Company accounted for this transaction as a purchase of a business and utilized the acquisition method ofaccounting. As of December 31, 2018, the Company has an IPR&D asset of $347.2 million and related contingent consideration liability of $336.5 million.The Company performed an analysis and valuation of the IPR&D asset and the fair value of the related contingent consideration liability using a discountedcash flow model. The model contained certain key assumptions including: the expected product launch date, the number of competitors, the timing ofcompetition and a discount factor based on an industry specific weighted average cost of capital. Based on the analysis performed, the Company determinedthat the fair value of the IPR&D asset was substantially in excess of its carrying value, and the asset was not impaired at December 31, 2018. Additionally, afair value adjustment was required for the related contingent consideration liability resulting in a gain of approximately $44.0 million for the year endedDecember 31, 2018 based upon changes to assumptions relating to the timing of the product launch along with other competitive and market factors. The fairvalue of the contingent consideration liability was determined based upon detailed valuations employing the income approach which utilized Level 3inputs, as defined in Note 8 - Financial Instruments and Risk Management. On January 30, 2019, the Company received FDA approval of WixelaTM InhubTM(fluticasone propionate and salmeterol inhalation powder, USP), the first generic of GlaxoSmithKline’s Advair Diskus®. The commercial launch of theWixelaTM InhubTM occurred in February 2019. The Company expects to reclassify the IPR&D asset of $347.2 million to product rights and licenses in thefirst quarter of 2019. Market conditions and other factors may result in significant future changes in the projections and assumptions utilized in thediscounted cash flow model, which could lead to material adjustments to the amounts recorded for intangible assets and contingent consideration.The Company has performed its annual goodwill impairment test as of April 1, 2018 on a quantitative basis for its four reporting units, NorthAmerica Generics, North America Brands, Europe and Rest of World. In estimating each reporting unit’s fair value, the Company performed an extensivevaluation analysis, utilizing both income and market-based approaches, except for the North America Brands reporting unit where the fair value wasestimated utilizing the income approach. The determination of the fair value of the reporting units requires the Company to make significant estimates andassumptions that affect the reporting unit’s expected future cash flows. These estimates and assumptions, utilizing Level 3 inputs, primarily include, but arenot limited to, market multiples, control premiums, the discount rate, terminal growth rates, operating income before depreciation and amortization, andcapital expenditures forecasts. Due to the inherent uncertainty involved in making these estimates, actual results could differ from those estimates. Inaddition, changes in underlying assumptions, especially as it relates to the key assumptions detailed, could have a significant impact on the fair value of thereporting units.As of the date of our annual impairment test, the allocation of the Company’s total goodwill was as follows: North America Generics $2.89 billion,North America Brands $0.66 billion, Europe $4.97 billion and Rest of World $1.80 billion. The fair value of the North America Generics, North AmericaBrands and Rest of World reporting units was substantially in excess of the respective unit’s carrying value. For the Europe reporting unit, the estimated fairvalue exceeded its carrying value by approximately $800.0 million or 6.0%. The excess fair value for the Europe reporting unit is consistent with the result ofthe Company’s 2017 annual impairment test. As it relates to the income approach for the Europe reporting unit at April 1, 2018, the Company forecasted cashflows for the next 5 years. During the forecast period, the revenue compound annual growth rate was approximately 3.5%. A terminal value year wascalculated with a 2.0% revenue growth rate applied. The discount rate utilized was 9.0% and the estimated tax rate was 24.0%. Under the market-basedapproach, we utilized an estimated range of market multiples of 9.0 to 10.5 times EBITDA plus a control premium of 15.0%. If all other assumptions are heldconstant, a reduction in the terminal value growth rate by 2.0% or an increase in discount rate by 1.5% would result in an impairment charge for the Europereporting unit.100Table of ContentsIntangible asset amortization expense for the years ended December 31, 2019 through 2023 is estimated to be as follows:(In millions) 2019$1,70320201,54420211,46220221,39220239678.Financial Instruments and Risk ManagementThe Company is exposed to certain financial risks relating to its ongoing business operations. The primary financial risks that are managed by usingderivative instruments are foreign currency risk and interest rate risk.Foreign Currency Risk ManagementIn order to manage certain foreign currency risks, the Company enters into foreign exchange forward contracts to mitigate risk associated withchanges in spot exchange rates of mainly non-functional currency denominated assets or liabilities. The foreign exchange forward contracts are measured atfair value and reported as current assets or current liabilities on the Consolidated Balance Sheets. Any gains or losses on the foreign exchange forwardcontracts are recognized in earnings in the period incurred in the Consolidated Statements of Operations.The Company has also entered into forward contracts to hedge forecasted foreign currency denominated sales from certain international subsidiaries.These contracts are designated as cash flow hedges to manage foreign currency transaction risk and are measured at fair value and reported as current assets orcurrent liabilities on the Consolidated Balance Sheets. Any changes in the fair value of designated cash flow hedges are deferred in accumulated othercomprehensive earnings (“AOCE”) and are reclassified into earnings when the hedged item impacts earnings.Net Investment HedgesThe Company may hedge the foreign currency risk associated with certain net investment positions in foreign subsidiaries by either borrowingdirectly in foreign currencies and designating all or a portion of the foreign currency debt as a hedge of the applicable net investment position or enteringinto foreign currency swaps that are designated as hedges of net investments.The Company designated certain Euro borrowings as a hedge of its investment in certain Euro-functional currency subsidiaries in order to manageforeign currency translation risk. Borrowings designated as net investment hedges are marked-to-market using the current spot exchange rate as of the end ofthe period, with gains and losses included in the foreign currency translation component of AOCE until the sale or substantial liquidation of the underlyingnet investments. In addition, the Company manages the related foreign exchange risk of the Euro borrowings not designated as net investment hedgesthrough certain Euro denominated financial assets and forward currency swaps.The following table summarizes the principal amounts of the Company’s outstanding Euro borrowings and the notional amounts of the Euroborrowings designated as net investment hedges: Notional Amount Designated as a NetInvestment Hedge(in millions) Principal Amount December 31, 2018 December 31, 20172.250% Euro Senior Notes due 2024 €1,000.0 €1,000.0 €1,000.03.125% Euro Senior Notes due 2028 750.0 750.0 750.01.250% Euro Senior Notes due 2020 750.0 104.0 104.02.125% Euro Senior Notes due 2025 500.0 500.0 —Floating Rate Euro Notes due 2020 500.0 — —Total €3,500.0 €2,354.0 €1,854.0101Table of ContentsInterest Rate Risk ManagementThe Company enters into interest rate swaps in order to manage interest rate risk associated with the Company’s fixed-rate and floating-rate debt.Interest rate swaps that meet specific accounting criteria are accounted for as fair value or cash flow hedges. All derivative instruments used to manageinterest rate risk are measured at fair value and reported as current assets or current liabilities in the Consolidated Balance Sheets. For fair value hedges, thechanges in the fair value of both the hedging instrument and the underlying debt obligations are included in interest expense. For cash flow hedges, thechange in fair value of the hedging instrument is deferred through AOCE and is reclassified into earnings when the hedged item impacts earnings.Cash Flow Hedging RelationshipsThe Company’s interest rate swaps designated as cash flow hedges fix the interest rate on a portion of the Company’s variable-rate debt or hedge partof the Company’s interest rate exposure associated with the variability in the future cash flows attributable to changes in interest rates. Any changes in fairvalue are included in earnings or deferred through AOCE, depending on the nature and effectiveness of the offset. Any ineffectiveness in a cash flow hedgingrelationship is recognized immediately in earnings in the Consolidated Statements of Operations.Following the acquisition of Meda, the Company designated certain interest rate swaps with a notional amount of €750 million as cash flow hedges.In the fourth quarter of 2016, the Company repaid the related debt instrument and terminated these swaps.In anticipation of issuing fixed-rate debt, the Company may use treasury rate locks or forward starting interest rate swaps that are designated as cashflow hedges. In September 2015, the Company entered into a series of forward starting swaps to hedge against changes in interest rates related to future debtissuances. These swaps were designated as cash flow hedges of expected future issuances of long-term bonds. The Company executed $500 million ofnotional value swaps with an effective date of June 2016 and an additional $500 million of notional value swaps with an effective date of November 2016.Both sets of swaps had a maturity of ten years. During the second quarter of 2016, the Company issued $2.25 billion in an aggregate principal amount of3.950% Senior Notes due 2026 (the “2026 Senior Notes”) and the Company terminated these swaps. As a result of this termination, the Company recordedlosses of $64.9 million in AOCE, which are being amortized over the life of the 2026 Senior Notes.Fair Value Hedging RelationshipsThe Company's interest rate swaps designated as fair value hedges convert the fixed rate on a portion of the Company's fixed-rate senior notes to avariable rate. Any changes in the fair value of these derivative instruments, as well as the offsetting change in fair value of the portion of the fixed-rate debtbeing hedged, is included in interest expense. In December 2013, the Company entered into interest rate swaps with a notional value of $750 million thatwere designated as hedges of the Company’s 3.125% Senior Notes due 2023. The variable rate was 2.86% at December 31, 2018. The total notional amountof the Company’s interest rate swaps on fixed-rate debt was $750 million as of December 31, 2018 and 2017.Credit Risk ManagementThe Company regularly reviews the creditworthiness of its financial counterparties and does not expect to incur a significant loss from the failure ofany counterparties to perform under any agreements. The Company is not subject to any obligations to post collateral under derivative instrument contracts.Certain derivative instrument contracts entered into by the Company are governed by master agreements, which contain credit-risk-related contingentfeatures that would allow the counterparties to terminate the contracts early and request immediate payment should the Company trigger an event of defaulton other specified borrowings. The Company records all derivative instruments on a gross basis in the Consolidated Balance Sheets. Accordingly, there areno offsetting amounts that net assets against liabilities.102Table of ContentsThe Effect of Derivative Instruments on the Consolidated Balance SheetsFair Values of Derivative InstrumentsDerivatives Designated as Hedging Instruments Asset Derivatives December 31, 2018 December 31, 2017(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair ValueInterest rate swapsPrepaid expenses and othercurrent assets $3.6 Prepaid expenses and othercurrent assets $16.2Foreign currency forward contractsPrepaid expenses and othercurrent assets — Prepaid expenses and othercurrent assets 63.4Total $3.6 $79.6 Liability Derivatives December 31, 2018 December 31, 2017 Balance Sheet Location Fair Value Balance Sheet Location Fair ValueForeign currency forward contractsOther current liabilities $12.1 Other current liabilities $— $12.1 $—The Effect of Derivative Instruments on the Consolidated Balance SheetsFair Values of Derivative InstrumentsDerivatives Not Designated as Hedging Instruments Asset Derivatives December 31, 2018 December 31, 2017(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair ValueForeign currency forward contractsPrepaid expenses and othercurrent assets $30.2 Prepaid expenses and othercurrent assets $9.3Total $30.2 $9.3 Liability Derivatives December 31, 2018 December 31, 2017(In millions)Balance Sheet Location Fair Value Balance Sheet Location Fair ValueForeign currency forward contractsOther current liabilities $17.3 Other current liabilities $31.1Total $17.3 $31.1103Table of ContentsThe Effect of Derivative Instruments on the Consolidated Statements of OperationsDerivatives in Fair Value Hedging Relationships Location of Loss Recognized inEarnings on DerivativesAmount of Loss Recognized in Earnings on Derivatives Year Ended December 31,(In millions)2018 2017 2016Interest rate swapsInterest expense$(12.6) $(10.0) $(10.0)Total$(12.6) $(10.0) $(10.0) Location of Gain Recognized inEarnings on Hedged ItemsAmount of Gain Recognized in Earnings on HedgingItems Year Ended December 31,(In millions)2018 2017 20162023 Senior Notes (3.125% coupon)Interest expense$12.6 $10.0 $10.0Total$12.6 $10.0 $10.0The Effect of Derivative Instruments on the Consolidated Statements of Comprehensive EarningsDerivatives in Net Investment Hedging Relationships Amount of Gain or (Loss) Recognized in AOCE (Net ofTax) on Derivatives (Effective Portion) Year Ended December 31,(In millions)2018 2017 2016Foreign currency borrowings and forward contracts$108.9 $(238.4) $(1.4)Total$108.9 $(238.4) $(1.4)The Effect of Derivative Instruments on the Consolidated Statements of Comprehensive EarningsDerivatives in Cash Flow Hedging Relationships Amount of (Loss) or Gain Recognized in AOCE (Net ofTax) on Derivatives (Effective Portion) Year Ended December 31,(In millions)2018 2017 2016Foreign currency forward contracts$(46.6) $28.1 $(27.5)Interest rate swaps— — (38.7)Total$(46.6) $28.1 $(66.2)The Effect of Derivative Instruments on the Consolidated Statements of OperationsDerivatives in Cash Flow Hedging Relationships Location of Gain or (Loss) Reclassified fromAOCE into Earnings (Effective Portion)Amount of Gain or (Loss) Reclassified from AOCE intoEarnings (Effective Portion) Year Ended December 31,(In millions)2018 2017 2016Foreign currency forward contractsNet sales$6.2 $1.1 $(44.3)Interest rate swapsInterest expense(7.7) (7.3) (8.7)Total$(1.5) $(6.2) $(53.0)104Table of Contents Location of Loss Excluded from theAssessment of Hedge EffectivenessAmount of Loss Excluded from the Assessment of HedgeEffectiveness Year Ended December 31,(In millions)2018 2017 2016Foreign currency forward contractsOther expense, net$— $(3.3) $33.5Total$— $(3.3) $33.5At December 31, 2018, the Company expects that approximately $58.0 million of pre-tax net losses on cash flow hedges will be reclassified fromAOCE into earnings during the next twelve months.The Effect of Derivative Instruments on the Consolidated Statements of OperationsDerivatives Not Designated as Hedging Instruments Location of Gain or (Loss) Recognized inEarnings on DerivativesAmount of Gain or (Loss) Recognized in Earnings onDerivatives Year Ended December 31,(In millions)2018 2017 2016Foreign currency option and forward contractsOther expense, net$34.8 $47.7 $(104.5)Total$34.8 $47.7 $(104.5)Fair Value MeasurementFair value is based on the price that would be received from the sale of an identical asset or paid to transfer an identical liability in an orderlytransaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, a fair valuehierarchy has been established that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are describedbelow:Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair valuehierarchy gives the highest priority to Level 1 inputs.Level 2: Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities.Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3inputs.In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use ofunobservable inputs to the extent possible, as well as considers counterparty credit risk in its assessment of fair value.105Table of ContentsFinancial assets and liabilities carried at fair value are classified in the tables below in one of the three categories described above: December 31, 2018(In millions)Level 1 Level 2 Level 3 TotalRecurring fair value measurements Financial AssetsCash equivalents: Money market funds$71.0 $— $— $71.0Total cash equivalents71.0 — — 71.0Equity securities: Exchange traded funds31.7 — — 31.7Marketable securities0.8 — — 0.8Total equity securities32.5 — — 32.5Available-for-sale fixed income investments: Corporate bonds— 9.9 — 9.9U.S. Treasuries— 9.4 — 9.4Agency mortgage-backed securities— 1.6 — 1.6Asset backed securities— 3.2 — 3.2Other— 0.9 — 0.9Total available-for-sale fixed income investments— 25.0 — 25.0Foreign exchange derivative assets— 30.2 — 30.2Interest rate swap derivative assets— 3.6 — 3.6Total assets at recurring fair value measurement$103.5 $58.8 $— $162.3Financial LiabilitiesForeign exchange derivative liabilities$— $29.4 $— $29.4Contingent consideration— — 355.3 355.3Total liabilities at recurring fair value measurement$— $29.4 $355.3 $384.7106Table of Contents December 31, 2017(In millions)Level 1 Level 2 Level 3 TotalRecurring fair value measurements Financial AssetsCash equivalents: Money market funds$8.4 $— $— $8.4Total cash equivalents8.4 — — 8.4Equity securities: Exchange traded funds33.9 — — 33.9Marketable securities45.2 — — 45.2Total equity securities79.1 — — 79.1Available-for-sale fixed income investments: Corporate bonds— 16.5 — 16.5U.S. Treasuries— 7.4 — 7.4Agency mortgage-backed securities— 4.1 — 4.1Asset backed securities— 2.1 — 2.1Other— 1.4 — 1.4Total available-for-sale fixed income investments— 31.5 — 31.5Foreign exchange derivative assets— 72.7 — 72.7Interest rate swap derivative assets— 16.2 — 16.2Total assets at recurring fair value measurement$87.5 $120.4 $— $207.9Financial LiabilitiesForeign exchange derivative liabilities$— $31.1 $— $31.1Contingent consideration— — 453.7 453.7Total liabilities at recurring fair value measurement$— $31.1 $453.7 $484.8For financial assets and liabilities that utilize Level 2 inputs, the Company utilizes both direct and indirect observable price quotes, including theLIBOR yield curve, foreign exchange forward prices, and bank price quotes. For the years ended December 31, 2018 and 2017, there were no transfersbetween Level 1 and 2 of the fair value hierarchy. Below is a summary of valuation techniques for Level 1 and Level 2 financial assets and liabilities:•Cash equivalents — valued at observable net asset value prices.•Equity securities, exchange traded funds — valued at the active quoted market prices from broker or dealer quotations or transparent pricingsources at the reporting date. Unrealized gains and losses attributable to changes in fair value are included in other expense, net, in theConsolidated Statements of Operations.•Equity securities, marketable securities — valued using quoted stock prices from public exchanges at the reporting date. Unrealized gainsand losses attributable to changes in fair value are included in other expense, net, in the Consolidated Statements of Operations.•Available-for-sale fixed income investments — valued at the quoted market prices from broker or dealer quotations or transparent pricingsources at the reporting date. Unrealized gains and losses attributable to changes in fair value, net of income taxes, are included inaccumulated other comprehensive loss as a component of shareholders’ equity.•Interest rate swap derivative assets and liabilities — valued using the LIBOR/EURIBOR yield curves at the reporting date. Counterparties tothese contracts are highly rated financial institutions.•Foreign exchange derivative assets and liabilities — valued using quoted forward foreign exchange prices and spot rates at the reportingdate. Counterparties to these contracts are highly rated financial institutions.107Table of ContentsContingent ConsiderationThe fair value measurement of contingent consideration is determined using Level 3 inputs. The Company’s contingent consideration represents acomponent of the total purchase consideration for the respiratory delivery platform, the acquisitions of Agila, certain female healthcare businesses from FamyCare Limited (such businesses “Jai Pharma Limited”) and the Topicals Business and certain other acquisitions. The measurement is calculated usingunobservable inputs based on the Company’s own assumptions. For the respiratory delivery platform, Jai Pharma Limited and certain other acquisitions,significant unobservable inputs in the valuation include the probability and timing of future development and commercial milestones and future profitsharing payments. When valuing the contingent consideration related to the respiratory delivery platform and Jai Pharma Limited, the value of theobligations is derived from a probability assessment based on expectations of when certain milestones or profit share payments occur which are discountedusing a market rate of return. At December 31, 2018 and 2017, discount rates ranging from 2.1% to 11.0% were utilized in the valuations. Significant changesin unobservable inputs could result in material changes to the contingent consideration liability.A rollforward of the activity in the Company’s fair value of contingent consideration from December 31, 2016 to December 31, 2018 is as follows:(In millions)Current Portion(1) Long-TermPortion (2) Total ContingentConsiderationBalance at December 31, 2016$256.9 $307.7 $564.6Payments(77.3) (0.2) (77.5)Reclassifications27.0 (27.0) —Accretion— 25.9 25.9Fair value gain (3)(38.8) (20.5) (59.3)Balance at December 31, 2017$167.8 $285.9 $453.7Payments(82.9) — (82.9)Reclassifications62.1 (62.1) —Accretion— 19.8 19.8Fair value loss (gain) (3)11.3 (46.6) (35.3)Balance at December 31, 2018$158.3 $197.0 $355.3____________(1) Included in other current liabilities on the Consolidated Balance Sheets.(2) Included in other long-term obligations on the Consolidated Balance Sheets.(3) Included in litigation settlements and other contingencies, net in the Consolidated Statements of Operations.2017 Changes to Contingent Consideration: During the year ended December 31, 2017, the Company recorded a fair value gain of $93.5 millionrelated to the respiratory delivery platform contingent consideration partially offset by fair value losses of $9.9 million related to Jai Pharma Limitedcontingent consideration and $23.5 million related to the Topicals Business contingent consideration. In addition, the Company made payments ofapproximately $13.7 million related to the Agila contingent consideration, a net payment of $40 million to resolve the Topicals Business contingentconsideration and a payment of approximately $20.0 million related to the Jai Pharma Limited contingent consideration.2018 Changes to Contingent Consideration: During the year ended December 31, 2018, the Company recorded a fair value gain of $44.0 millionrelated to the respiratory delivery platform contingent consideration partially offset by fair value losses of $8.6 million related to the Jai Pharma Limitedcontingent consideration. In addition, the Company made payments of approximately $51.0 million to resolve the Agila contingent consideration and a netpayment of $30.0 million to resolve the Jai Pharma Limited contingent consideration.The Company expects to incur approximately $15 million to $20 million of non-cash accretion expense related to the increase in the net presentvalue of the contingent consideration liabilities in 2019.Although the Company has not elected the fair value option for financial assets and liabilities, any future transacted financial asset or liability willbe evaluated for the fair value election.108Table of ContentsAvailable-for-Sale SecuritiesThe amortized cost and estimated fair value of available-for-sale fixed income securities, included in prepaid expenses and other current assets, wereas follows:(In millions)Cost GrossUnrealizedGains GrossUnrealizedLosses FairValueDecember 31, 2018 (1) Debt securities$24.8 $0.2 $— $25.0 $24.8 $0.2 $— $25.0December 31, 2017 Debt securities$31.5 $— $— $31.5Equity securities29.5 16.9 (1.2) 45.2 $61.0 $16.9 $(1.2) $76.7(1) Equity securities are no longer classified as available-for-sale as of January 1, 2018 as a result of the adoption of ASU 2016-01. Refer to Note 2Summary of Significant Accounting Policies for additional information.Maturities of available-for-sale debt securities at fair value as of December 31, 2018, were as follows:(In millions) Mature within one year$3.1Mature in one to five years13.4Mature in five years and later8.5 $25.09.DebtShort-Term Borrowings(In millions)December 31, 2018 December 31, 2017Receivables Facility$— $45.0Other1.9 1.5Short-term borrowings$1.9 $46.5Receivables FacilityThe Company has a $400 million Receivables Facility, which expires on March 25, 2019.Under the terms of the Receivables Facility, our subsidiary, MPI, sells certain accounts receivable to Mylan Securitization LLC (“MylanSecuritization”), a wholly-owned special purpose entity which in turn sells a percentage ownership interest in the receivables to financial institutions andcommercial paper conduits sponsored by financial institutions. MPI is the servicer of the receivables under the Receivables Facility. Purchases under theReceivables Facility will be repaid as accounts receivable are collected, with new purchases being advanced as new accounts receivable are originated byMPI. Mylan Securitization’s assets have been pledged to The Bank of Tokyo-Mitsubishi UFJ, Ltd., as agent, in support of its obligations under theReceivables Facility. Any amounts outstanding under the facility are recorded as borrowings and the underlying receivables will continue to be included inaccounts receivable, net, in the Consolidated Balance Sheets of the Company.The Receivables Facility contains requirements relating to the performance of the accounts receivable and covenants related to the Company withwhich the Company was compliant as of December 31, 2018. As of December 31, 2018 and 2017, the Company had $322.0 million and $1.04 billion,respectively, of accounts receivable balances sold to Mylan Securitization.109Table of ContentsCommercial Paper ProgramOn July 27, 2018, the Company established an unsecured commercial paper program (the “Commercial Paper Program”) pursuant to which MylanInc. may issue short-term, unsecured commercial paper notes (the “CP Notes”) that are guaranteed by the Company pursuant to the exemption fromregistration contained in Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), which replaced Mylan N.V.’s existing commercialpaper program established June 8, 2017 (the “Existing Commercial Paper Program”) on substantially identical terms to the Existing Commercial PaperProgram. Amounts available under the Commercial Paper Program may be borrowed, repaid and re-borrowed from time to time, with the aggregate principalamount of the commercial paper notes outstanding under the Commercial Paper Program at any time not to exceed $1.65 billion. The Company’s 2018Revolving Facility (as defined below) will be available to pay the CP Notes, if necessary. The maturities of the CP Notes will vary but will not exceed 364days from the date of issue.The Company uses net proceeds from its Commercial Paper Program and the Receivables Facility as a source of liquidity for general corporatepurposes, including for business development transactions, working capital and share repurchases. Commercial paper borrowings and the ReceivablesFacility may vary during a particular period, as a result of fluctuations in working capital requirements and timing of cash receipts.110Table of ContentsLong-Term DebtA summary of long-term debt is as follows:(In millions)Coupon December 31, 2018 December 31, 2017Current portion of long-term debt: 2016 Term Facility (a) **3.897% $100.0 $—2018 Senior Notes *2.600% — 649.92018 Floating Rate Euro Notes (b) ** — 600.22018 Senior Notes **3.000% — 499.82019 Senior Notes **2.500% 549.9 —Other 6.2 2.4Deferred financing fees (0.9) (3.1)Current portion of long-term debt $655.2 $1,749.2 Non-current portion of long-term debt: 2016 Term Facility (a) **3.897% $— $100.02019 Senior Notes **2.500% — 999.52019 Senior Notes *2.550% — 499.72020 Floating Rate Euro Notes (c) ** 573.3 600.22020 Euro Senior Notes **1.250% 858.1 897.62020 Senior Notes **3.750% 499.9 499.92021 Senior Notes **3.150% 2,248.7 2,248.22023 Senior Notes *3.125% 752.9 765.42023 Senior Notes *4.200% 498.9 498.82024 Euro Senior Notes **2.250% 1,144.2 1,197.72025 Euro Senior Notes *2.125% 572.0 —2026 Senior Notes **3.950% 2,236.5 2,235.02028 Euro Senior Notes **3.125% 852.5 892.02028 Senior Notes *4.550% 748.2 —2043 Senior Notes *5.400% 497.2 497.12046 Senior Notes **5.250% 999.8 999.82048 Senior Notes *5.200% 747.6 —Other 5.1 6.3Deferred financing fees (73.7) (71.9)Long-term debt $13,161.2 $12,865.3____________(a) The 2016 Term Facility bears interest at LIBOR plus a base rate, which margins can fluctuate based on the Company’s credit ratings.(b) Interest rate of the instrument was three-month EURIBOR plus 0.870% per annum, reset quarterly.(c) Instrument bears interest at a rate of three-month EURIBOR plus 0.50% per annum, reset quarterly.*Instrument was issued by Mylan Inc.** Instrument was issued by Mylan N.V.2016 Revolving Facility, 2018 Revolving Facility and 2016 Term FacilityOn November 22, 2016, the Company entered into a revolving credit facility among the Company, as borrower, Mylan Inc., as a guarantor, certainlenders and issuing banks and Bank of America, N.A., as the administrative agent, pursuant to which the Company may obtain extensions of credit in anaggregate principal amount not to exceed $2.0 billion (the “2016111Table of ContentsRevolving Facility”). On the same day, the Company entered into a term credit facility among the Company, as borrower, Mylan Inc., as a guarantor, certainlenders and Goldman Sachs Bank USA, as administrative agent, pursuant to which the Company has $100.0 million outstanding in term loans (the “2016Term Facility”) at December 31, 2018. On July 27, 2018, the Company entered into a revolving credit facility among Mylan Inc., as borrower, the Company,as a guarantor, certain lenders and issuing banks and Bank of America, N.A., as the administrative agent, which replaced the 2016 Revolving Facility onsubstantially identical terms to the 2016 Revolving Facility and pursuant to which Mylan Inc. may obtain extensions of credit in an aggregate principalamount not to exceed $2.0 billion (the “2018 Revolving Facility”).The 2016 Term Facility and the 2018 Revolving Facility each contain customary affirmative covenants for facilities of this type, including amongothers, covenants pertaining to the delivery of financial statements, notices of default and certain material events, maintenance of corporate existence andrights, property, and insurance and compliance with laws, as well as customary negative covenants for facilities of this type, including limitations on theincurrence of subsidiary indebtedness, liens, mergers and certain other fundamental changes, investments and loans, acquisitions, transactions with affiliates,payments of dividends and other restricted payments and changes in our lines of business.The 2016 Term Facility and 2018 Revolving Facility contain a maximum consolidated leverage ratio financial covenant requiring maintenance of amaximum ratio of 3.75 to 1.00 for consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters asdefined in the related credit agreements (“leverage ratio”).The 2016 Term Facility was amended in November 2017 to allow a leverage ratio of 4.25 to 1.00 through the December 31, 2018 reporting periodand a leverage ratio of 3.75 to 1.00 thereafter. The 2018 Revolving Facility similarly provides for a leverage ratio of 4.25 to 1.00 through the December 31,2018 reporting period and a leverage ratio of 3.75 to 1.00 thereafter. On February 22, 2019, the Company, as a guarantor, and Mylan Inc., as borrower, enteredinto an amendment (the "Revolving Loan Amendment") to the 2018 Revolving Facility. In addition, on February 22, 2019, the Company entered into anamendment (the "Term Loan Amendment") to the 2016 Term Facility. The Revolving Loan Amendment and the Term Loan Amendment extended theleverage ratio covenant of 4.25 to 1.00 through the December 31, 2019 reporting period, with a leverage ratio of 3.75 to 1.00 thereafter. The Company is incompliance at December 31, 2018 and expects to remain in compliance for the next twelve months.Senior NotesIssuance of 2018 Senior NotesThe following table provides the amounts of senior unsecured debt issued by Mylan Inc. and guaranteed by Mylan N.V., on April 9, 2018 (the “April2018 Senior Notes”). The April 2018 Senior Notes were issued pursuant to an indenture dated April 9, 2018. The April 2018 Senior Notes were issued in aprivate offering exempt from the registration requirements of the Securities Act to qualified institutional buyers in accordance with Rule 144A under theSecurities Act and to persons outside of the U.S. pursuant to Regulation S under the Securities Act. The Company has entered into a registration rightsagreement, dated as of April 9, 2018 pursuant to which Mylan Inc. and Mylan N.V. are required to use commercially reasonable efforts to file a registrationstatement with respect to an offer to exchange each series of the April 2018 Senior Notes for new notes with the same aggregate principal amount and termssubstantially identical in all material respects.(In millions)Interest Rate PrincipalAmount2028 Senior Notes (1)4.550% $750.02048 Senior Notes (1)5.200% 750.0Total April 2018 Senior Notes $1,500.0____________(1) Redeemable, in whole or in part, at our option at any time prior to three months (in the case of the 2028 Senior Notes) or six months (in the case ofthe 2048 Senior Notes) of the maturity date at the greater of 100% of the principal amount or the sum of the present values of the remainingscheduled payments of principal and interest discounted at the U.S. Treasury rate plus an incremental spread of 0.30% (in the case of the 2028 SeniorNotes) or 0.35% (in the case of the 2048 Senior Notes), plus, in each case, accrued and unpaid interest.On April 28, 2018, the Company redeemed all of the outstanding $650 million principal amount of Mylan Inc.’s 2.600% senior notes due 2018, allof the outstanding $500 million principal amount of Mylan N.V.’s 3.000% senior notes due112Table of Contents2018 and $350 million of the outstanding $500 million principal amount of Mylan Inc.’s 2.550% senior notes due 2019. The redemption of these notes wasfunded with the net proceeds from the April 2018 Senior Notes offering.In November 2018, Mylan N.V. and Mylan Inc. filed a registration statement with the Securities and Exchange Commission (“SEC”) with respect toan offer to exchange these notes for registered notes with the same aggregate principal amount and terms substantially identical in all material respects, whichwas declared effective on December 11, 2018. The exchange offer expired on January 9, 2019 and settled on January 10, 2019. 100% of each of the 4.550%Senior Notes due 2028 and the 5.200% Senior Notes due 2048 were exchanged. Issuance of 2018 Euro Senior NotesOn May 23, 2018, Mylan Inc. completed the offering of €500 million aggregate principal amount of its 2.125% Euro Senior Notes due 2025 (the“May 2018 Euro Senior Notes”). The May 2018 Euro Senior Notes were issued pursuant to an indenture dated May 23, 2018. The May 2018 Euro SeniorNotes are guaranteed by Mylan N.V. and were issued in a private offering exempt from the registration requirements of the Securities Act, to persons outsideof the U.S. pursuant to Regulation S under the Securities Act. The May 2018 Euro Senior Notes are redeemable, in whole or in part, at our option at any timeprior to three months of the maturity date at the greater of 100% of the principal amount or the sum of the present values of the remaining scheduledpayments of principal and interest discounted at the applicable Bund Rate plus an incremental spread of 0.30%, plus, in each case, accrued and unpaidinterest.On June 15, 2018, the Company redeemed the remaining $150 million outstanding principal amount of Mylan Inc.’s 2.550% Senior Notes due 2019and $450 million of the outstanding $1.0 billion principal amount of Mylan N.V.’s 2.500% Senior Notes due 2019. The redemption of these notes wasfunded with the net proceeds from the May 2018 Euro Senior Notes offering.Issuance of 2017 Euro Senior NotesOn May 24, 2017, the Company completed its offering of €500 million aggregate principal amount of Floating Rate Senior Notes due 2020 (the“May 2017 Floating Rate Euro Senior Notes”), issued pursuant to the indenture dated May 24, 2017 (the “2017 Euro Notes Indenture”). The May 2017Floating Rate Euro Senior Notes will mature on May 24, 2020 and cannot be redeemed prior to maturity at the option of the Company.The May 2017 Floating Rate Euro Senior Notes were issued in a private offering exempt from the registration requirements of the Securities Act topersons outside of the U.S. pursuant to Regulation S under the Securities Act. The May 2017 Floating Rate Euro Senior Notes are the Company’s seniorunsecured indebtedness and are guaranteed on a senior unsecured basis by Mylan Inc.The May 2017 Floating Rate Euro Senior Notes bear interest at a rate per annum, reset quarterly, equal to the sum of (i) three-month EURIBOR (asdefined in the 2017 Euro Notes Indenture) plus (ii) 0.50%, provided, however, that the minimum interest rate is zero. Interest on the May 2017 Floating RateEuro Senior Notes is payable quarterly in arrears on each February 24, May 24, August 24 and November 24. The interest rate at December 31, 2018 wasapproximately 0.17% per annum.The Company utilized the net proceeds from the May 2017 Floating Rate Euro Senior Notes offering to repay a portion of the term loans under the2016 Term Facility and to pay associated fees and expenses.Fair ValueAt December 31, 2018 and 2017, the aggregate fair value of the Company’s outstanding notes was approximately $13.10 billion and $14.93 billion,respectively. The fair values of the outstanding notes were valued at quoted market prices from broker or dealer quotations and were classified as Level 2 inthe fair value hierarchy. Based on quoted market rates of interest and maturity schedules of similar debt issues, the fair value of the Company’s 2016 TermFacility determined based on Level 2 inputs, approximates its carrying value at December 31, 2018 and 2017.113Table of ContentsMandatory minimum repayments remaining on the outstanding long-term debt at December 31, 2018, excluding the discounts and premiums, are asfollows for each of the periods ending December 31:(In millions)Total2019$65020201,93320212,2502022—20231,250Thereafter7,830Total$13,91310.Comprehensive EarningsAccumulated other comprehensive loss, as reflected on the Consolidated Balance Sheets, is comprised of the following:(In millions)December 31,2018 December 31, 2017Accumulated other comprehensive loss: Net unrealized gain on marketable securities, net of tax$— $10.1Net unrecognized gains and prior service cost related to defined benefit plans, net of tax1.7 6.0Net unrecognized losses on derivatives in cash flow hedging relationships, net of tax(53.1) (3.7)Net unrecognized losses on derivatives in net investment hedging relationships, net of tax(130.9) (239.8)Foreign currency translation adjustment(1,259.0) (133.8) $(1,441.3) $(361.2)114Table of ContentsComponents of accumulated other comprehensive (loss) earnings, before tax, consist of the following: Year Ended December 31, 2018Gains and Losses on Derivatives in CashFlow Hedging Relationships Gains andLosses on NetInvestmentHedges Gains andLosses onMarketableSecurities DefinedPensionPlan Items ForeignCurrencyTranslationAdjustment Totals(In millions)ForeignCurrencyForwardContracts InterestRateSwaps Total Balance at December 31, 2017, net of tax $(3.7) $(239.8) $10.1 $6.0 $(133.8) $(361.2)Other comprehensive (loss) earningsbefore reclassifications, before tax (80.7) 111.6 (0.1) (3.0) (1,125.2) (1,097.4)Amounts reclassified from accumulatedother comprehensive (loss) earnings,before tax: Gain on foreign exchange forwardcontracts classified as cash flowhedges, included in net sales(6.2) (6.2) (6.2)Loss on interest rate swaps classifiedas cash flow hedges, included ininterest expense 7.7 7.7 7.7Amortization of prior service costsincluded in SG&A (0.4) (0.4)Amortization of actuarial lossincluded in SG&A (0.4) (0.4)Net other comprehensive (loss)earnings, before tax (79.2) 111.6 (0.1) (3.8) (1,125.2) (1,096.7)Income tax (benefit) provision (27.3) 2.7 — 0.5 — (24.1)Cumulative effect of the adoption ofnew accounting standards $2.5 $— $(10.0) $— $— $(7.5)Balance at December 31, 2018, net of tax $(53.1) $(130.9) $— $1.7 $(1,259.0) $(1,441.3)115Table of Contents Year Ended December 31, 2017Gains and Losses on Derivatives in CashFlow Hedging Relationships Gains andLosses on NetInvestmentHedges Gains andLosses onMarketableSecurities DefinedPensionPlan Items ForeignCurrencyTranslationAdjustment Totals(In millions)ForeignCurrencyForwardContracts InterestRateSwaps Total Balance at December 31, 2016, net of tax $(38.6) $(1.4) $14.5 $(0.5) $(2,237.7) $(2,263.7)Other comprehensive (loss) earningsbefore reclassifications, before tax 46.5 (238.4) (6.7) 2.9 2,103.9 1,908.2Amounts reclassified fromaccumulated other comprehensive(loss) earnings, before tax: Loss on foreign exchange forwardcontracts classified as cash flowhedges, included in net sales(1.1) (1.1) (1.1)Loss on interest rate swapsclassified as cash flow hedges,included in interest expense 7.3 7.3 7.3Amortization of prior service costsincluded in SG&A 0.2 0.2Amortization of actuarial gainincluded in SG&A 0.7 0.7Net other comprehensive (loss)earnings, before tax 52.7 (238.4) (6.7) 3.8 2,103.9 1,915.3Income tax (benefit) provision 17.8 — (2.3) (2.7) — 12.8Balance at December 31, 2017, net of tax $(3.7) $(239.8) $10.1 $6.0 $(133.8) $(361.2)116Table of Contents Year Ended December 31, 2016 Gains and Losses on Derivatives inCash Flow Hedging Relationships Gains andLosses on NetInvestmentHedges Gains andLosses onMarketableSecurities DefinedPensionPlan Items ForeignCurrencyTranslationAdjustment Totals(In millions)ForeignCurrencyForwardContracts InterestRate Swaps Total Balance at December 31, 2015, net of tax $(18.1) $— $(1.0) $(14.9) $(1,730.3) $(1,764.3)Other comprehensive earnings (loss)before reclassifications, before tax (84.2) (1.8) 24.6 20.0 (507.4) (548.8)Amounts reclassified fromaccumulated other comprehensiveloss, before tax: Loss on foreign exchange forwardcontracts classified as cash flowhedges, included in net sales(44.3) 44.3 44.3Loss on interest rate swapsclassified as cash flow hedges,included in interest expense (8.7) 8.7 8.7Amortization of prior service costsincluded in SG&A 0.3 0.3Amortization of actuarial gainincluded in SG&A 1.1 1.1Net other comprehensive loss, beforetax (31.2) (1.8) 24.6 21.4 (507.4) (494.4)Income tax provision (benefit) (10.7) (0.4) 9.1 7.0 — 5.0Balance at December 31, 2016, net of tax $(38.6) $(1.4) $14.5 $(0.5) $(2,237.7) $(2,263.7)11.Income TaxesOn December 22, 2017, the U.S. government enacted the Tax Act. The Tax Act makes broad and complex changes to the Code including, but notlimited to, reducing the U.S. federal corporate income tax rate and requiring a one-time transition tax on certain unrepatriated earnings of non-U.S. corporatesubsidiaries of large U.S. shareholders that may electively be paid over eight years. While the Tax Act reduces the U.S. federal corporate income tax rate from35% to 21% for tax years beginning after December 31, 2017, ASC Topic 740 required the Company to remeasure its deferred tax balances at December 31,2017 in accordance with the 2018 rate reduction.The Tax Act also puts in place new tax laws that impact our taxable income beginning in 2018, which include, but are not limited to (1) creating aBase Erosion Anti-Abuse Tax (“BEAT”), which is a new minimum tax, (2) generally eliminating U.S. federal income taxes on dividends from foreignsubsidiaries, (3) a new provision designed to tax currently global intangible low-taxed income (“GILTI”) earned by non-U.S. corporate subsidiaries of largeU.S. shareholders and a deduction generally equal to 50 percent of GILTI (37.5 percent for tax years beginning after December 31, 2025) to offset the incometax liability, (4) a provision limiting the amount of deductible interest expense in the U.S., (5) the repeal of the domestic manufacturing deduction, (6)limitations on the deductibility of certain executive compensation, and (7) limitations on the utilization of foreign tax credits to reduce the U.S. income taxliability.Shortly after the Tax Act was enacted, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cutsand Jobs Act (“SAB 118”) which provided guidance on accounting for the Tax Act’s impact. SAB 118 provides a measurement period, which in no caseshould extend beyond one year from the Tax Act enactment date, during which a company acting in good faith may complete the accounting for the impactsof the Tax Act under ASC Topic 740.117Table of ContentsTo the extent that the accounting for certain income tax effects of the Tax Act is incomplete, a company can determine a reasonable estimate forthose effects and record a provisional estimate in the financial statements in the first reporting period in which a reasonable estimate can be determined. TheCompany recorded a provisional net tax charge of $128.6 million related to the Tax Act in the year ended December 31, 2017. This net charge primarilyconsisted of a net expense of $15.0 million due to the remeasurement of our net deferred tax accounts to reflect the U.S. federal corporate income tax ratereduction to 21% and a net expense for the transition tax of $113.6 million.The transition tax is a 2017 tax on the previously untaxed accumulated and current earnings and profits of certain of our foreign subsidiaries, whichthe Company expects to pay, net of certain tax attributes and credit carryforwards, over eight years beginning in 2018.Proposed regulations issued by the U.S. Department of the Treasury on August 1, 2018, provided further interpretive guidance on the transition tax.During the year ended December 31, 2018, the Company revised its estimated liability for the transition tax from $113.6 million to $99.1 million. The $14.5million benefit was recorded as a component of the Company’s tax provision during the year ended December 31, 2018.The Tax Act includes a provision designed to currently tax GILTI earned by non-U.S. corporate subsidiaries of large U.S. shareholders starting in2018. The Company has elected, as permitted in FASB Staff Q&A - Topic 740 - No. 5, to treat any future GILTI tax liabilities as period costs and will expensethose liabilities in the period incurred. The Company has not recorded deferred taxes associated with the GILTI provision of the Tax Act.As of December 31, 2018, the Company’s practice and intention was to reinvest the earnings in our non-U.S. subsidiaries outside of the U.S., and noU.S. deferred income taxes or foreign withholding taxes were recorded. The transition tax noted above resulted in the previously untaxed foreign earnings ofU.S. subsidiaries being included in the federal and state taxable income. We analyze on an ongoing basis our global working capital requirements and thepotential tax liabilities that would be incurred if the non-U.S. subsidiaries repatriate cash, which include potential local country withholding taxes and U.S.state taxation.The Company’s accounting for the impact of the 2017 Tax Act was completed during the year ended December 31, 2018. However, the Companycontinues to analyze the provisions of the Tax Act. Subsequent to the enactment of the Tax Act, additional guidance was issued by the U.S. Department ofthe Treasury, including Notices, Proposed Regulations, and Final Regulations. Further guidance may be issued in 2019 which could impact ourinterpretations of the Tax Act and materially impact the amounts recorded related to the Tax Act.118Table of ContentsThe income tax provision (benefit) consisted of the following components: Year Ended December 31,(In millions)2018 2017 2016U.S. Federal: Current$(68.2) $39.5 $86.8Deferred(112.9) 28.2 (303.8) (181.1) 67.7 (217.0)U.S. State: Current6.8 3.9 13.8Deferred(12.3) (0.6) (14.8) (5.5) 3.3 (1.0)Non-U.S.: Current271.6 275.0 150.6Deferred(139.1) (139.0) (290.9) 132.5 136.0 (140.3)Income tax (benefit) provision$(54.1) $207.0 $(358.3)Earnings before income taxes: United Kingdom$1,259.8 $89.7 $(129.4)United States(1,000.5) (414.5) (187.4)Foreign - Other39.1 1,227.8 438.5Total earnings before income taxes$298.4 $903.0 $121.7For all periods presented, the allocation of earnings before income taxes between U.S. and non-U.S. operations includes intercompany interestallocations between certain domestic and foreign subsidiaries. These amounts are eliminated on a consolidated basis.Temporary differences and carry-forwards that result in deferred tax assets and liabilities were as follows:(In millions)December 31, 2018 December 31, 2017Deferred tax assets: Employee benefits$184.8 $215.0Litigation reserves15.7 45.3Accounts receivable allowances217.7 251.7Tax credit and loss carry-forwards891.4 849.9Interest expense373.5 151.7Intangible assets104.1 114.9Other182.4 212.4 1,969.6 1,840.9Less: Valuation allowance(806.0) (662.8)Total deferred tax assets1,163.6 1,178.1Deferred tax liabilities: Plant and equipment105.6 120.7Intangible assets and goodwill2,189.2 2,538.2Other18.7 34.8Total deferred tax liabilities2,313.5 2,693.7Deferred tax liabilities, net$(1,149.9) $(1,515.6)119Table of ContentsFor those foreign subsidiaries whose investments are permanent in duration, income and foreign withholding taxes have not been provided on theamount by which the investment in those subsidiaries, as recorded for U.S. GAAP purposes, exceeds the tax basis. This amount may become taxable upon arepatriation of assets from the subsidiary or a sale or liquidation of the subsidiary. The amount of such temporary differences is approximately $1.8 billion atDecember 31, 2018. Determination of the amount of any unrecognized deferred income tax liability on this temporary difference is not practicable as suchdetermination involves material uncertainties about the potential extent and timing of any distributions, the availability and complexity of calculatingforeign tax credits, and the potential indirect tax consequences of such distributions, including withholding taxes. No deferred taxes have been recorded onthe instances whereby the Company’s investment in foreign subsidiaries is currently greater for tax purposes than for U.S. GAAP purposes, as managementhas no current plans that would cause that temporary difference to reverse in the foreseeable future.A reconciliation of the UK statutory tax rate of 19% to the effective tax rate is as follows: Year Ended December 31, 2018 2017 2016Statutory tax rate19.0 % 19.0 % 20.0 % United States Operations Clean energy and research credits(33.1)% (10.1)% (85.9)%U.S. rate differential(5.4)% 7.4 % (36.9)%Tax Act - transition tax & deferred tax rate change(4.9)% 8.4 % — %Uncertain tax positions(22.5)% 1.0 % 2.2 %State income taxes and credits(3.2)% (0.6)% (8.1)% Valuation allowance54.2 % 10.3 % 4.4 %Global intangible low-taxed income8.6 % — % — %Other U.S. items7.5 % 0.2 % 1.3 %Other Foreign Operations Luxembourg(28.3)% (10.1)% (52.6)%Luxembourg — U.S. Branch— % — % (28.8)%Gibraltar(19.2)% (6.5)% (49.2)%India(0.6)% (0.5)% (13.0)%Ireland(3.5)% (1.4)% (7.2)%Other9.0 % 2.7 % 2.0 %Deferred tax rate change(5.2)% (2.6)% (5.2)%Valuation allowance(4.3)% 3.9 % 79.9 %Withholding taxes4.1 % 1.3 % 14.3 %Merger of foreign subsidiaries— % — % (123.5)%Other foreign items9.7 % 0.5 % (8.1)%Effective tax rate(18.1)% 22.9 % (294.4)%During 2016, the Company merged its wholly owned subsidiary, Jai Pharma Limited, into Mylan India. The merger resulted in the recognition of adeferred tax asset of approximately $150 million for the tax deductible goodwill in excess of the book goodwill with a corresponding benefit to income taxprovision for the year ended December 31, 2016.Valuation AllowanceA valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized. AtDecember 31, 2018, a valuation allowance has been applied to certain deferred tax assets in the amount of $806.0 million.When assessing the realizability of deferred tax assets, management considers all available evidence, including historical information, long-termforecasts of future taxable income and possible tax planning strategies. Amounts recorded for120Table of Contentsvaluation allowances can result from a complex series of estimates, assumptions and judgments about future events. Due to the inherent uncertainty involvedin making these estimates, assumptions and judgments, actual results could differ materially. Any future increases to the Company’s valuation allowancescould materially impact the Company’s consolidated financial condition and results of operations.Net Operating LossesAs of December 31, 2018, the Company has U.S. federal net operating loss carry-forwards of $44.0 million, and U.S. state income tax loss carry-forwards of approximately $2.80 billion. The Company also has non-U.S. net operating loss carryforwards of approximately $1.69 billion, of which $1.39billion can be carried forward indefinitely, with the remaining $300.0 million expiring in years 2019 through 2037. Most of the net operating losses have afull valuation allowance. The Company also has $71.0 million of foreign deductible attributes that can be carried forward indefinitely.The Company has $73.4 million of foreign capital loss carry-forwards expiring in 2019 through 2022. A full valuation allowance is recorded againstthese losses. The Company also has $211.0 million of U.S. and foreign credit carryovers, expiring in various amounts through 2038.Tax ExaminationsThe Company is subject to income taxes and tax audits in many jurisdictions. A certain degree of estimation is thus required in recording the assetsand liabilities related to income taxes. Tax audits and examinations can involve complex issues, interpretations, and judgments and the resolution of mattersthat may span multiple years, particularly if subject to litigation or negotiation.Although the Company believes that adequate provisions have been made for these uncertain tax positions, the Company’s assessment of uncertaintax positions is based on estimates and assumptions that the Company believes are reasonable but the estimates for unrecognized tax benefits and potentialtax benefits may not be representative of actual outcomes, and variations from such estimates could materially affect the Company’s financial condition,results of operations or cash flows in the period of resolution, settlement or when the statutes of limitations expire.Mylan is subject to ongoing U.S. Internal Revenue Service (“IRS”) examinations and is a voluntary participant in the IRS Compliance AssuranceProcess (“CAP”), which allows Mylan to work collaboratively with the IRS to identify and review tax matters on an ongoing basis. The years 2015, 2016 and2017 are open years under examination. The years 2012, 2013 and 2014 have one matter open, and a Tax Court petition has been filed regarding the matterand a trial was held in December 2018. On February 27, 2015, Mylan N.V. acquired Mylan Inc. and Abbott Laboratories’ non-U.S. developed marketsspecialty and branded generics business (collectively, the “EPD Business Acquisition”). In connection with the EPD Business Acquisition, we entered intointercompany transactions with our affiliates that affect our U.S. tax liability. Mylan N.V. is not incorporated in the U.S. and expects to be treated as a non-U.S. corporation for U.S. federal income tax purposes. As part of our ongoing participation and cooperation in the CAP, we have received and responded tovarious IRS requests for information about, among other matters, the EPD Business Acquisition, including the interest rates used for intercompany loans andour status as a non-U.S. corporation for U.S. federal income tax purposes. As previously disclosed, the IRS may challenge our positions on the EPD BusinessAcquisition. We remain confident in our positions and, should the IRS choose to challenge our positions, we would vigorously defend our positions throughall available channels. If the IRS chooses to challenge our positions, and if the IRS succeeds, we would be subject to significantly greater U.S. tax liability,beginning February 27, 2015, than currently contemplated as a non-U.S. corporation, which would have a material adverse effect on our business, financialcondition, results of operations, cash flows, and/or ordinary share price.The Company’s major state taxing jurisdictions remain open from fiscal year 2008 through 2017, with several state audits currently in progress. TheCompany’s major international taxing jurisdictions remain open from 2011 through 2017, some of which are indemnified by Strides Arcolab for taxassessments.121Table of ContentsTax Court Proceeding The Company's U.S. federal income tax returns for 2007 through 2011 had been subject to proceedings in U.S. Tax Court involving a dispute withthe IRS regarding whether the proceeds received by the Company in connection with the 2008 sale of its rights in nebivolol constituted a capital gain orordinary income. The Company and the IRS filed a joint stipulation of settled issues with the Tax Court that resolved all issues in this dispute and the TaxCourt issued the final order closing the case during 2018.Accounting for Uncertainty in Income TaxesThe impact of an uncertain tax position that is more likely than not of being sustained upon audit by the relevant taxing authority must berecognized at the largest amount that is more likely than not to be sustained. No portion of an uncertain tax position will be recognized if the position hasless than a 50% likelihood of being sustained.As of December 31, 2018 and 2017, the Company’s Consolidated Balance Sheets reflect net liabilities for unrecognized tax benefits of $96.3million and $185.7 million, of which $96.3 million and $138.4 million, respectively, would affect the Company’s effective tax rate if recognized. Accruedinterest and penalties included in the Consolidated Balance Sheets were $72.6 million and $90.9 million as of December 31, 2018 and 2017, respectively.For the year ended December 31, 2018, 2017 and 2016, Mylan recognized $18.3 million of interest income and $11.1 million and $6.9 million, respectively,of interest expense related to uncertain tax positions. Interest and penalties related to income taxes are included in the tax provision.A reconciliation of the unrecognized tax benefits is as follows: Year Ended December 31,(In millions)2018 2017 2016Unrecognized tax benefit — beginning of year$185.7 $190.9 $174.1Additions for current year tax positions— 4.4 2.1Additions for prior year tax positions20.0 5.5 —Reductions for prior year tax positions(5.8) (0.8) (1.8)Settlements(32.9) (0.4) —Reductions due to expirations of statute of limitations(70.7) (13.9) (7.7)Addition due to acquisition— — 24.2Unrecognized tax benefit — end of year$96.3 $185.7 $190.9The Company believes that it is reasonably possible that the amount of unrecognized tax benefits will decrease in the next twelve months byapproximately $40.0 million, involving federal and state audits and settlements and expirations of certain state, federal, and foreign statutes of limitations.The Company does not anticipate significant increases to the reserve within the next twelve months.12.Share-Based Incentive PlanThe Company’s shareholders have approved the 2003 Long-Term Incentive Plan (as amended, the “2003 Plan”). Under the 2003 Plan,55,300,000 ordinary shares are reserved for issuance to key employees, consultants, independent contractors and non-employee directors of the Companythrough a variety of incentive awards, including: stock options, stock appreciation rights (“SAR”), restricted ordinary shares and units, performance awards(“PSU”), other stock-based awards and short-term cash awards. Stock option awards are granted with an exercise price equal to the fair market value of theordinary shares underlying the options at the date of the grant, generally become exercisable over periods ranging from three to four years, and generallyexpire in ten years.122Table of ContentsThe following table summarizes stock option and SAR (together, “stock awards”) activity: Number of SharesUnder Stock Awards WeightedAverageExercise Priceper ShareOutstanding at December 31, 20157,732,499 $31.85Granted876,397 45.51Exercised(612,477) 23.13Forfeited(296,978) 50.70Outstanding at December 31, 20167,699,441 $33.38Granted964,475 42.48Exercised(902,041) 20.06Forfeited(563,191) 47.36Outstanding at December 31, 20177,198,684 $35.17Granted905,265 40.38Exercised(820,603) 21.75Forfeited(468,068) 47.86Outstanding at December 31, 20186,815,278 $36.61Vested and expected to vest at December 31, 20186,603,247 $36.41Exercisable at December 31, 20185,134,445 $34.76As of December 31, 2018, stock awards outstanding, stock awards vested and expected to vest, and stock awards exercisable had average remainingcontractual terms of 5.3 years, 5.2 years and 4.2 years, respectively. Also at December 31, 2018, stock awards outstanding, stock awards vested and expectedto vest and stock awards exercisable each had aggregate intrinsic values of $15.9 million.A summary of the status of the Company’s nonvested restricted ordinary shares and restricted stock unit awards, including PSUs (collectively,“restricted stock awards”) as of December 31, 2017 and the changes during the year ended December 31, 2018 are presented below: Number of RestrictedStock Awards Weighted AverageGrant-DateFair Value Per ShareNonvested at December 31, 20175,964,207 $41.92Granted1,542,727 41.00Released(762,561) 49.11Forfeited(351,292) 43.70Nonvested at December 31, 20186,393,081 $40.75Of the 1,542,727 restricted stock awards granted during the year ended December 31, 2018, 757,433 vest ratably in three years or less and are notsubject to market or performance conditions. Of the remaining restricted stock awards granted, 668,878 are subject to market conditions and will cliff vest inthree years or less and 116,416 are not subject to market or performance conditions and will cliff vest in one year or less.As of December 31, 2018, the Company had $80.6 million of total unrecognized compensation expense, net of estimated forfeitures, related to all ofits stock-based awards, which we expect to be recognized over the remaining weighted average vesting period of 1.5 years. The total intrinsic value of stock-based awards exercised and restricted stock awards released during the years ended December 31, 2018 and 2017 was $46.3 million and $39.1 million,respectively.123Table of ContentsWith respect to options granted under the Company’s 2003 Plan, the fair value of each option grant was estimated at the date of grant using theBlack-Scholes option pricing model. Black-Scholes utilizes assumptions related to volatility, the risk-free interest rate, the dividend yield and employeeexercise behavior. Expected volatilities utilized in the model are based mainly on the implied volatility of the Company’s stock price and other factors. Therisk-free interest rate is derived from the U.S. Treasury yield curve in effect at the time of grant. The model incorporates exercise and post-vesting forfeitureassumptions based on an analysis of historical data. The expected lives of the grants are derived from historical and other factors.The assumptions used for options granted under the 2003 Plan are as follows: Year Ended December 31, 2018 2017 2016Volatility35.8% 33.2% 38.1%Risk-free interest rate2.8% 2.2% 1.4%Expected term (years)6.5 6.4 6.3Forfeiture rate5.5% 5.5% 5.5%Weighted average grant date fair value per option$16.51 $15.88 $17.90In February 2014, Mylan’s Compensation Committee and the independent members of the Board of Directors adopted the One-Time SpecialPerformance-Based Five-Year Realizable Value Incentive Program (the “2014 Program”) under the 2003 Plan. Under the 2014 Program, certain keyemployees received a one-time, performance-based incentive award (the “Awards”) either in the form of a grant of SARs or PSUs. The initial Awards weregranted in February 2014 and contain a five-year cliff-vesting feature based on the achievement of various performance targets, external market conditionsand the employee’s continued services. Additional Awards were granted in 2016 and 2017 and are subject to the same performance conditions as the Awardsgranted in February 2014 and with a service vesting condition of between two and six years. The market condition was met on June 10, 2015. During the yearended December 31, 2018, the Company determined that it was no longer probable that the minimum performance condition would be met and thereforereversed all of the cumulative expense related to the Awards resulting in a reduction in share-based compensation expense of approximately $70.6 million. Inaddition, during the year ended December 31, 2018, the Company recorded $20.0 million of compensation expense as an additional discretionary bonus for acertain group of employees. None of the employees who are eligible for this bonus are named executive officers. As of December 31, 2018, there areapproximately 2.6 million Awards outstanding under the 2014 Program, which are expected to be canceled in the first quarter of 2019.13.Employee Benefit PlansDefined Benefit PlansThe Company sponsors various defined benefit pension plans in several countries. Benefits provided generally depend on length of service, paygrade and remuneration levels. The Company maintains two fully frozen defined benefit pension plans in the U.S., and employees in the U.S. and Puerto Ricoare provided retirement benefits through defined contribution plans rather than through a defined benefit plan.The Company also sponsors other postretirement benefit plans. There are plans that provide for postretirement supplemental medical coverage.Benefits from these plans are paid to certain employees and their spouses and dependents who meet various minimum age and service requirements. Inaddition, there are plans that provide for life insurance benefits and postretirement medical coverage for certain officers and management employees.Accounting for Defined Benefit Pension and Other Postretirement PlansThe Company recognizes on its balance sheet an asset or liability equal to the over- or under-funded benefit obligation of each defined benefitpension and other postretirement plan. Actuarial gains or losses and prior service costs or credits that arise during the period are not recognized ascomponents of net periodic benefit cost, but are recognized, net of tax, as a component of other comprehensive income.Included in accumulated other comprehensive loss as of December 31, 2018 and 2017 are:124Table of Contents Pension Benefits Other Postretirement Benefits December 31, December 31,(In millions)2018 2017 2018 2017Unrecognized actuarial (gains) losses$(10.3) $(8.6) $1.1 $2.0Unrecognized prior service costs12.1 2.0 0.7 0.7Total$1.8 $(6.6) $1.8 $2.7Of the December 31, 2018 amount, the Company expects to recognize approximately $0.9 million of unrecognized actuarial gains and $1.0 millionof unrecognized prior service costs in net periodic benefit cost during 2019. The unrecognized net actuarial losses exceeded 10% of the higher of the marketvalue of plan assets or the projected benefit obligation at the beginning of the year for certain of the plans, therefore, amortization of such excess has beenincluded in net periodic benefit costs for pension and other postretirement benefits in each of the last three years. The amortization period is the averageremaining service period that active employees are expected to receive benefits, unless a plan is mostly inactive in which case the amortization period is theaverage remaining life expectancy of the plan participants. Unrecognized prior service cost is amortized over the future service periods of those employeeswho are active at the dates of the plan amendments and who are expected to receive benefits. If all or almost all of a plan's participants are inactive,unrecognized prior service cost is amortized over the remaining life expectancy of those participants. The increase in accumulated other comprehensiveincome in 2018 relating to pension benefits and other postretirement benefits consists of:(In millions)Pension Benefits Other PostretirementBenefitsUnrecognized actuarial (gain)/loss$(2.1) $(0.6)Amortization of actuarial (gain)/loss(0.1) (0.3)Unrecognized prior service costs6.6 —Amortization of prior service costs(0.4) —Impact of foreign currency translation0.7 —Net change$4.7 $(0.9)Components of net periodic benefit cost, change in projected benefit obligation, change in plan assets, funded status, fair value of plan assets,assumptions used to determine net periodic benefit cost, funding policy and estimated future benefit payments are summarized below for the Company’spension plans and other postretirement plans.Net Periodic Benefit CostComponents of net periodic benefit cost for the years ended December 31, 2018, 2017 and 2016 were as follows: Pension Benefits Other Postretirement Benefits December 31, December 31,(In millions)2018 2017 2016 2018 2017 2016Service cost$19.2 $20.1 $17.4 $0.6 $0.7 $0.6Interest cost13.0 13.6 8.2 1.5 1.6 1.3Expected return on plan assets(14.4) (14.3) (10.9) — — —Plan curtailment, settlement and termination(0.1) (1.7) (2.4) — — —Amortization of prior service costs0.3 0.2 0.3 — — —Recognized net actuarial (gains) losses(0.1) 0.3 0.8 0.2 0.4 0.3Net periodic benefit cost$17.9 $18.2 $13.4 $2.3 $2.7 $2.2125Table of ContentsChange in Projected Benefit Obligation, Change in Plan Assets and Funded StatusThe table below presents components of the change in projected benefit obligation, change in plan assets and funded status at December 31, 2018and 2017. Pension Benefits Other Postretirement Benefits(In millions)2018 2017 2018 2017Change in Projected Benefit Obligation Projected benefit obligation, beginning of year$665.2 $632.9 $35.1 $38.0Service cost19.2 20.1 0.7 0.7Interest cost13.0 13.6 1.3 1.6Participant contributions1.0 1.0 0.2 0.2Transferred liabilities16.1 0.5 — —Plan settlements and terminations(7.6) (28.4) — —Actuarial losses (gains)(27.4) 9.3 (0.6) (2.7)Benefits paid(24.9) (24.5) (2.7) (2.5)Impact of foreign currency translation(19.2) 40.7 — (0.2)Projected benefit obligation, end of year$635.4 $665.2 $34.0 $35.1 Change in Plan Assets Fair value of plan assets, beginning of year$296.1 $291.7 $— $—Actual return on plan assets(11.0) 21.7 — —Company contributions28.9 31.5 2.5 2.3Participant contributions1.0 1.0 0.2 0.2Transferred assets16.1 0.5 — —Plan settlements(16.5) (28.0) — —Benefits paid(24.9) (24.5) (2.7) (2.5)Other(1.6) (0.4) — —Impact of foreign currency translation(4.6) 2.6 — —Fair value of plan assets, end of year283.5 296.1 — —Funded status of plans$(351.9) $(369.1) $(34.0) $(35.1)Net accrued benefit costs for pension plans and other postretirement benefits are reported in the following components of the Company’sConsolidated Balance Sheets at December 31, 2018 and 2017: Pension Benefits Other Postretirement Benefits December 31, December 31,(In millions)2018 2017 2018 2017Noncurrent assets$5.9 $6.0 $— $—Current liabilities(11.9) (11.7) (1.7) (1.6)Noncurrent liabilities(345.9) (363.4) (32.3) (33.5)Net accrued benefit costs$(351.9) $(369.1) $(34.0) $(35.1)The projected benefit obligation is the actuarial present value of benefits attributable to employee service rendered to date, including the effects ofestimated future pay increases. The accumulated benefit obligation is the actuarial present value of benefits attributable to employee service rendered to date,but does not include the effects of estimated future pay increases. The accumulated benefit obligation for the Company’s pension plans was $592.5 millionand $598.5 million at December 31, 2018 and 2017, respectively.126Table of ContentsThe projected benefit obligation, accumulated benefit obligation and fair value of plan assets for pension plans with an accumulated benefitobligation in excess of the fair value of plan assets at December 31, 2018 and 2017 were as follows: December 31,(In millions)2018 2017Plans with accumulated benefit obligation in excess of plan assets: Projected benefit obligation$502.9 $530.1Accumulated benefit obligation483.1 506.0Fair value of plan assets154.8 164.8Fair Value of Plan AssetsThe Company measures the fair value of plan assets based on the prices that would be received to sell an asset or paid to transfer a liability in anorderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy described in Note 8Financial Instruments and Risk Management. The table below presents total plan assets by investment category as of December 31, 2018 and 2017 and theclassification of each investment category within the fair value hierarchy with respect to the inputs used to measure fair value: December 31, 2018(In millions)Level 1 Level 2 Level 3 TotalCash and cash equivalents$3.5 $0.4 $— $3.9Equity securities58.5 66.0 — 124.5Fixed income securities65.4 58.4 — 123.8Assets held by insurance companies and other0.1 7.2 24.0 31.3Total$127.5 $132.0 $24.0 $283.5 December 31, 2017(In millions)Level 1 Level 2 Level 3 TotalCash and cash equivalents$2.5 $0.3 $— $2.8Equity securities65.2 71.8 — 137.0Fixed income securities45.2 57.6 — 102.8Assets held by insurance companies and other10.4 23.9 19.2 53.5Total$123.3 $153.6 $19.2 $296.1Risk tolerance on invested pension plan assets is established through careful consideration of plan liabilities, plan funded status and corporatefinancial condition. Investment risk is measured and monitored on an ongoing basis through annual liability measures, periodic asset/liability studies andinvestment portfolio reviews. The Company’s investment strategy is to maintain, where possible, a diversified investment portfolio across several assetclasses that, when combined with the Company’s contributions to the plans, will ensure that required benefit obligations are met.AssumptionsThe following weighted average assumptions were used to determine the benefit obligations for the Company’s defined benefit pension and otherpostretirement plans as of December 31, 2018 and 2017: Pension Benefits Other Postretirement Benefits 2018 2017 2018 2017Discount rate2.3% 2.0% 4.3% 3.7%Expected return on plan assets4.9% 4.9% —% —%Rate of compensation increase2.9% 2.8% —% —%127Table of ContentsThe following weighted average assumptions were used to determine the net periodic benefit cost for the Company’s defined benefit pension andother postretirement benefit plans for the three years in the period ended December 31, 2018: Pension Benefits Other Postretirement Benefits 2018 2017 2016 2018 2017 2016Discount rate2.0% 2.2% 2.1% 3.7% 4.2% 4.2%Expected return on plan assets4.9% 5.0% 4.9% —% —% —%Rate of compensation increase2.9% 2.8% 3.2% —% —% —%The assumptions for each plan are reviewed on an annual basis. The discount rate reflects the current rate at which the pension and other benefitliabilities could be effectively settled at the measurement date. In setting the discount rates, we utilize comparable corporate bond indices as an indication ofinterest rate movements and levels. Corporate bond indices were selected based on individual plan census data and duration. The expected return on planassets was determined using historical market returns and long-term historical relationships between equities and fixed income securities. The Companycompares the expected return on plan assets assumption to actual historic returns to ensure reasonableness. Current market factors such as inflation andinterest rates are also evaluated.The weighted-average healthcare cost trend rate used for 2018 was 7.5% declining to a projected 5.0% in the year 2022. For 2019, the assumedweighted-average healthcare cost trend rate used will be 5.6% declining to a projected 4.5% in the year 2023. In selecting rates for current and long-termhealthcare cost assumptions, the Company takes into consideration a number of factors including the Company’s actual healthcare cost increases, the designof the Company’s benefit programs, the demographics of the Company’s active and retiree populations and external expectations of future medical costinflation rates. If these 2019 healthcare cost trend rates were increased or decreased by one percentage point per year, such increase or decrease would havethe following effects:(In millions)Increase DecreaseIncrease (decrease) in the aggregate of service and interest cost components of annual expense$0.1 $(0.1)Increase (decrease) in the projected benefit obligation1.2 (1.0)Estimated Future Benefit PaymentsThe Company’s funding policy for its funded pension plans is based upon local statutory requirements. The Company’s funding policy is subject tocertain statutory regulations with respect to annual minimum and maximum company contributions. Plan benefits for the nonqualified plans are paid as theycome due.Estimated benefit payments over the next ten years for the Company’s pension plans and retiree health plan are as follows:(In millions)Pension Benefits OtherPostretirementBenefits2019$32.0 $1.7202034.2 1.7202135.7 2.0202234.0 2.3202336.4 2.2Thereafter192.1 11.6Total$364.4 $21.5128Table of ContentsDefined Contribution PlansThe Company sponsors defined contribution plans covering its employees in the U.S. and Puerto Rico, as well as certain employees in a number ofcountries outside the U.S. The Company’s domestic defined contribution plans consist primarily of a 401(k) retirement plan with a profit sharing componentfor non-union represented employees (the “Profit Sharing 401(k) Plan”) and a 401(k) retirement plan for union-represented employees. Profit sharingcontributions are made at the discretion of the Board of Directors. The Company’s non-domestic plans vary in form depending on local legal requirements.The Company’s contributions are based upon employee contributions, service hours, or pre-determined amounts depending upon the plan. Obligations forcontributions to defined contribution plans are recognized as expense in the Consolidated Statements of Operations when they are earned.The Company adopted a 401(k) Restoration Plan (the “Restoration Plan”), which permits employees who earn compensation in excess of the limitsimposed by Section 401(a)(17) of the Code to (i) defer a portion of base salary and bonus compensation, (ii) be credited with a Company matchingcontribution in respect of deferrals under the Restoration Plan, and (iii) be credited with Company non-elective contributions (to the extent so made by theCompany), in each case, to the extent that participants otherwise would be able to defer or be credited with such amounts, as applicable, under the ProfitSharing 401(k) Plan if not for the limits on contributions and deferrals imposed by the Code.The Company adopted an Income Deferral Plan, which permits certain management or highly compensated employees who are designated by theplan administrator to participate in the Income Deferral Plan to elect to defer up to 50% of base salary and up to 100% of bonus compensation, in each case,in addition to any amounts that may be deferred by such participants under the Profit Sharing 401(k) Plan and the Restoration Plan. In addition, under theIncome Deferral Plan, eligible participants may be granted employee deferral awards, which awards will be subject to the terms and conditions (includingvesting) as determined by the plan administrator at the time such awards are granted.Total employer contributions to defined contribution plans were approximately $85.2 million, $95.9 million and $95.6 million for the years endedDecember 31, 2018, 2017 and 2016, respectively.Other Benefit ArrangementsThe Company participated in a multi-employer pension plan under previous collective bargaining agreements. The PACE Industry Union-Management Pension Fund (the “Plan”) provides defined benefits to certain retirees and certain production and maintenance employees at the Company’smanufacturing plant in Morgantown, West Virginia who were covered by the previous collective bargaining agreements. Pursuant to a collective bargainingagreement entered into on April 16, 2012, the Company withdrew from the Plan effective May 10, 2012. In 2013, the Plan trustee notified the Company thatits withdrawal liability was approximately $27.3 million, which was accrued by the Company in 2013. The withdrawal liability is being paid over a period ofapproximately nine years; payments began in March 2014. The withdrawal liability was approximately $15.1 million and $18.1 million at December 31,2018 and 2017, respectively. The Employee Identification Number for the Plan is 11-6166763.14.Segment InformationMylan reports segment information on a geographic basis. This approach reflects the company’s focus on bringing its broad and diversified portfolioof generic, branded generic, brand-name and OTC products to people in markets everywhere. Our North America segment comprises our operations in theU.S. and Canada. Our Europe segment encompasses our operations in 35 countries, including France, Italy, Germany, the U.K. and Spain. Our Rest of Worldsegment reflects our operations in more than 120 countries, including Japan, Australia, China, Brazil, Russia, India, South Africa and certain markets in theMiddle East and Southeast Asia.The Company’s chief operating decision maker is the Chief Executive Officer, who evaluates the performance of its segments based on totalrevenues and segment profitability. Segment profitability represents segment gross profit less direct R&D and direct SG&A. Certain general andadministrative and R&D expenses not allocated to the segments, including certain special items, net charges for litigation settlements and othercontingencies, amortization of intangible assets, impairment charges and other expenses not directly attributable to the segments are reported separately oroutside of segment profitability. Items below the earnings from operations line on the Company’s Consolidated Statements of Operations are not presentedby segment, since they are excluded from the measure of segment profitability. The Company has revised segment profitability for Rest of World to conformwith the current presentation by reclassifying approximately $78.2 million of net gains to litigation settlements and other contingencies for the year endedDecember 31, 2017. The Company does not report depreciation expense, total assets and capital expenditures by segment, as such information is not used bythe chief operating decision maker.129Table of ContentsThe accounting policies of the segments are the same as those described in Note 2 Summary of Significant Accounting Policies. Intersegmentrevenues are accounted for at current market values and are eliminated at the consolidated level.Presented in the table below is segment information for the periods identified and a reconciliation of segment information to total consolidatedinformation.(In millions)North America Europe Rest of World Corporate /Other ConsolidatedYear Ended December 31, 2018 Net sales$4,095.6 $4,157.3 $3,015.8 $— $11,268.7Other revenue112.4 27.1 25.7 — 165.2Intersegment revenue85.2 107.8 343.9 (536.9) —Total$4,293.2 $4,292.2 $3,385.4 $(536.9) $11,433.9 Segment profitability$1,838.4 $1,089.5 $692.0 $— $3,619.9 Intangible asset amortization expense (1,606.4)Intangible asset impairment charges (224.0)Globally managed research and development costs (250.3)Corporate costs and special items (683.1)Litigation settlements & other contingencies 49.5Earnings from operations $905.6 North America Europe Rest of World Corporate /Other ConsolidatedYear Ended December 31, 2017 Net sales$4,969.6 $3,958.3 $2,832.1 $— $11,760.0Other revenue86.5 36.5 24.7 — 147.7Intersegment revenue74.6 112.4 379.2 (566.2) —Total$5,130.7 $4,107.2 $3,236.0 $(566.2) $11,907.7 Segment profitability$2,497.1 $1,082.8 $572.7 $— $4,152.6 Intangible asset amortization expense (1,437.4)Intangible asset impairment charges (80.8)Globally managed research and development costs (356.4)Corporate costs and special items (853.9)Litigation settlements & other contingencies 13.1Earnings from operations $1,437.2130Table of Contents North America Europe Rest of World Corporate /Other ConsolidatedYear Ended December 31, 2016 Net sales$5,629.5 $2,953.8 $2,383.8 $— $10,967.1Other revenue88.4 12.6 8.8 — 109.8Intersegment revenue45.4 106.3 407.6 (559.3) —Total$5,763.3 $3,072.7 $2,800.2 $(559.3) $11,076.9 Segment profitability$2,921.2 $669.4 $423.5 $— $4,014.1 Intangible asset amortization expense (1,195.3)Intangible asset impairment charges (68.3)Globally managed research and development costs (423.7)Corporate costs and special items (955.1)Litigation settlements & other contingencies (672.5)Earnings from operations $699.2The following table represents the percentage of consolidated net sales to Mylan’s major customers during the years ended December 31, 2018,2017, and 2016: Percentage of Consolidated Net Sales 2018 2017 2016McKesson Corporation12% 13% 16%AmerisourceBergen Corporation8% 8% 14%Cardinal Health, Inc.8% 10% 11%Sales by Country InformationNet sales by country are presented on the basis of geographic location of our subsidiaries: Year Ended December 31,(In millions)2018 2017 2016United States$3,865.2 $4,683.7 $5,385.6India1,164.8 1,082.6 985.8The Netherlands (1)132.2 117.5 88.3Other countries (2)6,106.5 5,876.2 4,507.4 $11,268.7 $11,760.0 $10,967.1____________(1) Mylan N.V. has its corporate seat in the Netherlands.(2) No other country’s net sales represents more than 10% of consolidated net sales for the years ended December 31, 2018, 2017 and 2016,respectively.15.CommitmentsOperating LeasesThe Company leases certain property under various operating lease arrangements. These leases generally provide the Company with the option torenew the lease at the end of the lease term. For the years ended December 31, 2018, 2017 and 2016, the Company had operating lease expense ofapproximately $78.9 million, $83.8 million and $70.8 million, respectively.131Table of ContentsFuture minimum lease payments under operating lease commitments are as follows:(In millions) December 31, 2019$73.7202054.7202140.2202228.5202318.3Thereafter54.2 $269.6Other CommitmentsThe Company has also entered into employment and other agreements with certain executives and other employees that provide for compensation,retirement and certain other benefits. These agreements provide for severance payments under certain circumstances. Additionally, the Company has split-dollar life insurance agreements with certain retired executives.In the normal course of business, Mylan periodically enters into employment, legal settlement and other agreements which incorporateindemnification provisions. While the maximum amount to which Mylan may be exposed under such agreements cannot be reasonably estimated, theCompany maintains insurance coverage, which management believes will effectively mitigate the Company’s obligations under these indemnificationprovisions. No amounts have been recorded in the Consolidated Financial Statements with respect to the Company’s obligations under such agreements.16.Subsidiary GuarantorsThe following tables present condensed consolidating financial information for (a) Mylan N.V., the issuer of the 2.500% Senior Notes due 2019,3.750% Senior Notes due 2020, 3.150% Senior Notes due 2021, 3.950% Senior Notes due 2026 and 5.250% Senior Notes due 2046 (collectively, the “MylanN.V. Senior Notes”), which are guaranteed on a senior unsecured basis by Mylan Inc.; (b) Mylan Inc., the issuer of the 3.125% Senior Notes due 2023, 4.200%Senior Notes due 2023, 4.550% Senior Notes due 2028, 5.400% Senior Notes due 2043 and 5.200% Senior Notes due 2048 (collectively, the “Mylan Inc.Senior Notes”), which are guaranteed on a senior unsecured basis by Mylan N.V.; and (c) all other subsidiaries of the Company on a combined basis, none ofwhich guarantee the Mylan N.V. Senior Notes or guarantee the Mylan Inc. Senior Notes (“Non-Guarantor Subsidiaries”). The consolidating adjustmentsprimarily relate to eliminations of investments in subsidiaries and intercompany balances and transactions. The condensed consolidating financial statementspresent investments in subsidiaries using the equity method of accounting.The following financial information presents the related Condensed Consolidating Balance Sheets as of December 31, 2018 and 2017 and therelated Condensed Consolidating Statements of Operations, Condensed Consolidating Statements of Comprehensive Earnings and CondensedConsolidating Statements of Cash Flows for each of the three years in the period ended December 31, 2018. This condensed consolidating financialinformation has been prepared and presented in accordance with SEC Regulation S-X Rule 3-10 “Financial Statements of Guarantors and Issuers ofGuaranteed Securities Registered or Being Registered.”The Company has revised its consolidating balance sheet as previously presented in the 2017 Annual Report on Form 10-K to appropriately presentintercompany activity relating to certain subsidiaries which were included in the Mylan Inc. column. The Company overstated the line items investment insubsidiaries and total equity within the Mylan Inc. column with a corresponding offset to the elimination column. Specifically, the balance sheet captioninvestment in subsidiaries has been revised from the previously reported amount of $15.3 billion as of December 31, 2017 to $13.7 billion with an offset tototal equity. There is no impact to the consolidated financial statements of Mylan N.V. as previously filed in the 2017 Annual Report on Form 10-K.132Table of ContentsCONDENSED CONSOLIDATING BALANCE SHEETAs of December 31, 2018(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedASSETS Assets Current assets: Cash and cash equivalents$— $18.2 $— $369.9 $— $388.1Accounts receivable, net— 24.3 — 2,856.7 — 2,881.0Inventories— — — 2,580.2 — 2,580.2Intercompany receivables342.9 518.7 — 13,107.1 (13,968.7) —Prepaid expenses and other current assets5.6 71.3 — 441.5 — 518.4Total current assets348.5 632.5 — 19,355.4 (13,968.7) 6,367.7Property, plant and equipment, net— 259.7 — 1,910.5 — 2,170.2Investments in subsidiaries18,995.9 13,129.5 — — (32,125.4) —Intercompany notes and interest receivable6,287.4 10,732.6 — 2,519.8 (19,539.8) —Intangible assets, net— — — 13,664.6 — 13,664.6Goodwill— 17.1 — 9,730.7 — 9,747.8Other assets0.3 68.9 — 715.4 — 784.6Total assets$25,632.1 $24,840.3 $— $47,896.4 $(65,633.9) $32,734.9 LIABILITIES AND EQUITY Liabilities Current liabilities: Accounts payable$— $70.6 $— $1,546.4 $— $1,617.0Short-term borrowings— — — 1.9 — 1.9Income taxes payable— — — 121.5 — 121.5Current portion of long-term debt and otherlong-term obligations649.0 0.2 — 50.6 — 699.8Intercompany payables1,618.8 12,326.4 — 23.5 (13,968.7) —Other current liabilities21.0 216.0 — 1,910.6 — 2,147.6Total current liabilities2,288.8 12,613.2 — 3,654.5 (13,968.7) 4,587.8Long-term debt9,370.1 3,786.2 — 4.9 — 13,161.2Intercompany notes payable1,806.1 3,094.2 — 14,639.5 (19,539.8) —Other long-term obligations— 48.6 — 2,770.2 — 2,818.8Total liabilities13,465.0 19,542.2 — 21,069.1 (33,508.5) 20,567.8 Total equity12,167.1 5,298.1 — 26,827.3 (32,125.4) 12,167.1 Total liabilities and equity$25,632.1 $24,840.3 $— $47,896.4 $(65,633.9) $32,734.9133Table of ContentsCONDENSED CONSOLIDATING BALANCE SHEETAs of December 31, 2017(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedASSETS Assets Current assets: Cash and cash equivalents$— $0.2 $— $291.9 $— $292.1Accounts receivable, net— 1.0 — 3,611.4 — 3,612.4Inventories— — — 2,542.7 — 2,542.7Intercompany receivables317.2 462.1 — 11,828.5 (12,607.8) —Prepaid expenses and other current assets5.6 171.1 — 589.4 — 766.1Total current assets322.8 634.4 — 18,863.9 (12,607.8) 7,213.3Property, plant and equipment, net— 294.1 — 2,045.0 — 2,339.1Investments in subsidiaries19,736.5 13,683.3 — — (33,419.8) —Intercompany notes and interest receivable7,822.6 10,271.2 — 2,186.3 (20,280.1) —Intangible assets, net— — — 15,245.8 — 15,245.8Goodwill— 17.1 — 10,188.6 — 10,205.7Other assets4.9 56.5 — 741.0 — 802.4Total assets$27,886.8 $24,956.6 $— $49,270.6 $(66,307.7) $35,806.3 LIABILITIES AND EQUITY Liabilities Current liabilities: Accounts payable$— $45.3 $— $1,407.2 $— $1,452.5Short-term borrowings— — — 46.5 — 46.5Income taxes payable— — — 112.9 — 112.9Current portion of long-term debt and otherlong-term obligations1,097.8 649.1 — 62.0 — 1,808.9Intercompany payables664.7 11,911.5 — 31.6 (12,607.8) —Other current liabilities35.5 397.0 — 2,532.0 — 2,964.5Total current liabilities1,798.0 13,002.9 — 4,192.2 (12,607.8) 6,385.3Long-term debt10,614.3 2,244.5 — 6.5 — 12,865.3Intercompany notes payable2,166.9 3,312.7 — 14,800.5 (20,280.1) —Other long-term obligations— 57.3 — 3,190.8 — 3,248.1Total liabilities14,579.2 18,617.4 — 22,190.0 (32,887.9) 22,498.7 Total equity13,307.6 6,339.2 — 27,080.6 (33,419.8) 13,307.6 Total liabilities and equity$27,886.8 $24,956.6 $— $49,270.6 $(66,307.7) $35,806.3134Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF OPERATIONSYear Ended December 31, 2018(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedRevenues: Net sales$— $— $— $11,268.7 $— $11,268.7Other revenues— — — 165.2 — 165.2Total revenues— — — 11,433.9 — 11,433.9Cost of sales— — — 7,432.3 — 7,432.3Gross profit— — — 4,001.6 — 4,001.6Operating expenses: Research and development— — — 704.5 — 704.5Selling, general and administrative40.7 517.3 — 1,883.0 — 2,441.0Litigation settlements and other contingencies,net— 7.1 — (56.6) — (49.5)Total operating expenses40.7 524.4 — 2,530.9 — 3,096.0(Losses) earnings from operations(40.7) (524.4) — 1,470.7 — 905.6Interest expense349.0 154.6 — 38.7 — 542.3Other (income) expense, net(316.4) (273.3) — 654.6 — 64.9(Losses) earnings before income taxes(73.3) (405.7) — 777.4 — 298.4Income tax (benefit) provision(28.7) (27.4) — 2.0 — (54.1)Earnings of equity interest subsidiaries397.1 328.8 — — (725.9) —Net earnings (loss)$352.5 $(49.5) $— $775.4 $(725.9) $352.5135Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF OPERATIONSYear Ended December 31, 2017(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedRevenues: Net sales$— $— $— $11,760.0 $— $11,760.0Other revenues— — — 147.7 — 147.7Total revenues— — — 11,907.7 — 11,907.7Cost of sales— — — 7,124.6 — 7,124.6Gross profit— — — 4,783.1 — 4,783.1Operating expenses: Research and development— — — 783.3 — 783.3Selling, general and administrative45.5 650.9 — 1,879.3 — 2,575.7Litigation settlements and other contingencies, net— 17.0 — (30.1) — (13.1)Total operating expenses45.5 667.9 — 2,632.5 — 3,345.9(Losses) earnings from operations(45.5) (667.9) — 2,150.6 — 1,437.2Interest expense378.0 104.1 — 52.5 — 534.6Other (income) expense, net(484.9) (264.6) — 749.1 — (0.4)Earnings (losses) before income taxes andnoncontrolling interest61.4 (507.4) — 1,349.0 — 903.0Income tax (benefit) provision(21.1) (14.0) — 242.1 — 207.0Earnings of equity interest subsidiaries613.5 886.4 — — (1,499.9) —Net earnings$696.0 $393.0 $— $1,106.9 $(1,499.9) $696.0136Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF OPERATIONSYear Ended December 31, 2016(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedRevenues: Net sales$— $— $— $10,967.1 $— $10,967.1Other revenues— — — 109.8 — 109.8Total revenues— — — 11,076.9 — 11,076.9Cost of sales— — — 6,379.9 — 6,379.9Gross profit— — — 4,697.0 — 4,697.0Operating expenses: Research and development— — — 826.8 — 826.8Selling, general and administrative71.6 664.1 — 1,762.8 — 2,498.5Litigation settlements and other contingencies, net— — — 672.5 — 672.5Total operating expenses71.6 664.1 — 3,262.1 — 3,997.8(Losses) earnings from operations(71.6) (664.1) — 1,434.9 — 699.2Interest expense198.4 161.3 — 95.1 — 454.8Other (income) expense, net(55.6) (193.2) — 371.5 — 122.7(Losses) earnings before income taxes andnoncontrolling interest(214.4) (632.2) — 968.3 — 121.7Income tax benefit(19.5) (18.2) — (320.6) — (358.3)Earnings of equity interest subsidiaries674.9 1,360.2 — — (2,035.1) —Net earnings$480.0 $746.2 $— $1,288.9 $(2,035.1) $480.0137Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF COMPREHENSIVE EARNINGSYear Ended December 31, 2018(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedNet earnings (loss)$352.5 $(49.5) $— $775.4 $(725.9) $352.5Other comprehensive (loss) earnings, before tax: Foreign currency translation adjustment(1,125.2) — — (1,125.2) 1,125.2 (1,125.2)Change in unrecognized gain and prior servicecost related to defined benefit plans(3.8) 0.6 — (4.4) 3.8 (3.8)Net unrecognized (loss) gain on derivatives incash flow hedging relationships(79.2) 7.7 — (86.9) 79.2 (79.2)Net unrecognized gain on derivatives in netinvestment hedging relationships111.6 11.6 — (11.6) 111.6Net unrealized loss on marketable securities(0.1) — — (0.1) 0.1 (0.1)Other comprehensive (loss) earnings, before tax(1,096.7) 19.9 — (1,216.6) 1,196.7 (1,096.7)Income tax benefit(24.1) (4.7) — (19.4) 24.1 (24.1)Other comprehensive (loss) earnings, net of tax(1,072.6) 24.6 — (1,197.2) 1,172.6 (1,072.6)Comprehensive loss$(720.1) $(24.9) $— $(421.8) $446.7 $(720.1)138Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF COMPREHENSIVE EARNINGSYear Ended December 31, 2017(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedNet earnings$696.0 $393.0 $— $1,106.9 $(1,499.9) $696.0Other comprehensive earnings, before tax: Foreign currency translation adjustment2,103.9 — — 2,103.9 (2,103.9) 2,103.9Change in unrecognized gain and prior servicecost related to defined benefit plans3.8 3.0 — 0.8 (3.8) 3.8Net unrecognized gain on derivatives52.7 7.3 — 45.4 (52.7) 52.7Net unrecognized loss on derivatives in netinvestment hedging relationships(238.4) — — — — (238.4)Net unrealized loss on marketable securities(6.7) (6.4) — (0.3) 6.7 (6.7)Other comprehensive earnings, before tax1,915.3 3.9 — 2,149.8 (2,153.7) 1,915.3Income tax provision (benefit)12.8 (1.6) — 14.4 (12.8) 12.8Other comprehensive earnings, net of tax1,902.5 5.5 — 2,135.4 (2,140.9) 1,902.5Comprehensive earnings$2,598.5 $398.5 $— $3,242.3 $(3,640.8) $2,598.5139Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF COMPREHENSIVE EARNINGSYear Ended December 31, 2016(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedNet earnings$480.0 $746.2 $— $1,288.9 $(2,035.1) $480.0Other comprehensive loss, before tax: Foreign currency translation adjustment(507.4) — — (507.4) 507.4 (507.4)Change in unrecognized gain (loss) and priorservice cost related to defined benefit plans21.4 (1.1) — 22.5 (21.4) 21.4Net unrecognized (loss) gain on derivatives(31.2) (47.7) — 16.5 31.2 (31.2)Net unrecognized loss on derivatives in netinvestment hedging relationships(1.8) — — (1.8) 1.8 (1.8)Net unrealized gain on marketable securities24.6 24.6 — — (24.6) 24.6Other comprehensive loss, before tax(494.4) (24.2) — (470.2) 494.4 (494.4)Income tax provision (benefit)5.0 (9.1) — 4.1 5.0 5.0Other comprehensive loss, net of tax(499.4) (15.1) — (474.3) 489.4 (499.4)Comprehensive (loss) earnings$(19.4) $731.1 $— $814.6 $(1,545.7) $(19.4)140Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF CASH FLOWSYear Ended December 31, 2018(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedCash flows from operating activities: Net cash (used in) provided by operating activities$(230.4) $(1,551.7) $— $4,123.8 $— $2,341.7Cash flows from investing activities: Capital expenditures— (28.6) — (223.5) — (252.1)Cash paid for acquisitions, net of cash acquired— — — (65.9) — (65.9)Proceeds from sale of assets and subsidiaries— — — 29.3 — 29.3Purchase of marketable securities— — — (63.4) — (63.4)Proceeds from the sale of marketable securities— 36.3 — 48.9 — 85.2Investments in affiliates— (28.8) — — 28.8 —Dividends from affiliates118.6 — — — (118.6) —Loans to affiliates(492.2) — — (5,687.8) 6,180.0 —Repayments of loans from affiliates2,615.4 — — 4,066.8 (6,682.2) —Payments for product rights and other, net— (0.5) — (943.0) — (943.5)Net cash provided by (used in) investing activities2,241.8 (21.6) — (2,838.6) (592.0) (1,210.4)Cash flows from financing activities: Payments of financing fees(0.6) (20.8) — — — (21.4)Purchase of ordinary shares(432.0) — — — — (432.0)Change in short-term borrowings, net— — — (44.4) — (44.4)Proceeds from issuance of long-term debt496.5 2,079.2 — 2.2 — 2,577.9Payments of long-term debt(2,012.5) (1,150.0) — (2.7) — (3,165.2)Proceeds from exercise of stock options17.8 — — — — 17.8Taxes paid related to net share settlement of equityawards(10.1) — — — — (10.1)Contingent consideration payments— — — (11.9) — (11.9)Capital contribution from affiliates— — — 28.8 (28.8) —Capital payments to affiliates— — — (118.6) 118.6 —Payments on borrowings from affiliates(1,454.2) (3,691.6) — (1,536.4) 6,682.2 —Proceeds from borrowings from affiliates1,383.7 4,350.9 — 445.4 (6,180.0) —Acquisition of noncontrolling interest— — — (0.6) — (0.6)Other items, net— — — (1.0) — (1.0)Net cash (used in) provided by financing activities(2,011.4) 1,567.7 — (1,239.2) 592.0 (1,090.9)Effect on cash of changes in exchange rates— — — (21.0) — (21.0)Net (decrease) increase in cash, cash equivalents andrestricted cash— (5.6) — 25.0 — 19.4Cash, cash equivalents and restricted cash — beginning ofperiod— 23.8 — 346.1 — 369.9Cash, cash equivalents and restricted cash — end of period$— $18.2 $— $371.1 $— $389.3141Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF CASH FLOWSYear Ended December 31, 2017(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedCash flows from operating activities: Net cash (used in) provided by operating activities$(326.6) $(381.1) $— $2,772.5 $— $2,064.8Cash flows from investing activities: Capital expenditures— (54.8) — (221.1) — (275.9)Cash paid for acquisitions, net of cash acquired(71.6) — — (95.4) — (167.0)Proceeds from sale of assets and subsidiaries— — — 86.7 — 86.7Purchase of marketable securities— — — (96.5) — (96.5)Proceeds from the sale of marketable securities— — — 96.6 — 96.6Investments in affiliates— (30.2) — — 30.2 —Dividends from affiliates261.3 — — — (261.3) —Loans to affiliates(322.7) (98.0) — (3,493.7) 3,914.4 —Repayments of loans from affiliates1,258.8 0.3 — 1,630.9 (2,890.0) —Payments for product rights and other, net— (0.9) — (619.4) — (620.3)Net cash provided by (used in) investing activities1,125.8 (183.6) — (2,711.9) 793.3 (976.4)Cash flows from financing activities: Payments of financing fees(9.7) (0.4) — — — (10.1)Purchase of ordinary shares(500.2) — — — — (500.2)Change in short-term borrowings, net— — — (2.9) — (2.9)Proceeds from issuance of long-term debt874.5 — — 1.6 — 876.1Payments of long-term debt(1,820.0) — — (412.7) — (2,232.7)Proceeds from exercise of stock options17.8 — — — — 17.8Taxes paid related to net share settlement of equityawards(7.4) — — — — (7.4)Contingent consideration payments— — — (26.1) — (26.1)Capital contribution from affiliates— — — 30.2 (30.2) —Capital payments to affiliates— — — (261.3) 261.3 —Payments on borrowings from affiliates— (2,447.2) — (442.8) 2,890.0 —Proceeds from borrowings from affiliates645.5 2,966.7 — 302.2 (3,914.4) —Acquisition of noncontrolling interest— — — (7.5) — (7.5)Other items, net— (16.0) — 15.9 — (0.1)Net cash (used in) provided by financing activities(799.5) 503.1 — (803.4) (793.3) (1,893.1)Effect on cash of changes in exchange rates— — — 27.6 — 27.6Net decrease in cash, cash equivalents and restricted cash(0.3) (61.6) — (715.2) — (777.1)Cash, cash equivalents and restricted cash — beginning ofperiod0.3 85.4 — 1,061.3 — 1,147.0Cash, cash equivalents and restricted cash — end of period$— $23.8 $— $346.1 $— $369.9Supplemental disclosures of cash flow information — Non-cash transactions: Contingent consideration$— $— $— $4.0 $— $4.0142Table of ContentsCONDENSED CONSOLIDATING STATEMENT OF CASH FLOWSYear Ended December 31, 2016(In millions)Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedCash flows from operating activities: Net cash (used in) provided by operating activities$(0.3) $(518.3) $— $2,565.8 $— $2,047.2Cash flows from investing activities: Capital expenditures— (94.4) — (296.0) — (390.4)Cash paid for acquisitions, net of cash acquired(5,608.8) (931.3) — 58.2 — (6,481.9)Cash paid for Meda's unconditional deferred payment— — — (308.0) — (308.0)Settlement of acquisition-related foreign currencyderivatives(128.6) — — — — (128.6)Purchase of marketable securities— (4.3) — (25.9) — (30.2)Proceeds from the sale of marketable securities— — — 21.5 — 21.5Investments in affiliates— (49.6) — — 49.6 —Dividends from affiliates135.6 — — — (135.6) —Loans to affiliates(14,073.5) (530.2) — (3,185.0) 17,788.7 —Repayments of loans from affiliates8,539.6 793.0 — 1,914.1 (11,246.7) —Payments for product rights and other, net— 3.3 — (363.5) — (360.2)Net cash used in investing activities(11,135.7) (813.5) — (2,184.6) 6,456.0 (7,677.8)Cash flows from financing activities: Payments of financing fees(112.6) — — — — (112.6)Change in short-term borrowings, net— — — 40.8 — 40.8Contingent consideration payments— — — (35.5) — (35.5)Proceeds from issuance of long-term debt11,652.6 — — 99.6 — 11,752.2Payments of long-term debt(400.0) (3,400.0) — (2,496.3) — (6,296.3)Proceeds from exercise of stock options13.8 — — — — 13.8Taxes paid related to net share settlement of equityawards(17.5) — — — — (17.5)Capital payments to affiliates— — — (135.6) 135.6 —Capital contribution from affiliates— — — 49.6 (49.6) —Proceeds from borrowings from affiliates— 6,961.2 — 10,827.6 (17,788.8) —Payments on borrowings from affiliates— (3,021.9) — (8,224.9) 11,246.8 —Acquisition of noncontrolling interest— — (1.1) — (1.1)Other items, net— (16.2) — 17.0 — 0.8Net cash provided by financing activities11,136.3 523.1 — 141.2 (6,456.0) 5,344.6Effect on cash of changes in exchange rates— — — (9.6) — (9.6)Net increase (decrease) in cash, cash equivalents andrestricted cash0.3 (808.7) — 512.8 — (295.6)Cash, cash equivalents and restricted cash — beginning ofperiod— 894.1 — 548.5 — 1,442.6Cash, cash equivalents and restricted cash — end of period$0.3 $85.4 $— $1,061.3 $— $1,147.0Supplemental disclosures of cash flow information — Non-cash transactions: Contingent consideration$— $— $— $16.0 $— $16.0Ordinary shares issued for acquisition$1,281.7 $— $— $— $— $1,281.7143Table of ContentsThe following tables provide a reconciliation of cash and cash equivalents, as reported on our Condensed Consolidating Balance Sheets, to cash,cash equivalents and restricted cash, as reported on our Condensed Consolidating Statements of Cash Flows (in millions): December 31, 2018 Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedCash and cash equivalents$— $18.2 $— $369.9 $— $388.1Restricted cash, included in prepaid expenses andother current assets— — — 1.2 — 1.2Cash, cash equivalents and restricted cash$— $18.2 $— $371.1 $— $389.3 December 31, 2017 Mylan N.V. Mylan Inc. GuarantorSubsidiaries Non-GuarantorSubsidiaries Eliminations ConsolidatedCash and cash equivalents$— $0.2 $— $291.9 $— $292.1Restricted cash, included in prepaid expenses andother current assets— 23.6 — 54.2 — 77.8Cash, cash equivalents and restricted cash$— $23.8 $— $346.1 $— $369.9144Table of Contents17.RestructuringOn December 5, 2016, the Company announced a restructuring program representing initial steps of a series of actions in certain locations that areanticipated to further streamline its operations globally. Since 2015, the Company has made a number of significant acquisitions, and as part of the holistic,global integration of these acquisitions, the Company is focused on how to best optimize and maximize all of its assets across the organization and across allgeographies.Charges for restructuring and ongoing cost reduction initiatives are recorded in the period the Company commits to a restructuring or cost reductionplan, or executes specific actions contemplated by the plan and all criteria for liability recognition have been met.During the second quarter of 2018, the Company commenced comprehensive restructuring and remediation activities, which are aimed at reducingthe complexity at the Morgantown, West Virginia plant and include the discontinuation and transfer to other manufacturing sites of a number of products, areduction of the workforce and extensive process and facility remediation. The restructuring actions other than for this plant were substantially complete as ofDecember 31, 2018. At this time, the expenses related to the additional restructuring activities at the Morgantown, West Virginia plant cannot be reasonablyestimated.The following table summarizes the restructuring charges and the reserve activity from December 31, 2016 to December 31, 2018:(In millions)EmployeeRelated Costs Other Exit Costs TotalBalance at December 31, 2016:$138.6 $1.6 $140.2Charges107.4 80.6 188.0Cash payment(150.0) (2.4) (152.4)Reclassifications(8.3) 8.3 —Utilization— (74.4) (74.4)Foreign currency translation$5.2 $0.4 $5.6Balance at December 31, 2017:$92.9 $14.1 $107.0Charges (1)71.6 168.6 240.2Cash payment(100.8) (26.1) (126.9)Utilization— (144.5) (144.5)Foreign currency translation(2.9) (0.3) (3.2)Balance at December 31, 2018$60.8 $11.8 $72.6____________(1)For the year ended December 31, 2018, total restructuring charges in North America, Europe, Rest of World and corporate were approximately$129.1 million, $73.4 million, $16.2 million and $21.5 million, respectively. For the year ended December 31, 2017, total restructuring charges inNorth America, Europe, Rest of World and corporate were approximately $48.0 million, $70.1 million, $36.5 million and $33.4 million respectively.At December 31, 2018 and 2017, accrued liabilities for restructuring and other cost reduction programs were primarily included in other currentliabilities on the Consolidated Balance Sheets.18.Collaboration and Licensing AgreementsWe periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture,marketing and/or sale of pharmaceutical products. Our significant collaboration agreements are primarily focused on the development, manufacturing, supplyand commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other complexproducts. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of ourlicensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction orachievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone paymentobligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities inthe Consolidated Balance Sheets, except145Table of Contentsfor milestone and royalty obligations reflected as acquisition related contingent consideration. Refer to Note 8 Financial Instruments and Risk Managementfor further discussion of contingent consideration. Our potential maximum development milestones not accrued for at December 31, 2018 totaledapproximately $425 million. We estimate that the amounts that may be paid in the next twelve months to be approximately $35 million. These agreementsmay also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profitshare. The amounts disclosed do not include sales-based milestones or royalty obligations on future sales of product as the timing and amount of future saleslevels and costs to produce products subject to these obligations is not reasonably estimable. These sales-based milestones or royalty obligations may besignificant depending upon the level of commercial sales for each product.Respiratory Delivery PlatformOn December 23, 2011, the Company completed the acquisition of the respiratory delivery platform. Under the agreement, the development programfor the respiratory delivery platform was transferred to the Company along with exclusive licenses and assignments of the intellectual property effective fromthe closing date. The Company is responsible for all development costs after the closing date. The Company will also lead the commercialization efforts incertain territories, including the U.S. and Europe. Pfizer is eligible to receive milestone payments, which are contingent upon the future product developmentachievements including regulatory approvals, market launches, sales targets and profitability. On January 30, 2019, the Company received FDA approval ofWixelaTM InhubTM (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of GlaxoSmithKline’s Advair Diskus®. The commerciallaunch of the WixelaTM InhubTM occurred in February 2019.In accordance with U.S. GAAP guidance regarding business combinations, the Company accounted for this transaction as a purchase of a businessand utilized the acquisition method of accounting. Under the acquisition method of accounting, the assets acquired and liabilities assumed in the transactionwere recorded at the date of acquisition at the estimate of their respective fair values. The fair value of the contingent consideration liability related to theestimate of future profit sharing and milestone payments was $336.5 million at December 31, 2018. These payments are contingent upon the occurrence ofcertain future events and the ultimate success of the respective projects. We estimate the amount of development milestones that may be paid in the nexttwelve months to be approximately $60 million, a portion of which is accrued as contingent consideration. Given the inherent uncertainty of these events, itis unclear when we may be required to pay such amounts or pay amounts in excess of those accrued.MomentaOn January 8, 2016, the Company entered into an agreement with Momenta Pharmaceuticals, Inc. (“Momenta”) to develop, manufacture andcommercialize up to six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate, ORENCIA® (abatacept) (“ORENCIA®”).Mylan paid an up-front cash payment of $45 million to Momenta. Under the terms of the agreement, the Company and Momenta are jointly responsible forproduct development and equally share in the costs and profits of the products with Mylan leading the worldwide commercialization efforts.Under the terms of the agreement, Momenta was eligible to receive additional contingent milestone payments for the development of biosimilarcandidates. The Company paid $60 million related to certain milestones in 2016. There were no milestone payments in 2017 or 2018.On November 1, 2017, the Company and Momenta announced that M834 did not meet its primary pharmacokinetic (PK) endpoints in the Phase 1study to compare the pharmacokinetics, safety and immunogenicity of M834 to U.S.- and European Union (“EU”)-sourced ORENCIA® in normal healthyvolunteers.On January 3, 2018, the Company and Momenta announced the development strategy for M710, a proposed biosimilar to EYLEA® (aflibercept)(“EYLEA®”) injection. EYLEA® is the market-leading vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet)age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabeticmacular edema.On October 1, 2018, Momenta announced that it had initiated discussions with Mylan to exit its participation in the development of five biosimilarprograms including M834, a proposed biosimilar to ORENCIA®. The parties have agreed to the termination of all collaboration activities, except for thecontinued development of M710, a proposed biosimilar to EYLEA®. The Company remains committed to invest strategically in biosimilar programsthrough the evaluation of regulatory data and market dynamics. The Company does not anticipate making any additional continuation payments toMomenta.146Table of ContentsIn accordance with ASC 730, Research and Development and based upon the cost sharing provisions of the agreement, the Company accounted forthe contingent milestone payments related to the Momenta collaboration as non-refundable advance payments for services to be used in future R&Dactivities, which were required to be capitalized until the related services have been performed. More specifically, as costs were incurred within the scope ofthe collaboration, the Company recorded its share of the costs as R&D expense. In addition to the upfront cash payment, during the years endedDecember 31, 2018, 2017, and 2016, the Company incurred R&D expense related to this collaboration of approximately $13.4 million, $31.9 million and$29.2 million, respectively. To the extent the contingent milestone payments made by the Company exceeded the liability incurred, a prepaid asset wasreflected on the Company’s Consolidated Balance Sheets. To the extent the contingent milestone payments made by the Company were less than theexpense incurred, the difference between the payment and the expense was recorded as a liability on the Company’s Consolidated Balance Sheets. AtDecember 31, 2018, there was no significant recorded prepaid asset or accrued liability on the Consolidated Balance Sheet.TheravanceOn January 30, 2015, the Company entered into a development and commercialization collaboration with Theravance Biopharma, Inc.(“Theravance Biopharma”) for the development and, subject to FDA approval, commercialization of Revefenacin (“TD-4208”). Under the terms of theagreement, Mylan and Theravance Biopharma are co-developing nebulized TD-4208 for chronic obstructive pulmonary disease (“COPD”) and otherrespiratory diseases. Theravance Biopharma is leading the U.S. registrational development program and Mylan was responsible for the reimbursement ofTheravance Biopharma’s development costs for that program up until the approval of the first new drug application (“NDA”). On November 9, 2018, Mylanannounced that the FDA approved the NDA for YUPELRITM (revefenacin) inhalation solution for the maintenance treatment of patients with COPD.YUPELRI, a long-acting muscarinic antagonist (LAMA), is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in theU.S. The commercial launch of YUPELRI occurred in the fourth quarter of 2018. Mylan is responsible for commercial manufacturing and commercialization.Theravance Biopharma is co-promoting the product in the hospital channel under a profit-sharing arrangement.Under the terms of the agreement, Theravance Biopharma is eligible to receive potential development and sales milestone payments totaling $220million in the aggregate. As of December 31, 2018, Mylan has paid a total of $30 million in milestone payments to Theravance Biopharma.BioconThe Company has entered into exclusive collaborations with Biocon Limited (“Biocon”) on the development, manufacturing, supply andcommercialization of multiple, high value biosimilar compounds and three insulin analog products for the global marketplace. Under the agreements withBiocon, Mylan has exclusive commercialization rights for the products under the collaborations in the U.S., Canada, Japan, Australia, New Zealand and inthe EU and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the products in the rest of theworld.In December 2017, the FDA approved Mylan's Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab). Ogivri has been approved forall indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastaticstomach cancer (gastric or gastroesophageal junction adenocarcinoma). Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar fromMylan and Biocon's joint portfolio approved in the U.S. Mylan anticipates potentially being the first company to commercialize a biosimilar to Herceptin. InDecember 2018, the Company received final approval from the European Commission to market Ogivri in all 28 EU member states and the EuropeanEconomic Area.On June 4, 2018, Mylan and Biocon announced that the FDA approved Mylan's Fulphila™ (pegfilgrastim-jmdb), a biosimilar toNeulasta® (pegfilgrastim). Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count ofneutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer. The commercial launch of Fulphila occurred in thesecond quarter of 2018.The Company continues to provide development funding related to this collaboration. As the timing of cash expenditures is dependent upon anumber of factors, many of which are out of the Company’s control, it is difficult to forecast the amount of payments to be made over the next few years,which could be significant.147Table of ContentsFKBOn February 22, 2018, the Company entered into a collaboration license and distribution agreement with FKB for the distribution of Hulio™, abiosimilar to AbbVie's Humira® (adalimumab). Under the agreement, Mylan has exclusive commercialization rights for the product in the EU and theEuropean Economic Area countries and FKB is responsible for development, manufacturing and supply of the product.On September 20, 2018, the Company received final approval from the European Commission (the “Commission”) to market Hulio for alladalimumab indications in all 28 EU member states and the European Economic Area. Under the agreement, FKB received an upfront payment of $25.0million, an approval milestone of $10.0 million and is eligible for a royalty based upon net sales.We are actively pursuing, and are currently involved in, joint projects related to the development, distribution and marketing of both generic andbranded products. Many of these arrangements provide for payments by us upon the attainment of specified milestones. While these arrangements help toreduce the financial risk for unsuccessful projects, fulfillment of specified milestones or the occurrence of other obligations may result in fluctuations in cashflows and R&D expense.19.LitigationThe Company is involved in various disputes, governmental and/or regulatory inquiries, investigations and proceedings, tax proceedings andlitigation matters, both in the U.S. and abroad, that arise from time to time, some of which could result in losses, including damages, fines and/or civilpenalties, and/or criminal charges against the Company. These matters are often complex and have outcomes that are difficult to predict. The Company isalso party to certain proceedings and litigation matters for which it may be entitled to indemnification under the respective sale and purchase agreementsrelating to the acquisitions of the former Merck Generics business, Agila, Abbott Laboratories’ (“Abbott”) non-U.S. developed markets specialty and brandedgenerics business, and certain other acquisitions.While the Company believes that it has meritorious defenses with respect to the claims asserted against it and intends to vigorously defend itsposition, the process of resolving these matters is inherently uncertain and may develop over a long period of time, and so it is not possible to predict theultimate resolution of any such matter. It is possible that an unfavorable resolution of any of the ongoing matters or the inability or denial of Merck KGaA,Strides Arcolab, Abbott, or another indemnitor or insurer to pay an indemnified claim, could have a material effect on the Company’s business, financialcondition, results of operations, cash flows and/or ordinary share price.Some of these governmental inquiries, investigations, proceedings and litigation matters with which the Company is involved are described below,and unless otherwise disclosed, the Company is unable to predict the outcome of the matter or to provide an estimate of the range of reasonably possiblematerial losses. The Company records accruals for loss contingencies to the extent we conclude it is probable that a liability has been incurred and theamount of the loss can be reasonably estimated. The Company is also involved in other pending proceedings for which, in the opinion of the Company basedupon facts and circumstances known at the time, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of suchproceedings is not expected to be material to the Company’s business, financial position, results of operations, cash flows and/or ordinary share price. If andwhen any reasonably possible losses associated with the resolution of such other pending proceedings, in the opinion of the Company, become material, theCompany will disclose such matters.Legal costs are recorded as incurred and are classified in SG&A in the Company’s Consolidated Statements of Operations.Lorazepam and ClorazepateOn June 1, 2005, a jury verdict was rendered against Mylan, MPI, and co-defendants Cambrex Corporation and Gyma Laboratories in theU.S. District Court for the District of Columbia in the amount of approximately $12.0 million in an antitrust case brought by four health insurers who optedout of earlier class action settlements agreed to by the Company in 2001. The Court entered final judgment on August 30, 2017 in the amount ofapproximately $67.0 million (not including post-judgment interest and fees and costs). Mylan filed a notice of appeal on September 15, 2017 with the UnitedStates Court of Appeals for the District of Columbia Circuit. This matter has been resolved by way of settlement and the case is closed. The Company paidapproximately $34.5 million during 2018 related to this matter.The Company maintained a surety bond underwritten by a third-party insurance company in the amount of $66.6 million which has been released.148Table of ContentsPricing and Medicaid LitigationDey L.P. (now known as Mylan Specialty L.P. and herein as “Mylan Specialty”), a wholly owned subsidiary of the Company, was named in 1997 asa defendant in a case brought by the U.S. as well as in later filed class actions brought by consumers and third-party payors. All of the cases and claimsbrought against Mylan Specialty have been fully resolved and dismissed.Under the terms of the purchase agreement with Merck KGaA, Mylan is fully indemnified for the claims in the preceding paragraph and MerckKGaA is entitled to any income tax benefit the Company realizes for any deductions of amounts paid for such pricing litigation. The Company paidapproximately $65.7 million in 2018. No further amounts are owed by the Company.Modafinil Antitrust LitigationBeginning in April 2006, Mylan and four other drug manufacturers were named as defendants in civil lawsuits filed in or transferred to the U.S.District Court for the Eastern District of Pennsylvania (“EDPA”) by a variety of plaintiffs purportedly representing direct and indirect purchasers of the drugmodafinil and in a lawsuit filed by Apotex, Inc., a manufacturer of generic drugs. These actions alleged violations of federal antitrust and state laws inconnection with the generic defendants’ settlement of patent litigation with Cephalon relating to modafinil. Mylan entered into a settlement agreement withthe putative indirect purchasers for approximately $16.0 million, which is subject to court approval. Mylan has settled with the putative direct purchaserclass and the retailer opt-out plaintiffs for $165 million, a portion of which was paid by the Company prior to 2018, and a final amount of approximately$89.2 million was paid in April 2018. Mylan and Apotex have also settled Apotex’s claims. The Company has also received subpoenas from certain stateattorneys general requesting documents related to the modafinil patent litigation.On July 10, 2015, the Louisiana Attorney General filed in the 19th Judicial District Court in Louisiana a petition against Mylan and three other drugmanufacturers asserting state law claims based on the same underlying allegations as those made in the litigation then pending in the EDPA. On December 8,2016, Mylan’s peremptory exceptions of no cause of action with respect to the supplemental and amended petition were granted in their entirety and withprejudice. The State of Louisiana appealed this decision. The First Circuit Court of Appeal subsequently returned the case to the District Court withinstructions to include certain decretal language in order to make the District Court’s decision final and appealable.On July 28, 2016, United Healthcare filed a complaint against Mylan Inc. and four other drug manufacturers in the United States District Court forthe District of Minnesota, asserting state law claims based on the same underlying allegations as those made in the litigation then pending in the EDPA. OnJanuary 6, 2017, the case was transferred to the EDPA and is still pending. MPI has since been included as an additional party. A trial date has been scheduledfor July 2019.The Company believes that it has strong defenses to these remaining cases. Although it is reasonably possible that the Company may incuradditional losses from these matters, any amount cannot be reasonably estimated at this time.The Company has a total accrual of approximately $16.0 million related to this matter at December 31, 2018, which is included in other currentliabilities in the Consolidated Balance Sheets.PioglitazoneBeginning in December 2013, Mylan, Takeda, and several other drug manufacturers have been named as defendants in civil lawsuits consolidated inthe U.S. District Court for the Southern District of New York by plaintiffs which purport to represent direct and indirect purchasers of branded or genericActos® and Actoplus Met®. These actions allege violations of state and federal competition laws in connection with the defendants’ settlements of patentlitigation in 2010 related to Actos® and Actoplus Met®. Mylan’s motion to dismiss the indirect purchasers’ complaint was granted and no appeal was filedas to Mylan. Following the appellate decision relating to other defendants, the direct purchasers filed an amended complaint against Mylan and the othermanufacturers. Mylan’s motion to dismiss the amended complaint is pending.SEC InvestigationOn September 10, 2015, Mylan N.V. received a subpoena from the SEC’s Division of Enforcement seeking documents with regard to certain relatedparty matters. Mylan subsequently received additional requests for information. The SEC’s Division of Enforcement has informed the Company that it hascompleted its investigation with no recommended further action.149Table of ContentsTrade Agreements Act (“TAA”)On April 9, 2018, a subsidiary of Mylan N.V. received a civil investigative demand from the Commercial Litigation Branch of the U.S. Departmentof Justice (“DOJ”) concerning its TAA compliance for certain products. The company fully cooperated with DOJ. On September 14, 2018, the United StatesDistrict Court for the Southern District of Ohio unsealed a qui tam lawsuit filed against the Mylan N.V. subsidiary concerning its TAA compliance for thesame products identified in DOJ’s civil investigative demand. DOJ has declined to intervene in the lawsuit and has closed its investigation. The lawsuit hasbeen stayed and we believe that its claims are without merit and intend to defend against them vigorously.EpiPen® Auto-Injector and Certain Congressional MattersClassification of EpiPen® Auto-Injector and EpiPen Jr® Auto-InjectorIn November 2014, the Company received a subpoena from the DOJ related to the classification of the EpiPen® Auto-Injector for purposes of theMedicaid Drug Rebate Program (“MDRP”). On August 17, 2017, two of Mylan’s subsidiaries - Mylan Inc. and Mylan Specialty - signed an agreement for a$465 million settlement, plus interest, with the DOJ, state government agencies and two relators (the “MDRP Settlement”). The settlement with the DOJ, tworelators and all 50 states plus the District of Columbia has been completed and both the federal and state matters have been dismissed through stipulations ofdismissal. In connection with the settlement, Mylan Inc. and Mylan Specialty entered into a Corporate Integrity Agreement (the “CIA”) with the Office ofInspector General of the Department of Health and Human Services. The CIA has a five-year term and requires, among other things, that an independentreview organization annually review various matters relating to the MDRP. Neither the settlement agreement nor the CIA contains an admission or finding ofwrongdoing. In connection with the settlement, Mylan Specialty has reclassified EpiPen® Auto-Injector as an innovator product for purposes of the MDRPeffective April 1, 2017. The Company recorded an accrual for the full settlement amount during the year ended December 31, 2016 and recorded anadditional accrual for interest related to the settlement amount prior to the payment made in 2017.Department of Veterans Affairs Request for InformationOn June 30, 2017, the Company responded to a request for information from the Department of Veterans Affairs (“VA”) (acting on behalf of itselfand other government agencies) requesting certain historical pricing data related to the EpiPen® Auto-Injector. The Company and the VA are engaged in acontinuing dialogue regarding the classification of the EpiPen® Auto-Injector as a covered drug under Section 603 of the Veterans Health Care Act of 1992,Public Law 102-585. The EpiPen® Auto-Injector has been classified as a non covered drug with the VA based upon long standing written guidance from thefederal government. The Company is fully cooperating with the VA.SEC Request for Information/SubpoenasOn October 7, 2016, Mylan received a document request from the SEC’s Division of Enforcement seeking communications with the Centers forMedicare and Medicaid Services and documents concerning Mylan products sold and related to the MDRP, and any related complaints. On November 15,2016, Mylan received a follow-up letter, modifying the initial document request, seeking information on and public disclosures regarding the MDRPSettlement and the classification of the EpiPen® Auto-Injector under the MDRP. Mylan has received subpoenas and additional requests for information inthis matter and will continue to fully cooperate with the SEC.On April 25, 2017, Mylan received a comment letter from the staff of the SEC’s Division of Corporation Finance (“Corporation Finance”) withrespect to Mylan’s Annual Report on Form 10-K for the year ended December 31, 2016, requesting information regarding Mylan’s accounting treatment ofthe MDRP Settlement, including with respect to the determinations that the settlement amount should be recorded as a charge against earnings in the thirdquarter of 2016 rather than against any earlier periods, and that the settlement amount should be classified as an expense rather than a reduction of revenue.The Company responded to the comment letter in May 2017 and we will continue to respond to any additional correspondence from Corporation Finance.We believe that our accounting treatment for the aforementioned settlement is appropriate and consistent with all applicable accounting standards.FTC Request for InformationOn November 18, 2016, Mylan received a request from the U.S. Federal Trade Commission (“FTC”) Bureau of Competition seeking documents andinformation relating to its preliminary investigation into potential anticompetitive practices relating to epinephrine auto-injectors. Mylan is fullycooperating with the FTC.150Table of ContentsFederal Securities LitigationPurported class action complaints were filed in October 2016 against Mylan N.V., Mylan Inc. and certain of their current and former directors andofficers (collectively, for purposes of this paragraph, the “defendants”) in the United States District Court for the Southern District of New York on behalf ofcertain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ. The complaints alleged that defendants made false or misleadingstatements and omissions of purportedly material fact, in violation of federal securities laws, in connection with disclosures relating to Mylan N.V. andMylan Inc.’s classification of their EpiPen® Auto-Injector as a non-innovator drug for purposes of the MDRP. The complaints sought damages, as well as theplaintiffs’ fees and costs. On March 20, 2017, after the actions were consolidated, a consolidated amended complaint was filed, alleging substantially similarclaims and seeking substantially similar relief, but adding allegations that defendants made false or misleading statements and omissions of purportedlymaterial fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violationsof both federal securities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. and/or Mylan Inc. on the NASDAQ) and Israelisecurities laws (on behalf of a purported class of certain purchasers of securities of Mylan N.V. on the Tel Aviv Stock Exchange). On March 28, 2018,defendants’ motion to dismiss the consolidated amended complaint was granted in part (including the dismissal of claims arising under Israeli securities laws)and denied in part. On July 6, 2018, the Plaintiffs filed a second amended complaint, including certain current and former directors and officers andadditional allegations in connection with purportedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs. On August6, 2018, defendants filed a motion to dismiss the second amended complaint, which is currently pending. We believe that the claims in this lawsuit arewithout merit and intend to defend against them vigorously.Israeli Securities LitigationOn October 13, 2016, a purported shareholder of Mylan N.V. filed a lawsuit, together with a motion to certify the lawsuit as a class action on behalfof certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, against Mylan N.V. and four of its directors and officers (collectively, for purposes ofthis paragraph, the “defendants”) in the Tel Aviv District Court (Economic Division) (the “Friedman Action”). The plaintiff alleges that the defendants madefalse or misleading statements and omissions of purportedly material fact in Mylan N.V.’s reports to the Tel Aviv Stock Exchange regarding Mylan N.V.’sclassification of its EpiPen® Auto-Injector for purposes of the MDRP, in violation of both U.S. and Israeli securities laws, the Israeli Companies Law and theIsraeli Torts Ordinance. The plaintiff seeks damages, among other remedies. On April 30, 2017, another purported shareholder of Mylan N.V. filed a separatelawsuit, together with a motion to certify the lawsuit as a class action on behalf of certain Mylan N.V. shareholders on the Tel Aviv Stock Exchange, in theTel Aviv District Court (Economic Division), alleging substantially similar claims and seeking substantially similar relief against the defendants and otherdirectors and officers of Mylan N.V., but alleging also that this group of defendants made false or misleading statements and omissions of purportedlymaterial fact in connection with allegedly anticompetitive conduct with respect to EpiPen® Auto-Injector and certain generic drugs, and alleging violationsof both U.S. federal securities laws and Israeli law (the “IEC Fund Action”). On April 10, 2018, the Tel Aviv District Court granted the motion filed byplaintiffs in both the Friedman Action and the IEC Fund Action, voluntarily dismissing the Friedman Action and staying the IEC Fund Action until ajudgment is issued in the securities litigation pending in the U.S. We believe that the claims in these lawsuits are without merit and intend to defend againstthem vigorously.EpiPen® Auto-Injector Civil LitigationMylan Specialty and other Mylan-affiliated entities have been named as defendants in putative class actions relating to the pricing and/or marketingof the EpiPen® Auto-Injector. The plaintiffs in these cases assert violations of various federal and state antitrust and consumer protection laws, the RacketeerInfluenced and Corrupt Organizations Act, as well as common law claims. Plaintiffs’ claims include purported challenges to the prices charged for theEpiPen® Auto-Injector and/or the marketing of the product in packages containing two auto-injectors, as well as allegedly anti-competitive conduct. AMylan officer and other non-Mylan affiliated companies were also named as defendants in some of the class actions. These lawsuits were filed in the variousfederal and state courts and have either been dismissed or transferred into a multidistrict litigation (“MDL”) in the U.S. District Court for the District ofKansas and have been consolidated. Mylan filed a motion to dismiss the consolidated amended complaint, which was granted in part and denied in part. OnDecember 7, 2018, the Plaintiffs filed a motion for class certification. This motion remains pending. A trial date has been scheduled for July 2020. We believethat the remaining claims in these lawsuits are without merit and intend to defend against them vigorously.On April 24, 2017, Sanofi-Aventis U.S., LLC (“Sanofi”) filed a lawsuit against Mylan Inc. and Mylan Specialty in the U.S. District Court for theDistrict of New Jersey. This lawsuit has been transferred into the aforementioned MDL. In this lawsuit, Sanofi alleges exclusive dealings and anti-competitivemarketing practices in violation of the antitrust laws in connection with the sale and marketing of the EpiPen® Auto-Injector. On November 1, 2018, Sanofifiled a Motion for a151Table of ContentsSuggestion of Remand of the case to the U.S. District Court for the District of New Jersey. On January 23, 2019, the Court denied Sanofi’s motion withoutprejudice. We believe that Sanofi’s claims in this lawsuit are without merit and intend to defend against them vigorously.EpiPen® Auto-Injector State AG InvestigationsThe Company and certain of its affiliated entities received subpoenas and informal requests from various state attorneys general seeking informationand documents relating to the pricing and/or marketing of the EpiPen® Auto-Injector. The Company has cooperated and is fully cooperating with the variousstate attorneys general.U.S. Congress/State Requests for Information and DocumentsMylan received several requests for information and documents from various Committees of the U.S. Congress and federal and state lawmakersconcerning the marketing, distribution and sales of Mylan products. Mylan cooperated with federal and state lawmakers as appropriate in response to theirrequests.The Company has a total accrual of approximately $10.0 million related to this matter at December 31, 2018, which is included in other currentliabilities in the Consolidated Balance Sheets. During the year ended December 31, 2018, the Company made payments of approximately $472.7 millionrelated to this matter. The Company believes that it has strong defenses to current and future potential civil litigation, as well as governmental investigationsand enforcement proceedings, discussed in this “EpiPen® Auto-Injector and Certain Congressional Matters” section of this Note 19 Litigation. Although it isreasonably possible that the Company may incur additional losses from these matters, any amount cannot be reasonably estimated at this time. In addition,the Company expects to incur additional legal and other professional service expenses associated with such matters in future periods and will recognize theseexpenses as services are received. The Company believes that the ultimate amount paid for these services and claims could have a material effect on theCompany's business, financial condition, results of operations, cash flows and/or ordinary share price in future periods.OpioidsOn July 27, 2017, Mylan N.V. received a subpoena from the DOJ seeking information relating to opioids manufactured, marketed or sold by Mylanduring the period from January 1, 2013 to December 31, 2016. On August 29, 2017, Mylan N.V. received a civil investigative demand from the AttorneyGeneral of the State of Missouri seeking information relating to opioids manufactured, marketed or sold by Mylan during the period from January 1, 2010 tothe present and related subject matter. Mylan is fully cooperating with these subpoena requests.Mylan has been named in the U.S. and Canada, along with numerous other manufacturers, distributors, pharmacies, pharmacy benefit managers,and/or individual healthcare professionals, in civil lawsuits, including certain cases in the MDL pending in the United States District Court for the NorthernDistrict of Ohio, brought by plaintiffs, including local governmental entities, generally asserting statutory and/or common law claims arising from themanufacture, distribution, marketing, promotion, and sale of purported prescription opioids. The lawsuits seek damages, including punitive and/or exemplarydamages, injunctive relief, attorneys’ fees and costs, and other relief. Mylan believes that the claims in these lawsuits are without merit and intends to defendagainst them vigorously.Drug Pricing MattersDepartment of JusticeOn December 3, 2015, a subsidiary of Mylan N.V. received a subpoena from the Antitrust Division of the DOJ seeking information relating to themarketing, pricing, and sale of our generic Doxycycline products and any communications with competitors about such products.On September 8, 2016, a subsidiary of Mylan N.V., as well as certain employees and a member of senior management, received subpoenas from theDOJ seeking additional information relating to the marketing, pricing and sale of our generic Cidofovir, Glipizide-metformin, Propranolol and Verapamilproducts and any communications with competitors about such products. Related search warrants also were executed.On May 10, 2018, a subsidiary of Mylan N.V. received a civil investigative demand from the Civil Division of the DOJ seeking information relatingto the pricing and sale of its generic drug products.152Table of ContentsThe Company is fully cooperating with the DOJ.Civil LitigationBeginning in 2016, the Company, along with other manufacturers, has been named as a defendant in lawsuits generally alleging anticompetitiveconduct with respect to generic drugs. The lawsuits have been filed by putative classes of direct purchasers, indirect purchasers, and indirect resellers, as wellas individual direct and indirect purchasers. They allege harm under federal and state antitrust laws, state consumer protection laws and unjust enrichmentclaims. Some of the lawsuits also name Mylan’s President as a defendant and include allegations against him with respect to doxycycline hyclate delayedrelease. The lawsuits have been consolidated in an MDL proceeding in the EDPA. The Court has sequenced these lawsuits into separate groups for purposesof briefing motions to dismiss. Defendants filed motions to dismiss complaints in the first group. On October 16, 2018, the Court denied the motions withrespect to the federal law claims. On February 15, 2019, the Court granted in part and denied in part the motions with respect to the state law claims. TheCompany believes that the claims in these lawsuits are without merit and intends to defend against them vigorously.Attorneys General LitigationOn December 21, 2015, the Company received a subpoena and interrogatories from the Connecticut Office of the Attorney General seekinginformation relating to the marketing, pricing and sale of certain of the Company’s generic products (including generic doxycycline) and communicationswith competitors about such products. On December 14, 2016, attorneys general of twenty states filed a complaint in the United States District Court for theDistrict of Connecticut against several generic pharmaceutical drug manufacturers, including Mylan, alleging anticompetitive conduct with respect to,among other things, doxycycline hyclate delayed release. The complaint was subsequently amended to add certain attorneys general alleging violations offederal and state antitrust laws, as well as violations of various states’ consumer protection laws. This lawsuit has been transferred to the aforementioned MDLproceeding in the EDPA. On October 31, 2017, attorneys general of forty-five states, the District of Columbia and the Commonwealth of Puerto Rico filed amotion for leave to file a consolidated amended complaint (“proposed amended complaint”) against various drug manufacturers, including Mylan. Theproposed amended complaint was permitted and was filed on June 18, 2018 and included two additional states. Mylan is alleged to have engaged inanticompetitive conduct with respect to doxycycline hyclate delayed release, doxycycline monohydrate, glipizide-metformin, and verapamil. The amendedcomplaint also includes claims asserted by attorneys general of thirty-seven states and the Commonwealth of Puerto Rico against certain individuals,including Mylan’s President, with respect to doxycycline hyclate delayed release. The allegations in the amended complaint are similar to those in thepreviously filed complaints. We believe that the claims in this lawsuit are without merit and intend to defend against them vigorously.ValsartanMylan N.V., and three of its subsidiaries (Mylan Inc., Mylan Laboratories Ltd. and Mylan Pharmaceuticals Inc.), along with numerous othermanufacturers, retailers and others, have been named as defendants in lawsuits in the United States and Israel stemming from recalls of valsartan-containingmedications. The litigation, which will take place in an MDL in the District of New Jersey, includes class action allegations seeking the refund of thepurchase price and other economic damages allegedly sustained by consumers who purchased valsartan-containing products as well as claims for personalinjuries allegedly caused by ingestion of the medication. Moreover, Mylan has received requests to indemnify purchasers of Mylan’s active pharmaceuticalingredient and/or finished dose forms of the product. We believe that the claims in these lawsuits are without merit and intend to defend against themvigorously.European Commission ProceedingsPerindoprilOn July 9, 2014, the Commission issued a decision finding that Mylan Laboratories Limited and Mylan, as well as several other companies, hadviolated EU competition rules relating to the product Perindopril and fined Mylan Laboratories Limited approximately €17.2 million, includingapproximately €8.0 million jointly and severally with Mylan Inc. The Company paid approximately $21.7 million related to this matter during the fourthquarter of 2014. In September 2014, the Company filed an appeal of the Commission’s decision to the General Court of the EU. A hearing on the appealbefore the General Court of the EU was held in June 2017 and the Commission’s decision was affirmed. Mylan is preparing to appeal this decision to theEuropean Court of Justice (“CJEU”).153Table of ContentsCitalopramOn June 19, 2013, the Commission issued a decision finding that Generics [U.K.] Limited,(“GUK”) as well as several other companies, had violatedEU competition rules relating to the product Citalopram and fined GUK approximately €7.8 million, jointly and severally with Merck KGaA. GUK appealedthe Commission’s decision to the General Court of the EU. The case is currently on appeal to the CJEU. The U.K. applied and was granted permission tointervene in this proceeding. The Company has accrued approximately €7.4 million as of December 31, 2018 and 2017, respectively related to this matter.GUK has received notices from European national health services and health insurers stating an intention to commence follow-on litigation and assertingdamages. GUK has also sought indemnification from Merck KGaA with respect to the €7.8 million portion of the fine for which Merck KGaA and GUK wereheld jointly and severally liable. Merck KGaA has counterclaimed against GUK seeking the same indemnification. In June 2018, the Frankfurt RegionalCourt issued a judgment dismissing GUK claims against Merck KGaA and ordered GUK to indemnify Merck KGaA with respect to the amount for which theparties were held jointly and severally liable. GUK has appealed this decision. A hearing took place on January 24, 2019. It is reasonably possible that wewill incur additional losses above the amount accrued but we cannot estimate a range of such reasonably possible losses at this time. There are no assurances,however, that settlements reached and/or adverse judgments received, if any, will not exceed amounts accrued.U.K. Competition and Markets AuthorityParoxetineOn August 12, 2011, GUK received notice that the Office of Fair Trading (subsequently changed to the Competition and Markets Authority (the“CMA”)) opened an investigation to explore the possible infringement of the Competition Act 1998 and Articles 101 and 102 of the Treaty on theFunctioning of the EU, with respect to alleged agreements related to Paroxetine. The CMA issued a decision on February 12, 2016, finding that, GUK, MerckKGaA and other companies were liable for infringing EU and U.K. competition rules. With respect to Merck KGaA and GUK, the CMA issued a penalty ofapproximately £5.8 million, for which Merck KGaA is liable for the entire amount; and of that amount GUK is jointly and severally liable for approximately£2.7 million, which has been accrued for as of December 31, 2018. The matter is currently on appeal to the Competition Appeals Tribunal, which on March 8,2018, referred certain questions of law to the CJEU. The CJEU sought written observations from GUK, which were filed in September 2018.NefopamOn October 10, 2017, Mylan N.V. and Meda Pharmaceuticals Limited received notice that the CMA was opening an investigation to explore thepossible infringement of the Competition Act 1998 and Article 101 of the Treaty on the Functioning of the EU, with respect to alleged agreements related toNefopam, a product from Meda’s portfolio. On October 16, 2017, the CMA issued a notice under Section 26 of the Competition Act 1998 to Mylan N.V. andMeda Pharmaceuticals Limited to provide specified information and produce specified documents. The CMA has closed its investigation with no action.Italy InvestigationOn April 18, 2018, certain employees of Mylan S.p.A. were served with search warrants issued by the Public Prosecutor’s Office in Milan, Italyseeking information concerning interactions with an Italian hospital and sales of certain reimbursable Mylan S.p.A. drugs. The Company is assisting itsemployees in their cooperation with the investigation. 154Table of ContentsProduct LiabilityThe Company is involved in a number of product liability lawsuits and claims related to alleged personal injuries arising out of certain productsmanufactured and/or distributed by the Company. The Company believes that it has meritorious defenses to these lawsuits and claims and is vigorouslydefending itself with respect to those matters. From time to time, the Company has agreed to settle or otherwise resolve certain lawsuits and claims on termsand conditions that are in the best interests of the Company. The Company has accrued approximately $10.9 million and $8.4 million at December 31, 2018and December 31, 2017, respectively. It is reasonably possible that we will incur additional losses and fees above the amount accrued but we cannot estimatea range of such reasonably possible losses or legal fees related to these claims at this time. There are no assurances, however, that settlements reached and/oradverse judgments received, if any, will not exceed amounts accrued.Intellectual PropertyMPI filed with the FDA a Paragraph IV certification stating that approval of MPI’s Abbreviated New Drug Application (“ANDA”) for glatirameracetate injection, 20 mg/mL will not infringe any valid claim of patents owned or controlled by Teva Pharmaceuticals USA, Inc., Yeda Research andDevelopment Co., or their affiliates (for purposes of these paragraphs, “Plaintiffs”), listed in the FDA’s Orange Book. There are currently no unexpired patentsfor the product listed in the FDA’s Orange Book. On October 3, 2017, MPI received final FDA approval and launched its 20 mg/mL glatiramer acetateproduct in the U.S.MPI filed with the FDA a Paragraph IV certification stating that approval of MPI’s ANDA for glatiramer acetate injection, 40 mg/mL will not infringeany valid claim of patents owned or controlled by the Plaintiffs listed in the FDA’s Orange Book. On October 6, 2014, Plaintiffs filed suit against MPI andMylan Inc. in the District Court for the District of Delaware alleging infringement of the Orange Book patents and seeking monetary damages, injunctiverelief, attorneys’ fees, costs and other relief. On January 30, 2017, the Delaware District Court found, after trial, the asserted claims of the Orange Bookpatents-in-suit invalid as obvious.In February and March 2015, MPI and Mylan Inc. filed petitions with the Patent Trial and Appeal Board requesting inter partes review of the claimsof three asserted patents. On August 24, 2016 and September 1, 2016, respectively, the Patent Trial and Appeal Board issued final written decisions findingall claims of three asserted patents unpatentable as obvious. After Plaintiffs’ requests for reconsideration of those decisions, the Patent Trial and Appeal Boardissued revised final written decisions addressing issues raised in the requests for reconsideration and again finding all claims of three asserted patentsunpatentable as obvious.Plaintiffs appealed both the District Court decision and the Patent and Trial and Appeal Board decision to the Federal Circuit. On October 12, 2018,the Federal Circuit affirmed both decisions finding the asserted claims of the Orange Book-listed patents invalid. No further appeals were filed, and alldeadlines have passed.On October 19, 2017, Teva Pharmaceutical Industries Ltd. (“Teva”) commenced an action with the Irish High Court against Mylan Teoranta allegingthat Mylan’s glatiramer acetate 40mg/mL product, which is manufactured in Ireland, approved by the FDA and is currently being sold in the U.S., infringestwo European patents, EP (IE) 2 949 335 and EP (IE) 3 050 556. Teva subsequently dropped its infringement allegation related to the EP (IE) 3 050 556patent. Teva is seeking damages and/or an account of profits from Mylan for the alleged infringement. Teva has also requested the Irish High Court to enjoinMylan Teoranta from making, offering, putting on the market and/or using its glatiramer acetate 40mg/mL product in Ireland pending final determination ofthe action. On June 5, 2018, the Irish High Court refused Teva’s request for an injunction pending final determination. Teva has appealed the decision and aninjunction appeal hearing is scheduled for June 26, 2019. A main trial on the infringement and validity of the 335 patent is scheduled to begin on July 9,2019.On September 22, 2017, Amgen Inc. and Amgen Manufacturing Limited (“Amgen”) sued Mylan Inc., Mylan N.V., Mylan GMBH, and MPI in theWestern District of Pennsylvania asserting that Mylan’s Fulphila® infringes U.S. patent numbers 8,273,707 and 9,643,997. On June 4, 2018, the FDAapproved Mylan’s Fulphila® (pegfilgrastim-jmdb), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. In July 2018, Mylan began sellingFulphila®. Amgen is seeking monetary damages, injunctive relief, attorneys’ fees, costs and other relief. No trial date is currently scheduled.On July 31, 2015, BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC (“Janssen”)sued Mylan Inc. and Mylan Pharmaceuticals, Inc., along with numerous other ANDA applicants, in the District of New Jersey asserting that Mylan’s and theother ANDA applicants’ abiraterone acetate ANDA products infringe U.S. Patent number 8,822,438 (“’438”). On June 30, 2016, Mylan filed an Inter PartesReview (“IPR”)155Table of Contentspetition challenging the validity of the ’438 patents’ claims. On January 17, 2018, the U.S. Patent and Trademark Appeal Board (“PTAB”) issued FinalWritten Decisions in the IPR finding all claims of the ’438 patent unpatentable as obvious. On October 26, 2018, the district court issued an opinionsimilarly finding the ’438 patents’ claims invalid as obvious. On October 31, 2018, the FDA approved Mylan’s abiraterone acetate ANDA. Mylan, alongwith certain other ANDA applicants, began selling their abiraterone acetate ANDA products in November.Janssen has appealed both the district court and IPR decisions to the Federal Circuit. Both matters have been consolidated and a hearing is set onthe appeals for March 14, 2019. Janssen is seeking monetary damages, injunctive relief, attorneys’ fees, costs and other relief, including pre- and post-judgment interest. Janssen is further asserting that the district court erred in not enforcing estoppel provisions against the prevailing ANDA filers in the IPRproceedings.The Company has used its business judgment in connection with the decision to launch the 40mg/mL glatiramer acetate, Fulphila® and abirateroneacetate products and has also used its business judgment in certain other situations to decide to market and sell products, in each case based on its belief thatthe applicable patents are invalid and/or that its products do not infringe, notwithstanding the fact that allegations of patent infringement(s) or otherpotential third party rights have not been finally resolved by the courts. The risk involved in doing so can be substantial because the remedies available tothe owner of a patent for infringement may include, a reasonable royalty on sales or damages measured by the profits lost by the patent owner. If there is afinding of willful infringement, damages may be increased up to three times. Moreover, because of the discount pricing typically involved withbioequivalent products, patented branded products generally realize a substantially higher profit margin than generic and biosimilar products. Mylan intendsto defend against any such patent infringement claims vigorously. However, an adverse decision could have an adverse effect that is material to our business,financial condition, results of operations, cash flows and/or ordinary share price.Other LitigationThe Company is involved in various other legal proceedings that are considered normal to its business. The Company has approximately $5.5 millionaccrued related to these various other legal proceedings at December 31, 2018.156Table of ContentsMylan N.V.Supplementary Financial InformationQuarterly Financial Data(Unaudited, in millions, except per share data)Year Ended December 31, 2018 Three-Month Period Ended March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018Total revenues$2,684.5 $2,808.3 $2,862.4 $3,078.7Gross profit984.3 962.5 1,039.2 1,015.6Net earnings87.1 37.5 176.7 51.2Earnings per share (1): Basic$0.17 $0.07 $0.34 $0.10Diluted$0.17 $0.07 $0.34 $0.10Share prices (2): High$47.64 $41.86 $39.48 $37.15Low$38.87 $35.37 $35.53 $26.21Year Ended December 31, 2017 Three-Month Period Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017Total revenues$2,719.5 $2,962.2 $2,987.1 $3,238.9Gross profit1,085.0 1,225.4 1,178.1 1,294.6Net earnings66.4 297.0 88.3 244.3Earnings per share (1): Basic$0.12 $0.56 $0.17 $0.46Diluted$0.12 $0.55 $0.16 $0.46Share prices (2): High$45.28 $40.09 $39.49 $42.31Low$35.81 $36.72 $29.63 $32.39____________ (1) The sum of earnings per share for the quarters may not equal earnings per share for the total year due to changes in the average number of ordinaryshares outstanding.(2) Closing prices are as reported on NASDAQ.157Table of ContentsITEM 9.Changes in and Disagreements with Accountants on Accounting and Financial DisclosuresNone.ITEM 9A.Controls and ProceduresAn evaluation was performed under the supervision and with the participation of the Company’s management, including the Principal ExecutiveOfficer and the Principal Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as ofDecember 31, 2018. Based upon that evaluation, the Principal Executive Officer and the Principal Financial Officer concluded that the Company’s disclosurecontrols and procedures were effective.Management has not identified any changes in the Company’s internal control over financial reporting that occurred during the fourth quarter of2018 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.Management’s Report on Internal Control over Financial Reporting is on page 71, which is incorporated herein by reference. The effectiveness ofthe Company’s internal control over financial reporting as of December 31, 2018 has been audited by Deloitte & Touche LLP, an independent registeredpublic accounting firm, as stated in their report on page 73, which is incorporated herein by reference.ITEM 9B.Other InformationCredit Agreement AmendmentsOn February 22, 2019, the Company, as a guarantor, and Mylan Inc., as borrower, entered into the Revolving Loan Amendment to the 2018Revolving Facility. In addition, on February 22, 2019, the Company entered into the Term Loan Amendment to the 2016 Term Facility. The Revolving LoanAmendment and the Term Loan Amendment extended the leverage ratio covenant of 4.25 to 1.00 through the December 31, 2019 reporting period, with aleverage ratio of 3.75 to 1.00 thereafter. The Company is in compliance at December 31, 2018 and expects to remain in compliance for the next twelvemonths.The foregoing description does not purport to be complete and is qualified in its entirety by reference to the Revolving Loan Amendment and theTerm Loan Amendment, which are attached hereto as Exhibit 10.34(b) and Exhibit 10.35(c), respectively, and which are incorporated herein by reference.Agreements with Named Executive OfficersOn February 25, 2019, Mylan extended the employment agreements of Heather Bresch, Chief Executive Officer, Rajiv Malik, President, Ken Parks,Chief Financial Officer, and Anthony Mauro, Chief Commercial Officer. The term of the agreements extends through April 1, 2024 for Ms. Bresch andthrough April 1, 2022 for each of Messrs. Malik, Parks and Mauro, and each will renew for successive one-year terms thereafter. Pursuant to the extendedagreements, base salaries are $1,500,000 for Ms. Bresch, $1,150,000 for Mr. Malik, and $800,000 for Messrs. Parks and Mauro. Ms. Bresch is eligible for atarget annual bonus of 150% of base salary and Messrs. Malik, Parks and Mauro are eligible for target annual bonuses of 125%, 115% and 115% of basesalary, respectively.As previously disclosed on February 11, 2019, Daniel M. Gallagher, Chief Legal Officer, informed Mylan that he intends to return to private practicein the Washington, D.C. area at the conclusion of the current term of his employment agreement in April 2019. On February 25, 2019, Mylan and Mr.Gallagher entered into a consulting agreement setting forth the terms of his separation and continuing consulting role for up to 12 months following theseparation date. Mr. Gallagher will receive (i) a cash payment of $800,000 payable pursuant to his employment agreement, (ii) payments of $50,000 permonth in consideration of the consulting services to be provided, (iii) eligibility for continued vesting of 32,354 time-based restricted stock units andunvested retirement plan contributions through the term of the consulting agreement and (iv) continued medical and welfare benefits through the 12 monthanniversary of his separation pursuant to his employment agreement.This description of the employment agreements and consulting agreement is qualified by reference to the provisions of the applicable agreements,copies of which are filed as exhibits to this Annual Report on Form 10-K.158Table of ContentsPART IIIITEM 10.Directors, Executive Officers and Corporate GovernanceCertain information required by this Item will be provided in an amendment to this Annual Report on Form 10-K in accordance with GeneralInstruction G(3) to Form 10-K.Code of EthicsThe Mylan board of directors has adopted a Code of Ethics for the Company’s Chief Executive Officer, Chief Financial Officer and Controller. TheMylan board of directors also has adopted a Code of Business Conduct and Ethics applicable to all directors, officers, and employees. The Code of Ethics forour Chief Executive Officer, Chief Financial Officer and Controller and the Code of Business Conduct and Ethics are posted on Mylan’s website athttp://www.mylan.com/company/corporate-governance, and Mylan intends to post any amendments to and waivers from each of the Code of Ethics for theCompany’s Chief Executive Officer, Chief Financial Officer and Controller and the Code of Business Conduct and Ethics that are required to be disclosed onthat website.ITEM 11.Executive CompensationThe information required by this Item will be provided in an amendment to this Annual Report on Form 10-K in accordance with General InstructionG(3) to Form 10-K.ITEM 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder MattersThe additional information required by this Item will be provided in an amendment to this Form 10-K in accordance with General Instruction G(3) toForm 10-K.Equity Compensation Plan InformationThe following table shows information about the securities authorized for issuance under Mylan’s equity compensation plans as of December 31,2018: Number of Securities to beIssued upon Exercise ofOutstanding Options,Warrants and Rights(a) Weighted-Average ExercisePrice of OutstandingOptions, Warrants andRights(b) Number of SecuritiesRemaining Available forFuture Issuance UnderEquity Compensation Plans(excluding securities reflectedin column (a))(c)Plan Category Equity compensation plans approved by securityholders13,208,359 $38.61 7,953,085Equity compensation plans not approved by securityholders— — —Total13,208,359 $38.61 7,953,085ITEM 13.Certain Relationships and Related Transactions, and Director IndependenceThe information required by this Item will be provided in an amendment to this Annual Report on Form 10-K in accordance with General InstructionG(3) to Form 10-K.ITEM 14.Principal Accounting Fees and ServicesThe information required by this Item will be provided in an amendment to this Annual Report on Form 10-K in accordance with General InstructionG(3) to Form 10-K.159Table of ContentsPART IVITEM 15.Exhibits, Consolidated Financial Statement Schedules1.Consolidated Financial StatementsThe Consolidated Financial Statements listed in the Index to Consolidated Financial Statements are filed as part of this Form.2.Consolidated Financial Statement SchedulesMYLAN N.V. AND SUBSIDIARIESSCHEDULE II — VALUATION AND QUALIFYING ACCOUNTS(In millions)DescriptionBeginningBalance Additions Charged toCosts and Expenses AdditionsChargedtoOtherAccounts (1) Deductions EndingBalanceAllowance for doubtful accounts: Year ended December 31, 2018$75.3 32.3 0.2 (9.6) $98.2Year ended December 31, 2017$59.0 16.8 6.0 (6.5) $75.3Year ended December 31, 2016$33.6 15.6 13.0 (3.2) $59.0Valuation allowance for deferred tax assets: Year ended December 31, 2018$662.8 203.8 — (60.6) $806.0Year ended December 31, 2017$460.7 194.1 18.9 (10.9) $662.8Year ended December 31, 2016$355.7 108.8 3.4 (7.2) $460.7____________(1) In 2016, this amount includes opening balances of businesses acquired in the period.3.Exhibits2.1 Amended and Restated Business Transfer Agreement and Plan of Merger, dated November 4, 2014, between and among AbbottLaboratories, Mylan Inc., New Moon B.V. and Moon of PA Inc., filed as Annex A to the Registration Statement on Form S-4 filed withthe SEC on November 5, 2014, as amended on December 9 and December 23, 2014, and incorporated herein by reference.^2.2(a) Irrevocable Undertaking, dated February 10, 2016, between Mylan N.V. and Stena Sessan Rederi AB, filed as Exhibit 2.1 to the Reporton Form 8-K filed with the SEC on February 17, 2016, and incorporated herein by reference.2.2(b) Irrevocable Undertaking, dated February 10, 2016, between Mylan N.V. and Fidim S.r.l., filed as Exhibit 2.2 to the Report on Form 8-Kfiled with the SEC on February 17, 2016, and incorporated herein by reference.2.2(c) Shareholder Agreement, dated February 10, 2016, between Mylan N.V. and Stena Sessan Rederi AB, filed as Exhibit 2.3 to the Reporton Form 8-K filed with the SEC on February 17, 2016, and incorporated herein by reference.^2.2(d) Shareholder Agreement, dated February 10, 2016, between Mylan N.V. and Fidim S.r.l., filed as Exhibit 2.4 to the Report on Form 8-Kfiled with the SEC on February 17, 2016, and incorporated herein by reference.^3.1 Amended and Restated Articles of Association of Mylan N.V., filed as Exhibit 3.1 to the Report on Form 8-K filed with the SEC onFebruary 27, 2015, and incorporated herein by reference.160Table of Contents4.1(a) Indenture, dated December 21, 2012, between and among Mylan Inc., the guarantors named therein, and The Bank of New YorkMellon, as trustee, filed by Mylan Inc. as Exhibit 4.1 to the Report on Form 8-K filed with the SEC on December 24, 2012, andincorporated herein by reference.4.1(b) First Supplemental Indenture, dated February 27, 2015, between and among Mylan Inc., as Issuer, Mylan N.V., as Guarantor, and TheBank of New York Mellon, as Trustee, to the Indenture, dated December 21, 2012, filed as Exhibit 4.4 to the Report on Form 8-K filedwith the SEC on February 27, 2015, and incorporated herein by reference.4.1(c) Second Supplemental Indenture, dated March 12, 2015, between and among Mylan Inc., as Issuer, Mylan N.V., as Parent, and TheBank of New York Mellon, as Trustee, to the Indenture, dated December 21, 2012, filed as Exhibit 4.3(b) to Form 10-Q for the quarterended March 31, 2015, and incorporated herein by reference.4.2(a) Indenture, dated June 25, 2013, among Mylan Inc., the guarantors thereto and The Bank of New York Mellon, as trustee, filed byMylan Inc. as Exhibit 4.1 to the Report on Form 8-K filed with the SEC on June 27, 2013, and incorporated herein by reference.4.2(b) First Supplemental Indenture, dated February 27, 2015, between and among Mylan Inc., as Issuer, Mylan N.V., as Guarantor, and TheBank of New York Mellon, as Trustee, to the Indenture, dated June 25, 2013, filed as Exhibit 4.5 to the Report on Form 8-K filed withthe SEC on February 27, 2015, and incorporated herein by reference.4.2(c) Second Supplemental Indenture, dated March 12, 2015, between and among Mylan Inc., as Issuer, Mylan N.V., as Parent, and TheBank of New York Mellon, as Trustee, to the Indenture, dated June 25, 2013, filed as Exhibit 4.4(b) to Form 10-Q for the quarter endedMarch 31, 2015, and incorporated herein by reference.4.3(a) Indenture, dated November 29, 2013, by and between Mylan Inc. and The Bank of New York Mellon, as trustee, filed by Mylan Inc. asExhibit 4.1 to the Report on Form 8-K filed with the SEC on November 29, 2013, and incorporated herein by reference.4.3(b) First Supplemental Indenture, dated November 29, 2013, by and between Mylan Inc. and The Bank of New York Mellon, as trustee,filed by Mylan Inc. as Exhibit 4.2 to the Report on Form 8-K filed with the SEC on November 29, 2013, and incorporated herein byreference.4.3(c) Second Supplemental Indenture, dated February 27, 2015, between and among Mylan Inc., as Issuer, Mylan N.V., as Guarantor, andThe Bank of New York Mellon, as Trustee, to the Indenture, dated November 29, 2013, filed as Exhibit 4.6 to the Report on Form 8-Kfiled with the SEC on February 27, 2015, and incorporated herein by reference.4.3(d) Third Supplemental Indenture, dated March 12, 2015, between and among Mylan Inc., as Issuer, Mylan N.V., as Parent, and The Bankof New York Mellon, as Trustee, to the Indenture, dated November 29, 2013, filed as Exhibit 4.5(b) to Form 10-Q for the quarter endedMarch 31, 2015, and incorporated herein by reference.4.4 Indenture, dated as of December 9, 2015, among Mylan N.V., Mylan Inc., as guarantor, and The Bank of New York Mellon, as trustee,filed as Exhibit 4.1 to the Report on Form 8-K filed with the SEC on December 15, 2015, and incorporated herein by reference.4.5 Indenture, dated as of June 9, 2016, among Mylan N.V., as issuer, Mylan Inc., as guarantor, and The Bank of New York Mellon, astrustee, filed as Exhibit 4.1 to the Report on Form 8-K filed with the SEC on June 15, 2016, and incorporated herein by reference.4.6 Indenture, dated November 22, 2016, among Mylan N.V., as issuer, Mylan, Inc., as guarantor and Citibank, N.A., London Branch, astrustee, filed as Exhibit 4.9 to Form 10-K for the fiscal year ended December 31, 2016, and incorporated herein by reference.4.7 Indenture, dated as of May 24, 2017, among Mylan N.V., as issuer, Mylan Inc., as guarantor, and Citibank, N.A., London Branch, astrustee, filed as Exhibit 4.1 to the Report on Form 8-K filed with the SEC on May 31, 2017, and incorporated herein by reference.4.8 Indenture, dated as of April 9, 2018, among Mylan Inc., Mylan N.V., as guarantor, and the Bank of New York Mellon, as trustee, filedas Exhibit 4.1 to the Report on Form 8-K filed with the SEC on April 9, 2018, and incorporated herein by reference.4.9 Indenture, dated as of May 23, 2018, among Mylan Inc., Mylan N.V., as guarantor, and Citibank, N.A., London Branch, as trustee,paying agent, transfer agent and registrar, filed as Exhibit 4.1 to the Report on Form 8-K filed with the SEC on May 23, 2018, andincorporated herein by reference.161Table of Contents10.1(a) Amended and Restated 2003 Long-Term Incentive Plan, filed as Appendix B to the Definitive Proxy Statement on Schedule 14A filedon May 25, 2016, and incorporated herein by reference.*10.1(b) Amendment to Amended and Restated 2003 Long-Term Incentive Plan, filed as Appendix B to the Definitive Proxy Statement onSchedule 14A filed on May 25, 2016, and incorporated herein by reference.*10.1(c) Amended and Restated Form of Stock Option Agreement under the 2003 Long-Term Incentive Plan for Robert J. Coury, HeatherBresch, and Rajiv Malik, filed by Mylan Inc. as Exhibit 10.2 to Form 10-Q for the quarter ended September 30, 2013, and incorporatedherein by reference.*10.1(d) Amended and Restated Form of Stock Option Agreement under the 2003 Long-Term Incentive Plan for awards granted following fiscalyear 2012, filed by Mylan Inc. as Exhibit 10.4(i) to Form 10-K for the fiscal year ended December 31, 2013, and incorporated herein byreference.*10.1(e) Form of Stock Option Agreement under the 2003 Long-Term Incentive Plan for Robert J. Coury, Heather Bresch, and Rajiv Malik forawards granted after February 27, 2015, filed as Exhibit 10.1(i) to Form 10-K for the fiscal year ended December 31, 2015, andincorporated herein by reference.*10.1(f) Form of Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch and Rajiv Malik forawards granted after February 27, 2015, filed as Exhibit 10.1(j) to Form 10-K for the fiscal year ended December 31, 2015, andincorporated herein by reference.*10.1(g) Form of Performance-Based Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch andRajiv Malik for awards granted after February 27, 2015, filed as Exhibit 10.1(k) to Form 10-K for the fiscal year ended December 31,2015, and incorporated herein by reference.*10.1(h) Form of Stock Option Agreement under the 2003 Long-Term Incentive Plan for awards granted after February 27, 2015, filed asExhibit 10.1(l) to Form 10-K for the fiscal year ended December 31, 2015, and incorporated herein by reference.*10.1(i) Form of Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for awards granted after February 27, 2015,filed as Exhibit 10.1(m) to Form 10-K for the fiscal year ended December 31, 2015, and incorporated herein by reference.*10.1(j) Form of Performance-Based Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for awards granted afterFebruary 27, 2015, filed as Exhibit 10.1(n) to Form 10-K for the fiscal year ended December 31, 2015, and incorporated herein byreference.*10.1(k) Amendment to Amended and Restated 2003 Long-Term Incentive Plan, adopted as of February 23, 2017, filed as Exhibit 10.1 to Form10-Q for the quarter ended March 31, 2017, and incorporated herein by reference.*10.1(l) Form of Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch and Rajiv Malik forawards granted on or after February 23, 2017, filed as Exhibit 10.2 to Form 10-Q for the quarter ended March 31, 2017, andincorporated herein by reference.*10.1(m) Form of Performance-Based Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch andRajiv Malik for awards granted on or after February 23, 2017, filed as Exhibit 10.3 to Form 10-Q for the quarter ended March 31, 2017,and incorporated herein by reference.*10.1(n) Form of Performance-Based Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for Heather Bresch andRajiv Malik for awards granted on or after February 21, 2018, filed as Exhibit 10.2 to Form 10-Q for the quarter ended March 31, 2018,and incorporated herein by reference.*10.1(o) Form of Performance-Based Restricted Stock Unit Award Agreement under the 2003 Long-Term Incentive Plan for awards granted onor after February 21, 2018, filed as Exhibit 10.3 to Form 10-Q for the quarter ended March 31, 2018, and incorporated herein byreference.*10.2(a) Mylan Inc. Severance Plan, amended as of August, 2009, filed by Mylan Inc. as Exhibit 10.6 to Form 10-Q for the quarter endedSeptember 30, 2009, and incorporated herein by reference.*10.2(b) Amendment to Mylan Inc. Severance Plan, dated July 13, 2014, filed by Mylan Inc. as Exhibit 10.1 to Form 10-Q for the quarter endedSeptember 30, 2014, and incorporated herein by reference.*162Table of Contents10.3(a) Retirement Benefit Agreement, dated December 31, 2004, between Mylan Inc. and Robert J. Coury, filed by Mylan Inc. as Exhibit 10.7to Form 10-Q for the quarter ended December 31, 2004, and incorporated herein by reference.*10.3(b) Amendment to Retirement Benefit Agreement, dated April 3, 2006, between Mylan Inc. and Robert J. Coury, filed by Mylan Inc. asExhibit 10.11(b) to Form 10-K for the fiscal year ended March 31, 2006, and incorporated herein by reference.*10.3(c) Amendment to Retirement Benefit Agreement, dated December 22, 2008, between Mylan Inc. and Robert J. Coury, filed by Mylan Inc.as Exhibit 10.20(c) to Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.*10.3(d) Amendment to Retirement Benefit Agreement, dated March 3, 2010, by and between Mylan Inc. and Robert J. Coury, filed by MylanInc. as Exhibit 10.1 to Form 8-K filed with the SEC on March 5, 2010, and incorporated herein by reference.*10.3(e) Amendment to Retirement Benefit Agreement, effective as of January 1, 2012, by and between Mylan Inc. and Robert J. Coury, filedby Mylan Inc. as Exhibit 10.6 to Form 8-K filed with the SEC on October 28, 2011, and incorporated herein by reference.*10.3(f) Amendment to Retirement Benefit Agreement, effective as of January 1, 2014, by and between Mylan Inc. and Robert J. Coury, filedby Mylan Inc. as Exhibit 10.2 to the Report on Form 8-K filed with the SEC on February 28, 2014, and incorporated herein byreference.*10.4 Retirement Benefit Agreement, dated August 31, 2009, by and between Mylan Inc. and Heather Bresch filed by Mylan Inc. as Exhibit10.3 to Form 10-Q for the quarter ended September 30, 2009, and incorporated herein by reference.*10.5 Retirement Benefit Agreement, dated August 31, 2009, by and between Mylan Inc. and Rajiv Malik, filed by Mylan Inc. as Exhibit10.4 to Form 10-Q for the quarter ended September 30, 2009, and incorporated herein by reference.*10.6 Form of Retirement Benefit Agreement Waiver Letter by and between Mylan Inc. and certain executive officers of Mylan Inc., filed byMylan Inc. as Exhibit 10.58 to Form 10-K for the fiscal year ended December 31, 2014, and incorporated herein by reference.*10.7(a) Transition and Succession Agreement, dated December 15, 2003, between Mylan Inc. and Robert J. Coury, filed by Mylan Inc. asExhibit 10.19 to Form 10-Q for the quarter ended December 31, 2003, and incorporated herein by reference.*10.7(b) Amendment No. 1 to Transition and Succession Agreement, dated December 2, 2004, between Mylan Inc. and Robert J. Coury, filed byMylan Inc. as Exhibit 10.1 to Form 10-Q for the quarter ended December 31, 2004, and incorporated herein by reference.*10.7(c) Amendment No. 2 to Transition and Succession Agreement, dated April 3, 2006, between Mylan Inc. and Robert J. Coury filed byMylan Inc. as Exhibit 10.19(c) to Form 10-K for the fiscal year ended March 31, 2006, and incorporated herein by reference.*10.7(d) Amendment No. 3 to Transition and Succession Agreement, dated December 22, 2008, between Mylan Inc. and Robert J. Coury, filedby Mylan Inc. as Exhibit 10.25(d) to Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.*10.8(a) Amended and Restated Transition and Succession Agreement, dated December 31, 2007, between Mylan Inc. and Heather Bresch, filedby Mylan Inc. as Exhibit 10.2 to Form 10-Q for the quarter ended March 31, 2008, and incorporated herein by reference.*10.8(b) Amendment No. 1 to Transition and Succession Agreement, dated December 22, 2008, between Mylan Inc. and Heather Bresch, filedby Mylan Inc. as Exhibit 10.27(b) to Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.*10.9(a) Transition and Succession Agreement, dated January 31, 2007, between Mylan Inc. and Rajiv Malik, filed by Mylan Inc. as Exhibit10.5 to Form 10-Q for the quarter ended March 31, 2008, and incorporated herein by reference.*10.9(b) Amendment No. 1 to Transition and Succession Agreement, dated December 22, 2008, between Mylan Inc. and Rajiv Malik, filed byMylan Inc. as Exhibit 10.28(b) to Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.*163Table of Contents10.10(a) Transition and Succession Agreement, dated February 25, 2008, by and between Mylan Inc. and Anthony Mauro, filed by Mylan Inc.as Exhibit 10.5(a) to Form 10-Q for the quarter ended March 31, 2012, and incorporated herein by reference.*10.10(b) Amendment No. 1 to Transition and Succession Agreement, dated December 15, 2008, by and between Mylan Inc. and AnthonyMauro, filed by Mylan Inc. as Exhibit 10.5(b) to Form 10-Q for the quarter ended March 31, 2012, and incorporated herein byreference.*10.10(c) Amendment No. 2 to Transition and Succession Agreement, dated October 15, 2009, by and between Mylan Inc. and Anthony Mauro,filed by Mylan Inc. as Exhibit 10.5(c) to Form 10-Q for the quarter ended March 31, 2012, and incorporated herein by reference.*10.11 Form of Transition and Succession Agreement Waiver Letter by and between Mylan Inc. and certain executive officers of Mylan Inc.,filed by Mylan Inc. as Exhibit 10.57 to Form 10-K for the fiscal year ended December 31, 2014, and incorporated herein by reference.*10.12 Transition and Succession Agreement, dated April 27, 2016 and effective June 6, 2016, between Mylan Inc. and Kenneth S. Parks, filedas Exhibit 10.3 to Form 10-Q for the quarter ended June 30, 2016, and incorporated herein by reference.*10.13 Transition and Succession Agreement, dated March 24, 2017, between Mylan Inc. and Daniel M. Gallagher, filed as Exhibit 10.6 toForm 10-Q for the quarter ended March 31, 2017, and incorporated herein by reference. *10.14(a) Mylan 401(k) Restoration Plan, dated January 1, 2010, filed by Mylan Inc. as Exhibit 10.1 to the Report on Form 8-K filed by MylanInc. with the SEC on December 14, 2009, and incorporated herein by reference.*10.14(b) Amendment to Mylan 401(k) Restoration Plan, dated November 4, 2014, filed by Mylan Inc. as Exhibit 10.41(b) to Form 10-K for thefiscal year ended December 31, 2014, and incorporated herein by reference.*10.15(a) Mylan Executive Income Deferral Plan, filed by Mylan Inc. as Exhibit 10.2 to the Report on Form 8-K filed with the SEC on December14, 2009, and incorporated herein by reference.*10.15(b) Amendment to Mylan Executive Income Deferral Plan, dated November 4, 2014, filed by Mylan Inc. as Exhibit 10.42(b) to Form 10-Kfor the fiscal year ended December 31, 2014, and incorporated herein by reference.*10.16 The Executive Nonqualified Excess Plan Adoption Agreement, effective as of December 28, 2007, between Mylan InternationalHoldings, Inc. and Rajiv Malik, filed by Mylan Inc. as Exhibit 10.27(b) to Form 10-K for the fiscal year ended December 31, 2013, andincorporated herein by reference.*10.17 The Executive Nonqualified Excess Plan, effective as of December 28, 2007, between Mylan International Holdings, Inc. and RajivMalik, filed by Mylan Inc. as Exhibit 10.57 to Form 10-K for the fiscal year ended December 31, 2013, and incorporated herein byreference.*10.18 Third Amended and Restated Executive Employment Agreement, entered into on February 25, 2014, by and between Mylan Inc. andRobert J. Coury, filed by Mylan Inc. as Exhibit 10.1 to the Report on Form 8-K filed with the SEC on February 28, 2014, andincorporated herein by reference.*10.19(a) Second Amended and Restated Executive Employment Agreement, entered into on February 25, 2014, by and between Mylan Inc. andHeather Bresch, filed by Mylan Inc. as Exhibit 10.3 to the Report on Form 8-K filed with the SEC on February 28, 2014, andincorporated herein by reference.*10.19(b) Extension No. 1, dated November 3, 2018 to the Second Amended and Restated Executive Employment Agreement, entered into onFebruary 25, 2014, by and between Mylan Inc. and Heather Bresch.*10.19(c) Third Amended and Restated Executive Employment Agreement, entered into on February 25, 2019, and effective as of April 1, 2019,by and between Mylan Inc. and Heather Bresch.*10.20(a) Second Amended and Restated Executive Employment Agreement, entered into on February 25, 2014, by and between Mylan Inc. andRajiv Malik, filed by Mylan Inc. as Exhibit 10.4 to the Report on Form 8-K filed with the SEC on February 28, 2014, and incorporatedherein by reference.*164Table of Contents10.20(b) Extension No. 1, dated November 3, 2018 to the Second Amended and Restated Executive Employment Agreement, entered into onFebruary 25, 2014, by and between Mylan Inc. and Rajiv Malik.*10.20(c) Third Amended and Restated Executive Employment Agreement, entered into on February 25, 2019 2019, and effective as of April 1,2019, by and between Mylan Inc. and Rajiv Malik.*10.21(a) Amended and Restated Executive Employment Agreement, dated January 8, 2016 and effective January 1, 2016, by and betweenMylan Inc. and Anthony Mauro, filed as Exhibit 10.16 to Form 10-K for the fiscal year ended December 31, 2015, and incorporatedherein by reference.*10.21(b) Executive Employment Agreement, dated as of February 25, 2019, and effective as of April 1, 2019, by and between Mylan Inc. andAnthony Mauro.*10.22(a) Executive Employment Agreement, dated April 27, 2016 and effective June 6, 2016, between Mylan Inc. and Kenneth S. Parks, filed asExhibit 10.2 to Form 10-Q for the quarter ended June 30, 2016, and incorporated herein by reference.*10.22(b) Executive Employment Agreement, dated as of February 25, 2019, and effective as of April 1, 2019, by and between Mylan Inc. andKenneth S. Parks.*10.23(a) Executive Employment Agreement, dated March 24, 2017 and effective April 1, 2017, between Mylan Inc. and Daniel M. Gallagher,filed as Exhibit 10.5 to Form 10-Q for the quarter ended March 31, 2017, and incorporated herein by reference *10.23(b) Consulting Agreement, entered into on February 25, 2019, by and between Mylan Inc. and Daniel M. Gallagher.*10.24 Letter Agreement, entered into on November 4, 2014, by and between Mylan Inc. and Robert J. Coury, filed by Mylan Inc. as Exhibit10.59 to Form 10-K for the fiscal year ended December 31, 2014, and incorporated herein by reference.*10.25 Letter Agreement, dated June 3, 2016, among Mylan N.V., Mylan Inc., and Robert J. Coury, filed as Exhibit 10.5 to Form 10-Q for thequarter ended June 30, 2016, and incorporated herein by reference.*10.26(a) Form of Performance-Based Stock Appreciation Rights Award Agreement under the Mylan Inc. One-Time Special Five-YearPerformance-Based Realizable Value Incentive Program, filed by Mylan Inc. as Exhibit 10.5 to the Report on Form 8-K filed with theSEC on February 28, 2014, and incorporated herein by reference.*10.26(b) Form of Performance-Based Restricted Stock Unit Award Agreement under the Mylan Inc. One-Time Special Five-Year Performance-Based Realizable Value Incentive Program, filed by Mylan Inc. as Exhibit 10.6 to the Report on Form 8-K filed with the SEC onFebruary 28, 2014, and incorporated herein by reference.*10.27(a) Form of One-Time Special Five-Year Performance-Based Realizable Value Incentive Program Waiver Letter with respect to StockAppreciation Rights, by and between Mylan Inc. and certain executive officers of Mylan Inc., filed by Mylan Inc. as Exhibit 10.56(a)to Form 10-K for the fiscal year ended December 31, 2014, and incorporated herein by reference.*10.27(b) Form of One-Time Special Five-Year Performance-Based Realizable Value Incentive Program Waiver Letter with respect toPerformance Based Restricted Stock Units, by and between Mylan Inc. and certain employees of Mylan Inc., filed by Mylan Inc. asExhibit 10.56(b) to Form 10-K for the fiscal year ended December 31, 2014, and incorporated herein by reference.*10.27(c) Form of Performance-Based Restricted Stock Unit Award Agreement under the One-Time Special Five-Year Performance-BasedRealizable Value Incentive Program for Kenneth S. Parks, filed as Exhibit 10.66 to Form 10-K for the fiscal year ended December 31,2016, and incorporated herein by reference.*10.27(d) Form of Performance-Based Restricted Stock Unit Award Agreement under the One-Time Special Five-Year Performance-BasedRealizable Value Incentive Program for Daniel M. Gallagher, filed as Exhibit 10.7 to Form 10-Q for the quarter ended March 31, 2017,and incorporated herein by reference. *10.28 Form of Waiver Letter with respect to Specified Award Agreements by and between Mylan N.V. and Heather Bresch and Rajiv Malik,February 23, 2017, filed as Exhibit 10.4 to Form 10-Q for the quarter ended March 31, 2017, and incorporated herein by reference. *165Table of Contents10.29 Supplemental Health Insurance Program For Certain Officers of Mylan Inc., effective May 1, 2005.*10.30 Amended and Restated Form of Indemnification Agreement between Mylan Inc. and each Director, filed by Mylan Inc. as Exhibit10.38 to Form 10-K for the fiscal year ended December 31, 2013, and incorporated herein by reference.*10.31 Form of Indemnification Agreement between Mylan N.V. and each Director, filed as Exhibit 10.1 to the Report on Form 8-K filed withthe SEC on February 27, 2015, and incorporated herein by reference.*10.32 Call Option Agreement between Mylan N.V. and Stichting Preferred Shares Mylan, dated April 3, 2015, filed as Exhibit 10.1 to theReport on Form 8-K filed with the SEC on April 3, 2015, and incorporated herein by reference.10.33(a) Revolving Credit Agreement, dated November 22, 2016, among Mylan N.V., Mylan Inc., as a guarantor, the lenders and issuing banksparty thereto and Bank of America, N.A., as the administrative agent, filed as Exhibit 10.62 to Form 10-K for the fiscal year endedDecember 31, 2016, and incorporated herein by reference.10.33(b) Amendment, dated as of November 3, 2017, to the Revolving Credit Agreement dated as of November 22, 2016, among Mylan N.V.,certain affiliates and subsidiaries of Mylan N.V. from time to time party thereto as guarantors, each lender from time to time partythereto, each issuing bank from time to time party thereto and Bank of America, N.A., as administrative agent, filed as Exhibit 10.3 tothe Form 10-Q for the quarter ended September 30, 2017, and incorporated herein by reference.10.34(a) Revolving Credit Agreement, dated as of July 27, 2018, among Mylan Inc., as borrower, Mylan N.V., as a guarantor, the otherguarantors party thereto, certain lenders and issuing banks and Bank of America, N.A., as administrative agent, filed as Exhibit 10.1 tothe Report on Form 8-K filed with the SEC on July 30, 2018, and incorporated herein by reference.10.34(b) Amendment No. 1, dated February 22, 2019, to the Revolving Credit Agreement dated as of July 27, 2018, among Mylan Inc., asborrower, Mylan N.V., as a guarantor, the other guarantors party thereto, certain lenders and issuing banks and Bank of America, N.A.,as administrative agent.10.35(a) Term Credit Agreement, dated November 22, 2016, among Mylan N.V., Mylan Inc., as a guarantor, the lenders party thereto andGoldman Sachs Bank USA, as administrative agent, filed as Exhibit 10.63 to Form 10-K for the fiscal year ended December 31, 2016,and incorporated herein by reference.10.35(b) Amendment, dated as of November 3, 2017, to the Term Credit Agreement dated as of November 22, 2016, among Mylan N.V., certainaffiliates and subsidiaries of Mylan N.V. from time to time party thereto as guarantors, each lender from time to time party thereto andGoldman Sachs Bank USA, as administrative agent, filed as Exhibit 10.4 to the Form 10-Q for the quarter ended September 30, 2017,and incorporated herein by reference.10.35(c) Amendment No. 2, dated as of February 22, 2019, to the Term Credit Agreement dated as of November 22, 2016, among the Company,certain affiliates and subsidiaries of the Company from time to time party thereto as guarantors, each lender from time to time partythereto and Goldman Sachs Bank USA, as administrative agent.10.36 Guarantee Agreement, dated as of December 22, 2016, among Meda AB (publ), Mylan N.V. and AB Svensk Exportkredit (publ), filedas Exhibit 10.64 to Form 10-K for the fiscal year ended December 31, 2016, and incorporated herein by reference.10.37 Guarantee, dated December 20, 2016, by Mylan N.V. of Meda AB (publ)’s obligations under the 2013/2018 SEK 600,000,000 floatingrate notes and 2014/2019 SEK 750,000,000 floating rate notes issued by Meda AB (publ), filed as Exhibit 10.65 to Form 10-K for thefiscal year ended December 31, 2016, and incorporated herein by reference.10.38 Form of Dealer Agreement among Mylan N.V., Mylan Inc. and the Dealer thereto, filed as Exhibit 10.1 to the Report on Form 8-K filedwith the SEC on June 8, 2017, and incorporated herein by reference.10.39 Form of Dealer Agreement among Mylan N.V., Mylan Inc. and the Dealer thereto, filed as Exhibit 10.2 to the Report on Form 8-K filedwith the SEC on July 30, 2018, and incorporated herein by reference.166Table of Contents10.40 Settlement Agreement with the U.S. Department of Justice and two relators finalizing the Medicaid drug rebate settlement, datedAugust 16, 2017, filed as Exhibit 10.1 to the Report on Form 8-K filed with the SEC on August 21, 2017, and incorporated herein byreference.10.41 Corporate Integrity Agreement between the Office of Inspector General of the Department of Health and Human Services and MylanInc. and Mylan Specialty L.P., dated August 16, 2017, filed as Exhibit 10.2 to the Report on Form 8-K filed with the SEC on August21, 2017, and incorporated herein by reference.10.42 Registration Rights Agreement, dated as of April 9, 2018, among Mylan Inc., Mylan N.V., as guarantor, and Deutsche Bank SecuritiesInc., J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, as representatives of the initial purchasers of the Notes, filed asExhibit 10.1 to the Report on Form 8-K filed with the SEC on April 9, 2018, and incorporated herein by reference.21.1 Subsidiaries of the registrant.23 Consent of Independent Registered Public Accounting Firm.31.1 Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.31.2 Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.32 Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.101.INS XBRL Instance Document101.SCH XBRL Taxonomy Extension Schema101.CAL XBRL Taxonomy Extension Calculation Linkbase101.LAB XBRL Taxonomy Extension Label Linkbase101.PRE XBRL Taxonomy Extension Presentation Linkbase101.DEF XBRL Taxonomy Extension Definition Linkbase*Denotes management contract or compensatory plan or arrangement.^Exhibits and schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company will furnish a copy of any omitted exhibitsand schedules to the Securities and Exchange Commission upon request but may request confidential treatment for any exhibit or schedule sofurnished.167Table of ContentsSIGNATURESPursuant to the requirements of section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Form to be signed onits behalf by the undersigned, thereunto duly authorized on February 26, 2019. Mylan N.V. by /s/ HEATHER BRESCH Heather Bresch Chief Executive OfficerPursuant to the requirements of the Securities Exchange Act of 1934, this Form has been signed below by the following persons on behalf of theregistrant and in the capacities indicated as of February 26, 2019. Signature Title /s/ HEATHER BRESCH Chief Executive Officer and DirectorHeather Bresch (Principal Executive Officer) /s/ KENNETH S. PARKS Chief Financial OfficerKenneth S. Parks (Principal Financial Officer) /s/ PAUL B. CAMPBELL Senior Vice President and Chief Accounting OfficerPaul B. Campbell (Principal Accounting Officer) /s/ ROBERT J. COURY Chairman and DirectorRobert J. Coury /s/ ROBERT J. CINDRICH DirectorRobert J. Cindrich /s/ JOELLEN LYONS DILLON DirectorJoEllen Lyons Dillon /s/ NEIL DIMICK DirectorNeil Dimick /s/ MELINA HIGGINS DirectorMelina Higgins /s/ HARRY A. KORMAN DirectorHarry A. Korman /s/ RAJIV MALIK President and DirectorRajiv Malik /s/ MARK W. PARRISH DirectorMark W. Parrish /s/ RANDALL L. VANDERVEEN, PH.D. DirectorRandall L. Vanderveen, Ph.D. /s/ PAULINE VAN DER MEER MOHR DirectorPauline van der Meer Mohr /s/ SJOERD S. VOLLEBREGT DirectorSjoerd S. Vollebregt 168Exhibit 10.29Supplemental Health Insurance Program For Certain Officers of Mylan Laboratories Inc.As Amended and Restated Effective May 1, 2005Mylan Laboratories Inc. (the “Company”) adopted a “Supplemental Health Insurance Program for Certain Officers of MylanLaboratories Inc. (“Program”), effective for retirements occurring on and after December 15, 2001, to provide health coverage benefitsfor certain executive officers of the Company, their spouses and their eligible dependents (the “Health Coverage”). The Companyhereby amends and restates the Program in its entirety, effective as of May 1, 2005. This Program is intended to supplement theapplicable health plan of the Company or any successor thereto that provides coverage for employees (the “Health Plan”) and isintended to constitute an “employee welfare benefit plan,” as defined in the Employee Retirement Income Security Act of 1974, asamended. The benefits offered under this Program can be provided through either insurance contracts, self-insured arrangements or anycombination of insurance and self-insurance.1.Eligibility Requirements: Duration of Coverage.Individuals of the Company who are eligible to participate in this program are (i) the former officers of the Company who arelisted on Exhibit A to the Program (“Class A Participants”), (ii) the current officers of the Company listed on Exhibit B to the Program(“Class B Participants”) and (iii) the current officers of the Company listed on Exhibit C to the Program (“Class C Participants”, andtogether with the Class A Participants and Class B Participants, collectively, the “Eligible Participants”). Subject to Section 4, theBoard of Directors of the Company (the “Board”) may, in its sole discretion, amend Exhibit A, Exhibit B or Exhibit C to add orremove individuals listed on such exhibits. The Health Coverage under this Program shall continue (A) in the case of a Class AParticipant (including a Class B Participant who, following termination of employment, has qualified for Health Coverage and isdeemed to be a Class A Participant), until the latest of (i) such participant’s death, (ii) the death of the spouse of such participant, or(iii) the date on which such participant’s dependents are no longer eligible for coverage under the Health Plan and (B) in the case of aClass C Participant, until the termination of such Class C Participant’s employment with the Company, or such longer period as maybe provided in any individual contract between the Company and such Class C Participant. With respect to Class A Participants andClass B Participants, for purposes of this Program, “spouse” shall mean, except as otherwise provided in Exhibit A, the person who islegally married to such participant on the date such participant’s employment terminated; provided, however, that such person shallcease to be considered a spouse once such person is no longer married to such participant unless (i) the marriage ends due to the deathof the participant or (ii) pursuant to a decree of legal divorce or separation such person is entitled to continue to receive coveragehereunder. With respect to Class C Participants, for purposes of this Program spouse shall mean the person who is legally married tosuch participant on the date the relevant medical claim is incurred.2.Health Coverage Provided.Subject to the payment of a premium by the Eligible Participant, such premium to be in an amount set forth next to the name ofsuch Eligible Participant in the applicable Exhibit, the Company shall provide the following coverage:(a)Class A Participants. With respect to a Class A Participant, the Company shall allow such participant to continue toparticipate in the Health Plan (including such portions of the Health Plan which provide for vision and prescription drugcoverage) pursuant to the terms of the Health Plan as in effect immediately prior to such participant’s retirement (including,without limitation, the lifetime maximums set forth in the Health Plan) until such participant is eligible for Medicarecoverage except that the Company shall pay all deductibles and co-payments that would have otherwise been payable bythe Class A Participant with respect to benefits provided to the Class A Participant (as well as such participant’s spouse anddependents) pursuant to the terms of the Health Plan. Upon the Class A Participant becoming eligible to receive MedicareCoverage, such Class A Participant shall elect a Medicare plan that includes prescription drug coverage (the “MedicarePlan”). With respect to any medical claim submitted by such participant which would have been covered in whole or in partby the Health Plan’s schedule of benefits and which is not fully covered by the Medicare Plan, the Company shall beresponsible solely for the difference, if any, between the actual costs of such claim and the portion of such costs covered bythe Medicare Plan. The Company shall continue to allow (i) such Class A Participant’s spouse to continue to participate inthe Health Plan until such time as such spouse becomes eligible to receive Medicare benefits and (ii) such Class AParticipant’s dependents to participate in the Health Plan until such time as such dependent would otherwise cease toreceive benefits under the Health Plan, or if earlier, until such time as such dependent becomes eligible to receive Medicarebenefits.(b)Class B Participants. With respect to a Class B Participant, the Company shall allow such participant to continue toparticipate in the Health Plan (including such portions of the Health Plan which provide for vision coverage) until such timeas such participant incurs a termination of employment. The rights of a Class B Participant to Health Coverage under thisProgram following a termination of employment shall be as follows:(i)Termination of Employment Prior to a Change in Control. Upon a termination of employment prior to a Changein Control (as defined in the Mylan Laboratories Inc. Severance Plan), the Class B Participant shall be deemedto be a Class A Participant and, along with such participant’s eligible spouse and dependents, shall be providedwith the Health Coverage described in paragraph (a) above, but only if (A) such participant’s employmentterminated for any reason other than by the Company for Cause (as defined below) and (B) at the time of suchtermination of employment, such participant had attained age 55 with 15 or more years of service with theCompany (without regard to any additional years of age or service credited to such participant pursuant to anyemployment or other agreement between the Company and the participant).(ii)Termination of Employment Following a Change in Control. Upon a termination of employment following aChange in Control, the Class B Participant shall be deemed to be a Class A Participant and, along with suchparticipant’s eligible spouse and dependents, shall be provided with the Health Coverage described inparagraph (a) above, but only if (A) such participant’s employment terminated for any reason other than by theCompany for Cause (as defined below) and (B) at the time of such termination of employment, such participanthad attained age 50 with 10 or more years of service with the Company (without regard to any additional yearsof age or service credited to such participant pursuant to any employment or other agreement between theCompany and the participant).(iii)Definition of Cause. For purposes of the Program, “Cause” shall mean (x) the willful and continued failure bythe Class B Participant to substantially perform such participant’s duties (other than any such failure resultingfrom such participant’s duties (other than any such failure resulting from such participant’s incapacity due to aphysical or mental illness) or (y) the willful engaging by the Class B Participant in conduct which is materiallyand demonstrably injurious to the Company, monetarily or otherwise. For purposes of clauses (x) and (y) above,no act, or failure to act, on the Class B Participant’s part shall be deemed “willful” unless done, or omitted to bedone, by the Class B Participant in bad faith or without reasonable belief that such act, or failure to act, was inthe best interests of the Company.(iv)Restrictions on Benefits. Notwithstanding anything to the contrary contained herein, the Company’s obligationto provide benefits under this Program to or in respect of Class B Participants upon a qualifying termination ofemployment shall be secondary to Medicare or any health benefits to which such participant (or, if applicable,such participant’s spouse and/or dependents) is eligible to obtain through Medicare, another employer orotherwise in connection with rendering services for a third party.(c)Class C Participants. The Company Class C Participant (along with such participant’s spouse and dependents) shall beeligible to participate in the Health Plan (including such portions of the Health Plan which provides for vision coverage)pursuant to the terms of the Health Plan as in effect from time to time (including, without limitation, the lifetimemaximums set forth in the Health Plan) until such time as such participant incurs a termination of employment (or suchlonger period as may be provided in any individual employment contract), except that the Company shall pay alldeductibles and co-payments that would be payable by the Class C Participant with respect to benefits provided to theClass C Participant (as well as such participant’s spouse and dependents) pursuant to the terms of the Health Plan. TheClass C Participant shall continue to pay all costs associated with the premiums set forth on Exhibit C. Notwithstandinganything to the contrary contained herein, the Company’s obligation to pay deductibles and co-payments in respect ofClass C Participants shall be secondary to any health benefits to which such participant’s spouse and/or dependents areeligible to obtain through another employer or otherwise in connection with rendering services for a third party.3. Enforcement. Any and all actions regarding the interpretation or application of any term or provision set forth herein shall begoverned by and interpreted in accordance with the substantive laws, and not the law of conflicts, of the Commonwealth ofPennsylvania to the extent not preempted by federal law, which shall otherwise control. The Company and each Eligible Participanteach do hereby respectively consent and agree that the courts of the Commonwealth of Pennsylvania shall have jurisdiction withrespect to any and all actions brought hereunder that are not preempted by federal law, and venue shall properly lie within theCommonwealth of Pennsylvania. The Company agrees to pay as incurred (within 10 days following the Company’s receipt of aninvoice from an Eligible Participant), to the full extent permitted by law, all legal fees and expenses that the Eligible Participant mayreasonably incur as a result of any contest or disagreement (regardless of the outcome thereof) by the Company, the Eligible Participantor others of the validity or enforceability of, or liability under, any provision of this Program or any guarantee of performance thereof(including as a result of any contest by the Eligible Participant about the coverage of benefits pursuant to this Program), plus, in eachcase, interest on any delayed payment at the applicable federal rate provided for in Section 7872(f)(2)(A) of the Internal Revenue Codeof 1986, as amended. No obligation of the Company under this Program to pay the Eligible Participant’s fees or expenses shall in anymanner confer upon the Company any right to select or approve any of the attorneys or accountants engaged by an Eligible Participant.4. Amendment; Termination. The Program may be amended or terminated by the Board at any time; provided, however, that, if suchamendment or termination would in any manner be adverse to the interests of (i) a Class A Participant or the spouse or dependentsthereof or (ii) a Class B Participant who, as of the date of such amendment or termination, had attained age 55 with 15 or more years ofservice (or, in the case of an amendment or termination following a Change in Control, who, as of the date of such amendment ortermination, had attained age 50 with 10 or more years of service) or the spouse or dependents thereof, the Program may not beamended or terminated without consent of such affected participants (or, in the event the applicable participant is no longer living,without consent of the spouse and dependents of such participant). In addition, following a Change in Control, the Program may not beamended or terminated in any manner that would adversely affect the coverage to be provided under this Program to any Class CParticipant who, at the time of such Change in Control, has attained age 50 with 10 or more years of service (or the spouse ordependents thereof), without the consent of such participant. Applicable age and service requirements set forth in this Section shall bedetermined without regard to any additional years of age or service credited to an Eligible Participant pursuant to any employment orother agreement between the Company and such participant. For the avoidance of doubt, an amendment to any exhibit hereto(including but not limited to any amendment to add or remove individuals listed on such exhibit) shall be treated as an amendment tothe Program.5. Plan Administrator. The Program shall be administered by the Board (the “Plan Administrator”). The Plan Administrator shalladminister the Program and may interpret the Program, prescribe, amend and rescind rules and regulations under the Program andmake all other determinations necessary or advisable for the administration of the Program, subject to all of the provisions of theProgram. The Plan Administrator may delegate any of its duties hereunder to such person or persons from time to time as it maydesignate. The Plan Administrator is empowered, on behalf of the Program, to engage accountants, legal counsel and such otherpersonnel as it deems necessary or advisable to assist it in the performance of its duties under the Program. The functions of any suchpersons engaged by the Plan Administrator shall be limited to the specified services and duties for which they are engaged, and suchpersons shall have no other duties, obligations or responsibilities under the Program. Such persons shall exercise no discretionaryauthority or discretionary control respecting the management of the Program. All reasonable expenses thereof shall be borne by theCompany.6. Successors. In addition to any obligations imposed by law upon any successor to the Company, the Company will require anysuccessor (whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or substantially all of the business and/orassets of the Company to expressly assume and agree to perform this Program in the same manner and to the same extent that theCompany would be required to perform it if no such succession had taken place.1Exhibit 10.19(b)November 3, 2018Reference is made to the Second Amended and Restated Executive Employment Agreement, entered into on February25, 2014 and effective as of January 1, 2014 (the “Agreement”), by and between you and Mylan Inc. The parties hereto acknowledgeand agree that the Term of Employment as set forth in Section 2 of the Agreement shall be extended to April 1, 2019. All otherprovisions of the Agreement, as modified by the foregoing, shall remain in full force and effect.MYLAN INC.by /s/ JoEllen Lyons Dillon Name: JoEllen Lyons Dillon Title: Authorized Signatory /s/ Heather Bresch Heather BreschExhibit 10.19(c)EXECUTION VERSIONThis Third Amended and Restated Executive Employment Agreement (the “Agreement”) is entered intoon February 25, 2019, to be effective as of April 1, 2019 (the “Effective Date”), by and between Mylan Inc.(the “Company” or “Mylan”) and Heather Bresch (“Executive”).RECITALS:WHEREAS, the Company and Executive are parties to a certain Executive Employment Agreement dated as ofFebruary 25, 2014, effective as of January 1, 2014, and an extension letter thereto governing the terms of Executive’s employmentwith the Company (the “Prior Agreement”); andWHEREAS, the Company wishes to retain Executive as Chief Executive Officer of Mylan N.V. beyond the term ofthe Prior Agreement, and accordingly the parties wish to amend and restate the Prior Agreement effective as of the Effective Date.NOW, THEREFORE, in consideration of the promises and mutual obligations of the parties contained herein, and forother valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and Executive agree asfollows:1.Employment of Executive; Position and Duties. Executive shall continue to be employed by the Company as ChiefExecutive Officer of Mylan N.V., on the terms and conditions provided herein. In the role of Chief Executive Officer, Executive shallhave the duties, roles and responsibilities traditionally assigned to the chief executive officer of a public company (except to the extentany such duties have been assigned to the Chairman of Mylan N.V.) and shall report to the Board of Directors of Mylan N.V. (the“Board of Directors”). Executive’s principal office shall be in the Pittsburgh metropolitan area; provided Executive shall travel inconnection with her employment, commensurate with the activities of her position. Executive agrees to devote her full business timeand attention to her duties.2. Effective Date: Term of Employment. This Agreement shall commence and be effective (and, except as provided herein,the Prior Agreement shall cease to be effective) as of the Effective Date, and shall terminate at the close of business on the fifthanniversary of the Effective Date, unless earlier terminated in accordance with the terms of this Agreement. Thereafter, this Agreementshall automatically renew for one (1) year periods (each period referred to as a “Renewal Term”) unless this Agreement is terminatedin accordance with the terms of this Agreement. The period during which this Agreement is effective being referred to as the “Term ofEmployment”.23. Executive’s Compensation. Executive’s compensation shall include the following:(a) Annual Base Salary. Executive’s annual base salary shall be equal to $1,500,000, which shall be retroactive toJanuary 1, 2019, payable in accordance with the Company’s normal payroll practices for its executive officers. The annual basesalary may be increased from time to time at the discretion of the Compensation Committee of the Board of Directors or anyother committee authorized by the Board of Directors. The annual base salary may not be decreased except where otherexecutive officers of the Company are required to accept a similar reduction. The annual base salary as in effect from time totime shall be referred to as the “Annual Base Salary”.(b) Annual Bonus. Executive shall be eligible to participate in the annual executive incentive or bonus plan as in effectfrom time to time, with the opportunity to receive an annual award in respect of each fiscal year of Mylan N.V. ending duringthe Term of Employment in accordance with the terms and conditions of such plan, with a target bonus opportunity equal to150% of Annual Base Salary. Such bonus shall be paid no later than March 15th of the year following the year in which theannual award is no longer subject to a substantial risk of forfeiture.(c) Fringe Benefits and Expense Reimbursement. Executive shall receive benefits and perquisites of employmentsimilar to those as have been customarily provided to Mylan N.V.’s most senior executive officers, including but not limited to,health insurance coverage, short-term disability benefits and twenty-five (25) vacation days, in each case in accordance with theplan documents or policies that govern such benefits. The Company shall reimburse Executive for all ordinary and necessarybusiness expenses in accordance with established Company policy and procedures.4. Confidentiality. Executive recognizes and acknowledges that the business interests of the Company and its subsidiaries,parents and affiliates (collectively, the “Mylan Companies”) require a confidential relationship between the Company and Executiveand the fullest protection and confidential treatment of the financial data, customer information, supplier information, marketinformation, marketing and/or promotional techniques and methods, pricing information, purchase information, sales policies,employee lists, policy and procedure information, records, advertising information, computer records, trade secrets, know how, plansand programs, sources of supply and other knowledge of the business of the Mylan Companies (all of which are hereinafter jointlytermed “Confidential Information”) which have or may in whole or in part be conceived, learned or obtained by Executive in thecourse of Executive’s employment with the Company. Accordingly, Executive agrees to keep secret and treat as confidential allConfidential Information whether or not copyrightable or patentable, and agrees not to use or aid others in learning of or using anyConfidential Information3except in the ordinary course of business and in furtherance of the Company’s interests. During the term of this Agreement and at alltimes thereafter, except insofar as is necessary disclosure consistent with the Company’s business interests:(a) Executive will not, directly or indirectly, disclose any Confidential Information to anyone outside the MylanCompanies;(b) Executive will not make copies of or otherwise disclose the contents of documents containing or constitutingConfidential Information;(c) As to documents which are delivered to Executive or which are made available to her as a necessary part of theworking relationships and duties of Executive within the business of the Company, Executive will treat such documentsconfidentially and will treat such documents as proprietary and confidential, not to be reproduced, disclosed or used withoutappropriate authority of the Company;(d) Executive will not advise others that the information and/or know how included in Confidential Information isknown to or used by the Company; and(e) Executive will not in any manner disclose or use Confidential Information for Executive’s own account and willnot aid, assist or abet others in the use of Confidential Information for their account or benefit, or for the account or benefit ofany person or entity other than the Company.The obligations set forth in this paragraph are in addition to any other agreements Executive may have with the Company andany and all rights the Company may have under state or federal statutes or common law.Nothing in or about this Agreement prohibits Executive from: (i) filing and, as provided for under Section 21F of the SecuritiesExchange Act of 1934, maintaining the confidentiality of a claim with the Securities and Exchange Commission (the “SEC”); (ii)providing Confidential Information (as defined herein) to the SEC, or providing the SEC with information that would otherwise violateSection 4, to the extent permitted by Section 21F of the Securities Exchange Act of 1934; (iii) cooperating, participating or assisting inan SEC investigation or proceeding without notifying the Company; or (iv) receiving a monetary award as set forth in Section 21F ofthe Securities Exchange Act of 1934.Furthermore, Executive is advised that Executive shall not be held criminally or civilly liable under any federal or state tradesecret law for the disclosure of any Confidential Information (as defined herein) that constitutes a trade secret to which the DefendTrade Secrets Act (18 U.S.C. Section 1833(b)) applies that is made (i) in confidence to a federal, state or local government official,either directly or indirectly, or to an attorney, in each case, solely for the purpose of reporting or investigating a4suspected violation of law or (ii) in a complaint or other document filed in a lawsuit or proceeding, if such filings are made under seal.5. Non-Competition and Non-Solicitation. Executive agrees that during the Term of Employment and for a period ending one(1) year after termination of Executive’s employment with the Company for any reason:(a) Executive shall not, directly or indirectly, whether for herself or for any other person, company, corporation orother entity be or become associated in any way (including but not limited to the association set forth in (i)-(vii) of thissubsection) with any business or organization which is directly or indirectly engaged in the research, development,manufacture, production, marketing, promotion or sale of any product the same as or similar to those of the Mylan Companies,or which competes or intends to compete in any line of business with the Mylan Companies. Notwithstanding the foregoing,Executive may during the period in which this paragraph is in effect own stock or other interests in corporations or otherentities that engage in businesses the same or substantially similar to those engaged in by the Mylan Companies; provided thatExecutive does not, directly or indirectly (including without limitation as the result of ownership or control of anothercorporation or other entity), individually or as part of a group (as that term is defined in Section 13(d) of the SecuritiesExchange Act of 1934, as amended, and the rules and regulations promulgated thereunder) (i) control or have the ability tocontrol the corporation or other entity; (ii) provide to the corporation or entity, whether as an executive, consultant or otherwise,advice or consultation; (iii) provide to the corporation or entity any confidential or proprietary information regarding the MylanCompanies or its businesses or regarding the conduct of businesses similar to those of the Mylan Companies; (iv) hold or havethe right by contract or arrangement or understanding with other parties to hold a position on the board of directors or othergoverning body of the corporation or entity or have the right by contract or arrangement or understanding with other parties toelect one or more persons to any such position; (v) hold a position as an officer of the corporation or entity; (vi) have thepurpose to change or influence the control of the corporation or entity (other than solely by the voting of her shares orownership interest); or (vii) have a business or other relationship, by contract or otherwise, with the corporation or entity otherthan as a passive investor in it; provided, however, that Executive may vote her shares or ownership interest in such manner asshe chooses provided that such action does not otherwise violate the prohibitions set forth in this sentence.(b) Executive will not, either directly or indirectly, either for herself or for any other person, partnership, firm,company, corporation or other entity, contact, solicit, divert or take away any of the customers or suppliers of the MylanCompanies.5(c) Executive will not solicit, entice or otherwise induce any employee of the Mylan Companies to leave the employ ofthe Mylan Companies for any reason whatsoever; nor will Executive directly or indirectly aid, assist or abet any other person orentity in soliciting or hiring any employee of the Mylan Companies, nor will Executive otherwise interfere with any contractualor other business relationships between the Mylan Companies and its employees.6. Severability. Should a court of competent jurisdiction determine that any section or sub-section of this Agreement isunenforceable because one or all of them are vague or overly broad, the parties agree that this Agreement may and shall be enforced tothe maximum extent permitted by law. It is the intent of the parties that each section and sub-section of this Agreement be a separateand distinct promise and that unenforceability of any one subsection shall have no effect on the enforceability of another.7. Injunctive Relief. The parties agree that in the event of Executive’s violation of Sections 4 and/or 5 of this Agreement orany subsection thereunder, that the damage to the Company will be irreparable and that money damages will be difficult or impossibleto ascertain. Accordingly, in addition to whatever other remedies the Company may have at law or in equity, Executive recognizes andagrees that the Company shall be entitled to a temporary restraining order and a temporary and permanent injunction enjoining andprohibiting any acts not permissible pursuant to this Agreement. Executive agrees that should either party seek to enforce or determineits rights because of an act of Executive which the Company believes to be in contravention of Sections 4 and/or 5 of this Agreementor any subsection thereunder, the duration of the restrictions imposed thereby shall be extended for a time period equal to the periodnecessary to obtain judicial enforcement of the Company’s rights.8. Termination of Employment.(a) Resignation. Executive may resign from employment at any time upon 90 days written notice to the Board ofDirectors. During the 90-day notice period Executive will continue to perform duties and abide by all other terms andconditions of this Agreement. Additionally, Executive will use her best efforts to effect a smooth and effective transition towhoever will replace Executive. The Company reserves the right to accelerate the effective date of Executive’s resignation;provided that Executive shall receive Executive’s salary and benefits through the 90-day period. If Executive resigns during theTerm of Employment without “Good Reason” (as defined below), the Company shall have no liability to Executive under thisAgreement other than that the Company shall pay Executive’s wages and benefits through the effective date of Executive’sresignation. Executive, however, will continue to be bound by all provisions of this Agreement that survive termination ofemployment. For purposes of this Agreement “Good Reason” shall mean: (i) a reduction of Executive’s Annual Base Salary asin effect from time to time, unless other executive officers of the Company are required to accept a similar reduction; (ii) theassignment of duties6to Executive which are inconsistent with those of a chief executive officer (including status, offices, titles and reportingrequirements); provided that Executive shall not have Good Reason to terminate her employment by reason of certain dutiesbeing assigned by the Board of Directors by resolution to the Chairman of Mylan N.V. as of the date hereof rather thanExecutive; (iii) removal from the position of Chief Executive Officer of Mylan N.V.; or (iv) the Company’s requiringExecutive to be based at any office or location other than in the Pittsburgh metropolitan area.(b) Termination for Cause. If the Company determines to terminate Executive’s employment during the Term ofEmployment for Cause, as defined herein, the Company shall have no liability to Executive other than to pay Executive’swages and benefits through the effective date of Executive’s termination. Executive, however, will continue to be bound by allprovisions of this Agreement that survive termination of employment. For purposes of this Agreement, “Cause” shall mean: (i)Executive’s willful and continued gross neglect of duties; (ii) the willful engaging by Executive in illegal conduct that ismaterially and demonstrably injurious to the Company; or (iii) the willful engaging by Executive in gross misconduct that ismaterially and demonstrably injurious to the Company, which, in the case of clauses (i) and (iii), has not been cured within 30days after a written demand for substantial performance is delivered to Executive by the Board of Directors that specificallyidentifies the manner in which the Board of Directors believes that Executive has grossly neglected her duties or has engaged ingross misconduct. No act, or failure to act, on the part of Executive shall be considered “willful” unless it is done, or omitted tobe done, by Executive in bad faith or without reasonable belief that Executive’s action or omission was in the best interests ofthe Company. Any act, or failure to act, based upon authority given pursuant to a resolution duly adopted by the Board ofDirectors or based upon the advice of counsel for the Company shall be conclusively presumed to be done, or omitted to bedone, by Executive in good faith and in the best interests of the Company. The cessation of employment of Executive shall notbe deemed to be for Cause unless and until there shall have been delivered to Executive a copy of a resolution duly adopted bythe affirmative vote of not less than three-quarters of the entire membership of the Board of Directors (excluding Executive, ifExecutive is a member of the Board of Directors) at a meeting of the Board called and held for such purpose (after reasonablenotice is provided to Executive and Executive is given an opportunity, together with counsel for Executive, to be heard beforethe Board of Directors), finding that, in the good faith opinion of the Board of Directors, Cause exists and specifying theparticulars thereof in detail.(c) Termination Without Cause or Resignation for Good Reason. If the Company discharges Executive without Causeor if Executive resigns from employment for Good Reason, then, in consideration, inter alia, for the restrictions contained inSections 4 and 5, the Company will pay Executive a7lump sum amount equal to two (2) times Annual Base Salary as in effect immediately prior to termination of employment(without regard to any reduction thereto constituting “Good Reason”). Subject to Section 8(h), such payment will be madewithin 30 days following Executive’s termination of employment. In addition, if the Company discharges Executive withoutCause or if Executive resigns from employment for Good Reason, the Company will (i) provide to Executive a prorated annualbonus for the fiscal year in which Executive’s termination occurs (the “Pro Rata Bonus”), such Pro Rata Bonus to bedetermined by reference to the bonus that Executive would have earned based on actual performance for the relevant fiscal yearhad Executive’s employment not terminated, with the resulting amount pro-rated to reflect the number of days elapsed in thefiscal year, through and including the date on which Executive’s termination of employment occurs and (ii) for two (2) yearsfollowing Executive’s termination of employment, continue to provide to Executive and/or Executive’s dependents the healthinsurance benefits that were provided to them immediately prior to Executive’s termination of employment (taking into accountany required employee contributions, co-payments and similar costs imposed on Executive) (the “Continuation Benefits”);provided, however, that the Company’s obligation to provide the Continuation Benefits shall end at such time as Executiveobtains health insurance benefits through another employer or otherwise in connection with rendering services for a third party.The parties agree to cooperate such that the Continuation Benefits are, to the extent practicable, provided in a manner so as tominimize adverse tax consequences to the Company under Section 4980D of the Code. Executive will continue to be bound byall provisions of this Agreement that survive termination of employment. Annual Base Salary and Bonus increases made duringthe first quarter of a calendar year shall not be taken into account for purposes of Section 8 until April 1 of such calendar year.(d) Death or Incapacity. The employment of Executive shall automatically terminate upon Executive’s death or uponthe occurrence of a disability that renders Executive incapable of performing the essential functions of her position within themeaning of the Americans With Disabilities Act of 1990. For all purposes of this Agreement, any such termination shall betreated in the same manner as a termination without Cause, as described in Section 8(c) above, and Executive, or Executive’sestate, as applicable, shall receive all consideration, compensation and benefits that would be due and payable to Executive fora termination without Cause; provided, however, that such consideration, compensation and benefits shall be reduced by anydeath or disability benefits (as applicable) that Executive or her estate or beneficiaries (as applicable) are entitled to pursuant toplans or arrangements of the Company.(e) Extension or Renewal. If the Company elects not to renew this Agreement, it may provide notice of nonrenewal nolater than 30 days prior to the end of the then-current Term of Employment (including any Renewal Term), and Executive’semployment shall terminate as of the end of such Term of8Employment, and Executive will be entitled to solely the compensation and benefits under Section 8(c) of this Agreement as ifExecutive’s employment had been terminated without Cause for purposes of this Agreement. For the avoidance of doubt,Executive will continue to be bound by all provisions of this Agreement that survive termination of employment. Non-renewalby Executive shall be governed by the terms of Section 8(a).(f) Return of Company Property. Upon the termination of Executive’s employment for any reason, Executive shallimmediately return to the Company all records, memoranda, files, notes, papers, correspondence, reports, documents, books,diskettes, hard drives, electronic files, and all copies or abstracts thereof that Executive has concerning any or all of the MylanCompanies’ business. Executive shall also immediately return all keys, identification cards or badges and other companyproperty.(g) No Duty to Mitigate. There shall be no requirement on the part of Executive to seek other employment orotherwise mitigate damages in order to be entitled to the full amount of any payments and benefits to which Executive isotherwise entitled under any contract and, except as set forth herein with respect to the Continuation Benefits, the amount ofsuch payments and benefits shall not be reduced by any compensation or benefits received by Executive from otheremployment.(h) Conditions to Payment and Acceleration; Section 409A of the Code. The intent of the parties is that payments andbenefits under this Agreement comply with Section 409A of the Internal Revenue Code (the “Code”) to the extent subjectthereto, and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted and administered to be incompliance therewith. Notwithstanding anything contained herein to the contrary, to the extent required in order to avoidaccelerated taxation and/or tax penalties under Section 409A of the Code, Executive shall not be considered to have terminatedemployment with the Company for purposes of this Agreement and no payments shall be due to Executive under Section 8 ofthis Agreement until Executive would be considered to have incurred a “separation from service” from the Company within themeaning of Section 409A of the Code. For purposes of this Agreement, each amount to be paid or benefit to be provided shallbe construed as a separate identified payment for purposes of Section 409A of the Code, and any payments described inSection 8 that are due within the “short term deferral period” as defined in Section 409A of the Code shall not be treated asdeferred compensation unless applicable law requires otherwise. To the extent required in order to avoid accelerated taxationand/or tax penalties under Section 409A of the Code, amounts that would otherwise be payable and benefits that wouldotherwise be provided pursuant to this Agreement during the six-month period immediately following Executive’s terminationof employment shall instead be paid on the first business day after the date that is six months following Executive’s terminationof9employment (or death, if earlier). To the extent required to avoid an accelerated or additional tax under Section 409A of theCode, amounts reimbursable to Executive under this Agreement shall be paid to Executive on or before the last day of the yearfollowing the year in which the expense was incurred and the amount of expenses eligible for reimbursement (and in-kindbenefits provided to Executive) during any one year may not affect amounts reimbursable or provided in any subsequent year;provided, however, that with respect to any reimbursements for any taxes which Executive would become entitled to under theterms of the Agreement, the payment of such reimbursements shall be made by the Company no later than the end of thecalendar year following the calendar year in which Executive remits the related taxes. In order to receive any payments orbenefits under this Section 8, Executive shall be required to execute in advance the Company’s then-current customary generalrelease and waiver of any and all claims of any kind, known and unknown, against the Company, its current and formerparents, subsidiaries, affiliates, predecessors and successors, and their respective current and former officers, directors, agents,employees, investors, attorneys, shareholders, fiduciaries, benefit plans, plan administrators, insurers, trustees and all personsacting with or on behalf of any of them (the “Releasees”), arising out of or relating in any way to (i) Executive’s employmentwith any of the Mylan Companies; (ii) any acts or omissions of any of the Releasees during the course of Executive’semployment with any of the Mylan Companies; or (iii) the termination of Executive’s employment with any of the MylanCompanies, including but not limited to a release and waiver of any and all such claims of any kind arising under all federal,state or local statutes, other laws, regulations or the common law; provided, however, that the release and waiver of claims shallexclude claims relating to vested pension benefits, deferred compensation arrangements, workers’ compensation benefits,unemployment compensation benefits, claims that arise after the release and waiver is signed by Executive and claims thatcannot be released or waived under applicable law.9. Indemnification. The Company shall maintain D&O liability coverage pursuant to which Executive shall be a coveredinsured. Executive shall receive indemnification in accordance with the Company’s Bylaws in effect as of the date of this Agreement.Such indemnification shall be contractual in nature and shall remain in effect notwithstanding any future change to the Company’sBylaws.To the extent not otherwise limited by the Company’s Bylaws in effect as of the date of this Agreement, in the event thatExecutive is made a party or is threatened to be made a party to or is involved in any action, suit or proceeding, (including thosebrought by or in the right of the Company) whether civil, criminal, administrative or investigative (“proceeding”), by reason of the factthat she is or was an officer, employee or agent of or is or was serving the Company or any subsidiary of the Company, or is or wasserving at the request of the Company or another corporation, or of a partnership, joint venture, trust or other enterprise, includingservice with respect to employee benefit plans, whether the basis of such proceeding is alleged action in an official capacity as adirector, officer,10employee or agent or in any other capacity while serving as a director, officer, employee or agent, Executive shall be indemnified andheld harmless by the Company to the fullest extent authorized by law against all expenses, liabilities and losses (including attorneysfees, judgments, fines, ERISA excise taxes or penalties and amounts paid or to be paid in settlement) reasonably incurred or sufferedby Executive in connection therewith. Such right shall be a contract right and shall include the right to be paid by the Companyexpenses incurred in defending any such proceeding in advance of its final disposition; provided, however, that the payment of suchexpenses incurred by Executive in her capacity as a director or officer (and not in any other capacity in which service was or isrendered by Executive while a director or officer, including, without limitation, service to an employee benefit plan) in advance of thefinal disposition of such proceeding will be made only upon delivery to the Company of an undertaking, by or on behalf of Executive,to repay all amounts to the Company so advanced if it should be determined ultimately that Executive is not entitled to be indemnifiedunder this section or otherwise.Promptly after receipt by Executive of notice of the commencement of any action, suit or proceeding for which Executive maybe entitled to be indemnified, Executive shall notify the Company in writing of the commencement thereof (but the failure to notify theCompany shall not relieve it from any liability which it may have under this Section 9 unless and to the extent that it has beenprejudiced in a material respect by such failure or from the forfeiture of substantial rights and defenses). If any such action, suit orproceeding is brought against Executive and she notifies the Company of the commencement thereof, the Company will be entitled toparticipate therein, and, to the extent it may elect by written notice delivered to Executive promptly after receiving the aforesaid noticefrom Executive, to assume the defense thereof with counsel reasonably satisfactory to Executive, which may be the same counsel ascounsel to the Company. Notwithstanding the foregoing, Executive shall have the right to employ her own counsel in any such case,but the fees and expenses of such counsel shall be at the expense of Executive unless (i) the employment of such counsel shall havebeen authorized in writing by the Company, (ii) the Company shall not have employed counsel reasonably satisfactory to Executive totake charge of the defense of such action within a reasonable time after notice of commencement of the action or (iii) Executive shallhave reasonably concluded, after consultation with counsel to Executive, that a conflict of interest exists which makes representationby counsel chosen by the Company not advisable (in which case the Company shall not have the right to direct the defense of suchaction on behalf of Executive), in any of which events such fees and expenses of one additional counsel shall be borne by theCompany. Anything in this Section 9 to the contrary notwithstanding, the Company shall not be liable for any settlement of any claimor action effected without its written consent.10. Other Agreements. The rights and obligations contained in this Agreement are in addition to and not in place of any rightsor obligations contained in any other agreements between Executive and the Company.1111. Notices. All notices hereunder to the parties hereto shall be in writing sent by certified mail, return receipt requested,postage prepaid, and by fax, addressed to the respective parties at the following addresses:If to the Company: Mylan Inc.1000 Mylan Blvd.Canonsburg, Pennsylvania 15317Attn: Chief Legal OfficerFax: 724-514-1871If to Executive: at the most recent address on record at the Company.Either party may, by written notice complying with the requirements of this section, specify another or different person oraddress for the purpose of notification hereunder. All notices shall be deemed to have been given and received on the day a fax is sentor, if mailed only, on the third business day following such mailing.12. Withholding. All payments required to be made by the Company hereunder to Executive or her dependents, beneficiariesor estate will be subject to the withholding of such amounts relating to tax and/or other payroll deductions as may be required by law.13. Modification and Waiver. This Agreement may not be changed or terminated orally, nor shall any change, termination orattempted waiver of any of the provisions contained in this Agreement be binding unless in writing and signed by the party againstwhom the same is sought to be enforced, nor shall this section itself by waived verbally. This Agreement may be amended only by awritten instrument duly executed by or on behalf of the parties hereto.14. Construction of Agreement. This Agreement and all of its provisions were subject to negotiation and shall not beconstrued more strictly against one party than against another party regardless of which party drafted any particular provision.15. Successors and Assigns. This Agreement and all of its provisions, rights and obligations shall be binding upon and inureto the benefit of the parties hereto and the Company’s successors and assigns. This Agreement may be assigned by the Company toany person, firm or corporation which shall become the owner of substantially all of the assets of the Company or which shall succeedto the business of the Company; provided, however, that in the event of any such assignment the Company shall obtain an instrumentin writing from the assignee in which such assignee assumes the obligations of the Company hereunder and shall deliver an executedcopy thereof to Executive. No right or interest to or in any payments or benefits hereunder shall be assignable by Executive; provided,however, that this provision shall not preclude her from designating one or more beneficiaries to receive any amount that may bepayable after her death and shall not preclude the legal representative of her estate from assigning any right hereunder to the person orpersons entitled thereto under her will or, in the case of12intestacy, to the person or persons entitled thereto under the laws of intestacy applicable to her estate. The term “beneficiaries” as usedin this Agreement shall mean a beneficiary or beneficiary or beneficiaries so designated to receive any such amount, or if nobeneficiary has been so designated, the legal representative of Executive’s estate. No right, benefit or interest hereunder, shall besubject to anticipation, alienation, sale, assignment, encumbrance, charge, pledge, hypothecation or set-off in respect of any claim,debt, or obligation, or to execution, attachment, levy, or similar process, or assignment by operation of law. Any attempt, voluntary orinvoluntary, to effect any action specified in the immediately preceding sentence shall, to the full extent permitted by law, be null, voidand of no effect.16. Choice of Law and Forum. This Agreement shall be construed and enforced according to, and the rights and obligationsof the parties shall be governed in all respects by, the laws of the State of New York. Any controversy, dispute or claim arising out ofor relating to this Agreement, or the breach hereof, including a claim for injunctive relief, or any claim which, in any way arises out ofor relates to, Executive’s employment with the Company or the termination of said employment, including but not limited to statutoryclaims for discrimination, shall be resolved by arbitration in accordance with the then current rules of the American ArbitrationAssociation respecting employment disputes except that the parties shall be entitled to engage in all forms of discovery permitted underthe New York Civil Practice Law and Rules (as such rules may be in effect from time to time). The hearing of any such dispute will beheld in New York, New York, and the losing party shall bear the costs, expenses and counsel fees of such proceeding. Executive andCompany agree for themselves, their, employees, successors and assigns and their accountants, attorneys and experts that anyarbitration hereunder will be held in complete confidence and, without the other party’s prior written consent, will not be disclosed, inwhole or in part, to any other person or entity except as may be required by law. The decision of the arbitrator(s) will be final andbinding on all parties. Executive and the Company expressly consent to the jurisdiction of any such arbitrator over them.17. Headings. The headings of the sections of this Agreement have been inserted for convenience of reference only and shallin no way affect the interpretation of any of the terms or conditions of this Agreement.18. Execution in Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemedan original, but all of which together shall constitute one and the same instrument.[Signature page follows]IN WITNESS WHEREOF, the undersigned have executed this Agreement on the day and year first above mentioned.MYLAN INC.,by /s/ JoEllen Lyons Dillon Name: JoEllen Lyons Dillon Title: Chair, Compensation Committeeof Mylan N.V. /s/ Heather Bresch Heather BreschExhibit 10.20(b)November 3, 2018Reference is made to the Second Amended and Restated Executive Employment Agreement, entered into on February25, 2014 and effective as of January 1, 2014 (the “Agreement”), by and between you and Mylan Inc. The parties hereto acknowledgeand agree that the Term of Employment as set forth in Section 2 of the Agreement shall be extended to April 1, 2019. All otherprovisions of the Agreement, as modified by the foregoing, shall remain in full force and effect.MYLAN INC.by /s/ JoEllen Lyons Dillon Name: JoEllen Lyons Dillon Title: Authorized Signatory /s/ Rajiv Malik Name: Rajiv MalikExhibit 10.20(c)EXECUTION VERSIONThis Third Amended and Restated Executive Employment Agreement (the “Agreement”) is entered intoon February 25, 2019, to be effective as of April 1, 2019 (the “Effective Date”), by and between Mylan Inc.(the “Company” or “Mylan”) and Rajiv Malik (“Executive”).RECITALS:WHEREAS, the Company and Executive are parties to a certain Executive Employment Agreement dated as ofFebruary 25, 2014, effective as of January 1, 2014, and an extension letter thereto governing the terms of Executive’s employmentwith the Company (the “Prior Agreement”); andWHEREAS, the Company wishes to retain Executive as President of Mylan N.V. beyond the term of the PriorAgreement, and accordingly the parties wish to amend and restate the Prior Agreement effective as of the Effective Date.NOW, THEREFORE, in consideration of the promises and mutual obligations of the parties contained herein, and forother valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and Executive agree asfollows:1.Employment of Executive; Position and Duties. Executive shall continue to be employed by the Company asPresident of Mylan N.V., on the terms and conditions provided herein. In the role of President, Executive shall have the duties, rolesand responsibilities traditionally assigned to the president of a public company and shall report to the Chief Executive Officer of MylanN.V. Executive’s principal office shall be in the Pittsburgh metropolitan area; provided Executive shall travel in connection with hisemployment, commensurate with the activities of his position. Executive agrees to devote his full business time and attention to hisduties.2. Effective Date: Term of Employment. This Agreement shall commence and be effective (and, except as provided herein,the Prior Agreement shall cease to be effective) as of the Effective Date, and shall terminate at the close of business on the thirdanniversary of the Effective Date, unless earlier terminated in accordance with the terms of this Agreement. Thereafter, this Agreementshall automatically renew for one (1) year periods (each period referred to as a “Renewal Term”) unless this Agreement is terminatedin accordance with the terms of this Agreement. The period during which this Agreement is effective being referred to as the “Term ofEmployment”.3. Executive’s Compensation. Executive’s compensation shall include the following:2(a) Annual Base Salary. Executive’s annual base salary shall be equal to $1,150,000, which shall be retroactive toJanuary 1, 2019, payable in accordance with the Company’s normal payroll practices for its executive officers. The annual basesalary may be increased from time to time at the discretion of the Compensation Committee of the Board of Directors or anyother committee authorized by the Board of Directors. The annual base salary may not be decreased except where otherexecutive officers of the Company are required to accept a similar reduction. The annual base salary as in effect from time totime shall be referred to as the “Annual Base Salary”.(b) Annual Bonus. Executive shall be eligible to participate in the annual executive incentive or bonus plan as in effectfrom time to time, with the opportunity to receive an annual award in respect of each fiscal year of Mylan N.V. ending duringthe Term of Employment in accordance with the terms and conditions of such plan, with a target bonus opportunity equal to125% of Annual Base Salary. Such bonus shall be paid no later than March 15th of the year following the year in which theannual award is no longer subject to a substantial risk of forfeiture.(c) Fringe Benefits and Expense Reimbursement. Executive shall receive benefits and perquisites of employmentsimilar to those as have been customarily provided to Mylan N.V.’s most senior executive officers, including but not limited to,health insurance coverage, short-term disability benefits and twenty-five (25) vacation days, in each case in accordance with theplan documents or policies that govern such benefits. The Company shall reimburse Executive for all ordinary and necessarybusiness expenses in accordance with established Company policy and procedures.4. Confidentiality. Executive recognizes and acknowledges that the business interests of the Company and its subsidiaries,parents and affiliates (collectively, the “Mylan Companies”) require a confidential relationship between the Company and Executiveand the fullest protection and confidential treatment of the financial data, customer information, supplier information, marketinformation, marketing and/or promotional techniques and methods, pricing information, purchase information, sales policies,employee lists, policy and procedure information, records, advertising information, computer records, trade secrets, know how, plansand programs, sources of supply and other knowledge of the business of the Mylan Companies (all of which are hereinafter jointlytermed “Confidential Information”) which have or may in whole or in part be conceived, learned or obtained by Executive in thecourse of Executive’s employment with the Company. Accordingly, Executive agrees to keep secret and treat as confidential allConfidential Information whether or not copyrightable or patentable, and agrees not to use or aid others in learning of or using anyConfidential Information except in the ordinary course of business and in furtherance of the Company’s interests. During the term ofthis Agreement and at all times thereafter, except insofar as is necessary disclosure consistent with the Company’s business interests:3(a) Executive will not, directly or indirectly, disclose any Confidential Information to anyone outside the MylanCompanies;(b) Executive will not make copies of or otherwise disclose the contents of documents containing or constitutingConfidential Information;(c) As to documents which are delivered to Executive or which are made available to him as a necessary part of theworking relationships and duties of Executive within the business of the Company, Executive will treat such documentsconfidentially and will treat such documents as proprietary and confidential, not to be reproduced, disclosed or used withoutappropriate authority of the Company;(d) Executive will not advise others that the information and/or know how included in Confidential Information isknown to or used by the Company; and(e) Executive will not in any manner disclose or use Confidential Information for Executive’s own account and willnot aid, assist or abet others in the use of Confidential Information for their account or benefit, or for the account or benefit ofany person or entity other than the Company.The obligations set forth in this paragraph are in addition to any other agreements Executive may have with the Company andany and all rights the Company may have under state or federal statutes or common law.Nothing in or about this Agreement prohibits Executive from: (i) filing and, as provided for under Section 21F of the SecuritiesExchange Act of 1934, maintaining the confidentiality of a claim with the Securities and Exchange Commission (the “SEC”); (ii)providing Confidential Information (as defined herein) to the SEC, or providing the SEC with information that would otherwise violateSection 4, to the extent permitted by Section 21F of the Securities Exchange Act of 1934; (iii) cooperating, participating or assisting inan SEC investigation or proceeding without notifying the Company; or (iv) receiving a monetary award as set forth in Section 21F ofthe Securities Exchange Act of 1934.Furthermore, Executive is advised that Executive shall not be held criminally or civilly liable under any federal or state tradesecret law for the disclosure of any Confidential Information (as defined herein) that constitutes a trade secret to which the DefendTrade Secrets Act (18 U.S.C. Section 1833(b)) applies that is made (i) in confidence to a federal, state or local government official,either directly or indirectly, or to an attorney, in each case, solely for the purpose of reporting or investigating a suspected violation oflaw or (ii) in a complaint or other document filed in a lawsuit or proceeding, if such filings are made under seal.45. Non-Competition and Non-Solicitation. Executive agrees that during the Term of Employment and for a period ending one(1) year after termination of Executive’s employment with the Company for any reason:(a) Executive shall not, directly or indirectly, whether for himself or for any other person, company, corporation orother entity be or become associated in any way (including but not limited to the association set forth in (i)-(vii) of thissubsection) with any business or organization which is directly or indirectly engaged in the research, development,manufacture, production, marketing, promotion or sale of any product the same as or similar to those of the Mylan Companies,or which competes or intends to compete in any line of business with the Mylan Companies. Notwithstanding the foregoing,Executive may during the period in which this paragraph is in effect own stock or other interests in corporations or otherentities that engage in businesses the same or substantially similar to those engaged in by the Mylan Companies; provided thatExecutive does not, directly or indirectly (including without limitation as the result of ownership or control of anothercorporation or other entity), individually or as part of a group (as that term is defined in Section 13(d) of the SecuritiesExchange Act of 1934, as amended, and the rules and regulations promulgated thereunder) (i) control or have the ability tocontrol the corporation or other entity; (ii) provide to the corporation or entity, whether as an executive, consultant or otherwise,advice or consultation; (iii) provide to the corporation or entity any confidential or proprietary information regarding the MylanCompanies or its businesses or regarding the conduct of businesses similar to those of the Mylan Companies; (iv) hold or havethe right by contract or arrangement or understanding with other parties to hold a position on the board of directors or othergoverning body of the corporation or entity or have the right by contract or arrangement or understanding with other parties toelect one or more persons to any such position; (v) hold a position as an officer of the corporation or entity; (vi) have thepurpose to change or influence the control of the corporation or entity (other than solely by the voting of his shares orownership interest); or (vii) have a business or other relationship, by contract or otherwise, with the corporation or entity otherthan as a passive investor in it; provided, however, that Executive may vote his shares or ownership interest in such manner ashe chooses provided that such action does not otherwise violate the prohibitions set forth in this sentence.(b) Executive will not, either directly or indirectly, either for himself or for any other person, partnership, firm,company, corporation or other entity, contact, solicit, divert or take away any of the customers or suppliers of the MylanCompanies.(c) Executive will not solicit, entice or otherwise induce any employee of the Mylan Companies to leave the employ ofthe Mylan Companies for any reason whatsoever; nor will Executive directly or indirectly aid, assist or abet any5other person or entity in soliciting or hiring any employee of the Mylan Companies, nor will Executive otherwise interfere withany contractual or other business relationships between the Mylan Companies and its employees.6. Severability. Should a court of competent jurisdiction determine that any section or sub-section of this Agreement isunenforceable because one or all of them are vague or overly broad, the parties agree that this Agreement may and shall be enforced tothe maximum extent permitted by law. It is the intent of the parties that each section and sub-section of this Agreement be a separateand distinct promise and that unenforceability of any one subsection shall have no effect on the enforceability of another.7. Injunctive Relief. The parties agree that in the event of Executive’s violation of Sections 4 and/or 5 of this Agreement orany subsection thereunder, that the damage to the Company will be irreparable and that money damages will be difficult or impossibleto ascertain. Accordingly, in addition to whatever other remedies the Company may have at law or in equity, Executive recognizes andagrees that the Company shall be entitled to a temporary restraining order and a temporary and permanent injunction enjoining andprohibiting any acts not permissible pursuant to this Agreement. Executive agrees that should either party seek to enforce or determineits rights because of an act of Executive which the Company believes to be in contravention of Sections 4 and/or 5 of this Agreementor any subsection thereunder, the duration of the restrictions imposed thereby shall be extended for a time period equal to the periodnecessary to obtain judicial enforcement of the Company’s rights.8. Termination of Employment.(a) Resignation. Executive may resign from employment at any time upon 90 days written notice to the Board ofDirectors. During the 90-day notice period Executive will continue to perform duties and abide by all other terms andconditions of this Agreement. Additionally, Executive will use his best efforts to effect a smooth and effective transition towhoever will replace Executive. The Company reserves the right to accelerate the effective date of Executive’s resignation;provided that Executive shall receive Executive’s salary and benefits through the 90-day period. If Executive resigns during theTerm of Employment without “Good Reason” (as defined below), the Company shall have no liability to Executive under thisAgreement other than that the Company shall pay Executive’s wages and benefits through the effective date of Executive’sresignation. Executive, however, will continue to be bound by all provisions of this Agreement that survive termination ofemployment. For purposes of this Agreement “Good Reason” shall mean: (i) a reduction of Executive’s Annual Base Salary asin effect from time to time, unless other executive officers of the Company are required to accept a similar reduction; or (ii) theassignment of duties to Executive which are inconsistent with those of an executive officer.(b) Termination for Cause. If the Company determines to terminate Executive’s employment during the Term ofEmployment for Cause, as defined6herein, the Company shall have no liability to Executive other than to pay Executive’s wages and benefits through the effectivedate of Executive’s termination. Executive, however, will continue to be bound by all provisions of this Agreement that survivetermination of employment. For purposes of this Agreement, “Cause” shall mean: (i) Executive’s willful and continued grossneglect of duties; (ii) the willful engaging by Executive in illegal conduct that is materially and demonstrably injurious to theCompany; or (iii) the willful engaging by Executive in gross misconduct that is materially and demonstrably injurious to theCompany, which, in the case of clauses (i) and (iii), has not been cured within 30 days after a written demand for substantialperformance is delivered to Executive by the Board of Directors that specifically identifies the manner in which the Board ofDirectors believes that Executive has grossly neglected his duties or has engaged in gross misconduct. No act, or failure to act,on the part of Executive shall be considered “willful” unless it is done, or omitted to be done, by Executive in bad faith orwithout reasonable belief that Executive’s action or omission was in the best interests of the Company. Any act, or failure toact, based upon authority given pursuant to a resolution duly adopted by the Board of Directors or based upon the advice ofcounsel for the Company shall be conclusively presumed to be done, or omitted to be done, by Executive in good faith and inthe best interests of the Company. The cessation of employment of Executive shall not be deemed to be for Cause unless anduntil there shall have been delivered to Executive a copy of a resolution duly adopted by the affirmative vote of not less thanthree-quarters of the entire membership of the Board of Directors (excluding Executive, if Executive is a member of the Boardof Directors) at a meeting of the Board called and held for such purpose (after reasonable notice is provided to Executive andExecutive is given an opportunity, together with counsel for Executive, to be heard before the Board of Directors), finding that,in the good faith opinion of the Board of Directors, Cause exists and specifying the particulars thereof in detail.(c) Termination Without Cause or Resignation for Good Reason. If the Company discharges Executive without Causeor if Executive resigns from employment for Good Reason, then, in consideration, inter alia, for the restrictions contained inSections 4 and 5, the Company will pay Executive a lump sum amount equal to one and one-half (1.5) times Annual BaseSalary as in effect immediately prior to termination of employment (without regard to any reduction thereto constituting “GoodReason”). Subject to Section 8(h), such payment will be made within 30 days following Executive’s termination ofemployment. In addition, if the Company discharges Executive without Cause or if Executive resigns from employment forGood Reason, the Company will (i) provide to Executive a prorated annual bonus for the fiscal year in which Executive’stermination occurs (the “Pro Rata Bonus”), such Pro Rata Bonus to be determined by reference to the bonus that Executivewould have earned based on actual performance for the relevant fiscal year had Executive’s employment not terminated, withthe resulting amount pro-rated to reflect the number of days7elapsed in the fiscal year, through and including the date on which Executive’s termination of employment occurs and (ii) foreighteen (18) months following Executive’s termination of employment, continue to provide to Executive and/or Executive’sdependents the health insurance benefits that were provided to them immediately prior to Executive’s termination ofemployment (taking into account any required employee contributions, co-payments and similar costs imposed on Executive)(the “Continuation Benefits”); provided, however, that the Company’s obligation to provide the Continuation Benefits shallend at such time as Executive obtains health insurance benefits through another employer or otherwise in connection withrendering services for a third party. The parties agree to cooperate such that the Continuation Benefits are, to the extentpracticable, provided in a manner so as to minimize adverse tax consequences to the Company under Section 4980D of theCode. Executive will continue to be bound by all provisions of this Agreement that survive termination of employment. AnnualBase Salary and Bonus increases made during the first quarter of a calendar year shall not be taken into account for purposes ofSection 8 until April 1 of such calendar year.(d) Death or Incapacity. The employment of Executive shall automatically terminate upon Executive’s death or uponthe occurrence of a disability that renders Executive incapable of performing the essential functions of his position within themeaning of the Americans With Disabilities Act of 1990. For all purposes of this Agreement, any such termination shall betreated in the same manner as a termination without Cause, as described in Section 8(c) above, and Executive, or Executive’sestate, as applicable, shall receive all consideration, compensation and benefits that would be due and payable to Executive fora termination without Cause; provided, however, that such consideration, compensation and benefits shall be reduced by anydeath or disability benefits (as applicable) that Executive or his estate or beneficiaries (as applicable) are entitled to pursuant toplans or arrangements of the Company.(e) Extension or Renewal. If the Company elects not to renew this Agreement, it may provide notice of nonrenewal nolater than 30 days prior to the end of the then-current Term of Employment (including any Renewal Term), and Executive’semployment shall terminate as of the end of such Term of Employment, and Executive will be entitled to solely thecompensation and benefits under Section 8(c) of this Agreement as if Executive’s employment had been terminated withoutCause for purposes of this Agreement. For the avoidance of doubt, Executive will continue to be bound by all provisions ofthis Agreement that survive termination of employment. Non-renewal by Executive shall be governed by the terms of Section8(a).(f) Return of Company Property. Upon the termination of Executive’s employment for any reason, Executive shallimmediately return to the Company all records, memoranda, files, notes, papers, correspondence, reports, documents,8books, diskettes, hard drives, electronic files, and all copies or abstracts thereof that Executive has concerning any or all of theMylan Companies’ business. Executive shall also immediately return all keys, identification cards or badges and other companyproperty.(g) No Duty to Mitigate. There shall be no requirement on the part of Executive to seek other employment orotherwise mitigate damages in order to be entitled to the full amount of any payments and benefits to which Executive isotherwise entitled under any contract and, except as set forth herein with respect to the Continuation Benefits, the amount ofsuch payments and benefits shall not be reduced by any compensation or benefits received by Executive from otheremployment.(h) Conditions to Payment and Acceleration; Section 409A of the Code. The intent of the parties is that payments andbenefits under this Agreement comply with Section 409A of the Internal Revenue Code (the “Code”) to the extent subjectthereto, and, accordingly, to the maximum extent permitted, this Agreement shall be interpreted and administered to be incompliance therewith. Notwithstanding anything contained herein to the contrary, to the extent required in order to avoidaccelerated taxation and/or tax penalties under Section 409A of the Code, Executive shall not be considered to have terminatedemployment with the Company for purposes of this Agreement and no payments shall be due to Executive under Section 8 ofthis Agreement until Executive would be considered to have incurred a “separation from service” from the Company within themeaning of Section 409A of the Code. For purposes of this Agreement, each amount to be paid or benefit to be provided shallbe construed as a separate identified payment for purposes of Section 409A of the Code, and any payments described inSection 8 that are due within the “short term deferral period” as defined in Section 409A of the Code shall not be treated asdeferred compensation unless applicable law requires otherwise. To the extent required in order to avoid accelerated taxationand/or tax penalties under Section 409A of the Code, amounts that would otherwise be payable and benefits that wouldotherwise be provided pursuant to this Agreement during the six-month period immediately following Executive’s terminationof employment shall instead be paid on the first business day after the date that is six months following Executive’s terminationof employment (or death, if earlier). To the extent required to avoid an accelerated or additional tax under Section 409A of theCode, amounts reimbursable to Executive under this Agreement shall be paid to Executive on or before the last day of the yearfollowing the year in which the expense was incurred and the amount of expenses eligible for reimbursement (and in-kindbenefits provided to Executive) during any one year may not affect amounts reimbursable or provided in any subsequent year;provided, however, that with respect to any reimbursements for any taxes which Executive would become entitled to under theterms of the Agreement, the payment of such reimbursements shall be made by the Company no later than the end of thecalendar year following the calendar9year in which Executive remits the related taxes. In order to receive any payments or benefits under this Section 8, Executiveshall be required to execute in advance the Company’s then-current customary general release and waiver of any and all claimsof any kind, known and unknown, against the Company, its current and former parents, subsidiaries, affiliates, predecessorsand successors, and their respective current and former officers, directors, agents, employees, investors, attorneys, shareholders,fiduciaries, benefit plans, plan administrators, insurers, trustees and all persons acting with or on behalf of any of them (the“Releasees”), arising out of or relating in any way to (i) Executive’s employment with any of the Mylan Companies; (ii) anyacts or omissions of any of the Releasees during the course of Executive’s employment with any of the Mylan Companies; or(iii) the termination of Executive’s employment with any of the Mylan Companies, including but not limited to a release andwaiver of any and all such claims of any kind arising under all federal, state or local statutes, other laws, regulations or thecommon law; provided, however, that the release and waiver of claims shall exclude claims relating to vested pension benefits,deferred compensation arrangements, workers’ compensation benefits, unemployment compensation benefits, claims that ariseafter the release and waiver is signed by Executive and claims that cannot be released or waived under applicable law.9. Indemnification. The Company shall maintain D&O liability coverage pursuant to which Executive shall be a coveredinsured. Executive shall receive indemnification in accordance with the Company’s Bylaws in effect as of the date of this Agreement.Such indemnification shall be contractual in nature and shall remain in effect notwithstanding any future change to the Company’sBylaws.To the extent not otherwise limited by the Company’s Bylaws in effect as of the date of this Agreement, in the event thatExecutive is made a party or is threatened to be made a party to or is involved in any action, suit or proceeding, (including thosebrought by or in the right of the Company) whether civil, criminal, administrative or investigative (“proceeding”), by reason of the factthat he is or was an officer, employee or agent of or is or was serving the Company or any subsidiary of the Company, or is or wasserving at the request of the Company or another corporation, or of a partnership, joint venture, trust or other enterprise, includingservice with respect to employee benefit plans, whether the basis of such proceeding is alleged action in an official capacity as adirector, officer, employee or agent or in any other capacity while serving as a director, officer, employee or agent, Executive shall beindemnified and held harmless by the Company to the fullest extent authorized by law against all expenses, liabilities and losses(including attorneys fees, judgments, fines, ERISA excise taxes or penalties and amounts paid or to be paid in settlement) reasonablyincurred or suffered by Executive in connection therewith. Such right shall be a contract right and shall include the right to be paid bythe Company expenses incurred in defending any such proceeding in advance of its final disposition; provided, however, that thepayment of such expenses incurred by Executive in his capacity as a director or officer (and not in any other capacity in which servicewas or is rendered by Executive while a director or officer, including, without limitation, service to10an employee benefit plan) in advance of the final disposition of such proceeding will be made only upon delivery to the Company ofan undertaking, by or on behalf of Executive, to repay all amounts to the Company so advanced if it should be determined ultimatelythat Executive is not entitled to be indemnified under this section or otherwise.Promptly after receipt by Executive of notice of the commencement of any action, suit or proceeding for which Executive maybe entitled to be indemnified, Executive shall notify the Company in writing of the commencement thereof (but the failure to notify theCompany shall not relieve it from any liability which it may have under this Section 9 unless and to the extent that it has beenprejudiced in a material respect by such failure or from the forfeiture of substantial rights and defenses). If any such action, suit orproceeding is brought against Executive and he notifies the Company of the commencement thereof, the Company will be entitled toparticipate therein, and, to the extent it may elect by written notice delivered to Executive promptly after receiving the aforesaid noticefrom Executive, to assume the defense thereof with counsel reasonably satisfactory to Executive, which may be the same counsel ascounsel to the Company. Notwithstanding the foregoing, Executive shall have the right to employ his own counsel in any such case,but the fees and expenses of such counsel shall be at the expense of Executive unless (i) the employment of such counsel shall havebeen authorized in writing by the Company, (ii) the Company shall not have employed counsel reasonably satisfactory to Executive totake charge of the defense of such action within a reasonable time after notice of commencement of the action or (iii) Executive shallhave reasonably concluded, after consultation with counsel to Executive, that a conflict of interest exists which makes representationby counsel chosen by the Company not advisable (in which case the Company shall not have the right to direct the defense of suchaction on behalf of Executive), in any of which events such fees and expenses of one additional counsel shall be borne by theCompany. Anything in this Section 9 to the contrary notwithstanding, the Company shall not be liable for any settlement of any claimor action effected without its written consent.10. Other Agreements. The rights and obligations contained in this Agreement are in addition to and not in place of any rightsor obligations contained in any other agreements between Executive and the Company.11. Notices. All notices hereunder to the parties hereto shall be in writing sent by certified mail, return receipt requested,postage prepaid, and by fax, addressed to the respective parties at the following addresses:If to the Company: Mylan Inc.1000 Mylan Blvd.Canonsburg, Pennsylvania 15317Attn: Chief Legal OfficerFax: 724-514-1871If to Executive: at the most recent address on record at the Company.11Either party may, by written notice complying with the requirements of this section, specify another or different person oraddress for the purpose of notification hereunder. All notices shall be deemed to have been given and received on the day a fax is sentor, if mailed only, on the third business day following such mailing.12. Withholding. All payments required to be made by the Company hereunder to Executive or his dependents, beneficiariesor estate will be subject to the withholding of such amounts relating to tax and/or other payroll deductions as may be required by law.13. Modification and Waiver. This Agreement may not be changed or terminated orally, nor shall any change, termination orattempted waiver of any of the provisions contained in this Agreement be binding unless in writing and signed by the party againstwhom the same is sought to be enforced, nor shall this section itself by waived verbally. This Agreement may be amended only by awritten instrument duly executed by or on behalf of the parties hereto.14. Construction of Agreement. This Agreement and all of its provisions were subject to negotiation and shall not beconstrued more strictly against one party than against another party regardless of which party drafted any particular provision.15. Successors and Assigns. This Agreement and all of its provisions, rights and obligations shall be binding upon and inureto the benefit of the parties hereto and the Company’s successors and assigns. This Agreement may be assigned by the Company toany person, firm or corporation which shall become the owner of substantially all of the assets of the Company or which shall succeedto the business of the Company; provided, however, that in the event of any such assignment the Company shall obtain an instrumentin writing from the assignee in which such assignee assumes the obligations of the Company hereunder and shall deliver an executedcopy thereof to Executive. No right or interest to or in any payments or benefits hereunder shall be assignable by Executive; provided,however, that this provision shall not preclude him from designating one or more beneficiaries to receive any amount that may bepayable after his death and shall not preclude the legal representative of his estate from assigning any right hereunder to the person orpersons entitled thereto under his will or, in the case of intestacy, to the person or persons entitled thereto under the laws of intestacyapplicable to his estate. The term “beneficiaries” as used in this Agreement shall mean a beneficiary or beneficiary or beneficiaries sodesignated to receive any such amount, or if no beneficiary has been so designated, the legal representative of Executive’s estate. Noright, benefit or interest hereunder, shall be subject to anticipation, alienation, sale, assignment, encumbrance, charge, pledge,hypothecation or set-off in respect of any claim, debt, or obligation, or to execution, attachment, levy, or similar process, or assignmentby operation of law. Any attempt, voluntary or involuntary, to effect any action specified in the immediately preceding sentence shall,to the full extent permitted by law, be null, void and of no effect.1216. Choice of Law and Forum. This Agreement shall be construed and enforced according to, and the rights and obligationsof the parties shall be governed in all respects by, the laws of the State of New York. Any controversy, dispute or claim arising out ofor relating to this Agreement, or the breach hereof, including a claim for injunctive relief, or any claim which, in any way arises out ofor relates to, Executive’s employment with the Company or the termination of said employment, including but not limited to statutoryclaims for discrimination, shall be resolved by arbitration in accordance with the then current rules of the American ArbitrationAssociation respecting employment disputes except that the parties shall be entitled to engage in all forms of discovery permitted underthe New York Civil Practice Law and Rules (as such rules may be in effect from time to time). The hearing of any such dispute will beheld in New York, New York, and the losing party shall bear the costs, expenses and counsel fees of such proceeding. Executive andCompany agree for themselves, their, employees, successors and assigns and their accountants, attorneys and experts that anyarbitration hereunder will be held in complete confidence and, without the other party’s prior written consent, will not be disclosed, inwhole or in part, to any other person or entity except as may be required by law. The decision of the arbitrator(s) will be final andbinding on all parties. Executive and the Company expressly consent to the jurisdiction of any such arbitrator over them.17. Headings. The headings of the sections of this Agreement have been inserted for convenience of reference only and shallin no way affect the interpretation of any of the terms or conditions of this Agreement.18. Execution in Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemedan original, but all of which together shall constitute one and the same instrument.[Signature page follows]IN WITNESS WHEREOF, the undersigned have executed this Agreement on the day and year first above mentioned.MYLAN INC.,by /s/ JoEllen Lyons Dillon Name: JoEllen Lyons Dillon Title: Chair, Compensation Committeeof Mylan N.V. /s/ Rajiv Malik Rajiv MalikExhibit 10.21(b)EXECUTION VERSIONEXECUTIVE EMPLOYMENT AGREEMENTThis Executive Employment Agreement (the “Agreement”) is dated as of February 25, 2019, and effective as of April 1, 2019(the “Effective Date”), by and between Mylan Inc. (the “Company” or “Mylan”) and Anthony Mauro (“Executive”).RECITALS:WHEREAS, the Company wishes to retain Executive as Chief Commercial Officer but may be interested in utilizingExecutive in other capacities, in order to avail itself of Executive’s skills and abilities in light of the Company’s business needs; andWHEREAS, the Company is engaged in a business which is global in nature, involving businesses, business lines, operations,sales, customers, suppliers, manufacturing, research, technology and intellectual property located throughout the United States andinternationally; andNOW, THEREFORE, in consideration of the promises and mutual obligations of the parties contained herein, and for othervaluable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and Executive agree as follows:1.Employment of Executive; Best Efforts. Executive shall serve as Chief Commercial Officer of Mylan N.V., or insuch other capacity that permits the Company to avail itself of Executive’s skills and abilities in light of the Company’s business needsand consistent with the terms and conditions provided herein. In such roles, Executive shall have the duties, roles and responsibilitiestraditionally assigned to or commensurate with such roles and shall report to the President of Mylan N.V. Executive’s principal officeshall be in the Pittsburgh metropolitan area; provided Executive shall travel in connection with his employment in accordance with thereasonable direction of the President of Mylan N.V., commensurate with the activities of his position.2. Effective Date: Term of Employment. This Agreement shall commence and be effective as of the Effective Date and shallremain in effect, unless earlier terminated in accordance with the terms of this Agreement, through the third anniversary of the EffectiveDate (the “Third Anniversary”). Thereafter, this Agreement shall automatically renew for one (1) year periods (each period referred toas a “Renewal Term”) unless this Agreement is terminated in accordance with the terms of this Agreement. For purposes of thisAgreement, “Term of Employment” shall mean the period commencing on the Effective Date and ending on the date this Agreement isterminated in accordance with Section 9(e) of this Agreement or the date Executive’s employment and/or this Agreement is otherwiseterminated.3. Performance of Duties; Best Efforts. During the term of this Agreement, Executive shall devote his full working time andattention to the business and affairs of Mylan and the performance of his duties hereunder, serve Mylan faithfully and to the best of hisability, and use his best efforts to promote Mylan’s interests. During the term of this Agreement, Executive agrees to promptly and fullydisclose to Mylan, and not to divert to Executive’s own use or benefit or the use or benefit of others, any business opportunitiesinvolving any existing or prospective line of business, customer, supplier, product, or activity of Mylan or any business opportunitiesthat otherwise could be afforded to Mylan.4. Executive’s Compensation. Executive’s compensation shall be the following:(a) Annual Base Salary. Executive’s annual base salary (the “Annual Base Salary”) shall be Eight-Hundred ThousandDollars ($800,000), which shall be retroactive to January 1, 2019, payable in accordance with the Company’s normal payroll practicesfor its executive officers. The Annual Base Salary may be increased from time to time at the discretion of the Compensation Committeeof the Board of Directors of Mylan N.V. (the “Board”), or any other committee authorized by the Board.(b) Annual Bonus. Executive shall be eligible to participate in the Company’s annual discretionary executive incentiveor bonus plan as in effect from time to time, with the opportunity to receive an annual award in respect of each fiscal year of theCompany ending during the Term of Employment in accordance with the terms and conditions of such plan and subject to Executive’scontinued employment with the Company through the date such award is paid, with a target bonus opportunity equal to 115% ofAnnual Base Salary. Any such discretionary bonus shall be paid no later than March 15th of the year following the fiscal year to whichthe annual award relates.(c) Fringe Benefits and Expense Reimbursement. Executive shall receive benefits and perquisites of employmentsimilar to those as have been customarily provided to the Company’s other executive officers, including but not limited to, healthinsurance coverage, short-term disability benefits and twenty-five (25) vacation days, in each case in accordance with the plandocuments or policies that govern such benefits. Without limiting the foregoing, Executive shall receive an auto allowance in the grossamount of $1,600 per month. The Company shall reimburse Executive for all ordinary and necessary business expenses in accordancewith established Company policy and procedures.5. Confidentiality. Executive expressly acknowledges and agrees that, by reason of Executive’s position and employmentwith the Company, Executive may have a heightened level of access to the directors and senior executive officers (“Covered Persons”)of Mylan and its affiliate companies and parents (including Mylan N.V.) and subsidiaries (collectively, the “Mylan Companies”), andthat Executive consequently may have a heightened level of access to and/or knowledge of highly confidential, proprietary and non-public discussions, information, assessments and evaluations, strategies and/or2materials (hereafter “Covered Information”), the disclosure of which will or may injure the Mylan Companies and/or theirshareholders. Executive further acknowledges and agrees that the business interests of the Mylan Companies require a highlyconfidential relationship between the Company and Executive and the fullest protection and confidential treatment by Executive of theMylan Companies’ non-public: financial data and information; customer strategies, plans and information; supplier strategies, plans andinformation; market strategies, plans and information; marketing and/or promotional techniques, strategies, plans, policies and methods;pricing strategies, plans and information; purchasing strategies, plans and information; supply chain strategies, plans and information;sales strategies, plans, techniques, policies and information; employee lists; other policies and procedures; business records; advertisingstrategies, plans, techniques and information; computer records, programs and systems; trade secrets; know how; research anddevelopment plans, strategies, techniques and information; intellectual property and/or assessments of strategies relating to intellectualproperty, regardless of the owner of such intellectual property; regulatory plans, strategies and information; product plans andstrategies, including launch plans and assessments; business development plans, activities and strategies; plans and programs; sourcesof supply; earnings and other performance results, assessments and projections; risk assessments; Board and management deliberations,assessments and strategies; communications among or with Covered Persons regarding any and all matters referenced in thisparagraph; and all other proprietary or confidential information and trade secrets, Covered Information and other knowledge of thebusiness of the Mylan Companies (all of which are hereinafter jointly termed “Confidential Information”), which have been or may bein whole or in part conceived, learned, received or obtained by Executive in the course of Executive’s employment with the Company.Accordingly, Executive agrees to keep secret and treat as confidential all Confidential Information whether or not copyrightable orpatentable, and agrees not to disclose or use or aid others in learning of or using any Confidential Information except in the ordinarycourse of the Mylan Companies’ business and in furtherance of the Mylan Companies’ interests. For example, and not by way oflimitation, during the term of this Agreement and at all times thereafter, except insofar as is necessary consistent with Executive’sresponsibilities and the Mylan Companies’ best interests:(a) Executive will not, directly or indirectly, use or disclose any Confidential Information to anyone outside the MylanCompanies;(b) Executive will not make copies of or otherwise disclose the contents of documents containing or constitutingConfidential Information;(c) As to documents which are delivered to Executive or which are made available to or obtained by him as a part ofthe working relationships and duties of Executive within the business of the Mylan Companies, Executive will treat such documentsconfidentially and will treat such documents as proprietary and confidential, not to be reproduced, disclosed or used withoutappropriate authority of the Company;3(d) Executive will not advise others that the information and/or know how included in Confidential Information isknown to or used by the Mylan Companies; and(e) Executive will not in any manner disclose or use Confidential Information for Executive’s own or any third party’saccount and will not aid, assist or abet others in the use of Confidential Information for their account or benefit, or for the account orbenefit of any person or entity other than the Company.The obligations set forth in this paragraph are in addition to any other agreements Executive may have with the Company andany and all rights the Company may have under state or federal statutes or common law.Nothing in or about this Agreement prohibits Executive from: (i) filing and, as provided for under Section 21F of the SecuritiesExchange Act of 1934, maintaining the confidentiality of a claim with the Securities and Exchange Commission (the “SEC”); (ii)providing Confidential Information (as defined herein) to the SEC, or providing the SEC with information that would otherwise violateSection 5, to the extent permitted by Section 21F of the Securities Exchange Act of 1934; (iii) cooperating, participating or assisting inan SEC investigation or proceeding without notifying the Company; or (iv) receiving a monetary award as set forth in Section 21F ofthe Securities Exchange Act of 1934.Furthermore, Executive is advised that Executive shall not be held criminally or civilly liable under any federal or state tradesecret law for the disclosure of any Confidential Information (as defined herein) that constitutes a trade secret to which the DefendTrade Secrets Act (18 U.S.C. Section 1833(b)) applies that is made (i) in confidence to a federal, state or local government official,either directly or indirectly, or to an attorney, in each case, solely for the purpose of reporting or investigating a suspected violation oflaw or (ii) in a complaint or other document filed in a lawsuit or proceeding, if such filings are made under seal.6. Non-Competition and Non-Solicitation. Executive agrees that during the Term of Employment and for a period ending one(1) year after termination of Executive’s employment with the Company for any reason, or longer as provided in Section 8 of thisAgreement, and notwithstanding termination or expiration of this Agreement:(a) Executive shall not, directly or indirectly, whether for himself or for any other person, company, corporation orother entity, be or become employed or associated in any way (including but not limited to the association set forth in (i)-(vii) of thissubsection) with any business or organization which is directly or indirectly engaged in the research, development, manufacture,production, marketing, promotion or sale of any product the same as or similar to those of the Mylan Companies, or which competes orintends to compete in any line of business with the Mylan Companies. Notwithstanding the foregoing, Executive may during theperiod in which this paragraph4is in effect own stock or other interests in corporations or other entities that engage in businesses the same or substantially similar tothose engaged in by the Mylan Companies; provided that Executive does not, directly or indirectly (including without limitation as theresult of ownership or control of another corporation or other entity), individually or as part of a group (as that term is defined inSection 13(d) of the U.S. Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder) (i)control or have the ability to control the corporation or other entity; (ii) provide to the corporation or entity, whether as an Executive,consultant or otherwise, advice or consultation; (iii) provide to the corporation or entity any confidential or proprietary informationregarding the Mylan Companies or its businesses or regarding the conduct of businesses similar to those of the Mylan Companies; (iv)hold or have the right by contract or arrangement or understanding with other parties to hold a position on the board of directors orother governing body of the corporation or entity or have the right by contract or arrangement or understanding with other parties toelect one or more persons to any such position; (v) hold a position as an officer of the corporation or entity; (vi) have the purpose tochange or influence the control of the corporation or entity (other than solely by the voting of his shares or ownership interest); or (vii)have a business or other relationship, by contract or otherwise, with the corporation or entity other than as a passive investor in it;provided, however, that Executive may vote his shares or ownership interest in such manner as he chooses provided that such actiondoes not otherwise violate the prohibitions set forth in this sentence.(b) Executive will not, either directly or indirectly, either for himself or for any other person, partnership, firm,company, corporation or other entity, contact, solicit, divert, or take away any of the customers or suppliers of the Mylan Companies.(c) Executive will not solicit, entice or otherwise induce any employee of the Mylan Companies to leave the employ ofthe Mylan Companies for any reason whatsoever; nor will Executive directly or indirectly aid, assist or abet any other person or entityin soliciting or hiring any employee of the Mylan Companies, nor will Executive otherwise interfere with any contractual or otherbusiness relationships between the Mylan Companies and its employees.The obligations set forth in this Section 6 survive termination or expiration of this Agreement and termination of Executive’semployment and are in addition to any and all rights the Company may have under state or federal statutes, common law or otheragreements.7. Severability. In the event that any section, subsection, or provision hereof or of any surviving agreement made a part hereofbecomes or is declared by a court of competent jurisdiction or an arbitrator validly selected pursuant to Section 18 of this Agreement tobe illegal, unenforceable, or void, this Agreement shall continue in full force and effect without said section, subsection, or provision. Itis the intent of the parties that each section, subsection and provision of this Agreement be a separate and distinct promise and thatunenforceability of any one section, subsection, or provision5shall have no effect on the enforceability of another. Although the parties mutually agree that the post employment covenants inSections 5 and 6 of this Agreement are reasonable, necessary and drawn narrowly to protect the Mylan Companies’ legitimateinterests, if a court of competent jurisdiction or an arbitrator validly selected pursuant to Section 18 of this Agreement neverthelessfinds that such covenants are in whole or in part unreasonable or overly broad, the parties agree that such court or arbitrator shall havethe power to equitably reform such covenants in order to narrow the scope, including without limitation, the duration, of suchrestriction as may be deemed necessary to protect the Mylan Companies’ interests to the maximum extent deemed allowable by law.Notwithstanding the foregoing, in the event that the entirety of Section 6(a) is declared by a court of competent jurisdiction or arbitratorvalidly selected pursuant to Section 18 of this Agreement to be illegal, unenforceable or void, the Company shall be relieved of anyobligations to provide post-employment payments and benefits to Executive as set forth in Section 9(a) or 9(c), other than the AccruedAmounts (as defined below)8. Injunctive Relief. The parties agree that in the event of Executive’s violation of Sections 5 and/or 6 of this Agreement orany subsection thereunder, that the damage to the Company will be irreparable and that money damages will be difficult or impossibleto ascertain. Accordingly, in addition to whatever other remedies the Company may have at law or in equity, Executive recognizes andagrees that the Company shall be entitled to a temporary restraining order and a temporary and permanent injunction enjoining andprohibiting any acts not permissible pursuant to those sections of this Agreement. Executive agrees that should either party seek toenforce or determine its rights because of an act of Executive which the Company believes to be in contravention of Sections 5 and/or6 of this Agreement or any subsection thereunder, the duration of the restrictions imposed thereby shall be extended for a time periodequal to the period necessary to obtain judicial enforcement of the Company’s rights.9. Termination of Employment.(a) Resignation. (i) Executive may resign from employment at any time upon 90 days written notice to the ChiefExecutive Officer. During the 90-day notice period Executive shall continue to perform his duties under this Agreement and shallabide by all other terms and conditions of this Agreement. Additionally, Executive shall use his best efforts to effect a smooth andeffective transition to whoever will replace Executive. Mylan reserves the right to accelerate the effective date of Executive’sresignation.(ii) If Executive resigns without “Good Reason” (as defined below), Mylan shall have no liability or obligation toExecutive under this Agreement other than that Mylan shall pay Executive’s wages and benefits through the effective date ofExecutive’s termination of employment (the “Accrued Amounts”). Executive, however, will continue to be bound by allprovisions of this Agreement that survive termination of employment. For purposes of this Agreement, “Good Reason” shallmean: (1) a reduction of Executive’s Annual6Base Salary below the Annual Base Salary stipulated in this Agreement, unless other executive officers of the Company arerequired to accept a similar reduction; or (2) the assignment of duties to Executive that are inconsistent with those of anexecutive officer.(iii) If Executive resigns with Good Reason and complies in all respects with his obligations hereunder, Mylan shall payExecutive a lump sum amount equal to his then-current Annual Base Salary, plus a prorated annual bonus for the fiscal year inwhich Executive’s termination occurs (the “Pro Rata Bonus”), such Pro Rata Bonus to be determined by reference to the bonusthat Executive would have earned based on actual performance for the relevant fiscal year had Executive’s employment notterminated for Good Reason, with the resulting amount pro-rated to reflect the number of days elapsed in the fiscal year,through and including the date on which Executive’s termination of employment occurs. Subject to Section 9(h), any such ProRata Bonus payment shall be made if and when such bonus payments are made to other executives of the Company for therelevant fiscal year. For 12 months following Executive’s termination of employment, Mylan shall also continue to provide toExecutive and/or Executive’s dependents the health insurance benefits that were provided to them immediately prior toExecutive’s termination of employment (taking into account any required employee contributions, co-payments and similarcosts imposed on Executive) (the “Continuation Benefits”); provided, however, that Mylan’s obligation to provide theContinuation Benefits shall end at such time as Executive obtains health insurance benefits through another employer orotherwise in connection with rendering services for a third party and provided, further, that the parties agree to cooperate suchthat the Continuation Benefits are, to the extent practicable, provided in a manner so as to minimize adverse tax consequencesto the Company under Section 4980D of the Internal Revenue Code (the “Code”). In each case, Executive will continue to bebound by all provisions of this Agreement that survive termination of employment.(b) Termination for Cause. If Mylan determines to terminate Executive’s employment during the term of thisAgreement for “Cause” (as defined below) the Company shall have no liability to Executive other than to pay the Accrued Amounts.Executive, however, shall continue to be bound by all provisions of this Agreement that survive termination of employment. Forpurposes of this Agreement, “Cause” shall mean: (i) Executive’s willful and gross misconduct with respect to the business or affairs ofany of the Mylan Companies; (ii) Executive’s insubordination, gross neglect of duties, dishonesty or deliberate disregard of anymaterial rule or policy of any of the Mylan Companies; (iii) Executive’s conviction (including a plea of nolo contendere) for thecommission of a crime involving moral turpitude; or (iv) Executive’s conviction (including a plea of nolo contendere) of any felony.(c) Termination Without Cause. Mylan may terminate Executive’s employment at any time without Cause and,provided Executive complies in all respects7with his obligations hereunder, Mylan shall pay Executive a lump sum amount equal to his then-current Annual Base Salary, plus aPro Rata Bonus. Subject to Section 9(h), any such Pro Rata Bonus payment shall be made if and when such bonus payments are madeto other executives of the Company for the relevant fiscal year. For 12 months following Executive’s termination of employment,Mylan shall also provide to Executive and/or Executive’s dependents the Continuation Benefits; provided, however, that Mylan’sobligation to provide the Continuation Benefits shall end at such time as Executive obtains health insurance benefits through anotheremployer or otherwise in connection with rendering services for a third party and provided, further, that the parties agree to cooperatesuch that the Continuation Benefits are, to the extent practicable, provided in a manner so as to minimize adverse tax consequences tothe Company under Section 4980D of the Code. Executive will continue to be bound by all provisions of this Agreement that survivetermination of employment. Annual Base Salary and Bonus increases made during the first quarter of a calendar year shall not be takeninto account for purposes of Section 9 until April 1 of such calendar year.(d) Death or Incapacity. The employment of Executive shall automatically terminate upon Executive’s death or uponthe occurrence of a disability that renders Executive incapable of performing the essential functions of his position within the meaningof the Americans With Disabilities Act of 1990. For all purposes of this Agreement, any such termination shall be treated in the samemanner as a termination without Cause, as described in Section 9(c) above, and Executive, or Executive’s estate, as applicable, shallreceive all consideration, compensation and benefits that would be due and payable to Executive for a termination without Cause;provided, however, that such consideration, compensation and benefits shall be reduced by any death or disability benefits (asapplicable) that Executive or his estate or beneficiaries (as applicable) are entitled to pursuant to plans or arrangements of theCompany.(e) Non-Renewal. If the Company elects not to renew this Agreement, it may provide notice of nonrenewal no laterthan 30 days prior to the Third Anniversary or end of any Renewal Term, as applicable, and Executive’s employment shall terminateas of the Third Anniversary or the end of any Renewal Term, as applicable, and the Company shall pay Executive a lump sum amountequal the Annual Base Salary, which amount shall be paid within 30 days following Executive’s separation from the Company(subject to Section 9(h)) below). For 12 months following a nonrenewal of this Agreement, Mylan shall also provide to Executiveand/or Executive’s dependents the Continuation Benefits; provided, however, that Mylan’s obligation to provide the ContinuationBenefits shall end at such time as Executive obtains health insurance benefits through another employer or otherwise in connectionwith rendering services for a third party and provided, further, that the parties agree to cooperate such that the Continuation Benefitsare, to the extent practicable, provided in a manner so as to minimize adverse tax consequences to the Company under Section 4980Dof the Code. Executive will continue to be bound by all provisions of this Agreement that survive termination of employment.8(f) Return of Company Property. Upon the termination of Executive’s employment for any reason, Executive shallimmediately return to Mylan all records, memoranda, files, notes, papers, correspondence, reports, documents, books, diskettes, harddrives, electronic and digital files and materials of any kind, and all copies or abstracts thereof that Executive has concerning any or allof the Mylan Companies’ business. Executive shall also immediately return all keys, identification cards or badges, Company leased orowned automobiles (if any), and other Company property.(g) No Duty to Mitigate. There shall be no requirement on the part of Executive to seek other employment orotherwise mitigate damages in order to be entitled to the full amount of any payments and benefits to which Executive is otherwiseentitled under any contract and, except as set forth herein with respect to the Continuation Benefits, the amount of such payments andbenefits shall not be reduced by any compensation or benefits received by Executive from other employment.(h) Release. (i) In order to receive any payments or benefits under this Section 9, other than the Accrued Amounts,Executive shall be required to execute in advance the Company’s customary general release and waiver of any and all claims of anykind, known and unknown, against the Company, its current and former parents, subsidiaries, affiliates, predecessors and successors,and their respective current and former officers, directors, agents, employees, investors, attorneys, shareholders, fiduciaries, benefitplans, plan administrators, insurers, trustees and all persons acting with or on behalf of any of them (the “Releasees”), arising out of orrelating in any way to (i) Executive’s employment with any of the Mylan Companies; (ii) any acts or omissions of any of the Releaseesduring the course of Executive’s employment with any of the Mylan Companies; or (iii) the termination of Executive’s employmentwith any of the Mylan Companies, including but not limited to a release and waiver of any and all such claims of any kind arisingunder all federal, state or local statutes, other laws, regulations or the common law; provided, however, that the release and waiver ofclaims shall exclude claims relating to vested pension benefits, deferred compensation arrangements, workers’ compensation benefits,unemployment compensation benefits, claims that arise after the release and waiver is signed by Executive and claims that cannot bereleased or waived under applicable law.(ii) Subject to any six-month delay required pursuant to Section 20 of this Agreement, payment of the amounts due toEmployee under Sections 9 of this Agreement, other than the Accrued Amounts, shall commence on the first payroll date occurringafter the sixtieth (60th) day following Employee’s termination of employment (or, in the discretion of the Company, such earlier date asis permitted by Section 409A of Code); provided that the release has been executed and has become non-revocable prior to anypayment hereunder. Unless otherwise provided by the Company, if the release and waiver of claims does not become effective andirrevocable prior to the first payment date specified above, Employee shall not be entitled to any payments or benefits pursuant toSections 9 of this Agreement, other than the Accrued Amounts. In addition, payments and the Continuation Benefits pursuant toSection 9 of this Agreement, shall be expressly9contingent upon Employee’s continued performance of Employee’s obligations under this Agreement, including, but not limited to,Sections 5, 6 and 9(f) of this Agreement.10. Indemnification. The Company shall maintain D&O liability coverage pursuant to which Executive shall be a coveredinsured. Executive shall receive indemnification in accordance with Mylan N.V’s Articles of Association (the “Articles”) in effect as ofthe date of this Agreement. Such indemnification shall be contractual in nature and shall remain in effect notwithstanding any futurechange to the Articles.To the extent not otherwise limited by the Articles in effect as of the date of this Agreement, in the event that Executive is madea party or is threatened to be made a party to or is involved in any action, suit or proceeding, (including those brought by or in the rightof the Company or Mylan N.V.) whether civil, criminal, administrative or investigative (“proceeding”), by reason of the fact that he isor was an officer, employee or agent of or is or was serving any Mylan Company, or is or was serving at the request of the Companyor another corporation, or of a partnership, joint venture, trust or other enterprise, including service with respect to employee benefitplans, whether the basis of such proceeding is alleged action in an official capacity as a director, officer, employee or agent or in anyother capacity while serving as a director, officer, employee or agent, Executive shall be indemnified and held harmless by applicableMylan Company to the fullest extent authorized by law against all expenses, liabilities and losses (including attorneys fees, judgments,fines, ERISA excise taxes or penalties and amounts paid or to be paid in settlement) reasonably incurred or suffered by Executive inconnection therewith. Such right shall be a contract right and shall include the right to be paid by the applicable Mylan Companyexpenses incurred in defending any such proceeding in advance of its final disposition; provided, however, that the payment of suchexpenses incurred by Executive in his capacity as a director or officer (and not in any other capacity in which service was or isrendered by Executive while a director or officer, including, without limitation, service to an employee benefit plan) in advance of thefinal disposition of such proceeding will be made only upon delivery to the applicable Mylan Company of an undertaking, by or onbehalf of Executive, to repay all amounts to the applicable Mylan Company so advanced if it should be determined ultimately thatExecutive is not entitled to be indemnified under this section or otherwise.Promptly after receipt by Executive of notice of the commencement of any action, suit or proceeding for which Executive maybe entitled to be indemnified, Executive shall notify the applicable Mylan Company in writing of the commencement thereof (but thefailure to notify such Mylan Company shall not relieve it from any liability which it may have under this Section 10 unless and to theextent that it has been prejudiced in a material respect by such failure or from the forfeiture of substantial rights and defenses). If anysuch action, suit or proceeding is brought against Executive and he notifies the applicable Mylan Company of the commencementthereof, such Mylan Company will be entitled to participate therein, and, to the extent it may elect by written notice delivered toExecutive promptly after receiving the aforesaid notice from Executive, to assume the defense thereof with counsel reasonablysatisfactory to Executive, which may be the10same counsel as counsel to such Mylan Company. Notwithstanding the foregoing, Executive shall have the right to employ his owncounsel in any such case, but the fees and expenses of such counsel shall be at the expense of Executive unless (i) the employment ofsuch counsel shall have been authorized in writing by the applicable Mylan Company, (ii) the applicable Mylan Company shall nothave employed counsel reasonably satisfactory to Executive to take charge of the defense of such action within a reasonable time afternotice of commencement of the action or (iii) Executive shall have reasonably concluded, after consultation with counsel to Executive,that a conflict of interest exists which makes representation by counsel chosen by the applicable Mylan Company not advisable (inwhich case such Mylan Company shall not have the right to direct the defense of such action on behalf of Executive), in any of whichevents such fees and expenses of one additional counsel shall be borne by the applicable Mylan Company. Anything in this Section 10to the contrary notwithstanding, the applicable Mylan Company shall not be liable for any settlement of any claim or action effectedwithout its written consent.11. Other Agreements. This Agreement, together with the Agreement Relating to Patents, Copyrights, Inventions,Confidentiality and Proprietary Information (“Confidentiality Agreement”) and the Transition and Succession Agreement, sets forth theentire agreement and understanding between the Mylan Companies and Employee with respect to the subject matter herein andsupersedes all prior written and oral agreements, discussions, or representations between the Mylan Companies and Employeeconcerning the subjects addressed herein (collectively, “Prior Arrangements”). To the extent that there is any conflict between theterms of this Agreement, the Confidentiality Agreement, the Transition and Succession Agreement, and any Prior Arrangement, thisAgreement shall govern and control.12. Notices. All notices hereunder to the parties hereto shall be in writing sent by certified mail, return receipt requested,postage prepaid, and by fax, addressed to the respective parties at the following addresses:If to the Company:Mylan Inc. 1000 Mylan Blvd. Canonsburg, Pennsylvania 15317 Attn: Chief Legal Officer Fax: 724-514-1871If to Executive:at the most recent address on record at the Company.Either party may, by written notice complying with the requirements of this section, specify another or different person or address forthe purpose of notification hereunder. All notices shall be deemed to have been given and received on the day a fax is sent or, if mailedonly, on the third business day following such mailing.13. Withholding. All payments required to be made by the Company hereunder to Executive or his dependents, beneficiariesor estate will be subject to the11withholding of such amounts relating to tax and/or other payroll deductions as may be required by law.14. Modification and Waiver. This Agreement may not be changed or terminated, nor shall any change, termination orattempted waiver of any of the provisions contained in this Agreement be binding unless in writing and signed by the party againstwhom the same is sought to be enforced, nor shall this section itself by waived verbally. This Agreement may be amended only by awritten instrument duly executed by or on behalf of the parties hereto.15. Construction of Agreement. This Agreement and all of its provisions were subject to negotiation and shall not beconstrued more strictly against one party than against another party regardless of which party drafted any particular provision.16. Successors and Assigns. This Agreement and all of its provisions, rights and obligations shall be binding upon and inureto the benefit of the parties hereto and the Company’s successors and assigns. This Agreement may be assigned by the Company toany person, firm or corporation which shall become the owner of substantially all of the assets of the Company or which shall succeedto the business of the Company; provided, however, that in the event of any such assignment the Company shall obtain an instrumentin writing from the assignee in which such assignee assumes the obligations of the Company hereunder and shall deliver an executedcopy thereof to Executive. No right or interest to or in any payments or benefits hereunder shall be assignable by Executive; provided,however, that this provision shall not preclude him from designating one or more beneficiaries to receive any amount that may bepayable after his death and shall not preclude the legal representative of his estate from assigning any right hereunder to the person orpersons entitled thereto under his will or, in the case of intestacy, to the person or persons entitled thereto under the laws of intestacyapplicable to his estate. The term “beneficiaries” as used in this Agreement shall mean a beneficiary or beneficiaries so designated toreceive any such amount, or if no beneficiary has been so designated, the legal representative of Executive’s estate. No right, benefit,or interest hereunder, shall be subject to anticipation, alienation, sale, assignment, encumbrance, charge, pledge, hypothecation, or set-off in respect of any claim, debt, or obligation, or to execution, attachment, levy, or similar process, or assignment by operation of law.Any attempt, voluntary or involuntary, to effect any action specified in the immediately preceding sentence shall, to the full extentpermitted by law, be null, void and of no effect.17. Choice of Law. This Agreement shall be construed and enforced according to, and the rights and obligations of the partiesshall be governed in all respects by, the laws of the Commonwealth of Pennsylvania.18. Disputes, Arbitration, and Consent to Jurisdiction.(a) Any controversy, dispute or claim arising out of or relating to this Agreement, or the breach hereof, including aclaim for injunctive relief, or any claim which, in any way arises out of or relates to, Executive’s employment with the Company12or the termination of said employment, including but not limited to statutory claims for discrimination, shall be resolved by arbitrationin accordance with the then current rules of the American Arbitration Association respecting employment disputes except that theparties shall be entitled to engage in all forms of discovery permitted under the Pennsylvania Rules of Civil Procedure (as such rulesmay be in effect from time to time). Executive agrees that Executive may only commence an action in arbitration, or assertcounterclaims in an arbitration, on an individual basis and, thus, Executive hereby waives Executive’s right to commence or participatein any class or collective action(s) against the Mylan Companies, as permitted by law. The hearing of any such dispute will be held inPittsburgh, Pennsylvania, and the losing party shall bear the costs, expenses and counsel fees of such proceeding. Executive andCompany agree for themselves, their, employees, successors and assigns and their accountants, attorneys and experts that anyarbitration hereunder will be held in complete confidence and, without the other party’s prior written consent, will not be disclosed, inwhole or in part, to any other person or entity except as may be required by law. The decision of the arbitrator(s) will be final andbinding on all parties. Executive and the Company expressly consent to the jurisdiction of any such arbitrator over them.(b) Notwithstanding the foregoing, either party may request a court of competent jurisdiction to issue such temporaryor interim relief (including temporary restraining orders and preliminary injunctions) as may be appropriate, either before arbitration iscommenced or pending the outcome of arbitration, whether either party alleges or claims a violation of this Agreement or any otheragreement regarding trade secrets, confidential information, non-competition or non-solicitation. No such request shall be a waiver ofthe right to submit any claim, dispute or controversy to arbitration.(c) In the event either party commences any court action as permitted by subparagraph (b) above, each of the partieshereto irrevocably submits to the exclusive jurisdiction of (i) the Court of Common Pleas of Washington County, Pennsylvania and (ii)the United States District Court for the Western District of Pennsylvania, for the purposes of any suit, action, or other proceedingarising out of in or any way relating to this Agreement or Executive’s employment, and agrees not to commence any action, suit orproceeding relating thereto except in such courts. Each of the parties hereto further agrees that service of any process, summons, noticeor document hand delivered or sent by U.S. certified mail to such party’s respective address set forth in Section 12 of this Agreementwill be effective service of process for any action, suit or proceeding in Pennsylvania with respect to any matters to which it hassubmitted to jurisdiction as set forth in the immediately preceding sentence. Each of the parties hereto irrevocably and unconditionallywaives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement in (i) the Court of CommonPleas of Washington County, Pennsylvania or (ii) the United States District Court for the Western District of Pennsylvania, and herebyfurther irrevocably and unconditionally waives and agrees not to plead or claim in any such court that such action, suit or proceedingbrought in such court has been brought in an inconvenient forum.1319. Non-Disparagement. During the term hereof and thereafter, Executive agrees to refrain from any disparaging statements,including but not limited to statements that amount to libel or slander, about any of the Mylan Companies and/or any of their respectiveemployees, officers, or directors.20. Conditions to Payment and Acceleration; Section 409A of the Code. The intent of the parties is that payments and benefitsunder this Agreement comply with Section 409A of the Code to the extent subject thereto, and, accordingly, to the maximum extentpermitted, this Agreement shall be interpreted and administered to be in compliance therewith. Notwithstanding anything containedherein to the contrary, to the extent required in order to avoid accelerated taxation and/or tax penalties under Section 409A of the Code,Executive shall not be considered to have terminated employment with the Company for purposes of this Agreement and no paymentsshall be due to Executive under Section 9 of this Agreement until Executive would be considered to have incurred a “separation fromservice” from the Company within the meaning of Section 409A of the Code. For purposes of this Agreement, each amount to be paidor benefit to be provided shall be construed as a separate identified payment for purposes of Section 409A of the Code, and anypayments described in Section 9 that are due within the “short term deferral period” as defined in Section 409A of the Code shall notbe treated as deferred compensation unless applicable law requires otherwise. To the extent required in order to avoid acceleratedtaxation and/or tax penalties under Section 409A of the Code, amounts that would otherwise be payable and benefits that wouldotherwise be provided pursuant to this Agreement during the six-month period immediately following Executive’s termination ofemployment shall instead be paid on the first business day after the date that is six months following Executive’s termination ofemployment (or death, if earlier). To the extent required to avoid an accelerated or additional tax under Section 409A of the Code,amounts reimbursable to Executive under this Agreement shall be paid to Executive on or before the last day of the year following theyear in which the expense was incurred and the amount of expenses eligible for reimbursement (and in-kind benefits provided toExecutive) during any one year may not affect amounts reimbursable or provided in any subsequent year; provided, however, that withrespect to any reimbursements for any taxes which Executive would become entitled to under the terms of the Agreement, the paymentof such reimbursements shall be made by the Company no later than the end of the calendar year following the calendar year in whichExecutive remits the related taxes.21. Headings. The headings of the sections of this Agreement have been inserted for convenience of reference only and shallin no way affect the interpretation of any of the terms or conditions of this Agreement.22. Execution in Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemedan original, but all of which together shall constitute one and the same instrument.[Signature page follows]14IN WITNESS WHEREOF, the undersigned have executed this Agreement on the day and year first above mentioned.MYLAN INC. EXECUTIVE:/s/ Heather Bresch /s/ Anthony MauroName:Heather Bresch Anthony MauroTitle:Chief Executive Officer of Mylan N.V Exhibit 10.22(b)EXECUTION VERSIONEXECUTIVE EMPLOYMENT AGREEMENTThis Executive Employment Agreement (the “Agreement”) is dated as of February 25, 2019, and effective as of April 1, 2019(the “Effective Date”), by and between Mylan Inc. (the “Company” or “Mylan”) and Kenneth S. Parks (“Executive”).RECITALS:WHEREAS, the Company wishes to retain Executive as Chief Financial Officer but may be interested in utilizing Executive inother capacities, in order to avail itself of Executive’s skills and abilities in light of the Company’s business needs; andWHEREAS, the Company is engaged in a business which is global in nature, involving businesses, business lines, operations,sales, customers, suppliers, manufacturing, research, technology and intellectual property located throughout the United States andinternationally; andNOW, THEREFORE, in consideration of the promises and mutual obligations of the parties contained herein, and for othervaluable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and Executive agree as follows:1.Employment of Executive; Best Efforts. Executive shall serve as Chief Financial Officer of Mylan N.V., or in suchother capacity that permits the Company to avail itself of Executive’s skills and abilities in light of the Company’s business needs andconsistent with the terms and conditions provided herein. In such roles, Executive shall have the duties, roles and responsibilitiestraditionally assigned to or commensurate with such roles and shall report to the Chief Executive Officer of Mylan N.V. Executive’sprincipal office shall be in the Pittsburgh metropolitan area; provided Executive shall travel in connection with his employment inaccordance with the reasonable direction of the Chief Executive Officer of Mylan N.V., commensurate with the activities of hisposition.2. Effective Date: Term of Employment. This Agreement shall commence and be effective as of the Effective Date and shallremain in effect, unless earlier terminated in accordance with the terms of this Agreement, through the third anniversary of the EffectiveDate (the “Third Anniversary”). Thereafter, this Agreement shall automatically renew for one (1) year periods (each period referred toas a “Renewal Term”) unless this Agreement is terminated in accordance with the terms of this Agreement. For purposes of thisAgreement, “Term of Employment” shall mean the period commencing on the Effective Date and ending on the date this Agreement isterminated in accordance with Section 9(e) of this Agreement or the date Executive’s employment and/or this Agreement is otherwiseterminated.3. Performance of Duties; Best Efforts. During the term of this Agreement, Executive shall devote his full working time andattention to the business and affairs of Mylan and the performance of his duties hereunder, serve Mylan faithfully and to the best of hisability, and use his best efforts to promote Mylan’s interests. During the term of this Agreement, Executive agrees to promptly and fullydisclose to Mylan, and not to divert to Executive’s own use or benefit or the use or benefit of others, any business opportunitiesinvolving any existing or prospective line of business, customer, supplier, product, or activity of Mylan or any business opportunitiesthat otherwise could be afforded to Mylan.4. Executive’s Compensation. Executive’s compensation shall be the following:(a) Annual Base Salary. Executive’s annual base salary (the “Annual Base Salary”) shall be Eight-Hundred ThousandDollars ($800,000), which shall be retroactive to January 1, 2019, payable in accordance with the Company’s normal payroll practicesfor its executive officers. The Annual Base Salary may be increased from time to time at the discretion of the Compensation Committeeof the Board of Directors of Mylan N.V. (the “Board”), or any other committee authorized by the Board.(b) Annual Bonus. Executive shall be eligible to participate in the Company’s annual discretionary executive incentiveor bonus plan as in effect from time to time, with the opportunity to receive an annual award in respect of each fiscal year of theCompany ending during the Term of Employment in accordance with the terms and conditions of such plan and subject to Executive’scontinued employment with the Company through the date such award is paid, with a target bonus opportunity equal to 115% ofAnnual Base Salary. Any such discretionary bonus shall be paid no later than March 15th of the year following the fiscal year to whichthe annual award relates.(c) Fringe Benefits and Expense Reimbursement. Executive shall receive benefits and perquisites of employmentsimilar to those as have been customarily provided to the Company’s other executive officers, including but not limited to, healthinsurance coverage, short-term disability benefits and twenty-five (25) vacation days, in each case in accordance with the plandocuments or policies that govern such benefits. Without limiting the foregoing, Executive shall receive an auto allowance in the grossamount of $1,600 per month. The Company shall reimburse Executive for all ordinary and necessary business expenses in accordancewith established Company policy and procedures.5. Confidentiality. Executive expressly acknowledges and agrees that, by reason of Executive’s position and employmentwith the Company, Executive may have a heightened level of access to the directors and senior executive officers (“Covered Persons”)of Mylan and its affiliate companies and parents (including Mylan N.V.) and2subsidiaries (collectively, the “Mylan Companies”), and that Executive consequently may have a heightened level of access to and/orknowledge of highly confidential, proprietary and non-public discussions, information, assessments and evaluations, strategies and/ormaterials (hereafter “Covered Information”), the disclosure of which will or may injure the Mylan Companies and/or theirshareholders. Executive further acknowledges and agrees that the business interests of the Mylan Companies require a highlyconfidential relationship between the Company and Executive and the fullest protection and confidential treatment by Executive of theMylan Companies’ non-public: financial data and information; customer strategies, plans and information; supplier strategies, plans andinformation; market strategies, plans and information; marketing and/or promotional techniques, strategies, plans, policies and methods;pricing strategies, plans and information; purchasing strategies, plans and information; supply chain strategies, plans and information;sales strategies, plans, techniques, policies and information; employee lists; other policies and procedures; business records; advertisingstrategies, plans, techniques and information; computer records, programs and systems; trade secrets; know how; research anddevelopment plans, strategies, techniques and information; intellectual property and/or assessments of strategies relating to intellectualproperty, regardless of the owner of such intellectual property; regulatory plans, strategies and information; product plans andstrategies, including launch plans and assessments; business development plans, activities and strategies; plans and programs; sourcesof supply; earnings and other performance results, assessments and projections; risk assessments; Board and management deliberations,assessments and strategies; communications among or with Covered Persons regarding any and all matters referenced in thisparagraph; and all other proprietary or confidential information and trade secrets, Covered Information and other knowledge of thebusiness of the Mylan Companies (all of which are hereinafter jointly termed “Confidential Information”), which have been or may bein whole or in part conceived, learned, received or obtained by Executive in the course of Executive’s employment with the Company.Accordingly, Executive agrees to keep secret and treat as confidential all Confidential Information whether or not copyrightable orpatentable, and agrees not to disclose or use or aid others in learning of or using any Confidential Information except in the ordinarycourse of the Mylan Companies’ business and in furtherance of the Mylan Companies’ interests. For example, and not by way oflimitation, during the term of this Agreement and at all times thereafter, except insofar as is necessary consistent with Executive’sresponsibilities and the Mylan Companies’ best interests:(a) Executive will not, directly or indirectly, use or disclose any Confidential Information to anyone outside the MylanCompanies;(b) Executive will not make copies of or otherwise disclose the contents of documents containing or constitutingConfidential Information;(c) As to documents which are delivered to Executive or which are made available to or obtained by him as a part ofthe working relationships and duties of Executive within the business of the Mylan Companies, Executive will treat such3documents confidentially and will treat such documents as proprietary and confidential, not to be reproduced, disclosed or used withoutappropriate authority of the Company;(d) Executive will not advise others that the information and/or know how included in Confidential Information isknown to or used by the Mylan Companies; and(e) Executive will not in any manner disclose or use Confidential Information for Executive’s own or any third party’saccount and will not aid, assist or abet others in the use of Confidential Information for their account or benefit, or for the account orbenefit of any person or entity other than the Company.The obligations set forth in this paragraph are in addition to any other agreements Executive may have with the Company andany and all rights the Company may have under state or federal statutes or common law.Nothing in or about this Agreement prohibits Executive from: (i) filing and, as provided for under Section 21F of the SecuritiesExchange Act of 1934, maintaining the confidentiality of a claim with the Securities and Exchange Commission (the “SEC”); (ii)providing Confidential Information (as defined herein) to the SEC, or providing the SEC with information that would otherwise violateSection 5, to the extent permitted by Section 21F of the Securities Exchange Act of 1934; (iii) cooperating, participating or assisting inan SEC investigation or proceeding without notifying the Company; or (iv) receiving a monetary award as set forth in Section 21F ofthe Securities Exchange Act of 1934.Furthermore, Executive is advised that Executive shall not be held criminally or civilly liable under any federal or state tradesecret law for the disclosure of any Confidential Information (as defined herein) that constitutes a trade secret to which the DefendTrade Secrets Act (18 U.S.C. Section 1833(b)) applies that is made (i) in confidence to a federal, state or local government official,either directly or indirectly, or to an attorney, in each case, solely for the purpose of reporting or investigating a suspected violation oflaw or (ii) in a complaint or other document filed in a lawsuit or proceeding, if such filings are made under seal.6. Non-Competition and Non-Solicitation. Executive agrees that during the Term of Employment and for a period ending one(1) year after termination of Executive’s employment with the Company for any reason, or longer as provided in Section 8 of thisAgreement, and notwithstanding termination or expiration of this Agreement:(a) Executive shall not, directly or indirectly, whether for himself or for any other person, company, corporation orother entity, be or become employed or associated in any way (including but not limited to the association set forth in (i)-(vii) of thissubsection) with any business or organization which is directly or indirectly engaged in the research, development, manufacture,production, marketing, promotion or sale of4any product the same as or similar to those of the Mylan Companies, or which competes or intends to compete in any line of businesswith the Mylan Companies. Notwithstanding the foregoing, Executive may during the period in which this paragraph is in effect ownstock or other interests in corporations or other entities that engage in businesses the same or substantially similar to those engaged inby the Mylan Companies; provided that Executive does not, directly or indirectly (including without limitation as the result ofownership or control of another corporation or other entity), individually or as part of a group (as that term is defined in Section 13(d)of the U.S. Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder) (i) control or have theability to control the corporation or other entity; (ii) provide to the corporation or entity, whether as an Executive, consultant orotherwise, advice or consultation; (iii) provide to the corporation or entity any confidential or proprietary information regarding theMylan Companies or its businesses or regarding the conduct of businesses similar to those of the Mylan Companies; (iv) hold or havethe right by contract or arrangement or understanding with other parties to hold a position on the board of directors or other governingbody of the corporation or entity or have the right by contract or arrangement or understanding with other parties to elect one or morepersons to any such position; (v) hold a position as an officer of the corporation or entity; (vi) have the purpose to change or influencethe control of the corporation or entity (other than solely by the voting of his shares or ownership interest); or (vii) have a business orother relationship, by contract or otherwise, with the corporation or entity other than as a passive investor in it; provided, however, thatExecutive may vote his shares or ownership interest in such manner as he chooses provided that such action does not otherwise violatethe prohibitions set forth in this sentence.(b) Executive will not, either directly or indirectly, either for himself or for any other person, partnership, firm,company, corporation or other entity, contact, solicit, divert, or take away any of the customers or suppliers of the Mylan Companies.(c) Executive will not solicit, entice or otherwise induce any employee of the Mylan Companies to leave the employ ofthe Mylan Companies for any reason whatsoever; nor will Executive directly or indirectly aid, assist or abet any other person or entityin soliciting or hiring any employee of the Mylan Companies, nor will Executive otherwise interfere with any contractual or otherbusiness relationships between the Mylan Companies and its employees.The obligations set forth in this Section 6 survive termination or expiration of this Agreement and termination of Executive’semployment and are in addition to any and all rights the Company may have under state or federal statutes, common law or otheragreements.7. Severability. In the event that any section, subsection, or provision hereof or of any surviving agreement made a part hereofbecomes or is declared by a court of competent jurisdiction or an arbitrator validly selected pursuant to Section 18 of this Agreement tobe illegal, unenforceable, or void, this Agreement shall continue in full5force and effect without said section, subsection, or provision. It is the intent of the parties that each section, subsection and provisionof this Agreement be a separate and distinct promise and that unenforceability of any one section, subsection, or provision shall haveno effect on the enforceability of another. Although the parties mutually agree that the post employment covenants in Sections 5 and 6of this Agreement are reasonable, necessary and drawn narrowly to protect the Mylan Companies’ legitimate interests, if a court ofcompetent jurisdiction or an arbitrator validly selected pursuant to Section 18 of this Agreement nevertheless finds that such covenantsare in whole or in part unreasonable or overly broad, the parties agree that such court or arbitrator shall have the power to equitablyreform such covenants in order to narrow the scope, including without limitation, the duration, of such restriction as may be deemednecessary to protect the Mylan Companies’ interests to the maximum extent deemed allowable by law. Notwithstanding the foregoing,in the event that the entirety of Section 6(a) is declared by a court of competent jurisdiction or arbitrator validly selected pursuant toSection 18 of this Agreement to be illegal, unenforceable or void, the Company shall be relieved of any obligations to provide post-employment payments and benefits to Executive as set forth in Section 9(a) or 9(c), other than the Accrued Amounts (as definedbelow)8. Injunctive Relief. The parties agree that in the event of Executive’s violation of Sections 5 and/or 6 of this Agreement orany subsection thereunder, that the damage to the Company will be irreparable and that money damages will be difficult or impossibleto ascertain. Accordingly, in addition to whatever other remedies the Company may have at law or in equity, Executive recognizes andagrees that the Company shall be entitled to a temporary restraining order and a temporary and permanent injunction enjoining andprohibiting any acts not permissible pursuant to those sections of this Agreement. Executive agrees that should either party seek toenforce or determine its rights because of an act of Executive which the Company believes to be in contravention of Sections 5 and/or6 of this Agreement or any subsection thereunder, the duration of the restrictions imposed thereby shall be extended for a time periodequal to the period necessary to obtain judicial enforcement of the Company’s rights.9. Termination of Employment.(a) Resignation. (i) Executive may resign from employment at any time upon 90 days written notice to the ChiefExecutive Officer. During the 90-day notice period Executive shall continue to perform his duties under this Agreement and shallabide by all other terms and conditions of this Agreement. Additionally, Executive shall use his best efforts to effect a smooth andeffective transition to whoever will replace Executive. Mylan reserves the right to accelerate the effective date of Executive’sresignation.(ii) If Executive resigns without “Good Reason” (as defined below), Mylan shall have no liability or obligation toExecutive under this Agreement other than that Mylan shall pay Executive’s wages and benefits through the effective date ofExecutive’s termination of employment (the “Accrued6Amounts”). Executive, however, will continue to be bound by all provisions of this Agreement that survive termination ofemployment. For purposes of this Agreement, “Good Reason” shall mean: (1) a reduction of Executive’s Annual Base Salarybelow the Annual Base Salary stipulated in this Agreement, unless other executive officers of the Company are required toaccept a similar reduction; or (2) the assignment of duties to Executive that are inconsistent with those of an executive officer.(iii) If Executive resigns with Good Reason and complies in all respects with his obligations hereunder, Mylan shall payExecutive a lump sum amount equal to his then-current Annual Base Salary, plus a prorated annual bonus for the fiscal year inwhich Executive’s termination occurs (the “Pro Rata Bonus”), such Pro Rata Bonus to be determined by reference to the bonusthat Executive would have earned based on actual performance for the relevant fiscal year had Executive’s employment notterminated for Good Reason, with the resulting amount pro-rated to reflect the number of days elapsed in the fiscal year,through and including the date on which Executive’s termination of employment occurs. Subject to Section 9(h), any such ProRata Bonus payment shall be made if and when such bonus payments are made to other executives of the Company for therelevant fiscal year. For 12 months following Executive’s termination of employment, Mylan shall also continue to provide toExecutive and/or Executive’s dependents the health insurance benefits that were provided to them immediately prior toExecutive’s termination of employment (taking into account any required employee contributions, co-payments and similarcosts imposed on Executive) (the “Continuation Benefits”); provided, however, that Mylan’s obligation to provide theContinuation Benefits shall end at such time as Executive obtains health insurance benefits through another employer orotherwise in connection with rendering services for a third party and provided, further, that the parties agree to cooperate suchthat the Continuation Benefits are, to the extent practicable, provided in a manner so as to minimize adverse tax consequencesto the Company under Section 4980D of the Internal Revenue Code (the “Code”). In each case, Executive will continue to bebound by all provisions of this Agreement that survive termination of employment.(b) Termination for Cause. If Mylan determines to terminate Executive’s employment during the term of thisAgreement for “Cause” (as defined below) the Company shall have no liability to Executive other than to pay the Accrued Amounts.Executive, however, shall continue to be bound by all provisions of this Agreement that survive termination of employment. Forpurposes of this Agreement, “Cause” shall mean: (i) Executive’s willful and gross misconduct with respect to the business or affairs ofany of the Mylan Companies; (ii) Executive’s insubordination, gross neglect of duties, dishonesty or deliberate disregard of anymaterial rule or policy of any of the Mylan Companies; (iii) Executive’s conviction (including a plea of nolo contendere) for thecommission of a crime involving moral turpitude; or (iv) Executive’s conviction (including a plea of nolo contendere) of any felony.7(c) Termination Without Cause. Mylan may terminate Executive’s employment at any time without Cause and,provided Executive complies in all respects with his obligations hereunder, Mylan shall pay Executive a lump sum amount equal to histhen-current Annual Base Salary, plus a Pro Rata Bonus. Subject to Section 9(h), any such Pro Rata Bonus payment shall be made ifand when such bonus payments are made to other executives of the Company for the relevant fiscal year. For 12 months followingExecutive’s termination of employment, Mylan shall also provide to Executive and/or Executive’s dependents the ContinuationBenefits; provided, however, that Mylan’s obligation to provide the Continuation Benefits shall end at such time as Executive obtainshealth insurance benefits through another employer or otherwise in connection with rendering services for a third party and provided,further, that the parties agree to cooperate such that the Continuation Benefits are, to the extent practicable, provided in a manner so asto minimize adverse tax consequences to the Company under Section 4980D of the Code. Executive will continue to be bound by allprovisions of this Agreement that survive termination of employment. Annual Base Salary and Bonus increases made during the firstquarter of a calendar year shall not be taken into account for purposes of Section 9 until April 1 of such calendar year.(d) Death or Incapacity. The employment of Executive shall automatically terminate upon Executive’s death or uponthe occurrence of a disability that renders Executive incapable of performing the essential functions of his position within the meaningof the Americans With Disabilities Act of 1990. For all purposes of this Agreement, any such termination shall be treated in the samemanner as a termination without Cause, as described in Section 9(c) above, and Executive, or Executive’s estate, as applicable, shallreceive all consideration, compensation and benefits that would be due and payable to Executive for a termination without Cause;provided, however, that such consideration, compensation and benefits shall be reduced by any death or disability benefits (asapplicable) that Executive or his estate or beneficiaries (as applicable) are entitled to pursuant to plans or arrangements of theCompany.(e) Non-Renewal. If the Company elects not to renew this Agreement, it may provide notice of nonrenewal no laterthan 30 days prior to the Third Anniversary or end of any Renewal Term, as applicable, and Executive’s employment shall terminateas of the Third Anniversary or the end of any Renewal Term, as applicable, and the Company shall pay Executive a lump sum amountequal the Annual Base Salary, which amount shall be paid within 30 days following Executive’s separation from the Company(subject to Section 9(h)) below). For 12 months following a nonrenewal of this Agreement, Mylan shall also provide to Executiveand/or Executive’s dependents the Continuation Benefits; provided, however, that Mylan’s obligation to provide the ContinuationBenefits shall end at such time as Executive obtains health insurance benefits through another employer or otherwise in connectionwith rendering services for a third party and provided, further, that the parties agree to cooperate such that the Continuation Benefitsare, to the extent practicable, provided in a manner so as to minimize adverse tax consequences to the Company under Section 4980Dof the Code.8Executive will continue to be bound by all provisions of this Agreement that survive termination of employment.(f) Return of Company Property. Upon the termination of Executive’s employment for any reason, Executive shallimmediately return to Mylan all records, memoranda, files, notes, papers, correspondence, reports, documents, books, diskettes, harddrives, electronic and digital files and materials of any kind, and all copies or abstracts thereof that Executive has concerning any or allof the Mylan Companies’ business. Executive shall also immediately return all keys, identification cards or badges, Company leased orowned automobiles (if any), and other Company property.(g) No Duty to Mitigate. There shall be no requirement on the part of Executive to seek other employment orotherwise mitigate damages in order to be entitled to the full amount of any payments and benefits to which Executive is otherwiseentitled under any contract and, except as set forth herein with respect to the Continuation Benefits, the amount of such payments andbenefits shall not be reduced by any compensation or benefits received by Executive from other employment.(h) Release. (i) In order to receive any payments or benefits under this Section 9, other than the Accrued Amounts,Executive shall be required to execute in advance the Company’s customary general release and waiver of any and all claims of anykind, known and unknown, against the Company, its current and former parents, subsidiaries, affiliates, predecessors and successors,and their respective current and former officers, directors, agents, employees, investors, attorneys, shareholders, fiduciaries, benefitplans, plan administrators, insurers, trustees and all persons acting with or on behalf of any of them (the “Releasees”), arising out of orrelating in any way to (i) Executive’s employment with any of the Mylan Companies; (ii) any acts or omissions of any of the Releaseesduring the course of Executive’s employment with any of the Mylan Companies; or (iii) the termination of Executive’s employmentwith any of the Mylan Companies, including but not limited to a release and waiver of any and all such claims of any kind arisingunder all federal, state or local statutes, other laws, regulations or the common law; provided, however, that the release and waiver ofclaims shall exclude claims relating to vested pension benefits, deferred compensation arrangements, workers’ compensation benefits,unemployment compensation benefits, claims that arise after the release and waiver is signed by Executive and claims that cannot bereleased or waived under applicable law.(ii) Subject to any six-month delay required pursuant to Section 20 of this Agreement, payment of the amounts due toEmployee under Sections 9 of this Agreement, other than the Accrued Amounts, shall commence on the first payroll date occurringafter the sixtieth (60th) day following Employee’s termination of employment (or, in the discretion of the Company, such earlier date asis permitted by Section 409A of Code); provided that the release has been executed and has become non-revocable prior to anypayment hereunder. Unless otherwise provided by the Company, if the release and waiver of claims does not become effective andirrevocable prior to the first payment date9specified above, Employee shall not be entitled to any payments or benefits pursuant to Sections 9 of this Agreement, other than theAccrued Amounts. In addition, payments and the Continuation Benefits pursuant to Section 9 of this Agreement, shall be expresslycontingent upon Employee’s continued performance of Employee’s obligations under this Agreement, including, but not limited to,Sections 5, 6 and 9(f) of this Agreement.10. Indemnification. The Company shall maintain D&O liability coverage pursuant to which Executive shall be a coveredinsured. Executive shall receive indemnification in accordance with Mylan N.V’s Articles of Association (the “Articles”) in effect as ofthe date of this Agreement. Such indemnification shall be contractual in nature and shall remain in effect notwithstanding any futurechange to the Articles.To the extent not otherwise limited by the Articles in effect as of the date of this Agreement, in the event that Executive is madea party or is threatened to be made a party to or is involved in any action, suit or proceeding, (including those brought by or in the rightof the Company or Mylan N.V.) whether civil, criminal, administrative or investigative (“proceeding”), by reason of the fact that he isor was an officer, employee or agent of or is or was serving any Mylan Company, or is or was serving at the request of the Companyor another corporation, or of a partnership, joint venture, trust or other enterprise, including service with respect to employee benefitplans, whether the basis of such proceeding is alleged action in an official capacity as a director, officer, employee or agent or in anyother capacity while serving as a director, officer, employee or agent, Executive shall be indemnified and held harmless by applicableMylan Company to the fullest extent authorized by law against all expenses, liabilities and losses (including attorneys fees, judgments,fines, ERISA excise taxes or penalties and amounts paid or to be paid in settlement) reasonably incurred or suffered by Executive inconnection therewith. Such right shall be a contract right and shall include the right to be paid by the applicable Mylan Companyexpenses incurred in defending any such proceeding in advance of its final disposition; provided, however, that the payment of suchexpenses incurred by Executive in his capacity as a director or officer (and not in any other capacity in which service was or isrendered by Executive while a director or officer, including, without limitation, service to an employee benefit plan) in advance of thefinal disposition of such proceeding will be made only upon delivery to the applicable Mylan Company of an undertaking, by or onbehalf of Executive, to repay all amounts to the applicable Mylan Company so advanced if it should be determined ultimately thatExecutive is not entitled to be indemnified under this section or otherwise.Promptly after receipt by Executive of notice of the commencement of any action, suit or proceeding for which Executive maybe entitled to be indemnified, Executive shall notify the applicable Mylan Company in writing of the commencement thereof (but thefailure to notify such Mylan Company shall not relieve it from any liability which it may have under this Section 10 unless and to theextent that it has been prejudiced in a material respect by such failure or from the forfeiture of substantial rights and defenses). If anysuch action, suit or proceeding is brought against Executive and he notifies the applicable Mylan Company of the commencementthereof, such Mylan Company will be10entitled to participate therein, and, to the extent it may elect by written notice delivered to Executive promptly after receiving theaforesaid notice from Executive, to assume the defense thereof with counsel reasonably satisfactory to Executive, which may be thesame counsel as counsel to such Mylan Company. Notwithstanding the foregoing, Executive shall have the right to employ his owncounsel in any such case, but the fees and expenses of such counsel shall be at the expense of Executive unless (i) the employment ofsuch counsel shall have been authorized in writing by the applicable Mylan Company, (ii) the applicable Mylan Company shall nothave employed counsel reasonably satisfactory to Executive to take charge of the defense of such action within a reasonable time afternotice of commencement of the action or (iii) Executive shall have reasonably concluded, after consultation with counsel to Executive,that a conflict of interest exists which makes representation by counsel chosen by the applicable Mylan Company not advisable (inwhich case such Mylan Company shall not have the right to direct the defense of such action on behalf of Executive), in any of whichevents such fees and expenses of one additional counsel shall be borne by the applicable Mylan Company. Anything in this Section 10to the contrary notwithstanding, the applicable Mylan Company shall not be liable for any settlement of any claim or action effectedwithout its written consent.11. Other Agreements. This Agreement, together with the Agreement Relating to Patents, Copyrights, Inventions,Confidentiality and Proprietary Information (“Confidentiality Agreement”) and the Transition and Succession Agreement, sets forth theentire agreement and understanding between the Mylan Companies and Employee with respect to the subject matter herein andsupersedes all prior written and oral agreements, discussions, or representations between the Mylan Companies and Employeeconcerning the subjects addressed herein (collectively, “Prior Arrangements”). To the extent that there is any conflict between theterms of this Agreement, the Confidentiality Agreement, the Transition and Succession Agreement, and any Prior Arrangement, thisAgreement shall govern and control.12. Notices. All notices hereunder to the parties hereto shall be in writing sent by certified mail, return receipt requested,postage prepaid, and by fax, addressed to the respective parties at the following addresses:If to the Company:Mylan Inc. 1000 Mylan Blvd. Canonsburg, Pennsylvania 15317 Attn: Chief Legal Officer Fax: 724-514-1871If to Executive:at the most recent address on record at the Company.Either party may, by written notice complying with the requirements of this section, specify another or different person or address forthe purpose of notification hereunder. All notices shall be deemed to have been given and received on the day a fax is sent or, if mailedonly, on the third business day following such mailing.1113. Withholding. All payments required to be made by the Company hereunder to Executive or his dependents, beneficiariesor estate will be subject to the withholding of such amounts relating to tax and/or other payroll deductions as may be required by law.14. Modification and Waiver. This Agreement may not be changed or terminated, nor shall any change, termination orattempted waiver of any of the provisions contained in this Agreement be binding unless in writing and signed by the party againstwhom the same is sought to be enforced, nor shall this section itself by waived verbally. This Agreement may be amended only by awritten instrument duly executed by or on behalf of the parties hereto.15. Construction of Agreement. This Agreement and all of its provisions were subject to negotiation and shall not beconstrued more strictly against one party than against another party regardless of which party drafted any particular provision.16. Successors and Assigns. This Agreement and all of its provisions, rights and obligations shall be binding upon and inureto the benefit of the parties hereto and the Company’s successors and assigns. This Agreement may be assigned by the Company toany person, firm or corporation which shall become the owner of substantially all of the assets of the Company or which shall succeedto the business of the Company; provided, however, that in the event of any such assignment the Company shall obtain an instrumentin writing from the assignee in which such assignee assumes the obligations of the Company hereunder and shall deliver an executedcopy thereof to Executive. No right or interest to or in any payments or benefits hereunder shall be assignable by Executive; provided,however, that this provision shall not preclude him from designating one or more beneficiaries to receive any amount that may bepayable after his death and shall not preclude the legal representative of his estate from assigning any right hereunder to the person orpersons entitled thereto under his will or, in the case of intestacy, to the person or persons entitled thereto under the laws of intestacyapplicable to his estate. The term “beneficiaries” as used in this Agreement shall mean a beneficiary or beneficiaries so designated toreceive any such amount, or if no beneficiary has been so designated, the legal representative of Executive’s estate. No right, benefit,or interest hereunder, shall be subject to anticipation, alienation, sale, assignment, encumbrance, charge, pledge, hypothecation, or set-off in respect of any claim, debt, or obligation, or to execution, attachment, levy, or similar process, or assignment by operation of law.Any attempt, voluntary or involuntary, to effect any action specified in the immediately preceding sentence shall, to the full extentpermitted by law, be null, void and of no effect.17. Choice of Law. This Agreement shall be construed and enforced according to, and the rights and obligations of the partiesshall be governed in all respects by, the laws of the Commonwealth of Pennsylvania.18. Disputes, Arbitration, and Consent to Jurisdiction.12(a) Any controversy, dispute or claim arising out of or relating to this Agreement, or the breach hereof, including aclaim for injunctive relief, or any claim which, in any way arises out of or relates to, Executive’s employment with the Company or thetermination of said employment, including but not limited to statutory claims for discrimination, shall be resolved by arbitration inaccordance with the then current rules of the American Arbitration Association respecting employment disputes except that the partiesshall be entitled to engage in all forms of discovery permitted under the Pennsylvania Rules of Civil Procedure (as such rules may be ineffect from time to time). Executive agrees that Executive may only commence an action in arbitration, or assert counterclaims in anarbitration, on an individual basis and, thus, Executive hereby waives Executive’s right to commence or participate in any class orcollective action(s) against the Mylan Companies, as permitted by law. The hearing of any such dispute will be held in Pittsburgh,Pennsylvania, and the losing party shall bear the costs, expenses and counsel fees of such proceeding. Executive and Company agreefor themselves, their, employees, successors and assigns and their accountants, attorneys and experts that any arbitration hereunder willbe held in complete confidence and, without the other party’s prior written consent, will not be disclosed, in whole or in part, to anyother person or entity except as may be required by law. The decision of the arbitrator(s) will be final and binding on all parties.Executive and the Company expressly consent to the jurisdiction of any such arbitrator over them.(b) Notwithstanding the foregoing, either party may request a court of competent jurisdiction to issue such temporaryor interim relief (including temporary restraining orders and preliminary injunctions) as may be appropriate, either before arbitration iscommenced or pending the outcome of arbitration, whether either party alleges or claims a violation of this Agreement or any otheragreement regarding trade secrets, confidential information, non-competition or non-solicitation. No such request shall be a waiver ofthe right to submit any claim, dispute or controversy to arbitration.(c) In the event either party commences any court action as permitted by subparagraph (b) above, each of the partieshereto irrevocably submits to the exclusive jurisdiction of (i) the Court of Common Pleas of Washington County, Pennsylvania and (ii)the United States District Court for the Western District of Pennsylvania, for the purposes of any suit, action, or other proceedingarising out of in or any way relating to this Agreement or Executive’s employment, and agrees not to commence any action, suit orproceeding relating thereto except in such courts. Each of the parties hereto further agrees that service of any process, summons, noticeor document hand delivered or sent by U.S. certified mail to such party’s respective address set forth in Section 12 of this Agreementwill be effective service of process for any action, suit or proceeding in Pennsylvania with respect to any matters to which it hassubmitted to jurisdiction as set forth in the immediately preceding sentence. Each of the parties hereto irrevocably and unconditionallywaives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement in (i) the Court of CommonPleas of Washington County, Pennsylvania or (ii) the United States District Court for the Western District of Pennsylvania, and herebyfurther irrevocably and unconditionally waives and13agrees not to plead or claim in any such court that such action, suit or proceeding brought in such court has been brought in aninconvenient forum.19. Non-Disparagement. During the term hereof and thereafter, Executive agrees to refrain from any disparaging statements,including but not limited to statements that amount to libel or slander, about any of the Mylan Companies and/or any of their respectiveemployees, officers, or directors.20. Conditions to Payment and Acceleration; Section 409A of the Code. The intent of the parties is that payments and benefitsunder this Agreement comply with Section 409A of the Code to the extent subject thereto, and, accordingly, to the maximum extentpermitted, this Agreement shall be interpreted and administered to be in compliance therewith. Notwithstanding anything containedherein to the contrary, to the extent required in order to avoid accelerated taxation and/or tax penalties under Section 409A of the Code,Executive shall not be considered to have terminated employment with the Company for purposes of this Agreement and no paymentsshall be due to Executive under Section 9 of this Agreement until Executive would be considered to have incurred a “separation fromservice” from the Company within the meaning of Section 409A of the Code. For purposes of this Agreement, each amount to be paidor benefit to be provided shall be construed as a separate identified payment for purposes of Section 409A of the Code, and anypayments described in Section 9 that are due within the “short term deferral period” as defined in Section 409A of the Code shall notbe treated as deferred compensation unless applicable law requires otherwise. To the extent required in order to avoid acceleratedtaxation and/or tax penalties under Section 409A of the Code, amounts that would otherwise be payable and benefits that wouldotherwise be provided pursuant to this Agreement during the six-month period immediately following Executive’s termination ofemployment shall instead be paid on the first business day after the date that is six months following Executive’s termination ofemployment (or death, if earlier). To the extent required to avoid an accelerated or additional tax under Section 409A of the Code,amounts reimbursable to Executive under this Agreement shall be paid to Executive on or before the last day of the year following theyear in which the expense was incurred and the amount of expenses eligible for reimbursement (and in-kind benefits provided toExecutive) during any one year may not affect amounts reimbursable or provided in any subsequent year; provided, however, that withrespect to any reimbursements for any taxes which Executive would become entitled to under the terms of the Agreement, the paymentof such reimbursements shall be made by the Company no later than the end of the calendar year following the calendar year in whichExecutive remits the related taxes.21. Headings. The headings of the sections of this Agreement have been inserted for convenience of reference only and shallin no way affect the interpretation of any of the terms or conditions of this Agreement.1422. Execution in Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemedan original, but all of which together shall constitute one and the same instrument.[Signature page follows]IN WITNESS WHEREOF, the undersigned have executed this Agreement on the day and year first above mentioned.MYLAN INC. EXECUTIVE:/s/ Heather Bresch /s/ Kenneth S. ParksName:Heather Bresch Kenneth S. ParksTitle:Chief Executive Officer of Mylan N.V 15Exhibit 10.23(b)EXECUTION VERSIONCONSULTING AGREEMENTThis Consulting Agreement (“Agreement”) is made by and between Daniel M. Gallagher (“Gallagher”) and Mylan Inc. (the“Company”) (collectively referred to as the “Parties” or individually referred to as a “Party”).RECITALSWHEREAS, Gallagher and the Company executed an Executive Employment Agreement on March 24, 2017 (the“Employment Agreement”), which, among other matters, provides for certain terms and conditions regarding Gallagher’s employmentwith, and separation from, the Company, including without limitation obligations that survive termination of the EmploymentAgreement and termination of Gallagher’s employment with the Company, as specified in Section 21 of this Agreement;WHEREAS, Mylan and Gallagher have announced that Gallagher will separate from employment with the Company effectiveas of April 2, 2019 (the “Separation Date”);WHEREAS, the Company wishes to continue to utilize Gallagher’s services in a consulting capacity for twelve months afterthe Separation Date; andWHEREAS, the Company and Gallagher wish to reach an agreement regarding the terms of Gallagher’s separation fromemployment and consultancy to the Company.NOW, THEREFORE, in consideration of the mutual promises made herein and intending to be legally bound hereby, theCompany and Gallagher hereby agree as follows:COVENANTS1.Consideration and Other Terms of Separation. Effective as of the Separation Date, Gallagher shall resign from allpositions as an executive, officer or employee of the Company and all of its subsidiaries, and he shall cease to be Chief Legal Officerof the Company. Provided that Gallagher does not revoke his acceptance of this Agreement during the seven (7) day revocation periodidentified in Section 24 below and does not commit a material breach of this Agreement, as described in Section 12 below:a. In exchange for the Consulting Services (as defined in Section 7), the Company agrees to pay Gallagher an amountequal to six hundred thousand dollars ($600,000) in equal monthly installments ($50,000 per month) during the one-year ConsultingPeriod (as defined in Section 7). Each installment shall be paid no later than fifteen (15) days after the end of each calendar monthduring the Consulting Period (i.e., May 15th, June 15th, July 15th, etc.), in each case less applicable deductions and withholdings.b. Subject to Gallagher’s provision of the Consulting Services until the end of the Consulting Period (except asprovided in Section 7(f)) and his not committing a material breach of this Agreement, on March 15, 2020, and notwithstanding anyprior regular vesting dates, Gallagher will become vested in the restricted stock units set forth on Schedule A of this Agreement. Allother unvested awards granted under the 2003 Long-Term Incentive Plan, as amended, will be forfeited as of the Separation Date.c. Pursuant to Section 9(f) of the Employment Agreement, the Company agrees to pay Gallagher an amount equal toeight hundred thousand dollars ($800,000) within thirty (30) days of the Separation Date, less applicable deductions and withholdings.d. Gallagher’s group benefits shall cease at the end of the month of the Separation Date (meaning April 30, 2019);provided that Gallagher shall remain entitled to the Continuation Benefits as defined in Section 9(a)(iii) of the Employment Agreementin accordance with, and subject to, the terms and conditions of, Section 9(f) of the Employment Agreement.e. Subject to Gallagher’s provision of the Consulting Services until the end of the Consulting Period (except asprovided in Section 7(f)) and his not committing a material breach of this Agreement, on April 2, 2020, or as soon as practicablethereafter, and notwithstanding any prior regular vesting dates, the Company will pay Gallagher the value of the unvested balance ofhis 401(k) plan and 401(k) restoration plan accounts as of the Separation Date.f. Except as specified herein, Gallagher’s participation in all benefits and incidents of employment, including, but notlimited to, the accrual of bonuses, vacation, and paid time off, and any additional 401(k) plan contributions, shall cease as of theSeparation Date. Vested amounts payable to Gallagher under the Company’s 401(k) and other retirement plans or agreements will bepaid in accordance with the terms of such plans and agreements and applicable law (except as provided in Section 1(e)). All paymentshereunder shall be subject to applicable deductions and withholdings as required by law.2. Payment of Salary and Receipt of All Benefits. Gallagher acknowledges and represents that, other than the consideration tobe paid pursuant to this Agreement, Gallagher’s final regular pay on the Company’s next regularly scheduled payroll date after theSeparation Date and payment for all unused and accrued vacation time as of the Separation Date (which will be included inGallagher’s final regular pay on the Company’s next regularly scheduled payroll date after the Separation Date, subject to applicabledeductions and withholding), the Company has paid or provided all salary, wages, bonuses, accrued vacation/paid time off, premiums,leaves, reimbursable expenses, stock, stock options, vesting, shares pursuant to vested restricted stock units, and any and all otherbenefits and compensation due to Gallagher by the Company and its affiliates. Gallagher acknowledges that all equity-based awards(other than those set forth on Schedule A of this Agreement) that are unvested as of the Separation Date will be forfeited as of theSeparation Date. To receive reimbursement for any final Company-related travel expenses, Gallagher must submit a final report of allsuch outstanding expenses within thirty (30)2calendar days after the Separation Date, accompanied by receipts and otherwise subject to the Company’s expense reimbursementpolicy.3. Release of Claims. In consideration of the payments to be made under Sections 1(a), 1(b) and 1(e) of this Agreement,which Gallagher acknowledges he would not otherwise be entitled to receive, Gallagher agrees that the foregoing considerationrepresents settlement in full of all outstanding obligations owed to Gallagher by the Company and its current and former officers,directors, employees, agents, investors, attorneys, shareholders, administrators, affiliates, direct and indirect parents and subsidiaries,benefit plans, plan administrators, insurers, trustees, divisions, and subsidiaries, predecessor and successor corporations and assigns,and all persons acting with or on behalf of them (collectively, the “Releasees”). The parties acknowledge and agree that the amountspaid for Gallagher’s consulting services under this Agreement are in lieu of any payments for consulting or similar services under anyother plan or agreement during the Consulting Period covered by this Agreement. Gallagher, on his own behalf and on behalf of hisheirs, family members, executors, agents, and assigns, hereby and forever releases and discharges the Releasees from any and allclaims, complaints, charges, duties, obligations, demands, or causes of action relating to any matters of any kind, whether presentlyknown or unknown, suspected or unsuspected, that Gallagher may possess against any of the Releasees arising from any omissions,acts, failures to act, facts, or damages that have occurred up until and including the date Gallagher executes this Agreement, including,without limitation:a. any and all claims relating to or arising from Gallagher’s employment relationship with the Company and/or any ofthe Releasees and the termination of that relationship;b. any and all claims relating to, or arising from, Gallagher’s right to purchase, or actual purchase of shares of stock ofthe Company and/or any of the Releasees, including, without limitation, any claims for fraud, misrepresentation, breach of fiduciaryduty, breach of duty under applicable state corporate law, and securities fraud under any state or federal law;c. any and all claims for wrongful discharge of employment; termination in violation of public policy; discrimination;harassment; retaliation; breach of contract, both express and implied; breach of covenant of good faith and fair dealing, both expressand implied; promissory estoppel; negligent or intentional infliction of emotional distress; fraud; negligent or intentionalmisrepresentation; negligent or intentional interference with contract or prospective economic advantage; unfair business practices;defamation; libel; slander; negligence; personal injury; assault; battery; invasion of privacy; false imprisonment; conversion; anddisability benefits;d. any and all claims under any policy, agreement, understanding or promise, written or oral, formal or informal,between any Releasee and Gallagher existing as of the date hereof (whether or not known or arising before, on or after the dateGallagher executes this Agreement);3e. any and all claims for violation of any federal, state, or municipal statute, including, but not limited to, Title VII ofthe Civil Rights Act of 1964; the Civil Rights Act of 1991; the Rehabilitation Act of 1973; the Americans with Disabilities Act of1990; the Equal Pay Act; the Fair Labor Standards Act; the Fair Credit Reporting Act; the Age Discrimination in Employment Act of1967; the Older Workers Benefit Protection Act; the Employee Retirement Income Security Act of 1974; the Worker Adjustment andRetraining Notification Act; the Family and Medical Leave Act; the Sarbanes-Oxley Act of 2002; the laws and Constitution of theCommonwealth of Pennsylvania, each as amended, or any other federal, state or local law, regulation ordinance or common law;f. any and all claims for violation of the federal or any state constitution;g. any and all claims arising out of any other laws and regulations relating to employment or employmentdiscrimination;h. any claim for any loss, cost, damage, or expense arising out of any dispute over the non-withholding or other taxtreatment of any of the proceeds received by Gallagher as a result of this Agreement;i. any and all claims for attorneys’ fees and costs; andj. any other claims whatsoever.Gallagher agrees that the Release set forth in this section shall be and remain in effect in all respects as a complete general release as tothe matters released. This Release does not extend to any obligations incurred under this Agreement, surviving rights of Gallagherunder his Employment Agreement, including but not limited to indemnification rights, any claims accruing after execution of thisAgreement, or any rights Gallagher may have under any D&O insurance policy maintained by the Company and/or any of theReleasees. This Release does not release claims that cannot be released as a matter of law, including, but not limited to, Gallagher’sright to file a charge with or participate in a charge by the Equal Employment Opportunity Commission, or any other local, state, orfederal administrative body or government agency that is authorized to enforce or administer laws related to employment, against theCompany (with the understanding that any such filing or participation does not give Gallagher the right to recover any monetarydamages against the Company and/or any of the Releasees; and Gallagher’s release of claims herein bars Gallagher from recoveringsuch monetary relief from the Company and/or any of the Releasees). Gallagher represents that he has made no assignment or transferof any right, claim, complaint, charge, duty, obligation, demand, cause of action, or other matter waived or released by this Section.4. Acknowledgment that Waiver of Claims is Knowing and Voluntary. Gallagher acknowledges that he is waiving andreleasing any rights he may have under the Age Discrimination in Employment Act of 1967 (“ADEA’’) and that this waiver andrelease is knowing and voluntary. Gallagher agrees that this waiver and release does not apply to any rights or claims that may ariseunder the ADEA after the date Gallagher executes this Agreement. Gallagher acknowledges that the consideration given for thiswaiver and release is in addition to4anything of value to which Gallagher was already entitled. Gallagher further acknowledges that he has been advised by this writingthat: (a) he should consult with an attorney prior to executing this Agreement; (b) he has twenty-one (21) days within which toconsider this Agreement; (c) he has seven (7) days following his execution of this Agreement to revoke this Agreement and may do soby writing to the Company’s General Counsel; (d) this Agreement shall not be effective until after the revocation period has expiredwithout revocation; and (e) nothing in this Agreement prevents or precludes Gallagher from challenging or seeking a determination ingood faith of the validity of this waiver under the ADEA, nor does it impose any condition precedent, penalties, or costs for doing so,unless specifically authorized by federal law. In the event Gallagher signs this Agreement and returns it to the Company in less than the21-day period identified above, Gallagher hereby acknowledges that he has freely and voluntarily chosen to waive the time periodallotted for considering this Agreement.5. Unknown Claims. Gallagher acknowledges that he has been advised to consult with legal counsel and that he is familiarwith the principle that a general release does not extend to claims that the releaser does not know or suspect to exist in his favor at thetime of executing the release, which, if known by him, must have materially affected his settlement with the Releasee. Gallagher, beingaware of said principle, agrees to expressly waive any rights he may have to that effect, as well as under any other statute or commonlaw principles of similar effect.6. No Pending or Future Lawsuits. Gallagher represents that he has no lawsuits, claims, or actions pending in his name, or onbehalf of any other person or entity, against the Company or any of the other Releasees. Gallagher also represents that he does notintend to bring any claims on his own behalf or on behalf of any other person or entity against the Company or any of the otherReleasees.7. Consulting Services. The Company and Gallagher agree that, commencing on April 2, 2019, Gallagher will be available atreasonable times and upon reasonable notice to perform the consulting services described herein (the “Consulting Services”) on behalfof the Company and/or any of its subsidiaries and affiliates until the close of business on April 1, 2020 (such period, the “ConsultingPeriod”).a. Gallagher shall provide such consulting and other services as may reasonably be required of Gallagher by theChairman, Chief Executive Officer or Chief Legal Officer, which services shall relate to historic and background matters (includingwith respect to any legal or other advice given to or received by the Company) applicable to the Company and/or any subsidiary oraffiliate’s business affairs, business decisions, or operations known to Gallagher by virtue of his employment with the Company orotherwise. For the avoidance of doubt, without limiting the prior sentence with respect to consultation regarding historical legal mattersor advice, Gallagher shall not provide legal advice to Mylan after the Separation Date.b. Gallagher shall use his best efforts in his performance of services hereunder, including such care, resources, effort,knowledge and expertise as a reasonably prudent person experienced in and knowledgeable of such matters and duties of the kind andcharacter contemplated herein would exercise under the circumstances.5c. The Parties acknowledge and agree that the consideration provided in this Agreement constitutes adequate andcomplete compensation for Gallagher’s consulting and other services as set forth herein.d. The Company shall reimburse Gallagher for reasonable expenses directly related to the provision of services, whichexpenses or costs are approved by the Chairman or Chief Executive Officer. Gallagher shall provide to the Chairman or ChiefExecutive Officer, on a monthly basis, documentation (in reasonable detail) of all expenses for which reimbursement is requested, andsuch approved expenses shall be paid to Gallagher as promptly as reasonably practicable after receipt of such documentation.e. Nothing in this Agreement shall be construed to create an employment relationship between Gallagher and theCompany after the Separation Date. During the Consulting Period, (a) Gallagher shall be an independent contractor and shall have noauthority to enter into contracts on behalf of the Company, bind the Company to any third parties, or act as an agent on behalf of theCompany in any regard; (b) without limitation to Section 1, Gallagher shall not be entitled to receive any compensation or medical orother benefits as a Company employee; (c) Gallagher shall remain subject to the continuing obligations set forth in the EmploymentAgreement, as specified in Section 21 of this Agreement; and (d) the level of Gallagher’s services shall be consistent with theincurrence of a “separation from service” (as defined in Section 409A of the Internal Revenue Code) as of the Separation Date(meaning no more than 20% of the average level of services Gallagher performed over the previous 36 months) and in no event shallexceed 25 hours per month without the mutual agreement of the parties.f. Gallagher may, upon no less than 15 days’ written notice to the Company, terminate the Consulting Period prior toApril 1, 2020, but only in the event that Gallagher commences employment with another entity, and such new employer instructsGallagher in writing that Gallagher may not provide the Consulting Services while being employed by such employer; provided that insuch event, the Company shall cease making payments under Section 1(a) and shall not provide vesting or make any payment pursuantto Section 1(b) or 1(e), but Gallagher shall remain subject to all of his obligations under this Agreement (other than his obligation toprovide Consulting Services); provided, however, that if Gallagher provides such written notice to the Company on or after June 1,2019, the Company shall provide the vesting pursuant to Section 1(b) and shall settle such awards on March 15, 2020.8. Confidentiality. Gallagher reaffirms and agrees to observe and abide by the “Agreement Relating to Patents, Copyrights,Inventions, Confidentiality and Proprietary Information” entered into between Gallagher and the Company and any and allamendments and supplements thereto, and surviving Section 5 of the Employment Agreement (collectively, the “ConfidentialityAgreement”). For the avoidance of doubt, Confidential Information thereunder includes, without limitation, information or materialsregarding the Company’s plans, strategies, governance or operations, including any discussions or deliberations relating thereto.9. Trade Secrets and Confidential Information/Company Property/Inquiries. Gallagher’s signature below constitutes hisrepresentation that as of the Separation Date, he shall6(a) remove from any and all devices, records, files, folders, cameras, media, internet sites, electronic or digital devices, and any and allother sources, all documents, tapes, photographs, recordings, images, reproductions, electronic files, and other items provided toGallagher by the Company and/or any of the Releasees, developed or obtained by Gallagher in connection with his employment withthe Company, or otherwise belonging to the Company and/or any of the Releasees, and (b) return all documents, tapes, photographs,recordings, images, reproductions, electronic files, and other items provided to Gallagher by the Company, developed or obtained byGallagher in connection with his employment with the Company, or otherwise belonging to the Company, including but not limited toany personal computer(s), BlackBerry, iPhone, iPad, tapes, photographs, recordings, images, reproductions, electronic files, and otheritems. Gallagher further represents that he will not misuse or disclose any of the Company’s and/or any of the Releasees’ confidential,proprietary, or trade secret information to any third party other than a law enforcement or authorized regulatory agency of the UnitedStates Government or any state or local government. In addition, Gallagher will abide by the Company’s external communicationpolicy, such that in the event he receives any media, financial community or other third-party inquiries regarding the Company, exceptas provided in Section 10 of this Agreement, he will not respond (nor will he initiate any such contact) and will promptly notify theCompany’s Global Public Affairs Department at 724.514.1968 or gpa@mylan.com.10. Limits on Cooperation; Compliance. Gallagher agrees that he will not knowingly encourage, counsel, or assist anyattorneys or their clients in the presentation or prosecution of any disputes, differences, grievances, claims, charges, or complaints byany third party, other than a law enforcement or authorized regulatory agency of the United States Government or any state or localgovernment, against any of the Releasees. Gallagher may, however, respond to a lawful subpoena or other court order to do so or asrelated directly to the ADEA waiver in this Agreement or as otherwise required by law. Gallagher agrees both to promptly notify theCompany upon receipt of any such subpoena or court order, and to furnish, within three (3) business days of its receipt, a copy of suchsubpoena or other court order. If approached by anyone, other than a law enforcement or authorized regulatory agency of the UnitedStates Government or any state or local government, for counsel or assistance in the presentation or prosecution of any disputes,differences, grievances, claims, charges, or complaints against any of the Releasees, Gallagher shall state no more than that he cannotprovide counsel or assistance. If approached for counsel or assistance as aforementioned, whether by private parties or lawenforcement or regulatory agencies, Gallagher shall promptly notify the Company of such an occurrence, and provide information tothe Company regarding any such communication. While Gallagher may respond to inquiries by law enforcement or regulatoryagencies, Gallagher shall notify any such agencies of Gallagher’s obligations with respect to confidentiality under this Agreement, theConfidentiality Agreement, the Employment Agreement, and any other applicable agreements, and Gallagher shall continue to honorsuch obligations in the course of responding to law enforcement or regulatory agency inquiries, as lawfully permitted. Gallagherunderstands that nothing contained in this Agreement limits Gallagher's ability to file a charge or complaint with the Securities andExchange Commission (the “SEC”) pursuant to Section 21F of the Securities Exchange Act of 1934, as amended, limits Gallagher'sability to communicate with the SEC pursuant to such provision or limits Gallagher's right to receive an award for informationprovided to the SEC pursuant to such provision. Furthermore, Gallagher hereby7represents that he is not aware of any violation of any Company policy or the Company’s Code of Conduct in any event which couldcause harm (financial or otherwise) to any of the Mylan Companies (defined below) or their respective properties, shareholders,employees or prospects, other than matters which he has previously reported to the Office of Global Compliance or the Mylan LegalDepartment.Gallagher shall use his best efforts to cooperate with and respond to the Company’s reasonable requests for information orfollow-up assistance pertaining to work Gallagher performed on behalf of the Company and/or any subsidiary or affiliate, or othermatters in which Gallagher was involved or of which he was otherwise aware, prior to the Separation Date. Gallagher’s cooperationshall include without limitation Gallagher’s cooperation with requests of legal counsel for the Company and/or any subsidiary oraffiliate regarding any legal matters or proceedings of any kind currently pending or which may arise after the Separation Date.Gallagher’s cooperation shall include but not be limited to making himself available for interviews or testimony if reasonably requestedby the Company’s Legal or Compliance Departments. The Company will reimburse Gallagher for any expenses incurred by Gallagherin connection with such requests or assistance if approved by the Company’s Legal Department and supported by requireddocumentation. No payment made to Gallagher hereunder is intended to be or shall be interpreted as a payment for particular testimonyor assistance with respect to the legal matters specified above or any other matter. Gallagher understands that he is to provide his goodfaith assistance, and agrees to provide truthful responses to any requests for information or testimony.11. Non-Disparagement. Gallagher agrees to refrain from any disparaging statements, including but not limited to statementsthat amount to libel or slander, about the Company, its direct and indirect parents, subsidiaries or affiliated companies, and/or any of itsor their current or former employees, officers, or directors, and/or any of the other Releasees including, without limitation, the business,products, intellectual property, financial standing, future, or other employment, compensation, benefit, or personnel practices of theCompany and/or any of the Releasees. Gallagher further agrees to refrain from any disparaging statements, including but not limited tolibel or slander, about any of the Releasees that pertain to any personal or confidential matters that may cause embarrassment to any ofthe Releasees or may result in any adverse effect on the professional or personal reputation of any of the Releasees. The foregoingrestrictions shall not apply to any testimony that Gallagher is compelled by law to give (whether written or verbal). The Companyagrees to instruct its executive officers to refrain from any disparaging statements, including but not limited to libel or slander, aboutGallagher that pertain to any personal or confidential matters that may cause embarrassment to Gallagher or may result in any adverseeffect on the professional or personal reputation of Gallagher. The foregoing restrictions shall not apply to any testimony that anyexecutive officer of the Company is compelled by law to give (whether written or verbal).12. Breach.a. Material Breach of Agreement. In addition to the rights provided in Section 20 below, if Gallagher commits amaterial breach of this Agreement, which shall include8without limitation any breach of Sections 8, 9, 10 and 11 of this Agreement, and any breach of surviving Sections 5 (confidentiality)and 6 (noncompetition and nonsolicitation) of the Employment Agreement, the Company shall be entitled to cease providing thepayments and consideration provided to Gallagher under this Agreement (including, for the avoidance of doubt, canceling any equityawards Gallagher holds) and to obtain damages, except as provided by law.b. Gallagher also acknowledges and agrees that his compliance with Sections 8, 9, 10 and 11 of this Agreement andsurviving Sections 5 and 6 of the Employment Agreement is of the essence. The Parties agree that if the Company and/or any of theReleasees proves that Gallagher breached, intends to breach, or will breach any of these provisions (Sections 8, 9, 10 or 11 of thisAgreement or surviving Sections 5 or 6 of the Employment Agreement), without limiting any other remedies available to the Companyand/or any of the Releasees, the Company and/or any of the Releasees shall be entitled to an injunction restraining Gallagher from anyfuture or further breaches and an award of its costs spent enforcing the applicable provision(s), including all reasonable attorneys’ feesassociated with the enforcement action as provided in Section 20, without regard to whether the Company and/or any of the Releaseescan establish actual damages from Gallagher’s breach. Any such individual breach or disclosure shall not excuse Gallagher from hisobligations hereunder, nor permit him to make additional disclosures. Gallagher expressly agrees and warrants that he will not, inviolation of the terms of Sections 8, 9, 10 or 11 of this Agreement or surviving Section 5 of the Employment Agreement, disclose,orally or in writing, directly or indirectly, any of the Company’s confidential, proprietary or trade secret information to any third partyother than a law enforcement or authorized regulatory agency of the United States Government or any state or local government.Gallagher warrants that he has not encouraged or assisted any attorneys or their clients in the presentation or prosecution of anydisputes against the Company and/or any of the Releasees.13. No Admission of Liability/Compromise. No action taken by the Company and/or any of the Releasees, either previouslyor in connection with this Agreement, shall be deemed or construed to be (a) an admission of the truth or falsity of any actual orpotential claims or (b) an acknowledgment or admission by the Company and/or any of the Releasees of any fault or liability.14. Costs. The Parties shall each bear their own costs, attorneys’ fees, and other fees incurred in connection with thepreparation of this Agreement.15. Choice of Law and Forum. This Agreement shall be construed and enforced according to, and the rights and obligationsof the parties shall be governed in all respects by, the laws of the Commonwealth of Pennsylvania without reference to the principles ofconflicts of law thereof. Any controversy, dispute or claim arising out of or relating to this Agreement, or the breach hereof, including aclaim for injunctive relief, or any claim which, in any way arises out of or relates to, Gallagher’s employment with the Company orseparation from said employment (whether such dispute arises under any federal, state or local statute or regulation, or at common law),including but not limited to statutory claims for discrimination, shall be resolved by arbitration in accordance with the then current rulesof the American Arbitration Association respecting employment disputes pertaining at the time the dispute arises; provided, however,that9either party may seek an injunction in aid of arbitration with respect to enforcement of Sections 8, 9, 10 and/or 11 of this Agreementfrom any court of competent jurisdiction. The Parties agree that the hearing of any such dispute will be held in Pennsylvania. Thedecision of the arbitrator(s) will be final and binding on all parties and any award rendered shall be enforceable upon confirmation by acourt of competent jurisdiction. Any arbitration proceedings, decision or award rendered hereunder, and the validity, effect andinterpretation of this arbitration provision shall be governed by the Federal Arbitration Act, 9 U.S.C. § 1 et seq. Gallagher and theCompany expressly consent to the jurisdiction of any such arbitrator over them.16. Tax Consequences. The Company makes no representations or warranties with respect to the tax consequences of thepayments and any other consideration provided to Gallagher or made on his behalf under the terms of this Agreement. Gallagheragrees and understands that he is responsible for payment, if any, of local, state, and/or federal taxes on the payments and any otherconsideration provided hereunder by the Company and any penalties or assessments thereon. Gallagher further agrees to indemnifyand hold the Company harmless from any claims, demands, deficiencies, penalties, interest, assessments, executions, judgments, orrecoveries by any government agency against the Company for any amounts claimed due on account of (a) Gallagher’s failure to payor delayed payment of federal or state taxes, or (b) damages sustained by the Company by reason of any such claims, includingattorneys’ fees and costs.17. Authority. The Company represents and warrants that the undersigned has the authority to act on behalf of the Companyand to bind the Company and all who may claim through it to the terms and conditions of this Agreement. Gallagher represents andwarrants that he has the capacity to act on his own behalf and on behalf of all who might claim through him to bind them to the termsand conditions of this Agreement. Each Party warrants and represents that there are no liens or claims of lien or assignments in law orequity or otherwise of or against any of the claims or causes of action released herein.18. No Representations. Gallagher represents that he has had an opportunity to consult with an attorney and has carefully readand understands the scope and effect of the provisions of this Agreement. Gallagher has not relied upon any representations orstatements made by the Company that are not specifically set forth in this Agreement.19. Severability. In the event that any provision or any portion of any provision hereof or any surviving agreement made apart hereof becomes or is declared by a court of competent jurisdiction or arbitrator to be illegal, unenforceable, or void, thisAgreement shall continue in full force and effect without said provision or portion of provision.20. Attorneys’ Fees. Except with regard to a legal action challenging or seeking a determination in good faith of the validity ofthe waiver herein under the ADEA or otherwise prohibited by law, in the event that either Party brings an action to enforce or effect itsrights under this Agreement, the prevailing Party shall be entitled to recover its costs and expenses, including the costs of mediation,arbitration, litigation, court fees, and reasonable attorneys’ fees incurred in connection with such an action. Such costs and expensesshall be paid to the10prevailing party as soon as practicable after the legal action is resolved and in no event later than March 15 of the year followingresolution of the legal action.21. Entire Agreement. This Agreement, the surviving provisions of the Employment Agreement (i.e., Sections 5, 6, 7, 8, 10,11, 12, 13, 14, 15, 16, 17, 18, 19 and 20), and the Confidentiality Agreement represent the entire agreement and understandingbetween the Company and Gallagher concerning the subject matter of this Agreement and Gallagher’s employment with andseparation from the Company and the events leading thereto and associated therewith, and supersede and replace any and all priornegotiations, representations, agreements and understandings concerning the subject matter of such agreements, Gallagher’srelationship with the Company, and Gallagher’s obligations following employment with the Company. Gallagher acknowledges,reaffirms and agrees to observe and abide by all obligations that survive termination of the Employment Agreement.22. No Oral Modification. This Agreement may only be amended in a writing signed by Gallagher and the Company.23. Governing Law. The laws of the Commonwealth of Pennsylvania govern this Agreement, without regard for choice-of-law provisions. Gallagher consents to personal and exclusive jurisdiction and venue in the Commonwealth of Pennsylvania.24. Effective Date. Each Party has seven (7) days after that Party signs this Agreement to revoke it. This Agreement willbecome effective on the eighth (8th) day after Gallagher signed this Agreement, so long as it has been signed by the Parties and has notbeen revoked by either Party before that date (the “Effective Date”).25. Counterparts. This Agreement may be executed in counterparts and by facsimile, and each counterpart and facsimile shallhave the same force and effect as an original and shall constitute an effective, binding agreement on the part of each of theundersigned.26. Voluntary Execution of Agreement. Gallagher understands and agrees that he executed this Agreement voluntarily,without any duress or undue influence on the part or behalf of the Company and/or any of the Releasees or any third party, with thefull intent of releasing all of his claims against the Company and any of the other Releasees. Gallagher acknowledges that: (a) he hasread this Agreement; (b) he has been represented in the preparation, negotiation and execution of this Agreement by legal counsel ofhis own choice or has elected not to retain legal counsel; (c) he understands the terms and consequences of this Agreement and of thereleases it contains; (d) he is fully aware of the legal and binding effect of this Agreement and (e) he has been given the toll-freetelephone number of the Pennsylvania Bar Association to help him identify a qualified lawyer (800-692-7375).11IN WITNESS WHEREOF, the Parties have executed this Agreement on the respective dates set forth below.Dated: February 25, 2019By/s/ Daniel M. Gallagher Daniel M. Gallagher MYLAN INC.:Dated: February 25, 2019By/s/ Thomas D. Salus Name: Thomas D. SalusTitle: Assistant SecretarySchedule AOriginal Grant DateNumber of Restricted Stock UnitsMay 2, 20178,515May 12, 20178,218March 2, 201815,621A-1[3895348]Exhibit 10.34(b)EXECUTION VERSIONAMENDMENT TO REVOLVING CREDIT AGREEMENTAMENDMENT dated as of February 22, 2019 (this “Amendment”), to the Revolving Credit Agreement, dated as of July 27,2018 (as amended, supplemented or otherwise modified from time to time, the “Credit Agreement”), among MYLAN INC., aPennsylvania corporation (the “Borrower”), MYLAN N.V., a public limited liability company (naamloze vennootschap) incorporatedand existing under the laws of the Netherlands, with its corporate seat (statutaire zetel) in Amsterdam, the Netherlands and registeredwith the Dutch chamber of commerce under number 61036137 (“Parent” and a “Guarantor”), certain Affiliates and Subsidiaries ofParent from time to time party thereto as Guarantors, each Lender from time to time party thereto (the “Lenders”), each Issuing Bankfrom time to time party thereto and BANK OF AMERICA, N.A., as Administrative Agent (the “Agent”).W I T N E S S E T H : WHEREAS, the parties hereto desire to amend the Credit Agreement as set forth herein.NOW, THEREFORE, the parties hereto agree as follows:SECTION 1. Defined Terms; References. Unless otherwise specifically defined herein, each term used herein that is defined inthe Credit Agreement has the meaning assigned to such term in the Credit Agreement. Each reference to “hereof”, “hereunder”,“herein” and “hereby” and each other similar reference and each reference to “this Agreement” and each other similar referencecontained in the Credit Agreement shall, after this Amendment becomes effective pursuant to Section 6 hereof, refer to the CreditAgreement as amended hereby. This Amendment shall constitute a “Loan Document” for all purposes under the Credit Agreement.SECTION 2. Amendment to Credit Agreement. Subject to Section 6 hereof, Section 6.07 of the Credit Agreement is herebyamended and restated as follows:“Financial Covenant. The Parent will not permit the Consolidated Leverage Ratio as of the last day of any fiscal quarter (x)ended on or prior to December 31, 2019, to exceed 4.25 to 1.00 and (y) ended after December 31, 2019, to exceed 3.75 to1.00; provided that in lieu of the foregoing, for any such date occurring after a Qualified Acquisition, on or prior to the last dayof the third full fiscal quarter of the Parent after the consummation of such Qualified Acquisition, the Parent will not permit theConsolidated Leverage Ratio as of such date to exceed 4.25 to 1.00.”SECTION 3. Representations and Warranties of the Borrower and Parent. Each of the Borrower and Parent represents andwarrants that (i) as of the Amendment Effective Date (as defined below), the representations and warranties of the Borrower and Parentset forth in Article III of the Credit Agreement (other than Sections 3.04(b) and 3.06) will be true and correct in all material respectsexcept to the extent that such representations and warranties are expressly made as of a specific earlier date, in which case suchrepresentations and warranties are expressly made as of any such earlier date (as if each reference therein to a “Loan Document”included a reference to this Amendment); provided that, in each case, to the extent that any representation and warranty is qualified bymateriality, such representation and warranty shall be true and correct in all respects and (ii) no Default or Event of Default shall have occurred and be continuing immediately prior to giving effect to this Amendment and no Default or Event of Default will result fromthe execution, delivery and effectiveness of this Amendment.SECTION 4. Governing Law. This Amendment shall be construed in accordance with and governed by the law of the State ofNew York (without regard to the conflict of law principles thereof to the extent that the application of the laws of another jurisdictionwould be required thereby).SECTION 5. Counterparts. This Amendment may be signed in any number of counterparts, each of which shall be anoriginal, with the same effect as if the signatures thereto and hereto were upon the same instrument.SECTION 6. Effectiveness. (a) This Amendment shall become effective as of the date set forth above on the date (the“Amendment Effective Date”) when the Agent shall have received (i) from each of the Borrower, Parent and the Required Lenders acounterpart hereof signed by such party or facsimile or other written confirmation (in form satisfactory to the Agent) that such party hassigned a counterpart hereof and (ii) the fees previously agreed with the Borrower.(a) Except as expressly set forth herein, this Amendment shall not by implication or otherwise limit, impair, constitute awaiver of, or otherwise affect the rights and remedies of the Lenders, the Administrative Agent, any Guarantor or any other party underthe Credit Agreement or any other Loan Document, and shall not alter, modify, amend or in any way affect any of the terms,conditions, obligations, covenants or agreements contained in the Credit Agreement or any other Loan Document, all of which areratified and affirmed in all respects and shall continue in full force and effect. Article VIII and Section 9.03 of the Credit Agreementshall apply to the Agent’s role and responsibility in connection with this Amendment to the same extent as the Administrative Agentunder the Credit Agreement.(b) Nothing herein shall be deemed to entitle the Borrower, Parent or any Guarantor to a consent to, or a waiver,amendment, modification or other change of, any of the terms, conditions, obligations, covenants or agreements contained in the CreditAgreement or any other Loan Document in similar or different circumstances.[Signature Pages Follow]2 IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the date first abovewritten.MYLAN INC., as the BorrowerBy:/s/ John Miraglia Name:John Miraglia Title:TreasurerMYLAN N.V., as the Parent andGuarantorBy:/s/ John Miraglia Name:John Miraglia Title:Treasurer[Amendment to Revolving Credit Agreement — Signature Page] [[3892704]]BANK OF AMERICA, N.A., asAdministrative Agent By:/s/ Maurice E. Washington Name:Maurice E. Washington Title:Vice President[Amendment to Revolving Credit Agreement — Signature Page] BANK OF AMERICA, N.A.,individually as a Lender, as theSwingline Lender and as IssuingBank By:/s/ Yinghua Zhang Name:Yinghua Zhang Title:Director[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTBNP PARIBAS, as LenderLender NameBy:/s/ Michael Pearce Name:Michael Pearce Title:Managing DirectorFor Lenders that require an additional signature:By:/s/ Emma Petersen Name:Emma Petersen Title:Director[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTCITIBANK, N.A.Lender NameBy:/s/ Eugene Yermash Name:Eugene Yermash Title:Vice PresidentFor Lenders that require an additional signature:By: Name: Title: [Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTCOMMERZBANK AG, NEW YORK BRANCHLender NameBy:/s/ Mathew Ward Name:Mathew Ward Title:DirectorFor Lenders that require an additional signature:By:/s/ Veli-Matti Ahonen Name:Veli-Matti Ahonen Title:Vice President[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTDanske Bank A/SLender NameBy:/s/ Gert Carstens Name:Gert Carstens Title:Senior Loan ManagerFor Lenders that require an additional signature:By:/s/ Mereta Ryvald-Christensen Name:Mereta Ryvald-Christensen Title:Chief Loan Manager[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTDEUTSCHE BANK AG NEW YORK BRANCHLender NameBy:/s/ Ming K. Chu Name:Ming K. Chu Title:DirectorFor Lenders that require an additional signature:By:/s/ Virginia Cosenza Name:Virginia Cosenza Title:Vice President[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTDNB Capital LLCLender NameBy:/s/ Kristie Li Name:Kristie Li Title:Senior Vice PresidentFor Lenders that require an additional signature:By:/s/ Cathleen Buckley Name:Cathleen Buckley Title:Senior Vice President[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTGOLDMAN SACHS BANK USALender NameBy:/s/ Jamie Minieri Name:Jamie Minieri Title:Authorized Signatory[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTING BANK N.V., Dublin BranchLender NameBy:/s/ Sean Hassett Name:Sean Hassett Title:DiectorBy:/s/ Barry Fehily Name:Barry Fehily Title:Managing Director[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTJPMORGAN CHASE BANK, N.A.Lender NameBy:/s/ Deborah R. Winkler Name:Deborah R. Winkler Title:Executive DirectorFor Lenders that require an additional signature:By: Name: Title: [Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTMIZUHO BANK, LTD.Lender NameBy:/s/ Tracy Rahn Name:Tracy Rahn Title:Authorized SignatoryFor Lenders that require an additional signature:By: Name: Title: [Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTMorgan Stanley Bank, N.A.Lender NameBy:/s/ Jackson Eng Name:Jackson Eng Title:Authorized SignatoryFor Lenders that require an additional signature:By: Name: Title: [Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTMUFG BANK, LTD. (f.k.a. THE BANK OF TOKYO‑MITSUBISHI UFJ, LTD.)Lender NameBy:/s/ Jack Lonker Name:Jack Lonker Title:Director[Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTPNC BANK, NATIONAL ASSOCIATIONLender NameBy:/s/ Richard G. Tutich Name:Richard G. Tutich Title:Vice PresidentFor Lenders that require an additional signature:By: Name: Title: [Amendment to Revolving Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF JULY 27, 2018, AMONG MYLAN INC., AS BORROWER, MYLANN.V., AS PARENT AND GUARANTOR, THE GUARANTORS FROM TIME TO TIMEPARTY THERETO, THE SEVERAL BANKS AND OTHER FINANCIALINSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETO AND BANKOF AMERICA, N.A., AS ADMINISTRATIVE AGENTSKANDINAVISKA ENSKILDA BANKEN AB (PUBL)Lender NameBy:/s/ Penny Neville-Park Name:Penny Neville-Park Title: For Lenders that require an additional signature:By:/s/ Andrew Moore Name:Andrew Moore Title: [Amendment to Revolving Credit Agreement — Signature Page] GOLDMAN SACHS BANK USA, asIssuing Bank By:/s/ Jamie Minieri Name:Jamie Minieri Title:Authorized Signatory[Amendment to Revolving Credit Agreement — Signature Page] JPMORGAN CHASE BANK, N.A., asIssuing Bank By:/s/ Deborah R. Winkler Name:Deborah R. Winkler Title:Executive Director[Amendment to Revolving Credit Agreement — Signature Page] Exhibit 10.35(c)EXECUTION VERSIONAMENDMENT TO TERM CREDIT AGREEMENTAMENDMENT dated as of February 22, 2019 (this “Amendment”), to the Term Credit Agreement, dated as of November 22,2016 (as amended, supplemented or otherwise modified from time to time, the “Credit Agreement”), among MYLAN N.V., a publiclimited liability company (naamloze vennootschap) incorporated and existing under the laws of the Netherlands, with its corporate seat(statutaire zetel) in Amsterdam, the Netherlands and registered with the Dutch chamber of commerce under number 61036137 (the“Borrower”), certain Affiliates and Subsidiaries of the Borrower from time to time party thereto as Guarantors, each Lender from time totime party thereto (the “Lenders”) and GOLDMAN SACHS BANK USA, as Administrative Agent (the “Agent”).W I T N E S S E T H : WHEREAS, the parties hereto desire to amend the Credit Agreement as set forth herein.NOW, THEREFORE, the parties hereto agree as follows:SECTION 1. Defined Terms; References. Unless otherwise specifically defined herein, each term used herein that is defined inthe Credit Agreement has the meaning assigned to such term in the Credit Agreement. Each reference to “hereof”, “hereunder”,“herein” and “hereby” and each other similar reference and each reference to “this Agreement” and each other similar referencecontained in the Credit Agreement shall, after this Amendment becomes effective pursuant to Section 6 hereof, refer to the CreditAgreement as amended hereby. This Amendment shall constitute a “Loan Document” for all purposes under the Credit Agreement.SECTION 2. Amendment to Credit Agreement. Subject to Section 6 hereof, Section 6.07 of the Credit Agreement is herebyamended and restated as follows:“Financial Covenant. The Borrower will not permit the Consolidated Leverage Ratio as of the last day of any fiscal quarter (x)ended on or prior to December 31, 2019, to exceed 4.25 to 1.00 and (y) ended after December 31, 2019, to exceed 3.75 to1.00; provided that in lieu of the foregoing, for any such date occurring after a Qualified Acquisition, on or prior to the last dayof the third full fiscal quarter of the Borrower after the consummation of such Qualified Acquisition, the Borrower will notpermit the Consolidated Leverage Ratio as of such date to exceed 4.25 to 1.00.”SECTION 3. Representations and Warranties. The Borrower represents and warrants that (i) as of the Amendment EffectiveDate (as defined below), the representations and warranties of the Borrower set forth in Article III of the Credit Agreement (other thanSections 3.04(b) and 3.06) will be true and correct in all material respects except to the extent that such representations and warrantiesare expressly made as of a specific earlier date, in which case such representations and warranties are expressly made as of any suchearlier date (as if each reference therein to a “Loan Document” included a reference to this Amendment); provided that, in each case, tothe extent that any representation and warranty is qualified by materiality, such representation and warranty shall be true and correct inall respects and (ii) no Default or Event of Default shall have occurred and be continuing immediately prior to giving effect to this Amendment and no Default or Event of Default will result from the execution, delivery and effectiveness of thisAmendment.SECTION 4. Governing Law. This Amendment shall be construed in accordance with and governed by the law of the State ofNew York (without regard to the conflict of law principles thereof to the extent that the application of the laws of another jurisdictionwould be required thereby).SECTION 5. Counterparts. This Amendment may be signed in any number of counterparts, each of which shall be anoriginal, with the same effect as if the signatures thereto and hereto were upon the same instrument.SECTION 6. Effectiveness. (a) This Amendment shall become effective as of the date set forth above on the date (the“Amendment Effective Date”) when the Agent shall have received (i) from each of the Borrower, Mylan Inc. and the Required Lendersa counterpart hereof signed by such party or facsimile or other written confirmation (in form satisfactory to the Agent) that such partyhas signed a counterpart hereof and (ii) the fees previously agreed with the Borrower.(a) Except as expressly set forth herein, this Amendment shall not by implication or otherwise limit, impair, constitute awaiver of, or otherwise affect the rights and remedies of the Lenders, the Administrative Agent, any Guarantor or any other party underthe Credit Agreement or any other Loan Document, and shall not alter, modify, amend or in any way affect any of the terms,conditions, obligations, covenants or agreements contained in the Credit Agreement or any other Loan Document, all of which areratified and affirmed in all respects and shall continue in full force and effect. Article VIII and Section 9.03 of the Credit Agreementshall apply to the Agent’s role and responsibility in connection with this Amendment to the same extent as the Administrative Agentunder the Credit Agreement.(b) Nothing herein shall be deemed to entitle the Borrower or any Guarantor to a consent to, or a waiver, amendment,modification or other change of, any of the terms, conditions, obligations, covenants or agreements contained in the Credit Agreementor any other Loan Document in similar or different circumstances.SECTION 7. Direction. Each Lender party hereto hereby authorizes and directs the Agent to execute and deliver thisAmendment in its capacity as the Administrative Agent under the Credit Agreement.[Signature Pages Follow]2 IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed as of the date first abovewritten.MYLAN N.V., as BorrowerBy:/s/ John Miraglia Name:John Miraglia Title:TreasurerMYLAN INC., as GuarantorBy:/s/ John Miraglia Name:John Miraglia Title:Treasurer[Amendment to Term Credit Agreement — Signature Page] GOLDMAN SACHS BANK USA,individually as a Lender and asAdministrative Agent By:/s/ Douglas Tansey Name:Douglas Tansey Title:Authorized Signatory[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTBANK OF AMERICA, N.A.Lender NameBy:/s/ Yinghua Zhang Name:Yinghua Zhang Title:Director[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTBNP PARIBAS, as a LenderLender NameBy:/s/ Michael Pearce Name:Michael Pearce Title:Managing DirectorFor Lenders that require an additional signature:By:/s/ Emma Petersen Name:Emma Petersen Title:Director[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTCITIBANK, N.A.Lender NameBy:/s/ Eugene Yermash Name:Eugene Yermash Title:Vice PresidentFor Lenders that require an additional signature:By: Name: Title: [Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTCOMMERZBANK AG, NEW YORK BRANCHLender NameBy:/s/ Matthew Ward Name:Matthew Ward Title:DirectorFor Lenders that require an additional signature:By:/s/ Veli-Matti Ahonen Name:Veli-Matti Ahonen Title:Vice President[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTDanske Bank, A/SLender NameBy:/s/ Gert Carstens Name:Gert Carstens Title:Senior Loan ManagerFor Lenders that require an additional signature:By:/s/ Merete Ryvald-Christensen Name:Merete Ryvald-Christensen Title:Chief Loan Manager[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTDEUTSCHE BANK AG NEW YORK BRANCHLender NameBy:/s/ Ming K. Chu Name:Ming K. Chu Title:DirectorFor Lenders that require an additional signature:By:/s/ Virginia Cosenza Name:Virginia Cosenza Title:Vice President[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTDNB Capital LLCLender NameBy:/s/ Kristie Li Name:Kristie Li Title:Senior Vice PresidentFor Lenders that require an additional signature:By:/s/ Cathleen Buckley Name:Cathleen Buckley Title:Senior Vice President[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTING Bank, a Branch of ING-DiBa AGLender NameBy:/s/ Nikola Kopp Name:Nikola Kopp Title:DirectorFor Lenders that require an additional signature:By:/s/ W. Jansen Name:W. Jansen Title:Director[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTJPMORGAN CHASE BANK, N.A.Lender NameBy:/s/ Deborah R. Winkler Name:Doborah R. Winkler Title:Executive DirectorFor Lenders that require an additional signature:By: Name: Title: [Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTMIZUHO BANK, LTD.Lender NameBy:/s/ Tracy Rahn Name:Tracy Rahn Title:Authorized SignatoryFor Lenders that require an additional signature:By: Name: Title: [Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTMorgan Stanley Bank, N.A.Lender NameBy:/s/ Jackson Eng Name:Jackson Eng Title:Authorized SignatoryFor Lenders that require an additional signature:By: Name: Title: [Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTMUFG BANK, LTD. (f.k.a. THE BANK OF TOKYO-MITSUBISHI UFJ, LTD.)Lender NameBy:/s/ Jack Lonker Name:Jack Lonker Title:Director[Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTPNC BANK, NATIONAL ASSOCIATIONLender NameBy:/s/ Richard G. Tutich Name:Richard G. Tutich Title:Vice PresidentFor Lenders that require an additional signature:By: Name: Title: [Amendment to Term Credit Agreement — Signature Page] LENDER SIGNATURE PAGE TO THE AMENDMENT TO THE CREDIT AGREEMENTDATED AS OF NOVEMBER 22, 2016, AMONG MYLAN N.V., THE GUARANTORSFROM TIME TO TIME PARTY THERETO, THE SEVERAL BANKS AND OTHERFINANCIAL INSTITUTIONS OR ENTITIES FROM TIME TO TIME PARTY THERETOAND GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENTSKANDINAVISKA ENSKILDA BANKEN AB (PUBL)Lender NameBy:/s/ Penny Neville-Park Name:Penny Neville-Park Title: For Lenders that require an additional signature:By:/s/ Andrew Moore Name:Andrew Moore Title: [Amendment to Term Credit Agreement — Signature Page] Exhibit 21.1Subsidiaries as of December 31, 2018 NameState or Country of OrganizationAgila Australasia Pty LtdAustraliaAlphapharm Pty. Ltd.AustraliaMylan Australia Holding Pty LtdAustraliaMylan Australia Pty LimitedAustraliaMylan Health Pty. Ltd.AustraliaArcana Arzneimittel GmbHAustriaBGP Products GmbHAustriaMeda Pharma GmbHAustriaMeda Pharma S.A.BelgiumMylan BVBABelgiumMylan EPD BVBABelgiumMylan Bermuda Ltd.BermudaMylan d.o.o.Bosnia and HerzegovinaMeda Pharma Importação e Exportação de Produtos Farmacuticos Ltda.BrazilMylan Brasil Distribuidora de Medicamentos LtdaBrazilMylan Laboratórios LtdaBrazilMylan EOODBulgariaBGP Pharma ULCCanadaMeda Pharmaceuticals LtdCanadaMylan Pharmaceuticals ULCCanadaRottapharm Chile SAChileMeda Pharmaceutical Hong Kong Ltd.ChinaMedicine Meda Pharmaceutical Information Consultancy(Beijing) Co., LtdChinaMylan Pharmaceutical Science and Technology (Shanghai) Co., Ltd.ChinaMylan Hrvatska d.o.o.CroatiaOnco Laboratories LimitedCyprusBGP Products Czech Republic s.r.o.Czech RepublicMeda Pharma s.r.o.Czech RepublicMylan Pharmaceuticals s.r.o.Czech RepublicActon Pharmaceuticals, Inc.DelawareAlaven Pharmaceutical LLCDelawareALVP Holdings, LLCDelawareApicore Inc.DelawareApicore US LLCDelawareDelcor Asset CorporationDelawareDenco Asset, LLCDelawareDeogun Manufacturing, LLCDelawareDey Limited Partner LLCDelawareDey, Inc.DelawareEMD, Inc.DelawareEzio Pharma, Inc.DelawareFranklin Pharmaceutical LLCDelawareMadaus Inc.DelawareMarquis Industrial Company, LLCDelawareMeda Pharmaceuticals Inc.DelawareMylan Consumer Healthcare, Inc.DelawareMylan D.T. (U.S.) Holdings, Inc.DelawareMylan D.T. DPT Partner Sub, LLCDelawareMylan D.T., Inc.DelawareMylan Holdings Inc.DelawareMylan Institutional LLCDelawareMylan Investment Holdings 4 LLCDelawareMylan Investment Holdings 5 LLCDelawareMylan Investment Holdings 6 LLCDelawareMylan LLCDelawareMylan Securitization LLCDelawareMylan Special Investments LLCDelawareMylan Special Investments II, LLCDelawareMylan Special Investments III, LLCDelawareMylan Special Investments IV, LLCDelawareMylan Special Investments V, LLCDelawareMylan Special Investments VI, LLCDelawareMylan Specialty L.P.DelawareNimes, Inc.DelawarePowder Street, LLCDelawarePrestium Pharma, Inc.DelawareSomerset Pharmaceuticals, Inc.DelawareWallace Pharmaceuticals Inc.DelawareBGP Products ApSDenmarkMeda ASDenmarkMylan ApSDenmarkAgila Specialties UK LimitedEngland & WalesAgila Specialties Investments LimitedEngland & WalesGenerics [U.K.] Ltd.England & WalesMeda Pharmaceuticals LimitedEngland & WalesMylan Holdings Acquisition LimitedEngland & WalesMylan Holdings Acquisition 2 LimitedEngland & WalesMylan Holdings Ltd.England & WalesMylan Pharma UK LimitedEngland & WalesMylan Products LimitedEngland & WalesMylan UK Healthcare LimitedEngland & WalesMeda OyFinlandMylan Finland OYFinlandMylan OYFinlandLaboratoires Madaus SASFranceMeda Holding S.A.S.FranceMeda Manufacturing S.A.S.FranceMeda Pharma S.A.S.FranceMylan EMEA S.A.S.FranceMylan Generics France Holding S.A.S.FranceMylan Laboratories SASFranceMylan Medical SASFranceMylan S.A.S.FranceRottapharm SASFranceErste Madaus Beteiligungs GmbHGermanyMadaus GmbHGermanyMeda Germany Beteiligungs GmbHGermanyMeda Germany Holding GmbHGermanyMeda Manufacturing GmbHGermanyMeda Pharma Gmbh & Co KGGermanyMylan Germany GmbHGermanyMWB Pharma GmbHGermanyMylan dura GmbHGermanyMylan Healthcare GmbHGermanyPharmazeutische Union GmbHGermanyPharmLog Pharma Logistik GmbHGermanyTropon U-Kasse GmbHGermanyViatris GmbHGermanyRottapharm Madaus GmbHGermanyZweite Madaus Beteiligungs GmbHGermanyMylan (Gibraltar) 4 LimitedGibraltarMylan (Gibraltar) 5 LimitedGibraltarMylan (Gibraltar) 6 LimitedGibraltarMylan (Gibraltar) 7 LimitedGibraltarMylan (Gibraltar) 8 LimitedGibraltarMylan (Gibraltar) 9 LimitedGibraltarBGP Pharmaceutical Products Ltd.GreeceGenerics Pharma Hellas E.P.E.GreeceMeda Pharmaceuticals S.A.GreeceMeda Pharma Hungary KereskedelmiHungaryMylan EPD KftHungaryMylan Hungary Kft.HungaryMylan KftHungaryMylan Institutional Inc.IllinoisMadaus Pharmaceuticals Private LimitedIndiaMylan Laboratories India Private LimitedIndiaMylan Laboratories LimitedIndiaMylan Pharmaceuticals Private LimitedIndiaBGP Products LimitedIrelandMcDermott Laboratories LimitedIrelandMeda Health Sales Ireland LimitedIrelandMylan Investments LimitedIrelandMylan IRE Healthcare LimitedIrelandMylan Ireland Holdings LimitedIrelandMylan Ireland Investment Designated Activity CompanyIrelandMylan Ireland LimitedIrelandMylan Pharma Acquisition LimitedIrelandMylan Pharma Group LimitedIrelandMylan Pharma Holdings LimitedIrelandMylan TeorantaIrelandRottapharm LimitedIrelandMylan Italia S.r.L.ItalyDermogroup SrlItalyMadaus SrlItalyMeda Pharma SpAItalyMylan S.p.A.ItalyRottapharm SpAItalyMylan EPD G.K.JapanMylan Seiyaku Ltd.JapanSIA "BGP Products"LatviaSIA Meda PharmaLatviaBGP Products UABLithuaniaBGP Products S.à.r.l.LuxembourgIntegral SALuxembourgMeda Pharma SarlLuxembourgMylan Luxembourg 1 S.à r.l.LuxembourgMylan Luxembourg 2 S.à r.l.LuxembourgMylan Luxembourg 3 S.à r.l.LuxembourgMylan Luxembourg 6 S.à r.l.LuxembourgMylan Luxembourg 7 S.à r.l.LuxembourgMylan Luxembourg 9 S.à r.l.LuxembourgMylan Luxembourg S.à r.l.LuxembourgSIM S.A.LuxembourgMylan Healthcare Sdn. Bhd.MalaysiaMylan Malaysia SDN. BHD.MalaysiaMP Laboratories (Mauritius) Ltd.MauritiusMeda Phama, S. de R.L. de C.V.MexicoMeda Pharma Servicios, S. de R.L. de C.V.MexicoMylan Pharmaceuticals S.A.S.MoroccoMylan Healthcare B.V.NetherlandsMeda Pharma B.V.NetherlandsMylan B.V.NetherlandsMylan Group B.V.NetherlandsAgila Specialties Inc.New JerseyMylan New Zealand LimitedNew ZealandMylan Health Management LLCNorth CarolinaMeda ASNorwayMylan Healthcare Norge ASNorwayMylan Hospital ASNorwayZpearPoint ASNorwayMLRE LLCPennsylvaniaMylan Holdings Sub Inc.PennsylvaniaMylan Inc.PennsylvaniaSynerx Pharma, LLCPennsylvaniaMylan Philippines Inc.PhilippinesMylan EPD Sp. Z o.o.PolandMylan Healthcare S.p. Z o.o.PolandMylan Pharmaceuticals Sp. Z o.o.PolandBGP Products, Unipessoal, LDAPortugalLaboratorios Anova - Produtos Farmaceuticos, LDAPortugalLaboratorios Delta SAPortugalMeda Pharma Produtos Farmaceuticos SAPortugalMylan EPD Lda.PortugalMylan, Lda.PortugalBGP Products S.r.l.RomaniaMeda Pharma OOORussian FederationMylan Pharmaceuticals Pte Ltd.SingaporeBGP Products s.r.o.SlovakiaMeda Pharma spol. s.r.o.SlovakiaMylan s.r.o.SlovakiaGSP Proizvodi, farmacevtska druzba, d.o.o.SloveniaMylan, farmacevtska druzba, d.o.o.SloveniaMeda Pharma South Africa (Pty) LimitedSouth AfricaMylan (Proprietary) LimitedSouth AfricaSCP Pharmaceuticals (Proprietary) LimitedSouth AfricaXixia Pharmaceuticals (Proprietary) LimitedSouth AfricaMeda Pharma, S.L.SpainMylan Pharmaceuticals S.L.SpainAbbex ABSwedenAntula Holding ABSwedenBGP Products ABSwedenEllem Lakemedel ABSwedenIpex ABSwedenIpex Medical ABSwedenMeda ABSwedenMeda OTC ABSwedenMylan ABSwedenMylan Sweden Holdings ABSwedenRecip ABSwedenRecip Lakemedel ABSwedenSafe Breath International ABSwedenScandinavian Pharmaceuticals-Generics AB (SE)SwedenScandpharm Marketing ABSwedenMylan Pharma GmbHSwitzerlandBGP Products Operations GmbHSwitzerlandBGP Products Switzerland GmbHSwitzerlandMeda Pharma GmbH (Switzerland)SwitzerlandMeda Pharmaceuticals Switzerland GmbHSwitzerlandMylan GmbHSwitzerlandMylan Holdings GmbHSwitzerlandMylan (Taiwan) LimitedTaiwan Province of ChinaDPT Laboratories, Ltd.TexasMylan Bertek Pharmaceuticals Inc.TexasMeda Pharma (Thailand) Co., Ltd.ThailandMeda Pharma Ilac San ve Tic Ltd. StiTurkeyMeda Pharmaceuticals MEA FZ-LLCUnited Arab EmiratesMylan FZ-LLCUnited Arab EmiratesAmerican Triumvirate Insurance CompanyVermontMylan International Holdings, Inc.VermontMP AIR, INC.West VirginiaMylan Pharmaceuticals Inc.West VirginiaMylan Technologies, Inc.West VirginiaMylan ASI LLCWyomingEXHIBIT 23CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMWe consent to the incorporation by reference in Registration Statement No. 333-206912 on Form S-8, and Registration Statement No. 333-206913 on FormS-3, of our reports dated February 26, 2019, relating to the consolidated financial statements of Mylan N.V. and subsidiaries (the “Company”) and theeffectiveness of the Company’s internal control over financial reporting, appearing in this Annual Report on Form 10-K of Mylan N.V. for the year endedDecember 31, 2018./s/ DELOITTE & TOUCHE LLPPittsburgh, PennsylvaniaFebruary 26, 2019EXHIBIT 31.1Certification of Principal Executive Officer Pursuant toSection 302 of the Sarbanes-Oxley Act of 2002I, Heather Bresch, certify that:1.I have reviewed this Form 10-K of Mylan N.V.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respectsthe financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as definedin Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) forthe registrant and have:a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by otherswithin those entities, particularly during the period in which this report is being prepared;b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed underour supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles;c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions aboutthe effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andd)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’smost recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’sinternal control over financial reporting. /s/ Heather Bresch Heather Bresch Chief Executive Officer (Principal Executive Officer)Date: February 26, 2019EXHIBIT 31.2Certification of Principal Financial Officer Pursuant toSection 302 of the Sarbanes-Oxley Act of 2002I, Kenneth S. Parks, certify that:1.I have reviewed this Form 10-K of Mylan N.V.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respectsthe financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as definedin Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) forthe registrant and have:a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under oursupervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by otherswithin those entities, particularly during the period in which this report is being prepared;b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed underour supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles;c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; andd)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; andb)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting. /s/ KENNETH S. PARKS Kenneth S. Parks Chief Financial Officer (Principal Financial Officer)Date: February 26, 2019EXHIBIT 32CERTIFICATIONS OF PRINCIPAL EXECUTIVE OFFICER ANDPRINCIPAL FINANCIAL OFFICERPURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Form 10-K of Mylan N.V. (the “Company”) for the year ended December 31, 2018 as filed with the Securities and ExchangeCommission on the date hereof (the “Report”), each of the undersigned, in the capacities and on the date indicated below, hereby certifies pursuant to18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:1.The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and2.The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany.Date: February 26, 2019 /s/ HEATHER BRESCH Heather BreschChief Executive Officer(Principal Executive Officer) /s/ KENNETH S. PARKS Kenneth S. ParksChief Financial Officer(Principal Financial Officer)A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company andfurnished to the Securities and Exchange Commission or its staff upon request.The foregoing certification is being furnished in accordance with Securities and Exchange Commission Release No. 34-47551 and shall not beconsidered filed as part of the Form 10-K.

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