Oxford Immunotec Global PLC
Annual Report 2018

Plain-text annual report

Table of ContentsUNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2018 OR ☐☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from to Commission File Number 001-36200 OXFORD IMMUNOTEC GLOBAL PLC (Exact name of registrant as specified in its charter) England and Wales 98-1133710(State or Other Jurisdiction ofIncorporation or Organization) (I.R.S. EmployerIdentification No.) 94C Innovation Drive, Milton Park, Abingdon OX14 4RZ, UnitedKingdom Not Applicable(Address of Principal Executive Offices) (Zip Code)+44 (0)1235 442780 (Registrant’s Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registeredOrdinary Shares, £0.006705 nominal value per share The NASDAQ Global Market Securities registered pursuant to Section 12(g) of the ActNone Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒ Indicate 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 1934during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filingrequirements for the past 90 days. Yes ☒ No ☐ Table of Contents Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to thebest of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment tothis Form 10-K. ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growthcompany” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐Accelerated filer ☒Smaller reporting company ☐ Non-accelerated filer ☐ 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 newor revised financial accounting 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 Exchange Act). Yes ☐ No ☒ As of March 1, 2019, there were 26,617,311 Ordinary Shares, nominal value £0.006705, of Oxford Immunotec Global PLC outstanding. As of June 30, 2018, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’sOrdinary Shares held by non-affiliates was approximately $283,039,200.DOCUMENTS INCORPORATED BY REFERENCE The following documents (or parts thereof) are incorporated by reference into the following parts of this Form 10-K: Certain information required by PartIII of this Annual Report on Form 10-K is incorporated from our definitive proxy statement pursuant to Regulation 14A, to be filed with the Commissionnot later than 120 days after the close of our fiscal year ended December 31, 2018. Table of Contents Special Note Regarding Forward-Looking Statements This Annual Report on Form 10-K, and exhibits hereto, contains or incorporates by reference estimates, predictions, opinions, projections and otherstatements that may be interpreted as “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, asamended, or the Exchange Act. The forward-looking statements are contained principally in Part I, Item 1: “Business,” Part I, Item 1A: “Risk Factors,” andPart II, Item 7: “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in thisAnnual Report. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “would,” “could,” “should,” “intend,”“plan,” “contemplate,” “expect,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “target,” “potential,” “continue,” and “ongoing” and othercomparable expressions intended to identify statements about the future, although not all forward-looking statements contain these identifying words.These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, level of activity,performance or achievements to differ materially from those currently anticipated. Forward-looking statements are neither historical facts nor assurances offuture performance. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we cautionyou that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannotbe certain and that involve substantial risks and uncertainties. Such risks and uncertainties include, but are not limited to: ●our failure to meet our obligations arising from the sale of our U.S. laboratory services business, or the U.S. Laboratory Services Business, withQuest Diagnostics Incorporated, or Quest, a Delaware corporation, or the Transaction; ●the potential disruption of management time from ongoing business operations due to the Transaction; ●our exposure to potential litigation and contingent liabilities pursuant to the Transaction that could have a material adverse effect on ourfinancial condition; ●our history of losses, our ability to achieve or sustain profitability and our ability to manage our growth; ●our ability to effectively use our current financial resources and our ability to obtain additional capital resources; ●our ability to further develop, commercialize and achieve market acceptance of our current and future products; ●our ability to obtain and maintain regulatory body clearance and approval to market any of our products; ●continued demand for diagnostic products for tuberculosis, tick-borne diseases and other than immune-regulated conditions and thedevelopment of new market opportunities; ●our ability to compete successfully and to maintain and expand our sales network; ●coverage and reimbursement decisions of third-party payors, as well as guidelines, recommendations, and studies published by variousorganizations related to the use of our products; ●decisions by insurers and other third party payors with respect to coverage and reimbursement for our products; ●our dependence on certain of our customers, suppliers and service providers; ●disruptions to our business, including disruptions at our laboratories and manufacturing facilities; ●the integrity and uninterrupted operation of our information technology and storage systems; ●the impact of currency fluctuations on our business; ●the impact of global economic and political developments, including the referendum to leave the European Union, passed by the UnitedKingdom, or U.K., on June 23, 2016, and further implementing legislation on our business; ●potential changes in the United States, or U.S., social, political, regulatory and economic conditions or laws and policies governing the healthcare system, U.S. tax laws, foreign trade, immigration, manufacturing, and development and investment in the territories and countries where weor our customers and suppliers operate; ●our ability to make successful acquisitions or investments and to manage the integration of such acquisitions or investments; ●our ability to retain key members of our management; ●the impact of taxes on our business, including our ability to use net operating losses; ●the impact of legislative and regulatory developments, including healthcare and tax reform, on our business; ●the impact of product liability, intellectual property and commercial litigation on our business; ●our ability to comply with Securities and Exchange Commission, or SEC, reporting, antifraud, anti-corruption, environmental, health and safetylaws and regulations; ●our ability to maintain our licenses to sell our products around the world, including in countries such as China and the U.S. and in the severalU.S. states requiring licensure; Table of Contents ●our ability to protect and enforce our intellectual property rights; ●our status as an English company listing ordinary shares in the U.S.; ●the volatility of the price of our ordinary shares, including the risk the Transaction could have adverse effects on the market price of our ordinaryshares, substantial future sales of our ordinary shares and the fact that we do not pay dividends; and ●the impact of anti-takeover provisions under U.K. law and our articles of association. You should refer to Item 1A, “Risk Factors” in this Annual Report for a discussion of other important factors that may cause our actual results to differmaterially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-lookingstatements in this Annual Report will prove to be accurate. Further, if our forward-looking statements prove to be inaccurate, the inaccuracy may bematerial. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation orwarranty by us that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this Annual Reportrepresent our views only as of the date of this Annual Report. Subsequent events and developments may cause our views to change. While we may elect toupdate these forward-looking statements at some point in the future, we undertake no obligation to publicly update any forward-looking statements,except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to thedate of this Annual Report. As used in this Annual Report, the words “Company,” “we,” “us” and “our” refer to Oxford Immunotec Global PLC, a publiclimited company incorporated under the laws of England and Wales. Table of Contents Table of Contents Page PART I Item 1.Business1 Item 1A.Risk Factors12 Item 1B.Unresolved Staff Comments32 Item 2.Properties32 Item 3.Legal Proceedings32 Item 4.Mine Safety Disclosures32 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities33 Item 6.Selected Consolidated Financial Data35 Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations37 Item 7A.Quantitative and Qualitative Disclosures About Market Risk55 Item 8.Financial Statements and Supplementary Data55 Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure57 Item 9A.Controls and Procedures57 Item 9B.Other Information57 PART III Item 10.Directors, Executive Officers and Corporate Governance58 Item 11.Executive Compensation58 Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters58 Item 13.Certain Relationships and Related Transactions, and Director Independence58 Item 14.Principal Accounting Fees and Services58 PART IV Item 15.Exhibits, Financial Statement Schedules59 Item 16.Form 10-K Summary62 Signatures63 Table of Contents Part I Item 1. Business Overview We are a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for immunology and infectious diseaseby leveraging the technological, product development, manufacturing, quality, regulatory, and sales and marketing capabilities we have developed overour sixteen year history. Our proprietary T-SPOT®1.TB test utilizes our T-SPOT technology platform to test for tuberculosis, which is the leading cause ofinfectious disease death worldwide. On November 6, 2018, we completed the sale of our U.S. Laboratory Services Business to Quest, for gross proceeds of $170 million in cash. ThisTransaction represented a strategic business shift and it had a major effect on our operations and financial results. Following the Transaction, we haveapproximately 210 employees, including sales and marketing teams on three continents, and a laboratory in the United Kingdom. Our T-SPOT.TB test Tuberculosis is a common and, if not properly treated, potentially lethal infectious disease caused by the bacterium Mycobacterium tuberculosis, or MTB.MTB typically infects the lungs, but the lymph nodes, kidneys, brain and bones may also be infected. Those with latent tuberculosis infection, or LTBI,are asymptomatic and are not infectious; however, each person with LTBI has a 5% to 10% chance, on average, of progressing to active TB over his or herlifetime. This risk of progression to active TB is significantly elevated among individuals with weakened immune systems, such as those with humanimmunodeficiency virus, or HIV, or diabetes or those on drugs that suppress the immune system (e.g., those taking biologic therapies for autoimmunedisease or those undergoing immune suppression post-transplantation). Without proper treatment, up to two thirds of individuals with active TB diseasewill die. According to the World Health Organization, or the WHO, approximately 23% of the world’s population, or about 1.7 billion people, are infected with M.tuberculosis. Despite the availability of an effective treatment, TB is the leading cause of infectious disease death worldwide and remains one of the topten causes of death worldwide from any cause. The WHO estimated that in 2017 approximately 10 million people developed TB disease, of whichapproximately 1.6 million people died. There are three broad strategies to control TB: vaccination, finding and treating active TB disease, and finding and treating LTBI to prevent thedevelopment of new active TB disease cases. The United States has one of the most comprehensive LTBI screening programs in the world with screeningof several high-risk groups, including healthcare workers, recommended by the U.S. Centers for Disease Control and Prevention, or the CDC. Screening ofhealthcare workers is also recommended as part of the accreditation standards for U.S. hospitals. Other high-risk groups identified by CDC include personswith immunosuppressive conditions, such as persons receiving immunosuppressive agents or organ transplant recipients, and persons with humanimmunodeficiency virus, or HIV. In addition, TB screening is required in many cases for additional populations, such as day care staff, school teachers andstudents, and emergency response personnel. We estimate that there are approximately 22 million LTBI tests performed each year in the United States, the majority of which are performed within thehealthcare system in a variety of settings, including hospitals, public health offices, physicians’ offices and clinics. Outside the United States, we estimatethe total number of tests exceeds 28 million each year, for a combined market size of over 50 million LTBI tests annually. The primary test currently used for TB screening is the more than 100-year-old TST. The TST is administered by injecting an extract from cultured M.tuberculosis, called tuberculin or PPD, into the skin of a subject’s forearm using a needle and syringe. The injection of the PPD into the skin of a subjectpreviously infected with MTB stimulates the immune response, including T cells, causing the formation of a hard lump at the site of the injection.Because it takes time for this reaction to occur, the subject must return 48 to 72 hours after the PPD injection to have the result read. The test result isgraded by feeling for the boundaries of the swelling, marking these with a pen and then measuring the diameter with a ruler. The TST suffers from several limitations, including an antiquated technique that results in substantial test variability, false negative results inimmunocompromised patients, false positive results in patients who have been Bacille Calmette-Geurin, or BCG, vaccinated and boosting of results,which occurs when an infected subject’s reaction to an initially false-negative TST causes increased sensitivity in a subsequent test such that it testspositive. In addition to these technical drawbacks, the TST requires multiple patient visits, which increases its overall cost. 1“T-SPOT®,” “T-Cell Xtend®,” “Oxford Diagnostic Laboratories®,” “ODL®,” “Immunetics®,” the Oxford Immunotec logo, our laboratory logo andother marks are our trademarks. Solely for convenience, trademarks and trade names referred to in this Annual Report on Form 10-K, including logos,artwork and other visual displays, may appear without the® or ™ symbols, but such references are not intended to indicate in any way that we will notassert, to the fullest extent under applicable law, our rights to these trademarks and trade names. 1Table of Contents Our T-SPOT.TB test addresses the limitations of the TST by directly measuring antigen-specific T cells indicative of TB infection. We use two TB-specificantigens, ESAT-6 and CFP10, to stimulate T cells that have previously been exposed to MTB, which causes them to release a cytokine called interferon-gamma. Interferon-gamma is one of the dominant cytokines released by activated T cells when encountering MTB. In contrast to the PPD reagent used inthe TST, these two antigens are not shared with the BCG vaccine or with most non-tuberculous mycobacteria. Because our test detects individual T cellsvia their release of interferon-gamma, our test is sometimes referred to generically as an IGRA. Our proprietary T-SPOT.TB test leverages our T-SPOT technology platform, which allows us to measure the response of specific immune cells to informthe diagnosis, prognosis and monitoring of patients with immune-regulated conditions. Our T-SPOT.TB test has been approved for sale in over 50countries, including the United States, where we have received premarket approval, or PMA, from the Food and Drug Administration, or FDA, in Europe,where we have obtained a CE mark, as well as in Japan and China. An interferon-gamma release assay, or IGRA, such as our T-SPOT.TB test has beenincluded in clinical guidelines for TB testing in over 30 countries, including the United States, several European countries, China and Japan. In addition,we have established reimbursement for our test in the United States, as well as a Current Procedural Terminology, or CPT, code that is unique to our test.Outside the United States, we have established reimbursement in several countries where reimbursement applies, including Japan, Switzerland, Germany,France and South Korea. We have also established the cost-effectiveness of our test in several published studies. We believe the annual global marketopportunity for our T-SPOT.TB test is well in excess of $1 billion, assuming we can largely displace the tuberculin skin test, or TST, in the developedworld. Our T-SPOT.TB commercialization strategy We currently offer our T-SPOT.TB test as an in vitro diagnostic kit globally, meaning we sell test kits and associated accessories to laboratories thatperform the testing themselves. We have also established a clinical testing laboratory in the United Kingdom, where we perform our T-SPOT.TB test onsamples sent to us by customers. We market our service offering under the name Oxford Diagnostic Laboratories®, or ODL®. Our test is widely reimbursed both internationally, with reimbursement established in Japan, Switzerland, Germany, France and South Korea, and in theU.S., where we have established a unique CPT code for our test. We believe that clinical guidelines, which are recommendations issued by national medical societies or public health bodies, are a driving factor in aclinician’s decision to use a specific diagnostic test. IGRAs, such as our T-SPOT.TB test have been included in clinical guidelines for TB testing in over30 countries, including the United States, several European countries, China and Japan. In recent years, the use of IGRAs has been increasinglyrecommended and our sales and marketing activities will continue to look to exploit these increasingly positive guidelines updates. ●In December 2016, a publication titled “Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Controland Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children” recommended use of IGRAs for testing for TBinfection instead of the TST for patients over the age of five who meet the following criteria: 1) are likely to be infected with MTB, 2) have a lowor intermediate risk of disease progression, 3) testing for LTBI is warranted, and 4) either have a history of BCG vaccination or are unlikely toreturn for a second visit to read the TST. ●In February 2018, the CDC issued a notification informing the United States Citizenship and Immigration Services that a revised tuberculosistechnical instruction would go into effect on October 1, 2018. As of the effective date, when a test for cell-mediated immunity to TB is required,all civil surgeons must use an FDA-approved IGRA test; performing a skin test is no longer allowed. ●In June 2018, updated guidelines from the American Academy of Pediatrics, or AAP, were published in the AAP’s 2018 Red Book: Report of theCommittee on Infectious Diseases, or the Red Book. The Red Book contains a composite summary of current recommendations representing thepolicy of the AAP on various aspects of infectious diseases and is issued every three years. ●The AAP guidelines include specific recommendations for the use of IGRAs, such as our T-SPOT.TB test, and the recommended age for IGRA usewas lowered from five years to two years in these updated guidelines. ●In May 2018, IGRAs, of which our T-SPOT.TB test is one of two available globally, were included in the World Health Organization’s first everList of Essential In Vitro Diagnostics (EDL). The EDL includes the 113 most important tests recommended by the WHO for use at various levelsof the health care system. These essential diagnostics satisfy the priority health care needs of the population and were selected with due regard todisease prevalence and public health relevance, evidence of efficacy and accuracy, and comparative cost-effectiveness. 58 of the tests listed arefor the detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening andmanagement of patients. The remaining 55 tests are designed for the detection, diagnosis, and monitoring of WHO key disease areas, for whichthere is high quality evidence – HIV, tuberculosis (TB), malaria, hepatitis B and C, syphilis and human papilloma virus. 2Table of Contents We believe that these guidelines, and similar national guidelines outside the United States in countries such as China, allow us to access the vast majorityof the current TST market and assert the superiority of an IGRA in significant segments of the market. We currently market our T-SPOT.TB test directly in the United States, Northern Europe and Japan. Outside of these territories, we have contracted withdistributors who market and sell our test. In countries where we have a direct presence, we use a combination of sales managers, sales representatives,customer service staff and technical experts to interact with clinicians, nurses, administrative staff, laboratories and other groups who are involved in theimplementation of TB screening programs. Our goal is to educate these groups about the clinical, operational and economic benefits of switching from theTST to our T-SPOT.TB test. Our customer service staff and technical experts are also involved in the practical training of customers to perform and orderour T-SPOT.TB test as well as providing ongoing customer support. In addition to these teams, we offer a diverse array of marketing programs and services,which include advertising, medical education, attendance at scientific meetings and other awareness-raising activities. We have been investing in product development initiatives that we believe will increase use of T-SPOT.TB by new and existing customers, enable TBtesting in new locations and create more formidable barriers to entry within the LTBI testing market long-term. For example, in April 2018, we obtained aCE mark for the T-Cell SelectTM kit, which can be used to isolate mononuclear immune cells using positive selection via a magnetic bead cell separationsystem. Expected benefits of T-Cell Select include simplified workflow, improved throughput, reduced hands-on time and reduced labor costs inperforming T-SPOT.TB. Furthermore, with T-Cell Select, blood samples can be collected in a single standard blood tube and stored for up to 54 hours atroom temperature before use in the test, further extending our simplicity and logistics advantages for customers. We also have a number of capabilities that we believe we can leverage in developing and commercializing products. We have a proven track record ofrunning multi-center clinical trials, changing guidelines and establishing reimbursement, capabilities that are important to commercial success ofdiagnostic products. We have the experience and capability to gain regulatory clearance to manufacture and sell products meeting the regulatoryrequirements of numerous countries around the world. This, combined with our global sales and marketing infrastructure, which includes sales andmarketing teams on three continents, and a laboratory in the United Kingdom allows us to generate revenues in a large number of countries. Our currentcustomer base includes hospitals, commercial testing laboratories, importers and distributors. T-SPOT.TB regulatory approvals and clinical validation Our T-SPOT.TB test is approved for commercial sale in over 50 countries. Key geographies where we have regulatory approval include: ●The United States. We obtained PMA for our T-SPOT.TB test from the FDA in 2008. Since 2008, an additional ten PMA supplements have beenapproved, including supplements relating to manufacturing improvements and label extensions, such as those that enable overnight shipment ofblood samples. ●Europe. We obtained a CE mark in 2004, which allows us to sell our T-SPOT.TB test in Europe as well as other countries that accept the CE mark. ●China. We obtained initial approval for our T-SPOT.TB test from the China Food and Drug Administration, or the CFDA, in 2010. Consistentwith CFDA re-registration requirements, we secured re-registration of our test in 2014, which will remain effective until November 2019. ●Japan. We obtained approval for our T-SPOT.TB test from the Ministry of Health, Labour and Welfare, or MHLW, in 2012. In addition to being validated in multiple clinical studies, our T-SPOT.TB test has also been the subject of nearly 500 peer-reviewed publications inscientific journals including several meta-analyses. In April 2018, we declared conformity enabling us to attach the CE mark for the T-Cell Select kit, which can be used to isolate mononuclear immune cellsusing positive selection via a magnetic bead cell separation system. In December 2018, we obtained acceptance of the regulatory notification for the T-Cell Select kit by the CFDA. Our T-SPOT technology platform The human immune system is composed of two principal branches: cellular (T cell) immunity and humoral (B cell and antibody-based) immunity.Through our T-SPOT technology platform we can efficiently measure marker-specific T cell responses at a single cell level and thereby inform thediagnosis, prognosis and monitoring of patients with immune-regulated conditions. We believe these areas are attractive because they involve largepatient populations and chronic conditions that present the opportunity for both initial diagnosis and additional testing to monitor the conditions. We employ a quantitative method to detect antigen-specific cells releasing immune messenger molecules, called cytokines, released by effector T cells. Inrelation to effector T cells, our technology is designed to selectively measure responses from this subtype of T cells because they are primarily presentwhen active, replicating pathogens are inside the body, as opposed to other T cell subtypes that may be present long after an infection has been clearedfrom the body. For diagnosis and monitoring applications, it is more relevant to be able to measure the immune response associated with the currentinfection rather than the immune response associated only with past, cleared exposure. 3Table of Contents Our T-SPOT technology offers many technical advantages including high analytical sensitivity, potential application across multiple diseases andconditions and standardization of white blood cell counts, which makes our technology particularly useful in immunocompromised patients, such asthose undergoing transplant surgery or immunosuppressive therapy. We employ proprietary manufacturing processes and protocols designed to cost-effectively and reliably produce key elements of our T-SPOT technology, including the process for coating microtiter plates with cytokine antibodies,such as IFN-y antibodies, and our quality control testing procedures. Competitive landscape Our T-SPOT.TB test competes primarily with the TST. We believe our T-SPOT.TB test has a number of compelling advantages that make it a superioralternative to the more than 100-year-old TST, including superior sensitivity and specificity, simplicity of administration and elimination of variabilitydue to subjective interpretation of results. Although the TST is often considered to be inexpensive, as the PPD reagent and other materials used in the testtypically cost less than $5 per test, the materials cost is only one element of the total cost involved when conducting a TB screening program or TBcontrol strategy. Substantial costs beyond the materials cost of the TST test include additional costs associated with: (i) false-negatives and false-positives, which risk non-detection and require additional confirmatory tests; (ii) individuals who fail to return within the prescribed period and, therefore,require re-testing; and (iii) implementing and maintaining training programs for healthcare workers who administer and read TST tests. Several studies have been published investigating the costs or cost-effectiveness of a TB screening program in the healthcare worker setting using the TSTand in comparison to our T-SPOT.TB test. We believe these studies are informative in demonstrating how expensive the TST actually is to implement andhow using our T-SPOT.TB test in preference to the TST can be a more cost-effective solution when implementing TB screening programs. Other than the TST, our principal competitor is the QuantiFERON®2-TB Gold Plus test, or QFN Plus, which was approved for sale in Japan in 2018, theU.S. in 2017 and has been available in Europe since 2016. Early publications suggest similar performance characteristics between QFN Plus and itspredecessor. We have been competing with QFN Plus, or prior versions of this test, since the launch of our T-SPOT.TB test in 2004. Based on our experience, webelieve that we have several performance advantages over QFN Plus, including: ●In our pivotal clinical studies conducted in support of our PMA, T-SPOT.TB test results were not impacted by immunocompromised status orimmunosuppression. The U.S. package insert for the QFN Plus test notes that the performance of the USA format of the QFN Plus test has not beenextensively evaluated with specimens from the following groups of individuals: individuals who have impaired or altered immune functions,individuals younger than age 17 years, and pregnant women. The package insert also notes that the minimum number of lymphocytes requiredfor a reliable test result has not been established and may also be variable. We believe this is an important differentiating factor in patientpopulations with weakened immune systems, such as those on biologic therapies, corticosteroid or other immunosuppressive treatments, thosewith HIV and those undergoing dialysis or organ transplantation. ●In the FDA pivotal studies in the United States, our T-SPOT.TB test was shown to have sensitivity advantages over the QFN Plus test. We have also been successful in securing differential reimbursement for T-SPOT.TB in certain geographies, including France and the U.S. In the U.S.,where we have established a unique CPT code for our test, this differential reimbursement has been maintained even following recent adjustments to theClinical Lab Fee Schedule based upon the provisions of the Protect Access to Medicare Act, or PAMA. In 2018, The Centers for Medicare & MedicaidServices, or CMS, reimbursement for our test under CPT code 86481 was approximately $100 per test; CMS reimbursement for QFN Plus under CPT code86480 was approximately $77 per test. Under PAMA, reimbursement for our T-SPOT.TB test for the years 2019-2020 will remain unchanged from 2018rates. In contrast, the reimbursement for QFN Plus will decrease to approximately $62 by 2020. Other products Our C6 Borrelia burgdorferi (Lyme) ELISA kit, or C6 Lyme ELISA kit, measures Lyme specific antibodies by leveraging a synthetic version of the C6peptide antigen, a marker specific to Borrelia burgdorferi, the causative organism of Lyme disease in the U.S. The test kit is FDA cleared and CE markedin the European Union. The test has been the subject of over 20 peer-reviewed publications. Our T-SPOT.CMV test utilizes our T-SPOT technology platform to measure the strength of a patient’s cellular immune response to antigens specific tocytomegalovirus, or CMV, and provides information that may be useful in informing management strategies of patients at risk of CMV infection anddisease, such as transplant patients. Our T-SPOT.CMV test is CE marked as a kit in the European Union. Neither test is currently a material source of revenues for the Company. 2 QuantiFERON® is a registered trademark of Qiagen N.V. 4Table of Contents Pipeline We have active development programs to enhance our T-SPOT.TB test offering. We are developing multiple product enhancements that aim to improvethe clinical utility of our test and improve test workflow and automation. We believe these enhancements will also serve to increase the barriers to entry inboth the U.S. and outside the U.S. Product development activities are inherently uncertain, and there can be no assurance that we will be able to obtain regulatory body clearance to marketour products. Delays in obtaining regulatory clearance may allow for increased competition, thereby potentially impacting the successfulcommercialization of our products. In addition, we may terminate our development efforts with respect to one or more of our products under developmentat any time, including before or during clinical trials, based upon changed market conditions. Intellectual property We seek to secure and maintain protection of the proprietary aspects of our technology platform and of our existing and planned products. We rely on acombination of patents, trademarks, trade secret and other intellectual property laws, and confidentiality, license and invention assignment agreementsand other contracts to protect our intellectual property rights. In addition, we have developed substantial knowledge in the field of immunologydiagnostics including proprietary methods that we believe provide us with a significant advantage relative to potential competitors. The intellectual property relating to our T-SPOT.TB test that we own or license includes 12 issued U.S. patents and 13 issued patents and one pendingpatent application in other jurisdictions, as well as registered trademarks, proprietary manufacturing processes and protocols, and proprietary methodsdirected towards achieving rapid throughput in assay performance. Our owned and licensed patents Many of the patent rights we own or in-license have claims directed to the use of ESAT-6 and/or CFP10 to detect Mycobacterium tuberculosis. Webelieve that these are the most important TB-specific antigens and we include peptides from both of these in our T-SPOT.TB test. We also believe thatusing an ELISPOT technique for an IGRA enhances its accuracy and suitability for use in testing individuals with compromised immune systems. Our T-SPOT.TB test employs this technique. Our technology patents contain claims to methods of measuring marker-specific effector T cell responses at a single-cell level to certain peptides of ESAT-6 to diagnose TB infection. In December 2017, as part of the settlement of our patent infringement action, we received a one-time, lump sum payment of$27.5 million from Qiagen Inc., or Qiagen. The settlement agreement included a non-exclusive, royalty-free license to certain of our patents for use inQiagen’s QFN products. See “Legal Proceedings” for more information. These patents expire in late 2019. The inventions claimed in our patents relating to removal of granulocytes from stored blood samples may also have applications in relation to otherdiseases, conditions or situations where blood samples cannot be tested soon after the blood draw. This proprietary method is a core part of the T-SPOTtechnology as it improves the stability of stored blood enabling the overnight shipment of blood samples. The patents covering these inventions expire in2027 (outside of the U.S.) and 2028 (U.S.). We also have licensed certain patents related to the detection of antibody-secreting B cells specific for HLA. We also have two patents under license andacquired a patent family application, pending in four territories, relating to additional TB antigens. The expected expiration dates of the licensed patentsrange from April 2019 to May 2032. We can give no assurance that any of our current or future research and development programs will result in thedevelopment and validation of any diagnostic test that leverages any of these patents or patent applications or otherwise. Our license and assignment agreements We currently rely upon several license agreements to obtain rights under certain patents that we believe may be necessary to make, use and sell ourproducts. We may in the future rely, at least in part, upon licensing agreements with third parties to obtain patent rights and transfers of technology,information and know-how to enable us to take advantage of research work already completed, including potentially the identification of antigens usefulfor measuring disease conditions. We believe such licensing arrangements have enabled us, and may in the future enable us, to reduce the amount of timewe need to develop and validate new diagnostic tests. We have royalty obligations under some of our current license agreements that are measured in part based upon our sales levels. Where our royaltyobligations are calculated on our net sales, the definition of net sales varies by agreement and typically resulted in a lower effective royalty rate on ourservice revenue than on sales of our kits. Currently, our aggregate royalty burden for our T-SPOT.TB test under all license and assignment agreements, as apercentage of gross product and service revenue, is in the low single digits. Under our license agreements, we may be responsible for paying, orcontributing to, patent prosecution and maintenance costs or subject to diligence obligations. We believe we are in compliance with all obligations of ourlicense agreements. 5Table of Contents Tuberculosis related patents In 2013, we entered into an assignment agreement with Isis Innovation Limited, now known as Oxford University Innovation Ltd., or Oxford Innovation,pursuant to which various patents we previously licensed from Oxford Innovation were assigned to us. We have ongoing obligations under theassignment agreement to make payments to Oxford Innovation until the patents expire and to continue to extend license rights to Oxford University, itsemployees, students, agents and appointees to use the technology for academic and research purposes. Our rights under the patents are subject to variousgrants of license rights, including (i) a license back to Oxford Innovation to maintain a pre-existing license for research use only, (ii) a pre-existing grantto a third party of non-exclusive rights under the patents covering a field of two infectious diseases, and (iii) a pre-existing grant to a third party of non-exclusive rights under the patents limited to the licensee’s internal use to monitor vaccine response. The amount we pay to Oxford Innovation for our royalty obligation is equal to a royalty rate in the low single digits. Our aggregate royalty obligationpayments to Oxford Innovation through December 31, 2018 have been $3.1 million. Our royalty obligations to Oxford Innovation will cease when thereare no valid patent claims still in force. Our license agreement with Rutgers, The State University of New Jersey, or Rutgers, grants us an exclusive license to certain patents to manufacture andcommercialize kits for in vitro diagnostic assays relating to TB other than in the ELISA format. The license was made in 2006 and has been amended in2009, 2011, 2012, 2013, 2016 and 2017. Our license is royalty-bearing, worldwide, with the right to sublicense. We have not granted any sublicensesunder this license. Rutgers has reserved the right to grant one additional license to this technology, limited to an ELISA format. To date, we do not believeRutgers has entered into any such license. We must make semi-annual royalty payments to Rutgers. Although the agreement contains minimum royalty obligations, the amount of royalties duebased on our actual sales utilizing the licensed patents has exceeded the minimum for a number of years and we expect our royalties on actual sales willcontinue to exceed the minimum for the duration of our royalty obligations. We pay a royalty rate in the low single digits. Our aggregate payments toRutgers through December 31, 2018 for signing fees, annual fees, milestones and royalties, including minimum royalties, have been $3.5 million. Ourroyalty obligations to Rutgers will cease when there are no valid patent claims still in force covering licensed products or assays. Previously, we made anumber of other payments to Rutgers for license issue fees, annual license fees and milestone payments. No such future payments are required under thelicense. Other Our C6 Lyme ELISA kit incorporates the VIsE protein and C6 peptide, the most immunodominant portion of the VIsE protein. The protein is the subjectof a patent held by Tulane University, or Tulane. We have also licensed four patents that relate to our C6 Lyme ELISA kit. The license from Tulane grantsus the exclusive right to use the C6 peptide in a diagnostic test for Lyme disease in humans. The license from Tulane has a royalty rate in the single digitsand expires in 2019 in the U.S. and in 2020 in other jurisdictions. Trademarks and other protection The trademarks we employ in our business include T-SPOT, T-Cell Xtend, T-Cell Select, Oxford Diagnostic Laboratories, or ODL, the Oxford Immunoteclogo, our laboratory logo and the word Immunetics. We have obtained registrations in the United States for T-SPOT, T-Cell Xtend, Oxford DiagnosticLaboratories, the Oxford Immunotec logo and the word Immunetics. We have also obtained or are seeking registrations for certain of these trademarks inother jurisdictions, including the United Kingdom, the European Community, Japan and China. We have also secured numerous internet domain nameregistrations. We have a policy of requiring all our employees to sign agreements that obligate them to maintain in confidence all confidential information they receiveduring the course of their employment, except in certain circumstances. Substantially all of our employees are also bound by invention assignmentobligations, which provide that rights to all inventions and other types of intellectual property, whether or not patentable, conceived by them during thecourse of employment are assigned to us. We seek to enter into similar confidentiality and invention assignment agreements with our consultants. Our trade secrets There are several areas in which we have developed trade secrets relating to manufacturing that we believe provide a competitive advantage with respectto our T-SPOT.TB test. It is essential to the performance of ELISPOT tests used to detect the release of interferon-gamma from stimulated T cells that themicrotiter plates used in the test be smoothly coated with the proper amount of interferon-gamma antibodies. For volume manufacturing, these coatedplates must also meet stringent shelf life requirements. Our plate-coating process meets these criteria and cost-effectively provides reliable results. Webelieve this approach results in significant cost savings for us without sacrificing our compliance with either good manufacturing practices or our ownhigh standards. As part of our test offerings, we use unique formulations of peptides and other reagents that we believe are important to the accuracy of our tests. Further,we have devoted substantial time and resources to the development of processes and techniques that have resulted in cost reductions in our testmanufacture and in assay performance in our service laboratory. In our U.K. ODL facility, we have streamlined the workflow process to allow for rapidthroughput, which reduces labor costs and reduces the time we take to provide test results to our customers. In addition, we have developed and validatedautomated solutions for the assay process, including proprietary protocols for maximizing efficiencies garnered from the automation equipment. Thesemethods are useful in our current test offerings, and will be applicable to future tests we may develop using our T-SPOT technology and other platforms.We believe the manufacturing process and assay performance efficiencies we have developed and employ could not easily or quickly be developed byothers. 6Table of Contents Manufacturing and laboratory facilities Our tests are generally manufactured by us from materials we obtain from a limited number of suppliers. We manufacture our T-SPOT.TB test at our U.K.corporate headquarters in Abingdon, England, where we currently lease approximately 2,800 square feet of manufacturing space. The lease covering thisspace expires in 2020 and our current rent for the manufacturing space is $95,000 annually, which is subject to change. Our manufacturing facility iscertified to ISO 13485. Our space in Abingdon also includes 6,400 square feet of storage/warehouse space. The leases covering this space expires in 2025and our current rent for the storage/warehouse space is $67,000 annually, which is subject to change. In June 2018, the Company entered into a lease for a new space in Abingdon, England, which extends through June 30, 2033, or the 143 Park Lease, thatwill allow us to combine our manufacturing, laboratory, storage and office operations into a single facility. The 143 Park Lease covers 27,000 square feetof laboratory, office, storage, manufacturing and other mixed use space. Initial rent under the 143 Park Lease is approximately $39,000 per month. Whenthe lease on the Company's existing manufacturing and laboratory facility expires in December 2020, or possibly sooner, and we fully occupy the spacesubject to the 143 Park Lease, rent will increase to $79,000 per month. Rent will be reviewed for possible increases on June 1, 2021 and every thirdanniversary after that date. Select functional groups moved into the facility in the second half of 2018. In connection with the sale of our U.S. Laboratory Services Business to Quest, we entered into a sublease with Quest for approximately 9,000 square feetof warehousing and office space in Norwood, MA. The sublease expires in November 2020. The base rent for the space subject to sublease isapproximately $17,000 per month. Key supplier relationships We use a broad range of materials in the manufacture and performance of our diagnostic tests. We purchase all raw materials used in our tests from externalsuppliers. We purchase some materials from single sources for reasons of quality assurance, sole source availability, cost effectiveness or constraintsresulting from regulatory requirements. We work closely with our suppliers to assure continuity of supply while maintaining high quality and reliability.To date, we have not experienced any significant difficulty in locating and obtaining the materials necessary to fulfill our production schedules. Becausewe believe that the only material supply relationships we have are those that pertain to our T-SPOT.TB test, we summarize these relationships below. Mabtech AB. We entered into a purchase agreement with Mabtech AB, or Mabtech, in 2010, which was amended in 2013 and again in 2017. Pursuant tothis agreement, Mabtech supplies the antibodies used to coat the membrane plates and for the detection procedure in our tests. We provide rollingforecasts of our anticipated purchases and portions of those forecasts become binding orders. We receive pricing discounts based on the volume of ourpurchases. We have agreed to purchase these antibodies exclusively from Mabtech, although our exclusivity obligations may cease in the event Mabtechraises prices by more than a certain percentage over a defined period of time and declines to match a competitive third-party quotation for the antibodies. The purchase agreement expires, unless earlier terminated, on December 31, 2023. Either party may terminate by providing written notice to the other inthe event of a material uncured breach by the other party, a liquidation, insolvency, or bankruptcy proceeding involving the other party or cessation intrading by the other party. EMD Millipore Corporation. We entered into a supply agreement with EMD Millipore Corporation, or Millipore, in 2009, which was amended in 2013and 2014, and expired on December 31, 2018. In January 2019, we entered into a new agreement with Millipore (UK) Ltd, or Merck, a subsidiary ofMillipore. Pursuant to the agreement, Merck supplies us with the membrane plates used in tests incorporating our T-SPOT technology. We provide rollingforecasts of our anticipated purchases and portions of those forecasts become binding orders. We receive pricing discounts based on the size of our orders.The agreement expires, unless earlier terminated, on December 31, 2024. Each party has the right to terminate in the event of a material uncured default bythe other party. Each party also has the right to terminate the Agreement upon at least twelve months’ prior written notice. In the event Merck exercises itsright of termination, we may continue to purchase goods under the agreement for up to twelve months following termination. MicroCoat Biotechnologie GmbH. Pursuant to our 2010 supply agreement with MicroCoat Biotechnologie GmbH, or MicroCoat, which was amended in2016, MicroCoat performs antibody coating on membrane plates using plates and antibodies we supply. Under the supply agreement, we provide rollingforecasts of our anticipated purchases and portions of those forecasts become binding orders. We receive pricing discounts based on the size of our orders.These antibody-coated plates are a component of tests using our T-SPOT technology. The current term of the agreement expires, unless earlier terminated, on December 31, 2019, subject to automatic renewals for additional one-year periodsin the absence of specified notice by either party. Each party has the right to terminate in the event of a material uncured breach by the other party, or inthe event of a bankruptcy or insolvency proceeding involving the other party. StemCell Technologies, Inc. We entered into a supply agreement with StemCell Technologies, Inc., or StemCell, in 2008, which was amended in 2011 andagain in 2017. Pursuant to this agreement, StemCell supplies us with a product that can be used with tests using our T-SPOT technology. We have the exclusive right to market this product for use in association with ELISPOT tests to detect and/or quantify T-cells for use in the in vitrodiagnosis, prognosis and/or clinical monitoring of infectious diseases, including tuberculosis, and non-infectious diseases and medical conditions, exceptour rights in China and India are non-exclusive. StemCell retains the right to sell this product for use in other applications and in our non-exclusiveterritories. We are obligated to use commercially reasonable efforts to promote sales of the product for the applications to which we have exclusive rights. 7Table of Contents We paid a signing fee in the amount of $0.1 million and milestone payments in the aggregate amount of $0.2 million. We are not obligated to makeadditional milestone payments. We are obligated to pay an annual exclusivity fee during the term of the agreement, creditable against certain futurepurchases. Our product purchases exceeded the amount of the exclusivity fee in 2017. We receive pricing discounts based on our quarterly orders. Wehave also agreed to make StemCell our supplier of choice for certain types of products, subject to performance obligations of StemCell, and we aregenerally obligated to acquire all of our requirements for such products from StemCell. The agreement expires, unless earlier terminated, on December 31, 2023, but will continue indefinitely thereafter in the absence of specified notice byeither party. Each party may terminate for material uncured breach, the insolvency or bankruptcy of the other party or the cessation of trading by ordissolution of the other party. Life Technologies Corporation. We entered into a supply and reseller agreement with Life Technologies Corporation, or Life Tech, in 2013, amended in2014, 2016 and 2017, which expired on December 31, 2018. In January 2019, we entered into an amended and restated supply and reseller agreementwith Life Tech, which will expire on December 31, 2019. Pursuant to the Agreement we purchase and resell a product that can be used in performingassays using our T-SPOT technology. We have a minimum annual purchase obligation under the agreement, as well as obligations to purchase certainamounts based on our rolling forecasts of anticipated purchases. Either party may terminate for a material uncured breach, the insolvency or bankruptcy ofthe other party, if one of our twelve-month forecasts does not reflect any anticipated purchases of product or if we purchase no product during aconsecutive twelve-month period. Key customer relationships Our customers include independent laboratories, large hospital systems and public and private institutions. Our customer relationships also include ourdistributors outside of the U.S. We believe our relationships with Quest and with two of our distributors are key customer relationships. Quest Diagnostics, Incorporated. We have a supply agreement with Quest Diagnostics, Incorporated, or Quest, which was made as of the closing of thesale of our U.S. Laboratory service business to Quest. Pursuant to the supply agreement, we sell T-SPOT.TB kits and certain accessories to Quest. Theagreement expires on November 6, 2025. Each party may terminate the supply agreement for a material uncured breach or in any event of bankruptcy oran equivalent winding up of the other party’s business. Shanghai Fosun Long March Medical Science Co. Ltd. We have a distribution agreement with Shanghai Fosun Long March Medical Science Co. Ltd., orFosun, pursuant to which Fosun distributes our TB-related products in China. Under the distribution agreement, Fosun serves as our exclusive distributorin a territory consisting of the People’s Republic of China, including Macau Special Administrative Regions, and also serves as our non-exclusivedistributor in Hong Kong. Fosun commits to using its best efforts to promote, sell and distribute our products in the territory in compliance with ourpolicies and procedures and applicable law. The agreement imposes certain annual minimum purchase obligations at agreed upon pricing and covers ourproducts, as well as other accessories which may be used in conjunction with our products. Fosun is obligated to refrain from dealing in any products inthe territory which would be competitive with ours through a period extending 12 months after the termination of the agreement. The agreement expires on January 1, 2021. Either party may terminate the agreement for a material uncured breach or in the event of bankruptcy or anequivalent winding up of the other party’s business. We may terminate the agreement if Fosun does not meet the minimum purchase requirements, for latepayment or if Fosun undergoes a change in control. We amended the agreement twice during 2018 to adjust the rebate available upon Fosun’sachievement of minimum purchase quantities. Riken Genesis Co., Ltd. We sell our T-SPOT.TB test to a Japanese importer, Riken Genesis Co., Ltd., or Riken, which also serves as our marketingauthorization holder in Japan, a position required by Japanese regulatory authorities. We entered into a marketing authorization holder agreement withRiken in 2011 and it was amended in 2013, 2016 and 2017. Pursuant to this agreement, Riken provides services for importation into Japan. We initiallypaid an initiation fee to Riken in the amount of ¥200,000, or approximately $1,600. We currently pay Riken a flat monthly fee in the amount of¥150,000, or approximately $1,300, and also pay a single-digit percentage commission based on the prices at which end users purchase our products. Theinitial agreement with Riken had a one-year term and automatically renews for additional one-year periods in the absence of specified notice by eitherparty. Either party may terminate for a material uncured breach or in the event of bankruptcy, insolvency or similar proceedings of the other party. Government regulation Federal Food, Drug, and Cosmetic Act In the United States, in vitro diagnostics, or IVDs, are regulated by the FDA as either medical devices or biological products under the Federal Food, Drug,and Cosmetic Act, or FDCA, depending on their intended use. IVDs that are used as diagnostics are regulated as medical devices. 8Table of Contents Marketing pathways There are two regulatory pathways to receive authorization to market IVDs intended for diagnostic purposes: a premarket application, or PMA, and a510(k) premarket notification. The FDCA establishes a risk-based standard for determination of the pathway for which a particular IVD device is eligible. The information that must be submitted to the FDA to obtain clearance or approval to market a new medical device varies depending on how the medicaldevice is classified by the FDA. Medical devices are classified into one of three classes on the basis of the controls necessary to reasonably ensure theirsafety and effectiveness. Class I devices are subject to general controls, including labeling and adherence to the FDA’s quality system regulation, whichestablishes device-specific good manufacturing practices. Class II devices are subject to general controls and special controls, including performancestandards and post-market surveillance. Class III devices are subject to these requirements as well as to premarket approval. Most Class I devices areexempt from premarket submissions to the FDA; most Class II devices require the submission of a 510(k) premarket notification to the FDA; and Class IIIdevices require submission of a PMA application. Our T-SPOT.TB test is a Class III device and our C6 Lyme ELISA kit is a Class II device. We have otherClass II devices that have received 510(k) clearance from FDA that we acquired through our acquisition of Immunetics. Premarket approval. The PMA process, by which we received marketing authorization for our T-SPOT.TB test in 2008, is complex, costly and timeconsuming. A PMA application must be supported by detailed and comprehensive scientific evidence, including clinical data, to demonstrate the safetyand efficacy of the medical device for its intended purpose. If the device is determined to present a “significant risk,” the sponsor may not begin a clinicaltrial until it submits an investigational device exemption, or IDE, to the FDA and obtains approval from the FDA to begin the trial. After the PMAapplication is submitted, the FDA has 45 days to make a threshold determination that the application is sufficiently complete to permit a substantivereview. If the application is complete, the FDA will accept it for filing. The FDA is subject to a non-binding performance goal review time for a PMAapplication of 180 days from the date of filing, although in practice this review time is often longer. Questions from the FDA, requests for additional dataand referrals to advisory committees may delay the process considerably. Indeed, the total process may take several years and there is no guarantee thatthe PMA application will ever be approved. Even if approved, the FDA may limit the indications for which the device may be marketed. The FDA mayalso request additional clinical data as a condition of approval or after the PMA is issued. Any changes to the medical device may require a supplementalPMA application to be submitted and approved. Since we received initial PMA application approval of our T-SPOT.TB test in 2008, the FDA has grantedapproval for ten supplemental PMA applications for our T-SPOT.TB test, including supplements relating to the use of our T-Cell Xtend reagent with our T-SPOT.TB test. 510(k) Clearance. Our C6 Lyme ELISA kit has obtained 510(k) clearance from FDA. A traditional 510(k) submission requires demonstration ofsubstantial equivalence to a previous legally marketed device that was not subject to PMA. If a substantial equivalence cannot be demonstrated and thetest is of low to moderate risk, the FDA may allow a de novo 510(k) submission. Submission of either a traditional or de novo 510(k) notification is subjectto a 90-day FDA review period. Questions from the FDA, requests for additional data and referrals to advisory committees may delay the processconsiderably and the FDA may ultimately limit the indications for which the device may be marketed. Marketing of an IVD medical device may begin assoon as FDA clearance is granted. Post-marketing regulations and controls Under the medical device regulations, the FDA regulates quality control and manufacturing procedures by requiring us to demonstrate and maintaincompliance with the quality system regulation, which sets forth the FDA’s current good manufacturing practices requirements for medical devices. TheFDA monitors compliance with the quality system regulation and current good manufacturing practices requirements by conducting periodic inspectionsof manufacturing facilities. FDA inspections in the United States are typically unannounced. FDA inspections outside the United States are coordinatedwith the companies being inspected. Violations of applicable regulations noted by the FDA during inspections of our manufacturing facilities couldadversely affect the continued marketing of our tests. The FDA also enforces post-marketing controls that include the requirement to submit product reports to the agency when a manufacturer becomes awareof information suggesting that any of its marketed products may have caused or contributed to a death, serious injury or serious illness or any of itsproducts has malfunctioned and that a recurrence of a malfunction would likely cause or contribute to a death or serious injury or illness. The FDA relieson product reports to identify product problems and utilizes these reports to determine, among other things, whether it should exercise its enforcementpowers. The FDA also enforces the requirement that manufacturers submit reports of recalls and field actions to the FDA if the actions are initiated toreduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health. The FDA may also require post-marketsurveillance studies for specified devices. FDA regulations also govern, among other things, the preclinical and clinical testing, manufacture, distribution, labeling and promotion of medicaldevices and biological products. In addition to compliance with good manufacturing practices and product reporting requirements, we are required tocomply with the FDCA’s general controls, including establishment registration, device listing and labeling requirements. If we fail to comply with anyrequirements under the FDCA, we could be subject to, among other things, fines, injunctions, civil penalties, recalls or product corrections, total or partialsuspension of production, denial of premarket notification clearance or approval of products, rescission or withdrawal of clearances and approvals, andcriminal prosecution. We cannot assure you that any final FDA policy, once issued, or future laws and regulations concerning the manufacture ormarketing of medical devices will not increase the cost and time to market of new or existing tests. If we fail to comply with these FDA regulations orguidelines, we may be subject to warnings from, or enforcement action by, the FDA. 9Table of Contents International Medical Device Regulations International marketing of medical devices is subject to foreign government regulations, which vary substantially from country to country. The EuropeanCommission is the legislative body responsible for directives with which manufacturers selling medical products in the European Union and the EuropeanEconomic Area, or EEA, must comply. The European Union includes most of the major countries in Europe, while other countries, such as Switzerland, arepart of the EEA and have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices. The EuropeanUnion has adopted directives that address regulation of the design, manufacture, labeling, clinical studies and post-market vigilance for medical devices,including IVDs. Devices that comply with the requirements of a relevant directive, including the IVD Directive (Directive 98/79 EC), will be entitled tobear the CE conformity marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can bemarketed throughout the European Union and EEA. Outside of the European Union, regulatory pathways for the marketing of medical devices vary greatly from country to country. In many countries, localregulatory agencies conduct an independent review of IVD medical devices prior to granting marketing approval. For example, in China, approval by theCFDA, must be obtained prior to marketing an IVD medical device. In Japan, approval by the MHLW following review by the Pharmaceuticals andMedical Devices Agency, or the PMDA is required prior to marketing an IVD. The process in such countries may be lengthy and require the expenditureof significant resources, including the conduct of clinical trials. In other countries, the regulatory pathway may be shorter and/or less costly. The timelinefor the introduction of new IVD medical devices is heavily impacted by these various regulations on a country-by-country basis, which may become morelengthy and costly over time. Our T-SPOT.TB test has been approved for sale in over 50 countries, including in Europe, China, and Japan. Our T-SPOT.TB test obtained a CE mark in2004, CFDA approval in China in 2010 and re-registration in 2014, and MHLW approval in Japan in 2012. Our T-SPOT.CMV test obtained a CE mark in2015 and our C6 Lyme ELISA kit obtained a CE mark in 2011. Laboratory certification, accreditation and licensing Our laboratory located in the United Kingdom operates under accreditation by the United Kingdom Accreditation Service, or UKAS, for the InternationalStandard: ISO 17025:2017 (General requirements for the competence of testing and calibration laboratories). Compliance with this standard is required tomaintain accreditation and the continued use of the UKAS logo on our laboratory documentation. National Health Service (NHS)-based customers requirethat the testing services they procure operate to an accredited quality management system, which is evidenced by the UKAS accreditation. Therefore, afailure to maintain this accreditation could cause us to lose a substantial majority of our U.K. service business. HIPAA and other privacy laws U.S. Health Insurance Portability and Accountability Act, or HIPAA, established for the first time in the United States comprehensive protection for theprivacy and security of health information. The HIPAA standards apply to three types of organizations, or Covered Entities: health plans, healthcareclearing houses, and healthcare providers that conduct certain healthcare transactions electronically. Covered Entities and their Business Associates, asdefined in HIPAA, must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable healthinformation. Since the divestiture of our U.S. Laboratory Services Business, we are no longer a Covered Entity. We may conduct other activities that mayimplicate HIPAA, such as conducting clinical studies or entering into specific kinds of relationships with a Covered Entity or a Business Associate of aCovered Entity. If we or our operations are found to be in violation of HIPAA, HITECH or their implementing regulations, we may be subject to penalties, including civiland criminal penalties, fines, and exclusion from participation in U.S. federal or state health care programs, and the curtailment or restructuring of ouroperations. HITECH increased the civil and criminal penalties that may be imposed against Covered Entities, their Business Associates and possibly otherpersons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA lawsand seek attorney’s fees and costs associated with pursuing federal civil actions. Our activities must also comply with international privacy laws that impose restrictions on the access, use, and disclosure of health information. Forexample, the European General Data Protection Regulation covers personal information of citizens of the European Union and imposes strict penalties fornoncompliance. All of these laws may impact our business. Our failure to comply with these privacy laws or significant changes in the laws couldsignificantly impact our business and our future plans. U.S. federal and state “anti-kickback” restrictions The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly orindirectly, to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may bemade under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” is not defined in the federal Anti-Kickback Statute and has been broadly interpreted to include anything of value, including for example, gifts, discounts, the furnishing of supplies orequipment, credit arrangements, payments of cash, waivers of payment, ownership interests and providing anything at less than its fair market value. 10Table of Contents Many states have also adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items orservices reimbursed by any source, not only the Medicare and Medicaid programs, and do not contain identical safe harbors. If we or our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may besubject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal or state health care programs, andthe curtailment or restructuring of our operations. We may also be subject to similar foreign laws and regulations. U.S. health care reform In March 2010, the PPACA was enacted, which included measures that significantly changed the way healthcare is financed by both governmental andprivate insurers. Changes were made to the PPACA as part of the Tax Cuts and Jobs Act of 2017 to remove certain parts of the original legislation and thecurrent Congress continues to make efforts to repeal and/or replace the PPACA. The Physician Payment Sunshine Act, enacted as part of PPACA, has notbeen repealed and requires medical device manufacturers to track certain financial arrangements with physicians and teaching hospitals, including any“transfer of value” made or distributed to such entities, as well as any investment interests held by physicians and their immediate family members.Manufacturers are required to report this information to CMS. Various states have also implemented regulations prohibiting certain financial interactionswith healthcare professionals and/or mandating public disclosure of such financial interactions. We may incur significant costs to comply with such lawsand regulations now or in the future. Other laws We are also subject to numerous U.S. federal, state and local laws as well as international laws relating to such matters as safe working conditions,manufacturing practices, environmental protection, fire hazard control, and transportation and disposal of blood and hazardous or potentially hazardoussubstances. We may incur significant costs to comply with such laws and regulations now or in the future. Employees As of December 31, 2018, we had 210 employees. None of our employees is covered under a collective bargaining agreement. We have not experiencedany work stoppages and we believe our employee relations are good. Environmental matters Our operations require the use of hazardous materials, which, among other matters, subjects us to a variety of national, state and local environmental,health and safety laws, regulations and permitting requirements, including those relating to the handling, storage, transportation and disposal ofbiological and hazardous materials and wastes. The primary hazardous materials we handle or use include human blood samples and solvents. Some of theregulations under the current regulatory structure provide for strict liability, holding a party liable for contamination at currently and formerly owned,leased and operated sites and at third-party sites without regard to fault or negligence. We could be held liable for damages and fines as a result of our, orothers’, operations or activities should contamination of the environment or individual exposure to hazardous substances occur. We could also be subjectto significant fines for failure to comply with applicable environmental, health and safety requirements. We cannot predict how changes in laws ordevelopment of new regulations will affect our business operations or the cost of compliance. Available information Access to our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to these reports filed with orfurnished to the SEC may be obtained through the investor section of our website at www.oxfordimmunotec.com as soon as reasonably practical after weelectronically file or furnish these reports. We do not charge for access to and viewing of these reports. Information in the investor section and on ourwebsite is not part of this Annual Report on Form 10-K or any of our other securities filings unless specifically incorporated herein by reference. Inaddition, the public may read and copy any materials that we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C.20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. Also, our filings withthe SEC may be accessed through the SEC’s website at www.sec.gov. All statements made in any of our securities filings, including all forward-lookingstatements or information, are made as of the date of the document in which the statement is included, and we do not assume or undertake any obligationto update any of those statements or documents unless we are required to do so by law. 11Table of Contents Corporate information Oxford Immunotec Global PLC was incorporated in England and Wales in 2013. Our principal executive offices are located at 94C Innovation Drive,Milton Park, Abingdon, OX14 4RZ, United Kingdom, and our telephone number is +44 (0) 1235 442 780. Our internet website iswww.oxfordimmunotec.com. The information on, or that can be accessed through, our website is not part of this Annual Report on Form 10-K. Item 1A. Risk Factors Risks related to our business. We have a history of losses and we cannot be certain that we will achieve or sustain profitability. We have a history of losses and may continue to incur losses from continuing operations. For the fiscal years ended December 31, 2018, 2017 and 2016,we had income (losses) from continuing operations of $12.5 million, $(33.2) million and $(21.6) million, respectively, and we had an accumulated deficitat December 31, 2018 of $80.8 million. Substantially all of our operating losses in these periods resulted from costs incurred in connection with sales andmarketing of our T-SPOT.TB test, general and administrative costs associated with our operations and our research and development programs. Weanticipate that our operating losses may decline following the sale of our U.S. Laboratory Services Business to Quest, as we intend to reduce overheadcosts and refocus our business on the sale of kits. Because of the numerous risks and uncertainties associated with developing and commercializingdiagnostic products, we cannot be certain that we will achieve or sustain profitability. Our ability to generate profits on sales of our T-SPOT.TB test issubject to market acceptance in market segments we currently serve, as well as in new market segments and new geographies, and our ability to obtainregulatory body clearance to market any of our products. In addition, we may be compelled to sell our T-SPOT.TB test at lower prices if, for example, ourcustomers or prospective customers are unwilling to pay for our tests at current pricing levels or as a result of increased competition generally. Any priceerosion would impede our ability to generate revenue. If we are unable to generate sufficient revenue, we will not become profitable and may be unable tocontinue operations without continued funding. We may require substantial additional capital resources to fund our operations. We may not be able to obtain additional capital resources onfavorable terms and if we cannot find additional capital resources, we may have difficulty operating our business. Raising additional capital may alsocause dilution to our existing shareholders. As of December 31, 2018, we had cash and cash equivalents of $192.8 million and working capital (total current assets less total current liabilities) of$198.8 million. While we anticipate that our current cash, cash equivalents and cash generated from operations will be sufficient to meet our projectedoperating plans for at least the next 12 months, we may require additional funds, either through additional equity or debt financings, strategiccollaboration agreements, sale of assets or from other sources. Additional financing opportunities may not be available to us, or if available, may not beon favorable terms. Further, to the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest ofour shareholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our shareholders. Our futurecapital requirements will depend on many factors, including revenue generated from the sale of our T-SPOT.TB test, margins, operating expenses and ourability to control costs associated with our operations, and the costs of filing, prosecuting, maintaining, defending and enforcing any patent claims andother intellectual property rights. The availability of additional capital will also depend on many factors, including the market price of our ordinary sharesand the availability and cost of additional equity capital from existing and potential new investors, our ability to retain the listing of our ordinary shareson The NASDAQ Global Market and general economic and industry conditions affecting the availability and cost of capital. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurringadditional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensingarrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates beyond the rights we have alreadyrelinquished, or grant licenses on terms that are not favorable to us. We are currently heavily dependent on the successful further commercialization of our T-SPOT.TB test and, if we encounter delays or difficulties in thefurther commercialization of this product, our business could be harmed. Our future success is heavily dependent upon the successful further commercialization of our T-SPOT.TB test. Following the completion of the sale of ourU.S. laboratory services business to Quest in November 2018, we expect substantially all of our revenue to be derived from sales of products such asdiagnostic test kits and related accessories going forward. There is no assurance that we will continue to generate revenues from our T-SPOT.TB test, orany products under development, in the future. Our business could be materially harmed if we encounter difficulties in the further commercialization ofthis product, including, among others: failure to achieve sufficient market acceptance by hospitals and public health departments as well as physicians,third-party payors and others in the medical community; the inability to compete with other diagnostic methods, including the TST; the inability tomaintain and expand our sales, marketing and distribution networks; the inability to manage anticipated growth; the inability to obtain and/or maintainnecessary regulatory approvals; and the inability to effectively protect our intellectual property. 12Table of Contents If we do not achieve, sustain or successfully manage our anticipated growth, our business and financial results may be adversely affected. Further development and commercialization of our T-SPOT.TB test and other diagnostic product candidates will require us to expand our sales, marketingand distribution networks. Such growth may place significant strains on our management and our internal systems and processes, as well as potentiallythose of our suppliers, and if we cannot effectively manage expanding operations and costs, we may not be able to continue to grow or we may grow at aslower pace and our business and financial results could be adversely affected. Our financial results will depend on the market acceptance and increased demand of our products by hospitals and public health departments, as wellas physicians and others in the medical community.Our future success depends on our products gaining sufficient market acceptance by hospitals and public health departments. If our products do notachieve an adequate level of acceptance by such customer groups, we may not generate enough revenue to become profitable. For example, the degree ofmarket acceptance of our T-SPOT.TB product will depend on a number of factors, including: ●clinical guidelines relative to the screening for, and diagnosis and monitoring of, TB infection; ●the efficacy and potential advantages of our T-SPOT.TB test over alternative tests; ●the willingness of our target customers to accept and adopt our T-SPOT.TB test; ●the ability to offer attractive pricing for our T-SPOT.TB test; ●the strength of marketing and distribution support and the timing of market introduction of competitive products; and ●outcomes from clinical studies and other publicity concerning our T-SPOT.TB test or competing products. Our efforts to educate physicians and other members of the medical community on the benefits of our T-SPOT.TB test may require significant resourcesand may never be successful. Such efforts to educate the marketplace may require more resources than are required by conventional technologiesmarketed by our competitors. In particular, continuing to gain market acceptance for our T-SPOT.TB test in nascent markets could be challenging. Incertain markets, including, for example, Japan and China, our potential for future growth is difficult to forecast. If we were to incorrectly forecast ourability to penetrate these markets, expenditures that we make may not result in the benefits that we expect, which could harm our results of operations.Moreover, in the event that our T-SPOT.TB test is the subject of guidelines, clinical studies or scientific publications that are unhelpful or damaging, orotherwise call into question the benefits of our T-SPOT.TB test, we may have difficulty in convincing prospective customers to adopt our test. Moreover,the perception by the investment community or shareholders that recommendations, guidelines or studies will result in decreased use of our productscould adversely affect the prevailing market price for our ordinary shares. Similar challenges apply to all of the products in our pipeline. The success of our T-SPOT.TB test depends on the continued demand for diagnostic products for tuberculosis. Even if we achieve market acceptance, our success will depend on continued demand for diagnostic products for tuberculosis. Tuberculosis screeningpolicies could change such that tests are conducted less frequently or in fewer instances. For example, healthcare institutions facing increased cost controlrequirements could determine to reduce employee testing. In addition, various institutions or governing bodies may decide that the incidence of TB hasdropped sufficiently within their screening population so as to permit reduced testing (e.g., U.S. military guidelines were updated in recent years such thattesting may now be required in fewer instances than under previous guidelines). Changes to immigration policies and policies relating to resettlement ofrefugees, as well as other policy changes may substantially reduce testing in the markets we serve and could have a material and adverse effect on ourbusiness. New market opportunities may not develop as quickly as we expect, limiting our ability to market and sell our T-SPOT.TB test successfully. We intend to take steps to continue to increase the presence of our T-SPOT.TB test in new markets both in the United States and internationally. Weintend to expand our sales force globally and establish additional distributor relationships outside of our direct markets to better access internationalmarkets. We believe these opportunities will take substantial time to develop or mature, however, and we cannot be certain that these marketopportunities will develop as we expect. The future growth and success of our T-SPOT.TB test in these markets depends on many factors beyond ourcontrol, including recognition and acceptance by the scientific community in that market and the prevalence and costs of competing methods oftuberculosis screening. If the markets for our T-SPOT.TB test do not develop as we expect, our business may be adversely affected. In connection with the Transaction, we entered into a supply agreement and strategic collaboration agreement with Quest. If we are unable to meet ourobligations under these agreements, our business could be adversely affected. In connection with the Transaction, we entered into a supply agreement pursuant to which we agreed to sell, and Quest agreed to purchase, T-SPOT.TB testkits and related accessories. Additionally, we entered into a strategic collaboration agreement with Quest to drive continued growth of T.SPOT.TB testingin the U.S. If we fail to meet our obligations under the supply agreement or if our collaboration with Quest does not result in the continued growth ofT.SPOT.TB testing in the U.S., our business may be adversely affected. 13Table of Contents Our T-SPOT.TB test competes with other diagnostic testing methods that may be more widely accepted than our test, and may compete with newdiagnostic tests that may be developed by others in the future, which could impair our ability to maintain and grow our business and remaincompetitive. The clinical diagnostics market is highly competitive, and we must be able to compete effectively against existing and future competitors in order to besuccessful. In selling our T-SPOT.TB test, we compete primarily with existing diagnostic technologies, particularly the TST, which is widely used as a testfor TB infection. In addition, we compete with QFN which, like our T-SPOT.TB test, employs an IGRA method for detecting tuberculosis infection. If weare unable to differentiate our diagnostic tests from those of our competitors, our business may be materially and adversely affected. In addition,improvements in these technologies or the development of new technologies for diagnosing tuberculosis and the introduction of products that competewith our T-SPOT.TB test could adversely impact our ability to sell our T-SPOT.TB test or the sales price of the test. This could impact our ability to marketour test and/or secure a distribution partner, both of which could have a substantial impact on the value of our T-SPOT.TB test. We also face competition in the development, manufacture, marketing and commercialization of diagnostic products from a variety of other sources, suchas academic institutions, government agencies, research institutions and other life sciences companies. These competitors are working to develop andmarket other diagnostic tests, systems, products and other methods of detecting, preventing or reducing tuberculosis. Among the many experimental diagnostics being developed around the world, there may be diagnostics unknown to us that may compete with our T-SPOT.TB test. Many of our potential competitors have much greater capital resources, manufacturing, research and development resources and productionfacilities than we do. Competitors with greater resources may be able to offer tests and/or services at prices at which we are unable to compete and morequickly develop improvements than we are. Many of them may also have more experience than we have in preclinical testing and clinical trials of newdiagnostic tests. The markets for our T-SPOT.TB test are subject to changing technology, new product introductions and product enhancements, and evolving industrystandards. The introduction or enhancement of products embodying new technology or the emergence of new industry standards could render existingproducts obsolete or result in short product life cycles or our inability to sell our T-SPOT.TB test without offering a significant discount. Our future success depends on our ability to successfully develop, obtain clearance or approval for and commercialize new products. Our future success partially depends on our ability to successfully develop and market new products. Our ability to develop any of these products isdependent on a number of factors, including funding availability to complete development efforts; our ability to develop products that adequately detector measure the targeted function, condition or disease; our ability to secure required FDA or other regulatory clearance or approval and our ability toobtain licenses to necessary third-party intellectual property. We may encounter problems in the development phase for our products, which can result insubstantial setbacks and delays or abandonment of further work on the potential product. There can be no assurance that we will not encounter suchsetbacks with the products in our pipeline, or that funding from outside sources and our revenue will be sufficient to bring any future product to the pointof commercialization. In addition, our future success partially depends on the successful completion of clinical trials demonstrating the utility of our product candidates. Wecurrently have a number of pipeline products in development, some of which are or may become the subject of pivotal trials to demonstrate sufficientutility to support successful market adoption and/or to obtain regulatory approval for sale. Not all of our clinical trials may actually result in thesuccessful commercialization of a product. We will not be able to commercialize our pipeline products if clinical trials do not produce successful resultsor if clinical trials do not demonstrate utility. In addition, the process for the completion of clinical trials and the regulatory approval submission processare lengthy and may be subject to a number of delays for various reasons, which could delay the commercialization of any product. If our developmentprojects are not successful or are significantly delayed, we may not recover our substantial investments in the pipeline products, and our failure to bringthese pipeline products to market on a timely basis, or at all, would adversely affect our business, results of operations and financial condition. Even if we are successful in developing new products and securing regulatory approval to market them, we may not be able to achieve marketplaceacceptance for our new products or generate significant revenue from their sale. As with our current T-SPOT.TB test, the success of any future products willdepend upon the degree of market acceptance by physicians, hospitals, third-party payors and others in the medical community. Achieving marketacceptance will require us to expend substantial time and resources to educate physicians and other members of the medical community on the benefits ofany new product we develop and we may never be successful in gaining market acceptance of our new products. There can be no assurance that theproducts we seek to develop will work effectively in the marketplace, or that we will be able to produce them on an economical basis. If we are unable to maintain and expand our network of direct sales representatives and independent distributors, we may not be able to generateanticipated sales. We sell our T-SPOT.TB test through our own sales force in the United States, certain European countries and Japan and we sell through distributors inother parts of the world such as in China. Our operating results are directly dependent upon the sales and marketing efforts of not only our employees, butalso our independent distributors. We expect our direct sales representatives and independent distributors to develop long-lasting relationships with theproviders they serve. If our direct sales representatives or independent distributors fail to adequately promote, market and sell our product, our sales couldsignificantly decrease. 14Table of Contents We face significant challenges and risks in managing our geographically dispersed sales and distribution network and retaining the individuals who makeup that network. If a substantial number of our direct sales representatives were to leave us within a short period of time, or if a substantial number of ourindependent distributors were to cease to do business with us within a short period of time, our sales could be adversely affected. If any significantindependent distributor were to cease to distribute our product, our sales could be adversely affected. In such a situation, we may need to seek alternativeindependent distributors or increase our reliance on our direct sales representatives, which may not prevent our sales from being adversely affected. If adirect sales representative or independent distributor were to depart and be retained by one of our competitors, we may be unable to prevent them fromhelping competitors solicit business from our existing customers, which could further adversely affect our sales. Because of the intense competition fortheir services, we may be unable to recruit additional qualified independent distributors or to hire additional qualified direct sales representatives to workwith us. We may also not be able to enter into agreements with them on favorable or commercially reasonable terms, if at all. Failure to hire or retainqualified direct sales representatives or independent distributors would prevent us from expanding our business and generating sales. See “Certain of ourcustomers account for a significant portion of our revenue.” As we launch new products and increase our sales, marketing and distribution efforts with respect to our T-SPOT.TB test, we will need to expand the reachof our sales, marketing and distribution networks. Our future success will depend largely on our ability to continue to hire, train, retain and motivateskilled direct sales representatives and independent distributors with significant technical knowledge in various areas. New hires require training and taketime to achieve full productivity. If we fail to train new hires adequately, or if we experience high turnover in our sales force in the future, we cannot becertain that new hires will become as productive as may be necessary to maintain or increase our sales. If we are unable to expand our sales and marketing capabilities domestically and internationally, we may not be able to effectively commercialize ourproducts, which would adversely affect our business, results of operations and financial condition. Health insurers and other payors may decide not to cover, or may discontinue reimbursing, our T-SPOT.TB test or any other diagnostic tests we offeror may offer, or may provide inadequate reimbursement, which could jeopardize our ability to expand our business. Although for many of our current customers, the cost of screening their employees for tuberculosis is not reimbursable, our business is somewhatimpacted, and in the future may be more greatly impacted, by the level of reimbursement from payors or governmental limitations on price. In the UnitedStates, the regulatory process allows diagnostic tests to be marketed regardless of any coverage determinations made by payors. For new diagnostic tests,each payor makes its own decision about which tests it will cover, how much it will pay and whether it will continue reimbursing the test. Clinicians mayorder diagnostic tests that are not reimbursed if the patient is willing to pay for the test without reimbursement, but coverage determinations andreimbursement levels and conditions are important to the commercial success of a diagnostic product. In addition, eligibility for coverage does not implythat any product will be covered and reimbursed in all cases or reimbursed at a rate that allows our potential customers to make a profit or even cover theircosts. CMS establishes reimbursement payment levels and coverage rules for Medicare. CMS currently covers our T-SPOT.TB test. If CMS were to placesignificant restrictions on the use of our tests, reduce payment amounts or eliminate coverage altogether, our ability to generate revenue from ourdiagnostic tests could be limited. For example, payment for diagnostic tests furnished to Medicare beneficiaries is made based on a fee schedule set byCMS. In July 2013, CMS released certain proposals that re-examined payment amounts for tests reimbursed under the Medicare clinical laboratory feeschedule due to changes in technology. CMS also proposed to bundle the Medicare payments for certain laboratory tests ordered while a patient receivedservices in a hospital outpatient setting, replacing the current methodology to make separate payments for the test. These changes went into effect onJanuary 1, 2014. In addition, payment methodologies may be subject to changes in healthcare legislation. In February 2012, President Obama signed theMiddle Class Tax Relief and Job Creation Act of 2012, which mandated an additional change in reimbursement for clinical laboratory services payments.This legislation required CMS to reduce the Medicare clinical laboratory fee schedule by 2% in 2013, which in turn serves as the base for 2014 andsubsequent years. Levels of reimbursement may continue to decrease in the future, and future legislation, regulation or reimbursement policies of third-party payors may harm the demand and reimbursement available for our T-SPOT.TB test, which in turn, could harm our product pricing and sales. If ourcustomers are not adequately reimbursed for our T-SPOT.TB test, they may reduce or discontinue purchases of our product, which would cause ourrevenues to decline. The Protecting Access to Medicare Act of 2014, or PAMA, includes extensive revisions to the Medicare payment, coding, and coverage requirementsfor clinical diagnostic laboratory tests as well as creates a new subcategory of Clinical Diagnostic Lab Test (CDLT) called Advanced DiagnosticLaboratory Tests (ADLTs) with separate reporting and payment requirements. Beginning in 2018, the Medicare payment rate for each CDLT is equal tothe weighted median amount for the test from the most recent data collection period. The payment rate will apply to laboratory tests furnished by ahospital laboratory if the test is separately paid under the hospital outpatient prospective payment system. The PAMA rate changes to our tests that wereimpacted did not materially affect our payments beginning in 2018; however, we cannot predict how this may change future payment in coming years. Perthe final payment rates and supporting documentation for the new private payor rate-based CLFS payment system published by CMS in late 2017, CMSreimbursement per test for CPT code 86481 is expected to be $100 in years 2018, 2019, and 2020. 15Table of Contents In addition, state Medicaid plans and private commercial payors establish rates and coverage rules independently. As a result, the coverage determinationprocess is often a time-consuming and costly process that requires us to provide scientific and clinical support for the use of our tests to each payorseparately, with no assurance that coverage or adequate reimbursement will be obtained. Even if one or more third-party payors decides to reimburse forour tests, that payor may reduce utilization or stop or lower payment at any time, which could reduce our revenue. We cannot predict whether or whenthird-party payors will cover our tests or offer adequate reimbursement to make them commercially attractive. Clinicians may decide not to order our testsif inadequate third-party payments result in additional costs to the patient. We are also subject to foreign reimbursement and payment schemes in the international markets we serve, including Japan, Switzerland, Germany, Franceand South Korea. Decisions by health insurers or other third-party payors in these markets not to cover, or to discontinue reimbursement, or governmentallimitations on price could materially and adversely affect our business. Billing complexities associated with obtaining payment or reimbursement for our tests may negatively affect our revenue, cash flow and profitability. Although third-party payors only accounted for a small percentage of our total revenue for the year ended December 31, 2018, we currently rely in part,and may in the future more heavily rely, on obtaining third-party payment or reimbursement for our test. Our customers receive payment from individualpatients and from a variety of payors, such as commercial insurance carriers, including managed care organizations and governmental programs, primarilyMedicare and Medicaid in the United States. Each payor typically has different billing requirements, and the billing requirements of many payors havebecome increasingly stringent. Among the factors complicating billing of, and obtaining payment through, third-party payors are: ●disputes among payors as to which party is responsible for payment; ●disparity in coverage among various payors; ●disparity in information and billing requirements among payors; ●incorrect or missing billing information, which is required to be provided by the ordering physician; and ●payments may be sent directly to patients rather than to us. These billing complexities, and the related uncertainty in obtaining payment for our tests, could negatively affect our customers' ability to get paid for ourtest and, by extension, our revenue, cash flow and profitability. We depend upon a limited number of suppliers, and certain components of our products may only be available from a sole source or limited number ofsuppliers. Our tests are generally assembled by us from supplies we obtain from a limited number of suppliers. Critical components required to assemble our testsmay only be available from a sole or limited number of component suppliers. For example, we source key components of our T-SPOT.TB test from EMDMillipore Corporation, Stemcell Technologies Inc., Mabtech AB, MicroCoat Biotechnologie GmbH and Life Technologies Corporation, any of whomwould be difficult to replace. Even if the key components that we source are available from other parties, the time and effort involved in obtaining anynecessary regulatory approvals for substitutes could impede our ability to replace such components timely or at all. The loss of a sole or key supplierwould impair our ability to deliver products to our customers in a timely manner and would adversely affect our sales and operating results and negativelyimpact our reputation. Our business would also be harmed if any of our suppliers could not meet our quality and performance specifications and quantityand delivery requirements. Certain of our customers account for a significant portion of our revenue. We sell our T-SPOT.TB test through a direct sales force in the United States, certain European countries and Japan. In Japan, while we maintain end-userrelationships through our direct sales force, we sell through a single importer of record, Riken. In other parts of the world, we sell through distributors. Forexample, in China, we sell through a single distributor, Fosun. For the year ended December 31, 2018, sales to Fosun and through Riken togetheraccounted for 46% of our total revenue, with Fosun accounting for 27% and Riken accounting for 19%. As a result of the Transaction, Quest has become asignificant customer in the U.S. and will comprise a significant portion of our U.S. revenues. In the event that any of these customers or any othersignificant customer substantially reduces its purchases of our products, particularly if this occurs without adequate advance notice to enable us to securealternate importation or distribution arrangements, our results of operations could be materially and adversely affected. We or our suppliers may experience development or manufacturing problems or delays that could limit the growth of our revenue or increase ourlosses. We may encounter unforeseen situations in the manufacture and assembly of our T-SPOT.TB test that would result in delays or shortfalls in ourproduction. Our suppliers may also face similar delays or shortfalls. In addition, our or our suppliers’ production processes and assembly methods mayhave to change to accommodate any significant future expansion of our manufacturing capacity, which may increase our or our suppliers’ manufacturingcosts, delay production of our product, reduce our product margin and adversely impact our business. If we are unable to keep up with demand for ourproduct by successfully manufacturing and shipping our product in a timely manner, our revenue could be impaired, market acceptance for our productcould be adversely affected and our customers might instead purchase our competitors’ products. In addition, developing manufacturing procedures fornew products would require developing specific production processes for those products. Developing such processes could be time consuming, and anyunexpected difficulty in doing so can delay the introduction of a product. 16Table of Contents We currently perform our tests for our service offering exclusively in one laboratory in the United Kingdom. If this facility or any future facilities or ourequipment are damaged or destroyed, or if we experience a significant disruption in our operations for any reason, our ability to continue to operateour business could be materially harmed. We currently perform our T-SPOT.TB test exclusively in a laboratory facility in Abingdon, England. If this facility or any future facilities are to bedamaged, destroyed or otherwise unable to operate, whether due to fire, floods, hurricanes, storms, tornadoes, other natural disasters, employeemalfeasance, terrorist acts, power outages, or otherwise, or if performance of our laboratory is disrupted for any other reason, we may not be able to performour tests or generate test reports as promptly as our customers expect, or possibly not at all. Building or finding a replacement facility could be difficult,expensive and time consuming and any new laboratory would need to satisfy the various certification, accreditation and licensing requirements to whichour current laboratory facility is subject. If we are unable to perform our tests or generate test reports within a timeframe that meets our customers’expectations, our business, financial results and reputation could be materially harmed. As of December 31, 2018, we maintain insurance coverage totaling $17.1 million against damage to our property and equipment and an additional $44.4million to cover business interruption and research and development restoration expenses, subject to deductibles and other limitations. If we haveunderestimated our insurance needs with respect to an interruption, however, or if an interruption is not subject to coverage under our insurance policies,we may not be able to cover our losses. Even if we cover our losses, our business, financial results and reputation could be materially harmed. Failure in our information technology or storage systems could significantly disrupt our operations and our research and development efforts, whichcould adversely impact our revenue, as well as our research, development and commercialization efforts. Our ability to execute our business strategy depends, in part, on the continued and uninterrupted performance of our information technology, or IT,systems, which support our operations, including our Laboratory Information System, or LIS. Due to the sophisticated nature of the technology we use inour laboratory, we are substantially dependent on our IT systems. IT systems are vulnerable to damage from a variety of sources, includingtelecommunications or network failures, malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some ofour servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionarymeasures we have taken to prevent unanticipated problems that could affect our IT systems, sustained or repeated system failures that interrupt our abilityto generate and maintain data, and in particular to operate our LIS or billing systems, could adversely affect our ability to operate our business. Anyinterruption in the operation of our LIS or other IT systems, due to IT system failures, part failures or potential disruptions in the event we are required torelocate our IT systems within our facility or to another facility could have an adverse effect on our operations. Because our business relies heavily on international operations and revenue, changes in currency exchange rates and our need to convert currenciesmay negatively affect our financial condition and results of operations. Our business relies heavily on our operations outside the United States. For the year ended December 31, 2018, 72% of our total revenue was derived fromsales outside the United States. Because we currently operate in three major regions of the world (the United States, Europe and rest of world, or Europeand ROW, and Asia), our revenue is denominated in multiple currencies. Sales in the United States are denominated in U.S. Dollars. Sales in China aredenominated in U.S. Dollars and sales in Japan are denominated in Yen but, in each case, these sales are made by our U.K.-based legal entity where thePound Sterling is the functional currency. As a result, these sales are subject to remeasurement into Pounds Sterling and then translation into U.S. Dollarswhen we consolidate our financial statements. Sales in Europe are denominated primarily in the Pound Sterling and Euro. As we grow Europe and ROWsales outside the United Kingdom and the European Union countries, or the Euro Zone, whose national currency is the Euro, we will be subject toexchange rate risk from additional currencies. As a result, our exchange rate exposure may change over time as our business practices evolve and couldresult in increased costs or reduced revenue and could affect our actual cash flow. Changes in the relative values of currencies occur regularly and, in someinstances, may have a significant impact on our operating results. We cannot predict with any certainty changes in currency exchange rates or the degreeto which we can effectively mitigate these risks. In addition, the weakening of foreign currencies relative to the U.S. Dollar may require us to reduce prices to allow distributors to maintain profitablebusinesses. As a result, sales and earnings of our products in countries outside the United States may be materially adversely affected by foreign currencyexchange rate fluctuations. A decline in the state of the global economy and financial market conditions could adversely affect our ability to conduct business and our resultsof operations. Global economic and financial market conditions, including disruptions in the credit markets and the threat of or impact of global economic deteriorationmay materially impact our customers and other parties with whom we do business. Such conditions could negatively affect our future sales of ourproducts. A decline in general economic and financial market conditions could materially adversely affect our financial condition and results ofoperations. Specifically, the impact of these volatile and negative conditions may include decreased demand for our products and services, a decrease inour ability to accurately forecast future product trends and demand, and a negative impact on our ability to timely collect receivables from our customers.The foregoing economic conditions may lead to increased levels of bankruptcies, restructurings and liquidations for our customers, scaling back ofresearch and development expenditures, delays in planned projects and shifts in business strategies for many of our customers. Such events could, in turn,adversely affect our business through loss of sales. 17Table of Contents Uncertainty arising from global political events, including as a result of the June 2016 referendum on the United Kingdom’s exit from the EuropeanUnion, could adversely affect our ability to conduct business and our results of operations. On June 23, 2016, the United Kingdom, or U.K., held a non-binding referendum, in which voters approved an exit from the European Union, or E.U.,commonly referred to as “Brexit”. Thereafter, on March 29, 2017, the U.K. formally notified the E.U. of its intention to withdraw pursuant to Article 50 ofthe Treaty of the European Union, which formally initiated the withdrawal procedure. A process of negotiation is currently taking place to determine thefuture terms of the U.K.’s relationship with the E.U., with the U.K. due to exit the E.U. on March 29, 2019. It appears likely that this withdrawal will involve a process of lengthy negotiations between the U.K. and E.U. member states to determine the future termsof the U.K.’s relationship with the E.U. For example, while the U.K. government and the E.U. had negotiated a withdrawal agreement and the E.U. hadapproved such withdrawal agreement, the British Parliament subsequently rejected the withdrawal agreement. As a result, there remains considerableuncertainty around the withdrawal. Failure to obtain parliamentary approval of a negotiated withdrawal agreement would mean that the U.K. would leavethe E.U. on March 29, 2019 with no agreement (a so-called “hard Brexit”). The ongoing negotiations between the U.K. and E.U., could lead to a period ofconsiderable uncertainty and volatility, particularly in relation to U.K. financial and banking markets. There is also a risk that the vote by the U.K. toleave the E.U. could result in other member states re-considering their respective membership in the E.U. Weakening of economic conditions or economicuncertainties tend to harm our business, and if such conditions emerge in the U.K. or in the rest of Europe, it may have a material adverse effect on ouroperations and sales. Although it is unknown what the terms of the U.K.’s future relationship with the E.U. will be, it is possible that there will be greater restrictions on tradebetween the U.K. and E.U. countries and increased regulatory complexities. These changes may adversely affect our operations and financial results. Theannouncement of Brexit also caused significant volatility in global currency markets. The fluctuation of currency exchange rates may expose us to gainsand losses on non U.S. currency transactions and impact the purchasing power of our non U.S. currency customers, causing them to decrease or cancelorders or default on payment. Any global political uncertainty similar to the Brexit referendum could similarly harm our ability to conduct our businessand our results of operations. Changes in U.S. tax law and international trade relations may have a material adverse effect on our business, financial condition and results ofoperations. Changes in laws and policy relating to taxes or trade may have an adverse effect on our business, financial condition and results of operations. Recent taxreforms in the U.S. have resulted in significant changes to preexisting U.S. tax rules and regulations. These changes may trigger an adverse effect on ourbusiness, financial conditions and results of operations. Additionally, the U.S. government may seek to implement more protective trade measures with countries in which we conduct business in, which hasintroduced a great deal of uncertainty regarding trade policies, tariffs and government regulations, which if altered could have the potential to create asignificant adverse effect on trade between the U.S. and other countries. Overall, changes in international trade relations, such as the imposition of orincrease in tariffs or other trade barriers, could materially and adversely impact our costs and reduce the competitiveness of our products. We have in the past and may in the future seek to grow our business through acquisitions of or investments in new or complementary businesses,products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have amaterial adverse effect on our operating results and the value of our ordinary shares. From time to time we expect to consider opportunities to acquire or make investments in other technologies, products and businesses that may enhanceour capabilities, complement our current products or expand the breadth of our product offerings, markets or customer base. Potential and completedacquisitions and strategic investments involve numerous risks, including: ●difficulties in acquiring new products, technologies or businesses that will help our current business; ●difficulties in integrating acquired personnel, technologies, products or business operations; ●issues maintaining uniform standards, procedures, controls and policies; ●unanticipated costs associated with acquisitions; ●diversion of management’s attention from our core business; ●adverse effects on existing business relationships with suppliers and customers; ●risks associated with entering new markets in which we have limited or no experience; ●potential loss of key employees of acquired businesses; and ●increased legal and accounting compliance costs. Further, any acquisitions we undertake in the future could be expensive and time consuming, and may disrupt our ongoing business and preventmanagement from focusing on our operations. If we are unable to manage acquisitions or investments, or integrate any future acquired businesses,products or technologies effectively, our business, results of operations and financial condition may be materially and adversely affected. 18Table of Contents Write-offs related to the impairments of our long-lived assets, including goodwill and indefinite-lived intangible assets may adversely impact ourresults of operations. We have in the past and may in the future need to take write-offs as a result of impairments to certain of our long-lived assets. For example, in the fourthquarter of 2018, due to the Company’s change in focus following the Transaction, we recorded a non-cash impairment charge of $879,000 to write-offcertain intangible assets acquired in conjunction with the 2016 acquisition of Immunetics. In the third quarter of 2017, due to increased competition inthe molecular blood donor screening market for Babesia microti, we recorded a non-cash impairment charge of $11.1 million to write-off certainintangible assets acquired in conjunction with the 2016 acquisition of Imugen. Additionally, in the fourth quarter of 2017, due to a mid-Februarycomplete response letter, or CRL, from FDA regarding the Company’s fourth quarter 2017 submissions in relation to its biological license applications, orBLAs, for the Immunetics Babesia microti blood donor screening assay, the Company recorded an impairment charge of $7.2 million to write-off therelated intangible assets. Further, during the fourth quarter of 2016, we made the strategic decision to end our GoutiFind program. GoutiFind was a blood test designed to allow forearly diagnosis of gout and better inform therapies by measuring the strength of the underlying uric acid induced inflammation. As a result of thisdecision, we recorded a non-cash in-process research and development, or IPR&D, impairment charge of $270,000. Also during the fourth quarter of 2016,we recorded a non-cash IPR&D impairment charge of $1.4 million related to the SpiroFind assay when it was determined that the Boulder IPR&D will notdirectly yield any products. We may incur additional non-cash charges related to impairments of our long-lived assets, including goodwill. We are required to perform periodicimpairment reviews of these assets at least annually. To the extent future reviews conclude that the expected future cash flows generated from our businessactivities are not sufficient to recover the carrying value of these assets, we will be required to measure and record an impairment charge to write-downthese assets to their realizable values and those impairment charges could be equal to the entire carrying value of the assets. Any such write-downs couldadversely impact our operating results. Our business could suffer if we lose the services of, or are unable to attract and retain, key members of our senior management, key advisors or otherpersonnel. We are dependent upon the continued services of key members of our senior management and a limited number of key advisors and personnel. Inparticular, we are highly dependent on the skills and leadership of our Chief Executive Officer, Dr. Peter Wrighton-Smith, and the other members ofmanagement named in the “Management” section elsewhere in this Annual Report. The loss of any one of these individuals, without adequate time tofind a suitable replacement, could disrupt our operations or our strategic plans. Additionally, our future success will depend on, among other things, ourability to continue to hire and retain the necessary qualified scientific, technical, sales, marketing and managerial personnel, for whom we compete withnumerous other companies, academic institutions and organizations. The loss of members of our management team, key advisors or personnel, or ourinability to attract or retain other qualified personnel or advisors, could have a material adverse effect on our business, results of operations and financialcondition. Although all members of our senior management team have entered into agreements that restrict their ability to compete with us for a period oftime after the end of their employment, we may be unable to enforce such restrictive covenants at all or for a sufficient duration of time to preventmembers of our management team from competing with us. Our ability to use net operating losses to offset future taxable income may be subject to substantial limitations. As of December 31, 2018, our available U.S. federal net operating losses, or NOLs, totaled $54.7 million and U.S. state loss carryforwards totaled$50.3 million. The amount of these NOLs remains subject to review and possible adjustment by the Internal Revenue Service and state revenueauthorities, as applicable. NOLs may become subject to an annual limitation if there is a cumulative change in the ownership interest of significantshareholders (or certain shareholder groups) over a three-year period in excess of 50%, in accordance with rules established under Section 382 of theInternal Revenue Code of 1986, as amended, or the Code, and similar state rules (we refer to each as an ownership change). Such an ownership changecould limit the amount of historic NOLs that can be utilized annually to offset future taxable income. The amount of this annual limitation is determinedbased on our value immediately prior to the ownership change. We have completed several financings since our inception, including our most recentpublic offering of ordinary shares that closed on August 18, 2017, that may have resulted in one or more ownership changes under this definition. If we aredeemed to have undergone an ownership change by virtue of these transactions, we may not be able to utilize a material portion of our NOLs even if weattain profitability. Future changes in our share ownership, some of which are outside of our control, could result in additional ownership changes forpurposes of these rules. We are unable to predict future ownership changes or the way an ownership change could limit the use of our NOLs. In addition,recent changes to U.S. tax laws could negatively affect our ability to use net operating losses to offset future taxable income. Unlike in prior years, as of December 31, 2018, we no longer qualified as an “emerging growth company” and will incur significant legal, accountingand other expenses. We have determined that, as of December 31, 2018, the last day of the fiscal year following the fifth anniversary of our initial public offering in November2013, we no longer qualified as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012. Because we no longerqualify as an emerging growth company, and as certain extended transition periods available to emerging growth companies expire, we have becomesubject to additional reporting requirements and standards and accelerated filing deadlines for our periodic reports. For example, we are now subject toenhanced disclosures obligations regarding executive compensation in our periodic reports and proxy statements and requirements to hold a nonbindingadvisory vote on executive compensation. As a result, we have taken steps to implement the systems and processes required to comply with theseadditional requirements and we have incurred significant legal, accounting and other expenses. The failure to successfully maintain the adequacy of our system of internal control over financial reporting could have a material adverse impact onour ability to report our financial results in an accurate and timely manner. Section 404 of the Sarbanes-Oxley Act requires us to evaluate annually the effectiveness of our internal control over financial reporting as of the end ofeach fiscal year and to include a management report assessing the effectiveness of our internal control over financial reporting in our Annual Report onForm 10-K. Section 404 also requires our independent registered public accounting firm to report on our internal control over financial reporting. If wefail to maintain the adequacy of our internal controls, we cannot assure you that we will be able to conclude in the future that we have effective internalcontrol over financial reporting. If we fail to maintain effective internal controls, including remediating any material weaknesses or deficiencies in ourinternal controls, as such standards are modified, supplemented or amended in the future, we could be subject to regulatory actions, civil or criminalpenalties or shareholder litigation. In addition, failure to maintain adequate internal controls could result in financial statements that do not accuratelyreflect our financial condition, results of operations and cash flows. 19Table of Contents Our management's assessment of the effectiveness of our internal control over financial reporting, as of December 31, 2018, identified a material weaknessin our internal controls relating to tax accounting, primarily as a result of a lack of necessary corporate tax resources and ineffective execution of thereview of the tax provision and the deferred tax rollforward. While we intend to take remediation measures to correct this material weakness (whichmeasures are more fully described in Item 9A of this report), we cannot assure that we will not have material weaknesses or significant deficiencies in ourinternal controls in the future. Any failure in the effectiveness of our system of internal control over financial reporting could have a material adverseimpact on our ability to report our financial results in an accurate and timely manner. Risks related to the sale of our U.S. laboratory services business to Quest. We will be subject to business uncertainties and contractual restrictions due to the Transaction. The pursuit of the Transaction and the preparation for the integration of the U.S. laboratory services business with Quest may place a significant burden onour management and internal resources. Any significant diversion of management and employee attention away from our ongoing business and anydifficulties encountered in the transition and integration process with Quest may affect our financial results. Our customers, employees, partners and otherparties may have uncertainties about the effects of the Transaction. In connection with the Transaction, it is possible that some customers and otherpersons with whom we have a business relationship may delay or defer certain business decisions or might decide to seek to terminate, change orrenegotiate their relationship with us as a result of the Transaction. If any of these effects were to occur, it could materially and adversely impact ourrevenue, earnings and cash flows and other business results and financial condition, as well as the market price of our ordinary shares. For more information related to the Transaction, please refer to “Business—Overview”, Note 19. Discontinued operations to our consolidated financialstatements included in this Annual Report, and also to our “Management’s Discussion and Analysis of Financial Condition and Results of Operations”included in this Annual Report. The Purchase Agreement exposes us to contingent liabilities that could have a material adverse effect on our financial condition. We have agreed to indemnify Quest for damages resulting from or arising out of any inaccuracy or breach of our representations, warranties or covenantsin the Purchase Agreement, any and all of our liabilities not assumed by Quest in the Transaction and for certain other matters. Pursuant to the PurchaseAgreement, other than in the case of damages arising out of actual and intentional fraud of an indemnifying party, in no event will we or Quest be requiredto indemnify each other for any damages that exceed the final Transaction purchase price of $170 million. Yet, any event that results in a right for Questto seek indemnity from us could result in a substantial payment from us to Quest and could have a material adverse effect on our financial condition andresults of operations. Litigation may arise in connection with the Transaction, which could be costly, divert management’s attention and otherwise materially harm ourbusiness. Regardless of the outcome of any future litigation related to the Transaction, such litigation may be time-consuming and expensive and may distract ourmanagement from running the day-to-day operations of our business. The litigation costs and diversion of management’s attention and resources toaddress the claims and counterclaims in any litigation related to the Transaction may materially adversely affect our business, financial condition andoperating results. Any litigation related to the Transaction may result in negative publicity or an unfavorable impression of us, which could adverselyaffect the price of our ordinary shares, impair our ability to recruit or retain employees, damage our relationships with our customers and suppliers, orotherwise materially harm our operations and financial performance. Risks related to regulatory and other legal issues. If we fail to comply with extensive regulations of domestic and international regulatory authorities, sales of our T-SPOT.TB test in new markets and thedevelopment and commercialization of any new product candidates could be delayed or prevented. Our existing tests, as well as new tests will be, subject to extensive government regulations related to development, testing, manufacturing andcommercialization in the United States and other countries before we can sell in these markets. The process of obtaining and complying with FDA andother governmental regulatory approvals and regulations is costly, time consuming, uncertain and subject to unanticipated delays. Securing regulatoryapproval for a new product, in the United States and many other countries, typically requires several years. Despite the time and expense exerted,regulatory approval is never guaranteed. We may not be able to obtain FDA or other required regulatory approval and market any further products we maydevelop during the time we anticipate, or at all. We also are subject to the following risks and obligations, among others: ●regulators may refuse to approve an application if they believe that applicable regulatory criteria are not satisfied; ●regulators may require additional testing for safety and effectiveness; ●regulators may interpret data from clinical studies in different ways than we interpret them; ●if regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its distribution; and ●regulators may change their approval policies and/or adopt new regulations that affect our ability to secure approvals for new products, whichwould decrease the chance we would be able to commercialize new diagnostic tests. In addition, some international jurisdictions, such as China, require periodic recertification. Even if we obtain initial certifications from regulatory bodies,we may lose certification after a periodic review. Failure to maintain requisite certifications from regulatory bodies would adversely affect our ability togenerate future revenue and operating income. 20Table of Contents If we or our suppliers fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products, theseproducts could be subject to restrictions or withdrawal from the market. Any product for which we obtain marketing approval in the United States or in international jurisdictions, along with the manufacturing processes, post-approval clinical data and promotional activities for such product, will be subject to continual review and periodic inspections by the FDA and otherregulatory bodies. Furthermore, our suppliers may be subject to similar regulatory oversight, and may not currently be or may not continue to be incompliance with applicable regulatory requirements. Failure by us or one of our suppliers to comply with statutes and regulations administered by theFDA and other regulatory bodies, or failure to take adequate action in response to any observations, could result in, among other things, any of thefollowing enforcement actions: ●warning letters or untitled letters; ●fines and civil penalties; ●unanticipated expenditures for corrective actions; ●delays in approving, or refusal to approve, our products; ●withdrawal or suspension of approval by the FDA or other regulatory bodies; ●product recall or seizures; ●interruption of production; ●operating restrictions; ●injunctions; and ●criminal penalties. If any of these actions were to occur, it could harm our reputation and could cause our product sales and profitability to suffer. Any regulatory approval of a product may also be subject to limitations on the indicated uses for which the product may be marketed. If the FDA oranother regulatory body determines that our promotional materials, training or other activities constitute promotion of an unapproved use, it couldrequest that we cease or modify our training or promotional materials or subject us to regulatory enforcement actions. It is also possible that other federal,state or foreign enforcement authorities might take action if they consider our training or promotional materials to constitute promotion of an unapproveduse, which could result in significant fines or penalties under applicable statutory authorities, such as laws prohibiting false claims for reimbursement. Additionally, we may be required to conduct costly post-market testing, and we will be required to report adverse events and malfunctions related to ourproducts. Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipatedseverity or frequency, manufacturing problems, or failure to comply with regulatory requirements may result in restrictions on such products ormanufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, fines, suspension of regulatory approvals, productseizures, injunctions or the imposition of civil or criminal penalties. Furthermore, the FDA and various other authorities will inspect our facilities and those of our suppliers from time to time to determine whether we are incompliance with regulations relating to the manufacture of diagnostic products, including regulations concerning design, manufacture, testing, qualitycontrol, product labeling, distribution, promotion and record-keeping practices. A determination that we are in material violation of such regulationscould lead to the imposition of civil penalties, including fines, product recalls, product seizures or, in extreme cases, criminal sanctions. We may potentially be subject to product liability claims. The testing, manufacturing and marketing of medical diagnostic tests such as our T-SPOT.TB test entail an inherent risk of product liability claims.Further, providing clinical testing services entails a risk of claims for errors or omissions made by our laboratory staff. Potential liability claims mayexceed the amount of our insurance coverage or may be excluded from coverage under the terms of the policy. As of December 31, 2018, we had productliability insurance of $14.4 million. Our existing insurance will have to be increased in the future if we are successful at introducing new diagnosticproducts and this will increase our costs. Under certain of our customer and license agreements, we have agreed to provide indemnification for productliability claims arising out of the use of our T-SPOT.TB test. In the event that we are held liable for a claim or for damages exceeding the limits of ourinsurance coverage, we may be required to make substantial payments. Regardless of merit or eventual outcome, liability claims may result in: ●decreased demand for our product and product candidates; ●injury to our reputation; ●costs of related litigation; ●substantial monetary awards to patients and others; ●loss of revenue; and ●the inability to commercialize our products and product candidates. Any of these outcomes may have an adverse effect on our consolidated results of operations, financial condition and cash flows, and may increase thevolatility of our share price. 21Table of Contents Our inadvertent or unintentional failure to comply with the complex government regulations concerning privacy of medical and personalinformation could subject us to fines and adversely affect our reputation. Privacy regulations in the U.S. and around the world limit use or disclosure of protected personal information without written authorization or consent,except for permitted purposes outlined in the privacy regulations. The privacy regulations provide for significant fines and other penalties for wrongfuluse or disclosure of protected health information, including potential civil and criminal fines and penalties. We have policies and practices that we believe make us compliant with the privacy regulations. Nevertheless, the documentation and processrequirements of the privacy regulations are complex and subject to interpretation. Failure to comply with the privacy regulations could subject us tosanctions or penalties, loss of business and negative publicity. In the U.S., the privacy regulations establish a “floor” of minimum protection for patients as to their medical information. We are required to comply withboth HIPAA privacy regulations and various state privacy laws. Although the HIPAA statute and regulations do not expressly provide for a private right ofaction, we could incur damages under state laws to private parties for the wrongful use or disclosure of confidential health information or other privatepersonal information. Internationally, virtually every jurisdiction in which we operate has established its own data security and privacy legal frameworkwith which we or our customers must comply, including the General Data Protection Regulation established in the European Union. We may also need tocomply with varying and possibly conflicting privacy laws and regulations in other jurisdictions. As a result, we could face regulatory actions, includingsignificant fines or penalties, adverse publicity and possible loss of business. A disruption in our computer networks, including those related to cybersecurity, could adversely affect our financial performance. Cybersecurity refers to the combination of technologies, processes and procedures established to protect information technology systems and data fromunauthorized access, attack, or damage. We rely on our computer networks and systems, some of which are managed by third parties, to manage and storeelectronic information (including sensitive data such as confidential business information and personally identifiable data relating to employees,customers and other business partners), and to manage or support a variety of critical business processes and activities. Cyber-attacks are increasinglymore common, including in the health care industry. The regulatory environment surrounding information security and privacy is increasinglydemanding, with the frequent imposition of new and changing requirements. Compliance with changes in privacy and information security laws and withrapidly evolving industry standards may result in our incurring significant expense due to increased investment in technology and the development ofnew operational processes. We have not experienced any known attacks on our information technology systems that have resulted in any material system failure, accident or securitybreach to date. However, we may face threats to our networks from unauthorized access, security breaches and other system disruptions. We maintain ourinformation technology systems with safeguard protection against cyber-attacks, including passive intrusion protection, firewalls and virus detectionsoftware. However, these safeguards do not ensure that a significant cyber-attack could not occur. Although we have taken steps to protect the security ofour information systems and the data maintained in those systems, it is possible that our safety and security measures will not prevent the systems’improper functioning or damage or the improper access or disclosure of personally identifiable information such as in the event of cyber-attacks. Security breaches, including physical or electronic break-ins, computer viruses, attacks by hackers and similar breaches can create system disruptions orshutdowns or the unauthorized disclosure of confidential information. If personal information or protected health information is improperly accessed,tampered with or disclosed as a result of a security breach, we may incur significant costs to notify and mitigate potential harm to the affected individuals,and we may be subject to sanctions and civil or criminal penalties if we are found to be in violation of the privacy or security rules under HIPAA or othersimilar federal or state laws protecting confidential personal information. In addition, a cybersecurity breach could hurt our reputation by adverselyaffecting the perception of customers and potential customers of the security of their orders and personal information, subject us to liability claims orregulatory penalties for compromised personal information and could have a material adverse effect on our business, financial condition and results ofoperations. Our use of biological and hazardous materials and waste requires us to comply with regulatory requirements, including environmental, health andsafety laws, regulations and permit requirements and subjects us to significant costs and exposes us to potential liabilities. The handling of materials used in the diagnostic testing process involves the controlled use of biological and hazardous materials and wastes. Theprimary hazardous materials we handle or use include human blood samples and solvents. Our business and facilities and those of our suppliers are subjectto federal, state, local and foreign laws and regulations relating to the protection of human health and the environment, including those governing the use,manufacture, storage, handling and disposal of, and exposure to, such materials and wastes. In addition, under some environmental laws and regulations,we could be held responsible for costs relating to any contamination at our past or present facilities and at third-party waste disposal sites even if suchcontamination was not caused by us. A failure to comply with current or future environmental laws and regulations, including the failure to obtain,maintain or comply with any required permits, could result in severe fines or penalties. Any such expenses or liability could have a significant negativeimpact on our business, results of operations and financial condition. In addition, we may be required to incur significant costs to comply with regulatoryrequirements in the future. 22Table of Contents Our business arrangements with customers are subject to applicable anti-kickback, anti-fraud and abuse and other healthcare laws and regulations. Ifsuch business arrangements fail to comply with these laws and regulations, we could be exposed to criminal sanctions, civil penalties, contractualdamages, reputational harm and diminished profits and future earnings. Healthcare providers and physicians play a primary role in the recommendation and ordering of any product candidates, including our T-SPOT.TB test, forwhich we obtain marketing approval. Our arrangements with customers may expose us to broadly applicable fraud and abuse and other healthcare lawsand regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our product.Restrictions under applicable federal and state healthcare laws and regulations include the following: ●The U.S. federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering,receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or thepurchase, order or recommendation of, any good or service, for which payment may be made under federally funded healthcare programs such asMedicare and Medicaid. This statute has been broadly interpreted to apply to manufacturer arrangements with prescribers, purchasers andformulary managers, among others. Several other countries, including the United Kingdom, have enacted similar anti-kickback, fraud and abuse,and healthcare laws and regulations. ●The U.S. False Claims Act imposes criminal and civil penalties against individuals or entities for knowingly presenting, or causing to bepresented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal anobligation to pay money to the federal government. ●HIPAA imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations,including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable healthinformation. HIPAA also imposes criminal liability for knowingly and willfully falsifying, concealing or covering up a material fact or makingany materially false statement in connection with the delivery of or payment for healthcare benefits, items or services. ●The federal Physician Payment Sunshine Act requirements under the PPACA require manufacturers of drugs, devices, biologics and medicalsupplies to report to HHS information related to payments and other transfers of value made to or at the request of covered recipients, such asphysicians and teaching hospitals, and physician ownership and investment interests in such manufacturers. Payments made to physicians andresearch institutions for clinical trials are included within the ambit of this law. Certain state laws and regulations also require the reporting ofcertain items of value provided to health care professionals. ●Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claimsinvolving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations involve substantial costs.We may be subject to qui tam litigation brought by private individuals on behalf of the government under the U.S. Federal False Claims Act, which wouldinclude claims for up to treble damages. Additionally, it is possible that governmental authorities would conclude that our business practices do notcomply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If ouroperations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significantcivil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, andthe curtailment or restructuring of our operations. Exclusion, suspension and debarment from government funded healthcare programs would significantlyimpact our ability to commercialize, sell or distribute any product. If any of the physicians or other providers or entities with whom we expect to dobusiness are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusionsfrom government funded healthcare programs. We are subject to the U.K. Bribery Act, the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customslaws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties,other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition. Our operations are subject to anti-corruption laws, including the U.K. Bribery Act 2010, or Bribery Act, the U.S. Foreign Corrupt Practices Act, or FCPA,and other anti-corruption laws that apply in countries where we do business. The Bribery Act, FCPA and these other laws generally prohibit us and ouremployees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retainbusiness or gain some other business advantage. We and our commercial partners operate in a number of jurisdictions that pose a high risk of potentialBribery Act or FCPA violations, and we participate in collaborations and relationships with third parties whose actions could potentially subject us toliability under the Bribery Act, FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatoryrequirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted. 23Table of Contents We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of theUnited Kingdom and the United States, and authorities in the European Union, including applicable export control regulations, economic sanctions oncountries and persons, customs requirements and currency exchange regulations, collectively referred to as the Trade Control laws. There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the Bribery Act,the FCPA or other legal requirements, including Trade Control laws. If we violate provisions of the Bribery Act, the FCPA or other anti-corruption laws orTrade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses,which could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation into or audit ofus of any potential violations of the Bribery Act, the FCPA, other anti-corruption laws or Trade Control laws by U.K., U.S. or other authorities couldsubject us to fines or criminal or other penalties, which could have an adverse impact on our reputation, our business, results of operations and financialcondition. Healthcare reform measures could hinder or prevent the commercial success of our diagnostic tests. In March 2010, President Obama signed into law a legislative overhaul of the U.S. healthcare system, the PPACA, which had far-reaching consequencesfor many healthcare companies, including diagnostic companies like us. For example, if reimbursement for our diagnostic tests is substantially less thanwe or our clinical laboratory customers expect, our business could be materially and adversely impacted. However, the future of the PPACA is uncertainand at this juncture there will be a period of uncertainty regarding the PPACA’s repeal, modification or replacement or the effect of the changes made tothe PPACA under the Tax Cuts and Jobs Act of 2017, any of which could have long term financial impact on the delivery of and payment for healthcare inthe U.S. Regardless of the impact of the PPACA on us, the U.S. government and other governments have shown significant interest in pursuing healthcare reformand reducing healthcare costs. Any government-adopted reform measures could cause significant pressure on the pricing of healthcare products andservices, including our T-SPOT.TB test, in the United States and internationally, as well as the amount of reimbursement available from governmentalagencies and other third-party payors. Actual and anticipated changes to the regulations of the healthcare system and U.S. tax laws may have a negative impact on the cost of healthcarecoverage and reimbursement of healthcare services and products. The FDA and comparable agencies in other jurisdictions directly regulate many critical activities of life science, technology, and healthcare industries,including the conduct of preclinical and clinical studies, product manufacturing, advertising and promotion, product distribution, adverse eventreporting, and product risk management. In both domestic and foreign markets, sales of products depend in part on the availability and amount ofreimbursement by third-party payors, including governments and private health plans. Governments may regulate coverage, reimbursement, and pricingof products to control cost or affect utilization of products. Private health plans may also seek to manage cost and utilization by implementing coverageand reimbursement limitations. Substantial uncertainty exists regarding the reimbursement by third-party payors of newly approved healthcare products.The U.S. and foreign governments regularly consider reform measures that affect healthcare coverage and costs. Such reforms may include changes to thecoverage and reimbursement of healthcare services and products. In particular, there have been recent judicial and Congressional challenges to thePPACA, which could have an impact on coverage and reimbursement for healthcare services covered by plans authorized by the PPACA, and we expectthere will be additional challenges and amendments to the PPACA in the future. Attempts to repeal or to repeal and replace the PPACA will likely continue under the current Congress. In addition, various other healthcare reformproposals have emerged at the federal and state level. The recent changes to U.S. tax laws could also negatively impact the PPACA. We cannot predictwhat healthcare initiatives or tax law changes, if any, will be implemented at the federal or state level, however, government and other regulatoryoversight and future regulatory and government interference with the healthcare systems could adversely impact our business. Risks related to our intellectual property. We may be unable to protect or obtain proprietary rights that we utilize or intend to utilize. In developing, manufacturing and using our T-SPOT.TB test, we employ a variety of proprietary and patented technologies, including technologies welicense from third parties. We have licensed, and expect to continue to license, various other technologies and methods. We cannot provide any assurancethat the intellectual property rights that we own or license provide protection from competitive threats or that we would prevail in any challenge mountedto our intellectual property rights. See “Legal Proceedings” for more information. In addition, we cannot provide any assurances that we will be successfulin obtaining and retaining licenses or proprietary or patented technologies in the future. We are unable to predict whether any of our currently pending or future patent applications will result in issued patents, or how long it may take for suchpatents to be issued. Further, we cannot predict whether other parties will challenge any patents issued or licensed to us or that courts or administrativeagencies will hold our patents or the patents we license to be valid and enforceable. We may not be successful in defending challenges made against ourpatents and patent applications. Any successful third-party challenge to our patents could result in the unenforceability or invalidity of such patents. Boththe patent application process and the process of managing patent disputes can be time consuming and expensive. 24Table of Contents The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legalprinciples remain unresolved. No consistent policy regarding the breadth of claims allowed in such companies’ patents has emerged to date in the UnitedStates. Furthermore, in the biotechnology field, courts frequently render opinions that may affect the patentability of certain inventions or discoveries andthe patent positions of companies engaged in development and commercialization of certain diagnostic tests. Various courts, including the U.S. SupremeCourt, have recently rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to genomic diagnostics. Thesedecisions generally stand for the proposition that inventions that recite laws of nature are not themselves patentable unless they have sufficient additionalfeatures that provide practical assurance that the processes are genuine inventive applications of those laws rather than patent drafting efforts designed tomonopolize the law of nature itself. What constitutes a “sufficient” additional feature is uncertain. While we do not generally rely on gene sequencepatents, this evolving case law in the United States may adversely impact our ability to obtain new patents and may facilitate third-party challenges to ourexisting owned and licensed patents. Changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of our intellectualproperty rights. We cannot predict the breadth of claims that may be allowed or enforced in patents we own or in those to which we have license rights.For example: ●the inventor might not have been the first to make the inventions covered by patents we rely on; ●the inventor or his assignee might not have been the first to file patent applications for the claimed inventions; ●others may independently develop similar or alternative products and technologies or duplicate our product and technologies; ●it is possible that the patents we own or license may not provide us with any competitive advantages, or may be challenged and invalidated bythird parties; ●any patents we obtain or license may expire before, or shortly after, the products and services relating to such patents are commercialized; ●we may not develop additional proprietary products and technologies that are patentable; and ●the patents of others may have an adverse effect on our business. In particular, in September 2011, the U.S. Congress passed the Leahy-Smith America Invents Act, or the AIA, which became effective in March 2013. TheAIA reforms U.S. patent law in part by changing the standard for patent approval for certain patents from a “first to invent” standard to a “first to file”standard and developing a post-grant review system. It is too early to determine what the effect or impact the AIA will have on the operation of ourbusiness and the protection and enforcement of our intellectual property. However, the AIA and its implementation could increase the uncertainties andcosts surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a materialadverse effect on our business and financial condition. Some patent applications in the United States may be maintained in secrecy until the patents are issued, other patent applications in the United States andmany foreign jurisdictions are not published until eighteen months after filing, and publications in the scientific literature often lag behind actualdiscoveries. We therefore cannot be certain that others have not filed patent applications for technology covered by issued patents or pendingapplications that we own or license or that we or our licensors, as applicable, were the first to invent the technology (pre-AIA) or first to file (post-AIA).Our competitors may have filed, and may in the future file, patent applications covering technology similar or the same as ours. Any such patentapplication may have priority over patent applications that we own or license and could further require us to obtain rights to such technologies in order tocarry on our business. If another party has filed a U.S. patent application on inventions similar or the same as those that we own or license, we or ourlicensors may have to participate in an interference or other proceeding in the U.S. Patent and Trademark Office, or PTO, or a court to determine priority ofinvention in the United States, for pre-AIA applications and patents. For post-AIA applications and patents, we or our licensors may have to participate ina derivation proceeding to resolve disputes relating to inventorship. The costs of these proceedings could be substantial, and it is possible that suchefforts would be unsuccessful, resulting in a loss of our U.S. patent position with respect to such inventions. Some of our competitors may be able to sustain the costs of complex patent disputes and litigation more effectively than we can because they havesubstantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any disputes or litigation could have amaterial adverse effect on our ability to raise the funds necessary to continue our operations. In addition to pursuing patents on our technology, we seek to protect our intellectual property and proprietary technology by entering into intellectualproperty assignment agreements with our employees, consultants and third-party collaborators. See “We may be unable to adequately prevent disclosureof trade secrets and other proprietary information, or the misappropriation of the intellectual property we regard as our own.” Our intellectual property rights may not be sufficient to protect our competitive position and to prevent others from manufacturing, using or sellingcompeting products. The scope of our owned and licensed intellectual property rights may not be sufficient to prevent others from manufacturing, using or selling competingtests. For example, our intellectual property position depends in part on intellectual property that we license from third parties. However, many of the keypatents we license are expected to expire by 2020. In addition, while many of the licenses we have been granted are exclusive, such rights may be limitedto a narrowly defined field of use. As a result, our competitors may have obtained or be able to obtain a license to the same intellectual property in aclosely related field of use. Finally, we have also granted sublicenses to third parties under certain of the intellectual property that we license. Suchsublicenses may allow third parties or their licensees to market a TB test that would otherwise infringe upon such intellectual property. 25Table of Contents Moreover, competitors could purchase our product and attempt to replicate some or all of the competitive advantages we derive from our developmentefforts, willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologies that falloutside of our intellectual property rights. If our intellectual property is not adequately protected so as to protect our market against competitors’ productsand methods, our competitive position could be adversely affected, as could our business. We depend on certain technologies that are licensed or sublicensed to us. We do not control these technologies and any loss of our rights to them couldprevent us from selling our product. We rely on licenses in order to be able to use various proprietary technologies that are material to our business. We do not own the patents that underliethese licenses. Our rights to use these technologies and employ the inventions claimed in the licensed patents are subject to the continuation of and ourcompliance with the terms of those licenses. In some cases, we do not control the prosecution, maintenance or filing of the patents to which we hold licenses. Enforcement of our licensed patents ordefense of any claims asserting the invalidity of these patents is often subject to the control or cooperation of our licensors. We cannot be certain that ourlicensors will prosecute, maintain, enforce and defend the licensed patent rights in a manner consistent with the best interests of our business. We alsocannot be certain that drafting or prosecution of the licensed patents and patent applications by the licensors have been or will be conducted incompliance with applicable laws and regulations, will result in valid and enforceable patents and other intellectual property rights, or that any issuedpatents or patents that may issue in the future will provide any competitive advantage. Certain of our licenses contain provisions that allow the licensor to terminate the license upon specific conditions. Our rights under each of the licensesare subject to our continued compliance with the terms of the license, including certain diligence, disclosure and confidentiality obligations and thepayment of royalties and other fees. If we were found to be in breach of any of our license agreements, in certain circumstances our licensors may takeaction against us, including termination of the applicable license. Because of the complexity of our product and the patents we have licensed,determining the scope of the license and related obligations can be difficult and can lead to disputes between us and the licensor. An unfavorableresolution of such a dispute could lead to an increase in the royalties payable pursuant to the license or termination of the license. If a licensor believedwe were not paying the royalties due under the license or were otherwise not in compliance with the terms of the license, the licensor may have the right toterminate the license or, in certain circumstances, to convert an exclusive license to a non-exclusive one. If such an event were to occur, the value of ourproduct or product candidates could be materially adversely affected, we might be barred from producing and selling some or all of our products and maybe subject to other liabilities. In addition to the above risks, certain of our licensors do not own certain intellectual property included in the license, but instead have licensed suchintellectual property from a third party, and have granted us a sub-license. As a result, the actions of our licensors or of the ultimate owners of theintellectual property may affect our rights to use our sublicensed intellectual property, even if we are in compliance with all of the obligations under ourlicense agreements. For example, one of our licenses comprises a sublicense to us of certain patent rights owned by a third party that is not our directlicensor. If our licensors were to fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed tous, or should such agreements be terminated or amended, our ability to produce and sell our product and product candidates may be materially harmed.Finally, the legal issues surrounding the treatment of intellectual property licenses in bankruptcy proceedings are complex and may vary from jurisdictionto jurisdiction. We therefore cannot provide assurance that we would not lose some or all of our rights under a license if the applicable licensor wasinvolved in such proceedings. We may become involved in disputes relating to our intellectual property rights, and may need to resort to litigation in order to defend and enforce ourintellectual property rights. In addition, we could face claims that our activities or the manufacture, use or sale of our products infringe the intellectualproperty rights of others, which could cause us to pay substantial damages or licensing fees and limit our ability to sell some or all of our products andservices. Extensive litigation regarding patents and other intellectual property rights has been common in the medical diagnostics industry. Litigation may benecessary to assert infringement claims, enforce patent rights, protect trade secrets or know-how and determine the enforceability, scope and validity ofcertain proprietary rights. Litigation may even be necessary to resolve disputes of inventorship or ownership of proprietary rights. The defense andprosecution of intellectual property lawsuits, PTO interference or derivation proceedings, and related legal and administrative proceedings (e.g., areexamination) in the U.S. and internationally involve complex legal and factual questions. As a result, such proceedings are costly and time consumingto pursue, and their outcome is uncertain. Even if we prevail in such a proceeding, the remedy we obtain may not be commercially meaningful or adequately compensate us for any damages wemay have suffered. If we do not prevail in such a proceeding, certain of our patents could potentially be declared to be invalid, unenforceable or narrowedin scope, or we could otherwise lose valuable intellectual property rights. Similar proceedings involving the intellectual property we license could alsohave an impact on our business. For example, the scope of one of the European patents that we license from Rutgers, The State University of New Jersey,was narrowed as a result of a third-party opposition proceeding before the European Patent Office. The decision is currently under appeal and the outcomeof that appeal may adversely affect our competitive position. Further, if any of our other owned or licensed patents are declared invalid, unenforceable ornarrowed in scope, our competitive position could be adversely affected. 26Table of Contents In addition, our research, development and commercialization activities, including our T-SPOT.TB test, may infringe or be claimed to infringe patents orother intellectual property rights owned by other parties. Certain of our competitors and other companies have substantial patent portfolios, and mayattempt to use patent litigation as a means to obtain a competitive advantage or to extract licensing revenue. The risks of being involved in suchlitigation may also increase as we gain greater visibility as a public company and as we gain commercial acceptance of our products and move into newmarkets and applications for our products. There may also be patents and patent applications that are relevant to our technologies or tests that we are notaware of. For example, certain relevant patent applications may have been filed but not published. If such patents exist, or if a patent issues on any of suchpatent applications, that patent could be asserted against us. In addition to patent infringement claims, we may also be subject to other claims relating tothe violation of intellectual property rights, such as claims that we have misappropriated trade secrets or infringed third-party trademarks. Regardless of merit or outcome, our involvement in any litigation, interference or other administrative proceedings could cause us to incur substantialexpense and could significantly divert the efforts of our technical and management personnel. Any public announcements related to litigation orinterference proceedings initiated or threatened against us could cause our share price to decline. An adverse determination, or any actions we take oragreements we enter into in order to resolve or avoid disputes, may subject us to the loss of our proprietary position or to significant liabilities, or requireus to seek licenses that may include substantial cost and ongoing royalties. Licenses may not be available from third parties, or may not be obtainable onsatisfactory terms. An adverse determination or a failure to obtain necessary licenses may restrict or prevent us from manufacturing and selling ourproducts and offering our services. These outcomes could materially harm our business, financial condition and results of operations. We may not be able to adequately protect our intellectual property outside of the United States. The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companieshave encountered significant problems in protecting and defending such rights in foreign jurisdictions. The legal systems of certain countries, particularlycertain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating tobiotechnology, which could make it difficult for us to stop the infringement of our licensed and owned patents. For example, we are aware that thirdparties, particularly in China, are currently selling TB diagnostic products that we believe are covered by certain patents we license. We do not knowwhether our licensor will take all necessary steps to enforce its patent rights in China or whether it will obtain effective relief to stop the sale of productsthat infringe on its patent rights. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts andattention from other aspects of our business. Additionally, prosecuting and maintaining intellectual property (particularly patent) rights are very costlyendeavors, and for these and other reasons we may not pursue or obtain patent protection in all major markets. We do not know whether legal andgovernment fees will increase substantially and therefore are unable to predict whether cost may factor into our global intellectual property strategy. In addition to the risks associated with patent rights, the laws in some foreign jurisdictions may not provide protection for our trade secrets and otherintellectual property. If our trade secrets or other intellectual property are misappropriated in foreign jurisdictions, we may be without adequate remediesto address these issues. Additionally, we also rely on confidentiality and assignment of invention agreements to protect our intellectual property inforeign jurisdictions. These agreements may provide for contractual remedies in the event of misappropriation, but we do not know to what extent, if any,these agreements and any remedies for their breach, will be enforced by a foreign court. In the event our intellectual property is misappropriated orinfringed upon and an adequate remedy is not available, our future prospects will likely diminish. The sale of products that infringe our intellectualproperty rights, particularly if such products are offered at a lower cost, could negatively impact our ability to achieve commercial success and maymaterially and adversely harm our business. Our failure to secure trademark registrations could adversely affect our business and our ability to market our product and product candidates. Our trademark applications in the United States and any other jurisdictions where we may file may not be allowed for registration, and our registeredtrademarks may not be maintained or enforced. During trademark registration proceedings, we may receive rejections. Although we are given anopportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the PTO and in corresponding foreign agencies,third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellationproceedings may be filed against our applications and/or registrations, and our applications and/or registrations may not survive such proceedings.Failure to secure such trademark registrations in the United States and in foreign jurisdictions could adversely affect our business and our ability to marketour product and product candidates. 27Table of Contents Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and otherrequirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with theserequirements. The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and otherprovisions during the patent prosecution process and following the issuance of a patent. There are situations in which noncompliance with theserequirements can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevantjurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case if our patent were in force. We may be unable to adequately prevent disclosure of trade secrets and other proprietary information, or the misappropriation of the intellectualproperty we regard as our own. We rely on trade secrets to protect our proprietary know-how and technological advances, particularly where we do not believe patent protection isappropriate or obtainable. Nevertheless, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees,consultants, third-party collaborators and other advisors to protect our trade secrets and other proprietary information. These agreements generally requirethat the other party to the agreement keep confidential and not disclose to third parties all confidential information developed by the party or madeknown to the party by us during the course of the party’s relationship with us. These agreements may not effectively prevent disclosure of confidentialinformation and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Monitoring unauthorizeddisclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. If we were to seek topursue a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time consuming, and the outcomewould be unpredictable. Further, courts outside the United States may be less willing to protect trade secrets. In addition, others may independentlydiscover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of ourproprietary rights. In addition, our trade secrets and proprietary information may be misappropriated as a result of breaches of our electronic or physicalsecurity systems in which case we may have no legal recourse. Failure to obtain, or maintain, trade secret protection could enable competitors to use ourproprietary information to develop products that compete with our product or cause additional, material adverse effects upon our competitive businessposition. We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. As is common in the medical diagnostics industry, we employ individuals who were previously employed at other medical diagnostics companies,including our competitors or potential competitors. We may be subject to claims that these employees or we have inadvertently or otherwise used ordisclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if weare successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. Risks related to our ordinary shares. Our share price may be volatile. Like other medical diagnostic companies, the market price of our ordinary shares may be volatile. The factors below may also have a material adverseeffect on the market price of our ordinary shares: ●fluctuations in our results of operations; ●our ability to enter new markets; ●negative publicity; ●changes in securities or industry analyst recommendations regarding our company, the sectors in which we operate, the securities marketgenerally and conditions in the financial markets; ●regulatory developments affecting our industry; ●announcements of studies and reports relating to our products or those of our competitors; ●changes in economic performance or market valuations of our competitors; ●actual or anticipated fluctuations in our quarterly results; ●conditions in the industries in which we operate; ●announcements by us or our competitors of new products, acquisitions, strategic relations, joint ventures or capital commitments; ●additions to or departures of our key executives and employees; ●fluctuations of exchange rates; ●release or expiry of lock-up or other transfer restrictions on our outstanding ordinary shares; and ●sales or perceived sales of additional shares of our ordinary shares. 28Table of Contents In addition, the equity markets have recently experienced significant volatility, particularly with respect to the securities of life sciences companies. Thevolatility of the securities of life sciences companies often does not relate to the operating performance of those companies. As we operate in a singleindustry, we are especially vulnerable to these factors to the extent that they affect our industry or our products, or to a lesser extent our markets. In thepast, securities class action litigation has often been initiated against companies following periods of volatility in their stock price. This type of litigationcould result in substantial costs and divert our management’s attention and resources, and could also require us to make substantial payments to satisfyjudgments or to settle litigation. While we have announced that our Board of Directors has approved a share repurchase program, we cannot guarantee that we will repurchase ourordinary shares pursuant to our share repurchase program or that our share repurchase program will enhance long-term shareholder value. In January 2019, our Board of Directors announced that it would seek the shareholders’ authorization of a share repurchase program. Specifically, theCompany intends to seek the shareholders’ authorization of the purchase of up to $100 million of the Company’s outstanding ordinary shares over a five-year period. The share repurchase program will be presented for shareholder approval on or before our annual general meeting of shareholders on Tuesday,June 18, 2019. Although our Board of Directors has authorized the share repurchase program, the share repurchase program is subject to shareholder approval, andshareholders may not approve our share repurchase program. Even if we receive shareholder approval of our share repurchase program, our sharerepurchase program would not obligate us to repurchase any specific dollar amount or to acquire any specific number of shares. The timing and amount ofrepurchases, if any, will depend upon several factors, including market and business conditions, the trading price of our ordinary shares and the nature ofother investment opportunities. The repurchase program may be limited, suspended or discontinued at any time without prior notice. In addition, repurchases of our ordinary shares pursuant to our share repurchase program could affect our share price and increase its volatility. Theexistence of a share repurchase program could cause our share price to be higher than it would be in the absence of such a program and could potentiallyreduce the market liquidity for our ordinary shares. Additionally, our share repurchase program could diminish our cash reserves, which may impact ourability to finance future growth and to pursue possible future strategic opportunities and acquisitions. There can be no assurance that any sharerepurchases will enhance shareholder value because the market price of our ordinary shares may decline below the levels at which we repurchased sharesof stock. Although our share repurchase program is intended to enhance long-term shareholder value, there is no assurance that it will do so and short-termprice fluctuations in our ordinary shares could reduce the program’s effectiveness. We do not intend to pay cash dividends on our ordinary shares in the foreseeable future. We have never paid dividends on ordinary shares and do not currently anticipate paying any cash dividends on our ordinary shares in the foreseeablefuture. Under English law, any payment of dividends would be subject to relevant legislation and our articles of association, which provide that alldividends must be approved by our Board of Directors and, in some cases, our shareholders, and may only be paid from our distributable profits availablefor the purpose, determined on an unconsolidated basis. Our executive officers, directors, and 5% or greater shareholders and management own a significant percentage of our ordinary shares and will be ableto exercise significant influence over matters subject to shareholder approval. Our executive officers, directors, and 5% or greater shareholders beneficially own a substantial percentage of our ordinary shares. For example, as of April16, 2018, as disclosed in our 2018 Definitive Proxy filed with the SEC on April 27, 2018, our executive officers, directors, and 5% or greater shareholdersand their affiliates beneficially owned approximately 48% of our outstanding ordinary shares in the aggregate. We expect that these shareholders will beable to exert a significant degree of influence over our management and affairs and over matters requiring shareholder approval, including the election ofour Board of Directors and approval of significant corporate transactions. This concentration of ownership could have the effect of entrenching ourmanagement and/or our Board of Directors, delaying or preventing a change in our control or otherwise discouraging a potential acquirer from attemptingto obtain control of us, which in turn could have a material and adverse effect on the fair market value of our ordinary shares. 29Table of Contents Our ordinary shares are listed on The NASDAQ Global Market, but we cannot guarantee that we will be able to satisfy the continued listing standardsgoing forward. Although our ordinary shares are listed on The NASDAQ Global Market, we cannot ensure that we will be able to satisfy the continued listing standards ofThe NASDAQ Global Market going forward. If we cannot satisfy the continued listing standards going forward, The NASDAQ Stock Market maycommence delisting procedures against us, which could result in our ordinary shares being removed from listing on The NASDAQ Global Market. If ourordinary shares were to be delisted, the liquidity of our ordinary shares could be adversely affected and the market price of our ordinary shares coulddecrease. Delisting could also adversely affect our shareholders’ ability to trade or obtain quotations on our shares because of lower trading volumes andtransaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask price for our ordinary shares. Our shareholders mayalso not be able to resell their shares at or above the price paid for such shares or at all. English law and provisions in our articles of association may have anti-takeover effects that could discourage an acquisition of us by others, even if anacquisition would be beneficial to our shareholders, and may prevent attempts by our shareholders to replace or remove our current management. Certain provisions of English law and our articles of association may have the effect of delaying or preventing a change in control of us or changes in ourmanagement. For example, English law and our articles of association include provisions that: ●create a classified Board of Directors whose members serve staggered three-year terms; ●prohibit shareholder action by written resolution; ●establish an advance notice procedure for shareholder approvals to be brought before an annual meeting of our shareholders, including proposednominations of persons for election to our Board of Directors; and ●provide that vacancies on our Board of Directors may be filled only by a majority of directors then in office, even though less than a quorum. These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management. See also “Provisionsin the U.K. City Code on Takeovers and Mergers may have anti-takeover effects that could discourage an acquisition of us by others, even if anacquisition would be beneficial to our shareholders.” Our holding company structure makes us dependent on the operations of our subsidiaries to meet our financial obligations. We are a public limited company organized under the laws of England and Wales and have no significant assets other than our interest in OxfordImmunotec Limited and its subsidiaries. As a result, we rely exclusively upon payments, dividends and distributions from our direct and indirectsubsidiaries for our cash flows. Our ability to pay dividends to our shareholders is dependent on the ability of our subsidiaries to generate sufficient netincome and cash flows to pay upstream dividends and make loans or loan repayments. However, we have never paid dividends on ordinary shares and donot anticipate paying any cash dividends on our ordinary shares in the foreseeable future. Risks related to being an English company listing ordinary shares. U.S. investors may have difficulty enforcing civil liabilities against our company, our directors or members of senior management. We are incorporated under the laws of England and Wales. The rights of holders of our ordinary shares are governed by English law, including theprovisions of the Companies Act 2006, and by our articles of association. These rights differ in certain respects from the rights of shareholders in typicalU.S. corporations organized in Delaware. Many of our directors and officers reside outside the United States, and a substantial portion of our assets and allor a substantial portion of the assets of such persons are located outside the United States. As a result, it may be difficult for you to serve legal process onus or our directors and executive officers or have any of them appear in a U.S. court. The United States and the United Kingdom do not currently have atreaty providing for the recognition and enforcement of judgments, other than arbitration awards, in civil and commercial matters. The enforceability ofany judgment of a U.S. federal or state court in the United Kingdom will depend on the laws and any treaties in effect at the time, including conflicts oflaws principles (such as those bearing on the question of whether a U.K. court would recognize the basis on which a U.S. court had purported to exercisejurisdiction over a defendant). In this context, there is doubt as to the enforceability in the United Kingdom of civil liabilities based solely on the federalsecurities laws of the United States. In addition, awards for punitive damages in actions brought in the United States or elsewhere may be unenforceable inthe United Kingdom. An award for monetary damages under the U.S. securities laws would likely be considered punitive if it did not seek to compensatethe claimant for loss or damage suffered and was intended to punish the defendant. 30Table of Contents Provisions in the U.K. City Code on Takeovers and Mergers may have anti-takeover effects that could discourage an acquisition of us by others, even ifan acquisition would be beneficial to our shareholders. The U.K. City Code on Takeovers and Mergers, or the Takeover Code, applies, among other things, to an offer for a public company whose registeredoffice is in the United Kingdom (or the Channel Islands or the Isle of Man) and whose securities are not admitted to trading on a regulated market in theUnited Kingdom (or the Channel Islands or the Isle of Man) if the company is considered by the Panel on Takeovers and Mergers, or the Takeover Panel,to have its place of central management and control in the United Kingdom (or the Channel Islands or the Isle of Man). This is known as the “residencytest.” The test for central management and control under the Takeover Code is different from that used by the U.K. tax authorities. Under the TakeoverCode, the Takeover Panel will determine whether we have our place of central management and control in the United Kingdom by looking at variousfactors, including the structure of our Board of Directors, the functions of the directors and where they are resident. If at the time of a takeover offer the Takeover Panel determines that we have our place of central management and control in the United Kingdom, wewould be subject to a number of rules and restrictions, including but not limited to the following: (1) our ability to enter into deal protection arrangementswith a bidder would be extremely limited; (2) we might not, without the approval of our shareholders, be able to perform certain actions that could havethe effect of frustrating an offer, such as issuing shares or carrying out acquisitions or disposals; and (3) we would be obliged to provide equality ofinformation to all bona fide competing bidders. If we are a passive foreign investment company, U.S. investors in our ordinary shares could be subject to adverse U.S. federal income tax consequences. The rules governing passive foreign investment companies, or PFICs, can have adverse effects for U.S. federal income tax purposes. The tests fordetermining PFIC status for a taxable year depend upon the relative values of certain categories of assets and the relative amounts of certain kinds ofincome. We do not believe that we are currently a PFIC, and we do not anticipate becoming a PFIC in the foreseeable future. Notwithstanding theforegoing, the determination of whether we are a PFIC depends on the particular facts and circumstances (such as the valuation of our assets, includinggoodwill and other intangible assets) and may also be affected by the application of the PFIC rules, which are subject to differing interpretations. The fairmarket value of our assets is expected to depend, in part, upon (a) the market price of our ordinary shares and (b) the composition of our income and assets,which will be affected by how, and how quickly, we spend any cash that is raised in any financing transaction. In light of the foregoing, no assurance canbe provided that we are not currently a PFIC or that we will not become a PFIC in any future taxable year. If we are a PFIC, U.S. holders of our ordinary shares would be subject to adverse U.S. federal income tax consequences, such as ineligibility for anypreferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reportingrequirements under U.S. federal income tax laws and regulations. Whether or not U.S. holders of our ordinary shares make a timely qualified electing fund,or QEF, election or mark-to-market election may affect the U.S. federal income tax consequences to U.S. holders with respect to the acquisition, ownershipand disposition of our ordinary shares and any distributions such U.S. holders may receive. Investors should consult their own tax advisors regarding allaspects of the application of the PFIC rules to our ordinary shares. U.S. holders of 10% or more of the voting power of our ordinary shares may be subject to U.S. federal income taxation at ordinary income tax rates onundistributed earnings and profits. There is a risk that we will be classified as a controlled foreign corporation, or CFC, for U.S. federal income tax purposes. We will generally be classified asa CFC if more than 50% of our outstanding shares, measured by reference to voting power or value, are owned (directly, indirectly or by attribution) by“U.S. Shareholders.” For this purpose, a “U.S. Shareholder” is any U.S. person that owns directly, indirectly or by attribution, 10% or more of the votingpower of our outstanding shares. If we are classified as a CFC, a U.S. Shareholder may be subject to U.S. income taxation at ordinary income tax rates onall or a portion of our undistributed earnings and profits attributable to “subpart F income” and may also be subject to tax at ordinary income tax rates onany gain realized on a sale of ordinary shares, to the extent of our current and accumulated earnings and profits attributable to such shares. The CFC rulesare complex and U.S. Shareholders of the ordinary shares are urged to consult their own tax advisors regarding the possible application of the CFC rules tothem in their particular circumstances. 31Table of Contents Item 1B. Unresolved Staff Comments None. Item 2. Properties Our U.K. corporate headquarters and manufacturing facility are located in Abingdon, England. We presently lease 8,600 square feet of manufacturing,storage and mixed use space pursuant to a lease that extends through December 31, 2020, or possibly sooner. Our rent for this space is currently $24,500per month. We also rent separate warehouse/storage space in Abingdon, England near our corporate headquarters. The lease on the warehouse/storagespace expires in 2025, and our current rent is $67,000 annually, which is subject to change. In June 2018, the Company entered into a lease for a new space in Abingdon, England, which extends through June 30, 2033, or the 143 Park Lease. The143 Park Lease covers 27,000 square feet of laboratory, office, storage and other mixed use space and will allow us to combine our current manufacturing,laboratory, storage and office operations into a single facility. Initial rent under the 143 Park Lease is approximately $39,000 per month. When the leaseson the Company’s existing facilities have expired and it fully occupies the space subject to the 143 Park Lease, rent will increase to $79,000 per month.Rent will be reviewed for possible increases on June 1, 2021 and every third anniversary after that date. Our U.S. corporate headquarters is located in Marlborough, Massachusetts. In August 2015, we entered into a lease amendment on this location to extendthe term of the lease by two years through October 31, 2020. In addition, beginning in March 2016, the lease amendment expanded our office space at thislocation by 7,600 square feet to a new total of 22,100 square feet. The base rent for the combined space over the lease term will range from an initial lowof $36,000 per month, which includes $12,000 per month for the expansion space commencing in early 2016, to a high of $39,000 per month. We willhave an option to extend the lease for one additional term of five years. We also currently sublease approximately 9,000 square feet of warehousing andoffice space from Quest in Norwood, Massachusetts. The base rent for this space is approximately $17,000 per month. The sublease expires in November2020. Item 3. Legal Proceedings On August 10, 2015, Oxford Immunotec Limited, a wholly-owned subsidiary of Oxford Immunotec Global PLC, filed suit in the United States DistrictCourt for the District of Massachusetts against Qiagen N.V., Qiagen Inc., Quest Diagnostics LLC, and Laboratory Corporation of America Holdingsalleging claims of patent infringement and seeking monetary and injunctive relief. The complaint alleged that the defendants’ manufacture, sale and/oruse of the QuantiFERON-TB Gold test infringes patents owned by Oxford Immunotec Limited. On December 15, 2017, the Company reached a settlement in the lawsuit in the U.S. District Court for the District of Massachusetts in Boston (15-cv-13124-NMG) alleging patent infringement in relation to QIAGEN’s QuantiFERON®-TB Gold and QuantiFERON®-TB Gold Plus products. Under terms ofthe agreement, all pending claims between the Company and QIAGEN and the co-defendants have been resolved. In connection with the settlement, theCompany received a one-time, lump sum payment of $27.5 million from QIAGEN. As part of the settlement, the Company has granted QIAGEN a royalty-free, non-exclusive license that extends to all current and future customers of QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus. The settlementincludes general releases of all parties with no admissions of wrongdoing. Item 4. Mine Safety Disclosures Not applicable. 32Table of Contents PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our ordinary shares trade on the NASDAQ Global Market under the symbol “OXFD.” The price range per share reflected in the table below is the high andlow sales prices of our ordinary shares as reported by NASDAQ (rounded to the nearest penny) for the periods presented. Year endedDecember 31, 2018 Year endedDecember 31, 2017 High Low High Low First quarter $14.70 $10.00 $16.13 $12.96 Second quarter 14.90 12.11 16.90 13.53 Third quarter 19.19 11.66 19.51 14.35 Fourth quarter 17.11 11.88 17.20 12.19 Shareholders On February 28, 2019, there were 10 shareholders of record of our ordinary shares. This number does not include shareholders for whom shares were heldin a “nominee” or “street” name. On February 28, 2018, the last reported sale price per share of our ordinary shares on The NASDAQ Global Market was$16.69. Dividends We have never declared or paid cash dividends on our ordinary shares. We currently do not anticipate paying any cash dividends in the foreseeable future.Any future determination as to the declaration and payment of dividends, if any, will be made at the discretion of our Board of Directors and will dependon then existing conditions, including our results of operations, financial conditions, contractual restrictions, capital requirements, business prospects andother factors our Board of Directors may deem relevant. Under English law, we may pay dividends only out of our accumulated, realized profits, so far asnot previously utilized by distribution or capitalization, less our accumulated, realized losses, so far as not previously written off in a reduction orreorganization of capital duly made. Because we are a holding company and have no direct operations, we will only be able to pay dividends from ouravailable cash on hand and any funds we receive from our subsidiaries. 33Table of Contents The following graph compares the cumulative total shareholder return on our ordinary shares with that of the NASDAQ Composite Index and the S&PSmallcap 600 Healthcare Index. The comparison assumes that $100.00 was invested at the close of market on November 22, 2013 in our ordinary shares oron October 31, 2013 in the NASDAQ Composite Index and the S&P Smallcap 600 Healthcare Index, and assumes reinvestment of dividends, if any. Theperformance graph is based on historical results and is not intended to suggest future performance. This performance graph is being furnished pursuant to SEC rules and will not be incorporated by reference into any filing under the Securities Act or theExchange Act except to the extent we specifically incorporate it by reference. 34Table of Contents Item 6. Selected Consolidated Financial Data The following selected consolidated financial data for the five years ended December 31, 2018 are derived from our consolidated financial statements. On October 2, 2013, we completed a scheme of arrangement under the laws of England and Wales, or the Scheme of Arrangement, which was approved bythe High Court of Justice in England and Wales. Prior to the Scheme of Arrangement, our business was conducted by Oxford Immunotec Limited and itsconsolidated subsidiaries. Following the Scheme of Arrangement, our business has been conducted by Oxford Immunotec Global PLC and itsconsolidated subsidiaries, including Oxford Immunotec Limited. On November 6, 2018, the Company completed an agreement to sell the Company’s U.S. Laboratory Services Business. This agreement represents astrategic business shift having a major effect on the Company’s operations and financial results. Therefore, in accordance with the accounting rules, theoperations of this business have been reported in discontinued operations for all periods presented. We have prepared the unaudited consolidated financial information presented below on the same basis as our audited consolidated financial statements.The unaudited consolidated financial information includes all adjustments, consisting only of normal recurring adjustments that are necessary for a fairpresentation of our financial position and results of operations for these periods. Our historical results are not necessarily indicative of the results that maybe expected in the future. You should read the following selected financial data together with “Management’s discussion and analysis of financialcondition and results of operations” and our financial statements and accompanying notes included elsewhere in this Annual Report on Form 10-K. Theselected financial data in this section are not intended to replace our financial statements and the accompanying notes. Year ended December 31, (in thousands, except share and per share data) 2018(1) 2017(2) 2016 2015 2014 Consolidated statement of operations data: Revenue $59,753 $54,733 $46,988 $38,589 $31,967 Cost of revenue 16,826 18,470 16,491 14,508 7,848 Gross profit 42,927 36,263 30,497 24,081 24,119 Operating expenses: Research and development 8,122 10,835 9,370 7,106 5,560 Sales and marketing 26,500 29,053 26,858 23,242 20,219 General and administrative 25,952 25,450 18,918 14,041 13,665 Change in fair value of contingent purchase price consideration — (3,475) (1,208) 202 72 Intangible assets impairment charges 879 18,300 1,765 419 — Settlement expense 2,193 10,028 — — — Total operating expenses 63,646 90,191 55,703 45,010 39,516 Operating loss from continuing operations (20,719) (53,928) (25,206) (20,929) (15,397)Other (expense) income (4,062) 22,336 (146) (156) (159)Loss from continuing operations before income taxes (24,781) (31,592) (25,352) (21,085) (15,556)Income tax benefit (expense) from continuing operations 37,286 (1,634) 3,774 (146) (154)Income (loss) from continuing operations 12,505 (33,226) (21,578) (21,231) (15,710)Discontinued operations: Income (loss) from discontinued operations before income taxes 1,727 341 (771) (3,247) (6,464)Gain on disposition 145,982 — — — — Income tax expense (39,435) — — — — Income (loss) from discontinued operations 108,274 341 (771) (3,247) (6,464)Net income (loss) $120,779 $(32,885) $(22,349) $(24,478) $(22,174)Net income (loss) per ordinary share—basic Income (loss) from continuing operations $0.48 $(1.40) $(0.97) $(0.97) $(1.14)Income (loss) from discontinued operations 4.17 0.01 (0.03) (0.15) (0.14)Net income (loss) $4.65 $(1.38) $(1.00) $(1.12) $(1.28)Net income (loss) per ordinary share—diluted Income (loss) from continuing operations $0.47 $(1.40) $(0.97) $(0.97) $(1.14)Income (loss) from discontinued operations 4.10 0.01 (0.03) (0.15) (0.14)Net income (loss) $4.58 $(1.38) $(1.00) $(1.12) $(1.28)Weighted-average shares used to compute net income (loss) per ordinaryshare—basic 25,982,809 23,757,902 22,353,713 21,781,933 17,310,148 Weighted-average shares used to compute net income (loss) per ordinaryshare—diluted 26,397,875 23,757,902 22,353,713 21,781,933 17,310,148 35Table of Contents (1)Other income for 2018 includes a $146.0 million gain on the sale of our U.S. Laboratory Services Business to Quest pursuant to a Limited LiabilityCompany Interest Purchase Agreement, from which we received net proceeds of approximately $130.2 million in cash. Upon closing of theTransaction, approximately $32.3 million was paid directly to MidCap Financial Trust, or MidCap, in settlement of all amounts due under our debtfinancing, which was comprised of both a term loan and a revolving line of credit. The payment to MidCap included prepayment and exit fees ofapproximately $2.3 million. (2)Other income for 2017 includes a $27.5 million one-time, lump-sum payment for the settlement of a lawsuit. See Part I, Item 3. Legal Proceedings forfurther information. As of December 31, 2018 2017 2016 2015 2014 Consolidated Balance Sheet Data: Cash and cash equivalents $192,844 $90,332 $59,110 $83,715 $50,165 Total assets 232,120 144,236 124,012 109,852 73,849 Total liabilities 18,114 56,607 51,048 17,160 13,240 Total shareholders’ equity 214,006 87,629 72,964 92,692 60,609 Ordinary shares outstanding 26,439,334 25,661,634 22,635,431 22,549,488 17,614,650 The following table presents a reconciliation of net loss, the most comparable U.S. GAAP measure, to EBITDA and Adjusted EBITDA for each of theperiods indicated: Reconciliation of net income (loss) to Adjusted EBITDA (1)(unaudited) Year Ended December 31, (in thousands) 2018 2017 2016 2015 2014 Reconciliation of net loss to adjusted EBITDA Net income (loss) $120,779 $(32,885) $(22,349) $(24,478) $(22,174)Income (loss) from discontinued operations 108,274 341 (771) (3,247) (6,464)Income (loss) from continuing operations 12,505 (33,226) (21,578) (21,231) (15,710)Income tax (benefit) expense (37,286) 1,634 (3,774) 146 154 Interest expense, net 1,329 2,536 864 67 52 Loss on extinguishment of debt 2,105 — — — — Depreciation and amortization of intangible assets 1,662 1,618 932 1,294 1,036 Accretion and amortization of loan fees 468 569 — — — EBITDA (19,217) (26,869) (23,556) (19,724) (14,468)Reconciling items: Share-based compensation expense 4,507 5,671 4,901 3,400 2,483 Unrealized exchange (gains) losses (1,617) 686 (1,880) (150) (53)Loss on change in fair value of warrants — — — — 22 Change in fair value of contingent purchase price consideration — (3,475) (1,208) 202 72 Intangible assets impairment charges 879 18,300 1,765 419 — Settlement expense 2,193 10,028 — — — Litigation settlement income — (27,500) — — — Transaction expenses 3,333 — — — — Adjusted EBITDA $(9,922) $(23,159) $(19,978) $(15,853) $(11,944) (1)EBITDA and Adjusted EBITDA are non-GAAP measures that we calculate as net income (loss), adjusted for the impact of earnings or chargesresulting from matters that we consider not to be indicative of our ongoing operations. We believe that these measures provide useful information toinvestors in understanding and evaluating our operating results in the same manner as our management and Board of Directors. Our presentation ofthese measures is not made in accordance with U.S. GAAP, and our computation of these measures may vary from others in the industry. Our use ofthese measures has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reportedunder U.S. GAAP. 36Table of Contents Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidatedfinancial statements and the related notes to those statements included elsewhere in this Annual Report on Form 10-K. In addition to our historicalconsolidated financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, beliefs andexpectations. Our actual results and the timing of events could differ materially from those discussed in these forward-looking statements. Factors thatcould cause or contribute to these differences include those discussed below and elsewhere in this Annual Report on Form 10-K, particularly in Part I,Item 1A, “Risk Factors.” As previously disclosed, on September 25, 2018, Oxford Immunotec Global PLC (the “Company”), entered into a Limited Liability Company InterestPurchase Agreement (the “Purchase Agreement”) with Quest Diagnostics Incorporated, a Delaware corporation (“Quest”), Oxford Immunotec Limited, alimited company incorporated in England and Wales and a wholly owned subsidiary of the Company (“Oxford Limited”) and Oxford Immunotec, LLC, aDelaware limited liability company (formerly known as Oxford Immunotec, Inc., a Delaware corporation) and a wholly owned subsidiary of theCompany (“Oxford LLC”), pursuant to which Oxford Limited agreed to sell, and Quest agreed to acquire, the Company’s U.S. laboratory servicesbusiness (the “U.S. Laboratory Services Business”) for gross proceeds of $170 million in cash (the “Transaction”). Of this amount, approximately $32.3million was paid directly to MidCap Financial Trust, or MidCap in settlement of all amounts due. In conjunction with the Transaction, all prior year amounts in this Management’s Discussion and Analysis of Financial Condition and Results ofOperations have been recast to present our results, as if the Transaction had occurred prior to the earliest period presented. For more information on theTransaction, please see the below section entitled “Discontinued operations” and Note 19. Discontinued operations of our notes to consolidatedfinancial statements appearing elsewhere in this Annual Report on Form 10-K. Overview We are a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for immunology and infectious diseaseby leveraging the technological, product development, manufacturing, quality, regulatory, and sales and marketing capabilities we have developed overour sixteen year history. Our proprietary T-SPOT.TB test utilizes our T-SPOT technology platform to test for tuberculosis, which is the leading cause ofinfectious disease death worldwide. On November 6, 2018, we completed the sale of our U.S. Laboratory Services Business to Quest, for gross proceeds of $170 million in cash. ThisTransaction represented a strategic business shift and it had a major effect on our operations and financial results. Following the Transaction, we haveapproximately 210 employees, including sales and marketing teams on three continents, and a laboratory in the United Kingdom. Financial operations overview Revenue We generate revenue mainly from sales associated with our T-SPOT technology platform via our direct sales force and also through distributors. Our T-SPOT.TB test is our first commercialized product based on this technology. We currently offer our T-SPOT.TB test as both an in vitro diagnostic kit and a service. In the former, we sell test kits and associated accessories todistributors for resale and directly to institutions and laboratories that perform TB testing. In the latter, we have an established clinical testing laboratoryin the U.K., where we perform our T-SPOT.TB test on samples sent to us by customers. For the majority of our customers, we primarily negotiate pricingdirectly with our customers; our prices are influenced to some degree by the mechanism and level of funding our customers receive for performing tests forTB infection. In conjunction with the Transaction, the parties entered into certain ancillary agreements as of the Closing Date, including: (i) a transitional servicesagreement, (ii) a technology license agreement and (iii) a long-term supply agreement, or the Supply Agreement, pursuant to which Oxford ImmunotecUSA, Inc., or Oxford USA, agreed to sell, and Quest agreed to purchase, T-SPOT.TB test kits and related accessories from Oxford USA. In addition, theparties entered into a strategic collaboration agreement to drive continued growth of T.SPOT.TB testing in the U.S. Revenue by type By type, total revenues were as summarized in the table below. Year ended December 31, (in thousands) 2018 2017 2016 Revenue Product $54,687 $48,899 $43,070 Service 5,066 5,834 3,918 Total revenue $59,753 $54,733 $46,988 Revenue in the above table includes sales to the U.S. Laboratory Services Business, up to the date of the Transaction, at our intercompany transfer pricethat were formerly eliminated in consolidation. 37Table of Contents Revenue by geography We have a direct sales force in the U.S., certain European countries and Japan and market development personnel in China and South Korea. In parts of theworld where we do not maintain a direct sales force, we market and sell our products through distributors. As a result, our revenue is denominated inmultiple currencies. The following tables reflect revenue by geography (United States, Europe and rest of world, or Europe and ROW, and Asia) and as a percentage of totalrevenue, based on the billing address of our customers. Year ended December 31, (in thousands, except percentages) 2018 2017 2016 Revenue United States $16,442 28% $15,720 29% $10,372 22%Europe and ROW 9,153 15% 8,136 15% 6,988 15%Asia 34,158 57% 30,877 56% 29,628 63%Total revenue $59,753 100% $54,733 100% $46,988 100% Revenue in the above table includes sales to the U.S. Laboratory Services Business, up to the date of the Transaction, at our intercompany transfer pricethat were formerly eliminated in consolidation. Cost of revenue and operating expenses Cost of revenue and gross margin Cost of revenue consists of direct labor expenses, including employee benefits and share-based compensation expenses, overhead expenses, materialcosts, cost of laboratory supplies, freight costs, royalties paid under license agreements, depreciation of laboratory equipment and leaseholdimprovements. We expect our overall cost of revenue to increase as we continue to increase our volume of kits manufactured and tests performed. However, we alsobelieve that through these increased volumes, we can achieve certain efficiencies in our manufacturing and laboratory operations that could help maintainor improve our overall margins. On June 30, 2017, we entered into a Release and Settlement Agreement, or the Settlement Agreement, with Statens Serum Institut, or SSI, to resolveoutstanding disputes arising from the license agreement with SSI. The terms of the Settlement Agreement are confidential. Based on the SettlementAgreement, we no longer expect to pay royalties to SSI, which has improved our margins. On December 19, 2017, the Company amended its licenseagreement with Rutgers, The State University of New Jersey, which reduced our royalties due under the license. This agreement has further improved ourmargins. During the years ended December 31, 2018, 2017 and 2016, our cost of revenue represented 28%, 34% and 35%, respectively, of our total revenue. Year ended December 31, (in thousands) 2018 2017 2016 Cost of revenue Product $13,668 $13,864 $13,807 Service 3,158 4,606 2,684 Total cost of revenue $16,826 $18,470 $16,491 Our gross profit represents total revenue less total cost of revenue, and gross margin is gross profit expressed as a percentage of total revenue. Our grossmargins were 72%, 66% and 65%, respectively, for the years ended December 31, 2018, 2017 and 2016. Research and development expenses Our research and development efforts are focused on development programs to enhance our TB product offering. We are developing multiple productenhancements that aim to improve the clinical utility of our test and improve test workflow and automation. Our research and development activities include performing research, development, clinical and regulatory activities and validating improvements to ourtechnology and processes for the purposes of enhancing product performance. Research and development expenses include personnel-related expenses,including share-based compensation, fees for contractual and consulting services, clinical trial costs, travel costs, laboratory supplies, amortization,depreciation, rent, insurance and repairs and maintenance. We expense all research and development costs as incurred. During the years ended December 31, 2018, 2017 and 2016, our research and development expenses represented 14%, 20% and 20%, respectively, of ourtotal revenue. 38Table of Contents Sales and marketing expenses Our sales and marketing expenses include costs associated with our sales organization, including our direct sales force and sales management, and ourmarketing, customer service and business development personnel. These expenses consist principally of salaries, commissions, bonuses and employeebenefits for these personnel, including share-based compensation, as well as travel costs related to sales, marketing, customer service activities, medicaleducation activities and overhead expenses. We expense all sales and marketing costs as incurred. During the years ended December 31, 2018, 2017 and 2016, our sales and marketing expenses represented 44%, 53% and 57%, respectively, of our totalrevenue. The lower percentage in 2018 reflects lower headcount during the year. General and administrative expenses Our general and administrative expenses include costs for our executive, accounting, treasury, finance, legal, information technology, or IT, and humanresources functions. These expenses consist principally of salaries, bonuses and employee benefits for the personnel included in these functions,including share-based compensation and travel costs, professional services fees, such as consulting, audit, tax and legal fees, costs related to our Board ofDirectors, general corporate costs, overhead expenses, and bad debt expense. Additionally, general and administrative expenses for 2018 include about$3.3 million of costs incurred as a result of the Transaction and a credit of $769,000 for income from the TSA agreement that was entered into inconjunction with the Transaction. We expense all general and administrative expenses as incurred. During the years ended December 31, 2018, 2017 and 2016, our general and administrative expenses represented 43%, 46% and 40%, respectively, of ourtotal revenue. Change in fair value of contingent purchase price consideration During March 2017, as a result of events subsequent to the acquisition of Immunetics, we determined that the timing for FDA approval of the Babesiamicroti product acquired as part of the acquisition would be more likely to occur after the cut-off date for a milestone to be paid. As a result, we recorded a$2.4 million decrease in fair value of contingent purchase price consideration related to the acquisition. The total contingent purchase price considerationof $6.0 million consisted of cash payable on the achievement of certain revenue thresholds and pipeline related milestones over the following three years,including FDA approval of the Babesia microti product by a certain date. The fair value of these milestone payments had been estimated to be $3.4million on the date of acquisition based on significant assumptions, including the probabilities of milestone occurrence, the expected timing of milestonepayments, and a discount rate of 4.4%. As FDA approval did not occur in the second quarter of 2017, the remaining accrual related to this milestone of$238,000 was written-off. In the third quarter of 2017, we determined there to be a remote chance that the revenue thresholds for 2017 would be met andso the remaining contingent consideration liability of $880,000 was written-off. During the fourth quarter of 2016, we made the strategic decision to end our GoutiFind program. GoutiFind was a blood test designed to allow for earlydiagnosis of gout and better inform therapies by measuring the strength of the underlying uric acid induced inflammation. As a result of this decision, wewrote-off the related liability for contingent purchase price consideration in connection with the acquisition of Boulder Diagnostics, Inc., or Boulder, inthe amount of $901,000. During the same quarter, we determined that the SpiroFind assay developed using IPR&D from Boulder would not qualify forfuture milestone payments. Due to this fact, we wrote-off the related contingent purchase price consideration liability of $551,000. Intangible assets impairment charges During the fourth quarter of 2018, in conjunction with our change in focus following the Transaction, we determined that the intangible assets recorded inconjunction with the acquisition of Immunetics in the fourth quarter of 2016 had become impaired. Therefore, we recorded an impairment charge of$879,000 to write them off. In the third quarter of 2017, due to increased competition in the molecular blood donor screening market for Babesia microti, we recorded an impairmentcharge of $11.1 million to write-off certain intangible assets acquired in conjunction with the 2016 acquisition of Imugen. Due to a mid-February CRLfrom FDA regarding the Company’s fourth quarter 2017 submissions in relation to its BLA application for the Immunetics Babesia microti blood donorscreening assay, the Company recorded an impairment charge of $7.2 million to write-off the related intangible assets. During the fourth quarter of 2016, in conjunction with the strategic decision to end our GoutiFind program, we recorded a non-cash IPR&D impairmentcharge of $270,000. Also during the fourth quarter of 2016, we recorded a non-cash in-process research and development, or IPR&D, impairment charge of$1.4 million related to the SpiroFind assay when it was determined that the Boulder IPR&D will not directly yield any products. Settlement expense Settlement expense for 2018 relates mainly to the June 18, 2018 Settlement Agreement with the former shareholders of Immunetics, or the ImmuneticsSettlement Agreement, to resolve disputes arising from the Agreement and Plan of Merger dated October 12, 2016. The terms of the ImmuneticsSettlement Agreement are confidential. 39Table of Contents Settlement expense for 2017 relates to the Settlement Agreement with SSI to resolve outstanding disputes arising from our previous license agreement.The terms of the SSI Settlement Agreement are confidential. Based on the SSI Settlement Agreement, we no longer pay royalties to SSI, which improvesour margins. Interest expense, net Interest expense, net includes interest income on our available cash balances, which are in part invested in money market funds and repurchaseagreements, primarily in U.S. government and agency securities, and bank savings accounts in the United States, United Kingdom, Germany, Japan, Chinaand South Korea. Essentially all our cash is in the U.S. and the U.K. Interest expense mainly relates to our previous agreement with MidCap, or theMidCap agreement, that provided us with $40 million in debt financing, comprised of both a term loan and a revolving line of credit. Loss on extinguishment of debt Upon closing of the sale to Quest in the fourth quarter of 2018, approximately $32.3 million was paid directly to MidCap in settlement of all amountsdue, which included prepayment and exit fees of $2.3 million and accrued interest of $67,000. This prepayment resulted in a loss on extinguishment ofdebt of $2.1 million, representing the cash paid to settle the debt in excess of debt related balances at the time of settlement. Foreign exchange gains (losses) Foreign exchange gains (losses) largely result from U.S. Dollar denominated bank accounts, accounts receivable, and accounts payable reflected on thebooks of Oxford Immunotec Limited, which has a functional currency of the U.K. Pound Sterling. We are exposed to foreign exchange rate risk becausewe currently operate in three major regions of the world: the United States, Europe and ROW, and Asia, and our revenue is denominated in multiplecurrencies. Sales in the United States, China and South Korea are denominated in U.S. Dollars. Sales in Europe are denominated primarily in the U.K.Pound Sterling and Euro. As we grow Europe and ROW sales outside the United Kingdom and the Euro Zone, we may be subject to risk from additionalcurrencies. Sales in Japan are denominated in Yen. Other income (expense) Other income (expense) includes foreign exchange gains/ (losses) and other income and expense items. In addition, in December 2017, the Companyreached a settlement in a lawsuit in exchange for a one-time, lump-sum receipt of $27.5 million. The settlement included general releases of all partieswith no admissions of wrongdoing. Monetary assets and liabilities that are denominated in foreign currencies are remeasured at the period-end closing rate with resulting unrealizedexchange fluctuations. Realized exchange fluctuations result from the settlement of transactions in currencies other than the functional currencies of ourbusinesses. The functional currencies of our businesses are U.S. Dollars, Pounds Sterling, Euros, Japanese Yen and Chinese Yuan, depending on the entity. Income (loss) from discontinued operations On November 6, 2018, we completed an agreement to sell our U.S. Laboratory Services Business to Quest. This agreement represents a strategic businessshift having a major effect on our operations and financial results. Accordingly, the operations of this business have been reported in discontinuedoperations in the consolidated financial statements for all periods presented. Income from discontinued operations for 2018 of $108.3 million includes a$146.0 million gain on the sale. 40Table of Contents Results of operations Comparison of years ended December 31, 2018 and 2017 The following table sets forth, for the periods indicated, the amounts of certain components of our statements of operations and the percentage of totalrevenue represented by these items, showing period-to-period changes. Year ended December 31, 2018 2017 Change (in thousands, except percentages) Amount % ofrevenue Amount % ofrevenue Amount % Revenue: Product $54,687 92% $48,899 89% $5,788 12%Service 5,066 8% 5,834 11% (768) (13)%Total revenue 59,753 100% 54,733 100% 5,020 9% Cost of revenue: Product 13,668 23% 13,864 25% (196) (1)%Service 3,158 5% 4,606 8% (1,448) (31)%Total cost of revenue 16,826 28% 18,470 34% (1,644) (9)%Gross profit 42,927 72% 36,263 66% 6,664 18% Operating expenses: Research and development 8,122 13% 10,835 20% (2,713) (25)%Sales and marketing 26,500 44% 29,053 53% (2,553) (9)%General and administrative 25,952 43% 25,450 46% 502 2%Change in fair value of contingent purchase priceconsideration — —% (3,475) (6)% 3,475 (100)%Intangible assets impairment charge 879 1% 18,300 33% (17,421) (95)%Settlement expense 2,193 4% 10,028 18% (7,835) (78)%Total operating expenses 63,646 107% 90,191 165% (26,545) (29)% Operating loss from continuing operations (20,719) (34)% (53,928) (99)% 33,209 (62)% Interest expense, net (1,797) (3)% (3,105) (6)% 1,308 (42)%Loss on extinguishment of debt (2,105) (4)% — —% (2,105) N/M Foreign exchange gains (losses) 111 0% (1,850) (3)% 1,961 (106)%Other expense (271) (0)% (209) (0)% (62) 30%Litigation settlement income — —% 27,500 50% (27,500) (100)%Loss from continuing operations before income taxes (24,781) (41)% (31,592) (58)% 6,811 (22)%Income tax benefit (expense) from continuing operations 37,286 62% (1,634) (3)% 38,920 N/M Income (loss) from continuing operations 12,505 21% (33,226) (61)% 45,731 N/M Discontinued operations: Income from discontinued operations before income taxes 1,727 3% 341 1% 1,386 406%Gain on disposition 145,982 244% — —% 145,982 N/M Income tax expense (39,435) (66)% — —% (39,435) N/M Income from discontinued operations 108,274 181% 341 1% 107,933 N/M Net income (loss) $120,779 202% $(32,885) (60)% $153,664 N/M 41Table of Contents Revenue Revenue increased by 9% to $59.8 million for the year ended December 31, 2018 compared to $54.7 million for the same period in 2017. U.S. revenue, excluding revenue from discontinued operations, increased by 5%, to $16.4 million for the year ended December 31, 2018, compared to$15.7 million for the same period in 2017. Asia revenue, including revenue from our sales office in South Korea that opened in 2017, increased by 11%, to $34.2 million, compared to the sameperiod in 2017, due primarily to the timing of shipments to China. On a non-Generally Accepted Accounting Principles, or non-GAAP, constant currencybasis, revenue for Asia would have increased by 10%. Europe and ROW revenue increased by 13% to $9.2 million, compared to the same period in 2017.On a non-GAAP constant currency basis, Europe and ROW revenue would have increased by 8% in 2018 compared to 2017. Changes in revenue include the impact of changes in foreign currency exchange rates. We use the non-GAAP financial measure “constant currency basis”in our filings to show changes in our revenue without giving effect to period-to-period currency fluctuations. Under U.S. GAAP, revenues received in local(non-U.S. Dollar) currencies are translated into U.S. Dollars at the average exchange rate for the period presented. When we use the term “constantcurrency basis”, it means that we have translated local currency revenues for the prior reporting period into U.S. Dollars using the same average foreigncurrency exchange rates for the conversion of revenues into U.S. Dollars that we used to translate local currency revenues for the comparable reportingperiod of the current year. We then calculate the change, as a percentage, from the prior period revenues using the current period exchange rates versus thecurrent period revenues. This resulting percentage is a non-GAAP measure referring to a change as a percentage on a “constant currency basis”. Weconsider the use of a period over period revenue comparison on a constant currency basis to be helpful to investors, as it provides a revenue growthmeasure free of positive or negative volatility due to currency fluctuations. By revenue type, total revenues were: Year ended December 31, Change (in thousands, except percentages) 2018 2017 Amount % Revenue Product $54,687 $48,899 $5,788 12%Service 5,066 5,834 (768) (13)%Total revenue $59,753 $54,733 $5,020 9% Revenue in the above table includes sales to the U.S. Laboratory Services Business, up to the date of the Transaction, at our intercompany transfer pricethat were formerly eliminated in consolidation. Overall growth reflects increased TB sales. The decline in service revenue was due to our withdrawal fromthe Babesia testing market. 42Table of Contents By geography, total revenues were: Year ended December 31, Change (in thousands, except percentages) 2018 2017 Amount % Revenue United States $16,442 $15,720 $722 5%Europe and ROW 9,153 8,136 1,017 13%Asia 34,158 30,877 3,281 11%Total revenue $59,753 $54,733 $5,020 9% Revenue in the above table includes sales to the U.S. Laboratory Services Business, up to the date of the Transaction, at our intercompany transfer pricethat were formerly eliminated in consolidation. Cost of revenue and gross margin Cost of revenue decreased by 9% to $16.8 million for the year ended December 31, 2018 from $18.5 million in the same period in 2017. Gross margin for2018 increased to 72% from 66% for 2017. The increase in gross margin reflects the impact of improved accessory margins and lower royalty expense dueto the Settlement Agreement with SSI and the license agreement with Rutgers that was amended in December 2017. Year ended December 31, Change (in thousands, except percentages) 2018 2017 Amount % Cost of revenue Product $13,668 $13,864 $(196) (1)%Service 3,158 4,606 (1,448) (31)%Total cost of revenue $16,826 $18,470 $(1,644) (9)% Research and development expenses Research and development expenses decreased to $8.1 million for the year ended December 31, 2018 from $10.8 million for the same period in 2017. Thedecrease was largely due to lower clinical costs and consulting costs. Additionally, costs in 2017 were higher due to our efforts related to BLAs for threeBabesia microti blood donor screening assays. Our efforts in this area ended in early 2018 following receipt of two BLA approvals for Imugen assays inMarch 2018 (Arrayed Fluorescence Immunoassay and Nucleic acid Amplification Test), and receipt of a CRL from FDA for our Immunetics BLA inFebruary 2018, which raised a number of questions related to our submissions in the fourth quarter of 2017 in support of licensure. As a percentage of totalrevenue, research and development expenses declined to 13% for the year ended December 31, 2018 compared to 20% for the same period in 2017. Sales and marketing expenses Sales and marketing expenses decreased to $26.5 million for the year ended December 31, 2018 from $29.1 million for the same period in 2017. Thedecrease was largely due to lower salary and other employee related expenses and a decrease in marketing costs. As a percentage of total revenue, salesand marketing expenses declined to 44% for the year ended December 31, 2018 compared to 53% for the same period in 2017. General and administrative expenses General and administrative expenses increased to $26.0 million for the year ended December 31, 2018 from $25.5 million for the same period in 2017.The increase in general and administrative expenses largely reflected $3.3 million of costs incurred as a result of the Transaction for the year endedDecember 31, 2018. This increase was partially offset by a decrease in legal fees for a patent infringement action against Qiagen that was settled inDecember 2017. Legal fees of $5.1 million were incurred for this action in 2017 and declined to $1.8 million in 2018. Change in fair value of contingent purchase price consideration During March 2017, as a result of events subsequent to the acquisition of Immunetics, we determined that the timing for FDA approval of the Babesiamicroti product acquired as part of the acquisition would be more likely to occur after the cut-off date for a milestone to be paid. As a result, we recorded a$2.4 million decrease in fair value of contingent purchase price consideration related to the acquisition. The total contingent purchase price considerationof $6.0 million consisted of cash payable on the achievement of certain revenue thresholds and pipeline related milestones over the following three years,including FDA approval of the Babesia microti product by a certain date. The fair value of these milestone payments had been estimated to be $3.4million on the date of acquisition based on significant assumptions, including the probabilities of milestone occurrence, the expected timing of milestonepayments, and a discount rate of 4.4%. As FDA approval did not occur in the second quarter of 2017, the remaining accrual related to this milestone of$238,000 was written-off at that time. In the third quarter of 2017, we determined there to be a remote chance that the revenue thresholds for 2017 wouldbe met and so the remaining contingent consideration liability of $880,000 was written-off. 43Table of Contents Intangible assets impairment charges During the fourth quarter of 2018, in conjunction with our change in focus following the Transaction, we determined that the intangible assets recorded inconjunction with the acquisition of Immunetics in the fourth quarter of 2016 had become impaired. Therefore, we recorded an impairment charge of$879,000 to write them off. In the third quarter of 2017, due to increased competition in the molecular blood donor screening market for Babesia microti, we recorded an impairmentcharge of $11.1 million to write-off certain intangible assets acquired in conjunction with the 2016 acquisition of Imugen. Due to a mid-February CRLfrom FDA regarding the Company’s fourth quarter 2017 submissions in relation to its BLA for the Immunetics Babesia microti blood donor screeningassay, the Company recorded an impairment charge of $7.2 million to write-off the related intangible assets. Settlement expense Settlement expense for 2018 relates mainly to the Immunetics Settlement Agreement. The terms of the Immunetics Settlement Agreement are confidential.Settlement expense for 2017 relates to the SSI Settlement Agreement. The terms of the SSI Settlement Agreement are confidential. Interest expense, net Interest expense, net was $1.8 million for the year ended December 31, 2018, compared to $3.1 million in the same period in 2017. Interest expense, netconsists of our previous MidCap agreement that provided us with $40 million in debt financing, comprised of both a term loan and a revolving line ofcredit, offset by interest income received on our short-term investments. Loss on extinguishment of debt Upon closing of the sale to Quest in the fourth quarter of 2018, approximately $32.3 million was paid directly to MidCap in settlement of all amountsdue, which included prepayment and exit fees of $2.3 million and accrued interest of $67,000. This prepayment resulted in a loss on extinguishment ofdebt of $2.1 million, representing the cash paid to settle the debt in excess of debt related balances at the time of settlement. Foreign exchange (losses) gains We recorded foreign exchange gains of $111,000 for the year ended December 31, 2018, substantially all as a net result of U.S. Dollar denominated bankaccounts, accounts receivable, and accounts payable reflected on the books of Oxford Immunotec Limited, which has a functional currency of the U.K.Pound Sterling. For the year ended December 31, 2017, we recorded foreign exchange losses of $1.9 million. We are exposed to foreign exchange rate riskbecause we currently operate in three major regions of the world: the United States, Europe and ROW, and Asia, and our revenue is denominated inmultiple currencies. Approximately 29% of our sales for the year ended December 31, 2018 were in the United States, which are denominated in U.S.Dollars. Sales in China and South Korea are also denominated in U.S. Dollars. Sales in Europe are denominated primarily in the U.K. Pound Sterling andthe Euro. As we grow Europe and ROW sales outside the United Kingdom and the Euro Zone, we may be subject to risk from additional currencies. Salesin Japan are denominated in Yen. Our expenses are generally denominated in the currencies in which our operations are located, which are primarily in the United States, the UnitedKingdom, Japan, Europe, China and South Korea. As we continue to grow our business outside the United States, our results of operations and cash flowswill be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. To date, we have notentered into any foreign currency hedging contracts, although we may do so in the future. Other expense Other expense was $271,000 for the year ended December 31, 2018, compared to $209,000 in the same period in 2017. Litigation settlement income In December 2017, the Company reached a settlement in a lawsuit in exchange for a one-time, lump-sum receipt of $27.5 million. The settlement includedgeneral releases of all parties with no admissions of wrongdoing. Income (loss) from discontinued operations Discontinued operations represent the U.S. Laboratory Services Business that we sold to Quest on November 6, 2018. For financial statement purposes, thenet assets and results of operations for the discontinued operations have been segregated from those of our continuing operations for all periods presentedand are presented in our consolidated financial statements as discontinued operations. There was income from discontinued operations of $108.3 million for the year ended December 31, 2018, which included a gain on disposition of $146.0million, compared to income from discontinued operations for the year ended December 31, 2017 of $341,000. 44Table of Contents Comparison of years ended December 31, 2017 and 2016 The following table sets forth, for the periods indicated, the amounts of certain components of our statements of operations and the percentage of totalrevenue represented by these items, showing period-to-period changes. Year ended December 31, 2017 2016 Change (in thousands, except percentages) Amount % ofrevenue Amount % ofrevenue Amount % Revenue: Product $48,899 89% $43,070 92% $5,829 14%Service 5,834 11% 3,918 8% 1,916 49%Total revenue 54,733 100% 46,988 100% 7,745 16% Cost of revenue: Product 13,864 25% 13,807 29% 57 0%Service 4,606 8% 2,684 6% 1,922 72%Total cost of revenue 18,470 34% 16,491 35% 1,979 12%Gross profit 36,263 66% 30,497 65% 5,766 19% Operating expenses: Research and development 10,835 20% 9,370 20% 1,465 16%Sales and marketing 29,053 53% 26,858 57% 2,195 8%General and administrative 25,450 46% 18,918 40% 6,532 35%Change in fair value of contingent purchase priceconsideration (3,475) (6)% (1,208) (3)% (2,267) 188%Intangible assets impairment charges 18,300 33% 1,765 4% 16,535 937%Settlement expense 10,028 18% — 0% 10,028 N/M Total operating expenses 90,191 165% 55,703 119% 34,488 62% Operating loss from continuing operations (53,928) (99)% (25,206) (54)% (28,722) 114% Interest expense, net (3,105) (6)% (864) (2)% (2,241) 259%Foreign exchange (losses) gains (1,850) (3)% 1,364 3% (3,214) (236)%Other expense (209) (0)% (646) (1)% 437 (68)%Litigation settlement income 27,500 50% — 0% 27,500 N/M Loss from continuing operations before income taxes (31,592) (58)% (25,352) (54)% (6,240) 25%Income tax (expense) benefit from continuing operations (1,634) (3)% 3,774 8% (5,408) (143)%Loss from continuing operations (33,226) (61)% (21,578) (46)% (11,648) 54%Discontinued operations: Income (loss) from discontinued operations before incometaxes 341 1% (771) (2)% 1,112 144%Income tax expense — —% — —% — —%Income (loss) from discontinued operations 341 1% (771) (2)% 1,112 144%Net loss $(32,885) (60)% $(22,349) (48)% $(10,536) 47% 45Table of Contents Revenue Revenue increased by 16% to $54.7 million for the year ended December 31, 2017 compared to $47.0 million for the same period in 2016. This increasein revenue was mainly due to an increase in volumes across all regions where we sell our T-SPOT.TB test. U.S. revenue grew by 52%, to $15.7 million for the year ended December 31, 2017, compared to $10.4 million for the same period in 2016. Asia revenue, including revenue from our sales office in South Korea that opened in 2017, grew by 4%, to $30.9 million, compared to the same period in2016, due primarily to an increase in volumes that led to higher revenue. On a non-Generally Accepted Accounting Principles, or non-GAAP, constantcurrency basis, revenue for Asia would have increased by 6%. Europe and ROW revenue increased by 16% to $8.1 million, compared to the same periodin 2016. On a non-GAAP constant currency basis, Europe and ROW revenue would have increased by 17% in 2017 compared to 2016. Changes in revenue include the impact of changes in foreign currency exchange rates. We use the non-GAAP financial measure “constant currency basis”in our filings to show changes in our revenue without giving effect to period-to-period currency fluctuations. Under U.S. GAAP, revenues received in local(non-U.S. Dollar) currencies are translated into U.S. Dollars at the average exchange rate for the period presented. When we use the term “constantcurrency basis”, it means that we have translated local currency revenues for the prior reporting period into U.S. Dollars using the same average foreigncurrency exchange rates for the conversion of revenues into U.S. Dollars that we used to translate local currency revenues for the comparable reportingperiod of the current year. We then calculate the change, as a percentage, from the prior period revenues using the current period exchange rates versus thecurrent period revenues. This resulting percentage is a non-GAAP measure referring to a change as a percentage on a “constant currency basis”. Weconsider the use of a period over period revenue comparison on a constant currency basis to be helpful to investors, as it provides a revenue growthmeasure free of positive or negative volatility due to currency fluctuations. By revenue type, total revenues were: Year ended December 31, Change (in thousands, except percentages) 2017 2016 Amount % Revenue Product $48,899 $43,070 $5,829 14%Service 5,834 3,918 1,916 49%Total revenue $54,733 $46,988 $7,745 16% Revenue in the above table includes sales to the U.S. Laboratory Services Business, up to the date of the Transaction, at our intercompany transfer pricethat were formerly eliminated in consolidation. 46Table of Contents By geography, total revenues were: Year ended December 31, Change (in thousands, except percentages) 2017 2016 Amount % Revenue United States $15,720 $10,372 $5,348 52%Europe and ROW 8,136 6,988 1,148 16%Asia 30,877 29,628 1,249 4%Total revenue $54,733 $46,988 $7,745 16% United States revenue in the above table includes sales to the U.S. Laboratory Services Business, up to the date of the Transaction, at our intercompanytransfer price that were formerly eliminated in consolidation. Cost of revenue and gross margin Cost of revenue increased by 12% to $18.5 million for the year ended December 31, 2017 from $16.5 million in the same period in 2016. Gross margin for2017 increased to 66% from 65% for 2016. The increase in gross margin reflects lower royalty expense due to the Settlement Agreement with SSI and thelicense agreement with Rutgers that was amended in December 2017. Year ended December 31, Change (in thousands, except percentages) 2017 2016 Amount % Cost of revenue Product $13,864 $13,807 $57 0%Service 4,606 2,684 1,922 72%Total cost of revenue $18,470 $16,491 $1,979 12% Research and development expenses Research and development expenses increased by 16% to $10.8 million for the year ended December 31, 2017 from $9.4 million for the same period in2016. As a percentage of total revenue, research and development expenses remained relatively constant at 20% for each of the periods ended December31, 2017 and 2016. Sales and marketing expenses Sales and marketing expenses increased 8% to $29.1 million for the year ended December 31, 2017 from $26.9 million for the same period in 2016. As apercentage of total revenue, sales and marketing expenses decreased to 53% for the year ended December 31, 2017 from 57% for the same period in 2016. General and administrative expenses General and administrative expenses increased by 35% to $25.5 million for the year ended December 31, 2017 from $18.9 million for the same period in2016. The increase in general and administrative expenses included increases in legal and professional fees, largely related to patent litigation. As apercentage of total revenue, general and administrative expenses increased to 46% for the year ended December 31, 2017 from 40% for the same period in2016. Change in fair value of contingent purchase price consideration During March 2017, as a result of events subsequent to the acquisition of Immunetics, we determined that the timing for FDA approval of the Babesiamicroti product acquired as part of the acquisition would be more likely to occur after the cut-off date for a milestone to be paid. As a result, we recorded a$2.4 million decrease in fair value of contingent purchase price consideration related to the acquisition. The total contingent purchase price considerationof $6.0 million consisted of cash payable on the achievement of certain revenue thresholds and pipeline related milestones over the following three years,including FDA approval of the Babesia microti product by a certain date. The fair value of these milestone payments had been estimated to be $3.4million on the date of acquisition based on significant assumptions, including the probabilities of milestone occurrence, the expected timing of milestonepayments, and a discount rate of 4.4%. As FDA approval did not occur in the second quarter of 2017, the remaining accrual related to this milestone of$238,000 was written-off at that time. In the third quarter of 2017, we determined there to be a remote chance that the revenue thresholds for 2017 wouldbe met and so the remaining contingent consideration liability of $880,000 was written-off. During the fourth quarter of 2016, we made the strategic decision to end our GoutiFind program. GoutiFind was a blood test designed to allow for earlydiagnosis of gout and to better inform therapies by measuring the strength of underlying uric acid induced inflammation. As a result of this decision, wewrote-off the related liability for contingent purchase price consideration in connection with the Boulder acquisition in the amount of $901,000. Duringthe same quarter, we determined that the SpiroFind assay developed using IPR&D from Boulder would not qualify for future milestone payments. Due tothis fact, we wrote-off the related liability for contingent purchase price consideration of $551,000. The combined credit of $1.5 million was partiallyoffset by a charge of $244,000 related to the change in the fair value of contingent purchase price consideration related to the Boulder and Immuneticsacquisitions. 47Table of Contents Intangible assets impairment charges In the third quarter of 2017, due to increased competition in the molecular blood donor screening market for Babesia microti, we recorded an impairmentcharge of $11.1 million to write-off certain intangible assets acquired in conjunction with the 2016 acquisition of Imugen. Due to a mid-February CRLfrom FDA regarding the Company’s fourth quarter 2017 submissions in relation to its BLA for the Immunetics Babesia microti blood donor screeningassay, the Company recorded an impairment charge of $7.2 million to write-off the related intangible assets. During the fourth quarter of 2016, in conjunction with the strategic decision to end our GoutiFind program, we recorded a non-cash IPR&D impairmentcharge of $270,000. Also during the fourth quarter of 2016, we recorded a non-cash IPR&D impairment charge of $1.4 million related to the SpiroFindassay when it was determined that the Boulder IPR&D would not directly yield any products. Settlement expense Settlement expense for the year ended December 31, 2017 related to the Settlement Agreement with SSI to resolve outstanding disputes arising from ourprevious license agreement. The terms of the Settlement Agreement are confidential. Interest expense, net Interest expense, net was $3.1 million for the year ended December 31, 2017, compared to $864,000 in the same period in 2016. The increase in interestexpense in 2017 mainly related to the Midcap agreement that provided us with $40 million in debt financing, comprised of both a term loan and arevolving line of credit. The MidCap agreement provided a term loan of $30 million, which was to mature five years from closing. The term loan accruedinterest at a rate of LIBOR plus 7.60% with interest only payments for the first 24 months, with the ability to extend to 48 months subject to certainconditions, before the loan was to begin to amortize. The MidCap agreement also provided a revolving line of credit of up to $10 million, which was tomature five years from closing. The revolving line of credit accrued interest at a rate of LIBOR plus 4.45%. Based on certain conditions, both the termloan and revolving line of credit could have been increased by an additional $10 million for a total of $60 million. We never borrowed under therevolving line of credit. Foreign exchange (losses) gains We recorded foreign exchange losses of $1.9 million for the year ended December 31, 2017, substantially all as a net result of U.S. Dollar denominatedbank accounts, accounts receivable and accounts payable reflected on the books of Oxford Immunotec Limited, which has a functional currency of theU.K. Pound Sterling. For the year ended December 31, 2016, we recorded foreign exchange gains of $1.4 million. We have been exposed to foreignexchange rate risk because we operate in three major regions of the world: the United States, Europe and ROW and Asia, and our revenue is denominatedin multiple currencies. Approximately 28% of our sales for 2017 were in the United States, which are denominated in U.S. Dollars. Sales in China andSouth Korea are also denominated in U.S. Dollars. Sales in Europe are denominated primarily in the U.K. Pound Sterling and the Euro. As we grow Europeand ROW sales outside the United Kingdom and the Euro Zone, we may be subject to risk from additional currencies. Sales in Japan are denominated inYen. Our expenses are generally denominated in the currencies in which our operations are located, which are primarily in the United States, the UnitedKingdom, Japan, Europe, China and South Korea. As we continue to grow our business outside the United States, our results of operations and cash flowswill be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. To date, we have notentered into any foreign currency hedging contracts, although we may do so in the future. Other expense Other expense was $209,000 for the year ended December 31, 2017, compared to $646,000 in the same period in 2016, which included a fixed assetimpairment charge of $306,000. Litigation settlement income In December 2017, the Company reached a settlement in a lawsuit in exchange for a one-time, lump-sum receipt of $27.5 million. The settlement includedgeneral releases of all parties with no admissions of wrongdoing. Income (loss) from discontinued operations Discontinued operations represent the U.S. Laboratory Services Business that we sold to Quest on November 6, 2018. For financial statement purposes,results of operations for the discontinued operations have been segregated from those of our continuing operations and are presented in our consolidatedfinancial statements as discontinued operations. There was income from discontinued operations of $341,000 for the year ended December 31, 2017, compared to a loss from discontinued operations forthe year ended December 31, 2016 of $771,000. 48Table of Contents Liquidity and capital resources Sources of funds Since our inception, we have incurred significant net losses and negative cash flows from operations. However, for the year ended December 31, 2018 wehad income from continuing operations of $12.5 million, largely relating to a tax benefit recorded in conjunction with the Transaction, while using$32.1 million of cash for operating activities. As of December 31, 2018, we had an accumulated deficit of $80.8 million. We incurred a loss fromcontinuing operations of $33.2 million and used $13.1 million of cash for operating activities from continuing operations for the year endedDecember 31, 2017. On November 6, 2018, we completed the sale of our U.S. Laboratory Services Business to Quest, for gross proceeds of $170 million in cash. We receivednet proceeds of approximately $130.2 million in cash. In conjunction with the closing of the Transaction, approximately $32.3 million was paid directlyto MidCap in settlement of all amounts due under our debt financing, which was comprised of both a term loan and a revolving line of credit. Thepayment to MidCap included prepayment and exit fees of approximately $2.3 million. On August 14, 2017, we entered into an underwriting agreement, or the Underwriting Agreement, with BTIG, LLC, as sole underwriter, or the Underwriter,relating to the issuance and sale of 2,500,000 ordinary shares, nominal value £0.006705 per share, or the Ordinary Shares, at a price to the public of$16.05 per share, or the Offering, which resulted in approximately $39.3 million of net proceeds to us after deducting underwriting discounts andestimated offering expenses. The Offering closed on August 18, 2017. As of December 31, 2018, we had cash and cash equivalents of $192.8 million. We maintain our available cash balances in cash, money market funds andrepurchase agreements primarily invested in U.S. government and agency securities, and bank savings accounts in the United States, United Kingdom,Germany, Japan, China and South Korea. Essentially all our cash is in the U.S. and the U.K. Settlement agreement Settlement expense for 2018 relates mainly to Immunetics Settlement Agreement. The terms of the Immunetics Settlement Agreement are confidential.Settlement expense for 2017 relates to the Settlement Agreement with SSI to resolve outstanding disputes arising from our previous license agreement.The terms of the SSI Settlement Agreement are confidential. Based on the SSI Settlement Agreement, we no longer pay royalties to SSI. Summary of cash flows The following table summarizes our cash and cash equivalents, accounts receivable and cash flows for the periods indicated: As of and for the years endedDecember 31, (in thousands) 2018 2017 Cash and cash equivalents, including restricted cash $192,944 $90,532 Accounts receivable, net 9,158 6,021 Net cash used in operating activities from continuing operations $(32,119) $(13,122)Net cash used in investing activities from continuing operations (5,350) (1,295)Net cash (used in) provided by financing activities (29,307) 39,386 Net operating cash flows provided by discontinued operations 14,729 9,548 Net investing cash flows provided by (used in) discontinued operations 156,218 (3,734)Net financing cash flows used in discontinued operations (48) (12)Effect of exchange rate changes on cash and cash equivalents, including restricted cash (1,711) 451 Net increase in cash and cash equivalents, including restricted cash $102,412 $31,222 Cash flows for the years ended December 31, 2018 and 2017 Operating activities from continuing operations Net cash used in operating activities from continuing operations was $32.1 million during the year ended December 31, 2018, which included net incomeof $12.5 million, a net credit from non-cash items of $29.2 million, and cash used for changes in operating assets and liabilities of $15.4 million. The non-cash items included a credit related to deferred income taxes of $38.8 million, partially offset by share-based compensation expense of $4.5 million,accretion and amortization of loan fees of $2.4 million, depreciation and amortization of intangible assets of $1.7 million, an intangible assets impairmentcharge of $879,000, and a loss on disposal of property and equipment of $115,000. The cash used for changes in operating assets and liabilities includeda decrease in accounts payable and accrued liabilities of $7.1 million, a decrease in other liabilities of $4.2 million, an increase in accounts receivable of$3.4 million, and an increase in inventory of $1.0 million, partially offset by a decrease in prepaid expenses and other assets of $207,000. The decrease inaccounts payable and accrued liabilities was largely due to payments in 2018 for royalties on intellectual property and bonuses that were accrued for atDecember 31, 2017, as well as the timing of payments. The decrease in other liabilities reflects the timing of payments. The increase in accountsreceivable reflects the timing of customer payments. The increase in inventory was due to timing. The decrease in prepaid expenses and other assetsreflects the timing of certain payments. 49Table of Contents Net cash used in operating activities from continuing operations was $13.1 million during the year ended December 31, 2017, which included a net lossof $33.2 million, net non-cash expenses of $24.6 million and cash used in changes in operating assets and liabilities of $4.5 million. The non-cash itemsconsisted of intangible assets impairments charges of $18.3 million, share-based compensation expense of $5.7 million, depreciation and amortizationexpense of $1.6 million, a decrease in deferred tax assets of $1.6 million, accretion and amortization of loan fees expense of $569,000, and a $298,000loss on disposal of property and equipment. Partially offsetting these charges was a credit for the change in fair value of contingent purchase priceconsideration of $3.5 million. The cash used in operating assets and liabilities included a decrease in accounts payable and accrued liabilities of $5.0million, an increase in inventory of $1.8 million and an increase in accounts receivable of $988,000 million, partially offset by an increase in otherliabilities of $3.7 million. The decrease in accounts payable and accrued liabilities reflects the timing of certain payments. Inventory increased due totiming. The increase in accounts receivable reflects growing sales. The increase in other liabilities is mainly due to the long-term portion of the settlementwith SSI. Investing activities from continuing operations Net cash used in investing activities from continuing operations was $5.4 million during the year ended December 31, 2018 and consisted of purchases ofproperty and equipment. Net cash used in investing activities from continuing operations was $1.3 million during the year ended December 31, 2017 and consisted of purchases ofproperty and equipment. Financing activities from continuing operations Net cash used in financing activities was $29.3 million during the year ended December 31, 2018 and consisted of $30.0 million to pay off the debt toMidCap, $2.1 million for a loss on extinguishment of debt, and payments of $383,000 for tax withheld on vesting of restricted share units, partially offsetby $3.2 million in proceeds from the exercise of share options. Net cash provided by financing activities was $39.4 million during the year ended December 31, 2017, which mainly reflected an offering that closed onAugust 18, 2017 and which resulted in approximately $39.3 million of net proceeds to us after deducting underwriting discounts and offering expenses. Discontinued operations Net cash provided by discontinued operations for 2018 was $170.9 million, primarily due to the gain on disposition from the sale of the U.S. LaboratoryServices Business to Quest, compared to $5.8 million for 2017. Cash flows for the years ended December 31, 2017 and 2016 Operating activities from continuing operations Net cash used in operating activities from continuing operations was $13.1 million during the year ended December 31, 2017, which included a net lossof $33.2 million, net non-cash expenses of $24.6 million and cash used in changes in operating assets and liabilities of $4.5 million. The non-cash itemsconsisted of intangible assets impairments charges of $18.3 million, share-based compensation expense of $5.7 million, depreciation and amortizationexpense of $1.6 million, a decrease in deferred tax assets of $1.6 million, accretion and amortization of loan fees expense of $569,000, and a $298,000loss on disposal of property and equipment. Partially offsetting these charges was a credit for the change in fair value of contingent purchase priceconsideration of $3.5 million. The cash used in operating assets and liabilities included a decrease in accounts payable and accrued liabilities of $5.0million, an increase in inventory of $1.8 million and an increase in accounts receivable of $988,000 million, partially offset by an increase in otherliabilities of $3.7 million. The decrease in accounts payable and accrued liabilities reflects the timing of certain payments. Inventory increased due totiming. The increase in accounts receivable reflects growing sales. The increase in other liabilities is mainly due to the long-term portion of the settlementwith SSI. Net cash used in operating activities from continuing operations was $27.3 million during the year ended December 31, 2016, which included a net lossof $21.6 million and cash used for changes in operating assets less liabilities of $12.1 million, partially offset by net non-cash items of $6.4 million. Thecash used for changes in operating assets and liabilities included a decrease in accounts payable and accrued liabilities of $4.3 million, an increase inprepaid expenses and other assets of $3.1 million, an increase in accounts receivable, net of $1.6 million, a decrease in deferred income of $1.6 million,and an increase in inventory, net of $1.5 million. The decrease in accounts payable and accrued liabilities was largely due to the timing of payments. Theincrease in prepaid expenses and other assets largely reflects the timing of certain payments. The increase in accounts receivable, net reflects growingrevenue during the year ended December 31, 2016 due to higher sales volumes, as well as the Imugen and Immunetics acquisitions. The decrease indeferred income primarily related to a change in the process used to determine pricing for certain sales to customers in Japan that has resulted in thosesales being recorded upon shipment. The increase in inventory, net was largely due to timing. The non-cash items consisted of share-based compensationexpense of $5.0 million, an intangible assets impairment charge of $1.8 million mainly related to IPR&D acquired from Boulder, depreciation andamortization expense of $932,000, and a $1.2 million credit from the change in fair value of contingent purchase price consideration. 50Table of Contents Investing activities from continuing operations Net cash used in investing activities from continuing operations was $1.3 million and $28.4 million for the years ended December 31, 2017 and 2016,respectively. The cash used in 2017 consisted of purchases of property and equipment. The cash used in 2016 consisted of a net $27.5 million used tofinance the acquisitions of Imugen and Immunetics and $856,000 used for purchases of property and equipment. Financing activities from continuing operations Net cash provided by financing activities from continuing operations was $39.4 million during the year ended December 31, 2017, which mainlyreflected an offering that closed on August 18, 2017 and which resulted in approximately $39.3 million of net proceeds to us after deducting underwritingdiscounts and offering expenses. The offering closed on August 18, 2017. Net cash provided by financing activities from continuing operations was $29.1 million during the year ended December 31, 2016, which mainlyreflected a $30 million MidCap borrowing, net of related discount and debt issuance costs. Discontinued operations Net cash provided by discontinued operations for 2017 was $5.8 million, compared to $3.9 million for 2016. Operating and capital expenditure requirements We have not achieved operating profitability on a quarterly or annual basis since our inception and we expect to incur net losses in the future. We expectthat our operating expenses will increase as we continue to invest to grow our customer base, expand our marketing and distribution channels, hireadditional employees and increase product development expenditures. Additionally, as a public company, we incur significant audit, legal and otherexpenses. We believe that our existing capital resources will be sufficient to fund our operations for the next few years. Our future capital requirements will depend on many factors, including: ●our ability to continue to penetrate our existing markets and new markets in the United States; ●the costs and timing of further expansion of our sales and marketing efforts; ●our ability to penetrate existing markets outside the United States and enter and develop new geographies; ●the progress that we make in developing new products based on our technology platform; ●the percentage of sales that are reimbursed by payors and our ability to collect our accounts receivable; ●our ability to generate cash from operations; and ●the acquisition of businesses or technologies that we may undertake. Contractual obligations We have contractual obligations for non-cancelable facilities leases, equipment leases, license commitments and purchase commitments. Purchasecommitments include future minimum royalty, license, and exclusivity payments to be paid under our license agreements with third parties for access tocertain technologies. The following table reflects a summary of our contractual obligations as of December 31, 2018. Payments due by period (in thousands) Total Less than1 year 1-3Years 3-5Years More than5 years Operating lease obligations $14,112 $2,024 $2,820 $1,710 $7,558 License commitments 1,268 262 193 118 695 Purchase commitments 8,723 8,723 — — — Total $24,103 $11,009 $3,013 $1,828 $8,253 Our U.K. corporate headquarters and manufacturing facility are located in Abingdon, England. We presently lease 8,600 square feet of manufacturing,storage and mixed use space pursuant to a lease that extends through December 31, 2020, or possibly sooner. Our rent for this space is currently $24,500per month. We also rent separate warehouse/storage space in Abingdon, England near our corporate headquarters. The lease on the warehouse/storagespace expires in 2025, and our current rent is $67,000 annually, which is subject to change. In June 2018, the Company entered into a lease for a new space in Abingdon, England, which extends through June 30, 2033, or the 143 Park Lease. The143 Park Lease covers 27,000 square feet of laboratory, office, storage and other mixed use space and will allow us to combine our current manufacturing,laboratory, storage and office operations into a single facility. Initial rent under the 143 Park Lease is approximately $39,000 per month. When the leaseson the Company’s existing facilities have expired and it fully occupies the space subject to the 143 Park Lease, rent will increase to $79,000 per month.Rent will be reviewed for possible increases on June 1, 2021 and every third anniversary after that date. Our U.S. corporate headquarters is located in Marlborough, Massachusetts. In August 2015, we entered into a lease amendment on this location to extendthe term of the lease by two years through October 31, 2020. In addition, beginning in March 2016, the lease amendment expanded our office space at thislocation by 7,600 square feet to a new total of 22,100 square feet. The base rent for the combined space over the lease term will range from an initial lowof $36,000 per month, which includes $12,000 per month for the expansion space commencing in early 2016, to a high of $39,000 per month. We willhave an option to extend the lease for one additional term of five years. We also currently sublease approximately 9,000 square feet of warehousing andoffice space from Quest in Norwood, Massachusetts. The base rent for this space is approximately $17,000 per month. The sublease expires in November2020. 51Table of Contents In connection with the sale of the U.S. Laboratory Services Business to Quest Diagnostics Incorporated on November 6, 2018, approximately $32.3million of the gross proceeds received pursuant to the Transaction, was paid directly to MidCap to repay the outstanding indebtedness under the MidCapagreement, which included prepayment and exit fees of approximately $2.3 million. In connection with the Company’s repayment of the outstandingindebtedness under the MidCap Agreements, the Term Loan and the Revolving Loan, and all related agreements thereunder, were terminated and allborrowings outstanding thereunder were repaid in full. Critical accounting policies and significant judgments and estimates We have prepared our consolidated financial statements in accordance with U.S. GAAP. Our preparation of these consolidated financial statementsrequires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures at thedate of the consolidated financial statements, as well as revenue and expenses during the reporting periods. We evaluate our estimates and judgments onan ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, theresults of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.Actual results could therefore differ materially from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in Note 1. Description of business and significant accounting policies, to ourconsolidated financial statements included in this Annual Report on Form 10-K, we believe the following accounting policies to be critical to thejudgments and estimates used in the preparation of our financial statements. Revenue recognition and accounts receivable The Company’s revenues include product and service revenues. Product revenue from diagnostic test kit sales and related accessories is recognized at apoint in time based upon contractual rates. Service revenue from tests performed on samples sent by direct billing customers is recorded based uponcontractually established billing rates and recognized upon delivery of test results to the customer. Revenue from tests paid by third-party payors in theU.S. includes variable consideration, which is estimated using the expected value method based on the Company’s historical collection experience. As of December 31, 2018, accounts receivables related to products and services were $9.2 million. For the year ended December 31, 2018, the Companyhad no material bad-debt expense and there were no material contract assets, contract liabilities or deferred contract costs recorded on the ConsolidatedBalance Sheet as of December 31, 2018. The Company generally expenses sales commissions when incurred because the amortization period would beless than one year. Revenue expected to be recognized in any future year related to remaining performance obligations is not material. Income taxes We account for income taxes under the asset and liability method, which requires, among other things, that deferred income taxes be provided fortemporary differences between the tax basis of our assets and liabilities and their financial statement reported amounts. In addition, deferred tax assets arerecorded for the future benefit of utilizing net operating losses, or NOLs, and research and development credit carryforwards. A valuation allowance isestablished when necessary to reduce deferred tax assets to the amount expected to be realized. We follow the accounting guidance for uncertainties in income taxes, which prescribes a recognition threshold and measurement process for recordinguncertain tax positions taken, or expected to be taken, in tax returns. Additionally, the guidance also prescribes the derecognition, classification,accounting in interim periods and disclosure requirements for uncertain tax positions. We accrue for the estimated amount of taxes for uncertain taxpositions if it is more likely than not that we would be required to pay such additional taxes. An uncertain tax position will not be recognized if it has lessthan a 50% likelihood of being sustained. We did not have any accrued interest or penalties associated with any unrecognized tax positions, and therewere no such interest or penalties recognized during the years ended December 31, 2018, 2017 or 2016. On December 22, 2017, the Tax Cuts and Jobs Act of 2017, or the TCJA, was enacted. This tax reform legislation made significant changes in U.S. tax lawincluding a reduction in the corporate tax rates, changes to net operating loss carryforwards and carrybacks, and a repeal of the corporate alternativeminimum tax. The legislation reduced the U.S. corporate tax rate from the current rate of 34% to 21% effective on January 1, 2018. As a result of theenacted law, the Company was required to revalue deferred tax assets and liabilities at the 21% rate. This resulted in a decrease in the company’s netdeferred tax asset and corresponding valuation allowance of $19.8 million. As the Company maintains a full valuation allowance against its net deferredtax asset position in the United States, this revaluation did not result in an income tax expense or benefit in 2017. The other provisions of the TCJA didnot have a material impact on the Company’s consolidated financial statements. 52Table of Contents Share-based compensation Share-based compensation relates to grants of options to purchase ordinary shares, restricted shares and restricted share units. Currently, we maintain twoequity compensation plans, the Amended and Restated 2008 Stock Incentive Plan and the 2013 Share Incentive Plan. With the adoption of the 2013Share Incentive Plan, we are no longer authorized to grant awards under the Amended and Restated 2008 Stock Incentive Plan. We measure the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date on which they aregranted. Estimating fair value for options requires determining the most appropriate valuation model, which is dependent on the terms and conditions ofthe grant. This estimate also requires determining the most appropriate inputs to the valuation model, including the expected life of the award, volatilityand dividend yield, and making certain assumptions about the award. Share-based compensation expense for restricted shares is calculated based on thegrant date market price of the shares and is recognized over the vesting period. We use the Black-Scholes option pricing model to value the share option awards. The Black-Scholes option pricing model requires the input of subjectiveassumptions, including assumptions about the expected life of share-based payment awards and share price volatility. In addition, when we were a privatecompany, one of the most subjective inputs into the Black-Scholes option pricing model was the estimated fair value of our ordinary shares. Due to thelack of an adequate history of a public market for the trading of our ordinary shares and a lack of adequate company specific historical and impliedvolatility data, we have based our estimate of expected volatility in part on our volatility, as well as on the historical volatility of a group of similarcompanies that are publicly traded. For these analyses, we have selected companies with comparable characteristics to ours including enterprise value,risk profiles, position within the industry, and with historical share price information sufficient to meet the expected life of the share-based awards. Wecompute the historical volatility data using the daily closing prices for the selected companies' shares during the equivalent period of the calculatedexpected term of our share-based awards. We will continue to apply this process until a sufficient amount of historical information regarding the volatilityof our own share price becomes available. We determine the expected term for share option grants to employees based on the “simplified” method prescribed under Staff Accounting BulletinTopic 14: Share-based Payments. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and thecontractual term of the option. The risk-free interest rate is a weighted-average assumption equivalent to the expected term based on the United StatesTreasury yield curve in effect as of the date of grant. The assumptions used in calculating the fair value of the share-based payment awards represent ourbest estimate and involve inherent uncertainties and the application of our judgment. As a result, if factors change and we use different assumptions,share-based compensation expense could be materially different in the future. In accordance with Financial Accounting Standards Board, Accounting Standards Codification 718, Compensation—Stock Compensation, we recognizeexpense based on the share option grant’s pre-defined vesting schedule over the requisite service period using the straight-line method for all employeeshare options. In addition to the assumptions used to calculate the fair value of the share options, we elected to estimate the expected forfeiture rate of allshare-based awards and only recognize expense for those awards expected to vest. The estimation of the number of share awards that will ultimately vestrequires judgment, and to the extent actual results or updated estimates differ from our current estimates, such amounts will be recorded as a cumulativeadjustment in the period in which estimates are revised. We consider multiple factors when estimating expected forfeitures, including employee positionand historical employee turnover data. During the period in which the share options vest, we will record additional expense if the actual forfeiture rate islower than the estimated forfeiture rate and a recovery of expense if the actual forfeiture rate is higher than estimated. Business combinations For acquisitions meeting the definition of a business combination, we allocate the purchase price, including any contingent consideration, to the assetsacquired and the liabilities assumed at their estimated fair values as of the date of the acquisition with any excess of the purchase price paid over theestimated fair value of net assets acquired recorded as goodwill. The fair value of the assets acquired and liabilities assumed is typically determined byusing either estimates of replacement costs or discounted cash flow valuation methods. When determining the fair value of tangible assets acquired, we estimate the cost using the most appropriate valuation method with assistance fromindependent third-party specialists. When determining the fair value of intangible assets acquired, we use judgment to estimate the applicable discountrate, growth rates and the timing and amount of future cash flows. The fair value of assets acquired and liabilities assumed is typically determined bymanagement using the assistance of independent third-party specialists. The assumptions used in calculating the fair value of tangible and intangibleassets represent our best estimates. If factors change and we were to use different assumptions, valuations of tangible and intangible assets and theresulting goodwill balance related to the business combination could be materially different. 53Table of Contents Goodwill Goodwill is not amortized but is reviewed for impairment at least annually in the fourth quarter of the year, or when events or changes in the businessenvironment indicate that all, or a portion, of the carrying value of the reporting unit may no longer be recoverable, using the two-step impairment review.Under this method, we compare the fair value of the goodwill to its carrying value. If the fair value is less than the carrying amount, a more detailedanalysis is performed to determine if goodwill is impaired. An impairment loss, if any, is measured as the excess of the carrying value of goodwill over thefair value of goodwill. We also have the option to first assess qualitative factors to determine whether the existence of events or circumstances leads us todetermine that it is more likely than not (that is, a likelihood of more than 50%) that goodwill is impaired. If we choose to first assess qualitative factorsand it is determined that it is not more likely than not goodwill is impaired, we are not required to take further action to test for impairment. We also havethe option to bypass the qualitative assessment and perform only the quantitative impairment test, which we may choose to do in some periods but not inothers. Off-balance sheet arrangements We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or specialpurpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or for any other contractually narrow orlimited purpose. Recent accounting pronouncements See Note 1. Description of business and significant accounting policies, to our consolidated financial statements included in this Annual Report on Form10-K for a discussion of the impact of recent accounting pronouncements on our consolidated financial statements. 54Table of Contents Item 7A. Quantitative and Qualitative Disclosures About Market Risk As of December 31, 2018, we had cash and cash equivalents of $192.8 million. We are exposed to market risks in the ordinary course of our business. These market risks are principally limited to interest rate fluctuations, capitalmarket fluctuations and foreign currency exchange rate fluctuations, as discussed below. Interest rate fluctuations Changes in the general level of U.S. and European interest rates expose us to interest rate risk. These changes could affect our interest income. Based onour cash and cash equivalents at December 31, 2018, if interest rates went either up or down one percentage point, this could change our interest incomeby approximately $1.8 million per annum. Capital market fluctuations Our cash and cash equivalents are invested in interest-bearing savings and money market accounts. We do not enter into investments for trading orspeculative purposes. We do not believe capital market fluctuations would have a material effect on the fair market value of our portfolio. Foreign currency exchange rate fluctuations We are exposed to foreign exchange rate risk because we currently operate in three major regions of the world: the United States, Europe and ROW andAsia, and our revenue is denominated in multiple currencies. Approximately 28% of our sales during the year ended December 31, 2018 were in theUnited States, which are denominated in U.S. Dollars. Sales in China and South Korea are also denominated in U.S. Dollars but these sales are made by ourUnited Kingdom-based subsidiary where the Pound Sterling is the functional currency. As a result, these sales are subject to remeasurement into PoundsSterling and then translation into U.S. Dollars when we consolidate our financial statements. Sales in Europe are denominated primarily in thePound Sterling and Euro. As we grow Europe and ROW sales outside the United Kingdom and the Euro Zone, we may be subject to risk from additionalcurrencies. Sales in Japan are denominated in Yen. Our expenses are generally denominated in the currencies in which our operations are located, which are primarily in the United States, the UnitedKingdom, Japan, Europe, China and South Korea. As we continue to grow our business outside the United States, our results of operations and cash flows will be subject to fluctuations due to changes inforeign currency exchange rates, which could harm our business in the future. To date, we have not entered into any foreign currency hedging contracts,although we may do so in the future. Item 8. Financial Statements and Supplementary Data The information required by this item may be found beginning on page F-1 of this Annual Report on Form 10-K with the exception of the unauditedconsolidated quarterly operations data, which is presented below. Net income (loss) per ordinary share amounts are calculated independently for each ofthe periods presented. Therefore, the sum of the quarterly net income (loss) per ordinary share amounts will not necessarily equal the total for the full fiscalyear. We have prepared the consolidated quarterly operations data on a consistent basis with the audited consolidated financial statements included elsewherein this Annual Report on Form 10-K. In the opinion of management, the quarterly consolidated operations data reflects all necessary adjustments,consisting only of normal recurring adjustments, necessary for a fair presentation of these data. Historical results are not necessarily indicative of theresults to be expected in future periods, and the results for a quarterly period are not necessarily indicative of the operating results for a full year. Thisinformation should be read in conjunction with the consolidated financial statements included elsewhere in this Annual Report Form 10-K. 55Table of Contents On November 6, 2018, Quest Diagnostics Incorporated completed its acquisition of the Company’s U.S. Laboratory Services Business. This agreementrepresents a strategic business shift having a major effect on the Company’s operations and financial results. Accordingly, the operations of this businesshave been reported in discontinued operations in the consolidated financial statements for all periods presented. Therefore, results of discontinuedoperations have been broken-out in the quarterly data presented below. Three months ended (in thousands, except share and per share data) (unaudited) March 31,2018 June 30,2018 September 30,2018 December 31,2018 Revenue: Product $10,129 $15,012 $15,095 $14,451 Service 1,550 1,645 955 916 Total revenue $11,679 $16,657 $16,050 $15,367 Gross profit $7,920 $12,119 $11,477 $11,411 (Loss) income from continuing operations $(8,186) $(5,733) $(6,258) $32,682 (Loss) income from discontinued operations (2,140) (738) 2,774 108,378 Net (loss) income (1) $(10,326) $(6,471) $(3,484) $141,060 Net (loss) income per ordinary share—basic: (Loss) income from continuing operations $(0.32) $(0.22) $(0.24) $1.24 (Loss) income from discontinued operations $(0.08) $(0.03) $0.11 $4.12 Net (loss) income $(0.40) $(0.25) $(0.13) $5.36 Net (loss) income per ordinary share—diluted: (Loss) income from continuing operations $(0.32) $(0.22) $(0.24) $1.22 (Loss) income from discontinued operations $(0.08) $(0.03) $0.11 $4.06 Net (loss) income $(0.40) $(0.25) $(0.13) $5.28 Weighted-average shares used to compute net (loss) income per ordinary share—basic 25,718,910 25,845,124 26,033,550 26,326,419 Weighted-average shares used to compute net (loss) income per ordinary share—diluted 25,718,910 25,845,124 26,033,550 26,697,589 Three months ended (in thousands, except share and per share data) (unaudited) March 31,2017 June 30,2017 September 30,2017 December 31,2017 Revenue: Product $10,770 $13,523 $13,419 $11,187 Service 1,395 1,434 1,592 1,413 Total revenue $12,165 $14,957 $15,011 $12,600 Gross profit $7,840 $9,687 $9,764 $8,972 (Loss) income from continuing operations $(6,525) $(15,590) $(19,497) $8,386 (Loss) income from discontinued operations (1,547) (1,176) 2,650 414 Net (loss) income (2) $(8,072) $(16,766) $(16,847) $8,800 Net (loss) income per ordinary share—basic: (Loss) income from continuing operations $(0.29) $(0.68) $(0.81) $0.33 (Loss) income from discontinued operations $(0.07) $(0.05) $0.11 $0.02 Net (loss) income (3) $(0.36) $(0.74) $(0.70) $0.34 Net (loss) income per ordinary share—diluted: (Loss) income from continuing operations $(0.29) $(0.68) $(0.81) $0.31 (Loss) income from discontinued operations $(0.07) $(0.05) $0.11 $0.02 Net (loss) income (3) $(0.36) $(0.74) $(0.70) $0.33 Weighted-average shares used to compute net (loss) income per ordinary share: Basic 22,533,531 22,805,379 24,123,574 25,532,152 Diluted 22,533,531 22,805,379 24,123,574 26,828,912 (1)The three months ended December 31, 2018 included a $146.0 million gain on the sale of our U.S. Laboratory Services Business to Quest pursuant to a Limited LiabilityCompany Interest Purchase Agreement from which we received approximately $130.2 million in cash proceeds. Upon closing of the Transaction, approximately $32.3million was paid directly to MidCap in settlement of all amounts due, which included prepayment and exit fees of approximately $2.3 million. (2)The three months ended June 30, 2017 included a $9.6 million Release and Settlement Agreement, or the Settlement Agreement, with Statens Serum Institut, or SSI, toresolve outstanding disputes arising from our previous license agreement. The terms of the Settlement Agreement are confidential. Based on the Settlement Agreement,we no longer expect to pay royalties to SSI, which will improve future margins. The three months ended September 30, 2017 included an impairment charge of $11.1million to write-off certain intangibles acquired in conjunction with the 2016 acquisition of Imugen, including $9.2 million related to IPR&D, $1.1 million related tocustomer relationships and $701,000 related to the Imugen trade name. The three months ended December 31, 2017 included a $27.5 million one-time, lump-sumpayment for the settlement of a lawsuit. See Part I, Item 3. Legal Proceedings for further information. Additionally, the three months ended December 31, 2017 includedan impairment charge of $7.2 million to write-off certain intangibles acquired in conjunction with the 2016 acquisition of Immunetics. (3)Net (loss) income per ordinary share amounts may not equal the sums of the respective columns due to rounding. Our revenue fluctuates from quarter-to-quarter as a result of a number of factors, many of which are outside our control. Additionally, we see fluctuation inour product revenue from quarter to quarter, due to ordering patterns, particularly relating to our large distributor customers. As a result of such factors, weexpect to continue to see quarter-to-quarter variations in our revenue. 56Table of Contents Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure There have been no changes in or disagreements with accountants on accounting and financial disclosure matters in the last fiscal year. Item 9A. Controls and procedures (a) Evaluation of disclosure controls and procedures Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosurecontrols and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Form 10-K. Based on suchevaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective due to amaterial weakness in our internal controls relating to income tax accounting that existed as of December 31, 2018, as discussed below. (b) Management’s report on internal control over financial reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in SecuritiesExchange Act Rule 13a-15(f). Management, including our Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of our internalcontrol over financial reporting as of December 31, 2018. In making this assessment, management used the framework in Internal Control—IntegratedFramework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management hasconcluded that we did not maintain effective internal control over financial reporting as of December 31, 2018 because of the material weaknessidentified below. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is areasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timelybasis. We did not design and maintain effective internal control over the accounting for income taxes, including the income tax provision, deferred tax assetsand liabilities and related disclosures. Specifically, we did not have sufficient technical expertise in the income tax function to review with a level ofprecision that would have identified a material misstatement in the income tax provision, including the allocation of tax between continuing anddiscontinued operations as well as the calculation of deferred tax assets and liabilities and related disclosures. Management and the Audit Committeebelieve that the complexity introduced to the Company's financial statements as a result of the sale of the Company's U.S. laboratory service business toQuest, or the Transaction, was a contributing factor to the identified deficiencies. Oxford Immunotec Global PLC’s independent registered public accounting firm, Ernst & Young LLP, has audited the Company’s internal control overfinancial reporting as of December 31, 2018, as stated in their report, which appears herein. (c) Remediation of Material Weakness Under the oversight of our Audit Committee, we are committed to improving our internal controls processes and resolving the material weakness we havepresented above. As we continue to evaluate and work to improve our internal control over financial reporting, we may implement additional measures ormodify the remedial actions described below, as considered appropriate, to remediate our material weakness. Management’s preliminary assessment of a remediation plan to address the control deficiencies that led to the material weakness includes the following: i.enhancing corporate tax accounting resources to strengthen tax accounting review procedures; ii.reassessing the design of our tax review controls to identify areas where enhanced precision will help detect and prevent material misstatements;and iii.assessing the involvement of a third party provider. Management will report regularly to the Audit Committee regarding the status of the implementation of the remediation activities. Our goal is toremediate this material weakness by the end of 2019, subject to there being sufficient opportunities to conclude, through testing, that the enhancedcontrols are operating effectively. (d) Changes in internal control over financial reporting On November 6, 2018, we completed the sale of our U.S. Laboratory Services Business to Quest. As a result of the Transaction, certain U.S. servicebusiness controls were eliminated in the fourth quarter of 2018. The Company also added new controls relating to the divestiture process. In conjunctionwith the Transaction, a newly formed wholly owned subsidiary of Oxford Immunotec Limited, Oxford Immunotec USA, Inc., was incorporated into ourexisting internal control processes. Other than with respect to our sale of the U.S. Laboratory Services Business to Quest as described above and the material weakness discussed herein, therehave been no changes to our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during thefourth quarter of 2018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other information None. 57Table of Contents PART III Item 10. Directors, Executive Officers and Corporate Governance The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, to be filedwith the Commission not later than 120 days after the close of our fiscal year ended December 31, 2018. Item 11. Executive Compensation The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, to be filedwith the Commission not later than 120 days after the close of our fiscal year ended December 31, 2018. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, to be filedwith the Commission not later than 120 days after the close of our fiscal year ended December 31, 2018. Item 13. Certain Relationships and Related Transactions and Director Independence The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, to be filedwith the Commission not later than 120 days after the close of our fiscal year ended December 31, 2018. Item 14. Principal Accounting Fees and Services The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, to be filedwith the Commission not later than 120 days after the close of our fiscal year ended December 31, 2018. 58Table of Contents PART IV Item 15. Exhibits, Financial Statement Schedules (a)1. Financial Statements As part of this Annual Report on Form 10-K, the consolidated financial statements are listed in the accompanying index to financial statements on page F-1. 2. Financial Statement Schedules All schedules have been omitted because they are not required, not applicable, not present in amounts sufficient to require submission of the schedule, orthe required information is otherwise included. 3. Exhibit Index The following is a list of exhibits filed as part of this Annual Report on Form 10-K: ExhibitnumberDescription of exhibit 2.1*+Purchase Agreement, dated June 23, 2016, between Oxford Immunotec, Inc. and Imugen, Inc. (Filed as Exhibit 2.1 to our Current Reporton Form 8-K on July 6, 2016, and incorporated herein by reference.) 2.2+†Limited Liability Company Interest Purchase Agreement by and among Quest Diagnostics Incorporated, Oxford Immunotec Limited,Oxford Immunotec, Inc. and solely for the purposes of Section 5.4, Section 5.6, Section 5.12, Section 5.16, Article VII and Article IX,Oxford Immunotec Global PLC (Filed as Exhibit 2.1 of our Form 8-K on September 25, 2018 and incorporated herein by reference) 3.1Articles of Association of the Registrant (Filed as Exhibit 3.1 of our Form 8-K on June 18, 2014 and incorporated herein by reference.) 4.1Form of Ordinary Shares Certificate (Filed as Exhibit 4.1 of Amendment No. 5 to our Registration Statement on Form S-1 (File No. 333-191737) on November 8, 2013 and incorporated herein by reference.) 10.1+Supply Agreement dated December 17, 2010 between MicroCoat Biotechnologie GmbH and Oxford Immunotec Limited (Filed as Exhibit10.11 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein by reference.) 10.2Amendment to Supply Agreement dated April 5, 2016 between MicroCoat Biotechnologie GmbH and Oxford Immunotec Limited (Filedas Exhibit 10.2 to our Quarterly Report on Form 10-K on May 4, 2016, and incorporated herein by reference.) 10.3+Purchase Agreement dated February 6, 2010 between Mabtech AB and Oxford Immunotec Limited (Filed as Exhibit 10.12 of ourRegistration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein by reference.) 10.4+Amendment to Purchase Agreement dated September 10, 2013 between Mabtech AB and Oxford Immunotec Limited (Filed as Exhibit10.13 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein by reference.) 10.5+Second Amendment to Purchase Agreement between Mabtech AB and Oxford Immunotec Limited dated November 17, 2017 (Filed asExhibit 10.5 of our Annual Report on Form 10-K on February 27, 2018 and incorporated herein by reference.) 10.6+Manufacturing Agreement dated August 26, 2003 between Mabtech AB and Oxford Immunotec Limited (Filed as Exhibit 10.14 of ourRegistration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein by reference.) 10.7First Amendment dated January 1, 2010 to Manufacturing Agreement between Mabtech AB and Oxford Immunotec Limited (Filed asExhibit 10.15 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein byreference.) 10.8Second Amendment dated May 24, 2011 to Manufacturing Agreement between Mabtech AB and Oxford Immunotec Limited (Filed asExhibit 10.16 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein byreference.) 10.9+Supply Agreement dated January 31, 2008 between StemCell Technologies, Inc. and Oxford Immunotec Limited (Filed as Exhibit 10.19of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein by reference.) 59Table of Contents ExhibitnumberDescription of exhibit10.10+Amendment dated October 26, 2011 to Supply Agreement between StemCell Technologies, Inc. and Oxford Immunotec Limited (Filed asExhibit 10.20 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein byreference.) 10.11+Second Amendment to Supply Agreement dated September 1, 2017 between StemCell Technologies Canada Inc. f/k/a StemCellTechnologies, Inc. and Oxford Immunotec Limited (Filed as Exhibit 10.1 of our Form 10-Q on October 31, 2017 and incorporated hereinby reference.) 10.12+Supplier Agreement dated January 7, 2019 between Millipore (UK) Ltd. and Oxford Immunotec Limited. 10.13+Amended and Restated Supply and Reseller Agreement dated January 9, 2019 between Life Technologies Corporation and OxfordImmunotec Limited 10.14+Distributorship Agreement dated October 8, 2013 among Shanghai Fosun Long March Medical Science Co. Ltd., Shanghai Xin ChangMedical Device Co. Ltd. and Oxford Immunotec Limited (Filed as Exhibit 10.24 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein by reference.) 10.15+First Amendment to Distributorship Agreement between Oxford Immunotec, Ltd., Fosun Long March Medical Science Co. Ltd. andShanghai Xin Chang Medical Device Co. Ltd. dated April 22, 2015 (Filed as Exhibit 10.1 of our Quarterly Report on Form 10-Q onAugust 4, 2015 and incorporated herein by reference.) 10.16+Second Amendment to Distributorship Agreement between Oxford Immunotec, Ltd., Fosun Long March Medical Science Co. Ltd. andShanghai Xin Chang Medical Device Co. Ltd. dated November 3, 2016. (Filed as Exhibit 10.20 of our Annual Report on Form 10-K onMarch 1, 2017 and incorporated herein by reference.) 10.17+Third Amendment to Distributorship Agreement between Oxford Immunotec, Ltd., Fosun Long March Medical Science Co. Ltd. andShanghai Xin Chang Medical Device Co. Ltd. entered into on December 20, 2017(Filed as Exhibit 10.21 of our Annual Report on Form10-K on February 27, 2018 and incorporated herein by reference.) 10.18+Fourth Amendment to Distributorship Agreement between Oxford Immunotec, Ltd., Fosun Long March Medical Science Co. Ltd. andShanghai Xin Chang Medical Device Co. Ltd. dated June 5, 2018 (Filed as Exhibit 10.1 of our Quarterly Report on Form 10-Q on July 31,2018 and incorporated herein by reference.) 10.19+Fifth Amendment to Distributorship Agreement between Oxford Immunotec, Ltd., Fosun Long March Medical Science Co. Ltd. andShanghai Xin Chang Medical Device Co. Ltd. dated September 17, 2018 (Filed as Exhibit 10.1 of our Quarterly Report on Form 10-Q onNovember 9, 2018 and incorporated herein by reference.) 10.20+Marketing Authorization Holder Agreement dated July 29, 2011 between Riken Genesis Co., Ltd. and Oxford Immunotec Limited (Filedas Exhibit 10.25 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein byreference.) 10.21+Amendment to Marketing Authorization Holder Agreement dated September 1, 2013 between Riken Genesis Co., Ltd. and OxfordImmunotec Limited (Filed as Exhibit 10.26 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 andincorporated herein by reference.) 10.22Amendment to Marketing Authorization Holder Agreement dated April 1, 2016 between Riken Genesis Co., Ltd. and Oxford ImmunotecLimited (Filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q on May 4, 2016, and incorporated herein by reference.) 10.23Amendment to Marketing Authorization Holder Agreement dated July 7, 2017 between Riken Genesis Co., Ltd. and Oxford ImmunotecLimited (Filed as Exhibit 10.1 of our Form 8-K on July 28, 2017 and incorporated herein by reference.) 10.24Amended and Restated 2008 Stock Incentive Plan (Filed as Exhibit 10.35 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein by reference.) 10.25Oxford Immunotec Global PLC 2013 Share Incentive Plan (Filed as Exhibit 10.39 of Amendment No. 6 of our Registration Statement onForm S-1 (File No. 333-191737) on November 14, 2013 and incorporated herein by reference.) 10.26Oxford Immunotec Global PLC 2013 Amended Share Incentive Plan (Filed as Exhibit 10.33 of our Annual Report on Form 10-K onFebruary 27, 2018 and incorporated herein by reference.) 10.27Form of Director Stock Option Award under Oxford Immunotec Global PLC 2013 Share Incentive Plan (Filed as Exhibit 10.48 ofAmendment No. 5 to our Registration Statement on Form S-1 (File No. 333-191737) on November 8, 2013 and incorporated herein byreference.) 60Table of Contents ExhibitnumberDescription of exhibit10.28Form of Restricted Share Award Certificate under the Oxford Immunotec Global PLC 2013 Share Incentive Plan for officers resident in theUnited States (Filed as Exhibit 10.2 of our Form 8-K on March 6, 2014 and incorporated herein by reference.) 10.29Form of Restricted Share Award Certificate under the Oxford Immunotec Global PLC 2013 Share Incentive Plan for officers resident in theUnited Kingdom (Filed as Exhibit 10.1 of our Form 8-K on March 6, 2014 and incorporated herein by reference.) 10.30Form of First Amendment to Officer Restricted Share Award (Double Trigger) under Appendix C of the 2013 Share Incentive Plan (Filed asExhibit 10.1 of our Form 8-K on January 2, 2015 and incorporated herein by reference.) 10.31Form of First Amendment to Officer Stock Option Award under Appendix D of the 2013 Share Incentive Plan (Filed as Exhibit 10.2 of ourForm 8-K on January 2, 2015 and incorporated herein by reference.) 10.32Form of CSOP Option Certificate (Annual Vesting) under the Oxford Immunotec Global PLC 2013 Share Incentive Plan for officersresident in the United Kingdom (Filed as Exhibit 10.39 of our Annual Report on Form 10-K on March 1, 2016 and incorporated herein byreference). 10.33Form of Unapproved Stock Option Award (Annual Vesting) under the Oxford Immunotec Global PLC 2013 Share Incentive Plan forofficers resident in the United Kingdom (Filed as Exhibit 10.41 of our Form 10-K on March 1, 2016 and incorporated herein by reference). 10.34Form of Stock Option Agreement (Annual Vesting) under the Oxford Immunotec Global PLC 2013 Share Incentive Plan for officersresident in the United States (Filed as Exhibit 10.43 of our Annual Report on Form 10-K on March 1, 2016 and incorporated herein byreference). 10.35Form of Unapproved Stock Option Award (Double Trigger) under the Oxford Immunotec Global PLC 2013 Share Incentive Plan (Filed asExhibit 10.44 of our Annual Report on Form 10-K on February 27, 2018 and incorporated herein by reference.) 10.36Form of Restricted Share Unit Award under the Oxford Immunotec Global PLC 2013 Share Incentive Plan for officers (Filed as Exhibit10.44 of our Annual Report on Form 10-K on March 1, 2016 and incorporated herein by reference). 10.37Service Agreement dated October 21, 2002 between Oxford Immunotec Limited and Peter Wrighton-Smith, as amended through 2013(Filed as Exhibit 10.45 of our Annual Report on Form 10-K on March 27, 2014 and incorporated herein by reference.) 10.38Deed of Novation of Agreement for Services dated November 8, 2013 by and among Oxford Immunotec Limited, Oxford ImmunotecGlobal PLC and Peter Wrighton-Smith (Filed as Exhibit 10.49 of Amendment No. 5 to our Registration Statement on Form S-1 (File No.333-191737) on November 8, 2013 and incorporated herein by reference.) 10.39Amended and Restated Employment Agreement dated October 1, 2013 between Oxford Immunotec, Inc. and Richard M. Altieri (Filed asExhibit 10.43 of our Registration Statement on Form S-1 (File No. 333-191737) on October 15, 2013 and incorporated herein byreference.) 10.40Form of Employment Agreement for Senior Executives (Filed as Exhibit 10.50 of our Annual Report on Form 10-K on February 27, 2018and incorporated herein by reference.) 10.41Form of Deed of Indemnity for Directors (Filed as Exhibit 10.44 of Amendment No. 5 to our Registration Statement on Form S-1 (File No.333-191737) on November 8, 2013 and incorporated herein by reference.) 10.42Form of Deed of Indemnity for Officers (Filed as Exhibit 10.45 of Amendment No. 5 to our Registration Statement on Form S-1 (File No.333-191737) on November 8, 2013 and incorporated herein by reference.) 10.43Form of Non-Executive Director Appointment Letter (Filed as Exhibit 10.46 of Amendment No. 2 to our Registration Statement on FormS-1 (File No. 333-191737) on November 4, 2013 and incorporated herein by reference.) 10.44Agreement to Purchase Test Kits and Accessories dated November 6, 2018 between Quest Diagnostics Incorporated and OxfordImmunotec USA, Inc. (Filed as Exhibit B to the IPA filed as Exhibit 2.1 of our Form 8-K on September 25, 2018 and incorporated hereinby reference) 10.45Form of Bonus Agreement (Filed as Exhibit 10.2 of our Quarterly Report on Form 10-Q on November 9, 2018 and incorporated herein byreference) 10.46Form of Bonus Agreement (Filed as Exhibit 10.3 of our Quarterly Report on Form 10-Q on November 9, 2018 and incorporated herein byreference) 10.47Separation Agreement dated March 8, 2019 between Richard A. Wenstrup and Oxford Immunotec USA, Inc. 61Table of Contents ExhibitnumberDescription of exhibit21.1List of Subsidiaries 23.1Consent of Ernst & Young LLP (US) 23.2Consent of Ernst & Young LLP (UK) 24.1Power of Attorney executed by Directors and Officers (included on signature page) 31.1Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101The following materials from the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, formatted in XBRL(eXtensible Business Reporting Language): (i) Consolidated balance sheets as of December 31, 2018 and 2017; (ii) Consolidatedstatements of operations for the years ended December 31, 2018, 2017 and 2016; (iii) Consolidated statements of other comprehensiveincome (loss) for the years ended December 31, 2018, 2017 and 2016; (iv) Consolidated statements of shareholders’ equity for the yearsended December 31, 2018, 2017 and 2016; (v) Consolidated statements of cash flows for the years ended December 31, 2018, 2017 and2016; and (vi) Notes to consolidated financial statements.* All schedules (and similar attachments) to the Purchase Agreement were omitted pursuant to Section 601(b)(2) of Regulation S-K. The Registranthereby agrees to furnish supplementally a copy of any omitted schedule (or other attachment) to the SEC. + Confidential treatment has been granted or requested with respect to certain portions of this exhibit. Omitted portions have been submitted separately tothe SEC. † Certain exhibits and schedules to the Purchase Agreement have been omitted pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omittedschedule and exhibit will be furnished supplementally to the Securities and Exchange Commission upon request. Item 16. Form 10-K Summary None. 62Table of Contents Signatures Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on itsbehalf by the undersigned, thereunto duly authorized, in Abingdon, England, on March 27, 2019. OXFORD IMMUNOTEC GLOBAL PLC By:/s/ Peter Wrighton-Smith, Ph.D. Peter Wrighton-Smith, Ph.D.Chief Executive Officer and Director Power of Attorney KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Peter Wrighton-Smith, Ph.D.,Richard M. Altieri, and Elizabeth M. Keiley, and each of them, as his or her true and lawful attorneys-in-fact and agents, with full power of substitutionand resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Reporton Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission,granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite andnecessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirmingthat all said attorneys-in-fact and agents, or any of them or their or his or her substitute or substitutes, may lawfully do or cause to be done by virtuehereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of theregistrant on March 27, 2019 in the capacities indicated below. Signature TitleDate /s/ Peter Wrighton-Smith, Ph.D. Chief Executive Officer and DirectorMarch 27, 2019Peter Wrighton-Smith, Ph.D. (Principal Executive Officer) /s/ Richard M. Altieri Chief Financial OfficerMarch 27, 2019Richard M. Altieri (Principal Financial and Accounting Officer) /s/ Richard A. Sandberg Chairman of the Board of DirectorsMarch 27, 2019Richard A. Sandberg /s/ Ronald Andrews Jr. DirectorMarch 27, 2019Ronald Andrews Jr. /s/ Patrick J. Balthrop, Sr. DirectorMarch 27, 2019Patrick J. Balthrop, Sr. /s/ Mark Klausner DirectorMarch 27, 2019Mark Klausner /s/ Patricia Randall DirectorMarch 27, 2019Patricia Randall /s/ Herm Rosenman DirectorMarch 27, 2019Herm Rosenman /s/ James R. Tobin DirectorMarch 27, 2019James R. Tobin /s/ A. Scott Walton DirectorMarch 27, 2019A. Scott Walton /s/ Richard M. Altieri Authorized Representative in the United StatesMarch 27, 2019Richard M. Altieri 63Table of Contents Oxford Immunotec Global PLC Index to financial statements Audited consolidated financial statements Page Report of independent registered public accounting firmF-2 Consolidated balance sheets as of December 31, 2018 and 2017F-5 Consolidated statements of operations for the years ended December 31, 2018, 2017 and 2016F-6 Consolidated statements of other comprehensive income (loss) for the years ended December 31, 2018, 2017 and 2016F-7 Consolidated statements of shareholders’ equity for the years ended December 31, 2018, 2017 and 2016F-8 Consolidated statements of cash flows for the years ended December 31, 2018, 2017 and 2016F-9 Notes to the consolidated financial statementsF-11 F-1Table of Contents Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Oxford Immunotec Global Plc Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Oxford Immunotec Global Plc (the Company) as of December 31, 2018, the relatedconsolidated statements of income, comprehensive income, shareholders' equity and cash flows for the year ended December 31, 2018, and the relatednotes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in allmaterial respects, the financial position of the Company at December 31, 2018, and the results of its operations and its cash flows for the year endedDecember 31, 2018, in conformity with U.S. generally accepted accounting principles. We also have 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 issued by theCommittee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated March 27, 2019 expressed an adverseopinion thereon. Basis for Opinion These 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 audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to theCompany in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and thePCAOB. 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 the financial statements are free of material misstatement, whether due to error or fraud. Our audit 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 audit 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 audit provides a reasonable basis for our opinion. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2018. Boston, MassachusettsMarch 27, 2019 F-2Table of Contents Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Oxford Immunotec Global Plc Opinion on Internal Control over Financial Reporting We have audited Oxford Immunotec Global Plc’s internal control over financial reporting as of December 31, 2018, based on criteria established inInternal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), (theCOSO criteria). In our opinion, because of the effect of the material weakness described below on the achievement of the objectives of the control criteria,Oxford Immunotec Global Plc (the Company) has not maintained effective internal control over financial reporting as of December 31, 2018, based on theCOSO criteria. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibilitythat a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. The followingmaterial weakness has been identified and included in management’s assessment. Management has identified a deficiency in controls related to theaccounting for income taxes, including the income tax provision and related tax assets and liabilities, and has concluded that such deficiency representeda material weakness as of December 31, 2018. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the accompanyingconsolidated balance sheets of the Company as of December 31, 2018, the related consolidated statements of income, comprehensive income,shareholders' equity and cash flows for the year ended December 31, 2018, and the related notes. This material weakness was considered in determiningthe nature, timing, and extent of audit tests applied in our audit of the 2018 consolidated financial statements, and this report does not affect our reportdated March 27, 2019 which expressed an unqualified opinion thereon. Basis for Opinion The 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 an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing andevaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considerednecessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. Definition and Limitations of Internal Control Over Financial Reporting A 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 internalcontrol over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accuratelyand fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded asnecessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures ofthe company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assuranceregarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on thefinancial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluationof effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree ofcompliance with the policies or procedures may deteriorate. /s/ Ernst & Young LLPBoston, MassachusettsMarch 27, 2019 F-3Table of Contents Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Oxford Immunotec Global PLC Opinion on the Financial Statements We have audited the accompanying consolidated balance sheet of Oxford Immunotec Global PLC (the Company) as of December 31, 2017, the relatedconsolidated statements of operations, other comprehensive loss, shareholders’ equity and cash flows for each of the two years in the period endedDecember 31, 2017, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financialstatements present fairly, in all material respects, the financial position of the Company at December 31, 2017, and the results of its operations and its cashflows for each of the two years in the period ended December 31, 2017, in conformity with U.S. generally accepted accounting principles. Basis for Opinion These 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 Public Company Accounting Oversight Board (United States)(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules andregulations 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. The Company is not required to have, norwere we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding ofinternal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control overfinancial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, andperforming procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosuresin the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well asevaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ Ernst & Young LLP We served as the Company’s auditor from 2006 to 2018. Reading, United Kingdom February 27, 2018, except for the effects of discontinued operations described in Notes 1 and 19, as to which the date is March 27, 2019 F-4Table of Contents Oxford Immunotec Global PLCConsolidated balance sheets(in thousands, except share and per share data) December 31, 2018 2017 Assets Current assets: Cash and cash equivalents $192,844 $90,332 Accounts receivable, net 9,158 6,021 Other receivable 4,500 — Inventory, net 7,767 7,137 Prepaid expenses and other assets 2,511 2,711 Current assets of discontinued operations — 14,281 Total current assets 216,780 120,482 Restricted cash, non-current 100 200 Other receivable 4,500 — Property and equipment, net 7,144 2,764 Goodwill 2,483 2,483 Other intangible assets, net 61 1,036 Deferred tax asset 1,052 2,486 Noncurrent assets of discontinued operations — 14,785 Total assets $232,120 $144,236 Liabilities and shareholders’ equity Current liabilities: Accounts payable $2,801 $5,552 Accrued liabilities 10,891 7,807 Settlement liability 4,106 4,342 Deferred income 125 36 Current portion of loans payable 85 78 Current liabilities of discontinued operations — 4,630 Total current liabilities 18,008 22,445 Long-term portion of loans payable 106 29,856 Settlement liability — 3,894 Other liabilities — 364 Noncurrent liabilities of discontinued operations — 48 Total liabilities 18,114 56,607 Commitments and contingencies (Notes 3, 9, and 16) Shareholders’ equity: Ordinary shares, £0.006705 nominal value; 38,978,604 and 36,183,293 shares authorized at December 31,2018 and 2017, respectively, 26,439,334 and 25,661,634 shares issued and outstanding at December 31,2018 and 2017, respectively 276 269 Additional paid-in capital 303,015 294,613 Accumulated deficit (80,762) (201,541)Accumulated other comprehensive loss (8,523) (5,712)Total shareholders’ equity 214,006 87,629 Total liabilities and shareholders’ equity $232,120 $144,236 See accompanying notes to these consolidated financial statements. F-5Table of Contents Oxford Immunotec Global PLCConsolidated statements of operations(in thousands, except share and per share data) Year ended December 31, 2018 2017 2016 Revenue: Product $54,687 $48,899 $43,070 Service 5,066 5,834 3,918 Total revenue 59,753 54,733 46,988 Cost of revenue: Product 13,668 13,864 13,807 Service 3,158 4,606 2,684 Total cost of revenue 16,826 18,470 16,491 Gross profit 42,927 36,263 30,497 Operating expenses: Research and development 8,122 10,835 9,370 Sales and marketing 26,500 29,053 26,858 General and administrative 25,952 25,450 18,918 Change in fair value of contingent purchase price consideration — (3,475) (1,208)Intangible assets impairment charge 879 18,300 1,765 Settlement expense 2,193 10,028 — Total operating expenses 63,646 90,191 55,703 Operating loss from continuing operations (20,719) (53,928) (25,206)Other income (expense): Interest expense, net (1,797) (3,105) (864)Loss on extinguishment of debt (2,105) — — Foreign exchange gains (losses) 111 (1,850) 1,364 Other expense (271) (209) (646)Litigation settlement income — 27,500 — Loss from continuing operations before income taxes (24,781) (31,592) (25,352)Income tax benefit (expense) from continuing operations 37,286 (1,634) 3,774 Income (loss) from continuing operations 12,505 (33,226) (21,578)Discontinued operations: Income (loss) from discontinued operations before income taxes 1,727 341 (771)Gain on disposition 145,982 — — Income tax expense (39,435) — — Income (loss) from discontinued operations 108,274 341 (771)Net income (loss) $120,779 $(32,885) $(22,349) Net income (loss) per ordinary share—basic: Income (loss) from continuing operations $0.48 $(1.40) $(0.97)Income (loss) from discontinued operations 4.17 0.01 (0.03)Net income (loss) $4.65 $(1.38) $(1.00) Net income (loss) per ordinary share—diluted: Income (loss) from continuing operations $0.47 $(1.40) $(0.97)Income (loss) from discontinued operations 4.10 0.01 (0.03)Net income (loss) $4.58 $(1.38) $(1.00) Weighted-average shares used to compute net income (loss) per ordinary share—basic 25,982,809 23,757,902 22,353,713 Weighted-average shares used to compute net income (loss) per ordinary share—diluted 26,397,875 23,757,902 22,353,713 See accompanying notes to these consolidated financial statements. F-6Table of Contents Oxford Immunotec Global PLCConsolidated statements of other comprehensive income (loss)(in thousands) Year ended December 31, 2018 2017 2016 Net income (loss) $120,779 $(32,885) $(22,349)Other comprehensive gain (loss), net of taxes: Foreign currency translation adjustment, net of tax charges / (credits) of $791,$(1,178), and $0, respectively (2,811) 2,039 (2,474)Other comprehensive gain (loss), net of taxes (2,811) 2,039 (2,474)Total comprehensive income (loss) $117,968 $(30,846) $(24,823) See accompanying notes to these consolidated financial statements. F-7Table of Contents Oxford Immunotec Global PLCConsolidated statements of shareholders’ equity(in thousands) Ordinaryshares Additionalpaid-incapital Accumulateddeficit Accumulatedothercomprehensivegain (loss) Totalshareholders’equity Balance at December 31, 2015 243 244,033 (146,307) (5,277) 92,692 Exercise of share options — 76 — — 76 Share-based compensation expense — 5,019 — — 5,019 Other comprehensive loss — — — (2,474) (2,474)Net loss — — (22,349) — (22,349)Balance at December 31, 2016 243 249,128 (168,656) (7,751) 72,964 Exercise of share options 4 557 — — 561 Issuance of shares in secondary offering 22 39,276 — — 39,298 Share-based compensation expense — 5,864 — — 5,864 Tax on vesting of restricted share units — (212) — — (212)Other comprehensive gain — — — 2,039 2,039 Net loss — — (32,885) — (32,885)Balance at December 31, 2017 269 294,613 (201,541) (5,712) 87,629 Exercise of share options 7 3,234 — — 3,241 Share-based compensation expense — 5,551 — — 5,551 Tax on vesting of restricted share units — (383) — — (383)Other comprehensive loss — — — (2,811) (2,811)Net income — — 120,779 — 120,779 Balance at December 31, 2018 $276 $303,015 $(80,762) $(8,523) $214,006 See accompanying notes to these consolidated financial statements. F-8Table of Contents Oxford Immunotec Global PLCConsolidated statements of cash flows(in thousands) Year ended December 31, 2018 2017 2016 Cash flows from operating activities Net income (loss) $120,779 $(32,885) $(22,349)Less: Net income (loss) from discontinued operations, net of tax 108,274 341 (771)Net income (loss) from continuing operations 12,505 (33,226) (21,578) Adjustments to reconcile net income (loss) from continuing operations to net cash used inoperating activities: Depreciation and amortization of intangible assets 1,662 1,618 932 Change in fair value of contingent purchase price consideration — (3,475) (1,208)Intangible assets impairment charges 879 18,300 1,765 Accretion and amortization of loan fees 2,408 569 — Share-based compensation expense 4,507 5,671 4,901 Loss (income) on disposal of property and equipment 115 298 — Deferred income taxes (38,760) 1,602 — Changes in operating assets and liabilities: Accounts receivable, net (3,390) (988) (1,642)Inventory, net (1,015) (1,768) (1,486)Prepaid expenses and other assets 207 (454) (3,063)Accounts payable (10,375) (5,502) (7,326)Accrued liabilities 3,252 509 3,069 Other liabilities, net (4,209) 3,733 (36)Deferred income 95 (9) (1,639)Net cash used in operating activities from continuing operations (32,119) (13,122) (27,311) Cash flows from investing activities Purchases of property and equipment (5,350) (1,295) (856)Cash paid for acquisitions, net of cash acquired — — (27,515)Net cash used in investing activities from continuing operations (5,350) (1,295) (28,371) Cash flows from financing activities Proceeds from issuance of ordinary shares — 39,298 — Proceeds from exercise of share options 3,241 561 76 Payments of tax withheld on vesting of restricted share units (383) (212) — Payments on capital lease (60) (261) (80)Proceeds from term loan, net — — 29,457 Discount on the line of credit — — (50)Debt issuance costs — — (289)Loss on extinguishment of debt (2,105) — — Change in loans payable (30,000) — — Net cash (used in) provided by financing activities from continuing operations (29,307) 39,386 29,114 Net cash flows of continuing operations (66,776) 24,969 (26,568)Cash flows from discontinued operations Net operating cash flows provided by discontinued operations 14,729 9,548 5,401 Net investing cash flows provided by (used in) discontinued operations 156,218 (3,734) (1,527)Net financing cash flows used in discontinued operations (48) (12) (11)Net cash flows of discontinued operations 170,899 5,802 3,863 Effect of exchange rate changes on cash and cash equivalents, including restricted cash (1,711) 451 (1,780)Net increase (decrease) in cash and cash equivalents, including restricted cash 102,412 31,222 (24,485)Cash, cash equivalents, and restricted cash at beginning of year 90,532 59,310 83,795 Cash, cash equivalents, and restricted cash at end of year $192,944 $90,532 $59,310 See accompanying notes to these consolidated financial statements. F-9Table of Contents Oxford Immunotec Global PLCConsolidated statements of cash flows (continued)(in thousands) Year ended December 31, 2018 2017 2016 Supplemental disclosures Cash paid for interest $2,656 $3,123 $450 Cash paid for taxes 76 145 141 See accompanying notes to these consolidated financial statements. F-10Table of Contents Oxford Immunotec Global PLCNotes to consolidated financial statements 1. Description of business and significant accounting policies Description of business The Company is a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for immunology and infectiousdisease by leveraging the technological, product development, manufacturing, quality, regulatory, and sales and marketing capabilities it has developedover its sixteen year history. The Company’s proprietary T-SPOT.TB test utilizes its T-SPOT technology platform to test for tuberculosis, which is theleading cause of infectious disease death worldwide. On November 6, 2018, the Company completed the sale of its U.S. Laboratory Services Business to Quest, for gross proceeds of $170 million in cash. ThisTransaction represented a strategic business shift and it had a major effect on the Company’s operations and financial results. Following the Transaction,the Company has approximately 210 employees, including sales and marketing teams on three continents, and a laboratory in the United Kingdom. Discontinued operations The Company reports the results of operations of a business that either has been disposed of or is classified as held for sale, in accordance with AccountingStandards Codification, or ASC, 360, Property, Plant, and Equipment, in discontinued operations, as required by ASC 205, Presentation of FinancialStatements. The Company presents such events as discontinued operations so long as the financial results can be clearly identified and the futureoperations and cash flows are completely eliminated from ongoing operations. The Company’s historical results for all periods presented are restated toaccount for businesses reported as discontinued operations in our Consolidated Financial Statements and these Notes. Unless otherwise specified,disclosures in our Consolidated Financial Statements and these Notes relate solely to our continuing operations. As discussed in Note 19, Discontinued operations, on September 25, 2018, the Company entered into an agreement to sell the Company’s U.S. LaboratoryServices Business to Quest Diagnostics Incorporated. The Transaction represents a strategic business shift having a major effect on the Company’soperations and financial results. Accordingly, the assets and liabilities of this and the related operations have been reported in discontinued operations inthe consolidated financial statements for all periods presented. The Transaction was consummated on November 6, 2018. Basis of presentation, accounting principles and principles of consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the UnitedStates of America, or U.S. GAAP, and include the financial statements of Oxford Immunotec Global PLC, a company incorporated in England and Walesand its wholly-owned subsidiaries, collectively referred to as the Company. All intercompany accounts and transactions have been eliminated uponconsolidation. Segment reporting The Company operates in one operating segment. The Company’s chief operating decision maker, or the CODM, its chief executive officer, manages theCompany’s operations on an integrated basis for the purposes of allocating resources. When evaluating the Company’s financial performance, the CODMreviews separate revenue information for the Company’s product and service offerings and for each country, while all other financial information is on aconsolidated basis. While the Company’s principal operations and decision-making functions are located in both the United States and United Kingdom,the CODM makes decisions on a global basis. Accordingly, the Company has determined that it operates in a single reporting segment. Use of estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affectthe reported amounts of assets and liabilities at the date of the consolidated financial statements and that affect the reported amounts of revenue andexpenditures during the reporting periods. Actual results could differ from those estimates and assumptions used. Foreign currency translation The functional currency for Oxford Immunotec Global PLC is the U.S. Dollar. The functional currency for the Company’s operating subsidiaries are thePound Sterling for Oxford Immunotec Limited, the U.S. Dollar for Oxford Immunotec USA, Inc., Oxford Immunotec Inc. and Immunetics, Inc., orImmunetics, the Yen for Oxford Immunotec K.K., the Yuan for Oxford Immunotec (Shanghai) Medical Device Co. Ltd., the Euro for Boulder DiagnosticsEurope GmbH and the Hong Kong Dollar for Oxford Immunotec Asia Limited. Revenue and expenses of foreign operations are translated into U.S. Dollarsat the average rates of exchange during the year. Assets and liabilities of foreign operations are translated into U.S. Dollars at year-end rates. The Companyreflects resulting foreign currency translation adjustments in accumulated other comprehensive income, which is a component of shareholders’ equity. Realized and unrealized foreign currency transaction gains or losses, arising from exchange rate fluctuations on balances denominated in currencies otherthan the functional currencies, are included in “Other income (expense)” in the consolidated statements of operations unless the unrealized foreigncurrency transaction gains or losses relate to intercompany transactions of a long-term investment nature, then they are included in other comprehensiveincome. F-11Table of Contents Concentration of risks In the year ended December 31, 2018, the Company had two product customers that represented more than 10% of the Company’s annual revenue. TheCompany’s Chinese distributor, Shanghai Fosun Long March Medical Science Co. Ltd., or Fosun, represented approximately 27% of annual revenue andthe Company’s Japanese importer, Riken Genesis Co., Ltd. represented approximately 19% of annual revenue. The loss of either of these productcustomers could have a material impact on the Company’s operating results. Cash and cash equivalents and restricted cash The Company considers all highly liquid investments purchased with maturities at acquisition of three months or less to be cash equivalents. TheCompany maintains its available cash balances in cash, money market funds and repurchase agreements primarily invested in U.S. government andagency securities, and bank savings accounts in the United States, United Kingdom, Germany, Japan, China and South Korea. The Company maintainsdeposits in government insured financial institutions in excess of government insured limits. Management believes that the Company is not exposed tosignificant credit risk due to the financial position of the depository institutions in which those deposits are held. Restricted cash relates to collateral for procurement cards issued by a U.S. commercial bank. Cash, cash equivalents, and restricted cash consists of the following: Year ended December 31, (in thousands) 2018 2017 2016 Cash and cash equivalents $192,844 $90,332 $59,110 Restricted cash, non-current 100 200 200 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $192,944 $90,532 $59,310 Accounts receivable Accounts receivable are primarily amounts due from customers including hospitals, public health departments, commercial testing laboratories,distributors and universities in addition to government programs. Accounts receivable are reported net of an allowance for uncollectible accounts. The process of estimating the collection of accounts receivable involvessignificant assumptions and judgments. Specifically, the accounts receivable allowance is based on management’s analysis of current and past dueaccounts, collection experience and other relevant information. The Company’s provision for uncollectible accounts is recorded as a bad debt expenseand included in general and administrative expenses. Account balances are written-off against the allowance when it is probable that the receivable willnot be recovered. Although the Company believes amounts provided are adequate, the ultimate amounts of uncollectible accounts receivable could be inexcess of the amounts provided. Inventory Inventory consists of raw materials, work in progress and finished goods. The Company does not maintain work in progress balances as the nature of themanufacturing process does not allow for test kits to be left in a partially manufactured state. Inventory is removed at cost. Inventory is stated at the lowerof cost or net realizable value. Cost is determined by the actual cost of components by batch plus estimated labor and overhead costs per unit. Netrealizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, andtransportation. The Company reviews the components of its inventory on a periodic basis for excess, obsolete or impaired inventory, and records a reservefor identified items. Property and equipment Property and equipment are stated at cost. Property and equipment financed under capital leases are initially recorded at the present value of minimumlease payments at the inception of the lease. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. Property and equipment under capital leases andleasehold improvements are amortized using the straight-line method over the shorter of the lease term or estimated useful life of the asset. Depreciablelives range from three to ten years for laboratory equipment, office equipment and furniture and fixtures and three years for software. F-12Table of Contents Revenue recognition The Company’s revenues include product and service revenues. Product revenue from diagnostic test kit sales and related accessories is recognized at apoint in time based upon contractual rates. Service revenue is recorded based upon contractually established billing rates and recognized upon delivery oftest results to the customer. See Note 2 for disaggregation of revenue by type, indication and geography. As of December 31, 2018, accounts receivables related to products and services were $9.2 million. For the year ended December 31, 2018, the Companyhad no material bad-debt expense and there were no material contract assets, contract liabilities or deferred contract costs recorded on the ConsolidatedBalance Sheet as of December 31, 2018. The Company generally expenses sales commissions when incurred because the amortization period would beless than one year.Revenue expected to be recognized in any future year related to remaining performance obligations is not material. Taxes assessed by governmental authorities on revenue, including sales and value added taxes, are recorded on a net basis (excluded from revenue) in theconsolidated statements of operations. Cost of revenue: cost of product and cost of service Cost of product revenue consists primarily of costs incurred in the production process, including costs of raw materials and components, assembly laborand overhead, quality management, royalties paid under licensing agreements and packaging and delivery costs. Cost of service revenue consists primarily of costs incurred in the operation of the Company’s diagnostic laboratory including labor and overhead, kitcosts, quality management, consumables used in the testing process and packaging and delivery costs. Shipping and handling The Company generally bills product customers for shipping and handling and records the customer payments as product revenue. The associated costsare recorded as cost of product sold. The Company does not normally bill its service customers for shipping and handling charges. Charges relating to inbound and outbound freight costs arenormally incurred by the Company and recorded within cost of service. Impairment of long-lived assets The Company’s long-lived assets, including fixed assets and intangible assets which have a definite life, are evaluated for impairment whenever events orchanges in circumstances indicate that the carrying amount of an asset may be impaired, and assesses their recoverability based upon anticipated futurecash flows. If changes in circumstances lead the Company to believe that any of its long-lived assets may be impaired, the Company will (a) evaluate theextent to which the remaining book value of the asset (group) is recoverable by comparing the estimated undiscounted future cash flows attributable tothe asset (group) in question to its carrying amount and (b) write-down the carrying amount to fair value to the extent necessary. Business combinations For acquisitions meeting the definition of a business combination, the Company allocates the purchase price, including any contingent consideration, tothe assets acquired and the liabilities assumed at their estimated fair values as of the date of the acquisition with any excess of the purchase price paid overthe estimated fair value of net assets acquired recorded as goodwill. When determining the fair value of tangible assets acquired, the Company estimates the cost using the most appropriate valuation method with assistancefrom independent third-party specialists. When determining the fair value of intangible assets acquired, the Company uses judgment to estimate theapplicable discount rate, growth rates and the timing and amount of future cash flows. The fair value of assets acquired and liabilities assumed is typicallydetermined by management using the assistance of independent third-party specialists. The assumptions used in calculating the fair value of tangible andintangible assets represent the Company’s best estimates. If factors changed and the Company were to use different assumptions, valuations of tangibleand intangible assets and the resulting goodwill balance related to the business combination could be materially different. Goodwill and indefinite-lived intangible assets Goodwill Goodwill is not amortized but is reviewed for impairment at least annually in the fourth quarter of the year, or when events or changes in the businessenvironment indicate that all, or a portion, of the carrying value of the reporting unit may no longer be recoverable, using the two-step impairment review.Under this method, the Company compares the fair value of the goodwill to its carrying value. If the fair value is less than the carrying amount, a moredetailed analysis is performed to determine if goodwill is impaired. An impairment loss, if any, is measured as the excess of the carrying value of goodwillover the fair value of goodwill. The Company also has the option to first assess qualitative factors to determine whether the existence of events orcircumstances leads it to determine that it is more likely than not (that is, a likelihood of more than 50%) that goodwill is impaired. If the Companychooses to first assess qualitative factors and determines that the fair value of the reporting unit more likely than not exceeded its carrying value, then it isnot required to take further action to test goodwill for impairment. The Company also has the option to bypass the qualitative assessment and performonly the quantitative impairment test, which it may choose to do in some periods but not in others. F-13Table of Contents Indefinite-lived intangible assets Indefinite-lived intangible assets are reviewed for impairment at least annually, or when events or changes in the business environment indicate thecarrying value may be impaired. If the fair value of the intangible asset is less than the carrying amount, the Company performs a quantitative test todetermine the fair value. The impairment loss, if any, is measured as the excess of the carrying value of the intangible asset over its fair value. TheCompany also has the option to first assess qualitative factors to determine whether the existence of events or circumstances leads it to determine that it ismore likely than not (that is, a likelihood of more than 50%) that its indefinite-lived intangible asset is impaired. If the Company chooses to first assessqualitative factors and determines that the fair value of the indefinite-lived intangible assets more likely than not exceeded their carrying value, then it isnot required to test for impairment. The Company also has the option to bypass the qualitative assessment and perform only the quantitative impairmenttest, which it may choose to do in some periods but not in others. The determinations as to whether, and, if so, the extent to which, indefinite-lived intangible assets become impaired are highly judgmental and based onsignificant assumptions regarding the projected future financial condition and operating results, changes in the manner of the use and development of theacquired assets, the Company’s overall business strategy, and regulatory, market and economic environment and trends. Definite-lived intangible assets Intangible assets include technology licenses which are capitalized and amortized over estimated useful lives (generally in the range of five to twentyyears) using the straight-line method. Derivative financial instruments The Company does not use derivative instruments to hedge exposures to cash flow, market, interest rate or foreign currency risks. The Company reviews the terms of the shares it issues to determine whether there are embedded derivative instruments, including embedded conversionoptions, which are required to be bifurcated and accounted for separately as derivative financial instruments. In circumstances where the host instrumentcontains more than one embedded derivative instrument, including the conversion option, that is required to be bifurcated, the bifurcated derivativeinstruments are accounted for as a single, compound derivative instrument. Bifurcated embedded derivatives are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value reported asother income or expense. When equity instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, thetotal proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated tothe host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. Fair value of financial instruments The Company measures certain financial assets and liabilities at fair value based on the price that would be received for an asset or paid to transfer aliability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants. As of December 31,2018 and 2017, the Company’s financial instruments consist of cash and cash equivalents, accounts receivable, prepaid expenses, and other accountspayable, accrued liabilities, and loans payable. See Note 3. Fair value measurement, to the consolidated financial statements for further information onthe fair value of the Company’s financial instruments. Research and development expenses Research and development expenses include all costs associated with the development of the Company’s technology platforms and potential futureproducts including new diagnostic tests that utilize the Company’s technology platforms and are charged to expense as incurred. Research anddevelopment expenses include direct costs and an allocation of indirect costs, including amortization, depreciation, rent, supplies, insurance and repairsand maintenance. F-14Table of Contents Share-based compensation The Company accounts for share-based compensation arrangements with employees, officers and directors by recognizing compensation expense basedon the grant date fair value of share-based transactions in the consolidated financial statements. Share-based compensation for options is based on the fair value of the underlying option calculated using the Black-Scholes option-pricing model on thedate of grant for share options and recognized as expense on a straight-line basis over the requisite service period. Determining the appropriate fair valuemodel and related assumptions requires judgment, including estimating share price volatility, expected term and forfeiture rates. The expected volatilityrates are estimated based on the Company’s actual volatility and the actual volatility of comparable public companies over a historical period equal inlength to the expected term. The expected terms represent the average time that options are expected to be outstanding based on the midpoint between thevesting date and the end of the contractual term of the award. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periodsif actual forfeitures differ from those estimates. The Company has not paid dividends and does not anticipate paying cash dividends in the foreseeablefuture and, accordingly, uses an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturitiesconsistent with the estimated expected term of the awards. Certain employees have been granted restricted share units, or RSUs, and restricted shares. The fair value of RSUs and restricted shares are calculatedbased on the closing sale price of the Company’s ordinary shares on the date of grant. The cumulative expense recognized for share-based transactions at each reporting date until the vesting date reflects the extent to which the vestingperiod has expired and the Company’s best estimate of the number of equity instruments that will ultimately vest. The charge or credit for a periodrepresents the movement in cumulative expense recognized as of the beginning and end of that period. No expense is recognized for awards that do notultimately vest. Where the terms of an equity award are modified, the minimum expense recognized is the expense as if the terms had not been modified if the originalterms of the award are met. An additional expense is recognized for any modification that increases the total fair value of the share-based compensation, oris otherwise beneficial to the employee as measured at the date of modification. Where a share-based compensation award is cancelled, it is treated as if it had vested on the date of cancellation, and any expense not yet recognized forthe award is recognized immediately. However, if a new award is substituted for the cancelled award, and designated as a replacement award on the date itis granted, the cancelled and new awards are treated as if they were a modification of the original award, as described in the previous paragraph. Upon exercise, share options are redeemed for newly issued ordinary shares. Income taxes The Company accounts for income taxes under the asset and liability method, which requires, among other things, that deferred income taxes be providedfor temporary differences between the tax basis of the Company’s assets and liabilities and its financial statement reported amounts. In addition, deferredtax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. A valuation allowance isestablished when necessary to reduce deferred tax assets to the amount expected to be realized. The Company adheres to the accounting guidance for uncertainties in income taxes, which prescribes a recognition threshold and measurement processfor recording in the financial statements uncertain tax positions taken, or expected to be taken, in a tax return. The Company accrues for the estimatedamount of taxes for uncertain tax positions if it is more likely than not that the Company would be required to pay such additional taxes. An uncertain taxposition will not be recognized if it has less than a 50% likelihood of being sustained. Interest and penalties are recognized as a component of income taxexpense. Basic and diluted net income (loss) per ordinary share Basic income (loss) per ordinary share are calculated by dividing the net income (loss) by the weighted-average number of ordinary shares outstandingduring the period. Diluted income per ordinary share is calculated by dividing net income by the weighted-average number of ordinary shares outstandingduring the period plus the dilutive effect of outstanding instruments such as share options, RSUs and restricted shares. Diluted loss per ordinary share isthe same as basic loss per ordinary share, as the effect of utilizing the fully diluted share count including share options, RSUs and restricted shares wouldreduce the net loss per ordinary share. Recently Adopted Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts withCustomers, or ASU 2014-09, which converges the FASB and the International Accounting Standards Board standards on revenue recognition. Under ASU2014-09, a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects theconsideration to which the company expects to be entitled in exchange for those goods or services. In addition, ASU 2014-09 requires certain additionaldisclosures around the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. The FASB has issuedseveral amendments to the standard, including clarification on accounting for licenses of intellectual property, identifying performance obligations andother technical corrections. The Company adopted ASU 2014-09 on January 1, 2018, using the modified retrospective approach. The adoption of ASU2014-09 did not have a material impact on the Company’s financial position, results of operations, equity or cash flows as of the adoption date or for theyear ended December 31, 2018. The Company has included the disclosures required by ASU 2014-09 above and in Note 2. Revenue to the ConsolidatedFinancial Statements. F-15Table of Contents In August 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments, or ASU 2016-15. ASU 2016-15 is intendedto reduce the diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. TheCompany adopted ASU 2016-15 retrospectively as of January 1, 2018. The adoption of ASU 2016-15 has not had a material impact on the Company’sstatement of cash flows. In October 2016, the FASB issued ASU 2016-16, Income Taxes, or ASU 2016-16. The guidance requires companies to recognize the income tax effects ofintercompany sales and transfers of assets, other than inventory, in the income statement as income tax expense (or benefit) in the period in which thetransfer occurs. The Company adopted ASU 2016-16 retrospectively as of January 1, 2018. The adoption of ASU 2016-16 has not had a material impacton the Company’s financial position, results of operations or related disclosures. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, or ASU 2016-18. ASU 2016-18 requires that astatement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash orrestricted cash equivalents. The Company adopted ASU 2016-18 retrospectively as of January 1, 2018. The adoption of ASU 2016-18 has not had amaterial impact on the Company’s statement of cash flows. In January 2017, the FASB issued ASU 2017-01, Business Combinations, or ASU 2017-01. ASU 2017-01 clarifies the definition of a business with theobjective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets orbusinesses. The Company adopted ASU 2017-01 prospectively as of January 1, 2018. The adoption of ASU 2017-01 has not had a material impact on theCompany’s financial position, results of operations or related disclosures. In May 2017, the FASB issued ASU 2017-09, Scope of Modification Accounting, or ASU 2017-09. ASU 2017-09 provides guidance about which changesto the terms or conditions of a share-based payment award require an entity to apply modification accounting of a share-based payment award. Theguidance should be applied prospectively to an award modified on or after the adoption date. The Company adopted ASU 2017-09 prospectively as ofJanuary 1, 2018. The adoption of ASU 2017-09 has not had a material impact on the Company’s financial position, results of operations or relateddisclosures. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases, or ASU 2016-02. ASU 2016-02 requires lessees to reflect all leases with terms longer than 12months on their balance sheets. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition inthe income statement. The FASB has subsequently issued amendments to the guidance, including the addition of an optional transition method. TheCompany’s process of evaluating the impact of ASU 2016-02 has included reviewing all forms of leases and performing a completeness assessment overthe lease population. The Company will adopt ASU 2016-02, effective as of January 1, 2019 and will apply the alternative adoption approach at theadoption date and will recognize a cumulative-effect adjustment, if any, to the opening balance of retained earnings. The Company will take advantage ofthe transition package of practical expedients permitted within ASU 2016-02, which among other things, will allow it to carryforward historical leaseclassifications. The Company will make an accounting policy election that will keep leases with an initial term of 12 months or less and that do notinclude an option to purchase the underlying asset that the Company is reasonably certain to exercise off of the balance sheet and will result inrecognizing those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. As a result of adopting ASU2016-02, the Company expects to recognize right-of-use assets of about $7.7 million and corresponding liabilities of about $8.6 million for its existinglease portfolio on its consolidated balance sheets, with no material impact to the Company’s consolidated statements of operations or consolidatedstatements of cash flows. For the first quarter of 2019, the Company will provide additional disclosures in the notes to its condensed consolidatedfinancial statements regarding its leasing portfolio, including key judgments and assumptions and the discount rates used in calculating the Company’sright-of-use assets and corresponding liabilities. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses, or ASU 2016-13. ASU 2016-13 requires a financial asset (or a group offinancial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. Under current U.S. GAAP, a company onlyconsidered past events and current conditions in measuring an incurred loss. Under ASU 2016-13, the information that a company must consider isbroadened in developing an expected credit loss estimate for assets measured either collectively or individually. The use of forecasted informationincorporates more timely information in the estimate of expected credit loss. The new guidance will be effective for the Company for annual and interimperiods beginning after December 15, 2019. Early adoption is permitted for annual and interim periods beginning after December 15, 2018. The guidanceis applied using a modified retrospective, or prospective approach, depending on a specific amendment. The Company does not expect that theapplication of ASU 2016-13 will have a material impact on the presentation of its results of operations, financial position or disclosures. In January 2017, the FASB issued ASU 2017-04, Intangibles – Goodwill and Other, or ASU 2017-04. ASU 2017-04 simplifies subsequent measurement ofgoodwill by eliminating Step 2 from the goodwill impairment test. The new guidance will be applied on a prospective basis. ASU 2017-04 will beeffective for the Company for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption ispermitted for interim or annual goodwill impairment tests. The Company is currently evaluating ASU 2017-04. In June 2018, the FASB issued ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, or ASU 2018-07. ASU 2018-07 simplifiesthe accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certainexceptions. ASU 2018-07 will be effective for the Company for fiscal years beginning after December 15, 2018, including interim periods within thatfiscal year. Early adoption is permitted. The Company is currently evaluating ASU 2018-07. F-16Table of Contents 2. Revenue On January 1, 2018, we adopted FASB ASC Topic 606, Revenue from Contracts with Customers, or ASC Topic 606, under the modified retrospectiveapproach using the practical expedient in paragraph 606-10-10-4. The five step model defined by ASC Topic 606 requires us to (1) identify our contractswith customers, (2) identify our performance obligations under those contracts, (3) determine the transaction prices of those contracts, (4) allocate thetransaction prices to our performance obligations in those contracts and (5) recognize revenue when each performance obligation under those contracts issatisfied. Revenue is recognized when promised goods or services are transferred to the customer in an amount that reflects the consideration expected inexchange for those goods or services. Our adoption of ASC Topic 606 did not result in an adjustment to our accumulated deficit and did not have amaterial impact on the amount and timing of our revenue recognition for the year ended December 31, 2018. The Company’s prior year revenues have been recast to present the U.S. Laboratory Services Business as a discontinued operation. For further informationon these changes, refer to Note 19. Discontinued operations. The following tables present the Company’s revenues disaggregated by type: Year ended December 31, (in thousands) 2018 2017 2016 Revenue Product $54,687 $48,899 $43,070 Service 5,066 5,834 3,918 Total revenue $59,753 $54,733 $46,988 The following tables reflect revenue by geography (United States, Europe and rest of world, or Europe and ROW, and Asia): Year ended December 31, (in thousands, except percentages) 2018 2017 2016 Revenue United States $16,442 28% $15,720 29% $10,372 22%Europe and ROW 9,153 15% 8,136 15% 6,988 15%Asia 34,158 57% 30,877 56% 29,628 63%Total revenue $59,753 100% $54,733 100% $46,988 100% 3. Fair value measurement As a basis for determining the fair value of certain of the Company’s financial instruments, the Company utilizes a three-tier value hierarchy, whichprioritizes the inputs used in measuring fair value as follows: Level 1—Observable inputs such as quoted prices in active markets for identical assets or liabilities. Level 2—Observable inputs, other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not activeor other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determiningfair value. The carrying amount of certain of the Company’s financial instruments, including cash, accounts receivable, prepaid expenses and other assets,accounts payable, and accrued liabilities approximate fair value due to their short term nature. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair valuemeasurement. The Company’s assessment of the significance of a particular input to the entire fair value measurement requires management to makejudgments and consider factors specific to the asset or liability. The Company had a term loan outstanding under an agreement with MidCap Financial Trust, or MidCap, at December 31, 2017. The amount outstandingon the term loan was reported at its carrying value in the accompanying balance sheet at that date. The estimated fair value of the term loan, based uponmarket rates at the time for similar borrowings, as measured using Level 2 inputs, approximated the carrying amount as presented on the consolidatedbalance sheets. In connection with the sale of the U.S. Laboratory Services Business to Quest on November 6, 2018, approximately $32.3 million of thegross proceeds received pursuant to the Transaction, was paid directly to MidCap to repay the outstanding indebtedness under the MidCap agreement,which included prepayment and exit fees of approximately $2.3 million (see Note 9. Loans payable). F-17Table of Contents 4. Accounts receivable, net Accounts receivable, net, consisted of the following as of: December 31, (in thousands) 2018 2017 Accounts receivable $9,246 $6,021 Less allowance for uncollectible accounts receivable (88) — Accounts receivable, net $9,158 $6,021 Activity for the allowance for uncollectible accounts receivable is as follows: December 31, (in thousands) 2018 2017 2016 Balance at beginning of period $— $— $— Provision for bad debt expense (88) — — Write-off — — — Balance at end of period $(88) $— $— 5. Inventory, net Inventory consisted of the following as of: December 31, (in thousands) 2018 2017 Raw materials $6,169 $6,927 Work in progress 190 179 Finished goods 1,408 31 Inventory $7,767 $7,137 6. Property and equipment, net Property and equipment, net consists of the following as of: December 31, (in thousands) 2018 2017 Laboratory equipment $2,951 $2,493 Leasehold improvements 5,663 2,766 Office equipment, furniture and fixtures 3,019 2,205 Software 1,626 756 Construction in progress — 94 Property and equipment 13,259 8,314 Less accumulated depreciation (6,115) (5,550)Property and equipment, net $7,144 $2,764 For the years ended December 31, 2018, 2017 and 2016, the Company recorded depreciation expense of $1.6 million, $1.4 million and $0.9 million,respectively. Depreciation expense includes amortization of capital leases. Depreciable lives range from three to ten years for laboratory equipment, office equipment, leasehold improvements, and furniture and fixtures and threeyears for software and specialized shipping containers. For the years ended December 31, 2018 and 2017, there were no material capital leases, disposals or retirements. F-18Table of Contents 7. Goodwill and intangible assets The Company has one reporting unit and goodwill represents the synergies realized in its acquisitions of Imugen, Inc., or Imugen, and Immunetics, Inc., orImmunetics. In conjunction with the Transaction (see Note 19. Discontinued operations) and pursuant to ASC 350-20-35-51, the Company allocated aportion of the goodwill to the business being disposed of based on the relative fair value method. As a result, goodwill of $1.5 million was allocated toassets held for sale in the third quarter of 2018, the period that the held for sale election was determined. The carrying amount of goodwill reflected in theCompany’s consolidated balance sheets was $2.5 million at December 31, 2018 and 2017. Acquired intangible assets consisted of the following as of December 31, 2018 and 2017 (in thousands): As of December 31, 2018 Amortizationperiod (years) Grosscarryingamount AccumulatedAmortization Netcarryingamount Licenses 5-10 $652 $591 $61 Total $652 $591 $61 As of December 31, 2017 Amortizationperiod (years) Grosscarryingamount AccumulatedAmortization Netcarryingamount Immunetics technology – clinical 15 $883 $72 $811 Immunetics customer relationships 5-11 130 14 116 Immunetics trade name 5 30 8 22 Other 5-10 692 605 87 Total $1,735 $699 $1,036 In conjunction with the Transaction, the net carrying amount of definite-lived intangible assets recorded in the acquisition of Imugen were disposed ofand netted into the gain on sale. The weighted average amortization period of our definite-lived intangible assets is 9.7 years. Amortization expense from continuing operations for theyears ended December 31, 2018, 2017 and 2016 was $93,000, $206,000 and $71,000, respectively. Amortization expense related to acquired intangibleassets is estimated at $22,000 per year for the years 2019 and 2020 and $17,000 in 2021. The acquisition of Immunetics was accounted for under the acquisition method of accounting and the purchase price allocation was provisionallyprepared during the fourth quarter of 2016. In the second quarter of 2017, the Company finalized the accounting for the acquisition and recorded thefollowing measurement period adjustments: ●the fair value of the acquired inventory decreased by $45,000 with corresponding increases to the clinical technology asset of $22,500 and togoodwill of $22,500 ●the fair value of the acquired customer relationships decreased by $50,000 with a corresponding increase to goodwill ●the fair value of the Immunetics trade name decreased by $130,000 with a corresponding increase to goodwill ●a $58,000 decrease to goodwill due to changes in income tax expense F-19Table of Contents The impact on the consolidated statement of operations as of December 31, 2017 was a $44,000 reduction in cost of product revenue, a $26,000 reductionin sales and marketing expense and a $58,000 increase in income tax expense. During the fourth quarter of 2016, the Company recorded a non-cash IPR&D impairment charge of $1.4 million related to an assay for Lyme disease thatwas acquired in conjunction with the Boulder acquisition when it was determined that the Boulder IPR&D will not directly yield any products. In the third quarter of 2017, due to increased competition in the molecular blood donor screening market for Babesia microti, the Company recorded animpairment charge of $11.1 million to write-off certain intangible assets acquired in conjunction with the 2016 acquisition of Imugen including: ●$9.2 million related to Imugen IPR&D; ●$1.1 million related to customer relationships; and ●$701,000 related to the Imugen trade name. In mid-February 2018, the Company received a complete response letter, or CRL, from FDA which raised a number of questions related to the Company’ssubmissions in the fourth quarter of 2017 in support of licensure for the Immunetics Babesia microti blood donor screening assay. Given FDA’s previousverbal comments to the Company, the CRL was unexpected and would have delayed licensure and commercialization of the assay. As a result, theCompany recorded an impairment charge of $7.2 million to write off the intangible assets related to the assay including: ●$7.0 million related to Immunetics IPR&D; ●$166,000 related to the Immunetics trade name; and ●$98,000 related to customer relationships. Impairment review Immunetics definite-lived intangible assets The Company reviews the carrying value of its long-lived assets, including other intangible assets, for impairment whenever events or changes incircumstances indicate that the carrying value of an asset or asset group may not be recoverable. The Company evaluates recoverability based uponundiscounted future cash flows expected to be generated by such assets (group) over the remaining useful lives. On November 6, 2018, the Company soldits U.S. Laboratory Services Business to Quest pursuant to a Limited Liability Company Interest Purchase Agreement for approximately $170 million (SeeNote 19. Discontinued operations). Following this transaction, Management held strategic meetings that resulted in an impairment review of the assetsgroup related to Immunetics. Upon impairment review, the Company recorded an impairment charge of $879,000 to write off the Immunetics intangibleassets in the fourth quarter of 2018. Goodwill Goodwill is not amortized but is reviewed for impairment at least annually in the fourth quarter of the year, or when events or changes in the businessenvironment indicate that all, or a portion, of the carrying value of the reporting unit may no longer be recoverable, using the two-step impairment review.Based on the results of the Company’s annual review of goodwill, it has been determined that there is no impairment loss to be recorded in the fourthquarter of 2018. 8. Accrued liabilities Accrued liabilities consist of the following as of: December 31, (in thousands) 2018 2017 Employee related expenses $5,536 $4,317 Corporate tax 1,616 — Royalties 1,354 1,419 Other accrued liabilities 2,385 2,071 Total accrued liabilities $10,891 $7,807 F-20Table of Contents 9. Loans payable In June 2013, in conjunction with the lease for approximately 14,500 square feet of office space in Marlborough, Massachusetts, the Company received apayment of $582,000 from the landlord, representing approximately 80% of the cost to build-out the facility. In accordance with FASB AccountingStandards Codification 840, Leases, this reimbursement was recorded as a liability in loans payable and is being amortized over the life of the lease. AtDecember 31, 2018, $84,000 is included in the balance sheet in current portion of loans payable and $75,000 is included in long-term portion of loanspayable. At December 31, 2017, $77,000 is included in the balance sheet in current portion of loans payable and $159,000 is included in long-termportion of loans payable. On October 4, 2016, the Company entered into an agreement with MidCap Financial Trust, or the MidCap agreement, that provided it with $40 million indebt financing, comprised of both a term loan and a revolving line of credit. The MidCap agreement provided the Company with a term loan of $30million, which matured five years from closing. The term loan accrued interest at a rate of LIBOR plus 7.60% with interest only payments for the first 24months, with the ability to extend to 48 months subject to certain conditions, before the loan began to amortize. The MidCap agreement also provided theCompany with a revolving line of credit of up to $10 million, which matured five years from closing. The revolving line of credit accrued interest at a rateof LIBOR plus 4.45%. The Company was also required to pay the lenders an unused line fee equal to 0.50% per annum of the average unused portion ofthe revolving line of credit. Based on certain conditions, both the term loan and revolving line of credit could have been increased by an additional $10million for a total of $60 million. If the credit facility was terminated prior to the end of the term, the Company was to pay to the lenders a fee as compensation for the costs of beingprepared to make funds available to the Company throughout the term equal to an amount determined by multiplying the revolving line of creditcommitment amount by 3.0% in the first year, 2.0% in the second year, and 1.0% in the third year and thereafter. Upon repayment in full of the loan, theCompany was obligated to make a final payment fee equal to 6% of the aggregate loan amount. In addition, the Company was required to pay an exit feeof 6.0% of the aggregate principal amount of all term loan borrowings. The 6% exit fee was being accreted to interest expense through the maturity of theMidcap loan. In connection with the sale of the U.S. Laboratory Services Business to Quest pursuant to a Limited Liability Company Interest Purchase Agreement onNovember 6, 2018, approximately $32.3 million of the gross proceeds received pursuant to the Transaction was paid directly to MidCap to repay theoutstanding indebtedness under the MidCap agreement, which included prepayment and exit fees of approximately $2.3 million. In connection with theCompany’s repayment of the outstanding indebtedness under the MidCap Agreements, the Term Loan and the Revolving Loan, and all relatedagreements thereunder, were terminated and all borrowings outstanding thereunder were repaid in full. The repayment resulted in a loss onextinguishment of debt of $2.1 million, which represents the cash paid to settle the debt in excess of debt related balances at the time of settlement. As of December 31, 2017, the Company had a balance of the secured term loan due to MidCap of $30 million, which is recorded in the accompanyingconsolidated balance sheet at that date, net of unamortized discount and debt issuance costs. The Company never borrowed under the revolving line of credit. 10. Share capital During the twelve months ended 2018, the Company issued 694,322 ordinary shares upon the exercise of options and 83,378 ordinary shares were issuedupon the vesting of RSUs. During 2017, 500,182 ordinary shares were issued upon the exercise of options, and 26,021 ordinary shares were issued uponthe vesting of RSUs. There were 36,183,293 ordinary shares authorized, and 26,439,334 and 25,661,634 ordinary shares issued and outstanding, as ofDecember 31, 2018 and 2017, respectively. On August 14, 2017, the Company entered into an underwriting agreement, or the Underwriting Agreement, with BTIG, LLC, as sole underwriter, relatingto the issuance and sale of 2,500,000 ordinary shares, nominal value £0.006705 per share, at a price to the public of $16.05 per share, or the Offering,which resulted in approximately $39.3 million of net proceeds to the Company after deducting underwriting discounts and estimated offering expenses.The Offering closed on August 18, 2017. F-21Table of Contents 11. Share option and equity incentive plans The Company has issued share options since 2003, restricted shares since 2014 and RSUs since 2015 to incentivize employees and directors providingservices to the Company. Currently, the Company maintains two equity compensation plans, the Amended and Restated 2008 Stock Incentive Plan andthe 2013 Share Incentive Plan, or the Plans. With the adoption of the 2013 Share Incentive Plan or the 2013 Plan, the Company is no longer authorized togrant awards under the Amended and Restated 2008 Stock Incentive Plan. In November 2013, in connection with the Company’s IPO, the Company adopted the 2013 Plan, which provides for the grant of share options, restrictedshares, RSUs and other share-based awards to employees, officers, directors and consultants of the Company. The 2013 Plan authorized the Company togrant up to 2,684,563 ordinary shares with such amount automatically increasing annually on each January 1st through January 1, 2023 by 4% of thenumber of shares outstanding on the close of business of the immediately preceding December 31st, provided that the Board of Directors may limit theincrease to a smaller amount or to no increase in any given year. The 2013 Plan was amended in April 2017 to delete the provision that allows for yearlyincreases to the shares available for issuance under the Plan. At that time, the maximum number of shares available for future issuance was also capped at2,684,563, which is the original amount of shares allocated for issuance under the 2013 Plan. At December 31, 2018, there were 1,712,132 sharesavailable for future issuance under the 2013 Plan. Under both the 2008 Plan and the 2013 Plan, share options, and only under the 2013 Plan, restricted shares and RSUs, have been granted to employees,officers and directors who provide services to the Company. Options generally vest based on the grantee’s continued service with the Company during aspecified period following grant or, in rare instances, based on the achievement of performance or other conditions as determined by the Board ofDirectors, and expire after ten years. For options granted prior to 2015, the vesting percentage was generally 0% until the second anniversary of thevesting start date of the employee’s first option award under the 2008 Plan and either the second anniversary of the employee’s date of hire or the first dayof the month following the second anniversary of the employee’s date of hire under the 2013 Plan. Effective in 2015, the Company began grantingoptions that vest in equal parts over four years starting on the vesting start date. Generally, restricted shares and RSUs vest based on the grantees’continued service with the Company during a specified period following grant as follows: 40% on the second anniversary of the grant date; 30% on thethird anniversary of the grant date; and 30% on the fourth anniversary of the grant date. The fair value of the options was estimated at the grant date using the Black-Scholes option pricing model, taking into account the terms and conditionsupon which options are granted. The fair value of the options is amortized on a straight-line basis over the requisite service period of the awards. Theweighted-average grant date fair value per share relating to share options granted under the Plans during the years ended December 31, 2018, 2017 and2016 was $6.15, $6.31 and $4.53, respectively. Share-based compensation expense for restricted shares and RSUs is calculated based on the grant datemarket price of the shares and is also amortized on a straight-line basis over the requisite service period of the awards. The fair value of each option granted under the Plans has been calculated on the date of grant using the following assumptions: 2018 2017 2016 Expected dividend yield (%) — — — Expected volatility (%) 43.70 43.59 43.70 Risk-free interest rate (%) 2.70 1.98 1.53 Expected life of option (years) 6.25 6.20 6.16 Weighted-average share price ($) 13.37 14.06 10.29 Weighted-average exercise price ($) 4.67 14.06 10.29 Model used Black-ScholesModel Black-ScholesModel Black-ScholesModel Expected dividend yield: The Company has not paid and does not anticipate paying any dividends in the foreseeable future. Expected volatility: As the Company operated as a private company until November 2013, there is not sufficient historical volatility for the expected termof the options. Therefore, in the first half of the year, the Company used 75% of average share price volatility of the peer group companies and 25% of itsown average share price volatility. In the second half of the year, the Company used 50% of average share price volatility of the peer group companiesand 50% of its own average share price volatility. The Company intends to increase the weighting of its own historical share price volatility in itsvolatility factor calculation by 25% each year until a sufficient amount of historical information regarding the volatility of its own share price becomesavailable. Risk-free interest rate: The Company determined the risk-free interest rate by using a weighted-average equivalent to the expected term based on the U.S.Treasury yield curve in effect as of the date of grant. Expected life of options (in years): Expected life of options represents the period that the Company’s share option grants are expected to be outstanding.As the Company operated as a private company until November 2013, there is not sufficient historical share data to calculate the expected term of theoptions. Therefore, the Company elected to utilize the “simplified” method to value share option grants. Under this approach, the weighted-averageexpected life is presumed to be the average of the vesting term and the contractual term of the option. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from estimates. The Companyestimates forfeitures based on historical termination behavior. For the years ended December 31, 2018, 2017 and 2016, forfeiture rates of 5% were appliedto both management and non-management grants. F-22Table of Contents The following table illustrates the number of ordinary shares and weighted-average exercise prices, or WAEP, of, and movements in, share options duringthe year: Numberof ordinaryshares WAEP Outstanding as of January 1, 2018 3,104,613 $11.62 Granted 796,264 13.37 Exercised (694,322) 4.67 Forfeited (643,386) 14.31 Outstanding as of December 31, 2018 2,563,169 13.37 Vested or expected to vest as of December 31, 2018 2,494,307 $13.37 Exercisable as of December 31, 2018 1,401,639 $13.47 The following table illustrates the number of restricted shares and RSUs, and weighted-average fair value, or WAFV, of, and movements in, restrictedshares and RSUs during the year: Number ofordinaryshares WAFV Unvested balance as of January 1, 2018 418,518 $14.93 Granted 166,008 13.37 Cancelled (112,694) 13.09 Vested (170,878) 16.98 Unvested balance as of December 31, 2018 300,954 13.88 As of December 31, 2018, there was $5.2 million and $3.0 million of total unrecognized compensation cost related to unvested share options andunvested restricted shares and RSUs, respectively, granted under the Plans. The cost for unvested share options and unvested restricted shares and RSUs isexpected to be recognized over weighted-average periods of 2.4 years and 2.6 years, respectively. The aggregate intrinsic value of all share options outstanding under the Plans as of December 31, 2018 and 2017 was $2.8 million and $10.7 million,respectively. The aggregate intrinsic value of share options that were exercisable under the Plans as of December 31, 2018 and 2017 was $2.4 million and$8.8 million, respectively. During the years ended December 31, 2018, 2017 and 2016, current and former employees of the Company exercised a total of 694,322, 500,182 and85,943 share options, respectively, resulting in total proceeds of $3.2 million during 2018, $561,000 during 2017 and $76,000 during 2016. The intrinsicvalue of share options exercised during the years ended December 31, 2018, 2017 and 2016 was $6.7 million, $7.2 million and $1.0 million, respectively.In accordance with Company policy, the shares were issued from a pool of shares reserved for issuance under the Plans described above. A summary of the activity of the Company’s unvested share options is as follows: Numberof shares Weighted-average grantdate fair value Balance as of December 31, 2017 1,479,293 $5.83 Granted 796,264 6.15 Vested (651,787) 5.59 Forfeited (462,240) 6.56 Balance as of December 31, 2018 1,161,530 6.06 The total fair value of shares vested for the years ended December 31, 2018, 2017 and 2016 was $3.7 million, $3.1 million and $2.9 million, respectively. F-23Table of Contents The impact on the Company’s results of continuing and discontinued operations from share-based compensation for the years ended December 31, 2018,2017 and 2016, was as follows: (in thousands) 2018 2017 2016 Cost of revenue $182 $168 $52 Research and development 758 654 497 Sales and marketing 965 1,844 1,671 General and administrative 2,602 3,005 2,681 Total continuing operations 4,507 5,671 4,901 Discontinued operations 1,044 193 118 Total share-based compensation $5,551 $5,864 $5,019 On September 10, 2018, the Company’s Board of Directors approved the modification of unvested equity awards awarded to approximately 35 employeesexpected to move to Quest. Per the terms of the modification, upon closing of the transaction, all outstanding awards became fully vested. The Companyaccounted for the modification as of September 25, 2018, when the Company signed the Purchase Agreement with Quest and the performance criteriabecame probable. At that time, all expense related to unvested awards was reversed, and the modified awards were revalued. The Company compared thefair value of the award immediately before and after the modification, and there was no incremental compensation to be recognized. Expense related to themodified awards was fully recognized on the closing date. Approximately 120,000 options and 28,100 RSUs were accelerated. For the year ended December 31, 2018, the Company incurred shared-based compensation expense related to share options and restricted shares and RSUsof approximately $3.6 million and $2.0 million, respectively. For the year ended December 31, 2017, the Company incurred shared-based compensationexpense related to share options, and restricted shares and RSUs of approximately $3.6 million and $2.2 million, respectively. For the year endedDecember 31, 2016, the Company incurred shared-based compensation expense related to share options and restricted shares of approximately $3.2million and $1.8 million, respectively. 12. Net income (loss) per ordinary share The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net income (loss) per share: Year ended December 31, ($ in thousands) 2018 2017 2016 Numerator: Income (loss) from continuing operations $12,505 $(33,226) $(21,578)Income (loss) from discontinued operations 108,274 341 (771)Net income (loss) $120,779 $(32,885) $(22,349) Denominator: Weighted-average ordinary shares outstanding-basic 25,982,809 23,757,902 22,353,713 Dilutive effect of ordinary share equivalents resulting from ordinary share options, unvestedrestricted shares and RSUs 415,066 — — Weighted-average ordinary shares outstanding-diluted 26,397,875 23,757,902 22,353,713 The following numbers of outstanding ordinary share options, restricted shares and RSUs were excluded from the computation of diluted net loss per sharefor the periods with a net loss because their effect would have been anti-dilutive: Year ended December 31, 2018 2017 2016 Options to purchase ordinary shares — 878,242 1,065,655 Unvested restricted shares and RSUs — 418,518 329,465 13. Income taxes The components of loss from continuing operations before income taxes are as follows for the years ended December 31: (in thousands) 2018 2017 2016 Domestic (United Kingdom) $12,623 $18,171 $(730)Foreign (United States) (37,404) (49,763) (24,622)Loss from continuing operations before income taxes $(24,781) $(31,592) $(25,352) F-24Table of Contents The components for the income tax (expense) benefit from continuing operations are as follows for the years ended December 31: (in thousands) 2018 2017 2016 Current: Federal $— $— $— U.K. (532) — — Japan (45) (14) (85)China (13) (39) (12)State — (46) (51)Total current provision (590) (99) (148)Deferred: Federal 30,665 — 752 U.K. (1,343) (1,535) 2,630 State 8,554 — 540 Total deferred benefit (expense) 37,876 (1,535) 3,922 Income tax benefit (expense) $37,286 $(1,634) $3,774 Intraperiod tax allocation rules require the Company to allocate the provision for income taxes between continuing operations and other categories ofearnings, such as discontinued operations and other comprehensive income. In periods in which the Company has a year-to-date pre-tax loss fromcontinuing operations and pre-tax income in other categories of earnings, such as discontinued operations, we must allocate the tax provision to the othercategories of earnings. As a result, the Company has recorded a tax expense of approximately $39.4 million in discontinued operations related to the saleof the Company’s U.S. Laboratory Services Business to Quest. A corresponding tax benefit has been recorded as part of continuing operations,representing the valuation allowance released on the beginning of the year net operating losses. The Company’s effective income tax rate differs from the statutory domestic (United Kingdom) income tax rate as follows for the years ended December31: 2018 2017 2016 Income tax rate 19.0% 19.3% 20.0%U.K. research and development credit 1.8 1.5 1.9 Effect of U.S. tax reform – Federal tax rate change — (69.2) — Permanent items 1.0 5.9 (1.9)Prior period adjustments (5.2) — — State taxes 9.2 9.6 4.9 Other 2.0 4.6 (1.5)Effect of foreign tax rate differential 2.9 28.0 13.1 Uncertain tax positions (1.7) — — Valuation allowance 121.5 (5.0) (21.6)Effective income tax rate 150.5% (5.3)% 14.9% The Company is headquartered in the United Kingdom and the statutory U.K. corporate tax rate for the years ended December 31, 2018, 2017 and 2016was 19.0%, 19.3% and 20.0%, respectively. The U.S. federal corporate tax rate for the years ended December 31, 2018, 2017 and 2016 was 21%, 34% and34%, respectively. The Company is subject to taxation in the U.S. and various state, local and foreign jurisdictions. The Company remains subject toexamination by various tax authorities for tax years 2015 through 2018. With a few exceptions, the Company is no longer subject to examinations by taxauthorities for the tax years 2014 and prior. However, net operating losses from the tax years 2014 and prior would be subject to examination if and whenused in a future tax return to offset taxable income. The Company’s policy is to recognize income tax related penalties and interest, if any, in its provisionfor income taxes and, to the extent applicable, in the corresponding income tax assets and liabilities, including any amounts for uncertain tax positions. The United Kingdom’s Summer Finance Bill, which was enacted on September 15, 2016, contained reductions in corporation tax to 19% from April 1,2017 and 17% from April 1, 2020. The Company has measured its U.K. deferred taxes at the statutory tax rate of 17%, reflecting the anticipated timing ofthe reversal of its deferred tax balances. F-25Table of Contents Deferred income taxes reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reportingpurposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and deferred tax liabilities are asfollows for the years ended December 31: (in thousands) 2018 2017 Deferred tax assets: U.S. federal net operating losses $11,478 $33,713 State net operating loss (net of federal) 2,865 8,450 U.S. federal research and development credit 849 587 U.K. net operating loss 496 1,894 Share options 1,724 2,611 Accrued liabilities 1,052 393 Intangible assets — 2,392 State credits 512 377 Other 136 167 Total deferred tax assets 19,112 50,584 Valuation allowance (17,991) (48,098)Total deferred tax assets $1,121 $2,486 Deferred tax liabilities: Other assets $(69) $— Total deferred tax liabilities $(69) $— On December 22, 2017, the Tax Cuts and Jobs Act of 2017, or the TCJA, was enacted. This tax reform legislation makes significant changes in U.S. taxlaw including a reduction in the corporate tax rates, changes to net operating loss carryforwards and carrybacks, and a repeal of the corporate alternativeminimum tax. The legislation reduced the U.S. corporate tax rate from the current rate of 34% to 21% effective on January 1, 2018. As a result of theenacted law, the Company was required to revalue deferred tax assets and liabilities at the 21% rate. This resulted in a decrease in the company’s netdeferred tax asset and corresponding valuation allowance of $21.4 million. As the Company maintained a full valuation allowance against its net deferredtax asset position in the United States, this revaluation did not result in an income tax expense or benefit in the prior period. The other provisions of theTCJA did not have a material impact on the 2017 or 2018 consolidated financial statements. For the years ended December 31, 2018 and 2017, the Company had United Kingdom Net Operating Losses (U.K. NOLs) of $2.9 million and $11.1million, respectively. U.S. federal net operating loss carry forwards for the years ended December 31, 2018 and 2017 were $54.7 million and $160.5million, respectively. U.S. State net operating loss carryforwards for the years ended December 31, 2018 and 2017 were $50.3 million and $154.9 million,respectively. The U.S. federal and state net operating loss carryforwards begin to expire in 2019 and 2019, respectively and the U.K. NOLs can be carried forwardindefinitely. For the year ended December 31, 2018, the Company continues to recognize its deferred tax assets in the U.K. related to OI Limited. The Company alsocontinues to recognize the deferred tax asset for future share based deductions related to OI Global. The Company has determined that it is more likelythan not that this asset of $1.1 million will be realized in the future. The Company continues to record a full valuation allowance against all other netdeferred tax assets since it is not ‘more likely than not’ that these amounts will be realized. The following table reflects the rollforward of the Company’s valuation allowance: (in thousands) 2018 2017 2016 Beginning of year (January 1) $48,098 $46,473 $43,076 (Decrease) increase in valuation allowance (30,107) 1,625 3,397 End of year (December 31) $17,991 $48,098 $46,473 Interest and penalties related to uncertain tax positions are recorded in tax expense and totaled $37,000, $0 and $0 for the years ended December 31,2018, 2017 and 2016, respectively. The liability recorded for potential penalties and interest was $37,000 and $0 as of December 31, 2018 and 2017,respectively. The Company had a total recorded liability of $409,000 and $0 related to uncertain tax positions, inclusive of penalties and interest, as ofDecember 31, 2018 and 2017, respectively, which is included in accrued liabilities in the consolidated balance sheets. The Company did not have any gross uncertain tax positions prior to December 31, 2017. The aggregate changes in the balance of gross uncertain tax positions, which excludes interest and penalties, for the year ended December 31, 2018 wereas follows (in thousands): Balance at December 31, 2017 $— Settlement/decreases related to tax positions taken during prior years — Increases related to tax positions taken during prior years 372 Increases related to tax positions taken during the current year — Balance at December 31, 2018 $372 F-26Table of Contents The Company generates research and development credits in the United Kingdom which are refundable if a current year loss is incurred. In the UnitedKingdom for the year ended December 31, 2018, no amounts were reimbursed for research and development tax credits. The SEC staff issued SAB 118 which allowed the Company to record provisional amounts for the impact of the TCJA during a measurement period whichis similar to the measurement period used when accounting for business combinations. At December 31, 2017, the Company made a reasonable estimateof the effects of the TCJA on our existing deferred tax balances. As of December 31, 2018 the Company has completed its review of the TCJA and notedno material changes to our initial assessment. 14. Intellectual property—license agreements The Company entered into three license agreements by which it has secured certain patent rights that are necessary to make, use and sell the T-SPOT.TBtest. In November 2013, one of these license agreements, with Oxford Innovation, was terminated in connection with the assignment by OxfordInnovation to the Company of certain intellectual property rights. The Company has ongoing obligations to make certain payments to Oxford Innovationwhile the assigned patents remain in force in certain countries. On June 30, 2017, we entered into a Release and Settlement Agreement, or the Settlement Agreement, with Statens Serum Institut, or SSI, to resolveoutstanding disputes arising from the license agreement with SSI. The terms of the Settlement Agreement are confidential. Based on the SettlementAgreement, we no longer expect to pay royalties to SSI. The Company’s existing license agreements related to its T-SPOT.TB test, as well as its previous license from Oxford Innovation, are generally exclusivein the stated field, cover a worldwide territory, are royalty-bearing and give the Company the right to grant sublicenses. The Company has minimumroyalty obligations under each existing license agreement, which continue so long as patents licensed under the agreement remain unexpired. Theminimum contractual royalty payments, including ongoing minimum payment obligations to Oxford Innovation after December 31, 2018 are set forth inthe license agreements and supplier purchase obligations table in Note 16. Commitments and contingencies, to these consolidated financial statements. The Company incurs royalties under each existing license agreement, has incurred royalties under the Oxford Innovation license agreement, and willincur continuing payment obligations to Oxford Innovation that are treated as royalties in these financial statements, based on its product and servicerevenue. The aggregate royalty expense relating to the three license agreements amounted to $1.1 million, $2.8 million and $5.2 million for the yearsended December 31, 2018, 2017 and 2016, respectively. The Company paid other license-related expenses, including patent prosecution expenses,milestone payments and assignment fees due to these licensors, amounting to $83,000, $80,000 and $161,000 for the years ended December 31, 2018,2017 and 2016, respectively. The aggregate royalty rate paid by the Company in the years ended December 31, 2018, 2017 and 2016, as a percentage ofthe gross product and service revenue of the Company, was 2%, 5% and 11%, respectively. 15. Employee benefit plans In the United States, the Company has adopted a defined contribution plan (the U.S. Plan) which qualifies under Section 401(k) of the Internal RevenueCode. All U.S. employees of the Company who have attained 21 years of age are eligible for participation in the U.S. Plan upon employment. Theeffective date of the U.S. Plan was January 1, 2008. Under the U.S. Plan, participating employees may defer up to the Internal Revenue Service annualcontribution limit. The Company began matching employee contributions as of July 1, 2016 and paid $314,000, $277,000 and $126,000 in matchingcontributions in the years ended December 31, 2018, 2017 and 2016, respectively. In the United Kingdom, the Company has adopted a defined contribution plan (the U.K. Plan) which qualifies under the rules established by HMRevenue & Customs. The U.K. Plan allows all U.K. employees to contribute a minimum of 5% of salary with no maximum limit. The contribution ismatched by the Company, up to a maximum of 5% of salary. The Company paid to the U.K. Plan $685,000 in contributions in the year endedDecember 31, 2018, $613,000 in the year ended December 31, 2017 and $636,000 in the year ended December 31, 2016. F-27Table of Contents 16. Commitments and contingencies Operating leases At December 31, 2018, the Company leases facilities under seven non-cancelable operating leases, with terms that expire between 2019 and 2033. TheCompany leases office, storage/warehouse, laboratory and manufacturing space in Abingdon, U.K., which leases are due to expire at various dates fromJune 11, 2019 to June 18, 2033. On March 1, 2013, the Company signed a five year lease for its U.S. corporate headquarters in Marlborough,Massachusetts. In August 2015, the Company entered into a lease amendment for this location to extend the term of the lease by two years throughOctober 31, 2020. In addition, the lease amendment expanded the Company’s office space at this location by 7,600 square feet to a new total of 22,100square feet. The base rent for the combined space over the lease term will range from an initial low of $36,000 per month, which includes $12,000 permonth for the expansion space commencing in early 2016, to a high of $39,000 per month. The Company will have an option to extend the lease for oneadditional term of five years. In connection with the sale of our U.S. Laboratory Services Business to Quest, we entered into a sublease with Quest for approximately 9,000 square feetof warehousing and office space in Norwood, Massachusetts. The sublease expires in November 2020. The base rent for the space subject to sublease isapproximately $17,000 per month. In June 2018, the Company entered into a lease for new space in Abingdon, England, which extends through June 2033 that will allow it to combine itsmanufacturing, laboratory, storage and office operations into a single facility. The base rent on the facility over the lease term will range from $39,000 permonth to $79,000 per month. Select functional groups began moving into the facility during the third quarter of 2018. Future minimum lease payments required under the non-cancelable operating leases in effect as of December 31, 2018 are as follows: (in thousands) December 31,2018 2019 $2,024 2020 1,848 2021 972 2022 855 2023 855 Thereafter 7,558 Total minimum lease payments $14,112 Rent expense is calculated on a straight-line basis over the term of the lease. Rent expense recognized under operating leases totaled $2.3 million, $1.6million and $1.1 million for the years ended December 31, 2018, 2017 and 2016, respectively. Purchase commitments The Company has license agreements with third parties that provide for minimum royalty, license, and exclusivity payments to be paid by the Companyfor access to certain technologies. In addition, the Company pays royalties as a percent of revenue as described in Note 14. Intellectual property—licenseagreements, to these consolidated financial statements. In addition, the Company has outstanding purchase obligations to its suppliers. Future minimum payments required under license agreements and supplier purchase obligations in effect as of December 31, 2018 are as follows: (in thousands) Licenseagreements Supplierpurchaseobligations Total 2019 $262 $8,723 $8,985 2020 134 — 134 2021 59 — 59 2022 59 — 59 2023 59 — 59 Thereafter 695 — 695 Total minimum payments $1,268 $8,723 $9,991 Legal contingencies The Company is subject to claims and assessments from time to time in the ordinary course of business. The Company does not believe that any suchmatters, individually or in the aggregate, will have a material adverse effect on the Company’s business, financial condition, results of operations or cashflows. F-28Table of Contents Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and providefor general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against theCompany in the future, but that have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to itsindemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. In accordance with its articles of association, the Company has indemnification obligations to its officers and directors for certain events or occurrences,subject to certain limits, while they are serving at the Company’s request in such capacity. There have been no claims to date, and the Company hasdirector and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims. 17. Geographic revenue and long-lived assets distribution The Company is domiciled in the United Kingdom and operates in three geographies: the United States, Europe and the Rest of the World (ROW), andAsia. Following is geographical information regarding the Company’s revenues for the years ended December 31, 2018, 2017 and 2016 and theCompany’s long-lived assets as of December 31, 2018 and 2017. Revenue Long-lived assets Years ended December 31, As of December 31, (in thousands) 2018 2017 2016 2018 2017 United States $16,442 $15,720 $10,372 $1,685 $1,071 United Kingdom 3,626 3,041 2,620 5,248 1,487 Europe and ROW (excluding United Kingdom) 5,527 5,095 4,368 101 132 Europe and ROW 9,153 8,136 6,988 5,349 1,619 Asia 34,158 30,877 29,628 110 74 Total $59,753 $54,733 $46,988 $7,144 $2,764 China represented approximately 48%, 46% and 44% of Asia revenue in 2018, 2017 and 2016, respectively. Japan represented approximately 50%, 51%and 55% of Asia revenue in 2018, 2017 and 2016, respectively. 18. Acquisition activity Imugen, Inc. On July 1, 2016, the Company acquired substantially all of the assets of Imugen, a privately owned Massachusetts corporation focused on thedevelopment and performance of testing for tick-borne diseases. The assets acquired primarily related to Imugen’s proprietary testing technology and itsClinical Laboratory Improvements Amendment, or CLIA, approved and College of American Pathologists, or CAP, approved laboratory in Norwood,Massachusetts. The consideration for the acquisition of Imugen consisted of $22.2 million in cash. The Company filed the required financial statements (including proforma financial statements) relating to the acquisition on a Form 8-K/A on September 9, 2016. The acquisition of Imugen was accounted for under the acquisition method of accounting and the purchase price allocation was provisionally preparedduring the third quarter of 2016. These provisional amounts were finalized during the fourth quarter of 2016. The table below summarizes the purchase price of the Imugen acquisition and the fair value of identified assets acquired at the acquisition date (inthousands): Assets acquired: Property and equipment $655 In-process research and development 9,200 Technology - clinical 5,100 Customer relationships 2,700 Trademarks / trade names 1,900 Total assets acquired 19,555 Add: Goodwill 2,645 Total consideration transferred $22,200 F-29Table of Contents On the date of the acquisition, the fair value of acquired intangible assets was determined to be $18.9 million using primarily the excess earnings methodwith significant inputs that are not observable, including estimates of the timing and cost required for product approval, revenue growth, gross margin,operating expenses and a discount rate of approximately 22%. These intangible assets were considered to be Level 3 fair value assets due to thesignificant estimates and assumptions used by management in establishing the estimated fair value. Goodwill of approximately $2.6 million represented the excess of the purchase price of the acquired business over the fair value of the underlying nettangible and identifiable intangible assets and represented the expected synergistic benefits of the transaction, which related to an increase in futurerevenues for the Company as a result of leveraging Imugen’s systems and expertise of its employees. The goodwill also related to the knowledge andexperience of the workforce in place. Goodwill and IPR&D are indefinite-lived intangible assets and are not amortized. Rather, they are reviewed forimpairment at least annually. Goodwill related to the Imugen acquisition is deductible for tax purposes over a period of 15 years. During the year ended December 31, 2016, the Company incurred transaction costs of $475,000 associated with the acquisition of Imugen that wererecorded within general and administrative expense in the statement of operations. Actual results of operations for the year ended December 31, 2016 acquired from Imugen are included in the consolidated financial statements from thedate of the acquisition, including revenues in the amount of $7.0 million and income from operations of $730,000, not including transaction costs. See Note 7. Goodwill and intangible assets for information regarding impairment charges recorded on the intangible assets recorded in the acquisition ofImugen. With the exception of the blood donor screening business, the bulk of the remaining assets acquired from Imugen were sold to Quest in the Transaction. Immunetics, Inc. On October 12, 2016, the Company, through its indirect subsidiary, Oxford Immunotec, Inc., acquired Immunetics, a Massachusetts based diagnosticscompany focused on developing specialized tests for infectious diseases, including tick-borne diseases, such as Lyme disease. The assets acquiredprimarily related to IPR&D for a test for Babesia, fixed assets, customer relationships, the “Immunetics” trade name, Immunetics’ proprietary testingtechnology for Lyme disease, and various government grants in progress at the time. Total consideration consisted of $6.0 million in cash and up to an additional $6.0 million in cash payable on the achievement of certain revenuethresholds and pipeline related milestones over the following three years. The acquisition of Immunetics was accounted for under the acquisition method of accounting and the purchase price allocation was provisionallyprepared during the fourth quarter of 2016. In the second quarter of 2017, the Company finalized the accounting for the acquisition and recorded thefollowing measurement period adjustments: ●the fair value of the acquired inventory decreased by $45,000 with corresponding increases to the clinical technology asset of $22,500 and togoodwill of $22,500 ●the fair value of the acquired customer relationships decreased by $50,000 with a corresponding increase to goodwill ●the fair value of the Immunetics trade name decreased by $130,000 with a corresponding increase to goodwill ●goodwill decreased by $58,000 due to changes in deferred taxes The impact on the consolidated statement of operations for the year ended December 31, 2016 was a $44,000 reduction in cost of product revenue, a$26,000 reduction in sales and marketing expense and a $58,000 increase in income tax expense. The Company paid approximately $655,000 in transaction costs associated with this transaction, which was included in general and administrativeexpense in the statement of operations for the year ended December 31, 2016. Total consideration was (in thousands): Cash consideration $6,000 Estimated fair value of contingent consideration 3,444 Total consideration transferred $9,444 F-30Table of Contents The table below summarizes the final purchase price allocation for the Immunetics acquisition (in thousands): Assets acquired: Cash $285 Accounts receivable, net 347 Inventory, net 375 Prepaid expenses and other assets 199 Property and equipment 787 In-process research and development 6,970 Customer relationships 350 Trade name 160 Technology – clinical 883 Grants 50 Total assets acquired 10,406 Liabilities assumed: Accounts payable (319)Accrued liabilities (739)Other liabilities (1,226)Total liabilities assumed (2,284)Net assets acquired 8,122 Add: Goodwill 1,322 Total consideration transferred $9,444 On the date of the acquisition, the fair value of acquired intangible assets was determined to be $8.4 million using primarily the excess earnings methodwith significant inputs that are not observable, including estimates of the timing and cost required for product approval, revenue growth, gross margin,operating expenses and discount rate rates ranging between 21.6% and 60.2%, depending on the levels of risk inherent in the various intangibleassets. We considered these intangible assets to be Level 3 fair value assets due to the significant estimates and assumptions used by management inestablishing the estimated fair value. Actual results of operations for the year ended December 31, 2016 acquired from Immunetics were included in the consolidated financial statements fromthe date of the acquisition, including revenues in the amount of $392,000 and loss from operations of $813,000, not including transaction costs. Goodwill of approximately $1.3 million represented the excess of the purchase price of the acquired business over the fair value of the underlying nettangible and identifiable intangible assets and represented the expected benefits of the transaction, which related to an increase in future revenues for theCompany as a result of leveraging Immunetics’ systems and expertise of its employees. The goodwill was also related to the knowledge and experience ofthe workforce in place. Goodwill is an indefinite-lived intangible asset and is not amortized. Rather, it is reviewed for impairment at least annually. Therewas no evidence of any goodwill impairment at December 31, 2018 and there were no goodwill impairment charges during the year ended December 31,2018. The goodwill recognized was not deductible for tax purposes. See Note 7. Goodwill and intangible assets for information regarding impairment charges recorded on the intangible assets recorded in the acquisition ofImmunetics. The remaining definite-lived intangible assets recorded in the acquisition of Immunetics were written-off in the fourth quarter of 2018, as a result of theCompany’s change in strategic focus following the Transaction with Quest. 19. Discontinued operations As previously disclosed, on September 25, 2018, Oxford Immunotec Global PLC (the “Company”), entered into a Limited Liability Company InterestPurchase Agreement (the “Purchase Agreement”) with Quest Diagnostics Incorporated, a Delaware corporation (“Quest”), Oxford Immunotec Limited, alimited company incorporated in England and Wales and a wholly owned subsidiary of the Company (“Oxford Limited”) and Oxford Immunotec, LLC, aDelaware limited liability company (formerly known as Oxford Immunotec, Inc., a Delaware corporation) and a wholly owned subsidiary of the Company(“Oxford LLC”), pursuant to which Oxford Limited agreed to sell, and Quest agreed to acquire, the Company’s U.S. laboratory services business (the “U.S.Laboratory Services Business”) for gross proceeds of $170 million in cash (the “Transaction”). Of this amount, approximately $32.3 million was paiddirectly to MidCap in settlement of all amounts due, which included prepayment and exit fees of approximately $2.3 million as described in Note 9.Loans payable. As contemplated in the Purchase Agreement, Oxford Immunotec USA, Inc., a Delaware corporation and a newly formed wholly owned subsidiary ofOxford Limited (“Oxford USA”), joined the Purchase Agreement by way of a Joinder Agreement dated October 1, 2018. F-31Table of Contents The Transaction was consummated in accordance with the terms and conditions of the Purchase Agreement on November 6, 2018, or the Closing Date.Prior to and in connection with consummation of the Transaction, Oxford USA and Oxford LLC carried out a corporate restructuring pursuant to which (i)the assets and businesses of Oxford LLC other than the U.S. Laboratory Services Business were transferred to Oxford USA and (ii) Oxford LLC wasconverted into a limited liability company. The U.S. Laboratory Services Business at the time of the sale had a carrying value of $27.9 million. We recorded a gain of $146.0 million, which amountis included in income (loss) from discontinued operations before income taxes in our consolidated statement of operations for the year ended December31, 2018. Additionally, pursuant to the terms of the Purchase Agreement, the parties entered into certain ancillary agreements as of the Closing Date, including: (i) atransitional services agreement, or TSA, that will continue, unless otherwise terminated, until each service included in the TSA has been completed, (ii) atechnology license agreement that will remain in effect until the date of expiration or lapse of the last to expire or lapse Blood Stability Patent and (iii) along-term supply agreement, or the Supply Agreement, pursuant to which Oxford USA agreed to sell, and Quest agreed to purchase, T-SPOT.TB test kitsand related accessories from Oxford USA. The Supply Agreement will last for a period of seven years after the effective date, unless a party to the SupplyAgreement terminates it early, as provided for in the Supply Agreement. In addition, the parties entered into a strategic collaboration agreement to drivecontinued growth of T.SPOT.TB testing in the U.S. that will remain in effect until the expiration or termination of the Supply Agreement. In conjunction with the Purchase Agreement, Quest has agreed to purchase kits and accessories from the Company for an initial period of seven years afterthe effective date of the Purchase Agreement unless a party to the Purchase Agreement earlier terminates, as provided for in the Purchase Agreement. During the year ended December 31, 2018 and 2017, Oxford Immunotec Limited sold kits to its discontinued operations, Oxford Immunotec, Inc. for usein the lab services business of $8.0 million and $8.4 million, respectively, that were eliminated in the Company’s consolidated results. Transaction expenses of $3.3 million, primarily comprised of investment banking, legal, and accounting fees related to the pending disposition, wereincluded in general and administrative expense for the year ended December 31, 2018. The table below provides a reconciliation of the carrying amounts of major classes of assets and liabilities of the discontinued operations that aredisclosed in these notes to the consolidated financial statements to the total assets and liabilities of the disposal group classified as assets and liabilities ofdiscontinued operations that are presented separately in the consolidated balance sheets. The assets and liabilities of the disposal group presented asassets and liabilities of discontinued operations have been reclassified in the Company’s consolidated balance sheet as of December 31, 2017. December 31, (in thousands) 2017 Carrying amounts of major classes of assets included as part of discontinued operations: Accounts receivable, net $10,961 Inventory, net 3,005 Prepaid expenses and other assets 315 Total major classes of current assets of the discontinued operations 14,281 Property and equipment, net 6,303 Goodwill 1,484 Other intangible assets, net 6,813 Other assets 185 Total major classes of noncurrent assets of the discontinued operations 14,785 Total assets of the disposal group classified as assets of discontinued operations in the consolidated balance sheets $29,066 Carrying amounts of major classes of liabilities included as part of discontinued operations: Current liabilities: Accounts payable $1,290 Accrued liabilities 3,326 Other liabilities 14 Total major classes of current liabilities of the discontinued operations 4,630 Total major classes of noncurrent liabilities of the discontinued operations 48 Total liabilities of the disposal group classified as liabilities of discontinued operations in the consolidated balance sheets $4,678 F-32Table of Contents The following table presents the results of discontinued operations: Year Ended December 31, (in thousands) 2018 2017 2016 Major classes of line items constituting income (loss) from discontinued operations beforeincome taxes: Service revenue $53,325 $56,700 $45,705 Cost of service revenue 34,662 36,613 29,596 Gross profit 18,663 20,087 16,109 Research and development 5,751 5,866 4,542 Sales and marketing 7,592 8,963 8,106 General and administrative 3,593 4,917 4,232 Income (loss) from discontinued operations before income taxes 1,727 341 (771)Gain on disposition 145,982 — — Income tax expense (39,435) — — Income (loss) from discontinued operations $108,274 $341 $(771) 20. Restructuring During the third quarter of 2017, the Company’s management committed to a plan to terminate various government grants that were acquired as part ofthe acquisition of Immunetics. As a result, the Company terminated 15 employees during the fourth quarter of 2017 and recorded restructuring charges of$169,000 in research and development expense and $13,000 in general and administrative expense. A summary of these charges and payments made to date are included in the below table. Accrued restructuring costs at December 31, 2018 and 2017 areincluded in accrued liabilities in the accompanying balance sheet. (in thousands) Severance Balance at December 31, 2016 $— Charge for restructuring 182 Payments during 2017 (108)Balance at December 31, 2017 74 Payments during 2018 (70)Balance at December 31, 2018 $4 In addition to the items listed above, the Company recorded charges in the third quarter of 2017 of $28,000 to write-off equipment having no futurebenefit to the Company and $26,000 to write-off the unamortized balance of the grant intangible. 21. Settlement expense On June 18, 2018, the Company entered into a Settlement Agreement with the former shareholders of Immunetics, Inc., or the Immunetics SettlementAgreement, to resolve disputes arising from the Agreement and Plan of Merger dated October 12, 2016. The terms of the Immunetics SettlementAgreement are confidential. The Company has no further obligations under the Immunetics Settlement Agreement. On June 30, 2017, the Company and Statens Serum Institut, or SSI, entered into a Release and Settlement Agreement, or the SSI Settlement Agreement, toresolve outstanding disputes arising from the license agreement with SSI. The terms of the SSI Settlement Agreement are confidential. 22. Litigation settlement income In December 2017, as part the settlement of the Company’s patent infringement action, the Company received a one-time, lump sum payment of $27.5million from Qiagen. The income from the settlement was recorded as a separate item in the other income (expense) section of the Company’sconsolidated statement of operations. See “Legal Proceedings” for more information. F-33Table of Contents 23. Subsequent events Effective March 5, 2019, the Remuneration Committee of the Board of Directors approved the grant of equity awards to certain employees of theCompany, to be issued in the form of share options and restricted share units from the Oxford Immunotec Global PLC 2013 Share Incentive Plan. Thenumber of share options and restricted share units to be granted will be determined based on the closing price of the Company’s ordinary shares on thedate of grant. F-34 Exhibit 10.12 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. SUPPLIER AGREEMENT This Supplier Agreement (this “Agreement”) is entered into, effective as of January 1, 2019 (the “Effective Date”), by and between Millipore (U.K.)Ltd., an English company with its principal place of business at Suite 21, Building 6, Croxley Green Business Park, Watford, Hertfordshire WD18 8YH,UK (“Merck”), and Oxford Immunotec Limited, an English company with its principal place of business at 94C Innovation Drive, Milton Park, Abingdon,Oxfordshire, OX14 4RZ, UK (“Oxford” or “Customer”)). As used in this Agreement, “Party” means Merck or Customer, and “Parties” means, collectively,Merck and Customer. WITNESSETH: WHEREAS Merck is in the business of manufacturing, distributing and selling life science consumables, instrumentation and other products; and WHEREAS Customer is interested in purchasing and utilizing certain Merck products, all in accordance with the terms of this Agreement. NOW, THEREFORE, in consideration of the mutual promises and covenants set forth herein, the Parties hereto agree as follows: 1.DEFINITIONS 1.1.“Additional Orders” has the meaning set forth in Section 4.3. 1.2.“Affiliate” means, with respect to a Party, any corporation, company, partnership, joint venture and/or firm that controls, is controlled by oris under common control with such Party. As used in this definition, “control” means (a) in the case of a corporate entity, direct or indirectownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of anon-corporate entity, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect more than fifty percent (50%) of the members of the governing body of such non-corporate entity. 1.3.“Agreement” has the meaning set forth in the preamble of this Agreement. 1.4.“Binding Forecast” has the meaning set forth in Section 4.1. 1.5.“Commercial Forecast” has the meaning set forth in Section 4.1. -1- 1.6.“Confidential Information” has the meaning set forth in Section 6.1. 1.7.“Customer” has the meaning set forth in the preamble of this Agreement. 1.8.“Customer Indemnified Party” has the meaning set forth in Section 7.2. 1.9.“Discloser” has the meaning set forth in Section 6.1. 1.10.“Effective Change Date” has the meaning set forth in Section 4.7(a). 1.11.“Effective Date” has the meaning set forth in the preamble of this Agreement. 1.12.“Federal healthcare programs” has the meaning set forth in Section 8.4. 1.13.“Finished Product” has the meaning set forth in Section 7.1(d). 1.14.“Force Majeure Event” has the meaning set forth in Section 11.6. 1.15.“Indemnified Party” has the meaning set forth in Section 7.3. 1.16.“Indemnifying Party” has the meaning set forth in Section 7.3. 1.17.“List Price” has the meaning set forth in Section 2.1. 1.18.“Losses” has the meaning set forth in Section 7.1. 1.19.“Material Change” has the meaning set forth in Section 4.7. 1.20.“Merck” has the meaning set forth in the preamble of this Agreement. 1.21.“Merck Indemnified Party” has the meaning set forth in Section 7.1. 1.22.“Non-Binding Forecast” has the meaning set forth in Section 4.1. 1.23.“Non-Conforming Additional Orders” has the meaning set forth in Section 4.3. 1.24.“Order Date” or “Order Dates” have the meaning set forth in Section 4.2. 1.25.“Oxford” has the meaning set forth in the preamble of this Agreement. 1.26.“Party” or “Parties” has the meaning set forth in the preamble of this Agreement. 1.27.“Price” has the meaning set forth in Section 2.1. 1.28.“Product(s)” has the meaning set forth in Section 2.1. 1.29.“Product Warranty” has the meaning set forth in Section 8.1(A). 1.30.“Purchase Order” has the meaning set forth in Section 4.2. 1.31.“Recipient” has the meaning set forth in Section 6.1. -2- 1.32.“Site” has the meaning set forth in Section 2.2. 1.33.“Specifications” means the written specifications for each Product as set forth on Exhibit B attached hereto. 1.34.“Taxes” has the meaning set forth in Section 3.2. 1.35.“Term” has the meaning set forth in Section 9.1. 1.36.“Termination for Convenience” has the meaning set forth in Section 9.2. 1.37.“Third Party” means any person or entity other than Merck, Customer or their respective Affiliates. 1.38.“Warranty Period” has the meaning set forth in Section 8.1(A). 2.PRODUCTS Products. During the Term, and subject to the covenants, terms and conditions of this Agreement, Customer agrees to buy from Merck, and Merckagrees to sell to Customer, the Merck products set forth in Exhibit A attached to this Agreement (the “Products”) at the prices for such Products setforth on Exhibit A as such prices may be changed in accordance with the terms of this Agreement (the “Price”). The list of Products to be includedin Exhibit A may be modified at any time during the Term by mutual written agreement of the Parties. 3.PRICING 3.1.Price; Payment Terms. For each Product purchased pursuant to this Agreement, Merck shall invoice Customer, and Customer shall payMerck, the Price. Merck shall invoice Customer upon each shipment of Product, and Customer shall pay Merck in full within thirty (30) daysof invoice date. An interest charge equal to [***]% per month ([***]% per year) will be added to invoices outstanding beyond forty-five (45)days of the invoice date. In the event Customer’s account is overdue for a period of more than sixty (60) days or Customer otherwise has anunsatisfactory credit or payment record, Merck reserves the right in its reasonable discretion to (a) require C.O.D. payment terms, (b) refuse toship any accepted Purchase Order until overdue accounts are paid in full and/or (c) increase the Price. 3.2.Taxes. All amounts to be paid by Customer are exclusive of any applicable taxes, duties, customs, imports, levies or any other fee of anynature imposed by any federal, state or local government authority including, but not limited to, any VAT, excise and sales taxes(collectively “Taxes”), which Taxes will be payable by Customer. In the event Merck is required to prepay any such Taxes, Customer willreimburse Merck within thirty (30) days after receipt of an invoice from Merck. -3- 3.3.Packaging Costs. All Prices are based upon Customer Purchase Orders in standard commercial packaging. Any Customer requests for non-standard packaging may result in additional charges. 3.4.Adjustment to Price. Once per calendar year during the Term, but no earlier than the first anniversary of the Effective Date, Merck mayincrease the Price as further set forth below by providing Customer thirty (30) days prior written notice. Any such Price increase shall only beeffective as to Purchase Orders placed after the effective date of the Price increase and shall not exceed the greater of: (i) [***] ([***]%)percent; or (ii) the UK RPIX for the preceding twelve (12) months (UK Retail Price Index excluding mortgage interest – see Office ofNational Statistics at http://www.ons.gov.uk/ons/key-figures/index.html. Merck shall review Customer’s Product purchases in connectionwith its annual Price adjustment described above and if such Product purchases are [***] percent ([***]%) or more lower during the mostrecently completed calendar year than Product purchases in the prior calendar year, notwithstanding the foregoing, Merck reserves the rightto increase Price in excess of the limits set forth above, to a maximum of [***] percent ([***]%). 4.FORECASTS; ORDERING; PRODUCT CHANGES 4.1.Forecasts. No later than October 1 of each calendar year during the Term, Oxford shall provide Merck with a non-binding, written, annualforecast of its intended Product purchases for the forthcoming calendar year (the “Commercial Forecast”). After delivery of the initialCommercial Forecast for each calendar year, Customer shall deliver to Merck an updated Commercial Forecast on a calendar quarterly basis,which update shall include the next successive calendar quarter added to the last period of the previous Commercial Forecast. 4.2.Purchase Orders. No later than January 1, April 1, July 1 and October 1 (each an “Order Date” and collectively the “Order Dates”) of eachcalendar year during the Term, Oxford shall provide Merck with its written, binding and irrevocable purchase order (each individually a“Purchase Order” and collectively the “Purchase Orders”) for Products for the next calendar quarter (e.g., Purchase Order submitted onJanuary 1 will correspond to the calendar quarter beginning on April 1). In the event Customer does not require Products in a given calendarquarter and thus does not wish to order any, Customer shall notify Merck of same in writing on the applicable Order Date. Each PurchaseOrder shall specify the following: (a) the quantity and description of each Product ordered, with a minimum Purchase Order quantity of [***]Products per Purchase Order (assuming Oxford is ordering Product for such calendar quarter); (b) the address of the delivery site; (c) therequested delivery date(s), which delivery date shall not be less than eight (8) weeks from the date of the Purchase Order. In the event thePurchase Order exceeds [***] Products, Merck may, in its sole discretion, extend the delivery date an additional seven (7) weeks for a total offifteen (15) weeks from the date of the Purchase Order. Merck shall promptly confirm each Purchase Order in writing which shall be deemedits acceptance of such Purchase Order in accordance with the terms and conditions of this Agreement. For the purposes of the provisions inthis Agreement concerning confirmation and acceptance of Purchase Orders, “promptly” shall mean no later than ten (10) working daysfollowing Merck’s receipt of the applicable Purchase Order. In the event Customer identifies an error in Merck’s confirmation andacceptance of a Purchase Order, Merck will promptly correct such error after receipt of written notice from Customer. Merck is not obliged todeliver, and Customer is not obliged to purchase, any Products other than those set forth on Purchase Orders that have been accepted byMerck. Purchase Orders may be placed on Customer’s Purchase Order form, but any terms on such form that are in addition to or differentfrom the terms of this Agreement will be of no force or effect. -4- 4.3.Additional Orders. Merck shall promptly confirm in writing and thereby accept Purchase Orders in addition to those placed by Customer onor by the Order Dates (“Additional Orders”), except when: (a) such Additional Orders exceed [***] Products; (b) Oxford has placed more thantwo (2) Additional Orders during any calendar quarter; or (c) cumulative Purchase Orders in any calendar year during the Term exceed [***]Products (collectively, the “Non-Conforming Additional Orders”). In each case Merck may, in its sole discretion, promptly confirm inwriting and thereby accept such Non-Conforming Additional Orders and/or indicate in such written confirmation different delivery dates forthe Products set forth in such Non-Conforming Additional Orders; provided, however, that such dates shall be within a commerciallyreasonable timeframe. To the extent any such Non-Conforming Additional Orders are confirmed in writing and thereby accepted by Merck, itshall be obligated to fulfill the applicable Non-Conforming Additional Orders within the delivery date indicated in the applicable writtenconfirmation. 4.4.No Order Cancellation. Purchase Orders may not be cancelled under any circumstances, unless otherwise agreed in writing by the Parties. 4.5.Rescheduling of Orders. Oxford may reschedule the delivery dates of any Purchase Order at any time prior to the shipment date by providingreasonable advance written notice to Merck, provided that the newly rescheduled delivery date is no later than thirty (30) days after theoriginal delivery date. Merck shall use commercially reasonable efforts to accommodate such rescheduling. -5- 4.6.Product Acceptance and Returns. (a)Acceptance. Oxford shall be responsible for inspecting all Products shipped hereunder prior to acceptance; provided however, that ifOxford shall not have given Merck written notice of rejection within thirty (30) days following shipment to Oxford, the Products shallbe deemed to have been accepted by Oxford. Acceptance shall not be deemed to be a waiver or limitation of Merck’s obligationspursuant to this Agreement (or any breach thereof), including those obligations with respect to Merck’s Product warranty and Merck’sduty to indemnify Oxford as set forth below. (b)Returns. No Product shipped under this Agreement may be returned without the express prior written authorization of Merck, whichmay be withheld in Merck’s reasonable discretion. Merck shall pay any shipping costs associated with returning rejected Products. AtMerck’s reasonable discretion, and as Oxford’s sole remedy, Merck shall promptly either refund or replace any Products rejected byOxford and confirmed by Merck. 4.7.Product Change. In the event of a change in the manufacturing, form, fit, function, testing or documentation of any Product, that couldreasonably be expected to materially impact the performance or Specifications of the Product (a “Material Change”), Merck shall use bestefforts to notify Oxford of such changes at least six (6) months prior to the Effective Change Date. Notwithstanding the foregoing, on rareoccasions Merck may not be able to provide at least six (6) months advance notice due to unplanned situations, including withoutlimitation, interruptions in Merck’s supply chain. In such situations, Merck shall provide as much advance notice as reasonably possible ofthe applicable Effective Change Date. If Merck provides less than six (6) months’ notice of a Material Change and such short notice inCustomer’s reasonable discretion will impact Customer’s supply needs, Customer shall have the right to adjust or cancel a Purchase Orderwithout penalty. Upon receipt of such notification, Oxford shall use commercially reasonable efforts to obtain regulatory market approval forsuch change (if such approval is necessary and Oxford decides, in its reasonable discretion, to continue utilizing the Products) prior to theEffective Change Date. Merck shall use (i) commercially reasonable efforts to support Oxford’s regulatory market approval efforts which mayinclude providing Oxford with necessary Product information and (ii) best efforts to supply Oxford with the Product, as manufactured priorto the Material Change, until the earlier of (a) such time as Oxford has validated or obtained regulatory market approval for the Productwhich includes the Material Change or (b) Merck is no longer able to produce the Product prior to the Material Change. Any such Productinformation shall be considered “Confidential Information” hereunder. 4.8.Inspection and Testing. Merck shall inspect and test all Products prior to shipment to Oxford in accordance with Merck’s standard qualitycontrol procedures. Merck shall provide a certificate of quality/analysis upon Oxford’s written request in the form attached hereto as ExhibitB. -6- 4.9.Right to Audit. Merck shall, upon receiving reasonable prior notice from Oxford, during normal business hours on a mutually agreed upondate and time, permit one (1) or more individual(s) from Oxford, regulatory agencies and/or notified bodies to conduct inspections andaudits of Merck’s facilities that produce the Products, provided that Oxford’s representatives comply with Merck’s visitation policiesprovided to Customer in advance and the provisions regarding Confidentiality set forth in Section 6 herein. 4.10.Labelling. Special packaging and labeling requests may result in extra charges. 5.SHIPPING AND DELIVERY 5.1.Shipping. All shipments of Product will be made FCA (Merck’s distribution center) Incoterms® 2010. Title will pass to Customer when theProduct leaves Merck’s point of distribution. Shipments will be made by standard shipping delivery service, with the cost of freight paid byMerck and included in the Price. 5.2.Delivery. If Merck is unable to meet the delivery dates set forth in a confirmed Purchase Order, Merck shall promptly notify Customer of thedelay after it is made known to Merck. If in Customer’s reasonable discretion such delay will impact Customer’s supply needs, Customershall have the right to adjust or cancel a Purchase Order without penalty upon receipt of Merck’s prior written consent, which shall not beunreasonably withheld. 6.CONFIDENTIALITY 6.1.Definition. “Confidential Information” means any confidential scientific, technical, financial or business information of a Party (“Discloser”)in whatever form (written, oral or visual) which is treated by such Party as confidential and is provided to the other Party under thisAgreement (“Recipient”). Confidential Information of Merck includes, but is not limited to, Specifications, Prices, formulae, processes,records, techniques, know-how and other proprietary information. 6.2.Obligations. Recipient agrees (a) to keep confidential the Confidential Information of Discloser and the terms of this Agreement, (b) not todisclose Discloser’s Confidential Information to any Third Party without the prior written consent of Discloser, and (c) to use suchConfidential Information only as necessary to fulfill its obligations or in the reasonable exercise of rights granted to it under this Agreement.Recipient may, however, disclose Confidential Information of Discloser to its employees and consultants in each case who have a specificneed to know such Confidential Information and who are bound by a like obligation of confidentiality and restriction on use, or to prosecuteor defend litigation. Further, either Party may disclose Confidential Information to the employees and consultants of such Party’s Affiliateswho have a specific need to know such Confidential Information in order to assist Party in carrying out its rights or obligations under thisAgreement and who are bound by a like obligation of confidentiality and restriction on use. Notwithstanding the foregoing, Oxford shall beentitled to disclose this Agreement to the extent required by applicable law or regulation, including, but not limited to, the public disclosureobligations of Oxford’s ultimate parent company, Oxford Immunotec Global PLC, due to its status as a publicly traded company. Prior to anypublic disclosure of this Agreement in satisfaction of applicable securities or other applicable laws, Oxford shall use commerciallyreasonable efforts to obtain and maintain confidential treatment of those portions of the Agreement that contain commercially sensitiveinformation, including but not limited to pricing and discounts. -7- 6.3.Exceptions. Recipient’s obligations of non-disclosure and non-use under this Agreement will not apply to any portion of Discloser’sConfidential Information that Recipient can demonstrate, by competent proof: (a)is generally known to the public at the time of disclosure or becomes generally known through no wrongful act on the part ofRecipient; (b)is in Recipient's possession at the time of disclosure other than as a result of Recipient's breach of any legal obligation; (c)becomes known to Recipient on a non-confidential basis through disclosure by sources other than Discloser having the legal right todisclose such Confidential Information; or (d)is independently developed by Recipient without reference to or reliance upon Discloser’s Confidential Information. If Recipient is required by a governmental authority or by order of a court of competent jurisdiction to disclose any ConfidentialInformation, Recipient will give Discloser prompt written notice of such requirement or order and Recipient will take all reasonable andlawful actions to avoid or minimize the degree of such disclosure. Recipient will cooperate reasonably with Discloser in any efforts to seek aprotective order. 6.4.Return. Recipient will, upon written request from Discloser, return or destroy all copies of materials containing Discloser’s ConfidentialInformation upon termination of this Agreement for any reason whatsoever; provided, however, that Recipient may retain, for its records, oneconfidential copy of such information for purposes of evidencing and monitoring its ongoing compliance with this Agreement and any suchcopies contained in Recipient’s backup IT systems until the ordinary course deletion thereof. -8- 6.5.Survival of Obligations. The Parties’ obligations under this Section 6 will survive for a period of five (5) years after the expiration,cancellation or termination of this Agreement. 7.INDEMNIFICATION AND INSURANCE 7.1.Customer Indemnity. Customer shall indemnify, defend and hold harmless Merck, its Affiliates and its and their directors, officers andemployees (each a “Merck Indemnified Party”) from against all claims, actions, liabilities, losses, demands, damages, fines, penalties, costsand expenses (including without limitation reasonable attorneys’ fees) (collectively, “Losses”), arising from any Third Party claim to whichany Merck Indemnified Party is or may become subject to the extent arising arise out of or are alleged or claimed to arise out of or inconnection with: (a)any breach by Customer of any of its obligations, representations or warranties under this Agreement; (b)any negligent act or omission or willful misconduct by Customer, its Affiliates or its or their directors, officers, employees, agents orsubcontractors; (c)any instruction, direction, protocol, method of manufacturing Product or Specification given by Customer or any of its Affiliates (orits or their officers, directors, employees, agents or subcontractors) to Merck or its Affiliates, which is materially followed, compliedwith, adopted, implemented and/or performed by Merck or its Affiliates; (d)the incorporation, conversion or formulation of a Product into a finished product (“Finished Product”) by Customer, its Affiliates or itsor their respective subcontractors or licensees; (e)the labeling, marketing, distribution, offer for sale or sale of a Product or Finished Product by Customer, its Affiliates or its or theirrespective distributors or licensees; (f)the use and/or consumption of a Product or Finished Product; (g)the infringement by the use of a Product and/or Finished Product of any intellectual property or other proprietary rights of any ThirdParty; or (h)any violation of any applicable law or regulation by Customer, its Affiliates or its or their directors, officers, employees, agents orsubcontractors; provided, however, that Customer shall have no obligation to indemnify, defend or hold harmless the Merck Indemnified Parties for anyLosses to the extent that such Losses were caused by the negligence or willful misconduct of any Merck Indemnified Party. -9- 7.2.Merck Indemnity. Merck shall indemnify, defend and hold harmless Merck, its Affiliates and its and their directors, officers and employees(each a “Customer Indemnified Party”) from against all Losses arising from any Third Party claim to which any Customer Indemnified Partyis or may become subject insofar as they are based upon, arise out of or are alleged or claimed to arise out of or in connection with: (a)any breach by Merck of any of its obligations, representations or warranties under this Agreement; (b)any negligent act or omission or willful misconduct by Merck, its Affiliates or its or their directors, officers, employees, agents orsubcontractors; (c)the infringement by the production or sale of a Product of any intellectual property or other proprietary rights of any Third Party; or (d)any violation of any applicable law or regulation by Merck, its Affiliates or its or their directors, officers, employees, agents orsubcontractors; provided, however, that Merck shall have no obligation to indemnify, defend or hold harmless the Customer Indemnified Parties for anyLosses to the extent that such Losses were caused by the negligence or willful misconduct of any Customer Indemnified Party. 7.3.Indemnification Procedures. The Party being indemnified (the “Indemnified Party”) will promptly notify the other Party (the “IndemnifyingParty”) in writing within thirty (30) days after learning of any claim for which the Indemnified Party wishes to seek indemnification pursuantto Section 7.1 or Section 7.2 as the case may be. The Indemnifying Party will have the right, but not the obligation, to assume the defense ofsuch liability with counsel satisfactory to the Indemnifying Party. If the Indemnifying Party assumes such defense, the Indemnifying Partywill have the sole right to control the defense and/or settlement or other disposition of any liability, and the indemnification provisions ofSection 7.1 or Section 7.2 as the case may be will not apply to amounts paid in connection with any liability if such payments are madewithout the consent of the Indemnifying Party; provided, that, that the Indemnified Party will have the right to retain its own counsel at itsown expense but the Indemnifying Party will have final decision-making authority regarding all matters relating to such defense. The failureby the Indemnified Party to deliver notice to the Indemnifying Party in accordance with the first sentence of this Section 7.3, will relieve theIndemnifying Party of liability to the Indemnified Party under Section 7.1 or Section 7.2 as the case may be, only to the extent such delayprejudiced the ability of the Indemnifying Party to conduct such defense. At the Indemnifying Party’s request, the Indemnified Party and itsdirectors, officers, employees and contractors will cooperate reasonably with the Indemnifying Party and its legal representatives, at theIndemnifying Party’s expense, in the investigation of any liability covered by the indemnification provisions in Section 7.1 or Section 7.2 asthe case may be and will provide full information with respect to such liability. -10- 7.4.Customer Insurance. Without limiting its liability under this Agreement, during the Term of this Agreement, Customer shall obtain andmaintain commercial general liability and product liability insurance with limits of not less than [***] Dollars ($[***]) per occurrence forgeneral liability and product liability. Customer, promptly upon Merck’s request, shall furnish Merck with certificates of insuranceevidencing such insurance coverage. 7.5.Merck Insurance. Merck shall maintain adequate commercial general liability and product liability insurance in such amounts and with suchscope of coverage as is customary in the life sciences industry with regard to the manufacture and sale of the Products. Merck, promptly uponCustomer’s request, shall furnish Customer with certificates of insurance evidencing such insurance coverage. 8.REPRESENTATIONS AND WARRANTIES 8.1.Product Warranty. (A)Product Warranty. Merck warrants that each Product furnished under this Agreement will conform to its Specifications for theWarranty Period (the “Product Warranty”). All Product Warranty claims must be filed in writing with Merck within the applicableWarranty Period. The duration of Merck’s Product Warranty is individual Product-specific for each Product furnished under thisAgreement (the “Warranty Period”). The Warranty Period begins on the date of shipment of the Product by Merck and expires on theearliest of: (i) one (1) year from the date of shipment; or (ii) any retest date, expiration date or shelf life date printed on the Productlabel, packaging or certificate of analysis. (B)Conditions. The validity of Merck’s Product Warranty is subject to the following conditions: the Product must be installed, used,handled, maintained, stored and shipped (as applicable) in accordance with (i) all use restrictions, label licenses, instructions,recommendations and warnings that are set forth in this Agreement, in any other related agreement or document, on any Product labelor packaging, or in Product literature furnished to Customer and (ii) all applicable laws and regulations. -11- (C)Exclusions. The Product Warranty will not apply and Merck will have no liability under any representation or warranty with respectto: (i) any failure to comply with the conditions set forth in Section 8.1(B) above, (ii) any contamination of, or damage to, the Productafter delivery of the Product by Merck; (iii) any modification, repair or enhancement of the Product by Customer or any Third Partywithout Merck’s prior written consent; and (iv) any Product for which payment has not been made in full to Merck. (D)Remedy. In the event of a valid and timely claim for breach of Product Warranty pursuant to Section 8.1(A) above, Merck’s soleobligation and Customer’s exclusive remedy will be for Merck, at its sole expense and option, to repair, rework or replace theapplicable Product or part thereof, at no charge to Customer. If after exercising commercially reasonable efforts, Merck is unable torepair, rework or replace the Product or part, then Merck will credit to Customer all monies paid to Merck for such applicable Productor part. This section shall not be construed to limit Merck’s obligations pursuant to this Agreement (or any breach thereof), includingMerck’s duty to indemnify Oxford. (E)Warranty Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANYREPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EITHER EXPRESS OR IMPLIED, WRITTEN OR ORAL,INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR APARTICULAR PURPOSE, OR WARRANTY OF NON-INFRINGEMENT, WHETHER ARISING BY LAW, COURSE OF DEALING,COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED. Customeris solely responsible for determining the suitability of the use of any Product in its production processes. 8.2.Compliance with Laws. Merck represents and warrants that the Products comply with all applicable federal, state and local laws andregulations and that Merck has obtained all necessary permits, licenses and certifications for providing Products hereunder. 8.3.Intellectual Property. Merck represents and warrants that the production and sale of the Products do not infringe any patent, copyright,trademark or other proprietary rights of any Third Party except to the extent the claim of infringement arises from the modification ornegligent use of the Products by Oxford. -12- 8.4.No Debarment. Merck represents and warrants that neither it nor, to its knowledge, any of its employees involved in manufacturing theProducts as of the Effective Date (i) is currently excluded, debarred or otherwise ineligible to participate in US federal health care programsas defined in 42 U.S.C. § I 320a-7b(t) (the “Federal healthcare programs”); or (ii) to its knowledge has been convicted of a criminal offenserelated to the provision of healthcare items or services that could result in being excluded, debarred or otherwise declared ineligible toparticipate in the Federal healthcare programs; or (iii) to its knowledge, is under investigation or otherwise aware of any circumstances whichmay reasonably result in Merck being excluded from participation in the Federal healthcare programs. 8.5.Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR IN ANY PURCHASE ORDER (OR IN ANYRELATED AGREEMENT OR DOCUMENT) TO THE CONTRARY, NEITHER PARTY SHALL BE LIABLE UNDER ANY LEGALTHEORY (WHETHER TORT, CONTRACT OR OTHERWISE) FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR ANYOTHER INDIRECT DAMAGE OR LOSS (INCLUDING, WITHOUT LIMITATION, LOST PROFITS) SUSTAINED BY THE OTHER PARTYOR ANY OTHER PERSON OR ENTITY ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE UNDERLYING PRODUCTS,REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. FOR PURPOSES OF THIS WAIVER, ANY LIABILITY INCURRED BY EITHERPARTY AS A RESULT OF ANY THIRD-PARTY CLAIM IS NOT CONSIDERED AN INDIRECT DAMAGE. NOTWITHSTANDINGANYTHING IN THIS AGREEMENT OR IN ANY PURCHASE ORDER (OR IN ANY RELATED AGREEMENT OR DOCUMENT) TO THECONTRARY, UNDER NO CIRCUMSTANCES SHALL MERCK’S AGGREGATE LIABILITY FOR ALL CLAIMS ARISING OUT OF ORRELATED TO A PRODUCT PURCHASED UNDER THIS AGREEMENT EXCEED THE AMOUNT ACTUALLY RECEIVED BY MERCKFROM CUSTOMER FOR SUCH PRODUCT. ALL CLAIMS MUST BE BROUGHT WITHIN ONE (1) YEAR OF SHIPMENT OF THEAPPLICABLE PRODUCT, REGARDLESS OF THEIR NATURE. IN NO EVENT SHALL MERCK BE LIABLE FOR ANY LOSS ORDAMAGE TO CUSTOMER’S IN-PROCESS COMMERCIAL PRODUCTS. 8.6.Compliance with Medical Device Legal Requirements. Customer acknowledges that the Products have not been tested by Merck for safetyand efficacy in food, drug, medical device, cosmetic, commercial or any other use, unless otherwise explicitly stated in Product data orProduct documentation provided by Merck. Customer will properly test, use, manufacture and market all Products purchased from Merckand/or materials produced with Products purchased from Merck in compliance with all applicable laws and regulations and obtain anynecessary intellectual property permission for its use of the Product. Oxford shall comply with all laws and regulations of any nationregulating the marketing and sale of medical devices, applicable to Oxford’s use and sale of the Products, and agrees to assume fullresponsibility for the conduct of all Products recalls. Merck shall provide reasonable cooperation to Oxford’s regulatory compliance effortswith respect to the Products. -13- 9.TERM AND TERMINATION 9.1.Term. This Agreement will be effective commencing on the Effective Date and will, unless terminated in accordance with section 9.2,continue in full force and effect for a period of five (5) years from the Effective Date (the “Term”). 9.2.Termination. Either Party may terminate this Agreement at any time upon at least twelve (12) months’ written notice to the other Party(“Termination for Convenience”). In the event of a Termination for Convenience by Merck, Merck shall provide Customer with theopportunity to continue to purchase Product under the terms and conditions of this Agreement for up to twelve (12) months after the actualtermination date, but in no event shall Customer be permitted to purchase Product under the terms of this Agreement after the Term. If eitherParty breaches any material agreement, condition or covenant of this Agreement, and (i) such breach is not remedied within thirty (30) daysafter receipt by the breaching Party of a notice thereof from the non-breaching Party, or (ii) for any breach other than a payment breach byCustomer, steps to remedy such breach have not been initiated to the non-breaching Party’s reasonable satisfaction within thirty (30) daysafter receipt by the breaching Party of a notice thereof from the non-breaching Party, the non-breaching Party may terminate this Agreementby written notice to the breaching Party. 9.3.Effect of Termination. Expiration or termination of this Agreement will not affect the liability of either Party for claims or obligations thatarose prior to the effective date of such expiration or termination. Without limiting the generality of the foregoing, upon expiration ortermination of this Agreement for any reason, unless the Parties mutually agree otherwise or Merck elects to cancel such Purchase Orders inaccordance with this Section 9.3, Customer will remain liable to purchase, and Merck will remain liable to sell and deliver, all Productscovered by outstanding Purchase Orders that were accepted by Merck prior to the effective date of expiration or termination. If terminationoccurs as the result of Customer’s material breach of this Agreement, Merck may, in its sole discretion, elect to terminate any outstandingPurchase Orders that were accepted by Merck prior to the effective date of termination by providing notice to Customer of such cancellationalong with Merck’s notice of termination for such breach. The provisions of Sections 3.1, 3.2, 3.3, 4.2(c), 4.3, 5, 6, 7, 8, 9.3, 10 and 11 willsurvive any expiration or termination of this Agreement. -14- 10.EXPORT COMPLIANCE Compliance with Laws. Customer will comply with all applicable restrictions imposed by the United States of America and all other relevant countries orjurisdictions upon the export of the Products pursuant to the Export Administration Act of 1979, 93 Statutes at Large, Section 503, et. seq., as from time totime amended, or any successor act and all regulations promulgated thereunder and all laws and regulations covering the same subject matter in all otherrelevant countries or jurisdictions. 11.MISCELLANEOUS 11.1.Independent Contractors. The Parties are and will remain independent contractors and nothing contained in this Agreement will beconstrued to place the Parties in the relationship of employer and employee, partners, principal and agent, or joint ventures. Neither Partywill have the power to bind or obligate the other Party nor will either Party hold itself out as having such authority. 11.2.Publicity. Neither Party will make commitments nor disbursements, incur obligations or place any advertising, public relations orpromotional material for the other Party and/or its Affiliates. Neither Party will disseminate any material of any kind using the name of suchother Party and/or its affiliates or using their trademarks, without the prior written approval of an authorized representative of such otherParty. 11.3.Notices. Except as set forth in Section 4.2, any notice required or permitted to be given under this Agreement will be in writing, willspecifically refer to this Agreement and will be deemed to have been sufficiently given for all purposes upon receipt if delivered (a) by firstclass certified or registered mail, postage prepaid, (b) express courier delivery service or (c) personally. Unless otherwise specified in writing,the notice addresses of the Parties will be as described below. If to Merck:Millipore (U.K.) Ltd. Attn: Applied Sales Suite 21, Building 6, Croxley Green Business Park Watford Hertfordshire WD18 8YH UK -15- With a copy to:EMD Millipore Corporation Attn: Legal Department 400 Summit Drive Burlington, MA 01803 USA If to Customer:Oxford Immunotec Ltd. Attn: Chief Executive Officer 94C Innovation Drive, Milton Park Abingdon Oxfordshire, OX14 4RZ UK 11.4.Governing Law. This Agreement will in all events and for all purposes be governed by, and construed in accordance with, the laws of theCommonwealth of Massachusetts without regard to any choice of law principle that would dictate the application of the law of anotherjurisdiction. The Parties agree that the provisions of the 1980 United Nations Convention on Contracts for the International Sale of Goodsand the 1974 Convention on the Limitation Period in the International Sale of Goods, as amended by that certain Protocol adopted inVienna on April 11, 1980, will not apply to this Agreement, and are hereby expressly excluded. The Parties consent to the exclusivejurisdiction of the state and federal courts located in Boston, Massachusetts for the enforcement of the terms of this Agreement and the entryof judgment on any award rendered under this Agreement. 11.5.Severability. Each provision in this Agreement is independent and severable from the others, and no provision will be renderedunenforceable because any other provision may be invalid or unenforceable in whole or in part. If the scope of any restrictive provision inthis Agreement is too broad to permit enforcement to its full extent, then such restriction will be reformed to the maximum extent permittedby law. 11.6.Force Majeure. Each Party will be excused from default or delay in the performance of its obligations hereunder (other than the obligation tomake payments of money) if and to the extent that such default or delay is caused by an act of nature (e.g., flood, earthquake or storm), act ofwar, insurrection, civil commotion, riot, destruction of facilities or materials, fire, explosion, labor disturbance or strike, the laws orregulations of any government, regulatory or judicial authority, embargo, shortage of raw materials, equipment failure, failure of publicutilities or common carriers, and any other causes beyond the reasonable control of the applicable Party (each, a “Force Majeure Event”).The Party affected by a Force Majeure Event (or Merck in the case of any Force Majeure Event affecting any relevant Merck Affiliate orsubcontractor) will promptly notify the other Party, explaining the nature, details and expected duration thereof. Such Party will also notifythe other Party from time to time as to when the affected Party (or relevant Merck Affiliate or subcontractor as the case may be) reasonablyexpects to resume performance in whole or in part of its obligations under this Agreement, and to notify the other Party of the cessation ofany such event. A Party affected by a Force Majeure Event will use commercially reasonable efforts to remedy, remove, or mitigate suchevent and the effects thereof with all reasonable dispatch. Upon termination of the Force Majeure Event, the performance of any suspendedobligation or duty will promptly recommence. If the Force Majeure Event persists for more than six (6) months, Merck may terminate thisAgreement by written notice to Customer. -16- 11.7.Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent ofthe other Party, except either Party may make such an assignment or transfer without the other Party’s consent (a) to an Affiliate of a Party, or(b) to the successor to all or substantially all of the business or assets of a Party to which this Agreement relates (whether by merger, sale ofstock, sale of assets or other transaction). Any permitted successor or assignee of rights and/or obligations hereunder will, in a writing to theother Party, expressly assume performance of such rights and/or obligations. Any assignment or attempted assignment by either Party inviolation of the terms of this Section 11.7 will be null and void. 11.8.Waiver. The failure of either Party to take action as a result of a breach of this Agreement by the other Party will constitute neither a waiver ofthe particular breach involved nor a waiver of either Party’s right to enforce any or all provisions of this Agreement through any remedygranted by law or this Agreement. 11.9.Entire Understanding. This Agreement, including all Exhibits, which are incorporated into this Agreement by this reference, contains theentire understanding of the Parties with respect to its subject matter, supersedes any prior or contemporaneous written or oralcommunications, statements or agreements between the Parties relating to such subject matter, and may only be modified or altered inwriting signed by authorized representatives of both Parties. 11.10.Titles and Headings. The titles and headings of each section and paragraph of this Agreement are for reference only and will not affect theconstruction or interpretation of any provision of this Agreement. 11.11.Third Party Beneficiaries. This Agreement is for the benefit of the Parties hereto and not for any other person except as may be specificallyagreed to in writing by the Parties. -17- 11.12.Counterparts. This Agreement may be executed in any number of counterparts, each of which will be an original and all of which togetherwill constitute one and the same document binding on all Parties hereto. 11.13.Electronic Signatures. The Parties agree that electronic signatures (including but not limited to Docusign® or a comparable format) of thisAgreement are intended to authenticate this Agreement and shall have the same force and effect as manual signatures. [The remainder of this page is left blank intentionally.] -18- IN WITNESS WHEREOF, the Parties hereto, each by a duly authorized officer, have entered into this Agreement as of the date first set forth above. OXFORD IMMUNOTEC LIMITEDMILLIPORE (U.K.) LTD. By:/s/: A.P. Gaskell By:/s/: Victor Mark Jackson /s/: Peter Biro Name:Peter Gaskell Name:Victor Mark Jackson P. Biro Title:VP, Operations Title:Director Director Date:07 Jan 2019 Date:21st Dec 2018 21/21/18 -19- THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXHIBIT A [***]  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXHIBIT B [***] Exhibit 10.13 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. AMENDED AND RESTATED SUPPLY AND RESELLER AGREEMENT This Amended and Restated Supply and Reseller Agreement (the "AGREEMENT") is by and between LIFE TECHNOLOGIES CORPORATION ("LTC"), aDelaware corporation, with a principal business address at 29851 Willow Creek Road, Eugene, Oregon 97402 and Oxford Immunotec, Ltd. ("OI"), acompany incorporated under the laws of England and Wales, with a principal business address at 94C Innovation Drive, Milton Park, Abingdon,Oxfordshire, OX14 4RZ, U.K., and is effective as of January 1, 2019 (the "EFFECTIVE DATE"). ARTICLE 1. BACKGROUND RECITALS1.1LTC is experienced in the manufacture and supply of AIM V® Media. 1.2OI is experienced in the development and marketing of in vitro diagnostic tests for the diagnosis of tuberculosis and other diseases. 1.3LTC and OI (each a "Party", jointly the "Parties") previously entered into a Supply and Reseller Agreement, effective August 12, 2013, asamended on March 1, 2014, July 26, 2016, and February 16, 2017 (collectively, the “Original Agreement”), pursuant to which LTC provided OIwith certain materials that are AIM V® media products for resale and for use with OI in vitro diagnostic tests for the diagnosis of tuberculosis andother diseases under the terms and conditions set forth in the Original Agreement. 1.4LTC and OI now wish to amend and restate the Original Agreement in its entirety under the terms and conditions set forth hereunder. 1.5Capitalized words and phrases are defined, for purposes of this AGREEMENT, where they first appear or as set forth in Article 2. 1.6LTC and OI, in consideration of the premises and of the mutual covenants and agreements contained herein and for other good and valuableconsideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree to the terms andconditions herein. OI.LTC.Supply AgreementPage 1 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 2. DEFINITIONSFor purposes of this AGREEMENT, the following definitions shall apply: 2.1"AFFILIATE" means with respect to a referenced entity, any entity that CONTROLS, is CONTROLLED by, or is under common CONTROL withthe referenced entity, but only so long as such CONTROL exists. 2.2"AUTHORIZED LTC AFFILIATES" means LTC, or an AFFILIATE of LTC that is specifically authorized to supply LTC PRODUCTS to OI or OIAFFILIATES under this AGREEMENT. The AUTHORIZED LTC AFFILIATES under this AGREEMENT as of the EFFECTIVE DATE are listedin Exhibit A (AUTHORIZED LTC AFFILIATES), which may be unilaterally updated by LTC in accordance with paragraph 4.1. 2.3"CONFIDENTIAL INFORMATION" of a Party shall have the meaning set forth in the Confidentiality Agreement dated August 12, 2013, a copyof which is attached hereto as Exhibit C. 2.4"CONTROL" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of an entity,whether through the ownership of voting securities, voting power, or similar interests in said entity. 2.5"DISTRIBUTOR" means a THIRD PARTY that has a written agreement with OI pursuant to which the THIRD PARTY is authorized to promote,market and sell OI PRODUCTS in a particular geographic area to END-USERS. 2.6"EFFECTIVE DATE" is defined in the preamble of the AGREEMENT. 2.7“ELISPOT assay” means Enzyme-Linked Immunosorbent SPOT assay. 2.8"END-USER" means the ultimate purchaser of an OI PRODUCT, whose use consumes or destroys the commercial utility of such OI PRODUCT, orafter which use any remaining OI PRODUCT is discarded. OI.LTC.Supply AgreementPage 2 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 2.9"FIELD OF USE" means use related to the performance of ELISPOT assays for human in vitro diagnostic applications. 2.10"LTC TRADEMARK RIGHTS" means the trademarks listed in Exhibit B (LTC PROPRIETARY RIGHTS), whether or not such trademarks areregistered with the US Patent and Trademark Office or other governmental body. 2.11"LTC PRODUCT" means AIM V® media products supplied to OI or its AFFILIATES by the AUTHORIZED LTC AFFILIATE under the terms ofthis AGREEMENT, which media products are identified in Exhibit A, which Exhibit may be modified from time to time by written agreement ofthe Parties. 2.12“OI PRODUCT” means (i) a product made, sold or otherwise or commercialized by or on behalf of OI relating to ELISPOT assays, in each casethat includes an LTC PRODUCT as a component, or (ii) an LTC PRODUCT sold or distributed by OI or AFFILIATES as a stand-alone productintended for use with ELISPOT assays that are sold or distributed by OI or AFFILIATES. 2.13“OI TESTING SERVICE" means use of LTC PRODUCT(S) or OI PRODUCT(S) to perform an ELISPOT test for fee consideration by or on behalfof OI. 2.14"THIRD PARTY" means a person or entity that is not OI or LTC and is not an AFFILIATE of OI or LTC. 2.15"UNIT", with respect to each LTC PRODUCT, has the meaning set forth in Exhibit A. 2.16"US" means the United States of America. 2.17"YEAR" means calendar year. OI.LTC.Supply AgreementPage 3 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 3. SCOPE OF AGREEMENT3.1This AGREEMENT sets forth the terms and conditions that govern LTC’s supply of the LTC PRODUCTS, as set forth in Exhibit A (LTCPRODUCTS) to OI and its AFFILIATES. This AGREEMENT does not apply to the purchase or supply of any other materials or services, and,except as provided herein, does not apply to the grant of any intellectual property rights of LTC or its AFFILIATES. 3.2Subject to all of the terms and conditions of this AGREEMENT, LTC agrees to supply, or have another AUTHORIZED LTC AFFILIATE supplyOI and its AFFILIATES with LTC PRODUCTS for (a) OI's or its AFFILIATES’ use in the manufacturing of OI PRODUCTS, (b) use in OI TESTINGSERVICES for the FIELD OF USE, (c) sale by OI or its AFFILIATES as a component of OI PRODUCTS, or as a stand-alone product for use inconjunction with OI PRODUCTS, in each case that are sold or offered for sale in the FIELD OF USE, and (d) research and development relating toOI PRODUCTS and OI TESTING SERVICES. Subject to all of the terms of this AGREEMENT, LTC hereby grants to OI, and OI hereby acceptsfrom LTC, a non-exclusive license under LTC TRADEMARK RIGHTS throughout the world, without right to sublicense (except to the extentthat the exercise of OI’s rights by its AFFILIATES or by DISTRIBUTORS as expressly granted in 3.3 below is deemed a sublicense), for OI and itsAFFILIATES to use the LTC TRADEMARK RIGHTS to import, export, offer to sell, and sell OI PRODUCTS and OI TESTING SERVICES, as setforth in subparagraphs 3.2(b) and 3.2(c) above. 3.3LTC and OI agree that OI or its AFFILIATES may sell LTC PRODUCTS in conjunction with, or as a component of, OI PRODUCTS as referencedin Section 3.2(c) above, through DISTRIBUTORS, provided that such DISTRIBUTORS sell such OI PRODUCTS only for use in the FIELD OFUSE and in the same packaging as received from OI or its AFFILIATES. 3.4LTC reserves all rights (i) for its AFFILIATES to sell any LTC PRODUCT or (ii) to license or transfer technology used to prepare any LTCPRODUCT to any other party or parties as it may, in its sole discretion, deem advisable, or not at all; provided, however, any such license ortransfer under subsection (ii) shall not affect or otherwise impair OI’s rights under this Agreement. 3.5OI acknowledges that there may be proprietary rights owned by THIRD PARTIES that may be necessary for the commercialization of OIPRODUCTS or performance of OI SERVICES, and OI agrees that i) securing access to such THIRD PARTY rights is the responsibility of OI, andii) neither LTC nor any AFFILIATE of LTC has any responsibility or liability with respect to any such THIRD PARTY proprietary rights. ThisAGREEMENT confers no license or rights by implication, estoppel or otherwise under any existing or future intellectual property rights ownedby or licensed to LTC or its AFFILIATES other than those LTC TRADEMARK RIGHTS expressly set forth herein, if any, regardless of whethersuch intellectual property rights are relevant to or useful for OI’s use of LTC PRODUCTS, including use in commercialization of OI PRODUCTSor OI SERVICES, as provided herein. 3.6To the extent that the rights granted to OI are shared with one or more of its AFFILIATES pursuant to paragraph 3.2 (supply rights) hereunder, OIshall require that such AFFILIATES are bound by the limitations and obligations imposed on OI hereunder.. ARTICLE 4. SUPPLY TERMS4.1LTC PRODUCTS will be supplied to OI by the AUTHORIZED LTC AFFILIATE as identified in Exhibit A (AUTHORIZED LTC AFFILIATES),according to the location in which such LTC PRODUCTS will be supplied. LTC shall have the option to designate one or more differentAUTHORIZED LTC AFFILIATES, of which OI will be notified in accordance with paragraph 17.1 (notice requirements). Each AUTHORIZEDLTC AFFILIATE hereunder shall be required to follow the procedures and requirements set forth herein with respect to the supply of LTCPRODUCTS; and OI’s obligations hereunder with respect to purchases and orders of LTC PRODUCTS shall be due likewise in equal measure toeach such AUTHORIZED LTC AFFILIATE. 4.2LTC PRODUCTS that are the subject of this Agreement are as set forth on Exhibit A, which may be amended from time to time upon agreementof the Parties. Pricing for the LTC PRODUCTS is set forth in Exhibit A (pricing of LTC PRODUCTS). OI.LTC.Supply AgreementPage 4 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 4.3The minimum number of UNITS that OI must purchase per YEAR (Minimum Annual Purchase) and minimum number of UNITS that OI mustorder for a single shipment to a specified location (Minimum Shipment/Minimum Order) are set forth in Exhibit A (pricing of LTC PRODUCTS).To the extent that OI's combined purchases of LTC PRODUCTS from the respective AUTHORIZED LTC AFFILIATE in any YEAR are less thanthe Minimum Annual Purchase for that YEAR, OI shall pay the shortfall to the respective AUTHORIZED LTC AFFILIATE, no later than thirty(30) days following the end of the YEAR in which the Minimum Annual Purchase requirement was not met. 4.4OI shall submit a 12 month written forecast to LTC on the Effective Date, specifying the estimated quantity of LTC Products which OI willrequire for each calendar quarter for the next YEAR. OI shall submit revised forecasts 4 times per YEAR, at least one (1) month beforecommencement of each calendar quarter. The volume of LTC Products specified by OI for the first calendar quarter of each 12 month forecast willbe a firm order, which will be invoiced by LTC not later than 30 days after the end of the relevant calendar quarter. 4.5OI acknowledges that LTC PRODUCTS that are commercialized by LTC and its AFFILIATES primarily as research reagents may not be on theUS Toxic Substances Control Act (TSCA) inventory and are exempt from Pre-Manufacture Notification (PMN) requirements under TSCA, orsimilar regulations or government controls in other jurisdictions. Nothing in this paragraph shall require LTC or its AFFILIATES to make anyregulatory filings or supply any regulatory agency with any documentation other than those required in order for OI or its AFFILIATES to supplyLTC PRODUCTS as research reagents. OI shall be solely responsible for obtaining all applicable regulatory authorizations, consents andlicenses, including pre-market approvals, and OI must comply and require its AFFILIATES and DISTRBUTORS to comply with all governmentalrequirements, including but not limited to, all applicable laws, statutes, regulations, and treaties, relating to the manufacture, pre-marketing andmarketing, sale, storage, shipment, and distribution of LTC PRODUCTS/OI PRODUCTS and/or OI SERVICES by or on behalf of OI, and relatingto the performance of OI’s duties and obligations under this AGREEMENT. LTC or its AFFILIATES shall provide directly to any applicableregulatory agencies any information or documentation which is reasonably requested in order for OI or its AFFILIATES to obtain and maintaincertifications or regulatory approvals for the labeling, marketing, sale or distribution of the LTC PRODUCTS as contemplated by thisAGREEMENT. 4.6OI shall not, and shall require that its AFFILIATES and DISTRIBUTORS not, (a) knowingly export, re-export, sell, or otherwise distribute,directly or indirectly, any LTC PRODUCTS (including LTC PRODUCTS incorporated in OI PRODUCTS) to a customer or nation to which LTCcould not directly obtain an export license to export, re-export, sell, or otherwise distribute the LTC PRODUCTS or OI PRODUCTS, in violationof US government regulations, including US Export Administration Regulations, found at Title 15, Part 730 et seq. of the US Code of FederalRegulations; or (b) take any action in furtherance of an unlawful order, promise, or payment to a non-US public official, in violation of the USForeign Corrupt Practices Act (FCPA), nor take any action that would cause LTC or its AFFILIATES to be in violation of the FCPA. Notwithstanding any other provision of this AGREEMENT, neither OI, LTC, nor any of the foregoing Parties' AFFILIATES shall be required totake or refrain from taking any action impermissible or penalized under the laws of the US or any applicable foreign jurisdiction, includingwithout limitation the anti-boycott laws administered by the US Commerce and Treasury Departments. 4.7LTC and each AUTHORIZED LTC AFFILIATE shall comply with all laws and regulatory requirements relating to the manufacture of the LTCPRODUCTS including, without limitation, good manufacturing practices, record keeping requirements and such other requirements that mayarise in accordance with ISO 13485 (“Quality System”). LTC shall ensure that each LTC PRODUCT has been manufactured in compliance withthe requirements of such Quality System, and LTC shall create and retain records relating to each batch of such LTC PRODUCTS in accordancewith the requirements of such Quality System. 4.8LTC and OI, and their respective AFFILIATES, shall comply with the quality provisions set out in Exhibit D. OI.LTC.Supply AgreementPage 5 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 5. ORDERING5.1OI shall place its orders to purchase LTC PRODUCTS in writing, according to the e- mail, fax, or mailing information specified by the respectiveAUTHORIZED LTC AFFILIATE. With each order, OI must provide i) contact name, address, and fax, e-mail, or telephone number, ii) shippingaddress, iii) billing address, iv) quantity of each LTC PRODUCT and corresponding product number applicable to this AGREEMENT and thedelivery schedule of such quantity (subject to paragraph 8.1), v) purchase order number, and (vi) appropriate customer account numbers. 5.2Each order to purchase LTC PRODUCTS is subject to acceptance by the respective AUTHORIZED LTC AFFILIATE, which acceptance may beaccomplished by shipment of the corresponding LTC PRODUCTS within the next business day or by confirmation of the expected shipmentdate, as set forth in Article 8 (shipping and delivery). 5.3Each accepted order shall be subject to the terms, conditions and provisions of this AGREEMENT and not to any other additional orcontradictory terms printed on a purchase order or acknowledgment form. 5.4After an order is accepted in accordance with paragraph 5.2, the respective AUTHORIZED LTC AFFILIATE may refuse any request for changesto such order or cancellation of such order at its sole discretion but shall make commercially reasonable efforts to accommodate the requestedchange or cancellation. 5.5Any duplicate order will be charged to OI unless the duplicate order is marked as "confirming." OI.LTC.Supply AgreementPage 6 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 6. LIMITATIONS6.1LTC PRODUCTS shall be manufactured and packaged to meet LTC’s standard specifications as set forth in Exhibit A (specifications), whichspecifications are subject to change solely upon advance written notice to OI. 6.2LTC shall prepare a Certificate of Analysis (C of A) and Material Safety Data Sheet (MSDS) for the LTC PRODUCTS and such documents shallbe included with shipments of ordered LTC PRODUCTS. OI shall be responsible for distribution of information contained in the MSDS to itsemployees and AFFILIATES, and if such information is legally required to accompany materials transferred by OI, to THIRD PARTIES. 6.3The specifications for the LTC PRODUCTS set forth in Exhibit A (specifications) of this AGREEMENT shall be used to determine conformanceto the specifications of the LTC PRODUCTS supplied hereunder for acceptance purposes. OI shall be solely responsible for testing anddetermining the suitability of LTC PRODUCTS for use in OI PRODUCTS, and any intended use or application thereof, and for communicatingthe appropriate cautionary information to subsequent purchasers and users of OI PRODUCTS. 6.4OI hereby acknowledges that the LTC Products are warranted for research use only and that the LTC Products have no Approvals for use indiagnostic or therapeutic procedures, or for any other use requiring compliance with any law or regulation regulating diagnostic or therapeuticproducts or any similar product (hereinafter collectively referred to as “regulatory laws”). OI further acknowledges that LTC Products have notbeen tested or validated for any particular use or purpose or for safety or effectiveness. It is OI’s responsibility to test, validate or take otheractions necessary for any specific use or applications and to ensure the LTC Products meet applicable regulatory, certification, validation orother requirements. The LTC Products may not be used for any purpose that would require Approvals unless proper Approvals are obtained. OIagrees that if it elects to use, or to permit any Third Party to use, the LTC Products for a purpose that would subject LTC or the LTC Products tothe jurisdiction of any regulatory laws, OI will be solely responsible for obtaining any required Approvals and otherwise ensuring that OI’s (orThird Parties to whom it provides the LTC Products) use of the LTC Products complies with such regulatory laws. OI shall defend and indemnifyLTC and its Affiliates against any claims, liabilities, losses, damages or expenses, including reasonable attorneys' fees and other costs ofdefending any action, which they may suffer as a result of any claim relating in any way to OI’s failure to obtain any necessary Approvals or tocomply with any regulatory laws. OI.LTC.Supply AgreementPage 7 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. For the purposes of this Article 6 “Approvals” means all necessary clearances, approvals, registrations or other qualifications or verificationsrequired from any regulatory agency to permit use in diagnostic or therapeutic procedures, or for any other use requiring compliance with anylaw or regulation regulating diagnostic products or any similar product. ARTICLE 7. PRICING FOR LTC PRODUCTS7.1The pricing for OI’s or its AFFILIATES’ purchases of LTC PRODUCTS under this Agreement is set forth in Exhibit A (pricing of LTCPRODUCTS). The pricing shown on Exhibit A is exclusive of value added tax. 7.2As noted in Exhibit A (pricing of LTC PRODUCTS), the initial purchase price may be subject to a standard price increase set forth therein, whichstandard price increase shall be separate from, and/or in addition to any price change resulting from a change in the specifications for such LTCPRODUCT that is requested by OI pursuant to paragraph 6.3 (modified specifications), and which standard price changes shall be effective forany shipment that occurs after the date of implementation thereof. ARTICLE 8. SHIPPING AND DELIVERY8.1Unless the respective AUTHORIZED LTC AFFILIATE and OI agree otherwise in writing, the expected shipment date for LTC PRODUCTS shallbe within sixty (60) days after acceptance of an order that is placed in accordance with Article 5 (ordering), where such order does not exceed thequantity covered by the binding element of OI’s then most recent forecast provided pursuant to paragraph 4.4 (forecasts); and within ninety (90)days after acceptance of the order, where such order is in excess of the amount forecast in the binding portion of the then most recent forecast orfor volumes of LTC PRODUCT not subject to the binding element of the forecast, either of which schedules may be modified if the specificationsare changed at the request of OI in accordance with paragraph 6.3. OI.LTC.Supply AgreementPage 8 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 8.2After acceptance of an order, and unless stated otherwise in the order, LTC PRODUCTS shall be shipped DAP OI facility (identified in Exhibit A)(Incoterms 2010) by the AUTHORIZED LTC AFFILIATE as determined with reference to Exhibit A to OI or the designated OI AFFILIATE;provided, however, that OI or the designated OI AFFILIATE shall pay for insurance in transit. 8.3The respective AUTHORIZED LTC AFFILIATE will be responsible for packaging and otherwise determining the appropriate method to preserveand protect the LTC PRODUCTS during normal and customary handling in transit and meeting its obligations and regulatory requirements. LTCreserves the right for each respective AUTHORIZED LTC AFFILIATE to make delivery in installments, each such installment to be separatelyinvoiced (including shipping charges), if necessary to meet the obligations of this paragraph. 8.4Any shipment of LTC PRODUCTS may be postponed or terminated, as required by law. 8.5Following shipment of the LTC PRODUCTS, the AUTHORIZED LTC AFFILIATE shall invoice OI for such LTC PRODUCTS according to thepricing as set forth in Article 7 (pricing). OI shall pay the respective AUTHORIZED LTC AFFILIATE for such LTC PRODUCTS, includingshipping charges according to paragraph 8.2, according to the manner of payment set forth in paragraph 11.1 (payment methods), within thirty(30) days after the date of the invoice. OI shall be responsible for all taxes, assessments, duties, and other governmental fees of any naturewhatsoever that are levied on LTC PRODUCTS upon shipment to OI. ARTICLE 9. INSPECTIONS AND RETURNS9.1Any return of LTC PRODUCTS requires written authorization from the respective AUTHORIZED LTC AFFILIATE, and a return authorizationnumber. Any claim for shipping discrepancies or damage must be made within ten (10) days after receipt of the shipment. LTC or theAUTHORIZED LTC AFFILIATE shall promptly respond to submitted claims and replace, reship, or issue a refund to OI, if applicable, dependingon the type and source of error. OI.LTC.Supply AgreementPage 9 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 9.2Provided that LTC or the AUTHORIZED LTC AFFILIATE provides the C of A and MSDS as provided in Section 6.2, within twenty (20) businessdays after OI receives a shipment of LTC PRODUCTS from the respective AUTHORIZED LTC AFFILIATE, OI shall notify the respectiveAUTHORIZED LTC AFFILIATE of any claim of a non-conforming LTC PRODUCT, but in any event prior to any use, modification orderivitization of the LTC PRODUCT other than for testing purposes by OI or its AFFILIATES to determine conformance of the LTC PRODUCTSto the specifications set forth in Exhibit A (Specifications). The absence of any such notice within such period shall constitute acceptance of theLTC PRODUCTS by OI. Within fifteen (15) business days after OI provides any such notice, LTC shall notify OI of the disposition of the claim. IfLTC confirms that an LTC PRODUCT was non-conforming when shipped, LTC or the AUTHORIZED LTC AFFILIATE shall make reasonableefforts to replace any non-conforming LTC PRODUCT within 30 days after such confirmation. If LTC determines that the LTC PRODUCTSsubject to the claim were in conformance with the applicable specifications when shipped, LTC or the AUTHORIZED LTC AFFILIATE and OIshall use their reasonable commercial efforts to establish the cause of the discrepancy, and to resolve the matter. OI shall arrange for the disposaland destruction of any non-conforming LTC PRODUCTS, or at LTC’s request and expense, OI shall return the non-conforming LTC PRODUCTSto LTC or the AUTHORIZED LTC AFFILIATE.. 9.3Neither LTC nor its AFFILIATES will be responsible for any non-conformance that is due to any failure by the carrier or OI to handle or storeLTC PRODUCTS as indicated on the label, specifications, or accompanying product information. ARTICLE 10. TRADEMARK USE10.1OI shall use the AIM V® trademark, according to format set forth in Exhibit A (LTC PRODUCTS), in product inserts, advertisements and salesliterature (including Web based literature), and on the product labels where space permits, to identify the LTC PRODUCTS in OI PRODUCTS,and shall acknowledge LTC's ownership of the trademark when so used; and the font size and style of such trademark and dye designation andacknowledgement shall be comparable to the font size and style of the text describing the LTC PRODUCTS or OI PRODUCTS in such productinserts, advertisements and sales literature. OI shall use only displays, labels, forms, and other paper or similar products imprinted with suchcolors and trademarks as are prescribed from time to time by LTC (including but not limited to size, design, and color of such trademarks). At therequest of LTC, OI shall provide a reasonable number of OI PRODUCTS sufficient to verify that product quality standards consistent with theAIM V® trademark have been met. OI.LTC.Supply AgreementPage 10 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 10.2All uses and goodwill associated with the LTC TRADEMARK RIGHTS will inure to the benefit of LTC. OI shall not register, nor attempt toregister, nor aid any AFFILIATE or THIRD PARTY in the foreign registration of any trademarks included in LTC TRADEMARK RIGHTS unlessLTC has given express written approval for such registration. No right or license is granted to use the trademarks included in LTC TRADEMARKRIGHTS in connection with any materials that do not contain LTC PRODUCTS. 10.3OI shall promptly notify LTC in writing of any THIRD PARTY claim made against OI, its AFFILIATES, or its DISTRIBUTORS that any LTCTRADEMARK RIGHTS used by OI, infringes any trademark or similar proprietary right of any party. LTC shall determine, in its sole discretion,an appropriate response to such claim. 10.4Prosecution of a THIRD PARTY for the infringing use of trademarks licensed hereunder may be undertaken by LTC at its option. OI shall provideinformation reasonably requested by LTC in connection with such matters. ARTICLE 11. PAYMENTS11.1LTC or the AUTHORIZED LTC AFFILIATE will invoice OI or its AFFILIATE for the LTC PRODUCTS ordered in accordance with the terms ofArticle 5 of this AGREEMENT. OI or its AFFILIATE shall remit payment on properly issued invoices within forty-five (45) days of the date of theinvoice. 11.2All amounts payable under this AGREEMENT to the AUTHORIZED LTC AFFILIATE shall be in the currency of the location in which theAUTHORIZED LTC AFFILIATE is located. OI.LTC.Supply AgreementPage 11 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 11.3Late charges not to exceed the maximum amount allowed by law in the jurisdiction of the affected shipment may be added to invoices not paidwithin the specified payment term. Where invoices for LTC PRODUCTS are not timely paid, subsequent shipments may be delayed or subject toprepayment until overdue amounts are paid. ARTICLE 12. CONFIDENTIALITY12.1Each Party agrees to maintain, and require its AFFILIATES and its and their employees to maintain, CONFIDENTIAL INFORMATION inaccordance with the Confidentiality Agreement attached hereto as Exhibit C. ARTICLE 13. WARRANTIES13.1Each Party represents and warrants to the other that (i) it is a company or corporation duly organized, validly existing and in good standing underthe laws of the jurisdiction in which it is organized; and (ii) this AGREEMENT constitutes the legal, valid and binding obligation of such Party,enforceable against such Party in accordance with its terms. 13.2OI acknowledges that the LTC PRODUCTS should be used with the same protective measures and degree of caution used with any chemicalcompound known to be potentially hazardous, and OI covenants that the use of LTC PRODUCTS by OI or its AFFILIATES shall be supervisedby a technically qualified individual. 13.3LTC covenants and warrants to OI that (a) the LTC PRODUCTS shall be in compliance with the Specifications; (b) the LTC PRODUCTS will bemanufactured in accordance with applicable law; (C) LTC will convey good and valid title to the LTC PRODUCTS to OI or its AFFILIATES, freefrom any lien, claim, security interest or encumbrance. These warranties shall survive delivery of and payment for the LTC PRODUCTS and shallrun to OI, its AFFFILIATES, successors, and assigns. LTC MAKES NO OTHER REPRESENTATION OR WARRANTY OF ANY KIND,EXPRESS OR IMPLIED, EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT. OI.LTC.Supply AgreementPage 12 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 13.4In the event of a breach of the warranty in Section 13.3 above, OI or its AFFILIATES shall give LTC or the AUTHORIZED LTC AFFILIATEnotice of such breach. Upon receipt of such notice, LTC or the AUTHORIZED LTC AFFILIATE shall promptly and without undue delay refundthe full price paid for the affected LTC PRODUCTS. 13.5OI covenants that it shall manufacture and distribute OI PRODUCTS and perform OI SERVICES using commercially reasonable standards of careand quality and no less standards of care and quality than OI uses in the manufacture of other similar products or performance of other similarservices. LTC shall have the right to visit and inspect the storage facilities of OI upon reasonable notice and during normal business hourssubject to approval by OI regarding timing of the visit, which approval shall not be unreasonably withheld. ARTICLE 14. LIMITATION OF LIABILITIES14.1SUBJECT TO ARTICLE 14.4, NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, NEITHER LTC NOR ITSAFFILIATES SHALL UNDER ANY CIRCUMSTANCES, BE LIABLE TO OI OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL,INCIDENTAL, INDIRECT, SPECIAL OR EXEMPLARY DAMAGES OF ANY KIND, ARISING OUT OF OR RELATED TO ANY TRANSACTIONCONTEMPLATED HEREUNDER, INCLUDING BUT NOT LIMITED TO LOST PROFITS OR LOSS OF BUSINESS, EVEN IF LTC OR ITSAFFILIATES ARE APPRISED OF THE LIKELIHOOD OF SUCH DAMAGES OCCURRING. 14.2EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS STATED IN THIS AGREEMENT, NEITHER LTC NOR ITSAFFILIATES MAKE ANY ADDITIONAL WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED OR STATUTORY, AS TO ANYMATTER WHATSOEVER. LTC AND ITS AFFILIATES EXPRESSLY DISCLAIM ANY AND ALL IMPLIED WARRANTIES OFMERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, INCLUDING ANY PURPOSE FOR THE FIELD OF USE AND LTC ANDITS AFFILIATES EXPRESSLY DISCLAIM ANY AND ALL WARRANTIES THAT THE USE OF LTC PRODUCTS, INCLUDING THE USE OFLTC PRODUCTS IN THE MANUFACTURE OF OI PRODUCTS OR ANY COMPONENT THEREOF, OR THE USE OR TRANSFER OF SUCH OIPRODUCTS OR COMPONENTS THEREOF BY OR TO ANY AFFILIATE OR THIRD PARTY, AND/OR ANY RESULTS OBTAINED BY USINGSUCH LTC PRODUCTS OR OI PRODUCTS OR COMPONENT THEREOF ARE OR WILL BE FREE FROM INFRINGEMENT OF ANY PATENTOR OTHER RIGHTS OF THIRD PARTIES; AND THIS ALLOCATION OF RISK BETWEEN THE PARTIES IS REFLECTED IN THE TERMS OFTHIS AGREEMENT AND IS AN ESSENTIAL ELEMENT OF THE BARGAIN BETWEEN THE PARTIES. OI SHALL NOT HAVE THE RIGHTTO MAKE OR PASS ON, AND SHALL TAKE ALL MEASURES NECESSARY TO ENSURE THAT NEITHER IT NOR ANY OF ITS AGENTS,EMPLOYEES, AFFILIATES, OR DISTRIBUTORS, OR AGENTS OR EMPLOYEES THEREOF MAKE OR PASS ON, ANY SUCH WARRANTYOR REPRESENTATION ON BEHALF OF LTC OR ITS AFFILIATES TO ANY END-USER OR OTHER THIRD PARTY. OI.LTC.Supply AgreementPage 13 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 14.3SUBJECT TO ARTICLE 14.4, UNDER NO CIRCUMSTANCES SHALL THE TOTAL LIABILITY OF ALL KINDS (i) OF LTC AND ITSAFFILIATES, ARISING OUT OF OR RELATED TO THIS AGREEMENT INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY CLAIMSHEREUNDER, REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT,TORT, OR ANY OTHER LEGAL THEORY, EXCEED THE TOTAL AMOUNT PAID BY OI COLLECTIVELY TO LTC AND ITS AFFILIATESHEREUNDER (DETERMINED AS OF THE DATE OF ANY FINAL JUDGMENT IN SUCH ACTION); (ii) OF OI AND ITS AFFILIATES, ARISINGOUT OF OR RELATED TO THIS AGREEMENT INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY CLAIMS HEREUNDER,REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, OR ANYOTHER LEGAL THEORY, EXCEED THE TOTAL PURCHASE PAYMENTS OBLIGATED BY OI COLLECTIVELY TO LTC AND ITSAFFILIATES HEREUNDER (DETERMINED AS OF THE DATE OF ANY FINAL JUDGMENT IN SUCH ACTION). 14.4Nothing in this AGREEMENT shall limit or exclude the liability of either Party for: (i)death or personal injury resulting from negligence; or (ii)fraud or fraudulent misrepresentation; or (iii)the indemnities contained in Article 15; or (iv)the deliberate default or wilful misconduct of that Party, its employees, agents or subcontractors; or (v)breach of the Confidentiality Agreement. 14.5IT IS EXPRESSLY UNDERSTOOD AND AGREED THAT EACH AND EVERY PROVISION OF THIS AGREEMENT WHICH PROVIDES FOR ALIMITATION OF LIABILITY, DISCLAIMER OF WARRANTIES OR EXCLUSION OF DAMAGES, IS INTENDED BY THE PARTIES TO BESEVERABLE AND INDEPENDENT OF ANY OTHER PROVISION AND TO BE ENFORCED AS SUCH. 14.6OI's exclusive remedy under this AGREEMENT with regard to the supply of LTC PRODUCTS, and the entire liability hereunder of LTC and itsAFFILIATES in contract, tort, or otherwise, shall be for the respective AUTHORIZED LTC AFFILIATE to use reasonable efforts to providereplacement for any non-conforming LTC PRODUCTS, provided that notice of non-conformance is received as per paragraph 9.2 (non-conformance claims). If however, after repeated efforts, the respective AUTHORIZED LTC AFFILIATE is unable to provide LTC PRODUCTS inconformance with the specification agreed hereunder, then OI's exclusive remedy under this AGREEMENT and the entire liability hereunder ofLTC and its AFFILIATES in contract, tort or otherwise is to refund the amount paid by OI for the non-conforming LTC PRODUCTS.Notwithstanding the foregoing, LTC and its AFFILIATES shall have no liability for LTC PRODUCTS that are not used for the FIELD OF USE. 14.7OI shall maintain in effect product liability insurance, in an amount of at least [***], regarding the sale of OI PRODUCTS and the performance ofOI SERVICES. LTC shall maintain at its own expense, product liability insurance in an amount of at least [***]covering the LTC PRODUCTS,except as incorporated into OI PRODUCTS or used in OI SERVICES. OI.LTC.Supply AgreementPage 14 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 15. INDEMNIFICATION15.1OI shall indemnify, defend and hold harmless LTC and its AFFILIATES, and their respective directors, officers, employees, and agents ("LTCIndemnitees"), from and against any and all liabilities claimed by any THIRD PARTY and including but not limited to demands, expenses(including, without limitation, costs of investigation, attorneys and professional fees and other costs of litigation, and to the extent permitted bylaw, fines, penalties and forfeitures in connection with any proceedings against the LTC Indemnitees), losses or causes of action, and settlementamounts, to the extent that such claimed liabilities arise out of or relate in any way to the possession, manufacture, use, sale, transfer, distributionor other disposition of OI PRODUCTS or OI SERVICES, including any use or sale of LTC PRODUCTS whether or not in combination with othersubstances, in each case,by or on behalf of OI, its AFFILIATES, or its or their DISTRIBUTORS, whether based on breach of warranty, negligence,product liability, infringement, misappropriation, or otherwise, except to the extent that such claimed liabilities are the result of negligence,recklessness, or willful misconduct by LTC or its AUTHORIZED LTC AFFILIATE. OI shall defend against any such claimed liabilities at its ownexpense, provided that LTC promptly notifies OI on learning of such claimed liabilities and cooperates with OI in such defense. 15.2LTC shall indemnify, defend and hold harmless OI and its AFFILIATES, and their respective directors, officers, employees, and agents ("OIIndemnitees"), from and against any and all liabilities claimed by any THIRD PARTY and including but not limited to demands, expenses(including, without limitation, costs of investigation, attorneys and professional fees and other costs of litigation, and to the extent permitted bylaw, fines, penalties and forfeitures in connection with any proceedings against the OI Indemnitees), losses or causes of action, and settlementamounts, where such claimed liabilities arise out of or relate in any way to the manufacture, sale, or transfer of LTC PRODUCTS by LTC or itsAFFILIATES to OI or its AFFILIATES, whether based on breach of warranty, negligence, product liability, infringement, misappropriation, orotherwise, except to the extent that such claimed liabilities are the result of negligence, recklessness, or willful misconduct by OI or itsAFFILIATES. LTC shall defend against any such claimed liabilities at its own expense, provided that OI promptly notifies LTC on learning ofsuch claimed liabilities and cooperates with LTC in such defense. OI.LTC.Supply AgreementPage 15 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 16. TERM AND TERMINATION16.1This AGREEMENT shall commence on the EFFECTIVE DATE and, unless terminated earlier as provided herein, all obligations of LTC or itsAFFILIATES to supply LTC PRODUCTS hereunder shall expire on December 31, 2019. 16.2In the event that (a) OI’s twelve-month forecast provided under Section 4.4 does not reflect any anticipated purchases of an LTC PROUDCT or(b) no purchases of an LTC PRODUCT are made for a consecutive twelve (12)-month period, either Party may terminate this AGREEMENT withrespect to such LTC PRODUCT upon sixty (60) days' prior written notification to the other Party according to paragraph 17.1 (noticerequirements). 16.3If either OI or LTC breaches any material condition of this AGREEMENT, the aggrieved Party may give written notice of the alleged breach tothe other Party. The receiving Party shall have forty-five (45) days from the date of notice to cure (the “CURE PERIOD”) the identified default oralleged breach. If the identified default or alleged breach is not cured during the CURE PERIOD, this AGREEMENT shall terminate on theexpiration of the CURE PERIOD. A failure on the part of an AFFILIATE of a Party to comply with the terms of this AGREEMENT shallconstitute a breach of this AGREEMENT by such Party. 16.4If OI becomes insolvent or enters into liquidation (excepting liquidation of a solvent company for organizational purposes) or makes anassignment for the benefit of creditors, or if proceedings for voluntary bankruptcy are instituted on behalf of OI, or if OI is declared bankrupt orinsolvent, LTC may, at its election, terminate this AGREEMENT immediately by giving written notice of termination to OI. 16.5Upon any expiration or termination of the AGREEMENT, each Party shall promptly return to the providing Party, at its request, allCONFIDENTIAL INFORMATION of the providing Party, or verification by an authorized signatory of the receiving Party that all suchCONFIDENTIAL INFORMATION was destroyed. However, one (1) copy may be retained in the receiving Party's legal files for purposes of recordkeeping. 16.6Articles 12 (confidentiality), 13 (warranties), 14 (limitation of liabilities), 15 (indemnification), and 18 (dispute resolution), and paragraphs 16.5(copy of CONFIDENTIAL INFORMATION), and this paragraph 16.6 shall survive the expiration or termination of this AGREEMENT for anyreasons. OI.LTC.Supply AgreementPage 16 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 17. NOTICE17.1Any notices required or permitted to be given under this AGREEMENT shall be deemed given on the date submitted in writing: (a) personally;or (b) by a letter delivered to a courier guaranteeing next day service; or (c) by facsimile or e-mail, with confirmation by prepaid first class lettersent the same day. If to LTC:THERMO FISHER SCIENTIFIC, INC.Life Technologies Corporation5823 Van Allen WayCarlsbad, CA 92008USAAttention: Contract Management & Analytics (CMA)E-mail: LMCC@thermofisher.com With a copytoTHERMO FISHER SCIENTIFIC, INC.Life Technologies Corporation 29851 Willow Creek RoadEugene, OR 97402-9132USAAttention: Business Development DepartmentFacsimile: 541-335-0354 If to OI:OXFORD IMMUNOTEC LIMITED94C Innovation DriveMilton Park, AbingdonOxfordshire OX14 4RZUnited KingdomAttention: Peter Gaskell With a copyto:OXFORD IMMUNOTEC USA, INC.General Counsel700 Nickerson RoadSuite 200Marlborough, MA 01752USA 17.2Any Party may change its designated address or other contact information by notice to the other Party in the manner provided in this Article. OI.LTC.Supply AgreementPage 17 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ARTICLE 18. DISPUTE RESOLUTION18.1In the event any Party claims breach of this AGREEMENT, the Parties shall consult with each other in good faith on the most effective means tocure the breach and to achieve any necessary restitution of its consequences. This consultation shall be undertaken within a period of ten (10)days following the receipt of a written request to consult, and the consultation period shall not exceed thirty (30) days. During the consultationperiod, neither litigation nor arbitration may be pursued until attempts at consultative dispute resolution have been exhausted. 18.2Subject to Article 18.3, any dispute arising out of or in connection with this AGREEMENT, including any question regarding its existence,validity or termination, shall be referred to and finally resolved by arbitration under the Commercial Arbitration Rules of the AmericanArbitration Association (“Rules”) then in effect , which Rules are deemed to be incorporated by reference into this clause. The number ofarbitrators shall be one. The seat, or legal place, of arbitration shall be New York. The language to be used in the arbitral proceedings shall beEnglish. 18.3This paragraph shall not apply to, and no arbitration proceeding shall deal with, disputes relating to the issues of the scope, validity and/orenforceability of any of the intellectual property licensed to any Party hereunder. In no event shall a demand for arbitration be made after the datewhen the initiation of a legal or equitable proceeding based on such dispute in question would be barred by the applicable statute of limitations. ARTICLE 19. MISCELLANEOUS19.1Amendments. No change, modification, extension, termination, or waiver of this AGREEMENT, or any of the provisions herein contained, shallbe valid unless made in writing and signed by duly authorized representatives of the Parties hereto, except as expressly provided herein. 19.2Neither Party shall assign this AGREEMENT or any of its rights or liabilities hereunder without the prior written consent of the other Party;provided, however, that either Party may assign all or any part of its rights and obligations under this AGREEMENT to an AFFILIATE orsuccessor in the event of a merger, acquisition, change of CONTROL, reorganization or sale of substantially all of the assets of such Party. 19.3Binding Effect. This AGREEMENT shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. 19.4Counterparts. This AGREEMENT may be executed in two or more counterparts, each of which shall be deemed an original, but all of whichtogether shall constitute one and the same instrument. 19.5Exhibit Incorporation. All Exhibits cited herein are incorporated by reference and made a part of this AGREEMENT. 19.6Force Majeure. Any failure or delay in performance by either Party to this AGREEMENT caused by an event beyond the reasonable control ofsuch Party shall not be deemed a breach of this AGREEMENT, such causes including but not limited to: natural disasters; insurrections and otherhostilities; acts of governments or government agencies; and strikes or other labor disturbances. On occurrence of any such event, the Partywhose performance is affected shall promptly give written notice to the other Party in accordance with 17.1 (Notice) and its best estimate of theextent and duration of its effect. The term of this AGREEMENT shall then be suspended for a corresponding period of time. If such period ofsuspension lasts for a period of six (6) months, the Party not affected by such event shall be entitled to terminate this AGREEMENT by providingat least one (1)-month notice. OI.LTC.Supply AgreementPage 18 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 19.7Governing Law and Venue. This AGREEMENT and all matters connected with the performance thereof shall be governed by and construed andenforced in accordance with the laws of New York, except that any dispute with respect to infringement, validity, or enforceability of any patentor published patent application shall be governed by and construed and enforced in accordance with the laws of the jurisdiction in which suchpatent is issued or such patent application is published. Unless otherwise agreed between the Parties, any litigation or other dispute resolutionbetween the Parties relating to this AGREEMENT shall take place in New York. 19.8Headings. The Article and paragraph headings, and paragraph parenthetical cross-references contained herein are for the purposes of convenienceof reference only and are not intended to define or limit the contents of said Articles or paragraphs. 19.9Independent Contractors. Nothing in this AGREEMENT is intended nor is to be construed as to constitute the Parties as partners, joint venturers,or principal and agent with respect to this AGREEMENT. Neither Party shall have any express or implied authority to bind any other Party to anyother agreement, contract, obligation or undertaking with any THIRD PARTY. 19.10Interpretation. Whenever required by the context, the singular term shall include the plural, the plural term shall include the singular, and thegender of any pronoun shall include all genders. Whenever the last day for the exercise of any privilege or the discharge of any duty hereundershall fall on a Saturday, Sunday, or national or local holiday, the Party having such privilege or duty shall have until 5:00 pm on the nextsucceeding business day to exercise such privilege or to discharge such duty. It is further agreed that no usage of trade or other regular practicebetween the Parties hereto shall be used to interpret or alter the terms of this AGREEMENT. Since the Parties have participated jointly in thenegotiation and drafting of this AGREEMENT, in the event an ambiguity or question of interpretation arises, no presumption or burden of proofshall arise favoring or disfavoring any Party by virtue of authorship of any provision of this AGREEMENT. OI.LTC.Supply AgreementPage 19 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 19.11Prior Agreements. This AGREEMENT together with the Exhibits hereto, sets forth the entire understanding between the Parties with respect tothe matters dealt with herein and supersedes any and all prior agreements (including the Original Agreement), written or oral, previously enteredinto by the Parties covering the matters dealt with herein. 19.12Severability. If any provision of this AGREEMENT is in violation of any law or is found to be otherwise unenforceable by a court or competentadministrative body from which there is no appeal, or no appeal is taken, such provision shall be deleted and the Parties shall negotiate in goodfaith to substitute for any such invalid or unenforceable provision, a valid and enforceable provision that achieves to the greatest extent possiblethe economic, legal and commercial objectives of the invalid or unenforceable provision. 19.13Waiver. No delay on the part of any Party hereto in exercising any power or right hereunder shall operate as a waiver thereof, nor shall any singleor partial exercise of any power or right hereunder preclude other or further exercise thereof or the exercise of any other power or right. Each of the undersigned represents and warrants that he is duly authorized to execute this AGREEMENT and thereby bind his respective Party and that allrequired approvals have been obtained for the execution of this AGREEMENT, which AGREEMENT shall be binding on the Parties as of theEFFECTIVE DATE. For purposes hereof, a facsimile of a signed copy shall have the same force and effect as an original signed AGREEMENT. OI.LTC.Supply AgreementPage 20 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. LIFE TECHNOLOGIES CORPORATIONOXFORD IMMUNOTEC LIMITED By:/s/ Deborah Day Barbara By:/s/ Peter Gaskell Name/Title:Sr. Director, Therapeutics Name/Title:VP, Operations Date:9 January 2018 Date:20 Dec 2018 OI.LTC.Supply AgreementPage 21 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Exhibit A: AUTHORIZED LTC AFFILIATES For the purchase of LTC PRODUCTS that will be supplied to OI or its AFFILIATES in the US, the AUTHORIZED LTC AFFILIATE is: Life Technologies CorporationA Thermo Fisher Scientific company3175 Staley RoadGrand Island, NY 14072USA To Order:E-mail: CustomMedia@lifetech.com For the purchase of LTC PRODUCTS that will be supplied to OI or its AFFILIATES in the UK, the AUTHORIZED LTC AFFILIATE is: Life Technologies CorporationA Thermo Fisher Scientific company3 FountainDriveInchinnan Business ParkPaisley, UKPA4 9REPhone: 0044 141 814 6100E-mail: mpinquiries-orders@lifetech.com OI FACILITY Oxford Immunotec LimitedOxford Immunotec LimitedOxford Immunotec USA, Inc.94C Innovation Drive143 Park Drive320 Norwood Park SouthMilton Park, AbingdonMilton Park, Abingdon,Norwood, MA 02062Oxfordshire OX14 4RZOxfordshire, OX14 4SEUSAUnited KingdomUnited Kingdom OI.LTC.Supply AgreementPage 22 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. LTC PRODUCTS LTC PRODUCTS that are available to be supplied under this AGREEMENT, for use as set forth in Article 3 (scope of agreement), are identified in thefollowing table: LTC PRODUCT(name)Commercial Use Product No.UNIT SizeAIM V® MediumA18398DJ500 mLAIM V® MediumA18398SA50 mL PRICING OF LTC PRODUCTS1LTC PRODUCTInitial Purchase Price toOIMinimumShipment/Minimum Order(UNITS per shipment/order)2 Standard Price ChangeAIM V ® 500mL package in Gibco Boxy Bottle[***][***][***]AIM V® 50mL Custom Pkg[***][***][***]1 Subject to the provisions of paragraph 4.1 (source of supply) and Article 7 (pricing)2 As set forth in paragraph 4.3 (required minimums) of this AGREEMENT Minimum Annual Purchase Upon the EFFECTIVE DATE and for each YEAR during the TERM OI shall purchase from the respective AUTHORIZED LTC AFFILIATE, a MinimumAnnual Purchase of LTC PRODUCTS as set forth below. YEARMinimum Annual Purchase2019 and each subsequent YEAR that this AGREEMENT is in effect[***]1 Failure to meet these Minimum Annual Purchase amounts for a given YEAR will incur a [***] percent ([***]%) increase in the price of the LTCPRODUCT for the following YEAR. For purposes of clarification, in the event OI meets or exceeds the Minimum Annual Purchase amount for a givenYEAR, the price of the LTC PRODUCT for the following YEAR shall not be subject to an increase. OI.LTC.Supply AgreementPage 23 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. LABEL OI.LTC.Supply AgreementPage 24 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIALIS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. SPECIFICATIONS SpecificationResultBottle Size[***][***]Label[***][***]Packaging/Seals[***][***]Grade[***][***]ALBU MAX (Bovine Serum Albumin)[***][***]L-Glutamine[***][***]Streptomycin Sulphate[***][***]Gentamicin Sulphate[***][***]pH[***][***]Osmolality[***][***]Sterility Testing[***][***]AIM V QC Assay[***][***]Endotoxin Testing[***][***]Mycoplasma detection[***][***]HCV Antibody Screening[***][***]Hepatitis B Surface Antigen Screening[***][***]HIV 1 & 2 Antibody Screening[***][***] OI.LTC.Supply AgreementPage 25 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. OI.LTC.Supply AgreementPage 26 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Exhibit B:LTC PROPRIETARY RIGHTS Trademark AIM V®GIBCO® PatentsBoxy Bottle Patents OI.LTC.Supply AgreementPage 27 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Exhibit C:Confidentiality Agreement (pdf attached) CONFIDENTIALITY AGREEMENT This Confidentiality Agreement ("Agreement") is entered into by and between LIFE TECHNOLOGIES CORPORATION ("LTC"), a Delawarecorporation, with a principal business address at 29851 Willow Creek Road, Eugene, Oregon 97402 and Oxford lmmunotec, Ltd. ("OI"), a companyincorporated under the laws of England and Wales, with a principal business address at 94C Innovation Drive, Milton Park, Abingdon, Oxfordshire, OX144RY, U.K., effective as of August 12, 2013. RECITALS WHEREAS, LTC and OI are parties to a Supply and Distribution Agreement having an effective date of August 12, 2013 (the "SupplyAgreement"); WHEREAS, in connection with the Supply Agreement, LTC and OI may from time to time exchange or disclose information which isconfidential, proprietary or a trade secret; and WHEREAS, LTC and OI wish to memorialize the terms and conditions under which such confidential, proprietary or trade secret information maybe disclosed and used. NOW, THEREFORE, in consideration of the foregoing, and other good and valuable consideration, the receipt and sufficiency of which is herebyacknowledge and agreed, LTC and OI agree to the terms and conditions set forth herein. AGREEMENT 1. The parties' representatives for disclosing or receiving Confidential Information (as defined herein) respectively are:For LTC: Stephen Chamberlain or his designeeFor OI: Jon Watts or his designee 2. "Confidential Information" means any commercial or technical data, documents, materials, procedures, and similar information that is not generallyknown to the public and is maintained in a confidential manner and that is disclosed under this Agreement and in connection with the Supply Agreement.For sake of clarity, Confidential Information include any information derived through research or development activities and other technology, includingmaterials business, financial or marketing plans or information relating to the LTC PRODUCTS, OI PRODUCTS or OI OTHER PRODUCTS (as those termsare defined in the Supply Agreement). Confidential Information in tangible or written form must be conspicuously marked as such. ConfidentialInformation in intangible or verbal form should be identified as such and then a summary of the Confidential Information provided within thirty (30) daysof disclosure. 3. The burdens of non-use and confidentiality on the parties to this Agreement will continue until terminated by mutual agreement of the parties. OI.LTC.Supply AgreementPage 28 of 35  4. Each Party shall use the Confidential Information only for purposes relating to the obligations and duties arising under or in connection with theSupply Agreement. Neither Party will disclose the Confidential Information to any person except those employees, consultants, and subcontractors towhom it is necessary to disclose the Confidential Information and any such disclosure to consultants or subcontractors shall be made solely pursuant to awritten agreement with terms at least as restrictive as those specified herein. All consultants or subcontractors who receive Confidential Information mustbe identified in writing to the Party who disclosed the information. The receiving Party shall protect the Confidential Information of the disclosing Partyby using the same degree of care as receiving Party uses to protect its own Confidential Information, but in any event no less than a reasonable degree ofcare. 5. The duties of confidentiality under this Agreement shall apply to any and all Confidential Information disclosed by either Party, including but notlimited to, such Confidential Information disclosed during site visits, in any oral disclosure or any written document, memorandum, report,correspondence, drawing or other material, or computer-readable media, developed or prepared by a Party or any of its representatives. 6. Notwithstanding any other provision of this Agreement, Confidential Information shall not include any item of information which: (a) is within thepublic domain prior to the time of the disclosure by a Party or thereafter becomes within the public domain other than as a result of disclosure by a Partyin violation of this Agreement; (b) was, on or before the date of disclosure, in the possession of a Party, as evidenced by written records of such Party; (c) isacquired by a Party from a third party not under an obligation of confidentiality; or (d) is independently developed by a Party without use of or referenceto the Confidential Information of the other Party, as evidenced by written records of such Party. 7. Each Party agrees to return all Confidential Information, including materials, received from the other Party upon request except that a Party mayretain in its confidential files one copy of the Confidential Information for record purposes only. 8. In the event that a Party or anyone to whom it transmits the Confidential Information pursuant to this Agreement becomes legally required todisclose any such Confidential Information, such Party shall provide the other with prompt notice so that the notified Party may seek a protective order orother appropriate remedy and/or waive compliance with the provisions of this Agreement. In the event that such protective order or other remedy is notobtained, the Party subject to the legal requirement to disclose Confidential Information shall furnish only that portion of the Confidential Informationthat it legally required to be furnished in the opinion of such Party's counsel. 9. This Agreement constitutes the entire understanding between the parties hereto with respect to the subject matter hereof and merges any and all prioragreements, understanding, and representations. The Parties expressly acknowledge and agree that the Confidentiality Agreement dated September 1,2006 between OI and Invitrogen Corporation is merged into this Agreement and the obligations of that agreement continue unabated under thisAgreement. OI.LTC.Supply AgreementPage 29 of 35  10. The Parties acknowledge and agree that the obligations of this Agreement extend to each Party's AFFILIATES (as defined in the Supply Agreement)that purchase or supply items pursuant to the Supply Agreement. OXFORD IMMUNOTEC LIMITED LIFE TECHNOLOGIES CORPORATION /s/ Peter Edwardson 20 Aug 13 /s/ Rolando Brawer Aug 15, 2013 Authorized Signature Date Authorized Signature Date Name: P. Edwardson Name: Rolando Brawer Title: General Manager Title: Director, Outlicensing Approved as to legal form, /s/ Allegra J. Helfenstein Authorized SignatoryAllegra J. HelfensteinLife Technologies Corporation OI.LTC.Supply AgreementPage 30 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXHIBIT DQUALITY AGREEMENT The following quality provisions are agreed to by Customer and LTC and hereby incorporated into this Agreement. Any capitalized terms used in thisExhibit that are not otherwise defined shall have the meanings set forth in the Supply Agreement. The Supply Agreement shall take precedence over thesequality provisions in relation to any conflicts between the Supply Agreement and these quality provisions. 1.Quality Management System.LTC will maintain a Quality Management System that complies with the current version of ISO 13485. 2.Product Complaints. Customer will notify LTC, in writing and in a timely manner, of any confirmed customer complaints or Medical Adverse Event Reports that implicateLTC’s processes (i.e., manufacturing, filling, and packaging/distribution). LTC shall cooperate with Customer, in investigating any such complaints. LTC shall, at Customer’s request and at LTC’s cost and expense, provideCustomer with reasonable assistance in gathering information concerning complaints. LTC, if requested by Customer, will conduct internal investigations, record reviews, and sample evaluations as required to determine the validity of thecomplaint and report the results to Customer. The nature of the complaint will dictate the appropriate response time. In the event LTC and the Customer cannot come to an agreement on whether the customer complaint is confirmed, a technical expert will be selected andconfirmed by both parties. The decision made by the technical expert will be binding and the dissenting party agrees to bear the charges of the expert. 3.Field Actions and Recalls. In the event Customer is required or voluntarily decides to recall or withdraw a Customer product that potentially implicates LTC’s processes, LTC willfully cooperate with Customer in connection with such a field action, recall or withdrawal. OI.LTC.Supply AgreementPage 31 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 4.Process Control LTC will ensure that all processes that directly affect the quality of the Products are clearly defined and carried out under controlled conditions. LTC’sprocess control program must include: ●Documented procedures regarding how processes are to be performed and measured. ●Use of suitable equipment and environment to produce and store raw materials and products. ●Documentation of changes regarding production and process controls. ●Trained, qualified personnel to perform operations on the Products For example where certifications are required only certified operators are toperform these operations. ●Defined criteria for workmanship standards such as representative samples, specifications or illustrations. ●Validation of processes that cannot be fully verified. 5.Changes to LIFE Processes or Materials LTC shall notify Customer in writing of any significant process changes that could affect Customer’s products or quality systems prior to implementationof the proposed change. Significant process or material changes include but are not limited to, changes to the production processes, manufacturingmaterials, manufacturing location, outsourced product and or services or equipment associated with the Products. If LTC subcontracts to third parties for products and/or services, LTC will ensure that these subcontractors are in compliance with LTC’s documentedQuality Management System, including those for monitoring subcontractors. If requested by Customer, LTC shall provide validation protocols and applicable results of validation activities when requesting any changes to processesor equipment for which validation requirements have been established and agreed upon. Without limiting the foregoing, LTC agrees to notify Customer before implementing any change affecting the Product’s Fit, Form or Function at LTC’slocation (including changes in the design, specifications, raw materials, manufacturing processes and materials, equipment used, manufacturing location,outsourcing of operations or method of producing the Products). LTC shall provide a change notification to Customer at least 3 months prior toimplementing the described change. In certain circumstances, such as where the change impacts a regulatory clearance or approval, OIL may require thatthe implementation of the change be delayed beyond six months after obtaining OIL written approval, or that sufficient stock be held by the SUPPLIER tocover the likely duration of any re-registration process. OI.LTC.Supply AgreementPage 32 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 6.Product Identification and Traceability LTC will maintain a system(s) to: • Protect the Products from contamination by foreign materials.• Establish unique identification of individual product or batches from receipt through all stages of production and delivery.• Control the segregation of the Product through all production processes. 7.Inspection LTC will ensure that all incoming product including raw material, whether from an outside supplier or from a Customer facility are conforming to allrequired Specifications. LTC will establish and maintain quality records of in-process and final inspection criteria as well as document results ofinspections performed on the Products. When applicable, first article layout inspections will be conducted and documented by LTC. When first article layout samples are required they will besubmitted according to Customer’s site requirements. 8.Non-Conforming Product LTC shall establish and maintain procedures for control of non-conforming products. This includes identification of nonconformance, segregation and/orquarantine, investigation of cause, evaluation and disposition of non-conformities. At the request of Customer, LTC shall perform investigations and take corrective actions. 9.Records LTC will maintain records for 5 years after expiry for all Products supplied to Customer. If LTC ceases business with Customer, or closes its facility, thenthe LTC will notify Customer in writing immediately and supply Customer all requested manufacturing and quality related documents LTC will usecommercially reasonable efforts to maintain and store documents in a manner to prevent loss or deterioration. Customer, its employees agents, contractors and assigns will have timely access to all manufacturing and quality records for the Products supplied toCustomer, either directly or by a third party in a timely manner. OI.LTC.Supply AgreementPage 33 of 35  10.FDA or Governmental Authority Inspections In the event that the FDA, Governmental Authority, EU Notified Bodies under the IVD regulation or critical supplier audits requests an inspection ofLTC’s facilities and records relative to the Products purchased under the Supply Agreement, LTC agrees to comply with such request and will notifyCustomer immediately of any scheduled FDA or Governmental Authority audit at LTC’s facility. LTC agrees to provide to Customer copies of any writtendocumentation relating to an FDA or Governmental Authority inspection that impacts the Products provided to Customer. This includes any 483 findings,warning letters, or any other FDA or Governmental Authority actions. 11.Quality Reviews Employees and representatives of OI or OI AFFILATES shall have the right to perform, and to have third parties perform on behalf of OI, comprehensiveaudits of LTC’s products, processes and quality program at LTC’s facility, or at the facilities of LTC’s subcontractors, as needed and at reasonableintervals, but not more than once per YEAR, to ensure proper product quality systems are in effect and to confirm compliance with applicable qualityprovisions herein. Any costs incurred by such audit shall be paid by OI. LTC shall not be obligated to consent to conduct of an audit more than once perYEAR (other than for cause). Any audit shall be under LTC’s reasonable confidentiality, health and safety and security restrictions. LTC may require thataudits of trade secret materials and/or methods be conducted by an independent THIRD PARTY. If corrective actions are needed, LTC agrees to provideCorrective and Preventative Action plans as required. LTC shall also be entitled to send technical representatives and representatives of regulatory agencies to OI’s premises to audit and inspect themanufacture of the OI PRODUCT no more than once per YEAR (other than for cause), upon giving reasonable advance notice. Any costs incurred by suchaudit shall be paid by LTC. 12.Certificates of Analysis LTC shall issue a Certificate of Analysis for each lot supplied by LTC using the following templates. [Templates Follow on Next Page] OI.LTC.Supply AgreementPage 34 of 35  THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL ISMARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Template C of A (A18398SA and A18398DJ)[***] OI.LTC.Supply AgreementPage 35 of 35 Exhibit 10.47 SEPARATION AGREEMENT This Separation Agreement (“Agreement”), is made by and between Oxford Immunotec USA, Inc., with a business address of 700 NickersonRoad, Suite 200, Marlborough, MA 01752 (the “Company”) and Richard A. Wenstrup (the “Employee” or “you” or “your”) on the day on which theCompany has executed the Agreement below. WHEREAS, the Company and Employee are parties to that certain Employment Agreement with an effective date of July 24, 2017 (the“Employment Agreement”), which included provisions relating to severance payable to the Employee upon termination of employment under certaincircumstances; WHEREAS, the Company and Employee have discussed Employee’s resignation and a change to the Employment Agreement effective uponsuch resignation and now wish to memorialize their mutual agreement with regard to such retirement. NOW, THEREFORE, in light of the foregoing, the provisions set forth in this Agreement and other good and valuable consideration, the receiptand sufficiency of which are hereby acknowledged and agreed, the parties agree as follows. 1.Employment Status; Final Payments; Benefits Information: (a) Termination Date: Your separation from the Company shall be effective March 8, 2019 (the “Termination Date”). As of the TerminationDate, your salary will cease, and any entitlement you have or might have under a Company-provided benefit plan, program or practice will be terminated,except as required by federal or state law or as otherwise described below. (b) Health Benefits: If you elect continued health insurance coverage under and in accordance with the Consolidated Omnibus BudgetReconciliation Act of 1985 (“COBRA”), under the same plans available to active Company employees, and under the same rules, restrictions andregulations applicable thereto, you will be responsible for any and all payments for the elected period of continued health insurance coverage underCOBRA. You will receive additional COBRA information under separate cover. (c) Receipt of final payments: You hereby acknowledge that on your Termination Date you will have received payment for all wages earnedbut unpaid, your bonus based on 2018 performance and all vacation time accrued but unused as of the Termination Date. You further acknowledge that asof the Termination Date, the Employment Agreement shall be terminated and no longer be in force or effect, except for those provisions which by its termssurvive termination, and that this Agreement shall govern the terms of your relationship with the Company following the Termination Date. Effective withthe Termination Date, the Company shall have no further obligations in relation to any office space leased by you in connection with your employmentwith the Company. (d) Equity Matters: All vesting of options shall cease as of the Termination Date in accordance with the stock option and restricted share unitagreements between you and the Company (the “Stock Option Agreements”). If you have vested options, they must be exercised within the time periodsdefined in your Stock Option Agreement(s). Further information about your options is available through Global Shares.  2. Consideration: In exchange for, and in consideration of, your execution of this Agreement, including, without limitation, the release provisionsin Sections 4, 5 and 6 the Company will provide you with “Separation Pay” equivalent to 10.5 months (45.5 weeks) of your current Base Salary, for a totalof $350,000.11 less applicable taxes. Payments will be made to you according to the regular company payroll schedule beginning immediately after theEffective Date of this Agreement (defined below). The Company is not obligated to provide you any of the Separation Pay outlined in this paragraphbefore the Effective Date of this Agreement. If the Company does not make one or more payments of Separation Pay on a regular payroll date because thisAgreement has not yet become effective, the Company shall make all such withheld payments by the first payroll date after the Agreement becomeseffective. 3. Taxes: Except as noted herein, all payments set forth in this Agreement shall be subject to all applicable federal, state and/or local withholdingand/or payroll taxes, and the Company may withhold from any amounts payable to you (including any amounts payable pursuant to this Agreement) inorder to comply with such withholding obligations. You acknowledge and agree that you are responsible to pay any applicable taxes on theconsideration received hereunder. You acknowledge that you are not relying upon the advice or representation of the Company with respect to the taxtreatment of any of the benefits set forth herein. The parties intend for the terms of this Agreement to be paid in such a manner to be compliant withSection 409A of the Internal Revenue Code of 1986, as amended (“Code Section 409A”), or, as applicable, to be exempt from Code Section 409A.Notwithstanding the foregoing, the Company makes no representations or guarantees with respect to the taxation of any of the payments or benefits setforth herein, including taxation pursuant to Code Section 409A. 4. Release: In exchange for the amounts described in Section 2, which are in addition to anything of value to which you are entitled to receive, andother good and valuable consideration, the sufficiency of which is hereby acknowledged, you and your representatives, agents, estate, heirs, successorsand assigns, absolutely and unconditionally hereby release, remise, discharge, indemnify and hold harmless the Company Releasees (defined to includethe Company and/or any of its parents, subsidiaries, divisions, or affiliates, predecessors, successors or assigns, and its and their respective current and/orformer partners, directors, shareholders/stockholders, officers, managers, supervisors, employees, attorneys, insurers, re-insurers, representatives, and/oragents, all both individually and in their official capacities), from any and all actions or causes of action, suits, claims, complaints, contracts, liabilities,agreements, promises, torts, debts, damages, controversies, judgments, rights and demands, whether existing or contingent, known or unknown, suspectedor unsuspected, which arise out of your employment with, change in employment status with, and/or separation of employment from, the Company. Thisrelease is intended by you to be an all-encompassing general release which shall fully and completely release any claims, whether specifically enumeratedherein or not, that you may have or have had against the Company Releasees arising from conduct occurring up to and through the date of thisAgreement, including, but not limited to, any claims arising from any federal, state or local law, regulation or constitution dealing with employment,employment benefits or employment discrimination including but not limited to such laws or regulations concerning discrimination on the basis of race,color, creed, religion, age, sex, sex harassment, sexual orientation, national origin, ancestry, genetic information, handicap or disability, veteran status,any military service or application for military service, gender identity and expression, or any other category protected under federal or state law; anycontract, whether oral or written, express or implied, including without limitation, any letter offering employment and any stock option agreement(s); anytort; any claim for equity or other benefits; or any other statutory and/or common law claim. This release includes, without limiting the generality of theforegoing, all claims, demands or actions under Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq., the Age Discrimination inEmployment Act of 1967, 29 U.S.C. § 621 et seq., the Civil Rights Act of 1991, 42 U.S.C. § 1981, the Americans with Disabilities Act of 1990, 42 U.S.C.§§ 12101-13, the Employment Retirement Income Security Act of 1974, 29 U.S.C. § 1001 et seq., the Massachusetts Fair Employment Practices Act,M.G.L. c. 151B, the Family and Medical Leave Act, 29 U.S.C. §§ 2601; the Fair Credit Reporting Act, 15 U.S.C. §1681; the Massachusetts Civil RightsAct, M.G.L. c. 12 §§ 11H and 11I; the Massachusetts Equal Rights Act, M.G.L. c. 93, and c. 149, § 1; the Massachusetts Wage Act, M.G.L. c. 149 § 148,and the Massachusetts Privacy Act, M.G.L. c. 214, §1B; all as amended; any other federal, state or local statute or regulation, and the common law of anystate, including without limitation, all claims for infliction of emotional distress, slander, libel or defamation of character; all claims asserting anywhistleblower, retaliation or public policy violation; and all claims for reinstatement, back pay, front pay, vacation pay, compensatory or punitivedamages, severance pay, attorneys’ fees, or costs. You specifically understand that this general release of claims includes, without limitation, a release ofclaims for alleged wages due, overtime or other compensation or payment including any claim for treble damages, waiting time penalties, attorneys’ feesand costs pursuant to any state and federal wage and hour law, including to the extent applicable, the Massachusetts Wage Act and State Overtime LawM.G.L. c. 149, §§148, 150 et seq. and M.G.L. c. 151, §1A et seq. Provided, however, that nothing herein shall prevent or restrict you from instituting anyaction or proceeding to enforce the terms of this Agreement and provided further, that nothing herein shall prevent or restrict you from instituting anyaction or proceeding against the Company for acts, incidents, occurrences, or inactions occurring after the execution of this Agreement. You not only release and discharge the Company Releasees from any and all claims as stated above that you could make on your own behalf or on behalfof others, but also those claims that might be made by any other person or organization on your behalf, and you specifically waive any right to recoverany damage awards as a member of any class in a case in which any claim(s) against the Company Releasees are made involving any matters. You represent that you have not filed or asserted any cause of action, claim, charge or other action or proceeding against the Company or any CompanyReleasees as of the Termination Date.  You represent and warrant to the Company that no portion of any claim, demand, cause of action, or other matter released by you herein, nor any portionof any recovery or settlement to which you might be entitled herein, has been assigned or transferred to any other person or entity, either directly or byway of subrogation or operation of law. You acknowledge that you have been granted by the Company all requested paid and/or unpaid leave to which you may have been entitled. Yourepresent that you are not aware of any facts that would support a claim by you against the Company for any violation of the Family and Medical LeaveAct. You further acknowledge that you have been properly paid for all time worked and are unaware of any facts that would support a claim by youagainst any of the Company for any claim of unpaid overtime or any other violation of the Fair Labor Standards Act or the Massachusetts Wage Act. 5. Waiver of Rights and Claims Under the Age Discrimination in Employment Act of 1967: Since you are 40 years of age or older, you have beeninformed that you have or might have specific rights and/or claims under the Age Discrimination in Employment Act of 1967, 29 U.S.C. §§ 621, et seq.(“ADEA”) and more specifically the Older Workers Benefit Protection Act, 29 U.S.C. § 626, et seq., and you agree that: (a) In consideration for the amounts described in Section 2, which you are not otherwise entitled to receive, you specifically waive such rightsand/or claims under the ADEA to the extent that such rights and/or claims arose prior to or on the date this Agreement was executed; (b) You understand that rights or claims under the ADEA which may arise after the date this Agreement is executed are not waived by you; (c) You acknowledge that you have been advised of your right to consult with your counsel of choice prior to executing this Agreement andyou have not been subject to any undue or improper influence interfering with the exercise of your free will in deciding whether to consult with counsel; (d) You have carefully read and fully understand all of the provisions of this Agreement, you knowingly and voluntarily agree to all of theterms set forth in this Agreement, and you acknowledge that in entering into this Agreement, you are not relying on any representation, promise orinducement made by the Company or its attorneys with the exception of those promises contained in this document; and (e) When the Company presented you with this Agreement, you were informed that you have at least 21 days to review this Agreement andconsider its terms before signing it. (f) The 21-day review period will not be affected or extended by any revisions, whether material or immaterial, that might be made to thisAgreement. (g) Per Section 12 herein, you may revoke this Agreement during the seven (7) day period following your execution of the Agreement, and theAgreement shall not be effective or enforceable until this period has passed without your revocation.  6. Accord and Satisfaction: The payments set forth in Sections 1 and 2 shall be complete and unconditional payment, settlement, accord and/orsatisfaction with respect to all obligations and liabilities of the Company Releasees to you and with respect to all claims, causes of action and damagesthat could be asserted by you against the Company Releasees or by the Company Releasees against you regarding your employment with, change inemployment status, and/or termination of employment from, the Company, including, without limitation, all claims for back wages, salary, vacation pay,sick pay, draws, incentive pay, bonuses, stock and stock options, equity, commissions, separation pay, any and all other forms of compensation orbenefits, attorney's fees, or other costs or sums. 7. Company Files, Documents and Other Property: By the close of business on the Termination Date, you will return to the Company all Companyproperty and materials in your possession, including but not limited to, cell phone, personal computers, laptops, iPAD, MiFI, intangible informationstored on diskettes, software programs and data compiled with the use of those programs, software passwords or codes, tangible copies of trade secrets andconfidential information, credit cards, telephone charge cards, manuals, building keys and passes, names and addresses of all Company customers andpotential customers, customer lists, customer contacts, sales information, memoranda, sales brochures, marketing materials, press clippings, business ormarketing plans, reports, projections, and any and all other information or property previously or currently held or used by you that is or was related toyour employment with the Company, including any such items located in your office in Utah (“Company Property”). You agree that if you discover anyother Company Property in your possession after the Termination Date, you will immediately return such materials to the Company. You represent thatyou will, after providing Company Property to Company, permanently delete and expunge all Company information, including Company proprietaryinformation without retaining any copy or reproduction in any form. 8. No Liability or Wrongdoing: Nothing in this Agreement, nor any of its terms and provisions, nor any of the negotiations or proceedingsconnected with it, constitutes, will be construed to constitute, will be offered in evidence as, received in evidence as and/or deemed to be evidence of anadmission of liability or wrongdoing by any and/or all of the Company Releasees, and any such liability or wrongdoing is hereby expressly denied byeach of the Company Releasees. 9. Future Conduct: (a) Confidentiality, Inventions Assignment, Non-Compete and Non-Solicitation Agreement: You confirm and reaffirm the existence andcontinued validity of the Confidentiality, Inventions Assignment, Non-Compete and Non-Solicitation Agreement (the “Non-Disclosure Agreement”)between you and the Company, which is incorporated herein by reference (a copy of which is enclosed herewith.) (b) Indemnification; Remedies: To the extent permitted by law, each party agrees to indemnify and hold the other party harmless from andagainst any and all loss, cost, damage, or expense, including, but not limited to, reasonable attorneys’ fees, incurred by the indemnified party arising outof any action at law or equity, or any other proceeding, to enforce any of the terms, covenants or conditions of the Agreement or due to a breach of thisAgreement by the indemnifying party.  (c) Non-disparagement: Except pursuant to a court order or as otherwise compelled by law, each party agrees that it will not directly orindirectly make or ratify any statement, public or private, oral or written, to any person that disparages, either professionally or personally, the other partyor Company Releasee or that is derogatory or untruthful in any material respect about the other party or any Company Releasee. (d) Confidentiality of this Agreement: Each party shall maintain confidentiality concerning this Agreement, including the substance, terms,existence and/or any discussions or negotiations relating to this Agreement. Each party agrees that it will not disclose these matters to anyone, in words orin substance, except: (a) to their respective attorneys, financial advisors, and, in the case of Dr. Wenstrup, immediate family members, provided that theyfirst agree to keep all such matters confidential; (b) to any taxing authority in connection with any requirement to provide information thereto; and (c) tothe extent required or allowed by law or to the extent necessary to enforce rights under this Agreement; provided however that if a party anticipates or isrequired to make disclosure pursuant to this subparagraph (c), each party shall provide notice to the other, in accordance with the notice provisions of thisAgreement, at least ten (10) days prior to such disclosure whenever possible, and where not possible, with as much advance notice as possible. Nothing in this Agreement shall prohibit or bar you from providing truthful testimony in any legal proceeding or in filing a complaint, orparticipating, cooperating, or communicating with any governmental agency or representative (including without limitation the Equal EmploymentOpportunity Commission (“EEOC”), any state or local fair employment practices agency, or the National Labor Relations Board (“NLRB”)), or frommaking any truthful disclosure required, authorized or permitted under law; provided however, that you acknowledge and agree that in providing suchtestimony, or making such disclosures, or filing, cooperating, participating, or communicating as provided herein, the consideration provided to you inthis Agreement shall be the sole relief provided to you for any claims that are released by you herein, and you will not be entitled to recover, and agree towaive, any monetary benefits or recovery against the Company in connection with any such testimony, disclosure, filing, or other such communicationyou offer/provide, without regard to who brought such action. 10. Representations and Governing Law: (a) This Agreement sets forth the complete and sole agreement between the parties and supersedes any and all other agreements orunderstandings, whether oral or written, except for the Non-Disclosure Agreement and the Stock Option Agreement, which shall remain in full force andeffect in accordance with their terms. This Agreement may not be changed, amended, modified, altered or rescinded except upon the express writtenconsent of both you and an authorized Company officer. Any waiver of any provision of this Agreement shall not constitute a waiver of any otherprovision of this Agreement unless expressly so indicated otherwise. Provided, however, if your full and general release of the Company and CompanyReleasees as outlined in Section 4 herein is found invalid, illegal, and/or unenforceable, you agree to provide the Company and Company Releasees a fulland general release that is not invalid, illegal, and/or unenforceable, without payment of additional consideration. The language of all parts of thisAgreement shall in all cases be construed as a whole according to its fair meaning and not strictly for or against any of the parties.  (b) This Agreement shall be deemed to be made and entered into in the Commonwealth of Massachusetts. This Agreement and any claimsarising out of this Agreement (or any other claims arising out of the relationship between the parties) shall be governed by and construed in accordancewith the laws of Massachusetts and shall in all respects be interpreted, enforced and governed under the internal and domestic laws of such State, withoutgiving effect to the principles of conflicts of laws of such State. Any claims or legal actions by one party against the other shall be commenced andmaintained in any state or federal court located in such State, and you hereby submit to the jurisdiction and venue of any such court. (c) You shall not assign this Agreement. The Company may assign this Agreement. The benefits of this Agreement shall inure to the successorsand assigns of the Company. (d) Except as otherwise specifically provided by this Agreement, if one or more of the provisions contained in this Agreement shall for anyreason be held to be excessively broad as to scope, activity, subject or otherwise so as to be unenforceable at law, such provision or provisions shall beconstrued by the appropriate judicial body by limiting or reducing it or them, so as to be enforceable to the maximum extent compatible with theapplicable law as it shall then appear. Furthermore, this Agreement is intended to be severable. Should any portion, term or provision of this SeparationAgreement be declared or determined by any court or arbitrator to be illegal, invalid or unenforceable, the validity of the remaining portions, terms andprovisions, and the application of such portion, term or provision in circumstances other than those as to which it is so declared illegal or unenforceable,shall not be affected thereby, and the illegal, invalid or unenforceable portion, term or provision shall be valid and enforceable to the fullest extentpermitted by applicable law. Provided however, that in the event the Release provision of this Agreement is found to be invalid, illegal, and/orunenforceable, you agree to provide the Company and Company Releasees with a full and General Release that is not invalid, illegal and/orunenforceable, without payment of additional consideration. The language of all parts of this Agreement shall be construed as a whole, according to itsfair meaning, and not strictly for or against either party. 11. Notice. Any notice under this Agreement shall be sent to you at 7750 Tall Oaks Drive, Park City, UT 84098 and to the Company, as follows: Elizabeth M. KeileySenior Vice President, General CounselOxford Immunotec USA, Inc.700 Nickerson Road, Suite 200Marlborough, MA 01752 This is an important legal document, accordingly, the Company advises you to consult with an attorney prior to executing this Agreement. In signing thisAgreement, you give assurance that you have had a full and reasonable opportunity to consider its terms; that you have read and understood all of thoseterms; and that your acceptance of this Agreement is freely and voluntarily given. 12. Effective Date: You may revoke this Agreement during the period of seven (7) days following its execution by you and this Agreement shall notbecome effective or enforceable, and no payments will be made pursuant to Section 2, until the revocation period has expired (the “Effective Date”). Thefirst payment made pursuant to Section 2 shall be made on or about March 29, 2019 and in accordance with the Company's regular payroll cyclethereafter. To revoke this Agreement, you must deliver a letter stating that you are revoking the Agreement to Elizabeth M. Keiley, SVP, General Counsel,Oxford Immunotec USA, Inc., 700 Nickerson Road, Marlborough, MA 01752 and such letter must be delivered before the close of business on the seventhday following your signature. 13. Compliance with Terms. Failure to insist on compliance with any term, covenant or condition contained in this Agreement shall not be deemeda waiver of that term, covenant or condition, nor shall any waiver or relinquishment of any right or power contained in this Agreement at any one time ormore times be deemed a waiver or relinquishment of any right or power at any other time or times.  If this Agreement correctly states the understanding and agreement we have reached please indicate your acceptance by signing below where indicated nolater than twenty one (21) days after you receive it. If this Agreement is not returned by such date, it shall be deemed to have expired. PLEASE READ CAREFULLY. THIS AGREEMENT CONTAINSA RELEASE OF KNOWN AND UNKNOWN CLAIMS. I, Richard Wenstrup, REPRESENT THAT I HAVE READ THE FOREGOING AGREEMENT, THAT I FULLY UNDERSTAND THE TERMS ANDCONDITIONS OF SUCH AGREEMENT AND THAT I AM VOLUNTARILY EXECUTING THE SAME. IN ENTERING INTO THIS AGREEMENT, I DONOT RELY ON ANY REPRESENTATION, PROMISE OR INDUCEMENT MADE BY THE COMPANY RELEASEES WITH THE EXCEPTION OF THECONSIDERATION DESCRIBED IN THIS DOCUMENT. ACCEPTED:AGREED: /s/: Richard Wenstrup OXFORD IMMUNOTEC USA, INC. Richard Wenstrup By:/s/: Peter Wrighton-Smith Date:3 March 2019 Its:Chief Executive Officer Date :8 March 2019  IF YOU DO NOT WISH TO USE THE 21-DAY PERIOD,PLEASE CAREFULLY REVIEW AND SIGN THIS DOCUMENT I, Richard Wenstrup, acknowledge that I was informed and understand that I have 21 days within which to consider the attached Agreement, havebeen advised of my right to consult with an attorney regarding such Agreement and have considered carefully every provision of the Agreement, and thatafter having engaged in those actions, I prefer to enter into the Agreement prior to the expiration of the 21-day period. Dated:3 March 2019 /s/: Richard Wenstrup Richard Wenstrup Exhibit 21.1 Oxford Immunotec Global PLC Subsidiaries Entity Jurisdiction of OrganizationOxford Immunotec Limited United KingdomOxford Immunotec USA, Inc. DelawareImmunetics, Inc. MassachusettsOxford Diagnostic Laboratories (UK) Limited United KingdomOxford Immunotec K.K. JapanBoulder Diagnostics Europe GmbH GermanyOxford Immunotec Asia Limited Hong KongOxford Immunotec (Shanghai) Medical Device Co. Ltd. Shanghai, China Exhibit 23.1 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in the following Registration Statements: (1)Registration Statement (Form S-3 Nos. 333-215236 and 333-200571) of Oxford Immunotec Global PLC, (2)Registration Statement (Form S-8 No. 333-193730) pertaining to the Oxford Immunotec Global PLC 2013 Share Incentive Plan, and (3)Registration Statement (Form S-8 No. 333-192582) pertaining to the Amended and Restated 2008 Stock Incentive Plan of Oxford ImmunotecGlobal PLC; of our reports dated March 27, 2019 with respect to the consolidated financial statements of Oxford Immunotec Global PLC and the effectiveness ofinternal control over financial reporting of Oxford Immunotec Global PLC included in this Annual Report (Form 10-K) of Oxford Immunotec Global PLCfor the year ended December 31, 2018. /s/ Ernst & Young LLP Boston, MassachusettsMarch 27, 2019 Exhibit 23.2 CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM We consent to the incorporation by reference in the following Registration Statements: (1)Registration Statement (Form S-3 Nos. 333-215236 and 333-200571) of Oxford Immunotec Global PLC, (2)Registration Statement (Form S-8 No. 333-193730) pertaining to the Oxford Immunotec Global PLC 2013 Share Incentive Plan, and (3)Registration Statement (Form S-8 No. 333-192582) pertaining to the Amended and Restated 2008 Stock Incentive Plan of Oxford ImmunotecGlobal PLC; of our report dated February 27, 2018, except for the effects of discontinued operations in Notes 1 and 19, as to which the date is March 27, 2019, withrespect to the consolidated balance sheet as of December 31, 2017 and the related consolidated statements of operations, other comprehensive loss,shareholders’ equity and cash flows of Oxford Immunotec Global PLC for the years ended December 31, 2017 and 2016 included in this Annual Report(Form 10-K) of Oxford Immunotec Global PLC for the year ended December 31, 2018. /s/ Ernst & Young LLP Reading, United Kingdom March 27, 2019 Exhibit 31.1 CERTIFICATIONI, Peter Wrighton-Smith, Ph.D., certify that: 1.I have reviewed this Annual Report on Form 10-K of Oxford Immunotec Global PLC; 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 thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial 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 defined inExchange 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)) for the registrant and have: a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period for 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 under oursupervision, 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; and d)disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materiallyaffect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’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 are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controlover financial reporting. Date: March 27, 2019 /s/ Peter Wrighton-Smith, Ph.D. Peter Wrighton-Smith, Ph.D.Chief Executive Officer and Director Exhibit 31.2 CERTIFICATIONI, Richard M. Altieri, certify that: 1.I have reviewed this Annual Report on Form 10-K of Oxford Immunotec Global PLC; 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 thisreport; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial 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 defined inExchange 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)) for the registrant and have: a)designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, toensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period for 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 under oursupervision, 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; and d)disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recentfiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materiallyaffect, the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’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 are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controlover financial reporting. Date: March 27, 2019 /s/ Richard M. Altieri Richard M. AltieriChief Financial Officer Exhibit 32 CERTIFICATION Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of theundersigned officers of Oxford Immunotec Global PLC, a company incorporated in England and Wales (the “Company”), does hereby certify, to suchofficer’s knowledge, that: The Annual Report for the year ended December 31, 2018 (the “Form 10-K”) of the Company fully complies with the requirements of Section 13(a) or15(d) of the Securities Exchange Act of 1934, as amended, and the information contained in the Form 10-K fairly presents, in all material respects, thefinancial condition and results of operations of the Company. Date: March 27, 2019 /s/ Peter Wrighton-Smith, Ph.D. Peter Wrighton-Smith, Ph.D.Chief Executive Officer and Director Date: March 27, 2019 /s/ Richard M. Altieri Richard M. AltieriChief Financial Officer This certification is being furnished and not filed, and shall not be incorporated into any document for any purpose, under the Securities Exchange Act of1934 or the Securities Act of 1933.

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