OpGen
Annual Report 2016

Plain-text annual report

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K (Mark one)☒☒ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2016☐☐TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from _______ to _______.Commission file number 001-37367 OPGEN, INC.(Exact name of registrant as specified in its charter) Delaware 06-1614015(State or other jurisdiction ofincorporation or organization) (I.R.S. EmployerIdentification No.) 708 Quince Orchard Road, Suite 205 Gaithersburg, Maryland 20878(Address of principal executive offices) (Zip Code)(240) 813-1260(Registrant’s telephone number, including area code)Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registeredCommon Stock, par value $0.01 per share The NASDAQ Capital MarketWarrants, exercisable for one share of common stock The NASDAQ Capital MarketSecurities registered pursuant to Section 12(g) of the Act:None 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 Section 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 1934 during the preceding12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted andposted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES ☒ NO ☐Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained,to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “largeaccelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one): Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☐ (Do not check if a smaller reporting company) Smaller reporting company ☒ Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Act). YES ☐ NO ☒The aggregate market value of the voting common stock held by non-affiliates of the registrant as of June 30, 2016, was $8.4 million (based upon the last reported sale priceof $1.52 per share on June 30, 2016, on The NASDAQ Capital Market).As of March 20, 2017, 27,377,490 shares of common stock of the registrant were outstanding.DOCUMENTS INCORPORATED BY REFERENCENone.  OPGEN, INC.ANNUAL REPORT ON FORM 10-KFor the Year Ended December 31, 2016TABLE OF CONTENTS PagePART I Item 1. Business 4Item 1A. Risk Factors 26Item 1B. Unresolved Staff Comments 47Item 2. Properties 47Item 3. Legal Proceedings 47Item 4. Mine Safety Disclosures 47 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 48Item 6. Selected Financial Data 49Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 49Item 7A. Quantitative and Qualitative Disclosures About Market Risk 56Item 8. Financial Statements and Supplementary Data 56Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 56Item 9A. Controls and Procedures 56Item 9B. Other Information 57 PART III Item 10. Directors, Executive Officers and Corporate Governance 58Item 11. Executive Compensation 62Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 70Item 13. Certain Relationships and Related Transactions, and Director Independence 71Item 14. Principal Accounting Fees and Services 73 PART IV Item 15. Exhibits and Financial Statement Schedules 74Item 16. Form 10-K Summary 74 Signatures 75 Consolidated Financial Statements F-1 2 INFORMATION REGARDING FORWARD-LOOKING STATEMENTSThis annual report on Form 10-K for the year ended December 31, 2016 (the “Annual Report”) and certain information incorporated herein by referencecontain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E ofthe Securities Exchange Act of 1934, as amended (the “Exchange Act”). In this Annual Report, we refer to OpGen, Inc. as the “Company,” “we,” “our” or“us.” All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financialposition, strategy and plans, and our expectations for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,”“continue,” “anticipate,” “design,” “intend,” “expect” or the negative version of these words and similar expressions are intended to identify forward-lookingstatements.We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect ourfinancial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-lookingstatements are subject to a number of risks, uncertainties and assumptions, including those described in Part I, Item 1A “Risk Factors.” In light of these risks,uncertainties and assumptions, the forward-looking events and circumstances included herein may not occur, and actual results could differ materially andadversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on theseforward-looking statements. Forward-looking statements include, but are not limited to, statements about: •our ability to finance our operations; •the commercialization of our current products, including our QuickFISH® and PNA FISH® diagnostic products for infectious diseases, ourAcuitas® MDRO test services and our Acuitas Lighthouse® bioinformatics services; •our ability to grow our customer base for our current products; •our liquidity and working capital requirements, including our cash requirements over the next 12 months and beyond; •anticipated trends and challenges in our business and the competition that we face; •the execution of our business plan and our growth strategy; •our expectations regarding the size of and growth in potential markets; •our opportunity to successfully enter into new collaborative agreements; •changes in laws or regulations applicable to our business, including potential regulation by the FDA; •our ability to develop and commercialize new products to address unmet needs in our industry, and the timing of commercialization; •compliance with the U.S. and international regulations applicable to our business; and •our expectations regarding future revenue and expenses.Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity,performance or achievements. In addition, neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. Any forward-looking statement made by us in this Annual Report speaks only as of the date on which it is made. We disclaim any duty toupdate any of these forward looking statements after the date of this Annual Report to confirm these statements to actual results or revised expectations.These factors should not be construed as exhaustive and should be read in conjunction with our other disclosures, including but not limited to the risk factorsdescribed in Part I, Item 1A of this Annual Report. Other risks may be described from time to time in our filings made under the securities laws. New risksemerge from time to time. It is not possible for our management to predict all risks. All forward-looking statements in this Annual Report speak only as of thedate made and are based on our current beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether as aresult of new information, future events or otherwise.NOTE REGARDING TRADEMARKSWe own various U.S. federal trademark registrations and applications and unregistered trademarks and servicemarks, including OpGen®, Acuitas®, AcuitasLighthouse® Argus®, AdvanDx®, QuickFISH®, and PNA FISH®. All other trademarks, servicemarks or trade names referred to in this Annual Report are theproperty of their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report are sometimes referred to without the ®and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicablelaw, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement orsponsorship of us by, any other companies, products or services.3 PART IItem 1. BusinessPlease refer to the Glossary at the end of this Business section for definitions or descriptions of scientific, diagnostic, healthcare and regulatory terms usedin this Annual Report.OverviewWe are a precision medicine company using molecular diagnostics and bioinformatics to help combat infectious disease. We are developing molecularinformation products and services to combat infectious disease in global healthcare settings, helping to guide clinicians with more rapid information aboutlife threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms. Our proprietaryDNA tests and bioinformatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimize patient caredecisions and protect the hospital biome through customized screening and surveillance products and services.Our molecular diagnostics and bioinformatics offerings combine our Acuitas® DNA tests, Acuitas Lighthouse® bioinformatics services and CLIA labservices for MDRO surveillance. We are working to deliver our products and services, some in development, to a global network of customers and partners.These include: •Our Acuitas DNA tests, which provide rapid microbial identification, and antibiotic resistance gene information. These products include theQuickFISH® family of FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures, the AcuitasMDRO Gene Test to detect, type, track, and trend antibiotic resistant organisms in real-time and our Acuitas Rapid Test in development. We areworking to provide actionable, precise diagnostic information powered by pathogen surveillance data collected through hospital screeningprograms and a network of hospital and public health laboratories globally. •Our Acuitas Lighthouse bioinformatics systems, which are cloud-based HIPAA compliant bioinformatics offerings that combine clinical labtest results with patient and hospital information and provide analytics to help manage MDROs in the hospital and patient care environment.These include our Acuitas Lighthouse informatics, which can be specific to a healthcare facility, public health department or collaborator, suchas a pharmaceutical company, and our Acuitas Lighthouse Knowledgebase, a proprietary data warehouse in development to include genomicdata matched with antibiotic susceptibility information for microbes and patient information from healthcare providers, in which we arebeginning to collect and store MDRO information from a variety of sources for use with our Acuitas Rapid Test in development.There is rising global concern about the profound health and macroeconomic consequences if the growing threat of antimicrobial resistance is not tackled.Drug resistant infections currently claim at least 50,000 lives each year in the United States and Europe alone, with many hundreds of thousands more dyingin other areas of the world. Recognizing this emerging threat, the White House issued a National Action Plan for Combating Antibiotic Resistance Bacteria inMarch 2015. The National Action Plan aims to achieve major reductions in the incidence of these urgent and serious threats and improvements in antibioticstewardship during the next five years. The 2016 U.S. government budget included approximately $1 billion to help combat drug resistant infections. Threekey areas have been highlighted for investment: rapid diagnostics, surveillance, and new antibiotics. We are focused in rapid diagnostics where our currenttests help identify microorganisms and determine their antibiotic resistance genes and susceptibility faster than conventional diagnostics. We are alsofocused on developing more rapid diagnostic tests to provide pathogen identification and antibiotic resistance information within one to three hours ofspecimen collection. Through the use of our Acuitas data warehouse we are working to provide antibiotic decision support tools to help physicians interpretand act on this information. A second area of our focus is surveillance of microbial infections and colonization with MDROs in the hospital environment.These products and services are designed to help enable effective response to resistant organisms and to help control MDRO transmission and outbreaks inthe hospital. We believe that the diagnostic paradigm for management of drug resistant infections is poised for change. In acute care settings, initial treatment today reliesheavily on initial use of broad spectrum antibiotics on an empiric basis. For example, it is common for patients to receive the antibiotic vancomycin fortreatment of potential Gram positive infections such as Staphylococcus and the antibiotic cefipime for treatment of potential Gram negative infections fromorganisms such as Escherichia coli, Klebsiella pneumoniae, or Pseudomonas. These powerful antibiotics are often prescribed without previous knowledge ofwhether the organism they are intended to treat is present. Current methods require 2-4 days to determine the organism identification and antibioticsusceptibility. During this period in advance of receiving the correct diagnosis, patients may often be over-treated or treated with an ineffective antibioticleading to potentially undesirable outcomes such as morbidity from expanded infection, drug resistance, and opportunistic infections. If the diagnosis is thatthe initial empiric antibiotic therapy was incorrect, a new therapy must be chosen which may result in poor clinical outcomes, additional length of stay, andincreased healthcare costs.4 Improved diagnostics for detection of resistant bacteria and characterization of resistance patterns will help healthcare providers make optimal treatmentdecisions earlier and assist public health officials in taking action to prevent and control disease. Improved and more rapid diagnostics will also helpdecrease unnecessary or inappropriate use of antibiotics. Optimal precision medicine tests for combatting infectious disease will provide diagnosticinformation in the first hours after presentation of the acutely ill patient to the healthcare facility in order to impact initial antibiotic selection decisions.Conventional microbiology methods have been largely unchanged, and we believe that it is unlikely that they will be adapted to provide rapid one to threehour diagnostic tests for high resolution microbial analysis. DNA analysis technology, such as our Acuitas DNA tests in development, which have thepotential to help revolutionize rapid diagnostics for microbiology. DNA tests are highly accurate and can be performed in just 30 minutes to an hour. OurFDA-cleared QuickFISH rapid pathogen identification tests are examples of such rapid detection technology; they currently provide rapid pathogen analysiswithin 30 minutes after a positive blood culture report. We are working on tests to accelerate such pathogen analysis to occur within one to three hours ofspecimen collection. In addition, DNA sequencing technology now makes it possible to sequence the entire genome of microbes for subsequent analysis,antibiotic selection decision making software, and microbe tracking.Our suite of DNA-based products and products in development are intended to provide actionable, precise diagnostics powered by microbial surveillancedata. The high resolution Acuitas DNA tests use multiplex PCR to help provide reliable and accurate detection of drug resistance. The QuickFISH tests arepowered by PNA technology and provide rapid pathogen identification, typically in less than 30 minutes from a positive blood culture result. The AcuitasMDRO Gene Test is used for determining if ICU patients are colonized with MDROs. Positive samples are confirmed using microbiological methods and theAcuitas Resistome Test for high resolution genotyping. Test results are maintained in the Acuitas Lighthouse data warehouse for subsequent interpretationby physicians and healthcare providers.We are developing a new disruptive testing paradigm that we believe could provide results in one to three hours from specimen collection and help addressmany of the current issues with testing for antibiotic resistance. We are developing a new high resolution Acuitas Rapid Test designed to detect the keyresistome profiles of Gram negative organisms. The product is anticipated to be used initially for research use only in infection control and clinicalresearch. Ultimately, following receipt of appropriate regulatory approvals, we anticipate the Acuitas Rapid Test will be used in the clinical setting toprovide pathogen and antibiotic resistance gene information to aid in decision making for patients with complicated urinary tract infections, complicatedpneumonia, and blood stream infections. We are also developing a smart cloud based clinical database that we are calling the Acuitas LighthouseKnowledgebase that will include critical infection control information and provide additional analysis of Acuitas resistance test results to provide additionalinsight to aid initial antibiotic selection and clinical decision making. Our proprietary Acuitas Lighthouse Knowledgebase distills large amounts of data intoone actionable profile. We believe our disruptive approach will be globally applicable and could be an important new weapon in the fight against drug-resistant bacteria. The figure below describes the potential workflow and anticipated results from our new testing approach. 5 Our StrategyWe are using our current product and service offerings, and will use our products in development to build a comprehensive precision medicine solutions forcombatting infectious diseases with a focus on developing diagnostic tests for rapid pathogen identification and genetic profiling, antibiotic resistanceanalysis and advanced bioinformatics to store and analyze MDRO and other infectious disease data for hospitals, out-patient settings and other healthcareproviders. We believe more rapid genetic identification methods will reduce morbidity from MDROs, reduce healthcare costs through reduced length of stay,and assist in the identification of targeted antibiotic therapy. Current conventional microbiology, largely unchanged in 50 years, requires one to two days forgrowth and phenotypic analysis and often leads to the use of broad spectrum antibiotic therapy in the early stages of infection. Our current QuickFISH andPNA FISH FDA-cleared, CE-marked diagnostic tests can accelerate accurate pathogen identification by one to three days when compared to conventionalmethods by providing identification of the pathogen within 30 to 90 minutes of positive blood culture results. We are working to: •Expand our rapid diagnostics product offerings through development of the Acuitas Rapid Test, with a goal of achieving one to three hourantibiotic resistance analysis from the time of specimen collection; •Grow our Acuitas Lighthouse data warehouse offerings for resistance and susceptibility data in a hospital, hospital system, or broadercommunity through the creation of the Acuitas Lighthouse Knowledgebase; •Continue development of our Acuitas Lighthouse informatics and decision-making software and work to install Acuitas Lighthouse access atall customer sites in the United States and globally who meet minimum test volume license requirements; •Accelerate the commercialization of our Acuitas Gene Tests and Acuitas Lighthouse informatics; •Expand our lab service offerings and capabilities through the supply of kits for use on our DNA probe assay platform and commerciallyavailable rapid diagnostic testing systems, develop additional MDRO DNA sequencing tests and informatics; •Partner with reference laboratories, government agencies, diagnostic companies and information technology providers to offer our AcuitasLighthouse informatics and Acuitas Lighthouse Knowledgebase on a global basis; and •Accelerate growth through strategic partnerships, which may include companies developing rapid diagnostic tests for MDROs, sponsoredresearch programs with governments and industry, and strategic acquisitions.We believe our products and services, including those in development, can be integrated into a MDRO and antibiotic single solution for assisting healthcareproviders to rapidly combat infectious diseases. By seeking to address institutional needs for informatics, genetic analysis and microbiologic testing, we areworking to establish a market leadership position in MDRO analysis. We are focused on developing products and services to help hospitals reduce hospitalacquired infection rates by helping to rapidly identify patients colonized with MDROs who should receive contact precautions, and helping to guideantibiotic therapy in a variety of healthcare settings.6 Molecular Information BusinessWe are working to build a unique and highly proprietary molecular information business. Our approach combines FDA-cleared and CE-marked rapiddiagnostics and CLIA lab-based MDRO surveillance tests with our Acuitas Lighthouse data warehouse. We are developing an integrated solution based on agenomic knowledgebase of drug resistant pathogens. Our approach involves sourcing thousands of pathogens from hospitals worldwide and completinggenomic analysis including DNA sequencing, drug susceptibility testing of each individual pathogen. These data are combined along with hospital patientdata and other information in our Acuitas Lighthouse Knowledgebase. We anticipate using this information and insights we derive from it to help power ourrapid diagnostic products, healthcare management solutions and new applications to support pharmaceutical companies. 2016 EventsBusiness InitiativesIn May 2016, OpGen and the District of Columbia Hospital Association (“DCHA”) announced the completion of the first city wide quantification of MDROs.The study was conducted with Washington D.C.’s public health departments to gauge the prevalence of the multidrug-resistant Gram-negative bacteria CREin healthcare facilities throughout the District of Columbia. The results revealed the prevalence of CRE and other CRO was 5.1% and 6.4%,respectively. The study also reported a wide range of variability across the 16 institutions tested providing direction for concentrated intervention.In July 2016, we completed the Intermountain Healthcare (“IHC”) Retrospective MDRO Health Outcome Study. The study was one of the largest of its kindever conducted in an integrated health system. 900,000 hospital admissions were evaluated over an eight-year period at IHC, including 22 hospitals andaffiliated clinics to help evaluate actual healthcare costs of MDRO and C. difficile infections and to provide proprietary data sets to help guide OpGencommercialization and R&D activities. The researchers found that a 222% increase was observed in the prevalence of C. difficile infections as well as a322% increase in ESBL (extended spectrum beta lactamase) positive organisms. The study documented total costs of hundreds of millions of dollars andaverage individual patient costs of between $25,000 and $80,000. Total costs are projected to double over the next seven years.In October 2016, we entered into a research collaboration with Merck Sharp & Dohme Corp., a wholly owned subsidiary of Merck Co. & Inc. (“Merck”) todevelop new rapid diagnostics and information technology products to help combat the threat of antimicrobial resistance. The companies will collaborate tosupport OpGen’s development of rapid DNA tests and a genomic knowledgebase of antibiotic-resistant pathogens for predicting antibiotic susceptibilitybased on test results. Under the terms of the agreement, Merck will provide access to its archive of over 200,000 bacterial pathogens gathered over the last 15years through the Study for Monitoring Antimicrobial Resistance Trends (“SMART”), one of the world’s largest surveillance studies of antimicrobialresistance supported by Merck in collaboration with International Health Management Associates (“IHMA”). OpGen will perform genomic analysis,microbiology testing for drug resistance, and incorporate this information into its Acuitas Lighthouse Knowledgebase and the development of rapid DNAtests such as the Acuitas Rapid Test in development. OpGen will initially perform molecular analyses on up to 10,000 pathogens to identify markers ofresistance to support rapid decision making using the Acuitas Lighthouse data warehouse, and7 to speed development of OpGen’s rapid diagnostic platforms. Merck will gain access to the high-resolution genotype data for the SMART isolates as well asaccess to Acuitas Lighthouse informatics to support internal research and development programs.FinancingsOn May 19, 2016 and June 27, 2016, the Company offered and sold units in a private offering to members of management and employees and to accreditedinvestors, including Merck Global Health Innovation Fund (“Merck GHI”) and jVen Capital, each unit consisting of either (i) one share of common stock anda detachable stock purchase warrant to purchase an additional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock and adetachable stock purchase warrant to purchase an additional 0.75 shares of common stock, at a price of $1.14 per unit. The total net proceeds to theCompany, after deducting offering commissions and expenses was $9.5 million. The Company is using the proceeds for working capital and generalcorporate purposes. Pursuant to the private offering the Company issued 6,744,127 shares of common stock, 2,309,428 shares of Series A non-votingconvertible preferred stock and stock purchase warrants to acquire an additional 6,790,169 shares of common stock. Each share of non-voting convertiblepreferred stock was convertible at the option of the holder in whole or in part and from time to time into one share of common stock, is entitled to dividendson as “as converted basis” when and if dividends are issued to common stockholders, and participates in liquidation on a pari passu basis with commonstockholders. Holders of the Series A non-voting convertible preferred stock subsequently converted all 2,309,428 shares of preferred stock into2,309,428 shares of common stock. The stock purchase warrants issued as part of the units are exercisable $1.3125 per share beginning 90 days after closingfor five years, expiring on May 18, 2021. On July 20, 2016, the Company’s registration statement on Form S-3, registering for resale by the holders of theshares of common stock acquired in the private offering was declared effective by the U.S. Securities and Exchange Commission (the “SEC”). In August 2016, the Company filed a shelf registration statement on Form S-3 registering $50 million of common stock for future offerings. The shelfregistration statement was declared effective by the SEC on September 9, 2016.On September 13, 2016, the Company entered into the Sales Agreement with Cowen and Company LLC (“Cowen”) pursuant to which the Company mayoffer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to anaggregate of $11.5 million. Pursuant to the Sales Agreement, Cowen may sell the shares of common stock by any method permitted by law deemed to be an"at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made bymeans of ordinary brokers' transactions on The NASDAQ Capital Market or otherwise at market prices prevailing at the time of sale, in block transactions, oras otherwise directed by the Company. The Company pays Cowen compensation equal to 3.0% of the gross proceeds from the sales of common stockpursuant to the terms of the Sales Agreement. As of December 31, 2016, the Company has sold an aggregate of approximately 3.6 million shares of itscommon stock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $4.4 million, and gross proceeds of$4.7 million. As of December 31, 2016, remaining availability under the at the market offering is $6.8 million. Subsequent to December 31, 2016, theCompany has sold an aggregate of approximately 2.1 million shares of its common stock under this at the market offering resulting in aggregate net proceedsto the Company of approximately $2.1 million, and gross proceeds of $2.2 million. Under the initial sales agreement, remaining availability under the at themarket offering is $4.6 million.Market OverviewAntibiotic Resistance – An Urgent Global IssueWe believe that antimicrobial resistance is an urgent global healthcare issue. MDROs have been prioritized as an urgent national and global threat by theCDC, the President of the United States and the WHO. In September 2014, The White House issued a National Strategy for combating antibiotic-resistantbacteria. The strategy calls for the strengthening of surveillance efforts to combat resistance, the development and use of innovative diagnostic tests foridentification and characterization of resistant bacteria and antibiotic stewardship and development.The CDC estimates that in the United States more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000dying as a result. Antibiotic-resistant infections add considerable but often avoidable costs to the U.S. healthcare system. In most cases, these infectionsrequire prolonged and/or costlier treatments, extended hospital stays, additional doctor visits and healthcare facilities use, and result in greater disability anddeath compared with infections that are treatable with antibiotics. Estimates for the total economic cost to the U.S. economy range between $20 and $35billion annually. As described in a December 2014 report issued by the Review on Antimicrobial Resistance commissioned by the U.K. Prime Minister titled“Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations,” 300 million people are expected to die prematurely because of drugresistance over the next 35 years, which could result in $60 to $100 trillion worth of economic output if the problem of antimicrobial drug resistance is notresolved.8 In February 2017, the WHO published its first ever list of antibiotic-resistant “priority pathogens” – a catalog of 12 families of bacteria that pose the greatestthreat to human health. The list was drawn up in a bid to guide and promote research and development (“R&D”) of new antibiotics, as part of WHO’s effortsto address growing global resistance to antimicrobial medicines. The list highlights the threat of gram-negative bacteria that are resistant to multipleantibiotics. These bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material that allows other bacteria tobecome drug-resistant as well. The most critical group of all includes multidrug resistant bacteria that pose a particular threat in hospitals, nursing homes, andamong patients whose care requires devices such as ventilators and blood catheters. They include Acinetobacter, Pseudomonas and variousEnterobacteriaceae (including Klebsiella, E. coli, Serratia, and Proteus). They can cause severe and often deadly infections such as bloodstream infectionsand pneumonia. These bacteria have become resistant to a large number of antibiotics, including carbapenems and third generation cephalosporins – the bestavailable for treating multi-drug resistant bacteria.Another emerging global threat are carbapenem-resistant enterobacteriaceae (“CREs”) that are either difficult to treat or wholly untreatable. According toformer CDC Director Dr. Tom Frieden, CREs are a “nightmare bacteria.” The strongest antibiotics do not work and patients are left with potentiallyuntreatable infections with mortality rates ranging between 40% and 80%. CRE strains are transmitted easily in healthcare settings from patients withasymptomatic intestinal colonization, and the CRE strains have the potential to spread antibiotic resistance through plasmid transfer to other bacterialspecies, including common human flora and potential pathogens such as Escherichia coli. The CDC has called for urgent action to combat the threat of CREbacteria. Core prevention measures recommended by the CDC for all acute and long-term care facilities include: contact precautions for all patients who arecolonized or infected with CRE, single patient room housing or cohorting, laboratory notification procedures, antibiotic stewardship and screening toidentify unrecognized CRE colonization in patients admitted to high risk settings such as ICUs, long-term acute care units or facilities, or epidemiologicallylinked contacts.Emergence of Superbugs and Lack of Treatment OptionsOver the last decade multidrug-resistant Gram negative bacteria, frequently referred to as Superbugs, have been implicated in severe HAIs, and theiroccurrence has increased steadily. For example, Klebsiella pneumoniae, or K. pneumoniae, is responsible for roughly 15% of Gram-negative infections inhospital intensive care units. Infections caused by KPC strains have few treatment options and are associated with a mortality rate upwards of 50%.Exacerbating the problems associated with the emergence of these highly resistant KPC strains is their propensity to cause outbreaks in healthcareinstitutions. These pathogens persist both in the flora of hospitalized patients and in the hospital environment, and they have the capacity to silentlycolonize patients or hospital personnel by establishing residence in the gastrointestinal tract without causing any signs of infection. Individuals can besilently colonized or become asymptomatic carriers for long periods of time, with detection of these carriers often proving difficult. These silent carriers act asreservoirs for continued transmission, which makes subsequent spread difficult to control and outbreaks difficult to stop. In addition, KPC strains can survivefor several hours on the hands of hospital personnel, which likely facilitates spread from patient to patient. Effective control of KPC outbreaks requires adetailed understanding of how transmission occurs, but current technologies do not allow healthcare providers to routinely perform these investigations on atimely basis.The lack of currently available treatment options and scarcity of new treatment options in development are compounding the emerging Superbug problem. Ithas been close to 30 years since a new class of antibiotics was developed and successfully introduced. As a result, we believe that rapid, accurateidentification of the pathogen and its genetic make-up, screening, infection control and antibiotic stewardship have become one of the most powerfulweapons in the fight to contain this threat.Based on industry analyses, we believe the global HAI market is a $2 billion dollar market with the molecular diagnostic segment representing a fast growingsegment of such market with multiple high acuity patients and significant infectious sites, including urinary tract infections, surgical site infections,pneumonia, bloodstream infections.The initial focus of our MDRO surveillance business is the U.S. hospital market where there are approximately 5,000 hospitals and a potential marketopportunity of six million tests annually for our Acuitas MDRO Gene Test. According to statistics issued by AHA Hospitals Statistics in 2011, there are 1,395acute care hospitals in the United States with 200 or more beds that are candidates for weekly screening of the approximately 20% of patients who are at highrisk for MDRO colonization or infection. There are also 290 long term acute care hospitals where we believe all patients are candidates for bi-weeklyscreening. We believe the high-risk MDRO testing market opportunity in the United States is approximately $400 million. The trend toward consolidatedhealth systems is resulting in the combination of small and mid-sized hospitals into large health systems that are the initial targets for our test and informaticsproducts. A typical large health system could have more than $4 billion in annual revenue, a central hospital with more than 400 beds and 6-8 smallerhospitals and long-term care facilities. These large health systems have started to centralize their microbiology lab testing, making them an attractive targetmarket for us.9 The trend towards forming ACOs is expected to increase the focus on reducing length of stay and the overall cost of hospital procedures. Since HAIs result inincreased costs of approximately $24,000 per affected patient, we anticipate ACOs will be particularly receptive to our MDRO management offerings.According to Diagnostic Kit – second edition, March 2014 by Cowen & Co., the MRSA surveillance testing market and C. difficile testing market in theUnited States are approximately $300 million and $150 million, respectively. ProductsOur current product offerings include our QuickFISH and PNA FISH products, which are FDA-cleared, CE-marked in vitro diagnostic (“IVD”) tests designedto rapidly identify antimicrobial resistant pathogens significantly earlier than currently available conventional methods, our Acuitas MDRO Gene Test,Acuitas CR Elite Test and Acuitas Resistome Test, each a CLIA lab-based test that provides a profile of MDRO resistant genes for surveillance and responseto outbreaks, and our Acuitas Lighthouse informatics.FISH ProductsWe have commercialized 15 QuickFISH, PNA FISH and XpressFISH diagnostic test products in the United States and Europe for the identification of variousinfectious pathogens. The pathogens identified and differentiated by our FISH products are: QuickFISHPNA FISHXpressFISHStaphylococcusStaphylococcusMRSAEnterococcusEnterococcusMSSAGram-negative bacteriaGram-negative bacteria Gram –positive bacteriaGram-positive bacteria CandidaCandida Our FISH products can provide pathogen identification and differentiation within 20 to 90 minutes of positive blood culture results. Differentiation of thepathogen, such as, for example differentiating a methicillin resistant Staphylococcus aureus (“MRSA”) infection from a methicillin susceptibleStaphylococcus aureus (“MSSA”) infection provides actionable information that can be used by the healthcare provider to determine appropriate antibiotictherapy.We currently have approximately 100 U.S. hospital customers purchasing our FISH products, and sell our FISH products to hospitals in 10 countries withantibiotic stewardship programs. Our hospital customers include academic medical centers, tertiary care hospitals and community hospitals.An example of the usefulness of our QuickFISH products at Winter Haven Hospital in Florida was described in a recent publication “The Impact ofImplementation of Rapid QuickFISH Testing for Detection of Coagulase Negative Staphylococci at a Community-Based Hospital,” American Journal ofClinical Pathology, January 2016. In such case study our QuickFISH products demonstrated clinical utility and cost effectiveness in the more rapididentification and differentiation of staph-infected patients which resulted in a 90% reduction in pathogen identification (1.4 hours as compared to 17.2hours from a positive blood culture), decreased utilization of Vancomycin antibiotic therapy, a 30% reduction in length of stay and annual savings ofapproximately $764,000.10 Other Acuitas ProductsOur high resolution DNA tests are marketed under the Acuitas trade name. We have developed Acuitas DNA tests for use in our CLIA lab such as the AcuitasMDRO Gene Test and we are developing a rapid Acuitas DNA test for use in hospital laboratories that will combine rapid pathogen identification anddetection of antibiotic resistance genes. •Our Acuitas MDRO Gene Test is, to our knowledge, the first CLIA lab-based test able to provide information regarding the presence of tenMDRO resistance genes from one patient specimen. The ten drug-resistant genes identified by our Acuitas MDRO Gene Test are associatedwith CRE, ESBL and VRE organisms, and are gastrointestinal organisms frequently associated with antibiotic-resistant infections. The testresults can be used by healthcare providers to identify patients colonized with organisms expressing the drug-resistant genes or who areactively infected. •Our Acuitas CR Elite Test adds the ability for the healthcare provider to order a microbiology culture screen to be performed from the samespecimen sent for our Acuitas MDRO Gene Test, thereby providing additional information about the organism(s) associated with an activeinfection, as well as an antibiotic susceptibility profile for such organism(s). •Our Acuitas Resistome Test, launched in the second quarter of 2015, is a more comprehensive MDRO molecular test which detects 49 genescovering over 900 subtypes associated with antibiotic resistance. The test includes additional resistance genes for carbapenemases, ESBLs andAmpC genes, in replacement of the vancomycin resistant genes found in the Acuitas MDRO Gene Test. We believe the AmpC targets of theAcuitas Resistome Test are more specific for Gram-negative bacteria, thereby strengthening the coverage provided by our Acuitas ResistomeTest to detect resistance genes found in Klebsiella pneumoniae, Escherichia coli, Acinetobacter baumannii, Pseudomonas aeruginosa,Enterobacter cloacae, and Citrobacter freundii. We use Acuitas Resistome Test results for Acuitas Lighthouse profiling of specimens collectedin hospitals and clinical isolates from infected patients. Information from our Acuitas Resistome Test provides additional gene detectioninformation to supplement our Acuitas MDRO Gene Test. Acuitas Resistome Test results can be used in conjunction with the Acuitas CR EliteTest to provide high resolution Acuitas Lighthouse profiles. Our goal is to provide DNA test-based Acuitas Lighthouse profiles, within 24hours of sample receipt, and, using the Acuitas CR Elite Test to supplement our Acuitas Lighthouse profiles, with biologically derived,phenotypic antibiotic susceptibility data within 84 hours. We anticipate improving the accuracy, over time, of our Acuitas Resistome Test byperforming DNA sequence analysis of microbial isolates within our Acuitas Lighthouse data warehouse. We believe our menu of genotypic andphenotypic tests along with our Acuitas Lighthouse bioinformatics platform profiles, will enable better surveillance and epidemiology,improved infection control practices, improved antibiotic stewardship and individualized patient care, as well as help to facilitate outbreakdetection and response in healthcare settings. We also anticipate combining tests for infectious diseases such as C. difficile, MRSA and othersto provide enhanced MDRO screening and patient management offerings.See below for information about the Acuitas products in development.Acuitas LighthouseOur Acuitas Lighthouse bioinformatics platform enables proactive MDRO management to prevent in-hospital transmission events and to help improvepatient outcomes. Using our Acuitas Lighthouse informatics, launched in December 2015, we offer trend analysis of patient specific data, data specific toindividual hospital facilities and health systems, which can be provided safely and confidentially to healthcare providers. Our Acuitas Lighthouse’s dynamicprofiling incorporates identity, phenotype and MDRO gene presence and assigns unique microbe identifiers, or Acuitas Lighthouse informatics profiles,based on MDRO gene composition, and antibiotic susceptibility, or AST, data. We believe our Acuitas Lighthouse profiling will provide a comprehensivediagnostic tracking tool for MDRO infections in the hospital setting. It is based on our CLIA- and HIPAA-compliant LIMS database system. We havedeveloped a web-based portal to allow our customers access to LIMS-based lab reports and Acuitas Lighthouse data reports.We are also focused on further developing Acuitas Lighthouse into the Acuitas Lighthouse Knowledgebase, to provide an evergreen database forcomprehensive testing and bioinformatics analysis to help guide antibiotic therapy decision making with continual global pathogen data from our CLIA laband hospital customers, with such data to be used to: •assist in accelerating more rapid diagnosis with improved molecular susceptibility data; •provide MDRO screening and surveillance capabilities to hospitals to identify pathogen and resistance profiles; and •potentially accelerate new antibiotic development as the data are used to reveal genetic resistance patterns to direct drug discovery.11 During 2016 we completed initial development of our genomic discovery engine including custom genotyping and DNA sequencing tests. We completeddevelopment of the informatics infrastructure including the data warehouse and portal to support large-scale pathogen testing for the Acuitas LighthouseKnowledgebase.Other ProductsPrior to our shift in focus to developing and commercializing our MDRO products, OpGen had developed and commercialized the Argus® Whole GenomeMapping System, MapIt® Services and MapSolver™ bioinformatics products and services. Such products and services were sold to academic, public healthand corporate customers to allow them to perform Whole Genome Mapping and analysis of microbial, plant, animal and human genomes for life sciencesapplications. We have more than ten years of experience mapping microbial genomes. Our customers for these products include government and publichealth agencies such as the CDC, FDA, USDA and biodefense organizations, who use the Argus and MapSolver products in research and development, foodsafety and public health settings. In 2016 we ceased production of our Whole Genome Mapping products and notified our customers that we would no longersupport these products and services. In September 2013, we entered into a technology development agreement with Hitachi High‑Technologies Corporation (“Hitachi”) to commercialize ourWhole Genome Mapping technology for mapping, assembly and analysis of human DNA. Under that agreement we developed cloud-based human genomemap assembly capabilities. The technology development agreement ended in December 2015; there was no further activity under this agreement in 2016.In June 2016, we entered into a license agreement with Hitachi, pursuant to which we resolved various matters with respect to previously deliveredmilestones under the technology development agreement and provided a non-exclusive development license and a commercial products license to ourWhole Genome Mapping technology. The license agreement grants Hitachi designated development and commercialization rights. We are not an activeparticipant with Hitachi under the license agreement. During the year ended December 31, 2016, we recognized $137,603 of revenue related to the licenseagreement.Research and DevelopmentFor the years ended December 31, 2016 and 2015, our research and development expenses were $8.6 million and $6.0 million, respectively. We intend tocontinue to invest in the development of additional Acuitas gene tests, our Acuitas Lighthouse bioinformatics platform, and our QuickFISH rapididentification tests. Our current focus is on completing the development of our product offerings to provide actionable, precise diagnostics powered by ourAcuitas Lighthouse Knowledgebase for rapid diagnostics of pathogens, determination of the appropriate antibiotics to treat the infection and accumulationof actionable surveillance data to provide information useful for monitoring and controlling outbreaks and promoting antibiotic stewardship.Our ongoing research and development efforts include: •Development of the Acuitas Rapid Test, capable of providing genetic resistance information for up to 150 drug resistance genes in one to threehours from specimen collection, and a cloud-based Acuitas Lighthouse Knowledgebase for interpretation of test results and clinical decisionmaking support tools to help select appropriate antibiotic therapies; •Development of more rapid molecular diagnostic products to achieve actionable pathogen identification and differentiation in the first fewhours of presentation or symptoms; •Automating our QuickFISH products through digital imaging and analysis, new formats requiring less hands on time to process samples,multiplex formats that allow for testing of a broader range of microorganisms; •Continued investments in our Acuitas Lighthouse bioinformatics platform, focused on (i) data warehouse and portal for MDRO data and (ii)antibiotic analysis; •Further development of our Acuitas MDRO Gene Test, Acuitas Resistome Test and DNA sequencing; and •Converting our CLIA lab-based products to IVD kits that can be sold, upon receipt of FDA clearance and other approvals, directly to ourcustomers and to other clinical reference laboratories.12 Our ongoing Acuitas Rapid Test research and development programs and their stage of development are provided below. During 2016 we completed the initial development of our genomic discovery engine including custom genotyping and DNA sequencing tests. Wecompleted development of the information infrastructure including the Acuitas Lighthouse data warehouse and portal to support large-scale pathogen testingfor the Acuitas Lighthouse Knowledgebase. As an important component of this, in October 2016, we entered into a research collaboration with Merck todevelop new rapid diagnostics and information technology products to help combat the threat of antimicrobial resistance. For more information, please seethe description of this research collaboration above under the heading “2016 Events – Business Initiatives.”Sales and MarketingWe currently sell and market our products and services in the United States through a 12 person sales and marketing organization including direct salesprofessionals and a dedicated marketing support organization. Internationally, we sell our products through a network of distributors in 16 countries. Weoperate a subsidiary in Denmark that provides support for our European customers and to distributors in other parts of the world. We are involved in pilotprograms in approximately 10 countries to demonstrate the clinical and cost effectiveness of our FISH products. We are working to expand our market reachby entering into strategic co-marketing relationships with larger diagnostic and pharmaceutical companies and by expanding our network of distributorsglobally.Our strategic focus is on selling to health systems and larger healthcare ecosystems such as individual cities or regions. The collaboration with IntermountainHealthcare in Utah and the DC-HARP study in Washington, DC are examples of company initiatives to deploy its technology across multi-hospitalhealthcare settings. We are working to expand this successful initial project to a funded pilot implementation across multiple healthcare facilities in the city.For more information, please see the description of these strategic initiatives above under the heading “2016 Events – Business Initiatives.”We operate in one segment. Substantially all of our operations are in the United States. Total revenues from customers for the years ended December 31, 2016and 2015 were $4.0 million and $3.2 million, respectively. Net loss for the years ended December 31, 2016 and 2015 was $19.2 million and $17.4 million,respectively. Total assets at December 31, 2016 and 2015 were $9.0 million and $13.8 million, respectively.No individual customer represented in excess of 10% of revenues for the year ended December 31, 2016. For the year ended December 31, 2015, revenueearned from Hitachi represented 11% of total revenues.We anticipate that our direct sales organization, working in conjunction with our regional and health system high-level cooperation efforts, will sell andsupport our genomic diagnostic products, including MDRO surveillance and rapid diagnostics, and our Acuitas13 Lighthouse informatics offerings. In the United States, we anticipate that the Acuitas Rapid Test will become a lead product. As we work to gain appropriateregulatory approvals for this new product we plan to conduct clinical trial evaluations to document test performance and potential improved healthcareoutcomes and reduced costs. Each testing site is anticipated to have access to our MDRO surveillance CLIA lab services and our Acuitas LighthouseKnowledgebase.CompetitionWe believe we are currently the only company developing a molecular information business focused on leading a transformation in microbiology andinfectious disease through precision medicine products and services that combine genomic data and bioinformatics. Our approach combines proprietary DNAtests developed in our CLIA laboratory, FDA-cleared and CE-marked rapid diagnostics, and our Acuitas Lighthouse bioinformatics and data warehouseofferings. Our competitors include rapid diagnostic testing and traditional microbiology companies, commercial laboratories, information technologycompanies, and hospital laboratories who may internally develop testing capabilities. Principal competitive factors in our target market include:organizational size, scale, and breadth of product offerings; rapidity of test results; quality and strength of clinical and analytical validation data andconfidence in diagnostic results; cost effectiveness; ease of use; and regulatory approval status.Our principal competition comes from traditional methods used by healthcare providers to diagnose and screen for MDROs and from other moleculardiagnostic companies creating screening and diagnostic products such as Cepheid, Becton-Dickinson, bioMérieux, Accelerate Diagnostics, T2 BiosystemsGenMark and Nanosphere. We believe our focus on identifying antibiotic-resistant genes, rather than primarily organisms, the genes and associated diseasesincluded in our gene tests, and our Acuitas Lighthouse bioinformatics offerings distinguish us from such competitors.We also face competition from commercial laboratories, such as Bio-Reference Laboratories, Inc., Laboratory Corporation of America Holdings, QuestDiagnostics Incorporated and EuroFins, which have strong infrastructure to support the commercialization of diagnostic services.Competitors may develop their own versions of our product offerings in countries where we do not have patents or where our intellectual property rights arenot recognized.Many of our potential competitors have widespread brand recognition and substantially greater financial, technical, research and development and sellingand marketing capabilities than we do. Others may develop products with prices lower than ours that could be viewed by hospitals, physicians and payers asfunctionally equivalent to our products and services, or offer products and services at prices designed to promote market penetration, which could force us tolower our list prices and affect our ability to achieve profitability. If we are unable to change clinical practice in a meaningful way or compete successfullyagainst current and future competitors, we may be unable to increase market acceptance and sales of our products, which could prevent us from increasing ourrevenue or achieving profitability and could cause our stock price to decline.Laboratory OperationsOur laboratory operations are headquartered at our CLIA-certified laboratory in Gaithersburg, Maryland, where we perform all Acuitas testing. Samples aretransported to the laboratory by FedEx or by courier. Once received, samples are assessed for acceptability, accessioned into our LIMS, prepared forprocessing and analyzed with traditional microbiology culture methods or using molecular testing instrumentation. Laboratory test data is housed in aproprietary LIMS database that is CLIA laboratory compliant. Customers access CLIA laboratory test results through individual PDF test reports and throughour Acuitas Lighthouse informatics. Our laboratory also performs testing for research and development purposes and for both the creation and ongoingmaintenance of our Acuitas Lighthouse data warehouse.We believe we have sufficient laboratory capacity to perform Acuitas testing for at least the next 24 months.ManufacturingWe manufacture our FDA-cleared and CE-marked PNA FISH and QuickFISH products in our Woburn, Massachusetts facility. We are currently operating thisfacility under a five-year lease. Specialty reagents for our CLIA laboratory are manufactured at our Gaithersburg, Maryland facility.Manufacturing of our FDA-cleared products is performed under the current Good Manufacturing Practices - Quality System Regulation as required by theFDA for the manufacture of IVD labeled products. These regulations carefully control the manufacture, testing and release of IVD products as well as rawmaterial receipt and control. We also have ongoing postmarket vigilance responsibilities under FDA regulations, and are subject to periodic inspections bythe FDA to determine compliance with the FDA’s14 requirements, including primarily the quality system regulations and medical device reporting regulations. The results of these inspections can includeinspectional observations on FDA’s Form 483, warning letters, or other forms of enforcement. Our Woburn, Massachusetts facility was inspected by the FDAin 2015. Following such inspection, the FDA issued a report of its findings and observations, typically referred to as “Form 483 observations," primarilyrelated to our quality systems and testing policies and documentation. We have responded, or intend to respond, to all inspection observations within therequired timeframe and are working with the FDA’s Office of Compliance to satisfy the identified deficiencies.Seasonality of BusinessWe do not believe our business is subject to seasonality. However, our business can be subject to and affected by the business practices of our businesspartners. To the extent that the availability of inventory or materials from or development practices of our partners is seasonal, our sales may be subject tofluctuations quarter to quarter or year over year.Quality AssuranceOur quality assurance function oversees the quality of our laboratory and our FDA-cleared and CE-marked diagnostic products as well as the quality systemsused in research and development, client services, billing operations and sales and marketing. We have established a quality assurance system across ourentire business, including implementation and maintenance, document control, supplier qualification, corrective or preventive actions, oversight, andemployee training processes. We monitor and seek to improve our quality over time in compliance with all applicable regulations.Raw Materials and SuppliersWe procure reagents, equipment, chips and other materials we use to perform our Acuitas MDRO Gene Test from sole suppliers such as Fluidigm Corporation.We purchase the PNA probes, glass slides and specialty consumables for our QuickFISH products from third party manufacturers who have long lead timesand who manufacture several of these products for us on a sole source basis. We also purchase our collection kits from sole-source suppliers. Some of theseitems are unique to these suppliers and vendors. While we have developed alternative sourcing strategies for these materials and vendors, we cannot becertain whether these strategies will be effective or whether alternative sources will be available when we need them. If these suppliers can no longer provideus with the materials we need to perform our Acuitas MDRO Gene Test or manufacture our QuickFISH products, if the materials do not meet our qualityspecifications, or if we cannot obtain acceptable substitute materials, our business would be negatively affected.Payments and ReimbursementOur Acuitas MDRO test products, our Acuitas Lighthouse informatics and our QuickFISH tests are, and other future products and services will be, sold tohospitals and public health organizations on a fee-for-service basis. When hospital and health system clients purchase our QuickFISH tests we bill themdirectly for the purchase of test kits and consumables. Hospitals that purchase MDRO services from our CLIA laboratory are billed on a per test basis.Currently, we provide access to our Acuitas Lighthouse informatics. The portal capability is provided to our test customers who have sufficient test volume aspart of our MDRO test offerings.In the future, we envision selling our Acuitas Lighthouse Knowledgebase to health systems, hospitals and long-term care facilities under capitated, flat-ratecontracts. Health systems and hospitals absorb the costs of extended stay from HAIs and poor treatment outcomes. For healthcare providers to support the useof our tests and services, OpGen needs to demonstrate improved outcomes and reduced costs. Various studies have documented increased hospital stays of sixdays or more for patients infected with MDROs, resulting in increased costs of $25,000 to $82,000 per infected patient. Determining if an infection ishospital-acquired or was originally obtained from another source is an important issue for hospitals. We believe our tests may help adjudicate paymentfavorably for hospitals. Isolation procedures are also costly to hospitals, so it is critical that isolation/de-isolation decisions are made accurately. Two recentstudies documented a daily extra cost of approximately $101 for contact precaution equipment and approximately $57 for nursing time and contactprecaution supplies for each infected patient. In addition to costs to individual hospitals, estimates of the economic costs of antibiotic resistance to the U.S.economy range from $20 billion to $35 billion annually.Our marketing strategy focuses on the rapid turn-around time of our Acuitas MDRO and QuickFISH test results and the panel of results available from onepatient sample. We believe the combination of our Acuitas MDRO test products, including QuickFISH, and our Acuitas Lighthouse informatics differentiatesus in the marketplace by offering a single sample process for identification and management of MDROs. Our approach can deliver a number of benefits tohealthcare organizations including: (1) reduced lengths of stays; (2) cost savings and improved patient outcomes; and (3) avoidance of penalties by third-party payers for HAIs.We employ diverse marketing programs to inform key stakeholders of the value of our products and services in order to drive adoption. As part of ourmarketing strategy, we educate hospitals, other healthcare institutions, and healthcare professionals about our15 value proposition. We intend to expand our marketing efforts using proceeds from this offering to increase these activities by expanding our sales andmarketing efforts to microbiology and infection control professionals and hospital executives. We anticipate supporting efforts to advocate for expandedMDRO hospital surveillance, legislation at the state and federal level to encourage best practices for MDRO surveillance, and clinical practice guidelines.Finally, our website serves as a portal for educational material for hospitals, healthcare professionals and patients.Third-Party PayersWe do not currently rely on any third-party payers for payment or reimbursement to us for our Acuitas MDRO or QuickFISH test products. Although we donot anticipate seeking direct reimbursement to us, we do believe that Federal healthcare programs and other third-party payers may, in the future, reimbursehospitals for implementing institution-wide surveillance, infection control and antibiotic stewardship programs. Our management team has experienceseeking reimbursement from Federal healthcare programs and other third-party payers, and would work to: •Meet the evidence standards necessary to be consistent with leading clinical guidelines. We believe demonstrating that our products andservices meet leading clinical practice guidelines plays a critical role in payers’ coverage decisions; •Engage reimbursement specialists to ensure the payor outreach strategy reacts to and anticipates the changing needs of our customer base. Acustomer service team would be an integral part of our reimbursement strategy, working with hospitals to navigate the claims process; •Cultivate a network of key opinion leaders. Key opinion leaders are able to influence clinical practice by publishing research and determiningwhether new tests should be integrated into practice guidelines. We would collaborate with key opinion leaders early in the developmentprocess to ensure our clinical studies are designed and executed in a way that clearly demonstrates the benefits of our tests to physicians andpayers; and •Compile a library of peer-reviewed studies that demonstrate that our Acuitas MDRO test products are effective, accurate and faster than currentmethods.Intellectual PropertyIn order to remain competitive, we must develop and maintain protection of the proprietary aspects of our technologies. To that end, we rely on acombination of patents, copyrights and trademarks, as well as contracts, such as confidentiality, invention assignment and licensing agreements. We also relyupon trade secret laws to protect unpatented know-how and continuing technological innovation. In addition, we have what we consider to be reasonablesecurity measures in place to maintain confidentiality. Our intellectual property strategy is intended to develop and maintain our competitive position.As of December 31, 2016, we had total license or ownership rights to 172 patents, including 12 pending United States non-provisional patent applications,and 68 issued United States patents. More specifically, as of December 31, 2016, related to our FISH products, we had license or ownership rights to 99patents, including 1 pending United States non-provisional patent applications, and 45 issued United States patents. These issued patents began to expire inMarch 2017 and will be fully expired by January 2029. As of December 31, 2016, related to our Acuitas products, we had license or ownership rights to 22patents, including 4 pending United States non-provisional patent applications and no issued United States patents. As of December 31, 2016, related to ourother products, we had license or ownership rights to 51 patents, including 7 pending United States non-provisional patent applications, and 23 issuedUnited States patents related to our other products. These issued patents begin to expire in April 2017 and will be fully expired by January 2032.We intend to file additional patent applications in the United States and abroad to strengthen our intellectual property rights; however, our patentapplications (including the patent applications listed above) may not result in issued patents in a timely fashion or at all, and we cannot assure investors thatany patents that have issued or might issue will protect our technology.We require all employees and technical consultants working for us to execute confidentiality agreements, which provide that all confidential informationreceived by them during the course of the employment, consulting or business relationship be kept confidential, except in specified circumstances. Ouragreements with our research employees provide that all inventions, discoveries and other types of intellectual property, whether or not patentable orcopyrightable, conceived by the individual while he or she is employed by us are assigned to us. We cannot provide any assurance, however, that employeesand consultants will abide by the confidentiality or assignment terms of these agreements. Despite measures taken to protect our intellectual property,unauthorized parties might copy aspects of our technology or obtain and use information that we regard as proprietary.16 RegulationThe following is a summary of the regulations materially affecting our business and operations.Clinical Laboratory Improvement Amendments of 1988As a clinical reference laboratory, we are required to hold certain Federal, state and local licenses, certifications and permits to conduct our business. UnderCLIA, we are required to hold a certificate applicable to the type of laboratory examinations we perform and to comply with standards covering personnel,facilities administration, quality systems and proficiency testing.We have a current Certificate of Compliance under CLIA and a Medical Laboratory Permit from the State of Maryland to perform clinical testing at ourGaithersburg, Maryland laboratory. To renew our CLIA certificate, we are subject to survey and inspection every two years to assess compliance with programstandards. The regulatory and compliance standards applicable to the testing we perform may change over time, and any such changes could have a materialeffect on our business. Our current CLIA certificate expires on October 1, 2017, and our Medical Laboratory Permit expires on June 30, 2018.If our clinical laboratory is out of compliance with CLIA requirements, we may be subject to sanctions such as suspension, limitation or revocation of ourCLIA certificate, as well as a directed plan of correction, state on-site monitoring, civil money penalties, civil injunctive suit or criminal penalties. We mustmaintain CLIA compliance and certification in order to perform clinical laboratory tests and report patient test results. If we were to be found out ofcompliance with CLIA requirements and subjected to sanction, our business could be harmed.Federal Oversight of Laboratory Developed Tests and Research-Use-Only ProductsClinical laboratory tests, like our Acuitas MDRO Gene Test, are regulated under CLIA, as well as by applicable state laws. Historically, most laboratorydeveloped tests (“LDTs”), were not subject to FDA regulations applicable to medical devices, although reagents, instruments, software or componentsprovided by third parties and used to perform LDTs may be subject to regulation. FDA defines the term “laboratory developed test” as an IVD test that isintended for clinical use and designed, manufactured and used within a single laboratory. We believe that our Acuitas MDRO test products are LDTs.Currently, the FDA exercises enforcement discretion with respect to LDTs such that it does not enforce provisions of the Food, Drug and Cosmetic Actapplicable to IVD devices. In July 2014, due to the increased proliferation of LDTs for complex diagnostic testing, and concerns with several high-risk LDTsrelated to lack of evidentiary support for claims, erroneous results and falsification of data, the FDA notified Congress that it would issue guidance that, whenfinalized, would adopt a risk-based framework that would increase FDA oversight of LDTs. As part of this developing framework, the FDA issued draftguidance in October 2014, informing manufacturers of LDTs of its intent to collect information from laboratories regarding their current LDTs and newlydeveloped LDTs through a notification process. The FDA will use this information to classify LDTs and to prioritize enforcement of premarket reviewrequirements for categories of LDTs based on risk, beginning with LDTs that present the highest risk. Specifically, the FDA plans to use advisory panels toprovide recommendations to the agency on LDT risks, classification and prioritization of enforcement of applicable regulatory requirements on certaincategories of LDTs, as appropriate, for those tests not yet categorized.Some products are for research use only (“RUO”), or for investigational use only (“IUO”). RUO and IUO products are not intended for human clinical use andmust be properly labeled in accordance with FDA guidance. Claims for RUOs and IUOs related to safety, effectiveness, or clinical utility or that are intendedfor human diagnostic or prognostic use are prohibited. In November 2013, the FDA issued guidance titled “Distribution of In Vitro Diagnostic ProductsLabeled for Research Use Only or Investigational Use Only - Guidance for Industry and Food and Drug Administration Staff.” This guidance sets forth therequirements to utilize such designations, labeling requirements and acceptable distribution practices, among other requirements. Mere placement of an RUOor IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval or other requirements. The FDA maydetermine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed.We cannot predict the potential effect the FDA’s current and forthcoming guidance on LDTs and IUOs/RUOs will have on our product offerings or materialsused to perform our diagnostic services. While we qualify all materials used in our diagnostic services according to CLIA regulations, we cannot be certainthat the FDA might not promulgate rules or issue guidance documents that could affect our ability to purchase materials necessary for the performance of ourdiagnostic services. Should any of the reagents obtained by us from vendors and used in conducting our diagnostic services be affected by future regulatoryactions, our business could be adversely affected by those actions, including increasing the cost of service or delaying, limiting or prohibiting the purchaseof reagents necessary to perform the service.17 We cannot provide any assurance that FDA regulation, including premarket review, will not be required in the future for our surveillance and diagnosticservices, whether through additional guidance or regulations issued by the FDA, new enforcement policies adopted by the FDA or new legislation enacted byCongress. On November 17, 2015, the House Committee on Energy and Commerce held one such hearing entitled “Examining the Regulation of DiagnosticTests and Laboratory Operations.” We expect that new legislative proposals will be introduced from time to time. It is possible that legislation could beenacted into law or regulations or guidance could be issued by the FDA which may result in new or increased regulatory requirements for us to continue tooffer our diagnostic services or to develop and introduce new services.FDA’s Premarket Clearance and Approval RequirementsThe FDA classifies medical devices into one of three classes: Class 1, Class 2 or Class 3. Devices deemed to pose lower risk are placed into either Class 1 orClass 2. Class 1 or Class 2 devices that are exempt from the premarket notification process must comply with applicable regulations but can simply list theirproducts with the FDA. Class 1 or Class 2 devices that are non-exempt from the premarket notification process must comply with applicable regulations andsubmit a 510(k) premarket submission for review to receive clearance to list and market their devices. The 510(k) must establish substantial equivalence to apredicate device. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed notsubstantially equivalent to a previously cleared device, are placed in Class 3 and require premarket approval (“PMA”) before commercialization. Themajority of the medical devices manufactured by OpGen at its Woburn, Massachusetts facility (i.e., the AdvanDx products) are Class 1; one productmanufactured in Woburn is a Class 2 device. All of these products are non-exempt and required 510(k) premarket submissions. At this time our CLIA tests arenot required to be reviewed by the FDA; however, our LDTs would be considered non-exempt Class 2 devices and would require a 510(k) premarketsubmission to continue.All medical device manufacturers must register their establishments with the FDA; such registrations require the payment of user fees. In addition, both510(k) premarket submissions and PMA applications are subject to the payment of user fees, paid at the time of submission for FDA review. At this time ourCLIA lab is not required to register and list with the FDA; however, the Medical Device User Fee Act IV (“MFUFA IV”) negotiations currently taking placebetween the FDA and medical device manufacturers include discussions regarding user fees for clinical laboratories running LDTs. This new fee would be inaddition to the user fees required to operate a clinical laboratory.The FDA has issued a regulation outlining specific requirements for “specimen transport and storage containers.” “Specimen transport and storagecontainers” are medical devices if “intended to contain biological specimens, body waste, or body exudate during storage and transport” so that the specimencan be used effectively for diagnostic examination. Since medical devices are subject to registration and listing requirements, the reporting of corrections andremovals, and responsible for medical device reporting requirements, if the FDA were to determine that our sample collection container is a medical device,the manufacturer would be required to register and list with the FDA for us to use the container for diagnostic purposes. The specimen collection devicewould be exempt from premarket review, and from Quality System Regulation (“QSR”) requirements except for recordkeeping and complaint handlingrequirements, so long as no sterility claims are made, but the manufacturer would still be required to comply with applicable regulations.510(k) Clearance PathwayIf required to obtain 510(k) clearance for our future products or conversion of our Acuitas MDRO test products to diagnostic kits, such tests would beclassified as medical devices and we would have to submit a premarket notification demonstrating that the proposed device is substantially equivalent to apreviously cleared 510(k) device or a device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for thesubmission of premarket approval applications. FDA’s 510(k) clearance pathway usually takes from three to twelve months. On average the review time isapproximately six months, but it can take significantly longer than twelve months in some instances, as the FDA may require additional information,including clinical data, to make a determination regarding substantial equivalence.After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a new or majorchange in its intended use, will require a new 510(k) clearance or, depending on the modification, require premarket approval. The FDA requires eachmanufacturer to determine whether the proposed change requires submission of a new 510(k) notice, or a premarket approval, but the FDA can review anysuch decision and can disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require themanufacturer to cease marketing and/or recall the modified device until 510(k) clearance or premarket approval is obtained. If the FDA requires us to seek510(k) clearance or premarket approval for any modifications to a previously cleared product, we may be required to cease marketing or recall the modifieddevice until we obtain this clearance or approval. Also, in these circumstances, we may be subject to significant regulatory fines or penalties. We have madeand plan to continue to make additional product enhancements to products that we believe do not require new 510(k) clearances.18 Premarket Approval PathwayA premarket approval application must be submitted if a device cannot be cleared through the 510(k) process. The premarket approval application process isgenerally more costly and time consuming than the 510(k) process. A premarket approval application must be supported by extensive data including, but notlimited to, analytical, preclinical, clinical trials, manufacturing, statutory preapproval inspections, and labeling to demonstrate to the FDA’s satisfaction thesafety and effectiveness of the device for its intended use.After a premarket approval application is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submittedinformation. By statute, the FDA has 180 days to review the “accepted application,” although, generally, review of the application can take between one andthree years, but it may take significantly longer. During this review period, the FDA may request additional information or clarification of informationalready provided. Also during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the applicationand provide recommendations to the FDA as to the approvability of the device. The preapproval inspections conducted by the FDA include an evaluation ofthe manufacturing facility to ensure compliance with the QSR, as well as inspections of the clinical trial sites by the Bioresearch Monitoring group toevaluate compliance with good clinical practice and human subject protections. New premarket approval applications or premarket approval applicationsupplements are required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to thedevice’s indication for use, manufacturing process, labeling and design. Significant changes to an approved PMA require a 180-day supplement, whereas lesssubstantive changes may utilize a 30-day notice, or the 135-day supplement. Premarket approval supplements often require submission of the same type ofinformation as a premarket approval application, except that the supplement is limited to information needed to support any changes from the device coveredby the original premarket approval application, and may not require as extensive clinical data or the convening of an advisory panel. None of our productsare currently approved under a premarket approval.Clinical TrialsClinical trials are almost always required to support a premarket approval application and are usually required to support non-exempt Class 1 and Class 2510(k) premarket submissions. Clinical trials may also be required to support certain marketing claims. If the device presents a “significant risk,” as definedby the FDA, to human health, the FDA requires the device sponsor to file an investigational device exemption (“IDE”) application with the FDA and obtainIDE approval prior to conducting the human clinical trials. The IDE application must be supported by appropriate data, such as analytical, animal andlaboratory testing results, manufacturing information, and an Investigational Review Board (“IRB”) approved protocol showing that it is safe to test thedevice in humans and that the testing protocol is scientifically sound. The IDE application must be approved in advance by the FDA prior to initiation ofenrollment of human subjects. Clinical trials for a significant risk device may begin once the investigational device exemption application is approved bythe FDA. If the clinical trial design is deemed to be “non-significant risk,” the clinical trial may eligible for the “abbreviated” IDE requirements; in someinstances IVD clinical trials may be exempt from the more burdensome IDE requirements if certain labeling requirements are met. All clinical trials conductedto support a premarket submission must be conducted in accordance with FDA regulations and Federal and state regulations concerning human subjectprotection, including informed consent, oversight by an IRB and healthcare privacy requirements. A clinical trial may be suspended by the FDA or the IRBreview board at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the study.Even if a study is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device, or may be equivocal or otherwisenot be sufficient to obtain approval of our product. Similarly, in Europe the clinical study must be approved by the local ethics committee and in some cases,including studies of high-risk devices, by the Ministry of Health in the applicable country.21st Century Cures ActOn December 13, 2016, President Obama signed into law the 21st Century Cures Act. The Act contains several sections specific to antimicrobial innovationand antibiotic stewardship, and other provisions related to medical device innovations. The Company believes that implementation of the 21st CenturyCures Act may have a positive impact on the Company’s businesses through facilitating innovation and/or reducing the regulatory burden imposed onmedical device manufacturers, especially those involved in antimicrobial susceptibility testing. The Company cannot predict how and when these initiativesunder the Act will be implemented at the federal or state level in which we may do business, or the effect any future regulation will have on us.19 Pervasive and Continuing FDA RegulationNumerous regulatory requirements apply to our products classified as devices would continue to apply. These include: •product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action; •QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and otherquality assurance procedures during all aspects of the development and manufacturing process; •labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication; •clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use ofone of our cleared devices; •approval of product modifications that affect the safety or effectiveness of one of our cleared devices; •medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may havecaused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or seriousinjury if the malfunction of the device or a similar device were to recur; •post-approval restrictions or conditions, including post-approval study commitments; •post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectivenessdata for the device; •the FDA’s recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product thatis in violation of governing laws and regulations; •regulations pertaining to voluntary recalls; and •notices of corrections or removals.OpGen’s Woburn, Massachusetts facility is currently registered as an establishment with the FDA. If the LDTs performed in OpGen’s CLIA lab were deemedmedical devices by the FDA, then we and any third-party manufacturers of such devices would need to register with the FDA as medical device manufacturersand obtain all necessary state permits or licenses to operate our business. We and any third-party manufacturers would be subject to announced andunannounced inspections by the FDA to determine our compliance with quality system regulation and other regulations. Our Woburn, Massachusetts facilitywas inspected by the FDA in 2015. Following such inspection, the FDA issued a report of its findings and observations, typically referred to as “Form 483observations," primarily related to our quality systems and testing policies and documentation. We have responded to all inspection observations within therequired time frame and are working with the FDA’s Office of Compliance to satisfy the identified deficiencies.Failure to comply with applicable regulatory requirements could result in enforcement action by the FDA, which might include any of the followingsanctions: (1) untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; (2) unanticipated expenditures to address or defend suchactions; (3) customer notifications for repair, replacement and refunds; (4) recall, detention or seizure of our products; (5) operating restrictions or partialsuspension or total shutdown of production; (6) refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modifiedproducts; (7) operating restrictions; (8) withdrawing 510(k) clearances or PMA approvals that have already been granted; (9) refusal to grant export approvalfor our products; or (10) criminal prosecution.After a medical device is placed on the market, numerous regulatory requirements apply. These include: all of the relevant elements of the QSR, labelingregulations, restrictions on promotion and advertising, the medical device reporting (which requires the manufacturer to report to the FDA if its device mayhave caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were torecur), the Reports of Corrections and Removals regulations (which requires manufacturers to report certain recalls and field actions to the FDA), and otherpost-market requirements.Health Insurance Portability and Accountability ActUnder HIPAA, the Department of Health and Human Services (“HHS”), has issued regulations to protect the privacy and security of protected healthinformation used or disclosed by healthcare providers, such as us, and by certain vendors of ours, also known as our business associates. The regulationsinclude limitations on the use and disclosure of protected health information and impose notification requirements in the event of a breach of protectedhealth information. HIPAA also regulates standardization of data20 content, codes and formats used in healthcare transactions and standardization of identifiers for health plans and providers. Penalties for violations of HIPAAregulations include civil and criminal penalties.We have developed and implemented policies and procedures designed to comply with these regulations. The requirements under these regulations maychange periodically and could have an effect on our business operations if compliance becomes substantially more costly than under current requirements.In addition to Federal privacy regulations, there are a number of state laws governing confidentiality of health information that are applicable to our business.If our business expands internationally, we would be subject to compliance with other laws regarding confidentiality of health information and privacy.New laws governing privacy may be adopted in the future as well. We have taken steps to comply with health information privacy requirements to which weare aware that we are subject. However, we can provide no assurance that we are or will remain in compliance with diverse privacy requirements in all of thejurisdictions in which we do business. Failure to comply with privacy requirements could result in civil or criminal penalties, which could have a materiallyadverse effect on our business.Federal and State Physician Self-referral ProhibitionsAs a clinical laboratory, and manufacturer and seller of diagnostic tests, we are subject to the Federal physician self-referral prohibitions, commonly known asthe Stark Law, and to similar restrictions under the Maryland Physician Self-Referral Law. Together, these restrictions generally prohibit us from billing apatient or any governmental or private payor for any clinical laboratory services when the physician ordering the service, or any member of such physician’simmediate family, has an investment interest in or compensation arrangement with us, unless the arrangement meets an exception to the prohibition.Both the Stark Law and the Maryland Physician Self-Referral Law contain an exception for compensation paid to a physician for personal services renderedby the physician. We have compensation arrangements with a number of physicians for personal services, such as clinical advisory board services, speakingengagements and other consulting activities. We have structured these arrangements with terms intended to comply with the requirements of the personalservices exception to the Stark Law and the Maryland Physician Self-Referral Law.However, we cannot be certain that regulators would find these arrangements to be in compliance with the Stark Law, the Maryland Physician Self-ReferralLaw, or similar state laws. We would be required to refund any payments we receive pursuant to a referral prohibited by these laws to the patient, the payor orthe Medicare program, as applicable.Sanctions for a violation of the Stark Law include the following: •denial of payment for the services provided in violation of the prohibition; •refunds of amounts collected by an entity in violation of the Stark Law; •a civil penalty of up to $15,000 for each service arising out of the prohibited referral; •possible exclusion from Federal healthcare programs, including Medicare and Medicaid; and •a civil penalty of up to $100,000 against parties that enter into a scheme to circumvent the Stark Law’s prohibition.These prohibitions apply regardless of the reasons for the financial relationship and the referral. No finding of intent to violate the Stark Law is required for aviolation. In addition, knowing violations of the Stark Law may also serve as the basis for liability under the Federal False Claims Act, which prohibitsknowingly presenting, or causing to be presented, a false or fraudulent claim for payment to the U.S. Government.Further, if we submit claims in violation of the Maryland Physician Self-Referral Law, we can be held liable to the payer for any reimbursement received forthe services by us. Finally, other states have self-referral restrictions with which we have to comply that differ from those imposed by Federal and Marylandlaw. While we have attempted to comply with the Stark Law and the Maryland Physician Self-Referral Law, it is possible that some of our financialarrangements with physicians could be subject to regulatory scrutiny at some point in the future, and we cannot provide assurance that we will be found to bein compliance with these laws following any such regulatory review.21 Federal and State Anti-Kickback LawsThe Federal healthcare program Anti-Kickback Law makes it a felony for a person or entity, including a laboratory, to knowingly and willfully offer, pay,solicit or receive remuneration, directly or indirectly, in order to induce business that is reimbursable under any Federal healthcare program. A violation ofthe Anti-Kickback Law may result in imprisonment for up to five years and fines of up to $250,000 in the case of individuals and $500,000 in the case oforganizations. Convictions under the Anti-Kickback Law result in mandatory exclusion from Federal healthcare programs for a minimum of five years. Inaddition, HHS has the authority to impose civil assessments and fines and to exclude healthcare providers and others engaged in prohibited activities fromMedicare, Medicaid and other Federal healthcare programs. Actions which violate the Anti-Kickback Law also incur liability under the Federal False ClaimsAct.Although the Anti-Kickback Law applies only to Federal healthcare programs, a number of states, including Maryland, have passed statutes substantiallysimilar to the Anti-Kickback Law pursuant to which similar types of prohibitions are made applicable to all other health plans and third-party payers.Violations of Maryland’s anti-kickback law are punishable by tiered criminal penalties based on the crime with a maximum penalty of life imprisonment andfines of up to $200,000, or both. Civil penalties include three times the amount of any overpayment made in violation of the statute.Federal and state law enforcement authorities scrutinize arrangements between healthcare providers and potential referral sources to ensure that thearrangements are not designed as a mechanism to induce patient care referrals or induce the purchase or prescribing of particular products or services. The lawenforcement authorities, the courts and Congress have also demonstrated a willingness to look behind the formalities of a transaction to determine theunderlying purpose of payments between healthcare providers and actual or potential referral sources. Generally, courts have taken a broad interpretation ofthe scope of the Anti-Kickback Law, holding that the statute may be violated if merely one purpose of a payment arrangement is to induce referrals orpurchases.In addition to statutory exceptions to the Anti-Kickback Law, regulations provide for a number of safe harbors. If an arrangement meets the provisions of asafe harbor, it is deemed not to violate the Anti-Kickback Law. An arrangement must fully comply with each element of an applicable safe harbor in order toqualify for protection. There are no regulatory safe harbors to the Maryland anti-kickback law.Among the safe harbors that may be relevant to us is the discount safe harbor. The discount safe harbor potentially applies to discounts provided by providersand suppliers, including laboratories, to physicians or institutions. If the terms of the discount safe harbor are met, the discounts will not be consideredprohibited remuneration under the Anti-Kickback Law. Maryland does not have a discount safe harbor.The personal services safe harbor to the Anti-Kickback Law provides that remuneration paid to a referral source for personal services will not violate the Anti-Kickback Law provided all of the elements of that safe harbor are met. One element is that if the agreement is intended to provide for the services of thephysician on a periodic, sporadic or part-time basis, rather than on a full-time basis for the term of the agreement, the agreement must specify exactly theschedule of such intervals, their precise length, and the exact charge for such intervals. Our personal services arrangements with some physicians may notmeet the specific requirement of this safe harbor that the agreement specify exactly the schedule of the intervals of time to be spent on the services becausethe nature of the services, such as speaking engagements, does not lend itself to exact scheduling and therefore meeting this element of the personal servicessafe harbor is impractical. Failure to meet the terms of the safe harbor does not render an arrangement illegal. Rather, the government may evaluate sucharrangements on a case-by-case basis, taking into account all facts and circumstances.While we believe that we are in compliance with the Anti-Kickback Law and the Maryland anti-kickback law, there can be no assurance that ourrelationships with physicians, academic institutions and other customers will not be subject to investigation or challenge under such laws. If imposed for anyreason, sanctions under the Anti-Kickback Law and the Maryland anti-kickback law could have a negative effect on our business.Other Federal and State Fraud and Abuse LawsIn addition to the requirements discussed above, several other healthcare fraud and abuse laws could have an effect on our business. For example, provisionsof the Social Security Act permit Medicare and Medicaid to exclude an entity that charges the Federal healthcare programs substantially in excess of its usualcharges for its services. The terms “usual charge” and “substantially in excess” are ambiguous and subject to varying interpretations.Further, the Federal False Claims Act prohibits a person from knowingly submitting a claim, making a false record or statement in order to secure payment orretaining an overpayment by the Federal government. In addition to actions initiated by the government itself, the statute authorizes actions to be brought onbehalf of the Federal government by a private party having knowledge of the22 alleged fraud, also known as qui tam lawsuits. Because the complaint is initially filed under seal, the action may be pending for some time before thedefendant is even aware of the action. If the government is ultimately successful in obtaining redress in the matter or if the plaintiff succeeds in obtainingredress without the government’s involvement, then the plaintiff will receive a percentage of the recovery. It is not uncommon for qui tam lawsuits to be filedby employees, competitors or consultants.Finally, the Social Security Act includes its own provisions that prohibit the filing of false claims or submitting false statements in order to obtain payment.Violation of these provisions may result in fines, imprisonment or both, and possible exclusion from Medicare or Medicaid programs. Maryland has ananalogous state false claims act applicable to state health plans and programs, as do many other states.Maryland Laboratory LicensingMaryland requires that any site that performs clinical laboratory testing located in the state of Maryland, with limited exceptions, must be licensed by thestate, in addition to meeting Federal CLIA requirements. As such, our laboratory in Gaithersburg, Maryland holds a current Maryland license and is subject toon-site surveys by Maryland’s Office of Health Care Quality. Our license was renewed in 2016 and will expire in June 2018.Other States’ Laboratory LicensingIn addition to Maryland, other states including California, Florida, New York, Pennsylvania, Rhode Island, and the District of Columbia, require licensing ofout-of-state laboratories under certain circumstances. We have obtained licenses to receive specimens from Pennsylvania and Florida, and we have submittedan application to New York. We intend to obtain licenses from additional states and jurisdictions where we believe we are required to be licensed, andbelieve we are in compliance with applicable licensing laws.From time to time, we may become aware of other states that require out-of-state laboratories to obtain licensure in order to accept specimens from the state,and it is possible that other states do have such requirements or will have such requirements in the future. If we identify any other state with suchrequirements or if we are contacted by any other state advising us of such requirements, we intend to comply with such requirements.International RegulationSales of diagnostic tests like our Acuitas MDRO test products outside the United States would be subject to foreign government regulations, which varysubstantially from country to country. In order to market our products in other countries, we would need to obtain regulatory approvals and comply withextensive safety and quality regulations in other countries. OpGen’s Woburn, Massachusetts facility is currently ISO 13485 certified; the facility passed aninspection by our Notified Body in January 2017. While such certification is not required to distribute products internationally, the ISO 13485 certificationimplies that we are in compliance with the applicable regulatory requirements to distribute our medical devices internationally. OpGen currently distributesproducts in the European Union through its Denmark office. The time required to obtain approval by a foreign country may be longer or shorter than thatrequired for FDA clearance or approval, and the requirements may differ significantly. If we elect to, or are required to, seek clearance of or approval for any ofour products from the FDA, we may be able to commercialize such products with shorter lead time in international markets, but would need to establishinternational operations in order to do so.Environmental MattersOur operations require the use of hazardous materials (including biological materials) which subject us to a variety of Federal, state and local environmentaland safety laws and regulations. Some of these regulations provide for strict liability, holding a party potentially liable without regard to fault or negligence.We could be held liable for damages and fines as a result of our, or others’, business operations should contamination of the environment or individualexposure to hazardous substances occur. We cannot predict how changes in laws or new regulations will affect our business, operations or the cost ofcompliance.Glossary The following scientific, healthcare, regulatory and OpGen-specific terms are used throughout this Annual Report:“ACOs” means accountable care organizations, a voluntary combination of doctors, hospitals and other healthcare providers and other healthcare systemparticipants, including insurers, formed under the PPACA, to provide coordinated healthcare to patients.23 “Acuitas CR Elite” is a comprehensive test for detection of CRE including our Acuitas MDRO gene test, culture based detection, and Acuitas resistometesting on positive specimens.“Acuitas Lighthouse” is our bioinformatics platform, developed internally to provide real-time information on the MDRO status for patients and hospitals.We combine our molecular test information and microbiology test results from our customized CLIA-based tests to create Acuitas Lighthouse profiles forhospitals, health systems and communities, which we call our Acuitas Lighthouse informatics, and we are developing a more comprehensive and globalAcuitas Lighthouse Knowledgebase for use with our Acuitas Rapid Test in development. Acuitas Lighthouse profiling facilitates MDRO tracking and resultscan be aggregated with hospital data to provide customized reports including alerts, prevalence, trend analysis and transmission information.“Acuitas MDRO Gene Test” means our internally developed test that detects ten critical MDRO genes, including CRE (7 genes), ESBL (2 genes) and VREresistant organisms, from one patient swab.“Acuitas MDRO test products” means our Acuitas MDRO Gene Test, Acuitas CR Elite Test and Acuitas Resistome Test.“Acuitas Rapid Test” mean our diagnostic test in development, capable of providing genetic Resistome information for up to 150 drug resistance genes inone to three hours from specimen collection.“Acuitas Resistome Test” means our rapid, high resolution test that includes additional resistance genes for carbapenems, ESBLs and AmpC.“Annual Report” means this Annual Report on Form 10-K for the year ended December 31, 2016.“antibiotic stewardship” has been defined by the CDC to mean hospital-based programs dedicated to improving use of antibiotic therapy with the goal ofoptimizing the treatment of infections and reducing the adverse events associated with antibiotic use.“Argus System” means OpGen’s proprietary system used to perform Whole Genome Mapping.“bioinformatics” refers to methods, algorithms and processes for the collection, classification, storage and analysis of biochemical and biological data andinformation using computers, especially as applied in molecular genetics and genomics. Our focus is on acquiring such data and information related toMDROs to assist in diagnosis and screening of patients and antibiotic stewardship initiatives by acute care hospitals. When we use the term “advancedbioinformatics,” we mean bioinformatics combined with higher levels of complexity, sophistication and subject matter expertise related to MDROs,diagnostics, antibiotic stewardship, and the development of associated analysis tools, or the novel application of existing bioinformatics in future products orservices. In this Annual Report, we also sometimes use the phrase “bioinformatics products and services,” often interchangeably with “bioinformaticsplatform,” to describe the Company’s focus on the use of bioinformatics and advanced bioinformatics in its current and future product and service offerings.“bioinformatics platform” means a combination of software tools and analytical processes that streamline the production and analysis of bioinformatics data.When we use the term bioinformatics platform, we are primarily referring to Acuitas Lighthouse.“CDC” means the U.S. Centers for Disease Control and Prevention.“C. difficile” means Clostridium difficile, an MDRO that causes intestinal tract infections that can lead to sepsis.“CLIA” means the Clinical Laboratory Improvements Act of 1988, as amended.“CLIA lab” means a clinical or reference laboratory meeting the requirements of the Clinical Laboratory Improvements Act of 1988, as amended.“CMS” means the Centers for Medicare and Medicaid Services.“CRE” means carbapenem-resistant Enterobacteriaceae, an MDRO.“CRO” means carbapenem-resistant organisms; an MDRO.“DNA sequencing” is the process of determining the precise order of nucleotides within a DNA molecule.24 “epidemiologically linked” means situations where it is shown that one person is the source of an infection that spreads through contact to one or more otherpersons.“ESBL” means extended spectrum beta lactamase bacteria.“FDA” means the U.S. Food and Drug Administration.“HAIs” means hospital acquired infections. Such infections could arise first in the hospital or other healthcare setting, or could result from a patient,colonized with an organism, developing an active infection once admitted to the hospital or other healthcare setting.“HIPAA” means the Federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economicand Clinical Health Act (“HITECH Act”). HIPAA and HITECH Act are Federal laws mandating security and privacy of protected personal health informationof patients.“hospital biome” is used in this Annual Report to refer to the unique characteristic microbial environment found in a specific hospital or other healthcaresetting, which could change from time to time based on the MDRO profile of the institution.“ICU” means an intensive care unit in a health-care facility.“IVD” means in vitro diagnostic.“KPC” means Klebsiella pneumoniae Carbapenemase, an MDRO.“LIMS” means a laboratory information management system.“MDRO” means a multidrug-resistant organism.“microfluidic” means devices or processes that are designed, manufactured or formulated to accommodate applications that require very small volumes offluid, on the order of nanoliters or picoliters.“PPACA” means the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act.“QSR” means Quality System Regulation.“USDA” means the United States Department of Agriculture.“WHO” means the World Health Organization.“Whole Genome Mapping” means OpGen’s proprietary technology that provides a customer with a high resolution, ordered, whole genome restriction mapgenerated from single DNA molecules extracted from organisms, such as bacteria, yeast or other fungi, plants or animals and humans. Whole GenomeMapping compliments genome assembly and enables scientist to identify highly repetitive regions, tandem repeats and translocations that are difficult toidentify and clarify with sequencing alone.EmployeesAs of December 31, 2016, we had 62 employees worldwide, with 61 employed in the United States and 1 employed in Denmark. There are 59 full-timeemployees. The 61 employees in the United States primarily work in our Gaithersburg, Maryland and Woburn, Massachusetts locations. None of ouremployees are the subject of collective bargaining arrangements, and our management considers its relationships with employees to be good.Corporate InformationOpGen, Inc. was incorporated in Delaware in 2001. On July 14, 2015, the Company acquired AdvanDx, Inc., a Delaware corporation, as a wholly ownedsubsidiary in a merger transaction. The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Marylandand Woburn, Massachusetts. The Company also has operations in Copenhagen, Denmark.25 Available InformationThe Company maintains a website at www.opgen.com. Our Code of Business Conduct and Ethics is available on our website. We are not incorporating ourwebsite into this Annual Report. Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments to thosereports, filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, are available free of charge on our website as soon as practicable afterelectronic filing of such material with, or furnishing it to, the SEC. This information may be read and copied at the Public Reference Room of the SEC at 100F Street, N.E., Washington D.C. 20549. The SEC also maintains an internet website that contains reports, proxy statements, and other information aboutissuers, like OpGen who file electronically with the SEC. The address of the site is http://www.sec.gov.Item 1A. Risk FactorsThe following are significant factors known to us that could materially harm our business, financial condition or operating results or could cause our actualresults to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statement made in this AnnualReport. The risks described are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that we currently deem to beimmaterial, also may adversely affect our business, financial condition and operating results. If any of these risks actually occur, our business, financialcondition, and operating results could suffer significantly.Risks Related to Our BusinessWe have a history of losses, and we expect to incur losses for the next several years. The report of our independent registered public accounting firm on ourfinancial statements for the years ended December 31, 2016 and 2015 contains explanatory language that substantial doubt exists about our ability tocontinue as a going concern.We have incurred substantial losses since our inception, and we expect to continue to incur additional losses for the next several years. For the years endedDecember 31, 2016 and 2015, we had net losses of $19.2 million and $17.4 million, respectively. From our inception through December 31, 2016, we had anaccumulated deficit of $133.3 million. The report of our independent registered public accounting firm on our financial statements for the years endedDecember 31, 2016 and 2015 contains explanatory language that substantial doubt exists about our ability to continue as a going concern. We completed anumber of financings in 2016, including a private investment public equity, or PIPE, in May and June to members of management, employees and accreditedinvestors, including Merck GHI and jVen Capital, and an at-the-market, or ATM, public offering commenced in September 2016. The net proceeds from such2016 financings were approximately $13.9 million.We expect to continue to incur significant operating expenses relating to, among other things: •commercializing our rapid pathogen identification and Acuitas MDRO and Acuitas Lighthouse bioinformatics services; •developing our Acuitas Rapid Test products and services for antibiotic resistance testing, and our automated rapid molecular diagnosticproducts; •developing, presenting and publishing additional clinical and economic utility data intended to increase clinician adoption of our current andfuture products and services, including the efficacy of use of our products in MDRO surveillance activities; •expansion of our operating capabilities; •maintenance, expansion and protection of our intellectual property portfolio and trade secrets; •future clinical trials as we seek regulatory approval for some of our product offerings; •expansion of the size and geographic reach of our sales force and our marketing capabilities to commercialize potential future products andservices; and •continued focus on recruiting and retaining our quality assurance and compliance personnel and activities.Even if we achieve significant revenues, we may not become profitable, and even if we achieve profitability, we may not be able to sustain or increaseprofitability on a quarterly or annual basis. Our failure to become and remain consistently profitable could adversely affect the market price of our commonstock and could significantly impair our ability to raise capital, expand our business or continue to pursue our growth strategy. We believe that current cashon hand will be sufficient to fund operations into the second quarter of 2017. In the event we are unable to successfully raise additional capital during orbefore the second quarter of 2017, we will not have sufficient cash flows and liquidity to finance our business operations as currently contemplated.Accordingly, in such circumstances we would be compelled to reduce general and administrative expenses and delay research and development projects,26 including the purchase of scientific equipment and supplies, until we are able to obtain sufficient financing. We have no committed sources of capital andmay find it difficult to raise money on terms favorable to us or at all. The failure to obtain sufficient capital to support our operations would have an adverseeffect on our business, financial condition and results of operations.We expect to make significant additional investment in the future related to our diagnostic products and services, which investments will requireadditional financing transactions through the issuance of equity or debt. If we are unable to make such investments our business will suffer.We anticipate that we will need to make significant investments in our Acuitas Rapid Test in development, Acuitas MDRO tests, bioinformatics services andQuickFISH products and services in order to make our business profitable. We have identified potential synergies for future rapid diagnostic testdevelopments based on our existing product and service offerings, but need to expend significant investments to develop such products and services. Therecan be no assurance that we can obtain sufficient resources or capital from operations or future financings to support these development activities.To meet our capital needs, we are considering multiple alternatives, including, but not limited to, additional equity financings, debt financings and otherfunding transactions, licensing and/or partnering arrangements and business combination transactions. In September 2016, we filed a shelf registrationstatement on Form S-3 to offer for sale and sell, from time to time, up to $50 million of shares of our common stock. As a smaller reporting company, we arelimited to sales under such shelf registration statement, or similar offerings, of no more than one-third of our public float over a rolling twelve-monthperiod. In September 2016, we commenced an “at the market,” or ATM, offering under the shelf registration statement to raise up to $11.5 million. As ofDecember 31, 2016, we have raised approximately $4.7 million under the ATM offering. We believe that additional equity financings are the most likelysource of capital. There can be no assurance that we will be able to complete any such financing transaction on acceptable terms or otherwise.We believe that current cash on hand will be sufficient to fund operations into the second quarter of 2017. In the event we are unable to successfully raiseadditional capital during or before the second quarter of 2017, we will not have sufficient cash flows and liquidity to finance our business operations ascurrently contemplated. Accordingly, in such circumstances we would be compelled to immediately reduce general and administrative expenses and delayresearch and development projects, including the purchase of scientific equipment and supplies, until we is able to obtain sufficient financing. If suchsufficient financing is not received timely, we would then need to pursue a plan to license or sell assets, seek to be acquired by another entity, ceaseoperations and/or seek bankruptcy protection.In July 2015, in connection with our acquisition of AdvanDx, Merck GHI made investments in the Company, including a $1 million senior securedpromissory note secured by a security interest in substantially all of our assets, including our intellectual property assets. The secured promissory noterequires interest-only payments at a rate of 8% per annum for two years, with the principal due and payable on July 14, 2017. Such secured creditor rightscould negatively impact our ability to raise money in the future. If we default on payments under the promissory note, Merck GHI has the rights of a securedcreditor. If those rights are exercised, it could have a material adverse effect on our financial condition.Our products and services may never achieve significant commercial market acceptance.Our products and services may never gain significant acceptance in the marketplace and, therefore, may never generate substantial revenue or profits for us.Our ability to achieve commercial market acceptance for our products will depend on several factors, including: •our ability to convince the medical community of the clinical utility of our products and services and their potential advantages over existingtests, including our surveillance services offering, despite the lack of reimbursement for such services; •our ability to successfully develop automated rapid pathogen identification and antibiotic resistance testing products and services, includingbioinformatics, and convince hospitals and other healthcare providers of the patient safety, improved patient outcomes and potential costsavings that could result; •our ability to grow our microbial isolate and antibiotic resistance genes knowledgebase; •our ability to convince the medical community of the accuracy and speed of our products and services, as contrasted with the current methodsavailable; and •the willingness of hospitals and physicians to use our products and services.27 Our future success is dependent upon our ability to expand our customer base.The current customers we are targeting for our rapid pathogen identification and Acuitas MDRO test products and services are hospital systems, acute carehospitals, particularly those with advanced care units, such as intensive care units, community-based hospitals and governmental units, such as public healthfacilities. We need to provide a compelling case for the savings, patient safety and recovery, reduced length of stay and reduced costs that come fromadopting our MDRO diagnosis and management products and services. If we are not able to successfully increase our customer base, sales of our products andour margins may not meet expectations. Attracting new customers and introducing new products and services requires substantial time and expense. Anyfailure to expand our existing customer base, or launch new products and services, would adversely affect our ability to improve our operating results.We have seen declining revenues from our current customers for our QuickFISH products as we work to automate and expand our current product offerings.We may not be successful in developing such automated rapid pathogen identification products, which would materially, adversely affect our business.During the third quarter of 2016, we encountered supply chain issues that impacted our ability to deliver our QuickFISH products to customers. Althoughsuch supply chain issues were resolved, future supply chain or other manufacturing issues could adversely affect our ability to deliver our products to ourcustomers and adversely impact our revenues and results of operations. We are developing new diagnostic products for the more rapid identification of MDROs and antibiotic resistance genomic information. If we are unableto successfully develop, receive regulatory clearance or approval for or commercialize such new products and services, our business will be materially,adversely affected.We are currently beginning development of a new one to three hour antibiotic resistance diagnostic product that we believe could help address many of thecurrent issues with the need for more rapid identification of infectious diseases and testing for antibiotic resistance. Development of new diagnostic productsis difficult and we cannot assure you that we will be successful in such product development efforts, or, if successful, that we will receive the necessaryregulatory clearances to commercialize such products. Our intent is to identify over 100 antibiotic resistance genes to help guide clinician antibiotic therapydecisions when test results are evaluated using the Acuitas Lighthouse. Although we have demonstrated preliminary feasibility, and confirmedgenotype/phenotype predictive algorithms, such product development efforts will require us to work collaboratively with other companies, academic andgovernment laboratories, and healthcare providers to access sufficient numbers of microbial isolates, develop the diagnostic tests, identify and license a third-party rapid array platform, successfully conduct the necessary clinical trials and apply for and receive regulatory clearances or approvals for the intended useof such diagnostic tests. In addition, we would need to successfully commercialize such products. Such product development, clearance or approval andcommercialization activities are time-consuming, expensive and we are not assured that we will have sufficient funds to successfully complete such efforts. We currently estimate that such antibiotic resistance diagnostic tests will be commercially available by 2019. Any significant delays or failures in thisprocess could have a material adverse effect on our business and financial condition.We may offer these products in development to the research use only market or for other non-clinical research uses prior to receiving clearance or approval tocommercialize these products in development for use in the clinical setting. We will need to comply with the applicable laws and regulations regarding suchother uses. Failure to comply with such laws and regulations may have a significant impact on the Company. Our sales cycle is lengthy and variable, which makes it difficult for us to forecast revenue and other operating results.The sales cycles for our Acuitas MDRO test products and services and for our Acuitas Lighthouse services are lengthy, which makes it difficult for us toaccurately forecast revenues in a given period, and may cause revenue and operating results to vary significantly from period to period. Potential customersfor our products typically need to commit significant time and resources to evaluate our products, and their decision to purchase our products may be furtherlimited by budgetary constraints and numerous layers of internal review and approval, which are beyond our control. We spend substantial time and effortassisting potential customers in evaluating our products. Even after initial approval by appropriate decision makers, the negotiation and documentationprocesses for the actual adoption of our products on a facility-wide basis can be lengthy. As a result of these factors, based on our experience to date, our salescycle, the time from initial contact with a prospective customer to routine commercial use of our products, has varied and could be 12 months or longer,which has made it difficult for us to accurately project revenues and operating results. In addition, the revenue generated from sales of our products mayfluctuate from time to time due to changes in the testing volumes of our customers. As a result, our results may fluctuate on a quarterly basis, which mayadversely affect the price of our common stock.28 We have in the past, and in the future may, enter into collaborations with third parties to develop product and services candidates. If these collaborationsare not successful, our business could be adversely affected. We have entered into licensing and collaboration agreements with third parties in the past related to our Whole Genome Mapping products and services andmay enter into additional collaborations in the future related to our MDRO and bioinformatics products and services. Such collaborations may be withpharmaceutical companies, platform companies or other participants in our industry. We have limited control over the amount and timing of resources thatany such collaborators could dedicate to the development or commercialization of the subject matter of any such collaboration. Our ability to generaterevenues from these arrangements would depend on our and our collaborator’s abilities to successfully perform the functions assigned to each of us in thesearrangements. Our relationships with future collaborators may pose several risks, including the following: •collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; •collaborators may not perform their obligations as expected; •we may not achieve any milestones, or receive any milestone payments, under our collaborations, including milestones and/or payments thatwe expect to achieve or receive; •the clinical trials, if any, conducted as part of these collaborations may not be successful; •a collaborator might elect not to continue or renew development or commercialization programs based on clinical trial results, changes in thecollaborator’s strategic focus or available funding or external factors, such as an acquisition, that diverts resources or creates competingpriorities; •we may not have access to, or may be restricted from disclosing, certain information regarding product or services candidates being developedor commercialized under a collaboration and, consequently, may have limited ability to inform our stockholders about the status of suchproduct or services candidates; •collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our productcandidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized underterms that are more economically attractive than ours; •product or services candidates developed in collaboration with us may be viewed by our collaborators as competitive with their own product orservices, which may cause collaborators to cease to devote resources to the commercialization of our product or services candidates; •a collaborator with marketing and distribution rights to one or more of our product or services candidates that achieve regulatory approval maynot commit sufficient resources to the marketing and distribution of any such product candidate; •disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course ofdevelopment of any product or services candidates, may cause delays or termination of the research, development or commercialization of suchproduct or services candidates, may lead to additional responsibilities for us with respect to such product or services candidates or may result inlitigation or arbitration, any of which would be time-consuming and expensive; •collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as toinvite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; •disputes may arise with respect to the ownership of intellectual property developed pursuant to a collaboration; •collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and •collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital topursue further development or commercialization of the applicable product or services candidates.If our future collaborations do not result in the successful development and commercialization of products or services, we may not receive any future researchfunding or milestone or royalty payments under the collaborations. If we do not receive the funding we would expect under these agreements, ourdevelopment of product and services candidates could be delayed and we may need additional resources to develop our product candidates. 29 We may not be successful in finding strategic collaborators for continuing development of certain of our product or services candidates or successfullycommercializing or competing in the market for certain indications.We may seek to develop strategic partnerships for developing certain of our product or services candidates, due to capital costs required to develop theproduct or services candidates or manufacturing constraints. We may not be successful in our efforts to establish such a strategic partnership or otheralternative arrangements for our product or services candidates because our research and development pipeline may be insufficient, our product or servicescandidates may be deemed to be at too early of a stage of development for collaborative effort or third parties may not view our product or servicescandidates as having the requisite potential to demonstrate commercial success.If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms or at all, we may have to curtail the development of aproduct or service candidate, reduce or delay our development program, delay our potential commercialization, reduce the scope of any sales or marketingactivities or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to fund development orcommercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptableterms or at all. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development andcommercialization activities, we may not be able to further develop our product candidates and our business, financial condition, results of operations andprospects may be materially and adversely affected.We may enter into agreements with U.S. or other government agencies, which could be subject to uncertain future funding.The presence of MDROs and the need for antibiotic stewardship activities have prompted state, federal and international government agencies to developprograms to combat the effects of MDROs. In the future, we may seek to enter into agreements with governmental funding sources or contract withgovernment healthcare organizations to sell our products and services. If we enter into such funding agreements, we would rely on the continuedperformance by these government agencies of their responsibilities under these agreements, including adequate continued funding of the agencies and theirprograms. We have no control over the resources and funding that government agencies may devote to these agreements, which may be subject to annualrenewal.Government agencies may fail to perform their responsibilities under these agreements, which may cause them to be terminated by the government agencies.In addition, we may fail to perform our responsibilities under these agreements. Any government agreements would be subject to audits, which may occurseveral years after the period to which the audit relates. If an audit identified significant unallowable costs, we could incur a material charge to our earnings orreduction in our cash position. As a result, we may be unsuccessful entering, or ineligible to enter, into future government agreements.We are an early commercial stage company and may never be profitable.We rely principally on the commercialization of our QuickFISH and Acuitas MDRO test products and our Acuitas Lighthouse services to generate futurerevenue growth. To date, the Acuitas MDRO test products and Acuitas Lighthouse services have delivered only minimal revenue. We believe that ourcommercialization success is dependent upon our ability to significantly increase the number of hospitals, long-term care facilities and other inpatienthealthcare settings that use our products. We have experienced very limited revenue and customer adoption for our Acuitas MDRO products and services todate. If demand for products does not increase as quickly as we have planned, we may be unable to increase our revenue levels as expected. We are currentlynot profitable. Even if we succeed in increasing adoption of our products by our target markets, maintaining and creating relationships with our existing andnew customers and developing and commercializing additional molecular testing products, we may not be able to generate sufficient revenue to achieve orsustain profitability.The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists and laboratory and field personnelcould adversely affect our business.Our success depends largely on the skills, experience and performance of key members of our executive management team. The efforts of each of thesepersons will be critical to us as we continue to develop our products and services and as we attempt to transition to a company with broader product offerings.If we were to lose one or more of these key employees, we may experience difficulties in competing effectively, developing our technologies andimplementing our business strategies.Our research and development programs and commercial laboratory operations depend on our ability to attract and retain highly skilled scientists andtechnicians, particularly as we seek to further integrate operations of the combined company. We may not be able to attract or retain qualified scientists andtechnicians in the future due to the intense competition for qualified personnel among life science businesses. We also face competition from universities,public and private research institutions and other organizations in recruiting and retaining highly qualified scientific personnel.30 In addition, our success depends on our ability to attract and retain laboratory and field personnel with extensive experience in infection control in inpatientsettings. We may have difficulties locating, recruiting or retaining qualified salespeople, which could cause a delay or decline in the rate of adoption of ourcurrent and future products and service offerings. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, wemay experience constraints that will adversely affect our ability to support our discovery, development, verification and commercialization programs.We have limited experience in marketing and selling our products, and if we are unable to adequately address our customers’ needs, it could negativelyimpact sales and market acceptance of our product and we may never generate sufficient revenue to achieve or sustain profitability.We sell our products through our own direct sales force, which sells our Acuitas MDRO test products and services, which includes our QuickFISH products,and our Acuitas Lighthouse bioinformatics services and surveillance product and services offerings. All of these products and services may be offered andsold to different potential customers or involve discussions with multiple personnel in in-patient facilities. Our future sales will depend in large part on ourability to increase our marketing efforts and adequately address our customers’ needs. The inpatient healthcare industry is a large and diverse market. As aresult, we believe it is necessary to maintain a sales force that includes sales representatives with specific technical backgrounds that can support ourcustomers’ needs. We will also need to attract and develop sales and marketing personnel with industry expertise. Competition for such employees is intense.We may not be able to attract and retain sufficient personnel to maintain an effective sales and marketing force. If we are unable to successfully market ourproducts and adequately address our customers’ needs, it could negatively impact sales and market acceptance of our products and we may never generatesufficient revenue to achieve or sustain profitability.We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.We commenced the formal commercial launch of our CLIA lab in late 2013, launched our Acuitas MDRO Gene Test in the second quarter of 2014, launchedour Acuitas CR Elite Test in December 2014, our Acuitas Resistome Test in the second quarter of 2015, and we began providing Acuitas Lighthouseinformatics in December 2015. In addition, we integrated the sales of our QuickFISH products beginning in the third quarter of 2015. We anticipate futuregrowth in our business operations. This future growth could create strain on our organizational, administrative and operational infrastructure, includinglaboratory operations, quality control, customer service and sales force management. We may not be able to maintain the quality or expected turn-aroundtimes of our diagnostic or screening results, or satisfy customer demand as it grows. Our ability to manage our growth properly will require us to continue toimprove our operational, financial and management controls, as well as our reporting systems and procedures. The time and resources required to implementthe systems to handle such growth is uncertain, and failure to complete this in a timely and efficient manner could adversely affect our operations.We may fail to realize some or all of the anticipated benefits of the business combination of OpGen and AdvanDx, which may adversely affect the value ofour common stock.The success of the continued integration of AdvanDx will depend, in part, on our ability to realize the anticipated benefits and cost savings from combiningthe respective business and operations of OpGen and AdvanDx. To realize these anticipated benefits and cost savings, we must successfully combine theacquired business with our legacy operations and integrate our respective operations, technologies and personnel, which is particularly challenging given thegeographic and cultural differences between the personnel and facilities based in Maryland and Massachusetts, plus the European operations of AdvanDx,and the lack of experience we have in combining businesses. If we are not able to fully achieve these objectives within the anticipated time frame or at all, theanticipated benefits and cost savings of the acquisition may not be realized fully or at all or may take longer to realize than expected, and the value of ourcommon stock may be adversely affected. In addition, the overall integration of the businesses is a complex, time-consuming and expensive process that,without proper planning and effective and timely implementation, could significantly disrupt our operations.Risks in integrating AdvanDx into our operations in order to realize the anticipated benefits of the acquisition include, among other factors: •coordinating research and development activities to enhance the introduction of new diagnostic tests and technology of the combinedbusiness; •failure to successfully integrate and harmonize financial reporting and information technology systems of the two companies; •retaining each company’s relationships with its partners; •retaining and integrating key employees from OpGen and AdvanDx;31 •managing effectively the diversion of management’s attention from business matters to integration issues; •combining research and development capabilities effectively and quickly; •integrating partnership efforts so that new partners acquired can easily do business with us; and •transitioning all facilities to a common information technology environment.Actual cost synergies, if achieved at all, may be lower than we expect and may take longer to achieve than anticipated. If we are not able to adequatelyaddress these challenges, we may be unable to successfully integrate the operations of the business acquired from AdvanDx into our own, or to realize theanticipated benefits of the integration. The anticipated benefits and synergies assume a successful integration and are based on projections, which areinherently uncertain, and other assumptions. Even if integration is successful, anticipated benefits and synergies may not be achieved. An inability to realizethe full extent of, or any of, the anticipated benefits of the acquisition, as well as any delays encountered in the integration process, could have an adverseeffect on our business and results of operations, which may affect the value of the shares of our common stock.If the utility of our current products and products in development is not supported by studies published in peer-reviewed medical publications, the rate ofadoption of our current and future products and services by clinicians and healthcare facilities may be negatively affected.The results of our clinical and economic validation studies involving our Acuitas MDRO test and bioinformatics products and services have been presentedat major infectious disease and infection control society meetings. We need to maintain and grow a continued presence in peer-reviewed publications topromote clinician adoption of our products. We believe that peer-reviewed journal articles that provide evidence of the utility of our current and futureproducts and services, and adoption by key opinion leaders in the infectious disease market are very important to our commercial success. Clinicianstypically take a significant amount of time to adopt new products and testing practices, partly because of perceived liability risks and the uncertainty of afavorable cost/benefit analysis. It is critical to the success of our sales efforts that we educate a sufficient number of clinicians and administrators about ourproducts and demonstrate their clinical benefits. Clinicians may not adopt our current and future products and services unless they determine, based onpublished peer-reviewed journal articles and the experience of other clinicians, that our products provide accurate, reliable, useful and cost-effectiveinformation that is useful in MDRO diagnosis, screening and outbreak prevention. If our current and future products and services or the technologyunderlying our products and services or our future product offerings do not receive sufficient favorable exposure in peer-reviewed publications, the rate ofclinician adoption could be negatively affected. The publication of clinical data in peer-reviewed journals is a crucial step in commercializing our products,and our inability to control when, if ever, results are published may delay or limit our ability to derive sufficient revenue from any product that is the subjectof a study.The performance of clinical and economic utility studies is expensive and demands significant attention from our management team.The performance of clinical and economic utility studies is expensive and demands significant attention from our management team. Data collected fromthese studies may not be positive or consistent with our existing data, or may not be statistically significant or compelling to the medical community. If theresults obtained from our ongoing or future studies are inconsistent with certain results obtained from our previous studies, adoption of our current and futureproducts and services would suffer and our business would be harmed.Our products and services are not covered by reimbursement by Medicare, Medicaid and other governmental and third-party payors. If we cannot convinceour customers that the savings from use of our products and services will increase their overall reimbursement, our business could suffer.Our products and services do not currently receive reimbursement from Medicare, Medicaid, other governmental payors or commercial third-party payors.The recent policy and rule changes in reimbursement announced by CMS, including potential financial incentives for reductions in hospital acquiredinfection, and penalties and decreased Medicare reimbursement for patients with HAIs provide us with an opportunity to establish a business case for thepurchase and use of our screening and diagnostic products and services. If we cannot convince our customers that the savings from use of our products andservices will increase or stabilize their overall profitability and improve clinical outcomes, our business will suffer.If our sole laboratory facility or manufacturing facility becomes inoperable, we will be unable to perform Acuitas MDRO test services, or manufacture ourQuickFISH PNA Fish products, and our business will be harmed.We perform all of our Acuitas MDRO and Acuitas Lighthouse services in our CLIA laboratory located in Gaithersburg, Maryland. We do not have redundantlaboratory facilities. Our facility and the equipment we use to perform our diagnostic and screening assays32 would be costly to replace and could require substantial lead time to repair or replace, if damaged or destroyed. The facility may be harmed or renderedinoperable by natural or man-made disasters, including flooding and power outages, which may render it difficult or impossible for us to perform our tests forsome period of time. The inability to perform our tests may result in the loss of customers or harm our reputation, and we may be unable to regain thosecustomers in the future. Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient tocover all of our potential losses and may not continue to be available to us on acceptable terms, if at all.In order to establish a redundant laboratory facility, we would have to spend considerable time and money securing adequate space, constructing the facility,recruiting and training employees, and establishing the additional operational and administrative infrastructure necessary to support a second facility.Additionally, any new clinical laboratory facility opened by us would be required to be certified under CLIA, a federal law that regulates clinical laboratoriesthat perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. Wewould also be required to secure and maintain state licenses required by several states, including Maryland, California, Florida, New York and Pennsylvaniawhich can take a significant amount of time and result in delays in our ability to begin operations at that facility. We currently have active licenses inMaryland, Florida and Pennsylvania. If we failed to secure any such licenses, we would not be able to process samples from recipients in such states. We alsoexpect that it would be difficult, time-consuming and costly to train, equip and use a third-party to perform tests on our behalf. We could only use anotherfacility with the established state licensures and CLIA certification necessary to perform our current or future tests following validation and other requiredprocedures. We cannot assure you that we would be able to find another CLIA-certified facility willing or able to adopt our current or future tests and complywith the required procedures, or that this laboratory would be willing or able to perform the tests for us on commercially reasonable terms.We manufacture our QuickFISH and PNA Fish products in a leased facility located in Woburn, Massachusetts. If demand for these products increase beyondour current forecasts or, regulatory requirements arise, we may not be able to meet our obligations to produce these products, and backlog or reduced demandfor such products could occur. If we decide to relocate the facility, we will need to obtain all necessary FDA certifications, which could delay our ability tomanufacture these products. If any of these issues occur, it could have a material adverse effect on our financial condition and results of operations.In order to meet the turn-around time required for our Acuitas MDRO test services, we rely on transport of specimens to our sole laboratory facility; anydisruption in such transport could significantly adversely affect our business.Our current customers for our Acuitas MDRO test services are located near our sole laboratory facility in Gaithersburg, Maryland. As we expand our customerbase, and the jurisdictions where we are licensed to provide our CLIA laboratory services, we will need to secure the proper licenses for shipment ofspecimens and rely on accurate and timely delivery of the specimens by overnight delivery services such as FedEx. Any failure to procure the proper licenses,to comply with the license regulations or to receive undamaged specimens from overnight delivery services could adversely affect our business andreputation.We rely on a limited number of suppliers or, in some cases, sole suppliers, for some of our laboratory instruments and materials and may not be able to findreplacements or immediately transition to alternative suppliers.We rely on several sole suppliers and manufacturers, including Fluidigm Corporation, for supplying certain laboratory reagents, raw materials, supplies andsubstances which we use in our laboratory operations and products and to manufacture our products. An interruption in our operations could occur if weencounter delays or difficulties in securing these items or manufacturing our products, and if we cannot, then obtain an acceptable substitute. Any suchinterruption could significantly affect our business, financial condition, results of operations and reputation.We believe that there are only a few other equipment manufacturers that are currently capable of supplying and servicing the equipment and other suppliesand materials necessary for our laboratory operations. The use of equipment or materials furnished by these replacement suppliers would require us to alterour laboratory operations. Transitioning to a new supplier would be time consuming and expensive, may result in interruptions in our laboratory operations,could affect the performance specifications of our laboratory operations or could require that we revalidate our products. There can be no assurance that wewill be able to secure alternative equipment and other materials, and bring such equipment and materials on line and revalidate them without experiencinginterruptions in our workflow. If we should encounter delays or difficulties in securing, reconfiguring or revalidating the equipment we require for ourproducts, our business, financial condition, results of operations and reputation could be adversely affected.If we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue or achieve and sustain profitability.Our competitors include rapid diagnostic testing and traditional microbiology companies, commercial laboratories, information technology companies, andhospital laboratories who may internally develop testing capabilities. Principal competitive factors in our33 target market include: organizational size, scale, and breadth of product offerings; rapidity of test results; quality and strength of clinical and analyticalvalidation data and confidence in diagnostic results; cost effectiveness; ease of use; and regulatory approval status.Our principal competition comes from traditional methods used by healthcare providers to diagnose and screen for MDROs and from other moleculardiagnostic companies creating screening and diagnostic products such as Cepheid, Becton-Dickinson, bioMérieux, Accelerate Diagnostics, T2 BiosystemsGenMark and Nanosphere.We also face competition from commercial laboratories, such as Bio-Reference Laboratories, Inc., Laboratory Corporation of America Holdings, QuestDiagnostics Incorporated and EuroFins, which have strong infrastructure to support the commercialization of diagnostic services.Competitors may develop their own versions of competing products in countries where we do not have patents or where our intellectual property rights arenot recognized.Many of our potential competitors have widespread brand recognition and substantially greater financial, technical, research and development and sellingand marketing capabilities than we do. Others may develop products with prices lower than ours that could be viewed by hospitals, physicians and payers asfunctionally equivalent to our product and service offering, or offer products at prices designed to promote market penetration, which could force us to lowerthe list prices of our product and service offerings and affect our ability to achieve profitability. If we are unable to change clinical practice in a meaningfulway or compete successfully against current and future competitors, we may be unable to increase market acceptance and sales of our products, which couldprevent us from increasing our revenue or achieving profitability and could cause our stock price to decline.If we are unable to develop products to keep pace with rapid technological, medical and scientific change, our operating results and competitive positioncould be harmed. New test development involves a lengthy and complex process, and we may not be successful in our efforts to develop and commercializeour diagnostic and screening products and services. The further development and commercialization of additional diagnostic and screening product andservice offering are key to our growth strategy.A key element of our strategy is to discover, develop, validate and commercialize a portfolio of additional diagnostic and screening products and services torapidly diagnose and effectively treat MDRO infections and reduce the associated costs to patients, inpatient facilities and the healthcare industry. Wecannot assure you that we will be able to successfully complete development of or commercialize any of our planned future products and services, or thatthey will be clinically usable. The product development process involves a high degree of risk and may take up to several years or more. Our new productdevelopment efforts may fail for many reasons, including: •failure of the test at the research or development stage; •lack of clinical validation data to support the effectiveness of the test; •delays resulting from the failure of third-party suppliers or contractors to meet their obligations in a timely and cost-effective manner; •failure to obtain or maintain necessary certifications, licenses, clearances or approvals to market or perform the test; or •lack of commercial acceptance by in-patient healthcare facilities.Few research and development projects result in commercial products, and success in early clinical studies often is not replicated in later studies. At anypoint, we may abandon development of new products, or we may be required to expend considerable resources repeating clinical studies or trials, whichwould adversely impact the timing for generating potential revenues from those new products. In addition, as we develop new products, we will have to makeadditional investments in our sales and marketing operations, which may be prematurely or unnecessarily incurred if the commercial launch of a product isabandoned or delayed.Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities.We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include general liability,employee benefits liability, property, umbrella, business interruption, workers’ compensation, product liability, errors and omissions and directors’ andofficers’ insurance. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsuredliability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.34 If we use hazardous materials in a manner that causes injury, we could be liable for damages.Our activities currently require the use of hazardous materials and the handling of patient samples. We cannot eliminate the risk of accidental contaminationor injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be heldliable for any resulting damages, and any liability could exceed our resources or any applicable insurance coverage we may have. Additionally, we aresubject on an ongoing basis to federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specifiedwaste products. We are, or may be in the future, subject to compliance with additional laws and regulations relating to the protection of the environment andhuman health and safety, and including those relating to the handling, transportation and disposal of medical specimens, infectious and hazardous waste andOccupational Safety and Health Administration (“OSHA”), requirements.If we are sued for product liability or errors and omissions liability, we could face substantial liabilities that exceed our resources.The marketing, sale and use of our products could lead to product liability claims if someone were to allege that a product failed to perform as it wasdesigned. We may also be subject to liability for errors in the results we provide to physicians or for a misunderstanding of, or inappropriate reliance upon,the information we provide. For example, if we diagnosed a patient as having an MDRO but such result was a false positive, the patient could beunnecessarily isolated in an in-patient setting or receive inappropriate treatment. We may also be subject to similar types of claims related to products wemay develop in the future. A product liability or errors and omissions liability claim could result in substantial damages and be costly and time consumingfor us to defend. Although we maintain product liability and errors and omissions insurance, we cannot assure you that our insurance would fully protect usfrom the financial impact of defending against these types of claims or any judgments, fines or settlement costs arising out of any such claims. Any productliability or errors and omissions liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securinginsurance coverage in the future. Additionally, any product liability lawsuit could cause injury to our reputation or cause us to suspend sales of our productsand services. The occurrence of any of these events could have an adverse effect on our business and results of operations.Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.We have incurred net losses since inception and do not expect to become profitable in 2017 or for several years thereafter. To the extent that we continue togenerate taxable losses, unused losses will carry forward to offset future taxable income, if any, until such unused losses expire. We may be unable to usethese net operating loss carryforwards (“NOLs”), and certain tax credit carryforwards to offset income before such unused NOLs tax credit carryforwardsexpire. Under Section 382 of the Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in itsequity ownership over a three-year period), the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes to offset its post-changeincome may be further limited. The Merger with AdvanDx resulted in an ownership change for AdvanDx and, accordingly, AdvanDx’s net operating losscarryforwards and certain other tax attributes in U.S. taxing jurisdictions are subject to limitations on their use after the Merger. OpGen’s net operating losscarryforwards may also be subject to limitation as a result of prior shifts in equity ownership and/or the Merger. Additional ownership changes in the futurecould result in additional limitations on our net operating loss carryforwards. Consequently, even if we achieve profitability, we may not be able to utilize amaterial portion of our net operating loss carryforwards and other tax attributes, which could have a material adverse effect on cash flow and results ofoperations. We have not performed an analysis on previous ownership changes. It is possible that we have experienced an ownership change, or that we willexperience an ownership change in the future. We had U.S. federal NOL carryforwards of $151.0 million and research and development tax credits of $2.6million as of December 31, 2016, that may already be or could be limited if we experience an ownership change.We may be adversely affected by the current economic environment and future adverse economic environments.Our ability to attract and retain customers, invest in and grow our business and meet our financial obligations depends on our operating and financialperformance, which, in turn, is subject to numerous factors, including the prevailing economic conditions and financial, business and other factors beyondour control, such as the rate of unemployment, the number of uninsured persons in the United States and inflationary pressures. We cannot anticipate all theways in which the current economic climate and financial market conditions, and those in the future, could adversely impact our business.We are exposed to risks associated with reduced profitability and the potential financial instability of our customers, many of which may be adverselyaffected by volatile conditions in the financial markets. For example, unemployment and underemployment, and the resultant loss of insurance, may decreasethe demand for healthcare services and diagnostic testing. If fewer patients are seeking medical care because they do not have insurance coverage, we mayexperience reductions in revenues, profitability and/or cash flow. In addition, if economic challenges in the United States result in widespread and prolongedunemployment, either regionally or on a national basis, a substantial number of people may become uninsured or underinsured. To the extent such economicchallenges result in less demand for our proprietary tests, our business, results of operations, financial condition and cash flows could be adversely affected.35 Risks Related to Our Securities and Public Company StatusTrading of our common stock is limited, and trading restrictions imposed on us by applicable regulations may further reduce trading in our common stock,making it difficult for our stockholders to sell their shares; and future sales of common stock could reduce our stock price.Trading of our common stock is currently conducted on The NASDAQ Capital Market. The liquidity of our common stock is limited, not only in terms of thenumber of shares that can be bought and sold at a given price, but also as it may be adversely affected by delays in the timing of transactions and reduction insecurity analysts’ and the media’s coverage of us, if at all. As of December 31, 2016, a significant number of the issued and outstanding shares of our commonstock were held by officers, directors and beneficial owners of at least 10% of our outstanding shares, each of whom is subject to certain restrictions withregard to trading our common stock. In addition, Merck GHI became our principal stockholder following the 2016 PIPE financing transaction; as ofDecember 31, 2016 it owns approximately 21% of our outstanding common stock, and has the right to acquire approximately 3.0 million additional sharesupon the exercise of stock purchase warrants, which, if exercised, could put its ownership at approximately 30% of our outstanding shares. These factors mayresult in different prices for our common stock than might otherwise be obtained in a more liquid market and could also result in a larger spread between thebid and asked prices for our common stock. In addition, without a large public float, our common stock is less liquid than the stock of companies withbroader public ownership, and, as a result, the trading prices of our common stock may be more volatile. In the absence of an active public trading market, aninvestor may be unable to liquidate his investment in our common stock. Trading of a relatively small volume of our common stock may have a greaterimpact on the trading price of our stock than would be the case if our public float were larger. We cannot predict the prices at which our common stock willtrade in the future, if at all.Directors, executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they may make decisionsthat you do not consider to be in the best interests of our stockholders.Our directors, executive officers, principal stockholders and affiliated entities beneficially own, in the aggregate, approximately 59% of our outstandingcommon stock as of the date of this filing. As a result, if some or all of them acted together, they would have the ability to exert substantial influence over theelection of our Board of Directors and the outcome of issues requiring approval by our stockholders. This concentration of ownership may also have theeffect of delaying or preventing a change in control of the Company that may be favored by other stockholders. This could prevent transactions in whichstockholders might otherwise recover a premium for their shares over current market prices.The exercise of outstanding common stock purchase warrants and stock options will have a dilutive effect on the percentage ownership of our capitalstock by existing stockholders.As of December 31, 2016, we had outstanding warrants to acquire 10,506,524 shares of our common stock, and stock options to acquire 2,977,660 shares ofour common stock. The expiration of the term of such options and warrants range from August 2017 to December 2026. A significant number of suchwarrants are out of the money, but the holders have the right to effect a cashless exercise of such warrants. If a significant number of such warrants and stockoptions are exercised by the holders, the percentage of our common stock owned by our existing stockholders will be diluted.We will incur increased costs and demands on management as a result of compliance with laws and regulations applicable to public companies, whichcould harm our operating results.As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company, including costs associatedwith public company reporting requirements. In addition, the Sarbanes-Oxley Act of 2002 and the Dodd-Frank Act of 2010, as well as rules implemented bythe SEC and The NASDAQ Stock Market, impose a number of requirements on public companies, including with respect to corporate governance practices.Our management and other personnel will need to devote a substantial amount of time to these compliance and disclosure obligations. Moreover, these rulesand regulations will increase our legal, accounting and financial compliance costs and will make some activities more time-consuming and costly. We alsoexpect that it will be more expensive for us to obtain director and officer liability insurance.Changes in, or interpretations of, accounting rules and regulations could result in unfavorable accounting changes or require us to change ourcompensation policies.Accounting methods and policies for diagnostic companies, including policies governing revenue recognition, research and development and relatedexpenses and accounting for stock-based compensation, are subject to further review, interpretation and guidance from relevant accounting authorities,including the SEC. Changes to, or interpretations of, accounting methods or policies may require us to reclassify, restate or otherwise change or revise ourfinancial statements, including those contained in this Annual Report. Restatement of our financial statements could have a negative impact on our business.36 If we are unable to implement and maintain effective internal control over financial reporting, investors may lose confidence in the accuracy andcompleteness of our reported financial information and the market price of our common stock may be negatively affected.As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal control.Section 404 of the Sarbanes-Oxley Act of 2002 requires that we evaluate and determine the effectiveness of our internal control over financial reporting andprovide a management report on internal control over financial reporting. If we have a material weakness in our internal control over financial reporting, wemay not detect errors on a timely basis and our financial statements may be materially misstated.When we are no longer an emerging growth company, our independent registered public accounting firm will be required to issue an attestation report on theeffectiveness of our internal control over financial reporting. Even if our management concludes that our internal control over financial reporting is effective,our independent registered public accounting firm may conclude that there are material weaknesses with respect to our internal controls or the level at whichour internal controls are documented, designed, implemented or reviewed.When we are no longer an emerging growth company, if our auditors were to express an adverse opinion on the effectiveness of our internal control overfinancial reporting because we had one or more material weaknesses, investors could lose confidence in the accuracy and completeness of our financialdisclosures, which could cause the price of our common stock to decline. Internal control deficiencies could also result in a restatement of our financialresults in the future.We are an emerging growth company and may elect to comply with reduced public company reporting requirements applicable to emerging growthcompanies, which could make our common stock less attractive to investors.We are an emerging growth company, as defined under the Securities Act. We will remain an emerging growth company for up to five years, although if ourrevenue exceeds $1 billion in any fiscal year before that time, we would cease to be an emerging growth company as of the end of that fiscal year. In addition,if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business day of our second fiscal quarter of anyfiscal year before the end of that five-year period, we would cease to be an emerging growth company as of December 31 of that year. As an emerging growthcompany, we may choose to take advantage of exemptions from various reporting requirements applicable to certain other public companies, including notbeing required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced financial statement and financial-related disclosures, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from therequirement of holding a nonbinding advisory vote on executive compensation and obtaining stockholder approval of any golden parachute payments notpreviously approved by our stockholders. We cannot predict whether investors will find our common stock less attractive if we choose to rely on any of theseexemptions. If some investors find our common stock less attractive as a result of any choices to reduce future disclosure we may make, there may be a lessactive trading market for our common stock and our stock price may be more volatile.Risks Related to Regulation of Our BusinessIf we fail to comply with federal, state and foreign laboratory licensing requirements, we could lose the ability to perform our tests or experiencedisruptions to our business.We are subject to CLIA for our Acuitas MDRO tests, a federal law that regulates clinical laboratories that perform testing on specimens derived from humansfor the purpose of providing information for the diagnosis, prevention or treatment of disease. CLIA regulations mandate specific standards in the areas ofpersonnel qualifications, administration and participation in proficiency testing, patient test management and quality assurance. CLIA certification is alsorequired in order for us to be eligible to bill state and federal healthcare programs, as well as many private third-party payors. To renew these certifications, weare subject to survey and inspection every two years. Moreover, CLIA inspectors may make random inspections of our clinical reference laboratories.We are also required to maintain state licenses to conduct testing in our laboratories. Maryland law requires that we maintain a state license and establishesstandards for the day-to-day operation of our clinical reference laboratory in Gaithersburg, including the training and skills required of personnel and qualitycontrol matters. In addition, our clinical reference laboratory is required to be licensed on a test-specific basis by New York State. New York law alsomandates proficiency testing for laboratories licensed under New York state law, regardless of whether such laboratories are located in New York. Moreover,several other states including California, Pennsylvania, and Florida require that we hold licenses to test samples from patients in those states. Other states mayadopt similar requirements in the future.37 If we were to lose, or have restrictions imposed on, our CLIA certificate or Maryland license for our Gaithersburg laboratory, whether as a result of revocation,suspension or limitation, we would no longer be able to perform our test products, which would eliminate our primary source of revenue and harm ourbusiness. If we cannot secure a license from New York or from other states where we are required to hold licenses, we will not be able to test specimens fromthose states.A number of the rapid diagnostic products are regulated by the FDA and non-U.S. regulatory authorities. If we or our suppliers fail to comply withongoing FDA, or other foreign regulatory authority, requirements, or if we experience unanticipated problems with the products, these products could besubject to restrictions or withdrawal from the market.We do not have significant experience in complying with the rules and regulations of the FDA and foreign regulatory authorities. The rapid diagnosticproducts regulated as medical devices, and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities forsuch products, are subject to continued regulatory review, oversight and periodic inspections by the FDA and other domestic and foreign regulatory bodies.In particular, we and our suppliers are required to comply with FDA’s QSR and ISO regulations for the manufacture, labeling, distribution and promotion ofthe QuickFISH products and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance,labeling, packaging, storage and shipping of any product for which we obtain clearance or approval. Regulatory bodies, such as the FDA, enforce the QSRand other regulations through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administeredby the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues,could result in, among other things, any of the following enforcement actions: (1) untitled letters, warning letters, fines, injunctions, consent decrees and civilpenalties; (2) unanticipated expenditures to address or defend such actions; (3) customer notifications for repair, replacement and refunds; (4) recall,detention or seizure of our products; (5) operating restrictions or partial suspension or total shutdown of production; (6) refusing or delaying our requests for510(k) clearance or premarket approval of new products or modified products; (7) operating restrictions; (8) withdrawing 510(k) clearances or PMA approvalsthat have already been granted; (9) refusal to grant export approval for our products; or (10) criminal prosecution.If any of these actions were to occur it could harm our reputation and cause our product sales and profitability to suffer and may prevent us from generatingrevenue. Furthermore, if any of our key component suppliers are not in compliance with all applicable regulatory requirements we may be unable to produceour products on a timely basis and in the required quantities, if at all.We are also subject to periodic inspections by the FDA to determine compliance with the FDA’s requirements, including primarily the quality systemregulations and medical device reporting regulations. The results of these inspections can include inspectional observations on FDA’s Form 483, warningletters, or other forms of enforcement. Since 2009, the FDA has significantly increased its oversight of companies subject to its regulations, by hiring newinvestigators and stepping up inspections of manufacturing facilities. The FDA has recently also significantly increased the number of warning letters issuedto companies. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, or that any of our FDA-cleared products areineffective or pose an unreasonable health risk, the FDA could take a number of regulatory actions, which could materially adversely affect our business.Some of the clearances obtained are subject to limitations on the intended uses for which the product may be marketed, which can reduce our potential tosuccessfully commercialize the product and generate revenue from the product. If the FDA determines that our promotional materials, labeling, training orother marketing or educational activities constitute promotion of an unapproved use, it could request that we cease or modify our training or promotionalmaterials or subject us to regulatory enforcement actions. It is also possible that other federal, state or foreign enforcement authorities might take action ifthey consider our training or other promotional materials to constitute promotion of an unapproved use, which could result in significant fines or penaltiesunder other statutory authorities, such as laws prohibiting false claims for reimbursement.In addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we mustcomply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products. Later discovery ofpreviously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency,manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products ormanufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of anymedical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminalpenalties which would adversely affect our business, operating results and prospects.If we were to lose, or have restrictions imposed on, FDA clearances received to date, our business, operations, financial condition and results of operationswould likely be significantly adversely affected.38 If the FDA were to begin regulating our laboratory tests, we could incur substantial costs and delays associated with trying to obtain premarket clearanceor other approvals.Clinical laboratory tests, like our Acuitas MDRO Gene Test, are regulated under CLIA, as well as by applicable state laws. Historically, most LDTs were notsubject to FDA regulations applicable to medical devices, although reagents, instruments, software or components provided by third parties and used toperform LDTs may be subject to regulation. The FDA defines the term “laboratory developed test” as an IVD test that is intended for clinical use anddesigned, manufactured and used within a single laboratory. We believe that our Acuitas MDRO test products are LDTs. Until 2014, the FDA exercisedenforcement discretion such that it did not enforce provisions of the Food, Drug, and Cosmetic Act (the “FDA Act”) with respect to LDTs. In July 2014, dueto the increased proliferation of LDTs for complex diagnostic testing and concerns with several high-risk LDTs related to lack of evidentiary support forclaims, erroneous results and falsification of data, the FDA issued guidance that, when finalized, would adopt a risk-based framework that would increaseFDA oversight of LDTs. As part of this developing framework, FDA issued draft guidance in October 2014, informing manufacturers of LDTs of its intent tocollect information from laboratories regarding their current LDTs and newly developed LDTs through a notification process. The FDA will use thisinformation to classify LDTs and to prioritize enforcement of premarket review requirements for categories of LDTs based on risk, using a public process.Specifically, the FDA plans to use advisory panels to provide recommendations to the agency on LDT risks, classification and prioritization of enforcementof applicable regulatory requirements on certain categories of LDTs, as appropriate.We cannot provide any assurance that FDA regulation, including premarket review, will not be required in the future for our tests, whether through additionalguidance or regulations issued by the FDA, new enforcement policies adopted by the FDA or new legislation enacted by Congress. It is possible thatlegislation will be enacted into law, regulations could be promulgated or guidance could be issued by the FDA which may result in increased regulatoryburdens for us to continue to offer our tests or to develop and introduce new tests. We cannot predict the timing or content of future legislation enacted,regulations promulgated or guidance issued regarding LDTs, or how it will affect our business.If FDA premarket review, including clearance or approval, is required for our Acuitas MDRO test products or any of our future tests (either alone or togetherwith sample collection devices), products or services we may develop, or we decide to voluntarily pursue FDA clearance or approval, we may be forced tostop selling our tests while we work to obtain such FDA clearance or approval. Our business would be negatively affected until such review was completedand clearance to market or approval was obtained. The regulatory process may involve, among other things, successfully completing additional clinicalstudies and submitting premarket notification or filing a premarket approval application with the FDA. If premarket review is required by the FDA or if wedecide to voluntarily pursue FDA premarket review of our tests, there can be no assurance that our Acuitas MDRO Gene Test or any tests, products or serviceswe may develop in the future will be cleared or approved on a timely basis, if at all, nor can there be assurance that labeling claims will be consistent with ourcurrent claims or adequate to support continued adoption of our tests. If our tests are allowed to remain on the market but there is uncertainty in themarketplace about our tests, if we are required by the FDA to label them investigational, or if labeling claims the FDA allows us to make are limited, ordersmay decline. Ongoing compliance with FDA regulations would increase the cost of conducting our business, and subject us to heightened regulation by theFDA and penalties for failure to comply with these requirements.If we are required to but fail to maintain regulatory approvals and clearances, or are unable to obtain, or experience significant delays in obtaining, FDAclearances or approvals for our products or product enhancements, our ability to commercially distribute and market our products could suffer.If the FDA determines that enforcement discretion is not appropriate or that LDTs are generally subject to FDA regulation and that premarket review,including clearance or approval, is required for our Acuitas MDRO Gene Test or any of our future tests, diagnostic test kits that we may develop, or otherproducts that would be classified as medical devices, the process of obtaining regulatory clearances or approvals to market a medical device can be costlyand time consuming, and we may not be able to obtain these clearances or approvals on a timely basis, if at all. In particular, the FDA permits commercialdistribution of a new medical device only after the device has received clearance under Section 510(k) of the FDA Act, or is the subject of an approved PMA,unless the device is specifically exempt from those requirements. The FDA will clear marketing of a lower risk medical device through the 510(k) process ifthe manufacturer demonstrates that the new product is substantially equivalent to other 510(k)-cleared products. High risk devices deemed to pose thegreatest risk, such as life-sustaining, life-supporting, or implantable devices, or devices not deemed substantially equivalent to a previously cleared device,require the approval of a PMA. The PMA process is more costly, lengthy and uncertain than the 510(k) clearance process. A PMA application must besupported by extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and labeling data, to demonstrate to the FDA’ssatisfaction the safety and efficacy of the device for its intended use. Our currently commercialized products have not received FDA clearance or approval, asthey are marketed under the FDA’s enforcement discretion for LDTs or are class I medical devices, which are exempt from the requirement for FDA clearanceor approval.39 Our failure to comply with U.S. federal, state and foreign governmental regulations could lead to the issuance of warning letters or untitled letters, theimposition of injunctions, suspensions or loss of regulatory clearance or approvals, product recalls, termination of distribution, product seizures or civilpenalties. In the most extreme cases, criminal sanctions or closure of our manufacturing facility are possible.Modifications to our marketed products may require new 510(k) clearances or PMA approvals, or may require us to cease marketing or recall themodified products until clearances or approvals are obtained.If we are required to obtain 510(k) clearance or PMA approval for any of our current or future products, any modification to those products would requireadditional clearances or approvals. Modifications to a 510(k)-cleared device that could significantly affect its safety or efficacy, or that would constitute amajor change in its intended use, requires a new 510(k) clearance or, possibly, a PMA. The FDA requires every manufacturer to make this determination in thefirst instance, but the FDA may review the manufacturer’s decision. The FDA may not agree with our decisions regarding whether new clearances or approvalsare necessary. If the FDA requires us to seek 510(k) clearance or a PMA for any modification to a previously cleared product, we may be required to ceasemarketing and distributing, or to recall the modified product until we obtain such clearance or approval, and we may be subject to significant regulatory finesor penalties. Further, our products could be subject to recall if the FDA determines, for any reason, that our products are not safe or effective. Any recall orFDA requirement that we seek additional approvals or clearances could result in significant delays, fines, increased costs associated with modification of aproduct, loss of revenue and potential operating restrictions imposed by the FDA.There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our future products, and failure to obtain necessary clearances orapprovals for our future products would adversely affect our ability to grow our business.Some of our future products may require 510(k) clearance from the FDA. Other products, potentially, could require PMA approval. In addition, some of ournew products may require clinical trials to support regulatory approval and we may not successfully complete these clinical trials. The FDA may not approveor clear these products for the indications that are necessary or desirable for successful commercialization. Indeed, the FDA may refuse our requests for 510(k)clearance or premarket approval of new products. Failure to receive a required clearance or approval for our new products would have an adverse effect on ourability to expand our business.Our products may in the future be subject to product recalls that could harm our reputation, business and financial results.The FDA and similar foreign governmental authorities have the authority to require the recall of regulated products in the event of material deficiencies ordefects in design or manufacture. In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is a reasonableprobability that the device would cause serious injury or death. In addition, foreign governmental bodies have the authority to require the recall of ourproducts in the event of material deficiencies or defects in design or manufacture. Manufacturers may, under their own initiative, recall a product if anymaterial deficiency in a device is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of componentfailures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial andfinancial resources and have an adverse effect on our financial condition and results of operations. The FDA requires that certain classifications of recalls bereported to FDA within 10 working days after the recall is initiated. Companies are required to maintain certain records of recalls, even if they are notreportable to the FDA. We may initiate voluntary recalls involving our products in the future that we determine do not require notification of the FDA. If theFDA disagrees with our determinations, they could require us to report those actions as recalls. A future recall announcement could harm our reputation withcustomers and negatively affect our sales. In addition, the FDA could take enforcement action for failing to report the recalls when they were conducted.If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reportingregulations, which can result in voluntary corrective actions or agency enforcement actions.Under the FDA medical device reporting regulations, medical device and LDT manufacturers are required to report to the FDA information that a device orLDT has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death orserious injury if the malfunction of the device or one of our similar devices were to recur. If we fail to report these events to the FDA within the requiredtimeframes, or at all, FDA could take enforcement action against us. Any such adverse event involving our products also could result in future voluntarycorrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whethervoluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operatingour business, and may harm our reputation and financial results.40 We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or "off-label" uses.We believe that our Acuitas MDRO test products are LDTs, subject to the FDA’s enforcement discretion. To remain within the FDA’s enforcement discretion,we are restricted in the ways we can promote and market our products. Furthermore, certain of our future products, including specimen transport containers wemay develop such as Grow on the Go, might be regulated as class I medical devices for which premarket clearance or approval is not required, subject tocertain limitations. We believe that our promotional activities for our products fall within the scope of the FDA’s enforcement discretion and applicablepremarket exemptions. However, the FDA could disagree and require us to stop promoting our products in certain ways unless and until we obtain FDAclearance or approval for them. In addition, because our products are not currently cleared or approved by the FDA, if the FDA determines that ourpromotional materials constitute promotion of a use for which premarket clearance or approval is required, it could request that we modify our promotionalmaterials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine andcriminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional materialsto constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibitingfalse claims for reimbursement. In that event, our reputation could be damaged and adoption of the products would be impaired.We may generate a larger portion of our future revenue internationally and would then be subject to increased risks relating to international activitieswhich could adversely affect our operating results.We believe that a portion of our future revenue growth will come from international sources as we implement and expand overseas operations. Engaging ininternational business involves a number of difficulties and risks, including: •required compliance with existing and changing foreign health care and other regulatory requirements and laws, such as those relating topatient privacy; •required compliance with anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act (“FCPA”), and U.K. Bribery Act, data privacyrequirements, labor laws and anti-competition regulations; •export or import restrictions; •various reimbursement and insurance regimes; •laws and business practices favoring local companies; •longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; •political and economic instability; •potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and other trade barriers; •foreign exchange controls; •difficulties and costs of staffing and managing foreign operations; and •difficulties protecting or procuring intellectual property rights.As we expand internationally, our results of operations and cash flows would become increasingly subject to fluctuations due to changes in foreign currencyexchange rates. Our expenses are generally denominated in the currencies in which our operations are located, which is in the United States. If the value ofthe U.S. dollar increases relative to foreign currencies in the future, in the absence of a corresponding change in local currency prices, our future revenuecould be adversely affected as we convert future revenue from local currencies to U.S. dollars. If we dedicate resources to our international operations and areunable to manage these risks effectively, our business, operating results and prospects will suffer.We face the risk of potential liability under the FCPA for past international distributions of products and to the extent we distribute products or otherwiseoperate internationally in the future.In the past, we have distributed certain of our products internationally, and in the future we may distribute our products internationally and possibly engagein additional international operations. The FCPA prohibits companies such as us from engaging, directly or indirectly, in making payments to foreigngovernment and political officials for the purpose of obtaining or retaining business or securing any other improper advantage, including, among otherthings, the distribution of products and other international business operations. Like other U.S. companies operating abroad, we may face liability under theFCPA if we, or third parties we have used to distribute our products or otherwise advance our international business, have violated the FCPA. Any violationsof these laws, or41 allegations of such violations, could disrupt our operations, involve significant management distraction, involve significant costs and expenses, includinglegal fees, and could result in a material adverse effect on our business, prospects, financial condition or results of operations. We could also suffer severepenalties, including criminal and civil penalties, disgorgement and other remedial measures.Risks Related to Compliance with Healthcare and Other RegulationsChanges in healthcare policy, including legislation reforming the U.S. healthcare system, may have a material adverse effect on our financial conditionand operations.In March 2010, President Obama signed into law both the Patient Protection and Affordable Care Act (the “Affordable Care Act”) and the reconciliation lawknown as Health Care and Education Reconciliation Act (the “Reconciliation Act,” and, with the Affordable Care Act, the “2010 Health Care ReformLegislation”). The constitutionality of the 2010 Health Care Reform Legislation was confirmed twice by the Supreme Court of the United States. The 2010Health Care Reform Legislation has changed the existing state of the health care system by expanding coverage through voluntary state Medicaid expansion,attracting previously uninsured persons through the new health care insurance exchanges and by modifying the methodology for reimbursing medicalservices, drugs and devices. Both Congressional leaders and newly elected President Trump have announced plans to repeal or modify the 2010 Health CareReform Legislation. At this time the Company is not certain as to the impact of federal health care legislation on its business.The 2010 Health Care Reform Legislation subjects manufacturers of medical devices to an excise tax of 2.3% on certain U.S. sales of medical devicesbeginning in January 2013. This excise tax was suspended in December 2015 for two years, and we anticipate that this may be repealed. If eventuallyimplemented, this excise tax will likely increase our expenses in the future.Further, the 2010 Health Care Reform Legislation includes the Open Payments Act (formerly referred to as the Physician Payments Sunshine Act), which, inconjunction with its implementing regulations, requires certain manufacturers of certain drugs, biologics, and devices that are reimbursed by Medicare,Medicaid and the Children’s Health Insurance Program to report annually certain payments or “transfers of value” provided to physicians and teachinghospitals and to report annually ownership and investment interests held by physicians and their immediate family members during the preceding calendaryear. We have provided reports under the Open Payments Act to the CMS since 2013. The failure to report appropriate data accurately, timely, andcompletely could subject us to significant financial penalties. Other countries and several states currently have similar laws and more may enact similarlegislation. We cannot predict whether future healthcare initiatives will be implemented at the federal or state level or in countries outside of the United States in whichwe may do business, or the effect any future legislation or regulation will have on us. The taxes imposed by the new federal legislation and the expansion ingovernment’s effect on the United States healthcare industry may result in decreased profits to us, which may adversely affect our business, financialcondition and results of operations.Failure in our information technology, storage systems or our digital platform technology could significantly disrupt our operations and our research anddevelopment efforts, which could adversely impact our revenues, 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 systems, whichsupport our operations and our research and development efforts, as well as our storage systems and our analyzers. Due to the sophisticated nature of thetechnology we use in our products and service offerings, including our Acuitas Lighthouse services, we are substantially dependent on our informationtechnology systems. information technology systems are vulnerable to damage from a variety of sources, including telecommunications or network failures,malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable tophysical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionary measures we have taken to preventunanticipated problems that could affect our information technology systems, sustained or repeated system failures that interrupt our ability to generate andmaintain data, and in particular to operate our digital immunoassay platform, could adversely affect our ability to operate our business. Any interruption inthe operation of our digital immunoassay platform, due to information technology system failures, part failures or potential disruptions in the event we arerequired to relocate our instruments within our facility or to another facility, could have an adverse effect on our operations.Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing criticalinformation and expose us to liability, which could adversely affect our business and our reputation.In the ordinary course of our business, we collect and store sensitive data, including legally protected health information and personally identifiableinformation about our customers and their patients. We also store sensitive intellectual property and other proprietary business information, including that ofour customers. We manage and maintain our applications and data utilizing a combination of on-site42 systems and cloud-based data center systems. These applications and data encompass a wide variety of business critical information, including research anddevelopment information, commercial information and business and financial information.We face four primary risks relative to protecting this critical information: loss of access risk, inappropriate disclosure risk, inappropriate modification risk andthe risk of our being unable to identify and audit our controls over the first three risks.We are highly dependent on information technology networks and systems, including the Internet, to securely process, transmit and store this criticalinformation. Security breaches of this infrastructure, including physical or electronic break-ins, computer viruses, attacks by hackers and similar breaches, cancreate system disruptions, shutdowns or unauthorized disclosure or modification of confidential information. The secure processing, storage, maintenanceand transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting suchinformation. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology andinfrastructure may be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance or other disruptions.A security breach or privacy violation that leads to disclosure or modification of or prevents access to consumer information (including personallyidentifiable information or protected health information) could harm our reputation, compel us to comply with disparate state breach notification laws,require us to verify the correctness of database contents and otherwise subject us to liability under laws that protect personal data, resulting in increased costsor loss of revenue. If we are unable to prevent such security breaches or privacy violations or implement satisfactory remedial measures, our operations couldbe disrupted, and we may suffer loss of reputation, financial loss and other regulatory penalties because of lost or misappropriated information, includingsensitive consumer data. In addition, these breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead toincreased harm of the type described above.Any such breach or interruption could compromise our networks, and the information stored there could be inaccessible or could be accessed byunauthorized parties, publicly disclosed, lost or stolen. Any such interruption in access, improper access, disclosure or other loss of information could resultin legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the federal HIPAA and regulatory penalties.Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to perform tests, provide test results, bill facilities orpatients, process claims and appeals, provide customer assistance services, conduct research and development activities, collect, process and prepareCompany financial information, provide information about our current and future solutions and other patient and clinician education and outreach effortsthrough our website, and manage the administrative aspects of our business and damage our reputation, any of which could adversely affect our business.Any such breach could also result in the compromise of our trade secrets and other proprietary information, which could adversely affect our competitiveposition.In addition, the interpretation and application of consumer, health-related, privacy and data protection laws in the U.S. and elsewhere are often uncertain,contradictory and in flux. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices. If so, this couldresult in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. Complying with these variouslaws could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business.Payments for our tests and other services could decline because of factors beyond our control.If hospital patient volumes drop as a result of severe economic conditions, or other unforeseen changes in healthcare provision or affordability, individualhospitals and health systems may be less willing to invest in our products and services. In addition, state and federal funds that are anticipated to be investedin the National Strategy for Combating Antibiotic-Resistant Bacteria could be reduced. If such funds are reduced, the market for our products would beimpacted, which may affect our ability to generate revenues.43 If we accept payment from federal and state healthcare programs in the future, we will be subject to enforcement actions involving false claims, kickbacks,physician self-referral or other federal or state fraud and abuse laws, and we could incur significant civil and criminal sanctions and loss ofreimbursement, which would hurt our business.The government has made enforcement of the false claims, anti-kickback, physician self-referral and various other fraud and abuse laws a major priority. Inmany instances, private whistleblowers also are authorized to enforce these laws even if government authorities choose not to do so. Several clinicaldiagnostic laboratories and members of their management have been the subject of this enforcement scrutiny, which has resulted in very significant civil andcriminal settlement payments. In most of these cases, private whistleblowers brought the allegations to the attention of federal enforcement agencies. The riskof our being found in violation of these laws and regulations is increased by the fact that some of the laws and regulations have not been fully interpreted bythe regulatory authorities or the courts, and their provisions are open to a variety of interpretations. In the event we begin accepting reimbursement fromfederal or state healthcare programs for our tests, we would be subject to the following laws: •the federal Anti-Kickback Statute, which constrains certain marketing practices, educational programs, pricing policies and relationships withhealthcare providers or other entities by prohibiting, among other things, soliciting, receiving, offering or paying remuneration, directly orindirectly, to induce or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program,such as the Medicare and Medicaid programs; •federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities fromknowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third party payors that are false orfraudulent; •federal physician self-referral laws, such as the Stark Law, which prohibit a physician from making a referral to a provider of certain healthservices with which the physician or the physician’s family member has a financial interest, and prohibit submission of a claim forreimbursement pursuant to a prohibited referral; and •state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or servicesreimbursed by any third party payor, including commercial insurers, many of which differ from each other in significant ways and may not havethe same effect, thus complicating compliance efforts.If we or our operations, are found to be in violation of any of these laws and regulations, we may be subject to penalties, including civil and criminalpenalties, damages, fines, exclusion from participation in U.S. federal or state healthcare programs, such as Medicare and Medicaid, and the curtailment orrestructuring of our operations. We have compliance policies and are in the process of adopting a written compliance plan based on the HHS Office of theInspector General guidance set forth in its model compliance plan for clinical laboratories, and federal and state fraud and abuse laws. We will monitorchanges in government enforcement, particularly in these areas, as we grow and expand our business. Any action against us for violation of these laws, even ifwe successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our businessand hurt our reputation. If we were excluded from participation in U.S. federal healthcare programs, we would not be able to receive, or to sell our tests toother parties who receive reimbursement from Medicare, Medicaid and other federal programs, and that could have a material adverse effect on our business.Risks Related to Our Intellectual PropertyIf we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.In the future, we may license third-party technology to develop or commercialize new products. In return for the use of a third party’s technology, we mayagree to pay the licensor royalties based on sales of our solutions. Royalties are a component of cost of services and affect the margins on our products. Wemay also need to negotiate licenses to patents and patent applications after introducing a commercial product. Our business may suffer if we are unable toenter into the necessary licenses on acceptable terms, or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the termsof the license or fail to prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable.If we are unable to protect our intellectual property effectively, our business would be harmed.We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions toprotect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep anycompetitive advantage. If we fail to protect our intellectual property, third parties may be able to compete more effectively against us and we may incursubstantial litigation costs in our attempts to recover or restrict use of our intellectual property.44 In July 2015, we issued a senior secured promissory note, in the principal amount of $1 million, to Merck GHI. Such Note is secured by a lien on our assets,including our intellectual property assets. If we default on our payment obligations under the Note, Merck GHI has the right to control the disposition of ourassets, including our intellectual property assets. If such default occurs, and our intellectual property assets are sold or licensed, our business could bematerially adversely affected.We apply for patents covering our products and technologies and uses thereof, as we deem appropriate, however we may fail to apply for patents on importantproducts and technologies in a timely fashion or at all, or we may fail to apply for patents in potentially relevant jurisdictions. It is possible that none of ourpending patent applications will result in issued patents in a timely fashion or at all, and even if patents are granted, they may not provide a basis forintellectual property protection of commercially viable products, may not provide us with any competitive advantages, or may be challenged and invalidatedby third parties. It is possible that others will design around our current or future patented technologies. We may not be successful in defending anychallenges made against our patents or patent applications. Any successful third-party challenge to our patents could result in the unenforceability orinvalidity of such patents and increased competition to our business. The outcome of patent litigation can be uncertain and any attempt by us to enforce ourpatent rights against others may not be successful, or, if successful, may take substantial time and result in substantial cost, and may divert our efforts andattention from other aspects of our business.The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principlesremain unresolved. No consistent policy regarding the breadth of claims allowed in such companies’ patents has emerged to date in the United States orelsewhere. Courts frequently render opinions in the biotechnology field that may affect the patentability of certain inventions or discoveries, includingopinions that may affect the patentability of methods for analyzing or comparing DNA.In particular, the patent positions of companies engaged in the development and commercialization of genomic diagnostic tests, like ours, are particularlyuncertain. Various courts, including the U.S. Supreme Court, have recently rendered decisions that affect the scope of patentability of certain inventions ordiscoveries relating to certain diagnostic tests and related methods. These decisions state, among other things, that patent claims that recite laws of nature (forexample, the relationship between blood levels of certain metabolites and the likelihood that a dosage of a specific drug will be ineffective or cause harm) arenot themselves patentable. What constitutes a law of nature is uncertain, and it is possible that certain aspects of genetic diagnostics tests would beconsidered natural laws. Accordingly, the evolving case law in the United States may adversely affect our ability to obtain patents and may facilitate third-party challenges to any owned and licensed patents. The laws of some foreign countries do not protect intellectual property rights to the same extent as thelaws of the United States, and we may encounter difficulties protecting and defending such rights in foreign jurisdictions. The legal systems of many othercountries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could makeit difficult for us to stop the infringement of our patents in such countries. Proceedings to enforce our patent rights in foreign jurisdictions could result insubstantial cost and divert our efforts and attention from other aspects of our business.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. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. We may not develop additionalproprietary products, methods and technologies that are patentable.In addition to pursuing patents on our technology, we take steps to protect our intellectual property and proprietary technology by entering into agreements,including confidentiality agreements, non-disclosure agreements and intellectual property assignment agreements, with our employees, consultants,academic institutions, corporate partners and, when needed, our advisors. Such agreements may not be enforceable or may not provide meaningful protectionfor our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not beable to prevent such unauthorized disclosure. If we are required to assert our rights against such party, it could result in significant cost and distraction.Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. Ifwe were to enforce a claim that a third party had illegally obtained and was using our trade secrets, it would be expensive and time consuming, and theoutcome would be unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets.We may also be subject to claims that our employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of thirdparties, or to claims that we have improperly used or obtained such trade secrets. Litigation may be necessary to defend against these claims. If we fail indefending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights and face increased competition to ourbusiness. A loss of key research personnel work product could hamper or prevent our ability to commercialize potential products, which could harm ourbusiness. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.45 Further, competitors could attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe ourintellectual property rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectualproperty rights. Others may independently develop similar or alternative products and technologies or replicate any of our products and technologies. If ourintellectual property does not adequately protect us against competitors’ products and methods, our competitive position could be adversely affected, ascould our business.We have not yet registered certain of our trademarks in all of our potential markets. If we apply to register these trademarks, our applications may not beallowed for registration in a timely fashion or at all, and our registered trademarks may not be maintained or enforced. In addition, opposition or cancellationproceedings may be filed against our trademark applications and registrations, and our trademarks may not survive such proceedings. If we do not secureregistrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.To the extent our intellectual property offers inadequate protection, or is found to be invalid or unenforceable, we would be exposed to a greater risk of directcompetition. If our intellectual property does not provide adequate coverage of our competitors’ products, our competitive position could be adverselyaffected, as could our business. Both the patent application process and the process of managing patent disputes can be time consuming and expensive.We may be involved in litigation related to intellectual property, which could be time-intensive and costly and may adversely affect our business, operatingresults or financial condition.We may receive notices of claims of direct or indirect infringement or misappropriation or misuse of other parties’ proprietary rights from time to time. Someof these claims may lead to litigation. We cannot assure you that we will prevail in such actions, or that other actions alleging misappropriation or misuse byus of third-party trade secrets, infringement by us of third-party patents and trademarks or other rights, or the validity of our patents, trademarks or otherrights, will not be asserted or prosecuted against us.We might not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first to filepatent applications for these inventions. To determine the priority of these inventions, we may have to participate in interference proceedings, derivationproceedings, or other post-grant proceedings declared by the United States Patent and Trademark Office that could result in substantial cost to us. Noassurance can be given that other patent applications will not have priority over our patent applications. In addition, recent changes to the patent laws of theUnited States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain.Furthermore, if third parties bring these proceedings against our patents, we could experience significant costs and management distraction.Litigation may be necessary for us to enforce our patent and proprietary rights or to determine the scope, coverage and validity of the proprietary rights ofothers. The outcome of any litigation or other proceeding is inherently uncertain and might not be favorable to us, and we might not be able to obtainlicenses to technology that we require on acceptable terms or at all. Further, we could encounter delays in product introductions, or interruptions in productsales, as we develop alternative methods or products. In addition, if we resort to legal proceedings to enforce our intellectual property rights or to determinethe validity, scope and coverage of the intellectual property or other proprietary rights of others, the proceedings could be burdensome and expensive, even ifwe were to prevail. Any litigation that may be necessary in the future could result in substantial costs and diversion of resources and could have a materialadverse effect on our business, operating results or financial condition.As we move into new markets and applications for our products, incumbent participants in such markets may assert their patents and other proprietary rightsagainst us as a means of slowing our entry into such markets or as a means to extract substantial license and royalty payments from us. Our competitors andothers may now and, in the future, have significantly larger and more mature patent portfolios than we currently have. In addition, future litigation mayinvolve patent holding companies or other adverse patent owners who have no relevant product revenue and against whom our own patents may providelittle or no deterrence or protection. Therefore, our commercial success may depend in part on our non-infringement of the patents or proprietary rights ofthird parties. Numerous significant intellectual property issues have been litigated, and will likely continue to be litigated, between existing and newparticipants in our existing and targeted markets and competitors may assert that our products infringe their intellectual property rights as part of a businessstrategy to impede our successful entry into or growth in those markets. Third parties may assert that we are employing their proprietary technology withoutauthorization. In addition, our competitors and others may have patents or may in the future obtain patents and claim that making, having made, using,selling, offering to sell or importing our products infringes these patents. We could incur substantial costs and divert the attention of our management andtechnical personnel in defending against any of these claims. Parties making claims against us may be able to obtain injunctive or other relief, which couldblock our ability to develop, commercialize and sell products, and could result in the award of substantial damages against us. In the event of a successfulclaim of infringement against us, we may be required to pay damages and ongoing royalties, and obtain one or more licenses from third parties, or beprohibited from selling certain products. We may not be able to obtain these licenses on acceptable terms, if at all. We could incur substantial costs related toroyalty payments for licenses obtained from third parties, which could negatively affect our46 financial results. In addition, we could encounter delays in product introductions while we attempt to develop alternative methods or products to avoidinfringing third-party patents or proprietary rights. Defense of any lawsuit or failure to obtain any of these licenses could prevent us from commercializingproducts, and the prohibition of sale of any of our products could materially affect our business and our ability to gain market acceptance for our products.Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of ourconfidential information could be compromised by disclosure during this type of litigation. In addition, during the course of this kind of litigation, therecould be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceivethese results to be negative, it could have a substantial adverse effect on the price of our common stock.In addition, our agreements with some of our customers, suppliers or other entities with whom we do business require us to defend or indemnify these partiesto the extent they become involved in infringement claims, including the types of claims described above. We could also voluntarily agree to defend orindemnify third parties in instances where we are not obligated to do so if we determine it would be important to our business relationships. If we are requiredor agree to defend or indemnify third parties in connection with any infringement claims, we could incur significant costs and expenses that could adverselyaffect our business, operating results, or financial condition.Item 1B. Unresolved Staff CommentsNone.Item 2. PropertiesThe Company leases 20,939 square feet of office and laboratory space at our headquarters in Gaithersburg, Maryland. Pursuant to this lease agreement, asamended, our lease will continue in effect until January 31, 2021 and may be renewed for one additional five-year period at the Company’s election. TheCompany also leases 12,770 square feet of office space at its facility in Woburn, Massachusetts under an operating lease that expires in January 2022, andprovides the Company with options to extend the lease beyond the current expiration date. Additionally, the Company leases 2,967 square feet of officespace in Denmark; this lease is currently on a month-to-month basis. Rent expenses under the Company’s facility operating leases for the years endedDecember 31, 2016 and 2015 were $1,000,726 and $683,519, respectively.We believe that our existing facilities are, or any such new facilities will be, adequate to meet our business requirements for at least the next 18 months andthat additional space will be available on commercially reasonable terms, if required.Item 3. Legal ProceedingsFrom time to time, we may be party to lawsuits in the ordinary course of business. We are currently not a party to any material legal proceedings.Item 4. Mine Safety DisclosuresNot applicable.47 PART IIItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity SecuritiesMarket InformationOur common stock and IPO warrants have traded on The NASDAQ Capital Market under the symbols “OPGN” and “OPGNW,” respectively, since May 5,2015. Prior to such time, there was no public market for our common stock or our warrants. The following table shows the high and low sales price for ourcommon stock and IPO warrants as reported by The NASDAQ Capital Market for the periods indicated: High Low Common Stock: Year Ended December 31, 2016 Fourth Quarter $1.76 $0.89 Third Quarter $3.70 $1.36 Second Quarter $1.78 $1.03 First Quarter $1.96 $1.36 IPO Warrants: Year Ended December 31, 2016 Fourth Quarter $0.26 $0.09 Third Quarter $0.49 $0.13 Second Quarter $0.46 $0.11 First Quarter $0.35 $0.19 High Low Common Stock: Year Ended December 31, 2015 Fourth Quarter $2.79 $1.45 Third Quarter $4.43 $2.21 Second Quarter (beginning May 5, 2015) $5.43 $3.12 IPO Warrants: Year Ended December 31, 2015 Fourth Quarter $0.59 $0.25 Third Quarter $0.84 $0.30 Second Quarter (beginning May 5, 2015) $0.95 $0.50 Stockholder InformationAs of March 20, 2017, there were approximately 65 stockholders of record of our common stock, which does not include stockholders that beneficially ownshares held in a “nominee” or in “street” name.DividendsWe have not paid cash dividends in the years ended December 31, 2016 and 2015. We do not anticipate paying cash dividends in the foreseeable future, aswe intend to use our revenue and capital to advance our product development and commercialization activities.Sales of Unregistered SecuritiesThe Company issued no unregistered securities during the fourth quarter of 2016.48 Use of Proceeds from the Sale of Registered SecuritiesAs of December 31, 2016, we have used all of the net cash proceeds from our IPO for sales and marketing, research and development and working capitalpurposes. There has been no material change in our planned use of the balance of the net proceeds from the IPO as described in our final prospectus datedMay 4, 2015 and filed with the SEC pursuant to Rule 424(b) under the Securities Act on May 5, 2015. We have broad discretion in the use of the netproceeds from our IPO. We may find it necessary or advisable to use the net proceeds from our IPO for other purposes than those described in our finalprospectus.Issuer Purchases of Equity SecuritiesNone.Item 6. Selected Financial DataAs a smaller reporting company, we are not required to provide the information required by this Item.Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe following Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our auditedconsolidated financial statements and the accompanying notes thereto included elsewhere in this Annual Report. This discussion contains forward-lookingstatements, based on current expectations and related to future events and our future financial performance, that involve risks and uncertainties. Our actualresults may differ materially from those anticipated in these forward-looking statements as a result of many important factors, including those set forth inthe section titled “Risk Factors” included under Part I, Item 1A of this Annual Report.OverviewOpGen was incorporated in Delaware in 2001. On July 14, 2015, OpGen completed the Merger with AdvanDx (“the Merger”) (see Note 4). Pursuant to theterms of a Merger Agreement, Velox Acquisition Corp., OpGen’s wholly owned subsidiary formed for the express purpose of effecting the Merger, mergedwith and into AdvanDx with AdvanDx surviving as OpGen’s wholly-owned subsidiary. OpGen, AdvanDx are collectively referred to hereinafter as the“Company.” The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland and Woburn,Massachusetts. The Company also has operations in Copenhagen, Denmark. The Company operates in one business segment.OpGen is a precision medicine company using molecular diagnostics and bioinformatics to help combat infectious disease. The Company is developingmolecular information products and services to combat infectious disease in global healthcare settings, helping to guide clinicians with more rapidinformation about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms.Its proprietary DNA tests and bioinformatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimizepatient care decisions and protect the hospital biome through customized screening and surveillance products and services.The Company’s molecular diagnostics and bioinformatics offerings combine its Acuitas DNA tests, Acuitas Lighthouse bioinformatics services, and CLIA labservices for MDRO surveillance. The Company is working to deliver its products and services, some in development, to a global network of customers andpartners. These include: •Its Acuitas DNA tests, which provide rapid microbial identification, and antibiotic resistance gene information. These products include theQuickFISH family of FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures, the Acuitas MDROGene Test to detect, type, track, and trend antibiotic resistant organisms in real-time and the Acuitas Rapid Test in development. The Companyis working to provide actionable, precise diagnostic information powered by pathogen surveillance data collected through hospital screeningprograms and a network of hospital and public health laboratories globally. •Its Acuitas Lighthouse bioinformatics systems, which are cloud-based HIPAA compliant bioinformatics offerings that combine clinical lab testresults with patient and hospital information and provide analytics to help manage MDROs in the hospital and patient care environment. Theseinclude its Acuitas Lighthouse informatics, which can be specific to a healthcare facility, public health department or collaborator, such as apharmaceutical company, and its Acuitas Lighthouse Knowledgebase, a proprietary data warehouse in development to include genomic datamatched with antibiotic susceptibility information for microbes and patient information from healthcare providers, in which the Company isbeginning to collect and store MDRO information from a variety of sources for use with its Acuitas Rapid Test in development. 49 The Company’s operations are subject to certain risks and uncertainties. The risks include rapid technology changes, the need to manage growth, the need toretain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. TheCompany’s success depends, in part, on its ability to develop and commercialize its proprietary technology as well as raise additional capital.Recent DevelopmentsSince inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarilythrough external investor financing arrangements. The Company raised significant funds in 2016, including: •$9.5 million in net proceeds from the issuances of common stock, non-voting convertible preferred stock and stock purchase warrants in aprivate placement to members of management and to accredited investors, including Merck GHI and jVen Capital. •$4.4 million in net proceeds under the "at the market offering" program from the selling of approximately 3.6 million shares of its commonstock.See “Liquidity and Capital Resources” below for a description of the Company’s recent financing activities.Results of Operations for the Years Ended December 31, 2016 and 2015Revenues Year Ended December 31, 2016 2015 Revenue Product sales $3,524,178 $2,701,142 Laboratory services 228,904 120,476 Collaboration revenue 272,603 336,102 Total revenue $4,025,685 $3,157,720 Our total revenue for the year ended December 31, 2016 increased 27%, to $4.0 million from $3.2 million, when compared to the same period in 2015. Thisincrease is primarily attributable to: •Product Sales: the increase in revenue of 30% in 2016 as compared to 2015 is attributable to the inclusion of AdvanDx products salessubsequent to the Merger, offset in part by a reduction in the sale of our Argus products, as we transition from our legacy mapping products tothe introduction of Acuitas MDRO products; •Laboratory Services: the increase in revenue of 90% in 2016 as compared to 2015 is a result of increases in sales of our Acuitas MDRO testservices and Acuitas Lighthouse services; and •Collaboration Revenue: the decrease in collaboration revenue of 19% in 2016 as compared to 2015 is primarily the result of decreased revenueassociated with our technology development agreement with Hitachi, partially offset by $135,000 of revenue recognized related to theCompany’s agreement with Healthcare Services & Solutions LLC, an affiliate of Merck GHI.Operating expenses Year Ended December 31, 2016 2015 Cost of products sold $1,658,571 $1,179,771 Cost of services 631,333 367,802 Research and development 8,613,236 6,002,941 General and administrative 6,602,608 5,834,642 Sales and marketing 5,529,274 4,305,444 Transaction expenses — 526,283 Total operating expenses $23,035,022 $18,216,883 50 The Company’s total operating expenses for the year ended December 31, 2016 increased 26%, to $23.0 million from $18.2 million, when compared to thesame period in 2015. This increase is primarily attributable to: •Costs of products sold: cost of products sales for the year ended December 31, 2016 increased approximately 41% when compared to the sameperiod in 2015. The change in costs of products sold is primarily attributable to the inclusion of AdvanDx costs of products sold subsequent tothe Merger, offset in part by a reduction in the costs of products sold of our Argus products, as we transition from our legacy mapping productsto the introduction of Acuitas MDRO products; •Costs of services: cost of services for the year ended December 31, 2016 increased approximately 72% when compared to the same period in2015. The change in costs of services is primarily attributable to an increase in sales of our Acuitas MDRO test services and Acuitas Lighthouseservices; •Research and development: research and development expenses for the year ended December 31, 2016 increased approximately 43% whencompared to the same period in 2015, primarily due to costs related to the Automated Pathogen identification project; •General and administrative: general and administrative expenses for the year ended December 31, 2016 increased approximately 13% whencompared to the same period in 2015, primarily due to a full-year of payroll and facility costs associated with the AdvanDx acquisition in 2015and public company costs; •Sales and marketing: sales and marketing expenses for the year ended December 31, 2016 increased approximately 28% when compared to thesame period in 2015, primarily due to costs associated with our expanded sales and marketing team, the Intermountain HealthcareRetrospective study, and industry trade show expenses; and •Transaction expenses: transaction expenses for the year ended December 31, 2016 decreased 100% when compared to the same period in 2015due to the prior year acquisition of AdvanDx Inc.Other income (expense) Year Ended December 31, 2016 2015 Interest expense $(143,347) $(1,801,320)Foreign currency transaction losses (8,102) — Change in fair value of derivative financial instruments — (647,342)Interest and other (expense)/income (5,967) 26,657 Total other expense $(157,416) $(2,422,005) Other expense for the year ended December 31, 2016 decreased to a net expense of $157,416 from a net expense of $2,422,005 in the same period of 2015,and was primarily the result of a reduction in interest expense due to the settlement of a significant portion of our debt upon the closing of our IPO and thereclassification of derivative warrant liabilities, which were reclassified to stockholders’ equity upon the closing of our IPO when their net cash-settlementfeatures lapsed.The Company recognized a benefit for income taxes of $0.1 million for the year ended December 31, 2015 (none in 2016) as a result of the net deferred taxliabilities in a U.S. taxing jurisdiction related to the AdvanDx Merger.Liquidity and capital resourcesAt December 31, 2016, the Company had cash and cash equivalents of $4.1 million, compared to $7.8 million at December 31, 2015. The Company hasfunded its operations primarily through external investor financing arrangements and has raised significant funds in 2016 and 2015, including:On September 13, 2016, the Company entered into the Sales Agreement with Cowen and Company LLC (“Cowen”) pursuant to which the Company mayoffer and sell from time to time, up to an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to anaggregate of $11.5 million. Pursuant to the Sales Agreement, Cowen may sell the shares of common stock by any method permitted by law deemed to be an"at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made bymeans of ordinary brokers' transactions on The NASDAQ Capital Market or otherwise at market prices prevailing at the time of sale, in block transactions, oras otherwise directed by the Company. The Company pays Cowen compensation equal to 3.0% of the gross proceeds from the sales of common stockpursuant to the terms of the Sales Agreement. As of December 31, 2016, the Company has sold an aggregate of approximately 3.6 million shares of itscommon stock under this at the market offering resulting in aggregate net proceeds to the51 Company of approximately $4.4 million, and gross proceeds of $4.7 million. As of December 31, 2016, remaining availability under the at the marketoffering is $6.8 million. Subsequent to December 31, 2016, the Company has sold an aggregate of approximately 2.1 million shares of its common stockunder this at the market offering resulting in aggregate net proceeds to the Company of approximately $2.1 million, and gross proceeds of $2.2 million.Under the initial sales agreement, remaining availability under the at the market offering is $4.6 million.In May and June 2016, the Company offered and sold units in a private offering to members of management and employees and to accredited investors,including Merck GHI and jVen Capital, each unit consisting of either (i) one share of common stock and a detachable stock purchase warrant to purchase anadditional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase anadditional 0.75 shares of common stock, at a price of $1.14 per unit. The total net proceeds to the Company, after deducting offering commissions andexpenses was $9.5 million. The Company intends to use the proceeds for working capital and general corporate purposes. Pursuant to the private placement,the Company issued 6,744,127 shares of common stock, 2,309,428 of non-voting convertible preferred stock and stock purchase warrants to acquire anadditional 6,790,169 shares of common stock.In July 2015, the Company raised $6.0 million by issuing 1,136,364 shares of common stock at $4.40 per share and a $1.0 million senior secured promissorynote to Merck GHI. Also in July 2015, the Company entered into a Registration Rights Agreement with Merck GHI and the AdvanDx stockholders whoreceived Merger Consideration in the Merger, which will require the Company to register such shares of Company common stock for resale by such holdersin the future. Under the Purchase Agreement, Merck GHI has the right to participate in future securities offerings made by the Company.In May 2015, OpGen completed its IPO pursuant to which it offered and sold 2,850,000 units, each unit consisting of one share of common stock and adetachable stock purchase warrant to purchase an additional share of common stock, at an initial offering price of $6.00 per unit. Of the total gross proceedsof $17.1 million, approximately $2.1 million was used to satisfy outstanding demand notes by exchanging such notes for 350,000 units in the IPO. Afterconsidering the demand notes, underwriting discounts and commissions and offering expenses, the total net cash proceeds were $12.1 million. On the IPOclosing date, the underwriters exercised their over-allotment option to acquire an additional 422,500 stock purchase warrants. In connection with the IPO, allof OpGen’s outstanding Series A redeemable convertible preferred stock, 2014 convertible notes and 2015 convertible notes were converted into 7,374,852shares of common stock.To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional equity financings, debt financings andother funding transactions, licensing and/or partnering arrangements and business combination transactions. There can be no assurance that the Companywill be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash on hand will be sufficient to fundoperations into the second quarter of 2017. In the event the Company is unable to successfully raise additional capital during or before the second quarter of2017, the Company will not have sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in suchcircumstances the Company would be compelled to immediately reduce general and administrative expenses and delay research and development projects,including the purchase of scientific equipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received timely,the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcyprotection.Sources and uses of cashThe following table summarizes the net cash and cash equivalents provided by (used in) operating activities, investing activities and financing activities forthe periods indicated: Year Ended December 31, 2016 2015 Net cash used in operating activities $(17,250,637) $(14,278,004)Net cash (used in)/provided by investing activities (123,514) 1,181,915 Net cash provided by financing activities 13,664,690 20,169,078 Net cash used in operating activitiesNet cash used in operating activities in 2016 consists primarily of our net loss of $19.2 million, reduced by certain non-cash items, including depreciationand amortization expense of $0.7 million, share-based compensation of $0.9 million, and the net change in operating assets and liabilities of $0.2 million.Net cash used in operating activities for 2015 consists primarily of our net loss of $17.4 million, reduced by certain non-cash items, including depreciationand amortization expense of $0.6 million, share-based compensation expense of $1.4 million, partially offset by the net change in operating assets andliabilities of $1.1 million.52 Net cash used in/provided by investing activitiesNet cash used in/provided by investing activities in 2016 consisted solely of the purchase of property and equipment. Net cash provided by investingactivities in 2015 includes cash on hand at AdvanDx at the date of the Merger of $1.4 million, along with the purchase of property and equipment.Net cash provided by financing activitiesNet cash provided by financing activities in 2016 of $13.7 million consisted primarily of the net proceeds from our private placement of common stock, non-voting convertible preferred stock and stock purchase warrants and issuance of common stock under the ATM offering. Net cash provided by financingactivities in 2015 of $20.2 million consisted primarily of the net proceeds from our IPO of $12.1 million, the net proceeds from the issuance of common stockto Merck GHI of $5.0 million, and the net proceeds from the issuance of debt instruments (including a $1.0 million senior secured promissory note to MerckGHI) of $3.1 million.Critical accounting policies and use of estimatesThis Management's Discussion and Analysis of Financial Condition and Results of Operations is based on our audited consolidated financial statements,which have been prepared in accordance with GAAP. The preparation of financial statements in conformity with GAAP requires us to make estimates andassumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statementsand the reported amount of revenues and expenses during the reporting period. In our audited consolidated financial statements, estimates are used for, butnot limited to, share-based compensation, allowances for doubtful accounts and inventories, valuation of derivative financial instruments, beneficialconversion features of convertible debt, deferred tax assets and liabilities and related valuation allowance, and depreciation and amortization and estimateduseful lives of long-lived assets. Actual results could differ from those estimates.A summary of our significant accounting policies is included in Note 3 to the accompanying audited consolidated financial statements. Certain of ouraccounting policies are considered critical, as these policies require significant, difficult or complex judgments by management, often requiring the use ofestimates about the effects of matters that are inherently uncertain.Revenue RecognitionRevenue for the sales of QuickFISH, PNA FISH and XpressFISH diagnostic test products is recognized upon shipment to the customer.The Company recognizes revenue associated with laboratory services contracts when the service has been performed and reports are made available to thecustomer.The Company recognizes revenue primarily from sales of the Argus System, sales of extended warranty service contracts for the Argus System, sales ofAdvanDx diagnostic products, providing laboratory services, and from “funded software development” arrangements with collaborative parties. Revenue isrecognized when the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred; the selling price is fixed ordeterminable; and collectability is reasonably assured. At times, the Company sells products and services, or performs software development, under multiple-element arrangements with separate units of accounting; in these situations, total consideration is allocated to the identified units of accounting based ontheir relative fair value and revenue is then recognized for each unit based on its specific characteristics.When an Argus System is sold without the Genome Builder software, total arrangement consideration is recognized as revenue when the system is deliveredto the customer. Ancillary performance obligations, including installation, limited customer training and limited consumables, are consideredinconsequential and are combined with the Argus System as one unit of accounting. When an Argus System is sold with the Genome Builder software in amultiple-element arrangement, total arrangement consideration is allocated to the Argus System and to the Genome Builder software (considered multipleelements) based on their relative selling prices. Selling prices are determined based on sales of similar systems to similar customers and, where no sales haveoccurred, on management’s best estimate of the expected selling price relative to similar products. Revenue related to the Argus System is recognized when itis delivered to the customer; revenue for the Genome Builder software is recognized when it is delivered to the customer. Revenue is recognized for GenomeBuilder software and for consumables, when sold on a stand-alone basis, upon delivery to the customer.The Company recognizes revenue associated with extended warranty service contracts over the service period in proportion to the costs expected to beincurred over that same period. The Company’s funded software development arrangements generally consist of multiple elements. Total arrangementconsideration is allocated to the identified units of accounting based on their relative selling53 prices and revenue is then recognized for each unit based on its specific characteristics. When funded software development arrangements includesubstantive research and development milestones, revenue is recognized for each such milestone when the milestone is achieved and is due and collectible.Milestones are considered substantive if all of the following conditions are met: (1) the milestone is nonrefundable; (2) achievement of the milestone was notreasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of the milestoneappears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with achievement of themilestone.Impairment of Long-Lived AssetsProperty and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not berecoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cashflows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level forwhich we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assetsexceeds the fair value of the assets.Definite-lived intangible assets include trademarks, developed technology and customer relationships. If any indicators were present, the Company wouldtest for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those netundiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is todetermine the fair value of the asset and record an impairment loss, if any.Goodwill represents the excess of the purchase price for AdvanDx over the fair values of the acquired tangible or intangible assets and assumed liabilities.The Company will conduct an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur orcircumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value.Share-Based CompensationShare-based payments to employees, directors and consultants are recognized at fair value. The resulting fair value is recognized ratably over the requisiteservice period, which is generally the vesting period of the option. The estimated fair value of equity instruments issued to nonemployees is recorded at fairvalue on the earlier of the performance commitment date or the date the services required are completed.For all time-vesting awards granted, expense is amortized using the straight-line attribution method. For awards that contain a performance condition,expense is amortized using the accelerated attribution method. Share-based compensation expense recognized is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. The fair value of share-based payments is estimated, on the date of grant, using the Black-Scholes model. Option valuation models, including the Black-Scholes model, require the input of highly subjective estimates and assumptions, and changesin those estimates and assumptions can materially affect the grant-date fair value of an award. These assumptions include the fair value of the underlying andthe expected life of the award.See additional discussion of the use of estimates relating to share-based compensation, and a discussion of management’s methodology for developing eachof the assumptions used in such estimates, in Note 3 to the accompanying consolidated financial statements.Recent accounting pronouncementsIn May 2014, the Financial Accounting Standards Board (“FASB”) issued guidance for revenue recognition for contracts, superseding the previous revenuerecognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identifythe contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The newstandard will result in enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenue arising from contracts with customers. In August2015, the FASB issued guidance approving a one-year deferral, making the standard effective for reporting periods beginning after December 15, 2017, withearly adoption permitted only for reporting periods beginning after December 15, 2016. In March 2016, the FASB issued guidance to clarify theimplementation guidance on principal versus agent considerations for reporting revenue gross rather than net, with the same deferred effective date. In April2016, the FASB issued guidance to clarify the identification of performance obligations and licensing arrangements. In May 2016, the FASB issued guidanceaddressing the presentation of sales and other similar taxes collected from customers, providing clarification of the collectability criterion assessment, as wellas clarifying certain transition requirements. The Company is currently evaluating the impact, if any, that this guidance will have on its consolidatedfinancial statements.54 In August 2014, the FASB issued guidance requiring management to evaluate on a regular basis whether any conditions or events have arisen that could raisesubstantial doubt about the entity’s ability to continue as a going concern. The guidance 1) provides a definition for the term “substantial doubt,” 2) requiresan evaluation every reporting period, interim periods included, 3) provides principles for considering the mitigating effect of management’s plans to alleviatethe substantial doubt, 4) requires certain disclosures if the substantial doubt is alleviated as a result of management’s plans, 5) requires an express statement,as well as other disclosures, if the substantial doubt is not alleviated, and 6) requires an assessment period of one year from the date the financial statementsare issued. This guidance is effective for the annual periods ending after December 15, 2016 and for annual and interim reporting periods thereafter. TheCompany has made the appropriate disclosures required by this guidance. The adoption of this guidance has had no financial statement impact.In April 2015, the FASB issued accounting guidance requiring that debt issuance costs related to a recognized liability be presented on the balance sheet as adirect reduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuancecosts are not affected. The standard is effective for reporting periods beginning after December 15, 2015. The Company adopted this guidance effectiveJanuary 1, 2016 on a retrospective basis, and all periods are presented under this guidance.In April 2015, the FASB issued guidance as to whether a cloud computing arrangement (e.g., software as a service, platform as a service, infrastructure as aservice, and other similar hosting arrangements) includes a software license and, based on that determination, how to account for such arrangements. If acloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistentwith the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for thearrangement as a service contract. The guidance is effective for reporting periods beginning after December 15, 2015, and can be adopted on either aprospective or retrospective basis. The Company adopted this guidance for the year ended December 31, 2016, on a prospective basis. The adoption of thisnew guidance did not have a material impact on the Company’s consolidated financial statements.In July 2015, the FASB issued accounting guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidanceat the lower of cost and net realizable value, except when inventory is measured using LIFO or the retail inventory method. Net realizable value is theestimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASBhas amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The standardis effective for reporting periods beginning after December 15, 2016. The amendments in this pronouncement should be applied prospectively, with earlierapplication permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidatedfinancial statements.In February 2016, the FASB issued guidance for the accounting for leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the consolidated balance sheets and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reportingperiods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides forcertain practical expedients. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its financialstatements.In March 2016, the FASB issued guidance simplifying the accounting for and financial statement disclosure of stock-based compensation awards. Under theguidance, all excess tax benefits and tax deficiencies related to stock-based compensation awards are to be recognized as income tax expenses or benefits inthe income statement and excess tax benefits should be classified along with other income tax cash flows in the operating activities section of the statementof cash flows. Under the guidance, companies can also elect to either estimate the number of awards that are expected to vest or account for forfeitures as theyoccur. In addition, the guidance amends some of the other stock-based compensation awards guidance to more clearly articulate the requirements and cashflow presentation for withholding shares for tax-withholding purposes. The guidance is effective for reporting periods beginning after December 15, 2016and early adoption is permitted, though all amendments of the guidance must be adopted in the same period. The adoption of certain amendments of theguidance must be applied prospectively, and adoption of the remaining amendments must be applied either on a modified retrospective basis orretrospectively to all periods presented. The Company elected to adopt the guidance effective for the fiscal year ended December 31, 2016 and apply itretrospectively for all periods presented. This has not materially impacted the Company's consolidated results of operations, financial position or cash flows.The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have amaterial impact on its consolidated results of operations, financial position, or cash flows.Off-Balance Sheet ArrangementsAs of December 31, 2016 and 2015, the Company did not have any off-balance sheet arrangements.55 JOBS ActOn April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extendedtransition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an “emerginggrowth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The Companyhas elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. Thiselection allows it to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until thosestandards apply to private companies. As a result of this election, the Company’s financial statements may not be comparable to companies that comply withpublic company effective dates.Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” the Company intends to rely on certain of these exemptions,including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section404(b) of the Sarbanes-Oxley Act of 2002 and (ii) complying with any requirement that may be adopted by the PCAOB regarding mandatory audit firmrotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditordiscussion and analysis. The Company will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which it has totalannual gross revenues of $1 billion or more; (ii) December 31, 2019; (iii) the date on which the Company has issued more than $1 billion in nonconvertibledebt during the previous three years; or (iv) the date on which the Company is deemed to be a large accelerated filer under the rules of the SEC.Item 7A. Quantitative and Qualitative Disclosures About Market RiskAs a smaller reporting company, the Company is not required to provide the information required by this Item.Item 8. Financial StatementsThe Company’s consolidated financial statements and the report of our independent registered public accounting firm are included in this Annual Report asindicated in Part IV, Item 15.Item 9. Changes in and Disagreements with Accountants on Accounting and Financial DisclosureNone.Item 9A. Controls and ProceduresEvaluation of Disclosure Controls and ProceduresThe Company's management evaluated, with the participation of the Company's principal executive and principal financial officers, the effectiveness of theCompany's disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of December 31, 2016. We maintaindisclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the ExchangeAct is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulatedand communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisionsregarding disclosure. Based on their evaluation, management has concluded that the Company's disclosure controls and procedures were effective as ofDecember 31, 2016.Changes in Internal Control over Financial ReportingIn the fourth quarter ended December 31, 2016, there have been no changes in the Company's internal controls over financial reporting that have materiallyaffected, or are reasonably likely to materially affect, the Company's internal controls over financial reporting.Management’s Annual Report on Internal Control over Financial ReportingThe Company's management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f)and 15d-15(f) under the Exchange Act). The Company's internal control system was designed to provide reasonable assurance regarding the preparation andfair presentation of published financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detectmisstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because ofchanges in conditions, or that the56 degree of compliance with the policies or procedures may deteriorate. Under the supervision and with the participation of management, including theCompany's Chief Executive Officer and Chief Financial Officer, the Company assessed the effectiveness of internal control over financial reporting as ofDecember 31, 2016. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the TreadwayCommission ("COSO") in its statement "Internal Control-Integrated Framework (2013)."Based on this assessment, management has concluded that, as of December 31, 2016, internal control over financial reporting is effective based on thesecriteria.Item 9B. Other InformationNone.57 PART IIIItem 10. Directors and Executive Officers and Corporate GovernanceThe Board of Directors of the Company (the “Board”) are elected at the annual meeting of the stockholders, and serve for the term for which each director iselected and until his or her successor is elected and qualified. Executive officers of the Company are elected by the Board, and serve for a term of one yearand until their successors have been elected and qualified or until their earlier resignation or removal by the Board. There are no family relationships amongany of the directors and executive officers of the Company. None of the executive officers or directors has been involved in any legal proceedings of the typerequiring disclosure by the Company during the past ten years. On July 14, 2015, the Company entered into a Common Stock and Note Purchase Agreement(the “Purchase Agreement”) with Merck GHI. Pursuant to the Purchase Agreement, the Company’s Board was expanded to seven (7) members and Merck GHIhad the right, subject to the consent of the Company, to fill the new vacancy on the Board. Additionally, for as long as Merck GHI holds at least five percent(5%) of the outstanding common stock of the Company, the Board is required to nominate Merck GHI’s designee, or any replacement, for election by thestockholders at each annual or special meeting of the stockholders at which directors are elected. Merck GHI nominated, and the Board consented to, DavidM. Rubin Ph.D. serving as its designee on the Board. Otherwise, there are no arrangements or understandings between any director or executive officer andthe Company pursuant to which he or she was selected as a director. The following table sets forth the names and ages of all directors, director nominees and executive officers of the Company and their respective positionswith the Company as of the date of this Annual Report: Name Age PositionDirectors Evan Jones 60 Chief Executive Officer, Director and Chairman of the BoardBrian G. Atwood 64 DirectorHarry J. D'Andrea 60 DirectorTimothy J.R. Harris, Ph.D., D.Sc 66 DirectorLaurence R. McCarthy, Ph.D. 72 DirectorDavid M. Rubin, Ph.D. 52 DirectorMisti Ushio, Ph.D. 45 Director Other Executive Officers Timothy C. Dec 58 Chief Financial Officer and Corporate SecretaryGeoffrey McKinley 65 Senior Vice President of R&D and Business DevelopmentVadim Sapiro 46 Chief Information OfficerRobert McG. Lilley 71 Chief Commercial OfficerG. Terrance Walker 58 Senior Vice President, Research and Development Board of Directors The following information summarizes, for each of our directors, his or her principal occupations and other public company directorships for at least the lastfive years and information regarding the specific experiences, qualifications, attributes and skills of such director:Evan Jones. Mr. Jones has served as our Chief Executive Officer since October 2013 and as Chairman of our Board since September 2010. He served as ourPresident from October 2013 until April 2015. Since 2007, Mr. Jones has served as managing member of jVen Capital, LLC, a life sciences investmentcompany. Previously, he co-founded Digene Corporation, a publicly traded biotechnology company focused on women’s health and molecular diagnostictesting that was sold to Qiagen N.V. (NASDAQ: QGEN) in 2007. He served as chairman of Digene’s board of directors from 1995 to 2007, as Digene’s chiefexecutive officer from 1990 to 2006, and as Digene’s president from 1990 to 1999. Mr. Jones currently serves on the board of directors of FluidigmCorporation (NASDAQ: FLDM), a technology company that develops, manufactures and markets life science analytical and preparatory systems, sinceMarch 2011, Foundation Medicine, Inc. (NASDAQ: FMI), a cancer testing molecular informatics company, since January 2013, and Veracyte, Inc. (NASDAQ:VCYT), a leading genomic diagnostics company, since 2008. Mr. Jones received a B.A. from the University of Colorado and an M.B.A. from The WhartonSchool at the University of Pennsylvania. We believe that Mr. Jones’ qualifications to serve as CEO of the Company and as Chairman of our Board includehis extensive experience in the molecular diagnostic testing industry, including as chief executive officer of a public company focused on moleculardiagnostic testing, as well as his service as a board member with other public and private companies and Vice Chair of the board at Children’s NationalMedical Center in Washington, D.C. The Board believes that Mr. Jones’ more than 30 years’ leadership experience in the58 life science and healthcare industries, his extensive board experience at privately held, publicly traded companies and nonprofit healthcare institutions, andhis investment expertise, coupled with his deep understanding of our technologies, product candidates, market and history make him an essential contributorto our Board, including his service as Chairman of the Board.Brian G. Atwood. Mr. Atwood has been a director of OpGen since July 2007 and is currently a member of our Audit Committee. Mr. Atwood co-foundedCell Design Labs, Inc., a privately held company focused on developing human cell engineering technology, and has served as its President and ChiefExecutive Officer since July 2015. Mr. Atwood is also a Managing Director and was a co-founder of Versant Ventures. He also has more than fifteen years ofoperating experience in the biotechnology industry, with emphasis on therapeutic products, devices, diagnostics, and research instrumentation. Prior tolaunching his career in venture capital, Mr. Atwood was founder, President, and CEO of Glycomed Incorporated, a publicly traded biotechnologycompany. Prior to Glycomed, he co-founded and served as director of Perkin Elmer/Cetus Instruments, a joint venture for robotics automation and genomicsresearch instruments and products later acquired by Perkin Elmer. He currently serves as a board member at the private company Atreca, Inc., as well as thepublic companies, PhaseRX, Inc. (NASDAQ: PZRX) and Clovis Oncology, Inc. (NASDAQ: CLVS). Mr. Atwood received a B.S. in Biological Sciences fromthe University of California, Irvine; an M.S. from the University of California, Davis, and an M.B.A. from Harvard Business School. Mr. Atwood’s extensivebiotechnology, bioinformatics and investing experience, and his familiarity with both publicly traded and privately held companies in our industry, positionhim to provide valuable insight and make substantial contributions to our Board and Audit Committee.Harry J. D’Andrea. Mr. D’Andrea has been a director of OpGen since April 2016. Mr. D’Andrea is managing general partner of Valhalla Partners, a venturecapital firm, a position he has held since January 2012. He previously served as administrative general partner of Valhalla Partners since June 2002, and wasa co-founder of Valhalla Partners in 2002. From June 1999 to February 2002, Mr. D’Andrea was Chief Financial Officer of Advanced SwitchingCommunications, Inc., a Nasdaq-listed company that completed its IPO in October 2000. Prior thereto from 1989 to 1999 he held senior financial positionswith a number of privately held and public companies. Mr. D’Andrea has served on the boards of two publicly traded companies in the past. He received hisB.A. in Foreign Service from The Pennsylvania State University in 1978 and his MBA from Drexel University in 1980. The Board believes that Mr.D’Andrea’s qualifications, attributes and skills for service on our Board and Audit Committee include his experience as a managing general partner of aventure fund, his board experience, his extensive experience in senior financial positions, including serving as a chief financial officer of three publiclytraded companies, and his qualification as a financial expert. Timothy J.R. Harris, Ph.D., D.Sc. Dr. Harris has been a director of OpGen since April 2015. Dr. Harris is a molecular biologist and biochemist and anexecutive with over thirty-two years of experience. Dr. Harris is currently acting Head of Research and Development for Bioverativ Inc. (NASDAQ:BIVV). He is also a venture partner of SV Life Sciences, a position he has held since March 2016. He previously served as the Senior Vice President forPrecision Medicine at Biogen, Inc. (NASDAQ: BIIB) from March 2015 until February 2016. Prior to such position, he was Senior Vice President forTranslational Medicine and Technology at Biogen from June 2011 to February 2015. Before joining Biogen, he was the Chief Technology Officer andDirector of the Advanced Technology Program at SAIC-Frederick, Inc. in Maryland from January 2007 to June 2011. His professional experience includessenior executive positions at a number of companies, including Novasite Pharmaceuticals, where he has served as President and Chief Executive Officer fromJanuary 2005 to September 2006. Dr. Harris founded SGX Pharmaceuticals, Inc. (formerly Structural GenomiX Inc.) (SGX) in 1999. Before founding SGX, Dr.Harris was Senior Vice President, Research and Development at Axys Pharmaceuticals Inc. (formerly Sequana Therapeutics Inc.). Dr. Harris received a Ph.D.and M.S. in General Virology and a B.Sc. in Biochemistry from the University of Birmingham in England and has an honorary doctorate (D.Sc.) from theUniversity of Birmingham, UK awarded in July 2010. Dr. Harris serves on the board of directors of BG Medicine, Inc. Dr. Harris brings the followingqualifications and skills to his service on the Board—his extensive executive officer experience at publicly held and privately owned pharmaceutical andbiotechnology companies, and his scientific experience, coupled with his familiarity with, and contributions to, OpGen from his service on the Clinical andScientific Advisory Board from May 2011 to May 2015.Laurence R. McCarthy, Ph.D. Dr. McCarthy has been a director of OpGen since July 2013. Dr. McCarthy joined Ampersand Capital Partners in 2007 as anOperating Partner and serves as a Director of Dynex Technologies, Inc. He has served as Executive Chairman of Bako Pathology Services, ExecutiveChairman of Viracor-IBT, Executive Chairman of PrimeraDx, and as a member of the board of directors of Magellan Diagnostics, Inc. and Genoptix, Inc.(GXDX), and as the President and CEO, through 2004, and later as Chairman and Chief Technology Officer, of Focus Diagnostics, Inc. until its acquisition byQuest Diagnostics Incorporated in 2006. Prior to Focus Diagnostics, Dr. McCarthy served in various positions at Boehringer Mannheim GmbH and BectonDickinson & Co. He holds a Ph.D. in Microbiology from the University of New Hampshire and served on the faculties of Johns Hopkins, the University ofNorth Carolina and Cornell University. Dr. McCarthy’s greater than 40 years’ experience in healthcare, his background in building and growing companiesin biotechnology, microbiology, laboratory services and healthcare industries, his technical expertise in infectious disease, as well as his senior managementexperience, faculty positions and board service at diagnostic and infectious disease-focused companies and academic institutions allow him to play anintegral role as a member of our Board, Compensation Committee and Compliance Committee, of which he is the Chair. His experience in manybiotechnology and life science companies59 gives him an understanding and appreciation of the many regulatory and developmental issues confronting diagnostic laboratory and biotechnologycompanies. He also served on our Scientific and Clinical Advisory Board from July 2013 until May 2015. David M. Rubin, Ph.D. Dr. Rubin is currently a managing director at Merck GHI, where he is responsible for identifying investment opportunities inemerging health care solutions and services, with a particular emphasis on solutions for personalized medicine and point of care diagnostics. Prior to joiningMerck GHI, Dr. Rubin managed Merck & Co.’s efforts in MRL Oncology. Dr. Rubin joined Merck in 2007 from Cognia Corporation, where he was thepresident and chief executive officer. Previously, Dr. Rubin was at The Wilkerson Group/IBM Global Services. In addition, Dr. Rubin previously founded andran a venture-backed research and development software and content products company. Dr. Rubin previously served on the board of VirtualScopics, Inc.(NASDAQ: VSCP) from 2012 through 2014. Dr. Rubin currently serves on the boards of directors of Daktari Diagnostics, Inc., Electrocore Medical, LLC,Navigating Cancer, Inc. and Prophecy Inc. Dr. Rubin was a National Institute of Health and American Cancer Society post-doctoral fellow at HarvardMedical School. Dr. Rubin also received training in post‑graduate business at Harvard University. Dr. Rubin holds a Ph.D. from Temple University inMolecular Biology and a B.A. from SUNY Binghamton in Biology. Dr. Rubin’s extensive background working with precision medicine and diagnosticcompanies, his investing experience, his current executive position with Merck GHI and scientific background make Dr. Rubin a valuable contributor to theBoard and the Audit Committee of the Board.Misti Ushio, Ph.D. Dr. Ushio has been a director of OpGen since March 2012. Dr. Ushio is the co-founding chief executive officer and a director of TARABiosystems, a position she has held since February 2016. Prior thereto, she was Chief Strategy Officer and a Managing Director at Harris & Harris Group, Inc.from May 2007 to February 2016. Prior to joining Harris & Harris, Dr. Ushio worked at Merck & Co. (NYSE: MRK) for over ten years in bioprocess research& development, and was a Technology Licensing Officer at Columbia University. Dr. Ushio currently serves or has served on the boards of Accelerator-NYC,AgBiome, Enumeral Biomedical, Lodo Therapeutics, Petra Pharma, Senova Systems and SynGlyco. Dr. Ushio holds a B.S. in Chemical Engineering fromJohns Hopkins University, an M.S. in Chemical Engineering from Lehigh University, and a Ph.D. in Biochemical Engineering from University CollegeLondon. Dr. Ushio’s board, management and operational leadership experience, her familiarity with both private and publicly traded companies in ourindustry and her scientific background make Dr. Ushio a valuable contributor to our Board and to our Compensation Committee, of which she is Chair.Executive OfficersThe following information summarizes, for each of our officers, his principal occupations and other employment for at least the last five years:Evan Jones. See above under “Board of Directors.”Timothy C. Dec. Mr. Dec joined OpGen as our interim Chief Financial Officer in April 2015 and became our Chief Financial Officer in May 2015. Prior tojoining OpGen, Mr. Dec served as Senior Vice President and Chief Financial Officer for Clubwidesports, LLC, a start-up sports management softwarecompany, from January 2014 to April 2015. From December 2012 to the present, Mr. Dec is an adjunct professor at Mount St. Mary’s University, where heteaches M.B.A. courses in Finance. From August 2007 to December 2012, Mr. Dec served as Senior Vice President and Chief Financial Officer of FortressInternational Group, Inc., a publicly traded company. Mr. Dec has served in chief financial officer or other senior financial executive roles at companies in anumber of industries from September 1986 through August 2007, including three publicly traded companies listed on NASDAQ or AMEX, such as CorvisCorporation, and with private equity-backed companies. Mr. Dec also has public accounting firm experience. Mr. Dec received his B.S. in Accounting fromMount St. Mary’s University and an M.B.A. from American University.Geoffrey A. McKinley, Ph.D. Dr. McKinley joined OpGen as Senior Vice President of R&D and Business Development in July 2015 when OpGen acquiredAdvanDx, Inc. At AdvanDx, Dr. McKinley was Senior Vice President of R&D and Business Development responsible for R&D strategy and new productdevelopment plan from November 2014 until July 2015. Prior to AdvanDx, Dr. McKinley was Chief Science Officer at DxNA, Inc. from December 2013 toOctober 2014. Prior to DxNA, Dr. McKinley was Senior Vice President of Research & Development at GenturaDx, Inc. from June 2011 to July 2013. Dr.McKinley was employed by Osmetech plc (LSE:OMH) (currently GenMark Diagnostics, Inc. NASDAQ:GNMK) from 2004 to June 2011 and served as itsVice President of Molecular Diagnostics Research & Development and Business Development. From 1994 to 2004, Dr. McKinley served in senior R&D andbusiness development positions with life sciences companies. Dr. McKinley is an author on 12 U.S. patents. He received his B.S. from Grove City College in1973 and received his Ph.D. from Colorado State University in 1979.Vadim Sapiro. Mr. Sapiro joined OpGen in December 2011 as Chief Information Officer. Mr. Sapiro is responsible for leading the development of theCompany’s bioinformatics applications, software, databases and information technology operations. Prior to joining OpGen, Mr. Sapiro was Senior VicePresident at SAIC-Frederick (now Leidos Biomedical Research Inc.) from June 2008 to December 2011, overseeing the Information Systems Program for theNational Cancer Institute at SAIC-Frederick. From January60 2007 to May 2008, Mr. Sapiro served as Vice President for Information Technology of J. Craig Venter Institute, a non-profit research institute. Mr. Sapiroserved in other senior information technology roles from July 1999 through December 2006, including another non-profit research institute. Mr. Sapiro holdsa B.S. in Mathematics and Computer Science from the University of Maryland.Robert McG. Lilley. Mr. Lilley joined OpGen in October 2014 as Chief Commercial Officer. Mr. Lilley is currently non‑executive Chairman of the Board ofDirectors of Immunexpress, Inc., a Seattle-based molecular diagnostic company focused on developing diagnostic tests for patients at risk of sepsis. Hepreviously served as Senior Vice President, Global Sales and Marketing for Digene Corporation, from June 1999 until its sale to QIAGEN NV in 2007. He hadheld prior sales executive positions with Digene from March 1997 to June 1999. Mr. Lilley worked for QIAGEN NV as Senior Advisor, MolecularDiagnostics from August 2007 until September 2009. He previously served as Head of Europe, Middle East, and Africa (EMEA) Sales and Marketing for TDSHealthcare Information Systems, as well as Senior Vice President and General Manager EMEA of Alltel Healthcare Systems. In 1970, Mr. Lilley joined thefirst Earth Day team, and he has retained an interest in environmental affairs since. Today he serves on the Boards of the Global Footprint Network, and TerraGlobal Capital, both based in the San Francisco Bay Area. He has also served on the Board of Trustees of The Center for Advanced Studies in the BehavioralSciences at Stanford University. Mr. Lilley holds a BA from Yale University.G. Terrance Walker, Ph.D. Dr. Walker joined OpGen in June 2013 as Vice President, Research and Development and was promoted to Senior Vice President,Research and Development in October 2014. Dr. Walker’s responsibilities include leading the development of genomic technologies and new productssupporting molecular diagnostics for infectious diseases. Prior to joining OpGen, Dr. Walker held senior R&D leadership roles at Pfizer Inc. (NYSE: PFE),from January 2011 to April 2012, at Duke University and The Biomarker Factory, from February 2009 to December 2010, at GlaxoSmithKline plc (NYSE:GSK), from January 2001 to September 2009, and at Becton, Dickinson and Company (NYSE: BDX), from March 1998 to December 2000. Dr. Walkerreceived his Ph.D. in Biophysical Chemistry from the University of Rochester with postdoctoral training in Biophysical Chemistry at the University ofCalifornia, Berkeley.Section 16(a) Beneficial Ownership Reporting ComplianceSection 16(a) of the Securities Exchange Act of 1934, as amended, requires the Company’s officers and directors and persons who own more than 10% of theCompany’s outstanding common stock to file with the SEC initial reports of ownership and reports of changes in ownership of common stock and any otherequity securities of the Company. Directors, officers, and greater than 10% stockholders are required by SEC regulations to furnish the Company with copiesof all Section 16(a) forms they file. Based solely on a review of the Company’s records and written representations by the persons required to file suchreports, all filing requirements of Section 16(a) were satisfied with respect to the 2016 fiscal year, except for one late filing for Timothy C. Dec to report thevesting of restricted stock units, which was filed on Form 5 on February 10, 2017.Code of EthicsWe have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executiveofficer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A current copy of the code is posted onthe Corporate Governance section of our website, which is located at www.opgen.com. If we make any substantive amendments to, or grant any waivers from,the code of business conduct and ethics for any officer, we will disclose the nature of such amendment or waiver on our website or in a Current Report onForm 8‑K.Communications with the Board of DirectorsStockholders who want to communicate with members of the Board, including the independent directors, individually or as a group, should address theircommunications to the Board, the Board members or the Board committee, as the case may be, and send them to c/o Chair of the Audit Committee, OpGen,Inc., 708 Quince Orchard Road, Suite 205, Gaithersburg, MD 20878. The Chair of the Audit Committee will forward all such communications directly to suchBoard members. Any such communications may be made on an anonymous and confidential basis.There have been no changes to the procedures by which interested parties may communicate with the Board.Audit Committee Financial ExpertMessrs. Atwood and D’Andrea and Dr. Rubin serve on the Audit Committee, which is chaired by Mr. D’Andrea. Our Board has determined that each memberof the Audit Committee is “independent” and “financially literate” for Audit Committee purposes as such terms are defined in the rules of the SEC and theapplicable rules of The NASDAQ Stock Market. Mr. D’Andrea is currently identified as the “audit committee financial expert” as defined in the rules of theSEC.61 Item 11. Executive CompensationThis section discusses the material components of the executive compensation program for our executive officers who are named in the “SummaryCompensation Table” below. In 2016, our named executive officers were Evan Jones, our Chief Executive Officer, Timothy Dec, our Chief Financial Officerand Vadim Sapiro, our Chief Information Officer, and Kevin Krenitsky, our former President.Summary Compensation TableThis table provides disclosure, for fiscal years 2016 and 2015 for the named executive officers, who are (1) any individual serving in the office of ChiefExecutive Officer during any part of 2016 and (2) the Company’s two most highly compensated officers, other than the Chief Executive Officer, who wereserving in such capacity on December 31, 2016, and one named executive officer for whom disclosure would be provided but for the fact that he was notserving as an executive officer at December 31, 2016. Named Executive Officer andPrincipal Position Year Salary ($) Bonus (2)($) Stock Awards(1)($) OptionAwards (1)($) Non-Equity IncentivePlan Compensation($) All OtherCompensation ($) Total ($) Evan Jones 2016 $316,538 $- $- $499,352 $- $- $815,890 Chief Executive Officer 2015 $190,000 $- $- $843,260 $- $- $1,033,260 Timothy Dec 2016 $273,462 $50,000 $- $44,996 $- $- $368,458 Chief Financial Officer 2015 $182,050 $- $42,500 $318,226 $- $- $542,776 Vadim Sapiro 2016 $280,385 $50,500 $- $29,997 $- $- $360,882 Chief Information Officer 2015 $275,000 $- $- $54,375 $- $- $329,375 Kevin Krenitsky, M.D. 2016 $233,263 $61,000 $- $44,996 $- $53,364 (5)$392,623 Former President (3) 2015 $194,950 $- $85,000 $1,006,087 $- $10,891 (4)$1,296,928 (1)The “Stock Awards column reflects the grant date fair value for all restricted stock units awarded under the 2015 Plan during 2016. The “OptionAwards” column reflects the grant date fair value for all stock option awards granted under the 2015 Plan or the 2008 Plan during 2016 and 2015,respectively, except for Mr. Jones the 2016 stock option grant was made outside of the 2015 Plan, subject to stockholder approval that was obtainedon June 22, 2016. These amounts are determined in accordance with FASB Accounting Standards Codification 718 (ASC 718), without regard to anyestimate of forfeiture for service vesting. Assumptions used in the calculation of the amounts in these columns for 2016 and 2015 are included infootnote 8 to the Company’s consolidated audited financial statements included in this Annual Report.(2)Bonus amounts represent 2015 earned amounts that were not finalized until after the 2015 annual report and paid in 2016. No bonuses were earned for2016.(3)Dr. Krenitsky resigned from his position on August 31, 2016.(4)Represents relocation expenses for which the Company reimbursed Dr. Krenitsky during the year ended December 31, 2015.(5)Represents severance related expenses.62 Outstanding Equity Awards at Fiscal Year EndThe following table shows the outstanding equity awards held by the named executive officers as of December 31, 2016. OPTION AWARDS STOCK AWARDSName (1) Number ofSecuritiesUnderlyingUnexercisedOptionsExercisable (1) Number ofSecuritiesUnderlyingUnexercisedOptionsUnexercisable EquityIncentivePlan Awards:Number ofSecuritiesUnderlyingUnexercisedUnearned Options OptionExercisePrice ($) OptionExpirationDate Number ofShares ofStock thathave notVested Market Valueof Sharesof Stock thathave notVested ($) EquityIncentivePlan Awards:Number ofUnearnedShares, Unitsor Other Rightsthat havenot Vested EquityIncentivePlan Awards:Market orPayout Valueof UnearnedShares, Unitsor other Rightsthat havenot VestedEvan Jones(2) 89 - - 79.05 7/23/2018 - - - - 1,847 - - 110.68 9/21/2020 - - - - 108,896 65,339 - 0.05 4/24/2024 - - - - 100,000 100,000 - 0.61 10/23/2024 - - - - - 766,500 - 1.55 4/28/2026 - - -Timothy Dec(3) 50,015 64,305 - 6.00 5/4/2025 - - - - 15,625 34,375 - 1.70 11/10/2025 - - - - - 60,000 - 1.55 6/13/2026 - - - - - - - - - 18,750 21,563 - -Vadim Sapiro(4) 64 - - 7.91 3/23/2022 - - - - 918 - - 7.91 3/23/2022 - - - - 237 16 - 7.91 2/12/2023 - - - - 127 - - 7.91 2/12/2023 - - - - 514 119 - 7.91 7/25/2023 - - - - 2,691 898 - 0.05 4/24/2024 - - - - 25,000 25,000 - 0.61 10/23/2024 - - - - 25,000 - - 6.00 5/4/2025 - - - - - 40,000 - 1.55 6/13/2026 - - - -Kevin Krenitsky(5) 95,266 - - 6.00 2/28/2017 - - - - 20,833 - - 1.70 2/28/2017 - - - - (1)The standard vesting schedule for all stock option grants is vesting over four years with twenty-five percent (25%) vesting on the first anniversary ofthe date of grant and six and one-quarter percent (6.25%) vesting on the last day of the next fiscal quarter over three years.(2)The stock option awards made to Mr. Jones have the vesting schedule set forth in footnote (1) and were awarded on July 23, 2008 (89 shares), February15, 2011 (1,847 shares), April 24, 2014 (174,235 shares), October 23, 2014 (200,000 shares) and April 28, 2016 (766,500 shares).(3)Mr. Dec was granted stock option awards on May 4, 2015 (114,320 shares), November 10, 2015 (50,000 shares), and June 13, 2016 (60,000shares). One-forty-eighth of Mr. Dec’s stock option awards granted on May 4, 2015 vested on the one month anniversary of the date of grant andthereafter vest over four years with twenty-five percent (25%) vesting on the first yearly anniversary of the date of grant and six and one-quarterpercent (6.25%) vesting on the last day of the next fiscal quarter over three years. Mr. Dec’s stock option awards granted on November 10, 2015 andJune 13, 2016 have the vesting schedule set forth in footnote (1). Mr. Dec was granted restricted stock units on November 10, 2015. Twenty-fivepresent (25%) of the entire Restricted Stock Units Award vest on the first four anniversaries of the date of grant.(4)The stock option awards granted to Mr. Sapiro on March 23, 2012 (64 shares and 918 shares), February 12, 2013 (253 shares), July 25, 2013 (633shares), October 23, 2014 (50,000 shares) and June 13, 2016 (40,000 shares) have the vesting schedule set forth in footnote (1). The stock optionaward granted to Mr. Sapiro on February 12, 2013 for 127 shares vested in full on the first anniversary of the date of grant, February 12, 2014. Thestock option award granted to Mr. Sapiro on April 24, 2014 for 3,589 shares is vesting over four years with twenty-five percent (25%) vesting onDecember 31, 2014 and six and one-fourth percent (6.25%) vesting quarterly thereafter in equal proportions over the remaining three years. The stockoption granted to Mr. Sapiro on May 4, 2015 vested quarterly over the first year following the date of grant.(5)Dr. Krentisky was granted stock option awards on May 4, 2015 (381,067 shares), November 10, 2015 (100,000 shares), and June 13, 2016 (60,000shares). On August 31, 2016, Dr. Krenitsky resigned from his position as President. The Company entered into a Confidential Separation Agreementand General Release with Dr. Krenitsky on September 1, 2016 (the “Separation Agreement”). Pursuant to the Separation Agreement, the vesting ofcertain stock options set forth in this table was accelerated and Dr. Krenitsky had until February 28, 2017 to exercise his vested stock options. As ofDecember 31, 2016, 116,099 options vested, including 95,266 options from the May 4, 2015 award, 20,833 options from the November 10, 2015award and no options from the June 13, 2016 award.63 Equity Compensation Plan InformationThe following table shows, as of December 31, 2016, the Company’s equity compensation plans under which the Company’s equity securities are authorizedfor issuance: Plan Category Number of securitiesto be issued uponexercise ofoutstandingoptions, warrantsand rights(1) Weighted averageexercise price ofoutstandingoptions,warrants andrights(2) Number ofsecuritiesremaining availablefor future issuance Equity compensation plans approved by security holders 2,996,410 $1.76 669,651 Equity compensation plans not approved by security holders — — — Total 2,996,410 $1.76 669,651 (1)Includes 18,750 outstanding restricted stock units for which there is no exercise price.(2)Includes the weighted-average exercise price of stock options only.Employee Incentive Plans2008 PlanOur 2008 Stock Option and Restricted Stock Plan, as amended (the “2008 Plan”), was approved by our Board and stockholders in April 2008; subsequentincreases in the number of shares available for awards under the 2008 Plan were approved by our Board and stockholders in January 2009, February 2011,March 2012, December 2012, April 2014 and October 2014. A total of 1,447,791 shares of our common stock are reserved for issuance under the 2008 Plan.The Compensation Committee of our Board administers the 2008 Plan. Subject to the terms of the 2008 Plan, the Compensation Committee has thediscretionary authority to interpret the 2008 Plan; determine eligibility for and grant awards; determine, modify or waive the terms and conditions of anyaward; prescribe forms, rules and procedures; and otherwise do all things necessary to carry out the purposes of the 2008 Plan. Awards under the 2008 Planmay be granted to key employees of, and consultants to and advisors to the Company or its affiliates. Awards may also be made to members of our Board.The 2008 Plan provides for the grant of stock options and restricted stock awards. The Compensation Committee determines the time or times at which astock option will vest or become exercisable and the terms on which such option will remain exercisable. The Compensation Committee determines theconditions and restrictions and purchase price, if any, for grants or sales or restricted stock to plan participants. The Compensation Committee may also atany time accelerate the vesting or exercisability of an award.Under the 2008 Plan, in the event of any dissolution or liquidation of the Company, the sale of all or substantially all of the Company's assets, or the mergeror consolidation of the Company where the Company is not the surviving entity or which results in the acquisition of all or substantially all of theCompany's then outstanding common stock, the committee may: (a) provide for the assumption or substitution of some or all of the outstanding awards; (b)provide for a cash-out payment; or (c) in the case there is no assumption, substitution or cash-out, provide that all awards not exercised or awards providingfor the future delivery of common stock will terminate upon the closing of the transaction.The Compensation Committee may amend the 2008 Plan or any outstanding award at any time for any purpose permitted by law, and may at any timeterminate the 2008 Plan as to any future grants of awards; provided, that otherwise expressly provided in the 2008 Plan, no amendment may impair the rightsof a participant without the affected participant's consent unless the committee expressly reserved the right to do so at the time of an award. Following our 2015 Equity Incentive Plan (the “2015 Plan”), becoming effective, no further grants have been or will be made under our 2008 Plan.2015 PlanThe 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of the Internal Revenue Code (the “Code”) toemployees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides for grants ofrestricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directors andconsultants. The 2015 Plan was amended by the Compensation Committee in64 February 2017 to revise the provisions with respect to net settlement of awards in response to change in regulations, and to establish standard periods forexercise of vested stock options following termination of service events. Administration. The Compensation Committee administers the 2015 Plan, including the determination of the recipient of an award, the number of shares oramount of cash subject to each award, whether an option is to be classified as an incentive stock option or non-qualified stock option, and the terms andconditions of each award, including the exercise and purchase prices and the vesting and duration of the award. Our Board may appoint one or more separatecommittees of our Board, each consisting of one or more members of our Board, to administer our 2015 Plan with respect to employees who are not subject toSection 16 of the Exchange Act. Subject to applicable law, our Board may also authorize one or more officers to designate employees, other than employeeswho are subject to Section 16 of the Exchange Act, to receive awards under our 2015 Plan and/or determine the number of such awards to be received by suchemployees subject to limits specified by our Board.Authorized shares. Under our 2015 Plan, the aggregate number of shares of our common stock authorized for issuance may not exceed (1) 1,355,000 plus (2)the sum of the number of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan's effective date that are subsequently forfeited orterminated for any reason before being exercised or settled, plus the number of shares subject to vesting restrictions under the 2008 Plan on the 2015 Plan'seffective date that are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will beautomatically increased on the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equalto the lesser of (i) 4% of the outstanding shares of our common stock on the last day of the immediately preceding fiscal year, and (ii) another lesser amountdetermined by our Board. Accordingly, on January 1, 2017, the number of shares authorized for issuance under the 2015 Plan increased by 1,012,171 sharessuch that, as of March 31, 2017, an aggregate of 3,928,390 shares are authorized for issuance under the 2015 Plan, with 1,148,050 shares remaining availablefor future awards under the 2015 Plan. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participantbecause such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actually been issued shall notagain become available unless forfeited. No more than 4,000,000 shares may be delivered upon the exercise of incentive stock options granted under the2015 Plan. Types of awardsStock options. A stock option is the right to purchase a certain number of shares of stock, at a certain exercise price, in the future. Under our 2015 Plan,incentive stock options and non-qualified options must be granted with an exercise price of at least 100% of the fair market value of our common stock onthe date of grant. Incentive stock options granted to any holder of more than 10% of our voting shares must have an exercise price of at least 110% of the fairmarket value of our common stock on the date of grant. The stock option agreement specifies the date when all or any installment of the option is to becomeexercisable. Payment of the exercise price may be made in cash or, if provided for in the stock option agreement evidencing the award, (1) by surrendering, orattesting to the ownership of, shares which have already been owned by the optionee, (2) by delivery of an irrevocable direction to a securities broker to sellshares and to deliver all or part of the sale proceeds to us in payment of the aggregate exercise price, (3) by a "net exercise" arrangement, or (4) by any otherform that is consistent with applicable laws, regulations and rules.Restricted stock. Restricted stock is a share award that may be subject to vesting conditioned upon continued service, the achievement of performanceobjectives or the satisfaction of any other condition as specified in a restricted stock agreement. Participants who are granted restricted stock awards generallyhave all of the rights of a stockholder with respect to such stock, other than the right to transfer such stock prior to vesting.Restricted stock units. Restricted stock units give recipients the right to acquire a specified number of shares of stock at a future date upon the satisfaction ofcertain conditions, including any vesting arrangement, established by our Compensation Committee and as set forth in a restricted stock unitagreement. Unlike restricted stock, the stock underlying restricted stock units will not be issued until the restricted stock units have vested and are settled,and recipients of restricted stock units generally will have no voting or dividend rights prior to the time the vesting conditions are satisfied and the award issettled.Dividend equivalents. At our Compensation Committee's discretion, performance-based restricted stock or restricted stock unit awards may provide for theright to dividend equivalents. Subject to the terms of the 2015 Plan, our Compensation Committee will determine the terms and conditions of any stock unitaward, which will be set forth in a stock unit agreement to be entered into between us and each recipient.Stock appreciation rights. Stock appreciation rights typically will provide for payments to the recipient based upon increases in the price of our commonstock over the exercise price of the stock appreciation right. The exercise price of a stock appreciation right will be determined by our CompensationCommittee, which shall not be less than the fair market value of our common stock on the date of65 grant. Our Compensation Committee may elect to pay stock appreciation rights in cash or in common stock or in a combination of cash and common stock.Performance-based awards. Awards under our 2015 Plan may be made subject to the attainment of performance goals.Other plan featuresNo Transfer. Unless the agreement evidencing an award expressly provides otherwise, no award granted under the 2015 Plan may be transferred in anymanner (prior to the vesting and lapse of any and all restrictions applicable to shares issued under such award), other than by will or the laws of descent anddistribution, provided, however, that an incentive stock option may be transferred or assigned only to the extent consistent with Section 422 of the Code.Adjustments. In the event of a recapitalization, stock split or similar capital transaction, our Compensation Committee will make appropriate and equitableadjustments to the number of shares reserved for issuance under the 2015 Plan, the limitations regarding the total number of shares underlying awards givento an individual participant in any calendar year, the number of shares that can be issued as incentive stock options, the number of shares subject tooutstanding awards and the exercise price under each outstanding option or stock appreciation right.Change in Control. If we are involved in a merger or other reorganization, outstanding awards will be subject to the agreement of merger orreorganization. Such agreement will provide for (1) the continuation of the outstanding awards by us if we are the surviving corporation, (2) the assumptionor substitution of the outstanding awards by the surviving corporation or its parent or subsidiary, (3) immediate vesting, exercisability and settlement of theoutstanding awards followed by their cancellation, or (4) settlement of the intrinsic value of the outstanding awards (whether or not vested or exercisable) incash, cash equivalents, or equity (including cash or equity subject to deferred vesting and delivery consistent with the vesting restrictions applicable to suchaward or the underlying shares) followed by cancellation of such awards.Termination or Amendment. Our Board may amend or terminate the 2015 Plan at any time, subject to stockholder approval where required by applicablelaw. Any amendment or termination may not materially impair the rights of holders of outstanding awards without their consent. No incentive stock optionmay be granted after the tenth anniversary of the date the 2015 Plan was adopted by our Board.Effective Date. The 2015 Plan was initially adopted by our Board and subsequently approved by our stockholders in April 2015. The 2015 Plan becameeffective on May 4, 2015. Awards may be granted under the 2015 Plan until April 1, 2025.Compensation ConsultantIn July 2015, the Compensation Committee engaged Radford, an Aon Hewitt company, to provide information, consulting services and recommendations tothe Compensation Committee in (1) developing a peer group of companies used to conduct its executive compensation assessment and evaluate itscompensation philosophy and (2) assessing the Company’s executive compensation program, including cash and equity short term and long termcompensation of the named executive officers. In August 2015, the Compensation Committee approved the following peer group to be used by theCompensation Committee as part of the mix of information for 2016 executive compensation determinations: Accelerate Diagnostics, Inc., AkersBiosciences, Inc., Atossa Genetics Inc., Biocept, Inc., BG Medicine, Inc., CareDx, Inc., Chembio Diagnostics, Inc., CombiMatrix Corporation, ERBADiagnostics, Inc., Genmark Diagnostics, Inc., Great Basin Scientific, Inc., HTG Molecular Diagnostics, Inc., Invitae Corporation, Nanosphere, Inc., NanoStringTechnologies, Inc., Psychemedics Corporation, Roka Bioscience, Inc., Signal Genetics, Inc., T2Biosystems, Inc., TearLab Corporation, Trovagene, Inc.,Veracyte, Inc. and Vermillion, Inc.The Compensation Committee determined that Radford is independent of management and of the Company. Radford provides, data analysis andrecommendations to the Compensation Committee as part of its executive compensation determinations. Employment Agreements with Named Executive OfficersThe Company has entered into employment agreements with, and provides post-employment benefits to, our named executive officers as follows:Evan Jones - On March 3, 2014, we entered into an amended and restated employment agreement with Evan Jones, our Chief Executive Officer. Theagreement provides that Mr. Jones will serve as our Chief Executive Officer at the equivalent of seventy percent of a full-time commitment. His initial basesalary of $190,000 reflected that pro rata adjustment. When he assumed the role of Chief Executive Officer, he agreed to receive base compensation for all ofhis positions through the issuance of restricted stock units,66 in lieu of cash salary, for the period from October 25, 2013 to June 30, 2014. In addition, Mr. Jones received an award of stock options to acquire three andone-half percent (3.5%) of the fully diluted equity of the Company following the closing of the 2014 Series A Convertible Preferred Stock offering,completed in February, April and May 2014. Mr. Jones receives annual bonus opportunities based on performance goals determined by our Board. Thecurrent maximum target opportunity is seventy percent of annual base salary. Under his employment agreement, Mr. Jones waived his rights to participate inany fringe benefit plans offered to the Company's employees, except for participation in the Company's 401(k) plan. Our agreement with Mr. Jones alsoincludes standard confidentiality, general release and other provisions.Timothy C. Dec - On April 17, 2015, we entered into an employment agreement with Timothy C. Dec, our Chief Financial Officer, with an initial base salaryof $260,000 and annual bonus opportunities based on performance goals determined by our Board, with a current target bonus of thirty percent (30%) ofannual base salary. In addition, Mr. Dec received an award of stock options to acquire three-quarters of one percent (0.75%) of the fully diluted equity of theCompany. The stock options will vest in equal monthly installments for an interim period, expected to last 90 days, and then vest in accordance with theCompany's standard vesting practices. The agreement provides for the acceleration of the award if Mr. Dec's employment is terminated in connection with achange in control, if the award is not continued, assumed or substituted and would otherwise terminate and expire upon the change in control. In addition,the agreement provides for acceleration of the award, if the award is continued, assumed or substituted for in connection with a change in control, and, duringthe six (6) month period after the effective date of the change in control, Mr. Dec's employment with the Company is terminated without cause.Vadim Sapiro – On January 27, 2012, we entered into an executive change in control and severance benefits agreement with Vadim Sapiro, our ChiefInformation Officer. Under the agreement, upon any termination of Mr. Sapiro’s employment without "cause" that constitutes a "separation from service"under Section 409A of the Internal Revenue Code, he will receive severance compensation equal to his base salary at the time of termination for six months.The agreement provides for the acceleration of the vesting, or lapse of forfeiture restrictions on his outstanding equity awards that were granted on or prior toDecember 31, 2011, in the event of termination of employment in connection with a change in control. In addition, the agreement provides that, for 12months following a change in control, if Mr. Sapiro terminates his employment with the Company for good reason and such termination constitutes a“separation from service” under Section 409A of the Code, Mr. Sapiro will receive severance compensation equal to his base salary at the time of terminationfor six months. On November 1, 2013, we amended the executive change in control and severance benefits agreement to add a provision providing theCompany the ability to terminate the agreement upon sixty days (60) prior written notice.Kevin Krenitsky - On April 17, 2015, we entered into an executive employment, change in control and severance benefits agreement with Kevin Krenitsky,our President. Under the agreement, Dr. Krenitsky worked 10% of his professional time between April 17 and May 31, 2015 and joined the Company fulltime in June 2015. His base salary is $325,000 and annual bonus opportunity, based on performance goals determined by our Board, is currently a targetbonus of 40% of annual base salary. In addition, Dr. Krenitsky received an award of stock options to acquire two and one-half percent (2.5%) of the fullydiluted equity of the Company. Under the agreement, upon any termination of Dr. Krenitsky's employment without "cause" that constitutes a "separation fromservice" under Section 409A of the Code, he will receive severance compensation equal to his base salary at the time of termination for six months. Theagreement provides for the acceleration of the vesting, or lapse of forfeiture restrictions on his then-outstanding equity awards in the event of termination ofemployment in connection with a change in control, if the then-outstanding equity awards are not continued, assumed or substituted and would otherwiseterminate and expire upon the change in control. In addition, the agreement provides that, for 12 months following a change in control, if Dr. Krenitskyterminates the agreement for good reason or the Company or a successor terminates the agreement without cause, Dr. Krenitsky will receive severancepayments for six months and all outstanding equity awards will vest, or have lapse of forfeiture restrictions, as applicable, as of the effective date of thetermination of employment.On September 1, 2016, the Company and Dr. Krenitsky entered into a Separation Agreement and General Release (the “Separation Agreement”), whichbecame effective on September 8, 2016. The Separation Agreement provided that the Company would pay separation payments to Dr. Krenitsky consistingof three months’ base salary, coverage of health insurance premiums for three months and acceleration of vesting of certain stock option and restricted stockunit awards, and an extended period to exercise vested stock options. The separation payments are consideration for the Company’s receipt of a release ofemployment-related and other claims, liabilities and causes of action, and confirmation of Dr. Krenitsky’s continued compliance with various restrictivecovenants relating to, among other things, protection of the Company’s confidential information, and non-competition, non-solicitation and non-disparagement covenants. All payments were made as of December 31, 2016.67 For purposes of the employment and severance agreements, the following terms have the following meanings (where applicable): •“cause” means: (i) the executive's commission of a felony; (ii) any act or omission of executive constituting dishonesty, fraud, immoral ordisreputable conduct that causes material harm to the Company; (iii) executive's violation of Company policy that causes material harm to theCompany; (iv) executive's material breach of any written agreement between the executive and the Company which, if curable, remainsuncured after notice; or (v) executive's breach of fiduciary duty. The termination of executive's employment as a result of the death ordisability is not deemed to be a termination without cause. •“change in control” means (a) a merger or consolidation in which (i) the Company is a constituent party, or (ii) a subsidiary of the Company is aconstituent party and the Company issues shares of its capital stock pursuant to such merger or consolidation, except any such merger orconsolidation involving the Company or a subsidiary in which the shares of capital stock of the Company outstanding immediately prior tosuch merger or consolidation continue to represent, or are converted into or exchanged for shares of capital stock that represent, immediatelyfollowing such merger or consolidation, at least a majority, by voting power, of the capital stock of (1) the surviving or resulting corporation or(2) if the surviving or resulting corporation is a wholly owned subsidiary of another corporation immediately following such merger orconsolidation, the parent corporation of such surviving or resulting corporation (taking into account all equity on a fully diluted and convertedbasis); or (b) the sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions, by theCompany or any subsidiary of the Company of all or substantially all the assets of the Company and its subsidiaries taken as a whole, or thesale or disposition (whether by merger or otherwise) of one or more subsidiaries of the Company if substantially all of the assets of theCompany and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, except where such sale, lease, transfer, exclusivelicense or other disposition is to a wholly owned subsidiary of the Company; provided that to the extent necessary for compliance with Section409A of the Internal Revenue Code, no transaction will be a change in control for these purposes unless such transaction is also a change in theownership or effective control of the Company, or a change in the ownership of a substantial portion of the Company's assets as described inTreasury Regulation Section 1.409A-3(i)(5). •"good reason" means any of the following, without the executive's consent: (i) material diminution of executive's responsibilities or duties(provided that the acquisition of the Company and subsequent conversion of the Company to a division or unit of the acquiring company willnot by itself be deemed to be a diminution of executive's responsibilities or duties); (ii) material reduction in the level of executive's base salary(and any such reduction will be ignored in determining executive's base salary for purposes of calculating the amount of severance pay); (iii)relocation of the office at which executive is principally based to a location that is more than fifty (50) miles from the location at whichexecutive performed his or her duties immediately prior to the effective date of a change in control; (iv) failure of a successor in a change incontrol to assume the agreement; or (v) the Company's material breach of any written agreement between executive and the Company.Notwithstanding the foregoing, any actions taken by the Company to accommodate a disability of executive or pursuant to the Family andMedical Leave Act shall not be a good reason for purposes of the agreement. Additionally, before executive may terminate employment for agood reason, executive must notify the Company in writing within thirty (30) days after the initial occurrence of the event, condition orconduct giving rise to good reason, the Company must fail to remedy or cure the alleged good reason within the thirty (30) day period afterreceipt of such notice if capable of being cured within such thirty-day period, and, if the Company does not cure the good reason (or it isincapable of being cured within such thirty-day period), then executive must terminate employment by no later than thirty (30) days after theexpiration of the last day of the cure period (or, if the event condition or conduct is not capable of being cured within such thirty-day period,within thirty (30) days after initial notice to the Company of the violation). Transferring executive's employment to a successor is not itselfgood reason to terminate employment under the agreement, provided, however, that subparagraphs (i) through (v) above shall continue toapply to executive's employment by the successor. This definition is intended to constitute a "substantial risk of forfeiture" as defined underTreasury Regulation 1.409A-1(d).Director CompensationSince May 2015, each non-employee director receives an annual cash retainer of $25,000, payable quarterly, plus additional annual cash compensation forcommittee chairs ($15,000 for Audit Committee, $10,000 for Compensation Committee and $7,500 for Compliance Committee) and for committee members($7,000 for Audit Committee, $5,000 for Compensation Committee and $3,500 for Compliance Committee). In addition, each new director receives an initialstock option grant to purchase 30,000 shares of common stock and each non-employee director receives an annual stock option grants to purchase 12,500shares of common stock. All such awards are made under the 2015 Plan. The annual stock option awards may be pro-rated in the first year of servicedepending on when the non-employee director joins the Board. This compensation program was reviewed by the Compensation Committee in February2017, and the determination was made to continue to the program without change.68 Evan Jones, Chairman of the Board and CEO, does not receive additional compensation for service on our Board. See "Summary Compensation Table" forhis 2016 compensation. Compensation for the non-employee directors for the year ended December 31, 2016 was: Name Fees Earned orPaid in Cash($) Option Awards($)(1) All OtherCompensation($) Total ($) Brian G. Atwood $36,000 $7,589 $- $43,589 Harry J. D'Andrea $24,167 $26,114 $- $50,281 Timothy J.R. Harris $33,500 $7,589 $- $41,089 Laurence R. McCarthy $37,500 $7,589 $- $45,089 David M. Rubin (2) $- $- $- $- Misti Ushio $38,500 $7,589 $- $46,089 (1)The “Option Awards” column reflects the grant date fair value for all stock option awards granted under the 2015 Plan during 2016. These amountsare determined in accordance with FASB Accounting Standards Codification 718 (ASC 718), without regard to any estimate of forfeiture for servicevesting. Assumptions used in the calculation of the amounts are included in footnote 8 to the Company’s consolidated audited financial statementsincluded in this Annual Report. (2)As managing director of Merck GHI, Dr. Rubin is precluded from receiving compensation for serving as a director of OpGen, Inc. 69 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder MattersSecurity Ownership of Certain Beneficial Owners and ManagementThe number of shares of the Company’s common stock outstanding at the close of business on March 20, 2017 was 27,377,490 shares. The following tablesets forth the beneficial ownership of the Company’s common stock as of March 20, 2017 by each Company director and named executive officer, by alldirectors and executive officers as a group, and by each person who owned of record, or was known to own beneficially, more than 5% of the outstandingshares of our common stock. Beneficial ownership is determined in accordance with Rule 13d-3 under the Exchange Act. In computing the number of sharesbeneficially owned by a person or a group and the percentage ownership of that person or group, shares of our common stock subject to options and warrantscurrently exercisable or exercisable within 60 days after March 20, 2017 are deemed outstanding, but are not deemed outstanding for the purpose ofcomputing the percentage ownership of any other person. To the knowledge of the directors and executive officers of the Company, as of December 31,2016, there are no persons and/or companies who or which beneficially own, directly or indirectly, shares representing more than 5% of the voting rightsattached to all outstanding shares of the Company, other than as set forth below. Unless otherwise indicated, the address of each beneficial owner listedbelow is c/o OpGen, Inc., 708 Quince Orchard Road, Suite 205, Gaithersburg, MD 20878. Name and Address of Beneficial Owner Number of Sharesof Common Stock Percentage ofOutstandingCommon Shares 5% Stockholders Merck Global Health Innovation Fund, LLC (1) 8,364,270 27.58%One Merck Drive 2W116 Whitehouse Station, NJ 08889 jVen Capital, LLC (2) 4,988,963 17.47%11009 Cripplegate Road Potomac, MD 20854 Versant Ventures III, LLC (3) 3,034,373 10.89%One Sansome Street Suite 3630 San Francisco, CA 94104 Directors and Executive Officers Evan Jones (4) 5,566,807 19.19%Brian G. Atwood (5) 3,046,873 10.93%Harry D’Andrea (6) 22,500 * Timothy J.R. Harris, Ph.D., D.Sc. (7) 129,461 * Laurence R. McCarthy, Ph.D. (8) 54,552 * David M. Rubin, Ph.D. (9) - - Misti Ushio, Ph.D. (10) 12,500 * Kevin Krenitsky, M.D. (11) 51,537 * Timothy C. Dec (12) 166,663 * Vadim Sapiro (13) 82,908 * All Directors and Executive Officers as a group 9,600,198 31.75%(13 individuals) (14) *Constitutes less than 1%(1)Consists of 5,413,449 shares of common stock and (ii) currently exercisable warrants to acquire an additional 2,950,821 shares of common stock.(2)Consists of (i) 3,805,604 shares of common stock, and (ii) currently exercisable warrants to acquire an additional 1,183,359 shares of common stock.(3)Consists of (i) 2,539,214 and 14,997 shares of common stock beneficially owned by Versant Venture Capital III, L.P. (“Versant Capital III”) andVersant Side Fund III, L.P. (“Versant SF III”), respectively, and (ii) currently exercisable warrants to acquire an additional 477,342 and 2,820 shares ofcommon stock owned by Versant Capital III and Versant SF III, respectively. Versant Ventures III, LLC is the sole general partner of Versant Capital IIIand Versant SF III.70 (4)Consists of (i) 3,805,604 shares of common stock and currently exercisable warrants to acquire an additional 1,183,359 shares of common stockbeneficially owned by jVen Capital, LLC, (ii) 131,156 shares of common stock and currently exercisable warrants to acquire an additional 20,841shares of common stock owned by Mr. Jones’ spouse, and (iii) stock options to purchase 425,847 shares of common stock that are currently vested orthat will become vested within 60 days. Mr. Jones is a managing member of jVen Capital, LLC and has voting and investment authority over theshares owned by that entity (see footnote 2 above). (5)Consists of (i) 2,539,214 and 14,997 shares of common stock beneficially owned by Versant Capital III and Versant SF III, respectively, (ii) currentlyexercisable warrants to purchase an additional 477,342 and 2,820 shares of common stock beneficially owned by Versant Capital III and Versant SFIII, respectively, and (iii) stock options to purchase 12,500 shares of common stock that are currently vested or that will become vested within 60 days.Mr. Atwood is a Managing Director of Versant Ventures III, LLC, the sole general partner of Versant Capital III and Versant SF III. Mr. Atwood hasshared voting and investment authority over the shares owned by those entities (see footnote 3 above).(6)Consists of stock options to purchase 22,500 shares of common stock that are currently vested or that will become vested within 60 days. (7)Consists of (i) 50,116 shares of common stock, (ii) currently exercisable warrants to acquire an additional 39,187 shares of common stock, and (iii)stock options to purchase 40,158 shares of common stock that are currently vested or that will become vested within 60 days.(8)Consists of stock options to purchase 54,552 shares of common stock that are currently vested or that will become vested within 60 days. (9)Dr. Rubin is the managing director of Merck GHI, but does not have nor share voting power over the shares of our common stock owned by MerckGHI.(10)Consists of stock options to purchase 12,500 shares of common stock that are currently vested or that will become vested within 60 days. (11)Consists of (i) 10,416 shares of common stock and (ii) currently exercisable warrants to acquire an additional 41,121 shares of common stock. OnAugust 31, 2016, Dr. Krenitsky resigned from his position as President. The Company entered into the Separation Agreement with Dr. Krenitsky onSeptember 1, 2016. Pursuant to the Separation Agreement, Dr. Krenitsky had until February 28, 2017 to exercise his vested stock options and theunexercised expired.(12)Consists of (i) 53,966 shares of common stock, (ii) currently exercisable warrants to acquire an additional 36,787 shares of common stock, and (iii)stock options to purchase 75,910 shares of common stock that are currently vested or that will become vested within 60 days.(13)Consists of (i) 15,115 shares of common stock, (ii) currently exercisable warrants to acquire an additional 9,837 shares of common stock, and (iii)stock options to purchase 57,956 shares of common stock that are currently vested or that will become vested within 60 days.(14)In addition to the beneficial ownership described in footnotes (4) through (13), includes (i) 122,405 shares of common stock, (ii) currently exercisablewarrants to acquire an additional 91,804 shares of common stock, and (iii) stock options to purchase 252,188 shares of common stock that arecurrently vested or that will become vested within 60 days.Item 13. Certain Relationships and Related Person Transactions, and Director IndependenceOther than compensation arrangements, we describe below the transactions and series of similar transactions, during our last two fiscal years, to which wewere a party or will be a party, in which: •the amounts involved exceeded or will exceed the lesser of $120,000 or one percent of the average of the Company's total assets at year end forthe past two completed fiscal years; and •any of our directors, executive officers or holders of more than 5% of our capital stock, or any member of the immediate family of the foregoingpersons, had or will have a direct or indirect material interest.Compensation arrangements for our directors and named executive officers are described elsewhere in this Annual Report.Contractual RelationshipsIn December 2013, we purchased a BioMark HD DNA detection system and related instruments from Fluidigm Corporation for a purchase price of $221,000.In March 2014, we entered into a supply agreement with Fluidigm under which Fluidigm supplies us with its microfluidic test platform for use inmanufacturing our Acuitas MDRO Gene Test. In 2015, we entered into a collaboration agreement with Fluidigm that also extended the term of the supplyagreement until March 2018. Evan Jones, our Chief Executive Officer and Chairman of the Board, is a director of Fluidigm. The Company paid $183,713related to these agreements in the year ended December 31, 2016. The Company paid $295,442 related to these agreements in the year ended December 31,2015. Under the agreements with Fluidigm, the Company had purchases of $91,399 in the year ended December 31, 2016. The Company had purchases of$370,539 related to these agreements in the year ended December 31, 2015. In addition, we have several capital lease71 arrangements for laboratory equipment manufactured by Fluidigm. Under the capital lease arrangements, we paid Fluidigm $119,919 and $175,475 related toleased equipment in 2015 and 2016, respectively. We believe that our transactions with Fluidigm were on commercially reasonable terms no less favorable tous than could have been obtained from unaffiliated third parties. The terms of our transactions with Fluidigm have been ratified and approved by the Board,without the participation of Mr. Jones. We intend that any future transactions with Fluidigm will be approved by the Board without the participation of Mr.Jones. Mr. Jones has no direct or indirect financial or pecuniary interest in these ordinary course business transactions between OpGen and Fluidigm.In October 2016, the Company entered into an agreement with Merck Sharp & Dohme Corp., a wholly owned subsidiary of Merck, an affiliate of Merck GHI,a principal stockholder of the Company and a related party. Under the agreement, Merck will provide access to its archive of over 200,000 bacterialpathogens. OpGen will initially perform molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision makingusing the Acuitas Lighthouse MDRO Management System, and to speed development of OpGen’s rapid diagnostic platforms. Merck will gain access to thehigh-resolution genotype data for the isolates as well as access to OpGen’s Acuitas Lighthouse informatics to support internal research and developmentprograms. OpGen is required to expend up to $175,000 for the procurement of materials related to the activities contemplated by the agreement. As ofDecember 31, 2016, the Company has incurred $32,270 of procurement costs which have been recognized as research and development expense.In December 2016, the Company entered into an agreement with Healthcare Services & Solutions LLC, an affiliate of Merck GHI in which the Company willprovide research analysis and reports to the third party on behalf of Healthcare Services & Solutions LLC. The agreement is worth up to $150,000, of which$135,000 has been recognized as of December 31, 2016.Sales and Purchases of SecuritiesOn May 19, 2016 and June 27, 2016, the Company offered and sold units in a private offering to members of management and employees and to accreditedinvestors, including Merck GHI and jVen Capital, each unit consisting of either (i) one share of common stock and a detachable stock purchase warrant topurchase an additional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock a detachable stock purchase warrant topurchase an additional 0.75 shares of common stock, at a price of $1.14 per unit. The total net proceeds to the Company, after deducting offeringcommissions and expenses was $9.5 million. The Company is using the proceeds for working capital and general corporate purposes. Pursuant to the privateoffering the Company issued 6,744,127 shares of common stock, 2,309,428 shares of Series A non-voting convertible preferred stock and stock purchasewarrants to acquire an additional 6,790,169 shares of common stock. Each share of non-voting convertible preferred stock was convertible at the option ofthe holder in whole or in part and from time to time into one share of common stock, is entitled to dividends on as “as converted basis” when and if dividendsare issued to common stockholders, and participates in liquidation on a pari passu basis with common stockholders. Holders of the Series A non-votingconvertible preferred stock subsequently converted all 2,309,428 shares of preferred stock into 2,309,428 shares of common stock. The stock purchasewarrants issued as part of the units are exercisable $1.3125 per share beginning 90 days after closing for five years, expiring on May 18, 2021. Evan Jones,our Chief Executive Officer and Chairman of the Board is a managing member of jVen Capital, LLC and has voting and investment authority over the sharesowned by jVen Capital; Timothy Harris, a director of the Company; and Timothy Dec and Vadim Sapiro, officers of the Corporation, were all investors inthese offerings.Policies for Approval of Related Person TransactionsWe have adopted a written policy that transactions with directors, officers and holders of 5% or more of our voting securities and their affiliates, each, arelated person, must be approved by our Audit Committee.Independence of the Board of DirectorsThe Board currently consists of Messrs. Atwood, D’Andrea, and Jones and Drs. Harris, McCarthy, Rubin and Ushio.72 The Company defines “independent” as that term is defined in Rule 5605(a)(2) of the NASDAQ listing standards. For 2016, Messrs. Atwood and D’Andreaand Drs. Harris, McCarthy, Rubin and Ushio qualified as independent and none of them has any material relationship with the Company that might interferewith his or her exercise of independent judgment. Name Audit Committee Compensation Committee Compliance CommitteeEvan Jones Brian G. Atwood X Harry J. D'Andrea Chair Timothy J.R. Harris X XLaurence R. McCarthy X ChairDavid M. Rubin X Misti Ushio Chair X Item 14. Principal Accounting Fees and ServicesAudit FeesCohnReznick LLP has served as the independent registered public accounting firm of the Company since 2013. The following table presents the aggregatefees billed to the Company by CohnReznick LLP for its audits of the Company’s consolidated annual financial statements and other services for the yearsended December 31, 2016 and 2015. 2016 2015 Audit Fees (1) $367,913 $236,844 Audit Related Fees (2) - 471,611 Tax Fees - - All Other Fees - - Total Fees $367,913 $708,455 (1)Audit Fees consist of fees billed for professional services performed by CohnReznick LLP for the audit of our consolidated annual financial statementsfor the years ended December 31, 2016 and 2015, the review of our quarterly financial statements on Form 10-Q, the review of the 2016 PIPEfinancing, filing of a Registration Statement on Forms S-3 and S-8, and associated Consent Letters and related services that are normally provided inconnection with statutory and regulatory filings or engagements.(2)2015 Audit Related Fees consist of fees billed by CohnReznick LLP in connection with our initial public offering, the filing of a RegistrationStatement on Form S-8 with respect to our equity plans, and our acquisition of AdvanDx, Inc.Our Audit Committee has a policy in place that requires its review and pre-approval of all audit and permissible non-audit services provided by ourindependent registered public accounting firm. The services requiring pre-approval by the audit committee may include audit services, audit-relatedservices, tax services and other services. All such audit and permissible non-audit services were pre-approved in accordance with this policy during the fiscalyear ended December 31, 2016. The Audit Committee considers whether the provision of each non-audit service is compatible with maintaining theindependence of our independent registered public accounting firm. The responsibility to pre-approve audit and non-audit services may be delegated by theAudit Committee to one or more members of the Audit Committee; provided that any decisions made by such member or members must be presented to thefull Audit Committee at its next scheduled meeting.73 PART IVItem 15. Exhibits and Financial Statement Schedules(a)(1) Financial Statements.The consolidated balance sheets of the Company as of December 31, 2016 and 2015, the related consolidated statements of operations andcomprehensive loss, stockholders’ equity (deficit) and cash flows for the years then ended, the related notes to the consolidated financial statements and thereport of CohnReznick LLP, independent registered public accounting firm, are filed herewith following the signature page.(a)(2) Financial Statement Schedules.Not applicable.(a)(3) Exhibits:A list of exhibits to this Annual Report is set forth on the Exhibit Index immediately preceding such exhibits and is incorporated herein by reference.(b) ExhibitsSee Exhibit Index.(c) Not applicable.Item 16. Form 10-K SummaryThe Company has chosen not to include a summary of this Form 10-K.74 SIGNATURESPursuant 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 onits behalf by the undersigned, thereunto duly authorized. OPGEN, INC. By:/s/ Evan Jones Evan Jones Chief Executive Officer Date: March 24, 2017 By:/s/ Timothy C. Dec Timothy C. Dec Chief Financial Officer Date: March 24, 2017 POWER OF ATTORNEYWe, the undersigned officers and directors of OpGen, Inc., hereby severally constitute and appoint Evan Jones and Timothy C. Dec, our true and lawfulattorney-in-fact and agent, with full power of substitution and resubstitution in her or him for her or him and in her or his name, place and stead, and in anyand all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto and other documents inconnection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do andperform each and every act and thing requisite or necessary to be done in and about the premises, as full to all intents and purposes as she or he might orcould do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or her or his substitute or substitutes, may lawfully do or cause tobe done by virtue hereof.Pursuant to the requirements the Securities Exchange Act of 1934, this Annual Report on Form 10-K has been signed below by the following persons onbehalf of the registrant and in the capacities and on the dates indicated. Signature Title Date /s/ Evan Jones Chief Executive Officer and Director March 24, 2017Evan Jones (principal executive officer) /s/ Timothy C. Dec Chief Financial Officer March 24, 2017Timothy C. Dec (principal financial officer and principal accounting officer) /s/ Brian G. Atwood Director March 24, 2017Brian G. Atwood /s/ Harry J. D’Andrea Director March 24, 2017Harry J. D’Andrea /s/ Timothy J.R. Harris Director March 24, 2017Timothy J.R. Harris /s/ Laurence R. McCarthy Director March 24, 2017Laurence R. McCarthy /s/ David M. Rubin Director March 24, 2017David M. Rubin /s/ Misti Ushio Director March 24, 2017Misti Ushio 75 OPGEN, INC.Index to Consolidated Financial Statements Report of Independent Registered Public Accounting FirmF-2 Consolidated Balance SheetsF-3 Consolidated Statements of Operations and Comprehensive LossF-4 Consolidated Statements of Stockholders’ Equity (Deficit)F-5 Consolidated Statements of Cash FlowsF-6 Notes to Consolidated Financial StatementsF-7 F-1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Board of Directors and StockholdersOpGen, Inc.We have audited the accompanying consolidated balance sheets of OpGen, Inc. as of December 31, 2016 and 2015, and the related consolidated statementsof operations and comprehensive loss, stockholders’ equity (deficit) and cash flows for the years then ended. OpGen, Inc.’s management is responsible forthese consolidated financial statements. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. TheCompany is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included considerationof internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose ofexpressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An auditalso includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements, assessing the accountingprinciples used and significant estimates made by management, as well as evaluating the overall consolidated financial statement presentation. We believethat our audits provide a reasonable basis for our opinion.In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of OpGen, Inc. as ofDecember 31, 2016 and 2015, and the results of their operations and their cash flows for the years then ended in conformity with accounting principlesgenerally accepted in the United Stated of America.The consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in the Note 1 to theconsolidated financial statements, the Company has incurred cumulative net losses since inception and will need additional capital to fund future operations.These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not includeany adjustments that might result from the outcome of this uncertainty./s/CohnReznick LLPVienna, VirginiaMarch 23, 2017F-2 OpGen, Inc.Consolidated Balance SheetsAs of December 31, 2016 2015 Assets Current assets Cash and cash equivalents $4,117,324 $7,814,220 Accounts receivable, net 542,420 678,646 Inventory, net 692,368 826,012 Prepaid expenses and other current assets 329,646 566,239 Total current assets 5,681,758 9,885,117 Property and equipment, net 800,723 1,074,710 Goodwill 600,814 637,528 Intangible assets, net 1,620,998 1,888,814 Other noncurrent assets 279,752 270,327 Total assets $8,984,045 $13,756,496 Liabilities and Stockholders’ Equity Current liabilities Accounts payable $2,232,563 $2,285,792 Accrued compensation and benefits 578,480 1,081,270 Accrued liabilities 1,215,283 920,286 Deferred revenue 37,397 50,925 Short-term notes payable 1,023,815 — Current maturities of long-term capital lease obligation 184,399 251,800 Total current liabilities 5,271,937 4,590,073 Deferred rent 398,084 352,985 Note payable — 993,750 Long-term capital lease obligation and other noncurrent liabilities 146,543 328,642 Total liabilities 5,816,564 6,265,450 Commitments (Note 10) Stockholders' equity Common stock, $0.01 par value; 200,000,000 shares authorized; 25,304,270 and 12,547,684 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively 253,042 125,477 Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at December 31, 2016 and December 31, 2015, respectively — — Additional paid-in capital 136,199,382 121,490,994 Accumulated other comprehensive income/(loss) 6,176 (1,059)Accumulated deficit (133,291,119) (114,124,366)Total stockholders’ equity 3,167,481 7,491,046 Total liabilities and stockholders’ equity $8,984,045 $13,756,496 See accompanying notes to consolidated financial statements.F-3 OpGen, Inc.Consolidated Statements of Operations and Comprehensive LossFor The Years Ended December 31, 2016 2015 Revenue Product sales $3,524,178 $2,701,142 Laboratory services 228,904 120,476 Collaboration revenue 272,603 336,102 Total revenue 4,025,685 3,157,720 Operating expenses Cost of products sold 1,658,571 1,179,771 Cost of services 631,333 367,802 Research and development 8,613,236 6,002,941 General and administrative 6,602,608 5,834,642 Sales and marketing 5,529,274 4,305,444 Transaction expenses — 526,283 Total operating expenses 23,035,022 18,216,883 Operating loss (19,009,337) (15,059,163)Other expense Interest and other (expense)/income (5,967) 26,657 Interest expense (143,347) (1,801,320)Foreign currency transaction losses (8,102) — Change in fair value of derivative financial instruments — (647,342)Total other expense (157,416) (2,422,005)Loss before income taxes (19,166,753) (17,481,168) Provision for income taxes — (129,095)Net loss (19,166,753) (17,352,073) Preferred stock dividends and beneficial conversion (332,550) (243,762)Net loss available to common stockholders $(19,499,303) $(17,595,835)Net loss per common share - basic and diluted $(1.10) $(2.20)Weighted average shares outstanding - basic and diluted 17,667,557 7,980,995 Net loss $(19,166,753) $(17,352,073)Other comprehensive income/(loss) - foreign currency translation 7,235 (1,059)Comprehensive loss $(19,159,518) $(17,353,132) See accompanying notes to consolidated financial statements. F-4 OpGen, Inc.Consolidated Statements of Stockholders’ Equity (Deficit) Common Stock Preferred Stock Additional AccumulatedOther Number ofShares Amount Number ofShares Amount Paid-in Capital Comprehensive(Loss) / Income AccumulatedDeficit Total Balances at December 31, 2014 493,178 $4,932 — — $88,701,737 $— $(96,772,293) $(8,065,624)Stock option exercises 11,472 114 — — 2,189 — — 2,303 Beneficial conversion feature — — — — 1,427,667 — — 1,427,667 Reclassification of warrant liabilityto equity — — — — 719,675 — — 719,675 Conversion of preferred stock intocommon shares 7,374,852 73,749 — — 7,730,423 — — 7,804,172 Demand notes tendered for IPOUnits 350,000 3,500 — — 2,096,500 — — 2,100,000 Issuance of IPO units, net ofoffering costs 2,500,000 25,000 — — 12,104,133 — — 12,129,133 Additional IPO issuance costs — — — — (58,566) — — (58,566)Common shares issued in businesscombination 681,818 6,818 — — 2,577,272 — — 2,584,090 Common shares issued infinancing 1,136,364 11,364 — — 4,988,638 — — 5,000,002 Stock compensation expense — — — — 1,445,088 — — 1,445,088 Accretion of Series A preferredstock — — — — (243,762) — — (243,762)Foreign currency translation — — — — — (1,059) — (1,059)Net loss — — — — — — (17,352,073) (17,352,073)Balances at December 31, 2015 12,547,684 $125,477 — — 121,490,994 (1,059) (114,124,366) 7,491,046 Stock option exercises 66,502 665 — — 23,106 — — 23,771 Private offering of common stock,preferred stock and warrants, net ofissuance costs 6,744,127 67,441 2,309,428 23,094 9,370,214 — — 9,460,749 Preferred stock conversion 2,309,428 23,094 (2,309,428) (23,094) — — — (0)At the market offering, net ofoffering costs 3,619,863 36,199 — — 4,369,774 — — 4,405,973 Issuance of RSUs 16,666 166 — — (167) — — (1)Stock compensation expense — — — — 945,461 — — 945,461 Foreign currency translation — — — — — 7,235 — 7,235 Net loss — — — — — — (19,166,753) (19,166,753)Balances at December 31, 2016 25,304,270 $253,042 — $- $136,199,382 $6,176 $(133,291,119) $3,167,481 See accompanying notes to consolidated financial statements. F-5 OpGen, Inc.Consolidated Statements of Cash FlowsYears Ended December 31, 2016 2015 Cash flows from operating activities Net loss $(19,166,753) $(17,352,073)Adjustments to reconcile net loss to net cash used in operating activities Depreciation and amortization 656,047 624,653 Loss on disposal of property and equipment 6,309 — Deferred tax benefit — (129,095)Noncash interest expense 4,527 1,598,312 Share-based compensation 945,461 1,445,088 Inventory obsolescence 113,465 — Change in fair value of derivative financial instruments — 647,342 Other non-cash items — 24,010 Changes in operating assets and liabilities, net of effects of acquisition: Accounts receivable 136,226 359,298 Inventory 20,179 424,505 Other assets 263,882 (319,305)Accounts payable (53,229) 196,444 Accrued compensation and other liabilities (163,223) (1,508,937)Deferred revenue (13,528) (288,246)Net cash used in operating activities (17,250,637) (14,278,004)Cash flows from investing activities Cash acquired in business combinations — 1,367,211 Purchases of property and equipment (net of proceeds on disposals) (123,514) (185,296)Net cash (used in)/provided by investing activities (123,514) 1,181,915 Cash flows from financing activities Proceeds from issuance of common stock, net of issuance costs 4,405,973 17,366,620 Proceeds from issuance of convertible notes and warrants, net of issuance costs — 1,388,815 Proceeds from issuance of promissory notes, net of issuance costs 204,895 1,741,667 Proceeds from exercise of stock options and warrants 23,771 2,293 Proceeds from private offering of common stock, preferred stock and warrants, net of issuance costs 9,460,749 — Payments on debt (178,997) (155,000)Payments on capital lease obligations (251,701) (175,317)Net cash provided by financing activities 13,664,690 20,169,078 Effects of exchange rates on cash 12,565 (8,286)Net (decrease)/increase in cash and cash equivalents (3,696,896) 7,064,703 Cash and cash equivalents at beginning of period 7,814,220 749,517 Cash and cash equivalents at end of period $4,117,324 $7,814,220 Supplemental disclosure of cash flow information Cash paid for interest $58,564 $194,288 Supplemental disclosures of noncash investing and financing activities: Acquisition of equipment purchased through capital leases $— $580,477 Common stock issued in business combination $— $2,584,090 Conversion of convertible promissory notes to Series A preferred stock $— $3,000,000 Conversion of series A preferred stock into common shares $— $8,183,661 Exchange of demand notes for IPO units $— $2,100,000 Exchange of demand note for convertible debt $— $300,000 See accompanying notes to consolidated financial statements.F-6 OpGen, Inc.Notes to Consolidated Financial StatementsNote 1 – OrganizationOpGen, Inc. (“OpGen” of the “Company”) was incorporated in Delaware in 2001. On July 14, 2015, OpGen completed the strategic acquisition (the“Merger”) of AdvanDx, Inc. and its wholly owned subsidiary AdvanDx A/S (collectively, “AdvanDx”) (see Note 4). Pursuant to the terms of a mergeragreement, Velox Acquisition Corp., OpGen’s wholly owned subsidiary formed for the express purpose of effecting the Merger, merged with and intoAdvanDx, Inc. with AdvanDx, Inc. surviving as OpGen’s wholly owned subsidiary. OpGen, AdvanDx, Inc. and AdvanDx A/S are collectively referred tohereinafter as the “Company.” The Company’s headquarters are in Gaithersburg, Maryland, and its principal operations are in Gaithersburg, Maryland andWoburn, Massachusetts. The Company also has operations in Copenhagen, Denmark. The Company operates in one business segment.OpGen is a precision medicine company using molecular diagnostics and bioinformatics to help combat infectious disease. The Company is developingmolecular information products and services to combat infectious disease in global healthcare settings, helping to guide clinicians with more rapidinformation about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms.Its proprietary DNA tests and bioinformatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimizepatient care decisions and protect the hospital biome through customized screening and surveillance products and services.The Company’s molecular diagnostics and bioinformatics offerings combine its Acuitas DNA tests, Acuitas Lighthouse bioinformatics services, and CLIA labservices for MDRO surveillance. The Company is working to deliver its products and services, some in development, to a global network of customers andpartners. These include: •Its Acuitas DNA tests, which provide rapid microbial identification, and antibiotic resistance gene information. These products include theQuickFISH family of FDA-cleared and CE-marked diagnostics used to rapidly detect pathogens in positive blood cultures, the Acuitas MDROGene Test to detect, type, track, and trend antibiotic resistant organisms in real-time and the Acuitas Rapid Test in development. The Companyis working to provide actionable, precise diagnostic information powered by pathogen surveillance data collected through hospital screeningprograms and a network of hospital and public health laboratories globally. •Its Acuitas Lighthouse bioinformatics systems, which are cloud-based HIPAA compliant bioinformatics offerings that combine clinical lab testresults with patient and hospital information and provide analytics to help manage MDROs in the hospital and patient care environment. Theseinclude its Acuitas Lighthouse informatics, which can be specific to a healthcare facility, public health department or collaborator, such as apharmaceutical company, and its Acuitas Lighthouse Knowledgebase, a proprietary data warehouse in development to include genomic datamatched with antibiotic susceptibility information for microbes and patient information from healthcare providers, in which the Company isbeginning to collect and store MDRO information from a variety of sources for use with its Acuitas Rapid Test in development. The Company’s operations are subject to certain risks and uncertainties. The risks include rapid technology changes, the need to manage growth, the need toretain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. TheCompany’s success depends, in part, on its ability to develop and commercialize its proprietary technology as well as raise additional capital.Note 2 - Going Concern and Management’s PlansThe accompanying consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets andsatisfaction of liabilities in the normal course of business. Since inception, the Company has incurred, and continues to incur, significant losses fromoperations. The Company has funded its operations primarily through external investor financing arrangements and has raised significant funds in 2016 and2015, including:On September 13, 2016, the Company entered into the Sales Agreement with Cowen pursuant to which the Company may offer and sell from time to time, upto an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. Pursuant to the Sales Agreement, Cowen may sell the shares of common stock by any method permitted by law deemed to be an “at the market” offering asdefined in Rule 415 of the Securities Act, including, without limitation, sales made by means of ordinary brokers’ transactions on The NASDAQ CapitalMarket or otherwise at market prices prevailing at the time of sale, in block transactions, or as otherwise directed by the Company. The Company pays Cowencompensation equal to 3.0% of the gross proceeds from the sales of common stock pursuant to the terms of the Sales Agreement. As of December 31, 2016,the Company has sold an aggregate of approximately 3.6 million shares of its common stock under this at theF-7 market offering resulting in aggregate net proceeds to the Company of approximately $4.4 million, and gross proceeds of $4.7 million. As of December 31,2016, under the initial sales agreement, remaining availability under the at the market offering is $6.8 million. Subsequent to December 31, 2016, theCompany has sold an aggregate of approximately 2.1 million shares of its common stock under this at the market offering resulting in aggregate net proceedsto the Company of approximately $2.1 million, and gross proceeds of $2.2 million. Under the initial sales agreement, remaining availability under the at themarket offering is $4.6 million.In May and June 2016, the Company offered and sold units in a private offering to members of management and employees and to accredited investors,including Merck GHI and jVen Capital, each unit consisting of either (i) one share of common stock and a detachable stock purchase warrant to purchase anadditional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant to purchase anadditional 0.75 shares of common stock, at a price of $1.14 per unit. The total net proceeds to the Company, after deducting offering commissions andexpenses was $9.5 million. Pursuant to the private placement, the Company issued 6,744,127 shares of common stock, 2,309,428 of non-voting convertiblepreferred stock and stock purchase warrants to acquire an additional 6,790,169 shares of common stock.In July 2015, the Company raised $6.0 million by issuing 1,136,364 shares of common stock at $4.40 per share and a $1.0 million senior secured promissorynote to Merck GHI. Under the Purchase Agreement, Merck GHI has the right to participate in future securities offerings made by the Company (see Note 5).In May 2015, OpGen completed its IPO for total gross proceeds of $17.1 million (see Note 8).To meet its capital needs, the Company is considering multiple alternatives, including, but not limited to, additional equity financings, debt financings andother funding transactions, licensing and/or partnering arrangements and business combination transactions. There can be no assurance that the Companywill be able to complete any such transaction on acceptable terms or otherwise. The Company believes that current cash on hand will be sufficient to fundoperations into the second quarter of 2017. This has led management to conclude that substantial doubt about the Company’s ability to continue as a goingconcern exists. In the event the Company is unable to successfully raise additional capital during or before the second quarter of 2017, the Company will nothave sufficient cash flows and liquidity to finance its business operations as currently contemplated. Accordingly, in such circumstances the Company wouldbe compelled to immediately reduce general and administrative expenses and delay research and development projects, including the purchase of scientificequipment and supplies, until it is able to obtain sufficient financing. If such sufficient financing is not received timely, the Company would then need topursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. Furthermore, the $1.0million senior secured promissory note matures in July 2017. If the company is unable to repay the note, negotiate its conversion or extend its term, theassets of the company may be seized, as the note is secured by a lien on all the company’s assets. Note 3 - Summary of Significant Accounting PoliciesBasis of PresentationThe accompanying consolidated financial statements are prepared in accordance with generally accepted accounting standards in the United States (“U.S.GAAP”). The consolidated financial statements consolidate the operations of all controlled subsidiaries; all intercompany activity is eliminated. Certain priorperiod information has been reclassified to conform to the current period presentation.Foreign CurrencyAdvanDx A/S is located in Copenhagen, Denmark and uses the Danish Kroner as its functional currency. As a result, all assets and liabilities are translatedinto U.S. dollars based on exchange rates at the end of the reporting period. Income and expense items are translated at the average exchange rates prevailingduring the reporting period. Translation adjustments are reported in accumulated other comprehensive income/(loss), a component of stockholders’ equity.Foreign currency translation adjustments are the sole component of accumulated other comprehensive loss at December 31, 2016 and 2015.Foreign currency transaction gains and losses, excluding gains and losses on intercompany balances where there is no current intent to settle such amounts inthe foreseeable future, are included in the determination of net loss. Unless otherwise noted, all references to “$” or “dollar” refer to the United States dollar.Use of EstimatesIn preparing financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts ofassets and liabilities and the disclosure of contingent assets and liabilities at the date of the financialF-8 statements and the reported amounts of revenues and expenses during the reporting period. In the accompanying consolidated financial statements, estimatesare used for, but not limited to, share-based compensation, allowances for doubtful accounts and inventory obsolescence, valuation of derivative financialinstruments, beneficial conversion features of convertible debt, deferred tax assets and liabilities and related valuation allowance, and depreciation andamortization and estimated useful lives of long-lived assets. Actual results could differ from those estimates.Fair value of financial instrumentsAll financial instruments classified as current assets and liabilities are carried at cost, which approximates fair value, because of the short-term maturities ofthose instruments.For additional fair value disclosures, see Note 13.Cash and cash equivalents and restricted cashThe Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. The Company has cash and cashequivalents deposited in financial institutions in which the balances occasionally exceed the federal government agency (FDIC) insured limits of $250,000.The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk.As of December 31, 2016 and 2015, the Company has funds totaling $243,380, which are required as collateral for letters of credit benefiting its landlordsand for credit card processors. These funds are reflected in other noncurrent assets on the accompanying consolidated balance sheets.Accounts ReceivableThe Company’s accounts receivable result from revenues earned but not collected from customers. Credit is extended based on an evaluation of a customer’sfinancial condition and, generally, collateral is not required. Accounts receivable are due within 30 to 60 days and are stated at amounts due from customers.The Company evaluates if an allowance is necessary by considering a number of factors, including the length of time accounts receivable are past due, theCompany’s previous loss history and the customer’s current ability to pay its obligation. If amounts become uncollectible, they are charged to operationswhen that determination is made. The allowance for doubtful accounts was $26,716 and $15,596 as of December 31, 2016 and 2015, respectively.At December 31, 2016, the Company had accounts receivable from one customer, a related party, which individually represented 25% of total accountsreceivable. At December 31, 2015, the Company had accounts receivable from one customer which individually represent 25% of total accounts receivable.No individual customer represented in excess of 10% of revenues for year ended December 31, 2016. For the year ended December 31, 2015, revenue earnedfrom Hitachi High-Technologies Corporation (“Hitachi”) represented 11% of total revenues.InventoryInventories are valued using the first-in, first-out method and stated at the lower of cost or market and consist of the following: December 31,2016 December 31,2015 Raw materials and supplies $479,479 $362,526 Work-in process 27,422 150,369 Finished goods 185,467 313,117 Total $692,368 $826,012 Inventory includes reagents and components for QuickFISH and PNA FISH kit products, Argus Whole Genome Mapping Systems, reagents and supplies usedfor Argus consumable kits, and reagents and supplies used for the Company’s laboratory services. Inventory reserves for obsolescence and expirations were$704,516 and $591,051 at December 31, 2016 and 2015, respectively.F-9 Long-lived assetsProperty and equipmentProperty and equipment is stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets. The estimated servicelives approximate three to five years. Depreciation expense was $388,231 and $500,467 for the years ended December 31, 2016 and 2015, respectively.Property and equipment consisted of the following at December 31, 2016 and 2015: December 31, 2016 2015 Laboratory and manufacturing equipment $3,785,133 $3,734,044 Office furniture and equipment 688,952 701,557 Computers and network equipment 1,472,144 1,563,177 Leasehold improvements 662,506 659,949 6,608,735 6,658,727 Less accumulated depreciation (5,808,012) (5,584,017)Property and equipment, net $800,723 $1,074,710 In 2012, the Company began to provide Argus™ Whole Genome Systems under its Argus Reagent Rental Program to customers, in which the Companyretains title without requiring customers to purchase the equipment or enter into an equipment lease or rental contract. The costs associated with theseinstruments are capitalized and charged to sales and marketing on a straight-line basis over the estimated useful life of the instrument, which is approximatelyfour years. During the years ended December 31, 2016 and 2015, sales and marketing expenses related to these costs were $0 and approximately $175,000,respectively. The costs to maintain these systems are charged to operations as incurred.Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not berecoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cashflows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level forwhich we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assetsexceeds the fair value of the assets. During the years ended December 31, 2016 and 2015, the Company determined that its property and equipment was notimpaired.Intangible assets and goodwillIntangible assets and goodwill as of December 31, 2016 were acquired as part of the Merger, and consist of finite-lived intangible assets and goodwill.Finite-lived intangible assetsFinite-lived intangible assets include trademarks, developed technology and customer relationships, and consisted of the following as of December 31, 2016and 2015: December 31, 2016 December 31, 2015 Cost AccumulatedAmortization Net Balance AccumulatedAmortization Net Balance Trademarks and tradenames $461,000 $(67,575) $393,425 $(21,471) $439,529 Developed technology 458,000 (95,898) 362,102 (30,474) 427,526 Customer relationships 1,094,000 (228,529) 865,471 (72,241) 1,021,759 $2,013,000 $(392,002) $1,620,998 $(124,186) $1,888,814 Finite-lived intangible assets are amortized over their estimated useful lives. The estimated useful life of trademarks was 10 years, developed technology was7 years, and customer relationships was 7 years. The Company reviews the useful lives of intangible assets when events or changes in circumstances occurwhich may potentially impact the estimated useful life of the intangible assets. Total amortization expense of intangible assets was $267,816 and $124,186 for the years ended December 31, 2016 and 2015, respectively. Amortization ofintangible assets is expected to be approximately $268,000 per year for the next five years.F-10 Finite-lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset maynot be recoverable. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the netundiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is notrecoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. During yearsended December 31, 2016 and 2015, the Company determined that its finite-lived intangible assets were not impaired. In accordance with ASC 360-10, the Company records impairment losses on long-lived assets used in operations when events and circumstances indicate thatlong-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of thoseassets. During the fourth quarter of 2016, events and circumstances indicated the Company’s intangible assets might be impaired. However, management’sestimate of undiscounted cash flows indicated that such carrying amounts were expected to be recovered. Nonetheless, it is reasonably possible that theestimate of undiscounted cash flows may change in the near term resulting in the need to write down those assets to fair value. Management’s estimate of cashflows might change if the development of the Company’s automated rapid pathogen identification product technological advances does not progress asplanned, the timeline of development is delayed, there are changes to the estimates of the future marketability of this product or if the Company cannotobtain sufficient funding to pay for its development. GoodwillGoodwill represents the excess of the purchase price for AdvanDx over the fair values of the acquired tangible or intangible assets and assumed liabilities.Goodwill is not tax deductible in any relevant jurisdictions.The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year, and will also conduct tests if events occur orcircumstances change that would, more likely than not, reduce the Company’s fair value below its net equity value. As of December 31, 2016, the Companydetermined that its goodwill was not impaired.Deferred rentDeferred rent is recorded and amortized to the extent the total minimum rental payments allocated to the current period on a straight-line basis exceed or areless than the cash payments required.Revenue recognitionThe Company recognizes revenue primarily from sales of its products and services when the following criteria are met: persuasive evidence of an arrangementexists; delivery has occurred; the selling price is fixed or determinable; and collectability is reasonably assured. At times, the Company sells products andservices, or performs software development, under multiple-element arrangements with separate units of accounting; in these situations, total consideration isallocated to the identified units of accounting based on their relative fair value and revenue is then recognized for each unit based on its specificcharacteristics.Amounts billed to customers for shipping and handling are included in revenue when the related product or service revenue is recognized. Shipping andhandling costs are included in cost of products sold.Revenue from sales of QuickFISH, PNA FISH and XpressFISH diagnostic test productsRevenue is recognized upon shipment to the customer.Revenue from providing laboratory servicesThe Company recognizes revenue associated with laboratory services contracts when the service has been performed and reports are made available to thecustomer.Revenue from funded software development arrangementsThe Company’s funded software development arrangements generally consist of multiple elements. Total arrangement consideration is allocated to theidentified units of accounting based on their relative selling prices and revenue is then recognized for each unit based on its specific characteristics. Whenfunded software development arrangements include substantive research and development milestones, revenue is recognized for each such milestone whenthe milestone is achieved and is due and collectible. Milestones are considered substantive if all of the following conditions are met: (1) the milestone isnonrefundable; (2) achievement of the milestoneF-11 was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of themilestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with achievement ofthe milestone.Revenue from license arrangementsThe Company recognizes revenue from licenses of its technologies over the applicable license term.Revenue from sales of the Argus SystemWhen an Argus System is sold without the Genome Builder software, total arrangement consideration is recognized as revenue when the system is deliveredto the customer. Ancillary performance obligations, including installation, limited customer training and limited consumables, are consideredinconsequential and are combined with the Argus System as one unit of accounting.When an Argus System is sold with the Genome Builder software in a multiple-element arrangement, total arrangement consideration is allocated to theArgus System and to the Genome Builder software based on their relative selling prices. Selling prices are determined based on sales of similar systems tosimilar customers and, where no sales have occurred, on management’s best estimate of the expected selling price relative to similar products. Revenuerelated to the Argus System is recognized when it is delivered to the customer; revenue for the Genome Builder software is recognized when it is delivered tothe customer.Revenue from sales of Genome Builder Software and consumables (on a stand-alone basis)Revenue is recognized for Genome Builder Software and for consumables, when sold on a standalone basis, upon delivery to the customer.Revenue from extended warranty service contractsThe Company recognizes revenue associated with extended warranty service contracts over the service period in proportion to the costs expected to beincurred over that same period.Research and development costsResearch and development costs are expensed as incurred. Research and development costs primarily consist of salaries and related expenses for personnel,other resources, laboratory supplies, fees paid to consultants and outside service partners.Share-based compensationShare-based compensation expense is recognized at fair value. The fair value of share-based compensation to employees and directors is estimated, on thedate of grant, using the Black-Scholes model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vestingperiod of the option. For all time-vesting awards granted, expense is amortized using the straight-line attribution method. The Company accounts forforfeitures as they occur.Option valuation models, including the Black-Scholes model, require the input of highly subjective assumptions, and changes in the assumptions used canmaterially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatilityand the expected life of the award. A discussion of management’s methodology for developing each of the assumptions used in the Black-Scholes model is asfollows:Fair value of common stockFor periods prior to the Company’s IPO, given the lack of an active public market for the common stock, the Company’s board of directors determined the fairvalue of the common stock. In the absence of a public market, and as an emerging company with no significant revenues, the Company believed that it wasappropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. The factors included: (1) the achievementof clinical and operational milestones by the Company; (2) the status of strategic relationships with collaborators; (3) the significant risks associated with theCompany’s stage of development; (4) capital market conditions for life science and medical diagnostic companies, particularly similarly situated, privatelyheld, early stage companies; (5) the Company’s available cash, financial condition and results of operations; (6) the most recent sales of the Company’spreferred stock; and (7) the preferential rights of the outstanding preferred stock. Since the IPO, the Company uses the quoted market price of its commonstock as its fair value.F-12 Expected volatilityVolatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate(expected volatility) during a period. Until a significant trading history for its common stock develops, the Company has identified several public entities ofsimilar size, complexity and stage of development; accordingly, historical volatility has been calculated using the volatility of this peer group.Expected dividend yieldThe Company has never declared or paid dividends on its common stock and has no plans to do so in the foreseeable future.Risk-free interest rateThis is the U.S. Treasury rate for the day of each option grant during the year, having a term that most closely resembles the expected term of the option.Expected termThis is the period of time that the options granted are expected to remain unexercised. Options granted have a maximum term of 10 years. The Companyestimates the expected term of the option to be 6.25 years for options with a standard four-year vesting period, using the simplified method. Over time,management will track actual terms of the options and adjust their estimate accordingly so that estimates will approximate actual behavior for similaroptions.Income taxesIncome taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the expected future taxconsequences attributable to temporary differences between financial statement carrying amounts of existing assets and liabilities and their respective taxbasis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporarydifferences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in theperiod that includes the enactment date. A valuation allowance is established when necessary to reduce deferred income tax assets to the amount expected tobe realized.Tax benefits are initially recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the taxauthorities. Such tax positions are initially, and subsequently, measured as the largest amount of tax benefit that is greater than 50% likely of being realizedupon ultimate settlement with the tax authority, assuming full knowledge of the position and all relevant facts.The Company had federal net operating loss (“NOL”) carryforwards of $150,950,436 and $132,359,334 at December 31, 2016 and 2015, respectively.Despite the NOL carryforwards, which begin to expire in 2022, the Company may have future tax liability due to alternative minimum tax or state taxrequirements. Also, use of the NOL carryforwards may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code of 1986, asamended (the “Code”). To date, the Company has not performed a formal study to determine if any of its remaining NOL and credit attributes might be furtherlimited due to the ownership change rules of Section 382 or Section 383 of the Code. The Company will continue to monitor this matter going forward. Therecan be no assurance that the NOL carryforwards will ever be fully utilized.Loss per shareBasic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stockoutstanding during the period.For periods of net income, and when the effects are not anti-dilutive, diluted earnings per share is computed by dividing net income available to commonstockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of commonstock options and stock purchase warrants using the treasury stock method, and convertible preferred stock and convertible debt using the if-convertedmethod.For periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all dilutive potential common shares is anti-dilutive. The number of anti-dilutive shares, consisting of (i) common stock options, (ii) stock purchase warrants, and (iii) restricted stock units representingthe right to acquire shares of common stock which have been excluded from the computation of diluted loss per share, was 13.5 million shares and 6.0million shares as of December 31, 2016 and 2015, respectively.F-13 The Company’s convertible preferred stock, prior to its conversion, contained non-forfeitable rights to dividends, and therefore was considered to be aparticipating security; the calculation of basic and diluted income (loss) per share excludes net income (but not net loss) attributable to the convertiblepreferred stock from the numerator and excludes the impact of those shares from the denominator in periods prior to the IPO.Recent accounting pronouncementsIn May 2014, the Financial Accounting Standards Board (“FASB”) issued guidance for revenue recognition for contracts, superseding the previous revenuerecognition requirements, along with most existing industry-specific guidance. The guidance requires an entity to review contracts in five steps: 1) identifythe contract, 2) identify performance obligations, 3) determine the transaction price, 4) allocate the transaction price, and 5) recognize revenue. The newstandard will result in enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenue arising from contracts with customers. In August2015, the FASB issued guidance approving a one-year deferral, making the standard effective for reporting periods beginning after December 15, 2017, withearly adoption permitted only for reporting periods beginning after December 15, 2016. In March 2016, the FASB issued guidance to clarify theimplementation guidance on principal versus agent considerations for reporting revenue gross rather than net, with the same deferred effective date. In April2016, the FASB issued guidance to clarify the identification of performance obligations and licensing arrangements. In May 2016, the FASB issued guidanceaddressing the presentation of sales and other similar taxes collected from customers, providing clarification of the collectability criterion assessment, as wellas clarifying certain transition requirements. The Company is currently evaluating the impact, if any, that this guidance will have on its consolidatedfinancial statements.In August 2014, the FASB issued guidance requiring management to evaluate on a regular basis whether any conditions or events have arisen that could raisesubstantial doubt about the entity’s ability to continue as a going concern. The guidance 1) provides a definition for the term “substantial doubt,” 2) requiresan evaluation every reporting period, interim periods included, 3) provides principles for considering the mitigating effect of management’s plans to alleviatethe substantial doubt, 4) requires certain disclosures if the substantial doubt is alleviated as a result of management’s plans, 5) requires an express statement,as well as other disclosures, if the substantial doubt is not alleviated, and 6) requires an assessment period of one year from the date the financial statementsare issued. This guidance is effective for the annual periods ending after December 15, 2016 and for annual and interim reporting periods thereafter. TheCompany has made the appropriate disclosures required by this guidance. The adoption of this guidance has had no financial statement impact.In April 2015, the FASB issued accounting guidance requiring that debt issuance costs related to a recognized liability be presented on the balance sheet as adirect reduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuancecosts are not affected. The standard is effective for reporting periods beginning after December 15, 2015. The Company adopted this guidance effectiveJanuary 1, 2016 on a retrospective basis, and all periods are presented under this guidance.In April 2015, the FASB issued guidance as to whether a cloud computing arrangement (e.g., software as a service, platform as a service, infrastructure as aservice, and other similar hosting arrangements) includes a software license and, based on that determination, how to account for such arrangements. If acloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistentwith the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for thearrangement as a service contract. The guidance is effective for reporting periods beginning after December 15, 2015, and can be adopted on either aprospective or retrospective basis. The Company adopted this guidance for the year ended December 31, 2016, on a prospective basis. The adoption of thisnew guidance did not have a material impact on the Company’s consolidated financial statements.In July 2015, the FASB issued accounting guidance for inventory. Under the guidance, an entity should measure inventory within the scope of this guidanceat the lower of cost and net realizable value, except when inventory is measured using LIFO or the retail inventory method. Net realizable value is theestimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. In addition, the FASBhas amended some of the other inventory guidance to more clearly articulate the requirements for the measurement and disclosure of inventory. The standardis effective for reporting periods beginning after December 15, 2016. The amendments in this pronouncement should be applied prospectively, with earlierapplication permitted. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidatedfinancial statements.In February 2016, the FASB issued guidance for the accounting for leases. The guidance requires lessees to recognize assets and liabilities related to long-term leases on the consolidated balance sheets and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reportingperiods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides forcertain practical expedients. The Company is currently evaluating the impact, if any, that this new accounting pronouncement will have on its consolidatedfinancial statements.F-14 In March 2016, the FASB issued guidance simplifying the accounting for and financial statement disclosure of stock-based compensation awards. Under theguidance, all excess tax benefits and tax deficiencies related to stock-based compensation awards are to be recognized as income tax expenses or benefits inthe income statement and excess tax benefits should be classified along with other income tax cash flows in the operating activities section of the statementof cash flows. Under the guidance, companies can also elect to either estimate the number of awards that are expected to vest or account for forfeitures as theyoccur. In addition, the guidance amends some of the other stock-based compensation awards guidance to more clearly articulate the requirements and cashflow presentation for withholding shares for tax-withholding purposes. The guidance is effective for reporting periods beginning after December 15, 2016and early adoption is permitted, though all amendments of the guidance must be adopted in the same period. The Company elected to adopt the guidanceeffective for the fiscal year ended December 31, 2016 and apply it retrospectively for all periods presented. This has not materially impacted the Company'sconsolidated results of operations, financial position or cash flows.The Company has evaluated all other issued and unadopted Accounting Standards Updates and believes the adoption of these standards will not have amaterial impact on its results of operations, financial position, or cash flows.Note 4 – Business CombinationOn July 14, 2015, the Company acquired 100% of the capital stock of AdvanDx in the Merger in a taxable transaction. AdvanDx researches, develops andmarkets advanced IVD kits for the diagnosis and prevention of infectious diseases, and sells its products principally to hospitals and clinical laboratories inthe United States and Europe. The Company acquired AdvanDx principally to use AdvanDx’s diagnostic capabilities with respect to MDROs and leverageAdvanDx’s relationships with hospitals and clinical laboratories to accelerate the sales of OpGen’s products and services.Pursuant to an Agreement and Plan of Merger (the “Merger Agreement”), Velox Acquisition Corp. merged with and into AdvanDx, Inc. with AdvanDx, Inc.surviving as a wholly owned subsidiary of the Company in accordance with the General Corporation Law of the State of Delaware. Under the terms of theMerger Agreement, the merger consideration consisted of an aggregate 681,818 shares of the Company’s common stock with a value of $2.6 million (the“Merger Consideration”), which Merger Consideration was distributed in accordance with the liquidation preferences set forth in the AdvanDx, Inc. RestatedCertificate of Incorporation, as amended.The Company accounted for its acquisition of AdvanDx by recording all tangible and intangible assets acquired and liabilities assumed at their estimated fairvalues on the acquisition date, with the remaining unallocated purchase price recorded as goodwill. The fair value assigned to identifiable intangible assetsacquired was determined using an income approach for trade names and customer relationships, and a cost approach for technology. The Company receivedcarryover tax basis in the acquired assets and liabilities and no tax basis in the intangible assets (including goodwill) established on the acquisition date. As aresult, the Company recognized deferred tax assets related to foreign taxing jurisdictions of $4.3 million (fully offset by a corresponding valuationallowance) and net deferred tax liabilities of $0.1 million in the U.S. taxing jurisdiction. The net deferred tax liability in the U.S. taxing jurisdiction resultedin an income tax benefit related to a reduction in the Company’s previously established valuation allowance (which reduction is accounted for outside ofpurchase accounting). The following represents the allocation of the purchase price (as adjusted for measurement period adjustments): Total purchase price - fair value of common stock issued $2,584,090 Fair value of tangible assets acquired: Cash $1,367,211 Receivables 536,406 Inventory 881,273 Property and equipment 245,479 Other assets 359,587 Fair value of identifiable intangible assets acquired: Customer relationships 1,094,000 Developed technology 458,000 Trademarks and tradenames 461,000 Fair value of goodwill 600,814 Deferred tax liabilities, net 129,095 Fair value of liabilities assumed 3,290,585 $2,584,090 F-15 The total consideration paid in the acquisition exceeded the estimated fair value of the tangible and identifiable intangible assets acquired and liabilitiesassumed, resulting in approximately $0.6 million of goodwill. Goodwill, primarily related to expected synergies gained from combining operations, salesgrowth from future product offerings and customers, together with certain intangible assets that do not qualify for separate recognition, including assembledworkforce, is not tax deductible.Adjustments to goodwillIn the fourth quarter of 2015, the Company adopted new accounting guidance with respect to the accounting for measurement period adjustments resultingfrom business combinations. Under the new guidance, the Company is required to recognize adjustments to provisional amounts identified during themeasurement period in the reporting period in which the adjustments are determined and disclose the portion of the amount recorded in current-period lossesby line item that would have been recorded in previous reporting periods if the adjustment had been recognized as of the acquisition date.During the fourth quarter of 2015, as a result of obtaining new information about facts and circumstances that existed as of the acquisition date, the Companyadjusted the provisional estimated fair values of certain acquired assets and liabilities acquired in the Merger, resulting in an increase in goodwill recognizedof $345,781. During the first quarter of 2016, the Company identified an additional adjustment to the provisional estimated fair values, resulting in adecrease in goodwill recognized of $36,714.Pro Forma Disclosures (unaudited)The following unaudited pro forma financial information summarizes the results of operations for the year ended December 31, 2015 as if the Merger hadbeen completed as of January 1, 2015. Pro forma information primarily reflects adjustments relating to (i) elimination of the interest on AdvanDx’soutstanding debt, and (ii) the amortization of intangibles acquired. The pro forma amounts do not purport to be indicative of the results that would haveactually been obtained if the acquisition occurred as of January 1, 2014 or that may be obtained in the future: December 31,Unaudited pro forma results 2015Revenues $5,231,844Net loss $(20,751,552)Net loss per share $(2.52) Note 5 – Merck GHI FinancingOn July 14, 2015, as a condition of the Merger, the Company entered into the Purchase Agreement with Merck GHI, pursuant to which Merck GHI purchased1,136,364 shares of common stock of the Company at $4.40 per share for gross proceeds of $5.0 million. Pursuant to the Purchase Agreement, the Companyalso issued to Merck GHI a 8% Senior Secured Promissory Note (the “Merck Note”) in the principal amount of $1.0 million with a two-year maturity datefrom the date of issuance. The Company’s obligations under the Merck Note are secured by a lien on all of the Company’s assets. Under the PurchaseAgreement, Merck GHI has the right to participate in future securities offerings made by the Company. Also in July 2015, the Company entered into aRegistration Rights Agreement with Merck GHI and the AdvanDx stockholders who received shares of the Company’s common stock in the Merger, whichwill require the Company to register for resale by such holders in the future, such shares of Company common stock that cannot be sold under an exemptionfrom such registration.The Company incurred issuance costs of approximately $50,000 related to the financing. Approximately $8,000 of the issuance costs were deferred as debtissuance costs and netted against notes payable in the accompanying consolidated balance sheets as a result of the Company’s adoption of the newaccounting guidance in 2016 (see Note 3), and are being amortized as interest expense over the life of the Merck Note. The remaining $42,000 of issuancecosts were charged to additional paid-in capital.Note 6 - Redeemable Convertible Preferred StockAll shares of Series A Preferred Stock (including those shares issued in connection with the conversion of the 2014 and 2015 convertible debt) wereconverted into 7,374,852 shares of common stock in connection with the Company’s IPO (see Notes 7 and 8). Before such conversion, the Series A PreferredStock was redeemable at the option of the holders of 70% of the outstanding shares of Series A Preferred Stock, subject to certain additional requirements.The Company’s redeemable convertible preferred stock was classified as temporary equity due to redemption provisions outside of the Company’s control.F-16 The Company issued 1,999,864 shares of Series A Preferred Stock in December 2013 at $1.00 per share in exchange for $1,999,864 in convertible promissorynotes. In February 2014, the Company sold 1,405,096 shares of Series A redeemable convertible preferred stock for gross proceeds of $1,405,096. In April2014, the Company sold an additional 594,904 shares of Series A Preferred Stock for gross proceeds of $594,904. The Company incurred issuance costs of$62,098 related to the 2014 Series A Preferred Stock sales.The following table presents the changes in the Series A Preferred Stock during 2015: Shares Amount Balance at December 31, 2014 3,999,864 $4,564,899 2015 Accretion — 243,762 2015 Conversions (3,999,864) (4,808,661)Balance at December 31, 2015 — $— The Series A Preferred Stock had the right to receive non-cumulative dividends, at a rate of 8% per annum, when and if declared by the board of directors. TheSeries A Preferred Stock had preference of payment over all other classes and series of capital stock of the Company with respect to dividends, payment onliquidation and payment on redemption. The liquidation and redemption preferences were at two times the Series A Preferred Stock purchase price. The SeriesA preferred stockholders were entitled to vote on all matters that come to stockholders on an as-converted basis with holders of the common stock. Inaddition, the Series A Preferred Stock had broad based anti-dilution rights.The holders of Series A Preferred Stock had the right to convert such shares, at their option and at any time, into shares of common stock at the then-applicable conversion rate, as defined. The initial conversion rate was one common share for each preferred share, which may be adjusted for specifieddilutive transactions. Beginning in December 2019, the Company may have been obligated to redeem shares of Series A Preferred Stock, if requested, byholders of at least 70% of the then-outstanding shares of preferred stock. The redemption, if requested, would have taken place in three equal annualinstallments. Series A Preferred Stock would have been redeemed at two times the original issue price per share plus all accrued and unpaid dividends. Theredemptions were subject to certain equity adjustments for specified anti-dilution transactions, as defined.Note 7 – DebtAs of December 31, 2016, the Company’s outstanding debt consisted of the $1.0 million Merck Note that is due in July 2017 (see Note 5). As ofDecember 31, 2015, debt outstanding consisted of the $1.0 million Merck Note.Demand notesIn the fourth quarter of 2014 and first quarter of 2015, the Company raised a total of $2.3 million through the issuance of short-term demand notes. In the firstquarter of 2015, $0.3 million of demand notes, held by an entity controlled by our chief executive officer, were settled as partial payment for a 2015convertible note. All then-outstanding demand notes were tendered as payment for 350,000 units in the Company’s IPO (see Note 8). Prior to settlement, thedemand notes bore interest at 8% per annum, had a first priority security interest in the assets of the Company, and a term of approximately four months.2014 convertible debtIn July, August and September 2014, the Company raised $1.5 million through the issuance of convertible debt. All outstanding 2014 convertible debt wasconverted into Series A redeemable convertible preferred stock and then into 1,500,000 shares of common stock in connection with the Company’s IPO (seeNote 8). Prior to its conversion, the debt was convertible, at the option of the holders or in certain cases at the Company’s option, into shares of Series Aredeemable convertible preferred stock or other potential equity securities, bore interest at 8% and was due in full on July 11, 2015.2015 convertible debtIn February and March 2015, the Company raised $1.5 million in capital through the issuance of 8% secured convertible notes with detachable stockpurchase warrants. All outstanding 2015 convertible debt was converted into Series A redeemable convertible preferred stock and then into 1,875,000 sharesof common stock in connection with the Company’s IPO (see Note 8). Prior to its conversion, the 2015 convertible notes were prepayable by the Companywithout penalty at any time following the three-month anniversary of the closing of the IPO (provided that before the six-month anniversary of the closing ofan IPO, the 2015 convertible notes could only be prepaid out of newly issued capital subsequent to the IPO), and were puttable by the holder to the Companyin the event of a defined default. The 2015 convertible notes were each convertible, at the election of the holder, into (i) shares of Series AF-17 redeemable convertible preferred stock, at a conversion rate of 1.25 shares of Series A redeemable convertible preferred stock for each $1.00 converted if theconversion occurs prior to closing of an IPO, or (ii) shares of common stock at a conversion rate of one share of common stock for each $1.00 converted if theconversion occurs after the closing of an IPO.The conversion option embedded in the convertible notes was determined to contain beneficial conversion features, resulting in the bifurcation of thosefeatures as an equity instrument (resulting in an additional debt discount) at issuance. After allocation of the gross proceeds to the detachable stock purchasewarrants (discussed below) and beneficial conversion feature, the total debt discount recognized was equal to the face value of the 2015 convertible notes.Upon conversion in May 2015, the remaining unamortized beneficial conversion feature of approximately $1.5 million was charged to interest expense inthe accompanying condensed consolidated statements of operations and comprehensive loss. Remaining unamortized deferred financing costs of $71,421were also charged to interest expense upon conversion.The 2015 convertible note holders also received detachable stock purchase warrants exercisable for 225,011 shares of common stock at 110% of the IPOprice and exercisable only if the IPO occurred, and then exercisable beginning on the six-month anniversary of the closing of the IPO. Prior to the IPO, as aresult of net settlement features, the stock purchase warrants were considered derivative liabilities, were initially recorded at fair value (resulting in a debtdiscount) and were marked-to-market at each balance sheet date through earnings. As a result of the elimination of the net settlement features in the IPO, thestock purchase warrants were marked to fair value of $0.7 million on May 8, 2015 and then reclassified to equity.Total interest expense on all debt instruments was $143,347 for the year ended December 31, 2016. Total interest expense on all debt instruments was$1,801,320 for year ended December 31, 2015.Note 8 - Stockholders’ EquityAs of December 31, 2016, the Company has 200,000,000 shares of authorized common shares and 25,304,270 issued and outstanding, and 10,000,000 ofauthorized preferred shares, none of which were issued or outstanding.On September 13, 2016, the Company entered into the Sales Agreement with Cowen pursuant to which the Company may offer and sell from time to time, upto an aggregate of $25 million of shares of its common stock through Cowen, as sales agent, with initial sales limited to an aggregate of $11.5 million. Pursuant to the Sales Agreement, Cowen may sell the shares of common stock by any method permitted by law deemed to be an “at the market” offering asdefined in Rule 415 of the Securities Act, including, without limitation, sales made by means of ordinary brokers’ transactions on The NASDAQ CapitalMarket or otherwise at market prices prevailing at the time of sale, in block transactions, or as otherwise directed by the Company. The Company pays Cowencompensation equal to 3.0% of the gross proceeds from the sales of common stock pursuant to the terms of the Sales Agreement. As of December 31, 2016,the Company has sold an aggregate of approximately 3.6 million shares of its common stock under this at the market offering resulting in aggregate netproceeds to the Company of approximately $4.4 million, and gross proceeds of $4.7 million. As of December 31, 2016, remaining availability under the atthe market offering is $6.8 million. Subsequent to December 31, 2016, the Company has sold an aggregate of approximately 2.1 million shares of its commonstock under this at the market offering resulting in aggregate net proceeds to the Company of approximately $2.1 million, and gross proceeds of $2.2 million.Under the initial sales agreement, remaining availability under the at the market offering is $4.6 million.On May 19, 2016 and June 27, 2016, the Company offered and sold units in a private offering to members of management and employees and to accreditedinvestors, including Merck GHI and jVen Capital, each unit consisting of either (i) one share of common stock and a detachable stock purchase warrant topurchase an additional 0.75 shares of common stock, or (ii) one share of non-voting convertible preferred stock and a detachable stock purchase warrant topurchase an additional 0.75 shares of common stock, at a price of $1.14 per unit. The total net proceeds to the Company, after deducting offeringcommissions and expenses was $9.5 million. Pursuant to the private placement the Company issued 6,744,127 shares of common stock, 2,309,428 of SeriesA non-voting convertible preferred stock and stock purchase warrants to acquire an additional 6,790,169 shares of common stock. Under the purchaseagreement, the Company granted registration rights to the investors in the private financing.Each share of Series A non-voting convertible preferred stock was convertible at the option of the holder in whole or in part and from time to time into oneshare of common stock, was entitled to dividends on as “as converted basis” when and if dividends are issued to common stockholders, and participates inliquidation on a pari passu basis with common stockholders. The preferred stock was classified as permanent equity. The stock purchase warrants issued aspart of the units are exercisable $1.3125 per share beginning 90 days after closing for five years, expiring on May 18, 2021. The warrants are classified aspermanent equity at December 31, 2016. In connection with the issuance of Series A non-voting convertible preferred stock, the Company recognized abeneficial conversion feature of $332,550 as a deemed dividend to the preferred stockholders. Holders of the Series A non-voting convertible preferred stocksubsequently converted all 2,309,428 shares of preferred stock into 2,309,428 shares of common stock in July 2016. The shares of preferred stock were retiredand are no longer available for future issuance.F-18 The Company filed a registration statement on Form S-3 on June 13, 2016 to register for resale by the investors, from time to time, of the shares of commonstock acquired, or underlying the warrants issued, in the private offering. On July 20, 2016, the registration statement was declared effective by the SEC.In July 2015, the Company issued 1,136,364 shares of common stock to Merck GHI for cash consideration of $5.0 million (see Note 5).On May 8, 2015, the Company completed its IPO pursuant to which the Company offered and sold 2,850,000 units, each unit consisting of one share ofcommon stock and a detachable stock purchase warrant to purchase an additional share of common stock, at an initial offering price of $6.00 per unit. Of thetotal gross proceeds of $17.1 million, approximately $2.1 million was used to satisfy outstanding demand notes by exchanging such notes for 350,000 unitsin the IPO. After considering the demand notes, and underwriting discounts, commissions and offering expenses of $2.9 million (which were charged toadditional paid-in capital), the total net cash proceeds to the Company was $12.1 million. On the IPO closing date, the underwriters exercised a portion oftheir over-allotment option to acquire an additional 422,500 stock purchase warrants for cash of $4,225.In connection with the IPO, all of the Company’s outstanding Series A redeemable convertible preferred stock, 2014 convertible notes and 2015 convertiblenotes were converted into 7,374,852 shares of common stock. Prior to the IPO, the carrying value of the Series A redeemable convertible preferred stock wasincreased by the accretion of related discounts, issuance costs and accrued but unpaid dividends so that the carrying amount would equal the redemptionamount at the dates the stock becomes redeemable.The stock purchase warrants issued as part of the units (including over-allotment option) are exercisable for 3,272,500 shares of common stock at $6.60 pershare beginning six months after the closing of the IPO for five years, expiring on May 8, 2020. Additionally, the Company issued additional warrants to itsinvestment bankers to purchase 185,250 shares of common stock, on the same terms as the warrants issued with the units. The warrants were valued using theBlack-Scholes option pricing model and are classified as equity.Stock optionsIn 2008, the Board adopted, and the stockholders approved, the 2008 Stock Option and Restricted Stock Plan (the “2008 Plan”), pursuant to which theCompany’s Board of Directors may grant either incentive or non-qualified stock options or shares of restricted stock to directors, key employees, consultantsand advisors.In April 2015, the Board adopted, and the Company’s stockholders approved, the 2015 Equity Incentive Plan (the “2015 Plan”); the 2015 Plan becameeffective upon the execution and delivery of the underwriting agreement for the Company’s IPO. Following the effectiveness of the 2015 Plan, no furthergrants have been made under the 2008 Plan. The 2015 Plan provides for the granting of incentive stock options within the meaning of Section 422 of theCode to employees and the granting of non-qualified stock options to employees, non-employee directors and consultants. The 2015 Plan also provides forthe grants of restricted stock, restricted stock units, stock appreciation rights, dividend equivalents and stock payments to employees, non-employee directorsand consultants.Under the 2015 Plan, the aggregate number of shares of the common stock authorized for issuance may not exceed (1) 1,355,000 plus (2) the sum of thenumber of shares subject to outstanding awards under the 2008 Plan as of the 2015 Plan’s effective date, that are subsequently forfeited or terminated for anyreason before being exercised or settled, plus (3) the number of shares subject to vesting restrictions under the 2008 Plan as of the 2015 Plan’s effective datethat are subsequently forfeited. In addition, the number of shares that have been authorized for issuance under the 2015 Plan will be automatically increasedon the first day of each fiscal year beginning on January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to the lesser of (1) 4% ofthe outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (2) another lesser amount determined by the Company’sBoard of Directors. Shares subject to awards granted under the 2015 Plan that are forfeited or terminated before being exercised or settled, or are not deliveredto the participant because such award is settled in cash, will again become available for issuance under the 2015 Plan. However, shares that have actuallybeen issued shall not again become available unless forfeited. As of December 31, 2016, 669,651 shares remain available for issuance under the 2015 Plan.F-19 For the years ended December 31, 2016 and 2015, the Company recognized stock compensation expense as follows: Year Ended December 31, 2016 2015 Cost of services $6,003 $— Research and development 236,341 240,739 General and administrative 599,550 619,899 Sales and marketing 103,567 584,450 $945,461 $1,445,088 No income tax benefit for stock-based compensation arrangements was recognized in the consolidated statements of operations due to the Company’s netloss position.As of December 31, 2016, the Company had unrecognized expense related to its stock options of $2.2 million, which will be recognized over a weightedaverage period of 1.17 years.A summary of the status of options granted is presented below as of and for the years ended December 31, 2016 and 2015: Number ofOptions Weighted-AverageExercisePrice Weighted-AverageRemainingContractualLife (in years) AggregateIntrinsicValue Outstanding at January 1, 2015 404,272 9.3 $— Granted 1,961,637 $2.68 Exercised (11,472) $0.20 $19,519 Forfeited (193,657) $0.55 Outstanding at December 31, 2015 2,160,780 $2.60 9.1 $1,575,646 Granted 1,463,650 $1.41 Exercised (66,502) $0.36 $79,406 Forfeited (571,687) $3.99 Expired (8,581) $8.49 Outstanding at December 31, 2016 2,977,660 $1.76 8.6 $663,298 Vested and expected to vest 2,977,660 $1.76 8.6 $663,298 Exercisable at December 31, 2016 1,098,504 $0.22 8.0 $421,621 The total fair value of options vested in the years ended December 31, 2016 and 2015, was $1,088,978 and $1,140,079, respectively. The fair value of eachoption grant was estimated at the date of grant using the Black-Scholes option pricing model based on the assumptions below: Year Ended December 31, 2016 2015 Annual dividend — — Expected life (in years) 5.25 - 6.25 5.5 - 6.25 Risk free interest rate 1.2 - 2.2% 1.5 - 1.9% Expected volatility 42.0 - 49.8% 47.7 - 65.0% The Company issued an annual grant on February 22, 2017 of 723,300 options to employees at an exercise price of $1.03 per share.Restricted stock unitsIn the fourth quarter of 2015, the Company granted restricted stock units to acquire 75,000 shares of common stock, with a weighted average grant date fairvalue of $1.70 per share, 18,750 shares of which remain outstanding as of December 31, 2016. 16,666 restricted stock units vested and 39,584 restricted stockunits were forfeited during the year ended December 31, 2016 at a weighted average grant date fair value of $1.70 per share.F-20 Stock purchase warrantsAt December 31, 2016 and 2015, the following warrants to purchase shares of common stock were outstanding: Outstanding at December 31, Issuance ExercisePrice Expiration 2016 2015 August 2007 $7.91 August 2017 8,921 8,921 March 2008 $790.54 March 2018 46 46 November 2009 $7.91 November 2019 6,674 6,674 January 2010 $7.91 January 2020 6,674 6,674 March 2010 $7.91 March 2020 1,277 1,277 November 2011 $7.91 November 2021 5,213 5,213 December 2011 $7.91 December 2021 664 664 March 2012 $109.90 March 2019 4,125 4,125 February 2015 $6.60 February 2025 225,011 225,011 May 2015 $6.60 May 2020 3,457,750 3,457,750 May 2016 $1.31 May 2021 4,739,348 — June 2016 $1.31 May 2021 2,050,821 — 10,506,524 3,716,355 The warrants listed above were issued in connection with various equity, debt, preferred stock or development contract agreements. The warrants issued inFebruary 2015 were initially classified as a liability since the exercise price was variable. The exercise price became fixed as a result of the Company’s IPOand, as such, the warrant liability was marked to fair value at that time and reclassified to equity (see Note 13).Note 9 - Income TaxesAt December 31, 2016 and 2015, the Company had net deferred tax assets of $63,520,548 and $41,554,045, respectively, primarily consisting of NOL carryforwards, research and experimental (“R&E”) credits, and differences between depreciation and amortization recorded for financial statement and taxpurposes. The Company’s net deferred tax assets at December 31, 2016 and 2015 have been offset by a valuation allowance of $63,520,548 and $41,554,045,respectively. The valuation allowance has been recorded due to the uncertainty of realization of the deferred tax assets. The Company’s deferred tax assetsand liabilities as of December 31, 2016 and 2015 are as follows: December 31, 2016 2015 Deferred tax assets: NOL carryforward $60,357,220 $38,797,762 R&E credit carryforward 2,559,479 1,994,478 Share-based compensation 448,534 383,153 Inventory reserve 269,708 226,299 Depreciation 117,629 313,714 Accruals and other 333,126 495,640 Total deferred tax assets 64,085,696 42,211,046 Valuation allowance (63,520,548) (41,554,045)Deferred tax liabilities: Intangible assets (565,148) (657,001)Fixed assets — — Net deferred tax liability $— $— F-21 The difference between the Company’s expected income tax provision (benefit) from applying federal statutory tax rates to the pre-tax loss and actual incometax provision (benefit) relates to the effect of the following: 2016 2015 Federal income tax benefit at statutory rates 34.0% 34.0%State income tax benefit, net of Federal benefit 6.5% 3.3%Change in valuation allowance (37.3)% (32.1)%Change in state tax rates and other (3.2)% (4.5)% 0.0% 0.7% Additionally, despite the NOL carryforwards, the Company may have future tax liability due to alternative minimum tax or state tax requirements. TheCompany has federal NOL carryforwards of $150,950,436 and $132,359,334 at December 31, 2016 and 2015, respectively. The NOL carry forwards begin toexpire in 2022. Utilization of the NOL carryforward may be subject to an annual limitation as provided by Section 382 of the Internal Revenue Code. Therecan be no assurance that the NOL carryforward will ever be fully utilized. To date, the Company has not performed a formal study to determine if any of itsremaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Internal Revenue Codeof 1986, as amended. The Company will continue to monitor this matter going forward. There can be no assurance that the NOL carryforwards will ever befully utilized.Note 10 - CommitmentsOperating leasesThe Company leases a facility in Woburn, Massachusetts under an operating lease that expires January 30, 2022. During the second quarter of 2015, the Company extended the term of its Gaithersburg, Maryland office lease, effective May 7, 2015, through January 31,2021, with one additional five-year renewal at the Company’s election. The Company is responsible for all utilities, repairs, insurance, and taxes under thisoperating lease. Effective July 1, 2015, the Company further modified its lease agreement to add additional leased space to its headquarters. Additionally, theCompany leases office space in Denmark; this lease is currently on a month-to-month basis.Rent expense under the Company’s facility operating leases for the year ended December 31, 2016 and 2015 was $1,000,726 and $683,519, respectively.Capital leasesThe Company leases computer equipment, office furniture, and equipment under various capital leases. The leases expire at various dates through 2021. Theleases require monthly principal and interest payments. Following is a schedule by year of the estimated future minimum payments under all operating andcapital leases as of December 31, 2016: Year ending December 31, CapitalLeases OperatingLeases Total 2017 $204,354 $1,072,448 $1,276,802 2018 113,337 1,205,263 1,318,600 2019 21,266 427,769 449,035 2020 21,266 427,769 449,035 2021 and thereafter 1,773 463,416 465,189 Total $361,996 $3,596,665 $3,958,661 Less: amount representing interest (31,054) Net present value of future minimum lease payments $330,942 Current maturities (184,399) Long-term maturities $146,543 F-22 Assets under capital leases were included in the following balance sheet categories as of December 31: 2016 2015 Laboratory and manufacturing equipment $560,829 $803,500 Office furniture and equipment 64,790 89,140 Computers and network equipment 24,350 153,693 Less accumulated amortization (270,808) (402,066)Capital lease assets, net $379,161 $644,267 Amortization expense associated with equipment under capital leases for the years ended December 31, 2016 and 2015 was $161,606 and $157,036,respectively, and is included within depreciation and amortization expense in the consolidated statements of operations.Registration and other stockholder rightsIn connection with the various investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which theinvestors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registeredofferings of the Company’s common stock.Note 11 - License Agreements, Research Collaborations and Development AgreementsThe Company is a party to five license agreements to acquire certain patent rights and technologies; two related to the FISH product line and three related tothe Argus and MapIt product lines. Royalties are incurred upon the sale of a product or service which utilizes the licensed technology. Certain of theagreements require the Company to pay minimum royalties or license maintenance fees. The Company recognized net royalty expense of $290,491 and$205,147 for the years ended December 31, 2016 and 2015, respectively. Annual future minimum royalty fees are $250,000 under these agreements.In September 2013, the Company entered into a technology development agreement with Hitachi High-Technologies Corporation (“Hitachi”) that includedfixed milestone payments for meeting development milestones under the agreement. Since the milestones were substantive, the Company recognized revenuein the periods in which the substantive milestones were achieved. In addition, the Company received an upfront payment which was recognized on a straight-line basis over the term of the technology development agreement, which ended on December 31, 2015. The Company recognized total revenue of $336,102for the year ended December 31, 2015 (none in 2016), relating to this arrangement.In June 2016, the Company entered into a license agreement with Hitachi, pursuant to which it resolved various matters with respect to previously deliveredmilestones under the technology development agreement and provided a development license and commercial products license to certain technology. Thelicense agreement contains non-contingent multiple elements (the licenses) that the Company determined did not have stand alone value, and a contingentsubstantive milestone. The licenses are treated as a single unit of accounting and the Company will recognize the revenue associated with that unit ofaccounting over the applicable license period. During the year ended December 31, 2016, the Company recognized $137,603 of revenue related to thelicense agreement.Note 12 – Related Party TransactionsIn March 2014, the Company entered into a supply agreement with Fluidigm Corporation (“Fluidigm”) under which Fluidigm supplies the Company with itsmicrofluidic test platform for use in manufacturing the Acuitas MDRO Gene Test. The Company’s CEO and Chairman of the Board of Directors is a directorof Fluidigm. On July 12, 2015, the Company entered into a letter agreement (the “Fluidigm Agreement”) with Fluidigm to expand the companies’ existingrelationship to include collaborating on the development of test kits and custom analytic instruments for identification, screening and surveillance testing ofMDROs. The Fluidigm Agreement also expands the existing Supply Agreement between the Company and Fluidigm, and provides for expansion of the genetargets and organisms to be tested on the Company’s existing CLIA lab-based tests, the Acuitas MDRO Gene Test and the Acuitas Resistome Test, usingFluidigm technologies and products. Additionally, Fluidigm has agreed not to develop or directly collaborate with any third party to develop an FDAapproved or CE marked diagnostic test for the purpose of detecting resistance genes for identified MDROs if the Company meets certain minimum purchasecommitments and other requirements. The initial term of the Fluidigm Agreement is five years. Both parties have the ability to extend the term for anadditional five years. Under the expanded Supply Agreement, the term was extended until March 17, 2018, and the Company has the right to extend the termof the Supply Agreement for up to two additional three-year terms. The Company paid $183,713 related to these agreements in the year ended December 31,2016. The Company paid $295,442 related to these agreements in the year ended December 31, 2015.F-23 Under the agreements with Fluidigm, the Company had purchases of $91,399 in the year ended December 31, 2016. The Company had purchases of$370,539 related to these agreements in the year ended December 31, 2015.In addition, the Company has several capital lease arrangements for laboratory equipment manufactured by Fluidigm. The Company paid $175,475 related tothe leased equipment in the year ended December 31, 2016. The Company paid $119,919 related to the leased equipment in the year ended December 31,2015.In October 2016, the Company entered into an agreement with Merck Sharp & Dohme Corp., a wholly owned subsidiary of Merck Co. & Inc. (“Merck”), anaffiliate of Merck Global Health Innovation Fund (“Merck GHI”), a principal stockholder of the Company and a related party to the Company. Under theagreement, Merck will provide access to its archive of over 200,000 bacterial pathogens. OpGen will initially perform molecular analyses on up to 10,000pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse, and to speed development of OpGen’s rapiddiagnostic products. Merck will gain access to the high-resolution genotype data for the isolates as well as access to OpGen’s Acuitas Lighthouse informaticsto support internal research and development programs. OpGen is required to expend up to $175,000 for the procurement of materials related to the activitiescontemplated by the agreement. As of December 31, 2016, the Company has incurred $32,270 of procurement costs which have been recognized as researchand development expense.In December 2016, the Company entered into an agreement with Healthcare Services & Solutions LLC, an affiliate of Merck GHI, in which the Company willprovide research analysis and reports to the third party. The agreement is worth up to $150,000, of which $135,000 has been recognized as of December 31,2016. At December 31, 2016, the Company had accounts receivable from this customer of $135,000, which individually represented 25% of total accountsreceivable.Note 13 – Fair Value MeasurementsThe Company classifies its financial instruments using a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiersinclude: •Level 1 - defined as observable inputs such as quoted prices in active markets; •Level 2 - defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and •Level 3 - defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptionssuch as expected revenue growth and discount factors applied to cash flow projections.Financial assets and liabilities measured at fair value on a recurring basisThe Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which toclassify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used indetermining fair value and where such inputs lie within the hierarchy.Prior to its IPO, certain stock purchase warrants contained cash settlement features and, accordingly, the Company considered them to be derivative financialinstruments and accounted for them at fair value using level 3 inputs. As a result of the Company’s IPO and elimination of the cash settlement featurespursuant to their terms, those stock purchase warrants were reclassified to equity. For periods prior to the IPO, the Company determined the fair value of thesederivative liabilities using a hybrid valuation method that consisted of a probability weighted expected return method that values the Company’s equitysecurities assuming various possible future economic outcomes while using an option pricing method (that treated all equity linked instruments as calloptions on the Company’s equity value with exercise prices based on the liquidation preference of the Series A Preferred Stock ) to estimate the allocation ofvalue within one or more of the scenarios. Using this hybrid method, unobservable inputs included the Company’s equity value, the exercise price for eachoption value, expected timing of possible economic outcomes such as initial public offering, risk free interest rates and stock price volatility. The followingtables set forth a summary of changes in the fair value of Level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2015(there has been no activity for the year ended December 31, 2016): Description Balance atDecember 31,2014 Establishedin 2015 Change inFair Value Reclassifiedto Equity Balance atDecember 31,2015 Derivative warrant liability $— $72,333 $647,342 $(719,675) $— F-24 Financial assets and liabilities carried at fair value on a non-recurring basisThe Company does not have any financial assets and liabilities measured at fair value on a non-recurring basis.Non-financial assets and liabilities carried at fair value on a recurring basisThe Company does not have any non-financial assets and liabilities measured at fair value on a recurring basis.Non-financial assets and liabilities carried at fair value on a non-recurring basisThe Company measures its long-lived assets, including property and equipment and intangible assets (including goodwill), at fair value on a non-recurringbasis when they are deemed to be impaired. No such fair value impairment was recognized in 2016 and 2015.See Note 4 for a discussion of the fair value of assets acquired and liabilities assumed in the Merger. F-25 EXHIBIT INDEX ExhibitNumber Description 2.1 Agreement and Plan of Merger, dated as of July 14, 2015, among the Registrant, Velox Acquisition Corp, AdvanDx, Inc., Stockholder Partiesand Representatives (incorporated by reference to Exhibit 2.1 of Current Report on Form 8-K, File No. 001-37367, filed on July 16, 2015) 3.1 Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 of Current Report on Form 8-K,File No. 001-37367, filed on May 13, 2015) 3.1.1 Certificate of Correction to Amended and Restated Certificate of Incorporation of the Registrant, dated June 6, 2016 (incorporated byreference to Exhibit 3.1 of Current Report on Form 8-K, filed on June 6, 2016) 3.2 Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 of Form S-1, File No. 333-202478, filed on March3, 2015) 3.3 Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Registrant, dated May 18,2016 (incorporated by reference to Exhibit 3.1 of Current Report on Form 8-K, filed on May 20, 2016) 4.1 Form of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 of Form S-1/A, File No. 333-202478, filed onApril 28, 2015) 4.2 Form of 2015 Warrant to Purchase Common Stock of the Registrant (incorporated by reference to Exhibit 4.6 of Form S-1/A, File No. 333-202478, filed on March 20, 2015) 4.3 Form of Underwriters’ Warrant to Purchase Common Stock of the Registrant (incorporated by reference to Exhibit 4.2 of Current Report onForm 8-K, File No. 001-37367, filed on May 13, 2015) 4.4 Form of Offered Warrant to Purchase Common Stock of the Registrant (incorporated by reference to Exhibit 4.8 of Form S-1/A, File No. 333-202478, filed on April 23, 2015) 4.5 Form of 2016 Warrant to Purchase Common Stock of the Registrant (incorporated by reference to Exhibit 4.1 of Current Report on Form 8-K,filed on May 17, 2016) 10.1 Lease Agreement, dated as of June 30, 2008, between the Registrant and ARE-708 Quince Orchard, LLC (the "Landlord") (incorporated byreference to Exhibit 10.1 of Form S-1/A, file No. 333-202478, filed March 3, 2015) 10.1.1 First Amendment to Lease, dated as of April 4, 2011, between the Registrant and the Landlord (incorporated by reference to Exhibit 10.1.1 ofForm S-1, File No. 333-202478, filed March 3, 2015) 10.1.2 Second Amendment to Lease, dated as of August 15, 2012, between the Registrant and the Landlord (incorporated by reference to Exhibit10.1.2 of Form S-1, File No. 333-202478, filed March 3, 2015) 10.1.3 Third Amendment to Lease, dated as of December 30, 2013, between the Registrant and the Landlord (incorporated by reference to Exhibit10.1.3 of Form S-1, File No. 333-202478, filed March 3, 2015) 10.1.4 Fourth Amendment to Lease, dated as of March 21, 2014, between the Registrant and the Landlord (incorporated by reference to Exhibit 10.4of Form S-1, File No. 333-202478, filed March 3, 2015) 10.1.5 Fifth Amendment to Lease Agreement, dated as of March 20, 2015, between the Registrant and the Landlord (incorporated by reference toExhibit 10.1.5 of Form S-1/A, File No. 333-202478, filed on March 20, 2015) 10.1.6 Sixth Amendment to Lease Agreement, dated as of April 30, 2015, between the Registrant and the Landlord (incorporated by reference toExhibit 10.1.6 of Form S-1/A, File No. 333-202478, filed on May 1, 2015) 10.1.7 Seventh Amendment to Lease Agreement, dated as of June 30, 2015, between the Registrant and the Landlord (incorporated by reference toExhibit 10.1 of Current Report on Form 8-K, filed on July 7, 2015) 10.1.8 Eighth Amendment to Lease Agreement, dated September 8, 2015, between the Registrant and the Landlord (incorporated by reference toExhibit 10.6 of Quarterly Report on Form 10-Q, filed on November 13, 2015) 10.2 Lease Extension #6, dated October 14, 2016, by and between the Registrant and Cummings Properties, LLC (related to AdvanDx facility)(incorporated by reference to Exhibit 10.2 of Quarterly Report on Form 10-Q, filed November 14, 2016)1 ExhibitNumber Description 10.3 Form of Indemnification Agreement between the Registrant and each of its directors and executive officers (incorporated by reference toExhibit 10.2 of Form S-1, File No. 333-202478, filed on March 3, 2015) 10.4#* 2015 Equity Incentive Plan, as amended and restated on February 22, 2017 10.5# Executive Employment, Change in Control and Severance Benefit Agreement, dated April 17, 2015, by and between the Registrant andKevin Krenitsky, M.D. (incorporated by reference to Exhibit 10.17 of Form S-1/A, File No. 333-202478, filed on April 17, 2015) 10.6# Employment Agreement, dated April 17, 2015, by and between the Registrant and Timothy C. Dec (incorporated by reference to Exhibit10.18 of Form S-1/A, File No. 333-202478, filed on April 17, 2015) 10.7 Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.16 of Form S-1/A, File No. 333-202478, filed on April6, 2015) 10.8 Warrant Agreement, dated as of May 8, 2015, between the Registrant and Philadelphia Stock Transfer, Inc., as warrant agent (incorporated byreference to Exhibit 10.1 of Current Report on Form 8-K, filed on May 13, 2015) 10.9.1#* Form of Stock Option Agreement under the 2015 Equity Incentive Plan for employees and consultants 10.9.2#* Form of Stock Option Agreement under the 2015 Equity Incentive Plan for non-employee directors (initial grant) 10.9.3#* Form of Stock Option Agreement under the 2015 Equity Incentive Plan for non-employee directors (annual grant) 10.10#* Form of RSU Award Agreement under 2015 Equity Incentive Plan 10.11 Common Stock and Note Purchase Agreement, dated as of July 14, 2015, between the Registrant and Merck Global Health Innovation Fund,LLC (incorporated by reference to Exhibit 10.1 of Current Report on Form 8-K, filed on July 16, 2015) 10.12 Senior Secured Promissory Note, dated as of July 14, 2015, between the Registrant and Merck Global Health Innovation Fund, LLC(incorporated by reference to Exhibit 10.1 of Current Report on Form 8-K, filed on July 16, 2015) 10.13 Third Amended and Restated Investors’ Rights Agreement, dated as of December 18, 2013, among the Registrant and, certain investors(registration rights provisions) (incorporated by reference to Exhibit 4.2 of Form S-1, File No. 333-202478, filed March 3, 2015) 10.14 Registration Rights Agreement, dated as of July 14, 2015, among the Registrant, Merck Global Health Innovation Fund, LLC, SLS Invest ABand LD Pensions (incorporated by reference to Exhibit 10.1 of Current Report on Form 8-K, filed on July 16, 2015) 10.15± Letter Agreement, dated July 12, 2015, between the Registrant and Fluidigm Corporation (incorporated by reference to Exhibit 10.5 ofQuarterly Report on Form 10-Q, filed on August 14, 2015) 10.16 Securities Purchase Agreement, dated May 12, 2016, by and between the Registrant the Purchasers party thereto (incorporated by reference toExhibit 10.1 of Current Report on Form 8-K, filed on May 17, 2016) 10.17 Amended and Restated Securities Purchase Agreement, dated May 18, 2016, by and between the Registrant and the Purchasers party thereto(incorporated by reference to Exhibit 10.1 of Current Report on Form 8-K, filed on May 20, 2016) 10.18# Stock Option Award Agreement, dated April 28, 2016, by and between the Registrant and Evan Jones (incorporated by reference to Exhibit10.5 of Quarterly Report on Form 10-Q, filed on August 11, 2016) 10.19 Confidential Separation Agreement and General Release, dated September 1, 2016, by and between the Registrant and Kevin Krenitsky, M.D.(incorporated by reference to Exhibit 10.1 of Current Report on Form 8-K, filed on September 9, 2016) 10.20 Common Stock Sales Agreement, dated September 13, 2016, by and between the Registrant and Cowen and Company, LLC (incorporated byreference to Exhibit 10.1 of Current Report on Form 8-K, filed on September 14, 2016) 21.1* Subsidiaries of the Registrant 23.1* Consent of CohnReznick LLP 31.1* Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a)2 ExhibitNumber Description 31.2* Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) 32.1* Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101* Interactive data files pursuant to Rule 405 of Regulation S-T; (i) the Balance Sheets, (ii) the Statements of Operations, (iii) the Statements ofStockholders’ Equity (Deficit), (iv) Statements of Cash Flows and (v) the Notes to the Financial Statements *Filed herewith#Management contract or compensatory arrangement.±Confidential treatment has been granted for certain provisions of this agreement pursuant to an application for confidential treatment filed with theSecurities and Exchange Commission on August 15, 2015. Such provisions have been separately filed with the Commission.3Exhibit 10.4OPGEN, INC.2015 EQUITY INCENTIVE PLAN,as Amended and Restated ARTICLE 1.PURPOSEThe purpose of the OpGen, Inc. 2015 Equity Incentive Plan, as amended and restated (as it may be further amended orrestated from time to time, the “Plan”) is to promote the success and enhance the value of OpGen, Inc. (the “Company”) by aligningthe individual interests of the members of the Board, Employees, and Consultants with those of Company stockholders and byproviding such individuals with an equity-based incentive for outstanding performance. The Plan is further intended to provideflexibility to the Company in its ability to motivate, attract, and retain the services of members of the Board, Employees, andConsultants upon whose judgment, interest and special effort the successful conduct of the Company’s operation is largely dependent.ARTICLE 2.DEFINITIONS AND CONSTRUCTIONWherever the following terms are used in the Plan they have the meanings specified below, unless the context clearlyindicates otherwise. The singular pronoun shall include the plural where the context so indicates.2.1“Administrator” means the entity that conducts the general administration of the Plan as provided inArticle 12. With reference to the duties of the Committee under the Plan which have been delegated to one or more persons pursuantto Section 12.6, or which the Board has assumed, the term “Administrator” shall refer to such person(s) unless the Committee or theBoard has revoked such delegation or the Board has terminated the assumption of such duties.2.2“Applicable Accounting Standards” means Generally Accepted Accounting Principles in the UnitedStates, International Financial Reporting Standards or such other accounting principles or standards as may apply to the Company’sfinancial statements under United States federal securities laws from time to time.2.3“Applicable Law” means any applicable law, including without limitation: (a) provisions of the Code,the Securities Act, the Exchange Act and any rules or regulations thereunder; (b) corporate, securities, tax or other laws, statutes,rules, requirements or regulations, whether federal, state, local or foreign; and (c) rules of any securities exchange or automatedquotation system on which the Shares are listed, quoted or traded.2.4“Award” means an Option, a Restricted Stock award, a Restricted Stock Unit award, a Performanceaward, a Dividend Equivalent award, a Stock Payment award or a Stock Appreciation Right, which may be awarded or grantedunder the Plan (collectively, “Awards”).  2.5“Award Agreement” means any written notice, agreement, terms and conditions, contract or otherinstrument or document evidencing an Award, including through electronic medium, which shall contain such terms and conditionswith respect to an Award as the Administrator shall determine consistent with the Plan.2.6“Board” means the Board of Directors of the Company.2.7“Change in Control” means and includes each of the following:(a)A transaction or series of transactions (other than an offering of Common Stock to thegeneral public through a registration statement filed with the Securities and Exchange Commission) whereby any “person” or related“group” of “persons” (as such terms are used in Sections 13(d) and 14(d)(2) of the Exchange Act) (other than the Company, any of itsSubsidiaries, an employee benefit plan maintained by the Company or any of its Subsidiaries or a “person” that, prior to suchtransaction, directly or indirectly controls, is controlled by, or is under common control with, the Company) directly or indirectlyacquires beneficial ownership (within the meaning of Rule 13d-3 under the Exchange Act) of securities of the Company possessingmore than 50% of the total combined voting power of the Company’s securities outstanding immediately after such acquisition; or(b)The consummation by the Company (whether directly involving the Company orindirectly involving the Company through one or more intermediaries) of (x) a merger, consolidation, reorganization, or businesscombination or (y) a sale or other disposition of all or substantially all of the Company’s assets in any single transaction or series ofrelated transactions or (z) the acquisition of assets or stock of another entity, in each case other than a transaction:(i)which results in the Company’s voting securities outstandingimmediately before the transaction continuing to represent (either by remaining outstanding or by being converted into voting securitiesof the Company or the person that, as a result of the transaction, controls, directly or indirectly, the Company or owns, directly orindirectly, all or substantially all of the Company’s assets or otherwise succeeds to the business of the Company (the Company or suchperson, the “Successor Entity”)) directly or indirectly, at least a majority of the combined voting power of the Successor Entity’soutstanding voting securities immediately after the transaction, and(ii)after which no person or group beneficially owns voting securitiesrepresenting 50% or more of the combined voting power of the Successor Entity; provided, however, that no person or group shall betreated for purposes of this Section 2.7(b)(ii) as beneficially owning 50% or more of the combined voting power of the SuccessorEntity solely as a result of the voting power held in the Company prior to the consummation of the transaction; or(c)The Company’s stockholders approve a liquidation or dissolution of the Company.In addition, if a Change in Control constitutes a payment event with respect to any portion of an Award that provides for the deferral ofcompensation and is subject to Section 409A of the Code,2 the transaction or event described in subsection (a), (b), (c) or (d) with respect to such Award (or portion thereof) must also constitute a“change in control event,” as defined in Treasury Regulation Section 1.409A-3(i)(5) to the extent required by Section 409A.The Board shall have full and final authority, which shall be exercised in its sole discretion, to determine conclusively whether aChange in Control has occurred pursuant to the above definition, and the date of the occurrence of such Change in Control and anyincidental matters relating thereto; provided that any exercise of authority in conjunction with a determination of whether a Change inControl is a “change in control event” as defined in Treasury Regulation Section 1.409A-3(i)(5) shall be consistent with suchregulation.2.8“Code” means the Internal Revenue Code of 1986, as amended from time to time, together with theregulations and official guidance promulgated thereunder.2.9“Committee” means the Compensation Committee of the Board, or another committee orsubcommittee of the Board or the Compensation Committee of the Board, appointed as provided in Section 12.1.2.10“Common Stock” means the common stock of the Company, $0.01 par value per share.2.11“Company” has the meaning set forth in Article 1.2.12“Consultant” means any consultant or adviser engaged to provide services to the Company or anySubsidiary that qualifies as a consultant under the applicable rules of the Securities and Exchange Commission for registration ofshares on a Form S-8 Registration Statement.2.13“Director” means a member of the Board, as constituted from time to time.2.14“Dividend Equivalent” means a right to receive the equivalent value (in cash or Shares) of dividendspaid on Shares, awarded under Section 9.2.2.15“DRO” means a domestic relations order as defined by the Code or Title I of the EmployeeRetirement Income Security Act of 1974, as amended from time to time, or the rules thereunder.2.16“Effective Date” means the day prior to the Public Trading Date.2.17“Eligible Individual” means any person who is an Employee, a Consultant or a Non-EmployeeDirector, as determined by the Committee.2.18“Employee” means any officer or other employee (as determined in accordance with Section3401(c) of the Code and the Treasury Regulations thereunder) of the Company or of any Subsidiary.2.19“Equity Restructuring” means a nonreciprocal transaction between the Company and all of its then-current stockholders, such as a stock dividend, stock split, spin-3 off, or recapitalization through a large, nonrecurring cash dividend, that affects the number or kind of Shares (or other securities ofthe Company) or the share price of Common Stock (or other securities) and causes a change in the per-share value of the CommonStock underlying outstanding Awards.2.20“Exchange Act” means the Securities Exchange Act of 1934, as amended from time to time.2.21“Expiration Date” has the meaning given to such term in Section 13.1.2.22“Fair Market Value” means, as of any given date, the value of a Share determined as follows:(a)If the Common Stock is listed on any (i) established securities exchange (such as theNew York Stock Exchange, the NASDAQ Global Market, the NASDAQ Global Select Market and the NASDAQ Capital Market),(ii) national market system or (iii) automated quotation system on which the Shares are listed, quoted or traded, its Fair Market Valueshall be the closing sales price for a Share as quoted on such exchange or system for such date or, if there is no closing sales price for aShare on the date in question, the closing sales price for a Share on the last preceding date for which such quotation exists, as reportedin The Wall Street Journal or such other source as the Administrator deems reliable;(b)If the Common Stock is not listed on an established securities exchange, national marketsystem or automated quotation system, but the Common Stock is regularly quoted by a recognized securities dealer, its Fair MarketValue shall be the mean of the high bid and low asked prices for such date or, if there are no high bid and low asked prices for a Shareon such date, the high bid and low asked prices for a Share on the last preceding date for which such information exists, as reported inThe Wall Street Journal or such other source as the Administrator deems reliable; or(c)If the Common Stock is neither listed on an established securities exchange, nationalmarket system or automated quotation system nor regularly quoted by a recognized securities dealer, its Fair Market Value shall beestablished by the Board or Committee in good faith.2.23“Greater Than 10% Stockholder” means an individual then owning (within the meaning of Section424(d) of the Code) more than 10% of the total combined voting power of all classes of stock of the Company or any subsidiarycorporation (as defined in Section 424(f) of the Code) or parent corporation thereof (as defined in Section 424(e) of the Code).2.24“Holder” means a person who has been granted an Award.2.25“Incentive Stock Option” means an Option that is intended to qualify as an incentive stock optionand conforms to the applicable provisions of Section 422 of the Code.2.26“Non-Employee Director” means a Director of the Company who is not an Employee.4 2.27“Non-Employee Director Compensation Program” has the meaning set forth in Section 4.5.2.28“Non-Qualified Stock Option” means an Option that is not an Incentive Stock Option.2.29“Option” means a right to purchase Shares at a specified exercise price, granted under Article 5. AnOption shall be either a Non-Qualified Stock Option or an Incentive Stock Option; provided, however, that Options granted to Non-Employee Directors and Consultants shall only be Non-Qualified Stock Options.2.30“Option Term” has the meaning set forth in Section 5.4.2.31“Performance Award” means a cash bonus award, stock bonus award, performance award orincentive award that is paid in cash, Shares or a combination of both, awarded under Section 9.1.2.32“Performance Goals” means, for a Performance Period, one or more goals established by theAdministrator for the Performance Period. The Performance Goals may be expressed in terms of overall Company performance orthe performance of a Subsidiary, division, business unit, or an individual.2.33“Performance Period” means one or more periods of time, which may be of varying and overlappingdurations, as the Administrator may select, over which the attainment of one or more Performance Goals will be measured for thepurpose of determining a Holder’s right to, and the payment of, an Award.2.34“Performance Stock Unit” means a Performance Award awarded under Section 9.1 which isdenominated in units of value including dollar value of Shares.2.35“Permitted Transferee” means, with respect to a Holder, any “family member” of the Holder, asdefined in the instructions to Form S-8 under the Securities Act, or any other transferee specifically approved by the Administrator,after taking into account Applicable Law.2.36“Plan” has the meaning set forth in Article 1.2.37“Prior Plan” means the OpGen, Inc. 2008 Stock Option and Restricted Stock Plan, as such plan maybe amended from time to time.2.38“Prior Plan Award” means an award outstanding under the Prior Plan as of the Effective Date.2.39“Program” means any program adopted by the Administrator pursuant to the Plan containing theterms and conditions intended to govern a specified type of Award granted under the Plan and pursuant to which such type ofAward may be granted under the Plan.5 2.40“Public Trading Date” means the first date upon which Common Stock is listed (or approved forlisting) upon notice of issuance on any securities exchange or designated (or approved for designation) upon notice of issuance as anational market security on an interdealer quotation system.2.41“Restricted Stock” means Common Stock awarded under Article 7 that is subject to certainrestrictions and may be subject to risk of forfeiture or repurchase.2.42“Restricted Stock Units” means the right to receive Shares awarded under Article 8.2.43“Securities Act” means the Securities Act of 1933, as amended.2.44“Shares” means shares of Common Stock.2.45“Stock Appreciation Right” means a stock appreciation right granted under Article 10.2.46“Stock Appreciation Right Term” has the meaning set forth in Section 10.5.2.47“Stock Payment” means (a) a payment in the form of Shares, or (b) an option or other right topurchase Shares, as part of a bonus, deferred compensation or other arrangement, awarded under Section 9.3.2.48“Subsidiary” means any entity (other than the Company), whether domestic or foreign, in anunbroken chain of entities beginning with the Company if each of the entities other than the last entity in the unbroken chainbeneficially owns, at the time of the determination, securities or interests representing at least fifty percent (50%) of the totalcombined voting power of all classes of securities or interests in one of the other entities in such chain.2.49“Substitute Award” means an Award granted under the Plan upon the assumption of, or insubstitution for, outstanding equity awards previously granted by a company or other entity in connection with a corporatetransaction, such as a merger, combination, consolidation or acquisition of property or stock; provided, however, that in no eventshall the term “Substitute Award” be construed to refer to an award made in connection with the cancellation and repricing of anOption or Stock Appreciation Right.2.50“Termination of Service” means:(a)As to a Consultant, the time when the engagement of a Holder as a Consultant to theCompany or a Subsidiary is terminated for any reason, with or without cause, including, without limitation, by resignation, discharge,death or retirement, but excluding a termination where the Consultant simultaneously commences or remains in employment or servicewith the Company or any Subsidiary.(b)As to a Non-Employee Director, the time when a Holder who is a Non-EmployeeDirector ceases to be a Director for any reason, including, without limitation, a6 termination by resignation, failure to be elected, death or retirement, but excluding terminations where the Holder simultaneouslycommences or remains in employment or service with the Company or any Subsidiary.(c)As to an Employee, the time when the employee-employer relationship between aHolder and the Company or any Subsidiary is terminated for any reason, including, without limitation, a termination by resignation,discharge, death, disability or retirement; but excluding terminations where the Holder simultaneously commences or remains inemployment or service as a Consultant or Non-Employee Director with the Company or any Subsidiary.The Administrator, in its sole discretion, shall determine the effect of all matters and questions relating to any Termination ofService, including, without limitation, the question of whether a Termination of Service resulted from a discharge for “cause” and allquestions of whether particular leaves of absence constitute a Termination of Service; provided, however, that, with respect toIncentive Stock Options, unless the Administrator otherwise provides in the terms of the Program, the Award Agreement or otherwise,or as otherwise required by Applicable Law, a leave of absence, change in status from an employee to an independent contractor orother change in the employee-employer relationship shall constitute a Termination of Service only if, and to the extent that, such leaveof absence, change in status or other change interrupts employment for the purposes of Section 422(a)(2) of the Code and the then-applicable regulations and revenue rulings under said Section. For purposes of the Plan, a Holder’s employee-employer relationship orconsultancy relations shall be deemed to be terminated in the event that the Subsidiary employing or contracting with such Holderceases to remain a Subsidiary following any merger, sale of stock or other corporate transaction or event (including, without limitation,a spin-off).ARTICLE 3.SHARES SUBJECT TO THE PLAN3.1Number of Shares.(a)Subject to adjustment as provided in Sections 3.1(b) and 13.2, the aggregate number ofShares which may be issued or transferred pursuant to Awards under the Plan is the sum of (i) 1,355,000 plus (ii) any Shares which asof the Effective Date are subject to awards granted under the Prior Plan which are forfeited, or lapse unexercised; and (iii) an annualincrease on the first day of each calendar year beginning January 1, 2016 and ending on and including January 1, 2025 equal to thelesser of (A) four percent (4%) of the Shares outstanding (on an as-converted basis) on the final day of the immediately precedingcalendar year, and (B) such smaller number of Shares as determined by the Board; provided, however, no more than 4,000,000 Sharesmay be issued upon the exercise of Incentive Stock Options. From and after the Effective Date, no future awards shall be grantedunder the Prior Plan; however, any Prior Plan Award shall continue to be subject to the terms and conditions of the Prior Plan. (b)To the extent all or a portion of an Award is forfeited, expires or lapses for any reason,or is settled for cash without delivery of Shares to the Holder, any Shares subject to such Award, or portion thereof, to the extent ofsuch forfeiture, expiration, lapse or cash settlement, shall again be or shall become, as applicable, available for the future grant of an7 Award pursuant to the Plan. Any Shares repurchased by or surrendered to the Company pursuant to Section 7.4 or in connection withany Prior Plan Award so that such Shares are returned to the Company shall again be or shall become, as applicable, available for thefuture grant of an Award pursuant to the Plan. The payment of Dividend Equivalents in cash in conjunction with any outstandingAwards shall not be counted against the Shares available for issuance under the Plan. Any shares acquired by the Company from thenet settlement of an Award as contemplated by Section 11.2 of this Plan or in connection with any Prior Plan Award shall not beavailable for future grant of an Award pursuant to the Plan. Notwithstanding the provisions of this Section 3.1(b), no Shares mayagain be or, as applicable, may become eligible to be, optioned, granted or awarded if such action would cause an Incentive StockOption to fail to qualify as an incentive stock option under Section 422 of the Code.(c)Substitute Awards shall not reduce the Shares authorized for grant under the Plan.Additionally, in the event that a company acquired by the Company or any Subsidiary or with which the Company or any Subsidiarycombines has shares available under a pre-existing plan approved by stockholders and not adopted in contemplation of such acquisitionor combination, the shares available for grant pursuant to the terms of such pre-existing plan (as adjusted, to the extent appropriate,using the exchange ratio or other adjustment or valuation ratio or formula used in such acquisition or combination to determine theconsideration payable to the holders of common stock of the entities party to such acquisition or combination) may be used for Awardsunder the Plan and shall not reduce the Shares authorized for grant under the Plan; provided that Awards using such available Sharesshall not be made after the date awards or grants could have been made under the terms of the pre-existing plan, absent the acquisitionor combination, and shall only be made to individuals who were not employed by or providing services to the Company or itsSubsidiaries immediately prior to such acquisition or combination.3.2Stock Distributed. Any Shares distributed pursuant to an Award may consist, in whole or in part, ofauthorized and unissued Common Stock, treasury Common Stock or Common Stock purchased on the open market.ARTICLE 4.GRANTING OF AWARDS4.1Participation. The Administrator may, from time to time, select from among all Eligible Individuals,those to whom an Award shall be granted and shall determine the nature and amount of each Award, which shall not be inconsistentwith the requirements of the Plan. Except as provided in Section 4.5 regarding the grant of Awards pursuant to the Non-EmployeeDirector Compensation Program, no Eligible Individual has any right to be granted an Award pursuant to the Plan.4.2Award Agreement. Each Award shall be evidenced by an Award Agreement that sets forth the terms,conditions and limitations for such Award, which may include the term of the Award, the provisions applicable in the event of theHolder’s Termination of Service, to the extent different from those set forth herein, and the Company’s authority to unilaterally orbilaterally amend, modify, suspend, cancel or rescind an Award. Award8 Agreements evidencing Incentive Stock Options shall contain such terms and conditions as may be necessary to meet the applicableprovisions of Section 422 of the Code.4.3Limitations Applicable to Section 16 Persons. Notwithstanding any other provision of the Plan, thePlan, and any Award granted or awarded to any individual who is then subject to Section 16 of the Exchange Act, shall be subjectto any additional limitations set forth in any applicable exemptive rule under Section 16 of the Exchange Act (including Rule 16b‑3of the Exchange Act and any amendments thereto) that are requirements for the application of such exemptive rule. To the extentpermitted by Applicable Law, the Plan and Awards granted or awarded hereunder shall be deemed amended to the extent necessaryto conform to such applicable exemptive rule.4.4At-Will Employment; Voluntary Participation. Nothing in the Plan or in any Program or AwardAgreement hereunder shall confer upon any Holder any right to continue in the employ of, or as a Director or Consultant for, theCompany or any Subsidiary, or shall interfere with or restrict in any way the rights of the Company and any Subsidiary, whichrights are hereby expressly reserved, to discharge any Holder at any time for any reason whatsoever, with or without cause, and withor without notice, or to terminate or change all other terms and conditions of employment or engagement, except to the extentexpressly provided otherwise in a written agreement between the Holder and the Company or any Subsidiary. Participation by eachHolder in the Plan shall be voluntary and nothing in the Plan shall be construed as mandating that any Eligible Individual shallparticipate in the Plan.4.5Non-Employee Director Awards. The Administrator, in its sole discretion, may provide that Awardsgranted to Non-Employee Directors shall be granted pursuant to a written nondiscretionary formula established by the Administrator(the “Non-Employee Director Compensation Program”), subject to the limitations of the Plan. The Non-Employee DirectorCompensation Program shall set forth the type of Award(s) to be granted to Non-Employee Directors, the number of Shares to besubject to Non-Employee Director Awards, the conditions on which such Awards shall be granted, become exercisable and/orpayable and expire, and such other terms and conditions as the Administrator shall determine in its sole discretion. The Non-Employee Director Compensation Program may be modified by the Administrator from time to time in its sole discretion.4.6Stand-Alone and Tandem Awards. Awards granted pursuant to the Plan may, in the sole discretion ofthe Administrator, be granted either alone, in addition to, or in tandem with, any other Award granted pursuant to the Plan. Awardsgranted in addition to or in tandem with other Awards may be granted either at the same time as or at a different time from the grantof such other Awards.ARTICLE 5.GRANTING OF OPTIONS5.1Granting of Options to Eligible Individuals. The Administrator is authorized to grant Options toEligible Individuals from time to time, in its sole discretion, on such terms and conditions as it may determine, which shall not beinconsistent with the Plan.9 5.2Qualification of Incentive Stock Options. No Incentive Stock Option shall be granted to any personwho is not an Employee. No person who qualifies as a Greater Than 10% Stockholder may be granted an Incentive Stock Optionunless such Incentive Stock Option conforms to the applicable provisions of Section 422 of the Code. Any Incentive Stock Optiongranted under the Plan may be modified by the Administrator, with the consent of the Holder, to disqualify such Option fromtreatment as an “incentive stock option” under Section 422 of the Code. To the extent that the aggregate Fair Market Value of stockwith respect to which “incentive stock options” (within the meaning of Section 422 of the Code, but without regard to Section422(d) of the Code) are exercisable for the first time by a Holder during any calendar year under the Plan, and all other plans of theCompany and any parent or subsidiary corporation thereof (each as defined in Section 424(e) and 424(f) of the Code, respectively),exceeds $100,000, the Options shall be treated as Non-Qualified Stock Options to the extent required by Section 422 of the Code.The rule set forth in the immediately preceding sentence shall be applied by taking Options and other “incentive stock options” intoaccount in the order in which they were granted and the Fair Market Value of stock shall be determined as of the time the respectiveoptions were granted.5.3Option Exercise Price. The exercise price per Share subject to each Option shall be set by theAdministrator, but shall not be less than 100% of the Fair Market Value of a Share on the date the Option is granted (or, as toIncentive Stock Options, on the date the Option is modified, extended or renewed for purposes of Section 424(h) of the Code). Inaddition, in the case of Incentive Stock Options granted to a Greater Than 10% Stockholder, such price shall not be less than 110%of the Fair Market Value of a Share on the date the Option is granted (or the date the Option is modified, extended or renewed forpurposes of Section 424(h) of the Code).5.4Option Term.(a)The term of each Option (the “Option Term”) shall be set by the Administrator in its solediscretion; provided, however, that the Option Term shall not be more than ten (10) years from the date the Option is granted, or five(5) years from the date an Incentive Stock Option is granted to a Greater Than 10% Stockholder. The Administrator shall determine thetime period, including the time period following a Termination of Service, to the extent different from that set forth herein, duringwhich the Holder has the right to exercise the vested Options, which time period may not extend beyond the last day of the OptionTerm. Except as limited by the requirements of Section 409A or Section 422 of the Code and regulations and rulings thereunder or thefirst sentence of this Section 5.4, the Administrator may extend the Option Term of any outstanding Option, and may extend the timeperiod during which vested Options may be exercised, in connection with any Termination of Service of the Holder, and may amend,subject to Section 13.1, any other term or condition of such Option relating to such a Termination of Service.(b)Unless the Administrator expressly provides otherwise in an Award Agreement or byaction following the grant of the Option, immediately upon the Termination of Service of a Holder, the unvested portion of any Optionheld by such Holder or such Holder’s Permitted Transferee will terminate. The vested balance of any Option, to the extent exercisable,will remain exercisable for the lesser of: (i) a period ending on the latest date on which such10 Option could have been exercised without regard to the Termination of Service and (ii)(A) with respect to a Termination of Service ofa Holder who was a Non-Employee Director, a period of one year, (B) with respect to a Termination of Service of a Holder inconnection with the death or disability of the Holder, a period of one hundred eighty (180) days, and (C) with respect to any otherTermination of Service, a period of ninety (90) days. Notwithstanding the foregoing, the Administrator may determine in its solediscretion that the reasons for a Termination of Service justify immediate termination of an Option.5.5Option Vesting.(a)The period during which the right to exercise, in whole or in part, an Option vests in theHolder shall be set by the Administrator and the Administrator may determine that an Option may not be exercised in whole or in partfor a specified period after it is granted. Such vesting may be based on service with the Company or any Subsidiary or anyperformance criteria selected by the Administrator, and, except as limited by the Plan, at any time after the grant of an Option, theAdministrator, in its sole discretion and subject to whatever terms and conditions it selects, may accelerate the period during which anOption vests.(b)No portion of an Option which is unexercisable at a Holder’s Termination of Serviceshall thereafter become exercisable, except as may be otherwise provided by the Administrator either in the applicable Program, theAward Agreement evidencing the grant of an Option, or by action of the Administrator following the grant of the Option.(c)Notwithstanding any provisions of this Agreement, any acceleration of vestingprovisions in an employment agreement with respect to Options will supersede the provisions of this Plan and the related AwardAgreement, unless the employment agreement specifically states otherwise.5.6Substitute Awards. Notwithstanding the foregoing provisions of this Article 5 to the contrary, in thecase of an Option that is a Substitute Award, the price per share of the Shares subject to such Option may be less than the FairMarket Value per share on the date of grant; provided that the excess of: (a) the aggregate Fair Market Value (as of the date suchSubstitute Award is granted) of the Shares subject to the Substitute Award, over (b) the aggregate exercise price thereof does notexceed the excess of: (x) the aggregate fair market value (as of the time immediately preceding the transaction giving rise to theSubstitute Award, such fair market value to be determined by the Administrator) of the shares of the predecessor entity that weresubject to the grant assumed or substituted for by the Company, over (y) the aggregate exercise price of such shares.5.7Substitution of Stock Appreciation Rights. The Administrator may provide in the applicable Programor the Award Agreement evidencing the grant of an Option that the Administrator, in its sole discretion, shall have the right tosubstitute a Stock Appreciation Right for such Option at any time prior to or upon exercise of such Option; provided that such StockAppreciation Right shall be exercisable with respect to the same number of Shares for which such substituted Option would havebeen exercisable, and shall also have the same exercise price, vesting schedule and remaining term as the substituted Option.11 ARTICLE 6.EXERCISE OF OPTIONS6.1Partial Exercise. An exercisable Option may be exercised in whole or in part. However, an Optionshall not be exercisable with respect to fractional Shares and the Administrator may require that, by the terms of the Option, a partialexercise must be with respect to a minimum number of Shares.6.2Manner of Exercise. All or a portion of an exercisable Option shall be deemed exercised upondelivery of all of the following to the Secretary of the Company, the stock plan administrator of the Company or such other personor entity designated by the Administrator, or his, her or its office, as applicable:(a)A written or electronic notice complying with the applicable rules established by theAdministrator stating that the Option, or a portion thereof, is exercised. The notice shall be signed by the Holder or other person thenentitled to exercise the Option or such portion of the Option;(b)Such representations and documents as the Administrator, in its sole discretion, deemsnecessary or advisable to effect compliance with Applicable Law. The Administrator, in its sole discretion, may also take whateveradditional actions it deems appropriate to effect such compliance including, without limitation, placing legends on share certificates andissuing stop-transfer notices to agents and registrars;(c)In the event that the Option shall be exercised pursuant to Section 11.3 by any person orpersons other than the Holder, appropriate proof of the right of such person or persons to exercise the Option, as determined in the solediscretion of the Administrator; and(d)Full payment of the exercise price and applicable withholding taxes to the stock planadministrator of the Company for the Shares with respect to which the Option, or portion thereof, is exercised, in a manner permittedby Sections 11.1 and 11.2.6.3Notification Regarding Disposition. The Holder shall give the Company prompt written or electronicnotice of any disposition of Shares acquired by exercise of an Incentive Stock Option which occurs within (a) two years from the dateof grant (including the date the Option is modified, extended or renewed for purposes of Section 424(h) of the Code) of such Option tosuch Holder, or (b) one year after the transfer of such Shares to such Holder.ARTICLE 7.AWARD OF RESTRICTED STOCK7.1Award of Restricted Stock.(a)The Administrator is authorized to grant Restricted Stock to Eligible Individuals, andshall determine the terms and conditions, including the restrictions applicable to each award of Restricted Stock, which terms andconditions shall not be inconsistent with the Plan, and may impose such conditions on the issuance of such Restricted Stock as it deemsappropriate.12 (b)The Administrator shall establish the purchase price, if any, and form of payment forRestricted Stock; provided, however, that if a purchase price is charged, such purchase price shall be no less than the par value, if any,of the Shares to be purchased, unless otherwise permitted by Applicable Law. In all cases, legal consideration shall be required foreach issuance of Restricted Stock.7.2Rights as Stockholder. Subject to Section 7.4, upon issuance of Restricted Stock, the Holder shallhave, unless otherwise provided by the Administrator, all the rights of a stockholder with respect to said Shares, subject to therestrictions in the applicable Program or in each individual Award Agreement, including the right to receive all dividends and otherdistributions paid or made with respect to the Shares; provided, however, that, in the sole discretion of the Administrator, anyextraordinary distributions with respect to the Shares shall be subject to the restrictions set forth in Section 7.3.7.3Restrictions. All shares of Restricted Stock (including any shares received by Holders thereof withrespect to shares of Restricted Stock as a result of stock dividends, stock splits or any other form of recapitalization) shall, in theterms of the applicable Program or in each individual Award Agreement, be subject to such restrictions and vesting requirements asthe Administrator shall provide. Such restrictions may include, without limitation, restrictions concerning voting rights andtransferability and such restrictions may lapse separately or in combination at such times and pursuant to such circumstances orbased on such criteria as selected by the Administrator, including, without limitation, criteria based on the Holder’s duration ofemployment, directorship or consultancy with the Company, Company performance, individual performance or other criteriaselected by the Administrator. By action taken after the Restricted Stock is issued, the Administrator may, on such terms andconditions as it may determine to be appropriate, accelerate the vesting of such Restricted Stock by removing any or all of therestrictions imposed by the terms of the applicable Program or Award Agreement. Restricted Stock may not be sold or encumbereduntil all restrictions are terminated or expire. Notwithstanding any provisions of this Agreement, any acceleration of vestingprovisions in an employment agreement with respect to Restricted Stock will supersede the provisions of this Plan and the relatedAward Agreement, unless the employment agreement specifically states otherwise.7.4Repurchase or Forfeiture of Restricted Stock. Except as otherwise determined by the Administrator atthe time of the grant of the Award or thereafter, if no price was paid by the Holder for the Restricted Stock, upon a Termination ofService during the applicable restriction period, the Holder’s rights in unvested Restricted Stock then subject to restrictions shalllapse, and such Restricted Stock shall be surrendered to the Company and cancelled without consideration. If a price was paid bythe Holder for the Restricted Stock, upon a Termination of Service during the applicable restriction period, the Company shall havethe right to repurchase from the Holder the unvested Restricted Stock then subject to restrictions at a cash price per share equal to theprice paid by the Holder for such Restricted Stock or such other amount as may be specified in the applicable Program or AwardAgreement. Notwithstanding the foregoing, the Administrator, in its sole discretion, may provide that upon certain events, includinga Change in Control, the Holder’s death, retirement or disability or any other specified Termination of Service or any other event,the Holder’s rights in unvested13 Restricted Stock shall not lapse, such Restricted Stock shall vest and, if applicable, the Company shall not have a right ofrepurchase.7.5Certificates for Restricted Stock. Restricted Stock granted pursuant to the Plan may be evidenced insuch manner as the Administrator shall determine. Certificates or book entries evidencing shares of Restricted Stock shall include anappropriate legend referring to the terms, conditions, and restrictions applicable to such Restricted Stock. The Company, in its solediscretion, may (a) retain physical possession of any stock certificate evidencing shares of Restricted Stock until the restrictionsthereon shall have lapsed and/or (b) require that the stock certificates evidencing shares of Restricted Stock be held in custody by adesignated escrow agent (which may but need not be the Company) until the restrictions thereon shall have lapsed, and that theHolder deliver a stock power, endorsed in blank, relating to such Restricted Stock.7.6Section 83(b) Election. If a Holder makes an election under Section 83(b) of the Code to be taxedwith respect to the Restricted Stock as of the date of transfer of the Restricted Stock rather than as of the date or dates upon whichthe Holder would otherwise be taxable under Section 83(a) of the Code, the Holder shall be required to deliver a copy of suchelection to the Company promptly after filing such election with the Internal Revenue Service along with proof of the timely filingthereof with the Internal Revenue Service.ARTICLE 8.AWARD OF RESTRICTED STOCK UNITS8.1Grant of Restricted Stock Units. The Administrator is authorized to grant Awards of Restricted StockUnits to any Eligible Individual selected by the Administrator in such amounts and subject to such terms and conditions asdetermined by the Administrator.8.2Purchase Price. The Administrator shall specify the purchase price, if any, to be paid by the Holder tothe Company with respect to any Restricted Stock Unit award; provided, however, that value of the consideration shall not be lessthan the par value of a Share, unless otherwise permitted by Applicable Law.8.3Vesting of Restricted Stock Units. At the time of grant, the Administrator shall specify the date ordates on which the Restricted Stock Units shall become fully vested and nonforfeitable, and may specify such conditions to vestingas it deems appropriate, including, without limitation, vesting based upon the Holder’s duration of service to the Company or anySubsidiary, Company performance, individual performance or other specific criteria, in each case on a specified date or dates or overany period or periods, as determined by the Administrator. Without limiting the foregoing, the vesting period shall be at least one (1)year after the date of grant for Employees. 8.4Maturity and Payment. At the time of grant, the Administrator shall specify the maturity dateapplicable to each grant of Restricted Stock Units, which shall be no earlier than the vesting date or dates of the Award and may bedetermined at the election of the Holder (if permitted by the applicable Award Agreement); provided that, except as otherwisedetermined by the Administrator, set forth in any applicable Award Agreement, and subject to compliance14 with Section 409A of the Code, in no event shall the maturity date relating to each Restricted Stock Unit occur following the later of(a) the 15th day of the third month following the end of calendar year in which the applicable portion of the Restricted Stock Unitvests; or (b) the 15th day of the third month following the end of the Company’s fiscal year in which the applicable portion of theRestricted Stock Unit vests. On the maturity date, the Company shall, subject to Section 11.4(e), transfer to the Holder oneunrestricted, fully transferable Share for each Restricted Stock Unit scheduled to be paid out on such date and not previouslyforfeited, or in the sole discretion of the Administrator, an amount in cash equal to the Fair Market Value of such Shares on thematurity date or a combination of cash and Common Stock as determined by the Administrator. Notwithstanding any provisions ofthis Agreement, any acceleration of vesting provisions in an employment agreement with respect to Restricted Stock Units willsupersede the provisions of this Plan and the related Award Agreement, unless the employment agreement specifically statesotherwise.8.5No Rights as a Stockholder. Unless otherwise determined by the Administrator, a Holder ofRestricted Stock Units shall possess no incidents of ownership with respect to the Shares represented by such Restricted StockUnits, unless and until such Shares are transferred to the Holder pursuant to the terms of this Plan and the applicable AwardAgreement.8.6Dividend Equivalents. Subject to Section 9.2, the Administrator, in its sole discretion, may providethat Dividend Equivalents shall be earned by a Holder of Restricted Stock Units based on dividends declared on the CommonStock, to be credited as of dividend payment dates during the period between the date an Award of Restricted Stock Units is grantedto a Holder and the maturity date of such Award.ARTICLE 9.AWARD OF PERFORMANCE AWARDS, DIVIDEND EQUIVALENTS, STOCK PAYMENTS9.1Performance Awards.(a)The Administrator is authorized to grant Performance Awards, including Awards ofPerformance Stock Units, to any Eligible Individual. The value of Performance Awards, including Performance Stock Units, may belinked to specific performance criteria determined by the Administrator on a specified date or dates or over any period or periods and insuch amounts as may be determined by the Administrator. Performance Awards, including Performance Stock Unit awards, may bepaid in cash, Shares, or a combination of cash and Shares, as determined by the Administrator.(b)Without limiting Section 9.1(a), the Administrator may grant Performance Awards toany Eligible Individual in the form of a cash bonus payable upon the attainment of objective Performance Goals, or such other criteria,whether or not objective, which are established by the Administrator, in each case on a specified date or dates or over any period orperiods determined by the Administrator.9.2Dividend Equivalents. Dividend Equivalents may be granted by the Administrator based ondividends declared on the Common Stock, to be credited as of dividend15 payment dates with respect to dividends with record dates that occur during the period between the date an Award is granted to aHolder and the date such Award vests, is exercised, is distributed or expires, as determined by the Administrator. Such DividendEquivalents shall be converted to cash or additional Shares by such formula and at such time and subject to such restrictions andlimitations as may be determined by the Administrator.9.3Stock Payments. The Administrator is authorized to make Stock Payments to any Eligible Individual.The number or value of Shares of any Stock Payment shall be determined by the Administrator and may be based upon one or morespecific performance criteria, including service to the Company or any Subsidiary, determined by the Administrator. Sharesunderlying a Stock Payment which is subject to a vesting schedule or other conditions or criteria set by the Administrator shall notbe issued until those conditions have been satisfied. Unless otherwise provided by the Administrator, a Holder of a Stock Paymentshall have no rights as a Company stockholder with respect to such Stock Payment until such time as the Stock Payment has vestedand the Shares underlying the Award have been issued to the Holder. Stock Payments may, but are not required to, be made in lieuof base salary, bonus, fees or other cash compensation otherwise payable to such Eligible Individual.9.4Term. The term of a Performance Award, Dividend Equivalent award, and/or Stock Payment awardshall be established by the Administrator in its sole discretion.9.5Purchase Price. The Administrator may establish the purchase price of a Performance Award orShares distributed as a Stock Payment award; provided, however, that value of the consideration shall not be less than the par valueof a Share, unless otherwise permitted by Applicable Law.9.6Termination of Service. A Performance Award, Dividend Equivalent award, and/or Stock Paymentaward is distributable only while the Holder is an Employee, Director or Consultant, as applicable. The Administrator, however, inits sole discretion, may provide that the Performance Award, Dividend Equivalent award, and/or Stock Payment award may bedistributed subsequent to the Holder’s Termination of Service subject to terms and conditions determined by the Administrator.ARTICLE 10.AWARD OF STOCK APPRECIATION RIGHTS10.1Grant of Stock Appreciation Rights.(a)The Administrator is authorized to grant Stock Appreciation Rights to EligibleIndividuals from time to time, in its sole discretion, on such terms and conditions as it may determine, which shall not be inconsistentwith the Plan.(b)A Stock Appreciation Right shall entitle the Holder (or other person entitled to exercisethe Stock Appreciation Right pursuant to the Plan) to exercise all or a specified portion of the Stock Appreciation Right (to the extentthen exercisable pursuant to its terms) and to receive from the Company an amount determined by multiplying the difference obtainedby subtracting the exercise price per share of the Stock Appreciation Right from the Fair Market Value on the date of exercise of theStock Appreciation Right by the number of16 Shares with respect to which the Stock Appreciation Right shall have been exercised, subject to any limitations the Administrator mayimpose. Except as described in (c) below, the exercise price per Share subject to each Stock Appreciation Right shall be set by theAdministrator, but shall not be less than 100% of the Fair Market Value on the date the Stock Appreciation Right is granted.(c)Notwithstanding the foregoing provisions of Section 10.1(b) to the contrary, in the caseof a Stock Appreciation Right that is a Substitute Award, the exercise price per share of the Shares subject to such Stock AppreciationRight may be less than 100% of the Fair Market Value per share on the date of grant; provided that the excess of: (i) the aggregate FairMarket Value (as of the date such Substitute Award is granted) of the Shares subject to the Substitute Award, over (ii) the aggregateexercise price thereof does not exceed the excess of: (x) the aggregate fair market value (as of the time immediately preceding thetransaction giving rise to the Substitute Award, such fair market value to be determined by the Administrator) of the shares of thepredecessor entity that were subject to the grant assumed or substituted for by the Company, over (y) the aggregate exercise price ofsuch shares.10.2Stock Appreciation Right Vesting.(a)The period during which the right to exercise, in whole or in part, a Stock AppreciationRight vests in the Holder shall be set by the Administrator and the Administrator may determine that a Stock Appreciation Right maynot be exercised in whole or in part for a specified period after it is granted. Such vesting may be based on service with the Companyor any Subsidiary or any other criteria selected by the Administrator. Except as limited by the Plan, at any time after grant of a StockAppreciation Right, the Administrator, in its sole discretion and subject to whatever terms and conditions it selects, may accelerate theperiod during which a Stock Appreciation Right vests.(b)No portion of a Stock Appreciation Right which is unexercisable at a Holder’sTermination of Service shall thereafter become exercisable, except as may be otherwise provided by the Administrator in the applicableProgram, the Award Agreement evidencing the grant of a Stock Appreciation Right, or by action of the Administrator following thegrant of the Stock Appreciation Right.10.3Manner of Exercise. All or a portion of an exercisable Stock Appreciation Right shall be deemedexercised upon delivery of all of the following to the Secretary of the Company, the stock plan administrator of the Company, orsuch other person or entity designated by the Administrator, or his, her or its office, as applicable:(a)A written or electronic notice complying with the applicable rules established by theAdministrator stating that the Stock Appreciation Right, or a portion thereof, is exercised. The notice shall be signed by the Holder orother person then entitled to exercise the Stock Appreciation Right or such portion of the Stock Appreciation Right;(b)Such representations and documents as the Administrator, in its sole discretion, deemsnecessary or advisable to effect compliance with Applicable Law. The Administrator, in its sole discretion, may also take whateveradditional actions it deems17 appropriate to effect such compliance, including, without limitation, placing legends on share certificates and issuing stop-transfernotices to agents and registrars;(c)In the event that the Stock Appreciation Right shall be exercised pursuant to this Section10.3 by any person or persons other than the Holder, appropriate proof of the right of such person or persons to exercise the StockAppreciation Right, as determined in the sole discretion of the Administrator; and(d)Full payment of the exercise price (if any) and applicable withholding taxes to the stockplan administrator of the Company for the Shares with respect to which the Stock Appreciation Right, or portion thereof, is exercised,in a manner permitted by Sections 11.1 and 11.2.10.4Exercise following Termination of Service. Unless varied in an Award Agreement, the Holder shallhave ninety (90) days following a Termination of Service, other than for “cause” (as such term is defined in the sole discretion of theAdministrator, or as set forth in the Award Agreement relating to such Award) to exercise any vested portion of a StockAppreciation Right. All unvested portions of any Stock Appreciation Rights held shall automatically be forfeited upon aTermination of Service.10.5Stock Appreciation Right Term. The term of each Stock Appreciation Right (the “StockAppreciation Right Term”) shall be set by the Administrator in its sole discretion; provided, however, that the Stock AppreciationRight Term shall not be more than ten (10) years from the date the Stock Appreciation Right is granted. The Administrator shalldetermine the time period, including the time period following a Termination of Service, during which the Holder has the right toexercise the vested Stock Appreciation Rights, which time period may not extend beyond the last day of the Stock AppreciationRight Term applicable to such Stock Appreciation Right. Except as limited by the requirements of Section 409A of the Code andregulations and rulings thereunder or the first sentence of this Section 10.5, the Administrator may extend the Stock AppreciationRight Term of any outstanding Stock Appreciation Right, and may extend the time period during which vested Stock AppreciationRights may be exercised, in connection with any Termination of Service of the Holder, and may amend, subject to Section 13.1, anyother term or condition of such Stock Appreciation Right relating to such a Termination of Service.10.6Payment. Payment of the amounts payable with respect to Stock Appreciation Rights pursuant tothis Article 10 shall be in cash, Shares (based on its Fair Market Value as of the date the Stock Appreciation Right is exercised), or acombination of both, as determined by the Administrator.ARTICLE 11.ADDITIONAL TERMS OF AWARDS11.1Payment. The Administrator shall determine the methods by which payments by any Holder withrespect to any Awards granted under the Plan shall be made, including, without limitation: (a) cash or check, (b) Shares (including,in the case of payment of the exercise price of an Award, Shares issuable pursuant to the exercise of the Award) or Shares18 held for such period of time as may be required by the Administrator in order to avoid adverse accounting consequences, in eachcase, having a Fair Market Value on the date of delivery equal to the aggregate payments required, (c) delivery of a written orelectronic notice that the Holder has placed a market sell order with a broker acceptable to the Company with respect to Shares thenissuable upon exercise or vesting of an Award, and that the broker has been directed to pay a sufficient portion of the net proceedsof the sale to the Company in satisfaction of the aggregate payments required; provided that payment of such proceeds is then madeto the Company upon settlement of such sale, or (d) other form of legal consideration acceptable to the Administrator in its solediscretion. The Administrator shall also determine the methods by which Shares shall be delivered or deemed to be delivered toHolders. Notwithstanding any other provision of the Plan to the contrary, no Holder who is a Director or an “executive officer” ofthe Company within the meaning of Section 13(k) of the Exchange Act shall be permitted to make payment with respect to anyAwards granted under the Plan, or continue any extension of credit with respect to such payment, with a loan from the Company ora loan arranged by the Company in violation of Section 13(k) of the Exchange Act.11.2Tax Withholding. The Company or any Subsidiary shall have the authority and the right to deductor withhold, or require a Holder to remit to the Company, an amount sufficient to satisfy federal, state, local and foreign taxes(including the Holder’s FICA, employment tax or other social security contribution obligation) required by law to be withheld withrespect to any taxable event concerning a Holder arising as a result of the Plan. The Administrator, in its sole discretion and insatisfaction of the foregoing requirement, may withhold, or allow a Holder to elect to have the Company withhold, Shares otherwiseissuable under an Award (or allow the surrender of Shares). The number of Shares which may be so withheld or surrendered shallbe limited to the number of Shares which have a Fair Market Value on the date of withholding or repurchase equal to the aggregateamount of such liabilities based on the applicable statutory withholding rates for federal, state, local and foreign income tax andpayroll tax purposes that are applicable to such supplemental taxable income without leading to any avoid adverse accountingconsequences. The Administrator shall determine the Fair Market Value of the Shares, consistent with applicable provisions of theCode, for tax withholding obligations due in connection with a broker-assisted cashless Option or Stock Appreciation Right exerciseinvolving the sale of Shares to pay the Option or Stock Appreciation Right exercise price or any tax withholding obligation.11.3Transferability of Awards.(a)Except as otherwise provided in Sections 11.3(b) and 11.3(c):(i)No Award under the Plan may be sold, pledged, assigned ortransferred in any manner other than by will or the laws of descent and distribution or, subject to the consent of the Administrator,pursuant to a DRO, unless and until such Award has been exercised, or the Shares underlying such Award have been issued, and allrestrictions applicable to such Shares have lapsed;(ii)No Award or interest or right therein shall be liable for the debts,contracts or engagements of the Holder or the Holder’s successors in interest or shall be subject19 to disposition by transfer, alienation, anticipation, pledge, hypothecation, encumbrance, assignment or any other means whether suchdisposition be voluntary or involuntary or by operation of law by judgment, levy, attachment, garnishment or any other legal orequitable proceedings (including bankruptcy), and any attempted disposition thereof shall be null and void and of no effect, except tothe extent that such disposition is permitted by Section 11.3(a)(i); and(iii)During the lifetime of the Holder, only the Holder may exercise anAward (or any portion thereof) granted to such Holder under the Plan, unless it has been disposed of pursuant to a DRO; after thedeath of the Holder, any exercisable portion of an Award may, prior to the time when such portion becomes unexercisable under thePlan or the applicable Program or Award Agreement, be exercised by the Holder’s personal representative or by any personempowered to do so under the deceased Holder’s will or under the then-applicable laws of descent and distribution.(b)Notwithstanding Section 11.3(a), the Administrator, in its sole discretion, may determineto permit a Holder to transfer an Award other than an Incentive Stock Option to any one or more Permitted Transferees, subject to thefollowing terms and conditions: (i) an Award transferred to a Permitted Transferee without the consent of the Administrator shall notbe assignable or transferable by the Permitted Transferee other than by will or the laws of descent and distribution or pursuant to aDRO; (ii) an Award transferred to a Permitted Transferee shall continue to be subject to all the terms and conditions of the Award asapplicable to the original Holder (other than the ability to further transfer the Award); and (iii) the Holder and the Permitted Transfereeshall execute any and all documents requested by the Administrator, including, without limitation documents to (A) confirm the statusof the transferee as a Permitted Transferee, (B) satisfy any requirements for an exemption for the transfer under Applicable Law and(C) evidence the transfer.(c)Notwithstanding Section 11.3(a), a Holder may, in the manner determined by theAdministrator, designate a beneficiary to exercise the rights of the Holder and to receive any distribution with respect to any Awardupon the Holder’s death. A beneficiary, legal guardian, legal representative, or other person claiming any rights pursuant to the Plan issubject to all terms and conditions of the Plan and any Program or Award Agreement applicable to the Holder, except to the extent thePlan, any Program or any Award Agreement otherwise provides, and to any additional restrictions deemed necessary or appropriate bythe Administrator. If the Holder is married or a domestic partner in a domestic partnership qualified under Applicable Law and residesin a community property state, a designation of a person other than the Holder’s spouse or domestic partner, as applicable, as theHolder’s beneficiary with respect to more than 50% of the Holder’s interest in the Award shall not be effective without the priorwritten or electronic consent of the Holder’s spouse or domestic partner. If no beneficiary has been designated or survives the Holder,payment shall be made to the person entitled thereto pursuant to the Holder’s will or the laws of descent and distribution. Subject to theforegoing, a beneficiary designation may be changed or revoked by a Holder at any time; provided that the change or revocation isfiled with the Administrator prior to the Holder’s death.20 11.4Conditions to Issuance of Shares.(a)Notwithstanding anything herein to the contrary, the Company shall not be required toissue or deliver any certificates or make any book entries evidencing Shares pursuant to the exercise of any Award, unless and until theBoard or the Committee has determined, with advice of counsel, that the issuance of such Shares is in compliance with ApplicableLaw and the Shares are covered by an effective registration statement or applicable exemption from registration. In addition to theterms and conditions provided herein, the Board or the Committee may require that a Holder make such reasonable covenants,agreements and representations as the Board or the Committee, in its sole discretion, deems advisable in order to comply withApplicable Law.(b)All share certificates delivered pursuant to the Plan and all Shares issued pursuant tobook entry procedures may be subject to any stop-transfer orders and other restrictions as the Administrator deems necessary oradvisable to comply with Applicable Law. The Administrator may place legends on any share certificate or book entry to referencerestrictions applicable to the Shares.(c)The Administrator shall have the right to require any Holder to comply with any timingor other restrictions with respect to the settlement, distribution or exercise of any Award, including a window-period limitation, as maybe imposed in the sole discretion of the Administrator.(d)No fractional Shares shall be issued and the Administrator, in its sole discretion, shalldetermine whether cash shall be given in lieu of fractional Shares or whether such fractional Shares shall be eliminated by roundingdown.(e)Notwithstanding any other provision of the Plan, unless otherwise determined by theAdministrator or required by Applicable Law, the Company shall not deliver to any Holder certificates evidencing Shares issued inconnection with any Award and instead such Shares shall be recorded in the books of the Company (or, as applicable, its transfer agentor stock plan administrator).11.5Forfeiture and Claw-Back Provisions. Pursuant to its general authority to determine the terms andconditions applicable to Awards under the Plan, the Administrator shall have the right to provide, in an Award Agreement orotherwise, or to require a Holder to agree by separate written or electronic instrument, that:(a)(i) Any proceeds, gains or other economic benefit actually or constructively received bythe Holder upon any receipt or exercise of the Award, or upon the receipt or resale of any Shares underlying the Award, shall be paidto the Company, and (ii) the Award shall terminate and any unexercised portion of the Award (whether or not vested) shall beforfeited, if (x) a Termination of Service occurs prior to a specified date, or within a specified time period following receipt or exerciseof the Award, or (y) the Holder at any time, or during a specified time period, engages in any activity in competition with theCompany, or which is inimical, contrary or harmful to the interests of the Company, as further defined by the Administrator or (z) theHolder incurs a Termination of Service for “cause” (as such term is21 defined in the sole discretion of the Administrator, or as set forth in the Award Agreement relating to such Award); and(b)All Awards (including any proceeds, gains or other economic benefit actually orconstructively received by the Holder upon any receipt or exercise of any Award or upon the receipt or resale of any Shares underlyingthe Award) shall be subject to the provisions of any claw-back policy implemented by the Company, including, without limitation, anyclaw-back policy adopted to comply with the requirements of Applicable Law, including without limitation the Dodd-Frank WallStreet Reform and Consumer Protection Act and any rules or regulations promulgated thereunder, to the extent set forth in such claw-back policy and/or in the applicable Award Agreement.ARTICLE 12.ADMINISTRATION12.1Administrator. The Compensation Committee of the Board (or another committee or a subcommitteeof the Board or the Compensation Committee of the Board assuming the functions of the Committee under the Plan) shall administerthe Plan (except as otherwise permitted herein). To the extent necessary to comply with Rule 16b-3 of the Exchange Act, theCompensation Committee of the Board (or another committee or subcommittee of the Board or the Compensation Committee of theBoard assuming the functions of the Committee under the Plan) shall take all action with respect to such Awards, and the individualstaking such action shall consist solely of two or more Non-Employee Directors appointed by and holding office at the pleasure ofthe Board, each of whom is intended to qualify as a “non-employee director” as defined by Rule 16b-3 of the Exchange Act or anysuccessor rule. Additionally, to the extent required by Applicable Law, each of the individuals constituting the CompensationCommittee of the Board (or another committee or subcommittee of the Board or the Compensation Committee of the Boardassuming the functions of the Committee under the Plan) shall be an “independent director” under the rules of any securitiesexchange or automated quotation system on which the Shares are listed, quoted or traded. Notwithstanding the foregoing, any actiontaken by the Committee shall be valid and effective, whether or not members of the Committee at the time of such action are laterdetermined not to have satisfied the requirements for membership set forth in this Section 12.1 or otherwise provided in any charterof the Committee. Except as may otherwise be provided in any charter of the Committee, appointment of Committee members shallbe effective upon acceptance of appointment. Committee members may resign at any time by delivering written or electronic noticeto the Board. Vacancies in the Committee may only be filled by the Board. Notwithstanding the foregoing, (a) the full Board, actingby a majority of its members in office, shall conduct the general administration of the Plan with respect to Awards granted to Non-Employee Directors and, with respect to such Awards, the terms “Administrator” and “Committee” as used in the Plan shall bedeemed to refer to the Board and (b) the Board or Committee may delegate its authority hereunder to the extent permitted by Section12.6.12.2Duties and Powers of Committee. It shall be the duty of the Committee to conduct the generaladministration of the Plan in accordance with its provisions. The Committee has the power to interpret the Plan, the Programs andthe Award Agreements, and22 to adopt such rules for the administration, interpretation and application of the Plan as are not inconsistent therewith, to interpret,amend or revoke any such rules and to amend any Program or Award Agreement; provided that the rights or obligations of theHolder of the Award that is the subject of any such Program or Award Agreement are not affected adversely by such amendment,unless the consent of the Holder is obtained or such amendment is otherwise permitted under Section 11.5 or Section 13.10. Anysuch grant or award under the Plan need not be the same with respect to each Holder. Any such interpretations and rules withrespect to Incentive Stock Options shall be consistent with the provisions of Section 422 of the Code. In its sole discretion, theBoard may at any time and from time to time exercise any and all rights and duties of the Committee under the Plan, except withrespect to matters which under Rule 16b‑3 under the Exchange Act or any successor rule, or the rules of any securities exchange orautomated quotation system on which the Shares are listed, quoted or traded, are required to be determined in the sole discretion ofthe Committee.12.3Action by the Committee. Unless otherwise established by the Board or in any charter of theCommittee, a majority of the Committee shall constitute a quorum and the acts of a majority of the members present at any meetingat which a quorum is present, and acts approved in writing by all members of the Committee in lieu of a meeting, shall be deemedthe acts of the Committee. Each member of the Committee is entitled to, in good faith, rely or act upon any report or otherinformation furnished to that member by any Employee, the Company’s independent certified public accountants, or any executivecompensation consultant or other professional retained by the Company to assist in the administration of the Plan.12.4Authority of Administrator. Subject to the Company’s Amended and Restated Bylaws, the charterof the Committee and any specific designation in the Plan, the Administrator has the exclusive power, authority and sole discretionto:(a)Designate Eligible Individuals to receive Awards;(b)Determine the type or types of Awards to be granted to each Eligible Individual;(c)Determine the number of Awards to be granted and the number of Shares to which anAward will relate;(d)Determine the terms and conditions of any Award granted pursuant to the Plan,including, but not limited to, the exercise price, grant price, purchase price, any restrictions or limitations on the Award, any schedulefor vesting, lapse of forfeiture restrictions or restrictions on the exercisability of an Award, and accelerations or waivers thereof, andany provisions related to non-competition and recapture of gain on an Award, based in each case on such considerations as theAdministrator in its sole discretion determines;(e)Determine whether, to what extent, and pursuant to what circumstances an Award maybe settled in, or the exercise price of an Award may be paid in cash, Shares, other Awards, or other property, or an Award may becanceled, forfeited, or surrendered;23 (f)Prescribe the form of each Award Agreement, which need not be identical for eachHolder;(g)Decide all other matters that must be determined in connection with an Award;(h)Establish, adopt, or revise any rules and regulations as it may deem necessary oradvisable to administer the Plan;(i)Interpret the terms of, and any matter arising pursuant to, the Plan, any Program or anyAward Agreement;(j)Make all other decisions and determinations that may be required pursuant to the Plan oras the Administrator deems necessary or advisable to administer the Plan; and(k)Accelerate wholly or partially the vesting or lapse of restrictions of any Award orportion thereof at any time after the grant of an Award, subject to whatever terms and conditions it selects and Section 13.2.12.5Decisions Binding. The Administrator’s interpretation of the Plan, any Awards granted pursuant tothe Plan, any Program, any Award Agreement and all decisions and determinations by the Administrator with respect to the Plan arefinal, binding and conclusive on all parties.12.6Delegation of Authority. To the extent permitted by Applicable Law, the Board or Committee mayfrom time to time delegate to a committee of one or more members of the Board or one or more officers of the Company theauthority to grant or amend Awards or to take other administrative actions pursuant to this Article 12; provided, however, that in noevent shall an officer of the Company be delegated the authority to grant awards to, or amend awards held by, the followingindividuals: (a) individuals who are subject to Section 16 of the Exchange Act or (b) officers of the Company (or Directors) towhom authority to grant or amend Awards has been delegated hereunder; provided, further, that any delegation of administrativeauthority shall only be permitted to the extent it is permissible under Applicable Law. Any delegation hereunder shall be subject tothe restrictions and limits that the Board or Committee specifies at the time of such delegation, and the Board may at any timerescind the authority so delegated or appoint a new delegatee. At all times, the delegatee appointed under this Section 12.6 shallserve in such capacity at the pleasure of the Board and the Committee (to the extent the Committee delegated its authority to thedelegatee).ARTICLE 13.MISCELLANEOUS PROVISIONS13.1Amendment, Suspension or Termination of the Plan. Except as otherwise provided in this Section13.1, the Plan may be wholly or partially amended or otherwise modified, suspended or terminated at any time or from time to timeby the Board or the Committee. However, without approval of the Company’s stockholders given within twelve (12) months beforeor after the action by the Administrator, no action of the Administrator may, except as provided in Section 13.2, increase the limitsimposed in Section 3.1 on the24 maximum number of Shares which may be issued under the Plan, or otherwise amend or modify the Plan in a manner requiringstockholder approval under Applicable Law. Except as provided in Section 11.5 and Section 13.10, no amendment, suspension ortermination of the Plan shall, without the consent of the Holder, materially impair any rights or obligations under any Awardtheretofore granted or awarded, unless the Award itself otherwise expressly so provides. No Awards may be granted or awardedduring any period of suspension or after termination of the Plan, and notwithstanding anything herein to the contrary, in no eventmay any Award be granted under the Plan after the tenth (10th) anniversary of the date the Plan is first adopted by the Board (the“Expiration Date”). Any Awards that are outstanding on the Expiration Date shall remain in force according to the terms of the Planand the applicable Award Agreement.13.2Changes in Common Stock or Assets of the Company, Acquisition or Liquidation of the Companyand Other Corporate Events.(a)In the event of any stock dividend, stock split, combination or exchange of shares,merger, consolidation or other distribution (other than normal cash dividends) of Company assets to stockholders, or any other changeaffecting the Shares of the Company’s stock or the share price of the Company’s stock other than an Equity Restructuring, theAdministrator shall make equitable adjustments, if any, to reflect such change with respect to: (i) the aggregate number and kind ofShares that may be issued under the Plan (including, but not limited to, adjustments of the limitations in Section 3.1 on the maximumnumber and kind of Shares which may be issued under the Plan); (ii) the number and kind of Shares (or other securities or property)subject to outstanding Awards; (iii) the terms and conditions of any outstanding Awards (including, without limitation, any applicableperformance targets or criteria with respect thereto); and (v) the grant or exercise price per share for any outstanding Awards under thePlan.(b)In the event of any transaction or event described in Section 13.2(a) or any unusual ornonrecurring transactions or events affecting the Company, any Subsidiary of the Company, or the financial statements of theCompany or any Subsidiary, or of changes in Applicable Law or accounting principles, the Administrator, in its sole discretion, and onsuch terms and conditions as it deems appropriate, either by the terms of the Award or by action taken prior to the occurrence of suchtransaction or event and either automatically or upon the Holder’s request, is hereby authorized to take any one or more of thefollowing actions whenever the Administrator determines that such action is appropriate in order to prevent dilution or enlargement ofthe benefits or potential benefits intended to be made available under the Plan or with respect to any Award under the Plan, to facilitatesuch transactions or events or to give effect to such changes in laws, regulations or principles:(i)To provide for either (A) termination of any such Award in exchangefor an amount of cash, if any, equal to the amount that would have been attained upon the exercise of such Award or realization of theHolder’s rights (and, for the avoidance of doubt, if as of the date of the occurrence of the transaction or event described in this Section13.2 the Administrator determines in good faith that no amount would have been attained upon the exercise of such Award orrealization of the Holder’s rights, then such Award may be terminated by the Company without payment) or (B) the replacement ofsuch Award with other rights or25 property selected by the Administrator, in its sole discretion, having an aggregate value not exceeding the amount that could have beenattained upon the exercise of such Award or realization of the Holder’s rights had such Award been currently exercisable or payable orfully vested;(ii)To provide that such Award be assumed by the successor or survivorcorporation, or a parent or subsidiary thereof, or shall be substituted for by similar options, rights or awards covering the stock of thesuccessor or survivor corporation, or a parent or subsidiary thereof, with appropriate adjustments as to the number and kind of sharesand prices;(iii)To make adjustments in the number and type of Shares of theCompany’s stock (or other securities or property) subject to outstanding Awards, and in the number and kind of outstanding RestrictedStock and/or in the terms and conditions of (including the grant or exercise price), and the criteria included in, outstanding Awards andAwards which may be granted in the future;(iv)To provide that such Award shall be exercisable or payable or fullyvested with respect to all Shares covered thereby, notwithstanding anything to the contrary in the Plan or the applicable Program orAward Agreement; and(v)To provide that the Award cannot vest, be exercised or becomepayable after such event.(c)In connection with the occurrence of any Equity Restructuring, and notwithstandinganything to the contrary in Sections 13.2(a) and 13.2(b), the Administrator shall equitably adjust each outstanding Award, whichadjustments may include adjustments to the number and type of securities subject to each outstanding Award and/or the exercise priceor grant price thereof, if applicable, the grant of new Awards, and/or the making of a cash payment. The Administrator shall make suchequitable adjustments, if any, as the Administrator, in its sole discretion, may deem appropriate to reflect such Equity Restructuringwith respect to the aggregate number and kind of Shares that may be issued under the Plan (including, but not limited to, adjustmentsof the limitations in Section 3.1 on the maximum number and kind of Shares which may be issued under the Plan). The adjustmentsprovided under this Section 13.2(c) shall be nondiscretionary and shall be final and binding on the affected Holder and the Company.(d)Notwithstanding any other provision of the Plan, in the event of a Change in Control,unless the Administrator elects to (i) terminate an Award in exchange for cash, rights or property, or (ii) cause an Award to becomefully exercisable and no longer subject to any forfeiture restrictions prior to the consummation of a Change in Control, pursuant toSection 13.2, (A) such Award (other than any portion subject to performance-based vesting) shall continue in effect or be assumed oran equivalent Award substituted by the successor corporation or a parent or subsidiary of the successor corporation and (B) the portionof such Award subject to performance-based vesting shall be subject to the terms and conditions of the applicable Award Agreementand, in the absence of applicable terms and conditions, the Administrator’s discretion.26 (e)In the event that the successor corporation in a Change in Control refuses to assume orsubstitute for an Award (other than any portion subject to performance-based vesting), the Administrator may cause any or all of suchAward (or portion thereof) to (i) terminate in exchange for cash, rights or other property pursuant to Section 13.2(b)(i) or (ii) becomefully exercisable immediately prior to the consummation of such transaction and all forfeiture restrictions on any or all of such Awardto lapse. If any such Award is exercisable in lieu of assumption or substitution in the event of a Change in Control, the Administratorshall notify the Holder that such Award shall be fully exercisable for a period of fifteen (15) days from the date of such notice,contingent upon the occurrence of the Change in Control, and such Award shall terminate upon the expiration of such period.(f)The Administrator, in its sole discretion, may include such further provisions andlimitations in any Award, agreement or certificate, as it may deem equitable and in the best interests of the Company that are notinconsistent with the provisions of the Plan.(g)No adjustment or action described in this Section 13.2 or in any other provision of thePlan shall be authorized to the extent that such adjustment or action would cause the Plan to violate Section 422(b)(1) of the Code.Furthermore, no such adjustment or action shall be authorized to the extent such adjustment or action would result in short-swingprofits liability under Section 16 or violate the exemptive conditions of Rule 16b-3 unless the Administrator determines that the Awardis not to comply with such exemptive conditions.(h)The existence of the Plan, a Program, an Award Agreement and the Awards grantedhereunder shall not affect or restrict in any way the right or power of the Company or the stockholders of the Company to make orauthorize any adjustment, recapitalization, reorganization or other change in the Company’s capital structure or its business, any mergeror consolidation of the Company, any issue of stock or of options, warrants or rights to purchase stock or of bonds, debentures,preferred or prior preference stocks whose rights are superior to or affect the Common Stock or the rights thereof or which areconvertible into or exchangeable for Common Stock, or the dissolution or liquidation of the Company, or any sale or transfer of all orany part of its assets or business, or any other corporate act or proceeding, whether of a similar character or otherwise.(i)No action shall be taken under this Section 13.2 which shall cause an Award to fail to beexempt from or comply with Section 409A of the Code or the Treasury Regulations thereunder.(j)In the event of any pending stock dividend, stock split, combination or exchange ofshares, merger, consolidation or other distribution (other than normal cash dividends) of Company assets to stockholders, or any otherextraordinary transaction or change affecting the Shares or the share price of the Common Stock including any Equity Restructuring,for reasons of administrative convenience, the Company, in its sole discretion, may refuse to permit the exercise of any Award during aperiod of up to sixty (60) days prior to the consummation of any such transaction.27 13.3Approval of Plan by Stockholders. The Plan shall be submitted for the approval of the Company’sstockholders within twelve (12) months after the date of the Board’s initial adoption of the Plan.13.4No Stockholders Rights. Except as otherwise provided herein, a Holder shall have none of the rightsof a stockholder with respect to Shares covered by any Award until the Holder becomes the record owner of such Shares.13.5Paperless Administration. In the event that the Company establishes, for itself or using the servicesof a third party, an automated system for the documentation, granting or exercise of Awards, such as a system using an internetwebsite or interactive voice response, then the paperless documentation, granting or exercise of Awards by a Holder may bepermitted through the use of such an automated system.13.6Effect of Plan upon Other Compensation Plans. The adoption of the Plan shall not affect any othercompensation or incentive plans in effect for the Company or any Subsidiary. Nothing in the Plan shall be construed to limit theright of the Company or any Subsidiary: (a) to establish any other forms of incentives or compensation for Employees, Directors orConsultants of the Company or any Subsidiary, or (b) to grant or assume options or other rights or awards otherwise than under thePlan in connection with any proper corporate purpose including without limitation, the grant or assumption of options in connectionwith the acquisition by purchase, lease, merger, consolidation or otherwise, of the business, stock or assets of any corporation,partnership, limited liability company, firm or association.13.7Compliance with Laws. The Plan, the granting and vesting of Awards under the Plan and theissuance and delivery of Shares and the payment of money under the Plan or under Awards granted or awarded under the Plan aresubject to compliance with all Applicable Law (including but not limited to state, federal and foreign securities law and marginrequirements), and to such approvals by any listing, regulatory or governmental authority as may, in the opinion of counsel for theCompany, be necessary or advisable in connection therewith. Any securities delivered under the Plan shall be subject to suchrestrictions, and the person acquiring such securities shall, if requested by the Company, provide such assurances and representationsto the Company as the Company may deem necessary or desirable to assure compliance with all Applicable Law. To the extentpermitted by Applicable Law, the Plan and Awards granted or awarded hereunder shall be deemed amended to the extent necessaryto conform to Applicable Law.13.8Titles and Headings, References to Sections of the Code or Exchange Act. The titles and headingsof the Sections in the Plan are for convenience of reference only and, in the event of any conflict, the text of the Plan, rather thansuch titles or headings, shall control. References to sections of the Code or the Exchange Act shall include any amendment orsuccessor thereto.13.9Governing Law. The Plan and any agreements hereunder shall be administered, interpreted andenforced under the internal laws of the State of Delaware without regard to conflicts of laws thereof or of any other jurisdiction.28 13.10Section 409A. To the extent that the Administrator determines that any Award granted under thePlan is subject to Section 409A of the Code, the Program pursuant to which such Award is granted and the Award Agreementevidencing such Award shall incorporate the terms and conditions required by Section 409A of the Code. To the extent applicable,the Plan, the Program and any Award Agreements shall be interpreted in accordance with Section 409A of the Code andDepartment of Treasury regulations and other interpretive guidance issued thereunder, including without limitation any suchregulations or other guidance that may be issued after the Effective Date. Notwithstanding any provision of the Plan to the contrary,in the event that following the Effective Date the Administrator determines that any Award may be subject to Section 409A of theCode and related Department of Treasury guidance (including such Department of Treasury guidance as may be issued after theEffective Date), the Administrator may adopt such amendments to the Plan and the applicable Program and Award Agreement oradopt other policies and procedures (including amendments, policies and procedures with retroactive effect), or take any otheractions, that the Administrator determines are necessary or appropriate to (a) exempt the Award from Section 409A of the Codeand/or preserve the intended tax treatment of the benefits provided with respect to the Award, or (b) comply with the requirements ofSection 409A of the Code and related Department of Treasury guidance and thereby avoid the application of any penalty taxesunder such Section.13.11No Right to Awards. No Eligible Individual or other person shall have any claim to be granted anyAward pursuant to the Plan, and neither the Company nor the Administrator is obligated to treat Eligible Individuals, Holders or anyother persons uniformly.13.12Unfunded Status of Awards. The Plan is intended to be an “unfunded” plan for incentivecompensation. With respect to any payments not yet made to a Holder pursuant to an Award, nothing contained in the Plan or anyProgram or Award Agreement shall give the Holder any rights that are greater than those of a general creditor of the Company orany Subsidiary.13.13Indemnification. To the extent allowable pursuant to Applicable Law, each member of theCommittee or of the Board shall be indemnified and held harmless by the Company from any loss, cost, liability, or expense thatmay be imposed upon or reasonably incurred by such member in connection with or resulting from any claim, action, suit, orproceeding to which he or she may be a party or in which he or she may be involved by reason of any action or failure to actpursuant to the Plan and against and from any and all amounts paid by him or her in satisfaction of judgment in such action, suit, orproceeding against him or her; provided he or she gives the Company an opportunity, at its own expense, to handle and defend thesame before he or she undertakes to handle and defend it on his or her own behalf. The foregoing right of indemnification shall notbe exclusive of any other rights of indemnification to which such persons may be entitled pursuant to the Company’s Amended andRestated Bylaws, as a matter of law, or otherwise, or any power that the Company may have to indemnify them or hold themharmless.13.14Relationship to other Benefits. No payment pursuant to the Plan shall be taken into account indetermining any benefits under any pension, retirement, savings, profit sharing,29 group insurance, welfare or other benefit plan of the Company or any Subsidiary except to the extent otherwise expressly providedin writing in such other plan or an agreement thereunder.13.15Expenses. The expenses of administering the Plan shall be borne by the Company and itsSubsidiaries. 30Exhibit 10.9.1Employee/Consultant Stock Option Award AgreementGranted Under OpGen, Inc. 2015 Equity Incentive Plan 1.Grant of Option. This certificate evidences a stock option (this “Stock Option”) granted by OpGen, Inc., a Delawarecorporation (the “Company”), on ________________ (the “Grant Date”), to ___________________ (the “Participant”), pursuant tothe Company’s 2015 Equity Incentive Plan (as from time to time in effect, the “Plan”). Under this Stock Option, the Participant maypurchase, in whole or in part, on the terms herein provided, a total of ______________ (_______) shares of common stock of theCompany (the “Shares”) at $_____ per Share, which is equal to the fair market value of the Shares on the Grant Date. The latest dateon which this Stock Option, or any part thereof, may be exercised is ___________ (the “Final Exercise Date”). The Stock Optionevidenced by this certificate is intended to be, and is hereby designated, as an incentive stock option as defined in section 422 of theInternal Revenue Code of 1986, as amended from time to time (the “Code”), to the extent permitted by section 422 of the Code, and anonstatutory option, that is, an option that does not qualify as an incentive stock option as defined in section 422 of the Code for theremainder. Defined terms used in this Award Agreement without definition have the meanings set forth in the Plan.This Stock Option is exercisable in the following installments prior to the Final Exercise Date: twenty‑five percent (25%) of the sharesunderlying this Stock Option on the first anniversary of the Grant Date (the “Vesting Commencement Date”), and six and one-quarterpercent (6.25%) at the end of each quarterly period thereafter. 2.Exercise of Stock Option. (a)Each election to exercise this Stock Option shall be in writing, signed by the Participant or the Participant’sexecutor, administrator, or legally appointed representative (in the event of the Participant’s incapacity) or the person or persons towhom this Stock Option is transferred by will or the applicable laws of descent and distribution (collectively, the “Option Holder”), andreceived by the Company at its principal office, accompanied by this certificate and payment in full as provided in the Plan. Subject tothe further terms and conditions provided in the Plan, the purchase price may be paid as follows: (i) cash or check, (ii) Shares(including, in the case of payment of the exercise price of an Award, Shares issuable pursuant to the exercise of the Award) or Sharesheld for such period of time as may be required by the Administrator in order to avoid adverse accounting consequences, in each case,having a Fair Market Value on the date of delivery equal to the aggregate payments required, (iii) delivery of a written or electronicnotice that the Option Holder has placed a market sell order with a broker acceptable to the Company with respect to Shares thenissuable upon exercise or vesting of an Award, and that the broker has been directed to pay a sufficient portion of the net proceeds ofthe sale to the Company in satisfaction of the aggregate payments required; provided that payment of such proceeds is then made to theCompany upon settlement of such sale. In the event that this Stock Option is exercised by an Option Holder other than the Participant,the Company will be under no obligation to deliver Shares hereunder unless and until it is satisfied as to the authority of the OptionHolder to exercise this Stock Option.(b)The provisions of Section 5.4(b) of the Plan apply with respect to the term of the Award following a Terminationof Service. Without limiting the foregoing, if the Participant has a Termination  of Service for reasons other than death or disability prior to the expiration of this Stock Option Award, unless varied by theAdministrator in advance of the Termination of Service date, any unvested portion of this Award shall be forfeited and the Participantshall have ninety (90) days to exercise the vested portion of this Award. Any such exercise shall be transacted in accordance with thisAgreement and the Plan. 3.Notice of Disposition. The person exercising this Stock Option shall notify the Company when making any disposition of theShares acquired upon exercise of this Stock Option, whether by sale, gift or otherwise.4.Restrictions on Transfer of Shares. If at the time this Stock Option is exercised, the Company and any of its stockholders is aparty to any agreement restricting the transfer of any outstanding shares of the Company’s common stock, the Administrator mayprovide that this Stock Option may be exercised only if the Shares so acquired are made subject to the transfer restrictions set forth inthat agreement (or if more than one such agreement is then in effect, the agreement or agreements specified by the Administrator).5.Withholding; Agreement to Provide Security. If at the time this Stock Option is exercised the Company determines thatunder applicable law and regulations it could be liable for the withholding of any federal or state tax upon exercise or with respect to adisposition of any Shares acquired upon exercise of this Stock Option, this Stock Option may not be exercised unless the personexercising this Stock Option remits to the Company any amounts determined by the Company to be required to be withheld uponexercise (or makes other arrangements satisfactory to the Company for the payment of such taxes) and gives such security as theCompany deems adequate to meet its potential liability for the withholding of tax upon a disposition of the Shares and agrees toaugment such security from time to time in any amount reasonably determined by the Company to be necessary to preserve theadequacy of such security.6.Nontransferability of Stock Option. This Stock Option is not transferable by the Participant otherwise than by will or thelaws of descent and distribution and is exercisable during the Participant’s lifetime only by the Participant (or in the event of theParticipant’s incapacity, the person or persons legally appointed to act on the Participant’s behalf). 7.Provisions of the Plan. This Stock Option is subject to the provisions of the Plan, which are incorporated herein byreference. A copy of the Plan as in effect on the date of the grant of this Stock Option has been furnished to the Participant. Byexercising all or any part of this Stock Option, the Participant agrees to be bound by the terms of the Plan and this certificate. Allinitially capitalized terms used herein will have the meaning specified in the Plan, unless another meaning is specified herein. [The remainder of this page is intentionally left blank]2  IN WITNESS WHEREOF, the Company has caused this instrument to be executed by its duly authorized officer. OpGen, Inc. Dated: _________________________________By: Title: Acknowledged and agreed:Participant Dated: _________________________________Name: [Stock Option Award Agreement Signature Page]Exhibit 10.9.2Non-Employee DirectorInitial Stock Option Award AgreementGranted Under OpGen, Inc. 2015 Equity Incentive Plan 1.Grant of Option. This certificate evidences a non-qualified stock option (this “Stock Option”) granted by OpGen, Inc., aDelaware corporation (the “Company”), on ___________ (the “Grant Date”), to ____________ (the “Participant”), pursuant to theCompany’s 2015 Equity Incentive Plan (as from time to time in effect, the “Plan”). Under this Stock Option, the Participant maypurchase, in whole or in part, on the terms herein provided, a total of thirty thousand (30,000) shares of common stock of theCompany (the “Shares”) at $_____ per Share, which is equal to the fair market value of the Shares on the Grant Date. The latest dateon which this Stock Option, or any part thereof, may be exercised is _________ [ten year anniversary of the Grant Date] (the “FinalExercise Date”). The Stock Option evidenced by this certificate is intended to be, and is hereby designated, as a nonstatutory option,that is, an option that does not qualify as an incentive stock option as defined in section 422 of the Internal Revenue Code of 1986, asamended from time to time (the “Code”). Defined terms used in this Award Agreement without definition have the meanings set forthin the Plan.This Stock Option is exercisable in the following installments prior to the Final Exercise Date: one-third of the Stock Option to acquire10,000 of the underlying Shares shall ratably vest and become exercisable on _________ [the first anniversary of the Grant Date] (the“Vesting Commencement Date”), and the remainder of the Stock Option shall ratably vest and become exercisable in one-thirdinstallments on __________ and ___________ [the second and third anniversaries of the Grant Date]. 2.Exercise of Stock Option. (a)Each election to exercise this Stock Option shall be in writing, signed by the Participant or the Participant’sexecutor, administrator, or legally appointed representative (in the event of the Participant’s incapacity) or the person or persons towhom this Stock Option is transferred by will or the applicable laws of descent and distribution (collectively, the “Option Holder”), andreceived by the Company at its principal office, accompanied by this certificate and payment in full as provided in the Plan. Subject tothe further terms and conditions provided in the Plan, the purchase price may be paid as follows: (i) cash or check, or (ii) delivery of awritten or electronic notice that the Option Holder has placed a market sell order with a broker acceptable to the Company with respectto Shares then issuable upon exercise or vesting of an Award, and that the broker has been directed to pay a sufficient portion of the netproceeds of the sale to the Company in satisfaction of the aggregate payments required; provided that payment of such proceeds is thenmade to the Company upon settlement of such sale. In the event that this Stock Option is exercised by an Option Holder other than theParticipant, the Company will be under no obligation to deliver Shares hereunder unless and until it is satisfied as to the authority of theOption Holder to exercise this Stock Option.(b)The provisions of Section 5.4(b) of the Plan apply with respect to the term of the Award following a Terminationof Service. Without limiting the foregoing, if the Participant has a Termination of Service prior to the expiration of this Stock OptionAward, unless varied by the Administrator in advance of the Termination of Service date, any unvested portion of this Award shall beforfeited and the Participant shall have one (1) year to exercise the vested portion of this Award. Any such exercise shall  be transacted in accordance with this Agreement and the Plan. 3.Notice of Disposition. The person exercising this Stock Option shall notify the Company when making any disposition of theShares acquired upon exercise of this Stock Option, whether by sale, gift or otherwise.4.Restrictions on Transfer of Shares. If at the time this Stock Option is exercised, the Company and any of its stockholders is aparty to any agreement restricting the transfer of any outstanding shares of the Company’s common stock, the Administrator mayprovide that this Stock Option may be exercised only if the Shares so acquired are made subject to the transfer restrictions set forth inthat agreement (or if more than one such agreement is then in effect, the agreement or agreements specified by the Administrator).5.Withholding; Agreement to Provide Security. If at the time this Stock Option is exercised the Company determines thatunder applicable law and regulations it could be liable for the withholding of any federal or state tax upon exercise or with respect to adisposition of any Shares acquired upon exercise of this Stock Option, this Stock Option may not be exercised unless the personexercising this Stock Option remits to the Company any amounts determined by the Company to be required to be withheld uponexercise (or makes other arrangements satisfactory to the Company for the payment of such taxes) and gives such security as theCompany deems adequate to meet its potential liability for the withholding of tax upon a disposition of the Shares and agrees toaugment such security from time to time in any amount reasonably determined by the Company to be necessary to preserve theadequacy of such security.6.Nontransferability of Stock Option. This Stock Option is not transferable by the Participant otherwise than by will or thelaws of descent and distribution and is exercisable during the Participant’s lifetime only by the Participant (or in the event of theParticipant’s incapacity, the person or persons legally appointed to act on the Participant’s behalf). 7.Provisions of the Plan. This Stock Option is subject to the provisions of the Plan, which are incorporated herein byreference. A copy of the Plan as in effect on the date of the grant of this Stock Option has been furnished to the Participant. Byexercising all or any part of this Stock Option, the Participant agrees to be bound by the terms of the Plan and this certificate. Allinitially capitalized terms used herein will have the meaning specified in the Plan, unless another meaning is specified herein. [The remainder of this page is intentionally left blank]2  IN WITNESS WHEREOF, the Company has caused this instrument to be executed by its duly authorized officer. OpGen, Inc. Dated: _________________________________By: Timothy C. DecTitle: Chief Financial Officer Acknowledged and agreed:Participant Dated: _________________________________Name: [Stock Option Award Agreement Signature Page]Exhibit 10.9.3Non-Employee DirectorsAnnual Stock Option Award AgreementGranted Under OpGen, Inc. 2015 Equity Incentive Plan 1.Grant of Option. This certificate evidences a non-qualified stock option (this “Stock Option”) granted by OpGen, Inc., aDelaware corporation (the “Company”), on ______________ (the “Grant Date”), to ____________ (the “Participant”), pursuant to theCompany’s 2015 Equity Incentive Plan (as from time to time in effect, the “Plan”). Under this Stock Option, the Participant maypurchase, in whole or in part, on the terms herein provided, a total of twelve thousand five hundred (12,500) shares of common stockof the Company (the “Shares”) at $___ per Share, which is equal to the fair market value of the Shares on the Grant Date. The latestdate on which this Stock Option, or any part thereof, may be exercised is __________ [ten year anniversary of the Grant Date] (the“Final Exercise Date”). The Stock Option evidenced by this certificate is intended to be, and is hereby designated, as a nonstatutoryoption, that is, an option that does not qualify as an incentive stock option as defined in section 422 of the Internal Revenue Code of1986, as amended from time to time (the “Code”). Defined terms used in this Award Agreement without definition have the meaningsset forth in the Plan.This Stock Option is exercisable in the following installments prior to the Final Exercise Date: twenty-five percent (25%) of the StockOption will vest and become exercisable on the first business day of the next four calendar quarters or ____, 1, 20__, ____ 1, 20__,_____ 1, 20__ and _____ 1, 20__. 2.Exercise of Stock Option. (a)Each election to exercise this Stock Option shall be in writing, signed by the Participant or the Participant’sexecutor, administrator, or legally appointed representative (in the event of the Participant’s incapacity) or the person or persons towhom this Stock Option is transferred by will or the applicable laws of descent and distribution (collectively, the “Option Holder”), andreceived by the Company at its principal office, accompanied by this certificate and payment in full as provided in the Plan. Subject tothe further terms and conditions provided in the Plan, the purchase price may be paid as follows: (i) cash or check, or (ii) delivery of awritten or electronic notice that the Option Holder has placed a market sell order with a broker acceptable to the Company with respectto Shares then issuable upon exercise or vesting of an Award, and that the broker has been directed to pay a sufficient portion of the netproceeds of the sale to the Company in satisfaction of the aggregate payments required; provided that payment of such proceeds is thenmade to the Company upon settlement of such sale. In the event that this Stock Option is exercised by an Option Holder other than theParticipant, the Company will be under no obligation to deliver Shares hereunder unless and until it is satisfied as to the authority of theOption Holder to exercise this Stock Option.(b)The provisions of Section 5.4(b) of the Plan apply with respect to the term of the Award following a Terminationof Service. Without limiting the foregoing, if the Participant has a Termination of Service prior to the expiration of this Stock OptionAward, unless varied by the Administrator in advance of the Termination of Service date, any unvested portion of this Award shall beforfeited and the Participant shall have one (1) year to exercise the vested portion of this Award. Any such exercise shall be transactedin accordance with this Agreement and the Plan.  3.Notice of Disposition. The person exercising this Stock Option shall notify the Company when making any disposition of theShares acquired upon exercise of this Stock Option, whether by sale, gift or otherwise.4.Restrictions on Transfer of Shares. If at the time this Stock Option is exercised, the Company and any of its stockholders is aparty to any agreement restricting the transfer of any outstanding shares of the Company’s common stock, the Administrator mayprovide that this Stock Option may be exercised only if the Shares so acquired are made subject to the transfer restrictions set forth inthat agreement (or if more than one such agreement is then in effect, the agreement or agreements specified by the Administrator).5.Withholding; Agreement to Provide Security. If at the time this Stock Option is exercised the Company determines thatunder applicable law and regulations it could be liable for the withholding of any federal or state tax upon exercise or with respect to adisposition of any Shares acquired upon exercise of this Stock Option, this Stock Option may not be exercised unless the personexercising this Stock Option remits to the Company any amounts determined by the Company to be required to be withheld uponexercise (or makes other arrangements satisfactory to the Company for the payment of such taxes) and gives such security as theCompany deems adequate to meet its potential liability for the withholding of tax upon a disposition of the Shares and agrees toaugment such security from time to time in any amount reasonably determined by the Company to be necessary to preserve theadequacy of such security.6.Nontransferability of Stock Option. This Stock Option is not transferable by the Participant otherwise than by will or thelaws of descent and distribution and is exercisable during the Participant’s lifetime only by the Participant (or in the event of theParticipant’s incapacity, the person or persons legally appointed to act on the Participant’s behalf). 7.Provisions of the Plan. This Stock Option is subject to the provisions of the Plan, which are incorporated herein byreference. A copy of the Plan as in effect on the date of the grant of this Stock Option has been furnished to the Participant. Byexercising all or any part of this Stock Option, the Participant agrees to be bound by the terms of the Plan and this certificate. Allinitially capitalized terms used herein will have the meaning specified in the Plan, unless another meaning is specified herein. [The remainder of this page is intentionally left blank]2  IN WITNESS WHEREOF, the Company has caused this instrument to be executed by its duly authorized officer. OpGen, Inc. Dated: _________________________________By: Timothy C. DecTitle: Chief Financial Officer Acknowledged and agreed:Participant Dated: _________________________________Name: [Stock Option Award Agreement Signature Page]Exhibit 10.10OPGEN, INC.RESTRICTED STOCK UNIT AWARD AGREEMENTThis RESTRICTED STOCK UNIT AWARD AGREEMENT (this “Agreement”) dated as of [_______] (the “Date ofGrant”), is made by OpGen, Inc., a Delaware corporation, (the “Company”), to [__________] (the “Participant”).RECITALSThe 2015 Equity Incentive Plan of the Company (the “Plan”) provides for the issuance of equity awards to “EligibleIndividuals” of the Company, and the Participant is an Eligible Individual under the Plan. The Board of Directors has determined that it is in the best interests of the Company and its stockholders to grant therestricted stock unit award provided for herein to the Participant pursuant to the terms set forth herein as an incentive for the Participantto contribute to the Company’s future success and prosperity.NOW THEREFORE, in consideration of the mutual covenants hereinafter set forth, the parties hereto agree as follows:1.Award of the Restricted Stock Units. (a)The Company hereby grants to the Participant [_______] restricted stock units (“Restricted Stock Units”),representing the right to receive an equal number of shares of common stock of the Company (the “Shares”), upon the lapse offorfeiture restrictions (“vesting”) of some or all of such Restricted Stock Units, subject to the terms and conditions set forth in thisAgreement. (b)The Restricted Stock Units are awarded to the Participant under the Plan and are subject to the terms andconditions set forth in the Plan, including the discretion of the Committee under the Plan, subject to any specific provisions set forth inthis Agreement. A copy of the Plan is attached to this Agreement and made a part hereof. Capitalized terms not defined in thisAgreement shall have the meanings set forth in the Plan. (c)Upon vesting of the Restricted Stock Units, the Restricted Stock Units will be settled by a delivery of Shares. Nodividend equivalents are authorized as part of the award of these Restricted Stock Units.(d)Prior to vesting of the Restricted Stock Units pursuant to Sections 2 or 3 of this Agreement: (i) the Participantshall not be treated as a stockholder as to Shares issuable to the Participant with respect to such Restricted Stock Units, and shall onlyhave a contractual right to receive such Shares following such vesting, unsecured by any assets of the Company or its Subsidiaries;(ii) the Participant shall not be permitted to vote the Restricted Stock Units or the Shares issuable with respect to such Restricted StockUnits; and (iii) the Participant’s right to receive such Shares following vesting of the Restricted Stock Units shall be subject to theadjustment provisions set forth in Section 10(c) of the Plan. The Restricted Stock Units shall be subject to all of the restrictionshereinafter set forth.  2.Vesting; Lapse of Forfeiture.(a)Except as otherwise provided in this Section 2 and in Section 3 hereof, the forfeiture restrictions shall lapse andthe Restricted Stock Units shall vest in accordance with the following schedule: [_______].(b)Notwithstanding any other provision of the Plan or this Agreement to the contrary, until the restrictions set forth inthis Section 2 have lapsed, the Restricted Stock Units may not be transferred, assigned or otherwise encumbered other than inaccordance with the applicable provisions of Section 6 hereof. 3.Change in Control and other Corporation Changes. The provisions of Section 13.2 of the Plan shall apply to the Restricted Stock Units under this Agreement. 4.Issuance of Certificates. Following the applicable vesting date with respect to the Restricted Stock Units, and subject to the terms and conditions of the Plan,the Company will issue a stock certificate for the Shares issuable with respect to such vested Restricted Stock Units. Such issuanceshall take place as soon as practicable following the applicable vesting date (but in no event later than two and one-half monthsfollowing the end of the calendar year in which the vesting date occurs). The certificates representing the Shares issued in respect ofthe Restricted Stock Units shall be subject to such stop transfer orders and other restrictions as the Committee may determine isrequired by the rules, regulations, and other requirements of the Securities and Exchange Commission, any stock exchange uponwhich such Shares are listed, any applicable federal or state laws and the Company’s Certificate of Incorporation and Bylaws, and theCommittee may cause a legend or legends to be put on any such certificates to make appropriate reference to such restrictions.5.No Right to Continued Employment. Neither the Plan nor this Agreement shall confer on the Participant any right to be retained, in any position, as an employee,consultant or director of the Company.6.Transferability.(a)The Restricted Stock Units are not transferable and may not be sold, assigned, transferred, disposed of, pledged orotherwise encumbered by the Participant, other than by will or the laws of descent and distribution. Upon such transfer (by will or thelaws of descent and distribution), such transferee in interest shall take the rights granted herein subject to all the terms and conditionshereof.(b)Subject to Section 6(a) hereof, in order to comply with any applicable securities laws, the Participant agrees that theShares issued to the Participant with respect to vested Restricted Stock Units shall only be sold by the Participant following registrationof such Shares under the Securities Act of 1933, as amended, or pursuant to an exemption therefrom.7.Withholding. The Participant shall pay to the Company promptly upon request, and in any event at the time the Participant recognizes taxableincome in respect of the Restricted Stock Units, an amount equal to the federal, state or local taxes the Company determines it isrequired to withhold with respect to the Restricted Stock Units. Such payment shall be made in the form2 of cash. The net settlement of the Shares underlying the vested Restricted Stock Units and the delivery of Shares previously owned insatisfaction of any withholding obligation are hereby specifically [not] authorized alternatives for the satisfaction of the foregoingwithholding obligation. 8.Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to theconflicts of law provisions thereof.9.Amendments. This Agreement may be amended or modified at any time by an instrument in writing signed by the parties hereto, except asotherwise provided in Section 12 of this Agreement regarding permitted unilateral action by the Committee or in Section 12.2 of thePlan related to amendments or alterations that do not adversely affect the rights of the Participant in this Award.10.Administration. This Agreement shall at all times be interpreted in accordance with the terms and conditions of the Plan as if set forth herein. TheCommittee shall have sole and complete discretion under this Agreement with respect to all matters reserved to it by the Plan anddecisions of the Committee with respect thereto and this Agreement shall be final and binding upon the Participant and theCompany. In the event of any conflict between the terms and conditions of this Agreement and the Plan, the provisions of thisAgreement shall control. The Committee has the authority and discretion to determine any questions which arise in connection withthe award of the Restricted Share Units hereunder.11.Compliance with Code Section 409A. It is the intention of the Company and Participant that this Agreement not result in an unfavorable tax consequences to Participantunder Code Section 409A. Accordingly, Participant consents to any amendment of this Agreement as the Company may reasonablymake in furtherance of such intention, and the Company shall make available to the Participant a copy of such amendment. Any suchamendments shall be made in a manner that preserves to the maximum extent possible the intended benefits to Participant. Thisparagraph does not create an obligation on the part of Company to modify this Agreement and does not guarantee that the amounts orbenefits owed under the Agreement will not be subject to interest and penalties under Code Section 409A.12.Imposition of Other Requirements. The Company reserves the right to impose other requirements on the Restricted Stock Units and on any Shares acquired under thePlan, to the extent the Company determines it is necessary or advisable in order to comply with local law or facilitate the administrationof the Award, and to require the Participant to sign any additional agreements or undertakings that may be necessary to accomplish theforegoing. The Participant agrees, upon demand of the Company or the Committee, to do all acts and execute, deliver and perform alladditional documents, instruments and agreements which may be reasonably required by the Company or the Committee, as the casemay be, to implement the provisions and purposes of this Agreement.13.Notices. Any notice, request, instruction or other document given under this Agreement shall be in writing and may be delivered by suchmethod as may be permitted by the Company, and shall be addressed and delivered, in the case of the Company, to the Secretary of theCompany at the principal office of the Company and, in the case of the Participant, to the3 Participant’s address as shown in the records of the Company or to such other address as may be designated in writing (or by suchother method approved by the Company) by either party.14.Severability. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any otherprovision of this Agreement, and each other provision of the Agreement shall be severable and enforceable to the extent permitted bylaw. [Signatures on the following page.]4 IN WITNESS WHEREOF, the Company and the Participant hereby execute this Agreement. OPGEN, INC. By: Name: Title: Date: Accepted: PARTICIPANT By: Name: Date: 5 Exhibit 21.1OPGEN, INC.The following is a list of subsidiaries of OpGen, Inc. as of December 31, 2016: Name Jurisdiction of IncorporationAdvanDx, Inc. DelawareAdvanDx A/S Denmark  Exhibit 23.1Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in Registration Statements No. 333-210489 and No. 333-205864 on Form S-8 and Registration Statements No.333-213356 and No. 333-211996 on Form S-3 of OpGen, Inc. of our report, which includes an explanatory paragraph related to OpGen, Inc.’s ability tocontinue as a going concern, dated March 23, 2017, on our audits of the consolidated financial statements of OpGen, Inc. as of December 31, 2016 and 2015and for the years then ended, included in this Annual Report on Form 10-K of OpGen, Inc. for the year ended December 31, 2016./s/ CohnReznick LLPVienna, VirginiaMarch 23, 2017  Exhibit 31.1CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TORULE 13A-14(A)/15D-14(A)I, Evan Jones, certify that:1.I have reviewed this Annual Report on Form 10-K of OpGen, Inc.;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 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,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others withinthose entities, particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed 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 mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer 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 arereasonably likely 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 internalcontrol over financial reporting. Date: March 24, 2017 /s/ Evan Jones Evan Jones Chief Executive Officer (principal executive officer)  Exhibit 31.2CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TORULE 13A-14(A)/15D-14(A)I, Timothy C. Dec, certify that:1.I have reviewed this Annual Report on Form 10-K of OpGen, Inc.;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 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,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others withinthose entities, particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed 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 mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer 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 arereasonably likely 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 internalcontrol over financial reporting. Date: March 24, 2017 /s/ Timothy C. Dec Timothy C. Dec Chief Financial Officer (principal financial officer andprincipal accounting officer)  Exhibit 32.1CERTIFICATIONPURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTEDPURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with the Annual Report on Form 10-K of OpGen, Inc. (the “Company”) for the year ended December 31, 2016 (the “Report”) as filed with theSecurities and Exchange Commission on the date hereof, the undersigned Chief Executive Officer and Chief Financial Officer of the Company hereby certifythat, to such officer’s knowledge: (1)the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of theCompany.This certification is provided solely pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Date: March 24, 2017 /s/ Evan Jones Evan Jones Chief Executive Officer (principal executive officer) Date: March 24, 2017 /s/ Timothy C. Dec Timothy C. Dec Chief Financial Officer(principal financial officer and principal accounting officer) A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished tothe Securities and Exchange Commission or its staff upon request. 

Continue reading text version or see original annual report in PDF format above