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•	the initiation, cost, timing, progress and results of our research and development activities, preclinical studies and future clinical trials;

•	our ability to obtain and maintain regulatory approval of our current and future product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;

•	our ability to obtain funding for our operations;

•	our plans to research, develop and commercialize our future product candidates;

•	our strategic alliance partners’ election to pursue development and commercialization;

•	our ability to attract collaborators with development, regulatory and commercialization expertise;

•	our ability to obtain and maintain intellectual property protection for our future product candidates;

•	the size and growth potential of the markets for our current and future product candidates, and our ability to serve those markets;

•	our ability to successfully commercialize our current and future product candidates;

•	the rate and degree of market acceptance of our current and future product candidates;

•	our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;

•	regulatory developments in the United States and foreign countries;

•	the performance of our third-party suppliers and manufacturers;

•	the success of competing therapies that are or become available;

•	the loss of key scientific or management personnel;

•	our use of the proceeds from our public offerings; and

•	the accuracy of our estimates regarding expenses, future revenues, capital requirements and need for additional financing.

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I.	Oral Formulations of Brincidofovir

A.	Oral Brincidofovir for Treatment of AdV

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B.	Oral Brincidofovir for Treatment of Smallpox

C.	Oral Brincidofovir Expanded Access Program

II.	IV Formulation of Brincidofovir

A.	IV Brincidofovir Multiple Ascending Dose Study in Healthy Subjects

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B.	Phase 2 Studies Planned to Initiate in 1H2018

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Advance Oral and IV Formulations of Brincidofovir for the Prevention and Treatment of Serious DNA Virus Infections. We are conducting AdAPT, a small comparative clinical trial designed to study the effect of brincidofovir versus SOC in pediatric patients with AdV infection following allogeneic HCT. This study will be conducted at sites in the United States and Europe. If successful, AdAPT may form the basis of an application for conditional or full marketing approval of brincidofovir in the EU for the treatment of AdV infection in HCT recipients. A successful trial may also further support potential continued development of oral brincidofovir in the U.S. Assuming the trial is fully enrolled by the first half of 2019, we expect to receive data from the trial in the second half of 2019 with the potential for an EU approval in 2020.

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Progress Development of Brincidofovir as a Medical Countermeasure for the Treatment of Smallpox. We have conducted efficacy studies under the FDA’s Animal Rule to demonstrate the impact of immediate or delayed brincidofovir in a well-characterized model of smallpox infection. We are working with the FDA and BARDA on the development of our second, adjunct rabbitpox study as well as a second animal model, mousepox. We plan to submit an NDA to the FDA, contingent upon the results of the animal efficacy studies we intend to conduct during 2018. In addition, we received advice from the EMA on the development plan for smallpox, in which the submission of a marketing application with data from completed studies, including our earlier completed large rabbitpox efficacy study, was discussed. This study in combination with supportive mousepox study data was considered sufficient for review by EMA. We are in the process of preparing for a marketing application submission to EMA in early 2019.

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Develop CMX521 for the Prevention and Treatment of Norovirus. We are currently conducting a first-time-in-human study of CMX521. This Phase 1 study is evaluating the pharmacokinetics, safety and tolerability of CMX521 in up to 50 adult subjects. The study also includes the collection of gut biopsy specimens, which will allow for the determination of active drug concentrations in the target gut tissue. Study results are expected in mid-2018.

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Discover and Develop Additional Product Candidates to Strengthen our Product Portfolio. We have an active discovery and preclinical development program focused on identifying and developing new compounds that can be used to treat diseases for which no current therapeutic option exists or which otherwise continue to have high unmet medical need. We intend to leverage our knowledge and experience of nucleoside analogs to advance compounds in the Chimerix Chemical Library through IND-enabling studies and potential clinical development and/or

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Evaluate external opportunities to strengthen our pipeline. We are looking at business development opportunities as a means to complement our existing pipeline with technologies that will take advantage of our strengths. We are actively seeking opportunities to grow our business through the acquisition of or investment in other companies, through strategic relationships, or through in-licensing of complementary compounds and products.

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•	Vistide® (cidofovir for injection), marketed by Gilead Sciences, Inc. and generic manufacturers; and

•	patient-specific T-cell therapies.

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•	letermovir (marketed under the trade name PREVYMIS), an anti-CMV drug recently approved for the prevention of CMV infections in adult HCT recipients pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck & Co., Inc.;

•	maribavir, an antiviral owned by Shire plc, currently in Phase 3 trials for the treatment of CMV resistant or refractory CMV infections in both HCT and SOT adult patients, and for preemptive use in adult HCT patients; and

•	patient-specific T-cell therapies directed at antigens of CMV and other dsDNA viruses.

•	146 patents or patent applications that we own or have in-licensed from academic institutions, related to brincidofovir and CMX157, which represented a slight increase over the number of patents in our patent portfolio at the end of fiscal 2016;

•	This includes 96 US and foreign exclusively and jointly owned patents and 50 US and foreign applications related to brincidofovir and CMX157. Granted European patents are counted as one patent and have been validated throughout Europe;

•	20 jointly-owned patents or patent applications related to our agreement with the UM regarding our proprietary Chemical Library; and

•	One US provisional patent application owned exclusively by Chimerix directed to a morphic form of a compound from the Chemical Library.

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•	completion of nonclinical laboratory tests, animal studies and formulation studies according to good laboratory practices (GLP), or other applicable regulations;

•	submission to the FDA of an application for an IND, which must become effective before human clinical trials may begin;

•	performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as current good clinical practices (GCPs), to establish the safety and efficacy of the proposed drug for its intended use;

•	submission to the FDA of a NDA for a new drug;

•	satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with the FDA’s current good manufacturing practice standards (cGMP), to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

•	potential FDA inspection of the nonclinical and clinical trial sites that generated the data in support of the NDA; and FDA review of the NDA.

•	Phase 1.   The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

•	Phase 2.   The drug is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.

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Phase 3.   Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA.

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•	aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases;

•	intended for use in emergency situations (also less comprehensive pharmaceutical and non-clinical data may be accepted for such products); and/or

•	designated as orphan medicines.

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•	it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;

•	the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; and

•	no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

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•	continue the development of our lead product candidate, brincidofovir, for the treatment of AdV infection;

•	advance the development of an IV formulation of brincidofovir;

•	continue the development of brincidofovir for the prevention or treatment of CMV, AdV, BK virus, and other viral indications in HCT recipients, solid organ transplant recipients and other patient populations;

•	continue the development of brincidofovir for the treatment of smallpox as a medical countermeasure;

•	obtain regulatory approvals for brincidofovir;

•	scale-up manufacturing capabilities to commercialize brincidofovir for any indications for which we receive regulatory approval;

•	advance the development of CMX521 for norovirus;

•	expand our research and development activities and advance our clinical programs;

•	maintain, expand and protect our intellectual property portfolio;

•	continue our research and development efforts and seek to discover additional product candidates; and

•	add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and operations as a public company.

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•	obtaining favorable results for and advancing the development of brincidofovir and our other product candidates, including successfully completing clinical development of IV and oral formulations of brincidofovir;

•	obtaining United States and foreign regulatory approval(s) for brincidofovir;

•	launching and commercializing brincidofovir, including establishing a sales force and/or collaborating with third party providers of sales organizations;

•	achieving broad market acceptance of brincidofovir in the medical community and with third-party payers;

•	delivering a competitive value proposition compared to established competition and/or competitors who will enter the market before or after any of our product candidates, including brincidofovir; and

•	generating, licensing or otherwise acquiring a pipeline of product candidates which progress to clinical development, regulatory approval, and commercialization.

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•	significantly delay, scale back or discontinue the development or commercialization of our product candidates, including brincidofovir;

•	seek corporate partners for brincidofovir or any of our other product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or

•	relinquish or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves.

•	successful conduct of required trial(s) of oral brincidofovir for the treatment of adenovirus;

•	successful conduct of a second efficacy study of oral brincidofovir in an animal model of smallpox infection, and acceptance of data from these animal model studies by the FDA and foreign regulatory bodies;

•	development of an IV formulation and/or alternate drug formulations;

•	receipt of marketing approvals from the FDA and corresponding regulatory authorities outside the United States;

•	establishing commercial manufacturing capabilities;

•	launching commercial sales of the product, whether alone or in collaboration with others;

•	acceptance of the product by patients, the medical community and third-party payers;

•	effectively competing with other therapies;

•	a continued acceptable safety profile of the product following approval;

•	obtaining, maintaining, enforcing and defending intellectual property rights and claims; and

•	establishing distribution channels in the EU and U.S.

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•	regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

•	clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

•	animal efficacy studies of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us to conduct additional animal efficacy studies or abandon development programs;

•	we might be required to change one of our clinical research organizations (CROs) during ongoing clinical programs;

•	the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate or subjects may drop out of these clinical trials at a higher rate than we anticipate;

•	our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

•	we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the subjects are being exposed to unacceptable health risks;

•	regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;

•	the cost of clinical trials of our product candidates may be greater than we anticipate;

•	we may encounter agency or judicial enforcement actions which impact our clinical trials;

•	the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; or

•	our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials.

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•	inability to raise funding necessary to initiate or continue a trial;

•	delays in obtaining, or failure to obtain, regulatory approval of Investigational New Drug applications or to commence a trial;

•	delays in reaching agreement with the FDA and foreign health authorities on final trial design;

•	imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities;

•	delays caused by disagreements with existing CROs and/or clinical trial sites;

•	delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;

•	delays in obtaining, or failure to obtain, required IRB or ethics committee (EC) approvals covering each site;

•	delays in recruiting suitable patients to participate in a trial;

•	delays in having subjects complete participation in a trial or return for post-treatment follow-up;

•	delays caused by subjects dropping out of a trial due to side effects or otherwise;

•	clinical sites declining to participate or dropping out of a trial to the detriment of enrollment;

•	agency or judicial enforcement actions against us;

•	time required to add new clinical sites; and

•	delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.

•	regulatory authorities may approve the product only with a REMS, potentially with restrictions on distribution and other elements to assure safe use (ETASU);

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•	regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in a form of a modified REMS;

•	regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

•	we may be required to change the way the product is administered or to conduct additional clinical studies;

•	we could be sued and held liable for harm caused to patients; and

•	our reputation may suffer.

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•	issue an untitled or warning letter asserting that we are in violation of the law;

•	seek an injunction or impose civil or criminal penalties or monetary fines;

•	suspend or withdraw regulatory approval;

•	suspend any ongoing clinical trials;

•	refuse to approve a pending application or supplements to an application submitted by us;

•	recall and/or seize product; or

•	refuse to allow us to enter into supply contracts, including government contracts.

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the federal healthcare anti-kickback statute which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid;

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the federal civil and criminal false claims laws and civil monetary penalties, including civil whistleblower or qui tam actions, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent or from knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government;

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the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which, among other things, imposes criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly or willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statement in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and its implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, clearinghouses and certain healthcare providers, as well as their business associates;

•	the EU Data Privacy Directive, along with any related national legislation, and the General Data Protection Regulation (GDPR), which all impose obligations on companies in relation to the handling of personal data of individuals within the EU;

•	mandated physician payments reporting laws and/or requirements throughout global jurisdictions, including EU member states, in which we conduct research and development and/or other business activities;

•	the FDCA which prohibits, among other things, the adulteration or misbranding of drugs and devices;

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the federal transparency law, enacted as part of the Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), and its implementing regulations, which requires manufacturers of drugs, devices, biologicals and medical supplies to report to the U.S. Department of Health and Human Services information related to payments and other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and

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analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by state governmental and non-governmental third-party payers, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; and state laws and regulations that require manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities.

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•	inability to meet our product specifications and quality requirements consistently;

•	delay or inability to procure or expand sufficient manufacturing capacity;

•	manufacturing and product quality issues related to scale-up of manufacturing;

•	costs and validation of new equipment and facilities required for scale-up;

•	failure to comply with cGMP and similar foreign standards;

•	inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;

•	termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

•	reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates in a timely fashion, in sufficient quantities or under acceptable terms;

•	lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;

•	operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier;

•	carrier disruptions or increased costs that are beyond our control; and

•	failure to deliver our products under specified storage conditions and in a timely manner.

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•	lacks or does not devote sufficient time and resources to the development and commercialization of CMX157;

•	lacks or does not devote sufficient capital to fund the development and commercialization of CMX157;

•	develops, either alone or with others, products that compete with CMX157;

•	fails to gain the requisite regulatory approvals for CMX157;

•	does not successfully commercialize CMX157;

•	does not conduct its activities in a timely manner;

•	terminates its license with us;

•	does not effectively pursue and enforce intellectual property rights relating to CMX157; or

•	merges with a third-party that wants to terminate the collaboration.

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•	demonstration of clinical safety and efficacy in our clinical trials;

•	relative convenience, ease of administration and acceptance by physicians, patients, pharmacists and health care payers;

•	prevalence and severity of any AEs;

•	limitations or warnings contained in the FDA-approved labeling from Regulatory Authorities such as the FDA and EMA for the relevant product candidate;

•	availability, efficacy and safety of alternative treatments;

•	price and cost-effectiveness;

•	effectiveness of our or any future collaborators’ or competitor’s sales and marketing strategies;

•	ability to obtain hospital formulary approval;

•	ability to ensure availability for product through appropriate channels;

•	ability to maintain adequate inventory; and

•	ability to obtain and maintain sufficient third-party coverage and reimbursement, which may vary from country to country.

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•	recruiting and retaining talented people;

•	training employees that we recruit;

•	establishing compliance standards;

•	setting the appropriate system of incentives;

•	managing additional headcount;

•	ensuring that appropriate support functions are in place to support sales force organizational needs; and

•	integrating a new business unit into an existing corporate architecture.

•	different regulatory requirements for drug approvals in the EU and other foreign countries;

•	reduced protection for intellectual property rights;

•	unexpected changes in tariffs, trade barriers and regulatory and labor requirements;

•	economic weakness, including inflation, or political instability in particular foreign economies and markets;

•	compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

•	foreign taxes, including withholding of payroll taxes;

•	foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

•	workforce uncertainty in countries where labor unrest is more common than in the United States;

•	production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;

•	business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires; and

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•	regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti‑bribery provisions, or similar anti‑bribery or anti‑corruption laws and regulations.

•	Vistide® (cidofovir for injection), marketed by Gilead Sciences, Inc. and generic manufacturers;

•	oral and intravenous ganciclovir, a drug that is sold by generic manufacturers;

•	Valcyte® (valganciclovir), a prodrug of ganciclovir that is marketed by Genentech, Inc. and generic manufacturers;

•	foscarnet sodium for injection available through generic manufacturers;

•	acyclovir, a drug that is sold by generic manufacturers;

•	letermovir (marketed under the trade name PREVYMIS), an anti-CMV drug being developed pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck & Co., Inc.; and

•	investigational patient-specific T-cell therapies.

•	maribavir (SHP620) from Shire for CMV infections in transplant recipients; and

•	patient-specific T-cell therapies directed at antigens of CMV and other DNA viruses, including AdV.

•	discover and develop medicines that are superior to other products in the market;

•	demonstrate through our clinical trials that our product candidates, including brincidofovir, are differentiated from existing and future therapies;

•	evaluate new potential indications across the lifecycle of brincidofovir;

•	attract qualified scientific, product development and commercial personnel;

•	obtain and successfully defend and enforce patent and/or other proprietary protection for our medicines and technologies;

•	obtain required regulatory approvals;

•	successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines;

•	deliver a competitive value proposition compared to established competition and/or competitors who will enter the market before or after any of our product candidates, including brincidofovir; and

•	negotiate competitive pricing and reimbursement with third-party payers.

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•	our research methodology or that of our collaboration partners may be unsuccessful in identifying potential product candidates;

•	our potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval; and

•	our collaboration partners may change their development profiles for potential product candidates or abandon a therapeutic area.

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•	audit and object to any BARDA contract-related costs and fees on grounds that they are not allowable under the FAR, and require us to reimburse all such costs and fees;

•	suspend or prevent us for a set period of time from receiving new contracts or extending our existing contract based on violations or suspected violations of laws or regulations;

•	claim nonexclusive, nontransferable rights to product manufactured and intellectual property developed under the BARDA contract and may, under certain circumstances, such as circumstances involving public health and safety, license such inventions to third parties without our consent;

•	cancel, terminate or suspend our BARDA contract based on violations or suspected violations of laws or regulations;

•	terminate our BARDA contract in whole or in part for the convenience of the government for any reason or no reason, including if funds become unavailable to the applicable governmental agency;

•	reduce the scope and value of our BARDA contract;

•	decline to exercise an option to continue the BARDA contract;

•	direct the course of a development program in a manner not chosen by the government contractor;

•	require us to perform the option segments even if doing so may cause us to forego or delay the pursuit of other opportunities with greater commercial potential;

•	take actions that result in a longer development timeline than expected; and

•	change certain terms and conditions in our BARDA contract.

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FAR, and agency-specific regulations supplements to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts and implement federal procurement policy in numerous areas, such as employment practices, protection of the environment, accuracy and retention periods of records, recording and charging of costs, treatment of laboratory animals and human subject research;

•	business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and the Foreign Corrupt Practices Act;

•	export and import control laws and regulations; and

•	laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data.

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•	termination of contracts;

•	forfeiture of profits;

•	suspension of payments;

•	fines; and

•	suspension or prohibition from conducting business with the U.S. government.

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•	impairment of our business reputation and significant negative media attention;

•	withdrawal of participants from our clinical studies;

•	significant costs to defend the related litigation and related litigation;

•	distraction of management’s attention from our primary business;

•	substantial monetary awards to patients or other claimants;

•	inability to commercialize our product candidates, including brincidofovir; and

•	decreased demand for our product candidates, if approved for commercial sale.

•	multiple, conflicting and changing laws and regulations such as tax laws, privacy regulations, export and import restrictions, employment, immigration and labor laws, regulatory requirements, and other governmental approvals, permits and licenses;

•	difficulties in staffing and managing foreign operations;

•	risks associated with obtaining and maintaining, or the failure to obtain or maintain, regulatory approvals for the sale or use of our products in various countries;

•	complexities associated with managing government payer systems, multiple payer-reimbursement regimes or patient self-pay systems;

•	financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;

•	general political and economic conditions in the countries in operate, including terrorism and political unrest, curtailment of trade and other business restrictions;

•	regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti-bribery provisions, or similar anti-bribery or anti-corruption laws and regulations.

•	results of clinical trials of our product candidates or those of our competitors;

•	any delay in filing an application for any of our product candidates and any adverse development or perceived adverse development with respect to regulatory review of that application;

•	failure to successfully develop and commercialize our product candidates, including brincidofovir;

•	termination of any of our license or collaboration agreements;

•	any agency or judicial enforcement actions against us;

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•	inability to obtain additional funding;

•	regulatory or legal developments in the United States and other countries applicable to our product candidates;

•	adverse regulatory decisions;

•	changes in the structure of healthcare payment systems;

•	inability to obtain adequate product supply for our product candidates, or the inability to do so at acceptable prices;

•	introduction of new products, services or technologies by our competitors;

•	failure to meet or exceed financial projections we provide to the public;

•	failure to meet or exceed the estimates and projections of the investment community;

•	changes in the market valuations of similar companies;

•	market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations;

•	announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

•	significant lawsuits (including patent or stockholder litigation), and disputes or other developments relating to proprietary rights (including patents, litigation matters and our ability to obtain patent protection for our technologies);

•	additions or departures of key scientific or management personnel;

•	sales of our common stock by us or our stockholders in the future;

•	trading volume of our common stock;

•	general economic, industry and market conditions; and

•	the other factors described in this “Risk Factors” section.

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•	authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors;

•	allowing the authorized number of our directors to be changed only by resolution of our board of directors;

•	limiting the removal of directors;

•	creating a staggered board of directors;

•	requiring that stockholder actions must be effected at a duly called stockholder meeting and prohibiting stockholder actions by written consent;

•	eliminating the ability of stockholders to call a special meeting of stockholders; and

•	establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at duly called stockholder meetings.

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(1)	Further details of investments is available in "Notes to Consolidated Financial Statements, Note 1. Fair Value of Financial Instruments" in Item 8 of this Annual Report.

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•	fees paid to consultants and contract research organizations (CROs), including in connection with our preclinical and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis;

•	salaries and related overhead expenses, which include stock option, restricted stock unit (RSU) and employee stock purchase program compensation and benefits, for personnel in research and development functions;

•	payments to third-party manufacturers, which produce, test and package our drug substance and drug product (including continued testing of process validation and stability);

•	costs related to legal and compliance with regulatory requirements; and

•	license fees for and milestone payments related to licensed products and technologies.

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•	the uncertainty of the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

•	the potential benefits of our candidates over other therapies;

•	the ability to market, commercialize and achieve market acceptance for any of our product candidates that we are developing or may develop in the future;

•	the results of ongoing or future clinical trials;

•	the timing and receipt of any regulatory approvals; and

•	the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so.

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We have limited operating history to estimate the volatility of our common stock price. We calculate expected volatility based on a blend of company specific historical data and a group of similar publicly traded companies for which the historical information is available. For the purpose of identifying peer companies, we consider characteristics such as industry, length of trading history, similar vesting terms and in-the-money option status. We plan to continue to use the guideline peer group volatility information until the historical volatility of our common stock is relevant to measure expected volatility for future option grants.

•	We use historical exercise data to estimate expected term.

•	We determine the risk-free interest rate by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant.

•	The assumed dividend yield is based on our expectation of not paying dividends for the foreseeable future.

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•	We estimate forfeitures based on our historical analysis of actual stock option forfeitures.

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a decrease in oral brincidofovir clinical expenses of $6.2 million, which is comprised primarily of an $8.7 million decrease related to the completion of our Phase 3 SUPPRESS and AdVise trials and the closeout of our SUSTAIN and SURPASS trials, and a $0.6 million decrease in our expanded access programs, primarily offset by an increase of $1.8 million related to start-up activities for our AdAPT study and an increase of $1.2 million related to conduct of the AdVance study;

•	a decrease of $1.4 million in oral brincidofovir drug manufacturing costs;

•	a decrease of $1.9 million related to compensation expense;

•	a decrease of $0.9 million related to reimbursable BARDA contract expenses; and

•	a decrease of $0.8 million in supporting research and development expenses; offset by

•	an increase of approximately $2.4 million mainly related to our development of an IV formulation of brincidofovir, development of CMX521, our clinical candidate for norovirus, and other early stage compounds.

•	an increase of $2.0 million in global commercial readiness costs;

•	an increase of $1.0 million in costs related to an indemnification claim; offset by

•	a decrease of $0.6 million related to compensation expense.

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•	a decrease of $31.0 million in oral BCV clinical expenses, comprised primarily of a decrease related to the completion of our Phase 3 SUPRESS and AdVise clinical trials and the closeout of our SUSTAIN and SURPASS clinical trials;

•	a decrease of $3.1 million in costs related to the development of oral BCV drug manufacturing; and

•	a decrease in other research and development expenses; offset by

•	increase in costs of approximately $3.6 million related to the development of an IV formulation of brincidofovir and development of CMX521, our asset for norovirus

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•	a decrease of $7.1 million as we delayed our commercialization readiness activities for brincidofovir;

•	a decrease of $1.2 million in operational support costs as part of our cost-saving efforts; offset by

•	a net increase in compensation and other employee related costs of $1.9 million, consisting of an increase of $1.7 million of share-based compensation and an increase of $0.2 million of compensation and benefits.

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•	the willingness of the FDA and/or foreign regulators to accept the results from Study 999, as well as our other completed and planned clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for the treatment of AdV infection;

•	the progress, costs, results and timing of future clinical trials of brincidofovir for other potential indications, including prevention of multiple DNA virus infections and treatment of AdV, BKV and smallpox;

•	the willingness of the FDA and/or foreign regulators to accept clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for other potential indications;

•	the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

•	the ability to continue to receive government funding;

•	the achievement of milestones under our agreement with ContraVir;

•	the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;

•	the ability of our product candidates to progress through clinical development successfully;

•	our need to expand our research and development activities;

•	the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;

•	the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies;

•	our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

•	our need and ability to hire additional management and scientific and medical personnel;

•	the effect of competing technological and market developments;

•	our need to implement additional internal systems and infrastructure, including financial and reporting systems; and

•	the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future.

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(1)	Consists of our corporate headquarters lease encompassing 24,862 square feet of office space that expires in February 2021, and our laboratory leases encompassing a total of approximately 10,274 square feet which are located in Durham and Research Triangle Park, North Carolina and expire in July 2021 and August 2018, respectively.

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•	Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.

•	Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly.

•	Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

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i.	pertain to the maintenance of records, that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;

ii.	provide reasonable assurance that transactions are recorded as necessary to permit preparations of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and

iii.	provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

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1.	PREAMBLE

I.	[...***...]

II.	[...***...]

III.	[...***...]

IV.	[...***...]

V.	[...***...]

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2.	PHASE I: [...***...]

2.1.1	The overall management, integration and coordination of all contract activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all contract activities;

2.1.2	A Principal Investigator (PI) responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract.

2.1.3	Project Manager(s) with responsibility for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities; costs incurred; and program management; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract.

2.1.4	A BARDA Liaison with responsibility for effective communication with the Project Officer and Contracting Officer.

2.1.5	Administrative and legal staff to provide development of compliant subcontracts, consulting, and other legal agreements, and ensure timely acquisition of all proprietary rights, including IP rights, and reporting all inventions made in the performance of the project.

2.1.6	Administrative staff with responsibility for financial management and reporting on all activities conducted by the Contractor and any subcontractors.

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2.1.7	Contract Review Meetings.

2.1.7.1

The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting and Project Officers. Such meetings may include, but are not limited to, meeting of the Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing development, clinical sample assays development, preclinical/clinical study designs and regulatory issues; meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with technical consultants to discuss technical data provided by the Contractor.

2.1.7.2	The Contractor shall participate in teleconferences every two weeks between the Contractor and subcontractors and BARDA to review technical progress. Teleconferences or additional face-to-face meetings shall be more frequent at the request of BARDA.

2.1.8	Integrated Master Schedule

2.1.8.1

Within 30 calendar days of the effective date of the contract, the Contractor shall submit a first draft of an updated Integrated Master Schedule in a format agreed upon by BARDA to the Project Officer and the Contracting Officer for review and comment. The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract. Contractor shall include the key milestones and Go/No Go decision gates. The IMS for the period of performance will be mutually agreed upon at the PMBR

2.1.9	Integrated Master Plan

2.1.9.1

Work Breakdown Structure: The Contractor shall utilize a WBS template agreed upon by BARDA for reporting on the contact. The Contractor shall expand and delineate the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their Integrated Master Plan for contract reporting. The CWBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task.

2.1.9.2	GO/ NO-GO Decision Gates: The Integrated Master Plan outlines key milestones with "Go/No Go" decision criteria (entrance and exit criteria for each phase of the project). The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions.

2.1.9.3	Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-4, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract. The Seven Principles are:

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II.	Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.

III.	Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control Changes to the baseline.

IV.	Use actual cost incurred and recorded in accomplishing the work performed.

V.	Objectively assess accomplishments at the work performance level.

VI.	Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.

VII.	Use earned value information in the company's management processes.

2.1.10

Decision Gate Reporting: On completion of a stage of the product development, as defined in the agreed upon Integrated Master Schedule and Integrated Master Plan, the Contractor shall prepare and submit to the Project Officer and the Contracting Officer a Decision Gate Report that contains (i) sufficient detail, documentation and analysis to support successful completion of the stage according to the predetermined qualitative and quantitative criteria that were established for Go/No Go decision making; and (ii) a description of the next stage of product development to be initiated and a request for approval to proceed to the next stage of product development.

2.1.11

Risk Management Plan: The Contractor shall develop a risk management plan within 90 days of contract award highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant WBS elements where appropriate. Updates to this plan shall be included every three months (quarterly) in the monthly Project Status Report.

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2.1.12

Performance Measurement Baseline Review (PMBR): The Contractor shall submit a plan for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as FOLLOWS:

I.	Jointly assess areas such as the Contractor's planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks

II.	Confirm the integrity of the Performance Measurement Baseline (PMB)

III.	Foster the use of EVM as a means of communication

IV.	Provide confidence in the validity of Contractor reporting

V.	Identify risks associated with the PMB

VI.	Present any revised PMBs for mutual agreement

VII.

Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/).

VIII.	Present the Risk Management Plan

2.1.13

Deviation Request: During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor shall submit a Deviation Report. This report shall request a change in the agreed-upon IMS and timelines. This report shall include: (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.

2.1.14	Monthly and Annual Reports: The Contractor shall deliver Project Status Reports on a monthly basis. The reports shall address the items below cross referenced to the WBS, SOW, IMS, and EVM:

I.	Executive summary highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory;

II.	Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps;

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III.	Updated IMS;

IV.	Updated EVM;

V.	Updated Risk Management Plan (Every 3 months);

VI.	Three month rolling forecast of planned activities;

VII.	Progress of regulatory submissions;

VIII.	Estimated and actual expenses;

2.1.15	Data Management: The Contractor shall develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all contract data;

2.1.15.1	Provide for the statistical design and analysis of data resulting from the research;

2.1.15.2	Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request.

2.2.1	N/A (no scope)

2.3.1	Develop and validate [...***...] to lower [...***...].

2.3.2	[...***...]: Conduct [...***...] studies including [...***...] studies, [...***...] studies in [...***...].

2.3.3	[...***...]

2.3.3.1	Conduct [...***...study in [...***...].

2.3.3.2	Conduct [...***...] studies including [...***...studies, [...***...] studies including [...***...] CMX-001 and [...***...] in [...***...].

2.3.4	Use of [...***...] as a CMX-001 Surrogate in [...***...] Studies.

2.3.4.1	Dose [...***...] with [...***...] to identify the concentration of the [...***...] in [...***...] associated with [...***...] of [...***...].

2.3.5	Scaling of [...***...] to [...***...] by conducting studies with [...***...] to determine [...***...] in [...***...].

2.3.6	[...***...] of CMX001, [...***...] and [...***...] in the [...***...].

2.3.7	Conduct [...***...] experiments to demonstrate [...***...] following effective [...***...] prior to [...***...].

2.3.8	Conduct studies to [...***...] in [...***...].

2.3.9	Conduct CMX001 [...***...] study in [...***...] at a dose of CMX001 equivalent or less than [...***...] with treatment beginning at the [...***...]

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2.4.1	Measurement of [...***...] levels in [...***...] and correlate the [...***...] levels to studies conducted in [...***...].

2.4.2	Conduct expanded access protocol ([...***...]).

2.4.3	Analyze data and provide a Final Report for [...***...] evaluation of CMX001 in patients ([...***...])

2.5.1	Engaging the FDA on a path to support the treatment of smallpox indication with CMX-001

2.5.2	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA and/or all other data packages;

2.5.3	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final minutes of any informal meeting with the FDA;

2.5.4	Obtain FDA concurrence on the feasibility of the proposed [...***...]CMX001/CDV/[...***...] in the [...***...], including FDA feedback on [...***...] and review of data for the first [...***...] enrolled in the [...***...] sub-study

2.5.5	Develop and submit a revised [...***...] for CMX001 for Treatment of Smallpox, [...***...] for FDA review and comment, and revise the [...***...] as requested by FDA

2.6.1	Validation of the [...***...] process: Validation of the process to demonstrate the [...***...] of a [...***...] of acceptable quality will be performed.

2.6.2	Validation of the [...***...] process to produce [...***...]: Validation of the process to demonstrate the [...***...] of a [...***...] of acceptable quality will be performed.

3.	PHASE II: [...***...]

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3.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

3.2.1	N/A (no scope)

3.3.1	Quantify [...***...] concentrations in [...***...] from [...***...].

3.3.2	Determine [...***...] for CMX001 [...***...] in [...***...].

3.3.3	Scaling of [...***...] to [...***...] - Review with BARDA and FDA the [...***...] generated to support scaling between [...***...] and [...***...] using [...***...] as well as comparisons of [...***...] in the [...***...].

3.3.4	Determine [...***...] for CMX001 in [...***...] in [...***...].

3.3.5	Conduct [...***...].

3.3.6	Conduct [...***...] and [...***...] of [...***...]

3.3.7	Chimerix will provide [...***...] for the [...***...] and [...***...] conducted under the [...***...]

3.4.1	N/A (No scope)

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3.5.1	Engaging the FDA on a path to support the treatment of smallpox indication with CMX001

3.5.2	Generating all necessary documentation for [...***...]. [[...***...]]

3.5.3	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA (if needed) and/or all other data packages;

3.5.4	Providing BARDA with (1) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to the smallpox program; (ii) final draft minutes of any informal meeting with the FDA relating to the smallpox program.

3.6.1	N/A (No scope)

4.	PHASE III: [...***...]

4.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

4.2.1	N/A (no scope)

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4.3.1

[...***...] studies: A [...***...] study will be conducted with the [...***...] of CMX001 selected based on the results of the [...***...] and [...***...] studies, [...***...] will be [...***...] to [...***...] beginning at the [...***...] or the FDA agreed upon trigger for treatment. The first [...***...] study will be a [...***...] study of CMX001 in the [...***...] model. A study will be conducted with an [...***...] of CMX001 to determine the [...***...] after observation of the FDA agreed upon trigger for treatment. These studies will include [...***...] and [...***...]. The primary endpoint will be [...***...].

4.3.2

[...***...] study of CMX001 in the [...***...]: The [...***...] study will evaluate the [...***...] of CMX001 at [...***...]. The study will include [...***...] and [...***...] agreed upon with the FDA. The primary endpoint will be [...***...]. A [...***...] study to measure [...***...] in the selected [...***...] will be conducted to confirm the [...***...]. A [...***...] study will be conducted prior to [...***...] in the [...***...] to determine [...***...] and [...***...]..

4.3.3	Conduct additional studies, including [...***...], in [...***...] to determine [...***...] and [...***...] for CMX001 at [...***...]

4.3.4	Conduct [...***...] of [...***...]

4.3.5	Conduct additional studies for [...***...] of [...***...] to be used in [...***...]

4.3.6	Conduct additional [...***...] studies using [...***...].

4.4.1	Clinical [...***...] studies to evaluate [...***...] used in previous clinical studies and [...***...] used in previous clinical studies and [...***...]. This study will [...***...] to [...***...] to determine if [...***...] are comparable.

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4.5.1	Generating all necessary data and preparing documentation for an [...***...] meeting submission to regulatory agencies;

4.5.2	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including the [...***...] Meeting, meetings to review [...***...], EUA (if needed) and/or all other data packages;

4.5.3	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to this Contract; (ii) final draft minutes of any informal meeting with the FDA;

4.5.4	Preparing an [...***...] submission for a [...***...]

4.6.1	[...***...] in order to [...***...] for registration and clinical trial supplies

4.6.2	[...***...]. Validation of the process to demonstrate the [...***...] of a [...***...] of acceptable quality will be performed.

5.	PHASE IV: [...***...]

5.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

5.2.1	N/A (no scope)

5.3.1	[...***...]. A [...***...] study will be conducted with [...***...] and [...***...] subject to FDA feedback. [...***...] will be randomized to [...***...] beginning at the [...***...or the FDA agreed upon trigger for treatment. These studies will include [...***...] and [...***...]. The primary endpoint will be [...***...].

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5.4.1	N/A (No scope)

5.5.1	Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;

5.5.2	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, NDA and/or all other data packages relating to this Contract;

5.5.3	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft minutes of any informal meeting with the FDA relating to this Contract

5.6.1	[...***...]. [...***...] of the process to demonstrate the [...***...] of the [...***...] of acceptable quality will be performed at new manufacturing site either at [...***...] or [...***...]. May include a [...***...] and [...***...], the [...***...] to support the [...***...], and [...***...] of required necessary [...***...] to support [...***...].

6.	PHASE V: [...***...]

6.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

6.2.1	N/A (no scope)

6.3.1	[...***...] Studies. This study replicates [...***...] if a larger sample size is necessary to achieve a [...***...] result.

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6.4.1	Compile [...***...]. A database of [...***...] collected from all CMX001 clinical studies, irrespective of [...***...], will be populated and analyzed in order to support an NDA for smallpox.

6.5.1	Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;

6.5.2	Submitting NDA documentation to the FDA in a timely manner, consistent with timelines set out in the contract and by the FDA.

6.5.3	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, EUA and/or all other data packages;

6.5.4	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft minutes of any informal meeting with the FDA;

6.6.1	[...***...]. [...***...] of the process to demonstrate the [...***...] of a [...***...] will be performed.

7.	Other Items

7.1.1	The [...***...] and use of [...***...];

7.1.2	The acquisition, handling, storage and shipment of [...***...], including [...***...] required for working with the [...***...];

7.1.3	The [...***...] of [...***...] under cGMP;

7.1.3.1	The design and conduct of [...***...]; and

7.1.3.2	The conduct of [...***...] studies to determine [...***...] of [...***...]

7.1.4	Design and conduct of [...***...] under GCP.

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2.	Renewal Option.

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TENANT:	CHIMERIX, INC.,

1.	Registration Statement (Form S-8 No. 333-187860) pertaining to the 2002 Equity Incentive Plan, 2012 Equity Incentive Plan, 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc.,

2.	Registration Statement (Form S-8 Nos. 333-194408, 333-202582, 333-209802 and 333-216396) pertaining to the 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc., and

3.	Registration Statement (Form S-3 No. 333-221412) of Chimerix, Inc.;