o	Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

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Item 1.	BUSINESS

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•	a robust inherent immune response that harnesses the human body's naturally protective and rapid immune reaction to the alpha-Gal carbohydrate as a mechanism to fight cancer;

•	a complex targeted approach that is multi-faceted and involves combined antibody-mediated and multi-cellular responses; and

•	an allogeneic, tumor-specific, but not patient specific, approach, in which we manufacture products from genetically modified, allogeneic cells from previously established cell lines, which permits an easier scale-up of the manufacturing process compared to an autologous, or patient specific, approach involving a patient's own cells.

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•	Algenpantucel-L is currently being studied in two Phase 3 clinical trials for patients with pancreatic cancer:

▪	IMPRESS (IMmunotherapy for Pancreatic REsectable cancer Survival Study)

▪	PILLAR (Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable disease)

•	Tergenpumatucel-L is being investigated in a Phase 2b clinical trial for patients with advanced non-small cell lung cancer (NSCLC) and is also under investigation in a Phase 1/2 clinical trial evaluating the combination of tergenpumantucel-L with indoximod and docetaxel for patients with advanced NSCLC

•	Dorgenmeltucel-L is being investigated in a Phase 2 clinical trial for patients with advanced melanoma

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•	Potential to break immune tolerance. The immune tolerance to cancerous cells represents a key barrier to the treatment of cancer. To date, there are several available therapies that have addressed the immune escape mechanisms of cancer. We believe inhibition of the IDO pathway has the potential to break a key immune escape mechanism of cancer cells and significantly enhance patient outcomes.

•	Tolerability. In early-stage clinical development, we have observed an encouraging safety profile. We believe inhibition of the IDO pathway will selectively enhance the immune response against cancer cells given the limited expression of IDO in normal cells.

•	Oral bioavailability. Unlike many cancer therapies which require intravenous administration, our IDO pathway inhibitors are orally bioavailable, a significant advantage in ease of administration for patients and physicians.

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Synergy with existing cancer therapies. Inhibiting the IDO pathway in conjunction with immunotherapy or chemotherapy has the potential to enhance the therapeutic effect of these agents. Used in combination with chemotherapy IDO inhibitors have the potential to delay or disrupt the reacquisition of immune tolerance to tumor antigens during the period following chemotherapy. In addition, preclinical studies have demonstrated the synergistic potential of IDO pathway inhibitors in combination with other cancer immunotherapies, including other checkpoint pathway inhibitors as well as cancer vaccines. The safety profile in humans is conducive to exploring combination therapy and the available animal data does not indicate significant additive or synergistic toxicities with many common oncology therapies.

•	Complete the Phase 3 clinical trials of algenpantucel-L, our lead HyperAcute Cellular Immunotherapy product candidate, and gain regulatory approval.

•	Build commercial infrastructure to support a successful product launch of algenpantucel-L in the United States and establish commercial collaborations in other regions.

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•	Expand current manufacturing capabilities to establish adequate supply for anticipated commercial demand and future clinical development for algenpantucel-L.

•	Establish validated external manufacturing capacity for algenpantucel-L and potential subsequent HyperAcute Cellular Immunotherapy products.

•	Seek an expanded indication for algenpantucel-L to include the treatment of patients with locally advanced pancreatic cancer.

•	Advance our tergenpumatucel-L and dorgenmeltucel-L product candidates through additional clinical trials.

•	Further develop our proprietary IDO pathway inhibitor indoximod.

•	Support the strategic alliances with Genentech and Merck.

•	Strengthen our pipeline of immune stimulatory drug candidates, including both our oncology and our infectious disease targets.

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Toxicity. Chemotherapeutic agents are highly toxic to the human body and often cause a variety of side effects, which may include nausea and vomiting, bleeding, anemia and mucositis. Targeted therapeutics may have fewer systemic toxicities, but still tend to have off-target effects such as gastrointestinal inflammation, severe skin reactions and breathing difficulties. These effects limit a patient's ability to tolerate treatment thereby depriving the patient of the potential benefit of additional treatments or treatment combinations that might otherwise destroy or prevent the growth of cancer cells. Once educated as to the limited efficacy, limited increased survival and potentially significant toxicity of existing treatment alternatives, patients diagnosed with terminal cancer often choose to limit or forego therapy in order to avoid further compromising their quality of life. Patients with advanced stage cancer often cannot tolerate cancer therapy, and certain therapies have been shown to hasten death in some cases as the patient's health deteriorates.

•	Development of resistance. While many current therapeutic approaches may be effective against a particular target, the overall impact of these therapies on treating cancer is limited because the abundance and diversity of tumor cells are believed to enable cancers to adapt and become resistant to these treatments over time resulting in reduced longer-term efficacy.

•	Short-term approach. Incremental survival benefit is the primary objective of many currently marketed and development-stage cancer therapeutics. In general, many drugs show modest impact on overall survival or only affect progression-free survival. Other than surgical tumor removal, curative intent is often not a focus or realistic potential outcome of many current cancer therapies.

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Immune system suppression. Cancer is difficult to treat in part because cancer cells use sophisticated strategies to evade the immune system. Current approaches to cancer treatment generally involve introduction of an agent, such as a chemical, an antibody or radiation. These agents cause cell apoptosis (programmed cell death) or inhibit the proliferation of all cells, including immune cells, thereby indirectly suppressing the immune system. A weakened immune system not only further inhibits the body's natural ability to fight cancer, but also causes patients to become more susceptible to infections and other diseases.

•	Robust, innate immune response. Our HyperAcute Cellular Immunotherapy technology is designed to fight cancer by activating the human body's naturally protective and rapid immune response to the alpha-Gal carbohydrate.

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Complex, multi-targeted approach. We believe our HyperAcute Cellular Immunotherapy technology attacks cancer through several mechanisms. Initially, by introducing allogeneic, whole cancer cells incorporating alpha-Gal to the body, our HyperAcute Cellular Immunotherapy is designed to educate the immune system to attack specific cancer cells, such as pancreas, lung or melanoma cancer cells, with both antibody mediated and cellular immune responses. Secondly, by using multiple whole cancer cell lines, our HyperAcute Cellular Immunotherapy targets multiple tumor proteins simultaneously, which we believe increases the probability of stimulating an effective immune response to the heterogeneous cells that are present in cancer.

•	Favorable safety profile. We have not observed significant additional systemic toxicities when HyperAcute Cellular Immunotherapy has been added to standard chemotherapy or radiation regimens. Our HyperAcute Cellular Immunotherapy technology is designed to stimulate a strong or robust immune response to specific cancer cells while limiting the risks of off-target effects.

•	Broad applicability. We believe that the novel mechanism of action, good tolerability and favorable safety profile will enable our HyperAcute Cellular Immunotherapy product candidates to have potential benefits across multiple disease stages and tumor types and in combination with other therapies.

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•	IMPRESS (IMmunotherapy for Pancreatic REsectable cancer Survival Study)

•	PILLAR (Pancreatic Immunotherapy with Algenpantucel-L for Locally Advanced non-Resectable)

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*	Disease-free survival at one year was not reported. However, from the median disease-free survival of 11.4 months, we have inferred that disease-free survival at one year is less than 50%.

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Nodal status: refers to the presence of cancer in the nearby lymph nodes. When cancer enters the lymph nodes, there is an increased risk that the cancer will spread, or metastasize, to other regions of the body via the lymphatic system. As such, nodal status is an indicator of disease progression and thereby a prognostic indicator of survival. A study completed by Hsu et al. and published in the Annals of Surgical Oncology in 2010 reported that resected pancreatic cancer patients who received adjuvant chemoradiotherapy with positive lymph nodes prior to resection had a median overall survival 8.5 months less than that of patients with negative nodes. Further, a study conducted by Lim et al. published in Annals of Surgery in 2003 demonstrated that patients with greater than four positive lymph nodes had median overall survival 9.4 months less than that of patients with no positive lymph nodes.

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Degree of local invasion: refers to the extension of tumors into peripancreatic tissues including neural, vascular, or lymphatic structures or surrounding organs. Larger, higher-staged tumors are associated with a higher degree of local invasion, advanced disease and a poorer prognosis. As it relates to pancreatic cancer, patients with smaller, less invasive tumors have a greater median overall survival as reported by Gebhardt et al. in Langenbeck's Archives of Surgery in 2000. In the Gebhardt study, patients with pancreatic cancer that had invaded the lymph vessels, blood vessels and perineural tissues had a median overall survival of 16.8 months, 7.2 months and 4.8 months less, respectively, than patients with cancer that had not invaded these tissues.

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Tumor stage: refers to the size and peripancreatic extension of pancreatic cancer. T1 is defined as less than two centimeters in diameter and limited to the pancreas; T2 is defined as greater than two centimeters in diameter and limited to the pancreas; T3 is defined as a tumor that has extended beyond the pancreas; and T4 tumors are defined as unresectable. The T3 tumor stage is associated with poorer prognosis and increased risk of death compared to T1-T2 tumors in resected pancreatic cancer patients who receive adjuvant chemoradiotherapy as reported by Hsu et al., where T3 patients had a median overall survival that was 8.3 months less than T1-T2 patients.

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Tumor grade: refers to abnormalities of cancer cells relative to healthy cells. Tumor cells considered undifferentiated, or having a higher tumor grade, have little to no resemblance to the cells from which they originated (in this case pancreatic cells). Tumors classified as G1 or G2 are considered low grade tumors with well and moderately differentiated cells, respectively. Tumors classified as G3 or G4 are considered high grade tumors with poorly or undifferentiated cells, respectively. Many factors are considered in determining tumor grade, including the structure and growth pattern of the cells. Tumor grade is determined by a pathologist via biopsy of the tumor. Higher degrees of cancer cell abnormality are associated with a poorer disease prognosis; in fact, high tumor grade is an independent predictor of survival. The study conducted by Lim et al. referred to above showed that patients with poorly differentiated (G3), or higher grade, tumors of the pancreas had median overall survival of 22.8 months less than patients with well differentiated (G1), or lower grade, tumors.

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Ca 19-9 markers: refers to the post-operative concentration of the tumor marker carbohydrate antigen 19-9. The concentration of Ca 19-9 markers is associated with significant risk of early, distant metastasis. A study conducted by Kinsella et al. published in American Journal of Clinical Oncology in 2008 reported that pancreatic cancer patients with high post-operative Ca 19-9 levels, defined as greater than 70 units per milliliter, had a median overall survival 16.8 month less than patients with Ca 19-9 marker levels lower than 70 units per milliliter.

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(1)	Regine et al., JAMA 2008; 299(9): 1019-1026.

(2)	Includes only the 124 patients who tested positive for the Lewis antigen (patients who test negative for the antigen do not express Ca 19-9).

(3)	Regine et al. study in JAMA only reports overall survival and disease-free survival for patients with pancreatic head tumors. The median overall survival of patients in the standard-of-care treatment arm of RTOG 97-04 is 18.8 months.

(4)	Hardacre JM, mulcahy KA, Small EJ, et al: Addition of Algenpantucel-L Immunotherapy to Standard Adjuvant Therapy for Pancreatic Cancer: a Phase 2 Study J Gastrointest Surg DOI 10.1007/s11605-012-2064-6, 2012.

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(1)	Prospective Randomized Trial of Docetaxel versus Best Supportive Care in Patients with Non-Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy. Shepherd et al., Journal of Clinical Oncology, Volume 18, No. 10 (May), 2000: pp 2095-2103

(2)	Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients with Non-Small-Cell Lung Cancer Previously Treated with Chemotherapy. Hanna et al., Journal of Clinical Oncology 2004 May 1; 22(9):1589-97

(3)	Data from NLG-0101 tergenpumatucel-L clinical trial, Patients 18-45

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•	NLG2101 Phase 2 clinical trial of indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer was fully enrolled as of the end of 2015. We expect to report additional progress in 2016.

•	NLG2102 Phase 1b/2 clinical trial of indoximod in combination with temozolomide for patients with refractory malignant brain tumors.

◦	Phase 1b portion results were reported in 2015 and confirmed the combination has an acceptable safety profile and demonstrated preliminary clinical activity of the combination therapy.

◦	Phase 2 portion is currently enrolling. We expect to report additional progress in 2016.

•	NLG2103 Phase 1b/2 clinical trial of indoximod in combination with ipilimumab for patients with advanced melanoma.

◦	Phase 1b portion results were reported in 2015 and confirmed the combination has an acceptable safety profile.

•	NLG2014 Phase 1b/2 clinical trial of indoximod in combination with gemcitabine or nab-paclitaxel for patients with metastatic pancreatic cancer.

◦	Phase 1b portion results were reported in 2016 and confirmed the combination has an acceptable safety profile and demonstrated preliminary clinical activity.

•	NLG2105 Phase 1 clinical trial of indoximod in combination with temozolomide for pediatric patients with refractory malignant brain tumors.

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•	that we will be the first to obtain approval for any other drugs or indications for which we obtain Orphan Drug designation;

•	that Orphan Drug designation will result in any commercial advantage or reduce competition; or

•	that the limited exceptions to this exclusivity will not be invoked by the FDA.

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•	we may experience delays or failure in reaching agreement on acceptable clinical trial contracts or clinical trial protocols with prospective sites;

•	regulators or institutional review boards may not authorize us to commence a clinical trial;

•	regulators or institutional review boards may suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or concerns about patient safety;

•	we may suspend or terminate our clinical trials if we believe that they expose the participating patients to unacceptable health risks;

•	our clinical trials may have slower than expected patient enrollment or lack of a sufficient number of patients that meet their enrollment criteria;

•	patients may not complete clinical trials due to safety issues, side effects, dissatisfaction with the product candidate, or other reasons;

•	we may experience difficulty in maintaining contact with patients after treatment, preventing us from collecting the data required by our clinical trial protocol;

•	product candidates may demonstrate a lack of efficacy during clinical trials;

•	we may experience governmental or regulatory delays, failure to obtain regulatory approval or changes in regulatory requirements, policy and guidelines;

•	enrollment in and conduct of our clinical trials may be adversely affected by competition with ongoing clinical trials and scheduling conflicts with participating clinicians; and

•	we may experience delays in achieving clinical trial endpoints and completing data analysis for a trial.

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•	design of the trial protocol;

•	size of the patient population;

•	eligibility criteria for the clinical trial in question;

•	perceived risks and benefits of the product candidate under study;

•	changes in the standard of care that make the trial as designed less attractive to clinicians and patients;

•	availability of competing therapies and clinical trials;

•	efforts to facilitate timely enrollment in clinical trials;

•	patient referral practices of physicians;

•	ability to monitor patients adequately during and after treatment; and

•	proximity and availability of clinical trial sites for prospective patients.

•	a product candidate may not be considered safe or effective;

•	our manufacturing processes or facilities may not meet the applicable requirements; and

•	changes in their approval policies or adoption of new regulations may require additional work on our part.

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•	deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;

•	inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

•	the product candidate may have unforeseen adverse side effects;

•	the time required to determine whether the product candidate is effective may be longer than expected;

•	fatalities or other adverse events arising during a clinical trial due to medical problems that may not be related to clinical trial treatments;

•	failure to demonstrate a benefit from using a drug;

•	the quality or stability of the product candidate may fall below acceptable standards; or

•	insufficient quantities of the product candidate to complete the trials.

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•	our preclinical testing may produce inconclusive or negative safety results, which may require us to conduct additional preclinical testing or to abandon product candidates that we believed to be promising;

•	our product candidates may have unfavorable pharmacology, toxicology or carcinogenicity;

•	our product candidates may cause undesirable side effects; and

•	the FDA or other regulatory authorities may determine that additional safety testing is required.

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•	train, manage and motivate a growing employee base;

•	accurately forecast demand for our products; and

•	expand existing operational, financial and management information systems.

•	our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

•	the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe any future products;

•	the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

•	unforeseen costs and expenses associated with creating an independent sales and marketing organization.

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•	the FDA may not approve our facilities or the facilities used by, or the manufacturing processes developed by, us or WuXi or other manufacturers, or the FDA may impose additional requirements that result in unforeseen expense or delay;

•	we have no experience managing relationships with commercial manufacturing organizations, and we may make decisions in connection with our relationship with other manufacturers that result in unforeseen delays, expenses or other difficulties, or that later prove to be less advantageous than other decisions we could have made;

•	we or such other manufacturers may encounter unforeseen difficulties in attempting to manufacture biological materials related to algenpantucel-L at a larger scale than we have previously attempted;

•	other manufacturers may not be able to devote sufficient resources or facilities to manufacture cell materials in the quantities we may require;

•	the manufacturing processes may produce low or variable quality or quantities of manufactured cell materials, and we may expend considerable resources attempting to identify or remedy factors causing such problems, or we may not be able to identify or remedy such factors;

•	WuXi is currently our sole contract manufacturer for cell materials, and any unforeseen difficulties or work slow down or stoppage resulting from economic, labor, governmental, political or environmental factors, among others, may result in increased costs or delay, or a reduction or elimination of WuXi’s ability to manufacture cell material for algenpantucel-L; and

•	the FDA may not approve algenpantucel-L for the treatment of patients with surgically resected pancreatic cancer, or any subset of such patients, which would not relieve our obligation for certain costs under the WuXi Agreement or other such agreements, if any.

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•	civil or criminal penalties;

•	injunctions;

•	suspension of or withdrawal of regulatory approval;

•	total or partial suspension of any ongoing clinical trials or of production;

•	voluntary or mandatory product recalls and publicity requirements;

•	refusal to approve pending applications for marketing approval of new products or supplements to approved applications filed by us;

•	restrictions on operations, including costly new manufacturing requirements; or

•	seizure or detention of our products or import bans.

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The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or in return for purchasing, leasing, ordering, or arranging for the purchase, lease, or order of any health care item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Moreover, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

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The federal False Claims Act prohibits any person or entity from knowingly presenting, or causing to be presented, to the federal government a claim for payment or approval that is false or fraudulent or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. Recently, several pharmaceutical and other health-care companies have been prosecuted under these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have been prosecuted for causing false claims to be submitted because of off-label promotion. Private parties may initiate qui tam whistleblower lawsuits against any person or entity under the False Claims Act in the name of the government and share in the proceeds of the lawsuit.

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The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization on covered entities, such as health plans, healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information.

•	The federal Food, Drug and Cosmetic Act, or FDCA, prohibits, among other things, the adulteration or misbranding of drugs and medical devices.

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The federal Physician Payments Sunshine Act, and its implementing regulations require manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the Centers for Medicare and Medicaid Services information related to payments and other transfers of value to physicians, other healthcare providers, and teaching hospitals, as well as ownership and investment interests held by physicians and other healthcare providers and their immediate family members.

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Analogous state laws and regulations include: 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 any third-party payer, 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 U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information and that require tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

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•	the scope, rate of progress, results and costs of our preclinical studies, clinical trials and other research and development activities;

•	the scope, rate of progress and costs of our manufacturing development and commercial manufacturing activities;

•	the cost, timing and outcomes of regulatory proceedings (including FDA review of any BLA or NDA we file);

•	payments required with respect to development milestones we achieve under our in-licensing agreements;

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•	the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims, including litigation costs and the outcome of such litigation;

•	the costs associated with commercializing our product candidates, if they receive regulatory approval;

•	the cost of manufacturing our product candidates and any products we commercialize;

•	the cost and timing of developing our ability to establish sales and marketing capabilities;

•	the potential requirement to repay our outstanding government provided loans;

•	competing technological efforts and market developments;

•	changes in our existing research relationships;

•	our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;

•	the timing and receipt of revenues from existing or future products, if any; and

•	payments received under any future strategic collaborations.

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•	the collaborator may not apply the expected financial resources, efforts or required expertise in developing the physical resources and systems necessary to successfully commercialize the subject potential product;

•	the collaborator may not invest in the development of a sales and marketing force and the related infrastructure at levels that ensure that sales of the potential product reach their full potential;

•	disputes may arise between us and a collaborator that delay the commercialization or adversely affect its sales or profitability of the potential product; or

•	the collaborator may independently develop, or develop with third parties, products that could compete with the potential product.

•	we may be required to undertake the expenditure of substantial operational, financial and management resources;

•	other than under the Genentech Agreement and the Merck Agreement, we may be required to issue equity securities that would dilute our existing stockholders’ percentage ownership;

•	we may be required to assume substantial actual or contingent liabilities;

•	we may not be able to control the amount and timing of resources that our strategic collaborators devote to the development or commercialization of our product candidates;

•	strategic collaborators may delay clinical trials, provide insufficient funding, terminate a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new version of a product candidate for clinical testing;

•	strategic collaborators may not pursue further development and commercialization of products resulting from the strategic collaboration arrangement or may elect to discontinue research and development programs;

•	strategic collaborators may not commit adequate resources to the marketing and distribution of our product candidates, limiting our potential revenues from these products;

•	disputes may arise between us and our strategic collaborators that result in the delay or termination of the research,

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•	strategic collaborators may experience financial difficulties;

•	strategic collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in a manner that could jeopardize or invalidate our proprietary information or expose us to potential litigation;

•	business combinations or significant changes in a strategic collaborator’s business strategy may also adversely affect a strategic collaborator’s willingness or ability to complete its obligations under any arrangement;

•	strategic collaborators could decide to move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and

•	strategic collaborators could terminate the arrangement or allow it to expire, which would delay the development and may increase the cost of developing our product candidates.

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•	decreased demand for our product;

•	injury to our reputation and significant negative media attention;

•	withdrawal of clinical trial volunteers;

•	costs of litigation;

•	distraction of management; and

•	substantial monetary awards to plaintiffs.

•	new products, product candidates or new uses for existing products introduced or announced by our strategic collaborators, or our competitors, and the timing of these introductions or announcements;

•	actual or anticipated results from and any delays in our clinical trials, including our Phase 3 IMPRESS clinical trial of algenpantucel-L, as well as results of regulatory reviews relating to the approval of our product candidates;

•	variations in the level of expenses related to any of our product candidates or clinical development programs, including those relating to the timing of invoices from, and other billing practices of, our clinical research organizations and clinical trial sites;

•	expenses related to, or our ability or perceived ability to secure, an adequate supply of any future products approved for commercial sale;

•	the results of our efforts to discover, develop, acquire or in-license additional product candidates or products;

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

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

•	the commercial or clinical success or failure, or perceived success or failure, of our collaborators, including Genentech and Merck;

•	additions or departures of key scientific or management personnel;

•	conditions or trends in the biotechnology and biopharmaceutical industries;

•	media attention, or changes in media attention, given to cancer and cancer treatment, the recent Ebola epidemic and efforts to develop treatments and vaccines for Ebola, or any other condition or disease that our product candidates are being developed to treat;

•	actual or anticipated changes in earnings estimates, development timelines or recommendations by securities analysts;

•	actual and anticipated fluctuations in our quarterly operating results;

•	the financial projections we may provide to the public, and any changes in these projections or our failure to meet these projections;

•	deviations from securities analysts’ estimates or the impact of other analyst rating downgrades by any securities analysts who follow our common stock;

•	other events or factors, including those resulting from political uncertainty, war, incidents of terrorism, natural disasters or responses to these events;

•	changes in accounting principles;

•	discussion of us or our stock price by the financial and scientific press and in online investor communities;

•	general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies; and

•	sales of common stock by us or our stockholders in the future, as well as the overall trading volume of our common stock.

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•	the division of our Board of Directors into three classes with staggered, three-year terms;

•	advance notice requirements for stockholder proposals and nominations;

•	the inability of stockholders to call special meetings;

•	limitations on the ability of stockholders to remove directors or amend our by-laws; and

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the ability of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder approval, which could include the right to approve an acquisition or other change in our control or could be used to institute a rights plan, also known as a poison pill, that would work to dilute the stock ownership of a potential hostile acquirer, likely preventing acquisitions that have not been approved by our Board of Directors.

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Item 1B.	UNRESOLVED STAFF COMMENTS

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Item 2.	PROPERTIES

Item 3.	LEGAL PROCEEDINGS

Item 4.	MINE SAFETY DISCLOSURES

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Item 5.	MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASE OF EQUITY SECURITIES

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Item 6.	SELECTED CONSOLIDATED FINANCIAL DATA

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Item 7.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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•	employee-related expenses, which include salaries, bonuses, benefits and share-based compensation;

•	the cost of acquiring and manufacturing clinical trial materials;

•	expenses incurred under agreements with contract research organizations, investigative sites and consultants that conduct our clinical trials and a substantial portion of our preclinical studies;

•	facilities, depreciation of fixed assets and other allocated expenses, which include direct and allocated expenses for rent and maintenance of research facilities and equipment;

•	license fees for and milestone payments related to in-licensed products and technology; and

•	costs associated with non-clinical activities and regulatory approvals.

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•	we expect our general and administrative expenses to increase as a result of increased payroll, expanded infrastructure and higher consulting, legal, auditing and tax services and investor relations costs; and director compensation;

•	we expect to incur increased general and administrative expenses to support our research and development activities, which we expect to expand as we continue to advance the clinical development of our product candidates; and

•	we expect to incur increased expenses related to the planned sales and marketing of our product candidates, which may include recruiting a specialty sales force, in anticipation of commercial launch before we receive regulatory approval, if any, of a product candidate.

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•	the scope, progress, results and costs of clinical trials for our product candidates, and discovery and development activities related to new product candidates;

•	the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates;

•	the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales, facilities, and distribution costs;

•	the cost of manufacturing our product candidates and any products we commercialize, including out costs under the WuXi agreement, whether or not a sufficient quantity of cell material is manufactured under that agreement;

•	our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;

•	whether, and to what extent, we are required to repay our outstanding government provided loans;

•	the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and

•	the timing, receipt and amount of sales of, or royalties on, our future products, if any.

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Item 7A.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Item 8.	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Item 9.	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Item 9A.	CONTROLS AND PROCEDURES

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Item 9B.	OTHER INFORMATION

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Item 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Item 11.	EXECUTIVE COMPENSATION

Item 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

Item 13.	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Item 14.	PRINCIPAL ACCOUNTING FEES AND SERVICES

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Item 15.	EXHIBITS, FINANCIAL STATEMENT SCHEDULES

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•	Incentive Stock Options

•	Nonstatutory Stock Options

•	Restricted Stock Awards

•	Stock Appreciation Rights

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(1)	During the third quarter of 2015, the Company corrected an immaterial error in the Company's 2014 income tax provision expense resulting in an increase to the Company's income tax expense and a decrease in net income of $6.8 million and a reduction of basic and diluted earnings per share for the three-month period ended December 31, 2014 of $0.25 and $0.22.

(2)

The Company identified an error relating to the basic and diluted loss per share amounts reported in Quarterly Financial Information Note to the Annual Report on Form 10-K for the year ended December 31, 2014 of $0.33 and $0.66 for the three-month periods ended June 30, 2014 and September 30, 2014, respectively. Management evaluated the impact of the error on the previously reported consolidated financial statements and notes and concluded the impact was not material. The Company has revised the per share amounts reported above to correctly report the quarter-to-date basic and diluted loss per share for these periods.

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RE:	ADDENDUM TO THE LEASE BETWEEN ISU RESEARCH PARK CORPORATION AND NEWLINK GENETICS CORPORATION DATED MARCH 1, 2010.

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RE:	ADDENDUM TO THE LEASE BETWEEN ISU RESEARCH PARK CORPORATION AND NEWLINK GENETICS CORPORATION DATED AUGUTST 22, 2005.

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1)

Work Orders. From time to time, Customer may submit to WuXi AppTec written work orders (“Work Orders”) for services (“Services”) to be performed by WuXi AppTec under this Agreement. Upon mutual agreement and execution of a Work Order by both Parties, the terms and conditions of this Agreement shall be incorporated into such Work Order (regardless of whether such Work Order contains language effecting such incorporation). For purposes of clarity, the terms of this Agreement shall be incorporated by reference into Work Order 4 and Work Order 5 between the Parties, both dated December 17, 2015.

2)	Product. “Product” covered under this Agreement means all or any part of the product manufactured (including any sample thereof), the particulars of which are listed in relevant Work Orders attached hereto.

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3)

Special / Custom Equipment. In the event special or custom equipment is required for the manufacture of Product, Customer shall provide WuXi AppTec with such equipment (the “Equipment”) to be used to manufacture the Product which Equipment is listed in the relevant Work Order attached hereto. The Equipment shall remain Customer’s property at all times and WuXi AppTec shall use the Equipment solely to perform the Services for Customer under this Agreement and the relevant Work Order and for no other purpose. WuXi AppTec shall maintain and keep the Equipment in proper working order and secure and safe from loss and damages. WuXi AppTec shall be liable to Customer for loss and damage to the Equipment while in its possession (ordinary wear and tear excepted). In the event that any item of Equipment reaches the end of such item’s useful life due to ordinary wear and tear from the performance of the Services hereunder, then upon request by WuXi AppTec, Customer shall at its option either repair or replace such item at its expense.

4)	Procurement, Processing and Packaging.

(a)

Customer shall provide WuXi AppTec with the [*] for WuXi AppTec to perform the Services and to manufacture the Product, and WuXi AppTec shall procure other starting materials, at [*] cost and as set forth in the relevant Work Order (together with the [*] provided by Customer, the “Starting Material”), for subsequent processing into Product in accordance with the Product Specifications (as defined below). Customer shall supply to WuXi AppTec with relevant information and full details of any hazards relating to Starting Material, their storage and use. Upon review of this information, the Starting Material and any Customer know-how, procedures and other relevant information necessary for WuXi AppTec to process Starting Material into Product shall be provided to (or procured by, as applicable) WuXi AppTec. All Starting Material delivered to WuXi AppTec shall be shipped by a reputable shipping company selected by [*] at WuXi AppTec’s facility in Philadelphia, Pennsylvania or such other location as the parties may agree from time to time (“WuXi AppTec Plant”). [*] shall bear all risk of loss prior to delivery at WuXi AppTec Plant. WuXi AppTec will inspect the Starting Material as soon as practical after receipt and promptly inform Customer of any damage or loss. Customer shall retain title to the Starting Materials at all times, but risk to undamaged Starting Material shall pass from [*] after [*]. WuXi AppTec shall maintain and keep Starting Materials secure and safe from loss and damage, and shall be liable to Customer for the replacement of any Starting Materials lost or damaged while [*]. [*] shall pay all shipping or similar charges (including insurance and tax, if any) applicable to [*] delivery of Starting Material pursuant to this Section 4(a).

(b)	Customer hereby grants WuXi AppTec the non-exclusive right to use the Starting Material and any Confidential Information supplied by Customer for the sole purpose of performing the Services for Customer under the Agreement and the relevant Work Order. WuXi AppTec hereby undertakes not to use the Starting Material or any Confidential Information of Customer for any other purpose.

(c)

WuXi AppTec may in its sole discretion amend or modify its SOP manual and or individual policies and procedures, except that WuXi AppTec shall not make any such changes that affect the specifications for the Services and Product outlined by Customer under this Agreement or set forth in the applicable Work Order without Customer’s express prior written consent, unless the changes are required by state / federal regulations, in which case WuXi AppTec shall promptly notify Customer of any such required change.

(d)

Customer agrees that its contracts and certification relating to the logistical screening and isolation of Starting Materials shall be in compliance with the current rules, regulations, standards, and interpretations of the Food and Drug Administration (the “FDA”) and agrees to use its [*] efforts to comply with any future changes in the rules, regulations, standards and interpretations of the FDA as appropriate.

(e)

WuXi AppTec shall: (i) perform the Services, including processing Starting Material provided by Customer into the Product, in accordance with all applicable laws and regulations (including without limitation cGMP), the terms of this Agreement and the applicable Work Order, including the Product specifications set forth in Work Orders or as agreed to in writing by the Parties and attached hereto under a separate Exhibit (the “Product Specifications”), which Product Specifications may be amended or modified by mutual written agreement of the Parties; (ii) package and label the Product in accordance with Section 7 below; and (iii) deliver the Product to Customer or such other location designated by Customer in accordance with Section 7 below. WuXi AppTec will process Starting Material into the Product in a timely manner as agreed upon by

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(f)

WuXi AppTec represents and warrants that (i) the Services will be performed in compliance with the terms and conditions of this Agreement, the applicable Work Order and all applicable laws and regulations (including without limitation cGMP); (ii) the Product delivered will comply with the Product Specifications; (iii) the Services performed by WuXi AppTec hereunder will not infringe or misappropriate any intellectual property rights of any third party. In the event that any Service or Product provided by WuXi AppTec fails to comply with any of the foregoing warranties, WuXi AppTec shall, at Customer’s election, promptly [*], or promptly [*]. Notwithstanding the foregoing, the parties acknowledge and agree that because of the [*] of the [*], there is no guarantee that a [*] and therefore WuXi AppTec shall not be responsible for [*], provided that (a) the [*] and (b) the Services and Products provided by WuXi AppTec otherwise comply with the foregoing warranties.

(g)	EXCEPT AS EXPRESSLY SET FORTH HEREIN, WUXI APPTEC MAKES NO PRODUCT WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THE SOLE AND EXCLUSIVE REMEDIES OF CUSTOMER FOR BREACH OF A PRODUCT WARRANTY SHALL BE [*].

(h)	WuXi AppTec shall not be liable for any claim of Product non-conformance or breach of warranty unless such claim us submitted in writing by Customer within [*] following the date of Services were completed or the date of the breach giving rise to such claim, whichever is later.

(a)	Product shall be delivered [*], which means (a) when WuXi AppTec [*] at [*] and (b) risk and title to Product pass to Customer upon [*]. Transportation of Product, whether or not under any arrangements made by [*] on behalf of [*], shall be made at the sole risk and expense of [*].

(b)

Unless otherwise agreed or set forth in the applicable Work Order, WuXi AppTec shall package and label Product for delivery in accordance with its standard operating procedures and in accordance with required shipping conditions. It shall be the responsibility of Customer to inform WuXi AppTec in writing in advance of any special packaging and labeling requirements for Product. All [*] costs and expenses of whatever nature incurred by WuXi AppTec in complying with such special requirements [*] shall be [*] the price for Services.

(c)	If [*], WuXi AppTec will [*] arrange the transportation of Product from WuXi AppTec Plant to the destination indicated by Customer together with insurance coverage for Product in transit at its invoiced value. All [*] costs and expenses of whatever nature incurred by WuXi AppTec, Inc. in arranging such transportation and insurance [*] shall be [*] the price for Services.

(d)

Where WuXi AppTec has made arrangements for the transportation of Product, Customer shall diligently examine the Product as soon as practicable after receipt. Notice of all claims (time being of the essence) arising out of: (1) Visible damage to or total or partial loss of Product in transit shall be given in writing to WuXi AppTec and the carrier within [*] of receipt by Customer; or (2) Non-delivery shall be given in writing to WuXi AppTec within [*] after the receipt by Customer of WuXi AppTec’s dispatch notice.

(e)	Customer shall make damaged Product and associated packaging materials available for inspection and shall comply with the reasonable requirements of any insurance policy covering the Product, for which notification has been given by WuXi AppTec to Customer. [*] shall offer [*] all reasonable assistance in pursuing any claims arising out of the transportation of Product.

(f)

Promptly following receipt of Product or any sample thereof, Customer may carry out any of the tests outlined or referred to in the Specifications. If such tests show that the Product fails to meet Specification, Customer shall have the right to reject such Product by giving WuXi AppTec written notice thereof within [*] from [*]. In addition, except where the shelf life of the Product has expired, Customer shall have the right to

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(a)	Customer shall pay the price in accordance with the price detailed in Work Orders attached hereto for Services that are performed in compliance with the Specifications or other agreed-upon terms.

(b)

Payment shall be made in accordance with Work Orders attached hereto. Unless otherwise indicated in writing by WuXi AppTec, all prices and charges are [*] of any applicable taxes, levies, duties and fees of whatever nature imposed by or under the authority of any government or public authority, which shall be paid by [*] (other than [*]). Undisputed payment must be made within [*] of receipt by Customer of a correct invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim of any nature.

(c)

In the event of a default of payment on due date: (1) Interest shall accrue on any amount overdue at the annual rate of [*] above the prime rate of interest published from time to time in the Wall Street Journal (or similar successor rate), interest to accrue on a day to day basis both before and after judgment; and (2) WuXi AppTec shall, at its sole discretion, and without prejudice to any other of its accrued rights, be entitled to terminate this Agreement under Section 11(a)(ii).

(a)	Customer shall, at its expense, obtain and maintain all permits, licenses, clearances and approvals from the FDA and other regulatory agencies as are necessary or appropriate for the distribution of the Products.

(b)

Each Party will notify the other Party promptly upon receipt of information indicating that any of the Products may be subject to a recall, field corrective action or other regulatory action with respect to a Product taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment (a “Remedial Action”). Customer shall be responsible for determining the necessity of conducting any Remedial Action and WuXi AppTec shall cooperate in gathering and evaluating such information as is reasonably necessary for Customer to make such determination. In the event Customer determines that a Remedial Action should be commenced or a Remedial Action is required by any governmental authority

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(c)

Each Party will comply with the applicable provisions of the Adverse Reaction Reporting systems, including the requirements of 21 CFR Part 1270, and each Party will cooperate with the other Party for the efficient compliance therewith. WuXi AppTec agrees to notify Customer promptly upon receipt from any customer of any complaint or Adverse Reaction Report relating to the Products. Customer shall investigate and WuXi AppTec shall reasonably cooperate in any investigation of such complaint or Adverse Reaction Report and Customer will keep WuXi AppTec reasonably informed regarding the findings from such investigation.

(a)

Customer shall indemnify and hold harmless WuXi AppTec, its officers, directors, agents and employees from and against any and all losses, costs, damages and/or expenses (including, without limitation, reasonable costs of counsel), incurred by any such indemnitee as a result of or in connection with any claim by any third party 1) for injury (physical, emotional, psychological or other) or death of any person or physical damage to any property arising out of [*], provided such claim, injury, death or property damage is not the result of WuXi AppTec's [*] or breach of this Agreement in carrying out its obligations under this Agreement or any Work Order, or 2) alleging WuXi AppTec’s [*], or Customer intellectual property rights that are [*], infringes any rights (including, without limitation, any intellectual or industrial property rights) vested in any third party (whether or not the Customer knows or ought to have known about the same). In the event a third party claim is asserted against WuXi AppTec for which indemnification is required hereunder, WuXi AppTec shall give Customer prompt written notice thereof. WuXi AppTec shall cooperate with Customer, at Customer’s cost and expense, in the defense of any such claim. Customer shall have the sole right to defend and/or settle such a claim, including selecting counsel of its choice. Costs, expenses and fees incurred by WuXi AppTec and as to which WuXi AppTec has a right of indemnification hereunder shall be periodically reimbursed by Customer as incurred.

(b)

WuXi AppTec shall indemnify and hold Customer harmless against all claims, actions, costs, expenses (including court costs and reasonable attorney’s fees) or other liabilities (collectively, “Losses”) whatsoever to, from or in favor of third parties, to the extent such Losses are caused or contributed by 1) WuXi AppTec’s performance of the Services (except to the extent resulting from WuXi AppTec’s use of [*]); 2) the [*] or breach of this Agreement of WuXi AppTec or any of its employees or agents in the performance of Services. WuXi AppTec’s liability to indemnify Customer shall be reduced to the extent that such Losses were caused or contributed to by the [*] or breach of this Agreement by Customer. In the event a third party claim is asserted against Customer for which indemnification is required hereunder, Customer shall give WuXi AppTec prompt written notice thereof. Customer shall cooperate with WuXi AppTec, at WuXi AppTec’s cost and expense, in the defense of any such claim. WuXi AppTec shall have the sole right to defend and/or settle such a claim, including selecting counsel of its choice. Costs, expenses and fees incurred by Customer and as to which Customer has a right of indemnification hereunder shall be periodically reimbursed by WuXi AppTec as incurred.

(c)

Both Parties shall maintain a separate policy or policies of insurance in the amount of at least [*] per occurrence and [*] in the aggregate for insuring against liability which may be imposed arising out of its acts or omissions to include: 1) comprehensive general liability providing coverage for personal injury, bodily injury, property damage; and 2) professional liability. In addition, Customer shall maintain Product Liability insurance in the aggregate of at least [*]. As soon as practicable following the execution of this Agreement, each Party shall cause its insurer(s) to list the other Party as an additional insured on the insurance policies required hereby and shall deliver to the other Party a certificate(s) of insurance Party evidencing the applicable coverage(s).

(d)	WuXi AppTec’s sole liability for any loss or damage suffered by Customer as a result of any breach of the Agreement or of any other liability of WuXi AppTec in respect of the Services conducted under this

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(e)	Except for losses or damages arising from breach of [*] obligations or from a Party’s gross negligence or willful misconduct neither Party shall be liable hereunder for any special, indirect, incidental, consequential or punitive damages, even if such Party shall have been advised of the possibility of such potential damages. .

(f)	The Parties hereto acknowledge that the limitations of liabilities set forth in this Section 9 reflect the allocation of risk set forth in this agreement and that the Parties would not enter into this agreement without these limitations of liability.

(a)

While this Agreement is in effect, and for a period of [*] years after the termination of the Agreement, neither Parties, their affiliates, or any directors, shareholders, officers, employees or agents of the foregoing (collectively, the “Affiliates”) shall use or divulge to anyone any Confidential Information of the other Party (as hereinafter defined), except: (i) as required in the course of performing the obligations hereunder, (ii) to attorneys, accountants and other advisors, (iii) with the express written consent of the Parties or (iv) as required by law (provided that such Party shall promptly notify the other Party of such required disclosure and shall reasonably assist such other Party to obtain a protective order limiting or restricting the required disclosure). In addition, Customer shall have the right to disclose and use WuXi AppTec’s Confidential Information to the extent necessary or useful for its development, commercialization or other exploitation of the Product or other results or deliverables of the Services. The term “Confidential Information” of a Party shall mean any information relating to such Party or its business which is, (1) disclosed to the other (or to the other's Affiliates) during the negotiation of and performance of this Agreement and (2) is marked “Confidential” if provided in writing, or if delivered verbally, is reduced to writing within [*] and marked “Confidential.” In addition, all Data and Inventions (as defined below) shall be deemed Customer’s Confidential Information. “Confidential Information” shall not include any information which (i) becomes public knowledge without breach by the other of this Agreement; (ii) is obtained by the other (or the other's Affiliates) from a person or business entity under circumstances permitting its disclosure to others; (iii) may be demonstrated to have been known at the time of receipt thereof as evidenced by tangible records. If a party makes a disclosure of Confidential Information, which is permitted by the terms of this Agreement, such party shall be responsible for ensuring that the person to whom it is disclosed maintains the confidentiality of such Confidential Information in accordance with the terms of this Agreement.

(a)	Term. This Agreement shall become effective as of the Effective Date and will expire on the later of (i) [*] years from the Effective Date or (ii) the completion of all Services under the last Work Order executed by the parties prior to the [*] anniversary of the Effective Date. The Agreement may be extended by mutual agreement of the parties or earlier terminated in accordance with Section 11.

(b)

Customer has the right to terminate this Agreement or any Work order for any reason or no reason by delivery of written notice of such termination to WuXi AppTec effective [*] following delivery of such notice. In addition, each Party has the right to terminate this Agreement by delivery of written notice of such termination to the other Party effective immediately upon the receipt of such notice, upon the occurrence of any of the following events:

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(c)	Upon any termination or expiration of this Agreement, WuXi AppTec shall promptly return to Customer all Equipment, remaining Starting Material, all Product and other deliverables (in whatever stage of development) and all Confidential Information of Customer.

12)

Independent Contractor. Both Parties are independent contractors and nothing in this Agreement creates the relationship of partnership, joint venture, sales agency or principal and agent, and neither party is the agent of the other, and neither party may hold itself out as such to any other party, and neither party has the power or authority in any way to bind the other party contractually. Each Party shall be free to manage and control its business as it sees fit without the management, control or assistance of the other Party, except as otherwise prescribed herein.

13)	Governing Law. This Agreement shall be governed by and construed in accordance with the laws in the State of New York, without regard to its choice of law provisions.

14)

Entire Agreement. This Agreement and attachments contain the entire understanding of the Parties with respect to the matters contained herein and supersedes the Development and Manufacturing Terms and Conditions dated May 30, 2014 (Effective Date) between the Parties. In case one or more amendments, modifications or alterations of this Agreement become necessary, the Parties shall negotiate in good faith on such amendments, modifications or alterations. This Agreement may be amended, modified or altered only by an instrument in writing duly executed by both Parties.

15)

Force Majeure. The Parties hereto shall not be liable in any manner for the failure or delay of fulfillment of all or part of this Agreement, directly or indirectly, owing to governmental orders or restrictions, war, war-like conditions, revolution, riot, looting, strike, lockout, fire, flood or other external causes or circumstances beyond the Parties’ control. Neither WuXi AppTec nor Customer shall be liable for any default, damages (including without limitation any direct, indirect, foreseeable, unforeseeable, consequential or punitive) or delays in shipment for any cause beyond its reasonable control.

16)

Severability. If any one or more of the provisions of this Agreement shall for any reason be held to be illegal or unenforceable, such invalidity or unenforceability shall not affect any other provision of this Agreement or the validity or enforceability of such provision. The unenforceable provision shall be treated as severable and the remaining provisions shall nevertheless continue in full force and effect, giving maximum effect to the intent of the Parties in entering this Agreement.

17)	Survivability. This Agreement shall be binding upon and enure to the benefit of the Parties hereto and their respective legal successors. The following provisions shall survive any termination or expiration of this Agreement: Sections 9, 10, 11(b), 12 through 24.

18)	Arbitration

(a)	In the event of any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, each party shall by written notice to the other have the right to have such dispute referred to the senior management of WuXi AppTec and Customer for attempted resolution by good

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(b)

In the event of the failure to reach a resolution pursuant to Section 18 (a), any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, shall be finally settled by binding arbitration. If WuXi AppTec initiates arbitration, the site of arbitration shall be [*]. If Customer initiates arbitration, the site of arbitration shall be [*]. All disputes shall be settled by three (3) arbitrators. Each Party shall choose one arbitrator from a panel of arbitrators who are residents of the United States, in accordance with the Commercial Arbitration Rules then in effect of the American Arbitration Association (the “AAA Rules”), and the two arbitrators so chosen shall choose a third arbitrator. Any such arbitration shall be conducted in the English language, shall be conducted pursuant to AAA Rules. Any arbitration award shall be final and binding and no appeal shall lie therefrom. Judgment upon the award may be entered in any court of competent jurisdiction. Other than as provided in Section 18(c) below, except for each party's own attorneys' fees and any expenses incurred in producing its own witnesses, all other administrative expenses shall be divided as directed by the arbitrators.

(c)

If either party, notwithstanding the foregoing, should attempt either to resolve any dispute arising in connection with this Agreement in a court of law or equity or to forestall, preempt, or prevent arbitration of any such dispute by resort to the process of a court of law or equity, and such dispute is ultimately determined to be arbitral by such court of law or equity, the arbitrators shall include in their award an amount for the other party equal to all of that other party's costs, including legal fees, incurred in connection with such determination. Nothing in this Section 18 shall prevent a party from seeking a remedy in a court of equity if money damages are not an adequate remedy, (such as enforcement of the confidentiality provisions of this Agreement) or in order to preserve the status quo pending an arbitration award.

19)	Inventions and Technology Transfer.

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20)	Waiver. No waiver of any term, provision or condition of this Agreement (whether by conduct or otherwise) in any one or more instances will be deemed to be or construed as a further or continuing waiver of any such term, provision or condition of this Agreement

21)

Notices. Any notice or report required or permitted to be given or made under this Agreement by one of the Parties hereto the other shall be in writing and shall be deemed to have been sufficiently given for all purposes, and effective as of the date of receipt, if mailed by certified mail return receipt requested, postage prepaid, addressed to such other party at its respective address as follows:

22)	Press Releases. Except as necessary to comply with applicable laws, the text of any press release or other communication to be published by or in the media concerning the subject matter of the Agreement shall require the prior written approval of WuXi AppTec and Customer.

23)

Assignment. Neither party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other which consent shall not be unreasonably withheld or delayed, save that either party shall be entitled without the prior written consent of the other party to assign or transfer this Agreement to its Affiliate or its successor-in-interest to all or substantially all of its assets to which this Agreement relates, whether in connection with a merger, acquisition, sale of asset or other similar transaction. WuXi AppTech may not subcontract or delegate any of its obligations hereunder to a third party without Customer’s express prior written consent.

24)	No Third Party Beneficiaries. The parties to this Agreement do not intend that any terms hereof should be enforceable by any person who is not a party to this Agreement.

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1.	I have reviewed this annual report on Form 10-K of NewLink Genetics Corporation;

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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.	The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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 within those entities, particularly during the period in which this report is being prepared;

b.	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external 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 the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d.	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.	The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

a.	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably 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 internal control over financial reporting.

1.	I have reviewed this annual report on Form 10-K of NewLink Genetics Corporation;

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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.	The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant 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 within those entities, particularly during the period in which this report is being prepared;

b.	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external 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 the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d.	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5.	The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

a.	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably 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 internal control over financial reporting.

1.	The Company’s Annual Report on Form 10-K for the period ended December 31, 2015, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

2.	The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.