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 trials:

▪	IMPRESS (Immunotherapy for Pancreatic Resectable Cancer Survival Study)

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

•	Tergenpumatucel-L is being investigated in a Phase 2b/3 trial in advanced non-small cell lung cancer

•	Dorgenmeltucel-L is being investigated in a Phase 2 trial in advanced melanoma

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•	Complete the Phase 3 clinical trial of algenpantucel-L, our lead HyperAcute pancreas immunotherapy product candidate, and gain regulatory approval.

•	Develop manufacturing, distribution and market access infrastructure to commercialize algenpantucel-L in the United States and establish commercial collaborations in other regions.

•	Expand the target market for algenpantucel-L for the treatment of patients with locally advanced pancreatic cancer.

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

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

•	Further develop our proprietary IDO pathway inhibitor Indoximod (D-1MT).

•	Support the alliances with Genentech and Merck

•	Strengthen our pipeline of immune stimulatory drug candidates, including our infectious disease business.

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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

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•	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 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 immunotherapy technology attacks cancer through several mechanisms. Initially, by introducing allogeneic, whole cancer cells incorporating alpha-Gal to the body, our HyperAcute immunotherapy is designed to teach 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 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 immunotherapy has been added to standard chemotherapy or radiation regimens. Our HyperAcute 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 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 1 year was not reported. However, from the median disease-free survival of 11.4 months, we have inferred that disease-free survival at 1 year is less than 50%.

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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 clinical trial Patients 18-45

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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, few available therapies 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.

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•	NLG2101 phase 2 trial of indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer continues to enroll patients with full enrollment expected in 2015.

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

◦	Phase 1 portion is fully enrolled with results expected to be reported in mid 2015.

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

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

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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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Item 1A.	RISK FACTORS

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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 study 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 study endpoints and completing data analysis for a trial.

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•	severity of the disease under investigation;

•	design of the trial protocol;

•	the size of the patient population;

•	eligibility criteria for the study in question;

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

•	in the case of Ebola vaccine product candidate trials, changes in media coverage of the current Ebola epidemic;

•	availability of competing therapies and clinical trials;

•	efforts to facilitate timely enrollment in clinical trials;

•	patient referral practices of physicians;

•	the 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;

•	deficiencies in the clinical trial operations or trial sites;

•	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;

•	the product candidate may not appear to be more effective than current therapies;

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

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

•	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 the facilities used by, or the manufacturing processes developed by, WuXi, 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 WuXi 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 WuXi may encounter unforeseen difficulties in attempting to manufacture biological materials related to algenpantucel-L at a larger scale than we have previously attempted;

•	WuXi 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 pancreatic cancer, or any subset of such patients, which would not relieve our obligation for certain costs under the WuXi Agreement.

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•	an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

•	requirements to report certain financial arrangements with physicians and others, including reporting any “transfer of value” made or distributed to prescribers and other healthcare providers and reporting any investment interests held by physicians and their immediate family members;

•	a licensure framework for follow-on biologic products, also known as biosimilars;

•	a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

•	creation of the Independent Payment Advisory Board which will have authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs and those recommendations could have the effect of law even if Congress does not act on the recommendations; and

•	establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

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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;

•	the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;

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

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

•	competing technological efforts and market developments;

•	changes in our existing research relationships;

•	our ability to establish collaborative arrangements to the extent necessary;

•	revenues received from any existing or future products; 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;

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•	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 partners 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, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and consumes resources;

•	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.

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•	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 our 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 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;

•	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 successes or failures, 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, on cancer and cancer treatment, on the 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 ratings downgrades by any securities analysts who follow our common stock;

•	other events or factors, including those resulting from 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 act by written consent or to call special meetings;

•	limitation 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

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 FINANCIAL DATA

(1)	From January 1, 2015 through March 4, 2015, we sold 329,402 shares of common stock raising a total of $13.6 million in net proceeds. The data presented above does not include these proceeds.

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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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•	fees paid to contract research organizations in connection with clinical trials;

•	fees paid to investigator sites in connection with clinical trials;

•	fees paid to contract manufacturers in connection with the production of clinical trial materials; and

•	fees paid to vendors in connection with preclinical development activities.

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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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Article 1	DEFINITIONS

1.1	“AAA” shall have the meaning given to such term in Section 10.6.1.

1.2	“Act” means, as applicable, the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq., and/or the Public Health Service Act, 42 U.S.C. §§ 262 et seq., in each case, as such may be amended from time to time.

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1.3

“Affiliate” means, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under common control with such Person. A Person shall be deemed to control another Person if such Person possesses the power to direct or cause the direction of the management, business and policies of such Person, whether through the ownership of more than fifty percent (50%) of the voting securities of such Person, by contract or otherwise.

1.4	“Agreement” shall have the meaning given to such term in the preamble.

1.5	“Agreement Payments” shall have the meaning given to such term in Section 5.6.1.

1.6	“Alliance Manager” shall have the meaning given to such term in Section 2.8.

1.7	“Alternative Product” shall have the meaning given to such term in Section 8.2.2.

1.8

“Applicable Laws” means any and all applicable laws of any jurisdiction which are applicable to any of the Parties or their respective Affiliates in carrying out activities hereunder or to which any of the Parties or their respective Affiliates in carrying out the activities hereunder is subject, and shall include all statutes, enactments, acts of legislature, laws, ordinances, rules, regulations, notifications, guidelines, policies, directions, directives and orders of any statutory authority, tribunal, board, or court or any central or state government or local authority or other governmental entity in such jurisdictions, including the Act and GLPs, GCPs and GMPs.

1.9	“[*]” shall have the meaning given to such term in Section 3.10.3.

1.10	“Biosimilar Application” shall have the meaning given to such term in Section 7.4.5(b).

1.11

“BLA” means a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Authorization Application, filing pursuant to Section 510(k) of the Act, Premarket Approval Application or similar application or submission for Marketing Authorization of a Product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.

1.12

“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; provided, however, that (i) the first Calendar Quarter of this Agreement shall commence on the Effective Date and end at the end of the Calendar Quarter in which the Effective Date occurs and (ii) the last Calendar Quarter of this Agreement shall commence at the commencement of such Calendar Quarter and end on the date of expiration or termination of this Agreement.

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1.13

“Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided, however, that (i) the first Calendar Year of this Agreement shall commence on the Effective Date and end on December 31 of the same year and (ii) the last Calendar Year of this Agreement shall commence on January 1 of the Calendar Year in which this Agreement terminates or expires and end on the date of expiration or termination of this Agreement.

1.14

“Change of Control” means, with respect to Merck, NL or NewLink, as applicable, a transaction with a Third Party(ies) involving, (i) the acquisition, merger or consolidation, directly or indirectly, of Merck, NL or NewLink, as applicable, and, immediately following the consummation of such transaction, the shareholders of Merck, NL or NewLink, as applicable, immediately prior thereto hold, directly or indirectly, as applicable, shares of capital stock of the surviving company representing less than fifty percent (50%) of the outstanding shares of such surviving or continuing company, (ii) the sale of all or substantially all of the assets or business of Merck, NL or NewLink, as applicable, or (iii) a Person, or group of Persons acting in concert, acquire more than fifty percent (50%) of the voting equity securities or management control of Merck, NL or NewLink, as applicable.

1.15	“Clinical Trial” means a Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, and/or post-regulatory approval clinical trial involving human subjects.

1.16	“Code” shall have the meaning given to such term in Section 8.3.3.

1.17	“Combination Product” means a Product which includes one or more Compound(s) in combination with one or more active ingredients other than such Compound(s), [*]; provided, however, nothing contained in this Agreement shall be interpreted as a grant of a license by NewLink to Merck to any other proprietary active compounds of NewLink (other than Compounds).

1.18	“Commercialize” means to promote, market, distribute, sell and provide product support for a Product, and “Commercializing” and “Commercialization” shall have correlative meanings.

1.19	“Commercially Reasonable Efforts” means with respect to the efforts to be expended by a Party with respect to any objective, the [*]. It is understood and agreed that with respect to the Development, Manufacture and Commercialization of Product by either Party, such efforts [*] and [*] taking into account [*] and other [*]. Commercially Reasonable Efforts shall be [*], and it is [*], and [*].

1.20	“Competitor” shall have the meaning given to such term in Section 10.2.3.

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1.21	“Compound” means (i) the Current Compound and (ii) [*], including [*], in each case, [*], and in each case of this clause (ii) [*].

1.22

“Confidential Information” means any and all proprietary Know-How, information and data, including scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method, which is provided by or on behalf of one Party to the other Party and/or its Affiliate in connection with this Agreement.

1.23

“Control”, “Controls” or “Controlled by” means, with respect to any Patent Rights, Know-How or other intellectual property assets or rights, as applicable, the possession of (whether by ownership or license or other right, other than pursuant to this Agreement) or the ability of a Party to grant access to, or a license or sublicense of, such items or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to grant the other Party such access or license or sublicense.

1.24	“Covered by” or “Cover” or the like, means, with respect to a given Product in a given country, that [*] is claimed by a Valid Claim in such country and such Valid Claim would be infringed by the sale of such Product in such country but for the licenses granted to Merck hereunder; provided, that [*] for which [*] has been [*], and [*] is actually [*].

1.25	“Critical Issue” shall have the meaning given to such term in Section 2.7.2.

1.26	“Current Compound” means the [*] vaccine candidate known as rVSV-EBOV and more particularly described on Schedule 1.26.

1.27	“Current Product” means the [*] or [*] containing the Current Compound [*] or any [*], as the [*], for the treatment of Ebola [*] other than [*], but excluding, for clarity, [*].

1.28	“Current Product Commercially Reasonable Efforts Obligation” shall have the meaning given to such term in Section 3.5.1.

1.29	“[*]” shall have the meaning given to such term in [*].

1.30

“Develop” means to research, develop, analyze, test and conduct preclinical, clinical and all other regulatory trials for Compound or a Product, as well as any and all activities pertaining to manufacturing development, formulation development, manufacturing scale-up and lifecycle management, including new indications, new formulations and all other activities related to securing and maintaining Marketing Authorization for a Product,

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1.31	“Dollar” or “$” means United States dollars.

1.32	“Effective Date” shall have the meaning given to such term in the preamble.

1.33

“EU” or “European Union” means (a) the European Union and its member states as of the Execution Date, which are: Austria, Belgium, Bulgaria, Croatia, Cyprus , Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom, and (b) each of their successors to the extent such successors occupy the same territory and are included as part of the European Union.

1.34	“Excluded Claim” shall have the meaning given to such term in Section 10.6.6.

1.35	“Existing Confidentiality Agreement” means that certain Confidential Disclosure Agreement, dated [*], between Merck and NewLink.

1.36	“Existing IND” shall have the meaning given to such term in Section 2.9.2.

1.37	“FDA” means the United States Food and Drug Administration or any successor governmental authority having substantially the same function.

1.38	“Field” means any and all uses or purposes, including the treatment, palliation, diagnosis or prevention of any human or animal disease, disorder or condition.

1.39

“First Commercial Sale” means, with respect to a Product in a given country in the Territory, the first shipment to a Third Party of commercial quantities of such Product sold in such country to such Third Party on arm’s length terms by Merck, its Affiliate or sublicensee for end use or consumption of such Product in the Field in such country (following, in all cases, the receipt of Marketing Authorization for such Product in such country). For clarity, First Commercial Sale shall be determined on a Product-by-Product basis.

1.40	“GAVI Alliance” means the Global Alliance for Vaccines and Immunization (GAVI), an independent non-profit organization established under the laws of Switzerland, with the purpose of providing support for improvements of vaccinations and immunization in the poorest countries of the world.

1.41	“GAVI Eligible Countries” means [*], as such [*]; provided that in no event [*]. For the avoidance of doubt, [*] shall, following [*].

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1.42	“Good Clinical Practices” or “GCPs” means then-current Good Clinical Practices as such term is defined from time to time by the FDA and governmental authorities in the European Union, pursuant to its regulations, guidelines or otherwise.

1.43	“Good Laboratory Practice” or “GLPs” means then-current standards for laboratory activities for pharmaceuticals or biologicals, as applicable, as defined from time to time by the FDA and governmental authorities in the European Union, pursuant to its regulations, guidelines or otherwise.

1.44	“Good Manufacturing Practices” or “GMPs” means then current Good Manufacturing Practices as such term is defined from time to time by the FDA and governmental authorities in the European Union, pursuant to its regulations, guidelines or otherwise.

1.45	“Human Materials” shall have the meaning given to such term in Section 2.3.2.

1.46	“IND” means an Investigational New Drug application, Clinical Study Application, Clinical Trial Exemption or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

1.47	“Indemnified Party” shall have the meaning given to such term in Section 9.1.3.

1.48	“Indemnifying Party” shall have the meaning given to such term in Section 9.1.3.

1.49	“Initiation” means, with respect to a Clinical Trial, the administration of the first dose of the Current Product (or an Alternative Product, as applicable) to a properly enrolled patient in such Clinical Trial.

1.50	“Insolvency Event” shall have the meaning given to such term in Section 8.3.1(b).

1.51	“Inventory” shall have the meaning given to such term in Section 2.9.3(a).

1.52	“Joint Program Know-How” shall have the meaning given to such term in Section 7.2.1(c).

1.53	“Joint Program Patent Rights” shall have the meaning given to such term in Section 7.2.1(c).

1.54	“Joint Steering Committee” or “JSC” means the joint steering committee established to oversee the activities hereunder as more fully described in Section 2.6.

1.55	“Know-How” means any and all proprietary information and materials, including discoveries, improvements, processes, methods, protocols, formulas, molecular constructs,

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1.56	“Liabilities” shall have the meaning given to such term in Section 9.1.1.

1.57

“Manufacture” or “Manufacturing” means, with respect to a compound or product, including a Compound, Product and any other active pharmaceutical ingredient in a Product, the receipt, handling and storage of active pharmaceutical ingredients and other materials, the manufacturing, processing, packaging and labeling (excluding the development of packaging and labeling components for Marketing Authorization), holding (including storage), quality assurance and quality control testing (including release and stability) of such compound or product (other than quality assurance and quality control related to development of the manufacturing process, which activities shall be considered Development activities) and shipping of such compound or product.

1.58	“Manufacturing Consultation” shall have the meaning given to such term in Section 2.9.3(b).

1.59	“Marketing Authorization” means all approvals (including BLA approval, as applicable) from the relevant Regulatory Authority necessary to market and sell a Product in any country (including all applicable Price Approvals even if not legally required to sell Product in a country).

1.60	“Merck” shall have the meaning given to such term in the preamble.

1.61	“Merck Background Know-How” means all Know-How which (i) is in the Control of Merck or its Affiliates as of the Effective Date or during the Term, (ii) is not in the public domain, and (iii) [*]; provided, however, that Merck Background Know-How shall not include any Program Know-How.

1.62	“Merck Background Patent Rights” means Patent Rights that (i) are in the Control of Merck or its Affiliates as of the Effective Date or during the Term, and (ii) claim, cover or disclose Merck Background Know-How; provided, however that Merck Background Patent Rights shall not include any Program Patent Rights.

1.63	“Merck Indemnitees” shall have the meaning given to such term in Section 9.1.2.

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1.64	“Merck Know-How” means (i) all Merck Background Know-How and (ii) all Merck Program Know-How Controlled by Merck or any of its Affiliates.

1.65	“Merck Patent Rights” means (i) all Merck Background Patent Rights and (ii) all Merck Program Patent Rights Controlled by Merck or any of its Affiliates.

1.66	“Merck Program Know-How” shall have the meaning given to such term in Section 7.2.1(b).

1.67	“Merck Program Patent Rights” shall have the meaning given to such term in Section 7.2.1(b).

1.68	“Milestone Event” shall have the meaning given to such term in Section 5.2.

1.69	“Milestone Payment” shall have the meaning given to such term in Section 5.2.

1.70	“NewLink” shall have the meaning given to such term in the preamble.

1.71

“NewLink Canada License” means, collectively, (i) that certain Sole License Agreement for Recombinant Vesicular Stomatitis Virus Vaccines For Viral Hemorrhagic Fevers, between Her Majesty the Queen in Right of Canada (as represented by the Minister of Health, acting through the Public Health Agency of Canada (“Public Health Canada”)) and NewLink, dated as of [*], and (ii) [*] between Public Health Canada and NewLink dated as of [*], in each case, as the foregoing may be further amended in accordance with Section 3.1.3.

1.72	“NewLink Existing Funding Agreements” means the agreements set forth on Schedule 1.72.

1.73	“NewLink Existing Manufacturing Agreements” means the agreements set forth on Schedule 1.73.

1.74	“NewLink Existing Third Party Agreements” means (i) the NewLink Canada License, (ii) the NewLink Existing Manufacturing Agreements, and (iii) the NewLink Existing Funding Agreements.

1.75	“NewLink Funding Agreements” shall have the meaning given to such term in Section 3.10.1.

1.76	“NewLink Future Funding Agreements” shall have the meaning given to such term in Section 3.10.1.

1.77	“NewLink Indemnitees” shall have the meaning given to such term in Section 9.1.1.

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1.78

“NewLink Know-How” means all Know-How which (i) is in the Control of NewLink or its Affiliates as of the Effective Date or during the Term (subject to Section 10.2), (ii) is not in the public domain, and (iii) [*] is otherwise [*]. For the avoidance of doubt, NewLink Know-How shall include (x) any and all Know-How licensed under the NewLink Canada License, (y) all NewLink Program Know-How and (z) NewLink’s interest in any Joint Program Know-How.

1.79

“NewLink Patent Rights” means Patent Rights that (i) are in the Control of NewLink or its Affiliates as of the Effective Date or during the Term (subject to Section 10.2), and (ii) (a) claim, cover or disclose [*], and/or (b) claim, cover or disclose any NewLink Know-How. The NewLink Patent Rights shall include the Patent Rights identified in Schedule 1.79 as well as any Patent Rights licensed under the NewLink Canada License. Schedule 1.79 may be updated by the Parties from time to time as provided in Section 3.2. NewLink Patent Rights shall include (x) NewLink Program Patent Rights and (y) NewLink’s interest in any Joint Program Patent Rights.

1.80	“NewLink Program Know-How” shall have the meaning given to such term in Section 7.2.1(a).

1.81	“NewLink Program Patent Rights” shall have the meaning given to such term in Section 7.2.1(a).

1.82	“NewLink Third Party Agreements” means (i) the NewLink Existing Third Party Agreements, (ii) any other agreements [*] relating to the Development, Manufacture, Commercialization or other exploitation of Compounds or Products, including any agreements [*] or the [*], and (iii) any NewLink Funding Agreement [*] and any agreement included on Schedule 3.10.

1.83	“NIH-Liberia Clinical Trial” means the Clinical Trial which is [*], and which [*].

1.84	“Officials” shall have the meaning given to such term in Section 2.5.2.

1.85	“Other Product Commercially Reasonable Efforts Obligation” shall have the meaning given to such term in Section 3.5.1.

1.86	“[*]” shall have the meaning given to such term in [*].

1.87	“Party” means Merck or NewLink, individually, and “Parties” means Merck and NewLink, collectively.

1.88	“Payment” shall have the meaning given to such term in Section 2.5.2.

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1.89

“Patent Rights” means any and all patents and patent applications in the Territory (which for the purpose of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention), including divisionals, continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates, and the like of any such patents and patent applications, and foreign equivalents of the foregoing.

1.90	“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.

1.91	“Phase I Clinical Trial” means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).

1.92	“Phase II Clinical Trial” means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b).

1.93	“Phase III Clinical Trial” means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c).

1.94	“Pivotal Clinical Trial” means the first to occur of (i) [*] or (ii) [*] which is [*] of the [*] for clarity, any [*].

1.95	“Price Approvals” means in countries in the Territory where Regulatory Authorities may approve or determine pricing or pricing reimbursement for pharmaceutical products, such approval or determination.

1.96	“Product” means any pharmaceutical composition or preparation (in any and all dosage forms) in final form containing a Compound, [*]. For clarity, except with respect to [*], different [*] for the purposes of this Agreement.

1.97	“Product Diligence Obligations” shall have the meaning given to such term in Section 3.5.1.

1.98	“Product Materials” shall have the meaning given to such term in Section 6.2.21.

1.99	“Product Net Sales” means the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of Product in the Royalty Bearing Territory for use in the Field sold by Merck or its Related Parties to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:

(a)	[*];

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(b)	[(];

(c)	[*] that are [*];

(d)	[*]; or any other [*]; provided, that for clarity, nothing in this clause (d) shall be deemed to exclude [*] to the [*];

(e)	[*];

(f)	[*], including [*]; provided that any such [*];

(g)	[*] of the [*] and [*]; and

(h)	[*].

1.100

“Program Know-How” means any Know-How (including any Compounds) that is first conceived, discovered, made and/or reduced to practice (as would be necessary to establish inventorship under United States patent law (regardless of where the applicable activities occurred)) by or on behalf of either Party or its Affiliate (or their respective employees, agents or consultants) or jointly by both Parties or their respective Affiliates (or their respective employees, agents or consultants) in performing the Transition Program or other activities under this Agreement.

1.101	“Program Patent Rights” means any and all Patent Rights that claim, cover or disclose Program Know-How.

1.102	“Project Leader” shall have the meaning given to such term in Section 2.8.

1.103

“Prosecute” means, in relation to any Patent Rights, (i) to prepare and file patent applications, including re-examinations or re-issues thereof, and represent applicant(s) or assignee(s) before relevant patent offices or other relevant authorities during examination, re-examination and re-issue thereof, in appeal processes and interferences, oppositions or any equivalent proceedings, (ii) to secure the grant of any Patent Rights arising from such patent application, (iii) to maintain in force any issued Patent Right (including through

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1.104	“Providers” shall have the meaning given to such term in Section 2.3.2.

1.105	“Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the manufacturing, marketing, reimbursement and/or pricing of a pharmaceutical product in the Territory, including, in the United States, the FDA.

1.106	“Regulatory Documentation” shall have the meaning given to such term in Section 2.9.2.

1.107	“Related Party” means each of Merck, its Affiliates, and their respective sublicensees (which term does not include distributors), as applicable.

1.108	“Royalty Bearing Territory” means the Territory excluding [*] and [*].

1.109	“Royalty Term” shall have the meaning given to such term in Section 5.4.2.

1.110	“rVSV” means the replication-competent recombinant vesicular stomatitis virus vector system.

1.111	“Safety Termination” shall have the meaning given to such term in Section 8.2.1.

1.112	“Sensitive Information” shall have the meaning given to such term in Section 10.2.3.

1.113	“Term” shall have the meaning given to such term in Section 8.1.

1.114	“Terminated Products” shall have the meaning given to such term in Section 8.3.2(a).

1.115	“Territory” means worldwide, including all of the countries in the world, and their territories and possessions.

1.116	“Third Party” means a Person other than Merck and its Affiliates, NL and its Affiliates and NewLink and its Affiliates.

1.117	“Third Party Claim” shall have the meaning given to such term in Section 9.1.1.

1.118	“Third Party Funding Sources” means Third Party funding sources, including [*] and [*] with respect to the Development, Manufacture and/or Commercialization of Compound and/or Product.

1.119	“Transfer Taxes” shall have the meaning given to such term in Section 5.6.1.

1.120	“Transition Period” shall mean the period commencing on the Effective Date and ending upon the later to occur of (i) completion of all activities under the Transition Plan, or (ii)

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1.121	“Transition Plan” means the plan for transitioning [*] activities with respect to [*] from NewLink to Merck, as such plan is established by the JSC in accordance with this Agreement, and as such plan may be updated from time to time in accordance with this Agreement.

1.122	“Transition Plan Outline” means the outline for the plan for transitioning [*] activities with respect to Compound and Product as set forth on Schedule 1.122.

1.123	“Transition Program” means the conduct of certain ongoing [*] activities by or on behalf of NewLink with respect to [*], and the transition of such activities to Merck, as set forth in Article 2 and in the Transition Plan.

1.124	“Tri-Party Confidentiality Agreement” means that certain Confidentiality and Non-Disclosure Agreement, dated [*], between Public Health Canada, Merck, NewLink and NL.

1.125

“Valid Claim” means a claim of an issued and unexpired patent (as may be extended through supplementary protection certificate or patent term extension) within the NewLink Patent Rights, which claim has not been abandoned or revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period), and has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.

1.126

“Violation” means that a Party or any of its officers or directors or any other NewLink personnel (or other permitted agents of a Party performing activities hereunder) has been: (1) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/exclusions/authorities.asp); (2) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (http://exclusions.oig.hhs.gov/) or listed as having an active exclusion in the System for Award Management (http://www.sam.gov); or (3) listed by any US Federal agency as being suspended, proposed for debarment, debarred, excluded or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (http://www.fda.gov/ora/compliance_ref/debar/) (each of (1), (2) and (3) collectively the “Exclusions Lists”).

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ARTICLE 2	TRANSITION PROGRAM

2.1	General. Each Party, at such Party’s cost, shall engage in the Transition Program upon the terms and conditions set forth in this Agreement, including performing all activities to be performed by such Party as set forth in the Transition Plan.

2.2

Transition Plan; Conduct of Transition Program. Within [*] after the Effective Date, the Parties shall establish the initial Transition Plan which shall be based on the Transition Plan Outline. Each Party shall, [*] perform its activities under the Transition Program, including by using its good faith, diligent efforts to allocate sufficient time, effort, equipment and facilities to the Transition Program and to use personnel with sufficient skills and experience as are required to accomplish the Transition Program in accordance with the terms of this Agreement and the Transition Plan, as applicable. Merck shall be prepared to receive, and NewLink shall promptly deliver to Merck, [*] pursuant to and as set forth in the Transition Plan or [*]. In performing activities under the Transition Program, NewLink shall consult with Merck and shall [*] with respect to the activities conducted under the Transition Program, including [*], subject to Section 3.10.2 with respect to the activities under NewLink Funding Agreements and subject to Section 2.7.2 with respect to amendments of the Transition Plan.

2.3	Compliance; Additional Requirements.

2.3.1

General. Each Party shall conduct its activities hereunder, including activities under the Transition Program and activities under the NewLink Funding Agreements, in compliance with all Applicable Laws. Each Party shall notify the other in writing of any deviations from Applicable Laws. In addition, each Party hereby certifies that it has not employed or otherwise used in any capacity and will not employ or otherwise use in any capacity, the services of any Person suspended, proposed for debarment, or debarred under United States law, including 21 USC 335a, or any foreign equivalent thereof, in performing any portion of the Transition Program or other activities under this Agreement (including activities under the NewLink Funding Agreements). Each Party shall notify the other in writing immediately if any such suspension, proposed debarment or debarment occurs or comes to its attention, and shall, with respect to any Person so suspended, proposed for debarment or debarred, promptly remove such Person from performing any Transition Program activities, function or capacity related to the Transition Program or any other activities under this Agreement (including activities under the NewLink Funding Agreements).

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2.3.2

Use of Human Materials. Without limiting the provisions of Section 2.3.1, if any human cell lines, serum samples, biological samples, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) have been or are to be collected and/or used in the Transition Program (or under the NewLink Funding Agreements), NewLink represents and warrants (i) that it has complied, and shall comply, with all Applicable Laws relating to the collection and/or use of the Human Materials and (ii) that it has obtained, and shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. NewLink shall provide documentation of such approvals and consents upon Merck’s request. NewLink further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.

2.3.3

Use of Third Party Intellectual Property. In performing activities under the Transition Program (or activities under the NewLink Funding Agreements), [*] shall not (i) incorporate any Know-How or other intellectual property owned by any Third Party into any Compound, Product or other Program Know-How or (ii) otherwise use any Know-How or other intellectual property owned by any Third Party in the performance of the Transition Program (or activities under the NewLink Funding Agreements). Notwithstanding the foregoing, [*] shall be allowed to [*] under the [*] to perform the Transition Program.

2.3.4

Clinical Trial-related Adverse Events. With respect to Clinical Trials being carried out by or on behalf of a Party for the Current Product during the Transition Period, serious adverse experience reports as defined in 21 CFR 312.32 must be forwarded to the other Party within [*] after receipt of the information. In addition, each Party shall furnish to the other Party copies of the end of study summary of adverse experiences in English as promptly as possible following completion of such Clinical Trial (or earlier, as reasonably requested by such other Party). Within [*] after the Effective Date, NewLink and Merck (or its Affiliate) shall enter into a pharmacovigilance agreement in order to share safety information and satisfy related requirements of Regulatory Authorities and Applicable Law with respect to Compounds and Products.

2.4	Use of Third Parties. Each Party shall be entitled to utilize the services of Third Parties to perform its activities hereunder; provided that [*] that are identified in [*] or [*] expand

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2.5	Compliance with Ethical Business Practices.

2.5.1

Compliance with Corporate Policy. NewLink acknowledges that Merck’s corporate policies require that business must be conducted within the letter and spirit of the law. By signing this Agreement, each Party agrees to conduct the activities contemplated herein (including activities contemplated under the NewLink Funding Agreements) in a manner which is consistent with both law and good business ethics.

2.5.2

Governments and International Public Organizations. Without limitation of the foregoing, each Party warrants that none of its employees, agents, officers or other members of its management are officials, officers, agents, representatives of any government or international public organization. Each Party agrees that it shall not make any payment, either directly or indirectly, of money or other assets, including

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2.5.3	No Authority. Each Party acknowledges that no employee of the other Party or its Affiliates shall have authority to give any direction, either written or oral, relating to the making of any commitment by such Party or its agents to any Third Party in violation of terms of this or any other provisions of this Agreement.

2.5.4

Exclusions Lists. Each Party certifies to the other that as of the Effective Date it has screened itself, and its officers and directors, against the Exclusions Lists and that it has informed such other Party whether it, or any of its officers or directors has been in Violation. After the execution of this Agreement, each Party shall notify the other in writing immediately if any Violation occurs or comes to its attention, and shall, with respect to any person or entity in Violation, promptly remove such person or entity from performing any Transition Program activities, function or capacity related to the Transition Program or otherwise related to activities under this Agreement (including activities under the NewLink Funding Agreements).

2.6	Joint Steering Committee. The Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to generally oversee the Transition Program, and to oversee [*].

2.6.1

Composition of the JSC. As soon as practicable, but in no event more than [*] after the Effective Date, the Parties will establish the JSC, which will be comprised of an equal number of representatives of each Party, with three (3) representatives of NewLink (who shall be employees of NewLink) and three (3) representatives of Merck (who shall be employees of Merck or its Affiliate); provided, however, that the Parties may agree to increase or decrease the number of equal representatives from each Party. These representatives shall have appropriate technical credentials, experience and knowledge, and ongoing familiarity with the Parties’ activities and interactions hereunder. Each Party may replace its representative(s) at any time upon prior notice to the other Party. The JSC will meet in person or by teleconference at

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2.6.2	Responsibilities. The JSC shall:

(a)	Review, oversee and direct the efforts, progress and status of the Transition Program (including technology transfer, if any), including reviewing and directing the conduct of the Transition Program;

(b)	Review, oversee and direct the efforts, progress and status of [*];

(c)	Review and approve amendments to the Transition Plan from time to time;

(d)	Review [*] issues that arise in connection with [*], during the [*];

(e)	Oversee and make decisions with respect to matters related to [*] in connection with Compound and Product; and

(f)	Address such other matters relating to the activities under this Agreement designated to be addressed by the JSC under this Agreement or as either Party may otherwise bring before the JSC.

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2.6.3

Subcommittees. The JSC shall have the right to form subcommittees as determined by the JSC in order to address any particular matters within the authority of the JSC. For clarity, any such subcommittee shall have no broader rights and no broader authority than the JSC, and shall only exercise those rights and authorities as designated to such subcommittee by the JSC. Any such subcommittee shall have no decision making authority, but shall make recommendations to the JSC for the JSC’s review and approval.

2.6.4

Disbandment of JSC. The JSC shall be automatically disbanded (without any further actions by either Party) and shall have no further authority with respect to the activities hereunder, upon the end of the Transition Period. Thereafter, the JSC shall have no further obligations under this Agreement and the Project Leaders shall be the contact persons for the exchange of information under this Agreement.

2.6.5

Development Forums. During the [*] period following the disbanding of the JSC in accordance with Section 2.6.4, the Parties shall meet in person or by teleconference no less than [*] to discuss Merck’s Development of Products, including Products other than the Current Product (the “Development Forum”). At each such meeting, Merck will provide NewLink with an update on the status of the Development of the Products, and Merck’s ongoing plan for the Development of Products (provided that, for clarity, such plan shall be non-binding and for informational purposes only). In addition, during such period, Merck will promptly notify NewLink if Merck suspends or otherwise terminates the Development or Commercialization of any Compound or Product.

2.7	Scope of Committee Oversight and Decision-Making Authority.

2.7.1

Scope of Committee Oversight. The JSC shall not have the right to: (i) modify or amend the terms and conditions of this Agreement; (ii) waive either Party’s compliance with the terms and conditions of this Agreement; (iii) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement or (iv) following agreement with respect to the initial Transition Plan, amend the Transition Plan in a manner that would [*], unless such amendment is mutually agreed to by the Parties in writing; provided that, for the avoidance of doubt, if the work proposed in the amendment to the Transition Plan [*] or otherwise [*], then [*] such work and the [*].

2.7.2	Decision-Making Authority. The goal of all decision-making of the JSC shall be to achieve consensus. All decisions of the JSC with respect to matters over which it has decision-making authority shall be made by unanimous vote of the applicable

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2.8

Project Leads and Alliance Managers. Merck and NewLink each shall appoint an employee of such Party (or its Affiliate, as applicable) as its project leader (the “Project Leader”) who shall be the primary contact between the Parties with respect to the Transition Program and who shall coordinate each Party’s role in the Transition Program. Each Party shall notify the other within [*] of the Effective Date of the appointment of its Project Leader and shall notify the other Party as soon as practicable upon changing this appointment. In addition, each Party may also appoint, at its discretion, an alliance manager to facilitate communications between the Parties hereunder (the “Alliance Manager”). If a Party appoints an Alliance Manager, such Party shall notify the other of the appointment of its Alliance Manager and shall notify the other Party as soon as practicable upon changing this appointment.

2.9	Exchange of Information and Materials.

2.9.1

General. As soon as reasonably practicable following Effective Date (but in all cases within [*] after the Effective Date or such other period of time as agreed to by the Parties), NewLink shall disclose to Merck in English (in writing and in an electronic format) all NewLink Know-How. Thereafter on an ongoing basis during the Term upon the reasonable request of Merck, NewLink shall cooperate with Merck and promptly disclose to Merck in English (and deliver in writing and in an electronic format) (i) any other NewLink Know-How (including any Program Know-How) relating to Compound or Product (or the Development, Manufacture, use or Commercialization thereof) as may be developed or identified by or on behalf of NewLink (or its Affiliates), and (ii) from the Effective Date until [*], any other materials and documentation (including [*]) in NewLink’s (or its Affiliate’s or subcontractor’s) possession or Control as may be reasonably requested by Merck from time to time that relate to Compounds or Products and are to be used by or on behalf of Merck in the performance of its activities under this Agreement, including [*]. Without limiting the generality of the foregoing, [*], NewLink shall [*] to provide [*] pursuant to, and in accordance with, [*].

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2.9.2

Technology Transfer; Transition of Activities. As soon as reasonably practicable following the Effective Date (but in all cases within [*] or such other period of time as agreed to by the Parties), NewLink shall (i) transfer to Merck (or its designee) all materials (other than Inventory) related to Compound or Product in NewLink’s (or any of its Affiliate’s or contractor’s) possession or Control, including [*], and (ii) transfer and assign to Merck (or its designee), and NewLink hereby does transfer and assign to Merck, all Regulatory Documentation (other than the Existing IND) related to Compound or Product (including the transfer to Merck of a database that contains all relevant information regarding adverse events that have been observed during any clinical trials or studies with respect to Compound or Product prior to the Effective Date). In addition, upon Merck’s request, NewLink shall transfer and assign to Merck (or its designee) [*] (the “Existing IND”). NewLink shall assist Merck, and each Party shall reasonably cooperate, to ensure [*], including providing [*] in connection therewith. As used herein, the term “Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals (including all Marketing Authorizations), all correspondence submitted to or received from Regulatory Authorities (including [*]) and all supporting documents in connection therewith, and all reports and documentation in connection with clinical studies and tests (including [*]), and [*] in any of the foregoing, including all INDs, BLAs, [*], in each case related to a Compound and/or Product.

2.9.3	Inventory Transfer and Manufacturing Technology Transfer.

(a)

Inventory Transfer. At the request of Merck from time to time as set forth in the Transition Plan, NewLink shall promptly transfer title to Merck and deliver to Merck (or its designee) (at a location to be [*]), [*] any or all (as and to the extent [*]) inventory of Compound and Product (including [*]) held by or on behalf of NewLink or any of its Affiliates (including any such inventory [*]) (the “Inventory”).

(b)

Manufacturing Technology Transfer. Without limiting the provisions of Sections 2.9.1 and 2.9.2, as soon as reasonably practicable following the Effective Date (but in all cases within [*] after the Effective Date or such other period of time as agreed to by the Parties), NewLink shall transfer or cause to be transferred (including from its Third Party contract manufacturers) to Merck or its Affiliate (or a Third Party manufacturer designated by Merck), copies in English (in writing and in an electronic format) of all [*] that is related to the manufacture of the Compounds and/or Products, in order to enable Merck (or its designee) to manufacture the Compounds and Products, including [*] to manufacture Compounds and Products, including [*]. In addition, at the request of Merck from time to time, NewLink shall make its (and its Affiliates’) employees and consultants (including personnel of its

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2.9.4

Assignment of Certain Existing Agreements. At the written request of Merck, NewLink shall, to the extent legally permissible (and, to the extent consent is required from the relevant counterparty, [*]), (i) assign to Merck (or its Affiliate) any or all (as designated by Merck) of [*] and/or (ii) assist Merck (or its Affiliate) in [*] to cover the subject matter of such [*], as applicable, in each case of (i) and/or (ii), [*]; provided that NewLink shall not be obligated to assign any such [*] if such [*] is [*]. In the event that any [*] is assigned to Merck, NewLink shall [*], or related to, any such [*] as a result of, or in connection with, [*] of such [*], but which [*]. In the event that a given [*] is assigned to Merck in accordance with this Section 2.9.4, then such [*] shall [*].

2.9.5

Transition and Transition Plan; Ongoing Assistance. Without limiting the foregoing provisions of this Section 2.9, NewLink shall perform the activities to be performed by NewLink as set forth in the Transition Plan (including technology transfer). NewLink shall, during the period from the Effective Date [*], perform such other reasonable activities and provide such other reasonable assistance as Merck may reasonably request from time to time, in order to transition the Development, Manufacturing and Commercialization of Compound and Product to Merck and [*] Develop, Manufacture and Commercialize Compound and Product, including [*]; provided, that if Merck requests any such assistance after the end of the Transition Period, the Parties will agree on the scope and plan for such activities (including a plan for addressing the costs and expenses of such activities) prior to NewLink’s performance thereof, [*].

2.9.6	Data From Third Party Studies. To the extent that any Development activities (including clinical trials) are being conducted by, or sponsored by, a Third Party (including [*]) with respect to Compound or Product, [*] to obtain [*], and to [*], including the [*].

2.9.7	[*]. The Parties agree and acknowledge that, except as expressly set forth in Section 2.9.5, the activities set forth in this Section 2.9, and any other activities [*], shall be [*].

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2.10	Records and Reports.

2.10.1	Records. Each Party shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved in the performance of the Transition Program or other activities under this Agreement (including activities under the NewLink Funding Agreements).

2.10.2

Copies and Inspection of Records; Reports. Merck shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all such records of NewLink referred to in Section 2.10.1. Merck shall maintain such records and the information disclosed therein in confidence in accordance with Section 4.1. Merck shall have the right to arrange for its employee(s) and/or consultant(s) involved in the activities contemplated hereunder to visit the offices and laboratories of NewLink and any of its Third Party contractors as permitted under Section 2.4 during normal business hours and upon reasonable notice, and to discuss work performed for the Transition Program [*] with the technical personnel and consultant(s) of NewLink. Upon the reasonable request of Merck, NewLink shall provide copies of such NewLink records described in Section 2.10.1.

2.10.3

[*] Reports. Within [*] following the end of each [*], NewLink shall provide to Merck a written progress report in English which shall summarize the work performed to date on the Transition Program [*] in relation to the [*] of the [*] and provide [*] by the [*] relating to the progress of the goals or performance of the Transition Program [*] under the [*]. NewLink shall use Commercially Reasonable Efforts to [*]. For clarity, all such reports shall be considered the Confidential Information [*].

2.10.4

Data Integrity. Each Party acknowledges the importance of ensuring that the Transition Program (and the activities under the NewLink Funding Agreements) is undertaken in accordance with the following good data management practices: (i) data is being generated using sound scientific techniques and processes; (ii) data is being accurately and reasonably contemporaneously recorded in accordance with good scientific practices by Persons conducting research hereunder; (iii) data is being analyzed appropriately without bias in accordance with good scientific practices; and (iv) all data and results are being stored securely and can be easily retrieved. Each Party agrees that it shall carry out the Transition Program (and activities under the NewLink Funding Agreements) so as to collect and record any data generated therefrom in a manner consistent with the foregoing requirements.

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2.11	Transition Program Costs. [*] costs in connection with performing Transition Program activities.

ARTICLE 3	LICENSE, DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION

3.1	License Grants by NewLink.

3.1.1

NewLink Patent Rights and NewLink Know-How. Subject to the terms and conditions of Section 3.1.3, NewLink hereby grants to Merck an exclusive (even as to NewLink and its Affiliates), royalty-bearing license in the Territory under the NewLink Patent Rights and NewLink Know-How, with a right to grant and authorize sublicenses (subject to the restriction set forth below) through multiple tiers, to research, develop, make, have made, use, offer to sell, sell, import, export and/or otherwise exploit Compounds and Products in the Field. Merck may grant sublicenses of the rights granted to it under this Section 3.1.1 [*]; provided, however, that (a) promptly following the execution of any such sublicense for Commercialization rights with a Third Party, Merck shall [*], and (b) Merck shall be responsible for ensuring that the performance by any of its sublicensees hereunder that are exercising rights under a sublicense hereunder is in accordance with the applicable terms of this Agreement, and the grant of any such sublicense shall not relieve Merck of its obligations under this Agreement (except to the extent they are performed by any such sublicensee(s) in accordance with this Agreement).

3.1.2

NewLink Retained Rights. Notwithstanding the scope of the exclusive license granted to Merck under Section 3.1.1, subject to the terms and conditions of this Agreement, NewLink shall retain rights under the NewLink Patent Rights and the NewLink Know-How for the sole purpose of performing NewLink’s obligations under the Transition Program in accordance with this Agreement and the Transition Plan and to perform activities expressly set forth in the NewLink Funding Agreements in accordance with this Agreement (including Section 3.10). NewLink shall [*].

3.1.3

NewLink Canada License. Notwithstanding anything to the contrary herein, all licenses or other grants granted by NewLink to Merck hereunder with respect to any NewLink Know-How or NewLink Patent Rights that are owned by Public Health Canada and licensed to NewLink under the NewLink Canada License shall at all times be subject to the terms and conditions of the NewLink Canada License. It is the intent of the Parties that [*], and as such, each Party hereby covenants that it shall [*] and shall [*] to include in [*] (provided that, [*] may also [*] that are not

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3.2

Non-Exclusive License Grant to Merck. In the event that the research, development, making, having made, use, offer for sale, sale, import and/or other exploitation by Merck, or Merck’s Related Parties, of Compound(s) or Product(s) would infringe a claim of an issued letters patent which NewLink (or its Affiliate) Controls and which patents are not covered by the grant in Section 3.1 (an “Additional NewLink Patent”), Merck or NewLink, as applicable, shall so notify the other Party thereof. Thereafter, (i) the Parties will [*] and (ii) such Additional NewLink Patent [*]. Notwithstanding the foregoing, if Merck notifies NewLink in writing that [*] shall [*] included in the [*] and shall [*]. Notwithstanding the foregoing, if the exercise by Merck of the license under Section 3.1 with respect to any Additional NewLink Patent would [*], such patent shall [*] for such [*] were notified by [*] at the time the Additional NewLink Patent [*]; provided, however, that [*] to [*] the [*].

3.3

Non-Exclusive License Grants to NewLink. If NewLink’s performance of activities under the Transition Program requires a license under any Merck Patent Rights or under any Merck Know-How, as applicable, Merck shall grant and hereby grants to NewLink, a non-exclusive, non-transferable, non-sublicensable, royalty-free license under such Merck Patent Rights and/or Merck Know-How, as applicable, solely to perform such activities under the Transition Program in accordance with this Agreement. For clarity, the foregoing licenses set forth in this Section 3.3 shall not limit in any way the exclusive licenses granted to Merck under Section 3.1.

3.4

No Grant of Inconsistent Rights by NewLink. NewLink (and its Affiliates) shall not assign, transfer, convey or otherwise grant to any Person or otherwise encumber (including through lien, charge, security interest, mortgage, encumbrance or otherwise) (i) any rights to any NewLink Know-How or NewLink Patent Rights (or any rights to any intellectual property that would otherwise be included in the NewLink Know-How or NewLink Patent Rights), in any manner that is inconsistent with or would interfere with the grant of the rights or licenses to Merck hereunder, or (ii) any rights to any Compounds or Products (provided that NewLink shall grant to Merck the rights to the Compounds and Products as set forth herein). Without limiting the foregoing, [*] any Compounds or Products [*], except for [*] to be [*] as set forth in the [*] shall not [*] to any Third Parties [*].

3.5	Development, Manufacturing and Commercialization.

3.5.1	General. Merck (and its Affiliates), either itself or with or through Third Party(ies), shall have the sole right to (and shall control all aspects of) Develop and Commercialize Compounds and Products in accordance with the terms of this

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3.5.2

Booking of Sales; other Commercialization. Without limiting the generality of the provisions of Section 3.5.1, Merck (and its Affiliates), either itself or with or through Third Party(ies), shall have the sole right to, and shall control all aspects of, (i) handling all returns, recalls, order processing, invoicing and collection, distribution, inventory and receivables arising from sales to Third Parties, in each case, with respect to Product, (ii) booking of sales of Product, and (iii) establishing and modifying the terms and conditions with respect to the sale of the Product, including any terms and conditions relating to the price (including discounts) at which the Product will be sold.

3.6	Progress Updates. At the written request of NewLink (but no more than [*]), Merck will provide to NewLink an update on the progress of its Development activities related to Product.

3.7

Regulatory Matters. In the event that Merck determines that any regulatory filings for any Compounds or Products are required for any activities hereunder (including any activities under the Transition Program), including INDs, BLAs and other Marketing Authorizations (as applicable), then as between the Parties, Merck (or its Affiliate or Related Party or other designee) shall have the sole right, in its discretion, to obtain such regulatory filings (in its (or its Affiliate’s or its Related Party’s or other designee’s) name) and as between the Parties, Merck (or its Affiliate or its Related Party or other designee) shall be the owner of all such regulatory filings. As between the Parties, Merck (or its Affiliate or Related Party or other designee) shall have the sole right to communicate and otherwise interact with Regulatory

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3.8	Excused Performance. The obligation of Merck with respect to any Product under Section 3.5 is [*] of the [*], and the obligation of Merck to develop or commercialize any such Product [*].

3.9	No Implied Licenses. Except as specifically set forth in this Agreement, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise, in any Confidential Information disclosed to it under this Agreement or under any patents or patent applications owned or Controlled by the other Party or its Affiliates.

3.10	Third Party Funding.

3.10.1

Government Funding Opportunities. Each Party shall [*] for the Development, Manufacturing or Commercialization of Product of which it becomes aware during the Transition Period. The Parties will [in good faith discuss each such opportunity] and determine [which Party has the capabilities and resources to obtain such funding]. Unless otherwise agreed by the Parties, Merck [shall be given the opportunity (but Merck shall not be obligated) to pursue such funding opportunity (and NewLink shall not pursue any such funding opportunity unless approved by Merck in writing)] and NewLink [shall not be obligated to pursue any funding opportunity (except as expressly set forth in the following proviso) unless it agrees otherwise]; provided that, notwithstanding the foregoing, but subject to Section 3.11, NewLink [*] (the [*], the “NewLink Future Funding Agreements” and together with the NewLink Existing Funding Agreements, the “NewLink Funding Agreements”). Subject to Section 3.10.2, [*] under this Section 3.10.1 shall [*] with which it [*].

3.10.2	NewLink Agreements. NewLink shall be responsible for, and shall control all aspects of, the administration of the NewLink Funding Agreements; provided that [*] with respect to the [*] and [*] with respect to the [*], including to allow [*] under

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3.10.3

Activities and Materials under NewLink Funding Agreements. NewLink shall be responsible for compliance with the terms of the NewLink Funding Agreements; provided that Merck shall have the rights as set forth in Section 3.10.2. Promptly (and no later than [*] with respect to any material Know-How or other materials and [*] with respect to all other Know-How and materials) after the creation or generation of any Know-How or other materials under any NewLink Funding Agreement, NewLink [*]. NewLink shall ensure ([*]) that Merck has the rights to use, and hereby grants to Merck and its Related Parties the rights to use, such Know-How and materials in accordance with the exercise of the license set forth in Section 3.1 (and for clarity, such Know-How and materials shall be included in the licenses granted under Section 3.1); provided that, to the extent that NewLink [*] in and to any [*], NewLink shall, [*] (the “[*]”) (and in such case, such [*] shall not be included in the licenses granted under Section 3.1); provided further that, Merck (and its Related Parties) shall only [*] in connection with the Compounds and Products.

3.10.4

Merck Agreements. Merck will use Commercially Reasonable Efforts to establish [*] by the end of the Transition Period. Following the expiration of the Transition Period (or prior to the expiration of the Transition Period, if agreed to by the Parties), at the written request of Merck, NewLink shall [*], and in connection therewith, NewLink shall [*] Merck (or its Affiliate), including [*]; provided that (i) NewLink shall not [*] to the extent any [*] to provide [*] and (ii) NewLink shall not [*] provide any [*] unless such [*].

3.11	Additional NewLink Third Party Agreements. NewLink shall [*] after the Effective Date [*] not to be [*]. In connection therewith, (i) NewLink shall [*] and (iii) [*] of any such [*].

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ARTICLE 4	CONFIDENTIALITY AND PUBLICATION

4.1

Non-Disclosure and Non-Use Obligation. All Confidential Information disclosed by one Party to the other Party or its Affiliate hereunder shall be maintained in confidence by the receiving Party and shall not be disclosed to any Third Party or used for any purpose except as set forth herein, without the prior written consent of the disclosing Party, except to the extent that such Confidential Information:

(a)	is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records;

(b)	is in the public domain by use and/or publication before its receipt from the disclosing Party, or thereafter enters the public domain through no fault of the receiving Party;

(c)	is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or

(d)	is independently developed by the receiving Party without access to or reference to Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records contemporaneous with such development.

4.2	Permitted Disclosures. Notwithstanding Section 4.1, a receiving Party shall be permitted to disclose Confidential Information of the disclosing Party, if such Confidential Information:

(a)

is disclosed to governmental or other regulatory agencies in order to obtain patents or to gain or maintain approval to conduct clinical trials or to market Product under this Agreement, in each case, in accordance with this Agreement, but such disclosure may be only to the extent reasonably necessary to obtain patents or authorizations, and provided that reasonable steps are taken to ensure confidential treatment of such Confidential Information (if available);

(b)	is disclosed by the receiving Party (or its Affiliates) to Related Parties, agent(s), consultant(s), and/or other Third Parties for any and all purposes the receiving Party or its Affiliates deem necessary or advisable in the course of conducting activities in accordance with this

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(c)

is deemed necessary by counsel to the receiving Party to be disclosed to such Party’s attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the receiving Party, on the condition that such attorneys, independent accountants and financial advisors agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement;

(d)

is deemed necessary by the receiving Party to be disclosed in connection with a potential or actual financing, merger or acquisition of the receiving Party (or its Affiliate), in which case such Party shall have the further right to disclose Confidential Information to Third Parties involved in such financing, merger or acquisition, provided that such Third Parties agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement; or

(e)	is required by the terms of the NewLink Canada License to be disclosed to Public Health Canada to satisfy NewLink’s or Merck’s, as applicable, obligations to report any required information, on the condition that, Public Health Canada be bound by terms of confidentiality and non-use provisions with respect to such information, as specified in the NewLink Canada License.

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4.3	Know-How; Joint Know-How. Without limiting the provisions of Section 4.1, with respect to any [*], subject to Section 4.1.

4.4	Ownership of Confidential Information. For the purposes of this Article 4, where pursuant to the terms of this Agreement one Party owns Confidential Information that has been generated by the other Party, then such Confidential Information shall be treated as if it had been generated by such owning Party and disclosed by such owning Party to such other Party.

4.5

Terms of Agreement. Neither Party nor its Affiliates shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party, except as follows: A Party and its Affiliates may disclose the terms or conditions of this Agreement (but not any other Confidential Information, which may be disclosed only as described elsewhere in this Article 4), (a) on a need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably necessary; provided that such advisors are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or are bound by written agreements providing for confidentiality and non-use obligations, in each case, that are no less stringent than those confidentiality and non-use provisions contained in this Agreement; (b) to a Third Party in connection with a potential or actual (i) merger, consolidation or similar transaction by such Party or its Affiliates, (ii) sale of all or substantially all of the assets of such Party or its Affiliates (or, with respect to Merck, sale of all or substantially all of the assets of Merck to which this Agreement relates) or (iii) financing; provided that, in each case, the disclosing Party shall ensure that such Third Party is bound by confidentiality and non-use obligations with respect to Confidential Information of the other Party no less restrictive than those contained in this Agreement and such disclosing Party shall be fully liable to the other Party for breach of the confidentiality and non-use obligations under this Agreement by such Third Parties; (c) to the United States Securities and Exchange Commission or any other securities exchange or governmental authority, including as required to make an initial or subsequent public offering; or (d) as otherwise required by Applicable Law; provided that in the case of (c) and (d) the disclosing Party shall (x) submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than [*] prior to the anticipated date of disclosure, unless such shorter period is reasonably necessary to comply with Applicable Law) so as to provide a reasonable opportunity to comment on any such required disclosure, (y) if requested by such other Party, seek, or cooperate with such Party’s efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent

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4.6	Publicity/ Use of Names; Press Releases.

4.6.1

General. The Parties have mutually agreed on the press release with respect to this Agreement, a copy of which is set forth in Schedule 4.6. Either Party may make subsequent public disclosures that are limited to the specific contents of such press release. Except as otherwise expressly set forth herein, no disclosure of the terms of this Agreement may be made by either Party (or its respective Affiliates), and no Party (or its respective Affiliates) shall use the name, trademark, trade name or logo of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Applicable Law, including the rules of any securities exchange or market on which a Party’s securities are listed or traded; provided that in the event disclosure is required by Applicable Law, the disclosing Party shall use good-faith efforts to give the non-disclosing Party an opportunity, with reasonable advance notice, as practicable under the circumstances, to review and comment on any proposed disclosure.

4.6.2

NewLink Publicity. NewLink shall not issues any other press release or public announcement related to the Transition Program and/or any Compound or Product without the prior written approval of Merck; provided that if (i) such press release or public announcement is required by Applicable Law or (ii) the failure to issue such press release or public announcement would cause NewLink to breach a NewLink Funding Agreement, then NewLink may issue such press release or public announcement; provided that NewLink shall provide a copy thereof to Merck at least [*] prior to the proposed publication thereof (or with as much advance notice as possible under the circumstances if it is not possible to provide at least [(] notice). Merck shall be allowed to review and comment on such proposed publication and

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4.6.3

Merck Publicity. During the Transition Period, Merck may not issue any other press release or public announcement relating to the Transition Program and/or any Compound or Product, without providing NewLink a copy of such proposed press release or public announcement at least [*] prior to the proposed publication thereof (or with as much advance notice as possible under the circumstances if it is not possible to provide at least [*] notice), and in connection therewith, NewLink shall be allowed to review and comment on such proposed publication and Merck shall reasonably consider any comments provided by NewLink with respect thereto in a timely fashion. Following the Transition Period, Merck may issue any press release or public announcement relating to the Transition Program and/or any Compound or Product; provided that, to the extent practicable, Merck shall notify NewLink thereof at least [*] prior to the proposed publication thereof (or with as much advance notice as possible under the circumstances if it is not possible to provide at least [*] notice).

4.7

Publications. NewLink shall publish scientific information related to the Compounds or Products (including the results of the Transition Program), only with the prior written consent of Merck]; provided that if [*], then NewLink may make such publication; provided that NewLink shall [*] on any [*] and [*]. Merck shall have the right to publish information related to the Compounds and Products (including the results of the Transition Program) [*].

4.8	Clinical Trial Registration. Notwithstanding the foregoing, in all cases, Merck shall have the right to register clinical trials and publish the results or summaries of results of any clinical trials conducted hereunder with respect to Compound or Product on clinicaltrials.gov or other similar registry.

4.9	Remedies. Each Party shall be entitled to seek, in addition to any other right or remedy it may have, at law or in equity, a temporary injunction, without the posting of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Article 4.

4.10

Prior Non-Disclosure Agreements. As of the Effective Date, the terms of this Article 4 shall supersede (i) the Existing Confidentiality Agreement and (ii) the Tri-Party Confidentiality Agreement (but solely to the extent that the Tri-Party Confidentiality Agreement applies as between Merck on the one hand, and NewLink and NL, on the other hand), and, this Article 4 shall apply to any confidential information disclosed by a Party

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ARTICLE 5	PAYMENTS AND REPORTS

5.1	Upfront Payment. In consideration of the license and other rights granted to Merck herein, Merck shall pay to NewLink, within [*] following the Effective Date, a one-time, non-refundable upfront payment in the amount of Thirty Million Dollars ($30,000,000).

5.2	Milestone Payment. Subject to the terms and conditions of this Agreement, Merck shall pay to NewLink a one-time, non-refundable payment in the amount of Twenty Million Dollars ($20,000,000) (the “Milestone Payment”) within [*] following [*] as [*] (the “Milestone Event”).

5.3	[*].

5.3.1

[*]. If, at any time during the Term, [*] Merck or a Related Party [*] or to [*] (the “[*]”), [*] shall promptly notify the other Party thereof. If Merck or a Related Party [*], then, upon [*], to the extent legally permissible, Merck (or such Related Party, as applicable) shall [*], and in connection therewith, the Parties [*] of such [*]. In all cases (whether [*] was received by [*] or [*] of its intent to [*], then [*] in the [*] plus [*] in connection with [*] in connection with [*], and [*] a Third Party, then [*], and [*] not to [*], and [*] of any and all [*] in connection with [*] by Merck (or its Related Party) solely in connection with [*]. For clarity, the provisions of this Section 5.3 shall only apply with respect to [*], and [*]. As used in this Section 5.3.1, the term “[*]” shall mean [*], which shall be mutually agreed to by the Parties [*]; provided that if [*], then [*] to each of the Parties.

5.3.2

[*]. If, at any time during the Term, [*] Merck or a Related Party [*] or to [*] (the “[*]”), [*] shall promptly notify the other Party thereof. If Merck or a Related Party [*], then, upon [*], to the extent legally permissible, Merck (or such Related Party, as applicable) shall [*], and in connection therewith, the Parties [*]. In all cases (whether [*] was received by [*] or [*] of its intent to [*], then [*] in the [*] plus [*] in connection with [*] in connection with [*], and [*] to a Third Party, then [*], and [*] not to [*], and [*] of any and all [*] in connection with [*] by Merck (or its Related Party) solely in connection with [*]. For clarity, the provisions of this Section 5.3 shall only apply with respect to [*], and [*]. As used in this Section 5.3.1, the term “[*]” shall mean [*], which shall be mutually agreed to by the Parties [*]; provided that if [*], then [*] to each of the Parties.

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5.3.3	Obligation to [*]. Merck shall, upon NewLink’s reasonable request [*], undertake [*] to [*] or [*] that may be available to [*].

5.3.4	Tax Matters. Upon the issuance of [*] or [*], the Parties shall discuss in good faith [*] under this Section 5.3.4 [*].

5.4	Royalty Payments.

5.4.1

Royalty Rates. Subject to the other terms of this Section 5.4, on a Product-by-Product basis, during the Royalty Term for a given Product in a given country in the Royalty Bearing Territory, Merck shall make, on a Calendar Year basis, royalty payments to NewLink on the Product Net Sales of such Product in a given Calendar Year in such countries at the applicable royalty rate set forth below (which royalty rates shall be different for the Current Product and for any other Product as set forth below). For clarity, the royalties (and royalty tiers) shall be calculated separately on a Product-by-Product basis.

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5.4.2

Royalty Term. Merck’s royalty payment obligations under this Agreement with respect to a given Product shall commence upon [*] in the Field anywhere in the Royalty Bearing Territory by Merck or Related Parties, and shall continue, (i) with respect to the [*] Product, on a Product-by-Product basis, until [*] expiration of the last to expire Valid Claim included in NewLink Patent Rights [*] that Covers such Product, and (ii) with respect to [*], on a Product-by-Product and country-by-country basis, until the later of (x) the expiration of the last to expire Valid Claim included in NewLink Patent Rights in the country of sale that Covers such Product in such country or (y) [*] after the [*] of such Product in such country (the “Royalty Term”).

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5.4.3	Royalty Reduction.

(c)

Know-How Royalty. Subject to Section 5.4.3(c) below, if a Product is generating Product Net Sales in a country in the Royalty Bearing Territory during the Royalty Term at a time when there is no Valid Claim (i) with respect to the [*] Product, included in the NewLink Patent Rights [*] that Covers such Product, [* (ii) with respect to [*]than the [*] Product, included within the NewLink Patent Rights in such country that Covers such Product in such country, then the royalty rate applicable to Product Net Sales of such Product in such country in the Royalty Bearing Territory pursuant to Section 5.4.1 thereafter shall be reduced by [*].

(d)

Reduction for Third Party Payments. Subject to Section 5.4.3(c) and 5.4.3(d) below, Merck or any Related Party obtains a right or license under any intellectual property of a Third Party (whether prior to, or after, the Effective Date), where the research, development, making, using, selling, offering for sale, or importing of Product (or Compound contained in such Product) by Merck or any Related Party would result in a payment to such Third Party, then Merck may deduct from the royalty payment that would otherwise have been due under this Section 5.4 with respect to Product Net Sales of such Product in a particular Calendar Quarter, an amount equal to [*] pursuant to such right or license in connection with the research, development, making, using, selling, offering for sale, or importing of Product (or Compound contained therein) during such Calendar Quarter; provided, however, that in no event shall the royalties payable on Product Net Sales of Product be reduced by more than [*] in any Calendar Quarter by operation of this Section 5.4.3(b) (provided, however, that [*] as a result of [*] shall be [*] with respect to such [*]).

(e)

Payments to Public Health Canada by Merck. Notwithstanding anything to the contrary contained herein, in the event that Merck (or its Related Party, as applicable) pays any royalties or other amounts directly to Public Health Canada in connection with any Compound or Product (or the research, development, making, using, selling, offering for sale, or importing thereof), then (i) [*], and [*] and (ii) to the extent that Merck [*] from the [*] to NewLink in a [*], then NewLink [*] for the [*].

(f)

Minimum Royalty Rate. Notwithstanding the foregoing provisions of this Section 5.4.3 (but subject to Section 5.4.3(c) and 5.4.6), for so long as NewLink [*] as a result of sales of Product by Merck or its Related Parties in the Royalty Bearing Territory hereunder, in no event shall the royalty rate payable by Merck under this Section 5.4 due on Product Net Sales hereunder be reduced pursuant to the foregoing provisions of this Section 5.4.3 to less than [*], including [*]; provided that, for clarity, the provisions of this Section 5.4.3(d) are not intended to, and shall not be interpreted to, expand Merck’s royalty obligations hereunder

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5.4.4	Change in Sales Practices. The Parties acknowledge that during the term of this Agreement, Merck’s sales practices for [*] to the extent [*] may become [*]. In such event, at the request of Merck, the Parties [*] to the extent currently contemplated under this Section 5.4.

5.4.5	Royalties for Bulk Compound. In those cases in which Merck (or its Related Party) sells bulk Compound rather than Product in packaged form to an independent Third Party, the royalty obligations of this Section 5.4 shall be applicable to the bulk Compound only (but solely to the extent that a royalty would otherwise by payable on the Product incorporating such Compound).

5.4.6

[*]. If [*] with respect to Product in any country in the Royalty Bearing Territory [*], then the [*] in such country [*] shall be [*] and in such case, [*]; provided that if as a result of this Section 5.4.6, the royalty rate on Product Net Sales of such Product in such country [*] (or [*], including taking into account [*]), then for so long as [*] pursuant to the [*] hereunder in such country in the Royalty Bearing Territory (and provided that [*] is still in effect with respect to [*]), then the Parties [*] between the [*] on such [*] and the [*] with respect to [*] in such country.

5.4.7	Additional Conditions. All royalties are subject to the following conditions:

(a)	that only one royalty shall be due with respect to the same unit of Product; and

(b)	that no royalties shall be due upon the sale or other transfer among Merck or its Related Parties, but in such cases the royalty shall be due and calculated upon Merck’s or its Related Party’s Product Net Sales to the first independent Third Party; and

(c)	the determination of whether a royalty will be calculated and payable hereunder shall be determined on a Product-by-Product basis.

5.4.8

Royalty Reports and Payments. Within [*] after each Calendar Quarter, commencing with the Calendar Quarter during which the First Commercial Sale of the first Product is made anywhere in the Royalty Bearing Territory, Merck shall provide NewLink with a report that contains the following information for the applicable Calendar Quarter, on a Product-by-Product and country-by-country basis for the Royalty Bearing Territory: (i) the amount of gross sales of the Products, (ii) a reconciliation between gross sales and Product Net Sales, as specified in the definition thereof, and (iii) a calculation of the royalty payment due on such sales,

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5.4.9

Currency Exchange. All payments to be made by a Party under this Agreement shall be made in Dollars, by wire transfer, pursuant to the instructions of the Party receiving payment, as designated from time to time. The wire instructions for NewLink are set forth on Schedule 5.4.9 (which instructions may be updated in writing by NewLink to Merck). For purposes of calculating the net royalty obligation, to the extent Product is sold in a currency other than Dollars, the amount received shall be converted into Dollars on a monthly basis using as a rate of exchange [*].

5.5	Records and Audits.

5.5.1

Merck shall (and shall cause its Affiliates to) maintain complete and accurate records in sufficient detail to permit NewLink to confirm the accuracy of the royalty payments under this Agreement. Upon reasonable prior notice, such records shall be open during regular business hours for a period of [*] from the creation of individual records for examination by an independent international certified public accountant selected by NewLink and reasonably acceptable to Merck for the sole purpose of verifying for NewLink the accuracy of the royalty reports furnished by Merck pursuant to this Agreement or of any royalty payments made, or required to be made by Merck pursuant to this Agreement. Such audits shall not occur more often than [*] each Calendar Year. Such auditor shall not disclose Merck’s Confidential Information to NewLink, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Merck or the amount of payments by Merck under this Agreement. If the accountant correctly identifies a discrepancy, any amounts shown to be owed but unpaid (or overpaid, as applicable) shall be paid by the applicable Party within [*] after the accountant’s report. NewLink shall bear the full cost of such audit unless such audit reveals an underpayment by Merck that resulted from a discrepancy in the financial report provided by Merck for the audited period, which underpayment was more than [*], in which case Merck shall reimburse NewLink for the fees of the accountant for such audit.

5.5.2	Upon the expiration of [*] following the end of any Calendar Year, the calculation royalties payable with respect to such Calendar Year shall be binding and conclusive

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5.5.3

NewLink shall treat all financial information subject to review under this Section 5.5 in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with Merck and/or its Affiliates obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

5.6	Taxes.

5.6.1	Generally. Each Party will pay any and all taxes levied on account of all payments it receives under this Agreement except as otherwise provided in this Section 5.7.

5.6.2

Transfer Taxes. [*] shall be liable for all transfer taxes (including value added tax (VAT), Canadian Goods and Services taxes (GST), sales and use tax, and other similar taxes), including interest (“Transfer Taxes”) imposed upon any [*] under this Agreement, including this Article 5. The Parties shall reasonably cooperate in accordance with Applicable Laws to (i) minimize Transfer Taxes payable in connection with this Agreement and (ii) ensure all tax returns relating to Transfer Taxes are properly filed.

5.6.3

Income Tax Withholding. If Applicable Laws require that taxes be withheld with respect to any payments by under this Agreement, the payor will: (a) deduct those taxes from the remittable payment, (b) pay the taxes to the proper taxing authority, and (c) send evidence of the obligation together with proof of tax payment to the payee on a timely basis following that tax payment. Each Party agrees to reasonably cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect. The Parties shall discuss applicable mechanisms for minimizing such taxes to the extent possible in compliance with Applicable Laws.

5.7

NewLink Third Party Agreements. Notwithstanding anything to the contrary herein, [*], NewLink shall be solely responsible for (and [*] to the extent [*]) all costs and payments of any kind (including all upfront fees, annual payments, milestone payments and royalty payments) arising under any NewLink Third Party Agreements in connection with the Development, Manufacture, Commercialization or other exploitation of Compounds and/or Products hereunder.

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ARTICLE 6	REPRESENTATIONS AND WARRANTIES

6.1	Representations And Warranties Of Each Party. Each Party represents and warrants to the other Party that as of the Effective Date:

6.1.1	such Party is duly organized and validly existing under the laws of the state or jurisdiction of its organization and has full corporate power and authority to enter into this Agreement and to perform its obligations hereunder;

6.1.2

the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by the necessary corporate actions of such Party. This Agreement has been duly executed by such Party. This Agreement and any other documents contemplated hereby constitute valid and legally binding obligations of such Party enforceable against it in accordance with their respective terms, except to the extent that enforcement of the rights and remedies created thereby is subject to bankruptcy, insolvency, reorganization, moratorium and other similar laws of general application affecting the rights and remedies of creditors; and

6.1.3

the execution, delivery and performance by such Party of this Agreement and any other agreements and instruments contemplated hereunder will not (i) in any respect violate any statute, regulation, judgment, order, decree or other restriction of any governmental authority to which such Party is subject, (ii) violate any provision of the corporate charter, by-laws or other organizational documents of such Party, or (iii) constitute a violation or breach by such Party of any provision of any material contract, agreement or instrument to which such Party is a party or to which such Party may be subject although not a party.

6.2	Additional NewLink Representations and Warranties. NewLink represents and warrants to Merck that as of the Effective Date:

6.2.1	NewLink and NL each has the full right, power and authority to enter into this Agreement, to perform the activities hereunder (including the Transition Program) and to grant the license set forth in Section 3.1.1 and Section 3.2;

6.2.2	there are no claims, judgments or settlements against or owed by NewLink (or any of its Affiliates) and no pending or, to NewLink’s knowledge, threatened claims or litigation, in each case, relating to the NewLink Patent Rights and/or NewLink Know-How and/or Compounds and/or Products;

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6.2.3

Schedule 1.79 sets forth a true, correct and complete list of NewLink Patent Rights existing as of the Effective Date and such schedule contains all application numbers and filing dates, registration numbers and dates, jurisdictions and owners. The NewLink Patent Rights and NewLink Know-How constitute [*], the Compounds and/or Products or the Development, Manufacture, Commercialization and/or use thereof, or the performance of the Transition Program;

6.2.4	all issued patents within the NewLink Patent Rights are in full force and effect, and, [*], in whole or in part;

6.2.5	it (and its Affiliates) has not prior to the Effective Date (i) assigned, transferred, conveyed or otherwise encumbered its right, title and/or interest in NewLink Patent Rights or NewLink Know-How, or (ii) otherwise granted any rights to any Third Parties that would, in the case of clauses (i) and/or (ii), conflict with the rights granted to Merck hereunder;

6.2.6	to NewLink’s knowledge, [*];

6.2.7	it [*] the NewLink Patent Rights and NewLink Know-How, all of which are, as at the Effective Date, [*];

6.2.8	neither it nor any of its Affiliates has received any written notification from a Third Party that the research, development, manufacture, use, sale or import of Compounds or Products infringes or misappropriates the Patent Rights or Know-How owned or controlled by such Third Party, and NewLink has no knowledge that a Third Party has any basis for any such claim;

6.2.9	NewLink has [*] regarding [*], including [*], and [*];

6.2.10	NewLink has [*] related to NewLink Patent Rights or NewLink Know-How licensed under this Agreement;

6.2.11	NewLink has [*] Compound and/or Product [*] from any [*] or any [*] in any [*], or any other [*] to NewLink or any of the Affiliates [*], or [*] subject of any [*], in each case, with respect to [*] related to the [*];

6.2.12	other than [*] or any other [*] for any Compounds or Products, and, to the best of NewLink’s knowledge, [*] for any Compounds or Products. The [*] and neither NewLink nor any of its Affiliates [*];

6.2.13	NewLink has obtained all necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by it as of the

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6.2.14

NewLink (and its Affiliates) has not employed or otherwise used in any capacity, and will not (during the Transition Program) employ or otherwise use in any capacity, the services of any Person suspended, proposed for debarment or debarred under United States law, including under 21 USC 335a or any foreign equivalent thereof, with respect to the Compounds or Products or otherwise in performing any portion of the Transition Program (or any portion of the NewLink Funding Agreements);

6.2.15	all [*] related to the Compounds and/or Products [*] and, to NewLink’s knowledge, all [*] related to the Compounds and/or Products [*] in accordance with all Applicable Laws;

6.2.16

all information and data provided by or on behalf of NewLink to Merck on or before the Effective Date in contemplation of this Agreement was and is true and accurate and complete in all material respects, and NewLink has not disclosed, failed to disclose, or cause to be disclosed, any material information or data that would reasonably be expected to cause the information and data that has been disclosed to be misleading in any material respect;

6.2.17	it [*];

6.2.18	other than [*], there are no [*] or other [*] the NewLink Know-How or NewLink Patent Rights;

6.2.19	with respect to each NewLink Existing Third Party Agreement and each NewLink Future Funding Agreement [*] it is in full force and effect; [*] to such [*] or [*] from the [*] any of the [*], and [*] which could [*] the scope of [*] any of the [*]; and [*] relating to any [* or any other [*];

6.2.20	the [*] provided to Merck [*] in accordance with [*]. Such [*] is not [*] and is not [*], under the [*]. All such [*];

6.2.21	Schedule 6.2.21 sets forth [*] by NewLink to be [*] (the “Product Materials”);

6.2.22	Other than the [*], neither NewLink nor any of its Affiliates has [*], and with respect to the [*], NewLink has [*] under the [*];

6.2.23	Except with respect to [*], neither NewLink nor its Affiliates [*] for the [*], in each case, other than with respect to the Current Compound and Current Product;

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6.2.24	No Know-How or other intellectual property within the NewLink Know-How or NewLink Patent Rights [*];

6.2.25	Except with respect to the rights expressly retained by Public Health Canada under the NewLink Canada License, [*] Know-How, Patent Rights or other intellectual property [*], and, except with respect to the rights expressly retained by Public Health Canada under the NewLink Canada License [*] to any such [*]; and

6.2.26	NewLink is a wholly-owned subsidiary of NL, and, except as set forth on Schedule 6.2.26, there are no other Affiliates of either NewLink or NL.

6.3	Additional Merck Representations and Warranties.

6.3.1	Merck represents and warrants to NewLink that as of the Effective Date, Merck has determined pursuant to 16 C.F.R. Sec. 801.10 that no filing is required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended and the rules promulgated thereunder, with respect to the subject matter of this Agreement.

6.4

Warranty Disclaimer. EACH PARTY HEREBY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED HEREIN NOT EXPRESSLY MADE IN THIS AGREEMENT TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAWS, INCLUDING WITH RESPECT TO THE COMPOUNDS, PRODUCTS, OR ANY TECHNOLOGY OR OTHER INTELLECTUAL PROPERTY LICENSED OR GRANTED UNDER THIS AGREEMENT, INCLUDING ANY WARRANTY OF NON-INFRINGEMENT, QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. FOR THE AVOIDANCE OF DOUBT, NOTHING CONTAINED IN THIS SECTION 6.4 SHALL OPERATE TO LIMIT OR INVALIDATE ANY EXPRESS REPRESENTATION OR WARRANTY CONTAINED HEREIN.

6.5	NewLink Third Party Agreements. NewLink represents and warrants to Merck that [*] and [*], and [*] as of the Effective Date. NewLink [*] (a) [*] in full force and effect, [*]; (b) [*] has been [*] any of the [*]; (c) [*] of any [*] any of the [*] or [*], made by [*] and (d) to the extent [*], it shall promptly [*] of all other [*] to such [*] related to such [*].

6.6	[*]. During the period from the Effective Date until [*], each Party agrees and covenants to [*] or the Parties [*]; provided, however, that [*] such Party [*]. A violation of [*] may be [*].

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ARTICLE 7	INTELLECTUAL PROPERTY

7.1

Ownership of Background Technology. As between the Parties, any NewLink Know-How existing prior to the Effective Date and owned by NewLink shall, during the Term and upon expiration or termination of this Agreement, continue to be owned exclusively by NewLink. As between the Parties, any Merck Know-How shall, during the Term and upon expiration or termination of this Agreement, continue to be owned exclusively by Merck.

7.2	Program Know-How.

7.2.1

Ownership. For purposes of determining ownership under this Section 7.2.1, inventorship of Program Know-How and Program Patent Rights shall be determined in accordance with United States patent laws (regardless of where the applicable activities occurred). Notwithstanding the foregoing, all right, title and interest in any Program Know-How and Program Patent Rights, in each case, shall be determined in accordance with the following terms and conditions:

(a)

As between the Parties, NewLink shall own all right, title and interest in any Program Know-How (and Program Patent Rights that claim or cover such Program Know-How) that is conceived, discovered or reduced to practice solely by one or more employees, agents or consultants of NewLink, its Affiliates, or its subcontractors (but excluding Merck (or its Affiliates) as a subcontractor of NewLink under any NewLink Funding Agreement) (such Program Know-How, the “NewLink Program Know-How” and such Program Patent Rights, the “NewLink Program Patent Rights”);

(b)

As between the Parties, Merck shall own all right, title and interest in any Program Know-How (and Program Patent Rights that claim or cover such Program Know-How) that is conceived, discovered or reduced to practice solely by one or more employees, agents or consultants of Merck, its Affiliates, or its subcontractors (such Program Know-How, the “Merck Program Know-How” and such Program Patent Rights, the “Merck Program Patent Rights”); and

(c)

NewLink and Merck shall jointly own all right, title and interest in any Program Know-How (and Program Patent Rights that claim or cover such Program Know-How) that is conceived, discovered or reduced to practice by one or more employees, agents or consultants of NewLink, its Affiliates, or its subcontractors, together with one or more employees, agents or consultants of Merck, its Affiliates, or its subcontractors (such Program Know-How, the “Joint Program Know-How” and such Program Patent Rights, the “Joint Program Patent Rights”). Subject to the licenses granted to the other Party under this Agreement and the other terms of this Agreement, each Party has a right to exploit its interest in such Joint

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7.2.2

Assignment of Interests to Effectuate Ownership of Joint Program Know-How and Joint Program Patent Rights. With respect to any Joint Program Know-How and Joint Program Patent Rights, each of NewLink and Merck shall on behalf of itself and each of their respective Affiliates, employees and contractors hereunder, assign to one another (without payment of additional consideration), in perpetuity throughout the world, ownership of an undivided interest in and to such Program Know-How and Program Patent Rights if necessary to effect the ownership of such Program Know-How and Program Patent Rights as set forth in Section 7.2.1(c), subject to any licenses expressly granted under this Agreement. In furtherance of the foregoing, each Party shall, upon request by the other, promptly undertake and perform (and/or cause its Affiliates and its and their respect employees and/or agents to promptly undertake and perform) such further actions as are reasonably necessary for NewLink and Merck to, as between the Parties, perfect its title in any such Program Know-How and Program Patent Rights as set forth in Section 7.2.1(c), as, and to the extent, applicable, including by causing the execution of any assignments or other legal documentation, and/or providing the other Party or its patent counsel with reasonable access to any employees or agents who may be inventors of such Program Know-How and Program Patent Rights.

7.3	Filing, Prosecution and Maintenance of Patent Rights.

7.3.1	Joint Program Patent Rights and NewLink Patent Rights.

(a)

Joint Program Patent Rights and NewLink Patent Rights. With respect to any Joint Program Patent Rights and any NewLink Patent Rights, [*] shall have the first right (in its discretion), at its cost, to Prosecute such Patent Rights in the name of both Parties (with respect to Joint Program Patent Rights) or NewLink (with respect to NewLink Patent Rights); provided, however, that [*] shall only have the right to Prosecute [*] and [*] to the extent such Prosecution [*]. In connection therewith, [*] as may be [*] the Joint Program Patent Rights and NewLink Patent Rights. [*] may elect to use outside counsel for such Prosecution. With respect to a given Joint Program Patent Right or NewLink Patent Right, [*] (i) may elect not to Prosecute, (ii) may elect not to Prosecute in a particular country (including electing not to validate in a particular country) and/or (iii) may elect to discontinue Prosecution in a particular country; and in case of clause (ii) or clause (iii), [*] shall provide

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(b)

Review and Consultation. With respect to the Joint Program Patent Rights and NewLink Patent Rights, upon the written request of the non-Prosecuting Party, the Prosecuting Party shall give the non-Prosecuting Party an opportunity to review the text of any application before filing, shall consult with the non-Prosecuting Party with respect thereto (and shall consider the non-Prosecuting Party’s comments thereto in good faith), and shall supply the non-Prosecuting Party with a copy of the application as filed, together with notice of its filing date and serial number. Upon request of the non- Prosecuting Party, the Prosecuting Party shall keep the other Party advised of the status of such actual and prospective patent filings and, upon such other Party’s request, shall provide advance copies of any material papers to be filed related to the filing, prosecution and maintenance of such patent filings. Each Party shall promptly give notice to the other Party of the grant, lapse, revocation, surrender, invalidation or abandonment of such Joint Program Patent Rights or NewLink Patent Rights for which it is responsible for the filing, prosecution and maintenance.

7.3.2	Merck Patent Rights. Merck shall have the sole right, in its discretion and at its own expense, to Prosecute the Merck Patent Rights, and NewLink shall have no rights in connection therewith.

7.3.3

Cooperation. As requested by the Prosecuting Party, the non-Prosecuting Party shall provide the Prosecuting Party with reasonable assistance in connection with the Prosecution of Patent Rights under this Section 7.3, including (i) giving the Prosecuting Party reasonable access to its employees, agents, consultants and subcontractors and those of the non-Prosecuting Party’s Affiliates for the purposes of identifying inventors of subject matter in any such Patent Rights, and (ii) obtaining any necessary declarations and assignments from its named inventors or those under obligation to assign inventions hereunder, and providing relevant technical reports (including, if necessary, laboratory notebooks), to the Prosecuting Party concerning the subject invention. Without limiting the foregoing, if a power of attorney from the non-Prosecuting Party is needed to facilitate the Prosecuting Party’s Prosecution

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7.3.4

Prosecution Matters. For the avoidance of doubt, all interferences, oppositions, appeals or petitions to any board of appeals in any patent office, appeals to any court for any patent office decisions, reissue proceedings, invalidation proceedings, re-examination proceedings, inter partes reviews, post grant reviews, derivation proceedings or other similar administrative proceedings or administrative appeals thereof, with respect to any Patent Rights under this Agreement shall be considered patent Prosecution matters, and shall be handled in accordance with this Section 7.3. With respect thereto, the non-Prosecuting Party shall (i) join (if required to bring such action) such action voluntarily, and (ii) execute and cause its Affiliates to execute all documents necessary for the Prosecuting Party to initiate such action in the event that the Prosecuting Party is unable to initiate or prosecute such action solely in its own name. In all cases, with respect to the Prosecution of the NewLink Patent Rights or Joint Program Patent Rights, as applicable, the Prosecuting Party shall not enter into any settlement that would oblige the non-Prosecuting Party (or any of its Related Parties) to make any payment or would have a detrimental effect on the Compounds or Products, or the rights or licenses of the non-Prosecuting Party hereunder, without the non-Prosecuting Party’s prior written consent (not to be unreasonably withheld).

7.4	Enforcement of Patent Rights.

7.4.1

NewLink Patent Rights and Joint Program Patent Rights. NewLink shall give Merck prompt written notice of either (i) any infringement of NewLink Patent Rights or Joint Program Patent Rights and/or (ii) any misappropriation or misuse of NewLink Know-How or Joint Program Know-How that may come to NewLink’s attention. Merck and NewLink shall thereafter consult and cooperate fully to determine a course of action, including the commencement of legal action by either or both Merck and NewLink, to terminate any infringement of NewLink Patent Rights or Joint Program Patent Rights or any misappropriation or misuse of NewLink Know-How or Joint Program Know-How, as applicable. However, subject at all times to any applicable terms and conditions of the NewLink Canada License with respect to NewLink Patent Rights that are owned by Public Health Canada and licensed to NewLink under the NewLink Canada License, Merck, upon notice to NewLink, shall have the first right to initiate and prosecute such legal action at its own expense (including, in the name of NewLink, if necessary) or to control the defense of any declaratory judgment action relating to NewLink Patent Rights, Joint Program Patent Rights, NewLink Know-How or Joint Program Know-How, as

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7.4.2

Cooperation. For any action to terminate any infringement of NewLink Patent Rights or Joint Program Patent Rights, or any misappropriation or misuse of NewLink Know-How or Joint Program Know-How, in the event that Merck is unable to initiate or prosecute such action solely in its own name, NewLink shall join such action voluntarily and execute and cause its Affiliates to execute all documents necessary for Merck to initiate litigation to prosecute and maintain such action. In connection with any action by Merck, NewLink shall cooperate fully with Merck and NewLink shall provide Merck with any information or assistance that Merck may reasonably request.

7.4.3	Information. In connection with the foregoing, each Party shall keep the other informed of developments in any action or proceeding, including, to the extent permissible by law, consultation on and approval of any settlement, the status of any settlement negotiations and the terms of any offer related thereto.

7.4.4	Recoveries. Subject at all times to any applicable recovery terms of the NewLink Canada License with respect to enforcement actions of the NewLink Patent Rights that are owned by Public Health Canada and licensed to NewLink under the NewLink Canada License, any recovery obtained by either or both Merck and NewLink in

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(a)	the Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action;

(b)	the other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action; and

(c)	the amount of any recovery remaining shall [*].

7.4.5	Biosimilar Applications.

(a)

Notwithstanding the foregoing provisions of this Section 7.4, if either Party receives a copy of a Biosimilar Application referencing a Product or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(9)(C), the remainder of this Section 7.4.5 shall apply. Such Party shall within [*] notify the other Party. The owner of the relevant patents shall then seek permission to view the application and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, either Party shall within [*] notify and provide the other Party copies of such communication to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application:

(i)	Merck shall designate, to the extent permitted by law, or otherwise NewLink shall designate in accordance with Merck’s instructions, the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application pursuant to 42 U.S.C. §262(l)(1)(B)(ii).

(ii)

Merck shall have the right, after consulting with NewLink, to list any patents, including those within the NewLink Patent Rights, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), to respond to any communications with respect to such lists from the filer of the Biosimilar Application, to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1) and as to the patents that will be subject to the initial litigation procedure as described in 42 U.S.C. §262(l)(4), to decide which patent or patents shall be selected for initial litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and to commence

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(iii)

Merck shall have the right, after consulting with NewLink, to identify patents, including those within the NewLink Patent Rights, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (ii) in any other jurisdiction outside of the United States. If required pursuant to Applicable Law, upon Merck’s request, NewLink shall assist in the preparation of such list and make such response after consulting with Merck.

(iv)

NewLink shall cooperate with Merck’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. Merck shall consult with NewLink prior to identifying any NewLink Patent Rights to a Third Party as contemplated by this Section 7.4.5. Merck shall consider in good faith advice and suggestions with respect thereto received from NewLink, and notify NewLink of any such lists or communications promptly after they are made.

(v)

Each Party shall within [*] after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by law, Merck shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. If required pursuant to Applicable Law, upon Merck’s request, NewLink shall assist in seeking such injunction or filing such infringement action after consulting with Merck. Except as otherwise provided in this Section 7.4.5, any such action shall be subject to the terms and conditions of Section 7.4.1 through 7.4.4 in relation to actions for infringement brought by Merck.

(vi)

The Parties recognize that procedures other than those set forth above in Section 7.4.5 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under Section 7.4.5 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 7.4.5

(b)	As used herein, the term “Biosimilar Application” means an application or submission filed with a Regulatory Authority for Marketing Authorization of a pharmaceutical or biological product claimed to be biosimilar or interchangeable to any Product or otherwise

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7.4.6

Merck Patent Rights and Merck Know-How. Notwithstanding the foregoing provisions of this Section 7.4, Merck shall have the sole right, in its discretion, to handle any action with respect to any infringement of Merck Patent Rights, or misappropriation of Merck Know-How, including that Merck shall have the sole right, in its discretion, to handle any certification matter regarding any Merck Patent Rights with respect to any Biosimilar Application as set forth in Section 7.4.5, and NewLink shall have no rights in connection with any of the foregoing. For any action with respect to any infringement of Merck Patent Rights or misappropriation of Merck Know-How (including in connection with any Biosimilar Application), in the event that Merck is unable to initiate or prosecute such action solely in its own name, NewLink shall, at Merck’s request and expense, join such action voluntarily and execute and cause its Affiliates to execute all documents necessary for Merck to initiate litigation to prosecute and maintain such action. In connection with any action, at the request of Merck, NewLink shall, at Merck’s expense, provide Merck with reasonable assistance that Merck may reasonably request. As between the Parties, any recovery obtained by Merck in connection with or as a result of any action contemplated by the provisions of this Section 7.4.6, whether by settlement or otherwise, shall be retained solely by Merck. In all cases, NewLink shall give Merck prompt written notice of any infringement of any Merck Patent Rights that may come to its attention and/or any certification regarding any Merck Patent Rights it has received or otherwise becomes aware in connection with any Biosimilar Application (and NewLink shall provide Merck with a copy of such certification within [*] of receipt).

7.5

Patent Term Extension. NewLink shall reasonably cooperate with Merck, including providing reasonable assistance to Merck (including executing any documents as may reasonably be required), in efforts to seek and obtain patent term restoration or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Joint Program Patent Rights, NewLink Patent Rights or Merck Patent Rights, including as may be available to the Parties under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 or comparable laws outside the United States of America, in each case, in connection with the Products. In the event that elections with respect to obtaining such patent term restoration or supplemental protection certificates or their equivalents are to be made in relation to Joint Program Patent Rights or NewLink Patent Rights or Merck Patent Rights, Merck shall have the right to make the election and NewLink agrees to abide by such election.

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7.6	Other Patent Cooperation. At the request of [*] shall reasonably cooperate with [*] with respect to patent protection with respect to the Program Know-How, including to take reasonable actions [*] for United States patents and patent applications, in each case, as determined by [*].

7.7

Infringement or Misappropriation Claims with Respect to Compound or Product. NewLink shall give Merck prompt written notice if any Third Party asserts, or if NewLink otherwise becomes aware, that a Third Party’s Patent Rights or Know-How may be infringed or misappropriated by the research, development, making, using, selling, offering for sale, importing, exporting or otherwise exploiting any Compounds or Products. Subject to the provisions of Section 9.1.1 (Indemnity-Merck) and 9.1.2 (Indemnity-NewLink), Merck shall have the sole right (regardless of whether notified by NewLink pursuant to the foregoing provisions of this Section 7.7), but not the obligation, using counsel of its choice, to control the defense of any infringement or misappropriation action (including any declaratory judgment action) brought by a Third Party relating to the infringement or misappropriation of a Third Party’s Patent Rights or Know-How or other intellectual property by the research, development, making, using, selling, offering for sale, importing, exporting or otherwise exploiting any Compounds or Products, and NewLink shall have no rights, and shall not take any actions, in connection therewith. In connection with any such action, NewLink shall cooperate fully with Merck and NewLink will provide Merck with any information or assistance that Merck may request, and in the event that Merck is unable to bring such action solely in its own name, NewLink shall join such action voluntarily and execute and cause its Affiliates to execute all documents necessary for Merck to bring such action.

ARTICLE 8	TERM AND TERMINATION

8.1

Term and Expiration. This Agreement shall become effective upon the Effective Date and, if not otherwise terminated earlier pursuant to this Article 8, shall expire on a Product-by-Product basis upon the expiration of the royalty payment obligations hereunder with respect to the applicable Product (the “Term”). This Agreement shall expire in its entirety (if not otherwise terminated earlier pursuant to this Article 8) on the date that this Agreement has expired with respect to all Products. Upon expiration of this Agreement with respect to a given Product under this Section 8.1, [*], and, upon expiration of this Agreement in its entirety under this Section 8.1, [*].

8.2	Other Termination.

8.2.1	Merck shall have the right to terminate this Agreement at any time in its sole discretion by giving [*] advance written notice to NewLink; provided, however, that such termination shall be effective immediately if Merck elects to terminate this

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8.2.2

If, at any time during the Term, a BLA has not been submitted for at least one (1) Product and Merck [*] for an Alternative Product, NewLink shall have the right to terminate this Agreement on [*] advance written notice to Merck with respect to all Products other than [*]; provided that such notification of NewLink’s exercise of its termination right under this Section 8.2.2 shall be provided within [*] for [*] Alternative Product. As used herein, “Alternate Product” shall mean [*].

8.3	Termination for Cause.

8.3.1	Cause for Termination. This Agreement may be terminated at any time during the Term:

(a)

upon written notice by NewLink if Merck is in material breach of (i) its Product Diligence Obligations pursuant to Section 3.5.1 by causes and reasons within its control or (ii) any obligation to make payments to NewLink hereunder, and has not cured such breach within [*] after written notice requesting cure of the breach (provided, however that such initial [*] cure period shall be extended for an additional [*] for so long as [*]; provided, however, in the event of a good faith dispute with respect to the existence of a material breach, the [*] cure period shall be tolled until such time as the dispute is resolved pursuant to Section 10.6; provided further, however, that it is agreed that termination pursuant to this Section 8.3.1(a) shall be on a Product-by-Product basis to which the breach relates and that NewLink cannot terminate this Agreement under this Section 8.3.1(a) with respect to the non-affected Products (and the effects of termination in Section 8.3.2 shall only apply with respect to such terminated Product); or

(b)

by a Party upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors, by the other Party; provided, however, that in the case of any involuntary bankruptcy proceeding such right to terminate shall only become effective if the Party consents to the involuntary bankruptcy or such proceeding is not dismissed within [*] after the filing thereof (an “Insolvency Event”).

8.3.2	Effect of Termination. Upon termination (but not expiration) of this Agreement for any reason (other than termination by Merck pursuant to Section 8.3.1(b)), all licenses and other rights granted hereunder shall terminate (except those that

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(a)

Terminated Products. Following termination NewLink may elect to receive (which election shall be made in writing to Merck within [*] following termination), and Merck hereby grants to NewLink, effective upon such election, [*]) to research, develop, import, use, make, have made, offer for sale and sell the Current Product (if this Agreement is terminated with respect to the Current Product) and any other Product [*], but excluding [*] (such Products, [*] “Terminated Products”), in each case, in the Field in the Territory. In consideration for such license, the Parties shall agree to, [*] shall be [*]. If the Parties are unable to agree [*], either Party [*] and all of [*]. Each Party shall [*], and the [*]. The Parties shall [*] and the [*]. Notwithstanding the provisions of this Section 8.3.2(a), the licenses in this Section 8.3.2(a) shall not be effective until such time as the Parties agree [*].

(b)

Regulatory Documentation. Promptly following the effective date of such termination, Merck shall transfer and assign to NewLink all of its (and its Affiliates) material Regulatory Documentation and data relating solely and exclusively to any Terminated Products (provided, however, that if there is additional Regulatory Documentation or data in Merck’s (or its Affiliates) Control related to the Terminated Products that is necessary for NewLink to continue to Develop and Commercialize such Terminated Product, then at the written request of NewLink (which request shall be made within [*] following the effective date of termination), Merck shall use Commercially Reasonable Efforts to provide NewLink with access to such Regulatory Documentation and data (provided that Merck may redact any and all portions thereof not related to the Terminated Product)), in each case, to the extent [*].

(c)	Transition Assistance. Merck shall, [*], provide the following transitional assistance upon request by NewLink:

(i)	Merck shall promptly destroy or return to NewLink all Know-How, data, materials and other Confidential Information made available to Merck by NewLink under this Agreement.

(ii)	Merck shall, at NewLink’s request, provide to NewLink (including when available, in electronic format) a copy of the physical embodiment of all Merck Know-How that is directly related to any Terminated Product and licensed to NewLink pursuant to Section 8.3.2(a); provided that NewLink shall comply with the confidentiality and non-use provisions set

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(iii)	Merck shall [*] all inventory of Terminated Product in Merck’s (or its Affiliate’s) possession, and in connection therewith, [*].

(iv)	Merck shall assign back to NewLink any [*] that relate solely and exclusively to the Terminated Product.

(v)	Merck shall assign or transfer to NewLink any manufacturing agreement between Merck and a Third Party contract manufacturer with respect to such Terminated Product, to the extent assignable (and solely to the extent that such manufacturing agreement does not relate to any other products).

(d)

[*]; Other Provisions. Notwithstanding the foregoing provisions of this Section 8.3.2, any [*] to provide [*] shall not [*]. All Regulatory Documentation, Know-How, data, information, correspondence and other items provided to NewLink pursuant to this Section 8.3.2 shall be provided [*], and shall [*]. NewLink shall provide reasonable assistance to Merck in connection with the transfer and delivery of the foregoing items.

(e)

Wind-Down. Notwithstanding the foregoing provisions of this Section 8.3.2, the licenses granted to Merck pursuant to Section 3.1 and Section 3.2 shall survive for [*] following the effective date of termination in order for Merck (and its Affiliates, sublicensees and distributors), [*], during the [*] period immediately following the effective date of termination, to (i) finish or otherwise wind-down any ongoing Clinical Trials with respect to any Compounds or Products hereunder or transfer such Clinical Trials (where Merck is permitted to do so under Applicable Laws) to NewLink and (ii) finish any work-in-progress and sell any Products or Compounds remaining in inventory, in accordance with the terms of this Agreement; provided that, for clarity, [*] and; provided further, that such licenses shall be non-exclusive.

8.3.3

Effect of Termination by Merck for Insolvency Event. In the event that this Agreement is terminated by Merck under Section 8.3.1(b) then the provisions of this Section 8.3.3 shall apply (and the provisions of Section 8.3.2 shall not apply). In the event that this Agreement is terminated due to the rejection of this Agreement by or on behalf of NewLink due to an Insolvency Event (including under Section 365 of the United States Bankruptcy Code (the “Code”), as applicable), all licenses and rights to licenses granted under or pursuant to this Agreement by NewLink to Merck are and shall otherwise be deemed to be (including for purposes of Section 365(n) of the Code, as applicable) licenses of rights to “intellectual

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8.4

Effect of Expiration or Termination; Survival. Subject to a Party’s continuing right to use and disclose Confidential Information of the other Party under the surviving license pursuant to this Article 8, if any, following expiration or any early termination of this Agreement, each Party shall destroy, and confirm in writing that is has destroyed, all Confidential Information in tangible form and substances or compositions delivered or provided by the other Party, as well as any other material provided by the other Party in any medium (provided, however, that the receiving Party may keep one copy of Confidential Information received from the other Party in its confidential legal archives to confirm compliance with the non‑use and non‑disclosure provisions of this Agreement). Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Each Party shall pay all amounts then due and owing as of the expiration or termination date. Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination. The provisions of Sections 4.1, 4.2, 4.4, 4.5, 4.6.1, 4.9 and 4.10 shall survive the expiration or termination of this Agreement and shall continue in effect for [*]. In addition, the provisions of Articles 1 (as necessary for the interpretation of the other surviving provisions), 9 and 10, and Sections 2.9.4 (but solely with respect to the penultimate sentence thereof), 2.10.1, 2.10.2, 5.3 (but solely with respect to any [*] or [*], as applicable, received during the Term, and excluding Section 5.3.3), 5.4 (solely with respect to Product Net Sales hereunder prior to the effective date of termination or Product Net Sales by Merck under Section 8.3.2(e), but in each case, solely

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ARTICLE 9	INDEMNITY; LIMITATIONS ON LIABILITY

9.1	Indemnity; Insurance.

9.1.1

Merck. Merck shall indemnify, defend and hold NewLink and its Affiliates and their respective directors, officers, employees, agents and their respective successors, heirs and assigns (the “NewLink Indemnitees”) harmless from and against any losses, costs, claims, damages, liabilities or expense (including reasonable attorneys’ and professional fees and other expenses of litigation) (collectively, “Liabilities”) arising, directly or indirectly out of or in connection with Third Party claims, suits, actions, demands or judgments (a “Third Party Claim”) relating to (a) any breach by Merck of its representations, warranties or covenants made in this Agreement, (b) the gross negligence or willful misconduct of Merck, its Affiliates or their respective officers, directors, agents or employees, in performing any obligations under this Agreement or (c) the Development, Manufacture or Commercialization of any Compound or Product by or on behalf of Merck or Related Parties; except, in each case, to the extent such Liabilities result from a breach of this Agreement by NewLink or the negligence or willful misconduct of NewLink or other NewLink Indemnitees, or to the extent NewLink has an obligation to indemnify Merck Indemnitees under Section 9.1.2(a), (b), (c), (d) or (e).

9.1.2

NewLink. NewLink shall indemnify, defend and hold Merck and its Affiliates and their respective directors, officers, employees, agents and their respective successors, heirs and assigns (the “Merck Indemnitees”) harmless from and against any Liabilities arising, directly or indirectly out of or in connection with Third Party Claims relating to (a) any breach by NewLink of its representations, warranties or covenants made in this Agreement, (b) the gross negligence or willful misconduct of NewLink, its Affiliates or their respective officers, directors, agents or employees, in performing any obligations under this Agreement, (c) the Development or Manufacture of any Compound or Product prior to the Effective Date, (d) any breach by NewLink of the NewLink Third Party Agreements; or (e) the Development, Manufacture or Commercialization of any Terminated Product; except, in each case, to the extent such Liabilities result from a breach of this Agreement by Merck, or the negligence or willful misconduct of Merck or other Merck Indemnitees, or to

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9.1.3

Procedure. If a Party is seeking indemnification under this Article 9 (the “Indemnified Party”), it shall inform the other Party (the “Indemnifying Party”) of the claim giving rise to the obligation to indemnify pursuant to this Article 9 as soon as reasonably practicable after receiving notice of the claim (provided, however, any delay or failure to provide such notice shall not constitute a waiver or release of, or otherwise limit, the Indemnified Party’s rights to indemnification under this Article 9, except to the extent that such delay or failure materially prejudices the Indemnifying Party’s ability to defend against the relevant claims). The Indemnifying Party shall have the right to assume the defense of any such claim for which it is obligated to indemnify the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party and the Indemnifying Party’s insurer as the Indemnifying Party may reasonably request, and at the Indemnifying Party’s cost and expense. The Indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnifying Party. The Indemnifying Party shall not settle any claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld. The Indemnified Party shall not settle or compromise any such claim without the prior written consent of the Indemnifying Party, which it may provide in its sole discretion. If the Parties cannot agree as to the application of Section 9.1.1 or 9.1.2 to any claim, pending resolution of the dispute pursuant to Section 10.6, the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 9.1.1 or 9.1.2 upon resolution of the underlying claim.

9.1.4

Insurance. Each Party shall procure and maintain insurance, including product liability insurance (or self-insure), adequate to cover its obligations hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Section 9.1 or otherwise. Each Party shall provide the other Party with written evidence of such insurance upon request. Each Party shall provide the other Party with written notice at least [*] prior to the cancellation, non renewal or material change in such insurance or self insurance which materially adversely affects the rights of the other Party hereunder. Notwithstanding the foregoing, the foregoing provisions shall not apply to Merck if Merck self-insures.

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9.2

Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES (INCLUDING LOST PROFITS OR LOST REVENUES) ARISING FROM OR RELATING TO THIS AGREEMENT (INCLUDING BREACH OF THIS AGREEMENT) OR THE EXERCISE OF ITS RIGHTS HEREUNDER, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 9.2 IS INTENDED TO OR SHALL LIMIT OR RESTRICT (1) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 9.1.1, 9.1.2 OR 2.9.4 IN CONNECTION WITH ANY THIRD PARTY CLAIMS, OR (2) DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 4.

ARTICLE 10	MISCELLANEOUS

10.1

Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including embargoes, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.

10.2	Assignment; Change of Control.

10.2.1

Assignment. Except as provided in this Section 10.2, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the consent of the other Party; provided, that a Party may, without such consent, assign this Agreement and its rights and obligations hereunder (i) to an Affiliate (provided, however, that a Party assigning to an Affiliate shall remain fully and unconditionally liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate), and the assigning Party shall promptly notify the other Party in writing of any such assignment, or (ii) subject to Section 10.2.3, in connection with the transfer or sale of all or substantially all of its assets to which this Agreement relates, or (iii) subject to Section 10.2.3, in connection with

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10.2.2	Exceptions to Assignment by NewLink [*]. Notwithstanding the provisions of Section 10.2.1, neither NewLink nor its Affiliate shall be permitted to assign this Agreement (or its rights and obligations hereunder) [*]. However, [*] pursuant to [*] provided that [*] (a “[*]”). For clarity, such [*] shall thereafter also be [*].

10.2.3

Change of Control of NewLink. In the event of a Change of Control of NL or NewLink (or in the event of any assignment of this Agreement by NewLink pursuant to clause (ii) of Section 10.2.1), NewLink must notify Merck in writing at least [*] prior to completion of any such Change of Control (to the extent such notification is legally permissible prior to completion of such Change of Control, and if such notification is not legally permissible prior to such Change of Control, then such notification shall be provided to Merck in writing [*] with respect to such Change of Control) or assignment, as applicable, and, where the Third Party counterparty to such Change of Control (or assignment, as applicable) is [*] (a “Competitor”), Merck shall have the right, at any time within [*] of receipt of such notice, to elect [*] upon written notice to NewLink: (i) [*]; provided that (a) [*] effective upon such termination and (b) to the extent [*] as part of the [*]; (ii) require NewLink, including its acquiring party, to adopt reasonable procedures to be agreed upon in writing with Merck, such agreement not to be unreasonably withheld, to prevent the disclosure of all Confidential Information of Merck and its Affiliates and other information with respect to the Development, Manufacturing and Commercialization of Compounds or Products (the “Sensitive Information”) beyond [*] or, where [*] in order for [*] hereunder and that [*], and to control the dissemination of Sensitive Information disclosed after the NewLink Change of Control, which procedures shall include reasonable restrictions on the scope of any Sensitive Information to be provided by Merck; (iii) [*]; (iv) [*] hereunder to [*] as is necessary for NewLink to [*]; and/or (v) request NewLink (or its Affiliate, as applicable) to [*], and in such case, [*], to the extent legally permitted, [*]. No Patent Rights, Know-How or other intellectual property rights owned or otherwise controlled by the Third Party acquiror (or any Affiliates of such Third Party prior to such Change of Control, but excluding, for clarity, NewLink and Affiliates of NewLink prior to such Change of Control) acquiring NewLink or NL pursuant to a Change of Control shall be included in the

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10.3

Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

10.4	Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

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10.5	Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York and the patent laws of the United States without reference to any rules of conflict of laws or renvoi.

10.6	Dispute Resolution.

10.6.1

The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy or claim arising from or related to this Agreement or the breach thereof. If the Parties do not fully settle, and a Party wishes to pursue the matter, each such dispute, controversy or claim that is not an “Excluded Claim” shall be finally resolved by binding arbitration in accordance with the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the American Arbitration Association (“AAA”), and judgment on the arbitration award may be entered in any court having jurisdiction thereof.

10.6.2

The arbitration shall be conducted by a panel of three persons experienced in the pharmaceutical business: within [*] after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected arbitrators shall select a third arbitrator within [*] of their appointment. If the arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by the AAA. The place of arbitration shall be New York, New York. All proceedings and communications shall be in English.

10.6.3

Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages. Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration.

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10.6.4

Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable New York law statute of limitations.

10.6.5

The Parties agree that, in the event of a dispute over the nature or quality of performance under this Agreement, neither Party may terminate this Agreement until final resolution of the dispute through arbitration or other judicial determination. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the dispute shall be refunded if an arbitrator or court determines that such payments are not due.

10.6.6	As used in this Section, the term “Excluded Claim” means a dispute, controversy or claim that concerns (a) the validity or infringement of a patent, trademark or copyright, or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.

10.7	Headings. The captions to the several Articles, Sections and subsections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.

10.8

Independent Contractors. It is expressly agreed that NewLink and Merck shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither NewLink nor Merck shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

10.9	Waiver. The waiver by either Party hereto of any right hereunder, or of any failure of the other Party to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party whether of a similar nature or otherwise.

10.10	Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

10.11	Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the

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10.12

Certain Conventions. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, Attachment or Exhibit shall be deemed to be a reference to an Article, Section, subsection, paragraph, clause, Attachment or Exhibit, of or to, as the case may be, this Agreement, unless otherwise indicated. Unless the context of this Agreement otherwise requires, (a) words of any gender include each other gender, (b) words such as “herein”, “hereof”, “hereunder” and derivative or similar words refer to this Agreement, including the Attachments, as a whole and not merely to the particular provision in which such words appear, (c) words using the singular shall include the plural, and vice versa, (d) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation”, (e) the word “or” shall not be construed as exclusive, (f) the word “law” or “laws” means any applicable, legally binding statute, ordinance, resolution, regulation, code, guideline, rule, order, decree, judgment, injunction, mandate or other legally binding requirement of a governmental authority (including a court, tribunal, agency, legislative body or other instrumentality of any (i) government or country or territory, (ii) any state, province, county, city or other political subdivision thereof, or (iii) any supranational body) and (g) references to any Articles or Sections include Sections and subsections that are part of the reference Article or section (e.g., a section numbered “Section 2.2.1” would be part of “Section 2.2.”, and references to “Article 2” or “Section 2.2.” would refer to material contained in the subsection described as “Section 2.2.2”). In addition, any payment which is deemed to be non-creditable or non-refundable shall not in any way limit Merck’s right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement.

10.13	Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. In addition, this Agreement may be executed by facsimile or “PDF” and such facsimile or “PDF” signature shall be deemed to be an original.

10.14

Entire Agreement; Amendments. This Agreement, together with the Schedules and other attachments hereto, contains the entire understanding of the Parties with respect to the Transition Program and the licenses and rights granted hereunder. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the subject matter of this Agreement, including the Transition Program and the licenses and rights granted hereunder, are superseded by the terms of this Agreement. The Schedules and other attachments to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended,

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10.15	Further Actions. Each Party will execute, acknowledge and deliver such further instruments, and to do all such other ministerial, administrative or similar acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

10.16	No Third Party Rights. The provisions of this Agreement are for the exclusive benefit of the Parties, and no other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party.

10.17	Expenses. Except as otherwise specifically provided in this Agreement, each Party (and its Affiliates) shall bear its own costs and expenses in connection with entering into this Agreement and the consummation of the transactions and performance of its obligations contemplated hereby.

10.18

Extension to Affiliates. Merck shall have the right to extend the rights, licenses, immunities and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to Merck. Merck shall remain fully liable for any acts or omissions of such Affiliates.

10.19

Parent Guarantee. This Agreement provides for the performance by NewLink, an Affiliate of NL. NL hereby unconditionally and irrevocably guarantees, and shall be fully liable for, the prompt and complete performance (including any amounts payable hereunder) of this Agreement, as may be amended from time to time, by NewLink. The performance guaranty described in this Section 10.19 shall be effective [*] as to which [*]. NL’s obligations are [*] of any [*] and it shall not be necessary for [*] as a condition to the [*]. NL, hereby [*] to [*] that any other [*] and expressly [*] that it may have [*].

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RE:	ADDENDUM TO THE LEASE BETWEEN ISU RESEARCH PARK CORPORATION AND BIOPROTECTION SYSTEMS CORPORATION DATED AUGUST 22, 2005.

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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 MARCH 1, 2010.

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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, 2014, 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.