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

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2.	Basis of Presentation

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•	Incentive Stock Options

•	Nonstatutory Stock Options

•	Restricted Stock Awards

•	Stock Appreciation Rights

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8.	Commitments and Contingencies

9.	Subsequent Events

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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 facilities and equipment related to research and development;

•	expenses incurred under agreements with contract manufacturing organizations;

•	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 and officer insurance premiums associated with being a public company;

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

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

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

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

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

•	the cost of manufacturing our product candidates and any products we commercialize, including our 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 partnerships, 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 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.

•	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;

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•	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.

•	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;

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•	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;

•	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 submit);

•	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 HyperAcute product candidates, indoximod, NLG919, or any other 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 HyperAcute product candidates, indoximod, NLG919, or any other 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 HyperAcute product candidates, indoximod, NLG919, or any other potential product; or

•	the collaborator may independently develop, or develop with third parties, products that could compete with the HyperAcute product candidates, indoximod, NLG919, or any other potential product.

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

•	we may be required to issue equity securities that would dilute our existing stockholders’ percentage ownership;

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

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

•	strategic 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;

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•	distraction of management; and

•	substantial monetary awards to plaintiffs.

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

•	actual or anticipated results from and any delays in our clinical trials, including our Phase 3 IMPRESS clinical trial of 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;

•	additions or departures of key scientific or management personnel;

•	conditions or trends in the biotechnology and biopharmaceutical industries;

•	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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1)

Term/Termination. From time to time, Customer may submit to WuXi AppTec written work orders (“Work Orders”) for services (“Services”) to be performed by WuXi AppTec under this Agreement. Upon mutual agreement and execution of a Work Order by both Parties, such Work Order shall be incorporated into this Agreement. This Agreement shall become effective as of the Effective Date and will expire on the later of (a) [*] years from the Effective Date or (b) the completion of all Services under the last Work Order executed by the Parties prior to the [*] anniversary of the Effective Date. The Agreement may be extended by mutual agreement of the Parties or earlier terminated in accordance with Section 11.

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

3)

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

4)	Procurement, Processing and Packaging.

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(a)

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

(b)

Customer hereby grants WuXi AppTec the non-exclusive right to use the Starting Material and any Confidential Information (as defined in Section 10) supplied by Customer for the sole purpose of performing the Services for Customer under the Agreement and the relevant Work Order. WuXi AppTec hereby undertakes not to use the Starting Material or any Confidential Information of Customer for any other purpose.

(c)

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

(d)

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

(e)

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

(f)

WuXi AppTec represents and warrants that: (i) the Services will be performed in compliance with the terms and conditions of this Agreement, the applicable Work Order and all applicable laws and regulations (including without limitation cGMP); (ii) the Product delivered will comply with the Product Specifications; (iii) the Services performed by WuXi AppTec hereunder will not infringe or misappropriate any intellectual property rights of any third party. In the event that any Service or

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

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

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

(b)

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

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

(d)

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

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

(f)

Promptly following receipt of Product or any sample thereof, Customer may carry out any of the tests outlined or referred to in the Product Specifications. If such tests show that the Product fails to meet the Product Specifications, Customer shall have the right to reject such Product by giving WuXi AppTec written notice thereof within [*] from [*]. In addition, except where the shelf life of the Product has expired, Customer shall have the right to reject the Product if Customer later discovers any non-obvious defect not reasonably susceptible to discovery within the [*] notice period and provides notice thereof to WuXi AppTec within [*] after [*]. Customer shall return such non-conforming Product

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6)	Consideration.

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

(b)

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

(c)

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

7)	Quality Assurance.

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

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(b)

Each Party will notify the other Party promptly upon receipt of information indicating that any of the Products may be subject to a recall, field corrective action or other regulatory action with respect to a Product taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment (a “Remedial Action”). Customer shall be responsible for determining the necessity of conducting any Remedial Action and WuXi AppTec shall cooperate in gathering and evaluating such information as is reasonably necessary for Customer to make such determination. In the event Customer determines that a Remedial Action should be commenced or a Remedial Action is required by any governmental authority having jurisdiction over the matter, Customer shall be responsible for the control and coordination of all efforts necessary to conduct such Remedial Action and shall keep WuXi AppTec reasonably informed regarding the status of such Remedial Action. [*] shall be responsible for the cost and expense of the Remedial Action unless the Remedial Action results from [*], in which case [*] shall be responsible and shall reimburse [*] for the cost and expense of such Remedial Action.

(c)

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

(a)

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

(b)

WuXi AppTec shall indemnify and hold Customer harmless against all claims, actions, costs, expenses (including, without limitation, court costs and reasonable attorney’s fees) or other liabilities (collectively, “Losses”) whatsoever to, from or in favor of third parties, to the extent such Losses are caused or contributed to by 1) WuXi AppTec’s performance of the Services (except to the extent resulting from WuXi AppTec’s use of [*]); and/or 2) the [*] or breach of this Agreement of WuXi AppTec or any of its employees or agents in the performance of Services. WuXi AppTec’s liability to indemnify Customer shall be reduced to the extent that such Losses were caused or contributed to by the [*] or breach of this Agreement by Customer. In the event a third party claim is asserted against Customer for which indemnification is required hereunder, Customer shall give WuXi AppTec prompt written notice thereof. Customer shall cooperate with WuXi AppTec, at WuXi AppTec’s cost and expense, in the defense of any such claim. WuXi AppTec shall have the sole right to defend and/or settle such a claim, including selecting counsel of its choice. Costs, expenses and fees

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(c)

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

(d)

WuXi AppTec’s sole liability for any loss or damage suffered by Customer as a result of any breach of the Agreement or of any other liability of WuXi AppTec in respect of the Services conducted under this Agreement or any Work Order (including without limitation the production and/or supply of the Product) shall be limited to [*] in an amount not exceed [*]. This limitation shall not apply in the event such damages were caused by the gross negligence or willful misconduct (including, without limitation, intentional breach, non-performance or delay) of WuXi AppTec, or WuXi AppTec’s breach of [*] set forth in Section [*] or its [*] set forth in [*] Section [*].

(e)

Except for losses or damages arising from breach of [*] obligations or from a Party’s gross negligence or willful misconduct (including, without limitation, intentional breach, non-performance or delay), neither Party shall be liable hereunder for any special, indirect, incidental, consequential or punitive damages, even if such Party shall have been advised of the possibility of such potential damages.

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

(a)

While this Agreement is in effect, and for a period of [*] years after the termination of the Agreement, neither Party, nor either Party’s affiliates, or any directors, shareholders, officers, employees or agents of the foregoing (collectively, the “Affiliates”), shall use or divulge to anyone any Confidential Information of the other Party (as hereinafter defined), except: (i) as required in the course of performing the obligations hereunder; (ii) to attorneys, accountants and other advisors; (iii) with the express written consent of the other Party; or (iv) as required by law (provided that such Party shall promptly notify the other Party of such required disclosure and shall reasonably assist such other Party to obtain a protective order limiting or restricting the required disclosure). In addition, Customer shall have the right to disclose and use WuXi AppTec’s Confidential Information to the extent necessary or useful for Customer’s development, commercialization or other exploitation of the Product or other results or deliverables of the Services. The term “Confidential Information” of a Party shall mean any information relating to such Party or its business which is (1) disclosed to the other Party (or to the other Party's Affiliates) during the negotiation of and performance of this Agreement and (2) is marked “Confidential” if provided in writing, or if delivered verbally, is reduced to writing within [*] and marked “Confidential.” In addition, all Data and Inventions (as defined in Section 19(a)) shall be deemed Customer’s Confidential Information. “Confidential Information” shall not include any information which: (i) becomes public knowledge without breach by the other of this Agreement; (ii) is obtained by the other (or the other's Affiliates) from a person or business entity under circumstances permitting its disclosure to others; or (iii) may be demonstrated to have been known at the time of receipt thereof as evidenced by tangible records. If a party makes a disclosure of Confidential Information that is permitted by the terms of this Agreement, such party shall be

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(a)

Customer has the right to terminate this Agreement or any Work Order for any reason or no reason by delivery of written notice of such termination to WuXi AppTec effective [*] following delivery of such notice. In addition, each Party has the right to terminate this Agreement by delivery of written notice of such termination to the other Party effective immediately upon the receipt of such notice, upon the occurrence of any of the following events: (i) In the event that the other Party shall be adjudicated bankrupt or shall petition for or consent to any relief under any bankruptcy, reorganization, receivership, liquidation, compromise, or any moratorium statute, whether now or hereafter in effect, or shall make an assignment for the benefit of its creditors, or shall petition for the appointment of a receiver, liquidator, trustee or custodian is appointed for all or a substantial part of its assets and is not discharged within [*] after the date of such appointment; (ii) Upon the failure of the other Party to remit an undisputed and past due payment required to be remitted under this Agreement within [*] following the receipt of a written notice of such past due payment; (iii) Upon any default in the performance of or breach of any agreement, covenant, obligation or undertaking of the other Party made hereunder (other than a default in payment dealt with under subsection (ii) above) that has not be remedied to the reasonable satisfaction of the terminating Party within [*] following the terminating Party’s delivery of written notice of such default or breach to the other Party; or (iv) Upon a failure or delay of fulfillment of all or part of this Agreement that continues for a period of [*] and results from a “force majeure” event set forth in Section 17 below.

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

12)

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

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

14)

Entire Agreement. This Agreement and any attachments hereto, together with any executed Work Orders and any related quality agreement, constitute the entire understanding of the Parties with respect to the matters contained herein. In case one or more amendments, modifications or alterations of this Agreement become necessary, the Parties shall negotiate in good faith on such amendments, modifications or alterations. This Agreement may be amended, modified or altered only by an instrument in writing duly executed by both Parties.

15)	Force Majeure. The Parties hereto shall not be liable in any manner for the failure or delay of fulfillment of all or part of this Agreement, directly or indirectly, owing to governmental orders or

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16)

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

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

18)	Arbitration

(a)

In the event of any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity thereof, each party shall by written notice to the other have the right to have such dispute referred to the senior management of WuXi AppTec and Customer for attempted resolution by good faith negotiations within [*] after such notice is received. If such senior management is unable to resolve such dispute within such [*] period, either Party may invoke the provisions of Section 18(b). Any settlement reached by the Parties under this Section shall not be binding until reduced to writing and signed by the above-specified management of WuXi AppTec and Customer. When reduced to writing, such agreement shall supersede all other agreements, written or oral, to the extent such agreements specifically pertain to the matters so settled.

(b)

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

(c)

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

19)	Inventions and Technology Transfer.

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

21)	Notices. Any notice or report required or permitted to be given or made under this Agreement by one of the Parties hereto to the other Party shall be in writing and shall be deemed to have been sufficiently given for all purposes, and effective as of the date of receipt, if mailed by certified mail

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

23)

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

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

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1.0	Project Management

1.1	Project Team.

1.2	Project Manager.

1.2.1	Fielding questions and monitoring accurate implementation of instructions.

1.2.2	Interfacing with the project team and all other functions (quality, raw materials testing, logistics control, etc.) to ensure that project timelines and cost objectives are met.

1.2.3	Scheduling resources to provide efficient and rapid transitions throughout the phases of this project.

1.2.4	Coordinating delivery of on-going project tracking reports and summaries in a mutually agreed upon format.

1.2.5	Facilitating team meetings.

1.2.6	Coordinating/finding solutions to project issues in a proactive and timely manner.

1.2.7	Implementing the project communication plan.

1.2.8	Ensuring invoices to Customer are appropriate for work performed.

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2.0	Technology Transfer

2.1	Product and Process Specific Assay Procedures and Data.

2.2	[*] Production Processes and Data.

2.3	Initializing Manufacturing Facilities, [*] Procurement, Qualification and Release for GMP Manufacture.

2.4	Document Preparation.

2.5	Client Visits and Observation

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3.0	Process Development Studies

3.2	Process Optimization / [*]

3.3	Process Development Report

4.0	[*] Manufacture / Characterization

4.1	Batch Record and Documentation Preparation

4.2	Facility / Production Suite Preparation

4.3	[*] Pilot Manufacturing Runs

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4.4	[*] Engineering Runs

4.5	Media Challenges

4.6	Conformance Lots

4.7	Vialing, Labeling, of [*]

4.8	Lot-Release Testing

4.9	[*] Storage

4.10	Testing and Characterization

4.11	Validation Summary Reports

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5.0	Analytical Method Transfer

5.1

The characterization and safety tests are outlined in the Testing Section. All of the routine assays for the assessment of the [*] are available or can be developed in the Process Development and Testing departments. WuXi AppTec has well-established testing programs with batch records spanning technical areas such as virus detection, analytical analysis, DNA analysis and characterization; residual analysis, potency assays, cell viability, flow cytometry, and other standard cell biology methods. Batch records are in place for these assays and a custom assay program is available for rapid assay transfer, development, qualification, and document preparation.

5.2

For assay transfer, initial work will involve discussion with NewLink Genetics and transfer of any existing technology as documents or expertise. NewLink Genetics personnel may assist and visit WuXi AppTec to share technical details. Based on the assay-specific technology transfer documents, protocols will be written by WuXi AppTec personnel following document-specific SOPs. Documents will be circulated for review and approval, with final approval by the Production Manager or Study Director and the Quality Assurance department. If a batch record is already in place for a given assay, then WuXi AppTec and NewLink Genetics may jointly decide that the assay may be verified for use with NewLink Genetics’ specific product or process intermediate. This will be done by assaying that material (using the existing batch record) to determine any interference or other influence the material may have on the assay.

5.3

Compendia methods, by definition will be run cGMP. Other analytical or QC methods required to be performed cGMP need to be validated to the level appropriate for the stage of product development. In this instance, acceptance criteria for the assay would be established during assay development. These will be included in a validation protocol that will analyze required components of assay validation, based on ICH or USP guidelines and following WuXi AppTec’s internal validation program. [*].

6.0	Chemistry, Manufacturing and Controls Documentation

6.1	CMC Section Documentation

6.1.1	Description of the Manufacturer’s organization, including facility and the general activities and types of products supported in the facility.

6.1.2	Data from the testing of NEWLINK GENETICS [*].

6.1.3	A description and flow chart of the process steps used in the production of the [*].

6.1.4	Tables listing the types, grades and sources of the [*].

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•	[*]

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•	[*]

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1.	Invoicing will be as follows:

•	[*] for [*] (excluding the following) upon [*], and [*] at [*].

a.	[*] will be invoiced [*] upon [*]

b.	[*] will be invoiced monthly

c.	[*] will be invoiced [*] upon [*] and [*] at [*].

•	[*] charged at [*] will be invoiced at least monthly for [*] at the time of [*]. [*] not charged at [*] will be invoiced [*] upon [*] and [*] at [*]. [*].

•	[*] of [*] and [*] will be invoiced [*] upon [*] and [*] at [*].

•	[*] and [*] will be invoiced [*] upon [*] and [*] upon [*]. The remaining [*] will be invoiced upon [*] of the [*] or [*] after [*] whichever is sooner.

•	[*] of [*] and [*] will be invoiced upon [*].

•	[*] will be invoiced [*] upon [*] and [*] upon [*].

•	[*] will be billed at [*] of the [*] at the [*].

2.	All [*], and all other [*] and [*] purchased by WuXi AppTec ([*] will be asked to [*] and [*] in a [*] prior to purchase) will be invoiced upon [*] at [*]. [*], and all other [*] and [*] will be invoiced [*]. [*] and other [*] will be [*] upon [*] and [*]. Terms are [*]. Invoices are “billed and payable” in [*].

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1.	GENERAL.

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Vesting Schedule:	The shares subject to the Award shall vest as follows: 100% of the shares will vest on the earlier of (i) the first anniversary of the date of grant and (ii) the date of the first Annual Meeting following the date of grant, subject to the Participant’s Continuous Service on each applicable vesting date.

Issuance Schedule:	Subject to any change on a Capitalization Adjustment, one share of Common Stock will be issued for each Restricted Stock Unit that vests at the time set forth in Section 6 of the Award Agreement.

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ATTACHMENTS:	Award Agreement and 2010 Non-Employee Director Stock Award Plan, as amended

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Vesting Schedule:	The shares subject to the Award shall vest as follows: 25% of the shares will vest on each of the first, second, third and fourth annual anniversaries of the Vesting Commencement Date, subject to the Participant’s Continuous Service on each applicable vesting date.

Issuance Schedule:	Subject to any change on a Capitalization Adjustment, one share of Common Stock will be issued for each Restricted Stock Unit that vests at the time set forth in Section 6 of the Award Agreement.

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ATTACHMENTS:	Award Agreement and 2009 Equity Incentive Plan, as amended

Vesting Schedule:	The shares subject to the Award shall be fully vested upon issuance.

Issuance Schedule:	Subject to any change on a Capitalization Adjustment, one share of Common Stock will be issued for each Restricted Stock Unit that vests at the time set forth in Section 6 of the Award Agreement.

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ATTACHMENTS:	Award Agreement and 2009 Equity Incentive Plan, as amended

1.	I have reviewed this quarterly report on Form 10-Q 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 quarterly report on Form 10-Q 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.	The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 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.