Nabriva Therapeutics plc (Form: 8-K, Received: 07/25/2018 06:13:44)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): July 23, 2018

NABRIVA THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

Ireland		001-37558		Not Applicable
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

25-28 North Wall Quay, IFSC, Dublin 1, Ireland		Not Applicable
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code (610) 816-6640

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

Item 1.01. Entry into a Material Definitive Agreement.

On July 23, 2018, Nabriva Therapeutics plc (the “Company”) and its newly formed, direct wholly owned subsidiaries, Zuperbug Merger Sub I, Inc. (“Merger Sub I”) and Zuperbug Merger Sub II, Inc. (“Merger Sub II”, and together with Merger Sub I, “Merger Subs”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Zavante Therapeutics, Inc. (“Zavante”) and Cam Gallagher, solely in his capacity as representative of the former Zavante stockholders in connection with the Merger Agreement, pursuant to which on July 24, 2018, Merger Sub I merged with and into Zavante with Zavante surviving such merger and becoming a wholly owned subsidiary of the Company, and Zavante thereafter on such date merged with and into Merger Sub II, with Merger Sub II surviving the merger as a wholly owned subsidiary of the Company and assuming the name Zavante Therapeutics, Inc. (collectively, the “Acquisition”). Zavante is a biopharmaceutical company focused on developing CONTEPO (fosfomycin for injection) to improve the outcomes of hospitalized patients.

The Acquisition was completed on July 24, 2018. Upon completion of the Acquisition (the “Closing”), the Company issued 7,336,906 Company ordinary shares to former Zavante stockholders, which together with the 815,186 ordinary shares that are issuable upon release of the Holdback Shares (as defined below) constitute approximately 19.9% of the Company ordinary shares outstanding as of immediately prior to the Closing (the “Upfront Shares”).

Pursuant to the Merger Agreement, former Zavante stockholders and other equity holders, in the aggregate and subject to the terms and conditions of the Merger Agreement, will also be entitled to receive from the Company up to $97.5 million in contingent consideration, of which $25.0 million would become payable upon the first approval of a new drug application from the U.S. Food and Drug Administration (the “FDA”) for fosfomycin for injection for any indication (the “Approval Milestone Payment”) and an aggregate of up to $72.5 million would become payable upon the achievement of specified sales milestones (the “Net Sales Milestone Payments”).

Subject to approval of the Company’s shareholders of the issuance of Company ordinary shares in satisfaction of the Company’s milestone payment obligations in accordance with Nasdaq listing rules and Irish law (the “Milestone Share Approval”) in excess of 19.9% of the issued and outstanding ordinary shares of the Company outstanding as of immediately prior to the Closing, the Approval Milestone Payment will be settled in Company ordinary shares and the Company will have the right to settle the Net Sales Milestone Payments in Company ordinary shares, except as otherwise provided in the Merger Agreement. In the absence of obtaining the Milestone Share Approval, all milestone payments will be settled in cash. The Company has agreed to use commercially reasonable efforts after the Closing to obtain the Milestone Share Approval and to call a meeting of Company shareholders no later than December 31, 2018 to seek the Milestone Share Approval.

In connection with the Acquisition, former Zavante stockholders agreed to cause any Upfront Shares received by them to abstain from voting on the Milestone Share Approval and to vote any other Company ordinary shares held by them in favor of the Milestone Share Approval.

Subject to the terms of the Merger Agreement, 10% of the Upfront Shares (the “Holdback Shares”) will serve as a source for the satisfaction of indemnification and other obligations of the former Zavante stockholders and, subject to reduction in respect of these obligations, will be issued to the former Zavante stockholders following the first anniversary of the Closing.

The Upfront Shares issued at Closing were, and the Holdback Shares and any other Company ordinary shares that may become issuable in the future under the Merger Agreement will be, issued in reliance on the exemption from registration provided under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and/or Regulation D thereunder. The Company agreed in the Merger Agreement to provide registration rights with respect to the registration for resale of any Company ordinary shares that may be issued in satisfaction of the Company’s milestone payment obligations under the Merger Agreement. Former Zavante stockholders who do not comply with specified procedural requirements set forth in the Merger Agreement, and former holders of Zavante options and warrants, will receive cash in lieu of any Company ordinary shares that otherwise would be issuable to them pursuant to the Merger Agreement.

In connection with the Closing, Mr. Theodore Schroeder, former president, chief executive officer and director of Zavante, was appointed as the chief executive officer of the Company and certain of the Company’s

subsidiaries and Dr. Colin Broom resigned from his position of chief executive officer of the Company and certain of the Company’s subsidiaries. Dr. Broom will continue to serve on the Company’s board of directors (the “Board”) and as a consultant. The Schroeder Agreement (defined below) provides that Mr. Schroeder will be appointed to the Company’s Board effective upon the later of the Closing and immediately following the Company’s 2018 Annual General Meeting of Shareholders, scheduled to be held on August 1, 2018.

The parties made customary representations and warranties in the Merger Agreement. The survival of the parties’ respective representations and warranties generally is limited to 12 months following the Closing, subject to specified exceptions, including in the case of “fundamental representations”, which survive for six years. The Company and the former Zavante stockholders have agreed to indemnify each other for specified matters, including breaches of representations, warranties and covenants, as well as, in the case of the former Zavante stockholders, specified taxes, excess transaction expenses, material misrepresentations in or omissions from any registration statement pursuant to which the Company ordinary shares issued in satisfaction of the Company’s milestone payment obligations are registered for resale and other liabilities. The indemnification obligations of the former Zavante stockholders are limited to the Holdback Shares and, under certain circumstances, may be offset against milestone payments that become due and payable under the Merger Agreement. In certain situations, the Company will not be entitled to any indemnification unless the aggregate amount of losses incurred by the Company exceeds the product of 0.75%, the Upfront Shares and the volume-weighted average price of a Company ordinary share over the 20-day period ending three days prior to Closing. The indemnification obligations of the Company are limited to the cash value of the Holdback Shares or, under certain circumstances, the total amount of consideration in the Acquisition.

The forgoing summary of terms of the Merger Agreement is qualified in its entirety by reference to the Merger Agreement, which is attached to this Current Report on Form 8-K as Exhibit 2.1 and is incorporated herein by reference.

The Merger Agreement has been filed as an exhibit to this Current Report on Form 8-K in accordance with rules and regulations of the U.S. Securities and Exchange Commission to provide investors with information regarding its terms. It is not intended to provide any other factual information about the Company or Zavante. The representations, warranties and covenants contained in the Merger Agreement were made only for purposes of the Merger Agreement as of the specific dates therein, were solely for the benefit of the parties to the Merger Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures made for the purposes of allocating contractual risk between the parties to the Merger Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the Merger Agreement and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the parties thereto or any of their respective subsidiaries or affiliates. Moreover, information concerning the subject matter of representations and warranties may change after the date of the Merger Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures.

Item 2.01. Completion of Acquisition or Disposition of Assets.

The information set forth in Item 1.01 regarding the Acquisition and the information set forth in Item 5.02 regarding Mr. Schroeder is incorporated by reference into this Item 2.01.

In connection with the Closing, the Company acquired certain agreements to which Zavante is a party, including the Stock Purchase Agreement, the Sorrento Lease, the Three-Way Agreement, the Ercros Supply Agreement, the ERN Supply Agreement, the Fisiopharma Supply Agreement and the Packaging Agreement (each as defined in Item 8.01). The descriptions of these agreements set forth in Item 8.01 are incorporated herein by reference.

Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The description of the Sorrento Lease set forth in Item 8.01 is incorporated by reference into this Item 2.03.

Item 3.02. Unregistered Sales of Equity Securities.

The description of the ordinary shares consideration under the terms of the Merger Agreement set forth in Item 1.01 is incorporated herein by reference. In connection with the Closing of the Acquisition, the Company issued to stockholders of Zavante the ordinary shares consideration pursuant to an exemption from registration afforded by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Resignation of Colin Broom, M.D., Chief Executive Officer

In connection with the signing of the Merger Agreement, on July 23, 2018, Nabriva Therapeutics US, Inc. (“Nabriva US), a wholly owned subsidiary of the Company, entered into a Transition, Separation and Release of Claims Agreement (the “Transition Agreement”) with Colin Broom, M.D., chief executive officer of the Company and Nabriva US and their affiliates, as applicable, providing for Dr. Broom’s separation from employment with Nabriva US and resignation from the offices of chief executive officer of the Company and Nabriva US, contingent on and effective as of the Closing of the Acquisition (the “Transition Date”). Pursuant to the terms of the Transition Agreement, Nabriva US and Dr. Broom also entered into a Consulting Agreement (the “Consulting Agreement”) effective July 24, 2018, pursuant to which Dr. Broom will provide to Nabriva US, upon the request of the Board, consulting and advisory services relating to the preparation and submission of a new drug application for the Company’s lefamulin product candidate to the FDA (collectively, the “Services”). Dr. Broom will continue to serve as a director on the Board following the Transition Date.

Transition Agreement

Pursuant to the Transition Agreement, during the period between the execution of the Transition Agreement and the Transition Date, Dr. Broom remained chief executive officer of the Company and Nabriva US. For so long as Dr. Broom serves as a non-employee director on the Board, he will be entitled to compensation for such services consistent with the Company’s Non-Employee Director Compensation Policy as in effect from time to time (the “Policy”). However, Dr. Broom will not be eligible to receive an “initial grant” of share options under such Policy or an “annual grant” of share options under such Policy in 2018.

Pursuant to the Transition Agreement, in return for Dr. Broom’s execution of the Transition Agreement and timely execution and nonrevocation of an additional release of claims at the time of the Transition Date, Dr. Broom is being provided the “severance benefits” described in his amended and restated employment agreement dated as of June 17, 2016 (the “Employment Agreement”) that he would be entitled to receive upon a “qualifying termination” occurring prior to or more than 12 months following a “change in control” (as such terms are defined in the Employment Agreement). Specifically, he will be entitled to receive continued payment of his current annual base salary of $471,534 for a period of 18 months, or $707,301 in the aggregate; subject to certain conditions, payment by Nabriva US of a portion of health coverage premiums for a period of up to 18 months following the Transition Date; and a lump sum payment of $132,417 which is equal to the prorated portion of Dr. Broom’s 2018 annual target bonus of $235,767, representing 50.0% of his 2018 annual base salary, based on the number of days of his employment by Nabriva US in 2018.

In addition, pursuant to the Transition Agreement, Dr. Broom will continue to vest in any options he holds to purchase the Company’s ordinary shares that were outstanding as of the Transition Date (the “Outstanding Options”) for a period of 12 months following the Transition Date provided he remains on the Board during such 12-month period. In the event his service as a director on the Board terminates before the 12-month anniversary of

the Transition Date, the portion of the Outstanding Options that would have vested had Dr. Broom remained on the Board through the 12-month anniversary of the Transition Date will be accelerated at that time. Any of Dr. Broom’s options that are unvested at the 12-month anniversary of the Transition Date will terminate and Dr. Broom will no longer have any rights with respect to them. In addition, the post-termination exercise period of the vested Outstanding Options will be extended such that Dr. Broom is entitled to exercise any vested Outstanding Options until the later of the date that is 24 months following the Transition Date and the date that is three months following his cessation of service on the Board (but in no event later than the final exercise date applicable to such option). The Transition Agreement also provides that, if Dr. Broom continues to serve on the Board or to provide Services under the Consulting Agreement on the effective date of grant, he shall continue to be entitled to receive the grant of performance-based restricted share units (the “Broom PRSUs”) previously approved by the Board, which will vest in accordance with, and otherwise be subject to the terms and conditions of, the previously-approved award agreement. However, if Dr. Broom ceases to serve on the Board and ceases to provide Services under the Consulting Agreement following achievement of the applicable performance metric under the Broom PRSUs but before the first anniversary of the achievement of the performance vesting metric, the award will accelerate and vest in full at the time he ceases to provide all services on the Board and as a consultant.

The Transition Agreement also provides for, among other things, a release of claims by Dr. Broom in favor of Nabriva US and its affiliates, continuing confidentiality, non-solicitation and non-competition obligations applicable to Dr. Broom under his existing Proprietary Rights, Non-Disclosure and Developments Agreement with Nabriva US, and a mutual non-disparagement obligation applicable to Nabriva U.S. and Dr. Broom.

Consulting Agreement

Pursuant to the Consulting Agreement, Nabriva US and Dr. Broom agreed that Dr. Broom will receive $500.00 per hour in consulting fees for his performance of the Services under the Consulting Agreement. The term of the Consulting Agreement will be from the Transition Date until January 31, 2020, and may be extended for additional periods upon mutual written agreement of both Nabriva US and Dr. Broom. In addition, the Consulting Agreement may be terminated by Nabriva US if Dr. Broom materially breaches the Consulting Agreement or the Transition Agreement or if Dr. Broom fails to sign or revokes the additional release of claims in our favor at the time of the Transition Date; by Dr. Broom, if Nabriva US materially breaches the Consulting Agreement or the Transition Agreement; at any time by either Nabriva US or Dr. Broom upon not less than 15 days prior written notice to the other party; at any time upon the mutual written consent of the parties; or automatically upon the death, physical incapacitation or mental incompetence of Dr. Broom.

Appointment of Theodore Schroeder as Chief Executive Officer

In connection with the signing of the Merger Agreement, on July 23, 2018, Nabriva US entered into an Employment Agreement with Theodore Schroeder (the “Schroeder Agreement”) providing for Mr. Schroeder, age 63, to serve as chief executive officer of the Company and president and chief executive officer of Nabriva US, contingent on and effective as of the Closing of the Acquisition (the “Commencement Date”).

Prior to the Closing, Mr. Schroeder served as president, chief executive officer and director of Zavante. Previously, Mr. Schroeder co-founded Cadence Pharmaceuticals in 2004 and served as president, chief executive officer and a member of the board of directors until the company’s acquisition by Mallinckrodt Pharmaceuticals in 2014. Prior to that, he held several roles at Elan Pharmaceuticals, including senior vice president of North American sales and marketing, and vice president and general manager of the hospital products business unit, a role he also held at Dura Pharmaceuticals before its acquisition by Elan Pharmaceuticals. Earlier in his career, Schroeder held a number of hospital-related sales and marketing positions with Bristol-Myers Squibb. He currently serves on the public company board of directors of Cidara Therapeutics, Otonomy and Collegium Pharmaceutical. In addition, he previously served on the board of directors of Hyperion Therapeutics, Incline Therapeutics and Trius Therapeutics until their respective acquisitions. Mr. Schroeder is a former chair of BIOCOM, the Southern California life sciences trade association. Mr. Schroeder received a bachelor’s degree in management from Rutgers University.

As a stockholder of Zavante, Mr. Schroeder received 0.8% of Company ordinary shares issued to former Zavante stockholders as consideration in connection with the closing of the Acquisition and will be entitled to receive his proportional share of any Company ordinary shares or cash paid in satisfaction of the Company’s milestone payment

obligations and upon the release by the Company, if any, of the Holdback Shares on the terms and subject to the conditions set forth in the Merger Agreement. In addition, Mr. Schroeder will be entitled to registration rights with respect to the registration with the SEC for resale of any Company ordinary shares that may be issued in satisfaction of the Company’s milestone payment obligations pursuant to the Merger Agreement.

Mr. Schroeder has no family relationship with any of the executive officers or directors of the Company and there are no arrangements or understandings between Mr. Schroeder and any other person pursuant to which he is being appointed as the chief executive officer of the Company or will be appointed as a director of the Company, other than as disclosed in this Current Report on Form 8-K.

Schroeder Agreement

Pursuant to the Schroeder Agreement, Mr. Schroeder will receive an annual base salary of $530,000 and be eligible to receive an annual performance bonus targeted at 50% of his annual base salary, with the actual amount of such bonus, if any, to be determined by the Board. For 2018, Mr. Schroeder’s bonus will be pro-rated to reflect his 2018 service to Nabriva US. Mr. Schroeder will also be entitled to participate in the Company’s employee benefit plans, subject to the terms and conditions of such plans.

Pursuant to the Schroeder Agreement, the Board also approved the grant to Mr. Schroeder, effective as of the first business day immediately following the Commencement Date (the “Grant Date”), of a non-statutory stock option to purchase 850,000 ordinary shares of the Company at an exercise price per share equal to the closing price per share of the Company’s ordinary shares on the Nasdaq Global Select Market on the Grant Date. The option award will have a ten-year term and will vest over a four-year period, with 25% of the shares underlying the award vesting on the first anniversary of the Commencement Date and the remaining 75% of the shares underlying the option award to vest monthly over the subsequent 36-month period. In addition, the Board approved the grant to Mr. Schroeder, effective as of the Grant Date, of 150,000 performance-based restricted share units (the “Schroeder PRSUs”). The Schroeder PRSUs will vest as follows: 50% of the Schroeder PRSUs will vest upon Board certification of the receipt of FDA approval of a new drug application for each of (x) lefamulin and (y) CONTEPO for any indication, and 50% of the Schroeder PRSUs will vest on the first anniversary of such Board certification, provided, in each case, that Mr. Schroeder is performing services to Nabriva US on the applicable vesting dates. If the FDA does not approve an NDA for both lefamulin and CONTEPO by January 31, 2020, the Schroeder PRSUs award will terminate in full. The option being granted to Mr. Schroeder and the Schroeder PRSUs will be awarded outside of the Company’s 2017 Share Incentive Plan as an inducement material to Mr. Schroeder’s entering into employment with Nabriva US in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4).

In the event of the termination of Mr. Schroeder’s employment by Nabriva US without cause or by him for good reason prior to, or more than 12 months following, a “change in control” (as defined in the Schroeder Agreement), Mr. Schroeder will be entitled to his base salary that has accrued and to which he is entitled as of the termination date. In addition, subject to execution and nonrevocation of a release of claims in favor of Nabriva US and its affiliates by him or his estate, as applicable, and his continued compliance with his proprietary rights, non-disclosure, developments and non-solicitation agreement with Nabriva US, he will be entitled to continued payment of his base salary for a period of 18 months following termination; subject to certain conditions, payment by Nabriva US of a portion of health coverage premiums for a period of up to 18 months following termination; a lump sum payment equal to any earned but unpaid annual bonus for a previously completed calendar year; a lump sum payment equal to a prorated annual bonus for the year in which Mr. Schroeder’s employment is terminated based on the number of days he was employed by Nabriva US during the year; and all of his then-outstanding equity awards that vest based solely on the passage of time (including performance-based awards that are subject to time-based vesting following achievement of the applicable performance metric, provided the performance metric has been achieved at the time of termination) shall accelerate with respect to the portion of the award that would have vested in the 12-month period following the termination date.

In the event of the termination of Mr. Schroeder’s employment by Nabriva US without cause or by him for good reason within 12 months following a change in control, subject (as described above with respect to certain payments), to his execution and nonrevocation of a release of claims in favor of Nabriva US and its affiliates and his

continued compliance with his proprietary rights, non-disclosure, developments and non-solicitation agreement with Nabriva US, Mr. Schroeder would be entitled to the same payments and benefits as described in the preceding paragraph, except that, in lieu of a pro-rated annual bonus payment, he would be entitled to receive a lump sum payment equal to 100% of his target bonus for the year in which his employment is terminated and in lieu of 12 months’- vesting acceleration, he would be entitled to full vesting acceleration of his then-unvested equity awards such that his equity awards become fully exercisable and non-forfeitable as of the termination date.

If Mr. Schroeder’s employment is terminated for any other reason, including as a result of his death or disability, for cause, or voluntarily by Mr. Schroeder without good reason, Nabriva US’s obligations under the employment agreement cease immediately, and Mr. Schroeder is only entitled to his base salary that has accrued and to which he is entitled as of the termination date. If, however, his employment is terminated as a result of his death or disability, subject to his execution and nonrevocation of a release of claims in favor of Nabriva US and its affiliates and his continued compliance with his proprietary rights, non-disclosure, developments and non-solicitation agreement with Nabriva US, he or his estate, as applicable, would be entitled to any earned but unpaid annual bonus from a previously completed calendar year.

The Schroeder Agreement also obligates Mr. Schroeder to comply with certain invention, confidentiality, and non-solicitation provisions pursuant to a proprietary rights, non-disclosure, developments and non-solicitation agreement with Nabriva US. In connection with his appointment, Mr. Schroeder also entered into the Company’s standard form of indemnification agreement applicable to executive officers and directors of the Company.

The Schroeder Agreement provides that Mr. Schroeder will be appointed to the Company’s Board effective upon the later of the Closing and immediately following the Company’s 2018 Annual General Meeting of Shareholders, scheduled to be held on August 1, 2018. Pursuant to the Schroeder Agreement, Mr. Schroeder was also appointed to the board of directors of Nabriva US and Nabriva Therapeutics Ireland DAC effective as of July 24, 2018 (the Commencement Date). As an employee of Nabriva US, Mr. Schroeder will not receive any additional compensation for his service as a director of these entities.

The foregoing descriptions of the Transition Agreement, the Consulting Agreement and the Schroeder Agreement are qualified in their entirety by reference to the full text of the Transition Agreement, the Consulting Agreement and the Schroeder Agreement, which are attached hereto as Exhibits 10.1, 10.2 and 10.3, respectively, and are incorporated herein by reference. In addition, the description of the Merger Agreement is incorporated by reference into this Item 5.02.

Promotion of Steven Gelone to President and Chief Operating Officer

Effective as of July 24, 2018, Steven Gelone, age 50, was promoted to president and chief operating officer of the Company. Prior to this promotion, Dr. Gelone served as the chief scientific officer of the Company since June 30, 2017. Dr. Gelone previously served as Nabriva Therapeutics AG’s chief development officer and head of business development from 2014 until the Company’s redomiciliation and the Company’s chief development officer from the Company’s redomiciliation until June 30, 2017. Prior to joining Nabriva Therapeutics AG, he served as head of clinical research and development at Spark Therapeutics, Inc. in 2014 and vice president of clinical and preclinical development at ViroPharma Incorporated from 2005 to 2014. Dr. Gelone also served as director of medical affairs at Vicuron Pharmaceuticals from 2002 to 2003 and director of clinical pharmacology and experimental medicine at GlaxoSmithKline Pharmaceuticals from 2000 to 2002. Dr. Gelone received his B.S. Pharm. and Pharm.D. from Temple University.

In connection with his promotion to president and chief operating officer of the Company, Dr. Gelone’s annual base salary was increased to $450,000 from $409,500 and his annual target bonus percentage was increased to 45% from 35%. In addition, if Dr. Gelone becomes entitled to severance benefits or change in control severance benefits under his amended and restated employment agreement with Nabriva US (the “Gelone Agreement”), as those terms are defined in the Gelone Agreement, he shall be entitled to receive continued payment of his base salary for a period of 15 months following termination (increased from 12 months) and, subject to certain conditions, payment by Nabriva US of a portion of health coverage premiums for a period of up to 15 months following termination (increased from 12 months), in all events subject to the terms and conditions of the Gelone Agreement. The Board also approved the grant to Dr. Gelone, effective as of the day immediately following the Closing, of an option to purchase 77,500 ordinary shares of the Company at an exercise price per share equal to the closing price per share of the Company’s ordinary shares on the Nasdaq Global Select Market on such effective date of grant (the “Initial Options”) and, effective as of the first business day following the 2018 Annual General Meeting of Shareholders, of an option to purchase 7,500 ordinary shares of the Company at an exercise price per share equal to the closing price per share of the Company’s ordinary shares on the Nasdaq Global Select Market on such effective date of grant (the “Additional Options”) and 32,000 performance-based restricted share units (the “Gelone PRSUs”). The grant of the Additional Options and the Gelone PRSUs is subject to shareholder approval of an amendment to the Company’s 2017 Share Incentive Plan at the Company’s 2018 Annual General Meeting of Shareholders. The Initial Options, the Additional Options and the Gelone PRSUs will be granted to Dr. Gelone under the Company’s 2017 Share Incentive Plan.

The option awards will have a ten-year term and will vest over a four-year period, with 25% of the shares underlying the awards to vest on the first anniversary of the Closing and 75% of the shares underlying the option awards to vest monthly over the subsequent 36-month period. The Gelone PRSUs will vest as follows: 50% of the Gelone PRSUs will vest upon Board certification of the receipt of FDA approval of an NDA for lefamulin, and the remaining 50% of the Gelone PRSUs will vest on the first anniversary of such Board certification, provided, in each case, that Dr. Gelone is performing services to the Company on the applicable vesting dates. If the FDA does not approve an NDA for lefamulin by January 31, 2020, the Gelone PRSUs award will terminate in full.

Dr. Gelone has no family relationship with any of the executive officers or directors of the Company and there are no arrangements or understandings between Dr. Gelone and any other person pursuant to which he is being promoted to president and chief operating officer of the Company, other than as disclosed in this Current Report on Form 8-K or the proxy statement relating to the Company’s 2018 Annual General Meeting of Shareholders.

Item 8.01. Other Information.

The Company is filing as Exhibit 99.1 hereto risk factors related to the Company’s business after giving effect to the Acquisition. In addition, the Company is providing the below description of CONTEPO and the acquired Zavante business.

Description of CONTEPO™ and Zavante Acquired Business

Overview

CONTEPO™ (fosfomycin for injection) is a potentially first-in-class epoxide intravenous (“IV”) antibiotic in the United States with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against many contemporary multi-drug resistant (“MDR”) strains that threaten hospitalized patients. IV fosfomycin has an extensive commercial history in markets outside the United States, where it has been used broadly for over 45 years to treat a variety of indications, including complicated urinary tract infections, bacteremia, pneumonia and skin infections.

CONTEPO inhibits the bacteria’s ability to form a cell wall, which is critical for the cell’s survival and growth. It works at an earlier and different stage of cell wall synthesis than other injectable antibiotics, differentiating its mechanism of action from approved injectable antibiotics. CONTEPO utilizes a dosing approach developed by Zavante for the United States that is designed to optimize the product candidate’s pharmacokinetics and pharmacodynamics in order to improve treatment outcomes.

The CONTEPO development program has focused on obtaining marketing approval in the United States for the treatment of complicated urinary tract infections (“cUTI”), including acute pyelonephritis (“AP”). In April 2017, Zavante announced the results of its pivotal ZTI-01 Efficacy and Safety Study (the “ZEUS Study”), in which CONTEPO met the primary endpoint of statistical non-inferiority versus piperacillin/tazobactam (“PIP-TAZ”). Zavante then met with the FDA in the second half of 2017 to discuss the filing of a new drug application (“NDA”) for CONTEPO. We expect to submit an NDA for CONTEPO, utilizing the FDA’s 505(b)(2) pathway, in the fourth quarter of 2018.

We believe that the ZEUS Study results, along with extensive clinical experience with IV fosfomycin for over 45 years outside the United States, support CONTEPO as a potential first-line treatment for cUTI suspected to be caused by MDR pathogens in the United States. A number of studies report that at least 20% of cUTIs are caused by MDR bacteria and limited treatment options are available in the United States. In addition, non-clinical data have shown that CONTEPO acts in combination with certain other antibiotics to improve bacterial killing.

The FDA has designated CONTEPO as a qualified infectious disease product (“QIDP”) and granted fast track designations to CONTEPO under the Generating Antibiotics Incentives Now (“GAIN”) Act for:

· Complicated urinary tract infections (cUTI)

· Complicated intra-abdominal infections (cIAI)

· Hospital-acquired bacterial pneumonia (HABP)

· Ventilator-associated bacterial pneumonia (VABP)

· Acute bacterial skin and skin structure infections (ABSSSI)

Although we have no current plans to finance development of CONTEPO for indications other than cUTI, including AP, these designations make CONTEPO eligible for Fast Track and GAIN incentives. We may in the future consider additional non-dilutive financing options to advance these programs in the clinic.

cUTIs

Market Overview

Infections due to a bacterial pathogen that is resistant to three or more antibiotic classes have become increasingly common and present a risk to our ability to fight infectious diseases and manage complications in vulnerable patients. According to the United States Centers for Disease Control and Prevention (the “CDC”), more than two million hospital infections caused by bacteria resistant to one or more antibiotics occur every year in the United States, and over 23,000 patients with an antibiotic-resistant pathogen die each year.

The prevalence of antibiotic-resistant bacteria is increasing and is considered a significant threat to global health. In particular, the CDC and the World Health Organization consider antibiotic resistance to be an urgent and critical threat to human health. The prevalence of β-lactamase enzymes among Gram-negative pathogens threatens the usefulness of many β-lactam antibiotics and has resulted in greater reliance on last line antibiotics, including carbapenems.

Urinary tract infections (“UTIs”), including AP, are among the most common infections due to MDR bacteria, including carbapenem-resistant Enterobacteriaceae (“CRE”), and are often healthcare-associated. Global mortality attributable to CRE infections has been estimated in some studies to be over 20% and reflects the need for safe, alternative, carbapenem-sparing agents.

Surveillance and epidemiological studies suggest that some traditional, first-line antibiotics may no longer be acceptable choices for early therapy. In one large-scale surveillance study, approximately one out of three patients hospitalized in the United States with cUTI, a complicated intra-abdominal infection, hospital-associated pneumonia, or a bloodstream infection did not receive timely effective antibiotic therapy, and this delay was associated with increased morbidity and mortality. The rate of antibiotic resistance appears to be two to four times higher in patients who were admitted to the hospital from a nursing home or were recently hospitalized. Antibiotic therapy within the past six months has also been identified as a risk factor for antibiotic resistance.

New classes of antibiotics that are effective against drug-resistant pathogens are needed for early, appropriate treatment of serious infections in hospitalized patients and to treat patients who have failed to respond to standard, first-line antibiotics due to acquired drug resistance.

For over 45 years, oral and IV formulations of fosfomycin have been used in the European Union, Africa, Asia, and South America, and an oral formulation of fosfomycin has been used in the United States and Canada for the treatment of a variety of indications. Oral fosfomycin is available in the United States as single-dose therapy for cystitis and is noted as an appropriate treatment option for cystitis in treatment guidelines by the Infectious Diseases Society of America and the CDC. However, oral administration of fosfomycin provides inadequate concentrations required

for treatment of more serious infections due to its limited bioavailability and dose-limiting gastrointestinal tolerability.

Outside of the United States, IV fosfomycin is approved for patients with a variety of infections, often severe, including cUTI, bacteremia, osteomyelitis, nosocomial lower respiratory tract infections, surgical site infections, bone and joint infections, endocarditis, skin infections and bacterial meningitis. The efficacy and safety profile of IV fosfomycin has been established by more than 45 years of clinical use outside of the United States and has been evaluated in more than 60 clinical studies. Fosfomycin has retained high in vitro activity with a low and stable resistance profile, and continues to be suitable for use as a monotherapy for cUTI despite long term use.

Causes of cUTIs

cUTI is defined as a clinical syndrome characterized by pyuria and a documented microbial pathogen on culture of urine or blood, accompanied by local and systemic signs and symptoms, including fever, chills, malaise, flank pain, back pain or costo-vertebral angle pain or tenderness that occur in the presence of a functional or anatomical abnormality of the urinary tract, or in the presence of catheterization. Indwelling urethral catheters account for 70% to 80% of cUTIs, or 1 million cases per year in the United States. Catheter-associated UTI is the most common cause of secondary bloodstream infections and is linked to increased morbidity and mortality. Patients with pyelonephritis, regardless of underlying abnormalities of the urinary tract, are considered a subset of patients with cUTI.

cUTI is usually caused by a greater variety of pathogens, with a greater likelihood of associated antimicrobial resistance, than uncomplicated UTI (“uUTI”). Escherichia coli (“E. coli”) is isolated in approximately 75% to 95% of uUTIs and approximately 50% of cUTIs and is the most common etiologic agent of cUTIs. Additional commonly-identified Gram-negative uropathogens include other Enterobacteriaceae (such as Klebsiella spp., Proteus spp., Enterobacter cloacae) and non-fermenting Gram-negative bacilli (such as Pseudomonas aeruginosa (“P. aeruginosa”) and Acinetobacter spp.). Gram-positive organisms, such as Enterococci and coagulase-negative Staphylococci, may also be contributing pathogens.

Limitations of Currently Available Treatment Options

We believe bacterial resistance against antimicrobials has created the need for more antibiotic treatment options, particularly among MDR, Gram-negative bacilli (including CRE, extended-spectrum β-lactamase (“ESBL”) producers, and MDR P. aeruginosa). Gram-negative antimicrobial resistance is particularly common among urinary tract pathogens. Enterobacteriaceae, including E. coli and Klebsiella pneumoniae (“K. pneumoniae”), may acquire plasmids that encode ESBLs and confer resistance to third-generation cephalosporins and other broad-spectrum antibiotics. Third-generation cephalosporins and β-lactamase inhibitors (“BLIs”) are also commonly ineffective against Enterobacteriaceae that generate AmpC enzymes.

The recent spread into hospitals of Enterobacteriaceae expressing emergent β-lactamases, including members of the serine carbapenemases and metallo-β-lactamases, endanger antibiotic

options. The lack of available and effective antibiotic classes for these organisms has created an unmet medical need. For example, infections with CRE are difficult to treat, as there are limited treatment choices available. Mortality rates as high as 40% to 50% have been associated with CRE infections, making them a serious threat to public health. The available treatment choices are associated with serious potential toxicity, in the case of colistin and aminoglycosides, or concerns of allergy or hypersensitivity, in the case of β-lactams or penicillin derivatives.

Our Solution: CONTEPO for the Treatment of cUTI

· CONTEPO is an IV formulation of fosfomycin and the sole member of the epoxide antibiotic class.

· CONTEPO has a different mechanism of action than other IV antibiotics in the United States.

· CONTEPO has a broad spectrum of in vitro activity against a variety of clinically important MDR Gram-negative pathogens, including ESBL-producing Enterobacteriaceae, CRE, and Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (“MRSA”) and vancomycin-resistant enterococci.

· CONTEPO has demonstrated in in vitro studies additivity or synergy when used in combination with other classes of antibiotic agents in pre-clinical trials.

· CONTEPO has a small molecular size, which may enable high levels of tissue penetration and facilitates renal elimination, both of which are important for treatment of cUTIs.

· CONTEPO is supported by a long history of IV fosfomycin use outside the United States in a variety of indications, including cUTI.

· CONTEPO has completed the ZEUS Study, a pivotal registrational Phase 2/3 clinical trial in cUTI, achieving non-inferiority to an active comparator.

CONTEPO is a potentially first-in-class epoxide IV antibiotic in the United States with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against many contemporary MDR strains that threaten hospitalized patients. IV fosfomycin has an extensive commercial history in markets outside the United States, where it has been used broadly for over 45 years to treat a variety of indications, including complicated urinary tract infections, bacteremia, pneumonia and skin infections.

CONTEPO works differently than other IV antibiotics approved in the United States. CONTEPO inhibits an early step in bacterial cell wall synthesis, so the cell wall lacks integrity and the bacteria die quickly. We believe that because of its different mechanism of action, we have not observed any cross resistance to date between CONTEPO and any of the existing classes of intravenous antibiotics. In addition, CONTEPO has demonstrated in in vitro studies an additive or synergistic antibacterial effect with other classes of antibiotics when used in combination therapy, and has been shown to restore susceptibility in resistant strains.

CONTEPO Clinical Development Program

CONTEPO is under development in the United States for the treatment of cUTI, including AP. The clinical development plan for CONTEPO utilized a modernized dosing regimen to optimize

coverage of the predominant pathogens in hospital infections, including strains recognized by the CDC as an urgent or serious antibiotic resistant threat to public health in the United States.

Phase 2/ 3 Clinical Trial

The ZEUS Study was a multicenter, randomized, parallel-group, double-blind, pivotal Phase 2/3 clinical trial designed to evaluate safety, tolerability, efficacy and pharmacokinetics of CONTEPO compared to PIP-TAZ in the treatment of hospitalized adults with cUTI or AP. PIP-TAZ is a combination antibiotic consisting of a broad-spectrum antibiotic, piperacillin, plus a BLI, tazobactam, which extends the antibiotic spectrum of piperacillin to include many β-lactamase-producing bacteria that have acquired resistance to piperacillin alone. PIP-TAZ is widely used to treat serious Gram-negative infections. The primary objective of the ZEUS Study was to demonstrate that CONTEPO was non-inferior to PIP-TAZ in overall success based on clinical cure and microbiologic eradication in the microbiologic modified intent-to-treat (“m-MITT”) population at the test-of-cure visit (“TOC”), which occurred on the 19 th to 21 st day after completion of seven days of treatment with the study drug, or after up to 14 days of treatment for patients with concurrent bacteremia. The m-MITT population consisted of 362 patients, each of whom met the study’s inclusion criteria, was randomized, received any amount of study drug, and had one or more baseline Gram-negative pathogens growing at greater than or equal to 10(5) CFU/mL from an appropriately collected, pre-treatment baseline urine or blood sample. The primary endpoint was a composite of the investigator’s determination of clinical cure, meaning complete resolution or significant improvement of signs and symptoms that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted, plus microbiologic eradication, meaning that the baseline bacterial pathogen was reduced to less than 10(4) CFU/mL on urine culture and, if applicable, negative on repeat blood culture, both in the m-MITT population at TOC. Any missing or presumed eradications were classified as indeterminates, and conservatively counted as failures in the overall success analysis.

All pathogens isolated from patients who had a baseline and TOC pathogen underwent blinded, post-hoc, pulsed-field gel electrophoresis (“PFGE”) typing analysis. Microbiologic outcome was also defined utilizing the PFGE results, whereby microbiologic persistence required the same genus and species of baseline and post-baseline pathogens, as well as PFGE-confirmed genetic identity.

Patients eligible for the trial were required to be 18 years of age or older and have cUTI or AP that was considered by the clinical investigator to be serious enough to require hospitalization and IV antibiotic therapy. The diagnosis was based on pyuria, or the presence of pus or white blood cells in the urine, and cUTI or AP with at least two additional symptoms such as chills, rigors, or warmth associated with fever, nausea or vomiting, painful, difficult or frequent urination, lower abdominal or pelvic pain, or acute flank pain. Patients with cUTI were also required to have at least one risk factor, such as use of intermittent or indwelling bladder catherization; functional or anatomical abnormality of the urogenital tract; complete or partial hindrance of normal urine flow; blood urea nitrogen greater than 20 mg/dL; blood urea greater than 42.8 mg/dL, or serum creatinine greater than 1.4 mg/dL, due to known prior renal disease; or, in male patients, chronic urinary retention. A baseline urine culture specimen was obtained within 48 hours prior to randomization, and any indwelling bladder catheters were required to be removed or replaced, unless such removal was considered unsafe or contraindicated, before or within 24 hours after randomization.

Eligible patients were randomly assigned to receive either CONTEPO (6 grams IV fosfomycin) or PIP-TAZ (4 grams piperacillin/0.5 grams tazobactam) as one-hour infusions three times daily for seven days, except patients with concurrent bacteremia, who could have received treatment for up to 14 days at the clinical investigator’s discretion. Oral step down therapy was prohibited. Throughout the study, all patients were monitored for signs and symptoms of cUTI or AP and the occurrence of adverse events. Laboratory data, including chemistry panels, complete blood counts, electrocardiograms, and samples for urine and blood cultures were collected from all patients at specified times throughout the study.

Of the total of 465 patients randomized across 92 sites in 16 countries, with studies conducted at 74 sites in 15 countries, 464 (99.8%) received at least one dose of the study drug. Of the 464 patients who received at least one dose of study drug, 233 patients were in the CONTEPO treatment group, and 231 patients were in the PIP-TAZ treatment group. The incidence of premature discontinuation from study drug was low and similar between treatment groups (6.0% in the CONTEPO treatment group compared to 3.9% in the PIP-TAZ treatment group), and the incidence of not completing the study through the last follow-up visit (“LFU”), which occurred on the 24 th through 28 th day after completion of seven days of treatment with the study drug, or after up to 14 days of treatment for patients with concurrent bacteremia, was 5.2% in the CONTEPO group compared to 0.9% in the PIP-TAZ group.

In the ZEUS Study, CONTEPO was non-inferior to PIP-TAZ for the primary efficacy outcome of overall success, which was defined as clinical cure and microbiologic eradication at TOC. Overall success occurred in 64.7% of CONTEPO patients and 54.5% of PIP-TAZ patients. The treatment difference between the CONTEPO and PIP-TAZ groups was 10.2%, with a 95% confidence interval (-0.4, 20.8). Additionally, the lower bound of the 95% confidence interval met the pre-specified non-inferiority margin of -15%, demonstrating that CONTEPO was non-inferior to PIP-TAZ in the study. In a post-hoc primary efficacy analysis using results of blinded PFGE molecular typing of urinary tract pathogens, this difference was even greater (69.0% CONTEPO patients compared to 57.3% PIP-TAZ patients, with a treatment difference of 11.7%, with a 95% confidence interval (1.3, 22.1). Overall success rates were driven by microbiologic eradication rates, as clinical cure rates were greater than 90% and treatment differences were small at TOC. Using the PFGE molecular typing, the microbiologic eradication rates in the m-MITT population at the TOC were 70.7% for patients receiving CONTEPO compared to 60.1% for patients receiving PIP-TAZ. These rates were consistent with those observed in some contemporary cUTI studies, and most patients with microbiologic persistence at TOC had identifiable reasons or risk factors for persistence, such as functional or anatomical abnormalities of the urogenital tract, recent or indwelling urinary tract catheterization, elevated minimum inhibitory concentration (MIC) to the study drug received, abbreviated study drug therapy, or other underlying co-morbidities. Of note, a majority of patients with microbiologic persistence at TOC were clinical cures at TOC, did not require rescue antimicrobial therapy, and remained sustained cures at LFU.

The identity and frequency of pathogens recovered at baseline from patients in the ZEUS Study were similar in both the CONTEPO and PIP-TAZ treatment groups. The most common pathogens identified were Enterobacteriaceae, identified in 96.2% of the CONTEPO patients and 94.9% of the PIP-TAZ patients, including E. coli, identified in 72.3% of the CONTEPO patients and 74.7% of the PIP-TAZ patients; K. pneumoniae, identified in 14.7% of the CONTEPO patients and 14.0% of the PIP-TAZ patients; Enterobacter cloacae species complex, identified in 4.9% of the

CONTEPO patients and 1.7% of the PIP-TAZ patients; and Proteus mirabilis, identified in 4.9% of the CONTEPO patients and 2.8% of the PIP-TAZ patients. Gram-negative aerobes other than Enterobacteriaceae included Psuedomonas aeruginosa, which was identified in 4.3% of the CONTEPO patients and 5.1% of the PIP-TAZ patients, and Acinetobacter baumannii-calcoaceticus species complex, identified in 1.1% of the CONTEPO patients and no PIP-TAZ patients. These pathogens are representative of the pathogens that have been recovered in other studies of patients with cUTI or AP. For the predominant pathogens E. coli and K. pneumoniae, the clinical cure rates at TOC for CONTEPO were greater than 90% for both pathogens, and microbiologic eradication rates were 68.4%, or 72.9% with PFGE analysis, for E. coli, and 66.7% for K. pneumoniae on both a non-PFGE analysis and PFGE analysis-basis.

A total of 42.1% CONTEPO patients and 32.0% PIP-TAZ patients experienced at least one treatment-emergent adverse event (“TEAE”). Most TEAEs were mild or moderate in severity, and severe TEAEs were uncommon (2.1% of CONTEPO patients and 1.7% of PIP-TAZ patients). The most common TEAEs in both treatment groups were transient, asymptomatic laboratory abnormalities and gastrointestinal events. Treatment-emergent serious adverse events (“SAEs”) were uncommon in both treatment groups (2.1% of CONTEPO patients and 2.6% of PIP-TAZ patients). There were no deaths in the study and one SAE in each treatment group was deemed related to the study drug (hypokalemia in a CONTEPO patient and renal impairment in a PIP-TAZ patient), leading to study drug discontinuation in the PIP-TAZ patient. Study drug discontinuations due to TEAEs were infrequent and similar between treatment groups (3.0% of CONTEPO patients and 2.6% of PIP-TAZ patients).

The most common laboratory abnormality TEAEs were increases in the levels of alanine aminotransferase (8.6% of CONTEPO patients and 2.6% of PIP-TAZ patients) and aspartate transaminase (7.3% of CONTEPO patients and 2.6% of PIP-TAZ patients). None of the aminotransferase elevations were symptomatic or treatment-limiting, and none of the patients met the criteria for Hy’s Law. Outside of the United States, elevated liver aminotransferases are listed among undesirable effects in labeling for IV fosfomycin.

Hypokalemia occurred in 71 of 232 (30.6%) CONTEPO patients and 29 of 230 (12.6%) PIP-TAZ patients. Most decreases in potassium levels were mild to moderate in severity. Shifts in potassium levels from normal at baseline to hypokalemia, as determined by worst post-baseline hypokalemia values, were more frequent in the CONTEPO group than the PIP-TAZ group for mild (17.7% compared to 11.3%), moderate (11.2% compared to 0.9%), and severe (1.7% compared to 0.4%) categories of hypokalemia. Hypokalemia was deemed a TEAE in 6.4% of patients receiving CONTEPO and 1.3% of patients receiving PIP-TAZ, and all cases were transient and asymptomatic. While no significant cardiac adverse events were observed in the ZEUS Study, post-baseline QT intervals calculated using Fridericia’s formula (“QTcF”) of greater than 450 to less than or equal to 480 msec (baseline QTcF of less than or equal to 450 msec) occurred at a higher frequency in CONTEPO patients (7.3%) compared to PIP-TAZ patients (2.5%). In the CONTEPO arm, these results appear to be associated with the hypokalemia associated with the salt load of the IV formulation. Only one patient in the PIP-TAZ group had a baseline QTcF of less than or equal to 500 msec and a post-baseline QTcF of greater than 500 msec.

Phase 1 Pediatric Clinical Trial

In June 2018, we initiated a phase 1, non-comparative, open-label study of the pharmacokinetics and safety of a single dose of CONTEPO in pediatric subjects less than 12 years of age receiving standard-of-care antibiotic therapy for proven or suspected infection or peri-operative prophylaxis. A total of 24 patients are expected to be enrolled at up to ten clinical sites in the United States. We anticipate completing enrollment in this study in late 2020.

Potential Additional Indications for CONTEPO

Fosfomycin has a long history of use outside the United States in a variety of indications beyond cUTI. The FDA has granted both Fast Track and QIDP designations for the investigation of CONTEPO for the following indications in addition to cUTI:

· Complicated intra-abdominal infections (cIAI)

· Hospital-acquired bacterial pneumonia (HABP)

· Ventilator-associated bacterial pneumonia (VABP)

· Acute bacterial skin and skin structure infections (ABSSSI)

In August 2017, Zavante entered into an agreement with the United States National Institute of Allergy and Infectious Diseases (“NIAID”), under which NIAID will conduct a clinical trial to assess CONTEPO’s intrapulmonary penetration and pharmacokinetics in support of the product candidate’s potential future development as a treatment for HABP and VABP. This bronchoalveolar lavage study (the “BAL study”) will measure CONTEPO’s pulmonary penetration by assessing drug concentrations in the lining of study subjects’ bronchial pathways. Diffusion and saturation of antibiotics in patients’ airways are considered important factors in assessing a drug’s ability to effectively treat lower-respiratory tract infections. Prior preclinical and clinical investigations of IV fosfomycin have demonstrated that the product candidate penetrates rapidly into tissues and achieves clinically relevant concentrations in urine, soft tissues, lungs and other organs, supporting CONTEPO’s potential versatility as an antibiotic treatment option. The protocol for the BAL study is currently under development in conjunction with NIAID, and we anticipate that the study will be initiated in late 2018.

Commercialization Strategy

Our strategic intention, supported by CONTEPO’s differentiated profile, is to establish CONTEPO as the standard of care in the United States for hospitalized patients with serious infections caused by suspected or confirmed MDR bacteria. We plan to use a targeted sales force to promote CONTEPO to hospital-based healthcare professionals in key locations within the United States where MDR infections, including CRE, are concentrated. These include roughly 900 hospitals in resistance hotspots such as New York City, Los Angeles and Chicago, and other major population centers. We also plan to deploy a highly experienced medical science liaison team to provide appropriate medical education.

Competition

If approved, we expect CONTEPO will face competition from commercially available antibiotics such as ceftazidime-avibactam, meropenem-vaborbactam, tigecycline, plazomicin, from other products currently in development for the treatment of cUTI, including AP, such as imipenem-relebactam (under Phase 3 clinical development by Merck), cefiderocol (under Phase 3 clinical development by Shionogi), eravacycline (under development by Tetraphase), sulbactam-ETX2514 (under development by Entasis), and LYS228 (under development by Novartis), as well as generically available agents including carbapenems, aminoglycosides, and polymyxins. However, we believe CONTEPO’s differentiated mechanism of action and activity against MDR pathogens create the potential for CONTEPO to be an appropriate initial therapy to allow clinicians to spare carbapenems and other last line therapies.

Manufacturing

We rely on third parties to manufacture CONTEPO for use in clinical trials and potential commercial supply, and our strategy is to outsource all manufacturing, packaging, testing, serialization and distribution of this product candidate. However, we have significant in-house knowledge and experience in the relevant manufacturing and supply chain processes associated with CONTEPO.

We have entered into agreements with third-party manufacturers for the long-term, commercial supply of CONTEPO. We obtain fosfomycin disodium, the active ingredient in CONTEPO, from a single, third-party manufacturer under an exclusive manufacturing and supply agreement for the United States. A separate third-party manufacturer is responsible for filling the product into vials, the primary container closure system. Bulk filled vials are shipped to another third-party manufacturer for labeling, serialization and final packaging. Our manufacturing agreements are described in more detail below.

Zavante Agreements

Stock Purchase Agreement with SG Pharmaceuticals

On May 5, 2015, former stockholders of Zavante (the “Selling Stockholders”), entered into a stock purchase agreement (the “Stock Purchase Agreement”), with SG Pharmaceuticals, Inc. (“SG Pharmaceuticals”), pursuant to which SG Pharmaceuticals acquired all of the outstanding capital stock of Zavante from the Selling Stockholders. SG Pharmaceuticals subsequently merged with and into Zavante, with Zavante as the surviving entity. As consideration for the acquisition, SG Pharmaceuticals paid $500,000 in cash and issued 1,420,000 shares of SG Pharmaceuticals common stock to the Selling Stockholders on a pro rata basis. Pursuant to the Stock Purchase Agreement, Zavante (as successor to SG Pharmaceuticals, Inc.) is obligated to make a milestone payment to the selling stockholders of $3.0 million upon marketing approval by the FDA with respect to any oral, intravenous or other form of fosfomycin, or the Zavante Products and milestone payments of up to $26 million in the aggregate

upon the occurrence of various specified levels of net sales with respect to the Zavante Products. In addition, Zavante is obligated to make annual royalty payments to the Selling Stockholders of a mid single-digit percentage of net sales of Zavante Products, subject to adjustment based on net sales thresholds and with such percentage reduced to low single-digits if generic fosfomycin products account for half of the applicable market on a product-by-product and country-by-country basis. The Stock Purchase Agreement also provides that Zavante will pay to the Selling Stockholders a mid single-digit percentage of transaction revenue in connection with the consummation of the grant, sale, license or transfer of market exclusivity rights for a qualified infectious disease (within the meaning of the 21st Century Cures Act, or the Cures Act) related to a Zavante Product. Additionally, in 2016, Zavante paid a $1.5 million cash milestone payment to the Selling Stockholders, on a pro rata basis, upon the closing of a Series A financing for Zavante.

Sorrento R&D Office Lease

Effective as of June 16, 2016, Zavante entered into a lease (the “Sorrento Lease”), with AGP Sorrento R&D, LP, pursuant to which Zavante leases approximately 4,420 square feet of office space in San Diego, California. The Sorrento Lease is non-cancelable and has an initial term of 36 months, with an option to extend the term for an additional 36 months. Zavante’s contractual obligation with respect to lease payments under the Sorrento Lease over the initial lease term is approximately $341,200, plus Zavante’s share of taxes and certain building complex expenses shared pro rata among Zavante and other tenants. As of June 30, 2018, the remaining lease liability is $121,000 plus pro rata expenses.

Three-Way Agreement with ERN and Ercros

Effective July 28, 2016, Zavante, Laboratorios ERN, S.A. (“ERN”) and Ercros, S.A. (“Ercros”) entered into an Amended and Restated Three-Way Agreement (the “Three-Way Agreement”), which established the basis for related supply agreements with ERN and Ercros in anticipation of FDA approval of fosfomycin disodium and succinic acid injection for intravenous use filled, finished and packaged into containers for use by end users (“Product”) in the United States. Pursuant to the Three-Way Agreement, Zavante has the direct responsibility for the manufacture and supply of the commercial Product in the United States.

Under the Three-Way Agreement, (i) ERN has agreed to provide Zavante with certain technical documentation and data required for submission of an NDA or Abbreviated New Drug Application, as applicable (collectively, “NDA”), for the Product (“Technical Documentation”), and other assistance in connection with the submission of an NDA, pursuant to the ERN Supply Agreement (as defined below); (ii) Ercros has agreed to provide Zavante with certain Technical Documentation and the manufacture and supply of a blend of fosfomycin disodium and succinic acid (the “API Mixture”) for the manufacture of the Product, pursuant to the terms of the Ercros Supply Agreement (as defined below); and (iii) Zavante has agreed to obtain the commercial supply of the Product, under one or more separate agreements with third party manufacturers. The rights and obligations of each of the parties are set forth in each of the ERN Supply Agreement and the Ercros Supply Agreement.

In addition, pursuant to the Three-Way Agreement, Zavante is required to (i) contract with one or more third party manufacturers to provide quantities of the Product required by Zavante for commercial sale in the United States, perform validation activities as required by the FDA, and obtain FDA approval of such third party manufacturer’s facilities and quality systems; (ii) use commercially reasonable efforts to file an NDA within one year of its receipt of all Technical Documentation for the NDA from ERN and Ercros; (iii) obtain and own all trademarks to be used for the Product in the United States and (iv) bear the cost and manage all clinical trials necessary for obtaining FDA approval of the Product and keep ERN and Ercros updated regarding the progress of such clinical trials.

The Three-Way-Agreement will continue in force and effect until the Ercros Supply Agreement and the ERN Supply Agreement have both been terminated or expired in accordance with the respective terms therein, or if the Three-Way Agreement is terminated upon mutual written agreement of all of the parties. The Three-Way Agreement contains, among other provisions, customary provisions relating to legal compliance and publicity.

Ercros Supply Agreement

Effective July 28, 2016, Zavante and Ercros entered into a Manufacturing and Supply Agreement (the “Ercros Supply Agreement”) pursuant to the Three-Way Agreement. Under the Ercros Supply Agreement, Ercros has agreed, pursuant to purchase orders entered into under the Ercros Supply Agreement, to manufacture (i) the exclusive supply of the API Mixture for Zavante in support of filing an NDA or an Abbreviated New Drug Application (“ANDA”), as applicable, and (ii) the commercial supply of fosfomycin disodium and succinic acid injection for intravenous use in the United States. In addition, Ercros has agreed to provide access to certain technical documentation as may be requested by Zavante in connection with the filing of an NDA.

The Ercros Supply Agreement has an initial ten-year term ending July 28, 2026 and will automatically renew after the initial term for additional two-year terms unless either party gives notice of its intention to terminate the Ercros Supply Agreement at least 18 months prior to the end of the then-current term. Either party may terminate the Ercros Supply Agreement for the other party’s uncured material breach, in addition to other specified events, including with respect to bankruptcy proceedings, governmental actions and legal proceedings, in each case subject to notice, cure periods and other conditions set forth in the Ercros Supply Agreement.

The Ercros Supply Agreement contains customary supply terms, including requirements forecasting, purchase orders, product specifications, price, payment terms, delivery mechanics and quality insurance. In addition, the Ercros Supply Agreement contains, among other provisions, customary representations and warranties by the parties, a grant by Ercros to Zavante of certain limited license rights to Ercros’ intellectual property in connection with Zavante’s performance under the Ercros Supply Agreement, certain indemnification rights in favor of both parties and customary confidentiality provisions.

Under the Ercros Supply Agreement, Zavante and Ercros have also entered into a quality agreement, pursuant to which Ercros will conduct all quality control and release testing for the API Mixture produced under the Ercros Supply Agreement.

ERN Supply Agreement

Effective July 28, 2016, Zavante and ERN entered into an Amended and Restated Pharmaceutical Manufacturing and Exclusive Supply Agreement, or the ERN Supply Agreement, as amended on December 1, 2016, March 1, 2017, May 1, 2017 and December 20, 2017, pursuant to the Three-Way Agreement. Under the ERN Supply Agreement, each party is required to use commercially reasonable efforts to complete certain development activities required for submission of an NDA or an ANDA for fosfomycin sodium and succinic acid (the bulk formulation of CONTEPO). In addition, ERN has agreed to provide to Zavante (i) certain technical documentation and data as required by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s guidelines and the FDA for submission of an NDA or an ANDA for the bulk formulation of CONTEPO, and (ii) certain regulatory support in connection with the bulk formulation of CONTEPO sold or intended for commercial sale and human use.

Upon the first commercial sale of the bulk formulation of CONTEPO, Zavante is obligated to make a one-time cash payment to ERN and subsequent quarterly payments thereafter based on the number of vials of the bulk formulation of CONTEPO sold during each calendar quarter.

The ERN Supply Agreement has an initial ten-year term ending July 28, 2026 and will automatically renew after the initial term for additional two-year terms unless either party gives notice of its intention to terminate the ERN Supply Agreement at least 18 months prior to the end of the then-current term. Either party may terminate the ERN Supply Agreement by mutual written agreement and for the other party’s uncured material breach, in addition to other specified events, including with respect to bankruptcy proceedings and governmental actions, in each case subject to notice, cure periods and other conditions set forth in the ERN Supply Agreement.

The ERN Supply Agreement contains, among other provisions, customary representations and warranties by the parties, a grant to each party by the other party of certain limited license rights to such other party’s intellectual property in connection with the parties’ performance of the services under the ERN Supply Agreement, certain indemnification rights in favor of both parties and customary confidentiality provisions.

Fisiopharma Supply Agreement

On April 25, 2017, Zavante and Fisiopharma, S.r.l. (“Fisiopharma”) entered into a Manufacturing and Supply Agreement, as amended on May 8, 2017 (the “Fisiopharma Supply Agreement”). Under the Fisiopharma Supply Agreement, Fisiopharma has agreed, pursuant to purchase orders entered into under the Fisiopharma Supply Agreement, to manufacture and supply fosfomycin disodium for intravenous injection in bulk drug vials (the “Bulk Drug Vials”) to Zavante in support of filing an NDA or an ANDA, as applicable, and a specified percentage of Zavante’s commercial requirements of Bulk Drug Vials for the United States.

The Fisiopharma Supply Agreement has an initial ten-year term ending April 25, 2027 and will automatically renew after the initial term for additional one-year terms unless Zavante gives notice of its intention to terminate the Fisiopharma Supply Agreement at least six months prior to the end of the then-current term. Either party may terminate the Fisiopharma Supply Agreement for the other party’s uncured material breach or upon the occurrence of specified bankruptcy events, and Zavante may terminate the Fisiopharma Supply Agreement upon the occurrence of other specified events, including with respect to governmental actions and legal proceedings instituted against Fisiopharma, in each case subject to notice, cure periods and other conditions set forth in the Fisiopharma Supply Agreement.

The Fisiopharma Supply Agreement contains customary supply terms, including requirements forecasting, purchase orders, product specifications, price, payment terms, delivery mechanics and quality insurance. In addition, it contains, among other provisions, customary representations and warranties by the parties, a grant to Fisiopharma of certain limited license rights of Zavante’s intellectual property in connection with Fisiopharma’s performance of services under the Fisiopharma Supply Agreement, certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions.

Under the Fisiopharma Supply Agreement, Zavante and Fisiopharma have also entered into a quality control agreement, pursuant to which Fisiopharma will conduct all quality control and release testing for the Bulk Drug Vials produced under the Fisiopharma Supply Agreement. Any default under the quality agreement constitutes a default under the Ercros Supply Agreement.

PCI Commercial Packaging Agreement

On December 26, 2017, Zavante entered into a Commercial Packaging Agreement (the “Packaging Agreement”) with AndersonBrecon Inc., doing business as PCI of Illinois (“PCI”) for the commercial packaging of fosfomycin disodium for intravenous injection in bulk drug vials (the “Packaged Product”). Under the Packaging Agreement, PCI has agreed to provide certain packaging services to Zavante, including labeling, serialization and final packaging of the Packaged Product.

The Packaging Agreement has an initial three-year term ending December 26, 2020 and will automatically renew after the initial term for additional one-year terms unless either party gives notice of its intention to terminate the Packaging Agreement at least 120 days prior to the end of the then-current term. In addition, either party may terminate the Packaging Agreement for the other party’s uncured material breach, in addition to other specified events, including with respect to bankruptcy proceedings and governmental actions, in each case subject to notice, cure periods and other conditions set forth in the Packaging Agreement.

The Packaging Agreement contains customary supply terms, including product specifications, price, payment terms, delivery mechanics and quality insurance. In addition, it contains, among other provisions, customary representations and warranties by the parties, a grant to PCI of certain limited license rights of Zavante’s intellectual property in connection with PCI’s performance of services under the Packaging Agreement certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions.

Under the Packaging Agreement, Zavante and PCI have also entered into contract services quality agreement, which governs the responsibilities of each party regarding the quality aspects of packaging and release of Packaged Product.

Intellectual Property

Zavante holds one issued United States patent (U.S. 9,345,717) directed to methods for identifying dosing regimens that decrease the potential for on-therapy drug resistance. Additionally, Zavante has filed a patent application based on results from the ZEUS Study that relates to methods for treating patients with resistant bacterial infections and, specifically, Gram-negative bacterial infections. However, this patent may not ensure exclusivity through the patent term and we may not be able to secure any additional patent protection. We plan to rely on regulatory protection afforded to CONTEPO through orphan drug designations, data exclusivity, and market exclusivity where available.

Zavante’s policy is to obtain and defend patent rights and protect its technology, inventions and improvements that are commercially important to the development of its business. In addition to patents, Zavante relies on trade secrets and know-how related to the manufacture and analytical testing of CONTEPO to develop and protect its competitive position. Zavante also protects its proprietary data, methods and processes by entering into confidentiality agreements and invention assignment agreements with its employees, consultants, advisors, contractors, and business partners.

Item 9.01. Financial Statements and Exhibits.

(a) Financial Statements of Businesses Acquired.

(i) The audited financial statements of Zavante Therapeutics, Inc. as of and for the years ended December 31, 2017 and 2016 and the independent auditors’ report thereon are filed as Exhibit 99.2 hereto and are incorporated into this Item 9.01(a) by reference.

(ii) The unaudited financial statements of Zavante Therapeutics, Inc. required by this item have not been filed on this Current Report on Form 8-K but will be filed by amendment not later than 71 calendar days after the date that this Current Report on Form 8-K was required to be filed.

(b) Pro Forma Financial Information.

The pro forma financial information required by this item has not been filed on this Current Report on Form 8-K but will be filed by amendment not later than 71 calendar days after the date that this Current Report on Form 8-K was required to be filed.

(d) Exhibits.

EXHIBIT INDEX

Exhibit
No.		Description

2.1*		Agreement and Plan of Merger dated as of July 23, 2018, by and among Nabriva Therapeutics plc, Zuperbug Merger Sub I, Inc., Zuperbug Merger Sub II, Inc., Zavante Therapeutics, Inc. and Cam Gallagher, solely in his capacity as Stockholder Representative

10.1		Transition, Separation and Release of Claims Agreement, by and between Nabriva Therapeutics US, Inc. and Colin Broom, dated as of July 23, 2018

10.2		Employment Agreement, by and between Nabriva Therapeutics US, Inc. and Theodore Schroeder, dated as of July 23, 2018

10.3		Consulting Agreement, by and between Nabriva Therapeutics US, Inc. and Colin Broom, dated as of July 24, 2018 (included as Attachment A to Exhibit 10.1)

23.1		Consent of Independent Auditors

99.1		Risk Factors of Nabriva Therapeutics plc

99.2		Audited financial statements of Zavante Therapeutics, Inc. as of and for the years ended December 31, 2017 and 2016 and the independent auditors’ report thereon

* Confidential treatment has been requested for certain portions that are omitted from this exhibit. The omitted information has been filed separately with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the registrant’s application for confidential treatment. In addition, schedules have been omitted from this exhibit pursuant to Item 601(b)(2) of Regulation S-K. A copy of any omitted schedule will be furnished supplementally to

the SEC upon request; provided, however, that the registrant may request confidential treatment for any document so furnished.

Forward-looking Statements

Any statements in this Form 8-K about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the Acquisition and the other transactions contemplated by the Acquisition and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements related to Nabriva Therapeutics’ expectations with respect to the potential financial impact and benefits of the Acquisition, including Nabriva Therapeutics’ expectations with respect to milestone payments pursuant to the Merger Agreement and expectations with respect to and potential advantages of CONTEPO as well as any statements with respect to the development of Nabriva Therapeutics’ product candidates, such as the future development or commercialization of lefamulin and CONTEPO, conduct and timelines of clinical trials, the clinical utility of lefamulin for CABP and of CONTEPO for cUTI and plans for filing of regulatory approvals and efforts to bring lefamulin and CONTEPO to market, the market opportunity for and the potential market acceptance of lefamulin for CABP and CONTEPO for cUTI, the development of lefamulin for additional indications, the development of additional formulations of lefamulin and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to realize the anticipated benefits, synergies and growth prospects of the Acquisition, including the possibility that the expected benefits from the Acquisition will not be realized or will not be realized within the expected time period or at all, negative effects of the announcement of the Acquisition on the market price of Nabriva Therapeutics’ ordinary shares, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the Acquisition, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, whether results of Nabriva Therapeutics’ first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, whether results of ZEUS will be indicative of results for any ongoing or future clinical trials and studies of CONTEPO, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP and CONTEPO for the treatment of cUTI, whether regulatory or commercial milestones under the Merger Agreement are achieved, whether the regulatory and commercial milestones, royalty and transaction revenue payment obligations under the Stock Purchase Agreement are achieved, Nabriva Therapeutics’ ability to successfully integrate Zavante Therapeutics’ business into its business, any challenges associated with Nabriva Therapeutics’ chief executive officer transition in connection with the Acquisition, Nabriva Therapeutics’ ability to retain and hire key personnel, the risk that disruption resulting from the Acquisition may adversely affect Nabriva Therapeutics’ business and business relationships, including with employees and suppliers, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth in Exhibit 99.3 hereto and under the caption “Risk Factors” in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this Form 8-K represent Nabriva Therapeutics’ views as of the date of this Form 8-K. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this Form 8-K.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	NABRIVA THERAPEUTICS PLC

Date: July 25, 2018	By:	/s/ Robert Crotty
		Robert Crotty
		General Counsel and Secretary

Exhibit 2.1

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions.

AGREEMENT AND PLAN OF MERGER

dated as of

July 23, 2018

by and among

NABRIVA THERAPEUTICS PLC,

ZUPERBUG MERGER SUB I, INC.,

ZUPERBUG MERGER SUB II, INC.,

ZAVANTE THERAPEUTICS, INC.

and

CAM GALLAGHER

TABLE OF CONTENTS

			Page
ARTICLE I. CERTAIN DEFINITIONS			2

	1.1	Definitions	2
	1.2	Construction	14
	1.3	Knowledge	15

ARTICLE II. THE MERGER; CLOSING			15

	2.1	First Merger and Second Merger	15
	2.2	Effects of the Merger	16
	2.3	Closing; Effective Time	16
	2.4	Certificate of Incorporation and Bylaws	17
	2.5	Directors and Officers	18

ARTICLE III. EFFECTS OF THE MERGER ON THE CAPITAL STOCK AND EQUITY AWARDS			18

	3.1	Conversion of Company Shares; Treatment of Company Options; Treatment of Company Warrant	18
	3.2	Closing Payments and Exchange of Certificates	22
	3.3	Estimated Adjustment Amount	23
	3.4	Adjustment Amount	23
	3.5	Stockholder Representative Expenses	25
	3.6	Exchange Agent	26
	3.7	Lost Certificates	26
	3.8	Dissenting Shares	27
	3.9	Withholding	27
	3.10	Milestone Payments	28
	3.11	Legend	34
	3.12	No Fractional Shares	34
	3.13	Issuance of Shares after Closing	34

ARTICLE IV. REPRESENTATIONS AND WARRANTIES OF THE COMPANY			35

	4.1	Corporate Organization of the Company	35
	4.2	Subsidiaries	35
	4.3	Due Authorization	35
	4.4	No Conflict	35
	4.5	Governmental Consents	36
	4.6	Capitalization of the Company	36
	4.7	Financial Statements	38
	4.8	Undisclosed Liabilities	38
	4.9	Litigation and Proceedings	38
	4.10	Compliance with Laws	39

	4.11	FDA Matters	39
	4.12	Contracts; No Defaults	40
	4.13	Company Benefit Plans	42
	4.14	Employment and Labor Relations	44
	4.15	Taxes	45
	4.16	Brokers’ Fees	48
	4.17	Insurance	48
	4.18	Licenses, Permits and Authorizations	48
	4.19	Real Property	49
	4.20	Intellectual Property	49
	4.21	Environmental Matters	51
	4.22	Absence of Changes	52
	4.23	Affiliate Matters	52
	4.24	No Outside Reliance	52
	4.25	Unaccredited Investors	53
	4.26	No Additional Representations or Warranties	53

ARTICLE V. REPRESENTATIONS AND WARRANTIES OF BUYER AND MERGER SUBS			53

	5.1	Corporate Organization	53
	5.2	Subsidiaries	53
	5.3	Due Authorization	54
	5.4	No Conflict	54
	5.5	Governmental Consents	54
	5.6	Capitalization of Buyer	55
	5.7	Financial Statements	55
	5.8	Undisclosed Liabilities	56
	5.9	Litigation and Proceedings	56
	5.10	Compliance with Laws	56
	5.11	FDA Matters	56
	5.12	Contracts; No Defaults	58
	5.13	Taxes	58
	5.14	Brokers’ Fees	61
	5.15	Licenses, Permits and Authorizations	61
	5.16	Intellectual Property	61
	5.17	Environmental Matters	62
	5.18	Absence of Changes	62
	5.19	Financial Ability; Issuance of Buyer Ordinary Shares	62
	5.20	SEC Filings, Sarbanes-Oxley and Exchange Rules	63
	5.21	No Outside Reliance	64
	5.22	No Additional Representations or Warranties	64

ARTICLE VI. COVENANTS OF THE COMPANY			64

	6.1	Conduct of Business	64
	6.2	Inspection	67

	6.3	Information Statement	67
	6.4	Termination of 401(k) Plan	68
	6.5	Section 280G Vote	68

ARTICLE VII. COVENANTS OF BUYER			68

	7.1	Director & Officer Indemnification and Insurance	68
	7.2	Employment Matters	70
	7.3	Retention of Books and Records	72
	7.4	Contact with Customers and Suppliers	72
	7.5	Registration Rights	72
	7.6	Conduct of Business of Buyer	73
	7.7	Stock Exchange Listing	73
	7.8	Shareholder Approval	73

ARTICLE VIII. JOINT COVENANTS			73

	8.1	Support of Transaction	73
	8.2	Stockholder Approval	73
	8.3	Further Assurances	74
	8.4	Tax Matters	74
	8.5	Private Placement	76

ARTICLE IX. CONDITIONS TO OBLIGATIONS			77

	9.1	Conditions to the Obligations of Buyer, Merger Subs and the Company	77
	9.2	Conditions to the Obligations of Buyer and Merger Subs	77
	9.3	Conditions to the Obligations of the Company	78
	9.4	Waiver of Conditions; Frustration of Conditions	79

ARTICLE X. TERMINATION/EFFECTIVENESS			79

	10.1	Termination	79
	10.2	Effect of Termination	80

ARTICLE XI. INDEMNIFICATION			81

	11.1	Survival of Representations, Warranties and Covenants	81
	11.2	Indemnification	81
	11.3	Indemnification Claim Procedures	82
	11.4	Limitations on Indemnification Liability	84
	11.5	Set Off	86
	11.6	Holdback Shares	86
	11.7	Indemnification Sole and Exclusive Remedy	86
	11.8	Issuance of Holdback Shares	86
	11.9	Tax Treatment	87

iii

ARTICLE XII. STOCKHOLDER REPRESENTATIVE			87

	12.1	Designation and Replacement of Stockholder Representative	87
	12.2	Authority and Rights of the Stockholder Representative; Limitations on Liability	88

ARTICLE XIII. MISCELLANEOUS			88

	13.1	Waiver	88
	13.2	Notices	89
	13.3	Assignment	90
	13.4	Rights of Third Parties	91
	13.5	[Reserved]	91
	13.6	Expenses	91
	13.7	Governing Law	91
	13.8	Captions; Counterparts	91
	13.9	Schedules and Annexes	91
	13.10	Entire Agreement	92
	13.11	Amendments	92
	13.12	Publicity	92
	13.13	Severability	92
	13.14	Jurisdiction; Waiver of Jury Trial	93
	13.15	Enforcement	93
	13.16	Waiver of Conflicts Regarding Representations; Non-Assertion of Attorney-Client Privilege	94
	13.17	Tax Advice	95

Annexes

Annex A — Form of Support Agreement

Annex B-1 — Form of Certificate of Merger

Annex B-2 — Form of Second Certificate of Merger

Annex C — Form of Letter of Transmittal

Annex D — Form of Investment Agreement

Annex E — Form of Written Consent

Annex F — Form of Surrender Agreement

AGREEMENT AND PLAN OF MERGER

This Agreement and Plan of Merger (this “ Agreement ”), dated as of July 23, 2018, is entered into by and among Nabriva Therapeutics plc, a public limited company under the Laws of Ireland (“ Buyer ”), Zuperbug Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of Buyer (“ Merger Sub I ”), Zuperbug Merger Sub II, Inc., a Delaware corporation and a wholly owned subsidiary of Buyer (“ Merger Sub II ”, and together with Merger Sub I, “ Merger Subs ”), Zavante Therapeutics, Inc., a Delaware corporation (the “ Company ”), and Cam Gallagher, an individual, solely in his capacity as the initial Stockholder Representative hereunder.

RECITALS

WHEREAS, the respective Boards of Directors of Buyer, Merger Sub I and the Company have approved and declared advisable the First Merger (defined below) upon the terms and subject to the conditions of this Agreement and in accordance with the Delaware General Corporation Law (the “ DGCL ”);

WHEREAS, the respective Boards of Directors of Buyer, Merger Sub I and the Company have determined that the First Merger is in furtherance of and consistent with their respective business strategies and is fair to, and in the best interest of, their respective stockholders;

WHEREAS, Buyer, the Merger Subs and the Company intend to effect a reorganization in which, as steps in a single, integrated transaction, (a) the First Merger will be consummated, and (b) as part of the same overall transaction, the Company will merge with and into Merger Sub II, the Company will cease to exist, and Merger Sub II will survive as a direct, wholly owned subsidiary of Buyer (the “ Second Merger ” and, collectively or in seriatim with the First Merger, as appropriate, the “ Merger ”);

WHEREAS, the parties intend that the Merger qualify as a “reorganization” within the meaning of Section 368(a) of the Code, and that this Agreement be a “plan of reorganization” for purposes of Sections 354 and 361 of the Code and within the meaning of Section 1.368-2(g) of the Treasury Regulations;

WHEREAS, within two (2) Business Days after the execution and delivery of this Agreement, the Company will obtain and deliver to Buyer a true, correct and complete copy of an irrevocable written consent of stockholders of the Company in sufficient number to evidence the approval of this Agreement, the First Merger and the other transactions contemplated hereby in accordance with the DGCL;

WHEREAS, for certain limited purposes, and subject to the terms set forth herein, the Stockholder Representative shall serve as a representative of the Pre-Closing Holders (defined below); and

WHEREAS, concurrently with the execution and delivery of this Agreement as an inducement for Buyer and Merger Sub I to enter into this Agreement, certain of the Company Stockholders are executing and delivering the Support Agreement attached hereto as Annex A (the “ Support Agreement ”); and

WHEREAS, it shall be open to all holders of Company Capital Stock to receive Buyer Ordinary Shares in accordance with and subject to the terms set forth in this Agreement;

NOW, THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth in this Agreement and intending to be legally bound hereby, Buyer, Merger Subs, the Company and, solely in its capacity as such, the Stockholder Representative, agree as follows:

ARTICLE I.
CERTAIN DEFINITIONS

1.1 Definitions . As used herein, the following terms shall have the following meanings:

“ 2018 Company Bonus Payments ” has the meaning specified in Section 7.2(d) .

“ Acceleration Payment ” has the meaning specified in Section 3.10(f) .

“ Accredited Investor ” means an “accredited investor” as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.

“ Action ” means any claim, action, suit, audit, assessment, arbitration, inquiry, proceeding or investigation, in each case, by or before any Governmental Authority.

“ Adjustment Amount ” has the meaning specified in Section 3.4(c) .

“ Affiliate ” means, with respect to any specified Person, any Person that, directly or indirectly, controls, is controlled by, or is under common control with, such specified Person, through one or more intermediaries or otherwise. For the avoidance of doubt, following the Closing, (i) the Company shall constitute an Affiliate of Buyer and (ii) neither the Buyer nor any of its Subsidiaries (including the Company) shall constitute an Affiliate of any Pre-Closing Holder.

“ Agreement ” has the meaning specified in the preamble hereto.

“ Approval Milestone ” has the meaning specified in Section 3.10(a)(i) .

“ Base Shares ” means a number of Buyer Ordinary Shares (rounded down to the nearest whole share) equal to 19.9% of the total number of Buyer Ordinary Shares that are issued and outstanding as of immediately prior to the Closing.

“ Basket Amount ” has the meaning specified in Section 11.4(b) .

“ Business Day ” means any day that is not a Saturday, a Sunday or other day on which the Federal Reserve Bank of New York is closed.

“ Buyer ” has the meaning specified in the preamble hereto.

“ Buyer Closing Certificate ” has the meaning specified in Section 9.3(c) .

“ Buyer Cure Period ” has the meaning specified in Section 10.1(c)(i) .

“ Buyer Financial Statements ” has the meaning specified in Section 5.7 .

“ Buyer Indemnified Parties ” has the meaning specified in Section 11.2(a) .

“ Buyer Ordinary Shares ” means the ordinary shares, nominal value $0.01 per share, of Buyer.

“ Buyer Related Entities ” has the meaning specified in Section 3.10(b)(iv) .

“ Buyer SEC Documents ” means all registration statements, prospectuses, reports, schedules, forms, statements, and other documents (including exhibits and all other information incorporated by reference) required to be filed or furnished by it with the SEC since January 1, 2017.

“ Buyer Share Capital ” has the meaning specified in Section 5.6(a) .

“ Buyer Share Price ” means the volume weighted average price of a Buyer Ordinary Share over the twenty (20) trading-day period ending three (3) trading days prior to the Closing Date, as reported by Bloomberg.

“ Cancelled Shares ” has the meaning specified in Section 3.1(a) .

“ Capitalization Date ” has the meaning specified in Section 5.6(a)(i) .

“ Cash-Out Holder ” means any holder of Company Capital Stock who, having had the opportunity to qualify as a Qualified Holder, is not a Qualified Holder.

“ Certificate of Merger ” has the meaning specified in Section 2.1(a) .

“ Certificates ” has the meaning specified in Section 3.2(b) .

“ Change in Control Payments ” means any amounts payable by the Company, the Final Surviving Corporation or their Subsidiaries at or at any time after the Closing (or, to the extent such amounts are unpaid as of immediately prior to the Closing, at any time prior to the Closing) as a result of the execution and delivery of this Agreement or the consummation of the First Merger (whether or not conditioned upon a related termination of employment) to any current or former employee, officer, director or consultant of the Company pursuant to any plan, program, policy, Contract or arrangement adopted prior to the Closing providing for any transaction bonus, compensation or other similar amounts payable in connection with the consummation of the transactions contemplated by this Agreement (including all obligations with respect to the 2018 Company Bonus Payments or under the 2018 Corporate Bonus Plan), plus the employer’s share of Taxes payable with respect to all such amounts, provided , however , that in no event shall “Change in Control Payments” include: (i) amounts owed (x) as severance to any Company employee under a severance or change in control severance agreement to which the Company is a party and which is in effect as of prior to the Effective Time as a result of (A) any such employee’s termination of employment with Buyer or its Affiliates after June 30, 2019, (B) any actions taken by Buyer or its Affiliates after June 30, 2019 or (C) any breach of such agreement by Buyer or its Affiliates following the Closing, or (y) under arrangements put in place by the Buyer in connection

with the Closing or after the Effective Time; or (ii) amounts paid or payable in respect of Company Options in connection with the transactions contemplated by this Agreement.

“ Closing ” has the meaning specified in Section 2.3 .

“ Closing Balance Sheet ” means an unaudited balance sheet of the Company as of immediately prior to the Effective Time.

“ Closing Cash Amount ” means the amount of all cash and cash equivalents of the Company as of immediately prior to the Effective Time, to the extent that such amounts are not pledged as collateral or otherwise restricted, calculated in accordance with GAAP applied in a manner consistent with the principles applied in connection with the preparation of the most recent audited balance sheet included in the Financial Statements.

“ Closing Certificate ” has the meaning specified in Section 9.2(c) .

“ Closing Date ” has the meaning specified in Section 2.3 .

“ Closing Date Net Working Capital ” has the meaning specified in Section 3.4(a) .

“ Closing Indebtedness ” means all Indebtedness of the Company as of immediately prior to the Effective Time, calculated in accordance with GAAP applied in a manner consistent with the principles applied in connection with the preparation of the most recent audited balance sheet included in the Financial Statements.

“ Closing Indebtedness Amount ” means the amount of all Closing Indebtedness.

“ Closing Indebtedness Payoff Amount ” has the meaning specified in Section 3.3 .

“ Closing Merger Consideration ” has the meaning specified in Section 3.1(d) .

“ Closing Option Consideration ” has the meaning specified in Section 3.1(g) .

“ COBRA ” has the meaning specified in Section 4.13(f) .

“ Code ” means the United States Internal Revenue Code of 1986, as amended.

“ Company ” has the meaning specified in the preamble hereto.

“ Company Benefit Plans ” has the meaning specified in Section 4.13(a) .

“ Company Bylaws ” means the bylaws of the Company, as amended.

“ Company Capital Stock ” means the Company Common Stock and the Company Series A Preferred Stock.

“ Company Charter ” means the Amended and Restated Certificate of Incorporation of the Company, as amended.

“ Company Common Stock ” means the common stock, par value $0.0001 per share, of the Company.

“ Company Cure Period ” has the meaning specified in Section 10.1(c)(i) .

“ Company Equity Plan ” means the Company’s 2015 Equity Incentive Plan, as amended from time to time.

“ Company Intellectual Property ” means the Company Owned Intellectual Property and the Company Licensed Intellectual Property.

“ Company Licensed Intellectual Property ” means all Intellectual Property that is, or is purported to be, licensed to the Company, or with respect to which the Company has been given a covenant not to assert, by any third party.

“ Company Milestone Products ” has the meaning specified in Section 3.10(b)(i) .

“ Company Option ” has the meaning specified in Section 3.1(g).

“ Company Owned Intellectual Property ” means all Intellectual Property owned or purported to be owned by the Company, solely or jointly with any other Person.

“ Company Permits ” has the meaning specified in Section 4.18 .

“ Company Registered IP ” has the meaning specified in Section 4.20(a) .

“ Company Regulated Product ” has the meaning specified in Section 4.11(a) .

“ Company Restricted Stock Award ” means an award of shares of Company Common Stock granted pursuant to the Company Equity Plan or otherwise that is subject to restrictions based on continuing service.

“ Company Series A Preferred Stock ” means the Company’s Series A Preferred Stock, par value $0.0001 per share.

“ Company Stockholder ” means those Persons who held shares of outstanding Company Capital Stock immediately prior to the Effective Time (not inclusive of holders of Company Options or the Company Warrant).

“ Company Warrant ” means the outstanding warrant issued to PacWest Bancorp to purchase shares of Company Series A Preferred Stock.

“ Confidentiality Agreement ” has the meaning specified in Section 13.10 .

“ Continuing Employees ” has the meaning specified in Section 7.2(b) .

“ Contract ” means any written or oral contract, agreement, commitment, subcontract, lease, license or purchase order.

“ Designated Person ” has the meaning specified in Section 13.16(a).

“ Determination Date ” has the meaning specified in Section 3.4(b) .

“ DGCL ” has the meaning specified in the Recitals.

“ Disclosure Schedules ” has the meaning specified in the first sentence of Article IV .

“ Dissenting Share ” has the meaning specified in Section 3.1(a) .

“ EDGAR ” has the meaning specified in Section 5.20(a) .

“ Effective Time ” has the meaning specified in Section 2.3 .

“ Environmental Laws ” means any and all applicable foreign, federal, state or local laws, statutes, ordinances, rules or regulations relating to Hazardous Materials or the protection of the environment, as in effect on and as interpreted as of the date hereof.

“ ERISA ” means the Employee Retirement Income Security Act of 1974, as amended.

“ ERISA Affiliate ” shall mean any entity which is, or at any applicable time was, a member of (a) a controlled group of corporations (as defined in Section 414(b) of the Code), (b) a group of trades or businesses under common control (as defined in Section 414(c) of the Code), or (c) an affiliated service group (as defined under Section 414(m) of the Code or the regulations under Section 414(o) of the Code), any of which includes or included the Company, or otherwise would be treated as a single employer with the Company for purposes of Title IV of ERISA.

“ Estimated Adjustment Amount ” means the amount, if any, by which (a) the sum of the Estimated Closing Indebtedness Amount, plus the Estimated Excess Transaction Expenses exceeds (b) the sum of the Estimated Closing Date Net Working Capital plus the aggregate amount of any 2018 Company Bonus Payments actually paid prior to the Closing by the Company. For the avoidance of doubt the Estimated Adjustment Amount may not be a negative number.

“ Estimated Adjustment Shares ” means a number of Buyer Ordinary Shares (rounded to the nearest whole share) equal to the Estimated Adjustment Amount, divided by the Buyer Share Price.

“ Estimated Closing Cash Amount ” has the meaning specified in Section 3.3 .

“ Estimated Closing Date Net Working Capital ” has the meaning specified in Section 3.3 .

“ Estimated Closing Indebtedness Amount ” has the meaning specified in Section 3.3 .

“ Estimated Excess Transaction Expenses ” has the meaning specified in Section 3.3 .

“ Excess Transaction Expenses ” means any and all Transaction Expenses in excess of $6,618,159.

“ Exchange Act ” means the Securities Exchange Act of 1934, as amended.

“ Exchange Agent ” has the meaning specified in Section 3.2(a) .

“ Existing Representation ” has the meaning specified in Section 13.16(a) .

“ Exploitation ” means the act of making, having made, importing, using, selling, offering for sale, otherwise disposing of, researching, developing, registering, modifying, enhancing, improving, manufacturing, having manufactured, licensing, storing, formulating, optimizing, exporting, transporting, distributing, commercializing, promoting, marketing, having sold or otherwise having. disposed of.

“ FDA ” means the United States Food and Drug Administration.

“ FDCA ” means the United States Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

“ Final Merger Consideration ” has the meaning specified in Section 3.1(d) .

“ Final Surviving Corporation ” has the meaning specified in Section 2.1(d) .

“ Financial Statements ” has the meaning specified in Section 4.7 .

“ First Commercial Sale ” has the meaning specified in Section 3.10(b)(ii) .

“ First Merger ” has the meaning specified in Section 2.1(a) .

“ First Merger Constituent Corporations ” has the meaning specified in Section 2.1(a) .

“ First Step Surviving Corporation ” has the meaning specified in Section 2.1(b) .

“ Fundamental Representations ” means the representations and warranties of the Company in Sections 4.1 , 4.2 , 4.3 , 4.6 , 4.15 and 4.16 and the representations and warranties of the Buyer and Merger Sub in Sections 5.1 , 5.2 , 5.3 , 5.6 , 5.14 and 5.19 .

“ GAAP ” means United States generally accepted accounting principles, consistently applied.

“ Governmental Authority ” means any federal, state, provincial, municipal, local or foreign government, governmental authority, regulatory or administrative agency, governmental commission, department, board, bureau, agency, instrumentality, court or tribunal.

“ Governmental Order ” means any order, judgment, injunction, decree, writ, stipulation, determination or award, in each case, entered by or with any Governmental Authority.

“ Grant Date ” has the meaning specified in Section 4.6(d) .

“ Hazardous Material ” means any substance, material or waste that is listed, classified or regulated by a Governmental Authority as a “toxic substance,” “hazardous substance” or “hazardous material” or words of similar meaning and regulatory effect.

“ Holdback Issuance Date ” has the meaning specified in Section 11.8 .

“ Holdback Shares ” means that number of Buyer Ordinary Shares (rounded down to the nearest whole share) equal to 10% of the number of Base Shares.

“ Indebtedness ” of any Person as of any date means (i) all indebtedness or other obligation of such Person and its consolidated Subsidiaries for borrowed money, together with accrued and unpaid interest, fees and charges thereon and in respect thereof as of such date, (ii) all capitalized lease obligations of such Person and its consolidated Subsidiaries as of such date, (iii) the face amount of all letters of credit issued for the account of such Person as of such date, (iv) all guarantees and similar obligations of such Person as of such date, (v) all accrued interest, fees and charges in respect of any indebtedness as of such date and prepayment interest, fees, penalties, premiums and associated costs and expenses, (vi) all bankers acceptances and overdrafts as of such date, and (vii) obligations of such Person for any deferred purchase price of property or other assets (including earnout, milestone and similar obligations), except to the extent described on Schedule 1.1(a) ; provided , however , that Indebtedness shall not include (x) undrawn letters of credit and reimbursement obligations in respect of undrawn letters of credit or (y) obligations of such Person for any deferred purchase price of property or other assets (including earnout, milestone and similar obligations) described on Schedule 1.1(a) .

“ Indemnified Party ” has the meaning specified in Section 11.3(a) .

“ Indemnified Persons ” has the meaning specified in Section 7.1 .

“ Indemnitor ” means the party required to provide indemnification pursuant to Section 11.2 ; provided , however , that solely for the purposes of Sections 11.3 and 11.4 , the Stockholder Representative shall be considered the Indemnitor with respect to claims for indemnification pursuant to Section 11.2(a) (it being understood that such status as an Indemnitor is solely for the purpose of providing the Stockholder Representative with the right (i) to control the defense and settlement of any Action giving rise to a claim for indemnification pursuant to Section 11.2(a) and (ii) to engage in discussions, negotiations, and other dispute resolution with the applicable Indemnified Party regarding the claim for indemnification, and such status shall not obligate the Stockholder Representative, in such capacity, to provide any indemnification or otherwise impose any liability on the Stockholder Representative).

“ Independent Auditor ” has the meaning specified in Section 3.4(b) .

“ Information Statement ” has the meaning specified in Section 6.3 .

“ Intellectual Property ” means any of the following: (i) patents and patent applications (including provisional patent applications) and other governmental grants for the protection of inventions, including any substitutions, divisionals, continuations, continuations-in-

part, reissues, renewals, registrations, re-examinations, extensions, supplementary protection certificates and the like (collectively, “ Patent Rights ”); (ii) registered and unregistered trademarks, service marks and trade names, pending trademark and service mark registration applications, and intent-to-use registrations or similar reservations of marks, and all goodwill in the foregoing; (iii) registered and unregistered copyrights, moral rights of authors and applications for registration of copyright; (iv) internet domain names; and (v) trade secrets, inventions, invention disclosures, data, technology, processes and know-how.

“ Intended Tax Treatment ” has the meaning specified in Section 8.4(a) .

“ Interim Financial Statements ” has the meaning specified in Section 4.7 .

“ Ireland ” means the Republic of Ireland, and references to “Irish” shall be construed accordingly.

“ IRS ” means the United States Internal Revenue Service.

“ Law ” means any statute, law, ordinance, rule, regulation, decision, permit, authorization or Governmental Order, in each case, of any Governmental Authority and the common law.

“ Leased Real Property ” means all real property leased by the Company.

“ Lien ” means any mortgage, deed of trust, pledge, hypothecation, encumbrance, security interest or other lien of any kind.

“ Losses ” means any and all actual losses, damages, liabilities, fines, penalties, fees, costs or expenses.

“ Majority Holders ” has the meaning specified in Section 12.1 .

“ Material Adverse Effect ” means, (i) with respect to the Company, any event, occurrence, fact, condition or change that, individually or in the aggregate, has had or would reasonably be expected to have a material adverse effect on (x) the business, assets, liabilities, results of operations or financial condition of the Company, taken as a whole; provided , however , that, for purposes of this clause (x), in no event will any of the following (or the effect of any of the following), alone or in combination, be deemed to constitute, or be taken into account in determining whether there has been or will be, a “Material Adverse Effect” on or in respect of the Company, in each case to the extent first arising after the date hereof: (A) any change in Law, regulatory policies, accounting standards or principles (including GAAP) or any guidance relating thereto or interpretation thereof, (B) any change in interest rates or economic, political, business or financial market conditions generally (including any changes in credit, financial, commodities, securities or banking markets), (C) any change generally affecting any of the industries in which the Company operates or the economy as a whole, (D) the announcement of the execution of this Agreement, including losses or threatened losses of employees, customers, vendors, suppliers, contract manufacturers, distributors or others having relationships with the Company, (E) compliance with the terms of, or the taking of any action required by, this Agreement, or otherwise taken with the consent of Buyer, (F) any natural disaster, (G) any acts of terrorism, sabotage, war,

the outbreak or escalation of hostilities, weather conditions, change in geopolitical conditions or other force majeure events, or (H) any failure of the Company to meet any projections or forecasts, provided that this clause (H) shall not prevent a determination that any change or effect underlying such failure to meet projections or forecasts has resulted in a Material Adverse Effect (to the extent such change or effect is not otherwise excluded from this definition of Material Adverse Effect); except, in the case of clauses (B), (C), (F) and (G) above, to the extent that any such change, condition, event or effect has a materially disproportionate and adverse effect on the business of the Company relative to other businesses in the industries in which the Company operates or (y) on the ability of the Company to, in a reasonably timely manner, consummate the transactions contemplated by or to perform its material obligations under this Agreement; and (ii) with respect to Buyer or Merger Sub, any event, occurrence, fact, condition or change that has a material adverse effect on the ability of Buyer or Merger Sub to, in a reasonably timely manner, consummate the transactions contemplated by or to perform its material obligations under this Agreement.

“ Merger ” has the meaning specified in the recitals hereto.

“ Merger Consent ” has the meaning specified in Section 8.2 .

“ Merger Sub I ” has the meaning specified in the preamble hereto.

“ Merger Sub II ” has the meaning specified in the preamble hereto.

“ Merger Subs ” has the meaning specified in the preamble hereto.

“ Milestone Acceleration or Continuation Event ” has the meaning specified in Section 3.10(f) .

“ Milestone Payment ” has the meaning specified in Section 3.10(a) .

“ Milestone Payment Amount ” has the meaning specified in Section 3.10(b)(ii) .

“ Milestone Period ” has the meaning specified in Section 3.10(b)(iv) .

“ Milestone Reasonable Efforts ” has the meaning specified in Section 3.10(e) .

“ Milestone Share Price ” has the meaning specified in Section 3.10(g) .

“ Milestone Share Price Measurement Period ” has the meaning specified in Section 3.10(g) .

“ Milestones ” means the Approval Milestone and the Net Sales Milestones.

“ NDA ” means a New Drug Application or supplement to a New Drug Application as defined under the FDCA and 21 C.F.R. Part 314.

“ Net Sales ” has the meaning specified in Section 3.10(b)(iv) .

“ Net Sales 1 Milestone ” has the meaning specified in Section 3.10(a)(ii) .

“ Net Sales 2 Milestone ” has the meaning specified in Section 3.10(a)(iii) .

“ Net Sales 3 Milestone ” has the meaning specified in Section 3.10(a)(iv) .

“ Net Sales Milestone ” means the Net Sales 1 Milestone, the Net Sales 2 Milestone or the Net Sales 3 Milestone.

“ Net Working Capital ” as of any date means (i) the aggregate amount of the current assets of the Company within the categories specified in Schedule 1.1(b) as of such date, minus (ii) the aggregate amount of the current liabilities of the Company within the categories specified in Schedule 1.1(c) as of such date, in each case, as calculated in accordance with Section 3.4(a) .

“ Option Consideration ” has the meaning specified in Section 3.1(g) .

“ Outside Date ” has the meaning specified in Section 10.1(b)(ii) .

“ Patent Rights ” has the meaning specified in the definition of Intellectual Property.

“ Payment Spreadsheet ” has the meaning specified in Section 3.1(e) .

“ Pending Claim ” has the meaning specified in Section 11.8 .

“ Permitted Liens ” means (i) mechanics, materialmen’s and similar Liens with respect to any amounts not yet due and payable or which are being contested in good faith through (if then appropriate) appropriate proceedings, (ii) Liens for Taxes not yet due and payable or which are being contested in good faith through appropriate proceedings and for which adequate reserves are maintained in accordance with GAAP, (iii) Liens on real property (including easements, covenants, rights of way and similar restrictions of record) that (A) are matters of record, (B) would be disclosed by a current, accurate survey or physical inspection of such real property, or (C) do not materially interfere with the present uses or value of such real property, (iv) to the extent terminated in connection with the payment of the Closing Indebtedness Payoff Amount pursuant to Section 3.2(d) , Liens securing payment, or any other obligations, of the Company with respect to such Indebtedness, (v) Liens constituting a lease, sublease or occupancy agreement that gives any third party any right to occupy any real property, and (vi) Liens described on Schedule 1.1(d) .

“ Person ” means any individual, firm, corporation, partnership, limited liability company, incorporated or unincorporated association, joint venture, joint stock company, governmental agency or instrumentality or other entity of any kind.

“ Post-Closing Matter ” has the meaning specified in Section 13.16(a) .

“ Post-Closing Representation ” has the meaning specified in Section 13.16(a) .

“ Pre-Closing Designated Person ” has the meaning specified in Section 13.16(b) .

“ Pre-Closing Holders ” means all Persons who hold one or more Shares (including Shares subject to Company Restricted Stock Awards), Company Options or the Company Warrant immediately prior to the Effective Time.

“ Pre-Closing Privileges ” has the meaning specified in Section 13.16(b) .

“ Pre-Closing Tax Period ” means any Tax period ending on or before the Closing Date and the portion of any Straddle Period ending on and including the Closing Date.

“ Prior Company Counsel ” has the meaning specified in Section 13.16(a) .

“ Property Taxes ” means all real property Taxes, personal property Taxes and similar ad valorem Taxes.

“ Pro Rata Share ” means, with respect to any Pre-Closing Holder, the quotient (expressed as a percentage and calculated to four decimal points (e.g., 5.4321%)) obtained by dividing, as of any point in time, (a) the portion of the Final Merger Consideration then-paid to such Person for all shares of Company Capital Stock, Company Options and Company Warrants held by such Person by (b) the aggregate Final Merger Consideration then-paid, with such amount to be recalculated on each relevant date in accordance with the Payment Spreadsheet.

“ Public Offering ” has the meaning specified in Section 6.2 .

“ Qualified Holder ” means each holder of Company Capital Stock that reasonably demonstrates prior to the Closing that such holder (a) is an Accredited Investor or (b) either alone or with such holder’s “purchaser representative(s)” within the meaning of Rule 501(i) of Regulation D promulgated under the Securities Act, has such knowledge and experience in financial and business matters that such holder is capable of evaluating the merits and risks of the prospective investment in Buyer Ordinary Shares contemplated by this Agreement.

“ Registrable Securities ” has the meaning specified in Section 7.5(a) .

“ Registration Statement ” has the meaning specified in Section 7.5(a) .

“ Remedies Exception ” has the meaning specified in Section 4.3 .

“ Sarbanes-Oxley Act ” has the meaning specified in Section 5.20(a) .

“ Schedule ” has the meaning specified in the first sentence of Article IV .

“ SEC ” means the United States Securities and Exchange Commission.

“ Second Certificate of Merger ” has the meaning specified in Section 2.1(c) .

“ Second Effective Time ” has the meaning specified in Section 2.3 .

“ Second Merger ” has the meaning specified in the recitals.

“ Second Merger Constituent Corporations ” has the meaning specified in Section 2.1(c) .

“ Securities Act ” means the Securities Act of 1933, as amended.

“ Seller Indemnified Parties ” has the meaning specified in Section 11.2(b) .

“ Share Cap ” has the meaning specified in Section 3.1(d) .

“ Shareholder Approval ” means such approval as may be required by Irish Law or the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the shareholders of Buyer with respect to the issuance of Buyer Ordinary Shares in connection with any Milestone Payment in excess of 19.9% of the issued and outstanding Buyer Ordinary Shares on the Closing Date.

“ Shares ” has the meaning specified in Section 3.1(a) .

“ Stockholder Representative ” has the meaning specified in Section 12.1 .

“ Stockholder Representative Expense Fund ” has the meaning specified in Section 3.5 .

“ Stockholder Representative Expenses ” has the meaning specified in Section 3.5 .

“ Straddle Period ” means any Tax period that begins on or before, and ends after, the Closing Date.

“ Subsidiary ” means, with respect to a Person, a corporation or other entity of which more than 50% of the voting power of the equity securities or equity interests is owned, directly or indirectly, by such Person.

“ Successor Entity ” has the meaning specified in Section 3.10(f) .

“ Support Agreement ” has the meaning specified in the recitals hereto.

“ Surrender Agreement ” has the meaning specified in Section 3.1(g) .

“ Survival Expiration Date ” has the meaning specified in Section 11.1 .

“ Tax Authority ” means any Governmental Authority having or purporting to exercise jurisdiction with respect to any Tax.

“ Tax Contest ” has the meaning specified in Section 8.4(f) .

“ Tax Returns ” means any return, declaration, report, statement, information statement or other document filed or required to be filed with respect to Taxes, including any claims for refunds of Taxes and any amendments or supplements of any of the foregoing, filed or required to be filed with any Tax Authority.

“ Taxes ” means all federal, state, local, foreign or other tax, charge, fee, duty, contribution, levy or other similar assessment or liability, including all income, gross receipts, corporation, net worth, capital gains, insurance, business license, business organization, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, environmental, customs duties, capital stock, ad valorem, value added, inventory, franchise,

profits, withholding, social security (or similar), national insurance, workers compensation, unemployment, disability, real property, personal property, sales, use, lease, service, service use, transfer, registration, documentary, recapture, recording, alternative or add-on minimum, or estimated tax, and including any interest, fine, penalty or addition thereto, whether disputed or not.

“ Third-Party Claim ” has the meaning specified in Section 11.3(a) .

“ Transaction Expenses ” means (without duplication) any and all (a) legal, accounting, investment banking, consulting and other out-of-pocket fees, costs or expenses incurred by or on behalf of the Company or any of its Subsidiaries in connection with the transactions contemplated by this Agreement, (b) all Change in Control Payments and (c) the Stockholder Representative Expense Fund, solely to the extent any of the foregoing obligations has not been paid by the Company prior to the Closing, with the exception of any 2018 Company Bonus Payments actually paid prior to the Closing by the Company, which shall be considered to be Transaction Expenses despite having been paid prior to the Closing.

“ Transfer Taxes ” means any transfer, sales, use, stamp, documentary, registration, conveyance, recording, value-added or other similar Tax or governmental fee (and any interest, penalty, or addition with respect thereto) payable as a result of the consummation of the Merger.

“ Treasury Regulations ” means the United States Treasury regulations promulgated under the Code.

“ True-up Amount ” has the meaning specified in Section 3.4(c) .

“ Written Consent ” shall mean a written consent of the stockholders of the Company in the form attached hereto as Annex E .

“ Year-End Financial Statements ” has the meaning specified in Section 4.7 .

1.2 Construction .

(a) Unless the context of this Agreement otherwise requires, (i) words of any gender include each other gender; (ii) words using the singular or plural number also include the plural or singular number, respectively; (iii) the terms “hereof,” “herein,” “hereby,” “hereto” and derivative or similar words refer to this entire Agreement; (iv) the terms “Article,” “Section,” “Schedule” or “Annex” refer to the specified Article or Section of, or Schedule or Annex to, this Agreement; (v) the word “including” shall mean “including, without limitation,” and (vi) the word “or” shall be disjunctive but not exclusive.

(b) Unless the context of this Agreement otherwise requires, references to agreements and other documents shall be deemed to include all subsequent amendments and other modifications thereto.

(c) Unless the context of this Agreement otherwise requires, references to statutes shall include all rules and regulations promulgated thereunder.

(d) The language used in this Agreement shall be deemed to be the language chosen jointly by the parties to express their mutual intent and no rule of strict construction shall be applied against any party.

(e) Whenever this Agreement refers to a number of days, such number shall refer to calendar days unless Business Days are specified.

(f) The phrase “to the extent” shall mean the degree to which a subject or other thing extends, and such phrase shall not mean simply “if.”

(g) All accounting terms used herein and not expressly defined herein shall have the meanings given to them under GAAP.

(h) All amounts payable pursuant to this Agreement shall be paid in U.S. dollars, and all references to “$” or “dollars” shall mean the lawful currency of the United States of America.

(i) When reference is made in this Agreement to information that has been “made available” to the Buyer, that shall consist of only the information that was contained in the Company’s electronic data room no later than 5:00 p.m., Eastern time, on the Business Day prior to the date of this Agreement.

1.3 Knowledge . As used herein, the phrases “to the knowledge” of any party or to such party’s “knowledge” shall mean the knowledge of, in the case of (a) the Company, Theodore R. Schroeder, Richard G. Vincent, Evelyn Ellis-Grosse, Kevin P. Finney and Krissy Haeckl, in each case after reasonable inquiry of such individual’s direct reports, and (b) Buyer and Merger Sub, the Buyer’s Chief Executive Officer, Chief Financial Officer, Chief Scientific Officer and Chief Medical Officer, in each case after reasonable inquiry of such individual’s direct reports.

ARTICLE II.
THE MERGER; CLOSING

2.1 First Merger and Second Merger .

(a) Upon the terms and subject to the conditions set forth in this Agreement, and in accordance with the applicable provisions of the DGCL, Buyer, Merger Sub I and the Company (Merger Sub I and the Company sometimes being referred to herein as the “ First Merger Constituent Corporations ”) shall cause Merger Sub I to be merged with and into the Company effective as of the Effective Time, with the Company being the surviving corporation (the “ First Merger ”). The First Merger shall be consummated at the Effective Time in accordance with this Agreement and evidenced by a certificate of merger relating to the First Merger in substantially the form of Annex B-1 (the “ Certificate of Merger ”).

(b) Upon consummation of the First Merger, the separate corporate existence of Merger Sub I shall cease and the Company, as the surviving corporation of the First Merger (hereinafter referred to for the periods at and after the Effective Time as the “ First

Step Surviving Corporation ”), shall continue its corporate existence under the DGCL as a wholly owned subsidiary of Buyer.

(c) Upon the terms and subject to the conditions set forth in this Agreement, and in accordance with the applicable provisions of the DGCL, Buyer, Merger Sub II and the First Step Surviving Corporation (Merger Sub II and the First Step Surviving Corporation sometimes being referred to herein as the “ Second Merger Constituent Corporations ”) shall cause the Second Merger to be consummated. The Second Merger shall be consummated at the Second Effective Time in accordance with this Agreement and evidenced by a certificate of merger relating to the Second Merger in substantially the form of Annex B-2 (the “ Second Certificate of Merger ”).

(d) Upon consummation of the Second Merger, the separate corporate existence of the First Step Surviving Corporation shall cease and Merger Sub II, as the surviving corporation of the Second Merger (hereinafter referred to for the periods at and after the Second Effective Time as the “ Final Surviving Corporation ”), shall continue its corporate existence under the DGCL as a wholly owned subsidiary of Buyer.

2.2 Effects of the Merger .

(a) At and after the Effective Time, the effect of the First Merger shall be as provided in this Agreement and the applicable provisions of the DGCL. Without limiting the foregoing, the First Step Surviving Corporation shall thereupon and thereafter possess all of the rights, property, privileges, powers and franchises, of a public as well as a private nature, of the First Merger Constituent Corporations, and shall become subject to all the restrictions, disabilities and duties of each of the First Merger Constituent Corporations.

(b) At and after the Second Effective Time, the effect of the Second Merger shall be as provided in this Agreement and the applicable provisions of the DGCL. Without limiting the foregoing, the Final Surviving Corporation shall thereupon and thereafter possess all of the rights, property, privileges, powers and franchises, of a public as well as a private nature, of the Second Merger Constituent Corporations, and shall become subject to all the restrictions, disabilities and duties of each of the Second Merger Constituent Corporations.

2.3 Closing; Effective Time and Second Effective Time . Subject to the terms and conditions of this Agreement, the closing of the First Merger (the “ Closing ”) shall take place at the offices of Latham & Watkins LLP, 12670 High Bluff Dr., San Diego, California 92130, at 10:00 a.m. (Pacific Time) as soon as practicable on or after the execution and delivery of this Agreement, but in any event no later than the date which is two (2) Business Days after the date on which all conditions set forth in Article IX shall have been satisfied or waived (other than those conditions that by their nature are to be satisfied at the Closing, but subject to the satisfaction or waiver of such conditions) or such other time and place as Buyer and the Company may mutually agree in writing. The date on which the Closing actually occurs is referred to in this Agreement as the “ Closing Date .” The parties hereto mutually agree that the Closing may take place by the electronic exchange of executed counterpart documents and the electronic transfer of funds. Subject to the satisfaction or waiver of all of the conditions set forth in Article IX , and provided that this Agreement has not theretofore been terminated pursuant to its terms, Buyer, Merger Sub I and the Company shall

cause the Certificate of Merger to be executed, acknowledged and filed with the Secretary of State of the State of Delaware as provided in Section 251 of the DGCL. The First Merger shall become effective at the time when the Certificate of Merger has been duly filed with the Secretary of State of the State of Delaware or at such later time as may be agreed by Buyer and the Company in writing and specified in the Certificate of Merger (the “ Effective Time ”). Promptly following the Effective Time, but in no event later than two (2) Business Days thereafter, Buyer, the First Step Surviving Corporation and Merger Sub II shall cause the Second Certificate of Merger to be filed with the Secretary of State of Delaware (the “ Second Effective Time ”).

2.4 Certificate of Incorporation and Bylaws .

(a) At the Effective Time, the Company Charter shall be amended as of the Effective Time to read in its entirety as the certificate of incorporation of Merger Sub reads as in effect immediately prior to the Effective Time, provided , that such certificate of incorporation shall reflect, as of the Effective Time, “Zavante Therapeutics, Inc.” as the name of the First Step Surviving Corporation, and, as so amended, shall become the certificate of incorporation of the First Step Surviving Corporation until thereafter amended in accordance with the applicable provisions of the DGCL and such certificate of incorporation; provided that any such amendment shall be subject to the provisions of Section 7.1 .

(b) The parties hereto shall take all actions necessary so that the Company Bylaws shall, from and after the Effective Time, be amended in their entirety in the form of the bylaws of Merger Sub as in effect immediately prior to the Effective Time (except that (i) in any event such amended bylaws must comply with Section 7.1 and (ii) all references to the name of Merger Sub shall be changed to refer to the name of the Company), until thereafter amended in accordance with the applicable provisions of the DGCL, the certificate of incorporation of the First Step Surviving Corporation and such bylaws; provided that any such amendment shall be subject to the provisions of Section 7.1 .

(c) At the Second Effective Time, the certificate of incorporation of the First Step Surviving Corporation shall be amended as of the Second Effective Time to read in its entirety as the certificate of incorporation of Merger Sub II reads as in effect immediately prior to the Second Effective Time, provided , that such certificate of incorporation shall reflect, as of the Second Effective Time, “Zavante Therapeutics, Inc.” as the name of the Final Surviving Corporation, and, as so amended, shall become the certificate of incorporation of the Final Surviving Corporation until thereafter amended in accordance with the applicable provisions of the DGCL and such certificate of incorporation; provided that any such amendment shall be subject to the provisions of Section 7.1 .

(d) The parties hereto shall take all actions necessary so that the bylaws of the Final Surviving Corporation shall, from and after the Second Effective Time, be amended in their entirety in the form of the bylaws of Merger Sub II as in effect immediately prior to the Second Effective Time (except that (i) in any event such amended bylaws must comply with Section 7.1 and (ii) all references to the name of Merger Sub II shall be changed to refer to the name of the Company), until thereafter amended in accordance with the applicable provisions of the DGCL, the certificate of incorporation of the Final

Surviving Corporation and such bylaws; provided that any such amendment shall be subject to the provisions of Section 7.1.

2.5 Directors and Officers .

(a) The directors of Merger Sub I immediately prior to the Effective Time shall be the directors of the First Step Surviving Corporation immediately after the Effective Time, each to hold office in accordance with the certificate of incorporation and bylaws of the First Step Surviving Corporation until their respective successors are duly elected or appointed and qualified or until their earlier death, resignation or removal in accordance with the certificate of incorporation and bylaws of the First Step Surviving Corporation.

(b) The officers of Merger Sub I immediately prior to the Effective Time shall be the officers of the Final Surviving Corporation immediately after the Effective Time, each to hold office in accordance with the certificate of incorporation and bylaws of the Final Surviving Corporation until their respective successors are duly appointed or until their earlier death, resignation or removal in accordance with the certificate of incorporation and bylaws of the Final Surviving Corporation.

(c) The directors of Merger Sub II immediately prior to the Second Effective Time shall be the directors of the Final Surviving Corporation immediately after the Second Effective Time, each to hold office in accordance with the certificate of incorporation and bylaws of the Final Surviving Corporation until their respective successors are duly elected or appointed and qualified or until their earlier death, resignation or removal in accordance with the certificate of incorporation and bylaws of the Final Surviving Corporation.

(d) The officers of Merger Sub II immediately prior to the Second Effective Time shall be the officers of the Final Surviving Corporation immediately after the Second Effective Time, each to hold office in accordance with the certificate of incorporation and bylaws of the Final Surviving Corporation until their respective successors are duly appointed or until their earlier death, resignation or removal in accordance with the certificate of incorporation and bylaws of the Final Surviving Corporation.

ARTICLE III.
EFFECTS OF THE MERGER ON THE CAPITAL STOCK AND EQUITY AWARDS

3.1 Conversion of Company Shares; Treatment of Company Options; Treatment of Company Warrant .

(a) At the Effective Time, by virtue of the First Merger and without any further action on the part of any stockholder of the Company, Buyer or Merger Sub I, each share of Company Capital Stock held by Buyer, Merger Sub I or the Company in treasury or otherwise, shall be canceled and retired and shall cease to exist, and no consideration shall be delivered or receivable in exchange therefor (such shares, “ Cancelled Shares ”). At the Effective Time, by virtue of the First Merger and without any action on the part of any Company Stockholder (other than compliance with Section 3.2(b) by the

applicable holder), each share of Company Capital Stock (a “ Share ”) that is issued and outstanding immediately prior to the Effective Time (including Shares subject to Company Restricted Stock Awards), other than (A) Cancelled Shares and (B) shares (each, a “ Dissenting Share ”) of Company Capital Stock held by Persons who object to the First Merger and comply with the provisions of the DGCL concerning the rights of holders of Company Capital Stock to dissent from the First Merger and require appraisal of their shares of Company Capital Stock, shall thereupon be canceled and converted into and become the right to receive the applicable portion of the Final Merger Consideration as set forth on the Payment Spreadsheet.

(b) At the Effective Time, by virtue of the First Merger and without any action on the part of Buyer or Merger Sub I, each share of common stock, par value $0.001 per share, of Merger Sub I issued and outstanding immediately prior to the Effective Time shall be cancelled and, in exchange for the cancellation of such shares of Merger Sub I common stock and the funding of the Final Merger Consideration by Buyer, the First Step Surviving Corporation shall issue an equivalent number of shares of common stock, par value $0.001 per share, all of which shares shall be held by Buyer, and which shall constitute the only outstanding shares of common stock of the First Step Surviving Corporation immediately following the Effective Time.

(c) At the Second Effective Time, by virtue of the Second Merger and without any action on the part of Buyer or Merger Sub II, each share of common stock, par value $0.001 per share, of the First Step Surviving Corporation issued and outstanding immediately prior to the Second Effective Time shall be cancelled and, in exchange for the cancellation of such shares of First Step Surviving Corporation common stock, the Final Surviving Corporation shall issue an equivalent number of shares of common stock, par value $0.001 per share, all of which shares shall be held by Buyer, and which shall constitute the only outstanding shares of common stock of the Final Surviving Corporation immediately following the Second Effective Time.

(d) The “ Closing Merger Consideration ” shall mean a number of Buyer Ordinary Shares (rounded down to the nearest whole share) equal to (i) the Base Shares, minus (ii) the number of Estimated Adjustment Shares, if any, minus (iii) the Holdback Shares, if any; provided that in lieu of any Buyer Ordinary Shares otherwise issuable to any Cash-Out Holder as Closing Merger Consideration (following deduction of any applicable Holdback Shares) a cash amount equal to the number of such Buyer Ordinary Shares multiplied by the Buyer Share Price, less applicable tax withholding, shall be paid. The “ Final Merger Consideration ” shall consist of the Closing Merger Consideration plus (A) any Milestone Payment Amount paid pursuant to Section 3.10 , minus (B) the True-Up Amount, if any, plus (C) any amounts paid to the Pre-Closing Holders pursuant to Section 3.5 , plus (D) any amounts paid to the Pre-Closing Holders pursuant to Section 11.8 , provided that in lieu of any Buyer Ordinary Shares otherwise issuable in respect of Company Options or the Company Warrant or to any Cash-Out Holder as Final Merger Consideration a cash amount determined in accordance with the applicable section of this Agreement, less applicable tax withholding, shall be paid. Notwithstanding anything to the contrary herein, in no event shall Buyer issue (or have any obligation to issue) pursuant to, or in connection with the transactions contemplated

by, this Agreement a number of Buyer Ordinary Shares that exceeds nineteen and nine tenths percent (19.9%) of the total number of Buyer Ordinary Shares issued and outstanding immediately prior to the Closing or that would otherwise require approval of the shareholders of Buyer under applicable Law or stock exchange rules (the “ Share Cap ”) unless, prior to any issuance of Buyer Ordinary Shares in excess of the Share Cap, Buyer has obtained Shareholder Approval. For the avoidance of doubt, if Shareholder Approval has not been obtained, any such excess amounts of Closing Merger Consideration or Final Merger Consideration then due and payable to the Pre-Closing Holders shall be paid in cash.

(e) Not less than two (2) Business Days prior to the Closing Date, the Company shall deliver to the Exchange Agent and Buyer a spreadsheet (as it may be amended following the Closing in accordance with the terms of this Agreement, the “ Payment Spreadsheet ”), certified by an officer of the Company, that sets forth: (i) the portion of the Closing Merger Consideration (in Buyer Ordinary Shares) that each Pre-Closing Holder is entitled to receive (which amounts shall be calculated in accordance with the provisions of the Company Charter, as amended and in effect as of immediately prior to the Closing); (ii) the number of Buyer Ordinary Shares constituting Holdback Shares allocable to each Company Stockholder; (iii) the amounts and payees of any Closing Indebtedness; (iv) the amounts of any Transaction Expenses that remain unpaid as of immediately prior to the Closing and the payees to whom such amounts are owed; (v) wire instructions with respect to all amounts designated in such spreadsheet; (vi) the amount of the Stockholder Representative Expense Fund; (vii) the amount, in cash, payable to each Pre-Closing Holder for each Milestone Payment that becomes payable, if any, expressed as both as an amount and as a percentage, pursuant to Section 3.10 ; (viii) the amounts of any Transaction Expenses that become payable as a result of any Milestone Payment that is paid, if any, pursuant to Section 3.10, and the payees to whom such amounts are owed and (ix) each Pre-Closing Holder’s Pro Rata Share. From time to time following the Closing, the Payment Spreadsheet shall be amended by the Stockholder Representative, in order to make any necessary updates to the payment amounts to be received by, or the Pro Rata Shares of, the Pre-Closing Holders in accordance with the provisions of the Company Charter, as amended and in effect as of immediately prior to the Closing, after taking into account any and all portions of the Final Merger Consideration previously paid to each Pre-Closing Holder, including any Buyer Ordinary Shares (or cash in lieu thereof) that may be released to the Company Stockholders from the Holdback Shares and any cash amounts that may be released to the Pre-Closing Holders from the Stockholder Representative Expense Fund. The Buyer shall be entitled to rely conclusively on the Payment Spreadsheet as in effect from time to time.

(f) From and after the Effective Time, (i) holders of Certificates shall cease to have any rights as stockholders of the Company and (ii) the consideration paid pursuant to this Article III upon the surrender of Certificates in accordance with the terms hereof shall be deemed to have been paid in full satisfaction of all rights pertaining to the Shares, subject to the continuing rights of the Pre-Closing Holders under this Agreement. At the Effective Time, the transfer books of the Company shall be closed and no transfer of Shares shall be made thereafter.

(g) Immediately prior to the Effective Time, each unexpired and unexercised option to purchase shares of Company Common Stock (the “ Company Options ”) granted pursuant to the Company Equity Plan, whether or not then exercisable or vested, shall become fully vested and exercisable and will be cancelled and, in exchange therefor, each former holder of any such cancelled Company Option who has executed and returned to Buyer a Surrender Agreement in the form attached hereto as Annex F (“ Surrender Agreement ”) will be entitled to receive, in consideration of such cancelled Company Option and in full settlement therefor, a payment in cash in an amount equal to the applicable portion of the Final Merger Consideration as set forth on the Payment Spreadsheet (which, for the avoidance of doubt, nets out the applicable aggregate exercise price with respect to such Company Option) (the aggregate consideration to be paid to holders of Company Options at Closing, the “ Closing Option Consideration ,” and the aggregate consideration to be paid to holders of Company Options pursuant to this Agreement, including Section 3.10 , the “ Option Consideration ”), less applicable Tax withholding.

(h) Immediately prior to the Effective Time, each Company Restricted Stock Award shall become fully vested.

(i) Immediately prior to the Effective Time, the Company Warrant, in consideration for its surrender and cancellation, shall be converted into the right to receive ( provided that the holder of such Company Warrant has executed and returned to Buyer a Surrender Agreement) a payment in cash in an amount equal to the applicable portion of the Final Merger Consideration as set forth on the Payment Spreadsheet (which, for the avoidance of doubt, nets out the applicable aggregate exercise price with respect to such Company Warrant) (the aggregate consideration to be paid to the holder of the Company Warrant, the “ Warrant Consideration ”), less applicable Tax withholding. The Company Warrant, when so converted, shall no longer be outstanding and shall automatically be canceled and retired, and the holder of the Company Warrant shall cease to have any rights with respect thereto, except the right to receive the Warrant Consideration with respect to such Company Warrant.

(j) At or prior to the Effective Time, the Company, the Board of Directors of the Company and/or the Compensation Committee of the Board of Directors of the Company, as applicable, shall adopt any resolutions and take any actions which are necessary to effectuate the provisions of this Section 3.1 as it relates to Company Options, Company Restricted Stock Awards or the Company Warrant. The Company shall take all actions necessary to ensure that, from and after the Effective Time, the Final Surviving Corporation will be required to deliver the Option Consideration to former holders of Company Options.

(k) In the event of any share split, combination, reclassification, bonus issue of shares or similar capitalization change with respect to Buyer Ordinary Shares prior to Closing or before any Milestone Payment is made, or if a record date with respect to any of the foregoing is fixed, appropriate and proportionate adjustments shall be made to the Final Merger Consideration and the Payment Spreadsheet.

3.2 Closing Payments and Exchange of Certificates.

(a) At or immediately following the Effective Time on the Closing Date, in consideration of the First Merger being consummated, Buyer shall issue fully paid, and shall deliver to Computershare Trust Company, N.A., as exchange agent (or such other party as the Stockholder Representative shall subsequently designate and provide ten (10) days’ prior notice of such designation to Buyer, and that shall be reasonably acceptable to Buyer) (the “ Exchange Agent ”) the number of Buyer Ordinary Shares equal to the aggregate Closing Merger Consideration, as set forth on the Payment Spreadsheet, for distribution to the Pre-Closing Holders who have complied with Section 3.2(b) (other than holders of Company Options and the holder of the Company Warrant).

(b) After the Effective Time, each Pre-Closing Holder of an outstanding certificate or certificates for shares of Company Capital Stock (collectively, the “ Certificates ”), upon surrender of such Certificates and delivery of a letter of transmittal in the form attached hereto as Annex C (“ Letter of Transmittal ”) (which shall include, among other things, an executed consent to the releases and indemnification obligations and the appointment of the Stockholder Representative as contemplated by Article XI) to the Exchange Agent or Buyer, shall be entitled to receive from the Exchange Agent or Buyer in exchange therefor such number of Buyer Ordinary Shares (rounded down to the nearest whole share) equal to the portion of the Final Merger Consideration into which such holder’s Shares shall have been converted as a result of the First Merger; provided , that each Cash-Out Holder shall receive its applicable portion of the Final Merger Consideration in cash in accordance with Section 3.1; provided , further , that a number of Buyer Ordinary Shares (rounded down to the nearest whole share) equal to the portion of the Closing Merger Consideration equal to the Holdback Shares otherwise payable to each Company Stockholder, in the amounts set forth on the Payment Spreadsheet, shall be retained by Buyer to satisfy any amounts owed to Buyer pursuant to the Pre-Closing Holders’ indemnification obligations pursuant to Article XI . Pending such surrender and exchange of a Pre-Closing Holder’s Certificate(s), a holder’s Certificate(s), as applicable, shall be deemed for all purposes to evidence such holder’s right to receive the portion of the Final Merger Consideration into which such Shares shall have been converted as a result of the First Merger.

(c) On the first payroll date following the Effective Time that is at least three (3) Business Days following the Effective Time, in consideration for the cancellation of the Company Options, Buyer or the Final Surviving Corporation shall deliver to each former holder of Company Options that has delivered a Surrender Agreement to Buyer, through Buyer’s or the Final Surviving Corporation’s payroll system and subject to applicable Tax withholding, cash in an amount representing the Closing Option Consideration, if any, to be paid to such former holder of Company Options pursuant to Section 3.1 and as set forth on the Payment Spreadsheet. No interest will be paid or accrued upon any Option Consideration.

(d) After the Effective Time, upon delivery to Buyer of a Surrender Agreement and, as applicable, a completed Form W-9 or Form W-8BEN, Buyer or the Final Surviving

Corporation shall deliver to the former holder of the Company Warrant, subject to applicable Tax withholding, cash in an amount representing the Warrant Consideration, if any, to be paid to such former holder of the Company Warrant pursuant to Section 3.1 and as set forth on the Payment Spreadsheet. No interest will be paid or accrued upon any Warrant Consideration.

(e) Prior to the Effective Time, the Company shall (only if requested in writing by the Buyer at least two Business Days prior to the Closing Date) pay in full the Indebtedness set forth on Schedule 3.2(e) and provide to Buyer customary payoff letters and releases with respect thereto. At the Effective Time, Buyer shall, or shall cause an Affiliate to, pay, in cash, to the intended beneficiaries (as identified on the Payment Spreadsheet), (i) the amount of all Closing Indebtedness that by its terms becomes due and payable as of the Effective Time (the “ Closing Indebtedness Payoff Amount ”) to the extent that, prior to the Effective Time, the Company has delivered customary payoff letters and releases with respect thereto, and (ii) the Transaction Expenses that remain unpaid as of immediately prior to the Closing. Prior to the Effective Time, the Company shall seek (at Buyer’s sole cost and expense) such amendments or modifications to, or consents or waivers under, the terms of any agreements or instruments governing the Indebtedness of the Company as Buyer may reasonably request in connection with the transactions contemplated by this Agreement (it being understood that the Company need not incur any unreimbursed expense or liability prior to the Effective Time in connection therewith).

(f) In the event of any share split, combination, reclassification, bonus issue of shares or similar capitalization change with respect to Buyer Ordinary Shares prior to the Holdback Delivery Date, or if a record date with respect to any of the foregoing is fixed, appropriate and proportionate adjustments shall be made to the Buyer Ordinary Shares comprising the Holdback Shares.

3.3 Estimated Adjustment Amount . Not less than three (3) Business Days prior to the Closing Date and in no event more than ten (10) Business Days prior to the Closing Date, the Company shall deliver to Buyer (a) its reasonable and good faith estimated Closing Balance Sheet (prepared in accordance with Section 3.4(a) ) and (b) a written statement setting forth (i) its good faith estimate of (A) Closing Date Net Working Capital (“ Estimated Closing Date Net Working Capital ”), (B) the Closing Cash Amount (the “ Estimated Closing Cash Amount ”), (C) the Closing Indebtedness Amount (the “ Estimated Closing Indebtedness Amount ”), and (D) the Excess Transaction Expenses (the “ Estimated Excess Transaction Expenses ”), and the components and calculations thereof in reasonable detail, by reference to the foregoing Closing Balance Sheet and supporting documentation and (ii) the Company’s calculation of the Estimated Adjustment Amount.

3.4 Adjustment Amount .

(a) As soon as reasonably practicable following the Closing Date, and in any event within seventy-five (75) calendar days thereof, Buyer shall prepare and deliver to the Stockholder Representative (i) the Closing Balance Sheet and (ii) calculations of (w) Net Working Capital (“ Closing Date Net Working Capital ”) calculated as of immediately

prior to the Effective Time consistent (except as provided in this Section 3.4(a) ) with the Closing Balance Sheet, (x) the Closing Cash Amount, (y) the Closing Indebtedness Amount, and (z) the Excess Transaction Expenses. The Closing Balance Sheet shall be prepared in accordance with GAAP applied in a manner consistent with the principles applied in connection with the preparation of the most recent audited balance sheet included in the Financial Statements. Following the Closing and until the final determination of the Adjustment Amount, Buyer shall, upon reasonable advanced written notice in a manner that does not unreasonably interfere with the business or operations of the Buyer, provide the Stockholder Representative and its representatives access during normal business hours to the records, properties, personnel and (subject to the execution of customary work paper access letters if requested) auditors of the Company solely relating to the preparation of the Closing Balance Sheet and shall cause the personnel of the Company to cooperate with the Stockholder Representative in connection with its review of the Closing Balance Sheet.

(b) If the Stockholder Representative shall disagree with such calculation of Closing Date Net Working Capital, Closing Cash Amount, Closing Indebtedness Amount or Excess Transaction Expenses, it shall notify Buyer of such disagreement in writing, setting forth in reasonable detail the particulars of such disagreement, within thirty (30) days after its receipt of the Closing Balance Sheet. In the event that the Stockholder Representative does not provide a notice of disagreement within such thirty (30)-day period, the Stockholder Representative and Buyer shall be deemed to have agreed to the Closing Balance Sheet and the calculations of Closing Date Net Working Capital, Closing Cash Amount, Closing Indebtedness Amount and Excess Transaction Expenses delivered by Buyer, which shall be final, binding and conclusive for all purposes hereunder. In the event any notice of disagreement is timely provided, Buyer and the Stockholder Representative shall use commercially reasonable efforts for a period of fifteen (15) days (or such longer period as they may mutually agree) to resolve any disagreements with respect to the calculations of Closing Date Net Working Capital, Closing Cash Amount, Closing Indebtedness Amount and Excess Transaction Expenses. If, at the end of such period, they are unable to resolve such disagreements, then any such remaining disagreements shall be resolved by KPMG LLP or such other independent accounting or financial consulting firm of recognized national standing as may be mutually selected by Buyer and the Stockholder Representative (such firm, the “ Independent Auditor ”). Each of Buyer and the Stockholder Representative shall promptly provide their respective assertions regarding Closing Date Net Working Capital, Closing Cash Amount, Closing Indebtedness Amount or Excess Transaction Expenses, as applicable, and, to the extent relevant thereto, the Closing Balance Sheet in writing to the Independent Auditor and to each other. The Independent Auditor shall be instructed to render its determination with respect to such disagreements as soon as reasonably possible (which the parties hereto agree should not be later than sixty (60) days following the day on which the disagreement is referred to the Independent Auditor). The Independent Auditor shall base its determination solely on (i) the written submissions of the parties and shall not conduct an independent investigation and (ii) the extent (if any) to which Closing Date Net Working Capital, Closing Cash Amount, Closing Indebtedness Amount or Excess Transaction Expenses requires adjustment (only with respect to the remaining disagreements submitted to the Independent Auditor) in

order to be determined in accordance with Section 3.4(a) (including the definitions of the defined terms used in Section 3.4(a) ). In resolving any disputed item, the Independent Auditor may not assign a value to any item greater than the greatest value for such item claimed by either party or less than the smallest value for such item claimed by either party. The determination of the Independent Auditor shall be final, conclusive and binding on the parties. The date on which Closing Date Net Working Capital, Closing Cash Amount, Closing Indebtedness Amount and Excess Transaction Expenses is finally determined in accordance with this Section 3.4(b) is hereinafter referred to as the “ Determination Date .” All fees and expenses of the Independent Auditor relating to the work, if any, to be performed by the Independent Auditor hereunder shall be borne pro rata as between Buyer, on the one hand, and the Stockholder Representative as a Stockholder Representative Expense, on the other hand, in proportion to the allocation of the dollar value of the amounts in dispute as between Buyer and the Stockholder Representative (set forth in the written submissions to the Independent Auditor) made by the Independent Auditor such that the party prevailing on the greater dollar value of such disputes pays the lesser proportion of the fees and expenses. For example, if the Stockholder Representative challenges items underlying the calculation of Closing Date Net Working Capital in the net amount of $1,000,000, and the Independent Auditor determines that Buyer has a valid claim for $400,000 of the $1,000,000, Buyer shall bear 60% of the fees and expenses of the Independent Auditor and the Stockholder Representative shall bear the remaining 40% of the fees and expenses of the Independent Auditor as a Stockholder Representative Expense.

(c) The “ Adjustment Amount ” means the amount, if any, by which (a) the sum of the Closing Indebtedness Amount, plus the Excess Transaction Expenses exceeds (b) the Closing Date Net Working Capital. For the avoidance of doubt, the Adjustment Amount may not be a negative number. The “ True-up Amount ” means the positive amount, if any, by which the Adjustment Amount exceeds the Estimated Adjustment Amount. For the avoidance of doubt the True-up Amount may not be a negative number.

(d) If the True-up Amount is a positive number, then Buyer shall reduce the number of Holdback Shares by a number of Buyer Ordinary Shares (rounded down to the nearest whole share) equal to (A) the True-up Amount divided by (B) the Buyer Share Price. In no event shall the Stockholder Representative or any Pre-Closing Holder have any liability under this Section 3.4 in excess of such Pre-Closing Holder’s allocable share of the Holdback Shares.

(e) All amounts paid pursuant to this Section 3.4 shall be treated by the parties hereto for all Tax purposes as adjustments to the Closing Merger Consideration to the greatest extent permitted by applicable Law, and shall be reported as such by the parties hereto on their Tax Returns.

3.5 Stockholder Representative Expenses . On or immediately prior to the Closing Date, the Company shall pay an amount in cash equal to $200,000 (the “ Stockholder Representative Expense Fund ”), in accordance with the Payment Spreadsheet, by wire transfer of immediately available funds to an account designated by the Stockholder Representative for the purpose of

paying the fees and expenses incurred, or that may in the future be incurred, by the Stockholder Representative on behalf of the Company and the Pre-Closing Holders in connection with the preparation, negotiation and execution of this Agreement or the consummation of the transactions contemplated hereby or otherwise in its capacity as the Stockholder Representative (the “ Stockholder Representative Expenses ”). No amount shall be included on the Closing Balance Sheet with respect to liabilities for the Stockholder Representative Expenses. The Stockholder Representative Expense Fund shall be used (a) for the purposes of paying directly or reimbursing the Stockholder Representative for any Stockholder Representative Expenses incurred pursuant to this Agreement, or (b) as otherwise determined by the Stockholder Representative. The Stockholder Representative is not providing any investment supervision, recommendations or advice and shall have no responsibility or liability for any loss of principal of the Stockholder Representative Expense Fund other than as a result of its gross negligence or willful misconduct. The Stockholder Representative is not acting as a withholding agent or in any similar capacity in connection with the Stockholder Representative Expense Fund, and has no Tax reporting or income distribution obligations. Subject to approval of the Majority Holders, the Stockholder Representative may contribute funds to the Stockholder Representative Expense Fund from any consideration otherwise distributable to the Pre-Closing Holders, and the Stockholder Representative shall distribute any funds remaining in the Stockholder Representative Expense Fund to the Pre-Closing Holders who have complied with Sections 3.2(b) , 3.2(c) and 3.2(d) , as applicable, in accordance with the Payment Spreadsheet and their respective Pro Rata Shares ( provided , that amounts payable in respect of Company Options shall be distributed to the Final Surviving Corporation for payment through its payroll system within three (3) Business Days of the date the Stockholder Representative delivers such funds to the Final Surviving Corporation and amounts payable in respect of the Company Warrant shall be distributed to the Final Surviving Corporation for payment following withholding of Taxes) at such time as the Stockholder Representative determines there are no further Stockholder Representative Expenses. For all Tax purposes, the Stockholder Representative Expense Fund shall be treated as having been received and voluntarily set aside by the Pre-Closing Holders at the time of Closing.

3.6 Exchange Agent . With respect to each payment to be paid by Buyer to the Pre-Closing Holders hereunder, promptly following the date that is one (1) year following the date that such payment is made by Buyer to the Exchange Agent, Buyer shall instruct the Exchange Agent to deliver to Buyer all cash, Certificates and other documents in its possession relating to the transactions contemplated hereby, and the Exchange Agent’s duties shall terminate. Thereafter, each Pre-Closing Holder of a Certificate (other than Certificates representing Dissenting Shares) may surrender such Certificate to Buyer and (subject to applicable abandoned property, escheat and similar Laws) receive in consideration therefor, and Buyer shall promptly pay, the portion of the Final Merger Consideration deliverable in respect thereof as determined in accordance with this Article III without any interest thereon.

3.7 Lost Certificates . In the event any Certificate has been lost, stolen or destroyed, upon the making of an affidavit of that fact and a customary indemnification of the Company and the Buyer in a form reasonably satisfactory to the Buyer by the Person claiming such Certificate to be lost, stolen or destroyed, the Exchange Agent shall issue in exchange for such lost, stolen or destroyed Certificate the Final Merger Consideration deliverable in respect thereof as determined in accordance with this Article III .

3.8 Dissenting Shares . Notwithstanding the foregoing provisions of this Article III , the Dissenting Shares shall not be converted into a right to receive any portion of the Final Merger Consideration and the holders thereof shall be entitled to such rights as are granted by Section 262 of the DGCL. Each holder of Dissenting Shares who becomes entitled to payment for such shares pursuant to Section 262 of the DGCL shall receive payment therefor from the Final Surviving Corporation in accordance with the DGCL; provided , however , that (i) if any such holder of Dissenting Shares shall have failed to establish such holder’s entitlement to appraisal rights as provided in Section 262 of the DGCL, or (ii) if any such holder of Dissenting Shares shall have effectively withdrawn such holder’s demand for appraisal of such shares or lost such holder’s right to appraisal and payment for such holder’s shares under Section 262 of the DGCL, such holder shall forfeit the right to appraisal of such shares and each such share shall not constitute a Dissenting Share and shall be treated as if it had been a Share, as applicable, immediately prior to the Effective Time and converted, as of the Effective Time, into a right to receive from the Final Surviving Corporation the portion of the Final Merger Consideration deliverable in respect thereof as determined in accordance with this Article III , without any interest thereon (and such holder shall be treated as a Pre-Closing Holder). The Company will give Buyer reasonable notice of all written notices received by the Company pursuant to Section 262 of the DGCL. Without the prior written consent of Buyer (which shall not be unreasonably withheld, conditioned or delayed), the Company shall not voluntarily make any payment with respect to, or settle or offer to settle, any such demand for payment. From and after the Effective Time, no stockholder who has properly exercised and perfected appraisal rights pursuant to Section 262 of the DGCL shall be entitled to vote his or her Shares for any purpose or receive payment of dividends or other distributions with respect to his or her Shares (except dividends and distributions payable to stockholders of record at a date which is prior to the Effective Time). Notwithstanding anything herein to the contrary, any payments required to be made to holders of Dissenting Shares pursuant to this Section 3.8 shall be made by the Final Surviving Corporation out of its own funds. No funds will be supplied for that purpose, directly or indirectly, by Buyer (or any of its Affiliates except for the Final Surviving Corporation), nor will Buyer (or any of its Affiliates except for the Final Surviving Corporation) directly or indirectly reimburse the Final Surviving Corporation for any payments to holders of Dissenting Shares.

3.9 Withholding . Buyer, the Company, the Final Surviving Corporation, the Stockholder Representative and the Exchange Agent shall be entitled to deduct and withhold from the consideration otherwise payable or deliverable in connection with the transactions contemplated by this Agreement, to any Person such amounts that Buyer, the Company, the Final Surviving Corporation, the Stockholder Representative and the Exchange Agent are required to deduct and withhold with respect to any such deliveries and payments under the Code or any provision of state, local, provincial or foreign Law. Any party otherwise proposing to withhold from a payment to a Company Stockholder to be made pursuant to this Agreement shall use commercially reasonable efforts to provide at least ten (10) days’ advance written notice to such Company Stockholder on behalf of which such withholding is to be made, and shall cooperate with any reasonable request by such party to reduce or eliminate the obligation to withhold; provided, however, that no such notice shall be required if the Company has not provided the certificate described in Section 9.2(h) or such Company Stockholder has not provided an IRS Form W-9 or applicable IRS Form W-8 requested by the withholding party. To the extent that amounts are withheld, and duly and timely deposited with the appropriate Governmental Authority, by Buyer, the Company, the Final Surviving Corporation, the Stockholder Representative or the Exchange

Agent, such withheld amounts shall be treated for all purposes of this Agreement as having been paid to the person in respect of which such deduction and withholding was made.

3.10 Milestone Payments .

(a) Additional payments (each payment set forth in any of clauses (i) through (iv) below, a “ Milestone Payment ”) shall be made by Buyer, in further consideration of the Merger being consummated, in accordance with Section 3.10(d) upon the first achievement of the applicable milestone set forth below during the Milestone Period:

(i) $25,000,000, payable in Buyer Ordinary Shares (except as otherwise set forth in Section 3.10(d) with respect to any holder of Company Options or Company Warrants or any Cash-Out Holder and subject to the Share Cap), upon the receipt of the first approval of a new drug application from the FDA for a Company Milestone Product for any indication (the “ Approval Milestone ”);

(ii) $12,500,000, payable in cash, upon first achievement of Net Sales that exceed $[**] during any calendar year (the “ Net Sales 1 Milestone ”);

(iii) $20,000,000, payable in cash, upon first achievement of Net Sales that exceed $[**] during any calendar year (the “ Net Sales 2 Milestone ”); and

(iv) $40,000,000, payable in cash, upon first achievement of Net Sales that exceed $[**] during any calendar year (the “ Net Sales 3 Milestone ”).

(v) Each Milestone Payment shall be paid no more than once and nothing herein shall imply that Buyer is obligated to seek to achieve any Milestone more than once. In no event shall Buyer pay or otherwise owe any amounts in excess of $97,500,000 in the aggregate pursuant to this Section 3.10 . For clarity, if in a given calendar year more than one of the Net Sales Milestones set forth in subsection (ii), (iii), or (iv), above, is achieved, then Buyer will pay each of the Milestone Payment Amounts set forth subsections (ii), (iii), or (iv), as applicable, with respect to each such corresponding Net Sales Milestone that is achieved for the first time during such calendar year.

(b) Certain Definitions .

(i) “ Company Milestone Product ” means any product for injection (in any dosage, form, formulation, presentation or package configuration) that contains fosfomycin as the sole active ingredient.

(ii) “ First Commercial Sale ” means the first sale of the Company Milestone Product in the Territory by a Buyer Related Entity to a Person (other than a Buyer Related Entity solely for resale) after NDA approval of the Company Milestone Product has been obtained from the FDA. For the avoidance of doubt, the sale of a Company Milestone Product for clinical trial or other developmental purposes, sampling or promotional purposes (in customary amounts), test marketing, early access programs (including treatment INDs or protocols, named patient programs

or compassionate use programs), humanitarian or charitable donations, or patient assistance programs, in each case where the Company Milestone Product is delivered for no more than a de minimis charge, shall not constitute a First Commercial Sale.

(iii) “ Milestone Payment Amount ” means the amount that becomes payable upon the achievement of a Milestone in accordance with Section 3.10(a)(i) - (iv) , as applicable.

(iv) “ Milestone Period ” means (a) with respect to the Approval Milestone, the period beginning on the Closing Date and ending upon the earlier of achievement of the Approval Milestone or the 8 th anniversary of the date on which an NDA for the Company Milestone Product is accepted; and (b) with respect to the Net Sales Milestones, if the Approval Milestone is achieved prior to the 20 th anniversary of the date on which an NDA for the Company Milestone Product is accepted, the period beginning on the date of achievement of the Approval Milestone and ending upon the later of: (i) the earliest date upon which both of the following have occurred: (A) with respect to any claim of any issued U.S. Patent Rights within the Company Intellectual Property as of the Effective Time which claim covers the composition of matter or method of manufacture or use of the Company Milestone Product in the Territory, each such claim has expired, been dedicated to the public, been founded invalid or been found unenforceable, and (B) the expiration of all applicable regulatory exclusivity periods, including pediatric extensions or data exclusivity, in the Territory with respect to the Company Milestone Product; or (ii) eight (8) years after the date of the achievement of the Approval Milestone.

(v) “ Net Sales ” means, for the applicable period during the Milestone Period, the aggregate gross amount (expressed in U.S. dollars and calculated in accordance with GAAP, applied consistent with past practices of Buyer (if it, the Final Surviving Corporation or any of its or their Affiliates is the selling Person) or its or their licensee (if it is the selling Person)) invoiced by Buyer and/or the Final Surviving Corporation and its or their Affiliates and licensees (collectively, the “ Buyer Related Entities ”) for sales in the Territory of Company Milestone Products to a Person who is not a Buyer Related Entity, as determined in accordance with GAAP, as consistently applied by Buyer (if it, the Final Surviving Corporation or any of its or their Affiliates is the selling Person) or its or their licensee (if it is the selling Person), minus the sum of the following, to the extent actually borne or incurred by a Buyer Related Entity and not reimbursed:

A. reasonable and customary freight, postage, shipping and insurance, handling and other transportation costs to the extent such amounts are included in the gross invoiced price;

B. sales, use, value added and other similar Taxes (excluding income, withholding and similar Taxes) to the extent such amounts are included in the gross invoiced price;

C. tariffs, customs duties, surcharges and other compulsory governmental charges to the extent such amounts are included in the gross invoiced price;

D. excise tax payments pursuant to Section 9008 of the Patient Protection and Affordable Care Act of 2010, and any similar payments under applicable Law;

E. normal and customary trade discounts, credits or allowances (including cash or volume) actually given;

F. rebates, fees, credits, allowances, administrative fees and charge backs, including those granted to any managed care organization, wholesaler, distributor, buying group, health care insurance carrier, chain pharmaceutical, mass merchandiser, staff model HMO, pharmacy benefit manager, hospital buying group or group purchasing organization;

G. credits or allowances for returns, rejections or recalls; and

H. retroactive price reductions to be applied in the year provided.

There shall be no double counting in determining the foregoing deductions from gross amounts invoiced to calculate Net Sales. Sales or other commercial dispositions of a Company Milestone Product between or among Buyer Related Entities for resale shall be excluded from the computation of Net Sales; provided, however, that any subsequent sale of a Company Milestone Product by any Buyer Related Entity to another Person that is not a Buyer Related Entity shall be included within Net Sales. Notwithstanding the foregoing, a Company Milestone Product provided for no more than a de minimis charge by a Buyer Related Entity for clinical trial or other developmental purposes, sampling or promotional purposes (in customary amounts), test marketing, early access programs (including treatment INDs or protocols, named patient programs or compassionate use programs), humanitarian or charitable donations, or patient assistance programs will not be included in Net Sales.

(vi) “ Territory ” means the United States of America and its territories and possessions, including the Commonwealth of Puerto Rico and the District of Columbia.

(i) Approval Milestone . Within ten (10) Business Days of the occurrence of the Approval Milestone during the Milestone Period, Buyer shall provide notice to the Stockholder Representative that the Approval Milestone has occurred. From and after the Effective Time and until the earlier of the achievement of the Approval Milestone or the expiration of the Milestone Period, (A) Buyer shall provide the Stockholder Representative, on an biannual basis, a written report covering Buyer’s activities for the preceding period with respect to the Company Milestone Products, and (B) upon reasonable request to Buyer by the Stockholder Representative, made no more than twice per calendar year, Buyer shall meet with the Stockholder Representative, at Buyer’s offices or via telephone or video conference, to provide verbal updates regarding the development status of the Company Milestone Products.

(ii) Net Sales Milestone . No later than sixty (60) days after the end of each completed fiscal quarter after the First Commercial Sale of a Company Milestone Product and prior to the earlier of the achievement of the Net Sales Milestones and the expiration of the Milestone Period, Buyer shall provide the Stockholder Representative with financial information and supporting information calculating Net Sales for such fiscal quarter (the “ Net Sales Report ”). If Buyer determines that any Net Sales Milestone has been achieved, Buyer shall, along with the applicable Net Sales Report, provide notice to the Stockholder Representative that such Net Sales Milestone has been achieved. For clarity, more than one of the Net Sales Milestones may be achieved in a calendar year. If the Stockholder Representative does not agree with Buyer’s calculation of Net Sales at any time, Buyer shall consider the Stockholder Representative’s comments in good faith, and Buyer and the Stockholder Representative shall negotiate in good faith to resolve such dispute. Following First Commercial Sale, until the earlier of the achievement of the Net Sales Milestones and the expiration of the Milestone Period, and for one year thereafter, Buyer shall keep (and shall cause its Affiliates, including the Final Surviving Corporation, to keep) books and records pertaining to Net Sales for the prior three (3) calendar years, in sufficient detail to determine such Net Sales. During the period in which such books and records must be maintained, the Stockholder Representative shall have the right to cause the Independent Auditor to audit such books and records to confirm Buyer’s calculations of such Net Sales, and such audits may be exercised during normal business hours upon reasonable prior notice (of at least thirty (30) days) to Buyer, such right to be exercised no more than once per calendar year; provided, that the Independent Auditor executes a reasonable confidentiality agreement with Buyer to protect the confidentiality in such books and records. Such books and records for any period may be audited no more than once. The Stockholder Representative shall bear the full cost of such audit unless such audit discloses that the Net Sales reported by Buyer for any such audited calendar year were more than five percent (5%) lower than the actual Net Sales in such calendar year, in which case, Buyer shall reimburse the Stockholder Representative for the reasonable out-of-pocket cost of the Independent Auditor for the conduct of such audit. The Independent Auditor’s calculation of Net Sales pursuant to such an audit shall be final and binding on the parties hereto.

(d) Milestone Payment Procedures . Within five (5) Business Days following the Stockholder Representative’s receipt of notice from Buyer (or, in the case of a Net Sales Milestone, if applicable, subject to a final determination by the Independent Auditor pursuant to an audit described in Section 3.10(c)(ii) ) that either the Approval Milestone or a Net Sales Milestone has been achieved, or, if applicable, that a Milestone Acceleration or Continuation Event has occurred and Buyer has elected to pay an Acceleration Payment with respect to a particular Milestone, Buyer shall deliver to the Exchange Agent, by wire transfer of immediately available funds or in Buyer Ordinary Shares (as the case may be), the applicable Milestone Payment Amount payable in connection with the occurrence of such event pursuant to the terms of this Agreement, for distribution to the Pre-Closing Holders who have complied with Sections 3.2(b), 3.2(c) and 3.2(d) , as applicable ( provided , that, notwithstanding anything herein to the contrary, in lieu of any Buyer Ordinary Shares otherwise issuable in respect of Company

Options or the Company Warrant, or to any Cash-Out Holder, as a Milestone Payment a cash amount equal to the number of such Buyer Ordinary Shares multiplied by the Milestone Share Price shall be paid, and provided further that amounts payable in respect of Company Options shall be paid by the Exchange Agent to the Final Surviving Corporation for payment through its payroll system within three (3) Business Days of the date the Exchange Agent delivers such funds to the Final Surviving Corporation), and, if applicable, any recipients of Transaction Expenses, in accordance with an updated Payment Spreadsheet to be provided by the Stockholder Representative to the Exchange Agent; provided, in the case of the Milestone Payment for the Approval Milestone, that if the deadline under this Section 3.10(d) for delivery of such Milestone Payment would otherwise occur prior to the end of the Milestone Share Price Measurement Period, the deadline for Buyer to deliver such Milestone Payment under this Section 3.10(d) shall instead be the second (2 nd ) Business Day following the expiration of such Milestone Share Price Measurement Period.

(e) Milestone Achievement Efforts . Following the Effective Time, Buyer and its Affiliates shall act in good faith and shall use Milestone Reasonable Efforts to cause each of the Milestones to be achieved during the applicable Milestone Period. “ Milestone Reasonable Efforts ” means the performance of commercially reasonable efforts that are at least commensurate with the level of efforts that Buyer devotes in pursuing the NDA approval or commercialization in the Territory, as applicable to the relevant Milestone, of its own product candidates of similar market potential, profit potential or strategic value at a similar stage in its lifecycle, taking into consideration the safety and efficacy of the product, the risks inherent in the development and commercialization of the product, its competitiveness compared to alternative products (other than those developed by the Buyer Related Entities), the proprietary position of the product (including scope and duration of relevant Patent Rights), the scope of marketing approval, the regulatory status of the product, and whether the product is subject to a clinical hold, recall or market withdrawal. Buyer further agrees not to take any action for the primary purpose of undermining the achievement of the unachieved Milestones. Without limiting Buyer’s obligations under this Section 3.10(e) , Buyer does not represent or warrant that the development, NDA approval or commercialization of the Company Milestone Product in the Territory will be successful.

(f) Milestone Acceleration or Continuation Event . Notwithstanding any other provision contained in this Agreement to the contrary, in the event a Milestone Acceleration or Continuation Event occurs during an applicable Milestone Period (i) at any time before the Approval Milestone has been achieved or (ii) at any time before all of the Net Sales Milestones have been achieved, Buyer may, in its sole discretion upon the determination of its Board of Directors, elect to pay with respect to any Milestone not yet achieved, on a Milestone-by-Milestone basis and in accordance with Section 3.10(d) above, an amount equal to the unpaid Milestone Payment with respect to such Milestone (an “ Acceleration Payment ”), the payment of which shall satisfy all payment obligations of Buyer with respect to such Milestone Payment, provided that such election shall only be effective if notice thereof is provided to the Stockholder Representative within twenty (20) Business Days after the applicable Milestone Acceleration or Continuation Event. In the event that no such notification has been provided within such twenty (20)-Business

Day period, or such notification has been provided but there remain unpaid Milestone Payments, the terms and provisions of this Section 3.10 shall continue in accordance with their terms and Buyer shall require the relevant successor of Buyer (the “ Successor Entity ”), if applicable (whether direct or indirect, by purchase, merger, sale of stock or assets, consolidation or otherwise), pursuant to the Milestone Acceleration or Continuation Event, to assume and agree, in writing, to perform Section 3.10 of this Agreement, in the same manner and to the same extent that Buyer would have been required to perform if no such succession had taken place; provided that for purposes of the definition of Milestone Reasonable Efforts with respect to such Successor Entity, the reference to “Buyer” in such definition shall still be deemed to refer to Buyer, and not to the Successor Entity, as Buyer existed prior to any transactions related to the acquisition of any rights or obligations by the Successor Entity. For purposes of this Section 3.10 , a “ Milestone Acceleration or Continuation Event ” shall mean any of the following events: (w) a sale, license, conveyance, assignment or other disposition of all or substantially all of the assets of Buyer and its Subsidiaries on a consolidated basis (other than to Buyer or any Subsidiary (direct or indirect) of Buyer), (x) a merger or consolidation in which Buyer is not the surviving entity and in which the stockholders of Buyer immediately prior to such consolidation or merger own less than fifty percent (50%) of the surviving entity’s voting power immediately after the transaction, (y) a reverse merger in which Buyer is the surviving entity but the shares of Buyer’s common stock outstanding immediately preceding the merger are converted by virtue of the merger into other property, whether in the form of securities, cash or otherwise, and in which the stockholders of Buyer immediately prior to such reverse merger own less than fifty percent (50%) of Buyer’s voting power immediately after the transaction and (z) a sale, exclusive license, conveyance, assignment or other disposition of all of Buyer’s and its Affiliates’ interest, directly or indirectly, in the Company Milestone Products in the Territory.

(g) With respect to Milestone Payments payable in Buyer Ordinary Shares, the number of Buyer Ordinary Shares to be issued in respect thereof shall be determined by dividing the amount of such payment obligation by the volume weighted average price of a Buyer Ordinary Share over the twenty (20) trading-day period ending three (3) trading days prior to the date of issuance of such shares, as reported by Bloomberg with any fractional amounts rounded down, provided that in the case of the Milestone Payment for the Approval Milestone the applicable period for measuring the volume weighted average price of a Buyer Ordinary Share shall instead be the twenty (20) trading-day period commencing on the tenth (10 th ) trading day prior to public announcement by Buyer of the achievement of the Approval Milestone (such price, the “ Milestone Share Price ” and such applicable measurement period, the “ Milestone Share Price Measurement Period ”). Notwithstanding anything to the contrary set forth in this Agreement (but subject to the Share Cap), Buyer shall have right to settle any payment obligation under this Section 3.10 (other than amounts payable in respect of Company Options and the Company Warrant and to any Cash-Out Holder, which shall in all events be paid in cash) by issuing a number of Buyer Ordinary Shares calculated in the manner specified in the preceding sentence; provided, however, that the Buyer shall not settle any payment obligation under this Section 3.10 in Buyer Ordinary Shares if the settlement in shares would cause the Company to be an expatriated entity within the

meaning of Section 7874 of the Code.

(h) The parties understand and agree that (i) the rights of the Pre-Closing Holders under this Section 3.10 shall not be evidenced by a certificate, (ii) the Pre-Closing Holders shall have no rights as a security holder of the Final Surviving Corporation or Buyer (or any of their respective Affiliates) as a result of their respective rights under this Section 3.10 and (iii) no right to receive any Milestone Payment may be assigned or otherwise transferred by any Pre-Closing Holder (other than (x) by will or the laws of descent and distribution or (y) to an Affiliate of such Pre-Closing Holder, in each case in accordance with applicable Law) without the prior written consent of Buyer (which consent shall not be unreasonably withheld, conditioned or delayed) and any purported assignment or transfer in the absence of such consent shall be null and void ab initio .

3.11 Legend . All certificates representing any Buyer Ordinary Shares that may be issued pursuant to this Agreement shall have restrictive legends in the following form:

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR QUALIFIED UNDER ANY APPLICABLE STATE SECURITIES LAWS (THE “STATE ACTS”), HAVE BEEN ACQUIRED FOR INVESTMENT AND MAY NOT BE SOLD, PLEDGED, HYPOTHECATED OR OTHERWISE TRANSFERRED EXCEPT PURSUANT TO A REGISTRATION STATEMENT UNDER THE SECURITIES ACT AND QUALIFICATION UNDER THE STATE ACTS OR EXEMPTIONS FROM SUCH REGISTRATION OR QUALIFICATION REQUIREMENTS (INCLUDING, IN THE CASE OF THE SECURITIES ACT, E.G. THE EXEMPTION AFFORDED BY RULE 144 THEREUNDER).

THE SECURITIES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO AN AGREEMENT RESTRICTING THE VOTING AND TRANSFER THEREOF (A COPY OF WHICH MAY BE OBTAINED UPON WRITTEN REQUEST FROM THE COMPANY), AND BY ACCEPTING ANY INTEREST IN SUCH SHARES THE PERSON ACCEPTING SUCH INTEREST SHALL BE DEEMED TO AGREE TO AND SHALL BECOME BOUND BY THE PROVISIONS OF THAT AGREEMENT.

3.12 No Fractional Shares . No fractional Buyer Ordinary Shares will be issued to the Pre-Closing Holders under this Agreement, and any fraction of a Buyer Ordinary Share shall be rounded down to the nearest whole number.

3.13 Issuance of Shares after Closing . Any issuance of Holdback Shares and any Milestone Payment paid in Buyer Ordinary Shares shall be treated as comprised of two components, a principal component and an interest component, the amounts of which shall be determined as provided in Treasury Regulations Section 1.483-4(b) example (2), using the 3-month test rate of interest provided for in Treasury Regulations Section 1.1274-4(a)(1)(ii) employing the semiannual compounding period. As to each such payment of Buyer Ordinary Shares to each Pre-Closing Holder, Buyer Ordinary Shares representing the principal component (with a value equal to the principal component) and Buyer Ordinary Shares representing the interest component (with a

value equal to the interest component) shall be represented by separate share certificates or book entry accounts.

ARTICLE IV.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY

Except as set forth in the schedules to this Agreement (each, a “ Schedule ” and, collectively, the “ Disclosure Schedules ”), the Company represents and warrants to Buyer and Merger Subs as follows:

4.1 Corporate Organization of the Company . The Company has been duly incorporated and is validly existing as a corporation in good standing under the Laws of the State of Delaware and has the corporate power and authority to own or lease its properties and to conduct its business as it is now being conducted. The copies of the Company Charter and the Company Bylaws previously made available by the Company to Buyer or its representatives are true and complete. The Company is duly licensed or qualified to do business and (where applicable) is in good standing as a foreign corporation in each jurisdiction in which the ownership of its property or the character of its activities is such as to require it to be so licensed or qualified or in good standing, as applicable, except where the failure to be so licensed or qualified or in good standing would not reasonably be expected to have a Material Adverse Effect on the Company.

4.2 Subsidiaries . The Company does not have, and has never had, any Subsidiaries.

4.3 Due Authorization . The Company has all requisite corporate power and authority to execute and deliver this Agreement and (subject to the consents, approvals, authorizations and other requirements described in Section 4.5 ) to consummate the transactions contemplated hereby. The execution and delivery of this Agreement by the Company and the consummation by the Company of the transactions contemplated hereby have been duly and validly authorized and approved by the Board of Directors of the Company, and no other corporate proceeding on the part of the Company is necessary to authorize this Agreement (other than the Merger Consent). Without limiting the generality of the foregoing, the Board of Directors of the Company, at a meeting duly called and held, by the unanimous vote of all directors (i) determined that the First Merger is advisable, fair and in the best interests of the Company and its stockholders, (ii) approved this Agreement in accordance with the provisions of the DGCL, and (iii) directed that this Agreement and the First Merger be submitted to the stockholders of the Company for their adoption and approval and resolved to recommend that the stockholders of the Company vote in favor of the adoption of this Agreement and the approval of the First Merger. This Agreement has been duly and validly executed and delivered by the Company and (assuming this Agreement constitutes a legal, valid and binding obligation of Buyer and Merger Subs) constitutes a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, subject to applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and similar Laws affecting creditors’ rights generally and subject, as to enforceability, to general principles of equity (collectively, the “ Remedies Exception ”).

4.4 No Conflict . Except as set forth on Schedule 4.4 and subject to the receipt of the consents, approvals, authorizations and other requirements set forth in Section 4.5 or on Schedule 4.5 , the execution and delivery of this Agreement by the Company and the consummation by the Company of the transactions contemplated hereby do not and will not, as of the Closing, (a) violate any

provision of, or result in the breach of, any applicable Law to which the Company is subject or by which any property or asset of the Company is bound, (b) conflict with or violate any provision of the Company Charter, Company Bylaws or other organizational documents of the Company, (c) violate any provision of or result in a breach of, or require a consent or constitute (with or without due notice or lapse of time or both) a default under, any Contract listed on Schedule 4.12 , or terminate or result in the termination of any such Contract, or result in the creation of any Lien under any such Contract upon any of the properties or assets of the Company, or constitute an event which, after notice or lapse of time or both, would result in any such violation, breach, termination or creation of a Lien or create in any party the right to accelerate or modify such Contract, or (d) result in a violation or revocation of any required license, permit or approval from any Governmental Authority, except to the extent that the occurrence of any of the foregoing items set forth in clauses (a), (c) or (d) would not reasonably be expected to have a Material Adverse Effect on the Company.

4.5 Governmental Consents . Assuming the truth and completeness of the representations and warranties of Buyer contained in this Agreement, no consent, approval or authorization of, or designation, declaration or filing with, any Governmental Authority is required on the part of the Company with respect to the Company’s execution or delivery of this Agreement or the consummation by the Company of the transactions contemplated hereby, except (a) for any material consents, approvals, authorizations, designations, declarations or filings, (b) compliance with any applicable securities Laws, (c) as otherwise disclosed on Schedule 4.5 and (d) for the filing of the Certificate of Merger in accordance with the DGCL.

4.6 Capitalization of the Company .

(a) The authorized capital stock of the Company consists of:

(i) 51,000,000 shares of Company Common Stock, 7,805,210 of which are issued and outstanding as of the date of this Agreement (of which 6,050,000 are subject to Company Restricted Stock Awards).

(ii) 36,100,000 shares of Company Series A Preferred Stock, 35,862,714 of which are issued and outstanding as of the date of this Agreement.

All of the issued and outstanding shares of Company Capital Stock have been duly authorized and validly issued and are fully paid and nonassessable and have not been issued in violation of any preemptive or similar rights. All of the issued and outstanding shares of capital stock of the Company have been offered, issued and sold by the Company in material compliance with all applicable federal and state securities Laws.

(b) As of the date hereof, 3,974,010 shares of Company Common Stock are subject to outstanding Company Options and 185,185 shares of Company Series A Preferred Stock are subject to the Company Warrant. Schedule 4.6(b) sets forth with respect to each Company Option and the Company Warrant, as of the date hereof, the name of the holder thereof, the number of vested and unvested shares of Company Common Stock subject thereto and the purchase price or exercise price, the date of grant, and the vesting schedule (including any acceleration provisions with respect thereto), as applicable, thereof. The Company has delivered or made available to Buyer an accurate and complete

copy of the Company Equity Plan.

(c) Schedule 4.6(c) sets forth a complete and accurate list, as of the date of this Agreement, of: (i) any equity incentive or stock incentive plan of the Company other than the Company Equity Plan, (ii) the number of shares of Company Capital Stock issued to date under the Company Equity Plan, the number of shares of Company Capital Stock subject to outstanding options under the Company Equity Plan and the number of shares of Company Capital Stock reserved for future issuance under the Company Equity Plan, and (iii) subject to Schedule 4.6(b) above, all other outstanding Company equity awards, indicating with respect to each such award the name of the holder thereof, the number and class or series of shares of Company Capital Stock subject to such award, the date of grant, and the vesting schedule. The Company has made available to the Buyer complete and accurate copies of the Company Equity Plan (and all amendments thereto), forms of all stock option agreements evidencing Company Options and all agreements evidencing Company Warrants. All of the shares of capital stock of the Company subject to Company Options and Company Warrants will be, upon issuance pursuant to the exercise of such instruments, duly authorized, validly issued, fully paid, nonassessable and free of all preemptive rights.

(d) With respect to each Company Option (whether outstanding or previously exercised), (i) each such Company Option intended to qualify as an “incentive stock option” under Section 422 of the Code so qualifies, (ii) each grant of a Company Option was duly authorized no later than the date on which the grant of such Company Option was by its terms to be effective (the “ Grant Date ”) by all necessary corporate action, including, as applicable, approval by the Company’s Board of Directors (or a duly constituted and authorized committee thereof), or a duly authorized delegate thereof, and any required stockholder approval by the necessary number of votes or written consents, and the award agreement governing such grant (if any) was duly executed and delivered by each party thereto no later than the Grant Date and (iii) each such grant was made in accordance with, in all material respects, the terms of the Company Equity Plan, the Exchange Act, to the extent applicable, and all other applicable Laws.

(e) Except as set forth in Section 4.6(a) , Schedule 4.6(b) , Schedule 4.6(c) or Section 4.6(f) , (i) there are no equity interests of any class of the Company, or any security exchangeable into or exercisable for such equity interests, issued, reserved for issuance or outstanding, (ii) there are no options, warrants, equity securities, calls, rights, commitments or agreements to which the Company is a party or by which the Company is bound obligating the Company to issue, exchange, transfer, deliver or sell, or cause to be issued, exchanged, transferred, delivered or sold, additional shares of capital stock or other equity interests of the Company or any security or rights convertible into or exchangeable or exercisable for any such shares or other equity interests, or obligating the Company to grant, extend, otherwise modify or amend or enter into any such option, warrant, equity interest, call, right, commitment or agreement, (iii) the Company has no obligation (contingent or otherwise) to issue any subscription, warrant, option, convertible security or other such right, or to issue or distribute to holders of any equity interests of the Company any evidences of Indebtedness or assets of the Company, and (iv) the Company has no obligation (contingent or otherwise) to purchase, redeem or

otherwise acquire any equity interests or to pay any dividend or to make any other distribution in respect thereof.

(f) Except as set forth in Schedule 4.6(f) , there is no agreement, written or oral, between the Company and any holder of its securities, or, to the Company’s knowledge, among any holders of its securities, relating to the sale or transfer (including agreements relating to rights of first refusal, co-sale rights or “drag along” rights), registration under the Securities Act or the securities Laws of any other jurisdiction, or voting, of the capital stock of the Company.

4.7 Financial Statements . Attached as Schedule 4.7 are (a) the audited balance sheets and statements of operations, convertible preferred stock and stockholders’ deficit and cash flow of the Company as of and for the twelve-month periods ended December 31, 2017 and December 31, 2016 (the “ Year-End Financial Statements ”) and (b) an unaudited balance sheet and statements of operations and cash flow of the Company as of and for the six-month period ended June 30, 2018 (the “ Interim Financial Statements ” and, together with the Year-End Financial Statements, the “ Financial Statements ”). The Financial Statements present fairly, in all material respects, the financial position, results of operations and cash flows of the Company as of the dates and for the periods indicated in such Financial Statements in conformity with GAAP (except in the case of the Interim Financial Statements for the absence of footnotes and other presentation items and for normal year-end adjustments) and each is consistent with the books and records of the Company. The Company maintains materially accurate books and records reflecting its assets and liabilities and maintains proper and adequate internal accounting controls.

4.8 Undisclosed Liabilities . Except as set forth on Schedule 4.8 , there is no liability, debt or obligation of the Company, except for liabilities and obligations (a) reflected or reserved for on the Financial Statements or disclosed in the notes thereto, (b) that have arisen since the date of the most recent balance sheet included in the Financial Statements in the ordinary course of the operation of business of the Company, (c) disclosed in the Disclosure Schedules or (d) contractual and other liabilities incurred in the ordinary course of business that are not required by GAAP to be reflected on a balance sheet and that are not in the aggregate material (in each case, none of which results from, arises out of, relates to, is in the nature of, or was caused by any breach of contract, breach of warranty, tort, infringement or violation of Law).

4.9 Litigation and Proceedings . Except as set forth on Schedule 4.9 , as of the date of this Agreement, there are no pending or, to the knowledge of the Company, threatened, lawsuits, actions, suits, claims or other proceedings at law or in equity or, to the knowledge of the Company, investigations, in each case, before or by any Governmental Authority against or involving the Company or any current or former officer, director, employee, consultant, agent or stockholder of the Company or any Subsidiary in its, his or her capacity as such or with respect to the Company that, in each case, if resolved adversely to the Company, could reasonably be expected to result in material liability to the Company. There are no judgments, orders, injunctions, decrees, stipulations or awards (whether rendered by a court, administrative agency or other Governmental Authority, by arbitration or otherwise) against or involving the Company. There is no legal proceeding by the Company pending, or which the Company has commenced preparations to initiate, against any other Person.

4.10 Compliance with Laws . The Company is in compliance, and has, in the past three (3) years, conducted its business in compliance, in all material respects with all applicable Laws. The Company has not received any written notice from any Governmental Authority (including the FDA) of a material violation of any applicable Law at any time during the past three (3) years.

4.11 FDA Matters .

(a) As to each of the product candidates of the Company, including compounds currently under research and/or development by the Company and subject to the jurisdiction of the FDA or any equivalent Governmental Authority in any legal jurisdiction other than the U.S. (including, for clarity, fosfomycin) (each such product, a “ Company Regulated Product ”), such Company Regulated Product is being researched, developed, manufactured, stored and tested in compliance in all material respects with all applicable Laws. During the past two (2) years, the Company has not received any written notice or other written communication from any Governmental Authority alleging any material violation by the Company of any Law applicable to a Company Regulated Product.

(b) To the knowledge of the Company, the Company has not made any untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Authority or otherwise failed to disclose a material fact required to be disclosed to the FDA or any Governmental Authority.

(c) All preclinical studies and clinical trials, and other studies and tests of any Company Regulated Product conducted by or on behalf of the Company have been, and if still pending are being, conducted in material compliance, to the extent applicable with all applicable Laws, including the FDCA and its implementing regulations governing good laboratory practices and good clinical practices, and the respective counterparts thereof outside the United States. All clinical trials conducted by or for the benefit of the Company have been in the past three (3) years, and are being, conducted in material compliance with all applicable Laws, including, without limitation, 21 C.F.R. Parts 50, 54, 56, and 312 of the U.S. Code of Federal Regulations. No clinical trial conducted by or on behalf of the Company has been terminated or placed on clinical hold by the FDA for safety reasons prior to scheduled completion, and neither the FDA nor any other applicable Governmental Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company has initiated, or, to the Company’s knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation of the Company Regulated Products conducted or proposed to be conducted by or on behalf of the Company, and any other standards comprising good clinical practices.

(d) All documents filed by the Company with the FDA or any other Governmental Authority with respect to the Company Regulated Products, or the manufacturing, handling, storage or shipment of the Company Regulated Products were, at the time of filing, true, complete and accurate in all material respects.

(e) The Company has not received any written notice that the FDA or any other Governmental Authority has commenced, or, to the Company’s knowledge, threatened in

writing to initiate, any action to enjoin production of the Company Regulated Products at any of its or its suppliers’ facilities.

(f) Neither the Company nor, to the knowledge of the Company, any officer, employee or agent of the Company has been convicted of any crime or engaged in any conduct that has caused or would reasonably be expected to result in (A) disqualification or debarment by the FDA under 21 U.S.C. Section 335a, or any similar law, rule or regulation of any other Governmental Authority, or (B) exclusion from federal health care programs under 42 U.S.C. Sections 1320a-7 or 1320a-7a, or any similar law, rule or regulation of any Governmental Authority.

(g) Within the past three (3) years, the Company has not received from any Governmental Authority (i) any warning letters, untitled letters, or similar written correspondence alleging material noncompliance by the Company with applicable Laws, or (ii) any unresolved inspection reports and Form FDA 483s identifying material noncompliance with the FDCA. To the knowledge of the Company, neither FDA nor any other Governmental Authority intends to bring any such action against the Company.

4.12 Contracts; No Defaults .

(a) Schedule 4.12 contains a listing of all of the following Contracts to which the Company is a party (other than Company Benefit Plans and Contracts for labor and employment matters set forth on Schedule 4.14 ):

(i) Each Contract that the Company reasonably anticipates will involve annual payments or consideration furnished by or to the Company of more than $100,000;

(ii) Each note, debenture, other evidence of indebtedness, guarantee, loan, credit or financing agreement or instrument or other Contract for money borrowed by the Company, in each case, having an outstanding principal amount in excess of $100,000;

(iii) Each Contract for the acquisition of any Person or any business division thereof or the disposition of any material assets of the Company (other than in the ordinary course of business);

(iv) Each lease, rental or occupancy agreement, real property license, installment and conditional sale agreement or other Contract that, in each case, provides for the ownership of, leasing of, title to, use of, or any leasehold or other interest in any real or personal property;

(v) Each Contract providing for any royalty, milestone or similar payments by the Company due on or after the date hereof;

(vi) Each joint venture Contract, partnership agreement or limited liability company agreement with a third party;

(vii) Each Contract requiring capital expenditures after the date of this Agreement in an annual amount in excess of $100,000;

(viii) Each Contract in which the Company is subject to noncompetition or non-solicitation (other than confidentiality agreements with customers of the Company set forth in the Company’s standard terms and conditions of sale or standard form of employment agreement, forms of which have previously been made available to the Buyer) that restricts the Company in any material respect;

(ix) Each employment agreement, consulting agreement, severance agreement (or agreement that includes provisions for the payment of severance), change in control, or retention agreement providing annual compensation in excess of $100,000;

(x) Each settlement agreement settling claims against the Company or one of its current or former directors, officers, employees or consultants (including any agreement in connection with which any employment-related claim is settled);

(xi) Each Contract which contains any provisions with ongoing obligations requiring the Company to indemnify any other party (excluding indemnities contained in agreements for the purchase, sale or license of products or services entered into in the ordinary course of business);

(xii) Each Contract containing covenants materially limiting (1) the types of business in which the Company (or, after giving effect to the First Merger, Buyer or its Affiliates) may engage (2) the geographic locations in which the Company (or, after giving effect to the First Merger, Buyer or its Affiliates) may so engage in any business or (3) the products that the Company (or, after giving effect to the First Merger, Buyer or its Affiliates) may research, develop, manufacture or commercialize; and

(xiii) Each Contract containing covenants materially limiting the freedom of the Company to engage in any business; and

(xiv) Each Contract pursuant to which the Company (A) licenses from, or has otherwise been assigned, transferred or granted any covenant not to assert by, a third party, any Intellectual Property used in connection with the Exploitation of any Company Regulated Product that is material to the Company’s business (other than (1) (x) click-wrap, shrink-wrap and off-the-shelf software licenses, and (y) any other software licenses that are available on standard terms to the public generally, in each case of (x) and (y) with license, maintenance, support and other fees less than $10,000 per year) and (2) standard employee and consultant assignment agreements in the form provided to Buyer), (B) has licensed, assigned, sold or transferred to a third party, or otherwise granted to a third party, any right or covenant not to assert under any Company Intellectual Property, or (C) has agreed to indemnify a third party against any claim of infringement, violation or misappropriation of any Intellectual Property.

(b) True and complete copies of the Contracts listed (or required to be listed) on Schedule 4.12 have been delivered to or made available to Buyer or its representatives. Except as set forth on Schedule 4.12 , all of the Contracts set forth (or required to be set forth) on Schedule 4.12 are (i) in full force and effect, subject to the Remedies Exception, and (ii) represent the valid and binding obligations of the Company party thereto and, to the knowledge of the Company, represent the valid and binding obligations of the other parties thereto. Except as set forth on Schedule 4.12 , (x) neither the Company nor, to the knowledge of the Company, any other party thereto is in material breach of or material default under any such Contract, (y) as of the date of this Agreement, the Company has not received any claim or notice of material breach of or material default under any such Contract, and (z) to the knowledge of the Company, no event has occurred which, individually or together with other events, would reasonably be expected to result in a material breach of or a material default under any such Contract (in each case, with or without notice or lapse of time or both).

4.13 Company Benefit Plans .

(a) Schedule 4.13 lists each material “employee benefit plan” (as defined in Section 3(3) of ERISA) and each other material compensation plan, program, agreement or arrangement that is maintained, sponsored or contributed to by the Company for the benefit of its current or former employees or with respect to which the Company has any liability (collectively, the “ Company Benefit Plans ”). The Company has made available to Buyer true and complete copies of (i) each Company Benefit Plan and any summary plan descriptions thereof, (ii) Forms 5500 in each of the most recent three (3) plan years, including all schedules thereto, (iii) with respect to any Company Benefit Plan that purports to meet the requirements of Section 401(a) of the Code, the most recent determination letter issued by the IRS, (iv) all material notices that were given by any Governmental Authority to the Company any Company Benefit Plan during the past five (5) years, and (v) any trust documents, funding vehicles and any material third-party Contracts with respect to such Company Benefit Plan. The Company does not utilize a “professional employer organization” (PEO), employee leasing company or other similar organization to provide benefits to its workforce. No Company Benefit Plan is subject to non-U.S. law.

(b) Each Company Benefit Plan has been operated in material compliance with its terms and the requirements of such Company Benefit Plan and all applicable Laws. No proceeding is pending or, to the knowledge of the Company, threatened with respect to any Company Benefit Plan (other than claims for benefits in the ordinary course of business) that could reasonably be expected to result in material liability to the Company.

(c) Each Company Benefit Plan that is intended to be qualified under Section 401(a) of the Code has received a favorable determination or opinion letter from the IRS, or has pending or has time remaining in which to file an application for such a determination from the IRS. There has been no prohibited transaction (within the meaning of Section 406 of ERISA or Section 4975 of the Code, other than a transaction that is exempt under a statutory or administrative exemption) with respect to any Company Benefit Plan that could result in a Material Adverse Effect. No suit, administrative

proceeding, action or other litigation has been brought, or to the knowledge of the Company, is threatened against or with respect to any such Company Benefit Plan, including any audit or inquiry by the IRS or United States Department of Labor (other than routine benefits claims) that could reasonably be expected to result in a Material Adverse Effect.

(d) No Company Benefit Plan is, none of the Company nor any ERISA Affiliate has ever maintained, contributed to or otherwise had an obligation in respect of, a “multiemployer plan” within the meaning of Section 3(37) of ERISA or a “pension plan” under Section 3(2) of ERISA that is subject to Title IV of ERISA. No Company Benefit Plan that is funded include securities issued by the Company or any ERISA Affiliate. No Company Benefit Plan is funded by or associated with a “voluntary employee’s beneficiary association” within the meaning of Section 501(c)(9) of the Code.

(e) Neither the execution and delivery of this Agreement, nor the consummation of the transactions contemplated hereby, either alone or in combination with another event (whether contingent or otherwise) would, as of the Closing, reasonably be expected to give rise to any “excess parachute payment” under Section 280G of the Code. Section 4.13(e) of the Disclosure Schedule discloses each: (i) agreement with any stockholder, director, executive officer or other key employee of the Company (A) the benefits of which are contingent, or the terms of which are altered, upon the occurrence of a transaction involving the Company of the nature of any of the transactions contemplated by this Agreement, (B) providing any term of employment or compensation guarantee or (C) providing severance benefits or other benefits after the termination of employment of such stockholder, director, executive officer or key employee; and (ii) agreement or plan binding the Company, including any stock option plan, stock appreciation right plan, restricted stock plan, stock purchase plan, severance benefit plan or Company Benefit Plan, any of the benefits of which will be increased, or the vesting of the benefits of which will be accelerated, by the occurrence of any of the transactions contemplated by this Agreement or the value of any of the benefits of which will be calculated on the basis of any of the transactions contemplated by this Agreement.

(f) Except as required by Law, no Company Benefit Plan provides any post-employment medical or life insurance benefits, except for those contractual obligations to pay or reimburse any premiums an employee or former employee may pay in order to obtain health coverage under Section 4980B(b) of the Code or other applicable similar law regarding health care coverage continuation (collectively, “ COBRA ”) set forth on Schedule 4.13(f) .

(g) Each Company Benefit Plan that is a “nonqualified deferred compensation plan” (as defined in Code Section 409A(d)(1)) has been operated in good faith compliance with Code Section 409A. No service provider to the Company has incurred liability for tax imposed under Section 409A(a)(1)(B) in connection with participation in any Company Benefit Plan or otherwise as a result of the service provider’s arrangements with the Company. No stock option or equity unit granted by the Company has an exercise price that has been or may be less than the fair market value of the underlying stock or equity units (as the case may be) as of the date such option or unit was granted or has any feature

for the deferral of compensation other than the deferral of recognition of income until the later of exercise or disposition of such option.

4.14 Employment and Labor Relations .

(a) The Company is in compliance in all material respects with all applicable Laws and its own policies respecting labor and employment matters, including, but not limited to, fair employment practices, terms and conditions of employment, workers’ compensation, family and medical leave, occupational safety, plant closings, immigration, payment of social security and similar Taxes, wages and hours, and employment classification (including as exempt versus non-exempt and employee versus independent contractor). The Company is in compliance in all material respects with any and all employment agreements with Company employees. Except as set forth in Schedule 4.14(a) , no claims, controversies, investigations, audits or other legal proceedings are pending or, to the knowledge of the Company, threatened, with respect to such Laws or employment agreements, either by private persons or by governmental entities that could reasonably be expected to result in material liability to the Company.

(b) The Company is not a party to any collective bargaining agreement with respect to its employees with any labor organization, group or association, and, to the knowledge of the Company, no organizational effort is presently being made or threatened (including the filing of a petition for certification), or has been made or threatened within the past two (2) years, by or on behalf of any labor union with respect to employees of the Company. As of the date of this Agreement, there is no, nor has there within the past two (2) years been any, actual or threatened labor strike, slowdown, claim of unfair labor practice, or work stoppage against the Company.

(c) Schedule 4.14(c) contains a list of all Company employees, along with each Company employee’s position, date of hire, work location (including city, state, and country), annual rate of compensation (or with respect to Company employees compensated on an hourly or per diem basis, the hourly or per diem rate of compensation), job classification (exempt or non-exempt), estimated or target annual incentive compensation, and status of employment (including whether the person is on leave of absence and, if so, the dates of such leave). Except as set forth on Schedule 4.14(c) , there are no material amounts of compensation outstanding (including bonuses, vacation pay and other liabilities accrued through the date hereof) to any employee or former employee of the Company (other than accrued amounts representing salary or bonus entitlements due for the current pay period or for the reimbursement of legitimate business expenses). Each Company employee is retained at-will and no Company employee is a party to an employment agreement except as set forth in Schedule 4.14(c) . Except as set forth on Schedule 4.14(c) , each Company employee may be terminated without any penalty, notice or severance obligation on the part of the Company. Except as set forth on Schedule 4.14(c) , no employee or independent contractor of the Company is eligible to receive any payment or benefit as a result of the transaction contemplated herein. Each Company employee has entered into the Company’s standard form of confidentiality and assignment of inventions agreement, a copy of which has previously been made available to the Buyer. Schedule 4.14(c) contains a list of all Company

employees employed in the United States who are not citizens or permanent residents of the United States and, for each such Company employee, such Company employee’s visa, work authorization, and/or green card status and the date such work authorization is scheduled to expire.

(d) Schedule 4.14(d) contains a list of all consultants and independent contractors currently engaged by the Company, along with the position, initial date of retention and rate of remuneration for each such person. The Company has previously made available to Buyer each of the consultant and independent contractor written agreements or contracts with such individuals. Each consultant and independent contractor has entered into the Company’s standard form of confidentiality and assignment of inventions agreement with the Company, a copy of which has previously been made available to the Buyer. Except as set forth on Schedule 4.14(d) , the Company has not had in the prior two (2) years any temporary or leased employees.

(e) Except as set forth on Schedule 4.14(e) , no charges or complaints are open or pending against the Company with the Equal Employment Opportunity Commission, a state fair employment or practices agency, the National Labor Relations Board, or similar governmental entity or pursuant to internal complaint procedures that could reasonably be expected to result in a material liability to the Company. To the knowledge of the Company, except as set forth on Schedule 4.14(e) , since January 1, 2015, no current or former employee of the Company has complained in writing of discrimination, retaliation or other wrongdoing pertaining to that person’s employment with the Company with respect to any matter that could reasonably be expected to result in a material liability to the Company.

(f) Schedule 4.14(f) (i) contains a complete and accurate list of all of the Company’s written employee handbooks, employment manuals, and employment policies, and (ii) sets forth the policy of the Company with respect to accrued vacation, paid time off, accrued sick time and earned time off.

4.15 Taxes .

(a) Except as set forth in Schedule 4.15(a) , all income and other material Tax Returns required to be filed by or with respect to the Company have been timely filed, and all such Tax Returns are true, complete and accurate in all material respects. The Company is not currently the beneficiary of any extension of time within which to file any Tax Return. No claim has ever been made by a Tax Authority in a jurisdiction where the Company does not file a Tax Return that such entity is or may be subject to taxation by that jurisdiction in respect of Taxes that would be covered by or the subject of such Tax Return.

(b) The Company has paid all income and other material Taxes which are due and payable by the Company. The unpaid Taxes of the Company (A) for taxable periods (or portions thereof) through the date of the Interim Financial Statements do not exceed the accruals and reserves for Taxes (excluding accruals and reserves for deferred Taxes established to reflect timing differences between book and Tax income) set forth on the Interim Financial Statements and (B) for taxable periods (or portions thereof) though the

Closing Date, will not exceed the reserve as adjusted for the passage of time through the Closing Date in accordance with GAAP. All unpaid Taxes of the Company for all taxable periods (or portions thereof) commencing after the date of the Interim Financial Statements arose in the ordinary course of business.

(c) The Company has withheld and paid over to the appropriate Tax Authority all Taxes required to be withheld in connection with any amounts paid or owing to any employee, creditor, independent contractor or other third party, and the Company has complied with all information reporting and backup withholding requirements, including the maintenance of required records with respect thereto.

(d) No material deficiency for any Taxes has been asserted or assessed by any Tax Authority in writing (or, to the knowledge of the Company, otherwise) against the Company (or, to the knowledge of the Company, has been threatened or proposed), except for deficiencies which have been satisfied by payment, settled or withdrawn. No audit or other proceeding by any Tax Authority is pending or threatened in writing (or, to the knowledge of the Company, otherwise) against the Company with respect to any Taxes due from the Company or Tax Returns filed by the Company.

(e) The Company is not a party to or bound by any Tax indemnification or Tax sharing agreements under which the Company would reasonably be expected to be liable after the Closing Date for the Tax liability of any Person that is not the Company, other than customary agreements or arrangements entered into in the ordinary course of business with customers, vendors, lessors, lenders and the like that do not relate primarily to Taxes.

(f) The Company has not been a party to a “listed transaction,” as such term is defined in Treasury Regulations Section 1.6011-4(b)(1), that has not been disclosed in the relevant Tax Return of the Company. The Company has disclosed on its federal income Tax Returns all positions taken therein that could reasonably be expected to give rise to a substantial understatement of federal income Tax within the meaning of Section 6662 of the Code.

(g) The Company is not and has never been a member of an affiliated group with which it has filed (or been required to file) consolidated, combined, unitary or similar Tax Returns, other than a group of which the common parent is the Company. The Company has no liability under Treasury Regulation Section 1.1502-6 (or any comparable or similar provision of federal, state, local or foreign Law), as a transferee or successor, pursuant to any contractual obligation, or otherwise for any Taxes of any Person other than the Company.

(h) The Company has delivered or made available to the Buyer (i) complete and correct copies of all income and other material Tax Returns of the Company relating to Taxes for all taxable periods for which the applicable statute of limitations has not yet expired, (ii) complete and correct copies of all private letter rulings, revenue agent reports, information document requests, notices of proposed deficiencies, deficiency notices, closing agreements, settlement agreements and pending ruling requests submitted by, received by, or agreed to by or on behalf of the Company relating to Taxes

for all taxable periods for which the statute of limitations has not yet expired, and (iii) complete and correct copies of all material agreements, rulings, settlements or other Tax documents with or from any Governmental Authority relating to Tax incentives of the Company.

(i) The Company has not waived any statute of limitations with respect to Taxes or agreed to extend the period for assessment or collection of any Taxes, which waiver or extension is still in effect. The Company has not executed or filed any power of attorney with any Taxing Authority, which is still in effect.

(j) The Company will not be required to include any material item of income in, or exclude any item of deduction from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of (i) any adjustments under Section 481 of the Code (or any similar adjustments under any provision of the Code or the corresponding foreign, state or local Tax Law), (ii) closing agreement as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign Tax Law) executed on or prior to the Closing Date, (iii) installment sale or open transaction disposition made on or prior to the Closing Date, (iv) prepaid amount received on or prior to the Closing Date, or (v) any election made pursuant to Section 108(i) of the Code on or prior to the Closing Date.

(k) The Company has not been a United States real property holding corporation within the meaning of Section 897(c)(2) of the Code during the applicable period specified in Section 897(c)(l)(A)(ii) of the Code.

(l) The Company has not distributed to its shareholders or security holders stock or securities of a controlled corporation, nor has stock or securities of the Company been distributed, in a transaction to which Section 355 of the Code applies (i) in the two years prior to the date of this Agreement or (ii) in a distribution that could otherwise constitute part of a “plan” or “series of related transactions” (within the meaning of Section 355(e) of the Code) that includes the transactions contemplated by this Agreement.

(m) There are no liens or other encumbrances with respect to Taxes upon any of the assets of the Company, other than with respect to Taxes not yet due and payable.

(n) The Company is not (i) a party to any joint venture, partnership, or other arrangement that is treated as a partnership for federal income Tax purposes, (ii) a stockholder of a “specified foreign corporation” as defined in Section 965(e) of the Code (or any similar provision of state, local or foreign Law), or (iii) a stockholder in a “passive foreign investment company” as defined in Section 1297 of the Code.

(o) The Company is not subject to tax in any country other than its country of incorporation, organization or formation by virtue of having employees, a permanent establishment or other place of business in that country.

(p) The Company has no knowledge of any facts, and has not taken or agreed to take any action, that would reasonably be expected to prevent or impede the Merger from

qualifying as a “reorganization” within the meaning of Section 368(a) of the Code or to cause the Merger to be subject to Section 367(a)(1) of the Code.

(q) The Company is not an investment company as defined in Section 368(a)(2)(F)(iii) and (iv) of the Code.

(r) To the knowledge of the Company, the fair market value of the total outstanding equity of Buyer, excluding assets acquired outside the ordinary course of business within the thirty-six (36) month period preceding the Merger (unless such assets are permitted to be taken into account by Treasury Regulations Section 1.367(a)-3(c)(3)(iii)), is at least equal to the fair market value of the total outstanding stock of the Company.

(s) None of the Company’s shareholders will be a five-percent transferee shareholder (as defined in Treasury Regulation Section 1.367(a)-3(c)(5)(ii)) immediately after the Merger.

(t) Notwithstanding anything to the contrary in this Agreement, the representations and warranties in Section 4.13 , Section 4.14 and this Section 4.15 shall be the only representations or warranties of the Company in this Agreement with respect to Tax matters. The representations and warranties in this Section 4.15 (other than Sections 4.15(e) , (g) and (j)) may only be relied upon for purposes of liability for Tax periods (or portions thereof) ending on or prior to the Closing Date and shall not be construed as a representation or warranty with respect to Tax positions that Buyer or any of its Affiliates (including the Company) may take in or in respect of a Tax period beginning after the Closing Date. Nothing in this Section 4.15 or otherwise in this Agreement shall be construed as a representation or warranty with respect to the existence, amount or usability of any net operating loss, capital loss, or Tax credit carryover of the Company in any Tax period beginning after the Closing Date.

4.16 Brokers’ Fees . Except as set forth on Schedule 4.16 , no broker, finder, investment banker or other Person is entitled to any brokerage fee, finders’ fee or other similar commission, for which Buyer or the Company would be liable in connection with the transactions contemplated by this Agreement based upon arrangements made by the Company or any of its Affiliates.

4.17 Insurance . Schedule 4.17 contains a list of all material policies of property, fire and casualty, product liability, workers’ compensation, and other forms of insurance held by, or for the benefit of, the Company as of the date of this Agreement. True and complete copies of such insurance policies have been made available to Buyer or its representatives. Except as set forth in Schedule 4.17 , (a) as of the date hereof, the Company has not received any written notice from any insurer under any such insurance policies, canceling or materially adversely amending any such policy or denying renewal of coverage thereunder and (b) all premiums on such insurance policies due and payable as of the date hereof have been paid.

4.18 Licenses, Permits and Authorizations . Except as set forth on Schedule 4.18 , the Company holds, and, to the Company’s knowledge, is in compliance in all material respects with, all of the material licenses, approvals, consents, registrations and permits issued by Governmental Authorities, including the FDA, that are required by applicable Laws to permit the Company to

own, operate, use and maintain its assets in the manner in which they are now operated, used and maintained and to conduct the business of the Company (collectively, the “ Company Permits ”). There are no pending or, to the knowledge of the Company, threatened claims, actions, suits or other proceedings or, to the knowledge of the Company, investigations before or by any Governmental Authority that would reasonably be expected to result in the revocation or termination of any such material Company Permit.

4.19 Real Property . Schedule 4.19 lists, as of the date of this Agreement, all Leased Real Property. Except as set forth on Schedule 4.19 , (i) the Company has a valid and enforceable leasehold estate in, and enjoys peaceful and undisturbed possession of, all Leased Real Property, subject to the Remedies Exception and any Permitted Liens; (ii) the Company has not received any written notice from any lessor of such Leased Real Property of, nor does the Company have knowledge of the existence of, any default, event or circumstance that, with notice or lapse of time, or both, would constitute a material default by the party that is the lessee or lessor of such Leased Real Property; (iii) neither the Company nor any Subsidiary has assigned, transferred, conveyed, mortgaged, subleased, licensed, or encumbered any interest in the leasehold or subleasehold; (iv) all facilities leased or subleased thereunder are supplied with utilities and other services adequate for the operation of said facilities in the manner in which they are currently operated. The Company owns no real property.

4.20 Intellectual Property .

(a) Schedule 4.20(a) lists (i) each Patent Right (A) that is in the Company Owned Intellectual Property or (B) that is in the Company Licensed Intellectual Property with respect to which the Company has a right to participate in the prosecution or maintenance, and (ii) each trademark, service mark, domain name and copyright owned by the Company, in each case for which applications have been filed or registrations or issued patents have been obtained, whether in the United States or in any country internationally (all of the items to be listed on Schedule 4.20(a) , the “ Company Registered IP ”), in each case enumerating specifically the applicable filing or registration number, title, jurisdiction in which filing was made or from which registration issued, date of filing and issuance, names of all current applicant(s) and registered owners(s), as applicable. To the knowledge of the Company, the Company has made all filings and payments required to be made to maintain each item of such registered or issued Intellectual Property, and for all applications in Company Registered IP, in full force and effect by the applicable deadline and otherwise in accordance with all applicable Laws. All assignments to the Company of Company Registered IP that is Company Owned Intellectual Property have been properly executed and recorded.

(b) No inventorship challenge, opposition, nullity proceeding, inter partes review, post grant review proceeding or interference has been filed, or to the knowledge of the Company, threatened, with respect to any Patent Rights included in the Company Registered IP. The Company has complied with its duty of candor and disclosure to the United States Patent and Trademark Office and any relevant foreign patent office with respect to all patent and trademark applications in the Company Registered IP filed by or on behalf of the Company and have made no material misrepresentation in such applications. To the Company’s knowledge, the Company has clear title to the Company

Registered IP that is Company Owned Intellectual Property. To the Company’s knowledge, there has been no public disclosure of any Intellectual Property subject to registration in any Company Registered IP that is Company Owned Intellectual Property, including in trade publications or at trade shows, prior to filing of such Company Registered IP.

(c) Except as set forth on Schedule 4.20(c) , to the knowledge of the Company, the Company owns (free and clear of all Liens), or has the right to use pursuant to license, sublicense, agreement or permission as set forth in a Contract set forth in Schedule 4.12 , (i) (A) all Company Registered IP, and (B) (1) all other Company Intellectual Property, and any tangible embodiments thereof, used by or on behalf of the Company in researching, developing, manufacturing or commercializing the Company Milestone Product and (2) all other material Company Intellectual Property, and any tangible embodiments thereof, used in the operation of the business of the Company, in the case of (1) or (2), as presently conducted or as conducted at any time within the last three (3) years or as currently contemplated to be conducted.

(d) Except as set forth on Schedule 4.20(d) , the Company has not received from any Person in the past three (3) years any written notice, charge, complaint, claim or other written assertion of any direct or indirect infringement, violation or misappropriation of any Intellectual Property of any Person by the Company. To the knowledge of the Company, neither the Exploitation of any of the Company Regulated Products, nor any other activity by the Company, has infringed or violated, or constituted a misappropriation of, any Intellectual Property rights of any third party.

(e) To the knowledge of the Company, no third party (including any current or former employee, consultant or contractor of the Company) is infringing upon, misappropriating or otherwise violating any Company Intellectual Property, except for any such infringement that, individually or in the aggregate, would not reasonably be expected to result in material liability to the Company or Buyer.

(f) To the knowledge of the Company, neither the execution, delivery, or performance of this Agreement nor the consummation of any of the transactions or agreements contemplated by this Agreement will result in (i) any loss, termination or impairment of, or any change in the Company’s rights in, any Company Intellectual Property, (ii) a breach of or default under any Contract governing any Company Intellectual Property, (iii) the grant or transfer to any third party of any new license or other right or interest under, the abandonment, assignment to any third party, the modification or loss of any right with respect to, or the creation of any Lien on, any Company Intellectual Property, or (iv) the Company, the Buyer or any of Buyer’s Affiliates (including the Final Surviving Corporation) being obligated to pay any penalty or new or increased royalty or fee to any Person under any Contract governing any Company Intellectual Property.

(g) The Company has used commercially reasonable efforts to maintain in confidence the trade secrets and other confidential information in the Company Intellectual Property. The Company has complied in all material respects with all

applicable Contracts and Laws pertaining to information privacy, data protection or security, including the Health Insurance Portability and Accountability Act of 1996, the EU Data Protection Directive and any Laws in any country relating thereto, and the General Data Protection Regulation and any Laws in any country relating thereto. No complaint relating to an improper use or disclosure of, or a breach in the security of, any trade secrets, confidential information or protected information has been made or, to the knowledge of the Company, threatened against the Company. To the knowledge of the Company, there has been no (i) unauthorized disclosure of any third party proprietary or confidential information in the possession, custody or control of the Company, or (ii) breach of the Company’s security procedures wherein confidential information has been disclosed to a third party.

(h) Each individual who is or was an employee or independent contractor of the Company has executed a valid, binding and enforceable written agreement expressly and presently assigning to the Company all right, title and interest in any inventions, works of authorship and data invented, conceived, reduced to practice, authored, created or otherwise developed, during the term of such individual’s employment or such independent contractor’s work for the Company, and all Intellectual Property rights therein, and has waived all moral rights therein to the extent legally permissible.

(i) Schedule 4.20(i) sets forth (i) all Company Intellectual Property that is subject to the Bayh-Dole Act or a comparable Law outside the United States or any other Law granting any Governmental Authority any license, retained right or march-in right with respect to such Intellectual Property or any right as a result of funding by a Governmental Authority and (ii) each Contract pursuant to which such Company Intellectual Property is subject to such Law. Except as set forth on Schedule 4.20(i) , neither the Company, or any assignor or licensor to the Company, has received any support, funding, resources or assistance from any Governmental Authority or quasi-governmental agency or funding source in connection with the Exploitation of any Company Regulated Product, any facilities or equipment used in connection therewith or any Company Intellectual Property. No university or Governmental Authority has sponsored any research or development conducted by or on behalf of the Company, or has any claim of right or ownership of or Lien on any Company Intellectual Property.

4.21 Environmental Matters . Except as set forth on Schedule 4.21 , the Company is (and has been for the last three (3) years) in compliance with all Environmental Laws, except for any such instance of noncompliance that would not reasonably be expected to have a Material Adverse Effect on the Company. Except as set forth on Schedule 4.21 , the Company holds, and is (and has been for the last three (3) years) in material compliance with, all Company Permits required under applicable Environmental Laws to permit the Company to operate its assets in a manner in which it is now operated and maintained and to conduct the business of the Company as currently conducted, except where the absence of, or the failure to be in material compliance with, any such permit could reasonably be expected to result in material liability to the Company. Except as set forth on Schedule 4.21 , there are no written claims or notices of violation pending or, to the knowledge of the Company, threatened against the Company alleging violations of or liability under any Environmental Law, except for any such claim or notice that could reasonably be expected to result in material liability to the Company. This Section 4.21 provides the sole and

exclusive representations and warranties of the Company in respect of environmental matters, including any and all matters arising under Environmental Laws.

4.22 Absence of Changes .

(a) Except as set forth on Schedule 4.22 , from December 31, 2017 to the date of this Agreement, there has not been any Material Adverse Effect on the Company.

(b) Except as set forth on Schedule 4.22 or as expressly contemplated by this Agreement, from the date of the most recent balance sheet included in the Financial Statements through the date of this Agreement, the Company has, in all material respects, conducted its business and operated its properties in the ordinary course of business consistent with past practice.

(c) Except as set forth on Schedule 4.22 , from the date of the most recent balance sheet included in the Financial Statements through the date of this Agreement, the Company has not taken any of the actions set forth in Section 6.1 .

4.23 Affiliate Matters. Except (a) as set forth on Schedule 4.23 and (b) the Company Benefit Plans, the Company is not party to any Contract with any (i) present or former officer or director of the Company or (ii) Affiliate of the Company. No Affiliate of the Company, directly or indirectly, (a) owns any property or right, tangible or intangible, which is used in the business of the Company, (b) to the knowledge of the Company, has any claim or cause of action against the Company, or (c) other than employment-related arrangements and the payment of compensation and benefits in the ordinary course of business and travel advances and employee loans in the ordinary course, owes any money to, or is owed any money by, the Company.

4.24 No Outside Reliance . Notwithstanding anything contained in this Article IV or any other provision hereof, the Company acknowledges and agrees that neither the Buyer, nor either Merger Sub nor any of their Affiliates, nor any of its or their respective directors, officers, employees, stockholders, partners, members, agents or representatives, has made, or is making, any representation or warranty whatsoever, express or implied (and the Company has not relied on any representation, warranty or statement of any kind by Buyer or either Merger Sub or any of their Affiliates or any of their respective directors, officers, employees, stockholders, partners, members, agents or representatives), beyond those expressly given in Article IV , including any implied warranty or representation as to condition, merchantability, suitability or fitness for a particular purpose or trade as to any of the assets of the Buyer or either Merger Sub. Without limiting the generality of the foregoing, it is understood that any cost estimates, financial or other projections or other predictions that may be contained or referred to in the Buyer SEC Documents, the Disclosure Schedules or elsewhere, as well as any information, documents or other materials (including any such materials contained in any “data room” or reviewed by the Company or any of its Affiliates, agents or representatives pursuant to the Confidentiality Agreement) or management presentations that have been or shall hereafter be provided to the Company or any of its Affiliates, agents or representatives are not and will not be deemed to be representations or warranties of Buyer or either Merger Sub, and no representation or warranty is made as to the accuracy or completeness of any of the foregoing, except as may be expressly set forth in Article IV .

4.25 Unaccredited Investors . There are no more than 35 Pre-Closing Holders that are not Accredited Investors.

4.26 No Additional Representations or Warranties . Except as provided in this Article IV , neither the Company nor any of its Affiliates, nor any of their respective directors, officers, employees, stockholders, partners, members or representatives has made, or is making, any representation or warranty whatsoever to Buyer or either Merger Sub or their respective Affiliates, respective directors, officers, employees, stockholders, partners, members or representatives, and no such party shall be liable in respect of the accuracy or completeness of any information provided to Buyer or either Merger Sub or their respective Affiliates, directors, officers, employees, stockholders, partners, members or representatives.

ARTICLE V.
REPRESENTATIONS AND WARRANTIES OF BUYER AND MERGER SUBS

Except: (a) as disclosed in the Buyer SEC Documents at least two (2) Business Days prior to the date hereof, and that is reasonably apparent on the face of such disclosure to be applicable to the representation and warranty set forth herein (other than any disclosures contained or referenced therein under the captions “Risk Factors,” “Forward-Looking Statements,” “Quantitative and Qualitative Disclosures About Market Risk,” but including any historical statements in such sections, and any other disclosures contained or referenced therein of information, factors, or risks that are predictive, cautionary, or forward-looking in nature); or (b) as set forth in the correspondingly numbered Section of the Disclosure Schedules; Buyer, Merger Sub I and Merger Sub II hereby jointly and severally represent and warrant to the Company as follows:

5.1 Corporate Organization . Buyer has been duly incorporated and is validly existing as a public limited company under the Laws of Ireland. Merger Sub I has been duly incorporated and is validly existing as a corporation in good standing under the Laws of the State of Delaware. Merger Sub II has been duly incorporated and is validly existing as a corporation in good standing under the Laws of the State of Delaware. Merger Sub I is a corporation newly formed for the sole purpose of effecting the First Merger, and has not engaged in any activity other than as contemplated in this Agreement. Each of Buyer and each of the Merger Subs has the requisite power and authority to own or lease its properties and to conduct its business as it is now being conducted. The copies of the organizational documents of each of Buyer and Merger Subs previously delivered by Buyer to the Company and as most recently filed with the Buyer SEC Documents are true and complete. Each of Buyer and each of the Merger Subs is duly licensed or qualified and (where applicable) in good standing in each jurisdiction in which the ownership of its property or the character of its activities is such as to require it to be so licensed or qualified or in good standing, as applicable, except where failure to be so licensed or qualified or in good standing would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries. Buyer owns, beneficially and of record, all of the outstanding shares of capital stock of each of the Merger Subs, free and clear of all Liens.

5.2 Subsidiaries . Each Subsidiary of the Buyer, along with its jurisdiction of incorporation, formation or organization, (including each entity that has been a Subsidiary of the Buyer within the prior two (2) years), as well as the jurisdiction of incorporation, formation or organization of

each entity, is set forth in Schedule 5.2 . Each of such Subsidiaries is a legal entity that has been duly formed and is validly existing, and where applicable, as an entity in good standing under the Laws of its jurisdiction of formation.

5.3 Due Authorization . Each of Buyer, Merger Sub I and Merger Sub II has all requisite power and authority to execute and deliver this Agreement and (subject to the consents, approvals, authorizations and other requirements described in Section 5.5 ) to perform all obligations to be performed by it hereunder. The execution and delivery of this Agreement by Buyer, Merger Sub I and Merger Sub II and the consummation by them of the transactions contemplated hereby have been duly and validly authorized and approved by the boards of directors of each of Buyer, Merger Sub I and Merger Sub II, and no other corporate proceeding on the part of Buyer, Merger Sub I or Merger Sub II is necessary to authorize this Agreement (other than the adoption of this Agreement by Buyer in its capacity as the sole stockholder of Merger Sub I and Merger Sub II, which adoption will occur immediately following the execution of this Agreement by Merger Subs). This Agreement has been duly and validly executed and delivered by each of Buyer and Merger Subs and (assuming this Agreement constitutes a legal, valid and binding obligation of the Company and the Stockholder Representative) constitutes a legal, valid and binding obligation of each of Buyer and Merger Subs, enforceable against Buyer and Merger Subs in accordance with its terms, subject to the Remedies Exception.

5.4 No Conflict. Except as set forth on Schedule 5.4 , and subject to the receipt of the consents, approvals, authorizations and other requirements set forth in Section 5.5 or on Schedule 5.5 the execution and delivery of this Agreement by Buyer and Merger Subs and the consummation by them of the transactions contemplated hereby do not and will not, as of the Closing, (a) violate any provision of, or result in the breach of any applicable Law to which Buyer or either Merger Sub is subject or by which any property or asset of Buyer or either Merger Sub is bound, (b) conflict with or violate any provision of the certificate of incorporation, bylaws or other organizational documents of Buyer or any Subsidiary of Buyer (including either Merger Sub), (c) violate any provision of or result in a breach of, or require a consent or constitute (with or without due notice or lapse of time or both) under, any agreement, indenture or other instrument to which Buyer or any Subsidiary of Buyer (including either Merger Sub) is a party or by which Buyer or any Subsidiary of Buyer (including either Merger Sub) may be bound, or terminate or result in the termination of any such agreement, indenture or instrument, or result in the creation of any Lien under any such agreement, indenture or instrument upon any of the properties or assets of Buyer or any Subsidiary of Buyer (including either Merger Sub), or constitute an event which, after notice or lapse of time or both, would result in any such violation, breach, termination or creation of a Lien or create in any party the right to accelerate or modify such Contract, or (d) result in a violation or revocation of any required license, permit or approval from any Governmental Authority, except to the extent that the occurrence of the foregoing items set forth in clauses (a), (c) or (d) would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries.

5.5 Governmental Consents . Assuming the truth and completeness of the representations and warranties of the Company contained in this Agreement, no consent, approval or authorization of, or designation, declaration or filing with, any Governmental Authority is required on the part of Buyer or Merger Subs with respect to Buyer’s or either Merger Subs’ execution or delivery of this Agreement or the consummation by Buyer or Merger Subs of the transactions contemplated

hereby, except for (a) any consents, approvals, authorizations, designations, declarations or filings, the absence of which would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries, (b) compliance with any applicable securities Laws, (c) as otherwise disclosed on Schedule 5.5 , (d) in the case of Merger Sub I, the filing of the Certificate of Merger in accordance with the DGCL and (e) in the case of Merger Sub II, the filing of the Second Certificate of Merger in accordance with the DGCL.

5.6 Capitalization of Buyer .

(a) The authorized share capital (collectively, the “ Buyer Share Capital ”) of Buyer consists of:

(i) 1,000,000,000 Buyer Ordinary Shares, 40,965,435 of which are issued and outstanding as of July 20, 2018 (the “ Capitalization Date ”).

(ii) 25,000 Euro deferred shares of €1.00 each, none of which are issued and outstanding as of the Capitalization Date.

(iii) 100,000,000 preferred shares of US$0.01 each, none of which are issued and outstanding as of the Capitalization Date.

All of the issued and outstanding shares of Buyer Share Capital have been duly authorized and validly issued and are fully paid and nonassessable and have not been issued in violation of any preemptive or similar rights. All of the issued and outstanding shares of capital stock of the Buyer have been offered, issued and sold by the Buyer in material compliance with all applicable federal and state securities Laws.

(b) As of the Capitalization Date, 4,896,520 Buyer Ordinary Shares are subject to outstanding options to purchase Buyer Ordinary Shares and 328,300 Buyer Ordinary Shares are subject to outstanding restricted stock units issued by Buyer.

(c) Except (i) as set forth in this Section 5.6 or (ii) as set forth on Schedule 5.6 , the Buyer has not granted any outstanding options, warrants, rights or other securities convertible into or exchangeable or exercisable for shares of Buyer Share Capital, or any other commitments or agreements providing for the issuance of additional shares, the sale of treasury shares, or for the repurchase or redemption of Buyer Ordinary Shares, and there are no agreements of any kind which may obligate Buyer to issue, purchase, register for sale, redeem or otherwise acquire any of its capital stock.

5.7 Financial Statements . Each of the consolidated financial statements (including, in each case, any notes and schedules thereto) contained in or incorporated by reference into the Buyer SEC Documents (“ Buyer Financial Statements ”): (i) complied as to form in all material respects with the published rules and regulations of the SEC with respect thereto as of their respective dates; (ii) was prepared in accordance with GAAP applied on a consistent basis throughout the periods involved (except as may be indicated in the notes thereto and, in the case of unaudited interim financial statements, as may be permitted by the SEC for quarterly reports on Form 10-Q); and (iii) fairly presented in all material respects the consolidated financial position and the results of operations, changes in stockholders’ equity, and cash flows of the Buyer and its consolidated

Subsidiaries as of the respective dates of and for the periods referred to in such financial statements, subject, in the case of unaudited interim financial statements, to normal and year-end audit adjustments as permitted by GAAP and the applicable rules and regulations of the SEC (but only if the effect of such adjustments would not, individual or in the aggregate, be material).

5.8 Undisclosed Liabilities . Except as set forth on Schedule 5.8 , as of the date of this Agreement, there is no liability, debt or obligation of the Buyer or any of its Subsidiaries, except for liabilities and obligations (a) reflected or reserved for on the Buyer Financial Statements or disclosed in the notes thereto, (b) that have arisen since the date of the most recent balance sheet included in the Buyer Financial Statements in the ordinary course of the operation of business of the Buyer, (c) disclosed in the Buyer’s Disclosure Schedules or (d) contractual and other liabilities incurred in the ordinary course of business of the Buyer that are not required by GAAP to be reflected on a balance sheet and that are not in the aggregate material (in each case, none of which results from, arises out of, relates to, is in the nature of, or was caused by any breach of contract, breach of warranty, tort, infringement or violation of Law).

5.9 Litigation and Proceedings . Except as set forth on Schedule 5.9 , as of the date of this Agreement, there are no pending or, to the knowledge of Buyer, threatened, lawsuits, actions, suits, claims or other proceedings at law or in equity or, to the knowledge of the Buyer, investigations, in each case, before or by any Governmental Authority against the Buyer or any of its Subsidiaries that, in each case, if resolved adversely to the Buyer, would reasonably be expected to have a Material Adverse Effect on Buyer or any of its material Subsidiaries.

5.10 Compliance with Laws . Buyer and each of its Subsidiaries are in compliance with all applicable Laws, except where the failure to be in compliance with such Laws would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries. As of the date hereof, neither Buyer nor any of its Subsidiaries has received any written notice from any Governmental Authority (including the FDA) of a material violation of any applicable Law at any time during the past two (2) years that would reasonably be expected to have a Material Adverse Effect on Buyer or any of its material Subsidiaries.

5.11 FDA Matters .

(a) As to each of the product candidates of each of the Buyer and its Subsidiaries, including compounds currently under research and/or development by the Company and subject to the jurisdiction of the FDA or any equivalent Governmental Authority in any legal jurisdiction other than the U.S. (each such product, a “ Buyer Regulated Product ”), such Buyer Regulated Product is being researched, developed, manufactured, stored and tested in compliance in all material respects with all applicable Laws. During the past two (2) years, neither the Buyer nor any of its Subsidiaries has received any written notice or other written communication from any Governmental Authority alleging any material violation by the Company of any Law applicable to a Buyer Regulated Product.

(b) To the knowledge of the Buyer, neither Buyer nor any of its Subsidiaries has made any untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Authority or otherwise failed to disclose a material fact required to be disclosed to the FDA or any Governmental Authority.

(c) All preclinical studies and clinical trials, and other studies and tests of any Buyer Regulated Product conducted by or on behalf of the Buyer or any of its Subsidiaries have been, and if still pending are being, conducted in material compliance, to the extent applicable with all applicable Laws, including the FDCA and its implementing regulations governing good laboratory practices and good clinical practices, and the respective counterparts thereof outside the United States. All clinical trials conducted by or for the benefit of the Company have been in the past three (3) years, and are being, conducted in material compliance with all applicable Laws, including, without limitation, 21 C.F.R. Parts 50, 54, 56, and 312 of the U.S. Code of Federal Regulations. No clinical trial conducted by or on behalf of the Buyer or any of its Subsidiaries has been terminated or placed on clinical hold by the FDA for safety reasons prior to scheduled completion, and neither the FDA nor any other applicable Governmental Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Buyer or any of its Subsidiaries has initiated, or, to the Buyer’s knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation of the Buyer Regulated Products conducted or proposed to be conducted by or on behalf of the Buyer or any of its Subsidiaries, and any other standards comprising good clinical practices.

(d) All documents filed by the Company with the FDA or any other Governmental Authority with respect to the Buyer Regulated Products, or the manufacturing, handling, storage or shipment of the Buyer Regulated Products were, at the time of filing, true, complete and accurate in all material respects.

(e) Neither the Buyer nor any of its Subsidiaries has received any written notice that the FDA or any other Governmental Authority has commenced, or, to the Buyer’s knowledge, threatened in writing to initiate, any action to enjoin production of the Buyer Regulated Products at any of its or its suppliers’ facilities.

(f) None of the Buyer, any of its Subsidiaries nor, to the knowledge of the Buyer, any officer, employee or agent of the Buyer or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has caused or would reasonably be expected to result in (A) disqualification or debarment by the FDA under 21 U.S.C. Section 335a, or any similar law, rule or regulation of any other Governmental Authority, or (B) exclusion from federal health care programs under 42 U.S.C. Sections 1320a-7 or 1320a-7a, or any similar law, rule or regulation of any Governmental Authority.

(g) In the past three (3) years, neither the Buyer nor any of its Subsidiaries has received from any Governmental Authority (i) any warning letters, untitled letters, or similar written correspondence alleging material noncompliance by the Buyer or any of its Subsidiaries with applicable Laws, or (ii) any unresolved inspection reports and Form FDA 483s identifying material noncompliance with the FDCA. To the knowledge of the Buyer, neither FDA nor any other Governmental Authority intends to bring any such action against the Buyer and its Subsidiary.

5.12 Contracts; No Defaults . Except as set forth on Schedule 5.12 , as of the date of this Agreement, all of the “material contracts” (as such term is defined in Item 601(b)(10) of Regulation S-K of the Securities Act), whether or not filed by Buyer with the SEC, are (i) in full force and effect, subject to the Remedies Exception, and (ii) represent the valid and binding obligations of Buyer or its Subsidiary or Subsidiaries party thereto and, to the knowledge of Buyer, represent the valid and binding obligations of the other parties thereto. Except as set forth on Schedule 5.12 , and except, in each case, where the occurrence of such breach or default would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries, (x) none of Buyer, any of its Subsidiaries or, to the knowledge of Buyer, any other party thereto is in breach of or default under any such Contract, (y) as of the date of this Agreement, neither Buyer nor any of its Subsidiaries has received any claim or notice of breach of or default under any such Contract, and (z) to the knowledge of the Buyer, no event has occurred which, individually or together with other events, would reasonably be expected to result in a breach of or a default under any such Contract (in each case, with or without notice or lapse of time or both).

5.13 Taxes . Except as set forth on Schedule 5.13 :

(a) All income and other material Tax Returns required to be filed by or with respect to Buyer have been timely filed, and all such Tax Returns are true, complete and accurate in all material respects. Buyer is not currently the beneficiary of any extension of time within which to file any Tax Return. No claim has ever been made by a Tax Authority in a jurisdiction where Buyer does not file a Tax Return that such entity is or may be subject to taxation by that jurisdiction in respect of Taxes that would be covered by or the subject of such Tax Return.

(b) Buyer has paid all income and other material Taxes which are due and payable by Buyer. The unpaid Taxes of Buyer (A) for taxable periods (or portions thereof) through the date of the Buyer Financial Statements do not exceed the accruals and reserves for Taxes (excluding accruals and reserves for deferred Taxes established to reflect timing differences between book and Tax income) set forth on the Buyer Financial Statements and (B) for taxable periods (or portions thereof) though the Closing Date, will not exceed the reserve as adjusted for the passage of time through the Closing Date in accordance with GAAP. All unpaid Taxes of Buyer for all taxable periods (or portions thereof) commencing after the date of the Buyer Financial Statements arose in the ordinary course of business.

(c) Buyer has withheld and paid over to the appropriate Tax Authority all Taxes required to be withheld in connection with any amounts paid or owing to any employee, creditor, independent contractor or other third party, and Buyer has complied with all information reporting and backup withholding requirements, including the maintenance of required records with respect thereto.

(d) No material deficiency for any Taxes has been asserted or assessed by any Tax Authority in writing (or, to the knowledge of Buyer, otherwise) against Buyer (or, to the knowledge of Buyer, has been threatened or proposed), except for deficiencies which have been satisfied by payment, settled or withdrawn. No audit or other proceeding by any Tax Authority is pending or threatened in writing (or, to the knowledge of Buyer,

otherwise) against Buyer with respect to any Taxes due from Buyer or Tax Returns filed by Buyer.

(e) Buyer is not a party to or bound by any Tax indemnification or Tax sharing agreements under which Buyer would reasonably be expected to be liable after the Closing Date for the Tax liability of any Person that is not Buyer, other than customary agreements or arrangements entered into in the ordinary course of business with customers, vendors, lessors, lenders and the like that do not relate primarily to Taxes.

(f) Buyer has not been a party to a “listed transaction,” as such term is defined in Treasury Regulations Section 1.6011-4(b)(1), that has not been disclosed in the relevant Tax Return of Buyer. Buyer has disclosed on its federal income Tax Returns all positions taken therein that could reasonably be expected to give rise to a substantial understatement of federal income Tax within the meaning of Section 6662 of the Code.

(g) Buyer is not and has never been a member of an affiliated group with which it has filed (or been required to file) consolidated, combined, unitary or similar Tax Returns, other than a group of which the common parent is Buyer. Buyer has no liability under Treasury Regulation Section 1.1502-6 (or any comparable or similar provision of federal, state, local or foreign Law), as a transferee or successor, pursuant to any contractual obligation, or otherwise for any Taxes of any Person other than Buyer.

(h) Buyer has delivered or made available to the Company (i) complete and correct copies of all income and other material Tax Returns of Buyer relating to Taxes for all taxable periods for which the applicable statute of limitations has not yet expired, (ii) complete and correct copies of all private letter rulings, revenue agent reports, information document requests, notices of proposed deficiencies, deficiency notices, closing agreements, settlement agreements, and pending ruling requests submitted by, received by, or agreed to by or on behalf of Buyer relating to Taxes for all taxable periods for which the statute of limitations has not yet expired, and (iii) complete and correct copies of all material agreements, rulings, settlements or other Tax documents with or from any Governmental Authority relating to Tax incentives of Buyer.

(i) Buyer has not waived any statute of limitations with respect to Taxes or agreed to extend the period for assessment or collection of any Taxes, which waiver or extension is still in effect. Buyer has not executed or filed any power of attorney with any Taxing Authority, which is still in effect.

(j) Buyer will not be required to include any material item of income in, or exclude any item of deduction from, taxable income for any taxable period (or portion thereof) ending after the Closing Date as a result of (i) any adjustments under Section 481 of the Code (or any similar adjustments under any provision of the Code or the corresponding foreign, state or local Tax Law), (ii) closing agreement as described in Section 7121 of the Code (or any corresponding or similar provision of state, local or foreign Tax Law) executed on or prior to the Closing Date, (iii) installment sale or open transaction disposition made on or prior to the Closing Date, (iv) prepaid amount received on or prior to the Closing Date, or (v) any election made pursuant to Section 108(i) of the Code on or prior to the Closing Date.

(k) Buyer has not been a United States real property holding corporation within the meaning of Section 897(c)(2) of the Code during the applicable period specified in Section 897(c)(l)(A)(ii) of the Code.

(l) Buyer has not distributed to its shareholders or security holders stock or securities of a controlled corporation, nor has stock or securities of Buyer been distributed, in a transaction to which Section 355 of the Code applies (i) in the two years prior to the date of this Agreement or (ii) in a distribution that could otherwise constitute part of a “plan” or “series of related transactions” (within the meaning of Section 355(e) of the Code) that includes the transactions contemplated by this Agreement.

(m) There are no liens or other encumbrances with respect to Taxes upon any of the assets of Buyer, other than with respect to Taxes not yet due and payable.

(n) Buyer is not (i) a party to any joint venture, partnership, or other arrangement that is treated as a partnership for federal income Tax purposes, (ii) a stockholder of a “specified foreign corporation” as defined in Section 965(e) of the Code (or any similar provision of state, local or foreign Law), or (iii) a stockholder in a “passive foreign investment company” as defined in Section 1297 of the Code.

(o) Buyer is not subject to tax in any country other than its country of incorporation, organization or formation by virtue of having employees, a permanent establishment or other place of business in that country.

(p) Buyer has no knowledge of any facts, and has not taken or agreed to take any action, that would reasonably be expected to prevent or impede the Merger from qualifying as a “reorganization” within the meaning of Section 368(a) of the Code or to cause the Merger to be subject to Section 367(a)(1) of the Code.

(q) Buyer is not an investment company as defined in Section 368(a)(2)(F)(iii) and (iv) of the Code.

(r) The Buyer Ordinary Shares to be issued pursuant to this Agreement (including the Holdback Shares) do not represent more than 50% of the total voting power or the total value of the stock of Buyer determined as of the Closing Date.

(s) For the entire thirty-six (36) month period immediately preceding the Merger, Buyer or any qualified subsidiary (as defined in Treasury Regulation Section 1.367(a)-3(c)(5)(vii)) or a qualified partnership (as defined in Treasury Regulation Section 1.367(a)-3(c)(5)(viii)) has been engaged in an active trade or business outside the United States consisting of research and development activities, and Buyer’s revenue has consisted principally of governmental research premiums, non-refundable government grants and government loans at below-market interest rates. Buyer has no plan or intention to following the Merger substantially dispose of or discontinue (or to allow any qualified subsidiary or qualified partnership to substantially dispose of or discontinue) the active trade or business referenced in the preceding sentence.

(t) To the knowledge of Buyer, the fair market value of the total outstanding equity

of Buyer, excluding assets acquired outside the ordinary course of business within the thirty-six (36) month period preceding the Merger (unless such assets are permitted to be taken into account by Treasury Regulations Section 1.367(a)-3(c)(3)(iii)), is at least equal to the fair market value of the total outstanding stock of the Company.

(u) Notwithstanding anything to the contrary in this Agreement, the representations and warranties in Section 5.13 shall be the only representations or warranties of Buyer in this Agreement with respect to Tax matters. The representations and warranties in this Section 5.13 (other than Sections 5.13(e) , (g), and (j)) may only be relied upon for purposes of liability for Tax periods (or portions thereof) ending on or prior to the Closing Date and shall not be construed as a representation or warranty with respect to Tax positions that the Buyer, the Company or any of its Affiliates may take in or in respect of a Tax period beginning after the Closing Date. Nothing in this Section 5.13 or otherwise in this Agreement shall be construed as a representation or warranty with respect to the existence, amount or usability of any net operating loss, capital loss, or Tax credit carryover of Buyer in any Tax period beginning after the Closing Date.

5.14 Brokers’ Fees . Except for fees described on Schedule 5.14 (which fees shall be the sole responsibility of Buyer), no broker, finder, investment banker or other Person is entitled to any brokerage fee, finders’ fee or other similar commission in connection with the transactions contemplated by this Agreement based upon arrangements made by Buyer or any of its Affiliates.

5.15 Licenses, Permits and Authorizations . Except as set forth on Schedule 5.15 , Buyer and each of its Subsidiaries holds, and, to the knowledge of the Buyer is, in compliance in all material respects with, all of the material licenses, approvals, consents, registrations and permits issued by Governmental Authorities, including the FDA, that are required by applicable Laws to permit the Buyer or any of its Subsidiaries to own, operate, use and maintain its assets in the manner in which they are now operated, used and maintained and to conduct the business of Buyer or any of its Subsidiaries as currently conducted (collectively, the “ Buyer Permits ”), There are no pending or, to the knowledge of Buyer, threatened claims, actions, suits or other proceedings or, to the knowledge of Buyer, investigations before or by any Governmental Authority that would reasonably be expected to result in the revocation or termination of any such Buyer Permit.

5.16 Intellectual Property .

(a) To the knowledge of Buyer, Buyer and each of its Subsidiaries have made all filings and payments required to be made to maintain each item of registered or issued Intellectual Property owned by Buyer and each of its Subsidiaries in full force and effect by the applicable deadline and otherwise in accordance with all applicable Laws.

(b) Except as set forth on Schedule 5.16 , to the knowledge of Buyer, Buyer or its Subsidiaries, as applicable, own or have the right to use pursuant to license, sublicense, agreement or permission all Intellectual Property used in the operation of the business of Buyer and each of its Subsidiaries, as presently conducted, except where the failure to have such rights would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries.

(c) Except as set forth on Schedule 5.16 , or except as would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries, as of the date of this Agreement, neither Buyer nor any of its Subsidiaries has received from any Person in the past twelve (12) months any written notice, charge, complaint, claim or other written assertion of any infringement or violation by, or misappropriation of, any Intellectual Property of any Person by Buyer or any of its Subsidiaries.

(d) To the knowledge of Buyer, no third party is infringing upon, misappropriating or otherwise violating any Intellectual Property owned by Buyer or any of its Subsidiaries, except as would not reasonably be expected to have a Material Adverse Effect on Buyer or any of its Subsidiaries.

(e) To the knowledge of Buyer, neither the execution, delivery, or performance of this Agreement nor the consummation of any of the transactions or agreements contemplated by this Agreement will result in the loss, termination or impairment of any Intellectual Property owned by Buyer or any of its Subsidiaries that is used in the operation of the business of Buyer or any of its Subsidiaries, as presently conducted.

5.17 Environmental Matters . Except as set forth on Schedule 5.17 , Buyer is (and has been for the last three (3) years) in compliance with all Environmental Laws, except for any such instance of noncompliance that would not reasonably be expected to have a Material Adverse Effect on Buyer. Except as set forth on Schedule 5.17 , Buyer holds, and is (and has been for the last three (3) years) in material compliance with, all Buyer Permits required under applicable Environmental Laws to permit the Company to operate its assets in a manner in which it is now operated and maintained and to conduct the business of the Company as currently conducted, except where the absence of, or the failure to be in material compliance with, any such permit could reasonably be expected to result in material liability to Buyer. Except as set forth on Schedule 5.17 , there are no written claims or notices of violation pending or, to the knowledge of Buyer, threatened against Buyer alleging violations of or liability under any Environmental Law, except for any such claim or notice that could reasonably be expected to result in material liability to Buyer. This Section 5.17 provides the sole and exclusive representations and warranties of Buyer in respect of environmental matters, including any and all matters arising under Environmental Laws.

5.18 Absence of Changes .

(a) Except as set forth on Schedule 5.18 , from December 31, 2017 to the date of this Agreement, there has not been any Material Adverse Effect on Buyer or any of its Subsidiaries.

(b) Except as set forth on Schedule 5.18 , from the date of the most recent balance sheet set forth in the Buyer Financial Statements to the date of this Agreement, each of Buyer and each of its Subsidiaries have, in all material respects, conducted its business and operated its properties in the ordinary course of business consistent with past practice.

5.19 Financial Ability; Issuance of Buyer Ordinary Shares .

(a) Buyer and Merger Subs have, and will have at the Closing, such cash on hand or

undrawn amounts immediately available under existing credit facilities necessary to consummate the transactions contemplated by this Agreement, including (a) paying any such cash portion of the Closing Merger Consideration at Closing, (b) effecting the repayment of the Closing Indebtedness Payoff Amount, (c) making the other payments required to be made at the Effective Time by Section 3.2(e) and (d) paying all related fees and expenses. Neither Buyer nor either Merger Sub has incurred any obligation, commitment, restriction or liability of any kind, and is not contemplating or aware of any obligation, commitment, restriction or liability of any kind, in either case which would reasonably be expected to impair or adversely affect such resources.

(b) The issuance and delivery of Buyer Ordinary Shares in accordance with this Agreement has been duly authorized by all necessary corporate action on the part of Buyer and, when issued as contemplated hereby, such Buyer Ordinary Shares shall be duly and validly issued, fully paid and nonassessable. Buyer has validly reserved a sufficient number of authorized but unissued Buyer Ordinary Shares to pay the Closing Merger Consideration payable by Buyer under this Agreement. The Buyer Ordinary Shares, when so issued and delivered in accordance with the provisions of this Agreement, shall be free and clear of all Liens, other than those contemplated by this Agreement and any restrictions on transfer created by applicable securities Laws and will not have been issued in violation of applicable Laws or stock market rules or regulations, or any preemptive rights or rights of first refusal or similar rights.

5.20 SEC Filings, Sarbanes-Oxley and Exchange Rules .

(a) SEC Filings . Buyer has timely filed with or furnished to, as applicable, the SEC all Buyer SEC Documents. True, correct, and (subject to any requests by Buyer for confidential treatment) complete copies of all Buyer SEC Documents are publicly available in the Electronic Data Gathering, Analysis, and Retrieval database of the SEC (“ EDGAR ”). As of their respective filing dates or, if amended or superseded by a subsequent filing prior to the date hereof, as of the date of the last such amendment or superseding filing (and, in the case of registration statements and proxy statements, on the dates of effectiveness and the dates of the relevant meetings, respectively), each of the Buyer SEC Documents complied as to form in all material respects with the applicable requirements of the Securities Act, the Exchange Act, and the Sarbanes-Oxley Act of 2002 (including the rules and regulations promulgated thereunder, the “ Sarbanes-Oxley Act ”), and the rules and regulations of the SEC thereunder applicable to such Buyer SEC Documents. None of the Buyer SEC Documents, including any financial statements, schedules, or exhibits included or incorporated by reference therein at the time they were filed (or, if amended or superseded by a subsequent filing prior to the date hereof, as of the date of the last such amendment or superseding filing), contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. To the knowledge of Buyer, none of the Buyer SEC Documents is the subject of ongoing SEC review or outstanding SEC investigation and there are no outstanding or unresolved comments received from the SEC with respect to any of the Buyer SEC Documents. None of Buyer’s Subsidiaries is required to file or furnish any forms, reports, or other documents with the SEC.

(b) Sarbanes-Oxley And Stock Exchange Rules. Each of the principal executive officer and the principal financial officer of Buyer (or each former principal executive officer and each former principal financial officer of Buyer, as applicable) has made all certifications required by Rule 13a-14 or 15d-14 under the Exchange Act and Sections 302 and 906 of the Sarbanes-Oxley Act with respect to the Buyer SEC Documents, and the statements contained in such certifications are true and accurate in all material respects. For purposes of this Agreement, “principal executive officer” and “principal financial officer” shall have the meanings given to such terms in the Sarbanes-Oxley Act. Buyer is in compliance with all of the other applicable provisions of the Sarbanes-Oxley Act and any applicable stock exchange listing and corporate governance rules of, except for any non-compliance that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Buyer.

5.21 No Outside Reliance . Notwithstanding anything contained in this Article V or any other provision hereof, each of Buyer and each Merger Sub acknowledges and agrees that neither the Company nor any of its Affiliates, nor any of its or their respective directors, officers, employees, stockholders, partners, members, agents or representatives, has made, or is making, any representation or warranty whatsoever, express or implied (and neither Buyer nor either Merger Sub has relied on any representation, warranty or statement of any kind by the Company or any of its Affiliates or any of their respective directors, officers, employees, stockholders, partners, members, agents or representatives), beyond those expressly given in Article IV , including any implied warranty or representation as to condition, merchantability, suitability or fitness for a particular purpose or trade as to any of the assets of the Company. Without limiting the generality of the foregoing, it is understood that any cost estimates, financial or other projections or other predictions that may be contained or referred to in the Disclosure Schedules or elsewhere, as well as any information, documents or other materials (including any such materials contained in any “data room” or reviewed by Buyer or any of its Affiliates, agents or representatives pursuant to the Confidentiality Agreement) or management presentations that have been or shall hereafter be provided to Buyer or any of its Affiliates, agents or representatives are not and will not be deemed to be representations or warranties of the Company, and no representation or warranty is made as to the accuracy or completeness of any of the foregoing, except as may be expressly set forth in Article IV .

5.22 No Additional Representations or Warranties . Except as provided in this Article V , none of Buyer, either Merger Sub or any of their respective Affiliates, or any of their respective directors, officers, employees, stockholders, partners, members or representatives has made, or is making, any representation or warranty whatsoever to the Company or its Affiliates, respective directors, officers, employees, stockholders, partners, members or representatives, and no such party shall be liable in respect of the accuracy or completeness of any information provided the Company or its Affiliates, directors, officers, employees, stockholders, partners, members or representatives.

ARTICLE VI.
COVENANTS OF THE COMPANY

6.1 Conduct of Business .

(a) From the date of this Agreement through the Closing, the Company shall, except as would constitute a violation of applicable Law, as set forth on Schedule 6.1 , as contemplated by this Agreement or as consented to by Buyer in writing (which consent shall not be unreasonably conditioned, withheld, delayed or denied), use commercially reasonable efforts to operate its business in the ordinary course in accordance with past practice, and will use reasonable efforts to prepare the material required to file an NDA for IV fosfomycin with the FDA. Without limiting the generality of the foregoing, except as would constitute a violation of applicable Law, as set forth on Schedule 6.1 or as consented to by Buyer in writing (which consent shall not be unreasonably conditioned, withheld, delayed or denied), the Company shall not, except as otherwise contemplated by this Agreement:

(i) (1) change or amend the Company Charter, Company Bylaws or other organizational documents of the Company, except as otherwise required by Law; or (2) authorize for issuance, issue, grant, sell, deliver, dispose of, pledge or otherwise encumber any equity securities of the Company, except for issuances contemplated on Schedule 6.1 or of shares of Company Common Stock upon the exercise of outstanding Company Options or upon the conversion of Company Series A Preferred Stock into Company Common Stock or upon the exercise of the Company Warrants;

(ii) split, combine or reclassify any shares of its capital stock; or declare, set aside or pay any dividend or other distribution (whether in cash, stock or property or any combination thereof) in respect of its capital stock;

(iii) make or declare any dividend or distribution to the stockholders of the Company;

(iv) adopt a plan of complete or partial liquidation or dissolution, recapitalization or other reorganization;

(v) split, combine or reclassify the outstanding shares of Company Capital Stock nor enter into any agreement with respect to voting of any shares of Company Capital Stock;

(vi) hire any new officers or, except in the ordinary course of business, any new employees or consultants;

(vii) create, incur or assume any Indebtedness; assume, guarantee, endorse or otherwise become liable or responsible (whether directly, contingently or otherwise) for the obligations of any other Person; or make any loans, advances or capital contributions to, or investments in, any other Person, in each case, except for Indebtedness, loans, advances, capital contributions to or investments which, individually, are not in excess of $10,000 and, in the aggregate, are not in excess of $25,000;

(viii) (A) modify in any material respect or terminate (excluding any expiration in accordance with its terms) any Contract of a type required to be listed on Schedule 4.12 or any material insurance policy required to be listed on Schedule 4.17 ; (B) enter into any Contract of a type that would be required to be listed on Schedule 4.12 if such Contract

was in effect on the date hereof or (C) take or omit to take any action that would constitute a material violation of or material default under, or waive any material rights under, any Contract of a type required to be listed on Schedule 4.12 ;

(ix) change the nature or scope of its business being carried on as of the date of this Agreement or commence any new business not being ancillary or incidental to such business or take any action to alter its organizational or management structure;

(x) materially change its accounting methods, principles or practices, except insofar as may be required by a generally applicable change in GAAP;

(xi) institute or settle any legal proceeding;

(xii) sell, assign, transfer, convey, lease, license, sublicense or otherwise dispose of any Company Intellectual Property, or any material assets or properties of Company;

(xiii) except as required by Law, existing Company Benefit Plans or existing Contracts, (A) grant any material severance or material termination pay which will become due and payable after the Closing Date; (B) terminate (other than for cause) the employment of any employee; (C) adopt, enter into or materially amend any Company Benefit Plan; or (D) enter into any collective bargaining agreement;

(xiv) acquire by merger or consolidation with, or merge or consolidate with, or purchase all or substantially all of the assets of, any corporation, partnership, association, joint venture or other business organization or division thereof;

(xv) make any material loans or material advances of money to any Person (other than the Company), except for advances to employees or officers of the Company for expenses incurred in the ordinary course of business;

(xvi) (A) make or change any material Tax election, change an annual accounting period, file any material amended Tax Return, enter into any material closing agreement, settle or compromise any claim, notice, audit report or assessment in respect of material Taxes or consent to any extension or waiver of the statute of limitations period applicable to any material Tax claim or assessment, or take any other similar action relating to the filing of any Tax Return or the payment of any Tax, but only to extent such action would adversely affect Buyer or the Company with respect to a Tax period (or portion thereof) beginning after the Closing Date or (B) except as required or permitted by GAAP, make any material change to any accounting principles, methods or practices;

(xvii) other than in the ordinary course of business, abandon, or fail to prosecute or maintain, any Company Owned Intellectual Property, or any Company Licensed Intellectual Property that the Company has the right to prosecute or maintain; or

(xviii) enter into any agreement, or otherwise become obligated, to do any action prohibited under this Section 6.1(a) .

(b) Nothing contained in this Agreement shall give Buyer, directly or indirectly, any right to control or direct the operations of the Company prior to the Closing. Prior to the Closing, each of the Company and Buyer shall exercise, consistent with the other terms and conditions of this Agreement, complete control and supervision over their respective businesses.

(c) From the date of this Agreement through the Closing, the Company shall not, without the prior written consent of Buyer, discharge or cause to be discharged any of the Company’s Indebtedness, except for the payment of interest and principal as such amounts become due under the terms of such Indebtedness in the ordinary course of business (and without regard to the transactions contemplated by this Agreement), and shall not amend or terminate or cause to be amended or terminated any Contracts in respect to such Indebtedness.

6.2 Inspection . Subject to confidentiality obligations and similar restrictions that may be applicable to information furnished to the Company by third parties that may be in the Company’s possession from time to time, and except for any information that is subject to attorney-client privilege or other privilege from disclosure, prior to the Closing, the Company shall afford to Buyer and its accountants, counsel and other representatives reasonable access, during normal business hours, in such manner as to not interfere with the normal operation of the Company to its properties, books, Contracts, commitments, Tax Returns, records and appropriate officers and employees of the Company, and shall furnish such representatives with financial and operating data and other information concerning the affairs of the Company, in each case, as such representatives may reasonably request for the sole purpose of preparing for the operation of the business of the Company following the Closing or in connection with pursuing a firm commitment underwritten public offering of Buyer Ordinary Shares (the “ Public Offering ”); provided , that such investigation shall be conducted in accordance with all applicable Laws, shall only be upon reasonable notice and shall be at Buyer’s sole cost and expense. All information obtained by Buyer, Merger Subs and their respective representatives shall be subject to the Confidentiality Agreement. The Company shall provide (and shall cause its agents and advisors to provide) such reasonable cooperation to Buyer in connection with the Public Offering as Buyer may reasonably request, including providing all information concerning the Company or its business that Buyer (or any underwriters in the Public Offering) reasonably determines is necessary to review in due diligence in connection with the Public Offering or to include in one or more prospectuses or other offering documents in connection therewith (and consenting to the public disclosure thereof and to the filing thereof with the SEC or any other applicable Governmental Authority, subject to the Company’s reasonable request that Buyer seek any available confidential treatment thereof).

6.3 Information Statement . Reasonably promptly following the execution and delivery of this Agreement and the Merger Consent (and in any event within three (3) Business Days), the Company shall, in accordance with applicable Law, including Sections 228 and 262 of the DGCL and the Company Charter and the Company Bylaws, promptly send an information statement (the “ Information Statement ”) to each Company Stockholder that has not theretofore executed a written consent in respect of this Agreement and the transactions contemplated hereby, notifying such Company Stockholder that (i) action has been taken by less than unanimous written consent of the Company Stockholders, (ii) this Agreement was duly adopted and (iii) appraisal rights are available pursuant to Section 262 of the DGCL and the applicable

Law of any other applicable jurisdiction. Such notice shall be in form and substance reasonably acceptable to Buyer and shall at all relevant times be in compliance with Section 262 of the DGCL and other applicable Law. The Company, acting through its Board of Directors, shall include in the Information Statement the unanimous recommendation of its Board of Directors that the stockholders of the Company vote in favor of the adoption of this Agreement and the approval of the First Merger. The Company shall ensure that the Information Statement does not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading (provided that the Company shall not be responsible for the accuracy or completeness of any information concerning the Buyer or Merger Subs furnished by the Buyer in writing for inclusion in the Information Statement).

6.4 Termination of 401(k) Plan . Upon the Buyer’s written request, prior to Closing, the Company shall terminate any and all Company Benefit Plans intended to qualify under Section 401(k) of the Code, or any successor statute, effective not later than the day immediately preceding the Closing Date. Upon the termination of such plans, the Company shall provide the Buyer with evidence that such 401(k) plans have been terminated pursuant to resolution of the Company’s board of directors not later than the day immediately preceding the Closing Date.

6.5 Section 280G Vote . Prior to the Closing Date, the Company shall submit to a stockholder vote, in a manner that satisfies the stockholder approval requirements under Section 280G(b)(5)(B) of the Code and the Treasury Regulations promulgated thereunder, the right of any “disqualified individual” (as defined in Section 280G(c) of the Code) to receive any and all payments (or other benefits) contingent on the consummation of the transactions contemplated by this Agreement (within the meaning of Section 280G(b)(2)(A)(i) of the Code) to the extent necessary so that no payment received by such “disqualified individual” shall be a “parachute payment” under Section 280G(b) of the Code (determined without regard to Section 280G(b)(4) of the Code). Such vote shall establish each disqualified individual’s right to the payment or other compensation, and the Company shall obtain any required waivers or consents from the disqualified individual prior to the vote. In addition, the Company shall provide adequate disclosure to Company stockholders that hold voting Company Capital Stock of all material facts concerning all payments to any such disqualified individual that, but for such vote, could be deemed “parachute payments” under Section 280G of the Code in a manner that satisfies Section 280G(b)(5)(B)(ii) of the Code and Treasury Regulations promulgated thereunder. Prior to the vote, Buyer and its counsel shall be given a reasonable right to review and comment on all documents required to be delivered to the Company stockholders in connection with such vote and any required disqualified individual waivers or consents, and the Company shall reflect all reasonable comments of Buyer thereon. Buyer and its counsel shall be provided copies of the approval documents executed by the stockholders and the waivers executed by the disqualified individuals in connection with the vote.

ARTICLE VII.
COVENANTS OF BUYER

7.1 Director & Officer Indemnification and Insurance .

(a) For a period of six (6) years from the Effective Time, Buyer agrees that it shall indemnify and hold harmless each present and former director, officer and employee of

the Company against any costs or expenses (including reasonable attorneys’ fees), judgments, fines, losses, claims, damages or liabilities incurred in connection with any Action, whether civil, criminal, administrative or investigative, arising out of or pertaining to matters existing or occurring at or prior to the Effective Time, whether asserted or claimed prior to, at or after the Effective Time, to the fullest extent permitted in the Company’s certificate of incorporation, bylaws or other organizational documents in effect on the date of this Agreement (including promptly advancing expenses as incurred to the fullest extent permitted thereunder). Without limiting the foregoing, Buyer shall cause the Company for a period of not less than six (6) years from the Effective Time (i) to maintain provisions in its certificate of incorporation, bylaws or other organizational documents concerning the indemnification and exoneration (including provisions relating to expense advancement) of the Company’s former and current officers, directors and employees that are no less favorable to those Persons than the provisions of the certificate of incorporation, bylaws or other organizational documents of the Company, in each case, as of the date of this Agreement, and (ii) not to amend, repeal or otherwise modify such provisions in any respect that would adversely affect the rights of those Persons thereunder, in each case, except as required by Law.

(b) The Company shall obtain at or prior to the Closing a prepaid, non-cancelable six-year “tail” policy containing terms not less favorable than the terms of the Company’s current directors’ and officers’ liability insurance coverage with respect to matters existing or occurring at or prior to the Effective Time (the cost of which, to the extent not paid prior to the Closing, shall be a Transaction Expense).

(c) The rights of indemnification and to receive advancement of expenses as provided by this Agreement shall not be deemed exclusive of any other rights to which any Person entitled to indemnification under this Section 7.1 (an “ Indemnified Person ”) may at any time be entitled. No right or remedy herein conferred by this Agreement is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at Law or in equity or otherwise. The assertion of any right or remedy hereunder, or otherwise, shall not prevent the concurrent or subsequent assertion of any other right or remedy.

(d) Notwithstanding anything contained in this Agreement to the contrary, this Section 7.1 shall survive the consummation of the First Merger indefinitely and shall be binding, jointly and severally, on all successors and assigns of Buyer and the Final Surviving Corporation. In the event that Buyer or the Final Surviving Corporation or any of their respective successors or assigns consolidates with or merges into any other Person and shall not be the continuing or surviving corporation or entity of such consolidation or merger, or transfers or conveys all or substantially all of its properties and assets to any Person, then, and in each such case, proper provision shall be made so that the successors and assigns of Buyer or the Final Surviving Corporation, as the case may be, shall succeed to the obligations set forth in this Section 7.1.

(e) Buyer shall assume, and be jointly and severally liable for, and shall cause the Final Surviving Corporation to honor, each of the covenants in this Section 7.1 .

7.2 Employment Matters .

(a) From and after the Closing, Buyer shall, or shall cause the Final Surviving Corporation to, assume, honor and perform in accordance with their terms all Company Benefit Plans, including, without limitation, all employment, severance, bonus (including the Company’s 2018 Corporate Bonus Plan pursuant to the terms of Section 7.2(d) below), transaction, incentive and other compensation arrangements with any employee or independent contractor of the Company or its Subsidiaries, and references therein to the Company shall thereafter be deemed references to the Final Surviving Corporation. Buyer hereby acknowledges and agrees that the transactions contemplated by this Agreement shall constitute a “Change in Control” or “Change of Control” for purposes of the Company Benefit Plans, including, without limitation, all employment, severance, bonus, transaction, incentive and other compensation arrangements with any employee or independent contractor of the Company or its Subsidiaries.

(b) From and after the Closing until the first anniversary of the Closing Date, Buyer and its Affiliates shall provide, or shall cause the Final Surviving Corporation to provide, to each employee of the Company immediately prior to the Closing who continues in employment with Buyer and its Affiliates (including the Final Surviving Corporation) immediately following the Closing (such employees, the “ Continuing Employees ”), for so long as the Continuing Employee remains employed by Buyer or any of its Affiliates (including the Final Surviving Corporation) during such period, (i) a base salary or regular hourly wage, as applicable, that is not less than the base salary or regular hourly wage, as applicable, provided to such Continuing Employee immediately prior to the Closing Date, (ii) bonus or incentive opportunities that are no less favorable than the bonus or incentive opportunities provided to such Continuing Employee immediately prior to the Closing Date (provided, however, that in light of the bonus amount due to Continuing Employees upon a Corporate Transaction under the Company’s 2018 Corporate Bonus Plan, there shall be no requirement that Buyer or its Affiliates cause the Final Surviving Corporation to provide any Continuing Employee with any further bonus or incentive opportunity for the 2018 fiscal year) and (iii) employee and fringe benefits (including, health, welfare, retirement and severance benefits) that are at least as favorable, in the aggregate, as those provided to such Continuing Employee immediately prior to the Closing.

(c) Effective as of the Closing and while each Continuing Employee remains employed by Final Surviving Corporation, Buyer or an Affiliate of Buyer, Buyer and its Affiliates shall recognize, or shall cause the Final Surviving Corporation to recognize, to the same extent recognized by the Company prior to the Closing, each Continuing Employee’s employment or service with the Company (including any current or former Affiliate of the Company or any predecessor of the Company) prior to the Closing for all purposes, including for purposes of determining, as applicable, eligibility for participation, vesting and entitlement of the Continuing Employee under all employee benefit plans maintained by the Final Surviving Corporation, Buyer or an Affiliate of Buyer, including vacation plans or arrangements, retirement plans and any severance or welfare plans (but not for purposes of benefit accrual under any employee benefits plan of Buyer or its Affiliates that is a defined benefit pension plan), except to the extent such

recognition would result in a duplication of benefits. In addition, and without limiting the generality of the foregoing, effective as of the Closing and thereafter while each Continuing Employee remains employed by Final Surviving Corporation, Buyer or an Affiliate of Buyer, Buyer and its Affiliates shall, or shall cause the Final Surviving Corporation to use commercially reasonable efforts to, (i) cause any pre-existing conditions or limitations, eligibility waiting periods, actively at work requirements, evidence of insurability requirements or required physical examinations under any health or similar plan of the Final Surviving Corporation, Buyer or an Affiliate of Buyer to be waived with respect to Continuing Employees and their eligible dependents, except to the extent that any waiting period, exclusions or requirements still applied to such Continuing Employee under the comparable Company Benefit Plan in which such Continuing Employee participated immediately before the Closing, and (ii) fully credit each Continuing Employee with all deductible payments, co-payments and other out-of-pocket expenses incurred by such Continuing Employee and his or her covered dependents under the medical, dental, pharmaceutical or vision benefit plans of the Company prior to the Closing during the plan year in which the Closing occurs for the purpose of determining the extent to which such Continuing Employee has satisfied the deductible, co-payments, or maximum out-of-pocket requirements applicable to such Continuing Employee and his or her covered dependents for such plan year under any medical, dental, pharmaceutical or vision benefit plan of the Final Surviving Corporation, Buyer or an Affiliate of Buyer, as if such amounts had been paid in accordance with such plan.

(d) To the extent such amounts are not paid by Company prior to the Closing, immediately following the Closing, Buyer shall, or shall cause the Final Surviving Corporation to, pay the bonus amounts set forth on Schedule 7.2(d) pursuant to the “Corporate Transaction Provisions” of the Company’s 2018 Corporate Bonus Plan (triggered by the Merger) to each of the Company’s employees who were employed by the Company as of immediately prior to the Closing, which payments shall be paid in cash in accordance with the terms of the Company’s 2018 Corporate Bonus Plan (the “ 2018 Company Bonus Payments ”).

(e) The Company and Buyer acknowledge and agree that all provisions contained in this Section 7.2 are included for the sole benefit of Buyer and the Company, and that nothing in this Agreement, whether express or implied (i) shall be treated as an amendment or other modification of any Company Benefit Plan or other employee benefit plan, agreement or other arrangement, (ii) shall limit the right of Buyer, the Company or their respective Affiliates to amend, terminate or otherwise modify any Company Benefit Plan or other employee benefit plan, agreement or other arrangement following the Closing Date, or (iii) shall confer upon any other Person who is not a party to this Agreement (including any equity holder, any current or former director, officer, employee or independent contractor of the Company, or any participant in any Company Benefit Plan or other employee benefit plan, agreement or other arrangement (or any dependent or beneficiary thereof)), any right to continued or resumed employment or recall, any right to compensation or benefits, or any third-party beneficiary or other right of any kind or nature whatsoever.

7.3 Retention of Books and Records . Buyer shall cause the Final Surviving Corporation to retain all books, ledgers, files, reports, plans, operating records and any other material documents pertaining to the Company in existence at the Closing that are required to be retained under current retention policies for at least a period of seven (7) years from the Closing Date or, if longer, until the last Milestone Payment has been made, and to make the same available after the Closing for inspection and copying by the Stockholder Representative or its representatives at the Stockholder Representative’s expense, during regular business hours and upon reasonable request and upon reasonable advance notice.

7.4 Contact with Customers and Suppliers . Until the Closing Date, Buyer shall not, and shall cause its representatives not to, contact or communicate with the employees, collaborators, suppliers, distributors or licensors of the Company or any other Persons having a business relationship with the Company, concerning the transactions contemplated hereby without the prior written consent of the Company.

7.5 Registration Rights .

(a) Registration Procedures and Expenses . Buyer will file with the SEC, within thirty (30) days following the delivery of any Buyer Ordinary Shares in respect of any Milestone Payment, a registration statement on Form S-1, Form S-3 or other applicable form available to Buyer (the “ Registration Statement ”) covering the resale to the public of all Buyer Ordinary Shares issued or to be issued to the Pre-Closing Holders pursuant to any Milestone Payment paid in Buyer Ordinary Shares under this Agreement (the “ Registrable Securities ”). Buyer shall use its commercially reasonable efforts to cause the Registration Statement to be declared effective by the SEC as soon as practicable. Within thirty (30) days of any subsequent issuance by Buyer of Buyer Ordinary Shares to the Pre-Closing Holders pursuant to the terms of this Agreement, Buyer will amend such Registration Statement (or, if applicable, file a new Registration Statement) covering the resale to the public of all such additional Buyer Ordinary Shares issued pursuant to this Agreement. Notwithstanding the foregoing sentences of this Section 7.5(a) , Buyer may postpone the filing or the effectiveness of a Registration Statement or of a supplement or amendment thereto or suspend the use of an effective Registration Statement if and to the extent the Board of Directors of Buyer determines in good faith that such Registration Statement would (i) reasonably be expected to materially impede, delay, interfere with or otherwise have a material adverse effect on any material acquisition of assets (other than in the ordinary course of business), merger, consolidation, tender offer, financing or any other material business transaction by Buyer or (ii) require disclosure of information that has not been, and is otherwise not required to be, disclosed to the public, the premature disclosure of which Buyer, after consultation with outside counsel to Buyer, believes would materially and adversely affect Buyer; provided , however , that Buyer may not invoke this right more than twice, or for an aggregate period of more than 120 days, in any twelve (12) month period.

(b) Indemnification . Buyer agrees to indemnify and hold harmless each Pre-Closing Holder whose Buyer Ordinary Shares issued hereunder are included in the Registration Statement against any losses, claims, damages, expenses or liabilities to which such Pre-Closing Holder may become subject by reason of any untrue statement of a material fact

contained in the Registration Statement or any omission to state therein a fact required to be stated therein or necessary to make the statements therein not misleading, except insofar as such losses, claims, damages, expenses or liabilities arise out of or are based upon information furnished to Buyer by or on behalf of a Pre-Closing Holder for use in the Registration Statement. Buyer shall have the right to assume the defense and settlement of any claim or suit for which Buyer may be responsible for indemnification under this Section.

7.6 Conduct of Business of Buyer . From the date of this Agreement through the Closing, Buyer shall, except as would constitute a violation of applicable Law, as contemplated by this Agreement or as consented to by the Company in writing (which consent shall not be unreasonably conditioned, withheld, delayed or denied), use commercially reasonable efforts to operate its business in the ordinary course in accordance with past practice.

7.7 Stock Exchange Listing . Buyer shall use its reasonable best efforts to cause the Buyer Ordinary Shares to be issued pursuant to this Agreement to be approved for listing on the Nasdaq Stock Market, subject to official notice of issuance, no later than the date of effectiveness of the Registration Statement.

7.8 Shareholder Approval . Buyer shall use commercially reasonable efforts to obtain Shareholder Approval. In furtherance (and without limitation) of the foregoing, the Buyer will hold a meeting of shareholders no later than December 31, 2018 at which a proposal for obtaining Shareholder Approval shall be considered, with, subject to compliance with its fiduciary duties, the recommendation of Buyer’s Board of Directors that such proposal be approved, and Buyer shall solicit proxies from its shareholders in connection therewith in the same manner as any other management proposals in such proxy statement and all management-appointed proxyholders shall vote their proxies in accordance with the recommendation of Buyer’s Board of Directors.

ARTICLE VIII.
JOINT COVENANTS

8.1 Support of Transaction . Without limiting any covenant contained in Article VI or Article VII , Buyer and the Company shall each, and Buyer shall cause its Subsidiaries to use commercially reasonable efforts to: (a) assemble, prepare and file any information (and, as needed, to supplement such information) as may be reasonably necessary to obtain as promptly as practicable all governmental and regulatory consents required to be obtained in connection with the transactions contemplated hereby, (b) obtain all material consents and approvals of third parties that any of Buyer, the Company or their respective Affiliates are required to obtain in order to consummate the First Merger, and (c) take such other action as may reasonably be necessary or as another party may reasonably request to satisfy the conditions of Article IX or otherwise to comply with this Agreement and to consummate the transactions contemplated hereby as soon as practicable (but in any event prior to the Outside Date).

8.2 Stockholder Approval . Within two (2) Business Days after the execution and delivery of this Agreement, the Company shall, in accordance with the DGCL, the Company Charter and the Company Bylaws, obtain and deliver to Buyer a true, correct and complete copy of an irrevocable written consent of holders of (a) at least a majority of the issued and outstanding shares of Company Capital Stock and (b) at least a majority of the issued and outstanding shares

of Company Series A Preferred Stock, to adopt this Agreement and approve the First Merger and the other transactions contemplated hereby (the “ Merger Consent ”). Immediately following the execution and delivery of this Agreement, Buyer, as sole stockholder of Merger Subs, shall adopt this Agreement and approve each Merger and the related transactions contemplated hereby in accordance with the DGCL and each Merger Sub’s certificate of incorporation and bylaws.

8.3 Further Assurances. Each party hereto agrees that, from time to time after the Closing Date, it will execute and deliver, or cause its Affiliates to execute and deliver, such further instruments, and take (or cause its Affiliates to take) such other action, as may be reasonably necessary to carry out the purposes and intents of this Agreement.

8.4 Tax Matters .

(a) With respect to Tax Returns required to be filed by, on behalf of or with respect to, the Company, the Company shall prepare or cause to be prepared, in a manner consistent with past practice, and timely file or cause to be timely filed when due (taking into account all extensions properly obtained) all such Tax Returns that are required to be filed on or prior to the Closing Date, and the Company shall pay or cause to be paid any Taxes due in respect of such Tax Returns. Buyer shall prepare or cause to be prepared, in a manner consistent with past practice (unless otherwise required by Law), and file or cause to be filed when due (taking into account all extensions properly obtained) all Tax Returns that relate to any Tax period ending on or before the Closing Date but that are required to be filed after the Closing Date and all Tax Returns that are required to be filed by or with respect to the Company for a Straddle Period; provided , that Buyer shall in the case of any such Tax Returns (i) provide any such Tax Returns to the Stockholder Representative for review and approval, which approval shall not be unreasonably withheld, no less than thirty (30) days prior to the due date (taking into account all extensions properly obtained) for timely filing of any such income Tax Returns, or if such Tax Return is not an income Tax Return, as promptly as practical prior to the due date (taking into account all extensions properly obtained) for timely filing of such Tax Return, and (ii) consider in good faith revisions to such income and other material Tax Returns as are reasonably requested by the Stockholder Representative.

(b) In the case of any Straddle Period, the portion of any Tax that is allocable to the taxable period that is deemed to end on the Closing Date will be: (i) in the case of Property Taxes, deemed to be the amount of such Taxes for the entire Straddle Period multiplied by a fraction, the numerator of which is the number of calendar days of such Straddle Period in the Pre-Closing Tax Period and the denominator of which is the number of calendar days in the entire Straddle Period, and (ii) in the case of all other Taxes, determined as though the taxable year of the Company terminated at the close of business on the Closing Date.

(c) Buyer shall not, and shall not permit or cause the Company or any of Buyer’s Affiliates to, (i) file or amend (or cause to be filed or amended) any Tax Return of the Company for any Pre-Closing Tax Period (including any Tax Returns required to be filed by Buyer as described in Section 8.4(a) ), (ii) extend or waive the applicable statute of limitations for the assessment of any Tax or deficiency relating to any Pre-Closing Tax

Period, (iii) make (or cause to be made) or change (or cause to be changed) any Tax election or accounting method that has retroactive effect to any Pre-Closing Tax Period or (iv) engage in any voluntary disclosures or discussions with any Tax Authority in respect of the Company for any Pre-Closing Tax Period that would reasonably be expected to result in any Tax liability for which any Buyer Indemnified Party may be indemnified pursuant to this Agreement, in each case without the prior written consent of the Stockholder Representative, which consent shall not be unreasonably withheld. For purposes of this Agreement, any Taxes attributable to any transaction that Buyer causes the Company to engage in after the Closing on the Closing Date that is both outside the ordinary course of business and not contemplated by this Agreement shall be allocated to the Tax period beginning after the Closing Date.

(d) The Pre-Closing Holders shall be entitled to any refund of Taxes (including any interest paid thereon by the applicable Governmental Authority) for any Pre-Closing Tax Period to the extent such Taxes were paid by the Company prior to the Closing which refund is actually received by Buyer or its Affiliates after the Closing, in each case except for any refund (i) that results from the carry back of any Tax credit or attribute from any Tax period beginning after the Closing Date or (ii) that was included in Closing Date Net Working Capital. Buyer shall pay, or cause to be paid, to the Stockholder Representative for payment to the Pre-Closing Holders in accordance with the Payment Spreadsheet any amount to which the Pre-Closing Holders are entitled pursuant to the prior sentence within ten (10) Business Days of the receipt of the applicable refund by Buyer or its Affiliates net of any reasonable costs to Buyer or its Affiliates attributable to obtaining and the receipt of such refund. To the extent requested by the Stockholder Representative, Buyer will reasonably cooperate with the Stockholder Representative (at the Pre-Closing Holders’ expense) in obtaining such refund, including through the filing of amended Tax Returns for periods ending before or on the Closing Date or refund claims. To the extent such refund is subsequently disallowed or required to be returned to the applicable Governmental Authority, the Pre-Closing Holders shall repay the amount of such refund, together with any interest, penalties or other additional amounts imposed by such Governmental Authority, to Buyer within ten (10) Business Days of such refund being disallowed or required to be returned to the applicable Governmental Authority.

(e) Each of the parties hereto shall, and shall cause its Affiliates to, provide to the other parties such cooperation, documentation and information relating to the Company or its assets as such parties may reasonably request and that is reasonably necessary in (A) filing any Tax Return, amended Tax Return or claim for refund, (B) determining a liability for Taxes or a right to refund of Taxes, (C) making any Tax election, or (D) prosecuting or defending any audit, examination, contest, litigation, or other proceeding relating to any Tax. In this regard, the parties hereto shall retain (or cause to be retained) all books and records with respect to Tax matters of the Company which are or may be pertinent to any Tax period beginning before the Closing Date until the expiration of the applicable statute of limitations. Notwithstanding anything to the contrary in this Agreement, the Stockholder Representative shall have no right to review or obtain information with respect to any combined or consolidated Tax Return of Buyer except to the extent the relevant information relates solely to the Company.

(f) If, subsequent to the Closing, Buyer or the Final Surviving Corporation receives notice of any audit, other administrative proceeding or inquiry or judicial proceeding involving Taxes of the Company for a Pre-Closing Tax Period which could reasonably be expected to result in any Tax liability for which any Buyer Indemnified Party may be indemnified pursuant to this Agreement (a “ Tax Contest ”), then within fifteen (15) days after receipt of such notice, Buyer shall notify the Stockholder Representative of such notice, provided , however , that failure to notify the Stockholder Representative will not relieve the Pre-Closing Holders of any liability they may have to the Buyer Indemnified Parties, except to the extent the defense of such Tax Contest is prejudiced by Buyer’s failure to give such notice. Buyer shall have the right to control the conduct and resolution of any Tax Contest; provided , however , that the Buyer shall keep the Stockholder Representative (who may participate in such Tax Contest at its own expense) reasonably informed of the progress of such Tax Contest and shall not effect any settlement or compromise of such Tax Contest without obtaining the Stockholder Representative’s prior written consent thereto, which consent shall not be unreasonably withheld, conditioned or delayed. In the event of any conflict between the provisions of this Section 8.4 and Section 11.3 with respect to Tax Contests, the provisions of this Section 8.4 shall control.

(g) Transfer Taxes shall be borne one-half by Buyer and one-half by the Pre-Closing Holders. Buyer will timely file all Tax Returns and other documentation necessary with respect to all Transfer Taxes and, to the extent required by applicable Law, the parties hereto will cooperate in the execution of such Tax Returns and other documentation.

(h) For United States federal income tax purposes, the Merger is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Code and to not be subject to Section 367(a)(1) of the Code (the “ Intended Tax Treatment ”). The parties adopt this Agreement as a “plan of reorganization” for purposes of Sections 354 and 361 of the Code and within the meaning of Section 1.368-2(g) of the Treasury Regulations. Each of the parties shall use its reasonable best efforts to cause the Merger to qualify for the Intended Tax Treatment. None of the parties shall (and each of the parties shall cause their respective Subsidiaries not to) take any action, or fail to take any action, that could reasonably be expected to cause the Merger to fail to qualify for the Intended Tax Treatment. The parties shall consider in good faith such amendments to this Agreement as may be reasonably required to cause the Merger to qualify for the Intended Tax Treatment (it being understood that no party will be required to agree to any such amendment). The parties shall not file any U.S. federal, state or local Tax Return in a manner that is inconsistent with the Intended Tax Treatment of the Merger unless otherwise required by applicable Law.

8.5 Private Placement. Each of the Company and Buyer shall take all reasonably necessary action on its part such that the issuance of Buyer Ordinary Shares pursuant to this Agreement constitutes a transaction exempt from registration under the Securities Act in compliance with Rule 506 of Regulation D promulgated thereunder. Without limiting the generality of the foregoing, prior to the Closing Date the Company shall (a) provide each Company Stockholder with an investor questionnaire in a form reasonably acceptable to Buyer and (b) provide each Company Stockholder with either the Support Agreement or, to the extent such Company Stockholder is not

a party to the Support Agreement, an Investment Agreement in the form attached hereto as Annex D .

ARTICLE IX.
CONDITIONS TO OBLIGATIONS

9.1 Conditions to the Obligations of Buyer, Merger Subs and the Company . The obligations of Buyer, Merger Subs and the Company to consummate, or cause to be consummated, the First Merger are subject to the satisfaction of the following conditions, any one or more of which may be waived in writing by all of such parties:

(a) No Governmental Authority of competent jurisdiction shall have enacted, issued, promulgated, enforced or entered any statute, rule, regulation, executive order, decree, injunction or other order (whether temporary, preliminary or permanent) which is in effect and which prohibits, restrains, enjoins or makes illegal the consummation of the First Merger, and there shall not be any threatened, instituted or pending action by a Governmental Authority seeking to prohibit, restrain or enjoin the consummation of the First Merger or other transactions under this Agreement.

(b) The Merger Consent shall have been validly obtained.

9.2 Conditions to the Obligations of Buyer and Merger Subs . The obligations of Buyer and Merger Subs to consummate, or cause to be consummated, the First Merger are subject to the satisfaction of the following additional conditions, any one or more of which may be waived in writing by Buyer and Merger Subs:

(a) Each of the Fundamental Representations of the Company shall be true and correct in all material respects as of the date hereof and as of the Closing Date, as if made anew at and as of that date, except with respect to representations and warranties which speak as to an earlier date, which representations and warranties shall be true and correct in all material respects at and as of such date, except for any changes after the date of this Agreement which are contemplated or expressly permitted by this Agreement; and each of the other representations and warranties of the Company contained in Article IV , disregarding all qualifications contained herein relating to materiality or Material Adverse Effect, shall be true and correct as of the date hereof and as of the Closing Date, as if made anew at and as of that date, except with respect to representations and warranties which speak as to an earlier date, which representations and warranties shall be true and correct at and as of such date, except for (i) any inaccuracy or omission that would not reasonably be expected to have a Material Adverse Effect on the Company and (ii) any changes after the date of this Agreement which are contemplated or expressly permitted by this Agreement.

(b) Each of the covenants of the Company to be performed at or prior to the Closing shall have been performed in all material respects.

(c) The Company shall have delivered to Buyer a certificate signed by an officer of the Company, dated as of the Closing Date, certifying that the conditions specified in Section 9.2(a) and Section 9.2(b) have been fulfilled (the “ Closing Certificate ”).

(d) Since the date of this Agreement, there shall have not have occurred a Material Adverse Effect on the Company.

(e) The aggregate number of shares of Company Capital Stock held by Cash-Out Holders shall not exceed fifteen percent (15%) of the number of outstanding shares of Company Capital Stock as of the Effective Time (calculated after giving effect to the conversion into shares of Company Common Stock of all outstanding shares of Company Series A Preferred Stock, Company Options and Company Warrants) and there shall be no more than 35 Pre-Closing Holders that are not Accredited Investors.

(f) The aggregate number of (i) Dissenting Shares shall not exceed five percent (5%) and (ii) Dissenting Shares, together with shares of Company Capital Stock eligible to become Dissenting Shares, shall not exceed fifteen percent (15%), in each case, of the number of outstanding shares of Company Capital Stock as of the Effective Time (calculated after giving effect to the conversion into shares of Company Common Stock of all outstanding shares of Company Series A Preferred Stock, Company Options and Company Warrants).

(g) The Estimated Closing Cash Amount shall be equal to or greater than the sum of (i) the Estimated Closing Indebtedness Amount and (ii) the Estimated Excess Transaction Expenses, in each case as reflected on the estimated Closing Balance Sheet delivered pursuant to Section 3.3.

(h) The Company shall have delivered to Buyer a certificate in accordance with the requirements of Treasury Regulations Sections 1.897-2(h) and 1.1445-2(c)(3).

9.3 Conditions to the Obligations of the Company . The obligations of the Company to consummate, or cause to be consummated, the First Merger are subject to the satisfaction of the following additional conditions, any one or more of which may be waived in writing by the Company:

(a) Each of the Fundamental Representations of Buyer and Merger Subs (other than Section 5.6 ) shall be true and correct in all material respects as of the date hereof and as of the Closing Date, as if made anew at and as of that date, except with respect to representations and warranties which speak as to an earlier date, which representations and warranties shall be true and correct in all material respects at and as of such date, except for any changes after the date of this Agreement which are contemplated or expressly permitted by this Agreement; the representations and warranties of Buyer in Section 5.6 (Capitalization of Buyer) shall be true and correct (other than for de minimis inaccuracies) as of the date of this Agreement and as of the Closing Date, as if made anew at and as of that date (provided that to the extent any representations and warranties in Section 5.6 are made as of a specified date, such representations and warranties shall be true and correct (other than for de minimis inaccuracies) only as of such specified date); and each of the other representations and warranties of Buyer and Merger Subs contained in Article V , disregarding all qualifications contained herein relating to materiality or Material Adverse Effect, shall be true and correct as of the date hereof and as of the Closing Date, as if made anew at and as of that date, except with respect to representations and warranties which speak as to an earlier date, which representations

and warranties shall be true and correct at and as of such date, except for (i) any inaccuracy or omission that would not reasonably be expected to have a Material Adverse Effect on Buyer and (ii) any changes after the date of this Agreement which are contemplated or expressly permitted by this Agreement.

(b) Each of the covenants of Buyer and Merger Subs to be performed at or prior to the Closing shall have been performed in all material respects.

(c) Buyer shall have delivered to the Company a certificate signed by an officer of Buyer, dated as of the Closing Date, certifying that the conditions specified in Section 9.3(a) and Section 9.3(b) have been fulfilled (the “ Buyer Closing Certificate ”).

9.4 Waiver of Conditions; Frustration of Conditions . All conditions to the Closing shall be deemed to have been satisfied or waived following the Effective Time. None of the Company, Buyer or Merger Subs may rely on the failure of any condition set forth in this Article IX to be satisfied if such failure was caused by the failure of the Company, on the one hand, or Buyer or Merger Subs, on the other hand, respectively, to (i) use reasonable best efforts to consummate the First Merger and the other transactions contemplated hereby and (ii) otherwise comply with its obligations under this Agreement.

ARTICLE X.
TERMINATION/EFFECTIVENESS

10.1 Termination . This Agreement may be terminated and the transactions contemplated hereby abandoned at any time prior to the Closing:

(a) by duly authorized mutual written consent of Buyer and the Company;

(b) by written notice to the Company from Buyer if:

(i) there is any material breach of any representation, warranty, covenant or agreement on the part of the Company set forth in this Agreement, such that the conditions specified in Section 9.2(a) or Section 9.2(b) would not be satisfied at the Closing, except that, if such breach is curable by the Company through the exercise of such commercially reasonable efforts, then, for a period of up to thirty (30) days after receipt by the Company of notice from Buyer of such breach, but only as long as the Company continues to use commercially reasonable efforts to cure such breach (the “ Company Cure Period ”), such termination shall not be effective and the Outside Date shall be automatically extended until the end of the Company Cure Period, and such termination shall become effective only if such breach is not cured within the Company Cure Period;

(ii) the Closing has not occurred on or before November 30, 2018 (subject to extension as set forth in this Article X , the “ Outside Date ”), unless Buyer’s or Merger Subs’ breach is the primary reason for the Closing not occurring on or before such date; or

(iii) the consummation of any of the transactions contemplated hereby is permanently enjoined, prohibited or otherwise restrained by the terms of a final, non-appealable order or judgment of a court of competent jurisdiction; or

(iv) if the Merger Consent shall not have been obtained prior to 5:00 p.m., New York time, on the second (2 nd ) Business Day immediately following the date of this Agreement.

(i) (A) there is any material breach of any representation, warranty, covenant or agreement on the part of Buyer or Merger Subs set forth in this Agreement, such that the conditions specified in Section 9.3(a) or Section 9.3(b) would not be satisfied at the Closing, except that, if any such breach is curable by Buyer through the exercise of commercially reasonable efforts, then, for a period of up to thirty (30) days after receipt by Buyer of notice from the Company of such breach, but only as long as Buyer continues to exercise such commercially reasonable efforts to cure such breach (the “ Buyer Cure Period ”), such termination shall not be effective and the Outside Date shall automatically be extended until the end of the Buyer Cure Period, and such termination shall become effective only if such breach is not cured within the Buyer Cure Period, or (B) (1) all of the conditions set forth in Sections 9.1 and 9.2 have been satisfied (other than those conditions that by their nature are to be satisfied at the Closing) as of the date the Closing should have occurred pursuant to Section 2.3 , and (2) Buyer or Merger Subs has failed to consummate the transactions contemplated by this Agreement within three (3) Business Days following the date the Closing should have occurred pursuant to Section 2.3 ;

(ii) the Closing has not occurred on or before the Outside Date, unless the Company’s breach is the primary reason for the Closing not occurring on or before such date; or

10.2 Effect of Termination . Except as otherwise set forth in this Section 10.2 , in the event of the termination of this Agreement pursuant to Section 10.1 , this Agreement shall forthwith become void and have no effect, without any liability on the part of any party hereto or its respective Affiliates, officers, directors, employees or stockholders, other than liability of the Company, Buyer or Merger Subs, as the case may be, for any intentional and willful breach of this Agreement occurring prior to such termination; provided , however , that a failure of Buyer or Merger Subs to consummate the First Merger, or take any other action, in breach of this Agreement shall be deemed to be intentional and willful whether or not Buyer and Merger Subs had sufficient funds available to consummate the First Merger or take such action. The provisions of this Section 10.2 , Article XI and Article XII , and the Confidentiality Agreement shall survive any termination of this Agreement.

ARTICLE XI.
INDEMNIFICATION

11.1 Survival of Representations, Warranties and Covenants . Each representation warranty, covenant and obligation contained herein and any certificate related to any such representation, warranty, covenant or obligation will survive the Closing and continue in full force and effect for twelve (12) months after the Closing Date (the “ Survival Expiration Date ”); provided , however , that any covenant contained in this Agreement that, by its terms, provides for performance following the Closing shall survive for the period provided in such covenant, if any, or until such covenant is performed and that each Fundamental Representation shall survive for a period of six (6) years after the Closing Date. No claim for indemnification for breach of any representation, warranty, covenant or agreement contained in, or otherwise pursuant to, this Agreement (other than any covenant (excluding this Article XI ) that provides for performance following the Closing) may be asserted pursuant to this Agreement unless on or before the Survival Expiration Date, such claim is asserted by written notice in accordance with this Article XI , and if such a notice is given, the Survival Expiration Date with respect to such claim shall continue until the claim is fully and finally resolved.

11.2 Indemnification .

(a) Subject to Section 11.4 , from and after the Closing, the Pre-Closing Holders, severally (and not jointly) in accordance with their respective Pro Rata Shares, shall defend, indemnify and hold harmless Buyer and its Affiliates (including, after the Closing, the Company, the Final Surviving Corporation and the Subsidiaries) and its and their respective officers, directors, employees, shareholders, agents and representatives (collectively, the “ Buyer Indemnified Parties ”) and will compensate and reimburse the Buyer Indemnified Parties for, any and all Losses incurred or suffered by any Buyer Indemnified Party (regardless of whether such Losses relate to any Third-Party Claim) resulting from, relating to or constituting: (i) any breach of any representation or warranty the Company has made in Article IV of this Agreement or in the Closing Certificate; (ii) any breach by the Company of any covenant or agreement of the Company in this Agreement that, by its terms, provides for performance by the Company prior to the Closing (other than Section 6.2 or 8.1 ); (iii) any Closing Indebtedness and any Excess Transaction Expenses, in each case to the extent in excess of the amounts included in the calculation of the Adjustment Amount; (iv) any inaccuracy in the Payment Spreadsheet, as in effect from time to time; (v) any failure of any Company Stockholder to have good, valid and marketable title to the issued and outstanding shares of Company Capital Stock issued in the name of such Company Stockholder, free and clear of all Liens; (vi) any untrue statement of a material fact contained in the Registration Statement or any omission to state therein a fact required to be stated therein or necessary to make the statements therein not misleading to the extent such losses, claims, damages, expenses or liabilities arise out of or are based upon information furnished by the Pre-Closing Holders to Buyer for use in the Registration Statement and (vii) the following Taxes: (A) any Taxes for any taxable period (or portion thereof) ending on or before the Closing Date due and payable by the Company; (B) any Taxes for which the Company has any liability under Treasury Regulation Section 1.1502-6 or under any comparable or similar provision of state, local or foreign Laws as a result of being a member of an affiliated, consolidated, combined, unitary or similar group on or prior to the Closing Date; (C) any Taxes for which the Company has any liability as a transferee or successor, pursuant to any contractual obligation or otherwise, which Tax is

attributable to the operations of the Company on or prior to the Closing Date or an event or transaction occurring before the Closing; and (D) any Transfer Taxes that are the responsibility of the Pre-Closing Holders pursuant to Section 8.4(g) .

(b) Subject to Section 11.4 , from and after the Closing, Buyer shall defend, indemnify and hold harmless the Stockholder Representative and the Pre-Closing Holders (collectively, the “ Seller Indemnified Parties ”) and will compensate and reimburse the Seller Indemnified Parties for any and all Losses incurred or suffered by any Seller Indemnified Party (regardless of whether such Losses relate to any Third-Party Claim) resulting from, relating to or constituting: (i) any breach of any representation or warranty Buyer or Merger Subs has made in this Agreement or in the Buyer Closing Certificate or (ii) any breach by (A) Buyer or Merger Subs of any covenant or agreement of Buyer or Merger Subs in this Agreement or (B) the Company of any covenant or agreement of the Company in this Agreement that, by its terms, provides for performance by the Company after the Closing.

(c) The amount of indemnification to which an Indemnified Party shall be entitled under this Article XI shall be determined: (i) by the written agreement between the Indemnified Party and the Indemnitor; (ii) by a final judgment or decree of any court of competent jurisdiction; or (iii) by any other means to which the Indemnified Party and the Indemnitor shall agree. The judgment or decree of a court shall be deemed final when the time for appeal, if any, shall have expired and no appeal shall have been taken or when all appeals taken shall have been finally determined. The Indemnified Party shall have the burden of proof in establishing the amount of Losses suffered by it.

11.3 Indemnification Claim Procedures .

(a) If any Action is commenced or threatened by a third party that may give rise to a claim for indemnification (an “ Third-Party Claim ”) by any Person entitled to indemnification under this Agreement (each, an “ Indemnified Party ”), then such Indemnified Party shall promptly (i) notify the Indemnitor and (ii) deliver to the Indemnitor a written notice (A) describing in reasonable detail the nature of the Action, (B) including a copy of all papers served with respect to such Action, (C) including the Indemnified Party’s good faith estimate of the amount of Losses that may arise from such Action, and (D) describing in reasonable detail the basis for the Indemnified Party’s request for indemnification under this Agreement. Failure to notify the Indemnitor in accordance with this Section 11.3(a) will not relieve the Indemnitor of any liability that it may have to the Indemnified Party, except to the extent (1) the defense of such Action is prejudiced by the Indemnified Party’s failure to give such notice or (2) the Indemnified Party fails to notify the Indemnitor of such Third-Party Claim in accordance with this Section 11.3(a) prior to the Survival Expiration Date.

(b) An Indemnitor may elect at any time to assume and thereafter conduct the defense of any Action subject to any such Third-Party Claim with counsel of the Indemnitor’s choice and each Indemnified Party shall cooperate in all respects with the conduct of such defense by the Indemnitor (including the making of any related claims, counterclaim or cross complaint against any Person in connection with the Action) and the settlement of such Action by the Indemnitor; provided further , that (i) the Stockholder Representative may only assume control of such defense if (A) the maximum amount of Losses related to such Third-Party Claim, taken together with the

estimated costs of defense thereof and the Claimed Amount with respect to any unresolved claims for indemnification then pending, is less than or equal to the current market value of the available Holdback Shares (calculated based on the volume weighted average price of a Buyer Ordinary Share over the twenty (20) trading-day period ending three (3) trading days prior to the date of such determination, as reported by Bloomberg), and (B) it acknowledges in writing to the Buyer on behalf of all of the Pre-Closing Holders that any damages, fines, costs or other liabilities that may be assessed against the Buyer in connection with such Third Party Claim constitute Losses for which the Buyer shall be indemnified pursuant to this Article XI, and (ii) the Stockholder Representative may not assume control of (but may participate in, at its sole cost and expense) the defense of any Third-Party Claim involving Taxes, any Governmental Authority or criminal liability or in which equitable relief is sought against the Buyer or any of its subsidiaries; provided , further that the Indemnitor will not approve of the entry of any judgment or enter into any settlement or compromise with respect to such Action without the Indemnified Party’s prior written approval (which must not be unreasonably withheld or delayed), unless the terms of such settlement provide for a complete release of the claims that are the subject of such Action in favor of the Indemnified Party. If the Indemnified Party gives an Indemnitor notice of a Third-Party Claim and either (A) the Indemnitor does not, within sixty (60) days after such notice is given, (i) give notice to the Indemnified Party of its election to assume the defense of the Action or Actions subject to such Third-Party Claim and (ii) thereafter promptly assume such defense, (B) the Stockholder Representative is the Indemnitor and the Indemnitor’s reasonable assessment of the likely maximum amount of Losses related to such Action is greater than the current market value (calculated based on the volume weighted average price of a Buyer Ordinary Share over the twenty (20) trading-day period ending three (3) trading days prior to the date of such determination, as reported by Bloomberg) of the available Holdback Shares and not otherwise subject to a claim for indemnification under this Article XI or (C) the Indemnitor does not otherwise have the right to assume defense of such Third-Party Claim under the terms of this Article XI , then the Indemnified Party may conduct the defense of such Action; provided , however , that the Indemnified Party will not agree to the entry of any judgment or enter into any settlement or compromise with respect to such Action or Actions without the prior written consent of the Indemnitor (which consent shall not be unreasonably withheld).

(c) In circumstances where the Indemnitor assumes the defense of a Third-Party Claim in accordance with Section 11.3(b) , the Indemnified Party shall be entitled to participate in the defense of such Third-Party Claim and to employ separate counsel of its choice for such purpose, in which case the fees and expenses of such separate counsel shall be borne by such Indemnified Party.

(d) If any Indemnified Party becomes aware of any circumstances that may give rise to claim for indemnification for any matter not involving a Third-Party Claim, then such Indemnified Party shall promptly (i) notify the Indemnitor and (ii) deliver to the Indemnitor a written notice (A) describing in reasonable detail the nature of the circumstances giving rise to such claim, (B) including the Indemnified Party’s good faith estimate of the amount of Losses that may arise from such circumstances, and (C) describing in reasonable detail the basis for the Indemnified Party’s request for indemnification under this Agreement. Failure to notify the Indemnitor in accordance with this Section 11.3(d) will not relieve the Indemnitor of any liability that it may have to the Indemnified Party, except to the extent (1) the defense of such claim is prejudiced by the Indemnified Party’s failure to give such notice or (2) the Indemnified Party fails

to notify the Indemnitor of such claim in accordance with this Section 11.3(d) prior to the Survival Expiration Date. If the Indemnitor disputes its indemnity obligations for any Losses with respect to any such claim, the parties shall proceed in good faith to negotiate a resolution of such dispute and, if not resolved through negotiations, such dispute shall be resolved by litigation in an appropriate court of jurisdiction determined pursuant to Section 13.14 .

(e) At the reasonable request of the Indemnitor, each Indemnified Party shall grant the Indemnitor and its representatives all reasonable access to the books, records, employees and properties of such Indemnified Party to the extent reasonably related to the matters to which the applicable claim for indemnification relates. All such access shall be granted during normal business hours and shall be granted under the conditions which shall not unreasonably interfere with the business and operations of such Indemnified Party.

11.4 Limitations on Indemnification Liability . Notwithstanding any provision of this Agreement to the contrary, any claims an Indemnified Party makes under this Article XI will be limited as follows:

(a) Indemnification Cap . Claims for indemnification under Section 11.2(a) and Section 11.2(b) shall, if applicable, be subject to the limitations set forth in this Section 11.4 , and then, with respect to claims under Section 11.2(a) , such claims for indemnification shall be satisfied (i) first, from the Holdback Shares, for as long as Holdback Shares remain available to cover the Buyer Indemnified Parties’ indemnifiable Losses and (ii) thereafter, solely for claims in respect of (A) any Fundamental Representations, (B) in cases of fraud or (C) under clauses (ii) through (vi) of Section 11.2(a) , from Buyer’s right of set-off (if then available) in accordance with Section 11.5 . Recovery (1) from the Holdback Shares shall serve as the sole and exclusive source of indemnification from which the Buyer Indemnified Parties may collect Losses for which they are entitled to indemnification from the Pre-Closing Holders under Section 11.2(a)(i) (other than for breaches of Fundamental Representations), and (2) from the Holdback Shares and from Buyer’s right of set-off under Section 11.5 shall serve as the sole and exclusive source of indemnification from which the Buyer Indemnified Parties may collect Losses for which they are entitled to indemnification from the Pre-Closing Holders in respect of any Fundamental Representations under Section 11.2(a)(i) , in cases of fraud and under clauses (ii) through (vi) of Section 11.2(a) . The aggregate liability of any Pre-Closing Holder under Section 11.2(a) shall not exceed the aggregate amount of Final Merger Consideration paid or becomes due and payable to such Pre-Closing Holder under this Agreement. The aggregate liability of the Buyer (x) under Section 11.2(b)(i) , other than for breaches of Fundamental Representations, shall not exceed a cash amount equal to the number of Holdback Shares multiplied by the Buyer Share Price, and (y) under Section 11.2(b) shall not exceed the Final Merger Consideration that is paid or becomes due and payable under this Agreement.

(b) Claims Basket . The Buyer Indemnified Parties shall not be entitled to indemnification pursuant to Section 11.2(a)(i) (except for claims based on fraud, intentional or knowing misrepresentation or willful breach, and except for claims for breaches of Fundamental Representations) unless and until the aggregate amount of all Losses incurred by the Buyer Indemnified Parties for which the Buyer Indemnified Parties are entitled to indemnification pursuant to this Article XI exceeds a dollar amount equal to the product of (A) three quarters of one percent (0.75%) multiplied by (B) the Base Shares multiplied by (C) the Buyer Share Price

(the “ Basket Amount ”), and the Buyer Indemnified Parties shall only be entitled to indemnification for such Losses to the extent such Losses exceed the Basket Amount. The Seller Indemnified Parties shall not be entitled to indemnification pursuant to this Article XI unless and until the aggregate amount of all Losses incurred by the Seller Indemnified Parties for which the Seller Indemnified Parties are entitled to indemnification pursuant to this Article XI exceeds the Basket Amount, and the Seller Indemnified Parties shall only be entitled to indemnification for such Losses to the extent such Losses exceed the Basket Amount.

(c) Losses Net of Insurance Proceeds, Tax Benefits and Other Third-Party Recoveries . All Losses for which any Indemnified Party would otherwise be entitled to indemnification under this Article XI shall be reduced by the amount of insurance proceeds to which any Indemnified Party actually received in respect of any Losses incurred by such Indemnified Party (net of all costs of collection and increases in insurance premiums). The amount of Losses recoverable by an Indemnified Party under this Article XI with respect to an indemnity claim shall be reduced by the amount of any tax savings actually realized by such Indemnified Party, or any Affiliate thereof, for the tax year in which such Losses are incurred and all prior tax years, which are clearly attributable to the Losses to which such indemnity claim relates, net of (i) all costs or expenses incurred by the Indemnified Party in connection with realizing such amount, (ii) any increased tax liability which may result from the receipt of the indemnity payment relating to such Losses and (iii) any reduction in or offset to any other tax savings or benefit otherwise available to such Indemnified Party or any Affiliate thereof. In the event that any insurance or other recovery is made by any Buyer Indemnified Party with respect to any Loss for which such Buyer Indemnified Party has been indemnified hereunder, then a refund equal to the aggregate amount of the insurance or other recovery shall be made promptly by such Buyer Indemnified Party to the Exchange Agent for distribution to the Pre-Closing Holders ( provided , that amounts payable in respect of Company Options shall be paid to the Final Surviving Corporation for payment through its payroll system) in accordance with such Pre-Closing Holders’ Pro Rata Share of such amount.

(d) Assignment of Claims . If any Indemnified Party receives any indemnification payment pursuant to this Article XI , at the election of the Indemnitor, such Indemnified Party shall assign to the Indemnitor all of its claims for recovery against third Persons as to such Losses, whether by insurance coverage, contribution claims, subrogation or otherwise.

(e) Consequential, Punitive and Certain Other Damages . Notwithstanding anything to the contrary contained herein, with respect to indemnification pursuant to Section 11.2 (other than claims based on fraud, intentional or knowing misrepresentation or willful breach), no Losses shall be recoverable under this Article XI that constitute punitive, consequential, incidental, indirect or special damages or lost profits, unless such Losses (i) are required to be paid to a third party pursuant to a Third-Party Claim for which the Indemnified Parties were entitled to indemnification pursuant to this Article XI and such claim for indemnification was actually made or (ii) except for punitive damages, were reasonably foreseeable as of the date hereof and result proximately from the breach giving rise to such Losses.

(f) No Duplicate Claims . In the event a Buyer Indemnified Party or Seller Indemnified Party, as the case may be, recovers Losses in respect of a claim for indemnification, no other Buyer

Indemnified Party or Seller Indemnified Party, as applicable, may recover the same Losses in respect of a claim for indemnification under this Agreement.

(g) Materiality Qualifications . Notwithstanding anything to the contrary in this Agreement, for purposes of determining the amount of Losses for which any Buyer Indemnified Party may be entitled to indemnification under this Article XI (but not in determining the existence of a breach of any representation or warranty), each such representation or warranty shall be deemed to have been made without any qualifications or limitations as to materiality (including any qualifications or limitations made by reference to a Material Adverse Effect).

11.5 Set Off . Notwithstanding anything to the contrary in this Agreement, with respect to any claim for indemnification in respect of (A) any Fundamental Representations pursuant to Section 11.2(a)(i) , (B) in cases of fraud and (C) under clauses (ii) through (vi) of Section 11.2(a) , and only to the extent that the Holdback Shares are no longer available to satisfy such claims, Buyer shall have the right, but not the obligation, to set off, in whole or in part, against any Milestone Payment that becomes due and payable (but not to the extent previously paid) any amounts owed or claimed in good faith to be owed by any Pre-Closing Holder to any Buyer Indemnified Party pursuant to this Agreement or any other agreement delivered in connection herewith. Any Buyer Ordinary Share that becomes subject to such set-off right shall be valued in accordance with Section 3.10(g).

11.6 Holdback Shares . Buyer may reduce the number of Buyer Ordinary Shares constituting the Holdback Shares to account for any Losses indemnifiable pursuant to this Article XI accrued and finally determined prior to the time Buyer is otherwise required to deliver such Holdback Shares pursuant Section 11.8 . Each Buyer Ordinary Share held as a Holdback Share shall be deemed to have a value equal to the volume weighted average price of a Buyer Ordinary Share over the twenty (20) trading-day period ending three (3) trading days prior to the date of release or retention by Buyer of such shares, as reported by Bloomberg.

11.7 Indemnification Sole and Exclusive Remedy . Except with respect to claims based on fraud and claims for specific performance of covenants, following the Closing, indemnification pursuant to this Article XI shall be the sole and exclusive remedy of the parties and any parties claiming by or through any party (including the Indemnified Parties) related to or arising from any breach of any representation, warranty, covenant or agreement contained in, or otherwise pursuant to, this Agreement and none of Buyer, Merger Subs, the Company, the Stockholder Representative or any Pre-Closing Holder shall have any other rights or remedies in connection with any breach of this Agreement or any other liability arising out of the negotiation, entry into or consummation of the transactions contemplated by this Agreement, whether based on contract, tort, strict liability, other Laws or otherwise; provided that no provision of this sentence shall operate as a release of any Pre-Closing Holder from any claim against or liability of such Pre-Closing Holder under any Contract delivered by such Pre-Closing Holder to Buyer or any Merger Sub in connection with this Agreement or the transactions contemplated hereby.

11.8 Issuance of Holdback Shares . The Buyer Ordinary Shares constituting Holdback Shares (to the extent so remaining) shall be issued to the Company Stockholders in accordance with the Payment Spreadsheet on the first Business Day following the first anniversary of the Closing Date (the “ Holdback Issuance Date ”); provided , however , that if any claim pursuant to

this Article XI shall have been properly asserted by any Buyer Indemnified Party in accordance with this Agreement on or prior to the Survival Expiration Date and remain pending on the Holdback Issuance Date (any such claim, a “ Pending Claim ”), (i) the number of Holdback Shares issued to the Company Stockholders shall be the amount of Holdback Shares, minus that number of Holdback Shares that is equal to the aggregate amount of such Pending Claim divided by the volume weighted average price of a Buyer Ordinary Share over the twenty (20) trading-day period ending three (3) trading days prior such date of issuance and (ii) any Buyer Ordinary Shares that remain as Holdback Shares following the Holdback Issuance Date in respect of any such Pending Claim shall be issued to the Company Stockholders in accordance with the Payment Spreadsheet promptly upon resolution or (if applicable) satisfaction of such Pending Claim to the extent the number of Holdback Shares is not reduced upon satisfaction of such Pending Claim pursuant to Section 11.6 ; provided , in any event, that with respect to Holdback Shares that would otherwise be issuable pursuant to this Section 11.8 to Company Stockholders that are Cash-Out Holders, in lieu of issuing such Holdback Shares to such Cash-Out Holders, Buyer shall retain such Holdback Shares and pay to such Cash-Out Holders in lieu thereof an amount in cash equal to the number of such Holdback Shares multiplied the volume weighted average price of a Buyer Ordinary Share over the twenty (20) trading-day period ending three (3) trading days prior to the date of such payment, as reported by Bloomberg.

11.9 Tax Treatment . All amounts paid with respect to claims for indemnification under Article XI of this Agreement shall be treated by the parties hereto for all Tax purposes as adjustments to the Closing Merger Consideration to the greatest extent permitted by applicable Law, and shall be reported as such by the parties hereto on their Tax Returns.

ARTICLE XII.
STOCKHOLDER REPRESENTATIVE

12.1 Designation and Replacement of Stockholder Representative . The parties hereto have agreed that it is desirable to designate a representative to act on behalf of holders of the Company Capital Stock, Company Options and the Company Warrant, as the exclusive agent and attorney-in-fact for and on behalf of such Persons, for certain limited purposes, as specified herein (the “ Stockholder Representative ”). The Company has designated Cam Gallagher as the initial Stockholder Representative, and requisite approval of this Agreement by the holders of Company Common Stock shall constitute ratification and approval of such designation. The Stockholder Representative may resign at any time, and the Stockholder Representative may be removed by the vote of Persons which collectively owned more than fifty percent (50%) of the outstanding shares of Company Common Stock and which collectively owned more than fifty percent (50%) of the outstanding shares of Company Series A Preferred Stock, in each case, as of immediately prior to the Effective Time (or, in the case of a termination of this Agreement, as of such termination) (the “ Majority Holders ”). In the event that a Stockholder Representative has resigned or been removed, a new Stockholder Representative shall be appointed by a vote of the Majority Holders, such appointment to become effective upon the written acceptance thereof by the new Stockholder Representative. The designation of any Person as the Stockholder Representative is and shall be considered a power of attorney coupled with an interest, and, except as set forth in this Article XII , such designation is irrevocable and shall not be affected by the death, incapacity, illness, bankruptcy, dissolution or other inability to act of any of the holders of Company Capital Stock, Company Options or the Company Warrant.

12.2 Authority and Rights of the Stockholder Representative; Limitations on Liability . The Stockholder Representative shall have such powers and authority as are necessary to carry out the functions assigned to it under this Agreement; provided , however , that the Stockholder Representative shall have no obligation to act, except as expressly provided herein. Without limiting the generality of the foregoing, the Stockholder Representative shall have full power, authority and discretion to (i) give and receive notices and communications on behalf of the Pre-Closing Holders, (ii) estimate and determine the amounts of Stockholder Representative Expenses and to pay such Stockholder Representative Expenses in accordance with Section 3.5 , (iii) to determine the occurrence of any Milestone, (iv) resolve on behalf of the Pre-Closing Holders any disputes related to (A) the occurrence of any Milestone or the payment of any Milestone Payment, (B) the adjustment of the Closing Merger Consideration in accordance with Section 3.4 or (C) any indemnification in accordance with Article XI , (v) commence litigation in accordance with the terms of this Agreement and to comply with Governmental Orders and awards of any arbitrators related thereto, and to settle any such disputes on behalf of the Pre-Closing Holders, (vi) after the Closing, update the Payment Spreadsheet in accordance with Section 3.1(e) and (vii) after the Closing, negotiate and enter into amendments to this Agreement for and on behalf of the Pre-Closing Holders. All actions taken by the Stockholder Representative in accordance with this Agreement shall be binding upon the Pre-Closing Holders and their successors as if expressly confirmed and ratified in writing by each of them. The Stockholder Representative shall have no liability to Buyer, the Company or any holder of Company Capital Stock, Company Options or the Company Warrant with respect to actions taken or omitted to be taken in good faith in its capacity as the Stockholder Representative (except for those arising out of the Stockholder Representative’s gross negligence or willful misconduct). The Stockholder Representative shall at all times be entitled to rely on any directions received from the Majority Holders; provided , however , that the Stockholder Representative shall not be required to follow any such direction, and shall be under no obligation to take any action in its capacity as the Stockholder Representative, unless the Stockholder Representative is holding funds delivered to it under Section 3.5 and has been provided with other funds, security or indemnities which, in the sole determination of the Stockholder Representative, are sufficient to protect the Stockholder Representative against the costs, expenses and liabilities which may be incurred by the Stockholder Representative in responding to such direction or taking such action. The Stockholder Representative shall be entitled to engage such counsel, experts and other agents and consultants as it shall deem necessary in connection with exercising its powers and performing its function hereunder and (in the absence of bad faith on the part of the Stockholder Representative) shall be entitled to conclusively rely on the opinions and advice of such Persons. The Stockholder Representative shall be entitled to reimbursement for all Stockholder Representative Expenses solely from the Stockholder Representative Expense Fund. The Stockholder Representative shall be entitled to indemnification by the Pre-Closing Holders against any loss, liability or expenses arising out of actions taken or omitted to be taken in good faith in its capacity as the Stockholder Representative (except for those arising out of the Stockholder Representative’s gross negligence or willful misconduct), including the costs and expenses of investigation and defense of claims.

ARTICLE XIII.
MISCELLANEOUS

13.1 Waiver . Any party to this Agreement may, at any time prior to the Closing, by action taken by its Board of Directors, or officers thereunto duly authorized, waive any of the terms or

conditions of this Agreement or (without limiting Section 13.11 ) agree to an amendment or modification to this Agreement by an agreement in writing executed in the same manner (but not necessarily by the same Persons) as this Agreement. No waiver by any of the parties hereto of any default, misrepresentation or breach of representation, warranty, covenant or other agreement hereunder, whether intentional or not, shall be deemed to extend to any prior or subsequent default, misrepresentation or breach or affect in any way any rights arising by virtue of any prior or subsequent such occurrence. No waiver by any of the parties of any of the provisions hereof shall be effective unless explicitly set forth in writing and executed by the party sought to be charged with such waiver.

13.2 Notices . All notices and other communications among the parties shall be in writing and shall be deemed to have been duly given (i) when delivered in person, (ii) when delivered after posting in the United States mail having been sent registered or certified mail return receipt requested, postage prepaid, (iii) when delivered by FedEx or other nationally recognized overnight delivery service, or (iv) when delivered by facsimile or email (in each case in this clause (iv), solely if receipt is confirmed), addressed as follows:

(a) If to Buyer, Merger Subs or the Final Surviving Corporation, to:

Nabriva Therapeutics plc
1000 Continental Drive, Suite 600
King of Prussia, Pennsylvania 19406
Attention:	Robert Crotty, General Counsel
Email:	robert.crotty@nabriva.com

with copies (which shall not constitute notice) to:

Wilmer Cutler Pickering Hale and Dorr LLP
7 World Trade Center
250 Greenwich Street
New York, New York 10007
Attention:	Brian A. Johnson, Esq.
Telecopy:	(212) 230-8888

Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, Massachusetts 02109
Attention:	Joseph B. Conahan, Esq.
Telecopy:	(617) 526-5000

(b) If to the Company, prior to the Closing, to:

Zavante Therapeutics, Inc.
11750 Sorrento Valley Road, Suite 250
San Diego, California 92121
Attention:	Theodore R. Schroeder
	Kevin P. Finney
Email: tschroeder@zavante.com; kfinney@zavante.com

with copies (which shall not constitute notice) to:

Latham & Watkins LLP
12670 High Bluff Drive
San Diego, California 92130
Attention:	Cheston J. Larson
	Kevin C. Reyes
Facsimile No.: (858)-523-5450
Email: cheston.larson@lw.com; kevin.reyes@lw.com

and to the Stockholder Representative:

Cam Gallagher
8049 Run of the Knolls
San Diego, CA 92127
Email: gallaghercam@yahoo.com

Cam Gallagher
8049 Run of the Knolls
San Diego, CA 92127
Email: gallaghercam@yahoo.com

with a copy (which shall not constitute notice) to:

Latham & Watkins LLP
12670 High Bluff Drive
San Diego, California 92130
Attention:	Cheston J. Larson
	Kevin C. Reyes
Facsimile No.: (858)-523-5450
Email: cheston.larson@lw.com; kevin.reyes@lw.com

or to such other address or addresses as the parties may from time to time designate in writing.

13.3 Assignment . No party hereto shall assign this Agreement or any part hereof without the prior written consent of the other parties, except that Buyer may assign this Agreement without the consent of the other parties to any Successor Entity (which shall be in accordance with Section 3.10(f) , if applicable), in which case, only if such Successor Entity agrees in writing to assume and perform each of the obligations of Buyer in this Agreement, Buyer shall cease to have any further obligations under this Agreement. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns.

13.4 Rights of Third Parties . Nothing expressed or implied in this Agreement is intended or shall be construed to confer upon or give any Person, other than the parties hereto, any right or remedies under or by reason of this Agreement; provided , however , that, notwithstanding the foregoing (i) in the event the Closing occurs, the Indemnified Persons (and their successors, heirs and representatives) are intended third-party beneficiaries of, and may enforce, Section 7.1 , (ii) from and after the Effective Time, the Pre-Closing Holders (and their successors, heirs and representatives) shall be intended third-party beneficiaries of, and may enforce, Article II and Article III , and (iii) Prior Company Counsel and the Designated Persons shall be intended third-party beneficiaries of, and may enforce, Section 13.16 .

13.5 [Reserved].

13.6 Expenses . Each party hereto, other than the Stockholder Representative (whose expenses shall be paid out of the Stockholder Representative Expense Fund pursuant to Section 3.5 ), shall bear its own expenses incurred in connection with this Agreement and the transactions contemplated hereby whether or not such transactions shall be consummated, including all fees of its legal counsel, financial advisers and accountants; provided , however , that the fees and expenses of the Independent Auditor, if any, shall be paid in accordance with Section 3.4 ; provided further that, in the event that the transactions contemplated hereby are not consummated, (i) the Company shall reimburse the Stockholder Representative for all costs and expenses incurred by the Stockholder Representative in connection with the transactions contemplated hereby, and (ii) Buyer shall pay all fees and expenses in connection with any financing arrangements of Buyer, regardless of whether such fees and expenses were to be incurred by the Company.

13.7 Governing Law . This Agreement, and all claims or causes of action based upon, arising out of, or related to this Agreement or the transactions contemplated hereby, shall be governed by, and construed in accordance with, the Laws of the State of Delaware, without giving effect to principles or rules of conflict of laws to the extent such principles or rules would require or permit the application of Laws of another jurisdiction.

13.8 Captions; Counterparts . The captions in this Agreement are for convenience only and shall not be considered a part of or affect the construction or interpretation of any provision of this Agreement. 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. Counterparts and any other document required to be executed and delivered hereunder may be delivered via facsimile, electronic mail (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000 (e.g., www.docusign.com)) or other transmission method and any counterpart or such document so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

13.9 Schedules and Annexes . The Disclosure Schedules and Annexes referenced herein are a part of this Agreement as if fully set forth herein. All references herein to the Disclosure Schedules and Annexes shall be deemed references to such parts of this Agreement, unless the context shall otherwise require. The Disclosure Schedule delivered by the Company under Article IV shall be arranged in sections and paragraphs corresponding to the numbered and lettered sections and paragraphs contained in Article IV . Any disclosure made by a party in the Disclosure Schedules with reference to any section or schedule of this Agreement shall be deemed to be a disclosure

with respect to all other sections or schedules to which the relevance of such disclosure is reasonably apparent based on a reading of the disclosure. Certain information set forth in the Disclosure Schedules is included solely for informational purposes and may not be required to be disclosed pursuant to this Agreement. The disclosure of any information shall not be deemed to constitute an acknowledgment that such information is required to be disclosed in connection with the representations and warranties made in this Agreement, nor shall such information be deemed to establish a standard of materiality.

13.10 Entire Agreement . This Agreement (together with the Disclosure Schedules and Annexes to this Agreement) and that certain Mutual Confidentiality Agreement, dated as of October 31, 2017, between Nabriva Therapeutics Ireland DAC, an Irish designated activity company, and the Company (the “ Confidentiality Agreement ”), constitute the entire agreement among the parties relating to the transactions contemplated hereby and supersede any other agreements, whether written or oral, that may have been made or entered into by or among any of the parties hereto or any of their respective Subsidiaries relating to the transactions contemplated hereby. No representations, warranties, covenants, understandings or agreements, oral or otherwise, relating to the transactions contemplated by this Agreement exist between the parties, except as expressly set forth in this Agreement and the Confidentiality Agreement.

13.11 Amendments . This Agreement may be amended or modified in whole or in part, only by a duly authorized agreement in writing executed in the same manner as this Agreement and which makes reference to this Agreement. The approval of this Agreement by the stockholders of the Company shall not restrict the ability of the Board of Directors of the Company to terminate this Agreement in accordance with Section 10.1 or to cause the Company to enter into an amendment to this Agreement pursuant to this Section 13.11 to the extent permitted under Section 251(d) of the DGCL.

13.12 Publicity . The Company and Buyer agree that, from the date hereof through the Closing Date, the Company shall not make any public release or announcement concerning the transactions contemplated hereby shall be issued or made by or on behalf of any party without the prior consent of the other parties, except that the Company may make any disclosures or announcements necessary to comply with applicable Law or securities exchange regulations, including, if applicable, filing a copy of this Agreement with the United States Securities and Exchange Commission or similar Governmental Authority. The Company and Buyer and Merger Subs agree to keep the terms of this Agreement confidential, except to the extent and to the Persons to whom disclosure is required by applicable Law or securities exchange regulation or for purposes of compliance with financial reporting obligations; provided , that the parties may disclose such terms to their respective employees, accountants, advisors and other representatives as necessary in connection with the ordinary conduct of their respective businesses (so long as such Persons agree to, or are bound by contract or professional or fiduciary obligations to, keep the terms of this Agreement confidential and so long as the parties shall be responsible to the other parties hereto for breach of this Section 13.12 or such confidentiality obligations by the recipients of its disclosure).

13.13 Severability . If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement shall remain in full force and effect. The parties further agree that if any provision contained herein is, to any extent, held

invalid or unenforceable in any respect under the Laws governing this Agreement, they shall take any actions necessary to render the remaining provisions of this Agreement valid and enforceable to the fullest extent permitted by Law and, to the extent necessary, shall amend or otherwise modify this Agreement to replace any provision contained herein that is held invalid or unenforceable with a valid and enforceable provision giving effect to the intent of the parties.

13.14 Jurisdiction; Waiver of Jury Trial .

(a) Any Action based upon, arising out of or related to this Agreement or the transactions contemplated hereby may be brought in the Delaware Chancery Court (or, if the Delaware Chancery Court shall be unavailable, any other court of the State of Delaware or, in the case of claims to which the federal courts have exclusive subject matter jurisdiction, any federal court of the United States of America sitting in the State of Delaware), and, in each case, appellate courts therefrom, and each of the parties irrevocably submits to the exclusive jurisdiction of each such court in any such Action, waives any objection it may now or hereafter have to personal jurisdiction, venue or to convenience of forum, agrees that all claims in respect of such Action shall be heard and determined only in any such court, and agrees not to bring any Action arising out of or relating to this Agreement or the transactions contemplated hereby in any other court. Nothing herein contained shall be deemed to affect the right of any party to serve process in any manner permitted by Law or to commence legal proceedings or otherwise proceed against any other party in any other jurisdiction, in each case, to enforce judgments obtained in any Action brought pursuant to this Section 13.14(a) .

(b) Each party hereto hereby waives, to the fullest extent permitted by applicable Law, any right it may have to a trial by jury in respect of any Action arising out of this Agreement or the transactions contemplated hereby. Each party hereto (i) certifies that no representative, agent or attorney of any other party has represented, expressly or otherwise, that such party would not, in the event of any Action, seek to enforce the foregoing waiver and (ii) acknowledges that it and the other parties hereto have been induced to enter into this Agreement by, among other things, the mutual waiver and certifications in this Section 13.14(b) .

13.15 Enforcement . The parties hereto agree that irreparable damage would occur, and that the parties would not have any adequate remedy at law, in the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to specifically enforce the terms and provisions of this Agreement, without proof of actual damages or otherwise, in addition to any other remedy to which any party is entitled at law or in equity. Each party agrees to waive any requirement for the securing or posting of any bond in connection with such remedy. The parties further agree not to assert that a remedy of specific enforcement is unenforceable, invalid, contrary to Law or inequitable for any reason, nor to assert that a remedy of monetary damages would provide an adequate remedy. To the extent any party hereto brings an Action to enforce specifically the performance of the terms and provisions of this Agreement (other than an Action to enforce specifically any provision that by its terms requires performance after the Closing or expressly survives termination of this Agreement), the Outside Date shall automatically be extended to (i)

the twentieth (20th) Business Day following the resolution of such Action or (ii) such other time period established by the court presiding over such Action.

13.16 Waiver of Conflicts Regarding Representations; Non-Assertion of Attorney-Client Privilege .

(a) Conflicts of Interest . Buyer acknowledges that Latham & Watkins LLP (“ Prior Company Counsel ”) has, on or prior to the Closing Date, represented one or more of the Stockholder Representative, one or more Pre-Closing Holders, the Company and other Affiliates, and their respective officers, employees and directors (each such Person, other than the Company, a “ Designated Person ”) in one or more matters relating to this Agreement or any other agreements or transactions contemplated hereby (including any matter that may be related to a litigation, claim or dispute arising under or related to this Agreement or such other agreements or in connection with such transactions) (each, an “ Existing Representation ”), and that, in the event of any post-Closing matters relating to this Agreement or any other agreements or transactions contemplated hereby (each, a “ Post-Closing Matter ”), the Designated Persons may request that Prior Company Counsel represent them in connection with such matters (including matters which may be adverse to Buyer or its Affiliates). Accordingly, each of Buyer and the Company hereby (i) waives and shall not assert, and agrees after the Closing to cause its Affiliates to waive and to not assert, any conflict of interest arising out of or relating to the representation by Prior Company Counsel of one or more Designated Persons in connection with one or more Post-Closing Matters (the “ Post-Closing Representations ”) , and (ii) agrees that, in the event that a Post-Closing Matter arises, Prior Company Counsel may represent one or more Designated Persons in Post-Closing Matter even though the interests of such Person(s) may be directly adverse to Buyer or any of its Affiliates (including the Company), and even though Prior Company Counsel may (i) have represented the Company in a matter substantially related to such dispute or (ii) be currently representing Buyer, the Company or any of their respective Affiliates.

(b) Attorney-Client Privilege . Each of Buyer and the Company (on behalf of itself and its Affiliates) waives and shall not assert, and agrees after the Closing to cause its Affiliates to waive and to not assert, any attorney-client privilege, attorney work-product protection or expectation of client confidence with respect to any communication between any Prior Company Counsel, on the one hand, and any Designated Person or the Company (collectively, the “ Pre-Closing Designated Persons ”), or any advice given to any Pre-Closing Designated Person by any Prior Company Counsel, solely to the extent occurring during (and relating to) one or more Existing Representations (collectively, “ Pre-Closing Privileges ”) in connection with any Post-Closing Representation, including matters that may be adverse to Buyer or the Company (after the Effective Time) or their Affiliates. Notwithstanding the foregoing and Section 13.16(c) , in the event that a dispute arises between Buyer or the Company (after the Effective Time), on the one hand, and a third party other than a Designated Person, on the other hand, the Company shall (and shall cause its Affiliates to ) assert the Pre-Closing Privileges on behalf of the Designated Persons to prevent disclosure of Privileged Materials to such third party; provided , however that such privilege may be waived only with the prior written consent of the Stockholder Representative.

(c) Privileged Materials . All Pre-Closing Privileges, and all books and records and other documents of the Company containing any advice or communication that is subject to any Pre-Closing Privilege (“ Privileged Materials ”), shall be excluded from the purchase, and shall be distributed to the Stockholder Representative (on behalf of the applicable Designated Persons) immediately prior to the Closing with (in the case of such books and records) no copies retained by the Company. Absent the prior written consent of the Stockholder Representative, neither Buyer nor (following the Closing) the Company shall have a right of access to Privileged Materials.

13.17 Tax Advice . Each party hereto acknowledges and agrees that it has not received and is not relying upon Tax advice from any other party hereto, and that it has and will continue to consult its own advisors with respect to Taxes.

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IN WITNESS WHEREOF the parties have hereunto caused this Agreement to be duly executed as of the date first above written.

	NABRIVA THERAPEUTICS PLC


	By:	/s/ Colin Broom
	Name:	Colin Broom
	Title:	Chief Executive Officer


	ZUPERBUG MERGER SUB I, INC.


	By:	/s/ Colin Broom
	Name:	Colin Broom
	Title:	CEO & President


	ZUPERBUG MERGER SUB II, INC.


	By:	/s/ Colin Broom
	Name:	Colin Broom
	Title:	CEO & President


	ZAVANTE THERAPEUTICS, INC.


	By:	/s/ Theodore R. Schroeder
	Name:	Theodore R. Schroeder
	Title:	President & Chief Executive Officer


	Cam Gallagher, solely in his capacity as the initial Stockholder Representative hereunder


	By:	/s/ Cam Gallagher
	Name:	Cam Gallagher
	Title:	Stockholder Representative

ANNEX A

FORM OF SUPPORT AGREEMENT

ANNEX B-1

FORM OF CERTIFICATE OF MERGER

ANNEX B-2

FORM OF SECOND CERTIFICATE OF MERGER

ANNEX C

FORM OF LETTER OF TRANSMITTA L

ANNEX D

FORM OF INVESTMENT AGREEMENT

ANNEX E

FORM OF WRITTEN CONSENT

ANNEX F

FORM OF SURRENDER AGREEMENT

Exhibit 10.1

TRANSITION, SEPARATION AND RELEASE OF CLAIMS AGREEMENT

This Transition, Separation and Release of Claims Agreement (the “ Agreement ”) is made as of the Agreement Effective Date (as defined below) between Nabriva Therapeutics US, Inc. (the “ Company ”) and Colin Broom (“ Executive ”) (together, the “ Parties ”). The Parties agree that this Agreement is contingent on the closing of the transaction (the “ Closing ”) contemplated by the Agreement and Plan of Merger dated as of July 23, 2018 (the “ Purchase Agreement ”) by and among Nabriva Therapeutics plc (the “ Parent ”), Zuperbug Merger Sub I, Inc., Zuperbug Merger Sub II, Inc., Zavante Therapeutics, Inc. and Cam Gallagher, solely in his capacity as the initial Stockholder Representative, and shall become effective as of the Closing. In the event the Closing does not occur, this Agreement shall have no further force and effect and shall be null and void.

RECITALS

WHEREAS , the Company and Executive are parties to the Amended and Restated Employment Agreement dated as of June 17, 2016 (the “ Employment Agreement ”), under which Executive currently serves as Chief Executive Officer of the Company and Chief Executive Officer of its group of companies;

WHEREAS , in conjunction with the Closing, the Parties have decided to end their employment relationship and wish to establish mutually agreeable terms for Executive’s orderly transition and separation from the Company effective as of and contingent upon the Closing; and

WHEREAS , the Parties agree that the payments, benefits and rights set forth in this Agreement shall be the exclusive payments, benefits and rights due Executive;

NOW, THEREFORE , in consideration of the mutual covenants and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

1. Transition Period, Separation Date; Continued Board Membership —

(a) Executive’s effective date of separation from employment with the Company and, as may be applicable, any and all of its parents, affiliates and subsidiaries, including, without limitation, Nabriva Therapeutics GMBH and the Parent (together, the “ Affiliates ”), will be the date of the Closing (the “ Separation Date ”). Executive hereby resigns, as of the Separation Date, from all of his positions as an employee and/or officer of the Company and each of its Affiliates, and as a director of the Company and each of its Affiliates, as applicable, except, in accordance with Section 1(d), as a director of the Parent. Executive further agrees to execute and deliver any documents reasonably necessary to effectuate such resignations, provided that nothing in any such document is inconsistent with any terms set forth in this Agreement. Notwithstanding the foregoing, the Company retains the right to terminate Executive’s employment prior to the Separation Date for Cause (as defined in the Employment Agreement).

(b) The period between the Agreement Effective Date and the Separation Date will be a

transition period (the “ Transition Period ”). During the Transition Period, Executive will remain the Company’s Chief Executive Officer and Chief Executive Officer of the Company’s group of companies and continue to perform on a full-time basis those duties consistent with his position and use his best efforts to professionally, timely and cooperatively perform such duties, as well as such additional transition duties as may be requested by and at the direction of the Board of Directors of the Parent (the “ Board ”), including, without limitation, assisting with the transition of his duties and responsibilities to a new Chief Executive Officer (collectively, the “ Transition Duties ”). During the Transition Period, Executive will continue to receive his current base salary, to participate in the Company’s benefit plans (pursuant to the terms and conditions of such plans) and to be entitled to vacation time in accordance with Company policy.

(c) Upon Executive’s last day of employment with the Company, Executive shall receive the Accrued Obligations (as defined in the Employment Agreement). As of Executive’s last day of employment, all salary payments from the Company will cease and any benefits Executive had as of such date under Company-provided benefit plans, programs, or practices will terminate, except as required by federal or state law or as otherwise specifically set forth in this Agreement.

(d) Following the Separation Date, Executive will continue to serve on the Board as a non-employee director. For so long as Executive serves as a non-employee director on the Board, he shall be entitled to compensation for such services in accordance with the Board’s Non-Employee Director Compensation Policy, as in effect from time to time; provided, however, that, due to his prior service as a director on the Board, he shall not be eligible to receive an “initial grant” of an option to purchase ordinary shares of the Parent in connection with his transition to non-employee director nor shall he be entitled to an “annual grant” of an option to purchase ordinary shares of the Parent at the Annual General Meeting of Shareholders to be held on August 1, 2018.

(e) Upon the Separation Date, the Company and Executive shall enter into a consulting agreement in the form attached to this Agreement as Attachment A (the “ Consulting Agreement ”).

2. Severance Benefits and Equity Benefits — In return for Executive’s timely signing this Agreement as set forth in Section 13 below, timely signing and not revoking the Additional Release of Claims attached hereto as Attachment B (the “ Additional Release ”) as set forth in Section 13 below, and subject to Executive’s compliance with all terms hereof, the Company will provide Executive with the following:

(a) Severance Benefits . The Company will provide Executive with the Severance Benefits described in and as defined by Section 8(b) of the Employment Agreement. Specifically, Executive shall be entitled to (i) continued payment, by the Company in accordance with the Company’s regularly established payroll procedure, of Executive’s current base salary for a period of eighteen months (which payments shall equal $707,301 in the aggregate); (ii) provided Executive is eligible for and timely elects to continue receiving group medical insurance pursuant to the “COBRA” law, continued payment for eighteen (18) months following the Separation Date, of the share of the premium for

health coverage that is paid by the Company for active and similarly-situated employees who receive the same type of coverage (unless the Company’s provision of such COBRA payments will violate the nondiscrimination requirements of applicable law, in which case these payments will not be made); and (iii) a prorated annual bonus for 2018, calculated by multiplying 100% of Executive’s current target bonus (i.e., $235,767) by a fraction, the numerator of which is equal to the number of days in 2018 during which Executive was employed by the Company and the denominator of which equals 365. Executive acknowledges and agrees that there are no earned but unpaid annual bonus amounts for a previously completed calendar year that would otherwise be paid to Executive pursuant to Section 8(b) of the Employment Agreement. The Severance Benefits will be paid or commence to be paid in the first regular payroll commencing with the first regular payroll date after the Additional Release Effective Date (as defined below). For the avoidance of doubt, the prorated annual bonus for 2018, as set forth in subsection (iii) above, shall be paid in a single lump sum on the date of the first regular payroll after the Additional Release Effective Date.

(b) Equity Benefits . Vested and unvested share options held by Executive as of the Separation Date (the “ 2018 Outstanding Options ”) will remain in full force and effect and will continue to be governed by the applicable option agreements and plan documents, subject to the following additional rights granted to Executive. Until the date that is twelve (12) months following the Separation Date (the “ Separation Anniversary ”), all 2018 Outstanding Options that are unvested as of the Separation Date (the “ Unvested 2018 Outstanding Options ”) will continue to vest so long as Executive remains a member of the Board; provided, however, that should Executive cease being a member of the Board prior to the Separation Anniversary, that portion of the Unvested 2018 Outstanding Options that would have vested had Executive remained on the Board through the Separation Anniversary shall accelerate (the “ Accelerated Options ”). Executive hereby acknowledges and agrees that except to the extent that the Unvested 2018 Outstanding Options become vested on or before the Separation Anniversary in accordance with the immediately preceding sentence, the Unvested 2018 Outstanding Options shall terminate on the Separation Anniversary (or his earlier cessation of services to the Board), whether or not he is then providing services to the Company under the Consulting Agreement, and be forfeited and he will have no further rights with respect thereto. Effective as of the Additional Release Effective Date, the Company will extend, until the later of (i) the date that is twenty-four (24) months following the Separation Date and (ii) the date that is three (3) months following the date that Executive’s Board membership ceases, the exercise period for the 2018 Outstanding Options that are, or become on or before the Separation Anniversary, vested (but in no event shall such exercise period for any 2018 Outstanding Option be extended to later than the final exercise date (final expiration date) applicable to such option)(the “ Post-Termination Exercise Period Extension ”). Executive understands that to the extent that any options subject to this extended exercise period were intended to be incentive share options for U.S. federal income tax purposes, such options shall cease to be treated for tax purposes as incentive share options as of the Additional Release Effective Date. In addition, provided that the Executive continues to serve on the Board or provide services to the Company under the Consulting Agreement (together, the “ Post-Separation Services ”) on the effective grant date of that Restricted Share Unit Agreement (Performance Based) (the “ PRSU ”) previously approved by the

Board, such PRSU shall be granted to Executive on the terms and subject to the conditions set forth in the applicable PRSU agreement on the effective grant date, provided, however, that if the applicable Performance Condition set forth in the PRSU agreement is achieved while the Executive is providing any Post-Separation Services and Executive ceases to provide all Post-Separation Services prior to the first anniversary of the achievement of the Performance Condition, the remaining unvested portion of the PRSU shall vest and the ordinary shares subject to such PRSU shall be delivered to Executive, subject to Section 19 hereof, following his cessation of Post-Separation Services (the Accelerated Options, Post-Termination Exercise Period Extension and the PRSU terms as modified herein, collectively the “ Equity Benefits ”).

Except as provided in Section 1(d) and the Consulting Agreement, and other than the Severance Benefits and the Equity Benefits, Executive will not be eligible for, nor shall he have a right to receive, any payments or benefits from the Company or the Parent following the Separation Date, other than reimbursement for any outstanding business expenses in accordance with Company policy.

3. Release of Claims — In exchange for the consideration set forth in this Agreement, which Executive acknowledges he would not otherwise be entitled to receive, Executive hereby fully, forever, irrevocably and unconditionally releases, remises and discharges the Company, its affiliates (including, without limitation, the Parent), subsidiaries, parent companies, predecessors, and successors, and all of its and their respective past and present officers, directors, stockholders, investors, partners, members, managers, employees, agents, representatives, plan administrators, attorneys, insurers and fiduciaries (each in their individual and corporate capacities) (collectively, the “ Released Parties ”) from any and all claims, complaints, demands, actions, causes of action, suits, rights, debts, sums of money, costs, accounts, reckonings, covenants, contracts, agreements, promises, doings, omissions, damages, executions, obligations, liabilities, and expenses (including attorneys’ fees and costs), of every kind and nature that Executive ever had or now has against any or all of the Released Parties, whether known or unknown, including, but not limited to, any and all claims arising out of or relating to Executive’s employment with and/or separation from the Company, including, but not limited to, all claims under Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq. , the Americans With Disabilities Act of 1990, 42 U.S.C. § 12101 et seq. , the Genetic Information Nondiscrimination Act of 2008, 42 U.S.C. § 2000ff et seq. , the Family and Medical Leave Act, 29 U.S.C. § 2601 et seq. , the Worker Adjustment and Retraining Notification Act (“ WARN ”), 29 U.S.C. § 2101 et seq. , the Rehabilitation Act of 1973, 29 U.S.C. § 701 et seq. , Executive Order 11246, Executive Order 11141, the Fair Credit Reporting Act, 15 U.S.C. § 1681 et seq. , and the Employee Retirement Income Security Act of 1974 (“ ERISA ”), 29 U.S.C. § 1001 et seq. , all as amended; all claims arising out of the Pennsylvania Human Relations Act, 43 Pa. Stat. § 951 et seq. , the Pennsylvania Equal Pay Law, 43 Pa. Stat. § 336.1 et seq. , and the Pennsylvania Whistleblower Law, 43 Pa. Stat. § 1421 et seq. , all as amended; all common law claims including, but not limited to, actions in defamation, intentional infliction of emotional distress, misrepresentation, fraud, wrongful discharge, and breach of contract (including, without limitation, all claims arising out of or related to the Employment Agreement); all claims to any non-vested ownership interest in the Company, contractual or otherwise; all

state and federal whistleblower claims to the maximum extent permitted by law; and any claim or damage arising out of Executive’s employment with and/or separation from the Company (including a claim for retaliation) under any common law theory or any federal, state or local statute or ordinance not expressly referenced above ; provided, however, that nothing in this release of claims prevents Executive from filing a charge with, cooperating with, or participating in any investigation or proceeding before, the Equal Employment Opportunity Commission or a state fair employment practices agency (except that Executive acknowledges that he may not recover any monetary benefits in connection with any such charge, investigation, or proceeding, and Executive further waives any rights or claims to any payment, benefit, attorneys’ fees or other remedial relief in connection with any such charge, investigation or proceeding). Further, nothing herein shall prevent Executive from bringing claims to enforce this Agreement, or release (i) any rights Executive may have under the Company’s certificate of incorporation, by-laws, insurance and/or any indemnification agreement between him and the Company (and/or otherwise under law) for indemnification and/or defense as an employee, officer or director of the Company for his service to the Company (recognizing that such indemnification and/or defense is not guaranteed by this Agreement and shall be governed by the instrument or law, if any, providing for such indemnification and/or defense), (ii) any rights Executive may have to vested pension or 401(k) benefits or interests under any ERISA-Covered benefit plan (excluding severance) provided by the Company, or (iii) any rights or claims that cannot be waived by law, including claims for unemployment benefits.

4. Continuing Obligations — Executive acknowledges and reaffirms his obligation, to the extent permitted by law and except as otherwise permitted by Section 8 below, to keep confidential and not to use or disclose any and all non-public information concerning the Company and/or its Affiliates that Executive acquired during the course of his employment with the Company and/or its Affiliates, including, but not limited to, any non-public information concerning the Company’s and/or its Affiliates’ business affairs, business prospects, and financial condition. Executive further acknowledges and reaffirms his obligations set forth in the Proprietary Rights, Non-Disclosure, Developments, Non-Competition and Non-Solicitation Agreement that he previously executed for the benefit of the Company (the “ NDA ”), which remain in full force and effect and which survive his separation from employment with the Company. Further, in consideration of this Agreement and the Consulting Agreement, Executive acknowledges and agrees that the provisions of the NDA with respect to Proprietary Information and Developments are amended hereby, so that all such obligations Executive had and continues to have by virtue of his employment with the Company will be obligations that he now also has by virtue of his consulting relationship with the Company, and the NDA is hereby deemed amended such that all references in the NDA (other than those in Section 3) to “Employee” shall be read as referring also to “Consultant,” and all references therein to “employment” or being “employed” shall be read as referring also to the engagement of the Consultant and the provision of consulting services to the Company (By way of illustration, this means, for example, that Section 2(a) of the NDA, which requires Employee’s disclosure to the Company of inventions made during his employment with the Company, shall also be read to require the Consultant’s disclosure of inventions to the Company during the Consultation Period (as defined in the

Consulting Agreement). For the avoidance of doubt, this also means that the duration of the Non-Competition and Non-Solicitation obligations pursuant to Section 3 of the NDA are not amended but remain in effect for a period of twelve (12) months after the Separation Date.)

5. Non-Disparagement — Executive understands and agrees that, to the extent permitted by law and except as otherwise permitted by Section 8 below, he will not, in public or private, make any false, disparaging, derogatory or defamatory statements to any person or entity, including, but not limited to, any media outlet, industry group, financial institution or current or former employee, board member, consultant, client or customer of the Company, regarding the Company or any of the other Released Parties, or regarding the Company’s business affairs, business prospects, or financial condition; provided, however, that nothing herein shall be construed as preventing Executive from making truthful disclosures in any litigation or arbitration. The Company likewise agrees that it will instruct its officers and directors not to, in public or private, make any false, disparaging, derogatory or defamatory statements to any person or entity, including, but not limited to, any media outlet, industry group, financial institution or current or former employee, board member, consultant, client or customer of the Company, regarding Executive; provided, however, that nothing herein shall be construed as preventing the Company from making truthful disclosures in any litigation or arbitration.

6. Return of Company Property — Executive confirms that he will, upon the date that Executive ceases being a member of the Board, or earlier if requested by the Company, return to the Company all keys, files, records (and copies thereof), equipment (including, but not limited to, computer hardware, software and printers, wireless handheld devices, cellular phones, tablets, etc.), Company identification and any other Company-owned property in his possession or control and that he will leave intact all electronic Company documents, including but not limited to those that he developed or helped to develop during his employment. Executive further confirms that he will, upon the Separation Date or earlier if requested by the Company, cancel all accounts for his benefit, if any, in the Company’s name, including but not limited to, credit cards, telephone charge cards, cellular phone and/or wireless data accounts and computer accounts.

7. Confidentiality — Executive understands and agrees that, to the extent permitted by law and except as otherwise permitted by Section 8 below, the contents of the negotiations and discussions resulting in this Agreement shall be maintained as confidential by Executive and his agents and representatives and shall not be disclosed except as otherwise agreed to in writing by the Company; provided, however, that nothing herein shall be construed as preventing Executive from making truthful disclosures in any litigation or arbitration.

8. Scope of Disclosure Restrictions — Nothing in this Agreement or elsewhere prohibits Executive from communicating with government agencies about possible violations of federal, state, or local laws or otherwise providing information to government agencies, filing a complaint with government agencies, or participating in government agency investigations or proceedings. Executive is not required to notify the Company of any such communications; provided, however, that nothing herein authorizes the disclosure of

information Executive obtained through a communication that was subject to the attorney-client privilege. Further, notwithstanding Executive’s confidentiality and nondisclosure obligations, Executive is hereby advised as follows pursuant to the Defend Trade Secrets Act: “An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (A) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. An individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual (A) files any document containing the trade secret under seal; and (B) does not disclose the trade secret, except pursuant to court order.”

9. Cooperation — Executive agrees that, to the extent permitted by law, he shall cooperate reasonably with the Company in the investigation, defense or prosecution of any claims or actions which already have been brought, are currently pending, or which may be brought in the future against the Company by a third party or by or on behalf of the Company against any third party, whether before a state or federal court, any state or federal government agency, or a mediator or arbitrator. Executive’s reasonable cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with the Company’s counsel, at reasonable times and locations designated by the Company, to investigate or prepare the Company’s claims or defenses, to prepare for trial or discovery or an administrative hearing, mediation, arbitration or other proceeding and to act as a witness when requested by the Company. The Company shall use reasonable efforts to schedule Executive’s cooperation at times convenient to him, and will reimburse him for all reasonable out-of-pocket expenses incurred by him in connection with such cooperation. Executive further agrees that, to the extent permitted by law, he will notify the Company promptly in the event that he is served with a subpoena (other than a subpoena issued by a government agency), or in the event that he is asked to provide a third party (other than a government agency) with information concerning any actual or potential complaint or claim against the Company.

10. Amendment and Waiver — This Agreement shall be binding upon the Parties and may not be modified in any manner, except by an instrument in writing of concurrent or subsequent date signed by duly authorized representatives of the Parties. This Agreement is binding upon and shall inure to the benefit of the Parties and their respective agents, assigns, heirs, executors/administrators/personal representatives, and successors. No delay or omission by the Company in exercising any right under this Agreement shall operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar to or waiver of any right on any other occasion.

11. Validity — Should any provision of this Agreement be declared or be determined by any court of competent jurisdiction to be illegal or invalid, the validity of the remaining parts, terms or provisions shall not be affected thereby and said illegal or invalid part, term or provision shall be deemed not to be a part of this Agreement.

12. Nature of Agreement — The Parties understand and agree that this Agreement is a transition and separation agreement and that nothing herein constitutes an admission of liability or wrongdoing on the part of the Company or Executive.

13. Time for Consideration and Revocation — Executive acknowledges that he was initially presented with this Agreement on July 23, 2018 (the “ Receipt Date ”). Executive understands that this Agreement shall be of no force or effect, and that he shall not be eligible for the consideration described herein, unless he: (i) signs and returns this Agreement no later than July 23, 2018 (the date of such signing and return, the “ Agreement Effective Date ”), and (ii) signs and returns the Additional Release on, but not before, the Separation Date (provided, however, that if the Separation Date is fewer than twenty-one (21) days following the Receipt Date, Executive must sign and return the Additional Release no earlier than the Separation Date and no later than the 22 nd day after the Receipt Date) and does not revoke his acceptance in the subsequent seven (7) day period (the day immediately following expiration of such revocation period, the “ Additional Release Effective Date ”).

14. Acknowledgments — Executive acknowledges that he has been given a reasonable period of time to consider this Agreement, and that he has been given at least twenty-one (21) days to consider the Additional Release, and that the Company is hereby advising him to consult with an attorney of his own choosing prior to signing this Agreement or the Additional Release. Executive further acknowledges and agrees that any changes made to this Agreement or the Additional Release following his initial receipt of this Agreement, whether material or immaterial, shall not re-start or affect in any manner the review period for this Agreement or the twenty-one (21) day consideration period for the Additional Release. Executive understands that he may revoke the Additional Release for a period of seven (7) days after he signs it by notifying the Company in writing, and the Additional Release shall not be effective or enforceable until the expiration of this seven (7) day revocation period. Executive understands and agrees that by entering into the Additional Release he will be waiving any and all rights or claims he might have under the Age Discrimination in Employment Act, as amended by the Older Workers Benefit Protection Act, and that he has received consideration beyond that to which he was previously entitled.

15. Voluntary Assent — Executive affirms that no other promises or agreements of any kind have been made to or with Executive by any person or entity whatsoever to cause him to sign this Agreement, and that he fully understands the meaning and intent of this Agreement. Executive further states and represents that he has carefully read this Agreement, understands the contents herein, freely and voluntarily assents to all of the terms and conditions hereof, and signs his name of his own free act.

16. Applicable Law — This Agreement shall be interpreted and construed by the laws of the Commonwealth of Pennsylvania, without regard to conflict of laws provisions. Executive hereby irrevocably submits to and acknowledges and recognizes the jurisdiction of the courts of the Commonwealth of Pennsylvania, or if appropriate, a federal court located in the Commonwealth of Pennsylvania (which courts, for purposes of this Agreement, are the only courts of competent jurisdiction), over any suit, action or

other proceeding arising out of, under or in connection with this Agreement or the subject matter hereof. The Company and Executive each hereby irrevocably waives any right to a trial by jury in any action, suit or other legal proceeding arising under or relating to this Agreement or Executive’s employment with or separation from the Company.

17. Entire Agreement — This Agreement contains and constitutes the entire understanding and agreement between the Parties hereto with respect to Executive’s transition and separation from the Company, severance benefits and the settlement of claims against the Company, and cancels all previous oral and written negotiations, agreements, commitments and writings in connection therewith; provided, however, that nothing in this Section shall modify, cancel or supersede Executive’s obligations set forth in Section 4 above.

18. Tax Acknowledgement — In connection with the Severance Benefits and Equity Benefits provided to Executive pursuant to this Agreement, the Company shall withhold and remit to the tax authorities the amounts required under applicable law, and Executive shall be responsible for all applicable taxes owed by him with respect to such Severance Benefits under applicable law. Executive acknowledges that he is not relying upon the advice or representation of the Company with respect to the tax treatment of any of the Severance Benefits or Equity Benefit set forth in this Agreement.

19. Section 409A - This Agreement, and all payments hereunder, are intended to be exempt from, or if not so exempt, to comply with the requirements of, Section 409A of the Internal Revenue Code of 1986, as amended, and the guidance issued thereunder (“ Section 409A ”), and this Agreement shall be interpreted and administered accordingly. Notwithstanding anything to the contrary in this Agreement, if at the time of Executive’s termination of employment or otherwise when any Severance Benefit or Equity Benefit is payable hereunder, he is a “specified employee” as defined under Section 409A, any and all amounts payable hereunder on account of such termination of employment that would (but for this provision) be payable within six (6) months following the Separation Date, shall instead be paid on the next business day following the expiration of such six (6) month period or, if earlier, upon Executive’s death; except to the extent of amounts that do not constitute a deferral of compensation within the meaning of Treasury regulation Section 1.409A — 1(b) or other amounts or benefits that are exempt from or otherwise not subject to the requirements of Section 409A. For purposes of this Agreement, whether or not a termination of employment has occurred shall be determined consistently with Section 409A. In addition, each payment made pursuant to the Agreement shall be treated as a separate payment and the right to a series of installment payments hereunder is to be treated as a right to a series of separate payments. Neither the Company, nor the Parent, nor any of their agents or affiliates shall have any liability to Executive should the benefits and payments hereunder that are intended to be exempt from or compliant with Section 409A, not be so exempt or compliant.

20. Counterparts — This Agreement may be executed in several counterparts, each of which shall be deemed to be an original, but all of which together will constitute one and the same agreement. Facsimile and PDF signatures shall be deemed to be of equal force and effect as originals.

IN WITNESS WHEREOF, the Parties have set their hands and seals to this Agreement as of the date(s) written below.

Nabriva Therapeutics US, Inc.

/s/ Gary Sender	Date:	July 23, 2018
By: Gary Sender

I hereby agree to the terms and conditions set forth above. I understand that the Severance Benefits and Equity Benefits are conditioned upon my timely execution, return and non-revocation of the Additional Release.

Colin Broom

/s/ Colin Broom

Date:

July 23, 2018

ATTACHMENT A

CONSULTING AGREEMENT

This Consulting Agreement (this “ Agreement ”) is entered into as of July 24, 2018 (the “ Effective Date ”) by and between Nabriva Therapeutics US, Inc. (the “ Company ”), and Colin Broom (the “ Consultant ”).

WHEREAS , the Consultant has certain knowledge and expertise regarding the Company as a result of having served as its Chief Executive Officer; and

WHEREAS , the Company desires to have the benefit of the Consultant’s knowledge and experience, and the Consultant desires to provide consulting services to the Company, all as hereinafter provided in this Agreement.

NOW, THEREFORE , in consideration of the promises and mutual agreements hereinafter set forth, the sufficiency of which are hereby acknowledged, the Company and the Consultant hereby agree as follows:

Section 1. Services .

(a) Services; Performance . The Consultant shall render to the Company the consulting services described in Exhibit A attached to this Agreement and any additional consulting services as mutually agreed to by the Consultant and the Company from time to time in writing (collectively, the “ Services ”); provided, however, that the parties intend that the Consultant shall provide the Services, on average, no more than one day per week, that the Services will not exceed 20% of the average amount of time that Consultant devoted to his employment and other service with the Company during the three-year period immediately preceding the Effective Date, and that, accordingly, Consultant’s termination of employment with the Company constituted a “separate from service” within the meaning of Section 409A of the Internal Revenue Code of 1986, as amended. The Consultant shall perform such Services in a professional manner and consistent with the highest industry standards at such reasonable times as the Company may from time to time request. The Consultant shall comply with all rules, procedures and standards promulgated from time to time by the Company with respect to the Consultant’s access to and use of the Company’s property, information, equipment and facilities in the course of the Consultant’s provision of Services hereunder.

(b) Non-Exclusive . The parties agree that, at all times during the term of this Agreement, (i) the Company shall be free to obtain consulting and advisory services from any third party, and (ii) the Consultant shall be free to provide consulting and advisory services to any third party, so long as the provision of such services by the Consultant does not conflict with the Consultant’s (x) provision of Services to the Company as described in Section 1(a), or (y) continuing obligations to the Company as detailed in the Transition, Separation and Release of Claims Agreement entered into by the parties concurrently with this Agreement and to which this Consulting Agreement is attached as Attachment A (the “ Separation Agreement ”), including the Consultant’s ongoing obligations under the NDA referenced therein and amended thereby.

Section 2. Compensation and Reimbursement .

(a) Compensation . As consideration for the performance of Services by the Consultant hereunder, the Company shall compensate the Consultant at such hourly rate to be mutually agreed upon by the Company and the Consultant.

(b) Expense Reimbursement . The Company shall reimburse the Consultant for all reasonable out-of-pocket expenses incurred by the Consultant in connection with the performance of the Services under this Agreement, so long as they are approved in writing in advance by the Company.

(c) Itemized Statements . At the end of any month that the Consultant performs Services or incurs expenses, the Consultant shall submit to the Company an itemized statement of the Services performed, including the number of hours worked and the project to which the Services relate, and the expenses incurred, including appropriate and reasonable documentation. The Company shall pay the Consultant the amount set forth on such itemized statement within forty-five (45) days after receipt, provided that if there is any disagreement with respect to the itemized statement, the Company and the Consultant shall work together in good faith to resolve such disagreement.

(d) No Employee Benefits . The Consultant’s relationship with the Company will be that of an independent contractor, and the Consultant shall not, in connection with this relationship, be entitled to any benefits, coverages or privileges, including without limitation social security, unemployment, medical or pension payments, made available to employees of the Company.

Section 3. Term and Termination .

(a) Consultation Period . Subject to the terms and conditions hereinafter set forth, the term of this Agreement shall expire upon termination or expiration of the term of the Consultant’s consulting arrangement with the Company hereunder (the “ Consultation Period ”), which Consultation Period shall commence on the Effective Date and shall continue until January 31, 2020 unless earlier terminated as set forth below. Notwithstanding the foregoing, however, the Consultation Period may be extended for an additional period(s) upon the mutual written agreement of both parties. The terms and conditions of this Agreement shall continue to govern any Services that continue past expiration or termination of this Agreement. This Agreement may be terminated in the following manner: (i) by the Company at any time immediately upon written notice if the Consultant has materially breached this Agreement or the Separation Agreement (or if the Consultant fails to sign, or revokes, the Additional Release attached as Attachment B to the Separation Agreement); (ii) by the Consultant at any time immediately upon written notice if the Company has materially breached this Agreement or the Separation Agreement; (iii) by either party at any time, for any reason or no reason, upon not less than fifteen (15) days prior written notice to the other party; (iv) at any time upon the mutual written consent of the parties hereto; or (v) automatically upon the death, physical incapacitation or mental incompetence of the Consultant.

(b) Effects of Termination . In the event of any termination under this Section 3, the Consultant shall be entitled only to payment for Services performed and expenses incurred in accordance with Section 2(a) and 2(b) prior to the effective date of such termination.

Section 4. Independent Contractor . The Consultant is not as of the Effective Date, nor shall the Consultant be deemed to be at any time during the term of this Agreement, an employee of the Company. The Consultant’s status and relationship with the Company shall be that of an independent contractor and consultant. The Consultant is not authorized to assume or create any obligation or responsibility, express or implied, on behalf of, or in the name of, the Company or to bind the Company in any manner. Nothing herein shall create, expressly or by implication, a partnership, joint venture or other association between the parties. The Consultant shall be solely responsible for payment of all charges and taxes arising from the payments to be made to the Consultant under this Agreement and the Consultant agrees that the Company shall have no obligation or liability with respect to such charges and/or taxes.

Section 5. Notice . Any notice required or desired to be given shall be governed solely by this paragraph. Notice shall be deemed given only upon (a) mailing of any letter or instrument by overnight delivery with a reputable carrier or by registered mail, return receipt requested, postage prepaid by the sender, or (b) personal delivery.

If to the Consultant :	If to the Company :
Colin Broom	Nabriva Therapeutics US, Inc.
At address last on file with the Company	1000 Continental Drive, Suite 600
	King of Prussia, PA 19406 USA
	Attention: General Counsel

From time to time, either party may, by written notice to the other in accordance with this Section 5, designate another address that shall thereupon become the effective address of such party for the purpose of this Section 5.

Section 6. Miscellaneous . This Agreement, together with Exhibit A hereto, constitutes the entire understanding of the parties hereto with respect to the matters contained herein and supersedes all proposals and agreements, written or oral, and all other communications between the parties relating to the subject matter of this Agreement. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Pennsylvania without regard to its conflict of laws rules. The headings contained in this Agreement are for the convenience of the parties and are not to be construed as a substantive provision hereof. This Agreement may not be modified or amended except in writing signed or executed by the Consultant and the Company. In the event any provision of this Agreement is held to be unenforceable or invalid, such unenforceability or invalidity shall not affect any other provisions of this Agreement and such other provisions shall remain in full force and effect. If any provision of this Agreement is held to be excessively broad, it shall be reformed and construed by limiting and reducing it so as to be enforceable to the maximum extent permitted by law. This Agreement shall be binding upon, and inure to the benefit of, both parties hereto and their respective successors and assigns, including any corporation with or into which the Company may be merged or which may succeed to its assets or business; provided, however, that the responsibility for actual performance of the Services is personal to the Consultant and may not be assigned or delegated by the Consultant to any other person or entity. This Agreement may be executed in counterparts and by facsimile, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed as of the date first written above.

CONSULTANT		COMPANY


/s/ Colin Broom		/s/ Gary Sender
Signature		Signature

		Gary Sender
Colin Broom		Printed Name

		Chief Financial Officer
		Title

Exhibit A to Consulting Agreement

Description of Services

The Consultant shall use his knowledge and expertise regarding the Company to provide, upon request by the Board of Directors of Nabriva Therapeutics plc, consulting and advisory services relating to the preparation and submission of a new drug application for the Company’s lefamulin product candidate to the United States Food and Drug Administration (the “ FDA ”) (including any engagement with the FDA in respect thereof).

ATTACHMENT B

ADDITIONAL RELEASE OF CLAIMS

1. Release . In exchange for the Severance Benefits and Equity Benefits described in the Separation and Release of Claims Agreement (the “ Agreement ”) to which this Additional Release of Claims (the “ Additional Release ”) is attached as Attachment B, which Colin Broom (“ Executive ”) acknowledges he would not otherwise be entitled to receive, Executive hereby fully, forever, irrevocably and unconditionally releases, remises and discharges Nabriva Therapeutics U.S. Inc. (the “ Company ”), its affiliates (including, without limitation, Nabriva Therapeutics plc (the “ Parent ”)), subsidiaries, parent companies, predecessors, and successors, and all of its and their respective past and present officers, directors, stockholders, investors, partners, members, managers, employees, agents, representatives, plan administrators, attorneys, insurers and fiduciaries (each in their individual and corporate capacities) (collectively, the “ Released Parties ”) from any and all claims, complaints, demands, actions, causes of action, suits, rights, debts, sums of money, costs, accounts, reckonings, covenants, contracts, agreements, promises, doings, omissions, damages, executions, obligations, liabilities, and expenses (including attorneys’ fees and costs), of every kind and nature that Executive ever had or now has against any or all of the Released Parties, whether known or unknown, including, but not limited to, any and all claims arising out of or relating to Executive’s employment with and/or separation from the Company, including, but not limited to, all claims under Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq. , the Americans With Disabilities Act of 1990, 42 U.S.C. § 12101 et seq. , the Age Discrimination in Employment Act, 29 U.S.C. § 621 et seq. , the Genetic Information Nondiscrimination Act of 2008, 42 U.S.C. § 2000ff et seq. , the Family and Medical Leave Act, 29 U.S.C. § 2601 et seq. , the Worker Adjustment and Retraining Notification Act (“ WARN ”), 29 U.S.C. § 2101 et seq. , the Rehabilitation Act of 1973, 29 U.S.C. § 701 et seq. , Executive Order 11246, Executive Order 11141, the Fair Credit Reporting Act, 15 U.S.C. § 1681 et seq. , and the Employee Retirement Income Security Act of 1974 (“ ERISA ”), 29 U.S.C. § 1001 et seq. , all as amended; all claims arising out of the Pennsylvania Human Relations Act, 43 Pa. Stat. § 951 et seq. , the Pennsylvania Equal Pay Law, 43 Pa. Stat. § 336.1 et seq. , and the Pennsylvania Whistleblower Law, 43 Pa. Stat. § 1421 et seq. , all as amended; all common law claims including, but not limited to, actions in defamation, intentional infliction of emotional distress, misrepresentation, fraud, wrongful discharge, and breach of contract (including, without limitation, all claims arising out of or related to the Employment Agreement); all claims to any non-vested ownership interest in the Company, contractual or otherwise; all state and federal whistleblower claims to the maximum extent permitted by law; and any claim or damage arising out of Executive’s employment with and/or separation from the Company (including a claim for retaliation) under any common law theory or any federal, state or local statute or ordinance not expressly referenced above; provided, however, that nothing in this release of claims prevents Executive from filing a charge with, cooperating with, or participating in any investigation or proceeding before, the Equal

Employment Opportunity Commission or a state fair employment practices agency (except that Executive acknowledges that he may not recover any monetary benefits in connection with any such charge, investigation, or proceeding, and Executive further waives any rights or claims to any payment, benefit, attorneys’ fees or other remedial relief in connection with any such charge, investigation or proceeding). Further, nothing herein shall prevent Executive from bringing claims to enforce this Agreement, or release (i) any rights Executive may have under the Company’s certificate of incorporation, by-laws, insurance and/or any indemnification agreement between him and the Company (and/or otherwise under law) for indemnification and/or defense as an employee, officer or director of the Company for his service to the Company (recognizing that such indemnification and/or defense is not guaranteed by this Agreement and shall be governed by the instrument or law, if any, providing for such indemnification and/or defense), (ii) any rights Executive may have to vested pension or 401(K) benefits or interests under any ERISA-Covered benefit plan (excluding severance) provided by the Company, or (iii) any rights or claims that cannot be waived by law, including claims for unemployment benefits.

2. Final Compensation . Executive acknowledges that he has been reimbursed by the Company for all business expenses incurred in conjunction with the performance of his employment and that no other reimbursements are owed to him. Executive acknowledges that he has received all compensation due to him from the Company, including, but not limited to, all wages, bonuses and accrued, unused vacation time, and that he is not eligible or entitled to receive any additional payments or consideration from the Company beyond that provided for in Section 2 of the Agreement.

3. Return of Company Property . Executive confirms that he will, upon the date that Executive ceases being a member of the Board, or earlier if requested by the Company, return to the Company all keys, files, records (and copies thereof), equipment (including, but not limited to, computer hardware, software and printers, wireless handheld devices, cellular phones, tablets, etc.), Company identification and any other Company-owned property in his possession or control and that he will leave intact all electronic Company documents, including but not limited to those that he developed or helped to develop during his employment. Executive further confirms that has canceled all accounts for his benefit, if any, in the Company’s name, including but not limited to, credit cards, telephone charge cards, cellular phone and/or wireless data accounts and computer accounts.

4. Acknowledgments . Executive acknowledges that he has been given at least twenty-one (21) days to consider this Additional Release, and that the Company has advised him in writing to consult with an attorney of his own choosing prior to signing this Additional Release. Executive understands that he may revoke this Additional Release for a period of seven (7) days after he signs it by notifying the Company in writing, and the Additional Release shall not be effective or enforceable until the expiration of this seven (7) day revocation period. Executive understands and agrees that by entering into this Additional Release, he is waiving any and all rights or claims he might have under the Age Discrimination in Employment Act, as amended by the Older Workers Benefit

Protection Act, and that he has received consideration beyond that to which he was previously entitled.

5. Voluntary Assent . Executive affirms that no other promises or agreements of any kind have been made to or with him by any person or entity whatsoever to cause him to sign this Additional Release, and that he fully understands the meaning and intent of this Additional Release. Executive states and represents that he has had an opportunity to fully discuss and review the terms of this Additional Release with an attorney. Executive further states and represents that he has carefully read this Additional Release, understands the contents herein, freely and voluntarily assents to all of the terms and conditions hereof, and signs his name of his own free act.

I hereby provide this Additional Release as of the date below and acknowledge that the execution of this Additional Release is in further consideration of the Severance Benefits and Equity Benefits, to which I acknowledge I would not be entitled if I did not enter into this Additional Release . I intend that this Additional Release become a binding agreement between the Company and me if I do not revoke my acceptance in seven (7) days.


Colin Broom		Date

Exhibit 10.2

EMPLOYMENT AGREEMENT

THIS EMPLOYMENT AGREEMENT (the “Agreement”), is made by and between Nabriva Therapeutics US, Inc. (the “Company”), and Theodore R. Schroeder (the “Executive”) (together, the “Parties”). The Parties agree that this Agreement is contingent on the closing of the transaction (the “Closing”) contemplated by the Agreement and Plan of Merger dated as of July 23, 2018 (the “Purchase Agreement”) by and among Nabriva Therapeutics plc, a public limited company under the Laws of Ireland (“Parent”), Zuperbug Merger Sub I, Inc., Zuperbug Merger Sub II, Inc., Zavante Therapeutics, Inc. and Cam Gallagher, and shall become effective as of the Closing (the “Effective Date”). In the event the Closing does not occur this Agreement shall have no force and effect and shall be null and void.

RECITALS

WHEREAS, the Company desires to employ the Executive as its President and Chief Executive Officer and as Chief Executive Officer of its group of companies; and

WHEREAS, the Executive has agreed to accept such employment on the terms and conditions set forth in this Agreement;

NOW, THEREFORE, in consideration of the foregoing and of the respective covenants and agreements of the Parties herein contained, the Parties hereto agree as follows:

1. Agreement . This Agreement shall be effective as of the Effective Date. Following the Effective Date, the Executive shall continue to be an employee of the Company until such employment relationship is terminated in accordance with Section 7 hereof (the “Term of Employment”).

2. Position . During the Term of Employment, the Executive shall serve as the President and Chief Executive Officer of the Company and Chief Executive Officer of the Parent, working out of the Company’s office in San Diego, California, and travelling as reasonably required by the Executive’s job duties. Effective as of the Effective Date, the Executive shall be appointed to the board of directors of the Company (and such other subsidiaries of the Parent as the Board may designate). Effective as of the later of the Effective Date and immediately following the 2018 Annual General Meeting of Shareholders of Parent, the Executive shall also be appointed to the board of directors of the Parent. The Executive shall not receive any additional compensation for serving as a director of the Company, the Parent or any other subsidiary of the Parent. The Executive must resign from any office held in the Company, the Parent and/or any other subsidiary of the Parent if requested in writing to do so by the Company (or, with respect to the Executive’s position as a member of the Board, by the Board) on the termination of his employment. If the Executive does not do so on being requested to do so, the Company is hereby irrevocably authorized to appoint a person in his name to sign and deliver any required letter(s) of resignation to the Company and/or the Parent, as applicable.

3. Scope of Employment . During the Term of Employment, the Executive shall be responsible for the performance of those duties consistent with the Executive’s position as President and Chief Executive Officer of the Company and Chief Executive Officer of the Parent. The Executive shall report and be accountable to the board of directors of the Company and the board of directors of the Parent (the board of directors

of the Parent, hereinafter, the “Board”) and shall perform and discharge faithfully, diligently, and to the best of the Executive’s ability, the Executive’s duties and responsibilities hereunder. The Executive shall devote substantially all of the Executive’s business time, loyalty, attention and efforts to the business and affairs of the Company, the Parent, and their affiliates. Membership on boards of directors of any companies (other than those companies affiliated with the Company and the Parent) will be permitted only with the express approval of the Board; provided, however, that the Company acknowledges that the Executive serves as a member of the board of directors of each of Cidara Therapeutics, Inc., Otonomy, Inc. and Collegium Pharmaceutical, Inc. as of the Effective Date and agrees that his continued service on such boards is permitted and shall not constitute a violation of this Section 3. In addition, the Executive may engage in community and charitable activities or participate in industry associations and serve on the boards of up to three (3) community, charitable or industry organizations, without the approval of the Board, provided such activities do not create a conflict of interest or otherwise interfere with the Executive’s performance of the Executive’s duties hereunder. The Executive agrees to abide by the rules, regulations, instructions, personnel practices and policies of the Company and the Parent and any changes therein that may be adopted from time to time by the Company and/or the Parent.

4. Compensation . As full compensation for all services rendered by the Executive to the Company and the Parent and any affiliate thereof, during the Term of Employment, the Company will provide to the Executive the following:

(a) Base Salary . The Executive shall receive a base salary at the annualized rate of $530,000 (the “Base Salary”), paid in equal bi-monthly installments in accordance with the Company’s regularly established payroll procedure. Such Base Salary shall be reviewed by the compensation committee of the Board and/or the full Board in the first quarter of each fiscal year; any adjustment to the Executive’s Base Salary shall be retroactively effective as of the first day of such fiscal year.

(b) Annual Discretionary Bonus . Following the end of each fiscal year and subject to the approval of the Board, the Executive may be eligible to receive a discretionary annual retention and performance bonus of 50% of the Executive’s then current Base Salary (the “Target Bonus”), based on the Executive’s performance and the performance of the Company and Parent during the applicable fiscal year, as determined by the Board in its sole discretion. All annual bonuses, if any, will be payable no later than March 15 of the year following the year in which they are earned. The Executive must be employed on the date of payment in order to be eligible for any annual bonus, except as specifically set forth below. Any bonus determined by the Board to be payable to the Executive with respect to 2018 shall be pro-rated based on the number of days in 2018 during which the Executive is employed by the Company.

(c) Equity Awards . Subject to approval by the compensation committee of the Board or a majority of the Parent’s Independent Directors as defined in Nasdaq Listing Rule 5605(a)(2), and as a material inducement to the Executive entering into employment with the Company and serving as President and Chief Executive Officer of the Company and Chief Executive Officer of the Parent, on or about the Effective Date, the Executive shall be granted:

(i) an option (the “Option”) to purchase 850,000 ordinary shares, nominal value $0.001 per share, of Parent (each an “Ordinary Share”), such Option to (1) have an exercise price per share equal to the closing price per share of the Ordinary Shares on the Nasdaq Global Select Market on the date of grant, (2) vest and become exercisable, subject to the Executive’s continued service on each applicable vesting date, at a rate of 25% of the total shares underlying the Option on the first anniversary of the Effective Date and, following that, as to an additional 2.0833% of the total shares underlying the grant on a monthly basis in arrears, (3) be a nonqualified share option and (4) be subject to the terms and conditions of a nonqualified share option agreement between the Executive and the Parent; and

(ii) 150,000 performance-based restricted share units (the “PRSUs” and, together with the Option, the “Equity Awards”), which PRSUs shall (1) entitle the Executive to receive one Ordinary Share for each PRSU that vests, (2) be subject to vesting such that all of the PRSUs shall be earned upon Board certification of the receipt of U.S. Food and Drug Administration (“FDA”) approval of a new drug application for each of (x) the Company’s lefamulin product candidate and (y) the Company Milestone Product (as such term is defined in the Purchase Agreement), provided that both such FDA approvals are received by January 31, 2020 and provided further that 50% of the PRSUs so earned shall vest upon Board certification of satisfaction of the relevant performance metric and 50% of the PRSUs so earned shall vest on the first anniversary of such certification, in each case subject to the Executive’s continued employment on the applicable vesting date, and (3) be subject to the terms and conditions of a performance-based restricted share unit agreement between the Executive and the Parent.

The Equity Awards shall be awarded outside of the Parent’s and the Company’s equity incentive plans as “inducement grants” within the meaning of Nasdaq Listing Rule 5635(c)(4). The Executive’s rights in, and eligibility for, future equity awards will be determined by the Board or the compensation committee of the Board in its discretion.

(d) Vacation . The Executive shall be eligible for paid vacation in accordance with Company policy for executives; provided that the Executive shall be eligible for no less than 20 days of paid vacation for each full calendar year the Executive is employed by the Company.

(e) Benefits . The Executive may participate in any and all benefit programs that the Company establishes and makes available to its senior executive employees from time to time, provided that the Executive is eligible under (and subject to all provisions of) the plan documents governing those programs. Benefits are subject to change at any time in the Company’s sole discretion.

(f) Withholdings . All compensation payable to the Executive shall be subject to applicable taxes and withholdings.

5. Expenses . The Executive shall be entitled to reimbursement by the Company for all reasonable business and travel expenses incurred by the Executive on the Company’s behalf during the course of the Executive’s employment in accordance with applicable Company policy in effect from time to time, upon the presentation by the Executive of documentation itemizing such expenditures and attaching all supporting vouchers and receipts. Reimbursement will be

made no later than 30 calendar days after the expense is substantiated (which must occur within 30 calendar days after the expense is incurred). The expenses eligible for reimbursement under this provision may not affect the amount of such expenses eligible for reimbursement in any other taxable year, and the right to reimbursement is not subject to liquidation or exchange for another benefit.

6. Restrictive Covenants Agreement . As a condition to the Executive’s employment, the Executive will be required to execute the enclosed Proprietary Rights, Non-Disclosure, Developments and Non-Solicitation Agreement.

7. Employment Termination . This Agreement and the employment of the Executive shall terminate upon the occurrence of any of the following:

(a) Upon the death or “Disability” of the Executive. As used in this Agreement, the term “Disability” shall mean a physical or mental illness or disability that prevents the Executive from performing the duties of the Executive’s position for a period of more than any three consecutive months or for periods aggregating more than twenty-six weeks. The Company shall determine in good faith and in its sole discretion whether the Executive is unable to perform the services provided for herein.

(b) At the election of the Company, with or without “Cause” (as defined below), immediately upon written notice by the Company to the Executive. As used in this Agreement, “Cause” shall mean a finding by the board of directors of the Company acting on the direction of the Board that the Executive:

(i) failed to perform (other than by reason of physical or mental illness or disability for a period of less than three consecutive months or in aggregate less than twenty-six weeks) the Executive’s assigned duties diligently or effectively or was negligent in the performance of these duties;

(ii) materially breached this Agreement;

(iii) materially breached the Executive’s Proprietary Rights, Non-Disclosure, Developments and Non-Solicitation Agreement, or any similar agreement between the Executive and the Company or the Parent;

(iv) engaged in willful misconduct, fraud, or embezzlement;

(v) engaged in any conduct that is materially harmful to the business, interests or reputation of the Company and/or the Parent, except if the Executive had a reasonable and good faith belief that such conduct was in the best interest of the Company and/or the Parent; or

(vi) was convicted of, or pleaded guilty or nolo contendere to, a crime involving moral turpitude or any felony.

To the extent any of the above grounds, other than the grounds set forth in Section 7(b)(iv) and 7(b)(vi), is capable of being cured, the Company shall provide Executive with written notice of the ground, and thirty (30) days within which to cure such ground.

(c) At the election of the Executive, with or without “Good Reason” (as defined below), immediately upon written notice by the Executive to the Company (subject, if it is with Good Reason, to the timing provisions set forth in the definition of Good Reason). As used in this Agreement, “Good Reason” shall mean:

(i) the Company’s failure to pay or provide in a timely manner any material amounts owed to Executive in accordance with this Agreement;

(ii) a material diminution in the nature or scope of Executive’s duties, responsibilities, or authority;

(iii) the Company’s requiring Executive to relocate Executive’s primary office more than fifty (50) miles from San Diego, California (other than to a location that reduces the Executive’s daily commuting distance); or

(iv) any material breach of this Agreement by the Company not otherwise covered by this paragraph;

provided, however, that in each case, the Company shall have a period of not less than thirty (30) days to cure any act constituting Good Reason following the Executive’s delivery to the Company of written notice within sixty (60) days of the action or omission constituting Good Reason. Any resignation by the Executive for Good Reason shall occur within six (6) months following the expiration of such cure period.

8. Effect of Termination .

(a) All Terminations Other Than by the Company Without Cause or by the Executive With Good Reason . If the Executive’s employment is terminated under any circumstances other than a Qualifying Termination (as defined below) (including a voluntary termination by the Executive without Good Reason pursuant to Section 7(c), a termination by the Company for Cause pursuant to Section 7(b) or due to the Executive’s death or Disability pursuant to Section 7(a)), the Company’s obligations under this Agreement shall immediately cease and the Executive shall only be entitled to receive (i) the Base Salary that has accrued and to which the Executive is entitled as of the effective date of such termination and, to the extent consistent with general Company policy, accrued but unused paid time off through and including the effective date of such termination, to be paid in accordance with the Company’s established payroll procedure and applicable law but no later than the next regularly scheduled pay period, (ii) unreimbursed business expenses for which expenses the Executive has timely submitted appropriate documentation in accordance with Section 5 hereof, and (iii) any amounts or benefits to which the Executive is then entitled under the terms of the benefit plans then-sponsored by the Company in accordance with their terms (and not accelerated to the extent acceleration does not satisfy Section 409A of the Internal Revenue Code of 1986, as amended, (the “Code”) (the payments described in this sentence, the “Accrued Obligations”). The Executive shall not be entitled to any other compensation or consideration that the Executive may have received had the

Executive’s Term of Employment not ceased, except that if the Executive’s employment terminated because of his death or Disability, he or his estate, as the case may be, shall, subject to Section 8(d) hereof, be paid on the later of the Payment Date and the date on which annual bonuses are paid to all other employees, any earned but unpaid annual bonus from any previously completed calendar year notwithstanding the requirement that the individual be employed on the payment date of such annual bonus (such payment, the “Earned but Unpaid Bonus”). For the avoidance of doubt, the acceleration of vesting of any outstanding equity award held by the Executive at the time of a termination of his employment (except with respect to the vesting acceleration to which the Executive shall be entitled in the event of a Qualifying Termination as described in Sections 8(b) and 8(c) below) shall be at the discretion of the Board in accordance with the terms of the applicable equity incentive plan of the Parent or the Company, as the case may be.

(b) Termination by the Company Without Cause or by the Executive With Good Reason Prior to or More Than Twelve Months Following a Change in Control. If the Executive’s employment is terminated by the Company without Cause pursuant to Section 7(b) or by the Executive with Good Reason pursuant to Section 7(c) (in either case, a “Qualifying Termination”) prior to or more than twelve (12) months following a Change in Control (as defined below), the Executive shall be entitled to the Accrued Obligations. In addition, and subject to the conditions of Section 8(d), the Company shall: (i) continue to pay to the Executive, in accordance with the Company’s regularly established payroll procedure, the Executive’s Base Salary for a period of eighteen (18) months; (ii) for a period of eighteen (18) months following the date of the Executive’s termination of employment (or, if earlier, the date on which the applicable continuation period under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”) expires)(such period, the “COBRA Coverage Period”), provided the Executive is eligible for and timely elects to continue receiving group medical insurance pursuant to COBRA, continue to pay the Company’s share of the premium the Executive and/or his eligible dependents are required to pay for continuation coverage pursuant to COBRA based on the cost sharing levels in effect on the date of the Executive’s termination of employment, unless the Company’s provision of such COBRA payments will violate the nondiscrimination requirements of applicable law, in which case, instead of providing the benefits as set forth above, the Company shall instead pay to the Executive the foregoing monthly amount as a taxable monthly payment for the COBRA Coverage Period (or any remaining portion thereof), unless the Company determines that such payments would not comply with applicable law in a manner that causes the Company to incur additional taxes, penalties, fines or charges as a result of such payments (other than employer-side employment taxes payable on such payments); (iii) pay the Executive any earned but unpaid annual bonus from a previously completed calendar year on the later of the Payment Date and the date on which annual bonuses are paid to all other employees, notwithstanding the requirement that the individual be employed on the payment date of such annual bonus; (iv) pay the Executive a prorated annual bonus for the year in which the Qualifying Termination occurs, calculated by multiplying 100% of the Target Bonus by a fraction, the numerator of which is equal to the number of days in the calendar year during which Executive was employed and the denominator of which equals 365 (the “Pro-Rated Bonus Payment”), which Pro-Rated Bonus Payment shall be paid in a single lump-sum on the Payment Date; and (v) (i) such portion of the Executive’s equity awards that vest based solely on his continued provision of services to the Company, the Parent or any of their affiliates (and including, for the avoidance of doubt, any

performance-based awards that are subject to time-based vesting following the achievement of the applicable performance metric provided that, at the time of his termination of employment, the applicable performance metric has been achieved) as would have vested during the twelve (12) month period following the date of the Executive’s termination of employment had the Executive remained employed by the Company through such date shall vest and become fully exercisable or non-forfeitable effective as of the termination date (provided that, with respect to any equity award that is a restricted stock unit, including the PRSUs, in no event shall such restricted stock unit be settled later than the March 15 of the calendar year following the year in which the termination date occurs) (the “Partial Equity Acceleration” and collectively, the “Severance Benefits”).

(c) Termination by the Company Without Cause or by the Executive With Good Reason Within Twelve Months Following a Change in Control. If a Qualifying Termination occurs within twelve (12) months following a Change in Control, then the Executive shall be entitled to the Accrued Obligations. In addition, and subject to the conditions of Section 8(d): (i) the Executive will be eligible to receive the Severance Benefits as set forth in Section 8(b) other than the Pro-Rated Bonus Payment and Partial Equity Acceleration, subject to the same terms, conditions and limitations described therein, (ii) in lieu of the Pro-Rated Bonus Payment, the Executive will be eligible to receive a lump sum payment equal to 100% of the Executive’s Target Bonus for the year in which the Qualifying Termination occurs without regard to whether the performance goals applicable to such Target Bonus had been established or satisfied at the date of termination of employment, payable in a lump sum on the Payment Date; and (iii) in lieu of the Partial Equity Acceleration, all of the Executive’s then-unvested equity awards (including the Equity Awards) shall vest and become fully exercisable or non-forfeitable effective as of the termination date (provided that, with respect to any equity award that is a restricted stock unit, including the PRSUs, in no event shall such restricted stock unit be settled later than the March 15 of the calendar year following the year in which the termination date occurs) (collectively, the “Change in Control Severance Benefits”).

(d) Release . As a condition of the Executive’s receipt of the Earned but Unpaid Bonus, the Severance Benefits or the Change in Control Severance Benefits, as applicable, the Executive or his estate, as applicable, must execute and deliver to the Company a severance and release of claims agreement in substantially the form attached hereto (the “Severance Agreement”), which Severance Agreement must become irrevocable within 60 days following the date of the Executive’s termination of employment (or such shorter period as may be directed by the Company). The Earned but Unpaid Bonus, the Severance Benefits or the Change in Control Severance Benefits, as applicable, will be paid or commence to be paid in the first regular payroll beginning after the Severance Agreement becomes effective, provided that if the foregoing 60 day period would end in a calendar year subsequent to the year in which the Executive’s employment ends, the Earned but Unpaid Bonus, the Severance Benefits or Change in Control Severance Benefits, as applicable, will not be paid or begin to be paid before the first payroll of the subsequent calendar year (the date the Earned but Unpaid Bonus, the Severance Benefits or Change in Control Severance Benefits, as applicable, commence pursuant to this sentence, the “Payment Date”). The Executive must continue to comply with the Proprietary Rights, Non-Disclosure, Developments and Non-Solicitation Agreement in order to be eligible to continue receiving the Severance Benefits or Change in Control Severance Benefits, as applicable.

(e) Change in Control Definition . For purposes of this Agreement, Change in Control shall mean: (i) an exclusive license of or the sale, the lease or other disposal of all or substantially all of the assets of the Company; (ii) a sale or other disposal (for the avoidance of doubt, the term disposal shall not include a pledge) in any transaction or series of transactions to which the Company is a party of 50% or more of the voting power of the Company, other than any transaction or series of transactions principally for bona fide equity financing purposes in which cash is received by the Company or indebtedness of the Company is cancelled or converted, or a combination thereof; (iii) a merger or consolidation of the Company with or into any third party, other than any merger or consolidation in which the shares of the Company immediately preceding such merger or consolidation continue to represent a majority of the voting power of the surviving entity immediately after the closing of such merger or consolidation; and (iv) a liquidation, winding up or any other form of dissolution of the Company. For purposes of this Agreement, a Change in Control shall also mean the occurrence of any of the transactions described in the immediately preceding sentence in respect of the Parent.

9. Modified Section 280G Cutback . Notwithstanding any other provision of this Agreement, except as set forth in Section 9(b), in the event that the Company undergoes a “Change in Ownership or Control” (as defined below), the following provisions shall apply:

(a) The Company shall not be obligated to provide to the Executive any portion of any “Contingent Compensation Payments” (as defined below) that the Executive would otherwise be entitled to receive to the minimum extent necessary to eliminate any “excess parachute payments” (as defined in Section 280G(b)(1) of the Code) for the Executive. For purposes of this Section 9, the Contingent Compensation Payments so eliminated shall be referred to as the “Eliminated Payments” and the aggregate amount (determined in accordance with Treasury Regulation Section 1.280G-1, Q/A-30 or any successor provision) of the Contingent Compensation Payments so eliminated shall be referred to as the “Eliminated Amount.”

(b) Notwithstanding the provisions of Section 9(a), no such reduction in Contingent Compensation Payments shall be made if (1) the net amount of such Contingent Compensation Payments, as so reduced by the Eliminated Amount (computed without regard to this sentence) (but after subtracting the amount of any taxes that would be incurred by the Executive on such reduced Contingent Compensation Payments (including state and federal income taxes on the reduced Contingent Compensation Payments and any withholding taxes)) is less than (2) the net amount of such Contingent Compensation Payments without such reduction (but after subtracting the amount of any taxes that would be incurred by the Executive on the Contingent Compensation Payments if the Eliminated Payments (determined without regard to this sentence) were paid to the Executive (including state and federal income taxes on the Contingent Compensation Payments, the excise tax imposed by Section 4999 of the Code payable with respect to all of the Contingent Compensation Payments in excess of the Executive’s “base amount” (as defined in Section 280G(b)(3) of the Code), and any withholding taxes)). The override of such reduction in Contingent Compensation Payments pursuant to this Section 9(b) shall be referred to as a “Section 9(b) Override.”

(i) “Change in Ownership or Control” shall mean a change in the ownership or effective control of the Company or in the ownership of a substantial portion of the assets of the Company determined in accordance with Section 280G(b)(2) of the Code.

(ii) “Contingent Compensation Payment” shall mean any payment (or benefit) in the nature of compensation that is made or made available (under this Agreement or otherwise) to or for the benefit of a “disqualified individual” (as defined in Section 280G(c) of the Code) and that is contingent (within the meaning of Section 280G(b)(2)(A)(i) of the Code) on a Change in Ownership or Control of the Company.

(d) The Contingent Compensation Payments to be treated as Eliminated Payments shall be determined by the Company in a manner that results in the maximum economic benefit to the Executive on an after-tax basis. Except to the extent that an alternative reduction order would result in a greater economic benefit to the Executive on an after-tax basis, the Parties intend that such reduction be determined by the 280G Firm (as defined below) by determining the “Contingent Compensation Payment Ratio” (as defined below) for each Contingent Compensation Payment and then reducing the Contingent Compensation Payments in order beginning with the Contingent Compensation Payment with the highest Contingent Compensation Payment Ratio; provided that, notwithstanding the foregoing, any such reduction shall be undertaken in a manner that complies with and does not result in the imposition of additional taxes on the Executive under Section 409A of the Code. For Contingent Compensation Payments with the same Contingent Compensation Payment Ratio, such Contingent Compensation Payment shall be reduced based on the time of payment of such Contingent Compensation Payments with amounts having later payment dates being reduced first. For Contingent Compensation Payments with the same Contingent Compensation Payment Ratio and the same time of payment, such Contingent Compensation Payments shall be reduced on a pro rata basis (but not below zero) prior to reducing Contingent Compensation Payment with a lower Contingent Compensation Payment Ratio. The term “Contingent Compensation Payment Ratio” shall mean a fraction the numerator of which is the value of the applicable Contingent Compensation Payment for purposes of Section 4999(a) of the Code, and the denominator of which is the actual amount received by the Executive in respect of the applicable Contingent Compensation Payment. For example, in the case of an equity grant that is treated as contingent on the Change in Ownership or Control because the time at which the payment is made or the payment vests is accelerated, the denominator shall be determined by reference to the fair market value of the equity at the acceleration date, and not in accordance with the methodology for determining the value of accelerated payments set forth in Treasury Regulation Section 1.280G-1 Q/A-24(b) or (c)).

(e) All determinations regarding the application of this Section 9 shall be made by an accounting firm, law firm or consulting group with nationally recognized standing and substantial expertise and experience in performing calculations regarding the applicability of Section 280G of the Code and the Excise Tax retained by the Company prior to the date of the applicable change in control and reasonably acceptable to the Executive (the “ 280G Firm ”). The 280G Firm will be directed to submit its determination and detailed supporting calculations to

both the Executive and the Company within thirty (30) days after notification from either the Company or the Executive that the Executive may receive payments which may be Contingent Compensation Payments (or such earlier or later date as the Company and Executive may agree). The Executive and the Company will each provide the 280G Firm access to and copies of any books, records, and documents in their possession as may be reasonably requested by the 280G Firm, and otherwise cooperate with the 280G Firm in connection with the preparation and issuance of the determinations and calculations contemplated by this letter agreement. The fees and expenses of the 280G Firm for its services in connection with the determinations and calculations contemplated by this Section 9 will be borne by the Company. The costs of obtaining such determination and all related fees and expenses (including related fees and expenses incurred in any later audit) shall be borne by the Company.

(f) The provisions of this Section 9 are intended to apply to any and all payments or benefits available to the Executive under this Agreement or any other agreement or plan under which the Executive receives Contingent Compensation Payments.

10. Absence of Restrictions . The Executive represents and warrants that the Executive is not bound by any employment contracts, restrictive covenants or other restrictions that prevent the Executive from entering into employment with, or carrying out the Executive’s responsibilities for, the Company and the Parent, or which are in any way inconsistent with any of the terms of this Agreement.

11. Notice . Any notice delivered under this Agreement shall be deemed duly delivered three (3) business days after it is sent by registered or certified mail, return receipt requested, postage prepaid, one (1) business day after it is sent for next-business day delivery via a reputable nationwide overnight courier service, or immediately upon hand delivery, in each case to the address of the recipient set forth below.

To Executive:

At the address set forth in the Executive’s personnel file

To Company:

Nabriva Therapeutics US, Inc.
1000 Continental Drive
King of Prussia, PA 19406 USA
Attention: General Counsel

Either Party may change the address to which notices are to be delivered by giving notice of such change to the other Party in the manner set forth in this Section 11.

12. Applicable Law; Jury Trial Waiver . This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Pennsylvania (without reference to the conflict of laws provisions thereof). The Company and the Executive each hereby irrevocably waives any right to a trial by jury in any action, suit or other legal proceeding arising under or relating to any provision of this Agreement.

13. Successors and Assigns . This Agreement shall be binding upon and inure to the benefit of both Parties and their respective successors and assigns, including any corporation with which or into which the Company may be merged or which may succeed to its assets or business; provided, however, that the obligations of the Executive are personal and shall not be assigned by the Executive. Notwithstanding the foregoing, in the event of the Executive’s death, his rights to any payments or benefits hereunder to which he is or becomes entitled to at the time of his death may be assigned or transferred by the laws of descent and distribution and any such payments or benefits will be provided to his beneficiaries or his estate, as applicable.

14. Effect of Section 409A of the Code .

(a) Six Month Delay . If and to the extent any portion of any payment, compensation or other benefit provided to the Executive in connection with the Executive’s employment termination is determined to constitute “nonqualified deferred compensation” within the meaning of Section 409A of the Code and the Executive is a specified employee as defined in Section 409A(a)(2)(B)(i) of the Code, as determined by the Company in accordance with its procedures, by which determination Executive hereby agrees that the Executive is bound, such portion of the payment, compensation or other benefit shall not be paid before the earlier of (i) the expiration of the six month period measured from the date of the Executive’s “separation from service” (as determined under Section 409A of the Code) and (ii) the tenth day following the date of the Executive’s death following such separation from service (the “New Payment Date”). The aggregate of any payments that otherwise would have been paid to the Executive during the period between the date of separation from service and the New Payment Date shall be paid to the Executive in a lump sum in the first payroll period beginning after such New Payment Date, and any remaining payments will be paid on their original schedule.

(b) General 409A Principles . For purposes of this Agreement, a termination of employment will mean a “separation from service” as defined in Section 409A of the Code, each amount to be paid or benefit to be provided will be construed as a separate identified payment for purposes of Section 409A of the Code, and any payments that are due within the “short term deferral period” as defined in Section 409A of the Code or are paid in a manner covered by Treas. Reg. Section 1.409A-1(b)(9)(iii) will not be treated as deferred compensation unless applicable law requires otherwise. Neither the Company nor the Executive will have the right to accelerate or defer the delivery of any such payments or benefits except to the extent specifically permitted or required by Section 409A of the Code. This Agreement is intended to comply with the provisions of Section 409A of the Code and this Agreement shall, to the extent practicable, be construed in accordance therewith. Terms defined in this Agreement will have the meanings given such terms under Section 409A of the Code if and to the extent required to comply with Section 409A of the Code. In any event, the Company makes no representations or warranty and will have no liability to the Executive or any other person if any provisions of or payments under this Agreement are determined to constitute deferred compensation subject to Section 409A of the Code but not to satisfy the conditions of that section.

15. Acknowledgment . The Executive states and represents that the Executive has had an opportunity to fully discuss and review all of the terms of this Agreement with an attorney of his own choosing, and that Executive has done so. The Executive further states and represents that the Executive has carefully read this Agreement, understands the contents herein, freely and

voluntarily assents to all of the terms and conditions hereof, and signs the Executive’s name of the Executive’s own free act.

16. No Oral Modification, Waiver, Cancellation or Discharge . This Agreement may be amended or modified only by a written instrument executed by both the Company and the Executive. No delay or omission by the Company in exercising any right under this Agreement shall operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar to or waiver of any right on any other occasion.

17. Captions and Pronouns . The captions of the sections of this Agreement are for convenience of reference only and in no way define, limit or affect the scope or substance of any section of this Agreement. Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular forms of nouns and pronouns shall include the plural, and vice versa.

18. Interpretation . The Parties agree that this Agreement will be construed without regard to any presumption or rule requiring construction or interpretation against the drafting Party. References in this Agreement to “include” or “including” should be read as though they said “without limitation” or equivalent forms.

19. Severability . Each provision of this Agreement must be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement. Moreover, if a court of competent jurisdiction determines any of the provisions contained in this Agreement to be unenforceable because the provision is excessively broad in scope, whether as to duration, activity, geographic application, subject or otherwise, it will be construed, by limiting or reducing it to the extent legally permitted, so as to be enforceable to the extent compatible with then applicable law to achieve the intent of the Parties.

20. Entire Agreement . This Agreement constitutes the entire agreement between the Parties and supersedes all prior agreements and understandings, whether written or oral, relating to the subject matter of this Agreement.

[Signatures on Page Following]

IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the 23rd of July, 2018.

NABRIVA THERAPEUTICS US, INC.		EXECUTIVE

By:	/s/ Gary Sender	/s/ Theodore R. Schroeder
Name:	Gary Sender	Theodore R. Schroeder
Title:	Chief Financial Officer

Attachment A

Attachment to Employment Agreement

To be delivered with respect to

severance benefits(1)

SEPARATION AND RELEASE OF CLAIMS AGREEMENT

This Separation and Release of Claims Agreement (the “ Agreement ”) is made as of the Agreement Effective Date (as defined below) between Nabriva Therapeutics US, Inc. (the “ Company ”) and (“ Executive ”) (together, the “ Parties ”).

RECITALS

WHEREAS , the Company and Executive are parties to the Employment Agreement dated as of (the “ Employment Agreement ”), under which Executive currently serves as President and Chief Executive Officer of the Company and Chief Executive Officer of its group of companies;

WHEREAS , the Parties are ending their employment relationship and wish to establish mutually agreeable terms for Executive’s orderly transition and separation from the Company effective on the Separation Date (as defined below); and

WHEREAS , the Parties agree that the payments, benefits and rights set forth in this Agreement shall be the exclusive payments, benefits and rights due Executive.

1. Separation Date — Executive’s effective date of separation from employment with the Company and, as may be applicable, any and all of its parents, affiliates and subsidiaries, including, without limitation, Nabriva Therapeutics GMBH and Nabriva Therapeutics plc (the “ Parent ”) (together, the “ Affiliates ”), will be (the “ Separation Date ”). Executive hereby resigns, as of the Separation Date, from any and all of his positions as a

(1) NTD: The Parties agree that the Company may revise this release agreement to reflect changes in law, additional statutes or claims, benefits, or your circumstances, so that the Company receives the benefit of the most complete release of claims that is legally permissible and may also change the timing, if required to obtain such release. This footnote and any other footnotes are part of the form of release agreement and are to be removed only when the Company finalizes the Separation and Release of Claims Agreement for execution. If the release is as a result of Executive’s death, the Company will revise and provide for a comparable release by the Executive’s estate or beneficiaries.

member of the board of directors and/or as an officer of the Company and each of its Affiliates, and Executive further agrees to execute and deliver any documents reasonably necessary to effectuate such resignations, provided that nothing in any such document is inconsistent with any terms set forth in this Agreement. As of the Separation Date, all salary payments from the Company will cease and any benefits Executive had as of such date under Company-provided benefit plans, programs, or practices will terminate, except as required by federal or state law or as otherwise specifically set forth in this Agreement.

2. Severance Benefits — In return for Executive’s timely signing and not revoking this Agreement as set forth in Section 15 below, and subject to Executive’s compliance with all terms hereof, the Company will provide Executive with [INSERT per Employment Agreement, as may be applicable] (the “ Severance Benefits ”). Other than the Severance Benefits, Executive will not be eligible for, nor shall he have a right to receive, any payments or benefits from the Company or the Parent following the Separation Date, other than reimbursement for any outstanding business expenses in accordance with Company policy.

3. Release of Claims — In exchange for the consideration set forth in this Agreement, which Executive acknowledges he would not otherwise be entitled to receive, Executive hereby fully, forever, irrevocably and unconditionally releases, remises and discharges the Company, its affiliates (including, without limitation, the Parent), subsidiaries, parent companies, predecessors, and successors, and all of its and their respective past and present officers, directors, stockholders, investors, partners, members, managers, employees, agents, representatives, plan administrators, attorneys, insurers and fiduciaries (each in their individual and corporate capacities) (collectively, the “ Released Parties ”) from any and all claims, complaints, demands, actions, causes of action, suits, rights, debts, sums of money, costs, accounts, reckonings, covenants, contracts, agreements, promises, doings, omissions, damages, executions, obligations, liabilities, and expenses (including attorneys’ fees and costs), of every kind and nature that Executive ever had or now has against any or all of the Released Parties, whether known or unknown, including, but not limited to, any and all claims arising out of or relating to Executive’s employment with and/or separation from the Company, including, but not limited to, all claims under Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e et seq. , the Americans With Disabilities Act of 1990, 42 U.S.C. § 12101 et seq. , the Age Discrimination in Employment Act, 29 U.S.C. § 621 et seq. , the Genetic Information Nondiscrimination Act of 2008, 42 U.S.C. § 2000ff et seq. , the Family and Medical Leave Act, 29 U.S.C. § 2601 et seq. , the Worker Adjustment and Retraining Notification Act (“ WARN ”), 29 U.S.C. § 2101 et seq. , the Rehabilitation Act of 1973, 29 U.S.C. § 701 et seq. , Executive Order 11246, Executive Order 11141, the Fair Credit Reporting Act, 15 U.S.C. § 1681 et seq. , and the Employee Retirement Income Security Act of 1974 (“ ERISA ”), 29 U.S.C. § 1001 et seq. , all as amended; all claims arising out of the Pennsylvania Human Relations Act, 43 Pa. Stat. § 951 et seq. , the Pennsylvania Equal Pay Law, 43 Pa. Stat. § 336.1 et seq. , and the Pennsylvania Whistleblower Law, 43 Pa. Stat. § 1421 et seq. , all as amended; all claims arising out of the California Fair Employment and Housing Act, Cal. Gov’t. Code § 12900 et seq ., Cal. Labor Code § 201 et seq . (California payment of wages law), the California Equal Pay Act, Cal. Lab. Code

§ 1197.5 et seq ., the California Family Rights Act, Cal. Gov’t. Code § 12945.2 and § 19702.3, the Cal-WARN Act, Cal. Lab. Code §§ 1400-1408, Cal. Lab. Code § 233 (California’s kin care law), Cal. Lab. Code § 230.8 (California leave for school activities law), Cal. Lab. Code § 245.5 (California paid sick leave law), Cal. Lab. Code §§ 230 and 230.1 (California domestic violence leave law), Cal. Mil. And Vet. Code § 395.10 (California military family leave law), Cal. Code Regs. tit. 2, §§ 11035-11051 (California’s pregnancy leave law), California Unruh Civil Rights Act, Cal. Civ. Code § 51 et seq., and Cal. Lab. Code §§ 98.6 and 1102.5 (California whistleblower protection laws), all as amended; all common law claims including, but not limited to, actions in defamation, intentional infliction of emotional distress, misrepresentation, fraud, wrongful discharge, and breach of contract (including, without limitation, all claims arising out of or related to the Employment Agreement); all claims to any non-vested ownership interest in the Company, contractual or otherwise; all state and federal whistleblower claims to the maximum extent permitted by law; and any claim or damage arising out of Executive’s employment with and/or separation from the Company (including a claim for retaliation) under any common law theory or any federal, state or local statute or ordinance not expressly referenced above; provided, however, that nothing in this release of claims prevents Executive from filing a charge with, cooperating with, or participating in any investigation or proceeding before, the Equal Employment Opportunity Commission or a state fair employment practices agency (except that Executive acknowledges that he may not recover any monetary benefits in connection with any such charge, investigation, or proceeding, and Executive further waives any rights or claims to any payment, benefit, attorneys’ fees or other remedial relief in connection with any such charge, investigation or proceeding). Further, nothing herein shall prevent Executive from bringing claims to enforce this Agreement, or release (i) any rights Executive may have under the Company’s certificate of incorporation, by-laws, insurance and/or any indemnification agreement between him and the Company (and/or otherwise under law) for indemnification and/or defense as an employee, officer or director of the Company for his service to the Company (recognizing that such indemnification and/or defense is not guaranteed by this Agreement and shall be governed by the instrument or law, if any, providing for such indemnification and/or defense), (ii) any rights Executive may have to vested pension or 401(k) benefits or interests under any ERISA-Covered benefit plan (excluding severance) provided by the Company, or (iii) any rights or claims that cannot be waived by law, including claims for unemployment benefits.

4. Section 1542 Waiver — Executive understands and agree that the claims released in Section 3 above include not only claims presently known to Executive, but also include all unknown or unanticipated claims, rights, demands, actions, obligations, liabilities, and causes of action of every kind and character that would otherwise come within the scope of the released claims as described in Section 3. Executive understands that he may hereafter discover facts different from what he now believes to be true, which if known, could have materially affected this Agreement, but Executive nevertheless waives any claims or rights based on different or additional facts. Executive knowingly and voluntarily waive any and all rights or benefits that he may now have, or in the future may have, under the terms of Section 1542 of the Civil Code of the State of California, which provides as follows:

A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN BY HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.

5. Continuing Obligations — Executive acknowledges and reaffirms his obligation, to the extent permitted by law and except as otherwise permitted by Section 9 below, to keep confidential and not to use or disclose any and all non-public information concerning the Company and/or its Affiliates that Executive acquired during the course of his employment with the Company and/or its Affiliates, including, but not limited to, any non-public information concerning the Company’s and/or its Affiliates’ business affairs, business prospects, and financial condition. Executive further acknowledges and reaffirms his obligations set forth in the Proprietary Rights, Non-Disclosure, Developments and Non-Solicitation Agreement that he previously executed for the benefit of the Company (the “ NDA ”), which remain in full force and effect and which survive his separation from employment with the Company.

6. Non-Disparagement — Executive understands and agrees that, to the extent permitted by law and except as otherwise permitted by Section 9 below, he will not, in public or private, make any disparaging, derogatory or defamatory statements to any person or entity, including, but not limited to, any media outlet, industry group, financial institution or current or former employee, board member, consultant, client or customer of the Company, regarding the Company or, its affiliates (including, without limitation, the Parent), subsidiaries, parent companies, predecessors, and successors, and all of its and their respective past and present officers, directors, members, managers or employees or regarding the Company’s business affairs, business prospects, or financial condition; provided, however, that nothing herein shall be construed as preventing Executive from making truthful disclosures in any litigation or arbitration.

7. Return of Company Property — Executive confirms that he has returned to the Company or, with the written permission of the Company’s board of directors, destroyed, all keys, files, records (and copies thereof), equipment (including, but not limited to, computer hardware, software and printers, wireless handheld devices, cellular phones, tablets, etc.), Company identification and any other Company-owned property in his possession or control and, other than with the written permission of the Company’s board of directors, has left intact all electronic Company documents, including but not limited to those that he developed or helped to develop during his employment. Executive further confirms that, to the extent requested by the Company, he has canceled all accounts for his benefit, if any, in the Company’s name, including but not limited to, credit cards, telephone charge cards, cellular phone and/or wireless data accounts and computer accounts.

8. Confidentiality — Executive understands and agrees that, to the extent permitted by law and except as otherwise permitted by Section 9 below, the contents of the negotiations and discussions resulting in this Agreement shall be maintained as confidential by Executive and his agents and representatives and shall not be disclosed except as

otherwise agreed to in writing by the Company; provided, however, that nothing herein shall be construed as preventing Executive from making truthful disclosures in any litigation or arbitration or from having confidential conversations with his agents and representatives and family members on the condition that any individuals so informed must hold the above information in strict confidence.

9. Scope of Disclosure Restrictions — Nothing in this Agreement or elsewhere prohibits Executive from communicating with government agencies about possible violations of federal, state, or local laws or otherwise providing information to government agencies, filing a complaint with government agencies, or participating in government agency investigations or proceedings. Executive is not required to notify the Company of any such communications; provided, however, that nothing herein authorizes the disclosure of information Executive obtained through a communication that was subject to the attorney-client privilege. Further, notwithstanding Executive’s confidentiality and nondisclosure obligations, Executive is hereby advised as follows pursuant to the Defend Trade Secrets Act: “An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (A) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. An individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual (A) files any document containing the trade secret under seal; and (B) does not disclose the trade secret, except pursuant to court order.”

10. Cooperation — Executive agrees that, to the extent permitted by law, he shall cooperate fully with the Company in the investigation, defense or prosecution of any claims or actions which already have been brought, are currently pending, or which may be brought in the future against the Company by a third party or by or on behalf of the Company against any third party, whether before a state or federal court, any state or federal government agency, or a mediator or arbitrator, that relate in any manner to Executive’s conduct or duties at the Company or that are based on facts about which Executive obtained personal knowledge while employed at or providing services to the Company. Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with the Company’s counsel, at reasonable times and locations designated by the Company, to investigate or prepare the Company’s claims or defenses, to prepare for trial or discovery or an administrative hearing, mediation, arbitration or other proceeding and to act as a witness when requested by the Company. Any reasonable out-of-pocket expenses incurred by Employee associated with such cooperation will be paid for or reimbursed by the Company. Executive further agrees that, to the extent permitted by law, he will notify the Company promptly in the event that he is served with a subpoena (other than a subpoena issued by a government agency), or in the event that he is asked to provide a third party (other than a government agency) with information concerning any actual or potential complaint or claim against the Company.

11. Business Expenses and Final Compensation — Executive acknowledges that he has been reimbursed by the Company for all business expenses incurred in conjunction with the performance of his employment and that no other reimbursements are owed to him. Executive acknowledges that he has received all compensation due to him from the Company, including, but not limited to, all wages, bonuses and accrued, unused vacation time, and that he is not eligible or entitled to receive any additional payments or consideration from the Company beyond that provided for in Section 2 of this Agreement.

12. Amendment and Waiver — This Agreement shall be binding upon the Parties and may not be modified in any manner, except by an instrument in writing of concurrent or subsequent date signed by duly authorized representatives of the Parties. This Agreement is binding upon and shall inure to the benefit of the Parties and their respective agents, assigns, heirs, executors/administrators/personal representatives, and successors. No delay or omission by the Company in exercising any right under this Agreement shall operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar to or waiver of any right on any other occasion.

13. Validity — Should any provision of this Agreement be declared or be determined by any court of competent jurisdiction to be illegal or invalid, the validity of the remaining parts, terms or provisions shall not be affected thereby and said illegal or invalid part, term or provision shall be deemed not to be a part of this Agreement.

14. Nature of Agreement — The Parties understand and agree that this Agreement is a transition and separation agreement and that nothing herein constitutes an admission of liability or wrongdoing on the part of the Company or Executive.

15. Time for Consideration and Revocation — Executive acknowledges that he was initially presented with this Agreement on (the “ Receipt Date ”). Executive understands that this Agreement shall be of no force or effect, and that he shall not be eligible for the consideration described herein, unless he signs and returns this Agreement [on, but not before, the Separation Date (provided, however, that if the Separation Date is fewer than twenty-one (21) days following the Receipt Date, Executive must sign and return this Agreement no earlier than the Separation Date and no later than the 22 nd day after the Receipt Date) (2)] and does not revoke his acceptance in the subsequent seven (7) day period (the day immediately following expiration of such revocation period, the “ Agreement Effective Date ”).

16. Acknowledgments — Executive acknowledges that he has been given at least twenty-one (21) days to consider this Agreement, and that the Company is hereby advising him to consult with an attorney of his own choosing prior to signing this Agreement. Executive understands that he may revoke this Agreement for a period of seven (7) days after he signs it by notifying the Company in writing, and the Agreement shall not be effective or enforceable until the expiration of this seven (7) day revocation period. Executive

(2) NTD: Timing may change, and the Company may designate a period of up to 60 days in its sole discretion.

understands and agrees that by entering into this Agreement he will be waiving any and all rights or claims he might have under the Age Discrimination in Employment Act, as amended by the Older Workers Benefit Protection Act, and that he has received consideration beyond that to which he was previously entitled.

17. Voluntary Assent — Executive affirms that no other promises or agreements of any kind have been made to or with Executive by any person or entity whatsoever to cause him to sign this Agreement, and that he fully understands the meaning and intent of this Agreement. Executive further states and represents that he has carefully read this Agreement, understands the contents herein, freely and voluntarily assents to all of the terms and conditions hereof, and signs his name of his own free act.

18. Applicable Law — This Agreement shall be interpreted and construed by the laws of the Commonwealth of Pennsylvania, without regard to conflict of laws provisions. Executive hereby irrevocably submits to and acknowledges and recognizes the jurisdiction of the courts of the Commonwealth of Pennsylvania, or if appropriate, a federal court located in the Commonwealth of Pennsylvania (which courts, for purposes of this Agreement, are the only courts of competent jurisdiction), over any suit, action or other proceeding arising out of, under or in connection with this Agreement or the subject matter hereof. The Company and Executive each hereby irrevocably waives any right to a trial by jury in any action, suit or other legal proceeding arising under or relating to this Agreement or Executive’s employment with or separation from the Company.

19. Entire Agreement — This Agreement contains and constitutes the entire understanding and agreement between the Parties hereto with respect to Executive’s transition and separation from the Company, severance benefits and the settlement of claims against the Company, and cancels all previous oral and written negotiations, agreements, commitments and writings in connection therewith; provided, however, that nothing in this Section shall modify, cancel or supersede Executive’s obligations set forth in Section 5 above.

20. Tax Acknowledgement — In connection with the Severance Benefits provided to Executive pursuant to this Agreement, the Company shall withhold and remit to the tax authorities the amounts required under applicable law, and Executive shall be responsible for all applicable taxes owed by him with respect to such Severance Benefits under applicable law. Executive acknowledges that he is not relying upon the advice or representation of the Company with respect to the tax treatment of any of the Severance Benefits set forth in this Agreement.

21. Section 409A - This Agreement, and all payments hereunder, are intended to be exempt from, or if not so exempt, to comply with the requirements of, Section 409A of the Internal Revenue Code of 1986, as amended, and the guidance issued thereunder (“ Section 409A ”), and this Agreement shall be interpreted and administered accordingly. Notwithstanding anything to the contrary in this Agreement, if at the time of Executive’s termination of employment or otherwise when any Severance Benefit is payable hereunder, he is a “specified employee” as defined under Section 409A, any and all amounts payable hereunder on account of such termination of employment that would

(but for this provision) be payable within six (6) months following the Separation Date, shall instead be paid on the next business day following the expiration of such six (6) month period or, if earlier, upon Executive’s death; except to the extent of amounts that do not constitute a deferral of compensation within the meaning of Treasury regulation Section 1.409A — 1(b) or other amounts or benefits that are exempt from or otherwise not subject to the requirements of Section 409A. For purposes of this Agreement, whether or not a termination of employment has occurred shall be determined consistently with Section 409A. In addition, each payment made pursuant to the Agreement shall be treated as a separate payment and the right to a series of installment payments hereunder is to be treated as a right to a series of separate payments. Neither the Company, nor the Parent, nor any of their agents or affiliates shall have any liability to Executive should the benefits and payments hereunder that are intended to be exempt from or compliant with Section 409A, not be so exempt or compliant.

22. Counterparts — This Agreement may be executed in several counterparts, each of which shall be deemed to be an original, but all of which together will constitute one and the same agreement. Facsimile and PDF signatures shall be deemed to be of equal force and effect as originals.

IN WITNESS WHEREOF, the Parties have set their hands and seals to this Agreement as of the date(s) written below.

Nabriva Therapeutics US, Inc.

			Date:
By:

I hereby agree to the terms and conditions set forth above. I have been given at least twenty-one (21) days to consider this Agreement and I have chosen to execute this on the date below. I intend that this Agreement will become a binding agreement if I do not revoke my acceptance within seven (7) days.

[Executive Name]

			Date:

Exhibit 23.1

CONSENT OF INDEPENDENT AUDITORS

We consent to the incorporation by reference in the following Registration Statements:

1) Registration Statement (Form S-3 No. 333-219567) of Nabriva Therapeutics plc,

2) Registration Statement (Form S-3 No. 333-223739) of Nabriva Therapeutics plc,

3) Registration Statement (Form S-8 No. 333-208097) pertaining to the Stock Option Plan 2007 and Stock Option Plan 2015 of Nabriva Therapeutics plc, and

4) Registration Statement (Form S-8 No. 333-222003) pertaining to the 2017 Share Incentive Plan of Nabriva Therapeutics plc

of our report dated May 18, 2018, with respect to the financial statements of Zavante Therapeutics, Inc., included in this Current Report on Form 8-K of Nabriva Therapeutics plc dated July 25, 2018.

	/s/ Ernst & Young LLP

San Diego, California
July 24, 2018

Exhibit 99. 1

ITEM 1A. RISK FACTORS

You should consider carefully the risks and uncertainties described below, together with all of the other information in our annual and quarterly reports and other filings with the U.S. Securities and Exchange Commission, or the SEC. If any of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. The risks described below are not the only risks facing us. Risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, results of operations and/or prospects.

Risks Related to Our Recent Acquisition of Zavante

We may fail to realize the anticipated benefits of our Acquisition of Zavante, those benefits may take longer to realize than expected, and we may encounter significant integration difficulties.

On July 24, 2018, we completed our acquisition of Zavante Therapeutics, Inc., or Zavante, pursuant to an Agreement and Plan of Merger, or the Acquisition Agreement, dated July 23, 2018. Our ability to realize the anticipated benefits of the Acquisition will depend, to a large extent, on our ability to integrate Zavante and CONTEPO into our business and business strategy and realize anticipated growth opportunities and synergies. We expect that the integration process will be complex, costly and time-consuming. As a result, we will be required to devote significant management attention and resources to integrating Zavante into our business and CONTEPO into our business strategy. The integration process may be disruptive to our business and the expected benefits may not be achieved within the anticipated time frame, or at all. The failure to meet the challenges involved and to realize the anticipated benefits of the Acquisition could cause an interruption of, or a loss of momentum in, our development and commercialization efforts, including with respect to lefamulin and CONTEPO, and could adversely affect our business, financial condition and results of operations.

Our ability to realize the anticipated benefits of the Acquisition is expected to entail numerous additional material potential difficulties, including, among others:

· any delay or failure in obtaining marketing approvals for CONTEPO, or any delay or failure to commercialize CONTEPO in the United States thereafter;

· increased scrutiny from third parties, including regulators, legislative bodies and enforcement agencies, including with respect to product pricing and commercialization matters;

· changes in laws or regulations that adversely impact the anticipated benefits of the Acquisition;

· challenges related to the perception by patients, the medical community and third-party payors of CONTEPO for the treatment of cUTI;

· disruptions to our manufacturing arrangements with third-party manufacturers, including our manufacturing and supply arrangements with respect to CONTEPO and disruptions to our third-party distribution channel;

· difficulties in managing the expanded operations of a larger and more complex company following the Acquisition;

· the diversion of management attention to integration matters;

· any challenges associated with our chief executive officer transition in connection with the Acquisition;

· difficulties in achieving the anticipated business opportunities and growth prospects from the Acquisition;

· the size of the treatable patient population for CONTEPO may be smaller than we believe it is;

· difficulties in assimilating Zavante employees and in attracting and retaining key personnel; and

· potential unknown liabilities, adverse consequences, unforeseen increased expenses or other unanticipated problems associated with the Acquisition.

Many of these factors are outside of our control, and any one of them could result in increased costs, decreased expected revenues and further diversion of management time and energy, which could materially adversely impact our business, financial condition and results of operations.

Upfront consideration for the Acquisition is comprised of 8,152,092 of our ordinary shares, including the 815,186 ordinary shares that are issuable upon release of the holdback shares subject to the terms of the Merger Agreement. Pursuant to the Acquisition Agreement, former Zavante stockholders are also entitled to receive from us, subject to the terms and conditions of the Acquisition Agreement, up to $97.5 million in contingent consideration, of which $25 million would become payable upon the first approval of a new drug application from the U.S. Food and Drug Administration, or the FDA, for CONTEPO for injection for any indication, or the Approval Milestone Payment, and an aggregate of up to $72.5 million would become payable upon the achievement of specified net sales milestones, or the Net Sales Milestone Payments. Subject to approval of our shareholders of the issuance of our ordinary shares in satisfaction of the milestone payments, the Approval Milestone Payment will be settled in our ordinary shares and we will have the right to settle the Net Sales Milestone Payments in ordinary shares. In the absence of obtaining such shareholder approval, all milestone payments will be settled in cash. The issuance of our ordinary shares in connection with the closing of the Acquisition was dilutive to our existing shareholders, and the future issuance of our ordinary shares to satisfy our milestone payment obligations would be further dilutive to our then existing shareholders. If we are unable to obtain shareholder approval

in connection with the Approval Milestone Payment, the need to satisfy this obligation in cash may have an adverse effect on our liquidity.

Also, following the Acquisition, we now possess certain liabilities and obligations, including contractual liabilities and obligations, that were assumed by us upon closing of the Acquisition. Prior to the Acquisition, former Zavante stockholders and SG Pharmaceuticals, Inc. entered into a stock purchase agreement, dated as of May 5, 2015, or the Stock Purchase Agreement, pursuant to which SG Pharmaceuticals, Inc. acquired all of the outstanding capital stock of Zavante from the Zavante selling stockholders and SG Pharmaceuticals, Inc., subsequently merged with and into Zavante, with Zavante as the surviving entity. Pursuant to the Stock Purchase Agreement, Zavante (as successor to SG Pharmaceuticals, Inc.) is obligated to make milestone payments to the selling stockholders of $3.0 million upon marketing approval by the FDA with respect to any oral, intravenous or other form of fosfomycin, or the Zavante Products, and milestone payments of up to $26 million in the aggregate upon the occurrence of various specified levels of net sales with respect to the Zavante Products. In addition, Zavante is obligated to make annual royalty payments to the Selling Stockholders of a mid single-digit percentage of net sales of Zavante Products, subject to adjustment based on net sales thresholds and with such percentage reduced to low single-digits if generic fosfomycin products account for half of the applicable market on a product-by-product and country-by-country basis. The Stock Purchase Agreement also provides that Zavante will pay to the Selling Stockholders a mid single-digit percentage of transaction revenue in connection with the consummation of the grant, sale, license or transfer of market exclusivity rights for a qualified infectious disease product (within the meaning of the 21st Century Cures Act, or the Cures Act) related to a Zavante Product.

In addition, we expect to incur expenses related to the continued development, regulatory approval process and commercialization with respect to CONTEPO. Zavante has entered into a manufacturing and supply agreement with Fisiopharma, S.r.l. pursuant to which Zavante has an obligation to purchase a minimum percentage of its commercial requirements of CONTEPO in the United States. Zavante has also entered into a manufacturing and exclusive supply agreement with Laboratorios ERN, S.A., pursuant to which Laboratorios ERN, S.A. has agreed to supply Zavante with certain technical documentation and data as required for submission of an NDA or an abbreviated new drug application for CONTEPO and certain regulatory support in connection with the commercial sale and use of CONTEPO in the United States, and which provides for payments to Laboratorios ERN, S.A. of a one-time cash payment upon the first commercial sale of CONTEPO and subsequent quarterly payments thereafter based on the number of vials of CONTEPO sold in the United States during each quarter.

Because we have limited financial resources, by investing in the Acquisition, we may forgo or delay pursuit of other opportunities that may have proven to have greater commercial potential. Further, it is possible that undisclosed, contingent, or other liabilities or problems may arise in the future of which we were previously unaware. These undisclosed liabilities could have an adverse effect on our business, financial condition and results of operations.

All of these factors could decrease or delay the expected accretive effect of the Acquisition and negatively impact our stock price. As a result, it cannot be assured that the Acquisition will

result in the full realization of the benefits anticipated from the Acquisition or in the anticipated time frames or at all.

Risks Related to Our Financial Position and Need for Additional Capital

We have incurred significant losses since our inception. We expect to incur losses for at least the next several years and may never generate profits from operations or maintain profitability.

Since inception, we have incurred significant operating losses. Our net losses were $13.3 million for the three months ended March 31, 2018, $74.4 million for the year ended December 31, 2017, $54.9 million for the year ended December 31, 2016 and $47.0 million for the year ended December 31, 2015. As of March 31, 2018, we had an accumulated deficit of $292.5 million. Zavante has also incurred net operating losses since its inception. Zavante’s net losses were $12,369,169 for the year ended December 31, 2017 and $23,501,886 for the year ended December 31, 2016. To date, we have financed our operations primarily through the sale of our equity securities, convertible loans and research and development support from governmental grants and loans. We have devoted substantially all of our efforts to research and development, including clinical trials. We have not completed development of any drugs. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years, including in connection with our continued development, regulatory approval efforts and commercialization of lefamulin and CONTEPO. The net losses we incur may fluctuate significantly from quarter-to-quarter and year-to-year.

In the first quarter of 2018, we re-evaluated the need for the previously planned expansion of our commercial organization, medical education, and supply chain activities and we reduced the cash required for the business through 2019. We expect to continue to invest in critical pre-commercialization activities prior to receiving marketing approval and making lefamulin and CONTEPO available to patients, if approved.

We initiated the our first Phase 3 global, pivotal clinical trial of lefamulin, which we refer to as Lefamulin Evaluation Against Pneumonia 1, or LEAP 1, in September 2015, and we initiated our second Phase 3 global, pivotal clinical trial of lefamulin, which we refer to as Lefamulin Evaluation Against Pneumonia 2, or LEAP 2, in April 2016. In September 2017, we announced positive topline results for LEAP 1. In December 2017, we announced completion of enrollment for LEAP 2. In May 2018, we announced positive topline results from LEAP 2. LEAP 2 evaluated the safety and efficacy of 5 days of oral lefamulin compared to 7 days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia, or CABP. We expect to submit a new drug application, or NDA, for marketing approval of lefamulin for the treatment of CABP in adults in the United States in the fourth quarter of 2018. We also expect to submit a marketing authorization application, or MAA, for lefamulin for the treatment of CABP in adults in Europe a few months after our NDA filing. We also continue to characterize the clinical pharmacology of lefamulin. If we obtain marketing approval of lefamulin for CABP or another indication, we also expect to incur significant additional sales, marketing, distribution and manufacturing expenses.

In June 2016, the first patient was enrolled by Zavante in its pivotal ZTI-01 Efficacy and Safety Study of CONTEPO, which we refer to as the ZEUS study. In April 2017, Zavante announced positive topline results of the ZEUS study. The ZEUS study was a multicenter, randomized, parallel-group, double-blind Phase 2/3, pivotal clinical trial designed to evaluate safety, tolerability, efficacy and pharmacokinetics of seven days of treatment, or up to 14 days of treatment for patients with concurrent bacteremia, with CONTEPO compared to piperacillin-tazobactam, or PIP-TAZ, in the treatment of hospitalized adults with cUTI or acute pyelonephritis, or AP. We expect to submit an NDA for marketing approval of CONTEPO for the treatment of cUTI, including AP, in the United States in the fourth quarter of 2018. In June 2018, Zavante initiated a Phase 1, non-comparative, open-label study of the pharmacokinetics and safety of a single dose of CONTEPO in pediatric subjects less than 12 years of age receiving standard-of-care antibiotic therapy for proven or suspected infection or peri-operative prophylaxis. We anticipate completing enrollment in this study in late 2020. We also intend to continue to characterize the clinical pharmacology of CONTEPO. If we obtain marketing approval of CONTEPO for cUTI, including AP, or another indication, we also expect to incur significant additional sales, marketing, distribution and manufacturing expenses.

On July 24, 2018, we completed our Acquisition of Zavante. Upfront consideration in connection with the Acquisition is 8,152,092 of our ordinary shares, including the 815,186 ordinary shares that are issuable upon release of the holdback shares subject to the terms of the Merger Agreement. Pursuant to the Acquisition Agreement, former Zavante stockholders are also entitled to receive from us up to $97.5 million in contingent consideration, consisting of the Approval Milestone Payment and the Net Sales Milestone Payment, subject to the terms and conditions of the Acquisition Agreement. In connection with the Acquisition, we assumed certain payment obligations under the Stock Purchase Agreement and Zavante manufacturing agreements acquired in the Acquisition. See “— Risks Related to Our Recent Acquisition of Zavante—We may fail to realize the anticipated benefits of our Acquisition of Zavante, those benefits may take longer to realize than expected, and we may encounter significant integration difficulties. ”

In addition, our expenses will increase if and as we:

· initiate or continue the research and development of lefamulin and CONTEPO for additional indications and of our other product candidates;

· seek to discover and develop additional product candidates;

· seek marketing approval for any product candidates that successfully complete clinical development;

· are required by the FDA, EMA or other regulators to conduct additional clinical trials prior to or after approval;

· continue to build a medical affairs, sales, marketing and distribution infrastructure and scale up manufacturing capabilities to commercialize any product candidates for which we receive marketing approval;

· in-license or acquire other products, product candidates or technologies;

· maintain, expand and protect our intellectual property portfolio;

· expand our physical presence in the United States and Ireland;

· establish and expand manufacturing arrangements with third parties; and

· add operational, financial and management information systems and personnel, including personnel to support our product development, our operations as a larger company following the Acquisition and our operations as a public company in addition to our planned future commercialization efforts.

Our ability to generate profits from operations, and to become and remain profitable, depends on our ability to successfully develop and commercialize drugs that generate significant revenue. Based on our current plans, we do not expect to generate significant revenue unless and until we obtain marketing approval for, and commercialize, lefamulin and CONTEPO. We do not expect to obtain marketing approval before 2019, if at all. This will require us to be successful in a range of challenging activities, including:

· applying for and obtaining marketing approval for lefamulin and CONTEPO;

· expanding medical affairs, sales, marketing and distribution capabilities to effectively market and sell lefamulin and CONTEPO in the United States;

· establishing and maintaining collaboration, distribution or other marketing arrangements with third parties to commercialize lefamulin in markets outside the United States;

· protecting our rights to our intellectual property portfolio related to lefamulin and CONTEPO;

· establishing and maintaining arrangements for the manufacture of and obtaining commercial quantities of lefamulin and CONTEPO; and

· negotiating and securing adequate reimbursement from third-party payors for lefamulin and CONTEPO.

We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to generate profits from operations. Even if we do generate profits from operations, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to generate profits from operations, and to become and remain profitable, would decrease the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or continue our operations. A decline in the value of our company could also cause our shareholders to lose all or part of their investment.

We will need substantial additional funding. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or future commercialization efforts.

We expect to continue to incur substantial costs in connection with our ongoing activities, particularly as we potentially seek marketing approval for lefamulin, CONTEPO and, possibly, other product candidates and continue our research activities. Our expenses will increase if we suffer any regulatory delays or are required to conduct additional clinical trials to satisfy regulatory requirements. If we obtain marketing approval for lefamulin, CONTEPO or any other product candidate that we develop, in-license or acquire, we expect to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing.

Furthermore, we expect to continue to incur additional costs associated with operating as a public company and as a larger company with a commercial rather than a research and development focus following the Acquisition. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.

We expect to seek additional funding in future periods for purposes of investment in our commercial and medical affairs organization, including the expansion of a targeted hospital based sales force and related infrastructure, as well as investing in our supply chain in an effort to enhance the potential commercial launch of lefamulin and CONTEPO.

Our future capital requirements will depend on many factors, including:

· the costs and timing of process development and manufacturing scale-up activities associated with lefamulin and CONTEPO;

· the costs, timing and outcome of regulatory review of lefamulin and CONTEPO;

· the costs of commercialization activities for lefamulin and CONTEPO if we receive, or expect to receive, marketing approval, including the costs and timing of establishing product sales, marketing, distribution and outsourced manufacturing capabilities, including the costs of building finished product inventory and its components in preparation of initial marketing of lefamulin and CONTEPO;

· subject to receipt of marketing approval, revenue received from commercial sales of lefamulin and CONTEPO;

· the costs of developing lefamulin and CONTEPO for the treatment of additional indications;

· our ability to establish collaborations on favorable terms, if at all;

· the scope, progress, results and costs of product development of any other product candidates that we may develop;

· the extent to which we in-license or acquire rights to other products, product candidates or technologies;

· the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against intellectual property-related claims;

· the continued availability of Austrian governmental grants;

· the rate of the expansion of our physical presence in the United States and Ireland;

· the costs of operating as a larger company with a commercial rather than a research and development focus following the Acquisition; and

· the costs of operating as a public company in the United States.

Our commercial revenues, if any, will be derived from sales of lefamulin, CONTEPO or any other products that we successfully develop, in-license or acquire, none of which we expect to be commercially available for more than a year, if at all. In addition, if approved, lefamulin, CONTEPO or any other product candidate that we develop, in-license or acquire may not achieve commercial success. Accordingly, we will need to obtain substantial additional financing to achieve our business objectives.

Adequate additional financing may not be available to us on acceptable terms, or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans.

Raising additional capital may cause dilution to our security holders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, and funding from local and international government entities and non-government organizations in the disease areas addressed by our product candidates and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a security holder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt service obligations under any debt financings may limit the availability of our cash for other purposes,

and we may be unable to make interest payments or repay the principal of such debt financings when due.

On March 16, 2018, we entered into a Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co., or Cantor Fitzgerald, as agent, pursuant to which we may offer and sell ordinary shares, nominal value $0.01 per share, for aggregate gross sale proceeds of up to $50,000,000 from time to time through Cantor Fitzgerald under an “at-the-market” offering program. As of July 24, 2018, $27.2 million of ordinary shares remained available for sale under our “at-the-market” offering. If a large number of our ordinary shares is sold in the public market after they become eligible for sale or if we make additional sales under our “at-the-market” offering program, the sales could cause dilution to our security holders, reduce the trading price of our ordinary shares and impede our ability to raise future capital.

In addition, in connection with the closing of the Acquisition, we issued 7,336,906 of our ordinary shares to former Zavante stockholders as initial upfront consideration. An additional 815,186 of ordinary shares will be issued to former Zavante Stockholders upon release of the holdback shares, subject to reduction in respect of certain indemnification and other obligations pursuant to the Merger Agreement.. While these shares are currently and, with respect to the holdback shares will be, restricted as a result of securities laws, following expiration of applicable holding periods, these shares will be able to be freely sold in the public market, subject to any requirements and restrictions, including any applicable volume limitations, imposed by Rule 144 under the Securities Act. In addition, the Acquisition Agreement provides that we may issue up to an additional $97.5 million in our ordinary shares to former Zavante stockholders upon the achievement of specified regulatory and commercial milestones in the future and obligates us to provide registration rights with respect to the registration for resale of such additional ordinary shares that may become issuable upon the achievement of such milestones. The issuance of our ordinary shares to satisfy the milestone payments could cause dilution to our equity holders, and the sale or resale of these shares in the public market, or the market’s expectation of such sales, may result in an immediate and substantial decline in our stock price. Such a decline would adversely affect our investors and also might make it difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

Our operations to date have been limited to organizing and staffing our company, developing and securing our technology, raising capital and undertaking preclinical studies and clinical trials of our product candidates. We have not yet demonstrated our ability to successfully complete development of any product candidates, obtain marketing approvals, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions

you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. Also, we may encounter delays or difficulties in our efforts to, or fail to, successfully integrate the operations of Zavante into our business and CONTEPO into our business strategy. Moreover, we will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

We have relied on, and expect to continue to rely on, certain government grants and funding from the Austrian government. Should these funds cease to be available, or our eligibility be reduced, or if we are required to repay any of these funds, this could impact our ongoing need for funding and the timeframes within which we currently expect additional funding will be required.

As a company that carries out extensive research and development activities, we benefit from the Austrian research and development support regime, under which we are eligible to receive a research premium from the Austrian government equal to 14% (12% for the fiscal years 2016 and 2017 and 10%, in the case of fiscal years prior to 2016) of a specified research and development cost base. Qualifying expenditures largely comprise research and development activities conducted in Austria, however, the research premium is also available for certain related third-party expenses with additional limitations. We received research premiums of $5.9 million for the year ended December 31, 2016 and $4.3 million for the year ended December 31, 2015. We have not received any research premium for our qualified 2017 expenditures as of March 31, 2018. As we increase our personnel and expand our business outside of Austria, including as a result of the Acquisition, we may not be able to continue to claim research premiums to the same extent as we have in previous years, as some research and development activities may no longer be considered to occur in Austria. As research premiums that have been paid out already may be audited by the tax authorities, there is a risk that parts of the submitted cost base may not be considered as eligible and therefore repayments may have to be made.

The intended efficiency of our corporate structure depends on the application of the tax laws and regulations in the countries where we operate, and we may have exposure to additional tax liabilities or our effective tax rate could change, which could have a material impact on our results of operations and financial position.

As a company with international operations, we are subject to income taxes, as well as non-income based taxes, in both the United States and various foreign jurisdictions. We have designed our corporate structure, the manner in which we develop and use our intellectual property, and our intercompany transactions between our subsidiaries in a way that is intended to enhance our operational and financial efficiency. The application of the tax laws and regulations of various countries in which we operate and to our global operations is subject to interpretation. We also must operate our business in a manner consistent with our corporate structure to realize such efficiencies. The tax authorities of the countries in which we operate may challenge our methodologies for valuing developed technology or for transfer pricing. If, for one or more of

these reasons, tax authorities determine that the manner in which we operate results in our business not achieving the intended tax consequences, our effective tax rate could increase and harm our financial position and results of operations.

A change in the tax law in the jurisdictions in which we do business, including an increase in tax rates, an adverse change in the treatment of an item of income or expense, a decrease in tax rates in a jurisdiction in which we have significant deferred tax assets, or a new or different interpretation of applicable tax law, could result in a material increase in tax expense.

Risks Related to Product Development and Commercialization

We depend heavily on the success of, lefamulin, which we are developing for CABP and other indications, and CONTEPO, which we are developing for cUTI, including AP. If we are unable to obtain marketing approvals for lefamulin or CONTEPO, or if thereafter we fail to commercialize lefamulin or CONTEPO or experience significant delays in doing so, our business will be materially harmed.

We have invested a significant portion of our efforts and financial resources in the development of lefamulin and, most recently, in CONTEPO in connection with the Acquisition. There remains a significant risk that we will fail to successfully develop lefamulin for CABP or any other indication or CONTEPO for cUTI.

In September 2017, we announced positive topline results for LEAP 1. Patient enrollment for LEAP 2 was completed in December 2017. In May 2018, we announced positive topline results from LEAP 2. We expect to submit a new drug application, or NDA, for marketing approval of lefamulin for the treatment of CABP in adults in the United States in the fourth quarter of 2018. We also expect to submit a marketing authorization application, or MAA, for lefamulin for the treatment of CABP in adults in Europe a few months after our NDA filing.

In July 2016, Zavante initiated the ZEUS study. In April 2017, Zavante announced positive topline results of the ZEUS study. We expect to submit an NDA for marketing approval of CONTEPO for the treatment of cUTI, including AP, in the United States in the fourth quarter of 2018. In June 2018, Zavante initiated a phase 1, non-comparative, open-label study of the pharmacokinetics and safety of a single dose of CONTEPO in pediatric subjects less than 12 years of age receiving standard-of-care antibiotic therapy for proven or suspected infection or peri-operative prophylaxis. We anticipate completing enrollment in this study in late 2020. We also intend to continue to characterize the clinical pharmacology of CONTEPO.

If we obtain marketing approval of lefamulin for CABP, or any other indication, and CONTEPO for cUTI, including AP, we also expect to incur significant additional sales, marketing, distribution and manufacturing expenses.

Our ability to generate product revenues, which may not occur for several years, if ever, will depend heavily on our obtaining marketing approval for and commercializing lefamulin and CONTEPO when and as we expect and our ability to successfully integrate Zavante into our

business and CONTEPO into our business strategy. The success of lefamulin and CONTEPO will depend on a number of factors, including the following:

· establishing and maintaining arrangements with third-party manufacturers for commercial supply and receiving regulatory approval of our manufacturing processes and our third-party manufacturers’ facilities from applicable regulatory authorities;

· receipt of marketing approvals from applicable regulatory authorities for lefamulin for the treatment of CABP and CONTEPO for the treatment of cUTI, including AP;

· launching commercial sales of lefamulin and CONTEPO, if and when approved, in collaboration with third parties;

· acceptance of lefamulin and CONTEPO, if and when approved, by patients, the medical community and third-party payors;

· effectively competing with other therapies;

· maintaining a continued acceptable safety profile of lefamulin and CONTEPO following approval;

· obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and

· protecting our rights in our intellectual property portfolio.

Successful development of lefamulin and CONTEPO for the treatment of additional indications, if any, or for use in other patient populations and our ability, if it is approved, to broaden the labels for lefamulin and CONTEPO will depend on similar factors.

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize lefamulin for CABP or for any other indications or CONTEPO for cUTI, including AP, which would materially harm our business.

If clinical trials of lefamulin, CONTEPO or any of our other product candidates fail to demonstrate safety and efficacy to the satisfaction of the U.S. Food and Drug Administration, or FDA, regulatory authorities in the European Union, or other regulatory authorities or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of lefamulin, CONTEPO or any other product candidate.

Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete preclinical development and early clinical trials, including Phase 1 clinical trials, in addition to extensive later-stage Phase 3 clinical trials, to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to

design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced or completed. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. In connection with the ZEUS study in which CONTEPO met the primary endpoint of statistical non-inferiority versus piperacillin/tazobactam, Zavante conducted a post-hoc primary efficacy analysis of CONTEPO using results of blinded pulsed-field gel electrophoresis molecular typing of urinary tract pathogens. Regulatory authorities typically give greater weight to results from pre-specified analyses and less weight to results from post-hoc, retrospective analyses. While we believe this post-hoc analysis is illustrative information, the FDA may ultimately have a different interpretation of any of our data that may be based on such post-hoc analysis. Also, in advance of our NDA submission for CONTEPO, we are required to complete a four-week Good Laboratory Practice toxicology study.

If we are required to conduct additional clinical trials or other testing or studies of lefamulin, CONTEPO or any other product candidate that we develop beyond those that we contemplate, if we are unable to successfully complete our clinical trials or other testing or studies, if the results of these trials, tests or studies are not positive or are only modestly positive, if there are safety concerns or if they are otherwise not acceptable to the FDA, we may:

· be delayed in obtaining marketing approval for our product candidates;

· need to raise capital before we otherwise would or on terms less favorable to us;

· not obtain marketing approval at all;

· obtain approval for indications or patient populations that are not as broad as intended or desired;

· obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

· be subject to additional post-marketing testing requirements or restrictions; or

· have the product removed from the market after obtaining marketing approval.

The occurrence of any of the developments listed above could materially harm our business, financial condition, results of operations and prospects.

If we experience any of a number of possible unforeseen events in connection with our clinical trials, the potential marketing approval or commercialization of lefamulin, CONTEPO or other product candidates could be delayed or prevented.

We may experience numerous unforeseen events during, or as a result of, our clinical trials of lefamulin and CONTEPO or other product candidates that could delay or prevent our ability to receive marketing approval or commercialize lefamulin, CONTEPO or our other product candidates, including:

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

· the number of patients required for clinical trials may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

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

· regulators, institutional review boards or independent ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site or may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

· we may experience delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

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

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

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

· our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators, institutional review boards or independent ethics committees to suspend or terminate the trials.

Our product development costs will increase if we experience delays in enrollment in our clinical development program or our non-clinical development program or in obtaining marketing approvals. We do not know whether any additional non-clinical tests or clinical trials

will be required, or if they will begin as planned, or if they will need to be restructured or will be completed on schedule, or at all. Significant non-clinical development program delays, including chemistry, manufacturing and control activities, or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

If we experience delays or difficulties in the enrollment of patients in our clinical trials, our receipt of necessary marketing approvals could be delayed or prevented.

We may not be able to initiate or continue clinical trials for our product candidates, including with respect to lefamulin, CONTEPO or any other product candidate that we develop, if we are unable to locate and enroll a sufficient number of eligible patients to participate in these clinical trials. Some of our competitors have ongoing clinical trials for product candidates that could be competitive with lefamulin and CONTEPO, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.

Patient enrollment is affected by other factors including:

· severity of the disease under investigation;

· eligibility criteria for the clinical trial in question;

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

· approval of other therapies to treat the disease under investigation;

· efforts to facilitate timely enrollment in clinical trials;

· patient referral practices of physicians;

· the time of year in which the trial is initiated or conducted;

· the geographic distribution of global trial sites, given the timing of pneumonia season globally, and the seasonal variation in the number of patients suffering from pneumonia, including a decline in the number of patients with CABP during the summer months;

· the ability to monitor patients adequately during and after treatment;

· proximity and availability of clinical trial sites for prospective patients;

· delays in the receipt of required regulatory approvals, or the failure to receive required regulatory approvals, in the jurisdictions in which clinical trials are expected to be conducted; and

· delays in the receipt of approvals, or the failure to receive approvals, from the relevant institutional review board or ethics committee at clinical trial sites.

Enrollment delays in our clinical trials may result in increased development costs for our product candidates, which would cause the value of the company to decline and limit our ability to obtain additional financing. Our inability to enroll a sufficient number of patients in any of our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.

If serious adverse or undesirable side effects are identified during the development of lefamulin, CONTEPO or any other product candidate that we develop, we may need to abandon or limit our development of that product candidate.

All of our product candidates are in clinical or preclinical development and their risk of failure is high. It is impossible to predict when or if any of our product candidates will prove effective or safe in humans or will receive marketing approval. If our product candidates are associated with undesirable side effects or have characteristics that are unexpected, we may need to abandon their development or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Many compounds that initially showed promise in clinical or earlier stage testing have later been found to cause side effects or other safety issues that prevented further development of the compound.

In LEAP 1, lefamulin was generally well tolerated and exhibited a similar rate of treatment-emergent adverse events to the comparator drug. However, 104 patients in the lefamulin arm of the trial reported at least one treatment-emergent adverse event and eight patients withdrew from the trial following an adverse event. Furthermore, at least 2.0% of patients in LEAP 1 who were dosed with lefamulin reported the following adverse events: hypokalemia, nausea, insomnia, infusion site pain and infusion site phlebitis. Fewer than 2.0% of trial patients dosed with lefamulin also experienced hypertension and an increase in alanine aminotransaminase, although no patients met Hy’s Law criteria, which is an indicator for severe liver damage.

In addition, lefamulin was well tolerated in our Phase 2 clinical trial for ABSSSI. No patient in the trial suffered any serious adverse events that were found to be related to lefamulin, and no patient in the trial died. Some patients experienced adverse events that were assessed by the investigator as possibly or probably related to study medication. The majority of their symptoms were mild in severity. Four patients discontinued study medication following a drug-related event, three of whom were in a lefamulin treatment group: one patient experienced events of hyperhidrosis, vomiting and headache; one patient experienced infusion site pain; and one patient experienced dyspnea.

Because the potential for mild effect on electrocardiogram, or ECG, measurements was observed in preclinical studies of lefamulin, we have continued to assess this potential in all human clinical trials of lefamulin we have conducted. In the Phase 2 clinical trial, no change in ECG measurements was considered to be of clinical significance, and no drug-related cardiovascular adverse event was reported. Both lefamulin and vancomycin treatment were

associated with a small increase in the QT interval. The QT interval is a measure of the heart’s electrical cycle, and a prolonged QT interval is a risk factor for a potential ventricular arrhythmia. In each of LEAP 1 and LEAP 2, while changes in QT that were of potential clinical concern were uncommon, one patient treated with lefamulin had an increase in absolute QT interval to greater than 500 msec.

There were no systemic adverse events of clinical concern and no drug-related serious adverse events observed in any of our completed Phase 1 clinical trials of lefamulin. In these trials, the most commonly observed adverse effects with oral administration of lefamulin were related to the gastrointestinal tract, including nausea and abdominal discomfort, while the most commonly observed adverse effects related to IV administration were related to irritation at the infusion site. In addition, lefamulin produced a transient, predictable and reproducible prolongation of the QT interval based on the maximum concentration of the drug in the blood plasma. At the doses administered in the Phase 3 clinical trials for lefamulin for CABP, we expect that the drug will not produce large effects on the QT interval that would be of clinical relevance. We did not observe any drug-related cardiac adverse events, such as increase in ectopic ventricular activity or other cardiac arrhythmia, or clinically relevant ECG findings during the conduct of any of our completed Phase 1 clinical trials. If we observe clinically relevant effects on the QT interval in our Phase 3 clinical trials of lefamulin for CABP or in any other clinical trial of lefamulin, our ability to successfully develop lefamulin for CABP or any other indication may be significantly delayed or prevented.

In the ZEUS study, the incidence of premature discontinuation from study drug was low and similar between treatment groups (6.0% in the CONTEPO treatment group compared to 3.9% in the PIP-TAZ treatment group), and the incidence of not completing the study through the last follow-up visit, which occurred on the 24 th through 28 th day after completion of seven days of treatment with the study drug, or after up to 14 days of treatment for patients with concurrent bacteremia, was 5.2% in the CONTEPO group compared to 0.9% in the PIP-TAZ group. A total of 42.1% CONTEPO patients and 32.0% PIP-TAZ patients experienced at least one treatment-emergent adverse event. Most treatment-emergent adverse events were mild or moderate in severity, and severe treatment-emergent adverse events were uncommon (2.1% of CONTEPO patients and 1.7% of PIP-TAZ patients). The most common treatment-emergent adverse events in both treatment groups were transient, asymptomatic laboratory abnormalities and gastrointestinal events. Treatment-emergent serious adverse events were uncommon in both treatment groups (2.1% of CONTEPO patients and 2.6% of PIP-TAZ patients). There were no deaths in the study and one treatment-emergent serious adverse event in each treatment group was deemed related to study drug (hypokalemia in a CONTEPO patient and renal impairment in a PIP-TAZ patient), leading to study drug discontinuation in the PIP-TAZ patient. Study drug discontinuations due to the treatment-emergent adverse events were infrequent and similar between treatment groups (3.0% of CONTEPO patients and 2.6% of PIP-TAZ patients).

The most common laboratory abnormality treatment-emergent adverse events in the ZEUS study were increases in the levels of alanine aminotransferase, or ALT, (8.6% of CONTEPO patients and 2.6% of PIP-TAZ patients) and aspartate transaminase, or AST, (7.3% of CONTEPO patients and 2.6% of PIP-TAZ patients). None of the ALT or AST elevations were symptomatic or treatment-limiting, and none of the patients met the criteria for Hy’s Law. Outside the United States, elevated liver aminotransferases are listed among undesirable effects in the labeling for IV fosfomycin.

In the ZEUS study, hypokalemia occurred in 71 of 232 (30.6%) CONTEPO patients and 29 of 230 (12.6%) PIP-TAZ patients. Most decreases in potassium levels were mild to moderate in severity. Shifts in potassium levels from normal at baseline to hypokalemia, as determined by worst post-baseline hypokalemia values, were more frequent in the CONTEPO group than the PIP-TAZ group for mild (17.7% compared to 11.3%), moderate (11.2% compared to 0.9%), and severe (1.7% compared to 0.4%) categories of hypokalemia. Hypokalemia was deemed a treatment-emergent adverse event in 6.4% of patients receiving CONTEPO and 1.3% of patients receiving PIP-TAZ, and all cases were transient and asymptomatic.

While no significant cardiac adverse events were observed in the ZEUS Study, post-baseline QT intervals calculated using Fridericia’s formula, or QTcF, of greater than 450 to less than or equal to 480 msec (baseline QTcF of less than or equal to 450 msec) occurred at a higher frequency in CONTEPO patients (7.3%) compared to PIP-TAZ patients (2.5%). In the CONTEPO arm, these results appeared to be associated with the hypokalemia associated with the salt load of the IV formulation. Only one patient in the PIP-TAZ arm had a baseline QTcF of less than or equal to 500 msec and a post-baseline QTcF of greater than 500 msec.

If we elect or are forced to suspend or terminate any clinical trial of lefamulin, CONTEPO or any other product candidates that we are developing, the commercial prospects of lefamulin, CONTEPO or such other product candidates will be harmed and our ability to generate product revenues, if at all, from lefamulin, CONTEPO or any of these other product candidates will be delayed or eliminated. In addition, a higher rate of adverse events in lefamulin or CONTEPO as compared to the standard of care, even if slight, could negatively impact commercial adoption of lefamulin or CONTEPO by physicians. Any of these occurrences could materially harm our business, financial condition, results of operations and prospects.

Even if lefamulin, CONTEPO or any other product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for lefamulin, CONTEPO or any other product candidate may be smaller than we estimate.

If lefamulin, CONTEPO or any of our other product candidates receive marketing approval, it or they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. For example, current treatments for pneumonia, including generic options, are well established in the medical community, and doctors may continue to rely on these treatments without lefamulin, CONTEPO or any of our other product candidates. In addition, our efforts to effectively communicate the differentiating characteristics and key attributes of lefamulin, CONTEPO or any of our other product candidates to clinicians and hospital pharmacies with the goal of establishing favorable formulary status for lefamulin, CONTEPO or any of our other product candidates may fail or may be less successful than we expect. If lefamulin, CONTEPO or any of our other product candidates does not achieve an adequate level of acceptance, we may not generate significant product revenues or any profits from operations. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

· the efficacy and potential advantages compared to alternative treatments;

· the ability of lefamulin, CONTEPO or any other anti-infective product candidate to limit the development of bacterial resistance in the pathogens it targets;

· the prevalence and severity of any side effects;

· the ability to offer our product candidates for sale at competitive prices, including in comparison to generic competition;

· convenience and ease of administration compared to alternative treatments;

· the willingness of the target patient population to try new therapies, physicians to prescribe these therapies and hospitals to approve the cost and use by their physicians of these therapies;

· our investment in and the strength of marketing and distribution support;

· the availability of third-party coverage and adequate reimbursement; and

· the timing of any marketing approval in relation to other product approvals.

Although we believe that the mechanism of action for pleuromutilin antibiotics may result in a low propensity for development of bacterial resistance to lefamulin or our other pleuromutilin product candidates, bacteria might nevertheless develop resistance to lefamulin or our other pleuromutilin product candidates more rapidly or to a greater degree than we anticipate. Likewise, we believe that because CONTEPO works differently than other IV antibiotics approved in the United States by inhibiting an early step in bacterial cell wall synthesis, it may have a low potential for developing bacterial resistance. If bacteria develop resistance or if lefamulin or CONTEPO is not effective against drug-resistant bacteria, the efficacy of these product candidates would decline, which would negatively affect our potential to generate revenues from these product candidates.

Our ability to negotiate, secure and maintain third-party coverage and reimbursement may be affected by political, economic and regulatory developments in the United States, the European Union and other jurisdictions. Governments continue to impose cost containment measures, and third-party payors are increasingly challenging prices charged for medicines and examining their cost effectiveness, in addition to their safety and efficacy. If the level of reimbursement is below our expectations, our revenue and gross margins would be adversely affected. Obtaining formulary approval from third-party payors can be an expensive and time-consuming process. We cannot be certain if and when we will obtain formulary approval to allow us to sell lefamulin, CONTEPO or any future product candidates into our target markets. Even if we do obtain formulary approval, third-party payors, such as government or private health care insurers, carefully review and increasingly question the coverage of, and challenge the prices charged for, drugs. These and other similar developments could significantly limit the degree of

market acceptance of lefamulin, CONTEPO or any of our other product candidates that receive marketing approval.

If we are unable to establish or maintain sales, marketing and distribution capabilities or enter into or maintain sales, marketing and distribution agreements with third parties, we may not be successful in commercializing lefamulin, CONTEPO or any other product candidate if and when they are approved.

We have only a very limited sales, marketing and distribution infrastructure, and as a company we have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved product, we must either establish an adequate sales, marketing and distribution organization or outsource these functions to third parties. If lefamulin or CONTEPO receives marketing approval, we plan to commercialize it in the United States with our own targeted hospital sales and marketing organization that we plan to expand, subject to our ability to raise additional capital. In addition, we expect to utilize a variety of types of collaboration, distribution and other marketing arrangements with one or more third parties to commercialize lefamulin in markets outside the United States. We do not intend to seek approval to commercialize CONTEPO in any markets outside the United States.

There are risks involved with establishing our own sales, marketing and distribution capabilities and entering into arrangements with third parties to perform these services. If we do not establish adequate sales, marketing and distribution capabilities prior to or in connection with the commercial launch of any of our products, such products may fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community and may fail commercially or be less successful than we expect. If the commercial launch of a product candidate for which we establish marketing and distribution capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

Factors that may inhibit our efforts to commercialize our products on our own include:

· our inability to recruit, train 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 our sales representatives at a competitive disadvantage relative to sales representatives from companies with more extensive product lines; and

· unforeseen costs and expenses associated with creating an independent sales, marketing and distribution organization.

If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenues or the profitability of these product revenues to us are likely to be lower than if we were to market, sell and distribute ourselves any products that we develop. In addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

The development and commercialization of new drug products is highly competitive. We face competition with respect to lefamulin, CONTEPO and any other products we may seek to develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

There are a variety of available therapies marketed for the treatment of CABP and cUTI. Currently the treatment of CABP and cUTI is dominated by generic products. For hospitalized patients, combination therapy is frequently used in both CABP and cUTI. Many currently approved drugs are well-established therapies and are widely accepted by physicians, patients and third-party payors for the treatment of CABP. We also are aware of various drugs under development for the treatment of CABP, including omadacycline (under Phase 3 clinical development by Paratek Pharmaceuticals Inc.), delafloxacin (under Phase 3 clinical development by Melinta Therapeutics Inc.) and oral nafithromycin (under Phase 2 clinical development by Wockhardt Ltd.). If approved, we expect CONTEPO will face competition from commercially available branded antibiotics such as ceftazidime-avibactam, meropenem-vaborbactam, tigecycline and plazomicin, from other products currently in development for the treatment of cUTI, including AP, such as imipenem-relebactam (under Phase 3 clinical development by Merck), cefiderocol (under Phase 3 clinical development by Shionogi), eravacycline (under development by Tetraphase), sulbactam-ETX2514 (under development by Entasis), and LYS228 (under development by Novartis), as well as generically available agents including carbapenems, aminoglycosides, and polymyxins.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are approved for broader indications or patient populations, are more convenient or are less expensive than any products that we may develop. Our competitors may also obtain marketing approvals for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected because in some cases insurers or other third-party payors seek to encourage the use of generic products. This may have the effect of making branded products less attractive, from a cost perspective, to buyers. We expect that if

lefamulin is approved for CABP and CONTEPO is approved for cUTI, including AP, they will be priced at a significant premium over competitive generic products. This may make it difficult for us to replace existing therapies with lefamulin and CONTEPO. The key competitive factors affecting the success of our product candidates are likely to be their efficacy, safety, convenience, price and the availability of coverage and reimbursement from government and other third-party payors.

Many of our competitors may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining approvals from regulatory authorities and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to or necessary for our programs.

Even if we are able to commercialize lefamulin, CONTEPO or any other product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval.

Our ability to commercialize lefamulin, CONTEPO or any other product candidate successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A major trend in the healthcare industries in the European Union and the United States and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular

medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that coverage and reimbursement will be available for lefamulin, CONTEPO or any other product that we commercialize and, if coverage and reimbursement are available, the level of reimbursement. Reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. Obtaining and maintaining adequate reimbursement for lefamulin and CONTEPO may be particularly difficult because of the number of generic drugs, which are typically available at lower prices, that are available to treat CABP and cUTI. In addition, third-party payors are likely to impose strict requirements for reimbursement of a higher priced drug, such as lefamulin and CONTEPO. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize lefamulin, CONTEPO or other product candidates for which we obtain marketing approval.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the applicable regulatory authority. Moreover, eligibility for coverage and reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs, and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. In the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. In the European Union, reference pricing systems and other measures may lead to cost containment and reduced prices. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and to limit commercialization of any products that we may develop or in-license.

We face an inherent risk of product liability exposure related to the testing of lefamulin, CONTEPO and any other product candidate that we develop in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop or in-license. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

· reduced resources of our management to pursue our business strategy;

· decreased demand for any product candidates or products that we may develop;

· injury to our reputation and significant negative media attention;

· withdrawal of clinical trial participants;

· significant costs to defend the related litigation;

· substantial monetary awards to trial participants or patients;

· loss of revenue; and

· the inability to commercialize any products that we may develop.

We maintain clinical trial liability insurance that covers bodily injury to patients participating in our clinical trials up to a $10.0 million annual aggregate limit and subject to a per event deductible. This amount of insurance may not be adequate to cover all liabilities that we may incur. We will need to increase our insurance coverage when and if we begin commercializing lefamulin, CONTEPO or any other product candidate that receives marketing approval. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to Our Dependence on Third Parties

Use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable quality or cost, which could delay, prevent or impair our development or commercialization efforts.

We do not own or operate manufacturing facilities for the production of lefamulin or CONTEPO that could be used in product candidate development, including clinical trial supply, or for commercial supply, or for the supply of any other compound that we are developing or evaluating in our research program. We have limited personnel with experience in drug manufacturing and lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale. We currently rely on third parties for supply of lefamulin and CONTEPO, and our strategy is to outsource all manufacturing, packaging, testing, serialization and distribution of our product candidates and products to third parties.

We have entered into agreements, and expect to enter into additional agreements, with third-party manufacturers for the long-term commercial supply of lefamulin and CONTEPO. We obtained the pleuromutilin starting material for the clinical trial supply of lefamulin from a single third-party manufacturer, Sandoz GmbH, or Sandoz, a division of Novartis AG, or Novartis. Novartis stopped manufacturing pleuromutilin for us in June 2015 and will not be a commercial supplier of pleuromutilin for us. We have identified an alternative supplier that we believe will be able to provide pleuromutilin starting material for the commercial supply of lefamulin.

However, our current operating plans do not include engaging an alternative supplier unless we obtain additional funding. Another third-party manufacturer synthesizes lefamulin from the pleuromutilin starting material and provides our supply of the active pharmaceutical ingredient. We engage separate manufacturers to provide tablets, sterile vials, and sterile diluent that we are using in our clinical trials of lefamulin.

In addition, Zavante has entered into a manufacturing and supply agreement with Ercros, S.A., pursuant to which Ercros, S.A. supplies to Zavante, on an exclusive basis, the API mixture for CONTEPO in support of filing an NDA and, if CONTEPO is approved, will supply the commercial API Mixture for CONTEPO in the United State. Zavante has also entered into a manufacturing and exclusive supply agreement with Laboratorios ERN, S.A., pursuant to which Laboratorios ERN, S.A. has agreed to supply Zavante with certain technical documentation and data as required for submission of an NDA for CONTEPO and certain regulatory support in connection with the commercial sale and use of CONTEPO in the United States. Zavante entered into a commercial packaging agreement with AndersonBrecon, Inc. for the commercial packaging of CONTEPO in addition to a manufacturing and supply agreement with Fisiopharma S.r.l. for the supply, on a minimum commitment basis, of a percentage of Zavante’s commercial requirements of CONTEPO in bulk drug vials for the United States as well as the supply of bulk drug vials of CONTEPO in connection with the submission of an NDA.

We may be unable to maintain our current arrangements for commercial supply, or conclude agreements for commercial supply with additional third-party manufacturers, or we may be unable to do so on acceptable terms. Even if we are able to establish and maintain arrangements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

· reliance on the third party for regulatory compliance and quality assurance;

· an event at one of our manufacturers or suppliers causing an unforeseen disruption of the manufacture or supply of our product candidates;

· the possible breach of the manufacturing agreement by the third party;

· the possible misappropriation of our proprietary information, including our trade secrets and know-how; and

· the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

Third-party manufacturers may not be able to comply with current good manufacturing practice, or cGMP, regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates and products.

Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

If the third parties that we engage to supply any materials or manufacture product for our non-clinical testing and clinical trials should cease to continue to do so for any reason, we likely would experience delays in advancing these trials while we identify and qualify replacement suppliers and we may be unable to obtain replacement supplies on terms that are favorable to us. For example, there are only a limited number of known manufacturers that produce the pleuromutilin starting material used in the synthesis of lefamulin. In early 2015, Novartis completed the sale of its animal health division, including its veterinary products, to a third party. As a result, we have identified an alternative supplier that currently manufactures pleuromutilin starting material for veterinary products, that we believe will be able to provide pleuromutilin starting material for the commercial scale manufacture of lefamulin. However, our current operating plans do not include engaging an alternative supplier unless we obtain additional funding. If we are not able to obtain adequate supplies of our product candidates or the drug substances used to manufacture them, it will be more difficult for us to develop our product candidates and compete effectively.

Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop product candidates and commercialize any products that receive marketing approval on a timely and competitive basis.

We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

We do not independently conduct clinical trials for our product candidates. We rely on third parties, such as contract research organizations, clinical data management organizations, medical institutions and clinical investigators, to perform this function. We expect to continue to rely on such third parties in conducting our clinical trials of lefamulin and CONTEPO, and expect to rely on these third parties to conduct clinical trials of any other product candidate that we develop. Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it would delay our product development activities.

Our reliance on these third parties for clinical development activities reduces our control over these activities but does not relieve us of our responsibilities. For example, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practices, or GCP, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a U.S. government-sponsored database, ClinicalTrials.gov, within

certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. Similar GCP and transparency requirements apply in the European Union. Failure to comply with such requirements, including with respect to clinical trials conducted outside the European Union, can also lead regulatory authorities to refuse to take into account clinical trial data submitted as part of an MAA.

Furthermore, third parties that we rely on for our clinical development activities may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates. Our product development costs will increase if we experience delays in testing or obtaining marketing approvals.

We also rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, producing additional losses and depriving us of potential product revenue.

We have entered into and may enter into additional collaborations with third parties for the development or commercialization of lefamulin, CONTEPO and our other product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.

If lefamulin and CONTEPO receive marketing approval, we plan to commercialize them in the United States with our own targeted hospital sales and marketing organization. Outside the United States, we expect to utilize a variety of types of collaboration, distribution and other marketing arrangements with one or more third parties to commercialize lefamulin. For example, we have entered into a license agreement with Sinovant pursuant to which we granted Sinovant certain rights to manufacture and commercialize lefamulin in the People’s Republic of China, Hong Kong, Macau and Taiwan. We also may seek third-party collaborators for development and commercialization of other product candidates or for lefamulin for indications other than CABP.

Our likely future collaborators for any sales, marketing, distribution, development, licensing or broader collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. Under our license agreement with Sinovant, we have, and under any such arrangements we enter into with any third parties in the future we will likely have, limited control over the amount and timing of resources that our collaborators dedicate to the development or commercialization of our product candidates. Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities and efforts to successfully perform the functions assigned to them in these arrangements.

Our current collaborations involving our product candidates pose, and any future collaborations likely will pose, numerous risks to us, including the following:

· collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected;

· collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, product and product candidate priorities, available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;

· collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

· collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

· a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products;

· collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

· collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

· disputes may arise between the collaborator and us as to the ownership of intellectual property arising during the collaboration;

· we may grant exclusive rights to our collaborators, which would prevent us from collaborating with others;

· collaborators may be unable to enforce our intellectual property rights in territories where we have licensed, or may license, them such rights, which may expose us to material adverse tax and other consequences;

· disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources; and

· collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.

For example, under our license agreement with Sinovant, if any court, tribunal or governmental agency in the People’s Republic of China, Hong Kong, Macau or Taiwan determines that the exclusive license granted to Sinovant pursuant to the license agreement is not sufficiently exclusive such that Sinovant does not have sufficient rights to enforce the licensed patent rights in such territories, we and our subsidiary, Nabriva Therapeutics GmbH, have agreed to take such commercially reasonable steps as Sinovant reasonably requests to grant Sinovant such rights. If a court in such jurisdictions were to determine that our license to Sinovant was not sufficiently exclusive and that Sinovant did not have the rights to enforce the licensed patent rights in the licensed territories, Sinovant may require us to take such actions that it deems reasonable but that we do not and which may have a material adverse effect on our business, including requiring us to make changes to our organizational structure that may result in adverse tax and other consequences, or to conduct other activities that may cause us to incur significant expenses.

Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If a collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.

If we are not able to establish additional collaborations, we may have to alter our development and commercialization plans.

The potential commercialization of lefamulin and CONTEPO and the development and potential commercialization of other product candidates will require substantial additional cash to fund expenses. For some of our product candidates, we may decide to further collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates. For example, we intend to seek to commercialize lefamulin through a variety of types of additional collaboration arrangements outside the United States.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for additional collaborations outside greater China will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator may also consider alternative product candidates

or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate. We may also be restricted under future license agreements from entering into agreements on certain terms with potential collaborators. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all. If we fail to enter into additional collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our product candidates or bring them to market and generate product revenue.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be adversely affected.

Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to our proprietary technology and products. We seek to protect our proprietary position by filing patent applications in the United States, Europe and in certain additional foreign jurisdictions related to our novel technologies and product candidates that are important to our business. This process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, if we license technology or product candidates from third parties in the future, these license agreements may not permit us to control the preparation, filing and prosecution of patent applications, or to maintain or enforce the patents, covering this intellectual property. These agreements could also give our licensors the right to enforce the licensed patents without our involvement, or to decide not to enforce the patents at all. Therefore, in these circumstances, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value

of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

The laws of foreign countries may not protect our rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. We also may not pursue or obtain patent protection in all major markets or may not obtain protection that enables us to prevent the entry of third parties onto the market. Assuming the other requirements for patentability are met, currently, the first to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in the United States, the first to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our U.S. patents or pending U.S. patent applications, or that we were the first to file for patent protection of such inventions.

Moreover, we may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, or become involved in opposition, derivation, reexamination, inter partes review, post grant review, interference proceedings or other patent office proceedings or litigation, in the United States or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or any future licensed patents by developing similar or alternative technologies or products in a non-infringing manner. In addition, other companies may attempt to circumvent any regulatory data protection or market exclusivity that we obtain under applicable legislation, which may require us to allocate significant resources to preventing such circumvention. Legal and regulatory developments in the European Union and elsewhere may also result in clinical trial data submitted as part of an MAA becoming publicly available. Such developments could enable other companies to circumvent our intellectual property rights and use our clinical trial data to obtain marketing authorizations in the European Union and in other jurisdictions. Such developments may also require us to allocate significant resources to prevent other companies from circumventing or violating our intellectual property rights. Our attempts to prevent third parties from circumventing our intellectual property and other rights may ultimately be

unsuccessful. We may also fail to take the required actions or pay the necessary fees to maintain our patents.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents, trademarks, copyrights or other intellectual property. To counter such infringement or unauthorized use, we may be required to file claims, which can be expensive and time consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference, derivation, inter partes review or post-grant review proceedings before the USPTO. The risks of being involved in such litigation and proceedings may increase as our product candidates approach commercialization, and as we gain greater visibility as a public company. Third parties may assert infringement claims against us based on existing or future intellectual property rights. We may not be aware of all such intellectual property rights potentially relating to our product candidates. Any freedom-to-operate search or analysis previously conducted may not have uncovered all relevant patents and patent applications, and there may be pending or future patent applications that, if issued, would block us from commercializing lefamulin or CONTEPO. Thus, we do not know with certainty whether

lefamulin, CONTEPO or any other product candidate, or our commercialization thereof, does not and will not infringe any third party’s intellectual property.

If we are found to infringe a third party’s intellectual property rights, or to avoid or settle litigation, we could be required to obtain a license to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us, and could require us to make substantial payments. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent or other intellectual property right. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.

Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. Litigation may be necessary to defend against these claims.

In addition, while we typically require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our business was founded as a spin-off from Sandoz. Although all patent applications are fully owned by us and were either filed by Sandoz with all rights fully transferred to us, or filed in our sole name, because we acquired certain of our patents from Sandoz, we must rely on their prior practices, with regard to the assignment of such intellectual property. Similarly, for any patent applications we acquired from Zavante in connection with the Acquisition, we must rely on Zavante’s prior practices with regard to the assignment of intellectual property. Our and their assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. For example, US patent 9,345,717 claims priority to a provisional patent application. We are in the process of perfecting ownership of that provisional application and the applications claiming priority to the provisional application in the name of Zavante. If we are not able to effect a complete transfer of right, title and interest in such applications to Zavante, ownership of the invention claimed in the ’717 patent and any other patent claiming priority to the provisional application may be subject to dispute.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to management.

Intellectual property litigation could cause us to spend substantial resources and could distract our personnel from their normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our ordinary shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development, sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for some of our technology and products, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. However, we cannot guarantee that we have executed these agreements with each party that may have or have had access to our trade secrets or that the agreements we have executed will provide adequate protection. Any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be obtained or independently developed by a competitor, our competitive position would be harmed.

We have not yet registered our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business.

Our trademark applications may not be allowed for registration, and our registered trademarks may not be maintained or enforced. During trademark registration proceedings, we

may receive rejections. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. If we do not secure registrations for our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.

Risks Related to Regulatory Approval and Marketing of Our Product Candidates and Other Legal Compliance Matters

Even if we complete the necessary non-clinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of some or all of our product candidates. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, in particular in the United States or the European Union, we will not be able to commercialize our product candidates in those markets, and our ability to generate revenue will be materially impaired.

Our product candidates, including lefamulin and CONTEPO, and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and, in the case of lefamulin, by comparable authorities in other countries. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate. We have not received approval to market lefamulin, CONTEPO or any of our other product candidates from regulatory authorities in any jurisdiction and we do not intend to seek approval to market CONTEPO outside the United States.

We have no experience in filing and supporting the applications necessary to obtain marketing approvals for product candidates and expect to rely on third-parties to assist us in this process. Securing marketing approval requires the submission of extensive non-clinical and clinical data and supporting information to various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Regulatory authorities may determine that lefamulin, CONTEPO or any of our other product candidates are not effective or only moderately effective, or have undesirable or unintended side effects, toxicities, safety profiles or other characteristics that preclude us from obtaining marketing approval or that prevent or limit commercial use.

The process of obtaining marketing approvals is expensive, may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause

delays in the approval or rejection of an application. For example, on June 23, 2016, eligible members of the electorate in the United Kingdom decided by referendum to leave the European Union, commonly referred to as Brexit. On March 29, 2017, the United Kingdom formally notified the European Union of its intention to withdraw pursuant to Article 50 of the Lisbon Treaty. Because a significant proportion of the regulatory framework in the United Kingdom is derived from European Union directives and regulations, the referendum could materially change the regulatory regime applicable to the approval of any of our product candidates in the United Kingdom. In addition, because the European Medicines Agency, or EMA, is currently located in the United Kingdom but expected to move to the Netherlands as a result of the Brexit, the implications for the regulatory review process in the European Union has not been fully clarified and could result in disruption to the EMA review process.

The FDA and comparable regulatory authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from non-clinical and clinical testing could delay, limit or prevent marketing approval of a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

Accordingly, if we or our collaborators experience delays in obtaining approval or if we or they fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenues will be materially impaired.

Our failure to obtain marketing approval in jurisdictions other than the United States and Europe would prevent our product candidates from being marketed in these other jurisdictions, and any approval we are granted for our product candidates in the United States and Europe would not assure approval of product candidates in other jurisdictions.

In order to market and sell lefamulin and our other product candidates in jurisdictions other than the United States and Europe, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval process varies among countries and can involve additional testing. The time required to obtain approval may differ from that required to obtain FDA approval or approvals from regulatory authorities in the European Union. The regulatory approval process outside the United States and Europe generally includes all of the risks associated with obtaining FDA approval or approvals from regulatory authorities in the European Union. In addition, some countries outside the United States and Europe require approval of the sales price of a drug before it can be marketed. In many countries, separate procedures must be followed to obtain reimbursement and a product may not be approved for sale in the country until it is also approved for reimbursement. We may not obtain marketing, pricing or reimbursement approvals outside the United States and Europe on a timely basis, if at all. Approval by the FDA or regulatory authorities in the European Union does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States and Europe does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA or regulatory authorities in the European Union. We may not be able to file for marketing approvals and may

not receive necessary approvals to commercialize our products in any market. Marketing approvals in countries outside the United States and Europe do not ensure pricing approvals in those countries or in any other countries, and marketing approvals and pricing approvals do not ensure that reimbursement will be obtained.

Even if we obtain marketing approvals for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we manufacture and market our products and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.

Even if marketing approval of a product candidate is granted, an approved product and its manufacturer and marketer are subject to ongoing review and extensive regulation, including the potential requirements to implement a risk evaluation and mitigation strategy or to conduct costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. We must also comply with requirements concerning advertising and promotion for any of our product candidates for which we obtain marketing approval. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, we will not be able to promote any products we develop for indications or uses for which they are not approved. In addition, manufacturers of approved products and those manufacturers’ facilities are required to comply with extensive FDA requirements including ensuring that quality control and manufacturing procedures conform to cGMP, which include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation and reporting requirements. We and our contract manufacturers could be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMP.

Accordingly, assuming we receive marketing approval for one or more of our product candidates, we and our contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we are not able to comply with post-approval regulatory requirements, we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any future products could be limited, which could adversely affect our ability to achieve or sustain profitability. Thus, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.

Any product candidate for which we obtain marketing approval will be subject to strict enforcement of post-marketing requirements and we could be subject to substantial penalties, including withdrawal of our product from the market, if we fail to comply with all regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.

Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include, but are not limited to, restrictions

governing promotion of an approved product, submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. In addition, even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval.

The FDA and other federal and state agencies, including the U.S. Department of Justice, or DOJ, closely regulate compliance with all requirements governing prescription drug products, including requirements pertaining to marketing and promotion of drugs in accordance with the provisions of the approved labeling and manufacturing of products in accordance with cGMP requirements. The FDA and DOJ impose stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market our products for their approved indications, we may be subject to enforcement action for off-label marketing. Violations of such requirements may lead to investigations alleging violations of the Food, Drug and Cosmetic Act and other statutes, including the False Claims Act and other federal and state health care fraud and abuse laws as well as state consumer protection laws.

Our failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, may yield various results, including:

· litigation involving patients taking our products;

· restrictions on such products, manufacturers or manufacturing processes;

· restrictions on the labeling or marketing of a product;

· restrictions on product distribution or use;

· requirements to conduct post-marketing studies or clinical trials;

· warning or untitled letters;

· withdrawal of the products from the market;

· refusal to approve pending applications or supplements to approved applications that we submit;

· recall of products;

· fines, restitution or disgorgement of profits or revenues;

· suspension or withdrawal of marketing approvals;

· damage to relationships with any potential collaborators;

· unfavorable press coverage and damage to our reputation;

· refusal to permit the import or export of our products;

· product seizure; or

· injunctions or the imposition of civil or criminal penalties.

Non-compliance by us or any future collaborator with regulatory requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with regulatory requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

Non-compliance with European Union requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, also can result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.

In some countries, particularly the member states of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. Also, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various European Union member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidate to other available therapies to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on prices or reimbursement levels within the country of publication and other countries. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.

The FDA’s agreement to a Special Protocol Assessment, or SPA, with respect to the study design of our first Phase 3 clinical trial of lefamulin for CABP does not guarantee any particular outcome from regulatory review, including ultimate approval, and may not lead to a faster development or regulatory review or approval process.

We reached agreement with the FDA in September 2015 on a SPA, which was later amended in April 2016, regarding the study design of our first Phase 3 clinical trial of lefamulin for the treatment of CABP. The SPA process is designed to facilitate the FDA’s review and approval of drugs by allowing the FDA to evaluate the proposed design and size of Phase 3 clinical trials that are intended to form the primary basis for determining a product candidate’s efficacy and safety. Upon specific request by a clinical trial sponsor, the FDA will evaluate the protocol and respond to a sponsor’s questions regarding, among other things, primary efficacy endpoints, trial conduct and data analysis, within 45 days of receipt of the request. The FDA ultimately assesses whether the protocol design and planned analysis of the trial are acceptable to support regulatory approval of the product candidate with respect to the effectiveness in the indication studied.

Our agreement with the FDA regarding the SPA may not lead to faster development, regulatory review or approval for lefamulin. Once the FDA and an applicant reach an agreement under the special protocol assessment process regarding the design and size of a clinical trial, the agreement generally cannot be changed after the clinical trial begins. Nevertheless, the FDA may revoke or alter a SPA under defined circumstances, such as changes in the relevant data or assumptions provided by the sponsor or the emergence of new public health concerns. A revocation or alteration in our SPA could significantly delay or prevent approval of any marketing applications we submit for lefamulin.

Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidate.

If a drug is intended for the treatment of a serious or life threatening condition and the drug demonstrates the potential to address unmet medical need for this condition, the drug sponsor may apply for FDA fast track designation. The FDA has designated each of the IV and oral formulations of lefamulin and the IV formulation of CONTEPO as a qualified infectious disease product, or QIDP, and granted fast track designations to each of these formulations of lefamulin and CONTEPO. However, neither the QIDP nor the fast track designation ensures that lefamulin or CONTEPO will receive marketing approval or that approval will be granted within any particular timeframe. We may also seek fast track designation for our other product candidates. We may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program. Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.

Priority review designation by the FDA may not lead to a faster regulatory review or approval process and, in any event, does not assure FDA approval of our product candidate.

If the FDA determines that a product candidate offers major advances in treatment or provides a treatment where no adequate therapy exists, the FDA may designate the product candidate for priority review. A priority review designation means that the FDA’s goal to review an application is six months, rather than the standard review period of ten months. Because the FDA designated each of the IV and oral formulations of lefamulin and IV formulation of

CONTEPO as a QIDP, lefamulin and CONTEPO also will receive priority review. We may also request priority review for other product candidates. The FDA has broad discretion with respect to whether or not to grant priority review status to a product candidate, so even if we believe a particular product candidate is eligible for such designation or status, the FDA may decide not to grant it. Moreover, a priority review designation does not necessarily mean a faster regulatory review process or necessarily confer any advantage with respect to approval compared to conventional FDA procedures. Receiving priority review from the FDA does not guarantee approval within the six-month review cycle or thereafter.

Designation of each of lefamulin and CONTEPO as a Qualified Infectious Disease Product does not assure FDA approval of these product candidates.

A QIDP is an antibacterial or antifungal drug intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens or certain ‘‘qualifying pathogens.’’ Upon the approval of an NDA for a drug product designated by the FDA as a QIDP, the product is granted an additional period of five years of regulatory exclusivity. Even though we have received QIDP designation for the IV and oral formulations of lefamulin and IV formulation of CONTEPO, there is no assurance that these product candidates will be approved by the FDA.

If the FDA does not conclude that our product candidates satisfy the requirements under Section 505(b)(2) of the Federal Food Drug and Cosmetics Act, or if the requirements for such product candidates under Section 505(b)(2) are not as we expect, the approval pathway for those product candidates may take longer, cost more and entail greater complications and risks than anticipated, and may not be successful.

We intend to submit an NDA for CONTEPO utilizing Section 505(b)(2) of the Food, Drug and Cosmetic Act, or the FDCA, which was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Act. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

For NDAs submitted under Section 505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act apply. In accordance with the Hatch-Waxman Act, such NDAs may be required to include certifications, known as Paragraph IV certifications, that certify any patents listed in the Orange Book publication in respect to any product referenced in the 505(b)(2) application are invalid, unenforceable and/or will not be infringed by the manufacture, use or sale of the product that is the subject of the 505(b)(2) application. Under the Hatch-Waxman Act, the holder of the NDA which the 505(b)(2) application references may file a patent infringement lawsuit after receiving notice of the Paragraph IV certification. Filing of a patent infringement lawsuit triggers a one-time automatic 30-month stay of the FDA’s ability to approve the 505(b)(2) application. Neither we nor Zavante have conducted a comprehensive freedom-to-operate review with regard to CONTEPO.

Accordingly, we may invest a significant amount of time and expense in the development of CONTEPO or any other product candidate we may develop and experience significant delays and patent litigation before such products may be commercialized, if at all. A Section 505(b)(2) application may also not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired. The FDA may also require us to perform one or more additional clinical studies or measurements to support the change from the approved product. The FDA may then approve the new formulation for all or only some of the indications sought by us. The FDA may also reject our future Section 505(b)(2) submissions and may require us to file such submissions under Section 501(b)(1) of the FDCA, which could be considerably more expensive and time consuming.

In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2) over the last few years, certain competitors and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, the FDA may be required to change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2). It is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of the new product. However, even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition. Thus, even if we are able to utilize the Section 505(b)(2) regulatory pathway, there is no guarantee this would ultimately lead to faster product development or earlier approval.

If the FDA does not conclude that CONTEPO, or any of our other product candidates for which we may utilize the 505(b)(2) pathway, satisfies the requirements for the 505(b)(2) regulatory approval pathway, or if the requirements for approval of any of our product candidates, including CONTEPO, under Section 505(b)(2) are not as we expect, the approval pathway for CONTEPO and any of our other product candidates for which we may utilize the 505(b)(2) pathway will likely take significantly longer, cost significantly more and encounter significantly greater complications and risks than anticipated, and in any case may not be successful.

Under the CURES Act and the Trump Administration’s regulatory reform initiatives, the FDA’s policies, regulations and guidance may be revised or revoked and that could prevent, limit or delay regulatory approval of our product candidates, which would impact our ability to generate revenue.

In December 2016, Cures Act was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and spur innovation, but its ultimate implementation is unclear. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. For example, certain policies of the Trump administration may impact our business and industry. Namely, the Trump administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. An under-staffed FDA could result in delays in the FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. Moreover, on January 30, 2017, President Trump issued an Executive Order, applicable to all executive agencies, including the FDA, which requires that for each notice of proposed rulemaking or final regulation to be issued in fiscal year 2017, the agency shall identify at least two existing regulations to be repealed, unless prohibited by law. These requirements are referred to as the “two-for-one” provisions. This Executive Order includes a budget neutrality provision that requires the total incremental cost of all new regulations in the 2017 fiscal year, including repealed regulations, to be no greater than zero, except in limited circumstances. For fiscal years 2018 and beyond, the Executive Order requires agencies to identify regulations to offset any incremental cost of a new regulation and approximate the total costs or savings associated with each new regulation or repealed regulation. In interim guidance issued by the Office of Information and Regulatory Affairs within the Office of Management and Budget on February 2, 2017, the administration indicates that the “two-for-one” provisions may apply not only to agency regulations, but also to significant agency guidance documents. In addition, on February 24, 2017, President Trump issued an executive order directing each affected agency to designate an agency official as a “Regulatory Reform Officer” and establish a “Regulatory Reform Task Force” to implement the two-for-one provisions and other previously issued executive orders relating to the review of federal regulations, however it is difficult to predict how these requirements will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory authority. If these executive actions impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which in the event of a violation could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates, including lefamulin and CONTEPO, for which we obtain marketing approval. Our future arrangements with healthcare providers, physicians and third-party payors may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any products for

which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

· the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation or arranging of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

· the federal False Claims Act imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment by a federal healthcare program or making a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government, with potential liability including mandatory treble damages and significant per-claim penalties, currently set at $5,500 to $11,000 per false claim;

· the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

· HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

· the federal Physician Payments Sunshine Act requires applicable manufacturers of covered products to report payments and other transfers of value to physicians and teaching hospitals, with data collection beginning in August 2013; and

· analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws and transparency statutes, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers.

Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require product manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.

If our operations are found to be in violation of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our financial results. We are developing and implementing a corporate compliance program designed to ensure that we will market and sell any future products that we successfully develop from our product candidates in compliance with all applicable laws and regulations, but we cannot guarantee that this program will protect us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Current and future legislation may increase the difficulty and cost for us and any future collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could, among other things, prevent or delay marketing approval of lefamulin, CONTEPO or any of our other product candidates, restrict or regulate post-approval activities and affect our ability, or the ability of any collaborators, to profitably sell any product candidates, including lefamulin and CONTEPO, for which we, or they, obtain marketing approval. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we, or any future collaborators, may receive for any approved products.

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA. Among the provisions of the ACA of potential importance to our business and our product candidates are the following:

· an annual, non-deductible fee on any entity that manufactures or imports specified branded prescription products and biologic agents;

· an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program;

· expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance;

· a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts (and 70% starting January 1, 2019) off negotiated prices;

· extension of manufacturers’ Medicaid rebate liability;

· expansion of eligibility criteria for Medicaid programs;

· expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

· new requirements to report certain financial arrangements with physicians and teaching hospitals;

· a new requirement to annually report product samples that manufacturers and distributors provide to physicians; and

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

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes include the Budget Control Act of 2011, which among other things, led to aggregate reductions to Medicare payments to providers of up to 2% per fiscal year that started in April 2013 and, due to subsequent legislative amendments to the statutes, will stay in effect through 2027 unless additional Congressional action is taken, and the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used. Further, there have been several recent U.S. congressional inquiries and proposed state and federal legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products.

We expect that these healthcare reforms, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product and/or the level of reimbursement physicians receive for administering any approved product we might bring to market. Reductions in reimbursement levels may negatively impact the prices we receive or the frequency with which our products are prescribed or administered. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Since enactment of the ACA, there have been numerous legal challenges and Congressional actions to repeal and replace provisions of the law. In May 2017, the U.S. House of Representatives passed legislation known as the American Health Care Act of 2017. Thereafter, the Senate Republicans introduced and then updated a bill to replace the ACA known as the Better Care Reconciliation Act of 2017. The Senate Republicans also introduced legislation to repeal the ACA without companion legislation to replace it, and a “skinny” version of the Better Care Reconciliation Act of 2017. In addition, the Senate considered proposed healthcare reform legislation known as the Graham-Cassidy bill. None of these measures was passed by the United States Senate.

With enactment of the legislation commonly referred to as the Tax Cuts and Jobs Act of 2017, which was signed by the President on December 22, 2017, Congress repealed the “individual mandate.” The repeal of this provision, which requires most Americans to carry a minimal level of health insurance, will become effective in 2019. According to the Congressional Budget Office, the repeal of the individual mandate will cause 13 million fewer Americans to be insured in 2027 and premiums in insurance markets may rise. Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so-called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices. Further, the Bipartisan Budget Act of 2018, among other things, amends the ACA, effective January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” Further, each chamber of the Congress has put forth multiple bills designed to repeal or repeal and replace portions of the ACA. Although none of these measures has been enacted by Congress to date, Congress may consider other legislation to repeal and replace elements of the ACA.

The Trump Administration has also taken executive actions to undermine or delay implementation of the ACA. In January 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. In October 2017, the President signed a second Executive Order allowing for the use of association health plans and short-term health insurance, which may provide fewer health benefits than the plans sold through the ACA exchanges. At the same time, the Administration announced that it will discontinue the payment

of cost-sharing reduction, or CSR, payments to insurance companies until Congress approves the appropriation of funds for such CSR payments. The loss of the CSR payments is expected to increase premiums on certain policies issued by qualified health plans under the ACA. A bipartisan bill to appropriate funds for CSR payments was introduced in the Senate, but the future of that bill is uncertain. Further, in July 2018 following a federal district court decision from New Mexico, the Administration announced that it would be freezing payments to insurers under the ACA to cover sicker patients until it or Congress can address the appropriate methodology for calculating and making such payments. It remains to be seen how this action will affect the implementation of the ACA.

We will continue to evaluate the effect that the ACA and its possible repeal and replacement could have on our business. It is possible that repeal and replacement initiatives, if enacted into law, could ultimately result in fewer individuals having health insurance coverage or in individuals having insurance coverage with less generous benefits. While the timing and scope of any potential future legislation to repeal and replace ACA provisions is highly uncertain in many respects, it is also possible that some of the ACA provisions that generally are not favorable for the research-based pharmaceutical industry could also be repealed along with ACA coverage expansion provisions. Accordingly, such reforms, if enacted, could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain marketing approval and may affect our overall financial condition and ability to develop commercialize product candidates.

Further, there have been several recent U.S. congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products. At the federal level, the Trump administration’s budget proposal for fiscal year 2019 contains further drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. While any proposed measures will require authorization through additional legislation to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

In addition, on May 11, 2018, the Administration issued a plan to lower drug prices. Under this blueprint for action, the Administration indicated that the Department of Health and Human

Services, or HHS, will take steps to end the gaming of regulatory and patent processes by drug makers to unfairly protect monopolies; advance biosimilars and generics to boost price competition; evaluate the inclusion of prices in drug makers’ advertisements to enhance price competition; speed access to and lower the cost of new drugs by clarifying policies for sharing information between insurers and drug makers; avoid excessive pricing by relying more on value-based pricing by expanding outcome-based payments in Medicare and Medicaid; work to give Part D plan sponsors more negotiation power with drug makers; examine which Medicare Part B drugs could be negotiated for a lower price by Part D plans, and improving the design of the Part B Competitive Acquisition Program; update Medicare’s drug-pricing dashboard to increase transparency; prohibit Part D contracts that include “gag rules” that prevent pharmacists from informing patients when they could pay less out-of-pocket by not using insurance; and require that Part D plan members be provided with an annual statement of plan payments, out-of-pocket spending, and drug price increases.

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.

Moreover, legislative and regulatory proposals have also been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical drugs. We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our drug candidates, if any, may be. In addition, increased scrutiny by the United States Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us and any future collaborators to more stringent drug labeling and post-marketing testing and other requirements.

We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, which could adversely affect our business, results of operations and financial condition.

Our operations are subject to anti-corruption laws, including the U.S. Foreign Corrupt Practices Act, or FCPA, and other anti-corruption laws that apply in countries where we do business and may do business in the future. The FCPA and these other laws generally prohibit us, our officers, and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We may in the future operate in jurisdictions that pose a high risk of potential FCPA violations, and we may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the

FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in that existing laws might be administered or interpreted.

Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United States, and authorities in the European Union, including applicable export control regulations, economic sanctions on countries and persons, customs requirements and currency exchange regulations, collectively referred to as the trade control laws.

There is no assurance that we will be effective in ensuring our compliance with all applicable anti-corruption laws, including the FCPA or other legal requirements, including trade control laws. If we are not in compliance with the FCPA and other anti-corruption laws or trade control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of the FCPA, other anti-corruption laws or trade control laws by U.S. or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations currently, and may in the future, involve the use of hazardous and flammable materials, including chemicals and medical and biological materials, and produce hazardous waste products. Even if we contract with third parties for the disposal of these materials and wastes, we cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials or disposal of hazardous wastes, we could be held liable for any resulting damages, and any liability could exceed our resources.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We also maintain a general liability program for some of the risks, but our insurance program includes limited environmental damage coverage, which has an annual aggregate coverage limit of $2.0 million.

Although we maintain an umbrella policy with an annual aggregate coverage limit of $10.0 million, which may provide some environmental coverage, we do not maintain a separate policy covering environmental damages.

In addition, we may incur substantial costs to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Our employees may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.

We are exposed to the risk of employee fraud or other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable non-U.S. regulatory authorities, provide accurate information to the FDA or comparable non-U.S. regulatory authorities, comply with manufacturing standards we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable non-U.S. regulatory authorities, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Employee misconduct could also involve the improper use of information obtained during clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws, standards or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.

We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could harm our ability to operate our business effectively.

Despite the implementation of security measures, our internal computer systems and those of third parties with which we contract are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System failures, accidents or security breaches could cause interruptions in our operations, and could result in a material disruption of our drug development programs and commercialization activities and business operations, in addition to possibly requiring substantial

expenditures of resources to remedy. The loss of clinical trial data could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and our product research, development and commercialization efforts could be delayed.

We are subject to various laws protecting the confidentiality of certain patient health information, and our failure to comply could result in penalties and reputational damage.

Certain countries in which we operate have, or are developing, laws protecting the confidentiality of certain patient health information. European Union member states and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations.

For example, the European Union General Data Protection Regulation, or the GDPR, which came into force on May 25, 2018, introduced new data protection requirements in the European Union and substantial fines for breaches of the data protection rules. The GDPR imposes strict obligations and restrictions on controllers and processors of personal data including, for example, expanded disclosures about how personal data is to be used, increased requirements pertaining to health data and pseudonymised (i.e., key-coded) data, mandatory data breach notification requirements and expanded rights for individuals over their personal data. This could affect our ability to collect, analyze and transfer personal data, including health data from clinical trials and adverse event reporting, or could cause our costs to increase, and harm our business and financial condition.

While the GDPR, as a directly effective regulation, was designed to harmonize data protection law across the European Union, it does permit member states to legislate in many areas (particularly with regard to the processing of genetic, biometric or health data), meaning that inconsistencies between different member states will still arise. European Union member states have their own regimes on medical confidentiality and national and European Union-level guidance on implementation and compliance practices is often updated or otherwise revised, which adds to the complexity of processing personal data in the European Union.

Risks Related to Employee Matters and Managing Growth

Our future success depends on our ability to attract, retain and motivate key executives and qualified personnel.

We are highly dependent on the principal members of our management and scientific teams. Although we have formal employment agreements with each of our executive officers, these agreements do not prevent our executives from terminating their employment with us at any time. In connection with the Acquisition, Mr. Schroeder succeeded Dr. Broom as our Chief Executive Officer. We do not maintain ‘‘key person’’ insurance on any of our executive officers. The unplanned loss of the services of any of these persons might impede the achievement of our research, development and commercialization objectives.

Recruiting and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel, including in the United States and Ireland where we plan to expand our physical presence, will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we cannot recruit and retain qualified personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.

We expect to expand our development, regulatory and, subject to obtaining marketing approval of lefamulin and CONTEPO, sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs, technical operations, supply chain, medical affairs and, subject to obtaining marketing approval of lefamulin and CONTEPO, sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. In addition, our growth in connection with the Acquisition, including expansion of our business operations and employees who joined us in connection with the Acquisition, will impose added responsibilities on members of our management, including the need to recruit, hire, retain, motivate and integrate additional employees and business operations.

Due to our limited financial resources and the limited experience of our management team in managing a company of our current size following the Acquisition, and with such anticipated growth, we may not be able to effectively integrate Zavante into our business and CONTEPO into our business strategy, manage the future expansion of our operations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

Risks Related to Ownership of Our Ordinary Shares

An active trading market for our ordinary shares may not be sustained .

Following the Redomiciliation Transaction, our ordinary shares began trading on the Nasdaq Global Market on June 26, 2017. Given the limited trading history of our ordinary shares, there is a risk that an active trading market for our ordinary shares will not be sustained, which could put downward pressure on the market price of our ordinary shares and thereby affect the ability of our security holders to sell their shares.

The price of our ordinary shares may be volatile and fluctuate substantially.

The trading price of our ordinary shares has been and is likely to continue to be volatile. The stock market in general and the market for smaller biopharmaceutical companies in particular have experienced significant volatility that has often been unrelated to the operating performance of particular companies. The market price for our ordinary shares may be influenced by many factors, including:

· our ability to achieve the anticipated benefits of the Acquisition and to successfully implement our proposed business strategy following the Acquisition;

· market reception to the Acquisition and the transition of our chief executive officer in connection with the Acquisition;

· the success of competitive products or technologies;

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

· regulatory delays and greater government regulation of potential products due to adverse events;

· regulatory or legal developments in the United States, the European Union and other countries;

· developments or disputes concerning patent applications, issued patents or other proprietary rights;

· the recruitment or departure of key scientific or management personnel, including any personnel changes or integration issues in connection with the Acquisition;

· the level of expenses related to any of our product candidates or clinical development programs;

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

· one of our manufacturers or suppliers could have an event which causes an unforeseen disruption of the manufacture or supply of our product candidates;

· actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

· variations in our financial results or those of companies that are perceived to be similar to us;

· changes in the structure of healthcare payment systems;

· market conditions in the pharmaceutical and biotechnology sectors;

· general economic, industry and market conditions; and

· the other factors described in this ‘‘Risk Factors’’ section.

In the past, following periods of volatility in the market price of a company’s securities, securities class-action litigation has often been instituted against that company. We also may face securities class-action litigation if we cannot obtain regulatory approvals for or if we otherwise fail to commercialize lefamulin, CONTEPO or any of our other product candidates or if our securities experience volatility for any reason. Such litigation, if instituted against us, could cause us to incur substantial costs to defend such claims and divert management’s attention and resources.

Our executive officers, directors and principal shareholders, if they choose to act together, have the ability to significantly influence most matters submitted to shareholders for approval.

Our executive officers and directors, combined with our shareholders, and their respective affiliates who owned more than 5% of our outstanding ordinary shares as of July 24, 2018 (assuming the issuance of all holdback shares under the Merger Agreement) in the aggregate, beneficially own approximately 34.5% of our share capital. As a result, if these shareholders were to choose to act together, they would be able to exercise significant control over most matters submitted to our shareholders for approval, as well as our management and affairs. For example, these persons, if they choose to act together, would have significant influence over the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets.

Our ordinary shares do not trade on any exchange outside of the United States.

Our ordinary shares are listed only in the United States on The Nasdaq Global Market, and we have no plans to list our ordinary shares in any other jurisdiction. As a result, a holder of ordinary shares outside of the United States may not be able to effect transactions in our ordinary shares as readily as the holder may if our ordinary shares were listed on an exchange in that holder’s home jurisdiction.

Substantial future sales of our ordinary shares in the public market, or the perception that these sales could occur, could cause the price of our ordinary shares to decline significantly, even if our business is doing well.

Sales of a substantial number of our ordinary shares, or the perception in the market that these sales could occur, could reduce the market price of our ordinary shares. We had 48,302,341 ordinary shares outstanding as of July 24, 2018, including the 7,336,906 ordinary shares of initial upfront consideration issued in connection with the closing of the Acquisition. To the extent any of these shares are sold into the market, particularly in substantial quantities, the market price of our ordinary shares could decline.

Future issuances of ordinary shares pursuant to our equity incentive plans could also result in a reduction in the market price of our ordinary shares. We have filed registration statements on Form S-8 registering all of the ordinary shares that we may issue under our equity compensation plans. These shares can be freely sold in the public market upon issuance and once vested, subject to volume, notice and manner of sale limitations applicable to affiliates. The majority of ordinary shares that may be issued under our equity compensation plans remain subject to vesting in tranches over a four-year period. As of March 31, 2018, an aggregate of 1,337,202 options to purchase our ordinary shares had vested and become exercisable.

In addition, in March 2018, we entered into a Controlled Equity Offering SM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co., or Cantor, pursuant to which, from time to time, we may offer and sell our ordinary shares having an aggregate offering price of up to $50 million through Cantor. As of July 24, 2018, we had issued and sold an aggregate of 4,243,096 ordinary shares under the ATM Agreement. From March 31, 2018 to the date of this filing, we issued and sold an aggregate of 725,585 ordinary shares under the ATM Agreement.

If a large number of our ordinary shares are sold in the public market after they become eligible for sale, the sales could reduce the trading price of our ordinary shares and impede our ability to raise future capital.

In connection with the closing of the Acquisition, we issued 7,336,906 of our ordinary shares to former Zavante stockholders as initial upfront consideration. A n additional 815,186 of ordinary shares will be issued to former Zavante stockholders upon release of the holdback shares, subject to reduction in respect of certain indemnification and other obligations pursuant to the Merger Agreement. While these shares are currently and, with respect to the holdback shares will be, restricted as a result of securities laws, following expiration of applicable holding periods, these shares will be able to be freely sold in the public market, subject to any requirements and restrictions, including any applicable volume limitations, imposed by Rule 144 under the Securities Act. In addition, the Acquisition Agreement provides that we may issue up to an additional $97.5 million in our ordinary shares to former Zavante stockholders upon the achievement of specified regulatory and commercial milestones in the future and obligates us to provide registration rights with respect to the registration for resale of such additional ordinary shares that may become issuable upon the achievement of such milestones. The sale or resale of these shares in the public market, or the market’s expectation of such sales, may result in an immediate and substantial decline in our stock price. Such a decline will adversely affect our investors and also might make it difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

We are an ‘‘emerging growth company’’, and the reduced disclosure requirements applicable to emerging growth companies may make our ordinary shares less attractive to investors.

We are an ‘‘emerging growth company,’’ as that term is used in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and may remain an emerging growth company until December 31, 2020 or such earlier time that we are no longer an emerging growth company. For so long as we remain an emerging growth company, we are permitted and may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:

· an exemption from compliance with the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, on the design and effectiveness of our internal controls over financial reporting;

· an exemption from compliance with any requirement that the Public Company Accounting Oversight Board may adopt regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

· reduced disclosure about the company’s executive compensation arrangements; and

· exemptions from the requirements to obtain a non-binding advisory vote on executive compensation or a shareholder approval of any golden parachute arrangements.

We may choose to take advantage of some, but not all, of the available exemptions. We may take advantage of these provisions until December 31, 2020 or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earlier to occur of: the last day of the fiscal year in which we have more than $1 billion (as may be inflation-adjusted by the SEC from time-to-time) in annual revenues; the date we qualify as a ‘‘large accelerated filer,’’ with more than $700 million in market value of our share capital held by non-affiliates; or the issuance by us of more than $1 billion of non-convertible debt over a three-year period.

We may choose to take advantage of some, but not all, of the available benefits under the JOBS Act. We cannot predict whether investors will find our ordinary shares less attractive if we rely on such exemptions. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for our ordinary shares and the market price of our ordinary shares may be more volatile.

In addition, the JOBS Act also provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this exemption and, therefore, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies that are not emerging growth companies.

We have broad discretion in the use of our funds and may not use them effectively.

We have broad discretion in the application of our available funds and could spend the funds in ways that do not improve our results of operations or enhance the value of our ordinary shares. Our failure to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our ordinary shares to decline and delay the development of our product candidates. Pending their use, we may invest funds in a manner that does not produce income or that loses value.

We incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company we incur, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of The Nasdaq Global Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations have increased our legal and financial compliance costs and make some activities more time-consuming and costly. For example, these rules and regulations have made it more expensive for us to obtain director and officer liability insurance, and if such insurance becomes prohibitively expensive, this could make it more difficult for us to attract and retain qualified members of our board.

For as long as we remain an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies as described elsewhere in this ‘‘Risk Factors’’ section. We may remain an emerging growth company until December 31, 2020, although if the market value of our share capital that is held by non-affiliates exceeds $700 million as of any June 30 before that time or if we have annual gross revenues of $1 billion or more in any fiscal year (as may be inflation adjusted by the SEC from time-to-time), we would cease to be an emerging growth company as of December 31 of the applicable year. We also would cease to be an emerging growth company if we issue more than $1 billion of non-convertible debt over a three-year period.

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, security holders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our ordinary shares.

Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection with Section 404 of the Sarbanes-Oxley Act, or Section 404, or any subsequent testing by our independent registered public accounting firm, as and when required, may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. As a larger company following the Acquisition, implementing and maintaining effective controls may require more resources, and we may encounter internal control integration difficulties. Inferior internal controls could also cause investors to lose

confidence in our reported financial information, which could have a negative effect on the trading price of our ordinary shares.

Pursuant to Section 404, we will be required to furnish a report by our management on our internal control over financial reporting. However, as an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm until we are no longer an emerging growth company. To achieve compliance with Section 404 within the prescribed period, we are engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

United States investors may have difficulty enforcing judgments against us, our directors and executive officers.

We are incorporated under the laws of Ireland, and our registered offices and a substantial portion of our assets are located outside of the United States. In addition, one of our directors is a resident of a jurisdiction other than the United States. As a result, it may not be possible to effect service of process on such person or us in the United States or to enforce judgments obtained in courts in the United States against such person or us based on civil liability provisions of the securities laws of the United States.

There is no treaty between Ireland and the United States providing for the reciprocal enforcement of judgments obtained in the other jurisdiction and Irish common law rules govern the process by which a U.S. judgment may be enforced in Ireland. The following requirements must be met as a precondition before a U.S. judgment will be eligible for enforcement in Ireland:

· the judgment must be for a definite sum;

· the judgment must be final and conclusive, and the decree must be final and enforceable in the court which pronounces it;

· the judgment must be provided by a court of competent jurisdiction, and the procedural rules of the court giving the foreign judgment must have been observed;

· the U.S. court must have had jurisdiction in relation to the particular defendant according to Irish conflict of law rules; and

· jurisdiction must be obtained by the Irish courts over judgment debtors in enforcement proceedings by service in Ireland or outside Ireland in accordance with the applicable court rules in Ireland.

Even if the above requirements have been met, an Irish court may exercise its right to refuse to enforce the U.S. judgment if the Irish court is satisfied that the judgment (1) was obtained by fraud; (2) is in contravention of Irish public policy; (3) is in breach of natural justice; or (4) is irreconcilable with an earlier judgment. By way of example, a judgment of a U.S. court of liabilities predicated upon U.S. federal securities laws may not be enforced by Irish courts on the grounds of public policy if that U.S. judgment includes an award of punitive damages. Further, an Irish court may stay proceedings if concurrent proceedings are being brought elsewhere.

We do not expect to pay dividends in the foreseeable future.

We have not paid any dividends on our ordinary shares since our incorporation. Even if future operations lead to significant levels of distributable profits, we currently intend that earnings, if any, will be reinvested in our business and that dividends will not be paid until we have an established revenue stream to support continuing dividends. If we propose to pay dividends in the future, we must do so in accordance with Irish law, which provides that distributions including dividend payments, share repurchases and redemptions be funded from “distributable reserves.” Payment of future dividends to security holders will be at the discretion of our board, after taking into account various factors including our business prospects, cash requirements, financial performance, debt covenant limitations and new product development.

We are exposed to risks related to currency exchange rates .

A significant portion of our expenses are denominated in currencies other than the U.S. dollar. Because our financial statements are presented in U.S. dollars, changes in currency exchange rates have had and could have a significant effect on our operating results. Exchange rate fluctuations between foreign currencies and the U.S. dollar create risk in several ways, including the following:

· weakening of the U.S. dollar may increase the U.S. dollar cost of overseas research and development expenses;

· strengthening of the U.S. dollar may decrease the value of our revenues denominated in other currencies;

· the exchange rates on non-U.S. dollar transactions and cash deposits can distort our financial results; and

· commercial pricing and profit margins are affected by currency fluctuations.

As a holding company, our operating results, financial condition and ability to pay dividends or other distributions are entirely dependent on funding, dividends and other distributions received from our subsidiaries, which may be subject to restrictions.

Our ability to pay dividends or other distributions and to pay our obligations in the future will depend on the level of funding, dividends and other distributions, if any, received from our subsidiaries and any new subsidiaries we establish in the future. The ability of our subsidiaries to make loans or distributions (directly or indirectly) to us may be restricted as a result of several factors, including restrictions in financing agreements and the requirements of applicable law and regulatory and fiscal or other restrictions. In particular, our subsidiaries and any new subsidiaries may be subject to laws that restrict dividend payments, authorize regulatory bodies to block or reduce the flow of funds from those subsidiaries to us, or limit or prohibit transactions with affiliates. Restrictions and regulatory action of this kind could impede access to funds that we may need to make dividend payments or to fund our own obligations.

Furthermore, we may guarantee some of the payment obligations of certain of our subsidiaries from time to time. These guarantees may require us to provide substantial funds or assets to our subsidiaries or their creditors or counterparties at a time when we are in need of liquidity to fund our own obligations.

The ownership percentage of our shareholders may be diluted in the future which could dilute the voting power or reduce the value our outstanding ordinary shares.

As with any publicly traded company, the ownership percentage of our shareholders may be diluted in the future because of equity issuances for acquisitions, capital market transactions or otherwise, including equity awards that we intend to continue to grant to our directors, officers and employees. From time to time, we may issue additional options or other share awards to our directors, officers and employees under our benefits plans.

In addition, our articles of association authorize us to issue, without the approval of our shareholders, one or more classes or series of preferred shares having such designation, powers, preferences and relative, participating, optional and other special rights, including preferences over our ordinary shares respecting dividends and distributions, as our board of directors generally may determine. The terms of one or more classes or series of preferred shares could dilute the voting power or reduce the value of our ordinary shares. Similarly, the repurchase or redemption rights or liquidation preferences we could assign to holders of preferred shares could affect the residual value of the ordinary shares. Additionally, we may issue and sell our ordinary shares under our ATM Agreement from time to time, and we may issue additional ordinary shares as contingent consideration upon the achievement of certain regulatory and commercialization milestones, subject to the terms and conditions of the Acquisition Agreement. See “—Risks Related to Ownership of our Ordinary Shares— The sale of a substantial number of ordinary shares may cause the market price of our ordinary shares to decline ”.

The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation. We are incorporated as a public limited company under Irish law.

The rights of our shareholders are governed by our memorandum and articles of association and Irish law. The rights associated with our ordinary shares are different to the rights generally associated with shares held in a U.S. corporation. Material differences between the rights of

shareholders of a U.S. corporation and the rights of our shareholders include differences with respect to, among other things, distributions, dividends, repurchases and redemptions, dividends in shares / bonus issues, the election of directors, the removal of directors, the fiduciary and statutory duties of directors, conflicts of interests of directors, the indemnification of directors and officers, limitations on director liability, the convening of annual meetings of shareholders and special shareholder meetings, notice provisions for meetings, the quorum for shareholder meetings, the adjournment of shareholder meetings, the exercise of voting rights, shareholder suits, rights of dissenting shareholders, anti-takeover measures and provisions relating to the ability to amend the articles of association.

As an Irish public limited company, certain capital structure decisions require shareholder approval, which may limit our flexibility to manage our capital structure.

Under Irish law, our board of directors may increase our authorized share capital and issue new ordinary or preferred shares up to a maximum amount equal to the authorized but unissued share capital, without shareholder approval, once authorized to do so by our articles of association or by an ordinary resolution of our shareholders. Additionally, subject to specified exceptions, Irish law grants statutory preemption rights to existing shareholders where shares are being issued for cash consideration but allows shareholders to disapply such statutory preemption rights either in our articles of association or by way of special resolution. Such disapplication can either be generally applicable or be in respect of a particular allotment of shares. Accordingly, our articles of association contain, as permitted by Irish company law, provisions authorizing our board of directors to issue new shares, and to disapply statutory preemption rights. The authorization of our board of directors to issue shares and the disapplication of statutory preemption rights must both be renewed by the shareholders at least every five years, and we cannot provide any assurance that these authorizations will always be approved, which could limit our ability to issue equity and thereby adversely affect the holders of our ordinary shares.

Irish law differs from the laws in effect in the U.S. with respect to defending unwanted takeover proposals and may give our board less ability to control negotiations with hostile offerors.

We are subject to the Irish Takeover Panel Act, 1997, Takeover Rules, 2013. Under those Irish Takeover Rules, the board is not permitted to take any action that might frustrate an offer for our ordinary shares once the board has received an approach that may lead to an offer or has reason to believe that such an offer is or may be imminent, subject to certain exceptions. Potentially frustrating actions such as (i) the issue of ordinary shares, options or convertible securities, (ii) material acquisitions or disposals, (iii) entering into contracts other than in the ordinary course of business or (iv) any action, other than seeking alternative offers, which may result in frustration of an offer, are prohibited during the course of an offer or at any earlier time during which the board has reason to believe an offer is or may be imminent. These provisions may give the board less ability to control negotiations with hostile offerors and protect the interests of holders of ordinary shares than would be the case for a corporation incorporated in a jurisdiction of the United States.

The operation of the Irish Takeover Rules may affect the ability of certain parties to acquire our ordinary shares.

Under the Irish Takeover Rules, if an acquisition of ordinary shares were to increase the aggregate holding of the acquirer and its concert parties to ordinary shares that represent 30% or more of the voting rights of a company, the acquirer and, in certain circumstances, its concert parties would be required (except with the consent of the Irish Takeover Panel) to make an offer for the outstanding ordinary shares at a price not less than the highest price paid for the ordinary shares by the acquirer or its concert parties during the previous 12 months. This requirement would also be triggered by an acquisition of ordinary shares by a person holding (together with its concert parties) ordinary shares that represent between 30% and 50% of the voting rights in the company if the effect of such acquisition were to increase that person’s percentage of the voting rights by 0.05% within a 12-month period. The Irish Takeover Rules could therefore discourage an investor from acquiring 30% or more of our outstanding ordinary shares, unless such investor was prepared to make a bid to acquire all outstanding ordinary shares.

We will be exposed to the risk of future changes in law, which could materially adversely affect us.

We are subject to Irish law. As a result, we are subject to the risk of future adverse changes in Irish law (including Irish corporate and tax law). In addition, we and our subsidiaries are also subject to the risk of future adverse changes in Austrian and U.S. law, as well as changes of law in other countries in which we and our subsidiaries operate.

Future adverse changes in law could result in our not being able to maintain a worldwide effective corporate tax rate that is competitive in our industry.

While we believe that being incorporated in Ireland should not affect our ability to maintain a worldwide effective corporate tax rate that is competitive in our industry, we cannot give any assurance as to what our effective tax rate will be because of, among other things, uncertainty regarding the tax policies of the jurisdictions where we will operate. The tax laws of Ireland, Austria, the United States, and other jurisdictions could change in the future, and such changes could cause a material change in our worldwide effective corporate tax rate. In particular, legislative action could be taken by Ireland, Austria, the United States or other jurisdictions which could override tax treaties upon which we expect to rely and adversely affect our effective tax rate. As a result, our actual effective tax rate may be materially different from our expectation.

Comprehensive tax reform legislation could adversely affect our business and financial condition.

The Tax Cuts and Jobs Act of 2017, or the Tax Act, introduced significant changes to the United States Internal Revenue Code, or Code.

The Tax Act, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, limitation of the tax deduction for interest expense, limitation of the deduction for net operating losses, one time taxation of offshore earnings at reduced rates regardless of whether they are repatriated, and modifying or repealing many business deductions and credits.

We continue to examine the impact the Tax Act may have on our business. Notwithstanding the reduction in the federal corporate income tax rate, the overall impact of the Tax Act is uncertain and our business and financial condition could be adversely affected.

After tax reform, U.S. persons who own 10 percent or more of our shares may be subject to U.S. federal income taxation on certain of our foreign subsidiaries’ income even if such income is not distributed to such U.S. persons.

A foreign corporation is treated as a “controlled foreign corporation”, or CFC, for U.S. federal income tax purposes if, on any day during a taxable year, “United States shareholders” (as defined below) own (directly, indirectly or constructively within the meaning of Section 958 of the Code) more than 50% of the total combined voting power of all classes of our voting shares or more than 50% of the total value of all of our shares. A “United States shareholder” of a foreign corporation is a U.S. person who owns (directly, indirectly or constructively within the meaning of Section 958 of the Code) at least 10% of the total combined voting power of voting shares of such non-U.S. corporation or at least 10% of the total value of shares of all classes of stock of such non-U.S. corporation.

As a result of the Tax Act, all of our non-U.S. subsidiaries will be treated as CFCs. The legislative history under the Tax Act indicates that this change was not intended to cause these non-U.S. subsidiaries to be treated as CFCs with respect to a United States shareholder that is not related to the U.S. subsidiary of the Company. However, it is not clear whether the IRS or a court would interpret the change made by the Tax Act in a manner consistent with such indicated intent.

Any United States shareholder who owns our shares (directly or indirectly within the meaning of Section 958(a) of the Code) on the last day in such taxable year must include in its gross income for U.S. federal income tax purposes its pro rata share (based on direct or indirect ownership of value) of the non-U.S. subsidiaries’ “subpart F income,” regardless of whether that income was actually distributed to such U.S. person (with certain adjustments). “Subpart F income” of a CFC generally includes among other items passive income, such as dividends, interest, annuities, net gains from sales of property that do not generate active income, net commodities gains, net foreign currency gains, passive rents and royalties.

For tax years beginning after December 31, 2017, the Tax Act also requires such United States shareholders to include in their gross income for U.S. federal income tax purposes their pro rata share of a CFC’s “global intangible low tax income”, or GILTI.” In general terms, GILTI is the net income of the CFCs (other than income already included in United States shareholders’ taxable income) that exceeds 10% of the CFCs’ bases in depreciable tangible assets. GILTI is treated in a manner similar to subpart F income.

In addition, if a U.S. person disposes of shares in a non-U.S. corporation and the U.S. person was a United States shareholder at any time when the corporation was a CFC during the five-year period ending on the date of disposition, any gain from the disposition will generally be treated as a dividend to the extent of the U.S. person’s share of the corporation’s undistributed earnings and profits that were accumulated during the period or periods that the U.S. person owned the shares while the corporation was a CFC (with certain adjustments). Also, a U.S. person may be required to comply with specified reporting requirements, regardless of the number of shares owned.

A transfer of our ordinary shares, other than a transfer effected by means of the transfer of book-entry interests in the Depository Trust Company, may be subject to Irish stamp duty.

Transfers of our ordinary shares effected by means of the transfer of book entry interests in the Depository Trust Company, or DTC, will not be subject to Irish stamp duty. However, if you hold our ordinary shares directly rather than beneficially through DTC, any transfer of your shares could be subject to Irish stamp duty (currently at the rate of 1% of the higher of the price paid or the market value of the shares acquired). Payment of Irish stamp duty is generally a legal obligation of the transferee. The potential for stamp duty could adversely affect the price of our ordinary shares.

Our ordinary shares received by means of a gift or inheritance could be subject to Irish capital acquisitions tax.

Irish capital acquisitions tax, or CAT, could apply to a gift or inheritance of our ordinary shares irrespective of the place of residence, ordinary residence or domicile of the parties. This is because our ordinary shares will be regarded as property situated in Ireland. The person who receives the gift or inheritance has primary liability for CAT. Gifts and inheritances passing between spouses are exempt from CAT. Children have a tax-free threshold of €310,000 in respect of taxable gifts or inheritances received from their parents.

We may be classified as a passive foreign investment company for our tax year ending December 31, 2018, which may result in adverse U.S. federal income tax consequence to U.S. holders.

Based on our estimated gross income and average value of our gross assets and the nature of our business, we do not believe that we were a ‘‘passive foreign investment company,’’ or PFIC, for U.S. federal income tax purposes for our tax years ended December 31, 2015, 2016 or 2017. A corporation organized outside the United States generally will be classified as a PFIC for U.S. federal income tax purposes (1) in any taxable year in which at least 75% of its gross income is passive income or on average at least 50% of the gross value of its assets is attributable to assets that produce passive income or are held for the production of passive income and (2) as to a given holder who was a holder in such year and regardless of such corporation’s income or asset composition, in any subsequent taxable year, unless certain elections are made by that holder that can discontinue that classification as to that holder, at the risk of imposing substantial tax costs to that holder. Passive income for this purpose generally includes dividends, interest, royalties, rents and gains from commodities and securities transactions. Our status in any taxable year will depend on our assets and activities in each year, and because this is a factual determination made annually after the end of each taxable year, there can be no assurance that we will not be considered a PFIC for the current taxable year or any future taxable year. The market value of our assets may be determined in large part by reference to the market price of our ordinary shares, which may fluctuate considerably given that market prices of biotechnology companies have been especially volatile. We have also not determined the extent to which the income and assets of Zavante, which will be included in the PFIC calculation following the Acquisition, may adversely affect this determination. If we were to be treated as a PFIC for the tax year ending December 31, 2018, or any other future taxable year during which a U.S. holder held our ordinary shares, however, certain adverse U.S. federal income tax consequences could apply to the U.S. holder. We currently intend to make available the information necessary to permit a U.S. holder to make a valid QEF election, which may mitigate some of the adverse U.S. federal income tax consequences that could apply to a U.S. holder of ordinary shares. However, we may choose not to provide such information at a future date.

Exhibit 99. 2

FINANCIAL STATEMENTS

Zavante Therapeutics, Inc .

Years Ended December 31, 2017 and 2016

With Report of Independent Auditors

Zavante Therapeutics, Inc.

Financial Statements

Years Ended December 31, 2017 and 2016

Contents

Report of Independent Auditors	1

Financial Statements

Balance Sheets	2
Statements of Operations and Comprehensive Loss	3
Statements of Convertible Preferred Stock and Stockholders’ Deficit	4
Statements of Cash Flows	5
Notes to Financial Statements	6

Report of Independent Auditors

To the Board of Directors

Zavante Therapeutics , Inc.

We have audited the accompanying financial statements of Zavante Therapeutics, Inc., which comprise the balance sheets as of December 31, 2017 and 2016 and the related statements of operations and comprehensive loss, convertible preferred stock and stockholders’ deficit, and cash flows for the years then ended, and the related notes to the financial statements.

Management’s Responsibility for the Financial Statements

Management is responsible for the preparation and fair presentation of these financial statements in conformity with U.S. generally accepted accounting principles; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free of material misstatement, whether due to fraud or error.

Auditor’s Responsibility

Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Opinion

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Zavante Therapeutics, Inc. at December 31, 2017 and 2016, and the results of its operations and its cash flows for the years then ended in conformity with U.S. generally accepted accounting principles.

Zavante Therapeutics, Inc.’s Ability to Continue as a Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has recurring operating losses and negative cash flows that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to this matter is also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our opinion is not modified with respect to this matter.

	/s/ Ernst & Young LLP

San Diego, California
May 18, 2018

Zavante Therapeutics, Inc.

Balance Sheets

	As of December 31,
	2017			2016
Assets
Current assets:
Cash and cash equivalents	$	17,962,660		$	25,647,484
Prepaid expenses and other	387,097			179,814
Total current assets	18,349,757			25,827,298
Property and equipment, net	38,542			49,298
Other assets	10,033			58,823
Total assets	$	18,398,332		$	25,935,419

Liabilities, Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable	$	772,073		$	2,376,499
Accrued expenses	886,693			2,883,982
Accrued compensation	663,065			486,252
Notes payable	7,790,188			—
Total current liabilities	10,112,019			5,746,733

Warrant liability	211,715			—
Total liabilities	10,323,734			5,746,733

Convertible preferred stock:
Series A convertible preferred stock, $0.0001 par value; 36,100,000 shares authorized; 35,862,714 shares issued and outstanding at December 31, 2017 and 2016; liquidation preference of $48,414,664 as of December 31, 2017	48,010,231			48,010,231
Stockholders’ deficit:
Common stock, $0.0001 par value; 51,000,000 shares authorized, 7,805,210 and 7,795,210 shares issued and outstanding as of December 31, 2017 and 2016, respectively	781			780
Additional paid-in capital	462,127			207,047
Accumulated deficit	(40,398,541		)	(28,029,372		)
Total stockholders’ deficit	(39,935,633		)	(27,821,545		)
Total liabilities, convertible preferred stock, and stockholders’ deficit	$	18,398,332		$	25,935,419

See accompanying notes.

Zavante Therapeutics, Inc.

Statements of Operations and Comprehensive Loss

	Years ended December 31,
	2017			2016
Operating expenses:
Research and development	$	8,834,324		$	16,418,420
General and administrative	3,414,492			2,804,091
Purchase of in-process research and development	—			1,500,177
Total operating expenses	12,248,816			20,722,688
Other income (expense):
Change in fair value of warrant liability	8,683			—
Interest income	73,483			99,409
Interest expense	(202,519		)	(2,878,607		)
Net loss and comprehensive loss	$	(12,369,169	)	$	(23,501,886	)

See accompanying notes.

Zavante Therapeutics, Inc.

Statements of Convertible Preferred Stock and Stockholders’ Deficit

	Series A Convertible Preferred Stock			Common Stock			Additional Paid-In			Accumulated			Total Stockholders’
	Shares	Amount		Shares	Amount		Capital			Deficit			Deficit

Balance as of December 31, 2015	—	$	—	6,800,000	$	680	$	15,909		$	(4,527,486	)	$	(4,510,897	)
Issuance of Series A convertible preferred stock at $1.35 per share for cash and conversion of notes payable, accrued interest and $2,682,847 charge for beneficial conversion feature, net of issuance costs of $404,380, in March	35,862,714	48,010,231		—	—		—			—			—
Exercise of stock options for cash	—	—		995,210	100		192,405			—			192,505
Vesting related to repurchase liability, net	—	—		—	—		(155,169		)	—			(155,169		)
Stock-based compensation	—	—		—	—		153,902			—			153,902
Net loss and comprehensive loss	—	—		—	—					(23,501,886		)	(23,501,886		)
Balance as of December 31, 2016	35,862,714	48,010,231		7,795,210	780		207,047			(28,029,372		)	(27,821,545		)
Exercise of stock options for cash	—	—		10,000	1		2,999			—			3,000
Vesting related to repurchase liability, net	—	—		—	—		55,022			—			55,022
Stock-based compensation	—	—		—	—		197,059			—			197,059
Net loss and comprehensive loss	—	—		—	—					(12,369,169		)	(12,369,169		)
Balance as of December 31, 2017	35,862,714	$	48,010,231	7,805,210	$	781	$	462,127		$	(40,398,541	)	$	(39,935,633	)

See accompanying notes.

Zavante Therapeutics, Inc.

Statements of Cash Flows

	Years ended December 31,
	2017			2016
Operating activities
Net loss	$	(12,369,169	)	$	(23,501,886	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	10,756			4,482
Noncash interest expense	—			2,872,912
Amortization of debt issuance costs and debt discount	59,377			5,673
Change in fair value of warrant liabilities	(8,683		)	—
Stock-based compensation	197,059			153,902
Changes in operating assets and liabilities:
Prepaid expenses and other	(207,283		)	(37,632		)
Accounts payable	(1,604,426		)	1,982,356
Accrued expenses and compensation	(1,765,455		)	2,640,733
Net cash used in operating activities	(15,687,824		)	(15,879,460		)

Investing activities
Capital expenditures	—			(53,780		)
Net cash used in investing activities	—			(53,780		)

Financing activities
Proceeds from the issuance of notes payable	8,000,000			—
Proceeds from issuance of Series A convertible preferred stock, net of issuance costs	—			34,595,617
Proceeds from early exercise of stock options	3,000			192,505
Net cash provided by financing activities	8,003,000			34,788,122

Net (decrease) increase in cash and cash equivalents	(7,684,824		)	18,854,882
Cash and cash equivalents at beginning of year	25,647,484			6,792,602
Cash and cash equivalents at end of year	$	17,962,660		$	25,647,484

Supplemental schedule of cash flow information
Cash paid for interest	$	111,080		$	22
Cash paid for income taxes	$	1,822		$	800

Supplemental schedule of noncash activities
Change in unvested share liability	$	55,022		$	(155,169	)
Fair value of warrant issued to Lender	$	220,398		$	—
Conversion of notes payable and accrued interest into Series A preferred stock	$	—		$	10,731,767
Issuance cost for beneficial conversion feature upon conversion of notes payable into Series A preferred stock	$	—		$	2,682,847

See accompanying notes.

Zavante Therapeutics, Inc.

Notes to Financial Statements

December 31, 2017

NOTE 1 — ORGANIZATION AND DESCRIPTION OF BUSINESS

SG Pharmaceuticals, Inc. (SGP) was incorporated in Delaware in December 2014. SGP acquired all of the outstanding shares of Zavante Therapeutics, Inc. in May 2015, and merged into Zavante Therapeutics, Inc. (post-merger, the Company) in June 2015 (see Note 4). The Company is a privately-held, clinical-stage biopharmaceutical company focused on licensing, developing and commercializing novel products that address serious unmet medical needs in the hospital. The Company’s operations are based in San Diego, California.

Liquidity, Capital Resources, and Going Concern

The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. The accompanying financial statements have been prepared on a going concern basis of accounting, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from any uncertainty related to our ability to continue as a going concern. The Company has incurred net operating losses and negative cash flows from operations since its inception and expects to incur additional losses into the foreseeable future. The Company incurred net losses of $12,369,169 and $23,501,886, and used cash in operations of $15,687,824 and $15,879,460, for the years ended December 31, 2017 and 2016, respectively. To date, the Company’s sources of cash have been primarily from the sale of equity securities and debt financings. Based on our operating plans, we believe our cash and cash equivalents may not be sufficient to fund our operations through one year following the issuance of these financial statements. As a result, there is substantial doubt about the Company’s ability to continue as a going concern for one year after the financial statements were issued. The principal payments due under the term loan have been classified as a current liability as of December 31, 2017 due to the considerations discussed above and the assessment that the material adverse change clause under the term loan is not within the Company’s control. The Company has not been notified of an event of default by the Lender as of the date of these financial statements were available to be issued.

The Company intends to seek additional capital through equity and/or debt financings, government funding or collaborations or partnerships with other entities or other sources of financing. Debt or equity financing, government funding or collaborations and partnerships with other entities may not be available on a timely basis on terms acceptable to the Company, or at all. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may be required to scale back or discontinue the advancement of product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity, or cease operations.

If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values carried on the financial statements, and creditors and stockholders may lose all or part of their investment in the Company.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 2 — BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States (GAAP). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). All adjustments considered necessary for a fair presentation have been included. These adjustments consist of normal and recurring accruals, as well as non-recurring charges.

A reclassification has been made to the prior period amount to conform to the current year presentation. For the year ended December 31, 2016, a reclassification of convertible preferred stock to present as mezzanine equity was made on the balance sheet and statement of stockholders’ deficit to conform to the current-year presentation.

Segment Reporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment operating in the United States .

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In the Company’s financial statements, estimates and assumptions relied upon are used for, but not limited to, the value of accrued clinical trial costs, measurement of fair value of equity instruments, and stock-based compensation expense. The Company evaluates its estimates and assumptions on the ongoing basis. Actual results could differ from those estimates under different assumptions or conditions.

Concentration of Credit Risk and Other Risks and Uncertainties

The Company’s cash and cash equivalents are invested in federally uninsured readily available money market accounts and deposited with one financial institution in the United States. However, management believes the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which these deposits are held and of the money market funds and other entities in which these investments are made. Additionally, the Company has established guidelines regarding the diversification of its investments and their maturities, which are designed to maintain safety and liquidity. The Company is required to maintain its primary operating and securities accounts with that financial institution as required by the loan and security agreement (see Note 6). At times, deposits in this institution may exceed the Federal Deposit Insurance Corporation (FDIC) or Securities Investors Protection Corporation (SIPC) limits.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION (CONTINUED)

Concentration of Credit Risk and Other Risks and Uncertainties (Continued)

The Company relies on third-party manufacturers for the production of its drug candidate. If the third-party manufacturers are unable to continue manufacturing the Company’s drug candidate, or if the Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet any development needs or commercial supply demand for its product, if approved by the U.S. Food and Drug Administration (the “FDA”). Since the suppliers of key components and materials must be named in a new drug application (NDA) filed with the FDA for a product, significant delays can occur if the qualification of a new supplier is required.

Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include cash in readily available checking and money market accounts. Cash equivalents are carried at cost, which approximates their fair value.

Property and Equipment

Property and equipment are carried at cost, less accumulated depreciation and amortization. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, generally five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease.

Impairment of Long-lived Assets

As required under the applicable accounting guidance, the Company periodically evaluates the original assumptions and rationale used in the establishment of the carrying value and estimated lives of all of its long-lived assets, including property and equipment. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. There were no impairments for the years ended December 31, 2017 or 2016.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION (CONTINUED)

Accrued Compensation

The Company accrues liabilities for payroll related expenses and under a discretionary employee bonus plan. The estimated compensation expense is based on progress against corporate objectives approved by the Board of Directors, compensation levels of eligible individuals, and target bonus percentage levels. The Board of Directors and the Compensation Committee of the Board of Directors review and evaluate the performance against these objectives and ultimately determine what discretionary payments are made. The Company accrued $613,950 and $450,233 for liabilities associated with the employee bonus plans as of December 31, 2017 and 2016, respectively.

Warrant Liability Accounting

The Company issued a warrant for the purchase of Series A preferred shares to the Lender in connection with the Loan and Security Agreement (see Note 6). The Company classified the warrant as a liability in accordance with authoritative guidance. The Company recorded the initial warrant liability at the fair market value as of the issuance date, with subsequent re-measurement as of each reporting period, using the Black-Scholes valuation model which includes a risk-free interest rate, expected term and volatility assumptions derived from comparable companies in the biotechnology industry whose share prices are publicly available for a sufficient period of time. The expected life of the warrant was calculated using the remaining life of the warrant. The risk-free rate is based upon U.S. Treasury securities with remaining terms similar to the expected term of the warrant being valued. Changes in fair value of the warrant liability are calculated at the end of each reporting period using the Black-Scholes pricing model and are re corded as other income (expense). The Company will continue to adjust the carrying value of the warrant for changes in the estimated fair value until the earlier of the modification, exercise or expiration of the warrant. At that time, the liabilities will be reclassified to additional paid-in capital, a component of stockholders’ deficit.

Fair Value Measurements

The fair value of assets and liabilities are based on the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company uses a fair value hierarchy with three levels of inputs, of which the first two are considered observable and the last unobservable, to measure fair value:

·	Level 1 — Quoted prices in active markets for identical assets or liabilities.
·	Level 2 — Inputs, other than Level 1, that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
·	Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION (CONTINUED)

Research and Development Costs

Research and development costs are expensed as incurred. Research and development costs include: salaries and employee-related expenses, including stock-based compensation and benefits for personnel in research and product development functions; costs associated with conducting our preclinical, development and regulatory activities, including fees paid to third-party professional consultants, service providers and our scientific, therapeutic and clinical advisory boards; costs to acquire, develop and manufacture preclinical study and clinical trial materials; costs incurred under clinical trial agreements with clinical research organizations and investigative sites; costs for laboratory supplies; payments related to licensed products and technologies; allocated facilities and information technology costs, and depreciation.

Milestone payments (see Note 4) that the Company makes in connection with in-licensed technology for a particular research and development project that have no alternative future uses (in other research and development projects or otherwise) and therefore no separate economic value are expensed as research and development costs at the time the costs are incurred. The Company currently has no in-licensed technologies that have alternative future uses in research and development projects or otherwise.

Income Taxes

The Company follows the FASB ASC 740, Income Taxes, or ASC 740, in reporting deferred income taxes. The ASC 740 requires a company to recognize deferred tax assets and liabilities for expected future income tax consequences of events that have been recognized in the Company’s financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. As of December 31, 2017, the Company’s tax years beginning from 2013 to date are subject to examination by taxing authorities.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION (CONTINUED)

Stock-Based Compensation

The Company accounts for stock-based compensation expense related to employee stock options granted by estimating the fair value on the date of grant using the Black-Scholes option pricing model. For awards subject to time-based vesting conditions, stock-based compensation expense is recognized ratably over the requisite service period of the awards. The Company accounts for stock options granted and restricted stock issuances to non-employees using the fair value approach. These option grants are subject to periodic revaluation over their vesting terms. Stock-based compensation expense for an award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is reversed.

The Company estimates the fair value of its stock option awards to employees and non-employees as of the grant date using the Black-Scholes option pricing model, which requires multiple inputs, including (a) fair market value of the underlying stock as of the grant date, (b) exercise price, (c) expected stock price volatility, (d) expected term of the award, (e) risk-free interest rate, and (f) expected dividend yield.

Fair market value of common stock: As the Company’s common stock is not listed on any established stock exchange and does not have a readily available market, the fair market value is determined by the Company’s Board with the assistance of an independent valuation.

Exercise price: The exercise price for stock options is set by the Board and represents an amount that the Company believes to be no less than the fair market value of a share of the Company’s common stock as of the grant date.

Volatility: Due to a lack of Company-specific historical volatility data, the Company estimates the expected future volatility based on historical volatility of a representative group of companies that are publicly traded. The Company selected a representative group of companies with comparable characteristics to it, including risk profiles, position within the industry, and with historical per share price information sufficient to meet the expected term of the Company’s stock-based awards.

The Company computes the historical volatility of the peer group companies using the daily closing prices for the selected companies’ shares during the most recent trading period that is equal to the expected term of the Company’s stock-based awards.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION (CONTINUED)

Stock-Based Compensation (Continued)

Expected term: Due to a lack of sufficient data for exercise history, the Company estimates the expected term of the employee stock option awards using the “simplified” method, whereby, the expected term is calculated as the arithmetic average of the weighted average vesting term and the contractual term of the option. To determine the value of stock options granted to non-employees, the Company uses the full contractual term of the award.

Risk-free interest rate: The risk-free interest rate used in the Black-Scholes model is based on the implied yield on the U.S. Treasury securities with a maturity date closest to the expected term or the arithmetic average of the two periods closest to the expected term of the associated stock option award.

Expected dividend yield: The Company has never declared or paid, and does not expect to pay dividends in the foreseeable future, therefore, the expected dividend yield is assumed to be zero.

Beneficial Conversion Feature of Convertible Notes Payable

The Company accounts for convertible notes payable in accordance with the authoritative guidance. The Beneficial Conversion Feature (“BCF”) of a convertible note is normally characterized as the convertible portion or feature of certain notes payable that provide a rate of conversion that is below market value or in-the-money when issued. The Company records a BCF related to the issuance of a convertible note when issued unless the BCF is convertible upon the occurrence of a future event outside the control of the holder. Contingent conversion features are based on future events such as a liquidation or change in control of the entity, the issuance of a subsequent round of funding, or an initial public offering. This type of feature is measured when the intrinsic value can be calculated and recorded as of the date the contingency is resolved. In March 2017, in conjunction with the Company completing a Series A convertible preferred stock (Series A preferred stock) financing (see Note 7), the Company recorded a noncash interest charge of $2,682,847 related to the BCF embedded in the converted convertible notes payable.

Comprehensive Loss

Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. For all periods presented, comprehensive loss is equal to net loss.

Recently Issued Accounting Pronouncements

In February 2016, the FASB issued ASU No. 2016-02, Leases (ASU 2016-02). The new standard establishes a right-of-use model and requires a lessee to recognize on the balance sheet a right-of-use asset and corresponding lease liability for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for non-public entities for annual periods beginning after December 15, 2019 and interim periods in fiscal years beginning after December 15, 2020. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance on its financial statements and disclosures. As discussed in Note 9, the Company’s only lease is its facility lease, which expires in July 2019. Until the current lease is extended, or a new lease is entered into, the Company is uncertain as to the impact of its pending adoption of the new standard on the Company’s financial statements.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION (CONTINUED)

Recently Issued Accounting Pronouncements (Continued)

ASU 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting provides guidance on determining changes to the terms and conditions of share-based payment awards and require an entity to apply modification accounting under Topic 718 unless all of the following conditions are met: (1) the fair value of the modified award is the same as the fair value of the original award immediately before the original award is modified. If the modification does not affect any of the inputs to the valuation technique that the entity uses to value the award, the entity is not required to estimate the value immediately before and after the modification; (2) the vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified; and (3) the classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. The amendments are effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017 and should be applied prospectively to an award modified on or after the adoption date. The Company is currently evaluating the timing and impact of adopting this new accounting standard on its financial statements.

NOTE 3 — FAIR VALUE MEASUREMENTS

The carrying values of the Company’s financial instruments such as cash and cash equivalents, prepaid expenses and other, accounts payable, and accrued expenses, and accrued compensation approximate their respective fair values because of the short-term nature of those financial instruments. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the carrying amounts of the term loan, approximate its fair value. The preferred stock warrant liability is recorded at fair value.

The fair value of cash equivalents was determined based on Level 1 inputs utilizing quoted prices in active markets. The fair value of the Company’s preferred stock warrant liability was determined based on Level 3 inputs using a valuation model with significant unobservable inputs (see Notes 2 & 6). The Company had no liabilities that are measured at fair value as of December 31, 2016. Assets and liabilities measured at fair value at December 31, 2017 and 2016 were as follows:

	As of December 31, 2017
	Level 1		Level 2		Level 3		Total
Assets
Money Market Fund	$	17,672,892	$	—	$	—	$	17,672,892
Total Assets	$	17,672,892	$	—	$	—	$	17,672,892

Liabilities
Warrant to purchase Series A preferred stock	$	—	$	—	$	211,715	$	211,715
Total Liabilities	$	—	$	—	$	211,715	$	211,715

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 3 — FAIR VALUE MEASUREMENTS (CONTINUED)

	As of December 31, 2016
	Level 1		Level 2		Level 3		Total
Assets
Money Market Fund	$	25,299,409	$	—	$	—	$	25,299,409
Total Assets	$	25,299,409	$	—	$	—	$	25,299,409

The following table reconciles liabilities measured at fair value using significant unobservable events (Level 3) for the year ended December 31, 2017:

	Warrant Liability
Balance at December 31, 2016	$	—
Additions	220,398
Payments made during period	—
Change in fair value	(8,683		)
Balance at December 31, 2017	$	211,715

NOTE 4 — COMPANY FORMATION, STOCK PURCHASE AGREEMENT AND MERGER

The pre-merger Zavante Therapeutics (ZTI), a private company, was originally incorporated in Delaware in 2013 but was unfunded and unable to commence operating activities. In February 2015, SGP paid ZTI a $100,000 exclusive option fee, which was expensed as purchased in-process research and development, to conduct due diligence on the ZTI development program. In May 2015, SGP entered into a Stock Purchase Agreement (SPA) by and among SGP and all of the individual shareholders of ZTI, for the purchase of all of the seller’s rights and title in and to all of the then outstanding shares of ZTI, on a lien free basis.

The total SPA purchase price consideration to the selling shareholders at closing was as follows: (i) $400,000 was paid in cash, and (ii) issuance of 1,420,000 shares of stock valued at $14,200, both of which were expensed as purchased in-process research and development. In addition to the closing consideration, SGP committed to paying: (a) additional milestone payments totaling up to $30,500,000. These milestones include $1,500,000 paid in April 2016 upon the closing of the Series A preferred stock financing (see Note 7), which was expensed as purchase in-process research and development, and $3,000,000 is payable upon the FDA marketing approval of any Company product in the U.S., and the remaining $26,000,000 in milestone payments depend on the commercial success of any Company products and will only apply if the Company receives a marketing approval from the FDA; and (b) single digit tiered royalties on net sales of Company products. The Company’s obligation to pay such royalties will be reduced by 50%, on a country-by-country basis, if and when a generic competitive product accounts for half of the market for such product in each country. Given the early-stage nature of the ZTI development, the Company accounted for the stock purchase agreement as an asset acquisition.

In June 2015, SGP, as the sole shareholder of ZTI, merged SGP into ZTI and the Zavante Therapeutics, Inc. became the surviving company.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 5 — BALANCE SHEET DETAILS

Prepaid Expenses and Other

Prepaid expenses and other consisted of the following:

	As of December 31,
	2017		2016

Prepaid study costs	$	—	$	91,646
Prepaid insurance	54,736		73,399
Prepaid rent	10,311		10,364
ERN reimbursable costs(1)	304,951		—
Other	17,099		4,405
Total prepaid expenses and other	$	387,097	$	179,814

(1) The Company has entered into a development arrangement with ERN, see Note 9.

Property and Equipment, net

Property and equipment, net consisted of the following:

	As of December 31,
	2017			2016

Furniture and fixtures	$	46,788		$	46,788
Office equipment	6,992			6,992
Subtotal	53,780			53,780
Less accumulated depreciation and amortization	(15,238		)	(4,482		)
Property and equipment, net	$	38,542		$	49,298

The Company maintains all of its property and equipment at the Company’s facility in San Diego. Depreciation expense was $10,756 and $4,482 for the years ended December 31, 2017 and 2016, respectively.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 5 — BALANCE SHEET DETAILS (CONTINUED)

Accrued Liabilities

	As of December 31,
	2017		2016
Accrued liabilities consisted of the following:
Accrued outsourced research and development expenses	$	598,495	$	2,616,431
Accrued outside consultants fees	62,092		63,475
Unvested share liability	118,207		173,229
Accrued interest	32,062		—
Accrued other expenses	75,837		30,847
Total accrued liabilities	$	886,693	$	2,883,982

NOTE 6 — DEBT

Convertible Notes Payable

In 2015, the Company issued $10,468,486 in 8% convertible promissory notes. In connection with the closing of the funding of Series A preferred stock in March 2016, all of the notes and accrued interest automatically converted into 9,936,790 shares of the Company’s Series A preferred stock. See Note 7.

Loan and Security Agreement

In August 2016, the Company entered into a $10 million term loan and security agreement (the Loan Agreement) with Square 1 Bank, a division of Pacific Western Bank (the Lender) to provide growth capital to the Company. As of December 31, 2017, $8 million was outstanding and $2 million was available to draw and was drawn in January 2018. The credit facility bears interest based on the greater of 5% or Prime + 1.5% (6% as of December 31, 2017), payable monthly. The terms include an interest-only period through August 2018, followed by equal monthly payments of principal and interest over the remaining 24-month term.

The loans are collateralized by substantially all the assets of the Company, excluding intellectual property, which are subject to a negative pledge. Under the Loan Agreement, the Company may be precluded from entering into certain financing and other transactions without Lender approval, including disposing of certain assets and paying dividends. Upon the occurrence of an event of default, including a Material Adverse Change (as defined in the Loan Agreement), the Lenders may declare all outstanding amounts due and payable and may foreclose on the properties securing the Loan Agreement, including its cash. As a result, there is substantial doubt about the Company’s ability to continue as a going concern. The principal payments due under the Loan Agreement have been classified as a current liability as of December 31, 2017 due to the considerations discussed in Note 1 and the assessment that the material adverse change clause under the term loan is not within the Company’s control. The Company has not been notified of an event of default by the Lender as of the date these financial statements were available to be issued.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 6 — DEBT (CONTINUED)

In April 2017, in connection with the initial funding under the Loan Agreement, the Company issued to the Lender a fully exercisable warrant to purchase 185,185 shares of the Company’s Series A preferred stock at an exercise price of $1.35 per share. The warrant expires on August 5, 2026. If the warrant has not been exercised prior to its expiration date, it will be deemed to automatically convert by “cashless” conversion. In the event that the Company is acquired, the warrant will be exercisable or deemed automatically converted, which shall be determined based upon whether the Company’s successor assumes the obligations of the warrant.

The estimated fair value of the warrant issued to Square 1 was determined on the date of issuance using the Black-Scholes option-pricing valuation model with the following assumptions:

Risk free interest rate	2.27	%
Expected warrant term	10 Years
Expected volatility of common stock	98.97	%
Expected dividend yield	0.00	%

The value determined for the warrant of $220,398 has been recorded as a debt discount, as well as to stockholders’ deficit. The debt discount is being amortized to interest expense over the remaining term of the credit facility.

The Company incurred $54,463 in loan origination costs related to the Loan Agreement. Such costs are being amortized to interest expense over the remaining term of the credit facility and are classified net of notes payable.

Future maturities of long-term debt and interest payments under the credit facility as of December 31, 2017 are:

2018	$	1,737,429
2019	4,240,287
2020	2,826,858
Total minimum payments	8,804,574
Less amounts representing interest	(804,574		)
Gross balance of outstanding debt	8,000,000
Less debt discount (1)	(174,637		)
Less origination costs	(35,174		)
Total carrying value	$	7,790,188

(1) Represents the initial fair value of the warrant to purchase Series A preferred stock issued in connection with the Loan Agreement, net of amortization.

Total interest expense incurred under the Loan Agreement for the years ended December 31, 2017 and 2016 (excluding amortization of debt discount and loan origination costs) was $143,040 and $0, respectively.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 7 — STOCKHOLDERS’ DEFICIT

Convertible Series A Preferred Stock

In March 2016, the Company completed a Series A convertible preferred stock (Series A preferred stock) financing, providing the Company with $34,999,997 in aggregate gross proceeds, net of $404,380 of issuance costs, from the issuance of 25,925,924 shares of Series A preferred stock at $1.35 per share. Included in the closing of the Series A preferred stock financing was the conversion of convertible notes payable and accrued interest of $10,731,767 for 9,936,790 shares of Series A preferred stock. Such notes converted at a 20% discount from the $1.35 Series A per share issuance price, which resulted in the recording of a $2,682,847 beneficial conversion feature noncash charge through additional paid-in capital and interest expense. In aggregate, 35,862,714 shares of Series A convertible preferred stock were issued.

The Series A preferred stock have the following characteristics:

Dividends

The holders of the preferred stock are entitled to receive non-cumulative dividends at a rate of $0.108 per share per annum. Preferred stock dividends are payable, in preference and in priority to any dividends on common stock, when and if declared by the Company’s Board of Directors. As of December 31, 2017, the Company’s Board of Directors has not declared any dividends.

Liquidation

In the event of any liquidation, dissolution, or winding up of the Company, the holders of Series A preferred stock will be entitled to receive in preference to the holders of common stock, the amount of $1.35 per share, plus declared and unpaid dividends, if any. Thereafter, any remaining assets of the Company will be distributed ratably among the holders of the common stock and preferred stock, with the preferred stock limited to $4.05 per share, based upon the number of shares of common stock held by each stockholder, treating each share of preferred stock as if it were converted into shares of common stock at the then-applicable conversion rate.

If the assets and funds available to be distributed among the holders of the Series A preferred stock shall be insufficient to permit the payment of $1.35 per share, then the entire assets and funds legally available for distribution to such holders shall be distributed ratably based on the total Series A holdings of each such holder.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 7 — STOCKHOLDERS’ DEFICIT (CONTINUED)

Conversion and Voting

The shares of Series A preferred stock are convertible into an equal number of shares of common stock, at the option of the holder, subject to certain antidilutive adjustments. Each share of Series A preferred stock is automatically converted into common stock immediately upon the earlier of: (i) the Company’s sale of its common stock in a firm commitment underwritten public offering pursuant to a registration statement under the Securities Act of 1933, as amended, in which the per share price is at least $4.05 per share (as adjusted), and the gross cash proceeds are at least $40 million, or (ii) the date specified by written consent or agreement of the holders of not less than 50% of the then outstanding shares of preferred stock.

The holders of Series A preferred stock are entitled to one vote for each share of common stock into which such Series A preferred stock could then be converted; and with respect to such vote, such holder shall have full voting rights and powers equal to the voting rights and powers of the holders of common stock. Also, the preferred stockholders have been granted certain rights with regard to the election of members of the Company’s Board of Directors and various other corporate actions.

Common Stock

In December 2014 and May 2015, in conjunction with the formation of SGP and acquisition of rights pursuant to the SPA in May 2015 (see Note 4), 6,300,000 shares of restricted common stock were issued to founders and the selling shareholders of ZTI at prices ranging from $0.0001 to $0.01 per share. At original issuance, such shares vested between 12 and 48 months. As amended, 4,595,156 shares were vested and 1,704,844 shares were unvested and subject to repurchase, at a total repurchase cost of $6,784 as of December 31, 2017. As of December 31, 2017, there was $5,644 of unrecognized compensation expense related to unvested restricted stock awards, which is expected to be recognized over the remaining weighted average vesting period of approximately 1.4 years.

In May 2015, in conjunction with the acquisition of rights pursuant to the SPA, the Company issued 1,420,000 shares of common stock to the selling shareholders at $0.01 per share, including 1,170,000 of restricted common shares to a founder that vest over 48 months. The remaining shares were not subject to vesting or repurchase.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 7 — STOCKHOLDERS’ DEFICIT (CONTINUED)

2015 Equity Incentive Plan

In August 2015, the Company adopted the Zavante Therapeutics, Inc. 2015 Equity Incentive Plan (the 2015 Plan). As amended in March 2016, the 2015 Plan provided for the issuance of incentive stock options to the Company’s employees and nonstatutory stock options and restricted stock awards, in the form of a restricted stock bonus or a restricted stock purchase right, to the Company’s employees, directors, and consultants. The original number of shares available for issuance under the 2015 Plan was 2,050,000 shares, and it was subsequently increased by 6,447,713 shares to an aggregate of 8,497,713 in March 2016. As of December 31, 2017, the Company had 5,534,750 shares available for issuance under the 2015 Plan.

The 2015 Plan allowed for an early exercise of stock options, subject to the approval of the Company’s Board of Directors. In 2017 and 2016, 10,000 and 995,210 shares were early exercised, respectively. As of December 31, 2017 and 2016, 655,162 and 1,049,059 early exercised shares remained unvested and 634,885 and 579,760 shares vested during the years ended December 31, 2017 and 2016, respectively.

The exercise price of stock options is determined by the Company’s Board of Directors and generally, options have an exercise price equal to the fair market value of a share of the Company’s common stock on the date of the grant. In the case of incentive stock options, the exercise price shall not be less than 100% of the fair market value of the Company’s common stock as of the date of the grant, and the contractual term of an option may not exceed ten years. For holders of more than 10% of the Company’s total combined voting power of all classes of stock, incentive stock options may not be granted at less than 110% of the fair market value of a share of the Company’s common stock as of the date of grant, and the contractual term of those options may not exceed five years. Options are subject to vesting schedule as determined in each individual stock option award agreement.

In September 2016, incentive option grants for the purchase of 1,200,000 common shares were issued to certain employees, directors and consultants. Such incentive option awards were to vest upon a change of control and were subject to immediate termination and forfeiture under certain circumstances. In March 2017, all such awards were terminated and forfeited.

The following table summarizes stock option activity for the years ended December 31, 2017:

	Number of Stock Options	Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)
Outstanding as of December 31, 2016	3,769,010	$	0.26
Options granted	225,000	$	0.30
Options exercised	10,000	$	0.30
Options forfeited/cancelled	1,200,000	$	0.26
Outstanding as of December 31, 2017	2,784,010	$	0.26	8.4

Vested and exercisable as of December 31, 2017	1,139,160	$	0.26	8.4
Vested and expected to vest as of December 31, 2017	2,784,010	$	0.26	8.4

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 7 — STOCKHOLDERS’ DEFICIT (CONTINUED)

	Year ended December 31, 2017
	Stock options granted to employees	Stock options granted to non-employees
Expected volatility	92.9% - 98.0%	93.6%
Expected term (years)	6.1	7.9 – 8.7
Risk-free interest rate	1.96% - 2.12%	2.22% - 2.34%
Expected dividend yield	$0	$0

	Year ended December 31, 2016
	Stock options granted to employees	Stock options granted to non-employees
Expected volatility	108.0%	98.3%
Expected term (in years)	6.1	8.7 – 9.7
Risk-free interest rate	1.27% - 1.53%	1.76% - 2.07%
Expected dividend yield	$0	$0

The following table summarizes the stock-based compensation expense by line item in the statements of operations and comprehensive loss for the year ended December 31, 2017 and 2016:

	Years ended December 31,
	2017		2016
Research and development	$	33,289	$	10,875
General and administrative	163,770		143,027
Total stock-based compensation expense	$	197,059	$	153,902

As of December 31, 2017, there was $391,217 of unrecognized compensation expense related to employee and Board of Directors member unvested stock option awards, which is expected to be recognized over the remaining weighted average vesting period of approximately 2.4 years.

Unvested Share Liability

In 2015 through 2017, certain individuals were issued restricted stock or granted the ability to early exercise their options. The shares of common stock issued from restricted stock purchases or the early exercise of unvested stock options are restricted and continue to vest over the original implied service period. The Company has the option to repurchase any unvested shares at the original purchase price upon any voluntary or involuntary termination. The cash received in exchange for exercised and unvested shares related to stock options granted is recorded as a liability for the early exercise of stock options on the balance sheets and will be transferred into stockholders’ deficit as the shares vest. As of December 31, 2017 and 2016, $118,207 and $173,229, respectively, of value related to unvested restricted stock or early exercised shares were subject to repurchase from unvested shares related to cumulative restricted purchases or early stock option exercises made through each respective date.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 7 — STOCKHOLDERS’ DEFICIT (CONTINUED)

Preferred Stock Warrant

In April 2017, the Company issued a warrant to the Lender exercisable into an aggregate of 185,185 shares of Series A preferred stock. See Note 6. As of December 31, 2017, no shares have been issued pursuant to the warrant.

Common Shares Reserved for Future Issuance

The Company’s common stock reserved for future issuance consists of the following as of December 31, 2017:

Conversion of Series A preferred stock		35,862,714
Warrants for Series A preferred stock		185,185
Stock options issued and outstanding		2,784,010
Authorized for future option grants		1,245,530
		40,077,439

NOTE 8 — INCOME TAXES

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities are shown below. A valuation allowance of $8,117,000 and $8,463,400 has been established as of December 31, 2017 and 2016, respectively, as realization of such assets does not meet the more likely than not threshold under ASC 740, Accounting for Income Taxes. The net change in the total valuation allowance for the years ended December 31, 2017 and 2016, was ($347,400) and $7,081,000, respectively.

Significant components of the Company’s deferred tax assets as of December 31, 2017 and 2016 are shown in the table below:

	As of December 31,
	2017			2016
Deferred tax assets:
Net operating loss carryforwards	$	7,525,000		$	8,316,800
Research and development credits	464,000			130,100
Stock compensation	—			14,100
Other	128,000			2,400
Total deferred tax assets before the valuation allowance	8,117,000			8,463,400
Less valuation allowance	(8,117,000		)	(8,463,400		)
Net deferred tax assets	$	—		$	—

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 8 — INCOME TAXES (CONTINUED)

The reconciliation of income taxes attributable to continuing operations computed at the statutory tax rates to income tax expense (recovery), using a 35% statutory tax rate, is as follows:

	As of December 31,
	2017			2016
Income (benefit) taxes at statutory rates	$	(4,205,000	)	$	(7,991,000	)
State income tax, net of federal benefit	(36,000		)	—
Permanent differences between book and tax	193,000			1,019,000
Research and development tax credits	(176,000		)	(109,000		)
Tax law change, rate adjustment	4,681,000			—
Change in valuation allowance	(347,000		)	7,081,000
Other	(110,000		)	—
	$	—		$	—

Due to losses incurred from inception, the Company is unable to conclude that it is more likely than not that the net deferred tax assets will be realized. Therefore, the Company has recorded a full valuation allowance against the net deferred tax assets.

As of December 31, 2017, the Company has federal net operating loss (NOL) carryforwards of approximately $35.6 million which will begin to expire in 2033 unless previously utilized. As the Company is pre revenue as of December 31, 2017, the Company has no state NOL carryforwards. At December 31, 2017, the Company has federal and California tax credit carryforwards of approximately $743,000 and $865,000, respectively. The federal research tax credit begins to expire in 2035 unless previously utilized and the California research tax credit has no expiration date.

Utilization of the NOL and research credit carryforwards might be subject to a substantial annual limitation due to ownership changes that occurred in 2015 and 2016 or that could occur in the future, as required by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Code), as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and research credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period, resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders or public groups. Since the Company’s formation, the Company has raised capital through the issuance of capital stock, which, has resulted in such an ownership change, and future ownership changes may occur.

The Company has not completed a study to assess whether an ownership change has occurred. If the Company has experienced an ownership change, utilization of the NOL or research credit carryforwards would be subject to an annual limitation under Section 382 of the Code, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term, tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in the expiration of a portion of the NOL or research credit carryforwards before utilization.

The Tax Cuts and Jobs Act (“the Act”) was enacted on December 22, 2017. The Act includes a number of changes to existing U.S. tax laws that impact the Company, most notably a reduction of the U.S. federal corporate tax rate from a maximum of 35% to a flat 21%, effective January 1, 2018. As of December 31, 2017, as a result of the rate reduction, the Company has reduced the deferred tax asset balance by $4,681,000. Due to the Company’s full valuation allowance position,

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 8 — INCOME TAXES (CONTINUED)

the Company has also reduced the valuation allowance by the same amount. This impact is considered to be a provisional amount as the Company is still analyzing certain aspects of the Act and refining our calculations. The ultimate impact may differ from this provisional amount, due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Act.

The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits. Income tax positions must meet a more likely than not recognition at the effective date to be recognized. At December 31, 2017 and 2016, the unrecognized tax benefits recorded were approximately $3.1 million and $2.1 million, respectively.

The following table summarizes the activity related to the Company’s unrecognized tax benefits:

	As of December 31,
	2017		2016
Balance at beginning of the year	$	2,131,000	$	25,000
Increases related to current year tax positions	1,021,000		2,106,000
Changes related to prior year tax positions	—		—
Balance at end of the year	$	3,152,000	$	2,131,000

In the next twelve months, we do not expect a significant change in our unrecognized tax benefits. Due to the existence of the valuation allowance, future changes in unrecognized tax benefits will not impact our effective tax rate.

The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by the United States and state jurisdictions where applicable. There are currently no pending income tax examinations. The Company’s tax years from inception in 2013 are subject to examination by the federal and state tax authorities due to the carryforward of unutilized net operating losses and research and development credits. The Company’s practice is to recognize interest and penalties related to income tax matters in income tax expense. The Company has not recognized interest or penalties since inception.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 9 — COMMITMENTS AND CONTINGENCIES

Corporate Office Lease Obligation

Effective in July 2016, the Company signed a non-cancellable three-year operating lease for its corporate office facility. The lease provides for the aggregate minimum lease payments totaling $341,223, and provides the Company an option to extend the lease at the end of the original term for a three-year period. Rent expense from the effective date through December 31, 2016 and for the year ended December 31, 2017 was $49,608 and $113,741, respectively. The Company paid the landlord a security deposit of $10,033, which is included in other assets in the balance sheet as of December 31, 2017.

As of December 31, 2017, the future minimum rent payments under the operating lease are as follows:

Years ending December 31,
2018	$	113,741
2019	64,113
Total	$	177,854

Manufacturing and Supply Agreements

In 2014, ZTI entered into: (i) a Pharmaceutical Manufacturing and Exclusive Supply Agreement with Laboratorios ERN, S.A. (ERN) for the exclusive purchase of finished Product for sale in the U.S., and (ii) a Three-Way Agreement between ERN and Ercros, S.A. (Ercros) for the supply of technical documentation, expertise and know-how for API, API Mixture and finished Product manufacturing. On July 28, 2016, the Company concurrently entered into: (i) an Amended and Restated Three-Way Agreement with ERN and Ercros, (ii) an Amended and Restated Pharmaceutical Manufacturing and Exclusive Supply Agreement, both of which allowed for removing the responsibility for ERN to provide commercial Product and allow the Company to take direct responsibility for the manufacture and supply of commercial Product with separate third-party manufacturers, and (iii) an exclusive API Mixture supply agreement with Ercros at a fixed price for the first five (5) years under the agreement. Each of the agreements provide for an initial term of 10 years with automatic renewals of two (2) years for successive terms.

The Amended and Restated Pharmaceutical Manufacturing and Exclusive Supply Agreement, as amended further through December 20, 2017, provides for: (i) ERN has development responsibilities with financial obligations not to exceed $1,000,000, (ii) a milestone payment of $100,000 to ERN triggered upon the Company’s first commercial sale, (iii) a quarterly payment to ERN for each vial sold, payable in arrears, and (iv) an indemnification payment to ERN under certain circumstances as outlined therein.

In connection with ERN’s development responsibilities, as of December 31, 2017, the Company has incurred reimbursable costs of $304,951 which are included in prepaid expenses and other. Substantially all of such reimbursable costs were collected in January 2018.

Zavante Therapeutics, Inc.

Notes to Financial Statements (continued)

NOTE 9 — COMMITMENTS AND CONTINGENCIES (CONTINUED)

In July 2016 and April 2017, the Company entered into separate manufacturing and supply agreements with Antibioticos do Brasil Ltda (ABL) and Fisiopharma S.r.l (Fisiopharma), respectively, under which each party has agreed to validate and supply commercial Product to the Company. Each agreement has an initial term of ten years with automatic renewals of one (1) year for successive terms thereafter. To the extent that both suppliers are in compliance with governing regulatory requirements for manufacturers at the time the Company commences the sale of its product, then the Company will be obligated to purchase half of its future commercial needs from each party. In connection with such agreements, the Company has engaged in certain technology transfer activities. There were no significant commitments outstanding under the ABL or Fisiopharma agreements as of December 31, 2017.

NOTE 10 — 401(K) PLAN

Effective January 1, 2016, the Company established Zavante Therapeutics, Inc. 401(k) Plan (the 401K Plan), which is a defined contribution plan covering all employees. Under this plan, employees and employer can make contributions to the 401K Plan, subject to certain limits. The Company’s employees can contribute to this plan starting on the first date of employment. There were no employer contributions to the 401K Plan in the year ended December 31, 2017 and 2016.

NOTE 11 — SUBSEQUENT EVENTS

Subsequent events are events or transactions that occur after the financial statement date, but before the financial statements are issued. The Company recognizes in the accompanying financial statements the effects of all subsequent events that provide additional evidence about conditions that existed at the date of the audit report, including the estimates inherent in the process of preparing the financial statements. The Company’s financial statements do not recognize subsequent events that provide evidence about conditions that did not exist at the balance sheet date, but arose after the financial statement date and before the financial statements are issued.

The Company evaluated the subsequent events through May 18, 2018, the date on which these financial statements were available to be issued.