Document:

Document

Exhibit 10.2

AMERICAN WATER WORKS COMPANY, INC. 
2017 OMNIBUS EQUITY COMPENSATION PLAN 
RESTRICTED STOCK UNIT GRANT 
This RESTRICTED STOCK UNIT GRANT, dated as of August 31, 2020 (the “Date of Grant”), is delivered by American Water Works Company, Inc. (the “Company”) to Adam Noble (the “Participant”). 
RECITALS 
WHEREAS, the Committee (as defined in the American Water Works Company, Inc. 2017 Omnibus Equity Compensation Plan (the “Plan”)) may grant equity awards under the Plan (each, an “Equity Award”) for shares of Common Stock of the Company, par value $0.01 per share, (the “Company Stock”); 
WHEREAS, the Committee in accordance with the Plan, has determined to grant the Participant an Equity Award in the form of restricted stock units; and 
WHEREAS, the Committee has determined that the restricted stock units granted to the Participant hereunder shall be issued under the Plan and the terms and conditions of such restricted stock units shall be memorialized in this grant (the “Grant”). 
NOW, THEREFORE, the parties to this Grant, intending to be legally bound hereby, agree as follows: 
1.Grant of Restricted Stock Units. Subject to the terms and conditions set forth in this Grant and the Plan, the Company hereby grants to the Participant 1,061 units (the “Restricted Stock Units”). Each unit (a “Unit”) shall be a phantom right and shall be equivalent to one share of Company Stock on the applicable Redemption Date (as defined below). 
2.Restricted Stock Unit Account. The Company shall establish and maintain a Restricted Stock Unit account as a bookkeeping account on its records (the “Restricted Stock Unit Account”) for the Participant and shall record in such Restricted Stock Unit Account the number of Restricted Stock Units granted to the Participant. The Participant shall not have any interest in any fund or specific assets of the Company by reason of this grant or the Restricted Stock Unit Account established for the Participant. 
3.Vesting. 
(a)Except as provided in subparagraph (c) below, the Restricted Stock Units shall vest on the following dates (each a “Service Date”), provided the Participant continues to be employed by, or providing service to, the Employer (as defined in the Plan) from the Date of Grant through the applicable Service Date:

						
	Service Date	     Units Vesting

	January 31, 2021	                1/2
	January 31, 2022	                1/2

The vesting of the Restricted Stock Units is cumulative, but shall not exceed 100% of the Units subject to the Restricted Stock Units.  If the foregoing schedule would produce fractional Units, the number of Units for which the Restricted Stock Units becomes vested on a Service Date shall be rounded down to the nearest whole Unit.  The Restricted Stock Units shall become vested with respect to 100% of the Units subject to the Restricted Stock Units on January 31, 2022, if the Participant is employed by, or providing service to, the Employer on such date. 
(b)Subject to subparagraph (c) below, if at any time prior to January 31, 2022, the Participant’s employment or service with the Employer terminates for any reason, including death or disability, then all of the unvested Restricted Stock Units shall be immediately forfeited and the Participant shall not have any rights with respect to the vesting or the redemption of any portion of the Restricted Stock Unit.
(c)If at any time prior to January 31, 2022, but while the Participant is employed by or providing service to the Employer, a Change of Control (as defined below) occurs, the Company is not the surviving corporation (or survives only as a subsidiary of another corporation or entity (the “surviving corporation”)) and the Restricted Stock Units are not converted to similar grants of the surviving corporation (or a parent or subsidiary of the surviving corporation), then the portion of the Restricted Stock Units that have not yet vested as provided in subparagraph 3(a) above shall become fully vested on the date of the Change of Control (the “Change of Control Date”). In the event the Participant’s Restricted Stock Units are assumed by the surviving corporation but the Participant ceases to be employed by, or providing service to, the surviving corporation (or a parent or subsidiary of the surviving corporation) within twelve (12) months after the date of the Change of Control on account of (i) a termination of such Participant’s employment by the surviving corporation (or a parent of subsidiary of the surviving corporation) for any reason other than on account of Cause (as defined below), or on account of death or Disability (each as defined in the Plan), or (ii) a termination of employment or service by the Participant for Good Reason (as defined in the Plan), then the portion of the Restricted Stock Units that have not yet vested as provided in subparagraph 3(a) above shall become fully vested on the date of such termination of employment or service (the “Termination Date”).  For purposes of this Grant, “Change of Control” shall mean as such term is defined in the Plan, except that a Change of Control shall not be deemed to have occurred for purposes of this Agreement unless the event constituting the Change of Control constitutes 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, within the meaning of section 409A of the Internal Revenue Code of 1986, as amended (the “Code”) and its corresponding regulations.  For the avoidance of doubt, if the Change of Control does not constitute a permitted change in control event under section 409A of the Code, then the Restricted Stock Unit shall not vest on the occurrence of the Change of Control. For purposes of this Grant, “Cause” shall mean a finding by the Committee that the 
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Participant (i) has breached his or her employment or service contract with the Employer, if any; (ii) has engaged in disloyalty to the Employer including, without limitation, fraud, embezzlement, theft, commission of a felony or proven dishonesty; (iii) has disclosed trade secrets or confidential information of the Employer to persons not entitled to receive such information; (iv) has breached any written noncompetition or nonsolicitation agreement between the Participant and the Employer; or (v) has engaged in such other behavior detrimental to the interests of the Employer as the Committee determines.
4.Redemption. Unless an election is made pursuant to Paragraph 5 below, the Restricted Stock Units that have become vested pursuant to Paragraph 3 shall be redeemed by the Company on the earliest of the (i) applicable Service Date, (ii) the Change of Control Date or (iii) the Termination Date, (the date of redemption is hereinafter referred to as the “Redemption Date”).  As soon as administratively practicable following the applicable Redemption Date, but not later than forty-five (45) days following the Redemption Date, (or, if applicable, the Deferred Date, as defined in Paragraph 5 below), all Restricted Stock Units that become vested pursuant to Paragraph 3 above shall be redeemed and converted to an equivalent number of shares of Company Stock, and the Participant shall receive a single distribution of such shares of Company Stock, which shall be issued under the Plan.  
5.Deferrals. The Participant may make an irrevocable election to defer the Redemption Date (or further defer the Deferred Date (as defined below), if applicable) of any of the Restricted Stock Units that vest, plus dividend equivalents earned on such Restricted Stock Units as described in Paragraph 6 below, to a later date, provided that, except as to any election made by the Participant to accelerate the Deferred Date in the event of his or her death prior to the Deferred Date, (a) the election shall not take effect until at least twelve (12) months after the date on which the election is made, (b) the new Redemption Date cannot be earlier than five (5) years from the original Redemption Date under Paragraph 4 above (or five (5) years from the previously applicable Deferred Date, if a subsequent deferral of a Deferred Date is being made), and (c) the election must be made no less than twelve (12) months prior to the date of the Redemption Date (twelve (12) months prior to the previously applicable Deferred Date, if a subsequent deferral of a Deferred Date is being made). To defer the Redemption Date, the Participant must complete the deferral election form provided to the Participant, and return such form to the Company in the manner and by the deadline provided therein.  If the Participant desires to make a further deferral, the Participant must make such election on a separate form provided for such purpose.  Any such election shall be made in accordance with section 409A of the Code and any corresponding guidance and regulations issued under section 409A of the Code.  Notwithstanding a Participant’s election pursuant to this Paragraph, if the Change of Control Date or the Termination Date occurs prior to the Deferred Date, the redemption of the Participant’s Restricted Stock Units, plus corresponding dividend equivalents, will be the Change of Control Date or the Termination Date, as applicable.  If a Redemption Date is delayed one or more times pursuant to any election made by the Participant pursuant to this Paragraph 5, the new Redemption Date shall be referred to as the “Deferred Date.” 
6.Dividend Equivalents. Until the Redemption Date (or the Deferred Date, if elected), if any dividends are paid with respect to the shares of Company Stock, the Company shall credit to a dividend equivalent account (the “Dividend Equivalent Account”) the value of the dividends 
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that would have been distributed if the Restricted Stock Units credited to the Participant’s Restricted Stock Unit Account as of the date of payment of any such dividend were shares of Company Stock. On the Redemption Date (or the Deferred Date, if applicable), the Company shall pay to the Participant in a lump sum cash equal to the value of the dividends credited to the Participant’s Dividend Equivalent Account; provided, however, that any dividends that were credited to the Participant’s Dividend Equivalent Account that are attributable to Units that have been forfeited as provided in Paragraph 3 above shall be immediately forfeited and not payable to the Participant. No interest shall accrue on any dividend equivalents credited to the Participant’s Dividend Equivalent Account.  
7.Change of Control.  Except as set forth in Paragraph 3(c) of this Grant, the provisions set forth in the Plan applicable to a Change of Control (as defined in the Plan) shall apply to the Restricted Stock Units, and, in the event of a Change of Control, the Committee may take such actions as it deems appropriate pursuant to the Plan and is consistent with the requirements of section 409A of the Code. 
8.Acknowledgment by Participant. By accepting this Grant, the Participant acknowledges that with respect to any right to redemption or distribution pursuant to this Grant, the Participant is and shall be an unsecured general creditor of the Company without any preference as against other unsecured general creditors of the Company, and the Participant hereby covenants for himself or herself, and anyone at any time claiming through or under the Participant not to claim any such preference, and hereby disclaims and waives any such preference which may at any time be at issue, to the fullest extent permitted by applicable law. 
9.Restrictions on Issuance or Transfer of Shares of Company Stock. 
(a)To the extent permitted by Code section 409A, the obligation of the Company to deliver shares of Company Stock upon the redemption of the Restricted Stock Units shall be subject to the condition that shares of Company Stock be qualified for listing on the New York Stock Exchange or another securities exchange and be registered under the Securities Act of 1933, as amended, and that any consent or approval of any governmental regulatory body that is necessary to issue shares of Company Stock has been so obtained, and that shares of Company Stock may not be issued in whole or in part unless such listing, registration, qualification, consent or approval shall have been effected or obtained free of any conditions not acceptable to the Committee.  
(b)The issuance of shares of Company Stock and the payment of cash to the Participant pursuant to this Grant is subject to any applicable taxes and other laws or regulations of the United States or of any state having jurisdiction thereof. 

(c)As a condition to receive any shares of Company Stock on the Redemption Date (or the Deferred Date, if applicable), the Participant agrees:

(i)to be bound by, and to comply with, the Company’s policies and practices (as they may be in effect from time to time) regarding the restrictions or limitations on the transfer of such shares, and understands that the Participant may be restricted or 
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prohibited at any time and from time to time from selling, transferring, pledging, donating, assigning, margining, mortgaging, hypothecating or otherwise encumbering the shares in accordance with such policies and practices, including without limitation the Company’s Insider Trading and Prohibited Transactions Policy and the Personal Securities Trading and Preclearance Practice; and

(ii)that the shares of Company Stock obtained by the Participant upon the redemption of the Restricted Stock Units shall be subject to the guidelines and restrictions set forth in the Company’s Executive Stock Ownership Guidelines and Executive Stock Retention Requirements, effective as of July 26, 2019 (and as they may be amended, restated, supplemented and interpreted), and any applicable clawback or recoupment policies and other policies that may be implemented by the Company’s Board of Directors or a duly authorized committee thereof, from time to time.
10.Participant Undertaking.  The Participant agrees to take whatever additional actions and execute whatever additional documents the Company may deem necessary or advisable in order to carry out or effect one or more of the obligations or restrictions imposed on the Participant pursuant to the provisions of this Grant.  
11.Grant Subject to Plan Provisions. This Grant is made pursuant to the Plan, the terms of which are incorporated herein by reference, and in all respects shall be interpreted in accordance with the Plan. In the event of any contradiction, distinction or difference between this Grant and the terms of the Plan, the terms of the Plan will control. Except as otherwise defined in this Grant, capitalized terms used in this Grant shall have the meanings set forth in the Plan. This Grant is subject to the interpretations, regulations and determinations concerning the Plan established from time to time by the Committee in accordance with the provisions of the Plan, including, but not limited to, provisions pertaining to (a) rights and obligations with respect to withholding taxes, (b) the registration, qualification or listing of the shares of Company Stock, (c) changes in capitalization of the Company, and (d) other requirements of applicable law. The Committee shall have the authority to interpret and construe this Grant pursuant to the terms of the Plan, its decisions shall be conclusive as to any questions arising hereunder. By accepting this Grant, the Participant agrees (i) to be bound by the terms of the Plan and this Grant, (ii) to be bound by the determinations and decisions of the Committee with respect to this Grant, the Plan and the Participant’s rights to benefits under this Grant and the Plan, and (iii) that all such determinations and decisions of the Committee shall be binding on the Participant, his or her beneficiaries and any other person having or claiming an interest under this Grant and the Plan on behalf of the Participant.
12.No Rights as Stockholder. The Participant shall not have any rights as a stockholder of the Company, including the right to any cash dividends (except with respect to the dividend equivalent rights provided in Paragraph 6), or the right to vote, with respect to any Restricted Stock Units. 
13.No Rights to Continued Employment or Service. This Grant shall not confer upon the Participant any right to be retained in the employment or service of the Employer and shall not interfere in any way with the right of the Employer to terminate the Participant’s employment or 
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service at any time. The right of the Employer to terminate at will the Participant’s employment or service at any time for any reason is specifically reserved. 
14.Assignment and Transfers. No Restricted Stock Units or dividend equivalents awarded to the Participant under this Grant may be transferred, assigned, pledged, or encumbered by the Participant and a Restricted Stock Unit shall be redeemed and a dividend equivalent distributed during the lifetime of the Participant only for the benefit of the Participant. Any attempt to transfer, assign, pledge, or encumber the Restricted Stock Unit or dividend equivalent by the Participant shall be null, void and without effect. The rights and protections of the Company hereunder shall extend to any successors or assigns of the Company.  This Grant may be assigned by the Company without the Participant’s consent.  
15.Withholding. The Participant shall be required to pay to the Employer, or make other arrangements satisfactory to the Employer to provide for the payment of, any federal, state, local or other taxes that the Employer is required to withhold with respect to the grant, vesting and redemption of the Restricted Stock Units and payment of dividend equivalents. Any tax withholding obligation of the Employer with respect to the redemption of the Restricted Stock Units may, at the Committee’s discretion, be satisfied by having shares of Company Stock withheld, up to an amount that does not exceed the minimum applicable withholding tax rate for federal (including FICA), state, local and other tax liabilities.  
16.Effect on Other Benefits. The value of shares of Company Stock and dividend equivalents distributed with respect to the Restricted Stock Units shall not be considered eligible earnings for purposes of any other plans maintained by the Company or the Employer. Neither shall such value be considered part of the Participant’s compensation for purposes of determining or calculating other benefits that are based on compensation, such as life insurance. 
17.Applicable Law. The validity, construction, interpretation and effect of this Grant shall be governed by and construed in accordance with the laws of the State of Delaware, without giving effect to the conflict of laws provisions thereof. 
18.Notice. Any notice to the Company provided for in this instrument shall be addressed to the Company in care of the General Counsel at the Company’s corporate headquarters, and any notice to the Participant shall be addressed to such Participant at the current address shown on the payroll records of the Employer, or to such other address as the Participant may designate to the Employer in writing. Any notice shall be (i) delivered by hand, (ii) delivered by a national overnight courier or delivery service, (iii) enclosed in a properly sealed envelope addressed as stated above, registered and deposited, postage prepaid, in a post office regularly maintained by the United States Postal Service, or (iv) in the case of notices by the Company to the Participant, delivered by e-mail or other electronic means (with confirmation of receipt to be made by any oral, electronic or written means). 
19.Taxation; Code Section 409A. As applicable, this Grant is intended to comply with the requirements of section 409A of the Code and shall be interpreted and administered in accordance with Code section 409A.  Notwithstanding any provision to the contrary herein, if the Restricted Stock Units constitute “deferred compensation” under section 409A of the Code, 
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distributions made with respect to this Grant may only be made in a manner and upon an event permitted by Code section 409A.  To the extent that any provision of the Grant would cause a conflict with the requirements of Code section 409A, or would cause the administration of the Grant to fail to satisfy the requirements of Code section 409A, such provision shall, to the extent practicable if permitted by applicable law, be deemed null and void.  In the event that it is determined not feasible to void a provision of this Grant, such provision shall be construed in a manner as to comply with the Code section 409A requirements. This Grant may be amended without the consent of the Participant in any respect deemed by the Committee or its delegate to be necessary in order to comply with Code section 409A. Unless a valid election is made pursuant to Paragraph 5 above, in no event may the Participant, directly or indirectly, designate the calendar year of distribution.  Notwithstanding anything in the Plan or the Grant to the contrary, the Participant shall be solely responsible for the tax consequences of this Grant, and in no event shall the Company have any responsibility or liability if this Grant does not meet any applicable requirements of Code section 409A.
20.Severability.  In the event one or more of the provisions of this Grant should, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect any other provisions of this Grant, and this Grant will be construed as if such invalid, illegal or unenforceable provision had never been contained herein.
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IN WITNESS WHEREOF, the Company has caused its duly authorized officer to execute this Grant, effective as of the Date of Grant. 
AMERICAN WATER WORKS COMPANY, INC.
By:   Walter Lynch

Its:   President and CEO
8pirs9-30x20ex101

CONFIDENTIAL                                                        Exhibit 10.1             CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT                                                           (For Study PRS‐343‐PCS_09_20 and Lilly I4T-NS-I025)   

 

                                 Table of Contents                                    (continued)                                                                            Page  Article 1.    Definitions ..........................................................................................................1   Article 2.    General Principles .............................................................................................6     Section 2.1.  Contribution of Parties .................................................................................6    Section 2.2.  Standard of Performance .............................................................................6    Section 2.3.  Non-Exclusive Relationship .........................................................................6    Section 2.4.  Manufacturing Representations and Warranties ......................................6    Section 2.5.  Subcontractors ..............................................................................................7    Section 2.6.  No Additional Obligations to Supply ..........................................................7    Section 2.7.  Other Studies .................................................................................................7   Article 3.    Conduct of the Study ........................................................................................7     Section 3.1.  Sponsor of Study ...........................................................................................7    Section 3.2.  Performance ..................................................................................................8    Section 3.3.  Compliance and Regulatory Discussions; Right of Reference ..................8    Section 3.4.  Reports and Documentation ........................................................................9    Section 3.5.  Access to Clinical Data .................................................................................9    Section 3.6.  Sample Use and Ownership .......................................................................10    Section 3.7.  Ownership of Clinical Data ........................................................................10    Section 3.8.  Roles of Project Managers .........................................................................10    Section 3.9.  Supply Chain Representative .....................................................................11    Section 3.10. Study Report ................................................................................................11    Section 3.11. Future Business Opportunities ..................................................................11    Section 3.12. Partnership, Licensing, Assignment, and Transfer; Party Owned                  Materials ......................................................................................................11   Article 4.    Protocol and Related Documents ...................................................................11     Section 4.1.  Protocol ........................................................................................................11    Section 4.2.  Patient Informed Consent ..........................................................................12    Section 4.3.  Sunshine Reporting .....................................................................................12   Article 5.    Adverse Event Reporting ...............................................................................12     Section 5.1.  Pharmacovigilance ......................................................................................12    Section 5.2.  Prevailing Terms .........................................................................................13   Article 6.    Term and Termination ...................................................................................13     Section 6.1.  Term .............................................................................................................13    Section 6.2.  Lilly Termination for Unsafe Use ..............................................................13    Section 6.3.  Termination for Material Breach ..............................................................13    Section 6.4.  Termination for Patient Safety ..................................................................13    Section 6.5.  Termination for Regulatory Action...........................................................14                                         i 

 

                                 Table of Contents                                    (continued)                                                                            Page    Section 6.6.  Return of Lilly Compound .........................................................................14    Section 6.7.  Immediate Termination for Breach ..........................................................14    Section 6.8.  Survival ........................................................................................................14    Section 6.9.  No Prejudice to Claims ...............................................................................14    Section 6.10. Return of Confidential Information ..........................................................15    Section 6.11. Reimbursements ..........................................................................................15   Article 7.    Costs of the Study ............................................................................................15   Article 8.    Supply and Use of the Compounds ................................................................15     Section 8.1.  Supply of the Compounds ..........................................................................15    Section 8.2.  Provision of Compounds ............................................................................15    Section 8.3.  Labeling and Packaging; Use, Handling and Storage .............................16    Section 8.4.  Changes to Manufacturing .........................................................................16    Section 8.5.  Product Testing; Noncompliance ..............................................................16    Section 8.6.  Resolution of Discrepancies ........................................................................18    Section 8.7.  Investigations ...............................................................................................18    Section 8.8.  Shortage; Allocation ...................................................................................18    Section 8.9.  Manufacturing Records ..............................................................................18    Section 8.10. Quality ..........................................................................................................19    Section 8.11. Audits and Inspections................................................................................19    Section 8.12. VAT ..............................................................................................................19   Article 9.    Confidentiality .................................................................................................19     Section 9.1.  Treatment of Confidential Information ....................................................19    Section 9.2.  Jointly Owned Confidential Information .................................................19    Section 9.3.  Disclosure of Confidential Information ....................................................20    Section 9.4.  Confidential Information with PHI ...........................................................20   Article 10.   Intellectual Property .......................................................................................20     Section 10.1. Joint Ownership and Prosecution .............................................................20    Section 10.2. Inventions Owned by Sponsor ...................................................................21    Section 10.3. Inventions Owned by Lilly .........................................................................22    Section 10.4. Mutual Freedom to Operate for Combination Inventions ......................22   Article 11.   Reprints and Rights of Cross-Reference .......................................................22   Article 12.   Press Releases and Publications .....................................................................22     Section 12.1. Public Announcements ...............................................................................22    Section 12.2. Registration of Clinical Trial .....................................................................23    Section 12.3. Publication ...................................................................................................23    Section 12.4. Review of Materials ....................................................................................23                                         ii 

 

                                 Table of Contents                                    (continued)                                                                            Page    Section 12.5. Acknowledgments .......................................................................................24   Article 13.   General Representations and Warranties; Disclaimers ..............................24     Section 13.1. General Representations ............................................................................24    Section 13.2. No Guaranteed Results ...............................................................................24    Section 13.3. Anti-Corruption ..........................................................................................24    Section 13.4. Compliance ..................................................................................................26    Section 13.5. NO OTHER REPRESENTATIONS AND WARRANTIES ...................27   Article 14.   Insurance; Indemnification; Limitation of Liability ...................................27     Section 14.1. Insurance......................................................................................................27    Section 14.2. Indemnification ...........................................................................................27    Section 14.3. Study Subjects .............................................................................................28    Section 14.4. LIMITATION OF LIABILITY .................................................................28   Article 15.   Miscellaneous ...................................................................................................29     Section 15.1. Use of Name .................................................................................................29    Section 15.2. Force Majeure .............................................................................................29    Section 15.3. Entire Agreement; Modification................................................................29    Section 15.4. Assignment and Sub-Contracting..............................................................30    Section 15.5. Invalid Provision .........................................................................................30    Section 15.6. No Additional Obligations ..........................................................................30    Section 15.7. Dispute Resolution and Jurisdiction .........................................................30    Section 15.8. Notices ..........................................................................................................30    Section 15.9. Relationship of the Parties .........................................................................31    Section 15.10. Counterparts and Due Execution ..............................................................31    Section 15.11. Condition Precedent ...................................................................................31    Section 15.12. Construction ................................................................................................31                                             iii 

 

 Confidential           CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT                  (For Study PRS‐343‐PCS_09_20 and Lilly I4T-NS-I025)          This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT              (this   "Agreement"), made as of August 10, 2020 (the "Effective Date"), is by and between Pieris   Pharmaceuticals, Inc., having a place of business at 255  State  Street,  9th  floor, Boston,   Massachusetts 02109 ("Sponsor"), and Eli Lilly and Company, having a place of business at Lilly   Corporate Center, Indianapolis, Indiana 46285 ("Lilly").  Lilly and Sponsor are each referred to   herein individually as "Party" and collectively as "Parties".                                     RECITALS       A. Lilly is developing the Lilly Compound (as defined below) for the treatment of certain         tumor types.       B. Sponsor is developing the Sponsor Compound (as defined below) for the treatment of         certain tumor types.      C. Sponsor desires to sponsor a clinical trial in which the Sponsor Compound and the Lilly        Compound would be dosed concomitantly or sequentially.       D. Lilly and Sponsor, consistent with the terms of this Agreement, desire to collaborate as        more fully described herein, including through Lilly providing the Lilly Compound to         Sponsor for the Study (as defined below).          NOW, THEREFORE, in consideration of the premises and of the following mutual   promises, covenants and conditions, the Parties, intending to be legally bound, mutually agree as   follows:                                     ARTICLE 1.                                   DEFINITIONS.            For all purposes of this Agreement, the capitalized terms defined in this Article 1 and   throughout this Agreement shall have the meanings herein specified.          "Adverse Event (AE)" means any untoward medical occurrence in a patient or clinical   investigation subject administered with a pharmaceutical product and which does not necessarily   have to have a causal relationship with this treatment.          "Affiliate" means, with respect to either Party, a firm, corporation or other entity which   directly or indirectly owns or controls said Party, or is owned or controlled by said Party, or is   under common ownership or control with said Party.  The word "control" means (i) the direct or  indirect ownership of fifty percent (50%) or more of the outstanding voting securities of a legal  entity, or (ii) possession, directly or indirectly, of the power to direct the management or policies  of a legal entity, whether through the ownership of voting securities, contract rights, voting rights,  corporate governance or otherwise.                                       CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                        Page 1                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential         "Agreement" means this agreement, as amended by the Parties from time to time, and as  set forth in the preamble.         "Applicable Law" means those federal, state, local, national and regional laws applicable  to the activities hereunder, including performance of clinical trials, medical treatment, the  processing and protection of personal and medical data (such as those specified in the regulations  issued under GDPR, CCPA or HIPAA), and the Manufacture, processing, distribution of the  Compounds, as may be amended and in effect from time to time, including the United States  Federal Food, Drug and Cosmetic Act (21 U.S.C. 301) and applicable federal, state and local laws  and regulations, applicable cGMP and GCP and all other applicable laws and regulations, of any  other applicable jurisdiction (each a "Regulatory Authority" and collectively, "Regulatory  Authorities"), including export control and economic sanctions regulations which prohibit the  shipment of United States-origin products and technology to certain restricted countries, entities  and individuals; anti-bribery and anti-corruption laws pertaining to interactions with government  agents, officials and representatives; laws and regulations governing payments to healthcare  providers; and any United States or other country's or jurisdiction's successor or replacement  statutes, laws, rules, regulations and directives relating to the foregoing.          "Business Day" means any day other than a Saturday, Sunday or any public holiday in the  country where the applicable obligations are to be performed.         "CCPA" means the California Consumer Privacy Act of 2018, as amended from time to  time.         "cGMP"  means the current Good Manufacturing Practices officially published and  interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from  time to time and are applicable to the Manufacture of the Compounds.          "Clinical Data" means all data (including raw data) and results generated under the Study;  excluding, however, Sample Testing Results (defined below), including, without limitation, all  reports submitted by Study site(s) to Sponsor pursuant to the Study, provided however that the  term “Clinical Data” shall not include medical records of Study subjects.          "CMC" means Chemistry Manufacturing and Controls.           "Compounds" means the Lilly Compound and the Sponsor Compound.  A "Compound"  means either the Lilly Compound or the Sponsor Compound, as applicable.         "Combination" means the use or method of using the Lilly Compound and the Sponsor  Compound in concomitant or sequential administration.         "Confidential Information" means any information, Know-How or other proprietary  information or materials furnished to one Party by the other Party pursuant to this Agreement,  except to the extent that such information or materials:  (a) was already known to the receiving  Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party,  as demonstrated by competent evidence; (b) was generally available to the public or otherwise part  of the public domain at the time of its disclosure to the receiving Party; (c) became generally                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 2                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential   available to the public or otherwise part of the public domain after its disclosure and other than  through any act or omission of the receiving Party in breach of this Agreement; (d) was disclosed  to the receiving Party by a Third Party who had no obligation to the disclosing Party not to disclose  such information to others; or (e) was subsequently developed by the receiving Party without use  of the Confidential Information, as demonstrated by competent evidence.          "CTA"  means an application to a Regulatory Authority for purposes of requesting the  ability to start or continue the Study, including an IND.         "Delivery" shall have the meaning set forth in Section 8.2.1.         "Dispute" has the meaning set forth in Section 15.7.1.         "Effective Date" has the meaning set forth in the preamble.         "EMA"  means the European Medicines Agency, or a successor Regulatory Authority  thereto having similar responsibilities with respect to pharmaceutical products.         "FDA" means the United States Food and Drug Administration or any successor entity  thereto.         "GCP"  means the Good Clinical Practices officially published by EMA, FDA and the  International Conference on Harmonisation of Technical Requirements for Registration of  Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable  to the testing of the Compounds in the Study.          "GDPR" means Regulation (EU) 2016/679 of the European Parliament and of the Council  of 27 April 2016 on the protection of natural persons with regard to the processing of personal data  and on the free movement of such data, and any implementing directive or related legislation, rule,  regulation, and regulatory guidance, as amended, extended, repealed and replaced, or re-enacted  from time-to-time.         "Good Distribution Practices" or "GDP" has the meaning set forth in the Quality  Agreement.         "Government Official" means:  (i) any officer or employee of:  (a) a government, or any  department or agency thereof; (b) a government-owned or controlled company, institution, or other  entity, including a government-owned hospital or university; or (c) a public international  organization (such as the United Nations, the International Monetary Fund, the International  Committee of the Red Cross, and the World Health Organization), or any department or agency  thereof; (ii) any political party or party official or candidate for public or political party office; and  (iii) any person acting in an official capacity on behalf of any of the foregoing.         "HIPAA"  means United States Health Insurance Portability and Accountability Act of  1996, as amended from time to time.         "IND" means the Investigational New Drug Application filed or to be filed with the FDA  as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 3                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    application in the jurisdictions outside the United States, including an "Investigational Medicinal   Product Dossier" filed or to be filed with the Regulatory Authorities in the European Union.          "Internal Compliance Codes" has the meaning set forth in Section 13.4.2.          "Inventions" means all inventions and discoveries which are made or conceived in the   performance  of  the  Study  and/or  which  are  made  or  conceived  by  a  Party  through  use  of  the   Clinical Data.          "Jointly Owned Invention" has the meaning set forth in Section 10.1.1.          "Joint Patent" means a patent that issues from a Joint Patent Application.          "Joint Patent Application" has the meaning set forth in Section 10.1.2.          "Know-How" means any proprietary invention, innovation, improvement, development,   discovery, computer program, device, trade secret, method, know-how, process, technique or the   like, including manufacturing, use, process, structural, operational and other data and information,   whether or not written or otherwise fixed in any form or medium, regardless of the media on which   contained and whether or not patentable or copyrightable, that is not generally known or otherwise   in the public domain.          "Liability" has the meaning set forth in Section 14.2.1.          "Lilly" has the meaning set forth in the preamble.          "Lilly Class Compound" means  any  one  or  more  VEGFR2  antagonist  molecule,   including an antibody such as an anti-VEGFR2 antibody or a small molecule inhibitor that is a  specific and selective antagonist of VEGFR2.          "Lilly Compound"  means  ramucirumab, excluding, however, any biosimilar of   ramucirumab other than a biosimilar owned or controlled by Lilly or its Affiliates.          "Manufacture," "Manufactured," or "Manufacturing" means all stages of the   manufacture of a Compound, including planning, purchasing, manufacture, processing,   compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality   assurance, sample retention, stability testing, release, dispatch and supply, as applicable.           "Manufacturing Site" means the facilities where a Compound is Manufactured by or on   behalf of a Party, as such Manufacturing Site may change from time to time in accordance with   Section 8.4 (Changes to Manufacturing).           "Non-Conformance" means, with respect to a given unit of Compound, (i) an event that   deviates from an approved cGMP requirement with respect to the applicable Compound, such as   a procedure, Specification, or operating parameter, or that requires an investigation to assess   impact to the quality of the applicable Compound or (ii) that such Compound failed to meet the   applicable representations and warranties set forth in Section  2.4. Classification of a Non-  Conformance is detailed in the Quality Agreement.                                       CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                        Page 4                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential         "Party" has the meaning set forth in the preamble.         "Party Specific Regulations" has the meaning set forth in Section 13.4.2.         "Pharmacovigilance Agreement" has the meaning set forth in Section 5.1.         "Project Manager(s)" has the meaning set forth in Section 3.8.         "Protocol" means the written documentation that describes the Study and sets forth  specific activities to be performed as part of the Study conduct, a summary of which is attached  hereto as Appendix A.         "Quality Agreement" means that certain Quality Agreement entered into between  Sponsor and Lilly which governs the essential quality obligations of each party in the manufacture,  testing and release of the Compounds, as the same may be amended from time to time.         "Regulatory Approvals" means any and all permissions (other than approvals that are  required to Manufacture a Party's Compound in accordance with Applicable Law) required to be  obtained from Regulatory Authorities and any other competent authority for the development,  registration, importation and distribution of a Compound in the United States, Europe or other  applicable jurisdictions for use in humans.          "Regulatory Authorities" has the meaning set forth in the definition of Applicable Law.         "Related Agreements" means the Pharmacovigilance Agreement and the Quality  Agreement.         "Samples" means urine, blood or tissue samples from patients participating in the Study.         "Sample Testing" means the analyses to be performed by either Party using the applicable  Samples, as described in the Sample Testing Schedule.         "Sample Testing Results" means those results arising from the Sample Testing which are  to be shared between Lilly and Sponsor, as set forth in the Sample Testing Schedule.         "Sample Testing Schedule" means the schedule attached hereto as Appendix B.         "Specifications" means, with respect to a given Compound, the set of requirements for  such Compound as set forth in the Quality Agreement.         "Sponsor" has the meaning set forth in the preamble.         "Sponsor Class Compound" means any one or more  bi- or multi- specific molecule  that  agonizes CD137 (4-1BB).         "Sponsor Compound" means cinrebafusp alfa (PRS-343), a bivalent, bispecific fusion  protein targeting CD137 (4-1BB) and HER2 excluding, however, any biosimilar of PRS-343 other  than a biosimilar owned or controlled by Sponsor or its Affiliates.                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 5                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential         "Study" means the Phase 2 study of the Sponsor Compound and the Lilly Compound,  together with chemotherapy, a summary of which is attached hereto as Appendix A.          "Study Completion" has the meaning set forth in Section 3.5.         "Territory" means anywhere in the world.         "Third Party" means any person or entity other than Sponsor, Lilly or their respective  Affiliates.                                    ARTICLE 2.                             GENERAL PRINCIPLES.           Section 2.1. Contribution of Parties.  Each Party shall contribute to the Study such  resources as are reasonably necessary to fulfill its obligations set forth in this Agreement.         Section 2.2. Standard of Performance.  Each Party agrees to (i) act in good faith in  performing its obligations under this Agreement and each Related Agreement, (ii) commit to  perform its obligations under this Agreement and each Related Agreement carefully and  accurately, to the best of its respective ability, with qualified staff and on the basis of sound  scientific and engineering principles and in compliance with Applicable Laws, and (iii) shall notify  the other Party as promptly as possible in the event of any Manufacturing delay that is likely to  adversely affect supply of its Compound as contemplated by this Agreement. As part of this  standard of performance, the Parties agree that the current coronavirus pandemic may result in  unexpected delays that would not be considered a breach of this Section 2.2 by such Party.         Section 2.3. Non-Exclusive Relationship.  Each Party acknowledges and agrees that  this arrangement is not an exclusive arrangement on its part and that each Party may enter similar  arrangements with other parties including parties that may compete with the other Party.         Section 2.4. Manufacturing Representations and Warranties.                      2.4.1  Lilly agrees to Manufacture and supply the Lilly Compound for             purposes of the Study as set forth in Article 8, and Lilly hereby represents and             warrants to Sponsor that, at the time of Delivery of the Lilly Compound, such Lilly             Compound shall have been Manufactured and supplied in compliance with the             Specifications for the Lilly Compound and in compliance with Applicable Law,             including cGMP and health, safety and environmental protections, as more             particularly set forth in the Quality Agreement.  Sponsor agrees to Manufacture and             supply the Sponsor Compound for purposes of the Study as set forth in Article 8,             and Sponsor hereby represents and warrants to Lilly that, at the time of use of the             Sponsor Compound, such Sponsor Compound shall have been Manufactured and             supplied in compliance with the Specifications for the Sponsor Compound and in             compliance with Applicable Law, including cGMP and health, safety and             environmental protections, as more particularly set forth in the Quality Agreement.                                       CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 6                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential                     2.4.2  Lilly hereby represents and warrants to Sponsor that, at the time of              Delivery of the Lilly Compound, such Lilly Compound shall be free from any Non-             Conformance.                     2.4.3  Sponsor hereby represents and warrants to Lilly that, at the time of              use of the Sponsor Compound, such Sponsor Compound shall be free from any Non-             Conformance.                     2.4.4  Without limiting the foregoing, each Party is responsible for              obtaining Regulatory Approvals (including facility licenses) that are required to              Manufacture its Compound in accordance with Applicable Law (provided that for              clarity, Sponsor shall be responsible for obtaining Regulatory Approvals for the              Study as set forth in Section 3.3).          Section 2.5. Subcontractors.  Each Party shall have the right to subcontract any portion   of its obligations hereunder:  (i) to its own Affiliates, without the other Party's written consent; or  (ii) to third parties, provided that the other Party's Project Manager has approved (in a written  document, but such approval not to be unreasonably withheld, conditioned or delayed) the use of  such third parties in the performance of such activities, and provided further that no consent shall  be necessary for either Party's delegation to or use of contract research organizations or other third  parties that (A) are already conducting clinical trials of such Party's Compound and are set forth  in the Protocol as performing such Study activities, or (B) are already conducting Sample Testing  for such Party.  In any event, each Party shall remain fully liable for the performance of its  subcontractors.  Notwithstanding the foregoing, the Parties agree to Sponsor’s use of the  subcontractors identified in Appendix B. Each Party shall ensure that each of its subcontractors  performs its obligations pursuant to the terms of this Agreement, including the Appendices  attached hereto.  Each Party shall use reasonable efforts to obtain and maintain copies of  documents relating to the obligations performed by such subcontractors that are held by or under  the control of such subcontractors and that are required to be provided to the other Party under this  Agreement.          Section 2.6. No Additional Obligations to Supply.  This Agreement does not create   any obligation on the part of Lilly to provide the Lilly Compound for any activities other than in   connection with the Study, nor does it create any obligation on the part of Sponsor to provide the   Sponsor Compound for any activities other than the Study.            Section 2.7. Other Studies.  Nothing in this Agreement shall (i) prohibit either Party   from performing clinical studies other than the Study relating to its own Compound, either   individually or in combination with any other compound(s) or product(s), in any therapeutic area,   or (ii) create an exclusive relationship between the Parties with respect to any Compound.                                     ARTICLE 3.                             CONDUCT OF THE STUDY.            Section 3.1. Sponsor of Study.  Sponsor shall act as the sponsor of the Study and shall   hold each IND/CTA  and/or  equivalent  in each jurisdictions relating to the Study; provided,   however,  that  in  no  event  shall  Sponsor  file  a  separate  IND/CTA  and/or  equivalent  in  other                                      CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                        Page 7                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential   jurisdictions in relation to the Study unless required by Regulatory Authorities to do so.  If a  Regulatory Authority requests a separate IND/CTA and/or equivalent in other jurisdictions for the  Study, the Parties will meet and mutually agree on an approach to address such requirement.          Section 3.2. Performance.  Sponsor shall ensure that the Study is performed in  accordance with this Agreement, the Protocol and Applicable Law, including GCP.          Section 3.3. Compliance and Regulatory Discussions; Right of Reference.                      3.3.1  Sponsor shall ensure that all directions from any Regulatory             Authority and/or ethics committee with jurisdiction over the Study are followed.              Further, Sponsor shall ensure that all required Regulatory Approvals from any             Regulatory Authority and/or ethics committee with jurisdiction over the Study are             obtained prior to initiating performance of the Study.  Sponsor shall participate in             and lead all discussions with any Regulatory Authority regarding the Study,             provided, however, that Lilly shall have the right (but no obligation) to participate             in any discussions with a Regulatory Authority to the extent such discussions include             substantive or material regarding matters related to the Lilly Compound. For such             discussions, Sponsor shall consider in good faith any advance comments from Lilly             regarding the planned content of such discussions. For the sake of clarity, any             discussions related to safety or efficacy of the Lilly Compound shall be considered             substantive and material.                      3.3.2 Sponsor will promptly provide Lilly with a copy of any written             reports (or excerpts thereof) from Regulatory Authorities to the extent related to the             Lilly Compound within a reasonable time after receipt thereof and shall provide             Lilly with draft copies of any responses to a Regulatory Authority (or excerpts             thereof)  to the extent related to the Lilly Compound within a reasonable time prior             to submission to such Regulatory Authority.  Sponsor shall reasonably consider             Lilly's comments to such draft response, with any disputes being escalated through             the Project Managers (as defined in Section 3.8).                     3.3.3  Each Party grants to the other Party a non-exclusive, non-            transferable (except in connection with a permitted assignment, sublicense or             subcontract, including those contemplated under Section 3.12) "right of reference"             (as defined in US FDA 21 CFR 314.3(b)), or similar "right of reference" as defined             in applicable regulations in the relevant part of the Territory, with respect to Clinical             Data and results related to Compounds, solely as necessary for the other Party to             prepare, submit and maintain regulatory submissions related to the other Party's             Compound and Regulatory Approvals.                    3.3.4  Notwithstanding anything to the contrary in this Agreement, neither             Party shall have any right to access the other Party's CMC data with respect to its             Compound.  If necessary to support conduct of the Study, Lilly will authorize FDA             and other applicable Regulatory Authorities to cross-reference the appropriate Lilly             Compound U.S. and EU Regulatory Approvals  (if the Lilly Compound is             commercial material) or the appropriate INDs or CTAs (if the Lilly Compound is                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 8                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential               clinical trial material) to provide data access to Sponsor and/or  the  appropriate              Regulatory Authority.  If the cross-references to such Regulatory Approvals and the              equivalency statements are not deemed sufficient by a Regulatory Authority in a              country approved by Lilly as part of the Study, Lilly, shall discuss in good faith the              filing of the complete CMC components of the Common Technical Document for              each Lilly Compound (the "CMC Data") with such Regulatory Authority, with a              letter of authorization for Sponsor to cross-reference the CMC Data for the review              of the CTA; however, Sponsor shall have no right to directly access the CMC Data.               Sponsor shall reimburse Lilly for reasonable and direct costs for preparing the CMC              Data for filing with such Regulatory Authority(ies) and related filing costs.  In              addition to the foregoing, Lilly shall provide any additional materials mutually              agreed to by the Parties to Sponsor on a schedule agreed to by the Parties, and shall              provide such other documents and information as may be requested by a Regulatory              Authority to such Regulatory Authority following such request by the Regulatory              Authority, to the extent such documents and information are reasonably available to              Lilly.  Lilly hereby agrees that it shall review Section D of the European Clinical              Trials Database (EudraCT) Application Form Worksheets completed by Sponsor              with respect to the Lilly Compound for purposes of the CTA and, no later than [***]              business days, provide any corrections or additions required for accuracy and              completeness of such worksheets.                      3.3.5  For avoidance of doubt, Sponsor shall not be responsible for              complying with any laws or regulations that solely relate to the commercialization              of the Lilly Compound.          Section 3.4. Reports and Documentation.  Sponsor shall maintain reports and all   related documentation (paper or electronic) in good scientific manner, consistent with industry   norms and in compliance with Applicable Law.  Each Party shall provide to the other any Study   information and documentation (excluding information and documentation relating to the Sample   Testing other than the Sample Testing Results themselves) reasonably requested by such other   Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by   any Regulatory Authority, in each case, to the extent related to the Study or such Party's   Compound, (ii) conduct the Sample Testing, (iii) satisfy any contractual obligation to a   subcontractor engaged pursuant to Section  2.4 hereof, and (iv) in the case of Lilly, determine   whether the Study has been performed by Sponsor in accordance with this Agreement.           Section 3.5. Access to Clinical Data.  Subject to Applicable Law, Sponsor shall obtain   the consent of Study participants to share Clinical Data with Lilly, including for secondary  purposes that are reasonably identified to Pieris in a manner that allows for their inclusion in the  consent, in accordance with the terms of this Agreement.  To the extent permitted under Applicable  Law, Sponsor shall provide to Lilly copies of Clinical Data, in a summary, electronic form or other  mutually agreeable alternate form, (a) at major decision points during the Study to track study  progress, (b) at an appropriate time to support publications, (c) as needed to support interpretation  of Clinical Data including efficacy analyses as mutually agreed by the Project Managers, or (d) as  otherwise agreed upon by the Project Managers.  Subject to Applicable Law, Sponsor shall provide  to Lilly a complete copy of the Clinical Data in the manner and format prepared by the Sponsor  no later than [***] days following Study Completion. "Study Completion" shall be deemed to                                     CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                        Page 9                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    occur following final lock of the Study database and when analysis for meeting Study endpoints   has been completed or as otherwise agreed by the Project Managers.   Subject to Applicable Law   and to the extent applicable, Sponsor shall ensure that all patient authorizations and consents   required under HIPAA, GDPR or any other similar Applicable Law in connection with the Study  permit such sharing of Clinical Data with Lilly.           Section 3.6. Sample Use and Ownership.  Notwithstanding anything to the contrary in   this Section 3.6, Sponsor shall retain all Samples and conduct all Sample Testing.   Each Party   shall use the Samples only for the Sample Testing and in compliance with the applicable informed   consent forms and each Party shall be responsible for conducting the Sample Testing related to its   own Compound.  [***]  Sponsor shall obtain the consent of Study participants to share Sample   Testing Results with Lilly in accordance with the terms of this Agreement, to the extent applicable.    Sponsor shall provide to Lilly the Sample Testing Results for the Sample Testing conducted by or   on behalf of Sponsor, in electronic form or other mutually agreeable alternate form, as may be   permissible under Applicable Law, and on the timelines specified in the Sample Testing Schedule   or other mutually agreed timelines.  Each Party hereby grants each of the other Parties hereto a   [***] to use the Sample Testing Results for the sole purposes of [***].  Sponsor shall be  responsible for the conduct of all Sample Testing and Lilly shall provide reasonable access and  support to Sponsor in the conduct of the Lilly Compound-specific Sample Testing as indicated on  Appendix B.  Responsibilities shall include, but are not limited to, data generation and payment to   conduct the assay.  The Parties agree to provide sufficient quantities of their Compounds for   interference testing in bioanalytical or proprietary assays in order to confirm, as applicable, that   their Compound does not interfere with the other Party's assay performance.  Initial experiments   may be performed to determine impact to assay performance and will follow a validated protocol   and/or standard operating procedure.  [***]          Section 3.7. Ownership of Clinical Data.  All Clinical Data generated under this   Agreement, [***].  It is understood and acknowledged by the Parties that positive Clinical Data   could be used to obtain label changes for the Compounds.  Lilly covenants not to disclose any   unpublished Clinical Data [***], and Sponsor covenants not to disclose any unpublished Clinical   Data [***].          Section 3.8. Roles of Project Managers.  Each Party shall designate a Project Manager   who shall be responsible for implementing and coordinating activities and facilitating the exchange   of scientific information between the Parties with respect to the Study.  The Project Managers shall  meet as soon as practicable after the Effective Date and then no less than twice yearly, and more  often as reasonably considered necessary at the request of either Party, to provide an update on  Study progress.  Prior to any such meeting, the Sponsor Project Manager shall provide an update  in writing to the Lilly Project Manager, which update shall contain information about overall Study  progress, recruitment status, and other information relevant to the conduct of the Study.  Sponsor  Project Manager shall supplement the update as necessary to reflect any material information  discussed at such meetings.  Sponsor Project Manager shall schedule reviews of Clinical Data in  alignment with Appendix C (Data Sharing Table).  In the event that an issue arises and the Project   Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall   be elevated to the Senior Vice President, Head of Clinical Development, for Sponsor, and the Vice  President of Oncology Late Phase Development for Lilly.                                        CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 10                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential          Section 3.9. Supply Chain Representative.  Each Party shall appoint a supply chain   representative to hold telephone discussions at a mutually agreed-upon frequency to review the   quantities of Sponsor Compound and Lilly Compound needed for the Study (in accordance with   Article 8 and Appendix D) and any other supply chain issues that may arise during the Study.          Section 3.10. Study Report.  Sponsor shall provide Lilly with (i) an electronic draft of   each study report for Lilly to provide comments to Sponsor within [***] days of receipt of such   draft final study report and (ii) the final version of the study report promptly following Study   Completion.  Sponsor shall consider in good faith any comments provided by Lilly on the draft of  the final study report and shall not include any statements relating to the Lilly Compound which  have not been approved by Lilly.          Section 3.11. Future Business Opportunities.  Notwithstanding anything in this   Agreement to the contrary, each Party acknowledges and agrees that the other Party may have   present or future business activities or opportunities, including business activities or opportunities   with Third Parties, involving Sponsor Class Compounds, in the case of Lilly, or Lilly Class   Compounds, in the case of Sponsor, or other similar products, programs, technologies or processes.    Accordingly, each Party acknowledges and agrees that nothing in this Agreement shall be   construed as a representation or inference that the other Party will not develop for itself, or enter   into business relationships with other Third Parties regarding, any products, programs, studies   (including combination studies), technologies or processes that are similar to or that may compete   with the Combination or any other product, program, technology or process, including Sponsor   Class Compound or Lilly Class Compound, provided that the Clinical Data, Sample Testing   Results, Jointly Owned Inventions, and Confidential Information are used or disclosed in   connection therewith consistent with and not in violation of Section 3.3, Section 3.5, Section 3.6,   Section 3.7, Section 9.1 or Article 10 of this Agreement.          Section 3.12. Partnership, Licensing, Assignment, and Transfer; Party Owned   Materials.  Nothing in this Agreement shall prohibit or restrict a Party from licensing, partnering,   assigning, co-developing, or otherwise transferring in whole or in part to an Affiliate or Third Party   its interest in its Compound and the related Clinical Data, Confidential Information, Sample  Testing Results or Jointly Owned Inventions (along with this Agreement in the case of a transfer   or assignment), including freedom to use such information; provided, however, that in the case of   any such license, partnership, assignment, co-development or transfer in whole or in part, the   licensee, partner, assignee or transferee shall agree in writing to be bound by the terms of this   Agreement.                                      ARTICLE 4.                     PROTOCOL AND RELATED DOCUMENTS.            Section 4.1. Protocol.  A summary of the initial Protocol, entitled "A Phase 2, Multi‐  Center, Open‐Label Study of Cinrebafusp alpha (PRS‐343) in Combination with Ramucirumab  and Paclitaxel in Patients with HER2‐Positive Gastric or GEJ Adenocarcinoma", has been agreed   to by the Parties as of the Effective Date, and is attached as Appendix A.  Sponsor shall have the   final decision regarding the contents of the Protocol; provided, however, that any material changes   to the Protocol (other than relating solely to the Sponsor Compound), and any changes (whether   or not material) relating to the Lilly Compound, shall require Lilly's prior written consent, which                                      CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 11                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    shall not be unreasonably withheld, conditioned or delayed.  Any such proposed changes will be   sent in writing to Lilly's Project Manager.  Lilly will provide such consent, or a written explanation  for why such consent is being withheld, within [***] Business Days of receiving a copy of  Sponsor's requested changes; provided that if Lilly fails to provide such written explanation within  such [***] Business Day period, then Lilly shall be deemed to have consented to such change or  changes.            Section 4.2. Patient Informed Consent.  Sponsor shall prepare the patient informed   consent form for the Study (which shall include any required consent for the Sample Testing) in   consultation with Lilly regarding any safety language related to the Lilly Compound (it being   understood and agreed that the portion of the informed consent form relating to the safety of the   Lilly Compound will be provided to Sponsor by Lilly).  Any changes to such form that relate to   the Sample Testing or the Lilly Compound shall be subject to Lilly's review and prior written   consent.  Any such proposed changes will be sent in writing to Lilly's Project Manager.  Lilly will   provide such consent, or a written explanation for why such consent is being withheld, within   [***] Business Days of receiving a copy of Sponsor's requested changes; provided that if Lilly   fails to provide such written explanation within such [***] Business Day period, then Lilly shall   be deemed to have consented to such change or changes.           Section 4.3. Sunshine Reporting.  Sponsor will be responsible for reporting payments   and other transfers of value made to health care professionals (e.g. investigators, steering   committee members, data monitoring committee members, consultants, etc.) in connection with   its role as Sponsor of the Study in accordance with reporting requirements, if any, under Applicable   Law (including the Physician Payment Sunshine Act and state gift laws, and the European   Federation of Pharmaceutical Industries and Associations Disclosure Code) and Sponsor policies.    Lilly shall provide all information required for such reporting regarding the value of the Lilly   Compound provided for use in the Study.  Such information shall be provided to the point of   contact within Sponsor's clinical supplies group who is identified to Lilly in writing upon the   execution of the Agreement and thereafter promptly following any change to such point of contact.    Lilly shall provide the necessary information regarding the value of the Lilly Compound within   [***] business days following the execution of this Agreement.  In the event that, at any time   during the term of this Agreement, the value of the Lilly Compound provided under this Agreement  changes, Lilly shall notify Sponsor of such revised value, and the effective date of such revised  value, within [***] business days following such change in value.                                     ARTICLE 5.                          ADVERSE EVENT REPORTING.            Section 5.1. Pharmacovigilance.  Sponsor will be solely responsible for compliance   with Applicable Law pertaining to safety reporting for the Study and related activities.  The Parties   (or their respective Affiliates) will execute a pharmacovigilance agreement (the   "Pharmacovigilance Agreement") prior to the initiation of clinical activities under the Study, but   in any event, within [***] days following the Effective Date of this Agreement to ensure the   exchange of relevant safety data within appropriate timeframes and in appropriate format to enable   the Parties to fulfill local and international regulatory reporting obligations and to facilitate   appropriate safety reviews.  The Pharmacovigilance Agreement will include safety data exchange   procedures governing the coordination of collection, investigation, reporting, and exchange of                                     CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 12                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    information concerning any adverse experiences, pregnancy reports, and any other safety   information arising from or related to the use of the Lilly Compound and Sponsor Compound in   the Study, consistent with Applicable Law.  Such guidelines and procedures shall be in accordance   with, and enable the Parties and their Affiliates to fulfill, local and international regulatory   reporting obligations to Regulatory Authorities.           Section 5.2. Prevailing Terms.  In the event of any inconsistency between the terms of   this Agreement and the Pharmacovigilance Agreement, the terms of this Agreement shall prevail   and govern except to the extent such inconsistent term relates directly to the pharmacovigilance   responsibilities of the Parties (including the exchange of safety data), in which case the terms of   the Pharmacovigilance Agreement shall prevail and govern.                                     ARTICLE 6.                            TERM AND TERMINATION.            Section 6.1. Term.  The term of this Agreement shall commence on the Effective Date   and shall continue in full force and effect until completion of all of the obligations of the Parties   hereunder (excluding obligations that survive termination) or until terminated by either Party   pursuant to this Article 6.          Section 6.2. Lilly Termination for Unsafe Use.  In the event that Lilly reasonably and   in good faith believes that the Lilly Compound is being used in the Study in an unsafe manner and   notifies Sponsor in writing of the grounds for such belief, the Sponsor shall have the reasonable   opportunity  to  review  and  consider  the  Sponsor’s  notification  and  grounds  and  shall promptly   respond to Lilly in writing with the actions Sponsor proposes to take or, if Sponsor disagrees with  Lilly’s  belief,  providing such a response promptly to Lilly, including the basis for such   disagreement. In the event that Lilly continues—reasonably and in good faith—to believe that that  the Lilly Compound is being used in the Study in an unsafe manner and Sponsor thereafter fails to  promptly incorporate (subject to approval by applicable Regulatory Authorities or Institutional  Review Boards) changes into the Protocol reasonably requested by Lilly to address such issue or  to otherwise in good faith address such issue, Lilly may terminate this Agreement and the supply  of the Lilly Compound effective upon written notice to Sponsor.           Section 6.3. Termination for Material Breach.  Either Party may terminate this   Agreement if the other Party commits a material breach of this Agreement, and such material   breach continues for [***] days after receipt of written notice thereof from the non-breaching   Party; provided that if such material breach cannot reasonably be cured within [***] days, the  breaching Party shall be given a reasonable period of time to cure such breach.          Section 6.4. Termination for Patient Safety.  If either Party determines in good faith,   based on a review of the Clinical Data or other Study-related Know-How or other information,   that the Study may unreasonably affect patient safety, such Party shall promptly notify the other   Party of such determination.  The Party receiving such notice may propose modifications to the   Study to address the safety issue identified by the other Party and, if the notifying Party agrees,   shall act to immediately implement such modifications; provided, however, that if the notifying   Party, in its sole discretion, believes that there is imminent danger to patients, such Party need not   wait for the other Party to propose modifications and may instead terminate this Agreement                                      CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 13                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    immediately upon written notice to such other Party.  Furthermore, if the notifying Party, in its   sole discretion, believes that any modifications proposed by the other Party will not resolve the   patient safety issue, such Party may terminate this Agreement effective upon written notice to such   other Party. Notwithstanding the foregoing, to the extent that a Party in good faith disputes a notice   of termination provided under this Section, then the SVP, Head of Clinical Development of   Sponsor and the Vice President of Oncology Late Phase Development for Lilly shall within [***]   Business Days have a discussion in good faith prior to termination.          Section 6.5. Termination for Regulatory Action.  Either Party may terminate this   Agreement [***] days following written notice to the other Party in the event that any Regulatory  Authority takes any action, or raises any objection, that precludes the terminating Party from  supplying its Compound for purposes of the Study.  Additionally, either Party shall have the right  to terminate this Agreement [***] days following written notice to the other Party in the event that  it determines in its sole discretion to discontinue development of its Compound, for medical,  scientific, legal or other reasons.           Section 6.6. Return of Lilly Compound.  In the event that this Agreement is terminated,   Sponsor shall, at Lilly's sole discretion, promptly either return or destroy all unused Lilly   Compound  in its possession and control or  in  the  possession  and  control  of  Sponsor’s   subcontractors or Affiliates, pursuant to Lilly's instructions.  If Lilly requests that Sponsor destroy   the unused Lilly Compound, Sponsor shall provide written certification of such destruction.           Section 6.7. Immediate Termination for Breach.  Either Party shall be entitled to   terminate this Agreement immediately upon written notice to the other Party, if such other Party   fails to perform any of its material obligations under Section  13.3 or materially breaches any   representation or warranty contained in Section 13.1.  Such termination shall not be exercisable by   a Party without giving notice and [***] days to cure with respect to subcontractors that have been  evaluated and cleared by such Party. Subject to Section 6.11, the non-terminating Party shall have   no claim against the terminating Party for compensation for any loss of whatever nature by virtue   of the termination of this Agreement in accordance with this Section 6.7.           Section 6.8. Survival.  The provisions of this Section 6.8, Section 3.6 (other than the   first sentence thereof), Section  3.7, Section  3.10, Section 6.6, Section 6.7 (other than the first   sentence thereof), Section 6.9, Section 6.10, Section 6.11, Section 12.2, Section 12.3, Section 12.4,   Section 12.5, Section 14.2 (Indemnification), Section 14.4 (Limitation of Liability), and Article 1   (Definitions), Article  5 (Adverse Event Reporting), Article 7 (Costs of the Study), Article  9   (Confidentiality), Article 10 (Intellectual Property), Article 11 (Reprints and Rights of Cross-  Reference), Article  12 (Press Releases and Publications), Section  15.6 (No Additional   Obligations), Section 15.7 (Dispute Resolution and Jurisdiction), Section 15.8 (Notices), Section   15.9 (Relationship of the Parties) and Section 15.12 (Construction) shall survive the expiration or   termination of this Agreement.           Section 6.9. No Prejudice to Claims.  Termination of this Agreement shall be without   prejudice to any claim or right of action of either Party against the other Party for any prior breach   of this Agreement.                                       CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 14                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential         Section 6.10. Return of Confidential Information.  Upon termination of this  Agreement, each Party and its Affiliates shall promptly return to the other Party or destroy any  Confidential Information of the other Party (other than Clinical Data, Sample Testing Results and  Inventions) furnished to the receiving Party by the other Party, except that the receiving Party shall  have the right to retain one copy for record-keeping purposes.         Section 6.11. Reimbursements.  Provided the Parties do not otherwise dispute the  circumstances of termination, in the event of termination due to Section 6.2 (only to the extent  Lilly Compound supplied under this Agreement continues to be used by Sponsor following Lilly’s  notice of its unsafe use), Section 6.3 (only in the case of termination by Lilly for Sponsor’s material  breach) or Section 6.7 above, Lilly shall be entitled to reimbursement by Sponsor for the Direct  Manufacturing Costs and Indirect Manufacturing Costs (as defined herein) incurred by Lilly for  the Lilly Compound Delivered for the Study.                                     ARTICLE 7.                             COSTS OF THE STUDY.           The Parties agree that (i) Lilly shall provide the Lilly Compound for use in the Study, as  described in Article 8 below, [***]; and (ii) Sponsor shall bear all other costs associated with the  conduct of the Study, including that Sponsor shall provide the Sponsor Compound for use in the  Study, [***].                ARTICLE 8.SUPPLY AND USE OF THE COMPOUNDS.           Section 8.1. Supply of the Compounds.  Lilly will supply, or cause to be supplied, the  quantities of its respective Compound as set forth on Appendix D on the approximate timelines set  forth in Appendix D, in each case, for use in the Study.  In the event that Sponsor determines that  the quantities of Compounds set forth on Appendix D are not sufficient to complete the Study  (due, for example, to the addition of Study sites or countries), Sponsor shall so notify Lilly, and  the Parties shall discuss in good faith regarding additional quantities of Compounds to be provided  and the schedule on which such additional quantities may be provided.  Each Party shall also  provide to the other Party a contact person for the supply of its Compound under this Agreement  as set forth in Section 3.8.  Notwithstanding the foregoing, or anything to the contrary herein, in  the event that either Party is not supplying its Compound in accordance with the terms of this  Agreement, or is allocating under Section 8.9, then the other Party shall have no obligation to  supply its Compound, or may allocate proportionally. Notwithstanding anything to the contrary  herein, Lilly shall only be obligated to supply the Lilly Compound for use in the countries set forth  in Appendix D and may decline to provide the Lilly Compound, for any reason or no reason, to  any countries not otherwise agreed to in advance between the parties or set forth in Appendix D.         Section 8.2. Provision of Compounds.                     8.2.1  Lilly  will  deliver  the  Lilly  Compound  DAP  (Incoterms  2020) to             Sponsor's, or its designee's, location as mutually agreed ("Delivery" with respect to             such Lilly Compound).  Title and risk of loss for the Lilly Compound shall transfer             from Lilly to Sponsor at Delivery.  All costs associated with the subsequent             transportation, warehousing and distribution of Lilly Compound shall be borne by                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 15                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential              Sponsor.  Sponsor will, or will cause its designee to:  (i) take delivery of the Lilly             Compound supplied hereunder; (ii) perform the acceptance procedures allocated to             it under the Quality Agreement; and (iii) subsequently label and pack, as appropriate             (in accordance with Section 8.4) and promptly ship the Lilly Compound to the Study             sites, in compliance with cGMP, GCP and other Applicable Law and the Quality             Agreement.                     8.2.2  Sponsor is solely responsible, at its own cost, for supplying             (including all Manufacturing, acceptance and release testing) the Sponsor             Compound for the Study, and the subsequent handling, storage, transportation,             warehousing and distribution of the Sponsor Compound supplied hereunder.              Sponsor shall ensure that all such activities are conducted in compliance with cGMP,             GCP GDP and other Applicable Law and the Quality Agreement.          Section 8.3. Labeling and Packaging; Use, Handling and Storage.                     8.3.1  The Parties' obligations with respect to the labeling and packaging             of the Compounds are as set forth in the Quality Agreement.  Notwithstanding the             foregoing or anything to the contrary contained herein, Lilly shall provide Lilly             Compound to Sponsor in the form set forth on Appendix D, and, unless otherwise             agreed to by the parties in writing, Sponsor shall be responsible for any applicable             labeling, packaging and leafleting such Lilly Compound in accordance with the             terms and conditions of the Quality Agreement and otherwise in accordance with             Applicable Law, including cGMP, GCP, GDP, and health, safety and environmental             protections.                     8.3.2  Sponsor shall (i) use the Lilly Compound solely for purposes of             performing the Study; (ii) not use the Lilly Compound in any manner inconsistent             with this Agreement or for any commercial purpose; and (iii) use, store, transport,             handle and dispose of the Lilly Compound in compliance with the Specifications,             Applicable Law and the Quality Agreement.  Sponsor shall not reverse engineer,             reverse compile, disassemble or otherwise attempt to derive the composition or             underlying information, structure or ideas of the Lilly Compound, and in particular             shall not analyze the Lilly Compound by physical, chemical or biochemical means             except as necessary to perform its obligations under the Quality Agreement.          Section 8.4. Changes to Manufacturing.  Each Party may make changes from time to  time to its Compound or the Manufacturing Site; provided that such changes shall be in accordance  with the Quality Agreement and proper notice is provided to the other party of such changes as set  forth in the Quality Agreement.         Section 8.5. Product Testing; Noncompliance.                      8.5.1  After Manufacturer's Release.  After manufacturer's release of the             Lilly Compound and concurrently with Delivery of the Compound to Sponsor, Lilly             shall provide Sponsor with such certificates and documentation as are described in             the Quality Agreement.  Sponsor shall, within the time defined in the Quality                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 16                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential              Agreement, perform (i) with respect to the Lilly Compound, the acceptance             procedures allocated to it under the Quality Agreement, and (ii) with respect to the             Sponsor Compound, the testing and release procedures allocated to it under the             Quality Agreement.  Sponsor shall take all steps necessary to determine that the             Sponsor Compound is suitable for release before making such Sponsor Compound             available for human use, and Lilly shall provide reasonable cooperation or assistance             as reasonably requested by Sponsor in connection with such determination with             respect to the Lilly Compound.  After Delivery by Lilly of the Lilly Compound,             Sponsor shall be responsible for storage and maintenance of the Lilly Compound,             which storage and maintenance shall be in compliance with the Specifications for             the Lilly Compound, the Quality Agreement and Applicable Law, and shall be             responsible for any failure of the Lilly Compound to meet the Specifications to the             extent caused by shipping, storage or handling conditions after Delivery to Sponsor             hereunder.                    8.5.2  Non-Conformance.                       (a)   In the event that either Party becomes aware that any Compound              may have a Non-Conformance, despite testing and quality assurance activities              (including any activities conducted by the Parties under Section 8.5.1), such Party              shall immediately notify the other Party in accordance with the procedures of the              Quality Agreement.  The Parties shall investigate any Non-Conformance in              accordance with Section 8.7 (Investigations) and any discrepancy between them              shall be resolved in accordance with Section 8.6 (Resolution of Discrepancies).                      (b)   In the event that any proposed or actual shipment of the Lilly              Compound (or portion thereof) shall be agreed to have a Non-Conformance at the              time of Delivery to Sponsor, then unless otherwise agreed to by the Parties, Lilly              shall replace such Lilly Compound as is found to have a Non-Conformance (with              respect to the Lilly Compound that has not yet been administered in the course of              performing the Study).  Unless otherwise agreed to by the Parties in writing, the             sole and exclusive remedies of Sponsor with respect to any Lilly Compound that is             found to have a Non-Conformance at the time of Delivery shall be (i) replacement             of such Lilly Compound as set forth in this Section 8.5.2(b), (ii) indemnification              under Section 14.2 (to the extent applicable) and (iii) termination of this Agreement              pursuant to Section 6.3 (to the extent applicable, but subject to the applicable cure              periods set forth therein).  In the event that Lilly Compound is lost or damaged after             Delivery, Lilly shall provide additional Lilly Compound to Sponsor, if available for             the Study, provided that Sponsor shall reimburse Lilly for the Direct Manufacturing             Costs and Indirect Manufacturing Costs of such replaced Lilly Compound to the              extent that the loss or damage is due to the negligence of Sponsor or any of its              vendors, subcontractors or Affiliates, and provided further that Lilly shall have no              obligation to provide replacement Lilly Compound for any Lilly Compound              supplied hereunder other than such Lilly Compound as has been agreed or              determined to have a Non-Conformance at the time of Delivery to Sponsor (so long             as such Non-Conformance was discovered within a reasonable time period).              "Direct Manufacturing Costs" shall be calculated consistent with Generally                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 17                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential               Accepted Accounting Principles ("GAAP") and include manufacturing fees, raw              materials, direct labor, freight and duty, and factory overhead costs that can be              directly attributed to the Compound, including but not limited to equipment              maintenance and repair, supplies, ongoing stability program costs, other plan              services, indirect labor and depreciation on direct capital assets. "Indirect              Manufacturing Costs" shall be calculated consistent with GAAP and include              allocations of indirect factory overhead and site support costs, including but not              limited to utilities, quality, planning, engineering, maintenance, safety, site science              and technology, and depreciation on indirect capital assets, procurement,              warehousing, and corporate services.  Allocations shall be based on each              compound's utilization relative to a manufacturing site's total activity.                      (c)   Sponsor shall be responsible for, and Lilly shall have no obligations              or liability with respect to, any Sponsor Compound supplied hereunder that is found              to have a Non-Conformance.  Sponsor shall replace any Sponsor Compound as is              found to have a Non-Conformance (with respect to Sponsor Compound that has not              yet been administered in the course of performing the Study).  Unless otherwise              agreed to by the Parties in writing, the sole and exclusive remedies of Lilly with              respect to any Sponsor Compound that is found to have a Non-Conformance shall              be (i) replacement of such Sponsor Compound as set forth in this Section 8.5.2(c),              (ii) indemnification under Section  14.2 (to the extent applicable) and (iii)              termination of this Agreement pursuant to Section 6.3 (to the extent applicable, but              subject to the applicable cure periods set forth therein).         Section 8.6. Resolution of Discrepancies.  Disagreements regarding any determination  of Non-Conformance by Sponsor shall be resolved in accordance with the provisions of the Quality  Agreement.          Section 8.7. Investigations.  The process for investigations of any Non-Conformance  shall be handled in accordance with the Quality Agreement.         Section 8.8. Shortage; Allocation.  In the event that a Party's Compound is in short  supply as a result of a manufacturing disruption, manufacturing difficulties or other similar event  such that a Party reasonably believes in good faith that it will not be able to fulfill its supply  obligations hereunder with respect to its Compound, such Party will provide prompt written notice  to the other Party thereof (including the shipments of Compound hereunder expected to be  impacted and the quantity of its Compound that such Party reasonably determines it will be able  to supply) and the Parties will promptly discuss such situation (including how the quantity of  Compound that such Party is able to supply hereunder will be allocated within the Study).  In such  event, the Party experiencing such shortage shall (i) use its commercially reasonable efforts to  remedy the situation giving rise to such shortage and to take action to minimize the impact of the  shortage on the Study, and (ii) allocate to the other Party an amount of Compound as is fair and  equitable in such Party's sole discretion.          Section 8.9. Manufacturing Records.  Each Party shall maintain complete and accurate  records in all material respects pertaining to its Manufacture of its Compound supplied hereunder,  and, upon the reasonable prior request of the other Party, will make such records available to                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 18                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    review by such other Party in accordance with the Quality Agreement solely for the purpose of   confirming such Party's compliance with this Agreement with respect to its Manufacturing   obligations hereunder.           Section 8.10. Quality.  Quality matters related to the Manufacture of the Compounds   shall be governed by the terms of the Quality Agreement in addition to the relevant quality   provisions of this Agreement.          Section 8.11. Audits and Inspections.  The Parties' audit and inspection rights under this   Agreement shall be governed by the terms of the Quality and Pharmacovigilance Agreements.          Section 8.12. VAT.  It is understood and agreed between the Parties that any payments   made under this Agreement are exclusive of any value added or similar tax ("VAT"), which shall   be added thereon as applicable.  Where VAT is properly charged by the supplying Party and added  to a payment made under this Agreement, the Party making the payment will pay the amount of  VAT only on receipt of a valid tax invoice from the supplying Party issued in accordance with the  laws and regulations of the country in which the VAT is chargeable.                                     ARTICLE 9.                                CONFIDENTIALITY.            Section 9.1. Treatment of Confidential Information.  Sponsor and Lilly agree to hold   in confidence any Confidential Information of the other Party, and neither Party shall use   Confidential Information of the other Party except for the performance of the Study and for   permitted uses otherwise stated in this Agreement.  Neither Party shall, without the prior written   permission of the other Party, disclose any Confidential Information of the other Party to any Third   Party except to the extent disclosure (i) is required by Applicable Law; (ii) is pursuant to the terms   of this Agreement; or (iii) is necessary for the conduct of the Study, and in each case ((i) through   (iii)) provided that the disclosing Party shall provide reasonable advance notice to the other Party   before making such disclosure.  For the avoidance of doubt, Sponsor may, without Lilly's consent,   disclose Confidential Information to clinical trial sites and clinical trial investigators performing   the Study, the data safety monitoring and advisory board relating to the Study, and Regulatory   Authorities working with Sponsor on the Study, in each case to the extent necessary for the   performance of the Study, in compliance with Applicable Law, and provided that such persons   (other than governmental entities) are bound by an obligation of confidentiality at least as stringent   as the obligations contained herein.  Either party may, without the other party's consent, disclose,   to the extent requested, relevant and applicable, Confidential Information to any national, federal,   state, local or foreign governmental, regulatory or administrative authority, agency, department or   arbitral body of any country having responsibility for the imposition of any tax in connection with   an audit or examination of any tax return.          Section 9.2. Jointly Owned Confidential Information.  [***]                     9.2.1  Sponsor shall have the right to (i) use jointly owned Confidential              Information [***]; and                                       CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 19                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential                    9.2.2  Lilly shall have the right to (i) use jointly owned Confidential             Information [***].         Section 9.3. Disclosure of Confidential Information.  Subject to Section 3.6, Lilly may  use and disclose to Third Parties any Lilly solely owned Confidential Information for any purpose  without obligation or accounting to Sponsor.  Subject to Section 3.6, Sponsor may use and disclose  to Third Parties any Sponsor solely owned Confidential Information for any purpose without  obligation or accounting to Lilly.         Section 9.4. Confidential Information with PHI.  Confidential Information containing  personal identifiable data shall be handled in accordance with all applicable data protection and  privacy laws, rules and regulations applicable to such Party, including the EU General Data  Protection Regulation and HIPAA, to the extent and as applicable.                                   ARTICLE 10.                           INTELLECTUAL PROPERTY.           Section 10.1. Joint Ownership and Prosecution.                    10.1.1 Subject to Section 10.2 and Section 10.3, all rights to all Inventions             relating to or covering the [***] (each a "Jointly Owned Invention") shall belong             jointly to Sponsor and Lilly.  For those countries where a specific license is required             for a joint owner of a Jointly Owned Invention to exploit such Jointly Owned             Invention in such countries, (i) [***].  For clarity, the terms of this Agreement do             not provide Sponsor or Lilly with any rights, title or interest or any license to the             other Party's background intellectual property except as necessary to conduct the             Study and as expressly set forth in this Agreement.  Each Party shall have the right             to freely exploit each Jointly Owned Invention, both within and outside the scope of             the Study, without accounting to or any other obligation to the other Party, and each             Party may grant licenses (with a right to sublicense) to Third Parties under such             Party's interest in each Jointly Owned Invention.                    10.1.2 As needed following the Effective Date, patent representatives of             each of the Parties shall meet (in person or by telephone) to discuss the patenting             strategy for any Jointly Owned Inventions that may arise.  In particular, the Parties             shall discuss which Party will file a patent application (including any provisional,             substitution, divisional, continuation, continuation in part, reissue, renewal,             reexamination, extension, supplementary protection certificate and the like) in             respect of any Jointly Owned Invention (each, a "Joint Patent Application") [***].              In any event, the Parties shall consult and reasonably cooperate with one another in             the preparation, filing, prosecution (including prosecution strategy) and             maintenance of such patent application and shall equally share the expenses             associated with the Joint Patent Applications.  In the event that one Party (the "Filing             Party") wishes to file a patent application for a Jointly Owned Invention and the             other Party (the "Non-filing Party") does not want to file any patent application for             such Jointly Owned Invention or does not want to file in a particular country, the             Non-filing Party shall execute such documents and perform such acts at the Filing                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 20                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential              Party's expense as may be reasonably necessary to effect an assignment of such             Jointly Owned Invention to the Filing Party (in such country or all countries, as             applicable) in a timely manner to allow the Filing Party to prosecute such patent             application.  Likewise, if a Party (the "Opting-out Party") wishes to discontinue the             prosecution and maintenance of a Joint Patent Application, the other Party, at its sole             option (the "Continuing Party"), may continue such prosecution and maintenance.              In such event, the Opting-out Party shall execute such documents and perform such             acts at the Continuing Party's expense as may be reasonably necessary to effect an             assignment of such Joint Patent Application to the Continuing Party (in such country             or all countries, as applicable) in a timely manner to allow the Continuing Party to             prosecute and maintain such patent application.  [***].                     10.1.3 Except as expressly provided in Section 10.1.1 and in furtherance             and not in limitation of Section 9.1, each Party agrees to make no patent application             based on the other Party's Confidential Information, and to give no assistance to any             Third Party for such application, without the other Party's prior written             authorization.                    10.1.4 Sponsor shall have the first right to initiate legal action to enforce             all Joint Patents against infringement, and to protect all Jointly Owned Inventions             from misappropriation, by any Third Party [***], or to defend any declaratory             judgment action relating thereto, at its sole expense (subject to Section 10.1.5).  In             the event that Sponsor fails to initiate or defend such action within [***] days after             being first notified of such infringement or misappropriation, Lilly shall have the             right to do so at its sole expense (subject to Section 10.1.5).  Similarly, Lilly shall             have the first right to initiate legal action to enforce all Joint Patents against             infringement and to protect all Jointly Owned Inventions from misappropriation, by             any Third Party [***], or to defend any declaratory judgment action relating thereto,             at its sole expense (subject to Section 10.1.5).  In the event that Lilly fails to initiate             or defend such action within [***] days after being first notified of such             infringement, Sponsor shall have the right to do so at its sole expense (subject to             Section 10.1.5).  In the event that legal action to enforce [***], the Parties shall work             together to coordinate such action and shall share the costs and expenses of such             litigation equally.  For clarity, if the alleged infringer is selling or intending to sell             only one of either a Sponsor Class Compound or a Lilly Class Compound, then the             Parties obligation to share the costs and expenses of such litigation shall not apply.                     10.1.5 If one Party brings any prosecution or enforcement action or             proceeding against a Third Party [***].  Any damages or other monetary awards             recovered shall be shared by the Parties in proportion based on their relative             contributions to the total costs and expenses of the litigation.  A settlement or consent             judgment or other voluntary final disposition of a suit under this Section 10.1.5 may             not be entered into without the consent of the Party not bringing the suit, which shall             not be unreasonable withheld, conditioned or delayed.          Section 10.2. Inventions Owned by Sponsor.  Notwithstanding Section 10.1, the Parties  agree that all rights to Inventions relating solely to the Sponsor Compound are the exclusive                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 21                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential   property of Sponsor.  Sponsor shall be entitled to file in its own name relevant patent applications  and to own resultant patent rights for any such Invention.  For the avoidance of doubt, any  Invention generically encompassing the Sponsor Compound (and not any Lilly proprietary  compound including the Lilly Compound) within its scope, even where the Sponsor Compound is  not disclosed per se, is the exclusive property of Sponsor.         Section 10.3. Inventions Owned by Lilly.  Notwithstanding Section 10.1, the Parties  agree that all rights to Inventions relating solely to the Lilly Compound are the exclusive property  of Lilly.  Lilly shall be entitled to file in its own name relevant patent applications and to own  resultant patent rights for any such Invention.  For the avoidance of doubt, any Invention  generically encompassing the Lilly Compound (and not any Sponsor proprietary compound  including the Sponsor Compound) within its scope, even where the Lilly Compound is not  disclosed per se, is the exclusive property of Lilly.         Section 10.4. Mutual Freedom to Operate for Combination Inventions.                      10.4.1 Sponsor hereby grants to Lilly a non-exclusive, worldwide, royalty-            free, fully paid-up license, transferable and sublicensable, [***].                    10.4.2 Lilly hereby grants to Sponsor a non-exclusive, worldwide, royalty-            free, fully paid-up license, transferable and sublicensable, [***].                     10.4.3 For clarity, the terms of this Section 10.4 do not provide Lilly or             Sponsor with any rights, title or interest or any license to the other Party's             background intellectual property which does not claim the Combination (i.e.,             intellectual property owned or licensed by either Party which does not constitute an             Invention and does not claim the Combination) except as necessary to conduct the             Study.                                   ARTICLE 11.                 REPRINTS AND RIGHTS OF CROSS-REFERENCE.           Consistent with applicable copyright and other laws, each Party may use, refer to, and  disseminate reprints of scientific, medical and other published articles and materials from journals,  conferences and/or symposia relating to the Study which disclose the name of a Party, provided  such use does not constitute an endorsement of any commercial product or service by the other  Party.                                  ARTICLE 12.                     PRESS RELEASES AND PUBLICATIONS.           Section 12.1. Public Announcements.  Unless otherwise required by Applicable Law,  neither Party shall make any public announcement concerning this Agreement without the prior  written consent of the other Party.  Notwithstanding the foregoing, Lilly acknowledges that  information related to the Agreement may be material information with respect to Sponsor and  require disclosure under applicable SEC rules or other Applicable Law. Such required disclosures  shall not be considered a breach of this Section 12.1.  To the extent a Party desires to make a public  announcement in relation to this Agreement or the Study (including any press release, earnings                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 22                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    call release, or investor presentation that contain data updates regarding the study), such Party shall  provide the other Party with a draft thereof at least [***] Business Days prior to the date on which  such Party intends to make the public announcement; the other Party shall review the draft within  such time period and provide any comments, which the Party seeking to make the disclosure shall  review in good faith. Lilly acknowledges the Sponsor of the Study’s interest in providing periodic  updates regarding Study and shall not unreasonably withhold, condition or delay consent for public   announcements requested by Sponsor. In addition, Lilly agrees that Sponsor may provide   enrollment updates regarding the study without prior consent.  In addition, the parties hereby agree   to work together in good faith to approve a press release that may be published following the   execution of this Agreement.            Section 12.2. Registration of Clinical Trial.  To the extent required by Applicable Law   or as reasonably requested by Lilly, Sponsor will register the Study with the Clinical Trials   Registry located at www.clinicaltrials.gov.  Sponsor is committed to timely publication of the   results following Study Completion, after taking appropriate action to secure intellectual property   rights (if any) arising from the Study.  The publication of the results of the Study will be in  accordance with the Protocol.  Lilly agrees not to publish any results of the Study prior to the  timely publication of such Study results by Sponsor; the Parties agree that publication within [***]  of Study Completion is timely publication.            Section 12.3. Publication.  Subject to Section 12.2, each Party shall use commercially   reasonable efforts to publish or present scientific papers dealing with the Study in accordance with  accepted scientific practice.  Each Party may issue a press release related to any scientific  presentation or publication regarding the Study in a form mutually agreed to by the Parties.           Section 12.4. Review of Materials.  The Parties agree that prior to submission of the   results of the Study for publication or presentation or any other dissemination of results including   oral dissemination, the publishing Party shall invite the other to comment on the content of the   material to be published or presented according to the following procedure:                      12.4.1 At least [***] days prior to submission for publication of any paper,              letter, abstract, poster, talk or any other presentation or publication, the publishing              Party shall provide to the other Party the initial draft of the proposed publication or              presentation in an electronic version.  During the [***] day period, the publishing              Party and the other Party shall work together in good faith in order to allow for all              actions to be taken to preserve rights for patent protection.  At least [***] days prior              to submission for presentation of any abstract, poster, talk or any other presentation              and at least [***] days prior to submission of any paper, letter, or publication, the              publishing Party shall provide to the other Party the full draft of the proposed              presentation or publication for review and comment.                        12.4.2 The publishing Party shall give reasonable consideration to any              request by the other Party made within the periods mentioned in this Section 12.4 to              modify the publication and the Parties shall work in good faith and in a timely              manner to resolve any issue regarding the content for publication.                                       CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 23                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential                    12.4.3 The publishing Party shall remove all Confidential Information of             the other Party before finalizing the publication.         Section 12.5. Acknowledgments.  Each Party agrees to identify and acknowledge the  other Party's support in any press release and any other publication or presentation of the results  of the Study.                                    ARTICLE 13.        GENERAL REPRESENTATIONS AND WARRANTIES; DISCLAIMERS.           Section 13.1. General Representations.  Each of Sponsor and Lilly represents and  warrants to the other that:                    13.1.1 it is a corporation duly organized, validly existing, and in good             standing under the laws of its jurisdiction of formation;                    13.1.2 it has full corporate power and authority to execute, deliver, and             perform this Agreement, and has taken all corporate action required by law and its             organizational documents to authorize the execution and delivery of this Agreement             and the consummation of the transactions contemplated by this Agreement;                    13.1.3 this Agreement constitutes a valid and binding agreement             enforceable against it in accordance with its terms;                     13.1.4 all consents, approvals and authorizations from all governmental             authorities or other Third Parties required to be obtained by such Party in connection             with this Agreement have been obtained; and                    13.1.5 the execution and delivery of this Agreement and all other             instruments and documents required to be executed pursuant to this Agreement, and             the consummation of the transactions contemplated hereby do not and will not (i)             conflict with or result in a breach of any provision of its organizational documents,             (ii) result in a breach of any agreement to which it is a party; or (iii) violate any law.         Section 13.2. No Guaranteed Results.  Neither Party undertakes that the Study shall lead  to any particular result and both Parties agree and understand that the success of the Study is not  guaranteed.  Neither Party accepts any responsibility for any use of the Clinical Data by the other  Party nor for advice or information given in connection therewith.         Section 13.3. Anti-Corruption.                      13.3.1 In performing their respective obligations hereunder, the Parties             acknowledge that the corporate policies of Sponsor and Lilly and their respective             Affiliates require that each Party's business be conducted within the letter and spirit             of Applicable Law.  By signing this Agreement, each Party agrees to conduct the             business contemplated herein in a manner which is consistent with Applicable Law,             including the U.S. Foreign Corrupt Practices Act of 1977 (as amended, the "FCPA")             and any laws enacted to implement the Organization of Economic Cooperation and                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 24                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential              Development Convention on Combating Bribery of Foreign Officials in             International Business Transactions and good business ethics, and its ethics and             other corporate policies, and to abide by the spirit of the other Party's applicable             ethics and compliance guidelines which may be provided by such other Party from             time to time.               Specifically, each Party agrees that it and its Affiliates, and its and its Affiliates'        directors, employees, officers, and anyone acting on its behalf, in connection with the        performance of this Agreement, have not made, offered, given, promised to give,        authorized, ratified, offered to make or taken any action in furtherance of, and will not,        directly or indirectly, make, offer, promise to give, authorize, ratify or offer to make, or        take any action in furtherance of, any payment or transfer of anything of value to any person        or to any Government Official to do or omit to do an act in violation of a lawful or otherwise        required duty or for the purpose of securing any improper advantage or inducing the person        or Government Official to improperly influence the act or decision of any organization,       including any government or government instrumentality, to assist Lilly or Sponsor in       obtaining or retaining business.                     13.3.2 Each Party shall not contact, or otherwise knowingly meet with, any             Government Official for the purpose of discussing activities arising out of or in             connection with this Agreement, without the prior written approval of the other             Party, except where such meeting is consistent with the purpose and terms of this             Agreement and in compliance with Applicable Law.                    13.3.3 Each Party represents that:  (i) it has no impediment to enter into the             transaction contemplated in this Agreement; (ii) it is not excluded, debarred,             suspended, proposed for suspension or debarment, or otherwise ineligible for             government programs; and (iii) no individual involved in the Study has been             debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and             Cosmetic  Act  (21  U.S.C.  335a)  and  no  Person  on  any  of  the  FDA  clinical             investigator enforcement lists (including, but not limited to, the (1)             Disqualified/Totally  Restricted  List,  (2)  Restricted  List  and  (3) Adequate             Assurances List) is involved in the Study or any other activity with respect to a             Compound;                    13.3.4 Each Party represents and warrants that except as disclosed to the             other in writing prior to the commencement of this Agreement:  (i) it does not have             any interest which directly or indirectly conflicts with its proper and ethical             performance of this Agreement; (ii) it shall maintain arm's length relations with all             Third Parties with which it deals for or on behalf of the other in performance of this             Agreement; and (iii) it has provided complete and accurate information to the other             Party in the course of negotiating this Agreement, including disclosure of any             officers, employees, owners or persons directly or indirectly retained by such Party,             if any, in relation to the performance of this Agreement who are Government             Officials or relatives of Government Officials.  Each Party shall make all further             disclosures as necessary to the other Party to ensure the information provided             remains complete and accurate throughout the term of this Agreement.  Subject to                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 25                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential              the foregoing, each Party agrees that it shall not hire or retain any Government             Official to assist in its performance of this Agreement, with the sole exception of             conduct of or participation in clinical trials under this Agreement, provided that such             hiring or retention shall be subject to the completion by the hiring or retaining Party             of a satisfactory anti-corruption and bribery (e.g., FCPA) due diligence review of             such Government Official.  Each Party further covenants that any future information             and documentation submitted to the other Party as part of further due diligence or a             certification shall be complete and accurate.                     13.3.5 Each Party shall have the right during the term of this Agreement,             and for a period of [***] following termination of this Agreement, to conduct an             investigation and audit of the other Party's activities, books and records, to the extent             they relate to that other Party's performance under this Agreement, to verify             compliance with the terms of this Section 13.3.  Such other Party shall cooperate             fully with such investigation or audit, the scope, method, nature and duration of             which shall be at the sole reasonable discretion of the Party requesting such audit.                     13.3.6 Each Party shall ensure that all transactions under the Agreement             are properly and accurately recorded in all material respects on its books and records             and that each document upon which entries in such books and records are based is             complete and accurate in all material respects.  Each Party further represents,             warrants and covenants that all books, records, invoices and other documents             relating to payments and expenses under this Agreement are and shall be complete             and accurate and reflect in reasonable detail the character and amount of transactions             and expenditures.  Each Party must maintain a system of internal accounting controls             reasonably designed to ensure that no off-the-books or similar funds or accounts will             be maintained or used in connection with this Agreement.                     13.3.7 Each Party agrees that in the event that the other Party believes in             good faith that there has been a possible violation of any provision of Section 13.3,             such other Party may make full disclosure of such belief and related information             needed to support such belief at any time and for any reason to any competent             government bodies and its agencies, and to whoever such Party determines in good             faith has a legitimate need to know.                    13.3.8 Each Party agrees to ensure that all employees performing its             obligations under this Agreement are provided ethics and compliance training in             accordance with such Party's corporate policies and procedures.         Section 13.4. Compliance.                      13.4.1 Compliance with Party Specific Regulations.  The Parties agree to             cooperate with each other as may reasonably be required to ensure that each is able             to fully meet its obligations with respect to the Party Specific Regulations applicable             to it.  Neither Party shall be obligated to pursue any course of conduct that would             result in such Party being in material breach of any Party Specific Regulation                                     CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 26                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential              applicable to it.  All Party Specific Regulations are binding only in accordance with             their terms and only upon the Party to which they relate.                       13.4.2 Compliance with Internal Compliance Codes.  All Internal             Compliance Codes shall apply only to the Party to which they relate.  The Parties             agree to cooperate with each other to ensure that each Party is able to comply with             the substance of its respective Internal Compliance Codes and, to the extent             practicable, to operate in a manner consistent with its usual Compliance related             processes. "Internal Compliance Codes" shall mean a Party's internal policies and             procedures intended to ensure that a Party complies with Applicable Laws, Party             Specific Regulations, and such Party's internal ethical, medical and similar standard.             "Party Specific Regulations" shall mean all judgments, decrees, orders or similar             decisions issued by any Governmental Authority specific to a Party, and all consent             decrees, corporate integrity agreements, or other agreements or undertakings of any             kind by a Party with any Governmental Authority, in each case as the same may be             in effect from time to time and applicable to a Party's activities contemplated by this             Agreements.          Section 13.5. NO OTHER REPRESENTATIONS AND WARRANTIES.  EXCEPT  AS EXPRESSLY PROVIDED HEREIN, LILLY MAKES NO WARRANTIES, EXPRESS OR  IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A  PARTICULAR PURPOSE, WITH RESPECT TO THE LILLY COMPOUND, AND SPONSOR  MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF  MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO  THE SPONSOR COMPOUND.                                   ARTICLE 14.          INSURANCE; INDEMNIFICATION; LIMITATION OF LIABILITY.           Section 14.1. Insurance.  Each Party warrants that it maintains a policy or program of  insurance or self-insurance at levels sufficient to support the indemnification obligations assumed  herein with carriers rated A-VII or better with A. M. Best or like rating agencies.  Upon request, a  Party shall provide evidence of such insurance.  At a minimum each party will procure and  maintain or at its option, satisfy, in whole or in part through its self- insurance program:                    14.1.1 Workers' Compensation accordance with applicable statutory             requirements and will provide a waiver of subrogation in favor of the other party;                    14.1.2 Employer's Liability with a limit of liability in an amount of not less             than [***];                    14.1.3 Commercial General Liability for premises/ongoing operations in             an amount not less than [***];         Section 14.2. Indemnification.                      14.2.1 Indemnification by Sponsor.  Sponsor agrees to defend, indemnify             and hold harmless Lilly, its Affiliates, and its and their employees, directors,                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 27                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential              subcontractors and agents from and against any loss, damage, reasonable costs and             expenses (including reasonable attorneys' fees and expenses) incurred in connection             with any claim, proceeding, or investigation by a Third Party arising out of this             Agreement or the Study (a "Liability"), except to the extent that such Liability (A)             was directly caused by (i) negligence or willful misconduct on the part of Lilly (or             any of its Affiliates, or its and their employees, directors, subcontractors or agents);             (ii) a breach on the part of Lilly of any of its representations and warranties or any             other covenants or obligations of Lilly under this Agreement; or (iii) a breach of             Applicable Law by Lilly; or (B) is determined to be attributable to the Lilly             Compound.                    14.2.2 Indemnification by Lilly.  Lilly agrees to defend, indemnify and             hold harmless Sponsor, its Affiliates, and its and their employees, directors,             subcontractors and agents from and against any Liability except to the extent that             such Liability (A) was directly caused by (i) negligence or willful misconduct on the             part of Sponsor (or any of its Affiliates, or its and their employees, directors,             subcontractors or agents); (ii) a breach on the part of Sponsor of any of its             representations and warranties or any other covenants or obligations of Sponsor             under this Agreement; or (iii) a breach of Applicable Law by Sponsor; or (B) is             determined to be attributable to the Sponsor Compound.                    14.2.3 Procedure.  The obligations of Lilly and Sponsor under this Section             14.2 are conditioned upon the delivery of written notice to Lilly or Sponsor, as the             case might be, of any potential Liability within a reasonable time after a Party             becomes aware of such potential Liability.  A Party will have the right to assume the             defense of any suit or claim related to the Liability (using counsel reasonably             satisfactory to the other Party) if it has assumed responsibility for the suit or claim             in writing.  The other Party may participate in (but not control) the defense thereof             at its sole cost and expense.  The Party controlling such defense (the "Defending             Party") shall keep the other Party (the "Other Party") advised of the status of such             action, suit, proceeding or claim and the defense thereof and shall consider             recommendations made by the Other Party with respect thereto.  The Defending             Party shall not agree to any settlement of such action, suit, proceeding or claim             without the prior written consent of the Other Party, which shall not be unreasonably             withheld.  The Defending Party shall not agree to any settlement of such action, suit,             proceeding or claim or consent to any judgment in respect thereof that does not             include a complete and unconditional release of the Other Party from all liability             with respect thereto or that imposes any liability or obligation on the Other Party             without the prior written consent of the Other Party.         Section 14.3. Study Subjects.  Sponsor shall not offer compensation on behalf of Lilly to  any Study subject or bind Lilly to any indemnification obligations in favor of any Study subject.   Likewise, Lilly shall not offer compensation on behalf of Sponsor to any Study subject or bind  Sponsor to any indemnification obligations in favor of any Study subject.         Section 14.4. LIMITATION OF LIABILITY.  OTHER THAN WITH RESPECT TO  DAMAGES ARISING OUT OF OR RELATED TO A PARTY'S BREACH OF ITS                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 28                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential    OBLIGATIONS UNDER THIS AGREEMENT TO USE, DISCLOSE, LICENSE, ASSIGN OR   OTHERWISE TRANSFER SAMPLE TESTING RESULTS, CLINICAL DATA,   CONFIDENTIAL INFORMATION AND JOINTLY-OWNED INVENTIONS ONLY FOR THE   PERMITTED USE, IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES   OR SUBCONTRACTORS) BE LIABLE TO THE OTHER PARTY FOR, NOR SHALL ANY   INDEMNIFIED PARTY HAVE THE RIGHT TO RECOVER, ANY SPECIAL, INDIRECT,   INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING LOST   PROFITS OR DAMAGES FOR LOST OPPORTUNITIES), WHETHER IN CONTRACT,   WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT   OF (x) THE MANUFACTURE OR USE OF ANY COMPOUND SUPPLIED HEREUNDER OR   (y) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS   AGREEMENT OR ANY REPRESENTATION, WARRANTY OR COVENANT CONTAINED   IN OR MADE PURSUANT TO THIS AGREEMENT, EXCEPT THAT SUCH LIMITATION   SHALL NOT APPLY TO DAMAGES PAID OR PAYABLE TO A THIRD PARTY BY AN   INDEMNIFIED PARTY FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO   INDEMNIFICATION HEREUNDER.                                    ARTICLE 15.                                 MISCELLANEOUS            Section 15.1. Use of Name.  Except as expressly provided herein, neither Party shall have   any right, express or implied, to use in any manner the name or other designation of the other Party   or any other trade name, trademark or logo of the other Party for any purpose in connection with   the performance of this Agreement.          Section 15.2. Force Majeure.  If in the performance of this Agreement, one of the Parties   is prevented, hindered or delayed by reason of any cause beyond such Party's reasonable control   (e.g., war, riots, fire, strike, governmental laws), such Party shall be excused from performance to   the extent that it is necessarily prevented, hindered or delayed ("Force Majeure").  The non-  performing Party will notify the other Party of such Force Majeure within [***] days after such  occurrence by giving written notice to the other Party stating the nature of the event, its anticipated  duration, and any action being taken to avoid or minimize its effect.  The suspension of  performance will be of no greater scope and no longer duration than is necessary and the non- performing Party will use commercially reasonable efforts to remedy its inability to perform.           Section 15.3. Entire Agreement; Modification.  The Parties agree to the full and   complete performance of the mutual covenants contained in this Agreement.  This Agreement,   together with the Related Agreements, constitutes the sole, full and complete agreement by and   between the Parties with respect to the subject matter of this Agreement, and all prior agreements,   understandings, promises and representations, whether written or oral, with respect thereto are   superseded by this Agreement.  No amendments, changes, additions, deletions or modifications to   or of this Agreement shall be valid unless reduced to writing and signed by the Parties hereto.  In  the event of a conflict between this Agreement, the Pharmacovigilance Agreement or the exhibits  and appendices attached hereto, the Pharmacovigilance Agreement shall control with respect to  pharmacovigilance matters.  For avoidance of doubt, the Quality Agreement shall control in the  event of a conflict between this Agreement and the Quality Agreement with respect to quality  matters.                                     CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 29                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential          Section 15.4. Assignment and Sub-Contracting.  Neither Party shall assign or transfer   this Agreement without the prior written consent (which shall not be unreasonably withheld,   conditioned or delayed) of the other Party; provided, however, that either Party may assign all or  any part of this Agreement to one or more of its Affiliates without the other Party's consent, and   any and all rights and obligations of either Party may be exercised or performed by its Affiliates,   provided that such Affiliates agree to be bound by this Agreement and such Party shall be jointly   and severally liable for such Affiliate’s compliance with the terms of this Agreement and Related   Agreements.            Section 15.5. Invalid Provision.  If any provision of this Agreement is held to be illegal,   invalid or unenforceable, the remaining provisions shall remain in full force and effect and will   not be affected by the illegal, invalid or unenforceable provision.  In lieu of the illegal, invalid or   unenforceable provision, the Parties shall negotiate in good faith to agree upon a reasonable   provision that is legal, valid and enforceable to carry out as nearly as practicable the original   intention of the entire Agreement.          Section 15.6. No Additional Obligations.  Sponsor and Lilly have no obligation to renew   this Agreement or apply this Agreement to any clinical trial other than the Study.  Neither Party is   under any obligation to enter into another type of agreement at this time or in the future.          Section 15.7. Dispute Resolution and Jurisdiction.                       15.7.1 The Parties shall attempt in good faith to settle all disputes arising              out of or in connection with this Agreement in an amicable manner through the              Project Managers.  Any claim, dispute or controversy arising out of or relating to              this Agreement, including the breach, termination or validity hereof or thereof (each,              a "Dispute"), shall be governed by and construed in accordance with the substantive              laws of the State of New York, without giving effect to its choice of law principles.                      15.7.2 Nothing contained in this Agreement shall deny either Party the              right to seek injunctive or other equitable relief from a court of competent              jurisdiction in the context of a bona fide emergency or prospective irreparable harm,              and such an action may be filed or maintained notwithstanding any ongoing              discussions between the Parties.           Section 15.8. Notices.  All notices or other communications that are required or permitted   hereunder shall be in writing and delivered personally, sent by facsimile or email, as applicable,   (and promptly confirmed by personal delivery or overnight courier), or sent by internationally   recognized overnight courier addressed as follows:          If to Lilly, to:  Eli Lilly & Company                           Lilly Corporate Center                           893S. Delaware                           Indianapolis, IN, USA 46285                           Attention:  VP of Oncology Late Phase Development                           Facsimile No:  (317) 277-3652                                       CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 30                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

 Confidential          With a copy to:   Eli Lilly & Company                           Lilly Corporate Center                           893S. Delaware                           Indianapolis, IN, USA 46285                           Attention:  General Counsel                           Facsimile No: (317) 433-3000          If to Sponsor, to: Pieris Pharmaceuticals, Inc.                           255 State Street, 9th floor                           Boston, MA 02109                           Attention:  SVP, Head of Clinical Development                           [***]                                             With a copy to:   Pieris Pharmaceuticals, Inc.                           255 State Street, 9th floor                           Boston, MA 02109                           Attention:  General Counsel                           [***]                  Section 15.9. Relationship of the Parties.  The relationship between the Parties is and   shall be that of independent contractors, and does not and shall not constitute a partnership, joint   venture, agency or fiduciary relationship.  Neither Party shall have the authority to make any   statements, representations or commitments of any kind, or take any actions, which are binding on   the other Party, except with the prior written consent of the other Party to do so.  All persons   employed by a Party will be the employees of such Party and not of the other Party and all costs   and obligations incurred by reason of any such employment shall be for the account and expense   of such Party.          Section 15.10. Counterparts and Due Execution.  This Agreement, any amendment and   Related Agreements may be executed  in  two  (2)  or  more  counterparts  (including  by  way  of   facsimile or electronic transmission), each of which shall be deemed an original, but all of which   together shall constitute one and the same instrument, notwithstanding any electronic transmission,   storage and printing of copies of this Agreement from computers or printers.  When executed by   the Parties, this Agreement shall constitute an original instrument, notwithstanding any electronic   transmission, storage and printing of copies of this Agreement from computers or printers.  For   clarity, facsimile signatures and signatures transmitted via PDF shall be treated as original   signatures.          Section 15.11. Condition Precedent.  This Agreement will enter into force as of the   Effective Date, but will remain conditional upon the parties negotiating and delivering the Related   Agreements, signed by all required authorized quality officers and representatives of both parties.          Section 15.12. Construction.  Except where the context otherwise requires, wherever   used, the singular will include the plural, the plural the singular, the use of any gender will be   applicable to all genders, and the word "or" is used in the inclusive sense (and/or).  Whenever this  Agreement refers to a number of days, unless otherwise specified, such number refers to calendar                                     CONFIDENTIAL                          Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                       Page 31                                             [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not   material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential   days.  The captions of this Agreement are for convenience of reference only and in no way define,  describe, extend or limit the scope or intent of this Agreement or the intent of any provision  contained in this Agreement.  The term "including" as used herein shall be deemed to be followed  by the phrase "without limitation" or like expression.  The term "will" as used herein means shall.   References to "Article," "Section" or "Appendix" are references to the numbered sections of this  Agreement and the appendices attached to this Agreement, unless expressly stated otherwise.   Except where the context otherwise requires, references to this "Agreement" shall include the  appendices attached to this Agreement.  The language of this Agreement shall be deemed to be the  language mutually chosen by the Parties and no rule of strict construction will be applied against  either Party hereto.                        [Remainder of page intentionally left blank.]                                                    CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 32                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

Confidential         IN WITNESS WHEREOF, the respective representatives of the Parties have executed this  Agreement as of the Effective Date.                                       "SPONSOR"                                                                            PIERIS PHARMACEUTICALS, INC.                                       By: /s/ Stephen Yoder                                                            Name: Stephen Yoder                                                              Title: President & CEO                                                           "LILLY"                                       ELI LILLY AND COMPANY                                       By: /s/ Maura Dickler                                                             Maura Dickler                                        Vice President Oncology Late Phase Development                                       ELI LILLY AND COMPANY                                       By: /s/ Michael Franklin                                                          Michael Franklin                                        Senior Advisor Commercial Product Delivery                                                                            CONFIDENTIAL                         Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                      Page 33                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

                                                                        Appendix A                      [***, 23 pages]                                                                         CONFIDENTIAL                                                        Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                                                            Page 34                                                                                 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competitively harmful if publicly  disclosed. 

 

                                                      Appendix B                                                        [***, 1 page]                                                      CONFIDENTIAL                                  Pieris Study PRS‐343‐PCS_09_20 and Lilly’S ramucirumab                                                       Page 35                                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

                                                      Appendix C   [***, 1 page]                                                      CONFIDENTIAL                                  Pieris Study PRS‐343‐PCS_09_20 and Lilly’S ramucirumab                                                       Page 36                                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

                                                           CONFIDENTIAL                                  Pieris Study PRS‐343‐PCS_09_20 and Lilly’S ramucirumab                                                       Page 37                                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

                                                      Appendix D   [***, 3 pages]                                                      CONFIDENTIAL                                  Pieris Study PRS‐343‐PCS_09_20 and Lilly’S ramucirumab                                                       Page 38                                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed. 

 

                                                       CONFIDENTIAL                                   Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025                                                      Page 39                                                           [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not  material and (II) would be competitively harmful if publicly disclosed.

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