pieris-genentechcollabor






EXHIBIT 10.3    [Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    115115649v.2            Research Collaboration and License  Agreement      This Agreement is entered into with effect as of the Effective Date (as defined below)  by and between  Genentech, Inc.   with offices at 1 DNA Way, South San Francisco, California 94080, US (“Genentech”) on the  one hand  and  Pieris Pharmaceuticals GmbH  with an office and place of business at Zeppelinstrasse 3, 85399 Hallbergmoos, Germany ("Pieris  Hallbergmoos")  and  Pieris Pharmaceuticals, Inc.   with an office and place of business at 255 State Street, 9th Floor, Boston, MA 02109, USA ("Pieris  US"; Pieris Hallbergmoos and Pieris US collectively referred to as “Pieris”)  on the other hand.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 2 -  Table of Contents  1. Definitions .............................................................................................................................. 7  1.1 Affiliate ......................................................................................................................... 7  1.2 Agreement ................................................................................................................... 8  1.3 Agreement Term ......................................................................................................... 8  1.4 Anticalin ....................................................................................................................... 8  1.5 Anticalin Affinity Maturation ......................................................................................... 8  1.6 Anticalin Expression .................................................................................................... 8  1.7 Anticalin Libraries ........................................................................................................ 8  1.8 Anticalin Selection ....................................................................................................... 8  1.9 Applicable Law ............................................................................................................ 9  1.10 Availability ................................................................................................................... 9  1.11 Binder .......................................................................................................................... 9  1.12 Binder IP ...................................................................................................................... 9  1.13 Biosimilar Product ....................................................................................................... 9  1.14 Calendar Quarter ......................................................................................................... 9  1.15 Calendar Year ........................................................................................................... 10  1.16 Change of Control ..................................................................................................... 10  1.17 Change of Control Group .......................................................................................... 10  1.18 Clinical Study ............................................................................................................. 10  1.19 Collaboration Product ................................................................................................ 10  1.20 Collaboration Product Valid Claim ............................................................................. 10  1.21 Collaboration Target .................................................................................................. 10  1.22 Combination Product ................................................................................................. 10  1.23 Commercially Reasonable Efforts ............................................................................. 11  1.24 Companion Diagnostic .............................................................................................. 11  1.25 Competing Product .................................................................................................... 11  1.26 Compulsory Sublicense ............................................................................................. 11  1.27 Confidential Information ............................................................................................ 11  1.28 Continuation Election Notice ..................................................................................... 12  1.29 Control ....................................................................................................................... 12  1.30 Cover ......................................................................................................................... 12  1.31 Dev Go Decision ....................................................................................................... 12  1.32 Development Event ................................................................................................... 12  1.33 Dollars ....................................................................................................................... 13  1.34 Effective Date ............................................................................................................ 13  1.35 EU ............................................................................................................................. 13  1.36 EU4 ........................................................................................................................... 13  1.37 Expert ........................................................................................................................ 13  1.38 FDA ........................................................................................................................... 13  1.39 FDCA ......................................................................................................................... 13  1.40 Field ........................................................................................................................... 13  1.41 Filing .......................................................................................................................... 13  1.42 First Commercial Sale ............................................................................................... 13  1.43 GLP Tox Study .......................................................................................................... 14  1.44 Governmental Authority ............................................................................................. 14  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 3 -  1.45 Handle ....................................................................................................................... 14  1.46 HSR ........................................................................................................................... 14  1.47 ICD ............................................................................................................................ 14  1.48 IFRS .......................................................................................................................... 14  1.49 IND ............................................................................................................................ 14  1.50 Indication ................................................................................................................... 14  1.51 Initiation ..................................................................................................................... 14  1.52 Insolvency Event ....................................................................................................... 15  1.53 Invention .................................................................................................................... 15  1.54 JRC ........................................................................................................................... 15  1.55 Know-How ................................................................................................................. 15  1.56 LSR Go Decision ....................................................................................................... 15  1.57 NDA ........................................................................................................................... 15  1.58 Net Sales ................................................................................................................... 15  1.59 New IP ....................................................................................................................... 16  1.60 Non-Selected Binder(s) ............................................................................................. 16  1.61 Non-Selected-Binder IP ............................................................................................. 16  1.62 Party .......................................................................................................................... 16  1.63 Patent Rights ............................................................................................................. 16  1.64 Phase I Study ............................................................................................................ 16  1.65 Phase II Study ........................................................................................................... 16  1.66 Phase III Study .......................................................................................................... 16  1.67 Pieris Background IP ................................................................................................. 16  1.68 Pieris Platform Background IP .................................................................................. 17  1.69 Pieris Platform Improvement IP ................................................................................. 17  1.70 Pieris Technology ...................................................................................................... 17  1.71 Qualified Hit ............................................................................................................... 17  1.72 Regulatory Approval .................................................................................................. 17  1.73 Regulatory Authority .................................................................................................. 17  1.74 Research Plan ........................................................................................................... 17  1.75 Roche Group ............................................................................................................. 17  1.76 Royalty Term ............................................................................................................. 18  1.77 Sales ......................................................................................................................... 18  1.78 Screening Failure ...................................................................................................... 18  1.79 Selected Binder ......................................................................................................... 18  1.80 Selected Binder IP ..................................................................................................... 18  1.81 Sublicensee ............................................................................................................... 19  1.82 Substitution Period .................................................................................................... 19  1.83 Target Term ............................................................................................................... 19  1.84 Territory ..................................................................................................................... 19  1.85 Third Party ................................................................................................................. 19  1.86 UK ............................................................................................................................. 19  1.87 US ............................................................................................................................. 19  1.88 Valid Claim ................................................................................................................ 19  1.89 Additional Definitions ................................................................................................. 19  2. Grant of License ................................................................................................................... 21  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 4 -  2.1 Research Licenses .................................................................................................... 21  2.2 Commercial License to Genentech ........................................................................... 21  2.3 Sublicense ................................................................................................................. 21  2.4 License to Pieris after Target Term ........................................................................... 21  3. Research Collaboration ........................................................................................................ 22  4. Diligence and limited Non-Compete ..................................................................................... 25  4.1 In General .................................................................................................................. 25  4.2 Diligence of Genentech in Case of Similar Program ................................................. 25  4.3 Limited non-compete ................................................................................................. 25  4.4 Limits ......................................................................................................................... 25  5. Development ........................................................................................................................ 25  5.1 Development by Genentech ...................................................................................... 25  5.2 Provision of Information ............................................................................................. 26  6. Governance .......................................................................................................................... 26  6.1 Joint Research Committee ........................................................................................ 26  6.2 Members ................................................................................................................... 26  6.3 Responsibilities of the JRC ....................................................................................... 26  6.4 Meetings .................................................................................................................... 27  6.5 Minutes ...................................................................................................................... 27  6.6 Decisions ................................................................................................................... 27  6.7 Information Exchange ............................................................................................... 28  6.8 Alliance Director ........................................................................................................ 28  6.9 Limitations of Authority .............................................................................................. 28  6.10 Expenses ................................................................................................................... 28  6.11 Lifetime and Genentech Reporting Obligations ......................................................... 28  7. Supply .................................................................................................................................. 28  7.1 Supply of Collaboration Product(s) after Target Term ............................................... 28  7.2 Commercial Supply of Collaboration Product(s) ....................................................... 28  7.3 Provision of Information ............................................................................................. 28  8. Regulatory ............................................................................................................................ 29  8.1 Responsibility ............................................................................................................ 29  8.2 Information Exchange ............................................................................................... 29  9. Commercialization ................................................................................................................ 29  9.1 Responsibility ............................................................................................................ 29  10. Payment ........................................................................................................................... 30  10.1 Upfront Fee ............................................................................................................... 30  10.2 Subsequent Target Fee ............................................................................................. 30  10.3 Target Substitution Fee ............................................................................................. 30  10.4 Development Event Payments .................................................................................. 30  10.5 Sales Based Events .................................................................................................. 31  10.6 Royalty Payments ..................................................................................................... 32  10.7 Combination Product ................................................................................................. 33  10.8 Third Party Payments ................................................................................................ 33  10.9 Disclosure of Payments ............................................................................................. 33  11. Accounting and reporting .................................................................................................. 34  11.1 Timing of Payments ................................................................................................... 34  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 5 -  11.2 Late Payment ............................................................................................................ 34  11.3 Method of Payment ................................................................................................... 34  11.4 Currency Conversion ................................................................................................. 34  11.5 Royalties and Sales Reporting .................................................................................. 34  12. Taxes ................................................................................................................................ 34  13. Auditing ............................................................................................................................. 35  13.1 Pieris’ Right to Audit .................................................................................................. 35  13.2 Audit Reports ............................................................................................................. 35  13.3 Over- or Underpayment ............................................................................................. 35  13.4 Duration of Audit Rights ............................................................................................ 35  14. Intellectual Property .......................................................................................................... 36  14.1 Ownership of Pieris Background IP ........................................................................... 36  14.2 Ownership of New IP ................................................................................................. 36  14.3 German Statute on Employee’s Inventions ............................................................... 36  14.4 Prosecution of Patent Rights within Binder IP prior to the end of the Target Term and  the Non-Selected-Binder IP ................................................................................................. 36  14.5 Prosecution of Patent Rights within the Pieris Platform Improvement IP by Pieris ... 36  14.6 Prosecution of Patent Rights within the Selected Binder IP by Genentech .............. 37  14.7 CREATE Act .............................................................................................................. 37  14.8 Defense ..................................................................................................................... 37  14.9 Enforcement .............................................................................................................. 37  14.10 Common Interest Disclosures ................................................................................... 38  14.11 Biosimilar or interchangeable biological products ..................................................... 38  14.12 Patent Term Extensions ............................................................................................ 38  14.13 Inventorship; Exclusive Dispute Resolution Process ................................................ 39  15. Representations and Warranties ...................................................................................... 39  15.1 Third Party Patent Rights .......................................................................................... 39  15.2 Ownership of Patent Rights ....................................................................................... 39  15.3 Inventors .................................................................................................................... 39  15.4 Grants ........................................................................................................................ 39  15.5 Authorization ............................................................................................................. 39  15.6 Validity of Patent Rights ............................................................................................ 40  15.7 Control and Validity of Know-How ............................................................................. 40  15.8 No Claims .................................................................................................................. 40  15.9 No Conflict ................................................................................................................. 40  15.10 No Other Representations ......................................................................................... 40  16. Indemnification ................................................................................................................. 40  17. Liability .............................................................................................................................. 41  17.1 Limitation of Liability .................................................................................................. 41  17.2 Disclaimer .................................................................................................................. 41  17.3 Insurance ................................................................................................................... 42  18. Obligation Not to Disclose Confidential Information ......................................................... 42  18.1 Non-Use and Non-Disclosure .................................................................................... 42  18.2 Permitted Disclosure ................................................................................................. 42  18.3 Press Releases ......................................................................................................... 42  18.4 Publications ............................................................................................................... 43  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 6 -  18.5 Commercial Considerations ...................................................................................... 44  19. Term and Termination ...................................................................................................... 44  19.1 Commencement and Term ........................................................................................ 44  19.2 Termination ............................................................................................................... 44  19.3 Consequences of Termination .................................................................................. 46  19.4 Survival ...................................................................................................................... 47  20. Bankruptcy ........................................................................................................................ 47  21. Miscellaneous ................................................................................................................... 48  21.1 Governing Law .......................................................................................................... 48  21.2 Disputes .................................................................................................................... 48  21.3 HSR ........................................................................................................................... 48  21.4 Assignment ................................................................................................................ 49  21.5 Debarment ................................................................................................................. 49  21.6 Independent Contractor ............................................................................................. 49  21.7 Unenforceable Provisions and Severability ............................................................... 49  21.8 Waiver ....................................................................................................................... 49  21.9 Appendices ................................................................................................................ 49  21.10 Entire Understanding ................................................................................................. 50  21.11 Amendments ............................................................................................................. 50  21.12 Invoices ..................................................................................................................... 50  21.13 Notice ........................................................................................................................ 50    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 7 -  Research Collaboration and License Agreement    WHEREAS, Pieris has access to a proprietary Anticalin® (lipocalin derived) discovery and  manufacturing platform, possesses proprietary technology and intellectual property rights relating  thereto, and is developing certain programs in the area of inhaled biologics to treat respiratory  diseases; and  WHEREAS, Genentech has target biology expertise as well as expertise in the research,  development, manufacture and commercialization of pharmaceutical and diagnostic products;  and  WHEREAS, the Parties wish to combine their respective expertise to develop binders that inhibit  or specifically bind to certain targets using Pieris Technology for application in particular in the  respiratory and ophthalmology therapeutic areas, and the Parties will collaborate from the  beginning of lead identification through a mutually agreeable preclinical research stage set forth  in the Research Plan.  WHEREAS, Genentech wishes to develop for commercialization such binders and explore their  potential applications in various indications; and  WHEREAS, Pieris is willing to grant to Genentech rights to use certain of its intellectual property  rights to make, use, offer for sale, sell and import and export such binders (including Collaboration  Products containing such binders) in the Territory for use in the Field (as such terms are  respectively defined below), as contemplated herein; and  NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this  Agreement and other good and valuable consideration, the receipt and sufficiency of which are  hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as  follows:    1. Definitions  As used in this Agreement, the following terms, whether used in the singular or plural, shall have  the following meanings:    1.1 Affiliate  The term “Affiliate” shall mean any individual, corporation, association or other business entity  that directly or indirectly controls, is controlled by, or is under common control with the Party in  question. As used in this definition of “Affiliate,” the term “control” shall mean the direct or indirect  ownership of more than fifty percent (>50%) of the stock having the right to vote for directors  thereof or the ability to otherwise control the management of the corporation or other business  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 8 -  entity whether through the ownership of voting securities, by contract, resolution, regulation or  otherwise. Anything to the contrary in this paragraph notwithstanding, Chugai Pharmaceutical Co.,  Ltd, a Japanese corporation (“Chugai”) and its subsidiaries shall not be deemed an Affiliate of  Genentech unless Genentech provides written notice to Pieris of its desire to include Chugai as  an Affiliate of Genentech.    1.2 Agreement  The term “Agreement” shall mean this document including any and all appendices and  amendments to it as may be added and/or amended from time to time in accordance with the  provisions of this Agreement.    1.3 Agreement Term  The term “Agreement Term” shall mean the period of time commencing on the Effective Date and,  unless this Agreement is terminated sooner as provided in Article 19, expiring on the date when  no royalty or other payment obligations under this Agreement are or will become due.    1.4 Anticalin   The term “Anticalin” or “Anticalin Protein” shall mean, whether in nucleic acid or protein form, (i)  any lipocalin mutein isolated from the Anticalin Libraries, or (ii) any lipocalin mutein that, in each  case, has been derived (either physically, intellectually or by reverse engineering, in one (1) or  more steps) from any lipocalin mutein referred to in Section (i) of this definition, in each case,  which binds and recognizes a specific target. For the sake of this Section, mutein shall mean a  protein arising as a result of a mutation or a recombinant DNA procedure.    1.5 Anticalin Affinity Maturation  The term “Anticalin Affinity Maturation” shall mean the process of engineering for an Anticalin to  enhance its developability profile, such as increasing binding activities and specificity by  introducing, e.g., one or more amino acid mutations.    1.6 Anticalin Expression  The term “Anticalin Expression” shall mean heterologous expression of an Anticalin in E. coli or  other hosts as may be mutually agreed between the Parties.    1.7 Anticalin Libraries  The term “Anticalin Libraries” shall mean any phage or yeast display library based on (i) the [***]  lipocalin ([***]), (ii) the [***] lipocalin ([***]), or (iii) [***] lipocalin, if applicable. For clarity, as of the  Effective Date, Pieris does not own any Anticalin Library referred to in Section (iii) of this definition  and this Section (iii) only becomes relevant if and when Pieris develops or acquires such Anticalin  Library during the Agreement Term. For further clarity, notwithstanding anything to the contrary  in this Agreement, Pieris has no obligation to develop or acquire any such Anticalin Library during  the Agreement Term.    1.8 Anticalin Selection  The term “Anticalin Selection” shall mean the process of screening an Anticalin Library with a  defined target through the process of phage display, within a solution, and physically separating  the target, containing binding Anticalins, from the solution containing non-binding Anticalins.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 9 -    1.9 Applicable Law  The term “Applicable Law” shall mean any law, statute, ordinance, code, rule or regulation that  has been enacted by a government authority (including without limitation, any Regulatory  Authority and the United States Securities and Exchange Commission (“SEC”)) and is in force as  of the Effective Date or come into force during the Agreement Term, in each case to the extent  that the same are applicable to the performance by the Parties of their respective obligations  under this Agreement.    1.10 Availability  The term “Availability” or “Available” shall mean that a given target nominated by Genentech as  set forth in Section 3 is, at the time of receipt of the written request from Genentech by Pieris, not  subject to (i) a written license agreement with a Third Party under Pieris Background IP, or (ii) an  active internal program at Pieris, meaning that (A) such target has been designated (and  documented as such) as part of an active program through Pieris’ governance processes, (B)  Pieris has initiated in the laboratory and continued a screening campaign for more than two (2)  months with respect to such Target, and (C) such program is still currently active.    1.11 Binder  The term “Binder” shall mean an Anticalin or Anticalin Protein discovered under the Research  Plan that specifically binds to a Collaboration Target.     1.12 Binder IP   The term “Binder IP” means (a) all Know-How generated by or on behalf of either party after the  Effective Date in the course of performing activities under this Agreement Covering any Binder;  and (b) any Patent Rights claiming the foregoing Know-How in Section 1.12(a) Covering any  Binder, but in each case specifically excludes the Pieris Platform Improvement IP and the Pieris  Background IP.    1.13 Biosimilar Product  The term “Biosimilar Product” shall mean a product that is not produced, licensed or owned by  the Roche Group and is, according to the relevant Regulatory Authority for the given country or  jurisdiction, highly similar with respect to a given Collaboration Product, notwithstanding minor  differences in clinically inactive components, and with no clinically meaningful differences  between the Biosimilar Product and the given Collaboration Product in terms of the safety, purity  and potency of the product.    For countries or jurisdictions where no explicit biosimilar regulations exist, Biosimilar Product  includes products which (i) have been deemed to be a Biosimilar Product by a Regulatory  Authority in another country or jurisdiction or (ii) have the identical amino acid sequence.    1.14 Calendar Quarter  The term “Calendar Quarter” shall mean each period of three (3) consecutive calendar months,  ending March 31, June 30, September 30, and December 31.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 10 -  1.15 Calendar Year  The term “Calendar Year” shall mean the period of time beginning on January 1 and ending  December 31, except for the first year which shall begin on the Effective Date and end on  December 31.    1.16 Change of Control  The term “Change of Control” shall mean, with respect to a Party: (a) the acquisition by any Third  Party of beneficial ownership of fifty percent (50%) or more of the then outstanding common  shares or voting power of such Party, other than acquisitions by employee benefit plans  sponsored or maintained by such Party; (b) the consummation of a business combination  involving such Party, unless, following such business combination, the stockholders of such Party  immediately prior to such business combination beneficially own directly or indirectly more than  fifty percent (50%) of the then outstanding common shares or voting power of the entity resulting  from such business combination; or (c) the sale of all or substantially all of such Party’s assets or  business relating to the subject matter of the Agreement.  1.17 Change of Control Group  The term “Change of Control Group” shall mean with respect to a Party, the person or entity, or  group of persons or entities, that is the acquirer of, or a successor to, a Party in connection with  a Change of Control, together with affiliates of such persons or entities that are not Affiliates of  such Party immediately prior to the completion of such Change of Control of such Party.    1.18 Clinical Study  The term “Clinical Study” shall mean a Phase I Study, Phase II Study, Phase III Study, as  applicable.    1.19 Collaboration Product  The term “Collaboration Product” shall mean any product or composition containing [***]. A  Collaboration Product shall differentiate itself from another Collaboration Product by addressing  a different Collaboration Target.      1.20 Collaboration Product Valid Claim   The term "Collaboration Product Valid Claim" shall mean, for a given Collaboration Product in a  given country of the Territory, (a) [***]; or (b) [***].    1.21 Collaboration Target  The term “Collaboration Target” shall mean the [***]. As of the Effective Date, the two  Collaboration Targets are [***] (together, the “Initial Targets”, as further described in Appendix  1.18).      1.22 Combination Product  The term “Combination Product” shall mean  a) [***],  b) [***], or  c) [***].     





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 11 -  1.23 Commercially Reasonable Efforts  The term “Commercially Reasonable Efforts” shall mean such level of efforts required to carry out  such obligation in a sustained manner consistent with the efforts Genentech or Pieris, as  applicable, devotes at the same stage of development or commercialization, as applicable, for its  own internally developed pharmaceutical products in a similar area with similar market potential,  at a similar stage of their product life taking into account the existence of other competitive  products in the market place or under development, the proprietary position of the product, the  regulatory structure involved, the anticipated profitability of the product and other relevant factors.  It is understood that such product potential may change from time to time based upon changing  scientific, business and marketing and return on investment considerations.    However, Genentech (and its Affiliates) does not always seek to market its own products in every  country or seek to obtain regulatory approval in every country or for every potential indication. As  a result, the exercise of diligence by Genentech is to be determined by judging Genentech’s  commercially reasonable efforts, taken as a whole.    1.24 Companion Diagnostic   The term “Companion Diagnostic” shall mean [***].    1.25 Competing Product  The term “Competing Product” shall mean, with respect to each Collaboration Product, any [***],  as applicable.    1.26 Compulsory Sublicense  The term “Compulsory Sublicense” shall mean a license or sublicense granted to a Third Party (a  “Compulsory Sublicensee”), through the order, decree or grant of a governmental authority  having competent jurisdiction, authorizing such Third Party to manufacture, use, sell, offer for sale,  import or export a Collaboration Product in any country in the Territory.    1.27 Confidential Information  The term “Confidential Information” shall mean any and all information, data or know-how  (including Know-How), whether technical or non-technical, oral or written, that is disclosed by one  Party or its Affiliates (“Disclosing Party”) to the other Party or its Affiliates (“Receiving Party”).  Confidential Information shall not include any information, data or know-how that:  (i) was generally available to the public at the time of disclosure, or information that  becomes available to the public after disclosure by the Disclosing Party other than  through fault (whether by action or inaction) of the Receiving Party or its Affiliates,  (ii) can be evidenced by written records to have been already known to the Receiving Party  or its Affiliates prior to its receipt from the Disclosing Party,  (iii) is obtained at any time lawfully from a Third Party under circumstances permitting its use  or disclosure,  (iv) is developed independently by the Receiving Party or its Affiliates as evidenced by written  records other than through knowledge of Confidential Information, or  (v) is approved in writing by the Disclosing Party for release by the Receiving Party.    The terms of this Agreement shall be considered Confidential Information of the Parties.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 12 -    Any information resulting from the Research Plan(s) directly related to Selected Binders (including,  for the avoidance of doubt, Binders that will subsequently become Selected Binders) shall be  considered Genentech’s Confidential Information. Pieris Platform Technology or improvements to  Pieris Platform Technology shall be considered Pieris’ Confidential Information. For avoidance of  doubt, Know-how and information related to (a) Pieris’ experimental methods and assays  conducted by or on behalf of Pieris in connection with the Research Plan(s), including the  discovery and development of the Binders, as well as the Pieris Platform Technology and  improvements to Pieris Platform Technology are and shall remain Pieris’ Confidential Information,  and (b) Genentech’s experimental methods or assays deployed in connection with the Research  Plan(s), whether used by Genentech or Pieris, are and shall remain Genentech’s Confidential  Information.     1.28 Continuation Election Notice  The term “Continuation Election Notice” shall mean the notice Pieris may provide to Genentech  under Section 19.3.4.     1.29 Control  The term “Control” shall mean (as an adjective or as a verb including conjugations and variations  such as “Controls” “Controlled” or “Controlling”) (a) with respect to Patent Rights and/or Know- How, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights  and/or Know-How without violating the terms of any agreement or arrangement between such  Party and any other party and (b) with respect to proprietary materials, the possession by a Party  of the ability to supply such proprietary materials to the other Party as provided herein without  violating the terms of any agreement or arrangement between such Party and any other party.    1.30 Cover  The term “Cover” shall mean (as an adjective or as a verb including conjugations and variations  such as “Covered,” “Coverage” or “Covering”) (a) that the developing, making, using, offering for  sale, promoting, selling, exporting or importing of a given compound, formulation, process or  product would—in the absence of a license—infringe a Patent Right (or, in the case of a Patent  Right that has not yet issued, would infringe any then-pending claim in such Patent Right if it were  to issue with such claim) or (b) with respect to the applicable invention, discovery, process or  product, any Know-How, that, in the absence of a (sub)license under, or ownership of, such Know- How, the development, manufacture or commercialization (including making, using, offering for  sale, selling or importing thereof) of such invention, discovery, process or product incorporates,  embodies or otherwise makes use of such Know-How. The determination of whether a compound,  formulation, process or product is Covered by a particular Valid Claim shall be made on a country- by-country basis.    1.31 Dev Go Decision  The term “Dev Go Decision” shall mean, for a given Collaboration Product, [***].    1.32 Development Event  The term “Development Event” shall mean achievement of a certain development stage by a  given Collaboration Product.   





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 13 -    1.33 Dollars  The term “Dollars” or “$” shall mean the lawful currency of the US.    1.34 Effective Date  The term “Effective Date” shall mean May 19, 2021.     1.35 EU  The term “EU” shall mean the European Union and all its then-current member countries.    1.36 EU4  The term “EU4” shall mean Germany, France, Italy and Spain.    1.37 Expert  The term “Expert” shall mean a person with no less than fifteen (15) years of pharmaceutical  industry experience and expertise having occupied at least one senior position within a large  pharmaceutical company relating to product development and/or licensing but excluding any  current or former employee or current consultant of either Party. Such person shall be fluent in  the English language.    1.38 FDA  The term “FDA” shall mean the Food and Drug Administration of the United States of America.    1.39 FDCA  The term “FDCA” shall mean the Food, Drug and Cosmetics Act.    1.40 Field  The term “Field” shall mean all biopharmaceutical, biomedical and diagnostic uses, including all  therapeutic and prophylactic uses.    1.41 Filing  The term “Filing” shall mean the filing of an application by the FDA as defined in the FDCA and  applicable regulations, or the equivalent application to the equivalent agency in any other country  or group of countries, the official approval of which is required before any lawful commercial sale  or marketing of Collaboration Products.    1.42 First Commercial Sale  The term “First Commercial Sale” shall mean, on a country-by-country basis, the first invoiced  sale of a Collaboration Product to a Third Party by the Roche Group following the receipt of any  Regulatory Approval required for the sale of such Collaboration Product, or if no such Regulatory  Approval is required, the date of the first invoiced sale of a Collaboration Product to a Third Party  by the Roche Group in such country.     





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 14 -  1.43 GLP Tox Study  The term “GLP Tox Study” shall mean a study in accordance with the Good Laboratory Practice  (GLP) to generate data by which the hazards and risks to users, consumers and third parties,  including the environment, can be assessed for a product.    1.44 Governmental Authority  The term “Governmental Authority” shall mean any applicable government authority, court,  tribunal, arbitrator, agency, department, legislative body, commission or other instrumentality of  (a) any government of any country or territory, (b) any nation, state, province, county, city or other  political subdivision thereof or (c) any supranational body.    1.45 Handle  The term “Handle” shall mean preparing, filing, prosecuting (including Third Party observations,  interference and opposition proceedings) and maintaining (including interferences, reissue, re- examination, post-grant reviews, inter-parties reviews, derivation proceedings, invalidation  proceedings, and opposition proceedings).    1.46 HSR  The term “HSR” shall mean the Hart-Scott-Rodino Antitrust Improvements Act.    1.47 ICD  The term “ICD” shall mean the Tenth Revision of the International Classifications of Diseases and  Related Health Problems of 2010.    1.48 IFRS  The term “IFRS” shall mean International Financial Reporting Standards.    1.49 IND  The term “IND” shall mean an application as defined in the FDCA and applicable regulations  promulgated by the FDA, or the equivalent application to the equivalent agency in any other  country or group of countries, the filing of which is necessary to commence clinical testing of the  Collaboration Products in humans.    1.50 Indication   The term “Indication” shall mean a distinct type of disease or medical condition in humans to  which a Collaboration Product is directed and eventually approved. To distinguish one Indication  from another Indication, the two Indications have to be (i) [***] and (ii) [***]. Notwithstanding the  foregoing, [***]. For clarity, (a) [***] and (b) [***].     1.51 Initiation  The term “Initiation” or “Initiated” shall mean, with respect to Clinical Studies, the date that a  human is first dosed with the Collaboration Product in a Clinical Study approved by (or allowed  by) the respective Regulatory Authority, or, with respect to GLP Tox Studies, the date an animal  is first dosed with the Collaboration Product in a GLP Tox Study approved by (or allowed by) the  respective Regulatory Authority.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 15 -  1.52 Insolvency Event  The term “Insolvency Event” shall mean circumstances under which a Party (i) has a receiver or  similar officer appointed over all or a material part of its assets or undertaking; (ii) passes a  resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any  solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes  an order for administration (or any equivalent order in any jurisdiction); (iii) enters into any  composition or arrangement with its creditors (other than relating to a solvent restructuring); (iv)  ceases to carry on business; (v) is unable to pay its debts as they become due in the ordinary  course of business.    1.53 Invention  The term “Invention” shall mean an invention that is conceived or reduced to practice in  connection with any activity carried out pursuant to this Agreement. Under this definition, an  Invention may be made (including conceived) by employees of Pieris solely or jointly with a Third  Party (a “Pieris Invention”), by employees of Genentech solely or jointly with a Third Party (a  “Genentech Invention”), or jointly by employees of Pieris and employees of Genentech with or  without a Third Party (a “Joint Invention”). Inventorship shall be determined in accordance with  US patent laws.    1.54 JRC   The term “JRC” shall mean the joint research committee described in Section 6.    1.55 Know-How  The term “Know-How” shall mean data, knowledge and information, including materials, samples,  chemical manufacturing data, toxicological data, pharmacological data, preclinical data, assays,  platforms, formulations, specifications, quality control testing data, that are necessary or useful  for the discovery, manufacture, development or commercialization of Selected Binders and  Collaboration Products.    1.56 LSR Go Decision  The term “LSR Go Decision” shall mean, for a given Collaboration Target, the [***].    1.57 NDA  The term “NDA” shall mean a new drug application, including all necessary documents, data, and  other information concerning a Collaboration Product, required for Regulatory Approval of the  Collaboration Product as a pharmaceutical product by the FDA or an equivalent application to the  equivalent agency in any other country or group of countries (e.g. the marketing authorization  application (MAA) in the EU).    1.58 Net Sales  The term “Net Sales” shall mean, for a Collaboration Product in a particular period, the amount  calculated by subtracting from the Sales of such Collaboration Product for such period: (i) [***];  (ii) [***]; (iii) [***]; and (iv) government mandated fees and taxes and other government charges  accrued [***]. For clarity, no deductions taken in calculating Sales under Section 1.80 may be  taken a second time in calculating Net Sales.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 16 -  1.59 New IP  The term “New IP” means the (a) Binder IP; and (b) Pieris Platform Improvement IP.      1.60 Non-Selected Binder(s)  The term “Non-Selected Binder(s)” shall mean Binders (i) [***]; (ii) [***]; and (iii) [***].    1.61 Non-Selected-Binder IP  The term “Non-Selected-Binder IP” is defined in Section 14.2.    1.62 Party  The term “Party” shall mean Pieris or Genentech, as the case may be, and “Parties” shall mean  Pieris and Genentech collectively.    1.63 Patent Rights  The term “Patent Rights” shall mean all rights under any patent or patent application, in any  country of the Territory, including any patents issuing on such patent application, and further  including any substitution, extension or supplementary protection certificate, reissue,  reexamination, renewal, division, continuation or continuation-in-part of any of the foregoing.    1.64 Phase I Study  The term “Phase I Study” shall mean a human clinical trial in any country that would satisfy the  requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign  equivalent thereof.     1.65 Phase II Study  The term “Phase II Study” shall mean a human clinical trial, for which the primary endpoints  include a determination of dose ranges and/or a preliminary determination of efficacy in patients  being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and  the foreign equivalent thereof.    1.66 Phase III Study  The term “Phase III Study” shall mean a human clinical trial that is prospectively designed to  demonstrate statistically whether a product is safe and effective for use in humans in a manner  sufficient to obtain regulatory approval to market such product in patients having the disease or  condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to  time, and the foreign equivalent thereof.    1.67 Pieris Background IP  The term “Pieris Background IP” shall mean (a) Know-How (i) Controlled by Pieris as of the  Effective Date, or created and Controlled by Pieris after the Effective Date outside the course of  activities conducted under this Agreement; and (ii) during the Agreement Term that is reasonably  necessary or reasonably useful for the discovery, manufacture, development or  commercialization of any Binder, Selected Binder or Collaboration Product; and (b) any Patent  Rights Controlled by Pieris and claiming the foregoing Know-How in Section 1.66(a) (“Pieris  Background Patent Rights”). The Pieris Background Patent Rights existing as of the Effective  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 17 -  Date are set forth in Appendix 1.66 and shall be updated from time to time upon written request  of Genentech.  Notwithstanding the foregoing, [***].    1.68 Pieris Platform Background IP  The term “Pieris Platform Background IP” means (a) all Know-How within the Pieris Background  IP that are necessary or useful for the practice of the Pieris Technology and (b) those Patent  Rights Controlled by Pieris within the Pieris Background IP claiming the foregoing Know-How in  Section 1.68(a). (“Pieris Platform Background Patent Rights”). The Pieris Platform Background  Patent Rights existing as of the Effective Date are set forth in Appendix 1.68 and shall be updated  from time to time upon written request of Genentech.    1.69 Pieris Platform Improvement IP  The term “Pieris Platform Improvement IP” means (a) [***] and (b) [***] (“Pieris Platform  Improvement Patent Rights”).    1.70 Pieris Technology  The term “Pieris Technology” shall mean Anticalin Libraries, Anticalin Selection, Anticalin  Expression and Anticalin Affinity Maturation methods.    1.71 Qualified Hit  The term “Qualified Hit” shall mean, [***].     1.72 Regulatory Approval  The term “Regulatory Approval” shall mean any approvals, licenses, registrations or  authorizations by Regulatory Authority, necessary for the sale of a Collaboration Product in the  Field in a regulatory jurisdiction in the Territory.     1.73 Regulatory Authority  The term “Regulatory Authority” shall mean any national, supranational (e.g., the European  Commission, the Council of the European Union, the European Medicines Agency), regional,  state or local regulatory agency, department, bureau, commission, council or other governmental  entity including the FDA, in each country involved in the granting of Regulatory Approval for the  Collaboration Product.    1.74 Research Plan  The term “Research Plan” shall mean a plan of research for each Collaboration Target, outlining  the work expected to be performed by Pieris and Genentech including which work will be  commissioned to a Third Party (for clarity, the Party responsible for an activity under a Research  Plan shall bear any cost of such work being commissioned to a Third Party in accordance with  the Research Plan). The Research Plans for the Initial Targets are attached as Appendix 1.78 (A)  and 1.78 (B), as such plans may be updated from time to time as permitted in this Agreement.  The Research Plans for any Replacement Target or Subsequent Target shall be prepared by the  JRC as further described in Section 3.1.5.    1.75 Roche Group  The term “Roche Group” shall mean collectively Genentech, its Affiliates and its Sublicensees.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 18 -    1.76 Royalty Term  The term “Royalty Term” shall mean, with respect to a Collaboration Product and for a given  country, the period of time commencing on the date of First Commercial Sale of such  Collaboration Product in such country and ending on the later of the date that is (a) [***], and (b)  [***].    1.77 Sales  The term “Sales” shall mean, for a Collaboration Product in a particular period, [***]:    (i) [***].    By way of example, the gross-to-net deductions taken in accordance with IFRS as of the  Effective Date include the following:    (a) credits, reserves or allowances granted for (i) damaged, outdated, returned,  rejected, withdrawn or recalled Collaboration Product, (ii) wastage replacement and  short-shipments; (iii) billing errors and (iv) indigent patient and similar programs (e.g.,  price capitation);    (b) governmental price reductions and government mandated rebates;    (c) chargebacks, including those granted to wholesalers, buying groups and retailers;    (d) customer rebates, including cash sales incentives for prompt payment, cash and  volume discounts; and    (e) taxes and any other governmental charges or levies imposed upon or measured by  the import, export, use, manufacture or sale of a Collaboration Product (excluding  income or franchise taxes).    For purposes of clarity, [***].    (ii) for Sublicensees that are not Genentech Affiliates (and excluding Compulsory Sublicensees),  [***]. For the purpose of clarity, any such Sublicensee sales as reported to Genentech in  accordance with Compulsory Sublicense agreements shall be [***].    1.78 Screening Failure  The term “Screening Failure” shall mean a screening campaign that fails to identify at least [***]  as defined in the applicable Research Plan.    1.79 Selected Binder  The term “Selected Binder” shall mean, [***].    1.80 Selected Binder IP  The term “Selected Binder IP” is defined in Section 14.2.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 19 -    1.81 Sublicensee  The term “Sublicensee” shall mean an entity to which Genentech has licensed any right (through  one or multiple tiers), other than through a Compulsory Sublicense, pursuant to this Agreement.    1.82 Substitution Period  The term “Substitution Period” shall mean, on a Collaboration Target-by-Collaboration Target  basis, the period that is [***].    1.83 Target Term  The term “Base Target Term” shall mean, for each of the Initial Targets, a period commencing on  the Effective Date and ending on the earlier of completion of the applicable Research Plan or after  [***]. The Target Term for a given Replacement Target or a Subsequent Target commences on  the date the JRC approves the Research Plan for the applicable Collaboration Target and ends  on the earlier of completion of such Research Plan or after [***]. At the end of the Target Term for  each Collaboration Target, Genentech will have the option, at its sole discretion, to extend the  Target Term by up to [***] to facilitate completion of the Research Plan (“Extended Target Term”).  The term “Target Term” shall include “Base Target Term” and “Extended Target Term” when such  extension is requested.      1.84 Territory  The term “Territory” shall mean all countries of the world.    1.85 Third Party  The term “Third Party” shall mean a person or entity other than (i) Pieris or any of its Affiliates or  (ii) a member of the Roche Group.    1.86 UK  The term “UK” shall mean the United Kingdom.    1.87 US  The term “US” shall mean the United States of America and its territories and possessions.    1.88 Valid Claim   The term “Valid Claim” shall mean, with respect to a particular country, (a) a claim in any unexpired  and issued Patent Rights that has not been disclaimed, revoked or held invalid by a final non- appealable decision of a court of competent jurisdiction or government agency or (b) a claim of  pending Patent Rights that has not been abandoned, finally rejected or expired without the  possibility of appeal or refiling; provided, however, that Valid Claim will exclude any such pending  claim in an application that has not been granted within [***] years following the earliest priority  filing date for such application, excluding, [***].      1.89 Additional Definitions  Each of the following definitions is set forth in the Section of this Agreement indicated below:    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 20 -  Definition Section  Accounting Period 11.1  Acquired Party 19.2.3  Alliance Director 6.8  Anticalin Protein 1.4  Bankruptcy Code 20  Biologic 3.1.8  Breaching Party 19.2.1  Chairperson 6.2  Chugai 1.1  Companion Diagnostic Product 10.4  Compulsory Sublicensee 1.25  Disclosing Party 1.26  Expert Committee 10.7  Extended Target Term 1.84  Genentech Indemnified Parties 16.2  Indemnified Party 16.3  Indemnifying Party 16.3  Joint Invention 1.53  Members 6.2  Non-Acquired Party 19.2.3  Non-Breaching Party 19.2.1  Non-Selected-Binder IP 14.2  Patent Term Extensions 14.12  Payment Currency 11.3  Peremptory Notice Period 19.2.1  Pieris Indemnified Parties 16.1  Pieris Invention 1.53  Progress Reports 3.1.6  Publishing Notice 18.4  Publishing Party 18.4  Receiving Party 1.26  Reference Product Sponsor 14.11  Relative Commercial Value 10.7  Replacement Target 3.1.3  Research Records 3.1.7  Genentech Invention 1.53  Genentech Valid Claim 19.3.4 (b)  Samples 19.3.4 (b)  SEC 1.9  Sales Event 10.4  Selected Binder IP 14.2  [***] 14.9.1  Sensitive Information 19.2.3  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 21 -  Definition Section  Similar Program 3.1.8  SPCs 14.12  Stand-alone Diagnostic Product 10.4  Subsequent Target(s) 3.1.2  Subsequent Target Fee 10.2  Target Substitution Fee 10.3    2. Grant of License    2.1 Research Licenses    Pieris grants to Genentech during the Agreement Term an exclusive (even as to Pieris, except for  activities performed under the Research Plan) right and license, including the right to sublicense  through multiple tiers, under Pieris Background IP and a non-exclusive right and license, including  the right to sublicense through multiple tiers, under Pieris Platform Improvement IP and Non- Selected-Binder IP that are necessary or useful for the discovery, manufacture or development  of Binders, Selected Binders and Collaboration Products, in particular to enable Genentech to  identify and evaluate Binders in order to enable selection of Selected Binders; notwithstanding  the foregoing, such license shall be non-exclusive with respect to the Pieris Platform Background  IP.     2.2 Commercial License to Genentech  Pieris hereby grants to Genentech (a) an exclusive (even as to Pieris) right and license, including  the right to sublicense through multiple tiers, under Pieris’ interest in the Pieris Background IP;  and (b) a non-exclusive right and license, including the right to sublicense through multiple tiers,  to the Pieris Platform Improvement IP and Non-Selected-Binder IP to research, have researched,  develop, have developed, register, have registered, use, have used, make, have made, import,  have imported, export, have exported, market, have marketed, distribute, have distributed, sell  and have sold Collaboration Products in the Field in the Territory; notwithstanding the foregoing,  such license shall be non-exclusive with respect to the Pieris Platform Background IP.    2.3 Sublicense  Genentech shall have the right to sublicense or subcontract (through multiple tiers); provided,  however, that in the event of such sublicensing, (a) such Sublicensees will be subject to the same  confidentiality and diligence obligations Genentech has hereunder, and (b) Genentech will remain  liable for all the terms and conditions of this Agreement.    2.4 License to Pieris after Target Term  Effective upon [***], Genentech hereby grants to Pieris [***].     





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 22 -  3. Research Collaboration  3.1.1 Scope  During the Target Term, Genentech and Pieris will collaborate on the discovery and preclinical  development of molecules against up to [***] Collaboration Targets pursuant to detailed Research  Plans that are mutually agreed between the Parties and that outline research activities,  responsibilities, and criteria for advancement of Binders and Selected Binders.    Pieris will be responsible for research activities following target nomination through LSR Go  Decision, including lead selection, lead optimization and lead candidate(s) characterization. The  Parties will collaborate for drug candidate characterization until the Dev Go Decision. Genentech  will advise Pieris throughout the collaboration on the development of the Selected Binder(s) for  LSR Go Decision.   3.1.2 Subsequent Target rights and reserved targets  Genentech shall have the right to nominate [***] additional Collaboration Targets (“Subsequent  Target(s)”) as set forth in Section 3.1.3. For a period of [***] years following the Effective Date,  [***]. All other potential Replacement or Subsequent Targets are subject to Availability. Each  potential Collaboration Target nominated by Genentech as set forth in Section 3.1.3 shall be  believed by Genentech, at its reasonable discretion, based on scientific research or literature to  play a role for the prevention, mitigation or treatment of respiratory or ophthalmic diseases.  3.1.3 Nomination of Subsequent Targets and Replacement Targets; Audit Right  a) Nomination of Subsequent Targets. As early as [***], but no later than [***] following the  Effective Date, Genentech may nominate at any time (simultaneously or at different times)  up to [***] potential Subsequent Targets through written request to Pieris. Pieris shall notify  Genentech about the Availability of such nominated Target within [***] days of receipt of  such written request. If such nominated Target is Available, it shall become designated as  a Subsequent Target at the time of such notification by Pieris, and Genentech shall owe  Pieris the Subsequent Target Fee as set forth in Section 10.2. If such nominated Target  is not Available, then Genentech may nominate a different potential Subsequent Target  within the timeframe set forth in the first sentence of this Section 3.1.3.     b) Nomination of Replacement Targets. Additionally, at any time during the Substitution  Period and subject to Availability, Genentech may substitute each Collaboration Target  (other than, for the avoidance of doubt, any Replacement Target) with a different  Collaboration Target (a “Replacement Target”) up to [***] (i) at [***] cost in case of a  Screening Failure, or (ii) [***] set forth in Section 10.3 in all other cases. Pieris shall notify  Genentech about the Availability of such nominated Target within [***] days of receipt of  such written request. If such nominated Target is Available, it shall become designated as  a Replacement Target at the time of such notification by Pieris. If such nominated Target  is not Available, then Genentech may nominate a different potential Replacement Target  within the Substitution Period.     





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 23 -  c) Audit Right. If a Subsequent Target and/or a Replacement Target is not accepted by Pieris  to be Available, Genentech may, by providing Pieris with written notice within [***] days of  receipt of such rejection notice, employ an independent, internationally recognized law  firm and/or public accounting firm acceptable to Pieris (the “Auditor”) to review Pieris’s  applicable records that demonstrate that the Subsequent Target and/or a Replacement  Target (as applicable) was not Available.  Within [***] days after the appointment of the  Auditor, Pieris will provide to the Auditor a complete and accurate copy of its relevant  records demonstrating that the applicable Subsequent Target and/or a Replacement  Target was not Available. Depending on Pieris’s rationale for applicable Subsequent  Target and/or a Replacement Target was not Available, the relevant records that Pieris  would provide to the Auditor could consist of a copy of the applicable license agreement(s)  that evidence that Pieris was under the applicable obligations to a Third Party (subject to  redaction by Pieris with respect to financial terms and other information that is  unnecessary for the Auditor to make its determination), a copy of notebooks or other  documentation demonstrating Pieris’s internal efforts on such Subsequent Target and/or  a Replacement Target (as applicable).    Prior to performing an audit hereunder, the Auditor shall promptly enter into a written  confidentiality agreement with Pieris, consistent with this Section and Article 18. The  Auditor will provide its audit report to both Parties, and if it concludes that the rejected  Subsequent Target and/or a Replacement Target (as applicable) was Available, such  originally rejected Subsequent Target and/or a Replacement Target (as applicable) shall  automatically be accepted as a Subsequent Target and/or a Replacement Target (as  applicable), and [***]. If, on the other hand, the audit report concludes that the rejected  Subsequent Target and/or a Replacement Target (as applicable) was not Available, [***]  and may nominate a further Subsequent Target and/or a Replacement Target (as  applicable) as per the applicable Sections. All such records reviewed by the Auditor shall  be used only for the purpose of confirming whether or not a rejected Subsequent Target  and/or a Replacement Target (as applicable) is Available and shall be treated as Pieris’s  Confidential Information subject to the obligations of this Agreement. The Auditor shall  state only factual findings in the audit report, shall not interpret this Agreement, shall not  reveal any Pieris Confidential Information to Genentech and shall not disclose the Pieris- provided documents.  3.1.4 Diligent Efforts  For each Collaboration Target, Genentech and Pieris shall each use Commercially Reasonable  Efforts to perform, and complete within the Target Term or Extended Target Term, as applicable,  their respective tasks and obligations in conducting all activities ascribed to it in the then-current  Research Plan for such Collaboration Target, in accordance with the time parameters set forth  therein. If the objectives in the applicable Research Plan have not been completed by the end of  the Extended Target Term, the Parties shall strive to agree on whether to further extend the  applicable Target Term and the share of funding by each party.  3.1.5 Research Plans  The Parties will conduct the research for a given Collaboration Target in accordance with the  applicable Research Plan. Each Party will bear its cost to carry out its obligations under each  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 24 -  Research Plan. The Research Plans for the Initial Targets are attached as Appendix 1.78 (A) and  1.78 (B). Research Plans for each Subsequent or Replacement Target, as applicable, shall be  prepared by the JRC as soon as possible, but no later than within [***] days after Pieris confirms  Availability of such Subsequent Target or Replacement Target and Pieris shall initiate activities  included in such Research Plan as soon as possible, but no later than within [***] days after such  Research Plan has been prepared. Notwithstanding the foregoing, should [***] Targets become  designated as Subsequent Target(s) or replacement Target(s) within a period of less than [***]  months, then Pieris shall have [***] days to initiate activities included in the applicable Research  Plan for the second such designated Subsequent or Replacement Target. In alignment with  Section 6.3, each Research Plan will be updated as needed by the JRC, with such updates to be  documented in an updated Research Plan as part of the applicable JRC Minutes. Each Research  Plan will set forth (i) the scope of the research and the resources that will be dedicated to the  activities contemplated within the scope of the research, including the responsibilities of each  Party, and (ii) specific objectives for each Research Plan task, which objectives will be updated  or amended, as appropriate, by the JRC as research progresses.     3.1.6 Progress Reports and Information Exchange  At least [***] during the Target Term for a given Collaboration Target, Pieris shall have the  obligation to prepare and provide to the JRC a detailed written report summarizing the progress  of the work performed by Pieris under the applicable Research Plan during the preceding  Calendar Quarter. Genentech will provide updates about its activities under such Research Plan  through the JRC meetings. On a Collaboration Target-by-Collaboration Target basis, promptly  upon expiry of the Target Term, Pieris shall provide a final written report summarizing its activities  under the applicable Research Plan and the results thereof. Upon the written request of  Genentech and not more than [***], Pieris shall permit Genentech, [***], to have access during  normal business hours to those records of Pieris that may be necessary to verify the basis for any  payments hereunder.    3.1.7 Research Records  Each Party shall maintain records regarding the execution of the Research Plan(s) (or cause such  records to be maintained) in sufficient detail and in good scientific manner as will properly reflect  all work done and results achieved by or on behalf of such Party in the performance of the  Research Plan(s).    3.1.8 Work on Target by Pieris  After expiry of the applicable Target Term, Pieris shall be permitted to research, develop, or  commercialize alone, or with a Third Party, Binders against such Collaboration Target that are  [***]. Further, and subject to [***], Pieris shall be permitted, at any time after expiry of the applicable  Target Term, [***].    In addition, [***], Pieris shall be permitted to [***]. Further, [***], Pieris shall be permitted, [***].    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 25 -  In case Pieris undergoes a Change of Control and the Change of Control Group has or puts in  place a research program with a Biologic (the term “Biologic” meaning a [***]) targeting a given  Collaboration Target through the same route of administration as the corresponding Collaboration  Product and that does not activate the same Collaboration Target (namely through inhaled or  intraocular delivery, as applicable, such research program being defined as a “Similar Program”),  or if Pieris takes over control of a Third Party having such a Similar Program, then Pieris shall put  or have put in place appropriate fire walls in order to avoid any spillover of information regarding  the Research Plan and associated Progress Reports, Research Records and Confidential  Information received from Genentech under this Agreement outside of the organisation of Pieris  that exists before such Change of Control or take over takes place. Pieris may not perform work  on Pieris Technology with regard to a Collaboration Target except as provided for under this  Agreement.    4. Diligence and limited Non-Compete  4.1 In General  Genentech and Pieris shall use Commercially Reasonable Efforts to perform their respective  activities contemplated by this Agreement or as may be agreed upon in any subsequent written  agreements with respect to the subject matter hereof, including but not limited to any activities  under a Research Plan. Specifically, Genentech agrees to use Commercially Reasonable Efforts  to pursue development and commercialization of [***] Collaboration Product per Collaboration  Target in the Field in the Territory, which minimally shall require that Genentech shall seek to  market [***] Collaboration Product per Collaboration Target in [***]. Notwithstanding anything to  the contrary in this Agreement, [***].      4.2 Diligence of Genentech in Case of Similar Program   If Genentech or any of its Affiliates (i) [***], or (ii) [***], then, [***]. The diligence obligation under  this Section 4.2 expires when [***].     4.3 Limited non-compete  With respect to each Collaboration Target and until the earlier of (i) [***] or (ii) termination of the  corresponding Collaboration Product, each Party covenants that it and its Affiliates will not  research, develop, manufacture or commercialize, itself or with a Third Party, any Competing  Product in the Field.    4.4 Limits  For clarity, the foregoing limitations and obligations associated with acquiring or internally  developing products targeting a given Collaboration Target as described in Section 4.2 shall not  apply to [***].  5. Development  5.1 Development by Genentech  After a Selected Binder against a given Collaboration Target has been transferred from Pieris to  Genentech as specified in the applicable Research Plan, Genentech, [***], shall be responsible  for pursuing pre-clinical and clinical development of Collaboration Product(s) against such  Collaboration Target, subject to the terms of this Agreement.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 26 -    5.2 Provision of Information  Pieris shall disclose and make available to Genentech (i) all data and information developed under  the Research Plan, and (ii) all additional data and information that Pieris reasonably believes are  necessary to conduct development of Collaboration Products. Pieris, through the JRC, shall  answer any questions reasonably posed and provide any information reasonably requested.  Notwithstanding the foregoing, Pieris shall not be obligated to disclose any confidential  information received from a Third Party to Genentech.    6. Governance  6.1 Joint Research Committee  Within [***] days after the Effective Date of this Agreement, the Parties shall establish a JRC to  oversee the research and development activities under this Agreement.    6.2 Members  The JRC shall be composed of [***] persons (“Members”). Genentech and Pieris each shall be  entitled to appoint [***] Members with appropriate seniority and functional expertise. Each Party  may replace any of its Members and appoint a person to fill the vacancy arising from each such  replacement. A Party that replaces a Member shall notify the other Party at least[***] days prior  to the next scheduled meeting of the JRC. Both Parties shall use reasonable efforts to keep an  appropriate level of continuity in representation. Both Parties may invite a reasonable number of  additional experts and/or advisors to attend part or the whole JRC meeting with prior notification  to the JRC. Members may be represented at any meeting by another person designated by the  absent Member. The JRC shall be chaired by [***] (“Chairperson”).     6.3 Responsibilities of the JRC  The JRC shall have the responsibility and authority to:   a) approve the Research Plan for any Collaboration Target other than the Initial Targets;  b) review and approve revisions to the Research Plans;  c) oversee the execution of the Research Plans;  d) establish timelines and criteria for decision points;  e) determine whether a recommendation should be made to the relevant Genentech  governance body whether the success- and other criteria have been met;  f) evaluate Binders and select Selected Binders  g) review the efforts of the Parties and allocate those resources for the Research Plans  (including the budget);  h) identify and agree on the appropriate resources necessary to conduct the Research Plans;  i) establish a touch point site or similar tool to enable secured exchange of data generated  under the Research Plans;  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 27 -  j) monitor and implement the transfer of the Selected Binders, both in terms of material  available at Pieris and the corresponding[***], and any associated data generated under  the Research Plan to Genentech;  k) recommend action items to its respective decision-making bodies;  l) in a JRC meeting towards the end of the applicable Target Term, list the materials and  information to be provided by Pieris to Genentech according to the applicable Research  Plan;   m) attempt to resolve any technical disputes on an informal basis;  n) determine the mechanism of project information exchange, including project team meetings.    The JRC shall have no responsibility and authority other than that expressly set forth in this  section or otherwise expressly provided in this Agreement.    6.4 Meetings  The Chairperson or his/her delegate is responsible for sending invitations and agendas for all  JRC meetings to all Members at least [***] days before the next scheduled meeting of the JRC.  The venue for the meetings shall be agreed by the JRC. The JRC shall hold meetings at least  [***] per calendar year, either in person or by tele-/video-conference (but at least [***] per year in  person), and in any case as frequently as the Members of the JRC may agree shall be necessary,  but not more than [***] times a year. The Alliance Director of each Party may attend the JRC  meetings as a permanent participant and may be a JRC Member.    6.5 Minutes  The Chairperson is responsible for designating a Member to record in reasonable detail and  circulate draft minutes of JRC meetings to all members of the JRC for comment and review within  [***] days after the relevant meeting. The Members of the JRC shall have [***] days to provide  comments. The Party preparing the minutes shall incorporate timely received comments and  distribute finalized minutes to all Members of the JRC within [***] days of the relevant meeting.  The Chairperson approves the final version of the minutes before its distribution.    6.6 Decisions  6.6.1 Decision Making Authority  The JRC shall decide matters within its responsibilities set forth in Section 6.3.  6.6.2 Consensus; Good Faith  The Members of the JRC shall act in good faith to cooperate with one another and seek agreement  with respect to issues to be decided by the JRC. The Parties shall endeavor to make decisions  by consensus.  6.6.3 Failure to Reach Consensus  If the JRC is unable to decide a matter by consensus, then (i) [***], and (ii) [***].    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 28 -  6.7 Information Exchange  Pieris and Genentech shall exchange the information in relation to their activities under the  applicable Research Plan through the JRC and Pieris and Genentech may ask reasonable  questions in relation to the above information and offer advice in relation thereto. The JRC may  determine other routes of information exchange.    6.8 Alliance Director  Each Party shall appoint one person to be the point of contact within each Party with responsibility  for facilitating communication and collaboration between the Parties (each, an “Alliance  Director”). The Alliance Directors may participate in the JRC meetings. The Alliance Directors  shall facilitate resolution of potential and pending issues and potential disputes to enable the JRC  to reach consensus and avert escalation of such issues or potential disputes.    6.9 Limitations of Authority  The JRC shall have no authority to amend or waive any terms of this Agreement.    6.10 Expenses  Each Party shall be responsible for [***] incurred in connection with the JRC.    6.11 Lifetime and Genentech Reporting Obligations  The JRC shall exist until the end of the last Target Term. After the end of the Target Term for any  given Collaboration Target, Genentech shall provide Pieris annual reports describing in  reasonable detail the development progress of the corresponding Collaboration Product(s),  including if a potential milestone is expected within the next [***] months. At Pieris’ request,  Genentech will participate in a telephone conference to answer Pieris’ questions regarding such  annual report. Such annual progress reports shall be provided to Pieris within [***] days after the  end of each Calendar Year.     7. Supply  7.1 Supply of Collaboration Product(s) after Target Term  On a Collaboration Target-by-Collaboration Target basis, following the technology transfer (as  needed) at the end of the applicable Target Term, [***] for the manufacture and supply of the  corresponding Collaboration Product(s).     7.2 Commercial Supply of Collaboration Product(s)  [***] for the commercial manufacture and commercial supply of Collaboration Product(s) for sale  in the Territory, either by itself or through Third Parties.    7.3 Provision of Information  Pieris shall disclose and make available to Genentech all additional data and information that  Pieris reasonably believes are necessary or useful to manufacture and supply the Collaboration  Product(s).    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 29 -  8. Regulatory  8.1 Responsibility  Genentech, [***], shall pursue all regulatory affairs related to Collaboration Product(s) in the  Territory including the preparation and filing of applications for regulatory approval, as well as any  or all governmental approvals required to develop, have developed, make, have made, use, have  used, manufacture, have manufactured, import, have imported, sell and have sold Collaboration  Products. Genentech shall be responsible for pursuing, compiling and submitting all regulatory  filing documentation, and for interacting with regulatory agencies, for all Collaboration Products  in all countries in the Territory. Genentech or its Affiliates shall own and file in their discretion all  regulatory filings and regulatory approvals for all Collaboration Products in all countries of the  Territory.     Genentech, [***], shall report to appropriate authorities in accordance with local requirements all  adverse events related to use of the Collaboration Products in the Territory.    8.2 Information Exchange  With respect to any Anticalin Protein being developed by Pieris for (i) inhaled application for the  prevention, mitigation or treatment of respiratory diseases, or (ii) for intraocular application for the  prevention, mitigation or treatment of ophthalmic diseases, within [***] days after receipt of any  Regulatory Authority communications related to a clinical study hold for safety reasons or for a  potential withdrawal from the market for a safety issue or a report of a serious safety finding by a  Regulatory Authority for such Anticalin Protein, Pieris will provide Genentech, subject to any  confidentiality obligations to Third Parties, with a brief written description of the principal issues  raised in such Regulatory Authority communication.     With respect to each Collaboration Product, within [***] days after receipt of any Regulatory  Authority communications related to a clinical study hold for safety reasons or for a potential  withdrawal from the market for a safety issue or a report of a serious safety finding by a Regulatory  Authority, Genentech will provide Pieris, subject to any confidentiality obligations to Third Parties,   with a brief written description of the principal issues raised in such Regulatory Authority  communication.    The Parties will reasonably cooperate in case a Party reasonably believes that a regulatory filing  by a Party could affect the other Party’s programs, including any Collaboration Product, and in  the case of Pieris, Pieris Technology, including for example for safety reporting requirements.     9. Commercialization  9.1 Responsibility  Genentech, [***], shall have [***] responsibility and decision making authority for the marketing,  promotion, sale and distribution of Collaboration Products in the Territory in accordance with  Applicable Law.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 30 -  10. Payment  10.1 Upfront Fee  Within [***] after the Effective Date and receipt of an invoice from Pieris, Genentech shall pay to  Pieris twenty million Dollars ($ 20,000,000).     10.2 Subsequent Target Fee  Genentech shall pay Pieris a fee of [***] for each Subsequent Target (the “Subsequent Target  Fee”), payable within [***] after the JRC approves the Research Plan for such Subsequent  Target as set forth in Section 3.1.5 and of receipt of an invoice from Pieris.     10.3  Target Substitution Fee  Genentech shall pay Pieris a fee of [***] Dollars ($ [***]) for each Replacement Target (the  “Replacement Target Fee”) if applicable as set forth in Section 3.1.3 (ii), payable within [***] days  after the JRC approves the Research Plan for such Replacement Target and receipt of an invoice  from Pieris.     10.4 Development Event Payments  On a Collaboration Target-by-Collaboration Target basis, for the first Collaboration Product that  reaches the respective Development Event, Genentech shall pay to Pieris the following [***]  payments at the following respective amounts (as listed in the table below):     Development Event (numbers in Dollars) [***] [***]  (a) Qualified Hit $[***] [***]  (b) LSR Go Decision*  $[***] [***]  (c) Dev Go Decision $[***] [***]  (d) Initiation of Phase I Study $[***] [***]  (e) Initiation of Phase II Study $[***] $[***]  (f) Initiation of Phase III Study $[***] $[***]  (g) [***] Filing in [***] $[***] [***]  (h) [***] Filing in [***] $[***] [***]  (i) [***] Filing in [***] $[***] [***]  (j) Regulatory Approval in [***] [***] $[***]  (k) Regulatory Approval in [***] [***] $[***]  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 31 -  (l) Regulatory Approval in [***] [***] $[***]  (m) First Commercial Sale in [***] $[***]   (n) First Commercial Sale in [***] $[***]   (o) First Commercial Sale in [***] $[***]     * In case [***] is not reached until the [***] is reached, the [***] milestone payment will be paid  concurrently with the [***] milestone payment.    For clarity, the maximum amount of Development Event based payments payable under this  Agreement will be [***] US dollars ($[***]) per Collaboration Target.    Upon reaching Development Events, Genentech shall timely notify Pieris and Development Event  payments shall be paid by Genentech to Pieris within [***] days from occurrence of the applicable  event and receipt of a correct invoice from Pieris.     If any of the above Development Events are skipped (i.e., a later Development Event payment is  payable before an earlier Development Event payment), then the skipped Development Event will  be deemed to have been achieved upon the achievement of the subsequent Development Event  and the corresponding Development Event payment(s) shall then become due, as applicable.    10.5 Sales Based Events  On a Collaboration Target-by-Collaboration Target basis, for the first Collaboration Product that  reaches the respective sales event, Genentech shall pay to Pieris the following [***] payments at  the following respective amounts (as listed in the table below):     Sales Event (numbers in Dollars) Amount  (p) First Calendar Year in which [***] Net Sales of a  Collaboration Product exceed [***] US dollars ($[***]) $[***]  (q) First Calendar Year in which [***] Net Sales of a  Collaboration Product exceed [***] US dollars ($[***]) $[***]  (r) First Calendar Year in which [***] Net Sales of a  Collaboration Product exceed [***] US dollars ($[***])  $[***]    For clarity, the maximum amount of sales event based payments payable under this Agreement  will be [***] US dollars ($[***]) per Collaboration Target.    Each of the sales based event payments shall be paid no more than [***] during the Agreement  Term per Collaboration Target, at [***] of the event for the Collaboration Product in the Territory  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 32 -  [***] reaching the respective Net Sales threshold, irrespective of whether or not the previous sales  based event payment was triggered by the same or by a different Collaboration Product (to the  extent such different Collaboration Product is directed to the same Collaboration Target), and  shall be non-refundable, and shall be paid within [***] days after the end of the Calendar Year in  which the event first occurs.    Notwithstanding anything contained in Section 10.4 and 10.5, [***].      10.6 Royalty Payments  10.6.1 Royalty Term  Royalties shall be payable by Genentech on Net Sales of Collaboration Products on a  Collaboration Product-by-Collaboration Product and country-by-country basis until the expiry of  the Royalty Term. Thereafter, the licenses granted to Genentech shall be fully paid up, irrevocable,  and royalty-free.  10.6.2 Royalty Rates  Genentech shall, on a Collaboration Product-by-Collaboration Product basis, pay to Pieris  royalties by applying the following royalty rates to the respective tiers of Calendar Year Net Sales  of a given Collaboration Product in the Territory on an incremental basis, as follows:    Tier of Calendar Year  Net Sales in Dollars of a Collaboration Product:  Percent (%) of  Net Sales:  Up to $[***] Net Sales [***]  More than $[***] Net Sales and up to $[***] Net Sales  [***]  More than $[***] Net Sales and up to $[***] Net Sales [***]  More than $[***] Net Sales [***]    E.g., if in a Calendar Year Net Sales are $[***], then Genentech would pay $[***].    10.6.3 Royalty Reductions  For the purpose of calculating royalties of a Collaboration Product, Calendar Year Net Sales and  the royalty rates shall be subject to the following adjustments, as applicable:  10.6.3.1 No Valid Claim  If no Collaboration Product Valid Claim exists in a given country, or if such claim that previously  existed loses its validity during the applicable Calendar Year, then the royalty payments due to  Pieris for such Collaboration Product in such country shall be [***].    10.6.3.2 Biosimilar Product  Upon the first entry in a given country of a Biosimilar Product, the royalties in such country for the  corresponding Collaboration Product shall be [***] as follows:  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 33 -  a) [***].   b) [***].  10.6.4 Collaboration Products used as Diagnostics  Notwithstanding anything contained in this Section 10.6, [***].     [***].    10.7 Combination Product  If Genentech or its Affiliates intend to sell a Combination Product, then the Parties shall meet  approximately [***] prior to the anticipated First Commercial Sale of such Combination Product in  the Territory to negotiate in good faith and agree to an appropriate adjustment to Net Sales to  reflect the relative commercial value contributed by the components of the Combination Product  (the “Relative Commercial Value”). If, after such good faith negotiations not to exceed [***] days,  the Parties cannot agree to an appropriate adjustment, the dispute shall be initially referred to the  Alliance Directors of the Parties in accordance with Section 21.2. Should the Parties fail to agree  within [***] days of such referral, then the Relative Commercial Value shall be determined by an  Expert Committee under the procedures of this Section.    If the Parties are unable to agree on the Relative Commercial Value, then Genentech will select  [***] who would qualify as an Expert, Pieris will select [***] who would qualify as an Expert, and  those [***] shall select [***] who would qualify as an Expert and who shall be chairman of a  committee of the [***] (the “Expert Committee”), each with a single deciding vote. The Expert  Committee will promptly hold a meeting to review the issue under review, at which it will consider  memoranda submitted by each Party at least [***] days before the meeting, as well as reasonable  presentations that each Party may present at the meeting. The determination of the Expert  Committee as to the issue under review will be binding on both Parties. The Parties will [***] of  the Expert Committee. Unless otherwise agreed to by the Parties, the Expert Committee may not  decide on issues outside the scope mandated under terms of this Agreement.    Notwithstanding the foregoing, for any Combination Product that includes a Companion  Diagnostic Product (i.e., not a Companion Diagnostic), the Relative Commercial Value of such  Companion Diagnostic Product shall [***].    10.8 Third Party Payments  With the exception of [***] and [***], [***] owed to any Third Party in relation to Third Party  intellectual property rights. [***]    10.9 Disclosure of Payments  Each Party acknowledges that the other Party may be obligated to disclose this financial  arrangement, including all fees, payments and transfers of value, as may be advisable or required  under Applicable Law, including the US Sunshine Act.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 34 -  11. Accounting and reporting  11.1 Timing of Payments  Genentech shall calculate royalty payments set forth in Section 10.6 [***] as of [***] (each being  the last day of a reporting period). Genentech shall pay such payments [***] within [***] days after  the end of each reporting period in which Net Sales occur.    11.2 Late Payment  Any payment under this Agreement that is not paid on or before the date such payment is due  shall bear interest, to the extent permitted by Applicable Law, at [***] percentage points above the  average one-month Secured Overnight Financing Rate (SOFR), as reported by Reuters from time  to time, calculated on the number of days such payment is overdue.    11.3 Method of Payment  Royalties on Net Sales and all other amounts payable by Genentech hereunder shall be paid by  Genentech in Dollars (the “Payment Currency”) to account(s) designated by Pieris.    11.4 Currency Conversion  When calculating the Sales of any royalty-bearing Collaboration Product that occur in currencies  other than the Payment Currency, Genentech shall convert the amount of such sales into the  Payment Currency using Genentech’s then-current internal foreign currency translation actually  used on a consistent basis in preparing its audited financial statements (at the Effective Date,  YTD average rate as reported by Reuters).    11.5 Royalties and Sales Reporting  With each payment as set forth in Section 11.1 above, Genentech shall provide Pieris in writing  for the relevant [***] on a Collaboration Product-by-Collaboration Product and region-by-region  (i.e. US, EU, Japan and rest of world) basis the following information: [***].    12. Taxes  Pieris shall pay all sales, turnover, income, revenue, value added, and other taxes levied on  account of any payments accruing or made to Pieris under this Agreement. Genentech agrees to  reasonably assist Pieris in claiming exemption from such taxes and in minimizing the amount  required to be so paid.    If provision is made in law or regulation of any country for withholding of taxes of any type, levies  or other charges with respect to any royalty or other amounts payable under this Agreement to  Pieris, then Genentech shall promptly pay such tax, levy or charge for and on behalf of Pieris to  the proper governmental authority, and shall promptly furnish Pieris with receipt of payment.  Genentech shall be entitled to deduct any such tax, levy or charge actually paid from royalty or  other payment due to Pieris or be promptly reimbursed by Pieris if no further payments are due  to Pieris. Each Party agrees to reasonably assist the other Party in claiming exemption from such  deductions or withholdings under double taxation or similar agreement or treaty from time to time  in force and in minimizing the amount required to be so withheld or deducted.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 35 -  13. Auditing  13.1 Pieris’ Right to Audit  Genentech shall keep, and shall require its Affiliates and Sublicensees to keep, full, true and  accurate books of account containing all particulars that may be necessary for the purpose of  calculating all royalties payable under this Agreement. Such books of accounts shall be kept at  their principal place of business. At the expense of Pieris, Pieris shall have the right to engage an  independent public accountant reasonably acceptable to Genentech to perform, on behalf of  Pieris an audit of such books and records of Genentech and its Affiliates, its licensees and  Sublicensees, that are deemed necessary by Genentech's independent public accountant to  report on Net Sales of Collaboration Product for the period or periods requested by Pieris, and  the correctness of any financial report or payments made under this Agreement.    Upon timely request and at least [***] days' prior written notice from Pieris, such audit shall be  conducted in the countries specifically requested by such independent public accountant, during  regular business hours in such a manner as to not unnecessarily interfere with Genentech's  normal business activities, and shall be limited to results in the [***] Years prior to audit notification.    Such audit shall not be performed more frequently than [***] nor more frequently than once with  respect to records covering any specific period of time.    All information, data documents and abstracts herein referred to shall be used only for the purpose  of verifying royalty statements, shall be treated as Genentech’s Confidential Information subject  to the obligations of this Agreement and need neither be retained more than [***] after completion  of an audit hereof, if an audit has been requested; nor more than[***] from the end of the Calendar  Year to which each shall pertain; nor more than [***] after the date of termination of this Agreement.    13.2 Audit Reports  The auditors shall only state factual findings in the audit reports and shall not interpret the  agreement. The auditors shall share all draft audit reports with both Parties at the same time and  before the final document is issued. The final audit report shall be shared with Genentech at the  same time it is shared with Pieris.    13.3 Over- or Underpayment  If the audit reveals an overpayment, Pieris shall reimburse Genentech for the amount of the  overpayment within [***] days. If the audit reveals an underpayment, Genentech shall make up  such underpayment with the next royalty payment or, if no further royalty payments are owed by  Genentech, Genentech shall reimburse Pieris for the amount of the underpayment within [***]  days. Genentech shall pay for the audit costs if the underpayment of Genentech exceeds [***] of  the aggregate amount of royalty payments owed with regard to the royalty statements subject to  the audit. Section 11.2 shall apply to this Section 13.3.    13.4 Duration of Audit Rights  The failure of Pieris to request verification of any royalty calculation within the period during which  corresponding records must be maintained under this Article 13 will be deemed to be acceptance  of the royalty payments and reports.    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 36 -  14. Intellectual Property  14.1 Ownership of Pieris Background IP   Pieris shall remain the owner of Pieris Background IP (including Pieris Platform Background IP).     14.2 Ownership of New IP  New IP shall consist of Pieris Platform Improvement IP and Binder IP (which consists of Selected  Binder IP and Non-Selected-Binder IP as defined below).       [***]    For each [***], at the end of the applicable Target Term, [***] i) [***]; ii) [***]; and iii) [***] (“Non- Selected-Binder IP”). [***] (“Selected Binder IP”).       The Parties shall reasonably cooperate in the filing and prosecution of Patent Rights for Selected  Binder IP and Non-Selected-Binder IP in order to effectuate the ownership described above,  which may require the filing of divisional patent applications.     Except as specifically set forth herein, this Agreement shall not be construed as (i) giving any of  the Parties any license, right, title, interest in or ownership to the Confidential Information; (ii)  granting any license or right under any intellectual property rights; or (iii) representing any  commitment by either Party to enter into any additional agreement, by implication or otherwise.    14.3 German Statute on Employee’s Inventions  In accordance with the German Statute on Employees’ Inventions, each Party agrees to claim the  unlimited use of any Invention conceived, reduced to practice, developed, made or created in the  performance of, or as a result of, any research program by employees of any German Affiliates  or any other persons acting on behalf of such German Affiliates. For the avoidance of doubt, each  Party is responsible for fulfilling the obligations towards their employees under the German Statute  of Employee’s Inventions.     14.4 Prosecution of Patent Rights within Binder IP prior to the end of the Target Term and  the Non-Selected-Binder IP  The Parties shall align on the time point and content with respect to the [***] that would Cover (i)  Selected Binders or (ii) [***]. Notwithstanding the foregoing, Genentech (a) shall not include any  Pieris’ Confidential Information as defined in Section 1.26 in its filings associated with the Patent  Rights within the Binder IP [***], (b) shall ensure that the claims of all Patent Rights within the  Binder IP [***] are limited to the applicable Collaboration Target, unless Pieris provides prior  written consent (such written consent not to be unreasonably withheld, conditioned or delayed) to  expand such filing beyond the applicable Collaboration Target, and (c) shall not take any action  in the Handling of Patent Rights within the Binder IP [***] that materially impairs the Pieris  Background IP or Pieris Platform Improvement IP.     [***].     14.5 Prosecution of Patent Rights within the Pieris Platform Improvement IP by Pieris  Subject to Section 14.4 above, Pieris shall [***].  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 37 -    14.6 Prosecution of Patent Rights within the Selected Binder IP by Genentech  Subject to Section 14.4 above, Genentech shall[***].    14.7 CREATE Act   This Agreement is a ‘joint research agreement’ as defined in 35 USC 103(c)(3) or Public Law 108- 53 (the “Create Act”). Neither Party may invoke the CREATE Act with respect to any invention  that is developed pursuant to this Agreement without the prior written consent of the other Party.  In the event that either Party intends to overcome a rejection of a claimed invention within the  Binder IP, Selected Binder IP, Non-Selected-Binder IP, Pieris Platform Improvement IP, and/or  Pieris Background IP pursuant to the provisions of the Create Act, such Party shall first obtain the  prior written consent of the other Party and the Parties shall work together in good faith to agree  on how such rejection should be overcome and whether filing of a terminal disclaimer is required;  provided, however, that the Parties shall use Commercially Reasonable Efforts not to impede  each other’s ability to own Patent Rights related to their platform and products (including  Collaboration Products), or not to shorten the patent term of such Patent Rights as a result of  filing any terminal disclaimer.    14.8 Defense  If the manufacture, use, importation, offer for sale or sale of any Collaboration Product pursuant  to this Agreement results in any claim, suit or proceeding alleging patent infringement or trade  secret misappropriation against Pieris or a member of the Roche Group, then such Party shall  promptly notify the other Party hereto in writing. The Parties shall cooperate with each other in  connection with any such claim, suit or proceeding and shall keep each other reasonably informed  of all material developments in connection with any such claim, suit or proceeding.    If a Third Party asserts that Patent Rights owned by or licensed to it are infringed by the  development, manufacture, use, importation, offer for sale or sale of Collaboration Products by a  member of the Roche Group, or that its trade secrets were misappropriated in connection with  such activity, then [***]. Notwithstanding the above, [***].    If an action for infringement is commenced against Pieris, its licensees or its sublicensees related  to Pieris’s conduct of the research program within the scope of the Research Plan or the discovery  of a Collaboration Product, then [***].    14.9 Enforcement  14.9.1 Enforcement of [***] or any other Patent Rights owned or Controlled by Genentech  Genentech shall [***]. If Genentech requests so, [***].    14.9.2 Enforcement of Patent Rights within the Pieris Background IP and the Pieris Platform  Improvement IP  Genentech shall [***].  Notwithstanding the foregoing, [***].  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 38 -    14.10 Common Interest Disclosures  With regard to any information or opinions disclosed pursuant to this Agreement by one Party to  each other regarding intellectual property and/or technology owned by Third Parties, the Parties  agree that they have a common legal interest in determining whether, and to what extent, Third  Party intellectual property rights may affect the conduct of the Research Plan and/or Compounds  and/or Collaboration Products, and have a further common legal interest in defending against any  actual or prospective Third Party claims based on allegations of misuse or infringement of  intellectual property rights relating to the conduct of the Research Plan and/or Compounds and/or  Collaboration Products. Accordingly, the Parties agree that all such information and materials  obtained by Pieris and Genentech from each other will be used solely for purposes of the Parties’  common legal interests with respect to the conduct of the Agreement. All information and  materials will be treated as protected by the attorney-client privilege, the work product privilege,  and any other privilege or immunity that may otherwise be applicable. By sharing any such  information and materials, neither Party intends to waive or limit any privilege or immunity that  may apply to the shared information and materials. Neither Party shall have the authority to waive  any privilege or immunity on behalf of the other Party without such other Party’s prior written  consent, nor shall the waiver of privilege or immunity resulting from the conduct of one Party be  deemed to apply against any other Party.    14.11 Biosimilar or interchangeable biological products  If Genentech requests so, within [***] years after the approval of a Collaboration Product that has  been licensed in the US as a biological product under 42 USC §262(a), and as may be needed  from time to time thereafter, the Parties shall consult as to potential strategies with respect to  unexpired US Patent Rights that Cover the Collaboration Product.  Specifically, in anticipation of  a receipt by the Collaboration Product’s reference product sponsor (“Reference Product  Sponsor”) of a biosimilar or interchangeable product application pursuant to the Biologics Price  Competition and Innovation Act of 2009 (Public Law 111-148), the Parties will discuss the  Reference Product Sponsor’s likely course of action with regard to each such US Patent Right in  the procedural steps set forth under 42 USC §262(l), including a general plan for timely  communication between the Parties in light of the statutory response deadlines.    14.12 Patent Term Extensions  The Parties shall use Commercially Reasonable Efforts to obtain all available patent term  extensions, adjustments or restorations, or supplementary protection certificates (“SPCs”, and  together with patent term extensions, adjustments and restorations, “Patent Term Extensions”).  Pieris shall execute such authorizations and other documents and take such other actions as may  be reasonably requested by Genentech to obtain such Patent Term Extensions, including  designating Genentech as its agent for such purpose as provided in 35 U.S.C. Section 156. All  filings for such Patent Term Extensions shall be made by Genentech (or its Affiliates); provided,  that in the event that Genentech elects not to file for a Patent Term Extension, Genentech shall  (a) promptly inform Pieris of its intention not to file and (b) grant Pieris the right to file for such  Patent Term Extension. Each Party shall execute such authorizations and other documents and  take such other actions as may be reasonably requested by the other Party to obtain such  extensions. The Parties shall cooperate with each other in gaining patent term restorations,  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 39 -  extensions and/or SPCs wherever applicable to such Patent Rights. Notwithstanding the forgoing,  [***].  For clarity, [***].     14.13  Inventorship; Exclusive Dispute Resolution Process  Inventorship shall, to the extent legally permitted, be determined according to the US patent law.   In the event of a dispute between the Parties over inventorship of Binder IP, Selected Binder IP,  Non-Selected-Binder IP, or Pieris Platform Improvement IP, the Parties shall, notwithstanding  anything to the contrary in Article 21.2, refer such dispute to a mutually acceptable independent  outside patent counsel to determine inventorship and shall use all reasonable efforts to do so in  an efficient and expedient manner. The Parties agree that the decision rendered by such  independent outside patent counsel shall be the sole, exclusive and binding resolution and  remedy between them regarding such dispute, and the Parties shall share equally the fees and  expenses of the independent outside patent counsel in resolving such dispute.    15. Representations and Warranties  15.1 Third Party Patent Rights  As of the Effective Date, Pieris has no knowledge of the existence of any patent or patent  application owned by or licensed to any Third Party that could prevent Genentech from making,  having made, using, offering for sale, selling or importing Selected Binders and Collaboration  Products in the Territory.    15.2 Ownership of Patent Rights  Pieris is the exclusive owner of all right, title and interest in, or is the exclusive licensee, with the  right to sublicense in the Field and in the Territory of, the Patent Rights related to Pieris  Background IP.    15.3 Inventors  Pieris warrants that, for Patent Rights owned by Pieris and its Affiliates, the inventors of the  Inventions disclosed and/or claimed in Pieris Background IP have transferred to Pieris full  ownership of the patent rights and know-how licensed under this Agreement.     15.4 Grants  Pieris has the lawful right to grant Genentech and its Affiliates the rights and licenses described  in this Agreement.    15.5 Authorization  The execution, delivery and performance of this Agreement by either Party and all instruments  and documents to be delivered by a Party hereunder: (i) are within the corporate power of such  Party; (ii) have been duly authorized by all necessary or proper corporate action; (iii) are not in  contravention of any provision of the certificate of formation or limited liability company agreement  of such Party; (iv) to the knowledge of such Party, will not violate any law or regulation or any  order or decree of any court of governmental instrumentality; (v) will not violate the terms of any  indenture, mortgage, deed of trust, lease, agreement, or other instrument to which such Party is  a party or by which such Party or any of its property is bound, which violation would have an  adverse effect on the financial condition of such Party or on the ability of such Party to perform its  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 40 -  obligations hereunder; and (vi) do not require any filing or registration with, or the consent or  approval of, any governmental body, agency, authority or any other person, which has not been  made or obtained previously (other than approvals required under the HSR Act, Regulatory  Approvals required for the sale of Collaboration Products and filings with Regulatory Authorities  required in connection with Collaboration Products).    15.6 Validity of Patent Rights  As of the Effective Date, to the best of Pieris’ knowledge, Pieris is not in possession of information  that could render invalid and/or unenforceable any claims that are in any of the Patent Rights  related to Pieris Background IP.  Pieris has no knowledge of any inventorship disputes concerning  any Patent Rights related to Pieris Background IP.    15.7 Control and Validity of Know-How  Each Party represents with respect to its own Know-How that the Know-How of that Party is  Controlled by such Party and has not been misappropriated from any Third Party. The Parties  have taken reasonable measures to protect the confidentiality of its Know-How.    15.8 No Claims  There are no claims or investigations, pending or threatened against Pieris or any of its Affiliates,  at law or in equity, or before or by any governmental authority relating to the matters contemplated  under this Agreement and that would materially adversely affect Pieris’ ability to perform its  obligations hereunder.      15.9 No Conflict  Neither Party nor any of their respective Affiliates is or will be under any obligation to any person,  contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede  the fulfillment of their respective obligations hereunder.    15.10 No Other Representations  EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, THE FOREGOING  REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS  AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION,  WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF  PRODUCTS, VALIDITY AND ENFORCEABILITY OF ANY PATENT RIGHT LICENSED  HEREUNDER, AND NON-INFRINGEMENT OF ANY PRODUCT.    16. Indemnification  16.1 Indemnification by Genentech  Genentech shall indemnify, hold harmless and defend Pieris and its Affiliates, directors, officers,  employees and agents (“Pieris Indemnified Parties”) from and against any and all losses,  expenses, cost of defense (including without limitation attorneys' fees, witness fees, damages,  judgments, fines and amounts paid in settlement) and any amounts Pieris becomes legally  obligated to pay because of any claim or claims against Peiris Indemnified Parties to the extent  that such claim or claims arise out of activities conducted by or on behalf of Genentech under this  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 41 -  Agreement, except to the extent such losses, expenses, costs and amounts are due to the gross  negligence or willful misconduct or failure to act of the Pieris Indemnified Parties.    16.2 Indemnification by Pieris  Pieris shall indemnify, hold harmless and defend Genentech and its Affiliates, directors, officers,  employees and agents (“Genentech Indemnified Parties”) from and against any and all losses,  expenses, cost of defense (including without limitation attorneys' fees, witness fees, damages,  judgments, fines and amounts paid in settlement) and any amounts Genentech becomes legally  obligated to pay because of any claim or claims against Genentech Indemnified Parties to the  extent that such claim or claims arise out of activities conducted by or on behalf of Pieris under  this Agreement, except to the extent such losses, expenses, costs and amounts are due to the  gross negligence or willful misconduct or failure to act of the Genentech Indemnified Parties.    16.3 Procedure  In the event of a claim by a Third Party against a Party entitled to indemnification under this  Agreement ("Indemnified Party"), the Indemnified Party shall promptly notify the other Party  ("Indemnifying Party") in writing of the claim and the Indemnifying Party shall undertake and  solely manage and control, at its sole expense, the defense of the claim and its settlement. The  Indemnified Party shall cooperate with the Indemnifying Party and may, at its option and expense,  be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party  shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without  the Indemnifying Party’s written consent. The Indemnifying Party shall not settle any such claim  unless such settlement fully and unconditionally releases the Indemnified Party from all liability  relating thereto, unless the Indemnified Party otherwise agrees in writing.    17. Liability  17.1 Limitation of Liability  Subject to Article 4, neither Party shall be liable to the other Party as a result of failure or delay to  develop and/or commercialize the Collaboration Product(s), as applicable, including but not  limited to, a) a delay in timelines, or b) delay or failure to recruit patients, or c) a change in its  respective study protocols, or d) failure of the other Party to obtain regulatory approval for the  Collaboration Product(s), as applicable.    17.2 Disclaimer  THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER  REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN. PIERIS  AND GENENTECH DISCLAIM ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED,  WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND  COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION,  WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE  ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL  VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR  PURPOSE WHATSOEVER OF THE PRODUCTS. IN NO EVENT SHALL EITHER PIERIS OR  GENENTECH BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 42 -  DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY  OTHER LEGAL THEORY.    17.3 Insurance  17.3.1 Insurance Coverage  Subject to Section 17.3.3, each Party shall obtain and maintain comprehensive general liability  insurance customary in the industry for companies of similar size conducting similar business,  and in any case sufficient to cover its obligations.  17.3.2 Evidence of Insurance  Within [***] days of the Effective Date, each Party shall provide the other Party with its certificate  of insurance evidencing the insurance coverage set forth Section 17.3.1. Each Party shall  provide to the other Party at least [***] days prior written notice of any cancellation, non-renewal  or material change in any of such insurance coverage.  17.3.3 Election to Self-Insure  In the event that either Party is an entity which, together with its Affiliates, has worldwide revenues  from pharmaceutical sales in excess of [***] Dollars (($[***]) per year, the obligations set forth in  Section 17.3.1 and Section 17.3.2 above shall not apply with respect to such Party, if such Party  notifies the other Party in writing that it elects to provide coverage through a commercially  reasonable program of self-insurance; provided, however, that the obligations set forth in Section  17.3.1 and Section 17.3.2 above shall resume with respect to such Party and its Affiliates, or  successor-in-interest and its Affiliates, if such program of self-insurance is terminated or  discontinued for any reason.  18. Obligation Not to Disclose Confidential Information  18.1 Non-Use and Non-Disclosure  During the Agreement Term and for [***] years thereafter, a Receiving Party shall (i) treat  Confidential Information provided by Disclosing Party as it would treat its own information of a  similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information to  Third Parties, without the Disclosing Party’s prior written consent, and (iii) not use such  Confidential Information other than for fulfilling its obligations under this Agreement.    18.2 Permitted Disclosure  Notwithstanding the obligation of non-use and non-disclosure set forth in Section 18.1, the Parties  recognize the need for certain exceptions to this obligation, specifically set forth below, with  respect to press releases, patent rights, publications, and certain commercial considerations.    18.3 Press Releases  The Parties may issue a press release announcing the existence and selected key terms of this  Agreement, as attached as Appendix 18.3.    Genentech shall issue press releases in accordance with its internal policy that typically does not  issue a second press release until proof of concept has been achieved for a Collaboration Product.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 43 -  Until the end of the applicable Target Term, Genentech shall provide Pieris with a copy of any  draft press release related to the Agreement at least [***] weeks prior to its intended publication  for Pieris' review. Pieris may provide Genentech with suggested modification to the draft press  release. Genentech shall consider Pieris’ timely suggestions in issuing its press release. After the  end of the applicable Target Term, Genentech shall use reasonable efforts to provide Pieris with  a copy of any draft press release related to the applicable Collaboration Product reasonably in  advance of its intended publication.    Pieris shall only issue press release related to the activities contemplated by this Agreement that  (i) have either been approved by Genentech in writing (such approval not to be unreasonably  withheld), or (ii) are required to be issued by Pieris as a matter of law and Pieris has received  competent legal advice to that effect. In all circumstances, Pieris shall provide Genentech with a  draft press release at least [***] weeks prior to its intended publication for Genentech's review.  During such period, Genentech shall (a) approve the draft press release and permit Pieris to issue  the press release, (b) contact Pieris to discuss modification to the draft press release, or (c)  contact Pieris and disapprove the press release. If Genentech asks for modification, then Pieris  shall either make such modification or work with Genentech to arrive at a press release that  Genentech approves. If Pieris issues a press release without Genentech's approval, then Pieris  must obtain competent legal advice that the release was required to be issued by Pieris as a  matter of law.    18.4 Publications  During the Agreement Term, the following restrictions shall apply with respect to disclosure by  any Party of the other Party’s Confidential Information relating to the Collaboration Product in any  publication or presentation:  a) Both Parties acknowledge that it is their policy for the studies and results thereof to be  registered and published in accordance with their internal guidelines. Genentech, in  accordance with its internal policies and procedures, shall have the right to publish all studies,  clinical trials and results thereof on the clinical trial registries that are maintained by or on  behalf of Genentech.   b) A Party ("Publishing Party") shall provide the other Party with a copy of any proposed  publication or presentation at least [***] days prior to submission for publication so as to  provide such other Party with an opportunity to recommend any changes it reasonably  believes are necessary to continue to maintain the Confidential Information disclosed by the  other Party to the Publishing Party in accordance with the requirements of this Agreement.  The incorporation of such recommended changes shall not be unreasonably refused; and if  such other Party notifies ("Publishing Notice") the Publishing Party in writing, within [***]  days after receipt of the copy of the proposed publication or presentation, that such  publication or presentation in its reasonable judgment (i) contains an invention, solely or  jointly conceived and/or reduced to practice by the other Party, for which the other Party  reasonably desires to obtain patent protection or (ii) could be expected to have a material  adverse effect on the commercial value of any Confidential Information disclosed by the other  Party to the Publishing Party, the Publishing Party shall prevent such publication or delay  such publication for a mutually agreeable period of time. In the case of inventions, a delay  shall be for a period reasonably sufficient to permit the timely preparation and filing of a  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 44 -  patent application(s) on such invention, and in no event less than [***] days from the date of  the Publishing Notice.    18.5 Commercial Considerations  (a) Nothing in this Agreement shall prevent Genentech or its Affiliates from disclosing  Confidential Information of Pieris to (i) governmental agencies to the extent required or  desirable to secure government approval for the development, manufacture or sale of  Collaboration Product(s) in the Territory, (ii) Third Parties acting on behalf of Genentech,  to the extent reasonably necessary for the development, manufacture or sale of  Collaboration Product(s) in the Territory, or (iii) Third Parties to the extent reasonably  necessary to market the Collaboration Product in the Territory, provided that for  disclosures according to (ii) or (iii) of this Section, such Third Parties will be subject to the  same confidentiality obligations as Genentech has hereunder.   (b) Nothing in this Agreement shall prevent Pieris or its Affiliates from disclosing (1)  Confidential Information of Genentech to (i) governmental agencies to the extent required  or desirable to secure government approval for the development, manufacture or sale of  Collaboration Product(s) in the Territory as provided for in Section 19.3.4, (ii) Third Parties  acting on behalf of Pieris, to the extent reasonably necessary for (A) Pieris to perform its  activities and obligations under the Research Plan, or (B) the development, manufacture  or sale of Collaboration Product(s) in the Territory as provided for in Section 19.3.4, or (iii)  Third Parties to the extent reasonably necessary to market the Collaboration Product in  the Territory as provided for in Section 19.3.4, or (2) to a Third Party the terms of this  Agreement as part of confidential due diligence carried out by such Third Party in  connection with a potential Change of Control of Pieris; provided that for disclosures  according to (1) (ii) and (iii) or (2) of this Section, such Third Parties will be subject to the  same confidentiality obligations as Pieris has hereunder.   (c) The Receiving Party may disclose Confidential Information of the Disclosing Party to the  extent that such Confidential Information is required to be disclosed by the Receiving Party  to comply with Applicable Law, to defend or prosecute litigation or to comply with  governmental regulations, including without limitation any regulations of the SEC, provided  that the Receiving Party provides prior written notice of such disclosure to the Disclosing  Party and, to the extent practicable, takes reasonable and lawful actions to minimize the  degree of such disclosure.    19. Term and Termination  19.1 Commencement and Term  This Agreement shall commence upon the Effective Date and continue for the Agreement Term.    19.2 Termination  19.2.1 Termination for Breach  A Party (“Non-Breaching Party”) shall have the right to terminate this Agreement in its entirety,  on a country-by-country basis, Collaboration Product-by-Collaboration Product basis in the event  the other Party (“Breaching Party”) is in breach of any of its material obligations under this  Agreement. The Non-Breaching Party shall provide written notice to the Breaching Party, which  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 45 -  notice shall identify the breach and the countries in which the Non-Breaching Party intends to  have this Agreement terminate. The Breaching Party shall have a period of [***] days after such  written notice is provided (“Peremptory Notice Period”) to cure such breach. If the Breaching  Party has a dispute as to whether such breach occurred or has been cured, it will so notify the  Non-Breaching Party, and the expiration of the Peremptory Notice Period shall be tolled until such  dispute is resolved pursuant to Section 21.2. Upon a determination of breach or failure to cure,  the Breaching Party may have the remainder of the Peremptory Notice Period to cure such breach.  If such breach is not cured within the Peremptory Notice Period, then absent withdrawal of the  Non-Breaching Party’s request for termination, this Agreement shall terminate in such countries  effective as of the expiration of the Peremptory Notice Period.    19.2.2 Insolvency  A Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency  Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to  terminate shall only become effective if the Party that incurs the Insolvency Event consents to the  involuntary bankruptcy or such proceeding is not dismissed within [***] days after the filing thereof.    19.2.3 Effects of Change of Control  If there is a Change of Control, then the Party experiencing such Change of Control (“Acquired  Party”) shall provide written notice to the other Party (“Non-Acquired Party”) promptly after  completion of such Change of Control.    The Change of Control Group in connection with such Change of Control shall agree in writing  with the Non-Acquired Party that it will not utilize any of the Non-Acquired Party’s Know-How,  Patent Rights, Inventions, or Confidential Information (collectively, “Sensitive Information”) for  the research, development or commercialization of any product for the treatment of any indication  or patient population for which a Collaboration Product may be developed or commercialized.    Following consummation of the Change of Control, the Non-Acquired Party and the Change of  Control Group shall adopt in writing reasonable procedures to prevent the disclosure of Sensitive  Information beyond the Acquired Party’s personnel who need to know the Sensitive Information  solely for the purpose of fulfilling the Acquired Party’s obligations under this Agreement. The Non- Acquired Party may restrict the Acquired Party’s participation in the JRC and any other committee  in effect at the time of the Change of Control, and decisions of the JRC and other such committees  shall be made by Genentech.    If there is a Change of Control of Pieris involving a company that develops or commercializes  biopharmaceutical products (for clarity, generally for itself and not typically on a contract basis for  other companies), then, upon Genentech’s written request or notice, (i) Pieris will immediately  cease all activity and transfer to Genentech all data developed by Pieris, and (ii) the JRC may be  disbanded at Genentech’s discretion. For clarity, all licenses granted by Pieris to Genentech shall  remain in effect subject to the payment and diligence obligations under this Agreement.     





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 46 -  19.2.4 Voluntary Termination by Genentech  19.2.4.1 Termination Without a Cause  After [***] from the Effective Date, Genentech shall have the right to terminate this Agreement at  any time as a whole, or on a Collaboration Product-by-Collaboration Product and country-by- country basis upon [***] prior written notice before First Commercial Sale of a Collaboration  Product or upon [***] days prior written notice after the First Commercial Sale of a Collaboration  Product.   19.2.4.2 Effective Date of Termination  The effective date of termination under this Section 19.2.4 shall be the date [***] days (or [***]  days as the case may be) after Genentech provides such written notice to Pieris.    19.3 Consequences of Termination  19.3.1 Termination by Pieris for Breach by Genentech or Insolvency of Genentech  Upon any termination by Pieris for breach by Genentech under Section 19.2.1 or Genentech  insolvency under section 19.2.2, the rights and licenses granted by Pieris to Genentech under  this Agreement shall terminate in their entirety or on a country-by-country, Collaboration Target- by-Collaboration Target basis and Collaboration Product-by-Collaboration Product basis, as  applicable, on the effective date of termination, and all licenses granted by Genentech to Pieris  under Section 2.4 shall remain in effect.    19.3.2 Termination by Genentech for Breach by Pieris or Pieris’ Insolvency  Upon any termination by Genentech for breach by Pieris or Pieris’ Insolvency, Genentech and its  Affiliates may upon notice retain all rights and licenses granted to Genentech by Pieris under this  Agreement; provided that after the effective date of termination the amounts of such payments  and royalties that otherwise would have become due and payable shall continue to be due and  payable to Pieris or its successor in interest (as applicable).    19.3.3 Voluntary Termination by Genentech  Upon any voluntary termination by Genentech, the rights and licenses granted by Pieris to  Genentech under this Agreement shall terminate in their entirety or on a country-by-country, and  Collaboration Product-by Collaboration Product basis, as applicable, on the effective date of  termination, and all licenses granted by Genentech to Pieris under Section 2.4 shall remain in  effect.  19.3.4 Termination Prior to Target Term  In case of termination of this Agreement (or a Collaboration Target) for any reason prior to end of  the Target Term for such Collaboration Target, [***].  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 47 -  19.3.5 Continuation Election Notice  In the case of termination by [***] for breach by [***], for [***] or in case of [***], in each case after  the end of [***].   19.3.6 Direct License  Irrespective of anything to the contrary in this Agreement, any existing, permitted sublicense  granted by Genentech under Section 2.3 of this Agreement (and any further sublicenses  thereunder) shall, upon the written request of Genentech, remain in full force and effect, provided  that (i) such Sublicensee is not then in breach of its sublicense agreement (and, in the case of  termination by Pieris for breach by Genentech, that such Sublicensee and any further  sublicensees did not cause the breach that gave rise to the termination by Pieris); and (ii) such  Sublicensee agrees to be bound to Pieris under the terms and conditions of such sublicense  agreement, provided that the payments due to Pieris by such Sublicensee under such sublicense  agreement are no less than the payments that would have been due to Pieris by Genentech under  this Agreement.  19.3.7 Other Activities  19.3.7.1 Ongoing Activities  If Pieris does not provide timely Continuation Election Notice (Section 19.3.4), then Genentech  (a) shall have the right to cancel all ongoing activities and (b) shall complete all non-cancellable  activities at its own expense.     If Pieris provides such timely [***], then [***].    After the effective date of [***], [***].    19.3.7.2 Royalty and Payment Obligations  Termination of this Agreement by a Party, for any reason, shall not release Genentech from any  obligation to pay royalties or make any payments to Pieris that are due and payable prior to the  effective date of termination.     19.4 Survival  Section 11.2 (Late Payment), Article 13 (Auditing), Article 14 (Intellectual Property), Article 16  (Indemnification), Article 18 (Obligation Not to Disclose Confidential Information), Article 19 (Term  and Termination), Section 21.1 (Governing Law), Section 21.2 (Disputes), Section 21.13 (Notice)  and all definitions used in such Articles and Sections shall survive any expiration or termination  of this Agreement for any reason.    20. Bankruptcy  All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement by  Pieris to Genentech are, and shall otherwise be deemed to be, for purposes of Section 365(n) of  Title 11, US Code (the “Bankruptcy Code”) licenses of rights to “intellectual property” as defined  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 48 -  under Section 101(60) of the Bankruptcy Code. Unless Genentech elects to terminate this  Agreement, the Parties agree that Genentech, as a licensee or sublicensee of such rights under  this Agreement, shall retain and may fully exercise all of its rights and elections under the  Bankruptcy Code, subject to the continued performance of its obligations under this Agreement.    21. Miscellaneous  21.1 Governing Law  This Agreement shall be governed by, construed and interpreted in accordance with the laws of  New York, without reference to its conflict of laws principles, and shall not be governed by the  United Nations Convention of International Contracts on the Sale of Goods (the Vienna  Convention).    21.2 Disputes  (a) Unless otherwise set forth in this Agreement, in the event of any dispute in connection  with this Agreement, such dispute shall first be referred to the Alliance Director of each  Party, which shall attempt to resolve such dispute within [***] days of referral, and if a  resolution fails, then such dispute shall be referred to the respective executive officers of  the Parties designated below or their designees, for good faith negotiations attempting to  resolve the dispute. The designated executive officers are as follows:      For Pieris:  CEO   For Genentech: VP, Genentech    (b) Should the Parties fail to agree within [***] days after such dispute has been referred to  the Parties’ designated executive officers, then either Party shall be entitled to request  resolution of the dispute through arbitration, which shall be finally settled under the Rules  of Arbitration of the International Chamber of Commerce by three (3) arbitrators appointed  in accordance with said rules. The place of arbitration shall be New York, US. The  language to be used in the arbitration proceeding shall be English.    21.3 HSR  As Genentech may exercise its right to nominate up to [***] Subsequent Target(s) as set forth in  Section 3.1.3, if needed each Party shall (i) cooperate with the other Party in the preparation,  execution and filing of all documents that that may be required pursuant to HSR or any other  Applicable Law, and (ii) observe all applicable waiting periods before such nomination is deemed  to have occurred, however for clarity Genentech will be deemed to have timely exercised such  nomination right if Genentech provides that nomination notice prior to expiration of the nomination  period. Each Party shall bear its own costs (including counsel or other expert fees) with respect  to preparing, executing and filing such documents. Subject to the terms and conditions of this  Agreement, each Party shall use all reasonable efforts to take, or cause to be taken, all  reasonable actions and to do, or cause to be done, all things necessary and appropriate to  consummate the nomination of the Subsequent Target(s).    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 49 -  21.4 Assignment  Neither Party shall have the right to assign the present Agreement or any part thereof to any Third  Party other than Affiliates without the prior written approval of the other Party which shall not  unreasonably be withheld, provided however, if a Party is acquired or is to be acquired by a third  party by merger, acquisition, or the sale of substantially all of the assets of the division of such  Party to which the subject matter of this Agreement relates, then such Party may effect such an  assignment or transfer to such acquiring Third Party without the consent of the other Party.    21.5 Debarment  Each Party represents and warrants that it has never been debarred or otherwise sanctioned by  the FDA, or a corresponding regulatory authority.  Neither Party has been debarred under 21  U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health  Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal  Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared  ineligible from any other similar Federal or state agency or program. In the event either Party  receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification  under the above-referenced statutes, such Party shall immediately notify the other Party in writing  and such other Party shall have the right, but not the obligation, to terminate this Agreement,  effective, at such Party’s option, immediately or at a specified future date.    21.6 Independent Contractor  No employee or representative of either Party shall have any authority to bind or obligate the other  Party to this Agreement for any sum or in any manner whatsoever or to create or impose any  contractual or other liability on the other Party without said Party's prior written approval. For all  purposes, and notwithstanding any other provision of this Agreement to the contrary, Pieris’ legal  relationship to Genentech under this Agreement shall be that of independent contractor.    21.7 Unenforceable Provisions and Severability  If any of the provisions of this Agreement are held to be void or unenforceable, then such void or  unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve  as far as possible the economic business intentions of the Parties. However the remainder of this  Agreement will remain in full force and effect, provided that the material interests of the Parties  are not affected, i.e. the Parties would presumably have concluded this Agreement without the  unenforceable provisions.    21.8 Waiver  The failure by either Party to require strict performance and/or observance of any obligation, term,  provision or condition under this Agreement will neither constitute a waiver thereof nor affect in  any way the right of the respective Party to require such performance and/or observance. The  waiver by either Party of a breach of any obligation, term, provision or condition hereunder shall  not constitute a waiver of any subsequent breach thereof or of any other obligation, term, provision  or condition.    21.9 Appendices  All Appendices to this Agreement shall form an integral part to this Agreement.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 50 -    21.10 Entire Understanding  This Agreement contains the entire understanding between the Parties hereto with respect to the  within subject matter and supersedes any and all prior agreements, understandings and  arrangements, whether written or oral.    21.11 Amendments  No amendments of the terms and conditions of this Agreement shall be binding upon either Party  hereto unless in writing and signed by both Parties.    21.12 Invoices  All invoices that are required or permitted hereunder shall be in writing and sent by Pieris to  Genentech at the following address or other address as Genentech may later provide:    Genentech USA  PO Box 4354  Portland, OR 97208-4354  Attn: (name of a Genentech contact at time of invoice, e.g. the Alliance Director)  and via email to the Alliance Director with a copy to [***].     21.13 Notice  All notices that are required or permitted hereunder shall be in writing and sufficient if delivered  personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified  mail or overnight courier), sent by nationally recognized overnight courier or sent by registered or  certified mail, postage prepaid, return receipt requested, addressed as follows:    if to Pieris, to:    Pieris Pharmaceuticals GmbH  Zeppelinstraße 385399 Hallbergmoos  Germany  Attn:   [***]  Email: [***]     and: Pieris Pharmaceuticals, Inc.  255 State Street, 9th floor  Boston, MA 02109  U.S.A  Attn: [***]  Email: [***]        If to Genentech, to: Genentech, Inc.  1 DNA Way  South San Francisco, California 94080  U.S.A.  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 51 -  Attn.  [***]  Facsimile No.: +1 650 467-9146    with a copy to: Genentech, Inc.  1 DNA Way  South San Francisco, California 94080  U.S.A.  Attn.  [***]  Facsimile No.: +1 650 467-3294    or to such other address as the Party to whom notice is to be given may have furnished to the  other Party in writing in accordance herewith.    [Signature Page Follows]    





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]      115115649v.2  - 52 -  IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Effective Date.      Pieris Pharmaceuticals GmbH        /s/ Stephen Yoder ____________________  Name: Stephen Yoder  Title: Managing Director                  Pieris Pharmaceuticals, Inc.        /s/ Stephen Yoder ____________________  Name: Stephen Yoder  Title: President & CEO                    Genentech, Inc.      /s/ Edward Harrington_________________  Name: Edward Harrington  Title: CFO                





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    CONFIDENTIAL      115115649V.2  Appendix 1.84    Initial Targets    [***]   





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-54  Appendix 1.66    Pieris Background IP  [***]   





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-55  Appendix 1.68    Pieris Platform Background IP    [***]       





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-56  Appendix 1.78 (A)    Research Plan for NOTCH2    [***]         





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-57  Appendix 1.78 (B)    Research Plan for C3    [***]     





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-58  Appendix B  Target Candidate Profile (C3)  [***]           





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-59    Appendix 3.1.21.84     Reserved targets    [***]   





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-60    Appendix 18.3     Press Release      PRESS RELEASE  Pieris Pharmaceuticals Announces Respiratory and Ophthalmology Collaboration with  Genentech  • Pieris will receive $20 million as an upfront payment and is eligible to receive  more than $1.4 billion in additional potential milestone payments plus royalties for  commercialized programs  • Collaboration includes initial programs in respiratory disease and ophthalmology,  with opportunity to nominate additional programs  BOSTON, MA, May  XX, 2021 - Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage  biotechnology company advancing novel biotherapeutics through its proprietary Anticalin®  technology platform for respiratory diseases, cancer, and other indications, today announced it  has entered into a multi-program research collaboration and license agreement with Genentech,  a member of the Roche Group, to discover, develop and commercialize locally delivered  respiratory and ophthalmology therapies that leverage Pieris’ proprietary Anticalin® technology.  The research collaboration will enable Pieris to combine its robust discovery engine with  Genentech’s target as well as preclinical and clinical development expertise to create novel  therapies for the treatment of respiratory and ophthalmological diseases. These two focus areas  of the collaboration are uniquely suited to the advantages offered by the small size of Anticalin  proteins when delivered locally.  “We look forward to working closely with Genentech on the development of new inhaled and  ophthalmological treatments based on the Anticalin platform. This collaboration further expands  our partnered efforts in respiratory diseases and opens a new avenue for our Anticalin technology  to potentially provide patient benefit through local biological effects. This is our second respiratory  alliance with a major biopharma company, and we remain deeply committed to inhaled biologics,  which have already shown benefit in the clinic. We also look forward to pursuing another local  application of our technology in ophthalmology, where Genentech has extensive capabilities,”  said Stephen S. Yoder, President and Chief Executive Officer of Pieris.      “Genentech has a longstanding commitment to understanding the underlying biology of  respiratory and ocular diseases and translating this expertise into treatments for patients,” said  James Sabry, M.D., Ph.D., Global Head of Pharma Partnering, Roche. “We are excited to partner  with Pieris Pharmaceuticals to advance potential new therapies that we hope could make a  significant difference in the lives of people who need them.”  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-61  Under the terms of the agreement, Pieris will receive $20 million as an upfront payment and may  be eligible to receive more than $1.4 billion in additional milestone payments across multiple  programs, as well as tiered royalties for commercialized programs. Pieris will be responsible for  discovery research and early preclinical development of the programs, and Genentech will be  responsible for IND-enabling activities, clinical development, and commercialization of those  programs. Genentech will also have the option to select additional targets in return for an option  exercise fee. The collaboration does not include any of Pieris’ internal programs.  About Pieris Pharmaceuticals:  Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein- based drugs to target validated disease pathways in a unique and transformative way. Our  pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology  multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins  are a novel class of therapeutics validated in the clinic and by partnerships with leading  pharmaceutical companies, including AstraZeneca, Seagen, and Servier. Anticalin® is a  registered trademark of Pieris. For more information, visit www.pieris.com.    Pieris Forward Looking Statements:  This press release contains forward-looking statements as that term is defined in Section 27A of  the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,  as amended. Statements in this press release that are not purely historical are forward-looking  statements. Such forward-looking statements include, among other things, whether the  combination of cinrebafusp alfa with other therapies could address a high medical need in HER2  gastric cancer patients who do not respond to traditional HER2-targeted therapies; whether the  effects of the combination of cinrebafusp alfa with other therapies seen in preclinical studies will  be observed in clinical trials; whether data from patients enrolled to date will be sufficient to inform  the recommended phase 2 dose for the Company's planned proof of concept study of cinrebafusp  alfa in gastric cancer; the expected timing and potential outcomes of the reporting by the Company  of key clinical data from its programs, references to novel technologies and methods and our  business and product development plans, including the Company's cash resources, the  advancement of our proprietary and co-development programs into and through the clinic and the  expected timing for reporting data, making IND filings or achieving other milestones related to our  programs, including PRS-060/AZD1402, cinrebafusp alfa, PRS-344, and PRS-352 and the  expected timing of the initiation of the next stage of cinrebafusp alfa's development in gastric  cancer. Actual results could differ from those projected in any forward-looking statements due to  numerous factors. Such factors include, among others, our ability to raise the additional funding  we will need to continue to pursue our business and product development plans; the inherent  uncertainties associated with developing new products or technologies and operating as a  development stage company; our ability to develop, complete clinical trials for, obtain approvals  for and commercialize any of our product candidates, including our ability to recruit and enroll  patients in our studies; our ability to address the requests of the U.S. Food and Drug  Administration; competition in the industry in which we operate; delays or disruptions due to  COVID-19; and market conditions. These forward-looking statements are made as of the date of  this press release, and we assume no obligation to update the forward-looking statements, or to  update the reasons why actual results could differ from those projected in the forward-looking  statements, except as required by law. Investors should consult all of the information set forth  





 






[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this  exhibit have been omitted by means of marking such portions with asterisks as the  identified confidential portions (i) are not material and (ii) would be competitively harmful  if publicly disclosed.]    Pieris - Genentech Research Collaboration Agreement     Appendix-62  herein and should also refer to the risk factor disclosure set forth in the reports and other  documents we file with the Securities and Exchange Commission available at www.sec.gov,  including without limitation the Company's Annual Report on Form 10-K for the fiscal year ended  December 31, 2020 and the Company's Quarterly Reports on Form 10-Q.       Investor Relations Contact:    Pieris Pharmaceuticals, Inc.    Maria Kelman    Executive Director, Investor Relations    +1 857 362 9635    kelman@pieris.com