Document:

pieris-bpexclusiveproduc

EXHIBIT 10.1    [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.]    Execution Version                                        EXCLUSIVE PRODUCT LICENSE AGREEMENT BY AND BETWEEN    PIERIS PHARMACEUTICALS INC., PIERIS PHARMACEUTICALS GMBH    AND    BP ASSET XII, INC.    

 

[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.]    Execution Version  Page 2 of 94      GDSVF&H\6023374.4  TABLE OF CONTENTS     1. DEFINITIONS. ......................................................................................................................... 4  2. LICENSE GRANTS ............................................................................................................... 23  3. GOVERNANCE, REPORTING & DECISION-MAKING ................................................ 25  4. DEVELOPMENT & MANUFACTURING ......................................................................... 26  5. REGULATORY ...................................................................................................................... 29  6. COMMERCIALIZATION .................................................................................................... 30  7. DILIGENCE & NON-COMPETE ........................................................................................ 31  8. PAYMENTS ............................................................................................................................ 32  9. INTELLECTUAL PROPERTY ............................................................................................ 44  10. CONFIDENTIALITY & PUBLICATION ......................................................................... 51  11. REPRESENTATIONS & WARRANTIES ........................................................................ 55  12. INDEMNIFICATION, LIABILITY & INSURANCE ...................................................... 59  13. TERM AND TERMINATION ............................................................................................ 65  14. MISCELLANEOUS ............................................................................................................. 71         

 

[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.]    Execution Version  Page 3 of 94      GDSVF&H\6023374.4  This Exclusive Product License Agreement (the “Agreement”), entered into as of April  24, 2021 (the “Effective Date”) by and between Pieris Pharmaceuticals, Inc. (“Pieris US”), a  corporation existing under the laws of the State of Nevada having a principal place of business at  255 State Street, 9th Floor, Boston, MA 02109, Pieris Pharmaceuticals GmbH (“Pieris  Germany”), a company existing under the laws of Germany having a principal place of business  at Zeppelinstraße 3, 85399 Hallbergmoos, Germany (Pieris US and Pieris Germany are  collectively referred to as “Pieris”) and BP Asset XII, Inc., a corporation existing under the laws  of the state of Delaware having a principal place of business at 55 Cambridge Parkway, Suite 400,  Cambridge, MA 02142 (“BP”). Pieris and BP are referred to in this Agreement individually as a  “Party” and collectively as the “Parties”.     RECITALS    Whereas, Pieris is engaged in the discovery, research, development, and manufacture of  Anticalin-based proteins and possesses proprietary technology, know-how and intellectual  property rights relating thereto;    Whereas, BP possesses expertise in developing and manufacturing pharmaceutical  products; and    Whereas, BP wishes to license from Pieris and Pieris wishes to license to BP, on an  exclusive basis, the right to research, develop and commercialize Products (as defined herein).    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:     

 

[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.]    Execution Version  Page 4 of 94      GDSVF&H\6023374.4  1. DEFINITIONS.   The following capitalized terms or derivatives thereof (verbs, nouns, singular, plural),  when used in this Agreement, shall have the following meanings:     “Accelerated Approval” means a drug candidate approved under FDA’s accelerated  approval pathway (Section 506(c) of the FD&C Act) (or foreign equivalent).   “Accounting Standards” means the International Financial Reporting Standards  (“IFRS”), the U.S. Generally Accepted Accounting Principles (“U.S. GAAP”), and any  other internationally recognized accounting standards.   “Acquiror” has the meaning set forth in Section 14.4.    “Affiliate” means 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 the definitions of “Affiliate,” “BP Parent Entity” and “BP Restricted  Entities” only, the term “control” means 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 entity whether  through the ownership of voting securities, by contract, resolution, regulation or otherwise.   “Agreement” means this document including any and all exhibits and amendments to  it as may be added and/or amended from time to time in accordance with the provisions of  this Agreement.    “Alliance Manager” has the meaning set forth in Section 3.1.    “Antibody” means any monoclonal or polyclonal antibody, whether multiple or single  chain, recombinant or naturally occurring, whole or fragment, and any variants, derivatives  or constructs thereof, including but not limited to, antigen binding portions including Fab,  Fab’, F(ab’)2, Fv, dAb and CDR fragments, single chain antibodies (scFv), chimeric  antibodies, diabodies and polypeptides (including any humanized versions thereof) that  contain at least a portion of an immunoglobulin that is sufficient to bind selectively to a  specific antigen, including a Target. For the avoidance of doubt, an Antibody Building  Block is an Antibody.    “Antibody Building Block” means the Antibody used in a Product.    “Anticalin” or “Anticalin protein” means, (a) any lipocalin mutein isolated from the  Anticalin Libraries, or (b) 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 (a) of this definition, in each case, which binds and  

 

[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.]    Execution Version  Page 5 of 94      GDSVF&H\6023374.4  recognizes a specific target. For the sake of this Section, “lipocalin mutein” means a protein  arising as a result of a mutation or a recombinant DNA procedure.   “Anticalin Affinity Maturation” means the process of engineering an Anticalin  protein to enhance its developability profile by improving binding activity, specificity, in  vitro potency, in vivo potency, expression behavior in a bacterial or mammalian host (with  regard to, e.g., monomer content, amount), stability, solubility, immunogenicity profile,  and PK parameters for the Anticalin by introducing, e.g., one or more amino acid  mutations.    “Anticalin Building Block” means the Anticalin protein used in a Product.   “Anticalin Characterization” means the assessment of Anticalin protein features  including binding, functional potency in vitro and/or in vivo, as well as the evaluation of  further developability profile of Anticalin proteins including expression behavior in a  bacterial or mammalian host, stability, solubility, immunogenicity profile, and PK profile.   “Anticalin Expression” means heterologous expression of an Anticalin protein in a  host cell.   “Anticalin Libraries” means any phage or yeast display library based on (a) the  [***] lipocalin ([***]) or (b) the [***] lipocalin ([***]).   “Anticalin Selection” means the process of screening an Anticalin Library with a  defined target through the process of phage or yeast display, within a solution, and  physically separating the target, containing binding Anticalin proteins, from the solution  containing non-binding Anticalin proteins.   “Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as  amended, the UK Bribery Act 2010, as amended, and any other applicable anticorruption  laws and other Applicable Law for the prevention of fraud, racketeering, money laundering  or terrorism.    “API” has the meaning set forth in Section 8.6.2.   “Applicable Law” means any law, statute, ordinance, code, rule or regulation that  has been enacted by a Governmental Authority (including any Regulatory Authority  (including the United States Securities and Exchange Commission (“SEC”)) and is in force  as of the Effective Date or comes into force during the Term, in each case to the extent that  the same is applicable to either Party (including the performance by such Party of its  obligations under this Agreement).   “Arising IP” means collectively, Arising Know-How, Arising Patents and all  

 

[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.]    Execution Version  Page 6 of 94      GDSVF&H\6023374.4  Intellectual Property Rights therein, but specifically excludes any and all Pieris Building  Block IP and Pieris Platform Improvement IP.    “Arising Know-How” means all Know-How generated by or on behalf of either  Party after the Effective Date in the course of performing activities under the Agreement  or through the use of BP Confidential Information or BP Know-How, but in each case  specifically excludes any and all Pieris Building Block IP and Pieris Platform Improvement  IP.   “Arising Patent” means all Patents protecting Arising Know-How filed during the  term of the Agreement but specifically excludes any and all Pieris Building Block Patents  and Pieris Platform Improvement Patents. Any Arising Patents that are filed during the  term of the Agreement shall be listed in Exhibit 1.21 as updated from time to time.    “Audit” has the meaning set forth in Section 12.8.6.   “Bankruptcy Code” has the meaning set forth in Section 13.3.3.   “Biologic” means a peptide of at least ten (10) amino acids.   “Biosimilar” means, with respect to a given Product in a given country of the  Territory, any biological product on the market in such country that is approved (a) by the  applicable Regulatory Authority in such country under the biosimilarity standard set forth  in the United States under 42 U.S.C. §§262(i)(2) and (k), or any similar standard under its  foreign equivalent Applicable Law, on a country-by-country basis where such Product is  marketed, provided that such Applicable Law exists; and (b) in reliance in whole or in part,  on a prior Marketing Approval (or on any safety or efficacy data submitted in support of  such prior Marketing Approval) of such Product. For countries or jurisdictions where no  explicit biosimilar regulations exist, Biosimilar includes any product which has been  deemed to be a Biosimilar by a Regulatory Authority in another country or jurisdiction.  Any product or component thereof (including any Product or component thereof) licensed,  marketed, sold, manufactured, or produced by or on behalf of a Party, its Affiliates or  (sub)licensees will not constitute a Biosimilar.   “Boston Pharma” means Boston Pharma Holdings, LLC a limited liability company  existing under the laws of the state of Delaware.   “[***]” has the meaning set forth in Section 12.5.1.   “BP” has the meaning set forth in the preamble.   “BP Conducted Activities” means any and all Research, Development,  Manufacturing, Commercialization or other preclinical and/or clinical activities related to  

 

[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.]    Execution Version  Page 7 of 94      GDSVF&H\6023374.4  the Product that are not Pieris Conducted Activities.   “BPInc” means Boston Pharmaceuticals, Inc. a corporation existing under the laws  of the state of Delaware.   “[***]” has the meaning set forth in Section 12.5.2.   “BP Indemnitees” has the meaning set forth in Section 12.2.   “BP Monetary Obligations” has the meaning set forth in Section 12.5.1.   “BP Patent” has the meaning set forth in Section 9.3.7.   “BP Parent Entity” means an Affiliate of BP which is not a BP Restricted Entity.  For the avoidance of doubt, any Person who controls (but is not controlled by) Boston  Pharma is a BP Parent Entity.    “BP Performance Obligations” has the meaning set forth in Section 12.5.2.   “BP Restricted Entity” means Boston Pharma and any Person controlled by Boston  Pharma.   “BP Restricted Individual” means any employee, contractor or consultant of a BP  Restricted Entity who is at the relevant time (or who has been within the immediately  preceding [***] month period to such relevant time) materially involved in the Research  or Development of the Product.   “Building Block” means, individually, the Antibody and the Anticalin proteins used  in the Product. A Building Block can be either an Antibody Building Block or an Anticalin  Building Block.    “Business Day” means a day other than a Saturday, Sunday, or a bank or other public  holiday in Munich, Germany or Boston, Massachusetts.    “Calendar Quarter” means the respective periods of three (3) consecutive calendar  months ending on March 31, June 30, September 30 and December 31 of each Calendar  Year.   “Calendar Year” means each successive period of twelve (12) months commencing  on January 1 and ending on December 31.   “China” means the PRC, Hong Kong, Macau, and Taiwan.    “Change of Control” means with respect to a Party, (a) completion of a merger,  

 

[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.]    Execution Version  Page 8 of 94      GDSVF&H\6023374.4  reorganization, amalgamation, arrangement, share exchange, consolidation, tender or  exchange offer, private purchase, business combination, recapitalization, or other  transaction involving such Party as a result of which either (1) the stockholders of such  Party immediately preceding such transaction hold less than [***] percent ([***]%) of the  outstanding shares, or less than [***] percent ([***]%) of the outstanding voting power,  respectively, of the ultimate company or entity resulting from such transaction immediately  after consummation thereof (including a company or entity which as a result of such  transaction owns the then-outstanding securities of such Party or all or substantially all of  such Party’s assets, including such Party’s assets related to the Product, either directly or  through one or more subsidiaries), or (2) any single Third Party person or group (within  the meaning of the U.S. Securities Exchange Act of 1934 and the rules of the SEC  thereunder as in effect, referred to as a “Group”) holds [***] percent ([***]%) or more of  the outstanding shares or voting power of the ultimate company or entity resulting from  such transaction immediately after the consummation thereof (including a company or  entity which as a result of such transaction owns the then-outstanding securities of such  Party or all or substantially all of such Party’s assets either directly or through one or more  subsidiaries); or (b) the direct or indirect acquisition (including by means of a tender offer  or an exchange offer) by any Third Party person or Group of beneficial ownership (within  the meaning of the U.S. Securities Exchange Act of 1934 and the rules of the SEC  thereunder as in effect), or the right to acquire beneficial ownership, or formation of any  Third Party Group which beneficially owns or has the right to acquire beneficial ownership,  of [***] percent ([***]%) or more of either the outstanding voting power or the then  outstanding shares of such Party, in each case on a fully-diluted basis. Notwithstanding the  foregoing, “Change of Control” shall not include any of the following transactions: (i) any  Equity Financing; or (ii) any transaction or series of related transactions with one or more  Affiliates (but no Third Parties). For the avoidance of doubt, a transaction solely to change  the domicile of a Party shall not constitute a Change of Control as long as there is no change  of direct or indirect shareholding.   “Change of Control Revenue Period” has the meaning set forth in Section 8.7.1.    “Change of Control Revenue Share” has the meaning set forth in Section 8.7.1.    “Clinical PoC” means database lock of the Phase 2 Study dose expansion set forth  in the Initial Product Development Plan or an equivalent Phase 1b Study or Phase 2 Study  in the Product Development Plan.    “Clinical Study” means a Phase 1 Study, Phase 1b Study, Phase 2 Study, Phase 3  Study, or other study (including a non-interventional study) in humans to obtain  information regarding the product, including information relating to the safety, tolerability,  pharmacological activity, pharmacokinetics, dose ranging, or efficacy of a Product.   “CMC” means chemistry, manufacturing, and control.  

 

[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.]    Execution Version  Page 9 of 94      GDSVF&H\6023374.4   “COC Consideration” means Consideration in connection with any Change of  Control of BP.   “COC Notice” has the meaning set forth in Section 14.5.1.   “COC Acquiror” has the meaning set forth in Section 14.5.1.   “[***]” has the meaning set forth in Section 4.6.5.   “Co-Invented Arising Patent” means any Arising Patent where one or more  inventors listed on such Patent is an employee, consultant, or contractor of Pieris.  Inventorship shall be determined in accordance with U.S. law. For the avoidance of doubt,  BP shall exclusively own all rights, title and interests in and to Co-Invented Arising  Patents.   “Commercially Reasonable Efforts” means: (a) with respect to the efforts to be  expended by a Party with respect to any objective, such reasonable, diligent, and good faith  efforts as such Party would normally use to accomplish a similar objective under similar  circumstances; and (b) with respect to any objective relating to Exploitation of a Product,  such level of efforts, consistent with the exercise of prudent scientific and business  judgment, required to carry out such obligation in a sustained manner consistent with the  efforts BP or Pieris, as applicable, devotes at the same stage of development or  commercialization, as applicable, for its pharmaceutical products in a similar area with  similar profit potential, at a similar stage of their product life without regard to any  payments owed under this Agreement or the payments owed in connection with its other  pharmaceutical products but taking into account, without limitation, commercial, legal and  regulatory factors, target product profiles, product labeling, past performance, the  regulatory environment and competitive market conditions in the therapeutic area, safety  and efficacy of such Product, and the strength of its proprietary position. 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. For clarity,  “Commercially Reasonable Efforts” will not mean that a Party guarantees that it will  actually accomplish the applicable task or objective. In the case of BP, “Commercially  Reasonable Efforts” includes the efforts that Boston Pharma would normally use to  accomplish a similar objective under similar circumstances for any of its Affiliates with  respect to any objective, including objectives related to exploitation of the Product.    “Commercialization” or “Commercialize” means any and all activities directed to  marketing, promoting, distributing, importing, exporting, using, offering to sell or selling  a product, as applicable.   “Competing Product” means any [***] that [***] and [***] the [***]. For purposes  of this Agreement, the term “therapeutically relevant” means that the modulation of a given  

 

[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.]    Execution Version  Page 10 of 94      GDSVF&H\6023374.4  Target is reasonably believed to be responsible, in whole or in part, for a specific aspect of  the safety or efficacy of such product [***].   “Completion” or “Completed” means with respect to a Clinical Study, the  availability of topline data generated from such Clinical Study.    “Confidential Information” means any and all Know-How, information and Data  of a confidential nature, whether financial, business, legal, technical or non-technical,  whether in oral, written, electronic or other form, including information and data related to  a Product, a Party, or any concepts, discoveries, inventions, data, designs or formulae in  relation to this Agreement, that is disclosed, supplied or otherwise made available by or on  behalf of one Party or any of its Affiliates or Sublicensees (“Disclosing Party”) to the other  Party or any of its Affiliates or Sublicensees (“Receiving Party”) in connection with this  Agreement. All Confidential Information disclosed by a Party pursuant to the Confidential  Agreement between Pieris and BP dated [***] (the “Prior CDA”) shall be deemed to be  Confidential Information of the applicable Party pursuant to this Agreement, and the terms  of this Agreement shall exclusively govern the use and disclosure thereof and supersede  the terms of such Prior CDA with respect to such Confidential Information. For avoidance  of doubt, the Pieris Platform Know-How, the Pieris Platform Improvement Know-How,  and the Pieris Building Block Know-How are and shall remain the Confidential  Information of Pieris.    “Consideration” means anything of value actually received (including any value  received after termination of this Agreement) by BP or its Affiliates or holders of its capital  stock or holders of rights to acquire its capital stock in connection with any Sublicense or  Change of Control of BP (in the case of a Sublicense, such Consideration, “Sublicense  Consideration” and in the case of a Change of Control such Consideration, “COC  Consideration”) (regardless of how allocated, the form of consideration or when received)  including: (i) [***]; (ii) [***]; (iii) [***]; (iv) [***]; and (v) [***]; and (vi) [***]. For  clarity, there shall be no double counting with respect to any of the items set forth above.  For avoidance of doubt, in the case of a Sublicense, to the extent that the Sublicensee [***]  (as determined in accordance with Accounting Standards) shall be considered  Consideration. In addition, the value of any non-cash consideration, other than securities  of a class which is publicly traded, shall be the fair market value thereof as of the date of  closing of the applicable Sublicense. For the avoidance of doubt, any publicly traded  securities received by BP in connection with any Sublicense shall be valued [***].     “Control”, “Controlled” or “Controlling” means, with respect to a subject item  (including any Intellectual Property Right, Know-How, Data, Marketing Approvals or  Regulatory Materials) (“Subject Item”), the possession (whether arising by ownership,  pursuant to a license or sublicense or otherwise, other than pursuant to this Agreement) by  a Party of the ability of such Party or its Affiliate to grant a license, sublicense or access to  the other Party with respect to such Subject Item, as provided in this Agreement, without  

 

[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.]    Execution Version  Page 11 of 94      GDSVF&H\6023374.4  violating the terms of any agreement or other arrangement with any Third Party, in  existence as of the time such Party or its Affiliates would first be required hereunder to  grant the other Party such license, sublicense or access.    “Copyrights” means all copyrights, and all right, title and interests in all copyrights,  copyright registrations and applications for copyright registration, certificates of copyright  and copyrighted rights and interests throughout the world, and all right, title and interest in  related applications and registrations throughout the world.   “Costs” means both internal and external costs and expenses (including the cost of  allocated FTEs at the FTE Rate and Out-of-Pocket Costs).   “Cover,” “Covered” or “Covering” means, with respect to the applicable invention,  discovery, process or product (including a Product), as appropriate, (a) a Patent, that, in the  absence of a (sub)license under, or ownership of, such Patent, the Development,  Manufacture or Commercialization of such invention, discovery, process or product  (including making, using, offering for sale, selling or importing thereof), as appropriate,  with respect to a given country, would infringe such Patent (or, in the case of a Patent that  has not yet issued, would infringe any then-pending claim in such Patent if it were to issue  with such claim), and (b) 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.   “CREATE Act” has the meaning set forth in Section 9.5.    “Data” means any and all non-aggregated and aggregated research, pharmacology,  pre-clinical, clinical, commercial, marketing, process development, Manufacturing and  other data or information, including investigator brochures and reports (both preliminary  and final), statistical analyses, expert opinions and reports, and safety data, in each case  generated from, or related to, Clinical Studies or non-clinical studies, research or testing  specifically related or directed to a Product. For the avoidance of doubt, Data shall be  deemed Confidential Information of the Disclosing Party for the purposes of this  Agreement and subject to Section 10.1 of this Agreement.   “Development” or “Develop” means any and all clinical drug development activities  conducted before or after obtaining Marketing Approval that are reasonably related to or  leading to the development, preparation, and submission of data and information to a  Regulatory Authority for the purpose of obtaining, supporting or expanding Marketing  Approval or to the appropriate body for obtaining, supporting or expanding pricing  approval, including all activities related to pharmacokinetic profiling, design and conduct  of Clinical Studies, regulatory affairs, statistical analysis, report writing, and regulatory  

 

[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.]    Execution Version  Page 12 of 94      GDSVF&H\6023374.4  filing creation and submission (including the services of outside advisors and consultants  in connection therewith).    “Developmental Milestone Event” has the meaning set forth in Section 8.2.   “Developmental Milestone Payment” has the meaning set forth in Section 8.2.    “Disclosing Party” has the meaning set forth in Section 10.1.1.   “Dispute” has the meaning set forth in Section 14.1.1.    “Dollars” or “$” means the lawful currency of the United States.   “Early Launch Date” has the meaning set forth in Section 8.6.2.   “Effective Date” has the meaning set forth in the Preamble.   “EMA” means the European Medicines Agency or any successor to the European  Medicines Agency.   “European Union” or “EU” means the member states of the European Union as of  the Effective Date and the United Kingdom, and such other countries as may become part  of the European Union after the Effective Date.    “Effective Date” has the meaning set forth in the preamble.    “Equity Financing” means any issuance, sale or distribution of capital stock of BP  or any of its Affiliates at its then-current fair market value, in any transaction or series of  transactions that include(s) participation by at least one Third Party and which transaction  is engaged in primarily for equity financing purposes, the proceeds of which shall be  deployed to Exploit the Product or otherwise expensed in the business of BP (including an  underwritten public offering of any of BP or any of its Affiliate’s capital stock).    “Equity Financing Consideration” has the meaning set forth in Section 8.7.3.   “Equity Financing Revenue Share” has the meaning set forth in Section 8.7.3.   “Exploitation” or “Exploit” means make, have made, use, have used, offer for sale,  have offered for sale, sell, have sold, import, have imported, Research, have Researched,  Develop, have Developed, Manufacture, have Manufactured, Commercialize, have  Commercialized and otherwise exploit. For the avoidance of doubt, Exploitation or Exploit  may mean any or all of the foregoing, as the context requires.   “FDA” means the United States Food and Drug Administration or a successor to the  

 

[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.]    Execution Version  Page 13 of 94      GDSVF&H\6023374.4  United States Food and Drug Administration.   “Field” means all therapeutic and diagnostic uses.   “Finished Product” means a Product in its finished, labeled, assembled, and  packaged form, ready for sale to the market or use in clinical trials (including Clinical  Studies) or pre-clinical studies, as the case may be.   “First Commercial Sale” means, on a Product-by-Product and country-by-country  basis, the first commercial sale in an arms’ length transaction of a Product to a Third Party  by a Party or any of its Affiliates in such country following receipt of applicable Marketing  Approval of such Product in such country. For clarity, the “First Commercial Sale” shall  not include any distribution or other sale solely for patient assistance, named patient use,  compassionate use, or test marketing programs or non-registrational studies or similar  programs or studies where the Product is supplied without charge or at the actual  Manufacturing cost thereof (without allocation of indirect costs or any markup).   “FTE” means full-time equivalent person-year of work performing activities  hereunder and working [***]. For clarity, indirect personnel (including support functions  such as legal or business development) shall not constitute “FTEs.”   “FTE Costs” for a given period means the product of (a) the total FTEs  (proportionately, on a per-FTE basis) dedicated by a Party or its Affiliates in the particular  period to the direct performance of the activities allocated to such Party hereunder and (b)  the FTE Rate.   “FTE Rate” means, unless otherwise agreed between the Parties, a rate per FTE  equal to [***] Dollars ($[***]) per annum (which may be prorated on a daily or hourly  basis as necessary).    “GLP” means the then-current practices and procedures set forth in Title 21, United  States Code of Federal Regulations, Part 58 (as amended), and any other regulations,  guidelines or guidance documents relating to good laboratory practices, or any foreign  equivalents thereof in the country in which such studies or clinical trials (including Clinical  Studies) are conducted or that are otherwise applicable.   “GLP Tox Study” means, with respect to a Product, a study conducted in a species  using applicable GLP for the purposes of assessing the efficacy, safety or the onset,  severity, and duration of toxic effects and their dose dependency with the goal of  establishing a profile sufficient to support the filing of an IND.   “Governmental Authority” means any applicable government authority, court,  tribunal, arbitrator, agency, department, legislative body, commission or other  

 

[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.]    Execution Version  Page 14 of 94      GDSVF&H\6023374.4  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.   “Government Official” means any Person employed by or acting on behalf of a  government, government-controlled entity or public international organization; any  political party, party official or candidate; any Person who holds or performs the duties of  an appointment, office or position created by custom or convention; and any Person who  holds himself or herself out to be the authorized intermediary of any of the foregoing.   “Improper Action” has the meaning set forth in Section 12.8.1.2.   “Indemnification Claim Notice” has the meaning set forth in Section 12.3.    “Indemnified Party” has the meaning set forth in Section 12.3.    "Initial Product Development Plan" has the meaning set forth in Section 4.1.    “Initiation” or “Initiated” means, (a) with respect to a Clinical Study of a Product,  the first dosing of the first human subject pursuant to the protocol for such Clinical Study  or (b) with respect to a GLP Tox Study, the start date of the in-life phase of such GLP Tox  Study.   “IND” means (a) an Investigational New Drug Application as defined in the United  States Federal Food, Drug and Cosmetic Act (“FD&C Act”) and Applicable Law  promulgated thereunder by the FDA, (b) the Investigational Medicinal Product Dossier  (“IMPD”) in the European Union, or (c) the equivalent application to the applicable  Regulatory Authority in any other regulatory jurisdiction, and any amendments to the  foregoing (a), (b) or (c), in each case, the filing of which is necessary to initiate or conduct  clinical testing of an investigational drug or biological product in humans in such  jurisdiction.   “Indication” means a distinct type of disease or medical condition in humans to  which a Product is directed and eventually approved. To distinguish one Indication from  another Indication, the two Indications have to be [***]. Notwithstanding the foregoing:  (a) [***]; and (b) [***]. For avoidance of doubt, [***].   “Indirect Taxes” means value added, sales, consumption, goods and services taxes  or similar taxes required by Applicable Law to be disclosed as a separate item on the  relevant invoice.   “Infringement Action” has the meaning set forth in Section 9.7.2.   “Intellectual Property Rights” means, collectively, Patents, Copyrights,  Trademarks, designs, domain names, moral rights and all other intellectual property and  

 

[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.]    Execution Version  Page 15 of 94      GDSVF&H\6023374.4  proprietary rights.   “Insolvent Party” has the meaning set forth in  Section 13.3.3.   “Key IP” has the meaning set forth in Section 9.3.2.1.    “Know-How” means all technical and other information and any document in  which the foregoing is recorded, which at the time it is disclosed pursuant to this Agreement  is not in the public domain, including ideas, concepts, inventions, discoveries, data  (including Data), formulae, specifications, information relating to any materials,  procedures for experiments and tests, results of experimentation and testing, computer  programs or algorithms, results of any aspect of Exploitation including laboratory records  and data analyses.   “Known Third-Party Obligations” means any agreement in place as of the  Effective Date that licenses to Pieris Intellectual Property Rights that Cover the  Commercialization of the Product. The Known Third-Party Obligations are the Product  Cell Line License and the [***].    “Losses” has the meaning set forth in Section 12.1.   “MAA” means a Marketing Authorization Application, in relation to any Product,  filed or to be filed with the FDA, EMA or equivalent national agency, for authorization to  place a medicinal product on the market in the United States, European Union, or any other  territory. For avoidance of doubt, an MAA in the United States is a Biological License  Application (“BLA”) as described in Section 351(a) of the United States Public Health  Service Act (“PHS Act”), or an abbreviated Biological License Application as described  in Section 351(k) of the PHS Act.   “Manufacture” or “Manufacturing” means all activities related to the  manufacture of Product, including manufacturing supplies for Research, Development or  Commercialization, packaging, in-process and Finished Product testing, pharmaceutical  development including process development and validation, release of product, or any  component or ingredient thereof, quality assurance and quality control activities related to  manufacturing and release of product, ongoing stability tests, storage, shipment, and  regulatory activities related to any of the foregoing.   “Marketing Approval” means all approvals, licenses, registrations or  authorizations of the Regulatory Authorities in a country, necessary for the commercial  marketing and sale of the Product in such country, including the approval of an MAA or a  BLA and pricing.   “Material Anticalin Communication” means any communication (including  

 

[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.]    Execution Version  Page 16 of 94      GDSVF&H\6023374.4  meetings) with Regulatory Authorities and Regulatory Authority questions or concerns  regarding significant issues, including any of the following: key Product quality attributes  (e.g., purity), significant safety findings, significant clinical or nonclinical findings  affecting patient safety, or significant efficacy or lack of efficacy, in each case with respect  to a Product, that could materially affect Anticalin proteins per se (e.g., serious adverse  events, emerging safety signals).   “Material Product Communication” means any communication (including  meetings) with Regulatory Authorities and Regulatory Authority questions or concerns  regarding significant issues, including any of the following: key quality attributes (e.g.,  purity), significant safety findings, significant clinical or nonclinical findings affecting  patient safety, or significant efficacy or lack of efficacy, in each case with respect to a  product that contains the same Anticalin Building Block as the Product and could  materially affect the Product (e.g., serious adverse events, emerging safety signals).    “Net Sales” means the gross invoiced amount on sales of Product by or on behalf  of BP, its Affiliates, and its Sublicensees to Third Parties (which Third Parties will include  distributors) after deduction of the following amounts, to the extent taken:   (a) [***];   (b) [***];   (c) rebates and similar payments made with respect to sales paid for by any  Governmental or Regulatory Authority such as, by way of illustration and not in  limitation of the Parties’ rights hereunder, Federal or state Medicaid, Medicare or  similar state program in the United States or equivalent governmental program in  any other country;   (d) [***];  (e) [***];  (f) [***];  (g) [***]; and  (h) the actual cost for transportation costs, distribution expenses, special packaging  and related insurance charges.   Net Sales (including any deductions) will be calculated using BP’s internal audited systems  used to report such sales as adjusted for any of the items above not taken into account in  such systems, and in each case, which are in accordance with Accounting Standards, fairly  applied and as employed on a consistent basis throughout BP’s operations. [***].  

 

[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.]    Execution Version  Page 17 of 94      GDSVF&H\6023374.4  If a Product is sold as part of a Combination Product (as defined below), the Net Sales from  such Product, for the purposes of determining royalty payments, will be determined by  multiplying the Net Sales (as determined without reference to this paragraph) of the  Combination Product by the fraction A/(A+B), where A is the standard sales price of the  ready-for-sale form of the Product, containing the same amount of the sole active  ingredient as the Combination Product in question, in the given country when sold  separately in finished form; and B is the standard sales price of the ready-for-sale form of  the product containing the same amount of the other therapeutically active ingredient(s)  that is contained in the Combination Product in question, in the given country, each during  the applicable royalty period or, if sales of all compounds did not occur in such period,  then in the most recent royalty reporting period. In the event, however, that if, in a specific  country either or both of the Product and the other therapeutically active ingredient in such  Combination Product are not sold separately in such country, a market price for such  Product and such other active ingredient will be negotiated by the Parties in good faith for  the purposes of performing the calculation above to determine royalty payments on the Net  Sales from such Combination Product. As used above, the term “Combination Product”  means a Product that includes at least one additional therapeutically active ingredient  (whether co-formulated or co-packaged). The same methodology set forth above shall be  used to the extent that there are more than two therapeutically active ingredients that are  part of the Combination Product.   Transfers or dispositions of Product: (i) in connection with patient assistance programs; (ii)  for charitable purposes; (iii) for preclinical, clinical, regulatory or governmental purposes  or under so-called “named patient” or other limited access programs; or (iv) for use in any  tests or studies necessary to comply with any Applicable Law, regulation or request by a  Regulatory Authority shall not, in each case of (i) through (iv), be deemed sales of such  Product for purposes of this definition of “Net Sales.”   “Other Assets” has the meaning set forth in Section 8.7.8.   “Other Pieris IP” has the meaning set forth in Section 9.3.4.   “Out-of-Pocket Costs” means all direct project expenses paid or payable to Third  Parties, which are specifically identifiable and incurred for services or materials provided  by them directly in their performance of applicable activities with respect to a Product;  such expenses to have been recorded as income statement items in accordance with  Accounting Standards and for the avoidance of doubt, not including pre-paid amounts  (until expensed in accordance with Accounting Standards). For clarity, Out-of-Pocket  Costs do not include FTE Costs.   “Party” the meaning set forth in the preamble.   “Party Representatives” has the meaning set forth in Section  12.8.1.  

 

[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.]    Execution Version  Page 18 of 94      GDSVF&H\6023374.4   “Patents” means all patents and patent applications (which for the purpose of this  Agreement shall be deemed to include certificates of invention and applications for  certificates of invention), including all divisionals, continuations, substitutions,  continuations-in-part, re-examinations, reissues, additions, renewals, revalidations,  extensions, registrations and supplementary protection certificates and the like of any such  patents and patent applications, and any and all foreign equivalents of the foregoing.   “Patent Term Extensions” has the meaning set forth in Section 9.9.   “Person” means any corporation, limited or general partnership, limited liability  company, joint venture, trust, unincorporated association, governmental body, authority,  bureau or agency, any other entity or body, or an individual.   “Phase 1 Study” means a clinical study of an investigational product in human  subjects which provides for the first introduction into humans of such investigational  product, conducted in healthy volunteers or patients to obtain information on product  safety, tolerability, pharmacological activity or pharmacokinetics, as described in 21  C.F.R. § 312.21(a), or a comparable clinical study prescribed by the relevant Regulatory  Authority in a country other than the United States. The investigational product can be  administered to patients as a single agent or in combination with other investigational or  marketed agents and a Phase 1 Study shall be deemed commenced when Initiated.   “Phase 1b Study” or “Phase 2 Study” means: (a) the expansion of a Phase 1 Study  to include additional patient(s) following the selection of one or more dose(s) and  regimen(s) during the dose escalation part of the Phase 1 Study (such as a maximum  tolerated dose) or (b) a clinical study of an investigational product that is prospectively  designed to establish the safety, dose ranging and efficacy of a product as further defined  in 21 C.F.R. § 312.21(b), or a comparable clinical study prescribed by the relevant  Regulatory Authority in a country other than the United States.  The investigational product  can be administered to patients as a single agent or in combination with other  investigational or marketed agents and a “Phase 1b Study” or “Phase 2 Study” shall be  deemed commenced when Initiated.   “Phase 3 Study” means a clinical study of an investigational product that is  designed to generate statistically significant evidence of the efficacy of such investigational  product for one or more Indications or uses (as well as additional safety information) and  that is intended to form the primary scientific support for filing a BLA to obtain Marketing  Approval to market the investigational product, (or any MAA for the non-United States  equivalent thereof). The investigational product can be administered to patients as a single  agent or in combination with other investigational or marketed agents and a Phase 3 Study  shall be deemed commenced when Initiated. For clarity, a Phase 1b Study or Phase 2 Study  that enables Accelerated Approval of an investigational product based on surrogate  endpoints is not a Phase 3 Study. For further clarity, “Phase 3 Study” shall also include  

 

[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.]    Execution Version  Page 19 of 94      GDSVF&H\6023374.4  phase 4 confirmatory trials (i.e., any Clinical Study to confirm the anticipated benefit of a  drug that was subject to Accelerated Approval).    “Pieris” has the meaning set forth in the preamble.    “Pieris Building Block IP” means the Pieris Building Block Know-How and the  Pieris Building Block Patents and any Intellectual Property Rights therein.    “Pieris Building Block Know-How” means the Know-How Covering only each  Building Block individually, excluding the Pieris Platform IP and the Pieris Platform  Improvement IP.    “Pieris Building Block Patents” means the Patents Covering only each Building  Block individually, excluding the Pieris Platform IP and the Pieris Platform Improvement  IP. The Pieris Building Block Patents as of the Effective Date are listed on Exhibit 1.128.    “Pieris Conducted Activities” means the activities for which Pieris is designated  as responsible (and which it has agreed to be responsible for) under the Product  Development Plan and Technology Transfer Plan.   “Pieris Germany” has the meaning set forth in the preamble.    “Pieris Indemnitees” has the meaning set forth in Section 12.1.   “Pieris IP” means the Pieris Patents and the Pieris Know-How and any Intellectual  Property Rights therein.   “Pieris Know-How” means all Know-How that is Controlled by Pieris or its  Affiliates as of the Effective Date and thereafter during the Term, other than pursuant to  the licenses granted by BP or its Affiliates or Sublicensees under this Agreement, and is (i)  used in connection with the Exploitation of any Product or (ii) reasonably necessary or  reasonably useful for the Exploitation of any Product.   “Pieris Patents” means any Patents that are Controlled by Pieris or its Affiliates as  of the Effective Date and thereafter during the Term, that Cover the Exploitation of any  Product pursuant to the terms of this Agreement. The Pieris Patents as of the Effective Date  are listed in Exhibit 1.134.    “Pieris Platform Improvement IP” means any and all Know-How created,  invented or generated by or on behalf of employees, agents, or independent contractors of  Pieris or its Affiliates (whether alone or jointly) or BP or its Affiliates during the course of  performing activities pursuant to this Agreement that constitutes an improvement,  modification or enhancement to, or derivative of, the Pieris Platform IP, including any  Intellectual Property Rights subsisting therein for example, Patents (“Pieris Platform  

 

[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.]    Execution Version  Page 20 of 94      GDSVF&H\6023374.4  Improvement Patents”).    “Pieris Platform IP” means Pieris Platform Know-How and the Pieris Platform  Patents.   “Pieris Platform Know-How” means Know-How Controlled by Pieris or its  Affiliates as of the Effective Date or thereafter that is necessary or useful for the practice  of the Pieris Platform Technology.   “Pieris Platform Patents” means those Patents Controlled by Pieris or its Affiliates  as of the Effective Date and thereafter that are necessary or useful to practice the Pieris  Platform Technology. A list of the Pieris Platform Patents as of the Effective Date is  attached as Exhibit 1.138 hereto and will be updated by Pieris as required from time to time  during the Term.    “Pieris Platform Technology” means (i) Anticalin Libraries, Anticalin Selection,  Anticalin Expression, Anticalin Characterization, and Anticalin Affinity Maturation, all to  the extent Controlled by Pieris or its Affiliates and (ii) all Know-How (and all Intellectual  Property Rights therein) used by or on behalf of Pieris in connection with the materials and  processes of subsection (i) of this definition.   “Pieris Product IP” means the Pieris Product Know-How and Pieris Product  Patents.   “Pieris Product Know-How” means all Pieris Know-How in relation to any  Product as of the Effective Date, excluding the Pieris Building Block Know-How, the  Pieris Platform Know-How and the Pieris Platform Improvement Know-How.   “Pieris Product Patent” means the Pieris Patents Covering any Product or uses  thereof as of the Effective Date excluding the Pieris Building Block Patents, the Pieris  Platform Patents and the Pieris Platform Improvement Patents. The Product Patents are  listed in Exhibit 1.142.    “Pieris US” has the meaning set forth in the preamble.   “Product” means a bispecific Antibody-Anticalin protein fusion Biologic  comprising the Antibody Building Block Targeting [***] set forth in Exhibit 1.144 and the  Anticalin Building Block Targeting [***] with the sequence set forth in Exhibit 1.144.).   “Product Cell Line License” means the Commercial License Agreement related to  the Product by and between [***] and [***] with an effective date of [***].   “Product Development Plan” means a plan setting out the roles and  responsibilities of each Party in connection with the Development and Manufacture of  

 

[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.]    Execution Version  Page 21 of 94      GDSVF&H\6023374.4  Product as set forth in this Agreement. The Product Development Plan shall also include a  budget outlining the costs associated with the Manufacturing tasks detailed in such Plan,  and may be updated by BP from time to time.    “Product Royalty” has the meaning set forth in Section 8.4.1.   “Prosecution and Maintenance” or “Prosecute and Maintain” means, with  regard to a particular Patent, the preparation, filing, prosecution and maintenance of such  Patent, as well as all proceedings that may take place before the patent office in any given  country or territory, including but not limited to U.S. interferences, U.S. inter partes  reviews and EP oppositions. For avoidance of doubt, “Prosecution and Maintenance” or  “Prosecute and Maintain” will not include any actions taken with respect to a Patent under  Section 9.6 or Section 9.7.   “Publishing Party” has the meaning set forth in Section 10.2.1.   “Receiving Party” has the meaning set forth in Section 10.1.1.   “Regulatory Authority” means any Governmental Authority involved in granting  approvals for Development, Manufacturing or Commercialization, including the FDA, the  EMA, the Japanese Ministry of Health, Labour and Welfare and the Pharmaceuticals and  Medical Devices Agency in Japan.   “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity  rights conferred by any applicable Governmental Authority or Regulatory Authority, other  than an issued and unexpired Patent, including any regulatory data protection exclusivity  (including, where applicable, pediatric exclusivity and/or orphan drug exclusivity) and/or  any other exclusivity afforded by restrictions which prevent the granting by a Regulatory  Authority of regulatory approval to market a Biosimilar.   “Regulatory Materials” means regulatory applications, submissions, dossiers,  notifications, registrations, case report forms, trial master file, drug master file (“DMF”),  common technical documents, question and answers with Regulatory Authorities,  Marketing Approvals or other filings or communications made to or with, or other  approvals granted by, a Regulatory Authority that are necessary or reasonably desirable in  order to Develop, Manufacture or Commercialize a Product in a particular country or  regulatory jurisdiction.    “Research” or “Researching” means activities, other than Development, related to  the design, discovery, generation, identification, profiling, characterization, production,  process development, cell line development, pre-clinical development or non-clinical or  pre-clinical studies of drug candidates and 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.]    Execution Version  Page 22 of 94      GDSVF&H\6023374.4   “Reviewing Party” has the meaning set forth in Section 10.2.1.   “[***]” has the meaning set forth in Section 2.4.1.   [***] with regards to a Product in any portion of the [***].   “[***]” means the [***].   “Royalty Term” means, on a Product-by-Product and country-by-country basis, the  time period from the First Commercial Sale of such Product in such country until the later  of (a) the last to expire of the Valid Claims Covering the Manufacture or  Commercialization (including the use, sale or offer for sale) of such Product in such  country and (b) [***] years from the First Commercial Sale of such Product in such  country.    “Rules” has the meaning set forth in Section 14.1.4.1.   “Sales Milestone Event” has the meaning set forth in Section 8.3.   “Sales Milestone Payments” has the meaning set forth in Section 8.3.    “Senior Executives” means the Chief Executive Officers of Pieris and BP.   “Senior Representatives” means a Vice President-level or above representative  with relevant decision-making authority with respect to an applicable Dispute under this  Agreement.   “SPCs” has the meaning set forth in Section 9.9.   “Sublicense” means an agreement between BP or its Affiliates or Sublicensees and  a further Sublicensee.     “Sublicense Consideration” means Consideration in connection with a Sublicense  (including an agreement that includes the right to have sold, such as in certain distributor  or co-promotion agreements). For avoidance of doubt, “Sublicense Income” shall not  include royalties based on [***] or (a) [***], (b) [***],  (c) [***], and (d) [***]. In the case  of Sublicense Income in the form of a premium paid solely by Sublicensee in exchange for  the issuance of equity in BP or any Affiliate over and above the then-current fair market  value of such equity, or Sublicense Income in the form of in-kind or non-monetary  consideration, the amount of the premium or the monetary value of the consideration will  be negotiated by the Parties in good faith.    “Sublicense Revenue Period” has the meaning set forth in Section 8.7.4.  

 

[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.]    Execution Version  Page 23 of 94      GDSVF&H\6023374.4   “Sublicense Revenue Share” has the meaning set forth in Section 8.7.4.   “Sublicensee” means a Third Party to whom BP or its Affiliates or Sublicensees  has, pursuant to Section 2.3.1, granted a sublicense under any rights granted under Section  2.1 to Exploit the Product.    “Target” means the biological target of a pharmacologically active drug  compound. “Target” and “Targeting” have a correlative meaning.    “Technology Transfer Plan” has the meaning set forth in Section 4.3.2.   “Term” has the meaning set forth in Section 13.1.   “Terminated Product” has the meaning set forth in Section 13.3.1.   “Territory” means all countries of the world.    “Third Party” means any Person other than BP, Pieris or their respective Affiliates.   “Third Party Claims” has the meaning set forth in Section 12.1.    “Third Party License Cost Split” has the meaning set forth in Section  8.6.2.   “Trademark” means any trademark, trade name, service mark, service name,  brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership,  including the goodwill and activities associated with each of the foregoing.   “[***]” has the meaning set forth in Section 12.2.   “[***] License Agreement” has the meaning set forth in Section 12.2.   “Valid Claim” means (a) a claim of an issued and unexpired Pieris Patent or Co- Invented Arising Patent, which claim has not been revoked or held invalid or unenforceable  by a court or other government agency of competent jurisdiction by a final determination  without the possibility of appeal or has not been held or admitted to be invalid or  unenforceable through re-examination or disclaimer, reissue, opposition procedure, nullity  suit or otherwise by a final determination without the possibility of appeal or (b) a claim  of a pending Pieris Patent or Co-Invented Arising Patent 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.  Notwithstanding the foregoing, [***].   2. LICENSE GRANTS  

 

[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.]    Execution Version  Page 24 of 94      GDSVF&H\6023374.4   Product. Subject to the terms and conditions set forth herein, Pieris hereby grants to  BP:   a non-exclusive, sublicensable (subject to Section 2.3.1), personal and non- transferable (except as set forth Section 14.3), right and license under the Pieris IP   (including the Platform IP, Pieris Platform Improvement IP and Pieris Building  Block IP but excluding the Pieris Product IP) to Exploit (subject to Section 4.5)  Products in the Territory solely for Commercialization of such Product in the Field  and in the Territory;   a royalty-bearing, sublicensable (subject to Section 2.3.1), non-transferable  (except as set forth in Section 14.3), exclusive (even as to Pieris, subject to Section  2.2) right and license under the Pieris Product IP to Exploit (subject to Section 4.5)  Products in the Territory solely for Commercialization of such Product in the Field.   Development and Manufacturing Assistance License. Subject to the terms and  conditions set forth herein, BP hereby grants to Pieris a non-exclusive license under the  Pieris Product IP to assist BP in connection with the Development and Manufacture of  Products for such time as Pieris’ supporting in Developing and Manufacturing the Product  as contemplated under this Agreement is concluded.   Sublicense and Subcontract Rights and Obligations.    BP Sublicensing and Subcontracting. BP shall have the right to sublicense  or subcontract (through multiple tiers), in whole or in part, the rights provided under  Section 2.1 above; provided, however: (a) such Sublicense or subcontractor  agreement will be consistent with all relevant terms and conditions of this  Agreement, (b) such Sublicense or subcontractor agreement shall not relieve BP of  its diligence obligations hereunder, (c) BP will remain liable for performance of all  the terms and conditions of this Agreement (including but not limited to payment  terms) such that any act or omission by or on behalf of a Sublicensee or  subcontractor that would be a breach of this Agreement if undertaken by BP, shall  be deemed a breach of this Agreement by BP; provided, however, BP shall have  the opportunity to cure such breach in accordance with Section 13.2.1, (d) such  subcontractors (including, e.g., consultants) and Sublicensees undertake in writing  obligations of confidentiality and non-use regarding Confidential Information that  are at least as restrictive as those undertaken by the Parties pursuant to Section 10  (except for a commercially-reasonable term for duration of confidentiality), (e) in  the case of a [***], BP shall comply with its [***] obligations to Pieris under  Section 2.4, and (f) BP shall notify Pieris within[***] Business Days of granting  such [***], providing [***] and a summary of [***].   Pieris Subcontracting. Pieris may not subcontract, delegate or sublicense  

 

[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.]    Execution Version  Page 25 of 94      GDSVF&H\6023374.4  the performance of its manufacturing assistance without BP’s prior written consent,  which may be withheld in BP’s sole discretion. Subject to BP’s prior written  consent, Pieris shall have the right to subcontract its manufacturing assistance;  provided, however, that Pieris will remain liable for performance of all the terms  and conditions of this Agreement applicable to Pieris such that any act or omission  by or on behalf of a subcontractor that would be a breach of this Agreement if  undertaken by Pieris, shall be deemed a breach of this Agreement by Pieris. For the  avoidance of doubt, Pieris may subcontract its manufacturing assistance to the  Persons set forth in Exhibit 2.3.2.   [***].    In the event that BP determines that it should [***], BP shall promptly  provide Pieris written notice prior to [***]. If within [***] days following receipt  of [***], Pieris notifies BP of [***].    In the event that BP [***], BP shall promptly provide [***]. If within [***]  days following receipt of the [***].   In the event Pieris: (a) does not [***] within [***] days following receipt of  the [***]; (b) the Parties [***] day period following Pieris’ written notice of such  interest; (c) indicates it [***], or (d) [***], then BP shall have no further obligation  to Pieris under this Section 2.4, [***].   For the avoidance of doubt (and subject to Section 2.4.3), BP [***] until it  has followed the procedure set forth in Section 2.4.1 or Section 2.4.2.   No Implied Rights. No license or other right is or shall be created or granted hereunder  by implication, estoppel or otherwise. All licenses and rights hereunder are or shall be  granted only as expressly provided in this Agreement. All rights a Party not expressly  granted hereunder are reserved by such Party and, except as otherwise expressly set forth  herein, may be used by such Party for any purpose.  3. GOVERNANCE, REPORTING & DECISION-MAKING   Alliance Manager. No later than [***] days after the Effective Date, each Party will  designate an individual to facilitate communication, Data exchange and coordination of the  Parties’ activities under this Agreement, including Exploitation of Products (each, an  “Alliance Manager”). The Alliance Managers shall meet quarterly or as otherwise agreed  in order to perform such responsibilities.   Decision Making. BP shall have the exclusive right, and sole responsibility and  decision-making authority (either itself or through its Affiliates, agents, subcontractors  

 

[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.]    Execution Version  Page 26 of 94      GDSVF&H\6023374.4  and/or Sublicensees) to Exploit the Products in the Field and in the Territory.  Notwithstanding the foregoing, Pieris shall have final decision-making authority with  respect to deployment of its internal resources and FTEs under the Product Development  Plan or otherwise, provided, however, that Pieris shall have the obligation to make  available the internal resources and FTEs as set forth in the Initial Product Development  Plan.   Annual Reporting. BP shall update Pieris as to the status of the Exploitation of  Products through a written annual report no later than [***] days following the end of [***]  and each Calendar Year thereafter, outlining BP’s efforts in connection with Exploitation  relating to each Product and informing Pieris of material events related to the Development  of the Product, including, to the extent not already provided, a copy of the clinical study  report (CSR) for each conducted Clinical Study. Such report shall also provide an updated,  rolling diligence plan summarizing the Exploitation activities anticipated to be undertaken  over [***] years immediately subsequent to the Calendar Year of such report. Such written  report shall be in sufficient detail so as to enable Pieris to monitor BP’s compliance with  its diligence obligations under Section 7.1, such as setting forth information related to  Clinical Studies (such as development phase, Indications, anticipated size and duration,  primary endpoints, and top-line results, as available and applicable) that (a) have been  conducted in the prior [***] months or (b) are intended to be conducted or Initiated in the  next [***] months; anticipated launch dates by country; in the event of [***] successive  Calendar Quarters of declining Net Sales of such Product, a high-level explanation of such  declining Net Sales.  Not more than [***] per Calendar Year, Pieris may reasonably request  a telephone conference to discuss the annual report provided under this Section 3.3 and  such telephone conference shall occur within [***] days of Pieris’ request.  4. DEVELOPMENT & MANUFACTURING   Initial Product Development Plan. The Parties have agreed on an initial Product  Development Plan (the “Initial Product Development Plan”), which is attached to this  Agreement as Exhibit 4.1.    Amendments to the Product Development Plan. Subject to the other provisions of  this Agreement, the Product Development Plan may be updated and amended from time to  time by BP.   Initial Know-How & Materials Transfer.    As soon as reasonably practicable and within [***] days following the  Effective Date or any other schedule agreed upon by the Parties, Pieris shall transfer  to BP, at Pieris’ cost and expense, all Know-How Controlled by Pieris and directly  related to the Exploitation of the Products as set forth in the Technology Transfer  Plan. As soon as reasonably practicable after the Effective Date and within the  

 

[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.]    Execution Version  Page 27 of 94      GDSVF&H\6023374.4  longest of (a) [***] days following the Effective Date, (b) [***] days following BP  providing information on where to transfer (including the address) in writing, or (c)  any other schedule agreed upon by the Parties, Pieris shall transfer all physical and  biological materials Controlled by Pieris and directly related to the Product (such  as the master cell bank associated with the Product) as set forth in the Technology  Transfer Plan (which will be updated to include a detailed description of each such  physical or biological material), subject to the Cell Line License and any quantities  of Products available; provided, in the event Pieris reasonably determines that  additional time is necessary properly to effectuate such transfer of physical and  biological materials, the Alliance Managers shall work together reasonably and in  good faith to ensure prompt, proper transfer of such physical and biological  materials.   Subject to Section 4.3.1, Pieris shall transfer all Know-How described in (and  transfer shall be conducted in accordance with) the technology transfer plan  attached hereto as Exhibit 4.3.2 (the “Technology Transfer Plan”) which: (a)  specifies goals and estimated timelines for the achievement of the transfer; (b)  specifies specific Know-How to be transferred; and (c) sets forth those obligations  assigned to each Party with respect to such Know-How transfer.     The Know-How and Material transfers set forth in this Section 4.3 shall occur  in an orderly fashion and in a manner such that the value, usefulness and  confidentiality of the transferred Know-How and biological or physical materials  are preserved by both Parties.   Ongoing Know-How Transfer. Following the initial transfer of Know-How and  materials under Section 4.3, Pieris shall provide, in the first [***] months following the  Effective Date, BP with reasonably requested non-Manufacturing related Pieris Know- How (such as protocols or Data) and reasonable access to Pieris personnel for questions or  clarification as are reasonably required in order for BP to Exploit the Product as  contemplated under this Agreement. For avoidance of doubt, any CMC and Manufacturing  related assistance shall be handled under Section 4.6.   Manufacturing Generally. For avoidance, of doubt, BP shall have sole control over  all aspects of the Manufacture of the Products in every country of the world.    Pieris Manufacturing Assistance.    Without limiting BP’s rights or Pieris’ obligations described in Section 4.3,  Section 4.4 or Section 4.5, and as reasonably requested or directed by BP, Pieris  shall provide up to [***] Dollars ($[***]) in FTE Costs and Out-of-Pocket Costs  connection with the Manufacture of Products. The anticipated contribution of Pieris  shall be included in the Product Development Plan, subject to Pieris’ consent with  

 

[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.]    Execution Version  Page 28 of 94      GDSVF&H\6023374.4  respect to proposed contribution of Pieris FTEs beyond what is set forth in the  Initial Product Development Plan.    The Parties anticipate Pieris will provide up to [***] FTE hours of support  during the first [***] months following the Effective date and up to [***] FTE  hours in total, in each case in connection with the Initial Product Development Plan.  Should activities requested of Pieris in connection with the Product Development  require Pieris to perform additional FTE hours, Pieris shall promptly notify the BP  Alliance Manager and provide a detailed accounting of the hours expended and  activities performed to date and a good faith estimation of the additional FTE hours  necessary to complete such requested activities. Upon written authorization of the  BP Alliance Manager’s election, such additional FTE hours will be approved.   At least [***] per month, or as otherwise mutually agreed, during the time  Pieris is performing Pieris Conducted Activities under Product Development Plan,  Pieris shall update BP with respect to (a) the activities performed under the Product  Development Plan since the previous update, including all results achieved, (b) the  expected activities between such update and the next update and the prioritization  thereof, (c) any issues or circumstances of which Pieris is aware that may prevent  or adversely affect in a material manner its future performance of activities under  the Product Development Plan, and (d) any reasonably foreseeable expenditures for  amounts expected to be incurred (to the extent material).   Within [***] days after the end of each Calendar Quarter, Pieris will provide  BP with an itemized accounting in a format agreed between the Parties of the FTE  Costs and Out-of-Pocket Costs actually incurred by Pieris in connection with  activities under the Product Development Plan during such Calendar Quarter (the  “Quarterly Manufacturing Assistance Report”). In addition, [***]. BP shall  provide evidence of such [***] to Pieris (which Pieris shall include in the Quarterly  Manufacturing Assistance Report) and [***] days after the end of each Calendar  Quarter in which Pieris received such evidence. Once Pieris has expended [***]  Dollars ($[***]) in Pieris’ FTE Costs and Out-of-Pocket Costs (whether incurred  by Pieris or BP) as evidenced by such Quarterly Manufacturing Assistance  Reports)), the Parties may mutually agree that Pieris continue to provide  Manufacturing assistance, subject to Pieris’ consent and [***].   Without limiting any of its other rights under Section 4.3 or this Section 4.6,  BP reserves the right to take over responsibility for any activities performed (or to  be performed) by Pieris under the Technology Transfer Plan (including  development of a new master cell bank or research cell bank [***] up to: (a) [***]  Dollars ($[***]) if [***], or (b) [***] Dollars ($[***]) if [***], in each case (a) or  (b), of the [***]. [***] for any other activities in this Section 4.6.5 are subject to  [***].   

 

[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.]    Execution Version  Page 29 of 94      GDSVF&H\6023374.4   Expedited Dispute Resolution for Pieris Conducted Activities. In the event BP  reasonably determines there is an issue with any Pieris Conducted Activities, promptly  upon BP’s request and in any event within [***] Business Days, Pieris agrees to negotiate  reasonably and in good faith in connection with any aspect of the Pieris Conducted  Activities. BP may escalate any matter which cannot be resolved in such negotiation to the  Senior Representatives within [***] Business Days of the start of such negotiation and to  the Senior Executives within [***] Business Days of the escalation to the Senior  Representatives (if such Senior Representatives do not resolve such matter in such [***]  Business Days).   Mutual Cooperation. The Parties will cooperate, and will cause their Affiliates and  their and their Affiliates’ respective employees, agents and contractors to cooperate, with  each other to effectuate the transfer of rights and materials under this Section 4, including  by promptly executing and recording assignments and other documents as requested by  each Party (including the [***]). This includes those items in Exhibit 4.3.2 which are  indicated to require BP’s written agreement prior to transfer.    Product Cell Line License.    Within [***] days of receipt of the up-front payment in Section 8.1, Pieris  shall assign the Product Cell Line License to BP as permitted under such License.    The Parties acknowledge that the Manufacture the Product (as it exists as of  the Effective Date) is subject to the Product Cell Line License.    Each Party shall comply with its obligations under the terms of the Product  Cell Line License (including in connection with the Exploitation of the Product)  and shall notify the other Party immediately if it becomes aware of any dispute  under such agreement. Each Party agrees to provide all reasonably requested  assistance and information to the other Party to assist such other Party in its  compliance with the Product Cell Line License.   5. REGULATORY   Ownership. As between Pieris and BP, BP will exclusively own, maintain and have  control over all INDs, MAAs and related regulatory documentation submitted to any  Regulatory Authority with respect to any Product Exploited under this Agreement.    Responsibility. For the avoidance of doubt, BP (either itself or through its Affiliates,  subcontractors and/or Sublicensees) will have sole control over (including the exclusive  right, sole responsibility and final decision-making authority for) all aspects of regulatory  matters relating to any Product, including (a) overseeing, monitoring and coordinating all  regulatory actions, communications and filings with, and submissions to, each Regulatory  

 

[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.]    Execution Version  Page 30 of 94      GDSVF&H\6023374.4  Authority; (b) interfacing, corresponding and meeting with each Regulatory Authority; (c)  seeking and maintaining all regulatory filings; (d) maintaining and submitting all records  required to be maintained or required to be submitted to any Regulatory Authority; and (e)  conducting all Clinical Studies and non-clinical studies BP believes appropriate.   Communications.    Material Communications.    BP Communications. Within [***] Business Days after receipt of  any Material Anticalin Communication from a Regulatory Authority with  respect to any Product (or [***] Business Days to the extent such Material  Anticalin Communication is related to a Clinical Study hold or potential  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 any Product), BP will provide Pieris, through its  Alliance Manager, with a brief written description of the principal issues  raised in such Material Anticalin Communication.    Pieris Communications. Within [***] Business Days after receipt  of any Material Product Communication from a Regulatory Authority with  respect to any product Controlled by Pieris (or [***] Business Days to the  extent such Material Product Communication is related to a Clinical Study  hold or potential 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 any Product), Pieris will provide BP,  through its Alliance Manager, with a brief written description of the  principal issues raised in such Material Product Communication.   Safety Exchange Agreement. To the extent necessary for either Party to  comply with Applicable Law or Regulatory Authority requirements, the Parties  may negotiate in good faith and enter into a safety data exchange agreement.     Recalls. BP shall have the sole right to determine whether and how to implement a  recall or other market withdrawal of any Product.  6. COMMERCIALIZATION   Commercialization. For the avoidance of doubt, BP shall be solely responsible for  and have sole control over all aspects of the Commercialization of each Product in every  country of the world, including planning and implementation, distribution, booking of  sales, pricing, reimbursement, and costs.   

 

[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.]    Execution Version  Page 31 of 94      GDSVF&H\6023374.4   Reporting. BP shall remain subject to the reporting requirements under Section 3.3  with respect to the Commercialization of the Product.  7. DILIGENCE & NON-COMPETE   Diligence Requirements. BP shall use Commercially Reasonable Efforts to Develop,  Manufacture and Commercialize at least [***] for at least [***] Indication in the Field for  each of the following geographies: (a) [***]; (b) [***]; (c) [***]; and (d) [***]. For the  avoidance of doubt, BP may satisfy its obligations under this Agreement (including this  Section 7.1) through the efforts of its Affiliates, subcontractors or Sublicensees.   Non-Compete   Generally. During the Term, to the maximum extent permitted by Applicable  Law, each Party and its Affiliates and Sublicensees covenants not to Exploit, itself  or with a Third Party, any Competing Product in the Field and in the Territory;  provided, notwithstanding anything to the contrary in this Agreement:    the restrictions in Section 7.2.1 will not apply to any BP Parent  Entity, provided that the Exploitation of a Competing Product occurs  without any access by the relevant BP Parent Entity to any Know-How or  Pieris Confidential Information in BP’s possession or control related to the  Product; provided further that no BP Restricted Entity or BP Restricted  Individual is employed, contracted or otherwise consulted by the relevant  BP Parent Entity in the Exploitation of the Competing Product in any way;  and provided further, that a “firewall” of reasonable safeguards is put in  place by BP between individuals with access to information related to the  Product, on the one hand, and the personnel responsible for the Exploitation  of such Competing Product, on the other hand, and the Development or  Commercialization of such Competing Product does not make use of or  incorporate any technology Covered by Pieris Patents; and   the restrictions placed on BP and its Affiliates in Section 7.2.1 will  not apply in the event of a Change of Control of BP or any of its Affiliates  where BP or the applicable Affiliate is acquired, provided that the  Exploitation of such Competing Product occurs without any access to any  Know-How or Pieris Confidential Information in BP’s possession or control  related to the Product; and provided further, that a “firewall” of reasonable  safeguards is put in place by BP between individuals with access to  information related to the Product, on the one hand, and the personnel  responsible for the Exploitation of such Competing Product, on the other  hand, and the Development or Commercialization of such Competing  Product does not make use of or incorporate any technology Covered by  

 

[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.]    Execution Version  Page 32 of 94      GDSVF&H\6023374.4  Pieris Patents.   Effect of Sublicense. Notwithstanding Section 7.2.1, to the extent that BP  enters into a Sublicense wherein BP plays no role whatsoever in the Development,  Manufacture, and Commercialization of a Product, then, in such case BP and its  Affiliates shall be permitted to Research, Develop, Manufacture or Commercialize  a Competing Product. For avoidance of doubt, such Sublicensee shall remain  subject to the non-compete set forth in Section 7.2.1 and BP shall remain obligated  and liable for any breach of such non-compete by such Sublicensee.  8. PAYMENTS   Up-Front License Fee. In partial consideration for the license and rights granted to  BP herein related to Products, BP will pay, or cause to be paid, to Pieris within[***] days  of the Effective Date a one-time payment of [***] Dollars ($[***]). Such payment will be  non-refundable, non-creditable and not subject to set-off.   Developmental Milestones.    In partial consideration for the license and rights granted to BP herein related  to Products, on a Product-by-Product basis, BP will make, or cause to be made,  milestone payments to Pieris (each, a “Developmental Milestone Payment”) upon  the first achievement of the development and regulatory milestone events set forth  in this Section 8.2 (each, a “Developmental Milestone Event”) with respect to  such Product. Such Developmental Milestone Payments shall be made within [***]  days after achievement of the corresponding Developmental Milestone Event.   

 

[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.]    Execution Version  Page 33 of 94      GDSVF&H\6023374.4  Developmental  Milestone Event [***] [***] [***]  Phase 1 Study  Initiation: [***] Dollars ($[***]) [***] [***]  Phase 1b Study  Initiation or Phase 2  Study Initiation:  [***] Dollars ($[***]) [***] [***]  Phase 3 Study  Initiation: [***] Dollars ($[***]) [***] Dollars  ($[***]) [***]  [***] [***] Dollars ($[***]) [***] Dollars  ($[***])  [***] Dollars  ($[***])  [***] [***] Dollars ($[***]) [***] Dollars  ($[***]) [***]  [***] [***] Dollars ($[***]) [***] Dollars  ($[***]) [***]  Total [***] Dollars ($[***]) [***] Dollars  ($[***])  [***] Dollars  ($[***])   For the avoidance of doubt: (a) the total maximum milestones payable under  this Section 8.2 for each Product, for the first Indication, shall not exceed [***]  Dollars ($[***]); (b) the total maximum milestones payable under this Section 8.2  for each Product, for the second Indication, shall not exceed [***] Dollars ($[***]);  (c) the total maximum milestones payable under this Section 8.2 for each Product,  for the third Indication, shall not exceed [***] Dollars ($[***]); and (d) the total  maximum milestones payable under this Section 8.2 for each Product, in the  aggregate for any and all Indications, shall not exceed [***] Dollars ($[***]). With  respect to each Developmental Milestone Event for each Product, the Development  Milestone Payments to be made under this Section 8.2 shall be due and payable  only once, regardless of whether Commercialized as single agent, Combination  Product or Product Bundle.   The [***] and the [***] milestones shall be deemed achieved upon [***].   For avoidance of doubt, single events may trigger multiple Developmental  Milestone Payments. For example, to the extent that a [***] is Initiated with respect  to a Product and such [***] is directed to two Indications, then both the [***] Dollar  ($[***]) and [***] Dollar ($[***]) Developmental Milestone Payments shall be due  in connection with such single [***] Initiation.   

 

[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.]    Execution Version  Page 34 of 94      GDSVF&H\6023374.4   If any of the above Developmental Milestone Events are skipped (i.e. a later  Developmental Milestone Payment is payable before an earlier Developmental  Milestone Payment), the skipped Developmental Milestone Event will be deemed  to have been achieved upon the earlier of achievement of the subsequent milestone  or upon Marketing Approval and the corresponding Developmental Milestone  Payment(s) shall then become due, as applicable. Notwithstanding the above, if a  Product receives Accelerated Approval in [***], based on a Phase 1b Study or  Phase 2 Study, and the applicable Regulatory Authority requires a confirmatory  Phase 3 Study to be Initiated after such approval, then the applicable [***], shall  be deemed achieved, but the Phase 3 Study Initiation Developmental Milestone  Event shall only be deemed achieved once such confirmatory Phase 3 Study is  Initiated.    Sales Milestone Payments.    In partial consideration for the license and rights granted to BP herein related  to Products, BP shall make, or cause to be made, on a Product-by-Product basis,  the non-refundable, non-creditable, one-time payments (the “Sales Milestone  Payments”) to Pieris based upon the first achievement of the following Calendar  Year cumulative Net Sales of each Product (the “Sales Milestone Event”) as set  forth below within [***] days of the end of the Calendar Year in which a Sales  Milestone Event is achieved.  Sales Milestone Event Sales Milestone Payment  The first time Net Sales achieves [***] Dollars  ($[***]) in Net Sales of such Product in a  Calendar Year  [***] Dollars ($[***])    The first time Net Sales achieves [***] Dollars  ($[***]) in Net Sales of such Product in a  Calendar Year  [***] Dollars ($[***])    The first time Net Sales achieves [***] Dollars  ($[***]) in Net Sales of such Product in a  Calendar Year  [***] Dollars ($[***])    The first time Net Sales achieves [***] Dollars  ($[***]) in Net Sales of such Product in a  Calendar Year  [***] Dollars ($[***])    The first time Net Sales achieves [***] Dollars  ($[***]) in Net Sales of such Product in a  Calendar Year  [***] Dollars ($[***])     For the avoidance of doubt, each aforementioned Sales Milestone Payment  shall be made only once for each Product, regardless of the number of Products  

 

[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.]    Execution Version  Page 35 of 94      GDSVF&H\6023374.4  achieving the Sales Milestone Event, or the number of Calendar Years in which a  Product achieves such Sales Milestone Event.   The achievement of a higher Sales Milestone Event shall in addition trigger  the payment of a lower Sales Milestone Event in the event such lower Sales  Milestone Event had not been triggered prior to achievement of the higher Sales  Milestone Event. For example, if in the first Calendar Year following the [***] Sale  of a Product, cumulative Net Sales of such Product in such Calendar Year are [***]  Dollars ($[***]), the Sales Milestone Event for cumulative Net Sales achieving  [***] Dollars ($[***]), [***] Dollars ($[***]) and [***] Dollars ($[***]) in Net  Sales for such Product in a Calendar Year will be triggered and, upon receipt of  notice from BP of achievement of such Sales Milestone Events, Pieris shall invoice  BP for the corresponding [***] Dollar ($[***]), [***] Dollar ($[***]) and [***]  Dollar ($[***]) Sales Milestone Payments.   For the avoidance of doubt, the total maximum milestones payable for each  Product under this Section 8.3 shall not exceed [***] Dollars ($[***]).   Royalty Payments.    In partial consideration for the license and rights granted to BP herein related  to Products, BP shall make, or cause to be made, to Pieris, on a Product-by-Product  basis during the Royalty Term for each such Product, payments of royalties equal  to the following percentages of Net Sales (“Product Royalty”) of such Product  over a Calendar Year in the Territory.   Annual Calendar Year Royalty  Bearing Net Sales Royalty Rates owed by BP  Portion of Net Sales less than  [***] Dollars ($[***])  [***] Percent ([***]%)  Portion of Net Sales equal to or  greater than [***] Dollars ($[***])  and [***] Dollars ($[***])  [***] Percent ([***]%)  Portion of Net Sales equal to or  greater than [***] Dollars ($[***])  and less than [***] Dollars  ($[***])  [***] Percent ([***]%)  Portion of Net Sales equal to or  greater than [***] Dollars ($[***])  and less than [***] Dollars  [***] Percent ([***]%)  

 

[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.]    Execution Version  Page 36 of 94      GDSVF&H\6023374.4  ($[***])  Portion of Net Sales equal to or  greater than [***] Dollars ($[***])  [***] Percent ([***]%)   By way of illustration, assume in a Calendar Year, during the Royalty Term,  that (a) aggregate annual Net Sales of a Product in Dollars total [***] Dollars  ($[***]) and (b) no adjustments or deductions to payments under this Section 8  apply. The total Product Royalty due and payable by BP to Pieris for such Net Sales  would be, [***] Dollars ($[***]) calculated as follows:  $[***] x [***]% = $[***]   $[***] x [***]% = $[***]   $[***] x [***]% = $[***]    $[***] x [***]% = $[***]  Total Royalty = $[***]   For purposes of determining whether a royalty tier or a Sales Milestone Event  described in Section 8.3 or Section 8.4 above has been attained, only Net Sales that  are subject to a Product Royalty payment shall be included in the total amount of  Net Sales and any Net Sales that are not subject to a Product Royalty payment shall  be excluded.    Product Royalties payable under this Section 8.4 shall be payable on actual  Net Sales and shall accrue at the time the invoice for the sale of Product is delivered.  Product Royalty obligations that have accrued during a particular Calendar Quarter  shall be paid, on a Calendar Quarter basis, within [***] days after the end of each  Calendar Quarter during which the Product Royalty obligation accrued.   Other Payments.   As between the Parties, BP shall be solely responsible for and, except for the  one-time payment set forth in Exhibit 4.1, shall make all payments due in  connection with the Product Cell Line License without offset or reduction to the  payments due to Pieris under this Section 8.   The Parties acknowledge that Pieris is a Party to the [***] License  Agreement in connection with the license of certain Pieris Platform IP. Pieris shall  remain solely responsible for all payments due under the [***] License 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.]    Execution Version  Page 37 of 94      GDSVF&H\6023374.4   Other than the Product Cell Line License and the [***] License Agreement,  as of the Effective Date, there are no other Known Third-Party Obligations.    Additional Royalty Terms.   Royalty Term. The Product Royalties due under Section 8.4 shall be paid on  a country-by-country basis and shall be payable for the duration of the Royalty  Term.   Reductions for Third Party Obligations. Except as set forth in Section 8.5, in  the event BP or an Affiliate or Sublicensee reasonably determines it would be  necessary to obtain licenses to (or otherwise acquire) Patents of Third Parties other  than the Known Third-Party Obligations that Cover the active pharmaceutical  ingredient (“API”) of the initial Product as set forth in Exhibit 8.6.2, in order to  Manufacture after First Commercial Sale or Commercialize the API of such  Product (but not, for example, any formulation or associated device, which shall  solely be the responsibility of BP) (“Additional Third Party Licenses”), BP or  such relevant Affiliate or Sublicensee may negotiate and obtain any such Additional  Third Party Licenses but shall not be obligated to do so. Pieris and BP (or such  relevant Affiliate or Sublicensee, as applicable) shall share equally the costs under  such Additional Third Party Licenses (“Third Party License Cost Split”) and  Pieris’ [***] percent ([***]%) share of the royalties and sales milestones associated  with such Additional Third Party Licenses shall be payable in the form of a  reduction of the Product Royalty and Sales Milestone Payments that would  otherwise be payable by BP to Pieris. Pieris’ share of the total costs of such  Additional Third Party License shall not reduce Pieris’ Royalty or Sales Milestone  Payments by more than [***] percent ([***]%) of the Product Royalty or Sales  Milestone Payments otherwise due to Pieris in any Calendar Quarter, provided that  reductions to Royalty Payments or Sales Milestone Payments under this Section  8.6.2 not exhausted in one Calendar Quarter may be carried forward to the next  Calendar Quarter. Notwithstanding the foregoing, as an incentive to initiate a First  Commercial Sale prior to [***] (the “Early Launch Date”), the Third Party Cost  Split shall be modified so that Pieris covers [***] percent ([***]%) and BP (or such  relevant Affiliate or Sublicensee, as applicable) covers twenty-five percent  ([***]%) of the costs associated with any Additional Third Party License  attributable to the Commercialization of the Product through the Early Launch Date  (as determined in accordance with Accounting Standards). All other terms under  this Section 8.6.2 shall otherwise remain the same (including that Pieris’ [***]  percent ([***]%) share shall be payable in the form of a reduction of the Product  Royalty and Sales Milestone Payments that would otherwise be payable by BP to  Pieris, subject to a ([***]%) minimum payment of such Product Royalty and Sales  Milestone Payments and subject to the ability to carry forward any unexhausted  reductions to future Product Royalty and Sales Milestone Payments). For avoidance  

 

[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.]    Execution Version  Page 38 of 94      GDSVF&H\6023374.4  of doubt, nothing stated herein shall prevent Pieris from seeking licenses to any  Intellectual Property Rights from any Third Party as it deems necessary; provided  that to the extent that such Intellectual Property Rights constitute Pieris IP, such  Intellectual Property Rights are included in the licenses granted under Section 2 of  this Agreement.   Reduction for Loss of Exclusivity. On a Product-by-Product and country-by- country basis, in the event that (a) there is no Valid Claim Covering the  Manufacture or Commercialization (including the use, sale or offer for sale) of such  Product in such country, and (b) there is entry of a Biosimilar of such Product in  such country, then the Royalty Payment payable to Pieris for such Product in such  country shall be reduced by [***] percent ([***]%) of the amount otherwise  payable hereunder as and from such Calendar Quarter. For avoidance of doubt, if  there is a reduction of the Product Royalty in a country under this Section 8.6.3,  there shall be no further reduction of the Product Royalty in such country due to  Biosimilar competition under Section 8.6.4.    Reduction for Biosimilar Competition. If in any Calendar Quarter after entry  of a Biosimilar(s) of a Product in a given country there has been a decline of the  Net Sales of the applicable Product in such country of more than [***] percent  ([***]%) of the Net Sales of such Product in such country achieved in the  [***]consecutive Calendar Quarters immediately prior to such entry in such  country, the Royalty Payment payable to Pieris for such Product in such country  shall be reduced by[***] percent ([***]%) of the amount otherwise payable  hereunder as and from such Calendar Quarter. If in any Calendar Quarter after entry  of a Biosimilar(s) of a Product in a given country there has been a decline of the  Net Sales of the applicable Product in such country of more than [***] percent  ([***]%) of the Net Sales of such Product in such country achieved in the [***]  consecutive Calendar Quarters immediately prior to such entry in such country, the  Royalty Payment payable to Pieris for such Product in such country shall be  reduced by [***] percent ([***]%) of the amount otherwise payable hereunder as  and from such Calendar Quarter. Notwithstanding the foregoing, in the event of  Biosimilar sales that are later enjoined by a court or otherwise halted (such as on  the basis of Patent or Regulatory Exclusivity) and the price of the Product returns  to the same level as was achieved immediately prior to entry of the Biosimilar, then  royalties shall be restored to the level otherwise contemplated under this  Agreement.   In the event Pieris acquires Pieris IP from a Third Party after the Effective  Date and the use of such Pieris IP by BP would cause Pieris to owe payments to  such Third Party which would not otherwise be due but for BP’s use: (a) Pieris shall  promptly notify BP in writing of such Pieris IP and such payments (and payment  terms related thereto), and (b) in the event BP elects to use such Pieris IP, BP 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.]    Execution Version  Page 39 of 94      GDSVF&H\6023374.4  make, or cause to be made, payments to Pieris equal to: (i) for such IP that is  reasonably necessary for the Exploitation of the initial Product as set forth in  Exhibit 8.6.2, [***] percent ([***]%) of the payments set forth in such notice in  accordance with the payment terms set forth in such notice; (ii) for such IP that is  reasonably useful (but not reasonably necessary) for the Exploitation of any  Product, [***] percent ([***]%) of the payments set forth in such notice in  accordance with the payment terms set forth in such notice; or (iii) for such IP that  is reasonably necessary for the Exploitation of all Anticalin proteins (i.e., Anticalin  proteins generally), no amount shall be due from BP.    Revenue Sharing.    Change of Control Within [***] Months of Clinical PoC. In the event that  BP undergoes a Change of Control at any time from the Effective Date until [***]  months following Clinical PoC, BP shall pay Pieris [***] percent ([***]%) of all  COC Consideration due within [***] months of such Change of Control (such  period of time the “Change of Control Revenue Period” and such sum of money  the “Change of Control Revenue Share”).   Change of Control Thereafter. To the extent that BP undergoes a Change of  Control after [***] months following Clinical PoC, then Section 8.7.1 shall apply  except that the Change of Control Revenue Share that Pieris receives shall be  limited to COC Consideration received by Boston Pharma.   Equity Financing. In the event of an Equity Financing that would have been  a Change of Control but for the definition of Equity Financing, BP shall pay Pieris  [***] percent ([***]%) of all cash proceeds actually received by Boston Pharma in  connection with such Equity Financing (“Equity Financing Consideration”)  (such sum of money the “Equity Financing Revenue Share”).    In the event that BP Sublicenses its right to a Product, BP shall pay Pieris  [***] percent ([***]%) of all Sublicense Consideration due to BP from Sublicensee  within [***] months of the Sublicense Effective Date (such period of time the  “Sublicense Revenue Period” and such sum of money the “Sublicense Revenue  Share”).   For avoidance of doubt, the Sublicense Revenue Share shall not  relieve BP of its obligation to pay the Developmental Milestone Payments,  Sales Milestone Payments, and Product Royalties as set forth in this Section  8.    In the case of a Sublicense, to the extent that Sublicense  Consideration received by BP from a Sublicensee is made in connection  

 

[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.]    Execution Version  Page 40 of 94      GDSVF&H\6023374.4  with a development or regulatory milestone event that coincides with a  Developmental Milestone Event triggering a Developmental Milestone  Payment or Sales Milestone Event triggering a Sales Milestone Payment  (“Coinciding Milestone Payment”), then the corresponding Sublicense  Revenue Share payment shall be calculated based on the amount of the  Coinciding Milestone Payment minus the amount of the corresponding  Developmental Milestone Payment or Sales Milestone Payment. For  example, if BP receives a milestone payment from Sublicensee in  connection with BLA Approval in the US in the amount of [***] Dollars  ($[***]) (the Coinciding Milestone Payment) during the Sublicense  Revenue Period, then the corresponding Developmental Milestone Payment  of [***] Dollars ($[***]) to be paid to Pieris under Section 8.2 shall first be  subtracted from such amount, yielding [***] Dollars ($[***]) as the basis  for the calculation of the Sublicense Revenue Share and a corresponding  Sublicense Revenue Share of [***] Dollars ($[***]). For avoidance of  doubt, nothing in this Section 8.7.4.2 reduces or alters any Developmental  Milestone Payment or Sales Milestone Payment that BP is required to make  under this Agreement.    BP shall make Sublicense Revenue Share, Change of Control Revenue Share  and Equity Financing Revenue Share payments on an ongoing basis, providing such  payments within [***] days of receipt of the Sublicense Consideration, Change of  Control Consideration or Equity Financing Consideration from the Sublicensee or  acquiror, as applicable.    BP shall not enter into any Sublicense, Change of Control or Equity  Financing with any Third Party or BP Parent Entity which transaction is structured  in a way that is designed to deprive Pieris of the benefit of the Revenue Share  payable under this Section 8.7. In the event Pieris reasonably determines that a  Sublicense, Change of Control or Equity Financing was structured in way that was  designed to deprive Pieris of the benefit of the Revenue Share payable under this  Section 8.7, the Parties shall cooperate reasonably and in good faith to determine  whether such Sublicense, Change of Control or Equity Financing was not structured  in way that was designed to deprive Pieris of the benefit of the Revenue Share  payable under this Section 8.7 and, if, after such cooperation, Pieris again  reasonably determines that such Sublicense, Change of Control or Equity Financing  was structured in way that was designed to deprive Pieris of the benefit of the  Revenue Share payable under this Section 8.7, to the Parties shall negotiate in good  faith the Revenue Share (if any) which would have been payable under this Section  8.7 if such Sublicense, Change of Control or Equity Financing was not structured  in way that was designed to deprive Pieris of the benefit of the Revenue Share  payable under this Section 8.7.   

 

[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.]    Execution Version  Page 41 of 94      GDSVF&H\6023374.4   For the avoidance of doubt, there shall be no multiple counting with respect  to COC Consideration, Sublicense Consideration and Equity Financing  Consideration and COC Consideration, Sublicense Consideration and Equity  Financing Consideration shall each exclude any Consideration already accounted  for in another class of Consideration.    If any (a) Sublicense includes any sublicense in which BP or any of its  Affiliates conveys rights to Exploit one or more products other than the Product,  (b) Change of Control of BP conveys rights to Exploit one or more products other  than the Product, or (c) Equity Financing that would have been a Change of Control  but for the definition of Equity Financing and includes Equity Financing  Consideration and contemplates rights to Exploit one or more products other than  the Product (the rights to Exploit such products other than the Product in clauses  (a), (b) and (c) collectively, the “Other Assets”), then the Sublicense  Consideration, COC Consideration or Equity Financing Consideration (as the case  may be) will be adjusted to include only the relative value attributed at such time  to the Product and to exclude the relative value attributed at such time to the Other  Assets. Such relative value and related adjustment will be negotiated by the Parties  in good faith.    Payment Terms.   Manner of Payment. All payments to be made by BP hereunder will be made  in Dollars by wire transfer to such bank account as Pieris may designate.   Reports and Royalty Payments. For each Calendar Quarter during which  Product has been sold and as long as a Product Royalty is due to Pieris under this  Agreement, BP will furnish to Pieris (a) a good faith estimate, within [***] days  after the end of each such Calendar Quarter, and (b) a written report, within [***]  days after the end of each such Calendar Quarter, both (a) and (b) showing the  amount of Net Sales of Product and royalty due (in Dollars). The report will  include, at a minimum, the following information for the applicable Calendar  Quarter, each listed by country of sale: (i) the number of units of each Product on  which Product Royalty owed to Pieris hereunder sold by BP or its Affiliates or  Sublicensees; (ii) the gross amount received for such sales; (iii) Net Sales for the  Calendar Quarter and Year; (iv) deductions provided for in the definition of Net  Sales; and (v) the Product Royalties owed to Pieris. Such reports shall be deemed  Confidential Information of BP subject to Section 10 of this Agreement.   Records and Audits.    BP shall keep complete, true and accurate books and records in  accordance with its Accounting Standards in relation 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.]    Execution Version  Page 42 of 94      GDSVF&H\6023374.4  including in relation to the Product and Net Sales. BP will keep such books  and records for at least [***] years following the Calendar Year to which  they pertain.    Pieris may, not more than [***] per Calendar Year, upon written  request, cause an internationally-recognized independent accounting firm  (the “Auditor”), which is reasonably acceptable to BP, to inspect the  relevant records of BP and its Affiliates to verify the payments made or  Costs incurred by BP and the related reports, statements and books of  accounts, as applicable. Before beginning its audit, the Auditor shall  execute an undertaking reasonably acceptable to BP by which the Auditor  agrees to keep confidential all information reviewed during the audit. The  Auditor shall have the right to disclose to Pieris a non-confidential summary  of the basis for its conclusions and its conclusions regarding any payments  owed under this Agreement (including, for the avoidance of doubt, the  magnitude of any overpayment or underpayment) and to discuss with the  Parties how to interpret this Agreement.   BP and its Affiliates shall make their records available for  inspection by the Auditor (and not, for the avoidance of doubt, Pieris or any  other representative of Pieris) during regular business hours at mutually  agreed time(s) and place(s), upon receipt of reasonable advance notice from  Pieris or the Auditor. Such inspection right shall not be exercised more than  [***] in any Calendar Year and not more frequently than once with respect  to records covering any specific period of time. In addition, Pieris shall only  be entitled to audit the books and records of BP from the [***] Calendar  Years prior to the Calendar Year in which the audit request is made;  provided, for the avoidance of doubt, neither BP nor any Affiliate shall be  required to retain records beyond the period set forth in Section 8.8.3.1. The  Auditor shall provide its audit report and basis for any determination to BP  at the time such report is provided to Pieris before it is considered final. In  the event that the final result of the inspection reveals an undisputed  underpayment or overpayment by either Party, the underpaid or overpaid  amount shall be settled promptly. Pieris shall pay for such inspections, as  well as its expenses associated with enforcing its rights with respect to any  payments hereunder.   If an underpayment of more than the greater of (a) [***] percent  ([***]%) of the total payments due hereunder for the applicable Calendar  Year and (b) [***] Dollars ($[***]) is discovered, the fees and expenses  charged by the Auditor shall be paid by BP.   The terms of this Section 8.8.3 shall apply mutatis mutandis with  

 

[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.]    Execution Version  Page 43 of 94      GDSVF&H\6023374.4  respect to BP’s right to audit Pieris’ records related to any amounts for  which Pieris seeks reimbursement or deduction from the pledged  Manufacturing assistance.    Currency Exchange. The amounts due to Pieris under this Agreement will be  expressed in Dollars. When conversion of payments from any foreign currency is  required to be undertaken by BP, the Dollar equivalent shall be calculated using  BP’s, its Affiliate’s or Sublicensee’s standard conversion methodology consistent  with relevant GAAP.    Taxes.   The royalties, milestones, sublicense revenue share and other  amounts payable by BP to Pieris pursuant to this Agreement (“Payments”)  shall not be reduced on account of taxes unless required by Applicable Law.  Pieris alone shall be responsible for paying any and all taxes (other than  withholding taxes required by Applicable Law to be paid by BP) levied on  account of, or measured in whole or in part by reference to, any Payments  it receives. BP shall deduct or withhold from the Payments any taxes that it  is required by Applicable Law to deduct or withhold. If, however, Pieris is  entitled under any applicable tax treaty to a reduction of rate of, or the  elimination of, applicable withholding tax, it may deliver to BP or the  appropriate Governmental Authority (with the assistance of BP to the extent  that this is reasonably required and is expressly requested in writing) the  prescribed forms necessary to reduce the applicable rate of withholding or  to relieve BP of its obligation to withhold tax, and BP shall apply the  reduced rate of withholding, or dispense with withholding, as the case may  be, provided that BP has received evidence, in a form reasonably  satisfactory to BP, of Pieris' delivery of all applicable forms at least [***]  Business Days prior to the time that the Payments are due. If BP withholds  any taxes from the Payments while Pieris is entitled under any applicable  tax treaty to a reduction of the rate of, or the elimination of, applicable  withholding tax, BP shall cooperate with Pieris with respect to any  documentation required by the appropriate Governmental Authority or  reasonably requested by Pieris to secure a reduction of the rate of, or the  elimination of, the applicable taxes withheld.   Notwithstanding anything to the contrary contained in this  Agreement, the following shall apply with respect to Indirect Taxes: All  payments are stated exclusive of Indirect Taxes. If any Indirect Taxes are  chargeable in respect of any payments, BP shall pay such Indirect Taxes at  the applicable rate in respect of any such payments following the receipt,  where applicable, of an Indirect Taxes invoice issued in the appropriate  

 

[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.]    Execution Version  Page 44 of 94      GDSVF&H\6023374.4  form by Pieris in respect of those payments, such Indirect Taxes to be  payable on the due date of the payment of the payments to which such  Indirect Taxes relate or at the time such Indirect Taxes are required to be  collected by Pieris, in the case of payment of Indirect Taxes to Pieris. The  Parties shall issue invoices for all goods and services supplied under this  Agreement consistent with Indirect Tax requirements, and to the extent any  invoice is not initially issued in an appropriate form, each Party shall  promptly inform the other Party and shall cooperate with such other Party  to provide such information or assistance as may be necessary to enable the  issuance of such invoice consistent with Indirect Tax requirements.   Interest Due. BP will pay Pieris interest on any undisputed payments that are  not paid on or before the date such payments are due under this Agreement at a rate  of [***] percent ([***]%) above SOFR per annum or the maximum applicable legal  rate, if less, calculated on the total number of days such payment is delinquent.  9. INTELLECTUAL PROPERTY   Ownership of Background IP. Unless otherwise explicitly stated in this Agreement,  as between the Parties, all Know-How and Intellectual Property Rights Controlled by a  Party prior to the Effective Date or developed separate and apart from this Agreement, shall  be deemed owned by the Party Controlling such Know-How or Intellectual Property  Rights.   Ownership and Right to Exploit.    Ownership.   Pieris Platform Improvement IP. Pieris Platform Improvement IP  shall be solely owned by Pieris.  BP, for itself and on behalf of its Affiliates,  hereby assigns (and to the extent such assignment can only be made in the  future hereby agrees to assign), to Pieris all its right, title and interest in and  to any Pieris Platform Improvement IP.  BP will cooperate, and will cause  its and its Affiliates’ respective employees, agents and contractors to  cooperate, with Pieris to effectuate and perfect the foregoing ownership,  including by promptly executing and recording assignments and other  documents consistent with such ownership.    Pieris Building Block IP. Pieris Building Block IP shall be solely  owned by Pieris.  BP, for itself and on behalf of its Affiliates, hereby assigns  (and to the extent such assignment can only be made in the future hereby  agrees to assign), to Pieris all its right, title and interest in and to any Pieris  Building Block IP.  BP will cooperate, and will cause its and its Affiliates’  

 

[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.]    Execution Version  Page 45 of 94      GDSVF&H\6023374.4  respective employees, agents and contractors to cooperate, with Pieris to  effectuate and perfect the foregoing ownership, including by promptly  executing and recording assignments and other documents consistent with  such ownership.    Pieris Product IP. Pieris Product IP shall be solely owned by Pieris.    Arising IP. BP shall own all Arising IP.  Pieris, for itself and on  behalf of its Affiliates, shall assign and hereby assigns to BP all right, title  and interest in the Arising IP. Pieris will cooperate, and will cause its and  its Affiliates’ respective employees, agents and contractors to cooperate,  with BP to effectuate and perfect the foregoing ownership, including by  promptly executing and recording assignments and other documents  consistent with such ownership.   Right to Exploit. For all Patents within the Pieris IP (including the  Pieris Product IP), BP hereby covenants not to practice such Patents outside  the scope of the licenses granted to BP under Section 2 of this Agreement.  For avoidance of doubt, this includes the Manufacture, use, sale or offer for  sale of any Biologic other than the Product licensed under Section 2 of this  Agreement. Pieris shall retain the exclusive right to practice (including the  grant of (sub)licenses) all Patents within the Pieris IP (including the Product  IP) outside the scope of such licenses, subject to the non-compete provisions  of Section 7.2.   Prosecution and Maintenance.    IP Coordination. Representatives of the Parties shall meet together from time  to time as reasonably requested by either Party to discuss the Prosecution and  Maintenance of all Patents within the Pieris Product IP and Arising IP.  In addition  to the notification rights listed below, with respect to such Patents, the Parties shall  discuss with each other the overall strategy for Prosecution and Maintenance of  such Patents in advance (for example, scope of claims to be pursued, countries for  national entry, etc.). Each Party shall consider in good faith the other Party’s  suggestions and comments regarding such Prosecution and Maintenance strategy.    Key IP.   General.  Subject to the remainder of this Section 9.3.2.1, as  between the Parties, BP will have the first right (but not the obligation), at  BP’s sole discretion, and sole responsibility for all applicable costs, to  Prosecute and Maintain all Patents within the Pieris Product IP and Co- Invented Arising IP (“Key IP”); provided that, BP shall share with Pieris 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.]    Execution Version  Page 46 of 94      GDSVF&H\6023374.4  draft of initial provisional or non-provisional patent applications (i.e. any  priority application or PCT application) within the Key IP and Arising IP  prior to filing and consider Pieris’ comments in good faith.  BP shall  otherwise have final decision-making authority with respect to such  applications. Pieris Know-How and Pieris Confidential Information shall  not be incorporated into such applications without Pieris’ prior written  consent. BP shall not pursue a Patent claim within the Key IP that is not  limited to the applicable Target or that seeks protection for a Building Block  alone (as such claim would render the Patent a Pieris Building Block  Patent). BP will consult with Pieris on its strategy for the Prosecution and  Maintenance of all such Patents within the Key IP.  BP will furnish Pieris,  via electronic mail or such other method as mutually agreed by the Parties,  copies of substantive proposed filings and documents received from outside  counsel in the course of Prosecuting and Maintaining such Patents within  the Key IP, or copies of documents filed with the relevant patent offices or  other Governmental Authorities with respect to such Patents within the Key  IP, and such other substantive documents related to the Prosecution and  Maintenance of such Patents within the Key IP, and as applicable in  sufficient time prior to filing such document or making any payment due  thereunder to allow for review and comment by Pieris and will consider in  good faith timely comments from Pieris thereon.  BP will furnish Pieris, via  electronic mail or such other method as mutually agreed by the Parties,  copies of documents filed with the relevant national patent offices or other  Governmental Authorities with respect to such Patents within the Key IP.  Each Party will sign, or will use best efforts to have signed, all legal  documents as are reasonably necessary to Prosecute and Maintain Patents  within the Key IP.    Dropped Key IP. In the event that BP elects not to Prosecute and  Maintain (or continue to Prosecute and Maintain, including filing a Patent  claiming priority to a Patent prior to its issuance), any Patent within the Key  IP anywhere in the world, BP will notify Pieris at [***] days before any  such Patent would become abandoned, no longer available or otherwise  forfeited, and Pieris will have the right (but not the obligation), at Pieris’  sole discretion to Prosecute and Maintain such Patent worldwide in the  name of Pieris at Pieris’ sole cost (which right will include the right to file  additional Patents claiming priority to such Patent). For the avoidance of  doubt, any Pieris Product Patent or Co-Invented Arising Patent which Pieris  Prosecutes and Maintains under this Section 9.3.2.2 shall remain licensed  to BP under Section 2.1.2.   Arising IP.  As between the Parties, BP will have the right (but not the  

 

[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.]    Execution Version  Page 47 of 94      GDSVF&H\6023374.4  obligation), at BP’s sole discretion, to Prosecute and Maintain all Patents within the  Arising IP (other than Co-Invented Arising IP, which is addressed above in Section  9.3.2) in BP’s name.  BP shall Prosecute and Maintain such Arising IP at its sole  discretion and expense but will discuss in good faith the strategy for Prosecution  and Maintenance of such Arising IP upon Pieris’ request.   Other Pieris IP (Pieris Building Block IP, Pieris Platform IP, and Pieris  Platform Improvement IP). As between the Parties, Pieris will have the right (but  not the obligation), at Pieris’ sole discretion, to Prosecute and Maintain all Patents  within the Pieris Building Block IP, Pieris Platform IP, and Pieris Platform  Improvement IP (“Other Pieris IP”), in Pieris’ name.  BP acknowledges that the  Other Pieris IP Covers or potentially Covers a number of therapeutic programs  outside of this Agreement and has been licensed to Third Parties and may be  licensed to additional Third Parties in the future. Accordingly, Pieris shall Prosecute  and Maintain the Other Pieris IP at its sole discretion and expense but will discuss  in good faith the strategy for Prosecution and Maintenance of the Other Pieris IP  upon BP’s request. Each Party will sign, or will use best efforts to have signed, all  legal documents as are reasonably necessary to Prosecute and Maintain Patents  within the Other Pieris IP.   Patent Miscellaneous. Each Party hereby agrees: (a) to use Commercially  Reasonable Efforts to make its employees, agents and consultants reasonably  available to the other Party (or to the other Party’s authorized attorneys, agents or  representatives), to the extent reasonably necessary to enable such Party to  undertake any Prosecution and Maintenance described herein; and (b) to reasonably  cooperate in any such Prosecution and Maintenance by the other Party.   German Act on Employee Inventions. Where applicable, Pieris will be  responsible for remuneration of inventors who are Pieris employees in accordance  with the German Act on Employee Inventions with respect to the Pieris IP. BP will  provide all reasonably requested information and assistance in order for Pieris to  comply with the German Act on Employee Inventions with respect to such Patents.   BP Patents. For the avoidance of doubt: (a) BP shall have the exclusive right,  but not the obligation, to Prosecute and Maintain any Patents not addressed in this  Section 9 that are Controlled by BP (each, a “BP Patent”), and (b) BP shall have  the exclusive right, but not the obligation, to enforce or defend any Intellectual  Property Rights Controlled by BP (including Arising IP but excluding Co-Invented  Arising Patents), and, in each case (a) and (b), Pieris shall have no particular rights  with respect thereto.  

 

[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.]    Execution Version  Page 48 of 94      GDSVF&H\6023374.4   No Adverse Action.    BP shall not take any action in the Prosecution and Maintenance of the Key  IP and Arising IP pursuant to this Agreement that would have a material adverse  impact on any Patents within the Pieris Building Block IP, the Pieris Platform IP,  or the Pieris Platform Improvement IP.    Pieris shall not take any action in the Prosecution and Maintenance of the  Key IP pursuant to this Agreement that would have a material adverse impact on  any Patents within the Pieris Product IP.   CREATE Act. Neither party shall invoke the Cooperative Research and Technology  Enhancement Act (“CREATE Act”) in connection with the Prosecution or Maintenance  of any Pieris Platform IP, Pieris Platform Improvement IP or Key IP without the prior  written consent of the other Party.    Defense.   If the Exploitation of any Product pursuant to this Agreement results in any  claim, suit or proceeding alleging patent infringement or trade secret  misappropriation against Pieris or BP, then such Party shall promptly notify the  other Party hereto. 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 a Patent owned by or licensed to it is infringed  by the Exploitation of a Product or that its trade secrets were misappropriated in  connection with such activity, then BP shall have the full and unrestricted right and  responsibility to resolve any such claim, whether by obtaining a license from such  Third Party, by defending against such Third Party’s claims or otherwise, and shall  be solely responsible for the defense of any such action, any and all costs incurred  in connection with such action (including attorneys’ and expert fees) and all  liabilities incurred in connection therewith. Notwithstanding the above, BP shall  not enter into any settlement of any such claim without the prior written consent of  Pieris if such settlement would require Pieris to be subject to an injunction or to  make any monetary payment to BP or any Third Party, or admit any wrongful  conduct by Pieris or its Affiliates, or would limit or restrict the claims of or admit  any invalidity and/or unenforceability of any of the Patents Controlled by Pieris, or  have any material adverse impact on Pieris’ development of Anticalin-based  therapeutics.   Enforcement.  

 

[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.]    Execution Version  Page 49 of 94      GDSVF&H\6023374.4   If either Party believes that an infringement, unauthorized use,  misappropriation or ownership claim or threatened infringement or other such  activity by a Third Party with respect to any Intellectual Property Rights licensed  or created under this Agreement, the Party possessing such knowledge or belief  shall notify the other Party and provide it with details of such infringement or claim  that are known by such Party. In the event that Pieris believes that a BP Patent, if  any, is being infringed by a Third Party or if a Third Party claims to Pieris that any  BP Patent is invalid or unenforceable, Pieris shall notify BP and provide it with  details of such infringement or claim.   BP shall have the full and unrestricted right, but not the obligation, to bring  and control an appropriate suit or other action against any person or entity engaged  in any infringement action or proceeding to the extent directly relating to Key IP  and any Product in the Field and in the Territory (“Infringement Action”), in its  own name and entirely under its own direction and control (including, for the  avoidance of doubt, the compromise or settlement thereof). In the event that BP  does not wish to enforce such Patents against such a potential infringer, then BP  shall deliver prompt written notice thereof to Pieris. If BP requests so, Pieris shall  reasonably cooperate with BP in the planning and execution of any such action to  enforce such Patents (including the obligation to be named or joined as a party in a  lawsuit, as applicable, the performance of such obligation shall be deemed to be  reasonable cooperation). Notwithstanding the foregoing, if BP does not either  initiate such an Infringement Action or grant adequate rights and licenses to such  Third Party within [***] days after BP’s receipt of a notice of infringement (or  sooner if any deadlines require action prior to such [***] days), then Pieris will  have the second right, but not the obligation, to initiate such Infringement Action.  BP shall have the right to join any Pieris Infringement Action at its own expense.     Monies recovered upon the final judgment or settlement of any such suit or  action to enforce such Patents subtracting any costs that the Parties bore in  connection with such suit or action, shall be treated either: (a) as Net Sales to the  extent such monies recovered are designated as lost profits, or (b) shall otherwise  be divided between the Parties with [***] ([***]%) paid by the enforcing Party to  the non-enforcing Party and [***] ([***]%) retained by enforcing Party (with  portion received by BP not treated as Net Sales or Consideration).   For the avoidance of doubt and without limiting BP’s rights elsewhere in this  Agreement, BP shall have the right, in its sole discretion, to delegate its rights under  Section 9.6 or Section 9.7 in whole or in part in connection with a Sublicense or  otherwise to a Sublicensee.   For avoidance of doubt, BP shall not have the right to assert or enforce any  other Patents owned or Controlled by Pieris under this Agreement, such as the  

 

[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.]    Execution Version  Page 50 of 94      GDSVF&H\6023374.4  Patent Rights within the Other Pieris IP, against a Third Party under any  circumstances and Pieris shall not be under any obligation to enforce such Patent  Rights; provided, Pieris shall consider in good faith any request by BP to enforce  the Other IP to the extent related to any Product in the Field and in the Territory  and to the extent that Pieris consents (such consent not unreasonably withheld,  conditioned or delayed to the extent that such Other IP does not Cover any other  products other than the Product and is not licensed to any Third Party other than  BP) to enforce such Other IP, the Parties shall agree upon the allocation of  responsibility (with the default being that Pieris shall be in the lead) for such suit  and any monies received shall be treated as set forth in Section 9.7.3. For avoidance  of doubt, Pieris shall not enforce the Other IP in relation to the Product (i.e., a  Biosimilar) in the absence of BP’s request.   Neither Party may settle or otherwise compromise any action contemplated  by this Section 9.7 in a way that adversely affects or would be reasonably expected  to materially, adversely affect the other Party’s rights or benefits hereunder, without  that Party’s prior written consent.   Common Interest Disclosures. With regard to any information or opinions disclosed  pursuant to this Agreement by one Party to each other regarding Intellectual Property  Rights 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 Product Development Plan and/or 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 Product Development Plan and/or Products.  Accordingly, the Parties agree that all such information and materials obtained by Pieris  and BP 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.   Patent Term Extensions. BP 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”) for each Product with respect to the Key IP.  Pieris shall execute such authorizations and other documents and take such other actions  as may be reasonably requested by BP to obtain such Patent Term Extensions. All filings  

 

[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.]    Execution Version  Page 51 of 94      GDSVF&H\6023374.4  for such Patent Term Extensions shall be made by BP; provided, that in the event that BP  elects not to file for a Patent Term Extension, BP 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, extensions  and/or SPCs wherever applicable to such Patents. For avoidance of doubt, BP shall not be  permitted to apply for any Patent Term Extensions using the Other Pieris IP without the  prior written consent of Pieris.   10. CONFIDENTIALITY & PUBLICATION   Nondisclosure Obligation.   All Confidential Information disclosed. directly or indirectly, by one Party  (the “Disclosing Party”) to the other Party (the “Receiving Party”) under this  Agreement will be maintained in confidence by the Receiving Party and will not be  disclosed to a Third Party or used for any purpose except to exercise its licenses  and other rights, to perform its obligations, or as otherwise set forth herein, without  the prior written consent of the Disclosing Party, except to the extent that such  Confidential Information:  (a) is known by the Receiving Party at the time of its receipt, and not  through a prior disclosure by the Disclosing Party, as documented by the  Receiving Party’s business records;  (b) is known to the public before its receipt from the Disclosing Party, or  thereafter becomes generally known to the public through no breach of this  Agreement by the Receiving Party;  (c) is subsequently disclosed to the Receiving Party by a Third Party who  is not known by the Receiving Party to be under an obligation of  confidentiality to the Disclosing Party; or  (d) is developed by the Receiving Party independently of Confidential  Information received from the Disclosing Party, as documented by the  receiving Party’s business records.   Specific aspects or details of Confidential Information will not be deemed  to be within the public domain or in the possession of the Receiving Party merely  because the Confidential Information is embraced by more general information in  the public domain or in the possession of the Receiving Party. Further, any  combination of Confidential Information will not be considered in the public  

 

[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.]    Execution Version  Page 52 of 94      GDSVF&H\6023374.4  domain or in the possession of the recipient Party merely because individual  elements of such Confidential Information are in the public domain or in the  possession of the Receiving Party unless the combination and its principles are in  the public domain or in the possession of the Receiving Party. Notwithstanding  anything to the contrary, except as required by Applicable Law, Pieris shall not  publish or otherwise disclose to a Third Party Confidential Information related to a  Product except as permitted under or contemplated by this Agreement, until it has  complied with the provisions of Section 10.2.   Notwithstanding the obligations of confidentiality and non-use set forth  above and in Section 10.1.4 below, a Receiving Party may provide Confidential  Information disclosed to it, and disclose the existence and terms of this Agreement  as may be reasonably required in order to perform its obligations and to exploit its  licenses and other rights under this Agreement, or in connection with financing  transactions, and specifically (a) to Affiliates and Sublicensees, and their  employees, directors, agents, consultants, or advisors to the extent necessary for the  potential or actual performance of its obligations or exercise of its licenses and other  rights under this Agreement, or in connection with financing transactions, in each  case who have a bona fide need to know such information and are under an  obligation of confidentiality with respect to such information that is no less  stringent than the terms of this Section 10.1; (b) to a Governmental Authority,  including any other Regulatory Authorities (including in order to exploit its rights  under this Agreement) or perform its obligations under this Agreement, provided  that such Confidential Information will be disclosed only to the extent reasonably  necessary to do so, and where permitted, subject to confidential treatment; (c) to  the extent required by Applicable Law, including by the rules or regulations of the  SEC or similar Regulatory Authority in a country other than the United States or of  any stock exchange or listing entity; (d) with respect to the terms of this Agreement  only, to any bona fide actual or prospective acquirers, underwriters, investors,  lenders or other financing sources and any bona fide actual or prospective  collaborators, licensors, Sublicensees, licensees or strategic partners and to  employees, directors, agents, consultants and advisers of such Third Party, in each  case who are under an obligation or confidentiality with respect to such information  that is no less stringent than the terms of this Section 10.1 (but of duration  customary in confidentiality agreements entered into for a similar purpose) and (e)  to Third Parties to the extent a Party is required to do so pursuant to the terms of an  in-license provided that the material terms of such in-license have been disclosed  to the Disclosing Party. If a Party is required by Applicable Law to disclose  Confidential Information of the other Party that is subject to the non-disclosure  provisions of this Section 10.1, such Party will promptly inform the other Party of  the disclosure that is being sought in order to provide the other Party an opportunity  to challenge or limit the disclosure.  

 

[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.]    Execution Version  Page 53 of 94      GDSVF&H\6023374.4   Notwithstanding Section 10.1.1, Confidential Information that is permitted  or required to be disclosed will remain otherwise subject to the confidentiality and  non-use provisions of this Section 10.1. If either Party concludes that a copy of this  Agreement must be filed with the SEC or similar regulatory agency in a country  other than the United States, such Party will, a reasonable time prior to any such  filing, provide the other Party with a copy of such agreement showing any  provisions hereof as to which the Party proposes to request confidential treatment,  will provide the other Party with an opportunity to comment on any such proposed  redactions and to suggest additional redactions, and will take such Party’s  reasonable comments into consideration before filing such agreement and use  Commercially Reasonable Efforts to have terms identified by such other Party  afforded confidential treatment by the applicable regulatory agency.   Publication and Publicity.   Publication. Except for disclosures permitted pursuant to Section 10.1 and  Section 10.2.2, if (a) Pieris wishes to make a publication or public presentation  relating to: (i) a Product or (ii) any results of Research and Development activities  under this Agreement or (b) either Party wishes to make a publication or public  presentation relating to any jointly carried out activity that contains the Confidential  Information of the other Party (the “Publishing Party”), the Publishing Party will  deliver to the other Party (the “Reviewing Party”) a copy of the proposed written  publication or presentation at least [***] days prior to submission for publication  or presentation. The Reviewing Party shall notify the Publishing Party within [***]  days of receipt of such publication or presentation: (x) of its intent to propose  modifications to such publication or presentation for Patent reasons or trade secret  reasons or to remove Confidential Information of the Reviewing Party or its  Affiliates, or (y) to request a reasonable delay in submission or presentation in order  to protect patentable information. If the Reviewing Party notifies the Publishing  Party of its intent to propose modifications, if requested by the Reviewing Party  within [***] days of such notice, the Publishing Party will remove all Confidential  Information of the Reviewing Party and otherwise take such Party’s reasonable  comments into consideration in good faith. If the Reviewing Party requests a delay  in order to protect patentable information, the Publishing Party will delay  submission or presentation for a period of [***] days (or such shorter period as may  be mutually agreed by the Parties) to enable the Reviewing Party to file patent  applications protecting such Party’s rights in such information. The Publishing  Party may submit or present such publication or presentation upon the earlier of  expiration of such [***] days (or such shorter period as may be mutually agreed by  the Parties) and the date the Reviewing Party has filed such patent applications. For  the avoidance of doubt, if the Reviewing Party does not: (1) notify the Publishing  Party within [***] days of receipt of such publication or presentation, or (2) provide  

 

[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.]    Execution Version  Page 54 of 94      GDSVF&H\6023374.4  proposed modifications within [***] days of such notice, in each case (1) and (2),  the Publishing Party may submit or present such publication or presentation. With  respect to any proposed publications or disclosures by investigators or academic or  non-profit collaborators, such materials will be subject to review under this Section  10.2.1 (in the case of BP to the extent that BP has the right and ability (after using  Commercially Reasonable Efforts to obtain such right and ability) to do so).    Publicity. Except as set forth in Section 10.1, Section 10.2.1 and Section  10.3, the terms of this Agreement may not be disclosed by either Party, and neither  Party will use the name or Trademark of the other Party or its employees in any  publicity, news release or disclosure relating to this Agreement, its subject matter,  or the activities of the Parties hereunder without the prior express written  permission of the other Party except (a) as may be required by Applicable Law,  including by the rules or regulations of the SEC or similar Regulatory Authority in  any country other than the United States or of any stock exchange or listing entity,  provided that the Party issuing such press release gives reasonable notice prior to  use of such name or Trademark of the other Party, and otherwise complies with  Section 10.3.2, or (b) as expressly permitted by the terms hereof.   Press Release.    Initial Press Release. The Parties agree to issue the joint press release  attached hereto as Exhibit 10.3.1 on the Effective Date.    Further Press Releases.    Except as provided in this Section 10.3, neither Party will issue a  press release or public announcement relating to this Agreement without the  prior written approval of the other Party (such approval not to be  unreasonably withheld, conditioned or delayed), except that a Party may (a)  once a press release or other public statement is approved in writing by both  Parties, make subsequent public disclosure of the information contained in  such press release or other written statement without the further approval of  the other Party, and (b) issue a press release or public announcement as  required by Applicable Law (including a press release corresponding to any  securities disclosure, such as pursuant to a Form 8-K), including by the rules  or regulations of the SEC or similar Regulatory Authority in a country other  than the United States or of any stock exchange or listing entity, provided  that the Party issuing such press release gives reasonable prior notice to the  other Party of and the opportunity to comment on the press release or public  announcement, and otherwise complies with this Section 10.3. In addition,  Pieris may, with BP’s prior written approval, such approval not to be  unreasonably withheld, conditioned or delayed, issue a press release  

 

[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.]    Execution Version  Page 55 of 94      GDSVF&H\6023374.4  regarding (x) the sublicense of the Product by BP or (y) the payment or  receipt of any milestone payments under this Agreement with respect to the  Product, provided, that such press release otherwise complies with this  Section 10.3.   Subject to its confidentiality obligations, BP shall have the right  to make press releases related to the Product as it chooses, in its sole  discretion, without the approval of Pieris. BP shall provide notice and a  copy of such press release reasonably in advance of disclosure.   11. REPRESENTATIONS & WARRANTIES   Representations, Warranties and Covenants of Both Parties. Each Party hereby  represents and warrants as of the Effective Date, and covenants, to the other Party that:   such Party is duly organized and validly existing under the Applicable Law  of the jurisdiction of its incorporation or organization;   it has the power, authority and the legal right to enter into this Agreement  and perform its obligations hereunder, and that it has taken all necessary action on  its part required to authorize the execution and delivery of this Agreement and the  performance of its obligations hereunder;   this Agreement has been duly executed and delivered on behalf of such  Party and constitutes a legal, valid and binding obligation of such Party and is  enforceable against it in accordance with its terms subject to the effects of  bankruptcy, insolvency or other laws of general application affecting the  enforcement of creditor rights and judicial principles affecting the availability of  specific performance and general principles of equity, whether enforceability is  considered a proceeding at law or equity;   to the extent required, all necessary consents, approvals and authorizations  of other parties required to be obtained by such Party in connection with the  execution and delivery of this Agreement and the performance of its obligations  hereunder have been obtained;    the execution and delivery of this Agreement and the performance of such  Party’s obligations hereunder (a) do not conflict with or violate any requirement of  Applicable Law or any provision of the certificate of incorporation, bylaws or any  similar instrument of such Party, as applicable, in any material way, and (b) do not  conflict with, violate, or breach or constitute a default or require any consent not  already obtained under, any contractual obligation or court or administrative order  by which such Party is bound;  

 

[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.]    Execution Version  Page 56 of 94      GDSVF&H\6023374.4   no consent by any Third Party or Governmental Authority is required with  respect to the execution and delivery of this Agreement by either Party or the  consummation by either Party of the transactions contemplated hereby;   it will perform its activities pursuant to this Agreement in all material  respects:   in compliance with good laboratory and clinical practices and  cGMP and Applicable Law; and   with respect to the care, handling and use in Development  activities hereunder of any nonhuman animals by or on behalf of such Party,  will at all times comply (and will ensure compliance by any of its  subcontractors) with all Applicable Law of the country and the state and  local government wherein such activities are conducted; and    such Party is not debarred under the United States Federal Food, Drug and  Cosmetic Act or comparable Applicable Law and it does not, and will not during  the Term, employ or use the services of any Person who is debarred, in connection  with the Development, Manufacture or Commercialization of the Product. If either  Party becomes aware of the debarment or threatened debarment of any Person  providing services to such Party, including the Party itself and its Affiliates or  Sublicensees, which directly or indirectly relate to activities under this Agreement,  the other Party will be immediately notified in writing.   Representations, Warranties and Covenants of BP. BP hereby represents and  warrants to Pieris, as of the Effective Date and covenants, that (except as disclosed to Pieris  in writing):    BP is a wholly-owned subsidiary of Boston Pharma.    The Board of Managers of Boston Pharma has authorized BP to enter into  this Agreement and has allocated an initial budget of up to [***] Dollars ($[***])  in the aggregate for the costs and expenses related to this Agreement. For the  avoidance of doubt, this Section 11.2 (including the information contained herein)  is and shall be the Confidential Information of BP.   Representations, Warranties and Covenants of Pieris. Pieris hereby represents  and warrants to BP, as of the Effective Date and covenants, that (except as disclosed to BP  in writing):    Pieris is the owner of, or otherwise has the right to grant the rights and  licenses it purports to grant to BP with respect to the Pieris IP (including the 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.]    Execution Version  Page 57 of 94      GDSVF&H\6023374.4  IP) under this Agreement without violating any right of or breaching any obligation  to any Person;    to Pieris’ knowledge, there is no material unauthorized use, infringement or  misappropriation of the Pieris IP;    the Pieris Patents (including the Product Patents) are subsisting and have  been filed and maintained properly and correctly in all material respects and are not  the subject of any litigation procedure, discovery process, interference, reissue,  reexamination, opposition, or appeal proceedings;    Pieris has not previously entered into any agreement, whether written or  oral, with respect to, or otherwise assigned, transferred, licensed, conveyed or  otherwise encumbered its right, title or interest in or to, the Pieris IP (including by  granting any covenant not to sue with respect thereto) that is inconsistent with the  rights and licenses granted to BP under this Agreement, and it will not enter into  any such agreements or grant any such right, title or interest to any Person that is  inconsistent with the rights and licenses granted to BP under this Agreement;   Each of the Pieris Patents (including the Product Patents) properly identifies  each and every inventor of the claims thereof as determined in accordance with the  laws of the jurisdiction in which such Patent issued or such application is pending;   Pieris has not received any written claim alleging, and does not have  knowledge of any fact or circumstance indicating, that any of the Pieris IP is invalid  or unenforceable;   Pieris has not received any written claim alleging, and does not have  knowledge of any fact or circumstance indicating, that any of Pieris’ activities  relating to Product or the practice of the Pieris Platform Technology infringe or  misappropriate any Intellectual Property Rights of a Third Party;    Pieris has not received any written claim or notice of dispute from any  Person relating to the Pieris IP including any dispute with a licensor and does not  have any knowledge of any fact or circumstance indicating that a claim or dispute  could arise;   there are no additional licenses (beyond those provided in this Agreement  and the Known Third-Party Obligations) under any Intellectual Property Rights  Controlled by Pieris or its Affiliates as of the Effective Date, that would be  necessary in order for BP to Exploit the Product as contemplated 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.]    Execution Version  Page 58 of 94      GDSVF&H\6023374.4   it has the full right to provide BP with the [***] and [***] (subject to the  Product Cell Line License), and the purified protein set forth in Exhibit 4.3.2;   Pieris is not and as far as Pieris is aware, the counter party is not in breach  of the Product Cell Line License;   Pieris and its Affiliates have not conducted any Clinical Studies with any  Product and has conducted, and has required its contractors and consultants to  conduct, where applicable, preclinical studies related to each Product in compliance  with good laboratory and clinical practices and cGMP and Applicable Law, in each  case as applicable under the laws and regulations of the country and the state and  local government wherein such activities were conducted;   true and complete copies of all material information, documents and data  relating to the Product and the Pieris Platform Technology (including all  toxicology, safety and efficacy data) in the possession or control of Pieris or its  Affiliates have been provided to BP;    all tangible information and data (including Materials and Data) provided  by or on behalf of Pieris to BP on or before the Effective Date related to the Product  in contemplation of this Agreement was and is true, accurate and complete in all  material respects, and Pieris has not failed to disclose, or cause to be disclosed, any  information or data that would cause such information and data that has been  disclosed to be misleading in any material respect.  

 

[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.]    Execution Version  Page 59 of 94      GDSVF&H\6023374.4  12. INDEMNIFICATION, LIABILITY & INSURANCE   Indemnification by BP. BP agrees to defend Pieris, its Affiliates and their respective  directors, officers, stockholders, employees and agents, and their respective successors,  heirs and assigns (collectively, the “Pieris Indemnitees”), and will indemnify and hold  harmless the Pieris Indemnitees, from and against any liabilities, losses, costs, damages,  fees or expenses payable to a Third Party, and reasonable attorneys’ fees and other legal  expenses with respect thereto (collectively, “Losses”) arising out of any claim, action,  lawsuit or other proceeding by a Third Party (collectively, “Third Party Claims”) brought  against any Pieris Indemnitee and resulting from or occurring as a result of: (a) any  activities conducted by a BP employee, consultant or (sub)contractor in the performance  of the BP Conducted Activities, (b) the performance by BP or its Affiliates, Sublicensees,  distributors or contractors of BP’s obligations under this Agreement, (c) any breach by BP  of any of its representations, warranties or covenants set forth in Section 11.1, or (d) the  negligence or willful misconduct of BP or any BP Affiliate or Sublicensee in the  performance of this Agreement; except in any such case to the extent such Losses result  from: (i) the negligence or willful misconduct of any Pieris Indemnitee, (ii) any breach by  Pieris of any of its representations, warranties, covenants or obligations pursuant to this  Agreement, or (iii) any breach of Applicable Law by any Pieris Indemnitee.   Indemnification by Pieris. Pieris agrees to defend BP, its Affiliates and their  respective directors, officers, stockholders, employees and agents, and their respective  successors, heirs and assigns (collectively, the “BP Indemnitees”), and will indemnify and  hold harmless the BP Indemnitees, from and against any Losses arising out of (a) Third  Party Claims brought against any BP Indemnitee and resulting from or occurring as a result  of: (i) any activities conducted by a Pieris employee, consultant or (sub)contractor in the  performance of the Pieris Conducted Activities, (ii) any breach by Pieris of any of its  representations, warranties or covenants set forth in Section 11.1 and Section 11.3, (iii) the  negligence or willful misconduct of any Pieris Indemnitee or any (sub)contractor of Pieris  in the performance of this Agreement, or (iv) the Development, Manufacture or  Commercialization of any Product by Pieris or its Affiliates, Sublicensees, distributors or  contractors; and (b), any Losses arising out of any dispute between Pieris and the [***]  under the Research and License Agreement by and between Pieris and [***], dated as of  [***] and superseded and replaced on [***] (the “[***] License Agreement”) including  any termination of that agreement except in any such case to the extent such Losses result  from: (x) the negligence or willful misconduct of any BP Indemnitee, (y) any breach by  BP of any of its representations, warranties, covenants or obligations pursuant to this  Agreement, or (z) any breach of Applicable Law by any BP Indemnitee.   Notice of Claim. All indemnification claims provided for in Section 12.1 and Section  12.2 will be made solely by such Party to this Agreement (the “Indemnified Party”). The  Indemnified Party will give the indemnifying Party prompt written notice (an  “Indemnification Claim Notice”) of any Losses or the discovery of any fact upon 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.]    Execution Version  Page 60 of 94      GDSVF&H\6023374.4  the Indemnified Party intends to base a request for indemnification under Section 12.1 or  Section 12.2, but in no event will the indemnifying Party be liable for any Losses to the  extent such Losses result from any delay in providing such Indemnification Claim Notice.  Each Indemnification Claim Notice must contain a description of the claim and the nature  and amount of such Loss (to the extent that the nature and amount of such Loss is known  at such time). The Indemnified Party will furnish promptly to the indemnifying Party  copies of all papers and official documents received in respect of any Losses and Third  Party Claims.   Defense, Settlement, Cooperation and Expenses.   Control of Defense. At its option, the indemnifying Party may assume the  defense of any Third Party Claim by giving written notice to the Indemnified Party  within [***] days after the indemnifying Party’s receipt of an Indemnification  Claim Notice. The assumption of the defense of a Third Party Claim by the  indemnifying Party will not be construed as an acknowledgment that the  indemnifying Party is liable to indemnify the Indemnified Party in respect of the  Third Party Claim, nor will it constitute a waiver by the indemnifying Party of any  defenses it may assert against the Indemnified Party’s claim for indemnification.  Upon assuming the defense of a Third Party Claim, the indemnifying Party may  appoint as lead counsel in the defense of the Third Party Claim any legal counsel  selected by the indemnifying Party. In the event the indemnifying Party assumes  the defense of a Third Party Claim, the Indemnified Party will as soon as reasonably  possible deliver to the indemnifying Party all original notices and documents  (including court papers) received by the Indemnified Party in connection with the  Third Party Claim. Should the indemnifying Party assume the defense of a Third  Party Claim, except as provided in this Section 12.4.1, the Indemnified Party will  be responsible for the legal costs or expenses subsequently incurred by such  Indemnified Party in connection with the analysis, defense or settlement of the  Third Party Claim.   Right to Participate in Defense. Without limiting Section 12.4.1, any  Indemnified Party will be entitled to participate in, but not control, the defense of  such Third Party Claim and to employ counsel of its choice for such purpose;  provided, however, that such employment will be at the Indemnified Party’s own  cost and expense unless (a) the employment thereof has been specifically  authorized by the indemnifying Party in writing, (b) the indemnifying Party has  failed to assume the defense and employ counsel in accordance with Section 12.4.1  (in which case the Indemnified Party will control the defense), or (c) the interests  of the Indemnified Party and the indemnifying Party with respect to such Third  Party Claim are sufficiently adverse to prohibit the representation by the same  counsel of both Parties under Applicable Law, ethical rules or equitable principles  in which case the indemnifying Party will be responsible for any such costs and  

 

[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.]    Execution Version  Page 61 of 94      GDSVF&H\6023374.4  expenses of counsel for the Indemnified Party.   Settlement. With respect to any Third Party Claims relating solely to the  payment of money damages in connection with a Third Party Claim and that will  not admit liability or violation of Applicable Law on the part of the Indemnified  Party or result in the Indemnified Party’s becoming subject to injunctive or other  relief or otherwise materially, adversely affecting the business of the Indemnified  Party in any manner (such as granting a license or admitting the invalidity of a  Patent Controlled by an Indemnified Party), and as to which the indemnifying Party  will have acknowledged in writing the obligation to indemnify the Indemnified  Party hereunder, the indemnifying Party will have the sole right to consent to the  entry of any judgment, enter into any settlement or otherwise dispose of such Loss,  on such terms as the indemnifying Party, in its sole discretion, will deem  appropriate. With respect to all other Losses in connection with Third Party Claims,  where the indemnifying Party has assumed the defense of the Third Party Claim in  accordance with Section 12.4.1, the indemnifying Party will have authority to  consent to the entry of any judgment, enter into any settlement or otherwise dispose  of such Loss provided it obtains the prior written consent of the Indemnified Party  (which consent will not be unreasonably withheld). The indemnifying Party will  not be liable for any settlement, consent to entry of judgment, or other disposition  of a Loss by an Indemnified Party that is reached without the written consent of the  indemnifying Party. Regardless of whether the indemnifying Party chooses to  defend or prosecute any Third Party Claim, no Indemnified Party will admit any  liability with respect to or settle, compromise or discharge, any Third Party Claim  without the prior written consent of the indemnifying Party, such consent not to be  unreasonably withheld.   Cooperation. Regardless of whether the indemnifying Party chooses to  defend or prosecute any Third Party Claim, the Indemnified Party will, and will  cause each other Indemnified Party to, cooperate in the defense or prosecution  thereof and will furnish such records, information and testimony, provide such  witnesses and attend such conferences, discovery proceedings, hearings, trials and  appeals as may be reasonably requested in connection therewith. Such cooperation  will include access during normal business hours afforded to indemnifying Party  to, and reasonable retention by the Indemnified Party of, records and information  that are reasonably relevant to such Third Party Claim, and making Indemnified  Parties and other employees and agents available on a mutually convenient basis to  provide additional information and explanation of any material provided hereunder,  and the indemnifying Party will reimburse the Indemnified Party for all its  reasonable Out-of-Pocket Costs and expenses in connection therewith.   Costs and Expenses. Except as provided above in this Section 12.4, the costs  and expenses, including attorneys’ fees and expenses, incurred by the Indemnified  

 

[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.]    Execution Version  Page 62 of 94      GDSVF&H\6023374.4  Party in connection with any claim will be reimbursed on a Calendar Quarter basis  by the indemnifying Party, without prejudice to the indemnifying Party’s right to  contest the Indemnified Party’s right to indemnification and subject to refund in the  event the indemnifying Party is ultimately held not to be obligated to indemnify the  Indemnified Party.   [***].    Boston Pharma [***] under this Agreement (including for avoidance of  doubt, [***]) (collectively, the “[***]”); provided that, this [***] shall terminate  and cease to be of any further force or effect at such time when BP is no longer an  Affiliate of Boston Pharma.   BPInc [***] under this Agreement (collectively, the “[***]”); provided that,  this [***] shall terminate and cease to be of any further force or effect at such time  when BP is no longer an Affiliate of BPInc.   Boston Pharma hereby waives (a) all notices of the creation, renewal,  extension, accrual or amendment of any of the [***] and notice of proof of reliance  by Pieris on the [***] or acceptance of the [***]; (b) [***]; and (c) [***].    BPInc hereby waives (a) all notices of the creation, renewal, extension,  accrual or amendment of any of the [***] and notice of proof of reliance by Pieris  on [***]; (b) [***]; and (c) [***].    Insurance. Each Party will maintain, at its cost, reasonable insurance against liability  and other risks associated with its activities contemplated by this Agreement, including its  indemnification obligations herein, in such amounts and on such terms as are customary  for prudent practices for biotech companies of similar size and with similar resources in  the pharmaceutical industry (in the case of BP the size and resources of BP shall include  Boston Pharma and its subsidiaries) for the activities to be conducted by it under this  Agreement taking into account the scope of development of Products. Each Party will  furnish to the other Party evidence of such insurance, upon request. It is understood and  agreed that this insurance shall not be construed to limit either Party’s liability with respect  to its indemnification obligations hereunder.   LIMITATION OF CONSEQUENTIAL DAMAGES. EXCEPT FOR (A)  CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER SECTION 12.1 OR  SECTION 12.2, (B) CLAIMS ARISING OUT OF A PARTY’S BREACH OF ITS  CONFIDENTIALITY OBLIGATIONS UNDER THIS AGREEMENT, OR (C)  SECTION 7.2 OR SECTION 14.2.2, NEITHER PARTY NOR ANY OF ITS  AFFILIATES WILL BE LIABLE TO THE OTHER PARTY TO THIS AGREEMENT  OR ITS AFFILIATES FOR ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL,  

 

[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.]    Execution Version  Page 63 of 94      GDSVF&H\6023374.4  PUNITIVE OR OTHER INDIRECT DAMAGES OR LOST OR IMPUTED PROFITS OR  ROYALTIES, LOST DATA OR COST OF PROCUREMENT OF SUBSTITUTE  GOODS OR SERVICES, WHETHER LIABILITY IS ASSERTED IN CONTRACT,  TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY),  INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT  PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF,  OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH  LOSS OR DAMAGE.   Anti-Bribery and Corruption Compliance.    Each Party agrees, on behalf of itself, its officers, directors and employees  and on behalf of its Affiliates that it will, and will use its diligent efforts to, procure  that its agents, representatives, consultants and subcontractors hired for activities  undertaken for or in connection with the performance of this Agreement, (together  with such Party, the “Party Representatives”) for the performance of its  obligations hereunder that such Party Representatives will not directly or indirectly  pay, offer or promise to pay, or authorize the payment of any money, or give, offer  or promise to give, or authorize the giving of anything else of value, to:   any Government Official in order to influence official action;   any Person (whether or not a Government Official) (i) to influence  such Person to act in breach of a duty of good faith, impartiality or trust  (“Improper Action”), (ii) to reward such Person for such Improper Action,  or (iii) where such Person would engage in an Improper Action by receiving  the money or other thing of value;    any other Person while knowing or having reason to know that all  or any portion of the money or other thing of value will be paid, offered,  promised or given to, or will otherwise benefit, a Government Official in  order to influence official action for or against either Party in connection  with the matters that are the subject of this Agreement; or   any Person to reward that Person for an Improper Action or to  induce that Person to engage in Improper Action.   Each Party will not and will use diligent efforts to procure that its Party  Representatives will not, directly or indirectly, solicit, receive or agree to accept  any payment of money or anything else of value in violation of the Anti-Corruption  Laws.   Each Party acknowledges that its undertakings given in Section 12.8.1 and  

 

[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.]    Execution Version  Page 64 of 94      GDSVF&H\6023374.4  Section 12.8.2 are material to the other Party in entering into a relationship with  such Party.   Each Party, on behalf of itself and its Party Representatives, represents and  warrants to the other Party that for the term of this Agreement and [***] years  thereafter, it will and will use diligent efforts to procure that its Party  Representatives keep and maintain accurate books and reasonably detailed records  in connection with the performance of its obligation under this Agreement  including all records required to establish compliance with Section 12.8.1 and  Section 12.8.2 above.   Each Party will promptly provide the other Party with written notice of the  following events: (a) upon becoming aware of any material breach or violation by  it or its Party Representatives of any representation, warranty or undertaking set  forth in Section 12.8.1 and Section 12.8.2; and (b) upon receiving a formal  notification that it is the target of a formal investigation by a Governmental  Authority for a Material Anti-Corruption Law Violation or upon receipt of  information from any of its Party Representatives connected with this Agreement  that any of them is the target of a formal investigation by a Governmental Authority  for a material violation of Anti-Corruption Law.   For the term of this Agreement and [***] years thereafter, each Party will  for the purpose of auditing and monitoring the performance of its compliance with  this Section 12.8 permit the other Party, its Affiliates, any auditors of any of them  and any Regulatory Authority to have access to any premises of such Party and to  the extent that such Party is able to secure such access, its Party Representatives in  each case used in connection with this Agreement, together with a right to access  personnel and records that relate to this Agreement (“Audit”).    Each Party will be responsible for any breach of any representation,  warranty or undertaking in this Section 12.8 or of the Anti-Corruption Laws by any  of its Party Representatives.    Each Party may disclose the terms of this Agreement or any action taken  under this Section 12.8 to prevent a potential violation or continuing violation of  applicable Anti-Corruption Laws, including the identity of the other Party and the  payment terms, to any Governmental Authority if such Party determines, upon  advice of counsel, that such disclosure is necessary.  

 

[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.]    Execution Version  Page 65 of 94      GDSVF&H\6023374.4  13. TERM AND TERMINATION   Agreement Term. The term of this Agreement (the “Term”) will commence on the  Effective Date and will extend, unless this Agreement is terminated earlier in accordance  with Section 13.2, on a Product-by-Product basis until such time as BP’s payment  obligations with respect to the sale of such Product in all countries expires.  Upon the  natural expiration (as opposed to termination) of BP’s payment obligations with respect to  a Product the licenses granted by Pieris to BP under this Agreement with respect to such  Product shall remain in effect as granted in accordance with this Agreement and shall  become perpetual, irrevocable, fully paid-up, royalty-free and sublicensable without  restriction through multiple tiers.   Termination. Notwithstanding anything in this Agreement or elsewhere to the  contrary, subject to Section 13.3.3 below, this Agreement may be terminated as follows:   Termination for Material Breach. Either Party shall have the right to  terminate this Agreement in the event the other Party has materially breached or  materially defaulted in the performance of any of its obligations hereunder which  breach or default is material in the overall context of the Agreement, and such  breach has continued for [***] days (or [***] days in the case of non-payment of  undisputed amounts due and payable) after written notice thereof was provided to  the breaching Party by the non-breaching Party which clearly describes the  remedies that the non-breaching Party intends to apply should the breach remain  uncured. Any such termination shall become effective at the end of such [***] day  (or [***] day with respect to non-payment of undisputed amounts due and payable)  period if, prior to the expiration of the [***] day (or [***] day, as applicable) period,  the breaching Party has not cured any such breach or default. In the event that the  breach is not susceptible to cure during such [***] day period, then, upon written  notice to the non-breaching Party during the initial [***] day period, the breaching  Party may have additional time, not to exceed another [***] days to cure such  breach.  If the allegedly breaching Party disputes the breach and provides written  notice of that dispute to the other Party, the matter shall be addressed under the  dispute resolution provisions in Section 14.1, and the notifying Party may not  terminate this Agreement until it has been finally determined under Section 14.1,  that the Agreement was materially breached as described above and the breaching  Party does not cure the breach within a reasonable time as determined by the dispute  resolution provisions in Section 14.1 (including arbitration under Section 14.1.4.1  below).   Termination by Mutual Agreement. This Agreement may be terminated by  the mutual written consent of the Parties.   Termination by BP for Convenience. BP may terminate this Agreement 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.]    Execution Version  Page 66 of 94      GDSVF&H\6023374.4  its entirety or on a Product-by-Product basis by providing [***] days’ prior written  notice to Pieris (unless the Product has achieved Marketing Approval, in which case  such period shall be [***] days). Notwithstanding the foregoing, BP may not  terminate this Agreement within the first [***] months following the Effective  Date.    Termination for Insolvency. Either Party may terminate this Agreement if,  at any time, the other Party will file in any court or agency pursuant to any statute  or regulation of any state or country, a petition in bankruptcy or insolvency or for  the appointment of a receiver or trustee of the Party or of substantially all of its  assets, or if the other Party proposes a written agreement of composition or  extension of substantially all of its debts, or if the other Party will be served with  an involuntary petition against it, filed in any insolvency proceeding, and such  petition will not be dismissed within [***] days after the filing thereof, or if the  other Party will propose or be a party to any dissolution or liquidation, or if the  other Party will make an assignment of substantially all of its assets for the benefit  of creditors.  Upon the bankruptcy of any Party, the non-bankrupt Party will further  be entitled to a complete duplicate of, or complete access to, any such intellectual  property, and such, if not already in its possession, will be promptly delivered to  the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues,  to perform all of its obligations under this Agreement.    Termination for Patent Challenge. Pieris may terminate this Agreement if  BP or its Affiliates disputes, or assists any Third Party to dispute, the validity of  any Patent within the Pieris IP in a patent re-examination, inter partes review, post- grant or other patent office proceeding, opposition, litigation, or other court  proceeding and, within [***] days written notice from Pieris, BP or such Affiliates  fails to rescind any and all of such actions, provided however that, nothing in this  clause prevents BP or its Affiliates from taking any of the actions referred to in this  clause and provided further that Pieris will not have the right to terminate if BP or  its Affiliates:   asserts invalidity as a defense in any court proceeding brought by  Pieris asserting infringement of one of the foregoing Patents;    acquires a Third Party that has an existing challenge, whether in a  court or administrative proceeding, against one of the foregoing Patents; or   licenses a product for which Pieris has an existing challenge,  whether in a court or administrative proceeding, against one of the  foregoing Patents.   Effects of Termination.   

 

[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.]    Execution Version  Page 67 of 94      GDSVF&H\6023374.4   Effects of Termination. In the event of any termination of this Agreement  in its entirety or with respect to any given Product or given country other than  termination (i) by BP for Pieris’ material breach under Section 13.2.1, (ii) by BP  due to Pieris’ insolvency under Section 13.2.4, or (iii) under Section 13.2.2  (termination by mutual agreement), then the following shall apply (in each case  solely to the extent relating to such Product(s) as each such Product exists (a) as of  the Effective Date and (b) at the time of termination (the “Terminated  Product(s)”) that are the subject of such termination):    At Pieris’ request, BP will return to Pieris or destroy (and certify  such destruction to Pieris), at Pieris’ option, all Pieris’ Confidential  Information related to the Terminated Product(s) and Pieris Know-How  related to the Terminated Product(s) (provided that BP shall be entitled to  retain one (1) copy for archival and compliance purposes, and as required  by Applicable Law or regulatory requirement). At BP’s request, subject to  Section 13.3.1.6, Pieris will return to BP or destroy (and certify such  destruction to BP), at BP’s option, all other BP Confidential Information  related to the Terminated Product(s) and all other BP Know-How related to  the Terminated Product(s) (provided that Pieris shall be entitled to retain  one (1) copy for archival and compliance purposes, and as required by  Applicable Law or regulatory requirement).   Pieris shall have the right to acquire some or all of the available  inventory of the Terminated Product, as requested by Pieris, in the  possession of BP and its Affiliates as of the date of such termination,  provided that, if Pieris so acquires any or all such inventory, Pieris shall  reimburse BP the cost incurred by BP for such inventory plus a [***]  percent ([***]%) mark-up and if Pieris does not purchase such inventory  BP shall be entitled to continue selling any such inventory for [***] months  following the effective date of termination; provided that the cause for  termination of BP was not due to a failure in such inventory being  Manufactured, stored and sold in compliance with cGMP and Applicable  Law. Any such inventory remaining following such [***] month period  shall be offered for sale to Pieris at a price equal to the cost incurred by BP  for such inventory plus a [***] percent ([***]%) mark-up.   All licenses and sublicenses granted by Pieris to BP with respect  to the Terminated Product(s) hereunder shall terminate, provided however  that they will continue solely to enable BP to (i) complete sales of the  Terminated Product(s) for any purchase orders that were in place prior to  the effective date of termination and (ii) sell off any existing inventory of  the Terminated Product(s) pursuant to Section 13.3.1.2; thereafter, BP will  discontinue Commercialization of the Terminated 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.]    Execution Version  Page 68 of 94      GDSVF&H\6023374.4   BP shall grant to Pieris a non-exclusive (sub)license under  Intellectual Property Rights Controlled by BP (subject to any and all  restrictions on BP and its Affiliates) to the extent reasonably necessary or  reasonable useful to Exploit the Terminated Product(s) solely to Exploit the  Terminated Product in the Field and in the Territory. Pieris shall be solely  responsible for paying any royalties, milestones or other sums which may  be due to Third Parties in respect of any Intellectual Property Rights  licensed by BP to Pieris pursuant to this Section 13.3.1.4 and for  reimbursing BP for its reasonable costs and expenses incurred in connection  with complying with this Section 13.3.1.4. Pieris shall take over  responsibility for the Prosecution and Maintenance and shall have sole  enforcement rights (with BP providing any reasonably requested assistance  at Pieris’ sole cost and expense) of any Patents in the Key IP that Cover the  Terminated Product.   At the request of Pieris, BP shall transition all ongoing Clinical  Studies and all ongoing Manufacturing campaigns with respect to the  Terminated Product(s) in a manner that permits Pieris to achieve  Completion of such Clinical Study and completion of such Manufacturing  campaign. Pieris shall be responsible for all costs associated with such  ongoing Clinical Studies and ongoing Manufacturing campaigns as of the  effective date of termination.    At the request of Pieris, BP shall use Commercially Reasonable  Efforts, at Pieris’ sole cost and expense, to: (i) transfer and assign to Pieris  or Pieris’ designee BP’s right, title and interest in and to all material  governmental or regulatory filings and approvals (including all Marketing  Approvals and pricing approvals, and Regulatory Materials, in all cases,  specifically and exclusively relating to the Development, Manufacture or  Commercialization of the Terminated Product(s) and (ii) transfer to Pieris  or Pieris’ designee copies of all material Data, Know-How, Clinical Study  data and safety data in BP’s possession and Control to the extent specifically  related to and required for the Research, Development, Manufacture or  Commercialization of such Terminated Product. In addition, at the request  of Pieris and at Pieris’ sole cost and expense, BP will appoint Pieris as BP’s  and/or BP’s Affiliates’ agent for all Terminated Product-related matters  involving Regulatory Authorities until all Marketing Approvals, regulatory  approvals and other regulatory filings hereunder have been assigned to  Pieris or its designee. In the event of (x) failure to obtain assignment or (y)  with respect to regulatory items that would otherwise fall within (i) and (ii)  but for such materials not being specifically related to the relevant  Product(s) but nonetheless which are reasonably necessary for the  

 

[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.]    Execution Version  Page 69 of 94      GDSVF&H\6023374.4  Development, Manufacture or Commercialization of such Terminated  Product, in each of (x) and (y) BP hereby consents and grants to Pieris the  right to access and reference (without any further action required on the part  of BP, whose authorization to file this consent with any Regulatory  Authority is hereby granted) any such item with respect to such Terminated  Product.   If BP or its Affiliates are Manufacturing the Terminated  Product(s) on the effective date of termination, at Pieris’ option and upon  Pieris’ request, BP or its Affiliates will use Commercially Reasonable  Efforts to supply such Terminated Product to Pieris at BP’s Fully Burdened  Manufacturing Cost plus [***] percent ([***]%), until the earlier of (i) such  time as Pieris has procured or developed its own source of such Terminated  Product supply, or (ii) [***] months following the effective date of  termination.  Should Pieris not be able to procure or develop its own source  of Product supply within [***] months, then the Parties will discuss in good  faith a potential extension of supply by BP to avoid any supply interruption.  The Parties will promptly negotiate a supply and related quality agreement  to govern the specific terms and conditions of such supply.     If Pieris so requests in writing within [***] days of the effective  date of termination, the Parties will cooperate (with BP using Commercially  Reasonable Efforts), to the extent legally permissible (including to the  extent permitted under BP’s obligations to Third Parties on the effective  date of termination), to assign to Pieris any Third Party agreements that are  specific to and exclusively relating to the Development, Manufacture or  Commercialization of the Terminated Product(s) to which BP is a party,  subject to any required consents of such Third Party.   Upon Pieris’ request and at Pieris’ sole cost and expense, BP shall  promptly transfer and assign or license (or, if applicable, will cause its  Affiliates to assign or license) to Pieris all of BP’s (and such Affiliates’)  worldwide right, title and interest in and to any registered trademarks or  registered internet domain names that are specific to the Terminated Product  (it being understood that the foregoing will not include any trademarks or  internet domain names that contain the corporate or business name(s) of BP  or any of its Affiliates or any other product of BP or any of its Affiliates).   BP shall cooperate in good faith and use Commercially  Reasonable Efforts for a reasonable time not to exceed [***] months to  ensure a smooth and orderly transition of the Terminated Product, including  any Development, Manufacturing, or Commercialization activities ongoing  at the time of termination to Pieris, and negotiating reasonably and in good  

 

[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.]    Execution Version  Page 70 of 94      GDSVF&H\6023374.4  faith the terms and conditions of any further agreements or the signature of  documents consistent with this Section 13.3.1.    For Material Breach or Insolvency. In the event that BP terminates this  Agreement in its entirety or with respect to any given Terminated Product as a result  of Pieris’ material breach under Section 13.2.1 or due to Pieris’ insolvency under  Section 13.2.4, then the following terms shall apply (in each case solely to the  extent relating to such Terminated Product(s) that are the subject of such  termination):   At the Disclosing Party's request, the Receiving Party will return  to the Disclosing Party or destroy (and certify such destruction to the  Disclosing Party), at Disclosing Party’s option and sole cost and expense,  all Disclosing Party’s Confidential Information related to such Terminated  Product(s) (provided that the Receiving Party shall be entitled to retain one  (1) copy for archival and compliance purposes, and as required by  Applicable Law or regulatory requirement).   All Development, Manufacture and Commercialization of the  Terminated Product(s) by the Parties shall immediately cease;   The licenses granted by Pieris to BP with respect to the  Terminated Product(s) shall immediately terminate; and   The non-compete set forth in Section 7.2 regarding the Terminated  Product will no longer apply.   Rights in Bankruptcy. All rights and licenses granted under or pursuant to  this Agreement are, and shall otherwise be deemed to be, for all purposes of Section  365(n) of the United States Bankruptcy Code and of any similar or analogous  provisions of Applicable Law outside of the United States (the “Bankruptcy  Code”), licenses and rights to “intellectual property” as defined under Section  101(35A) of the U.S. Bankruptcy Code. Pieris agrees that BP, as licensee of such  rights under this Agreement, shall retain and may fully exercise all of its rights and  elections under the Bankruptcy Code. In the event of the commencement of a  bankruptcy proceeding by or against Pieris under the Bankruptcy Code (the  “Insolvent Party”), BP shall be entitled to a complete duplicate of (or complete  access to, as appropriate) any intellectual property and Know-How licensed to BP  under this Agreement and held by Pieris and its successors and assigns (and all  embodiments of such intellectual property and Know-How), provided that, a Party  shall not be required to provide any duplicate copies and embodiments of such  intellectual property or  Know-How to the other Party so long it has already  provided such intellectual property and Know-How it is required to provide to  

 

[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.]    Execution Version  Page 71 of 94      GDSVF&H\6023374.4  under this Agreement, and, if not already in its possession, shall be promptly  delivered to it (a) upon any such commencement of a bankruptcy proceeding upon  its written request therefore, unless the Insolvent Party continues to perform all of  its obligations under this Agreement, or (b) if not delivered or granted under (a)  above, following the rejection of this Agreement by or on behalf of the Insolvent  Party upon written request therefore by the other Party.     Survival. The termination or expiration of this Agreement shall not affect  any payment of any debts or obligations accruing prior to or after such date of  termination or expiration. The provisions of Section 1 (to the extent necessary to  give effect to the surviving provisions), Section 8 (with respect to any payments  due but not yet received and any Net Sales accrued following the Term during a  permitted sell-off period under Section 13.3.1.2), Section 8.8.2 (for any final reports  and final payments), Section 8.8.3, Section 10.1 (except for the last sentence of  Section 10.1.2), Section 12, Section 13 (until completion of termination  obligations) and Section 14 will survive the expiration or any termination of this  Agreement for any reason, in accordance with their respective terms and conditions,  and for the respective duration stated therein, and where no duration is stated, will  survive indefinitely. In addition, any Section that is referred to in the above listed  Sections shall survive solely for the interpretation or enforcement of the above  listed Sections.  14. MISCELLANEOUS   Dispute Resolution.    Resolution by Senior Representatives. The Parties will seek to settle  amicably any and all disputes, controversies or claims arising out of or in  connection with this Agreement (a “Dispute”). Any Dispute between the Parties  will be promptly presented to the Senior Representatives for resolution. Such  Senior Representatives will meet in person or by teleconference as soon as  reasonably possible thereafter, and use their good faith efforts to mutually agree  upon the resolution of the Dispute.   Escalation to Senior Executives. Either Party may, by written notice to the  other Party, request that a Dispute that remains unresolved by the Senior  Representatives for a period of [***] days as set forth in Section 14.1.1, be resolved  by the Senior Executives, within [***] days after referral of such Dispute to them.  If the Senior Executives cannot resolve such Dispute within [***] days after referral  of such Dispute to them, then, at any time after such [***] day period, either Party  may proceed to enforce any and all of its rights with respect to such Dispute in  accordance with this Section 14.1.  

 

[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.]    Execution Version  Page 72 of 94      GDSVF&H\6023374.4   Request for Arbitration. Upon completion of its obligations under Section  14.1.1 and Section 14.1.2 and subject to Section 14.1.5 and Section 14.2.2, either  Party may upon written notice to the other submit the Dispute to binding arbitration  pursuant to Section 14.1.4.1 below. No statements made by either Party during such  discussions will be used by the other Party or admissible in arbitration or any other  subsequent proceeding for resolving the Dispute.   Arbitration.   Subject to Section 14.1 and Section 14.2, any Dispute (including  any dispute, claim or controversy arising from or related in any way to this  Agreement or the interpretation, application, breach, termination or validity  thereof, including any claim of inducement of this Agreement by fraud or  otherwise, not resolved under the provisions of Section 14.1.1 or Section  14.1.2), will be resolved by final and binding arbitration conducted in  accordance with the terms of this Section 14.1.4.1. The arbitration will be  held in New York, New York, USA according to the CPR Non- Administered International Arbitration Rules in effect on the date of this  Agreement (“Rules”). The arbitration will be conducted by a panel of three  (3) arbitrators with significant experience in the pharmaceutical industry,  unless otherwise agreed by the Parties, appointed in accordance with  applicable Rules. Any arbitration herewith will be conducted in the English  language to the maximum extent possible. The arbitrators will render a  written decision no later than [***] months following the selection of the  arbitrators, including a basis for any damages awarded and a statement of  how the damages were calculated. Any award will be promptly paid in U.S.  dollars free of any tax, deduction or offset. Each Party agrees to abide by  the award rendered in any arbitration conducted pursuant to this Section  14.1.4.1. With respect to money damages, nothing contained herein will be  construed to permit the arbitrator or any court or any other forum to award  punitive or exemplary damages, except in the case of breach of Section 10.1.  By entering into this agreement to arbitrate, the Parties expressly waive any  claim for punitive or exemplary damages, except in the case of breach of  Section 10.1. Each Party will pay its legal fees and costs related to the  arbitration (including witness and expert fees). Judgment on the award so  rendered will be final and may be entered in any court having jurisdiction  thereof.   EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF  ANY ISSUE BY JURY. EACH PARTY HERETO WAIVES ANY CLAIM  FOR ATTORNEYS' FEES AND COSTS AND PREJUDGMENT  INTEREST FROM THE OTHER.  

 

[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.]    Execution Version  Page 73 of 94      GDSVF&H\6023374.4   Court Actions. Nothing contained in this Agreement will deny either Party  the right to seek injunctive or other equitable relief from a court of competent  jurisdiction in the context of a bona fide emergency or prospective irreparable harm,  and such an action may be filed and maintained notwithstanding any ongoing  Dispute resolution discussions or arbitration proceeding. In addition, either Party  may bring an action in any court of competent jurisdiction to resolve Disputes  pertaining to the validity, construction, scope, enforceability, infringement or other  violations of patents or other proprietary or Intellectual Property Rights, and no  such claim will be subject to arbitration pursuant to Section 14.1.4.1.   Governing Law, Jurisdiction, Equitable Relief, Losses, and Remedies.   This Agreement will be governed by and construed and enforced in  accordance with the laws of the State of New York, USA, without reference to any  rules of conflicts of laws. For clarification, any Dispute relating to the scope,  validity, enforceability or infringement of any Patents will be governed by and  construed and enforced in accordance with the patent laws of the applicable  jurisdiction.    Each Party acknowledges and agrees that the restrictions set forth in Section  7.2 of this Agreement are reasonable and necessary to protect the legitimate  interests of the other Party and that the other Party would not have entered into this  Agreement in the absence of such restrictions, and that any breach or threatened  breach of any of these provisions will probably result in irreparable injury to the  other Party for which there will be no adequate remedy at law. In the event of a  breach or threatened breach of any such provision, each Party will be authorized  and entitled to obtain from any court of competent jurisdiction equitable relief,  whether preliminary or permanent, specific performance and an equitable  accounting of all earnings, profits and other benefits arising from such breach,  which rights will be cumulative and in addition to any other rights or remedies to  which such Party may be entitled in law or equity. Each Party agrees to waive any  requirement that the other Party (a) post a bond or other security as a condition for  obtaining any such relief, and (b) show irreparable harm, balancing of harms,  consideration of the public interest or inadequacy of monetary damages as a  remedy. Nothing in this Section 14.2.2 is intended, or should be construed, to limit  a Party's rights to equitable relief or any other remedy for a breach of any other  provision of this Agreement. Except for (i) any amount awarded to be paid by one  Party to the other by the panel of arbitrators in a final and binding arbitration  proceeding adjudicated under Section 14.1.4.1, and (ii) any offset of undisputed but  unpaid amounts under this Agreement, neither Party will have the right to set off  any amount it is owed or believes it is owed against payments due or payable to the  other Party 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.]    Execution Version  Page 74 of 94      GDSVF&H\6023374.4   Neither Party will be entitled to recover any Losses relating to any matter  arising under one provision of this Agreement to the extent that such Party has  already recovered Losses with respect to such matter pursuant to other provisions  of this Agreement (including recoveries under Section 12).   Assignments and Successors. Neither this Agreement nor any obligation of a Party  hereunder may be assigned by either Party without the consent of the other, except that  each Party may assign this Agreement and the rights, obligations and interests of such  Party, in whole or in part, without the other Party’s consent, to any of its Affiliates for as  long as such entity remains an Affiliate, to any purchaser of all or substantially all of its  assets to which this Agreement or relevant part relates or to any successor corporation  resulting from any merger, consolidation, share exchange or other similar transaction. In  addition, Pieris may assign or transfer its rights to receive payments under this Agreement  (but no liabilities) with BP’s consent (not to be unreasonably withheld, conditioned or  delayed) to an Affiliate or to a Third Party in connection with a payment factoring  transaction. Upon execution of such agreement and upon Pieris’ request, BP shall provide  royalty reports described under Section 8.8.2 and direct payments to such Third Party of  specified amounts otherwise due to Pieris and such provision and direction shall satisfy  any obligation to provide such a payment or report to Pieris. Any purported assignment or  transfer made in contravention of this Section 14.3 will be null and void. This Agreement  shall be binding upon the successors and permitted assigns of the Parties.    Acquiror IP. Notwithstanding anything to the contrary in this Agreement, in the  event of a Change of Control involving either Party or its business after the Effective Date  (the Third Party acquiring such Party or its business being the “Acquiror”), whether by  merger, asset purchase or otherwise, as to any such Acquiror, the non-acquired Party shall  not obtain rights, licenses, options or access to any Intellectual Property Rights or Know- How, product candidates or Product that are held by the Acquiror or any Affiliate of the  Acquiror that becomes an Affiliate of the acquired Party as a result of such acquisition (but  excluding the acquired Party itself), that were not generated through any use or access to  the Intellectual Property Rights or Know-How of the acquired Party, or that are not used  by the acquired Party in connection with a Product under this Agreement.    Change of Control.    Notice. Each Party will provide written notice (“COC Notice”) to the other  Party within [***] days following the closing of a Change of Control involving  such Party, and such notice will identify the Third Party acquiring company (the  “COC Acquiror”).    Competing Products in a Change of Control. In the event that Pieris is subject  to a Change of Control and the entity that acquires Pieris has a Competing Product,  Pieris shall include in its COC Notice provided to BP under Section 14.5.1  

 

[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.]    Execution Version  Page 75 of 94      GDSVF&H\6023374.4  information regarding whether such COC Acquiror has a Competing Product that  would otherwise violate Section 7.2. In such event, then such COC Acquiror and  Pieris may commit to a divestiture of such Competing Product in connection with  such Change in Control where they have no operational role in the development or  commercialization of the Competing Product and shall be considered in compliance  with Section 7.2 notwithstanding any provisions to the contrary. In the event of a  Change of Control that involves an acquisition of Pieris and where the COC  Acquiror has a Competing Product and does not commit to a divestiture of such  Competing Product, then upon BP’s written election after receipt of such COC  Notice from Pieris (such election (“BP COC Election Notice”) shall be made in  writing to Pieris no later than [***] Business Days after receipt of the COC Notice  from Pieris), and effective as of the closing date of such Change of Control:   BP shall not be obligated to share any further updates to the  Development Plan to Pieris;    Except as provided below, Pieris shall have no further right of  input or insight into BP’s Exploitation of the Products hereunder;   BP shall have no further reporting obligations hereunder with  respect to the Exploitation of, and regulatory activities for, the Products  other than its financial reporting and record-keeping obligations, and audit  rights, to the extent necessary to verify the accuracy of the calculation of  the royalties or milestones paid or payable to Pieris;    Pieris’ right to a right of first negotiation under Section 2.4 shall  terminate;    BP shall have no further obligation to disclose to Pieris any BP  Know-How developed or reduced to practice after the closing date of the  Change of Control; and    Pieris shall put in place a “firewall” of reasonable safeguards  between individuals with access to Pieris Product Know-How and BP  Confidential Information, on the one hand, and the personnel responsible  for the Exploitation of such Competing Product, on the other hand, such that  the Exploitation of such Competing Product does not make use of or  incorporate any technology Covered by Pieris IP, Key IP, BP Confidential  Information or BP Patents; and   For avoidance of doubt, except as set forth in this Section 14.5, the Parties’  rights and obligations under this Agreement shall remain in effect in the event of a  Change of Control or an assignment 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.]    Execution Version  Page 76 of 94      GDSVF&H\6023374.4   Force Majeure. No Party will be held responsible to the other Party nor be deemed  to be in default under, or in breach of any provision of, this Agreement for failure or delay  in performing any obligation of this Agreement when such failure or delay is due to force  majeure, and without the fault or negligence of the Party so failing or delaying. For  purposes of this Agreement, force majeure means a cause beyond the reasonable control of  a Party, which may include acts of God; acts, regulations, or laws of any government; war;  terrorism; civil commotion; fire, flood, earthquake, tornado, tsunami, explosion or storm;  pandemic; epidemic and failure of public utilities or common carriers. In such event the  Party so failing or delaying will immediately notify the other Party of such inability and of  the period for which such inability is expected to continue. The Party giving such notice  will be excused from such of its obligations under this Agreement as it is thereby disabled  from performing for so long as it is so disabled for up to a maximum of [***] days, after  which time the Parties will negotiate in good faith any modifications of the terms of this  Agreement that may be necessary to arrive at an equitable solution, unless the Party giving  such notice has set out a reasonable timeframe and plan to resolve the effects of such force  majeure and executes such plan within such timeframe. To the extent possible, each Party  will use reasonable efforts to minimize the duration of any force majeure.    Notices. Any notice, request, approval or consent required or permitted to be given  under or in connection with this Agreement shall be in writing, in English, effective only  upon receipt and will be deemed to have been sufficiently given if personally delivered,  sent by internationally recognized overnight express courier service (prepaid with signature  required), or by email (receipt verified), to the Party for which such notice is intended, at  the address set forth for such Party below:     If to Pieris, addressed to:  Pieris Pharmaceuticals GmbH  Attention: Alliance Manager  Zeppelinstraße 3  85399 Hallbergmoos, Germany    With a copy to:     Pieris Pharmaceuticals, Inc.  Attention: [***]  255 State Street, 9th Floor  Boston, MA 02109  [***]    If to BP, addressed to:   BP Asset XII, Inc.        Attention: [***]  55 Cambridge Parkway, Suite 400        Cambridge, MA 02142        [***]  

 

[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.]    Execution Version  Page 77 of 94      GDSVF&H\6023374.4    With a copy to:  Gunderson Dettmer Stough Villeneuve Franklin &  Hachigian LLP        Attention: [***]  One Marina Park Drive, Suite 900         Boston, MA 02210         [***]    or to such other address for such Party as it will have specified by like notice to the other  Party. It is understood and agreed that this Section 14.7 is not intended to govern the day  to day business communications necessary between the parties in performing their duties,  in due course, under the terms of this Agreement.   Export Clause. Each Party acknowledges that the laws and regulations of the United  States and other countries may restrict the export and re-export of commodities and  technical data of United States or such foreign country origin. Each Party agrees that it will  not export or re-export restricted commodities or the technical data of the other Party in  any form without the appropriate United States and/or foreign government licenses.   Waiver. Neither Party may waive or release any of its rights or interests in this  Agreement except in writing. The failure of either Party to assert a right hereunder or to  insist upon compliance with any term or condition of this Agreement will not constitute a  waiver of that right or excuse a similar subsequent failure to perform any such term or  condition. No waiver by either Party of any condition or term in any one or more instances  will be construed as a continuing waiver or subsequent waiver of such condition or term or  of another condition or term.   Severability. If any provision of this Agreement is held to be illegal, invalid or  unenforceable by a court of competent jurisdiction, such adjudication will not affect or  impair, in whole or in part, the validity, enforceability, or legality of any remaining portions  of this Agreement. All remaining portions will remain in full force and effect as if the  original Agreement had been executed without the invalidated, unenforceable or illegal  part. The Parties shall make a good faith effort to replace the invalid or unenforceable  provision with a valid one which in its economic effect is most consistent with the invalid  or unenforceable provision.   Entire Agreement; Modifications. This Agreement (including exhibits) sets forth  and constitutes the entire agreement and understanding between the Parties with respect to  the subject matter hereof, and all prior agreements, including prior rights and obligations  with respect to Confidential Information exchanged under prior confidentiality agreements,  understandings, promises and representations, whether written or oral, with respect thereto  are superseded hereby. Each Party confirms that it is not relying on any representations or  warranties of the other Party except as specifically set forth herein. No amendment,  

 

[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.]    Execution Version  Page 78 of 94      GDSVF&H\6023374.4  modification, release or discharge will be binding upon the Parties unless in writing and  duly executed by authorized representatives of both Parties.   Relationship of the Parties. It is expressly agreed that the Parties will be  independent contractors of one another and that the relationship between the Parties will  not constitute a partnership, joint venture or agency.   Interpretation. Except as otherwise explicitly specified to the contrary, (a)  references to an article, section, appendix, exhibit or schedule means an article, section of,  or appendix, schedule or exhibit to this Agreement, unless another agreement is specified,  (b) the word “including” (in its various forms) means “including without limitation,” (c)  the words “will” and “shall” have the same meaning, (d) references to a particular statute  or regulation include all rules and regulations thereunder and any predecessor or successor  statute, rules or regulation, in each case as amended or otherwise modified from time to  time, (e) references to a particular Person include such Person’s successors and assigns to  the extent not prohibited by this Agreement, (f) unless otherwise specified, “$” is in  reference to United States dollars, (g) the headings contained in this Agreement, in any  exhibit or schedule to this Agreement and in the table of contents to this Agreement are for  convenience only and will not in any way affect the construction of or be taken into  consideration in interpreting this Agreement; and (h) or the context otherwise requires, the  word “or” is used in the inclusive sense (and/or).   Books and Records. Any books and records to be maintained under this Agreement  by a Party or its Affiliates or Sublicensees will be maintained in accordance with generally  accepted accounting principles, or in the case of non-United States sales, other applicable  Accounting Standards, consistently applied.   Construction of Agreement. The terms and provisions of this Agreement represent  the results of negotiations between the Parties and their representatives, each of which has  been represented by counsel of its own choosing, and neither of which has acted under  duress or compulsion, whether legal, economic or otherwise. Accordingly, the terms and  provisions of this Agreement will be interpreted and construed in accordance with their  usual and customary meanings, and each of the Parties hereto hereby waives the application  in connection with the interpretation and construction of this Agreement of any rule of law  to the effect that ambiguous or conflicting terms or provisions contained in this Agreement  will be interpreted or construed against the Party whose attorney prepared the executed  draft or any earlier draft of this Agreement.   Supremacy. In the event of any express conflict or inconsistency between this  Agreement and any Schedule, Exhibit or Appendix hereto, the terms of this Agreement  will apply to the extent of such conflict or inconsistency. The Parties understand and agree  that the Schedules and Appendices hereto are not intended to be the final and complete  embodiment of any terms or provisions of this Agreement, and are to be updated from time  

 

[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.]    Execution Version  Page 79 of 94      GDSVF&H\6023374.4  to time during the Term, as appropriate and in accordance with the provisions of this  Agreement.   Counterparts. This Agreement may be signed in counterparts, each of which will  be deemed an original, notwithstanding variations in format or file designation which may  result from the electronic transmission, storage and printing of copies of this Agreement  from separate computers or printers. Signatures transmitted via electronic mail in PDF  format will be treated as original signatures.    Compliance with Laws. Each Party will, and will ensure that its Affiliates and  Sublicensees will, comply in all material respects with the relevant laws (including all  Applicable Law) and regulations in exercising its rights and fulfilling its obligations under  this Agreement in each case as applicable under the laws and regulations of the country  and the state and local government wherein such activities are conducted.    [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.]    Execution Version  Page 80 of 94      GDSVF&H\6023374.4    IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their  representatives thereunto duly authorized as of the Effective Date.      Pieris Pharmaceuticals, Inc.    Pieris Pharmaceuticals GmbH       By:  /s/ Stephen S. Yoder     By:  /s/ Stephen S. Yoder        Name: Stephen S. Yoder     Name: Stephen S. Yoder  Title: President & CEO        Title: Managing Director   Date: April 24, 2021      Date: April 24, 2021      BP Asset XII, Inc. Acknowledged and agreed by Boston Pharma  Holdings, LLC (solely for the purposes of Section  12.5.1 and Section 12.5.3)      By:  /s/ Rob Armstrong     By:  /s/ Rob Armstrong       Name: Rob Armstrong     Name: Rob Armstrong  Title: President & CEO      Title: President and CEO    Date: April 24th, 2021      Date: April 24th, 2021      Acknowledged and agreed by Boston Pharmaceuticals, Inc. (solely for the purposes of  Section 12.5.2 and Section 12.5.4)      By:  /s/ Rob Armstrong         Name: Rob Armstrong  Title: President and CEO   Date: April 24th, 2021         

 

[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.]    Execution Version  Page 81 of 94      GDSVF&H\6023374.4  Exhibit Index      Exhibit 1.21: Arising Patents    Exhibit 1.128: Pieris Building Block Patents    Exhibit 1.134: Pieris Patents    Exhibit 1.138: Pieris Platform Patents    Exhibit 1.142: Pieris Product Patents    Exhibit 1.144: Product Sequence    Exhibit 2.3.2: Pieris Approved Subcontractors    Exhibit 4.1: Initial Product Development Plan    Exhibit 4.3.2: Technology Transfer Plan    Exhibit 8.6.2: Initial Product Sequence      Exhibit 10.3.1: Initial Press Release         

 

[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.]    Execution Version  Page 82 of 94      GDSVF&H\6023374.4  Exhibit 1.21: Arising Patents       

 

[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.]    Execution Version  Page 83 of 94      GDSVF&H\6023374.4  Exhibit 1.128: Pieris Building Block Patents    [***]   

 

[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.]    Execution Version  Page 84 of 94      GDSVF&H\6023374.4  Exhibit 1.134: Pieris Patents    [***]     

 

[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.]    Execution Version  Page 85 of 94      GDSVF&H\6023374.4  Exhibit 1.138: Pieris Platform Patents    [***]     

 

[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.]    Execution Version  Page 86 of 94      GDSVF&H\6023374.4  Exhibit 1.142: Pieris Product Patents    [***]   

 

[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.]    Execution Version  Page 87 of 94      GDSVF&H\6023374.4  Exhibit 1.144: Product Sequence    [***]     

 

[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.]    Execution Version  Page 88 of 94      GDSVF&H\6023374.4  Exhibit 2.3.2: Pieris Approved Subcontractors    [***]   

 

[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.]    Execution Version  Page 89 of 94      GDSVF&H\6023374.4  Exhibit 4.1: Initial Product Development Plan    [***]     

 

[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.]    Execution Version  Page 90 of 94      GDSVF&H\6023374.4  Exhibit 4.3.2: Technology Transfer Plan      [***]    

 

EXHIBIT 10.1    [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.]    Execution Version        Exhibit 8.6.2: Initial Product Sequence    [***]     

 

[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.]    Execution Version  Page 92 of 94      GDSVF&H\6023374.4  Exhibit 10.3.1: Initial Press Release         PRESS RELEASE  Pieris Pharmaceuticals and Boston Pharmaceuticals Enter into an Exclusive Worldwide  Product License for PRS-342, a 4-1BB/GPC3 Immuno-Oncology Bispecific  • Pieris will receive $10 million upfront and be entitled to receive additional  milestone payments and tiered royalties  • Boston Pharmaceuticals will be primarily responsible for development of the  program, with both parties collaborating during the investigational new drug  (IND)-enabling stage  BOSTON and CAMBRIDGE, Mass., April 26, 2021 - Pieris Pharmaceuticals, Inc. (NASDAQ:  PIRS) and Boston Pharmaceuticals today announced that the companies have entered into an  exclusive product license agreement to develop PRS-342, a 4-1BB/GPC3 preclinical immuno- oncology Anticalin®-antibody bispecific fusion protein. Under the terms of the agreement,  Boston Pharmaceuticals has exclusively licensed worldwide rights to PRS-342. Pieris will  receive an upfront payment of $10 million and is further entitled to receive up to approximately  $353 million in development, regulatory, and sales-based milestone payments, and tiered  royalties on sales of PRS-342. Pieris will also contribute an undisclosed amount toward  manufacturing activities.  “Based on the encouraging preclinical data from PRS-342, as well as data demonstrative of the  4-1BB mechanism of action we have seen from Pieris’ other immuno-oncology programs, we  are excited to have the opportunity on a global scale to progress this program into clinical  development in areas of significant unmet need,” said Robert Armstrong, Chief Executive  Officer of Boston Pharmaceuticals. “We look forward to working with Pieris, benefiting from both  their strong early-stage development expertise and their deep understanding of immuno- oncology bispecifics.”  “Our recent presentations at AACR for our HER2- and PD-L1-targeting 4-1BB bispecifics  demonstrate the potency of our costimulatory approach, especially our bispecific antibodies’  ability to achieve clinical benefit, including in patients who have failed checkpoint therapy. It is  therefore rewarding to see another one of our 4-1BB-based Anticalin bispecifics for immuno- oncology moving towards the clinic,” said Stephen S. Yoder, President and Chief Executive  Officer of Pieris. “Boston Pharmaceuticals has a strong leadership team and proven track record  of developing a broad range of assets, including in oncology, and we look forward to the  advancement of this next-generation bispecific and to directly supporting some crucial next  steps towards clinical initiation.”  About Pieris Pharmaceuticals:  

 

[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.]    Execution Version  Page 93 of 94      GDSVF&H\6023374.4  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.  About Boston Pharmaceuticals:  Boston Pharmaceuticals is a clinical stage biopharmaceutical company that leverages an  experienced drug development team to advance a portfolio of high value candidates that  address important unmet medical needs. The Company partners with innovative biotechnology  and pharmaceutical companies to acquire drug development candidates. We adhere to a  rigorous decision-making process, follow the data, and advance only those programs that meet  our stringent development hurdles. We look to establish value creating partnerships with the  world’s leading biotechnology and pharmaceutical companies that help advance programs to  commercial stage. We are continuously seeking new opportunities to leverage our model to  create a path to value for our patients and partners. Boston Pharmaceuticals is a portfolio  company of Waypoint Capital, an investment firm based in Europe and focused on healthcare,  medical technologies, and asset management. For more information, please visit  www.bostonpharmaceuticals.com or follow us on Twitter @BosPharma and LinkedIn.  Forward-Looking Statements:  This press release contains forward-looking statements as that term is defined in Section 27A of  the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements  in this press release that are not purely historical are forward-looking statements. Such forward- looking statements include, among other things, 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  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; 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  

 

[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.]    Execution Version  Page 94 of 94      GDSVF&H\6023374.4  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 herein and should also refer to the risk factor disclosure set forth in the  reports and other documents we file with the SEC 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.      Contacts:             Pieris Pharmaceuticals, Inc.    Maria Kelman    Executive Director, Investor Relations    +1 857 362 9635    kelman@pieris.com                 Boston Pharmaceuticals  Susan Sharpe or Emily Wong  MacDougall  +1 781 235 3060  bostonpharmaceuticals@macbiocom.compieris-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

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