Document:

exhibit103eversana-msa

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.                                                                    EXECUTION COPY                           MASTER SERVICES AGREEMENT   This Master Services Agreement (the “Agreement”) is made on August 6, 2020 (the “Effective  Date”) by and between Zosano Pharma Corporation, with a place of business at 34790  Ardentech Court, Fremont, California 94555  (“Zosano”); and Eversana Life Science Services,  LLC, with a place of business at 190 N. Milwaukee Street, Milwaukee, WI 53202 (“Eversana”).  Zosano and Eversana are hereinafter referred to individually as a “Party” and collectively as the  “Parties”.                                   BACKGROUND   Whereas, Zosano is a pharmaceutical company that is developing the Product (as defined below)  to treat migraines;   Whereas, Eversana is a life sciences services company that has experience supervising and  managing sales teams that provide marketing and promotional services related to pharmaceutical  products; and   Whereas, Zosano wishes to engage Eversana to supervise and manage the day to day  Commercialization of the Product in the Territory (as defined below) under the terms and  conditions set forth herein.   NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below,  and other consideration received by the Parties, the Parties hereby agree as follows:   1.  DEFINITIONS   For the purposes of this Agreement, the following words and expressions shall have the stated  definitions:   1.1. “Act” means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), as      amended from time to time, together with any rules, regulations, guidances, guidelines and      requirements of the FDA as may be in effect from time to time.   1.2. “Adverse Event” means the development of an undesirable medical condition or the      deterioration of a pre-existing medical condition following or during exposure to the Product,      whether or not considered causally related to the Product, the exacerbation of any pre-     existing condition(s) occurring following or during the use of the Product or any other      adverse event, adverse experience, adverse drug experience, life-threatening adverse drug      experience, serious adverse drug experience, or unexpected adverse drug experience as      defined and/or as described in the FDA’s Investigational New Drug safety reporting and      post-marketing reporting regulations, 21 C.F.R. § 312.32 and § 314.80, respectively, as they      may be amended from time to time. For purposes of this Agreement, without limiting the      forgoing, “undesirable or unexpected medical condition” includes symptoms (e.g., nausea,      chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an      investigation (e.g., laboratory findings, electrocardiogram), including without limitation      unfavorable side effects, toxicity, injury, overdose, sensitivity reactions or failure of the      Product to exhibit its expected pharmacologic/biologic effect.  

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      1.3. “Affiliate” means any entity that is, directly or indirectly, controlled by, under common control       with, or in control of a party, where “control” means power to elect or appoint a majority of       directors or to direct the management of an entity.    1.4. “Anti-Corruption Laws” means the Foreign Corrupt Practices Act of 1977, as amended,       the UK Bribery Act 2010, the Anti-Kickback Statute, the False Claims Act, the Department       of Health and Human Services Office of Inspector General Compliance Program Guidance       for Pharmaceutical Manufacturers, released April 2003, the Antifraud and Abuse       Amendment to the Social Security Act, and any other applicable law, rule, regulation or       industry code governing anti-bribery and anti-corruption laws and laws for the prevention of       kickbacks, fraud, abuse, racketeering, money laundering or terrorism.     1.5. “Applicable Law” means (a) all applicable laws, rules and regulations, including without       limitation any applicable rules, regulations, guidelines or other requirements of       Governmental Authorities that may be in effect in the Territory from time to time during the       Term, including without limitation (i) the Act, (ii) the PDMA, (iii) Anti-Corruption Laws, (iv) all       federal, state or local statutes, laws, ordinances, regulations or guidelines relating to       employment, safety and health of employees and the withholding and payment of required       taxes with respect to employees, and (v) all federal, state or local statutes, laws, ordinances,       regulations or guidelines relating to data protection and privacy, including without limitation       the United States Department of Health and Human Services privacy rules under the Health       Insurance Portability and Accountability Act and the Health Information Technology for       Economic and Clinical Health Act and (b) the PhRMA Code on Interactions with Healthcare       Professionals.   1.6. “Arising Product IP” means all Know-How and other Intellectual Property Rights relating       to the Product arising out of or in connection with either Party’s or their respective Affiliates’       activities under or in connection with this Agreement. Arising Product IP excludes any       Eversana IP or any Zosano IP.   1.7. “Business Day” means a day on which companies in the United States are generally open       for business.   1.8. “Change of Control” means (a) the closing of a merger, consolidation, liquidation or       reorganization of Zosano into or with another company or other legal person, after which       merger, consolidation, liquidation or reorganization the capital stock of Zosano outstanding       prior to consummation of the transaction is not converted into or exchanged for or does not       represent more than 50% of the aggregate voting power of the surviving or resulting entity;       (b) the direct or indirect acquisition by any person (as the term “person” is used in Section       13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended) of more than 50%       of the voting capital stock of Zosano, in a single or series of related transactions; or (c) the       sale, exchange, or transfer of all or substantially all of the assets of Zosano to which this       Agreement pertains (other than a sale, exchange, or transfer to one or more entities where       the stockholders of the Company immediately before such sale, exchange or transfer retain,       directly or indirectly, at least a majority of the beneficial interest in the voting stock of the       entities to which the assets were transferred).    1.9. “Commercial Launch” is the date of first commercial sale of the Product to a Customer in       the Territory.                                          2   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      1.10. “Commercial Services” means the services set forth in Exhibit B.    1.11. “Commercialization,” “Commercialize” and “Commercializing” mean any and all       customary processes and activities undertaken by a pharmaceutical company to       accomplish the commercialization of a pharmaceutical product, including without limitation       with respect to the Product, the storage, distribution, sales activities, promotion and       marketing of the Product and managing returns of the Product, the conduct of Patient       Access Programs, Patient Assistance Programs, and reimbursement activities, but       expressly exclude activities related to development or clinical testing of the Product or       Manufacturing of the Product, and expressly excludes, as to Eversana, booking sales of the       Product. For clarity, all product sales shall be booked by, and in the name of, Zosano.      1.12. “Commercialization Budget” means the budget for Commercializing the Product as       approved by the Joint Management Committee, as such budget may be amended by the       Joint Management Committee from time to time.     1.13. “Commercialization Fees” shall have the meaning set forth in Section 5.4.    1.14. “Commercialization Plan” means the plan for Commercializing the Product as approved       by the Joint Management Committee, as such plan may be amended by the Joint       Management Committee from time to time.    1.15. “Commercially Reasonable Efforts” means the efforts and resources which would be       used (including the promptness in which such efforts and resources would be applied) by a       similarly situated Party conducting similar activities for products of similar nature, consistent       with generally accepted industry standards with regard to the activity to be undertaken.     1.16. “Competing Product” means a product with an indication approved by FDA for the [***].    1.17. “Confidential Information” means all business, operational, marketing, financial, technical,       manufacturing, scientific, or other information that is confidential or proprietary to a Party,       or an Affiliate of a Party, provided by or on behalf of such Party or its Affiliate to the other       Party pursuant to this Agreement and not generally known to the public. Confidential       Information includes Manufacturing Data (which shall be deemed Confidential Information       disclosed by Zosano) and this Agreement (and the terms hereof, which collectively shall be       deemed Confidential Information disclosed by each Party). Confidential Information of the       disclosing Party may include processes and methods, process specifications and designs,       inventions, Know-How, intellectual property, business and marketing plans, financial       information, customer data, research and development activities and other materials or       information relating to business or activities which are not generally known to the public, all       confidential information of Third Parties in the possession of the disclosing Party; and all       notes, analysis, compilations, studies, summaries and other material prepared by or for the       disclosing Party containing or based, in whole or in part, on any information included in the       foregoing.    1.18. “Corporate Trademarks” means the trade names, corporate names and corporate logos       of Zosano or Zosano’s Affiliates, not specific to the Product, that are used in the Prescribing       Information, Promotional Materials, training materials or other material provided hereunder       or that are authorized or approved by Zosano for use in connection with Eversana’s       performance of activities under this Agreement.                                          3   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      1.19. “Customer” means any Third-Party purchaser of the Product that is not an Affiliate of a       Party.    1.20. “Dedicated Employees” shall have the meaning set forth in Section 3.2.e.   1.21. “Detail” means a face-to-face visit during which a Sales Force representative makes a       presentation with respect to the Product to an Eligible Prescriber, such that (i) the relevant       characteristics of the Product are described by the Sales Force representative in a fair and       balanced manner consistent with the requirements of this Agreement and Applicable Law,       (ii) the Product is the only product presented in such presentation to an Eligible Prescriber       and (iii) such Eligible Prescriber is given an opportunity to prescribe or place an order for       Product in accordance with this Agreement. When used as a verb, “Detail” means to perform       a Detail.    1.22. “Eligible Prescriber” means a health care provider that has the authority to prescribe the       Product under Applicable Law and, in the event the Commercialization Plan includes the       provision of Product samples by members of the Sales Force, Eligible Prescriber shall       further mean, as to the provision of Product samples, a health care provider that is allowed       to receive Product samples.    1.23. “Eversana IP” means all Know-How and other Intellectual Property Rights (a) in Eversana’s       possession and control of as of the Effective Date of this Agreement (“Eversana Pre-      existing IP”) or (b) independently developed by or on behalf of Eversana during the Term       outside of the scope of this Agreement.    1.24. “Executive Officers” means, with respect to Zosano, its Chief Executive Officer, and with       respect to Eversana, its Chief Executive Officer.    1.25. “FDA” means the Unites States Food and Drug Administration.    1.26. “Field” means the [***].     1.27. “Field Alert” means a field alert report, as required under 21 C.F.R. § 314.81(b)(1), as such       regulation may be amended from time to time.    1.28. “Functional Services” means the services set forth in Exhibit C.    1.29. “Governmental Authority” means any federal, state or local court, administrative agency,       commission or other governmental authority or instrumentality, including without limitation       the FDA, having authority in the United States over the activities contemplated hereunder.        Governmental Authority shall include any Regulatory Authority.    1.30. “Intellectual Property Rights” means all intellectual property rights anywhere in the world,       whether or not registered, including without limitation patents, utility models, rights in       inventions, trademarks, service marks, rights in trade dress (including without limitation       product configuration and packaging), rights in business and trade names, rights in domain       names, designs, copyrights, trade secrets, rights in Know-How and confidential information,       and, in each case, rights of a similar or corresponding character.   1.31. “Joint Management Committee” or “Committee” has the meaning set forth in Section 4.                                          4   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      1.32. “Know-How” means all proprietary information related to a product or service, including       without limitation all patentable and non-patentable inventions, discoveries, technologies,       knowledge, trade secrets, experience, skill, techniques, methods, processes (including       without limitation manufacturing processes), procedures, formulas, compounds,       compositions of matter, assays, tests (including without limitation diagnostic tests),       materials, specifications, descriptions, results and data (including without limitation       Manufacturing Data and Regulatory Documentation), business or financial information or       information of any type whatsoever, in any tangible or intangible form, marketing reports,       business plans, standard operating procedures, and procedures.    1.33. “Manufacture” and “Manufacturing” mean all activities related to the manufacture of a       pharmaceutical product for use or sale in the Territory, including without limitation       manufacturing for clinical use or commercial sale, as well as compliance with Applicable       Laws relating to the foregoing activities.    1.34. “Manufacturing Costs” means with respect to the Manufacture of Product (a) to the extent       that Product is Manufactured by Zosano or its Affiliates, or by a Third Party contract       manufacturing organization, the [***] incurred by Zosano or its Affiliate that are [***]       attributable to such Manufacture and/or (b) to the extent that the Product is Manufactured       by (i) a Third Party and subsequently subject to quality control and quality assurance       activities conducted by Zosano or its Affiliates or (ii) Zosano or its Affiliates, the [***] cost of       Manufacture of the Product or the performance of such activities, as calculated in a manner       consistent with a costing methodology agreed to by the Joint Management Committee.    1.35. “Manufacturing Data” means all data, information, material, and documentation developed       or generated with respect to the Manufacturing of a pharmaceutical product, including       without limitation manufacturing and control data and other data and documentation       requested by or submitted to a Regulatory Authority.   1.36. “NDA” means a New Drug Application filed with the FDA requesting permission to place a       drug on the market in accordance with 21 CFR Part 314, and all amendments or       supplements filed pursuant to the requirements of the FDA.   1.37. “NDA Approval” means the approval of an NDA by FDA for the Product in the Territory.    1.38. “NDA Approval Date” means date on which Zosano receives NDA Approval.    1.39. “Net Profit” means Net Sales, less the following: [***].   1.40. “Net Sales” means the gross invoiced price (not including value added taxes, sales taxes       or similar taxes) of Product actually sold to a Customer hereunder after deducting, if not       previously deducted, from the amount invoiced or received:           a.   trade and quantity discounts other than early payment cash discounts that are              actually allowed or granted;          b.   rebates, chargebacks and other allowances that are actually allowed or granted;          c.   credits or allowances actually given or made by Zosano to Customers for rejection              or return of the Products to Zosano;                                           5   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.            d.   retroactive price reductions that are actually allowed or granted;           e.   deductions to gross invoice price of such Product required by a Regulatory              Authority or other Governmental Authority, including without limitation with respect              to a Patient Access Program, Patient Assistance Program, couponing, discount              cards or co-pay assistance program designed to provide a discount to the patient              for a prescription for the Product;          f.   the annual fee on branded prescription pharmaceutical manufacturers and              importers under the Affordable Care Act, to the extent attributable to the Product;           g.   a reasonable reserve up to [***] percent ([***]%) of the amount invoiced to cover              bad debt, early payment cash discounts, transportation and insurance; and           h.   the standard inventory cost of devices or delivery systems that are included as part              of, and intended for, dispensing or administering the Product.    1.41. “Other Reportable Information” means any communication or other information that is       otherwise required to be reported by Eversana to Zosano in accordance with the training to       be provided under this Agreement, other than Adverse Events.              1.42. “Out-of-Pocket Costs” means amounts paid by a Party to Third Parties for goods and       services required for such Party to perform its obligations under this Agreement.     1.43. “Patient Access Programs” means programs to assist patients with filling their       prescriptions, including, without limitation, through co-pay assistance, through help desks,       triage procedures, bailment programs, and reduced cost prescription fulfillment to certain       eligible patients in financial need.    1.44. “Patient Assistance Programs” means any program to offer the Product free of charge, or       at a significant discount, to individuals who are unable to pay for their medication,       alternatively known as indigent drug programs, charitable drug programs or medication       assistance programs.   1.45. “PDMA” means the Prescription Drug Marketing Act of 1987, as amended from time to time,       together with any rules, regulations and requirements promulgated thereunder and in effect       from time to time.   1.46. “Person” means any individual, partnership, limited partnership, limited liability company,       joint venture, syndicate, sole proprietorship, corporation, unincorporated association, trust,       trustee, executor, administrator or other legal personal representative, or any other legal       entity, including without limitation a Governmental Authority.   1.47. “Pre-Commercial Fees” means the total fees (including but not limited to Out-of-Pocket       Costs) agreed upon by the Committee to be paid by Zosano to Eversana in accordance       with the terms set forth herein, for Eversana to perform the Pre-Commercial Services to the       extent such fees and costs are incurred prior to Commercial Launch.    1.48. “Pre-Commercial Budget” means the budget for the conduct of the Pre-Commercial       Services by Eversana hereunder as approved by the Joint Management Committee, as                                          6   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          such budget may be amended from time to time.     1.49. “Pre-Commercial Plan” means the plan for the conduct of the Pre-Commercial Services       by Eversana hereunder as approved by the Joint Management Committee, as such plan       may be amended from time to time.     1.50. “Pre-Commercial Services” means the services set forth in Exhibit A.     1.51. “Prescribing Information” means the FDA-approved labeling for the Product.    1.52. “Product” means Qtrypta (zolmitriptan intracutaneous microneedle system).    1.53. “Product Copyrights” means all copyrightable subject matter related to the Product       included in the Prescribing Information, the Promotional Materials, training materials or       other material provided hereunder or otherwise authorized or approved by Zosano under       this Agreement for use by Eversana in performing the Services.   1.54. “Product Quality Complaint” means any and all manufacturing or packaging-related       complaints related to the Product, including without limitation (a) any complaint involving       the possible failure of the Product to meet any of the specifications for the Product and (b)       any dissatisfaction with the design, package or labeling of the Product.   1.55. “Product Trademarks” means the trademarks used for the Product that are controlled by       Zosano during the Term in the Territory, including without limitation any such trademarks for       the Product used in the Prescribing Information, Promotional Materials, training materials       or other material provided hereunder or otherwise authorized or approved by Zosano,       excluding the Corporate Trademarks.   1.56. “Regulatory Authority” means any national, federal, state, or local governmental or       regulatory authority, agency, department, bureau, commission, council or other government       entity located in the Territory, including without limitation FDA, Centers for Medicare and       Medicaid Services (CMS), and the Office of Inspector General of the U.S. Department of       Health and Human Services, regulating or otherwise (a) exercising authority with respect to       the development, manufacture, approval, registrations, licensing, or commercialization of       the Product in such regulatory jurisdiction in the Territory, or (b) having legal authority with       respect to the exploitation of the Product in the Territory.   1.57. “Regulatory Documentation” means all applications, registrations, licenses,       authorizations and approvals, all correspondence submitted to or received from Regulatory       Authorities (including without limitation minutes and official contact reports relating to any       communications with any Regulatory Authority) and all supporting documents and all clinical       studies and tests, relating to the Product, and all data contained in any of the foregoing,       including without limitation all Regulatory Authority approvals, regulatory drug lists,       advertising and promotion documents and related FDA submissions and correspondence,       adverse event files and complaint files and related FDA submissions.   1.58. “Sales Force” shall have the meaning set forth in Section 3.2.e.   1.59. “Sales & Promotion Policies” means Eversana’s compliance policies and other policies       generally applicable to the Commercialization of pharmaceutical products in the Territory, in                                          7   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.        each case approved by Zosano, as the same may be amended, modified or supplemented      from time to time upon notice by Eversana to Zosano, provided that any such amendment,      modification or supplement is approved by the Committee.   1.60. “Services” means: (a) the day-to-day supervision and management by Eversana of the      Commercialization of the Product in the Territory, including without limitation the Pre-     Commercial Services, the Commercial Services, and the Functional Services and any other      services as may be set forth in a Statement(s) of Work.   1.61. “SGA Costs” means a fixed fee for Zosano’s standard general and administrative costs,      which shall be equal to [***] percent ([***]%) of Net Sales for the applicable reporting period.        1.62. “Statement(s) of Work” shall have the meaning set forth in Section 2.8.   1.63. “Term” shall have the meaning set forth in Section 14.1.   1.64. “Territory” means the United States and all of its territories and possessions.   1.65. “Third Party” means any Person other than Zosano, Eversana and their respective Affiliates.   1.66. “Third Party Royalties” means amounts payable by Zosano to Third Parties for licenses or      rights related to the Product, which solely for purposes of this Agreement shall be deemed      to fixed at [***] percent ([***]%) of Net Sales throughout the Term.    1.67. “Zosano IP” means all Know-How and other Intellectual Property Rights (a) in Zosano’s      possession and control of as of the Effective Date of this Agreement (“Zosano Pre-existing      IP”) or (b) independently developed by or on behalf of Zosano during the Term outside the      scope of this Agreement.   2.  APPOINTMENT, EXCLUSIVITY AND STATEMENTS OF WORK   2.1. Appointment.  On and from the Effective Date and for the duration of the Term, and subject      to the terms of this Agreement, Zosano appoints Eversana to perform the Services, and      Eversana hereby agrees to perform the Services in accordance with this Agreement and      Applicable Law.  Eversana shall use [***] to perform the Services and shall maintain a      reasonably adequate number of qualified and trained staff to execute the Services in a [***]      and workman like manner in accordance with industry standards.    2.2. Exclusivity.        a.    License Grant.  During the Term, subject to the terms and conditions of this            Agreement, Zosano hereby grants Eversana (and [***] (the “Permitted Eversana            Affiliate”) a limited, non-transferable, non-sublicensable (except with the prior            written consent of Zosano at Zosano’s sole discretion), co-exclusive license under            the Zosano IP, Zosano’s interest in the Arising Product IP, the Product Trademarks,            and the Corporate Trademarks, solely to the extent necessary for Eversana to            perform its obligations and provide the Services in the Territory under this Agreement            (the “License”). For clarity, the License does not grant Eversana any right to            Manufacture the Product.                                           8               

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          b.    Non-Compete.  During the Term: (i) no [***] shall, either directly or indirectly, in             conjunction with any Third Party or through any other business arrangement,             Commercialize a Competing Product in the Territory, including without limitation by             [***] (ii) Eversana shall not transfer any [***] to a program that involves [***] for [***];             and (iii) all Eversana employees providing services [***] shall not provide services in             connection with any other product for [***] and all such Eversana employees [***] the             use of or access to Zosano Confidential Information by employees or independent             contractors providing services for [***].  [***].    2.3. Other Rights and Obligations.     a.    Eversana acknowledges and agrees that, as between the Parties, Zosano owns all rights,        title and interest in and to the Intellectual Property Rights and regulatory rights in the        Product.  Zosano reserves the right under the Zosano IP, Zosano’s interest in the Arising        Product IP, the Product Trademarks, and the Corporate Trademarks, to market and offer        for sale Product in the Field in the Territory, through itself or through its Affiliates solely for        the purpose of supporting Eversana’s Commercialization of the Product or as provided in        Section 2.3.b.  Without limiting the foregoing, Zosano shall own all right, title and interest        in and to the Product, the Zosano IP, the Product Trademarks, the Corporate Trademarks,        and the Product Copyrights, and Arising Product IP, and Eversana shall and hereby does        assign to Zosano any and all of its right, title, and interest in, to, and under all Arising        Product IP.  As requested by Zosano, Eversana shall assign to Zosano all right, title and        interest in Arising Product IP, if any, developed by Eversana or its employees during the        Term.   b.    If Zosano desires to obtain Third Party support for Commercialization activities for the        Product that are not the subject of a then-existing SOW, Zosano shall first notify Eversana        of the nature of the support it is seeking and other material information regarding such        potential support.  If Eversana reasonably demonstrates that it can provide the relevant        support at a quality and cost and in a time period comparable to that available from Third        Parties, then the Parties will negotiate in good faith for up to [***] days, or for a period        otherwise agreed upon in writing by the parties the terms pursuant to which Eversana        would provide such support under a new SOW.  If the Parties do not enter into an SOW        within such [***] day time period, or if Eversana fails to reasonably demonstrate that it can        provide the relevant support at a quality and cost and in a time period comparable to that        available from Third Parties, then Zosano shall have the right to engage a Third Party to        provide such support.    2.4. Use of Affiliates and Third Parties.  With the prior written consent of Zosano (except for       the Permitted Eversana Affiliate for which prior consent shall not be required), Eversana       shall have the right to perform any or all of its obligations and exercise any or all of its rights       under this Agreement through any of its Affiliates or through a Third Party; provided,       however, that (a) any such Affiliate or Third Party shall be bound by the obligations set forth       in this Agreement, (b) any actions, omissions or conduct by such Affiliate or Third Party shall       be deemed to be actions, omissions or conduct of Eversana, and (c) Eversana shall remain       liable for all acts and omissions of such Affiliates or Third Parties and shall remain       responsible for the performance of its obligations under this Agreement.    2.5. Initial Delivery of Information and Materials.  Zosano shall promptly deliver to Eversana                                          9   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          copies or embodiments of all information and materials controlled by Zosano (including       Zosano IP, as determined by Zosano) relating to the Product that Zosano in its reasonable       discretion deems to be necessary for Eversana to perform the Services in the Territory in       accordance with the terms and conditions of this Agreement and Applicable Law.    2.6. Provision of Assistance and Support.  Upon written request by Eversana, Zosano shall       promptly provide to Eversana or if applicable its Affiliates, such reasonable and currently       available information and materials controlled by Zosano relating to the Product as is       necessary for Eversana to perform the Services in the Territory in accordance with the terms       and conditions of this Agreement and Applicable Law.   2.7. Non-Solicitation.  During the Term of this Agreement and, except as permitted under       Section 14.3.b below, for a period of [***] after the Term, neither Party shall, directly or       indirectly, in any manner solicit for employment, or hire, any employee or contractor of the       other Party or induce any such employee or contractor to terminate their employment or       contractual relationship with the other Party.  A general advertisement or notice of a job       listing or opening or other similar general publication of a job search or availability to fill       employment positions, including without limitation on the internet, shall not be construed as       a solicitation or inducement for the purposes of this provision.  If either Party breaches this       Section 2.7, the breaching Party shall pay a sum to the other Party equal to [***] payable by       the non-breaching Party to the relevant employee, plus the recruitment costs incurred by       the non-breaching Party in replacing such individual.     2.8. Statement(s) of Work.  Certain Services to be provided by Eversana to Zosano, such as       the provision of a Sales Force and other Pre-Commercial Services and Commercial       Services, are set forth in detail in this Agreement.  The Parties acknowledge and agree that       to the extent the Parties agree that Eversana will provide additional Services to Zosano in       furtherance of the Commercialization of the Product in the Territory, the details of such       additional services shall be set forth in one or more “Statement(s) of Work” or “SOW”. For       example, and without limitation, the Parties agree to enter into Statements of Work       addressing the provision by Eversana of patient support and market access services.               Unless specifically so provided in a Statement of Work, any terms and conditions       within a Statement of Work that contradict the terms and conditions set forth in this       Agreement shall be null, void and of no force or effect, it being understood and agreed by       the Parties that the terms and conditions set forth in this Agreement shall govern and control       to the extent of a conflict with the terms and conditions of a SOW with respect to the Services       provided by Eversana and the overall relationship of the Parties.  Statements of Work are       intended solely to set forth a description of the Services not otherwise set forth in this       Agreement as well as applicable deliverables, schedules, milestones and payments (if not       otherwise set forth herein), with the terms and conditions of this Agreement continuing to       apply to such Services in all other respects.    3.  COMMERCIALIZATION    3.1. Alliance Managers.  Each Party shall designate a single person (each, an “Alliance       Manager”) to oversee contact between the Parties for all matters related to       Commercialization of the Product in the Field in the Territory by Eversana on behalf of       Zosano hereunder.  The Alliance Managers shall: (a) strive to function as a single point of       contact in all substantive communications with the other Party; and (b) perform any other                                         10   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.        functions agreed in writing by the Parties.  Each Party may replace its Alliance Manager at      any time by written notice to the other Party.  The initial Alliance Managers are set forth on      Exhibit E.   3.2. Pre-Commercial Plan and Pre-Commercial Budget; Commercialization Plan and      Commercialization Budget       a.    Content.  Promptly after the Effective Date, Eversana shall prepare and submit to            the Committee for review and approval (i) a Pre-Commercial Plan and Pre-           Commercial Budget and (ii) a Commercialization Plan and a Commercialization            Budget, in each case of (i)-(ii), for the relevant Services to be conducted by Eversana            on behalf of Zosano for the Product in the Territory hereunder.  Eversana is            responsible for all activities under the Pre-Commercial Plan and Commercialization            Plan, except to the extent the Pre-Commercial Plan and Commercialization Plan            accounts for activities and functions as set forth in Exhibit D, which such activities            and functions shall instead be provided by Zosano personnel in connection with this            Agreement.  The Pre-Commercial Budget and Commercialization Budget will            include [***]. All subsequent versions of updates to the Pre-Commercial Plan, Pre-           Commercial Budget, Commercialization Plan and Commercialization Budget are            subject to the written approval of the Committee. It is anticipated that the total            amount of Pre-Commercial Fees and Commercialization Fees to be incurred by            Eversana and paid or reimbursed by Zosano [***] during the entire Term shall be            approximately Two Hundred and Fifty Million Dollars ($250,000,000), subject to the            terms and conditions set forth herein.       b.    Updates.  [***], or on another frequency agreed to by the Committee, Eversana shall            update the Pre-Commercial Plan, Pre-Commercial Budget, Commercialization Plan            and Commercialization Budget to cover Services to be provided during the            remainder of the Term. Eversana shall submit such updated Commercialization            Plans and Commercialization Budgets to the Committee for review and approval.            Within [***] days following such submission, the Committee shall either approve the            Pre-Commercial Plan, Pre-Commercial Budget, Commercialization Plan and            Commercialization Budget prepared by the Parties or approve a modified            Commercialization Plan and Commercialization Budget reflecting adjustments            agreed upon by the Committee. Any proposed changes to a previously approved            Commercialization Plan or Commercialization Budget shall not take effect unless            and until reviewed and approved in writing by the Committee.        c.    Eversana Responsibilities and Expenses.  Eversana shall provide the Services            as set forth in the Pre-Commercial Plan and Commercialization Plan and shall be            responsible for all costs incurred under the Pre-Commercial Budget and            Commercialization Budget, as well as under any additional SOW entered into by the            Parties, subject to the reimbursement and payment obligations set forth in Section            5 below.       d.    Zosano Responsibilities.  Zosano shall provide the functions and responsibilities            set forth herein, including without limitation Product Manufacturing and obtaining and            maintaining all regulatory approvals for the Product in the Territory as required by            Applicable Law.                                         11               

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          e.    Sales Force.  Eversana shall engage employee sales representatives as set forth             in the Commercialization Plan (the “Sales Force”) to Commercialize the Product in             the Territory and in accordance with this Agreement.  Eversana shall engage at least             [***] Eversana sales representatives to so Commercialize the Product in the Territory             upon the date agreed to by the Committee and set forth in the Commercialization             Plan and such sales representatives shall be [***] dedicated to the Product to             perform the Commercialization activities for the Product as set forth under Exhibit B             (the “Dedicated Employee(s)”).  For clarity, and by way of example only, [***].              Eversana would be permitted, subject to the Committee’s written approval, to             decrease the number of sales representatives in the Sales Force [***] as appropriate             due to [***].    3.3. Field Observations and Sales Meetings.        a.    Upon Zosano’s request, Eversana shall conduct a reasonable number of field             observations per year, with a minimum of [***] per year per Eversana sales             representative (which field observations Zosano may also attend in its reasonable             discretion) during normal business hours to evaluate overall quality assurance of the             Detailing of the Product by the Sales Force representative. If any such observations             indicate that a Detail is not being delivered or received in accordance with the terms             set forth in this Agreement or in compliance with Applicable Laws, Eversana shall             promptly report such deficiencies to Zosano, and the Alliance Managers shall             discuss what, if any, corrective plan of action is required to address such issue;             provided that the Committee shall have the sole authority to determine whether to             change the content of the Promotional Materials or messages being delivered with             respect to the Product during Details.        b.    At any sales meetings (e.g. annual sales meetings, training meetings, plan of action             meetings) in the Territory during which the Product is discussed, Eversana shall have             a reasonable number of Eversana personnel with responsibilities for the Product             attend such sales meetings (which meetings Zosano may also attend in its sole             discretion) and, if necessary, communicate critical Product-related information (as             determined by the Committee) at such meetings.    3.4. Training Program and Materials.  Eversana shall train the members of the Sales Force,       prior to such member performing any Commercialization activities in the Territory hereunder,       with respect to: (i) Product knowledge; (ii) competitive product knowledge; (iii) compliance       with Applicable Law; (iv) reporting of Adverse Events, Field Alerts, Product Quality       Complaints and Other Reportable Information; (v) use of Product samples (if applicable)       and Promotional Materials; and (vi) such other information the Committee deems necessary       or appropriate. All such Sales Force training conducted by Eversana shall be in accordance       with training materials prepared by Eversana and approved in writing by Zosano.  Prior to       Commercialization of the Product in the Territory, Eversana shall verify to the Committee       that each Sales Force representative has (a) satisfactorily completed the initial training, (b)       has completed role-playing scenarios of a Detail of the Product and has received a       certification from Eversana of competence in connection therewith, and (c) shall verify on       an annual basis that each Sales Force representative maintains any required licenses.   3.5. Promotional Materials.  Eversana shall be responsible for designing and producing                                          12   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          promotional, marketing and educational materials (in any form or medium), such as printed       brochures, videos, and other materials for use by Sales Force representatives, distributors       or medical providers or in advertisements or web sites (“Promotional Materials”) in       coordination with and based on feedback from Zosano. Eversana shall provide Zosano with       copies of all drafts of Promotional Materials in a timely manner to enable Zosano to review       and approve in writing such Promotional Materials.  Zosano is solely responsible for       ensuring any and all Promotional Materials are reviewed and approved by appropriate       medical, legal and regulatory personnel to ensure compliance with Applicable Laws.        Eversana will not use any Promotional Materials in the performance of any       Commercialization activities hereunder unless Zosano has approved such Promotional       Materials in advance in writing.    3.6. Sales Reports.  Without limiting Eversana’s reporting obligations elsewhere in this       Agreement, within [***] days after the end of each calendar month, Eversana shall deliver       to Zosano a report setting forth the total prescriptions for the Product written in the Territory       (regardless if contacted by representatives of Eversana) during such calendar month       broken out by Sales Force representative and territory.    3.7. No Registration of Trademarks and Copyrights.  Eversana shall not use (other than in       connection with the Services as approved by the Committee), seek to register or register,       nor permit any of its Affiliates to use, seek to register or register, any trademark, service       mark, name or logo, including without limitation as part of any domain name, social media       handle or other identifiers, which is confusingly similar to, or a colorable imitation of, the       Product Trademarks, Corporate Trademarks or Product Copyrights in any jurisdiction       worldwide.  Eversana shall not challenge, nor permit any of its Affiliates to challenge,       Zosano’s or its Affiliates’ rights in, or the validity, enforceability, scope, or registerability of,       any of the Product Trademarks, Corporate Trademarks or Product Copyrights or any       registration or application therefor.   3.8. Channel Management Services.  Promptly after the Effective Date, the Parties agree to       negotiate in good faith the terms and conditions of an SOW whereby Eversana shall, on       behalf of Zosano, manage and supervise the logistics, distribution, marketing (within the       Eversana commercial sales organization), and sale of the Products and coordinate activities       within its 3PL division for such logistics and distribution of the Products in the Territory (the       “3PL SOW”).  [***].    4.   MANAGEMENT OF THE COLLABORATION    4.1. Joint Management Committee.  The Parties shall establish a committee (the “Joint       Management Committee” or “Committee”) as more fully described in this Section 4.  The       Committee shall have review, oversight, and decision-making responsibilities for all       Commercialization activities performed under this Agreement.  Each Party agrees to keep       the Committee informed of its progress and activities under this Agreement.  The Committee       shall convene at least [***], or more frequently as requested by either Party’s Alliance       Manager, to discharge its responsibilities.  The Alliance Managers shall meet at least [***].   4.2. Membership.  The Committee shall be comprised of [***] representatives (or such other       number of representatives as the Parties may agree) from each of Zosano and Eversana.       Each Party shall provide the other with a list of its initial members of the Committee no later       than [***] days prior to the first scheduled meeting of the Committee, which shall be no later                                         13   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          than [***] days after the Effective Date. Each Party may, in its reasonable discretion, invite       non-member representatives of such Party to attend meetings of the Committee as non-      voting participants, subject to the confidentiality obligations of Section 11.  Each Party may       replace any or all its representatives on the Committee at any time upon written notice to       the other Party.  Each representative of a Party shall have relevant expertise in       pharmaceutical drug product Commercialization, and be suitable in seniority and       experience and have been delegated the authority to make decisions on behalf of the       applicable Party with respect to matters within the scope of the Committee’s responsibilities.        Any member of the Committee may designate a substitute with comparable experience and       expertise to attend and perform the functions of that member at any meeting of the       Committee.  Zosano shall designate a chairperson to oversee the operation of the       Committee.  Such chairperson shall confer with the Alliance Managers of both Parties prior       to each Committee meeting to identify issues for review and discussion at each Committee       meeting and circulate a meeting agenda at least [***] before the meeting.   4.3. Responsibilities.  The Committee shall perform the following functions:          a.   review and approve the Pre-Commercial Plan and the Commercialization Plan or              recommend amendments or revisions thereto;          b.   review and approve the Pre-Commercial Budget Commercialization Budget or              recommend amendments or revisions thereto;          c.   [***];          d.   review and approve payer contracting;          e.   monitor and assess the effectiveness and performance of Eversana’s Sales Force              representatives hereunder and consider and decide (i) whether to expand or              reduce the size of the Sales Force and (ii) whether the Sales Force deployment              requires territory realignment;                           f.    in the event the Parties execute the 3PL SOW, monitor and oversee the conduct              of channel management services pursuant to the 3PL SOW, and any additional              Services conducted pursuant to additional SOWs;                            g.    coordinate the preparation of training materials and oversee and monitor the              training, in each case in accordance with Section 3.4;                            h.    review and approve Promotional Materials, provided that, pursuant to Section 3.5:              (i) all such Promotional Materials will be reviewed and approved by Zosano and its              medical, legal and regulatory personnel to ensure compliance with Applicable              Laws (as set forth in Section 3.5 above) prior to Committee review, and (ii) the              Committee will not be permitted to change any Promotional Materials without the              prior written consent of Zosano; and           i.   in the event the Parties execute the 3PL SOW, review and approve channel              management strategies and tactics.             The Committee shall further serve as a forum for discussion and shall perform such                                          14   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          other functions as may be agreed to by the Parties mutually in writing or as otherwise       expressly specified elsewhere in this Agreement.     4.4. Decisions.  Except as otherwise provided herein, with respect to Commercialization of the       Product, all decisions of the Committee shall be made by consensus, with each Party having       one vote.  If the Committee cannot agree on a matter within its authority hereunder within       [***] days after it has met and attempted to reach such decision, then, either Party may, by       written notice to the other, have such issue referred to the Executive Officers for resolution.        The Parties’ respective Executive Officers shall meet within [***] days after such matter is       referred to them and shall negotiate in good faith to resolve the matter.  If the Executive       Officers are unable to resolve the matter within [***] days after the matter is referred to them,       then the issue shall be finally resolved by Zosano.    5.   Fees and Payments    5.1. Product Supply.  Zosano shall supply the Product to Eversana for the purposes of       performing the Services hereunder [***].     5.2. Pre-Commercial Fees.  [***] of all Pre-Commercial Fees shall be paid by Zosano to       Eversana on a [***] basis, [***]. Eversana shall invoice Zosano for said [***] of such Pre-      Commercial Fees on a [***] basis [***] and   Zosano shall pay all undisputed amounts of       such invoices within [***] days of receipt thereof. The balance of the Pre-Commercial Fees       shall be treated as [***].   5.3. Reporting of Sales; Calculation of Net Sales.  Within [***] days after each month end,       Eversana shall report to Zosano the [***] and other sales data that is suitable for use under       generally accepted accounting principles (“GAAP”), as well as any other information       reasonably necessary for Zosano to calculate Net Sales (including without limitation       information regarding rebates, discounts, chargebacks and other deductions).    5.4. Payment to Eversana of Certain Fees and Costs.  Subject to Section 5.6, on a [***] basis       following receipt of monies from sales of the Product made in the Territory and at such time       when Zosano has received from Eversana all necessary information and has the ability to       recognize the sales of such Product on its balance sheet in accordance with GAAP, the       following amounts shall be deducted from such Net Sales in accordance with Section 5.6       below and shall be paid to Eversana: (a) the agreed upon compensation as set forth in the       Commercialization Budget for the applicable reporting period and (b) [***] (collectively       “Commercialization Fees”).   5.5. Payment to Zosano of Certain Fees and Costs.  Subject to Section 5.6, on a [***] basis       following receipt of monies from sales of the Product made in the Territory and at such time       when Zosano has received from Eversana all necessary information and has the ability to       recognize the sales of such Product on its balance sheet in accordance with GAAP, the       following amounts shall be deducted from such Net Sales in accordance with Section 5.6       below and shall be paid to Zosano (or retained by Zosano, as applicable): (a) Manufacturing       Costs incurred for the applicable reporting period, (b) SGA Costs incurred for the applicable       reporting period, and (c) Third Party Royalties incurred for the applicable reporting period.      5.6. Party Reimbursement. During each [***] in which Net Sales are generated, the payments       to the Parties described in Sections 5.4 and 5.5 above, shall first be calculated and paid as                                          15   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          set forth in this Section 5.6.  First, a pool of available reimbursement funds shall be       calculated for each Party out of Net Sales in such [***], which for each of Section 5.4 and       Section 5.5 shall be equal to  [***] percent ([***]%) of the Net Sales recognized by Zosano       in accordance with GAAP during such [***] (such amount available for reimbursement under       each of Section 5.4 and 5.5, respectively, a “Party Reimbursement Pool”).  Zosano shall       then pay to Eversana from the Party Reimbursement Pool [***] provided that Zosano shall       not be required to pay in any [***] to Eversana any amounts [***] in excess of the Party       Reimbursement Pool for [***] for such [***] (the “Limit”), and further provided that any such       amounts payable to Eversana [***] that are not so deducted from the Party Reimbursement       Pool [***] in a [***] by reason of the Limit shall roll forward to future [***] until such amounts       have been fully deducted from the Party Reimbursement Pool [***].  Similarly, Zosano shall       then deduct from the Party Reimbursement Pool [***] for such [***] the amounts Zosano is       permitted to deduct [***], provided that if any amount Zosano is permitted to deduct in a [***]       pursuant to [***] exceeds the Party Reimbursement Pool [***] for such [***] (such excess       amounts, the “Excess”), Zosano shall roll forward to future [***] the Excess [***]    5.7. Profit Sharing.  Following payments and deductions [***] from each Party Reimbursement       Pool in accordance with Section 5.6, during the applicable [***], Zosano shall compensate       Eversana by paying [***] ([***]%) of any remaining annual Net Profit, with Zosano retaining       the remainder (“Profit Split”).  Notwithstanding the prior sentence, to the extent Net Profits       on annual Net Sales exceed [***] Dollars ($[***]), Zosano shall compensate Eversana by       paying [***] ([***]%) of such portion of annual Net Profits (and Zosano retaining the       remainder of such portion of annual Net Profits). The Parties shall agree on and implement       an appropriate true-up mechanism to effect the foregoing allocation of annual Profit Split.        Zosano shall provide to Eversana [***] estimates of the Profit Split it expects to distribute for       such [***] in accordance with this Section 5.7.      5.8. Manner of Payment.  Zosano shall pay to Eversana the amount required to effectuate the       Profit Split in accordance with Section 5.7 above for each applicable reporting period by       wire transfer to a bank account designated by Eversana.  All payments owed under Sections       5.4, 5.5 and 5.6 shall be paid on a [***] basis, with such payment being made for the prior       [***] no later than [***] days after the end of such prior [***] in which such amounts could be       calculated.     5.9. Taxes.     a.    Except as provided in this Section 5.9, each Party shall be liable for all income and other        taxes (including interest) imposed upon any payments received by such Party under this        Agreement, including this Article 5. The amounts payable by a Party (the “paying Party”)        to the other Party (the “receiving Party”) pursuant to this Agreement shall be paid free        and clear of any and all taxes; provided that a paying Party shall be entitled to deduct and        withhold from any amounts payable pursuant to this Agreement such taxes as are required        to be deducted or withheld therefrom as required by Applicable Law.  The paying Party        shall deduct or withhold from the payments any taxes that it is required by Applicable Law        to deduct or withhold; provided, however, that before making any such deduction or        withholding, the paying Party shall give the receiving Party notice of the intention to make        such deduction or withholding (such notice, which shall include the authority, basis and        method of calculation for the proposed deduction or withholding, shall be given at least a        reasonable period of time before such deduction or withholding is required, in order for                                          16   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.           such receiving Party to obtain reduction of or relief from such deduction or withholding in        accordance with the following sentence).  Notwithstanding the foregoing, if the receiving        Party is entitled under any applicable tax treaty to a rate reduction of, or the elimination of,        applicable withholding tax, it may deliver to the paying Party or the appropriate        Governmental Authority (with the assistance of the paying Party 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 the paying Party of its obligation        to withhold such tax and the paying Party shall apply the reduced rate of withholding or        dispense with withholding, as the case may be; provided that the paying Party has        received evidence, in a form satisfactory to the paying Party, of the receiving Party’s        delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental        authorization) at least [***] days prior to the time that the payments are due.  If, in        accordance with the foregoing, the paying Party withholds any amount, it shall pay to the        receiving Party the balance when due, make timely payment to the proper taxing authority        of the withheld amount and send to the receiving Party proof of such payment within [***]        days following such payment.   b.    In addition, the Parties shall cooperate in accordance with Applicable Laws to minimize        indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes        (“Indirect Taxes”)) in connection with this Agreement, as applicable (including providing        resale exemption certificates, if applicable).    c.    Each Party has provided a properly completed and duly executed IRS Form W-9 or        applicable Form W-8 to the other Party and shall provide such updated IRS Form W-9 or        applicable Form W-8 at the time or times reasonably requested by the other Party or as        required by Applicable Law.   d.    Notwithstanding the foregoing, in the event that a Party (or its assignee pursuant to        Section 16.4) redomiciles or assigns its rights or obligations under this Agreement        pursuant to Section 16.4 (each action, a “Tax Action” and such Party, the “Acting Party”),        and as a result of such Tax Action, (i) the Acting Party is required by Applicable Law to        withhold taxes, or such Tax Action results in the imposition of Indirect Taxes that were not        otherwise applicable, from or in respect of any amount payable under this Agreement to        the other Party (the “Non-Acting Party”), and (ii) such withholding taxes or Indirect Taxes        exceed the amount of withholding taxes or Indirect Taxes that would have been applicable        but for such Tax Action, then any such amount payable shall be increased to take into        account such withholding taxes or Indirect Taxes as may be necessary so that, after        making all required withholdings (including withholdings on the additional amounts        payable) and/or paying such Indirect Taxes, as the case may be, the Non-Acting Party        receives an amount equal to the sum it would have received had no such increased        withholding been made and no such Indirect Taxes had been imposed. The obligation to        adjust payments pursuant to the preceding sentence shall not apply, however, to the extent        such increased withholding Tax or Indirect Taxes would not have been imposed but for a        Tax Action by the Non-Acting Party pursuant to the preceding sentence, to the extent such        Tax Action occurs after the Tax Action referenced in the preceding sentence. For purposes        of this Section 5.9, a “redomiciliation” shall include a reincorporation or other action        resulting in a change in tax residence of the applicable Party or its assignee.   e.    The Parties intend that Eversana be treated as providing commercialization services to                                          17   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.           Zosano pursuant to this Agreement and it is expressly agreed that the relationship        between Eversana and Zosano shall not constitute a partnership, joint venture, agency or        similar business relationship, including for all tax purposes.      5.10. Loan Facility.  Pursuant to and subject to the terms and conditions of a loan agreement on       the terms attached as Exhibit F (the “Loan Agreement”), and following Zosano’s receipt of       NDA Approval for the Product, and as further specified in this Section 5.10, Eversana will       provide Zosano with a revolving loan facility of five million dollars ($5,000,000) (the “Loan”)       which can be [***] and used by Zosano pursuant to the terms and conditions set forth in       such Loan Agreement and solely in connection with Zosano’s obligations and       responsibilities under this Agreement (i.e., Manufacturing Costs, IP development,       prosecution, maintenance and enforcement, regulatory activities for the Product).  Following       NDA Approval for the Product, Zosano can access up to $1 million of the Loan on November       1, 2020 and an additional $1 million on December 1, 2020. The remaining drawdowns are       to occur in 2021 with [***] written notice to Eversana.  All amounts drawn down from the       loan shall bear interest at a rate of 10% annually, to be paid monthly as further outlined in       the Loan Agreement.  Zosano would have the right to repay the loan at its option and without       penalty prior to termination.  The Loan shall be paid in full to Eversana on the earlier of       termination (for any or no reason), Change of Control by Zosano, or expiration of this       Agreement, or as otherwise set forth in the Loan Agreement. At least [***] days prior to a       Change of Control by Eversana, Zosano shall pay all outstanding interest due on the Loan       as of the date Zosano received notice of such Change of Control.      5.11. Rate Increases. In the course of agreeing upon the Commercialization Budget, Eversana       will specify the costs for services or activities to be performed by individual Eversana       employees or independent contractors over a [***] month period (the “Fee Listing”).  On       each [***]-month anniversary of the Effective Date, Eversana shall have the right to increase       any then-current agreed-upon compensation to be paid by Eversana for such employees or       independent contractors performing Services for Zosano hereunder during the subsequent       [***] month period, by an amount [***] of [***] percent ([***]%) of the applicable Fee Listing       or the applicable Fee Listing multiplied by [***] for the immediately preceding year of the       Term, or as otherwise agreed to in writing by the Parties, for such employee’s or       independent contractor’s Services, as agreed upon by the Committee in the applicable       Commercialization Budget.   6.   REGULATORY MATTERS    6.1. Ownership of Regulatory Documentation and Approvals.  Zosano is solely responsible       for and owns all right, title and interest in and to (a) all Regulatory Documentation       concerning the Product in the Territory and all information contained therein, (b) all       regulatory approvals made or granted with respect to the Product in the Territory, including       without limitation any NDA Approval, and (c) all final Promotional Materials approved by       Zosano for use in the Territory pursuant to Section 3.5.    6.2. Responsibility for Regulatory Approvals and Regulatory Communications.         a. Zosano has the sole right and responsibility for any regulatory approvals with respect to          the Product in the Territory.        b. Zosano has the sole right and obligation: (i) to make any communications, reports,                                         18   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.           submissions and responses to FDA concerning the Product in the Territory, including         without limitation by reporting Adverse Events, Other Reportable Information and Field         Alerts and (ii) to take any action (including without limitation any investigations) and         conduct all communications with all Third Parties that relate to all Product Quality         Complaints or complaints related to tampering or contamination with respect to the         Product, Adverse Events, Other Reportable Information and Field Alerts with respect to         the Product; provided, however, that Eversana shall be responsible for any         communications, reports, submissions or responses to Regulatory Authorities that it may         be required to make under Applicable Law in connection with performing the Services;         and provided, further that Eversana shall, to the extent permitted by Applicable Law,         provide Zosano with either (x) reasonable advance written notice of, and an opportunity         to discuss in good faith, any proposed communication with FDA in advance thereof with         respect to the Product or any activities of Eversana hereunder or (y) otherwise provide         written notice to Zosano of any communication with FDA concerning the Product or any         activities of Eversana hereunder promptly following such communication and attach         copies of such communication (whether by FDA or Eversana) to such notice.  Eversana         will consider all comments made by Zosano with respect to the proposed         communications with the FDA pursuant to the immediately preceding sentence.          Notwithstanding the above, all investigations of Eversana employees or agents related         to employment matters and Eversana internal policies and procedures may be         conducted independently (with prompt notice to Zosano as provided in Section 6.3.d.         hereof) by Eversana, provided that Eversana shall report to Zosano the results of any         such investigations promptly after the completion thereof, and all investigations relating         to the Product or potential violations of Applicable Law by Eversana shall be conducted         in collaboration with Zosano.       c. Eversana shall cooperate with Zosano’s reasonable requests and assist Zosano in         connection with Zosano’s: (i) preparing any and all reports to FDA concerning the         Product; (ii) preparing and disseminating all communications to Third Parties concerning         the Product; and (iii) investigating and responding to any product quality complaint,         adverse event, other reportable information, Field Alert, or other compliance inquiry or         investigation related to the Product.  Notwithstanding anything to the contrary set forth         above, Zosano is solely responsible for any and all communications with a         Governmental Authority related to the Product and for ensuring all such communications         comply with Applicable Laws.  For purposes of clarification, Zosano shall be responsible         for any and all regulatory reporting requirements including but not limited to aggregate         spend reporting, reporting required by any State, as applicable, and pursuant to the         disclosures required under the Patient Protection and Affordable Care Act (“PPACA”),         even if there are joint disclosure obligations; and to the extent Eversana is deemed an         applicable manufacturer under PPACA, Zosano shall provide Eversana with         confirmation  that such disclosures were properly made.  Zosano is also solely         responsible for: (x) all state and other municipal disclosures, including without limitation         those related to drug samples, marketing expenses, product pricing, etc., and (y) all         state and local municipal disposal laws related to the Product.  Eversana shall         reasonably cooperate with and assist Zosano, as reasonably requested in connection         with such reporting requirements, including by providing Zosano, on a monthly basis,         with details of Eversana’s aggregate spending in connection with the program set forth         herein, to allow Zosano to comply with the reporting requirements set forth above.                                          19               

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.        d. Zosano is responsible for (i) all communications, whether written or oral, to a Third Party         regarding a Product Quality Complaint, Adverse Event, Other Reportable Information,         Field Alert, or other compliance inquiry or investigation with respect to the Product in the         Territory, and (ii) taking any action concerning any Regulatory Authority approval under         which the Product is sold in the Territory.  For clarification, in the event Eversana         becomes aware of a Product Quality Complaint, Adverse Event, Other Reportable         Information, Field Alert, or other compliance inquiry or investigation with respect to the         Product, Eversana is only responsible for informing the Third Party that information in         respect thereof has been or will be conveyed by Eversana to Zosano.  6.3. Adverse Events, Other Reports and Threatened Governmental Authority Action.       a. Eversana shall report to Zosano and the Committee within [***] hours from the time it         becomes aware of any of the following (to the extent such event may reasonably impact         the Product in the Field in the Territory):           i. an Adverse Event or Other Reportable Information associated with the use of the            Product or information in or coming into its possession or control concerning such            Adverse Event or Other Reportable Information;         ii. information that might necessitate the filing by Zosano of a Field Alert;         iii. information relating to an actual or threatened recall of the Product; or         iv. any Product Quality Complaint associated with the use of the Product.   b.   Without limitation of Section 6.3.a., with respect to Adverse Events, Other Reportable       Information, Field Alerts, recall, and Product Quality Complaints, in each case with respect       to the Product, Eversana shall (i) train and inform members of the Sales Force in       accordance with this Agreement, the Sales Force compliance program created and       executed pursuant to Section 8.1, and Applicable Law, and require any Eversana       employee who has performed or is performing any Commercialization activity under this       Agreement, to comply with Applicable Law in connection with collection of information       regarding the foregoing, and the reporting of such information; and (ii), establish and       actively supervise and manage procedures and protocols reasonably designed to ensure       that all relevant information relating to the foregoing that comes to the attention of       Eversana, with respect to any member of the Sales Force or any Eversana employee who       has performed or is performing any Commercialization activity under this Agreement, is       promptly conveyed to Eversana so that Eversana can comply with its reporting obligations       hereunder.  For the avoidance of doubt, Eversana shall be responsible for training,       informing, managing, and supervising members of the Sales Force in accordance with this       Agreement and Applicable Law, and Eversana shall notify Zosano promptly should any       member of the Sales Force fail to comply with the policies and procedures of Eversana or       Applicable Law.       c. Zosano may, at its option, establish procedures for members of the Sales Force to         provide such information referenced in Sections 6.3.a. and 6.3.b. directly to Zosano or         its designee, which procedures may be established or modified by Zosano from time to         time by written notice to Eversana and the Committee.       d. Unless restricted or prohibited by Applicable Law or Governmental Authority, Eversana         shall promptly notify Zosano if it receives information regarding any threatened or         pending action regarding the Product by any Governmental Authority in the Territory.                                        20               

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.        e. All training materials regarding Adverse Events, Other Reportable Information, Field         Alerts and Product Quality Complaints to be utilized by Eversana in connection with its         provision of the Services shall either be provided by Zosano to Eversana or, to the extent         Eversana prepares such materials, shall be approved in writing by Zosano.  These         training materials shall include the contact number and method of transferring potential         reports and any specific product information related to the Product.   7. PRODUCT MATTERS    7.1. Orders for Product; Terms of Sale; Returns.  All sales will be recorded and booked solely      in Zosano’s name.  Zosano shall have the ultimate responsibility to set the policy for taking,      accepting, rejecting or cancelling orders, filling orders and establishing and modifying the      terms and conditions of the sale of the Product (including without limitation with regard to      any Patient Assistance Programs, Patient Access Programs, co-pay assistance programs,      and returns), subject to compliance with the approved Commercialization Plan and all action      plans previously approved by the Committee.  [***]    7.2. Returned Product.  Eversana shall notify Zosano of any returned Product, cooperate with      Zosano regarding the handling of such Product, and follow such other Product return      procedures as shall be agreed upon in the 3PL SOW.   7.3. Recalled Product.  Each Party shall promptly notify the other Party in writing of any facts      relating to the advisability of the recall, withdrawal or withholding from the market of the      Product in the Territory.  Zosano shall have the sole responsibility and right to determine if      any recall, withdrawal or other form of market action is necessary with respect to the Product      and shall be solely responsible for taking all actions to effect such recall, withdrawal or      market action.  At Zosano’s request, Eversana will cooperate with Zosano regarding      Zosano’s handling of any recalls, withdrawals or market actions in the Territory.  Zosano      shall be responsible for all costs incurred in connection with any recalls, withdrawals or      market actions concerning the Product except that Eversana shall be responsible for such      costs if such recalls, withdrawals or market actions are solely caused by Eversana’s      negligence, failure to comply with Applicable Law, or breach of this Agreement.   8. COMPLIANCE MATTERS   8.1. Compliance with Laws and Policies.   a.   Eversana shall train the Sales Force on compliance with Applicable Laws and in       accordance with Section 3.4, and shall promptly inform Zosano of any incident of       noncompliance by such Sale Force that comes to the attention of Eversana. Without       limiting the foregoing, Eversana shall cause the Sales Force and its other personnel       performing the Services to comply with Zosano’s anti-corruption and anti-bribery policy,       approved by the Committee in advance and in writing.  Zosano shall similarly comply with       such anti-corruption and anti-bribery policies, and approved by the Committee in advance       and in writing. Eversana shall notify Zosano in writing promptly if any Third Party (including       without limitation any Governmental Authority) notifies Eversana that either Party’s       Commercialization activities are not in compliance with Applicable Law.  Each Party shall       be legally responsible and liable for the actions, omissions and conduct of its and its       Affiliates employees and agents in connection with their performance hereunder, including       without limitation any breach of Applicable Laws thereby.                                         21               

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      b.   Without limiting Section 8.1.a, Eversana shall maintain a Sales Force compliance program        that includes: (i) Eversana compliance monitoring focused on specific risk areas (including        without limitation off-label promotion, fraud and abuse and false claims) to assess whether        Eversana’s policies and procedures are being followed by the Sales Force; and (ii) a        mechanism for the Sales Force to report, anonymously if they choose, any concerns        including without limitation matters such as potential illegal activity.  Eversana shall report        to Zosano promptly, but in no event later than [***] after becoming aware of any allegation        or investigation of illegal activity (and before reporting any such activity to any        Governmental Authority) with respect to the alleged failure by a member of the Sales Force        to comply with the requirements set forth in Section 8.1.a or any reports provided pursuant        to clause (ii) above and what action, if any, was taken by Eversana as a result.   Eversana        will comply with any reasonable requests by Zosano for additional information regarding        such activity or reports.   The Committee shall review and approve Eversana’s Sales Force        compliance program.     c.     The Parties acknowledge and agree that any direct or indirect payment or transfer of         value, as defined in the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h(e)(10))         and its implementing regulations (42 C.F.R. § 403.900 et seq.), including without limitation         any compensation, reimbursement for expenses, meals, travel, and medical journal         reprints (“Payments or Transfers of Value”) to any physician licensed to practice in the         Territory or any teaching hospital in the Territory (each, a “Covered Recipient”) is subject         to transparency reporting requirements, including without limitation disclosure on the         federal Open Payments website.  Eversana shall implement Eversana’s policies and         procedures requiring the Sales Force not to contract with or make any Payment or         Transfer of Value to a Covered Recipient on behalf of Zosano without the prior written         approval of Zosano.  Eversana shall comply with all reporting required by Applicable Law         with respect to any Payments or Transfers of Value provided by the Sales Force to         Covered Recipients in connection with this Agreement that come to the attention of         Eversana.  Eversana shall also provide Zosano with any and all information about         Payments or Transfers of Value the Sales Force provides to Covered Recipients that         come to the attention of Eversana in connection with this Agreement to the extent         required to enable Zosano to comply with its transparency obligations under Applicable         Law.  All Payments or Transfers of Value made by the Sales Force to Covered Recipients         in connection with this Agreement shall be made in accordance with Applicable Law to a         centrally managed, pre-set rate structure based on a fair market value analysis.          Eversana shall provide to Zosano detailed expenditure information in a manner that         conforms to industry standards, and Eversana shall maintain such documentation for a         minimum of [***].   8.2. Obligation to Notify.  Each Party shall promptly notify the other Party upon becoming       aware of any breach or violation by the Sales Force or by the other Party’s employees with       obligations under this Agreement with respect to the Territory of the Anti-Corruption Laws       and Eversana shall take such steps as the Parties may reasonably agree with respect to       mitigation of any violation or potential violation of the Anti-Corruption Laws by Eversana.     9. INDEPENDENT CONTRACTOR STATUS    9.1. The status of each Party under this Agreement shall be that of an independent contractor.        Except as otherwise expressly set forth herein, neither Party shall have the right to enter                                          22   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          into any agreements on behalf of the other Party, nor shall it represent to any Person that it       has any such right or authority.   9.2. Without limiting Section 9.1, Eversana and its directors, officers, employees, contractors        and any persons providing Services under the Agreement (collectively, “Eversana       Personnel”), which includes without limitation the Sales Force, are at all times independent       contractors with respect to Zosano.  Eversana Personnel are not, and shall not be deemed,       employees of Zosano.  Neither this Agreement nor the Services to be rendered hereunder       shall for any purpose whatsoever or in any way or manner create any employer-employee       relationship between any Eversana Personnel and Zosano or its Affiliates or any of their       directors, officers, agents or employees.  Zosano understands that Eversana may, as set       forth in Section 2.4 above), utilize independent contractors in connection with its       performance of the Services.  Eversana shall retain all Liability associated with the       classification of any such contractors or other Eversana Personnel.   9.3. Eversana is, and at all times shall remain, solely responsible for the human resource and       performance management functions of all Eversana Personnel.  Eversana shall be solely       responsible for complying with all labor and employment laws applicable to Eversana       Personnel, including as relates to hiring, background checks, testing, employment eligibility       verification, classification, compensation, wage and hour matters, taxes, occupational health       and safety, notice, record retention, training, accommodations, benefits, time off work and       leave of absences, medical accommodations, labor relations, privacy, discipline, and       termination.   Eversana shall be solely responsible for all disciplinary, probationary and       termination actions taken with respect to Eversana Personnel, and for the formulation,       content and dissemination of all employment policies and rules (including without limitation       written disciplinary, probationary and termination policies) applicable to Eversana Personnel.   9.4. Eversana shall obtain and maintain worker’s compensation insurance and other insurances       required for Eversana Personnel providing the Services and acknowledges that Zosano       does not, and shall not, have any obligation to obtain or maintain such insurances, all of       which shall be Eversana’s sole responsibility.   9.5. The Parties agree that Eversana Personnel are not, and are not intended to be or be treated       as, employees of Zosano and that no such individual is, or is intended to be, eligible to       participate in any benefits programs or in any Zosano “employee benefit plans” (as defined       in Section 3(3) of ERISA).   9.6. Except as otherwise set out in this Agreement, Zosano shall have no responsibility to       Eversana or any Eversana Personnel for any compensation, expense reimbursements or       benefits (including, without limitation, sick leave, vacation and holiday remuneration, family       or medical leave or benefits, healthcare coverage or insurance, life insurance, pension or       retirement, severance profit-sharing benefits and disability benefits), payroll-related or       withholding taxes, or any governmental charges or benefits (including, without limitation,       unemployment and disability insurance contributions or benefits and workers compensation       contributions or benefits) that may be imposed upon or be related to the performance by       Eversana or Eversana Personnel of the obligations under this Agreement or other labor or       employment-related obligations concerning Eversana Personnel, all of which shall be the       sole responsibility of Eversana.  To clarify, Zosano will not have any right or obligation to       withhold or pay any income tax or payroll tax of any kind on behalf of Eversana.                                          23   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.     9.7. Limitations.  Notwithstanding anything to the contrary in this Section 9, Eversana shall have       no obligation or responsibility for any damages, liability, loss and costs, including without       limitation but not limited to attorney’s fees (collectively, “Liability”) to the extent such Liability       is attributed to either: (i) discriminatory and/or intentional acts of Zosano, its employees,       agents or contractors (other than Eversana Personnel); or (ii) any benefits payable under       any Zosano Benefit Plan, and any other bonus, stock option, stock purchase, incentive,       deferred compensation, supplemental retirement, severance and other similar fringe or       employee benefit plans, programs or arrangements that may be sponsored at any time by       Zosano that are interpreted by any court or Regulatory Authority to cause, any Eversana       Personnel to be reclassified as an employee of Zosano.  In the event any Liability is alleged       against Eversana or its employees which is attributable to Zosano (as set forth in this Section       9.7), Zosano shall indemnify, defend, and hold harmless Eversana and its directors, officers,       employees and contractors.    10.  STATEMENTS, RECORD-KEEPING AND AUDITS   10.1. Zosano Records.  Zosano shall keep complete and accurate books and records (financial       and otherwise), of Net Sales, all regulatory and compliance matters, financial information       necessary to determine reimbursement of costs, Profit Split, and any and all other payments       to be made under this Agreement.  Without limitation of the foregoing, Zosano shall further       keep, or cause to be kept, complete and accurate books and records reflecting all of its       obligations under this Agreement.  Zosano shall keep such books and records or shall cause       such books and records to be kept, for a period of [***] months after the expiration or       termination of this Agreement or such longer period as required by Applicable Law.  All       financial books and records kept by Zosano hereunder shall be maintained in accordance       with GAAP, consistently applied.    10.2. Audits of Zosano.  At the request of Eversana, Zosano shall, and shall cause its Affiliates       to, permit an independent auditor with financial or compliance expertise, as applicable,       designated by Eversana and acceptable to Zosano, at reasonable times and upon       reasonable notice, to audit the books and records maintained pursuant to Section 10.1 to       ensure the accuracy of all reports and payments made hereunder, no more than [***] during       any twelve (12)-consecutive month period during the Term and a period of [***] after the       expiration or termination of this Agreement or such longer period as required by Applicable       Law, and no more than [***] with respect to any period so examined; provided that if any       such audit reveals that Zosano is or was not in material compliance with Applicable Law or       this Agreement, Eversana shall have the right to conduct such additional audits as may be       reasonably required by Eversana to determine whether Zosano has appropriately remedied       such non-compliance.  The cost of any such audit shall be borne by Eversana, unless (a)       with respect to an audit of payments made hereunder, the audit reveals that Eversana has       been underpaid by more than [***] percent ([***]%) of the total it is due for the period in       question, or (b) with respect to an audit of the compliance records, such audit reveals       material and continuous noncompliance by Zosano with Applicable Law, regulatory and       compliance obligations with respect to its obligations under this Agreement, in which case       ((a) or (b)), Zosano shall reimburse Eversana for any third-party costs reasonably incurred       in connection with the audit, up to a maximum of $[***].     10.3. Eversana Records. Eversana shall keep, or shall cause to be kept, complete and accurate       books and records (financial and otherwise) pertaining to the performance of its obligations                                          24   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.        under this Agreement, including without limitation with respect the distribution of the Product      by its 3PL division, hub reimbursement team and Commercialization activities, regulatory      and compliance matters and any other such records as is necessary for calculating Net      Sales, Detail performance and training test results, in sufficient detail to verify compliance      with its obligations hereunder and to calculate and verify all amounts payable hereunder.       Eversana shall keep such books and records or shall cause such books and records to be      kept, for a period of [***] after the expiration or termination of this Agreement or such longer      period as required by Applicable Law.  All financial books and records kept by Eversana      hereunder shall be maintained in accordance with GAAP, consistently applied.   10.4. Audits of Eversana.  At the request of Zosano, Eversana shall, and shall cause its Affiliates      to, permit an independent auditor with financial or compliance expertise, as applicable,      designated by Zosano and acceptable to Eversana, at reasonable times and upon      reasonable notice, to audit the books and records maintained pursuant to Section 10.3 to      ensure Eversana’s compliance with this Agreement, including without limitation the      accuracy of all reports and payments made or costs incurred hereunder, no more than [***]      during any twelve (12)-consecutive month period during the Term and a period of [***] after      the expiration or termination of this Agreement or such longer period as required by      Applicable Law, and no more than [***] with respect to any period so examined; provided      that if any such audit reveals that Eversana is or was not in material compliance with      Applicable Law and the Sales & Promotion Policies with respect to its obligations under this      Agreement, Zosano shall have the right to conduct such additional audits as may be      reasonably required by Zosano to determine whether Eversana has appropriately remedied      such non-compliance.  The cost of any such audit shall be borne by Zosano, unless (a) with      respect to an audit of payments made hereunder, the audit reveals that Eversana has been      overpaid by more than [***] percent ([***]%) of the total owed for the period in question, or      (b) with respect to an audit of the Compliance Records, such audit reveals material and      continuous noncompliance by Eversana with Applicable Law, the Sales & Promotion      Policies with respect to its obligations under this Agreement, in which case ((a) or (b)),      Eversana shall reimburse Zosano for any third-party costs reasonably incurred in      connection with the audit, up to a maximum of $[***].   10.5. Financial Audit Payments.  If any such audit conducted pursuant to Sections 10.2 or 10.4      concludes that additional payments were owed or that excess payments were received      during such period, the owing Party shall pay the additional payments or the receiving Party      shall reimburse such excess payments within [***] days after the date on which such audit      is completed.   11. CONFIDENTIALITY    11.1. Maintaining Confidentiality.  Confidential Information disclosed under this Agreement      shall remain the property of the disclosing Party.  At all times during the Term and for [***]      years following the expiration or termination of this Agreement, the receiving Party shall use      the Confidential Information solely for the purposes set forth in this Agreement and shall not      disclose such Confidential Information to any Third Party except as permitted under this      Agreement or with the disclosing Party’s prior written consent.  The receiving Party shall      use at least the same care for maintaining confidentiality of the Confidential Information as      it uses to maintain the confidentiality of its own Confidential Information of similar value, but      in no event less than commercially reasonable measures within the pharmaceutical industry.                                          25               

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      11.2. Exceptions to Confidentiality.  The receiving Party’s obligations set forth in this       Agreement shall not extend to any Confidential Information of the disclosing Party:        a. that the receiving Party can demonstrate by reasonable evidence was in the receiving         Party’s possession and at its free disposal prior to disclosure by the disclosing Party;        b. that was in the public domain at the time of disclosure by the disclosing Party;        c. that subsequently comes into the public domain through no fault, action or omission of         the receiving Party;        d. that becomes available to receiving Party without any obligation of confidentiality from a         Third Party that is not known to have a confidentiality obligation to the disclosing Party;         or        e. that the receiving Party can demonstrate by reasonable evidence was developed         independently by the receiving Party without use of or reliance on any Confidential         Information of the other Party.   11.3. Authorized Disclosure.  Each Party may disclose Confidential Information to the extent       that such disclosure is:        a. to its directors, officers, employees, advisers, consultants, attorneys, auditors, agents,         contractors, or representatives that reasonably need to know the information for the         purposes set out in this Agreement, and who are subject to confidentiality substantially         as protective as those set forth in this Agreement;        b. to its Affiliates, including without limitation their directors, officers, employees, advisors,         consultants, agents, contractors or representatives, to the extent they reasonably need         to know the information for the purposes set out in this Agreement, and who are subject         to confidentiality obligations substantially as protective as those set forth in this         Agreement;        c. to its legal counsels or auditors to conduct internal checks, assessments or auditing who         need to know the Confidential Information for the purpose of a Party’s internal checks,         assessments or auditing; or        d. as required by laws, rules of public stock exchanges or court orders, provided that the         receiving Party may disclose only such information as is legally required, and provided         further that the receiving Party shall provide the disclosing Party with as much advance         written notice of such requirement as is reasonably practicable under the circumstances         and a reasonable opportunity to object to or limit such disclosure. Notwithstanding the         foregoing, if either Party determines a disclosure of the terms of this Agreement and/or         ancillary documents is required by such law, rule or court order, it shall notify the other         Party in writing at least [***] before the time of the proposed disclosure, to the extent         reasonably practicable under the circumstances.  Without limiting the foregoing, prior to         public disclosure of the terms of this Agreement by either Party pursuant to the rules of a         Government Authority or public stock exchange, such Party shall provide the other Party         with an opportunity to review the proposed publicly filed version of this Agreement and         request that the filing Party seek confidential treatment of sensitive terms that are eligible                                          26   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.          for redaction from such public filing under Applicable Law, which such request the filing        Party shall use reasonable efforts under the circumstances to implement.   11.4. Return or Destruction of Confidential Information.  Upon the effective date of the      expiration or termination of this Agreement for any reason, either Party may request in      writing that the non-requesting Party: (a) promptly destroy all copies of the requesting      Party’s Confidential Information in the possession or control of the non-requesting Party and      confirm such destruction in writing to the requesting Party; or (b) promptly deliver to the      requesting Party, at the non-requesting Party’s sole cost and expense, all copies of such      Confidential Information in the possession or control of the non-requesting  Party.       Notwithstanding the foregoing, the non-requesting Party shall be permitted to retain such      Confidential Information (i) to the extent necessary or useful for purposes of performing any      continuing obligations or exercising any ongoing rights hereunder and, in any event, a single      copy of such Confidential Information for archival purposes and (ii) any computer records      or files containing such Confidential Information that have been created solely by such non-     requesting Party’s automatic archiving and back-up procedures, to the extent created and      retained in a manner consistent with such non-requesting Party’s standard archiving and      back-up procedures, but not for any other uses or purposes.  All retained Confidential      Information shall continue to be subject to the terms of this Agreement for the period set      forth in Section 11.1.   11.5. Use of Name and Disclosure of Terms.         a. Except as necessary to perform a Party’s obligations under this Agreement, each Party        (a) shall keep the existence, terms, and the subject matter (including without limitation        the applicable transactions) covered by this Agreement confidential and shall not disclose        such information to any other Person through a press release or otherwise and (b) shall        not mention or otherwise use the name or any trademark of the other Party or its Affiliates        in connection with this Agreement, in each case ((a) and (b)), without the prior written        consent of the other Party in each instance (which shall not be unreasonably withheld,        conditioned or delayed).  Notwithstanding the foregoing, (i) the restrictions imposed by        this Section 11.5 shall not prohibit either Party from making any disclosure identifying the        other Party that is required by Applicable Law or the requirements of a national securities        exchange or another similar regulatory body, provided that any such disclosure shall be        governed by Section 11.3, and (ii) the restrictions imposed by this Section 11.5 shall not        prohibit either Party from announcing this Agreement to the public promptly following the        Effective Date, including without limitation such key terms and other items appropriate for        such a public release, in each case subject to the written consent of the other Party, which        shall not be unreasonably withheld.  Further, the restrictions imposed on each Party under        this Section 11.5 are not intended, and shall not be construed, to prohibit a Party from (x)        identifying the other Party in its internal business communications, provided that any        Confidential Information in such communications remains subject to this Article 11 or (y)        disclosing (i) information for which consent has previously been obtained and (ii)        information of a similar nature to that which has been previously disclosed publicly with        respect to this Agreement, each of which ((i) and (ii)) shall not require advance approval,        but copies of which shall be provided to the other Party as soon as practicable after the        release or communication thereof.                                                        27               

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      b.   If this Agreement and/or any Statement of Work executed by the Parties is considered a        “material contract” for either Party requiring such Party to disclose this Agreement (and/or        any Statement of Work) in its filings with the Securities and Exchange Commission (“SEC”),         the applicable Party shall provide the other Party with an opportunity to review the        proposed filing with the SEC (for a period not to exceed [***]) and request redactions to        protect non-public proprietary information of the other Party from being disclosed publicly        (which request the applicable Party shall use reasonable efforts to seek unless advised by        its counsel that such information must be disclosed under law).    12.  REPRESENTATIONS AND WARRANTIES   12.1. Mutual Representations and Warranties.  Each Party represents and warrants to the       other Party that as of the Effective Date:          a. It is an independent legal entity duly organized, validly existing in good standing under         the laws of the place of its establishment or incorporation;        b. it has full authority to enter into this Agreement and to perform its obligations under this         Agreement and the provisions of this Agreement are legally binding upon it from the         Effective Date;        c. its execution of this Agreement and performance of its obligations under it will not violate         (i) any provision of its business license, articles of incorporation, articles of association or         similar organizational documents; (ii) any Applicable Laws or any governmental         authorization or approval; and (iii) any contract to which it is a party or to which it is subject,         or result in a default under any such contract;        d. no lawsuit, arbitration or other legal or governmental proceeding is pending or, to its         knowledge, threatened against it that would affect its ability to perform its obligations         under this Agreement;        e. it has disclosed to the other Party all documents received from any Governmental         Authority or Regulatory Authority that may have a material adverse effect on its ability to         fully perform its obligations under this Agreement;          f. it has not been debarred and is not subject to debarment and that it shall not knowingly         use in any capacity, in connection with the Services and the program described herein,         any Person who has been debarred pursuant to Section 306 of the Act or who is the         subject of a conviction described in such section;         g. (i) it and its Affiliates are in compliance with (A) the PhRMA Code on Interactions with         Healthcare Professionals and (B) all state codes or requirements that limit or regulate         interactions with healthcare practitioners and (ii) it has not been debarred, suspended or         excluded from any federal health care program, including without limitation Medicare,         Medicaid and the Civilian Health and Medical Program of the Uniformed Services.  If it or         any of its employees who are involved in performing the Services or working with the         other Party in connection with the program described herein, is debarred, suspended or         excluded during the Term or such Party reasonably believes debarment, suspension or         exclusion is contemplated, it shall immediately notify the other Party in writing upon it         becoming aware of such debarment, suspension or exclusion.  If a Party is so debarred,                                          28   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.            suspended or excluded, or in the case of any employee who is debarred, suspended or         excluded, if the applicable Party permits such employee to continue to perform any         Services or work on the program described herein, then the other Party shall have the         right to terminate this Agreement upon written notice to the other Party.  Any termination         of this Agreement pursuant to this Section 12.1.g. shall be treated as a termination         pursuant to Section 14.2.e. as if such Party had committed a material breach, except that         in such event no cure period shall apply, and such Party shall have the right to effect such         termination immediately upon written notice to other Party; and        h. it will comply in all material respects with Applicable Laws in performing its obligations         and exercising its rights hereunder.   12.2. Zosano’s Representations and Warranties.  Zosano represents and warrants that as of       the Effective Date:         a. Zosano has no knowledge of any claim alleging that the manufacture, packaging,         distribution, sale or use of the Product in the Territory, or that the use of any registered         trademark or registered copyright within the Product Trademarks, Corporate Trademarks         or Product Copyrights, infringes or misappropriates the Intellectual Property Rights or         other rights of any Third Party;         b.  to Zosano’s knowledge, the manufacture, packaging, distribution, sale or use of the         Product in the Territory and the use of any registered Trademark or Corporate         Trademarks in the Territory does not infringe or misappropriate the Intellectual Property         Rights or other rights of any Third Party; and        c. to Zosano’s knowledge, the manufacture, packaging, distribution, sale or use of the         Product in the Territory and the use of any registered copyright within the Product         Trademarks, or Product Copyrights in the Territory does not infringe or misappropriate         the Intellectual Property Rights or other rights of any Third Party.   12.3. Eversana’s Representations and Warranties.  Eversana represents and warrants that as       of the Effective Date:         a. it has adequate cash flow and otherwise has the financial resources, capacity and         capabilities to timely and adequately perform its obligations hereunder;        b.  Eversana has no knowledge of any claim alleging that the use of Eversana IP in         connection with the Services and the Product in the Territory infringes or misappropriates         the Intellectual Property Rights or other rights of any Third Party; and        c.  to the knowledge of Eversana, any use of Eversana IP in connection with the Services         and the Product in the Territory does not infringe or misappropriate the Intellectual         Property Rights or other rights of any Third Party.    12.4. Covenant.          a. Each party shall, and cause its Affiliates, employees, and agents, to comply with         Applicable Laws in connection with its obligations and responsibilities hereunder.                                          29   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          b. Eversana will not use any marketing, educational, promotional or training materials in the         course of performing activities under this Agreement other than those reviewed and         approved by Zosano;        c. Without limiting Eversana’s other obligations in this Agreement, Eversana will comply with         its obligations under Sections 2.2.b, 2.3.a and 9.2 through 9.6.            d. Zosano is solely responsible for reviewing, finalizing and approving all Product         Promotional Materials and literature (including but not limited Product inserts and all         Product Promotional Materials initially prepared by Eversana) and for ensuring all such         materials comply with Applicable Law.          12.5. DISCLAIMER OF WARRANTIES.  EXCEPT FOR THE EXPRESS WARRANTIES SET       FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY       WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW,       BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY       OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED,       INCLUDING WITHOUT LIMITATION ANY WARRANTY OF QUALITY, MERCHANTABILITY       OR FITNESS FOR A PARTICULAR USE OR PURPOSE.   13.  INDEMNIFICATION, LIMITATION OF LIABILITY AND INSURANCE    13.1. Zosano Indemnity.  Zosano shall indemnify, hold harmless and defend Eversana, its       Affiliates, and their respective directors, officers, employees, representatives and agents       (the “Eversana Indemnitees”) from and against any and all losses, damages, liabilities,       judgments, fines, and amounts paid in settlement, including without limitation any       associated costs and expenses (including without limitation reasonable attorneys’ fees)       (“Losses”), which result directly or indirectly from any claim, demand, suit, action or       proceeding brought or initiated by a Third Party against them (“Claims”) to the extent that       such Claims arise out of (i) the manufacture, packaging, branding, labeling, sale or use of       the Product, including without limitation any death or personal injury arising out of the       defective manufacture of the Product by or on behalf of Zosano, (ii) any product liability or       similar claims with respect to the Product (regardless of legal theory including but not limited       to strict liability), (iii) any actual or asserted violation of the Federal Food, Drug and Cosmetic       Act or any other Applicable Law by virtue of which the Product is alleged or determined to       be adulterated, misbranded, mislabeled or otherwise not in full compliance with Applicable       Law; (iv) infringement or misappropriation of the Intellectual Property Rights of a Third Party       through the conduct of Services or use of the Product Copyrights or Product Trademarks in       connection therewith, except to the extent such infringement or misappropriation relates to       the use of the Eversana IP; or (v) the gross negligence, fraud or willful misconduct of any of       the Zosano Indemnitees in performing any obligations under this Agreement; or (vi) a breach       of a representation, warranty or covenant set forth in this Agreement by a Zosano       Indemnitee; provided, however, with respect to Section 13.1(iv) – Section 13.1 (vi) Zosano       shall not be required to indemnify, hold harmless or defend any Eversana Indemnitee       against any claim to the extent that Eversana has an obligation to indemnify an Zosano       Indemnitee under Section 13.2.    13.2. Eversana Indemnity.  Eversana shall indemnify, hold harmless and defend the Zosano, its       Affiliates, and their respective directors, officers, employees, representatives and agents                                         30   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.        (the “Zosano Indemnitees”) from and against any Losses, which result directly or indirectly      from any Claims to the extent that such Claims arise out of: (i) the gross negligence, fraud      or willful misconduct of any of the Eversana Indemnitees in performing any obligations under      this Agreement, (ii) any infringement of the Intellectual Property Rights of a Third Party      predicated on Eversana IP;  or (iii) a breach of a representation,  warranty or covenant set      forth in this Agreement by an Eversana indemnitee; provided, however, that Eversana shall      not be required to indemnify, hold harmless or defend any Zosano Indemnitee against any      claim to the extent that Zosano has an obligation to indemnify a Eversana Indemnitee under      Section 13.1.     13.3. Zosano Reimbursement of Certain Expenses.  Zosano shall reimburse Eversana for [***]      and Eversana employee [***] in connection with any of the following events or occurrences,      [***] of its express obligations contained in this Agreement:  (i)  [***]; or (ii) [***].   13.4. Procedures.  Any indemnified party submitting an indemnity claim under this Section 13,      as applicable (“Indemnified Party”) shall: (a) promptly notify the indemnifying Party      (“Indemnifying Party”), of such claim in writing and furnish the Indemnifying Party with a      copy of the applicable communication, notice or other action relating to the event for which      indemnity is sought; provided that, no failure to provide such notice pursuant to this clause      (i) shall relieve the Indemnifying Party of its indemnification obligations, except to the extent      such failure materially prejudices the Indemnifying Party’s ability to defend or settle the claim;      (ii) give the Indemnifying Party the authority, information and assistance necessary to      defend or settle such suit or proceeding in such a manner as the Indemnifying Party shall      determine; and (iii) give the Indemnifying Party sole control of the defense (including without      limitation the right to select counsel, at the Indemnifying Party’s expense) and the sole right      to compromise and settle such suit or proceeding; provided, however, that in the case of      the foregoing clauses (ii) and (iii), the Indemnifying Party shall not, without the written      consent of the Indemnified Party, compromise or settle any suit or proceeding unless such      compromise or settlement (x) is solely for monetary damages (for which the Indemnifying      Party shall be responsible), (y) does not impose injunctive or other equitable relief against      the Indemnified Party and (z) includes an unconditional release of the Indemnified Party      from all liability on claims that are the subject matter of such proceeding.  The Indemnified      Party (in its capacity as such) may participate in the defense at its own expense.   13.5. Limitation of Liability.  NOTWITHSTANDING ANYTHING TO THE CONTRARY      CONTAINED IN THIS AGREEMENT, TO THE FULLEST EXTENT PERMITTED BY      APPLICABLE LAW AND EXCEPT AS A RESULT OF GROSS NEGLIGENCE, COMMON      LAW FRAUD OR WILLFUL MISCONDUCT, A BREACH OF ARTICLE 11       OR SECTION      2.2.b OR IN CONNECTION WITH A PARTY’S INDEMNIFICATION OBLIGATIONS SET      FORTH HEREIN, NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE TO      THE OTHER OR THEIR AFFILIATES, FOR ANY CLAIMS, DEMANDS OR SUITS FOR      CONSEQUENTIAL, SPECIAL, EXEMPLARY, PUNITIVE, INDIRECT OR MULTIPLE      DAMAGES, OR FOR LOSS OF PROFITS, REVENUE OR INCOME, DIMINUTION IN      VALUE OR LOSS OF BUSINESS OPPORTUNITY (IN EACH CASE, WHETHER OR NOT      FORESEEABLE AT THE EFFECTIVE DATE) OR ANY DAMAGES CALCULATED BY      REFERENCE TO A MULTIPLIER OF REVENUE, PROFITS, OR SIMILAR      METHODOLOGY, CONNECTED WITH OR RESULTING FROM ANY BREACH OF THIS      AGREEMENT, OR ANY ACTIONS UNDERTAKEN IN CONNECTION WITH, OR RELATED      HERETO, INCLUDING WITHOUT LIMITATION ANY SUCH DAMAGES WHICH ARE                                         31               

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          BASED UPON BREACH OF CONTRACT, TORT, BREACH OF WARRANTY, STRICT       LIABILITY, STATUTE, OPERATION OF LAW OR ANY OTHER THEORY OF RECOVERY.        EACH PARTY FURTHER ACKNOWLEDGES AND AGREES THAT UPON ANY BREACH       OF A WARRANTY BY A PARTY CONTAINED HEREIN, EXCEPT TO THE EXTENT SUCH       BREACH IS A RESULT OF SUCH PARTY’S GROSS NEGLIGENCE, COMMON LAW       FRAUD OR WILLFUL MISCONDUCT, OR ARISES IN CONNECTION WITH SUCH       PARTY’S INDEMNIFICATION OBLIGATIONS SET FORTH HEREIN,       SUCH PARTY’S       MAXIMUM LIABILITY TO THE OTHER PARTY FOR DAMAGES SHALL IN NO EVENT       EXCEED THE SUM OF ALL PAYMENTS ACTUALLY RECEIVED FROM OR PAID BY THE       OTHER PARTY DURING THE SIX (6) MONTH PERIOD IMMEDIATELY PRECEDING THE       DATE THE PARTY’S CLAIM AROSE”, PROVIDED THAT DURING THE ONE (1) YEAR       PERIOD COMMENCING UPON THE EFFECTIVE DATE, THE MAXIMUM           LIABILITY       SHALL BE [***] DOLLARS ($[***]) [***] AND DURING THE [***] OF THE EFFECTIVE DATE,       THE MAXIMUM LIABILITY SHALL BE [***] DOLLARS ($[***]) [***].    13.6. Insurance.  Each Party shall at all times maintain general liability insurance policies or self-      insurance in such amounts and with such scope of coverage as are normal and customary       in the pharmaceutical industry for a Person of comparable size and engaged in activities       comparable to the activities in which such Party engages hereunder.  As of the NDA       Approval Date, Zosano shall maintain Product Liability insurance of at least [***] dollars       ($[***]) (and increasing to [***] dollars ($[***]) prior to Commercial Launch) naming Eversana       as an additional insured under such policy, it being understood and agreed that Eversana       shall not need to obtain any product liability insurance during the Term.  If requested by the       other Party, the insured Party shall furnish a certificate of insurance or other reasonable       proof of coverage (which may be a certificate or other evidence issued by a Party under a       program of self-insurance) evidencing the requisite coverage required under this Section       13.6 during the Term.  The insurance policies shall be under an occurrence form, but if only       a claims-made form is available to a Party, then such Party shall continue to maintain such       insurance after the expiration or termination of this Agreement for a period of [***] years.   14.  TERM AND TERMINATION   14.1. Term.  The Agreement shall take into effect as of the Effective Date and shall remain in       effect for a term of five (5) years after the NDA Approval Date unless earlier terminated as       provided hereunder (the “Term”).   14.2. Termination. This Agreement may be terminated as follows:        a. Termination for Delays in Providing Pre-Commercial and Commercial Plans and         Budgets.  Zosano shall have the right to terminate this Agreement immediately upon         written notice to Eversana if Eversana does not provide the initial (i) Pre-Commercial Plan         and Pre-Commercial Budget to the Committee for review and approval within seventy-        five (75) days of the Effective Date or (ii) the initial Commercial Plan and Commercial         Budget for review and approval within ninety (90) days of the Effective Date.                      b. Termination for Late Approval.  Either Party shall have the right to terminate this         Agreement if NDA Approval does not occur by July 31, 2021 effectively upon providing         written notice to the other Party within sixty (60) days after such date (such notice to be         effective upon receipt thereof by the other Party).                                           32   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.              c. Termination for Discontinuance of Product Commercialization in the Territory.         Zosano may, in its sole discretion, decide to discontinue its development or        Commercialization efforts for the Product in the Territory, and in connection therewith,        may terminate this Agreement upon sixty (60) days prior written notice provided to        Eversana. In the event Zosano terminates the Agreement pursuant to this Section 14.2c.        during the first [***] from the Effective Date, Zosano shall pay Eversana an early        termination fee in an amount equal to [***] percent ([***]%) of the Commercialization Fees        actually incurred by Eversana up to the termination date and not previously reimbursed        to Eversana.                     d. Termination for Revenue Shortfall.  Each Party shall be entitled to terminate the        Agreement if cumulative Net Profits are negative in at least [***] commencing upon or        after the date that is [***] after the Commercial Launch, by providing the other Party with        thirty (30) days’ prior written notice, provided that such condition is not directly attributable        to breach by the terminating Party of its obligations under this Agreement.            e. Termination upon Material Breach.  Either Party may terminate this Agreement by        written notice to the other Party if the other Party materially breaches this Agreement,        and such breach is not cured within sixty (60) days after the other Party receives written        notice of such breach from such Party specifying in detail the nature and extent of the        alleged material breach.  Such termination shall be effective upon a subsequent written        notice from such Party after expiration of the foregoing sixty (60) day period.       f. Termination for Insolvency.  Either Party may terminate this Agreement immediately on        written notice if the other Party (or, if applicable, a parent of such other Party) shall file in        any court or Governmental Authority, pursuant to any statute or regulation of any state or        country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement        or for the appointment of a receiver or trustee of the other Party or of its assets, or if the        other Party (or, if applicable, a parent of such other Party) shall be served with an        involuntary petition against it, filed in any insolvency proceeding, and such petition shall        not be dismissed within sixty (60) days after the filing thereof, or if the other Party (or, if        applicable, a parent of such other Party) shall propose or be a party to any dissolution or        liquidation, or if the other Party (or, if applicable, a parent of such other Party) shall make        a general assignment for the benefit of its creditors.       g. Termination for Change of Control.  In the event of a Change of Control of Zosano,        Zosano will make reasonable efforts to ensure that such Third Party (“Acquiring Party”)        will continue to utilize the Services of Eversana for the remainder of the Term.         Notwithstanding the prior sentence, Zosano shall have the right to terminate this        Agreement upon entering into a definitive binding agreement for a Change of Control of        Zosano upon sixty (60) days advance written notice provided to Eversana, such notice to        be provided to Eversana at any time within the [***] day period following the effective date        of such Change of Control. [***] Eversana shall also receive all payments due in        accordance with Section 14.6 below. Any termination payment owed under this Section        14.2.g would be reduced by the amount of previously reimbursed Commercialization        Fees and Profit Split share payments paid for the relevant twelve (12) month period.        h. Termination for Recall; Failure to Launch.  Either Party may terminate this Agreement                                         33               

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.            upon ninety (90) days written notice to the other Party if:          (i) the Product is subject to a recall in the Territory based on material safety concerns for            the Product, which shall not include any recall for packaging or labeling issues,            manufacturing concerns, or the like; or          (ii) the Product is not Commercially Launched within [***] of the NDA Approval Date,            other than by reason of the terminating Party’s failure to perform its obligations under            this Agreement, provided that a written notice of termination is given within sixty (60)            days of the end of the [***] month period.         i. Termination for Product Withdrawal.  Eversana can terminate this Agreement upon         thirty (30) days written notice to Zosano if: (i) Zosano withdraws the Product from the         market in the Territory for a period of greater than ninety (90) days, provided that a written         notice of termination is given within sixty (60) days after the expiration of such ninety (90)         day Product withdrawal period.    14.3. Effect of Termination or Expiration.         a. Upon the effective date of expiration or termination of this Agreement, and subject to         Section 14.3.b below, Eversana shall promptly cease all performance of the Services and         promptly discontinue the use of any Zosano IP, Arising Product IP, Product Trademarks,         Product Copyrights, and Corporate Trademarks.  At Zosano’s election, Eversana either         shall (a) promptly return to Zosano or (b) destroy and certify to Zosano such destruction         of, all Promotional Materials, training materials, and all other information and materials         related to the Product or the activities provided for by this Agreement.        b. Except as otherwise expressly provided herein, termination of this Agreement in         accordance with the provisions hereof shall not limit any remedies that may otherwise be         available in law or equity.     14.4. Accrued Rights.  Termination or expiration of this Agreement for any reason shall be       without prejudice to any rights that shall have accrued to the benefit of a Party prior to such       termination or expiration, including, without limitation, Eversana’s rights to any amounts       owed by Zosano hereunder and pursuant to the Loan Agreement. Such termination or       expiration shall not relieve a Party from obligations that are expressly indicated to survive       the termination or expiration of this Agreement.      14.5. Loan Agreement.  On termination or expiration of this Agreement for any reason, Zosano       shall owe Eversana all amounts due pursuant to the Loan Agreement, in accordance with       the terms set forth in the Loan Agreement.  For clarification, there are no circumstances       pursuant to which Zosano shall not repay Eversana for all amounts loaned by Eversana to       Zosano, pursuant to the Loan Agreement.   14.6. Payments Due Eversana Upon Termination.  In addition to other payment obligations set       forth in this Agreement due on termination, in the event of termination of this Agreement:       Zosano shall reimburse or pay Eversana for:         a. [***] percent ([***]%) of all Commercialization Fees owed by Zosano to Eversana as of          the date termination it;                                           34   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          b. Eversana’s share of the any remaining positive Profit Split not already paid and due as          of the effective date of termination.        c. Fees and expenses incurred (or to be incurred by Eversana following termination) for          work to be provided by Third Parties and other related commitments entered into by          Eversana pursuant to written agreements existing at the time of termination in          connection with the Services that could not be terminated; provided Eversana uses          reasonable efforts to mitigate such costs and expenses incurred.             d. the following expenses actually incurred by Eversana (or to be incurred by Eversana)          related to fleet automobiles provided to members of the Sales Force and supported by          reasonable documentation:                (i) a [***] early termination fee (if any); and                 (ii) a [***] in the amount equal to the net loss to Eversana on such [***] determined          by deducting the [***], as of date the [***] is returned to Eversana's [***] provider, [***];          and                   (iii) all remaining [***] by Eversana between the [***]; and                 (iv) [***] by Eversana.    14.7. Survival.  The rights and obligations of the Parties set forth in Section 1 (Definitions),       Section 2.3.a (Other Rights and Obligations), Section 2.7 (Non-Solicitation), Section 6.1       (Ownership of Regulatory Documentation and Approvals), Section 8.1.c (Eversana       Compliance with Laws and Policies), Section 10 (Statement, Record-keeping and Audits),       Section 11 (Confidentiality), Section 13 (Indemnification, Limitation of Liability and       Insurance), Section 14.3 (Effect of Termination), Section 14.4 (Accrued Rights), Section       14.5 (Loan Agreement), Section 14.6 (Payments on Termination), Section 14.7 (Survival),       Section 15 (Notice), and Section 16 (General Provisions) shall survive the termination or       expiration of this Agreement.     15. NOTICE             Any notice or written communication provided for in this Agreement by a Party to the       other Party, including without limitation but not limited to any and all offers, writings, or       notices to be given hereunder, shall be made by registered mail or by courier service       delivered letter, promptly transmitted or addressed to the appropriate Party.  The date of       receipt of a notice or communication hereunder shall be the date of delivery confirmed by       the USPS or the courier service in the case of a courier service delivered letter.  All notices       and communications shall be sent to the appropriate address set forth below, until the same       is changed by notice given in writing to the other Party effective as above.          Notice to Zosano:       [***]               Address:          Zosano Pharma Corporation                                 34790 Ardentech Court                                  Fremont, California 94555                                          35   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.                                                          With a copy to:         Latham and Watkins LLP                                  140 Scott Drive, Menlo Park, CA, 94025                                 Attention: [***]                                                                                                                                    Notice to Eversana:        [***]              Address:             EVERSANA Life Science Services, LLC                                 190 N. Milwaukee Street                                 Milwaukee, WI 53202                                            With a copy to:          [***]                                 EVERSANA Life Science Services, LLC                                 190 N. Milwaukee Street                                 Milwaukee, WI 53202                                        16.  GENERAL PROVISIONS   16.1. Force Majeure.  Except as otherwise set out in this Agreement, no Party to this Agreement       shall have any liability whatsoever or (without prejudice to any payments of monies due) be       deemed to be in default for any delays or failures in performance of any of its obligations       under this Agreement to the extent such delay or failure is caused by or results from causes       beyond the reasonable control of the affected Party, potentially including without limitation,       pandemics. embargoes, war, acts of war (whether war be declared or not), acts of terrorism,       insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire,       floods, or other acts of God, or acts, omissions or delays in acting by any governmental       authority (including without limitation government shut down) or the other Party.  The       affected Party shall notify the other Party of such force majeure circumstances as soon as       reasonably practical. The affected Party shall use all reasonable endeavors to remedy the       event or limit the effects of the said event of force majeure upon the other Party in a timely       manner.  When such circumstances arise, the Parties shall negotiate in good faith any       modifications of the terms of this Agreement that may be necessary or appropriate in order       to arrive at an equitable solution.  If any force majeure event continues for a period of at       least [***] days that would prevent the performance of any material obligation of or receipt       of any material benefit (including, without limitation, payment) by a Party under this       Agreement, the affected Party shall have the right to terminate this Agreement upon thirty       (30) days written notice to the other Party.    16.2. Governing Law.  This Agreement shall in all respects be governed by and interpreted       according to the laws of Delaware and the United States without regard to or application of       conflict-of-law rules or principles.   16.3. Integrity.  This Agreement together with the Exhibits attached hereto constitutes the entire       agreement between the Parties relating to the subject matter hereof and supersedes all       prior agreements, understandings and discussions, whether oral or written, of the Parties       with respect to the subject matter hereof.  Any modification of this Agreement shall be       effective only when made in writing and signed and delivered by the Parties.                                           36   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.      16.4. Assignability.  Neither Party may assign this Agreement without the consent of the other       Party, except either Party may assign this Agreement in whole or in part to any Affiliate of       such Party without the consent of the other Party.  Further, either Party may assign this       Agreement, and all of its rights and obligations, without the consent of the other Party, to its       successor in interest by way of merger, acquisition, or sale of all or substantially all of its       business or assets; provided that, the assigning Party provides the other Party with written       notice of such assignment within [***] days after such assignment, merger, acquisition or       sale.    16.5. Severability.  If any provision contained in this Agreement shall, for any reason, be held       invalid, illegal or unenforceable, such invalidity, illegality or unenforceability shall not affect       any other provision of this Agreement, but this Agreement shall be construed by limiting       such invalid, illegal or unenforceable provision, or if such is not possible, by deleting such       invalid, illegal or unenforceable provision from this Agreement; provided that (i) such       provision shall be deemed to be replaced by a provision which achieves the original intent       of the Parties to the fullest extent possible; (ii) should this Agreement as a result of such       deleting no longer reflect the good faith intent of the Parties, either Party may propose       amendments to the other provisions of this Agreement in order to have the Agreement       correspond to such good faith intent and the Parties shall negotiate in good faith on such       amendments.   16.6. Waiver.  No course of dealing or failing of either Party to strictly enforce any term, right or       condition of this Agreement in any instance shall be construed as a general waiver or       relinquishment of such term, right or condition. Such waiver or relinquishment (either       generally or any given instance and either retroactively or prospectively) shall only be       effective if made expressly in writing by the Party with reference to the specific term, right       or condition.   16.7. No Third Party Rights.  The provisions of this Agreement are for the sole benefit of the       Parties, their successors and permitted assignees, and they shall not be construed as       conferring any rights in any other Persons except as otherwise expressly provided in this       Agreement.   16.8. Headings.  The descriptive headings in this Agreement are for convenience only and shall       not be interpreted so as to limit or affect in any way the meaning of the language in the       pertaining article, section, paragraph or sub-paragraph.   16.9. Costs and Expenses.  Each Party shall, unless specifically otherwise agreed hereunder,       bear their own costs and expenses connected with such Party’s activities and performance       under this Agreement.   16.10. Counterparts.  This Agreement may be executed in two (2) counterparts, each of which       shall be deemed an original, but all of which together shall constitute one and the same       instrument.  This Agreement may be executed by facsimile or electronically transmitted       signatures and such signatures shall be deemed to bind each Party hereto as if they were       original signatures.                                                                           37   

 

 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item   601(b)(10).  Such excluded information is not material and would likely cause competitive harm   to the registrant if publicly disclosed.          IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their   duly authorized representatives as of the Effective Date.        Zosano Pharma Corporation       By:  /s/ Steven Lo________________________________                   Name:  Steven Lo  Title:  President & Chief Executive Officer        Eversana Life Science Services, LLC       By:  /s/ Gregory Skalicky________________________________                   Name:   Gregory Skalicky   Title:   Chief Revenue Officer                                                                      38   

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.                                      EXHIBIT A                            PRE- COMMERCIAL SERVICES                                                           Omitted pursuant to Regulation S-K, Item 601(a)(5).                                                          39               

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.                                      EXHIBIT B                        LAUNCH and COMMERCIAL SERVICES                    Omitted pursuant to Regulation S-K, Item 601(a)(5).                                                          40               

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.                                      EXHIBIT C                               FUNCTIONAL SERVICES                    Omitted pursuant to Regulation S-K, Item 601(a)(5).                                                                   41               

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.                                      EXHIBIT D                              CORPORATE FUNCTIONS                    Omitted pursuant to Regulation S-K, Item 601(a)(5).                                         42               

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.                                      EXHIBIT E                               Initial Alliance Managers      For Zosano Pharma, Inc.:         [***]        For Eversana, Inc.:        [***]                                            43               

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item  601(b)(10).  Such excluded information is not material and would likely cause competitive harm  to the registrant if publicly disclosed.                                       Exhibit F   Terms and Conditions to be incorporated into the Loan Agreement       •  [***]                                                                44November 11, 2020

 

Altium Growth Fund, LP

152 West 57th Street, 20th Floor

New York, NY 10019

Attn: Josh Thomas, Portfolio Manager

 

Gentlemen:

 

Reference is made to
the Securities Purchase Agreement dated April 23, 2020 (the “Purchase Agreement”) between Immunic, Inc.,
a Delaware corporation (the “Company”), and each purchaser identified on the signature pages thereto
(each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”).
Pursuant to the Purchase Agreement, the Purchasers purchased 1,764,706 shares of the Company’s common stock (the “Shares”).
Capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Purchase Agreement.

 

Section 4.9 of the
Purchase Agreement provides that from April 27, 2020 and until April 27, 2021 the Company will provide the Purchasers with the
opportunity to participate in up to 20% of certain subsequent financings of the Company during this time period (the “Financing
Participation Right”). The Company is asking the Purchasers to execute this letter to acknowledge and agree and to
amend Section 4.9(h) of the Purchase Agreement such that the Company may engage in “at the market offerings” pursuant
to its existing Sales Agreement with SVB Leerink LLC, dated as of July 17, 2019 (the “SVBL Sales Agreement”)
without any requirement to offer the Purchasers the right to purchase any portion of any equity securities sold by the Company
pursuant the SVBL Sales Agreement and, thus, that the Financing Participation Right shall not apply to sales under the SVBL Sales
Agreement.

 

By executing this letter
below, pursuant to Section 5.5 of the Purchase Agreement, the Purchasers holding at least 50.1% in interest of the Shares hereby
agree with the Company that this letter shall be deemed to amend Section 4.9(h) of the Purchase Agreement to explicitly exclude
shares of common stock of the Company sold pursuant to the SVBL Sales Agreement from the Financing Participation Right. As such,
Section 4.9(h) shall be amended and restated in its entirety to read as follows:

 

“Notwithstanding
the foregoing, this Section 4.9 shall not apply in respect of (i) an Exempt Issuance and (ii) issuances and sales of Common Stock
pursuant to that certain Sales Agreement, by and between the Company and SVB Leerink LLC, dated as of July 17, 2019.”

 

In exchange for the
amendment above, the term of the Participation Right will be extended to May 26, 2021.

 

     

     

    

 

Except as set forth
herein, the Purchase Agreement shall remain in full force and effect and unmodified, enforceable in accordance with its terms,
including, but not limited to Section 4.10 of the Purchase Agreement.

 

Section 5.9 (Governing
Law) of the Purchase Agreement is hereby incorporated into this letter. This letter may be executed and delivered in counterparts,
each of which, when so executed and delivered, shall be deemed an original and all of which taken together shall constitute one
and the same original agreement. This letter may be signed by any one or more of the parties by .pdf or facsimile transmission,
any such .pdf or facsimile transmission to be treated for all purposes as an original.

 

	 	Very truly yours,
	 	 
	 	/s/ Duane Nash
	 	 
	 	Immunic, Inc.
	 	Duane Nash
	 	Executive Chairman of the Board
	 	 
	Acknowledged and Agreed:	 
	 	 
	Altium Growth Fund, LP	 
	 	 
	By: /s/ Mark Gottlieb	 
	       Name: Mark Gottlieb	 
	       Title: Authorized Signatory

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00317-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00317-of-00352.parquet"}]]