Document:

EX-10.28

  Execution Version

  CONFIDENTIAL

  Exhibit 10.28

    

  CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO SUTRO BIOPHARMA, INC. IF PUBLICLY DISCLOSED.

   

  OPTION AND LICENSE AGREEMENT

  THIS OPTION AND LICENSE AGREEMENT (this “Agreement”), entered into as of October 9, 2021 (the “Effective Date”), is entered into by and between BioNova Pharmaceuticals Limited, a company incorporated under the laws of Hong Kong, having its registered office at Unit 417, 4th floor, Lippo Centre Tower Two, No. 89 Queensway Admiralty, Hong Kong (“BioNova”), and Sutro Biopharma, Inc., with its headquarters at 111 Oyster Point Boulevard, South San Francisco, CA 94080, U.S.A. (“Sutro”).

  INTRODUCTION

  WHEREAS, BioNova wishes to obtain from Sutro and Sutro wishes to grant to BioNova certain rights and licenses under intellectual property owned or controlled by Sutro to Develop, Manufacture and Commercialize Licensed Products in the Field in the Territory (each as defined below), subject to the terms and conditions set forth herein.

  NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:

  ARTICLE I
DEFINITIONS

  Unless the context clearly indicates otherwise, the following terms used in this Agreement will have the meanings set forth in this ARTICLE I: 

  Section I.1.“Abandoning Party” has the meaning set forth in Section 9.2(c).

  Section I.2. “Accounting Standards” means, with respect to a Person, generally accepted accounting principles (“GAAP”) as practiced in a jurisdiction where a Party conducts its business, International Financial Reporting Standards (“IFRS”), or applicable international standards followed by such Person. 

  Section I.3.“Acquired Competing Product” has the meaning set forth in Section 3.9(c).

  Section I.4.“Action” means any claim, action, cause of action or suit (whether in contract or tort or otherwise), litigation (whether at law or in equity, whether civil or criminal), assessment, 

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  arbitration, investigation, hearing, charge, complaint, demand, notice or proceeding of, to, from, by or before any Governmental Authority. 

  Section I.5.“Active Ingredient” means those active materials that provide pharmacological activity in a pharmaceutical or biologic product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies). Drug delivery vehicles, adjuvants and excipients will not be deemed to be Active Ingredients.

  Section I.6.“ADC” means an antibody drug conjugate whereby [*]

  Section I.1.“Adverse Event” or “AE” has the meaning set forth in the PRC Measures for the Administration of Reporting and Surveillance of Drug Adverse Events (effective as of July 1, 2011) or the equivalent applicable Laws in any relevant Region, and generally means any untoward medical occurrence associated with the use of a product in human subjects, whether or not considered related to such product. An AE does not necessarily have a causal relationship with a product, that is, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of such product. 

  Section I.2.“Affiliate” means, with respect to any specified Person, any other Person that controls, is controlled by, or is under common control with such first Person. For purposes of this definition only, “control” means (a) to possess, directly or indirectly, the power to direct or cause the direction of the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) to own, directly or indirectly, more than fifty percent (50%) of the outstanding voting securities or other ownership interests of such Person. 

  Section I.3.“Agreement” has the meaning set forth in the Preamble.

  Section I.4.“Alliance Manager” has the meaning set forth in Section 7.6(a). 

  Section I.5.“Anti-Corruption Laws” means laws, regulations, or orders prohibiting the provision of a financial or other advantage for a corrupt purpose or otherwise in connection with the improper performance of a relevant function, including without limitation, the US Foreign Corrupt Practices Act (FCPA), the Anti-Unfair Competition Law of the PRC and the Criminal Law of the PRC, and similar laws governing corruption and bribery, whether public, commercial or both, including industry codes dealing with government procurement, conflicts of interest, corruption or bribery, in each case to the extent applicable in the applicable country, region or territory. 

  Section I.6.“Auditor” has the meaning set forth in Section 8.7(a). 

  Section I.7.“Binding Orders” has the meaning set forth in Section 5.1(c).

  Section I.8.“BioNova” has the meaning set forth in the Preamble. 

  Section I.9.“BioNova Indemnified Party” has the meaning set forth in Section 12.1.

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  Section I.10.“BioNova Technology” means any and all Sole Inventions and interest in any Joint Inventions or Joint Patents that are Controlled by BioNova or any of its Affiliates or its or their Sublicensees at any time during the Term that are necessary or reasonably useful to Develop, Manufacture or Commercialize, or otherwise to research, make, have made, use, offer for sale, sell, have sold, and import the Licensed Compound or Licensed Products.

  Section I.11.“Biosimilar Product” means with respect to a particular Licensed Product sold by BioNova or any of its Affiliates or Sublicensees in a Region in the Territory, a product sold by a Third Party (other than a Sublicensee or any other Third Party in a chain of distribution originating from BioNova or any of its Affiliates or Sublicensees) in such Region in the Territory that (a) (i) [*], or (ii) [*], and (b) [*]. 

  Section I.12.“Breaching Party” has the meaning set forth in Section 14.3(a).

  Section I.13.“Business Day” means any day, other than a Saturday or a Sunday, on which the banks in each of Shanghai, Hong Kong, and New York are open for business.

  Section I.14.“Calendar Quarter” means each of the three month periods ending on March 31, June 30, September 30, and December 31 of any Calendar Year; provided, however: (a) the first Calendar Quarter of the Term will extend from the Effective Date to the end of the Calendar Quarter in which the Effective Date occurs; and (b) the last Calendar Quarter will extend from the beginning of the Calendar Quarter in which this Agreement expires or terminates until the effective date of such expiration or termination.

  Section I.15.“Calendar Year” means, for the first Calendar Year, the period beginning on the Effective Date and ending on December 31, 2021, and for each Calendar Year thereafter each twelve (12)-month period commencing on January 1, and ending on December 31, except that the last Calendar Year will commence on January 1 of the year in which this Agreement expires or terminates and end on the effective date of such expiration or termination.

  Section I.16.“Change of Control” means, with respect to a Person, (a) a merger, reorganization or consolidation of such Person with a third party that results in the voting securities of such Person outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a third party, together with its Affiliates, becomes the direct or indirect beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Person, or (c) the sale or other transfer to a third party of all or substantially all of such Person’s assets. Notwithstanding the foregoing, any transaction or series of transactions effected for the primary purpose of financing the operations of the applicable Person (including the issuance or sale of securities for financing purposes) or changing the form or jurisdiction of organization of such Person will not be deemed a “Change of Control” for purposes of this Agreement.

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  Section I.17.“Clinical Study” means a study in which human subjects or patients are dosed with a drug, whether approved or investigational.

  Section I.18.“Clinical Supply” has the meaning set forth in Section 5.1.

  Section I.19.“Clinical Transfer Price” has the meaning set forth in Section 5.1.

  Section I.20.“CMC” means the information referred to as “Chemistry, Manufacturing and Controls” information pertaining to a Licensed Product as may be required by a Regulatory Authority to be included or referenced in any IND for a candidate Licensed Product or in any application for Marketing Authorization with respect to such Licensed Product, provided it is understood that any information relating to Expression Technology shall be provided through the Disclosure Process.

  Section I.21.“CMC Data” means any data included in the CMC portion of a Regulatory Filing or in any supporting development reports thereto, in each case, with respect to any Licensed Product in any country in the world, except that required access by any Regulatory Authority in any country or region in the Territory to any information relating to Expression Technology shall be provided through the Disclosure Process.

  Section I.22.“Code” means Title 11 of the U.S. Code.

  Section I.23.“Combination” means any Combination Product or Combination Therapy.

  Section I.24.“Combination Product” means a product that (a) [*]; or (b) [*].

  Section I.25.“Combination Therapy” means any therapy or treatment regimen that comprises, or is a combination of (a) a Licensed Product, and (b) [*], where (a) and (b) [*] 

  Section I.26.“Commercial Supply Agreement” has the meaning set forth in Section 5.2.

  Section I.27.“Commercialization”, “Commercializing” or “Commercialize” means any and all activities related to the pre-marketing, launching, marketing, promotion (including advertising and detailing), packaging and having packaged, labeling, bidding, tendering and listing, pricing and reimbursement, distribution, storage, handling, offering for sale, selling, having sold, importing and exporting for sale, having imported and exported for sale, distribution, having distributed, customer service and support, and post-marketing safety surveillance and reporting of a product (including the Licensed Product), but not including Development or Manufacturing.

  Section I.28.“Commercially Reasonable Efforts” means, in respect of a Party’s obligation under this Agreement, the level of efforts and resources (measured as of the time that such efforts and resources are required to be used under this Agreement) that are commonly used by a company in the biopharmaceutical industry of a similar size and profile as such Party to Develop, Manufacture or Commercialize, as the case may be, a product owned by such company or to which it has rights, which product is at a similar stage in its development or product life and is of a similar market and profitability potential to the Licensed Product and taking into account all materially relevant factors, including the intellectual property protection of the product, product labeling or anticipated labeling, market potential, 

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  financial return, medical and clinical considerations, regulatory environments and competitive market conditions, market exclusivity, and other technical legal, scientific, medical or commercial factors that such a company would reasonably deem to be relevant.

  Section I.29.“Competitive Product” means [*]

  Section I.30.“Confidential Information” means (a) all trade secrets or confidential or proprietary information (including any tangible materials embodying any of the foregoing) of the disclosing Party or its Affiliates provided or disclosed to the other Party or any of its Affiliates in connection with this Agreement or disclosed in connection with the Confidentiality Agreement, and (b) the terms and conditions of this Agreement, which are the Confidential Information of each Party; provided, however, that Confidential Information will not include information that:

  (i)	is published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no breach of this Agreement on the part of the receiving Party;

  (ii)	is in the receiving Party’s possession prior to disclosure by the disclosing Party hereunder, and not through a prior disclosure by the disclosing Party, without any obligation of confidentiality with respect to such information (as evidenced by the receiving Party’s or such Affiliate’s written records or other competent evidence);

  (iii)	is subsequently received by the receiving Party from a Third Party who is not known by the receiving Party to be under an obligation of confidentiality to the disclosing Party under any agreement between such Third Party and the disclosing Party; or

  (iv)	is independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party’s Confidential Information (as evidenced by the receiving Party’s or such Affiliate’s written records or other competent evidence);

  provided, further, that clauses (ii) through (iv) above will not apply to the terms and conditions of this Agreement.

  Section I.31.“Confidentiality Agreement” means that certain mutual nondisclosure agreement by and between BioNova and Sutro, effective as of February 11, 2021.

  Section I.32.“Contract Manufacturing Organization” or “CMO” means any Third Party contract manufacturing organization.

  Section I.33.“Contract Research Organization” or “CRO” means any Third Party contract research organization.

  Section I.34.“Contract Sales Organization” or “CSO” means any Third Party contract sales organization.

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  Section I.35.“Control” or “Controlled” means, with respect to any Know-How, Patent Right, Regulatory Filing, Regulatory Approval or other property right, the legal authority or right (whether by ownership, license (other than a license granted pursuant to this Agreement) or otherwise) of a Party or its Affiliate, to grant access, a license or a sublicense of or under such Know-How, Patent Right, Regulatory Filing, Regulatory Approval or other property right, without breaching the terms of any agreement with a Third Party.

  Section I.36.“Cover,” “Covering” or “Covered” means, when referring to the Licensed Product: (a) with respect to an issued Patent Right, that, in the absence of a license granted to a Person under an issued claim included in such Patent Right, the manufacture, use, sale, offer for sale or import by such Person, or the conduct of any other specified activity by such Person, with respect to such Licensed Product would infringe such claim, or (b) with respect to an application for Patent Rights, that, in the absence of a license granted to a Person under a claim included in such application, the manufacture, use, sale, offer for sale or import by such Person, or the conduct of any other specified activity by such Person, with respect to such Licensed Product would infringe such claim if such patent application were to issue as a patent. 

  Section I.37.“Defect” has the meaning set forth in Section 5.1(g).

  Section I.38.“Development,” “Developing” or “Develop” means non-clinical, pre-clinical and clinical drug research and development activities, whether before or after Regulatory Approval, including drug metabolism and pharmacokinetics, translational research, toxicology, pharmacology, test method development and stability testing, process and packaging development and improvement, process validation, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, conduct of Clinical Studies, regulatory affairs, the preparation and submission of Regulatory Filings, performance of Clinical Study regulatory activities, and any other activities directed towards obtaining or maintaining Regulatory Approval of any Licensed Product. Development includes use and importation of the relevant compound (including the Licensed Compound) or product (including the Licensed Product) to conduct such Development activities. Development will not include Commercialization activities or Manufacturing.

  Section I.39.“Development Milestone Event” has the meaning set forth in Section 8.2. 

  Section I.40.“Development Milestone Payment” has the meaning set forth in Section 8.2.

  Section I.41.“Development Plans” has the meaning set forth in Section 4.2.

  Section I.42.“Disclosure Process” means, with respect to the disclosure of any information relating to Expression Technology, provision of such information (a) via a right of reference to a drug master file (or DMF) (or its equivalent in the applicable country or region in the Territory) filed by Sutro in the applicable country or region in the Territory or (b) directly to a Regulatory Authority by Sutro or a Third Party CRO mutually agreed by the Parties, in each case without disclosure to, or access by, BioNova or any of its Affiliates of any such information.

  Section I.43.“Dollars” or “US$” means United States dollars.

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  Section I.44.“Effective Date” has the meaning set forth in the Preamble. 

  Section I.45.“Expression Technology” means [*]

  Section I.46.“FDA” means the United States Food and Drug Administration or any successor agency thereto.

  Section I.47.“Field” means [*] 

  Section I.48.“First Commercial Sale” means with respect to the Licensed Product in any Region in the Territory, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such Region after the Marketing Authorization for such Licensed Product has been obtained in such Region.

  Section I.49.“Force Majeure Event” has the meaning set forth in Section 16.9.

  Section I.50.“Fully Burdened Manufacturing Cost” means the cost of Manufacturing the Licensed Product. Fully Burdened Manufacturing Costs will be a “standard cost” per unit (calculated annually), comprised of the following elements calculated in accordance with the applicable Accounting Standards, as consistently applied across Sutro’s or BioNova’s organization (as applicable) and with respect to Sutro’s or BioNova’s other products (as applicable): (a) [*] (b) [*], (c) [*] (d) [*], (e) [*] (f) [*] and (g) [*]. To the extent that Licensed Products are sourced by Sutro from one or more CMOs engaged by Sutro, Sutro’s Fully Burdened Manufacturing Costs will be [*], and to the extent any Licensed Products are sourced by a Selling Party from another Person, such Selling Party’s Fully Burdened Manufacturing Costs of such Licensed Products will be [*]. For clarity, [*]

  Section I.51.“GCP” or “Good Clinical Practice” means all applicable then-current standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Studies, including, as applicable, (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products, (b) the Declaration of Helsinki (2013) as last amended at the 64th World Medical Association in October 2013 and any further amendments or clarifications thereto, (c) as set forth in the PRC Good Clinical Practice for Pharmaceuticals effective as of July 1, 2020 and its subsequent amendments, (d) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), and (e) the equivalent applicable Laws in any relevant Region, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects. 

  Section I.52.“Global Development Plan” has the meaning set forth in Section 4.2.

  Section I.53.“GLP” or “Good Laboratory Practice” means all applicable then-current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58, the PRC Good Laboratory Practice effective as of September 1, 2017, or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and 

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  Development (OECD), and such standards of good laboratory practice as are required by the equivalent applicable Laws in the relevant Region and other organizations and governmental agencies in countries in which the Licensed Product is intended to be sold by the Party that is subject to such standards. 

  Section I.54.“GMP” or “Good Manufacturing Practice” means all applicable then-current standards for Manufacturing, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. §§ 201, 211, 600 and 610 and all applicable FDA guidelines and requirements, (b) European Directive 2003/94/EC for medicines and investigational medicines for human use and the applicable guidelines stated in the Eudralex guidelines, (c) Pharmaceutical Good Manufacturing Practice of the PRC effective as of March 1, 2011 and its appendices, and all relevant NMPA guidelines and regulations, (d) the principles detailed in the applicable ICH guidelines, (e) the conduct of an inspection by a Qualified Person (as defined therein) and the execution by such Qualified Person of an appropriate certification of inspection and (f) the equivalent applicable Laws in any relevant Region, each as may be amended and applicable from time to time. For clarity, applicable GMP will include the GMP in the Region where Licensed Products are intended to be used or sold. 

  Section I.55.“Governmental Authority” means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal, official or officer, exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government.

  Section I.56.“Gross Profit” means, for specific units of Licensed Product sold during a particular time period, (a) the Net Sales arising from such Licensed Product sales minus (b) the Selling Party’s Fully Burdened Manufacturing Costs and Other Costs of such Licensed Product, in all instances solely to the extent actually paid or incurred by BioNova, its Affiliate, or its Sublicensee (as appropriate) and not otherwise reimbursed or deducted more than once (i.e. not ‘double counted’).

  Section I.57.“ICH” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

  Section I.58.“IND” means any (a) Investigational New Drug application filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, or (b) any comparable filings outside the U.S. required to commence human clinical trials in such country or Region (such as an application for clinical trial authorization or clinical trial approval in the Territory), and all supplements or amendments that may be filed with respect to the foregoing.

  Section I.59.“IND-Enabling Studies” means the non-clinical pharmacokinetic and toxicology studies required to meet the requirements for filing an IND.

  Section I.60.“Indemnified Party” means a Person entitled to indemnification under ARTICLE XII.

  Section I.61.“Indemnifying Party” means a Party from whom indemnification is sought under ARTICLE XII.

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  Section I.62.“Indication” means, with respect to a particular compound or product, the use of such compound or product for treatment of: (a) [*]; or (b) [*]. For clarity, (i) [*]; (ii) [*]; and (iii) [*]

  Section I.63.“Initial Clinical Supply” has the meaning set forth in Section 5.1(a).

  Section I.64.“Infringement” has the meaning set forth in Section 9.3(a).

  Section I.65.“Infringement Action” has the meaning set forth in Section 9.3(b).

  Section I.66.“Infringement Claim” has the meaning set forth in Section 9.4.

  Section I.67.“Invention” means any process, method, composition of matter, article of manufacture, discovery or finding, patentable or otherwise, that is invented as a result of a Party (or the Parties jointly) exercising its (their) rights or carrying out its obligations under this Agreement, including all rights, title and interest in and to the intellectual property rights therein.

  Section I.68.“Joint Global Study” has the meaning set forth in Section 4.5.

  Section I.69.“Joint Patents” has the meaning set forth in Section 9.1(b).

  Section I.70.“Joint Inventions” has the meaning set forth in Section 9.1(b).

  Section I.71.“JSC” has the meaning set forth in Section 7.1.

  Section I.72.“Know-How” means all proprietary chemical and biological materials and other tangible materials, inventions, practices, methods, protocols, formulae, knowledge, know-how, trade secrets, processes, procedures, assays, skills, experience, techniques, information (including scientific, technical or regulatory information), data, documentation, processes, methods, techniques, materials, technology, results, analyses, laboratory, pre-clinical, clinical, and other data, clinical dossiers, or other know-how, including pharmacology, toxicology, drug stability, manufacturing and formulation methodologies and techniques, clinical and non-clinical safety and efficacy studies, marketing studies, absorption, distribution, metabolism and excretion studies, whether patentable or otherwise. 

  Section I.73.“Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, decrees, judgments or ordinances of any Governmental Authority, or any license, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.

  Section I.74.“Licensed Compound” means (a) STRO-001, an ADC the chemical structure of which is described in Exhibit A, (b) [*], and (c) [*]

  Section I.75.“Licensed Know-How” means any and all Know-How that is Controlled by Sutro or any of its Affiliates as of the Effective Date or at any time during the Term (including any Regulatory Filings, all information and data contained in Regulatory Filings, CMC Data, and interest in any Joint Inventions) that is necessary or reasonably useful to Develop, Manufacture, Commercialize, or otherwise to research, make, have made, use, offer for sale, sell, have sold, and import the Licensed Compound or Licensed Products; provided that with respect to all Licensed Know-How comprising Expression 

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  Technology that is not publicly available, access provided by Sutro to BioNova thereto shall be limited to the Disclosure Process. For the avoidance of doubt, Licensed Know-How includes the dossier of the Licensed Products and all documents and materials. 

  Section I.76.“Licensed Mark(s)” means any Trademark(s) that Sutro or its Affiliates registers with a Governmental Authority in any Region in the Territory is used or intended to be used in connection with the Commercialization of a Licensed Product. Licensed Marks as of the Effective Date are set forth in Exhibit B.

  Section I.77.“License Option” has the meaning set forth in Section 2.1.

  Section I.78.“License Option Payment” has the meaning set forth in Section 2.2.

  Section I.79.“License Option Exercise Notice” has the meaning set forth in Section 2.5.

  Section I.80.“License Option Exercise Payment” has the meaning set forth in Section 8.1.

  Section I.81.“License Option Exercise Period” has the meaning set forth in Section 2.5.

  Section I.82.“Licensed Patents” means any and all Patent Rights that are Controlled by Sutro or any of its Affiliates as of the Effective Date or at any time during the Term (including any interest in any Joint Patents) that (a) are set forth in Exhibit C, (b) are necessary or reasonably useful to Develop, Manufacture, Commercialize, or otherwise to research, make, have made, use, offer for sale, sell, have sold, and import the Licensed Compound or Licensed Products, or (c) Cover any Licensed Know-How; provided that with respect to all Licensed Patents comprising Expression Technology that is not publicly available, access provided by Sutro to BioNova thereto shall be limited to the Disclosure Process. Licensed Patents as of the Effective Date are set forth in Exhibit C. 

  Section I.83.“Licensed Product” means any product containing a Licensed Compound (whether alone as the sole Active Ingredient or as a monotherapy or as part of a Combination), in any form, presentation, formulation or dosage form.

  Section I.84.“Licensed Technology” means collectively Licensed Patents and Licensed Know-How. 

  Section I.85.“Losses” means damages, losses, liabilities, costs (including costs of investigation, defense), fines, penalties, taxes, expenses, or amounts paid in settlement (in each case, including reasonable attorneys’ and experts’ fees and expenses), in each case resulting from an Action.

  Section I.86.“Manufacture,” “Manufactured” or “Manufacturing” means all activities related to the manufacture or production of the Licensed Compound or Licensed Product, including the production of any of the following to the extent used in the Licensed Product: any drug substance produced in bulk form for use as an Active Ingredient, drug product, compounded or finished final packaged and labeled form, and in intermediate states, including the following activities: reference standard preparation, purification, formulation, scale-up, packaging, quality assurance oversight, quality control testing (including in-process release and stability testing), validation activities directly related to all of the 

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  foregoing, and data management and recordkeeping related to all of the foregoing. References to a Person engaging in Manufacturing activities will include having any or all of the foregoing activities performed by a Third Party.

  Section I.87.“Manufacturing License” has the meaning set forth in Section 5.6.

  Section I.88.“Manufacturing Requirements” has the meaning set forth in Section 5.1(e).

  Section I.89.“Marketing Authorization” means the grant of all necessary final or conditional permits, registrations, authorizations, licenses and approvals (or waivers) required for the Commercialization of the Licensed Product for use in the Field and in the Territory, including any Regulatory Approval for sale or marketing, and, where required, Pricing and Reimbursement Approvals. 

  Section I.90.“NDA” means a new drug application or similar application or submission filed with or submitted to any Regulatory Authority to obtain permission to commence marketing and sales of a pharmaceutical product in any particular jurisdiction.

  Section I.91.“Net Sales” means all amounts invoiced on sales by BioNova or any of its Affiliates or its or their Sublicensees (for the purpose of this definition, “Sublicensees” will not include any distributors or wholesalers) (the “Selling Party”) for any Licensed Product sold to Third Parties other than Sublicensees less the following deductions in each case solely to the extent reasonable, customary, allocable and actually taken or applied:

  (a)	discounts (including trade, cash and quantity discounts), cash and non-cash coupons, charge back payments and rebates granted to managed health care organizations, hospitals, pharmacies, or group purchasing organizations, or to federal, state and local governments, their agencies, and purchasers and reimbursors or to customers or required by applicable Law (including governmental medical assistance programs);

  (b)	credits, allowances, repayments, discounts to and chargebacks for claims, spoiled, damaged, or outdated goods, rejections or returns of the Licensed Products, including Licensed Products returned in connection with recalls or withdrawals;

  (c)	any sales, value added or similar taxes, insurance, custom duties, excise or other similar governmental charges levied directly on the production, sale, transportation, delivery or use of a Licensed Product that are paid by or on behalf of the Selling Party, but not including any tax levied with respect to income;

  (d)	actual freight and insurance costs and other expenses incurred in distributing, warehousing, importing, handling and transporting the Licensed Product to distributors or customers;

  (e)	wholesaler’s stocking, inventory management or distribution fees; and

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  (f)	amounts that are written off as uncollectible; provided that if any such written-off amounts are subsequently collected, such collected amounts will be included in Net Sales in the Calendar Quarter in which they are subsequently collected.

  In the event that a Licensed Product is sold as a Combination, Net Sales, for the purposes of determining royalty payments on the Combination, will mean the gross amount collected for the Combination less the deductions set forth in clauses (a) - (f) above, multiplied by a proration factor that is determined as follows:

  (i) If all active pharmaceutical components of the Combination were sold separately, the proration factor will be determined by the formula [*]; 

  (ii) If the Licensed Product components containing only the Licensed Compound as their Active Ingredient are sold separately from the other component(s), but the other Active Ingredient components in such Combination are not sold separately, then the proration factor will be determined by the formula [*]; 

  (iii) If the Licensed Product components containing only the Licensed Compound as their Active Ingredient are not sold separately from the other component(s), but the other Active Ingredient components in such Combination are sold separately, then the proration factor will be determined by the formula [*] or

  (iv) If all Active Ingredient(s) of the Combination were not sold or provided separately, the proration factor will be determined by the Parties in good faith negotiations based on the relative value contributed by each component.

  With respect to the calculation of Net Sales:

  (A)	Net Sales only include the value charged or invoiced on the first arm’s length sale to a Third Party. The transfer of a Licensed Product to an Affiliate, Sublicensee, or other Third Party (w) in connection with the Development or testing of a Licensed Product (including the conduct of Clinical Studies), (x) for purposes of distribution as promotional samples, (y) for indigent or similar public support or compassionate use programs, or (z) by and between BioNova and its Affiliates or its or their Sublicensees will not, in any case, be considered a Net Sale of a Licensed Product under this Agreement;

  (B)	Net Sales (including deductions taken in accordance with subsections (a)-(f) above) shall be determined in accordance with the Accounting Standards or in the case of Sublicensees, such similar accounting principles, consistently applied; and 

  (C)	Notwithstanding anything to the contrary in this Agreement, in no event (after accounting for deductions taken in accordance with subsections (a)-(f) above) shall Net Sales for a Licensed Product be lower than ‘net sales’ of such Licensed Product as reported in BioNova’s (or the applicable Affiliate’s or Sublicensee’s) publicly available financial statements or reports.

  Section I.92.“NMPA” means the National Medical Products Administration of the PRC (formerly known as the China Food and Drug Administration), or its successor.

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  Section I.93.“Non-Breaching Party” has the meaning set forth in Section 14.3(a).

  Section I.94.“Non-Conforming Product” has the meaning set forth in Section 5.1(g).

  Section I.95.“Other Costs” means freight, import/export fees, taxes, and other charges associated with the supply or acquisition of a given order or quantity of Licensed Product calculated in accordance with the applicable Accounting Standards, as consistently applied across Sutro’s or BioNova’s organization (as applicable) and with respect to Sutro’s or BioNova’s other products (as applicable), and which charges are not included or otherwise accounted for in the costs, expenses and other charges tabulated in determining the Fully Burdened Manufacturing Cost for the same given order or quantity of Licensed Product.

  Section I.96.“Part 2 – STRO-001-BCM1 Phase 1 Study” means the Part 2 dose expansion of the STRO-001-BCM1 Phase 1 Study, as illustrated in the study design described in Exhibit D.

  Section I.97.“Party” means either Sutro or BioNova; “Parties” means Sutro and BioNova, collectively.

  Section I.98.“Patent Challenge” has the meaning set forth in Section 14.3(d).

  Section I.99.“Patent Rights” means the rights and interests in and to (a) all patents and patent applications (including provisional applications), including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, re-issues, additions, renewals, extensions, confirmations, registrations, any other pre- or post-grant forms of any of the foregoing, (b) any confirmation patent or registration patent or patent of addition, utility models, patent term extensions, and supplemental protection certificates or requests for continued examinations, foreign counterparts, and the like of any of the foregoing, and (c) any and all patents that have issued or in the future issue from the foregoing patent applications, including author certificates, utility models, petty patents, innovation patents and design patents and certificates of invention.

  Section I.100.“Periodic Updates” has the meaning set forth in Section 2.3.

  Section I.101.“Person” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization or a Governmental Authority.

  Section I.102.“Pharmacovigilance Agreement” has the meaning set forth in Section 4.10.

  Section I.103.“Phase 1 Study” means a Clinical Study of an investigational product in subjects with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. 312.21(a), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in the Territory.

  Section I.104.“Phase 1/2 Study” means a Clinical Study of the Licensed Product conducted by or on behalf of BioNova or its Affiliates in the Territory, as illustrated in the study design and development plan described in Exhibit E.

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  Section I.105.“Phase 2 Study” means a Clinical Study of an investigational product in subjects with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, pharmacokinetics, pharmacodynamics, and dose finding information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in the Territory.

  Section I.106.“Phase 3 Study” means a Clinical Study of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Study prescribed by the relevant Regulatory Authority in the Territory.

  Section I.107.“Pivotal Study” means any (a) Phase 3 Study, or (b) other Clinical Study (or any arm thereof) in humans of a pharmaceutical or biologic product, the results of which, together with prior data and information concerning such product, are intended to be or otherwise are sufficient, without any additional clinical trial to meet the evidentiary standard for demonstrating the safety, purity, efficacy, and potency of such active substance of such product established by a Regulatory Authority in any particular jurisdiction and that is intended to support, or otherwise supports, the filing of an Marketing Authorization application in such jurisdiction (including any bridging study).

  Section I.108.“PRC” means the People’s Republic of China, [*].

  Section I.109.“Pricing and Reimbursement Approval” means, with respect to the Licensed Product, the governmental approval, agreement, determination or decision establishing the price or level of reimbursement for such Licensed Product in a given Region in the Territory in such jurisdiction in the Field in the Territory. 

  Section I.110.“Purchase Order” has the meaning set forth in Section 5.1(c).

  Section I.111.“Quality Agreement” has the meaning set forth in Section 5.1(j).

  Section I.7.“Region” means each of the PRC, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan.

  Section I.8.“Regulatory Approval” means the final or conditional approval of the applicable Regulatory Authority necessary for the marketing and sale of a Licensed Product in the Field in a country(ies) or Region(s), excluding separate Pricing and Reimbursement Approval that may be required.

  Section I.9. “Regulatory Approval Application” means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  Section I.10. “Regulatory Authority” means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other Governmental Authority with authority over the clinical development, Manufacture, marketing or sale of the Licensed Product in a Region, 

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  including the National Medical Products Administration (formerly the China Food and Drug Administration) in the PRC.

  Section I.11.“Regulatory Data Exclusivity” means with respect to a Licensed Product in a Region, the period of time during which (a) a Party or its Affiliate or Sublicensee has been granted the exclusive legal right by a Regulatory Authority in such Region to market and sell the Licensed Product; and (b) the data and information submitted by a Party or its Affiliate or Sublicensee to the relevant Regulatory Authority in such Region for purposes of obtaining Regulatory Approval may not be disclosed, referenced, or relied upon in any way by a Third Party or such Regulatory Authority (including by relying upon the Regulatory Authority’s previous findings regarding the safety or effectiveness of the Licensed Product) to support the Regulatory Approval of any product by a Third Party in such Region. 

  Section I.12.“Regulatory Filing” means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the Licensed Product, including any documents submitted to any Regulatory Authority, including INDs, Regulatory Approval Applications and all correspondence with any Regulatory Authority with respect to any Licensed Product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

  Section I.13.“Regulatory Standards” means all laws, ordinances, rules and regulations applicable to the Manufacturing of Licensed Product or any aspect thereof, including (a) all applicable Laws; (b) GMP, and (c) the applicable rules and regulations promulgated under or by the NMPA or any other applicable Regulatory Authority, in each of the above cases, as may be amended from time to time.

  Section I.14.“Required Manufacturing Changes” has the meaning set forth in Section 5.1(f).

  Section I.15.“Royalty Term” has the meaning set forth in Section 8.4(b).

  Section I.16.“Safety Data” means any Adverse Event information from Clinical Studies and all results from non-clinical safety studies, including toxicology and carcinogenicity data (if any), with respect to the Licensed Product required by one or more Regulatory Authorities to be collected or to be reported to such Regulatory Authorities under applicable Laws, but excluding any information related to the efficacy of the Licensed Product. 

  Section I.17.“Sales Milestone Event” has the meaning set forth in Section 8.3.

  Section I.18.“Sales Milestone Payment” has the meaning set forth in Section 8.3.

  Section I.19.“Sell-Off Period” has the meaning set forth in Section 14.4(f)(i).

  Section I.20.“Senior Officers” means, (a) with respect to BioNova, [*] and (b) with respect to Sutro, [*]. If the position of any of the Senior Officers identified in this definition no longer exists due to a corporate reorganization, corporate restructuring or the like that results in the elimination of the identified position, the applicable title of the Senior Officer set forth herein will be replaced with the title of another executive officer with responsibilities and seniority comparable to the eliminated Senior Officer, and the relevant Party will promptly provide notice of such replacement title to the other Party.

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  Section I.21.“SIAC” has the meaning set forth in Section 15.2.

  Section I.22.“SIAC Rules” has the meaning set forth in Section 15.2.

  Section I.23.“Specifications” means the specifications for the Licensed Product set forth in the Quality Agreement.

  Section I.24.“Sole Inventions” has the meaning set forth in Section 9.1(b).

  Section I.25.“STRO-001-BCM1 Phase 1 Study” means the STRO-001-BCM1 Phase 1 Study (ClinicalTrials.gov Identifier: NCT03424603) being conducted by Sutro in the US, as illustrated in the study design set forth in Exhibit D.

  Section I.26.“Subcontract” has the meaning set forth in Section 3.2(b).

  Section I.27.“Subcontractor” has the meaning set forth in Section 3.2(b).

  Section I.112.“Sublicense” means a grant of rights from BioNova to a Sublicensee under any of the rights licensed to BioNova by Sutro under Section 3.1 and Section 3.4.

  Section I.113.“Sublicensee” means, with respect to a Party, a Third Party sublicensee of rights granted to such Party under this Agreement or a Third Party licensee of rights with respect to the Licensed Product, which rights are retained by such Party under this Agreement with respect to such Licensed Product, or any further sublicensee of such rights (regardless of the number of tiers, layers or levels of sublicenses of such rights). 

  Section I.114.“Sutro” has the meaning set forth in the Preamble. 

  Section I.115.“Sutro Indemnified Party” has the meaning set forth in Section 12.2. 

  Section I.116.“Tax Withholdings” has the meaning set forth in Section 8.8.

  Section I.117.“Term” has the meaning set forth in Section 14.1.

  Section I.118.“Territory” means one or more or all of the following Regions: PRC, Macau, Hong Kong, and Taiwan, in each case as the context may require. 

  Section I.119.“Territory-Specific Development Plan” has the meaning set forth in Section 4.2.

  Section I.120.“Third Party” means any Person other than a Party or any of its Affiliates.

  Section I.121.“Third Party Blocking IP” has the meaning set forth in Section 8.6(a).

  Section I.122.“Third Party Claim” has the meaning set forth in Section 12.3(a).

  Section I.123.“Third Party Losses” means Losses resulting from an Action by a Third Party.

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  Section I.124.“Trademark” means all registered and unregistered trademarks, service marks, trade dress, trade names, logos, insignias, domain names, symbols, designs, and combinations thereof.

  Section I.125.“United States” or “U.S.” or “US” means the United States and its territories, possessions and commonwealths.

  Section I.126.“Upstream Licenses” means any and all agreements between Sutro or any of its Affiliates, on the one hand, and any Third Party, on the other hand, pursuant to which Sutro has (a) in-licensed any Patent Rights or Know-How owned or Controlled by such Third Party that are included as part of the Licensed Patents or Licensed Know-How or (b) agreed to provisions that would require BioNova to make any payments (including royalties) to any Third Party or to undertake or observe any restrictions or obligations with respect to the Development or Commercialization of Licensed Products in the Field in the Territory. 

  Section I.127.“Upstream Licensor” means a Third Party that is party to an Upstream License.

  Section I.128.“Valid Claim” means either: (a) a claim Covering the composition of matter or the method of use of the Licensed Compound or Licensed Product included within an issued and unexpired patent included in the Licensed Patents that (i) has not been irrevocably or unappealably disclaimed or abandoned, or been irrevocably or unappealably held unenforceable, unpatentable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction; and (ii) has not been admitted to be invalid or unenforceable through reissue, disclaimer, or otherwise, or (b) a claim Covering the composition of matter of the Licensed Compound or Licensed Product [*] included within the Licensed Patents, in each case, that has neither been irretrievably cancelled, withdrawn or abandoned without the possibility of appeal or refiling; provided, however, that Valid Claim will exclude any such pending claim in a patent application that has not been granted within [*] years following the earliest priority filing date for such application.

  ARTICLE II
LICENSE OPTION

  Section I.28.Grant of License Option. Sutro hereby grants to BioNova or its designated Affiliate an exclusive option as described in this ARTICLE II to obtain the license grant set forth in Section 3.1 below and other related rights under this Agreement (the “License Option”).

  Section I.29.License Option Payment. In consideration of the License Option granted by Sutro to BioNova hereunder, within [*] immediately following the Effective Date and BioNova’s receipt of an invoice from Sutro, BioNova will pay to Sutro Four Million Dollars (US$4,000,000) (the “License Option Payment”). The License Option Payment will be non-creditable and non-refundable [*]

  Section I.30.Periodic Updates. On a periodic basis and on an ad-hoc basis, as frequently as the Parties reasonably determine would be helpful in BioNova’s decision regarding the License Option, but in any event no less frequently than [*], Sutro will disclose and provide updates to BioNova of the available clinical data from the STRO-001 BCM1 Phase 1 Study (the “Periodic Updates”) and the Parties will discuss in good faith such updates and the progress of the STRO-001 BCM1 Phase 1 Study. 

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  Section I.31.Phase 1/2 Study.

  (A)Responsibility. BioNova will use Commercially Reasonable Efforts to conduct the Phase 1/2 Study in the PRC.

  (B)Phase 1/2 Study Milestone. BioNova (directly, or through its Affiliates, or its or their contractors) will use Commercially Reasonable Efforts to [*]; provided (i) [*] (ii) [*] and (iii) [*]

  (C)License. Subject to the terms and conditions of this Agreement, Sutro hereby grants to BioNova and its Affiliates an exclusive (even with respect to Sutro and its Affiliates), sublicensable (to Affiliates only, subject to Section 3.2(a)), non-transferable (except as provided in Section 16.1), royalty-free license under the Licensed Technology to Develop and otherwise use, distribute, and import the Licensed Products in the Field in the Territory solely to conduct the Phase 1/2 Study in the Territory.

  (D)Right of Reference. Sutro, on behalf of itself and its Affiliates and its and their Sublicensees, hereby grants to BioNova and its Affiliates, a right of reference to use, and will provide BioNova and its Affiliates with access to, any and all Regulatory Filings and Regulatory Approvals (including all data therein) owned or otherwise Controlled by Sutro, its Affiliates, and its and their Sublicensees that are necessary or reasonably useful to conduct the Phase 1/2 Study in the Territory, provided however that BioNova’s access to any Expression Technology will be provided through the Disclosure Process, with which BioNova will provide its assistance upon Sutro’s request.

  (E)Subcontracting. Section 3.2 and Section 3.3 will apply to BioNova’s engagement of Subcontractors in connection with the conduct of the Phase 1/2 Study.

  (F)Transfer of Licensed Know-How. Within [*] and as promptly as reasonably practicable after the Effective Date, Sutro will disclose and make available to BioNova the Licensed Know-How and Regulatory Filings Controlled by Sutro or its Affiliates that exist as of the Effective Date and are reasonably necessary for BioNova to prepare the Regulatory Filings required by the NMPA and conduct the Phase 1/2 Study in the Territory. Sutro may make such Licensed Know-How and Regulatory Filings available in such reasonable form as is maintained by Sutro or its Affiliates or Sublicensees and reasonably acceptable for use in certain Development activities in the Territory as contemplated by this Section 2.4. Sutro will provide BioNova with reasonable access to Sutro’s or its Affiliates’ personnel involved in the Development or Manufacture of such Licensed Compound and Licensed Product, either in-person at Sutro’s or its Affiliates’ facilities or by teleconference, at no cost and expense to BioNova, as reasonably necessary for use of such Licensed Know-How and Regulatory Filings as contemplated under this Section 2.4. BioNova acknowledges and agrees that any Know-How relating to the Manufacture of the Licensed Product beyond what is reasonably required for the Regulatory Filings (portions of which relate to the Expression Technology will be provided through the Disclosure Process), will be provided only after BioNova has exercised the License Option and only pursuant to the terms and conditions of the Commercial Supply Agreement.

  (G)Clinical Supply. Section 5.1 will apply to the Clinical Supply of the Licensed Product by Sutro to BioNova for the conduct of the Phase 1/2 Study. Except in the event BioNova exercises the License Option, BioNova will not use such Clinical Supply for any other purpose.

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  Section I.32.Exercise of License Option. BioNova or its designated Affiliate will have the right to exercise or not exercise, for any or no reason in its sole discretion, the License Option. BioNova or its designated Affiliate may exercise the License Option by (a) providing to Sutro written notice of its exercise of the License Option (such notice, the “License Option Exercise Notice”) at any time during the period commencing on the Effective Date until the earlier to occur of the following: (i) [*] following BioNova’s completion [*] in the dose expansion portion, and (ii) [*](such period, the “License Option Exercise Period”), and (b) paying in full to Sutro the License Option Exercise Payment pursuant to Section 8.1. In the event that BioNova or its designated Affiliate has not provided Sutro with a License Option Exercise Notice and paid the License Option Exercise Payment prior to the expiration of the License Option Exercise Period, then the License Option and this Agreement will automatically expire without any further action of the Parties and Sutro will thereafter retain the exclusive right to Develop, Manufacture and Commercialize and otherwise make, have made, use, offer for sale, sell, have sold, and import the Licensed Compounds and Licensed Products, in all fields including in and outside of the Field, and throughout the world including in and outside of the Territory, whether on its own or in collaboration with a Third Party, and Sutro will have no further obligation or liability to BioNova whatsoever in respect of the License Option or otherwise under this Agreement.

  Section I.33.Effect of License Option Exercise. Except for this ARTICLE II, ARTICLE VIII (solely with respect to the License Option Payment), ARTICLE X, ARTICLE XI, ARTICLE XIII, ARTICLE XV, ARTICLE XVI, Section 3.8, Section 5.1 (as necessary to effectuate Section 2.4(g)), Section 5.3 (as necessary to effectuate Section 2.4(g)), Section 5.4 (as necessary to effectuate Section 2.4(g)), Section 14.3(b)(i), and the provisions of ARTICLE I and the other provisions of this Agreement necessary to give effect to such provisions, which will be effective as of the Effective Date and will continue in full force until the earlier of BioNova’s exercise of the License Option (in which case, Section 14.1 will apply to all the provisions of this Agreement) or the expiration of the License Option, the provisions of this Agreement will not be effective unless and until BioNova exercises the License Option in accordance with the terms and conditions of this ARTICLE II. In the event, during the License Option Exercise Period, BioNova or its designated Affiliate provides to Sutro the License Option Exercise Notice stating that BioNova wishes to exercise the License Option, (a) BioNova will pay Sutro the License Option Exercise Payment pursuant to Section 8.1 and (b) as of the date of such License Option Exercise Notice, the license grant set forth in Section 3.1 and the remaining provisions of this Agreement that are not then-currently in effect will be automatically effective without any further action of the Parties.

  Section I.34.Sutro Obligations in Support of Option. During the License Option Exercise Period, Sutro will not, and will cause its Affiliates not to, license, assign, transfer, sell, encumber or otherwise grant to any Third Party any rights under the Licensed Technology or to Develop or Commercialize the Licensed Compound or Licensed Product in any manner that would conflict with, restrict, or limit BioNova’s rights under the License Option, right to conduct the Phase 1/2 Study under this ARTICLE II, and the right to obtain the licenses and rights under Sutro’s rights in the Licensed Technology with respect to Licensed Compounds and Licensed Products as contemplated under the License Option as set forth in this ARTICLE II. As of the Effective Date, Sutro intends to [*] In the event (a) * or (b) [*]

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  ARTICLE III
LICENSE GRANTS

  Section I.35.License Grant to BioNova. Subject to the terms and conditions of this Agreement, Sutro hereby grants to BioNova and its Affiliates an exclusive (even with respect to Sutro and its Affiliates), sublicensable (subject to Section 3.2(a)), non-transferable (except as provided in Section 16.1), royalty-bearing license under the Licensed Technology to Develop (subject to this Section 3.1), Commercialize and otherwise use, offer for sale, sell, have sold, and import the Licensed Compounds and Licensed Products in the Field in the Territory. Notwithstanding the foregoing sentence, Sutro shall have the right to conduct Development in the Territory with respect to the Licensed Compounds and Licensed Products provided that during the Term, Sutro will first furnish to BioNova a written outline of its intended Development activities in the Territory and provide BioNova a reasonable opportunity to participate in such proposed activities. If no understanding is reached after a reasonable period of discussion with BioNova, Sutro will be entitled, notwithstanding the exclusive license grant above, to proceed with Development activities in the Territory if such Development activities would not, or would not reasonably be expected to, materially negatively impact BioNova’s Development or Commercialization of the Licensed Compounds and Licensed Products in the Field in the Territory, and in such event, Sutro will keep BioNova reasonably informed of the Development activities occurring in the Territory. The Parties agree the technology transfer and license agreement referenced in Section 5.5 will (a) [*], and (b) [*]

  Section I.36.Sublicensing and Subcontracting. 

  (A)BioNova Right to Sublicense. Subject to the terms and conditions of this Agreement, BioNova may grant Sublicenses of (i) any and all rights granted to BioNova by Sutro under this Agreement, including pursuant to Section 3.1 and Section 3.4, to its Affiliates (through multiple tiers) with prior notice to Sutro but without Sutro’s prior written approval or consent, (ii) any and all rights granted to BioNova by Sutro under this Agreement, including pursuant to Section 3.1 and Section 3.4, with respect to Hong Kong, Macau, and Taiwan, to any Third Party with prior notice to Sutro but without Sutro’s prior written approval or consent, and (iii) any and all rights granted to BioNova by Sutro under this Agreement, including pursuant to Section 3.1 and Section 3.4, with respect to the PRC, to any Third Party with Sutro’s prior written approval (not to be unreasonably withheld, delayed or conditioned). All such Sublicenses granted to BioNova’s Affiliates will be subject to any and all rights of Sutro under this Agreement and will subsist only for so long as such Sublicensee remains an Affiliate of BioNova. 

  (B)BioNova Right to Sublicense Subcontractors. Subject to the terms and conditions of this Agreement, BioNova may engage Third Party subcontractors engaged to provide contract research services (i.e. a CRO), contract manufacturing services (i.e. a CMO), or contract sales services (i.e. a CSO) in connection with this Agreement to Develop, Manufacture and/or Commercialize the Licensed Compound and Licensed Product (each, a “Subcontract”, and the Person so engaged, a “Subcontractor”), without prior notice to Sutro and without Sutro’s prior written approval or consent.

  (C)Sublicense and Subcontract Requirements. Each Sublicense and Subcontract shall be consistent with the terms and conditions of this Agreement and shall contain the following additional terms and conditions: 

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  (i)requiring each Sublicensee and Subcontractor to protect and keep confidential any Confidential Information of the Parties in accordance with ARTICLE X of this Agreement; 

  (ii)requiring each Sublicensee and Subcontractor to provide BioNova with Control of all Patent Rights and rights in Know-How and other intellectual property rights in any and all Inventions developed by such Sublicensee or Subcontractor so that BioNova is fully enabled to fulfill its obligations under Section 3.5 and Section 9.1; 

  (iii)restricting each Sublicensee from granting a further sublicense of any Licensed Technology (except as expressly provided in the case of sublicenses to BioNova’s Affiliates pursuant to Section 3.2(a)(i) or with Sutro’s prior written consent); and

  (iv)not imposing any obligation or liability upon Sutro.

  (D)BioNova Responsible and Liable. BioNova shall remain directly responsible and liable for all of its obligations under this Agreement that have been delegated or sublicensed to any Sublicensee or Subcontractor. Any conduct by a Sublicensee or Subcontractor that would have constituted a breach of this Agreement if such conduct had been by BioNova shall be imputed to BioNova and be deemed a breach of this Agreement. BioNova must not grant a Sublicense or Subcontract to any Third Party Sublicensee or Subcontractor who has been debarred or disqualified by a Regulatory Authority (as more fully detailed in Section 11.4).

  (E)Copies of Sublicense Agreements. Within [*] after the grant of each Sublicense that is not related to the engagement of a CRO, CMO, CSO, or other Subcontractor, BioNova shall provide to Sutro a copy of the Sublicense agreement, which agreement may be redacted with respect to sensitive financial terms, provided that the extent of such redactions are consistent with the United States Securities and Exchanges Commission’s requirements and guidelines governing redaction of information from material contracts.

  (F)Sublicense Survival. Upon the termination of this Agreement, at the written request of any Third Party Sublicensee of BioNova that is granted a Sublicense to Commercialize in the Territory or any Region thereof and which Sublicensee is not then in breach of its Sublicense agreement, Sutro agrees to consider in good faith entering into a direct license agreement with such Sublicensee under substantially the same terms and conditions of this Agreement (except for ARTICLE II), mutatis mutandis, such substitute Sublicense agreement, subject to agreement by Sutro and such Sublicensee, to be effective from and after the date of such written request so as to avoid a gap in the Sublicensee’s rights.

  Section I.37.Performance by Independent Contractors. BioNova may contract or delegate any portion of its obligations hereunder to a contractor (including a Subcontractor) subject to the terms and condition of the applicable provisions of Section 3.2 and Section 16.8.

  Section I.38.Right of Reference. Each Party, on behalf of itself and its Affiliates and its and their Sublicensees, hereby grants to the other Party, its Affiliates, and its and their Sublicensees, a right of reference to use, and will provide the other Party, its Affiliates, and its and their Sublicensees with access to, any and all Regulatory Filings and Regulatory Approvals (including all data therein) owned or 

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  otherwise Controlled by the first Party, its Affiliates, and its and their Sublicensees that are necessary or reasonably useful for the Development, Manufacture, Commercialization or other exploitation of the Licensed Compound or Licensed Products in the Field in the other Party’s territory, provided however that BioNova’s access to any Expression Technology for such Regulatory Filings will be provided through the Disclosure Process, with which BioNova will provide its assistance upon Sutro’s request.

  Section I.39.License Grant to Sutro. During the Term, BioNova hereby grants to Sutro a non-exclusive, fully paid-up, royalty-free, sublicensable (through multiple tiers), transferable license under the BioNova Technology to Develop, Manufacture and Commercialize the Licensed Compound and Licensed Products in the Field and in and outside the Territory, subject to the rights of BioNova under the licenses granted to it during the Term.

  Section I.40.Reservation of Rights. No rights, other than those expressly set forth in this Agreement, are granted to either Party under this Agreement, and no additional rights will be deemed granted to either Party by implication, estoppel or otherwise, with respect to any intellectual property rights. All rights not expressly granted by either Party, or its Affiliates to the other Party under this Agreement are hereby reserved. Notwithstanding anything to the contrary set forth in this Agreement, Sutro retains the right (on behalf of itself, its Affiliates and its licensees (other than BioNova), and its and their Sublicensees) under the Licensed Technology, with the right to grant licenses and sublicenses through multiple tiers, to Manufacture and have Manufactured the Licensed Compounds and Licensed Products anywhere in the world, including in the Territory, (a) for supply to and use by BioNova as contemplated under this Agreement or the Commercial Supply Agreement, or (b) for any and all uses outside the Territory including by Sutro, its Affiliates and its licensees (other than BioNova) and its and their Sublicensees). Neither Party nor any of its Affiliates will use or practice any Know-How or Patent Rights licensed or provided to such Party or any of its Affiliates outside the scope of or otherwise not in compliance with the rights and licenses granted to such Party and its Affiliates under this Agreement.

  Section I.41.No Inconsistent Third Party Agreements. During the Term, each Party will not, and will cause its Affiliates and its and their Sublicensees not to, sell, license or engage in any other transaction or action relating to any (a) intellectual property or (b) any Regulatory Filing, Regulatory Approval, Marketing Authorization and all corresponding documentation, in each case ((a) and (b)), in any way that would contravene, adversely affect or be inconsistent or in conflict with the rights of the other Party or the obligations of the other Party under this Agreement, or agree to do any of the foregoing. 

  Section I.42.Transfer of Licensed Know-How. 

  (G)Initial Technology Transfer. As promptly as reasonably practicable after the Effective Date, but no later than [*] thereafter, Sutro will disclose and make available to BioNova the Licensed Know-How and Regulatory Filings Controlled by Sutro or its Affiliates that exist as of the Effective Date and are reasonably necessary for BioNova to prepare the Regulatory Filings required by the NMPA and execute the Territory-Specific Development Plan. Sutro may make such Licensed Know-How and Regulatory Filings available in such reasonable form as maintained by Sutro or its Affiliates or Sublicensees and reasonably acceptable to BioNova. Sutro will provide BioNova with reasonable access to Sutro’s or its Affiliates’ personnel involved in the Development or Manufacture of such Licensed Compound and Licensed Product, either in-person at Sutro’s or its Affiliates’ facilities or by 

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  teleconference, [*] as reasonably necessary for BioNova to understand and use such Licensed Know-How and Regulatory Filings as contemplated under this Agreement. BioNova acknowledges and agrees that any Know-How relating to the Manufacture of the Licensed Product beyond what is reasonably required for the Regulatory Filings (portions of which relate to the Expression Technology will be provided through the Disclosure Process), will be provided only after BioNova has exercised the License Option and only pursuant to the terms and conditions of the Manufacturing License. 

  (H)Updates. In addition, Sutro will provide updates throughout the Term to BioNova of any Know-How and Regulatory Filings that Sutro or its Affiliates comes to Control that constitutes Licensed Know-How (such updates to be made reasonably promptly after any Calendar Quarter in which such Know-How and Regulatory Filings comes into Control of Sutro or its Affiliates), and Sutro will (i) [*], make reasonably available to BioNova all such Licensed Know-How and Regulatory Filings Controlled by Sutro or its Affiliates and not previously provided to BioNova hereunder, and (ii) provide BioNova with reasonable access to Sutro’s or its Affiliates’ personnel involved in the Development or Manufacture of such Licensed Compound and Licensed Product, either in-person at Sutro’s or its Affiliates’ facilities or by teleconference, [*] as reasonably necessary for BioNova to understand and use such Licensed Know-How and Regulatory Filings as contemplated under this Agreement and reasonably necessary for BioNova to prepare the Regulatory Filings required by the NMPA and execute the Territory-Specific Development Plan.

  Section I.43.Exclusivity. 

  (I)Obligations on Sutro. During the Term of this Agreement and subject to the terms and conditions of this Agreement, [*] anywhere in the Territory nor collaborate with, enable or otherwise authorize, license or grant any right to any Third Party to Develop, Manufacture or Commercialize [*] anywhere in the Territory.

  (J)Obligations on BioNova. During the Term of this Agreement and subject to the terms and conditions of this Agreement, neither BioNova nor any of its Affiliates nor Sublicensees will, directly or indirectly, Develop, Manufacture or Commercialize any Competitive Product anywhere in the Territory nor collaborate with, enable or otherwise authorize, license or grant any right to any Third Party to Develop, Manufacture or Commercialize any Competitive Product anywhere in the Territory.

  (K)Change of Control Exception. Notwithstanding the provisions of the foregoing Section 3.9(a) and Section 3.9(b), if either Party undergoes a Change of Control with a Third Party who owns or has rights to a Competitive Product that is in ongoing clinical development or being marketed by such Third Party as of the date of the Change of Control that would cause such Party to be in breach of the foregoing Section 3.9(a) or Section 3.9(b) (as applicable) (each, an “Acquired Competing Product”), then such Party shall be deemed not to be in breach of the foregoing Section 3.9(a) or Section 3.9(b) (as applicable) as a result of the continued Development or Commercialization of any such Acquired Competing Product during the Term; provided that (i) such continued activities are conducted independently of the activities under this Agreement (including maintaining separate lab notebooks), (ii) no Know-How or Confidential Information of the other Party is provided to or shared with any personnel working on the Acquired Competing Product, and (iii) the Party undergoing such Change of Control 

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  implements firewalls, clean room procedures and other protections reasonably acceptable to the other Party that are designed to reasonably facilitate compliance with the foregoing clauses (i) and (ii).

  ARTICLE IV
DEVELOPMENT

  Section I.44.Development Responsibilities in General. 

  (A)Development Diligence. Sutro (directly, or through its respective Affiliates or its or their Sublicensees and contractors) will [*]. BioNova will not be deemed to be in breach of its obligations under this Section 4.1(a) to the extent it is prevented from or delayed in using Commercially Reasonable Efforts to perform an activity assigned to it in the Territory-Specific Development Plan as a result of the [*] or Sutro’s breach of any of its obligations under this Agreement or [*] under the Development Plans.

  (B)Development Responsibilities. Subject to the terms and conditions of this Agreement, including this ARTICLE IV, BioNova will have sole authority and discretion to, at its own expense, Develop the Licensed Product for the purpose of obtaining Regulatory Approval in the Field in the Territory. BioNova will be responsible for the day-to-day implementation of any Development activities for which it (or any of its Affiliates) is assigned responsibility under this Agreement (including the Territory-Specific Development Plan) and will keep Sutro reasonably informed as to the progress of such activities. 

  Section I.45.Development Plans. BioNova has sole discretion to decide, finalize, and update from time to time, the development plan for Development in the Field in the Territory (the “Territory-Specific Development Plan”), and Sutro or its licensee outside the Territory has sole discretion to decide, finalize, and update from time to time, the development plan for Development outside of the Territory (the “Global Development Plan”, and together with the Territory-Specific Development Plan, the “Development Plans”). Notwithstanding the foregoing sentence, the Parties agree to coordinate and cooperate with each other on the preparation and updating of the Territory-Specific Development Plan through the JSC, and in particular, the Parties will discuss the Territory-Specific Development Plan, consider the other Party’s comments in good faith, and will use good faith efforts to make the Development Plans consistent in and outside the Territory, including in respect of requirements previously encountered by Sutro in its Development efforts outside of the Territory. To facilitate such coordination, each Party will provide a copy of the Development Plan for such Party’s territory to the other Party [*]

  Section I.46.Development Records and Reporting.

  (C)Records. BioNova will maintain complete and accurate records of all work conducted by BioNova in furtherance of seeking Regulatory Approval for the Licensed Product in the Field in the Territory including details of all Development activities planned, commenced and completed together with the associated data and results. [*]

  (D)Reporting. BioNova will provide to Sutro a written report [*], in English, describing in reasonable detail BioNova’s activities and progress related to the Development of, and 

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  pursuit of Regulatory Approval for, the Licensed Product in the Field in the Territory. BioNova will respond to Sutro’s [*]

  Section I.47.Development Costs. Except as otherwise provided in this Agreement, BioNova will be [*] including all [*] incurred by BioNova and its Affiliates.

  Section I.48.Global Development Plan and Joint Global Study. The Parties agree to consider the optimal regulatory pathway to achieve Marketing Authorization in the PRC, including the utility and appropriateness of conducting joint global Clinical Studies to which BioNova would contribute subjects; provided, however, any final decision to conduct clinical development outside of the Territory will remain in Sutro’s sole and absolute discretion. In the event that Sutro has decided to proceed with a global Clinical Study, both Parties will collaborate in good faith to assess the clinical development plan for the Territory. Following agreement [*] no less than the minimum number of subjects required by the applicable Regulatory Authorities in the applicable Region in the Territory, including the NMPA, for BioNova to qualify the Clinical Study for the Licensed Product to be conducted in the applicable Region in the Territory as part of the Joint Global Study (along with any data generated by the Joint Global Study outside the Territory) as a Pivotal Study in the applicable Region in the Territory. [*] The Global Development Plan will specify a budget for the Development activities. BioNova will be responsible for[*] as specified in the Global Development Plan. Sutro will be responsible for [*] as specified in the Global Development Plan.

  Section I.49.Regulatory Submissions and Approvals; Communications; Meetings.

  (E)Regulatory Filings and Approvals. BioNova, or its relevant Affiliates or Sublicensees, will have the sole and exclusive right to file and hold all INDs and Regulatory Filings, and to apply for and maintain all INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals, in each case, for all Licensed Products in the Field in the Territory at BioNova’s cost and expense in the name of BioNova or any of its Affiliates and its or their Sublicensees; provided that (i) the Parties will [*] cooperate to effectuate this Section 4.6(a), and (ii) in the event that after the Parties’ [*], BioNova or any of its Affiliates, or its or their Sublicensees is unable under applicable Law to hold or become the legal and beneficial owner of the INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals for the Licensed Products in the Field in the Territory in order to exercise its rights and perform its obligations under this Agreement, then, subject to reasonable advance notice and subject to the terms and conditions of this Section 4.6, only for so long as the foregoing legal inability subsists and subject to all reasonably applicable conditions and limitations: (A) Sutro will be the legal and beneficial owner of the INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals for the Licensed Products in the Field in the Territory, (B) Sutro will designate BioNova or its Affiliates or its or their Sublicensees as Sutro’s regulatory agent and exclusive general distributor for the Licensed Products in the Field in the Territory, and (C) to the extent later permitted by applicable Laws, Sutro will cooperate with BioNova and its Affiliates and its or their Sublicensees, including transferring and assigning all INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals to BioNova or its Affiliates or its or their Sublicensees, to allow BioNova or its Affiliates or its or their Sublicensees to be the legal and beneficial owner of all INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals for the Licensed Products in the Field in the Territory. Sutro understands and acknowledges 

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  that as of the Effective Date, BioNova intends to Develop and obtain Regulatory Approval of the Licensed Product in the PRC as an imported pharmaceutical product, and accordingly, the applicable Laws and practice of the applicable Regulatory Authority in the PRC as of the Effective Date require Sutro to be the holder of the IND and sponsor of the Clinical Trials of the Licensed Product conducted in the PRC and the holder and legal and beneficial owner of the IND and Regulatory Approvals for the Licensed Products as an imported pharmaceutical product in the PRC. Subject to the terms and conditions of this Agreement, BioNova will be responsible, at its sole cost and expense, for all regulatory activities leading up to and including the submitting and obtaining of INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals, as applicable, for the Licensed Products in the Field in the Territory from Regulatory Authorities or Governmental Authorities in the Territory, provided that, BioNova will conduct such activities (and any and all regulatory activities delegated to BioNova in this Agreement) (1) in its own name, if BioNova is the holder and legal and beneficial owner of the INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals for the Licensed Products in the Field in the Territory, or (2) as the express and authorized regulatory agent of record for Sutro in the Field in the Territory, if Sutro is the legal and beneficial owner of the INDs, Regulatory Filings, Regulatory Approvals, and Pricing and Reimbursement Approvals for the Licensed Products in the Field in the Territory, under which situation such actions will be taken on behalf of Sutro and for the benefit of BioNova in the Field in the Territory. 

  (F)Regulatory Communications. Subject to applicable Laws and this Section 4.6, BioNova will oversee, monitor and manage all interactions and communications with Regulatory Authorities with respect to the Licensed Products in the Field in the Territory. Subject to the other provisions in this ARTICLE IV, including Section 4.9, BioNova will have final decision-making authority regarding all regulatory activities, including the labeling strategy and the content of Regulatory Filings for Licensed Products in the Field in the Territory, subject to the terms and conditions of this Agreement. BioNova will promptly notify Sutro of all material communications or correspondence with Regulatory Authorities with respect to the Licensed Product in the Field in the Territory that are received by BioNova from any Regulatory Authority or submitted by BioNova to any Regulatory Authority.

  (G)Regulatory Meetings. Until such time as BioNova obtains Regulatory Approval for the Licensed Product in the Field in the Territory, to the extent legally permissible and practicable, BioNova will provide Sutro with [*] of all material meetings with Regulatory Authorities (including advisory committee meetings and any other meeting of experts convened by a Regulatory Authority) regarding the Licensed Product if permitted by applicable Laws or the Regulatory Authority. At BioNova’s request, Sutro will cooperate and provide reasonable assistance to BioNova in connection with such meetings with Regulatory Authorities, including attending such meetings with Regulatory Authorities to the extent permitted under applicable Laws and by the Regulatory Authority, and BioNova [*] incurred by Sutro personnel in connection with any such attendance. 

  (H)Termination or Suspension of Clinical Studies. Notwithstanding anything to the contrary in this Agreement or the Pharmacovigilance Agreement, the Parties hereby agree that BioNova may terminate or suspend any Clinical Study relating to the Licensed Product in the Field in the Territory, without the approval or consent of the JSC or the other Party, if (i) a Regulatory Authority, institutional review board or safety data review board for such Clinical Study has required or recommended such termination or suspension or (ii) following review and discussion with the JSC, BioNova believes in good 

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  faith that such termination or suspension is warranted because of observed efficacy or safety data or signals in the Clinical Studies. In either case, BioNova will notify Sutro in writing of such termination or suspension prior to public disclosure of such termination or suspension and promptly provide to Sutro a detailed report of the observations and assessments leading to such termination or suspension. 

  (I)Regulatory Investigation or Inquiry. If any Regulatory Authority (i) contacts BioNova or its Affiliate or its or their Sublicensee with respect to the alleged improper Development, Manufacture, or Commercialization of any Licensed Product, (ii) conducts, or gives notice of its intent to conduct, an inspection at BioNova’s or its Affiliate’s or its or their Sublicensee’s facilities used in the Development of the Licensed Product, or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of BioNova or its Affiliate or its or their Sublicensee that could reasonably be expected to adversely affect any Development, Manufacture, or Commercialization activities with respect to the Licensed Product in or outside of the Territory, then BioNova will [*] Sutro in writing of such contact, inspection or notice with all material details available to BioNova.

  Section I.129.Delivery of Documentation. [*] during the Term, upon a Party’s reasonable request, the other Party will promptly provide the requesting Party with copies of all data and information (including communications with Regulatory Authorities, existing Regulatory Filings, and clinical and pre-clinical data and supporting documentation, in each case, in the form such data and information is maintained) relating to Licensed Products that are (i) Controlled by and in the possession of the other Party, its Affiliates or its Sublicensees and (ii) necessary or reasonably useful to support the requesting Party’s Development, Manufacture or Commercialization of, or Regulatory Approval or Marketing Authorization for, Licensed Products, in the case that BioNova is the requesting Party, in Field and the Territory, and in the case that Sutro is the requesting Party, outside the Territory.

  Section I.130.Development of the Licensed Products Outside the Territory. Subject to Section 4.9, Sutro retains the exclusive right and will be solely responsible and have sole discretion and control over the Development activities (including regulatory activities) of the Licensed Products anywhere in the world other than in the Territory. Sutro will, in its sole discretion, oversee, monitor and manage all interactions and communications with Regulatory Authorities with respect to such Licensed Products outside of the Territory. Sutro will have final decision-making authority regarding all regulatory activities, including the labeling strategy and the content of Regulatory Filings with respect to such Licensed Products outside of the Territory, including in connection with the conduct of a Joint Global Study (with BioNova accepting Sutro’s invitation to participate in a global Clinical Study).

  Section I.131.No Harmful Actions. Each Party will [*] the other Party of all material communications or correspondence with any Regulatory Authority with respect to the Licensed Product in such Party’s territory that would [*] the Development, Manufacture or Commercialization of the Licensed Products in the Field anywhere in the world including outside of the Territory. In the event either Party or its Affiliates’ or its or their Sublicensees Development activities (including regulatory activities) of the Licensed Product in the Field would reasonable be expected to materially adversely impact the Development, Manufacture or Commercialization of the Licensed Products in or outside the Field anywhere in the world including outside of the Territory, such Party will promptly notify the other Party of any such activities and, prior to undertaking such activities, in good faith consider the other Party’s comments. [*] following such notice, the Parties will discuss at the JSC an action plan to address 

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  such Development activities (including regulatory activities) to minimize the impact on the other Party’s Development timeline and other activities of the Licensed Product. In the event the Parties fail to agree on the magnitude or likelihood of the material adverse impact of such proposed activities or an action plan, and such failure to agree persists after escalation to the Senior Officer of each Party, then, [*]

  Section I.132.Pharmacovigilance. Within [*] after the Effective Date, the Parties will negotiate [*] with respect to the Licensed Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”). These responsibilities will include [*] guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of Adverse Event reports and any other information concerning the safety of any Licensed Product, including recall and withdrawal responsibilities, processes and procedures. Such guidelines and procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. BioNova will be responsible for reporting quality complaints, Adverse Events and Safety Data related to the Licensed Product in the Field to applicable Regulatory Authorities in the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Products in the Field in the Territory. Sutro will be responsible for reporting quality complaints, Adverse Events and Safety Data related to Licensed Product to applicable Regulatory Authorities outside the Territory, as well as responding to safety issues and to all requests of Regulatory Authorities relating to Licensed Product outside the Territory. The Pharmacovigilance Agreement will also provide for a worldwide safety database to be maintained by Sutro, which worldwide safety database may be made accessible by BioNova, its Affiliates, and its or their Sublicensees and contractors to the full extent necessary for BioNova to exercise its rights under this Agreement, comply with its obligations under this Agreement and comply with all applicable Laws subject to a [*] in the Pharmacovigilance Agreement. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and its or their Sublicensees and contractors to comply with such obligations.

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  ARTICLE V
MANUFACTURE AND SUPPLY 

  Section I.50.Clinical Supply.

  (A)General. In accordance with the provisions in this Section 5.1, Sutro will, or cause its designee to, Manufacture and supply BioNova with all of BioNova’s, its Affiliates’ and its or their Sublicensees’ reasonable requirements of Licensed Product to use in connection with the Development in the Field in the Territory (the “Clinical Supply”). BioNova acknowledges that Sutro’s responsibility [*] by Sutro in its Development activities in the United States as of the Effective Date, and with the existing label (it being understood that Sutro makes no claim or statement that the existing label contains the necessary information required for importation in the Territory). The necessary information required for importation of the Licensed Product in the PRC is included in the sample label for the PRC attached hereto as Exhibit G. In the event that the existing label does not contain the necessary information required for importation of the Licensed Product in a Region in the Territory, Sutro will label or relabel the Licensed Product using the sample label for such Region in the Territory provided by BioNova (or in the case of the PRC, using the sample label for the PRC attached hereto as Exhibit G). In addition and in accordance with the provisions in this Section 5.1, Sutro will (i) [*] (the “Initial Clinical Supply”) [*] following the Effective Date, and (ii) [*]. With respect to all Clinical Supply, including the Initial Clinical Supply, consistent with the foregoing provisions of this Section 5.1(a), [*] to ensure that the Clinical Supply is ready for use in clinical trials in the Territory, including the QA/QC (to the extent specifically required for the Territory) and release testing, packaging & labeling (including translation and printing), shipment, export and import, warehousing, insurance and other similar costs and charges associated with such quantities of Licensed Product from the applicable CMO directly to the facilities of BioNova, its Affiliates and its or their Sublicensees in the Territory, which Other Costs is understood to be excluded (notwithstanding any other provision in this Agreement to the contrary) from Sutro’s Fully Burdened Manufacturing Cost, and accordingly all such Other Costs will be paid by BioNova upon invoice by Sutro. Unless otherwise agreed by the Parties or provided under this Agreement, the provisions of this Section 5.1 will apply only to Clinical Supply.

  (B)Manufacturing by CMOs. BioNova acknowledges and agrees that Sutro’s sources the manufacture and supply of Licensed Product from its CMOs. Accordingly, notwithstanding any provision in this Agreement to the contrary, BioNova hereby accepts that Sutro’s capacity to provide the Initial Clinical Supply and the Clinical Supply thereafter as specified in this Agreement shall in all events be subject to the manufacturing capacities of each such CMO at the material times and the limitations in Sutro’s contracts with its CMOs. In no event will Sutro be considered to be in breach of its obligations to supply quantities of Licensed Products to BioNova under this Agreement in connection with the Initial Clinical Supply and Clinical Supply provisions set forth in this Agreement if any delay or inability to supply is attributable to capacity constraints with Sutro’s CMOs or limitations in Sutro’s contracts with its CMOs. 

  (C)Purchase Orders. BioNova will place purchase orders (each, a “Purchase Order”) in quantities of the Licensed Product in the form set forth in the attached Exhibit H. Each Purchase Order submitted by BioNova must be placed at least [*] prior to the requested date of delivery. Subject always to the caveats set forth in this Section 5.1, Sutro will use Commercially Reasonable Efforts to accept any 

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  Purchase Order for reasonable quantities with reasonable lead times submitted by BioNova. If Sutro fails to provide an acceptance or rejection of a Purchase Order within [*] after receipt by Sutro, such Purchase Order will be deemed accepted. Purchase Orders that are accepted are binding on the Parties and may not be cancelled without the prior written agreement of both Parties (such binding Purchase Orders, “Binding Orders”), provided that in the event of a delay of a Clinical Study arising from circumstances beyond BioNova’s reasonable anticipation or control, a Binding Order may be cancelled by BioNova subject to BioNova’s payment of (i) all applicable [*] which cancellation fees are subject to change without notice based on changes in the underlying CMOs or the agreements therewith, and (ii) [*] to the extent Sutro is not able to utilize the quantities of Licensed Product ordered in such cancelled Binding Order elsewhere, using Commercially Reasonable Efforts. If any term or condition contained in any Purchase Order or any other document exchanged between the Parties under this Agreement is inconsistent with this Agreement, then the terms and conditions provided in this Agreement will control. No additional term or condition set forth in any such document will be binding upon either Party unless agreed to in writing by the Parties.

  (D)Delivery; Risk of Loss. Licensed Product will be delivered, transfer of title will occur, and [*]

  (E)Product Warranty. Sutro hereby undertakes to ensure, and represents and warrants, that all Licensed Product delivered to BioNova under this Agreement at the time of delivery (i) conforms with the Specifications, (ii) is Manufactured in accordance with applicable Regulatory Standards and this Agreement and is not adulterated or misbranded under applicable Laws, (iii) is delivered with full title, free and clear of any liens, charges, encumbrances or security interests, and (iv) has at least [*] drug product shelf-life remaining (collectively (i) through (iv), the “Manufacturing Requirements”).

  (F)Changes. With respect to any changes to the Specifications of Licensed Products, the Manufacturing process for Licensed Products, or the CMO or facility used to Manufacture Licensed Products, in each case, then being supplied to BioNova as part of the Clinical Supply, which changes are required by a Regulatory Authority or Manufacturing Requirements in a Region (“Required Manufacturing Changes”), Sutro will use good faith efforts to consider implementing such Required Manufacturing Changes but BioNova acknowledges and agrees that Sutro shall have no obligation to implement such changes. BioNova further agrees that Sutro will have no liability to BioNova for not implementing any Required Manufacturing Change and understands that if the Licensed Product as manufactured for Sutro as of the Effective Date does not satisfy requirements for their use in Development in the Territory (other than labeling, which is addressed in accordance with Section 5.1(a) and Section 5.1(h)), BioNova will make alternative arrangements for manufacture and supply of Licensed Products compatible for use in the Territory for which effort Sutro will reasonably assist subject to terms and conditions to be mutually agreed. For the duration of Clinical Supply as contemplated under Section 5.1(a), Sutro will not implement any change to the Specifications or the Manufacturing process for Licensed Product or any change of the CMO or facility used to Manufacture the quantities of Licensed Product to be supplied to BioNova as part of the Clinical Supply without first notifying BioNova in advance of delivery. BioNova will be responsible for the costs and expenses of implementing any changes under this Section 5.1(f) that are (i) requested by BioNova (including any Required Manufacturing Changes) or (ii) specific solely to the Territory, in each case if agreed to be implemented by Sutro, and Sutro will otherwise be responsible for such costs and expenses for all other changes.

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  (G)Acceptance and Rejection. BioNova will have the right to reject all or part of any shipment of Licensed Product it orders and receives from Sutro based on the grounds that such Licensed Product fails to conform to any of the Manufacturing Requirements (a “Defect,” and any unit with a Defect, a “Non-Conforming Product”). BioNova will deliver written notice to Sutro of any rejection permitted in this Section 5.1(g) for any Non-Conforming Product within [*] from the date of delivery of the same. If a dispute arises as to whether the Licensed Product is a Non-Conforming Product that is not resolved by good faith negotiations between the Parties within [*] of the delivery by BioNova of the notice of rejection for non-conformance, then the matter (along with related samples, batch records, and/or other evidence, as appropriate) will be submitted to an independent testing laboratory mutually agreed to by the Parties. The determination of the independent testing laboratory will be binding upon the Parties, save for manifest error. If the Parties agree or the independent laboratory confirms that any Licensed Product is a Non‐Conforming Product, [*] replace the Non-Conforming Product as soon as practicable. The cost and expenses of the laboratory that conducts the testing described above will be borne by the Party deemed to be the cause of such non-conformance, and if the cause cannot be determined, then such costs will be shared equally between the Parties. Any Licensed Product that is determined to be Non-Conforming Product that is in BioNova’s control will, at Sutro’s option, [*]

  (H)Packaging, Product Labels and Inserts, and Artwork. With respect to Sutro’s supply to BioNova of quantities of Licensed Product beyond the Initial Clinical Supply provided for above, by a date mutually agreed upon by the Parties, BioNova will provide Sutro with labeling specifications and draft labels and inserts, including artwork, as required in the Territory and that comply with all applicable Laws. BioNova will additionally provide all materials and information so as to enable Sutro to (i) liaise with its packaging material suppliers and printers, (ii) arrange for printing and preparing such packaging, labels and inserts, and (iii) coordinate delivery of such packaging, labels and inserts to Sutro’s CMO so that the Licensed Product supplied for use in Clinical Studies in the Territory, beyond those quantities supplied as part of the Initial Clinical Supply, will be delivered fully packaged and labeled.

  (I)Payment; Invoices. Sutro will promptly invoice BioNova for the Clinical Transfer Price for all applicable quantities of Licensed Product delivered in accordance with this Section 5.1. BioNova acknowledges and agrees that in addition to [*], any and all Other Costs associated with delivering quantities of Licensed Product to BioNova, its Affiliates and its or their Sublicensees incurred by Sutro, including freight, taxes and other charges paid by Sutro to its CMOs, will be passed on to BioNova and will be BioNova’s responsibility to pay. The undisputed portions of such invoices will be due and payable within [*] of the invoice date, and any such undisputed amounts not paid when due will accrue interest in accordance with Section 8.10.

  (J)Quality Agreement. Within [*] after the Effective Date, the Parties will negotiate in good faith and finalize a quality agreement with respect to the quality assurance, quality control and technical requirements of the Licensed Product supplied by Sutro as part of the Clinical Supply (the “Quality Agreement”). In the event of any conflict between this Agreement and the Quality Agreement, the terms and conditions of this Agreement will govern and control except with respect to quality assurance requirements which shall be governed and controlled by the Quality Agreement.

  Section I.51.Commercial Supply. No later than [*] prior to the date BioNova anticipates its First Commercial Sale of Licensed Products in the Territory but not prior to Sutro’s receipt of the License 

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  Option Exercise Notice and the applicable License Option Exercise Payment, the Parties will negotiate in good faith and enter into a commercial supply agreement for such supply (the “Commercial Supply Agreement”) on such terms as are reasonable and customary for commercial supply of pharmaceutical products and at a supply price not to exceed (a) [*] of Sutro’s Fully Burdened Manufacturing Costs plus Other Costs for the Manufacture and supply of quantities of Licensed Product finished by CMOs engaged by Sutro and intended for commercial sale in the Territory, and (b) [*] of Sutro’s Fully Burdened Manufacturing Costs [*] of Other Costs for the Manufacture and supply by Sutro of quantities of bacterial extracts, reagents, antibody for use in the further Manufacture of Licensed Products intended for commercial sale in the Territory.

  Section I.52.Audit by BioNova. With respect to any Clinical Supply that BioNova is supplied by Sutro pursuant to this Agreement, Sutro will keep reasonably sufficient records, materials and documents necessary to calculate the Fully Burdened Manufacturing Cost for such Clinical Supply and all Other Costs related to supplying such Clinical Supply to BioNova that BioNova is responsible for [*] thereafter. BioNova will have the right annually to have an independent, certified public accountant, selected by BioNova and reasonably acceptable to Sutro to inspect such records, materials and documents for the sole purpose of determining the accuracy of Sutro’s Fully Burdened Manufacturing Cost and such Other Costs for Clinical Supply supplied within the [*]. Such audit may not be conducted more than [*] and will take place at the location(s) where such records, materials, documents are maintained by Sutro upon [*], during regular business hours and with such certified public accountant being bound by written obligations of confidentiality substantially similar to those under this Agreement and reasonably acceptable to Sutro, and subject to the understanding that the results of such accountant’s review will state whether there was an overpayment or underpayment and, if known, the source of the error. If it is determined that any amounts were overpaid or underpaid during such period, Sutro will pay BioNova such overpaid amounts, or BioNova will pay Sutro the underpaid amounts within [*] after the date the independent certified public accountant’s written report is received by the paying Party. The fees charged by such independent certified public accountant will be paid by BioNova, unless it is determined that any overpaid amounts exceed [*] of the total amount payable by BioNova to Sutro for the period then being audited, in which case Sutro will be responsible for the fees charged by such independent certified public accountant. The records covering any specific period of time may be audited no more than once.

  Section I.53.Regulatory Audit. During the Term, if BioNova receives any audit notice from any Regulatory Authority in the Territory with respect to the Manufacturing of any Product, then, BioNova will [*] notify Sutro of such audit notice. For any such audit of Sutro or its Affiliates or Sutro’s or its Affiliates’ own facilities, Sutro will (a) facilitate any such audit and (b) permit a reasonable number of representative(s) appointed by the applicable Regulatory Authority, or, upon written approval by Sutro, representative(s) of BioNova (at BioNova’s sole expense), to be present at any such audit. For any such audit of Sutro’s CMO or its facilities, Sutro will use Commercially Reasonable Efforts to discuss with its CMO the conduct of such audit, and if its CMO permits such audit or Sutro otherwise has the right to require its CMO under its agreement with such CMO to facilitate such audit, Sutro will (i) facilitate any such audit of its CMO and (ii) permit a reasonable number of representative(s) appointed by the applicable Regulatory Authority, or, upon written approval by Sutro and its CMO, representative(s) of BioNova (at BioNova’s sole expense), to be present at any such audit. All representatives of BioNova participating in any such audits will agree in writing to be bound by confidentiality obligations substantially similar to those under this Agreement or otherwise requested by Sutro’s CMO and any such 

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  audit will need to be scheduled and conducted in a manner that is in compliance with and as permitted under Sutro’s agreement with such CMO. Any reference samples, manufacturing records and books, or audit results or reports disclosed to BioNova pursuant to this Section 5.4 will be considered as Confidential Information of Sutro for purpose of this Agreement.

  Section I.54.Manufacturing License and Technology Transfer. Upon BioNova’s written notice to Sutro, and following payment of the License Option Exercise Payment, Sutro and BioNova shall discuss and agree on the terms and conditions of a technology transfer and license agreement that will permit BioNova to Manufacture (by itself, or through Affiliates or Third Parties) the Licensed Compound and Licensed Product in the Territory. Unless otherwise agreed by the Parties, Sutro will, within [*] following execution of such technology transfer and license agreement, provide access to and transfer to BioNova, or an Affiliate or a CMO all Know-How Controlled by Sutro or its Affiliates that is necessary or reasonably useful for such entity to Manufacture the Licensed Compound and the Licensed Products in the Territory. Such agreement shall provide that, upon reasonable request from BioNova and at BioNova’s cost, Sutro will provide to BioNova all necessary and reasonably requested assistance and services and all reasonable access to Sutro’s or its Affiliates’ or its or their CMOs’ personnel involved in the Manufacture of such Licensed Compound and Licensed Product to enable BioNova or its Affiliates or Sublicensees to Manufacture the Licensed Compound and the Licensed Product in substantially the same manner and quality as Sutro or its Affiliate or its or their CMOs Manufactures the Licensed Compound and the Licensed Product for Sutro or its Affiliates or Sublicensees. Sutro will provide a Manufacturing technology transfer plan to facilitate the foregoing for the Parties’ good faith discussion and the Parties will negotiate in good faith and agree to such a plan. No additional financial consideration shall be due in connection with the license permitting BioNova to Manufacture the Licensed Compound and Licensed Product in the Territory.  

  Section I.55.[*]. If the Parties after reasonable and good faith effort have failed to agree upon any one or more terms of the technology transfer and license agreement contemplated by Section 3.1 and Section 5.5 (the “Manufacturing License”), the matter shall be submitted to and finally resolved by [*] arbitration in accordance with the following provisions. [*]. Within [*] of the arbitrator’s appointment, each Party shall prepare and deliver to both the arbitrator and other Party its last, best offer for the applicable unresolved term(s) of the Manufacturing License and a memorandum in support thereof. The Parties shall also provide the arbitrator with a copy of the relevant provisions of this Agreement. Each Party may submit to the arbitrator (with a copy furnished to the other Party) a rebuttal to the other Party’s support memorandum and will at such time have the opportunity to amend its last such offer based on any new information contained in the other Party’s support memorandum. Within [*] after the arbitrator’s appointment, the arbitrator will [*]. 

  Section I.56.Direct CMO Engagement. Without limiting Section 2.6, after BioNova has paid to Sutro the License Option Exercise Payment, upon BioNova’s written request and at BioNova’s election, Sutro will permit BioNova or its Affiliate and Sublicensees to enter into a supply agreement directly with one or more CMOs engaged by Sutro or its Affiliates or Sublicensees for clinical and/or commercial supply of the Licensed Compound and Licensed Product for the Territory. Upon BioNova’s request, Sutro will introduce BioNova to such CMOs for BioNova to commence such discussions and provide BioNova and such CMOs with its consent to allow such CMOs to Manufacture and supply Licensed Compound and Licensed Product directly to BioNova and its Affiliates and Sublicensees and for 

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  BioNova and its Affiliates and Sublicensees to directly purchase Licensed Compound and Licensed Product from such CMOs.

  ARTICLE VI
Commercialization

  Section I.57.Commercialization Diligence. Within [*] following receipt of the Regulatory Approval by the NMPA for a Licensed Product in the Field in the PRC, BioNova (directly, or through its Affiliates, or its or their Sublicensees or contractors) will effect Commercial launch and achieve First Commercial Sale in the PRC. Additionally, following receipt of Regulatory Approvals from the appropriate Regulatory Authorities for a Licensed Product in the Field in the other three Regions in the Territory, BioNova will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in the other three Regions in the Territory. Subject to the foregoing sentences and other provisions of this Agreement, BioNova will be solely responsible for, at its expense, and will have sole discretion with respect to, Commercializing the Licensed Product in the Field in the Territory. 

  Section I.58.Notification. BioNova will provide Sutro with written notice of the First Commercial Sale of each Licensed Product in the Field in the Territory within [*] after such event.

  Section I.59.Trademarks. 

  (A)BioNova will have the right to brand the Licensed Products in the Field in the Territory using BioNova related Trademarks and any other Trademarks and trade names it determines appropriate for the Licensed Products, which branding may vary by Region or within a Region. BioNova will own all rights in such Trademarks and register and maintain such Trademarks in the countries and regions within the Territory, where and how it determines appropriate, subject to Section 14.4(k). 

  (B)BioNova will also have the right to brand the Licensed Products in the Field and in the Territory using the Licensed Marks, and BioNova will comply with Sutro’s reasonable trademark usage guidelines in effect from time to time as provided by Sutro. Sutro will own and retain all rights to the Licensed Marks (together with all goodwill associated therewith) in the Territory, and will prepare, file, prosecute and maintain all Licensed Marks in the Territory at its own expense; provided, however, Sutro will provide to BioNova copies of all applications, submissions, communications, and correspondence intended to be sent to, sent to or received by Governmental Authorities or Third Parties in connection with such filing, prosecution, and maintenance of the Licensed Marks in the Territory so that BioNova may review and comment thereon (which will be provided with sufficient advanced notice so that BioNova may meaningfully review and comment, to the extent practicable), and will incorporate any reasonable comments provided by BioNova with respect to such applications, submissions, communications, or correspondence. Subject to terms and conditions of this Agreement, Sutro will grant and hereby grants a non-exclusive, sublicensable (subject to Section 3.2), fully paid-up, royalty free, non-transferrable (subject to Section 16.1(a)) license under the Licensed Marks for BioNova to Commercialize the Licensed Products in the Field in the Territory. BioNova will comply with Sutro’s guidelines on the use and display of the Licensed Marks and quality control instructions.

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  Section I.60.Diversion. Subject to applicable Law, each Party hereby covenants and agrees that (A) it and its Affiliates will not, and it will contractually obligate (and use Commercially Reasonable Efforts to enforce such contractual obligation) its licensees, and its or their Sublicensees and contractors not to, directly or indirectly, actively promote, market, distribute, import, sell or have sold any Licensed Product, including via the Internet or mail order, to any Third Party or to any address or Internet Protocol address or the like, in the other Party’s territory, and (B) neither Party will engage, nor permit its Affiliates, or its or their Sublicensees or contractors to engage, in any advertising or promotional activities relating to any Licensed Product for use directed primarily to customers or other buyers or users of such product located in any country, Region or jurisdiction in the other Party’s territory, or solicit orders from any prospective purchaser located in any country, Region or jurisdiction in the other Party’s territory. Notwithstanding the foregoing, nothing in this Section 6.4, will prevent Sutro, its Affiliates and licensees from undertaking, or having undertaken, any of the foregoing activities with respect to any Licensed Product outside of the Field in the Territory. 

  Section I.61.No Violation. Notwithstanding anything to the contrary contained herein, BioNova (including its Affiliates, its or their Sublicensees and contractors) will not be obligated to undertake or continue any Commercialization activities with respect to Licensed Products if BioNova (or its Affiliates, its or their Sublicensees or contractors, as applicable) reasonably determines that performance of such Commercialization activity would violate applicable Laws or infringe any Third Party Patent Rights.

  ARTICLE VII
GOVERNANCE; JOINT STEERING COMMITTEE

  Section I.62.Formation; Purposes and Principles. As soon as practicable following the Effective Date (but in no event later than [*] after the Effective Date), Sutro and BioNova will form a joint steering committee (the “JSC”) to serve as a forum for discussion and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement. 

  Section I.63.Specific Responsibilities. In addition to its overall responsibility to provide a forum for discussion and to facilitate information sharing between the Parties with respect to the activities of the Parties under this Agreement, the JSC will:

  (A)coordinate and share information with respect to the Development and Commercialization of the Licensed Product by BioNova in the Territory; 

  (B)keep each Party reasonably informed of the other Party’s Development and Commercialization activities and interactions with Regulatory Authorities in the other Party’s territory, by receiving updates from the Party conducting such activities; 

  (C)attempt to discuss in the first instance all matters between the Parties that are in dispute; 

  (D)review and discuss the Territory-Specific Development Plan and any proposed amendments thereto;

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  (E)review and discuss the Global Development Plan, to the extent relevant to the Territory-Specific Development Plan;

  (F)review and discuss matters that may have a material adverse impact upon the regulatory status of the Licensed Products pursuant to Section 4.9; 

  (G)review and discuss any proposed publication of the results of Development or Commercialization carried out on the Licensed Product by BioNova, its Affiliates and its and their respective Sublicensees; and

  (H)perform such other functions as are assigned to it in this Agreement or as appropriate to further the purposes of this Agreement to the extent agreed to in writing by the Parties.

  Section I.64.Membership. The JSC will be composed of a total of three (3) representatives of each Party, which will be appointed by each of Sutro and BioNova, respectively. Each individual appointed by a Party as a representative to the JSC will be an employee of such Party with sufficient seniority within the applicable Party to provide meaningful input and make decisions arising within the scope of the JSC’s responsibilities, and have knowledge and expertise in the Development, Manufacture or Commercialization of compounds and products similar to the Licensed Compound and Licensed Products under this Agreement. Each Party may replace any of its JSC representatives at any time upon written notice to the other Party, which notice may be given by e-mail, sent to the other Party’s co-chairperson. The JSC will be co-chaired by one designated representative of each Party. The two co-chairpersons of the JSC, one from each Party, will cast its Party’s vote in the JSC and such designee will have the authority to make decisions on behalf of such Party on matters before the JSC. Each co-chairperson will on an alternate basis be responsible for calling and conducting meetings. Each JSC representative will be subject to confidentiality obligations no less stringent than those in ARTICLE X. 

  Section I.65.Meetings; Reports. The JSC will hold meetings at least once per Calendar Quarter during the Term for so long as the JSC exists, unless the Parties mutually agree in writing to a different frequency. No later than [*] prior to any meeting of the JSC (or such shorter time period as the Parties may agree), the applicable co-chairperson or Alliance Manager will prepare and circulate an agenda for such meeting. Either Party may also call a special meeting of the JSC by providing at least [*] prior written notice to the other Party if such Party reasonably believes that a significant matter must be addressed prior to the next scheduled meeting, in which event such Party will work with the applicable co-chairperson of the JSC or Alliance Manager to provide the members of the JSC no later than [*] prior to the special meeting with an agenda for the meeting and materials reasonably adequate to enable an informed decision on the matters to be considered. The JSC may meet in person or by audio or video conference as its co-chairpersons may mutually agree. Other representatives of the Parties, their Affiliates, or Third Parties involved in the Development, Manufacture, or Commercialization of Licensed Products may be invited by the members of the JSC to attend meetings as non-voting observers; provided, however, that such representatives are subject to confidentiality obligations no less stringent than those set forth in ARTICLE X. No action taken at a meeting will be effective unless at least one representative of each Party (which representative is not such Party’s Alliance Manager) is present or participating. Neither Party will unreasonably withhold attendance of at least one representative of such Party at any meeting of the JSC for which reasonable advance notice was provided. 

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  Section I.66.No Decision-Making Authority. The JSC will function as a forum for discussion, to facilitate the exchange of information, and to facilitate coordination of each Party’s activities under this Agreement. The JSC will not have any decision-making authority, and the JSC will not have the authority to waive any Party’s rights or obligations or amend the terms or conditions of this Agreement.

  Section I.67.Alliance Managers.

  (I)Appointment. Each Party will appoint a person to oversee interactions between the Parties for all matters related to the Development and Commercialization of Licensed Products between meetings of the JSC (each, an “Alliance Manager”). The Alliance Managers will have the right to attend all meetings of the JSC as non-voting participants and may bring to the attention of the JSC any matters or issues either Alliance Manager reasonably believes should be discussed and will have such other responsibilities as the Parties may mutually agree in writing. Each Party may replace its Alliance Manager at any time or may designate different Alliance Managers with respect to Development and Commercialization matters, respectively, by notice in writing to the other Party.

  (J)Responsibility. The Alliance Managers will have the responsibility of creating and maintaining a constructive work environment within the JSC and between the Parties for all matters related to this Agreement. Without limiting the generality of the foregoing, each Alliance Manager will:

  (i)provide a single point of communication within the Parties’ respective organizations and between the Parties with respect to this Agreement;

  (ii)coordinate cooperative efforts, internal communications and external communications between the Parties with respect to this Agreement; 

  (iii)on an alternate basis be responsible for (1) preparing and circulating an agenda in advance of each JSC meeting; provided, however, that the applicable co-chairperson will include any agenda items proposed by either Party on such agenda, (2) [*], and (3) [*] (iii) of this Section 7.6(b) will be deemed approved unless one or more members of the JSC objects to the accuracy of such minutes within [*] after receipt or there is evidence of an inaccuracy; and the Alliance Managers will work with the co-chairpersons [*]; and

  (iv)take such other steps as may be required to ensure that meetings of the JSC occur as set forth in this Agreement, that procedures are followed with respect to such meetings (including working with the co-chairpersons with respect to the giving of proper notice [*]) and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed.

  ARTICLE VIII
FINANCIAL PROVISIONS

  Section I.1.License Option Exercise Payment. In the event BioNova exercises the License Option pursuant to Section 2.5, BioNova will pay to Sutro [*] (the “License Option Exercise Payment”) within [*] following receipt of an applicable invoice from Sutro. Sutro will provide BioNova with an invoice for the License Option Exercise Payment following BioNova’s exercise of the License Option pursuant to Section 2.5.

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  Section I.68.Development Milestone Payments. During the Term, BioNova will notify Sutro in writing of the achievement by or on behalf of BioNova, its Affiliates or its or their Sublicensees of any milestone event set forth in this Section 8.2 in respect of a Licensed Product (each, a “Development Milestone Event”) promptly and not later than [*] after the occurrence thereof, and BioNova will pay Sutro each of the milestone payments set forth in the table below (each, a “Development Milestone Payment”) within [*] of the achievement of such Development Milestone Event by BioNova, its Affiliates or any of its or their Sublicensees and after BioNova receives an invoice therefor from Sutro. Periodically during the Term and at least once quarterly, BioNova will provide to Sutro written summaries updating its progress on Development activities in the Territory including an updated table identifying the Calendar Quarter in which each of the Development Milestone Events is then projected to occur. Each of the Development Milestone Payments set forth in this Section 8.2 is payable only once upon the first achievement of such Development Milestone Payment by the first Licensed Product to achieve such Development Milestone Event, and none of such Development Milestone Payments will be payable more than once regardless of how many times such Development Milestone Event is achieved by the Licensed Products (regardless of the number of such Licensed Products).

  		
	Development Milestone Event
	Development Milestone Payment

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	Total:
	[*]

   

  Section I.1.Sales Milestone Payments. During the Term, BioNova will notify Sutro in writing of its achievement of each of the sales milestones below within [*] after the end of the Calendar Year in which the aggregated annual Net Sales of all Licensed Products in the Territory first exceed the indicated Dollar value (each, a “Sales Milestone Event”). On a Licensed Product-by-Licensed Product basis, BioNova will pay to Sutro each of the milestone payments set forth below within [*] after the end of the Calendar Year in which the Sales Milestone Event occurs and after BioNova receives an invoice therefor from Sutro (each, a “Sales Milestone Payment”). Each of the Sales Milestone Payments for Licensed Products set forth in this Section 8.3 is payable only once upon the first achievement of such Sales Milestone Event with respect to all Licensed Products, in the aggregate, and none of such Sales Milestone Payments will be payable more than once regardless of how many times such Sales Milestone Event is achieved with respect to all Licensed Products, in the aggregate.

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	Sales Milestone Event
	Sales Milestone Payment for Licensed Products

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	Total
	[*]

  Section I.69.Royalties.

  (A)Royalty Rate. Subject to the terms and conditions of this Agreement, during the Royalty Term, BioNova will pay to Sutro a royalty on the Net Sales of all Licensed Products in the Territory that is the product of the aggregate annual Net Sales of all Licensed Products in the Territory and the applicable royalty rate for Licensed Products in the following table, subject to the provisions of Section 8.6.

  		
	Portion of the Annual Net Sales of Licensed Products
	Royalty Rate for Licensed Products

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

   

  (A)Royalty Term. On a Licensed Product-by-Licensed Product and Region-by-Region basis, royalties will be due under this Section 8.4 with respect to a given Licensed Product in a given Region in the Territory during the period commencing upon the First Commercial Sale of such Licensed Product in such Region in the Territory and ending upon the latest of (i) the expiration of the last-to-expire Valid Claim Covering such Licensed Product in such Region in the Territory, (ii) the expiry of the applicable Regulatory Data Exclusivity for such Licensed Product in such Region, and (iii) [*] years have elapsed following First Commercial Sale of such Licensed Product in such Region in the Territory (such latest ending period, the “Royalty Term”).

  (B)Royalty Payments and Reports. 

  (i)BioNova will report to Sutro the date of First Commercial Sale of a Licensed Product within [*] of occurrence in each Region. 

  (ii)[*] following the end of each Calendar Quarter, following the First Commercial Sale of a Licensed Product, BioNova will furnish to Sutro a written report for the Calendar 

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  Quarter showing the Net Sales of Licensed Product sold by BioNova, its Affiliates and its or their Sublicensees in the Territory during such Calendar Quarter and the royalties payable under this Agreement for such Calendar Quarter. Such written report will include the number of Licensed Products sold by BioNova, its Affiliates and its or their Sublicensees in each Region, the gross sales of Licensed Product on a Region-by-Region and Licensed Product-by-Licensed Product basis, an itemized calculation of any deductions taken from such gross sales to arrive at Net Sales for the applicable Calendar Quarter, a calculation of any applicable reductions under Section 8.6, and the calculation of the amount of royalty payment due on such Net Sales. Further, each such royalty report shall indicate gross sales and Net Sales in each Region’s currency, the applicable royalty rate, the royalties payable for each Region in such Region’s currency, the applicable exchange rate to convert from each Region’s currency to U.S. Dollars, and the royalties payable in U.S. Dollars.

  (iii)After the receipt of each royalty report provided by BioNova under Section 8.4(c)(i) above, Sutro will submit to BioNova an invoice for the amount of royalties payable set forth therein. BioNova will pay to Sutro the royalties for each Calendar Quarter within [*] after the receipt of the invoice from Sutro.

  Section I.70.Upstream License Fees. Notwithstanding anything to the contrary hereunder, Sutro will be solely responsible for any and all payments Sutro owes to the Upstream Licensors under any applicable Upstream Licenses and in no event will BioNova, its Affiliates, its or their Sublicensees or contractors be directly liable for any of such payments, except as otherwise expressly set forth in this Agreement. 

  Section I.71.Payment Reductions. The following will only apply if royalties or Sales Milestone Payments are being paid pursuant to Section 8.3 and Section 8.4:

  (B)Blocking Third Party Intellectual Property. In the event either Party becomes aware of intellectual property rights Controlled by a Third Party that such Party considers necessary to Develop, Manufacture or Commercialize such Licensed Product and its related Licensed Compound in the Field in the Territory (“Third Party Blocking IP”), such Party will notify the other Party, and Sutro will have the first right to obtain a license to such Third Party Blocking IP from such Third Party. In the event Sutro or any of its Affiliates obtains a license to such Third Party Blocking IP such that it Controls such Third Party Blocking IP, such Third Party Blocking IP will be automatically included in the Licensed Know-How and Licensed Patents, as applicable, and subject to Section 8.6(b), Sutro will be the Party providing payments and other consideration payable to such Third Party in respect of such Third Party Blocking IP arising from BioNova, its Affiliates or its or their Sublicensees use of such Third Party Blocking IP in the Development, Manufacture, and Commercialization of the Licensed Compound and Licensed Products in the Field in the Territory under this Agreement. In the event Sutro does not obtain a license to such Third Party Blocking IP such that it Controls such Third Party Blocking IP within [*] of the date of the foregoing notice, BioNova will have the right to obtain a license to such Third Party Blocking IP from such Third Party, and BioNova may deduct from its royalties to Sutro with respect to a Licensed Product any payments made to such Third Party for a license to such Third Party Blocking IP. BioNova will provide Sutro with reasonable prior written notice before entering into an agreement with such Third Party in respect of such a license, and will provide a copy of such Third Party agreement to Sutro within 

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  [*] after its execution, provided that, BioNova may redact from such agreement any sensitive information not necessary to determine the royalty deduction in this Section 8.6(a). 

  (C)Royalty Reductions. If Sutro obtained the license to the Third Party Blocking IP in the above Section 8.6(a), then BioNova will pay the applicable royalty under Section 8.4 to Sutro and Sutro will be (i) [*], (ii) [*], and (iii) [*]

  (D)Generic Entry. At any time during the Royalty Term, after a Biosimilar Product of a Licensed Product receives Marketing Authorization in any Region in the Territory and has launched, BioNova’s royalty for such Licensed Product in such Region under Section 8.4 for any Calendar Quarter will be calculated by multiplying Net Sales of such Licensed Product during such Calendar Quarter by the applicable royalty rate after applying the royalty rate reduction equal to BioNova’s Gross Profit decline for that Calendar Quarter when compared to the average quarterly Gross Profit of such Licensed Product in the [*] immediately prior to the entry of such Biosimilar Product. For clarity, [*]. 

  Section I.72.Financial Audits. 

  (E)Record Keeping. BioNova and its Affiliates will, and will cause its or their respective Sublicensees to, keep complete, true and accurate books and records in accordance with its Accounting Standards of the items underlying (i) Net Sales and Gross Profits, and (ii) royalty payments under this Agreement. BioNova and its Affiliates will, and will cause its or their respective Sublicensees to keep, such books and records for at least [*] following the Calendar Quarter to which they pertain. Sutro will have the right no more than once per Calendar Year, at its own expense, to have an internationally-recognized independent, certified public accountant, selected by Sutro and reasonably acceptable to BioNova (the “Auditor”), review any such records of BioNova in the location(s) where such records are customarily maintained by BioNova upon reasonable prior notice, during regular business hours and under obligations of confidentiality, except to the extent necessary to enforce Sutro’s rights under this Agreement or if disclosure is required by applicable Law, for the sole purpose of verifying the basis and accuracy of payments made under this Agreement and the content of the reports described in Section 8.4(c), within the prior [*] period after receipt of such report. The Auditor will have the right to disclose to Sutro its conclusions regarding any payment owed under this Agreement. The records covering any specific period of time may be audited no more than once except where an audit has found a discrepancy in which case no such restriction will apply.

  (F)Audit Report. The report prepared by the Auditor, a copy of which will be sent or otherwise provided to each Party by such Auditor at the same time before such report is considered final, will contain the conclusions of such Auditor regarding the audit and will specify that the amounts paid pursuant thereto were correct or, if incorrect, the amount of any underpayment or overpayment, and the specific details regarding any discrepancies. No other information will be provided to Sutro without the prior consent of BioNova unless disclosure is required by Laws, regulation or judicial order. If such report shows any underpayment, then BioNova will remit to Sutro, within [*] after receipt of such report, (i) the amount of such underpayment and (ii) if such underpayment [*] of the total amount owed for the period then being audited, the actual costs incurred by Sutro in conducting such review. For the avoidance of doubt, payment of the underpayment will be considered a late payment, subject to Section 8.10. If such report shows any overpayment, then BioNova will credit the overpaid amount against future payments 

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  owed to Sutro. The Parties mutually agree that all information subject to review under this Section 8.7 is Confidential Information of both Parties and that the receiving Party will retain and cause the Auditor to retain all such information in confidence in accordance with confidentiality and non-use obligations no less stringent than those contained in ARTICLE X.

  Section I.73.Tax Withholding. Each Party will be responsible for its own taxes. In the event any withholding or other tax based on income to Sutro (“Tax Withholdings”) is required to be withheld and deducted from payments by BioNova (or its Affiliate paying on behalf of BioNova) pursuant to this Agreement under applicable Laws, BioNova (or its Affiliate paying on behalf of BioNova) will make such deduction and withholding and will pay the remainder to Sutro, and any amounts so withheld and deducted will be remitted by BioNova (or its Affiliate paying on behalf of BioNova) on a timely basis to the appropriate Governmental Authority for the account of Sutro and BioNova (or its Affiliate paying on behalf of BioNova) will provide Sutro reasonable evidence of the remittance within [*] thereof. For the purposes of this Agreement, with respect to amounts so deducted and withheld and remitted to the appropriate Governmental Authority, BioNova will be deemed to have fulfilled all of its payment obligations to Sutro with respect to such payments paid to the such Governmental Authority. Notwithstanding anything in the foregoing to the contrary, to the extent that the amount of any deduction or withholding for Taxes is increased as a result of the assignment or assumption of any of BioNova’s rights or obligations hereunder to or by a Person outside of the Territory for tax purposes, BioNova shall increase amount of its payments hereunder so that Sutro receives the same amount (after such taxes) as it would have received if such assignment or assumption had not occurred. BioNova may satisfy its withholding, value added or other tax obligations under this Section 8.8 through its Affiliates. Further, BioNova agrees to use good faith efforts to arrange its business activities and to cooperate and assist Sutro so as to minimize impact of tax withholdings. 

  Section I.74.Currency of Payments. All amounts payable and calculations under this Agreement will be in Dollars. As applicable, Net Sales and any royalty reductions will be translated into Dollars using the average of the applicable daily foreign exchange rates published in The Wall Street Journal (or any other qualified source that is acceptable to both Parties) for the last day of each month of the Calendar Quarter in which such Net Sales occurred. All payments under this Agreement will be paid in Dollars by wire transfer to an account designated by the receiving Party (which account the receiving Party may update from time to time in writing).

  Section I.75.Late Payments. Without limiting any other rights or remedies available to Sutro hereunder, any late payment by BioNova will bear interest, to the extent permitted by Laws, at an annual rate of the prime rate set by The Wall Street Journal (but in no event in excess of the maximum rate permissible under applicable Law) on the date payment was initially due, computed from the dated such payment was due until the date BioNova makes the payment. Notwithstanding the foregoing, no such interest will be assessed if the late payments are due to a change in applicable Law or action or inaction of a Governmental Authority related to Regulatory Approvals or foreign currency, which change was not reasonably foreseeable; provided that, BioNova will use Commercially Reasonable Efforts to remit any such payments to Sutro as promptly as possible.

  Section I.76.Blocked Currency. If, by applicable Laws in a Region in the Territory, conversion into Dollars or transfer of funds of a convertible currency to the United States becomes materially 

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  restricted, forbidden or substantially delayed, then BioNova will promptly notify Sutro and, thereafter, amounts accrued in such country or region under this Section 8.11 will be paid to Sutro (or its designee) in such country or region in local currency by deposit to an escrow account in a local bank designated by Sutro and to the credit of Sutro, unless the Parties otherwise agree. Any amounts paid by deposit to such escrow account in accordance under this Section 8.11 will be deemed paid as of the date of deposit to such escrow account for purposes of Section 8.10.

  Section I.77.Invoices. Any invoice to be submitted to BioNova by Sutro hereunder may be submitted by email or other similar form of electronic communication and need not conform to any particular format provided that such invoice satisfies Sutro’s Accounting Standards, except where required by applicable Laws or the banks of BioNova or BioNova’s Affiliates to convert local currency to Dollars or to make payments in Dollars directly to Sutro, in which case, Sutro will provide to BioNova such invoice in the form and with information consistent with the pro forma invoice provided to Sutro by BioNova, an example of which is attached hereto as Exhibit F.

  ARTICLE IX
INTELLECTUAL PROPERTY OWNERSHIP, 
PROTECTION AND RELATED MATTERS

  Section I.78.Ownership of Inventions.

  (C)Background Technology. As between the Parties, subject to Section 9.1(b), Sutro will remain the sole and exclusive owner of all Licensed Technology and BioNova will remain the sole and exclusive owner of all Know-How, Patent Rights, and other intellectual property rights Controlled by BioNova or its Affiliates as of the Effective Date or during the Term.

  (D)Ownership of Inventions. Ownership of all Inventions will be determined based on inventorship, as determined in accordance with the rules of inventorship under United States patent Laws. Each Party will own all Inventions that are made solely by its and its Affiliates’ employees, agents, and independent contractors during the performance of activities under this Agreement (“Sole Inventions”); provided that for clarity, Sole Inventions Controlled by Sutro or any of its Affiliates will be included in the Licensed Technology and included in the licenses and rights granted to BioNova by Sutro hereunder and provided that for clarity, Sole Inventions Controlled by BioNova or any of its Affiliates or its or their Sublicensees will be deemed included within BioNova Technology and included in the licenses and rights granted to Sutro by BioNova hereunder including under Section 3.5. The Parties will jointly own all Inventions that are made jointly by the employees, agents, and independent contractors of one Party and its Affiliates together with the employees, agents, and independent contractors of the other Party and its Affiliates (“Joint Inventions”). Patents claiming the Joint Inventions will be referred to as “Joint Patents.” Each Party will own an undivided half interest in the Joint Inventions, without a duty of accounting or an obligation to seek consent from the other Party for the transfer, assignment, exploitation or license of the Joint Inventions (subject to the licenses granted to the other Party under this Agreement). 

  (A)Assignment Obligation. Each Party will assign its rights, and cause all employees of such Party who perform activities for such Party under this Agreement to be under an obligation to assign their rights, in any Patent Rights and Know-How resulting therefrom to such Party to effectuate the 

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  terms and conditions set forth in Section 9.1(b). Subject to Section 3.2(c)(ii), with respect to any activities of BioNova or exercise of its rights under this Agreement that are subcontracted to a Person that is not an employee, BioNova will include in the applicable subcontract an assignment to BioNova of all rights in Patent Rights and Know-How related to the Licensed Compound or Licensed Product made by such subcontractor resulting from such activities or exercise of its rights, and in any event where such assignment is precluded, will include in the applicable subcontract a license of such Patent Rights and Know-How to BioNova that is sublicensable (through multiple tiers) to Sutro under this Agreement.

  (B)Disclosure of Inventions. Each Party will promptly disclose to the other Party all Inventions related to the Licensed Compound or Licensed Product, including all invention disclosure or other similar documents submitted to such Party by its or its Affiliates’ employees, agents, or independent contractors relating to such Inventions, and will also promptly respond to reasonable requests from the other Party for additional information relating to such Inventions.

  Section I.79.Prosecution and Maintenance of the Licensed Patents and Joint Patents.

  (C)Licensed Patents. As between the Parties, Sutro will have the first right, at its expense, to prepare, file, prosecute, maintain, and defend the Licensed Patents in the Field in all Regions in the Territory, at Sutro’s sole cost and expense. Sutro will keep BioNova reasonably informed of all steps with regard to and the status of such preparation, filing, prosecution, maintenance, and defense of such Patent Rights, including by providing BioNova with (i) copies of all correspondence and material communications it sends to or receives from any patent office or agency in the Territory relating to such Patents Rights, (ii) a draft copy of all applications sufficiently in advance of filing to permit reasonable review and comment by BioNova and giving due consideration to such comments, and (iii) a copy of applications as filed, together with notice of its filing date and serial number. Before Sutro submits any material filing, including a new patent application, or response to such patent authorities with respect to any Licensed Patents, Sutro will provide BioNova with a reasonable opportunity to review and comment on such filing or response and will take into account and consider in good faith BioNova’s reasonable and timely requests and suggestions regarding the preparation, filing, prosecution, maintenance, and defense of such Licensed Patents under this Section 9.2(a). 

  (D)Joint Patents. BioNova will have the first right to prepare, file, prosecute, maintain and defend Joint Patents in the Territory, at BioNova’s sole cost and expense. Sutro will have the first right to prepare, file, prosecute, maintain and defend the Joint Patents outside the Territory, at Sutro’s sole cost and expense. Each Party will keep the other Party reasonably informed of the status of all actions taken, and will consider in good faith the other Party’s recommendations and proposals for coordinating the prosecution efforts to optimize protections for both Parties.

  (E)Step-In Right. If the Party having the first right in Section 9.2(a) or Section 9.2(b) elects not to prepare, file, prosecute, continue to prosecute or maintain a given Patent Right within the Licensed Patents, Patent Rights in Sole Inventions or Joint Patents (“Abandoning Party”), then the Abandoning Party will give the other Party notice thereof within a reasonable period (but not less than [*] prior to allowing such Patent Rights to lapse or become abandoned or unenforceable, and the other Party will have the right to prepare, file, prosecute, maintain or defend such Patent Right. The other Party will have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution, or 

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  continuation of the prosecution of such Patent Rights in such region and paying any required fees to maintain such Patent Rights in such region or defending such Patent Rights, all at such other Party’s sole expense, through patent counsel or agents of its choice. A Party will not become an assignee of any such Patent Rights as a result of its assumption of any such responsibility, except as expressly provided herein. Upon transfer of the Abandoning Party’s responsibility for preparing, filing, prosecuting, maintaining or defending any of the Patent Rights to the other Party under this Section 9.2(c), the Abandoning Party will promptly deliver to the other Party copies of all necessary files related to the Patent Rights with respect to which responsibility has been transferred and will take all actions and execute all documents reasonably necessary for the other Party to assume such prosecution, maintenance and defense. In the event BioNova assumes the preparation, filing, prosecution, maintenance, and defense of any Licensed Patent, such Patent Right will no longer be considered a Licensed Patent for purposes of determining the Royalty Term pursuant to Section 8.4(b). In the event Sutro assumes the preparation, filing, prosecution, maintenance, and defense of any patent application or patent in respect of a BioNova Sole Invention (which for clarity BioNova has itself elected to protect and had then filed a patent application to seek to protect), at Sutro’s option, BioNova agrees to assign, and does hereby assign, to Sutro its entire right, title and interest in and to such Patent Right and thereafter, BioNova shall have a royalty-free, non-exclusive, non-transferrable and non-sublicensable license under such Patent Right for its internal research purposes. 

  (F)Cooperation. Each Party will, and will cause its Affiliates to, reasonably cooperate, with the other Party with respect to the preparation, filing, prosecution and maintenance of Licensed Patents and Joint Patents pursuant to this Section 9.2, including with respect to obtaining patent term restoration, supplemental protection certificates or their equivalents, and patent term extensions with respect to the Licensed Patents and Joint Patents in any Region where applicable.

  Section I.80.Third Party Infringement. 

  (G)Notice. Each Party will promptly notify the other in writing of any (i) apparent, threatened or actual infringement by a Third Party of any Licensed Patent, Patent Right in a Sole Invention or Joint Patent, or (ii) unauthorized use or misappropriation of any Licensed Know-How by a Third Party of which it becomes aware, and, in each case, will provide the other Party with all evidence in such Party’s possession or control supporting such infringement or unauthorized use or misappropriation (each, an “Infringement”). 

  (H)BioNova First Right. As between the Parties, BioNova will have the first right, but not the obligation, using counsel of its choosing and at its sole expense, to institute any Action alleging Infringement of the Licensed Patents or Joint Patents (any such Action, an “Infringement Action”) in the Territory. Sutro will have the right, at its own expense, to be represented in any such Infringement Action by counsel of its own choice. BioNova will notify Sutro of its decision to commence an Infringement Action and will keep Sutro apprised in writing of any such Infringement Action and will consider Sutro’s reasonable interests and requests regarding such Infringement Action.

  (I)Step-in Right. If BioNova fails to commence a suit to enforce the Licensed Patents or Joint Patents against such Infringement Action (or to settle or otherwise secure the abatement of such Infringement Action) within (i) [*] after its receipt or delivery of notice under Section 9.3(a), or (ii) [*] before the time limit, if any, set forth in applicable Laws for the filing of such actions, whichever comes 

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  first, or ceases to diligently pursue such Infringement Action, Sutro will have the right, but not the obligation, at its own expense to institute such Infringement Action against the applicable Third Party infringer(s). 

  (J)Cooperation. In any Infringement Action brought under the Licensed Patents or Joint Patents pursuant to Section 9.3(b) and Section 9.3(c), each Party will, and will cause its Affiliates to, reasonably cooperate with each other, in good faith, relative to the other Party’s efforts to protect the Licensed Patents and Joint Patents, and will join such suit as a party, if requested by the other Party. Furthermore, the Party initiating any Infringement Action pursuant to Section 9.3(b) or Section 9.3(c) will consider in good faith all reasonable and timely comments from the other Party on any proposed arguments asserted or to be asserted in litigation related to the enforcement or defense of any such Patent Rights. Neither Party will have the right to settle any patent infringement litigation with respect to any Licensed Patent or Joint Patents under this Section 9.3 in a manner that diminishes the rights or interests of the other Party without the consent of such other Party (which will not be unreasonably withheld).

  (K)Allocation of Recoveries. Any settlements, damages or monetary awards recovered by either Party pursuant to any Infringement Action with respect to the Licensed Patents or Joint Patents in the Territory will, after reimbursing the Parties for their reasonable out-of-pocket expenses in making such recovery (which amounts will be allocated pro rata if insufficient to cover the totality of such expenses), [*]

  Section I.81.Claimed Infringement. Each Party will promptly notify the other Party if a Third Party brings any Action alleging patent infringement by BioNova or Sutro or any of their respective Affiliates or its or their Sublicensees with respect to the Development, Manufacture or Commercialization of any Licensed Product or Joint Patents (any such Action, an “Infringement Claim”) in the Field in the Territory. BioNova will have the right, but not the obligation, to control the defense and response to any such Infringement Claim in the Field and in the Territory with respect to BioNova’s activities, at BioNova’s sole cost and expense, and Sutro will have the right, at its own expense, to be represented in any such Infringement Claim in the Field and in the Territory by counsel of its own selection. Sutro will have the sole right, but not the obligation, to control the defense and response to any such Infringement Claim with respect to Sutro’s activities, including any such Infringement Claim in the Territory or outside of the Territory. Upon the request of the Party controlling the response to the Infringement Claim, the other Party will reasonably cooperate with the controlling Party in the reasonable defense of such Infringement Claim. The other Party will have the right to consult with the controlling Party concerning any Infringement Claim and to participate in and be represented by independent counsel in any associated litigation. If the Infringement Claim is brought against both Parties, then each Party will have the right to defend against the Infringement Claim. The Party defending an Infringement Claim under this Section 9.4 will (a) consult with the other Party as to the strategy for the prosecution of such defense, (b) consider in good faith any comments from the other Party with respect thereto, and (c) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such defense. The Party controlling the defense against an Infringement Claim will have the right to settle such Infringement Claim on terms deemed reasonably appropriate by such Party; provided, that, unless any such settlement includes a full and unconditional release from all liability of the other Party and does not adversely affect the rights of the other Party, any such settlement will be subject to the other Party’s prior written consent (not to be unreasonably withheld). 

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  Section I.82.Common Interest. All information exchanged between the Parties regarding the preparation, filing, prosecution, maintenance, defense, and enforcement of Licensed Patents and Joint Patents under this ARTICLE IX will be deemed Confidential Information of the disclosing Party. In addition, the Parties acknowledge and agree that, with regard to such activities, the interests of the Parties as collaborators and licensor and licensee are to obtain the strongest patent protection possible, and as such, are aligned and are legal in nature. The Parties agree and acknowledge that they have not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning the Patent Rights under this ARTICLE IX, including privilege under the common interest doctrine and similar or related doctrines. Notwithstanding anything to the contrary contained herein, to the extent a Party has a good faith belief that any information required to be disclosed by such Party to the other Party under this ARTICLE IX is protected by attorney-client privilege or any other applicable legal privilege or immunity, such Party will not be required to disclose such information, and the Parties will in good faith cooperate to agree upon a procedure (including entering into a specific common interest agreement, disclosing such information on a “for counsel eyes only” basis or similar procedure) under which such information may be disclosed without waiving or breaching such privilege or immunity.

  ARTICLE X
CONFIDENTIALITY AND PUBLICITY

  Section I.83.Confidential Information. 

  (A)Confidentiality Obligation. During the Term and for a period of [*] thereafter, each Party agrees to, and will cause its Affiliates and its or their Sublicensees and contractors to, keep in confidence and not to disclose to any Third Party, or use for any purpose, except to exercise its rights or perform its obligations under this Agreement, any Confidential Information of the other Party, without the prior written consent of such disclosing Party. The existence and terms of this Agreement are the Confidential Information of each Party. 

  (B)Permitted Disclosures. Each Party agrees that it and its Affiliates will provide or permit access to the other Party’s Confidential Information only to the receiving Party’s employees, consultants, advisors, licensees and Sublicensees, and to the employees, consultants and advisors of the receiving Party’s Affiliates, in each case on a need-to-know basis who are subject to obligations of confidentiality and non-use with respect to such Confidential Information no less stringent than the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 10.1; provided, however, that each Party will remain responsible for any failure by its Affiliates, licensees or Sublicensees, and its and its Affiliates’ respective employees, consultants and advisors, to treat such Confidential Information as required under this Section 10.1 as if such Affiliates, employees, consultants, advisors, licensees and Sublicensees were parties directly bound to the requirements of this Section 10.1.

  (C)Confidentiality Limitation. Notwithstanding anything to the contrary herein, each Party may use and disclose the other Party’s Confidential Information as follows: (i) under appropriate written confidentiality and non-use obligations no less stringent than those in this Agreement, to its Affiliates, bona fide potential or actual collaborators, licensors, Sublicensees, licensees, or strategic partners and to employees, directors, agents, consultants, and advisers of any other Third Parties, (ii) to its financial advisors, attorneys and accountants, bona fide actual or potential acquisition partners, financing 

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  sources or investors and underwriters on a need-to-know basis, in each case under appropriate confidentiality and non-use obligations (which may include professional ethical obligations) no less stringent than those in this Agreement; provided, however, that each Party may disclose the terms of this Agreement (but not any other Confidential Information) to bona fide actual or potential acquisition partners, financing sources or investors on a need to know basis, in each case under appropriate confidentiality and non-use obligations (which may include professional ethical obligations) no less stringent than those in this Agreement and of duration customary in confidentiality agreements entered into for a similar purpose; provided, further, that each Party will remain responsible for any failure by any of the foregoing individuals to treat such Confidential Information as required under Section 10.1 as if such individuals were parties directly bound to the requirements of this Section 10.1, or (iii) as required by any court or other governmental body or as otherwise required by applicable Laws (including any such disclosures as are required by a Regulatory Authority in connection with making any Regulatory Filing or seeking Regulatory Approval, Pricing and Reimbursement Approval, import authorization for any Licensed Product in the Territory, or the rules or regulations of the United States Securities and Exchange Commission or similar Regulatory Authority in a country other than the United States or of any stock exchange or listing entity (including in connection with the public sale of securities)); provided, that, notice is promptly given to the other Party and the disclosing Party cooperates with reasonable requests from the other Party to seek a protective order or other appropriate remedy to protect the Confidential Information. Notwithstanding anything to the contrary contained in this ARTICLE X, Confidential Information that is permitted or required to be disclosed will remain otherwise subject to the confidentiality and non-use provisions of Section 10.1(b) and this Section 10.1(c). If either Party concludes that a copy of this Agreement must be filed with the United States Securities and Exchange Commission or similar Regulatory Authority in a country other than the United States, then such Party will, within a reasonable time prior to any such filing, provide the other Party with a copy of such agreement showing any provisions hereof as to which the Party proposes to request confidential treatment, will provide the other Party with an opportunity to comment on any such proposed redactions and to suggest additional redactions, and will take such Party’s reasonable comments into consideration before filing such agreement and use Commercially Reasonable Efforts to have terms identified by such other Party afforded confidential treatment by the applicable Regulatory Authority.

  Section I.84.Publicity. The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding the Licensed Product in the Field in the Territory, and each Party may make such disclosures from time to time, subject to the terms and conditions of this Agreement, including this Section 10.2. Such disclosures may include achievement of milestones, significant events in the Development process with respect to Licensed Products, or Commercialization activities with respect to Licensed Products. 

  (D)On a date to be mutually agreed by the Parties, the Parties will jointly issue a press release regarding the signing of this Agreement. Except as set forth in the preceding sentence and for disclosures permitted in accordance with Section 10.1(b), whenever either Party elects to make any public disclosure regarding milestones, significant events in the Development or Commercialization of the Licensed Products in the Field in the Territory, it will first notify the other Party of such planned press release or public announcement and provide a draft for review no less than [*] in advance of issuing such press release or making such public announcement (or, with respect to press releases and public announcements that are required by applicable Laws, with as much advance notice as possible under the 

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  circumstances if it is not possible to provide notice no less than [*]. Each Party will have the right to review and approve any such planned press release or public announcement proposed by the other Party with respect to Licensed Products in the Field in the Territory, or that includes Confidential Information of the other Party; provided, however, that (A) the reviewing Party will attempt to provide such approval as soon as reasonably possible and will not unreasonably withhold such approval; (B) the reviewing Party will provide explanations of its disapproval of such press release; and (C) a Party desiring to make such public disclosure may issue such press release or public announcement without such prior review by the other Party if (1) the contents of such press release or public announcement have previously been made public other than through a breach of this Agreement by such Party, and (2) such press release or public announcement is consistent with the previously issued press release or other publicly available information; and provided, further, that the other Party will have the right to review, but not approve, any press release or public announcement that the proposing Party determines is required by applicable Laws based on the advice of counsel, which public disclosures are subject to Section 10.2. The Party reviewing a press release provided under this Section 10.2(a) will review and approve or disapprove such press release within [*] after its receipt thereof. 

  (E)The principles to be observed in such disclosures will include accuracy, compliance with applicable Laws and regulatory guidance documents, reasonable sensitivity to potential negative reactions of Regulatory Authorities and the need to keep investors informed regarding the business of the Party making such public disclosure. 

  (F)In the event that either Party proposes to publish or present the results of Development or Commercialization carried out on the Licensed Product in the Territory, including any oral presentation or abstract that contain clinical data or pertain to results of Clinical Studies or other studies conducted in the Territory, such publication or presentation will be subject to the prior review by the JSC for patentability and protection of both Parties’ Confidential Information and approval by the other Party (not to be unreasonably withheld). Each Party will provide to the JSC the opportunity to review any proposed abstracts, manuscripts or summaries of presentations that cover the results of Development or Commercialization of Licensed Products in the Territory during the Term. The JSC will review such proposed material at the next meeting of the JSC, and may issue a specific statement of concern, based upon either the need to seek patent protection or concern regarding competitive disadvantage arising from the proposal. In the event that the JSC provides such a statement of concern, the submitting Party will not submit such publication that contains such information until the other Party is given a reasonable period of time to seek patent protection for any material in such publication or presentation that it believes is patentable or to resolve any other issues, and the submitting Party will remove from such proposed publication any Confidential Information of the other Party as requested by the other Party.

  ARTICLE XI
REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS

  Section I.85.Mutual Representations and Warranties. Each Party represents and warrants to the other Party that, as of the Effective Date and, with respect to Sutro, as of the date of the License Option Exercise Notice:

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  (A)Organization. It is a corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement.

  (B)Authority. It has full right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement, it has the right to grant to the other the licenses and sublicenses granted pursuant to this Agreement, and this Agreement and the performance by such Party of this Agreement do not violate such Party’s charter documents, bylaws or other organizational documents.

  (C)Consents. Except for any Marketing Authorizations, Regulatory Approvals, Regulatory Filings, Pricing and Reimbursement Approvals, Manufacturing approvals or similar approvals necessary for the Development, Manufacture or Commercialization of Licensed Products in the Territory, all necessary consents, approvals and authorizations of all Governmental Authorities and other Persons required to be obtained by it in connection with the execution, delivery and performance of this Agreement have been obtained.

  (D)No Conflict. It is not under any obligation, contractual or otherwise, to any Person that would materially affect the diligent and complete fulfillment of obligations under this Agreement and the execution and delivery of this Agreement by such Party, and the performance of such Party’s obligations under this Agreement (as contemplated as of the Effective Date) and the licenses and sublicenses to be granted by such Party pursuant to this Agreement (i) do not conflict with or violate any requirement of Laws applicable to such Party, (ii) do not conflict with or violate any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party, and (iii) do not conflict with, violate, breach or constitute a default under, or give rise to any right of termination, cancellation or acceleration of, any contractual obligations of such Party or any of its Affiliates.

  (E)Enforceability. This Agreement is a legal and valid obligation binding upon it and is enforceable against it in accordance with its terms, subject to the general principles of equity and subject to bankruptcy, insolvency, moratorium, judicial principles affecting the availability of specific performance and other similar Laws affecting the enforcement of creditors’ rights generally.

  (F)Compliance with Laws. The Parties will, and will ensure that their respective Affiliates and Sublicensees will, comply in all material respects with all applicable Laws in exercising their rights and fulfilling their obligations under this Agreement. Without limiting the generality of the foregoing, the Parties will comply with all applicable Laws concerning bribery, money laundering, or corrupt practices or which in any manner prohibit the giving of anything of value to any official, agent, or employee of any government, political party, or public international organization, candidate for public office, health care professional, or to any officer, director, employee, or representative of any other organization specifically including the Anti-Corruption Laws in connection with the activities conducted pursuant to this Agreement. The Parties will require any contractors, subcontractors, Sublicensees, or other Persons that provide services to such Party in connection with this Agreement to comply with such Party’s obligations under this Section 11.1(f).

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  Section I.86.Additional Representations, Warranties and Covenants of Sutro. Sutro represents and warrants as of the Effective Date and as of the date of the License Option Exercise Notice, and covenants to BioNova that:

  (G)Licensed Patents. All Licensed Patents as of the Effective Date are listed in Exhibit C. Except as otherwise noted in Exhibit C, Sutro is the sole and exclusive owner of the Licensed Patents, all of which are free and clear of any claims, liens, charges or encumbrances. With respect to Licensed Patents not solely owned by Sutro, Sutro licenses such Licensed Patents in a manner that permits exclusive sublicenses as provided in this Agreement. All Licensed Patents owned by Sutro and, to Sutro’s knowledge, all other Licensed Patents, have been filed and prosecuted in good faith in the patent offices in accordance with applicable Laws, and all applicable fees have been paid on or before the due date for payment. To Sutro’s knowledge, all issued Licensed Patents are valid and enforceable.

  (H)Licensed Know-How. To its knowledge, Sutro owns or Controls the Licensed Know-How, and has the right to grant the licenses under the Licensed Know-How to BioNova on and the terms set forth in this Agreement. To its knowledge, Sutro has the right to use and disclose (in each case, under appropriate circumstances of confidentiality) the Licensed Know-How free and clear of any claims, liens, charges or encumbrances. 

  (A)Licensed Technology. Sutro has not granted to any Third Party, including any academic organization or agency, any license, option or other rights to research, Develop, Manufacture, use or Commercialize the Licensed Compound or the Licensed Products in the Field in the Territory. No Third Party has any license, option or other rights or interest in or to the Licensed Technology other than the rights that are expressly reserved or contingent under this Agreement. The Licensed Technology constitutes all the Patent Rights and Know-How Controlled by Sutro or any of its Affiliates that are necessary for the Development or Commercialization, but for clarity, and notwithstanding the implication of the foregoing terms “Development” and “Commercialization”, in no way related to Manufacturing, of the Licensed Compound and the Licensed Product in the Field in the Territory without infringing Patent Rights or misappropriating any Know-How Controlled by Sutro or any of its Affiliates. 

  (B)Licensed Marks. All Licensed Marks as of the Effective Date are listed in Exhibit B. 

  (C)Delivery of Documentation. True, accurate and materially complete copies of: (i) all existing material Regulatory Filings in its possession and control relating to Licensed Products, (ii) all material adverse information with respect to the safety and efficacy of the Licensed Products in Sutro’s or its Affiliates’ possession and control, and (iii) all material data in Sutro’s or its Affiliates’ possession and control, in each case ((i), (ii) and (iii)) have been provided or made available to BioNova prior to the Effective Date.

  (D)Third Party Challenges. There are no claims, judgments, or settlements against, or amounts with respect thereto, made or, to Sutro’s knowledge, threatened by any Person against Sutro or any of its Affiliates relating to the Licensed Patents or the Licensed Know-How. No claim or notice of proceeding has been received by Sutro or its Affiliates or, to Sutro’s knowledge, threatened by any Person (i) alleging that the Licensed Patents are invalid or unenforceable, (ii) asserting the misuse of any of the 

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  Licensed Patents, (iii) challenging Sutro’s Control of the Licensed Patents (i.e., alleging that a Third Party has a right or interest in or to the Licensed Technology) or (iv) alleging misappropriation of the Know-How of any Third Party used in the Development, Manufacture or Commercialization of the Licensed Compound or Licensed Products by or on behalf of Sutro prior to the Effective Date.

  (E)Non-Infringement of Third Party IP. To Sutro’s knowledge, the Development, Manufacture or Commercialization of the Licensed Product, as conducted by Sutro, its Affiliates, or its or their Sublicensees prior to the Effective Date did not infringe any Patent Right in the Territory or misappropriate or otherwise violate any Know-How of any Third Party (in the case of pending Patent Rights, evaluating them as if issued). No claim of infringement of the Patent Rights in the Territory or misappropriation of the Know-How of any Third Party has been received by Sutro, or to Sutro’s knowledge, threatened, against Sutro, any of its Affiliates or its or their Sublicensees with respect to the Development, Manufacture or Commercialization of Licensed Products in the Territory. To Sutro’s knowledge, the Development, Manufacture or Commercialization of the Licensed Compound or Licensed Product would not infringe, if Developed, Manufactured or Commercialized as of the date hereof, any Patent Right in the Territory or misappropriate or otherwise violate any Know-How of any Third Party (in the case of pending Patent Rights, evaluating them as if issued).

  (F)Absence of Litigation. There are no judgments or settlements against or owed by Sutro, its Affiliates or its or their Sublicensees, or, to Sutro’s knowledge, pending litigation against Sutro, its Affiliates, or its or their Sublicensees, or litigation threatened against Sutro, its Affiliates, or its or their Sublicensees, in each case related to the Licensed Compound or Licensed Products, including any such litigation any relating to any Regulatory Filings, Regulatory Approvals, Pricing and Reimbursement Approvals, or Marketing Authorizations Controlled by Sutro, its Affiliates or its or their Sublicensees as of the Effective Date.

  (G)Maintenance of Regulatory Filings, Good Laboratory and Clinical Practices. Sutro, its Affiliates, and its or their Sublicensees have generated, prepared, maintained, and retained all Regulatory Filings, Regulatory Approvals, and Marketing Authorizations in its control that are required to be maintained or retained pursuant to and in material compliance with applicable Laws, and have conducted in material compliance with applicable Laws, including GLP and GCP all Development of Licensed Products in the Field conducted prior to the Effective Date except to the extent that any material non-compliance has not had a material adverse effect, and to Sutro’s knowledge of Development and the regulation of pharmaceuticals in the Territory, would not be likely to materially and adversely impact the integrity of the data or the ability of BioNova to use or reference such Regulatory Filings, Regulatory Approvals, and Marketing Authorizations in connection with the Developing, seeking, obtaining, or maintaining Regulatory Approval of, and Commercializing the Licensed Products in the Territory, and to Sutro’s knowledge of Development and the regulation of pharmaceuticals in the Territory, would not be likely to cause and require any studies, tests and pre-clinical and Clinical Studies to be repeated in the Territory, in whole or in part.

  (H)Confidentiality of Know-How. Sutro has taken and will continue during the Term to take precautions, consistent with its usual business practice, to preserve the confidentiality of the Licensed Know-How. 

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  (I)Assignment of Third Party Rights; Third Party Consents. 

  (i)Sutro has obtained from each of its employees and agents, and from the employees and agents of its Affiliates, who are performing Development activities for the Licensed Products, rights to any and all Know-How created by such employees and agents in the course of such activities that relates to Licensed Products, such that BioNova will, by virtue of this Agreement, receive from Sutro, without payments beyond those required by ARTICLE VIII, the licenses and other rights granted to BioNova under this Agreement.

  (i)Each Person who has or has had any ownership rights in or to any Licensed Patents purported to be owned solely by Sutro, has assigned and has executed an agreement assigning its entire right, title, and interest in and to such Licensed Patents to Sutro, and to Sutro’s knowledge, no current officer, employee, agent, or consultant of Sutro or any of its Affiliates is in violation of any term of any assignment or other agreement, in each case, regarding the protection of the Licensed Patents.

  (ii)Prior to the Effective Date, Sutro has all rights and licenses, and has obtained all consents from Third Parties with which it has a contractual relationship necessary to grant BioNova the licenses and rights Sutro purports to grant to BioNova under this Agreement other than consents which may be required pursuant to Sutro’s Loan and Security Agreement dated February 2020 with Oxford Finance and Silicon Valley Bank which consents Sutro agrees to obtain and provide copies thereof to BioNova as soon as practicable after the Effective Date. In the event Sutro fails to obtain such foregoing consents, BioNova will have the right to terminate this Agreement in its entirety by written notice to Sutro and, upon such termination, Sutro will return to BioNova in full the License Option Payment within [*] of its receipt of such written notice of termination from BioNova. 

  (J)Statements to Regulatory Authorities. Neither Sutro nor any of its Affiliates, nor, to Sutro’s knowledge, its or their Sublicensees nor any of its or their respective officers, employees, or agents has made or will make an untrue statement of material fact or fraudulent statement to any Regulatory Authority with respect to the Development or Commercialization of Licensed Products, or failed or will fail to disclose a material fact required under applicable Laws to be disclosed to any Regulatory Authority with respect to the Development or Commercialization of Licensed Products.

  (K)Compliance with Laws. To Sutro’s knowledge, all of the studies, tests and pre-clinical and Clinical Studies of Licensed Products conducted prior to, or being conducted as of, the Effective Date, or that are conducted during the Term by or on behalf of Sutro have been, are being conducted, and will be conducted in all material respects in accordance with applicable Laws.

  (I)No Conflict. During the Term, Sutro and its Affiliates will not grant any interest in the Licensed Technology that is inconsistent with the terms and conditions of this Agreement.

  (J)No Government Funding. The inventions claimed by the Licensed Patents and any other Patent Rights with respect to the Licensed Compound or Licensed Product were not conceived, reduced to practice, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by any grants, funds, or other money received from any Governmental Authority, and no Governmental Authority or academic institution has any right to, ownership of 

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  (including any “step-in” or “march-in” rights with respect to), or right to royalties for, or to impose any restriction on the assignment, transfer, grant of licenses or other disposal of the Licensed Technology, or to impose any requirement or restriction on the use of the Licensed Compound or Licensed Product as contemplated herein, in each case. 

  Section I.87.Additional Representations, Warranties and Covenants of BioNova. BioNova represents and warrants as of the Effective Date and as of the date of the License Option Exercise Notice, and covenants to Sutro that: 

  (K)No Claims. There are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial, or legal, administrative, or other proceedings or governmental investigations pending or, to BioNova’s knowledge, threatened against BioNova or its Affiliates which would reasonably be expected to adversely affect or restrict the ability of BioNova and its Affiliates to consummate and perform the transactions and activities contemplated under this Agreement.

  (L)Maintenance of Regulatory Filings, Good Laboratory and Clinical Practices. BioNova, its Affiliates, and its or their Sublicensees will generate, prepare, maintain, and retain all Regulatory Filings, Regulatory Approvals, and Marketing Authorizations in its Control that are required to be maintained or retained pursuant to and in material compliance with applicable Laws, and will conduct in material compliance with applicable Laws, including GLP and GCP, all Development activities for the Licensed Product in the Territory. 

  (M)Assignment of Rights. BioNova will obtain from each of its employees and agents, and from the employees and agents of its Affiliates, who will be performing Development activities for the Licensed Products, rights to any and all Know-How created by such employees and agents in the course of such activities that relates to Licensed Products, such that Sutro will, by virtue of this Agreement, receive from BioNova, without any payment or other consideration, the licenses and other rights granted to Sutro under this Agreement.

  (N)Compliance with Laws. All of the studies, tests and pre-clinical and Clinical Studies of drug products (other than the Licensed Products) conducted by BioNova prior to, or being conducted as of, the Effective Date, have been conducted, to BioNova’s knowledge, in all material respects in accordance with applicable Laws. All of the studies, tests and pre-clinical and Clinical Studies of Licensed Products to be conducted by BioNova under this Agreement will be conducted in all material respects in accordance with applicable Laws.

  (O)No Conflict. During the Term, BioNova and its Affiliates will not grant any interest in the BioNova Technology that is inconsistent with the terms and conditions of this Agreement and the licenses and rights of Sutro hereunder.

  (P)Expertise and Experience. BioNova has or will acquire the requisite expertise and experience to perform the Development, obtain Regulatory Approval for, and Commercialize the Licensed Products as contemplated by this Agreement.

  Section I.88.No Debarment. Each Party represents and warrants that neither it nor any of its or its Affiliates’ employees or agents performing under this Agreement has ever been, or is currently: (a) 

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  debarred under 21 U.S.C. § 335a or by any Regulatory Authority; (b) excluded, debarred, suspended, or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs; (c) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators; or (d) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. Each Party further covenants that if, during the Term of this Agreement, it becomes aware that it or any of its or its Affiliates’ employees or agents (including any Third Party subcontractor or Sublicensee of BioNova) performing under this Agreement is the subject of any investigation or proceeding that could lead to that Party becoming a debarred entity or individual, an excluded entity or individual or a convicted entity or individual, such Party will promptly notify the other Party.

  Section I.89.Compliance.

  (Q)Each Party covenants that: (a) in the performance of its obligations under this Agreement, such Party shall comply and shall cause its and its Affiliates’ employees and contractors to comply with all applicable Laws, including all export control, and shall not cause such other Party’s indemnitees (as defined in Section 12.1 and Section 12.2) to be in violation of any applicable Laws or otherwise cause any reputational harm to such other Party.

  (R)Each Party covenants that in the performance of its obligations under this Agreement, such Party shall comply and shall cause its and its Affiliates’ employees and contractors to comply with, all Anti-Corruption Laws. Such Party and its and its Affiliates’ employees and contractors shall not, in connection with the performance of their respective obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to any Governmental Authority or representative thereof or other person for the purpose of obtaining or retaining business for or with, or directing business to, any person, including either Party, in any manner that would be in breach of any Anti-Corruption Laws.

  Section I.90.No Other Warranties. EXCEPT AS EXPRESSLY STATED IN Section 11.1, Section 11.2, Section 11.3, OR Section 11.4, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WARRANTIES OF TITLE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY WITH RESPECT TO THE LICENSED COMPOUND, THE LICENSED PRODUCT, VALIDITY, ENFORCEABILITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. 

  ARTICLE XII
INDEMNIFICATION; DAMAGES

  Section I.91.Indemnification by Sutro. Sutro will defend, indemnify and hold harmless BioNova, its Affiliates and their respective directors, officers, employees and agents (each, a “BioNova Indemnified Party”), from, against and in respect of any and all Third Party Losses incurred or suffered by any BioNova Indemnified Party to the extent resulting from: (a) any breach of any representation or 

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  warranty made by Sutro in this Agreement, or any breach by Sutro of any obligation, covenant or agreement in this Agreement; (b) the gross negligence or intentional misconduct of, or violation of Laws by, Sutro or any of its Affiliates, its or their licensees (other than BioNova) or Sublicensees, or contractors, or any of their respective directors, officers, employees and agents, in performing Sutro’s obligations or exercising Sutro’s rights under this Agreement; (c) activities conducted by or on behalf of Sutro, its Affiliates or its or their licensees (other than BioNova) or Sublicensees, or contractors related to the Development, Manufacture or Commercialization of Licensed Products anywhere in the world prior to the Effective Date; and (d) the Development, Manufacture or Commercialization of the Licensed Products by or on behalf of Sutro, any of its Affiliates, or its or their licensees (other than BioNova) or Sublicensees, or contractors (i) outside the Territory, (ii) outside the Field in the Territory, or (iii) in the Territory following any termination of this Agreement; provided, however, that Sutro’s obligations pursuant to this Section 12.1 will not apply to the extent such Third Party Losses result from Third Party Losses for which BioNova has an obligation to indemnify Sutro pursuant to Section 12.2. 

  Section I.92.Indemnification by BioNova. BioNova will defend, indemnify and hold harmless Sutro, its Affiliates, and their respective directors, officers, employees and agents (each, a “Sutro Indemnified Party”) from, against and in respect of any and all Third Party Losses incurred or suffered by any Sutro Indemnified Party to the extent resulting from: (a) any breach of any representation or warranty made by BioNova in this Agreement, or any breach by BioNova of any covenant or agreement in this Agreement, (b) the gross negligence or intentional misconduct of, or violation of Laws by, BioNova, any of its Affiliates, or its or their Sublicensees or contractors, or any of their respective directors, officers, employees and agents, in performing BioNova’s obligations or exercising BioNova’s rights under this Agreement, (c) the Development, Manufacture or Commercialization of the Licensed Product by or on behalf of BioNova, its Affiliates, or its or their Sublicensees (other than Sutro) or contractors, or (d) activities of the Parties conducted under Section 4.6 and any consequence howsoever arising therefrom; provided, however, that (i) BioNova’s obligations pursuant to subsections (a), (b) and (c) of this Section 12.2 will not apply to the extent such Third Party Losses result from Third Party Losses for which Sutro has an obligation to indemnify BioNova pursuant to Section 12.1, and (ii) BioNova’s obligations pursuant to subsection (d) of this Section 12.2 will not apply to the extent such Third Party Losses result from Third Party Losses resulting from the intentional misconduct or gross negligence of any Sutro Indemnified Party.

  Section I.93.Claims for Indemnification. 

  (A)Notice. An Indemnified Party entitled to indemnification under Section 12.1 or Section 12.2 will give prompt written notification to the Indemnifying Party from whom indemnification is sought of the commencement of any Action by a Third Party for which indemnification may be sought (a “Third Party Claim”) or, if earlier, upon the assertion of such Third Party Claim by a Third Party; provided, however, that failure by an Indemnified Party to give notice of a Third Party Claim as provided in this Section 12.3(a) will not relieve the Indemnifying Party of its indemnification obligation under this Agreement, except and only to the extent that such Indemnifying Party is materially prejudiced as a result of such failure to give notice.

  (B)Defense. Within [*] after delivery of a notice of any Third Party Claim in accordance with Section 12.3(a), the Indemnifying Party may, upon written notice thereof to the 

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  Indemnified Party, assume control of the defense of such Third Party Claim with counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not assume control of such defense, the Indemnified Party may control such defense (with counsel reasonably selected by the Indemnified Party and approved by the Indemnifying Party, such approval not to be unreasonably withheld). The Party not controlling such defense may participate therein at its own expense.

  (C)Cooperation. The Party controlling the defense of any Third Party Claim will keep the other Party advised of the status and material developments of such Third Party Claim and the defense thereof and will reasonably consider recommendations made by the other Party with respect thereto. The other Party will reasonably cooperate with the Party controlling such defense and its Affiliates and agents in defense of the Third Party Claim, with all out-of-pocket costs of such cooperation to be borne by the Party controlling such defense.

  (D)Settlement. The Indemnified Party will not agree to any settlement of such Third Party Claim without the prior written consent of the Indemnifying Party, which consent will not be unreasonably withheld. The Indemnifying Party will not, without the prior written consent of the Indemnified Party, which will not be unreasonably withheld (unless such compromise or settlement involves (i) any admission of legal wrongdoing by the Indemnified Party, (ii) any payment by the Indemnified Party that is not indemnified under this Agreement, or (iii) the imposition of any equitable relief against the Indemnified Party (in which case, (i) through (iii), the Indemnified Party may withhold its consent to such settlement in its sole discretion)), agree to any settlement of such Third Party Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party (other than a monetary obligation on the Indemnifying Party).

  (E)Mitigation of Loss. Each Indemnified Party will take and will procure that its Affiliates and its or their Sublicensees take all such reasonable steps and actions as are necessary or as the Indemnifying Party may reasonably require in order to mitigate any Third Party Claims (or potential losses or damages) under this ARTICLE XII. Nothing in this Agreement will or will be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it.

  Section I.94.Insurance. Each Party, at its own expense, will maintain liability insurance (or self-insure) with respect to its activities under this Agreement in an amount consistent with industry standards in each Party’s respective territory. Each Party will provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to the other Party upon request. Without limiting the foregoing, during the Term and thereafter for the period of time required below, each Party will maintain on an ongoing basis comprehensive general liability insurance policies inclusive of Products Liability and/or Clinical Trials insurance which are consistent with normal business practices of prudent companies similarly situated in such Party’s territory. Not later than [*] following receipt of written request from a Party, the other Party will provide to the requesting Party a certificate of insurance evidencing such insurance policies. Each Party will maintain such insurance or self-insurance coverage without interruption during the Term and for a period of [*] thereafter, and, if applicable, will provide certificates or letters evidencing such insurance coverage without interruption as reasonably requested during the period of time for which such coverage must be maintained. Each Party will be provided at least [*] prior written notice of any cancellation or material decrease in the other Party’s insurance coverage limits 

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  described above. Notwithstanding the foregoing, either Party’s failure to maintain adequate insurance will not relieve that Party of its obligations set forth in this Agreement. 

  ARTICLE XIII
LIMITATION OF LIABILITY

  Section I.95.No Consequential or Punitive Damages. EXCEPT AS SET FORTH IN Section 13.2, NEITHER PARTY NOR ANY OF ITS AFFILIATES OR AFFILIATED ENTITIES WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS OR THE PERFORMANCE OF ITS OBLIGATIONS HEREUNDER, INCLUDING ANY LOST PROFITS OR LOST OPPORTUNITY ARISING OUT OF THIS AGREEMENT, IN EACH CASE HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.

  Section I.96.EXCLUSION FROM LIABILITY LIMITATION. THE LIMITATIONS AND DISCLAIMER SET FORTH IN Section 13.1 WILL NOT APPLY TO A CLAIM: (A) FOR FRAUD, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; (B) FOR A BREACH OF ARTICLE X; (C) FOR A BREACH OF Section 3.9; OR (D) FOR INDEMNIFIABLE LOSSES PURSUANT TO Section 12.1 OR Section 12.2, AS APPLICABLE.

  ARTICLE XIV
TERM AND TERMINATION

  Section I.97.Term. Subject to Section 2.5 and Section 2.6, unless terminated earlier in accordance with this ARTICLE XIV, this Agreement will become effective as of the Effective Date and will continue in full force on a Region-by-Region basis until the expiry of the Royalty Term in each Region in the Territory for all Licensed Products (the “Term”). 

  Section I.98.Paid-Up License Upon End of Royalty Term. On a Licensed Product-by-Licensed Product and Region-by-Region basis, upon the expiration of the Royalty Term for a given Licensed Product in a given Region in the Territory, the licenses and rights of reference granted to BioNova pursuant to Section 3.1 and Section 3.4 will become perpetual, irrevocable, exclusive, sublicensable, transferrable, fully paid-up, and royalty free with respect to such Licensed Product in such Region. Upon the expiration of the Royalty Term of the last Licensed Product in the last Region in the Territory, the licenses granted to Sutro pursuant to Section 3.5 will become perpetual and irrevocable in and outside the Territory.

  Section I.99.Early Termination.

  (A)Termination for Material Breach. Upon (i) any material breach of this Agreement by Sutro or (ii) any material breach of this Agreement by BioNova (the Party so allegedly breaching being the “Breaching Party”), the other Party (the “Non-Breaching Party”) will have the right, but not the obligation, to terminate this Agreement in its entirety by [*] written notice to the Breaching Party, and if such breach is curable, such breach has not been cured by the Breaching Party within [*] of such notice. 

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  The notice will, in each case (A) expressly reference this Section 14.3(a), (B) reasonably describe the alleged breach which is the basis of such termination, and (C) clearly state the Non-Breaching Party’s intent to terminate this Agreement if the alleged breach is not cured within the applicable cure period. Notwithstanding the foregoing, (1) if such material breach, by its nature, is curable, but is not reasonably curable within the applicable cure period, then such cure period will be extended if the Breaching Party provides a written plan for curing such breach to the Non-Breaching Party and uses Commercially Reasonable Efforts to cure such breach in accordance with such written plan; and (2) if the Breaching Party disputes (x) whether it has materially breached this Agreement, (y) whether such material breach is reasonably curable within the applicable cure period, or (z) whether it has cured such material breach within the applicable cure period, the dispute will be resolved pursuant to Section 14.4(k), and this Agreement may not be terminated during the pendency of such dispute resolution procedure. The termination will become effective at the end of the notice period unless the Breaching Party cures such breach during such notice period.

  (B)Termination by BioNova for Convenience. BioNova may, 

  (i)during the License Option Period, upon thirty (30) days’ prior written notice to Sutro, terminate this Agreement in its entirety for convenience without cause; and

  (ii)after exercising the License Option, upon ninety (90) days’ prior written notice to Sutro, terminate this Agreement in its entirety or on a Licensed Product-by-Licensed Product or Region-by-Region basis for convenience without cause. 

  (C)Termination for Bankruptcy. This Agreement may be terminated, to the extent permitted by applicable Laws, by either Party upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however, that in the case of any involuntary bankruptcy, reorganization, liquidation or receivership proceeding such right to terminate will only become effective if the Party subject to such proceeding consents to the involuntary bankruptcy or such proceeding is not dismissed within [*] after the filing thereof. 

  (D)Termination for Patent Challenge. If BioNova or its Affiliates or its or their Sublicensees, individually or in association with any other Person, commences a legal action challenging the validity, enforceability or scope of any Patent Rights within the Licensed Technology (a “Patent Challenge”), then Sutro shall be entitled to terminate this Agreement in its entirety by providing written notice to BioNova, which termination shall take effect on the date of such notice; provided that this Section 14.3(d) will not apply to such action that (i) is first made by BioNova or its Affiliates or its or their Sublicensees in defense of a claim of patent infringement brought by Sutro under the applicable Patent Rights or any Patent Challenge, (ii) was brought by an acquirer of BioNova or its Affiliates or its or their Sublicensees prior to the effective date of a Change of Control involving such Person, or (iii) is brought by any non-Affiliate Sublicensee if BioNova or its Affiliate (A) causes such Patent Challenge to be terminated or dismissed (or in the case of ex-parte proceedings, multi-party proceedings, or other Patent Challenges in which the challenging party does not have the power to unilaterally cause the Patent Challenge to be withdrawn, causes such Sublicensee to withdraw as a party from such Patent Challenge and to cease actively assisting any other party to such Patent Challenge), or (B) terminates such 

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  Sublicensee's sublicense to the Patent Rights being challenged by the Sublicensee, in each case, within [*] after Sutro’s notice to BioNova under this Section 14.3(d).

  (E)Termination for Breach of Anti-Bribery Laws. Subject to the provisions of this Section 14.3(e), if a Party (the “Investigating Party”) believes in good faith, based on advice of counsel, that the other party (the “Investigated Party”) is in material breach of the anti-bribery or anti-corruption provisions of Section 11.1(f) or Section 11.5 and that such material breach would reasonably be expected to result in the Investigating Party or any of its Affiliates incurring material Third Party Losses, then the Investigating Party may provide written notice to the Investigated Party specifically referencing such concerns and this Section 14.3(e) (an “ABAC Notice”). Upon receipt of such ABAC Notice, the Investigated Party will immediately and fully cooperate with the Investigating Party and its Affiliates in the investigation of the alleged breach (the “Investigation”), including by providing the Investigating Party and its Affiliates access to (i) any and all employees, agents or representatives of the Investigated Party or its Affiliates that are relevant to the Investigation, and (ii) all documents and other materials requested by the Investigating Party or any of its Affiliates, in each case ((i) and (ii)), to the extent reasonably necessary for the Investigating Party to conduct such Investigation. The Investigating Party and the Investigated Party will use Commercially Reasonable Efforts to conclude such Investigation as promptly as possible, but in no event later than [*] following the Investigated Party’s receipt of the applicable ABAC Notice (or such longer period as the Parties may mutually agree in writing) (the “Investigation Period”). During the Investigation Period, the Investigating Party may also request that the Investigated Party perform reasonable curative actions in respect of such alleged material breach. If by the end of such Investigation Period, the Investigating Party concludes that such material breach would reasonably be expected to result in the Investigating Party incurring material Third Party Losses and such breach has not been cured by the Investigated Party by the end of such Investigation Period, then the Investigating Party may terminate this Agreement with immediate effect upon written notice to the Investigated Party, with respect to the country or region to which such material breach relates. If prior to the end of the Investigation Period the Investigated Party has cured such material breach (subject to the remainder of this Section 14.3(e) with respect to any dispute related thereto), then the Investigated Party shall no longer have the right to terminate this Agreement for such material breach. For purposes of this Section 14.3(e), the Investigated Party will be deemed to have cured such material breach if the Investigated Party has otherwise identified and terminated its relationship with the individual or individuals responsible for such material breach. 

  Section I.100.Effects of Termination. 

  (F)Effects of Termination Generally. Upon termination of this Agreement in its entirety pursuant to Section 14.3, the JSC will cease to exist, the Parties’ rights, licenses and obligations under this Agreement will terminate and neither Party will have any further rights or obligations under this Agreement from and after the effective date of termination, except as set forth in this Section 14.4; provided, however, that, if this Agreement is terminated with respect to a particular Licensed Product or Region only, then such rights and obligations will terminate only to the extent they relate solely to the terminated Licensed Product or Region and the JSC will continue with respect to non-terminated Licensed Products and Regions.

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  (G)License Grant to Sutro. Except in the case BioNova terminates this Agreement pursuant to Section 14.3(a) or Section 14.3(c), in which case, the licenses granted to Sutro under Section 3.5 will terminate upon the effectiveness of such termination, in case of any other termination or expiration of this Agreement, the licenses granted to Sutro under Section 3.5 will continue following the effective date of termination and for clarity only, is hereby confirmed to be perpetual and irrevocable in all cases and eventualities.

  (H)Accrued Obligations. Expiration or termination of this Agreement for any reason will not release either Party from any obligation or liability which, on the effective date of such expiration or termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination.

  (I)Survival. This Section 14.4, the provisions set forth in the following Sections, as well as, to the extent applicable, any other Sections or defined terms referred to in such Sections or Articles or necessary to give them effect, will survive any expiration or termination of this Agreement in its entirety: Section 3.2(f), Section 5.3 (for the [*] period specified therein), Section 9.1, Section 9.2 (with respect to Joint Patents), Section 9.3 (with respect to Joint Patents), Section 9.4 (solely with respect to claimed infringement prior to the date of termination), Section 11.2(k)(iii), Section 11.6, Section 14.2 (only upon the expiration but not earlier termination of this Agreement) and ARTICLE X (for the [*] period specified therein), ARTICLE VIII (with respect to payments payable and Net Sales realized prior to the termination effective date of this Agreement), ARTICLE XII (for Section 12.4, for the [*] period specified therein), ARTICLE XIII, ARTICLE XV and ARTICLE XVI. Furthermore, any other provisions required to interpret the Parties’ rights and obligations under this Agreement, including applicable definitions in ARTICLE I, will survive to the extent required. Except as otherwise expressly provided in this Agreement (including this Section 14.4), any licenses granted under this Agreement, will terminate upon expiration or termination of this Agreement in its entirety or solely with respect to the terminated Region, as the case may be, for any reason. 

  (J)Ongoing Clinical Study. If at the time of such termination, any Clinical Studies for the Licensed Products are being conducted by or on behalf of BioNova, then, at Sutro’s election on a Clinical Study-by-Clinical Study basis: (i) BioNova will, and will cause its Affiliates and its or their Sublicensees to, (A) continue to conduct such Clinical Study for another period of time as determined by Sutro after the effective date of such termination at Sutro’s cost, and (B) after such period, to (y) fully cooperate with Sutro to transfer the conduct of all such Clinical Study to Sutro or its designee or (z) continue to conduct such Clinical Studies, at Sutro’s cost, for so long as necessary to enable such transfer to be completed without interruption of any such Clinical Studies, and (C) Sutro will assume any and all liability and costs for such Clinical Studies after the effective date of such termination, and (ii) BioNova will, and will cause its Affiliates and its or their Sublicensees to, at Sutro’s cost (unless such termination is by Sutro pursuant to Section 14.3(a)), orderly wind down the conduct of any such Clinical Study which is not assumed by Sutro under clause (i).

  (K)Inventory. 

  (i)Sell-Off Period. BioNova will have the right, for a period of [*] following termination of this Agreement in any Region, to sell or otherwise dispose of any Licensed Products in any 

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  terminated Regions, as applicable, on hand at the time of such termination or in the process of Manufacturing (the “Sell-Off Period”).

  (ii)Sutro Buy-Back. Upon expiration of any Sell-Off Period in any Region, Sutro will have the right to purchase all of BioNova’s and its Affiliates’ remaining inventory of Licensed Products held as of the effective date of expiration of such Sell-Off Period at a price equal to (A) BioNova’s actual invoiced cost of such Licensed Product supplied by Sutro; or (B) one hundred and five percent (105%) of BioNova’s actual invoiced cost of such Licensed Product from its CMO or supplier (other than Sutro).

  (L)Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 14.3, as promptly as practicable after Sutro’s written request, BioNova will, to the extent permitted under applicable Laws and not commercially infeasible, and at Sutro’s sole cost and expense (unless the applicable termination giving rise to Sutro’s rights under this Section 14.4(g) was for BioNova’s material breach pursuant to Section 14.3(a), in which case such transfer will be at BioNova’s sole cost and expense), assign and transfer to Sutro all Regulatory Filings, Regulatory Approvals, Pricing and Reimbursement Approvals and Marketing Authorizations for Licensed Products that are held by or owned by BioNova or its Affiliates or its or their Sublicensees as of the effective date of termination, with respect to the terminated Region, as the case may be, and will take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, Regulatory Approvals, Pricing and Reimbursement Approvals and Marketing Authorizations to Sutro. If applicable Laws or relevant Regulatory Authorities prevent or delay the transfer of ownership of any such Regulatory Filing, Regulatory Approvals, Pricing and Reimbursement Approvals and Marketing Authorizations to Sutro or if it is commercially infeasible for BioNova to do so, then BioNova will grant, and hereby does grant, to Sutro, its Affiliates, Sublicensees and licensees (other than BioNova) an exclusive and irrevocable right of access and right of reference to such Regulatory Filing, Regulatory Approvals, Pricing and Reimbursement Approvals and Marketing Authorizations for Licensed Products in the Field in the Territory or the terminated Region, as the case may be, and will reasonably cooperate with Sutro, at Sutro’s expense (unless the applicable termination giving rise to Sutro’s rights under this Section 14.4(g) was for BioNova’s material breach pursuant to Section 14.3(a), in which case such transfer will be at BioNova’s sole cost and expense), to make the benefits of such Regulatory Filings, Regulatory Approvals, Pricing and Reimbursement Approvals and Marketing Authorizations available to Sutro or its designee(s).

  (M)Return of Confidential Information. Within [*] after the effective date of termination (but not expiration) of this Agreement in its entirety, each Party will, and will cause its Affiliates to, (i) destroy all tangible items solely comprising, bearing or containing any Confidential Information of the other Party that are in such first Party’s or its Affiliates’ possession or Control, and provide written certification of such destruction, or (ii) prepare such tangible items of the other Party’s Confidential Information for shipment to such other Party, as such other Party may direct, at the first Party’s expense; provided, however, that, in any event, (A) each Party may retain copies of the Confidential Information of the other Party to the extent necessary to perform its obligations or exercise its rights that survive expiration or termination of this Agreement; and (B) each Party may retain one copy of the Confidential Information of the other Party for its legal archives.

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  (N)Rights in Bankruptcy. The Parties acknowledge that this Agreement constitutes an executory contract under Section 365 of the Code for the license of “intellectual property” as defined under Section 101 of the Code and constitutes a license of “intellectual property” for purposes of any similar laws in any other country. The Parties further acknowledge that BioNova, as licensee of such rights under this Agreement, will retain and may fully exercise all of its protections, rights and elections under the Code, including, but not limited to, Section 365(n) of the Code, and any similar laws in any other country. In the event of the commencement of a bankruptcy proceeding by or against Sutro under the Code and any similar laws in any other country, BioNova will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and the same, if not already in its possession, will be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon its written request therefor, unless Sutro elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under (a) above, following the rejection of this Agreement by or on behalf of Sutro upon written request therefor by BioNova. All rights, powers and remedies of BioNova provided for in this Section 14.4(i) are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, under the Code and any similar laws in any other country).

  (O)Cooperation. Each Party will cause its Affiliates, and its or their licensees or Sublicensees (for Sutro, other than BioNova) and contractors to comply with the obligations in this Section 14.4.

  (P)Trademark(s) in Territory. BioNova shall assign and transfer to Sutro all of its rights, including trademark rights and goodwill, in and to each of the Trademark(s) used in association with the marketing of the Licensed Product in the Territory.

  ARTICLE XV
DISPUTE RESOLUTION

  Section I.101.Dispute Resolution; Escalation. The Parties recognize that disputes as to certain matters arising out of or in connection with this Agreement may arise from time to time. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising out of or in connection with this Agreement in an expedited manner by mutual cooperation. To accomplish this objective, any and all disputes between the Parties arising out of or in connection with this Agreement will first be referred to the JSC for discussion. Should the Parties, following discussion of the matter at a duly called meeting of the JSC, within [*] after the date on which the matter is referred to the JSC for discussion, are still unable to resolve such matter, then either Party may refer such matter to the Senior Officers for resolution and the Senior Officers will attempt to resolve the matter in good faith. If the Senior Officers fail to resolve such matter within [*] after the date on which the matter is referred to the Senior Officers (unless a longer period is agreed to by the Parties), then, either Party may submit the dispute for final resolution by binding arbitration in accordance with Section 15.2.

  Section I.102.Arbitration. Except as set forth in this Section 15.2, any dispute, difference, controversy or claim arising in connection with or related or incidental to, or question occurring under, this Agreement or the subject matter hereof that cannot be resolved pursuant to Section 15.1, will be referred to and finally resolved by arbitration in accordance with this Section 15.2. A Party may submit 

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  such dispute to arbitration at Singapore International Arbitration Centre (“SIAC”) by notifying the other Party, in writing, of such dispute. Within [*] after receipt of such notice, the Parties will each designate in writing an arbitrator to resolve the dispute. Both of the designated arbitrators will elect a third arbitrator; provided, however, that if the designated arbitrators cannot agree on a third arbitrator within [*] after both arbitrators have been designated, the third arbitrator will be selected by the SIAC. The arbitrators will be a lawyer with biotechnology and/or pharmaceutical industry legal experience, and will not be an Affiliate, employee, consultant, officer, director or stockholder of any Party. The arbitration will be conducted in Singapore in accordance with the Arbitration Rules of the Singapore International Arbitration Centre (“SIAC Rules”) for the time being in force, which rules are deemed to be incorporated by reference in this clause, except to the extent such rules are inconsistent with this Section 15.2, in which case this Section 15.2 will control. All arbitration proceedings will be conducted in the English language. The arbitrators will consider grants of equitable relief and orders for specific performance as co-equal remedies along with awards of monetary damages. The arbitrators will have no authority to award punitive damages. The allocation of expenses of the arbitration, including reasonable attorney’s fees, will be determined by the arbitrators, or, in the absence of such determination, each Party will pay its own expenses. The Parties hereby agree that the arbitrators have authority to issue rulings and orders regarding all procedural and evidentiary matters that the arbitrators deem reasonable and necessary with or without petition therefore by the Parties as well as the final ruling and judgment. All rulings by the arbitrators will be final. Notwithstanding any contrary provision of this Agreement, any Party may seek equitable measures of protection in the form of attachment of assets or injunctive relief (including specific performance and injunctive relief) in any matter relating to the proprietary rights and interests of either Party from any court of competent jurisdiction, pending a decision by the arbitral tribunal in accordance with this Section 15.2. The Parties hereby exclude any right of appeal to any court on the merits of such matter. The provisions of this Section 15.2 may be enforced and judgment on the award (including equitable remedies) granted in any arbitration hereunder may be entered in any court having jurisdiction over the award or any of the Parties or any of their respective assets. Except to the extent necessary to confirm an award or as may be required by Laws, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. The Parties agree that, in the event of a dispute over the nature or quality of performance under this Agreement or a matter under Section 14.3(e), neither Party may terminate this Agreement until final resolution of the dispute through arbitration or other judicial determination. Nothing in this Section 15.2 will preclude either Party from seeking interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. Notwithstanding the Parties’ agreement to arbitrate, unless the Parties agree in writing in any particular case, claims and disputes between the Parties relating to or arising out of, or for which resolution depends in whole or in part on a determination of the interpretation, scope, validity, enforceability or infringement of, Patent Rights or of any Trademark rights relating to any Licensed Products, or misappropriation of any Know-How, will not be subject to arbitration under this Agreement, and the Parties may pursue whatever rights and remedies may be available to them under law or equity, including litigation in a court of competent jurisdiction, with respect to such claims and disputes.

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  Section I.103.Jury Waiver. EACH PARTY, TO THE EXTENT PERMITTED BY LAW, KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ITS RIGHT TO A TRIAL BY JURY IN ANY ACTION OR OTHER LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE TRANSACTIONS IT CONTEMPLATES TO ARBITRATE AS SET FORTH IN Section 15.2. THIS WAIVER APPLIES TO ANY ACTION OR LEGAL PROCEEDING, WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE.

  ARTICLE XVI
MISCELLANEOUS

  Section I.104.Assignment; Successors. 

  (A)Assignment. This Agreement and the rights and obligations of each Party under this Agreement will not be assignable, delegable, transferable, pledged or otherwise disposed of by either Party without the prior written consent of the other Party; provided, however, that either Party may assign or transfer this Agreement together with all of its rights and obligations hereunder, without such consent (but with written notice to the other Party), (i) to an Affiliate or (ii) to a successor in interest in connection with the transfer or sale of all or substantially all of its business or assets to which this Agreement relates, or in the event of its merger or consolidation, reorganization or similar transaction, subject to the assignee agreeing in writing to be bound by the terms and conditions of this Agreement. Any assignment in violation of this Section 16.1(a) will be null and void. 

  (B)Successors. Any permitted assignment of the rights and obligations of a Party under this Agreement will be binding on, and inure to the benefit of and be enforceable by and against, the successors and permitted assigns of the assigning Party. The permitted assignee or transferee will assume all obligations of its assignor or transferor under this Agreement. Any assignment or attempted assignment by either Party in violation of the terms of this Section 16.1(b) will be null, void and of no legal effect.

  Section I.105.Choice of Laws. This Agreement will be governed by and interpreted under the Laws of the State of New York, without regard to the conflicts of law principles thereof. Any dispute, controversy, claim or difference of any kind whatsoever arising out of or in connection with this Agreement will be resolved exclusively in accordance with Section 15.2; provided, however, that all questions concerning (a) inventorship of Patent Rights under this Agreement will be determined in accordance with Section 9.1 and (b) the construction or effect of Patent Rights will be determined in accordance with the Laws of the country, Region or other jurisdiction in which the particular patent within such Patent Rights has been filed or granted, as the case may be. Any communication or proceedings resulting from disputes under this Agreement will be in the English language. The Parties agree to exclude the application to this Agreement of the United Nations Conventions on Contracts for the International Sale of Goods (1980).

  Section I.106.Notices. Any notice or report required or permitted to be given or made under this Agreement by one Party to the other will be in writing and will be deemed to have been delivered (a) upon personal delivery (upon written confirmation of receipt), (b) when received by the addressee, if sent by a reputable internationally recognized overnight courier that maintains records of delivery, or 

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  registered or certified mail, postage prepaid, return receipt requested, provided in each case (a) and (b), the Party giving the notice accompanies such notice by an email of the same content to the other Party. This Section 16.3 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.

  		
	If to Sutro:
	SUTRO Biopharma, Inc.
111 Oyster Point Boulevard
South San Francisco, CA 94080
Attention: General Counsel
Email: [*] 

	 
	 

	 
	 

	If to BioNova:
	BioNova Pharmaceuticals Ltd.
2889 Jinke Road, Chamime Plaza 
Building B, 9F, Suite 905
Shanghai 201203, China
Attention: Chief Executive Officer
Email: [*]

	 
	 

  Section I.107.Severability. In the event that one or more provisions of this Agreement is held invalid, illegal or unenforceable in any respect, then such provision will not render any other provision of this Agreement invalid or unenforceable, and all other provisions will remain in full force and effect and will be enforceable, unless the provisions that have been found to be invalid or unenforceable will substantially affect the remaining rights or obligations granted or undertaken by either Party. The Parties agree to attempt to substitute for any invalid or unenforceable provision a provision which achieves to the greatest extent possible the economic objectives of the invalid or unenforceable provision.

  Section I.108.Integration. This Agreement, together with all schedules and exhibits attached hereto, constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement and supersedes all previous arrangements between the Parties with respect to the subject matter hereof, whether written or oral, including, effective as of the Effective Date, the Confidentiality Agreement; provided that all information disclosed or exchanged under such agreement will be treated as Confidential Information hereunder. In the event of a conflict between a Development Plan or any schedules or attachments to this Agreement, on the one hand, and this Agreement, on the other hand, the terms of this Agreement will govern. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. 

  Section I.109.Waivers and Amendments. The failure of any Party to assert a right under this Agreement or to insist upon compliance with any term or condition of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. The exercise by any Party of any right or election under the terms or covenants herein will not preclude or prejudice any Party from exercising the same or any other right it may have under this Agreement, irrespective of any previous action or proceeding taken by the Parties hereunder. Notwithstanding any authority granted to the JSC under this Agreement, (a) no waiver will be effective unless it has been given in writing and signed by the Party giving such waiver, and (b) no provision of 

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  this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

  Section I.110.Independent Contractors; No Agency. Neither Party will have any responsibility for the hiring, firing or compensation of the other Party’s or such other Party’s Affiliates’ employees or for any employee benefits with respect thereto. No employee or representative of a Party or its Affiliates will have any authority to bind or obligate the other Party for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on such other Party, without such other Party’s written approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, each Party’s legal relationship under this Agreement to the other Party will be that of independent contractor, and the relationship between the two Parties will not constitute a partnership, joint venture, or agency, including for all tax purposes, except as otherwise required by applicable Law.

  Section I.111.Affiliates, Sublicensees, and Contractors. To the extent that this Agreement imposes obligations on Affiliates, Sublicensees or contractors of a Party, such Party will cause its Affiliates and its or their Sublicensees and contractors to perform such obligations, as applicable. Either Party may use one or more of its Affiliates, Sublicensees or contractors to perform its obligations and duties or exercise its rights under this Agreement, solely to the extent permitted and as specified in this Agreement; provided, however, that (a) each such Affiliate, Sublicensees or contractor will perform any such obligations delegated to it in compliance with the applicable terms and conditions of this Agreement as if such Affiliate, Sublicensees or contractor were a party hereto, (b) the performance of any obligations of a Party by its Affiliates, Sublicensees or contractors will not diminish, reduce or eliminate any obligation of such Party under this Agreement, and (c) subject to such Party’s assignment to an Affiliate pursuant to Section 16.1, such Party will remain liable under this Agreement for the prompt payment and performance of all of its obligations under this Agreement. Subject to this Section 16.8, if a Party exercises its rights and performs its obligations under this Agreement through one or more of its Affiliates, “Sutro” will be interpreted to mean “Sutro or its Affiliates” and “BioNova” will be interpreted to mean “BioNova or its Affiliates” where necessary to give each Party’s Affiliates the benefit of the rights provided to such Party in this Agreement and the ability to perform its obligations under this Agreement.

  Section I.112.Force Majeure. Neither Party will be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay performing any obligation under this Agreement to the extent that such failure or delay is caused by or results from acts of God, embargoes, war, acts of war (whether war be declared or not), terrorism, insurrections, riots, civil commotions, strikes, lockouts, or other labor disturbances (other than strikes, lockouts, or labor disturbances involving a Party’s own employees), government actions, fire, earthquakes, floods, epidemics, pandemics or quarantines (a “Force Majeure Event”) and for so long as such failure or delay continues to be caused by or result from such Force Majeure Event. The Parties agree the effects of the COVID-19 pandemic that is ongoing as of the Effective Date may be invoked as a Force Majeure Event for the purposes of this Agreement even though the pandemic is ongoing to the extent those effects are not reasonably foreseeable by the Parties as of the Effective Date. Notwithstanding the foregoing, a Party will not be excused from making payments owed hereunder due to any such Force Majeure Event affecting such Party. The affected Party will notify the other Party in writing of any Force Majeure Event that may affect its performance under this Agreement as soon as reasonably practical, will provide a good faith estimate of 

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  the period for which its failure or delay in performance under this Agreement is expected to continue based on currently available information, and will undertake reasonable efforts necessary to mitigate and overcome such Force Majeure Event and resume normal performance of its obligations hereunder as soon as reasonably practicable under the circumstances. If the Force Majeure Event continues, then the affected Party will update such notice to the other Party on a weekly basis to provide updated summaries of its mitigation efforts and its estimates of when normal performance under this Agreement will be able to resume. 

  Section I.113.No Third Party Beneficiary Rights. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they will not be construed as conferring any rights on any other Third Party. This Agreement is not intended to and will not be construed to give any Third Party any interest or rights (including any Third Party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby, other than, to the extent provided in ARTICLE XII, the Indemnified Parties.

  Section I.114.Non-exclusive Remedy. Except as expressly provided herein, the rights and remedies provided herein are cumulative and each Party retains all remedies at law or in equity, including the Parties’ ability to receive legal damages or equitable relief, with respect to any breach of this Agreement. Neither Party will be required (but, for clarity, will have the right as specified in this Agreement) to terminate this Agreement due to a breach of this Agreement by the other Party.

  Section I.115.Interpretation. The Article and Section headings used herein are for reference and convenience only, and will not enter into the interpretation of this Agreement. Except as otherwise explicitly specified to the contrary, (a) references to an Article, Section or Exhibit means an Article or Section of, or a Schedule or Exhibit to this Agreement and all subsections thereof, unless another agreement is specified; (b) references in any Section to any clause are references to such clause of such Section; (c) references to any agreement, instrument, or other document in this Agreement refer to such agreement, instrument, or other document as originally executed or, if subsequently amended, replaced, or supplemented from time to time, as so amended, replaced, or supplemented and in effect at the relevant time of reference thereto; (d) references to a particular Laws mean such Laws as in effect as of the relevant time, including all rules and regulations thereunder and any successor Laws in effect as of the relevant time, and including the then-current amendments thereto; (e) words in the singular or plural form include the plural and singular form, respectively; (f) unless the context requires a different interpretation, the word “or” has the inclusive meaning that is typically associated with the phrase “and/or”; (g) the terms “including,” “include(s),” “such as,” “e.g.” and “for example” mean including the generality of any description preceding such term and will be deemed to be followed by “without limitation”; (h) whenever this Agreement refers to a number of days, such number will refer to calendar days unless Business Days are specified, and if a period of time is specified and dates from a given day or Business Day, or the day or Business Day of an act or event, it is to be calculated exclusive of that day or Business Day; (i) “monthly” means on a calendar month basis, (j) “quarter” or “quarterly” means on a Calendar Quarter basis; (k) “annual” or “annually” means on a Calendar Year basis; (l) “year” means a 365-day period unless Calendar Year is specified; (m) references to a particular Person include such Person’s successors and assigns to the extent not prohibited by this Agreement; (n) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to 

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  include the plural (and vice versa); (o) a capitalized term not defined herein but reflecting a different part of speech than a capitalized term which is defined herein will be interpreted in a correlative manner; (p) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein); (q) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits or Schedules); (r) neither Party or its Affiliates will be deemed to be acting “on behalf of” the other Party under this Agreement, except to the extent expressly otherwise provided; (s) provisions that require that a Party, or the JSC hereunder “agree”, “consent” or “approve” or the like will be deemed to require that such agreement, consent or approval be specific and in writing in a written agreement, letter or approved minutes, but, except as expressly provided herein, excluding e-mail and instant messaging; and (t) the word “will” will be construed to have the same meaning and effect as the word “shall” when used to indicate a Party’s obligation or duty.

  Section I.116.Further Assurances. Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement (including working collaboratively to correct and clerical, typographical, or other similar errors in this Agreement).

  Section I.117.Ambiguities; No Presumption. Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption will apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement will not be construed against any Party under the rule of construction, irrespective of which Party may be deemed to have authored the ambiguous provision.

  Section I.118.Execution in Counterparts; Facsimile Signatures. This Agreement may be executed in counterparts, each of which counterparts, when so executed and delivered, will be deemed to be an original, and all of which counterparts, taken together, will constitute one and the same instrument even if both Parties have not executed the same counterpart. Signatures provided by facsimile transmission or in AdobeTM Portable Document Format (PDF) sent by electronic mail will be deemed to be original signatures.

  Section I.119.Export Control. This Agreement is made subject to any restrictions required by applicable Laws concerning the export of products or technical information from a country which may be imposed upon or related to the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technology licensed to it or other technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at 

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  the time of export requires an export license or other governmental approval, except in compliance with applicable export Laws and regulations.

  [Remainder of this page intentionally blank.]

   

   

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  IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by its authorized representative, in duplicate on the Effective Date.

   

  Sutro Biopharma, Inc.

  __________________________________

  Name: William J. Newell

  Title: Chief Executive Officer

   

   

   

  BioNova Pharmaceuticals Limited

   

   

  ____________________________________

  Name: Ye Hua

  Title: Director

   

   

   

   

   

  [Signature Page to Option and License Agreement]

  

    

  Exhibit A

  LICENSED COMPOUND

  [*]

   

  [Signature Page to Option and License Agreement]

  

    

  Exhibit B

  LICENSED MARKS

  [*]

   

   

   

   

   

  [Signature Page to Option and License Agreement]

  

   

   

  Exhibit C

  LICENSED PATENTS

  [*]

   

   

   

   

  

    

  Exhibit D

  [*]

   

   

   

   

  

    

  Exhibit E

  BIONOVA DEVELOPMENT PLAN FOR THE TERRITORY (TERRITORY-SPECIFIC DEVELOPMENT PLAN)

  [*]

   

   

   

   

   

  2

   

  

    

  Exhibit F

  SAMPLE SUTRO INVOICE 

  [*]

   

   

  Exhibit G

  PRC SAMPLE LABEL FOR PRODUCT IMPORTATION

   

  [*]

   

   

   

  3

   

  

    

  Exhibit H

  CLINICAL SUPPLY AND BIONOVA ORDER

  [*]

   

   

   

   

  		
	 
	 

   

   

   

   

   

   

   

  4

   

  

    

  Exhibit I

  [*]

   

   

  5EX-10.29

   

  Exhibit 10.29

   

  CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO SUTRO BIOPHARMA, INC. IF PUBLICLY DISCLOSED.

   

   

  LICENSE AGREEMENT

   

   

   

  BY AND BETWEEN

   

   

   

  SUTRO BIOPHARMA, INC.

   

   

   

  AND

   

   

   

  TASLY BIOPHARMACEUTICALS CO., LTD.

   

   

   

    December 20, 2021

   

   

   

   

  		 

  

   LICENSE AGREEMENT

  This License Agreement (the “Agreement”) is entered into as of December 20, 2021 (the “Effective Date”) by and between Sutro Biopharma, Inc., a Delaware corporation with a place of business at, 111 Oyster Point Boulevard, South San Francisco, CA 94080, U.S.A. (“Sutro”) and Tasly Biopharmaceuticals Co., Ltd., a Chinese corporation with a place of business at 280 JuLi Road, China (Shanghai) Pilot Free Trade Zone, P.C.201203 (“Licensee”). Sutro and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

  RECITALS

  WHEREAS, Licensee wishes to obtain from Sutro and Sutro wishes to grant to Licensee certain rights and licenses under intellectual property Controlled by Sutro to Develop, Manufacture and Commercialize the Product in the Field in the Territory (each as defined below), subject to the terms and conditions set forth herein. 

  NOW, THEREFORE, in consideration of the foregoing and the mutual agreements set forth below, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

  Article 1
DEFINITIONS AND CONSTRUCTION

  The following terms shall have the following meanings as used in this Agreement:  

  Section 1.01“Active Ingredient” means an active material that provides pharmacological activity in a pharmaceutical or biologic product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies). Drug delivery vehicles, adjuvants and excipients will not be deemed to be Active Ingredients.

  Section 1.02“ADC” means any antibody drug conjugate whereby [*].

  Section 1.03“Affiliate” means, with respect to either Party, any Person controlling, controlled by or under common control with such Party, for so long as such control exists. For purposes of this definition of Affiliate, “control” (and, with correlative meanings, the terms “controlled by” and “under common control with”) means (a) direct or indirect ownership of fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of a Person or (b) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of a Person, whether through the ownership of voting securities, by contract or otherwise. 

  Section 1.04“Alliance Manager” shall have the meaning assigned in Section 3.01.

  Section 1.05“Annual Net Sales” means the Net Sales made during any given Calendar Year.

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  Section 1.06“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended, and any other applicable anti-corruption laws and laws for the prevention of fraud, bribery, racketeering, money laundering or terrorism in the Territory.

  Section 1.07“Applicable Laws” means all applicable statutes, ordinances, codes, executive or governmental orders, laws, rules and regulations, including without limitation, any rules, regulations, guidelines or other requirements of Regulatory Health Authorities that may be in effect from time to time.

  Section 1.08 “Bankruptcy Code” means Title 11, United States Code, as amended, or analogous provisions of Applicable Laws outside the United States.

  Section 1.09 “Biosimilar” means, with respect to the Product, any pharmaceutical product that: (a) [*]; (b) [*]; (c) [*]; (d) [*]; and (e) [*].

  Section 1.10“BLA” means (a) in the US, a Biologics License Application, as defined in the BPCI Act, and applicable regulations promulgated thereunder by the FDA, or any equivalent application that replaces such application, (b) in the Territory, the relevant equivalent to the foregoing.

  Section 1.11“BPCI Act” means the Biologics Price Competition and Innovation Act of 2009 within the Patient Protection and Affordable Care Act, as set forth in Section 351(k) of the United States Public Health Services Act (42 U.S.C. 262), which was signed into law in the United States in March 2010, as may be subsequently amended.

  Section 1.12“Breaching Party” shall have the meaning assigned in Section 11.02(a).

  Section 1.13“Business Day” means any day other than (a) a Saturday or a Sunday or (b) a day on which commercial banking institutions are authorized or required by Applicable Laws to be closed in New York City, New York, the U.S., or in Shanghai, People’s Republic of China.

  Section 1.14“Calendar Quarter” means each successive period of three (3) consecutive calendar months commencing on 1st January, 1st April, 1st July and 1st October.

  Section 1.15“Calendar Year” means each successive period of twelve (12) consecutive calendar months commencing on 1st January; provided, however, that: (a) the first Calendar Year shall commence on the Effective Date and end on December 31, 2021; and (b) the last Calendar Year shall commence on January 1 of the Calendar Year in which this Agreement terminates or expires and end on the date of termination or expiration of this Agreement.

  Section 1.16“CDx” means a [*].

  Section 1.17 “Change of Control” means, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a Third Party, 

  	3	

   

  

  together with its Affiliates, becomes the beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s business to which the subject matter of this Agreement relates. 

  Section 1.18“CMO” means a contract manufacturing organization.

  Section 1.19“Co-Chair” shall have the meaning assigned in Section 3.04.

  Section 1.20“Combination Product” means a pharmaceutical product that includes the Product and at least [*] additional Active Ingredient that [*]. 

  Section 1.21“Commercialization” means all activities undertaken relating to the marketing and sale of Product, including, advertising, detailing, education, planning, marketing, promotion, distribution, storage, transportation, importation, exportation, market and product support,  any post-approval clinical studies commenced after the First Commercial Sale of the Product in the Territory and post-approval regulatory activities, including those necessary to maintain Regulatory Approvals. “Commercialize” shall have a corresponding meaning.

  Section 1.22“Commercialization Plan” shall have the meaning assigned in Section 4.09.

  Section 1.23“Commercially Reasonable Efforts” shall mean, with respect to a Party’s obligations under this Agreement, the efforts and resources typically used by pharmaceutical companies similar in size and scope to perform the obligations at issue in good faith, which efforts shall not be less than those efforts made by the performing Party with respect to other products at a similar stage of development or in a similar market and commercial potential, taking into account the competitiveness of the market place, the proprietary position of the products, the regulatory structure involved and the profitability of the applicable products. Without limiting the foregoing, Commercially Reasonable Efforts requires, with respect to such obligations, that the Party apply efforts sufficient to carry out the given obligation in a diligent and sustained manner without undue interruption, pause, or delay. It is anticipated that the level of effort may change over time, reflecting changes in the status of the Product and the market involved.

  Section 1.24 “Competitive Product” [*].

  Section 1.25“Confidential Information” means, subject to the exceptions listed at Section 7.02, any and all non-public or proprietary information, whether oral or in writing or in any other form, disclosed before, on or after the date of this Agreement by one Party to the other Party under this Agreement, including Information, Materials and the terms of this Agreement.

  Section 1.26“Control” means, with respect to an item of Information, Know-How, Patent or other Intellectual Property Rights, the ability and authority of a Party or its Affiliates, whether arising by ownership, or pursuant to a license or sublicense, to grant licenses, sublicenses, or other rights (including the right to reference) to the other Party under or to such item of Information, Know-How, Patent or Intellectual Property Rights as provided for in this Agreement without breaching the terms of any agreement between such Party and any Third Party, and (with respect to Intellectual Property Rights that Sutro acquires Control of after the Effective Date) without creating or increasing any payment obligation to a Third Party.  Notwithstanding anything in this 

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  Agreement to the contrary, a Party and its Affiliates will be deemed to not Control any Information, Know-How, Patents or other Intellectual Property Right that are owned or controlled by a Third Party described in the definition of “Change of Control,” or such Third Party’s Affiliates (other than an Affiliate of such Party prior to the Change of Control), (a) prior to the closing of such Change of Control, or (b) after such Change of Control to the extent that such Know-How, Patents or other Intellectual Property Rights are created, conceived, discovered or generated by such Third Party or its Affiliates (other than such Party or its pre-existing Affiliates) after such Change of Control without using  such Party’s or its pre-existing Affiliate’s Know-How or Patents or other Intellectual Property Rights.

  Section 1.27“Cost of Goods” or “COGs”, means the fully burdened manufacturing costs applicable to the supply of the Product (a) supplied by an unaffiliated Third Party, or (b) manufactured directly by Sutro, which manufacturing costs:  (x) shall include [*],  (y) shall be calculated in accordance with U.S. GAAP and Sutro’s policies and procedures for its other products, in each case consistently applied (and such plant operations and support services costs shall be allocated consistent with U.S. GAAP and the other Sutro products in that facility), and (z), shall exclude [*].

  Section 1.28“Cover,” “Covered” or “Covering” means, with respect to a product, technology, process or method, that, in the absence of possession of the right (by ownership, license or otherwise) under a Valid Claim, the practice or exploitation of such product, technology, process or method would infringe such Valid Claim (or, in the case of a Valid Claim that has not yet issued, would infringe such Valid Claim if it were to issue).

  Section 1.29“CRO” means a contract research organization, as defined in 21 C.F.R. 312 or in any Applicable Laws, that assumes, as an independent contractor with the sponsor of a clinical trial, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation or reports, and preparation of materials to be submitted to the applicable Regulatory Authority.

  Section 1.30“Development” means all activities relating to obtaining Regulatory Approval of the Product and Indications therefor, but excluding activities related to the Manufacture of Product. Development activities include (a) the conduct of all preclinical and clinical testing required for Regulatory Approval of the Product, (b) the conduct of all regulatory activities directed to obtaining and maintaining Regulatory Approval of the Product. “Develop” and “Developing” shall have a corresponding meaning.

  Section 1.31“Development Data” means the Sutro Development Data or the Tasly Development Data, as the case may be.

  Section 1.32“Drug Approval Application” means an application for Regulatory Approval required for the commercial sale or use of the Product as a drug in a regulatory jurisdiction.

  Section 1.33 “Effective Date” shall have the meaning assigned in the first paragraph of this Agreement.

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  Section 1.34“Exploit” means to import, use, sell or offer for sale, including to Develop and Commercialize, the Product in the Territory (excluding for clarity Manufacturing). “Exploitation” shall have a corresponding meaning.

  Section 1.35“Export Controls and Economic Sanctions Laws” means all law regulating the export, reexport, transfer, disclosure or provision of products, software, services and technology to, and other export and international trade control activities involving, non-U.S. countries or non-U.S. Persons, and includes the Export Control Reform Act of 2018, the Export Administration Regulations, the International Emergency Economic Powers Act, the Arms Export Control Act, the International Traffic in Arms Regulations, the Chemical Weapons Convention Regulations, and any other export controls and sanctions laws and regulations administered by an agency of the U.S. government; export and import laws and regulations administered by the Bureau of Alcohol, Tobacco, Firearms and Explosives; the Foreign Trade Regulations, Executive Orders of the President regarding restrictions on trade with designated countries, governments and Persons, regulations, orders and restrictions administered by the U.S. Department of the Treasury, Office of Foreign Assets Control and any other economic sanctions or retaliatory sanctions laws and regulations administered by an agency of the U.S. government; the antiboycott regulations administered by the United States Department of Commerce; the antiboycott provisions administered by the United States Department of the Treasury; legislation and regulations implementing the North American Free Trade Agreement or the Chemical Weapons Convention, and restrictions on holding foreign currency and repatriating funds.

  Section 1.36“Expression Technology” means the Know-How and Patents Controlled by Sutro and/or its Affiliates as of the Effective Date and during the Term that relates to [*].

  Section 1.37“Extract Supply Agreement” shall have the meaning assigned in Section 5.02.

  Section 1.38“FDA” means the United States Food and Drug Administration or any successor thereto.

  Section 1.39“FFDCA” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq., as amended from time to time.

  Section 1.40“Field” means the use of the Product for the treatment of all human diseases.

  Section 1.41“Filing” means, with respect to a submission to a Regulatory Health Authority, the date that such submission is confirmed to have been received by the relevant Regulatory Health Authority.

  Section 1.42“First Commercial Sale” means, with respect to the Product, the first arm’s length sale for monetary value by Licensee, its Affiliates, or its Sublicensees to a Third Party for end use or consumption by the general public of the Product in the Territory for any Indication after all needed Regulatory Approvals (excluding reimbursement approvals) have been obtained in the Territory with respect to such Indication. Sales at nominal cost for test marketing, sampling and promotional uses, clinical trial purposes, or similar use shall not be construed as a First Commercial Sale.

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  Section 1.43“Force Majeure” and “Force Majeure Party” shall have the meaning assigned in Section 14.02.

  Section 1.44 “GCP” or “Good Clinical Practices” means the current standards for clinical trials for pharmaceuticals as are required by applicable Regulatory Authorities or Applicable Laws in the relevant jurisdiction, such as set forth in the Good Clinical Practice for Drugs (i.e.  药物临床试验质量管理规范 ) promulgated by NMPA effective as of July 1, 2020, as well as in the United States Code of Federal Regulations, ICH guidelines and applicable regulations, laws or rules as promulgated thereunder, as amended from time to time.

  Section 1.45“GLP” or “Good Laboratory Practices” means good laboratory practices required under Applicable Laws, such as the regulations set forth in 21 C.F.R. Part 58 and the requirements thereunder imposed by the FDA, and the equivalent thereof in any applicable jurisdiction, as the same may be amended from time to time.

  Section 1.46 “Government Official” means any Person employed by or acting on behalf of a Regulatory Authority.

  Section 1.47 “ICH” means the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

  Section 1.48“IND” means an Investigational New Drug application or the equivalent filed with or submitted to the relevant Regulatory Health Authority, including, for example, the FDA and the NMPA, for authorization to commence human clinical trials.

  Section 1.49“Indication” means [*]. 

  Section 1.50“Indirect Taxes” means value added taxes, sales taxes, consumption taxes and other similar taxes.

  Section 1.51“Information” means (a) techniques, information and data necessary or useful for the Development or Commercialization of the Product, including without limitation, Know-How, marketing, pricing, distribution, cost, sales and (b) any information or data relating to Materials.

  Section 1.52“Intellectual Property Rights” or “IPR” means Patents, rights to Know-How, Trademarks, registered designs, design rights, copyrights (including rights in computer software), domain names, database rights and any rights or property similar to any of the foregoing in any part of the world, whether registered or not, together with the right to apply for the registration of any such rights.

  Section 1.53“Know-How” means all inventions, discoveries, data, information (including scientific, technical or regulatory information), Trade Secrets, processes, means, methods, practices, formulae, instructions, procedures, techniques, materials, technology, results, analyses, designs, drawings, computer programs, apparatuses, specifications, technical assistance, laboratory, pre-clinical and clinical data (including laboratory notes and notebooks), and other material or know-how, in written, electronic or any other form, whether or not confidential, proprietary or patentable, including without limitation: development technology; biology, 

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  chemistry, pharmacology, toxicology, drug stability, manufacturing and formulation, test procedures, synthesis, purification and isolation techniques, quality control data and information, methodologies and techniques; information regarding clinical and non-clinical safety and efficacy studies, including study designs and protocols, marketing studies, absorption, distribution, metabolism and excretion studies; assays and biological methodology.

  Section 1.54“Knowledge” means the good faith understanding of the officers of the Party associated with the applicable representation.

  Section 1.55“Licensed Compound” means STRO-002, an ADC, the chemical structure of which is described in Exhibit B.

  Section 1.56“Licensee Technology” means all Patents and Know-How (i) Controlled by Licensee as of the Effective Date and during the Term, or (ii) that thereafter comes into Licensee’s Control independent of this Agreement. For clarity, Licensee Technology may include inventions that are broadly applicable to the Development, Manufacture or Commercialization of pharmaceutical products generally.

  Section 1.57“Licensee Triggered Termination” shall have the meaning assigned in Section 11.03.

  Section 1.58“Losses” means any and all direct and indirect liabilities, claims, actions, damages, losses or expenses, including interest, penalties, and reasonable lawyers’ fees and disbursements. In calculating Losses, the legal duty to mitigate on the part of the Party suffering the Loss shall be taken into account.

  Section 1.59“Manufacture” or “Manufacturing” means activities in connection with the manufacture, processing, formulating, testing (including, without limitation quality control, quality assurance and lot release testing), bulk packaging or storage and delivery of the Product.

  Section 1.60“Manufacturer” means Sutro or such other Person as may be appointed to supply Product to Licensee pursuant to the Supply Agreement.

  Section 1.61“Materials” means information, data or assays necessary or useful for the Development or Commercialization of Product in the Territory. Materials excludes any materials associated with Sutro Manufacturing Information.

  Section 1.62“Material Adverse Impact” shall have the meaning assigned in Section 4.07(c).

  Section 1.63“Net Sales” means the gross amount invoiced by Licensee, its Affiliates, and/or its Sublicensees for sales of the Product to Third Parties, less the following deductions and offsets that are actually incurred, allowed, accrued and/or taken and are specifically allocated with respect to such sale, but solely to the extent that such deductions or offsets are not otherwise recovered by or reimbursed to Licensee, its Affiliates and/or its Sublicensees:

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  (i)rebates, chargebacks, quantity, trade and similar discounts, credits and allowances and other price reductions granted, allowed, incurred or paid in so far as they are applied to sales of the Product;

  (ii)discounts (including cash discounts and quantity discounts), coupons, retroactive price reductions, charge back payments and rebates granted to managed care organizations or to federal, state and local governments, or to their agencies, in each case, as applied to sales of Product and actually given to customers;

  (iii)credits and allowances taken upon rejection, return or recall of the Product;

  (iv)freight and insurance costs incurred with respect to the shipment of the Product to customers, but only to the extent charged separately and invoiced to the customer;

  (v)customs duties, surcharges and other similar governmental charges (including charges for product testing required for importation) incurred in connection with the exportation or importation of the Product to the extent included in the gross amount invoiced; 

  (vi)subject to Section 6.07, taxes imposed on the production, sale, delivery or use of the Product (including sales, use, excise or value added taxes but excluding income taxes), or other governmental charges levied on or measured by the billing amount when included in billing, as adjusted for rebates and refunds; 

  (vii)  reasonable discounts due to factoring of receivables that are incurred; and

  (viii)bad debts written off which are attributable to sales of Products, provided that the aggregated allowable deductions pursuant to this sub-clause (viii) shall not exceed [*] of the gross amount invoiced.

  The methodology for calculating (i)–(viii) shall conform to P.R.C. GAAP consistently applied. No amount for which deduction is permitted pursuant to this Section shall be deducted more than once. 

  For the avoidance of doubt, sales between or among Licensee and its Affiliates or Sublicensees will be excluded from the computation of Net Sales, but the subsequent final sales to a Third Party by such Affiliate or Sublicensee will be included in the computation of Net Sales. For the further avoidance of doubt, gross amounts invoiced shall exclude value added taxes payable by Licensee as per Applicable Laws.

  Net Sales for a Combination Product in the Territory will mean the gross amount attributable to the Combination Product less the deductions set forth in clauses (i) – (viii) above, to the extent applicable and subject to the limitations set forth above, multiplied by a proration factor that is determined as follows:

  (a)If all active pharmaceutical components of the Combination Product were sold separately, the proration factor will be determined by the formula [*]; 

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  (b)If the Product components containing only the Licensed Compound as their Active Ingredient are sold separately from the other component(s), but the other Active Ingredient components in such Combination Product are not sold separately, then the proration factor will be determined by the formula [*]; 

  (c) If the Product components containing only the Licensed Compound as their Active Ingredient are not sold separately from the other component(s), but the other Active Ingredient components in such Combination Product are sold separately, then the proration factor will be determined by the formula [*]; or

  (d) If all Active Ingredient(s) of the Combination Product were not sold or provided separately, the proration factor will be determined by the Parties in good faith negotiations based on the relative value contributed by each component.

  Section 1.64“NMPA” means the National Medical Products Administration under the People’s Republic of China’s State Administration for Market Regulation, or any successor thereto. For the avoidance of doubt, the NMPA shall refer to the agency formerly known as the People’s Republic of China’s Food and Drug Administration (CFDA).

  Section 1.65 “Non-Breaching Party” shall have the meaning assigned in Section 11.02(a).

  Section 1.66“Patent” means (a) any national, regional and international patents and/or patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from any of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)), and (e) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent applications and patents.

  Section 1.67“Payments” shall have the meaning assigned in Section 6.07(a).

  Section 1.68“Person” means any individual, sole proprietorship, corporation, partnership, association, joint-stock company, trust, unincorporated organization, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

  Section 1.69“Pharmacovigilance Agreement” shall have the meaning assigned in Section 4.07(a).

  Section 1.70  “Pivotal Study” means a human clinical trial, or the relevant portion of such trial, in any country that is conducted in accordance with GCPs and the results of which are 

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  intended to be used as a pivotal study to establish both safety and efficacy of a Product as a basis for a BLA submitted to the FDA, the NMPA or the appropriate Regulatory Authority of such other country or Region, or that would otherwise satisfy the requirements of 21 C.F.R. § 312.21(c), or any successor regulation thereto or foreign equivalents. For the avoidance of doubt (subject to the footnote underneath the table set forth in Section 6.02 (under “Ovarian Cancer”, milestone event number 3)), a clinical trial that meets the foregoing criteria shall be deemed a Pivotal Study regardless of whether it is characterized as a “Phase III” clinical trial or otherwise (e.g., “Phase 2b,” or “Phase 2b/3”).

  Section 1.71“People’s Republic China” or “PRC” means the mainland of the People’s Republic of China, excluding Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan region.

  Section 1.72“PRC GAAP” means Generally Accepted Accounting Principles of the People’s Republic of China, consistently applied.

  Section 1.73“Product” means any pharmaceutical product containing the Licensed Compound, whether alone (as the sole Active Ingredient), or as part of a Combination Product. “The Product” as used in this Agreement means any and all products that satisfy this definition. 

  Section 1.74“Product-related IPR” means all Intellectual Property Rights that are discovered, invented, generated, collected, or obtained by Licensee, its Affiliates, or Sublicensees in the performance of activities conducted pursuant to this Agreement and related to the Product.

  Section 1.75“Regulatory Approval” means, with respect to the Product in any Region any approval by the applicable Regulatory Health Authority to market and sell the Product in such Region, including, where applicable, pricing or reimbursement approval in such Region.

  Section 1.76“Regulatory Authority” means any court or government body, whether national, supra- national, federal, state, local, foreign or provincial, including any political subdivision thereof, including any department, commission, board, bureau, agency, or other regulatory or administrative governmental authority or instrumentality, and further including any quasi-governmental Person or entity exercising the functions of any of these.

  Section 1.77“Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals, all correspondence submitted to or received from Regulatory Health Authorities (including minutes and official contact reports relating to any communications with any Regulatory Health Authority) and all supporting documents, including documentation arising in the course of all clinical studies and tests, in each case relating to the Product, including all INDs, BLAs, Regulatory Approvals, regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  Section 1.78“Regulatory Health Authority” or “Regulatory Health Authorities” means any applicable national (for example, FDA or NMPA), supranational, regional, state, provincial or local regulatory health authority, department, bureau, commission, council, or other government entity regulating or otherwise exercising authority with respect to the Exploitation of Product in the Territory, including any such entity involved in the granting of Regulatory Approval for pharmaceutical products.

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  Section 1.79“Remedial Action” shall have the meaning assigned in Section 4.07(b).

  Section 1.80“Review Period” shall have the meaning assigned in Section 7.07.

  Section 1.81"Safety/Efficacy Issue" means, with respect to any Product, that (a) the risk/benefit profile (based on the observation of an adverse event or otherwise) of such Product is so unfavorable that it would pose an unacceptable risk of harm in humans to Develop or Commercialize such Product, or (b) the efficacy of such Product is so minimal that it would not be commercially reasonable to continue to Develop such Product, in each case to the extent attributable to the Licensed Compound and not any other component contained in such Product or any Manufacturing-related issues. 

  Section 1.82“Senior Executives” means (a) the Chief Executive Officer of Sutro and (b) the Chief Executive Officer of Licensee. A Party shall be entitled, effective upon written notice thereof to the other Party, to designate one of its other representatives having equivalent seniority and experience to replace such foregoing representative as that Party’s Senior Executive for the purpose of this Agreement.

  Section 1.83 “Shortage” shall have the meaning assigned in Section 5.02.

  Section 1.84“Sublicensee(s)” shall have the meaning assigned in Section 2.02.

  Section 1.85“Supply Agreement” means Clinical Supply Agreement or Commercial Supply Agreement, as applicable. 

  Section 1.86“Sutro” shall have the meaning set forth in the preamble.

  Section 1.87“Sutro Corporate Trademarks” shall have the meaning set forth in Section 1.94.

  Section 1.88“Sutro Development Data” means any [*] which data is Controlled by Sutro or its Affiliates.

  Section 1.89“Sutro Know-How” means any and all Know How relating to the Product and which is necessary or useful for Licensee to obtain Regulatory Approval of the Product in the Territory, or otherwise import, Develop, or Commercialize the Product in the Territory, which exists as of the Effective Date and during the Term and is Controlled by Sutro. Notwithstanding anything to the contrary, Sutro Know-How specifically excludes all Know-How comprising Expression Technology.

  Section 1.90“Sutro Manufacturing Information” means any and all confidential documents and information relating to the Manufacture of the Product Controlled by Sutro and/or its Affiliates.

  Section 1.91“Sutro Patents” means any and all Patents that are (a) Controlled by Sutro or any of its Affiliates as of the Effective Date or at any time during the Term, and (b) necessary or reasonably useful for Licensee to import, Develop and Commercialize the Product in accordance with this Agreement, including without limitation the following: (a) patent applications and patents 

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  set forth in Exhibit A; (b) divisions, continuations, continuations-in-part, renewals, and substitute applications of any patent applications described in (a); (c) patents that may issue from any patent applications described in (a) or (b); (d) reissues, reexaminations, and extensions or restorations of patents described in (a) or (c) by existing or future extension or restoration mechanisms, including without limitation, patent restoration and supplementary protection certificates or the equivalent thereof; and € any other form of government-issued right in the Territory substantially similar to any of the foregoing. Notwithstanding anything to the contrary, Sutro Patents specifically exclude any patent applications or patents claiming or covering any processes for manufacture of Product or Expression Technology.

  Section 1.92“Sutro Product Trademarks” shall have the meaning set forth in Section 1.94.

  Section 1.93“Sutro Technology” shall mean, for purposes of this Agreement, the Sutro Know-How, Sutro Manufacturing Information, Sutro Patents, and Sutro Trademarks.

  Section 1.94“Sutro Trademarks” means the Trademarks to the extent Controlled by Sutro or its Affiliates in the Territory as of the Effective Date or during the Term and that are (a) specific to and only used with Product (the “Sutro Product Trademarks”) or (b) used in connection with, but are not specific to or used exclusively with, the Product (the “Sutro Corporate Trademarks”), each of (a) and (b) solely to the extent set forth in Exhibit E.

  Section 1.95“Target Indication” means a [*], for which a separate Regulatory Approval is required. For the avoidance of doubt, a different line of therapy or combination therapy will not be deemed a separate and distinct neoplasm. 

  Section 1.96“Tasly Development Data” means any [*], which data is Controlled by Tasly or its Affiliates.

  Section 1.97“Tax” means any form of tax or taxation, levy, duty, charge, social security charge, contribution or withholding of whatever nature (including any related fine, penalty, surcharge or interest) imposed by, or payable to, a Tax Authority.

  Section 1.98“Tax Authority” means any government, state or municipality, or any local, state, federal or other fiscal, revenue, customs, or excise authority, body or official anywhere in the world, authorized to levy Tax.

  Section 1.99“Term” shall have the meaning assigned in Section 11.01.

  Section 1.100“Territory” means the People’s Republic of China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan region (each of which for purposes of this Agreement shall each be deemed a “Region”).

  Section 1.101“Third Party” means any Person other than Sutro, Licensee, or their respective Affiliates.

  Section 1.102“Third Party Claims” shall have the meaning assigned in Section 12.01(a).

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  Section 1.103”Third Party Compensation” shall have the meaning assigned in Section 6.04(d).

  Section 1.104“Trademark” means any trademark, applications to register trademarks, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing.

  Section 1.105“Trademark License Agreement” shall have the meaning assigned in Section 2.06(b).

  Section 1.106“Trade Secret” means information, including but not limited to formulae, techniques, conditions, reagents, processes, or methods, that (i) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use; and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

  Section 1.107“Upstream Agreement” means that certain license agreement by and between Sutro and The Board Of Trustees of the Leland Stanford Junior University, dated October 3, 2007, as may be amended from time to time.

  Section 1.108“U.S. GAAP” means United States Generally Accepted Accounting Principles, consistently applied.

  Section 1.109“Valid Claim” means (a) a claim of an issued and unexpired Patent within the Sutro Patents that has not been held unpatentable, invalid, or unenforceable by a court or other government agency of competent jurisdiction in an unappealable decision or has not been admitted to be invalid or unenforceable through disclaimer, or otherwise or (b) a claim of a pending patent application within the Sutro Patents that (i) has not been abandoned, finally rejected or expired without the possibility of appeal or re-filing and (ii) [*].

  Section 1.110“Withholding Income Tax” shall mean the aggregate withholding of income tax required and levied by applicable Tax Authorities in the Territory.

  Section 1.111“Written Disclosure” shall have the meaning assigned in Section 10.02.

  Section 1.112Construction. Except where the context requires otherwise, whenever used in this Agreement, the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word “or” has the inclusive meaning represented by the phrase “and/or”. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The term “including” or “includes” as used in this Agreement means including, without limiting the generality of any description preceding such term. The article, section, and subsection headings contained in this Agreement are for the purposes of convenience only and are not intended to define or limit the contents of such articles, sections, and subsections. The wording of this Agreement shall be deemed to be the wording mutually chosen by the Parties and no rule of strict construction shall be applied against any Party.

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  Article 2
GRANT OF RIGHTS AND LICENSES; EXCLUSIVITY

  Section 2.01License to Licensee.

  (a)Subject to the terms, conditions and limitations set forth in this Agreement, including without limitation the provisions in Section 2.03 below, Sutro hereby grants to Licensee: (i) an exclusive (including with regard to Sutro and its Affiliates), royalty-bearing license during the Term to import, sell, offer for sale, Develop, and Commercialize, including without limitation repackage and have repackaged Products in the Field in the Territory,  with the right to grant sublicenses solely in accordance with Section 2.02 below, under Sutro Know-How and Sutro Patents (but specifically excluding Sutro Manufacturing Information and any aspects of the Sutro Patents related thereto ). For the avoidance of doubt, the license granted in this Section 2.01 does not include the right to (i)[*]  (ii)[*], or (iii)[*] .

  (b)Subject to the terms, conditions and limitations set forth in this Agreement, Licensee shall have the right to engage and appoint service providers, at its own discretion for the sole purpose of conducting clinical development, obtaining Regulatory Approval or import authorization, importing, and/or transportation services (but excluding any distribution and promotional activities) in relation to the Product on behalf of Licensee in the Territory in accordance with this Agreement. For avoidance of doubt, the Affiliates and the Sublicensee (as defined in Section 2.02) of Licensee shall also have the right to engage and appoint service providers at its own discretion for the aforementioned purposes. These service providers shall be bound by obligations of confidentiality that are no less restrictive than those contained in this Agreement and provisions sufficient to ensure that any Product-Related IPR developed by such service providers within the scope of their engagement will be fully assigned to Licensee. Licensee shall remain liable for any action or failure to act by any service provider if such action or failure to act by the service provider would have constituted a breach of this Agreement if such action or failure were committed by Licensee.

  Section 2.02Sublicenses. Licensee shall have the right to grant sublicenses under the license granted to Licensee under Section 2.01 in each case only upon prior written consent (such consent not to be unreasonably withheld, conditioned or delayed) of Sutro and subject to the remainder of Section 2.02, provided that Licensee may grant sublicenses to its Affiliates without prior written notice to Sutro so long as such Affiliate remains an Affiliate of Licensee. Where Licensee or its Affiliates grants such sublicense to a Person that is not an Affiliate of Licensee, such Person shall be a “Sublicensee” for the purposes of this Agreement, and any Person to which a Sublicensee grants a further sublicense shall also be a Sublicensee; provided, however, that any Person that is engaged and appointed by Licensee, its Affiliates and/or Sublicensees as a service provider pursuant to Section 2.01(b) solely to enable such Person to provide such services shall not be a “Sublicensee” for purposes of this Agreement. Licensee, its Affiliates and its Sublicensees shall ensure that all Persons to which they grant sublicenses (a) comply with all terms and conditions of this Agreement, and, without limiting the foregoing (b) are bound by obligations of confidentiality that are no less restrictive than those contained in this Agreement and provisions sufficient to ensure that any Product-Related IPR developed by them will be fully assigned to Licensee, (c) agree to comply with 4.06(c) to the same extent Licensee is obligated thereunder, and (d) do not have the right to grant further sublicenses. Within [*] days after the execution of 

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  each sublicense agreement, Licensee shall provide to Sutro a copy of such each agreement (which may be redacted to remove any sensitive information not necessary for Sutro to verify its compliance with the terms of this Agreement). Licensee shall remain liable for any action or failure to act by any Sublicensee under the licenses granted in Section 2.01 by Licensee, its Affiliates or its Sublicensees, if such action or failure to act by the Sublicensee would have constituted a breach of this Agreement if such action or failure were committed by Licensee. In the event of early termination of this Agreement, all sublicenses granted to Sublicensees in accordance with the terms hereof shall automatically be revoked without any further action on the part of Sutro.

  Section 2.03Rights Retained by Sutro. Notwithstanding the foregoing, Sutro hereby expressly retains (on behalf of itself and its Affiliates) (a) all rights to any Sutro Know-How and Intellectual Property Rights, including the Sutro Manufacturing Information, related to the Manufacture of the Product (which rights are excluded from the license grant in Section 2.01), (b) the right under the Sutro Technology to conduct global studies with respect to the Product in accordance with this Agreement, and (c) all exclusive rights under the Sutro Technology to Develop, Manufacture, Commercialize and otherwise exploit the Product outside of the Territory, whether within or outside of the Field. For clarity, this Section 2.03 shall not be construed to limit Licensee’s rights under Section 5.02(b).

  Section 2.04No Implied Rights; Negative Covenant. This Agreement confers no right, license, or interest by implication, estoppel, or otherwise under any Patents, Know-How, or other Intellectual Property Rights of either Party except as expressly set forth in this Agreement. Each Party hereby expressly retains and reserves all rights and interests with respect to Patents, Know-How, or other Intellectual Property Rights not expressly granted to the other Party hereunder. Without limiting the generality of the foregoing, no license or other rights are granted to Licensee under this Agreement to any pharmaceutical compositions claimed or disclosed in any Sutro Patents other than the Product. Licensee shall not, and shall not permit any of its Affiliates or Sublicensees to, practice any Intellectual Property Rights licensed to it by Sutro outside the scope of the licenses granted to it under this Agreement. 

  Section 2.05Non-Compete. Upon the Effective Date and throughout the Term, Licensee shall not, and shall ensure that its Affiliates and Sublicensees do not, engage in, independently or for or with any Third Party, any research, development, manufacture or commercialization of any Competitive Product. In the event that Licensee and/or any of its Affiliates undergoes an  acquisition of or merger with a Third Party, which will become an Affiliate of Licensee immediately after closing of such acquisition or merger transaction, and such Third Party is engaging in the development and/or commercialization of any Competitive Products at the time of such transaction, Licensee will notify Sutro immediately after the closing of such transaction to initiate a discussion with Sutro and suspend the development and/or commercialization of such Competitive Products unless and until the Parties reach an agreement on this competitive business during or after such discussion with Licensee in good faith. Notwithstanding the above, in the event that an Affiliate of Licensee is (a)[*] ; or (b)[*] .

  Section 2.06Trademark Rights.

  (a)Sutro Trademarks. Subject to the terms, conditions and limitations set forth in this Agreement, Sutro hereby grants to Licensee a royalty-free exclusive license to use Sutro 

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  Trademarks, including Sutro Product Trademarks and (solely upon Sutro’s prior written consent in each case, which consent shall not be unreasonably withheld) Sutro Corporate Trademarks, solely in connection with the Commercialization of the Product in the Territory. All representations and uses of Sutro Trademarks that Licensee intends to use will first be submitted to Sutro for approval, such approval not to be unreasonably withheld. Sutro will have [*] to review the representation and uses of the Sutro Trademarks. If Sutro does not provide written notice of its approval or disapproval (together with its reasons for such disapproval) within such [*] period, Sutro will be deemed to have approved such representation.

  (b)In connection with the license granted to Licensee under the Sutro Trademarks as provided in Section 2.06(a), Sutro and Licensee agree that either they or their respective Affiliates will, within [*] after the Effective Date or otherwise agreed by both Parties, negotiate in good faith the terms of a “Trademark License Agreement”, which shall not be inconsistent with the terms and conditions of this Agreement, including this Section 2.06, and shall be filed with the appropriate governmental body in the Territory if required under Applicable Laws.

  (c)Notwithstanding the above, Licensee shall have the right to select its own Trademarks and/or apply for new Trademarks in its own name, at its own discretion, to be used for the Commercialization of the Product in the Territory (the “Licensee Trademarks”).  Licensee shall solely bear the full costs and expense of and be responsible for filing, prosecuting and maintaining all the Licensee Trademarks. Licensee shall, at its sole discretion, protect, defend, and maintain each Licensee Trademark for use with Product in the Territory, and all registrations therefor.

  (d)Licensee shall be responsible for and have the discretion in determining the design and procurement of all packaging (non-commercial and commercial) and labeling of the Product.

  Article 3
GOVERNANCE

  Section 3.01Alliance Manager. Within [*] of the Effective Date, each Party will identify and notify the other Party of a representative to act as its informal liaison under this Agreement (the “Alliance Manager”). The Alliance Managers will serve as the primary contact points between the Parties regarding the activities contemplated by this Agreement. The Alliance Managers may facilitate the flow of information and otherwise promote communication, coordination and collaboration between the parties, providing single point communication for seeking consensus both internally within each Party’s organization, including facilitating review of external corporate communications, and raising potential disputes in a timely manner. Each Party may change its Alliance Manager by written notice to the other Party.

  Section 3.02Joint Steering Committee. Within [*] of the Effective Date, the Parties shall establish a Joint Steering Committee (the “JSC”). Each Party can designate three representatives as the members to the JSC, and such initial members to be nominated by the Parties and listed at Exhibit C herein. Such representatives shall be individuals suitable in seniority and experience and having delegated authority to make decisions of the JSC with respect to matters within the scope of the JSC’s responsibilities. The JSC shall operate in accordance with the provisions of Section 3.03 to Section 3.07, and shall have no authority to alter, amend or waive the terms and conditions 

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  of this Agreement, including any payment conditions or terms, periods of performance, or obligations of the Parties. A Party may change one or more of its representatives serving on the JSC at any time upon written notice to the other Party; provided that such replacement is of comparable authority and scope of functional responsibility within that Party’s organization as the person he or she is replacing. At its meetings, the JSC shall discuss the matters described below and such other matters as are reasonably requested by either Party’s Alliance Manager. The JSC shall remain in effect as from its establishment through the Term.

  Section 3.03Responsibilities of JSC. Except as specifically provided in this Agreement, the role of the JSC shall be advisory in nature, with the main purpose of serving as a forum for the sharing of information and facilitating communications between the Parties regarding Development and Commercialization activities conducted hereunder, including by keeping Sutro reasonably informed and updated regarding (i) the status of Development and Commercialization, (ii) results from any clinical trials, (iii) any adverse events, and (iv) material correspondence with a Regulatory Authority. Subject to Section 3.07, the responsibilities of the JSC will be to:

  (a)review and approve the Development strategy and the Development Plan for the Product in the Territory;

  (b)review and advise on the Commercialization Plan ; 

  (c)ensure harmonization of the Product Development and regulatory strategy in the Territory with Sutro’s global development and commercialization strategy (for clarity, Sutro shall have no obligation to conduct any global study for the Product);

  (d)review and discuss matters that may have a Material Adverse Impact; 

  (e)oversee and advise on all pre-clinical and/or clinical Development activities proposed to be conducted with respect to the Product;

  (f)review and discuss the protocols for each clinical trial of Product proposed to be conducted in the Territory;

  (g)facilitate and approve the exchange of Product-related data and information between the Parties;

  (h)facilitate and approve the clinical trial data publication strategy for trials conducted in the Territory; and

  (i)oversee the implementation of, and the coordination between the Parties of activities to be performed under the Development Plan, Pharmacovigilance Agreement, Supply Agreement, and any other written agreement between the Parties with respect to the subject matter hereof. 

  (j)perform such other functions as are specifically designated for the JSC in this Agreement.

  Section 3.04Co-Chairs. Each Party shall designate one of its representatives on the JSC to co-chair the meetings for the JSC (each, a “Co-Chair”). The Co-Chairs shall, through and with the assistance of the Alliance Managers, coordinate and prepare the agenda for, and ensure the 

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  orderly conduct of, the meetings of the JSC. The Co-Chairs shall, through and with the assistance of the Alliance Managers, solicit agenda items from the JSC members and provide an agenda, along with appropriate information for such agenda, reasonably in advance of any meeting. Such agenda shall include all items requested by either Co-Chair for inclusion therein. In the event the Co-Chairs or another JSC member from either Party is unable to attend or participate in a meeting of the JSC, the Party whose Co-Chair or member is unable to attend may designate a substitute co-chair or other representative for the meeting.

  Section 3.05Meetings. The JSC shall meet at least quarterly, or more or less frequently if determined by the JSC, during the period in which Licensee is Developing the Product in the Territory, and JSC meetings can be called at other times by agreement between the Parties for any reason. JSC meetings may be conducted by telephone, videoconference or in person. Any in-person JSC meetings shall be held on an alternating basis between Sutro’s and Licensee’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for the cost of such Party’s own personnel and for its own expenses in attending such meetings and carrying out the other activities contemplated under this Article 3. As appropriate, the JSC may invite a reasonable number of non-voting employees, consultants and scientific advisors to attend its meetings as non-voting observers; provided, that such invitees are bound by confidentiality obligations at least as stringent as the provisions set forth herein. Each Party may also call for special meetings of the JSC to discuss particular matters requested by such Party. The Alliance Managers shall provide the members of the JSC with no less than [*] notice of each regularly scheduled meeting and, to the extent reasonably practicable under the circumstances, no less than [*] notice of any special meetings called by either Party.

  Section 3.06Minutes. Minutes will be kept of all JSC meetings, with the minutes for each JSC meeting to be the responsibility of the Co-Chair (or his or her designees) of the Party that is hosting such meeting, unless otherwise agreed by the Parties. Draft meeting minutes shall be sent to all members of the JSC by e-mail for review and approval within [*] after each such meeting. Minutes will be deemed approved unless any member of the JSC objects to the accuracy of such minutes by providing written notice to the other members of the JSC prior to the next meeting. Minutes shall [*]. In the event of any objection to the minutes that is not resolved by mutual agreement of the Parties, such minutes will be amended to reflect such unresolved dispute.

  Section 3.07Decision Making of JSC. Decisions of the JSC shall be made by unanimous vote, with each Party’s representatives on the JSC collectively having one vote. Any matter which the JSC is unable to resolve [*] within [*] shall be referred to the Parties’ Senior Executives as set forth in Section 13.01, provided, however that if the Senior Executives are unable to resolve such matter as set forth in Section 13.01, then: (i) if the matter relates to global Development (including Development activities in the Territory as a part of  a global development plan) of the Product, or could otherwise result in a Material Adverse Impact, Sutro shall have the final decision and (ii) [*] Licensee shall have the final decision. In no event shall either Party be permitted to use its decision making authority under this Section 3.07 to supersede its diligence obligations under this Agreement, and each Party’s final decision shall comply with the Applicable Law.

  Article 4
GENERAL PROVISIONS ON DEVELOPMENT AND COMMERCIALIZATION

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  Section 4.01Record Keeping. Each Party shall maintain, or cause to be maintained, records of its activities under this Agreement [*], to the extent related to the Development of the Product in the Territory, which shall be complete and accurate [*].

  Section 4.02Development Plan. Licensee shall be responsible for providing to the JSC for approval reasonably detailed plans specifying the Development activities, including clinical trials and regulatory submissions, planned for the Product in the Territory with respect to each Indication for which it is seeking Regulatory Approval, and the timelines for achieving such activities (the “Development Plan”); provided, however, that an initial draft of the Development Plan is attached hereto as Exhibit D. Such initial Development Plan shall be non-binding and may be adjusted according to the liaisons with the Regulatory Authorities in the United States and/or in the Territory, but the subsequent Development Plans provided by Licensee shall be guided by the initial Development Plan, adjusted and finalized according to the approval (or consent in case of no formal approval) of the pivotal clinical trial design by the Regulatory Authorities in the US and in the Territory. Sutro shall have the right to comment, and the Parties shall discuss in good faith, prior to the submission of the Development Plans to the JSC for approval. From time to time, but at least every [*], Licensee shall propose updates or amendments to the Development Plan in consultation with Sutro to reflect changes in the plans, including timelines for activities therein. Thereafter, Licensee shall submit the proposed updated or amended Development Plan to the JSC for review and approval.

  Section 4.03Conduct of Certain Development Activities. Subject to the terms of the Agreement, Licensee shall have the sole right and responsibility for the Development of the Product in the Field throughout the Territory, including the conduct of clinical trials and other Development studies, at its own cost and expense; provided, however, Sutro may sponsor or co-sponsor such clinical studies with respect to the Product pursuant to Applicable Laws as part of a global development plan, in which case Sutro shall use Commercially Reasonable Efforts to cooperate with Licensee to conduct such clinical trials in the Territory. Licensee may support Sutro’s global development of Product by conducting certain Development activities in the Territory as reasonably requested by Sutro, provided that for any such Development activities conducted at Sutro’s request but not required for obtaining the Regulatory Approvals in the Territory (and provided that no resulting data is used for obtaining the Regulatory Approvals in the Territory), Sutro shall reimburse Licensee for all the costs and expenses associated therewith. Any Development activities to be performed by Licensee that relate to Sutro’s global development of the Product may be included in the Development Plan. 

  Section 4.04Diligence Obligations.

  (a)Licensee shall use Commercially Reasonable Efforts in accordance with the Development Plan [*] to carry out its activities under this Agreement to Develop (in accordance with the Development Plan) and Commercialize the Product in the Territory. For the avoidance of doubt, upon the execution of this Agreement, Licensee shall be responsible for preparing [*] all Development and Commercialization activities required for   commercial success of the Product in the Territory, including but not limited to the following activities:

  (i)prepare the subsequent Development Plan contemplated by Section 4.02 above within [*] of the Effective Date;

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  (ii)prepare a preliminary Commercialization Plan contemplated by Section 4.09 hereunder no later than [*] prior to the anticipated date of filing of the first BLA or Drug Approval Application for the Product in the Territory;

  (iii)obtain the first informed consent of the first patient for the first clinical trial for the Product in the Territory within [*] of obtaining all regulatory clearances required under Applicable Laws to commence such trial, including but not limited to, IND clearance, hospital ethics committee approval and Human Genetic Resources Administration of China approval.

  (iv)make timely regulatory submissions and filings in the Territory as is customary with industrial practices in the Field in the Territory; and

  (v)within [*] following receipt of the Regulatory Approval (excluding reimbursement approvals) for the Product in the Field in the PRC, effect the First Commercial Sale of such Product in the PRC, except to the extent [*] or is due to circumstances beyond the reasonable control of Licensee. 

  Section 4.05Reports of Development Activities. Licensee shall prepare and provide reports on the Development activities of the Product undertaken by it in the Territory at each meeting of the JSC. [*] In addition, as reasonably requested by Sutro, Licensee shall, at its own expense, make appropriate scientific and regulatory personnel available at JSC meetings to brief the JSC on Development activities conducted by Licensee. All of the documentation described in this Section 4.05 shall be provided to Sutro in English.

  Section 4.06Regulatory Matters.

  (a)Sutro acknowledges that Applicable Laws may require that the Product be registered through the imported drug pathway of the NMPA, and Sutro or its designated agent, as the marketing authorization holder in the United States, be the marketing authorization or imported drug license holder of the Product in the Field in the Territory. Notwithstanding the foregoing sentence, however, Sutro shall not have any right to Commercialize the Product in the Field in the Territory, which have been granted to Licensee under Section 2.01. In the event Sutro is no longer required under Applicable Laws to be the marketing authorization or imported drug license holder in the Territory, then Sutro shall promptly transfer the marketing authorization or imported drug license to Licensee (and Licensee shall accept such transfer) and shall not require Licensee to make additional payment on such transfer, except that Licensee shall promptly reimburse Sutro for any and all reasonable expenses ([*]) that Sutro may incur in being and transferring to Licensee the marketing authorization or imported drug license in the Territory.

  (b) Subject to the terms and conditions of this Agreement, Licensee will be responsible, at its sole cost and expense, for all regulatory activities leading up to and including the submitting and obtaining of INDs, Regulatory Documentation, Regulatory Approvals, for the Products in the Field in the Territory from Regulatory Authorities in the Territory, provided that, Licensee will conduct such activities (and any and all regulatory activities delegated to Licensee in this Agreement) (1) in its own name, if Licensee is the holder and legal and beneficial owner of the INDs, Regulatory Documentation, and Regulatory Approvals for the Product in the Field in 

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  the Territory, or (2) as the express and authorized regulatory agent of record for Sutro in the Field in the Territory (unless a mutually agreed upon CRO has been appointed to perform such function as set forth in Section 4.06(d)), if Sutro is the legal and beneficial owner of the INDs, Regulatory Documentation, and Regulatory Approvals for the Product in the Field in the Territory, under which situation such actions will be taken on behalf of Sutro and for the benefit of Licensee in the Field in the Territory.    

  (c)Licensee shall use Commercially Reasonable Efforts, on behalf of Sutro (if applicable), to apply for the Regulatory Approval for the Product in the Territory for all Indications specified in the Development Plan. Licensee shall be responsible for (i) preparing, translating, filing and submitting all Regulatory Documentation related to the Product with the applicable Regulatory Health Authority(ies) in the Territory, including all applications for Regulatory Approval, at its own cost, (ii) as soon as reasonably practicable, providing to Sutro the English translation of such Regulatory Documentation submitted,  to the extent such Regulatory Documentation is not translated from materials provided by Sutro, at its own cost, and (iii)  providing   to Sutro all correspondence with Regulatory Health Authority(ies) in the Territory (each of the foregoing translated in English), at its own cost. Licensee shall also be responsible for providing, in the format required by the applicable Regulatory Health Authorities, the data and information required to be submitted to such Regulatory Health Authorities for Regulatory Approval of the Product in the Territory, including without limitation data from all clinical trials in the Territory. 

  (d)As soon as reasonably practicable following the Effective Date, Sutro shall[*] provide to Licensee, all reasonably necessary data and other clinical development information (including manufacturing batch records) pertaining to the Product and Controlled by Sutro, and all necessary certification documents for IND application, BLA equivalent application or Drug Approval Application in the Territory. The technical documents, including but not limited to spectrum and chromatogram derived from Chemistry, Manufacturing, and Controls (CMC) (excluding, for clarity, data pertaining to Expression Technology), preclinical or clinical studies, provided by Sutro shall be in CTD or eCTD format. Upon   request by the applicable Regulatory Health Authorities, Sutro shall also provide, if applicable, available specification validation samples and reference standards for the Product. In addition, to the extent necessary for Licensee to obtain Regulatory Approval of a Product in the Territory, [*]. Notwithstanding the above, if allowed under Applicable Laws, any access by any Regulatory Health Authority to any information relating to Expression Technology shall be provided via (i) a right of reference to a drug master file (or DMF) (or its equivalent in the applicable Region in the Territory) filed by Sutro in the applicable Region in the Territory or (ii) directly to a Regulatory Health Authority by Sutro [*].  

  (e)Sutro shall use Commercially Reasonable Efforts to attend all meetings or hearings where Sutro’s presence is specifically requested by the applicable Regulatory Authority, by telephone, videoconference or (if requested by such Regulatory Authority) in person, provided that Licensee shall [*]. In addition, Sutro acknowledges that the NMPA generally requires applicants to provide responses to its questions and requests within [*], and shall provide Licensee with all reasonable assistance in responding to questions and requests raised by NMPA and other Regulatory Health Authorities within the required timeframe. 

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  (f)Licensee shall report to Sutro regarding the status of each pending or proposed IND application, BLA equivalent application or Drug Approval Application covering the Product in the Territory. Licensee shall as soon as reasonably practicable furnish Sutro with English language copies of all substantive correspondence Licensee has had with any Regulatory Health Authority, and contact reports concerning substantive conversations or substantive meetings with any Regulatory Health Authority, in each case relating to any such IND, BLA equivalent or Drug Approval Application.

  (g)Licensee shall be responsible for [*], ensuring the accuracy and fidelity of the translation, of any and all documents provided to Regulatory Health Authorities and/or Sutro, as applicable, under this Section 4.06.

  (h)Each Party (i) hereby grants to the other Party and its Affiliates a right of reference to all Regulatory Documentation and, Regulatory Approvals  Controlled by the first Party and its Affiliates and (ii) will provide to the other Party with access to the Development Data Controlled by the first Party or its Affiliates, in each case under (i) and (ii) to the extent  necessary or useful for the Development, Manufacture, Commercialization or other exploitation of the Product in the Field in the other Party’s territory, subject in each case to the last sentence of Section 4.06(d). The receiving Party and its Affiliates (A) shall have the right to use such Regulatory Documentation, Regulatory Approvals and Development Data only in connection with the Development, Manufacture, Commercialization or other exploitation of the Product in the Field in such Party’s territory, and (B) may sublicense the rights granted to it under this Section 4.06(h) to its licensees (in the case of Sutro) or Sublicensees (in the case of Tasly), provided that such licensees or Sublicensees have granted to Sutro and Tasly a reciprocal, sublicensable right with respect to the Regulatory Documentation, Regulatory Approvals and Development Data of such licensees and Sublicensees, as applicable. Each Party shall use reasonable efforts to obtain the consent of its licensees (in the case of Sutro) and Sublicensees (in the case of Tasly) to grant to the other Party and its Affiliates the rights described above with respect to the Regulatory Documentation, Regulatory Approvals and Development Data of such licensees and Sublicensees, as applicable.  

  Section 4.07Adverse Event Reporting and Product Recall; No Material Adverse Impact

  (a)Each Party agrees to provide the other Party with the necessary safety information required by Regulatory Health Authorities to comply with Applicable Laws. Sutro will hold the safety database for the Product and Licensee will provide safety information as required by Applicable Laws, in a timely manner, subject to a reasonable cost sharing arrangement to be agreed-upon in the Pharmacovigilance Agreement (as defined below). [*] following the Effective Date, but no later than [*] after the Effective Date or otherwise agreed by both Parties, the Parties will enter into a detailed pharmacovigilance agreement (the “Pharmacovigilance Agreement”), governing, among other things, appropriate adverse event reporting procedures and pharmacovigilance responsibilities of the Parties relating to Product and reflecting the provisions set forth above in this Section 4.07(a).

  (b) Each Party will notify the other Party [*] (in any event within [*]), if it obtains information indicating that any Product could reasonably expected to be subject to any recall, corrective action or other regulatory action taken by virtue of Applicable Laws (a “Remedial 

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  Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Licensee shall, and shall ensure that its Affiliates and Sublicensees will, maintain adequate records to permit the Parties to trace the packaging, labeling, distribution, sale and use (to the extent possible) of the Product in the Territory. Licensee shall have sole discretion and responsibilities with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action in the Territory; provided, however, if Sutro determines in good faith that any Remedial Action with respect to any Product in the Territory should be commenced or is required by Applicable Laws or Regulatory Authority, (a) Sutro shall discuss such Remedial Action with Licensee and (b) Licensee shall carry out such Remedial Action upon Sutro’s request. Each Party shall provide the other Party with such assistance in connection with a Remedial Action as may be reasonably requested by such other Party. The Party responsible for the related loss, damage, adverse effects, accidents or product liability of any kind whatsoever shall be determined according to the circumstances of the event, including but not limited to: (i) defective quality of Product, (ii) inaccurate advertising, (iii) marketing issues, (iv) improper storage, and (v) infringement, and shall be responsible for and cover all costs and expenses associated with the Remedial Action.  

  (c)Licensee will [*] notify Sutro any communication or correspondence with any Regulatory Authority that, to its knowledge, may affect the Development, Manufacture or Commercialization of the Product in the Field outside the Territory. Without limiting the foregoing, in the event that any Development, Manufacture or Commercialization activities hereunder (whether by Licensee, its Affiliates or their respective Sublicensees) could, to Licensee’s knowledge, cause any material delay or material negative consequences on the Development, Manufacture or Commercialization of the Product in or outside the Field anywhere in the world including outside of the Territory (“Material Adverse Impact”), Licensee will [*]  notify the JSC of any such activities, and the matter shall be resolved as set forth in Section 3.07. Without limiting the foregoing, unless the Parties otherwise agree in writing: (a) Licensee shall not communicate with any Regulatory Authority having jurisdiction outside the Territory, unless so ordered by such Regulatory Authority, in which case Licensee shall promptly notify Sutro of such order; and (b) Licensee shall not submit any Regulatory Documentation or seek Regulatory Approvals for the Product outside the Territory.  

  Section 4.08General Provisions Regarding Commercialization. 

  (a)Licensee will control and perform, itself or through its Affiliates, or Sublicensees, the Commercialization of the Product throughout the Territory and, as a result, shall be obligated and responsible for using Commercially Reasonable Efforts to carry out such Commercialization in accordance with the Commercialization Plan (as defined below). Except to the extent otherwise described in this Agreement, Licensee will be solely responsible for, and will bear all costs relating to, the Commercialization of the Product in the Territory.

  (b)Sutro shall use Commercially Reasonable Efforts to support Licensee’s post-approval regulatory activities with respect to the Product in the Territory, including those necessary to maintain Regulatory Approvals in the Territory, as reasonably requested by Licensee at Licensee’s cost (provided that internal FTE costs incurred by Sutro shall only be reimbursed to the extent the time cap in Section 4.12 is exceeded). 

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  Section 4.09Commercialization Plan. Licensee shall be responsible for providing to the JSC for review a [*] plan specifying the major Commercialization activities, including revenue targets and regional price strategy, planned for the Product in the Territory with respect to each Indication for which it is seeking Regulatory Approval, and the timelines for achieving such activities (the “Commercialization Plan”).  Licensee shall deliver an initial draft of the Commercialization Plan to Sutro for Sutro’s review no later than [*] prior to the anticipated date of filing of the first BLA or Drug Approval Application for the Product in the Territory. Sutro shall have the right to comment prior to the submission of the Commercialization Plan to the JSC for review. Thereafter, from time to time, but at least every [*], Licensee shall propose updates or amendments to the Commercialization Plan in consultation with Sutro to reflect changes in the plans, including those in response to changes in the marketplace, relative commercial success of the Product, and other relevant factors that may influence such plan and activities. Licensee shall submit the proposed updated or amended Commercialization Plan to the JSC for review.

  Section 4.10Reports of Commercialization Activities. For each Calendar Year following the first Regulatory Approval of the Product in the Territory, Licensee shall provide to Sutro [*] a written report that summarizes the Commercialization activities performed by or on behalf of Licensee, its Affiliates and Sublicensees in the Territory since the prior report by Licensee. Such report shall contain sufficient detail to enable Sutro to assess Licensee’s compliance with its Commercialization obligations in Section 4.08. Such reports shall be Confidential Information to Licensee pursuant to Article 7. Licensee shall provide updates to any such reports at JSC meetings, as necessary, including quarterly updates on the progress toward achieving Sales Milestones Events under Section 6.03.

  Section 4.11No Diversion. Each of Sutro and Licensee hereby covenants and agrees that (a) it shall not, and shall ensure that its Affiliates, subcontractors and (sub)licensees shall not, directly or indirectly, promote, market, distribute, import, sell or have sold the Product, including via internet or mail order, outside its territory; (b) with respect to any country or region outside its territory, it shall not, and shall ensure that its Affiliates, subcontractors and (sub)licensees shall not: (i) unless otherwise agreed by the Parties in writing, establish or maintain any branch, warehouse or distribution facility for Product in such countries (except, in the event such Party is Licensee, Licensee shall have the right to maintain one or more warehouses outside the Territory solely to support the packaging and labelling activities of the Product by Licensee or its Affiliates outside the Territory and, in the event such Party is Sutro, Sutro shall have the right to maintain one or more warehouses in the Territory solely to support its retained rights provided under Section 2.03), (ii) engage in any advertising or promotional activities relating to Product that are directed primarily to customers or other purchaser or users of Product located in such countries, (iii) solicit orders for Product from any prospective purchaser located in such countries, or (iv) sell or distribute Product to any Person in such Party’s territory who, to the knowledge of such Party (following reasonable inquiry), intends to sell or has in the past sold Product in such countries; (c) if a Party receives any order for any Product from a prospective purchaser reasonably believed to be located in a region or country outside its territory, such Party shall promptly refer that order to the other Party, and such Party shall not accept any such orders; (d) neither Party shall deliver or tender (or cause to be delivered or tendered) Product into a country or region outside its territory, except that Sutro shall have the right to do so solely to support its retained rights provided under Section 2.03, and € each Party shall not, and shall ensure that its Affiliates and their respective subcontractors and sublicensees shall not, knowingly restrict or impede in any manner the other 

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  Party’s exercise of its rights to Commercialize the Product in the other Party’s territory. For the purpose of this Agreement, Licensee’s territory shall mean the Territory and Sutro’s territory shall mean all countries and regions outside the Territory.

  Section 4.12Limitation on Sutro’s Obligations. The Parties acknowledge and agree that, notwithstanding anything to the contrary hereunder, Sutro’s obligation to provide any form of assistance to Licensee under this Article 4 (including under Sections 4.06 and 4.08(b)) shall be subject to the following: (a) Sutro will provide such assistance [*]  until the [*] ,  (b) thereafter, Sutro will provide such assistance [*] for up to [*] annually, (c) Sutro will provide any such additional assistance, upon Licensee’s reasonable request in each case, at the then-applicable Sutro’s FTE rate, and (d) [*] by Sutro in connection with the activities under the foregoing sub-clauses (a)-(c) shall be [*] reimbursed by Licensee. 

   

  Article 5
SUPPLY

  Section 5.01Supply.

  (a)Sutro shall be responsible for supplying Product to Licensee to allow Licensee to conduct its Development and Commercialization activities in the Territory under this Agreement, as the Parties shall agree to in separate supply agreements. Within [*] of the execution of this Agreement, the Parties will negotiate and agree in good faith the terms of, and will enter into, a full, separate manufacturing and supply agreement, covering supplies of Product for the clinical trials in the Territory (the “Clinical Supply Agreement”). No later than [*] prior to the anticipated first Regulatory Approval of the Product in the Territory, and within [*] following Licensee’s written request, the Parties will either revise or enter into a new manufacturing and supply agreement, covering ordering and supplies for Commercialization purposes in the Territory (the “Commercial Supply Agreement”). The Clinical Supply Agreement and Commercial Supply Agreement shall provide specific terms and obligations concerning, among other things, forecasts, purchase orders, and supply of Product for the Territory, in accordance with Section 5.01(b)-(d) below, and the Clinical Supply Agreement shall include the material terms set forth on Exhibit F. The Parties shall also enter into a separate Quality Assurance Agreement (“Quality Agreement”) within [*] upon the Effective Date or otherwise agreed by both Parties. Such Quality Agreement shall define the manufacturing and supply quality responsibilities negotiated in good faith between the Parties. Sutro shall use Commercially Reasonable Efforts to ensure that any manufacturing agreement entered into with any Third Party to manufacture the Product under this Agreement contain a provision providing Licensee and its Affiliates with industry-standard indemnification, including against product liability claims.

  (b)Development Supply. For supply of Product for Development (including all clinical or regulatory supplies necessary to obtain Regulatory Approval in the Territory) in the Territory, Sutro shall supply Product to Licensee for each Indication in accordance with the Clinical Supply Agreement at a price equal to:

  (i)For Product (or components thereof) manufactured by Sutro or its Affiliates: [*] of Sutro’s Cost of Goods; 

  	26	

   

  

  (ii)For Product (or components thereof) sourced by Sutro from one or more CMOs: the [*] by Sutro to such CMO(s) for the manufacture and supply of such Product, and any associated third-party costs (e.g., insurance and shipping) plus a [*]. 

  (c)Commercial Supply. For supply of Product for Commercialization purposes, Sutro shall be responsible for supplying such Product to Licensee in accordance with the Commercial Supply Agreement at a price equal to:

  (i)For Product (or components thereof) manufactured by Sutro or its Affiliates: [*] of Sutro’s Cost of Goods; (ii) For Product (or components thereof) sourced by Sutro from one or more CMOs: the actual invoiced price paid by Sutro to such CMO(s) for the manufacture and supply of such Product, and any associated third-party costs (e.g., insurance and shipping) plus a [*]. 

  (d)The Commercial Supply Agreement shall specify, among other things: (i) a rolling forecast with binding periods (subject to mutually agreed upon variances); (ii) a binding purchase order requirement with a sufficient lead time for Sutro to incorporate such orders under its then-current contract manufacturing orders with the Manufacturer(s); and (iii) the Product to be supplied Ex Works (Incoterms 2020).

  Section 5.02Manufacture and Supply.

  (a)Notwithstanding anything to the contrary herein, without Sutro’s written consent, Licensee shall not (i) (except following a technology transfer in accordance with Section 5.02(b)) Manufacture or have Manufactured, itself or through an Affiliate or Sublicensee, or authorize or license any Third Party to Manufacture or have Manufactured the Product; (ii) supply any Product it receives from the Manufacturer under this Agreement to any Third Party for any Third Party use, other than Development, compassionate use or patient assistance program and Commercialization of the Product in compliance with this Agreement; or (iii) purchase any Product from any party other than the Manufacturer pursuant to the Supply Agreement.

  (b)After the Effective Date, and within [*] of Licensee’s request, the Parties shall use good faith efforts to enter into a manufacturing technology transfer agreement for the Manufacture of the Product (“Manufacturing Technology Transfer Agreement”). Under such Manufacturing Technology Transfer Agreement, Sutro shall provide to Licensee (i) all the Sutro Know-How, Sutro Manufacturing Information and any other information and documents, as well as tangible materials, including but not limited to [*] (in each case, except to the extent commercially available), in each case to the extent Controlled by Sutro and reasonably necessary for Licensee to exercise the Manufacture License (the “Manufacturing Technology”), and (ii) such technical assistance and support necessary or reasonably useful for Licensee to Manufacture, or have Manufactured by a Third Party contractor engaged by Licensee and reasonably acceptable to Sutro (“Licensee CMO”), the clinical and commercial formulation of the  Product. The transfer of Manufacturing Technology to Licensee shall be free of charge, except that Licensee shall pay Sutro’s costs of the materials described under the foregoing sub-clause (i), and shall further pay Sutro’s FTE costs reasonably incurred in connection with the activities described in the foregoing sub-clause (ii).  The Manufacturing Technology Transfer Agreement shall include terms providing Licensee sufficient rights to use the Manufacturing Technology, which shall not be inconsistent 

  	27	

   

  

  with the terms and conditions in this Agreement. In connection with the execution of the Manufacturing Technology Transfer Agreement, Sutro shall grant Licensee a  royalty-free non-exclusive  license to Manufacture or have Manufactured the Product during the Term, within the Territory, by itself or through an Affiliate or Sublicensee, or authorize or license any Third Party, under Sutro Know-How, Sutro Patents, Sutro Manufacturing Information and any aspect of the Sutro’s Intellectual Property Rights related thereto (the “Manufacture License”). Notwithstanding anything to the contrary, the Manufacture License shall not include any right to access or use any Expression Technology, and Sutro shall have no obligation to deliver to Licensee any Sutro Know-How or Sutro Manufacturing Information related to Expression Technology; provided, however, that Sutro shall provide Licensee with the cell extracts for expressing the protein as set forth in a separate supply agreement (the “Extract Supply Agreement”) under commercially reasonable terms to be separately negotiated by the Parties in good faith (it being understood that the handling fee for supplies sourced from CMOs shall not exceed [*]). [*].

  (c)[*].

  Article 6
CONSIDERATION

  Section 6.01Upfront Payment. As payment for the rights and licenses granted to Licensee by Sutro under this Agreement, Licensee shall pay to Sutro a non-refundable, upfront payment of Forty Million U.S. Dollars (USD $40,000,000.00), which will be paid within the earlier of (i) [*] and (ii) [*], by wire transfer of immediately available funds denominated in U.S. Dollars to an account designated by Sutro.

  Section 6.02Development Milestone.  Upon achievement by or on behalf of Licensee, its Affiliates or its or their Sublicensees of any milestone event set forth in this Section 6.02 (each, a “Development Milestone Event”), Licensee will (a) notify Sutro in writing thereof within [*] following such achievement and (b) pay Sutro each of the milestone payments set forth in the table below (each, a “Development Milestone Payment”), in each case within [*] of such achievement. Licensee shall notify Sutro in writing of the achievement of each such Development Milestone Event promptly after the occurrence thereof as set forth above, except that Sutro shall notify Licensee of the achievement of the Development Milestone Events occurring in the U.S. in accordance with the table below (i.e., [*] and [*], in each case only to the extent provided for in the table below). For purposes of this Section 6.02, “Regulatory Approval” shall be deemed to exclude pricing and reimbursement approvals.

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	Development Milestone Event
	Development Milestone Payment

	Ovarian Cancer

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]

	[*]
	[*]

	[*]
	[*]

	TNBC

	[*]
	[*]

	[*]
	[*]

	Fourth Target Indication (other than the 3 Target Indications set forth above)

	[*]
	[*]

	[*]
	[*]

	Total
	[*]

   

  [*] 

  Section 6.03Sales Milestones.  During the Term, Licensee will notify Sutro in writing of its achievement of each of the sales milestones below  (each, a “Sales Milestone Event”) upon the earlier of (i) within [*] after the publication of Licensee’s audited annual report for the Calendar Year in which the Sales Milestone Event has occurred , and (ii) with [*]  after the end of the first Calendar Quarter following the end of the Calendar Year in which the Sales Milestone Event has occurred. Licensee will pay to Sutro each of the milestone payments set forth below [*] after such notification of achievement and after Licensee receives an invoice therefor from Sutro (each, a 

  	29	

   

  

  “Sales Milestone Payment”). Each of the Sales Milestone Payments for Products set forth in this Section 6.03 is payable only once upon the first achievement of such Sales Milestone Event with respect to all Products, in the aggregate, and none of such Sales Milestone Payments will be payable more than once regardless of how many times such Sales Milestone Event is achieved with respect to all Products, in the aggregate.

  		
	Sales Milestone Event
	Sales Milestone Payment 

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	[*]
	[*]

	Total
	[*]

   

  Sales between Licensee, its Affiliates and Sublicensees shall not be subject to Sales Milestone Payments hereunder. Sales Milestone Payments shall be calculated on Licensee’s, its Affiliates’ and Sublicensees’ sales of the Product to a Third Party.

  Section 6.04Royalties.

  (a)Subject to the remainder of this Section 6.04 and Section 6.05, Licensee shall pay to Sutro a royalty on the Annual Net Sales of the Product in the Territory made by Licensee, its Affiliates, or its Sublicensees at the following rates:

   

  			
	Portion
	Range of Annual Net Sales (USD)
	Royalty Rate

	1
	[*]
	[*]

	2
	[*]
	[*]

	3
	[*]
	[*]

   

  Royalty for a given Calendar Year = [*]

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  For avoidance of doubt, each royalty rate set forth in the table above shall apply only to that portion of the Annual Net Sales in the Territory during a given Calendar Year that falls within the indicated range.

  (b)Sales between Licensee, its Affiliates and Sublicensees shall not be subject to royalties hereunder. Royalties shall be calculated on Licensee’s, its Affiliates’ and Sublicensees’ (re)sale of the Product to a Third Party.

  (c)Royalty Term. The royalty payments payable under this Section 6.04 shall be payable on [*] until the later of, on [*]: (i) the [*]; or (ii) [*] after the First Commercial Sale of the Product in such Region (the “Royalty Term”).  

  (d)Third Party Blocking Patents. 

  (i)Process. In the event either Party becomes aware of one or more Patents Controlled by a Third Party that such Party considers necessary to Develop, Manufacture or Commercialize the Product in the Field in the Territory (each a “Third Party Blocking Patent”), such Party will provide notice thereof to the other Party (“Blocking Patent Notice”), and Sutro will have the first right to obtain a license to the applicable Third Party Blocking Patent(s) from such Third Party. In the event Sutro or any of its Affiliates obtains a license to such Third Party Blocking Patent(s) such that it Controls such Third Party Blocking Patents, such Third Party Blocking Patent(s) will be automatically included in the Sutro Patents, and subject to the Third Party Compensation Reduction (as defined in Section 6.04(d)(ii)), Licensee will be responsible for paying the amounts due under such license in consideration for the practice of such Third Party Blocking Patents under this Agreement, whether by Licensee, its Affiliates or their respective Sublicensees.

  (ii)Third Party Compensation. If Licensee determines that it is necessary to obtain a license to one or more Third Party Blocking Patent(s) from any Third Party and Sutro does not obtain such license within [*] of the date of receipt of the Blocking Patent Notice, Licensee will have the right to obtain a license to such Third Party Blocking Patent(s) from such Third Party. If Licensee is required to pay to Third Party a royalty or other monetary compensation in consideration for the grant of such license or maintenance of the right to Commercialize the Product under such Third Party Blocking Patent(s) (“Third Party Compensation”), then, provided that (i) Sutro has consented in writing to the terms (including, without limitation, the payment terms) of such Third Party license, which shall not be unreasonably withheld, delayed or conditioned; or (ii) subject to the result of (x) settlement procedures or litigation under Section 8.04(c) or (y) other settlements, for the period during which Licensee owes royalties to Sutro hereunder, then the  royalties that would otherwise be payable on Net Sales in the Territory under Section 6.04(a) shall be reduced by an amount of [*] of all Third Party Compensation payable by or on behalf of Licensee to such Third Party during the same period, provided that in no event shall such royalties be reduced by more than [*] of the amounts otherwise payable to Sutro under Section 6.04(a) (such reduction, the “Third Party Compensation Reduction”). 

  (e)Biosimilar Competition. If in a particular Calendar Quarter during the Royalty Term, one or more Third Parties is or are selling a Biosimilar Product in any Region within the Territory and the Net Sales of the Product in such Region during such Calendar Quarter (or any Calendar Quarter thereafter) are less than [*] of the average [*] of the Product  in such Region 

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  over the [*] immediately prior to the Calendar Quarter during which the first such Biosimilar Product was sold in such Region  “Biosimilar Reduction Trigger”), then in such case the royalties payable on the Net Sales of the Product in such Region commencing with such Calendar Quarter in which the Biosimilar Reduction Trigger occurred and thereafter for each Calendar Quarter during the Royalty Term in which such Biosimilar Product is sold in such Region, shall be reduced by [*] of the amounts otherwise payable to Sutro under Section 6.04(a).

  (f)Notwithstanding anything to the contrary under this Agreement, in no event shall the royalties payable to Sutro hereunder by reduced by more than [*] of the amounts set forth in Section 6.04(a).

  Section 6.05Sales by Sublicensees. In the event that Licensee grants sublicenses to one or more Sublicensees to sell Product to the extent permitted hereunder, such sublicenses shall include without limitation an obligation for the Sublicensee to account for and report its Net Sales of such Product on the same basis as if such sales were Net Sales by Licensee, and Licensee shall pay royalties and sales milestones to Sutro as if the Net Sales of the Sublicensee were Net Sales of Licensee.

  Section 6.06Royalty Payments and Reports. The royalties payable under Section 6.04 shall be calculated quarterly as of the last day of March, June, September and December respectively for the Calendar Quarter ending on that date. Licensee shall deliver to Sutro a report summarizing the Net Sales of Product during each Calendar Quarter following the First Commercial Sale of Product in the Territory, which shall include the number of units of Product sold by Licensee, its Affiliates and its or their Sublicensees in each Region, the gross sales of Product on a Region-by-Region and Product-by-Product basis, an itemized calculation of any deductions taken from such gross sales to arrive at Net Sales for the applicable Calendar Quarter and the calculation of the amount of royalty payment due on such Net Sales. A draft of such report shall be provided within [*] following the end of each Calendar Quarter for which royalties are due from Licensee to allow Sutro to estimate its royalty payments from Licensee. A final report shall be delivered within [*] following the end of each Calendar Quarter. Any royalty payable to Sutro or its designee under this Agreement shall be paid with [*] after the end of each Calendar Quarter. The report for the fourth Calendar Quarter shall summarize the Annual Net Sales of Product in such given Calendar Year and shall calculate all the royalties payable to Sutro or its designee for such given Calendar Year pursuant to Section 6.04(a). The royalties to be paid for the fourth Calendar Quarter under this Section 6.06 shall be the difference between the royalties payable and the royalties already paid for such given Calendar Year. If, however, after all the royalty payment due for a given Calendar Year is paid to Sutro, but the Licensee discovers that the Annual Net Sales number reported in the fourth Calendar Quarter report needs to be adjusted in accordance with the Licensee’s audited annual report for such Calendar Year (provided that, for clarity, such report is consistent with the definition of Net Sales under Section 1.62), then Licensee may, subject to prior review and comments by Sutro, adjust and reconcile any such calculation of Annual Net Sales and/or any such underpayment or overpayment of royalty payments due and report such adjustment to Sutro within [*] after the Licensee’s audited annual report is publicly disclosed. Any adjustment and reconciliation of royalty payment for the previous Calendar Year shall be reflected in royalty payment due for the Calendar Quarter in which such adjustment and reconciliation is reported to Sutro, and such adjustment and reconciliation (in the case of an underpayment) shall not be considered a late payment under Section 6.12.     

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  Section 6.07Taxes.

  (a)The royalties, milestones and other amounts payable by Licensee to Sutro pursuant to this Agreement (“Payments”), shall not be reduced on account of Taxes unless required by Applicable Laws. Sutro shall pay [*] Withholding Income Tax up to and including [*]. Licensee shall pay the Withholding Income Tax exceeding [*] up to and including [*]. Any increase beyond [*] shall be paid for [*]. In the event Licensee pays any Withholding Income Tax under the preceding sentences, Licensee shall increase the Payments made so that Sutro receives the same amount after tax (taking into account any Taxes on such increased payments) as it would have received had such Withholding Income Taxes not been incurred.  Licensee is permitted to reduce the amount of Payments to Sutro equal to the amount of the Withholding Income Tax paid by [*]. To the extent any Payments made by Licensee pursuant to this Agreement become subject to Withholding Income Tax under Applicable Laws, Licensee shall deduct and withhold the amount of such Taxes from the Payments due Sutro, but only to the extent that Sutro is required to pay such Taxes under this Agreement. Licensee shall remit the amounts of Withholding Income Tax, whether paid by Sutro or Licensee, to the proper governmental authorities in a timely manner and transmit to Sutro an official tax certificate or other evidence of payment of such tax obligations from the relevant governmental authorities. All taxes or duties in connection with payments made by Licensee for Indirect Taxes, including any value added or similar tax or local tax or surcharge on value added taxes and any import duty or fees, shall be paid by Licensee. Notwithstanding the foregoing, if Sutro is entitled (whether under any applicable tax treaty or otherwise under Applicable Laws) to a reduction in the rate of, or the elimination of, Withholding Income Tax, it may deliver to Licensee or the appropriate governmental authority (with the assistance of Licensee to the extent that this is reasonably required and is expressly requested in writing), the prescribed forms necessary to reduce or eliminate the applicable rate of Withholding Income Tax, and Licensee shall apply the reduced rate of withholding, or dispense with withholding, as applicable. Licensee agrees to take all other reasonable and lawful efforts to minimize such Withholding Income Tax, and Licensee shall cooperate with Sutro as reasonably requested in any claim for refund or application to any Tax Authority. If Licensee intends to withhold income Tax from any Payments, Licensee shall inform Sutro reasonably in advance of making such Payments to permit Sutro an opportunity to provide any forms or information or obtain any Tax Authority approval as may be available to reduce or eliminate such withholding.

  (b)Tax Gross-up. Notwithstanding anything to the contrary herein, if (i) Licensee redomiciles or assigns its rights or obligations under this Agreement, (ii) as a result of such redomiciliation or assignment, Licensee (or its assignee) is required by Applicable Law to withhold taxes from or in respect of any amount payable under this Agreement, and (iii) such withholding taxes (which would include Withholding Income Tax) exceed the amount of withholding taxes that would have been applicable but for such redomiciliation or assignment, then any such amount payable to Sutro pursuant to this Agreement shall be increased to take into account such withholding taxes as may be necessary so that, after making all required withholdings (including withholdings on the additional amounts payable), as the case may be, Sutro 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 pay additional amounts pursuant to the preceding sentence shall not apply, however, to the extent such increased withholding tax would not have been imposed but for the assignment by Sutro of its rights or obligations under this Agreement or the redomiciliation of Sutro outside of the United States, to the extent such 

  	33	

   

  

  assignment or redomiciliation occurs after the redomiciliation or assignment by Licensee described in the first sentence of this Section 6.07(b). Solely for purposes of this Section 6.07(b), a Party’s “domicile” shall include its jurisdiction of incorporation or tax residence and a “redomiciliation” shall include a reincorporation or other action resulting in a change in tax residence of the applicable Party or its assignee.

  (c)Notwithstanding anything to the contrary contained in this Section 6.07 or elsewhere in this Agreement, the following shall apply with respect to Indirect Taxes. If any Indirect Taxes imposed by relevant Regulatory Authorities in the Territory are chargeable in respect of any Payments, Licensee shall be responsible for such Indirect Taxes and shall not reduce any Payments due Sutro hereunder as a result of such Indirect Taxes. The sum of the net amount received by Sutro and the Withholding Income Tax levied by China Tax Authority discussed in Section 6.07(a) above for each payment shall not be less than the amount of the Upfront and Milestone Payments set forth in Section 6.01, Section 6.02 and Section 6.03. The Parties shall issue invoices for all goods and services supplied under this Agreement consistent with Indirect Tax requirements, and to the extent any invoice is not initially issued in an appropriate form, Licensee shall promptly inform Sutro and shall cooperate with Sutro to provide such information or assistance as may be necessary to enable the issuance of such invoice consistent with Indirect Tax requirements.

  Section 6.08Payments or Reports by Affiliates. Any Payment required under any provision of this Agreement to be made to Sutro or any report required to be made by Licensee shall be made by an Affiliate of Licensee if such Affiliate is designated by Licensee as the appropriate payer or reporting entity.

  Section 6.09Mode of Payment. All payments set forth in this Article 6 shall be remitted by wire transfer to the bank account of Sutro as designated in writing to Licensee.

  Section 6.10Payment Currency. All amounts payable and calculations under this Agreement shall be in U.S. Dollars. As applicable, Net Sales and any adjustments to payments under this Agreement shall be translated into United States dollars using the average of the applicable daily foreign exchange rates published in The Wall Street Journal (or any other qualified source that is acceptable to both Parties) for the last day of each month of the Calendar Quarter in which such Net Sales occurred. 

  Section 6.11Imports. For the avoidance of doubt, the Parties acknowledge and agree that none of the milestones or royalties payable under this Agreement are related to the license (or right) to import or any import of the Product. Licensee shall be responsible for any import clearance, including payment of any import duties and similar charges, in connection with the Product transferred to Licensee under this Agreement. The Parties shall co- operate in accordance with Applicable Laws to ensure where permissible that no import duties are paid on imported materials. Where import duties are payable, the Parties shall co-operate to ensure that the Party responsible for shipping values the materials in accordance with Applicable Laws and minimizes where permissible any such duties and any related import taxes that are not reclaimable from the relevant authorities.

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  Section 6.12Late Payments. Any payments due under this Agreement shall be due on such date as specified in this Agreement and, in the event such date is not a Business Day, then the next succeeding Business Day. In the event that any payment due under this Agreement is not made when due, the amount due shall accrue interest beginning on the [*] following the date on which such payment was due, calculated at the annual rate equal to the prime interest rate reported in the Wall Street Journal for the due date plus [*], calculated from the due date until paid in full. Each payment made after the due date shall be accompanied by all interest so accrued. Notwithstanding the foregoing, a Party shall have recourse to any other remedy available at law or in equity with respect to any delinquent payment, subject to the terms of this Agreement.

  Article 7
CONFIDENTIALITY

  Section 7.01Confidentiality. The Parties agree that the Party receiving Confidential Information disclosed by or on behalf of the other Party pursuant to this Agreement is entitled to disclose Confidential Information to its Affiliates, Sublicensees (in the case of Licensee), licensees (in the case of Sutro), contractors, their respective officers, directors, employees, agents, counsels, accountants,  other advisors and consultants, only for the purpose of the Agreement on a need-to-know basis, and shall cause the aforesaid persons to keep confidential and not publish or otherwise disclose or use for any purpose other than to conduct its activities under this Agreement or otherwise as expressly authorized by this Agreement any Confidential Information furnished to it by or on behalf of the other Party pursuant to this Agreement.

  Section 7.02Exceptions. Notwithstanding the foregoing, the obligations set forth in Section 7.01 shall not apply in respect of Confidential Information to the extent that it can be established by the receiving Party that such Confidential Information:

  (a)was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by or on behalf of the other Party;

  (b)was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

  (c)was independently developed without use of the disclosing Party’s information, as evidenced by contemporaneous written records;

  (d)became generally available to the public or otherwise part of the public domain after its disclosure to the receiving Party and other than through any act or omission of the receiving Party in breach of this Agreement; or

  (e)was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others.

  Section 7.03Receipt of Third Party Information. Neither Party shall knowingly receive documents relating to the Product under an obligation of confidentiality to Third Parties that requires the Party to withhold access to the other Party without such Party’s written consent.

  	35	

   

  

  Section 7.04Authorized Disclosure. The receiving Party may disclose Confidential Information of the disclosing Party to a Third Party only upon reasonable advanced notice to the disclosing Party and only to the extent that such disclosure is:

  (a)required by law, order, or regulation of a government agency or a court of competent jurisdiction, or by the rules of a securities exchange, provided that the receiving Party required to make such disclosure shall, after providing reasonable advanced notice to the disclosing Party before the disclosure, (i) give the disclosing Party an opportunity to comment on any such required disclosure, (ii) if requested by the disclosing Party, use Commercially Reasonable Efforts to obtain protective orders or any available limitations on or exemptions from such disclosure requirement where applicable and practicable;

  (b)made to a patent office for the purposes of filing or enforcing a Patent as permitted in this Agreement, provided, however, the receiving Party (i) receives written consent from the disclosing Party for such disclosure, and (ii) takes reasonable measures to assure confidential treatment of such information, to the extent such protection is available;

  (c)made by a Party or its Affiliates, or Sublicensees to the Regulatory Health Authority for the purposes of any filing, application or request for Regulatory Approval for the Product as permitted in this Agreement;

  (d)made to advisors, actual or potential Third Party partners, investors, licensees, sublicensees or acquirers of all or substantially all of the assets to which this Agreement relates, solely in connection with due diligence activities; provided, however, the receiving Party takes reasonable measures to assure confidential treatment of such information, to the extent such protection is available;

  (e)made by Licensee or its Affiliates, or Sublicensees to Third Parties as may be necessary or useful in connection with the Exploitation and Manufacturing of the Product as contemplated by this Agreement, including subcontracting or sublicensing transactions permitted hereunder in connection therewith; provided that the Party making such disclosures shall ensure that each Third Party recipient is bound by obligations of confidentiality no less restrictive than those contained in this Agreement and shall be liable to the other Party for any breach of such confidentiality obligations by the relevant recipient.

  Section 7.05Survival. This Article 7 (other than Section 7.03) shall survive for a period of five (5) years following the termination or expiration of the Agreement, provided however, that all Trade Secret information shall be safeguarded by the receiving Party as required by this Agreement in perpetuity or for so long as such information remains a Trade Secret under Applicable Law.

  Section 7.06Termination of Prior Agreements. This Agreement supersedes the Confidentiality Agreement between Sutro and Licensee dated as of June 10, 2021 (the “CDA”). All Information and Materials exchanged between the Parties under the CDA shall be deemed Confidential Information and shall be subject to the terms of this Article 7.

  Section 7.07Publications. Except as required by law, Licensee agrees that it shall not publish or publicly present any scientific, technical, or academic information relating to the Product (a) without the prior written consent of Sutro and (b) other than in compliance with this 

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  Section 7.07. For the avoidance of doubt, advertising information shall be subject to this Section 7.07 if it is not in accordance with the approved label or published academic papers. Licensee shall provide to Sutro the opportunity to review any proposed publications, presentations, meeting abstracts, talks or other publicity (including without limitation information to be presented verbally) that relate to the Product as early as reasonably practical, but at least [*] prior to their intended submission for publication or presentation, and Licensee agrees, upon written request from Sutro within the Review Period (as defined below), not to submit such abstract, manuscript, or other publicity materials for publication or to make such presentation until Sutro agrees, which agreement by Sutro shall not be unreasonably withheld. Sutro shall have [*] after its receipt of any such publication or presentation (the “Review Period”) to notify Licensee in writing of any specific objections to the intended publication or presentation. Licensee shall, in any such publication or presentation, delete from the proposed disclosure any Confidential Information of Sutro. Additionally, if Sutro notifies Licensee within the Review Period that it objects to such disclosure on the basis that a patent application claiming information contained in such disclosure should be filed prior to such disclosure, Licensee agrees to reasonably delay disclosure of the relevant information, for up to [*] after Sutro’s timely notification of its objection as per the above, or until such application has been filed, if earlier. Once any such abstract or manuscript is accepted for publication, Licensee will provide Sutro with a copy of the final version of the manuscript or abstract.

  Article 8
OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS

  Section 8.01Ownership. Except as expressly provided in this Agreement, Sutro shall retain sole and exclusive Control of the Sutro Technology, including Sutro Know-How, Sutro Patents, and Sutro Trademarks. Except as expressly provided herein, no right, title, or interest is granted by Sutro to Licensee in, to, or under any Sutro Technology, and, except as expressly provided herein, Licensee shall have no right to assign to any Third Party any right or interest received under Sutro Technology under the terms of this Agreement. Licensee shall retain sole and exclusive Control of any Licensee Technology.

  Section 8.02License of Product-related IPR. Licensee hereby grants to Sutro a royalty-free, fully paid-up, perpetual, non-terminable, sublicenseable (through multiple tiers) license to use any Product-related IPR that Licensee or its Affiliates or Sublicensees may create or acquire throughout the Term of this Agreement, which license shall be non-exclusive in the Territory and exclusive (including as to Licensee and its Affiliates) outside of the Territory; provided, however, that the license granted to Sutro by Licensee under this Section 8.02 in the Territory is limited to the use of Product-related IPR  by Sutro in conducting clinical or manufacturing activities in the Territory for the purpose of Development and Commercialization of the Product outside the Territory. Licensee shall be responsible for ensuring its employees, Affiliates, and Sublicensees are obligated to license and execute appropriate documents consistent with Licensee’s obligations under this Section 8.02.  

  Section 8.03Prosecution and Maintenance of Patents.

  (a)Sutro shall be primarily responsible for and control the preparation, filing, prosecution, and maintenance of the Sutro Patents in the Territory. Sutro shall, at its own cost, file, 

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  prosecute, and maintain all Sutro Patents in the Territory after taking into account Licensee’s reasonable interests and requests after reasonable consultation with Licensee. Sutro shall provide Licensee with advance copies of, and a reasonable opportunity to comment upon, proposed patent filings, related prosecution strategies and proposed correspondence with patent officials, all to the extent in the Territory and relating to any Sutro Patents, and will consider comments received from Licensee with respect to such proposed filings, strategies and correspondence in the Territory in good faith. Sutro agrees to discuss in good faith any changes reasonably requested by Licensee to such filings, strategies and correspondence in the Territory upon their being received. As relevant to the activities and interests of Licensee under this Agreement, Sutro shall promptly inform Licensee in writing of any change in the status of the Sutro Patents in the Territory.

  (b)If, during the Term, Sutro decides that it is no longer interested in the prosecution or maintenance of a particular Sutro Patent in the Territory, then, unless Sutro has a strategic rationale for ceasing such prosecution or maintenance, it will provide written notice to Licensee of such decision at least [*] prior to the date that such Sutro Patent will become abandoned.  Licensee may, upon written notice to Sutro, cause Sutro not to cease the prosecution or maintenance of any such Sutro Patent with respect to which Sutro does not have a strategic rationale for the abandonment thereof.  

  Section 8.04Enforcement Rights.

  (a)Infringement by Third Parties in the Territory. Sutro shall have the initial right, but not the obligation, at its expense and in its own name or in the name of any of its Affiliates, to initiate, maintain, and control any legal action on account of any infringement within the Territory of any Sutro Patent or Sutro Trademark by a Third Party, by counsel of its own choice. Sutro shall promptly notify Licensee in writing its intention to initiate legal action against a Third Party for such infringement within the Territory. If Sutro exercises its first right, Licensee will, at Sutro’s expense, provide Sutro cooperation as reasonably necessary, including being named as a party. With respect to actions, proceedings or settlements in the Territory, Licensee shall have the right, in Licensee’s sole discretion and at Licensee’s expense, to join or otherwise participate in such legal action in the Territory with legal counsel selected by Licensee. If Sutro does not intend to exercise its first right, then Sutro shall so notify Licensee in writing within [*] of receiving notice or otherwise becoming aware that the applicable infringement exists. Licensee will thereafter have the right, but not the obligation, at its expense and in its own name or in the name of any of its Affiliates, to initiate, maintain, and control such legal action on Sutro’s behalf by counsel of its choice. In the event that Licensee initiates and thereafter maintains such legal action against a Third Party for infringement of a Sutro Patent or Sutro Trademark in the Territory, Sutro, at Licensee’s expense, will provide Licensee cooperation as reasonably necessary, including agreeing to be named as a party to such legal action.

  (b)The Party first having Knowledge that any Sutro Technology is infringed, or misappropriated by a Third Party, or suspected of being infringed or misappropriated by a Third Party in the Territory shall promptly notify the other Party thereof in writing. Such notice shall set forth the facts of that infringement, misappropriation, or suspected infringement or misappropriation in reasonable detail.

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  (c)Allocation of Expenses and Recoveries. Except as otherwise agreed by the Parties in this Agreement or otherwise in writing, the Party controlling the legal action under Section 8.04 (a) shall be solely responsible for any expenses incurred by such Party as a result of such action. If the Parties are recovered monetary damages in such action, such amounts shall be allocated first to the reimbursement of any expenses incurred by the Parties in such action, and any remaining amounts shall be [*] between the Parties, provided that if Licensee is the enforcing Party, then such remaining amounts will be treated as Net Sales in the period in which payment of such recovery was received for purposes of the royalty obligations under Section 6.04. If such recovery is insufficient to reimburse the expenses of the Parties, then each Party shall receive a pro rata portion of the recovery based on each Party’s expenses incurred in such action. 

  (d)Oppositions by Parties. If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, reexamination, or other attack upon the validity, title, or enforceability of any Patents Controlled by a Third Party in the Territory that claim the Development or Commercialization or other exploitation of the Product, such Party shall so notify the other Party in writing, and the Parties shall promptly confer to discuss whether to bring such action or the manner in which to settle such action; provided, if the Parties cannot reach agreement on whether to bring such action within [*] of such written notice, then such issue shall be subject to the dispute resolution procedures of Article 13. The Party not bringing an action under this Section 8.04(d) shall be entitled to separate representation in such proceeding by counsel of its own choice and at its own expense, and shall otherwise cooperate fully with the Party bringing such action at the other Party’s expense.

   

  Section 8.05Third Party Claims Against Product in the Territory. 

  (a)If a Third Party asserts that a Patent or other right owned or controlled by it is infringed by the Development, Manufacture or Commercialization of the Product in the Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties shall promptly confer to consider the claim or assertion and the appropriate course of action. Unless the Parties otherwise agree in writing, each Party shall have the right to defend itself against a suit that names it as a defendant (the "Defending Party"), provided that (i) neither Party shall enter into any settlement of any claim described in this Section 8.05(a) or make any admissions or assert any positions in such defense proceeding in a manner that could  reasonably be expected to adversely affect the rights or interests of the other Party, including with respect to the Product or the Development, Manufacture, or Commercialization of the Product within the other Party's territory, without the prior written consent of the other Party, and (ii) Licensee may not enforce any Sutro Patent in connection with such suit without Sutro’s consent, not to be unreasonably withheld, conditioned or delayed. In any event, the other Party shall reasonably assist the Defending Party and cooperate in any such litigation at the Defending Party's reasonable request and expense.  

  If as a result of settlement procedures or litigation under this Section 8.05(a), Licensee is required to pay the Third Party a royalty or make any payment of any kind for the right to sell the Product in the Territory, such payments shall be considered Third Party Compensation under Section 

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  6.04(d) and Licensee may deduct such Third Party Compensation from its royalty payment obligations to Sutro in accordance with Section 6.04(d).

  (b)Oppositions by Third Parties. If any Sutro Patent in the Territory becomes the subject of any proceeding commenced by a Third Party in connection with an opposition, reexamination request, action for declaratory judgment, nullity action, third party observation interference, or other attack upon the validity, title, or enforceability thereof in the Territory, then Sutro shall control such defense, at its sole cost, provided that, Licensee shall have the right to participate in the proceeding to the extent permissible under law, and to be represented by its own counsel in such proceeding, at its sole cost. Licensee shall reasonably cooperate with Sutro in such proceeding. Any recoveries obtained in such action shall be shared, as set forth in Section 8.04(c).

  (c)Protective Order. If, in any action brought pursuant to Section 8.04 and this Section 8.05 any information is the subject of a protective order that may be reviewed by counsel only, the Parties will endeavor to structure such protective order so as to enable their respective internal counsel to be included as permitted reviewers of such information.

  Article 9
REPRESENTATIONS, WARRANTIES, AND COVENANTS

  Section 9.01Representations, Warranties, and Covenants.

  (a)Each of the Parties hereby represents and warrants to the other Party that:

  (i)It is a corporation or limited company duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and it has the full right, power and authority to enter into this Agreement and to perform its obligations hereunder.

  (ii) All consents, approvals, and authorizations from all Regulatory Authorities or other Third Parties required to be obtained by such Party to execute this Agreement have been obtained.    

  (iii)This Agreement has been duly executed by it and is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any Applicable Law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it. 

  (b)Sutro represents, warrants and covenants as of the Effective Date (or as of such other/additional time as may be explicitly specified below) to Licensee that:  

  (i)Sutro Controls the Sutro Technology, and has the right to grant to Licensee the licenses that it purports to grant hereunder.

  (ii)  Sutro has not granted, and shall not grant during the Term, to any Third Party any rights would be in conflict with the rights granted to Licensee under this Agreement.

  (iii)Sutro is the sole and exclusive owner of the entire right, title and interest in the Sutro Patents. All Sutro Patents as of the Effective Date are listed in Exhibit A. To Sutro’s 

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  knowledge, the Sutro Patents are (a) subsisting and in good standing and (b) being diligently prosecuted in the respective patent offices in accordance with Applicable Laws, and have been filed and maintained properly and correctly. 

  (iv)To Sutro’s Knowledge, the Sutro Know-How has not infringed and, if used in accordance with this Agreement, will not infringe any Intellectual Property Rights of any Third Party in the Territory.

  (v)To Sutro’s Knowledge, all applicable fees due to patent authorities with respect to the filing and prosecution of the Sutro Patents existing as of the Effective Date have been paid on or before the due date for payment (as such due date may be extended in accordance with Applicable Law or patent authority rules and regulations) and will be paid in time during the Term.

  (vi)As of the Effective Date, to Sutro’s Knowledge, there is no actual or threatened infringement or misappropriation of the Sutro Technology in the Territory by any Person.

  (vii)There is no action, suit, inquiry, investigation or other proceeding threatened, pending, or ongoing by any Third Party that challenges or threatens the validity, enforceability or Sutro’s Control of any of the Sutro Patents or Sutro Trademarks in the Territory. In the event that Sutro receives notice of any such action or proceeding, it shall notify Licensee promptly in writing.

  (viii)There is no pending or, to its knowledge, threatened, litigation or arbitration which alleges, or any written communication alleging, that Sutro’s activities with respect to the Sutro Know-How or the Licensed Compound have infringed or misappropriated any of the Intellectual Property Rights of any Third Party.

  (ix)Sutro has not been debarred by the FDA, is not subject to any similar sanction of other Regulatory Health Authorities in the Territory, and is not subject to any such debarment or similar sanction    by any such Regulatory Health Authority, and Sutro has not used, and will not engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Health Authority, or is the subject of a conviction described in Section 306 of the FFDCA (21 U.S.C. §335a). Sutro shall inform Licensee in writing immediately if it or any Person engaged by Sutro who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA (21 U.S.C. §335a) or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Sutro’s Knowledge, is threatened, relating to the debarment or conviction of Sutro or any such Person performing services hereunder.

  (x)Sutro shall perform its obligations and responsibilities under this Agreement in compliance with this Agreement, all Applicable Laws, applicable FDA (or foreign equivalent) requirements, including, to the extent applicable, then-current GLP and GCP.

  (xi)To Sutro’s knowledge (after reasonable inquiry) Sutro has disclosed or made available to Licensee for review all Sutro Development Data, Regulatory Documentation, and other material information relating to the safety and efficacy of the Licensed Compound, and all such information is complete and accurate in all material respects. 

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  (xii)To Sutro’s knowledge (after reasonable inquiry), the Licensed Compound and the cell extracts under the Extract Supply Agreement, as well as the Sutro Technology and Sutro’s Intellectual Property Rights related to the Manufacture License, do not require a license or other authorization for export to the Territory under any Export Controls and Economic Sanctions Laws. Sutro agrees that if such a license or other authorization is required anytime during the Term, Sutro shall use Commercially Reasonable Efforts to obtain such license or authorization.

  (xiii)Other than the Upstream Agreement, there is no agreement between Sutro or its Affiliates with any other Third Party pursuant to which Licensor or any of its Affiliates obtains any license to Sutro Technology. Sutro has achieved all the milestones specified in the Upstream Agreement on schedule and Sutro and its Affiliates are in material compliance with the Upstream Agreement.

  (xiv)Sutro shall maintain the Upstream Agreement in full force and effect and shall not terminate, amend, waive or otherwise modify (or consent to any of the foregoing) its rights under the Upstream Agreement in any manner that diminishes the rights or licenses granted to Licensee or increases or generates any new obligation (including any payment obligation) under the Upstream Agreement that would apply to Licensee, without Licensee’s express written consent.

  (xv)Within [*] after the Effective Date, Sutro shall enter into an agreement with [*] whereby (i) Sutro would agree to fund the development of the CDx, (ii) [*] would agree to obtain any necessary regulatory approvals and commercialize the CDx in the Territory, whether on its own or through its Affiliates or one or more designated Third Party(ies), provided that any associated costs that are specific to the Territory will be borne by Licensee. Sutro acknowledges that the failure to comply with this Section 9.01(b)(xiv) shall constitute a material breach of this Agreement and Licensee shall have the right to terminate this Agreement in accordance with Section 11.02(a).

   

  (c)Licensee represents, warrants and covenants as of the Effective Date (or as of such other/additional time as may be explicitly specified below) to Sutro that:

  (i)Licensee has not been debarred by the FDA (and is not subject to any similar sanction of other Regulatory Health Authorities in the Territory), and is not subject to any such debarment or similar sanction by any such Regulatory Health Authority, and Licensee has not used, and will not engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Health Authority, or is the subject of a conviction described in Section 306 of the FFDCA (21 U.S.C. §335a). Licensee shall inform Sutro in writing immediately if it or any Person engaged by Licensee who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA (21 U.S.C. §335a), or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Licensee’s Knowledge, is threatened, relating to the debarment or conviction of Licensee or any such Person performing services hereunder.

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  (ii)To the extent permissible under Applicable Laws, each employee and contractor of Licensee performing obligations under this Agreement  shall  be required to, prior to conducting any such obligations hereunder, be obligated by Applicable Law, or written contract, to (i) promptly disclose to Licensee of all inventions and Know-How conceived or reduced to practice by such employee or contractor during any performance under this Agreement, (ii) automatically assign to Licensee all right, title and interest in and to all such inventions and Know-How and all Intellectual Property Rights therein, including all Product-related IPR and Product-related data, and (iii) adhere to obligations of confidentiality at least as stringent as those set forth in this Agreement. 

  (iii)Licensee shall perform, or cause its Affiliates or Sublicensee to perform, its obligations and responsibilities under this Agreement in compliance with this Agreement, all Applicable Laws, applicable NMPA (or foreign equivalent) requirements, including, without limitation, then-current GLP and GCP.

  (iv)	Licensee affirms that it is not subject to sanctions or export restrictions under Export Controls and Economic Sanctions Laws that would require U.S. government authorization for it to receive any U.S. origin services, goods, software, or technology, and it further affirms that its use, transfer, or re-export of the Licensed Compound and the cell extracts under the Extract Supply Agreement will comply with Export Controls and Economic Sanctions Laws.

  Section 9.02No Debarment. In the course of the Development of the Product in the Territory in accordance with this Agreement and during the term of this Agreement, neither Party will use, any employee or consultant that is debarred by any Regulatory Health Authority or, to the best of such Party’s Knowledge, is the subject of debarment proceedings by any Regulatory Health Authority. If either Party learns that its employee or consultant performing on behalf under this Agreement has been debarred by any Regulatory Health Authority, or has become the subject of debarment proceedings by any Regulatory Health Authority, such Party shall so promptly notify the other Party and shall prohibit such employee or consultant from performing on its behalf under this Agreement. The foregoing shall be without prejudice to the warranties stipulated in Section 9.01(b)(iv).

  Section 9.03Privacy, Anti-Bribery, and Anti-Corruption Compliance.

  (a)Compliance with Privacy Laws. Each Party shall implement appropriate processes and controls with respect to technology and workflow methodologies in connection with its activities under or in connection with this Agreement so as to protect the security and privacy of personally identifiable information exchanged under this Agreement in accordance with Applicable Law.

  (b)Compliance with Applicable Anti-Corruption Laws. Each party understands and agrees that it has complied and will continue to comply with all applicable Anti-Corruption Laws in connection with this Agreement.

  (i)Each Party represents and warrants that no payments of money or anything of value have been or will be offered, promised, or paid, whether directly or indirectly, by any of 

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  its directors, officers, employees, Affiliates, or third party representatives to any Government Official in connection with this Agreement: (a) to influence any official act or decision of any Government Official; (b) to induce any Government Official to do or omit to do any act in violation of lawful duty; (c) to secure any improper business advantage; or (d) to obtain or retain business for, or otherwise direct business to, any Party in connection with this Agreement.

  (ii)Each Party warrants and represents that, in connection with this Agreement, such Party, its directors, officers, employees, and third party representatives: (a) have not and will not request, accept, offer, promise, or give any bribe, kickback, or other corrupt payment to any person, including any representative of any commercial entity, in violation of any applicable Anti-Corruption Law; and (b) have not and will not request, offer, promise, or give any financial or other advantage to induce another person to perform a function or activity in order to obtain or retain an improper business advantage in any way relating to this Agreement.

  (iii)Each Party warrants and represents that (a) it does not have any interest which directly or indirectly conflicts with its proper and ethical performance of the Agreement, and (b) it shall maintain arms-length relations with all Third Parties with which it deals for or on behalf of the other party in performance of the Agreement.

  (c)Notification of Investigations into Potential Non-Compliance with Applicable Anti-Corruption Laws. Each Party warrants and represents that it will promptly inform the other party if such party, or any of its directors, officers, employees, Affiliates, third party representatives, or Sublicensees becomes subject to any investigation relating to any actual or potential violation of any applicable Anti-Corruption Law in connection with this Agreement, including any meeting, interview, inspection, or audit requested by any Regulatory Authority.

  (d)Cooperation with Due Diligence and Investigations. Each Party will provide reasonable cooperation in connection with any good faith investigation conducted by the other party into potential violations of applicable Anti-Corruption Laws in connection with this Agreement.

  (e)Compliance Program. Each Party will adopt, implement, and/or update and, throughout the course of this Agreement, have, maintain, and enforce an appropriate and risk‐based anti-corruption compliance program designed to reasonably ensure compliance with the representations contained in this Section 9.03 of the Agreement and all applicable Anti-Corruption Laws.

  (f)Periodic Compliance Certifications. On an [*] basis following the execution of this Agreement, or as reasonably requested in good faith by the other Party, each Party agrees to submit a compliance certificate to the other Party which restates the representations and warranties that are set forth in this Section 9.03 and provides certification by such Party that it has adhered, during the period covered by the compliance certificate, to the representations and warranties.

  Article 10
RECORD RETENTION, AUDIT AND USE OF NAME

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  Section 10.01Records Retention; Audit.

  (a)Each Party shall keep or cause to be kept accurate records of account in accordance with P.R.C GAAP, in the case of Licensee, and in accordance with U.S. GAAP, in the case of Sutro, showing information that is necessary for the accurate determination of (in the case of Licensee) the royalties and other payments due under Article 6, or any other payment due hereunder and (b) (in the case of Sutro) the applicable Cost of Goods,. Such records or books of account shall be kept until the [*] in which the relevant Product is sold (in the case of royalty or other payments due under Section 6.04) or in the period for which any other payment hereunder is required to be made. For clarity, Licensee shall cause its Affiliates to keep, and shall require pursuant to a written agreement that any Sublicensee or subcontractor performing activities hereunder keep accurate records or books of account in a manner that will permit such Party to comply with its obligations under the foregoing sentence.

  (b)Upon the written request of the other Party, each Party shall permit an internationally-recognized, certified public accounting firm acceptable to both Parties to inspect during regular business hours and no more than once a year and once in any given Calendar Year, and going back no more than [*] preceding the current Calendar Year, all or any part of the audited Party’s records and books necessary to check the accuracy of any Cost of Goods calculated or payments made or required to be made hereunder. The accounting firm shall enter into appropriate obligations with the audited Party to treat all information it receives during its inspection in confidence. The accounting firm shall disclose to Sutro and Licensee only whether Cost of Goods calculated or the payments made are correct and details concerning any discrepancies, but no other information shall be disclosed to the Party requesting the inspection. The charges of the accounting firm shall be paid by the Party requesting the inspection, except that if the Cost of Goods being audited have been overcalculated, or the payments being audited have been underpaid or the costs being reimbursed have been overstated, in each case by more than [*], the charges will be paid by the Party whose records and books are being inspected. If the final result of the audit reveals an undisputed underpayment or overpayment, (i) Licensee shall pay to Sutro any underpayment discovered by such audit within [*] after the accounting firm’s report,  and the part of underpayment that is within [*] of the original payment amount due shall not be considered a late payment under Section 6.12, (ii) in the case of an overpayment by Licensee, then  Licensee may take a credit for such overpayment against any future payments due to Sutro, or if no future payments are due to Sutro then Sutro shall pay to Licensee any overpayment discovered by such audit within [*] after the accounting firm’s report. Any failure by a Party to exercise its rights under this Section 10.01 with respect to a Calendar Year within the [*] period allotted therefor shall constitute a waiver by such Party of its right to later object to any payments made by the other Party under this Agreement during such Calendar Year. 

  Section 10.02Publicity Review. Subject to the further provisions of this Section 10.02, no Party shall originate any written publicity, news release, or other announcement relating to this Agreement or to performance hereunder or the existence of an arrangement between the Parties (collectively, “Written Disclosure”), without the prior prompt review of a copy of the materials proposed to be disclosed and written approval of the other Party. This Section 10.02, shall not prohibit the disclosure under Section 7.04(a). Notwithstanding the foregoing provisions of this Section 10.02, each Party may make any public Written Disclosure it believes in good faith based upon the advice of counsel is required under the Securities Laws of the United States, Hong Kong 

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  SAR or P. R. China, or any listing or trading agreement concerning its publicly traded securities, or under any applicable securities laws, or any rule or order of stock exchange; provided that, prior to making such Written Disclosure, Sutro or Licensee shall, where reasonably practicable and legally permitted, provide the other Party with a copy of the materials proposed to be disclosed and an opportunity to promptly review and comment on the proposed Written Disclosure. To the extent that Licensee reasonably requests that any information in the materials proposed to be disclosed be deleted, Sutro shall use reasonable efforts to request confidential treatment of such information pursuant to Rule 406 of the Securities Act of 1933 or Rule 24b-2 of the Securities Exchange Act of 1934, as applicable (or any other applicable regulation relating to the confidential treatment of information) so that any information that Licensee reasonably requests to be deleted, to the extent permitted by the applicable government agency, are omitted from such materials. Notwithstanding the foregoing, each Party may issue an individual press release regarding the transaction contemplated by this Agreement, subject to the other Party’s right to review and comment such press release prior to publication. For clarity, Sutro shall have the right to issue press releases and other public announcements regarding the Development or Commercialization of the Product outside of the Territory without the prior review or written approval of Licensee.

  Section 10.03Use of Names. Neither Party shall use the name, insignia, symbol, trademark, trade name or logotype of the other Party or its Affiliates in relation to this transaction or otherwise in any public announcement, press release, or other public document without the prior written consent of such other Party; provided, however, that either Party may use the name of the other Party in any document required to be filed with any government authority, including without limitation the FDA and the Securities and Exchange Commission, or foreign equivalent bodies, or otherwise as may be required by Applicable Law, provided that such disclosure shall be governed by Section 7.04. Further, the restrictions imposed on each Party under this Section 10.03 are not intended, and shall not be construed, to prohibit a Party from identifying the other Party in its internal business communications, provided that any Confidential Information in such communications remains subject to Article 7.

  Article 11
TERM AND TERMINATION

  Section 11.01Term. The term of this Agreement shall commence as of the Effective Date and, unless sooner terminated as provided herein, shall continue in effect until the expiration of the Royalty Term, on a Region-by-Region basis (the “Term”).On a Region-by-Region basis, following the expiration (but not early termination) of the Term in the applicable Region, the licenses granted to Licensee under this Agreement (including the Manufacture License) shall become exclusive, fully-paid, royalty-free, perpetual and irrevocable with respect to such Region, and the sales of the Product in such Region shall not be included in the calculation of Net Sales.  

  Section 11.02Termination Rights.

  (a)Termination for Cause.  This Agreement may be terminated in its entirety at any time during the Term upon written notice by either Party (the “Non-Breaching Party”) if the other Party (the “Breaching Party”) is in material breach of this Agreement and, in each case, has not cured such breach within [*] after notice requesting cure of the breach. Notwithstanding the foregoing, in the event there is a good faith dispute as to whether a material breach exists, the 

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  dispute shall be resolved pursuant to Section 13.02, in which case if (a) the Breaching Party is determined in accordance with Section 13.02 to be in material breach of one (1) or more of its obligations under this Agreement, and (b) the Breaching Party fails to complete the actions specified by such adverse ruling to cure such material breach in accordance with any procedures or timeframes established by the tribunal, then the Non-Breaching Party may terminate this Agreement upon written notice to the Breaching Party.  . During the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.

  (b)Termination for Challenge of Sutro Patents. Prior to its expiration, Sutro may terminate this Agreement in its entirety by written notice to Licensee if (i) Licensee or its Affiliates challenges the validity, scope or enforceability of or otherwise opposes any Sutro Patent inside or outside the Territory and (ii) Licensee does not cause such challenge to be withdrawn within [*] after having received written notice thereof from Sutro requesting such challenge to be withdrawn. If a Sublicensee challenges the validity, scope, or enforceability of or otherwise opposes any Sutro Patent inside or outside of the Territory, then Licensee shall, upon written notice from Sutro, terminate such sublicense or cause the Sublicensee to withdraw such challenge within [*]. Licensee shall include provisions in all agreements under which a Sublicensee obtains a sublicense under any Sutro Patent providing that, if the Sublicensee challenges the validity, scope or enforceability of or otherwise opposes any Sutro Patent inside or outside the Territory, Licensee may terminate such sublicense. 

  (c)Termination for Insolvency. A Party may terminate this Agreement effective immediately upon written notice to the other Party if at any time during the Term, the other Party (the “Debtor”) (i) becomes insolvent, (ii) has a case commenced by or against it under the Bankruptcy Code, (iii) files for or is subject to the institution of bankruptcy, liquidation or receivership proceedings, (iv) assigns all or a substantial portion of its assets for the benefit of creditors, (v) has a receiver or custodian appointed for the Debtor’s business, or (vi) has a substantial part of its business being subject to attachment or similar process; provided, however, that in the event of any involuntary case under the Bankruptcy Code, the first Party shall not be entitled to terminate this Agreement pursuant to this Section 11.02(c) if the case is dismissed within [*] after the commencement thereof.

  (d)Termination for Convenience. Prior to its expiration, this Agreement may be terminated in its entirety at any time by Licensee effective upon ninety (90) days’ (or such longer period as Licensee may elect at its sole discretion) prior written notice to Sutro.

  (e)Termination for Safety/Efficacy Issue. In the event that Licensee believes in good faith a Safety/Efficacy Issue exists, as a result of which a company in the biopharmaceutical industry in the Territory would reasonably be expected to elect not to continue to fund or conduct the development or commercialization of the Product,  Licensee may terminate this Agreement in its entirety or in part with respect to the affected Product upon [*] (or such longer period as Licensee may elect at its sole discretion) prior written notice to Sutro.

  Section 11.03Consequences of a Licensee Triggered Termination. In the event (a) Sutro terminates this Agreement pursuant to Section 11.02(a) for Licensee’s material breach; (b) Sutro terminates this Agreement pursuant to Section 11.02(b) for patent challenge by Licensee; 

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  (c) Sutro terminates this Agreement pursuant to Section 11.02(c) for Licensee’s insolvency; or (d) Licensee terminates this Agreement pursuant to Sections 11.02(d), or 11.02(e) (a termination as per (a) through (e) being a “Licensee Triggered Termination”), both Sutro and Licensee shall, subject to Section 11.03(a), continue to be obligated during the termination notice period (as applicable) to perform as far as reasonably practicable all of its obligations under this Agreement and any other agreements concluded between the Parties in accordance with this Agreement. In addition, as a result of a Licensee Triggered Termination the following shall apply (without prejudice to the terminating party’s other rights and remedies at law or in equity):

  (a)All licenses and rights to the Sutro Technology granted to Licensee (together with all sublicenses granted by Licensee) hereunder shall terminate automatically without further action required on the part of Sutro as of the effective date of such termination, except to the extent and for so long as is necessary to permit Licensee to finish work-in-progress, sell any inventory of Product that remains on hand as of the date of the termination and otherwise perform any responsibilities in connection with any then ongoing clinical trial or other activity that cannot be terminated as of such date under Applicable Laws, including GCP, it being agreed that all such activities and responsibilities shall be discontinued and ceased (unless otherwise agreed or required under Applicable Laws by transitioning such activities and responsibilities to Sutro) as promptly as possible, subject to Applicable Laws, including GCP. At Sutro’s request, Licensee and Sutro shall reasonably cooperate to transfer the Development and Commercialization activities pertaining to  the Product in the Territory to Sutro in an orderly fashion. The license granted under Section 8.02 shall automatically be expanded to become exclusive also within the Territory (including as to Licensee and its Affiliates).

  (b)Each Party shall return or destroy all tangible materials in its possession or control containing or comprising the other Party’s Confidential Information to which such first Party does not retain rights hereunder (except one copy thereof, which may be retained by the returning Party solely for legal archive purposes). Notwithstanding any provision to the contrary set forth in this Agreement, the returning Party will not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information.

  (c)Licensee shall, in accordance with Applicable Laws, as promptly as reasonably practical transfer to Sutro all of Licensee’s rights, title, and interests in and to  INDs, BLAs, Drug Approval Applications, and Regulatory Approvals (and any other permits or licenses necessary to Develop, Manufacture or Commercialize the Product in the Territory) with respect to the Product in the Territory, and shall take such other actions and execute such other instruments, assignments, and documents as may be necessary to effect the transfer of rights hereunder to Sutro. Without limiting the generality of the foregoing, Licensee (if it is the marketing authorization holder at such time) agrees to submit to the NMPA and other Regulatory Authorities in jurisdictions in which any regulatory filings have been made with respect to the Product, within [*] after the effective date of such termination, a letter (with copy to Sutro) notifying the NMPA and such other Regulatory Authorities of the transfer of any regulatory filings for the Product in such jurisdictions from Licensee to Sutro. Additionally, (i) Licensee will provide Sutro with copies of regulatory filings necessary to practice the rights granted to it under this Section 11.03(c) and (ii) Sutro will be allowed to use the Licensee Development Data also in the Territory.

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  (d)Upon Sutro’s request, Licensee will assign (or cause its Affiliates to assign) to Sutro, at Sutro’s request, all of Licensee’s (or its Affiliates’) rights and obligations under agreements with Third Parties with respect to (i) the conduct of clinical trials for the Product, including Agreements with CROs, clinical sites and investigators that relate to clinical trials in support of Regulatory Approvals in the Territory, and (ii) any other Third Party agreements involving the Development or Commercialization of the Product, unless in each of (i) or (ii), such agreement is not permitted to be assigned pursuant to its terms or relates to products other than the Product, in which case Licensee will cooperate with Sutro in all reasonable respects to transfer as promptly as reasonably practical to Sutro the benefit of such contract in another mutually acceptable manner and upon Sutro’s request facilitate discussions between Sutro and such Third Parties to assist Sutro in entering into a direct agreement with such Third Parties.

  (e)To the extent they are assignable and as requested by Sutro, Licensee shall execute any documents necessary to transfer to Sutro rights under any Third Party licenses obtained by Licensee pursuant to and during the course of the term of this Agreement for the purpose of Exploiting the Product, and Sutro shall thereafter be responsible for all costs, expenses and obligations associated with such Third Party licenses.

  (f)Except where expressly provided for otherwise in this Agreement, termination of this Agreement shall not relieve the Parties of any liability, including without limitation any obligation to make payments hereunder, which accrued hereunder prior to the effective date of such termination, nor preclude any Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice any Party’s right to obtain performance of any obligation. In the event of such termination, this Section 11.03(f) shall survive in addition to others specified in this Agreement to survive in such event.

  (g)Licensee shall be entitled, during a period of [*] following the Licensee Triggered Termination to sell any inventory of Product that remains on hand as of the date of the termination, so long as Licensee pays to Sutro the royalties applicable to said subsequent sales in accordance with the terms and conditions set forth in this Agreement.

  (h)Notwithstanding anything else set forth in this Agreement, (i) Licensee shall not have any obligations to continue any Development or Commercialization with respect to particular doses of the Product if Licensee has terminated this Agreement pursuant to Section 11.02(d) with reference to any material safety concerns regarding such doses, as determined by the JSC; and (ii) should Sutro elect to pursue any Development or Commercialization of Product following any such termination by Licensee, Sutro shall,  without prejudice to or limitation of any other or further obligations under this Agreement (including Section 12.01(b)),  indemnify Licensee for any Third Party Claims arising from Sutro’s Development or Commercialization after the effective date of such termination as set forth in Section 12.01(b).

  Section 11.04. Consequences of Termination by Licensee for Sutro’s Breach or Insolvency. If Licensee terminates this Agreement pursuant to Section 11.02(a) as a result of a material breach by Sutro or Section 11.02(c) for an insolvency or other transaction described therein affecting Sutro, the terms and obligations under Section 11.03 shall apply as if such termination were a Licensee Triggered Termination, except that notwithstanding anything set forth to the contrary in Section 11.03: (i) Sutro shall be responsible for any and all reasonable costs and 

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  expenses associated with the discontinuation  of the Development and Commercialization activities by Licensee and  the transfer of such activities to Sutro pursuant to Section 11.03(a), including without limitation, costs and expenses of clinical trials incurred by Licensee’s after the termination date and reasonable costs and expenses associated with the winding down of ongoing clinical trials,  (ii) Sutro shall be responsible for any and all reasonable costs and expenses associated with the transfer of regulatory filings pursuant to Section 11.03(c), the assignment or transfer of Third Party agreements and licenses pursuant to Section 11.03(d) and Section 11.03(e). The foregoing shall be in addition and without prejudice to any other remedies that may be available to Licensee due to Sutro’s breach, including any money damages that may be awarded to Licensee in connection with its termination pursuant to Section 11.02(a).

  Section 11.05Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by a Party are, and shall otherwise be deemed to be, for the purposes of Section 365(n) of the United States Bankruptcy Code (to the extent applicable), licenses of rights to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code or equivalent provisions of applicable legislation in any other jurisdiction. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the United States Bankruptcy Code, or equivalent provisions of applicable legislation in any other jurisdiction. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the Unites States Bankruptcy Code or equivalent provisions of applicable legislation in any other jurisdiction, the Party that is not a party to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non-subject Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under subsection (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.

  Section 11.06Surviving Rights and Obligations. The rights and obligations set forth in this Agreement shall extend beyond the expiration or termination of the Agreement only to the extent expressly provided for herein, or to the extent that the survival of such rights or obligations are necessary to permit their complete fulfillment or discharge. Without limiting the foregoing, the Parties have identified various rights and obligations which are understood to survive, as follows: Article 1 (to the extent applicable to surviving provisions), Article 6 (limited to Net Sales realized prior to, and payments due as of, the expiration or termination of this Agreement), Article 7 (for the time periods specified in Section 7.05),Section 8.01, Section 8.02, Section 8.04 (limited to proceedings commenced before expiration or termination of this Agreement),Article 10, Section 11.03, Section 11.04, Section 11.06, Section 11.07, Article 12, Article 13, and Article 14.

  Section 11.07Accrued Rights. Termination, relinquishment, or expiration of the Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of either Party prior to such termination, relinquishment, or expiration, including without limitation damages arising from any breach hereunder. Such termination, relinquishment, or expiration shall not relieve either Party from obligations that are expressly indicated to survive termination or expiration of the Agreement.

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  Article 12
INDEMNIFICATION

  Section 12.01Indemnification.

  (a)Licensee hereby agrees to indemnify, defend, and hold harmless Sutro, its Affiliates, and each of its and their respective employees, officers, directors and agents from and against any and all Losses incurred by them resulting from or arising out of or in connection with any suits, claims, actions or demands made or brought by a Sublicensee or other Third Party (collectively, “Third Party Claims”) against Sutro, its Affiliates or their respective employees, officers, directors or agents, that result from or arise out of: (i)  activities by Licensee, its Affiliates or Sublicensees with respect to the  Development, Manufacture, and Commercialization of the Product or the exercise of their rights or performance of their obligations related thereto, including the activities taken on behalf of Sutro under Section 4.06; (ii) any violation of Applicable Law by Licensee, its Affiliates or Sublicensees in performing Licensee’s obligation under this Agreement; and (iii) any material breach by Licensee, its Affiliates or Sublicensees of Licensee’s representations, warranties and/or obligations under this Agreement; except in any case, to the extent such Losses are Losses for which Sutro has an obligation to indemnify Licensee, its Affiliates or their respective employees, officers, directors or agents pursuant to Section 12.01(b), as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses.

  (b)Sutro hereby agrees to indemnify, defend and hold harmless Licensee, its Affiliates, and each of its and their respective employees, officers, directors and agents from and against any and all Losses incurred by them resulting from or arising out of or in connection with any Third Party Claims against Licensee, its Affiliates or their respective employees, officers, directors or agents, that result from or arise out of: (i)  activities by Sutro, its Affiliates or subcontractors with respect to the  Development, Manufacture, and Commercialization of the Product or the exercise of their rights or performance of their obligations related thereto, provided that, the activities taken by Licensee on behalf of Sutro under Section 4.06 shall not be considered activities by Sutro, its Affiliates or subcontractors; (ii) any violation of Applicable Law by Sutro or its Affiliates in performing Sutro’s obligations under this Agreement; and (iii) any material breach by Sutro or its Affiliates of Sutro’s representations, warranties and/or obligations under this Agreement; except in any case, to the extent such Losses are Losses for which Licensee has an obligation to indemnify Sutro, its Affiliates or their respective employees, officers, directors or agents pursuant to Section 12.01(a), as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses.

  Section 12.02Mechanism.

  (a)In the event that a Party (the “Indemnified Party”) is seeking indemnification under Section 12.01(a) or Section 12.01(b), it shall notify the other Party (the “Indemnifying Party”) in writing of the relevant Third Party Claim and the relevant Loss for which indemnification is being sought as soon as reasonably practicable after it becomes aware of such claim. Each such notice shall contain a description of the Third Party Claim and the nature and amount of the Loss claimed (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all 

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  papers and official documents received in respect of any such Third Party Claim or Losses. For the avoidance of doubt, all indemnification claims in respect of a Party, its Affiliates, and each of its and their respective employees, officers, directors and agents shall be made solely by such Party to this Agreement. The Indemnified Party shall permit the Indemnifying Party to assume direction and control of the defense of the relevant Third Party Claim (including without limitation the right to settle the claim solely for monetary consideration), and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim. The assumption of the defense of a Third Party Claim by the Indemnifying Party shall not be construed as an acknowledgement that the Indemnifying Party is liable to indemnify any Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification.

  (b)Notwithstanding Section 12.01, the failure to give timely notice to the Indemnifying Party shall not release the Indemnifying Party from any liability to the Indemnified Party to the extent the Indemnifying Party is not materially prejudiced thereby and, for the avoidance of doubt, the Indemnifying Party shall not be liable to the extent any Loss is caused by any delay by the Indemnified Party in providing such notice. Notwithstanding the provisions of Section 12.02(a) requiring the Indemnified Party to tender to the Indemnifying Party the exclusive ability to defend such claim, if the Indemnifying Party declines to or fails to timely assume control of the relevant Third Party Claim, the Indemnified Party shall be entitled to assume such control, conduct the defense of, and settle such claim, all at the sole costs and expense of the declining or failing Party; provided, however, that neither Party shall settle or dispose of any such claim in any manner that would adversely affect the rights or interests or admit fault, of the other Party without the prior written consent of such other Party, which shall not be unreasonably withheld, delayed or conditioned. Each Party, at the other Party’s expense and reasonable request, shall cooperate with such other Party and its counsel in the course of the defense or settlement of any such claim, such cooperation to include without limitation using reasonable efforts to provide or make available documents, information, and witnesses.

  Section 12.03Mitigation of Loss. Each Indemnified Party shall take and shall ensure that its Affiliates take all such reasonable steps and action as are reasonably necessary or as the Indemnifying Party may reasonably require in order to mitigate any claims (or potential losses or damages) under this Article 12. Nothing in this Agreement shall or shall be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it.

  Section 12.04Insurance. Both Parties shall use Commercially Reasonable Efforts, at their own discretion, to procure and maintain insurance, including product liability insurance, with respect to its activities hereunder and which is consistent with normal and customary business practices in the pharmaceutical industry for Persons similarly situated, and shall upon request provide the other Party with a copy of its policies of insurance in that regard, along with any amendments and revisions thereto. Each party shall still be responsible for its liability at its own risk whether it does or doesn’t procure or maintain such insurance. Such insurance shall not be construed to create a limit of both Party’s liability with respect to its indemnification obligations under this Article 12.

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  Article 13
DISPUTE RESOLUTION

  Section 13.01Referral of Disputes to the Parties Senior Executives. Subject to the applicable provisions in Article 13, in the event of any dispute between the Parties arising out of or in connection with this Agreement, either Party may, by written notice to the other, have such dispute referred to the Senior Executives for attempted resolution by good faith negotiations within [*] after such notice is received.  If the Senior Executives fail to resolve such matter within [*] after the date on which the matter is referred to the Senior Executives (unless a longer period is agreed to by the Parties), then, either Party may submit the dispute for final resolution by binding arbitration in accordance with Section 13.02.

  Section 13.02Arbitration. Except as set forth in this Section 13.02, any dispute, difference, controversy or claim arising in connection with or related or incidental to, or question occurring under, this Agreement or the subject matter hereof that cannot be resolved pursuant to Section 13.01, will be referred to and finally resolved by arbitration in accordance with this Section 13.02. A Party may submit such dispute to arbitration at [*] (“SIAC”) by notifying the other Party, in writing, of such dispute. Within [*] after receipt of such notice, the Parties will each designate in writing an arbitrator to resolve the dispute. Both of the designated arbitrators will elect a third arbitrator; provided, however, that if the designated arbitrators cannot agree on a third arbitrator within [*] after both arbitrators have been designated, the third arbitrator will be selected by the SIAC. The arbitrators will be a lawyer with biotechnology and/or pharmaceutical industry legal experience, and will not be an Affiliate, employee, consultant, officer, director or stockholder of any Party. The arbitration will be conducted in [*] for the time being in force, which rules are deemed to be incorporated by reference in this clause, except to the extent such rules are inconsistent with this Section 13.02, in which case this Section 13.02 will control. All arbitration proceedings will be conducted in the English language. The arbitrators will consider grants of equitable relief and orders for specific performance as co-equal remedies along with awards of monetary damages. The arbitrators will have no authority to award punitive damages. The prevailing Party of the arbitration shall be entitled to recover from the other any and all costs and expenses incurred by the prevailing Party in connection with the arbitration, including reasonable attorneys’ fees. The Parties hereby agree that the arbitrators have authority to issue rulings and orders regarding all procedural and evidentiary matters that the arbitrators deem reasonable and necessary with or without petition therefore by the Parties as well as the final ruling and judgment. All rulings by the arbitrators will be final. Notwithstanding any contrary provision of this Agreement, any Party may seek equitable measures of protection in the form of attachment of assets or injunctive relief (including specific performance and injunctive relief) in any matter relating to the proprietary rights and interests of either Party from any court of competent jurisdiction, pending a decision by the arbitral tribunal in accordance with this Section 13.02. The Parties hereby exclude any right of appeal to any court on the merits of such matter. The provisions of this Section 13.02 may be enforced and judgment on the award (including equitable remedies) granted in any arbitration hereunder may be entered in any court having jurisdiction over the award or any of the Parties or any of their respective assets. Except to the extent necessary to confirm an award or as may be required by Laws, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. The Parties agree that, in the event of a dispute over the nature or quality of performance under this Agreement, neither Party may terminate this Agreement until final resolution of the dispute through arbitration 

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  or other judicial determination. Nothing in this Section 13.02 will preclude either Party from seeking interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. Notwithstanding the Parties’ agreement to arbitrate, unless the Parties agree in writing in any particular case, claims and disputes between the Parties relating to or arising out of, or for which resolution depends in whole or in part on a determination of the interpretation, scope, validity, enforceability or infringement of, Patents or of any Trademark rights relating to the  Product, or misappropriation of any Know-How, will not be subject to arbitration under this Agreement, and the Parties may pursue whatever rights and remedies may be available to them under law or equity, including litigation in a court of competent jurisdiction, with respect to such claims and disputes.

  Section 13.03Preliminary Injunctions. Notwithstanding anything to the contrary, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the decision of the arbitrator(s) on the ultimate merits of any dispute.

  Section 13.04Patent Disputes. Notwithstanding anything to the contrary, any and all issues regarding the scope, inventorship, construction, validity, or enforceability of Patents shall be by the competent Court(s) under the local patent laws of the jurisdictions having issued the Patents in question.

  Section 13.05Confidentiality. All proceedings and decisions of a mediator or arbitrator(s) in connection with proceedings pursuant to Section 13.02 shall be deemed Confidential Information of each of the Parties and shall be subject to Article 7.

  Article 14
MISCELLANEOUS

  Section 14.01Assignment; Performance by Affiliates.

  (a)Neither Party may assign any of its rights or obligations under this Agreement in any Region in whole or in part without the prior written consent of the other Party, except that each Party shall have the right, without such consent, (i) to perform any of its obligations and exercise any of its rights under this Agreement through, and to assign all of its rights and obligations under this Agreement to, any of its Affiliates, provided that such performance or exercise by such Affiliate, or such assignment, as applicable, could not reasonably be expected to subject the other Party to any adverse Tax consequences with regard to any payments under this Agreement; and (ii) on written notice to the other Party, to assign all of its rights and obligations under this Agreement to a non-Affiliate successor in interest, whether by a Change of Control transaction or otherwise, to all or substantially all of the business to which this Agreement relates; however, provided that both under (i) and (ii) the assignee shall have at least the same capability and capacity of such Party to perform any obligations and exercise any rights under this Agreement. In the event that a Party performs its obligations or exercises its rights under this Agreement through an Affiliate (without having assigned all of its rights and obligations to such Affiliate as permitted under this Section 14.01), doing so shall not relieve the relevant Party of its 

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  responsibilities for the performance of its obligations under this Agreement, and the relevant Party shall remain responsible for the performance by its Affiliates and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance.

  (b)This Agreement shall survive any succession of interest permitted pursuant to Section 14.01(a)(ii), whether by merger, consolidation, reorganization, acquisition, stock purchase, asset purchase or other Change of Control transaction.

  (c)This Agreement shall be binding upon and inure to the benefit of the successors, and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void.

  Section 14.02Force Majeure. In this Agreement, “Force Majeure” means an event which is beyond a non-performing Party’s reasonable control, including an act of God, strike, lock-out or other industrial/labor disputes (whether involving the workforce of the Party so prevented or of any other Person), war, riot, civil commotion, terrorist act, epidemic (including the COVID-19), quarantine, fire, flood, storm, earthquake, natural disaster, act of government  or compliance with any law or governmental order, rule, regulation or direction, whether or not it is later held to be invalid. A Party that is prevented or delayed in its performance under this Agreement by an event of Force Majeure (a “Force Majeure Party”) shall, as soon as reasonably practical but no later than [*] after the occurrence of a Force Majeure event, give notice in writing to the other Party specifying the nature and extent of the event of Force Majeure, its anticipated duration and any action being taken to avoid or minimize its effect, except if the action of giving such notice is also not practical or practicable. Subject to providing such notice unless excepted and to this Section 14.02, the Force Majeure Party shall not be liable for delay in performance or for non‐performance of its obligations under this Agreement, in whole or in part, except as otherwise provided in this Agreement, where non-performance or delay in performance has resulted from an event of Force Majeure. The suspension of performance allowed hereunder shall be of no greater scope and no longer duration than is reasonably required and the Force Majeure Party shall exert all reasonable efforts to avoid or remedy such Force Majeure. Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder at the time of such Force Majeure because of such Force Majeure. If a Force Majeure persists for more than [*], the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement to mitigate the delays caused by such Force Majeure.

  Section 14.03Further Actions. Each Party agrees to execute, acknowledge, and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

  Section 14.04Notices. All notices, requests, waivers and other communications made hereunder shall be in writing and shall be deemed given (a) upon delivery, if delivered personally; (b) upon confirmation of receipt, if by electronic mail during normal business hours of the recipient, and if not sent during normal business hours, then on the recipient’s next Business Day, (c) [*] after deposit in the mail as registered or certified mail (unless earlier return receipt requested), (d) [*] after deposit with postage prepaid, or sent by internationally recognized overnight delivery service that maintains earlier records of delivery, to the Parties at the following 

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  addresses (or at such other address for a Party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof).

  If to Sutro, addressed to:

  SUTRO Biopharma, Inc.

  111 Oyster Point Boulevard

  South San Francisco, CA 94080

  Attention: General Counsel

  Email: [*] 

   

  If to Licensee, addressed to:

  Tasly Biopharmaceuticals Co., Ltd.

  280 JuLi Road, 

  China (Shanghai) Pilot Free Trade Zone, P.C.201203

  Attention: [*]

  Email: [*]

   

  Section 14.05Waiver. Except as specifically provided for herein, the waiver from time to time by  either of the Parties of any of their rights or their failure to exercise any remedy shall not operate or be construed as a waiver of any other of such Party’s rights or remedies provided in this Agreement.

  Section 14.06Severability. If any term, covenant or condition of this Agreement or the application thereof to any Party or circumstance shall, to any extent, be held to be invalid or unenforceable, then (a) the remainder of this Agreement, or the application of such term, covenant, or condition to Parties or circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby, and each term, covenant, or condition of this Agreement shall be valid and be enforced to the fullest extent permitted by law, and (b) the Parties covenant and agree to renegotiate any such term, covenant, or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant, or condition of this Agreement or the application thereof that is invalid or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.

  Section 14.07Governing Law. This Agreement shall be governed by and interpreted under the laws of the State of New York, USA, without giving effect to any conflict of law principle that would otherwise result in the application of the laws of any State or jurisdiction other than the State of New York, USA.

  Section 14.08Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

  Section 14.09Entire Agreement. This Agreement, including without limitation all exhibits attached hereto, sets forth all the covenants, promises, agreements, warranties, 

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  representations, conditions, and understandings between the Parties and supersedes and terminates all prior and contemporaneous agreements and understanding between the Parties, including without limitation the agreements and amendments set forth in Section 7.06. There are no covenants, promises, agreements, warranties, representations, conditions, or understandings, either oral or written, between the Parties other than as set forth in this Agreement. No subsequent alteration, amendment, change, or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by the respective authorized officers of the Parties.

  Section 14.10Limitation of Liability. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO THIRD PARTY CLAIMS UNDER SECTION 12.01, IN NO EVENT SHALL EITHER PARTY OR ITS RESPECTIVE AFFILIATES AND SUBLICENSEES BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, REV  ENUE, MILESTONES OR ROYALTIES. This Section 14.10 shall not limit either Party’s obligations under Article 12.

  Section 14.11No Partnership. It is expressly agreed that the relationship between Sutro and Licensee shall not constitute a partnership, joint venture, or agency. Neither Sutro nor Licensee shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of such other Party to do so.

   

  [SIGNATURE PAGE FOLLOWS]

   

   

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  [SIGNATURE PAGE]

   

   

  IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in duplicate by their respective duly authorized officers or representatives.

   

  
Sutro Biopharma, Inc.

   

   

  By: _____________________

  Name: William Newell

  Title:   Chief Executive Officer

   

   

  
Tasly Biopharmaceuticals Co., Ltd.

   

   

  By:______________________

  Name:  Kaijing Yan

  Title:   Chairman of the Board

   

   

   

  	58	

   

  

  EXHIBIT A

  (Sutro Patents)

  [*]

   

   

   

   

   

   

  	59	

   

  

  EXHIBIT B

   

  (Licensed Compound)

  [*]

   

   

   

   

   

  	60	

   

  

  EXHIBIT C

   

  (List of JSC Members)

  [*]

   

   

  	61	

   

  

  EXHIBIT D

   

  (Development Plan)[*]

   

   

  EXHIBIT E

   

  (Sutro Trademarks)

  [*]

   

   

   

   

   

   

  	62	

   

  

  EXHIBIT F

  (Terms for Clinical Supply Agreement)

  [*]

   

   

   

  	63

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00341-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00341-of-00352.parquet"}]]