Onkar Bhondwe  
Data Scientist  
  
• +91 937 032 5908   • English , Hindi , Marathi   
• onkarbhondwe1997@gmail.com   • LinkedIn  - Onkar Bhondwe  
Summary  
Experienced Data Scientist with a strong background in  retail  and e-commerce  domain  using NLP and CV similarity algorithms. Skilled 
in developing efficient data pipelines for real -time data processing and creating interactive visualization reports using Looker Studio. 
Proficient in developing Python -based applications for IoT sensors and data visualizati on in prior experience as a Python Developer  
Work Experience  
FlairMinds , Pune  
Data Scientist  July 2022  – Present  
Sales Forecasting and Dashboard  
• Designed and implemented an automated data extraction system using Azure Form Recognizer  for efficient data capture, 
streamlining the input process for subsequent analysis.

• Developed a dynamic Sales Prediction Dashboard employing Azure Functions  for preprocessing and Azure ML Studio  to 
create Regression -based sales forecasts, facilitating informed decision -making for sales optimization.  
Carbon Emission Scoring Engine  
• Designed and implemented a robust Flask/Postgres  backend, incorporating JWT -based authentication, intricate filtering 
mechanisms, and systematic JSON rendering for the Carbon Emission Scoring Engine.  
• Engineered a versatile data ingestion  script, seamlessly harmonizing heterogeneous data sources into a coherent database 
schema, ensuring data consistency and integrity.  
• Spearheaded the development of a sophisticated endpoint utilizing a text similarity  model, enabling dynamic mapping of 
user -entered activities to the database. Employed iterative user feedback to fine-tune  the model, enhancing precision and

responsiveness.  
Product  Matching  across competitions  
• Implemented an end -to-end product matching model in GCP Vertex AI , encompassing data cleaning, NLP, and Computer 
Vision algorithms for accurate matching  
• Developed a streamlined matching script utilizing advanced similarity models  Sentence  Transformers  and FAISS  indexing  to 
handle large -scale product matching within subcategories  
• Analyzed data using BigQuery  and Looker Studio  to extract insights, identify patterns, and achieve a high -quality control rate 
of 94%  in identifying matching pairs  
Document  Search as a Service  
• Built  a Java Maven -based Spring Boot backend repository, collaboratively shared with the client, and containerized it using 
Docker . 
• Orchestrated the integration of multiple services, including Java Spring Boot backend, SQL, ElasticSearch, and a React -Flask

integrated frontend, using Docker Compose  
• Successfully deployed the containerized service on Azure Container Instances  and implemented customized configuration  of 
mapping templates  and efficient index creation in Azure ElasticSearch  
Automati ng Financial  Portfolios  
• Script ed the traditional  calculations for financial portfolios done in spreadsheet  
• Automated complex calculations for numerous columns using pandas and exposed them as Flask backend  APIs, enhancing 
accessibility and efficiency  
• Implemented a streamlined deployment workflow using GitHub Actions , enabling seamless deployment of changes to Azure 
App Services  upon Git push  
Data  Deduplication  API 
• Implemented efficient data deduplication  by searching for  similar matches  to newly created data , returning confidence score

of the record match present in database  resulting in higher accuracy and improved data quality  
• Utilized Postgres parallel queries  to ensure efficient processing  with minimum execution time , resulting in faster data 
deduplication  and reduced  processing times  
• Built a Python  Flask  REST  API to enable faster execution and easier access  to the deduplication system, facilitating seamless 
integration  with frontend  
OM SOFTWARES  
Python  Developer (IOT)  Internship  July 2021 – March  2022 
• Developed embedded applications using python PyQT5  framework with C# REST API as backend  
• Built  dynamic webpages using flask for data visualizations  
• Developed Desktop applications  using python PyQt5 for interfacing and applying programming logic to create balanced

applications  • Interfac ed different IOT sensors  with desktop applications through raspberry pi, which would eventually be used as input 
source for data collection and acquisition  
Education  
AISSMS  College of Engineering , Pune,  India  July 2010 – June 2014  
Bachelor of Engineering  in Computer Science and Engineering   
Skills   
Python , NLP , Computer Vision,  Microsoft Azure : Azure App Services, Azure Functions, Azure Container Instances , Azure 
ElasticSearch ; Google Looker Studio, GCP: Vertex AI, Bigquery ; TensorFlow, scikit-learn , Docker , Docker Compose , Git, Postgre SQL

Education  
Skills   
ElasticSearch ; Google Looker Studio, GCP: Vertex AI, Bigquery ; TensorFlow, scikit-learn , Docker , Docker Compose , Git, Postgre SQL 
  
CONTACT  
 
+91 9370325908  
live:.cid.61075d22751f0087  
onkar.bhondwe@flairminds.com  PROFILE  
 
Data  Science  enthusiast,  currently  working  at FlairMinds  Pune  as Data  Scientist,  
currently working on similarity algorithms for product matching from various e -

commerce  websites using  ML techniques,  NLP and  CV algorithms.  
 
SKILLS  
 
◦ PYTHON  
◦ GCP 
◦ BIGQUERY  
◦ Data / Looker Studio  
◦ NLP 
◦ COMPUTER  VISION  
 
EDUCATION  
B.E. Computer Scie nce 
AISSMS College of Engineering, Pune  
Bachelorette degree of computer  
Engineering  from  Savitribai  Phule  Pune  
University  (SPPU).  EXPERIENCE  
 
Data  Scientist,  FlairMinds  Software  Pvt. Ltd. 
July 2022  - Present  
Product  Matching  from  various  e-commerce  websites  
• Development  of end-to-end model  for products  matching  which  contained  data  
cleaning, data exploration, data preparation for applying NLP and CV similarity  
algorithms.  
• Make  use of similarity  algorithms,  ML techniques  for NLP matching  tasks.  
• Creating  Data  pipeline  for real time  data  processing  for periodically  increasing  
products  data.

• Ensemble of similarity models for about nearly 2M products daily based on  
product’s  title,  description,  price  outlier,  attributes  and product  images  and 
industrial scaling  for the  real-time  processing.  
Looker Studio Dashboard Visualization:  
• Creating Interactive Visualization Reports for presenting the product matching 
results with the client.  
• Looker studio tables, charts and graphs for visualization of insights from the data  
• Efficient  Data  Deduplication  by searching  similar  matches  to the newly  created  
data.  
• Postgres  parallel  queries  for efficient  processing  with  minimum  execution  time.  
• Python  Flask API  for faster  execution  and easier  access.  
 
Python  Developer  (IOT)  Intern ship, Om Software  Pvt. Ltd. 
2021  - 2022

• Developed  embedded  applications  using  python  PyQT5  framework  with  C# REST  
API as backend.  
• Created  dynamic  webpages  using  flask  for data visualizations.  
• Developed  Desktop  applications  using  python  PyQt5  for interfacing  and applying  
programming  logic to create balanced  applications.  
• Interfacing  different  IOT sensors  with  desktop  applications  through  raspberry pi,  
which would eventually be used as input source for data collection and  
acquisition.  ONKAR  BHONDWE  
DATA  SCIENTIST

EX-10.6 10 d549494dex106.htm EX-10.6
EXHIBIT 10.6

CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Execution Copy

LICENSE AGREEMENT

This License Agreement (this “Agreement”) is entered into as of this 2nd day of November, 2016 (the “Effective Date”), by and between Magenta Therapeutics, Inc., a corporation existing under the laws of the State of Delaware, having a place of business at 245 First St. 4th Floor, Cambridge MA 02142 (“Licensee”) and President and Fellows of Harvard College, an educational and charitable corporation existing under the laws and the constitution of the Commonwealth of Massachusetts, having a place of business at Richard A. and Susan F. Smith Campus Center, Suite 727, 1350 Massachusetts Avenue, Cambridge, Massachusetts 02138 (“Harvard”).

WHEREAS, the technology claimed in the Patent Rights (as defined below) was developed through research conducted by Dr. David T. Scadden and other Harvard researchers;

WHEREAS, Harvard owns the Patent Rights related to Harvard Case #[***], as described in Exhibit 1.18 hereto, jointly with The General Hospital Corporation d/b/a Massachusetts General Hospital, with offices at 55 Fruit Street, Boston, MA 02114 (“MGH”), and Children’s Medical Center Corporation, with offices at 300 Longwood Avenue, Boston, MA 02115 (“Children’s,” and collectively with MGH and Harvard, the “Institutions”), and Harvard owns the Patent Rights related to Harvard Case ## [***] and [***], as described in Exhibit 1.18 hereto, jointly with MGH;

WHEREAS, as between the Institutions, Harvard has the sole and exclusive right and authority to grant licenses under the Patent Rights, on behalf of itself, Children’s and MGH, pursuant to that certain Invention Administration Agreement dated as of October 4, 2016, by and between Harvard, Children’s and MGH, and pursuant to that certain Invention Administration Agreement dated as of November 2, 2016, by and between Harvard and MGH;

WHEREAS, Licensee wishes to obtain a license under the Patent Rights;

WHEREAS, Harvard desires to have products based on the inventions described in the Patent Rights developed and commercialized to benefit the public;

WHEREAS, such products and/or services may be applicable to the improvement of the health of individuals throughout the world; and

WHEREAS, Licensee has represented to Harvard, in order to induce Harvard to enter into this Agreement, that Licensee shall commit itself to commercially reasonable efforts to develop, obtain regulatory approval for and commercialize such products;

NOW, THEREFORE, in consideration of the mutual covenants and promises herein, the sufficiency of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:

1. Definitions.

As used in this Agreement, the terms with initial letters capitalized, whether used in the singular or plural form, shall have the meanings set forth in this Article 1 or, if not listed below, the meaning designated in places throughout this Agreement.

1.1. “Affiliate” means, with respect to a person, organization or entity, any person, organization or entity controlling, controlled by or under common control with, such person, organization or entity. For purposes of this definition only, “control” of another person, organization or entity will mean the possession, directly or indirectly, of the power to direct or cause the direction of the activities, management or policies of such person, organization or entity, whether through the ownership of voting securities, by contract or otherwise. Without limiting the foregoing, control will be presumed to exist when a person, organization or entity (a) owns or directly controls fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity or (b) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the other organization or entity. The parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such cases such lower percentage will be substituted in the preceding sentence.

1.2. “Calendar Quarter” means each of the periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31 during the Term.

1.3. “Commercially Reasonable Efforts” means the level of efforts and resources consistent with the efforts and resources normally used by a similarly situated biotechnology company in the exercise of commercially reasonable business discretion relating to the development, manufacture or commercialization of a biopharmaceutical product with similar scientific and technical product characteristics that is of similar market potential at a similar stage of development or commercialization, taking into account issues of efficacy, safety, product profile, anticipated or approved labeling, present and future market potential, competitive market conditions, the proprietary position of the drug substance or product, the regulatory structure involved, the complexity, costs and challenges of clinical development, and other key technical, legal, scientific, medical or commercial factors or challenges, and the likely profitability of the product.

1.4. “Covered” means, when referring to an invention, an invention is disclosed in a patent or pending patent application and is recited in one or more claims of said patent or patent application.

1.5. “Development Milestones” means the development and commercialization milestones set forth in Exhibit 1.5 hereto.

1.6. “Development Plan” means the plan for the development and commercialization of Licensed Products attached hereto as Exhibit 1.6, as such plan may be adjusted from time to time pursuant to Section 3.2.

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1.7. “Dominated by” means, when used to refer to any invention as “Dominated by” any other patent or patent application, that, without a license to practice such other patent or patent application, the practice of such invention would infringe at least one claim made under such other patent or patent application.

1.8. “FDA” means the United States Food and Drug Administration.

1.9. “Field” means the treatment, palliation or prevention of any disease, disorder or condition in humans or animals.

1.10. “First Commercial Sale” means the date of the first sale by Licensee, its Affiliate or a Sublicensee of a Licensed Product to a Third Party for end use or consumption of such Licensed Product following receipt of any required Marketing Authorization in the country in which such Licensed Product is sold, excluding, however, any sale or other distribution for use in a clinical study.

1.11. “Improvement” means a patentable invention (a) disclosed to Harvard’s Office of Technology Development within [***] following the Effective Date; (b) that is Dominated by a claim of a granted patent of the Patent Rights or would be Dominated by a claim of a pending application of the Patent Rights, (c) arises [***], and (d) is available for licensing after satisfaction of any obligations to Third Parties under binding agreements with such Third Parties, including without limitation, sponsors of the research leading to such invention.

1.12. “Infringed Patent” means an issued and unexpired patent, or a pending patent application not within the Patent Rights (a) that is not Dominated by a Valid Claim, (b) has not been abandoned, held invalid, revoked, held or rendered unenforceable or lost through interference, and (c) the claims of which would be infringed by Licensee’s making, using, selling, offering for sale or importing of a Type I Licensed Product.

1.13. “IND” means an FDA investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in any country in conformance with the requirements of such Regulatory Authority.

1.14. “Licensed Product” means any Type I Licensed Product and any Type II Licensed Product.

1.15. “Marketing Authorization” means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in a country.

1.16. “Net Sales” means the gross amount billed or invoiced by or on behalf of Licensee, any Sublicensee or any of their Affiliates (each, an “Invoicing Entity”) from the sales of Licensed Products to independent third party customers by or on behalf of Licensee, such Sublicensee or Affiliate, as applicable, in bona-fide arms-length transactions less the following deductions, which may not exceed reasonable and customary amounts in the biopharmaceutical industry in the country in which the transaction occurs:

 	(a)	Customer freight charges actually paid by the Invoicing Entity;
 
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 	(b)	Trade, quantity, cash or other discounts and brokers’ or agents’ commissions, if any, actually allowed and taken by the Invoicing Entity;
 
 	(c)	Price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees;
 
 	(d)	Credits or allowances made or given on account of rejects, defects, recalls, returns, or retroactive price reductions for any amount not collected that are specifically identifiable or allocable to Licensed Products; and

(e)	Any tax or governmental charge directly on sale or transportation, use or delivery of products paid by or on behalf of the Invoicing Entity and not recovered from the purchaser, but not including any tax levied with respect to income.
In the event that an Invoicing Entity receives non-cash consideration for any Licensed Products or in the case of transactions not at arm’s length with a non-Affiliate of an Invoicing Entity, Net Sales will be calculated based on the fair market value of such consideration or transaction, assuming an arm’s length transaction made in the ordinary course of.

In any transfers of Licensed Products between an Invoicing Entity and an Affiliate of such Invoicing Entity not for the purpose of resale by such Affiliate, Net Sales will be equal to the fair market value of the Licensed Products so transferred, assuming an arm’s length transaction made in the ordinary course of business.

Sales of Licensed Products by an Invoicing Entity to its Affiliate or a Sublicensee for resale by such Affiliate or Sublicensee will not be deemed Net Sales. Instead, Net Sales will be determined based on the gross amount billed or invoiced by such Affiliate or Sublicensee upon resale of such Licensed Products to a third party purchaser.

Net Sales shall exclude sales or transfers of Licensed Products for charitable or government-approved programs for compassionate use purposes or named patient programs or any other similar program that provides for the legally-permitted sale or transfer to an end-user of a Licensed Product for such Licensed Product in such country.

1.17. “Non-Royalty Income” means any payments or other consideration that Licensee or any of its Affiliates receives in connection with a Sublicense or a Strategic Partnership, other than (a) royalties based on Net Sales, (b) amounts received to cover future reasonable, fully-burdened costs incurred by Licensee or its Affiliates in the performance of research and development of Licensed Products after the Effective Date, (c) amounts received as reimbursement for out-of-pocket costs incurred by Licensee in the preparation, filing, prosecution and maintenance of the Patent Rights, or (d) consideration for the issuance of equity or debt interests in Licensee to the extent the amount paid for such equity or debt does not exceed its fair market value; provided, that, [***]. If Licensee or its Affiliate receives non-cash consideration in connection with a Sublicense or Strategic Partnership or in the case of transactions not at arm’s length, Non-Royalty Income will be calculated based on the fair market value of such consideration or transaction, at the time of the transaction, assuming an arm’s length transaction made in the ordinary course of business. To the extent Licensee receives

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compensation for both a grant of a Sublicense of rights under Section 2.1 and the grant of other rights or licenses to intellectual property other than a Sublicense of rights granted under Section 2.1, other than a right or license to intellectual property not owned by Harvard but Dominated by any Valid Claim within the Patent Rights, such compensation will be reasonably apportioned between that amount attributable to the sublicense of rights under Section 2.1, which shall be deemed Non-Royalty Income, and that amount attributable to the grant of other rights or licenses in such other intellectual property, which shall be excluded from Non-Royalty Income, such apportionment to be reasonably agreed upon by the Parties; provided, that in any event, the portion of the total overall transaction value of such sublicenses attributable directly to the Sublicense of the Patent Rights shall not be less than 50%. For the avoidance of doubt, Non-Royalty Income shall not include consideration received by Licensee or its equityholders in connection with a merger, consolidation, or sale of equity, of Licensee, or the sale or transfer of all or substantially all of the assets or business of Licensee pertaining to the subject matter of this Agreement, to a successor (any such transaction to be referred to as an “M&A Transaction”).

1.18. “Patent Rights” means, in each case to the extent owned and controlled by Harvard: (a) the patents and patent applications listed in Exhibit 1.18 (including the PCT and/or U.S. utility application claiming priority to such application(s) that are filed on or before the one year conversion date of such application(s)); (b) any patent or patent application that claims priority to and is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent application identified in (a); (c) any patents issuing on any patent application identified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (d) any claim of a continuation-in-part application or patent (including any reissues, renewals, reexaminations, substitutions or extensions thereof) that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications identified in (a), (b) or (c); (e) any foreign counterpart (including PCTs) of any patent or patent application identified in (a), (b) or (c) or of the claims identified in (d); and (f) any supplementary protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents and patent applications identified in (a) through (e).

1.19. “Patient Treatment Purposes” means (i) use in patient care; or (ii) a clinical trial that is not funded or sponsored by any Third Party for-profit or commercial entity, and for which no Third Party for-profit or commercial entity acquires license rights, option rights or ownership of any results of such clinical trial.

1.20. “Phase 1 Clinical Study” means a clinical study in any country involving the initial introduction of an investigational new drug into humans, typically designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the United States, “Phase 1 Clinical Study” means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(a).

1.21. “Phase 2 Clinical Study” means a human clinical study in any country conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and, possibly, to determine the common short-term side effects and risks associated with the drug. In the United States, “Phase 2 Clinical Study” means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21 (b).

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1.22. “Phase 3 Clinical Study” means a human clinical study in any country, whether controlled or uncontrolled, that is performed after preliminary evidence suggesting effectiveness of the drug under evaluation has been obtained, and intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. In the United States, “Phase 3 Clinical Study means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21 (c).

1.23. “Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the manufacturing and marketing of a Licensed Product, including, in the United States, the FDA.

1.24. “Strategic Partner” means any entity that agrees to compensate Licensee or its Affiliate in exchange for: Licensee’s or its Affiliate’s practice of the Patent Rights and/or development of Licensed Products, on behalf of or in collaboration with such entity, including without limitation, for commercialization and development activities for Licensed Products. Any entity which meets the foregoing criteria, that also receives a Sublicense shall be considered a Sublicensee, and not a Strategic Partner, for the purposes of this Agreement.

1.25. “Strategic Partnership” means any agreement between Licensee or any of its Affiliates and a Strategic Partner.

1.26. “Sublicense” means: (a) any right granted, license given or agreement entered into by Licensee to or with any other person or entity, under or with respect to or permitting any use or exploitation of any of the Patent Rights or otherwise permitting the development, manufacture, marketing, distribution, use and/or sale of Licensed Products; (b) any option or other right granted by Licensee to any other person or entity to negotiate for or receive any of the rights described under clause (a); or (c) any standstill or similar obligation undertaken by Licensee toward any other person or entity not to grant any of the rights described in clause (a) or (b) to any third party; in each case regardless of whether such grant of rights, license given or agreement entered into is referred to or is described as a sublicense.

1.27. “Sublicensee” means any person or entity granted a Sublicense.

1.28. “Term” means the term of this Agreement as set forth in Section 10.1.

1.29. “Third Party” means any entity or person other than Harvard or Licensee or its Affiliates.

1.30. “Type I Licensed Product” means on a country-by-country basis, any product or service, the making, using, selling, offering for sale, importing, exporting or performing in the country in question would (without the license granted hereunder) infringe, directly, indirectly by inducement of infringement, or through contributory infringement, at least one pending Valid Claim (were it to have issued) or issued Valid Claim in that country.

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1.31. “Type II Licensed Product” means any product, other than a Type I Licensed Product, which (i) is a modification, improvement or optimization of a Type I Licensed Product, or (ii) is described in, or is developed through the practice of the technology enabled by the subject matter of the Patent Rights, including, without limitation, the Patent Rights listed on Exhibit 1.18 as of the Effective Date.

1.32. “Valid Claim” means: (a) a claim of an issued and unexpired patent within the Patent Rights that has not been (i) held permanently revoked, unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, (ii) rendered unenforceable through disclaimer or otherwise, (iii) abandoned or (iv) permanently lost through an interference or opposition proceeding without any right of appeal or review; or (b) a pending claim of a pending patent application within the Patent Rights that (i) has been asserted and continues to be prosecuted in good faith, (ii) has not been abandoned or finally rejected without the possibility of appeal or refiling, and (iii) has not been pending for more than seven (7) years from the date of issuance of the first substantive patent office action considering patentability of such claim by the relevant patent office in the country or territory in which such claim is pending. For purposes of calculating the end of the seven (7) years for which a given pending claim upon which a first substantive patent office action has been received remains a Valid Claim in accordance with clause (b)(iii) of the preceding sentence, that claim as originally filed and as it subsequently may be amended shall be deemed to be one and the same single claim entitled to a single period of seven (7) years, such period commencing upon the first substantive patent office action that occurs for any version of such single claim.

2. License.

2.1. License Grant. Subject to the terms and conditions set forth in this Agreement, Harvard hereby grants to Licensee an exclusive, worldwide, royalty-bearing license under the Patent Rights, solely to research, develop, make, have made, use, sell, offer for sale, have sold, export and import Licensed Products solely for use within the Field; provided, however, that:

2.1.1. Harvard retains the right, for itself, the Institutions, and for other not-for-profit research organizations, to practice the Patent Rights within the scope of the license granted above, solely for research, educational and scholarly purposes, and for Patient Treatment Purposes by Institutions’ clinical affiliates; provided, that such retained rights shall not include the right to grant any license, sublicense or option right in or to the Patent Rights to make, have made, sell, offer for sale, have sold, export or import products for use within the Field to any third party for-profit or commercial entity; and

2.1.2. the United States federal government retains rights in the Patent Rights pursuant to 35 U.S.C. §§ 200-212 and 37 C.F.R. § 401 et seq., and any right granted in this Agreement greater than that permitted under 35 U.S.C. §§ 200-212 or 37 C.F.R. § 401 et seq. will be subject to modification as may be required to conform to the provisions of those statutes and regulations.

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2.2. Affiliates. The license granted to Licensee under Section 2.1 includes the right to have some or all of Licensee’s rights or obligations under this Agreement exercised or performed by one or more of Licensee’s Affiliates, solely on Licensee’s behalf; provided, however, that:

2.2.1. no such Affiliate shall be entitled to grant, directly or indirectly, to any third party any right of whatever nature under, or with respect to, or permitting any use or exploitation of, any of the Patent Rights, including any right to develop, manufacture, market or sell Licensed Products; and

2.2.2. any act or omission taken or made by an Affiliate of Licensee under this Agreement will be deemed an act or omission by Licensee under this Agreement.

2.3. Sublicenses.

2.3.1. Sublicense Grant. Licensee will be entitled to grant Sublicenses to Third Parties under the licenses granted pursuant to clause (a) of Section 2.1, subject to the terms of this Section 2.3; provided, that, [***]. Such Sublicenses shall include the right to grant further Sublicenses through any number of tiers. All Sublicenses shall be subject to the terms of this Section 2.3, and otherwise on terms and conditions in compliance with and not inconsistent with the terms of this Agreement.

2.3.2. Sublicense Agreements. Licensee shall grant sublicenses pursuant to written agreements, which will be subject and subordinate to the terms and conditions of this Agreement. Such Sublicense agreements will contain, among other things, the following:

2.3.2.1. all provisions necessary to ensure Licensee’s ability to perform its obligations under this Agreement;

2.3.2.2. a section substantially the same as Article 9 of this Agreement, which also will state that the Indemnitees (as defined in Section 9.1) are intended third party beneficiaries of such Sublicense agreement for the purpose of enforcing such indemnification;

2.3.2.3. a provision clarifying that, in the event of termination of the license set forth in Section 2.1 (in whole or in part (e.g., termination in a particular country)), any existing Sublicense agreement shall terminate to the extent of such terminated license; provided that such Sublicensee shall have the right to enter into a direct license with Harvard under the terms set forth in Section 10.3.1 so long as such Sublicensee is in good standing under such Sublicense agreement and has not otherwise caused a material breach under this Agreement;

2.3.2.4. a provision clarifying that the Sublicensee shall only be entitled to sublicense its rights under such Sublicense agreement on the terms set forth in this Section 2.3; and

2.3.2.5. a provision prohibiting the Sublicensee from assigning the Sublicense agreement without the prior written consent of Harvard, except that Sublicensee may assign the Sublicense agreement to an Affiliate of such Sublicensee or to a successor in connection with the merger, consolidation or reorganization of such Sublicensee, or the sale of all or substantially all of its assets or that portion of its business to which the Sublicense agreement relates; provided, however, that any permitted assignee agrees in writing to be bound by the terms of such Sublicense agreement.

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2.3.3. Delivery of Sublicense Agreement. Licensee shall furnish Harvard with a fully executed copy of any Sublicense agreement, promptly after its execution. Harvard shall keep all such copies in its confidential files and shall use them solely for the purpose of monitoring Licensee’s and Sublicensees’ compliance with their obligations hereunder and enforcing Harvard’s rights under this Agreement.

2.3.4. Breach by Sublicensee. Licensee shall be responsible for any breach of a Sublicense agreement by any Sublicensee that results in or would have constituted a material breach of this Agreement had it been an act or omission by Licensee. Licensee shall either (a) cure such breach in accordance with Section 10.2.2 of this Agreement or (b) enforce its rights by terminating such Sublicense agreement in accordance with the terms thereof.

2.4. Option to Improvements.

2.4.1. Harvard shall promptly provide Licensee with written notice of each Improvement of which it becomes aware, and Licensee agrees to keep the contents of any such notice confidential, and shall not share any such information with any third party without Harvard’s prior written consent. With respect to such Improvement, Licensee shall have the right to request, in writing and delivered to Harvard by Licensee within [***] days following Licensee’s receipt of Harvard’s notice, an option to negotiate a license under Harvard’s interest in any patent application Harvard controls to the extent that such Improvement is Covered in such patent application (the “Improvement Patent Rights”).

2.4.2. If Licensee notifies Harvard in accordance with Section 2.5.1 above, Licensee shall provide to Harvard, within [***] days following Harvard’s receipt of Licensee’s notice, a development plan for Licensed Products covered by the Improvement Patent Rights (which shall include specific development milestones), for Harvard’s review and approval, not to be unreasonably withheld.

2.4.3. Subject to (i) any legal or contractual obligations of Harvard to Third Parties, but with the understanding that Harvard otherwise shall be obligated to offer such Improvement Patent Rights to Company first for licensing, and (ii) the agreement of each of the inventors of such Improvement, upon the date of Harvard’s approval of Licensee’s development plan, the Parties shall enter into negotiations for a period of up to [***] days (the “Amendment Negotiation Period”) to amend this Agreement to include a grant of rights under Harvard’s interest in the Improvement Patent Rights in the Field upon commercially reasonable financial terms (including, for example, an upfront fee, maintenance fees, milestone payments, etc.). [***].

2.5. No Other Grant of Rights. Except as expressly provided herein, nothing in this Agreement will be construed to confer any ownership interest, license or other rights upon Licensee by implication, estoppel or otherwise as to any technology, intellectual property rights, products or biological materials of Harvard, or any other entity, regardless of whether such technology, intellectual property rights, products or biological materials are dominant, subordinate or otherwise related to any Patent Rights.

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3. Development and Commercialization.

3.1.1. General. Licensee shall use Commercially Reasonable Efforts and shall cause its Sublicensees to use Commercially Reasonable Efforts: (a) to develop Licensed Products in accordance with the Development Plan; (b) and, to introduce at least two (2) Licensed Products into the commercial market; and (c) to market at least two (2) Licensed Products following such introduction into the market. For clarity, such Licensed Products shall consist of at least one Licensed Product for Conditioning, and at least one Licensed Product for Mobilization. In addition, Licensee, by itself or through its Affiliates or Sublicensees, shall achieve each of the Development Milestones within the time periods specified in Exhibit 1.5. For purposes of this Agreement, “Conditioning” shall mean depletion or ablation of endogenous hematopoietic stem cells and/or progenitor cells in a target tissue, and “Mobilization” shall mean mobilization of hematopoietic stem cells and/or progenitor cells for transplantation.

3.2. Adjustments of Development Plan. Licensee will be entitled, from time to time, to make such adjustments to the then applicable Development Plan as Licensee believes, in its good faith judgment, are needed in order to improve Licensee’s ability to meet the Development Milestones.

3.3. Reporting. Within [***] days after the end of each calendar year, Licensee shall furnish Harvard with a written report summarizing its, its Affiliates’ and its Sublicensees’ efforts during the prior year to develop and commercialize Licensed Products, including: (a) research and development activities; (b) commercialization and/or other distribution efforts; and (c) marketing efforts. Each report must contain a sufficient level of detail for Harvard to assess whether Licensee is in compliance with its obligations under Section 3.1 and a discussion of intended efforts for the then current year. Together with each report, Licensee shall provide Harvard with a copy of the then current Development Plan.

3.4. Failure to Meet Development Milestone; Opportunity to Cure. If Licensee believes that it will not achieve a Development Milestone, it may notify Harvard in writing in advance of the relevant deadline. Licensee shall include with such notice (a) a reasonable explanation of the reasons for such failure (and lack of finances will not constitute reasonable basis for such failure) (“Explanation”) and (b) a reasonable, detailed, written plan for promptly achieving a reasonable extended and/or amended milestone (“Plan”). If Licensee so notifies Harvard, but fails to provide Harvard with both an Explanation and Plan, then Licensee will have [***] to meet such Development Milestone. [***]. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, both of which are reasonably acceptable to Harvard in its good-faith reasonable discretion, then Exhibit 1.5 will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Explanation is not reasonably acceptable to Harvard in its good-faith reasonable discretion (e.g., but excluding Licensee asserting lack of finances or development preference for a non-Licensed Product without other reasons or factors to be considered), then Licensee will have [***] to meet such Development Milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement immediately upon written notice to Licensee. If Licensee so notifies Harvard and provides Harvard with an Explanation and Plan, but the Plan is

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not reasonably acceptable to Harvard in its good-faith reasonable discretion, then Harvard will explain to Licensee why the Plan is not acceptable and provide Licensee with suggestions for an acceptable Plan. Licensee will have one opportunity to provide Harvard with an acceptable Plan within [***] days, during which time Harvard agrees to work with Licensee in its effort to develop an acceptable Plan. If, within such [***] days, Licensee provides Harvard with an acceptable Plan, then Exhibit 1.5 will be amended automatically to incorporate the extended and/or amended milestone set forth in the Plan. If, within such [***] days, Licensee fails to provide an acceptable Plan, then Licensee will have an additional [***] days or until the original deadline of the relevant Development Milestone, whichever is later, to meet such Development Milestone. Licensee’s failure to do so shall constitute a material breach of this Agreement and Harvard shall have the right to terminate this Agreement immediately upon written notice to Licensee. For clarity, if Licensee fails to achieve a Development Milestone and does not avail itself of the procedure set forth in this Section 3.4, such failure shall be a material breach that entitles Harvard to proceed under Section 10.2.2.1.

4. Consideration for Grant of License.

4.1. License Issuance Fee. Licensee shall pay Harvard a non-refundable license fee of Eighty Five Thousand U.S. Dollars ($85,000), due and payable within thirty (30) days after the Effective Date.

4.2. Equity.

4.2.1. Issuance.

As partial consideration for the license granted hereunder and pursuant to a mutually-agreeable stock purchase or subscription agreement, within [***] days after the Effective Date, Licensee shall issue directly to Harvard, MGH and Children’s, collectively, 995,000 shares of Licensee’s common stock, representing [***] of Licensee’s capital stock on a Fully Diluted Basis (as defined below) after giving effect to such issuance. Licensee shall issue to each Institution that number of shares set forth beside such Institution’s name in Exhibit 4.2.1 hereto. If Licensee issues more than an aggregate of [***] of its Series A Preferred Stock, then, until Licensee has issued Series A Preferred Stock in exchange for an aggregate of [***] of cash investment, Licensee shall issue an additional number of shares of Licensee’s common stock to the Institutions in proportion to their stockholdings in Licensee, as necessary to cause the Institutions’ collective equity ownership to equal [***] of the issued and outstanding capital stock of Licensee calculated on a Fully Diluted Basis, (any such grant of additional shares of common stock, the “Anti-Dilution Adjustment”). All shares of common stock issued to the Institutions pursuant to the two foregoing sentences are referred to herein as the “Shares.” In no event shall the Anti-Dilution Adjustment result in the Institutions receiving additional shares of common stock as a result of Licensee issuing shares of preferred stock that are not shares of its Series A Preferred Stock. For purposes of this Section 4.2, “Fully Diluted Basis” shall mean, as of a specified date, the number of shares of common stock of Licensee then-outstanding (assuming conversion of all outstanding stock other than common stock into common stock), plus the number of shares of common stock of Licensee issuable upon exercise or conversion of then-outstanding convertible securities, options, rights or warrants of Licensee (which shall be determined without regard to whether such securities are then vested, exercisable or convertible), plus the number of shares of common stock of Licensee that would be outstanding or acquirable, directly or indirectly, upon the issuance (and exercise, conversion or exchange, if applicable) of

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all securities reserved or otherwise intended for future issuance under any stock purchase, stock option or other compensatory benefit plan or arrangement of Licensee; and “Series A Preferred Stock” shall mean those shares of preferred stock of Licensee issued, in one or more tranches, in exchange for investment of up to [***], pursuant to that certain Series A Preferred Stock Purchase Agreement entered into by Licensee on or about the Effective Date of this Agreement, which agreement shall be in form and substance substantially the same as that draft provided to Harvard by Licensee prior to the Effective Date. Licensee represents and warrants that the Shares have the rights and obligations set forth in the Certificate of Incorporation and Bylaws of Licensee in effect as of the effective date of the Series A Preferred Stock Purchase Agreement, which such documents shall be in the same form, without modification, amendment or supplement, as those provided to Harvard prior to the Effective Date. Harvard shall become a party to the Stockholders Agreement entered into in connection with the issuance of the Series A Preferred Stock for purposes of the board composition section and the drag-along right. In connection with the issuance of the Series A Preferred Stock, each Institution shall have the right to review and enter into any agreement (e.g., stockholders agreement, investors rights agreement, right of first refusal and co-sale agreement, etc.) to the same extent that any other owner of common stock of Licensee has such rights regarding any such agreement.

4.2.2. Representations and Warranties. Licensee represents and warrants to the Institutions that, upon each issuance of the Shares:

4.2.2.1. the pro forma capitalization table as attached at Exhibit 4.2.2.1 reflecting the initial issuance of Shares pursuant to Section 4.2.1, and as updated and provided to Harvard by Licensee upon issuance of any additional Shares in connection with an Anti-Dilution Adjustment, as the case may be (the “Cap Table”), sets forth all of the capital stock of Licensee on a Fully-Diluted Basis as of the date of issuance of such Shares;

4.2.2.2. other than as set forth in the Cap Table, as attached hereto at Exhibit 4.2.2.1 as of the Effective Date, and as updated as of the date of each issuance of the Shares, there are no outstanding shares of capital stock, convertible securities, outstanding warrants, options or other rights to subscribe for, purchase or acquire from Licensee any capital stock of Licensee and there are no contracts or binding commitments providing for the issuance of, or the granting of rights to acquire, any capital stock of Licensee or under which Licensee is, or may become, obligated to issue any of its securities; and

4.2.2.3. the Shares, when issued pursuant to the terms hereof, shall, upon such issuance, be duly authorized, validly issued, fully paid and nonassessable.

4.3. Annual License Maintenance Fees. Licensee shall pay Harvard annual license maintenance fees as follows:

4.3.1. Twenty Five Thousand U.S. Dollars ($25,000) for calendar year 2016, to be pro-rated in proportion to the remaining period of the calendar year following the Effective Date;

4.3.2. Twenty Five Thousand U.S. Dollars ($25,000) for each of calendar years 2017, 2018 and 2019;

4.3.3. Fifty Thousand U.S. Dollars ($50,000) for calendar year 2020 and each subsequent calendar year during the Term.

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Each such fee shall be due and payable on January 15th of the calendar year to which such fee applies.

Each annual license maintenance fee shall be creditable against any royalty amounts payable under Section 4.5 below with respect to Licensed Products sold in the same calendar year that such annual license maintenance fee was due.

4.4. Milestone Payments.

4.4.1. Licensee shall pay Harvard the following milestone payments with respect to only the first two Licensed Products under this Agreement to reach each milestone, regardless of whether such milestone is achieved by Licensee or any Affiliate, Sublicensee or licensee of Licensee. The amounts shown below are applicable for Type I Licensed Products, and the applicable milestone payments shall each be reduced by [***] in the case of any Type II Licensed Product:

4.4.1.1. [***];

4.4.1.2. [***];

4.4.1.3. [***];

4.4.1.4. [***];

4.4.1.5. [***]; and

4.4.1.6. [***].

4.4.2. Licensee shall notify Harvard in writing within [***] days following the achievement of each milestone described in Section 4.3.1, and shall make the appropriate milestone payment within [***] days after the achievement of such milestone.

4.4.3. The milestones set forth in Section 4.4.1.1-4.4.1.3 are intended to be successive. If a Licensed Product is not required to undergo the event associated with a particular milestone for a Licensed Product (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the achievement by such Licensed Product of the next successive milestone set forth in Section 4.4.1.1-4.4.1.3 or any milestone set forth in Sections 4.4.1.4-4.4.1.6 (“Achieved Milestone”). Payment for any Skipped Milestone that is owed in accordance with the provisions of this Section 4.4 shall be due within [***] days after the achievement of the Achieved Milestone.

4.4.4. If Licensee or any of its Affiliates receives Non-Royalty Income with respect to the achievement of any milestone listed in Section 4.4.1, such amounts payable by Licensee to Harvard under this Section 4.4 with respect to such milestone may be deducted from the aggregate amount of Non-Royalty Income on which Licensee must pay fees to Harvard under Section 4.6.

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4.5. Royalty on Net Sales.

4.5.1. Type I Licensed Product Rate. Licensee shall pay Harvard an amount equal to [***] of Net Sales of Type I Licensed Products on a country-by-country basis made at any time prior to the expiration of the last to expire Valid Claim in the applicable country covering or claiming the composition, manufacture, sale or use of such Type I Licensed Product.

4.5.2. Type II Licensed Product Rate. Licensee shall pay Harvard an amount equal to [***] of Net Sales of Type II Licensed Products on a country-by-country basis for a period of twelve (12) years from the date of the First Commercial Sale of such Licensed Product in such country (each, a “Type II Royalty Period”). For clarity, the Parties hereby agree that if a Licensed Product ceases to be a Type I Licensed Product in such country due to expiration of Patent Rights prior to the end of the twelve-year period following First Commercial Sale of such Licensed Product in such country, such Licensed Product shall thereafter be subject to the royalty terms set forth in this Section 4.5.2 regarding Type II Licensed Products, and Licensee will pay Harvard royalties on Net Sales of such Licensed Product in accordance with this Section 4.5.2, until the expiration of the applicable twelve-year period, measured as twelve (12) years from the date of the First Commercial Sale of such Licensed Product in such country.

4.5.3. Third Party Royalty Set-Off. If Licensee obtains a license from a third party to an Infringed Patent or a license from a third party to any Infringed Patent that is licensed together with any other pending or issued patents or know-how after arm’s length negotiations, it may offset [***] of any running royalty payments due thereunder with respect to sales of Type I Licensed Products that, without such third party license would infringe such Infringed Patent, against the royalty payments that are due to Harvard with respect to Net Sales of such Type I Licensed Products, on a country-by-country basis; provided that in no event shall (a) the royalty payments to Harvard with respect to such Type I Licensed Products be reduced by more than [***] of the amount otherwise due (i.e. an effective [***] royalty rate), and (b) the percentage offset that Licensee is entitled to make against royalty payments due to Harvard be greater than any percentage offset that Licensee is entitled to make against royalty payments due to such third party licensor on account of royalty payments made to Harvard with respect to such Type I Licensed Product.

4.5.4. Patent Challenge. If Licensee, its Affiliate or a Sublicensee (“Challenging Party”) commences a legal action in which it challenges the validity, enforceability or scope of any of the Patent Rights (a “Challenge Proceeding”), the royalty rate specified in Sections 4.5.1 and 4.5.2 will be doubled with respect to Net Sales of Licensed Products that are sold during the pendency of such Challenge Proceeding. If the outcome of such Challenge Proceeding is a determination against the Challenging Party, (a) the royalty rate specified in Sections 4.5.1 with respect to Net Sales of Licensed Products that are covered by the Patent Rights that are the subject of such Challenge Proceeding shall remain at such doubled rate and (b) Licensee shall reimburse Harvard for all expenses incurred by Harvard (including reasonable attorneys’ fees) in connection with such Challenge Proceeding. If the outcome of such Challenge Proceeding is a determination in favor of the Challenging Party, Licensee will have no right to recoup any royalties paid before or during the pendency of such Challenge Proceeding.

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4.5.5. Bad Debt. If, after exercising good faith, commercially reasonable collection efforts for at least two Calendar Quarters after the Calendar Quarter in which Net Sales are made for which Licensee is unable to collect any amount that it has billed or invoiced with respect to such Net Sales for which it has already paid royalties under Sections 4.5.1 or 4.5.2, Licensee shall be entitled to deduct the amount of such royalties with respect to such uncollected amount from the royalty payments due under Sections 4.5.1 and 4.5.2 in the next succeeding (third) Calendar Quarter, which deduction shall be set forth in the corresponding report under Section 5.1 below. If, at any time after such deduction Licensee does collect on the Net Sales for which such deduction was made, such collected amount shall be included as Net Sales in the Calendar Quarter in which they are collected and Licensee shall pay Harvard royalties thereon accordingly.

4.6. Non-Royalty Income. Licensee will pay Harvard an amount equal to (a) [***] of all Non-Royalty Income derived under Sublicenses and Strategic Partnerships entered into prior to the submission of the first IND for a Licensed Product, (b) [***] of all Non-Royalty Income derived under Sublicenses and Strategic Partnerships entered into after submission of the first IND for a Licensed Product and before enrollment of the first patient in a Phase 2 Clinical Trial, and (c) [***] of all Non-Royalty Income derived under Sublicenses and Strategic Partnerships entered into after enrollment of the first patient in a Phase 2 Clinical Trial. For clarity, this section and the requirements for the payment of Non-Royalty Income shall not apply to any M&A Transactions.

5. Reports; Payments; Records.

5.1. Reports and Payments.

5.1.1. Reports. Within [***] days after the conclusion of each Calendar Quarter commencing with the first Calendar Quarter in which Net Sales are generated or Non-Royalty Income is received, Licensee shall deliver to Harvard a report containing the following information (in each instance, with a Licensed Product-by-Licensed Product and country-by-country breakdown):

5.1.1.1. [***];

5.1.1.2. [***];

5.1.1.3. [***];

5.1.1.4. [***];

5.1.1.5. [***]; and

5.1.1.6. [***].

Each such report shall be certified on behalf of Licensee as true, correct and complete in all material respects. If no amounts are due to Harvard for a particular Calendar Quarter, the report shall so state.

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5.1.2. Payment. Within [***] days after the end of each Calendar Quarter, Licensee shall pay Harvard all amounts due with respect to Net Sales and Non-Royalty Income for the applicable Calendar Quarter.

5.2. Payment Currency. All payments due under this Agreement will be paid in U.S. Dollars. Conversion of foreign currency to U.S. Dollars will be made at the conversion rate existing in the United States (as reported in the Wall Street Journal) on the last working day of the applicable Calendar Quarter. Such payments will be without deduction of exchange, collection or other charges.

5.3. Records. Licensee shall maintain, and shall cause its Affiliates and Sublicensees to maintain, complete and accurate records of Licensed Products that are made, used, sold, leased or transferred under this Agreement, any amounts payable to Harvard in relation to such Licensed Products, and all Non-Royalty Income received by Licensee and its Affiliates, which records shall contain sufficient information to permit Harvard to confirm the accuracy of any reports or notifications delivered to Harvard under Section 5.1. Licensee, its Affiliates and/or its Sublicensees, as applicable, shall retain such records relating to a given Calendar Quarter for at least [***] years after the conclusion of that Calendar Quarter, during which time Harvard will have the right, at its expense, to cause an independent, certified public accountant (or, in the event of a non-financial audit, other appropriate auditor) to inspect such records during normal business hours for the purposes of verifying the accuracy of any reports and payments delivered under this Agreement and Licensee’s compliance with the terms hereof. Such accountant or other auditor, as applicable, shall not disclose to Harvard any information other than information relating to the accuracy of reports and payments delivered under this Agreement. The parties shall reconcile any underpayment or overpayment within [***] days after the accountant delivers the results of the audit. If any audit performed under this Section 5.3 reveals an underpayment in excess of [***] in any calendar year, Licensee shall reimburse Harvard for all amounts incurred in connection with such audit. Harvard may exercise its rights under this Section 5.3 [***] and only with reasonable prior notice to the audited entity.

5.4. Late Payments. Any payments by Licensee that are not paid on or before the date such payments are due under this Agreement will bear interest at the lower of (a) [***] per month and (b) the maximum rate allowed by law. Interest will accrue beginning on the first day following the due date for payment and will be compounded quarterly. Payment of such interest by Licensee shall not limit, in any way, Harvard’s right to exercise any other remedies Harvard may have as a consequence of the lateness of any payment.

5.5. Payment Method. Each payment due to Harvard under this Agreement shall be paid by check or wire transfer of funds to Harvard’s account in accordance with written instructions provided by Harvard. If made by wire transfer, such payments shall be marked so as to refer to this Agreement.

5.6. Withholding and Similar Taxes. All amounts to be paid to Harvard pursuant to this Agreement shall be without deduction of exchange, collection, or other charges, and, specifically, without deduction of withholding or similar taxes or other government imposed fees or taxes, except as permitted in the definition of Net Sales.

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5.7. Licensee acknowledges that policies of the Institutions and affiliated organizations, relating to, inter alia, conflicts of interest and intellectual property, may affect certain direct and indirect arrangements between inventors and Licensee or related organizations. During the Term, to the extent Licensee becomes actually aware, Licensee shall notify the inventor’s Institution in writing at least [***] days before, or immediately thereafter if Licensee or its subsidiaries plans to enter or enters into any agreement other than this Agreement with or involving the inventors of the Patent Rights, or members or staff of their respective laboratories, whether relating to sponsored research, consulting, board membership, securities, or otherwise. Licensee’s notice to each such Institution shall include a detailed description of all proposed terms and conditions. Licensee shall not enter into such an agreement if it would violate such policies unless the terms and conditions of the agreement have been duly approved by the applicable Institution or its Affiliates pursuant to such policies.

6.1. Control. Harvard will be responsible for the preparation, filing, prosecution, protection, defense and maintenance of all Patent Rights, using independent patent counsel reasonably acceptable to Licensee. Harvard will: (a) instruct such patent counsel to furnish the Licensee with copies of all correspondence and office actions relating to the Patent Rights from or with the United States Patent and Trademark Office (USPTO) and any other patent office, as well as copies of all proposed responses to such correspondence and office actions in time for Licensee to review and provide comments and input on such response; (b) give Licensee an opportunity to review and provide comments and input on the text of each patent application before filing; (c) consult with Licensee with respect thereto; (d) supply Licensee with a copy of the application as filed, together with notice of its filing date and serial number; and (e) keep Licensee advised of the status of actual and prospective patent filings. Harvard shall give Licensee the opportunity to provide comments and input on and make requests of Harvard concerning the preparation, filing, prosecution, protection, defense and maintenance of the Patent Rights, and shall seriously consider all such comments, input and requests; however, final decision-making authority shall vest in Harvard.

6.2. Expenses. Subject to Section 6.3 below, Licensee shall reimburse Harvard for all documented, out-of-pocket expenses incurred by the Institutions after the Effective Date pursuant to this Article 6 (“Ongoing Patent Expenses”) within [***] days after the date of each invoice from Harvard for such expenses. In addition, within [***] days after the Effective Date, Licensee shall reimburse Harvard for all documented, out-of-pocket expenses incurred by the Institutions prior to the Effective Date with respect to the preparation, filing, prosecution, protection and maintenance of Patent Rights (“Back Patent Expenses”), as well as an amount equal to [***] as reimbursement for out of pocket costs incurred by Harvard in connection with inventorship analysis regarding certain Patent Rights. As of the Effective Date, such Back Patent Expenses total approximately [***]. For purposes of this Section 6.2, expenses with respect to the preparation, filing, prosecution, protection and maintenance of Patent Rights authorized prior to the Effective Date for which Harvard has not yet received a bill from outside counsel as of the Effective Date shall be deemed incurred after the Effective Date and included in Ongoing Patent Expenses.

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6.3. Abandonment. If Licensee decides that it does not wish to pay for the preparation, filing, prosecution, protection or maintenance of any Patent Rights in a particular country (“Abandoned Patent Rights”), Licensee shall provide Harvard with prompt written notice of such election. Upon receipt of such notice by Harvard, Licensee shall be released from its obligation to reimburse Harvard for the expenses incurred thereafter as to such Abandoned Patent Rights; provided, however, that expenses authorized prior to the receipt by Harvard of such notice shall be deemed incurred prior to the notice. In the event of Licensee’s abandonment of any Patent Rights, any license granted by Harvard to Licensee hereunder with respect to such Abandoned Patent Rights will terminate, and Licensee will have no rights whatsoever to exploit such Abandoned Patent Rights. Harvard will then be free, without further notice or obligation to Licensee, to grant rights in and to such Abandoned Patent Rights to third parties.

6.4. Small Entity Designation. If Licensee, its Affiliates, any Sublicensee and/or any holder of an option to obtain a Sublicense does not qualify, or at any point during the Term ceases to qualify, as an entity entitled to pay lesser fees as provided by the USPTO (i.e., a “small entity”) or the patent office of any other country, Licensee shall so notify Harvard immediately, in order to enable Harvard to comply with regulations regarding payment of fees with respect to Patent Rights..

6.5. Marking. Licensee shall, and shall cause its Affiliates and Sublicensees to, mark all Licensed Products sold or otherwise disposed of in such a manner as to conform with the patent laws and practice of the country to which such products are shipped or in which such products are sold for purposes of ensuring maximum enforceability of Patent Rights in such country.

7. Enforcement of Patent Rights.

7.1. Notice. In the event either party becomes aware of any possible or actual infringement of any Patent Rights with respect to Licensed Products in the Field (an “Infringement”), that party shall promptly notify the other party and provide it with details regarding such Infringement.

7.2. Suit by Licensee. Licensee shall have the first right, but not the obligation, to take action in the prosecution, prevention, or termination of any Infringement. Before Licensee commences an action with respect to any Infringement, Licensee shall consider in good faith the views of the Institutions and potential effects on the public interest in making its decision whether to take such action. Should Licensee elect to bring suit against an infringer, Licensee shall keep the Institutions reasonably informed of the progress of the action and shall give each Institution a reasonable opportunity in advance to consult with Licensee and offer its views about major decisions affecting the litigation. Licensee shall give careful consideration to those views, but shall have the right to control the action; provided, however, that if Licensee fails to defend in good faith the validity and/or enforceability of the Patent Rights in the action or, or if Licensee’s license to a Valid Claim in the suit terminates, Harvard may elect to take control of the action pursuant to Section 7.3. Any and all expenses, including reasonable attorneys’ fees, incurred by Harvard with respect to the prosecution, adjudication and/or settlement of such suit, including any related appeals, shall be paid for entirely by Licensee and Licensee shall hold Harvard free, clear and harmless from and against any and all such expenses. The expenses of

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such suit or suits that Licensee elects to bring, including any expenses of each Institution incurred in conjunction with the prosecution of such suits or the settlement thereof, shall be paid for entirely by Licensee and Licensee shall hold each Institution free, clear and harmless from and against any and all costs of such litigation, including reasonable attorneys’ fees. Licensee shall not compromise or settle such litigation without the prior written consent of each Institution, which consent shall not be unreasonably withheld or delayed. In the event Licensee exercises its right to sue pursuant to this Section 7.2, it shall first reimburse itself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including reasonable attorneys’ fees, necessarily incurred in the prosecution of any such suit. If, after such reimbursement, any funds shall remain from said recovery, then Harvard shall receive an amount equal to [***] of such funds and the remaining [***] of such funds shall be retained by Licensee.

7.3. Suit by Harvard. If Licensee does not take action in the prosecution, prevention, or termination of any Infringement pursuant to Section 7.2 above, and has not commenced negotiations with the infringer for the discontinuance of said Infringement, within ninety (90) days after receipt of notice to Licensee by Harvard of the existence of an Infringement, Harvard may elect to do so. Should Harvard elect to bring suit against an infringer and Licensee is joined as party plaintiff in any such suit, Licensee shall have the right to approve the counsel selected by Harvard to represent Harvard and Licensee, such approval not to be unreasonably withheld. Any and all expenses, including reasonable attorneys’ fees, incurred by Licensee with respect to the prosecution, adjudication and/or settlement of such suit, including any related appeals, shall be paid for entirely by Harvard and Harvard shall hold Licensee free, clear and harmless from and against any and all such expenses. Harvard shall not compromise or settle such litigation without the prior written consent of Licensee, which consent shall not be unreasonably withheld or delayed. In the event Harvard exercises its right to sue pursuant to this Section 7.3, it shall first reimburse itself out of any sums recovered in such suit or in settlement thereof for all costs and expenses of every kind and character, including reasonable attorneys’ fees, necessarily incurred in the prosecution of any such suit. If, after such reimbursement, any funds shall remain from said recovery, then Licensee shall receive an amount equal to [***] of such funds and the remaining [***] of such funds shall be retained by Harvard.

7.4. Own Counsel. Each party shall always have the right to be represented by counsel of its own selection and at its own expense in any suit instituted under this Article 7 by the other party for Infringement.

7.5. Cooperation. Each party agrees to cooperate fully in any action under this Article 7 that is controlled by the other party, provided that the controlling party reimburses the cooperating party promptly for any costs and expenses incurred by the cooperating party in connection with providing such assistance.

7.6. Declaratory Judgment. If a declaratory judgment action is brought naming Licensee and/or any of its Affiliates or Sublicensees as a defendant and alleging invalidity or unenforceability of any claims within the Patent Rights, Licensee shall promptly notify each Institution in writing and the Institutions may elect, upon written notice to Licensee within thirty (30) days after they each receive notice of the commencement of such action, to take over the sole defense of the invalidity and/or unenforceability aspect of the action at its own expense.

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8.1. Compliance with Law. Licensee represents and warrants that it will comply, and will ensure that its Affiliates and Sublicensees comply, with all local, state, federal and international laws and regulations relating to the development, manufacture, use, sale and importation of Licensed Products. Without limiting the foregoing, Licensee represents and warrants, on behalf of itself and its Affiliates and Sublicensees, that it shall comply with all United States laws and regulations controlling the export of certain commodities and technical data, including without limitation all Export Administration Regulations of the United States Department of Commerce. Among other things, these laws and regulations prohibit or require a license for the export of certain types of commodities and technical data to specified countries. Licensee hereby gives written assurance that it will comply with, and will cause its Affiliates to comply with (and will contractually obligate its Sublicensees to comply with), all United States export control laws and regulations, that it bears sole responsibility for any violation of such laws and regulations by itself or its Affiliates or Sublicensees, and that it will indemnify, defend, and hold Harvard harmless (in accordance with Section 9.1) for the consequences of any such violation.

8.2. Limited Representation and Disclaimer of other Warranties.

8.2.1. (A) HARVARD HEREBY REPRESENTS TO LICENSEE THAT, AS OF THE EFFECTIVE DATE, TO THE ACTUAL KNOWLEDGE OF THE RESPONSIBLE LICENSING OFFICER(S) AT HARVARD’S OFFICE OF TECHNOLOGY DEVELOPMENT (“OTD”), WITHOUT ANY FURTHER INVESTIGATION OR FURTHER INQUIRY WITHIN HARVARD, HARVARD HAS NOT RECEIVED WRITTEN NOTICE OF ANY PENDING OR THREATENED LAWSUIT OR LEGAL PROCEEDING OR ACTION BY A THIRD PARTY ASSERTING THAT THE PATENT RIGHTS INFRINGE OR MISAPPROPRIATE THE INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY. IN THE EVENT THAT AFTER THE EFFECTIVE DATE, OTD RECEIVES SUCH WRITTEN NOTICE, IT SHALL NOTIFY LICENSEE PROMPTLY.

(B) NOTHING CONTAINED HEREIN SHALL BE DEEMED TO BE A WARRANTY BY HARVARD THAT IT CAN OR WILL BE ABLE TO OBTAIN PATENTS ON PATENT APPLICATIONS INCLUDED IN THE PATENT RIGHTS, OR THAT ANY OF THE PATENT RIGHTS WILL AFFORD ADEQUATE OR COMMERCIALLY WORTHWHILE PROTECTION.

8.2.2. HARVARD MAKES NO WARRANTIES WHATSOEVER AS TO THE COMMERCIAL OR SCIENTIFIC VALUE OF THE PATENT RIGHTS. HARVARD MAKES NO REPRESENTATION THAT THE PRACTICE OF THE PATENT RIGHTS OR THE DEVELOPMENT, MANUFACTURE, USE, SALE OR IMPORTATION OF ANY LICENSED PRODUCT, OR ANY ELEMENT THEREOF, WILL NOT INFRINGE ANY PATENT OR PROPRIETARY RIGHTS.

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8.2.3. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY, PATENTS, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY DISCLAIMS WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING.

8.3. Limitation of Liability.

8.3.1. Except with respect to matters for which Licensee is obligated to indemnify Harvard under Article 9, neither party will be liable to the other with respect to any subject matter of this Agreement under any contract, negligence, strict liability or other legal or equitable theory for (a) any indirect, incidental, consequential or punitive damages or lost profits or (b) cost of procurement of substitute goods, technology or services. In addition, neither MGH nor Children’s, or any of their respective trustees, directors, officers, medical and professional staff, employees and agents be liable to Licensee or any of its Affiliates, Sublicensees or distributors for indirect, special, incidental or consequential damages of any kind arising in any way out of this Agreement or the license rights granted hereunder, however caused and on any theory of liability, including without limitation economic damages or injury to property or lost profits, regardless of whether MGH or Children’s shall be advised, shall have other reason to know, or in fact shall know of the possibility of the foregoing.

8.3.2. Except with respect to Harvard’s obligations of confidentiality hereunder, or Harvard’s willful misconduct under this Agreement, Harvard’s aggregate liability for all damages of any kind arising out of or relating to this Agreement or its subject matter under any contract, negligence, strict liability or other legal or equitable theory shall not exceed the amounts paid to Harvard under this Agreement.

9. Indemnification and Insurance.

9.1. Indemnity.

9.1.1. Licensee shall indemnify, defend and hold harmless each of Harvard, Children’s and MGH and their current and former directors, governing board members, trustees, officers, faculty, medical and professional staff, employees, students, and agents and their respective successors, heirs and assigns (collectively, the “Indemnitees”) from and against any claim, liability, cost, expense, damage, deficiency, loss or obligation of any kind or nature (including reasonable attorneys’ fees and other costs and expenses of litigation), based upon, arising out of, or otherwise relating to the practice of any rights as granted by Harvard to Licensee under this Agreement by Licensee, any of its Affiliates or any Sublicensee under any Sublicense, including any cause of action relating to product liability concerning any product, process, or service made, used, sold or performed pursuant to any right or license granted from Harvard to Licensee under this Agreement (collectively, “Claims”), except to the extent that any such Claim is attributable to the gross negligence or willful misconduct of such Indemnitee or the breach by Harvard of any provision of this Agreement. Neither Licensee nor Harvard shall settle any Claim without the prior written consent of the other, which consent shall not be unreasonably withheld.

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9.1.2. Licensee shall, at its own expense, provide attorneys reasonably acceptable to the applicable Institution to defend against any actions brought or filed against any Indemnitee hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought.

9.2. Insurance.

9.2.1. Beginning at the time any Licensed Product is being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee, or by an Affiliate, Sublicensee or agent of Licensee, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $[***] per incident and $[***] annual aggregate and naming the Indemnitees as additional insureds. During clinical trials of any such Licensed Product, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in such equal or lesser amount as may be consistent with such prudent practices, but in any event no less than $[***] per incident and $[***] annual aggregate, naming the Indemnitees as additional insureds. Such commercial general liability insurance shall provide: (a) product liability coverage and (b) broad form contractual liability coverage for Licensee’s indemnification obligations under this Agreement.

9.2.2. If Licensee elects to self-insure all or part of the limits described above in Section 9.2.1 (including deductibles or retentions that are in excess of $[***] annual aggregate) such self-insurance program must be acceptable to Harvard and CRICO/RMF (Harvard’s insurer) in their reasonable discretion. The minimum amounts of insurance coverage required shall not be construed to create a limit of Licensee’s liability with respect to its indemnification obligations under this Agreement.

9.2.3. Licensee shall provide Harvard with written evidence of such insurance upon request of Harvard. Licensee shall provide Harvard with written notice at least [***] days prior to the cancellation, non-renewal or material change in such insurance. If Licensee does not obtain replacement insurance providing comparable coverage within such [***] day period, Harvard shall have the right to terminate this Agreement effective at the end of such [***] day period without notice or any additional waiting periods.

9.2.4. Licensee shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during: (a) the period that any Licensed Product is being commercially distributed or sold by Licensee, or an Affiliate, Sublicensee or agent of Licensee; and (b) a reasonable period after the period referred to in (a) above which in no event shall be less than [***] years.

10. Term and Termination.

10.1. Term. The term of this Agreement shall commence on the Effective Date and, unless earlier terminated as provided in this Article 10, shall continue in full force and effect until the later of (i) the expiration of the last to expire Valid Claim, and (ii) the expiration of the last Type II Royalty Period (the “Term”).

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10.2. Termination.

10.2.1. Termination Without Cause. Licensee may terminate this Agreement for any reason (or merely for convenience) upon [***] days prior written notice to Harvard.

10.2.2. Termination for Default.

10.2.2.1. In the event that either party commits a material breach of its obligations under this Agreement and fails to cure that breach within [***] days after receiving written notice thereof, the other party may terminate this Agreement immediately upon written notice to the party in breach.

10.2.2.2. If Licensee defaults in its obligations under Section 9.2 to procure and maintain insurance or, if Licensee has in any event failed to comply with the notice requirements contained therein, then Harvard may terminate this Agreement immediately without notice or additional waiting period.

10.2.2.3. Harvard shall be entitled to terminate this Agreement in accordance with the provisions of Section 3.4.

10.2.3. Bankruptcy. Harvard may terminate this Agreement upon notice to Licensee if Licensee becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial settlement with its creditors, makes an assignment for the benefit of its creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the like) in bankruptcy appointed by reason of its insolvency, or in the event an involuntary bankruptcy action is filed against Licensee and not dismissed within [***] days, or if Licensee becomes the subject of liquidation or dissolution proceedings or otherwise discontinues business.

10.3. Effect of Termination.

10.3.1. Termination of Rights. Upon expiration or termination of this Agreement by either party pursuant to any of the provisions of Section 10.2: (a) the rights and licenses granted to Licensee under Article 2 shall terminate, all rights in and to and under the Patent Rights will revert to Harvard and neither Licensee nor its Affiliates may make any further use or exploitation of the Patent Rights; and (b) any existing agreements that contain a Sublicense shall terminate to the extent of such Sublicense; provided, however, that, notwithstanding the foregoing, each Sublicensee that is not at that time in breach of its Sublicense shall have the right to obtain a license from Harvard on substantially the same terms and conditions as set forth herein, which shall not impose any representations, warranties, obligations or liabilities on Harvard that are not included in this Agreement; provided, that (i) the scope of the license granted directly by Harvard to such Sublicensee shall be co-extensive with the scope of the Sublicense granted by Licensee to such Sublicensee, (ii) if the Sublicense granted to such Sublicensee was non-exclusive, such Sublicensee shall not have the right to participate in the prosecution or enforcement of the Patent Rights under the license granted to it directly by Harvard, (iii) if there is more than one Sublicensee, each Sublicensee that is granted a direct license shall be responsible for a pro rata share of the reimbursement due under Section 6.2 of this Agreement (based on the number of direct licenses under the Patent Rights in effect on the date of reimbursement), (iv) the financial terms of such direct license by Harvard shall be

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no less favorable to Harvard than the financial terms that apply to Licensee under this Agreement, (v) Harvard shall not have any obligations that are greater than or inconsistent with the obligations of Harvard under this Agreement or the nature of Harvard as an academic and non-profit entity, or any fewer rights than Harvard has under this Agreement, and (vi) all obligations arising prior to execution of such direct license shall remain the responsibility of Licensee and Harvard shall be released from any and all liability relating to such obligations. If any Sublicensee desires to enter into such a direct license, it shall be wholly the responsibility of that Sublicensee to notify Harvard of such desire no later than [***] days after the effective date of termination of this Agreement.

10.3.2. Accruing Obligations. Termination or expiration of this Agreement shall not relieve the parties of obligations accruing prior to such termination or expiration, including obligations to pay amounts accruing hereunder up to the date of termination or expiration. After the date of termination or expiration (except in the case of termination by Harvard pursuant to Section 10.2), Licensee, its Affiliates and Sublicensees (a) may sell Licensed Products then in stock and (b) may complete the production of Licensed Products then in the process of production and sell the same; provided that, in the case of both (a) and (b), Licensee shall pay the applicable royalties and payments to Harvard in accordance with Article 4, provide reports and audit rights to Harvard pursuant to Article 5 and maintain insurance in accordance with the requirements of Section 9.2. The parties agree that the obligations in Section 4.1 (License Fee), Section 4.2 (Equity) and Section 6.2 (Patent Expenses) will accrue immediately upon execution of this Agreement by both parties, regardless of the events, invoice and payment timing details set forth therein.

10.3.3. Regulatory Filings. Licensee shall have the exclusive right to prepare and present all regulatory filings necessary or appropriate in any country and to obtain and maintain any regulatory approval required to market Licensed Products in any such country. Licensee shall solely own all right, title and interest in and to all such regulatory approvals and filings; provided, however, that in the event Licensee terminates this Agreement pursuant to Section 10.2.1 or Harvard terminates this Agreement pursuant to any of the provisions of Section 10.2, Licensee and Harvard will, for a period of [***] days thereafter, exclusively negotiate in good faith for the terms to be applicable to a potential license or assignment agreement, under which Licensee would license or assign to Harvard and provide Harvard with the right to reference, cross-reference, review, have access to, incorporate and use all documents and other materials filed by or on behalf of Licensee and its Affiliates with any Regulatory Authority in furtherance of applications for regulatory approval in the relevant country with respect to Licensed Products; provided, however, that neither Party shall be under any obligation to enter into any such license or assignment agreement, and Licensee shall not be required to grant any such rights to Harvard unless the Parties enter into a mutually acceptable definitive agreement, at the sole discretion of each Party.

10.4. Survival. The parties’ respective rights, obligations and duties under Articles 5, 9, 10 and 11 and Sections 4.2, 4.5.2, 4.5.4, 8.2 and 8.3, as well as any rights, obligations and duties which by their nature extend beyond the expiration or termination of this Agreement, shall survive any expiration or termination of this Agreement. In addition, Licensee’s obligations under Section 4.6 with respect to Sublicenses granted and Strategic Partnerships entered into prior to expiration or termination of the Agreement shall survive such expiration or termination.

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11. Miscellaneous.

11.1. Preference for United States Industry. During the period of exclusivity of this license in the United States, Licensee shall comply with 37 C.F.R. § 401.14 (i) or any successor rule or regulation.

11.2. No Security Interest. Licensee shall not enter into any agreement under which Licensee grants to or otherwise creates in any third party a security interest in this Agreement or any of the rights granted to Licensee herein. Any grant or creation of a security interest purported or attempted to be made in violation of the terms of this Section 11.2 shall be null and void and of no legal effect.

11.3. Use of Name. Except as provided below, Licensee shall not, and shall ensure that its Affiliates and Sublicensees shall not, use or register the name of any Institution (alone or as part of another name) or any logos, seals, insignia or other words, names, symbols or devices that identify any Institution or any Institution school, unit, division or affiliate (“Institution Names”) for any purpose except with the prior written approval of, and in accordance with restrictions required by, the applicable Institution. Without limiting the foregoing, Licensee shall, and shall ensure that its Affiliates and Sublicensees shall, cease all use of Institution Names on the termination or expiration of this Agreement except as otherwise approved by each applicable Institution. This restriction shall not apply to any information required by law to be disclosed to any governmental entity.

11.4. Entire Agreement. This Agreement is the sole agreement with respect to the subject matter hereof and except as expressly set forth herein, supersedes all other agreements and understandings between the parties with respect to the same.

11.5. Notices. Unless otherwise specifically provided, all notices required or permitted by this Agreement shall be in writing and may be delivered personally, or may be sent by facsimile, expedited delivery or certified mail, return receipt requested, to the following addresses, unless the parties are subsequently notified of any change of address in accordance with this Section 11.5:

 	If to Licensee
(other than
invoices):	  	Magenta Therapeutics, Inc.
[***]
(invoices
only):	  	Magenta Therapeutics, Inc
[***]
 	If to Harvard:	  	
Office of Technology Development
Harvard University
[***]

Attn.: Chief Technology Development Officer

Any notice shall be deemed to have been received as follows: (a) by personal delivery or expedited delivery, upon receipt; (b) by facsimile, one business day after transmission or dispatch; (c) by certified mail, as evidenced by the return receipt. If notice is sent by facsimile, a confirming copy of the same shall be sent by mail to the same address.

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11.6. Governing Law and Jurisdiction. This Agreement will be governed by, and construed in accordance with, the substantive laws of the Commonwealth of Massachusetts, without giving effect to any choice or conflict of law provision, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent shall have been granted. Any action, suit or other proceeding arising under or relating to this Agreement (a “Suit”) shall be brought in a court of competent jurisdiction in the Commonwealth of Massachusetts, and the parties hereby consent to the sole jurisdiction of the state and federal courts sitting in the Commonwealth of Massachusetts. Each party agrees not to raise any objection at any time to the laying or maintaining of the venue of any Suit in any of the specified courts, irrevocably waives any claim that Suit has been brought in any inconvenient forum and further irrevocably waives the right to object, with respect to any Suit, that such court does not have any jurisdiction over such party.

11.7. Binding Effect. This Agreement shall be binding upon and inure to the benefit of the parties and their respective legal representatives, successors and permitted assigns.

11.8. Headings. Section and subsection headings are inserted for convenience of reference only and do not form a part of this Agreement.

11.9. Counterparts. The parties may execute this Agreement in two or more counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument. Transmission by facsimile or electronic mail of an executed counterpart of this Agreement shall be deemed to constitute due and sufficient delivery of such counterpart. If by electronic mail, the executed Agreement must be delivered in a .pdf format.

11.10. Amendment; Waiver. This Agreement may be amended, modified, superseded or canceled, and any of the terms may be waived, only by a written instrument executed by each party or, in the case of waiver, by the party waiving compliance. The delay or failure of either party at any time or times to require performance of any provisions hereof shall in no manner affect the rights at a later time to enforce the same. No waiver by either party of any condition or of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement.

11.11. No Agency or Partnership. Nothing contained in this Agreement shall give either party the right to bind the other, or be deemed to constitute either party as agent for or partner of the other or any third party.

11.12. Assignment and Successors. This Agreement may not be assigned by either party without the consent of the other, which consent shall not be unreasonably withheld, conditioned or delayed, except that Licensee may, without the consent of Harvard, assign this Agreement, in its entirety, and the rights, obligations and interests of Licensee hereunder (i) to any purchaser of all of the equity of Licensee, or (ii) to any successor corporation resulting from

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any merger or consolidation of Licensee with or into such corporation, or (iii) to any purchaser of all or substantially all of the assets of Licensee; provided, in each case, that the assignee agrees in writing to be bound by the terms of this Agreement. Any assignment purported or attempted to be made in violation of the terms of this Section 11.12 shall be null and void and of no legal effect. For clarity, a restructuring or reorganization of Licensee in which the stockholders of Licensee immediately before such transaction directly or indirectly beneficially own (as such term is used in Rule 13d-3 under the Securities Exchange Act of 1934, as amended), immediately thereafter, at least a majority of the outstanding equity of Licensee or the entity that acquires Licensee’s assets or stock shall not be deemed to be an assignment of this Agreement for any purpose hereunder.

11.13. Force Majeure. Except for monetary obligations hereunder, neither party will be responsible for delays resulting from causes beyond the reasonable control of such party, including fire, explosion, flood, war, strike, or riot, provided that the nonperforming party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.

11.14. Interpretation. Each party hereto acknowledges and agrees that: (a) it and/or its counsel reviewed and negotiated the terms and provisions of this Agreement and has contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved against the drafting party shall not be employed in the interpretation of this Agreement; (c) the terms and provisions of this Agreement shall be construed fairly as to both parties hereto and not in favor of or against either party, regardless of which party was generally responsible for the preparation of this Agreement; and (d) the use of “include,” “includes,” or “including” herein shall not be limiting and “or” shall not be exclusive.

11.15. Severability. If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it is the intention of the parties that the remainder of this Agreement shall not be affected.

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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the date first written above.

President and Fellows of Harvard College	  	Magenta Therapeutics, Inc.

By: /s/ Isaac T. Kohlberg                                                  	  	By: /s/ Jason Gardner                                                          
Name: Isaac T. Kohlberg	  	Name: Jason Gardner
Title: Senior Associate Provost

          Chief Technology Development Officer

          Office of Technology Development

          Harvard University

  	Title: CEO
Signature Page

Exhibit 1.5

Development Milestones

With respect to a Licensed Product for Mobilization:

Initiation of IND-enabling Preclinical Toxicology Study of a Licensed Product within [***] of the Effective Date;

Submission of an IND for a Licensed Product to [***] within [***] of the Effective Date;

Enrollment of the first subject in the first Phase 2 Clinical Study, within [***] of IND filing;

Enrollment of the first subject in the first Phase 3 Clinical Study of a Licensed Product within [***] after initiation of the first Phase 2 Clinical Study; and

Submission of a Licensed Product for Marketing Authorization in [***] within [***] from initiation of the first Phase 3 Clinical Study for such Licensed Product or [***] from the Effective Date.

With respect to a Licensed Product for Conditioning:

Enrollment of the first subject in the first Phase 3 Clinical Study of a Licensed Product within [***] initiation of the first Phase 2 Clinical Study; and

Submission of a Licensed Product for Marketing Authorization in [***] within [***] from initiation of the first Phase 3 Clinical Study for such Licensed Product or [***].

Exhibit 1.6

Development Plan

See attached.

[***]

[***]

Exhibit 1.18

Patent Rights

Harvard Case No.	  	
Application or Patent No.

Filing or Issue Date

Title

[***]	  	[***]	  	[***]	  	[***]

Exhibit 4.2.1

Initial Equity Issuance: Shares/Percentages

[***]

Exhibit 4.2.2.1

Capitalization Table

[***]

EX-10.1 2 d271369dex101.htm LICENSE AGREEMENT
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 10.1

THIS LICENSE AGREEMENT (“Agreement”) is entered into as of the 18th day of August, 2011 (the “Execution Date”), by and between Puma Biotechnology, Inc., a corporation organized and existing under the laws of Delaware with offices at 10940 Wilshire Blvd, Suite 600, Los Angeles, CA 90024 (“LICENSEE”) and Pfizer Inc., a corporation organized and existing under the laws of Delaware with offices at 235 East 42nd Street, New York, NY 10017 (“PFIZER”), on its own behalf and on behalf of its Affiliates. LICENSEE and PFIZER may, from time-to-time, be individually referred to as a “Party” and collectively referred to as the “Parties”.

RECITALS

WHEREAS, PFIZER controls, directly or through its affiliates, certain technology relating to a compound known as neratinib, and is conducting Phase III clinical trials of such compound for the treatment of cancer; and

WHEREAS, LICENSEE wishes to obtain, and PFIZER wishes to grant, at the Closing (as defined below) certain licenses under such technology for the development, manufacture and commercialization of neratinib worldwide, on the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual agreements and covenants set forth herein and other good and valuable consideration, the receipt and sufficiency of which the Parties hereby acknowledge, the Parties, intending to be legally bound hereby, agree to the foregoing and as follows:

1.	DEFINITIONS

1.1.	“Affiliate” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall refer to: (a) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through the ownership of voting securities, by contract or otherwise, or (b) the ownership, directly or indirectly, of fifty percent (50%) or more of the voting securities of such entity.
 
 	1.2.	“Applicable Laws” means all applicable laws, statutes, rules, regulations and guidelines, including, without limitation, all good manufacturing practices and all applicable standards or guidelines promulgated by the appropriate Regulatory Authority.

1.3.	“Business Day” means any day other than a Saturday, a Sunday or a day on which commercial banks located in New York, New York are authorized or required by law to remain closed.
 
 	1.4.	“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
 
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 	1.5.	“Calendar Year” means any twelve (12) month period commencing on January 1.
 
 	1.6.	“Clinical Trial” means a clinical study of Product as described in 21 CFR §312.21(a) (“Phase I Clinical Trial”), 21 CFR §312.21(b) (“Phase II Clinical Trial”), or 21 CFR §312.21(c) (“Phase III Clinical Trial”) (in each case as hereafter modified or amended and including any foreign equivalents thereto).
 
 	1.7.	“Closing” has the meaning provided in Section 2.7.1.
 
 	1.8.	“Closing Date” has the meaning provided in Section 2.7.1.

1.9.	“Combination Product” means a Product that includes a Compound and at least one (1) Other Active Ingredient.
 
 	1.10.	“Commence” when used with respect to a Clinical Trial, means [***].
 
 	1.11.	“Commercialize” or “Commercialization” means to manufacture for sale, market, promote, distribute, and sell.

1.12.	“Commercially Reasonable Efforts” means, with respect to the Development or Commercialization of a Product, that level of efforts and resources commonly dedicated in the research-based pharmaceutical industry by a company to the development or commercialization, as the case may be, of a product of similar commercial potential at a similar stage in its lifecycle, in each case taking into account issues of safety and efficacy, product profile, the proprietary position, the then current competitive environment for such product and the likely timing of such product’s entry into the market, the regulatory environment and status of such product, and other relevant scientific, technical and commercial factors.

1.13.	“Compound” means (a) the compound designated by PFIZER as PF-05208767, also known as “neratinib,” “WAY 179272” or “HKI-272” (the “Neratinib Compound”), (b) the compound designated by PFIZER as PF-05208766, also known as “WAY 178357” or “HKI-357” (the “HKI-357 Compound”), (c) [***], (d) [***], (e) [***], and (f) [***], as well as [***].
 
 	1.14.	“Control” or “Controlled” means, with respect to any Intellectual Property Rights, material or document, the legal authority or right (whether by ownership, license or otherwise) of a Party to grant a license or a sublicense of or under such Intellectual Property Rights, or to provide or provide access to such material or document, to the other Party without breaching the terms of any agreement with a Third Party.

1.15.	“Develop” or “Development” means to conduct any and all research and development activities (including related manufacturing activities) necessary to obtain Regulatory Approval.
 
2

 	1.16.	“DR Executives” has the meaning provided in Section 16.2.
 
 	1.17.	“Excess Trial Expenses” has the meaning provided in Section 3.6.4.
 
 	1.18.	“Existing Advanced Trials” means [***].
 
 	1.19.	“Existing Other Trials” means the trials set forth under the headings [***], excluding the Existing Advanced Trials.
 
 	1.20.	“Existing Product” means any Product that is the subject of an Existing Trial as of the Execution Date.

1.21.	“Existing Trials” means the Existing Advanced Trials and the Existing Other Trials.
 
 	1.22.	“FDA” means the United States Food and Drug Administration, or a successor federal agency thereto.
 
 	1.23.	“Financing Condition” means confirmation (1) that LICENSEE has issued and sold equity securities resulting in gross proceeds to LICENSEE of at least $25 million, and (2) that the net worth of the LICENSEE immediately following such financing shall be at least $22.5 million. To satisfy the Financing Condition, LICENSEE shall provide PFIZER with a Balance Sheet, certified by LICENSEE’s President or Chief Financial Officer, and such other evidence as PFIZER may reasonably request.

1.24.	“First Commercial Sale” means with respect to a Product, the first sale for use or consumption by an end user of the Product following receipt of Regulatory Approval for such Product in a country in the Territory.
 
 	1.25.	“Future Patent Rights” means all Patents other than Patent Rights that (a) are Controlled by PFIZER or its Affiliates during the term of the Agreement and (b) [***]. For the avoidance of doubt, to the extent included in the foregoing, “Future Patent Rights” shall:
1.25.1. include [***];

1.25.2. exclude [***]; and

1.25.3. include [***].

 	1.26.	“GAAP” means the generally accepted accounting principles in the United States, consistently applied.

1.27.	“GHC License Agreement” means the License Agreement between The General Hospital Corporation d/b/a Massachusetts General Hospital (“MGH”) and Wyeth, an Affiliate of PFIZER, acting through its Wyeth Pharmaceuticals Division dated as of December 21, 2006.
 
3

 	1.28.	“Governance Committee” has the meaning set forth in Section 4.6.
 
 	1.29.	“IND” means: (a) an investigational new drug application filed with the FDA for authorization for the investigation of a Product, and (b) any of its foreign equivalents as filed with the applicable Regulatory Authorities in other countries or regulatory jurisdictions in the Territory, as applicable.

1.30.	“Intellectual Property Rights” means all trade secrets, copyrights, patents and other patent rights, Trademarks, moral rights, know-how and any and all other intellectual property or proprietary rights now known or hereafter recognized in any jurisdiction.
 
 	1.31.	“Know-How” means all confidential and proprietary information and data Controlled by PFIZER (i) [***], and (ii) any other confidential and proprietary information and data Controlled by PFIZER [***].
 
 	1.32.	“Knowledge” means first hand and actual knowledge of [***] and is not meant to require or imply [***].
 
 	1.33.	“Licensed Technology” means collectively, the Patent Rights and Know-How.

1.34.	“Licensee Trial Cost Cap” means the [***] the [***] that LICENSEE may incur beginning on January 1, 2012 in conducting the Existing Trials under Section 3.6. The parties acknowledge and agree that any expenses that LICENSEE incurs as a result of [***] will not be counted towards the Licensee Trial Cost Cap. In addition, Section 4.4.2 sets forth certain [***], and Section 4.4.3 sets forth [***].
 
 	1.35.	“Major Market Country” means each of the United States, Canada, the United Kingdom, France, Germany, Italy, Spain, the Nordic countries, China, and Japan.
 
 	1.36.	“Milestone” means each milestone as set forth in Section 5.1.1.

1.37.	“NDA/BLA” means: (a) a new drug application or a biologic license application filed with the FDA for authorization for marketing a Product, and (b) any of its foreign equivalents as filed with the applicable Regulatory Authorities in other countries or regulatory jurisdictions in the Territory, as applicable.

1.38.	“Net Sales” means the gross amount invoiced by or on behalf of LICENSEE, its Affiliates and their respective sublicensees for sales of any Product in the Territory (other than sales among LICENSEE, its Affiliates or sublicensees for subsequent resale in which case the first sale to a Third Party that is not a sublicensee shall be used for calculation of Net Sales), less the following deductions if and to the extent they are (i) included in the gross invoiced sales price of the Product or otherwise directly incurred by LICENSEE, its Affiliates and their respective sublicensees with respect to the sale of the Product, (ii) normal and customary, and (iii) not otherwise deducted in computing other amounts hereunder: (a) rebates, quantity and cash discounts, and other discounts

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 	to customers, (b) taxes (except income taxes) and tariffs or duties paid, absorbed or allowed which are directly related to the sale of the Product, (c) credits, allowances, discounts and rebates to, and chargebacks for, spoiled, damaged, out-dated, rejected or returned Product (including in connection with Product withdrawals, expired Product and Product recalls), (d) actual freight and insurance costs, including without limitation the costs of export licenses, shipping, postage and handling charges, incurred in transporting the Product to customers, (e) discounts or rebates or other payments required by Applicable Law, including any governmental special medical assistance programs, (f) customs duties, surcharges and other governmental charges incurred in connection with the exportation or importation of the Product, and (g) bad debts actually written off in connection with such Products.

Subsections (a) through (g) shall be collectively referred to as “Deductions”. The following principles shall apply in the calculation of Net Sales:

 	    	1.38.1. In the case of any sale of Product which is not invoiced or is delivered before invoice, Net Sales shall be calculated at the time of shipment or when the Product is paid for, if paid for before shipment or invoice.
 
 	    	1.38.2. In the case of any sale or other disposal of Product for non-cash consideration, Net Sales shall be calculated as the fair market price of the Product in the country of sale or disposal. Notwithstanding the foregoing, provision of the Product for the purpose of conducting pre-clinical or clinical research shall not be deemed to be a sale. For clarity, any Product provided as free samples or as charitable donations shall not give rise to any Net Sales.

1.38.3. Net Sales shall be determined in accordance with GAAP.
Notwithstanding the foregoing, in the event a Product is sold in a country in the Territory as a Combination Product, Net Sales of the Combination Product will be calculated as follows:

 	  	(i) If the Compound contained in the Combination Product and Other Active Ingredient(s) contained in the Combination Product each are sold separately in such country, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is the average gross selling price in such country of the Compound sold separately in the same formulation and dosage, and B is the sum of the average gross selling prices in such country of such Other Active Ingredient(s) sold separately in the same formulation and dosage, during the applicable Calendar Year.

(ii) If the Compound contained in the Combination Product is sold independently of the Other Active Ingredient(s) contained in the Combination Product in such country, but the average gross selling price of such Other Active Ingredient(s) in such country cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination
 
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 	Product by the fraction A/C where A is the average gross selling price in such country of such Compound sold independently and C is the average gross selling price in such country of the entire Combination Product, during the applicable Calendar Year.

(iii) If the Other Active Ingredient(s) contained in the Combination Product are sold independently of the Compound contained in the Combination Product in such country, but the average gross selling price of such Compound in such country cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction (1-(B/C)), where B is the average gross selling price in such country of such Other Active Ingredient(s) and C is the average gross selling price in such country of the entire Combination Product, during the applicable Calendar Year.

(iv) If the Compound contained in the Combination Product and Other Active Ingredient(s) contained in the Combination Product are not sold separately in such country, or if they are sold separately but the average gross selling price of neither such Compound nor such Other Active Ingredient(s) can be determined in such country, Net Sales of the Combination Product in such country will be calculated by mutual agreement of the Parties.
 
 	1.39.	“Other Active Ingredient” means any therapeutically active pharmaceutical ingredient other than a Compound.

1.40.	“Patents” means (a) unexpired letters patent (including without limitation inventor’s certificates), including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, addition, renewal, supplemental protection certificate or inventor’s certificate, and (b) pending applications for letters patent, including without limitation any continuation, divisional, or continuation-in-part thereof, and any provisional or nonprovisional applications, and (c) all foreign or international equivalents of any of the foregoing in any country.

1.41.	“Patent Rights” means all Patents that (i) (a) are Controlled by PFIZER or its Affiliates as of the Execution Date or the Closing Date and (b) [***] or (ii) (A) are Controlled by PFIZER or its Affiliates during the term of this Agreement, (B) [***] and (C) [***]. The Patent Rights existing as of the Execution Date are set forth on Schedule A, which shall be updated from time to time, at least annually, to identify any new Patents or any changes in the status of Patents. “Patent Rights” shall also include any [***]. For the avoidance of doubt, to the extent included in the foregoing, “Patent Rights” shall:
1.41.1. include [***];

1.41.2. exclude [***]; and

1.41.3. include [***].

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 	1.42.	“Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.
 
 	1.43.	“[***]” has the meaning set forth in Section 3.5.
 
 	1.44.	“PFIZER Retained Rights” means PFIZER’s rights under Sections 2.3 and 2.4 of this Agreement.
 
 	1.45.	“Product” means a Compound or any product that contains a Compound.

1.46.	“Regulatory Approval” means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization that is required by the applicable Regulatory Authority to market and sell the Product in such country or jurisdiction.
 
 	1.47.	“Regulatory Authority” means any governmental agency or authority responsible for granting Regulatory Approvals for a Product in the Territory.
 
 	1.48.	“Regulatory Filings” means, with respect to a Product, any submission to a Regulatory Authority of any appropriate regulatory application, including, without limitation, any IND, NDA/BLA, any submission to a regulatory advisory board, any marketing authorization application, and any supplement or amendment thereto.

1.49.	“Royalty Term” means, on a Product-by-Product and country-by-country basis, the period commencing on the First Commercial Sale of the Product in such country and expiring upon the later of: (a) expiration or abandonment of the last Valid Claim of the Patent Rights which covers Use of the Product in such country, or (b) the earlier of (x) the time when Generic Competitors to the Product have achieved [***], or (y) [***] following the date of First Commercial Sale of the Product in such country. “Generic Competitors” means, with respect to any Product being sold in any country, [***].
 
 	1.50.	“Territory” means worldwide.
 
 	1.51.	“Third Party” means any Person other than a Party or an Affiliate of a Party.
 
 	1.52.	“Trademarks” has the meaning as set forth in Section 13.6.5(d).
 
 	1.53.	“Transition Committee” has the meaning set forth in Section 3.2.1.

1.54.	“Transition Committee Identification Date” has the meaning set forth in Section 3.1.6.
 
 	1.55.	“Transition Plan” has the meaning set forth in Section 3.2.1.
 
 	1.56.	“Trial Completion Activities” has the meaning set forth in Section 3.6.
 
 	1.57.	“Trial Completion Plan” has the meaning set forth in Section 3.6.
 
 	1.58.	“Use” means to make, have made, Develop, Commercialize, use, sell, offer for sale, import, and export.
 
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1.59.	“Valid Claim” means either: (a) a claim of an issued and unexpired patent included within the Patent Rights, which has not been permanently revoked or declared unenforceable or invalid by an unreversed and unappealable or unreversed and unappealed decision of a court or other appropriate body of competent jurisdiction, or (b) a claim of a pending patent application included within the Patent Rights, which claim was filed in good faith, has not been pending for more than [***], and has not been abandoned or finally disallowed without the possibility of appeal or refiling of such application.
 
2.	LICENSE GRANT; CLOSING.
 
 	2.1.	License Grant.

2.1.1. Patent Rights. Subject to the terms and conditions of this Agreement, including the PFIZER Retained Rights, PFIZER hereby grants to LICENSEE as of the Closing Date an exclusive, sublicensable (subject to Section 2.2), royalty-bearing right and license under the Patent Rights to Use the Products within the Territory. For clarity, the license rights include an exclusive sub-license of rights under the GHC License Agreement, subject to Section 2.6.
 
 	    	2.1.2. Know How. Subject to the terms and conditions of this Agreement, including the PFIZER Retained Rights, PFIZER hereby grants to LICENSEE as of the Closing Date an exclusive, sublicensable (subject to Section 2.2), royalty-bearing right and license to use the Know-How in connection with the Use of Products within the Territory.
 
 	    	2.1.3. Future Patent Rights.
 
 	(a)	[***].

(b)	[***]. Pfizer may by written notice to LICENSEE at any time (but subject to LICENSEE’s consent thereto) elect to [***]. Additionally, as set forth in Section 8.7, LICENSEE has the right to request (which request is subject to PFIZER’s consent) [***] subject to the [***]. If a Party so proposes [***], and the other Party consents to such proposal, as provided in this Section 2.1.3 [***], then thereafter such [***].
 
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2.2.	Sublicense Rights. After the Closing Date, LICENSEE may sublicense the rights granted to it by PFIZER under this Agreement to any of its Affiliates or to any Third Party, provided that LICENSEE provides to PFIZER prompt written notice after it grants any such sublicense, and further provided that any Third Party sublicensee shall have the necessary financial and technical capacity to carry out the portion of LICENSEE’s obligations under this Agreement sublicensed to such Third Party. Any and all sublicenses shall be subject to the following requirements:
2.2.1. All sublicenses shall be subject to and consistent with the terms and conditions of this Agreement. In no event shall any sublicense relieve LICENSEE of any of its obligations under this Agreement.

2.2.2. LICENSEE shall furnish to PFIZER a true and complete copy of each sublicense agreement and each amendment thereto, which sublicense agreement may be redacted to omit information not directly relevant to the performance of LICENSEE’s obligations under this Agreement, within thirty (30) days after the sublicense or amendment has been executed.

2.2.3. Any sublicense of the rights granted to LICENSEE under Section 2.1.3(a) shall be granted only in connection with a sublicense of the rights granted to LICENSEE under Section 2.1.1.

 	2.3.	Retained Rights. LICENSEE acknowledges and agrees that PFIZER retains the right for itself and its Affiliates to make, have made, use, have used, import and export Products [***].

2.4.	Residuals. PFIZER may use for any purpose (other than the development, manufacture or Commercialization of Compounds or Products during the term of this Agreement) the Residuals resulting from PFIZER’s access to or work with Products and Know-How. As used herein, “Residuals” means information in non-tangible form which may be retained by persons who have had access to Products or Know-How, including information relating to ideas, concepts, know-how or techniques.
 
 	2.5.	No Additional Rights. Nothing in this Agreement shall be construed to confer any rights upon LICENSEE by implication, estoppel, or otherwise as to any technology or Intellectual Property Rights of PFIZER or its Affiliates other than the Licensed Technology, regardless of whether such technology or Intellectual Property Rights shall be dominant or subordinate to any Licensed Technology.

 	2.6.	The GHC License Agreement. LICENSEE acknowledges that its rights herein under Patent Rights that are subject to the GHC License Agreement are, in addition to being limited by the terms and conditions of this Agreement, further limited by the terms and conditions of the GHC License Agreement. To the extent requested by PFIZER from time-to-time, LICENSEE will assume Wyeth’s (or PFIZER’s) obligations under the GHC License Agreement and/or take reasonable steps to support Wyeth’s (or PFIZER’s) compliance with obligations therein. At any time, LICENSEE may, upon [***] advanced written notice to PFIZER, elect to terminate its license (and sublicense) under the Patent Rights that are subject to the GHC License Agreement. Upon and after the effective date of such termination, LICENSEE shall have no further obligations under this Section 2.6, and no further rights or obligations under this Agreement, with

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respect to such Patent Rights, which shall no longer be considered “Patent Rights” herein. Additionally, no breach by LICENSEE of its obligations under the second sentence of this Section 2.6 (the “GHC Obligations”) shall be a material breach of this Agreement by LICENSEE permitting termination of the entire Agreement by PFIZER. Instead, PFIZER’s right to terminate for any material breach by LICENSEE of the GHC Obligations shall be limited to terminating LICENSEE’s license and sublicense under the Patent Rights that are subject to the GHC License Agreement.

 	2.7.	Closing.

2.7.1. Generally. The licenses granted pursuant to Section 2.1 shall become effective (the “Closing”) as of the date (the “Closing Date”) on which the satisfaction or waiver of each of the conditions set forth in Sections 2.7.2 and 2.7.3 has occurred. If the Closing does not occur within [***] days of the Execution Date, this Agreement shall terminate effective as of the end of such period.

2.7.2. Pfizer Closing Condition. The obligations of PFIZER to consummate the transactions contemplated by this Agreement, including the licenses granted pursuant to Section 2.1, are conditioned upon satisfaction of the Financing Condition and PFIZER’s receipt of written notice thereof from LICENSEE; provided that PFIZER may waive such condition. Following such satisfaction and receipt of written notice (or PFIZER’s waiver of such condition), PFIZER will provide to LICENSEE written confirmation (the “Pfizer Confirmation”) that the representations and warranties of PFIZER contained in Sections 10.1 and 10.2 are true and correct in all material respects as of the date of such confirmation as if made on the date of such confirmation; provided that such written confirmation may include exceptions (“Exceptions”) to such representations and warranties if applicable (which Exceptions, for clarity, if deemed accepted by LICENSEE pursuant to Section 2.7.3, will then apply to such representations and warranties of PFIZER herein made both as of the Execution Date and the Closing Date).

2.7.3. Licensee Closing Condition. The obligations of LICENSEE to consummate the transactions contemplated by this Agreement, including the licenses granted pursuant to Section 2.1, are conditioned upon PFIZER providing the Pfizer Confirmation (as defined in Section 2.7.2) without Exceptions to LICENSEE; provided that if PFIZER provides the Pfizer Confirmation with Exceptions to LICENSEE, LICENSEE may waive such condition by written notice to PFIZER. If LICENSEE so waives the above condition, LICENSEE shall be deemed to have accepted the Exceptions, and PFIZER’s representations and warranties under Sections 10.1 and 10.2 shall be deemed modified by the Exceptions both as of the Execution Date and as of the Closing Date.

2.7.4. Financing Condition. LICENSEE will use commercially reasonable efforts to satisfy the Financing Condition in as short a time as practicable, and

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will provide PFIZER prompt written notice thereof. LICENSEE will provide PFIZER with weekly updates regarding its progress towards satisfying the Financing Condition.

3.	TRANSITION, [***], AND EXISTING TRIALS
 
 	3.1.	Overview. This Section provides for the transition of legal, operational and financial responsibility for Existing Trials and certain related Product development efforts from PFIZER to LICENSEE. The Parties shall use commercially reasonable efforts to complete such transition as expeditiously as practicable.

3.1.1. During the period from the Execution Date until the Closing Date, PFIZER shall have sole responsibility for conducting all Product Development, including the Existing Trials, as PFIZER may determine, in PFIZER’s sole discretion, and [***].

3.1.2. As of the Closing Date, LICENSEE shall have sole responsibility for Product Development and Commercialization, subject to the terms and conditions of this Agreement, including the transition provisions of this Section 3 and the provisions of Section 4, at LICENSEE’s sole expense, except as otherwise expressly provided in this Agreement.

3.1.3. During the period from the Closing Date through December 31, 2011 (the “Transition Period”), as more fully provided below, [***], subject to the direction and control of the Transition Committee (once formed, as provided for below), [***].

3.1.4. During the Transition Period, PFIZER will provide necessary documentation and other materials to LICENSEE and PFIZER and LICENSEE will satisfy their respective obligations under an agreed Transition Plan, as more fully provided below.

3.1.5. During the period from January 1, 2012 through [***] in accordance with Section 3.5 below.

3.1.6. As soon as reasonably practicable, but no later than [***], the Parties will identify in writing to each other their initial members of the Transition Committee (it being understood that it is important to have the Transition Committee available as soon as reasonably practicable). As used herein, the “Transition Committee Identification Date” means the earlier of [***].

 	3.2.	Transition Committee.

3.2.1. The Parties will establish, as of the Transition Committee Identification Date, a joint committee to provide advice and input, and make decisions, with respect to (a) the implementation of the Transition Plan set forth in Schedule B

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(the “Transition Plan”), (b) the Parties’ Trial Completion Activities and Trial Completion Plan set forth in Schedule C and (c) [***], if any, and to review the progress of such activities (the “Transition Committee”). The Transition Committee will have an equal number of representatives from each Party and decisions of the Transition Committee shall be made unanimously by the representatives. In the event that the Transition Committee cannot or does not, after good faith efforts, reach agreement on any issue within [***] after first considering such issue, such issue shall be referred directly to dispute resolution by the DR Executives as set forth in the second and third sentences of Section 16.2, and Sections 16.4 and 16.5.

3.2.2. Unless otherwise agreed upon in writing by the Parties, the Transition Committee shall meet, in person or by telephone, not less than [***] after the Transition Committee Identification Date and not less than [***] thereafter until [***]. In such meetings, the Transition Committee shall (i) review the progress being made under the Transition Plan and Trial Completion Plan, and the [***], (ii) discuss future activities to be conducted under the Transition Plan and Trial Completion Plan, and the [***], and the extent to which additional resources need to be applied by either Party or both to complete the transition and achieve trial completion, (iii) review and monitor the budget for Trial Completion Activities for Existing Trials, and (iv) review and agree upon any necessary or desired revisions to the Transition Plan or Trial Completion Plan, or the [***]. Upon the request of a Party’s representative on the Transition Committee, subject to the other Party’s prior consent (not to be unreasonably withheld or delayed), other personnel from such Party may attend and participate in such meetings. It is the objective of the Parties, working through the Transition Committee, and in accordance with the terms and conditions of this Agreement including the Schedules hereto, to insure (A) as smooth and efficient a transition from PFIZER to LICENSEE as reasonably practical of all relevant documentation, materials, contractual obligations and regulatory responsibilities related to Products and the Existing Trials and (B) as smooth and efficient a completion of the Existing Trials as reasonably practicable, in both cases in accordance with accepted pharmaceutical industry norms, ethical practices and Applicable Law.

3.2.3. PFIZER’s participation in the Transition Committee is a right and not an obligation; provided that in the event that PFIZER elects not to participate in such committee, LICENSEE shall have the right to proceed with decision-making with respect to such committee at its sole discretion.

 	3.3.	Transfer of Documentation. PFIZER will make available and transfer to LICENSEE, at no cost to LICENSEE, originals or copies of currently available records, data and documentation described in Schedule B as being provided by PFIZER to LICENSEE, as set forth in Section 1.1.1 of Schedule B which exist and are Controlled by PFIZER or its Affiliates as of the Execution Date and are necessary for LICENSEE to continue Developing Products (collectively, “Documentation”); provided that LICENSEE agrees that any failure by PFIZER to provide [***] to LICENSEE shall [***].

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 	3.4.	Transition Plan. During the Transition Period, PFIZER and LICENSEE shall each use commercially reasonable efforts to perform the transition activities specified for each Party in the Transition Plan.
 
 	3.5.	[***]. After December 31, 2011, [***]. PFIZER will [***] and LICENSEE shall [***].

3.6.	Trial Completion Activities With Respect to Existing Trials. Starting on the Closing Date, each Party will conduct the Existing Trials to the extent it is obligated to do so in this Section 3.6, in accordance with the Trial Completion Plan attached as Schedule C (the “Trial Completion Plan” and such activities, the “Trial Completion Activities”). The Parties’ Trial Completion Activities will be subject to the Transition Committee’s oversight and any modification of a Party’s obligations with respect to Trial Completion Activities will [***].
3.6.1. During the Transition Period, PFIZER will continue to conduct or have conducted the Existing Trials on behalf of LICENSEE, subject to the direction and control of the Transition Committee, [***].

3.6.2. PFIZER and LICENSEE will use commercially reasonable efforts to effect the assignment or other transfer by PFIZER or its Affiliate to LICENSEE, [***], of all existing INDs filed by PFIZER or its Affiliates for Compounds prior to the end of the Transition Period, as more fully provided in the Transition Plan.

3.6.3. No later than [***], LICENSEE shall assume direct operational management and sole financial responsibility (subject to the Licensee Trial Cost Cap provisions as provided below) for all Existing Trials.

3.6.4. Solely with respect to LICENSEE’s conduct of Trial Completion Activities with respect to Existing Trials on and after [***], PFIZER will reimburse LICENSEE for Excess Trial Expenses, if any. “Excess Trial Expenses” means those [***] in excess of the Licensee Trial Cost Cap to conduct such Trial Completion Activities, excluding any expenses that are [***]. LICENSEE will deliver to PFIZER a written report within [***] after the end of each Calendar Quarter setting forth in reasonable detail [***]. PFIZER will reimburse LICENSEE for applicable Excess Trial Expenses within [***] after its receipt of such report stating such expenses, with such back-up information documenting such expenses as PFIZER may reasonably request, and an invoice for the relevant amount.

3.6.5. Notwithstanding anything herein to the contrary, PFIZER shall not be obligated to [***] in conducting any Trial Completion Activities or in connection with the Trial Completion Plan, or in regard to any other Development or Commercialization activities, except as expressly set forth in this Section 3.

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4.        DEVELOPMENT, COMMERCIALIZATION, REGULATORY, MANUFACTURING, COMPARATOR DRUGS, TRIAL COMPLETION, GOVERNANCE COMMITTEE AND REPORTS.

 	4.1.	Development.

4.1.1. General Diligence. LICENSEE shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts to Develop Products in each Major Market Country and each other country in which LICENSEE determines that Development of Products would fall within Commercially Reasonable Efforts to Develop Products. Such Development activities shall include without limitation, and without limiting the generality of the foregoing, those set forth in the Development plan attached to this Agreement as Schedule D (as the same may be modified from time to time by LICENSEE, as delivered in writing to PFIZER, the “Development Plan”). The Parties acknowledge that under appropriate circumstances it may fall within Commercially Reasonable Efforts in Developing Products for LICENSEE to decide not to advance to the next stage of Development depending on the outcomes of prior stages of Development. Subject to Section 4.1.2 below, the Parties further acknowledge that under appropriate circumstances it may fall within Commercially Reasonable Efforts in Developing Products for LICENSEE to decide to terminate or wind down a clinical trial.

4.1.2. Existing Trials. The Parties acknowledge and agree on the importance of conducting the Existing Trials in accordance with the Transition Plan and Trial Completion Plan. Notwithstanding any other provision of this Agreement, no Existing Advanced Trial will be terminated or wound down (other than as set forth in the relevant Trial Completion Plan) other than in the following circumstances:

 	(a)	if at any time LICENSEE becomes aware of safety concerns with respect to the relevant Product in a given indication, LICENSEE may terminate or wind down the Existing Advanced Trial in the same indication (or if in the reasonable judgment of LICENSEE, such safety concerns affect the Product regardless of indication, both Existing Advanced Trials) without any need for PFIZER’s consent thereto, provided that LICENSEE shall discuss such concerns with PFIZER;

(b)	if, on a trial-by-trial basis, after the date which is [***], any of the following events occurs, LICENSEE may terminate or wind down such Existing Advanced Trial without any need for PFIZER’s consent thereto, provided that LICENSEE shall discuss such events with PFIZER: (i) the occurrence of material changes in the market for, or the commercial potential of, the relevant Product, (ii) material adverse changes in the
 
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intellectual property protection available for the relevant Product (other than by reason of any actions taken by LICENSEE), or (iii) LICENSEE becomes aware of any material change in data that indicates that the relevant Product will not be efficacious for the indication being studied in such Existing Advanced Trial; or
 
 	(c)	except as set forth in clause (a) or (b) above, only with PFIZER’s prior written consent (not to be unreasonably withheld).

4.1.3. New Clinical Trial. Without limiting the generality of the foregoing, LICENSEE shall itself, or through its Affiliates or sublicensees, (a) Commence a new Clinical Trial for a Product no later than [***] (subject to extension for a period mutually agreed upon by the Parties in the event that LICENSEE is unable to Commence such Clinical Trial by such date because of events or circumstances beyond its reasonable control), (b) use Commercially Reasonable Efforts to complete such Clinical Trial in accordance with the Development Plan, and (c) use Commercially Reasonable Efforts to achieve the clinical and regulatory milestones set forth in the Development Plan.

4.1.4. LICENSEE will undertake the activities described in this Section 4.1 at its sole expense, subject to Section 3.6 with respect to the Existing Trials. Subject to its obligations under this Section 4.1 and Sections 3 and 4.3, LICENSEE shall have sole decision making authority with respect to such activities.

 	4.2.	Commercialization. LICENSEE shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts to Commercialize the Product in each Major Market Country after obtaining Regulatory Approval of Products in such country, and each other country in which LICENSEE determines that Commercialization of Products would fall within Commercially Reasonable Efforts to Commercialize Products, after obtaining Regulatory Approval of Products in such country. LICENSEE will undertake such activities at the sole expense of LICENSEE, its Affiliates or sublicensees, and subject to the foregoing diligence obligations, LICENSEE will have sole decision making authority with respect to such activities. The Parties acknowledge that under appropriate circumstances it may fall within Commercially Reasonable Efforts in Commercializing Products for LICENSEE to decide not to advance to the next stage of Commercialization depending on the outcomes of prior stages of Commercialization.

4.3.	Regulatory and Pharmacovigilance.
4.3.1. In connection with its efforts to Develop Products, as between the Parties, LICENSEE shall bear all responsibility (subject to Sections 3 and 4.3.2) and expense for filing Regulatory Filings in LICENSEE’s name and obtaining Regulatory Approval for Products.

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4.3.2. PFIZER shall use commercially reasonable efforts to transfer sponsorship of the Existing Trials (other than the IIRs) and all regulatory reporting requirements relating to the safety of the Product effective as of December 31, 2011. After sponsorship for all such trials has been transferred to LICENSEE pursuant to the Transition Plan, LICENSEE shall have all regulatory and pharmacovigilance responsibilities for the Compounds and Products as of such transfer date. During the period after the Closing Date and prior to such transfer date, the Parties shall keep each other informed as to the status of this transfer via the Transition Committee and shall discuss whether or not it may be necessary to put in place a written agreement for exchanging adverse event and other safety information relating to the Products prior to PFIZER’s or its Affiliate’s transfer of any existing IND to LICENSEE. If they agree that such an agreement is necessary, they shall promptly meet and agree upon such an agreement (the “Pharmacovigilance Agreement”). The Pharmacovigilance Agreement shall ensure that adverse events and other safety information is exchanged upon terms that will permit each Party to comply with Applicable Laws and requirements of Regulatory Authorities.

4.4.1. As of the Closing Date, LICENSEE will be responsible, at its own cost, for all aspects of manufacturing Products for its Use; provided that during the period from the Closing Date through December 31, 2011, if LICENSEE has been negotiating in good faith with Third Party contract manufacturers but has not yet entered into agreements for the manufacture of Products with such Third Parties, then at LICENSEE’s request, PFIZER will use reasonable efforts upon reasonable notice to order the quantities of Product requested by LICENSEE in writing, at LICENSEE’s cost; provided further that via the Transition Committee, the Parties will discuss necessary lead times and how to handle release testing and any other activities related to any such request. LICENSEE agrees that it shall comply with the applicable requirements of 35 U.S.C. § 204 to the extent required in connection with manufacturing Products; provided, however, that PFIZER will, upon LICENSEE’s request and at LICENSEE’s expense, request pursuant to the GHC License Agreement that MGH assist LICENSEE in obtaining a waiver of the foregoing requirement, in the event such a waiver should be required.

4.4.2. With respect to the Pfizer Neratinib Inventory and Comparator Inventory (as both defined in Section 6.2 of the Transition Plan) transferred to LICENSEE pursuant to the Transition Plan, to the extent that either (a) LICENSEE uses any such Pfizer Neratinib Inventory or Comparator Inventory [***] and LICENSEE subsequently [***] for use in conducting the Existing Trials under Section 3.6 or (b) LICENSEE [***] and instead LICENSEE [***], then [***].

4.4.3. To the extent any comparator drugs are required for the Trial Completion Activities beyond the Comparator Inventory transferred to LICENSEE pursuant to the Transition Plan, LICENSEE shall be responsible for acquiring such

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additional comparator drugs at its own expense; provided that during the period from the Closing Date through December 31, 2011, if LICENSEE has been negotiating in good faith with Third Party suppliers of comparator drugs but has not yet entered into agreements for the supply of comparator drugs with such Third Parties, then at LICENSEE’s request, PFIZER will use reasonable efforts upon reasonable notice to order the quantities of comparator drugs for use in the Existing Advanced Trials requested by LICENSEE in writing, at LICENSEE’s expense [***]; provided further that via the Transition Committee, the Parties will discuss necessary lead times and any other activities related to any such request.

 	4.5.	Trial Completion. With respect to the Existing Trials, each Party will perform the Trial Completion Activities in accordance with Section 3.6.

4.6.1. The Parties will establish a joint governance committee to provide advice and input with respect to Development and Commercialization plans and activities relating to Products and to review the progress of such activities (the “Governance Committee”). The Governance Committee will have an equal number of representatives from each Party, provided that LICENSEE will have final decision making authority with respect to matters before the committee (subject to LICENSEE’ s commitments and obligations under the Agreement). The Governance Committee will meet at least once per year or more frequently as agreed-upon by the Parties. Upon the request of a Party’s representative on the Governance Committee, subject to the other Party’s prior consent (not to be unreasonably withheld or delayed), other personnel from such Party may attend and participate in such meetings. PFIZER’s participation in the Governance Committee is a right and not an obligation; provided that in the event that PFIZER elects not to participate in such committee, LICENSEE shall have the right to proceed with decision-making with respect to such committee at its sole discretion.

4.6.2. LICENSEE shall provide PFIZER a written report in reasonable detail regarding LICENSEE’s progress in Development and Commercialization of each Product, including a summary of activities conducted, significant events or milestones achieved, and data obtained since the last report, and other activities under this Section 4. With respect to each Product, LICENSEE will deliver such report (a) within [***] after each June 30 and December 31 prior to the [***] for such Product, and (b) within [***] after the end of each Calendar Quarter thereafter.

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5.	PAYMENT TERMS
 
 	5.1.	Payment Terms.

5.1.1. Milestone Payments. LICENSEE shall notify PFIZER as soon as practicable upon achievement of each Milestone. In partial consideration of the licenses and rights granted to LICENSEE, within [***] after achievement of each Milestone set forth below, LICENSEE shall pay to PFIZER the corresponding non-creditable and non-refundable milestone payment (each, a “Milestone Payment”).
 
MILESTONE

  	MILESTONE
PAYMENT
(1) [***]

  	[***]
(2) [***]

  	[***]
(3) [***]

  	[***]
(4) [***]

  	[***]
(5) [***]

  	[***]
(6) [***]

  	[***]

(a)	For the avoidance of doubt: (i) each Milestone Payment shall be payable only once upon achievement of the applicable Milestone; and (ii) satisfaction of a Milestone by an Affiliate of LICENSEE or a sublicensee or assignee of, or Third Party retained by, LICENSEE or its Affiliates shall be deemed to have been satisfied by LICENSEE for purposes of this Section 5.1.1.
 
 	    	5.1.2. Royalty Payments.
 
 	(a)	In further consideration of the licenses and rights granted to LICENSEE hereunder, LICENSEE shall pay to PFIZER the royalties set forth below on Net Sales of Products in the Territory in each Calendar Year during the applicable Royalty Terms (collectively, “Royalties”).
 
NET SALES

  	INCREMENTAL ROYALTY RATE
The portion of aggregate worldwide Net Sales of all Products that is less than [***] per Calendar Year

  	[***] of Net Sales

The portion of aggregate worldwide Net Sales of all Products that is equal to or greater than [***] per Calendar Year

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 	(b)	LICENSEE shall pay to PFIZER the applicable Royalties within [***] following the end of each Calendar Quarter after the date of the First Commercial Sale of a Product.

(c)	In the event that LICENSEE [***] (the “Third Party Patents”), and if LICENSEE pays [***] under license agreements with such Third Parties [***] (the “Third Party Payments”), then LICENSEE may credit [***] of such Third Party Payments against the Royalties owed and payable on the Net Sales for such Product, as determined on a country-by-country basis. Notwithstanding the foregoing, in no event shall such credits reduce the Royalties payable to PFIZER [***] and [***].
 
 	(d)	All payments shall be accompanied by a report that includes reasonably detailed information regarding a total monthly sales calculation, on a country-by-country basis, of Net Sales of each Product (including gross sales and all Deductions) and all Royalties payable to PFIZER for the applicable Calendar Quarter (including any foreign exchange rates employed and conversion calculations).

5.1.3. Assumption of Responsibility. The Parties acknowledge that LICENSEE’s assumption of all responsibility, at its sole cost (except as set forth in Section 3), for the Existing Trials with effect from the Closing Date in accordance with Section 3, including LICENSEE’s Trial Completion Activities, shall serve as further consideration for the licenses and rights being granted to LICENSEE hereunder.

5.1.4. Other Payments. Except as otherwise expressly set forth herein, LICENSEE shall pay to PFIZER any other amounts due under this Agreement within [***] following receipt of invoice.

5.1.5. Late Payments. Any late payments shall bear interest, to the extent permitted by law, [***] above the Prime Rate of interest as reported in the Wall Street Journal on the date payment is due.

 	5.2.	Payment Method.

5.2.1. With respect to Net Sales invoiced in U.S. dollars, the Net Sales and the amounts due for Royalties hereunder will be expressed in U.S. dollars. With respect to Net Sales invoiced in a currency other than U.S. dollars, such Net Sales will be converted to U.S. 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, and the amounts due for Royalties hereunder will be expressed in U.S. dollars. For purposes of calculating the Net Sales thresholds set forth in [***], the aggregate Net Sales with respect to each Calendar Quarter within a Calendar Year will be calculated based on the currency exchange rates for the Calendar Quarter in which such Net Sales occurred, in a manner consistent with the exchange rate procedures set forth in the immediately preceding sentence.

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5.2.2. All payments from LICENSEE to PFIZER shall be made by wire transfer in US Dollars to the credit of such bank account as may be designated by PFIZER in writing to LICENSEE. Any payment which falls due on a date which is not a Business Day may be made on the next succeeding Business Day.

 	5.3.	Taxes.
5.3.1. VAT. It is understood and agreed between the Parties that any amounts payable by LICENSEE to PFIZER hereunder are [***] applicable sales, use, VAT, GST, excise, property, and other taxes, levies, duties or fees (collectively, “Taxes”), [***].

5.3.2. Withholding Taxes. If LICENSEE is required to make a payment to PFIZER subject to a deduction of tax or withholding tax, the sum payable by LICENSEE (in respect of which such deduction or withholding is required to be made) shall be made to PFIZER after deduction of the amount required to be so deducted or withheld, which deducted or withheld amount shall be remitted in accordance with applicable law, provided, however, that if such withholding or deduction obligation arises solely as a result of [***], then the sum payable by LICENSEE (in respect of which such deduction or withholding is required to be made) shall be [***]. Any amounts deducted, withheld and remitted in accordance with the provisions of this Section 5.3.2 shall be treated as having been paid by the LICENSEE to PFIZER for all purposes of this Agreement.

5.3.3. Tax Cooperation. To the extent LICENSEE is required to deduct and withhold taxes on any payments to PFIZER, LICENSEE shall pay the amounts of such taxes to the proper governmental authority in a timely manner and, upon PFIZER’s request, shall promptly transmit to PFIZER an official tax certificate or other evidence of such withholding sufficient to enable PFIZER to claim such payments of taxes. PFIZER shall provide to LICENSEE any tax forms that may be reasonably necessary in order for LICENSEE not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each party shall provide the other with reasonable assistance to enable the recovery, as permitted by law, of withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the party bearing such withholding tax or VAT.

5.3.4. Tax Forms. The Parties agree to cooperate and produce on a timely basis any tax forms or reports, including an IRS Form W-8BEN, reasonably requested by the other Party in connection with any payment made by LICENSEE to PFIZER under this Agreement.

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6.	RECORDS; AUDIT RIGHTS
 
 	6.1.	Relevant Records.

6.1.1. Relevant Records. LICENSEE shall keep, and shall cause its Affiliates and sublicensee to keep accurate financial books and records pertaining to: LICENSEE’s and its Affiliates’ and sublicensees’ sale of Products, including any and all calculations of payments due to PFIZER hereunder; LICENSEE’s prosecution, maintenance and enforcement of Patent Rights; and LICENSEE’s Trial Completion Activities (collectively, “Relevant Records”). LICENSEE, its Affiliates and sublicensees shall maintain the Relevant Records for the longer of: (a) the period of time required by Applicable Law, or (b) three (3) years following expiration or termination of this Agreement. LICENSEE shall require its sublicensees to provide to LICENSEE copies of all Relevant Records relating to such sublicensees’ sale of Products as necessary to allow PFIZER to review such Relevant Records when conducting an audit of LICENSEE pursuant to Section 6.1.2.

6.1.2. Audit Request. PFIZER shall have the right during the term and for three (3) years thereafter to engage, at its own expense, an independent auditor reasonably acceptable to LICENSEE to examine the Relevant Records in LICENSEE’s or its Affiliates’ possession from time-to-time, but no more frequently than once every twelve (12) months, as may be necessary to verify compliance with the terms of this Agreement. Such audit shall be requested in writing at least fifteen (15) Business Days in advance, and shall be conducted during LICENSEE’s (or its Affiliate’s, as applicable) normal business hours and otherwise in manner that minimizes any interference to LICENSEE’s (or its Affiliate’s, as applicable) business operations.

6.1.3. Audit Fees and Expenses. PFIZER shall bear any and all fees and expenses it may incur in connection with any such audit of the Relevant Records; provided, however, in the event an audit reveals an underpayment by LICENSEE of more than [***] as to the period subject to the audit, LICENSEE shall reimburse PFIZER for any reasonable and documented out-of-pocket costs and expenses of the audit within [***] after receiving invoices thereof.

6.1.4. Payment of Deficiency. If any audit establishes that LICENSEE underpaid any amounts due to PFIZER under this Agreement, then LICENSEE shall pay PFIZER any such deficiency within [***] after receipt of written notice thereof. For the avoidance of doubt, such payment will be considered a late payment, subject to Section 5.1.5. If any audit establishes that LICENSEE overpaid any amounts due to PFIZER under this Agreement, then LICENSEE shall be entitled to take a credit against future amounts becoming due to PFIZER equal to the overpaid amount.

7.	INTELLECTUAL PROPERTY RIGHTS

7.1.	Pre-existing IP. Subject only to the rights expressly granted to the other Party under this Agreement, each Party shall retain all rights, title and interests in and to any Intellectual Property Rights that are owned by, or licensed or sublicensed to, such Party prior to or independent of this Agreement.
 
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 	7.2.	Ownership of Inventions and Intellectual Property Rights.
7.2.1. “Inventions” means any and all inventions (whether or not patentable), that are conceived during the term of and in the course of activities conducted pursuant to this Agreement by one or more employees, Affiliates, sublicensees or independent contractors of PFIZER and/or LICENSEE.

7.2.2. Inventorship of Inventions shall be determined in accordance with the rules and regulations of the U.S. Patent and Trademark Office. All Inventions made solely by employees, agents and independent contractors of PFIZER or its Affiliates and all Intellectual Property Rights therein, shall be owned solely by PFIZER (“Pfizer Inventions”). All Inventions made solely by employees, agents and independent contractors of LICENSEE or its Affiliates or sublicensees, and all Intellectual Property Rights therein, shall be owned, as between the Parties, solely by LICENSEE (“Licensee Inventions”). All Inventions made jointly by employees, agents and independent contractors of each Party or its Affiliates or sublicensees (as applicable), and all Intellectual Property Rights therein, shall be owned jointly by the Parties such that each Party shall have an undivided interest therein (“Joint Inventions”). All Patents claiming patentable, jointly owned Joint Inventions shall be referred to herein as “Joint Patent Rights.” Except to the extent either Party is restricted by the licenses granted to the other Party and covenants set forth herein, each Party shall be entitled to practice and exploit the Joint Inventions without any duty of accounting or obligation to seek consent from the other Party with respect thereto.

7.3.	Further Actions; Developed IP. Each Party shall, and shall cause its sublicensees and Affiliates, and all independent contractors, employees and agents of such Party, to cooperate with the other Party and take all reasonable actions and execute such agreements, declarations, assignments, legal instruments and documents as may be reasonably required to perfect the other Party’s right, title and interest in and to Inventions, and Patents thereon, and other Intellectual Property Rights as set forth in Section 7.2.2. Each Party shall also include provisions in its relevant agreements with Third Parties that affect the intent of this Section 7.3. Licensee Inventions and LICENSEE’s interest in Joint Inventions, and all Intellectual Property Rights therein, that are related to any Compound or Product shall be “Developed IP.”
 
 	7.4.	Patent Prosecution and Maintenance.

7.4.1. LICENSEE shall be responsible for filing, prosecuting (including in connection with any reexaminations, oppositions and the like) and maintaining the Patent Rights in the Territory. LICENSEE shall file, prosecute and maintain the Patent Rights using qualified outside patent counsel and foreign patent

22

associates selected by LICENSEE; provided that LICENSEE identifies such counsel for PFIZER in advance and PFIZER consents to such counsel (such consent not to be unreasonably withheld or delayed). LICENSEE shall be responsible for all costs and expenses in connection with such filing, prosecution and maintenance; provided that if LICENSEE intends to abandon, or not file a patent application included in, any of the Patent Rights in any given country for any purposes, LICENSEE shall provide PFIZER with a written notice of such intent at least [***] in advance of the relevant deadline. In such case: (a) PFIZER will provide a written response to LICENSEE at least [***] in advance of the relevant deadline if PFIZER wishes, or wishes to allow a Third Party to, file, prosecute and maintain (in its sole discretion) such Patent Right in such country; (b) if PFIZER provides the affirmative notice under clause (a) above, the LICENSEE shall promptly provide all files related to filing, prosecuting and maintaining such Patent Right to counsel designated by PFIZER; (c) upon completion of the transfer of such files under clause (b), LICENSEE shall no longer be responsible for the costs and expenses relating to filing, prosecuting and maintaining (as applicable) such Patent Right in such country; and (d) the terms “Patent Rights” and “Future Patent Rights,” as applicable, automatically shall be [***].

7.4.2. LICENSEE shall provide PFIZER with material correspondence with each of the patent offices pertaining to LICENSEE’s prosecution of the Patent Rights. Upon the written request of PFIZER, LICENSEE shall provide PFIZER with draft copies of all filings and relevant documentation (to the extent not previously submitted to and reviewed by PFIZER) relating to a Patent Rights at least [***] prior to the required submission date and shall not file or submit any such filing or documentation until LICENSEE has received comments on such filing and documentation from PFIZER and considered any proposed comments to such filings and documentation in good faith, provided that LICENSEE may file or submit such filings or documentation without considering PFIZER’S comments if LICENSEE has not received any comments from PFIZER at least [***] prior to the required submission date. LICENSEE is not required to [***].

7.4.3. LICENSEE shall have the first right, but not the obligation, to prepare, file, prosecute and maintain any Joint Patent Right that is not a Patent Right, in each case throughout the world, using patent counsel that is reasonably acceptable to PFIZER. If LICENSEE declines to exercise its first right, PFIZER shall have the right (but not the obligation) to prepare, file, prosecute and maintain such Joint Patent Right, in each case throughout the world. The Party that at the time exercises the right to prepare, file, prosecute and maintain such a Joint Patent Right may be referenced as the “Controlling Party” below with respect thereto, and the other Party may be referenced as the “Other Party” below with respect thereto. The Controlling Party shall give the Other Party an opportunity to review the text of any patent application with respect to such Joint Patent Right at least [***] before filing and shall consider the Other Party’s

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comments in good faith. The Controlling Party shall supply the Other Party with a copy of the patent application as filed, together with notice of its filing date and serial number. To the extent it is Controlling Party for such Joint Patent Rights, LICENSEE shall follow the patent prosecution practice described in Sections 7.4.1 and 7.4.2. The Other Party shall reimburse the Controlling Party for fifty percent (50%) of the costs incurred by the Controlling Party in preparing, filing, prosecuting and maintaining any such Joint Patent Right, which reimbursement will be made pursuant to invoices submitted by the Controlling Party to the Other Party no more often than once per Calendar Quarter; provided that, for clarity, LICENSEE shall be responsible for all such costs for any Joint Patent Right that is also a Patent Right. If either Party (the “Declining Party”) at any time declines to share in the costs of filing, prosecuting and maintaining any such Joint Patent Right, on a country by country basis, the Declining Party shall provide the other Party (the “Continuing Party”) with [***] prior written notice to such effect, in which event, (i) the Declining Party shall have no responsibility for any expenses incurred in connection with such Joint Patent Right after the end of such [***] period, (ii) if the Continuing Party elects to continue prosecution or maintenance, the Declining Party, upon the Continuing Party’s request, shall execute such documents and perform such acts, at the Continuing Party’s expense, as may be reasonably necessary to assign to the Continuing Party all of the Declining Party’s right, title and interest in and to such Joint Patent Right, with such Joint Patent Right automatically ceasing to be a Joint Patent Right and becoming the patent right solely of the Continuing Party as of the date of such written notice from the Declining Party, and (iii) for clarity, if the Declining Party is LICENSEE and such Joint Patent Right would otherwise thereafter be a Patent Right or Future Patent Right, then [***].

8.        ACTUAL OR THREATENED INFRINGEMENT, DISCLOSURE OR MISAPPROPRIATION; DEFENSE ACTIONS; ORANGE BOOK LISTINGS; AND PATENT TERM EXTENSION

 	8.1.	Notice. Each Party will promptly notify the other Party in writing of (a) any actual or threatened infringement, misappropriation, other violation, or challenge to the validity, scope or enforceability by a Third Party of any Licensed Technology in the Territory of which it becomes aware (“Third Party Infringement”) and (b) any allegation by a Third Party that any Intellectual Property Right owned by it is infringed, misappropriated, or otherwise violated by the Development, Commercialization, and/or Use of any Product of which it becomes aware (“Defense Action”).

8.2.	Licensee Control. LICENSEE shall have the first right (but not the obligation), at its own expense, to control enforcement of the Licensed Technology against any Third Party Infringement. Prior to commencing involvement in any such suit, action or proceeding, LICENSEE shall consult with PFIZER and shall consider PFIZER’s timely recommendations regarding the proposed suit, action or
 
24

 	proceeding, except to the extent delay may reasonably result in the loss of rights by or otherwise adversely impact LICENSEE or PFIZER. LICENSEE shall give PFIZER timely notice of any proposed settlement of any such suit, action or proceeding that LICENSEE controls and LICENSEE shall not settle, stipulate to any facts or make any admission with respect to any Third Party Infringement without PFIZER’s prior written consent (not to be unreasonably withheld) if such settlement, stipulation or admission would: (a) adversely affect the validity, enforceability or scope, or admit non-infringement, of any of the Licensed Technology; (b) give rise to liability of PFIZER or its Affiliates; (c) grant to a Third Party a license or covenant not to sue under, or with respect to, any Intellectual Property Rights Controlled by PFIZER or its Affiliates (other than as expressly provided for in this Agreement with respect to LICENSEE’s rights to sublicense the Licensed Technology); or (d) otherwise impair PFIZER’s or any of its Affiliates’ rights in any Licensed Technology or PFIZER’s or any of its Affiliates’ rights in this Agreement.

8.3.	Pfizer Control. PFIZER shall have the right (but not the obligation) to control enforcement of the Licensed Technology against any Third Party Infringement if LICENSEE provides PFIZER with written notice that it is not exercising its right to control such enforcement, or if LICENSEE fails to initiate or file the relevant response to (as applicable), a suit, action or proceeding with respect to such Third Party Infringement prior to or upon the earlier of: (a) expiration of the [***] period following first receipt by either Party of notice from the other Party of such Third Party Infringement or (b) [***] prior to the deadline for filing, or filing the applicable response to (as applicable), such suit, action or proceeding (including suits, actions or proceedings based on a Third Party’s filing of a Paragraph IV Certification under 21 CFR §314.94(a)(12)(i)(A)(4))).

8.4.	Rights of Non-Controlling Party. Notwithstanding anything to the contrary herein, the Party that is not controlling the suit, action or proceeding pertaining to enforcement of the Licensed Technology against Third Party Infringement as described in this Section 8 shall join as a party to such suit, action or proceeding upon the reasonable request and expense of the Party controlling such action if necessary for standing purposes. The Party that is not controlling such a suit, action or proceeding shall have the right to be represented by counsel (which shall act in an advisory capacity only, except for matters solely directed to such Party) of its own choice and at its own expense (subject to Section 8.5) in any such suit, action or proceeding.

8.5.	Recoveries. Any and all recoveries resulting from a suit, action or proceeding relating to a claim of Third Party Infringement shall first be applied to reimburse each Party’s costs and expenses in connection with such suit, action or proceeding, with any remaining recoveries (the “Remaining Recoveries”) allocated (i) if the controlling Party is LICENSEE, [***], with [***], and (ii) if the controlling Party is PFIZER [***].
 
 	8.6.	Defense. Upon LICENSEE’s request, PFIZER will reasonably cooperate with
 
25

 	LICENSEE, at LICENSEE’s expense, to the extent necessary to defend LICENSEE or any Affiliate or sublicensee of LICENSEE in a Defense Action in which the claim of infringement, misappropriation or other violation is directed at LICENSEE’s or its sublicensee’s Use of a Compound (as such Compound exists as of the Execution Date) or the Know-How (in accordance with Section 2). LICENSEE shall have all authority with respect to any Defense Action, including the right to exclusive control of the defense of any such suit, action or proceeding and the exclusive right to compromise, litigate, settle or otherwise dispose of any such suit, action, or proceeding; provided that LICENSEE shall keep PFIZER timely informed of the proceedings and filings, and provide PFIZER with copies of all communications pertaining to each Defense Action and LICENSEE shall not settle, stipulate to any facts or make any admission with respect to any Defense Action without PFIZER’s prior written consent if such settlement, stipulation or admission would: (a) adversely affect the validity, enforceability or scope, or admit non-infringement, of any of the Licensed Technology; (b) give rise to liability of PFIZER or its Affiliates; (c) grant to a Third Party a license or covenant not to sue under, or with respect to, any Intellectual Property Rights Controlled by PFIZER or its Affiliates, other than as expressly provided for in this Agreement with respect to LICENSEE’s rights to sublicense the Licensed Technology; or (d) otherwise impair PFIZER’s or any of its Affiliates’ rights in any Licensed Technology or PFIZER’s or any of its Affiliates’ rights in this Agreement.

 	8.7.	Orange Book Listings. To the extent required by or permitted by Applicable Law, LICENSEE will have the right to decide whether to list with the applicable Regulatory Authorities during the term of this Agreement any applicable Patent Rights for a Compound or Product that has become the subject of an application for Regulatory Approval submitted to FDA. Such listings may include without limitation all so-called “Orange Book” listings required under the Hatch-Waxman Act and all so-called “Patent Register” listings as required in Canada. PFIZER will reasonably cooperate, at LICENSEE’s request and expense, in preparing and/or filing such listings within the time frames available or required for such listings to be submitted in connection with such Compound and/or Product. LICENSEE may request in writing that [***], in order for it to be listed with the applicable Regulatory Authorities under this paragraph. In such case, PFIZER shall not unreasonably withhold its consent to such [***]; provided that if PFIZER reasonably believes it might want to list such [***] with the Regulatory Authorities for products other than Products, then it may withhold its consent without further explanation.

8.8.	Patent Term Extension. LICENSEE shall notify PFIZER of the date of Regulatory Approval of a Product by the relevant Regulatory Authority. LICENSEE shall have the right to prepare and file, or to cause PFIZER to prepare and file (at LICENSEE’s request and expense), a patent term extension or supplementary protection certificate application upon Regulatory Approval of such Product. At LICENSEE’s request and expense, PFIZER shall provide to
 
26

LICENSEE for inclusion in such filing any information not in LICENSEE’s possession relating to the regulatory timeline, diligence and regulatory period calculations required as part of the application to complete such application(s), and otherwise reasonably cooperate in any other matters related to preparation or filing of the application(s) therefor to make such filing within the applicable time period.
 
9.	CONFIDENTIALITY

9.1.	Definition. “Confidential Information” means the terms and provisions of this Agreement and other proprietary information and data of a financial, commercial or technical nature (including such information or data of or relating to a Third Party) that the disclosing Party or any of its Affiliates has supplied or otherwise made available to the other Party or its Affiliates, which are disclosed, whether orally, visually or in writing. All Know-How shall be considered PFIZER’s Confidential Information.

 	9.2.	Obligations. During the term of this Agreement and for five (5) years thereafter, the receiving Party will (a) protect all Confidential Information of the disclosing Party against unauthorized disclosure to Third Parties, and (b) not use the Confidential Information of the disclosing Party except as permitted by or in furtherance of exercising rights or carrying out obligations hereunder. Each receiving Party will treat Confidential Information provided by the other Party with the same degree of care as if it were the receiving Party’s own confidential information (but under no circumstances less than reasonable care). The receiving Party may disclose the Confidential Information of the disclosing Party to its Affiliates, and their respective directors, officers, employees, subcontractors, sublicensees, consultants, attorneys, accountants, banks, acquirers and investors (collectively, “Recipients”) who have a need-to-know such information for purposes related to this Agreement, provided that the receiving Party shall hold such Recipients to written obligations of confidentiality with terms and conditions at least as restrictive as those set forth in this Agreement.

9.3.	Exceptions.
9.3.1. The obligations under this Section 9 shall not apply to any information to the extent the receiving Party can demonstrate by competent evidence that such information:

 	(a)	is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by the receiving Party or any Recipients to whom it disclosed such information;
 
 	(b)	was known to, or was otherwise in the possession of, the receiving Party prior to the time of disclosure by the disclosing Party other than under obligations of confidentiality;
 
27

(c)	is disclosed to the receiving Party on a non-confidential basis by a Third Party who is entitled to disclose it without breaching any confidentiality obligation to the disclosing Party; or
 
 	(d)	is independently developed by or on behalf of the receiving Party or any of its Affiliates, as evidenced by its written records, without use or access to the Confidential Information.

9.3.2. The restrictions set forth in this Section 9 shall not prohibit the receiving Party from disclosing or using (as specified below) any Confidential Information of the disclosing Party (i) that the receiving Party is required to disclose under Applicable Laws, a court order or other governmental order, or the rules and regulations of the Securities and Exchange Commission (“SEC”) or any national securities exchange, (ii) that the receiving Party needs to disclose or use to file, prosecute or enforce any Patent Rights under Sections 7 and 8, or (iii) that LICENSEE, as receiving Party, needs to disclose or use for purposes of obtaining or maintaining Regulatory Approval of Products; provided that the receiving Party (a) as to subsection (i), provides the disclosing Party at least [***] prior written notice of such disclosure (and the right to review and comment on the proposed disclosure), to the extent practicable, (b) as to subsection (i), affords the disclosing Party an opportunity to oppose or limit, or secure confidential treatment for such required disclosure or, for submissions or disclosures required by the SEC or national securities exchange, itself uses reasonable efforts to secure confidential treatment for such required disclosure, (c) as to subsection (i) discloses only that portion of the Confidential Information that the receiving Party is legally required to disclose as advised by the receiving Party’s legal counsel and (d) as to subsections (ii) and (iii), the receiving Party provides reasonable advance notice to the other Party where reasonably practicable and discloses only that portion of the Confidential Information that it is reasonably necessary to disclose for such purpose.

9.3.3. In the event that PFIZER wishes to assign, pledge or otherwise transfer its rights to receive some or all of the Milestone Payments and Royalties payable hereunder, PFIZER may disclose to a Third Party Confidential Information of LICENSEE in connection with any such proposed assignment, pledge or transfer, provided that PFIZER shall hold such Third Parties to written obligations of confidentiality with terms and conditions at least as restrictive as those set forth in this Agreement. To the extent that any such assignment would affect LICENSEE’s performance of its obligations hereunder, PFIZER shall notify LICENSEE promptly if it enters into any agreement under which it has assigned its rights to receive some or all of the Milestone Payments and Royalties payable hereunder.

9.4.	Right to Injunctive Relief. Each Party agrees that breaches of this Section 9 may cause irreparable harm to the disclosing Party and may entitle the disclosing Party, in addition to any other remedies available to it (subject to the terms of this Agreement), the right to seek injunctive relief enjoining such action.
 
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9.5.	Ongoing Obligation for Confidentiality. Upon expiration or termination of this Agreement, the receiving Party shall, and shall cause its Recipients to, destroy, delete, or return (as requested by the disclosing Party) any Confidential Information of the disclosing Party, except for one copy which may be retained in its confidential files for archive purposes.
 
 	9.6.	Specific Procedures in Regard to Financing. Any disclosure made by LICENSEE to prospective investors or others in connection with the financing LICENSEE expects to complete in order to satisfy the Financing Condition shall be made only pursuant to Confidentiality and Non-Disclosure Agreements or other arrangements in form and substance satisfactory to PFIZER.
 
10.    REPRESENTATIONS,	WARRANTIES AND COVENANTS

10.1.	Representations and Warranties by Each Party. Each Party represents and warrants to the other Party as of the Execution Date (and from and after the Closing, as of the Closing Date, subject to Sections 2.7.2 and 2.7.3) that:
10.1.1. it is a corporation duly organized, validly existing, and in good standing under the laws of its jurisdiction of formation;

10.1.2. it has full corporate power and authority to execute, deliver, and perform under this Agreement, and has taken all corporate action required by Applicable Law and its organizational documents to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement;

10.1.3. this Agreement constitutes a valid and binding agreement enforceable against it in accordance with its terms;

10.1.4. all consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained; and

10.1.5. the execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement, and the consummation of the transactions contemplated hereby do not and shall not: (i) conflict with or result in a breach of any provision of its organizational documents, (ii) result in a breach of any agreement to which it is a party that would impair the performance of its obligations hereunder; or (iii) violate any Applicable Law.

10.2.	Representations and Warranties by PFIZER. PFIZER represents and warrants to LICENSEE as of the Execution Date (and from and after the Closing, as of the Closing Date, subject to Sections 2.7.2 and 2.7.3) that:
 
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10.2.1. to its Knowledge, the Use of an Existing Product in the form existing as of the Execution Date within the Territory will not infringe, misappropriate or otherwise violate the Intellectual Property Rights of a Third Party;

10.2.2. to its Knowledge, the Use of an Existing Product on or prior to the Execution Date did not infringe, misappropriate or otherwise violate the Intellectual Property Rights of any Third Party;

10.2.3. to its Knowledge, no Third Party is or was infringing, misappropriating or otherwise violating the Licensed Technology within the Territory;

10.2.4. neither PFIZER nor its Affiliates [***] has received [***], and no such entity has [***] of an Existing Product;

10.2.5. to its Knowledge, no Third Parties have any right, title or interest in or to any Patent Right existing as of the Execution Date that claims an Existing Product, or the use or manufacture thereof, other than MGH;

10.2.6. The HKI-357 Compound is the only Back-up Compound for the Neratinib Compound. As used herein, the terms “HKI-357 Compound” and “Neratinib Compound” have the meaning set forth in the definition of “Compound” in Section 1, and “Back-up Compound” means, [***];

10.2.7. PFIZER has not [***] in connection with an Existing Product any [***] that have been or are [***];

10.2.8. PFIZER has not received any notices of [***] with respect to the [***] of a Compound or Existing Product that could reasonably be deemed to adversely affect the [***];

10.2.9. All [***] PFIZER or its Affiliates conducting activities prior to the Execution Date with respect to any Compound or Existing Product have [***] PFIZER or its Affiliate, as applicable, of [***] in connection with the activities [***] conducted with respect to any Compound or Existing Product, [***], if any, to PFIZER or its Affiliate, as applicable, [***];

10.2.10. PFIZER is not a party to any litigation in which any Third Party has alleged that the Use of an Existing Product within the Territory (a) [***] or (b) infringes, misappropriates or otherwise violates the Intellectual Property Rights of such Third Party; and

10.2.11. To the extent material to Development of the Compounds or Existing Product, all [***] by or on behalf of PFIZER or its Affiliates prior to the Execution Date in the course of developing the Compounds or Existing Product have been [***].

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 	10.3.	Representations, Warranties and Covenants by LICENSEE and Covenants of PFIZER.

10.3.1. LICENSEE represents, warrants and covenants to PFIZER that, to the extent material to Use of the Compounds and the Products, it shall, and shall ensure all Third Parties that it engages with respect to activities directed to the Compounds and the Products shall, comply in all material respects with all Applicable Laws with respect to its activities and the performance of its obligations hereunder.

10.3.2. Without limiting the generality of Section 10.3.1, LICENSEE shall comply with the U.S. Foreign Corrupt Practices Act of 1977 (as modified or amended). LICENSEE represents, warrants and covenants that it has not and will not directly or indirectly offer or pay, or authorize such offer or payment of, any money, or transfer anything of value, to improperly seek to influence any Government Official.

10.3.3. LICENSEE covenants that it will not utilize, in conducting Development or Commercialization of Product, any person or entities that at such time are debarred by FDA, or that, at such time, are under investigation by FDA for debarment action pursuant to the provisions of the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335).

10.3.4. LICENSEE covenants that all employees, officers, contractors, and consultants of LICENSEE or its Affiliates working under this Agreement shall execute agreements requiring assignment to LICENSEE of all right, title and interest in and to their inventions and discoveries invented or otherwise discovered or generated during the course of and as a result of their association with LICENSEE, whether or not patentable, if any, to LICENSEE as the sole owner thereof.

10.3.5. PFIZER shall conduct all Trial Completion Activities or activities under the Transition Plan in material compliance with all Applicable Laws and shall not, to its Knowledge, utilize any person or entity to perform and such activities that has been or is debarred by FDA pursuant to the provisions of the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335).

10.4.	No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 10, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO WARRANTIES OF TITLE, NON-INFRINGEMENT, VALIDITY, ENFORCEABILITY, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. ANY INFORMATION PROVIDED BY PFIZER OR ITS AFFILIATES IS MADE AVAILABLE ON AN “AS IS” BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS, COMPLIANCE WITH REGULATORY STANDARDS, REGULATIONS OR APPLICABLE LAW OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED.
 
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 	11.1.	Indemnification by LICENSEE. From and after the Closing, LICENSEE agrees to indemnify, hold harmless and defend PFIZER and its Affiliates, and their respective officers, directors, employees, contractors, agents and assigns (collectively, “PFIZER Indemnitees”), from and against any Claims to the extent arising or resulting from: (a) the Development, Commercialization and other Use of Products by LICENSEE, its Affiliates, subcontractors or sublicensees, (b) LICENSEE’s, its Affiliates’, subcontractors’ and sublicensees’ performance of Trial Completion Activities or activities under the Transition Plan, (c) the gross negligence or wrongful intentional acts or omissions of LICENSEE, its Affiliates, subcontractors or sublicensees, (d) breach by LICENSEE of any representation, warranty, obligation or covenant as set forth in this Agreement, (e) breach by LICENSEE of the scope of the license set forth in Section 2.1 or (f) PFIZER’s conduct after the Closing of the Trial Completion Activities, activities under the Transition Plan or the [***], except (in the case of (f)) to the extent that PFIZER is obligated to indemnify LICENSEE with respect to any such activity or service under the provisions of Section 11.2. As used herein, “Claims” means collectively, any and all Third Party demands, claims, actions and proceedings (whether criminal or civil, in contract, tort or otherwise) for losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees).

11.2.	Indemnification by PFIZER. From and after the Closing, PFIZER agrees to indemnify, hold harmless and defend LICENSEE and its Affiliates and sublicensees, and their respective officers, directors, employees, contractors, agents and assigns (collectively, “LICENSEE Indemnitees”), from and against any Claims to the extent arising or resulting from (a) the Development and other Use of Compounds and Products by PFIZER, its Affiliates, subcontractors or sublicensees prior to the Closing Date, (b) the gross negligence or wrongful intentional acts or omissions of PFIZER, its Affiliates, or subcontractors, or (c) breach by PFIZER of any representation, warranty, obligation or covenant as set forth in this Agreement.

11.3.	Indemnification Procedure. In connection with any Claim for which a Party (the “Indemnified Party”) seeks indemnification from the other Party (the “Indemnifying Party”) pursuant to this Agreement, the Indemnified Party shall: (a) give the Indemnifying Party prompt written notice of the Claim; provided, however, that failure to provide such notice shall not relieve the Indemnifying Party from its liability or obligation hereunder, except to the extent of any material prejudice as a direct result of such failure; (b) cooperate with the Indemnifying Party, at the Indemnifying Party’s expense, in connection with the defense and settlement of the Claim; and (c) permit the Indemnifying Party to control the defense and settlement of the Claim only if the Indemnifying Party

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confirms in writing that it is liable to indemnify the PFIZER Indemnitees or the LICENSEE Indemnitees, as applicable, in connection with the relevant matter and provides reasonable substantiation that the Indemnifying Party has the financial resources to pay for the defense and settlement of the Claim (including any settlement thereof or judgment thereon); provided, however, that the Indemnifying Party may not settle the Claim without the Indemnified Party’s prior written consent, which shall not be unreasonably withheld or delayed, in the event such settlement materially adversely impacts the Indemnified Party’s rights or obligations. Further, the Indemnified Party shall have the right to participate (but not control) and be represented in any suit or action by advisory counsel of its selection and at its own expense.
 
12.	LIMITATION OF LIABILITY

12.1.	No Consequential Damages. EXCEPT FOR A BREACH OF SECTION 2.1 OR SECTION 9 OR OBLIGATIONS ARISING UNDER SECTION 11, NEITHER PARTY SHALL BE LIABLE FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES, INCLUDING DAMAGES FOR LOST PROFITS OR LOST REVENUES REGARDLESS OF WHETHER IT HAS BEEN INFORMED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES OR THE TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING NEGLIGENCE).
 
13.	TERM; TERMINATION
 
 	13.1.	Term. The term of this Agreement shall commence as of the Execution Date and unless earlier terminated as expressly provided herein, shall expire upon the last-to-expire Royalty Term.
 
 	13.2.	Termination by LICENSEE.

13.2.1. Termination At Will. LICENSEE may, provided that LICENSEE is not then in material breach of this Agreement, terminate this Agreement in its entirety at will, in its sole discretion, at any time on or after the date that is eighteen (18) months after the Closing Date on not less than one hundred eighty (180) days prior written notice to PFIZER.
 
 	  	13.2.2. Termination for Safety Concerns. LICENSEE may terminate this Agreement in its entirety on not less than sixty (60) days prior written notice to PFIZER if LICENSEE has evidence of safety issues on the basis of which a reasonable investigator would conclude that such issues will prevent the successful Development and Commercialization of Products hereunder. LICENSEE shall provide such evidence to PFIZER together with such notice and shall discuss such evidence as reasonably requested by PFIZER.

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 	  	13.2.3. Termination Generally. This Agreement may not be terminated by LICENSEE under this Section 13.2 on a Compound-by-Compound, or country-by-country or other partial basis.

 	13.3.	Termination for Cause. Each Party shall have the right, without prejudice to any other remedies available to it at law or in equity, to terminate this Agreement in the event the other Party breaches any of its material obligations hereunder and fails to cure such breach within thirty (30) days of receiving notice thereof; provided, however, if such breach is capable of being cured, but cannot be cured within such thirty (30) day period, and the breaching Party initiates actions to cure such breach within such period and thereafter diligently pursues such actions, the breaching Party shall have such additional period as is reasonable to cure such breach, but in no event will such additional period exceed sixty (60) days unless otherwise agreed in writing by the Parties. Any termination by a Party under this Section 13.3 shall be without prejudice to any damages or other legal or equitable remedies to which it may be entitled from the other Party. For the avoidance of doubt, LICENSEE’s failure to use Commercially Reasonable Efforts to Develop and Commercialize Products in each Major Market Country shall constitute a breach of a material obligation by LICENSEE under this Agreement.

 	13.4.	Termination for a Bankruptcy Event. PFIZER shall have the right to terminate this Agreement by written notice to LICENSEE in the event of a Bankruptcy Event. “Bankruptcy Event” means the occurrence of any of the following: (a) the institution of any bankruptcy, receivership, insolvency, reorganization or other similar proceedings by or against LICENSEE under any bankruptcy, insolvency, or other similar law now or hereinafter in effect, including any section or chapter of the United States Bankruptcy Code, as amended or under any similar laws or statutes of the United States or any state thereof (the “Bankruptcy Code”), where in the case of involuntary proceedings such proceedings have not been dismissed or discharged within ninety (90) days after they are instituted, (b) the insolvency or making of an assignment for the benefit of creditors or the admittance by LICENSEE of any involuntary debts as they mature, (c) the institution of any reorganization, arrangement or other readjustment of debt plan of LICENSEE not involving the Bankruptcy Code, (d) appointment of a receiver for all or substantially all of LICENSEE’s assets, or (e) any corporate action taken by the board of directors of LICENSEE in furtherance of any of the foregoing actions.

13.5.	Termination for Closing Failure. This Agreement shall terminate as set forth in Section 2.7.1.
 
 	13.6.	Effect of Termination or Expiration.
 
 	  	13.6.1. Upon termination or expiration of this Agreement, LICENSEE shall pay to PFIZER all amounts due to PFIZER as of the effective date of termination or expiration within thirty (30) days following the effective date of termination or expiration.
 
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13.6.2. Upon expiration of this Agreement pursuant to Section 13.1, PFIZER hereby grants to LICENSEE a royalty-free right and license to use the Know-How for the purpose of the Development and Commercialization of Compounds and Products within the Territory.

13.6.3. Upon termination of this Agreement, LICENSEE shall have the right to sell its remaining inventory of Products following the termination of this Agreement so long as LICENSEE has fully paid, and continues to fully pay when due, any and all Royalties and Milestone Payments owed to PFIZER, and LICENSEE otherwise is not in material breach of this Agreement.

13.6.4. Subject to Section 13.6.3, upon termination of this Agreement all licenses granted by PFIZER to LICENSEE shall terminate. For clarity, termination of the licenses granted by PFIZER to LICENSEE shall [***]. At LICENSEE’s request, [***]: (i) PFIZER shall [***] and (ii) if it is [***]; provided that PFIZER shall have [***].

13.6.5. With the exception of termination of this Agreement by LICENSEE pursuant to Section 13.3, upon termination of this Agreement:

(a)	LICENSEE hereby grants to PFIZER a [***], worldwide, transferable, perpetual and irrevocable license, with the right to sublicense, under any Intellectual Property Rights Controlled by LICENSEE claiming Inventions that are necessary or reasonably useful for the Development, Commercialization or other Use of Products as they exist at the time of such termination of this Agreement, including without limitation, any and all Developed IP (as defined in Section 7.3), to Develop, Commercialize and otherwise Use the Products.

(b)	To the extent permitted by applicable Regulatory Authorities and requested by PFIZER, LICENSEE shall: (i) transfer to PFIZER all Regulatory Filings and Regulatory Approvals held by LICENSEE with respect to Products, and (ii) to the extent subsection (i) is not permitted by the applicable Regulatory Authority, permit PFIZER to cross-reference and rely upon any Regulatory Approvals and Regulatory Filings filed by LICENSEE with respect to Products.
 
 	(c)	LICENSEE, if requested in writing by PFIZER, shall provide any and all (i) material correspondence with the relevant patent offices pertaining to the LICENSEE’s prosecution of the Patent Rights to the extent not previously provided to PFIZER during the course of the Agreement, and (ii) a report detailing the status of all Patent Rights at the time of termination or expiration.

(d)	LICENSEE hereby grants to PFIZER a [***], worldwide, transferable, sublicensable, perpetual and irrevocable license to use the Trademarks specifically identifying each Product, excluding for clarity all Trademarks
 
35

 	also used in connection with LICENSEE’s business other than with respect to Product, for the purpose of manufacturing, marketing, distributing, selling, and otherwise Developing and Commercializing, such Product. As used herein, “Trademarks” means all registered and unregistered trademarks, service marks, trade dress, trade names, logos, insignias, domain names, symbols, designs, and combinations thereof.

 	(e)	At PFIZER’s option on a study-by-study basis for any study then on-going, and to the extent permitted under applicable agreements, LICENSEE will take such actions as PFIZER may reasonably request, at PFIZER’s expense, to allow PFIZER or its CRO to complete the applicable study and to assign all related Regulatory Filings and Regulatory Approvals and investigator and other agreements relating to such study to PFIZER. LICENSEE shall, at PFIZER’s request (to be made within thirty (30) days after the effective date of termination of this Agreement), (i) transfer to PFIZER or its Affiliate or designee all Inventory then owned and possessed by LICENSEE provided that PFIZER shall reimburse LICENSEE’s direct costs thereof, and (ii) assign to PFIZER or its Affiliate or designee any agreements with Third Parties with respect to the Development or Commercialization of Products to the extent permitted under the terms of such agreements. As used herein, “Inventory” means all Products and components and works in process produced by or on behalf of LICENSEE with respect to the manufacture of Products.

 	13.7.	Survival. Any expiration or termination of this Agreement shall not preclude the terminating Party from exercising any other of those remedies to which it may be entitled under this Agreement or Applicable Law, or terminate any right to obtain performance of any obligation provided for in this Agreement that shall survive termination. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing hereunder prior to such expiration or termination. Without limiting the foregoing, the provisions of Sections 2.3, 2.4, 2.5, 2.6, 3.6 (solely as to subsections 3.6.3-3.6.5 thereof and the first two sentences of Section 3.6 as they relate to such subsections (including, for clarity, LICENSEE’s obligations under Schedule C), provided that Section 3.6 will not survive if this Agreement is terminated by LICENSEE under Section 13.3 because of material breach by PFIZER), 6, 7.1, 7.2, 7.4.3, 9, 10.4, 11 (as to claims arising with respect to activities occurring during the term of this Agreement), 12, 13.6, 13.7, 14.2, 15, 16, 17.1-17.8, and 17.10-17.15 shall survive expiration or termination of this Agreement.

14.	PUBLICITY AND PUBLICATIONS
 
 	14.1.	Publicity.
 
 	  	14.1.1. Subject to PFIZER’s rights pursuant to Section 13.6.5(d) and except as expressly permitted in Section 14.1.2, neither Party (nor any of its Affiliates or
 
36

 	agents) shall use the Trademarks of the other Party or its Affiliates in any press release, publication or other form of promotional disclosure without the prior written consent of the other Party in each instance.

 	  	14.1.2. Each Party agrees not to issue any press release or other public statement, whether written, electronic, oral or otherwise, disclosing the existence of this Agreement, the terms hereof or any information relating to this Agreement without the prior written consent of the other Party, provided however, that (a) on the Closing Date, PFIZER at its option will, and LICENSEE will, each issue a global press release (collectively, the “Global Press Releases”), (b) contemporaneously with the issuance of the Global Press Releases, PFIZER will send on behalf of LICENSEE written communications to investigators of the Existing Trials (the “Investigator Communications”), and (c) neither Party will be prevented from complying with any duty of disclosure it may have pursuant to Applicable Laws or the rules and regulations of the SEC or any national securities exchange so long as the disclosing Party provides the other Party at least [***] prior written notice (and the right to review and comment on the proposed disclosure), to the extent practicable, and only discloses information to the extent required by Applicable Law or the rules and regulations of the SEC or national securities exchange, as set forth in Section 9.3. The content of the Global Press Releases and Investigator Communications shall be reasonably agreed-upon by the Parties prior to the Closing Date and shall describe (i) the fact that the Existing Advanced Trial described in clause (a) of the definition of “Existing Advanced Trial” is being amended as set forth in Attachment C-1 to Schedule C and (ii) LICENSEE’s proposed development plan for Products.

 	14.2.	Publications. LICENSEE acknowledges that PFIZER personnel may desire to publish in scientific journals or present at scientific conferences scientific, pre-clinical or clinical data derived from research and development related to the Compounds that was conducted by PFIZER prior to the Closing Date. PFIZER acknowledges that LICENSEE personnel may desire to publish in scientific journals or present at scientific conferences results of LICENSEE’s Development activities hereunder. Both Parties understand that a reasonable commercial strategy may require delay of publication of information or filing of patent applications. Accordingly, from and after the Closing Date, no such publication will be submitted and no such presentation shall be made without the prior written consent of the other Party. Any such publication or presentation shall be submitted in writing to the other Party for review by the other Party reasonably in advance of the proposed publication or presentation date. The reviewing Party will reasonably consider such publication or presentation request, but shall not be obligated to consent thereto, and such reviewing Party shall provide its consent to or denial of such request within thirty (30) days of its receipt of such proposed publication or presentation. The Parties will reasonably agree upon appropriate authorship of any publication to which the other Party consents. In addition, from and after the Closing Date, if any PFIZER publication resulting from research in which PFIZER exercises the PFIZER Retained Rights under Section 2.3 mentions

37

 	the Neratinib Compound, PFIZER will notify LICENSEE in advance of publication and provide LICENSEE the opportunity to comment on such publication. The Parties will discuss their publications plans at Transition Committee meetings.
 
15.	LICENSEE INSURANCE

 	15.1.	Insurance Requirements. LICENSEE will maintain at all times during the term of this Agreement immediately prior to the date that it becomes the sponsor of an IND for Product pursuant to Section 4.3.2, and until the later of: (a) [***] after termination or expiration of this Agreement, or (b) the date that all statutes of limitation covering claims or suits that may be instituted for personal injury based on the sale or use of the Product have expired, commercial general liability insurance from a minimum “A-” AM Bests rated insurance company, including contractual liability and product or clinical trials liability, if applicable, with coverage limits of not less than [***] in the aggregate. LICENSEE has the right to provide the total limits required by any combination of primary and umbrella/excess coverage. The minimum level of insurance set forth herein shall not be construed to create a limit on LICENSEE’s liability hereunder. Such insurance policies shall be primary and non-contributing with respect to any other similar insurance policies available to the PFIZER Indemnitees. Any deductibles for such insurance shall be assumed by LICENSEE.

15.2.	Policy Notification. LICENSEE shall provide PFIZER with certified copies of such policies or original certificates of insurance evidencing such insurance: (a) promptly following execution by both Parties of this Agreement, and (b) prior to expiration of any one type of coverage. LICENSEE shall provide to PFIZER at least [***] written notice prior to cancellation, termination or any change to restrict the coverage or reduce the limits afforded ; provided that no such notice shall be required if LICENSEE does or will have other or additional coverage in place prior to such cancellation, termination or change that results in LICENSEE having overall insurance coverage that complies with Section 15.1.
 
16.	DISPUTE RESOLUTION

16.1.	General. Except for disputes for which injunctive or other equitable relief is sought to prevent the unauthorized use or disclosure of proprietary materials or information or prevent the infringement or misappropriation of a Party’s Intellectual Property Rights, the following procedures shall be used to resolve any dispute arising out of or in connection with this Agreement.
 
 	16.2.	Dispute Escalation. Promptly after the written request of either Party, except with respect to activities conducted pursuant to the Transition Plan or the Trial Completion Plan, or [***], each of the Parties shall appoint a designated representative to meet in person or by telephone to attempt in good faith to resolve any dispute. If the designated representatives do not resolve the dispute within [***] of such request, or if such dispute arises with respect to activities

38

 	conducted pursuant to the Transition Plan or the Trial Completion Plan, or [***], then the CEO of LICENSEE and the President of PFIZER’s Oncology Business Unit (collectively, the “DR Executives”) shall meet in person or by telephone to review and attempt to resolve the dispute in good faith. The DR Executives shall have [***] (except as provided in Section 16.4) to attempt to resolve the dispute.

16.3.	Pursuit of Claims. With respect to any dispute that is not resolved by the Parties as set forth above, except as expressly set forth in Section 16.4 and Section 16.5, each Party may pursue claims it has under applicable law, which may include filing suit in courts of competent jurisdiction.

16.4.	Disputes Arising Under Transition Plan, Trial Completion Plan, or [***]. Any disputes arising with respect to activities conducted pursuant to the Transition Plan or the Trial Completion Plan, or [***], but no other disputes arising under this Agreement, shall be submitted for expedited resolution as provided in this Section 16.4 and Section 16.5 if applicable. First, such dispute shall be submitted directly for resolution by the DR Executives pursuant to Section 16.2, except that the [***] time period shall be [***]. If the DR Executives do not resolve such dispute within such [***] time period, then either Party may submit the issue for resolution pursuant to Section 16.5.

 	16.5.	Expedited Resolution of Transition Plan, Trial Completion Plan and [***] Disputes. Any disputes arising with respect to activities conducted pursuant to the Transition Plan or the Trial Completion Plan, or [***], that remain unresolved after following the procedures set forth in Section 16.4, but no other issues arising under this Agreement, shall be submitted for resolution by expedited arbitration pursuant to this Section 16.5. Any arbitration under this Section 16.5 shall be conducted by [***]. In such arbitration, [***] shall select an independent expert with significant experience relating to the subject matter of such dispute in the life sciences industry, at a senior executive level, to advise the arbitrator with respect to the subject matter of the dispute. If the Parties are unable to agree on an arbitrator, the arbitrator shall be selected [***]. The arbitrator and such expert shall be selected within [***] after the matter is submitted for arbitration, and such arbitrator and expert shall issue their decision as promptly as practicable, but no later than [***] after they have both been selected. The Parties agree that the arbitrator shall have the power to resolve any disputes to be resolved pursuant to this Section 16.5 based on principles of fairness and equity. Each Party shall bear its own costs and expenses in connection with the arbitration.

17.	GENERAL PROVISIONS
 
 	17.1.	Assignment. Neither Party may assign its rights and obligations under this Agreement without the other Party’s prior written consent, except that: (a) PFIZER may assign to a Third Party its rights to receive some or all of the Milestone Payments and Royalties payable hereunder, provided that doing so does not adversely affect in any material respect the payment or other obligations of LICENSEE hereunder; (b) each Party may assign its rights and obligations
 
39

 	under this Agreement to one or more of its Affiliates without the consent of the other Party, provided that such assignment does not increase materially the other Party’s payment obligations (including without limitation such other Party’s tax payment obligations) ; and (c) either Party may assign this Agreement to the successor entity in the event it undergoes a Change in Control. As used herein, “Change in Control” means the acquisition of a Party by a Third Party or the sale of all or substantially all of its business to which this Agreement relates. The assigning Party shall provide the other Party with prompt written notice of any such assignment. Any permitted assignee pursuant to clauses (b) and (c) above shall assume all obligations of its assignor under this Agreement, and no permitted assignment shall relieve the assignor of liability for its obligations hereunder. Any attempted assignment in contravention of the foregoing shall be void.

17.2.	Severability. Should one or more of the provisions of this Agreement become void or unenforceable as a matter of law, then such provision will be ineffective only to the extent of such invalidity or unenforceability, without invalidating the remainder of this Agreement, and the Parties agree to substitute a valid and enforceable provision therefor which, as nearly as possible, achieves the desired economic effect and mutual understanding of the Parties under this Agreement.
 
 	17.3.	Governing Law; Exclusive Jurisdiction.
 
 	    	17.3.1. This Agreement shall be governed by and construed under the laws in effect in the State of New York, US, without giving effect to any conflicts of laws provision thereof or of any other jurisdiction that would produce a contrary result.

17.3.2. The courts of the State of New York, US, shall have exclusive jurisdiction over any action brought to enforce this Agreement, and each of the Parties hereto irrevocably: (a) submits to such exclusive jurisdiction for such purpose; (b) waives any objection which it may have at any time to the laying of venue of any proceedings brought in such courts; (c) waives any claim that such proceedings have been brought in an inconvenient forum, and (d) further waives the right to object with respect to such proceedings that any such court does not have jurisdiction over such Party. Notwithstanding the foregoing, application may be made to any court of competent jurisdiction with respect to the enforcement of any judgment or award, or the pursuit of injunctive or other equitable relief described in Section 16.1.

17.4.	Force Majeure. Except with respect to delays or nonperformance caused by the negligent or intentional act or omission of a Party, any delay or nonperformance by such Party (other than payment obligations under this Agreement) will not be considered a breach of this Agreement to the extent such delay or nonperformance is caused by acts of God, natural disasters, acts of the government or civil or military authority, fire, floods, epidemics, quarantine, energy crises, war or riots or other similar cause outside of the reasonable control of such Party (each, a
 
40

“Force Majeure Event”), provided that the Party affected by such Force Majeure Event will promptly begin or resume performance as soon as reasonably practicable after the event has abated. If the Force Majeure Event prevents a Party from performing any of its obligations under this Agreement for [***], then the other Party may terminate this Agreement immediately upon written notice to the non-performing Party.

17.5.	Waivers and Amendments. The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver shall be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

17.6.	Relationship of the Parties. Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between PFIZER and LICENSEE, or to constitute one Party as the agent of the other. Moreover, each Party agrees not to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give any Party the power or authority to act for, bind, or commit the other Party.
 
 	17.7.	Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns.

17.8.	Notices. All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when: (a) delivered by hand (with written confirmation of receipt), (b) sent by fax (with written confirmation of receipt), provided that a copy is sent by an internationally recognized overnight delivery service (receipt requested), or (c) when received by the addressee, if sent by an internationally recognized overnight delivery service (receipt requested), in each case to the appropriate addresses and fax numbers set forth below (or to such other addresses and fax numbers as a Party may designate by written notice):
 
If to PFIZER:

Pfizer Inc.

 	235 East 42nd Street
 	
New York, NY 10017

Fax: 646-348-8157

Attention: General Counsel

If to LICENSEE:	 	
 	Puma Biotechnology, Inc.

10940 Wilshire Blvd, Suite 600
 	Los Angeles, CA 90024
 	Attention: Alan Auerbach
 
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With a copy to:	 	
 	Latham & Watkins
 	650 Town Center Drive
 	20th Floor
 	Costa Mesa CA 92626-1925
 	Fax: 714-755-8290
 	
Attention: Charles Ruck

 	17.9.	Further Assurances. LICENSEE and PFIZER hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary or appropriate to carry out the intent and purposes of this Agreement.

17.10.	No Third Party Beneficiary Rights. This Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including, without limitation, any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby.
 
 	17.11.	Entire Agreement; Confidentiality Agreement.

(a)	This Agreement, together with its Schedules, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter, including, without limitation, that certain Confidentiality Agreement by and between the Parties, dated November 23, 2010 (the “CDA”). The Parties acknowledge and agree that, as of the Execution Date, all Confidential Information (as defined in the CDA) disclosed by PFIZER or its Affiliates pursuant to the CDA shall be considered PFIZER’s Confidential Information and subject to the terms set forth in this Agreement.
 
 	(b)	In the event of any conflict between a material provision of this Agreement and any Schedule hereto, the Agreement shall control.

17.12.	Counterparts. 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.
 
 	17.13.	Cumulative Remedies. Unless otherwise expressly set forth herein, no remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under applicable law.
 
42

17.14.	Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, any rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

17.15.	Construction. For purposes of this Agreement: (a) words in the singular shall be held to include the plural and vice versa as the context requires; (b) the words “including” and “include” shall mean “including, without limitation,” unless otherwise specified; (c) the terms “hereof,” “herein,” “herewith,” and “hereunder,” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole and not to any particular provision of this Agreement; and (d) all references to “Section”, “Schedule” and “Exhibit,” unless otherwise specified, are intended to refer to a Section, Schedule or Exhibit of or to this Agreement.
(Signatures on next page)

43

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives as of the Execution Date.

PUMA BIOTECHNOLOGY, INC.	 		 	PFIZER INC.
By:	 	
/s/ Alan Auerbach

 		 	By:	 	
/s/ Garry Nicholson

Name:	 	
Alan Auerbach

 		 	Name:	 	
Garry Nicholson

Title:	 	
CEO, President

 		 	Title:	 	
President, General Manager

EX-10.14 12 d575899dex1014.htm EX-10.14

Exhibit 10.14

[*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT

between

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

and

PRINCIPIA BIOPHARMA INC.

for

RSK Inhibitors and Novel Electrophiles

UC Case Nos. SF2003-057 & SF2009-119

TABLE OF CONTENTS

(continued)

Article No.                     Title	  	Page	 
BACKGROUND

  	 	1	 
1.

  	DEFINITIONS	  	 	3	 
2.

  	GRANT	  	 	10	 
3.

  	SUBLICENSES	  	 	12	 
4.

  	PAYMENT TERMS	  	 	14	 
5.

  	LICENSE ISSUE FEE	  	 	16	 
6.

  	LICENSE MAINTENANCE FEE	  	 	17	 
7.

  	PAYMENTS ON SUBLICENSES	  	 	17	 
8.

  	EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES	  	 	17	 
9.

MILESTONE PAYMENTS	  	 	19	 
10.

  	DUE DILIGENCE	  	 	19	 
11.

  	PROGRESS AND ROYALTY REPORTS	  	 	21	 
12.

  	BOOKS AND RECORDS	  	 	24	 
13.

  	LIFE OF THE AGREEMENT	  	 	24	 
14.

  	TERMINATION BY THE REGENTS	  	 	25	 
15.

  	TERMINATION BY LICENSEE	  	 	26	 
16.

  	DISPOSITION OF LICENSED PRODUCT AND LICENSED SERVICES UPON TERMINATION OR EXPIRATION	  	 	26	 
17.

  	USE OF NAMES AND TRADEMARKS	  	 	27	 
18.

  	LIMITED WARRANTY	  	 	27	 
19.

  	LIMITATION OF LIABILITY	  	 	28	 
20.

  	PATENT PROSECUTION AND MAINTENANCE	  	 	29	 
21.

  	PATENT MARKING	  	 	31	 
22.

  	PATENT INFRINGEMENT	  	 	31	 
23.

  	INDEMNIFICATION	  	 	33	 
24.

  	NOTICES	  	 	36	 
25.

  	ASSIGNABILITY	  	 	37	 
26.

  	WAIVER	  	 	37	 
27.

  	FORCE MAJEURE	  	 	37	 
28.

  	GOVERNING LAWS; VENUE	  	 	37	 
29.

GOVERNMENT APPROVAL OR REGISTRATION        	  	 	38	 
 
-i-

30.

  	COMPLIANCE WITH LAWS	  	 	38	 
31.

  	CONFIDENTIALITY	  	 	38	 
32.

  	MISCELLANEOUS	  	 	40	 
CONSENT TO SUBSTITUTION OF PARTY

  	 	1	 
 
-ii-

for

“RSK Inhibitors and Novel Electrophiles”

This amended and restated license agreement (“Agreement”) is made effective this 31st day of May, 2012 (“Amendment Effective Date”), by and between The Regents of the University of California, a California corporation, having its statewide administrative offices at 1111 Franklin Street, 12th Floor, Oakland, California 94607-5200 (“The Regents”) and acting through its Office of Technology Management, University of California San Francisco (“UCSF”), 185 Berry Street, Suite 4603, San Francisco, California 94107 and Principia Biopharma Inc., a Delaware corporation, having a principal place of business at 400 East Jamie Court, Suite 302, South San Francisco, California 94080 (“Licensee”).

A. Certain inventions, generally characterized as “Preparation and Use of Selective Serine/Threonine Kinase Inhibitors” (UC Case No. SF2003-057) and “Inhibitors of p90 RSK” (UC Case No. SF2009-119) (collectively “Invention”), were made in the course of research at UCSF by Drs. Kevan Shokat, Michael Cohen, Rebecca Maglathlin, Iana Serafimova, Rand Miller, Ville Paavilainen and Chao Zhang, all employees of UCSF at the time the invention was made, and Dr. Jack Taunton, an employee of the Howard Hughes Medical Institute (“HHMI”) and a faculty member at UCSF, (collectively, the “Inventors”) and are claimed in Patent Rights as defined below.

B. The development of the Invention was sponsored in part by the National Institutes of Health and, as a consequence, this license is subject to overriding obligations to the United States Federal Government under 35 U.S.C. §§ 200-212 and applicable regulations including a non-exclusive, non-transferable, irrevocable, paid-up license to practice or have practiced the Invention for or on behalf of the United States Government throughout the world

1

C. HHMI assigned its rights in the Invention to The Regents under the terms of the interinstitutional agreement with HHMI having UC Control No. 1986-18-0017 (“HHMI Interinstitutional Agreement”), and accordingly, The Regents has the authority to license the entire interest in the Invention and any patent rights claiming the Invention. Under the terms of the HHMI Interinstitutional Agreement, HHMI has reserved nonexclusive, paid-up, royalty-free, irrevocable licenses, with no right to sublicense others, to make and use the invention for research purposes.

D. The Licensee has evaluated the Invention under a Mutual Nondisclosure Agreement with The Regents with an effective date of March 6, 2009.

E. The Licensee and The Regents have executed a Letter of Intent (UC Control No. 2009-30-0052) with an effective date of April 25, 2009.

F. The Licensee wishes to obtain certain rights from The Regents for the commercial development of the Invention, in accordance with the terms and conditions set forth herein and The Regents is willing to grant those rights so that the Invention may be developed and the benefits enjoyed by the general public.

G. The scope of such rights granted by The Regents is intended to extend to the scope of the patents and patent applications in Patent Rights, but only to the extent that The Regents has proprietary rights in and to the Valid Claims of such Patent Rights.

H. The Licensee, as of the Effective Date, is a “small business firm” as defined in 15 U.S.C. §632.

I. Both parties recognize and agree that Earned Royalties are due under this Agreement with respect to products, services and methods and that such royalties will be paid with respect to both pending patent applications and issued patents, in accordance with the terms and conditions set forth herein, it being understood that if royalties are paid under this Agreement for any product, service or method subject to this Agreement, Earned Royalties will not be due under the T3 License Agreement (as defined below) for such product, service or method.

J. Both parties recognize and agree that Earned Royalties due under this Agreement will be based on the Licensee’s or a Sublicensee’s last act of infringement of Patent Rights within the control of the Licensee or a Sublicensee, regardless of whether the Licensee or a Sublicensee had control over prior infringing acts; the parties intend that Earned Royalties due under this Agreement will be calculated based on the Net Sales of the product or service resulting from the last act of infringement by the Licensee and its Sublicensees.

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K. The parties entered into that certain Exclusive License Agreement, dated November 7, 2009 (the “Effective Date”), and amended such agreement on October 14, 2010 and February 9, 2011 (as amended, the “Original Agreement”). The Licensee and The Regents now desire to amend further the Original Agreement, and restate the Original Agreement in its entirety with this Agreement.

L. The parties are also parties to that certain Exclusive License Agreement, dated September 30, 2011 (the “T3 License Agreement”).

— oo 0 oo —

The parties agree as follows:

1.	
DEFINITIONS

As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

1.1 “Affiliate” of the Licensee means any entity which, directly or indirectly, Controls the Licensee, is Controlled by the Licensee or is under common Control with the Licensee. “Control” means (i) having the actual, present capacity to elect a majority of the directors of such entity; (ii) having the power to direct at least fifty percent (50%) of the voting rights entitled to elect directors of such entity; or (iii) in any country where the local law will not permit foreign equity participation of a majority, ownership or control, directly or indirectly, of the maximum percentage of such outstanding stock of such entity or voting rights of such entity as permitted by local law.

1.2 “Attributed Income” means the total gross proceeds (exclusive of Earned Royalties of Sublicensees, but including, without limitation, any license fees, maintenance fees, or milestone payments), whether consisting of cash or any other form of consideration to which a fair market value can be assigned and whether any rights other than Patent Rights are granted, which gross proceeds are received by or payable to the Licensee, any Affiliate and/or Joint Venture from any Sublicensee in consideration of the grant of a sublicense under the license

3

granted by The Regents in Section 2.1. Notwithstanding the foregoing, Attributed Income shall not include proceeds attributed in such sublicense or such agreement, arrangement or other relationship to bona fide (i) debt financing; (ii) equity (and conditional equity, such as warrants, convertible debt and the like) investments in the Licensee or any Affiliate up to [*] of the fair market value; (iii) reimbursements of Patent Prosecution Costs actually incurred by the Licensee; and (iv) research and/or development fees received by or payable to Licensee from Sublicensee as reimbursement or advance payment for bona fide costs of ongoing and/or future research and/or development services or activities to be undertaken by Licensee under such sublicense directly related to this Agreement, and provided at or below applicable industry standard rates for such services or activities within the same industry. For the avoidance of doubt, any gross proceeds meeting the definition set forth above in this Paragraph 1.2 shall be “Attributed Income” irrespective of whether such gross proceeds are received under one or more separate agreements and irrespective of how such gross proceeds are referred to or characterized by the Licensee or the Sublicensee; provided that any amounts received by the Licensee in consideration for both the grant of a sublicense under the Patent Rights and a license under other patents or know-how owned or controlled by the Licensee (including any patents licensed under the T3 License Agreement) shall be allocated by mutual agreement between The Regents and the Licensee, such agreement not to be unreasonably withheld, among the Patent Rights and all other such patents and know-how licensed, and only the portion allocated to the Patent Rights shall be Attributed Income under this Agreement.

1.3 “Diagnostic Licensed Product” means a Licensed Product that is used for diagnostic and/or prognostic applications.

1.4 “Earned Royalty” means the Royalty (as defined in Paragraph 8.1).

1.5 “Field of Use” means all fields and all uses.

1.6 “Indexed Milestone Payment” is defined in Paragraph 5.2.

1.7 “Joint Venture” means any entity which, directly or indirectly, owns or is owned by Licensee, but at an ownership level below that set forth in the definition of Affiliate under Section 1.1, which entity has been granted a sublicense to manufacture, use, purchase, Sell or acquire Licensed Products from the Licensee.

4

1.8 “Licensed Method” means any process, art or method the use or practice of which, but for the license granted in this Agreement, would infringe any Patent Rights in any country were they issued at the time of the infringing activity in that country.

1.9 “Licensed Product(s)” means any Product, including, without limitation, a Product for use or used in practicing a Licensed Method and any Product made by practicing a Licensed Method, the manufacture, use, Sale, offer for Sale or import of which, but for the license granted in this Agreement, would infringe any Patent Rights in any country were they issued at the time of the infringing activity in that country.

1.10 “Licensed Service” means any service provided for consideration (whether in cash or any other form of consideration to which a fair market value can be assigned), when such service (i) involves the use of a Licensed Product; or (ii) involves the practice of a Licensed Method.

1.11 “Net Invoice Price” means the gross invoice price charged by (or, where no such price is charged, the value of any other consideration owed to) the Licensee or any Sublicensee for a Licensed Product, Licensed Method or Licensed Service, less the following items, but only to the extent that they actually pertain to the disposition of such Licensed Product or Licensed Service, are included in the gross invoice price charged or other form of consideration owed to which a fair market value can be assigned, and are identified separately on a bill or invoice:

 	1.11.1

Allowances actually granted to customers for rejections, returns and prompt payment and volume discounts;

 	1.11.2	
Freight, transport packing and insurance charges associated with transportation;

 	1.11.3	
Taxes, including Deductible Value Added Tax, tariffs or import/export duties based on Sales when included in the gross invoice price, but excluding value-added taxes other than Deductible Value Added Tax or taxes assessed on income derived from Sales. “Deductible Value Added Tax” means only the portion of the value added tax that is actually incurred and is not reimbursable, refundable or creditable under the tax authority of any country;

 	1.11.4

Normal and customary discounts and rebates given as a part of a formulary program that are paid or credited to customers, third-party payers, healthcare systems, or administrators for a Licensed Product or Licensed Service that is included in such formulary program, as permitted by applicable law;

5

 	1.11.5	
Normal and customary wholesaler’s discounts and rebates given as a part of a formulary program that are paid or credited to customers, third-party payers, health care systems, or administrators for a Licensed Product or Licensed Service that is included in such formulary program, as permitted by applicable law; and

 	1.11.6

Rebates and discounts paid or credited pursuant to applicable law.

In those instances where the Licensed Product, Licensed Method or Licensed Service is combined in any manner with any other Product or service, Net Sales shall be calculated as:

A/(A+B) x [Net Sales, calculated without regard to this formula, of the combination], where “A” is the average invoice price in the country of sale of the Licensed Product, Licensed Method or Licensed Service when Sold separately, and “B” is the average invoice price in the country of sale of each other Product or service contained within or used in the combination when Sold separately. If either the Licensed Product, Licensed Method or License Service or other Product or service is not sold separately, then Net Sales for such Sale shall be calculated by multiplying the Net Sales of the combination, calculated without regard to this formula, by a fraction that represents the market value that the Licensed Product contributes to the total value of the combination, as determined by the parties in good faith.

1.12 “Net Sale” means:

 	1.12.1

except in the instances described in Paragraphs 1.12.2, 1.12.3 and 1.12.4, the Net Invoice Price;

 	1.12.2	
for any Relationship-Influenced Sale of a Licensed Product or Licensed Service, Net Sales shall be based on the highest of either (i) the Net Invoice Price at which the Relationship-Influenced Sale Purchaser re-Sells such Licensed Product or Licensed Service or (ii) the Net Invoice Price paid for the Licensed Product or Licensed Service by the Relationship-Influenced Sale Purchaser;

6

 	1.12.3

in those instances where Licensed Product or Licensed Service is not Sold, but is otherwise exploited, the Net Sales for such Licensed Product or Licensed Service shall be the Net Invoice Price of such Licensed Product or Licensed Service currently being offered for Sale by the Licensee or any Sublicensee. Where such Licensed Product or Licensed Service is not currently Sold or offered for Sale by the Licensee or any Sublicensee, the Net Sales for Licensed Product or Licensed Service otherwise exploited, for the purpose of computing royalties, shall be the average Net Invoice Price at which products or services of the same or similar kind and quality, Sold in similar quantities, are then currently being offered for Sale by other manufacturers. Where such products or services are not currently Sold or offered for Sale by the Licensee or any Sublicensee, or others, then the Net Sales shall be the Licensee’s or any Sublicensee’s cost of manufacture of Licensed Product or the cost of conducting the Licensed Service, determined according to Generally Accepted Accounting Principles (“GAAP”), [*]; and

1.12.4	
for a Re-Sale or Exploitation, Net Sales shall mean the Net Invoice Price upon the Re-Sale or Exploitation of a Licensed Product or Licensed Service.

Net Sales shall not include any amount for the disposition of Licensed Product in reasonable quantities for (a) conducting clinical trials to obtain regulatory approval to commercialize such Licensed Product, (b) samples (promotional or otherwise), or (c) donations (for example, to non-profit institutions or government agencies for a non-commercial purpose) or patient assistance or compassionate use programs.

1.13 “New Developments” means inventions, or claims to inventions, owned or otherwise controlled by The Regents which constitute advancements, developments or improvements, whether or not patentable and whether or not the subject of any patent application, which are not sufficiently supported by the specification of a previously-filed patent or patent application within the Patent Rights to be entitled to the priority date of the previously-filed patent or patent application.

1.14 “Patent Prosecution Costs” is defined in Paragraph 20.4.

7

1.15 “Patent Rights” means the Valid Claims of, to the extent assigned to or otherwise obtained by The Regents, the following United States patents and patent applications:

UC Case Number	  	United States Patent or
Application Number	 	Filing or Issue Date
SF2003-057-1

  	[*]	 	[*]
SF2003-057-2

  	[*]	 	[*]
SF2003-057-3

  	[*]	 	[*]
SF2003-057-4

  	[*]	 	[*]
SF2003-057-5

  	[*]	 	[*]
SF2009-119-1

  	[*]	 	[*]
SF2009-119-2

  	[*]	 	[*]

Patent Rights shall further include the Valid Claims of, to the extent assigned to or otherwise obtained by The Regents, the corresponding foreign patents and patent applications (requested under Paragraph 20.5 herein) and any reissues, certificates of reexamination, extensions, substitutions, continuations, divisions, and continuation-in-part applications (but only those Valid Claims in the continuation-in-part applications that are entirely supported in the specification and entitled to the priority date of the parent application). This definition of Patent Rights excludes any rights in and to New Developments.

1.16 “Product” means any kit, article of manufacture, composition of matter, material, compound, component or product.

1.17 “Re-Sale or Exploitation” means those instances where a Sublicensee acquires a Licensed Product or Licensed Service (from the Licensee or another Sublicensee) and then subsequently Sells or otherwise exploits such Licensed Product or Licensed Service.

1.18 “Related Party” means a corporation, firm or other entity with which, or individual with whom, the Licensee or any Sublicensee (or any of its respective stockholders, subsidiaries or Affiliates) have any agreement, understanding or arrangement (for example, but not by way of limitation, an option to purchase stock or other equity interest, or an arrangement involving a division of revenue, profits, discounts, rebates or allowances) without which such other agreement, understanding or arrangement, the amounts, if any, charged by the Licensee or any Sublicensee to such entity or individual for the Licensed Product or Licensed Service, would be higher than the Net Invoice Price actually received, or if such agreement, understanding or arrangement results in the Licensee or any Sublicensee extending to such entity or individual lower prices for such Licensed Product or Licensed Service than those charged to others without such agreement, understanding or arrangement buying similar products or services in similar quantities.

8

1.19 “Relationship-Influenced Sale” means a Sale of a Licensed Product or Licensed Service, or any exploitation of the Licensed Product or Licensed Method, between the Licensee or any Sublicensee and (i) an Affiliate; (ii) a Joint Venture; (iii) a Related Party or (iv) the Licensee, or a Sublicensee.

1.20 “Relationship-Influenced Sale Purchaser” means the purchaser of Licensed Product or Licensed Service in a Relationship-Influenced Sale.

1.21 “Sale” means the act of selling, leasing or otherwise transferring, providing, or furnishing for use for any consideration to which a fair market value can be assigned. Correspondingly, “Sell” means to make or cause to be made a Sale and “Sold” means to have made or caused to be made a Sale.

1.22 “Service Income” means Net Sales with respect to Licensed Services. Service Income shall not include, and is excluded from, Attributed Income.

1.23 “Sublicensee” means any person or entity (including any Affiliate or Joint Venture) to which any of the license rights granted to the Licensee hereunder are sublicensed.

1.24 “Sublicense Fee” is defined in Paragraph 7.1.

1.25 “T2 Licensed Products” means all Licensed Products under this Agreement that do not meet the definition of Licensed Products (as defined in the T3 License Agreement) under the T3 License Agreement.

1.26 “T2/T3 Licensed Products” means all Licensed Products under this Agreement that also meet the definition of Licensed Products (as defined in the T3 License Agreement) under the T3 License Agreement.

1.27 “T3 Licensed Products” means all products that meet the definition of Licensed Products (as defined in the T3 License Agreement) under the T3 License Agreement, but that do not meet the definition of Licensed Products under this Agreement.

1.28 “Therapeutic Licensed Product” means a Licensed Product that is used to prevent, treat or cure one or more diseases and/or conditions.

1.29 “Third Party Compound” means any Licensed Product consisting of a compound identified and developed either by the Licensee, or by a third party and provided by such third party to Licensee for further development by Licensee, containing electrophile group platform technology covered by the Patent Rights licensed to Licensee under this Agreement. For avoidance of doubt, any compounds identified and developed by Dr. Jack Taunton or the other Inventors at UCSF will not be considered “Third Party Compounds.”

9

1.30 “Valid Claim” means a claim of a patent or patent application in any country that (i) has not expired; (ii) has not been disclaimed; (iii) has not been cancelled or superseded or, if cancelled or superseded, has been reinstated; and (iv) has not been revoked, held invalid, or otherwise declared unenforceable or not allowable by a tribunal or patent authority of competent jurisdiction over such claim in such country from which no further appeal has or may be taken.

2.	
GRANT

2.1 Subject to the limitations and other terms and conditions set forth in this Agreement including the license granted to the United States Government and those reserved by HHMI set forth in the Background and in Paragraph 2.3.1, The Regents grants to the Licensee a license under its rights in and to Patent Rights to make, use, Sell, offer for Sale and import Licensed Products and Licensed Services and to practice Licensed Methods, in the United States and in other countries where The Regents may lawfully grant such licenses, only in the Field of Use.

2.2 Except as provided in Paragraphs 2.3.1, 2.3.2 and 2.3.3 of this Agreement, the license granted under Patent Rights in Paragraph 2.1 is exclusive.

2.3 The license granted in Paragraphs 2.1 is subject to the following:

 	2.3.1

The obligations to the United States Government under 35 U.S.C. §§ 200-212 and all applicable governmental implementing regulations, as amended from time to time, including the obligation to report on the utilization of the Invention as set forth in 37 CFR. § 401.14(h), and all applicable provisions of any license to the United States Government executed by The Regents; and

 	2.3.2	
the paid-up, non-exclusive, irrevocable licenses reserved by HHMI to make and use the Invention for its research purposes. Such licenses reserved by HHMI specified in the recitals and the immediately prior sentence do not include the right to sublicense others; and

10

 	2.3.3

the National Institutes of Health “Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources,” 64 F.R. 72090 (Dec. 23, 1999), as amended from time to time) and HHMI’s statement of policy on research tools. Note: HHMI’s policy can be found at http://www.hhmi.org/about/research/policies.html#sharing

2.4 The Regents reserves and retains the right (and the rights granted to the Licensee in this Agreement shall be limited accordingly) to make, use and practice the Invention, and any technology owned by The Regents relating to the Invention and to make and use any Products and to practice any process that is the subject of the Patent Rights (and to grant any of the foregoing rights to other educational and non-profit institutions) for educational and research purposes, including without limitation, any sponsored research performed for or on behalf of commercial entities, and including publication and other communication of any research results. The Regents agrees to inform any commercial entities seeking the use of any such Patent Rights of the existence of this Agreement. Any transfer of tangible materials covered by the Patent Rights shall be pursuant to a materials transfer agreement similar in form and substance to Appendix B. The Licensee may request a list of institutions which received any such materials every six months. For the avoidance of doubt, to the extent the Invention, any biological materials and any technology relating to any of the foregoing are not the subject of the exclusive license under the Patent Rights granted to the Licensee hereunder, The Regents shall be free to make, use, Sell, offer to Sell, import, practice and otherwise commercialize and exploit (including to transfer, license to, or have exercised by, third parties) for any purpose whatsoever and in its sole discretion, such Invention, technology and any Products or processes that are the subject of any of the foregoing.

2.5 Because the Invention was made under funding provided by the United States Government, Licensed Products, the Invention, and any products embodying the Invention sold in the United States will be substantially manufactured in the United States, unless the Licensee obtains a waiver of such requirement from the NIH under 35 U.S.C. § 204.

11

3.	
SUBLICENSES

3.1 The Regents also grants to the Licensee the right to sublicense to third parties (including to Affiliates and Joint Ventures) the rights granted to the Licensee hereunder, with the right to further sublicense as provided below, as long as the Licensee has current exclusive rights thereto under this Agreement. Each Sublicensee must be subject to a written sublicense agreement. Each and every sublicense will include all of the rights of, and will require the performance of all the obligations due to, The Regents and HHMI (and, if applicable, the United States Government and other sponsors), other than those rights and obligations specified in Article 5 (License Issue Fee), Article 6 (License Maintenance Fee) and Paragraph 8.2 (Minimum Annual Royalty) and Paragraphs 20.4 and 20.6 (reimbursement of Patent Prosecution Costs). Licensee may grant its Sublicensee the further right to grant sublicense rights under any of the rights granted by The Regents to Licensee hereunder but only to the extent needed for the research, development (including for the purposes of conducting pre-clinical and clinical trials, and seeking regulatory approval for commercialization), manufacture and/or commercialization of Licensed Product and/or Licensed Methods; provided that each and any such further Sublicensees shall be bound by the terms of this Agreement. For the avoidance of doubt, Affiliates and Joint Ventures shall have no licenses under this Agreement unless such Affiliates and Joint Ventures are granted a sublicense, and the Licensee will not enter into any research or development arrangements for Licensed Products or Licensed Services with any third party without granting it a sublicense, if a sublicense is required to conduct the applicable activities. For the purposes of this Agreement, the operations of all Sublicensees with respect to the exploitation of the Patent Rights shall be deemed to be the operations of the Licensee, for which the Licensee shall be responsible.

3.2 In the event that The Regents and the Licensee each own an undivided interest in any Patent Rights licensed hereunder, the Licensee will not separately grant a license to any third party under its rights without concurrently granting a license under The Regents’ rights on the terms and conditions described in this Article 3 (Sublicenses).

3.3 The Licensee will notify The Regents of each sublicense granted hereunder and will provide The Regents with a complete copy of each sublicense, which may be redacted of any terms not necessary for The Regents to confirm compliance with the terms of this Agreement or Sublicense Fees paid by the Licensee (along with a summary of the material terms

12

of each such sublicense) and each amendment to such sublicense within thirty (30) days of issuance of such sublicense or such amendment. The Licensee will collect from Sublicensees and pay to The Regents all fees, payments, royalties and the cash equivalent of any consideration due The Regents under the terms of this Agreement. The Licensee will guarantee all monies due The Regents from Sublicensees under the terms of this Agreement. For clarity, if the Licensee grants a sublicense that contains a provision for payment of royalties by any Sublicensee in an amount that is less than the Royalty required to be paid under Paragraph 8.1 below, then the Licensee will pay to The Regents a total amount equal to the Royalty based on the Sublicensees’ Net Sales as provided for in Paragraph 8.1. The Licensee will require Sublicensees to provide it with copies of all progress reports and royalty reports in accordance with the provisions herein and the Licensee will collect and deliver all such reports due The Regents from Sublicensees under the terms of this Agreement.

3.4 If Licensee licenses patent rights assigned to or otherwise acquired by it (“Licensee’s Patent Rights”), and it believes, in good faith, that the recipient of such license will infringe Patent Rights in practicing the Licensee’s Patent Rights, then the Licensee will not separately grant a license to such recipient under Licensee’s Patent Rights without concurrently granting a sublicense under Patent Rights on the terms required under this Agreement.

3.5 Upon any termination of this Agreement for any reason, all sublicenses granted by Licensee shall survive termination as direct licenses from The Regents to the Sublicensees; provided that The Regents will not be bound by any grant of rights broader than, and will not be required to perform any obligation other than, those rights and obligations contained in this Agreement; and provided further, that at such time such Sublicensee is not in breach of any of its obligations under the sublicense granted to it by Licensee. Moreover, The Regents will have the sole right to modify each such surviving license to include all of the rights of The Regents (and, if applicable, the United States Government and other sponsors) that are contained in this Agreement, including the payment of Earned Royalties, and Minimum Annual Royalties, directly to The Regents by the Sublicensee as if it were the Licensee at the rate with respect to Earned Royalties, and the amount with respect to Minimum Annual Royalties, set forth in this Agreement, with the Minimum Annual Royalties allocated proportionately among Sublicensees, if more than one.

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4.	
PAYMENT TERMS

4.1 Paragraphs 1.8, 1.9, 1.10 and 1.15 define Licensed Method, Licensed Product, Licensed Service and Patent Rights, so that Earned Royalties are payable on products and methods covered by both pending patent applications and issued patents. Earned Royalties will accrue in each country for the duration of Patent Rights in that country and will be payable to The Regents when Licensed Products or Licensed Services are invoiced, or if not invoiced, when delivered or otherwise exploited by the Licensee or Sublicensee in a manner constituting a Net Sale as defined in Paragraph 1.12. Sublicense Fees with respect to any Attributed Income shall accrue to The Regents [*]. If Licensee is unable for any reason to make such payment, the parties agree to discuss the matter in good faith to arrange for payment under terms reasonably acceptable to The Regents before the provisions of Article 14 (Termination by The Regents) of the Agreement will apply.

4.2 The Licensee will pay to The Regents all License Maintenance Fees pursuant to Paragraph 6, Sublicense Fees pursuant to Paragraph 7, Earned Royalties and Minimum Annual Royalties pursuant to Paragraph 8, and Milestone Payments pursuant to Paragraph 9 payable to The Regents [*]. Each payment for License Maintenance Fees, Sublicense Fees, Earned Royalties and Minimum Annual Royalties, Sublicense Fees and Milestone Payments will be for amounts which have accrued [*].

4.3 All consideration due The Regents will be payable and will be made in United States dollars by check payable to “The Regents of the University of California” or by wire transfer to an account designated by The Regents. The Licensee is responsible for all bank or other transfer charges. When Licensed Products or Licensed Services are Sold for monies other than United States dollars, the Earned Royalties and other consideration will first be determined in the currency of the country in which such Licensed Products or Licensed Services were Sold and then converted into equivalent United States dollars. The exchange rate used with respect to any foreign currency will be the average exchange rate quoted in The Wall Street Journal for the purchase of United States dollars during the last thirty (30) days of the reporting period.

4.4 Sublicense Fees and Earned Royalties accrued in any country outside the United States may be reduced by any taxes, fees or other charges imposed by the government of such country (“withholding taxes”), except as and to the extent the Licensee is able to avail itself of a tax credit for such withholding taxes in the year in which such amounts were paid.

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4.5 Notwithstanding the provisions of Article 27 (Force Majeure) if at any time legal restrictions prevent the prompt remittance of Earned Royalties or other consideration owed to The Regents by the Licensee with respect to any country where a sublicense is granted or a Licensed Product or Licensed Service is Sold or otherwise exploited, then the Licensee shall convert the amount owed to The Regents into United States dollars as described in Paragraph 4.3, and will pay The Regents directly from another source of funds in order to remit the entire amount owed to The Regents.

4.6 In the event that any patent or claim thereof included within the Patent Rights is held invalid in a final decision by a court of competent jurisdiction and last resort and from which no appeal has or can be taken, then all obligation to pay royalties based on that patent or claim or any claim patentably indistinct therefrom will cease as of the date of final decision. The Licensee will not, however, be relieved from paying any Earned Royalties or Minimum Annual Royalties that accrued before such final decision and the Licensee shall be obligated to pay the full amount of such Earned Royalties or Minimum Annual Royalties due hereunder to the extent that the Licensee is licensed by The Regents under one or more Valid Claims within the Patent Rights with respect to Licensed Products or Licensed Services.

4.7 No Earned Royalties will be collected or paid hereunder to The Regents on Licensed Products or Licensed Services Sold to, or otherwise exploited for, the account of the United States Government as provided for in the license to the United States Government. The Licensee and its Sublicensees will reduce the amount charged for Licensed Products or Licensed Services Sold to, or otherwise exploited for, the United States Government by an amount equal to the Earned Royalty for such Licensed Products or Licensed Services that otherwise would have been due The Regents. Such reduction in Earned Royalties will be in addition to any other reductions in price required by the United States Government.

4.8 In the event that License Maintenance Fees, Sublicense Fees, Earned Royalties and Minimum Annual Royalties, Sublicense Fees and Milestone Payments, or reimbursements for Patent Prosecution Costs, owed to The Regents are not received by The Regents when due, the Licensee will pay to The Regents interest at a rate of [*] simple interest per annum. Such interest will be calculated from the date payment was due until such payment was actually received by The Regents. Such accrual of interest will be in addition to and not in lieu of, enforcement of any other rights of The Regents due to such late payment.

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5.	
LICENSE ISSUE FEE

5.1 The Licensee will pay to The Regents a license issue fee of thirty thousand dollars ($30,000) within [*]. This fee is non-refundable, non-cancelable and is not an advance or otherwise creditable against any royalties or other payments required to be paid under the terms of this Agreement. The Regents acknowledges and agrees that as of the Amendment Effective Date, the license issue fee has been paid by the applicable due date, and the Licensee has no outstanding obligations or liabilities under this Section 5.1 as of such date.

5.2 In addition, within [*] of either (i) closing of the initial public offering of the common stock of the Licensee pursuant to a registration statement filed with the Securities and Exchange Commission (“IPO”) or (ii) closing of a Liquidation Event, as defined in Licensee’s certificate of incorporation (as amended from time to time), Licensee, subject to the terms of Paragraph 5.3, shall make to The Regents a cash payment equal to 50,000 times $P, where $P is either the IPO price per share of common stock or in the case of a merger or acquisition Liquidation Event, the average price per share paid for all common stock acquired by the merged or acquiring company (“Indexed Milestone Payment”). For clarity, the Regents shall receive the payment that the holder of 50,000 shares of common stock would receive in such merger or acquisition upon the closing of such merger or acquisition (but excluding any amounts withheld in escrow until such time as such escrow is released). The obligation of the Licensee to make this Indexed Milestone Payment shall be a one-time payment obligation and will survive termination or expiration of this Agreement and, in the case of payment as a result of provision (ii) of this Section 5.2, such payment shall be subordinate to the liquidation preferences of any Preferred Stock of Licensee as set forth in Licensee’s then current Certificate of Incorporation.

5.3 After the Effective Date, if the outstanding shares of common stock of Licensee shall be subdivided (by stock split, stock dividend or otherwise) into a greater number of shares of common stock, the number specified above (initially 50,000) in effect immediately prior to such subdivision shall, concurrently with the effectiveness of such subdivision, be proportionately increased. After the Effective Date, if the outstanding shares of common stock shall be combined (by reclassification or otherwise) into a lesser number of shares of common stock, the number specified above (initially 50,000) in effect immediately prior to such combination shall, concurrently with the effectiveness of such combination, be proportionately decreased.

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6.	
LICENSE MAINTENANCE FEE

The Licensee will also pay to The Regents a license maintenance fee of thirty thousand dollars ($30,000) beginning on the two-year anniversary of the Effective Date and continuing annually on each anniversary of the Effective Date. The license maintenance fee is not due on any anniversary of the Effective Date if, on that date, the Licensee is Selling or otherwise exploiting Licensed Products or Licensed Services and is paying an Earned Royalty to The Regents on the Net Sales of such Licensed Product or Licensed Services. The license maintenance fee is non-refundable and is not an advance or otherwise creditable against any royalties or other payments required to be paid under the terms of this Agreement.

7.	
PAYMENTS ON SUBLICENSES

7.1 The Licensee will pay to The Regents the following non-refundable and non-creditable sublicense fees (“Sublicense Fees”):

 	7.1.1

With respect to Attributed Income from any Sublicense of Patent Rights, other than [*]:

 	7.1.1.1	
[*]of all such Attributed Income for any Sublicense granted [*];

 	7.1.1.2	
[*] of all such Attributed Income for any Sublicense granted [*];

 	7.1.1.3	

 	7.1.1.4	
[*] of all such Attributed Income for any Sublicense granted [*]; or

 	7.1.1.5	
[*] of all such Attributed Income for any Sublicense granted [*].

 	7.1.2	
With respect to Attributed Income from a Sublicense of Patent Rights with regards [*]:

 	7.1.2.1	
[*].

8.	
EARNED ROYALTIES AND MINIMUM ANNUAL ROYALTIES

8.1 The Licensee will also pay to The Regents the following earned royalty, with respect to cumulative Net Sales by the Licensee, Affiliates, Joint Ventures and Sublicensees, in a given calendar year (collectively, the “Royalty”):

(i) [*] of cumulative annual Net Sales of Licensed Product (other than Third Party Compounds) up to and including [*]; and

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(ii) [*] of cumulative annual Net Sales of Third Party Compounds up to and including [*]; and

(iii) [*] of any amount of annual Net Sales of Licensed Product (other than Third Party Compounds) in excess of [*]; and

(iv) [*] of any amount of annual Net Sales of Third Party Compounds in excess of [*].

8.2 The Licensee will also pay to The Regents a minimum annual royalty of fifty thousand dollars ($50,000) for the life of Patent Rights, beginning with the year of the first Sale of Licensed Product, Licensed Service or Licensed Method. The minimum annual royalty will be paid to The Regents by [*] of each year and will be credited against the Earned Royalty due for the calendar year in which the minimum payment was made. Licensee’s obligation to pay the minimum annual royalty will be pro-rated for the number of months remaining in the calendar year when Sales commence and, in the event that such pro-rated minimum annual royalty amount exceeds Earned Royalties paid to The Regents in the remainder of the calendar year in which the first Sale of Licensed Product, Licensed Service or Licensed Method was made, the difference between the pro-rated minimum annual royalty for the first calendar year and the sum of the amount of Earned Royalties paid and to be paid to The Regents in such first year will be due the following [*] (along with the minimum annual royalty payment for the second calendar year).

8.3 Notwithstanding Paragraph 8.1, if Licensee finds it necessary or desirable to obtain a license under a patent of one or more third parties to make, sell, offer for sale or import a Licensed Product, and if the combined royalty due to UCSF and these unaffiliated third party(ies) exceeds [*], then the royalty to be paid to UCSF by Licensee shall be reduced by the amount determined by the following formula: [*], in which [*]. However, in no event shall the amount paid to UCSF be reduced below [*] of the original royalty amounts due UCSF. Furthermore, at the time that the first royalty payment reduction described in this Paragraph 8.3 with respect to any Licensed Product occurs, Licensee shall pay to The Regents a one-time, non-refundable, non-creditable payment of [*].

8.4 With respect to each Licensed Product, if Licensee is obligated to make royalty payments to The Regents under this Agreement and under the T3 Licensed Agreement on the Net Sales of such Licensed Product, then Licensee shall make royalty payments under this Agreement, and shall have no obligation to pay and The Regents shall have no right to receive royalties under the T3 License Agreement on the Net Sales of such Licensed Product.

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9.	
MILESTONE PAYMENTS

9.1 With respect to a Therapeutic Licensed Product that is not a Third Party Compound, the Licensee will pay to The Regents the following non-refundable, non-creditable amounts on a one-time basis, for the first such event to occur:

 	9.1.1	
[*] upon [*];

 	9.1.2	

 	9.1.3	

 	9.1.4	

 	9.1.5	
[*] upon [*]; and

 	9.1.6	
[*] upon [*].

9.2 With respect to a Diagnostic Licensed Product, the Licensee will pay to The Regents the non-refundable, non-creditable fee in amount of [*] upon [*].

9.3 For the avoidance of doubt, each of the milestone payments set forth in Paragraphs 9.1.1 through 9.1.6 and in Paragraph 9.2 will be payable only once with respect to only the first Licensed Product to achieve such milestone, regardless of whether the applicable milestone event has been achieved by the Licensee or any Affiliate, Joint Venture or Sublicensee.

9.4 All milestone payments due hereunder are due to The Regents within [*] after the occurrence of the applicable milestone event.

10.	
DUE DILIGENCE

10.1 The Licensee will secure financing in the amount of at least [*] by [*] (“Financing Period”). In the event the Licensee is unable to attain financing within the Financing Period, The Regents, in its sole discretion, will have the option of extending the Financing Period by an additional [*] prior to triggering the provisions of Paragraph 10.5 and 10.7 below, provided the Licensee can demonstrate its diligent efforts (with reasonable supporting documentation) to meet the above milestone. As of the Amendment Effective Date, The Regents acknowledges and agrees that the Licensee has secured such financing and that the Financing Period was extended pursuant to this Section 10.1 such that the provisions of Paragraphs 10.5 and 10.7 were not triggered.

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10.2 The Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture and, if successful, seeking of regulatory approval and Sale of Licensed Products and Licensed Services and will earnestly and diligently market the same after execution of this Agreement and in quantities sufficient to meet the market demands therefor.

10.3 The Licensee will obtain all necessary governmental approvals in each country where Licensed Products and Licensed Services are manufactured, used, Sold, offered for Sale or imported.

10.4 The Licensee will:

 	10.4.1	
[*] within [*];

 	10.4.2	

 	10.4.3

 	10.4.4	

 	10.4.5	
[*] within [*]; and

 	10.4.6	
fill the market demand for Licensed Products and Licensed Services following commencement of marketing at any time during the exclusive period of this Agreement.

10.5 If the Licensee does not satisfy its obligations under any of the provisions of this Article 10, then The Regents has the right and option to either terminate this Agreement or reduce the exclusive license granted to the Licensee to a nonexclusive license in accordance with Paragraph 10.6 below. This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Grant).

10.6 The Regents recognizes that there are uncertainties associated with the development of therapeutic products and the regulatory process required by the FDA (and foreign regulatory authorities that are equivalent to the FDA), and that it may be necessary from time to time to amend the milestones under Subparagraphs 10.4.1 through 10.4.6. Accordingly, The Regents agrees to extend each such milestone under Subparagraphs 10.4.1 through 10.4.6 for up to one (1) year provided that Licensee can demonstrate to The Regents its diligent efforts with supporting documentation, at no cost to the Licensee for the first extension. Additional one (1) year extensions are available for any milestone provided that Licensee can continue to

20

demonstrate its diligent efforts with supporting documentation and pays an additional extension fee of [*]. An extension will extend all remaining milestones in Subparagraphs 10.4.1 through 10.4.6 by the applicable time period. Notwithstanding the foregoing, in the event that unforeseen circumstances warrant amendment of Licensee’s development plan, and Licensee can demonstrate its diligent efforts (with reasonable supporting documentation) to meet the milestones above to The Regents’ satisfaction (based solely on the Regents’ assessment of Licensee’s demonstration and supporting documentation), Licensee and The Regents will agree to negotiate in good faith a revision to the foregoing milestones.

10.7 To exercise either the right to terminate this Agreement or to reduce the exclusive license granted to the Licensee to a non-exclusive license for failure to satisfy its obligations under any of the paragraphs of this Article 10 (Due Diligence), The Regents will give the Licensee written notice of the deficiency. The Licensee thereafter has [*] to cure the deficiency. If The Regents has not received written tangible evidence satisfactory to The Regents that the deficiency has been cured (or that a plan to cure has been established where such deficiency is not susceptible to cure within such [*] period) by the end of the [*] period, then The Regents may, at its option, terminate this Agreement immediately without the obligation to provide [*] notice as set forth in Article 14 (Termination by The Regents) or reduce the exclusive license granted to the Licensee to a non-exclusive license by giving written notice to the Licensee.

11.	
PROGRESS AND ROYALTY REPORTS

11.1 Beginning on [*], and [*] thereafter, the Licensee will submit to The Regents a written progress report as described in Paragraph 11.2 below covering the Licensee’s (and any Affiliates’, Joint Ventures’ or Sublicensee’s) activities related to the development and testing of all Licensed Products and Licensed Services and related to the obtaining of the governmental approvals necessary for marketing and the activities required and undertaken in order to meet the diligence requirements set forth in Article 10 (Due Diligence). Progress reports are required for each Licensed Product and Licensed Service until the first Sale or other exploitation of a Licensed Product or Licensed Service occurs in the United States and shall be again required if Sales of such Licensed Product or Licensed Service are suspended or discontinued.

11.2 Progress reports submitted under Paragraph 11.1 shall include, but are not limited to, a detailed summary of the following topics so that The Regents will be able to determine the progress of the development of Licensed Products and Licensed Services and will also be able to determine whether or not the Licensee has met its diligence obligations set forth in Article 10 (Due Diligence) above:

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 	11.2.1	
a summary of efforts to get funding;

 	11.2.2	
a summary of work completed as of the submission date of the progress report;

 	11.2.3	
key scientific discoveries under Patent Rights as of the submission date of the progress report;

11.2.4	
a summary of work in progress under Patent Rights as of the submission date of the progress report;

 	11.2.5	
current schedule of anticipated events and milestones under Patent Rights, including those event and milestones specified in Article 10 (Due Diligence);

 	11.2.6	
commencing [*] before the anticipated date of receiving FDA approval of a first Licensed Product or a first Licensed Service, a summary of market plans for introduction of Licensed Products and Licensed Services including the anticipated and actual market introduction dates of each Licensed Product or Licensed Service;

 	11.2.7	
a summary Sublicensees’ activities relating to the above items, if there are any Sublicensees; and

 	11.2.8	
a summary of resources (dollar value) spent in the reporting period.

11.3 If the Licensee fails to submit a timely progress report to The Regents, then The Regents will be entitled to terminate this Agreement. If either party terminates this Agreement before any Licensed Products or Licensed Services are Sold or before this Agreement’s expiration, then a final progress report covering the period prior to termination must be submitted within [*] of termination or expiration.

11.4 The Licensee has a continuing responsibility to keep The Regents informed of the business entity status (small business entity status or large business entity status as defined by the United States Patent and Trademark Office) of itself, any Affiliates, Joint Ventures, or Sublicensees. The Licensee will notify The Regents of any change of its status or that of any Affiliate, Joint Venture, or Sublicensee within [*] of the change in status.

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11.5 The Licensee will report to The Regents the date of first Sale or other exploitation of a Licensed Product or Licensed Service in each country in its first progress and royalty reports following such first Sale of a Licensed Product or Licensed Service.

11.6 Beginning with the earlier of (i) the first Sale or other exploitation of a Licensed Product or Licensed Service or (ii) the first transaction that results in Sublicense Fees accruing to The Regents, the Licensee will make [*] Earned Royalty and Sublicensee Fee reports to The Regents on or before [*] of each year. Each Earned Royalty and Sublicensee Fee report will cover Licensee’s most recently completed calendar quarters and will, at a minimum, show:

 	11.6.1	
the gross invoice prices and Net Sales of Licensed Products or Licensed Services Sold or otherwise exploited (itemizing the applicable gross proceeds and any deductions therefrom), any Attributed Income (itemizing the applicable gross proceeds and any deductions therefrom) and any Service Income (itemizing the applicable gross proceeds and any deductions therefrom) due to the Licensee;

 	11.6.2

the quantity of each type of Licensed Product and/or Licensed Service Sold or otherwise exploited;

 	11.6.3	
the country in which each Licensed Product and Licensed Service was made, used or Sold or otherwise exploited;

 	11.6.4	
the Earned Royalties, in United States dollars, payable with respect to Net Sales and Service Income after, in each year, credit for the minimum annual royalty paid to The Regents for such year pursuant to Paragraph 8.2;

 	11.6.5	
the Sublicense Fees, in United States dollars, payable with respect to Attributed Income;

 	11.6.6	
the method used to calculate the Earned Royalty, specifying all deductions taken and the dollar amount of each such deduction;

 	11.6.7	
the exchange rates used, if applicable;

 	11.6.8

the amount of the cash equivalent of any non-cash consideration including the method used to calculate the non-cash consideration; and

 	11.6.9	
for each Licensed Product and each Licensed Service, the specific Patent Rights identified by UC Case Number exercised by the Licensee or any Affiliate, Joint Venture or Sublicensee in the course of making, using, selling, offering for Sale or importing such Licensed Product and/or using, selling or offering for Sale such Licensed Service.

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11.7 If no Sales of Licensed Products and Licensed Services have been made and no Licensed Products and Licensed Services have been otherwise exploited and no Attributed Income is due to the Licensee during any reporting period, then a statement to this effect must be provided by the Licensee in the immediately subsequent Earned Royalty and Sublicense Fee report.

12.	
BOOKS AND RECORDS

12.1 The Licensee will keep, and will use reasonable commercial efforts to cause Affiliates, Joint Ventures and Sublicensees to keep, accurate books and records showing all Licensed Product under development, manufactured, used, offered for Sale, imported, Sold and or otherwise exploited; all Licensed Service Sold or otherwise provided; all Net Sales, all Attributed Income, all Service Income and other amounts to be paid to The Regents hereunder; and all sublicenses granted under the terms of this Agreement. Such books and records will be preserved for at least [*] after the date of the payment to which they pertain and will be open to examination by representatives or agents of The Regents during regular office hours after not less than [*] prior written notice, and not more frequently than once during any calendar year, to determine their accuracy and assess the Licensee’s compliance with the terms of this Agreement.

12.2 The Regents shall pay the fees and expenses of such examination. If, however, an error of more than [*] of the Earned Royalties due for any year is discovered in any examination, then the Licensee shall bear the fees and expenses of such examination and shall remit such underpayment to The Regents within [*] of the examination results.

13.	
LIFE OF THE AGREEMENT

13.1 Unless otherwise terminated by operation of law, Paragraph 13.2 or by acts of the parties in accordance with the terms of this Agreement, this Agreement will remain in effect from the Effective Date until the expiration or abandonment of the last of the Patent Rights licensed hereunder.

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13.2 This Agreement will automatically terminate as permitted under applicable law without the obligation to provide [*] notice as set forth in Article 14 (Termination By The Regents) if a petition for relief under the United States Bankruptcy Code is filed by or against the Licensee as a debtor or alleged debtor and is not dismissed within [*] days after filing.

13.3 Any termination or expiration of this Agreement will not affect the rights and obligations set forth in the following Articles:

Article 1

  	Definitions
Paragraph 3.5

  	Survival of Sublicenses
Paragraph 4.8

  	Late Payments
Article 5

  	License Issue Fee and Indexed Milestone Payment
Article 7

  	Payments on Sublicenses
Article 8

  	Earned Royalties and Minimum Annual Royalties
Article 12

  	Books and Records
Article 13

  	Life of the Agreement
Article 16

Disposition of Licensed Products and Licensed Services on Hand Upon Termination or Expiration
Article 17

  	Use of Names and Trademarks
Article 18

  	Limited Warranty
Article 19

  	Limitation of Liability
Paragraphs 20.4 and 20.6	  	Patent Prosecution and Maintenance
Article 23

  	Indemnification
Article 24

  	Notices
Article 25

  	Assignability
Article 28

  	Governing Laws; Venue
Article 31

  	Confidentiality
Paragraph 32.7

  	HHMI Third Party Beneficiary Status

13.4 The termination or expiration of this Agreement will not relieve the Licensee of its obligation to pay any payments owed to The Regents at the time of such termination or expiration and will not impair any accrued right of The Regents, including the right to receive Earned Royalties in accordance with Articles 7 (Payments on Sublicenses), 8 (Earned Royalties and Minimum Annual Royalties) and 16 (Disposition of Licensed Products and Licensed Services Upon Termination or Expiration).

14.	
TERMINATION BY THE REGENTS

If the Licensee fails to perform or violates any material term of this Agreement, then The Regents may give written notice of such default (“Notice of Default”) to the Licensee. If the Licensee fails to repair such default within [*] after the effective date of such notice, then The Regents will have the right to immediately terminate this Agreement and its licenses by providing a written notice of termination (“Notice of Termination”) to the Licensee. For purposes hereof, Licensee shall be deemed to have failed to perform a material term if it, among other things, fails to (i) make any payment due to The Regents in accordance with this Agreement; (ii) perform the diligence obligations in accordance with and as described in Article 10; or (iii) submit progress and royalty reports in accordance with and as provided in Article 11.

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15.	
TERMINATION BY LICENSEE

The Licensee has the right at any time to terminate this Agreement by providing a Notice of Termination to The Regents. Moreover, the Licensee will be entitled to terminate the rights under Patent Rights on a country-by-country basis by giving notice in writing to The Regents. Termination of this Agreement (but not termination of Licensee’s obligation with respect to any patents or patent applications under Patent Rights, which termination is subject to Paragraph 20.6) will be effective [*] from the effective date of such notice.

16.	
DISPOSITION OF LICENSED PRODUCT AND LICENSED SERVICES UPON TERMINATION OR EXPIRATION

16.1 Upon termination (but not expiration) of this Agreement, within a period of [*] after the date of termination, the Licensee is entitled to (i) Sell all previously made or partially made Licensed Product, but no more and (ii) provide previously contracted-for Licensed Services, provided that the Sale or use of such Licensed Product and the provision of such Licensed Services are subject to the terms of this Agreement, including, but not limited to, the rendering of reports and payment of Earned Royalties and Sublicense Fees and any other payments therefor required under this Agreement. The Licensee will not otherwise make, use, Sell, offer for Sale or import Licensed Products or Licensed Services, or practice the Licensed Method after the date of termination.

16.2 If applicable Patent Rights exist at the time of any making, Sale, offer for Sale, or import of a Licensed Product or the time of any Sale, offer for Sale, or rendering of a Licensed Service, then Earned Royalties shall be paid at the times provided herein and Earned Royalty reports shall be rendered in connection therewith, notwithstanding the absence of applicable Patent Rights with respect to such Licensed Product or Licensed Service at any later time. Otherwise, no Earned Royalties shall be paid on the Sales of such product or service. Any fees

26

or other payments owed to The Regents under the terms of this Agreement at the time of expiration not based on the Sale of a Licensed Product or Licensed Service will be paid to The Regents at the time such fee or other payment would have been due had this Agreement not expired.

17.	
USE OF NAMES AND TRADEMARKS

Except as provided in this Article 17 below, nothing contained in this Agreement will be construed as conferring any right to either party to use in advertising, publicity or other promotional activities any name, trade name, trademark or other designation of the other party (including a contraction, abbreviation or simulation of any of the foregoing). Without the Licensee’s consent case-by-case, The Regents may list Licensee’s name as a licensee of technology from The Regents without further identifying the technology. Unless required by law or unless consented to in writing by Executive Director, Office of Technology Transfer of The Regents, the use by the Licensee of the name “The Regents of the University of California” or the name of any campus of the University of California in advertising, publicity or other promotional activities is expressly prohibited. Licensee may not use the name of HHMI or of any HHMI employee (including Drs. Jack Taunton and Kevan Shokat) in a manner that reasonably could constitute an endorsement of a commercial product or service; but that use for other purposes, even if commercially motivated, is permitted provided that (i) the use is limited to accurately reporting factual events or occurrences, and (ii) any reference to the name of HHMI or any HHMI employees in press releases or similar materials intended for public release is approved by HHMI in writing in advance

18.	
LIMITED WARRANTY

18.1 The Regents warrants to the Licensee that it has the lawful right to grant this license.

18.2 Except as expressly set forth in this Agreement, this license and the associated Invention, Patent Rights, Licensed Products, Licensed Services, and Licensed Methods are provided by The Regents WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. THE REGENTS MAKES NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY THAT THE INVENTION, PATENT RIGHTS, LICENSED PRODUCTS, LICENSED SERVICES, OR LICENSED METHODS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS.

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 	18.3	
This Agreement does not:

 	18.3.1	
express or imply a warranty or representation as to the validity, enforceability, or scope of any Patent Rights; or

 	18.3.2	
express or imply a warranty or representation that anything made, used, Sold, offered for Sale or imported or otherwise exploited under any license granted in this Agreement is or will be free from infringement of patents, copyrights, or other rights of third parties; or

 	18.3.3	
obligate The Regents to bring or prosecute actions or suits against third parties for patent infringement except as provided in Article 22 (Patent Infringement); or

 	18.3.4

confer by implication, estoppel or otherwise any license or rights under any patents or other rights of The Regents other than Patent Rights, regardless of whether such patents are dominant or subordinate to Patent Rights; or

 	18.3.5	
obligate The Regents to furnish any New Developments, know-how, technology or information not provided in Patent Rights.

19.	
LIMITATION OF LIABILITY

19.1 THE REGENTS WILL NOT BE LIABLE FOR ANY LOST PROFITS, COSTS OF PROCURING SUBSTITUTE GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY INFRINGEMENT OR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER SPECIAL DAMAGES SUFFERED BY LICENSEE, SUBLICENSEES, JOINT VENTURES OR AFFILIATES ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ALL CAUSES OF ACTION OF ANY KIND (INCLUDING TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY AND BREACH OF WARRANTY) EVEN IF THE REGENTS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

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19.2 EXCEPT AS SET FORTH IN ARTICLE 23 (INDEMNIFICATION), THE LICENSEE WILL NOT BE LIABLE FOR ANY LOST PROFITS, LOST BUSINESS, ENHANCED DAMAGES OR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER SPECIAL DAMAGES SUFFERED BY THE REGENTS ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ALL CAUSES OF ACTION OF ANY KIND (INCLUDING TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY AND BREACH OF WARRANTY) EVEN IF THE LICENSEE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

20.	
PATENT PROSECUTION AND MAINTENANCE

20.1 As long as the Licensee has paid Patent Prosecution Costs as provided for in this Article 20 (Patent Prosecution and Maintenance), The Regents will diligently prosecute and maintain the United States and foreign patents comprising the Patent Rights using counsel of its choice. The Regents’ counsel will take instructions only from The Regents. The Regents will provide the Licensee with copies of all relevant documentation reasonably in advance of any deadline for filing a response so that the Licensee will be informed of the continuing prosecution and would have an opportunity to comment upon such documentation, provided, however, that if the Licensee has not commented upon such documentation in a reasonable time for The Regents to sufficiently consider the Licensee’s comments prior to a deadline with the relevant government patent office, or The Regents must act to preserve the Patent Rights, The Regents will be free to respond without consideration of the Licensee’s comments, if any. The Licensee agrees to keep this documentation confidential as provided for in Article 31 (Confidentiality).

20.2 The Regents shall consider comments provided by the Licensee pursuant to Paragraph 20.1 and shall use reasonable efforts to amend any patent application to include claims reasonably requested by the Licensee to protect the products and services contemplated to be Sold, or the Licensed Method to be practiced, under this Agreement.

20.3 The Licensee will apply for an extension of the term of any patent included within the Patent Rights if appropriate under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or European, Japanese and other foreign counterparts of this Law. The Licensee shall prepare all documents and The Regents agrees to execute the documents and to take additional action as the Licensee reasonably requests in connection therewith. Licensee shall bear the costs relating to such application.

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20.4 The Licensee will bear the costs of preparing, filing, prosecuting and maintaining all United States and foreign patent applications contemplated by this Agreement (“Patent Prosecution Costs”). Patent Prosecution Costs billed by The Regents’ counsel will be rebilled to the Licensee and are due within [*] of rebilling by The Regents. The Regents will provide a copy of such invoices to Licensee upon request. These Patent Prosecution Costs will include, without limitation, patent prosecution costs for the Invention incurred by The Regents prior to the execution of this Agreement and any patent prosecution costs that may be incurred for patentability opinions, re-examination, re-issue, interferences, oppositions or inventorship determinations. Patent Prosecution Costs incurred by The Regents prior to the Effective Date equal approximately [*] and will be paid by the Licensee within [*]. The Regents acknowledges and agrees that as of the Amendment Effective Date, the Patent Prosecution Costs incurred by The Regents prior to the Effective Date have been paid by the Licensee by the applicable due date, and the Licensee has no outstanding obligations or liabilities under the preceding sentence as of such date.

20.5 The Licensee may request that The Regents obtain patent protection on the Invention in foreign countries, if available and if the Licensee so desires. The Regents will inform the Licensee of the deadlines for payment, filing or action to be taken to obtain patent protection on the Invention in foreign countries and Licensee will notify The Regents of its decision to obtain or maintain foreign patents, such notification to be provided not less than [*] prior to the deadline for any payment, filing or action to be taken in connection therewith or, if The Regents informs the Licensee of a deadline less than [*] prior to such deadline, as soon as reasonably practicable. This notice concerning foreign filing must be in writing, must identify the countries desired and must reaffirm the Licensee’s obligation to pay the Patent Prosecution Costs thereof. The absence of such a notice from the Licensee to The Regents will be considered an election not to obtain or maintain foreign Patent Rights.

20.6 The Licensee will be obligated to pay any Patent Prosecution Costs incurred during the [*] period after receipt by either party of a Notice of Termination when such costs are either incurred before the Notice of Termination was received or otherwise related to the termination, even if the invoices for such Patent Prosecution Costs are received by the Licensee

30

after the end of the [*] period following receipt of a Notice of Termination. The Licensee may terminate its obligation to pay Patent Prosecution Costs with respect to any given patent application or patent under Patent Rights in any or all designated countries upon [*] written notice to The Regents. The Regents may continue prosecution and/or maintenance of such application(s) or patent(s) at its sole discretion and expense, provided, however, that the Licensee will have no further right or licenses thereunder. Non-payment of Patent Prosecution Costs may be deemed by The Regents as an election by the Licensee not to maintain such application(s) or patent(s).

20.7 The Regents may file, prosecute or maintain patent applications or patents at its own expense in any country in which the Licensee has not elected to file, prosecute or maintain patent applications or patents in accordance with this Article 20 (Patent Prosecution and Maintenance) and those applications, resultant patents and patents will not be subject to this Agreement.

21.	
PATENT MARKING

The Licensee will mark all Licensed Products made, used or Sold under the terms of this Agreement or their containers in accordance with applicable patent marking laws.

22.	
PATENT INFRINGEMENT

22.1 In the event that The Regents (to the extent of the actual knowledge of the licensing professional responsible for the administration of this Agreement) or the Licensee learns of infringement of potential commercial significance of any patent licensed under this Agreement, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the “Infringement Notice”). During the period in which, and in the jurisdiction where, the Licensee has exclusive rights under this Agreement, neither The Regents nor the Licensee will notify a possible infringer of infringement or put such infringer on notice of the existence of any Patent Rights without first obtaining consent of the other, such consent not to be unreasonably withheld or delayed. If the Licensee puts such infringer on notice of the existence of any Patent Rights with respect to such infringement without first obtaining the written consent of The Regents and if a declaratory judgment action is filed by such infringer against The Regents, then Licensee’s right

31

to initiate a suit against such infringer for infringement under Paragraph 22.2 below will terminate immediately without the obligation of The Regents to provide notice to the Licensee. Both The Regents and the Licensee will use their diligent efforts to cooperate with each other to terminate such infringement without litigation.

22.2 If infringing activity of potential commercial significance by the infringer has not been abated within [*] following the date of an Infringement Notice, then the Licensee may institute suit for patent infringement against the infringer. The Regents may voluntarily join such suit at its own expense, but may not otherwise commence suit against the infringer for the acts of infringement that are the subject of the Licensee’s suit or any judgment rendered in that suit. The Licensee may not join The Regents as a party in a suit initiated by the Licensee without The Regents’ prior written consent, such written consent subject to the approval of the Board of the Regents of the University of California. If, in a suit initiated by the Licensee, The Regents is involuntarily joined other than by the Licensee, then the Licensee will pay any costs incurred by The Regents arising out of such suit, including but not limited to, any legal fees of counsel that The Regents selects and retains to represent it in the suit.

22.3 If, within [*] following the date of an Infringement Notice, infringing activity of potential commercial significance by the infringer has not been abated and if the Licensee has not brought suit against the infringer, then The Regents may institute suit for patent infringement against the infringer. If The Regents institutes such suit, then the Licensee may not join such suit without The Regents’ consent and may not thereafter commence suit against the infringer for the acts of infringement that are the subject of The Regents’ suit or any judgment rendered in that suit.

22.4 Notwithstanding anything to the contrary in this Agreement, in the event that the infringement or potential infringement pertains to an issued patent included within the Patent Rights and written notice is given under the Drug Price Competition and Patent Term Restoration Act of 1984 (and/or foreign counterparts of this Law), then the party in receipt of such notice under the Act (in the case of The Regents to the extent of the actual knowledge of the licensing officer responsible for the administration of this Agreement) shall provide the Infringement Notice to the other party promptly. If the time period is such that the Licensee will lose the right to pursue legal remedy for infringement by not notifying a third party or by not filing suit, the notification period and the time period to file suit set forth above will be shortened to permit Licensee to maintain its rights under the requirements under the Act.

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22.5 Any recovery or settlement received in connection with any suit will first be shared by The Regents and the Licensee equally to cover any litigation costs each incurred and next shall be paid to The Regents or the Licensee to cover any litigation costs it incurred in excess of the litigation costs of the other. In any suit [*], any recovery in excess of litigation costs will be shared between Licensee and The Regents as follows: (a) for any recovery [*]: (i) The Regents will receive [*] of the recovery if [*], (ii) The Regents will receive [*] of the recovery if [*], but [*], and (iii) The Regents will receive [*] of the recovery if [*]; and (b) for any recovery [*], The Regents will receive [*] of the recovery. In any suit [*], any recovery in excess of litigation costs will [*]. The Regents and the Licensee agree to be bound by all determinations of patent infringement, validity and enforceability (but no other issue) resolved by any adjudicated judgment in a suit brought in compliance with this Article 22 (Patent Infringement).

22.6 Any agreement made by the Licensee for purposes of settling litigation or other dispute shall comply with the requirements of Article 3 (Sublicenses) of this Agreement.

22.7 Each party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party who initiated the suit (unless such suit is being jointly prosecuted by the parties).

22.8 Any litigation proceedings will be controlled by the party bringing the suit. The Regents may be represented by counsel of its choice in any suit brought by the Licensee.

23.	
INDEMNIFICATION

23.1 The Licensee will, and will require its Sublicensees to, indemnify, hold harmless and defend The Regents, the sponsors of the research that led to the Invention , and any invention claimed in patents or patent applications under Patent Rights (including the Licensed Products, Licensed Services and Licensed Methods contemplated thereunder) and their employers, and the officers, employees and agents of any of the foregoing, against any and all claims, suits, losses, damage, costs, fees and expenses resulting from, or arising out of, the exercise of this license by Licensee, an Affiliate and/or a Joint Venture or of any sublicense by a Sublicensee. This indemnification will include, but not be limited to, any product liability. If

33

The Regents, in its sole discretion, believes that there will be a conflict of interest or it will not otherwise be adequately represented by counsel chosen by the Licensee to defend The Regents in accordance with this Paragraph 23.1, then The Regents may retain counsel of its choice to represent it and the Licensee will pay all expenses for such representation. HHMI and its trustees, officers, employees, and agents (collectively, “HHMI Indemnitees”) will be indemnified, defended by counsel acceptable to HHMI, and held harmless by the Licensee and its Sublicensees from and against any claim, liability, cost, expense, damage, deficiency, loss, or obligation of any kind or nature (including, without limitations, reasonable attorney’s fees and other costs and expenses of defense) based on, resulting from, arising out of, or otherwise relating to this Agreement or the exercise of this license by Licensee, an Affiliate, a Joint Venture and/or any Sublicensee, including without any limitation cause of action relating to product liability (collectively, “Claims”). The previous sentence will not apply to any Claim that is determined with finality by a court of competent jurisdiction to result solely from the gross negligence or willful misconduct of an HHMI Indemnitee. If HHMI, in its sole discretion, believes that there will be a conflict of interest or it will not otherwise be adequately represented by counsel chosen by the Licensee to defend the HHMI Indemnitees in accordance with this Paragraph 23.1, then HHMI may retain counsel of its choice to represent the HHMI Indemnitees, and the Licensee will pay all expenses for such representation.

23.2 The Licensee, at its sole cost and expense, will insure its activities in connection with any work performed hereunder by Licensee, an Affiliate, a Joint Venture, and/or a Sublicensee, and will obtain, keep in force, and maintain the following insurance:

 	23.2.1	
Commercial Form General Liability Insurance (contractual liability included) with limits as follows prior to first dosing in humans:

Each Occurrence

[*]

Products/Completed Operations Aggregate

[*]

Personal and Advertising Injury

[*]

General Aggregate (commercial form only)

[*]

As of the time of administration of first dosing in humans, the insurance limits shall be as follows:

[*]

[*]

[*]

[*]

34

If the above insurance is written on a claims-made form, it shall continue for [*] following termination or expiration of this Agreement. The insurance shall have a date of placement prior to or coinciding with the Effective Date of this Agreement; and

 	23.2.2	
Worker’s Compensation as legally required in the jurisdiction in which the Licensee is doing business.

23.3 The coverage and limits referred to in Paragraph 23.2.1 and 23.2.2 above will not in any way limit the liability of the Licensee under the terms of this Article 23 (Indemnification). Upon the execution of this Agreement, the Licensee will furnish The Regents with certificates of insurance evidencing compliance with all requirements. Such certificates will:

 	•	 	
Provide for thirty (30) days’ (ten (10) days for non-payment of premium) advance written notice to The Regents of any cancellation of insurance coverage; the Licensee will promptly notify The Regents of any material modification of the insurance coverage;

 	•	 	
Indicate that The Regents and HHMI has been endorsed as an additional insured(s) under the coverage described above in Paragraph 23.2.1; and

 	•

Include a provision that the coverage will be primary and will not participate with, nor will be excess over, any valid and collectable insurance or program of self-insurance maintained by The Regents and HHMI.

23.4 The Regents will promptly notify the Licensee in writing of any claim or suit brought against The Regents for which The Regents intends to invoke the provisions of this Article 23 (Indemnification). The Licensee will keep The Regents informed of its defense of any claims pursuant to this Article 23 (Indemnification). In the case of an HHMI Indemnitee, notice shall be given reasonably promptly following actual receipt of written notice thereof by an officer or attorney of HHMI. Notwithstanding the foregoing, the delay or failure of an HHMI Indemnitee to give prompt notice to Licensee of any Claim shall not affect the rights of such HHMI Indemnitee unless, and then only to the extent that, such delay or failure is prejudicial to or otherwise adversely affects Licensee. The Licensee will keep HHMI informed of its defense of any Claims pursuant to this Article 23.

35

24.	
NOTICES

24.1 Any notice or payment required to be given to either party under this Agreement will be in writing and will be deemed to have been properly given and to be effective as of the date specified below if delivered to the respective address given below or to another address as designated by written notice given to the other party:

 	24.1.1	
on the date of delivery if delivered in person; or

 	24.1.2	
on the date of mailing if mailed by first-class certified mail, postage paid; or

 	24.1.3

on the date of mailing if mailed by any global express carrier service that requires the recipient to sign the documents demonstrating the delivery of such notice or payment.

In the case of Licensee:

  	Principia Biopharma Inc.
  	400 East Jamie Court
  	Suite 302
  	South San Francisco, California 94080
  	Attention: President and Chief Executive Officer
In the case of The Regents:

  	THE REGENTS OF THE UNIVERSITY
  	OF CALIFORNIA
  	Office of Technology Management 185 Berry Street, Suite 4603
  	San Francisco, California 94107
  	Telephone: (415) 353-4472
  	Facsimile: (415) 348-1579
  	Attention:     Director
  	RE:     UC Case Nos. SF2003-057 & SF2009-119
Payments to The Regents should be directed to:

  	Office of Technology Transfer
  	Attn.: Accounts Receivable
  	University of California
  	Office of the President

1111 Franklin Street, 5th Floor
  	Oakland, California 94607-5200
 
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25.	
ASSIGNABILITY

This Agreement is personal to the Licensee. The Licensee may assign or transfer this Agreement, without The Regents’ prior written consent, only in the case of assignment or transfer to a party that succeeds to all or substantially all of Licensee’s business or assets relating to this Agreement, whether by sale, merger, operation of law or otherwise, provided that such assignee or transferee promptly agrees to be bound by the terms and conditions of this Agreement and signs The Regents’ standard substitution of party letter (the form of which is attached hereto as Appendix A). Any attempted assignment by Licensee other than in accordance with this Paragraph 25 will be null and void. This Agreement is binding upon and will inure to the benefit of The Regents, its successors and assigns.

26.	
WAIVER

No waiver by either party of any breach or default of any of the agreements contained herein will be deemed a waiver as to any subsequent and/or similar breach or default. No waiver will be valid or binding upon the parties unless made in writing and signed by a duly authorized officer of each party.

27.	
FORCE MAJEURE

27.1 Except for the Licensee’s obligation to make any payments to The Regents hereunder, the parties shall not be responsible for any failure to perform due to the occurrence of any events beyond their reasonable control which render their performance impossible or onerous, including, but not limited to: accidents (environmental, toxic spill, etc.); acts of God; biological or nuclear incidents; casualties; earthquakes; fires; floods; governmental acts; orders or restrictions; inability to obtain suitable and sufficient labor, transportation, fuel and materials; local, national or state emergency; power failure and power outages; acts of terrorism; strike; and war.

27.2 Either party to this Agreement, however, will have the right to terminate this Agreement upon [*] prior written notice if either party is unable to fulfill its obligations under this Agreement due to any of the causes specified in Paragraph 27.1 for a period of [*].

28.	
GOVERNING LAWS; VENUE

28.1 THIS AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, excluding any choice of law rules that would direct the application of the laws of another jurisdiction and without regard to which party drafted particular provisions of this Agreement, but the scope and validity of any patent or patent application will be governed by the applicable laws of the country of such patent or patent application.

37

28.2 Any legal action brought by the parties hereto relating to this Agreement will be conducted in San Francisco, California.

29.	
GOVERNMENT APPROVAL OR REGISTRATION

If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, the Licensee will assume all legal obligations to do so. The Licensee will notify The Regents if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. The Licensee will make all necessary filings and pay all costs including fees, penalties and all other out-of-pocket costs associated with such reporting or approval process.

30.	
COMPLIANCE WITH LAWS

The Licensee shall comply with all applicable international, national, state, regional and local laws and regulations in performing its obligations hereunder and in its use, manufacture, Sale or import of the Licensed Products, Licensed Services or practice of the Licensed Method. The Licensee will observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data and the provision of Licensed Services to foreign countries, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations. The Licensee shall manufacture Licensed Products and practice the Licensed Method in compliance with applicable government importation laws and regulations of a particular country for Licensed Products made outside the particular country in which such Licensed Products are used, Sold or otherwise exploited.

31.	
CONFIDENTIALITY

31.1 The Licensee and The Regents will treat and maintain the other party’s proprietary business, patent prosecution, software, engineering drawings, process and technical information and other proprietary information, including the negotiated terms of this Agreement and any progress reports and royalty reports and any sublicense agreement issued pursuant to this Agreement (“Proprietary Information”) in confidence using at least the same degree of care as the receiving party uses to protect its own proprietary information of a like nature from the date of disclosure until [*] after the termination or expiration of this Agreement. This confidentiality obligation will apply to the information defined as “Data” under the Mutual Nondisclosure Agreement and such Data will be treated as Proprietary Information hereunder.

38

31.2 The Licensee and The Regents may use and disclose Proprietary Information to their employees, agents, consultants, contractors and, in the case of the Licensee and its Sublicensees, provided that such parties are bound by a like duty of confidentiality as that found in this Article 31 (Confidentiality). In addition, the Licensee may disclose the terms of this Agreement to any bona fide potential or actual investor, investment banker, acquirer, merger partner, or other potential or actual financial partner, provided that such parties are bound by a like duty of confidentiality as that found in this Article 31. Notwithstanding anything to the contrary contained in this Agreement, The Regents may release this Agreement or any sublicense, including any terms thereof, and information regarding royalty payments or other income received in connection with this Agreement to the inventors, senior administrative officials employed by The Regents and individual Regents and to the senior administrative officials employed by HHMI and individual trustees of HHMI upon their request. If such release is made, The Regents will request that such terms be kept in confidence in accordance with the provisions of this Article 31 (Confidentiality). In addition, notwithstanding anything to the contrary in this Agreement, if a third party inquires whether a license to Patent Rights is available, then The Regents may disclose the existence of this Agreement and the extent of the grant in Articles 2 (Grant) and 3 (Sublicenses) and related definitions to such third party, but will not disclose the name of the Licensee unless Licensee has already made such disclosure publicly.

31.3 All written Proprietary Information will be labeled or marked confidential or proprietary. If the Proprietary Information is orally disclosed, it will be reduced to writing or some other physically tangible form, marked and labeled as confidential or proprietary by the disclosing party and delivered to the receiving party within [*] after the oral disclosure.

31.4 Nothing contained herein will restrict or impair, in any way, the right of the Licensee or The Regents to use or disclose any Proprietary Information:

 	31.4.1	
that recipient can demonstrate by written records was previously known to it prior to its disclosure by the disclosing party;

39

31.4.2	
that recipient can demonstrate by written records is now, or becomes in the future, public knowledge other than through acts or omissions of recipient;

 	31.4.3	
that recipient can demonstrate by written records was obtained lawfully and without restrictions on the recipient from sources independent of the disclosing party;

 	31.4.4	
that recipient can demonstrate from written records was developed by or for the receiving party without reference to confidential information disclosed by the disclosing party; and

 	31.4.5	
that The Regents is required to disclose pursuant to the California Public Records Act or other applicable law.

The Licensee or The Regents also may disclose Proprietary Information that is required to be disclosed (i) to a governmental entity or agency in connection with seeking any governmental or regulatory approval, governmental audit, or other governmental contractual requirement or (ii) by law, provided that the recipient uses reasonable efforts to give the party owning the Proprietary Information sufficient notice of such required disclosure to allow the party owning the Proprietary Information reasonable opportunity to object to, and to take legal action to prevent, such disclosure.

31.5 Upon termination of this Agreement, the Licensee and The Regents will destroy or return any of the disclosing party’s Proprietary Information in its possession within [*] following the termination of this Agreement. The Licensee and The Regents will provide each other, within [*] following termination, with written notice that such Proprietary Information has been returned or destroyed. Each party may, however, retain one copy of such Proprietary Information for archival purposes in non-working files.

32.	
MISCELLANEOUS

32.1 The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

32.2 This Agreement is not binding on the parties until it has been signed below on behalf of each party. It is then effective as of the Effective Date.

40

32.3 No amendment or modification of this Agreement is valid or binding on the parties unless made in writing and signed on behalf of each party.

32.4 This Agreement embodies the entire understanding of the parties and supersedes all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof. The Mutual Nondisclosure Agreement dated March 6, 2009 is hereby superseded.

32.5 In case any of the provisions contained in this Agreement is held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect any other provisions of this Agreement and this Agreement will be construed as if such invalid, illegal or unenforceable provisions had never been contained in it.

32.6 This Agreement includes the attached Appendices A and B.

32.7 No provisions of this Agreement are intended or shall be construed to confer upon or give to any person or entity other than The Regents and the Licensee any rights, remedies or other benefits under, or by reason of, this Agreement. HHMI is not a party to this Agreement and has no liability to Licensee, any sublicensee, or user of anything covered by this Agreement, but HHMI is an intended third-party beneficiary of this Agreement and certain of its provisions are for the benefit of HHMI and are enforceable by HHMI in its own name.

32.8 In performing their respective duties under this Agreement, each of the parties will be operating as an independent contractor. Nothing contained herein will in any way constitute any association, partnership, or joint venture between the parties hereto, or be construed to evidence the intention of the parties to establish any such relationship. Neither party will have the power to bind the other party or incur obligations on the other party’s behalf without the other party’s prior written consent.

32.9 This Agreement may be executed in counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument.

41

IN WITNESS WHEREOF, both The Regents and the Licensee have executed this Agreement, in duplicate originals, by their respective and duly authorized officers on the day and year written.

PRINCIPIA BIOPHARMA INC.	  	THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
By:	  	
/s/ Martin Babler

  	By:	  	
/s/ Karin H. Immergluck

  	(Signature)	  		  	(Signature)
Name:	  	
Martin Babler

  	Name:	  	
Karin H. Immergluck

  	(Please Print)	  		  	(Please Print)
Title:	  	
CEO

  	Title:	  	
Acting Director

Date:	  	
5-9-2012

  	Date:	  	
06/01/2012

APPENDIX A

This substitution of parties (“Agreement”) is effective this                    day of            , 200    , among The Regents of the University of California (“The Regents”), a California corporation, having its statewide administrative offices at 1111 Franklin Street, 12th Floor, Oakland, California 94607-5200 and acting through its Office of Technology Management, University of California San Francisco (“UCSF”), 185 Berry Street, Suite 4603, San Francisco, California 94107; PRINCIPIA BIOPHARMA INC. (“Principia”), a                     corporation, having a principal place of business at 400 East Jamie Court, Suite 302, South San Francisco, California 94080; and [new licensee name] [(“YYY”)] a                 corporation, having a principal place of business at                                                         .

A.The Regents and Principia entered into a License Agreement effective                 (UC Control No.         -        -            ), entitled                                          (“License Agreement”), wherein Principia was granted certain rights.

B. Principia desires that [YYY] be substituted as Licensee (defined in the License Agreement) in place of Principia, and The Regents is agreeable to such substitution.

C. [YYY] has read the License Agreement and agrees to abide by its terms and conditions.

1. [YYY] assumes all liability and obligations under the License Agreement and is bound by all its terms in all respects as if it were the original Licensee of the License Agreement in place of Principia.

2. [YYY] is substituted for Principia, provided that [YYY] assumes all liability and obligations under the License Agreement as if [YYY] were the original party named as Licensee as of the effective date of the License Agreement.

1

3.    The Regents releases Principia from all liability and obligations under the License Agreement arising before or after the effective date of this Agreement.

The parties have executed this Agreement in triplicate originals by their respective authorized officers on the following day and year.

By:

By:	  	
                                                                                       
Name:	  	
                                                                                   
  	Name:	  	
 
Title:	  	
                                                                   
  	Title:	  	
Director,

Office of Technology Management

Date:	  	
                                                                       
  	Date:	  	
                                                                                           
[YYY] COMPANY

By:

(Signature)

Name:

(Please Print)

Title:

Date:

2

APPENDIX B

MATERIAL TRANSFER AGREEMENT

Re:      UCSF Docket SF2003-057 and SF2009-119, [“RSK Inhibitors and Novel Electrophiles”]

Howard Hughes Medical Institute (“HHMI”) and the Regents of the University of California, acting on behalf of the University of California, San Francisco (“UCSF”; HHMI and UCSF referred to collectively herein as “Provider”), agrees to provide                                having a business address at                         (“RECIPIENT”) with certain research material requested by RECIPIENT for use by its scientist,             (“Scientist”), subject to the terms and conditions set forth in this Material Transfer Agreement (the “Agreement”).

1. The Agreement applies to the transfer of the             compounds and to any progeny, unmodified derivatives, or portions thereof (collectively, the “Material”) for use only in scientific research relating to the study of                     (the “Research”). The Material is being made available by Dr. Jack Taunton (“Investigator”) a Howard Hughes Medical Institute (“HHMI”) investigator and resulted from research conducted by Investigator at UCSF.

2. Legal title to the Material shall be unaffected by this Agreement or the transfer made hereunder, and nothing in the Agreement grants RECIPIENT any rights under any patents nor any rights to use the Material or any product(s) or process(es) derived from or with the Material for profit-making or commercial purposes. Nothing in this Agreement shall alter any rights the U.S. Government may have with respect to the Material. Except as otherwise provided in paragraph 10 of this Agreement, RECIPIENT and Scientist shall maintain the confidentiality of Provider’s proprietary information relating to the Material. RECIPIENT will hold the Material in trust solely for the purposes set forth in this Agreement.

3. UCSF has filed patent applications covering inventions relating to the Material. The Material is the subject of U.S. Patent Application Number [                     ] and assigned to The Regents of the University of California and are the subjects of an exclusive license agreement with Principia Biopharma.

4. The transfer of the Material constitutes a non-exclusive license to use the Material solely for the internal scientific research of RECIPIENT. This Agreement does not restrict UCSF’s rights to distribute the Material to other commercial or non-commercial entities. RECIPIENT agrees to negotiate in good faith a license with UCSF or UCSF’s exclusive licensee prior to making any profit-making or commercial use of the Material or any product(s) or process(es) derived from or incorporating the Material, including the screening of drug candidates. UCSF shall have no obligation to grant such a license to RECIPIENT.

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5. The Material is provided to RECIPIENT for use in animals or in vitro. The Material will not be used in humans, including for purposes of diagnostic testing.

6. Any party may terminate this Agreement at any time in which case RECIPIENT will discontinue within thirty days its use of the Material until such time as a new agreement between and among the parties is established. If no new agreement is established within sixty days, RECIPIENT agrees, upon direction of Provider, to return or destroy the Material. The provisions of paragraphs 2 and 4, above, (except for the non-exclusive license) shall survive any termination of this Agreement. For the avoidance of doubt, surviving any termination or expiration of this Agreement (unless provided otherwise by Provider and RECIPIENT), is the agreement by RECIPIENT that RECIPIENT shall not use the Material or any product(s) or process(es) derived from or with the Material if for profit-making or commercial purposes.

7. Neither Scientist nor RECIPIENT nor any other person authorized to use the Material under the Agreement shall make available the Material or any portion of the Material to any person or entity other than laboratory personnel under the Scientist’s immediate and direct control. No person authorized to use the Material shall be allowed to take or send the Material to any location other than the Scientist’s laboratory without Provider’s prior written consent.

8. The Material is experimental in nature and shall be used with prudence and appropriate caution, since not all of its characteristics are known. THE MATERIAL IS PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. UCSF AND HHMI MAKE NO REPRESENTATION OR WARRANTY THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.

9. If the Scientist and RECIPIENT wish to publish results of the Research, Scientist or RECIPIENT will furnish Provider with a copy of the manuscript or abstract disclosing such results prior to submission thereof to any publisher not less than thirty (30) days prior to publication to allow Provider opportunity to protect proprietary or intellectual property relating to the Material that might be contained in such disclosure. The RECIPIENT shall notify UCSF promptly after filing any patent applications claiming inventions made in the course of using the Material, and UCSF shall have the right to notify Principia Biopharma of such filings.

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10. Scientist and RECIPIENT shall acknowledge Provider as the source of the Material in any publication of Research results.

11. The RECIPIENT shall, at the request of the Provider, return or destroy all unused Material.

12. In no event shall UCSF or HHMI be liable for any use by Scientist or RECIPIENT of the Material or for any loss, claim, damage, or liability, of any kind or nature, that may arise from or in connection with this Agreement or the use, handling, or storage of the Material. The RECIPIENT hereby agrees to defend, indemnify and hold harmless HHMI, UCSF and UCSF’s trustees, regents, officers, agents, and employees from any liability, claim, loss, or damage of whatsoever kind or nature that they may suffer as a result of claims, demands, costs, or judgments against them arising out of the use or disposition of the Material by the Scientist or the RECIPIENT.

13. Scientist and RECIPIENT will use the Material in compliance with all laws, governmental regulations and guidelines, including without limitation current NIH guidelines and any regulations or guidelines pertaining to research with recombinant DNA, that may be applicable to the Material.

14. This Agreement is not assignable.

15. This Agreement shall be governed by California State law. The parties hereby submit to the exclusive jurisdiction of the courts of the State of California in all matters concerning this Agreement.

AGREED AND ACCEPTED:

PRINCIPIA BIOPHARMA INC.	  	HOWARD HUGHES MEDICAL INSTITUTE
Signature:                                                                              

Signature:

Name:                                                                                  	  	Name:                                                                           
Title:                                                                                    	  	Title:                                                                           
Date:                                                                                   	  	Date:                                                                            
 
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RECIPIENT:

[Note: must be signed by authorized officer]

Name:                                                                                  	  	
Title:                                                                                    	  	
Date:                                                                                   	  	
RECIPIENT SCIENTIST:

Name:                                                                                  	  	
Title:                                                                                    	  	
Date:

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