Document:

Exhibit

Exhibit 10.2

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

LICENSE AND DEVELOPMENT AGREEMENT
by and between
SELECTA BIOSCIENCES, INC.
and
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
June 11, 2020

SEL-212

CONTENTS

	
				
	Clause
	 
	 
	Page

	1.
	DEFINITIONS
	1

	 
	1.1
	Defined Terms
	1

	 
	1.2
	Interpretation
	16

	2.
	GRANT OF RIGHTS; Non-Compete
	17

	 
	2.1
	License Grant
	17

	 
	2.2
	Additional Obligation of Licensor
	17

	 
	2.3
	Right to Sublicense
	19

	 
	2.4
	Disclosure of Licensed Know-How
	19

	 
	2.5
	Reservation of Rights
	20

	 
	2.6
	Combination Products
	20

	 
	2.7
	Upstream Agreements
	20

	 
	2.8
	ImmTOR Trademarks License
	21

	 
	2.9
	No Other Rights
	21

	 
	2.10
	Non-Compete
	22

	 
	2.11
	[***]
	22

	3.
	GOVERNANCE
	22

	 
	3.1
	Joint Steering Committee
	22

	 
	3.2
	Decision Making
	24

	 
	3.3
	Limitations on Decisions
	24

	 
	3.4
	Good Faith
	24

	 
	3.5
	General JSC Authority
	24

	4.
	DEVELOPMENT
	25

	 
	4.1
	Overview of Development, Diligence
	25

	 
	4.2
	Development Plan, Development Budget, Reimbursement
	25

	 
	4.3
	Development Activities
	25

	5.
	COMMERCIALIZATION
	28

	 
	5.1
	Diligence
	28

	 
	5.2
	Trademark Use
	28

	 
	5.3
	Commercialization Updates
	28

	6.
	PAYMENTS
	28

	 
	6.1
	Up-Front Payment
	28

	 
	6.2
	Development and Regulatory Milestone Payments
	29

	 
	6.3
	Sales Milestone Payments
	30

i

	
				
	 
	6.4
	Royalty
	30

	 
	6.5
	Royalty Reductions
	31

	 
	6.6
	Payment and Reports
	31

	 
	6.7
	Other Amounts Payable
	32

	7.
	RECORD KEEPING, AUDIT RIGHTS
	32

	 
	7.1
	Record Keeping
	32

	 
	7.2
	Audit Rights
	32

	 
	7.3
	Taxes
	33

	 
	7.4
	Late Payments
	34

	8.
	REGULATORY
	34

	 
	8.1
	Regulatory Matters
	34

	 
	8.2
	Regulatory Transfer
	35

	 
	8.3
	Regulatory Support
	35

	 
	8.4
	Licensee Access
	36

	 
	8.5
	Licensor Access
	36

	 
	8.6
	Adverse Event Reporting, Safety Agreement
	37

	 
	8.7
	Regulatory Action Letters
	37

	 
	8.8
	Regulatory Meetings
	37

	 
	8.9
	Global Safety Database
	37

	9.
	INTELLECTUAL PROPERTY RIGHTS
	37

	 
	9.1
	Inventorship
	37

	 
	9.2
	Ownership.
	38

	 
	9.3
	Patent Prosecution and Maintenance
	38

	 
	9.4
	Infringement or misappropriation of Licensed Technology [***]
	41

	 
	9.5
	Third Party Infringement Claims
	43

	 
	9.6
	Defense
	44

	 
	9.7
	Common Interest
	44

	 
	9.8
	Third Party Patent Rights
	44

	 
	9.9
	Personnel Obligations
	44

	 
	9.10
	Rights in Bankruptcy
	45

	10.
	CONFIDENTIAL INFORMATION
	45

	 
	10.1
	Confidentiality
	45

	 
	10.2
	Publicity
	47

	 
	10.3
	Equitable Relief
	47

	11.
	TRANSPARENCY, DATA PROTECTION
	48

	 
	11.1
	Transparency
	48

	 
	11.2
	Data Protection
	48

ii

	
				
	12.
	REPRESENTATIONS, WARRANTIES AND COVENANTS
	49

	 
	12.1
	Mutual Representations and Warranties
	49

	 
	12.2
	Additional Representations and Warranties of Licensor
	50

	13.
	SUPPLY
	53

	 
	13.1
	Supply for Existing Pivotal Trials
	53

	 
	13.2
	Supply Agreement
	53

	 
	13.3
	Supply Price
	53

	 
	13.4
	Second Source Supplier; Technology Transfer
	54

	 
	13.5
	Cell Bank
	55

	 
	13.6
	Quality Agreements
	55

	14.
	INDEMNIFICATION
	55

	 
	14.1
	Indemnification by Licensor
	55

	 
	14.2
	Indemnification by Licensee
	56

	 
	14.3
	Indemnification Procedures
	56

	 
	14.4
	Insurance
	57

	15.
	LIMITATION OF LIABILITY
	57

	 
	15.1
	LIMITS
	57

	 
	15.2
	KNOWLEDGE
	57

	16.
	TERM AND TERMINATION
	58

	 
	16.1
	Term
	58

	 
	16.2
	Termination of Agreement for Material Breach
	58

	 
	16.3
	Termination of Agreement for Bankruptcy
	58

	 
	16.4
	Termination of Agreement for Patent Challenge
	58

	 
	16.5
	Termination of Agreement by Licensee
	59

	 
	16.6
	Effects of Termination by Licensor for Cause or by Licensee for Convenience
	59

	 
	16.7
	Effect of Termination by Licensee for Cause
	60

	 
	16.8
	Licensor’s Insolvency
	60

	 
	16.9
	Survival
	61

	17.
	DISPUTE RESOLUTION
	61

	 
	17.1
	Governing Law
	61

	 
	17.2
	Dispute Resolution
	61

	18.
	HSR FILINGS AND CLOSING
	63

	 
	18.1
	HSR Filings
	63

iii

	
				
	19.
	MISCELLANEOUS
	64

	 
	19.1
	No Benefit to Third Parties
	64

	 
	19.2
	Relationship of the Parties
	64

	 
	19.3
	Unenforceability
	64

	 
	19.4
	Waiver and Non-Exclusion of Remedies
	65

	 
	19.5
	Assignment; Securitization
	65

	 
	19.6
	Injunctive Relief
	66

	 
	19.7
	English Language
	66

	 
	19.8
	Notices
	66

	 
	19.9
	Force Majeure
	67

	 
	19.10
	Headings
	67

	 
	19.11
	Set Off
	67

	 
	19.12
	Costs and Expenses
	67

	 
	19.13
	Further Assurance
	67

	 
	19.14
	Amendment
	67

	 
	19.15
	Counterparts
	67

	 
	19.16
	Entire Agreement
	67

	 
	 
	 
	 

	 
	 
	 
	 

	ANNEX A    LICENSED PATENTS
	 

	ANNEX A-1    COMPOUND PATENTS
	 

	ANNEX A-2    EXISTING 212 PATENTS
	 

	ANNEX B    COMPOUND, IMMTOR AND SEL-212
	 

	ANNEX C    DATA PROTECTION
	 

	ANNEX D    PRESS RELEASES
	 

	ANNEX E    PERMITTED MATERIAL SUBCONTRACTORS
	 

	ANNEX F    SUPPLY AGREEMENT AND QUALITY AGREEMENT TERMS
	 

	ANNEX G     IMMTOR [***]
	 

	ANNEX H     [***]
	 

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LICENSE AND DEVELOPMENT AGREEMENT
THIS LICENSE AND DEVELOPMENT AGREEMENT (“Agreement”) dated as of June 11, 2020 (the “Execution Date”) is by and between SELECTA BIOSCIENCES, INC., a Delaware corporation having its principal place of business at 65 Grove Street, Watertown, MA 02472 (“Licensor”) and SWEDISH ORPHAN BIOVITRUM AB (publ), a Swedish public company having its principal place of business at SE-112 76 Stockholm, Sweden (“Licensee”).  Licensor and Licensee are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Licensee is a biopharmaceutical company focused on developing and commercializing therapies for rare diseases;
WHEREAS, Licensor is the owner of all right, title and interest in, or otherwise has the right to license, the Licensed Technology  (as hereinafter defined); and
WHEREAS, Licensor desires to grant, and Licensee desires to accept, a License (as hereinafter defined) under such Licensed Technology to Develop, Manufacture and Commercialize the Products in the Field in the Territory (each as hereinafter defined) on the terms and conditions set forth herein.
AGREEMENT
NOW, THEREFORE, for and in consideration of the above-described recitals, the mutual promises and covenants of the parties hereinafter contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the Parties, the Parties hereto, intending to be legally bound, enter into the agreements contained herein.

1.    DEFINITIONS

1.1    Defined Terms.  For purposes of this Agreement, the following terms shall have the meanings set forth below: 
“3SBio” shall mean Shenyang Sunshine Pharmaceutical Co., Ltd.
“3SBio Agreements” shall mean the 3SBio License Agreement and the 3SBio Supply Agreement.
“3SBio Breach Notice” shall have the meaning set forth in Section 2.2.13.
“3SBio License Agreement” shall mean the Amended and Restated License Agreement between Licensor and 3SBio dated 31 May 2017.
“3SBio Supply Agreement” shall mean the Commercial Supply Agreement between Licensor and 3SBio dated 1 August 2019.
“AAA” shall have the meaning set forth in Section 17.2.7(a).
“Accounting Standards” shall mean, with respect to Licensor, GAAP, with respect to Licensee, IFRS (International Financial Reporting Standards), and, with respect to Sublicensees, IFRS or GAAP, as applicable, in each case as generally and consistently applied throughout the Party’s or Sublicensee’s organization.  Each Party will promptly notify the other Party if such Party changes the Accounting Standards pursuant to which its records relating to this Agreement are maintained; provided, however, that each Party may only use internationally recognized accounting principles (e.g., IFRS or US GAAP).

1

“Acquisition Entity” shall mean, collectively, (a) with respect to the acquisition of a Party by a Third Party, a Third Party referenced in the definition of Change of Control and such Third Party’s Affiliates, other than the applicable Party in the definition of Change of Control and such Party’s Affiliates (determined as of immediately prior to the closing of such Change of Control), and (b) with respect to the acquisition by a Party of a Third Party (whether by a merger, consolidation, recapitalization, reorganization, sale or other transfer of voting securities, or sale or other transfer of substantially all of such Third Party’s and its controlled Affiliates’ assets), such Third Party and its Affiliates, other than the applicable acquiring Party, and such Party’s Affiliates (determined as of immediately prior to the closing of such acquisition transaction).
“Acting Party” shall have the meaning set forth in Section 7.3.2
“Additional Compound Development Activities” shall have the meaning set forth in Section 4.3.2.
“Additional ImmTOR Development Activities” shall have the meaning set forth in Section 4.3.2.
“Adverse Event” shall mean any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of the Compound, ImmTOR or a Product whether or not considered related to the Compound, ImmTOR and / or Product.
“Affiliate” shall mean, with respect to either Party, any person or entity which, directly or indirectly, controls, is controlled by, or is under common control with, the specified Party.  For the purposes of this definition, the term “control”, as applied to any person or entity (including, with correlative meaning, the terms “controlled by” and “under the common control”), means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such Party, whether by the ownership of more than fifty percent (50%) of the voting stock of such Party, by contract or otherwise.
“Agreement” shall have the meaning set forth in the introduction to this document. 
“Annual Net Sales” [***] 
“Bankruptcy Code” shall have the meaning set forth in Section 9.10.1. 
[***]
[***]
[***]
“Biosimilar Product” shall mean, with respect to a Product in a country, a biologic product that (a) is marketed for sale in such country by a Third Party (including an Acquisition Entity of Licensor) (not licensed, supplied, or otherwise permitted by Licensee, its Affiliates or its Sublicensees); (b) contains (i) the active pharmaceutical ingredient or biologic of the Compound or a substantial equivalent to the active pharmaceutical ingredient or biologic of the Compound as an active pharmaceutical ingredient or biologic in such country, together with (ii) the active pharmaceutical ingredient or biologic of ImmTOR or a substantial equivalent to the active pharmaceutical ingredient or biologic of ImmTOR and (c) for which its Regulatory Approval in such country references or relies on safety and efficacy clinical data submitted by Licensor or any of its Affiliates or (sub)licensees to obtain Regulatory Approval for such Product in such country.
“BLA” shall mean a Biologic License Application for a Product requesting permission to place a biological product on the market in accordance with 21 C.F.R. Part 601, and all supplements or 

2

amendments thereto, filed pursuant to the requirements of the FDA, or an equivalent application in the event that the FDA determines that a New Drug Application (NDA) rather than a BLA is the appropriate mechanism for requesting such approval.
“Business Day” shall mean a day other than a Saturday, Sunday or a bank or other public holiday in Massachusetts or New York in the United States or in Stockholm in Sweden.
“Cell Bank” shall mean a cell bank of a characterized bank of cells expressing the Compound.
“cGMP” shall mean the requirements of applicable Laws governing the Manufacture of biological and pharmaceutical products, including as provided for (and amended from time to time) in 21 C.F.R. Parts 210 and 211 et seq., European Commission Directive 2003/94/EC and guidelines issued from time to time by the ICH, as amended and supplemented from time to time, or equivalent Laws in other jurisdictions.
“Change of Control” shall mean, with respect to a Party, (a) a merger, consolidation, recapitalization, or reorganization of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger, consolidation, recapitalization, reorganization, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party, (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s and its controlled Affiliates’ assets or (d) entry into such other arrangement or agreement whereby the current shareholders of such Party no longer have the actual power, either directly or indirectly, to appoint a majority of the board of directors.  Notwithstanding the foregoing, any transaction or series of transactions effected for the purpose of financing the operations of the applicable Party (such as an initial public offering or other offering of equity securities to non-strategic investors) will not be deemed a “Change of Control” for purposes of this Agreement.
“Chronic Refractory Gout” shall mean  the treatment of chronic gout in adult patients refractory to conventional therapy.
“Claim” shall mean any charge, allegation, civil, criminal or administrative claim, demand, complaint, cause of action, suit, or Proceeding.
“CMC Activities” shall mean chemistry manufacturing controls and related activities in support of Regulatory Filings and Regulatory Approvals for the Product.
“Combination Product” shall mean, on a Product-by-Product basis, (a) any biological or pharmaceutical product that contains or comprises (i) such Product and (ii) at least one other active pharmaceutical or biologic ingredient, either co-formulated or packaged together or otherwise sold as a single unit for a single price, (b) a Product that is sold for a single price together with any (i) delivery device or component therefor, (ii) diagnostic product, process, service, or therapy, or (iii) product, process, service, or therapy other than such Product, or (c) a Product that is defined as a “combination product” by the FDA pursuant to 21 C.F.R. § 3.2(e) or its foreign equivalent.
“Commercialization” shall mean any and all activities directed to the launch of, offering for sale of or sale of a Product, including activities related to marketing, promoting, detailing, distributing, importing, exporting, offering to sell or selling such Product, interacting with Regulatory Authorities regarding any of the foregoing and seeking pricing or reimbursement approvals (as applicable).  When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning. 

3

“Commercially Reasonable Efforts” shall mean (a) with respect to efforts to be expended by a Party to achieve an agreed objective, except as provided for in clause (b), such reasonable, diligent and good faith efforts as [***]. 
“Competitive Infringement” shall have the meaning set forth in Section 9.4.1. 
“Compound” shall mean (a) the compound SEL-037, known as Pegadricase (formerly known as Pegsiticase), as further defined in Annex B, a recombinant uricase derived from Candida Utilis and pegylated with 20kDA mPEG, and (b) any back-up compounds or any other forms thereof, including uricase, monomeric uricase, aggregated uricase, mixtures of monomeric and aggregated uricase, uricase of alternative natural or modified amino acid sequence, uricase with incorporation of non-natural amino acid(s) or amino acid derivatives or analogs; (c) any compounds from any of those identified in clauses (a) or (b) conjugated with any linker or linked to any other molecular entity, including those compounds linked to the same or other PEG molecules; (d) any salts, prodrugs, esters, amides, active metabolites, solvates, intermediates, fragments, derivatives (including pegylated versions and any linkers thereof), analogs and polymorphs of any compounds covered by the foregoing clauses (a), (b), (c) or this clause (d), and (e) any improvements to any of the foregoing covered by the foregoing clauses (a), (b), (c), (d) or this clause (e).  
“Compound Know-How” shall mean (a) all Know-How licensed to Licensor pursuant to any of the 3SBio Agreements; and (b) all Know-How solely related to the Compound and reasonably necessary or reasonably useful for the Exploitation of the Product in the Field in the Territory, in the case of (b) to the extent such Know-How is Controlled by Licensor or its Affiliates as of immediately prior to the Effective Date or during the Term and is not otherwise covered by (a).
“Compound Patents” shall mean (a) all Patents licensed to Licensor pursuant to any of the 3SBio Agreements; and (b) all Patents solely related to the Compound and reasonably necessary or reasonably useful for the Exploitation of the Product in the Field in the Territory, in the case of (b) to the extent such Patents are Controlled by Licensor or its Affiliates as of immediately prior to the Effective Date or during the Term and are not otherwise covered by (a).  Compound Patents existing as of the Execution Date are set forth in Annex A-1. 
“Confidential Information” of a Party shall mean all Know-How, unpublished patent applications, and other information and data of a financial, commercial, business, operational, scientific or technical nature of such Party that is: (a) disclosed by or on behalf of such Party or any of its Affiliates or otherwise made available to the other Party or any of its Affiliates, whether made available orally, in writing, or in electronic form or (b) learned by the other Party pursuant to this Agreement.  The terms and conditions of this Agreement are the Confidential Information of both Parties. Notwithstanding anything to the contrary in this Agreement, as between the Parties, all Development and Commercialisation plans are the Confidential Information of the Licensee.
“Confidentiality Period” shall have the meaning set forth in Section 10.1.1.
“Control” or “Controlled” shall mean, with respect to any Know-How, Patents, Trademarks or other intellectual property rights, that a Party has the legal authority or right (whether by ownership, license, or otherwise) to grant a license, sublicense, access, or other right (as applicable) under such Know-How, Patents, Trademarks or other intellectual property rights to the other Party on the terms and conditions set forth herein, in each case (a) without breaching the terms of any agreement of such Party with any Third Party (including a Third Party which becomes any Acquisition Entity of Licensor) existing at the time such Party would be required hereunder to grant the other Party such license, sublicense, access, or other use right and (b) without being obligated to pay to any Third Party (including a Third Party which becomes any Acquisition Entity of Licensor) any royalties or other consideration therefor except for (i) any intellectual property right (including any Patents or Know-How) in-licensed by Licensor 

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under an Existing Upstream Agreement; and (ii) any intellectual property right (including any Patents or Know-How) in-licensed by Licensor under a New Upstream Agreement under which Licensee elects to take a sublicense and, where Licensee is obliged to reimburse associated In-Licensor Payments, Licensee agrees to reimburse the associated In-Licensor Payments pursuant to Section 2.7.3 which, in each case of (i) and (ii) shall be considered under the Control of Licensor.  Notwithstanding anything in this Agreement to the contrary, a Party will be deemed not to Control any intellectual property right (including any Patents or Know-How) that are owned or in-licensed by an Acquisition Entity, except (A) with respect to any intellectual property right (including any Patents or Know-How) arising out of or in connection with the conduct of activities under this Agreement after such Change of Control or acquisition (as applicable), (B) to the extent that any intellectual property right (including any Patents or Know-How) are included in or used in furtherance of the conduct of activities under this Agreement by the relevant Party, its Affiliates or such Acquisition Entity after such Change of Control or acquisition (as applicable), (C) for intellectual property rights (including any Patents or Know-How) constituting improvements (or improvements to such improvements) to the Licensed Technology in existence prior to such Change of Control or acquisition (as applicable) in each case, conceived by any employees or consultants of or otherwise by or on behalf of such Acquisition Entity; or (D) for intellectual property rights (including any Patents or Know-How) which comprise, include or were conceived, discovered, developed, reduced to practice or otherwise made using the Confidential Information of the other Party.
[***]
“Data Protection Laws” shall mean all applicable data protection, data security, data breach notification or privacy laws, rules, regulations, declarations, decrees, directive, legislative enactments, court orders, standards and other similar instruments, whether international, federal, state, or local, including but not limited to EU Data Protection Law, United States Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”), the California Consumer Privacy Act of 2018 (“CCPA”) and any supranational or national legislation relating to privacy and data protection, direct marketing or the interception or communication of electronic messages, in each case as amended, consolidated, re-enacted or replaced from time to time, and any relevant law, statute, declaration, decree, directive, legislative enactment, order, ordinance, regulation, rule or other binding instrument which implements, replaces, adds to, amends, extends, reconstitutes or consolidates such laws from time to time, in each case as amended, consolidated, re-enacted or replaced from time to time.
“Data Subject” shall mean a natural person who is an identified or identifiable natural person to whom the Personal Data relates.  An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. 
“Development” shall mean all drug development activities, including those related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, assay development, cell line development, formulation development, drug substance and drug product process development, product and process characterization, qualification and validation of processes and test methods, quality assurance/quality control, clinical studies, statistical analysis and report writing, the preparation, submission and prosecution of BLAs and MAAs, regulatory affairs with respect to the foregoing, and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval, including any post-marketing development commitments.  When used as a verb, “Develop” means to engage in Development.
“Development Budget” shall mean a budget agreed mutually by the Parties covering the Development of the Products in accordance with the Development Plan, which budget is split into (a) an annual development budget covering activities for a given calendar year and (b) a long term development 

5

budget covering successive [***] year periods, including a payment schedule for payments by Licensee to Licensor to reimburse Licensor for the conduct of the Existing Pivotal Trials and, as applicable, the Additional Compound Development Activities and the Additional ImmTOR Development Activities.
“Development Cost” shall mean, with respect to a Product, those costs and expenses incurred directly in connection with the performance of any Development activities for such Product in accordance with the applicable Development Plan and Development Budget, including [***]. 
“Development Milestone Event” shall have the meaning set forth in Section 6.2.1.
“Development Milestone Payment” shall have the meaning set forth in Section 6.2.1.
“Development Plan” shall mean a plan mutually agreed by the Parties covering the global Development of the Products, including the Additional Compound Development Activities and the Additional ImmTOR Development Activities, if any, and the Existing Pivotal Trials, and the strategy for, preparation and submission of Regulatory Filings and interactions with Regulatory Authorities for the Products, [***].  The Development Plan will specify which Party is to conduct a given activity.  [***].
“Dispute” shall have the meaning set forth in Section 17.2.1.
“DOJ” shall have the meaning set forth in Section 18.1.
“Drug Pricing Transparency Laws” shall have the meaning set forth in Section 11.1.
“EEA” shall mean the European Economic Area.
“Effective Date” shall mean (a) in the event that the Parties determine pursuant to Section 18 that HSR filings are required, the HSR Clearance Date, (b) in the event that the Parties determine prior to the Execution Date that no HSR filings are required, the Execution Date, or (c) in the event that the Parties determine after the Execution Date that no HSR filings are required, the date that is [***] days from the date the Parties make such mutual.
“EMA” shall mean the European Medicines Agency and any successor Governmental Authority having substantially the same function.
[***].
“Encumbrance” shall mean any lien, pledge, security interest, right of first refusal, option, title defect, Claim, license, restriction, or other interest or encumbrance of any kind or nature whatsoever, whether or not perfected, including any restriction on use, transfer, receipt of income or exercise of any other attribute of ownership.
“EU Data Protection Law” shall mean the GDPR and any relevant law, statute, declaration, decree, directive, legislative enactment, order, ordinance, regulation, rule or other binding instrument which implements, replaces, adds to, amends, extends, reconstitutes or consolidates such laws from time to time, in each case as amended, consolidated, re-enacted or replaced from time to time, including for clarity, the UK Data Protection Act 2018.
“Exclusive” shall mean in relation to a Party (subject to any retained rights set forth in this Agreement of the other Party), exclusive even as to the other Party and its Affiliates.
“Execution Date” shall have the meaning set forth in the introduction to this document.

6

“Executive Officer” shall mean for Licensor, its Chief Executive Officer, and for Licensee, its Chief Executive Officer or a direct report of its Chief Executive Officer, or, in each case, another senior executive officer who is a direct report to such Party’s Chief Executive Officer (but for each Party, other than an existing member of the JSC) with appropriate responsibilities, seniority, and decision making authority; provided that any of the foregoing individuals may designate the Chief Financial Officer as his/her designee for financial related matters.  In the event that the position of any of the Executive Officers identified in this definition no longer exists due to a Change of Control, corporate reorganization, corporate restructuring, or the like that results in the elimination of the identified position, then the applicable Party will replace the applicable Executive Officer with another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer prior to such Change of Control.
“Existing 212 Patents” shall mean that subset of the Licensed Patents that relate solely to SEL-212.  Existing 212 Patents existing as of the Execution Date are set forth in Annex A-2.
“Existing Pivotal Trials” shall mean Licensor’s current planned [***] Pivotal Clinical Trial [***] as included in the agreed Development Plan and Development Budget.
“Existing Upstream Agreements” shall mean [***] and any other license agreement pursuant to which Licensor Controls any Licensed Technology existing as of the Effective Date, including [***].
“Expedited Arbitration” shall have the meaning set forth in Section 17.2.7.
“Expedited Dispute” shall have the meaning set forth in Section 17.2.7.
“Exploit”, “Exploiting” or “Exploitation” shall mean to make, have made, import, use, sell or offer for sale, including to Develop, Commercialize, Manufacture, and have Manufactured.
[***].
“FDA” shall mean the U.S. Food and Drug Administration of the U.S. Department of Health and Human Services and any successor Governmental Authority having substantially the same function.
“FFDCA” shall mean the United States Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).
“Field” shall mean all diagnostic, prophylactic and therapeutic uses.
“Financial Transparency Laws” shall have the meaning set forth in Section 11.1.
“First Commercial Sale” shall mean, with respect to a Product, the date of the first commercial sale in a country by Licensee or any of its Affiliates or Sublicensees to a Third Party for end use or consumption of such Product approved by a Regulatory Authority in such country and, with respect to the European Union, separate pricing and reimbursement approval.  For clarity, First Commercial Sale does not include the supply or transfer of Product to an Affiliate or Sublicensee or for clinical trials or compassionate use.
“Force Majeure Event” shall mean any acts or events beyond a Party’s reasonable control, including strikes or other labor disturbances, lockouts, insurrections, riots, quarantines, epidemics, pandemics and other communicable disease outbreaks, government actions, acts of God, embargoes, wars, acts of war (whether war be declared or not), acts of terrorism, fires, earthquakes, floods or storms.
“FTC” shall have the meaning set forth in Section 18.1.

7

“FTE” shall mean one (1) person (or the equivalent of one (1) person) employed by Licensor or any of its Affiliates on a full time basis, which for the purposes hereof shall be one thousand eight hundred and eighty (1,880) hours per year, and assigned to perform work in connection with this Agreement.
“FTE Cost” shall mean the FTE Rate multiplied by the applicable number of FTEs who perform a specified activity pursuant to this Agreement.
“FTE Rate” shall mean the actual, documented fully burdened direct cost of the relevant FTE working full time for one (1) year in performing the relevant activity (comprising of such FTE’s salary, benefits, all Taxes related to such FTE, but excluding overtime payments to such employee unless otherwise agreed in writing in advance between the Parties) provided that, the FTE Rate for any FTE who devotes less than [***] hours per year in performing the relevant activity shall be determined on a pro rata basis based upon the actual number of hours spent divided by [***].
“Full Enrolment” shall mean, with respect to either Existing Pivotal Trials, the close of enrolment following completion of accrual of patients into such clinical study such that the inclusion of the protocol-defined number of patients into such clinical study has been successfully achieved.
“GAAP” shall mean generally accepted accounting principles as practiced in the United States, as consistently applied.
“GCP” shall mean the current standards for clinical studies for pharmaceuticals, as set forth in the ICH guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the FDA, EMA and other Regulatory Authorities in countries in which a Product is intended to be sold.
“GDPR” shall mean Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
“GLP” shall mean all applicable good laboratory practice standards, including, as applicable, (i) as set forth in the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and (ii) the equivalent applicable Law in any relevant country, each as may be amended and applicable from time to time. 
“Governmental Authority” shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities, agencies, commissions or bodies.
“Greater China” shall mean mainland China, Hong Kong, Macau and Taiwan.
“HSR Act” shall have the meaning set forth in Section 18.1.
“HSR Clearance Date” means the earlier of: (a) the date on which the FTC or DOJ shall notify the Parties of early termination of the waiting period under the HSR Act, or (b) the date on which the applicable waiting period under the HSR Act expires.
“ICH” shall mean the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and any successor council having substantially the same function.
“ImmTOR” shall mean: (a) the Licensor’s proprietary tolerogenic ImmTOR platform, also known as SEL-110, as further defined in Annex B, which acts to modulate the immune response to “compound” in humans by potentially inducing immune tolerance by encapsulating an immunomodulator rapamycin, and [***].

8

“ImmTOR Manufacturing Process” means the process for manufacturing ImmTOR described in IND 124184 for ImmTOR.
“ImmTOR Trademarks” shall mean the Trademark ImmTORTM and any other related Trademark or service mark containing the word “ImmTOR” and any other Trademark that Licensor or its Affiliates use on or with ImmTOR, for each of the foregoing that are Controlled by Licensor or its Affiliates.
“In-Licensor Payments” shall have the meaning set forth in Section 2.7.1.
“IND” shall mean any investigational new drug application, clinical trial application, clinical trial exemption, or similar or equivalent application filed with the applicable Regulatory Authority of a country of the Territory for approval to conduct clinical testing of a biological or pharmaceutical product in humans in such country.
“Indemnifying Party” shall have the meaning set forth in Section 14.3.2.
“Indemnitee” shall have the meaning set forth in Section 14.3.2.
“Indication” shall mean a separate and distinct disease, disorder, or medical condition for which a Product can be used to diagnose, treat, or prevent, which use is the subject of a separate BLA or MAA approval for a distinct labeling supported by data from at least one Pivotal Clinical Trial not previously submitted to the applicable Regulatory Authority.  For clarity, subpopulations or patients with a primary disease, disorder or condition, however stratified, shall not be deemed to be separate 
“Indications” for the purposes of this Agreement, including stratification by stages or progression (including precursor condition), particular combinations of symptoms associated with the primary disease, disorder or condition, prior treatment courses, response to prior treatment, different lines of treatment, family history, clinical history, phenotype, age (e.g. adult and pediatric) or other stratification.
“Insolvency Proceeding” shall mean any proceeding commenced by or against any Person under any provision of Title 11 of the United States Code (as in effect from time to time) or under any other state or federal bankruptcy or insolvency law, or proceedings seeking reorganization, arrangement, or other similar relief.
“JSC” shall have the meaning set forth in Section 3.1.1.
“Know-How” shall mean all commercial, technical, scientific, and other know-how and information, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, composition of matter, analytical reference standards, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing and quality control data and know how, including regulatory data, study designs, and protocols), and cells, cell lines, assays, animal models, and other physical, biological, or chemical materials, in all cases, whether or not confidential, proprietary, patentable, in written, electronic or any other form now known or hereafter developed, but excluding all Patents.
“Law” shall mean any federal, state, local or supranational law, statute or ordinance, or any rule, regulation, or published guidelines promulgated by any Governmental Authority or any similar provision having the force or effect of law, together with the requirements of any Governmental Authority.
“License” shall mean the licenses set forth in Section 2.1 of this Agreement.

9

“Licensed Know-How” shall mean (a) all Compound Know-How and (b) all Know-How Controlled by Licensor or its Affiliates (i) in existence as of immediately prior to the Effective Date or (ii) arising during the Term, [***]. 
“Licensed Patents” shall mean (a) all Compound Patents and (b) all Patents Controlled by Licensor or its Affiliates (i) in existence as of immediately prior to the Effective Date or (ii) arising during the Term, [***].  Licensed Patents existing as of the Execution Date are set forth in Annex A.
“Licensed Technology” shall mean (a) the Licensed Patents, and (b) the Licensed Know-How.
“Licensee” shall have the meaning set forth in the introduction to this document.
“Licensee CMO Agreement” shall have the meaning set forth in Section ‎‎13.4.1.
“Licensee Indemnitee” shall have the meaning set forth in Section 14.1.
“Licensor” shall have the meaning set forth in the introduction to this document.
“Licensor Acquisition” shall have the meaning set forth in Section 2.10.3.
“Licensor Acquisition Program” shall have the meaning set forth in Section 2.10.3.
“Licensor COC Program” shall have the meaning set forth in Section 2.10.2.
“Licensor Development Activities” shall mean the Existing Pivotal Trials and, if any, the Additional Compound Development Activities and the Additional ImmTOR Development Activities.
“Licensor Development Breach” shall have the meaning set forth in Section 4.3.1.
“Licensor Indemnitee” shall have the meaning set forth in Section 14.2.
“Licensor Permitted Activities” shall mean (a) the Exploitation of products other than the Products in the Field in the Territory; (b) the Exploitation of the Product outside the Field outside the Territory; and (c) the exercise of the Licensor Retained Rights.
“Licensor Retained Rights” shall have the meaning set forth in Section 2.5.
“Litigation Costs” shall have the meaning set forth in Section 14.1.
“Loss of Market Exclusivity” shall mean an event where or circumstances where, with respect to any Product in any country: (a) one or more Biosimilar Product(s) are being marketed in such country; [***].
“Losses” shall have the meaning set forth in Section 14.1.
“MAA” shall mean a Marketing Authorization Application or other application or submission submitted to the EMA, pursuant to the centralized approval procedure or, if such centralized approval procedure is not used, to the applicable Regulatory Authority of a country in the EU with respect to the mutual recognition, de-centralised or any other national approval, for approval to commercially sell a Product in that country or in that group of countries or equivalent foreign applications to a Regulatory Authority for approval to commercially sell a Product in any country or jurisdiction in the Territory other than an NDA or BLA.

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“Manufacture” and “Manufacturing” shall mean all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of Product, including process qualification and validation, scale-up, clinical and commercial manufacture, stability testing, quality assurance and quality control.
“Materials” shall have the meaning set forth in Section 2.8.4.
“Minimum Floor” shall have the meaning set forth in Section 6.5.4.
[***].
[***].
[***].
[***].
[***]. 
[***].
[***].
“New Upstream Agreement” shall have the meaning set forth in Section 2.7.3.
“Non-Acting Party” shall have the meaning set forth in Section 7.3.2.
[***]. 
“Order” means any order, judgment, injunction, award, decree, ruling, stipulation, determination, or writ of any Governmental Authority.
“Opted-In New Upstream Agreement” shall have the meaning set forth in Section 2.7.3.
“Other Joint New IP” shall have the meaning set forth in Section 9.2.2.
“Other Joint New IP Patents” shall mean any and all Patents claiming Other Joint New IP.
[***].
[***].
[***].
[***].
[***].
“Out of Pocket Costs” shall mean, with respect to certain activities for a Product hereunder, specifically identifiable direct expenses paid or payable by either Party or its Affiliates to Third Parties incurred to conduct such activities, including payments to contract personnel (including contractors, consultants, and subcontractors).
“Patent(s)” shall mean all patents and patent applications (including all provisional applications, priority applications, substitutions, divisionals, continuations, continuations in part), any patent issued 

11

with respect to any such patent applications, any reissue, reexamination, utility models or designs, renewal, or extension (including any patent term adjustment, patent term extension, supplemental protection certificate, or the equivalent thereof) of any such patent, any confirmation patent or registration patent or patent of addition based on any such patent, and any inventor’s certificates, and all equivalents and counterparts thereof in any country.
“Patent Challenge” shall have the meaning set forth in Section 16.4.
“Permitted Encumbrance” shall mean any (a) statutory Encumbrances for Taxes that are not yet due and payable or which are being contested in good faith through proper proceedings, in each case, with sufficient reserves maintained in accordance with GAAP; (b) statutory Encumbrances arising out of operation of Law with respect to a liability incurred in the ordinary course of business with respect to any amounts not yet due and payable; (c) Encumbrances, other than liens securing indebtedness for borrowed money, that, individually and in the aggregate, (i) do not and would not reasonably be expected to detract from the value or impair the Exploitation of the Product and (ii) do not conflict with any rights granted to Licensee and its Affiliates and Sublicensees hereunder; (d) mechanics’, materialmens’, carriers’, workmens’, warehousemens’, repairmens’, landlords’ or other like Encumbrances and security obligations incurred in the ordinary course of business with respect to any amounts not yet due and payable; and (d) Encumbrances created or required by this Agreement in favor of Licensee and its Affiliates and Sublicensees.
“Person” shall mean any individual, corporation, partnership, limited liability company, association, joint venture, trust or any other entity or organization, including any Governmental Authority.
“Personal Data” shall mean any information regulated by any applicable Data Protection Laws, including any information relating to an identifiable Data Subject.
“Personal Data Breach” shall mean a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, Personal Data which has been transferred by one Party to the other Party, whether by physical or electronic means, pursuant to this Agreement (if any). 
“Phase I Clinical Trial” shall mean, as to the Product, a study in humans of the metabolism, tolerability and safety of such Product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase II Clinical Trial of such Product, as further defined in Federal Regulation 21 C.F.R. 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.  A Phase I Clinical Trial shall be deemed initiated upon the dosing of the first subject.
“Phase II Clinical Trial” shall mean, as to the Product, a study, conducted in diseased humans, of the feasibility, safety, dose ranging and efficacy of such Product, that is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Product, as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.  For the avoidance of doubt, a Phase II Clinical Trial requires enrollment of patients with the applicable disease or condition and is aimed to provide a measure of efficacy in addition to short-term tolerability.  A Phase II Clinical Trial shall be deemed initiated upon the dosing of the first patient. 
“Phase III Clinical Trial” shall mean, as to the Product, a study in humans performed to gain evidence of the efficacy of such Product in a target population, and to obtain expanded evidence of safety for such Product that is needed to evaluate the overall benefit-risk relationship of such Product and provide an adequate basis for physician labeling, as described in 21 C.F.R. 312.21(c), as amended from time to 

12

time, or the corresponding regulation in jurisdictions other than the United States.  A Phase III Clinical Trial shall be deemed initiated upon the dosing of the first patient.
“PHSA” shall mean the United States Public Health Services Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).
“Pivotal Clinical Trial” shall mean adequate and well-controlled clinical trials (as defined in 21 C.F.R. § 314.126, as amended from time to time, or corresponding regulations in jurisdictions other than the United States) that are designed to demonstrate the effectiveness of a Product in certain Indications and are intended to form the primary basis for a Regulatory Filing seeking Regulatory Approval, including clinical trials which prove substantial evidence of effectiveness and have the ability to generate product labelling that defines an appropriate patient population and provides adequate information to enable safe and effective use of the Product, regardless of whether such trials are captioned as a Phase II Clinical Trial, Phase IIb Clinical Trial, Phase II/III Clinical Trial or Phase III Clinical Trial, but excluding a Phase I Clinical Trial. 
“Proceeding” shall mean any action, arbitration, audit (to the knowledge of such Party), hearing, investigation (to the knowledge of such Party), litigation or suit (whether civil, criminal, administrative, investigative or informal) commenced, brought, conducted or heard by or before, or otherwise involving any Governmental Authority or arbitrator. 
“Processing” and “Process” shall mean any operation or set of operations that is performed on Personal Data or on sets of Personal Data, whether or not by automated means, such as collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.
“Products” shall mean (a) SEL-212, (b) any pharmaceutical composition containing a combination of the Compound with ImmTOR, whether or not such combination is the sole active ingredient or biologic, and (c) all forms, presentations, formulations and dosage forms of the product or compositions of clause (a) and (b) respectively.  For clarity, a Product includes any Combination Product.
“Proposal” shall have the meaning set forth in Section 17.2.7(b).
“Prosecution” or “Prosecute” shall have the meaning set forth in Section 9.3.1(a).
“Quality Agreements” shall mean the agreements between the Parties on standard terms and conditions for the pharmaceutical industry which outlines the operational responsibilities of each Party with respect to quality assurance and quality control of the Compound, ImmTOR and/or Products supplied under this Agreement.
“Regulatory Approval” shall mean all approvals by Regulatory Authorities necessary for the Exploitation of a pharmaceutical or biologic product for one or more Indications in a country or regulatory jurisdiction (including pricing and reimbursement approvals).
“Regulatory Authority” shall mean any Governmental Authority involved in granting Regulatory Approvals in the applicable country in the Territory, including the FDA in the United States, the EMA and the European Commission in the European Union, and the Japanese Ministry of Health, Labour, and Welfare and the Pharmaceuticals and Medical Devices Agency in Japan.
“Regulatory Exclusivity Period” shall mean, with respect to each Product in any country in the Territory, any period of data, market or other regulatory exclusivity (other than Patent exclusivity) granted or afforded by Law or by a Regulatory Authority in such country that confers exclusive marketing rights 

13

with respect to such Product in such country or prevents another party from using or otherwise relying on any data supporting the approval of a BLA or MAA or supporting the Regulatory Approval for such Product without the prior written consent of the BLA-holder, MAA-holder or Regulatory Approval-holder, as applicable, such as reference product exclusivity for biological products under Section 351(k)(7) of the PHSA, new chemical entity exclusivity, new use or Indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent related pediatric exclusivity or any other applicable marketing or data exclusivity, including any such periods listed in the FDA’s Orange Book or Purple Book or any such periods under national implementations in the EU of Article 10 of Directive 2001/83/EC, Article 14(11) of Parliament and Council Regulation (EC) No. 726/2004, Parliament and Council Regulation (EC) No. 141/2000 on orphan medicines, Parliament and Council Regulation (EC) No. 1901/2006 on medicinal products for pediatric use and all international equivalents of any of the foregoing.
“Regulatory Filing” shall mean any filing, application or submission with a Regulatory Authority relating to or to permit or request, as applicable, the clinical evaluation or Regulatory Approval of a pharmaceutical or biologic product in a particular country or jurisdiction.  Regulatory Filings include without limitation INDs, BLAs and MAAs.
“Regulatory Materials” shall mean any and all regulatory applications, submissions, notifications, communications, correspondences, registrations, and other filings made to, received from, or otherwise conducted with a Regulatory Authority in order to or in connection the Exploitation of a pharmaceutical or biologic product in a particular country or jurisdiction, including all Regulatory Filings and Regulatory Approvals.
[***].
[***].
[***].
“Royalty” shall have the meaning set forth in Section 6.4.1.
“Royalty Reporting Quarter” shall have the meaning set forth in Section 6.6.1.
“Royalty Term” shall mean, on a Product-by-Product and country-by-country basis, the period starting on the First Commercial Sale of such Product in such country and ending on the later to occur of: (a) [***] years from the First Commercial Sale of such Product in such country; (b) the expiration of the last-to-expire Valid Claim of a Licensed Patent covering such Product in such country; and (c) the expiry of all Regulatory Exclusivity Periods for such Product in such country. 
“Safety Agreement” shall mean the agreement between the Parties relating to the sharing of safety data Controlled by each Party and its Affiliates related to the Compound, ImmTOR and / or the Products.
“Sales Milestone Event” shall have the meaning set forth in Section 6.3.1.
“Sales Milestone Payment” shall have the meaning set forth in Section 6.3.1.
“Second Source Supplier” shall have the meaning set forth in Section ‎‎13.4.1.
“Securitization Transaction” shall have the meaning set forth in Section 19.5.2.
“SEL-212” shall mean Licensor’s proprietary SEL-212 product described on Annex B.
[***]. 

14

“Selecta-Controlled Patents” shall mean that subset of the Licensed Patents that exist as of the Execution Date and are Controlled by Selecta [***].
“Significant Trial” means, with respect to the Product, a new human clinical trial that, at the time of commencement, is reasonably expected to (a) cost in excess of [***] and / or (b) involve the enrollment of more than [***] patients.
“Specifications” shall mean the Manufacturing specifications set forth in the Regulatory Approvals for the Products, together with mutually agreed specifications set forth in the Quality Agreement for the Product.
“Sublicense” shall have the meaning set forth in Section 2.3.
“Sublicensee” shall mean any person or entity other than an Affiliate of Licensee that is granted a Sublicense by Licensee.
“Supply Agreement” shall mean the agreement relating to the supply of Product by or on behalf of Licensor to Licensee or its Affiliates or Sublicensees entered into by the Parties pursuant to Section 13.2.
“Supply Price” shall mean, as applicable, the fully allocated cost of manufacturing nude vials of the Product, as calculated in accordance with GAAP, including costs incurred by Licensor to obtain active ingredients, raw materials, components, containers and labeling and the direct costs of production, packaging, analytical and stability testing, quality control and quality assurance, reasonable supervision, reasonable material variance, reasonable yield variance, reasonable investigations, serialisation as required by applicable Law, but excluding any mark-up or overhead. For clarity, where Licensor acquires any of the foregoing from any of its Affiliates, the Supply Price shall include the fully allocated cost of such Affiliate and not the purchase price applied between companies.  [***], unless the actual cost of Manufacturing the same decreases during such period, in which case the Supply Price for such period will be the actual cost of Manufacturing.  For clarity, the Supply Price does not include any allocation of royalty or other amounts payable to Licensor’s licensors.
“Tax Action” shall have the meaning set forth in Section 7.3.2.
“Taxes” shall mean all taxes of any kind, and all charges, fees, customs, levies, duties, imposts, required deposits or other assessments, including all federal, state, local or foreign net income, capital gains, gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social security, worker’s compensation, unemployment, occupation, capital stock, transfer, gains, windfall profits, net worth, asset, transaction and other taxes, and any interest, penalties or additions to tax with respect thereto, imposed upon any Person by any Governmental Authority under applicable Laws, whether disputed or not. 
“Technology Transfer” shall have the meaning set forth in Section ‎‎13.4.6.
“Term” shall have the meaning set forth in Section 16.1.
“Territory” shall mean, subject to Section 2.2.11, all countries of the world, excluding Greater China.
“Third Countries” shall mean all countries outside of the scope of the data protection laws of the EEA, excluding countries approved as providing adequate protection for Personal Data by the European Commission from time to time, which at the date of this Agreement include Andorra, Argentina, Canada, Faroe Islands, Guernsey, Isle of Man, Israel, Japan, Jersey, New Zealand, Switzerland and Uruguay.
“Third Party” shall mean any Person other than Licensor, Licensee, or their respective Affiliates.

15

“Third Party Infringement Claim” shall have the meaning set forth in Section 9.5.1.
“Third Party Payments” shall mean the aggregate of all payments (including for royalties, lump sum payments, upfront payments, costs, damages, judgements and awards) which Licensee, its Affiliates or its Sublicensees pay to a Third Party (including any Third Party which later becomes an Acquisition Entity of Licensor but excluding any Sublicensee) for a license under Patents or Know-How owned or controlled by such Third Party (including any Acquisition Entity of Licensor) that are reasonably necessary or reasonably useful for the Exploitation of the Products in the Field in the Territory.
“Trademark” shall mean any trademark, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan, or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing, whether registered or unregistered.
“Transferred Data” shall mean the Personal Data transferred by one Party to the other Party, whether by physical or electronic means, pursuant to this Agreement (if any) in respect of which EU Data Protection Law applies.
[***].
“Transparency Laws” shall have the meaning set forth in Section 11.1.
“United States” or “U.S.” shall mean the United States of America and its territories, commonwealths, possessions (including the District of Columbia and the Commonwealth of Puerto Rico) and its military bases.
“Up-Front Payment” shall have the meaning set forth in Section 6.1.
“Upstream Agreements” shall mean, collectively, the Existing Upstream Agreements and the Opted-In New Upstream Agreements.
“Valid Claim” shall mean: (a) any claim of an issued and unexpired Patent, that shall not have been withdrawn, lapsed, abandoned, revoked, canceled or disclaimed, or held invalid or unenforceable by a court, Governmental Authority, national or regional patent office or other appropriate body that has competent jurisdiction in a decision being final and unappealable or unappealed within the time allowed for appeal; and (b) a claim of a pending patent application that is filed and being prosecuted in good faith and that has not been finally abandoned or finally rejected and which has been pending for no more than [***] years from the date of filing of the earliest patent application to which such pending patent application claims priority. (For clarity, a claim of an issued patent that ceased to be a Valid Claim before it issued because it had been pending for more than [***] years from the date of filing of the earliest patent application to which such pending patent application claims priority, but subsequently issued and is otherwise described by clause (a) of the foregoing sentence shall again be considered to be a Valid Claim once it issues. The same principle shall apply in similar circumstances such as if, for example (but without limitation), a final rejection of a claim is overcome). 
“Withholding Taxes” shall have the meaning set forth in Section 7.3.1.

1.2    Interpretation.  Unless the context of this Agreement otherwise requires: (a) words of any gender include each other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms “hereof,” “herein,” “hereby,” and derivative or similar towards refer to this entire Agreement and not merely to the particular provision in which such words appear; (d) the terms “Section” or “Annex” refer to the specified Section or Annex of this Agreement; (e) the term “or” has, except where otherwise indicated, the inclusive meaning represented by the phrase, “and/or”; (f) the term “including” means “including, without limitation”; (g) the word “shall” will be construed to have the same meaning and effect as the word “will”; (h) any definition of 

16

or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein); (i) any reference herein to any Person will be construed to include the Person’s successors and assigns; (j) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement; (k) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging); (l) references to any specific law, rule or regulation, or article, section or other division thereof, will be deemed to include the then current amendments thereto or any replacement or successor law, rule or regulation thereof, (m) “days” refers to calendar days; and (n) the Annexes form part of the operative provisions of this Agreement and references to this Agreement shall include references to the Annexes.  All accounting terms used but not otherwise defined herein shall have the meanings ascribed to such terms under the Accounting Standards.  All references to “$” amounts hereunder shall be deemed to be U.S. Dollars. 

2.    GRANT OF RIGHTS; NON-COMPETE

2.1    License Grant.  
2.1.1    Subject to the terms and conditions of this Agreement (including Section 2.5), Licensor hereby grants to Licensee an Exclusive, sublicensable (in accordance with Section 2.3) and assignable (in accordance with Section 19.5) license under the Licensed Technology to Exploit the Products in the Field in the Territory (the “License”).  Upon the expiration of the Royalty Term for a Product in a country of the Territory, the foregoing license shall be rendered fully paid-up, royalty-free and non-terminable for such Product in such country.

2.2    Additional Obligation of Licensor. Licensor:
2.2.1    shall, as soon as reasonably practicable, and in any event no later than the [***] calendar day, following receipt of notice from Licensee requesting the same, [***];
2.2.2    shall [***] not materially breach or be in material default under any of its obligations under any Upstream Agreement or take any other action, or omit or fail to take any action (including making necessary payments unless such payment breach or default is the result of Licensee failing to reimburse In-Licensor Payments in accordance with Section 2.7.3), which might reasonably be expected to result in an early termination of any Upstream Agreement or otherwise have an adverse effect in any material respect on the rights of Licensee hereunder;
2.2.3    [***] shall immediately (and in any event within [***] Business Days) notify Licensee if Licensor receives notice (whether written or otherwise) from 3SBio alleging that Licensor is in breach of its obligations under the 3SBio License Agreement and shall promptly take all reasonable steps to remedy such breach, unless and to the extent such breach is caused by Licensee’s failure to comply with its obligations under this Agreement, in which case Licensor shall promptly notify Licensee of such alleged Licensee breach in reasonable detail;
2.2.4    shall [***] not terminate any Upstream Agreement in a manner that would terminate or have an adverse effect on the rights of Licensee hereunder;
2.2.5    shall [***] promptly notify Licensee upon Licensor becoming aware of any alleged, threatened or actual breach of an Upstream Agreement (other than the 3SBio License Agreement which is the subject of Section 2.2.3) by Licensor where termination of such Upstream Agreement is 

17

being or reasonably could be sought by the counterparty and such termination would terminate or have an adverse effect on the rights of Licensee hereunder;
2.2.6    shall [***] use Commercially Reasonable Efforts to enforce the terms of [***] the Upstream Agreements (other than the 3SBio License Agreement which is the subject of Section 2.2.3) in the case of a breach by any counterparty to such agreements, and shall keep Licensee reasonably informed in connection therewith, including providing prompt notice of any breach by the counterparty thereto; 
2.2.7    subject to Section 2.2.14, shall, in respect of the 3SBio License Agreement, provide Licensee with reasonable notice, information and opportunity to comment regarding any decisions to be taken by the joint steering committee constituted pursuant to that agreement which could have an adverse effect on the rights of Licensee hereunder [***];
2.2.8    shall [***], not agree, consent or acquiesce to any amendment, supplement or other modification to the Upstream Agreements that would reasonably be expected to have an adverse effect on the rights or expand the obligations of Licensee under this Agreement, unless and until Licensee has consented in writing to the same (such consent, not to be unreasonably withheld, conditioned or delayed);
2.2.9    shall [***] not assign, novate or otherwise transfer [***] any Upstream Agreement, to a Third Party without Licensee’s consent if such assignment, novation or other transfer would have an adverse effect on the rights of Licensee hereunder, except in connection with a permitted assignment of this Agreement in accordance with Section 19.5;
2.2.10    shall, during the Term, [***];
2.2.11    [***]
2.2.12    shall, as soon as reasonably practicable and in any event no later than the [***] calendar day following the Effective Date, commence discussions with 3SBio, and shall use Commercially Reasonable Efforts until the first anniversary of the Effective Date, to:
(a)    obtain 3SBio’s agreement as soon as reasonably practicable (and, upon Licensee’s request, to facilitate direct discussion between Licensee and 3SBio [***]; and
(b)    [***];
2.2.13    if a Party reasonably believes that 3SBio is in breach of its obligations under the 3SBio License Agreement, such Party shall promptly notify the other in writing, providing reasonable details of such breach (a “3SBio Breach Notice”).  Upon receiving Licensee’s 3SBio Breach Notice or upon Licensee’s request following Licensee’s receipt of Licensor’s 3SBio Breach Notice, Licensor (a) shall promptly notify 3SBio of such breach and use Commercially Reasonable Efforts to promptly enforce the terms of the 3SBio License Agreement and to have 3SBio cure such breach, (b) shall, upon Licensee’s request, promptly facilitate direct discussion between Licensee and 3SBio to have 3SBio cure such breach, and (c) if 3SBio refuses to cure such breach, fails to cure such breach within the time period specified under Section 12.2 of the 3SBio License Agreement or fails to cure such breach to the reasonable satisfaction of Licensee, then, if so requested by Licensee, with Licensee bearing Licensor’s out of pocket costs associated therewith (provided Licensor shall provide Licensee with monthly updates regarding legal fees accrued to date and estimates of legal fees to completion), (i) shall promptly bring, and shall use Commercially Reasonable Efforts to pursue, an action against 3SBio to enforce the terms of the 3SBio License Agreement using counsel chosen by Licensee and allowing Licensee to decide and direct the enforcement strategy for such action with Licensor implementing such strategy, and (ii) shall keep Licensee informed and provide copies of all communications of all developments in connection with any 

18

such action, and shall implement any changes to the strategy Licensee has instructed Licensor to take for such action. 
2.2.14    Without limiting Licensor’s obligations under Section 2.2.13, if:
(a)    [***]; and
(b)    
(i)    Licensee has provided Licensor with a 3SBio Breach Notice regarding the 3SBio License Agreement and 3SBio has not remedied the relevant breach within [***] Business Days following the date of Licensor’s notice delivered in accordance with Section 2.2.13 (a); or
(ii)    Licensor has received notice (whether written or otherwise) from 3SBio alleging that Licensor is in breach of its material obligations under the 3SBio License Agreement and Licensor has not remedied the same within [***] Business Days (in the case of a failure to make payment) or [***] Business Days (in the case of any other breach), in each case, of Licensor’s receipt of such notice, provided that such breach is not caused by Licensee’s failure to comply with its obligations hereunder,
[***].

2.3    Right to Sublicense.  Licensee shall have the right to grant sublicenses (or licenses, or further rights of reference, as applicable), [***], under the License (individually, a “Sublicense”) to its Affiliates and Third Parties [***], [***].

2.4    Disclosure of Licensed Know-How.  Promptly following the Effective Date (or as otherwise requested by Licensee) and for no additional consideration, Licensor shall promptly disclose to Licensee, or provide Licensee with copies (both in print and, where available, electronic copies) of the Licensed Know-How relating to the Compound and / or SEL-212 [***] existing as of the date of such transfer in reasonably sufficient detail in order for a reasonably-skilled person to practice such Licensed Know-How solely within the scope of the License.  Licensor shall update such Licensed Know-How previously transferred to Licensee on as frequent and regular a basis as is reasonably required by Licensee.  Without limiting the foregoing, such transfer of such Licensed Know-How shall include:
2.4.1    transfer of copies of the results of and data from all clinical trials and pre-clinical studies (including the Existing Pivotal Trials, when the same have been completed) conducted prior to and as of the Effective Date relating to the Compound and /or the SEL-212 (including all clinical data, pre-clinical data, hard-copy case report forms and reports to the extent disclosure thereof to Licensee is not prohibited by applicable Laws outside the Territory);
2.4.2    transfer of copies of the data and results of all CMC Activities relating to the Compound and /or SEL-212 [***];
2.4.3    transfer copies of all Development reports and summaries relating to the Compound and/or SEL-212 [***]; and
2.4.4    transfer of copies of all documents supporting technical transfer received from a Third Party manufacturer or development of Compound of Licensor or its Affiliates;
2.4.5    providing Licensee with reasonable access to Licensor personnel with relevant expertise to explain such Licensed Know-How transferred hereunder.

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For clarity, in no event shall any transfer of Licensed Know-How to Licensee pursuant to this Section 2.4 include Licensed Know-How related solely to the Manufacture of ImmTOR. 

2.5    Reservation of Rights.  Notwithstanding anything in this Agreement to the contrary, Licensor shall, as between the Parties, retain for itself (and its Affiliates and (sub)licensees) the right under the Licensed Technology, with the right to grant licenses through multiple tiers, to:
2.5.1    Manufacture and supply the Products [***] for the Licensee, its Affiliates and its Sublicensees pursuant to Section 13;
2.5.2    Manufacture and supply the Products [***] for the purposes of conducting the Licensor Development Activities; and
2.5.3    conduct and perform the Licensor Development Activities in accordance with Section 4.3.
(collectively, the foregoing, the “Licensor Retained Rights”).

2.6    Combination Products.  Notwithstanding any other provision of this Agreement, for purposes of the License with respect to any Product that is a Combination Product, such License will not include any claims in any Licensed Patents which specifically claim only the additional active ingredient or biologic (i.e. the additional active ingredient or biologic which is not the Compound) but will include any claims in any Licensed Patents which include within their scope the combination of such additional active ingredient agent or biologic with the Compound or with the Compound and ImmTOR.

2.7    Upstream Agreements.
2.7.1    Subject to Section 2.7.2, Licensor agrees that all upfront, milestone, royalty, and other payments to any Third Party (including to any Third Party which becomes any Acquisition Entity of Licensor and including in relation to any sales by Licensee, its Affiliates or Sublicensees) (collectively, “In-Licensor Payments”) with respect to any Existing Upstream Agreements [***] will be the sole responsibility of Licensor.
2.7.2    Licensee agrees that, [***].
2.7.3    In the event that, after the Effective Date, Licensor in-licenses Licensed Technology that would be deemed Controlled for purposes of the License but for Licensor owing In-Licensor Payments under the agreement for such in-licensed Licensed Technology (each such agreement, a “New Upstream Agreement”) on account of any sublicense granted thereunder to Licensee or its Affiliates or its Sublicensees, Licensor will notify Licensee of the existence of and anticipated amounts of such In-Licensor Payments attributable to the Product (based on Licensee’s, its Affiliates’ and its Sublicensees’ pro rata share of the total amount thereof) and Licensee will have the right to decline a sublicense to such in-licensed Licensed Technology or take such sublicense (a New Upstream Agreement for which Licensee elects a sublicense, an “Opted-In New Upstream Agreement”), in which case Licensee agrees to comply with any obligations under such Opted-In New Upstream Agreement that apply to Licensee, its Affiliates and its Sublicensees and of which Licensee is informed by Licensor and to reimburse Licensor for such In-Licensor Payments.  In the event Licensee elects to take such sublicense and is required to reimburse Licensor for In-Licensor Payments thereunder, Licensee will make such payments to Licensor within [***] days of receiving an invoice from Licensor for the same and shall be entitled to offset such payments against the royalties otherwise due under Section 6.4 as a “Third Party Payment” in accordance with Section 6.5.3.
2.7.4    [***].

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2.7.5    Licensee shall be free, without the consent of the JSC or the Licensor, at any time during the Term, to obtain licenses to Third Party intellectual property rights.

2.8    ImmTOR Trademarks License.
2.8.1    Licensor hereby grants to Licensee an Exclusive, sublicensable (in accordance with Section 2.3) and assignable (in accordance with Section 19.5) license under the ImmTOR Trademarks in the Field and Territory solely in connection with the Commercialization of the Product.  The foregoing license shall be rendered non-terminable upon the expiration of the Royalty Term.  For clarity, nothing in this Section 2.8.1 shall prevent Licensor from using or licensing to a Third Party the ImmTOR Trademarks for use in relation to the Commercialization of a product in the Field in the Territory other than a Product.
2.8.2    Licensee acknowledges the validity of Licensor’s right, title and interest in and to the ImmTOR Trademarks.  Licensee shall not have, assert or acquire any right, title or interest in or to any of the ImmTOR Trademarks or the goodwill pertaining thereto, except as otherwise explicitly provided in this Agreement, and Licensee’s use of the ImmTOR Trademarks shall inure to the benefit of Licensor for the purpose of the ImmTOR Trademarks and trade name ownership, registration, enforcement, and maintenance.
2.8.3    Licensee shall, and shall cause its Affiliates and Sublicensees to, include all notices, markings and legends as are or may be required by applicable Laws in order to give appropriate notice of ownership of and rights to the ImmTOR Trademarks.  Licensee shall, and shall cause its Affiliates and Sublicensees to, use the ImmTOR Trademarks in accordance with all applicable federal, state and local Laws and with Licensor’s reasonable trademark usage policies and guidelines which may be in effect from time to time as provided to Licensee by Licensor in writing.
2.8.4    Upon Licensor’s reasonable request, Licensee shall provide, and shall cause its Affiliates and Sublicensees to provide, Licensor with representative samples of any materials bearing the ImmTOR Trademarks, including business forms, marketing materials, and advertising materials (“Materials”).  In the event that Licensor notifies Licensee within [***] Business Days of receipt of such Materials that, in the reasonable opinion of Licensor, such Materials materially deviate from the standards of quality set forth in Section 2.8.3, Licensee shall use Commercially Reasonable Efforts to correct such deviations.
2.8.5    Licensee shall not (a) challenge the validity of Licensor’s ownership of the ImmTOR Trademarks or any registration or application for registration thereof, or (b) seek its own registration of the ImmTOR Trademarks, or any name or mark confusingly similar to, or dilutive of, the ImmTOR Trademarks.
2.8.6    Licensee shall notify Licensor in writing, as promptly as practicable, should it become aware of activity by a Third Party that constitutes an unauthorized use, infringement, or dilution of any of the ImmTOR Trademarks.  Licensor shall have the sole right to take, and to determine whether or not to take, [***], any action(s) it deems appropriate with respect to any unauthorized use, infringement, or dilution of the ImmTOR Trademarks, and Licensee shall, at [***], cooperate with Licensor in connection with any such action.  [***] retain all recovery in the form of monetary damages or settlement from any such action.

2.9    No Other Rights.  Except as otherwise expressly provided in this Agreement, under no circumstances will a Party or any of its Affiliates, as a result of this Agreement, obtain any ownership interest, license or other right (whether by implication, estoppel or otherwise) in or to any Know-How, Patents or other intellectual property rights of the other Party or any of such other Party’s Affiliates, including tangible or intangible items owned, controlled or developed by the other Party or any of such 

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other Party’s Affiliates, or provided by the other Party or any of its Affiliates to the receiving Party or any of its Affiliates at any time, pursuant to this Agreement.  Neither Party nor any of its Affiliates will use or practice any Know-How or Patents licensed or provided to such Party or any of its Affiliates outside the scope of or otherwise not in compliance with the rights and licenses granted to such Party and its Affiliates under this Agreement.

2.10    Non-Compete.
2.10.1    During the Term, neither Licensor nor any of its Affiliates shall, directly or indirectly, [***]
2.10.2    [***]
2.10.3    [***]

2.11    [***].  [***].  Each of the Parties hereto recognizes that the restrictions contained in, and the terms of, this Section 2.11 are required for the protection of Licensor’s Royalties hereunder, and agree that if any provision in this Section 2.11 is determined by any court to be unenforceable by reason of its extending for too great a period of time or over too great a geographic area, or by reason of its being too extensive in any other respect, such covenant shall be interpreted to extend only for the longest period of time and over the greatest geographic area, and to otherwise have the broadest application as shall be enforceable under applicable Law.

3.    GOVERNANCE

3.1    Joint Steering Committee
3.1.1    General.  Within [***] days after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”), composed of an equal number of representatives of each Party including at least two (2) senior representatives of each Party.  The JSC may, from time to time, elect to establish sub-committees to perform its functions.  Each Party may replace its JSC representatives at any time upon prior written notice to the other Party.  Licensee shall have the right to designate the chairperson of the JSC.  The JSC shall have the right to set up subcommittees as required, comprised of equal numbers of appropriate representatives from each Party which shall not be voting committees.
3.1.2    Responsibility.  The JSC will have the following responsibilities:
(a)    review and discuss the initial Development Plan and Development Budget, and determine whether to approve the portions of each of such Development Plan and Development Budget that relate to the Licensor Development Activities;
(b)    review and discuss any amendments or updates to the Development Plan and Development Budget (in each case, whether initial or subsequent versions), and determine whether to approve any amendments or updates to the portions of each of such Development Plan and Development Budget that relate to the Licensor Development Activities (including whether to include any Additional Compound Development Activities or Additional ImmTOR Development Activities, and any changes to the protocols for (including any endpoints) and whether to terminate, disband or otherwise discontinue, any of the Existing Pivotal Trials);
(c)    supervise Licensor’s conduct of the Existing Pivotal Trials and determine whether there has occurred a Licensor Development Breach and whether to transfer the conduct of the Existing Pivotal Trials to Licensee pursuant to a Licensor Development Breach as permitted pursuant to Section 4.3.1;

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(d)    review and determine whether to approve Licensee’s reimbursement of Licensor for amounts incurred in excess of the payment schedule and budget set out in the Development Budget for any of the Additional Compound Development Activities and the Existing Pivotal Trials pursuant to Section 4.2.2;
(e)    review and determine whether to approve Licensor bearing Development Costs in excess of those set out in the Development Budget for any of the Additional ImmTOR Development Activities pursuant to Section 4.2.3;
(f)    oversee and review the Development of the Products and provide a forum for Licensee to share information on the Development activities for the Products performed by Licensee, its Affiliates or its Sublicensees;
(g)    provide a forum for Licensor to share information on the performance of the Licensor Development Activities;
(h)    provide a forum to facilitate Licensee sharing information on the overall strategy regarding Regulatory Approval of the Products in the Territory and, more specifically, the supporting, obtaining and maintaining Regulatory Approvals for the Products in the Territory;
(i)    provide a forum for Licensee to share information on the Commercialization activities for the Products in the Territory performed by Licensee, its Affiliates or its Sublicensees;
(j)    facilitate the Licensed Know-How transfer contemplated under Section 2.4 and any additional transfers by Licensor to Licensee of Licensed Know-How pursuant to Section 2.4;
(k)    facilitate the Know-How transfer to the Second Source Supplier contemplated under Section 13.4.6; 
(l)    review, discuss and determine whether to approve Licensor’s right to step-in under Section 9.4.2(c) to bring an action to abate a Competitive Infringement where Licensee has not;
(m)    review, discuss and determine whether to approve  a Second Source Supplier as contemplated under Section 13.4.1; and
(n)    provide a forum for the Parties to share information on patent prosecution matters and other intellectual property matters, and to facilitate coordination between the Parties in accordance with Section 9.
3.1.3    Meetings.  Unless otherwise agreed between the Parties, the JSC shall meet in person or via teleconference or video link at least quarterly until all payments under Section 6.2 have been paid and thereafter at least annually, on such dates and at such times and places as agreed to by the JSC representatives.  The first JSC meeting shall be held within [***] days of the Effective Date.  The JSC shall be disbanded, on Licensee’s election, upon a Change of Control of Licensor, provided that, if Licensor is performing Licensor Development Activities at such time, the JSC will be disbanded after the completion of such activities unless Licensee instructs Licensor to terminate such activities early, in which case, Licensor, at Licensee’s cost, shall promptly handover responsibility for, sponsorship of (to the extent relevant) and the conduct of the same to Licensee (or its nominated Affiliate or Third Party) in a smooth, efficient and timely manner.  Each Party’s advisors may be permitted to attend meetings of the JSC as the JSC determines as non-voting representatives of such Party, subject to such advisors agreeing to keep confidential the subject matter of, and any Confidential Information disclosed by the 

23

other Party at, such meeting.  Each Party shall be responsible for its own expenses for participating in the JSC.  Meetings of the JSC shall be effective only if at least [***] of each Party is present or participating.  The JSC chairperson may also call a special meeting of the JSC (in person or via teleconference or video link) if the JSC chairperson reasonably believes that a significant matter must be addressed prior to the next scheduled meeting of the JSC.  The JSC chairperson shall be responsible for (a) preparing and circulating an agenda for each meeting, and (b) appointing a secretary for such meeting from one of the attendees of such meeting who shall be responsible for the preparation and circulation of minutes of the meeting within [***] Business Days after each JSC meeting, and endeavoring to finalize such minutes within [***] days after each JSC meeting.

3.2    Decision Making.  The JSC shall serve as a decision-making and dispute resolution body solely with respect to the matters set forth in Sections [***], and decisions relating thereto shall be made by consensus.  If the JSC cannot reach a consensus decision on any of the foregoing matters, either Party may instruct the JSC to refer such matter to the Executive Officers for resolution.  If any such Party does so, then each Party will submit in writing its respective position to each of the Executive Officers.  Such Executive Officers will use good faith efforts to resolve such matter within [***] Business days after the JSC’s submission of such matter to such Executive Officers, which good faith efforts will include at least one (1) meeting between such Executive Officers.  If the Executive Officers are unable to reach unanimous agreement on any such matter within such [***] Business Day period, then:
3.2.1    if the matter relates to [***] then the matter will be decided by Licensee, [***]; 
3.2.2    if the matter relates solely to [***], then the matter will be decided by Licensor, [***];
3.2.3    if the matter relates to [***], then the matter will be decided by Licensee;
3.2.4    if the matter relates to [***], then the Executive Officers or their designees will submit their respective positions on such matter to be resolved by Expedited Arbitration, provided however that if Licensee agrees to pay the excess costs associated with Licensee’s position in relation to such matter, then the matter will be decided by Licensee; and
3.2.5    if the matter relates to [***], then the Executive Officers or their designees will submit their respective positions on such matter to be resolved by Expedited Arbitration.

3.3    Limitations on Decisions.  Notwithstanding anything herein to the contrary, without the other Party’s prior written consent, no exercise of a Party’s decision‐making authority on any matters may [***]. 

3.4    Good Faith.  In conducting themselves on the JSC, and in exercising their rights under Section 3.2, all representatives of both Parties will consider diligently, reasonably and in good faith all input received from the other Party, and will use reasonable efforts to reach unanimous agreement on all matters before them.

3.5    General JSC Authority.  The JSC has solely the powers expressly assigned to it in this Section 3.  The JSC will not have any power to amend, modify, or waive compliance with this Agreement.  It is expressly understood and agreed that the control of decision‐making authority by Licensor or Licensee, as applicable, pursuant to Section 3.2, so as to resolve a disagreement or deadlock of the JSC for any matter, will not authorize either Party to perform any function or exercise any decision‐making right not delegated to the JSC or such Party, and that neither Licensor nor Licensee has any right to unilaterally modify, amend, or waive its own compliance with the terms of this Agreement. 

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4.    DEVELOPMENT

4.1    Overview of Development, Diligence.
4.1.1    Subject to the oversight of the JSC and to Sections 4.2.3 and 4.3, Licensee shall solely control, assume all responsibility for and fund (including all Development Costs) the Development of the Products in the Field for the Territory. 
4.1.2    Licensee shall use Commercially Reasonable Efforts to Develop and obtain and maintain Regulatory Approval for a Product for Chronic Refractory Gout in [***]. The Parties acknowledge that Licensee shall not be in breach of its obligations set forth in this Section 4.1.2 or Section 4.1.3 to the extent such breach is due to Licensor and / or its Affiliates’ failure to comply with its obligations under this Agreement, including Sections 4.3, 13, 8.2, 8.3 and 8.4. 
4.1.3    Licensee (a) shall use Commercially Reasonable Efforts to conduct, or cause to be conducted, the Development of the Products under Section 4.1.2 in compliance with the Development Plan and the Development Budget, and (b) shall conduct, or cause to be conducted, the Development of the Products under Section 4.1.2 in material compliance with all applicable Law, including GCPs and GLPs, and all applicable Data Protection Laws. 
4.1.4    Each Party (but for Licensor until completion of the Licensor Development Activities) will report to the JSC in writing, on a quarterly basis, an update regarding the Development activities for the Products in the Field for the Territory conducted, and planned to be conducted during [***], by such Party, its Affiliates or, in the case of Licensee, its Sublicensees.  Each such report will contain sufficient detail to enable the other Party to assess the progress of the Development of the Products in the Field for the Territory.

4.2    Development Plan, Development Budget, Reimbursement.
4.2.1    The Parties shall agree in good faith, acting via the JSC (or its delegated subcommittee, if any), on a Development Plan and Development Budget for the Products [***] days following the Effective Date.  The Parties, acting via the JSC (or its delegated subcommittee, if any), shall review and, if deemed necessary, shall update the Development Plan and Development Budget, on an annual basis (or more frequently as required by Licensee or reasonably requested by Licensor).  Licensee shall design the Development activities set forth in the Development Plan to be in material compliance with all applicable Laws and professional and ethical standards customary in the pharmaceutical industry.
4.2.2    Licensee shall reimburse the Development Costs incurred by Licensor, in accordance with the payment schedule and budget set out in the Development Budget, upon the completion of each of the Existing Pivotal Trials and for performance of any Additional Compound Development Activities and, subject to Section 4.2.3, any Additional ImmTOR Development Activities, provided that Licensee shall have no obligation to reimburse Licensor for amounts incurred in excess of such payment schedule and budget set out in the Development Budget for any of the foregoing studies or activities which have not been approved by Licensee through the JSC.
4.2.3    Licensor shall bear the Development Costs for any portion of any Additional ImmTOR Development Activities [***].
4.2.4    Except as provided by Section ‎4.2.3, Licensee will bear all Development Costs for the Product.

4.3    Development Activities.
4.3.1    Licensor shall retain responsibility for, sponsor and conduct (or ensure the conduct by its relevant Affiliates or permitted Third Parties) the Existing Pivotal Trials (including any 

25

follow-up treatment of patients therein following the conclusion or termination of such trials), each as included in the Development Plan and in accordance with the Development Plan. In the event of either (a) on Licensee’s request upon a Change of Control of Licensor or (b) subject to Section 19.9 and a determination by the JSC, a breach by Licensor of its obligation to diligently perform the Existing Pivotal Trials  (a “Licensor Development Breach), Licensor, at Licensee’s cost, shall promptly handover responsibility for, sponsorship of and the conduct of the Existing Pivotal Trials to Licensee (or its nominated Affiliate or Third Party) in a smooth, efficient and timely manner, and as directed by the JSC.
4.3.2    Licensor shall perform such additional Development activities in relation to ImmTOR as are reasonably necessary to support Development of Products capable of attaining Regulatory Approval in the Territory and approved by the JSC (“Additional ImmTOR Development Activities”). In addition, Licensor shall perform such additional Development activities in relation to the Compound as are reasonably necessary to support Development of Products capable of attaining Regulatory Approval in the Territory or Exploitation of Products in the Territory, and approved by the JSC (“Additional Compound Development Activities”).  Licensee shall have the right to unilaterally terminate the provision of the Additional ImmTOR Development Activities and the Additional Compound Development Activities upon notice to the Licensor via the JSC. Upon receipt of such notice, Licensor, at Licensee’s cost, shall promptly handover responsibility for, sponsorship of (to the extent relevant) and the conduct of the same to Licensee (or its nominated Affiliate or Third Party) in a smooth, efficient and timely manner, and as directed by the JSC.
4.3.3    Licensor shall conduct the Licensor Development Activities promptly, using reasonable skill and care and in a professional and diligent manner, at least to the same degree of accuracy, completeness, efficiency, quality, responsiveness and timeliness as Licensor would utilize in performing similar activities for the Development of its own products that are at a similar stage of Development and have similar market potential for Licensor, in accordance with sound and ethical business and scientific practices, and in compliance with the Development Plan, the Development Budget, all applicable Law, including GCPs and GLPs, and all applicable Data Protection Laws. 
4.3.4    Licensor shall be permitted to utilize the services of its Affiliates or its material Third Party subcontractors listed on Annex E or other Third Party subcontractors to which Licensee gives its prior written approval (such approval not to be unreasonably withheld, conditioned or delayed) in the performance of the Licensor Development Activities, provided that Licensor shall remain at all times fully liable for the performance of the Licensor Development Activities in compliance with this Agreement. In all cases, the rights granted to any subcontractor shall be subject and subordinate to the applicable terms and conditions of this Agreement.  Licensor shall oversee the performance by its subcontractors of the subcontracted Licensor Development Activities in a manner that would be reasonably expected to result in their timely and successful completion of such activities, and Licensor shall remain responsible and primarily and fully liable for the performance of such activities in accordance with this Agreement.  Licensor hereby expressly waives any requirement that Licensee exhaust any right, power or remedy, or proceed against such subcontractor for any obligation or performance hereunder, prior to proceeding directly against Licensor.  Licensor shall ensure compliance with the applicable terms of this Agreement by any such subcontractor, including with respect to provisions on confidentiality and intellectual property ownership and compliance with legal requirements.  Without limiting the foregoing, to the extent that Licensor uses a subcontractor to perform Licensor Development Activities, Licensor shall ensure that such subcontractors are obligated to assign rights to any Inventions made by such subcontractors so that such rights can be conveyed in accordance with the terms and conditions of this Agreement.
4.3.5    Licensor shall not use in any capacity, in connection with its performance of the Licensor Development Activities, any Person who has been debarred pursuant to Section 306 of the FFDCA (or similar applicable Law outside of the U.S.), or who is the subject of a conviction described in such section, and shall inform Licensee in writing promptly if it or any Person who is performing 

26

services for Licensor hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA (or similar applicable Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensor’s knowledge, is threatened, relating to the debarment of Licensor or any Person used in any capacity by Licensor in connection with its performance of the Licensor Development Activities.
4.3.6    Licensor shall maintain (and cause each of its Affiliates and subcontractors to maintain) complete, current and accurate hard and electronic records of all Licensor Development Activities conducted by it and all data and other information resulting from such work (which records shall include, as applicable, books, records, reports, research notes, charts, graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof (e.g., samples of materials and other graphic or written data generated in connection with the Licensor Development Activities)).  Such records shall properly reflect all work done and results achieved in the performance of the Licensor Development Activities in sufficient detail and in good scientific manner appropriate for regulatory and patent purposes.  Licensor shall (and shall cause each of its Affiliates and subcontractors to) document all preclinical studies and clinical trials to be conducted in formal written study reports according to applicable national and international (e.g., ICH, GCP and GLP) guidelines.  Licensee shall have the right to receive and retain a copy of all such records and to review them in person upon written notice to Licensor, during regular business hours.  Licensee shall also have the right to conduct reasonable quality assurance inspections and audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Licensor, its Affiliates and subcontractors where Licensor Development Activities are conducted, as is reasonably necessary for the purposes of verifying Licensor’s compliance with this Agreement and all applicable Law, including GCPs and GLPs, and all applicable Data Protection Laws. All audits initiated by Licensee will be at Licensee’s sole expense, upon written notice to Licensor, during regular business hours.
4.3.7    [***], Licensor shall Manufacture, supply (or have Manufactured and supplied) and have delivered the Product for the purposes of conducting the Licensor Development Activities. [***]. 
4.3.8    Licensee shall not use in any capacity in connection with the Exploitation of the Products, any Person who has been debarred pursuant to Section 306 of the FFDCA (or similar applicable Law outside of the U.S.), or who is the subject of a conviction described in such section.  Licensee shall inform Licensor in writing promptly if it or any Person who is performing services for Licensee hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA (or similar applicable Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensee’s knowledge, is threatened, relating to the debarment of Licensee or any Person used in any capacity by Licensee in connection with its Exploitation of the Product.
4.3.9    Licensee shall (and shall cause each of its Affiliates and its Sublicensees engaged in the Development of the Products to) maintain current and accurate records of all Development activities conducted by it and all data and other information resulting from such work (which records shall include, as applicable, books, records, reports, research notes, charts, graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof (e.g., samples of materials and other graphic or written data generated in connection therewith)).  Such records shall properly reflect all work done and results achieved in the performance of such Development activities in sufficient detail and in good scientific manner appropriate for regulatory and patent purposes.  Licensee shall, and shall cause each of its Affiliates and its Sublicensees engaged in the Development of the Products to, document all preclinical studies and clinical trials to be conducted in formal written study reports according to applicable national and international (e.g., ICH, GCP and GLP) guidelines.

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5.    COMMERCIALIZATION

5.1    Diligence.
5.1.1    Licensee shall solely control and assume all responsibility, at its sole cost, for conducting all Commercialization activities within the Territory relating to the Products, including marketing, promotion, sales detailing and any other activities relating to the Commercialization of the Products or Sublicense of Commercialization rights to the Products.
5.1.2    Licensee shall use Commercially Reasonable Efforts to Commercialize a Product for Chronic Refractory Gout in [***].  

5.2    Trademark Use.  Licensee may, in its sole discretion, package, label, market, promote and sell the Product in the Territory under any Trademark.  The fees and expenses incurred in connection therewith will be the sole responsibility of Licensee.

5.3    Commercialization Updates.  Licensee will report to the JSC in writing, on an annual basis in the first calendar quarter of each calendar year beginning with the calendar year following the first Regulatory Approval of a Product in the Field in the Territory (for the period ending December 31 of the prior calendar year), summarizing in reasonable detail Licensee’s and, if applicable, its Affiliates’ and its Sublicensees’, Commercialization activities for the Products performed to date (or updating such report for activities performed since the last such report was given hereunder, as applicable) and those planned to be performed during the upcoming calendar year.  Each such report will contain sufficient detail to enable Licensor to assess the progress of Commercialization of the Products in the Territory. Licensee will keep the JSC reasonably informed of Licensee’s, and, if applicable, its Affiliates’ and its Sublicensees’, Commercialization activities with respect to the Product in the Territory. 

6.    PAYMENTS

6.1    Up-Front Payment.  In partial consideration of the rights granted hereunder and subject to the terms and conditions stated herein, Licensee shall pay to Licensor a non-refundable and non-creditable up-front payment of seventy-five million U.S. dollars (U.S.$75,000,000) (the “Up-Front Payment”) within forty-five (45) days of the Effective Date. 

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6.2    Development and Regulatory Milestone Payments.
6.2.1    In partial consideration of the rights granted hereunder and subject to the terms and conditions stated herein, Licensee shall make the following non-refundable and non-creditable payments (each, a “Development Milestone Payment”) to Licensor upon the first occurrence of the corresponding milestone events specified below by Licensee or any of its Affiliates or Sublicensees (each a “Development Milestone Event”): 
	
			
	 
	Development Milestone Event
	Development Milestone Payment:

	1.    
	[***]
	[***] U.S. dollars (U.S.$[***])

	2.    
	[***]
	[***] U.S. Dollars (U.S.$[***])

	3.    
	[***]
	[***] U.S. dollars (U.S.$[***])

	4.    
	[***]
	[***] U.S. Dollars (U.S.$[***)

	5.    
	[***]
	[***] U.S. Dollars (U.S.$[***])

	6.    
	[***]
	[***] U.S. Dollars (U.S.$[***])

6.2.2    Such Development Milestone Payments shall be paid only once on the first occurrence of such Development Milestone Event by Licensee or any of its Affiliates or Sublicensees, notwithstanding the potential Development of multiple Products hereunder which may involve separate clinical trials or Regulatory Approvals and regardless of how many times such Development Milestone Event is achieved and/or the number of Products that achieve such Development Milestone Event; provided, however, that if such first Product fails to achieve all Development Milestone Events, Licensee will owe Licensor the Development Milestone Payments corresponding to the achievement by the next most advanced Product of all Development Milestone Events not previously achieved by such first Product, and so forth with each next most advanced Product until all Development Milestone Payments corresponding to achieved Development Milestone Events have been paid to Licensor.
6.2.3    Licensee shall promptly, and in any event within [***] Business Days, notify Licensor following the first occurrence of a Development Milestone Event.  Following receipt of such notice, Licensor shall issue an invoice for the corresponding Development Milestone Payment which shall be paid by Licensee, or its designated Affiliate, to Licensor within [***] days after receipt of an invoice from Licensor. 

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6.3    Sales Milestone Payments.
6.3.1    In partial consideration of the rights granted hereunder and subject to the terms and conditions stated herein, Licensee shall make the following non-refundable and non-creditable payments to Licensor (each, a “Sales Milestone Payment”) when Annual Net Sales by Licensor, its Affiliates or its Sublicensees of all Products across all Indications in the Territory first reach the threshold values indicated below during the Term (each a “Sales Milestone Event”):
	
		
	Sales Milestone Event
	Milestone Payment

	Annual Net Sales of all Products in the Territory first exceeds [***] US Dollars (U.S.$[***])
	[***] US Dollars (U.S.$[***])

	Annual Net Sales of all Products in the Territory first exceeds [***] US Dollars (U.S.$[***])
	[***] US Dollars (U.S.$[***])

	Annual Net Sales of all Products in the Territory first exceeds [***] US Dollars (U.S.$[***])
	[***] US Dollars (U.S.$[***])

	Annual Net Sales of all Products in the Territory first exceeds [***] US Dollars (U.S.$[***])
	[***] US Dollars (U.S.$[***])

	Annual Net Sales of all Products in the Territory first exceeds [***] US Dollars (U.S.$[***])
	[***] US Dollars (U.S.$[***])

	Annual Net Sales of all Products in the Territory first exceeds [***] US Dollars (U.S.$[***])
	[***] US Dollars (U.S.$[***])

	Annual Net Sales of all Products in the Territory first exceeds [***] US Dollars (U.S.$[***])
	[***] US Dollars (U.S.$[***])

6.3.2    Such Sales Milestone Payments shall be paid by Licensee, or its designated Affiliate, to Licensor within [***] days after receipt of an invoice from Licensor, such invoice to be issued concurrently with the invoice issued under Section 6.6.1 for the relevant Royalty Reporting Quarter in which the first occurrence of the Sales Milestone Event set forth above takes place.  Such Sales Milestone Payments shall be paid only once, regardless of how many times such Sales Milestone Event is achieved and/or the number of Products that achieve such Sales Milestone Event; provided, however, that if multiple Sales Milestone Events are achieved in a single calendar year, all corresponding Sales Milestone Payments will be made in such calendar year (e.g., Annual Net Sales of Products of U.S.$[***] in a calendar year would result in payment of a U.S.$[***] Sales Milestone Payment (U.S.$[***] plus U.S.$[***] plus U.S.$[***])). 
6.3.3    Annual Net Sales in a given country shall not be considered for the purposes of the calculation of the Sales Milestone Events in this Section 6.3 following expiration of the Royalty Term in a such country.

6.4    Royalty.
6.4.1    In partial consideration of the rights granted hereunder and subject to the terms and conditions stated herein, during the Royalty Term, Licensee shall pay to Licensor a royalty (“Royalty”) on worldwide aggregate Annual Net Sales of Products in the Territory by Licensee, its Affiliates and its Sublicensees in a given calendar year at the royalty rate calculated in accordance with the following table, subject to reduction as set forth in Section 6.5 below: 
(a)    [***] percent ([***]%) on the first [***] U.S. dollars (U.S.$[***]) in Annual Net Sales within the Territory;

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(b)    [***] percent ([***]%) on Annual Net Sales greater than [***] U.S. dollars (U.S.$[***]) up to and including [***] U.S. dollars (U.S.$[***]) in Annual Net Sales within the Territory;
(c)    [***] percent ([***]%) on Annual Net Sales greater than [***] U.S. dollars (U.S.$[***]) up to and including [***] U.S. dollars (U.S.$[***]) within the Territory; and
(d)    [***] percent ([***]%) on Annual Net Sales in excess of [***] U.S. dollars (U.S.$[***]) within the Territory.
6.4.2    No multiple royalties will be payable under this Section 6.4 regardless of the number of Valid Claims in any Licensed Patent covering a Product.
6.4.3    Licensee’s obligation to pay royalties pursuant to this Section 6.4 for a Product in any given country shall expire on the expiration of the Royalty Term for such Product in such country.

6.5    Royalty Reductions.
6.5.1    Subject to Section 6.5.4, if during the Royalty Term, on a country-by-country and Product-by-Product basis, such Product ceases to be covered by a Valid Claim of a Licensed Patent in such country of sale, [***] then the Royalties payable under Section 6.4 shall be reduced by [***] percent ([***]%) for such Product in such country from the first calendar quarter in which this Section 6.5.1 applies through the remainder of such Royalty Term.
6.5.2    Subject to Section 6.5.4, in the event that during the Royalty Term, on a country-by-country and Product-by-Product basis:
(a)    there occurs a Loss of Market Exclusivity with respect to such Product in such country, then from the first calendar quarter this Section 6.5.2(a) applies, the Royalties payable under Section 6.4 for such Product in such country shall be reduced by [***] percent ([***]%) [***]; or
(b)    [***].
6.5.3    Subject to Section 6.5.4, if during the Royalty Term, Licensee or any of its Affiliate pays Third Party Payments with respect to a Product, Licensee may credit [***] percent ([***]%) of such Third Party Payments paid in a given calendar quarter against the Royalties otherwise due to Licensor on the Annual Net Sales of such Product in such calendar quarter under Section 6.4, provided, however that the Royalties paid to Licensor on Annual Net Sales of such Product in such calendar quarter after application of such credit shall not be less than [***] percent ([***]%) of those otherwise due under Section 6.4 without such credit.  [***].
6.5.4    In no event will the Royalties otherwise due to Licensor on the Annual Net Sales of any Product in any calendar quarter under Section 6.4 be reduced in any such calendar quarter by more than [***] percent ([***]%) of the amount that otherwise would have been due and payable to Licensor in such calendar quarter but for the reductions set forth in Sections 6.5.1, 6.5.2(a), 6.5.2(b) and 6.5.3 (the “Minimum Floor”).

6.6    Payment and Reports.
6.6.1    Within (a) [***] days after the end of each of the first three calendar quarters of each year during the Royalty Term, or (b) the later of (i) [***] days after the end of the final quarter of each calendar year during the Royalty Term and (ii) the date of [***], but, in no event for this clause (b), later than [***] days after the end of the final quarter of each calendar year during the Royalty Term (each such quarter in (a) and (b), a “Royalty Reporting Quarter”), Licensee shall provide Licensor with a written 

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report setting forth (A) the number of units of each Product sold by Licensee, its Affiliates or its Sublicensees on which Royalties are owed to Licensor, (B) the gross amount received for such sales in clause (A), (C) the Annual Net Sales during such Royalty Reporting Quarter, including any deductions taken as permitted under such definition, (D) the amount of any credits or reductions, if any, taken or made pursuant to Section 6.5, (E) the calculation of the Royalty payable to Licensor for such Annual Net Sales pursuant to Section 6.4, and (F) the computations for any applicable currency conversions pursuant to Section 6.6.3.  Upon receipt of such report, Licensor shall promptly issue an invoice for an amount equal to the total Royalty due, if any, to Licensor pursuant to this Section 6.  All payments shall be made to Licensor within [***] days of receipt of Licensor’s invoice, in United States Dollars. 
6.6.2    All payments to be made between the Parties under this Agreement will be made in United States dollars.  Each payment to be made to Licensor under this Agreement will be made by bank wire transfer in immediately available funds to such bank account as may be designated in writing by Licensor from time to time.
6.6.3    Sales made in currencies other than United States Dollars shall be converted to United States Dollars using the exchange rates published by Swedish Central Bank, on the last day of the calendar quarter in which the applicable sales were made.
6.6.4    In the event that, by reason of applicable Law in any country, it becomes impossible or illegal for Licensee to transfer, or have transferred on its behalf, payments owed Licensor hereunder, then Licensee will promptly notify Licensor of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country to the credit of Licensor in a recognized banking institution designated by Licensor or, if none is designated by Licensor within a period of [***] days, in a recognized banking institution selected by Licensee and identified in a written notice given to Licensor.
6.6.5    In addition, Licensee shall within [***] days after the end of each calendar year during the Term provide Licensor, at least annually during the Royalty Term, with reports of the Annual Net Sales by Licensee, its Affiliates and its Sublicensees during the prior calendar year.

6.7    Other Amounts Payable.  Within (a) [***] days after the end of each of the first three calendar quarters of each year during the Term, or (b) the later of (i) [***] days after the end of the final quarter of each calendar year during the Term and (ii) the date of [***], but, in no event for this clause (b), later than [***] days after the end of the final quarter of each calendar year during the Term, each Party will invoice the other Party for any amounts owed by the other Party under this Agreement that are not otherwise accounted for in this Section 6, including payments by Licensee to Licensor under the Development Plan and Development Budget in accordance with Section 4.2.2, and payments made on account of costs, expenses, damages or recoveries pursuant to Sections 9.3, 9.4, and 9.5.  The owing Party will pay any undisputed amounts within [***] days of receipt of the invoice, and any disputed amounts owed by a Party will be paid within [***] days of resolution of the dispute pursuant to Section 17.2.1.

7.    RECORD KEEPING, AUDIT RIGHTS

7.1    Record Keeping.  Each Party shall (and shall ensure that its Affiliates and its Sublicensees) keep, complete, true and accurate books of accounts of record to permit verification of payments made hereunder.  Such records shall be maintained for the period equal to the later of (i) [***] years from the date on which they were generated, or (ii) as required by applicable Law.

7.2    Audit Rights.  Each Party (the “auditing Party”) shall have the right to have an independent third party nationally-recognized accounting firm (the “Auditor”) reasonably acceptable to the other Party (the “audited Party”) access the books and records of the audited Party and its Affiliates solely to the extent necessary to verify the accuracy of the reports and payments made hereunder, provided that, where 

32

Licensor is the auditing Party, it shall have the right to require Licensee to permit Licensor’s auditor to accompany Licensee when Licensee exercises its audit rights (or, if Licensee does not intend to exercise its right to audit such Sublicensee within the relevant calendar year, to require Licensee to exercise such right) under any Sublicenses that have been granted as of the date of such audit to permit the Auditor to have access to the books and records of the corresponding Sublicensees.  Such audit shall be conducted upon at least [***] days advanced written notice to the audited Party and shall commence on a date reasonably acceptable to both Parties, not to be later than [***] calendar days after the auditing Party’s notice.  Such audit shall only be during the audited Party’s normal business hours.  [***].  The Auditor shall be required to sign a confidentiality agreement for the benefit of, and in a form reasonably acceptable to, the audited Party.  The audited Party shall be provided the opportunity to discuss any discrepancies found during such audit with the Auditor prior to such Auditor issuing its final report.  In addition, the Auditor shall redact any Confidential Information disclosed in the proposed final report reasonably identified by the audited Party as confidential and not necessary for purposes of calculating the Royalty or the milestones owed.  The final report shall be shared with both of the Parties.  If any audit discloses any underpayments by the audited Party to the auditing Party, then unless contested by the audited Party, such underpayment, shall be paid by the audited Party to the auditing Party within [***] calendar days of it being so disclosed.  If any audit discloses any overpayments by the audited Party to the auditing Party, then unless contested by the auditing Party, the audited Party shall have the right to credit the amount of the overpayment against each subsequent quarterly Royalty payment due to the auditing Party until the overpayment has been fully applied.  If the overpayment is not fully applied prior to the final quarterly payment of Royalties due hereunder, the auditing Party shall promptly refund an amount equal to any such remaining overpayment.  If the auditing Party’s audit demonstrates an underpayment of more than [***] percent ([***]%) of the total payments due to the auditing Party hereunder during the audited period, the audited Party shall be liable for the auditing Party’s reasonable out of pocket expenses, including the Auditor’s fees and expenses, in connection with the audit that discovered such underpayment.  Otherwise, the auditing Party shall solely bear the costs of such audits.  Any contested amounts shall be subject to the dispute resolution procedures set forth in Section 17.2.1. 

7.3    Taxes.
7.3.1    Where required to do so by applicable Law or order of a Governmental Authority, Licensee shall be permitted to withhold Taxes required to be paid to a taxing authority in connection with any and all payments to Licensor hereunder (“Withholding Taxes”), and, upon request of Licensor, Licensee shall furnish Licensor with satisfactory evidence of such withholding and payment.  To the extent permitted by Law, Licensor shall provide Licensee any Tax forms requested by Licensee that may be reasonably necessary in order for Licensee to not withhold Tax or to withhold Tax at a reduced rate under an applicable bilateral income tax treaty.  Licensor shall use reasonable efforts to provide any such Tax forms to Licensee in advance of the due date.  The Parties acknowledge and agree that no Withholding Taxes are expected to be deducted or withheld from payments under this Agreement.
7.3.2    Notwithstanding anything to the contrary in this Agreement, in the event a Party (i) undertakes a “redomiciliation” (as defined below), (ii) assigns, delegates or otherwise transfers this Agreement or all or any portion of its rights and obligations hereunder (including for sake of clarification the assignment or delegation of any payment obligations under this Agreement) to another Person, including pursuant to Section 19.5, other than at the request of the other Party or (iii) adopts a Tax reporting position that Swedish Withholding Taxes are applicable to payments made to Licensor under this Agreement (other than as a result of a change in Law after the date of this Agreement) (each, a “Tax Action” and such Party, the “Acting Party”), and as a result of such Tax Action the amount of Withholding Taxes required to be withheld under this Section 7.3 in respect of a payment to the other Party (the “Non-Acting Party”) is greater than the amount of such Withholding Taxes that would have been required to have been withheld absent such Tax Action, then any such amount payable to the Non-Acting Party shall be adjusted to take into account such Withholding Taxes as may be necessary so that, after making all required withholdings, the Non-Acting Party receives an amount equal to the sum it would have received 

33

had no such increased withholding been made. The obligation to adjust payments pursuant to the preceding sentence shall not apply, however, to the extent such increased Withholding Tax (a) would not have been imposed but for a Tax Action taken by the Non-Acting Party pursuant to the preceding sentence or (b) is attributable to a the failure of  the Non-Acting Party to comply with the requirements of this Section 7.3. To the extent the Non-Acting Party receives additional amounts under this Section 7.3.2 and the Non-Acting Party (or its Affiliates), taken as a whole, actually realizes an overall reduction in cash Taxes otherwise due in any taxable period ending before the termination of this Agreement (determined on a with and without basis and taking into account the overall Tax liability of the Non-Acting Party (and its Affiliates)) as a result of a foreign Tax credit or a Tax refund attributable to such Withholding Taxes in respect of which the Non-Acting Party received additional amounts pursuant to this Section 7.3.2 (such reduction, a “Tax Benefit”), the Non-Acting Party shall pay to the Acting Party an amount equal to such Tax Benefit, net of all reasonable out-of-pocket expenses incurred by the Non-Acting Party in connection with the obtaining or receipt of such Tax Benefit.  For purposes of this Section 7.3, a “redomiciliation” shall include a reincorporation or other action resulting in a change in Tax residence of the applicable Party, its assignee or any Person making a payment on behalf of such Party, or the formation of a branch of any such Party or Person in a jurisdiction other than Sweden, in the case of Licensee, or the United States, in the case of Licensor, but only to the extent that a payment under this Agreement is made by such branch.

7.4    Late Payments.  Any milestone payments or Royalties due to Licensor under this Agreement or any portion thereof which are not paid when due, shall bear interest at a per-annum rate of prime (as reported in The Wall Street Journal (U.S., Eastern Edition)) plus [***] percentage points ([***]%) or the maximum rate allowable by applicable Law, whichever is less.

8.    REGULATORY

8.1    Regulatory Matters.
8.1.1    Licensee shall solely control and assume all responsibility, [***], for submitting all Regulatory Filings for the Products in the Territory (including pricing and reimbursement approvals) and obtaining and maintaining all Regulatory Approvals and for all interactions with Regulatory Authorities for the Products in the Territory, including any and all INDs, BLAs and MAAs, provided however that Licensor shall continue to control, hold in its name and remain responsible for the IND for SEL-212 (including any updates thereto) which is required to be submitted and held by Licensor in connection with the performance of its obligations under Section 4.3.1 [***] prior to transfer of the same under Section 8.2.
8.1.2    Subject to Section 8.1.1, during the Term, all Regulatory Filings relating to the Products shall be submitted and all Regulatory Approvals shall be held solely in the name of Licensee, its Affiliates or its Sublicensees.
8.1.3    Licensor shall have [***] Business Days (or, in the event the relevant Regulatory Authority requires an urgent response, such time period as is reasonable in the circumstances) to review and comment on Regulatory Filings for the Products to the extent pertaining to ImmTOR prior to the filing thereof with a Regulatory Authority and Licensee shall reasonably consider all such comments; provided, however, that, with respect to such timely comments provided by Licensor regarding any statement Licensee proposes to make that specifically concern ImmTOR, Licensee will consider in good faith such Licensor comments, provided, that notwithstanding the foregoing, if the intended statement is consistent with a previous statement made publicly by Licensor regarding ImmTOR in its Regulatory Filings, Licensee shall be permitted to make such statement regardless of Licensor’s comments. 

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8.1.4    Licensee shall exclusively own:
(a)    subject to Section 8.1.1, all Regulatory Filings for the Products;
(b)    all information and data (including clinical and non-clinical data) generated by or on behalf of Licensee in connection with the Products, including clinical data generated in connection with the Existing Pivotal Trials;
(c)    subject to Section 8.1.1, any and all (pre-) INDs, BLAs, MAAs, and other similar Regulatory Approvals filed or awarded in any jurisdiction in the Territory related to the Products; and 
(d)    all Confidential Information of Licensee.

8.2    Regulatory Transfer.
8.2.1    [***], Licensor shall, as promptly as reasonably practicable, but in no event later than [***] days following the Effective Date, transfer to Licensee (a) all Regulatory Filings and Regulatory Approvals related to SEL-212 (other than the IND for SEL-212 which is required to be held by Licensor in connection with the performance of its obligations under Sections 4.3.1 and 4.3.2), (b) all other Regulatory Materials, including copies of all written communications with the FDA and other Regulatory Authorities in the Territory (including for clarity, all eCTD sequences and source documents referenced therein), and (c) the minutes of any meetings with the FDA and any such other Regulatory Authority, in each case of (a), (b) and (c), relating to the Compound and /or SEL-212 and including all ownership and rights thereto and including all eCTD sequences and source documents referenced therein.
8.2.2    [***], Licensor shall, as promptly as reasonably practicable after the date of completion of treatment and follow up (day [***] of the final treatment period) for the last patient enrolled in the last of the Existing Pivotal Trials (unless the Parties agree via the JSC that Licensor should continue to hold the IND in connection with any ongoing Additional Compound Development Activities or Additional ImmTOR Development Activities, in which case the Parties will agree via the JSC an appropriate transfer date), but in no event later than [***] days following such completion, transfer to Licensee the IND for SEL-212 (including all ownership and rights thereto) which was required to be held by Licensor in connection with the performance of its obligations under Sections 4.3.1 and 4.3.2, unless Licensee otherwise requests its earlier transfer, in which case, the transfer shall be made as promptly as reasonably practicable, but in no event later than [***] days following Licensee’s request therefor, and in such case Licensor’s obligations under Sections 4.3.1 and 4.3.2 to perform the Licensor Development Activities for which such IND for SEL-212 is required to be held by Licensor will terminate as of the effective date of such transfer.
8.2.3    In support of the transfers contemplated by Sections 8.2.1 and 8.2.2 and without affecting the cost allocation specified thereunder for such transfers, Licensor, [***], shall execute all additional documents and take all additional actions, including any additional filings with the relevant Regulatory Authorities, as are necessary or otherwise reasonably requested by Licensee to vest all ownership and rights to such Regulatory Filings and Regulatory Approvals with Licensee and to reflect Licensee as the holder of all such Regulatory Filings and Regulatory Approvals.

8.3    Regulatory Support.
8.3.1    Licensor shall provide all reasonable assistance and support to Licensee, on Licensee’s reasonable request, to enable Licensee, its Affiliates and/or Sublicensees to prepare and submit Regulatory Filings for the Products in the Territory, which services will be provided at the FTE Rate and subject to a mutually agreed budget.  Within [***] days of the end of every [***] month period following the Effective Date, Licensor shall issue invoices, along with supporting documentation, of all costs 

35

incurred in providing the agreed assistance and support in accordance with this Section 8.3 in such [***] month period.  Licensee shall, within [***] days of receipt of an invoice and supporting documentation from Licensor, reimburse Licensor the FTE Cost for all agreed assistance and support provided in accordance with this Section ‎8.3.

8.4    Licensee Access. Without limiting its obligations under this Agreement, as promptly as reasonably practicable, but in no event later than [***] days following the Effective Date or at Licensee’s request, Licensor shall (and shall ensure that its Affiliates and (sub)licensees):
(a)    give Licensee the right to use and reference all Development work product, Regulatory Materials, Regulatory Filings and Regulatory Approvals (including all data and information referenced therein) to the extent: (i) Controlled by Licensor or its Affiliates or its (sub)licensees during the Term; and (ii) related to the Compound; and
(b)    provide the FDA or any other Regulatory Authority in the Territory with information necessary for purposes of assisting Licensee with obtaining Regulatory Approvals for the Products in the Territory through a right to reference, all Development work product, Regulatory Materials, Regulatory Filings and Regulatory Approvals (including all data and information referenced therein) related to ImmTOR to the extent: (i) Controlled by Licensor, its Affiliates or (sub)licensees as of the Effective Date or during the Term, and (ii) related to the Product or reasonably necessary or reasonably useful to Licensee’s exercise of the License,
in each case, for use solely by and for the benefit of Licensee and its Affiliates and Sublicensees in connection with the Exploitation of the Products, at no cost to Licensee and provided that Licensor may redact any information or data not related to the Product.  Notwithstanding the foregoing, neither Licensee nor any of its Affiliates shall give access or other rights with respect to such Development work product, Regulatory Materials, Regulatory Filings and Regulatory Approvals (including all data and information referenced therein) to any of their Sublicensees, unless Licensee’s Sublicense with such Sublicensee permits Licensee the right to provide equivalent rights to Licensor to those set out in Section 8.5 in respect of such Sublicensee’s Development work product, Regulatory Materials, Regulatory Filings and Regulatory Approvals (including all data and information referenced therein).

8.5    Licensor Access. Licensee shall (and shall ensure that its Affiliates and Sublicensees), at no cost to Licensor, give Licensor the right to use and reference all Development work product, Regulatory Materials, Regulatory Filings and Regulatory Approvals (including all data and information referenced therein) to the extent:
8.5.1    Controlled by Licensee or its Affiliates or its Sublicensees during the Term; and
8.5.2    related to ImmTOR (but not the Compound and/or the Products),
in each case for use solely by and for the benefit of Licensor and its Affiliates and (sub)licensees in connection with their Exploitation of ImmTOR, whether alone or in combination (but not in combination with the Compound and/or in the form of the Products), and provided that Licensee may redact any information or data not related to ImmTOR.  Notwithstanding the foregoing, neither Licensor nor any of its Affiliates shall give access or other rights with respect to such Development work product, Regulatory Materials, Regulatory Filings and Regulatory Approvals (including all data and information referenced therein) to any of their (sub)licensees, unless Licensor’s license agreement with such (sub)licensee permits Licensor the right to provide equivalent rights to Licensee to those set out in Section 8.4 in respect of such (sub)licensee’s Development work product, Regulatory Materials, Regulatory Filings and Regulatory Approvals (including all data and information referenced therein).

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8.6    Adverse Event Reporting, Safety Agreement.  To the extent permitted by and in compliance with applicable Data Protection Laws, Licensor shall notify Licensee of all information coming into its possession concerning any Adverse Event relating to the Compound, ImmTOR or the Product, and, to the extent permitted by and in compliance with applicable Data Protection Laws, Licensee shall notify Licensor of all information coming into its possession concerning any Adverse Event related to ImmTOR or the Product (to the extent relevant to ImmTOR).  Without prejudice to the foregoing, the Parties will use good faith efforts to negotiate and enter into the Safety Agreement on or before the date that is [***] days after the Effective Date or such longer period as may be mutually agreed by the Parties.  The Parties acknowledge and agree that the Safety Agreement will govern all technical safety matters relating to the Compound, ImmTOR and/or the Products arising as a result of entry into and implementation of this Agreement as more particularly set out therein.  If there is a conflict between this Agreement and the Safety Agreement, the Safety Agreement shall govern in relation to technical safety issues only.  Each Party shall comply with its respective agreements, covenants and other obligations set forth in the Safety Agreement. 

8.7    Regulatory Action Letters.  Without limiting Section 8.4, Licensor shall promptly, but in no event later than [***] Business Days, notify Licensee in writing of the receipt of any action letters from any Regulatory Authority in connection with safety or quality issues concerning the Compound, ImmTOR and / or the Product, enclosing a copy thereof.  Without limiting Section 8.5, Licensee shall promptly, but in no event later than [***] Business Days, notify Licensor in writing of the receipt of any action letters from any Regulatory Authority in connection with safety or quality issues concerning ImmTOR and/or the Product (to the extent relevant to ImmTOR) enclosing a copy thereof.

8.8    Regulatory Meetings.  Licensor shall have the right to receive advance notice, but in no event less than [***] calendar days advance notice, of meetings and calls with Regulatory Authorities related to ImmTOR, unless such meeting or call is scheduled by the Regulatory Authority on less than [***] days’ notice, in which case Licensee shall notify Licensor as soon as reasonably practicable. Licensee shall use Commercially Reasonable Efforts to obtain the right for Licensor to participate in such meetings and calls.

8.9    Global Safety Database.  Licensee shall control, and be responsible for maintaining, the global safety database for the Product from the date that is [***] months following the date on which the IND for SEL-212 is transferred to Licensee in accordance with Section 8.2.2 and Licensor shall control and be responsible for the maintenance of the global safety database until such date.

9.    INTELLECTUAL PROPERTY RIGHTS

9.1    Inventorship.
9.1.1    Inventorship for all inventions first conceived under this Agreement shall be determined in accordance with the rules of inventorship under United States patent laws. 
9.1.2    Notwithstanding anything in this Agreement to the contrary, each Party will have the right to invoke the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. § 103(c)(2) (c)(3) (the “CREATE Act”) when exercising its rights under this Agreement, but only with the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed.  In the event that a Party intends to invoke the CREATE Act, it will notify the other Party and, if invoking the CREATE Act is agreed to by the other Party, the other Party will cooperate and coordinate its activities with such Party with respect to any filings or other activities in support thereof.  The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in the CREATE Act.

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9.2    Ownership.
9.2.1    As between the Parties, Licensee shall solely and exclusively own all right, title and interest in and to [***].  Notwithstanding the foregoing, in the event that, nonetheless, Licensor, is Affiliates or its (sub)licensees, pursuant to the exercise of its rights and performance of its obligations hereunder, holds any right, title, or interest in and to any [***], then Licensor, on behalf itself and its Affiliates and its (sub)licensees, hereby does, and agrees to, assign any and all such right, title and interest to any such [***] to Licensee together with the right to file and own applications for any Patent and any Patent issuing thereon. 
9.2.2    As between the Parties, Licensor shall solely and exclusively own all right, title and interest in and to [***].  Notwithstanding the foregoing, in the event that, nonetheless, Licensee, its Affiliates or its Sublicensees, pursuant to the exercise of its rights and performance of its obligations hereunder, holds any right, title, or interest in any [***], then Licensee, on behalf of itself and its Affiliates and its Sublicensees, hereby does, and agrees to, assign any and all such right, title and interest to any such [***] to Licensor together with the right to file and own applications for any Patent and any Patent issuing thereon.
9.2.3    [***] or (c) jointly owned by both Parties if first invented jointly by the Parties or their Affiliates jointly (the “Other Joint New IP”).  [***]. Except to the extent restricted by the licenses and other rights granted to other Party under this Agreement, each Party, as joint owners, shall be entitled to practice, license, assign, and otherwise exploit its undivided interest in the Other Joint New IP without the duty of accounting or seeking consent from the other Party, provided, however, that the foregoing shall not be construed as granting or conveying to either Party any license or other rights to the other Party’s other intellectual property rights, unless otherwise expressly set forth in this Agreement.  At the reasonable written request of a Party, the other Party will in writing grant such consents and confirm that no such accounting is required to effect the foregoing regarding Other Joint New IP.
9.2.4    Licensor will promptly disclose to Licensee all [***], but in no event later than [***] days after Licensor’s intellectual property department receives notice of such invention.  Licensee will promptly disclose to Licensor all [***], but in no event later than [***] days after Licensee’s intellectual property department receives notice of such invention.  Licensee will promptly disclose to Licensor all patent applications it proposes to make in respect of [***], but in no event later than [***] days after Licensee’s intellectual property department makes such determination.
9.2.5    Each Party shall provide the other Party ([***]) with all further reasonable cooperation to give effect to the allocation of ownership, as between the Parties, of [***] and Other Joint New IP (including with respect to rights of priority), in each case as contemplated by this Section 9.2, including executing and delivering further assignments, consents, releases and other commercially reasonable documentation, and providing good faith testimony by affidavit, declaration, deposition, in person or other proper means and otherwise assisting the other Party in support of its efforts to establish, perfect, defend, or enforce its rights in its respective intellectual property.

9.3    Patent Prosecution and Maintenance.
9.3.1    Licensee.
(a)    As between the Parties, Licensee shall have the primary right and obligation, [***], using patent counsel of Licensee’s choice reasonably acceptable to Licensor (unless the Parties mutually agree to continue using Licensor’s existing patent prosecution counsel as of the Effective Date [***]), to conduct and control prosecution, maintenance, extension, applications for supplementary protection certificates related thereto, including any related interference, re-issuance, re-examination and opposition proceedings with respect thereto (collectively, “Prosecution” or “Prosecute”) with respect to [***].

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(b)    As between the Parties, Licensee shall have the sole right, at [***], to conduct and control Prosecution of [***].
(c)    Promptly after the Effective Date, and unless the Parties mutually agree to continue using Licensor’s existing patent prosecution counsel as of the Effective Date, [***].
(d)    Licensee shall keep Licensor reasonably informed of Licensee’s intellectual property and Prosecution strategy with respect to [***], including furnishing to Licensor, via electronic mail or such other method as mutually agreed by the Parties, copies of proposed filings and documents received from patent counsel in the course of Prosecuting [***], and copies of documents filed with or received from the relevant national patent offices or other Governmental Authorities with respect to such [***], and such other material documents related to the Prosecution of such [***] in sufficient time prior to filing such document or making any payment due thereunder to allow for review and comment by Licensor.  Licensee shall consider in good faith the reasonable requests and suggestions of Licensor with respect to the Prosecution of, and Licensee’s intellectual property strategy for, [***] received no later than [***] Business Days prior to any filing deadline; provided, however, that, with respect to such timely comments provided by Licensor regarding any statement Licensee proposes to make in connection with the Prosecution of [***], Licensor will have final say and Licensee will implement such Licensor comments, provided, that notwithstanding the foregoing, if the intended statement is consistent with a previous statement made publicly in Prosecution by Licensor regarding ImmTOR, Licensee shall be permitted to make such statement regardless of Licensor’s comments.
(e)    Licensee shall notify Licensor of any decision to cease Prosecution of [***] in any country in the Territory.  Licensee shall provide such notice in writing at least [***] days prior to any filing or payment due date, or any other due date that requires action, in connection with such [***].  In such event, upon Licensor’s request, Licensee shall transfer the Prosecution of such [***] in such country to Licensor (or Licensor’s licensor, as applicable), and thereafter Licensor (or Licensor’s licensor, as applicable) shall have the right to continue Prosecution of such [***], as applicable, in such country [***].
(f)    Licensor shall promptly (and in any event within [***] Business Days) provide Licensee with copies of correspondence or materials received from any Governmental Authority in the Territory to the extent they relate to [***].
(g)    Licensee shall have lead responsibility regarding strategy for making all filings with Regulatory Authorities in the Territory with respect to [***], including as required or allowed (i) in the United States, in the FDA’s Orange Book or Purple Book, and (ii) in the European Union, under the national implementations of Section 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents, provided Licensee shall consult with Licensor regarding [***].
9.3.2    Licensor.
(a)    As between the Parties, Licensor shall have the primary right and obligation, [***], to conduct and control Prosecution of the Selecta-Controlled Patents, [***].
(b)    Licensor shall keep Licensee reasonably informed of Licensor’s intellectual property and prosecution strategy with respect to the Selecta-Controlled Patents, [***], including furnishing to Licensee, via electronic mail or such other method as mutually agreed by the Parties, copies of proposed filings and documents received from patent counsel in the course of Prosecuting the Selecta-Controlled Patents, [***], and copies of documents filed with or received from the relevant national patent offices or other Governmental Authorities with respect to such Selecta-Controlled Patents, [***], and such other material documents related to the Prosecution of such Selecta-Controlled Patents, [***], in sufficient time prior to filing such document or making any payment due thereunder to allow 

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for review and comment by Licensee.  Licensor shall consider in good faith the reasonable requests and suggestions of Licensee with respect to the Prosecution of, and Licensee’s intellectual property strategy for, the Selecta-Controlled Patents, [***].
(c)    Licensor shall notify Licensee of any decision to cease Prosecution of the Selecta-Controlled Patents, [***] in any country in the Territory.  Licensor shall provide such notice in writing at least [***] days prior to any filing or payment due date, or any other due date that requires action, in connection with such Selecta-Controlled Patents, [***].  In such event, upon Licensee’s request, Licensor shall transfer the Prosecution of such Selecta-Controlled Patents, [***] in such country to Licensee, and thereafter Licensee shall have the right to continue Prosecution of such Selecta-Controlled Patents, [***] in such country [***].
(d)    Licensee shall promptly (and in any event within [***] Business Days) provide Licensor with copies of correspondence or materials received from any Governmental Authority in the Territory to the extent they relate to the Selecta-Controlled Patents [***].
(e)    As between the Parties, Licensor shall have the right in its good faith determination to make all filings with Regulatory Authorities in the Territory with respect to the Selecta-Controlled Patents, [***] pertaining to any pharmaceutical products, including as required or allowed (i) in the United States, in the FDA’s Orange Book or Purple Book and (ii) in the European Union, under the national implementations of Section 10.1.2(a)(iii) of Directive 2001/EC/83 or other international equivalents, provided Licensor shall consult with Licensee regarding such Selecta-Controlled Patents, [***].
9.3.3    Parties Jointly.
(a)    Licensee and Licensor shall jointly decide the intellectual property and prosecution strategy for the Other Joint New IP Patents, and Licensee shall be responsible for the implementation of such strategy for the Prosecution of such Other Joint New IP Patents, using patent counsel of Licensee’s choice reasonably acceptable to Licensor. [***].
(b)    Licensee shall furnish to Licensor, via electronic mail or such other method as mutually agreed by the Parties, copies of proposed filings and documents received from patent counsel in the course of Prosecuting the Other Joint New IP Patents, and copies of documents filed with or received from the relevant national patent offices or other Governmental Authorities with respect to such Other Joint New IP Patents, and such other material documents related to the Prosecution of such Other Joint New IP Patents, in sufficient time prior to filing such document or making any payment due thereunder to allow for review and comment by Licensor.  Licensee shall implement Licensor’s reasonable requests and suggestions with respect to the Prosecution of the Other Joint New IP Patents.
(c)    In the event [***] with the Prosecution of any of the Other Joint New IP Patents in any country in the Territory (the “Relinquishing Party”), the Relinquishing Part shall provide such notice in writing to the other Party (i) at least [***] days prior to any filing or payment due date, or any other due date that requires action, in connection with such Other Joint New IP Patent, where Licensee is the Relinquishing Party, or (ii) promptly, where Licensor is the Relinquishing Party.  In such event, (A) where Licensee is the Relinquishing Party, Licensee shall transfer the Prosecution of such Other Joint New IP Patent, and thereafter Licensor shall have the right to continue the Prosecution of such Other Joint New IP Patent in such country [***], and (B) where Licensor is the Relinquishing Party, Licensee shall assume sole control of the Prosecution of such Other Joint New IP Patent in such country [***], and Licensor shall no longer have review and comment rights as to the Prosecution of such Other Joint New IP Patent pursuant to Section 9.3.3(b).

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(d)    Each Party shall promptly (and in any event within [***] Business Days) provide to the other copies of correspondence or materials received from any Governmental Authority in the Territory to the extent they relate to the Other Joint New IP Patents.
9.3.4    Support, Reimbursement.
(a)    The non-prosecuting Party shall, and shall cause its Affiliates or, in the case of Licensee, its Sublicensees, including its, its Affiliate’s and its Sublicensees’ employees, contractors, and/or agents, to, assist and cooperate with the prosecuting Party, as the prosecuting Party may reasonably request from time to time, in the preparation, filing and Prosecution of Patents as permitted under this Section 9.3, including that the non-Prosecuting Party shall, and shall ensure that its Affiliates, (a) offer its comments, if any, promptly and in any event no less than [***] Business Days before any applicable due date that requires action, and (b) provide access to relevant documents and other evidence and make its employees available at reasonable business hours; provided, however, that neither Party shall be required to provide legally privileged information with respect to such intellectual property unless and until procedures reasonably acceptable to such Party are in place to protect such privilege; and provided, further, that the Prosecuting Party shall reimburse the non-Prosecuting Party for its reasonable and verifiable out-of-pocket costs and expenses incurred in connection with the non-Prosecuting Party’s obligations under this Section 9.3.4(a).
(b)    Any costs and expenses under this Section 9.3 to be reimbursed by one Party to the other shall be paid by the owing Party within [***] days of receipt of evidence that such costs and expenses have been incurred.
9.3.5    Patent Term Extension.  As between the Parties and with respect to the Products, Licensee will have lead responsibility and final decision making authority, in consultation with Licensor for [***] to apply for and obtain any patent term extension or related extension of rights, including supplementary protection certificates and similar rights, for [***] anywhere in the Territory.  Licensor shall provide reasonable assistance to Licensee in connection with obtaining any such extensions for [***] consistent with such strategy.  To the extent reasonably and legally required in order to obtain any such extension in a particular country, Licensor will make available to Licensee a copy of the necessary documentation to enable Licensee to use the same for the purpose of obtaining the extension in such country.  With respect to products other than the Products, Licensor will have the sole right to apply for and obtain any patent term extension or related extension of rights, including supplementary protection certificates and similar rights, for [***].

9.4    Infringement or misappropriation of Licensed Technology [***].
9.4.1    Notification.  If either Party should become aware of: on a Product-by-Product and country-by-country basis (a) the making, use, offer for sale, sale or import by any Third Party (other than any Sublicensee or authorized purchaser or transferee of such Product) of any pharmaceutical or biologic product in such country constituting infringement or misappropriation or alleged or threatened infringement or misappropriation of the Licensed Technology [***] in such country or (b) any certification filed under the Hatch-Waxman Act claiming that any of the Licensed Patents are invalid or unenforceable, or claiming that any of the Licensed Patents would not be infringed by the making, use, offer for sale, sale or import of any pharmaceutical or biologic product for which an application under the Hatch-Waxman Act is filed or any notice under the Biologics Price Competition and Innovation Act, or any equivalent or similar certification or notice in any other jurisdiction, that references data for a Product that was submitted to a Regulatory Authority to obtain approval to market such Product, (each of (a) and (b) a “Competitive Infringement”), it shall promptly notify the other Party in writing and provide any information available to that Party relating to such alleged Competitive Infringement.

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9.4.2    Licensee.
(a)    As between the Parties, Licensee shall have the sole right to bring or control, at its own expense, any enforcement action to abate any actual or alleged Competitive Infringement of [***], including as a defense or counterclaim in connection with any Third Party Infringement Claim.
(b)    As between the Parties, Licensee shall have the initial right (but not the obligation) to bring or control, at its own expense, any enforcement action to abate any actual or alleged Competitive Infringement of [***], including as a defense or counterclaim in connection with any Third Party Infringement Claim.  Licensee shall keep Licensor reasonably informed of Licensee’s strategy for such enforcement action, including furnishing to Licensor, via electronic mail or such other method as mutually agreed by the Parties, copies of proposed filings and material documents received from counsel in the course of such enforcement action, and copies of material documents filed with or received from the relevant court or material communications with other party to such enforcement action, and such other material documents related to such enforcement actions in sufficient time prior to filing such document or sending such document to the other party to allow for review and comment by Licensor.  Licensee shall consider in good faith the reasonable comments of Licensor with respect to such enforcement action received no later than [***] Business Days prior to any filing deadline; provided, however, that, with respect to such timely comments provided by Licensor regarding any statement Licensee proposes to make in connection with the enforcement of [***], Licensor will have final say and Licensee will implement such Licensor comments, provided, that notwithstanding the foregoing, if the intended statement is consistent with a previous statement made publicly in Prosecution or any enforcement action by Licensor regarding ImmTOR, Licensee shall be permitted to make such statement regardless of Licensor’s comments.  Licensor shall (and shall ensure that its Affiliates) reasonably cooperate, and Licensor shall use Commercially Reasonable Efforts to ensure that its licensors cooperate, in any such enforcement action, including being joined as a party to such enforcement action if reasonably necessary to establish or maintain standing and making its employees reasonably available, [***].  If Licensor is so joined, then, in the absence of any conflict of interest, the Parties shall use Commercially Reasonable Efforts to utilize the same legal counsel.
(c)    In the event that Licensee does not file an enforcement action against or commence and conclude settlement negotiations with the Third Party responsible for a Competitive Infringement of [***] within [***] days of receipt of a written demand from Licensor that Licensee bring such an enforcement action, or within [***] days of either Party’s receipt of a notice that an applicant is seeking licensure pursuant to the Hatch Waxman Act, then Licensor shall have the right to submit the matter to the JSC for the JSC to determine whether a reasonably prudent licensee would bring an action to enforce [***], as applicable in question, in light of [***].
(d)    Any costs, expenses or damages under this Section 9.4.2 to be reimbursed by one Party to the other shall be paid by the owing Party within [***] days of receipt of evidence that such costs, expenses or damages have been incurred.
9.4.3    [***].  As between the Parties, [***] shall have the sole and exclusive right (but not the obligation) to bring or control[***], any enforcement action to abate any actual or alleged Competitive Infringement of a Selecta-Controlled Patent, [***], including as a defense or counterclaim in connection with any Third Party Infringement Claim.
9.4.4    Parties Jointly.  Licensee and Licensor shall jointly decide the enforcement strategy for the Other Joint New IP Patents, and shall bring as joint party-plaintiffs any enforcement action to abate any actual or alleged Competitive Infringement of an Other Joint New IP Patent, including as a defense or counterclaim in connection with any Third Party Infringement Claim.  [***] the costs and expenses of any such action [***] all amounts received for damages upon the final judgment or settlement 

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of any such action.  In the absence of any conflict of interest, the Parties shall use Commercially Reasonable Efforts to utilize the same legal counsel.
9.4.5    Settlement.  With respect to any infringement or defensive action identified in Section 9.4.2 or Section 9.5, the Party controlling such action shall have the right to settle or otherwise dispose of such action on such terms as such Party shall determine in its sole discretion, including, in the case of Licensee, by granting a license or sublicense to a Third Party under the rights granted to Licensee under the License in accordance with the sublicensing terms of Section 2.3, as applicable. Notwithstanding the foregoing, no such settlement or other disposition will (a) impose any monetary restriction or obligation on or admit fault of the other Party or (b) adversely affect the other Party’s rights under this Agreement to any Patent then being enforced or defended, in each case ((a) and (b)), without the prior written consent of the other Party, not to be unreasonably withheld, conditioned, or delayed.
9.4.6    Recoveries.  Unless otherwise agreed by the Parties, any monetary damages recovered upon the final judgment or settlement of any action described in Section 9.4.2 shall be used first to reimburse the Party that brought the enforcement action (the “Controlling Party”) for its costs and expenses (including reasonable attorneys’ fees) incurred from the action, and any remaining amount will be distributed as follows [***].

9.5    Third Party Infringement Claims.
9.5.1    If the Exploitation of a Product results in a claim, suit or proceeding alleging patent infringement against either Party (or its Affiliates, licensees or Sublicensees) (a “Third Party Infringement Claim”), including any defense or counterclaim in connection with a Competitive Infringement initiated in connection with Section 9.4.2, such Party shall promptly notify the other Party hereto in writing.
9.5.2    [***].
9.5.3    Licensor shall, and shall cause its Affiliates to, use Commercially Reasonable Efforts to ensure that its licensors assist and cooperate with Licensee, as Licensee may reasonably request from time to time, in connection with its activities set forth in this Section 9.5, including where necessary, being joined as a party plaintiff if reasonably necessary to establish standing for such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that [***] shall reimburse [***] and its Affiliates and its licensors for their reasonable and verifiable out-of-pocket costs, damages and expenses, including reasonable attorneys’ fees (further provided the Parties shall have used Commercially Reasonable Efforts to utilize the same legal counsel) that such entity may incur in connection with such assistance or joinder, including any award of costs against it.
9.5.4    Licensee shall keep Licensor reasonably informed of all material developments in connection with any such Third Party Infringement Claim; provided, however, that, with respect to such comments provided by Licensor and received no later than [***] Business Days prior to any filing deadline regarding any statement Licensee proposes to make in connection with the enforcement of the [***], Licensee will implement such Licensor comments, provided further, that notwithstanding the foregoing, if the intended statement is consistent with a previous statement made publicly in Prosecution or any enforcement action by Licensor regarding ImmTOR, Licensee shall be permitted to make such statement regardless of Licensor’s comments.
9.5.5    Any damages or awards, including royalties, awarded to the party alleging patent infringement under any Third Party Infringement Claim defended under this Section 9.5 shall be borne by [***].  For clarity, if [***] is required to make any payment to a Third Party (including any Third 

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Party which becomes an Acquisition Entity of Licensor) to settle such Third Party Infringement Claim, such Third Party Payment shall be a Third Party Payment for the purposes of Section 6.5.3.

9.6    Defense.  To the extent either Party receives notice by counterclaim, or otherwise, alleging the invalidity or unenforceability of any Licensed Patent, it will bring such fact to the attention of the other Party, including all relevant information related to such claim.  Where such allegation is made in an opposition, reexamination, interference, post-grant proceeding or other patent office proceeding, the provisions of Section 9.3 will apply.  Where such allegation is made in a declaratory judgment action, a counterclaim to a suit or other action brought under Section 9.4, the provisions of Section 9.4 will apply.

9.7    Common Interest.  All information exchanged between the Parties regarding the Prosecution, and enforcement and defense, of Patents under this Section 9 will be deemed Confidential Information of the disclosing Party.  In addition, the Parties acknowledge and agree that, with regard to such Prosecution, and enforcement and defense of Patents under this Section 9, the interests of the Parties as collaborators and licensor and licensee are to obtain the strongest patent protection possible, and as such, are aligned and are legal in nature.  The Parties agree and acknowledge that they have not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning Patents under this Section 9, including privilege under the common interest doctrine and similar or related doctrines.  Notwithstanding anything to the contrary contained herein, to the extent a Party has a good faith belief that any information required to be disclosed by such Party to the other Party under this Section 9 is protected by attorney‐client privilege or any other applicable legal privilege or immunity, such Party will not be required to disclose such information and the Parties will in good faith cooperate to agree upon a procedure (including entering into a specific common interest agreement, disclosing such information on a “for counsel eyes only” basis or similar procedure) under which such information may be disclosed without waiving or breaching such privilege or immunity.

9.8    Third Party Patent Rights.  If, at any time during the Term, in the reasonable opinion of Licensee, it is reasonably necessary to obtain rights to a Patent of a Third Party (including any Third Party which becomes an Acquisition Entity of Licensor) for Licensee or its Affiliates or its or their Sublicensees to Exploit the Products in the Field in any country in the Territory (such right, a “Third Party Patent Right”), then, as between the Parties, [***], Licensee shall have the right, but not the obligation, to negotiate and obtain a license from such Third Party (including any Third Party which becomes an any Acquisition Entity of Licensor) to such Third Party Patent Right as necessary for Licensee or its Affiliates or its or their Sublicensees to Exploit the Products in the Field in such country; provided that subject to Section 6.5.3, as between the Parties, Licensee shall bear all expenses incurred in connection therewith, including any royalties, milestones or other payments including In-Licensor Payments, incurred under any such license.

9.9    Personnel Obligations.  Prior to beginning work under this Agreement relating to any Development or Commercialization of a Product, each employee, agent or independent contractor of Licensee or Licensor or of either Party’s Affiliates, Sublicensees or (sub)licensees will be bound by non-disclosure and invention assignment obligations which are consistent with the obligations of Licensee or Licensor, as appropriate, in this Section 9, to the extent permitted by applicable Law, including: (a) promptly reporting any invention, discovery, process or other intellectual property right; (b) assigning to Licensee or Licensor, as appropriate, all of his or her right, title and interest in and to any invention, discovery, process or other intellectual property right; (c) in the case of employees, agents, or independent contractors working in the United States, taking actions reasonably necessary to secure patent protection; (d) performing all acts and signing, executing, acknowledging and delivering any and all documents required for effecting the obligations and purposes of this Agreement; and (e) abiding by the obligations of confidentiality and non-use set forth in Section 10.  It is understood and agreed that such non-disclosure and invention assignment agreement need not reference or be specific to this Agreement.

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9.10    Rights in Bankruptcy.
9.10.1    Licenses in Bankruptcy.  All licenses granted by Licensor to Licensee under this Agreement are and shall otherwise be deemed to be, for purposes of Title 11, United States Code or foreign equivalent laws (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined in Section 101 of the Bankruptcy Code.  Licensee shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code with respect to this Agreement and any agreement supplementary hereto in accordance with Section 365(n) of the Bankruptcy Code, including the obligations of the Parties under Sections 365(n)(2), (n)(3), and (n)(4) of the Bankruptcy Code.  Licensor agrees that such intellectual property is subject to Section 365(n) of the Bankruptcy Code notwithstanding the jurisdiction of such intellectual property.  Upon the bankruptcy of Licensor, Licensee shall further be entitled to a complete duplicate of, or complete access to, any such intellectual property, and such shall be promptly delivered or made available to Licensee, unless an order approving assumption of this Agreement and any agreement supplementary hereto that is reasonably acceptable to Licensee is entered and takes effect within [***] days of the bankruptcy commencement by or against Licensor.  Upon rejection of this Agreement in an Insolvency Proceeding of Licensor, Licensor or any bankruptcy trustee shall comply with the provisions of Section 16.8 and not interfere with the rights of Licensor provided in this Agreement or any other agreement supplementary hereto to licensed or transferred pursuant to Section 16.8.
9.10.2    No termination or Rejection.  Licensor will not move for, or consent to, the termination of or rejection of this Agreement in any Insolvency Proceeding involving Licensor, notwithstanding any right Licensor may have at law to do so.  In the event that this covenant is breached and the License is terminated in whole or in part, the Parties acknowledge and agree that Licensee will suffer irreparable harm.  
9.10.3    Negative Covenant. Licensor covenants that it will not, during the Royalty Term, create, or permit to subsist, any Encumbrance (except for Permitted Encumbrances) on any of the Licensed Technology.

10.    CONFIDENTIAL INFORMATION

10.1    Confidentiality.
10.1.1    Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that, during the Term of this Agreement and for [***] years thereafter (or, with respect to Confidential Information that is a trade secret of the disclosing Party, until such trade secret no longer qualifies as a trade secret under applicable Law) (the “Confidentiality Period”), it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information of the other Party. Each Party shall promptly notify the other upon becoming aware of the occurrence of any unauthorized use or disclosure of the other Party’s Confidential Information.
10.1.2    The foregoing obligation of Section 10.1.1 shall not apply to Confidential Information which:
(a)    (other than the Licensed Know-How in the case of Licensor as disclosing Party) prior to receipt thereof from one Party was in the possession of the recipient Party without restriction, as can be demonstrated by the recipient Party through written evidence;
(b)    is subsequently disclosed to the recipient Party without obligations of confidence to the disclosing Party by a third party who has not derived it directly or indirectly from the disclosing Party;
(c)    is or becomes generally available to the public through no act or default of the recipient Party or its Affiliates, employees, contractors, agents, or Sublicensees;

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(d)    (other than the Licensed Know-How in the case of Licensor as disclosing Party) is independently Developed by the receiving Party independently and without the benefit of any disclosure hereunder, as demonstrated by documented evidence prepared contemporaneously with such independent Development.
10.1.3    During the Confidentiality Period:
(a)    all Confidential Information obtained by the receiving Party from the disclosing Party shall be used or disclosed by the receiving Party solely as required to (i) perform its obligations or exercise or enforce its rights and remedies under this Agreement, (ii) in the case of Licensee, for the Exploitation of the Product in the Field in the Territory, or (iii) in the case of Licensor, the Licensor Permitted Activities; and
(b)    Licensor and its Affiliates shall continue to protect the Licensed Know-How using the same degree of care and in accordance with the same internal processes and safeguards that it applied to the Licensed Know-How immediately prior to the Execution Date, but in any event using no less than reasonable care.
10.1.4    Notwithstanding Sections 10.1.1 or 10.1.3, Each Party may disclose Confidential Information to the extent that such disclosure is:
(a)    made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial or local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by applicable Law, including by reason of filing with securities regulators or rules of an applicable securities exchange; provided, however, that the receiving Party shall first where practicable have given notice to the disclosing Party and given the disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that such disclosing Party’s Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided, further, that the Confidential Information disclosed in response to such court or governmental order or made in such filing shall be limited to that information which is legally required to be disclosed in response to such court or governmental order or made in such filing;
(b)    made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval as permitted under this Agreement; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with applicable Law, and, further provided that,  the Parties acknowledge that any submissions of Regulatory Filings for the Products in the Field in the Territory shall be made by Licensee, its Affiliates or Sublicensees and not by Licensor;
(c)    made by or on behalf of the receiving Party to any patent office or similar authority as may be reasonably necessary or desirable for purposes of filing, prosecuting, obtaining, maintaining or enforcing its Patents as permitted under this Agreement; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent practicable and consistent with applicable Law;
(d)    made by or on behalf of the receiving Party in connection with prosecuting or defending litigation under this Agreement;
(e)    made by or on behalf of the receiving Party or its Affiliate to Affiliates, employees, directors, agents, consultants, advisors, collaborators, actual or potential Sublicensees, (sub)licensees, subcontractors, manufacturers, who, in each case, have a need to know such information 

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in order to perform Exploitation activities under this Agreement or otherwise perform such Party’s obligations or exercise such Party’s rights under this Agreement;
(f)    made or on behalf of a Party or its Affiliate to the counterparty to an Upstream Agreement, solely to the extent necessary to enable Licensor to comply with its obligations thereunder, provided, however, that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 10 and provided, further, that the Confidential Information so disclosed shall be limited to that information which is strictly required to be disclosed to enable compliance with such Upstream Agreement; or
(g)    made by or on behalf of the receiving Party to bona fide potential or actual sources of financing, investors, strategic partners, acquirers and other financial and commercial partners, and their respective attorneys, accountants, banks, investors and advisors as may be necessary in connection with their evaluation of such potential or actual investment, debt transaction, partnership, collaboration, or acquisition; provided, however, that in each case of clauses (e) and (g), such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 10.
10.1.5    Each Party shall procure that all its employees, directors, agents, consultants, advisors, collaborators, contractors, Affiliates, Sublicensees and licensees, who have access to any information of the other Party to which the obligations of this Section 10.1 apply, shall be made aware of, subject to, and comply with the above obligations.
10.1.6    The Mutual Confidential Disclosure Agreement by and between Licensor and Licensee dated January 24, 2020 (as amended, the “Confidentiality Agreement”) is hereby superseded and replaced by this Agreement, and information disclosed pursuant to such Confidentiality Agreement prior to the Effective Date will be protected as Confidential Information under this Section 10.1 of this Agreement.
10.1.7    Notwithstanding the provisions of this Section 10.1, each Party shall comply with the obligations of Licensor pursuant to Section 10.1 of the 3SBio License Agreement.

10.2    Publicity.  The Parties have agreed on the language of their respective press releases announcing this Agreement, which are attached hereto as Annex D, to be issued by the Parties promptly after the Effective Date.  Subject to the foregoing, the Parties have agreed that neither Party shall issue any public announcement, press release or other public disclosure regarding this Agreement or its subject matter without the other Party’s prior written consent, except for any such disclosure as is, in the opinion of the disclosing Party’s counsel, required by applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted). In the event a Party is, in the opinion of its counsel, required by applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable so as to provide a reasonable opportunity to comment thereon. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement or any amendment hereto that has already been publicly disclosed by such Party or by the other Party, in accordance with this Section 10.2; provided that such information remains true and accurate as of such time.

10.3    Equitable Relief.  Each Party acknowledges that a breach of this Section 10 may not reasonably or adequately be compensated in damages in an action at law and that such a breach may cause the other Party irreparable injury and damage.  Therefore, each Party agrees that the other Party 

47

shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any breach of the obligations relating to Confidential Information set forth in this Agreement. 

11.    TRANSPARENCY, DATA PROTECTION.

11.1    Transparency. Each Party acknowledges that the other Party is subject to applicable Laws related to:  (i) the collection and reporting of any payments or transfers of value to certain HCPs and teaching hospitals (collectively, “Financial Transparency Laws”), which include, without limitation, relevant provisions of the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and its implementing regulations along with similar laws and regulations in other countries; and (ii) the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs, as well as any registration, notification and reporting requirements under any state drug pricing transparency laws, and its implementing regulations, respectively, along with similar laws and regulations in other countries (collectively, “Drug Pricing Transparency Laws”, and together, with the Financial Transparency Laws, the “Transparency Laws”).  Each Party shall reasonably cooperate with the other Party in its compliance in all material respects with Transparency Laws and promptly provide any information requested by such other Party in connection with this Agreement in a mutually agreed upon format that is necessary or reasonably useful for such other Party to comply with its obligations under the Transparency Laws.  With respect to the Financial Transparency Laws, each Party shall have the right to allocate payments or other transfers of value in connection with this Agreement in any required reporting under such laws in accordance with its normal business practices.

11.2    Data Protection.  Each Party shall fully comply with its obligations under applicable Data Protection Laws in the performance of its obligations hereunder. Without limiting the foregoing:
11.2.1    to the extent a Party is the sponsor of each clinical trial, each Party shall ensure that all patient authorizations and consents required under applicable Data Protection Laws are obtained and permit the sharing of data and information by the Parties under this Agreement.  Where safety information is received outside the conduct of a clinical trial by a Party and that Party subsequently shares such safety information with the other Party under this Agreement, the disclosing Party shall ensure that all patient authorizations and consents required under applicable Data Protection Laws permit such sharing of safety information by the Parties;
11.2.2    Each Party shall, at the other Party’s expense, provide the other with such assistance as may be reasonably requested to ensure that each Party complies with their obligations under applicable Data Protection Laws.  For clarity, such assistance may include, but is not limited to cooperating in response to requests from data subjects and notifying the other Party of the receipt of such requests.
11.2.3    Each Party acknowledges that each Party is under an obligation to ensure that the Personal Data they Process in connection with this Agreement and which the disclosing Party discloses in connection with this Agreement is limited to only that which is necessary for the purposes of the Processing, therefore the disclosing Party shall, notwithstanding any other provision of this Agreement, use Commercially Reasonable Efforts to transfer only that Transferred Data which is required to facilitate the performance of this Agreement.  If the receiving Party reasonably believes that additional Personal Data is required to be disclosed to enable the performance of this Agreement, the receiving Party shall notify the disclosing Party and the Parties shall discuss in good faith whether such additional Personal Data will be disclosed by the disclosing Party, taking into account each Party’s obligations under applicable 

48

Data Protection Laws, the potential for the provision of anonymized data in place of the requested Personal Data, and any actions which are required to be taken by either Party in connection with such requested disclosure.
11.2.4    each Party (on behalf of itself, its Affiliates and its Sub-Licensees and contractors) agrees and acknowledges that (wherever possible whilst meeting the objectives of this Agreement) it:
(a)    shall ensure that the Confidential Information transferred under this Agreement cannot be used by the receiver to identify a Data Subject and does not constitute Personal Data in respect of which EU Data Protection Law applies;
(b)    shall ensure that the Confidential Information transferred under this Agreement does not constitute personally identifiable information or equivalent information under any applicable Data Protection Laws; and
(c)    shall not provide the receiver with any additional information (if any), including any key codes or any other mechanism or data, that may enable the receiving Party to attribute the Information to any identified or identifiable natural person,
and, notwithstanding the foregoing, if either Party (i) transfers Personal Data in connection with this Agreement in respect of which EU Data Protection Law applies, each Party will comply with its respective obligations as set out in Annex C, and (ii) with respect to any other Personal Data or personally identifiable information transferred or received under this Agreement, each Party shall comply with any applicable obligations under applicable Data Protection Laws, including, but not limited, to imposing the same confidentiality and security requirements as outlined in this Agreement; and
11.2.5    The Parties agree to negotiate and agree in good faith modifications to this Agreement (including Annex C) to the extent required for the Parties to transfer or Process any Personal Data or other personally identifiable information (if any) transferred or received under this Agreement in compliance with applicable Data Protection Laws or to address the legal interpretation of Data Protection Laws. Without limiting the foregoing, to the extent Licensor will Process Personal Data on behalf of Licensee, the Parties shall enter into a separate data processing agreement covering, at a minimum, the requirements of Article 28 GDPR.
11.2.6    Personal Data Breach.  In the event of a Personal Data Breach, to the extent required by applicable Data Protection Laws, the affected Party shall notify the other Party without delay upon, but no later than 48 hours after the affected Party, or any Affiliate, sublicensee or data processor, becomes aware of a Personal Data Breach and each Party shall comply with its obligations under applicable Data Protection Laws and shall provide reasonable assistance to the other Party to enable the other Party to comply with its obligations under applicable Data Protection Laws, which may include providing such reasonable information, on the other Party’s reasonable request, as is required to enable such other Party to meet any obligations (including timelines) to report or inform Data Subjects of the Personal Data Breach under the applicable Data Protection Laws.  Additionally, each Party shall use Commercially Reasonable Efforts to promptly and thoroughly investigate all incidents of unauthorized access to, use, or disclosure of Personal Data.

12.    REPRESENTATIONS, WARRANTIES AND COVENANTS

12.1    Mutual Representations and Warranties.  As of the Execution Date, each Party hereto represents and warrants to the other Party that:

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12.1.1    it is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement;
12.1.2    the execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate: (i) such Party’s charter documents, bylaws or other organizational documents; (ii) in any material respect, any agreement, instrument or contractual obligation to which such Party is bound; (iii) any requirement of any applicable Law; or (iv) any Order presently in effect applicable to such Party;
12.1.3    this Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity);
12.1.4    it is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would materially impede the fulfilment of its obligations hereunder; and
12.1.5    neither it nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates has used or will use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA (or similar applicable Law outside of the U.S.) or who is the subject of a conviction described in such section; and it will inform the other Party in writing promptly if it or any such Person who is performing services hereunder is debarred or is the subject of a conviction described in such Section 306 of the FFDCA (or similar applicable Law outside of the U.S.) or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its or its Affiliates’ knowledge, is threatened, relating to the debarment or conviction of it or any such Person performing services hereunder; and
12.1.6    it is entitled to claim the benefits of the income tax treaty between the United States and Sweden both generally as a “resident” of such jurisdiction (within the meaning of Article 4 thereof) and under the Limitation on Benefits article (Article 17, as amended).

12.2    Additional Representations and Warranties of Licensor.  As of the Execution Date, Licensor further represents and warrants to Licensee that:
12.2.1    Annex A sets forth a true, complete and accurate list of all Licensed Patents existing as at the Effective Date;
12.2.2    it exclusively owns or Controls pursuant to an Upstream Agreement the Licensed Technology, without Encumbrance (except for Permitted Encumbrances);
12.2.3    it has the right to grant the License as purported to be granted hereunder;
12.2.4    [***], neither Licensor nor any of its Affiliates is a party to an Upstream Agreement pursuant to which Licensor or such Affiliate in-licenses any Patents or Know-How that are necessary or reasonably useful for the Exploitation of SEL-212 as contemplated by Licensor or its Affiliates as of the Execution Date;
12.2.5    (a) the Upstream Agreements are valid, binding, enforceable and in full force and effect, (b) neither Licensor nor, to Licensor’s knowledge, the counterparty to any such Upstream Agreement is in material breach thereof, and, to Licensor’s knowledge, no circumstances or grounds exist 

50

that would reasonably be expected to give rise to a claim of material breach or right of rescission, termination, revision, or amendment of any of the Upstream Agreements, including the execution, delivery and performance of this Agreement, and (c) Licensor has not received any written notice that it is in default (or with the giving of notice or lapse of time or both, would be in material default) under any Upstream Agreement;
12.2.6    to Licensor’s knowledge, the master Cell Bank for the Compound owned or controlled by 3SBio as of the Execution Date, and each working Cell Bank for the Compound Controlled by Licensor or owned or controlled by 3SBio, respectively, as of the Execution Date, were generated under cGMP standards and in accordance with applicable Laws, and have been stored in a manner consistent with cGMP and industry standards;
12.2.7    it has performed or had performed cGMP runs to generate material for use in human clinical trials;
12.2.8    the Licensed Patents existing as of the Execution Date are, to Licensor’s knowledge, valid and enforceable;
12.2.9    all registrations with and applications to Governmental Authorities in respect of the Licensed Patents or to Regulatory Authorities in respect of the Compound, ImmTOR or SEL-212 required to be made by Licensor or its Affiliates in connection with the Exploitation of the Products, or made at its or its Affiliates’ direction and under its or its Affiliates’ control, in connection with the Exploitation of the Product, are in full force and effect and Licensor or its relevant Affiliate has taken all actions required to maintain their validity, and (a) effectiveness (in the case of such registrations with and applications to Regulatory Authorities) or (b) enforceability (in the case of such registrations with and applications to Governmental Authorities in respect of the Licensed Patents);
12.2.10    it has taken commercially reasonable measures to protect the secrecy, confidentiality and value of the Licensed Know-How and, to Licensor’s knowledge, no event has occurred which has resulted in the unauthorized use or disclosure of any Licensed Know-How or which otherwise resulted in any Licensed Know-How falling into the public domain;
12.2.11    it has not received any written Claim alleging that Licensor’s or its Affiliates’ or licensee’s use of the Licensed Technology or Development of the Compound, ImmTOR and/or Product infringes or misappropriates any intellectual property rights of any Third Party (including any written Claim that Licensor must license or refrain from using any intellectual property rights of any Third Party in order to Exploit the Compound, ImmTOR and/or Product);
12.2.12    to Licensor’s knowledge: (a) no Third Party has infringed upon, misappropriated, or otherwise violated the Licensor’s rights in Licensed Technology; and (b) no facts exist as of the Execution Date which would form a reasonable basis for any claim of such infringement, misappropriation, or other violation;
12.2.13    no Claim is pending or, to Licensor’s knowledge, is threatened which challenges the legality, validity, enforceability, use, or ownership of any owned Licensed Technology or, to Licensor’s knowledge, in-licensed Licensed Technology;
12.2.14    except for routine patent prosecution proceedings in patent offices throughout the world, there is no pending or, or to Licensor’s knowledge, threatened, re-examination, opposition, interference, or litigation against or involving, or any written communication alleging that, any owned Licensed Patent, or, to Licensor’s knowledge, in-licensed Licensed Patent, is invalid or unenforceable anywhere in the world;

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12.2.15    to Licensor’s knowledge, there are no facts existing as of the Execution Date which would form a reasonable basis for any Claim of infringement, misappropriation, or other violation of any intellectual property rights of any Third Party existing as of the Execution Date related to the Licensed Technology or the Exploitation of the Compound, ImmTOR and / or the Product as contemplated by Licensor or its Affiliates as of the Execution Date;
12.2.16    to Licensor’s knowledge, having made reasonable inquiry, (a) the Development and Manufacture of the Compound, ImmTOR, and the Product (in the formulation in which it exists as of the Execution Date) in the Territory does not, and (b) the Exploitation of the Product (in the formulation in which it exists as of the Execution Date) in the Territory as contemplated by Licensor or its Affiliates as of the Execution Date will not, in each case ((a) and (b)) infringe upon or misappropriate, any intellectual property rights of any Third Party existing as of the Execution Date;
12.2.17    ImmTOR [***] conform to the statements in Annex G ([***]);
12.2.18    Licensor holds such Regulatory Approvals, and other permits, licenses, franchises, authorizations and clearances issued by the FDA or any other Regulatory Authority as are required in connection with the Development conducted to date by Licensor or its Affiliates of the Compound, ImmTOR or Product;
12.2.19    neither Licensor nor any of its Affiliates has received any warning letters or written correspondence from the FDA or any other Regulatory Authority requiring the termination, suspension or material modification of any clinical or pre-clinical studies or tests with respect to the Compound, ImmTOR or Product;
12.2.20    Licensor and its Affiliates have complied in all material respects with all applicable Law, including GCPs and GLPs, and all applicable Data Protection Laws, in connection with the Development conducted to date by Licensor or its Affiliates of the Compound, ImmTOR and the Product;
12.2.21    Licensor has provided Licensee with a complete and accurate copy of the most current version of the IND for SEL-212 held by Licensor;
12.2.22    the IND and all other Regulatory Filings filed by Licensor with respect to the Product were, at the time of filing, true, complete, and accurate in all material respects;
12.2.23    Licensor has disclosed all facts required to be disclosed with respect to the Compound, ImmTOR and Product to each applicable Regulatory Authority, and Licensor has filed with the applicable Regulatory Authority all required notices, reports, and other Regulatory Materials with respect to the IND held by Licensor for SEL-212;
12.2.24    Licensor has not received any notice from any Regulatory Authority or other Governmental Authority commencing or threatening withdrawal of any active IND for SEL-212 held by Licensor;
12.2.25    all Compound, ImmTOR and / or Product for clinical studies has been Manufactured and stored in material compliance with cGMP and all applicable Law;
12.2.26    Licensor is not as of the Execution Date in material dispute with any Third Party supplier responsible for the supply of the Compound, ImmTOR and / or SEL-212;
12.2.27    Licensor has not initiated a voluntary proceeding under any applicable bankruptcy code; and

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12.2.28    there is no involuntary proceeding under any applicable bankruptcy code pending against Licensor as of the Execution Date.

13.    SUPPLY

13.1    Supply for Existing Pivotal Trials.  
13.1.1    Subject to Section 4.3.7, if applicable, Licensor shall Manufacture and supply (or ensure the Manufacture and supply of) quantities of Product as necessary for the completion of the Licensor Development Activities. 
13.1.2    Licensor shall ensure that,
(a)    at the time of delivery of Product, [***] and ImmTOR, [***], in each case to the trial site for the Existing Pivotal Trials or relevant location:
(i)    the Product or ImmTOR, as applicable, shall have sufficient shelf life as is required to meet the requirements of the Existing Pivotal Trials until [***], the Product or ImmTOR, as applicable, shall have at least [***] months remaining shelf life, or such greater remaining shelf life as is required to meet the requirements of the Existing Pivotal Trials;
(ii)    the Product or ImmTOR, as applicable shall have been Manufactured, released, stored and supplied (for clarity, including all packaging and labelling) in compliance with: (i) the applicable Specifications; (ii) the relevant Quality Agreement; and (iii) all applicable Law, cGMP and GCP,
(iii)    it shall be solely responsible for obtaining and maintaining (or for ensuring that its relevant contract manufacturers obtain and maintain) all approvals of Regulatory Authorities that are required to Manufacture, release, store and supply the Product or ImmTOR, as applicable, in compliance with applicable Law and cGMP, for the Existing Pivotal Trials, and
(iv)    it shall be solely responsible for all Manufacturing, release, acceptance and release testing of the Product or ImmTOR, as applicable, for the Existing Pivotal Trials, and the subsequent handling, storage, transportation, warehousing and distribution thereof; and
(b)    without limiting the foregoing, at the time of delivery of Product to the trial site for the Existing Pivotal Trials, such Product shall have been packaged, labelled and released and stored (subject to Licensee’s obligation under Section 4.3.7 regarding the Compound, if applicable) in compliance with: (i) the applicable Specifications; (ii) the Licensor’s quality agreement with its relevant subcontractor(s); and (iii) all applicable Law, cGMP and GCP.

13.2    Supply Agreement. Without limiting Section 13.1, the Parties shall use good faith efforts to negotiate and enter into a Supply Agreement on the terms set out on Annex F on or before [***] days after the Effective Date or such longer period as may be mutually agreed by the Parties, pursuant to which, Licensor shall Manufacture, release and supply (or procure the Manufacture and supply of) commercial (and if required, clinical) quantities of ImmTOR or Product [***] (in accordance with all applicable Law, cGMP and GCP) to Licensee, its Affiliates and / or its Sublicensees in each case solely for use to Exploit the Product in accordance with the License.

13.3    Supply Price. Without limiting Section 13.2, the Parties agree that Product, [***] and, [***] ImmTOR, in each case, supplied for the Existing Pivotal Trials or under the Supply Agreement 

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shall be supplied at the Supply Price therefor.  Licensor shall solely bear all royalties and other amounts payable to Third Parties (other than under the Transferring Agreements following transfer to Licensee) in connection with its supply obligations under this Section 13, and Licensor warrants that the Supply Price accurately reflects the cost of manufacturing and supplying the Product and does not include any allocation of royalty or other amounts payable to Licensor’s licensors.  Licensor shall use Commercially Reasonable Efforts to decrease the Supply Price over time.

13.4    Second Source Supplier; Technology Transfer.
13.4.1    Notwithstanding Sections 13.1 and 13.2, at any time during the Term, Licensee may request in writing that the Parties discuss and mutually agree in good faith (each acting reasonably) via the JSC upon a Third Party contract manufacturer as a second source of supply of ImmTOR to Licensee solely for Licensee’s, its Affiliates’ and its Sublicensees’ Exploitation of the Products in the Field in the Territory as permitted under this Agreement (the “Second Source Supplier”).  Each Party hereby agrees not to unreasonably withhold, delay or condition its approval right in the mutual selection of the Second Source Supplier.
13.4.2    If a Second Source Supplier is selected in accordance with Section 13.4.1, at Licensee’s reasonable cost (provided Licensor shall provide Licensee with monthly updates regarding legal fees accrued to date and estimates of legal fees to completion), Licensor shall, in consultation with, and subject to prior approval by, Licensee, promptly enter into a commercially reasonable written agreement with such Second Source Supplier that:
(a)    will provide for the qualification by Licensor of the Second Source Supplier to Manufacture commercial quantities of ImmTOR under applicable Laws (including validation of the facility/ies of such Second Source Supplier) for Licensee, its Affiliates and its Sublicensees solely for Exploitation of the Products in the Field in the Territory as permitted under this Agreement;
(b)    will be dedicated to Manufacturing and supplying ImmTOR to Licensee, its Affiliates and its Sublicensees solely for Exploitation of the Products in the Field in the Territory as permitted under this Agreement and no other licensees of Licensor; and 
(c)    [***],
(such agreement, the “Licensee CMO Agreement”).  
13.4.3    Licensor shall keep Licensee reasonably informed as to the status of the Licensee CMO Agreement negotiations and give Licensee reasonable opportunity to comment on drafts (with Licensee being responsible for all costs and expenses it incurs with its review and comment).
13.4.4    [***], Licensor will engage and at all times manage in all respects the engagement of the Second Source Supplier, at Licensee’s cost. 
13.4.5    Licensor shall not materially breach or be in material default under any of its obligations under the Licensee CMO Agreement or take any other action, or omit or fail to take any action (including making necessary payments) that would result in early termination thereof or otherwise have an adverse effect on supply of ImmTOR to Licensee, its Affiliates and its Sublicensees solely for Exploitation of the Products in the Field in the Territory as permitted under this Agreement.
13.4.6    At any time after the execution of the Licensee CMO Agreement, Licensee may request in writing that Licensor complete, at Licensee’s cost, a Manufacturing technology transfer to the Second Source Supplier of the ImmTOR Manufacturing Process, which shall include Licensor cooperating with, and providing (or causing its relevant Affiliates or subcontractors to provide) all reasonable assistance, to the Second Source Supplier, including providing copies of all Licensed Know-

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How which is reasonably necessary to manufacture ImmTOR (including, for clarity, all reference standards, reagents and other materials reasonably necessary for such Manufacturing) in accordance with the specifications of ImmTOR as set forth in the Quality Agreement therefor and Regulatory Approval for the Product, and in compliance with cGMP and applicable Laws solely for Licensee’s, its Affiliates’ and its Sublicensees’ Exploitation of the Products in the Field in the Territory as permitted under this Agreement (the “Technology Transfer”).  
13.4.7    If Licensee makes a request for a Technology Transfer, Licensor will, (a) promptly complete the Technology Transfer to the Second Source Supplier, (b) provide (or cause to be provided by its relevant Affiliates or subcontractors) to the Second Source Supplier a reasonable level of technical assistance and consultation to support such Technology Transfer and provide reasonable assistance with the qualification of the Second Source Supplier’s Manufacturing facility/ies with applicable Regulatory Authorities, and (c) without limiting clause (b), provide for a certain percentage of the supply of ImmTOR solely for Licensee’s, its Affiliates’ and its Sublicensees’ Exploitation of the Products in the Field in the Territory as permitted under this Agreement to be supplied under the Supply Agreement via such Second Source Supplier.  In addition to qualifying the Second Source Supplier, Licensor shall be solely responsible for ensuring that the Second Source Supplier maintains all approvals of Regulatory Authorities that are required to Manufacture, store and supply ImmTOR, as applicable, in compliance with applicable Law and cGMP for Licensee, its Affiliates and its Sublicensees solely for Exploitation of the Products in the Field in the Territory as permitted under this Agreement. Licensee shall reimburse Licensor’s costs of such Technology Transfer at the FTE Rate and subject to a mutually agreed budget, provided that if Licensor plans, at the time of such Technology Transfer, to use (or does, within the [***] years following such Technology Transfer, so use) the Second Source Supplier to supply ImmTOR to Licensor, its Affiliates or other of its licensees, Licensee shall bear only (or shall be reimbursed) its pro rata share of such costs.
13.4.8     [***]
(a)    [***]. 
(b)    [***].

13.5    Cell Bank.  On Licensee’s request, Licensor shall transfer the working Cell Bank Controlled by the Licensor for the Manufacture of Compound to Licensee within [***] days following the date of Licensee’s request, and shall maintain (or have maintained) the same until such transfer, provided that Licensor may retain a sufficient part of the working Cell Bank as is required to be held by or on behalf of Licensor to enable Licensor to comply with its ongoing supply obligations hereunder.

13.6    Quality Agreements.  The Parties will use good faith efforts to negotiate and enter into the Quality Agreements (including a Quality Agreement for ImmTOR on the terms set out on Annex F) on or before the date that is [***] days after the Effective Date or such longer period as may be mutually agreed by the Parties.  The Parties acknowledge and agree that the Quality Agreements will govern all technical and quality matters relating to the Existing Pivotal Trials and the Manufacture and supply of clinical and commercial quantities of Product pursuant to the Supply Agreement as more particularly set out therein.  If there is a conflict between this Agreement and the Quality Agreements, the relevant Quality Agreement shall govern in relation to technical quality issues only.

14.    INDEMNIFICATION

14.1    Indemnification by Licensor.  Licensor shall indemnify, defend and hold harmless Licensee and its Affiliates, Sublicensees and each of their respective employees, officers, directors and agents (each a “Licensee Indemnitee”) from and against any and all liabilities, losses and damages (“Losses”) that result from any Claim made or brought against a Licensee Indemnitee by or on behalf of 

55

a Third Party, and any direct out-of-pocket costs and expenses (including reasonable attorneys’ fees) (“Litigation Costs”) incurred by a Licensee Indemnitee while investigating or conducting the defense of such Third Party Claim, in either case, solely to the extent such Claim is based on or arises out of:
14.1.1    [***] 
14.1.2    [***]
14.1.3    [***]
14.1.4    [***]
14.1.5    [***]
provided, however, that in the case of Sections 14.1.1 to 14.1.4 (inclusive), such indemnification right shall not apply to any Claims, Losses or Litigation Costs (a) to the extent directly attributable to the gross negligence or willful misconduct of a Licensee Indemnitee or Licensee’s breach of this Agreement, or (b) for which Licensee is obligated to indemnify Licensor under Section 14.2.

14.2    Indemnification by Licensee.  Licensee shall indemnify, defend and hold harmless Licensor and its Affiliates and each of their respective employees, officers, directors and agents (each an “Licensor Indemnitee”) from and against any and all Losses that result from any Claim made or bought against an Licensor Indemnitee by or on behalf of such Third Party, and any Litigation Costs incurred by an Licensor Indemnitee while investigating or conducting the defense of such Third Party Claim, in either case, solely to the extent such Claim is based on or arises out of:
14.2.1    [***]
14.2.2    [***]
14.2.3    [***];
provided, however, that such indemnification right shall not apply to any Claims, Losses or Litigation Costs (a) to the extent directly attributable to the gross negligence or willful misconduct of a Licensor Indemnitee or Licensor’s breach of this Agreement, or (b) for which Licensor is obligated to indemnify Licensee under Section 14.1.

14.3    Indemnification Procedures.
14.3.1    All indemnification claims in respect of a Licensor Indemnitee shall be made solely by Licensor and all indemnification claims in respect of a Licensee Indemnitee shall be made solely by Licensee.
14.3.2    Subject to Section 14.3.1, promptly after receipt by a Party seeking indemnification under this Section 14 (an “Indemnitee”) of notice of any pending or threatened Claim against it by a Third Party, such Indemnitee shall give written notice thereof to the Party from whom the Indemnitee is entitled to seek indemnification pursuant to this Section 14 (the “Indemnifying Party”); provided that the failure so to notify the Indemnifying Party shall not relieve it of any liability that it may have to any Indemnitee hereunder, except to the extent the Indemnifying Party demonstrates that it is materially prejudiced thereby, and in no event shall the Indemnifying Party be liable for any Losses to the extent resulting from any delay of the Indemnitee in providing such notice.
14.3.3    The Indemnitee:

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(a)    shall not at any time admit liability or otherwise settle or compromise, or attempt to settle or compromise, any such matter (or any aspect of it) except on the Indemnifying Party’s express written instructions;
(b)    shall give the Indemnifying Party sole conduct of the defense, negotiation or settlement of any such matter upon request (except that the Indemnitee can participate in such defense or consent to such settlements as and to the extent described below) at the Indemnifying Party’s sole cost;
(c)    may participate, if the Indemnifying Party assumes such defense, in any such matter through counsel of its own choice at such Indemnitee’s sole cost and expense; provided, however, that the Indemnifying Party shall pay the fees and expenses of such separate counsel if the interests of the Indemnified Party and Indemnitee with respect to any such matter are sufficiently adverse to prohibit the representation by the same counsel of both the Indemnifying Party and the Indemnitee under applicable Laws, ethical rules, or equitable principles;
(d)    shall act in accordance with the Indemnifying Party’s reasonable instructions, and give the Indemnifying Party such assistance as it may reasonably require in the conduct of any defense, negotiation or settlement of any such matter, and the Indemnifying Party shall reimburse the reasonable and verifiable out-of-pocket costs and expenses incurred by the Indemnitee; and
(e)    shall take all reasonable steps to mitigate any Losses which it may incur as a result of such matter.
14.3.4    The Indemnifying Party shall not agree to any settlement of, or the entry of any judgment arising from, any indemnification claim without the prior written consent of the Indemnitee (such consent not to be unreasonably withheld, delayed or conditioned); provided, however, that the consent of the Indemnitee shall not be required with respect to any such settlement or judgment if the Indemnifying Party or its insurer agrees in writing to pay or cause to be paid any amounts payable pursuant to such settlement or judgment and includes a full release of the Indemnitee from further liability or if such settlement or judgment imposes no admission of liability by or other obligation on the Indemnitee that will not be assumed and performed in full by the Indemnifying Party.

14.4    Insurance.  Each of Licensor and Licensee shall have and maintain such type and amounts of liability insurance covering its activities under this Agreement as is normal and customary in the pharmaceutical industry generally for parties similarly situated.  Each Party shall, upon request of the other Party, provide the requesting Party with a copy of the foregoing policies of insurance, along with any amendments and revisions thereto.

15.    LIMITATION OF LIABILITY 

15.1    LIMITS.  [***] AND SOLELY TO THE EXTENT PERMITTED BY APPLICABLE LAWS, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY UNDER ANY CIRCUMSTANCES OR ANY LEGAL OR EQUITABLE THEORY, WHETHER IN CONTRACT, STRICT LIABILITY OR OTHERWISE, FOR ANY LOST PROFITS OR SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OR ANY LIMITED REMEDY.

15.2    KNOWLEDGE.  THE RIGHTS OF LICENSEE TO INDEMNIFICATION OR ANY OTHER REMEDY UNDER THIS AGREEMENT SHALL NOT BE AFFECTED, LIMITED OR DEEMED WAIVED BY REASON OF ANY KNOWLEDGE THAT LICENSEE (OR ANY OF ITS AFFILIATES OR REPRESENTATIVES) MAY HAVE ACQUIRED, OR COULD HAVE ACQUIRED 

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THAT ANY SUCH REPRESENTATION OR WARRANTY IS, WAS OR MIGHT BE INACCURATE, WHETHER BEFORE OR AFTER THE EXECUTION DATE, NOR BY ANY INVESTIGATION OR DILIGENCE BY LICENSEE (OR ANY OF ITS AFFILIATES OR REPRESENTATIVES).  LICENSOR HEREBY ACKNOWLEDGES THAT, REGARDLESS OF ANY INVESTIGATION MADE (OR NOT MADE) BY OR ON BEHALF OF LICENSEE (OR ANY OF ITS AFFILIATES OR REPRESENTATIVES), AND REGARDLESS OF THE RESULTS OF ANY SUCH INVESTIGATION, THE LICENSEE HAS ENTERED INTO THIS AGREEMENT IN EXPRESS RELIANCE ON THE REPRESENTATIONS AND WARRANTIES OF THE LICENSOR MADE IN THIS AGREEMENT.

16.    TERM AND TERMINATION

16.1    Term.  The term of this Agreement shall begin upon the Effective Date and shall continue in full force and effect, unless terminated as hereinafter provided in this Section 16, on a Product-by-Product basis until the date on which the Royalty Term has expired in each country in the Territory for such Product and will finally expire upon the expiration of the last-to-expire Royalty Term (the “Term”).

16.2    Termination of Agreement for Material Breach.  Either Party may terminate this Agreement for material breach of this Agreement by the other Party by giving [***] days’ written notice to the breaching Party (specifying in reasonable detail the basis for such termination), unless the breaching Party has cured such breach or default prior to the expiration of such cure period, or, if such breach is not susceptible to cure within such cure period even with the use of Commercially Reasonable Efforts, the non-breaching Party’s right to termination shall be suspended only if and for so long as the breaching Party has provided to the non-breaching Party a reasonable written plan, calculated to effect a cure of such breach, and the breaching Party commits to and is diligently performing such plan.

16.3    Termination of Agreement for Bankruptcy.  Either Party may terminate this Agreement upon the occurrence of one or more of the following:
16.3.1    immediately upon written notice to the other Party in the event the other Party initiates a voluntary proceeding under any applicable bankruptcy code; or
16.3.2    immediately upon written notice to the other Party in the event the other Party becomes the subject of an involuntary proceeding under any applicable bankruptcy code and such proceeding is not dismissed or stayed within [***] days of its commencement.

16.4    Termination of Agreement for Patent Challenge.  If Licensee or any of its Affiliates brings, or actively supports a Third Party’s efforts to bring, an action challenging the validity, patentability or enforceability of any Licensed Patents (a “Patent Challenge”), Licensor may terminate this Agreement by giving [***] days’ written notice to Licensee, unless Licensee has filed a motion to dismiss with prejudice such action or caused such action to be dismissed with prejudice within [***] days following receipt of such notice.  Provided, however, that the foregoing shall not apply to situations where (a) Licensee or such Affiliate is to participate in such patent challenge pursuant to a subpoena or court order or participates in a proceeding that is initiated by a patent office and not at the instigation of Licensee or such Affiliate, (b) any assertion by Licensee or such Affiliate relating to validity, patentability, priority, construction, non-infringement, inventorship, ownership or enforceability as a defense in any legal proceeding, administrative proceeding or arbitration brought by Licensor or 3SBio or their licensees or assignees asserting infringement against Licensee or such Affiliate, or (c) any challenge brought by a Third Party which subsequently becomes an Affiliate of Licensee provided such challenge was initiated at least one (1) month before the signing of the definitive document(s) whereby such Third Party became an Affiliate of Licensee and the Licensee causes such Third Party to file a motion to dismiss with prejudice such challenge within [***] days after such Third Party becomes an Affiliate of Licensee.  For clarity, this Section 16.4 shall not apply to arguments made by Licensee or its Affiliates that distinguish the 

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inventions claimed in Licensed Patents from those claimed in the patent applications owned or controlled by Licensee or any of its Affiliates in the ordinary course of ex parte prosecution of such patent applications.

16.5    Termination of Agreement by Licensee.  Licensee may terminate this Agreement upon not less than one hundred and eighty (180) days’ written notice to Licensor for convenience.

16.6    Effects of Termination by Licensor for Cause or by Licensee for Convenience.  Upon termination of this Agreement by Licensor pursuant to Section 16.2, 16.3 or 16.4, or by Licensee pursuant to Section 16.5, which shall apply as a lead-in to each of the subsections of this Section 16.6 below:
16.6.1    Termination of License.  The License and any rights of use or access granted to Licensee under this Agreement will terminate.
16.6.2    [***].
(a)    At Licensor’s request delivered no later than [***] days after the effective date of termination, effective upon such effective date of termination of this Agreement, Licensee [***].
(b)    LICENSOR AGREES AND ACKNOWLEDGES THAT [***] ITS AND THEIR SUBLICENSEE’S [***].
(c)    [***].
(d)    [***].
16.6.3    [***].
16.6.4    Right to Sell-Off.  Licensee and its Affiliates and Sublicensees shall have the non-exclusive right to sell off any Product within their Control for a period not to exceed [***] months from the date of termination, subject to payment of all applicable Royalty obligations under Section 6.4. 
16.6.5    Cooperation.  Without limiting either Party’s obligations under this Section 16.6, the Parties will reasonably cooperate to effect a smooth transition following the effective date of termination of this Agreement.
16.6.6    Continuation of Supply.  [***].
16.6.7    [***].
16.6.8    [***].
16.6.9    Return of Confidential Information.  [***], each Party will promptly destroy or return to the other Party all of such other Party’s Confidential Information that was provided by or on behalf of such other Party hereunder that is in the possession or control of such Party (or any of its Affiliates), except that such Party will have the right to retain copies of Confidential Information of such other Party to the extent required for legal and archival purposes.
16.6.10    [***].
16.6.11    Dissolution of JSC.  The JSC and, if applicable, any subcommittees it formed will be dissolved as of the effective date of such termination, provided that, for any surviving provisions requiring action or decision by the JSC or any such subcommittees or an Executive Officer, each Party 

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will appoint representatives to act as its JSC and subcommittee members or Executive Officer, as applicable.
16.6.12    Termination of Rights and Obligations.  Except as set forth in this Section 16.6 and Section 16.9, as of the effective date of such termination, all rights and obligations of the Parties under this Agreement will terminate.
16.6.13    Future Assurances.  Each Party will execute all documents, or cause to be executed all documents, and take, or cause to be taken, all such further actions as may be reasonably requested by the other Party in order to give effect to the foregoing clauses.

16.7    Effect of Termination by Licensee for Cause.  Upon termination of this Agreement by Licensee pursuant to Section 16.2 or Section 16.3, which shall apply as a lead-in to each of the subsections of this Section 16.7 below:
16.7.1    Continuation of License.  At Licensee’s option, exercised by providing written notice to Licensor prior to the effective date of such termination (the exercise of which Licensee may revoke at any time thereafter by providing written notice to Licensor), the License and other rights of use or access granted by Licensor to Licensee under the Licensed Technology will remain in effect in accordance with their respective terms and become perpetual and irrevocable, subject to, (a) if Licensee terminates pursuant to Section 16.3, (i) Licensee’s continued compliance with its diligence obligations set forth in Sections 4.1.2 and 5.1.2 and (ii) Licensee’s continuing obligation to make milestone and royalty payments under Section 6 in the amounts payable as of the effective date of such termination (subject to any right of set-off under Section 6.5), or (b) [***], and, in each case of (a) and (b), to pay any payments owed to Licensor’s licensors under any Upstream Agreements.  
16.7.2    Return of Confidential Information.  Except in the case of Licensee for any Confidential Information of Licensor that is the subject of its continuing license pursuant to Section 16.7.1, each Party will promptly destroy or return to the other Party all of such other Party’s Confidential Information that was provided by or on behalf of such other Party hereunder that is in the possession or control of such Party (or any of its Affiliates), except that such Party will have the right to retain copies of Confidential Information of such other Party to the extent required for legal and archival purposes.
16.7.3    Dissolution of JSC.  The JSC and, if applicable, any subcommittees it formed will be dissolved as of the effective date of such termination, provided that, for any surviving provisions requiring action or decision by the JSC or any such subcommittees or an Executive Officer, each Party will appoint representatives to act as its JSC and subcommittee members or Executive Officer, as applicable.
16.7.4    Termination of Rights and Obligations.  Except as set forth in this Section 16.7 and Section 16.9, as of the effective date of such termination, all rights and obligations of the Parties under this Agreement will terminate.
16.7.5    Further Assurances.  Licensor will execute all documents, or cause to be executed all documents, and take, or cause to be taken, all such further actions as may be reasonably requested by Licensee in order to give effect to the foregoing clauses.

16.8    Licensor’s Insolvency. Except to the extent that Licensor is subject to a case under the Bankruptcy Code and the following conflicts with Section 365(n) of the Bankruptcy Code, upon Licensor entering into any voluntary or involuntary bankruptcy, insolvency or restructuring proceeding during the Term of this Agreement, and notwithstanding any attempted termination of this Agreement by any trustee, administrator or executor of Licensor or an applicable bankruptcy court: (i) all rights and licenses herein granted to Licensee shall continue in full force and effect in perpetuity provided Licensee continues to comply with its diligence obligations set forth in Sections 4.1.2 and 5.1.2 and to pay any milestone 

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payments and Royalties otherwise due hereunder (subject to any right of set-off hereunder); and (ii) Licensor shall have, to the extent required by applicable bankruptcy laws in order to maintain Licensee’ license rights hereunder, no further obligations under this Agreement other than to not interfere with Licensee’s license rights hereunder.  The Parties agree that the terms of this Agreement are fair and reasonable and have been negotiated in an arms-length transaction between unrelated parties with each Party represented by legal counsel.  If any provision herein is deemed onerous or otherwise unenforceable by any applicable bankruptcy court, the Parties shall use good faith efforts to amend the Agreement (e.g., removing such onerous provision) so as to avoid any consequences thereof under applicable bankruptcy laws.

16.9    Survival. In addition to any provisions expressly stated to survive expiration or early termination of this Agreement and except as expressly provided herein, Sections 1, 2.2.2 through 2.2.14 (in each case of 2.2.2 through 2.2.14 solely in case of Licensee electing to retain the License pursuant to Section 16.7.1 [***]), 2.3 (solely in case of Licensee electing to retain the License pursuant to Section 16.7.1), 2.6 (solely in case of Licensee electing to retain the License pursuant to Section 16.7.1), 2.8 (except in the case of termination by Licensor pursuant to Section 16.2, 16.3 or 16.4 or by Licensee pursuant to Section 16.5, and in each case following expiry of the period set forth in Section 16.6.4), 2.9, 2.11 [***], 4.3.6 (only until the expiry of the period required by applicable Law), 4.3.9 (only until the expiry of the period required by applicable Law), 6.6, 6.7, 7 (only to the extent stated therein with respect to Section 7.1 and 7.2), 8.4 (solely in case of Licensee electing to retain the License pursuant to Section 16.7.1), 8.6 (until the longer of the expiry of the period required by applicable Law and the expiry or earlier termination of the Safety Agreement), 8.7, 9.1 and 9.2 (in each case 9.1 and 9.2 solely: (i) [***], or (ii) in case of Licensee electing to retain the License pursuant to Section 16.7.1), 9.4 (only in the case of (i) expiration of this Agreement or (ii) Licensee electing to retain the License pursuant to Section 16.7.1 and for each ((i) and (ii)) in respect of pending or contemplated (at the time of such expiration or termination) litigation), 9.5 (only in the case of (i) expiration of this Agreement Licensee electing to retain the License pursuant to Section 16.7.1 and (ii) in respect of pending Third Party Infringement Claims), 9.6 (only in the case of Licensee electing to retain the License pursuant to Section 16.7.1), 9.7, 9.8 (only in the case of Licensee electing to retain the License pursuant to Section 16.7.1), 9.10, 10, (only to the extent stated therein), 11, 13.4.8 (only to the extent stated therein), 14, 15, 16.6, 16.7, 16.8, 16.9, 17 and 19, and Section 6 (to the extent any accrued rights to payment arose prior to, or are intended to, survive any expiration or early termination of this Agreement).

17.    DISPUTE RESOLUTION

17.1    Governing Law.  This Agreement shall be governed by and construed in accordance with the applicable Laws of the State of New York, excluding any conflicts or choice of applicable Laws rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive applicable Laws of another jurisdiction.

17.2    Dispute Resolution.
17.2.1    Resolution by Executive Officers.  Subject to Section 19.6 and except as otherwise expressly set forth in this Agreement, including Section 3.2, in the event of any disagreement, controversy, dispute or claim arising out of, in connection with, or in relation to the interpretation, performance, or alleged breach of this Agreement (the “Dispute”), prior to instituting any proceeding on account of such Dispute, the Parties shall attempt in good faith to settle such Dispute first by referral of such matters to the JSC.  After attempted resolution of any Dispute by the JSC in accordance, the Dispute shall be referred to the Executive Officers of the Parties in writing by either Party, who will use good faith efforts to resolve such matter within [***] days after the JSC’s submission of such matter to such Executive Officers, which good faith efforts will include at least one (1) meeting between such Executive Officers within [***] Business Days after such submission.  Any final decision mutually agreed to by the Executive Officers shall be set forth in writing and be conclusive and binding on the Parties.  In the 

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event said Executive Officers are unable to resolve such Dispute or agree upon a mechanism to resolve such Dispute within [***] days of the first written request for dispute resolution under this Section 17.2.1, then the Parties shall resolve all such Disputes in accordance with Section 17.2.2.
17.2.2    Litigation.  Except in relation to a matter expressly stated to be referred to Expedited Arbitration hereunder, any unresolved Dispute that was subject to Section 17.2.1 shall be brought exclusively in a court of competent jurisdiction, federal or state, located in New York, New York, and in no other jurisdiction.
17.2.3    Jurisdiction; Waiver of Trial by Jury.  Subject to Section 19.6, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of New York and the United States District Court for the Southern District of New York for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts.  THE PARTIES IRREVOCABLY AND UNCONDITIONALLY WAIVE THEIR RIGHT TO A JURY TRIAL IN CONNECTION WITH ANY LITIGATION ARISING OUT OF OR RELATING TO THIS PARTICIPATION AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.
17.2.4    Venue.  The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of the State of New York or in the United States District Court for the Southern District of New York, and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.
17.2.5    Service.  Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 19.8 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.
17.2.6    Confidentiality.  Any and all non-public activities conducted under Section 17.2, including any and all non-public proceedings and decisions under Section 17.2.2, shall be deemed Confidential Information of each of the Parties, and shall be subject to the terms of Section 10.
17.2.7    Expedited Arbitration.  If a Party exercises its rights under this Agreement to refer a Dispute to expedited arbitration (an “Expedited Dispute”), then the Parties will follow the expedited dispute resolution process in this Section 17.2.7 (and not the dispute resolution process in Section 17.2.1 of this Agreement) (“Expedited Arbitration”).  The Parties agree and acknowledge that any good faith dispute under Expedited Arbitration will not be deemed to be a material breach of this Agreement.  The Expedited Dispute will be submitted to fast track, binding arbitration in accordance with the following:
(a)    An Expedited Arbitration shall be administered by the American Arbitration Association (“AAA”) in accordance with its International Arbitration Rules, as amended by this Section 17.2.7, and judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. The place of arbitration shall be New York, New York. The award shall be rendered within [***] Business Days after the appointment of the arbitrator, unless the arbitrator determines that the interest of justice requires that such limit be extended. The language of the arbitration shall be English.  There shall be one (1) arbitrator.  If the Parties are unable to agree on an arbitrator within [***] Business Days from the initiation of the arbitration, then the Parties will request that the AAA select the arbitrator.  The arbitrator shall have at least ten (10) years of experience in disputes involving the pharmaceutical and life sciences industries, including the valuation of biopharmaceutical intellectual property and the conduct of research, development, and commercialization collaborations.  The cost of the arbitration will be borne equally by the Parties, and each Party shall bear its own costs 

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and attorney’s and witnesses’ fees and associated costs and expenses.  Except in a proceeding to enforce the results of the arbitration or as otherwise required by applicable Laws, neither Licensee nor Licensor nor any arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written agreement of Licensee and Licensor.
(b)    Within [***] Business Days after the appointment of the arbitrator, each Party will provide the arbitrator with a proposal and written memorandum in support of its position regarding the Expedited Dispute, as well as any documentary evidence it wishes to provide in support thereof (not to exceed thirty (30) pages) (each a “Proposal”) and the arbitrator will provide each Party’s Proposal to the other Party after it receives it from both Parties.
(c)    Within [***] Business Days after a Party submits its Proposal, the other Party will have the right to submit a rebuttal memorandum (not to exceed fifteen (15) pages), if any, to the arbitrator and the other Party. If requested by the arbitrator, the Parties will make oral submissions to the arbitrator based on such Party’s Proposal.  
(d)    Within [***] Business Days after the receipt by the arbitrator of both Parties’ written submissions (or expiration of the [***] Business Day period if any Party fails to submit a response), the arbitrator will issue a final award in writing, stating its reasoning, provided that the arbitrator will select one of the Parties’ Proposals. The decision of the arbitrator will be the sole, exclusive, binding and non-appealable remedy between them regarding the dispute referred to Expedited Arbitration. 
17.2.8    Tolling.  The Parties agree that all applicable statutes of limitation and time based defenses (such as estoppel and laches), as well as all time periods in which a Party must exercise rights or perform obligation hereunder, will be tolled once the dispute resolution procedures set forth in this Section 17.2 have been initiated and for so long as they are pending, and the Parties will cooperate in taking all actions reasonably necessary to achieve such a result.  In addition, during the pendency of any Dispute under this Agreement initiated before the end of any applicable cure period, including under Section 16.2, (a) this Agreement will remain in full force and effect, (b) the provisions of this Agreement relating to termination for material breach with respect to such Dispute will not be effective, (c) the time periods for cure under Section 16.2 as to any termination notice given prior to the initiation of arbitration will be tolled, (d) any time periods to exercise rights or perform obligations will be tolled, and (e) neither Party will issue a notice of termination pursuant to this Agreement based on the subject matter of the arbitration, until the arbitral tribunal has confirmed the material breach and the existence of the facts claimed by a Party to be the basis for the asserted material breach; provided that if such breach can be cured by (i) the payment of money, then the defaulting Party will have an additional [***] calendar days within its receipt of the arbitral tribunal’s decision to pay such amount, or (ii) the taking of specific remedial actions, then the defaulting Party will have a reasonably necessary period to diligently undertake and complete such remedial actions within such reasonably necessary period or any specific timeframe established by such arbitral tribunal’s decision before any such notice of termination can be issued.  Further, with respect to any time periods that have run during the pendency of the Dispute, the applicable Party will have a reasonable period of time or any specific timeframe established by such arbitral tribunal’s decision to exercise any rights or perform any obligations affected by the running of such time periods.

18.    HSR FILINGS AND CLOSING

18.1    HSR Filings.  If required by Applicable Laws, after the execution of this Agreement, both Parties shall promptly, and in no less than [***] Business Days, file, the appropriate notices under the Hart Scott Rodino Antitrust Improvements Act (“HSR Act”).  The Parties shall promptly make required filings to obtain clearance under the HSR Act for the consummation of this Agreement and the transactions contemplated hereby, use reasonable efforts to obtain such clearance, and shall keep each other apprised of the status of any communications with, and any inquiries or requests for additional information from, the United States’ Federal Trade Commission (“FTC”) and Department of Justice (“DOJ”) and shall 

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comply promptly with any such inquiry or request; provided, however, neither Party shall be required to consent to the divestiture or other disposition of any of its assets or the assets of its Affiliates or to consent to any other structural or conduct remedy, and each Party and its Affiliates shall have no obligation to contest, administratively or in court, any ruling, order or other action of the FTC or DOJ or any Third Party with respect to the transactions contemplated by this Agreement.  Each Party shall be responsible for paying its own costs and expenses (including legal and consultants’ fees) incurred in connection with obtaining clearance of the transactions contemplated hereby from the FTC and the DOJ [***].  Each of the Parties hereto will furnish to the other such necessary information and reasonable assistance as the other may request in connection with the preparation of any required filings or submissions and will cooperate in responding to any inquiry from the FTC or DOJ and to any requests for additional information at the earliest practicable date, including promptly informing the other Party of such inquiry, consulting in advance before making any presentations or submissions to the FTC or DOJ, and supplying each other with copies of all material correspondence, filings or communications between either party and either the FTC or DOJ with respect to this Agreement.  Such information can be shared on an outside counsel basis or subject to other restrictions to the extent deemed necessary or advisable by counsel for the disclosing Party.  To the extent practicable and as permitted by the FTC or DOJ, each Party hereto shall permit representatives of the other Party to participate in material substantive meetings (whether by telephone or in person) with the FTC or DOJ.  Neither Party shall commit to or agree with the FTC or DOJ to withdraw its filing and refile under the HSR Act without the prior written consent of the other (such consent not to be unreasonably withheld, conditioned or delayed).  In the event the Parties determine that HSR filings are required, the Effective Date shall not be deemed to have occurred and this Agreement (other than this Section 18 and Section 10) shall not be binding until the HSR Clearance Date.  Notwithstanding any other provisions of this Agreement to the contrary, either Party may terminate this Agreement effective upon notice to the other Party if the HSR Clearance Date has not occurred on or before the date that is one hundred and eighty (180) days after the Parties make their respective HSR filings.

19.    MISCELLANEOUS

19.1    No Benefit to Third Parties.  Except under Section 14, the covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Persons.

19.2    Relationship of the Parties.  It is expressly agreed that Licensor, on the one hand, and Licensee, on the other hand, shall be independent contractors and that the relationship between the Parties under this Agreement shall not constitute a partnership, joint venture or agency.  Neither Licensor, on the one hand, nor Licensee, on the other hand, shall have the authority to make any statements, representations or commitments of any kind or to take any action that will be binding on the other Party without the prior written consent of the other Party to do so.  All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such first Party.

19.3    Unenforceability.  If any provision of this Agreement is held or determined to be illegal, invalid, void or unenforceable under any present or future applicable Laws by a final decision of a court of competent jurisdiction on the merits from which no appeal can be taken, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid, void or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, void or unenforceable provision or by its severance therefrom, and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid, void or unenforceable provision as may be possible and reasonably acceptable to the Parties.

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19.4    Waiver and Non-Exclusion of Remedies.  Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition.  The waiver by either Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.  The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by applicable Laws or otherwise available except as expressly set forth herein.

19.5    Assignment; Securitization.
19.5.1    Assignment.
(a)    Except as expressly provided hereunder, neither Party may assign, delegate or otherwise transfer this Agreement or its rights and obligations hereunder except with the prior written consent of the other Party, not to be unreasonably withheld, conditioned or delayed.  Notwithstanding the foregoing, either Party shall have the right to assign this Agreement (in whole or in part) without the other Party’s prior written consent to any of its Affiliates, successors in interest or acquirers of all or substantially all of its assets relating to the Licensed Technology or the Product, including any successor in interest by way of any merger, sale of assets, reincorporation or other reorganization; provided that such Affiliate, successor in interest or acquirer assumes in writing all of such Party’s obligations under this Agreement or part hereof.  An assignment to an Affiliate shall terminate, and all rights so assigned will revert to the assigning Party, if and when such Affiliate ceases to be an Affiliate of the assigning Party.
(b)    Licensor covenants and agrees that it shall not assign any of the Licensed Technology to any Third Party unless the obligations under this Agreement are also assigned to and assumed by such Third Party in writing and, absent a novation agreed and executed by the Parties, the assigning Party shall continue to be liable to the non-assigning Party for any breaches of this Agreement by the Affiliate, successor in interest or acquirer.
(c)    Any attempted assignment, delegation or transfer of this Agreement or any rights or obligations hereunder by either Party without the prior written consent of the other Party, other than in accordance with this Section 19.5.1, shall be void and of no effect.  Subject to the preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and permitted assigns, provided that the assigning Party shall remain responsible for all of its obligations hereunder notwithstanding any such assignment.
19.5.2    Securitization.  Notwithstanding anything to the contrary in this Section 19.5 or elsewhere in this Agreement, Licensor may assign to a Third Party which is not in the business of exploiting pharmaceutical products the right to receive the milestone payments under Sections 6.2 and 6.3 and the Royalty payments under Section 6.4 (such assignment, a “Securitization Transaction”) without the prior written consent of Licensee, provided that upon making such assignment: (a) such Third Party shall not have any rights or benefits directly under this Agreement, including any right to directly enforce its terms with Licensee; (b) Licensee shall have no obligation to pay amounts due hereunder to more than one Person, (c) Licensee’s right pursuant to Section 19.4 to waive the terms of this Agreement will not be subject to the consent of such Third Party, and (d) Licensor shall as soon as reasonably practicable following the completion of such Securitization Transaction provide Licensor with a copy of the agreement executed by Licensor with the relevant Third Party (which copy may be redacted to remove provisions which are not necessary to ensure compliance with this Section 19.5.2). In connection with a contemplated or consummated Securitization Transaction, Licensor may disclose to such Third Party the royalty reports contemplated under Section 6.6 and, to the extent milestone payments are proposed to be included in the Securitization Transaction, the notices on achievement of Development Milestone Events contemplated 

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under Section 6.2, without the prior written consent of Licensee, to the extent reasonably necessary to enable such Third Party to evaluate the Securitization Transaction opportunity and to allow such Third Party to exercise its rights with respect to such Securitization Transaction (provided that such Third Party is under obligations of confidentiality and non-use with respect to Confidential Information included in such reports that are no less stringent than the terms of Section 10).

19.6    Injunctive Relief.  Each of the Parties agrees that if certain obligations under this Agreement are not performed in accordance with their specific terms or are otherwise breached, (a) severe and irreparable damage would occur, (b) no adequate remedy at law would exist, and (c) damages would be difficult to determine.  Each of the Parties agrees that, in such case, the injured Party shall be authorized and entitled to obtain from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, as well as any other relief permitted by applicable law, and the breaching Party hereby waives: (i) any requirement that such Party post bond as a condition for obtaining any such relief and (ii) any defenses in any action for specific performance, including the defense that a remedy at law would be adequate.

19.7    English Language.  This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language.  Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.

19.8    Notices.  Every notice, election, demand, consent, request, approval, report, offer, acceptance, certificate, or other communication required or permitted under this Agreement or by applicable Law shall be in writing and shall be deemed to have been delivered and received (a) when personally delivered, (b) on the fifth (5th) Business Day after which sent by registered or certified mail, postage prepaid, return receipt requested, (c) on the date on which transmitted by email as a PDF attachment (with transmission confirmed) (provided that, on that same date, a copy of such notice is sent by registered or certified mail, postage prepaid, return receipt requested), or (d) on the third (3rd) Business Day after the Business Day on which deposited with a regulated public carrier (e.g., Federal Express) for overnight delivery (receipt verified), freight prepaid, addressed to the Party for whom intended at the mailing address or email set forth below, or such other mailing address or facsimile number, notice of which is given in a manner permitted by this Section 19.8.
For Licensor:
Selecta Biosciences Inc. 
 
65 Grove Street
Watertown, MA 02472 
Attn: General Counsel 
[***] 

With a copy to (which shall not constitute notice):
Gibson, Dunn & Crutcher LLP
555 Mission Street
San Francisco, CA 94105
Attention: Ryan Murr and Karen Spindler
[***]

For Licensee:

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Swedish Orphan Biovitrum AB (publ) 
SE-112 76 Stockholm, Sweden 
Attn: General Counsel 
[***]
With a copy to (which shall not constitute notice):
Latham & Watkins LLP 
12670 High Bluff Drive 
San Diego, CA 92130 
[***]

19.9    Force Majeure. If and to the extent that either Party is prevented, delayed or materially hindered by a Force Majeure Event from performing any of its obligations under this Agreement and promptly so notifies the other Party, specifying the matters constituting the Force Majeure Event, then the Party so affected shall be relieved of liability to the other for failure to perform or for delay in performing such obligations (as the case may be), but shall nevertheless use Commercially Reasonable Efforts to resume full performance thereof.  The affected Party shall undertake Commercially Reasonable Efforts necessary to cure or to mitigate the effects of such Force Majeure Event.  In addition, neither Licensor nor Licensee shall be obligated to make any payments for any part of any services not performed as a result of any Force Majeure Event.

19.10    Headings.  The captions to the Sections hereof are not a part of this Agreement and shall not be used to inform interpretation of this Agreement, but are merely guides or labels to assist in locating and reading the several Sections hereof.

19.11    Set Off.  Notwithstanding anything to the contrary in this Agreement, Licensee shall have a right to set-off any Royalties or other amounts due under this Agreement to Licensor against any damages incurred by Licensee and/or its Affiliates and awarded pursuant to an Order relating to Licensor’s breach of this Agreement.

19.12    Costs and Expenses.  Except as otherwise expressly set forth in this Agreement, each Party shall bear its own costs and expenses in performing its obligations under this Agreement.

19.13    Further Assurance.  Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.

19.14    Amendment.  No amendments, changes, modifications, supplementation, waivers or alterations of the terms and conditions of this Agreement shall be binding upon either Party hereto unless in writing and executed by both Parties.

19.15    Counterparts.  This Agreement may be executed in counterparts and each such counterpart shall be deemed an original instrument, but all such counterparts together shall constitute but one agreement.  Delivery of an executed counterpart of a signature page of this Agreement by electronic transmission shall be effective as delivery of a manually executed original counterpart of this Agreement.

19.16    Entire Agreement.  This Agreement, together with the Annexes and Schedules hereto and the other agreements and documents delivered in connection with the transactions contemplated hereby, contain the entire understanding between the Parties relating to the subject matter hereof and 

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supersedes any and all prior agreements, understandings and arrangements, whether written or oral, between the Parties hereto relating to such subject matter and to the extent relating to the Products.
[SIGNATURE PAGE FOLLOWS]

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IN WITNESS WHEREOF, the Parties hereto have executed this LICENSE AND DEVELOPMENT AGREEMENT as of the Execution Date.
	
		
	SELECTA BIOSCIENCES INC.

	 
	 

	By:
	/s/ Carsten Brunn, Ph.D.

	Name:
	Carsten Brunn, Ph.D.

	Title:
	President and Chief Executive Officer

	 
	 

	 
	 

	SWEDISH ORPHAN BIOVITRUM AB (PUBL)

	By:
	/s/ Guido Oelkers

	Name:
	Guido Oelkers

	Title:
	CEO

	 
	 

	 
	 

	By:
	/s/ Torbjörn Hallberg

	Name:
	Torbjörn Hallberg

	Title:
	General Counsel

[Signature Page to License and Development Agreement]

[***]

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[***]

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[***]

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[***]

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[***]

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[***]

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[***]

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[***]

82Exhibit

Exhibit 10.3

STOCK PURCHASE AGREEMENT
THIS STOCK PURCHASE AGREEMENT (this “Agreement”), dated as of June 11, 2020, is entered into by and between Selecta Biosciences, Inc., a Delaware corporation (the “Company”), and Swedish Orphan Biovitrum AB (publ), a Swedish public limited liability company (the “Purchaser”).

RECITALS
WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 1933, as amended (the “Securities Act”) contained in Section 4(a)(2) thereof and/or Regulation D promulgated thereunder, the Company desires to issue and sell to the Purchaser, and the Purchaser desires to purchase from the Company, 5,416,390 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”).
WHEREAS, in connection with the consummation of the purchase and sale of the Shares, the Company and the Purchaser shall execute and deliver the Registration Rights Agreement, in the form attached hereto as Appendix II (the “Registration Rights Agreement”).
NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and the Purchaser agree as follows:

SECTION 1.  DEFINITIONS
In addition to the terms defined elsewhere in this Agreement, the following terms have the meanings set forth in this Section 1:
“Affiliate” means, with respect to any Person, another Person which controls, is controlled by or is under common control with such Person. A Person shall be deemed to control another Person if such Person possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by contract or otherwise. For the purposes of this Agreement, in no event shall the Purchaser or any of its Affiliates be deemed Affiliates of the Company or any of its Affiliates, nor shall the Company or any of its Affiliates be deemed Affiliates of the Purchaser or any of its Affiliates.
“Business Day” means any day except Saturday, Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in New York City are authorized or required by law or other governmental action to close.
“Change of Control” means, with respect to a Person, any of the following events: (i) any other Person is or becomes the beneficial owner (as such term is defined in Rule 13d-3 under the Exchange Act, except that a Person shall be deemed to have beneficial ownership of all shares that any such Person has the right to acquire, whether such right which may be exercised immediately 

or only after the passage of time), directly or indirectly, of a majority of the total voting power represented by all shares of such Person’s outstanding capital stock; (ii) such Person consolidates with or merges into another corporation or entity, or any corporation or entity consolidates with or merges into such Person, other than (A) a merger or consolidation which would result in the voting securities of such Person outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof) a majority of the combined voting power of the voting securities of such Person or such surviving entity or any parent thereof outstanding immediately after such merger or consolidation, or (B) a merger or consolidation effected to implement a recapitalization of such Person (or similar transaction) in which no Person becomes the beneficial owner, directly or indirectly, of a majority of the total voting power of all shares of capital stock of such Person, or (iii) such Person conveys, transfers or leases all or substantially all of its assets, to any Person other than a wholly owned Affiliate of such Person.
“Closing” means the purchase and sale of the Shares pursuant to this Agreement.
“Closing Date” means the Trading Day when all of the Transaction Documents and the License Agreement have been executed and delivered by the applicable parties thereto, and all of the conditions set forth in Section 2, Section 3 and Section 6 hereof are satisfied or waived, as the case may be, or such other date as the parties may agree, provided that in no event shall the Closing Date be earlier than July 1, 2020.
“Closing Purchase Amount” means the aggregate amount to be paid for the Shares purchased hereunder as set forth on Exhibit A hereto in United States Dollars and in immediately available funds.
“Commission” means the U.S. Securities and Exchange Commission.
“Common Stock” has the meaning set forth in the recitals to this Agreement.
“Common Stock Equivalents” means any securities of the Company which would entitle the holder thereof to acquire at any time shares of Common Stock, including, without limitation, any debt, preferred shares, rights, options, warrants or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, shares of Common Stock.
“Company” has the meaning set forth in the recitals to this Agreement.
“Exchange Act” means the Securities Exchange Act of 1934, as amended.
“Intellectual Property” means all patents, patent applications, trademarks, trademark applications, service marks, trade names, copyrights, trade secrets, licenses, domain names, information and proprietary rights and processes.
“License Agreement” means the license agreement, dated as of June 11, 2020, by and between the Company and Purchaser.

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“Material Adverse Effect” means a material adverse effect on (i) the assets, liabilities, results of operations, financial condition or business of the Company and its subsidiaries taken as a whole, (ii) the legality or enforceability of any of the Transaction Documents or (iii) the ability of the Company to perform its obligations under the Transaction Documents; provided, however, that in no event shall any of the following occurring after the date hereof, alone or in combination, be deemed to constitute, or be taken into account in determining whether a Material Adverse Effect has occurred: (1) changes or conditions generally affecting the industries in which the Company operates, or the economy or the financial, debt, banking, capital, credit or securities markets, in the United States, including effects on such industries, economy or markets resulting from any regulatory and political conditions or developments in general, (2) the outbreak or escalation of war or acts of terrorism or any natural disasters, acts of God or comparable events, epidemic, pandemic or disease outbreak (including the COVID-19 virus), (3) changes in applicable law or GAAP, or the interpretation or enforcement thereof after the date of this Agreement, or (4) any change, in and of itself, in the market price or trading volume of the Company’s securities (it being understood that the facts or occurrences giving rise to or contributing to such change may be deemed to constitute, or be taken into account in determining whether there has been or would reasonably be expected to become, a Material Adverse Effect, to the extent permitted by this definition and not otherwise excepted by a clause of this proviso).
“Nasdaq Stock Market” means The Nasdaq Global Market or such other tier of Nasdaq on which the Common Stock is listed or quoted for trading on the date in question.
“Per Share Purchase Price” has the meaning set forth in Section 2.1.
“Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein, including any syndicate or group that would be deemed to be a Person under Section 13(d)(3) of the Exchange Act.
“Permitted Transferee” means an Affiliate of the Purchaser that is owned, directly or indirectly, by the Purchaser; it being understood that for purposes of this definition “owned” shall mean an Affiliate in which the Purchaser owns, directly or indirectly, at least fifty percent (50%) of the outstanding capital stock or ownership interests of such Affiliate.
“Registration Rights Agreement” has the meaning set forth in the recitals to this Agreement.
“SEC Documents” has the meaning set forth in Section 4.5.
“Securities Act” has the meaning set forth in the recitals to this Agreement.
“Shares” has the meaning set forth in the recitals to this Agreement.
“Short Sales” means, all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall not be deemed to include the location and/or reservation of borrowable shares of Common Stock).

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“Third Party” shall mean any Person (other than a governmental authority) other than the Purchaser, the Company or any Affiliate of the Purchaser or the Company.
“Trading Day” means a day on which the Common Stock is listed or quoted and traded on the Nasdaq Stock Market.
“Transaction Documents” means this Agreement and the Registration Rights Agreement, all exhibits and schedules thereto and hereto and any other documents or agreements executed in connection with the transactions contemplated hereunder.
“Transfer” means any (i) offer, pledge, sale, contract to sell, sale of any option or contract to purchase, purchase of any option or contract to sell, grant of any option, right or warrant for the sale of, or other disposition of or transfer of any shares of Common Stock or Common Stock Equivalents, including, without limitation, any “short sale” or similar arrangement, or (ii) swap, hedge, derivative instrument, or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of shares of Common Stock or Common Stock Equivalents, whether any such swap or transaction is to be settled by delivery of securities, in cash or otherwise.

SECTION 2.  PURCHASE AND SALE OF THE SHARES
2.1    Purchase and Sale. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company will issue and sell to the Purchaser, and the Purchaser will purchase, the number of Shares set forth on Exhibit A attached hereto, at a price per Share equal to $4.6156 (the “Per Share Purchase Price”). 
2.2    Compliance with Rules of Principal Market. The Company shall not issue any Shares pursuant to this Agreement if such issuance would reasonably be expected to result in (i) a violation of the Securities Act or (ii) a breach of the rules and regulations of the Nasdaq Stock Market.
2.3    Adjustments for Stock Dividends and Splits. In the event of any stock dividend, stock split, combination or other similar recapitalization affecting the Common Stock after the effectiveness of this Agreement and prior to the Closing, as the case may be, the number of shares of Common Stock to be sold to the Purchaser in the Closing and the Per Share Purchase Price shall be appropriately adjusted and Exhibit A attached hereto shall be updated accordingly.

SECTION 3.  CLOSING AND DELIVERY.
3.1    Closing.
(a)    Subject to the terms and conditions set forth herein, the Closing of the purchase and sale of the Shares shall take place at the offices of Latham & Watkins LLP, 650 Town Center Drive, 20th Floor, Costa Mesa, CA 92626, on the Closing Date or at such other locations or remotely by facsimile transmission or other electronic means as the parties may mutually agree.

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(b)    On the Closing Date, the Purchaser shall deliver or cause to be delivered to the Company the Closing Purchase Amount via wire transfer of immediately available funds pursuant to the wire instructions delivered to the Purchaser by the Company on or prior to the Closing Date.
3.2    Issuance and Delivery.
(a)    On the Closing Date, the Company shall issue and deliver, or cause to be delivered, to the Purchaser, subject to adjustment as provided in Section 2.3, evidence satisfactory to the Purchaser of book-entry Shares registered in the name of the Purchaser, in an amount equal to the number of Shares set forth on Exhibit A attached hereto.
(b)    The name in which the Shares are to be issued to the Purchaser is set forth in the Stockholder Notice and Questionnaire in the form attached hereto as Appendix I (the “Selling Stockholder Questionnaire”), which shall be provided to the Company no later than the date hereof.
3.3    Delivery of the Registration Rights Agreement and License Agreement.  On or before the date hereof, the Company and the Purchaser shall execute and deliver (i) the Registration Rights Agreement, pursuant to which the Company will agree to provide certain registration rights in respect of the resale by the Purchaser of the Shares under the Securities Act, and the rules and regulations promulgated thereunder, and (ii) the License Agreement.

SECTION 4.  REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
Except as set forth on the Schedule of Exceptions delivered to the Purchaser concurrently with the execution of this Agreement (the “Schedule of Exceptions”) (it being agreed that disclosure of any item in any part or subpart of the Schedule of Exceptions shall be deemed disclosure with respect to any other part or subpart to which the relevance of such item is reasonably apparent) or as otherwise described in the SEC Documents (as defined below), which qualify these representations and warranties in their entirety, the Company hereby represents and warrants, as of the date hereof and the Closing Date (except for the representations and warranties that speak as of a specific date, which shall be made as of such date), as follows:
4.1    Organization.   The Company and each of its subsidiaries are duly organized, validly existing as a corporation or other legal entity and in good standing (or the foreign equivalent thereof) under the laws of their respective jurisdictions of organization. The Company and each of its subsidiaries are duly licensed or qualified as a foreign corporation or other legal entity for transaction of business and in good standing under the laws of each other jurisdiction in which their respective ownership or lease of property or the conduct of their respective businesses requires such license or qualification, and have all corporate power and authority necessary to own or hold their respective properties and to conduct their respective businesses in which they are engaged as described in the SEC Documents (as defined below), except where the failure to be so qualified or in good standing or have such power or authority would not have or would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

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4.2    Subsidiaries.   Except as set forth in the SEC Documents, the Company owns, directly or indirectly, all of the equity interests in each of its subsidiaries free and clear of any lien, charge, security interest, encumbrance, right of first refusal or other restriction, and all the equity interests of the subsidiaries are validly issued and are fully paid, nonassessable and free of preemptive and similar rights. 
4.3    Corporate Power; Authorization.   The Company has all requisite corporate power, and has taken all requisite corporate action, to execute and deliver the Transaction Documents, sell and issue the Shares as contemplated by the Transaction Documents and carry out and perform all of its obligations under the Transaction Documents. Each Transaction Document constitutes the legal, valid and binding obligation of the Company and, assuming due execution and delivery by each of the other parties thereto, enforceable in accordance with its terms, except to the extent that (i) enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally and by general equitable principles and (ii) the indemnification provisions of the Registration Rights Agreement may be limited by federal or state securities laws, rules, regulations, or public policy considerations in respect thereof.
4.4    Issuance and Delivery of the Shares.   The Shares have been duly authorized for issuance and sale pursuant to this Agreement and, when issued and delivered by the Company against payment therefor pursuant to this Agreement, will be duly and validly issued, fully paid and nonassessable, free and clear of any pledge, lien, encumbrance, security interest or other claim, including any statutory or contractual preemptive rights, resale rights, rights of first refusal or other similar rights, except for restrictions on transfer set forth in the Transaction Documents or imposed by applicable securities laws, and, assuming the accuracy of the representations made by the Purchaser in Section 5, will be delivered in compliance with all applicable federal and state securities laws. Assuming the accuracy of the representations made by the Purchaser in Section 5, the offer and sale by the Company of the Shares is exempt from registration under the Securities Act. 
4.5    SEC Documents.   The Company has filed all reports, schedules, forms, statements and other documents required to be filed by the Company under Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof, for the one year preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such material) (the “SEC Documents”). At the time of filing thereof, the SEC Documents complied as to form in all material respects with the requirements of the Securities Act or the Exchange Act, as applicable, and, as of their respective dates, did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.
4.6    Financial Statements.   The financial statements of the Company, together with the related notes and any supporting schedules thereto, included in the SEC Documents (the “Financial Statements”) present fairly, in all material respects, the consolidated financial condition, results of operations and cash flows of the Company and each of its subsidiaries as of and at the dates indicated and the results of their operations and cash flows for the periods specified as of the dates and for the periods indicated.  The Financial Statements and any supporting schedules have been prepared in conformity with generally accepted accounting principles as applied in the United States (“GAAP”) applied on a consistent basis throughout the periods involved, except as may be expressly stated in the related notes thereto. Ernst & Young LLP, who have audited certain financial statements of the Company included in or incorporated by reference into the SEC Documents, is an independent registered public accounting firm with respect to the Company within the meaning of Article 2-01 of Regulation S-X and the Public Company Accounting Oversight Board (United States). 

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4.7    Capitalization.   The authorized capital stock of the Company consists of 200,000,000 shares of Common Stock and 10,000,000 shares of preferred stock, par value $0.0001 (the “Preferred Stock”).  There are no other shares of any other class or series of capital stock of the Company issued or outstanding.  The Company has not issued any capital stock since the date of its most recently filed SEC Document other than to reflect stock option and warrant exercises and vesting of restricted stock units that do not, individually or in the aggregate, have a material effect on the issued and outstanding capital stock, options and other securities.  As of March 31, 2020, there were (i) 87,019,172 shares of the Company’s Common Stock issued and outstanding and no shares of the Preferred Stock issued and outstanding; (ii) options to purchase 7,745,936 shares of the Company’s Common Stock outstanding; (iii) 170,313 unvested restricted stock units and (iv) warrants to purchase 31,426,248 shares of the Company’s Common Stock outstanding.  Except as stated above, there are no existing options, warrants, calls, subscriptions or other rights, agreements, arrangements or commitments relating to the issued or unissued capital stock of the Company, obligating the Company to issue, transfer, sell, redeem, purchase, repurchase or otherwise acquire or cause to be issued, transferred, sold, redeemed, purchased, repurchased or otherwise acquired any capital stock of the Company or securities or rights convertible into or exchangeable for such shares or equity interests or obligations of the Company to grant, extend or enter into any such option, warrant, call, subscription or other right, agreement, arrangement or commitment.  Except as provided in the Registration Right Agreement, the issuance of Shares pursuant to any provision of this Agreement will not give rise to any preemptive rights or rights of first refusal on behalf of any Person or result in the triggering of any anti-dilution rights, and, other than as set forth in the SEC Documents, there are no agreements or arrangements under which the Company or any of its subsidiaries is obligated to register the sale of any of their securities under the Securities Act, in each case except as have been duly and validly waived. 
4.8    Litigation.   There are no actions, suits or proceedings by or before any governmental authority pending, nor, to the Company’s knowledge, any audits or investigations by or before any governmental authority, to which the Company or a subsidiary is a party or to which any property of the Company or any of its subsidiaries is the subject that, individually or in the aggregate, if determined adversely to the Company or any of its subsidiaries, would have a Material Adverse Effect and, to the Company’s knowledge, no such actions, suits, proceedings, audits or investigations are threatened or contemplated by any governmental authority or threatened by others. There are no current or pending audits, investigations, actions, suits or proceedings by or before any governmental authority that are required under the Securities Act to be described in the SEC Documents that are not so described.
4.9    Consents.   No consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state, or local governmental authority on the part of the Company is required in connection with the consummation of the transactions contemplated by the Transaction Documents except for (a) the filing of a Form D with the Commission under the Securities Act, (b) the approval by the Nasdaq Stock Market of the listing of the additional shares, (c) the filing of one or more registration statements and all amendments thereto with the Commission as contemplated by the Registration Rights Agreement or (d) where failure to obtain such consents, approval or authorizations, or to make such filings, would not impair the ability of the Company to issue and sell the Shares or to consummate the transactions contemplated by this Agreement.
4.10    No Violation or Default.   Neither the execution, delivery nor performance of the Transaction Documents by the Company nor the consummation of any of the transactions contemplated thereby (including, without limitation, the issuance and sale by the Company of the Shares) conflict with, result in a breach or violation of, or imposition of, or constitute a default or a Debt Repayment Triggering Event (as defined below) under, or result in the imposition of any lien, charge or encumbrance 

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upon any property or assets of the Company or each of its subsidiaries pursuant to, (i) the charter, by-laws or similar organizational documents of the Company or each of its subsidiaries, (ii) any statute, rule, regulation or order of any governmental agency or body or any court, domestic or foreign, having jurisdiction over the Company or any of its subsidiaries or any of their properties (including, without limitation, the U.S. Food and Drug Administration (“FDA”)), or (iii) any agreement or instrument to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound or to which any of the properties of the Company or any of its subsidiaries is subject, except in the case of each of clauses (ii) and (iii), where such breaches, violations, defaults, liens, charges or encumbrances would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. A “Debt Repayment Triggering Event” means any event or condition that gives, or with the giving of notice or lapse of time would give, the holder of any note, debenture, or other evidence of indebtedness (or any Person acting on such holder’s behalf) the right to require the repurchase, redemption or repayment of all or a portion of such indebtedness by the Company or any of its subsidiaries.
4.11    No Material Adverse Change.   Since March 31, 2020, except as specifically set forth in a subsequent SEC Documents, there has not been:
(a)    any material change in the authorized capital, assets, liabilities, financial condition, business or operations of the Company and its subsidiaries taken as a whole from that reflected in the financial statements included in the Company’s most recently filed SEC Document;
(b)    any declaration or payment by the Company of any dividend, or any authorization or payment by the Company of any distribution, on any of the capital stock of the Company, or any redemption or repurchase by the Company of any securities of the Company; 
(c)    any change or amendment to the Company’s certificate of incorporation or by-laws, or material change to any material contract or arrangement by which the Company is bound or to which any of its assets or properties is subject; 
(d)    any action taken by the Company or a subsidiary of the Company to seek protection pursuant to any law or statute relating to bankruptcy, insolvency, reorganization, receivership, liquidation or winding up, nor does the Company have any knowledge that any of the creditors of the Company or a subsidiary of the Company intend to initiate involuntary bankruptcy proceedings, nor has the Company or any subsidiary of the Company received any notice from any such creditor threatening any such action; 
(e)    any material transaction entered into by the Company other than in the ordinary course of business; 
(f)    the loss of the services of any executive officer (as defined in Rule 405 under the Securities Act) of the Company; 
(g)    any material change in the Company’s accounting policies or in the Company’s internal controls over financial reporting; or
(h)    any other event or condition of any character that has had or would reasonably be expected to have a Material Adverse Effect.
4.12    Intellectual Property.   The Company and its subsidiaries own, possess, license or have other rights to use, the patents and patent applications, copyrights, trademarks, service marks, trade names, service names and trade secrets as necessary or material for use in connection with its businesses 

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as described in the SEC Documents (collectively, the “Intellectual Property Rights”), and to the Company’s knowledge, there are no material liens, security interests or encumbrances that have been filed against any of these Intellectual Property Rights. No actions, suits, proceedings or claims are pending, or to the Company’s knowledge, asserted or threatened against the Company or its subsidiaries alleging infringement of a patent or other intellectual property right of others. To the Company’s knowledge, there is no existing infringement by another Person of any of the Intellectual Property Rights that would materially affect the use thereof by the Company. To the Company’s knowledge, the Company is not liable for infringement with respect to any of the Company’s product candidates. To the Company’s knowledge, the development, manufacture, sale, and any currently proposed use of any of the products, proposed products or processes of the Company referred to in the SEC Documents, in the current or proposed conduct of the business of the Company, do not currently, and will not upon commercialization, to the Company’s knowledge, infringe any right or valid patent claim of any third party. To the Company’s knowledge, there are no ownership rights of third parties to any Intellectual Property Rights in any field of use that is exclusively licensed to the Company, other than any licensor to the Company of such Intellectual Property Rights. To the Company’s knowledge, no action, suit, claim or other proceeding, except for routine patent and trademark prosecution proceedings in patent offices throughout the world, is pending or threatened challenging the validity, enforceability, scope, registration, ownership or use of any of the Intellectual Property Rights. To the Company’s knowledge, no action, suit, claim or other proceeding is pending or threatened, challenging the Company’s rights in or to any Intellectual Property Rights.  The Company and its subsidiaries have security procedures to protect the secrecy, confidentiality and value of their Intellectual Property Rights. To the Company’s knowledge, no employee is in or has been in violation in any material respect of any term of any employment contract, invention assignment agreement, non-competition agreement, or nondisclosure agreement with a former employer, executed prior to such employee’s employment where the basis of such violation relates to such employee’s employment and such violation occurred while employed and while the contract was valid and in effect. All material licenses or other material agreements under which the Company is granted rights to Intellectual Property are, to the Company’s knowledge, in full force and effect and, to the Company’s knowledge, there is no material default by any other party thereto. To the Company’s knowledge, the licensors under material licenses and other material agreements had all requisite power and authority to grant the rights to the Intellectual Property purported to be granted thereby. To the Company’s knowledge, the consummation of the transactions contemplated hereby and by the other Transaction Documents will not result in the alteration, loss, impairment of or restriction on the Company’s or any of its subsidiaries’ ownership or right to use any Intellectual Property that is material to the conduct of the Company’s business as now conducted.
4.13    Clinical Studies.   The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, good clinical practice, informed consent and all applicable laws, regulations and requirements. The Company has filed with the FDA or other appropriate governmental entity all material required notices, and annual or other reports, including notices of adverse experiences and reports of serious and unexpected adverse experiences, related to the use of its product candidates in clinical trials. The descriptions of the studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, contained in the SEC Documents are accurate and complete in all material respects; the Company is not aware of any other studies, tests or preclinical and clinical trials, the results of which call into question the results described in the SEC Documents; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board requiring the termination, suspension, material 

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modification or clinical hold of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA and any other governmental entity. The Company has not been informed by the FDA or any other governmental entity that the FDA or any other governmental entity will prohibit the testing, distribution, marketing, sale, license or use of any product proposed to be developed, produced, tested, distributed or marketed by the Company. Neither the Company nor, to the Company’s knowledge, any of its officers or employees has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. Neither the Company nor, to the Company’s knowledge, any officer or employee of the Company has been convicted of any crime or engaged in any conduct that has resulted in or would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation.
4.14    Properties and Assets.   The Company and its subsidiaries have good and marketable title in fee simple to all items of real property owned by them, good and valid title to all personal property owned by them that are material to the businesses of the Company or such subsidiary, in each case free and clear of all liens, encumbrances and claims, except those matters that (i) do not materially interfere with the use made and proposed to be made of such property by the Company and any of its subsidiaries or (ii) would not, individually or in the aggregate, have a Material Adverse Effect. Any real or personal property leased by the Company and any of its subsidiaries is held by them under valid, existing and enforceable leases, except those that (A) do not materially interfere with the use made or proposed to be made of such property by the Company or any of its subsidiaries or (B) would not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect. 
4.15    Possession of Licenses and Permits.   Except in such cases that would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiaries (i) possess, and are in compliance with the terms of, all adequate certificates, authorizations, franchises, licenses and permits (“Licenses”) from, and have made all declarations, filings, listings, registrations, reports and submissions with, the appropriate federal, state, local or foreign governmental or regulatory authorities including, without limitation, from the FDA and equivalent foreign regulatory authorities, in each case that are necessary or material to the conduct of the business now conducted, (ii) have not received any notice of proceedings relating to the revocation or modification of any Licenses, and (iii) are not in material violation of, or in default under, any such License.
4.16    Taxes.   The Company and each of its subsidiaries have filed all federal, state, local and foreign tax returns which have been required to be filed and paid all taxes shown thereon through the date hereof, to the extent that such taxes have become due and are not being contested in good faith, except where the failure to so file or pay would not have a Material Adverse Effect, and no tax deficiency has been determined adversely to the Company or any of its subsidiaries which has had, or would have, individually or in the aggregate, a Material Adverse Effect. The Company has no knowledge of any federal, state or other governmental tax deficiency, penalty or assessment which has been asserted or threatened against it which would have a Material Adverse Effect.
4.17    Investment Company.   Neither the Company nor any of its subsidiaries is, and, after giving effect to the offering and sale of the Shares, will not be, required to register as an “investment company” or an entity “controlled” by an “investment company,” as such terms are defined in the Investment Company Act of 1940 (the “Investment Company Act”).

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4.18    Insurance.   The Company and its subsidiaries maintain insurance covering their respective properties, operations, personnel and businesses as the Company reasonably deems adequate; the Company reasonably believes such insurance insures against such losses and risks in accordance with customary industry practice to protect the Company and the subsidiaries and their respective businesses and which is commercially reasonable for the current conduct of their respective businesses; to the Company’s knowledge, all such insurance is fully in force on the date hereof. 
4.19    Compliance with Nasdaq Requirements.   The Company is in compliance with applicable rules of the Nasdaq Stock Market, including the continued listing requirements thereunder. There are no proceedings pending or, to the Company’s knowledge, threatened against the Company relating to the continued listing of the Common Stock on the Nasdaq Stock Market and the Company has not received any notice of, nor to the Company’s knowledge is there any reasonable basis for, the delisting of the Common Stock from the Nasdaq Stock Market.
4.20    Internal Control over Financial Reporting; Sarbanes-Oxley Matters.   The Company has established and maintains disclosure controls and procedures (as defined in Rules 13a-15(c) and 15d-15(e) of the Exchange Act) for the Company and designed such disclosure controls and procedures to ensure that material information relating to the Company and required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is made known to the certifying officers by others within the Company. The Company maintains a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset and liability accountability, and (iii) access to assets or incurrence of liabilities is permitted only in accordance with management’s general or specific authorization. The Company’s certifying officers have evaluated the effectiveness of the Company’s controls and procedures as of the end of the period covered by the most recently filed periodic report under the Exchange Act (such date, the “Evaluation Date”). The Company presented in its most recently filed periodic report under the Exchange Act the conclusions of the certifying officers about the effectiveness of the disclosure controls and procedures based on their evaluations as of the Evaluation Date. Since the end of the Company’s most recent audited fiscal year, to the Company’s knowledge, there have been no significant deficiencies or material weakness detected in the Company’s internal control over financial reporting (whether or not remediated) and no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company is not aware of any change in its internal controls over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. The Company maintains a standard system of accounting established and administered in accordance with GAAP and the applicable requirements of the Exchange Act.
4.21    Labor Disputes.   No labor disturbance by or dispute with employees of the Company or any of its subsidiaries exists or, to the knowledge of the Company, is threatened which would result in a Material Adverse Effect.
4.22    Brokers and Finders.   No Person will have, as a result of the transactions contemplated by the Transaction Documents, any valid right, interest or claim against or upon the Company or the Purchaser for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company, other than pursuant to the Company’s engagement of Cantor Fitzgerald as the Company’s financial advisor, the fees of which are payable by the Company. The Purchaser shall not have any obligation with respect to any fees, or with respect to 

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any claims made by or on behalf of other Persons for fees, in each case of the type contemplated by this Section 4.22 that may be due in connection with the transactions contemplated by this Agreement or the Transaction Documents.
4.23    Manipulation of Price.   The Company has not, and, to the Company’s knowledge, no Person acting on its behalf has taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale of any of the Shares.  
4.24    No Integrated Offering.   Neither the Company nor any of its subsidiaries, officers, directors, any person acting on its or their behalf, nor to the Company’s knowledge, any of its affiliates, has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any Company security, under circumstances that would require registration of any of the Shares under the Securities Act or cause this offering of the Shares to be integrated with prior offerings by the Company for purposes of the Securities Act.
4.25    ERISA.   To the knowledge of the Company, each material employee benefit plan, within the meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), that is maintained, administered or contributed to by the Company or any of its affiliates for employees or former employees of the Company and any of its subsidiaries has been maintained in material compliance with its terms and the requirements of any applicable statutes, orders, rules and regulations, including ERISA and the Internal Revenue Code of 1986, as amended (the “Code”); no prohibited transaction, within the meaning of Section 406 of ERISA or Section 4975 of the Code, has occurred which would result in a material liability to the Company with respect to any such plan excluding transactions effected pursuant to a statutory or administrative exemption; and for each such plan that is subject to the funding rules of Section 412 of the Code or Section 302 of ERISA, no “accumulated funding deficiency” as defined in Section 412 of the Code has been incurred, whether or not waived, and the fair market value of the assets of each such plan (excluding for these purposes accrued but unpaid contributions) exceeds the present value of all benefits accrued under such plan determined using reasonable actuarial assumptions; neither the Company nor any of its affiliates sponsors, maintains, contributes to, participates in or has any obligations to, or any liability under, any multiemployer plan (as defined in Section 4001(a)(3) of ERISA). 
4.26    Money Laundering Laws.   The operations of the Company and its subsidiaries are and have been conducted at all times in compliance with applicable financial record keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, the money laundering laws of all jurisdictions to which the Company or its subsidiaries are subject, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental authority (collectively, the “Money Laundering Laws”); and no action, suit or proceeding by or before any governmental authority involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.
4.27    No Improper Practices.   (i) Neither the Company nor its subsidiaries, nor, to the Company’s knowledge, any current or former director, officer, employee, agent, affiliate or other person acting on behalf of the Company or any subsidiary has used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity, or made or taken an act in furtherance of an offer, promise or authorization of any direct or indirect unlawful payment or benefit to any foreign or domestic government or regulatory official or employee, including of any government-owned or controlled entity or of a public international organization, or any person acting in an official capacity for or on behalf of any of the foregoing, or any political party or party official or 

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candidate for political office; (ii) no relationship, direct or indirect, exists between or among the Company or any subsidiary or any affiliate of any of them, on the one hand, and the directors, officers and stockholders of the Company or any subsidiary, on the other hand, that is required to be described in the SEC Documents that is not so described, except as would not cause a Material Adverse Effect; (iii) except as described in the SEC Documents, there are no material outstanding loans or advances or material guarantees of indebtedness by the Company or any subsidiary to or for the benefit of any of their respective officers or directors or any of the members of the families of any of them; and (iv) the Company has not offered, or caused any placement agent to offer, securities to any person with the intent to influence unlawfully (A) a customer or supplier of the Company or any subsidiary to alter the customer’s or supplier’s level or type of business with the Company or any subsidiary or (B) a trade journalist or publication to write or publish favorable information about the Company or any subsidiary or any of their respective products or services, and, (v) neither the Company nor any subsidiary nor any director, officer or employee of the Company or any subsidiary nor, to the Company’s knowledge, any agent, affiliate or other person acting on behalf of the Company or any subsidiary has (A) violated or is in violation of any applicable provision of the U.S. Foreign Corrupt Practices Act of 1977, or any other applicable anti-bribery or anti-corruption law (collectively, “Anti-Corruption Laws”), (B) promised, offered, provided, attempted to provide or authorized the provision of anything of value, directly or indirectly, to any person for the purpose of obtaining or retaining business, influencing any act or decision of the recipient or securing any improper advantage, or (C) made any payment of funds of the Company or any subsidiary or received or retained any funds in violation of any Anti-Corruption Laws.
4.28    Sanctions.
(a)    The Company represents that neither the Company nor any of its subsidiaries (collectively, the “Entity”) or, to its knowledge, any current or former director, officer, employee, agent, affiliate or representative of the Entity, is (or is owned or controlled by) a person that is: (i) the subject of any sanctions administered or enforced by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”), the United Nations Security Council, the European Union, Her Majesty’s Treasury, or other relevant sanctions authorities, including designation on OFAC’s Specially Designated Nationals and Blocked Persons List or OFAC’s Foreign Sanctions Evaders List (as amended, collectively, “Sanctions”), nor (ii) located, organized or resident in a country or territory that is the subject of Sanctions that broadly prohibit dealings with that country or territory (including Cuba, Iran, North Korea, Syria and the Crimea Region of the Ukraine) (the “Sanctioned Countries”), nor directly or indirectly owned or controlled by a person subject to Sanctions or located, organized or resident in any Sanctioned Countries.
(b)    The Entity represents and covenants that it will not, directly or indirectly, knowingly use the proceeds of the sale of the Shares hereunder (the “Offering”), or lend, contribute or otherwise make available such Offering proceeds to any subsidiary, joint venture partner or other Person: (i) to fund or facilitate any activities or business of or with any Person or in any country or territory that, at the time of such funding or facilitation, is the subject of Sanctions or is a Sanctioned Country; or (ii) in any other manner that will result in a violation of Sanctions by any Person (including any Person participating in the Offering, whether as underwriter, advisor, investor or otherwise).
(c)    The Entity represents and covenants that, for the past 5 years, it has not engaged in, is not now engaging in, and will not engage in, any dealings or transactions with any Person, or in any country or territory, that at the time of the dealing or transaction is or was the subject of Sanctions or is or was a Sanctioned Country, in each case in a manner that would violate applicable law; the Entity shall maintain policies and procedures designed to promote and achieve compliance with the Sanctions and Anti-Corruption Laws applicable to it and each of its affiliates and subsidiaries.

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4.29    Environmental Laws.   Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, neither the Company nor any of its subsidiaries is in violation of any statute, rule, regulation, decision or order of any governmental agency or body or any court, domestic or foreign, relating to the use, disposal or release of hazardous or toxic substances or relating to the protection or restoration of the environment or human exposure to hazardous or toxic substances (collectively, “Environmental Laws”), has released any hazardous substances regulated by Environmental Law on to any real property that it owns or operates, or has received any written notice or claim that it is liable for any off-site disposal or contamination pursuant to any Environmental Laws; and to the Company’s knowledge, there is no pending or threatened investigation that would reasonably be expected to lead to such a claim.
4.30    Compliance with Laws.   The Company has operated and currently is in compliance in all material respects with all applicable Health Care Laws (defined herein), including, without limitation, the rules and regulations of the FDA, the U.S. Department of Health and Human Services Office of Inspector General, the Centers for Medicare & Medicaid Services, the Office for Civil Rights, the Department of Justice or any other governmental agency or body having jurisdiction over the Company or any of its properties, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” shall mean the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Act (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.) (“HIPAA”), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the patient privacy, data security and breach notification provisions under HIPAA, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other similar local, state or federal law and regulations. The Company has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence, communication or notice from the FDA or any other governmental or regulatory authority alleging or asserting noncompliance with any Health Care Laws applicable to the Company. The Company is not a party to nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Neither the Company nor any of its employees, officers, directors or, to the Company’s knowledge, consultants has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or, to the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
4.31    Regulatory.   The Company has conducted an assessment and determined that none of the Company, any subsidiary, or any of its affiliates (a) produce, design, test, manufacture, fabricate, or develop “critical technologies” as that term is defined in 31 C.F.R. § 800.215; (b) perform the functions as set forth in column 2 of Appendix A to 31 C.F.R. part 800 with respect to covered investment critical infrastructure; or (c) maintain or collect, directly or indirectly, “sensitive personal data” as that term is defined in 31 C.F.R. § 800.241.

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SECTION 5.   REPRESENTATIONS AND WARRANTIES OF PURCHASER.
5.1    The Purchaser hereby represents and warrants, as of the date hereof and the Closing Date, to the Company that:
(a)    Purchaser is a duly organized, validly existing corporation, limited partnership or limited liability company and in good standing under the laws of the jurisdiction of its organization with the requisite corporate, partnership or limited liability company power and authority to enter into and consummate the transactions contemplated by the Transaction Documents and to carry out its obligations hereunder and thereunder, and to invest in the Shares pursuant to this Agreement.
(b)    Purchaser acknowledges that it can bear the economic risk and complete loss of its investment in the Shares and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment contemplated hereby.
(c)    Purchaser has had an opportunity to receive, review and understand all information related to the Company requested by it and to ask questions of and receive answers from the Company regarding the Company and its subsidiaries, its business and the terms and conditions of the offering of the Shares, and has conducted and completed its own independent due diligence. Purchaser acknowledges that the Company has made available the SEC Documents. Based on the information the Purchaser has deemed appropriate, and without reliance upon any placement agent, it has independently made its own analysis and decision to enter into the Transaction Documents. Purchaser is relying exclusively on its own sources of information, investment analysis and due diligence (including professional advice it deems appropriate) with respect to the execution, delivery and performance of the Transaction Documents, the Shares and the business, condition (financial and otherwise), management, operations, properties and prospects of the Company, including but not limited to all business, legal, regulatory, accounting, credit and tax matters. Purchaser is not relying and has not relied on any representations or warranties whatsoever regarding the subject matter of this Agreement, express or implied, except for the representations and warranties set forth in Section 4. Such representations and warranties by the Company constitute the sole and exclusive representations and warranties of the Company in connection with the transactions contemplated by this Agreement and Purchaser understands, acknowledges and agrees that all other representations and warranties of any kind or nature whether express, implied or statutory are specifically disclaimed by the Company.
(d)    The Shares to be received by the Purchaser hereunder will be acquired for the Purchaser’s own account, not as nominee or agent, and not with a view to the resale or distribution of any part thereof in violation of the Securities Act, and the Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same in violation of the Securities Act without prejudice, however, to the Purchaser’s right at all times to sell or otherwise dispose of all or any part of such Shares in compliance with applicable federal and state securities laws. Purchaser understands that the Shares are characterized as “restricted securities” under the U.S. federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration under the Securities Act only in certain limited circumstances. 

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Purchaser represents that it is familiar with Rule 144 under the Securities Act (“Rule 144”), as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act. Purchaser will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) any of the securities purchased hereunder except in compliance with the Securities Act, applicable blue sky laws, and the rules and regulations promulgated thereunder.
(e)    Purchaser has determined based on its own independent review and such professional advice as it deems appropriate that its purchase of the Shares and participation in the transactions contemplated by the Transaction Documents (i) are consistent with its financial needs, objectives and condition, (ii) comply and are consistent with all investment policies, guidelines and other restrictions applicable to the Purchaser, (iii) do not and will not violate or constitute a default under the Purchaser’s charter, by-laws or other constituent document or under any law, rule, regulation, agreement or other obligation by which the Purchaser is bound and (iv) are a fit, proper and suitable investment for the Purchaser, notwithstanding the substantial risks inherent in investing in or holding the Shares.
(f)    The execution, delivery and performance by the Purchaser of the Transaction Documents have been duly authorized and each has been duly executed and when delivered will constitute the valid and legally binding obligation of the Purchaser, enforceable against the Purchaser in accordance with their respective terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability, relating to or affecting creditors’ rights generally.
(g)    Purchaser is an “accredited investor” within the meaning of Rule 501(a) under the Securities Act. Purchaser is not a broker or dealer registered pursuant to Section 15 of the Exchange Act (a “registered broker-dealer”) or an entity engaged in a business that would require it to be so registered and is not affiliated with a registered broker dealer or an entity engaged in a business that would require it to be so registered.  Purchaser is not party to any agreement for distribution of any of the Shares.
(h)    Purchaser shall have completed or caused to be completed and delivered to the Company at no later than the date hereof, the Selling Stockholder Questionnaire for use in preparation of the registration statement(s) meeting the requirements set forth in the Registration Rights Agreement and covering the resale by the Purchaser of the Registrable Securities (as defined in the Registration Rights Agreement) (each, a “Registration Statement”), and the answers to the Selling Stockholder Questionnaire are true and correct in all material respects as of the date of this Agreement and will be true and correct as of the Closing and the effective date of each Registration Statement; provided, that the Purchaser shall be entitled to update such information by providing notice thereof to the Company before the effective date of each such Registration Statement.
(i)    Purchaser understands that no U.S. federal or state agency, or similar agency of any other country, has reviewed, approved, passed upon, or made any recommendation or endorsement of the Company or the purchase of the Shares. 

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(j)    Purchaser has not taken any of the actions set forth in, and is not subject to, the disqualification provisions of Rule 506(d)(1) of the Securities Act (each a “Disqualification Event”).  Purchaser hereby agrees that it shall notify the Company promptly in writing in the event a Disqualification Event becomes applicable to the Purchaser or any of its Rule 506(d) Related Parties, except, if applicable, for a Disqualification Event as to which Rule 506(d)(2)(ii) or (iii) or (d)(3) is applicable. For purposes of this Subsection 5.1(j), “Rule 506(d) Related Party” shall mean a person or entity that is a beneficial owner of the Purchaser’s securities for purposes of Rule 506(d) of the Securities Act.
(k)    Purchaser did not learn of the investment in the Shares as a result of any general solicitation or general advertising.
(l)    Purchaser’s offices in which its investment decision with respect to the Shares was made are located at the address immediately below the Purchaser’s name on its signature page hereto.
5.2    Purchaser understands that nothing in this Agreement or any other materials presented to the Purchaser in connection with the purchase and sale of the Shares constitutes legal, tax or investment advice.  Purchaser has consulted such legal, tax and investment advisors as it, in its sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.
5.3    Legends.
(a)    Purchaser understands that, until such time as the Shares have been sold pursuant to a Registration Statement or the Shares may be sold pursuant to Rule 144 without any restriction as to the number of securities as of a particular date that can then be immediately sold, the book entry notations evidencing the Shares may bear one or more legends in substantially the following form and substance: 
“THESE SECURITIES, INCLUDING ANY SECURITIES INTO WHICH THESE SECURITIES IS EXERCISABLE, HAVE NOT BEEN REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY OTHER APPLICABLE SECURITIES LAWS AND HAVE BEEN ISSUED IN RELIANCE UPON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND SUCH OTHER SECURITIES LAWS. NEITHER THIS SECURITY NOR ANY INTEREST OR PARTICIPATION HEREIN MAY BE REOFFERED, SOLD, ASSIGNED, TRANSFERRED, PLEDGED, ENCUMBERED, HYPOTHECATED OR OTHERWISE DISPOSED OF, EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO A TRANSACTION WHICH IS EXEMPT FROM, OR NOT SUBJECT TO, SUCH REGISTRATION REQUIREMENTS, IN EACH CASE IN ACCORDANCE WITH ALL APPLICABLE SECURITIES LAWS, AND IN THE CASE OF A TRANSACTION EXEMPT FROM, OR NOT SUBJECT TO, SUCH REGISTRATION, UNLESS THE COMPANY HAS RECEIVED AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO IT THAT SUCH 

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TRANSACTION DOES NOT REQUIRE REGISTRATION UNDER THE SECURITIES ACT AND SUCH OTHER APPLICABLE LAWS.”
In addition, book entry notations representing the Shares may contain such other restrictive legends as may be reasonably required under applicable state blue sky laws.
(b)    The Company agrees that at such time as any legend is no longer required under this Section 5.3, it will, no later than three (3) Business Days following the delivery by the Purchaser to the Company or the Company’s transfer agent of a request to remove such legend, together with such representations and covenants of the Purchaser or the Purchaser’s executing broker as the Company may reasonably require in connection therewith, deliver or cause to be delivered to the Purchaser a book entry position representing such shares that is free from any such legend.  The Company shall not make any notation on its records or give instructions to any transfer agent of the Company that enlarge the restrictions on transfer set forth in this Section 5.3.  Any certificates for Shares subject to legend removal shall be transmitted by the transfer agent of the Company to the Purchaser by crediting the account of the Purchaser’s prime broker with the Depository Trust Company (“DTC”).  All costs and expenses related to the removal of the legends and the reissuance of any Shares shall be borne by the Company.
(c)    The restrictive legend set forth in this Section 5.3 above shall be removed and the Company shall issue a certificate or book entry position without such restrictive legend or any other restrictive legend to the holder of the applicable shares upon which it is stamped or issue to such holder by electronic delivery with the applicable balance account at DTC or in physical certificated shares, if appropriate, if (i) such Shares have been sold or transferred pursuant to an effective Registration Statement; (ii) such Shares are sold or transferred pursuant to Rule 144 (if the transferor is not an affiliate of the Company); or (iii) such Shares are eligible for sale without the requirement for the Company to be in compliance with the current public information required under Rule 144 as to such securities and without volume or manner-of-sale restrictions.  Upon Rule 144 becoming available for the resale of the Shares, without the requirement for the Company to be in compliance with the current public information required under Rule 144 as to the Shares and without volume or manner-of-sale restrictions, the Company shall, at the request of the Purchaser, issue to the Company’s transfer agent the instructions with respect to legend removal consistent with this Section 5.3.  Any fees (with respect to the transfer agent, the Company’s counsel or otherwise) associated with the issuance of such opinion or the removal of such legend shall be borne by the Company.

SECTION 6.  CONDITIONS TO CLOSING.
6.1    The obligation of the Purchaser to purchase the Shares at the Closing is subject to the fulfillment to the Purchaser’s satisfaction, on or prior to the Closing Date, of each of the following conditions, any of which may be waived by the Purchaser:
(a)    The representations and warranties made by the Company in Section 4 hereof and in Section 12 of the License Agreement shall be true and correct in all material respects as of the date when made and as of the Closing Date, as though made on and as of such date, except to the extent that any such representation or warranty expressly speaks as of an earlier date, in which 

18

case such representation or warranty shall be true and correct in all material respects as of such earlier date. The Company shall have performed in all material respects all obligations and covenants in the Transaction Documents and the License Agreement required to be performed by it on or prior to the Closing Date.
(b)    With the exception of declarations of effectiveness by the Commission with respect to the registration statements contemplated in the Registration Rights Agreement, the Company shall have obtained any and all consents, permits, approvals, registrations and waivers necessary for consummation of the purchase and sale of the Shares and the consummation of the other transactions contemplated by the Transaction Documents, all of which shall be in full force and effect. 
(c)    The Company shall have filed with the Nasdaq Stock Market a Notification Form: Listing of Additional Shares for the listing of the Shares and cause such approval to be obtained.
(d)    No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any governmental authority, shall have been issued, and no action or proceeding shall have been instituted by any governmental authority, enjoining or preventing the consummation of the transactions contemplated at the Closing.
(e)    Purchaser shall have received a certificate signed by the Chief Executive Officer or the Principal Financial Officer of the Company, dated as of the Closing Date, certifying to the fulfillment of the conditions specified in subsections (a), (b), (c), (d), (h), and (i) of this Section 6.1.
(f)    Purchaser shall have received a certificate signed by the Company’s Secretary, dated as of the Closing Date, certifying the resolutions adopted by the board of directors of the Company (the “Board”) approving the transactions contemplated by the Transaction Documents and the License Agreement and the issuance of the Shares, certifying the current versions of the certificate of incorporation and by-laws of the Company and certifying as to the signatures and authority of persons signing the Transaction Documents, the License Agreement and related documents on behalf of the Company.
(g)    Purchaser shall have received an opinion of Gibson, Dunn & Crutcher LLP, counsel to the Company, dated as of the Closing Date, covering the opinions listed on Exhibit B. 
(h)    No stop order or suspension of trading shall have been imposed by the Nasdaq Stock Market, the Commission or any other governmental regulatory body with respect to public trading in the Common Stock. 
(i)    There shall not have occurred any material adverse change in the Company’s consolidated business or financial condition since the date of the Company’s most recently filed SEC Document.

19

(j)    The Company shall have executed and delivered to the Purchaser the Registration Rights Agreement.
(k)    The Company shall have executed the License Agreement and the Effective Date (as defined in the License Agreement) shall have occurred.
6.2    The obligation of the Company to sell and issue the Shares and to deliver the Shares to the Purchaser at the Closing is subject to fulfillment to the satisfaction of the Company on or prior to the Closing Date of the following conditions, any of which may be waived by the Company:
(a)    The representations and warranties made by the Purchaser in Section 5 hereof and in Section 12 of the License Agreement shall be true and correct in all material respects as of the date when made and as of the Closing Date, except to the extent that any such representation or warranty expressly speaks as of an earlier date, in which case such representation or warranty shall be true and correct in all material respects as of such earlier date. Purchaser shall have performed in all material respects all obligations and covenants herein required to be performed by it on or prior to the Closing Date.
(b)    Purchaser shall have executed and delivered to the Company the Registration Rights Agreement and the License Agreement.
(c)    The Effective Date (as defined in the License Agreement) shall have occurred. 
(d)    The Company shall have received payment, by wire transfer of immediately available funds, in the full amount of the purchase price for the number of Shares being purchased at the Closing, as determined in accordance with Section 2 hereof.
(e)    No judgment, writ, order, injunction, award or decree of or by any court, or judge, justice or magistrate, including any bankruptcy court or judge, or any order of or by any governmental authority, shall have been issued, and no action or proceeding shall have been instituted by any governmental authority, enjoining or preventing the consummation of the transactions contemplated hereby.

SECTION 7.  TERMINATION OF OBLIGATIONS TO EFFECT CLOSING; EFFECTS.
7.1    The obligations of the Company, on the one hand, and the Purchaser, on the other hand, to effect the Closing shall terminate as follows:
(a)    By the Purchaser if any of the conditions set forth in Section 6.1 shall have become incapable of fulfillment with respect to the Company and shall not have been waived by the Purchaser, prior to the Closing Date; provided, however, that if the failure of any such condition is a result of any curable breach by the Company of this Agreement, such breach has not been cured by the earlier of 10 days after the giving of written notice by the Purchaser to the Company of the breach.

20

(b)    By the Company if any of the conditions set forth in Section 6.2 shall have become incapable of fulfillment with respect to the Purchaser, and shall not have been waived by the Company, prior to the Closing Date; provided, however, that if the failure of any such condition is a result of any curable breach by the Purchaser of this Agreement, such breach has not been cured by the earlier of 10 days after the giving of written notice by the Company to the Purchaser of the breach. provided, however, that the right to terminate this Agreement under this Section 7.1 shall not be available to any party whose failure to comply with its obligations under this Agreement has been the cause of or resulted in the failure of the Closing to occur.
7.2    Nothing in this Section 7 shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this Agreement or the other Transaction Documents or to impair the right of any party to compel specific performance by any other party of its obligations under this Agreement or the other Transaction Documents.

SECTION 8.  ADDITIONAL COVENANTS AND AGREEMENTS.
8.1    Nasdaq Listing.  The Company will use commercially reasonable efforts to continue the listing and trading of its Common Stock on the Nasdaq Stock Market and, in accordance, therewith, will use commercially reasonable efforts to comply in all material respects with the Company’s reporting, filing and other obligations under the bylaws or rules of such market or exchange, as applicable. The provisions of this Section 8.1 shall terminate and be of no further force and effect on the date on which the Company’s obligations under the Registration Rights Agreement to register or maintain the effectiveness of any registration covering the Registrable Securities (as such term is defined in the Registration Rights Agreement) shall terminate.
8.2    Information Rights.
(a)    For so long as the Purchaser beneficially owns at least 4,062,292 shares of Common Stock (subject to appropriate adjustment in the event of a stock dividend, stock split, combination or other similar recapitalization affecting the Common Stock), the Purchaser shall be entitled to consult on a quarterly basis with the Company’s officers with respect to the Company’s business and financial matters, including management’s proposed annual operating plans and to review progress in achieving said plans, as well as key operating data relevant to such plans. Consistent with, and subject to, the terms and conditions of Section 220 of the Delaware General Corporation Law, the Purchaser shall be entitled to inspect appropriate books and records of the Company. 
(b)    The Purchaser agrees that it will keep confidential and will not disclose, divulge, or use for any purpose (other than to monitor its investment in the Company pursuant to this Agreement) any confidential information obtained from the Company pursuant to the terms of this Agreement, including Section 8.2(a), unless such confidential information is known or becomes known to the public in general (other than as a result of a breach of this Section 8.2(b) by the Purchaser).
(c)    The Purchaser acknowledges that money damages would not be a sufficient remedy for any breach of Section 8.2(b) and consents to a court of competent jurisdiction entering 

21

an order finding that the Company has been irreparably harmed as a result of any such breach and to the granting of injunctive relief without proof of actual damages as a remedy for any such breach.  Such remedies shall not be deemed to be the exclusive remedies for such breach, but shall be in addition to all other remedies available at law or equity to the Company.
8.3    Form D.  The Company agrees to timely file a Form D with respect to the Shares and to provide a copy thereof, promptly upon request of the Purchaser.
8.4    Integration. The Company shall not, and shall use its commercially reasonable efforts to ensure that no affiliate of the Company shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the sale of the Shares to the Purchaser, or that will be integrated with the offer or sale of the Shares for purposes of the rules and regulations of any trading market such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction.
8.5    Short Sales and Confidentiality After the Date Hereof. Purchaser covenants that neither it nor any Affiliates acting on its behalf or pursuant to any understanding with it will, directly or indirectly, engage in any transactions in the Company’s securities (including, without limitation, any Short Sales involving the Company’s securities) during the period from the date hereof until the earlier of such time as (i) after the transactions contemplated by this Agreement are first publicly announced by the Company or (ii) this Agreement is terminated in full. Purchaser understands and acknowledges that the Commission currently takes the position that coverage of short sales of shares of the Common Stock “against the box” prior to effectiveness of a resale registration statement with securities included in such registration statement would be a violation of Section 5 of the Securities Act, as set forth in Item 239.10 of the Securities Act Rules Compliance and Disclosure Interpretations compiled by the Office of Chief Counsel, Division of Corporation Finance.
8.6    Use of Proceeds. The Company shall use the net proceeds of the sale of the Shares to fund the costs and expenses of clinical trials and commercialization of its product candidates, as well as for general working capital. The Company shall not use the net proceeds of the sale of the Shares to effect any cash dividend or other form of distribution to any stockholders of the Company.
8.7    Standstill.  During the period beginning from the date of this Agreement and continuing to and including the date 365 days after the date of this Agreement, neither the Purchaser nor any of its Affiliates shall, without the prior approval of the Company, directly or indirectly:
(a)    purchase, offer to purchase, or agree to purchase or otherwise acquire “beneficial ownership” (as defined in Rule 13d-3 and Rule 13d-5 under the Exchange Act) of any Common Stock or Common Stock Equivalents.
(b)    make, or in any way participate in, any solicitation of proxies to vote, or seek to advise or influence any person with respect to the voting of, any voting securities of the Company or any of its subsidiaries, or seek or propose to influence, advise, change or control the Board, 

22

management, policies, affairs or strategy of the Company by way of any public communication or other communications to security holders intended for such purpose. 
(c)    form, join or in any participate in a “group” (within the meaning of Section 13(d) of the Exchange Act) with respect to any voting securities of the Company.
(d)    make a proposal for, or offer of (with or without conditions) any acquisition of or extraordinary transaction involving the Company or any of the Company’s subsidiaries or any of their respective securities or assets. 
(e)    effect or seek to effect (including, without limitation, by entering into discussions, negotiations, agreements or understandings with any third person), offer or propose (whether publicly or otherwise) to effect, or cause or participate in, or in any way assist or facilitate any other person to effect or seek, offer or propose (whether public or otherwise) to effect or participate (except as a holder of Common Stock) in a merger, consolidation, division, acquisition or exchange of substantially all assets or equity, Change of Control, recapitalization, restructuring, liquidation or similar transaction involving the Company or any of its subsidiaries.
(f)    enter into any discussions, negotiations, arrangements or understandings with or form a group with, any third party in connection with such third party’s taking, planning to take, or seeking to take any of the actions prohibited by clauses (a) through (d) of this Section or otherwise act, alone or in concert with others, to seek to control or influence the Board or the management or policies of the Company, including its subsidiaries.
Notwithstanding the foregoing: (A) nothing in this Agreement shall prohibit the Purchaser or any of its Affiliates from (i) submitting to the Board or to management of the Company a confidential proposal for a transaction involving a Change of Control or other proposed action, provided that neither the Company nor the Purchaser or any of its Affiliates is required to publicly disclose the fact that such proposal or request to consider such a proposal was made or (ii) exercising its rights under the Transaction Documents, including the Registration Rights Agreement; (B) if any executive officer or director of the Purchaser serves as a member of the Company’s Board, any action he or she takes in the performance of his or her duties as a member of the Company’s board of directors shall not be deemed to violate this Section; (C) nothing in this Agreement shall limit the ability of the Purchaser or any of its Affiliates to freely vote or transfer (subject to Section 8.8 below) its Common Stock; and (D) the provisions of this Section shall terminate and be of no further force or effect if (i) the Company publicly announces the entry into a definitive agreement for the acquisition of the Company or more than fifty percent (50%) of its consolidated assets by a Third Party, or (ii) any person commences a tender or exchange offer with respect to the securities representing fifty percent (50%) or more of the voting power of the Company, unless the Company files a recommendation statement under Rule 14d-9 of the Exchange Act (or such successor provision) with the SEC within then (10) Business Days following commencement of such offer advising the Company’s stockholders to reject such offer (provided that if any transaction referred to in the foregoing clauses (i) and (ii) is terminated or abandoned, then the provisions of this Section shall again become effective).

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8.8    Transfer Restrictions. 
(a)    During the period beginning from the date of this Agreement and continuing to and including the earliest of: (A) the date of the expiration or early termination of the License Agreement, or (B) the date 365 days after the date of this Agreement (the “Restricted Period”), the Purchaser shall not, and shall cause its Affiliates not to, without the prior consent of the Company, directly or indirectly, Transfer (i) any shares of Common Stock or Common Stock Equivalents beneficially owned by the Purchaser or any of its Affiliates as of the Closing Date, together with any Common Stock or Common Stock Equivalents issued in respect thereof as a result of any stock split, stock dividend, share exchange, merger, consolidation or similar recapitalization, or (ii) any shares of Common Stock or Common Stock Equivalents issued as (or issuable upon the exercise of any warrant, right or other security that is issued as) a dividend or other distribution with respect to, or in exchange or in replacement of, the Common Stock or Common Stock Equivalents described in clause (i) of this sentence. 
(b)    Notwithstanding anything to the contrary in Section 8.8(a), each of the Purchaser and its Affiliates shall be permitted to Transfer any portion or all of its shares of Common Stock or Common Stock Equivalents during the Restricted Period (i) to a Permitted Transferee, provided that such Permitted Transferee shall sign and deliver a lock-up letter with terms substantially similar to the terms of this Section 8.8, (ii) to the Company or a subsidiary of the Company, (iii) in response to a merger, tender or exchange offer or other business combination, acquisition of assets or similar transaction entered into by the Company or any transaction resulting in a Change of Control of the Company or (iv) as otherwise provided in this Agreement.
8.9    Purchaser Required Disclosures and Transaction Announcement.
(a)    Notwithstanding anything to the contrary in this Agreement but nevertheless subject to Section 8.2(b) of this Agreement, the Purchaser shall always be entitled to make disclosures as required by law, regulation or rules, including stock exchange rules, or by any order of court or other competent authority or tribunal. In the event that the Purchaser would be required to make any such disclosure, the Purchaser agrees to give the Company notice as soon as reasonably possible prior to any such disclosure (to the extent legally permitted and reasonably practicable), to enable the Company to seek an appropriate protective order or other remedy. 
(b)    As soon as possible after signing of the Transaction Documents and License Agreement, the Purchaser shall be entitled to make such announcements as are required by law, regulation and rules, including stock exchange rules.
(c)    The parties hereto shall cooperate to ensure that announcement of the transactions contemplated by the Transaction Documents and License Agreement takes place as soon as possible after signing of such agreements and that the respective disclosures and announcements by such parties are aligned in respect of the timing and content of such announcement, in each case to the extent legally permissible. If either party seeks to redact from public disclosure certain confidential information within the Transaction Documents or the License Agreement, the other party will use commercially reasonable efforts to accommodate such redaction 

24

requests, to the extent permitted under applicable law, regulation and rules, including stock exchange rules.

SECTION 9.  INDEMNIFICATION.
9.1    Indemnification by the Company.   The Company agrees to indemnify and hold harmless the Purchaser, the officers, directors, partners, members, and employees of the Purchaser, each Person who controls any such Purchaser (within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act) and the officers, directors, partners, members and employees of each such controlling Person (each, an “Indemnified Party”), against any losses, claims, damages, liabilities or expenses, joint or several, to which such Indemnified Party may become subject under the Securities Act, the Exchange Act, or any other federal or state statutory law or regulation (including in settlement of any litigation, if such settlement is effected with the written consent of the Company), insofar as such losses, claims, damages, liabilities or expenses (or actions in respect thereof as contemplated below) arise out of or are based in whole or in part on the inaccuracy in the representations and warranties of the Company contained in this Agreement or the failure of the Company to perform its obligations hereunder, and will reimburse each Indemnified Party for legal and other expenses reasonably incurred as such expenses are reasonably incurred by such Indemnified Party in connection with investigating, defending, settling, compromising or paying such loss, claim, damage, liability, expense or action; provided, however, that the Company will not be liable in any such case to the extent that any such loss, claim, damage, liability or expense arises out of or is based upon (i) the failure of such Indemnified Party to comply with the covenants and agreements contained herein, or (ii) the inaccuracy of any representations made by such Indemnified Party herein.
9.2    Indemnification Procedure.   Promptly after any Indemnified Party has received notice of any indemnifiable claim hereunder, or the commencement of any action, suit or proceeding by a third Person, which the Indemnified Party believes in good faith is an indemnifiable claim under this Agreement, the Indemnified Party shall give the indemnitor hereunder (the “Indemnifying Party”) written notice of such claim or the commencement of such action, suit or proceeding, but failure to so notify the Indemnifying Party will not relieve the Indemnifying Party from any liability it may have to such Indemnified Party hereunder except to the extent that the Indemnifying Party is materially prejudiced by such failure. Such notice shall state the nature and the basis of such claim to the extent then known. The Indemnifying Party shall have the right to defend and settle, at its own expense and by its own counsel who shall be reasonably acceptable to the Indemnified Party, any such matter as long as the Indemnifying Party pursues the same diligently and in good faith. If the Indemnifying Party undertakes to defend or settle, it shall promptly notify the Indemnified Party of its intention to do so, and the Indemnified Party shall cooperate with the Indemnifying Party and its counsel in all commercially reasonable respects in the defense thereof and the settlement thereof. Such cooperation shall include, but shall not be limited to, furnishing the Indemnifying Party with any books, records and other information reasonably requested by the Indemnifying Party and in the Indemnified Party’s possession or control. Such cooperation of the Indemnified Party shall be at the cost of the Indemnifying Party. After the Indemnifying Party has notified the Indemnified Party of its intention to undertake to defend or settle any such asserted liability, and for so long as the Indemnifying Party diligently pursues such defense, the Indemnifying 

25

Party shall not be liable for any additional legal expenses incurred by the Indemnified Party in connection with any defense or settlement of such asserted liability; provided, however, that the Indemnified Party shall be entitled (a) at its expense, to participate in the defense of such asserted liability and the negotiations of the settlement thereof and (b) if (i) the Indemnifying Party has failed to assume the defense or employ counsel reasonably acceptable to the Indemnified Party or (ii) if the defendants in any such action include both the Indemnified Party and the Indemnifying Party and counsel to the Indemnified Party shall have concluded that there may be reasonable defenses available to the Indemnified Party that are different from or in addition to those available to the Indemnifying Party or if the interests of the Indemnified Party reasonably may be deemed to conflict with the interests of the Indemnifying Party, then the Indemnified Party shall have the right to select a separate counsel and to assume such legal defense and otherwise to participate in the defense of such action, with the expenses and fees of such separate counsel and other expenses related to such participation to be reimbursed by the Indemnifying Party as incurred. Notwithstanding any other provision of this Agreement, the Indemnifying Party shall not settle any indemnified claim without the consent of the Indemnified Party, unless the settlement thereof imposes no liability or obligation on, and includes a complete release from liability of, and does not include any admission of wrongdoing or malfeasance by, the Indemnified Party.

SECTION 10.  NOTICES.
All notices, requests, consents and other communications hereunder shall be in writing, shall be sent by confirmed electronic mail, or mailed by first-class registered or certified airmail, or nationally recognized overnight express courier, postage prepaid, and addressed as follows:
if to the Company, to:
Selecta Biosciences, Inc.
480 Arsenal Way
Watertown, MA 02472
Attention: Elona Kogan
Email: ekogan@selectabio.com
with a copy (which shall not constitute notice) to:
Gibson, Dunn & Crutcher LLP
555 Mission St. 
San Francisco, CA 94105
Attention: Ryan A. Murr
Email: rmurr@gibsondunn.com
or to such other Person at such other place as the Company shall designate to the Purchaser in writing; and if to the Purchaser, at the address as set forth at the end of this Agreement, or at such other address or addresses as may have been furnished to the Company in writing.

SECTION 11.  MISCELLANEOUS.

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11.1    Waivers and Amendments.   Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively), only with the written consent of the Company and the Purchaser.
11.2    Headings.   The headings of the various sections of this Agreement have been inserted for convenience of reference only and shall not be deemed to be part of this Agreement.
11.3    No Third-Party Beneficiaries.   This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.
11.4    Severability.   Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof but shall be interpreted as if it were written so as to be enforceable to the maximum extent permitted by applicable law, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction. To the extent permitted by applicable law, the parties hereby waive any provision of law which renders any provision hereof prohibited or unenforceable in any respect. 
11.5    Replacement of Certificates.   If the Shares are certificated and any certificate or instrument evidencing any Shares are mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof, or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company and the Company’s transfer agent of such loss, theft or destruction and the execution by the holder thereof of a customary lost certificate affidavit of that fact and an agreement to indemnify and hold harmless the Company and the Company’s transfer agent for any losses in connection therewith or, if required by the transfer agent, a bond in such form and amount as is required by the transfer agent.  The applicants for a new certificate or instrument under such circumstances shall also pay any reasonable third-party costs associated with the issuance of such replacement Shares.  If a replacement certificate or instrument evidencing any Shares is requested due to a mutilation thereof, the Company may require delivery of such mutilated certificate or instrument as a condition precedent to any issuance of a replacement.
11.6    Governing Law; Consent to Jurisdiction; Waiver of Jury Trial.   This Agreement will be governed by and construed in accordance with the laws of the State of Delaware without regard to any choice of laws or conflict of laws provisions that would require the application of the laws of any other jurisdiction. The parties hereby irrevocably and unconditionally consent to submit to the exclusive jurisdiction of Delaware Court of Chancery and any state appellate court therefrom within the State of Delaware (or, if the Delaware Court of Chancery declines to accept jurisdiction over a particular matter, any state or federal court within the State of Delaware) for any actions, suits or proceedings arising out of or relating to this Agreement and the transactions contemplated hereby. Each party to this Agreement hereby irrevocably waives any defense in any such action, suit or proceeding that it is not personally subject to the jurisdiction of the above named courts and to the fullest extent permitted by applicable law, that the action, suit or proceeding in any such court 

27

is brought in an inconvenient forum or that the venue of such suit, action or proceeding is improper. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT AND THE OTHER TRANSACTION DOCUMENTS OR THE TRANSACTIONS CONTEMPLATED HEREBY AND THEREBY.
11.7    Counterparts.   This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and, all of which taken together shall constitute one and the same Agreement and shall become effective when counterparts have been signed by each party and delivered to the other party, it being understood that both parties need not sign the same counterpart.  In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) the same with the same force and effect as if such facsimile of “.pdf” signature were the original thereof.
11.8    Successors and Assigns.   Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties hereto.
11.9    Entire Agreement.   This Agreement and other documents delivered pursuant hereto, including the exhibit and the Schedule of Exceptions, the License Agreement and the other Transaction Documents constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof and thereof.
11.10    Payment of Fees and Expenses.   Each of the Company and the Purchaser shall bear its own expenses and legal fees incurred on its behalf with respect to this Agreement and the transactions contemplated hereby. If any action at law or in equity is necessary to enforce or interpret the terms of this Agreement, the prevailing party shall be entitled to reasonable attorney’s fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled.
11.11    Survival.   Subject to applicable statutes of limitations, the representations, warranties, covenants, and agreements contained in this Agreement shall survive the Closing for a period of two years after the date hereof and thereafter shall thereafter have no further force and effect.
[signature page follows]

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the day and year first above written.
	
			
	 
	SELECTA BIOSCIENCES, INC.

	 
	 
	 

	 
	By:
	/s/ Carsten Brunn, Ph.D.

	 
	Name:
	Carsten Brunn, Ph. D.

	 
	Title:
	President and Chief Executive Officer

	 
	 
	 

	 
	 
	 

	 
	SWEDISH ORPHAN BIOVITRUM AB (PUBL)

	 
	By:
	/s/ Guido Oelkers

	 
	Name:
	Guido Oelkers

	 
	Title:
	CEO

	 
	 
	 

	 
	 
	 

	 
	By:
	/s/ Torbjӧrn Hallberg

	 
	Name:
	Torbjӧrn Hallberg

	 
	Title:
	General Counsel

[Signature Page To Stock Purchase Agreement]

EXHIBIT A
PURCHASE INFORMATION
	
		
	Name
	Swedish Orphan Biovitrum AB (publ)

	Address
	Tomtebodavägen 23A, SE-112 76 Stockholm, Sweden

	Numbers of Shares to be Purchased*
	5,416,390

	Closing Purchase Amount
	$25,000,000 USD

		
	*
	Subject to appropriate adjustment in the event of a stock dividend, stock split, combination or other similar recapitalization affecting the Common Stock.

EXHIBIT B
SCOPE OF OPINION
1.    The Company is a validly existing corporation in good standing under the laws of the State of Delaware and is qualified to do business as a foreign corporation in and is in good standing under the laws of the State of Massachusetts.
2.    The Company has authorized 200,000,000 shares of Common Stock, par value $0.0001 per share.  The Shares have been duly authorized and, when issued and delivered to and paid for by the Purchaser in accordance with the terms of the Purchase Agreement, will be validly issued, fully paid and non-assessable and free of preemptive or similar rights arising under the Company’s Certificate of Incorporation or Bylaws.
3.    The Company has all requisite corporate power and authority to (i) issue, sell and deliver the Shares pursuant to the Transaction Documents, (ii) execute and deliver the Transaction Documents and (iii) to carry out and perform its obligations under the Transaction Documents.  The Transaction Documents have been duly and validly executed and delivered by the Company.
4.    The execution and delivery by the Company of the Transaction Documents, the performance of its obligations thereunder, and the issuance by the Company of the Shares to the Purchaser:
(i)    do not and will not violate the charter or bylaws of the Company;
(ii)    based solely upon review of such agreements, do not and will not result in a breach of or default under any agreement to which the Company is a party that is identified to us in a certificate of the Company as being material to the Company and its subsidiaries taken as a whole, which agreements are listed on Annex A1; and 
(iii)    do not and will not (A) violate any law, rule or regulation of the State of New York or the United States of America applicable to the Company that, in our experience, is generally applicable to transactions in the nature of those contemplated by the Transaction Documents, (B) violate the Delaware General Corporation Law, or (C) require any filing with or approval of any governmental authority or regulatory body of (a) the State of New York or the United States of America under any law or regulation currently in effect of the State of New York or the United States of America applicable to the Company that, in our experience, is generally applicable to transactions in the nature of those contemplated by the Transaction Documents, or (b) the State of Delaware under the Delaware General Corporation Law, except for such filings or approvals as already have been made or obtained and except for the filing of a Notice of Exempt Offering of Securities on Form D, filed under Regulation D under the Securities Act.
5.    Assuming the accuracy of the representations and the Purchaser’s compliance with the covenants made by the Purchaser in the Transaction Documents, the offering, sale and issuance of the Shares to the Purchaser pursuant to the Transaction Documents is exempt from registration under the Securities Act. 
_______________________
1 To include indentures, loan agreements, mortgages, leases and other material agreements filed with the SEC.

6.    The Company is not and, after giving effect to the sale of the Shares in accordance with the Transaction Documents, will not be an “investment company” that is required to be registered under the Investment Company Act of 1940, as amended.

APPENDIX I
SELLING STOCKHOLDER QUESTIONNAIRE

APPENDIX II
REGISTRATION RIGHTS AGREEMENT

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