Document:

EX-10.26

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  Exhibit 10.26

   

  	
	 

	__________________________________________
ROADRUNNER SOLUTIONS LLC
__________________________________________
 
 
 

	FORM OF AMENDED AND RESTATED LIMITED LIABILITY COMPANY AGREEMENT
 
Dated as of March 10, 2022
 
THE UNITS ISSUED PURSUANT TO THIS AMENDED AND RESTATED LIMITED LIABILITY COMPANY AGREEMENT HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR UNDER ANY OTHER APPLICABLE SECURITIES LAWS.  SUCH UNITS MAY NOT BE SOLD, TRANSFERRED, ASSIGNED, PLEDGED OR OTHERWISE DISPOSED OF AT ANY TIME WITHOUT EFFECTIVE REGISTRATION UNDER SUCH ACT AND LAWS OR AN EXEMPTION THEREFROM, AND COMPLIANCE WITH THE OTHER RESTRICTIONS ON TRANSFERABILITY SET FORTH HEREIN.
 

	 

   

  LW 128780978

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  Table of Contents

  			
	ARTICLE I
	DEFINITIONS
	2

	Section 1.01.
	Definitions
	2

	ARTICLE II
	ORGANIZATIONAL MATTERS
	11

	Section 2.01.
	Formation of LLC
	11

	Section 2.02.
	Limited Liability Company Agreement
	11

	Section 2.03.
	Name
	11

	Section 2.04.
	Purpose
	11

	Section 2.05.
	Principal Office; Registered Office
	11

	Section 2.06.
	Term
	12

	Section 2.07.
	Tax Treatment
	12

	Section 2.08.
	No State-Law Partnership
	12

	ARTICLE III
	UNITS, CAPITAL CONTRIBUTIONS AND CAPITAL ACCOUNTS
	12

	Section 3.01.
	Units
	12

	Section 3.02.
	Issuance of Additional Units and Interests
	13

	Section 3.03.
	Preemptive Rights
	13

	Section 3.04.
	Capital Accounts
	14

	Section 3.05.
	Allocations of Profits and Losses
	14

	Section 3.06.
	Income Tax Allocations
	16

	ARTICLE IV
	DISTRIBUTIONS
	16

	Section 4.01.
	Distributions
	16

	Section 4.02.
	Tax Distributions
	17

	Section 4.03.
	Withholding
	17

	ARTICLE V
	GOVERNANCE
	18

	Section 5.01.
	Authority
	18

	Section 5.02.
	Composition of the Board
	18

   

  i

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  			
	Section 5.03.
	Board Actions; Meetings
	19

	Section 5.04.
	Delegation of Authority
	23

	Section 5.05.
	Purchase of Units
	23

	Section 5.06.
	Officers
	23

	Section 5.07.
	Limitations
	24

	ARTICLE VI
	RIGHTS AND OBLIGATIONS OF UNITHOLDERS
	24

	Section 6.01.
	Limitation of Liability
	25

	Section 6.02.
	Lack of Authority
	25

	Section 6.03.
	No Right of Partition
	25

	Section 6.04.
	Indemnification
	25

	Section 6.05.
	Unitholders’ Right to Act
	27

	Section 6.06.
	Investment Opportunities and Conflicts of Interest
	27

	Section 6.07.
	Confidentiality
	28

	Section 6.08.
	Non-Solicitation
	29

	ARTICLE VII
	RECORDS, ACCOUNTING; INSPECTION
	29

	Section 7.01.
	Records and Accounting
	29

	Section 7.02.
	Transmission of Communications
	30

	ARTICLE VIII
	TAX MATTERS
	30

	Section 8.01.
	Preparation of Tax Returns
	30

	Section 8.02.
	Tax Controversies
	30

	Section 8.03.
	Section 754 Election
	31

	ARTICLE IX
	TRANSFER OF UNITS
	31

	Section 9.01.
	Required Consent
	31

	Section 9.02.
	Tag Along Rights
	31

	Section 9.03.
	Approved Sale; Drag Along Obligations
	32

	Section 9.04.
	Put Option; Call Option
	34

   

  ii

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  			
	Section 9.05.
	Rights upon a Change of Control of HMI
	35

	Section 9.06.
	Effect of Assignment
	35

	Section 9.07.
	Transfer Fees and Expenses
	36

	Section 9.08.
	Void Transfers
	36

	Section 9.09.
	Section 7704 Limits
	36

	ARTICLE X
	ADMISSION OF UNITHOLDERS
	37

	Section 10.01.
	Substituted Unitholders
	37

	Section 10.02.
	Additional Unitholders
	37

	ARTICLE XI
	WITHDRAWAL OF UNITHOLDERS
	37

	Section 11.01.
	Withdrawal of Unitholders
	37

	ARTICLE XII
	DISSOLUTION AND LIQUIDATION
	37

	Section 12.01.
	Dissolution
	37

	Section 12.02.
	Liquidation and Termination
	38

	Section 12.03.
	Securityholders Agreement
	38

	Section 12.04.
	Cancellation of Certificate
	39

	Section 12.05.
	Reasonable Time for Winding Up
	39

	Section 12.06.
	Hart Scott Rodino
	39

	ARTICLE XIII
	VALUATION
	39

	Section 13.01.
	Valuation of Units
	39

	Section 13.02.
	Valuation of Securities
	39

	Section 13.03.
	Valuation of Other Assets
	39

	Section 13.04.
	Dispute Resolution
	40

	ARTICLE XIV
	GENERAL PROVISIONS
	40

	Section 14.01.
	Amendments
	40

	Section 14.02.
	Title to Company Assets
	40

	Section 14.03.
	Remedies
	41

   

  iii

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  			
	Section 14.04.
	Successors and Assigns
	41

	Section 14.05.
	Severability
	41

	Section 14.06.
	Counterparts; Binding Agreement
	41

	Section 14.07.
	Descriptive Headings; Interpretation
	41

	Section 14.08.
	Applicable Law; Jurisdiction; Service of Process
	42

	Section 14.09.
	Addresses and Notices
	42

	Section 14.10.
	Creditors
	42

	Section 14.11.
	No Waiver
	43

	Section 14.12.
	Further Action
	43

	Section 14.13.
	Escrow for Disputed Amounts
	43

	Section 14.14.
	Entire Agreement
	43

	Section 14.15.
	Delivery by Electronic Means
	43

	Section 14.16.
	Survival
	43

	Section 14.17.
	WAIVER OF JURY TRIAL
	43

	Section 14.18.
	No Strict Construction
	44

   

   

  iv

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  AMENDED AND RESTATED LIMITED LIABILITY COMPANY AGREEMENT

  THIS AMENDED AND RESTATED LIMITED LIABILITY COMPANY AGREEMENT of the Company is entered into as of March 10, 2022 (the “Effective Date”) by and among Roadrunner Solutions LLC, a Delaware limited liability company (the “Company”), Homology Medicines, Inc., a Delaware corporation (“HMI”), and Oxford Biomedica (US), Inc., a Delaware corporation (“OXB”).  Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in ARTICLE I.

  WHEREAS, (i) the Company was formed on January 25, 2022 as a limited liability company in accordance with the Delaware Act and (ii) immediately prior to the execution of this Agreement, the Company was governed by that certain Limited Liability Company Agreement of the Company dated as of January 25, 2022 (the “Prior Agreement”);

  WHEREAS, prior to the execution of this Agreement, HMI and the Company entered into a contribution agreement (the “Contribution Agreement”) pursuant to which, among other things, on the terms and subject to the conditions set forth therein, and effective immediately prior to the Closing, (a) HMI assigned and transferred to the Company the Transferred Assets (as defined in the Contribution Agreement), and the Company assumed from HMI, and agreed to pay, perform and discharge when due, the Transferred Liabilities (as defined in the Contribution Agreement) and (b) in exchange therefor, the Company issued to HMI 175,000 of the Company’s Units;

  WHEREAS, on the terms and subject to the conditions set forth in that certain Equity Securities Purchase Agreement, dated as of January 28, 2022, by and among HMI, the Company and OXB (the “Purchase Agreement”), HMI will sell to OXB, and OXB will purchase from HMI, 130,000 Units in exchange for a cash payment by OXB to HMI at the Closing in the amount of $130,000,000;

  WHEREAS, on the terms and subject to the conditions set forth in the Purchase Agreement, and effective as of the Closing, the Company will issue to OXB, and OXB will purchase from the Company 50,000 Units in exchange for a cash contribution by OXB to the Company of $50,000,000;

  WHEREAS, immediately following the consummation of the Contribution and contemporaneously with the execution of this Agreement, the Equity Transfer (as defined in the Purchase Agreement) and the Equity Issuance (as defined in the Purchase Agreement) will be consummated in accordance with the Purchase Agreement, pursuant to which (a) OXB will own, in the aggregate, 180,000 Units, collectively representing 80% of the outstanding Units, and (b) HMI will own, in the aggregate, 45,000 Units, collectively representing 20% of the outstanding Units, in each case, as reflected on the Unit Ownership Ledger; and

  WHEREAS, in connection with the admission of certain Unitholders at the closing of the transactions contemplated by the Purchase Agreement, the Unitholders desire to amend and restate the Prior Agreement in its entirety.

  NOW, THEREFORE, in consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Unitholders, intending to be legally bound, hereby agree as follows:

   

  LW 128780978

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  ARTICLE I
DEFINITIONS

  Section 1.01.	Definitions.  Capitalized terms used but not otherwise defined herein shall have the following meanings:

  “Additional Unitholder” means a Person admitted to the Company as a Unitholder pursuant to Section 10.02.

  “Admission Date” has the meaning set forth in Section 9.06(a).

  “Affiliate” of any Person means any other Person controlled by, controlling or under common control with such Person.  As used in this definition, “control” (including, with its correlative meanings, “controlling,” “controlled by” and “under common control with”) shall mean possession, directly or indirectly, of power to direct or cause the direction of management or policies (whether through ownership of securities, by contract or otherwise).  For purposes of this Agreement, the Company and its Subsidiaries shall not be deemed to be Affiliates of any Unitholder.

  “Agreement” means this Amended and Restated Limited Liability Company Agreement, as it may be amended, modified and/or waived from time to time in accordance with the terms hereof.

  “Allocation Period” means the Fiscal Year or such other taxable period for which any allocation of items of income, gain, loss, deduction or credit is required to be calculated.

  “Alternative Indemnitors” has the meaning set forth in Section 6.04(c).

  “Approved Sale” has the meaning set forth in Section 9.03(a).

  “Assignee” means a Person to whom Units have been Transferred in accordance with the terms of this Agreement and the other agreements contemplated hereby, as applicable, but who has not become a Unitholder pursuant to ARTICLE X.

  “Assumed Tax Rate” means the highest effective marginal combined federal, state and local tax rate (including the net investment income tax imposed under Section 1411 of the Code) generally applicable to a corporation subject to tax in the jurisdictions in which the Company conducts business.  When applying the Assumed Tax Rate hereunder, the Board shall take into account the character of the income and, to the extent the Board reasonably determines such benefits are available, the deductibility of state and local income taxes, and loss carry forwards. 

  “Available Cash” shall mean, as of any date, the excess of (i) the unrestricted cash and cash equivalent items held by the Company over (ii) the sum of the amount of such items reasonably determined in good faith by the Board to be reasonably necessary for the payment of the Company’s expenses, liabilities and other obligations (whether fixed or contingent), and for the establishment of appropriate reserves for such expenses, liabilities and obligations as may reasonably be expected to arise, including the maintenance of adequate working capital for the continued conduct of the Company’s business.

  “Bankruptcy” means, with respect to any Person, the time (i) a court or Governmental Authority having jurisdiction shall enter a decree or order for relief in respect of such Person in an involuntary case under any applicable bankruptcy, insolvency or other similar law, or appointing a receiver, liquidator, assignee, custodian, trustee, sequestrator (or similar official) of such Person or for any substantial part of its property or ordering the winding up or liquidation of any of its affairs; or (ii) such Person shall 

  2

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  commence a voluntary case under any applicable bankruptcy, insolvency or other similar law, or consent to the entry of an order for relief in an involuntary case under any such law, or consent to the appointment or taking possession by a receiver, liquidator, assignee, custodian, trustee, sequestrator (or similar official) of such Person or for any substantial part of any its property or make any general assignment for the benefit of its creditors.

  “Board” means the Board of Directors of the Company established pursuant to Section 5.02, which shall have the power and authority described in this Agreement.

  “Book Liability Value” means with respect to any liability of the Company described in Treasury Regulation Section 1.752-7(b)(3)(i), the amount of cash that a willing assignor would pay to a willing assignee to assume such liability in an arm’s length transaction. The Book Liability Value of each liability of the Company described in Treasury Regulation Section 1.752-7(b)(3)(i) shall be adjusted at such times as provided in this Agreement for an adjustment to Book Value; provided, however, that such adjustments shall be made only if the Board reasonably determines that such adjustments are necessary or appropriate to reflect the relative economic interests of the Unitholders in the Company. 

  “Book Value” means, with respect to any property of the Company, such property’s adjusted basis for federal income tax purposes, except as follows:

  (a)	The initial Book Value of any property contributed by a Unitholder to the Company shall be the Fair Market Value of such property as of the date of contribution as reasonably determined by the Board in good faith (and in accordance with ARTICLE XIII);

  (b)	The Book Values of all properties shall be adjusted to equal their respective Fair Market Values as reasonably determined by the Board in good faith (and in accordance with ARTICLE XIII) in connection with (i) the acquisition of an interest (or additional interest) in the Company by any new or existing Unitholder in exchange for more than a de minimis capital contribution to the Company, (ii) the Distribution by the Company to a Unitholder of more than a de minimis amount of property as consideration for an interest in the Company, (iii) the liquidation of the Company within the meaning of Treasury Regulation Section 1.704-1(b)(2)(ii)(g)(1), (iv) the acquisition of an interest in the Company by any new or existing Unitholder upon the exercise of a non-compensatory option or warrant, (v) the acquisition of an interest in the Company by any new or existing Unitholder as consideration for the provision of services to or for the benefit of the Company or (vi) any other event to the extent reasonably determined by the Board in good faith to be permitted and necessary to properly reflect Book Values in accordance with the standards set forth in Treasury Regulation Section 1.704-1(b)(2)(iv)(q); provided, however, that adjustments pursuant to clauses (i), (ii), (v) and (vi) above shall be made only if the Board in good faith reasonably determines that such adjustments are necessary or appropriate to reflect the relative economic interests of the Unitholders in the Company. If any non-compensatory options or warrants are outstanding upon the occurrence of an event described in this paragraph (b)(i) through (b)(vi), the Company shall adjust the Book Values of its properties in accordance with Treasury Regulation Sections 1.704-1(b)(2)(iv)(f)(1) and 1.704-1(b)(2)(iv)(h)(2);

  (c)	The Book Value of property distributed to a Unitholder shall be adjusted to equal the Fair Market Value of such property as of the date of Distribution (as determined pursuant to ARTICLE XIII);

  (d)	The Book Value of all property shall be increased (or decreased) to reflect any adjustments to the adjusted basis of such property pursuant to Section 734(b) or Section 743(b) of the Code, but only to the extent that such adjustments are taken into account in determining Capital Accounts pursuant to Treasury Regulation Section 1.704-1(b)(2)(iv)(m) and clause (g) of the definition of Profits and Losses 

  3

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  or Section 3.05(b)(vi); provided, however, that Book Value shall not be adjusted pursuant to this clause (d) to the extent the Board in good faith reasonably determines that an adjustment pursuant to clause (b) of this definition is necessary or appropriate in connection with the transaction that would otherwise result in an adjustment pursuant to this clause (d);

  (e)	If the Book Value of property has been determined or adjusted pursuant to clause (b) or (d) of this definition, such Book Value shall thereafter be adjusted by the Depreciation taken into account with respect to such property for purposes of computing Profits and Losses and other items allocated pursuant to ARTICLE III. 

  “Business” means the business of the manufacturing of adeno-associated virus vectors for use in gene therapy or gene editing products.

  “Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or the United Kingdom or any day on which banking institutions in New York City or London, United Kingdom are authorized or required by law or other governmental action to close.

  “Business Opportunities” has the meaning set forth in Section 6.06.

  “Capital Account” means the capital account maintained for a Unitholder pursuant to Section 3.04 and the other applicable provisions of this Agreement.

  “Capital Contributions” means any cash, cash equivalents or the Fair Market Value of other property that a Unitholder contributes or is deemed by the Board to have contributed to the Company with respect to any Unit pursuant to Section 3.01 or Section 3.02, net of any liabilities assumed by the Company for such Unitholder in connection with such contribution and net of any liabilities to which the assets contributed by such Unitholder are subject.

  “CEO” has the meaning set forth in Section 5.02(a)(iii).

  “Certificate” means the Company’s Certificate of Formation as filed with the Secretary of State of Delaware, as the same may be amended from time to time.

  “Chosen Courts” has the meaning set forth in Section 14.08.

  “Closing Date” means March 10, 2022.

  “Code” means the United States Internal Revenue Code of 1986, as amended.

  “Common Unit” means a Unit having the rights and obligations specified with respect to a Common Unit in this Agreement.

  “Company” means Roadrunner Solutions LLC, a Delaware limited liability company.

  “Company Group” means the Company and its Subsidiaries.

  “Company Minimum Gain” shall have the meaning ascribed to the term “Partnership Minimum Gain” in the Treasury Regulations Section 1.704-2(d).

  “Court of Chancery” has the meaning set forth in Section 14.08.

  4

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  “Covered Person” means (a) any Unitholder, any Affiliate of a Unitholder, any officers, managers, directors, trustees, shareholders, members, beneficiaries, partners, employees, representatives or agents of any Unitholder or its Affiliates, (b) any non-employee officer, manager or director of the Company or its Subsidiaries and (c) any Partnership Representative or Designated Individual to the extent acting in the capacity as Partnership Representative or Designated Individual, as applicable.

  “Delaware Act” means the Delaware Limited Liability Company Act, 6 Del. L. § 18 101, et seq., as it may be amended from time to time, and any successor thereto.

  “Delaware Federal Court” has the meaning set forth in Section 14.08.

  “Depreciation” means, for each Allocation Period, an amount equal to the depreciation, amortization or other cost recovery deduction (excluding depletion) allowable for federal income tax purposes with respect to property for the Allocation Period, except that (i) with respect to any property the Book Value of which differs from its adjusted tax basis for federal income tax purposes and which difference is being eliminated by use of the remedial allocation method pursuant to Treasury Regulation Section 1.704-3(d), Depreciation for the Allocation Period shall be the amount of book basis recovered for the Allocation Period under the rules prescribed by Treasury Regulation Section 1.704-3(d)(2), and (ii) with respect to any other property the Book Value of which differs from its adjusted tax basis at the beginning of the Allocation Period, Depreciation shall be an amount which bears the same ratio to such beginning Book Value as the federal income tax depreciation, amortization or other cost recovery deduction for the Allocation Period bears to such beginning adjusted tax basis; provided, however, that if the adjusted tax basis of any property at the beginning of the Allocation Period is zero, Depreciation with respect to such property shall be determined with reference to such beginning value using any reasonable method selected by the Board.

  “Director” means a Director serving on the Board at any given time, who, for purposes of the Delaware Act, will be deemed a “manager” (as defined in the Delaware Act), but will be subject to the rights, obligations and limitations set forth in this Agreement.

  “Disputed Amount” means with respect to a particular Indemnification Claim, the amount of such Indemnification Claim with respect to which there remains a dispute between the parties.

  “Dissolution” of a Unitholder which is not a natural person means that such Unitholder has terminated its existence, whether partnership, limited liability company or corporation, wound up its affairs and dissolved; provided that a change in the membership of any Unitholder that is a partnership shall not constitute a “Dissolution” hereunder, whether or not the Unitholder is deemed technically dissolved for partnership law purposes, so long as the business of the Unitholder is continued.

  “Distribution” means each distribution made by the Company to a Unitholder with respect to such Person’s Units, whether in cash, property or securities and whether by interim or liquidating Distribution, redemption, repurchase or otherwise; provided that, without limiting the rights of any Unitholders pursuant to Section 5.03(b) or Section 5.03(c), none of the following shall be deemed to be a Distribution hereunder: (i) any pro rata redemption of Units by the Company or (ii) any recapitalization, exchange or conversion of securities of the Company, and any subdivision (by unit split or otherwise) or any combination (by reverse unit split or otherwise) of any outstanding Units.

  “Electing Unitholders” has the meaning set forth in Section 9.02.

  “Equity Securities” means (i) any Units, capital stock, partnership interests, membership or limited liability company interests or other equity interests (including other classes, groups or series 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  thereof having such relative rights, powers and/or obligations as may from time to time be established by the Board, including rights, powers and/or duties different from, senior to or more favorable than existing classes, groups and series of Units, capital stock, partnership interests, membership or limited liability company interests or other equity interests, and including any profits interests), (ii) obligations, evidences of indebtedness or other securities or interests convertible or exchangeable into Units, capital stock, partnership interests, membership or limited liability company interests or other equity interests, and (iii) warrants, options or other rights to purchase or otherwise acquire Units, capital stock, partnership interests, membership or limited liability company interests or other equity interests.  Unless the context otherwise indicates, the term “Equity Securities” refers to Equity Securities of the Company.

  “Event of Withdrawal” means the death, retirement, resignation, expulsion, Bankruptcy or Dissolution of a Unitholder or the occurrence of any other event that terminates the continued membership of a Unitholder in the Company.

  “Excluded Issuances” means issuances of (i) Common Units on the date hereof, (ii) Equity Securities upon exercise, conversion or exchange of other Equity Securities which were issued in compliance with Section 3.03, (iii) Equity Securities issued by a Subsidiary of the Company to another Subsidiary of the Company or the Company, (iv) Equity Securities issued in connection with any acquisitions involving the Company or any of its Subsidiaries and other Persons that are determined by the Board (including the HMI Director) in good faith to be “strategic” transactions (including Equity Securities issued in connection with joint ventures and similar arrangements), (v) Equity Securities issued to officers, directors, managers, consultants, employees or other service providers to the Company or any of its Subsidiaries, in each case, that are not affiliated with any Unitholder, pursuant to any agreement or any incentive or other compensation plans or agreements approved by the Board, or (vi) Equity Securities issued in connection with any Unit split, Unit Distribution or recapitalization of the Company in which holders of the same class of Units participate on a Pro Rata Basis.

  “Fair Market Value” means, with respect to any asset or Equity Securities, its fair market value determined according to ARTICLE XIII.

  “FCA” means the Financial Conduct Authority of the United Kingdom, or any successor authority or authorities.

  “Fiscal Quarter” means each calendar quarter ending March 31, June 30, September 30 and December 31, or such other quarterly accounting period as may be established by the Board or as required by the Code.

  “Fiscal Year” means the 12-month period ending on December 31, or such other annual accounting period as may be established by the Board or as may be required by the Code.

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

  “Governmental Authority” means any foreign, federal, state, local, county, municipal, provincial, multinational government or other governmental or quasi-governmental authority or regulatory board, court, tribunal, arbitrating body, governmental department, commission, board, body, self-regulating authority, bureau or agency, as well as any other instrumentality or entity designated to act for or on behalf of any of the foregoing and any business entity owned or chartered by any of the foregoing.

  “HSR Act” has the meaning set forth in Section 12.06.

  6

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  “Indemnified Person” has the meaning set forth in Section 6.04(a).

  “Liquidation Assets” has the meaning set forth in Section 12.02(b).

  “Liquidation FMV” has the meaning set forth in Section 12.02(b).

  “Liquidation Statement” has the meaning set forth in Section 12.02(b).

  “London Stock Exchange” means London Stock Exchange plc.

  “Losses” means items of the Company loss and deduction determined by the Board.

  “Maximum Put/Call Amount” [***].

  “Nonrecourse Liability” shall have the meaning set forth in Treasury Regulations Section 1.752-l(a)(2).

  “Offeree Investors” has the meaning set forth in Section 3.03(a).

  “Officers” means each person designated as an officer of the Company to whom authority and duties have been delegated pursuant to Section 5.06, subject to any resolution of the Board appointing or removing such person as an officer or relating to such appointment.

  “Ordinary Shares” means ordinary shares of 50 pence each in the capital of Oxford Biomedica plc.

  “OXB” has the meaning set forth in the preamble.

  “OXB Change of Control” means (i) the sale (in one or a series of related transactions and whether by merger, consolidation, reorganization, combination, sale or transfer of OXB’s or OXB Biomedica plc’s Equity Securities) of all or substantially all of the assets of OXB or OXB Biomedica plc to a third party; or (ii) a sale (in one or a series of related transactions and whether by merger, consolidation, reorganization, combination, sale or transfer of OXB’s or OXB Biomedica plc’s Equity Securities) resulting in more than 50% of the Equity Securities of OXB or OXB Biomedica plc being held by a third party.

  [***].  

  “Permitted Transferee” means, with respect to any Unitholder, any of its controlled Affiliates, or in the case of OXB, Oxford Biomedica plc or any of its controlled Affiliates.

  “Person” means an individual, a partnership, a corporation, a limited liability company, an association, a joint stock company, a trust, a joint venture, an unincorporated organization, association or other entity or a Governmental Authority.

  “Preemptive Rights Notice” has the meaning set forth in Section 3.03(b).

  “Prior Agreement” has the meaning set forth in the recitals of this Agreement.

  “Pro Rata Basis” means, with respect to each Unitholder, and as determined with respect to any particular expense, liability or obligation incurred (or amount of proceeds withheld) in connection with any Transfer of Equity Securities pursuant to Section 9.02 or any Approved Sale, the amount such Unitholder’s proceeds would be reduced as a percentage of the aggregate reduction in proceeds to 

  7

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  applicable Unitholders assuming the Company’s Total Equity Value implied by such Transfer or Approved Sale were being distributed to the Unitholders in accordance with Section 4.01(a) in connection with such Transfer or Approved Sale and as if such expense, liability or obligation were incurred and satisfied (or such amount of proceeds were withheld) prior to such Distribution, as determined in good faith by the Board.

  “Pro Rata Share” means (i) with respect to each Unit, the proportionate amount such Unit would receive if an amount equal to the Total Equity Value were distributed to all Units in accordance with Section 4.01(a), and (ii) with respect to each Unitholder, such Unitholder’s pro rata share of Total Equity Value represented by all Units owned by such Unitholder, in each case, as determined in good faith by the Board.

  “Profits” or “Losses” means, for each Allocation Period, each item of income, gain, loss and deduction entering into the Company’s taxable income or loss for the Allocation Period, determined in accordance with Section 703(a) of the Code (including, for this purpose, all items of income, gain, loss, or deduction required to be stated separately pursuant to Section 703(a)(1) of the Code), with the following adjustments (without duplication):

  (a)	Any income of the Company that is exempt from federal income tax and not otherwise taken into account in computing Profits and Losses pursuant to this definition shall be added to such taxable income or loss;

  (b)	Any expenditures of the Company described in Section 705(a)(2)(B) of the Code or treated as Section 705(a)(2)(B) expenditures pursuant to Treasury Regulations Section 1.704-1(b)(2)(iv)(i) and not otherwise taken into account in computing Profits or Losses pursuant to this definition shall be subtracted from such taxable income or loss;

  (c)	In the event the Book Value of any asset is adjusted pursuant to clause (b) or clause (c) of the definition of Book Value, the amount of such adjustment shall be treated as an item of gain (if the adjustment increases the Book Value of the asset) or an item of loss (if the adjustment decreases the Book Value of the asset) from the disposition of such asset and shall be taken into account for purposes of computing Profits or Losses;

  (d)	Gain or loss resulting from any disposition of property with respect to which gain or loss is recognized for federal income tax purposes shall be computed by reference to the Book Value of the property disposed of, notwithstanding that the adjusted tax basis of such property differs from its Book Value; 

  (e)	In lieu of the depreciation, amortization, and other cost recovery deductions taken into account in computing such taxable income or loss, there shall be taken into account Depreciation for such Allocation Period;

  (f)	To the extent an adjustment to the adjusted tax basis of any asset pursuant to Section 734(b) of the Code is required, pursuant to Treasury Regulations Section 1.704-1(b)(2)(iv)(m)(4), to be taken into account in determining Capital Account balances as a result of a Distribution other than in liquidation of a Unitholder’s interest in the Company, the amount of such adjustment shall be treated as an item of gain (if the adjustment increases the basis of the asset) or an item of loss (if the adjustment decreases such basis) from the disposition of such asset and shall be taken into account for purposes of computing Profits or Losses; 

  8

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  (g)	In the event the Book Liability Value of any liability of the Company described in Treasury Regulations Section 1.752-7(b)(3)(i) is adjusted as required by this Agreement, the amount of such adjustment shall be treated as an item of loss (if the adjustment increases the Book Liability Value of such liability of the Company) or an item of gain (if the adjustment decreases the Book Liability Value of such liability of the Company) and such items, and any other items relating to Book Liability Values determined by the Board to be appropriate in determining Capital Accounts, shall be taken into account for purposes of computing Profits or Losses; and

  (h)	Any items that are allocated pursuant to Section 3.06 shall be determined by applying rules analogous to those set forth in clauses (a) through (g) of this definition but shall not be taken into account in computing Profits and Losses.

  “Purchase Agreement” has the meaning set forth in the Recitals.

  “Required Consent” has the meaning set forth in Section 9.01(a).

  “Sale of the Company” means any transaction or series of related transactions pursuant to which any Person or group of related Persons (other than OXB and/or its Affiliates) in the aggregate acquire(s) (i) Equity Securities of the Company possessing the voting or designation power (other than voting rights accruing only in the event of a default or breach) to elect Board members which, in the aggregate, control a majority of the votes on the Board (whether by merger, consolidation, reorganization, combination, sale or transfer of the Company’s Equity Securities, securityholder or voting agreement, proxy, power of attorney or otherwise) or (ii) all or substantially all of the Company’s assets determined on a consolidated basis.

  “SEC” means the Securities and Exchange Commission of the United States, or any successor authority or authorities. 

  “Selling Unitholders” has the meaning set forth in Section 9.02(a).

  “Specified Persons” has the meaning set forth in Section 6.06.

  “Subsidiary” means, with respect to any Person, any corporation, limited liability company, partnership, association or business entity of which (i) if a corporation, a majority of the total voting power of shares of stock entitled (without regard to the occurrence of any contingency) to vote in the election of directors, managers or trustees thereof is at the time owned or controlled, directly or indirectly, by that Person or one or more of the other Subsidiaries of that Person or a combination thereof, or (ii) if a limited liability company, partnership, association or other business entity (other than a corporation), a majority of partnership or other similar ownership interests thereof is at the time owned or controlled, directly or indirectly, by any Person or one or more Subsidiaries of that Person or a combination thereof.  For purposes hereof and without limitation, a Person or Persons shall be deemed to have a majority ownership interest in a limited liability company, partnership, association or other business entity (other than a corporation) if such Person or Persons shall be allocated a majority of limited liability company, partnership, association or other business entity gains or losses or shall be or control the manager, managing member, managing director (or a board comprised of any of the foregoing) or general partner of such limited liability company, partnership, association or other business entity.  For purposes hereof, references to a “Subsidiary” of any Person shall be given effect only at such times that such Person has one or more Subsidiaries, and, unless otherwise indicated, the term “Subsidiary” refers to a Subsidiary of the Company.

  “Substituted Unitholder” means a Person that is admitted as a Unitholder to the Company pursuant to Section 10.01.

  9

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  “Supplemental Indemnification Rights” has the meaning set forth in Section 6.04(b).

  “Tag Along Sale” has the meaning set forth in Section 9.02(a).

  “Tag Along Sale Notice” has the meaning set forth in Section 9.02(a).

  “Tax” or “Taxes” means any federal, state, local or foreign income, gross receipts, franchise, estimated, alternative minimum, add on minimum, sales, use, transfer, registration, value added, excise, natural resources, severance, stamp, occupation, premium, windfall profit, environmental, customs, duties, real property, personal property, capital stock, social security, unemployment, disability, payroll, license, employee or other withholding, or other tax, of any kind whatsoever, including any Transferee liability and any interest, penalties or additions to tax or additional amounts in respect of the foregoing.

  [***].

  “Total Equity Value” means, in the case of a Transfer contemplated by Section 9.02 or Section 9.03, the aggregate proceeds to be received by the Unitholders in connection with such Transfer and, otherwise, the aggregate proceeds that would be received by the Unitholders in the case of any Transfer if: (i) the assets of the Company were sold at their Fair Market Value on arm’s length terms, with neither the seller nor the buyer being under compulsion to buy or sell such assets; (ii) the Company satisfied and paid in full all of its then-outstanding obligations and liabilities; and (iii) such net sale proceeds were then distributed in accordance with Section 4.01(a), all as determined by the Board in good faith.

  “Transfer” means any direct or indirect sale, transfer, assignment, pledge, mortgage, exchange, hypothecation, grant of a security interest or other disposition or encumbrance of an interest (whether with or without consideration, whether voluntarily or involuntarily or by operation of law), but excluding conversions of Equity Securities by the Company made in accordance with this Agreement or any merger or consolidation of the Company.  The terms “Transferee,” “Transferor,” “Transferred,” and other forms of the word “Transfer” shall have the correlative meanings.

  “Unit” means a limited liability company interest in the Company of a Unitholder or an Assignee in the Company representing a fractional part of the interests in Profits, Losses and Distributions of the Company held by all Unitholders and Assignees and shall include, without limitation, Common Units; provided that any class, group or series of Units issued shall have the relative rights, powers and obligations set forth in this Agreement.

  “Unitholder” means any owner of one or more Units, including any person admitted to the Company as an Additional Unitholder or Substituted Unitholder, but in each case, only to the extent such Person is shown on the Company’s books and records as the owner of such Units as of the applicable date.  As provided in Section 18-101(7) of the Delaware Act, each Unitholder shall be bound by this Agreement, whether or not such Unitholder shall have executed this Agreement.

  “Unit Ownership Ledger” has the meaning set forth in Section 3.01(b).

  “Unitholder Nonrecourse Debt” shall have the meaning ascribed to the term “Partner Nonrecourse Debts” in Treasury Regulations Section 1.704-2(b)(4).

  “Unitholder Nonrecourse Debt Minimum Gain” has the meaning assigned to the term “partner nonrecourse debt minimum gain” in Treasury Regulation Section 1.704-2(i)(2).

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  “Unitholder Nonrecourse Deductions” shall mean items of Company loss, deduction, or Section 705(a)(2)(B) expenditures which are attributable to Unitholder Nonrecourse Debt.

  ARTICLE II
ORGANIZATIONAL MATTERS

  Section 2.01.	Formation of LLC.  The Company was formed on January 25, 2022 pursuant to the provisions of the Delaware Act. 

  Section 2.02.	Limited Liability Company Agreement. The Unitholders hereby execute this Agreement for the purpose of amending and restating the Prior Agreement and establishing the affairs of the Company and the conduct of its business in accordance with the provisions of the Delaware Act.  The Unitholders hereby agree that during the term of the Company set forth in Section 2.06 the rights, powers and obligations of the Unitholders with respect to the Company will be determined solely in accordance with the terms and conditions of this Agreement and, except where the Delaware Act provides that such rights, powers and obligations specified in the Delaware Act shall apply “unless otherwise provided in a limited liability company agreement” or words of similar effect and such rights, powers and obligations are set forth in this Agreement, the Delaware Act; provided that, notwithstanding the foregoing and anything else to the contrary, Section 18-210 of the Delaware Act (entitled “Contractual Appraisal Rights”) and Section 18-305(a) of the Delaware Act (entitled “Access to and Confidentiality of Information; Records”) shall not apply to or be incorporated into this Agreement and each Unitholder hereby expressly waives any and all rights under such Sections of the Delaware Act.

  Section 2.03.	Name. The name of the Company shall be “Roadrunner Solutions LLC”.  The Board may change the name of the Company at any time and from time to time.  Notification of any such name change shall be given to all Unitholders.  The Company’s business may be conducted under its name and/or any other name or names deemed advisable by the Board.

  Section 2.04.	Purpose. The purpose and business of the Company shall be to manage and direct the business operations and affairs of the Company and its Subsidiaries and to engage in any other lawful acts or activities for which limited liability companies may be organized under the Delaware Act.

  Section 2.05.	Principal Office; Registered Office.  The principal office of the Company shall be located at such place inside or outside the state of Delaware as the Board may from time to time designate,  and all business and activities of the Company shall be deemed to have occurred at its principal office.  The Company may maintain offices at such other place or places as the Board deems advisable.  The address of the registered office of the Company in the State of Delaware shall be the office of the initial registered agent named in the Certificate or such other office (which need not be a place of business of the Company) as the Board may designate from time to time in the manner provided by applicable law, and the registered agent for service of process on the Company in the State of Delaware at such registered office shall be the registered agent named in the Certificate or such Person or Persons as the Board may designate from time to time in the manner provided by applicable law.

  Section 2.06.	Term.  The term of the Company commenced upon the filing of the Certificate in accordance with the Delaware Act and shall continue in existence until the Company shall be terminated and dissolved in accordance with the provisions of ARTICLE XII.

  Section 2.07.	Tax Treatment. The Unitholders intend that the Company be treated as a partnership for U.S. federal and, if applicable, state or local income tax purposes, that the Company shall not take any action (including any entity classification election on IRS Form 8832) to be classified as anything other than a partnership for U.S. federal income tax purposes, and that each Unitholder and the 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  Company shall file all Tax returns and shall otherwise take all Tax and financial reporting positions in a manner consistent with such treatment.

  Section 2.08.	No State-Law Partnership. The Unitholders intend that the Company not be a partnership (including, without limitation, a limited partnership) or joint venture, and that no Unitholder be a partner or joint venturer of any other Unitholder by virtue of this Agreement, for any purposes other than as set forth in Section 2.07, and neither this Agreement nor any other document entered into by the Company or any Unitholder relating to the subject matter hereof shall be construed to suggest otherwise.

  ARTICLE III
UNITS, CAPITAL CONTRIBUTIONS AND CAPITAL ACCOUNTS 

  Section 3.01.	Units.

  (a)	Authorized Units.  Subject to Section 3.02, the total Units which the Company has authority to issue shall be determined by the Board from time to time and shall, as of the Effective Date, be as set forth in the Prior Agreement.  The Company may not issue fractional Units. The ownership by a Unitholder of Units shall entitle such Unitholder to allocations of Profits and Losses and other items and Distributions of cash and other property as set forth in ARTICLE IV hereof. All Units issued hereunder shall be certificated.

  (b)	Unit Ownership Ledger; Capital Contributions.  The Company shall maintain a ledger (the “Unit Ownership Ledger”), which shall be appended to this Agreement as Appendix A, that sets forth the name and address of each Unitholder, the number of each class of Units held of record by each such Unitholder, the amount of the Capital Contribution made with respect to each class of Units and the date of such Capital Contribution, the percentage interest held in the Company by each Unitholder, the issuance date of each Unitholder’s units and the certificate number(s) of each Unitholder’s Units.  Upon any change in the number or ownership of outstanding Units (whether upon an issuance of Units, a Transfer of Units, a cancellation of Units or otherwise), the Company shall amend and update the Unit Ownership Ledger and cancel, issue or reissue any certificates, as applicable, to reflect such corresponding changes in the Unit Ownership Ledger.  Unless otherwise determined by the Board, in an individual case or a general case, the Unit Ownership Ledger will only be provided to Unitholders in summary form.  Absent manifest error, the ownership interests recorded on the Unit Ownership Ledger shall be the conclusive record of the Units that have been issued and are outstanding.  Each Unitholder named in the Unit Ownership Ledger has made (or shall be deemed to have made) Capital Contributions to the Company as set forth in the Unit Ownership Ledger in exchange for the Units specified in the Unit Ownership Ledger.  Any reference in this Agreement to the Unit Ownership Ledger shall be deemed a reference to the Unit Ownership Ledger as amended and in effect from time to time.  No subsequent capital contributions shall be required from any Unitholder.

  Section 3.02.	Issuance of Additional Units and Interests.  Subject to Section 3.03, Section 5.03(b) and Section 5.03(c), the Board shall have the right at any time and from time to time to cause the Company to create and/or issue Equity Securities (including other classes, groups or series thereof having such relative rights, powers, and/or obligations as may from time to time be established by the Board, including rights, powers, and/or obligations different from, senior to or more favorable than existing classes, groups and series of Equity Securities), in which event, (a) all Unitholders holding the same class of Units shall be diluted in an equal manner with respect to such issuance with respect to such same class of Units (it being understood that different classes of Units may be treated differently) and (b) the Board, shall have the power to amend this Agreement and/or the Unit Ownership Ledger to reflect such additional issuances and dilution and to make any such other amendments as it deems necessary or desirable (in its sole discretion) to reflect such additional issuances (including, without limitation, authorizing an increase in the 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  authorized number of Equity Securities of any class, group or series, amending this Agreement to create and authorize a new class, group or series of Equity Securities and to add the terms of such new class, group or series of Equity Securities, including economic and governance rights which may be different from, senior to or more favorable than the other existing Equity Securities), in each case, without the approval or consent of any other Person.  In connection with any issuance of Units (whether on or after the date hereof), the Person who acquires such Units shall execute a joinder or counterpart to this Agreement accepting and agreeing to be bound by all terms and conditions hereof, and shall enter into such other documents, instruments and agreements to effect such purchase as are required by the Board.  Each Person who acquires Units shall, in exchange for such Units, make a Capital Contribution to the Company in an amount to be determined by the Board in its sole discretion.

  Section 3.03.	Preemptive Rights.

  (a)	Except for Excluded Issuances, following the date hereof, if the Company offers to sell or grant the right to purchase any Equity Securities or debt securities (referred to collectively for the purposes of this Section 3.03 as the “Offeree Investors”), the Company shall offer to sell to each other Unitholder holding Common Units a portion of such securities equal to (x) the number of Equity Securities of the Company or its Subsidiaries being sold multiplied by (y) a fraction, the numerator of which is the total number of Common Units held by such Unitholder and the denominator of which is the total number of Common Units outstanding.  Each Unitholder having rights pursuant to this Section 3.03 shall be entitled to purchase the offered securities at the most favorable price as such securities are to be offered to any Offeree Investor; provided that if any Offeree Investor is required to also purchase other securities or debt of the Company or any of its Subsidiaries, the Unitholder(s) exercising their rights pursuant to this Section 3.03 shall also be required to purchase their Pro Rata Share of the same strip of securities (on the same terms and conditions) that such Offeree Investor is required to purchase.  The purchase price for all securities purchased under this Section 3.03 shall be payable in cash.

  (b)	In order to exercise its purchase rights hereunder, a Unitholder having preemptive rights pursuant to this Section 3.03 must, within 10 calendar days after delivery to such Unitholder of written notice in accordance with Section 14.09 (a “Preemptive Rights Notice”) from the Company describing in reasonable detail (i) the securities being offered, (ii) the purchase price thereof, (iii) the payment terms and (iv) the amount such Person is eligible to purchase hereunder, deliver a written notice to the Company irrevocably exercising such Unitholder’s purchase rights pursuant to this Section 3.03.

  (c)	Upon the expiration of the offering periods described above, the Company shall be entitled to sell such securities which such Unitholders having rights pursuant to this Section 3.03 have not elected to purchase during the 90 calendar days following such expiration at a price not less than the price set forth in the Preemptive Rights Notice.  Any securities offered or sold by the Company after such 90 day period must be reoffered pursuant to the terms of this Section 3.03 to the extent this Section 3.03 applies to such offering.

  (d)	Each Unitholder exercising its purchase rights hereunder shall take all reasonably necessary and desirable actions as directed by the Company in connection with such Person’s participation in the applicable issuance, including executing a purchase (or similar) agreement and making representations and warranties therein and agreeing to provide indemnification as directed by the Company.

  Section 3.04.	Capital Accounts.  

  (a)	There shall be established on the books and records of the Company a Capital Account for each Unitholder.

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  (b)	The Board shall cause the Unitholders’ Capital Accounts to be adjusted and maintained in accordance with the principles of Section 704(b) of the Code and the Treasury Regulations thereunder.  Without limiting the foregoing, the balance in each Unitholder’s Capital Account shall be adjusted by (i) increasing such balance by (A) such Unitholder’s allocable share of each item of the Company’s Profits (allocated in accordance with Section 3.05 and Section 3.06) and (B) the Capital Contributions, if any, made by such Unitholder; and (ii) decreasing such balance by (A) the amount of cash or the value of other property distributed to such Unitholder pursuant to this Agreement (net of liabilities secured by the distributed property that such Unitholder is considered to assume or take subject to under Section 752 of the Code) and (B) such Unitholder’s allocable share of each item of the Company’s Losses allocated in accordance with Section 3.05 and Section 3.06).

  (c)	Except as provided in this Agreement or required by law, no Unitholder shall be required to make up a negative balance in such Unitholder’s Capital Account.

  Section 3.05.	Allocations of Profits and Losses.  

  (a)	Subject to the special allocations provided in Section 3.05(b), Profits and Losses (and, to the extent necessary, items of income, gain, loss and deduction) for each Allocation Period shall be allocated among the Unitholders with respect to each such Allocation Period to equal, as nearly as possible, (i) the amount such Unitholders would receive if all assets of the Company on hand at the end of such Allocation Period were sold for cash equal to their Book Values, all liabilities of the Company were satisfied in cash in accordance with their terms (limited in the case of non-recourse liabilities to the Book Value of the property securing such liabilities), and all remaining or resulting cash (including any withheld amounts) were distributed to the Unitholders under Section 12.02(c)) minus (ii) such Unitholder’s share of Company Minimum Gain and Unitholder Nonrecourse Debt Minimum Gain, computed immediately prior to the hypothetical sale of assets, and the amount any such Unitholder is treated as obligated to contribute to the Company, computed immediately after the hypothetical sale of assets.

  (b)	Special Allocations. Notwithstanding any other provision in this Section 3.05, the following special allocations shall be made in the following order:

  (i)	Minimum Gain Chargeback.  If there is a net decrease in Company Minimum Gain during any Allocation Period, each Unitholder shall be specially allocated items of Company income and gain for such Allocation Period (and, if necessary, in subsequent Allocation Periods) in an amount equal to the portion of such Unitholder’s share of the net decrease in Company Minimum Gain that is allocable to the disposition of Company property subject to a Nonrecourse Liability, which share of such net decrease shall be determined in accordance with Treasury Regulations Section 1.704-2(g)(2).  The items to be so allocated shall be determined in accordance with Treasury Regulations Section 1.704-2(f).  This Section 3.05(b)(i) is intended to comply with the minimum gain chargeback requirement contained in Treasury Regulations Section 1.704-2(f) and shall be interpreted consistent therewith.

  (ii)	Chargeback of Minimum Gain Attributable to Unitholder Nonrecourse Debt.  If there is a net decrease in unitholder Nonrecourse Debt Minimum Gain attributable to any Unitholder Nonrecourse Debt during any Allocation Period, each Unitholder who has a share of the Unitholder Nonrecourse Debt Minimum Gain (which share shall be determined in accordance with Treasury Regulations Section 1.704-2(i)(5)) shall be specially allocated items of Company income and gain for such Allocation Period (and, if necessary, in subsequent Allocation Periods) in an amount equal to that portion of such Unitholder’s share of the net decrease in Unitholder Nonrecourse Debt Minimum Gain that is allocable to the disposition of Company property subject to such Unitholder Nonrecourse Debt (which share of such net decrease shall be determined in accordance with Treasury Regulations Section 1.704-2(i)(5)).  The items to be so allocated shall be determined in accordance with Treasury Regulations Section 

  14

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.704-2(i)(4).  This Section 3.05(b)(ii) is intended to comply with the minimum gain chargeback requirement contained in Treasury Regulations Section 1.704-2(i)(4) and shall be interpreted consistent therewith.

  (iii)	Nonrecourse Deductions. Any nonrecourse deductions (as defined in Treasury Regulations Section 1.704-2(b)(1)) for any Allocation Period shall be specially allocated to the Unitholders in proportion to their percentage interests.

  (iv)	Unitholder Nonrecourse Deductions.  Those items of Company loss, deduction, or expenditures pursuant to Section 705(a)(2)(B) of the Code that are attributable to Unitholder Nonrecourse Debt for any Allocation Period shall be specially allocated to the Unitholder that bears the economic risk of loss with respect to the Unitholder Nonrecourse Debt to which such items are attributable in accordance with Treasury Regulations Section 1.704-2(i).

  (v)	Qualified Income Offset.  If a Unitholder unexpectedly receives any adjustments, allocations, or Distributions described in Treasury Regulations Section 1.704-l(b)(2)(ii)(d)(4), (5) or (6), or any other event creates a deficit balance in such Unitholder’s Capital Account in excess of such Unitholder’s share of Company Minimum Gain, items of Company income and gain shall be specially allocated to such Unitholder in an amount and manner sufficient to eliminate such excess deficit balance as quickly as possible. This Section 3.05(b)(v) is intended to qualify and be construed as a “qualified income offset” within the meaning of Treasury Regulation Section 1.704-1(b)(2)(ii)(d) and shall be interpreted consistently therewith.

  (vi)	If there is a change in the percentage interest of the Unitholders as a result of Capital Contributions pursuant to Section 3.01(b), any gain or loss resulting from the adjustment of the Book Value of any Company asset in connection with such capital contribution shall be allocated among the Unitholders so as to cause (to the nearest extent possible) the Capital Account of the Unitholders (as calculated after taking into account any adjustments to the Percentage Interests and such capital contributions) to be in proportion to (A) the amount each Unitholder would receive if all assets of the Company on hand at the end of such Allocation Period were sold for cash equal to their Book Values, all liabilities of the Company were satisfied in cash in accordance with their terms (limited in the case of non-recourse liabilities to the Book Value of the property securing such liabilities), and all remaining or resulting cash (including any withheld amounts) were distributed to the Unitholders under Section 12.02(c) minus (B) such Unitholder’s share of Company Minimum Gain and Unitholder Nonrecourse Debt Minimum Gain, computed immediately prior to the hypothetical sale of assets, and the amount any such Unitholder is treated as obligated to contribute to the Company, computed immediately after the hypothetical sale of assets.

  (vii)	Any special allocations of items of income and gain pursuant to this Section 3.05 shall be taken into account in computing subsequent allocations of income and gain pursuant to this ARTICLE III so that the net amount of any item so allocated and the income, gain, and losses allocated to each Unitholder pursuant to this ARTICLE III to the extent possible, shall be equal to the net amount that would have been allocated to each such Unitholder as if the special allocations pursuant to this Section 3.05 had not occurred.

  Section 3.06.	Income Tax Allocations.  

  (a)	Except as provided in this Section 3.06, each item of income, gain, loss and deduction of the Company for federal income tax purposes shall be allocated, to the maximum extent possible, among the Unitholders in the same manner as the corresponding items (if any) are allocated for purposes of maintaining Capital Accounts under Section 3.05.

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  (b)	The Unitholders recognize that there may be a difference between the Book Value of a Company asset and the asset’s adjusted tax basis at the time of the property’s contribution or revaluation pursuant to this Agreement. In such a case, all items of tax depreciation, cost recovery, amortization, and gain or loss with respect to such asset shall be allocated among the Unitholders to take into account the disparities between the Book Values and the adjusted tax basis with respect to such properties in accordance with the “remedial” method under Sections 704(b) and 704(c) of the Code.  

  (c)	All items of income, gain, loss, deduction and credit allocated to the Unitholders in accordance with the provisions hereof shall be determined without regard to any election under Section 754 of the Code which may be made by the Company; provided, however, that such allocations, once made, shall be adjusted as necessary or appropriate to take into account the adjustments permitted by Sections 734 and 743 of the Code.

  (d)	If any deductions for depreciation, amortization or cost recovery are recaptured as ordinary income upon the sale or other disposition of Company properties, the ordinary income character of the gain from such sale or disposition shall be allocated among the Unitholders in the same ratio as the deductions giving rise to such ordinary income character were allocated in accordance with Treasury Regulations Section 1.1245-1.

  (e)	The Unitholders’ proportionate shares of the “excess nonrecourse liabilities” of the Company, within the meaning of Treasury Regulation Section 1.752-3(a)(3), shall be allocated to the holders of Units in accordance with their respective percentage interests.

  (f)	Tax credits of the Company shall be allocated among the Unitholders as provided in Treasury Regulation Sections 1.704-1(b)(4)(ii) and 1.704-1(b)(4)(viii).

  (g)	Allocations pursuant to this Section 3.06 are solely for purposes of federal, state, and local taxes and except as specifically provided shall not affect, or in any way be taken into account in computing, any Unitholder’s Capital Account or share of Profits, Losses, other items or Distributions pursuant to any provision of this Agreement.

  ARTICLE IV
DISTRIBUTIONS

  Section 4.01.	Distributions.

  (a)	Distribution Priorities.  Except as otherwise set forth in this ARTICLE IV, and subject to the provisions of Section 18-607 of the Delaware Act, the Board may in its discretion make Distributions at any time or from time to time.  All Distributions shall be made to the Unitholders of Common Units (ratably among such holders based upon the number of Common Units held immediately prior to such Distribution);

  (b)	The Board may apply Section 4.01(a) by breaking a single Distribution into two or more Distributions treated as separate Distributions occurring in order.

  (c)	Reserves Against Distributions.  The Board shall have the right to (i) withhold from Distributions payable to any Unitholder under this Agreement an amount sufficient to pay and discharge such Unitholder’s indirect Pro Rata Share of any contingent liabilities of the Company or any of its Subsidiaries and/or (ii) condition any Distributions payable to any Unitholder under this Agreement on such Unitholder agreeing to return to the Company, on demand, an amount sufficient to pay and discharge such Unitholder’s indirect Pro Rata Share of any contingent liabilities of the Company or any of its Subsidiaries.  

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  Any amounts remaining after payment and discharge of any such contingent liabilities of the Company or any of its Subsidiaries will be paid to the Unitholders from whom the Distributions were withheld.

  Section 4.02.	Tax Distributions.  Notwithstanding Section 4.01, the Company shall make a Distribution to each Unitholder to the extent of Available Cash no later than five (5) days prior to the U.S. federal estimated income tax payment dates applicable to corporations (and, if necessary, no later than 30 days after the end of the Fiscal Year) in an amount equal to the excess (if any) of (a) the product of the Assumed Tax Rate and all taxable income and gain allocable to such Unitholder pursuant to this Agreement (including, for the avoidance of doubt, any income allocable as a result of Section 704(c) of the Code) for the applicable quarterly estimated tax period or Fiscal Year and (b) the aggregate amounts previously distributed to such Unitholder pursuant to Section 4.01 and this Section 4.02 with respect to such Fiscal Year. Any amount distributed to a Unitholder pursuant to this Section 4.02 shall be deemed to be an advance Distribution of amounts otherwise distributable to such Unitholder pursuant to Section 4.01 and shall reduce the amounts that would subsequently otherwise be distributable to such Unitholder pursuant to Section 4.01 in the order in which such amounts would otherwise have been distributable.

  Section 4.03.	Withholding. Notwithstanding any contrary provision of this Agreement, the Company shall be permitted to withhold and deduct any amounts required by applicable law to be withheld or deducted with respect to any Unitholder.  The Company shall timely remit any amounts so withheld or deducted to the appropriate taxing authority.  If and to the extent that the Company is required to withhold or pay any such withholding or other taxes on behalf of, or with respect to, a Unitholder, such Unitholder shall be deemed for all purposes of this Agreement to have received a payment from the Company as of the time that such withholding or other tax is required to be paid, which payment shall be deemed to be a Distribution with respect to such Unitholder’s interest in the Company to the extent that such Unitholder (or any successor to such Unitholder’s interest in the Company) would have received a cash Distribution but for such withholding.  To the extent that such payment exceeds the cash Distribution that such Unitholder would have received but for such withholding, the Board shall notify such Unitholder as to the amount of such excess, and such Unitholder shall make a prompt payment to the Company of such amount, which payment will not constitute a Capital Contribution.  Each Unitholder and the Company shall use commercially reasonable efforts to reduce or eliminate the amount required to be withheld or deducted with respect to such Unitholder. The obligations of a Unitholder pursuant to this Section 4.03 shall survive the termination, dissolution, liquidation and winding up of the Company and the withdrawal of such Unitholder from the Company or transfer of its interests.

  ARTICLE V
GOVERNANCE

  Section 5.01.	Authority.

  (a)	Authority of Board.  Pursuant to Section 18-402 of the Delaware Act and subject in all respects to the limitations set forth in Section 5.03, as provided in this Section 5.01, (i) the Board shall conduct, direct and exercise full control over all activities of the Company (including all decisions relating to the issuance of additional Equity Securities, and the voting and sale of, and the exercise of other rights with respect to, the equity securities of its Subsidiaries), (ii) all management powers over the business and affairs of the Company shall be exclusively vested in the Board and (iii) the Board shall have the sole power to bind or take any action on behalf of the Company, or to exercise any rights and powers (including the rights and powers to take certain actions, give or withhold certain consents or approvals, or make certain determinations, opinions, judgments, or other decisions) granted to the Company under this Agreement or any other agreement, instrument, or other document to which the Company is a party.

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  (b)	Certain Actions.  Without limiting the generality of the foregoing, but subject in all respects to the limitations set forth in Section 5.03, (i) the Board shall exercise all rights and powers of the Company and/or its Subsidiaries (including all rights and powers to take actions, give or withhold consents or approvals, waive or require the satisfaction of conditions, or make determinations, opinions, judgments, or other decisions, and whether such rights and powers are granted to the Company under the terms of an agreement to which the Company is a party, or arise as a result of the Company’s direct or indirect ownership of securities or otherwise) which are granted to the Company and/or its Subsidiaries under the Purchase Agreement and the agreements, instruments or documents contemplated respectively thereby; and (ii) subject only to the terms and conditions of Section 3.02, the Board may determine the timing and amount and other terms of any equity investment in the Company and may effect amendments to this Agreement necessary in order to effectuate such equity investments, in each case without any vote or other approval by the Unitholders.

  Section 5.02.	Composition of the Board.

  (a)	Number and Appointment.  The number of Directors on the Board and the appointment rights in respect thereof shall be determined pursuant to this Section 5.02(a) (and subject to Section 5.03, as applicable), and the Board shall be comprised of the following Persons:

  (i)	three Directors as designated by OXB from time to time (the “OXB Directors”);

  (ii)	one Director designated by HMI from time to time (the “HMI Director”); and

  (iii)	the chief executive officer of the Company (the “CEO”), so long as (and only so long as) such person remains the chief executive officer of the Company.

  (b)	Term.  Each Director shall serve until a successor is appointed in accordance with the terms hereof or his or her earlier resignation, death or removal.  A person shall become a Director effective upon receipt by the Company of written notice (or at such later time or upon the happening of some other event specified in such notice) of such person’s designation by the Person or Persons entitled to designate such Director pursuant to Section 5.02(a) above; provided that the persons identified in Section 5.02(a) above, if any, by name shall become Directors effective upon the date hereof.  A Director may resign at any time by delivering written notice to the Company.  Such resignation shall be effective upon receipt unless it is specified to be effective at some other time or upon the happening of some other event.

  (c)	Removal.  If a CEO ceases to be the chief executive officer of the Company for any reason, such CEO shall be removed automatically from the Board and each committee thereof upon such cessation (without any action on the part of such CEO, the Board or such committees).  The removal from the Board or any of its committees (with or without cause) of any OXB Director shall be upon (and only upon) the written request of OXB.  The removal from the Board or any of its committees (with or without cause) of any HMI Director shall be upon (and only upon) the written request of HMI.

  (d)	Vacancies.  A vacancy on the Board because of resignation, death or removal of a Director will be filled by the Person or Persons entitled to appoint such Director pursuant to the terms of Section 5.02(a) above.  If any Person or Persons fail to appoint a Director pursuant to the terms of Section 5.02(a) above or the immediately preceding sentence, such position on the Board shall remain vacant until such Person or Persons exercise their right to appoint a Director as provided hereunder.

  (e)	Reimbursement.  The Company shall pay, or shall cause one of its Subsidiaries to pay, the out-of-pocket costs and expenses incurred by each Director in the course of his or her service to the Company and/or its Subsidiaries, including in connection with attending regular and special meetings 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  of the Board, any board of managers or board of directors of each of the Company’s Subsidiaries and/or any of their respective committees.

  (f)	Compensation of Directors.  Except for reimbursement of reasonable out-of-pocket costs and expenses, OXB Directors, the HMI Director and the CEO shall not be compensated for their services as Directors.

  (g)	Sub Boards; Committees.  The composition of the board of directors or board of managers of any Subsidiary of the Company shall be identical to the composition of the Board, unless otherwise approved by the Board (including the HMI Director).  The voting rights on the board of directors or board of managers of each of the Company’s Subsidiaries of the Directors serving on any such boards shall be commensurate with the voting rights of the Directors with respect to the Board.  The composition of any committee of the Board shall be determined by the Board, but shall include the HMI Director.

  Section 5.03.	Board Actions; Meetings.

  (a)	Quorum; Voting.  All OXB Directors and the HMI Director must be present at any meeting of the Board or any committee thereof (including for purposes of actions taken pursuant to Section 5.03(e)) in order to constitute a quorum for the transaction of business of the Board or such committee; provided, that if the HMI Director is not present at a duly called meeting of the Board, such meeting may be adjourned and reconvened with not less than 48 hours’ notice and the HMI Director’s presence shall not be necessary for a quorum at such reconvened meeting. Except as otherwise provided in this Agreement, the act of the Directors that have a majority of the total votes present at a meeting of the Board or such committee at which a quorum is present shall be the act of the Board or such committee.  Notwithstanding the foregoing, once a quorum is present to commence a meeting of the Board or any committee thereof, such quorum shall be broken as soon as any OXB Director is no longer present at such meeting and no further business may be transacted at such meeting until such time as a quorum shall again be present. If a quorum shall not be present during a meeting of the Board or any committee thereof, the Directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present.  Each Director shall have one vote on all matters voted on by the Board or any committee thereof of which such Director is a member.

  (b)	Matters Requiring Consent of the OXB Directors.  So long as OXB holds a majority of the Units, the Company will not, and will cause its Subsidiaries not to, without approval of the Board, which must include the approval of the OXB Directors: 

  (i)	amend the certificate of formation or this Agreement; 

  (ii)	waive, or consent to the waiver by the Company of, any rights under this Agreement; 

  (iii)	make any material change to the nature of the Business or change the principal place of business of the Company; 

  (iv)	file any applications for, or materially modify, any material permit; 

  (v)	issue, purchase or redeem any Equity Securities, admit any additional Unitholders, accept any additional Capital Contribution or grant any equity or equity-linked securities; 

  (vi)	divide the Units into series or classes; 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  (vii)	approve the Budget for any Fiscal Year or any amendment thereto; 

  (viii)	authorize Distributions (other than Tax Distributions); 

  (ix)	establish any reserves on the Company’s balance sheet (other than ordinary course reserves established in accordance with GAAP); 

  (x)	incur any indebtedness for borrowed money, pledge or grant liens on any assets, or guarantee, assume, endorse or otherwise become responsible for the obligations of any other person, in each case in excess of $100,000; 

  (xi)	make any loan, advance, capital contribution or other investment in or to any person in excess of $100,000; 

  (xii)	enter into any transaction or series of related transactions involving the purchase, lease, license, exchange or other acquisition (including by merger, consolidation, acquisition of stock or acquisition of assets) of any assets and/or equity interests of any person, other than in the ordinary course of business; 

  (xiii)	enter into or effect any transaction involving the sale, lease, license, exchange or other disposition (including by merger, consolidation, sale of stock or sale of assets) of any assets in excess of $100,000; 

  (xiv)	approve any merger, consolidation or combination with or into any other person including any Sale of the Company; 

  (xv)	establish a Subsidiary or enter into any joint venture or similar business arrangement; 

  (xvi)	settle any lawsuit, action, dispute or other proceeding or assume any liability in excess of a certain amount; 

  (xvii)	initiate or consummate an initial public offering or make a public offering and sale of any Units or any other securities of the Company or any successor entity; 

  (xviii)	appoint or remove the Company’s auditors or make any changes in the accounting methods or policies of the Company (other than as required by GAAP); 

  (xix)	enter into, amend, waive, supplement or terminate any agreement between the Company or any of its Subsidiaries, on the one hand, and HMI or its controlled Affiliates, on the other hand; 

  (xx)	initiate a bankruptcy proceeding (or consent to any involuntary bankruptcy proceeding); 

  (xxi)	(1) hire or terminate the CEO or any other officer with the title of “Head of Department” or more senior, (2) change any compensation policies applicable to any such officer, or (3) enter into any material agreement with respect to such officer’s employment, severance, consultancy or other service to the Company;

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  (xxii)	hire any employees other than in accordance with the Budget, or as approved by the Board from time to time;

  (xxiii)	adopt any equity incentive plan; 

  (xxiv)	establish, dissolve, modify in any material respect the role or authority of, or change the composition of, a board committee; 

  (xxv)	approve any investment policy of the Company;

  (xxvi)	establish the corporate strategy of the Company, including with respect to the technological direction of the Business; 

  (xxvii)	sell or exclusively out-license any material technology or intellectual property assets, other than licenses in the ordinary course of business; 

  (xxviii)	voluntarily liquidate, wind up or dissolve the Company or initiate a bankruptcy proceeding (or consent to any involuntary bankruptcy proceeding);

  (xxix)	sell, transfer, license, pledge or encumber technology or intellectual property, other than licenses granted in the ordinary course of business and ordinary course disposal or replacement of obsolete technology or unused intellectual property; or 

  (xxx)	make any commitment or enter into any binding agreement with respect to any of the foregoing matters.

  (c)	Matters Requiring Consent of the HMI Director.  So long as HMI holds Units, the Company will not, and will cause its Subsidiaries not to, without approval of the Board, which must include the approval of the HMI Director:  

  (i)	make any material change to the nature of the Business or change the principal place of business of the Company; 

  (ii)	authorize Distributions on (other than Tax Distributions), or redeem or repurchase, any Equity Securities of the Company, in each case, on a non-Pro Rata Basis for the same class of Units; 

  (iii)	approve or effect any Sale of the Company; provided that, for the avoidance of doubt, a change of control of OXB will not require the approval of the Board or the HMI Director; 

  (iv)	enter into any transaction or series of related transactions involving the purchase, lease, license, exchange or other acquisition (including by merger, consolidation, acquisition of stock or acquisition of assets) of any assets and/or equity interests of any person, in each case having a value in excess of $5,000,000, other than in the ordinary course of business;

  (v)	voluntarily liquidate, wind up or dissolve the Company or initiate a bankruptcy proceeding (or consent to any involuntary bankruptcy proceeding); 

  (vi)	take any action that would result in a change in the tax status of the Company; 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  (vii)	amend, alter or repeal HMI’s rights set forth in this Agreement in a manner that adversely affects HMI’s rights hereunder; 

  (viii)	enter into a non-arms-length transaction with OXB or any of its Affiliates; provided that, without limiting and in all respects subject to the provisions set forth in Section 6.06, Board approval shall not be required in connection with the Company licensing intellectual property, know-how, trade secrets or materials, or providing other information and technology to OXB, or as otherwise set forth in any of the transaction documents; 

  (ix)	other than Excluded Issuances and issuances in connection with any working capital-related financings, issue any Equity Securities; or

  (x)	enter into arrangements that restrict HMI from exercising the foregoing consent rights or contain restrictive covenants binding, limiting or restricting HMI or its affiliates (other than the Company).

  Notwithstanding the foregoing, following the three-year anniversary of the Closing Date, clauses (i), (iii), (iv), (v), (ix) and, solely as it relates to the foregoing clauses following the three-year anniversary of the Closing Date, clause (x), of this Section 5.03(c) shall no longer apply.

  (d)	Meetings.  Meetings of the Board and any committee thereof shall be held at the principal office of the Company or at such other place as may be determined by the Board or such committee.  Regular meetings of the Board shall be held on such dates and at such times and places as shall be determined by the Board.  Special meetings of the Board may be called by the chairman or any OXB Director or the HMI Director, and special meetings of any committee may be called by the chairman or any OXB Director on such committee.  Notice of each special meeting of the Board or committee stating the date, place and time of such meeting shall be given to each Director (in the case of a Board meeting) or each Director on such committee (in the case of a committee meeting) by hand, telephone, electronic mail, overnight courier or the U.S. mail at least two (2) Business Days prior to such meeting.  Notice may be waived before or after a meeting or by attendance without protest at such meeting.

  (e)	Action by Written Consent or Telephone Conference.  Any action permitted or required by the Delaware Act, the Certificate or this Agreement to be taken at a meeting of the Board or any committee designated by the Board may be taken without a meeting, without notice and without a vote if a consent in writing, setting forth the action to be taken, is signed by all of the Directors (or all of the Directors comprising such committee).  Such consent shall have the same force and effect as a vote at a meeting and may be stated as such in any document or instrument filed with the Secretary of State of Delaware, and the execution of such consent shall constitute attendance or presence in person at a meeting of the Board or any such committee, as the case may be.  Subject to the requirements of the Delaware Act, the Certificate or this Agreement for notice of meetings, unless otherwise restricted by the Certificate, the Directors or members of any committee designated by the Board may participate in and hold a meeting of the Board or any committee, as the case may be, by means of a conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and participation in such meeting shall constitute attendance and presence in person at such meeting, except where a person participates in the meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting is not lawfully called or convened.

  Section 5.04.	Delegation of Authority.  Without limiting and subject in all respects to Section 5.03(b) and Section 5.03(c), the Board may, from time to time, delegate to one or more Persons (including any Unitholder or Officer and including through the creation and establishment of one or more other committees) such authority and duties as the Board may deem advisable.  Any delegation pursuant to this 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  Section 5.04 may be revoked at any time by the Board.  The members (and observers) of any committee of the Board shall be determined by the Board in its discretion in accordance with the requirements in Section 5.02(g).

  Section 5.05.	Purchase of Units.  Subject to the Company’s compliance with the other applicable provisions of this Agreement, the Board may cause the Company to purchase, repurchase or otherwise acquire Units on a Pro Rata Basis (as applicable); provided that this provision shall not in and of itself obligate any Unitholder to sell any Units to the Company.  So long as any such Units are owned by the Company, such Units will not be considered outstanding for any purpose and shall be deemed cancelled upon the acquisition thereof by the Company.

  Section 5.06.	Officers.

  (a)	Designation and Appointment.  The Board may (but need not), from time to time, designate and appoint one or more persons as an Officer of the Company.  No Officer need be a resident of the State of Delaware, a Unitholder or a Director.  Any Officers so designated shall have such authority and perform such duties as the Board may, from time to time, delegate to them.  The Board may assign titles to particular Officers (including, without limitation, Executive Chairman, Chairman, Chief Executive Officer, President, Chief Financial Officer, Chief Operating Officer, Vice President, Executive Vice President, Secretary, Assistant Secretary, Treasurer, or Assistant Treasurer).  Unless the Board otherwise decides, if the title is one commonly used for officers of a business corporation formed, the assignment of such title shall constitute the delegation to such Officer of the authority and duties that are normally associated with that office, subject to (i) any specific delegation of authority and duties made to such Officer by the Board pursuant to the third sentence of this Section 5.06(a) and (ii) any delegation of authority and duties made to one or more Officers pursuant to the terms of Section 5.04.  Each Officer shall hold office until such Officer’s successor shall be duly designated or until such Officer’s death or until such Officer shall resign or shall have been removed in the manner hereinafter provided.  Any number of offices may be held by the same individual.  The salaries or other compensation, if any, of the Officers and agents of the Company shall be fixed from time to time by the Board.

  (b)	Resignation; Removal; Vacancies.  Any Officer (subject to any contract rights available to the Company, if applicable) may resign as such at any time.  Such resignation shall be made in writing and shall take effect at the time specified therein, or if no time be specified, at the time of its receipt by the Board.  The acceptance of a resignation shall not be necessary to make it effective, unless expressly so provided in the resignation.  Any Officer may be removed as such, either with or without cause, by the Board in its discretion at any time; provided, however, that such removal shall be without prejudice to the contract rights, if any, of the individual so removed.  Designation of an Officer shall not of itself create contract rights.  Any vacancy occurring in any office of the Company may be filled by the Board and shall remain vacant until filled by the Board.

  (c)	Duties of Officers; Generally.  The Officers, in the performance of their duties as such, shall owe to the Company and the Unitholders duties of loyalty and due care of the type owed by the officers of a corporation to such corporation and its stockholders under the laws of the State of Delaware.

  Section 5.07.	Limitations.

  (a)	Waiver of Fiduciary Duties.  The Unitholders expressly acknowledge and agree hereby that their relationship to the Company, the Board and each other is strictly contractual in nature and is not that of partners, joint venturers or any similarly situated persons and is not fiduciary in nature. This Agreement is not intended to, and does not, create or impose any fiduciary duty or liability on any Covered Person. To the extent that, at law or in equity, a Covered Person has duties (including fiduciary duties) and 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  liabilities relating to such Covered Person to the Company or to any other Person, a Covered Person acting under this Agreement shall not be liable to the Company or to any other Person for its good faith reliance on the provisions of this Agreement.  The Unitholders hereby acknowledge and agree that the provisions of this Agreement, to the extent that they restrict the duties and liabilities of a Covered Person otherwise existing at law or in equity, will replace such other duties and liabilities of such Covered Person.  No Unitholder shall take, or cause or permit its Affiliates, directors, managers, members, partners, officers, employees or agents to take, any action that would bind or obligate the Company in any manner not expressly authorized by this Agreement. 

  (b)	Board Discretion.  Whenever in this Agreement or any other agreement contemplated herein or to which the Company is a party the Board (or any committee thereof) is permitted or required to take any action or to make a decision or determination, the Board (or such committee) shall take such action or make such decision or determination in its sole discretion, unless another standard is expressly set forth herein or therein.  Whenever in this Agreement or any other agreement contemplated herein the Board (or any committee thereof) is permitted or required to take any action or to make a decision or determination in its “sole discretion” or “discretion,” with “complete discretion” or under a grant of similar authority or latitude, each Director shall be entitled to consider such interests and factors as such Director desires. 

  (c)	Good Faith and Other Standards.  Whenever in this Agreement or any other agreement contemplated herein or to which the Company is a party the Board (or any committee thereof) is permitted or required to take any action or to make a decision or determination in its “good faith” or under another express standard, each Director shall act under such express standard and, to the extent permitted by applicable law, shall not be subject to any other or different standards imposed by this Agreement or any other agreement contemplated herein or to which the Company is a party.  

  ARTICLE VI
RIGHTS AND OBLIGATIONS OF UNITHOLDERS

  Section 6.01.	Limitation of Liability.  Except as otherwise provided by non-waivable provisions of the Delaware Act, the debts, obligations and liabilities of the Company, whether arising in contract, tort or otherwise, shall be solely the debts, obligations and liabilities of the Company, and no Covered Person shall be obligated personally for any such debt, obligation or liability of the Company solely by reason of being a Unitholder or acting as a Director of the Company.  Except as otherwise provided in this Agreement, a Unitholder’s liability (in its capacity as such) for debts, liabilities and losses of the Company shall be such Unitholder’s share of the Company’s assets; provided that a Unitholder shall be required to return to the Company any Distribution made to it (a) in clear and manifest accounting or similar error or (b) in clear, manifest and material breach of this Agreement, in each case, with respect to which written notice thereof has been delivered to the applicable Unitholder(s) within 60 days after the applicable Distribution.  The immediately preceding sentence shall constitute a compromise to which all Unitholders have consented within the meaning of the Delaware Act.  Notwithstanding anything contained herein to the contrary, the failure of the Company to observe any formalities or requirements relating to the exercise of its powers or management of its business and affairs under this Agreement or the Delaware Act shall not be grounds for imposing personal liability on the Covered Person for liabilities of the Company.  Any amendment, modification or repeal of this Section 6.01 shall be prospective only and shall not in any way affect the limitations on the liability of the Unitholders under this Section 6.01 as in effect immediately prior to such amendment, modification or repeal with respect to claims arising from or relating to matters occurring, in whole or in part, prior to such amendment, modification or repeal, regardless of when such claims may arise or be asserted, and provided such Person became a Unitholder hereunder prior to such amendment, modification or repeal. 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  Section 6.02.	Lack of Authority.  Except as expressly set forth herein, no Unitholder in its capacity as such has the authority or power to act for or on behalf of the Company in any manner or way, to bind the Company, or do any act that would be (or could be construed as) binding on the Company, in any manner or way, or to make any expenditures on behalf of the Company, unless such specific authority and power has been expressly granted to and not revoked from such Unitholder by the Board or pursuant to this Agreement (including pursuant to Section 5.03(b) or Section 5.03(c)), and the Unitholders hereby consent to the good faith exercise by the Board of the powers conferred on it by law and this Agreement.

  Section 6.03.	No Right of Partition.  No Unitholder shall have the right to seek or obtain partition by court decree or operation of law of any Company property, or the right to own or use particular or individual assets of the Company.

  Section 6.04.	Indemnification.

  (a)	Generally.  The Company hereby agrees to indemnify and hold harmless any Covered Person (each an “Indemnified Person”) to the fullest extent permitted under the Delaware Act, as the same now exists or may hereafter be amended, substituted or replaced (but, in the case of any such amendment, substitution or replacement only to the extent that such amendment, substitution or replacement permits the Company to provide broader indemnification rights than the Company is providing immediately prior to such amendment, substitution or replacement), against all expenses, liabilities and losses whatsoever (including attorney fees and expenses, judgments, fines, excise Taxes or penalties) incurred or suffered by such Person (or one or more of such Person’s Affiliates) by reason of the fact that such Person is or was a controlling Affiliate of the Company, or is or was serving as a Director, officer or director of the Company or is or was serving at the request of the Company as a managing member, manager, officer or director of another corporation, partnership, joint venture, limited liability company, trust or other enterprise or is or was a controlling Unitholder of the Company; provided that, unless the Board otherwise consents in writing, no Indemnified Person shall be indemnified for any expenses, liabilities and losses suffered that are attributable to actions or omissions by an Indemnified Person or its Affiliates to the extent the act or omission was attributable to such Indemnified Person’s or its Affiliates’ breach of this Agreement as determined by a final judgment, order or decree of an arbitrator or a court of competent jurisdiction (which is not appealable or with respect to which the time for appeal therefrom has expired and no appeal has been perfected) or for any present or future breaches of any representations, warranties or covenants by such Indemnified Person or its Affiliates’ (excluding, for purposes hereof, the Company’s and its Subsidiaries’), employees, agents or representatives contained herein or in any other agreement with the Company or any of its Subsidiaries; provided, further, that, unless the Board otherwise determines, no Person shall be entitled to indemnification hereunder with respect to a proceeding initiated by such Person or with respect to a proceeding between such Person on the one hand and either of the Company or its Subsidiaries on the other (other than a proceeding to enforce such Indemnified Person’s rights under this Section 6.04).  Expenses, including attorneys’ fees and expenses, incurred by any such Indemnified Person in defending a proceeding (but not a proceeding initiated by such Indemnified Person, other than a proceeding to enforce such Indemnified Person’s rights under this Section 6.04) may be paid by the Company in advance of the final disposition of such proceeding, including any appeal therefrom, upon approval of the Board and receipt of an undertaking by or on behalf of such Indemnified Person (in form and substance acceptable to the Board) to repay such amount if it shall ultimately be determined that such Indemnified Person is not entitled to be indemnified by the Company.

  (b)	Nonexclusivity of Rights.  The right to indemnification and the advancement of expenses conferred in this Section 6.04 shall not be exclusive of any other right which any Person may have or hereafter acquire under any statute, agreement, law, vote of the Board or otherwise (such other rights, “Supplemental Indemnification Rights”).  The Board may grant any rights comparable to those set forth in this Section 6.04 to any employee, agent or representative of the Company or such other Persons as it may 

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  determine.  In the event any provider of Supplemental Indemnification Rights pays any amount with respect to an Indemnified Person, such provider of Supplemental Indemnification Rights shall be subrogated to such Indemnified Person’s rights to indemnification hereunder to the extent of payment made by such holder of Supplemental Indemnification Rights on behalf of such Indemnified Person.  The Company and each Unitholder acknowledge and agree that the indemnification obligations of the Company hereunder and under any insurance policy contemplated pursuant to Section 6.04(d) shall be deemed primary coverage and in no event shall the Company (or any provider of insurance pursuant to Section 6.04(d)) be entitled to any contribution from any provider of Supplemental Indemnification Rights.

  (c)	Primacy of Obligations.  In furtherance of Section 6.04(b), the Company acknowledges that certain Indemnified Persons may have rights to indemnification, advancement of expenses and/or insurance provided by OXB, HMI and/or certain of its Affiliates (collectively, the “Alternative Indemnitors”).  The Company hereby agrees (i) that it is the indemnitor of first resort (i.e., its obligations to such Indemnified Persons are primary and any obligation of any Alternative Indemnitor, as applicable, to advance expenses or to provide indemnification for the same expenses or liabilities incurred by such Indemnified Persons are secondary), (ii) that it shall be required to advance the full amount of expenses incurred by such Indemnified Persons and shall be liable for the full amount of all expenses, judgments, penalties, fines and amounts paid in settlement to the extent legally permitted and as required by the terms of this Agreement (or any other agreement between the Company and such Indemnified Persons), without regard to any rights such Indemnified Persons may have against the respective Alternative Indemnitors, and (iii) that it irrevocably waives, relinquishes and releases the Alternative Indemnitors from any and all claims against the Alternative Indemnitors for contribution, subrogation or any other recovery of any kind in respect thereof.  The Company further agrees that no advancement or payment by the applicable Alternative Indemnitors on behalf of any such Indemnified Person with respect to any claim for which such Indemnified Person has sought indemnification from the Company shall affect the foregoing, and such Alternative Indemnitors shall have a right of contribution and/or be subrogated to the extent of any such advancement or payment to all of the rights of recovery of such Indemnified Person against the Company.  The Company agrees that the Alternative Indemnitors are express third-party beneficiaries of the terms of this Section 6.04(c).

  (d)	Insurance.  The Company may maintain insurance, at its expense, to protect any Indemnified Person against any expense, liability or loss of the nature described in Section 6.04(a) above whether or not the Company would have the power to indemnify such Indemnified Person against such expense, liability or loss under the provisions of this Section 6.04.  If the Company does obtain such insurance, each Director shall be entitled to the same benefits under such insurance as each other Director.  The Company shall ensure that any such insurance policies comply with Section 6.04(b), including that there be no right of contribution against any provider of Supplemental Indemnification Rights and that providers of Supplemental Indemnification Rights are subrogated to an Indemnified Person’s rights under such insurance policies.

  (e)	Limitation.  Notwithstanding anything contained herein to the contrary (including in this Section 6.04), any indemnity by the Company relating to the matters covered in this Section 6.04 shall be provided out of and to the extent of the Company’s assets only, and no Unitholder (unless such Unitholder otherwise agrees in writing or is found in a final decision by a court of competent jurisdiction to have personal liability on account thereof) shall have personal liability on account thereof or shall be required to make additional Capital Contributions to help satisfy such indemnity of the Company (except as expressly provided herein).

  (f)	Savings Clause.  If this Section 6.04 or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Company shall nevertheless indemnify and hold harmless each Indemnified Person pursuant to this Section 6.04 to the fullest extent permitted by any 

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  applicable portion of this Section 6.04 that shall not have been invalidated and to the fullest extent permitted by applicable law.  The indemnification provisions set forth in this Section 6.04 shall be deemed to be a contract between the Company and each of the persons constituting Indemnified Persons at any time while the provisions of Section 6.04 remain in effect, whether or not such Person continues to serve in such capacity and whether or not such Person is a party hereto.  In addition, this Section 6.04 cannot be retroactively amended to adversely affect the rights of any Indemnified Persons arising in connection with any acts, omissions, facts or circumstances occurring prior to such amendment.

  Section 6.05.	Unitholders’ Right to Act.  Except as expressly and specifically provided in this Agreement (for example, with respect to matters requiring the consent of any Person required under Section 14.01), no Unitholder shall have any right to vote on, approve or consent to any Company matter, including, without limitation, any matter described in Section 6.01.  Without limiting the other provisions of this Agreement, no Unitholder shall owe any obligations or duties (including fiduciary duties) to the Company or any other Unitholder with respect actions taken by such Unitholder.

  Section 6.06.	Investment Opportunities and Conflicts of Interest. The Unitholders (on behalf of themselves and their Affiliates and representatives and including, for the avoidance of doubt, OXB , HMI, or any of the OXB Directors or the HMI Director, and collectively for purposes of this Section 6.06, the “Specified Persons”) expressly acknowledge and agree that any business opportunities that are, from time to time, presented to any Specified Person or of which any Specified Person otherwise becomes aware relating to the manufacturing of adeno-associated vectors using transient transfection (each, an “AAV Opportunity”) and/or plasmid DNA manufacture by bacterial fermentation (each a “Plasmid Opportunity” and, together with an AAV Opportunity, an “Opportunity”) shall be presented in writing by or on behalf of such Specified Person to the CEO, [***]. For the avoidance of doubt, the involvement of OXB or any of its Affiliates, in their respective capacities as Specified Persons, in any such Opportunity in accordance with this Section 6.06 will not constitute a conflict of interest or breach of this Agreement.

  Section 6.07.	Confidentiality.  

  (a)	Each Unitholder agrees that it will not disclose any Confidential Information without the prior written consent of the Company, except in all instances, subject to Section 6.06 in all respects, (x) OXB may disclose Confidential Information to its Affiliates and its and its Affiliates’ respective managers, directors, officers, shareholders, partners, members, employees, representatives, and agents, (y) with respect to other Unitholders, to its employees, auditors, advisors, partners, prospective partners, investors, prospective investors or counsel or to any other Unitholder if it or its holding or parent company reasonably determines that any such party should have access to such information, in each case, to the extent such disclosure reasonably relates to the administration of this Agreement; provided, in the case of clause (x) and (y) above, such Persons (i) expressly agree in writing to be subject to the provisions of this Section 6.07 to the same extent as such disclosing Unitholder or (ii) are otherwise bound by customary and equivalent duties and obligations of confidentiality as set forth in this Section 6.07, and (z) as is required to be disclosed by order of a court of competent jurisdiction, administrative body or governmental body, or by subpoena, summons or legal process, or by law, rule or regulation; provided that the Unitholder required to make such disclosure pursuant to clause (z) above shall provide to the Company, to the extent not prohibited by law, rule or regulation, prompt written notice of such disclosure to enable the Company to seek an appropriate protective order or confidential treatment with respect to the Confidential Information required to be disclosed and such Unitholder shall use commercially reasonable efforts to obtain, at the request and expense of the Company, an order or other assurance that confidential treatment shall be accorded to such portion of the Confidential Information required to be disclosed as the Company shall designate. For the avoidance of doubt and notwithstanding anything contained herein to the contrary, but subject in all respects to Section 6.06, it is acknowledged and agreed that the OXB Directors may disclose Confidential Information to OXB and its Affiliates and its and its Affiliates’ respective managers, directors, 

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  officers, shareholders, partners, members, employees, representatives, and agents, provided that such recipients of Confidential Information comply with the provisions of Section 6.06 and this Section 6.07. “Confidential Information” means any and all confidential or proprietary information of and concerning the Business, the Company or the Company Group; provided that Confidential Information shall not include (and any Unitholder may disclose) any information (1) that has become generally available to the public other than as a result of (x) disclosure by a Unitholder or any of its or its Affiliates’ respective managers, directors, officers, shareholders, partners, members, employees, representatives, and agents or (y) a direct or indirect breach of this Section 6.07, (2) that is obtained from a source other than (x) a Unitholder or any of its or its Affiliates’ respective managers, directors, officers, shareholders, partners, members, employees, representatives, and agents or (y) the Company or any of its Subsidiaries, or any of their respective representatives, employees, agents or other service providers, and in each case, who is not known by such Person to be bound by a confidentiality obligation to any Unitholder or any of its Affiliates or the Company or any of its Subsidiaries or (3) is independently developed by such Person or such Person’s Affiliates without reference to the Confidential Information.  

  (b)	Notwithstanding the foregoing, each Unitholder and each other Person to whom such Unitholder has provided such information as permitted by this Section 6.07 may disclose Confidential Information  as may be required in any report, statement or testimony submitted to (A) any municipal, state or federal regulatory body, rating agency or self-regulatory organization (including the National Association of Insurance Commissioners and any state insurance regulators) having or claiming to have jurisdiction over such Unitholder or its beneficial owner or,  as may be required in respect of any summons or subpoena or in connection with any litigation, and  in order to comply with any law, order, regulation or ruling applicable to such Unitholder or Person; provided that such Unitholder or Person shall only disclose Confidential Information to the minimum extent necessary to comply with any such requirement; provided, further, that with respect to clause (i), to the extent practicable, such Unitholder or Person shall in each such case promptly inform the Company of such requirement and shall cooperate with the Company in attempting to obtain a protective order or to otherwise restrict such disclosure or shall otherwise use commercially reasonable efforts to seek confidential treatment of such information; provided, further, that with respect to clauses (ii) or (iii), such Unitholder or Person shall in each such case promptly inform the Company of such requirement and shall reasonably cooperate with the Company in attempting to obtain a protective order or to otherwise restrict such disclosure. Each Unitholder understands that the restrictions set forth in this Section 6.07 will survive and continue to apply after this Agreement terminates for a period of two years after such termination.  Each Unitholder acknowledges and agrees that the covenants under this Section 6.07 have a unique, substantial and immeasurable value to the Company Group, and that, as a result of the foregoing, in the event of any breach hereof monetary damages would be an insufficient remedy for the Company Group and equitable enforcement of such covenant would be proper.  Therefore, each Unitholder agrees that the Company and each member of the Company Group, in addition to any other remedies available to it, shall be entitled to seek preliminary and permanent injunctive relief against any breach of the covenants set forth in this Section 6.07, without the necessity of posting of a bond or other security.  Notwithstanding anything to the contrary herein, none of the foregoing provisions in any way limits HMI’s confidentiality obligations set forth in the Purchase Agreement or Contribution Agreement or otherwise arising from the contemplated transactions.

  Section 6.08.	Non-Solicitation.  For a period commencing on the date of this Agreement and ending on the shorter of (a) 12 months following the date hereof and (b) the maximum period permitted by applicable law in each applicable jurisdiction, (i) neither OXB nor HMI shall, directly or indirectly, hire or solicit for hire any employee of the Company or any of its Subsidiaries and (ii) the Company shall not hire or solicit for hire any employee of any of OXB or HMI; provided that OXB and HMI may mutually agree in writing to waive this provision as to any employee; and provided, further, that nothing in this Section 6.08 shall prohibit general advertisements not specifically targeted at any such employee to the extent that neither clause (i) nor clause (ii) of this Section 6.08 is breached in connection therewith.

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  ARTICLE VII
RECORDS, ACCOUNTING; INSPECTION

  Section 7.01.	Records and Accounting.  The Company shall keep, or cause to be kept, appropriate books and records with respect to the Company’s business.  The Company will deliver the following to each Unitholder: (a) annual audited financial statements of the Company within 50 days after the end of each Fiscal Year prepared in accordance with or adjusted to comply with GAAP; (b) quarterly unaudited financial statements of the Company within 25 days after the end of each Fiscal Quarter prepared in accordance with or adjusted to comply with GAAP; (c) a final copy of the Board-approved annual operating budget forecasting the Company’s revenues, expenses, and cash position for each Fiscal Year promptly following the Company’s adoption at the start of each Fiscal Year; and (d) such other financial information regarding the Company and its financial performance that is required for each Unitholder to complete its FCA or SEC (or any other applicable regulatory) filings and file its tax returns.  All matters concerning (x) the determination of the relative amount of allocations and Distributions among the Unitholders pursuant to ARTICLE III and ARTICLE IV not specifically and expressly provided by the terms of this Agreement, and (y) accounting procedures and determinations, and other determinations not specifically and expressly provided by the terms of this Agreement, shall be determined by the Board in good faith, which determination shall be final and conclusive as to all of the Unitholders absent manifest clerical error.

  Section 7.02.	Transmission of Communications.  Each Person that owns or controls Units on behalf of, or for the benefit of, another Person or Persons shall be responsible for conveying any report, notice or other communication received from the Company to such other Person or Persons.

  ARTICLE VIII
TAX MATTERS

  Section 8.01.	Preparation of Tax Returns. As soon as reasonably practicable after the end of each Fiscal Year, but in no event later than 75 days after the end of such Fiscal Year, the Company shall send to each Person that was a Unitholder at any time during such Fiscal Year, U.S. Internal Revenue Service Schedule K-l, “Partner’s Share of Income, Credits, Deductions, Etc.,” or any successor schedule or form, for such Person.  Except as otherwise expressly provided in this Agreement, the Company’s tax returns, including all applicable elections, and any matters relating to taxes, shall be prepared, made or determined in the Board’s reasonable discretion.

  Section 8.02.	Tax Controversies.

  (a)	The “partnership representative” of the Company within the meaning of Section 6223 of the Code shall be OXB or such other Person designated from time to time by the Board subject to replacement by the Board (any Person who is designated as the partnership representative is referred to herein as the “Company Representative”). The Company Representative shall be permitted to select any eligible individual to act as the “designated individual” of the Company within the meaning of Treasury Regulations Section 3011.6223-1(b)(3)(ii) (the “Designated Individual”). The Company Representative shall inform each Unitholder of all significant matters that may come to its attention in its capacity as Company Representative and shall forward to each Unitholder copies of all significant written communications it may receive in that capacity. Any reasonable, documented cost or expense incurred by the Company Representative in connection with its duties, including the preparation for or pursuance of administrative or judicial proceedings, shall be paid by the Company. The Company Representative shall not enter into any extension of the period of limitations for making assessments on behalf of the Unitholders or bind any Unitholders to a settlement agreement without first obtaining the consent of a majority interest 

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  of the Unitholders or, if the settlement would have an adverse and disproportionate impact, other than an immaterial impact, on HMI, without the consent of HMI.

  (b)	For any tax year in which the Company is eligible to make the election described in Section 6221(b) of the Code, the Company shall so elect out and each Unitholder agrees not to take any action that would cause the Company to be ineligible to so elect out. For any tax year in which the Company is not able to make the election described in Section 6221(b) of the Code and is eligible to make an election under Section 6226(a) of the Code, the Company may, in the reasonable discretion of the Company Representative, so elect and each Member agrees not to take any action that would cause the Company to be ineligible to so elect.

  (c)	Subject to Section 5.01(b), each Unitholder agrees to reasonably cooperate with the Company Representative in connection with the taxation matters of the Company and to do or refrain from doing any or all things reasonably requested by the Company Representative with respect to the conduct of any tax proceedings. 

  (d)	The provisions of this Section 8.02 shall survive the Unitholders’ ceasing to be a Unitholder of the Company indefinitely.

  Section 8.03.	Section 754 Election.  The Company shall make an election pursuant to Section 754 of the Code (and any corresponding election for state and local income Tax purposes) in connection with any Transfer of Units in the Company or Distributions to Unitholders.

  ARTICLE IX
TRANSFER OF UNITS

  Section 9.01.	Required Consent.

  (a)	Other than (i) to a Permitted Transferee and (ii) Transfers expressly contemplated by Section 9.02, Section 9.03, Section 9.04 or Section 9.05, no Unitholder shall Transfer at any time any interest in any Units.  If a Unitholder Transfers any interests in any Units to a Permitted Transferee and such Transferee ceases to be a Permitted Transferee of such Unitholder, then such Transferee shall, prior to ceasing to be a Permitted Transferee, Transfer such interest to the Unitholder (or other Permitted Transferee thereof) who made such Transfer.  

  (b)	No Unitholder shall or shall seek to avoid, directly or indirectly, the provisions of this Agreement by (i) making one or more Transfers to one or more Permitted Transferees and then disposing of all or any portion of such Person’s interest in any such Permitted Transferee, or (ii) issuing or permitting any Transfer of any equity securities of or interests in such Unitholder.  Each Unitholder that is not a natural Person shall cause the holders of legal and beneficial interests in such Unitholder to not avoid the provisions of this Agreement by disposing of all or any portion of such Person’s interest in such Unitholder.  Any Transfer or attempted Transfer in violation of Section 9.01(a) or this Section 9.01(b) shall be void and otherwise subject to ARTICLE IX.  Notwithstanding anything herein to the contrary, in no event shall this Section 9.01(b) apply to any direct or indirect Transfer or issuance of all or any portion of any direct interest in OXB or HMI, or their respective direct or indirect equityholders.

  Section 9.02.	Tag Along Rights.

  (a)	Participation Right.  Except for Transfers (i) pursuant to Section 9.03, (ii) to a Permitted Transferee or (iii) arising out of an OXB Change of Control, in the event OXB desires to Transfer any outstanding Common Units (any such transaction subject to this Section 9.02, a “Tag Along Sale”), 

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  OXB, desiring to effect such Tag Along Sale (the “Selling Unitholders”) shall give written notice, at least 10 days prior to any such Tag Along Sale, to each Unitholder holding one or more of the same classes of Units proposed to be Transferred (the “Tag Along Rights Holders” and such written notice, the “Tag Along Sale Notice”) specifying in reasonable detail the identity of the prospective Transferee(s), the number and class of Units to be Transferred and the material terms and conditions of the Transfer.  The Tag Along Rights Holders may irrevocably elect to participate in such Tag Along Sale by giving written notice of such irrevocable election to the Selling Unitholders within five days after delivery of the Tag Along Sale Notice (such Unitholders delivering such notice of election in accordance with this Section 9.02, collectively, the “Electing Unitholders”).  For each Electing Unitholder, with respect to the Units for each class of Units to be transferred, such participation shall be based upon the Pro Rata Share represented by the Units of such class requested to be included in such Tag Along Sale by such Electing Unitholder relative to the Pro Rata Share of all Units of such class participating in such Tag Along Sale (including the Selling Unitholder and the Electing Unitholders).  Each Unitholder participating in such Tag Along Sale shall Transfer its Units of such class on the same terms and conditions and the aggregate consideration to be paid in connection with such Tag Along Sale to each class of Units to be transferred and shall be allocated among each Unit of such class included therein based on such Unit’s Pro Rata Share, determined based upon the Total Equity Value implied by the price offered in the Tag Along Sale.  If the Tag Along Rights Holders have not elected to participate in the contemplated Transfer (through notice to such effect or expiration of the five day period after delivery of the Tag Along Sale Notice), then the Selling Unitholders may Transfer the Units specified in the Tag Along Sale Notice at a price and on other material terms no more favorable in the aggregate to the Transferee(s) thereof than specified in the Tag Along Sale Notice during the 120 day period beginning with the delivery of the Tag Along Sale Notice.  Any Selling Unitholders’ Units not Transferred during such 120 day period shall be subject to the provisions of this Section 9.02 upon subsequent Transfer.  Each Tag Along Rights Holder shall take all necessary or desirable actions in connection with the consummation of the Tag Along Sale (whether in such Person’s capacity as a Unitholder, Director or otherwise) as reasonably requested by the Selling Unitholders (including (A) executing and delivering any and all agreements, instruments, consents, waivers, releases and other documents in substantially the same forms executed, and on substantially the same terms agreed to, by the Selling Unitholders (including any applicable purchase agreement, stockholders agreement and/or indemnification and/or contribution agreement), (B) furnishing information and copies of documents, (C) filing applications, reports, returns, filings and other documents or instruments with Governmental Authorities, (D) participating in management meetings and preparing pitchbooks and confidential information memorandums, (E) providing assistance with legal, accounting, tax, financial, benefits and other forms of due diligence and (F) cooperating with the Company and the Selling Unitholders with such Tag Along Sale).

  (b)	Participation Procedure; Conditions.  With respect to any Tag Along Sale, each Selling Unitholder shall use commercially reasonable efforts to obtain the agreement of the Transferee to the participation of the Electing Unitholders in such contemplated Tag Along Sale, and no Selling Unitholder shall Transfer any of its Units to any prospective Transferee pursuant to such Tag Along Sale if such prospective Transferee(s) declines to allow the participation of the Electing Unitholders on the terms provided herein, unless in connection with such Tag Along Sale, one or more of the Selling Unitholders or their Affiliates purchase the number and class of Units from each Electing Unitholder which such Electing Unitholder would have been entitled to sell pursuant to Section 9.02(a) at the same price and on the same terms and conditions on which such Units were sold to the Transferee(s).  Each Electing Unitholder Transferring Units pursuant to a Tag Along Sale shall pay its share (determined on a Pro Rata Basis) of the expenses incurred by the Selling Unitholders in connection with such Transfer and each Electing Unitholder shall be obligated to join in any indemnification or other obligation the Selling Unitholders have agreed to in connection with such Tag Along Sale (including any such obligations that relate specifically to a particular Unitholder, such as indemnification with respect to representations and warranties given by a Unitholder regarding such Unitholder’s title to and ownership of Units and tax status; provided that, unless the prospective Transferees permit a Unitholder to give a guarantee, letter of credit or other mechanism 

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  (which shall be dealt with on an individual basis), any escrow of proceeds of any such transaction shall be withheld on a Pro Rata Basis among all participating Unitholders; provided, further, that the Selling Unitholders and Electing Unitholders shall share in indemnification liabilities related to such Tag Along Sale on a Pro Rata Basis (other than liabilities (if any) related solely to a participating Unitholder, which may be several).

  Section 9.03.	Approved Sale; Drag Along Obligations.

  (a)	Approved Sale.  Subject to Section 5.03(c), if OXB approves or desires to pursue a Sale of the Company (an “Approved Sale”), each Unitholder (and each Person that retains voting control of any Units Transferred in accordance with Section 9.01) shall (including in such Person’s capacity as a Director or by causing any Director(s) entitled to be appointed by such Person to) vote for, cooperate with, consent to and raise no objections against, and not otherwise impede or delay, such Approved Sale. Unless otherwise determined by OXB after good faith consultation with HMI, the Board shall establish a special committee of the Board to manage and facilitate the Approved Sale on behalf of the Company and the Unitholders, and the special committee shall have the authority to retain an investment banker with a nationally recognized reputation, attorneys, accountants and other professionals to advise and assist the Company and the special committee regarding the Approved Sale.  In furtherance of the foregoing, if the Approved Sale is structured as a (x) merger or consolidation, each Unitholder shall waive and hereby waives any dissenters rights, appraisal rights or similar rights in connection with such merger or consolidation or (y) sale of Equity Securities, each Unitholder shall agree and hereby agrees to sell and Transfer, and shall sell and Transfer, all (or such lesser portion reflecting such Person’s proportionate interest in the aggregate portion of the Total Equity Value being sold or disposed of in such Approved Sale) of such Unitholder’s Units and other Equity Securities (regardless of whether each such Unitholder has rights to exercise a Put Option hereunder) on the terms and conditions approved by OXB.  Each Unitholder shall take all reasonably necessary or desirable actions in connection with the consummation of the Approved Sale (whether in such Person’s capacity as a Unitholder, Director or otherwise) as reasonably requested by OXB (including (A) executing and delivering any and all agreements, instruments, consents, waivers, releases and other documents in substantially the same forms executed by OXB (including any applicable purchase agreement, stockholders agreement and/or indemnification and/or contribution agreement), (B) furnishing information and copies of documents, (C) filing applications, reports, returns, filings and other documents or instruments with Governmental Authorities, (D) participating in management meetings and preparing pitchbooks and confidential information memorandums, (E) providing assistance with legal, accounting, tax, financial, benefits and other forms of due diligence, and (F) cooperating with the Company and OXB with such Approved Sale).

  (b)	Conditions.  The obligations of the Unitholders with respect to the Approved Sale are subject to the satisfaction of the following conditions:  (i) the consideration payable upon consummation of such Approved Sale to all Unitholders shall be allocated among the Unitholders based upon the Pro Rata Share represented by the Units Transferred by such Unitholder pursuant to such Approved Sale; (ii)   upon the consummation of the Approved Sale, all of the Unitholders of a particular class of Unit shall receive (or shall have the option to receive) the same form of consideration for such class of Unit; and  (iii) if any Unitholder of a particular class of Units are given an option as to the form and amount of consideration to be received or any other right or benefit with respect to the Approved Sale, each other Unitholder of such class of Units shall be given the same option, right or benefit (other than, in the case of clause (ii) and clause (iii) of this Section 9.03(b), any consideration, option, right or benefit to be received by a Unitholder on account of such individual’s employment relationship with the Company or any of its Subsidiaries (e.g., stay bonus, noncompetition agreement or right to reinvest)).

  (c)	Indemnification; Expenses.  Notwithstanding anything to the contrary, the Unitholders shall be obligated to join, on a Pro Rata Basis of such Unitholder’s share of the aggregate 

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  proceeds of such Approved Sale, in any indemnification obligation OXB has agreed to in connection with such Approved Sale (including any such obligations that relate specifically to a particular Unitholder, such as indemnification with respect to representations and warranties given by a Unitholder regarding such Unitholder’s title to and ownership of Units and tax status); provided that (i) unless a prospective Transferee permits a Unitholder to give a guarantee, letter of credit or other mechanism (which shall be dealt with on an individual basis), any escrow of proceeds of any such transaction shall be withheld on a Pro Rata Basis among all Unitholders and (ii) the aggregate liability for any such Unitholder with respect to such indemnification obligations will be limited to the proceeds received by such Unitholder in the Approved Sale (other than in the case of fraud).  Each Unitholder shall enter into any indemnification or contribution or other agreement reasonably requested by OXB to ensure compliance with this Section 9.03(c).  Each Unitholder shall pay its portion (determined on a Pro Rata Basis) of the expenses incurred by the Unitholders pursuant to an Approved Sale to the extent such expenses are incurred for the benefit of all Unitholders (including the costs and expenses (including reasonable attorney’s fees and expenses) incurred in connection with enforcing or implementing the terms and provisions of this Section 9.03).  Expenses incurred by any Unitholder on its own behalf (including the fees and disbursements of counsel, advisors and other Persons retained by such holder in connection with the Approved Sale) will not be considered costs incurred for the benefit of all Unitholders and, to the extent not paid by the Company, will be the responsibility of such Unitholder.  Notwithstanding the foregoing, the Company shall promptly reimburse OXB and HMI for any reasonable out-of-pocket expenses they respectively incur in connection with an Approved Sale.

  (d)	No Grant of Dissenters Rights or Appraisal Rights.  In no manner shall this Section 9.03 be construed to grant to any Unitholder any dissenters rights or appraisal rights.

  (e)	Waiver.  OXB may, in its sole discretion, decide whether or not to pursue, consummate, postpone or abandon any Approved Sale and the terms and conditions thereof.  Neither the Board, OXB nor any of their Affiliates shall have any liability to any other Unitholder arising from, relating to or in connection with the pursuit, consummation, postponement, abandonment or terms and conditions of any such Approved Sale except to the extent OXB shall have failed to comply with the provisions of this Section 9.03.  Subject to the provisions herein, to the maximum extent permitted by law, in connection with any Approved Sale, each Unitholder hereby waives all claims (including claims related to the fairness of the Approved Sale, the price paid (including the type of consideration received) for the Units in such Approved Sale, the process or timing of such Approved Sale, or any similar claim) arising from or relating to an Approved Sale, even if such Approved Sale results in no consideration being paid or payable to such Unitholder.

  Section 9.04.	Put Option; Call Option.

  (a)	Put Option; Call Option.  At any time following the three-year anniversary of the Effective Date, OXB shall have the option, but not the obligation (the “Call Option”), to purchase, or cause any of its Affiliates to purchase, all the Units held by HMI or its Permitted Transferees on the terms set forth in this Section 9.04.  At any time following the three-year anniversary of the Effective Date, HMI or its individual transferees (or its or their respective Affiliates) shall have the option, but not the obligation (the “Put Option”), to require OXB or the Company to purchase all the Units held by HMI or its Permitted Transferees on the terms set forth in this Section 9.04. 

  (b)	Purchase Price of Units.  The purchase price for the Units held by HMI or its Permitted Transferee in connection with the exercise of a Call Option or Put Option, as applicable, shall be equal to the amount to which HMI or its Permitted Transferee would be entitled to receive upon a liquidation of the Company, in accordance with Section 12.02, [***].

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  (c)	Exercise of the Call Option and Put Option.  OXB or its Permitted Transferees may exercise the Call Option, and HMI or its Permitted Transferees may exercise the Put Option, by notifying the other in writing of its desire to exercise the Call Option or Put Option in accordance with this Section 9.04(c), as applicable (the “Option Notice”), at any time on or after the date that is the three-year anniversary of the date hereof.

  (d)	Unitholder Cooperation.  Without limitation of the other provisions of this ARTICLE IX, each Unitholder shall take all necessary or desirable actions in connection with the consummation of the exercise of the rights set forth in this Section 9.04 (whether in such Person’s capacity as a Unitholder, Director or otherwise) as reasonably requested by the selling holders (including (A) executing and delivering any and all agreements, instruments, consents, waivers, releases and other documents in substantially the same forms executed by the selling holders (including any applicable purchase agreement, stockholders agreement and/or indemnification and/or contribution agreement), (B) furnishing information and copies of documents, (C) filing applications, reports, returns, filings and other documents or instruments with Governmental Authorities, (D) participating in management meetings and preparing pitchbooks and confidential information memorandums, (E) providing assistance with legal, accounting, tax, financial, benefits and other forms of due diligence and (F) cooperating with the Company and the selling holders with the exercise of such rights.  

  Section 9.05.	Rights upon a Change of Control of HMI.  Subject to the provisions of this ARTICLE IX, upon a Change of Control of HMI, OXB may purchase all, but not less than all, of the Common Units held by HMI or its Permitted Transferee for a purchase price, payable in cash, equal to the amount to which HMI or its Permitted Transferee would be entitled to receive upon a liquidation of the Company, in accordance with Section 12.02, [***]. For purposes of this Section 9.05, a “Change of Control” means (i) the sale (in one or a series of related transactions and whether by merger, consolidation, reorganization, combination, sale or transfer of HMI’s Equity Securities) of all or substantially all of the assets of HMI to a third party; (ii) a sale (in one or a series of related transactions and whether by merger, consolidation, reorganization, combination, sale or transfer of HMI’s Equity Securities) resulting in more than 50% of the equity interests of HMI being held by a third party; or (iii) a merger, consolidation, recapitalization resulting in ownership of more than 50% of the issued and outstanding voting Equity Securities in HMI by a third party.

  Section 9.06.	Effect of Assignment.

  (a)	Termination of Rights.  Any Unitholder who shall assign any Units or other interest in the Company shall cease to be a Unitholder with respect to such Units or other interest and shall no longer have any rights or privileges of a Unitholder with respect to such Units or other interest, except as provided in Section 9.01 with respect to any Units over which such Person retains voting control; provided that, notwithstanding the foregoing, unless and until the Assignee is admitted as a Substituted Unitholder in accordance with the provisions of ARTICLE X (the “Admission Date”), the Board may, in its sole discretion, reinstate all or any portion of the rights and privileges of such Unitholder with respect to such Units or other interest for any period of time prior to the Admission Date.  Nothing contained herein shall relieve any Unitholder who Transfers any Units or other interest in the Company from any liability of such Unitholder to the Company or the other Unitholders with respect to such Units or other interest that may exist on the Admission Date or that is otherwise specified in the Delaware Act and incorporated into this Agreement or for any liability to the Company or any other Person or for any breaches of any representations, warranties or covenants by such Unitholder (in its capacity as such) contained herein or in the other agreements with the Company or any of its Subsidiaries or Affiliates.

  (b)	Deemed Agreement.  Any Person who acquires in any manner whatsoever any Units or other interest in the Company, irrespective of whether such Person has accepted and adopted in writing 

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  the terms and provisions of this Agreement, shall be deemed by the acceptance of the benefits of the acquisition thereof, to have agreed to be subject to and bound by all of the terms and conditions of this Agreement that any predecessor in such Units or other interest in the Company of such Person was subject to or by which such predecessor was bound.

  (c)	Assignee’s Rights.  A Transfer of Units permitted hereunder shall be effective as of the date of assignment and compliance with the conditions to such Transfer and such Transfer shall be shown on the books and records of the Company.  Distributions made before the effective date of such Transfer shall be paid to the Transferor, and Distributions made after such date shall be paid to the Assignee.  Unless and until an Assignee becomes a Unitholder pursuant to ARTICLE X hereof, the Assignee shall not be entitled to any of the rights or privileges granted to a Unitholder hereunder or under applicable law, other than the rights and privileges specifically granted to Assignees pursuant to this Agreement; such Assignee shall be bound by any limitations and obligations of a Unitholder contained herein by which a Unitholder would be bound on account of the ownership of Units by the Assignee (including the obligation, if any, to make Capital Contributions on account of such Units and the obligations set forth in ARTICLE IX).

  (d)	Execution of Counterpart.  Except in connection with an Approved Sale, each Transferee of Units or other interests in the Company shall, as a condition prior to such Transfer, execute and deliver to the Company a joinder or counterpart to this Agreement in form and substance acceptable to the Board pursuant to which such Transferee shall agree to be bound by the provisions of this Agreement.

  (e)	Notice.  In connection with the Transfer of any Units (other than pursuant to Section 9.02, Section 9.03, Section 9.04 or Section 10.01), the holder of such Units will deliver written notice to the Company describing in reasonable detail the Transfer or proposed Transfer.

  Section 9.07.	Transfer Fees and Expenses.  Except for a Transfer pursuant to Section 9.02 or Section 9.03, the Transferor and Transferee of any Units or other interest in the Company shall be jointly and severally obligated to reimburse the Company for all reasonable expenses (including attorneys’ fees and expenses) of any Transfer or proposed Transfer, whether or not consummated.

  Section 9.08.	Void Transfers.  Except pursuant to Section 10.01, any Transfer by any Unitholder of any Units or other interest in the Company in contravention of this Agreement, or which would cause the Company to not be treated as a partnership for U.S. federal income tax purposes, shall be void and ineffectual and shall not bind or be recognized by the Company or any other party.  No purported assignee shall have any right to any Distributions of the Company.

  Section 9.09.	Section 7704 Limits.  Notwithstanding anything to the contrary in this Agreement, no Transfer of any Unit or economic interest shall be permitted or recognized by the Company or the Board (within the meaning of Treasury Regulations Section 1.7704-1(d)) if such Transfer (i) would cause the Company to have more than 100 partners, as determined for purposes of Treasury Regulations Section 1.7704-1(h) or (ii) would cause the Company to (or create any risk that the Company would) be treated as a publicly traded partnership within the meaning of Section 7704 of the Code and Treasury Regulations Section 1.7704-1, or (iii) cause the Company to fail to qualify for any “safe harbor” provided for in Section 7704 of the Code and the Treasury Regulations thereunder that otherwise would have been available.

  ARTICLE X
ADMISSION OF UNITHOLDERS

  Section 10.01.	Substituted Unitholders.  In connection with any Transfer of Units by a Unitholder permitted by and in accordance with the terms of ARTICLE IX hereof, the Transferee shall 

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  become a Substituted Unitholder on the later of (a) the effective date of such Transfer, and (b) the date on which the Board approves such Transferee as a Substituted Unitholder (such approval not to be unreasonably withheld, conditioned or delayed), and such admission shall be shown on the books and records of the Company; provided, however, in connection with the Transfer of Units by a Unitholder to a Permitted Transferee permitted under the terms of this Agreement and the other agreements contemplated hereby and thereby, the Transferee shall become a Substituted Unitholder on the effective date of such Transfer.

  Section 10.02.	Additional Unitholders.  A Person may be admitted to the Company as an Additional Unitholder only as contemplated under Section 3.02 and only upon furnishing to the Company (a) a joinder or counterpart to this Agreement in form and substance acceptable to the Board pursuant to which such Person shall agree to be bound by the provisions of this Agreement, and (b) such other documents or instruments as may be deemed necessary or appropriate by the Board to effect such Person’s admission as a Unitholder.  Such admission shall become effective on the date on which the Board determines that such conditions have been satisfied and when any such admission is shown on the books and records of the Company.

  ARTICLE XI
WITHDRAWAL OF UNITHOLDERS

  Section 11.01.	Withdrawal of Unitholders.  No Unitholder shall have the power or right to disclaim or abandon such Unitholder’s Units or otherwise withdraw from the Company or cease to be subject to the provisions of this Agreement prior to the dissolution and winding up of the Company pursuant to ARTICLE XII, without the prior written consent of the Board (which consent may be withheld by the Board in each’s Directors’ sole discretion), except as otherwise expressly permitted by this Agreement.  Upon a Transfer of all of a Unitholder’s Units in a Transfer permitted by this Agreement, such Unitholder shall cease to be a Unitholder.  Notwithstanding that payment on account of a withdrawal may be made after the effective time of such withdrawal, any completely withdrawing Unitholder will not be considered a Unitholder for any purpose after the effective time of such complete withdrawal, and, in the case of a partial withdrawal, such Unitholder’s Capital Account (and corresponding voting and other rights) shall be reduced for all other purposes hereunder upon the effective time of such partial withdrawal.

  ARTICLE XII
DISSOLUTION AND LIQUIDATION

  Section 12.01.	Dissolution.  Subject to Section 5.03(b) and Section 5.03(c), the Company shall dissolve, and its affairs shall be wound up upon the first of the following to occur:

  (a)	the election of the Board (with the prior written consent of OXB); and

  (b)	a Sale of the Company.

  (c)	Except as otherwise set forth in this ARTICLE XII, the Company is intended to have perpetual existence.  An Event of Withdrawal shall not cause a dissolution of the Company and the Company shall continue in existence subject to the terms and conditions of this Agreement.

  Section 12.02.	Liquidation and Termination.  On the dissolution of the Company, the Board shall act as liquidator or may appoint one or more representatives, Unitholders or other Persons as liquidator(s) (with the prior written approval of OXB).  The liquidators shall proceed diligently to wind up the affairs of the Company and make final Distributions as provided herein and in the Delaware Act.  The costs of liquidation shall be borne as the Company’s expense.  Until final Distribution, the liquidators shall 

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  continue to operate Company properties with all of the power and authority of the Board.  The steps to be accomplished by the liquidators are as follows:

  (a)	The liquidators shall pay, satisfy or discharge from the Company’s funds all of the debts, liabilities and obligations of the Company (including all expenses incurred in liquidation) or otherwise make adequate provision for payment and discharge thereof (including the establishment of a cash fund for contingent liabilities in such amount and for such term as the liquidators may reasonably determine).

  (b)	As promptly as practicable after dissolution, the liquidators shall (i) determine the Fair Market Value (the “Liquidation FMV”) of the Company’s remaining assets (the “Liquidation Assets”) in accordance with ARTICLE XIII hereof, (ii) determine the amounts to be distributed to each Unitholder in accordance with Section 4.01, and (iii) deliver to each Unitholder a statement (the “Liquidation Statement”) setting forth the Liquidation FMV and the amounts and recipients of such Distributions, which Liquidation Statement shall be final and binding on all Unitholders.

  (c)	As soon as the Liquidation FMV and the proper amounts of Distributions have been determined in accordance with Section 12.02(b), the liquidators shall promptly distribute the Company’s Liquidation Assets to the holders of Units in accordance with Section 4.01.  In making such Distributions, the liquidators shall allocate each type of Liquidation Assets (e.g., cash or cash equivalents, preferred or common equity securities) among the Unitholders ratably based upon the aggregate amounts to be distributed with respect to the Units held by each such holder; provided that the liquidators may allocate each type of Liquidation Assets so as to give effect to and take into account the relative priorities of the different Units.  Any non-cash Liquidation Assets will first be written up or down to their Fair Market Value, thus creating Profit or Loss (if any), which shall be allocated in accordance with Section 4.01.  If any Unitholder’s Capital Account is not equal to the amount to be distributed to such Unitholder pursuant to Section 12.02(b), Profits and Losses for the Fiscal Year in which the Company is dissolved shall be allocated among the Unitholders in such a manner as to cause, to the extent possible, each Unitholder’s Capital Account to be equal to the amount to be distributed to such Unitholder pursuant to Section 112.02(b).  The Distribution of cash and/or property to a Unitholder in accordance with the provisions of this Section 12.02(c) constitutes a complete Distribution to the Unitholder of its interest in the Company and all Company property and constitutes a compromise to which all Unitholders have consented within the meaning of the Delaware Act.  To the extent that a Unitholder returns funds to the Company, it has no claim against any other Unitholder for those funds.

  Section 12.03.	Securityholders Agreement.  To the extent that units or other equity securities of any Subsidiary are distributed to any Unitholders and unless otherwise agreed to by the Board, such Unitholders hereby agree to enter into a securityholder’s agreement with such Subsidiary and each other Unitholder which contains rights and restrictions in form and substance similar to the provisions and restrictions set forth herein (including in ARTICLE V and ARTICLE IX).

  Section 12.04.	Cancellation of Certificate.  On completion of the Distribution of the Company’s assets as provided herein, the Company shall be terminated (and the Company shall not be terminated prior to such time), and the Board (or such other Person or Persons as the Delaware Act may require or permit) shall file a certificate of cancellation with the Secretary of State of Delaware, cancel any other filings made pursuant to this Agreement that are or should be canceled and take such other actions as may be necessary to terminate the Company.  The Company shall be deemed to continue in existence for all purposes of this Agreement until it is terminated pursuant to this Section 12.04.

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  Section 12.05.	Reasonable Time for Winding Up.  A reasonable time shall be allowed for the orderly winding up of the business and affairs of the Company and the liquidation of its assets pursuant to Section 12.02 in order to minimize any losses otherwise attendant upon such winding up.

  Section 12.06.	Hart Scott Rodino.  In the event the Hart Scott Rodino Antitrust Improvements Act of 1976 (the “HSR Act”) is applicable to any Unitholder, the dissolution of the Company shall not be consummated until such time as the applicable waiting period (and extensions thereof) under the HSR Act have expired or otherwise been terminated with respect to each such Unitholder.

  ARTICLE XIII
VALUATION

  Section 13.01.	Valuation of Units.  The “Fair Market Value” of each Unit shall be the fair value of each such Unit as determined in good faith by the Board and based on the portion of the Total Equity Value to which each such Unit would be entitled as of the date of valuation and using all factors, information and data deemed by them to be pertinent.

  Section 13.02.	Valuation of Securities.  The “Fair Market Value” of any other securities shall mean the average of the closing prices of the sales of the securities on all securities exchanges on which the securities may at the time be listed, or, if there have been no sales on any such exchange on any day, the average of the highest bid and lowest asked prices on all such exchanges at the end of such day, or, if on any day such securities are not so listed, the average of the representative bid and asked prices quoted in the NASDAQ System as of 4:00 P.M., New York time, or, if on any day such securities are not quoted in the NASDAQ System, the average of the highest bid and lowest asked prices on such day in the domestic over the counter market as reported by the National Quotation Bureau Incorporated, or any similar successor organization, in each such case averaged over a period of 21 days consisting of the day as of which the Fair Market Value is being determined and the 20 consecutive Business Days prior to such day.  If at any time the securities are not listed on any securities exchange or quoted in the NASDAQ System or the over the counter market, the Fair Market Value of each such security shall be equal to the fair value thereof as of the date of valuation as determined by the Board in good faith.

  Section 13.03.	Valuation of Other Assets.  The “Fair Market Value” of all other non-cash assets shall mean the fair value thereof as of the date of valuation as reasonably determined by the Board in good faith on the basis of an orderly sale to a willing, unaffiliated buyer in an arm’s-length transaction occurring on the date of valuation, taking into account all relevant factors determinative of value as the Board reasonably deems relevant (and giving effect to any transfer Taxes payable or discounts in connection with such sale).

  Section 13.04.	Dispute Resolution. If a Unitholder disagrees with the Board’s determination of Fair Market Value for any reason or purpose in this Agreement, such Unitholder  (a “Disputing Unitholder”) shall deliver to the Board written notice (a “Dispute Notice”) of such dispute within ten Business Days of its receipt of the Board’s determination of  Fair Market Value.  The Dispute Notice shall set forth the initial determination of such Disputing Unitholder of the Fair Market Value of the Units.  The Board and the Disputing Unitholder shall then negotiate in good faith, including through reasonable engagement of such parties and their respective counsels, for ten (10) Business Days (or for such longer period as they mutually agree) in an effort to reach agreement on the Fair Market Value of the Units. If such negotiation is unsuccessful, the Board and the Disputing Unitholder shall promptly designate a mutually agreeable independent valuation firm, acting as a valuation expert and not as an arbitrator to resolve any remaining disputes set forth in the Dispute Notice in accordance with this Section 13.04.  No later than the fifth Business Day after appointment of the independent appraiser, each of the Board and the Disputing Unitholder shall deliver to the independent appraiser a written notice of its final determination 

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  of the Fair Market Value of the Units (each, a “Valuation Notice”).  The independent appraiser shall be instructed to determine the final Fair Market Value of the Units within 30 calendar days of its receipt of both Valuation Notices.  In making such determination, the independent appraiser (x) shall be instructed that the initial determinations by each of the Board and the Disputing Unitholder of the Fair Market Value shall not be used as evidence of the actual Fair Market Value or the correctness of either the Board’s or the Disputing Unitholder’s determination of the Fair Market Value set forth in the Valuation Notice and (y) may request additional submissions of information from the Board and/or the Disputing Notice (and the Board and/or the Disputing Unitholder shall promptly comply).  The opinion of the independent appraiser shall be binding upon the Company, the Board and the Disputing Unitholder.  The fees and expenses of the independent appraiser shall be borne equally by the Company and the Disputing Unitholder.

  ARTICLE XIV
GENERAL PROVISIONS

  Section 14.01.	Amendments.  Subject (x) in all respects to Section 5.03(b) and Section 5.03(c), and to (i) the right of the Board to amend this Agreement as expressly provided herein (including pursuant to Section 3.02), (ii) any amendment pursuant to a merger or consolidation that is approved in accordance with the terms of this Agreement, (iii) Section 6.04(f) regarding certain indemnification rights, (iv) Section 2.07 regarding the tax treatment of the Company, and (v) the last sentence of Section 3.01(b) regarding capital contributions, this Agreement may be amended, modified, or waived by or with the written consent of OXB or its Permitted Transferee, and such amendment, modification or waiver shall be binding upon and effective as to the Company, the Board and each other Unitholder; provided that any such amendment, modification or waiver that would alter or change the economic rights, economic obligations, economic powers or economic preferences of one or more Unitholders holding Common Units in a disproportionate and materially adverse manner compared to the economic rights, economic obligations, economic powers and economic preferences specific to other Unitholders in their capacities as the holders of Common Units shall also require the prior written consent of the Unitholders so disproportionately and materially adversely affected.

  Section 14.02.	Title to Company Assets.  The Company’s assets shall be deemed to be owned by the Company as an entity, and no Unitholder, individually or collectively, shall have any ownership interest in such assets or any portion thereof.  Legal title to any or all of such assets may be held in the name of the Company or one or more nominees, as the Board may determine.  The Board hereby declares and warrants that any Company assets for which legal title is held in the name of any nominee shall be held in trust by such nominee for the use and benefit of the Company in accordance with the provisions of this Agreement.  All Company assets shall be recorded as the property of the Company on its books and records, irrespective of the name in which legal title to such assets is held.

  Section 14.03.	Remedies.  Each Unitholder and the Company shall have all rights and remedies set forth in this Agreement and all rights and remedies which such Person has been granted at any time under any other agreement or contract and all of the rights which such Person has under any law.  Any Person having any rights under any provision of this Agreement or any other agreements contemplated hereby shall be entitled to enforce such rights specifically (without posting a bond or other security), to recover damages by reason of any breach of any provision of this Agreement and to exercise all other rights granted by law.

  Section 14.04.	Successors and Assigns.  All covenants and agreements contained in this Agreement shall bind and inure to the benefit of the parties hereto and their respective heirs, executors, administrators, successors, legal representatives and permitted assigns, whether so expressed or not.

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  Section 14.05.	Severability.  Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or the effectiveness or validity of any provision in any other jurisdiction, and this Agreement will be reformed, construed and enforced in such jurisdiction as if such invalid, illegal or unenforceable provision had never been contained herein or if such term or provision could be drawn more narrowly so as not to be illegal, invalid, prohibited or unenforceable in such jurisdiction, it shall be so narrowly drawn, as to such jurisdiction, without invalidating the remaining terms and provisions of this Agreement or affecting the legality, validity or enforceability of such term or provision in any other jurisdiction.

  Section 14.06.	Counterparts; Binding Agreement.  This Agreement may be executed simultaneously in two or more separate counterparts, any one of which need not contain the signatures of more than one party, but each of which will be an original and all of which together shall constitute one and the same agreement binding on all the parties hereto.  This Agreement and all of the provisions hereof shall be binding upon and effective as to each Person who (a) is issued or otherwise holds Units (other than as a result of a Transfer by such Unitholder after the date hereof made not in accordance with this Agreement) (whether or not they execute a counterpart to this Agreement), (b) executes this Agreement in the appropriate space provided in the signature pages hereto notwithstanding the fact that other Persons who have not executed this Agreement may be listed on the signature pages hereto and (c) may from time to time become a party to this Agreement by executing a counterpart of or joinder to this Agreement.

  Section 14.07.	Descriptive Headings; Interpretation.  The descriptive headings of this Agreement are inserted for convenience only and do not constitute a substantive part of this Agreement.  Whenever required by the context, any pronoun used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular form of nouns, pronouns and verbs shall include the plural and vice versa.  The use of the word “including” in this Agreement shall be by way of example rather than by limitation.  Reference to any agreement, document or instrument means such agreement, document or instrument as amended or otherwise modified from time to time in accordance with the terms thereof, and if applicable hereof.  Whenever required by the context, references to a Fiscal Year shall refer to a portion thereof.  The use of the words “or,” “either” and “any” shall not be exclusive.  The use of the word “class” shall be deemed to mean “class and/or series.” The parties hereto have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any of the provisions of this Agreement.  Wherever a conflict exists between this Agreement and any other agreement, this Agreement shall control but solely to the extent of such conflict.

  Section 14.08.	Applicable Law; Jurisdiction; Service of Process.  This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware, without giving effect to any choice of law or conflict of law rules or provisions (whether of the State of Delaware or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of Delaware.  Each Unitholder irrevocably submits to the exclusive jurisdiction of the Court of Chancery of the State of Delaware (the “Court of Chancery”) or, to the extent the Court of Chancery does not have subject matter jurisdiction, the United States District Court for the District of Delaware and the appellate courts having jurisdiction of appeals in such courts (the “Delaware Federal Court”) or, to the extent neither the Court of Chancery nor the Delaware Federal Court has subject matter jurisdiction, the Superior Court of the State of Delaware (the “Chosen Courts”), for the purposes of any suit, action or other proceeding arising out of this Agreement or any transaction contemplated hereby and agrees that a final judgment in any such suit, action or other proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.  Each Unitholder further agrees that service 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  of any process, summons, notice or document by United States certified or registered mail to such Unitholder’s respective address set forth in the Company’s books and records or such other address or to the attention of such other person as the recipient party has specified by prior written notice to the sending party shall be effective service of process in any action, suit or proceeding in the Chosen Courts with respect to any matters to which it has submitted to jurisdiction as set forth in the immediately preceding sentence.  Each Unitholder irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the transactions contemplated hereby in the Chosen Courts and hereby irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in such Chosen Courts has been brought in an inconvenient forum.

  Section 14.09.	Addresses and Notices.  All notices, demands or other communications to be given or delivered under or by reason of the provisions of this Agreement shall be in writing and shall be deemed to have been given or made when (a) delivered personally to the recipient, (b) delivered by means of electronic mail (with hard copy sent to the recipient by reputable overnight courier service (charges prepaid) that same day) if emailed before 5:00 p.m. New York City time on a Business Day, and otherwise on the next Business Day, or (c) one Business Day after being sent to the recipient by reputable overnight courier service (charges prepaid).  Such notices, demands and other communications shall be sent to the address for such recipient set forth in the Company’s books and records, or to such other address or to the attention of such other person as the recipient party has specified by prior written notice to the sending party.  Any notice to the Board shall be deemed given if delivered to each member of the Board at the last known address of such members, or in the case of (x) the OXB Directors, the address set forth on the Unit Ownership Ledger and (y) the HMI Director, the address for the HMI Director set forth on the Unit Ownership Ledger.

  Section 14.10.	Creditors.  None of the provisions of this Agreement shall be for the benefit of or enforceable by any creditors of the Company or any of its Affiliates, and no creditor who makes a loan to the Company or any of its Affiliates may have or acquire (except pursuant to the terms of a separate agreement executed by the Company in favor of such creditor) at any time as a result of making the loan any direct or indirect interest in the Company’s Profits, Losses, Distributions, capital or property other than as a secured creditor.  Notwithstanding the foregoing, each of the Indemnified Persons is an intended third-party beneficiary of Section 6.04 and shall be entitled to enforce such provision (as it may be in effect from time to time).

  Section 14.11.	No Waiver.  No failure by any party to insist upon the strict performance of any covenant, duty, agreement or condition of this Agreement or to exercise any right or remedy consequent upon a breach thereof shall constitute a waiver of any such breach or any other covenant, duty, agreement or condition.

  Section 14.12.	Further Action.  The parties agree to execute and deliver all documents, provide all information and take or refrain from taking such actions as may be necessary or appropriate to achieve the purposes of this Agreement.

  Section 14.13.	Escrow for Disputed Amounts.  In the event that OXB has made a claim against HMI for indemnification under and in accordance with Article VIII of the Purchase Agreement (an “Indemnification Claim”), and there is a Disputed Amount outstanding on the date on which a payment is to be paid by OXB or the Company, to HMI pursuant to Section 4.01, Section 9.04 or Section 9.05 of this Agreement (the “Payment Amount”), HMI shall be entitled to receive the Payment Amount less the Disputed Amount, which Disputed Amount shall be deposited into an escrow account with an independent third-party escrow agent mutually agreed in writing by OXB and HMI. Such escrow account shall be 

  41

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  governed by an agreement that shall provide for a release of the Disputed Amounts to the parties based on the resolution of such dispute in accordance with Article VIII of the Purchase Agreement.

  Section 14.14.	Entire Agreement.  This Agreement, each Unitholder’s respective investment agreement, purchase agreement, grant agreement or other similar agreement, the documents expressly referred to herein, related documents of even date herewith, the other agreements contemplated hereby and thereby and any other agreement identified by the Board, in its sole discretion, embody the complete agreement and understanding among the parties and terminate, supersede and preempt any prior understandings, agreements or representations by or among the parties, written or oral, which may have related to the subject matter hereof in any way.

  Section 14.15.	Delivery by Electronic Means.  This Agreement, the agreements referred to herein, and each other agreement or instrument entered into in connection herewith or therewith or contemplated hereby or thereby, and any amendments hereto or thereto, to the extent signed and delivered by means of a facsimile machine or electronic transmission in portable document format (pdf) or comparable electronic transmission, shall be treated in all manner and respects as an original agreement or instrument and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person.  At the request of any party hereto or to any such agreement or instrument, each other party hereto or thereto shall re-execute original forms thereof and deliver them to all other parties.  No party hereto or to any such agreement or instrument shall raise the use of a facsimile machine or pdf electronic transmission or comparable electronic transmission to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of a facsimile machine as a defense to the formation or enforceability of a contract and each such party forever waives any such defense.

  Section 14.16.	Survival.  Section 3.01(b), Section 6.01 and Section 6.04 shall survive and continue in full force in accordance with its terms notwithstanding any termination of this Agreement or the dissolution of the Company.

  Section 14.17.	WAIVER OF JURY TRIAL.  AS A SPECIFICALLY BARGAINED FOR INDUCEMENT FOR EACH OF THE PARTIES HERETO TO ENTER INTO THIS AGREEMENT (AFTER HAVING THE OPPORTUNITY TO CONSULT WITH COUNSEL), EACH PARTY HERETO EXPRESSLY WAIVES THE RIGHT TO TRIAL BY JURY IN ANY LAWSUIT OR PROCEEDING RELATING TO OR ARISING IN ANY WAY FROM THIS AGREEMENT OR THE MATTERS CONTEMPLATED HEREBY.

  Section 14.18.	No Strict Construction.  The parties hereto have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto, and no presumption or burden of proof shall arise favoring or disfavoring any party hereto by virtue of the authorship of any of the provisions of this Agreement.

  *  *  *  *

  42

  

  Confidential

  IN WITNESS WHEREOF, the undersigned have executed or caused to be executed on their behalf this Amended and Restated Limited Liability Company Agreement as of the date first written above.

   

  THE COMPANY

  ROADRUNNER SOLUTIONS LLC

  By:	/s/ Tim Kelly

  Name:	Tim Kelly 

  Title:	Chief Executive Officer

   

  UNITHOLDERS

  OXFORD BIOMEDICA (US), INC.  

   

  By:	/s/ Stuart Paynter

  Name:	Stuart Paynter

  Title:	Chief Financial Officer

  HOMOLOGY MEDICINES, INC.

   

  By:	/s/ Arthur Tzianabos

  Name:	Arthur O. Tzianabos

  Title:	President and Chief Executive Officer 

   

  Signature Page to Amended and Restated Limited Liability Company Agreement of Roadrunner Solutions LLC

  

  Confidential

  AMENDED AND RESTATED LIMITED LIABILITY COMPANY AGREEMENT

  Joinder

  The undersigned hereby agrees to become a party to the Amended and Restated Limited Liability Company Agreement of Roadrunner Solutions LLC, a Delaware limited liability company (the “Company”), dated as of March 10, 2022 (as amended from time to time, the “Agreement”), and shall accept and be subject to, and comply with the terms, conditions and provisions of the Agreement as a “Unitholder” thereunder, and shall be entitled to the rights and benefits and subject to the obligations of a Unitholder thereunder.

  UNITHOLDER:

   

  [_____________________]

   

   

  By: 	___________________________

  Its:

   

   

  Address for Notices:

   

  [______________]

  [______________]

  [______________]

  [______________]

   

   

   

   

   

   

   

  

   

   

  APPENDIX A

  
UNIT OWNERSHIP LEDGER

   

   

  [***]EX-10.27

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

  Exhibit 10.27

   

  MANUFACTURING AND SUPPLY AGREEMENT

  This Manufacturing and Supply Agreement (this “Agreement”), dated as of March 10, 2022 (this “Effective Date”), is entered into by and between Homology Medicines, Inc., a Delaware corporation having an address at One Patriots Park, Bedford, MA 01730 (“HMI”), Roadrunner Solutions LLC, a Delaware limited liability company having an address at One Patriots Park, Bedford, MA 01730 (“Supplier”, and together with HMI, the “Parties”, and each, a “Party”), and, solely for purposes of Section 2.3(b)(iii), Oxford Biomedica UK Limited, a company incorporated in England and Wales with company registration number 03028927, whose registered office is at Windrush Court, Transport Way, Oxford, OX4 6LT, UK (“OXB”).

   

  RECITALS

  WHEREAS, HMI is in the business of developing and commercializing biopharmaceutical products, including gene therapy and gene editing products, and in connection therewith has manufactured such products at a certain manufacturing facility located in Bedford, MA;

  WHEREAS, Supplier is in the business of manufacturing biopharmaceutical products;

  WHEREAS, HMI and Supplier are parties to a certain Contribution Agreement dated as of the date hereof (the “Contribution Agreement”), pursuant to which, among other things, HMI has agreed to assign, transfer, convey to Supplier the Transferred Assets (as defined in the Contribution Agreement), including those that are used, held for use or intended for use by HMI in connection with the manufacturing of pharmaceutical products;

  WHEREAS, as of the Contribution Closing (as defined in the Contribution Agreement) HMI has assigned, transferred and conveyed to Supplier, the Transferred Assets; and

  WHEREAS, as contemplated by the Contribution Agreement, HMI and Supplier have entered into this Agreement to establish the terms and conditions under which Supplier will perform certain development activities, manufacture certain products and supply the same to HMI, including for clinical purposes.

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

  ARTICLE 1

  DEFINITIONS

  Unless otherwise defined herein, defined terms shall have the same meaning as in the Contribution Agreement. For purposes of this Agreement, the following capitalized terms shall have the following definitions:

  LW 12725248

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.1 “Affiliate(s)” means any Person that directly or indirectly, controls, is controlled by, or is under common control with either Party. The term “control”, “controlled by” or “under common control with” means (a) the possession of the power to direct or cause the direction of management and policies of such corporation or business entity, whether through direct or indirect ownership of voting securities or otherwise or (b) the ownership, directly or indirectly, of 50% or more of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). For clarity, for purposes of this Agreement, Supplier and HMI shall not be deemed Affiliates of each other; and Supplier and OXB shall not be deemed Affiliates of each other. 

  1.2 “Agreement” shall have the meaning set forth in the preamble.

  1.3 “Alternate Manufacturer” means (a) HMI, or a Third Party selected by HMI to Manufacture for HMI a Product in (i) [***] or (ii) any other country or region approved by Supplier in writing, such approval not to be unreasonably withheld, delayed or conditioned, or (b) a Third Party described in Section 2.11(a)(iii), or a designee thereof, that requests in writing to Manufacture a Product, provided that such Third Party consults with Supplier with respect to protection of trade secrets to be transferred to enable Manufacturing such Product in any country other than those listed in clause (a)(i) above.

  1.4 “Annual Purchase Minimums” shall have the meaning set forth in Section 2.3(a)(v). 

  1.5 “API” means an active pharmaceutical ingredient as defined by ICH Harmonised Guideline Q7.

  1.6 “Applicable Law” means the applicable Laws of the United States, the European Union and any other jurisdictions as agreed to in writing by both Parties.  

  1.7 “Batch” means the amount of Drug Substance or Drug Product [***] by Supplier pursuant to this Agreement.

  1.8 “Binding Forecast” shall have the meaning defined in Section 3.1(b).

  1.9 “Business Day” means any day except Saturday, Sunday or any other day on which commercial banks located in New York or Massachusetts are authorized or required by Law to be closed for business.

  1.10 “Certificate of Analysis” means the document accompanying each Batch of Product delivered by Supplier to HMI demonstrating compliance of the corresponding Batch to the Product Specifications.

  1.11 “cGMP Products” means any Product that is intended to be Manufactured under cGMP. For clarity, cGMP Products are delivered hereunder as Products, whereas any Products that are delivered hereunder that are not intended to be cGMP compliant are delivered as a result of Services hereunder. 

  2

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.12 “Change of Control” means with respect to a Party, the occurrence of any of the following events: (a) the sale, transfer, conveyance or other disposition of all or a majority of the assets of such Party to a Third Party; (b) the acquisition of beneficial ownership, directly or indirectly, by a Third Party of common shares or other equity interests representing more than fifty percent (50%) of the aggregate ordinary voting power of such Party; or (c) a merger, reorganization or consolidation involving such Party and a Third Party in which the stockholders of such Party, immediately prior to the merger, reorganization or consolidation, would not, immediately after the merger, reorganization or consolidation, beneficially own, directly or indirectly, shares representing in the aggregate more than fifty percent (50%) of the combined ordinary voting power of the resulting ultimate parent company; provided that neither of the following shall constitute a Change of Control: (i) a transaction or series of transactions in which (1) a majority of the members of the Board of Directors of such Party prior to such transaction or series of transactions become members of the Board of Directors of the resulting parent company following such transaction(s) and represent a majority of such Board of Directors and (2) a majority of the members of the senior management of such Party prior to such transaction or series of transactions become members of the senior management of the resulting parent company following such transaction(s); or (ii) a public offering of equity securities of such Party or any Affiliate of such Party pursuant to an effective registration statement under the Securities Act of 1933, as amended.	

  1.13 “CMO” means a contract manufacturing organization.

  1.14 “Commercial Product” shall have the meaning defined in Section 2.3(b). 

  1.15 “Commercial Supply Agreement” shall have the meaning defined in Section 2.3(b)(ii).

  1.16 “Confidential Information” shall have the meaning defined in Section 10.1.

  1.17 “Contribution Agreement” shall have the meaning defined in the preamble.

  1.18 “Control” or “Controlled” means, with respect to Intellectual Property Rights, the possession (whether by ownership, license, covenant not to sue or otherwise) by a Party or its Affiliate of the ability to grant to the other Party a license, sublicense, access or other right as provided herein to or under such Intellectual Property Rights, without violating the terms of any agreement or other arrangement of such Party with any Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such license or access, or subjecting the granting Party to any additional fee or charge. 

  1.19 [***].

  1.20 “Defect” means a material quality attribute in a Batch of cGMP Product that does not meet the requirements set forth in the Product Specifications, the Quality Agreement or Applicable Law, in each case applicable to such Product. “Defective” shall have the correlative meaning. 

  1.21 “Demand Based Purchase Minimums” shall have the meaning set forth in Section 2.3(a)(v).

  3

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.22 “Designee” shall have the meaning defined in the Quality Agreement.

  1.23 “Disclosing Party” shall have the meaning defined in Section 10.1.

  1.24 “Dispute” shall have the meaning defined in Section 11.15.

  1.25 “Dispute Notice” shall have the meaning defined in Section 11.15.

  1.26 “Drug Product” means the final dosage form of a product that contains a Drug Substance as the API.

  1.27 “Drug Substance” means the applicable viral vector in liquid bulk or other bulk form.

  1.28 “Drug Substance Batch Price” means (a) with respect to a Named HMI Product, the price for each Batch of the applicable Drug Substance Manufactured and/or supplied by Supplier hereunder, which price shall be [***] as of the Effective Date and may be adjusted in accordance with Section 5.3, and (b) with respect to an Other HMI Product, the price for each Batch of the Drug Substance Manufactured and/or supplied by Supplier hereunder, which price shall be determined and may be adjusted in accordance with Section 5.3.  For clarity, [***].

  1.29 “Effective Date” means the date first set forth in the preamble of this Agreement.

  1.30 “Exploit” means to make, have made, import, export, use, sell, have sold, or offer for sale, including to research, develop, commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of. Cognates of the word “Exploit” shall have correlative meanings.

  1.31 “Explorative Activities” shall have the meaning defined in Section 2.2(a).  

  1.32 “Facility” means the facility or facilities at which Supplier will Manufacture or store biopharmaceutical products after the Effective Date, which as of the Effective Date will be a portion of the facility located at 1 Patriots Park, Bedford, MA 01730 at which HMI Manufactured biopharmaceutical products prior to the Effective Date, or such other facility or facilities at which Supplier will Manufacture or store, or have Manufactured or stored, such products, as mutually agreed to in writing by both Parties.

  1.33 “Filling Price” means with respect to a Drug Product, the price for Manufacturing each Batch of the Drug Product from the applicable Drug Substance using Drug Substance that has already been Manufactured, which price shall be [***] as of the Effective Date, and may be adjusted in accordance with Section 5.3.  For clarity, [***].

  1.34 “Firm Order” means a Purchase Order for Products accepted by Supplier in accordance with Section 3.2(a).

  1.35 “Force Majeure Event” shall have the meaning defined in Section 11.20.

  1.36 “FTE” shall have the meaning defined in Section 2.11(c).

  4

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.37 “FTE Rate” means the dollar amount per full-time equivalent employee (or consultant, as applicable) per year, which amount represents the fully-burdened rate (for calendar year 2023, the FTE Rate shall be the rate set forth in Section 5.4(b)) and shall be determined, and may be adjusted, in accordance with Section 5.4. 

  1.38 “GAAP” means generally accepted accounting principles.

  1.39 “GMP” or “cGMP” means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4 - Good Manufacturing Practice (GMP) guidelines, parts I to IV and relevant associated annexes, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent Laws in any other regulatory jurisdictions as agreed to in writing by both Parties.

  1.40 “Governmental Authority” means any federal, state, local or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political subdivision, or any court or tribunal of competent jurisdiction.

  1.41 “HMI Indemnified Parties” shall have the meaning defined in Section 9.8(a).

  1.42 “HMI Intellectual Property Rights” means all Intellectual Property Rights Controlled by HMI as of the Effective Date or during the Term relating to a Product that is necessary or reasonably useful for Supplier’s performance of its obligations hereunder.

  1.43 “HMI-Owned Inventions” means any and all inventions, discoveries and improvements and Intellectual Property Rights therein that are first conceived or made by or on behalf of one or both Parties under this Agreement that relate specifically to one or more Product(s) and are not generally applicable to Manufacturing of one or more other products that are not Products.

  1.44 “HMI Raw Materials” means raw materials for the Manufacture of Products and performance of Services as may be provided by HMI to Supplier as specified on Appendix 4 of the Quality Agreement or the applicable SOWs, or as mutually agreed to by the Parties in writing.

  1.45 “HMI Raw Materials Warranty” shall have the meaning defined in Section 9.3.

  1.46 “HMI Regulatory Approvals” means all regulatory approvals relating the Products Controlled by HMI as of the Effective Date or during the Term that is necessary or reasonably useful for Supplier’s performance of its obligations hereunder.

  1.47 “Improvement Plan” shall have the meaning defined in Section 2.7(b).

  1.48 “Information” means either Party’s and/or its Affiliates’ confidential information of a commercial, industrial, economic, scientific, medical, or technical nature, whether in written, oral, electronic or other form.

  1.49 “Initial SOW Plan” shall have the meaning defined in Section 2.7(a).

  5

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.50 “Initial Term” shall have the meaning defined in Section 6.1.

  1.51 “Intellectual Property Rights” means all intellectual property rights comprising or relating to: (a) Patents; (b) Trademarks; (c) works of authorship, expressions, designs and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software and firmware, application programming interfaces, architecture, files, records, schematics, data, data files, and databases and other specifications and documentation; (d) Know-How and (e) all industrial and other intellectual property rights, and all rights, interests and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the Laws of any jurisdiction throughout in any part of the world.

  1.52 “Joint Steering Committee” shall have the meaning defined in Section 2.7.

  1.53 “Key Performance Indicators” means certain key performance indicators designed to provide the basis for the Joint Steering Committee’s objective assessment of Supplier’s performance of its Manufacture and supply obligations hereunder. 

  1.54 “Key Positions” shall be listed on Schedule 2.6, as amended from time-to-time by mutual agreement.

  1.55 “Know-How” means any techniques, technology, inventions (whether patentable or not), methods, know-how, data and results (including pharmacological, toxicological and clinical data and results), analytical and quality control data and results, regulatory documents, business and Information, compositions of matter, information and technologies relating to cells, cell lines, assays, animal models, reagents and other physical, biological, or chemical material, that is not in the public domain.

  1.56 “Latent Defect” means any Defect which HMI cannot reasonably notice or be expected to have noticed on visual inspection of the applicable cGMP Product.

  1.57 “Law” means any statute, law, ordinance, regulation, rule, code, directives, constitution, treaty, common law, governmental order or other requirement or rule of law of any Governmental Authority, and Licenses and Permits.

  1.58 “License and Patent Management Agreement” means that certain License and Patent Management Agreement by and between Supplier and HMI, dated on or about the date hereof.

  1.59 “Licenses and Permits” means any and all licenses, authorizations, and permits issued by Governmental Authorities that are necessary for the Manufacture of Products or performance of Services hereunder, including HMI Regulatory Approvals. 

  1.60 “Losses” means any damage and loss suffered by a Party as defined in Section 9.8.

  6

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.61 “Manufacture” and “Manufacturing” means any process (or step in any process) used or planned to be used for manufacturing pharmaceutical products or intermediates thereof, including Products, including quality control, stability and other testing, and primary and secondary packaging.

  1.62 “Manufacturer’s Release” shall have the meaning defined in the Quality Agreement.

  1.63 “Manufacturing Change” shall have the meaning defined in Section 2.4.

  1.64 “Member” shall have the meaning defined in Section 2.7.

  1.65 “Named HMI Product” means the HMI products set forth on Schedule 1.65 hereof.

  1.66 “Notice” shall have the meaning defined in Section 11.4.

  1.67 “Opportunities” shall have the meaning defined in Section 2.3(c)(i). 

  1.68 “Other HMI Products” means any biopharmaceutical product, other than Named HMI Products, that is developed by or on behalf of HMI or its Affiliates, excluding any product developed by or on behalf of HMI’s acquiror or any of such acquiror’s Affiliates (that becomes an Affiliate of HMI after the Effective Date directly or indirectly as a result of a Change of Control of HMI) independently of HMI.

  1.69 “Patent Defect(s)” means any Defect that is capable of being detected upon reasonable visual inspection.

  1.70 “Patents” means (a) all patents, priority patent filings and patent applications, and (b) any divisional, continuation (in whole or in part), or request for continued examination of any of such patents, and patent applications, and any and all patents or certificates of invention issuing thereon, and any and all reissues, reviews, reexaminations, extensions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing.

  1.71 “Permitted Subcontractor(s)” means the Third Party subcontractors or vendors specified in the Quality Agreement, or in the case of Services, as specified in the applicable SOW. 

  1.72 “Person” means any individual, corporation, partnership (whether general, limited or limited liability), association, joint venture, limited liability company, joint stock company, unincorporated organization, trust or other legal entity or organization, having legal personality, or the right to sue in its own name.

  1.73 [***].

  7

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  1.74 “Process” means the Manufacturing process for the Products as reflected in Manufacturing SOPs, process control strategy and process descriptions in use at the Facility(ies) as of the Effective Date or during the Term.

  1.75 “Product” means a Named HMI Product or an Other HMI Product. A Product refers to either (a) the Drug Substance or (b) the Drug Product, as applicable.

  1.76 “Product Specifications” shall have the meaning defined in the Quality Agreement.

  1.77 “Product Warranty” shall have the meaning defined in Section 9.1.

  1.78 “Project Manager” means the individual member of the Joint Steering Committee appointed by a Party with the responsibility for overseeing such Party’s day-to-day activities under this Agreement.

  1.79 “Project Team” shall have the meaning defined in Section 2.8(a).

  1.80 “Purchase Agreement” means that certain Equity Securities Purchase Agreement by and among Supplier, HMI and OXB, dated on or about the date hereof.

  1.81 “Purchase Order” shall have the meaning defined in Section 3.2(a).

  1.82 “Quality Agreement” means the technical agreement(s) notably defining the responsibilities of each Party with respect to the quality of the Products, to be entered into by the Parties on or about the Effective Date which shall once executed be incorporated into this Agreement. In the event of a conflict between the provisions of this Agreement and the Quality Agreement, the provisions of the Quality Agreement shall prevail for the terms and conditions that are solely related to quality assurance aspects and the provisions of this Agreement shall prevail for all other aspects.

  1.83 “Receiving Party” shall have the meaning defined in Section 10.1.

  1.84 “Representatives” means a Party’s Affiliates and each of their respective employees, officers, directors, and agents.

  1.85 “[***]” shall have the meaning defined in [***].

  1.86 “Services” means product development services including Explorative Activities, and other Manufacturing-related services that HMI may request from Supplier from time-to-time hereunder.

  1.87 “SOP” means standard operating procedures.

  1.88 “SOW” means statements of work describing the Services to be performed by Supplier for HMI or its designees. Each SOW will be numbered for identification and will set forth the material terms of the applicable services, the scope of work, specified services, deliverables, estimated timelines, milestones (if any), service fees, payment schedules and such 

  8

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  other details and special arrangements as are agreed to by the Parties with respect to the activities to be performed under such SOW. The Initial SOW Plan is an SOW. An exemplary form SOW is attached hereto as Exhibit A.

  1.89 “Supplier Indemnified Parties” shall have the meaning defined in Section 9.8(b).

  1.90“Supplier Intellectual Property Rights” means all Intellectual Property Rights Controlled by Supplier or its Affiliates as of the Effective Date or during the Term that are used by Supplier to Manufacture the Products or are necessary for the exploitation of Products.

  1.91 “Supplier-Owned Inventions” means any and all inventions, discoveries and improvements and Intellectual Property Rights therein that are first conceived or made by or on behalf of one or both Parties under this Agreement that are not HMI-Owned Inventions and relate to Manufacturing of products generally.

  1.92 “Supplier-Sourced Materials Cost” shall have the meaning defined in Section 3.4(b). 

  1.93 “Supply Failure” means, for any Product, that Supplier has failed to supply [***]. 

  1.94 “Technology Transfer” shall have the meaning defined in Section 2.11.

  1.95 “Term” shall have the meaning defined in Section 6.2.

  1.96 “Third Party” means a Person other than (a) HMI or any of its Affiliates and (b) Supplier or any of its Affiliates.

  1.97 “Third Party Claims” shall have the meaning defined in Section 9.8(a).

  1.98 “Trademarks” means any trademark, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, whether or not registered, including the goodwill and activities associated with each of the foregoing.

  1.99 “Transferred Assets” shall have the meaning defined in the Contribution Agreement.

  1.100 “Transition Services Agreement” means that certain transition services agreement to be entered into by and between the Parties and effective on the date herewith.

  1.101 “[***] Forecast” shall have the meaning defined in Section 3.1(b).

  ARTICLE 2
SUPPLY OF PRODUCTS AND RELATED SERVICES

  2.1 Manufacture and Supply. Subject to the terms and conditions of this Agreement, HMI hereby agrees to purchase from Supplier its requirements of Products and Supplier shall Manufacture and supply such Products to HMI in accordance with the terms and conditions set forth in this Agreement and in a professional manner, in conformance with the level of care 

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  and skill ordinarily exercised by other professionals in similar circumstances, and with respect to cGMP Products, in accordance with the Product Specifications, Quality Agreement, and Applicable Law.   

  2.2 Services. In addition to the Manufacture and supply of Products hereunder, Supplier shall provide the Services in accordance with SOWs and with the terms and conditions set forth in this Agreement. No SOW will be effective unless signed by authorized representatives of both Parties. Each fully signed SOW will be subject to the terms of this Agreement and will be incorporated herein and form part of this Agreement. 

  (a) Supplier will carry out the activities for Services in accordance with the estimated timeline set forth in such SOW. The Parties acknowledge that certain of the Services set forth in an SOW (including the Initial SOW Plan) will involve performance of activities that are developmental or explorative by nature (the “Explorative Activities”) which, by their nature, are expected to be unpredictable until Supplier has successfully established a standard process or routine for performing such activities. For Services involving activities that are Explorative Activities, [***]. The Parties shall designate in each SOW whether and the extent to which an activity or set of activities governed thereby will include or involve Explorative Activities.  

  (b) Supplier shall promptly inform HMI in writing, after becoming aware, if it is unable to perform the activities under an SOW or if it cannot, or cannot continue to, provide the Services set forth in an SOW or cannot meet the timeline set forth in an SOW. Upon such notice, the Project Managers shall meet to discuss the reasons for Supplier’s inability to perform under such SOW and propose appropriate amendments to the SOW that are reasonably acceptable to both Parties. Any such amendment to an SOW shall be signed by authorized representatives of both Parties. HMI shall have the right to terminate any individual SOW without penalty if at any time during the term of an SOW, Supplier provides such written notice that it is unable to perform the activities under such SOW, including if it is not able to meet the timeline set forth in such SOW; provided that HMI may not exercise such termination right if Supplier’s discontinuation or delay of Services is caused by HMI’s material breach of this Agreement or failure to timely provide HMI Raw Materials. Notwithstanding the foregoing, HMI will pay Supplier for any completed task under a partially performed SOW in accordance with the agreed upon scope and pricing for such task as set forth in the applicable SOW. 

  2.3 Exclusivity and Preferred Supplier. 

  (a) Clinical Supply and Development Exclusivity. 

  (i) During the Term, Supplier shall not Manufacture or supply [***] or provide Services in connection with the [***] to any entity other than HMI or its Affiliates or their licensees. Notwithstanding the foregoing sentence, nothing in this Agreement shall preclude Supplier from Manufacturing any product for any Third Party for so long as Supplier does not use (A) any HMI Intellectual Property Rights or Process or (B) any Contributed NewCo Know-How or Contributed NewCo Patent Rights (as such terms are defined in the License and Patent Management 

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  Agreement) in the Manufacture of such Third-Party product, in each case ((A) and (B)) with respect to any Know-How, but solely to the extent such Know-How is not commonly known to a person skilled in the art in the viral vector industry.

  (ii) HMI shall purchase from Supplier at least (x) [***] of HMI’s actual requirements for clinical supplies of Drug Substance [***] and (y) [***] of HMI’s actual requirements for clinical supplies of Drug Substance [***], it being acknowledged and agreed by the Parties that HMI’s compliance with the minimum purchase obligations in this Section 2.3(a)(ii) shall be determined [***] (as specified below in Section 2.3(a)(v)), taking into account the aggregate purchases made by HMI during the relevant period for all Drug Substance. 

  (iii) During the Initial Term, HMI will pay Supplier (A) [***] covering [***], excluding [***], as directed by the Joint Steering Committee pursuant to Section 2.7(a) and as set forth in the Initial SOW Plan, and (B) at least [***] covering [***]; it being acknowledged and agreed by the Parties that HMI’s compliance with the minimum purchase obligations in this Section 2.3(a)(iii) shall be determined after [***] in accordance with Section 2.3(a)(v). Reasonably in advance of the end of the Initial Term, the Parties shall negotiate with each other in good faith regarding the minimum amount of Services to be purchased by HMI from Supplier during the remainder of the Term after the Initial Term; provided, however, that neither Party shall be obligated to commit to a minimum amount of Services for the remainder of the Term after the Initial Term.

  (iv) The minimum purchase requirements set forth in Section 2.3(a)(ii) shall be adjusted if a Supply Failure occurs as follows: if HMI believes a Supply Failure has occurred at any time after [***], HMI shall provide written notice thereof to Supplier and to the Joint Steering Committee; and if either the Supply Failure cannot be cured or, in the event such Supply Failure can be cured but is not cured within a commercially reasonable period of time under the circumstances, in no case exceeding [***] following Supplier’s receipt of HMI’s written notice of such alleged Supply Failure, then HMI will have the right to [***] Batches of the Drug Substance (or the Drug Product containing such Drug Substance) so affected. 

  (v) HMI agrees to purchase for each of the first [***] of the Initial Term  [***] the following minimum number of Batches of Drug Substance: [***] Batches of Drug Substance ([***]) and [***] Batches of Drug Product for the remaining period of calendar year 2022; and [***] Batches of Drug Substance and [***] Batches of Drug Product for [***] (such minimums and the annual Services minimums set forth in Section 2.3(a)(iii), the initial “Annual Purchase Minimums”).  No later than [***] during the Term (i.e., [***]), HMI shall notify Supplier of its Annual Purchase Minimum for [***] each calendar year thereafter during the Term (in the case this Agreement does not terminate at the end of the calendar year and, in the event of extension of the Initial Term pursuant to Section 6.2, such portion of the calendar year ending on the [***]). Promptly following the end of each calendar year, HMI shall provide Supplier with a written report in reasonable detail setting forth [***] in order for Supplier to determine whether HMI 

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  has met its Drug Substance and Service purchase minimums, as set forth in Sections 2.3(a)(ii) and 2.3(a)(iii), respectively, during the applicable period (the “Demand Based Purchase Minimums”). If within [***] following receipt of such report or if thereafter, Supplier obtains new information indicating that the information contained in such report is inaccurate, Supplier believes that information contained in such report is inaccurate in material respects, it shall so notify HMI in writing. Unless HMI timely provides an updated report reasonably satisfactory to Supplier, Supplier may engage a Third Party auditor reasonably acceptable to HMI to access and review HMI’s records and confirm HMI’s [***] purchased by HMI from Supplier during the applicable period; provided that such auditor may not share with Supplier any Confidential Information of HMI and may only disclose information to Supplier to the extent necessary for Supplier to determine whether HMI has met its applicable Annual Purchase Minimum or Demand Based Purchase Minimum. If, based on the report provided by HMI or based on the findings of such auditor, Supplier reasonably determines that an Annual Purchase Minimum or Demand Based Purchase Minimum shortfall has occurred, then Supplier shall promptly submit an invoice to HMI detailing the shortfall between the number of Batches of the Drug Substance and/or value of Services actually supplied or provided, as applicable, by Supplier and the higher of the applicable Annual Purchase Minimum or Demand Based Purchase Minimum. HMI shall cure such shortfall by paying Supplier within [***] after Supplier’s delivery of such invoice for an amount equal to, (i) with respect to Drug Substance, [***], (ii) with respect to Drug Product, [***], (iii) with respect to Services, [***], and (iv) [***]. Further, in the event of such a shortfall for a calendar year exceeds [***].

  (b) Commercial Supply. 

  (i) No later than [***] (the “Commercial Product”), HMI shall notify Supplier in writing that HMI intends to negotiate the terms of a commercial supply agreement for such Commercial Product, and provide [***]. Supplier shall respond in writing within [***] after receiving such notice from HMI whether Supplier believes it can meet such capacity to produce commercial supplies of such Commercial Product, including any documentation reasonably substantiating Supplier’s capabilities and capacity to produce such commercial supplies, [***]. If Supplier’s written response states that Supplier does not believe it can provide such capacity or capabilities, then Section 2.3(b)(iii) shall apply. 

  (ii) If Supplier’s written response states that Supplier believes it can provide such capacity and capabilities, then the Parties shall exclusively negotiate with each other in good faith for a period of no less than [***] (or such longer period as mutually agreed upon in writing by the Parties) to enter into a commercial supply agreement for such Commercial Product (“Commercial Supply Agreement”). For avoidance of doubt, neither Party shall be obligated to enter into a Commercial Supply Agreement and subject to subsection (iii) below, HMI shall be free to negotiate and enter into with any Third Party a commercial supply agreement for such Commercial Product after the expiration of such exclusive negotiation period.

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  (iii) If Supplier’s written response pursuant to Section 2.3(b)(i) states that Supplier does not believe it has the capacity or capability to Manufacture such Product for commercial use, HMI shall notify OXB in writing that HMI intends to negotiate the terms of a Commercial Supply Agreement for such Commercial Product, and that Supplier has stated it does not have the capacity or capabilities required for commercial supply of such Commercial Product. HMI will provide to OXB then-available information regarding the capacity HMI believes in good faith is required for such commercial supply of such Commercial Product, and any special capabilities that HMI believes are required for commercial supply of such Product. OXB shall respond in writing within [***] after receiving such notice from HMI whether OXB believes it can meet such capacity to produce commercial supplies of such Commercial Product, [***]. If OXB’s written response states that OXB believes it can provide such capacity or capabilities, then HMI shall negotiate exclusively in good faith with OXB for a period of no less than [***] (or such longer period as mutually agreed upon by the HMI and OXB) to enter into a Commercial Supply Agreement for such Commercial Product. If HMI and OXB do not agree on the terms of such Commercial Supply Agreement within such period, HMI shall be entitled to negotiate and enter into a Commercial Supply Agreement with any other Third Party for such Commercial Product without any further obligations owed under this Section 2.3(b). For clarity, this subsection (iii) shall not apply if the Parties commenced negotiations but did not enter into a Commercial Supply Agreement pursuant to subsection (ii).

  (iv) If for a given Product, HMI has complied with all of the provisions of subsection (i) and (ii) above and thereafter enters into a commercial supply arrangement with a Third Party or OXB for commercial supply of such Product, Supplier shall, at HMI’s written request, promptly initiate Technology Transfer for such Product to such Third Party or OXB, as applicable. Such Technology Transfer shall be [***].  

  (v) The Parties agree that the Commercial Supply Agreement may include provisions addressing contingencies in the event that [***].

  (c) Preferred Supplier. HMI acknowledges that Supplier [***] any Third Party supplier in the Manufacture of any Product, provided that [***]. 

  (i) In connection therewith, HMI will provide Supplier with written notice of any future Manufacture and supply opportunities for any Product being considered by HMI, for which HMI intends to seek bids or proposals from Third Parties (“Opportunities”). HMI will at all times have the right to solicit and consider bids and proposals for such Opportunities from Third Parties.  

  (ii) If HMI notifies Supplier in writing of any Opportunities, then Supplier may submit a bid or proposal in respect thereof within [***] after receiving such written notice of an Opportunity from HMI. In the event Supplier makes such submission to HMI, HMI shall take into consideration all relevant terms for such 

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  bids or proposals provided by Supplier, as well as any bids or proposals from Third Parties, [***].  

  (iii) HMI shall have the right to determine, in its sole discretion, whether Supplier’s bid or proposal is competitive with those of Third Parties. If HMI so determines such bid or proposal is competitive, HMI shall reasonably consider awarding such opportunity to Supplier. Nothing in this Section 2.3(c) shall be construed as to prohibit HMI from (A) Manufacturing Product directly; or (B) purchasing Product from other Third Party suppliers. 

  2.4 Manufacturing Changes. Unless otherwise agreed by the Parties in writing, Supplier’s Manufacture of Products will take place at the Facility(ies) and use the same [***], or as specified in an SOW, to the extent [***]. If there is any material change to the Facility(ies) or any change in [***], Processes, [***] relied upon by HMI to Manufacture Products at the Facility(ies) before the Effective Date (“Manufacturing Change”), then (a) Supplier shall reasonably assist HMI with complying with any necessary modifications or variations to regulatory approvals, filings or submissions required under Applicable Law as a result of such changes, (b) Supplier will not commence Manufacturing at a facility other than the Facility(ies) or use different Manufacturing [***], Process, or [***] until HMI has consented in writing to such Manufacturing Change (such consent not to be unreasonably withheld) and HMI and Supplier have received all applicable Licenses and Permits thereto, and (c) any such Manufacturing Change shall be implemented by Supplier in accordance with the Quality Agreement. 

  (i) If a Manufacturing Change is due to Supplier’s request or a Governmental Authority’s requirement to change one or more Facility(ies) which requirement is not specifically or solely relating to any particular Product, [***], unless such Manufacturing Change is related to [***]. 

  (ii) If a Governmental Authority requires any Manufacturing Change with respect to a particular Product or set of Products for use for clinical purposes, then the Parties will meet and discuss in good faith an action plan for such required Manufacturing Change, and Supplier shall be required to implement such required Manufacturing Change and assist HMI with regulatory filings or submissions required under Applicable Law as a result of such required Manufacturing Change, in each case [***]. 

  (iii) Supplier shall make all Manufacturing Changes imposed by a Governmental Authority within a reasonable time after first learning of such requirement. 

  2.5 Subcontracting. Supplier may not subcontract the Manufacture of Products or provision of Services or any portion thereof to a Third Party (other than Permitted Subcontractor) without HMI’s prior written consent, such consent not to be unreasonably withheld, conditioned, or delayed. [***]. Supplier will be responsible for ensuring compliance by such subcontractors with the applicable terms of this Agreement, as if such subcontractors are Supplier hereunder. Each subcontract shall be in writing and shall contain obligations, on the part of the applicable subcontractor, consistent with this Agreement, including with respect to confidentiality and non-use and the assignment of, or the grant of substantially equivalent 

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  rights under, all Intellectual Property Rights that such subcontractor may develop or acquire by reason of work performed under this Agreement. Supplier will conduct, and will cause [***].

  2.6 Key Positions. Supplier acknowledges that the [***] to the Manufacture of Products. Supplier shall submit to HMI for prior review and approval [***], such approval not to be unreasonably withheld, delayed, or conditioned by HMI, provided that such prior review and approval shall not be required for [***]. 

  2.7 Joint Steering Committee. Each Party shall name a mutually agreed upon number of representatives for the joint steering committee (the “Joint Steering Committee,” and each such representative, a “Member”), each of whom shall be a senior employee of the applicable Party and knowledgeable in an appropriate discipline, such as the head of manufacturing/operations for each Party or his or her designee and the relevant discipline experts.

  (a) Within [***] following the Effective Date, the Joint Steering Committee shall mutually agree upon (i) the Key Performance Indicators that will apply to the Manufacturing and supply obligations of Supplier for the applicable Product for the remainder of the calendar year in which the Effective Date occurs, based on [***] with respect to Products [***] prior to the Effective Date, (ii) objective criteria that will serve as the basis for the Key Performance Indicators applicable for each calendar year thereafter, and (iii) (x) the anticipated Services to be covered under the Initial SOW Plan (as defined below), which Services will include Explorative Activities as well as other activities based on equivalent activities that were being performed by HMI as of the Effective Date, and (y) a description of deliverables and specified timelines for such Services, as may be amended from time to time by the Parties (the “Initial SOW Plan”), in each case such Services shall be aligned with the overall agreed-upon budget for Services for such period. Within [***] prior to the end of each calendar year, the Joint Steering Committee shall mutually agree upon the SOWs for Services for the following calendar year.

  (b) From time to time after the Effective Date, the Joint Steering Committee shall (i) establish the Key Performance Indicators that will apply to the Manufacturing and supply obligations of Supplier for any Product that is not a Product as of the Effective Date as promptly as practicable following the [***] becomes available, and (ii) as requested in writing by HMI, discuss and agree upon any improvement plan that is reasonably necessary and appropriate to address any failure to meet or satisfy the Key Performance Indicators as promptly as reasonably practicable (an “Improvement Plan”).  

  (c) In addition to the specific tasks set forth in Sections 2.7(a) and 2.7(b), the Joint Steering Committee shall be responsible for (i) providing a forum for strategic decision-making; (ii) coordinating and reviewing each Party’s performance of its obligations hereunder, including [***], Technology Transfer, and disclosure of HMI-Owned Inventions made by Supplier; (iii) resolving any disputes referred to it by the Project Team; and (iv) making such other determinations as are expressly delegated to it under this Agreement (including establishing the Key Performance Indicators and developing any Improvement Plan). 

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  (d) The Joint Steering Committee shall, at a minimum, consist of at least [***] from each Party. The Joint Steering Committee shall meet in-person, telephonically or by videoconference once per calendar quarter during the Term, or as otherwise mutually agreed by the Parties. The Joint Steering Committee will make decisions by consensus with each Party having [***] vote. If the Joint Steering Committee is unable to reach unanimous decision on a particular matter within a reasonable period (not to exceed [***], unless extended by mutual agreement of the Parties) following the Joint Steering Committee meeting, then the matter will be referred to the Party representatives under Section 11.15, who will use good faith efforts to resolve such matter within [***] after the matter is submitted to them for resolution. 

  2.8 Project Team. 

  (a) Within [***] after the Effective Date, the Parties will establish a project team (“Project Team”), which shall consist of each Party’s project manager who will oversee their respective obligations under this Agreement (each, a “Project Manager”) and such other employees, or, subject to the approval of the other Party, representatives or consultants of a Party as considered necessary to attend by such Party’s Project Manager. Prior to attendance of any Project Team meeting all such employees, representatives and consultants of a Party must be bound by confidentiality obligations at least as protective to the other Party’s Confidential Information as the terms set out in Article 10. The Project Team shall:

  (i) provide a forum for, and facilitate, communications between the Parties with respect to the Manufacture and supply of Products and provision of Services by the Supplier hereunder;

  (ii) have operational responsibility for coordinating the performance of SOWs or Purchase Orders; 

  (iii) discuss and propose, but not approve, the content and budget of SOWs and amendments thereto; and

  (iv) be responsible for initial dispute resolution and if the Project Team is unable to resolve any dispute within [***] after initiating dispute resolution, either Project Manager may refer such dispute to the Joint Steering Committee for resolution.

  (b) The Project Team shall hold meetings as often as the Project Managers agree is necessary during the Term. Project Team meetings may be held in person, or by tele- or video-conference, at such times and places as are agreed to by the Parties. All decisions of the Project Team will be made by consensus of the Project Managers, and any failure to agree will be referred to the Joint Steering Committee for resolution.

  2.9 Limitations on Authority. Notwithstanding any provision to the contrary, neither the Joint Steering Committee nor the Project Team shall have any power (a) to amend or modify the provisions of this Agreement (which may only be amended or modified as provided in Section 11.8), (b) to waive compliance with this Agreement or (c) to make determination as 

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  to whether a Party is in breach of this Agreement; and each Party shall retain the rights, powers and discretion granted to it under this Agreement, and no such rights, powers or discretion shall be delegated to or vested in the Joint Steering Committee or the Project Team. 

  2.10 Technical Support. Both Parties acknowledge that during the Term, Supplier may need temporary technical assistance or support by HMI to facilitate Supplier’s Manufacturing of the Products. [***].

  2.11 Technology Transfer. Upon the occurrence of any of the events set forth under Section 2.11(a), the Joint Steering Committee shall promptly agree upon a plan and timeline for a customary manufacturing technology transfer (“Technology Transfer Plan”) within [***] following the occurrence of the applicable event. Without limiting the foregoing, such an event shall be deemed to have occurred upon delivery of any written notice of termination under Section 6.3. 

  (a) Supplier shall promptly, in accordance with the Technology Transfer Plan, transfer all Know-How under Supplier’s Control (and that is not already in HMI’s possession) that is necessary or actually used by Supplier to Manufacture and supply the Products, for enabling, with respect to events set forth in clauses (i), (ii) and (iv) below, collectively [***] Alternate Manufacturer [***] per Product (for purposes of this Section 2.11(a), an applicable [***] unless otherwise agreed by the Parties in writing), and with respect to event set forth in clauses (iii) and (v), up to [***] Alternate Manufacturers per Product, to Manufacture or have Manufactured the Product(s) by such Alternate Manufacturer (“Technology Transfer”), if one or more of the following events has occurred: [***]. If a Technology Transfer is effected in the case of clause (ii) or (iii) or (v), [***] pursuant to Sections 2.3(a) and 3.1 on an aggregate basis, shall continue to apply; for clarity, if a Technology Transfer is effected in the case of clause (i) with respect to a given Product, the [***] no longer apply to such Product, and the Joint Steering Committee shall promptly discuss and agree on the [***] for the unaffected Products; and, for clarity, if a Technology Transfer is effected in the case of clause (iv), [***]. 

  (b) The Alternate Manufacturer(s), regardless of cause for the Technology Transfer, shall be bound by confidentiality obligations in writing no less stringent than those set forth in ARTICLE 10 and have sufficient process and safeguard in place to protect Supplier’s Confidential Information and manufacturing technologies. 

  (c) Notwithstanding the foregoing, the Technology Transfer Plan shall set forth the maximum number of full time employee (“FTE”) hours that Supplier’s personnel shall be required to provide in the performance of such transfer activities. [***]. 

  (d) To effect a Technology Transfer, Supplier shall transfer to HMI, to the extent not already in HMI’s possession, copies of any physical embodiment of any and all such Know-How (including without limitation quality control documents, quality assurance documents and testing and release documents, equipment specifications and detailed drawings for equipment), that are necessary for or used by Supplier to Manufacture the Product(s). Such transfer shall be achieved by the delivery of material documents, to the extent such Know-How is embodied in such documents, and to the extent that such Know-How is not fully embodied in such documents, to effect the foregoing, Supplier shall make available its and its Affiliates’ 

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  appropriately qualified employees and agents, and appropriately qualified employees and agents of its Third Party suppliers/vendors, to the extent Supplier has the right to make such Third Party supplier/vendor employees and agents available, in each case who have sufficient knowledge of such Know-How in addition to that embodied in documents available to HMI, for interviews and discussions with, demonstrations to and training of HMI’s employees at Supplier’s Facility(ies). If HMI engages an Alternate Manufacturer to Manufacture a Product, subject to the Technology Transfer Plan, Supplier shall use commercially reasonable efforts to effect the transfer of Know-How applicable to such Product to such Alternate Manufacturer. Supplier shall reasonably respond to HMI’s questions via telephone or e-mail raised from time to time with respect to the Know-How and its use thereof that is necessary to effect the intent of the Technology Transfer. 

  2.12 Alternate Manufacturer. Prior to selecting a Third Party as an Alternate Manufacturer, HMI will confer with Supplier and reasonably consider Supplier’s comments with respect thereto, including with respect to any concerns regarding protection of Know-How to be transferred to such Third Party for manufacturing the relevant Product(s). Following a Technology Transfer to the applicable Alternate Manufacturer(s), HMI shall not, and shall not permit the applicable Alternate Manufacturer(s) to, further transfer to any other CMO the transferred Know-How so as to enable such other CMO to Manufacture any applicable Product(s), provided that the foregoing restriction on transfer of Know-How shall not apply to CMO(s) that HMI may engage to Manufacture a Commercial Product pursuant to Section 2.3(b) or Section 2.3(c).

  ARTICLE 3
PURCHASE TERMS - DELIVERY - QUALITY CONTROL

  3.1 Forecasts. 

  (a) On the Effective Date, HMI shall provide a [***] forecast to Supplier for [***] consistent with the Annual Purchase Minimums and the Demand Based Purchase Minimums in a form substantially similar to the exemplary forecast in Exhibit B, specifying the [***] forecasted number of Batches of Drug Substance and number of Batches of Drug Product and the [***] forecast for Services, subject to and consistent with the Initial SOW Plan and the Joint Steering Committee’s initial direction for Services to be provided prior to final agreement on the Initial SOW Plan.  

  (b) No later than [***], HMI shall provide a [***] forecast for the next [***] (the “[***] Forecast”), provided that such [***] forecast shall not in any event include any time period beyond [***] and shall not be binding or otherwise relied upon by either Party beyond the expiration of the Term. The [***] of each [***] Forecast (except for Services that are forecasted to first commence in [***]) shall be binding on both Parties (the “Binding Forecast”), and the [***] of each [***] Forecast will be consistent with the Annual Purchase Minimums and the Demand Based Minimums or up to [***] higher than the Annual Purchase Minimums (or in the case of Drug Product Batches, [***] higher than what was forecast for such [***] in the [***]) in which case Supplier would use commercially reasonable efforts to meet such excess demand. To calculate the foregoing deviation, any forecasted number of Batches of Drug Substance and number of Batches of 

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  Drug Product shall be based on whole Batches (as no partial Batches would be supplied), and if such updated [***] Forecast would exceed the [***] upper limit due to the requirement that HMI purchase whole Batches, the Supplier would use commercially reasonable efforts to supply such additional whole Batch if requested by HMI. 

  (c) If HMI’s Purchase Order or SOW calls for a lesser number of Batches of Drug Substance or Drug Product or value of Services, as applicable, than set forth in the Binding Forecast, then Supplier shall use commercially reasonable efforts to utilize the unused capacity that would have been used to Manufacture Products or provide Services, as applicable, to Manufacture other products or provide services for other customers of Supplier, and HMI shall only be liable to Supplier for, [***] that are actually incurred by Supplier in reliance on the Binding Forecast but are not used in the Manufacture of products or performance of services to HMI or other customers.

  3.2 Purchase Orders and SOWs. 

  (a) All orders for Products must be received in writing and include (i) the number of Batches of the Drug Substance, (ii) the number of Batches of the Drug Product, (iii) for each Batch of Drug Product ordered, the number and identity of Batches of the applicable Drug Substance to be used, (iv) delivery terms, (v) type and amount of HMI Raw Materials to be provided to Supplier, and (vi) the applicable Drug Substance Batch Price and Filling Price, as applicable (each a “Purchase Order”). The first Purchase Order shall be submitted within [***] after the Effective Date and cover the Products to be supplied to HMI over the first [***] of the first [***] Forecast. All subsequent Purchase Orders shall be sent by HMI in writing to Supplier monthly at least [***] before the date upon which Manufacture of the applicable Batch of Drug Substance or Drug Product is expected to be initiated. Any terms or conditions in a Purchase Order that conflicts with this Agreement shall be null and void. Supplier shall confirm in writing within [***] after receipt of each Purchase Order that is consistent with Section 3.1 its acceptance of such Purchase Order, which shall be then considered a firm order (“Firm Order”). [***] period, the Purchase Order shall be deemed accepted by Supplier and thereby a Firm Order, provided that it is consistent with Section 3.1.  

  (b) Supplier shall provide the Services in accordance with the Initial SOW Plan and individual SOWs. Any Services not covered by the Initial SOW Plan will be performed under individual SOWs. For individual SOWs, upon HMI’s request, Supplier will prepare and provide HMI with a draft SOW for review and comment, and such SOW will be binding if the Parties agree upon and sign the SOW, provided that Supplier will not be obligated to begin providing Services under any such SOW any sooner than [***] after the last signature date of such SOW. In the event a Party wishes to amend an SOW, such Party will identify the work under such SOW it wishes to be amended, added or terminated in writing and Supplier will provide a draft change order to HMI for review. Once the Parties have agreed on the draft change order, such change order will be signed by both Parties and the applicable SOW shall be deemed amended in accordance with such change order. 

  3.3 Orders. Supplier will accept and supply the number of Batches of Drug Substance and/or Drug Product ordered by HMI in Purchase Orders (and which will therefore be Firm Orders) that comply with the number of Batches of Drug Substance and the number of Batches 

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  of Drug Product, as applicable, stated in the applicable Binding Forecast and other terms of this Agreement. With respect to a Drug Substance or a Drug Product, Supplier [***] additional number of Batches of such Drug Substance or Drug Product that exceeds no more than [***] of the number of Batches of such Drug Substance or Drug Product stated in the applicable Binding Forecast for the applicable period; provided that Supplier then has available resources and capacity to supply such excess number of Batches of Drug Substance or Drug Product. To the extent HMI’s Purchase Order exceeds such forecasted number of Batches of the applicable Drug Substance or Drug Product by more than [***] for the applicable period, Supplier shall have no obligation to accept the Purchase Order for such excess number of Batches of such Drug Substance or Drug Product. It is understood that Supplier shall not be obliged to deliver such excess number of Batches of Drug Substance or Drug Product until Supplier has agreed to do so in writing by its acceptance of Purchase Orders specifying such excess number of Batches of Drug Substance or Drug Product. Subject to the foregoing, Supplier shall meet the delivery dates and the number of Batches of the applicable Drug Substance or Drug Product indicated in HMI’s Firm Order. Subject to Section 3.8(b), if any circumstances occur that could reasonably result in any delivery delay or variation in the number of Batches of any Drug Substance or Drug Product supplied, Supplier shall immediately inform HMI thereof in sufficient detail for HMI to assess the likelihood that such delivery delay or variation in the number of Batches of Drug Substance or Drug Product will [***]. The Joint Steering Committee will discuss and identify appropriate measures to address the shortage and/or delay and Supplier will [***]. Notwithstanding the foregoing two sentences, Supplier [***] the number of Batches of Drug Substance and/or Drug Product order in Purchase Orders in the event the potential shortage and/or delay is the result of HMI’s failure to provide the HMI Raw Materials necessary for the initiation or completion of the applicable Purchase Order in accordance with Section 3.4. If HMI reasonably anticipates a failure to timely provide HMI Raw Materials necessary for the initiation or completion of a Purchase Order, it shall promptly notify Supplier via the Project Team, and the Parties shall discuss in good faith and agree on appropriate solutions, and if the solutions mutually agreed upon require Supplier to obtain alternative sources of HMI Raw Materials, [***].

  3.4 Raw Materials. 

  (a) On a Product-by-Product, Purchase Order-by-Purchase Order and/or SOW-by-SOW basis, HMI shall provide to Supplier certain HMI Raw Materials that are necessary for the Manufacture of Products or the performance of Services. In the event where HMI specifies in a Purchase Order or an SOW that a Product shall be made or that certain Services shall be performed using certain HMI Raw Materials (as applicable), HMI will deliver the amount of HMI Raw Materials that is reasonably expected to be necessary for the initiation of such Purchase Order or SOW at least (a) [***] before the expected production start date for the relevant Product Batch or (b) [***] before the expected start date for the relevant Services, and HMI shall further deliver any remaining amount of the HMI Raw Materials that is necessary for the completion of such Purchase Order (including in connection with any replacement of Products in accordance with the terms hereof) or such SOW. HMI shall be responsible for sourcing and qualifying the suppliers for all HMI Raw Materials, and HMI will provide Supplier with access to written confirmation of release for each item of the HMI Raw Materials, and upon Supplier’s request in writing, 

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  Certificates of Analysis if applicable. [***]. Supplier may not use the HMI Raw Materials for any purpose other than to Manufacture Products and to perform Services for HMI. 

  (b) Any raw material necessary for the Manufacture of Product or the performance of Services that is not provided by HMI to Supplier as HMI Raw Material is the responsibility of Supplier.   Unless otherwise specified herein, all Supplier-sourced materials and consumables shall be [***].  It is acknowledged that pursuant to the Contribution Agreement, HMI shall have contributed certain assets, including certain raw materials necessary for the Manufacture of Product, to Supplier at or prior to the Effective Date.  With respect to up to [***] Batches (i.e., [***]) of Drug Substance of Named HMI Product(s) supplied hereunder, if the raw materials contributed by HMI under the Contribution Agreement are of sufficient quantity and suitable for the Manufacture of such Batches of Drug Substance of Named HMI Products, [***]. For purposes of this Section 3.4(b), raw materials are “suitable” if as of the time of initiation of the Manufacture of the applicable Batch of Drug Substance, such raw materials conform in all material respects to the applicable specifications and quality standards for each item of such raw materials set forth in the Quality Agreement (as applicable), and with cGMP.  For clarity, for any subsequent Batches of Drug Substance after [***], (i.e., [***]) supplied hereunder, [***] in accordance with Section 5.1 regardless of Supplier’s utilization of any amount of suitable raw materials or other assets contributed to Supplier pursuant to the Contribution Agreement.

  (c) All HMI Raw Materials will be provided [***] to Supplier. 

  (d) For clarity, the Drug Substance Batch Price and the Filling Price shall exclude [***]. 

  (e) It is understood and agreed that Supplier-sourced materials may require a longer time period to acquire or procure the supply thereof and accordingly will be purchased by Supplier based on the applicable [***] Forecast; and in the event the number of Batches of any Drug Substance or Drug Product set forth in a Binding Forecast is lower than the number of Batches for such Drug Substance or Drug Product set forth in the applicable [***] Forecast that was first submitted by HMI for the applicable period, HMI shall reimburse Supplier for the non-cancellable portion of the Supplier-Sourced Material [***] directly attributable to such deviation; provided that Supplier shall use its commercially reasonable efforts to utilize or store for later use the excessive portion of the Supplier-sourced materials to mitigate such costs to HMI. 

  3.5 Delivery. 

  (a) All Batches of Drug Product shall be delivered by Supplier [***] or delivered to the applicable warehouse or storage location at the Facility or such other location as is agreed by the Parties in writing and set forth in the applicable Purchase Order. [***]. Each delivery of the Drug Product shall be accompanied by a Certificate of Analysis and any other documentation set forth in Section 4.5 of the Quality Agreement. Risk of loss or damage to Drug Product shall pass to HMI [***]. 

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  (b) A Batch of Drug Substance shall be deemed to have been delivered by Supplier [***] or delivered to the applicable warehouse or storage location at the Facility or such other location as is agreed by the Parties in writing and set forth in the applicable Purchase Order upon the Manufacturer’s Release thereof. [***] risk of loss or damage shall pass from Supplier to HMI [***].

  (c) The Project Team shall discuss and determine the logistics and procedures for the Manufacturer’s Release of Drug Substance and the delivery of Drug Product for the period when the manufacturing Facility is physically located in the same building as HMI.

  3.6 Supply Capacity. [***] pursuant to this Agreement at [***], as necessary, to Manufacture Products for HMI in accordance with the [***] and to provide Services as set forth in the [***]. The Joint Steering Committee will periodically discuss [***] Manufacture of Products and provision of Services for HMI.

  3.7 Storage.  During the Term, HMI is entitled to request the Supplier to store an inventory of up to [***] supply of each Product in the form designated by HMI (e.g., as Drug Substance or Drug Product, on a Product-by-Product basis), [***], based on the then-current Binding Forecast, on a first-expiry first-out basis and if so requested, the Parties will negotiate in good faith and enter into an SOW covering such storage. Subject to the applicable SOW, [***] of the applicable Drug Substance or delivery of the applicable Drug Product and Supplier will provide to HMI, upon written request, an inventory status report setting forth the number of Batches of the Drug Substance and Drug Product and dating of each Batch of such Drug Substance and Drug Product stored by Supplier.

  3.8 Supply Shortage.

  (a) In the event the Joint Steering Committee has mutually agreed upon an Improvement Plan with respect to a Product pursuant to Section 2.7(b), Supplier shall use its commercially reasonable efforts to implement such Improvement Plan. 

  (b) The Parties acknowledge and agree that the yield on any Batch of Product may vary based on the nature of the Product and Manufacturing technology used therefor. With respect to a Product, promptly after the Manufacture of the [***] Batch of Drug Substance or the [***] Batch of Drug Product, in each case at the Facility whether Manufactured by HMI prior to the Effective Date or by Supplier after the Effective Date, the Parties shall discuss (via the Joint Steering Committee) in good faith [***] by the Joint Steering Committee [***].

  (i) [***]. 

  (ii) [***]. 

  (iii) [***]. 

  (c) [***]. If Supplier experiences capacity constraints for any reason, including due to a Force Majeure Event or shortage of a Supplier-sourced materials, Supplier shall [***].

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  ARTICLE 4
QUALITY

  4.1 Quality Agreement. The Parties shall enter into a Quality Agreement on or before the closing date under the Contribution Agreement.

  4.2 Non-Conformance with Product Specifications and Defects.

  (a) Without limiting Sections 2.3(a)(iv) and 2.11, [***]. 

  (b) HMI shall notify Supplier in writing of any Patent Defects in a Batch of cGMP Product (including by way of inspection or examination of the Certificate of Analysis, batch records or any other documentation required to be provided with each delivery of the Products) within [***] of delivery of the relevant Batch of cGMP Product.

  (c) HMI shall notify Supplier of any Latent Defects in a Batch of cGMP Product within [***] after becoming aware of such Latent Defect.

  (d) Subject to Section 4.2(e), (i) solely with respect to Defect(s) [***], Supplier shall replace the Defective Product(s) [***] as promptly as practical and in any case initiate the replacement within [***] after notice is provided under Section 4.2(b), and if Supplier does not, or is unable to initiate a replacement within such period, then [***]; and (ii) if the Defect(s) are not caused by [***], Supplier shall replace the Defective Product(s) upon HMI’s request and [***] within a timeline reasonably agreed to between the Parties; provided that Supplier shall have the capacity to Manufacture such replacement.

  (e) In the event of an alleged Defect, Supplier will investigate the cause for such Defect in accordance with the Quality Agreement. If Supplier disputes that there is a Defect or that the Defect [***] based on its investigation, the Parties shall investigate the dispute in accordance with the Quality Agreement, including any quality assurance and compliance activities that have been established and mutually agreed upon by the Parties to detect or measure parameters of such Defect(s). A copy of the investigation report delivered in accordance with the Quality Agreement (if applicable) shall be provided to the Project Team concurrently. If within [***] following the conclusion of such investigation, the Parties through the Project Team are unable to reach an agreement regarding (i) whether there is a Defect or (ii) the cause of the Defect, the matter may be referred by either Party to the Joint Steering Committee in accordance with Section 2.7.  If the Joint Steering Committee is not able to resolve such dispute within [***], then, the Parties shall engage [***] to determine whether there is Defect and/or the cause of Defect, if applicable, [***]. The determination of [***] shall be final and binding on both Parties. [***]. If [***] determines that the Batch (or portion thereof) of cGMP Product is [***] Supplier shall replace the Defective Products as promptly as practical and in any case initiate the replacement within [***] of [***] determination, and if Supplier is unable to, or does not, initiate a replacement within such period, then [***]. HMI will be responsible for the destruction of the relevant Batch(es) (or portions thereof) of Products found to be Defective that are in HMI’s possession.

  (f) If Supplier has [***] implement such remediation plan in a timely manner.

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  ARTICLE 5
PRICES – INVOICING - PAYMENTS

  5.1 Drug Substance Supply Price. With respect to a Drug Substance, the price for each cGMP Batch of such Drug Substance will be the sum of [***] (collectively, the “Drug Substance Supply Price”). The Parties agree to negotiate in good faith a reasonable discount to the Drug Substance Batch Price for engineering/reference Batches of Drug Substance that are not intended to be or required to be cGMP compliant.

  5.2 Drug Product Filling Price. With respect to a Drug Product, the price for each Batch of such Drug Product will be the sum of [***]. For clarity, the Filling Price for a Drug Product shall not include the cost of the Drug Substance that is used or consumed in the Drug Product Manufacturing process.

  5.3 Supply Price Determination and Adjustments. 

  (a) Prior to HMI’s submission of the first Purchase Order for a Drug Substance that is an Other HMI Product, HMI shall provide reasonable advance notice to Supplier with description of the applicable Process and materials required for the Manufacture of such Drug Substance in sufficient detail for Supplier to determine the applicable Drug Substance Batch Price. Subject to Section 5.3(c), Supplier shall, at its sole discretion, determine and notify HMI of the Drug Substance Batch Price for such Drug Substance; provided that such Drug Substance Batch Price shall be [***]. For avoidance of doubt, neither Party is obligated under this Agreement to accept the price proposed by the other Party for any Other HMI Product.

  (b) No later than [***] prior to the beginning of each calendar year after the Effective Date, Supplier shall be permitted, on an annual basis, to increase the Drug Substance Batch Prices or Filling Price by written notice to HMI, which price increase shall become effective as of [***]; provided that such year-to-year increase in Drug Substance Batch Price for a Drug Substance or the Filling Price for a Drug Product shall not exceed [***]; provided further, that such price increase shall not apply to any Firm Orders, whether outstanding or fulfilled as of the effective date of such increase. 

  (c) Notwithstanding the foregoing, Supplier shall review the prices for Products charged to HMI as soon as [***]. 

  5.4 Development Services Prices. 

  (a) The prices for the Services for calendar year 2022 shall be the Services fees set out in the Initial SOW Plan, which shall be paid in equal monthly installments. The prices for all Services set out in individual SOWs will be paid based on [***], in each case incurred in connection with the performance of the applicable Services.

  (b) For calendar year 2023, the FTE Rate for the Services to be provided shall be [***] (which is calculated based on an hourly rate of [***] and [***] per year per FTE). No later than [***] prior to the beginning of calendar year 2024 and each calendar year thereafter, Supplier shall be permitted, on an annual basis, to increase the then-current FTE 

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  Rate by written notice to HMI, which price increase shall become effective as of January 1 of such calendar year; provided that such year-to-year increase in FTE Rate shall not exceed [***]. 

  (c) Notwithstanding the foregoing, the FTE Rate paid by HMI for the Services [***]. 

  5.5 Invoices. For all payments due under this Agreement, Supplier shall provide HMI with an invoice for the amount due.

  (a) Unless otherwise agreed by the Parties, (i) during the term of the Initial SOW Plan, HMI shall pay the [***] Services fees set forth in Section 5.4(a) on a monthly basis, upon receipt of the applicable invoice; and (ii) with respect to any Services performed under an individual SOW, in accordance with the payment schedule set out in the applicable SOW.

  (b) The Drug Substance Batch Price for each Batch of the Drug Substance Manufactured under this Agreement shall be due as follows: (i) [***]; (ii) [***]; and (iii) [***].

  (c) The Filling Price for each Batch of the Drug Product Manufactured under this Agreement shall be due as follows: (i) [***]; and (ii) [***].

  (d) Supplier shall issue invoices for any fees and charges when due under Sections 5.5(a) through 5.5(c), and shall issue monthly invoices to HMI for any other cost and additional charges due under this Agreement [***] payments under Sections 5.5(a) through 5.5(c). Invoices shall be sent to the HMI invoice mailbox as outlined in the Purchase Order or SOW. Each invoice shall set forth in reasonable detail the amounts payable by HMI under this Agreement and contain the following information, as applicable: Supplier’s name, associated Purchase Order or SOW reference number, HMI contact name, the applicable Drug Substance Batch Price, Filling Price or Service fees, [***] in connection therewith. HMI shall promptly notify the Supplier if it determines that any invoice or related document is inaccurate or incorrectly submitted to HMI, but in any event no later than the payment due date of the invoice. HMI may withhold from an invoice any portion of the invoiced amount that is disputed in good faith, but shall pay the undisputed portion before the payment deadline for such invoice. Other than disputes resolved under Section 4.2, the Parties shall seek to resolve any invoice disputes expeditiously and in good faith in accordance with the dispute resolution provisions set forth in Section 11.15. Any payment by HMI of an invoice is not an acceptance of the terms of said invoice to the extent it is inconsistent with the terms and conditions of this Agreement, or any nonconforming element of the related Batch of Product.

  5.6 Payment. Except for any amounts disputed by HMI in good faith, Supplier’s accurate and correctly submitted invoices will be payable within [***] following HMI’s receipt of Supplier’s invoice. Any payment by HMI will not be deemed acceptance of the Products or waive HMI’s right to inspect the delivered Products. HMI shall make all payments under this 

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  Agreement in United States dollars by check, wire transfer or automated clearing house in accordance with the instructions as stated on the applicable invoice.

  5.7 [***].

  5.8 Late Payments. Any late payments due hereunder shall bear interest at an annual rate equal to the [***] of (a) [***] and (b) the highest rate permitted by Applicable Law, in each case, calculated based on the number of days such payment is delinquent from the date originally due as provided in Section 5.6, [***]. 

  5.9 No Setoff. All payments required to be made by either Party hereunder shall be calculated without reference to any set off or counterclaim and shall be made free and clear of and without any deduction for or on account of any set off or counterclaim.

  5.10 Taxes. All amounts due to Supplier under this Agreement: 

  (a) are exclusive of any value added taxes, goods and services taxes, sales taxes, consumption taxes and other similar indirect taxes imposed with respect to, or as a result of, such amounts due to Supplier under this Agreement (“Indirect Taxes”). HMI (or its assignee) shall be responsible for the payment of any such Indirect Taxes and shall pay to the Supplier for remittance by the Supplier to the appropriate taxing authority (or, if required by Applicable Law, directly to the appropriate taxing authority) the amount of any such Indirect Taxes. Supplier shall provide to HMI all customary receipts for payment of such Indirect Taxes and reasonably cooperate with HMI in making applications for and securing any available exemptions or reductions of Indirect Taxes reasonably available;

  (b) shall be made free and clear of, and without, any deduction or withholding on account of taxes, except to the extent such taxes are required to be withheld under Applicable Law. If Applicable Law requires withholding by HMI (or its assignee) with respect to any payments made to Supplier under this Agreement, such taxes shall be deducted by HMI (or its assignee, if applicable) as required by Applicable Law and timely remitted to the proper tax authorities, and if HMI changes its domicile to a country where withholding tax is required by Applicable Law or if HMI assigns this Agreement to any Person that resides in a country where withholding tax is required by Applicable Law, then HMI or its assignee, as applicable, or their respective assignee, shall make an additional payment to Supplier such that Supplier receives, after deduction and withholding of taxes from such payment, including any additional amount, an amount equal to the amount it would have received absent any such deduction and withholding. HMI (or its assignee) shall furnish official receipts of payment of any withholding tax to Supplier as evidence of its remittance of any amounts required to be withheld in respect of any payments (including additional amounts payable under this Section 5.10(b)). The Parties shall cooperate to ensure that any withholding taxes imposed are reduced to the extent legally permissible under the provisions of any relevant tax treaty or other Applicable Law, which cooperation shall include providing assistance with the completion of any required forms; and

  (c) Supplier shall provide to HMI as properly executed, correct and complete Internal Revenue Service Form W-9 promptly after the Effective Date.

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  ARTICLE 6
TERM AND TERMINATION

  6.1 Initial Term. This Agreement shall be effective from the Effective Date, and shall, unless terminated earlier under the provisions of Article 6, continue until [***].

  6.2 Term Extension. The Initial Term may be renewed for [***] if HMI provides written notice of renewal to Supplier at least [***] prior to the expiration date of the Initial Term (the Initial Term and if applicable, such additional [***] term, the “Term”). If the Initial Term is renewed pursuant to this Section 6.2, the terms and conditions of this Agreement during the extended Term will be the same as the terms in effect during the Initial Term, including HMI’s forecast obligations pursuant to Sections 2.3(a) and 3.1, respectively, unless otherwise agreed by Parties in writing; provided, however, that notwithstanding the foregoing, such same terms shall not include any obligation by HMI to commit to any Annual Purchase Minimums, Demand Based Purchase Minimums, or [***] Forecast, in each case, to the extent covering any period beyond expiration of such additional [***] term. 

  6.3 Termination.

  (a) After the Initial Term, HMI may, at its option, terminate this Agreement in its entirety or on a Product-by-Product basis at any time and for any reason by giving prior written Notice of termination to Supplier. Termination will be effective [***] after the date Supplier receives such termination Notice. If such termination would become effective prior to the expiration of the Term, HMI shall pay to Supplier [***]. 

  (b) Either Party may terminate this Agreement in its entirety for cause by providing written termination Notice to the other Party:

  (i) subject to Section 4.2, if the other Party is in material breach of its representation, warranty or covenant under this Agreement and either the breach cannot be cured or, if the breach can be cured, it is not cured by the breaching Party within a commercially reasonable period of time under the circumstances, in no case exceeding [***] following breaching Party’s receipt of the non-breaching’s written notice of such breach, provided that if (1) such breach cannot be cured within the [***] period, (2) the breaching Party provides a notice to the non-breaching Party indicating the same, (3) delivers a plan to cure such breach to the non-breaching Party, and (4) cures the breach complained of within [***] following the expiration of the [***] period, then this Agreement shall continue in full force and effect; or

  (ii) if the other Party becomes insolvent or is generally unable to pay, or fails to pay, its debts as they become due; files or has filed against it, a petition for voluntary or involuntary bankruptcy or otherwise becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law; makes or seeks to make a general assignment for the benefit of its creditors; or applies for or has appointed a receiver, trustee, custodian or similar agent appointed by order of any court 

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  of competent jurisdiction to take charge of or sell any material portion of its property or business, in each case above, that is not discharged within [***] thereafter.

  Any termination under this Section 6.3(b) will be effective on the other Party’s receipt of the first Party’s written termination Notice or such later date (if any) set forth in such termination Notice. 

  6.4 Change of Control of Supplier or HMI. In the event of Change of Control of either Party, the terms of this Agreement shall continue with both Parties being obligated to perform under the original terms of this Agreement. If modification of this Agreement is desired by either Party after the Change of Control, the Parties shall discuss in good faith to come to mutually agreed upon modified terms. If a written amendment is not reached by the Parties, the original terms of this Agreement shall continue to govern. 

  6.5 Effect of Expiration or Termination. Immediately upon the effective date of termination:

  (a) Subject to performing any necessary wind-down activities Supplier shall promptly terminate all performance under this Agreement and under any outstanding Purchase Orders and SOWs unless directed otherwise by HMI, provided that HMI shall pay to Supplier (i) Supplier’s costs actually incurred towards partially completed Services or unfinished Products or that will be incurred by Supplier during the remainder of the Term and are not cancellable, (ii) reasonable costs associated with necessary wind-down activities, and (iii) only in the event of a termination by Supplier pursuant to Section 6.3(b), [***]. 

  (b) Supplier shall transfer title and deliver to HMI all Products Manufactured prior to the effective date of termination that were made in accordance with the Product Specifications, Purchase Order, the Quality Agreement and Applicable Law.

  (c) Expiration or termination of this Agreement will not affect any rights or obligations of the Parties that come into effect as of or prior to termination of this Agreement or expiration of the Term; or otherwise survive the expiration or early termination of this Agreement, and were incurred by the Parties prior to such expiration or early termination.

  (d) The licenses granted by HMI to Supplier under Section 8.2(a) shall terminate, and the licenses granted by Supplier to HMI under Section 8.2(b) shall become perpetual. 

  (e) Each Party shall:

  (i) return to the other Party all documents and tangible materials (and any copies) containing, reflecting, incorporating or based on the other Party’s Confidential Information;

  (ii) permanently erase all of the other Party’s Confidential Information from its computer systems, except for copies that are 

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  maintained as archive copies on its disaster recovery and/or information technology backup systems or otherwise required to comply with cGMP or Applicable Law. Each Party shall destroy any such copies upon the normal expiration of its backup files; and

  (iii) upon the other Party’s written request, certify in writing to such other Party that it has complied with the requirements of this Section 6.5(e).

  (f) Supplier shall be responsible for all cleanup and remediation of the Facility(ies) and removal and decommissioning of all materials and equipment therein used for Manufacturing Products, except for liabilities that are not assumed by Supplier pursuant to the Contribution Agreement, which shall remain as HMI’s liabilities as between the Parties.

  (g) Except as otherwise provided herein, neither Party, will be liable to the other Party for any damages of any kind (whether direct or indirect) incurred by the other Party solely arising out of the expiration or earlier termination of this Agreement. However, termination of this Agreement will not constitute a waiver of any of the terminating Party’s rights or remedies under this Agreement, at law, in equity or otherwise.

  6.6 Survival. In addition to the survivability of certain provisions of this Agreement as expressly set forth herein, the following provisions shall survive in the event of expiration or termination of this Agreement for any reason: Sections 4.2(a) through (e), 5.5, 5.6, 5.7, 5.8, 5.9, 5.10, 6.3, 6.5, 6.6, 7.3, 7.5, 7.6, 8.1, 8.2, 9.1, 9.2, 9.3, 9.4, 9.5(g), 9.6, 9.7, 9.8, 9.9, 9.10, and 9.11 and Articles 1, 8, 10 and 11 and such other provisions hereof as are required for the interpretation or enforcement of those Sections, and any other provisions that, as apparent from their terms in the context of this Agreement, are intended to survive termination or expiration of this Agreement.

  ARTICLE 7
REGULATORY OBLIGATIONS - AUDITS

  7.1 Subject to the terms of the Quality Agreement, Supplier shall Manufacture the Products in accordance with cGMP and all Applicable Law.

  7.2 Supplier undertakes that the equipment and portion of the Facility(ies) under Supplier’s ownership used to Manufacture the cGMP Products will meet the requirements of the Quality Agreement, cGMP appropriate to the phase of Product development and of all Applicable Law, except for liabilities that are not assumed by Supplier pursuant to the Contribution Agreement, which shall remain as HMI’s liabilities.

  7.3 Supplier shall provide access to Governmental Authorities and cooperate fully with such authorities for any matter involving the Products supplied to HMI. Such access will occur upon reasonable advance notice during normal business hours unless otherwise required by Governmental Authorities. Supplier shall also [***] provide such access to and cooperation with the Governmental Authorities [***] with the Governmental Authorities, [***]; provided that Supplier shall not be in breach of this Agreement or the Quality Agreement in the event that such [***]. Notwithstanding the foregoing two sentences, [***]. Supplier shall 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  immediately notify HMI upon receipt of notice from a Governmental Authority for an inspection of Supplier’s Facilities where the Manufacturing of Products or Services are being performed, or in the event of an unannounced inspection, Supplier shall provide immediate notice if possible and permissible to the extent such inspection relates to the Manufacturing of Products or performance of Services. If permitted by the Governmental Authority, one Designee from HMI shall be permitted to be present on site where a Governmental Authority requests such attendance or where the audit or inspection is specific to a Product or Services but such Designee shall not participate in such audit or inspection. If Supplier receives any request by a Governmental Authority that requires a written response regarding the Products or Services, Supplier shall provide HMI a copy of such notice within [***] of Supplier’s receipt of the notice. Supplier shall provide HMI a draft of the response prior to the response being submitted to the Governmental Authority so as to provide HMI with a reasonable period of time in which to review and comment on the response, which comments Supplier, in good faith, shall consider and incorporate into the response to the extent such comments are appropriate and specific to a Product or Services and in accordance with the Quality Agreement. 

  7.4 Upon HMI’s prior request and upon at least [***] prior Notice and not more than [***], Supplier shall allow a maximum of [***] auditing Designees of HMI to inspect, during normal business hours, its facilities where the Products are Manufactured in order to observe operations related to Manufacture and testing thereof subject to Supplier’s standard operating procedures, and to review such of Supplier’s records relating to the Manufacture, safety, quality and regulatory control, release, storage, shipping and delivery of the Products as are relevant to confirm Supplier’s compliance with the Quality Agreement, [***].  From time to time during the Term, Supplier shall also allow a Designee of HMI (or person in plant), to observe operations related to Manufacture and testing of the Product at mutually agreed times; provided that HMI shall provide reasonable advance notice to Supplier together with the stated purpose of the observation.  HMI’s Designee shall not have access to clean rooms during Manufacture but may view the Manufacture of the Product through video feed, viewing gallery or such other means of observation as Supplier may make available from time to time at the Facility.  Any Designee attending the Facility pursuant this Section 7.4 may at Supplier’s sole discretion be required to enter into an appropriate confidentiality agreement with Supplier.  Notwithstanding the foregoing, to the extent any material breach of the Quality Agreement is found by HMI, Supplier shall [***] prior written notice. In the event of a critical quality issue identified by Supplier or a Governmental Authority, Supplier will notify HMI in accordance with the Quality Agreement, and all forecasts (including, as applicable, Binding Forecast and each [***] Forecast) and outstanding Purchase Orders shall be appropriately reduced to omit quantities of the affected Product during the pendency of any such critical issue until the full resolution thereof. 

  7.5 Supplier shall have in place systems and procedures to facilitate rapid recalls related to the Products and shall inform HMI where Supplier believes that such a recall of Products or product made with Products is necessary. In such circumstances, the Parties shall consult with each other as to what decisions or actions may be required. The cost of such recall shall be borne (i) by Supplier in the event that such recall has arisen or resulted from any breach or negligence or willful misconduct or violation of Applicable Law of Supplier and (ii) by HMI in all other cases. HMI shall retain exclusive responsibility for all decisions and actions with 

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  respect to any complaint, recall, market withdrawal or other corrective action concerning the HMI’s finished products unless otherwise appropriate or required by the relevant Governmental Authority. 

  7.6 If HMI is required to submit to a Governmental Authority information or data relating to a Product Manufactured by Supplier or to Services rendered by Supplier, for any reason including to seek or maintain marketing approval or to respond to an agency request for information, Supplier will promptly cooperate with HMI and provide to HMI all documentation, data and other information in Supplier’s possession as HMI may reasonably require and request for such submission or response to Governmental Authority to the extent in Supplier’s possession, custody or control. The cost of providing such information and cooperation shall be specified in an SOW and shall be borne by HMI.

  ARTICLE 8
INTELLECTUAL PROPERTY

  8.1 Ownership. HMI shall remain the sole owner of all right, title and interest in and to, or licensee of, as applicable, all HMI Intellectual Property Rights existing as of the Effective Date and shall solely own all HMI Intellectual Property Rights arising thereafter during the Term, and no right, title or interest therein is transferred or granted to Supplier except as expressly set forth in Section 8.2. Supplier shall remain the sole owner of all right, title and interest in and to, or licensee of, as applicable, all Supplier Intellectual Property Rights existing as of the Effective Date and shall solely own all Supplier Intellectual Property Rights arising thereafter during the Term, and no right, title or interest therein is transferred or granted to HMI except as expressly set forth in Section 8.2. Subject to the License and Patent Management Agreement, as between the Parties, HMI shall solely own all rights, title and interest in and to HMI-Owned Inventions and Supplier shall solely own all rights, title and interest in and to Supplier-Owned Inventions. Each Party shall cause its employees, consultants, agents, or independent contractors to so assign to such Party such person’s entire right, title and interest in and to the foregoing, and all intellectual property rights therein, and to take all reasonable additional actions and execute such agreements, instruments, and documents as may be reasonably required, as is necessary to enable such Party to fully effect the ownership of the foregoing, and intellectual property rights therein, as provided in this Section 8.1.

  8.2 Licenses.

  (a) Subject to the terms and conditions of this Agreement, HMI hereby grants to Supplier a non-exclusive, non-transferable, non-sublicensable (except as set forth in Section 2.5), royalty-free, limited license to use HMI Intellectual Property Rights solely for the purpose of Manufacturing the Products and performing the Services pursuant to the terms and conditions of this Agreement. 

  (b) Subject to the terms and conditions of this Agreement, Supplier hereby grants to HMI [***].

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  8.3 Inventions. Supplier shall disclose promptly to HMI, in writing, any and all HMI-Owned Inventions conceived or created by or on behalf of Supplier. Supplier hereby assigns to HMI all of Supplier’s right, title and interest in and to HMI-Owned Inventions without any additional consideration. At HMI’s request and expense during and after the Term, Supplier shall provide HMI with reasonable assistance to perfect HMI’s ownership interest in HMI-Owned Inventions and in obtaining, securing, maintaining, and enforcing patents and other Intellectual Property Rights covering such HMI-Owned Inventions. HMI shall disclose promptly to Supplier, in writing, any and all Supplier-Owned Inventions conceived or created by or on behalf of HMI. HMI hereby assigns to Supplier all of HMI’s right, title and interest in and to Supplier-Owned Inventions without any additional consideration. At Supplier’s request and expense during and after the Term, HMI shall provide Supplier with reasonable assistance to perfect Supplier’s ownership interest in Supplier-Owned Inventions and in obtaining, securing, maintaining, and enforcing patents and other Intellectual Property Rights covering such Supplier-Owned Inventions. Each Party shall cause its employees, consultants, agents, or independent contractors to so assign to such Party such person’s entire right, title and interest in and to the foregoing, and all intellectual property rights therein, and to take all reasonable additional actions and execute such agreements, instruments, and documents as may be reasonably required, as is necessary to enable such Party to fully effect the ownership of the foregoing, and intellectual property rights therein, as provided in this Section 8.3.

  8.4 Relationship with the License and Patent Management Agreement. Notwithstanding the foregoing, the Parties acknowledge and agree that in the event certain HMI-Owned Inventions and Supplier-Owned Inventions constitute Jointly Managed Patents under the License and Patent Management Agreement, the ownership of such HMI-Owned Inventions and Supplier-Owned Inventions shall be governed by Section 8.3 hereunder except for [***], and such Jointly Managed Patents shall be prosecuted, maintained, enforced and otherwise managed pursuant to Articles 3, 4, 5, 6, 7, 8, and 9 of the License and Patent Management Agreement.

  ARTICLE 9
REPRESENTATIONS, WARRANTIES, INDEMNIFICATION AND LIABILITY

  9.1 Mutual Representations and Warranties. HMI and Supplier each represents and warrants as follows:

  (a) it has all requisite corporate power and authority to enter into this Agreement and each Purchase Order and SOW and to carry out the transactions contemplated hereby and thereby;

  (b) the execution, delivery and performance of this Agreement and each Purchase Order and SOW and the consummation of the transactions contemplated hereby and thereby have been duly authorized by all requisite corporate action on the part of such Party;

  (c) this Agreement has been duly executed and delivered by such Party and (assuming the due authorization, execution and delivery hereof by the other party) is a valid 

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  and binding obligation of such Party, enforceable against it in accordance with its terms; and

  (d) its entry into this Agreement does not violate or constitute a breach of any of its existing contractual obligations with Third Parties as of the Effective Date.

  9.2 Product Warranty. Assuming the accuracy of the representations and warranties in Section 9.3, Supplier warrants to HMI that:

  (a) on the date of delivery in accordance with Section 3.5, each of the cGMP Product Manufactured and supplied hereunder will:

  (i) conform in all material respects to the Product Specifications;

  (ii) conform with the quality standards in the Quality Agreement; and

  (iii) have been Manufactured in compliance with all Applicable Law, including without limitation 21 U.S.C. §§ 351(a)(2)(B); and

  (b) each Batch of Product will be conveyed by Supplier to HMI with good title, free and clear of all liens, security interests, and other encumbrances; 

  (for each Product, the “Product Warranty”).

  9.3 Raw Materials Warranty. HMI warrants to Supplier that:

  (a) on the date of delivery of HMI Raw Materials at the Facility(ies), the HMI Raw Materials will:

  (i) conform in all material respects to the HMI Raw Materials specifications; and

  (ii) conform with the quality standards for each item of HMI Raw Materials in the Quality Agreement, as applicable; and

  (b) each HMI Raw Material will be conveyed by HMI to Supplier with good title, free and clear of all liens, security interests, and other encumbrances;

  (the “HMI Raw Materials Warranty”).

  9.4 Additional Terms. The Products Warranty and the HMI Raw Materials Warranty (a) inures to the benefit of HMI or Supplier, as applicable, and their successors and permitted assigns, and (b) may not be limited or disclaimed by HMI or Supplier, as applicable. HMI’s approval of Supplier supplied materials, consumables, Product Specifications or similar requirements will not be construed to relieve Supplier of any Product Warranties. Supplier’s approval of HMI Raw Materials will not be construed to relieve HMI of any HMI Raw Materials Warranties.

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  9.5 Compliance. Supplier represents, warrants and covenants to HMI as follows:

  (a) To Supplier’s knowledge, all employees and individual consultants and contractors engaged by Supplier or its Affiliates in the Manufacture of the Products and the performance of the Services (collectively, “Supplier Personnel”) are, and will continue to be, qualified and have, and will continue to have, sufficient technical expertise by directly applicable training, experience and supervision to perform Supplier’s obligations under this Agreement; 

  (b) Supplier and its Affiliates are licensed and permitted as necessary to Manufacture the Products and perform the Services, including performing cGMP Manufacturing, under all Applicable Law;

  (c) all performance of Services by Supplier, its Affiliates, and Supplier Personnel will be performed in accordance with: (i) all Applicable Law; (ii) the terms and conditions of this Agreement, the Quality Agreement (if applicable); (iii) generally prevailing industry standards; and (iv) HMI’s written instructions, including without limitation SOWs;

  (d) Supplier will [***];

  (e) none of Supplier, its Affiliates, or to Supplier’s knowledge, any Supplier Personnel has been debarred, disqualified or banned by any governmental or Governmental Authority or is subject to a debarment proceeding, and Supplier and its Affiliates will not knowingly employ or contract with any person or entity that has been so debarred, disqualified or banned to perform any Manufacturing of Products or Services;

  (f) To Supplier’s knowledge, all Supplier Personnel are, and will continue to be, under binding obligation (i) to assign to Supplier all inventions and Intellectual Property Rights therein that they develop or create in connection with this Agreement to Supplier and (ii) of confidentiality to Supplier that are substantially similar to or more stringent than the confidentiality obligations of Supplier to HMI under this Agreement;

  (g) Supplier will maintain all records of Manufacture Products and performance of the Services under this Agreement and archive such records, if applicable, in accordance with cGMP, and Applicable Law, but in no case for less than a period of [***] following completion of a Purchase Order or SOW (completion period shall not include the period of any long-term stability study conducted by Supplier); and

  (h) Supplier will [***] in providing Services, to the extent such equipment or materials are not provided or specified by HMI, in each case, under this Agreement.

  9.6 Additional Representations and Warrants by HMI. HMI represents, warrants and covenants to Supplier as follows:

  (a) To its knowledge, as of the Effective Date, there are no patents, trade secrets or other intellectual property or other proprietary rights of any Third Party related to the Manufacture of Products that would be violated, infringed, misappropriated or misused by Supplier’s performance of this Agreement; and

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  (b) It and its Affiliates shall comply with all Applicable Law in its performance under this Agreement. 

  9.7 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT (INCLUDING THE PRODUCT WARRANTY), NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED (AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT), INCLUDING WITH RESPECT TO ANY PATENTS OR KNOW-HOW, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE, AND NON-INFRINGEMENT OF ANY THIRD PARTY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHT. 

  9.8 Indemnification.

  (a) Subject to the terms and conditions of this Agreement, Supplier shall indemnify, defend and hold harmless HMI, its Affiliates, and their respective successors and assigns, and each of their respective Representatives (collectively, “HMI Indemnified Parties”) against any and all losses, damages, liabilities, costs, or expenses, including reasonable attorneys’ fees (collectively, “Losses”) in connection with suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”) arising out of or resulting from:

  (i) a breach of any of Supplier’s representations, warranties, obligations or covenants set forth in this Agreement (including the Product Warranty);

  (ii) any bodily injury, the death of any Person, or damage to real or tangible personal property caused by the negligent acts or omissions of Supplier or any of its Representatives;

  (iii) any grossly negligent or more culpable act or omission of Supplier or any of its Representatives (including any recklessness or willful misconduct) in connection with Supplier’s performance under this Agreement;

  (iv) [***] or 

  (v) any failure by Supplier or any of its Representatives to comply with any Applicable Law.

  Notwithstanding the foregoing, Supplier’s obligations under this Section 9.8(a) to indemnify the HMI Indemnified Parties will not apply to the extent any Losses of a HMI Indemnified Party arises out of any of the bases for indemnification described in Section 9.8(b).

  (b) Subject to the terms and conditions of this Agreement, HMI shall indemnify, defend and hold harmless Supplier and its Affiliates, and their respective successors and assigns, and each of their respective Representatives (collectively, “Supplier Indemnified 

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  Parties”) against any and all Losses in connection with Third Party Claims arising out of or resulting from:

  (i) breach of any of HMI’s representations, warranties, or covenants set forth in this Agreement;

  (ii) any grossly negligent or more culpable act or omission of HMI or any of its Representatives (including any recklessness or willful misconduct) in connection with HMI’s performance under this Agreement;

  (iii) any bodily injury, the death of any Person, or damage to real or tangible personal property caused by the negligent acts or omissions of HMI or any of its Representatives; 

  (iv) use of the Product Manufactured pursuant to this Agreement including in any clinical trials; 

  (v) the Manufacture of Products or provision of Services under HMI’s instructions or directions under this Agreement;

  (vi) any actual or alleged infringement, misappropriation or violation of any Third Party intellectual property by (A) use of the tangible materials that are provided by HMI (including HMI Raw Materials), (B) the practice of a Process specified by HMI to use in the Manufacture of Products, or (C) the conduct of any clinical trials utilizing the Product Manufactured pursuant to this Agreement, except to the extent arising from the use of any compositions or methods developed by Supplier and used to supply such Product that are not provided or specified by HMI; or

  (vii) any failure by HMI or any of its Representatives to comply with any Applicable Law, including in the event HMI’s instructions or directions to Supplier with respect to Manufacture of Products or Services provided violate Applicable Law.

  Notwithstanding the foregoing, HMI’s obligations under this Section 9.8(b) to indemnify the Supplier Indemnified Parties will not apply to the extent any Losses of a Supplier Indemnified Party arises out of any of the bases for indemnification described in Section 9.8(a).

  9.9 Exceptions and Limitations on Indemnification. Notwithstanding anything to the contrary in this Agreement, an indemnifying Party is not obligated to indemnify or defend any indemnified Party against any Losses resulting directly from indemnified Party’s:

  (a) gross negligence or recklessness or willful misconduct; or

  (b) bad faith failure to materially comply with any of its obligations set forth in this Agreement.

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  9.10 Indemnification Procedures. A Supplier Indemnified Party or a HMI Indemnified Party entitled to indemnification pursuant to either Section 9.8(a) or Section 9.8(b) will hereinafter be referred to as an “Indemnitee.” A Party obligated to indemnify an Indemnitee hereunder will hereinafter be referred to as an “Indemnitor.”  In the event an Indemnitee is seeking indemnification under either Section 9.8(a) or Section 9.8(b), the Indemnitee will inform the Indemnitor of a Third Party Claim as soon as reasonably practicable after it receives notice of the Third Party Claim, it being understood and agreed that the failure by an Indemnitee to give notice of a Third Party Claim as provided in this Section 9.10 will not relieve the Indemnitor of its indemnification obligation under this Agreement except and only to the extent that such Indemnitor is actually prejudiced as a result of such failure to give notice. The Indemnitee will permit the Indemnitor to assume direction and control of the defense of the Third Party Claim (including, subject to this Section 9.10, the right to settle the Third Party Claim solely for monetary consideration), and, at the Indemnitor’s expense, will co-operate as reasonably requested in the defense of the Third Party Claim. The Indemnitee will have the right to retain its own counsel at its own expense; provided, that, if the Indemnitor assumes control of such defense and the Indemnitee reasonably concludes, based on advice from counsel, that the Indemnitor and the Indemnitee have conflicting interests with respect to such Third Party Claim, the Indemnitor will be responsible for the reasonable fees and expenses of counsel to the Indemnitee solely in connection therewith. The Indemnitor may not settle such Third Party Claim, or otherwise consent to an adverse judgment in such Third Party Claim, which would subject the Indemnitee to an injunction or if such settlement or judgment would materially diminish or limit or otherwise adversely affect the rights, activities or financial interests of the Indemnitee, without the express written consent of the Indemnitee. The Indemnitor will not be liable for any settlement or other disposition of a Loss by an Indemnitee that is reached without the written consent of the Indemnitor, and Indemnitees shall not admit any liability with respect to, or settle, compromise or discharge, any Third Party Claim without the prior written consent of the Indemnitor, such consent not to be unreasonably withheld. In the event that it is ultimately determined that the Indemnitor is not obligated to indemnify, defend or hold harmless the Indemnitee from and against the Third Party Claim, the Indemnitee will reimburse the Indemnitor for all costs and expenses (including attorneys’ fees and costs of suit) and any Third Party Claims incurred by the Indemnitor in its defense of the Third Party Claim.

  9.11 Limitations on Liability.

  EXCEPT IN THE CASE OF [***], (A) IN NO EVENT SHALL EITHER PARTY OR ITS REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR ENHANCED DAMAGES ARISING OUT OF OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (1) WHETHER SUCH DAMAGES WERE FORESEEABLE, (2) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR (3) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE; AND (B) SUPPLIER’S TOTAL LIABILITY 

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  UNDER THIS AGREEMENT SHALL NOT EXCEED [***] (I) [***] AND (II) THE TOTAL OF THE AMOUNTS PAID AND AMOUNTS PAYABLE BY HMI TO SUPPLIER OVER THE [***] IMMEDIATELY PRIOR TO THE OCCURRENCE OF THE EVENT GIVING RISE TO THE LIABILITY, PROVIDED THAT FOR CLAIMS ARISING DURING THE [***] OF THE TERM, THE CAP SHALL BE NO LESS THAN THE DOLLAR AMOUNT THAT EQUALS [***]. 

  9.12 Insurance. Each Party shall take all necessary steps, at its own cost and its own behalf to properly and adequately insure, with a reputable insurance company as far as reasonably possible, its entire legal liability to any Third Party which might be incurred, directly or indirectly, as a consequence of its activity relating to this Agreement. Supplier shall promptly inform HMI of any significant liability claim made by a Third Party or threat of a liability claim by a Third Party in connection with the Products and shall examine them in close consultation with HMI. For avoidance of doubt, such insurance will not create a limit to either Party’s liability hereunder.

  ARTICLE 10
CONFIDENTIALITY

  10.1 Confidential Information. From time to time during the Term, either Party (as the “Disclosing Party”) may disclose or make available to the other Party (as the “Receiving Party”) information about its business affairs, Products (including Product Specifications and HMI Raw Materials), and services (including any forecasts), confidential information and materials comprising or, relating to Intellectual Property Rights, Products, HMI’s SOPs and quality management system, Third Party confidential information and other sensitive or proprietary information. Such information, whether provided orally or in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as “confidential” constitutes “Confidential Information” hereunder. Confidential Information does not include information that at the time of disclosure and as established by contemporaneous documentary evidence:

  (a) is or becomes generally available to and known by the public other than as a result of, directly or indirectly, any breach of this Section 10.1 by the Receiving Party or any of its representatives;

  (b) is or becomes available to the Receiving Party on a non-confidential basis from a Third Party source, provided that such Third Party is not and was not prohibited from disclosing such Confidential Information;

  (c) was known by or in the possession of the Receiving Party or its representatives prior to being disclosed by or on behalf of the Disclosing Party; provided that information known to representatives of Supplier who were representatives of HMI prior to the consummation of the transactions contemplated by the Contribution Agreement shall be treated as Confidential Information of HMI; provided further, that Know-How assigned by HMI to Supplier pursuant to the Contribution Agreement shall be Confidential Information of Supplier; or

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  (d) was or is independently developed by the Receiving Party without reference to or use of, in whole or in part, any of the Disclosing Party’s Confidential Information.

  Notwithstanding anything herein to the contrary, any HMI-Owned Inventions shall be Confidential Information of HMI and any Supplier-Owned Inventions shall be Confidential Information of Supplier. 

  10.2 Protection of Confidential Information. The Receiving Party shall, for [***] from receipt or disclosure of such Confidential Information:

  (a) protect and safeguard the confidentiality of the Disclosing Party’s Confidential Information with at least the same degree of care as the Receiving Party would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care;

  (b) not use the Disclosing Party’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and 

  (c) not disclose any such Confidential Information to any Person, except to the Receiving Party’s representatives who need to know the Confidential Information to assist the Receiving Party, or act on its behalf, to exercise its rights or perform its obligations under this Agreement, and then only if each such representative is otherwise bound by obligations of confidentiality with respect to such information.

  The Receiving Party shall be responsible for any breach of this Article 10 caused by any of its representatives.

  10.3 Permitted Disclosure. Receiving Party may disclose Disclosing Party’s Confidential Information to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:

  (a) in order to comply with Applicable Law (including any securities law or regulation or the rules of a securities exchange or as a requirement in filing for an International Nonproprietary Name (INN) or the like but excluding any regulatory inspections) or with a legal or administrative proceeding, or in connection with prosecuting or defending litigation;

  (b) in connection with filings and other necessary disclosures and communications to Governmental Authorities and obligations pursuant to this Agreement; and 

  (c) in connection with exercising its rights hereunder, to its Affiliates, potential and future collaborators (including sublicensees), advisors, or independent contractors; permitted acquirers or assignees; and investment bankers, investors and lenders;

  provided, however, that (i) with respect to Sections 10.3(a) and 10.3(b), where reasonably possible, Receiving Party will notify Disclosing Party of Receiving Party’s intent to make any disclosure pursuant thereto sufficiently prior to making such disclosure so as to allow 

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  Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information to be disclosed; and (ii) with respect to Section 10.3(c), each of those named people and entities are bound by restrictions on use and disclosure consistent with Article 10 (other than advisors, investment bankers, investors and lenders, which must be bound prior to disclosure by commercially reasonable obligations of confidentiality) and in any event, no disclosure of Know-How relating to the Manufacture of the Products shall be permitted. Notwithstanding the foregoing, unless consented to by HMI and Supplier in advance or as required by Law (in which case the Party required to make such disclosure will consult with the other Party a reasonable time prior to making such disclosure and will consider in good faith any comments made by the other Party to such disclosure), the Parties shall keep this Agreement strictly confidential and may not make any disclosure of this Agreement to any person or individual other than to their Affiliates. If either Party or any of its Affiliates, based on the advice of their counsel, determines that this Agreement must be publicly filed with a Governmental Authority, then such Party or its applicable Affiliate, prior to making such filing, shall provide the other Party and its counsel with a redacted version of this Agreement that it intends to file, and will consider in good faith any comments provided by the other Party or its counsel and use commercially reasonable efforts to ensure the confidential treatment by such Governmental Authority of those provisions specified by the other Party or its counsel for redaction and confidentiality.

  ARTICLE 11
MISCELLANEOUS

  11.1 Further Assurances. Upon a Party’s reasonable request, the other Party shall, at its sole cost and expense, execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.

  11.2 Relationship of the Parties. Without prejudice to the Contribution Agreement, the Transition Services Agreement or any other agreement between the Parties, the relationship between Supplier and HMI is solely that of vendor and vendee and they are independent contracting parties. Nothing in this Agreement creates any agency, joint venture, partnership or other form of joint enterprise, employment or fiduciary relationship between the Parties. Neither Party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.

  11.3 Entire Agreement. This Agreement, including and together with any related exhibits, schedules, the Quality Agreement, SOW, and any Purchase Orders, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein and therein and shall collectively constitute the Agreement, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter. In case of a conflict between:

  (a) the provisions of any schedule, Purchase Order, exhibit, or SOW and the provisions of the main body of this Agreement, the provisions of the main body of this Agreement shall prevail; 

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  (b) the provisions of this Agreement and the provisions of the Contribution Agreement, unless otherwise expressly stated or the context otherwise requires, the provisions of the Contribution Agreement shall prevail; 

  (c) the provisions of this Agreement and the provisions of the Transition Services Agreement, unless otherwise expressly stated or the context otherwise requires, the provisions of this Agreement shall prevail; and

  (d) the provisions of the Quality Agreement and the provisions of this Agreement, the provisions of this Agreement shall prevail, except that with respect to matters related to quality, the Quality Agreement shall prevail.

  11.4 Notices. All notices, requests, consents, claims, demands, waivers and other communications under this Agreement (each, a “Notice”) must be in writing and addressed to the other Party at its address set forth below (or to such other address that the receiving Party may designate from time to time in accordance with this Section 11.4). All Notices must be delivered by personal delivery, nationally recognized overnight courier or certified or registered mail (in each case, return receipt requested, postage prepaid). Notwithstanding the foregoing, notice by email (with confirmation of transmission) will satisfy the requirements of this Section 11.4 if acknowledged by the intended recipient upon receipt by replying to the original email message (except for any automated reply), such acknowledgement shall not be unreasonably withheld, delayed or conditioned. Except as otherwise provided in this Agreement, a Notice is effective only (a) on receipt by the receiving Party, and (b) if the Party giving the Notice has complied with the requirements of this Section 11.4.

  41

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  		
	Notice to Supplier:
	Roadrunner Solutions LLC
One Patriots Park
Bedford, MA 01730

	 
	Attention: Chief Executive Officer
Email: [***]

	 
	 
with a copy (which shall not constitute notice) to: [***]
 
with a copy (which shall not constitute notice) to: [***]
 

	Notice to HMI:
	HMI
One Patriots Park
Bedford, MA 01730
Attention: General Counsel
Email: [***]
with a copy (which shall not constitute notice) to: [***]

	Notice to OXB:
	[Oxford Biomedica UK Limited
Windrush Court, Transport Way
Oxford, OX4 6LT, UK]
Attention: [***]
Email: [***]
 

  11.5 Interpretation. For purposes of this Agreement: (a) the words “include,” “includes” and “including” is deemed to be followed by the words “without limitation”; (b) the word “or” is not exclusive; (c) the words “herein,” “hereof,” “hereby,” “hereto” and “hereunder” refer to this Agreement as a whole; (d) words denoting the singular have a comparable meaning when used in the plural, and vice-versa; and (e) words denoting any gender include all genders. Unless the context otherwise requires, references in this Agreement: (x) to sections, exhibits, schedules, attachments, and appendices mean the sections of, and exhibits, schedules, attachments and appendices attached to, this Agreement; (y) to an agreement, instrument or other document means such agreement, instrument or other document as amended, supplemented and modified from time to time to the extent permitted by the provisions thereof; and (z) to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder. The Parties drafted this Agreement without regard to any presumption or rule requiring construction or interpretation against the Party drafting an instrument or causing any instrument to be drafted. The exhibits, schedules, attachments, and appendices referred to herein are an integral part of this Agreement to the same extent as if they were set forth verbatim herein.

  11.6 Headings. The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  11.7 Severability. If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability does not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal or unenforceable, the Parties shall negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.

  11.8 Amendment and Modification. No amendment to this Agreement is effective unless it is in writing, identified as an amendment to this Agreement and signed by an authorized representative of each Party.

  11.9 Waiver. No waiver under this Agreement is effective unless it is in writing, identified as a waiver to this Agreement and signed by an authorized representative of the Party waiving its right. Any waiver authorized on one occasion is effective only in that instance and only for the purpose stated, and does not operate as a waiver on any future occasion. None of the following constitutes a waiver or estoppel of any right, remedy, power, privilege or condition arising from this Agreement: any failure or delay in exercising any right, remedy, power or privilege or in enforcing any condition under this Agreement; or any act, omission or course of dealing between the Parties.

  11.10 Cumulative Remedies. All rights and remedies provided in this Agreement are cumulative and not exclusive, and the exercise by either Party of any right or remedy does not preclude the exercise of any other rights or remedies that may now or subsequently be available at law, in equity, by statute, in any other agreement between the Parties or otherwise.

  11.11 Equitable Remedies. Each Party acknowledges and agrees that (a) a breach or threatened breach by such Party of any of its obligations under Article 9 or 10 would give rise to irreparable harm to the other Party for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by such Party of any such obligations, the other Party shall, in addition to any and all other rights and remedies that may be available to such Party at law, at equity or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Each Party agrees that such Party will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this Section 11.11.

  11.12 Assignment. Neither Party may assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably delayed or withheld; provided, however, that (a) Supplier may assign its rights and obligations under this Agreement without HMI’s prior written consent in connection with an assignment to an Affiliate or a Third Party acquirer of all or substantially all of the Transferred Assets constituting the Facility(ies) and the business of the Facility(ies) 

  43

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  and (b) HMI shall have right to assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of Supplier to its Affiliates or to any Third Party who acquires all or substantially all of the assets to which this Agreement relates. Any purported assignment or delegation in violation of this Section 11.12 is null and void ab initio. No assignment, delegation or transfer will relieve Supplier of the performance of any accrued obligation that Supplier may then have under this Agreement.

  11.13 Successors and Assigns. This Agreement is binding on and inures to the benefit of the Parties and their respective permitted successors and permitted assigns.

  11.14 No Third Party Beneficiaries. Except as expressly set forth in the second sentence of this Section 11.14, this Agreement benefits solely the Parties to this Agreement and their respective permitted successors and permitted assigns and nothing in this Agreement, express or implied, confers on any other Person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement. The Parties hereby designate each indemnified Person as a Third Party beneficiary of Section 9.8.

  11.15 Dispute Resolution. Except as provided in Section 11.11, any dispute, controversy or claim arising out of or relating to this Agreement, or the breach, termination or invalidity hereof (each, a “Dispute”), shall be submitted for negotiation and resolution to the designated representative of Supplier (or to such other person of equivalent or superior position designated by Supplier in a written Notice to HMI) and an officer of HMI (or to such other person of equivalent or superior position designated by HMI in a written Notice to Supplier), by delivery of written Notice (each, a “Dispute Notice”) from either of the Parties to the other Party. Such persons shall negotiate in good faith to resolve the Dispute. If the Parties are unable to resolve any Dispute within [***] after delivery of the applicable Dispute Notice, either Party may file suit in a court of competent jurisdiction in accordance with the provisions of Section 11.16 and Section 11.17 hereunder.

  11.16 Governing Law. This Agreement, including all exhibits, schedules, attachments and appendices attached hereto and thereto, and all matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the Laws of the State of Delaware, without regard to the conflict of Laws provisions thereof. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement.

  11.17 Choice of Forum. Each Party irrevocably and unconditionally agrees that it shall not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments and appendices attached hereto and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims, in any forum other than the United States District Court for the District of Massachusetts or, if such court does not have subject-matter jurisdiction, the courts of the State of Massachusetts, and any appellate court from any thereof. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation or proceeding only in the United States District Court for the District of Massachusetts or, if such court does not have subject-matter jurisdiction, the courts of the State of Massachusetts. Each Party agrees that a final 

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  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  judgment in any such action, litigation or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Law.

  11.18 Waiver of Jury Trial. Each Party acknowledges and agrees that any controversy that may arise under this Agreement, including any exhibits, schedules, attachments, and appendices attached to this Agreement, is likely to involve complicated and difficult issues and, therefore, each such Party irrevocably and unconditionally waives any right it may have to a trial by jury in respect of any legal action arising out of or relating to this Agreement, including any exhibits, schedules, attachments, and appendices attached to this Agreement, or the transactions contemplated hereby. Each Party certifies and acknowledges that (a) no representative of the other Party has represented, expressly or otherwise, that such other Party would not seek to enforce the foregoing waiver in the event of a legal action, (b) such Party has considered the implications of this waiver, (c) such Party makes this waiver voluntarily, and (d) such Party has been induced to enter into this Agreement by, among other things, the mutual waivers and certifications in this Section 11.18.

  11.19 Counterparts. This Agreement may be executed in counterparts, each of which is deemed an original, but all of which together is deemed to be one and the same agreement. A signed copy of this Agreement delivered by e-mail or other means of electronic transmission (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) is deemed to have the same legal effect as delivery of an original signed copy of this Agreement, if the party sending such e-mail or other means of electronic transmission has received express confirmation that the recipient party received the copy of this Agreement (not merely an automatic email reply).

  11.20 Force Majeure. Any delay or failure of either Party to perform its obligations under this Agreement will be excused to the extent that the delay or failure was caused directly by an event beyond such Party’s reasonable control, without such Party’s fault or negligence (which events may include natural disasters, epidemics and pandemics, embargoes, explosions, riots, wars or acts of terrorism) (each, a “Force Majeure Event”). For the avoidance of doubt, the COVID-19 pandemic, including any variants of COVID-19 or any government restrictions or regulations relating thereto, will constitute a Force Majeure Event to the extent it causes the applicable delay or failure. Supplier’s financial inability to perform, changes in costs that are within its control, or Supplier’s legal actions or contract disputes will not excuse performance by Supplier under this Section 11.20. Supplier shall give HMI prompt written Notice of any event or circumstance that is reasonably likely to result in a Force Majeure Event and the anticipated duration of such Force Majeure Event. Supplier shall use all reasonable efforts to end the Force Majeure Event, ensure that the effects of any Force Majeure Event are minimized and resume full performance under this Agreement. During any Force Majeure Event, HMI may, at its option (a) [***]. The rights granted to Supplier with respect to excused delays under this Section 11.20 are intended to limit Supplier’s rights under theories of force majeure, commercial impracticability, impracticability or impossibility of performance, or failure of presupposed conditions or otherwise. The Parties acknowledge and agree that HMI’s [***].

  11.21 No Public Announcements or Trademark Use. Unless expressly permitted under this Agreement or the Contribution Agreement, neither Party shall (a) make any statement (whether oral or in writing) in any press release, external advertising, marketing or promotion 

  45

  

  [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential.

   

  materials regarding the subject matter of this Agreement, the other Party or its business unless (i) it has received the express written consent of the other Party, or (ii) it is required to do so by Law or under the rules of any stock exchange to which it is subject, or (b) use any of the other Party’s Trademarks without the prior written consent of the other Party.

  [Signature page follows] 

  46

  

   

  IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date first set forth above.

  		
	 
	HOMOLOGY MEDICINES, INC.
 

	 
	By: /s/ Arthur Tzianabos
Name:  Arthur O. Tzianabos
Title:    President and Chief Executive Officer 
 

	 
	ROADRUNNER SOLUTIONS LLC
 

	 
	By: /s/ Tim Kelly
Name:  Tim Kelly
Title:    Chief Executive Officer

	 
	 
Solely for purposes of Section 2.3(b)(iii)
OXFORD BIOMEDICA UK LIMITED
 

	 
	By: /s/ Stuart Paynter
Name: Stuart Paynter
Title: Chief Financial Officer

   

   

  [Signature Page for Manufacturing and Supply Agreement]

   

  

    

  Schedule 1.65

  Named HMI Products

  [***]

   

   

   

   

  

   

  Schedule 2.6

  Key Positions* 

       [***]

   

   

   

   

   

  

   

  Exhibit A

  Sample SOW

  [***]

   

   

   

  

   

  Exhibit B

  Initial [***] Forecast

   

  [***]

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