INTERNATIONAL JOINT VENTURES FOR RESEARCH AND DEVELOPMENT

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M110 October 16, 2017; 9:30 a.m. 10:45 a.m. INTERNATIONAL JOINT VENTURES FOR RESEARCH AND DEVELOPMENT Structuring and Negotiating International Joint Ventures for Research Involving U.S. Activities J. Michael Slocum, Esquire; Slocum & Boddie, P.C.; Alexandria, VA USA Mir Asghar Ali Khan, Senior Manager; Aga Khan University, Karachi, PK

Learning Objectives Learn about joint venture structures, regulatory issues, preliminary agreements, and related agreements Outline of a typical joint venture agreement (parties, governance, financing, disputes, intellectual property issues, separation and termination) Discuss additional issues, such as government approvals, taxes, due diligence, expatriates and political risk insurance 2

Structures International joint ventures come in a multitude of sizes and shapes Partnership/LLC/LLP Corporation Contractual (non equity) Either be a co ownership model or simply a contract between the parties whereby they retain all their own assets and agree as to their separate rights and obligations Partnering" arrangements, strategic alliances and outsourcing services arrangements 3

Scope/Purpose of the JV What activities does the JV intend to do or refrain from doing Corporate opportunity issues Existing and potential future conflicts with each party's non JV businesses Scope of non compete covenants and the confidentiality obligations of each party Any core technology or other intellectual property ("IP") either to be transferred to the JV or to be granted by the parties to the JV (continued) 4

Scope/Purpose of the JV (2) Other inter corporate arrangements that either will be required for the JV to operate or that are required to make the investment in the JV meet the business case Due diligence Generally no less than that required for an acquisition and in many cases more thorough 5

Regulatory Issues Current and any anticipated regulatory issues, including: Foreign ownership Antitrust Export control issues Labor and employment issues Restrictions, registration and other issues related to ownership and control of the JV, its assets, the operation of its proposed business, and IP resulting from research (continued) 6

Regulatory Issues (2) Dilution, exit and liquidation rights Government requirements for accounting treatment in JV Government and contractual obligations to third parties (bank and other) Approvals required for the implementation and ongoing operation of the JV, including non compete or confidentiality obligations 7

Tax Considerations Flow through, independent taxation or consolidation with parent(s) Income, VAT, property tax issues Non profit status issues Taxation of IP Off shoring potential Credits against the partners' home country tax liability Repatriation 8

Deal Structure Pure patent licensing with little or no collaboration Collaborative deals Co commercialization Certain aspects of discovery research relegated to R&D entity; trials, regulatory and commercialization were left to commercial partner Sale and marketing of a product under a single trademark, with cooperation in commercializing Co marketing (independent simultaneous sale and marketing by parties of a defined product under different trademarks) (continued) 9

Deal Structure (2) Co development Discovery research and/or product development activities, with a continuing role by each party Joint ventures New entity to develop and market a drug Equity acquisitions Ultimate collaboration in terms of shared goals 10

Beginning the Process: Letter of Intent/Term Sheet Binding or non binding If binding: Ensure all key provisions covered may be difficult to introduce new business points after signing Unless and until replaced by a definitive agreement agreed to by the parties within a specified time no material changes without further approval Consider use of arbitration if parties cannot agree upon definitive agreement or if there is a dispute as to interpretation of letter of intent Consider whether to include covenant to negotiate in good faith definitive agreement (continued) 11

Beginning the Process: Letter of Intent/Term Sheet (2) Appropriate approvals received before signing Board and stockholder approval Regulatory approval Third party contractual consents, etc. If approvals not obtained in advance, letter of intent could provide that it becomes effective once the necessary conditions precedent have been met Non circumvention/no deal shopping issues Consider whether to leave confidentiality agreement in place or replace it with confidentiality obligations in letter of intent (continued) 12

Beginning the Process: Letter of Intent/Term Sheet (3) If not binding: Can structure so that it becomes binding upon approval within a specified time and/or subject to signing a definitive agreement Will need to draft very carefully to ensure non binding letter of intent or term sheet cannot subsequently be found to be binding If no separate confidentiality agreement, ensure that while most of letter of intent is non binding, confidentiality and non solicitation covenants are intended to be binding If not binding, what other provisions need to be binding 13

Parties Which parties should be parties to the JV Parent entities as parties or simply guarantors How far up the chain is it necessary to go To ensure performance of the obligations of the JV parties To enforce non competition covenants, etc. Government entities as parties Should JV entity be a party Specific enforcement of obligations Iterative consideration of structure of JV 14

Governance Depends largely upon the actual structure chosen (another iterative loop back) Management vehicle to direct the JV Extent of the authority given to the management vehicle compared to reserving significant decisions to the joint venturers (shareholders, members or partners); fiduciary duties at different levels will factor into this decision Choice of appointees to the board or management committee & accountability to the joint venturers Authority to retain and remove personnel, including the chief executive officer (continued) 15

Governance (2) Management vehicle to direct the JV (continued) Scope of protection for each joint venturer on fundamental decisions and changes particularly where one of the co venturers has a minority ownership interest Substantive standards and processes for dealing with non arm's length transactions and other conflict of interest situations Process for developing, approving and updating the business plan and budget 16

Management Committee or Board of Directors Board representation or formula If a 50 50 Board is established, will have to deal with deadlock possibility Giving chair a casting vote in 50 50 situation effectively results in unequal representation on Board Particular qualifications for members of management board and any particular prohibitions on who can act Removal and replacement of members of management board (continued) 17

Management Committee or Board of Directors (2) When and how often will management Board meet? Notice requirements Quorum for valid meeting Can management Board members be represented by alternates (generally not permissible in a corporate JV) Who can call meetings Under what circumstances can management Board act without an in person meeting i.e., telephonic meetings or actions by signed consent Powers and duties of management Board Matters requiring approval of parent(s) Matters requiring super majority or unanimity 18

Officers Officers President, CEO Managing Director or general manager Overall leadership versus responsibility for the day to day operations CFO/financial management (continued) 19

Officers (2) Which co venturers have right to nominate which officers or whether the management Board has that right Certain venturers could have right to nominate certain officers; right to nominate could rotate (often found with Chair) Right to remove and replace officers Limits on authority of officers, signing authority, etc. Directors' and Officers' Liability Insurance 20

Auditors, Reporting and Access to Information Who will the auditors be Auditors of one of co venturers or independent How can firm be changed Frequency of financial statements Nature and frequency of other reporting requirements Permitted access for co venturers to books, records and employees Notice, during business hours, etc. Should rights be removed/restricted under any circumstances 21

Actions Requiring Consent Either Board Or Co-venturers Approval of annual business plan and budget or any change to any approved annual business plan or budget Transactions outside the ordinary course of business [over a specified $ annual threshold] Change of name or scope of the business Creation of subsidiaries Admission of new co venturers, transfer of ownership interests, issue, sale or transfer of shares or rights (continued) 22

Actions Requiring Consent Either Board or Co-venturers (2) Incurring debt, granting security or guarantees Payment or other distribution or return of capital Change in management Board, establishment or change in committees or appointment or removal of officers Insolvency related actions Certain types of contracts Approvals required in connection with litigation or other proceedings 23

Disputes Mediation Litigation or arbitration Mandate of arbitrators (i.e., is it any dispute between the party or only specified types of disputes or under specified clauses) Certain types of disputes may not be arbitrable Specific performance Preserving right to go to court for certain types of breaches (e.g., breach of confidentiality, non solicit or non compete) Set out rules or cross reference to specific set of rules (e.g., ICC) Consider whether there should be prohibition on arbitrator amending the JV agreement or granting punitive damages (continued) 24

Disputes (2) Number and how chosen Parameters around how arbitrators are to act (e.g., findings of fact and conclusions of law) Location of actions Applicable law Costs who pays what Breach of JV agreement Determinations of a particular value or payment (e.g., license fees or termination costs) 25

Financing and Support Financing provided by the co venturers Pro rata to interest in JV Optional or a required What if one co venturer does not have the necessary funds? Maximum amount either in actual dollar terms or based upon some formula Who can initiate capital call and who determines what type of capital call it will be debt or, if applicable, equity Consider fixing in advance all relevant terms of debt, including repayment terms, ranking of obligation to repay, etc. (continued) 26

Financing and Support (2) Third party debt financing Non recourse or backed by assets or guarantees If guarantees are to be given, limits and pro rata to the percentage interest Security granted Co venturer support To what extent each co venturer is going to provide support or services to the JV Pricing for such support and services Substitution for co venturer support if not provided 27

Intellectual Property Intellectual property transfer from parents to JV Allocation of rights to parties and JV rights Right of first refusal/preferences Residual and derivative rights Existing agreements that impact the IP and technology Provisions/laws (e.g., Bayh Dole) that may "contaminate" technology or IP IP of the parents family members IP claims or litigation Representations and warranties as to existing Control of claims and litigation Costs Damages and recoveries (continued) 28

Intellectual Property (2) Validity, enforceability, ownership, scope and protection Third party consents Open source software issues Privacy and data protection Local legal regime Statutes and regulations Enforcement IP legal practice Restrictions on the ability to transfer that intellectual property out of the country Protections for intellectual property that is transferred to a venture in that country and intellectual property that the venture develops Risks connected with a state owned or controlled entity? (continued) 29

Intellectual Property (3) Transfers Assignment or by a license Royalties or capital contribution/distributions Exclusivity Ongoing technology/ip obligations to/by the JV Compensation/contribution for foreground IP," which is the IP created by the JV alone or in combination with its JV partners Terms of assignments, exclusive licenses, nonexclusive licenses, or manufacturing/supply agreements for components that embody but do not disclose the IP (continued) 30

Intellectual Property (4) Joint exploitation issues March in rights Reporting, accounting, audit and payment terms issues Term and termination of transfers/payments Cost and Administration of IP registration, enforcement and defense 31

Separation and Termination How the termination will occur Returns of property that a party transferred to the JV, restoration of intangibles Employees, consultants and subcontractors Goodwill Employee benefits Future opportunities Payments to the parents and to creditors Buy out formulas Continued cooperation by parents, noncompetition (continued) 32

Separation and Termination (2) Remedies on termination or separation Accounting Payments Specific performance and prohibitions (injunctions, etc.) Technology issues Licenses Grantbacks and continuing licenses Rights of a withdrawing party Opportunity to grant licenses to a third party Compulsory licensing 33

Separation and Termination (3) Trademarks, databases and other IP Duplication of tangible know how Manuals Work in progress and similar materials. R&D implementation (test beds, prototypes, tooling) 34

References The Role of Intellectual Property Rights in Negotiating and Planning A Research Joint Venture, Kurt M. Saunders, 7 Marq. Intell. Prop. L. Rev. 75 2003 Emerging Challenges of Joint Venture Transactions, Stephen Fraidin and Douglas Pepe, ALI ABA COURSE OF STUDY MATERIALS, Corporate Governance: Current and Emerging Issues, Volume I, November 1998 ABA Model Joint Venture Agreement Checklist for Joint Venture Agreements, Thomas W. Van Dyke, ALI ABA COURSE OF STUDY MATERIALS, Representing the Growing Business: Tax, Corporate, Securities, and Accounting Issues, November 2005 Getting To Know You IP Diligence Issues for APAC Companies Pursuing Deals With U.S. Life Science Companies, PAUL J. MEYER, JR. OF O'MELVENY & MYERS LLP, Intellectual Property Today, April 2011 (continued)

References (2) International Joint Ventures: Setting Them Up, Taking Them Apart, Peter D. Ehrenhaft, ALI ABA COURSE OF STUDY MATERIALS, Fundamentals of International Business Transactions, May 2008 Technology and IP Focused Joint Ventures, Collaborations & Alliances Part I, Weil, Gotshal & Manges LLP, Metropolitan Corporate Counsel, June 2010, Northeast Edition Technology and IP Focused Joint Ventures, Collaborations & Alliances Part II: Focusing On China and India, Weil, Gotshal & Manges LLP, Metropolitan Corporate Counsel, July 2010, Northeast Edition Structuring and Negotiating International Joint Ventures, Michael E. Hooton, 27 Creighton L. Rev. 1013, June, 1994

Presenters Session M110 Monday, October 16, 2017 9:30 a.m. 10:45 a.m. J. Michael Slocum, Esquire Slocum & Boddie, P.C. 5400 Shawnee Road, Suite 300 Alexandria, VA 22312 Tel: 703 451 9001 Fax: 703 451 8557 jmichaelslocum@slocumboddie.com Mir Asghar Ali Khan, Senior Manager Research and Grants Administration Division of Women and Child Health The Aga Khan University Karachi, Pakistan Tel: + 92 213 493 0051 Fax: + 92 213 493 2095 Cell: + 92 (0) 300 827 9739 asghar.ali@aku.edu