Product Assignment 1, dated July 1, 2018, by and between Eiger BioPharmaceuticals, Inc. and RRD International, LLC

Project Agreement. This document constitutes a Project Agreement under the Agreement, and the services contemplated herein are subject to the terms and provisions of the Agreement.

Overview of Services. This Project Agreement, along with the Agreement, describes the terms under which RRD will provide development services to Eiger for its HDV product(s) (the “Product”).

Senior Management and Strategic Oversight

Program Management

Regulatory Affairs and Medical Writing

Clinical Pharmacology Strategy and Phase 1 Study Management

Phase 3 Clinical Study Management

Quality Assurance

Study Protocols. Protocols for the studies are attached hereto as Exhibit A.

Eiger - RRD Product Development Team. The initial Eiger - RRD Product Development Team, as described in Section 2.B(2) of the Agreement, is attached hereto as Exhibit B.

Development Advisory Committee Charter. The Development Advisory Committee Charter, as described in 2.B(3) of the Agreement, is attached hereto as Exhibit C.

Clinical Development Plan. The initial Clinical Development Plan, as described in Section 2.B(4) of the Agreement, shall be attached hereto as Exhibit D when approved by the Development Advisory Committee.

Development Budget and Timeline. The Development Budget for this Project Agreement (including the budget for the conduct of the [***] and the additional activities including strategic and operational development planning / oversight by RRD’s senior management team), as described in Section 2.B(5) of the Agreement, is attached hereto as Exhibit E. RRD will invoice Eiger per the Payment Terms based upon the Development Budget, as such Development Budget is amended from time to time by the Development Advisory Committee.

Payment Terms. The Payment Terms, as described in Section 2.B(6) of the Agreement, are attached hereto as Exhibit F.

Scope of Services. A description of the roles and responsibilities of the Parties, as described in Section 2.B(7) of the Agreement, is attached hereto as Exhibit G.

Consequence of Major Project Delays. In the event of a Major Project Delay ([***]), the Development Advisory Committee shall revise the Clinical Development Plan and Development Budget pursuant to the Agreement and the Development Advisory Committee Charter.  During the first [***] of a Major Project Delay, [***].  Thereafter, unless such Major Project Delay is [***].      

Project Agreement Term; Termination.

Term. The term of this Project Agreement shall commence on the Project Agreement Effective Date and shall continue per the agreed upon Services, Budget and Timeline (the “Project Agreement Term”).

Termination Due to Default, Breach or Termination Without Cause by Eiger.

Each Party may terminate this Project Agreement at any time, upon written notice to the other Party, if the other Party is in material default or breach of the Agreement or this Project Agreement or if the other Party commits a non-material default or breach of the Agreement or this Project Agreement which has resulted in, or would reasonably be expected to result in, a material adverse effect on the non-breaching Party’s rights under the Agreement or this Project Agreement and such material or non-material default or breach continues un-remedied for a period of [***] after written notice thereof is delivered to the breaching or defaulting Party. If the breaching or defaulting Party fails to remedy the default or breach within the applicable cure period, such non-breaching Party may, by notice of termination to the other Party, immediately terminate this Agreement.

Eiger may terminate this Project Agreement without cause with [***] prior written notice, subject to the consequences of such termination as outlined herein.

Upon termination of this Project Agreement by Eiger pursuant to Section 11.B(2) or termination by RRD pursuant to Section 11.B(1) herein or Section 15(A)(1)(d) of the PDA, Eiger shall [***]. In the event a [***] is applicable, the following shall apply: (a) [***], and (b) [***]. In the event that the aggregate amount of Service Fees and Wind-down Fees paid by Eiger as provided in the foregoing sentence exceeds the amount of [***], RRD shall promptly reimburse the excess amount to Eiger.    

Termination Due to: (1) Medical, Scientific/Regulatory or Safety Reasons Related to the Drug Product and/or the Administration Thereof; or (2) Termination by RRD Based on the Parties’ Inability to Agree Upon an Amendment to the Development Budget or Clinical Development Plan.

The Development Advisory Committee has the authority, upon the unanimous agreement in good faith by all members, to terminate this Project Agreement in the event that medical, scientific/regulatory or safety reason(s) related to the drug product(s) that is the subject of this Project Agreement and/or the administration thereof justify such termination, in its sole and absolute discretion.  In such event, this Agreement will be deemed to have been mutually terminated by the Parties.

RRD may terminate this Project Agreement with [***] prior written notice in the event of RRD and Eiger’s inability to materially agree in good faith on a Material Amendment to the Development Budget or Clinical Development Plan.  As used herein, a “Material Amendment” means an amendment proposed by either Party that (a) is material to the conduct of this Project Agreement and (b) is not attributable to any act or failure to act by RRD (including any material default or breach of the Agreement or this Project Agreement by RRD).

Upon termination of this Project Agreement for any reason, a transition plan will be developed to wind down the Services (which transition plan may cover a period that is shorter than the applicable notice period), and such transition plan will be submitted for approval to the Development Advisory Committee outlining the fees, expenses and timing of such transition plan

(the “Wind-down Fees”). RRD shall implement such transition plan only upon approval thereof by the Development Advisory Committee, including the budget therefore. Once approved by the Development Advisory Committee, the transition plan shall become part of the Clinical Development Plan (as amended) hereunder, and the transition budget, including “Wind-down Fees”, shall become part of the Development Budget (as amended) hereunder.

Upon the termination of this Project Agreement for any reason, RRD shall immediately return to Eiger any unused portion of the Deposit advanced by Eiger to RRD as described in the Payment Terms.

Amendments. No modification, amendment, or waiver of this Project Agreement shall be effective unless in writing and duly executed and delivered by each Party.

RRD INTERNATIONAL, LLC

EIGER BIOPHARMACEUTICALS, INC.

By:

/s/ J. Scott Tarrant

By:

/s/ David Cory

Name:

J. Scott Tarrant

Name:

David Cory

Title:

President

Title:

Chief Executive Officer

Date:

8/11/18

Date:

8/11/18

Purpose. The Development Advisory Committee is established by Eiger and RRD to oversee the Clinical Development Plan and the Development Budget for the Programs.

Authority and Duties.

Generally. The role of the Development Advisory Committee will be to provide oversight and direction for the program, review critical issues as they arise and to make recommendations to Eiger’s management. In addition, the Development Advisory Committee shall decide on any other matters relating to the Clinical Development Plan and the Development Budget that may arise, including (i) responding to requests from RRD or Eiger for amendments to the Clinical Development Plan and/or the Development Budget, and (ii) addressing all other matters that are identified in the Agreement as requiring the input or approval of the Development Advisory Committee. The foregoing list of duties is not exhaustive, and the Development Advisory Committee may, in addition, perform such other functions as may be necessary or appropriate for the performance of its duties and the furtherance of the development of Programs, including as may be required under the Agreement.

Clinical Development Plan and Development Budget Approvals. Approximately [***] after the execution of this Project Agreement, the Development Advisory Committee shall meet and approve (pursuant to the approval procedures described in Section 5 of this Charter) the Clinical Development Plan and the Development Budget. Thereafter, the Development Advisory Committee shall continue to develop and refine the Clinical Development Plan and Development Budget and shall approve any revisions to the Clinical Development Plan and Development Budget (pursuant to the approval procedures described in Section 5 of this Charter). Notwithstanding the foregoing, the Development Advisory Committee shall review the Clinical Development Plan and Development Budget no less frequently than on a semi-annual basis. Any approval or non-approval of the Clinical Development Plan and Development Budget by the Development Advisory Committee shall be recorded in the minutes of such meeting.

Ongoing Review of the Program.  The Development Advisory Committee shall be the primary means by which Eiger shall provide oversight and input to the Services provided by RRD. In the event the Services do not conform to the Clinical Development Plan, the Development Budget or Eiger’s reasonable expectations, the Development Advisory Committee members shall work together in good faith to resolve such non-conformities and any impact this may have to the Clinical Development Plan or Development Budget. If the Development Advisory Committee members are unable to resolve such issues at the Development Advisory Committee level, the chief executive officers/presidents of each Party shall meet in person (or, with the consent of both parties, via teleconference) to negotiate a resolution. If the Parties are unable to achieve a resolution following the meeting of the chief executive officers/presidents, the matter shall be resolved by Eiger, subject to RRD’s rights to terminate the Agreement and/or the Project Agreement pursuant to Section 15 of the Agreement and/or Section 11 of the Project Agreement.

Composition.

The Development Advisory Committee shall consist [***] representation from RRD and Eiger with a minimum of [***] appointed by Eiger and a minimum of [***] appointed by RRD. Each Party may bring additional employees or representatives to each meeting as observers, but only if such employees or representatives are bound by confidentiality obligations at least as stringent as those previously defined in the Agreement.

Each Development Advisory Committee Member shall have the requisite background, experience and training to carry out the duties and obligations of the Development Advisory Committee. Development Advisory Committee Members need not be members, directors or employees of either Party.

The Chair of the Development Advisory Committee shall be appointed by Eiger and shall initially be [***].

By written notice to Eiger, RRD may remove or replace one or more Development Advisory Committee Members designated by RRD. By written notice to RRD, Eiger may remove or replace one or more Development Advisory Committee Members, including the Chair, designated by Eiger.

Operations.

The Development Advisory Committee shall meet at least twice per year during the Term, unless and until the Development Advisory Committee determines that such meetings should occur at a greater or lesser frequency (in either case, each a “Scheduled Meeting”).  Scheduled Meetings may be held in person or by teleconference when appropriate. Eiger shall be solely responsible for RRD’s reasonable out-of-pocket costs associated with Development Advisory Committee attendance and participation in any such Meetings that are held in person, but may direct RRD to pay such costs from the Development Budget. In addition, any Development Advisory Committee Member may call for an ad hoc meeting of the Development Advisory Committee to be held by teleconference at any time, by giving at least [***]’ notice to the other members of the Development Advisory Committee unless such notice is waived by all of the members. An Ad Hoc Meeting may be called to address any time-sensitive matter, including changes to the Clinical Development Plan and/or Development Budget.

The Chair, or such person as the Chair may designate, shall, in consultation with other Development Advisory Committee Members, develop and set the Development Advisory Committee’s agenda for each Scheduled Meeting. The agenda and information concerning the business to be conducted at each Scheduled Meeting shall be communicated in writing to the Development Advisory Committee Members at least one (1) week in advance of such Scheduled Meeting to permit meaningful review. Such an agenda shall not be required for an Ad Hoc Meeting; however, the purpose of the meeting shall be stated in the notice thereof.

The Chair, or such person as the Chair may designate, shall prepare and distribute to all Development Advisory Committee Members, draft committee minutes within a reasonable period of time following each Scheduled Meeting and Ad Hoc Meeting, but in any case, in sufficient time to be included as part of the agenda for the next Scheduled Meeting. As part

of the agenda of the first Scheduled Meeting, the Development Advisory Committee Members shall agree upon a standard procedure for review and approval of such draft committee minutes by the Development Advisory Committee Members.

Approval Procedures.

Approval at a Meeting of the Development Advisory Committee. [***].

Approval by Unanimous Written Consent. Notwithstanding anything to the contrary, the Development Advisory Committee may approve any matter via unanimous written consent signed by all members of the Development Advisory Committee.

If the Parties are unable to approve any matter as provided in subsection (A) or (B) above, the matter shall be resolved by Eiger, subject to RRD’s rights to terminate the Agreement and/or the Project Agreement pursuant to Section 15 of the Agreement and/or Section 11 of the Project Agreement.

General

Version 1.0: July 2018: Initial budget estimate covering [***].

Version 2.0: Q1 2019: Revised budget estimate to capture [***].

Additional and/or subsequent budget revisions:  Material budget changes outside of RRD’s control (i.e., actual cost of negotiated third-party contracts, enrollment issues, safety issues, a truncated or extended clinical study, etc.) may only be made upon the recommendation of the Development Advisory Committee and with Eiger management’s prior approval.

Program Timeline (July 1, 2018 – August 31, 2022)

Economic Structure

PDT Fixed Fee Program Budget

Cash Compensation.

Equity Compensation.

Estimated Expert Consultant and Pass-Through Budget¹

Payment Schedule for RRD PDT Fixed Fees - Cash Component and Equity Vesting Schedule [***]²

Incentive Fees.

Generally. In regard to the budgeted service fees for RRD’s Senior Development Management and Core Development Team, RRD shall invoice Eiger per the payment schedule detailed in Section 8 of Exhibit F. In addition, costs incurred for RRD Expert Consultants and Subcontractors and amounts paid for actual travel and other associated pass-through expenses shall be invoiced monthly, in arrears, subject to the deposit described below.

Initial Payments.  

Initial Cash Payment.  Immediately upon execution of Project Agreement No. 1, Eiger shall make a cash payment to RRD in the amount of [***] which represents: (a) [***]; and (b) [***].

Equity. Eiger shall issue to RRD the Share Certificate within [***] after execution of Project Agreement No. 1 as described in Exhibit E.

Subsequent Payments. Subsequent to the Initial Payment, RRD shall invoice Eiger, and Eiger shall pay to RRD:

As scheduled, per Section 8 of Exhibit F.  In the event of a modification of the Development Budget, upon approval of the Development Advisory Committee, RRD and Eiger will negotiate an amendment to the payment schedule in good faith consistent with the revised Development Budget over the remainder of the term; and

On a [***] basis, RRD shall invoice Eiger for the RRD Expert Consultant fees and actual amount of pass-through expenses (including RRD Subcontractors) incurred during the most recently completed month, [***].  RRD shall promptly (i) pay all invoices for RRD Expert Consultant fees and pass-through expenses (including RRD Subcontractors) for Services contemplated under this Project Agreement No. 1 in accordance with the payment terms of the applicable agreement between such RRD Expert Consultant or RRD Subcontractor and RRD and (ii) provide Eiger with reasonable evidence of such payment when made by RRD.  In the event the aggregate net amount of such costs paid by RRD at any one time is equal to or greater than the amount of the Deposit, Eiger shall either be responsible for paying such further payments directly to the respective vendors or reasonably increasing the amount of the Deposit to RRD to cover such net payments going forward.

RRD reserves [***].

Upon termination of this Project Agreement, RRD will reconcile unpaid service fees earned (including wind-down fees, if any), unreimbursed RRD Expert Consultant fees and pass-through expenses (including RRD Subcontractors), and all other unreimbursed pass-through expenses against the balance of funds previously advanced by Eiger. Any excess of unapplied Eiger deposits over unpaid fees, costs and expenses will be offset against (i.e., deducted from) the final billing due to Eiger.  If such excess is not able to be completely offset in this manner, the difference will be promptly refunded by RRD to Eiger, or alternatively, Eiger can in its sole discretion offset it against any payments still due to RRD under previous invoices.  

Miscellaneous.

RRD shall invoice Eiger for RRD Expert Consultants and Subcontractors and pass-through expenses (i.e., travel, postage / delivery, phone charges, etc.) in arrears, on a monthly basis.

All pass-through expenses, as identified in the Development Budget, shall be billed to Eiger without mark-up.

All fees, costs, and expenses invoiced by RRD to Eiger, will be payable in US Dollars and are due within [***] of the receipt of the invoice.  If Eiger disputes in good faith any portion of an invoice, then Eiger shall pay the undisputed portion of the invoice, and the parties shall use good faith efforts to reconcile the disputed amount as soon as practicable. RRD shall not be required to pay, nor be liable for its failure (or delay) to pay, any fees to RRD Expert Consultants and

Subcontractors or any pass-through expenses if the balance of the payments made by Eiger pursuant to Section 2 and Section 3B above is insufficient to cover any such payment due by RRD, and provided that such insufficiency is solely the result of Eiger’s delayed payment of, under-payment of, or failure to pay any billing by RRD for such expenses or advances therefor.

RRD shall transmit invoices to Eiger at the following email addresses:

SERVICES. RRD will provide the following Services in support of the Phase 1 and Phase 3 HDV Program:

Senior Management and Strategic Oversight

Program Management

Regulatory Affairs and Medical Writing

Clinical Pharmacology Strategy and Study Management

Phase 3 Clinical Operations and Study Management

Quality Assurance

DESCRIPTION OF SERVICES.

Senior Management and Strategic Oversight

Program Management

Regulatory Affairs and Medical Writing

Clinical Pharmacology Strategy and Study Management

Phase 3 Clinical Operations and Study Management

Quality Assurance

LIST OF TASKS AND RESPONSIBILITIES.

Summary

NDA Strategy and Planning, NDA Application Preparation/Submission, and Key Meetings with FDA

Reference Timeline - NDA Strategy and Planning, NDA Application Preparation/Submission, and Key Meetings with FDA