[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

Exhibit 10.1

PRODUCT DEVELOPMENT AGREEMENT

This Product Development Agreement (this “Agreement”) is effective July 1, 2018
(the “Effective Date”) and is between RRD International, LLC, a Delaware limited
liability company with offices at 7361 Calhoun Place, Suite 510, Rockville,
MD  20855 (hereinafter “RRD”) and Eiger BioPharmaceuticals, Inc., a Delaware
corporation with executive offices at 2155 Park Boulevard., Palo Alto, CA  94306
(hereinafter “Eiger”).  Each of RRD and Eiger is a “Party” and together they are
the “Parties.” When signed by both Parties, this Agreement will set forth the
terms and conditions under which RRD agrees to provide certain product
development services to Eiger as set forth herein.

Recitals:

WHEREAS, Eiger is engaged in the development and commercialization of novel
pharmaceutical products.  

WHEREAS, RRD provides strategic product development services for the development
of pharmaceutical products by utilizing a Product Development Team (“PDT”)
structure that functions similarly to a biopharma’s PDT and includes
senior-level experts who are fully engaged in product development strategy and
planning.  

WHEREAS, RRD’s model is specifically structured to create a strong alignment of
interests between RRD and its clients, while accelerating and streamlining the
development process. Within this framework, the RRD team will function as the
part of the Eiger PDT and will provide engagement, oversight, and management of
third-party Clinical Research Organizations (“CROs”) and vendors, in each case,
to the extent requested by Eiger.

WHEREAS, Eiger desires to engage the services of RRD for the development of
certain products, with such services to be described and agreed upon by the
Parties within the Project Agreements (as defined below).  

NOW THEREFORE, in consideration of the premises and the mutual covenants
contained herein and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties agree as follows:

1.

Project Agreements.  

 

A.

As a “master” form of contract, this Agreement allows the Parties to contract
for multiple projects through multiple Project Agreements, without having to
renegotiate the basic terms and conditions herein.

 

B.

The specific details of each assignment or task for the development of each
individual Eiger product will be separately negotiated and specified in a
written project agreement (each, a “Project Agreement”) on terms acceptable to
the Parties.

 

C.

Upon execution by RRD and Eiger, each Project Agreement shall constitute an
integral part of this Agreement. Each Project Agreement will include
substantially all of the information relating to the specific services to be
conducted by RRD (as related to each Project Agreement, the “Services”)
including the items listed in Section 1.D, below.  No Services shall be
commenced or performed by RRD, and neither Party shall be obligated with respect
to any assignment or task, until an applicable Project Agreement is executed by
both Parties, nor shall either Party be obligated to enter into any Project
Agreement hereunder. Each Project Agreement shall be subject to all of the terms
and conditions of this Agreement, in addition to the specific details set forth
in the Project Agreement. In the event of any inconsistency between this
Agreement and

1

--------------------------------------------------------------------------------

 

 

 

any Project Agreement, this Agreement shall control. Any changes to a Project
Agreement must be made in writing and signed by the Parties. RRD shall perform
all Services under any Project Agreement in a diligent, professional and timely
manner in accordance with the terms of this Agreement, such applicable Project
Agreement and all applicable laws and regulations.

 

D.

Each Project Agreement shall contain the following exhibits as listed below as
more specifically described herein:

 

▪

Initial Protocol Assumptions

 

▪

RRD Product Development Team

 

▪

Development Advisory Committee Charter

 

▪

Clinical Development Plan

 

▪

Development Budget

 

▪

Payment Terms

 

▪

Description of Services

2.

Overview of Development.

 

A.

Generally.

 

(1)

RRD and Eiger shall enter into a separate Project Agreement for each Eiger
product/indication that shall be developed pursuant to this Product Development
Agreement.

 

(2)

Each Project Agreement shall contain all of the information, available as of the
date of execution thereof, that is necessary to describe the goals and
objectives (including cost) of the applicable product development program (the
“Program”).  During the initial [***] of the term of each Project Agreement, the
Parties will work diligently and in good faith to refine (including amending, to
the extent necessary) the initial Clinical Development Plan and Development
Budget.  Approximately [***] following commencement of the applicable Project
Agreement, or upon the next meeting of the Development Advisory Committee (as
defined in Section 2(B)(3)), the Development Advisory Committee shall review and
formally approve (pursuant to the approval procedures described in the
Development Advisory Committee Charter (as defined in Section 2(B)(3)) attached
to the respective Project Agreement) the most recently submitted Clinical
Development Plan and Development Budget, or shall request specific changes
thereto (pursuant to the procedures described in the Development Advisory
Committee Charter attached to the respective Project Agreement) which, when
incorporated into the Clinical Development Plan and/or Development Budget, will
render such documents approved without further action by the Development
Advisory Committee. Thereafter, the Clinical Development Plan and Development
Budget shall continue to be developed, refined and amended (pursuant to the
approval procedures described in the Development Advisory Committee Charter
attached to the respective Project Agreement), as necessary by the Development
Advisory Committee, in accordance with this Agreement and the applicable Project
Agreement, throughout the term of the Project Agreement.  

2

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

(3)

Utilizing the RRD Product Development Team (as defined in Section 2(B)(2)), RRD
shall conduct the Services for each Program in accordance with the joint
decision-making process, as set forth in the Development Advisory Committee
Charter for that particular Program.

 

(4)

RRD shall have responsibility for the conduct of the Services and for all
matters designated to RRD in this Agreement and in the Project Agreement
(including the Clinical Development Plan) and, to the extent included in the
Project Agreement, may engage Development Vendors (as defined below),
consultants, contractors and agents external to the RRD Product Development Team
(“RRD Consultants and Subcontractors”), as deemed necessary by the Parties, with
the prior agreement of Eiger, to carry out such assigned duties set forth
therein and herein consistent with the Section 4 (RRD Responsibilities). Eiger
hereby acknowledges that while RRD may provide advice and guidance in the
negotiation of vendor contracts between Eiger and one or more third parties with
respect to the Program, and RRD and RRD-contracted attorneys may be part of the
PDT, under no circumstances will RRD be expected by Eiger to provide legal
advice or legal services and no attorney-client relationship is created or shall
exist between the Parties under this Agreement.

 

(5)

The consideration to be paid by Eiger to RRD for the Services will be based
upon: (a) the PDT service fees; and (b) the RRD Consultants and Subcontractors
and pass-through costs, to the extent such service fees and pass-through costs
are included in the Development Budget for the particular Project Agreement.  

 

B.

Project Specific Exhibits to the Project Agreements.

 

(1)

Initial Protocol Assumptions.  The Initial Protocol Assumptions exhibit to each
Project Agreement shall represent the understanding of the Parties as to the
requirements of the Program as of the date of the Project Agreement.

 

(2)

RRD Product Development Team.

The RRD Product Development Team exhibit for each Project Agreement shall list
the staff and personnel intended to be retained or used by RRD in providing the
Services (the “RRD Product Development Team”). RRD shall not change key staff
and personnel on RRD Product Development Team without consulting with Eiger.  If
any staff or personnel on RRD Product Development Team is no longer employed by
RRD or otherwise no longer available, RRD shall promptly notify Eiger and shall
use diligent efforts to find a suitable replacement.  Per the specific Project
Agreement, RRD will assume both responsibility and accountability for the
Project.  The model provides for a fully-integrated, multi-functional PDT
deployed on a fractional FTE basis with the flexibility of scaling up or down
based upon the Clinical Development Plan and the Development Budget.

 

(3)

Development Advisory Committee Charter.

The Parties shall establish and maintain a separate committee (the "Development
Advisory Committee") to oversee the development of each of the Programs
(including the ongoing development and refinement of the Clinical Development
Plan and the Development Budget). The Development Advisory Committee shall be
established, operated and governed in accordance with the policies and
procedures set forth in the "Development Advisory Committee Charter", attached
to each Project Agreement. The Development Advisory Committee Charter may be
amended only with the unanimous approval of the Development

3

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

Advisory Committee Members. In no event shall the Development Advisory Committee
have the power to amend the terms of this Agreement or the applicable Project
Agreement.

 

(4)

Clinical Development Plan.

An initial version of a Clinical Development Plan shall be prepared by the PDT
and formally approved by the Development Advisory Committee (“DAC”), according
to a time line agreed to by the DAC, which is generally expected to be within
[***] after the execution of the Project Agreement. The Clinical Development
Plan shall describe the Services to be conducted under the Project Agreement
(specifically excluding IP work) including: preclinical pharmacology and
toxicology, regulatory, CMC (Chemistry, Manufacturing and Controls), and
clinical (including clinical pharmacology). The Clinical Development Plan will
also include project timeline and budget information. The exact level of detail
to be included in the initial version of the Clinical Development Plan will be
proposed by the PDT and agreed to by the DAC.  The Plan is generally prepared
using PowerPoint and will have appendices containing appropriate supportive
information.

The Clinical Development Plan is intended to be updated periodically to reflect
changes. The PDT shall, on an ongoing basis, evaluate if changes to the Clinical
Development Plan are necessary and will propose such changes to the DAC in
accordance with the approval procedures described in the Development Advisory
Committee Charter.  

 

(5)

Development Budget.

The “Development Budget” directly associated with each Project Agreement shall
consist of two (2) components: (i) PDT service fees, and (ii) RRD Consultant and
Subcontractor costs and other pass-through costs, in a format and level of
detail to be agreed upon by the DAC.

The DAC shall formally approve (in accordance with the approval procedures
described in the Development Advisory Committee Charter) a draft Development
Budget (which shall include RRD Consultants and Subcontractors and pass-through
cost estimates ([***])) approximately [***] after the execution of the related
Project Agreement based upon the initial Development Budget/estimate, as well as
information gathered during the [***] following execution of the Project
Agreement, and such draft Development Budget will be proposed to, and approved
by, Eiger. The DAC may propose and submit to Eiger for its approval changes to
the Development Budget from time to time in accordance with this Agreement. All
anticipated expenditures under the Project Agreement shall be included in the
Development Budget.  

Separate budgets for the Development Vendors (as defined below) will be reviewed
with the Development Budget by the DAC, in context of the overall program
budget.

 

(6)

Payment Terms.  Any specific payment terms, if any, that are applicable to a
Project shall be included in the exhibit to the respective Project Agreement.

 

(7)

Description of Services.  All Services to be conducted by RRD in connection with
each Product shall be included and described in the exhibit to the Project
Agreement.

 

C.

Amendments to the Clinical Development Plan and Budget.

 

(1)

Any amendments to, and all material deviations from, the Clinical Development
Plan and/or the Development Budget (including amendments or deviations made at
the request of RRD

4

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

or Eiger) shall be made in accordance with the procedures described herein and
the approval procedures described in the Development Advisory Committee Charter
attached to the respective Project Agreement.  Notwithstanding the foregoing,
all amendments to, and all material deviations from the Clinical Development
Plan and/or the Development Budget shall require the prior written approval of
Eiger, subject to RRD’s rights to terminate herein and in any relevant Project
Agreement.

 

(2)

The DAC shall perform a comprehensive review of the Clinical Development Plan
and Development Budget, at a minimum, on a semi-annual basis to determine
whether any changes are required, and shall comply with all procedures required
to amend the Clinical Development Plan or Development Budget and to implement
such changes as described above. The DAC shall, on an ongoing basis, continue to
refine the Clinical Development Plan and Development Budget, including, without
limitation, in response to requests, proposals or reports from Eiger and RRD to
the DAC.  The DAC shall review and recommend such change(s) for approval by
Eiger within the next [***] period, or shall request specific changes thereto.

 

(3)

The Clinical Development Plan shall not be amended in any manner that would
require Eiger or RRD (or any person acting on behalf of Eiger or RRD) to perform
any assignments or tasks in a manner that would violate any applicable law or
regulation. In the event of a change in any applicable law or regulation that
materially affects the conduct of the Clinical Development Plan, the DAC shall
consider amending the Clinical Development Plan to enable Eiger or RRD (or any
person acting on behalf of Eiger or RRD), as the case may be, to comply fully
with such law or regulation. If such amendment is not approved, the affected
Party shall be excused from performing any activity specified herein or in the
Clinical Development Plan that would violate or result in a violation of the
applicable law or regulation.

 

(4)

All changes to the Clinical Development Plan and/or Development Budget
(including any components thereof) made pursuant to this Agreement and the
Development Advisory Committee Charter shall have the effect of an amendment to
the applicable Project Agreement as it applies to the Clinical Development Plan
and/or Development Budget contained therein.

3.

Compensation. The consideration to be paid by Eiger to RRD for its conduct of
the Services will consist of (a) a fixed fee to be paid for the Services
conducted by the PDT, (b) Expert Consultant Fees, and (c) pass through costs to
be paid for the RRD Consultants and Subcontractors engaged by RRD to conduct
Services, in each case to the extent identified in the Development Budget for
the particular Project Agreement. Payment Terms shall be attached to each
relevant Project Agreement.   RRD is solely responsible for filing all tax
returns and submitting all tax payments as required by any federal, state,
local, or foreign tax authority arising from the payment received by RRD under
this Agreement, and agrees to do so in a timely manner.  If applicable, Eiger
will report the payments to RRD under this Agreement by filing Form 1099-MISC
with the Internal Revenue Service as required by law.  

4.

RRD Obligations.

 

A.

Generally.

 

(1)

RRD shall have primary, but not sole, responsibility for implementing the
Clinical Development Plan. Without limiting the foregoing, except as
subcontracted to third parties as agreed upon by Eiger and RRD, RRD shall be
responsible for (i) performing all non-clinical and clinical development for
each Program in accordance with the Clinical Development Plan,

5

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

and (ii) undertaking such other activities as are set forth in the Clinical
Development Plan that are assigned to RRD by the DAC pursuant to the Clinical
Development Plan (collectively, the "RRD Obligations").

 

(2)

The Parties anticipate and agree that RRD and Eiger will enter into 3way
agreements with the vendors necessary to execute the Development Plan
(“Development Vendors”) solely for the purpose of providing RRD with the
authority to manage such Development Vendors (including providing oversight and
direction to such Development Vendors, reviewing and approving invoices, etc.)
and for purposes of avoiding conflicting instructions to such Development
Vendors, RRD shall be the main point of contact on such contracts.  Although RRD
will be a party to such contracts, provided that in the management of such
contract and Development Vendors, RRD complies with the terms and conditions of
the applicable Clinical Development Plan, Project Agreement, this Agreement,
Eiger’s reasonable instructions (in compliance with this Agreement) and
applicable laws and regulations, then Eiger shall be solely responsible for: (x)
[***]; (y) payment obligations; or (z) [***].

 

(3)

With respect to staff and personnel retained or used by RRD in providing
Services under this Agreement, RRD shall cause such staff and personnel to
exercise the same standard of care, skill, prudence, diligence and commitment of
time and effort as is customary in its industry. RRD shall ensure that all such
staff and personnel comply with the terms and conditions of this Agreement,
including without limitation confidentiality and intellectual property
provisions.  RRD shall be responsible for the actions of such staff and
personnel performed under this Agreement.  

 

B.

Subcontracting by RRD.

 

(1)

Generally. Except as noted above, RRD may engage third parties for commodity
services that are not otherwise a part of the PDT (RRD Consultants and
Subcontractors), subject to the prior written consent of Eiger (including
without limitation CROs), to perform any of RRD’s obligations under this
Agreement; provided, however, that RRD shall remain responsible for all of RRD’s
obligations hereunder.  RRD shall be responsible for the direction and
coordination of the services of all RRD Consultants and Subcontractors, shall
ensure their compliance with the terms and conditions of this Agreement and the
relevant Project Agreement and shall be responsible for the compliance by any
RRD Consultant or Subcontractor with the terms and conditions of this Agreement
and/or the relevant Project Agreement.

 

(2)

Payments to RRD Subcontractors and Consultants.  RRD shall enter into contracts
(and change orders thereto) with RRD Consultants and Subcontractors only with
the prior consent and approval of Eiger (each, an “Approved Contract”).  RRD
hereby agrees that (a) it will enter into Approved Contract on terms and
conditions that are consistent with those set forth herein, including without
limitation confidentiality, records, intellectual property and termination
provisions, (b) it will promptly apply all advance payments made by Eiger for
use in paying third parties under the appropriate Approved Contract and (c) it
will provide Eiger with monthly reconciliation statements confirming the
application of all such advances made by Eiger.  By providing such prior consent
and approval, Eiger agrees [***]; provided, that, RRD will provide Eiger with
prior written notice if any such fee is reasonably expected to become due and
payable under any Approved Contract.  

6

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

(3)

Clinical Investigators. The Parties acknowledge and agree that Clinical
Investigators shall not be considered the employees, agents or subcontractors of
RRD or Eiger, and that Clinical Investigators shall exercise their own
independent medical judgment. As used herein, “Clinical Investigator” means any
third party medical and/or research professional acting as the lead investigator
in a study under the applicable Project Agreement.

 

C.

Reports and Correspondence.  

 

(1)

Records. RRD will keep complete and accurate records of the status and progress
of each Program (“Records”), including Records of all data and results generated
from the Program, as set forth in the Project Agreement.  Upon reasonable
advance notice, Eiger shall have the right to inspect and copy all such
Records.  

 

(2)

Report.  RRD shall keep the DAC informed of its activities under the Clinical
Development Plan, as set forth in this Section, through regular reports, not
less than once per calendar quarter (“Reports”).  All Reports will be prepared
in the standard format of RRD unless otherwise specified in the Project
Agreement or as otherwise agreed to by the DAC.  At each scheduled meeting of
the DAC, or according to a schedule agreed to by the DAC, RRD shall, to the
extent reasonably required by the DAC, provide a summary of the technical and
financial information related to each Program in a format, and to a level of
detail, as reasonably required by the DAC.  

 

(3)

Event Resulting in a Material Effect.  RRD shall notify at least one (1) of the
DAC Members designated by Eiger as soon as possible, but no later than [***],
following RRD’s knowledge of the occurrence of any event that has, or could
reasonably be expected to have, in RRD's judgment and in light of the
circumstances existing at the time, a material effect on the Clinical
Development Plan or the Development Budget and shall keep the DAC regularly
updated and informed with respect to any such event.

 

D.

Staffing.  RRD shall provide sufficient and competent staff and personnel
(including, without limitation, such employees or agents of RRD Consultants and
Subcontractors retained by RRD) that have the skill and expertise necessary to
perform RRD’s obligations under this Agreement and the applicable Project
Agreement.

 

E.

QA Audit. During the term of this Agreement, RRD will permit Eiger
Representatives to examine and audit, during regular business hours, the
Services conducted by RRD hereunder and the facilities at which such Services
are conducted to determine that RRD’s obligations are being conducted in
accordance with the terms of this Agreement, the Project Agreement, and the
Clinical Development Plan ("QA Audits"). Eiger shall give RRD reasonable advance
notice of any such QA Audit specifying the proposed scope of the QA Audit.  For
QA audits conducted more than [***] per [***] period (other than for cause or
follow up audits), Eiger shall reimburse RRD for its time associated in
participating in such QA Audit.  As used herein, “Eiger Representatives” shall
mean representatives identified by Eiger in advance and reasonably acceptable to
RRD, each of which shall enter into a confidentiality agreement with RRD (if not
already covered by an existing CDA) obligating them to keep confidential any
Confidential Information of RRD disclosed in connection with the conduct of any
such QA Audit.

 

F.

Financial Audit of RRD Pass-Through Costs.  RRD shall keep and maintain for
[***] after the effective date of termination of any applicable Project
Agreement complete and accurate records of all external costs and expenses
incurred by it in connection with the conduct of the Services as

7

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

part of such Project Agreement in sufficient detail to allow confirmation of
same and to allow confirmation that all advance payments made by Eiger were
properly allocated by RRD to Approved Contracts.  During the Term and [***]
thereafter, RRD will permit an independent certified public accounting firm
reasonably acceptable to RRD to audit and verify such costs and expenses (each,
a "Financial Audit"), which audit shall be conducted during regular business
hours and will take place upon Eiger’ request, unless otherwise agreed to by the
Parties. Eiger shall give RRD reasonable advance notice of such Financial Audits
specifying the proposed scope of the Financial Audit, which shall not include
the records for any period that has previously undergone a Financial Audit. For
Financial Audits conducted more than [***] per [***] period (other than for
cause or follow up audit), Eiger shall reimburse RRD for its time associated
with participating in such Financial Audits.

5.

Eiger Obligations.

 

A.

Insurance. [***].  Such insurance shall carry a minimum [***] of coverage. Upon
RRD’s request, Eiger shall instruct its insurance carrier(s) to promptly furnish
to RRD certificates reflecting such coverage and a covenant of Eiger confirming
that such coverage shall not be canceled or otherwise terminated during the Term
without [***] prior written notice to RRD.  Notwithstanding anything to the
contrary herein, this Section shall survive for a period of [***] following
termination or expiration of this Agreement. Such insurance coverage, with
regard to coverage for specific clinical trials, shall remain in place for a
period of [***] after the conclusion of the respective clinical trial.  The
foregoing obligations of Eiger for any of the above [***] periods may be
satisfied by Eiger through any combination of renewal policies or extended
reporting period endorsements.

B.Cooperation; Delays; Disclosure of Hazards.

Eiger shall forward to RRD, in a timely manner, all data and information in
Eiger’ possession or control necessary for RRD to conduct the Services (“Eiger
Information”).  RRD shall not be liable for, nor be deemed to have breached this
Agreement for, any delays in the conduct of the Services that arise from Eiger’
failure to provide Eiger Information in a timely manner or Eiger’ failure to
otherwise cooperate with RRD to the extent required by the applicable Project
Agreement. Eiger shall promptly provide RRD with all any information of which
Eiger is aware regarding known or potential hazards associated with the use of
any substances supplied by Eiger, and Eiger shall comply with applicable laws
and regulations concerning the shipment of such substances to RRD.

 

C.

Eiger agrees to provide any new safety information related to a Program as soon
as reasonably practical.

6.

Mutual Covenants.  Each of Eiger and RRD covenants and agrees that, with respect
to the Programs and any other rights and obligations set forth herein, it shall:

 

A.

perform all of its obligations pursuant to this Agreement in material compliance
with: (i) all applicable international, federal and state laws, statutes, rules,
regulations and orders (including all applicable approval and qualification
requirements thereunder), including, without limitation, the Federal Food, Drug
and Cosmetic Act and the regulations promulgated pursuant thereto; (ii) all
applicable good clinical practices and guidelines; (iii) all applicable standard
operating procedures; (iv) all applicable protocols; (v) the provisions of this
Agreement and Project Agreements and (vi) with respect to RRD, RRD shall perform
the Services in a professional manner;

8

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

B.

not employ (and shall not use any contractor or consultant who is or that
employs) any individual or entity debarred by the Food and Drug Administration
(“FDA”) (or subject to a similar sanction of any other regulatory authority),
or, to the best of its knowledge, any individual who or entity which is the
subject of an FDA debarment investigation or proceeding (or similar proceeding
of any other regulatory authority), in the conduct of the Programs; and with
respect to RRD, RRD shall promptly notify Eiger in the event any RRD employee,
contractor or consultant is under or threated to be under investigation by the
FDA or is subject to debarment by the FDA during the term of this Agreement;

 

C.

promptly deliver to the other, upon receipt thereof, notice of all actions,
suits, investigations, litigation and proceedings before any governmental
authority, which would reasonably be expected to affect such Party’s ability to
perform its obligations under this Agreement.

Upon its acquiring knowledge of (i) any possible breach by it of any
representation, warranty, covenant or any other term or condition of this
Agreement or (ii) any other event or development, in each case that may, or may
be reasonably expected to be, materially adverse to the other Party with respect
to any Program, such Party shall promptly notify the other Party in writing
within [***] of acquiring such knowledge; provided, that the failure to provide
such notice shall not impair or otherwise be deemed a waiver of any rights any
Party may have arising from such breach, event or development and that notice
under this Section shall not be deemed an admission by the Party providing such
notice of any breach of this Agreement.

7.

Representations and Warranties.

 

A.

RRD Representations and Warranties.  RRD hereby represents and warrants to Eiger
that, as of the Effective Date:

 

(1)

Organization. RRD is a limited liability company, duly organized, validly
existing and in good standing under the laws of the State of Delaware.

 

(2)

Authority and Validity. RRD has all requisite corporate power and authority to
execute, deliver and perform its obligations under this Agreement and to
consummate the transactions contemplated thereby. The execution, delivery and
performance by RRD of this Agreement and the consummation of the transactions
contemplated thereby have been duly and validly authorized by all necessary
action required on the part of RRD, and no other proceedings on the part of RRD
are necessary to authorize this Agreement or for RRD to perform its obligations
under this Agreement. This Agreement constitutes the lawful, valid and legally
binding obligations of RRD, enforceable in accordance with its terms, except as
the same may be limited by applicable bankruptcy, insolvency, reorganization,
moratorium or similar laws affecting the enforcement of creditors' rights
generally and general equitable principles regardless of whether such
enforceability is considered in a proceeding at law or in equity.

 

(3)

No Violation or Conflict. The execution, delivery and performance of this
Agreement and  the transactions contemplated thereby do not and will not (i)
violate, conflict with or result in the breach of any provision of the
organizational documents of RRD, (ii) conflict with or violate any law or
governmental order applicable to RRD or any of its assets, properties or
businesses to the extent that such conflicts, breaches, defaults or other
matters would not, individually or in the aggregate, reasonably be expected to
have a material adverse effect on RRD or a material adverse effect on the
Programs, or (iii) conflict with any terms of any other

9

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

contractual obligations with third parties, and will not enter into any
contractual obligations with any third party that would create a conflict with
the terms of this Agreement.

 

(4)

No Litigation. There are no actions by or against RRD pending before any
governmental authority or, to the knowledge of RRD, threatened to be brought by
or before any governmental authority, which would, individually or in the
aggregate, reasonably be expected to have a material adverse effect on RRD’s
ability to fulfill its obligations under this Agreement. There are no pending
or, to the knowledge of RRD, threatened actions, to which RRD is a party (or is
threatened to be named as a party) to set aside, restrain, enjoin or prevent the
execution, delivery or performance of this Agreement or the consummation of the
transactions contemplated hereby or thereby by any party hereto or thereto. RRD
is not subject to any governmental order (nor, to the knowledge of RRD, is there
any such governmental order threatened to be imposed by any governmental
authority) that would, individually or in the aggregate, reasonably be expected
to have a material adverse effect on RRD’s ability to fulfill its obligations
under this Agreement or a material adverse effect on any of the Programs.

 

B.

Eiger Representations and Warranties.  Eiger hereby represents and warrants to
RRD that, as of the Effective Date:

 

(1)

Organization. Eiger is a Delaware corporation, duly organized, validly existing
and in good standing under the laws of Delaware.

 

(2)

Authority and Validity. Eiger has all requisite corporate power and authority to
execute, deliver and perform its obligations under this Agreement and to
consummate the transactions contemplated thereby. The execution, delivery and
performance by Eiger of this Agreement and the consummation of the transactions
contemplated thereby have been duly and validly authorized by all necessary
action required on the part of Eiger, and no other proceedings on the part of
Eiger are necessary to authorize this Agreement or for Eiger to perform its
obligations under this Agreement. This Agreement constitutes the lawful, valid
and legally binding obligations of Eiger, enforceable in accordance with its
terms, except as the same may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting the enforcement of
creditors' rights generally and general equitable principles regardless of
whether such enforceability is considered in a proceeding at law or in equity.

 

(3)

No Violation or Conflict. The execution, delivery and performance of this
Agreement and  the transactions contemplated thereby do not and will not (i)
violate, conflict with or result in the breach of any provision of the
organizational documents of Eiger, (ii) conflict with or violate any law or
governmental order applicable to Eiger or any of its assets, properties or
businesses to the extent that such conflicts, breaches, defaults or other
matters would not, individually or in the aggregate, reasonably be expected to
have a material adverse effect on Eiger or a material adverse effect on the
Programs, or (iii) conflict with any terms of any other contractual obligations
with third parties, and will not enter into any contractual obligations with any
third party that would create a conflict with the terms of this Agreement.

 

(4)

No Litigation. There are no actions by or against Eiger pending before any
governmental authority or, to the knowledge of Eiger, threatened to be brought
by or before any governmental authority that would, individually or in the
aggregate, reasonably be expected to have a material adverse effect on Eiger’
ability to fulfill its obligations under this

10

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

Agreement. There are no pending or, to the knowledge of Eiger, threatened
actions to which Eiger is a party (or is threatened to be named as a party) to
set aside, restrain, enjoin or prevent the execution, delivery or performance of
this Agreement or the consummation of the transactions contemplated hereby by
any party hereto. Eiger is not subject to any governmental order (nor, to the
knowledge of Eiger, is there any such governmental order threatened to be
imposed by any governmental authority) that would, individually or in the
aggregate, reasonably be expected to have a material adverse effect on Eiger’
ability to fulfill its obligations under this Agreement or a material adverse
effect on the Programs.

8.

Regulatory Matters.

 

A.

Investigational New Drug (“IND”) Sponsor. Eiger shall be the sponsor for any IND
filed in relation to the Program(s) unless otherwise stated in the relevant
Project Agreement.

 

B.

Transfer of Regulatory Responsibilities. RRD and Eiger, where appropriate and
included in a Project Agreement, shall cooperate in the completion of a Transfer
of Regulatory Obligations Form (“TORO”) in conjunction with the relevant Project
Agreement. The TORO will be filed with the FDA by Eiger, where appropriate, or
as required by law or regulation. Any regulatory responsibilities not
specifically transferred in the TORO shall remain the responsibility of Eiger.
Nothing in this Agreement shall be construed to transfer from Eiger to RRD any
FDA or regulatory record-keeping requirements unless such transfer is
specifically provided for in the applicable `TORO.  [***]. In all cases, RRD
shall [***] ensure that any transfer of regulatory responsibilities will be
managed in such a way as to avoid disrupting the Project or presenting
unreasonable risk or inconvenience to patients and investigators.  

 

C.

Correspondence.  Each Party hereto acknowledges that Eiger, in its capacity as
IND Sponsor (except as otherwise stated in the relevant Project Agreement or any
relevant TORO), shall be solely responsible for responding to any regulatory
correspondence or inquiry regarding, or which would reasonably be expected to
affect, any of the Programs. Each Party shall, within [***] of receipt of any
FDA or other governmental or regulatory correspondence: (a) notify at least one
(1) of the DAC Members designated by RRD of any FDA or other governmental or
regulatory correspondence, inspection or inquiry regarding, or reasonably
expected to impact, any of the Programs; and (b) forward to the DAC copies of
any correspondence sent to or received from any regulatory or governmental
agency, including, but not limited to, FDA Form 483 notices and FDA refusal to
file, action or warning letters, to the extent they are relevant to any Program
or this Agreement, even if they do not specifically mention Eiger or RRD. To the
extent practicable, Eiger shall [***], but Eiger shall not be obligated to do so
if such action would require a delay beyond any time period permitted by
applicable law or regulations. [***]. In the event that RRD receives a request
or notification from a governmental authority with respect to the Programs, RRD
shall: (i) notify Eiger within twenty-four (24) hours of receipt of such request
or communication and (ii) to the extent practicable, submit any proposed
response to Eiger for review and approval; provided, that such approval shall
not be unreasonably withheld and shall not prevent RRD from complying with any
legal requirements or acting to avoid any civil or criminal liability. In the
event that a response to such request or notification should be filed by the IND
Sponsor, Eiger shall have such responsibility unless RRD has been designated as
IND Sponsor, or the responsibility has been delegated to RRD, pursuant to the
terms of the relevant Project Agreement.

 

D.

Inspections and Meetings.  Each Party agrees that, during an inspection by the
FDA or other regulatory authority concerning the Programs (“Inspections”), it
(the “Inspected Party”) will not

11

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

disclose to such agency any Confidential Information of the other Party without
first obtaining the consent of the other Party (which consent shall not be
unreasonably withheld or delayed), except to the extent that such Party may be
required by law to disclose such information and materials.

The Inspected Party shall be the primary Party responsible for arranging (unless
otherwise stated in writing by the other) and will allow the other Party to
reasonably participate, to the extent permitted, in any meetings with any
regulatory authority concerning any of the Programs. The Inspected Party shall
consult with the DAC prior to any such meetings and provide to the DAC for
review all relevant correspondence to date. During the Inspected Party’s
consultation with the DAC, the Inspected Party and the DAC shall discuss and
agree upon issues including, but not limited to, overall regulatory strategy,
proposed agendas, goals and objectives, preparation and attendees. The Inspected
Party shall provide prompt and reasonable prior notice of any such meetings to
at least one (1) of the DAC Members designated by the other Party, and shall,
upon a request from the other Party, and to the extent reasonably possible,
facilitate the attendance of at least one (1) of the DAC Members designated by
the other Party at any such meeting reasonably anticipated to pertain in a
material way to a Program. Following any meeting that pertains to a Program, but
that was not attended for any reason by at least one (1) of the DAC Members
designated by the other Party, the Inspected Party shall provide at least one
(1) of the DAC Members designated by the other Party with an oral summary of
that portion of the meeting relevant to such Program within [***] of such
meeting and a written summary of that portion within [***] of such meeting.

9.

Confidentiality.

 

A.

It is understood that during the course of this Agreement, RRD and Eiger may
each receive from the other Party data and information (including, without
limitation, computer programs, technical drawings, algorithms, know-how,
formulas, processes, ideas, inventions (whether patentable or not), schematics
and other technical, business, financial, customer and product development
plans, forecasts, strategies and information) that is either confidential or
proprietary to the disclosing Party. All such data and information, whether
written or verbal, tangible or intangible, made available, disclosed or
otherwise made known by a Party to the recipient Party (including its employees)
pursuant to this Agreement (including in connection with activities with respect
to any Project Agreement) shall (except as otherwise provided below) be
considered confidential and shall be considered the sole property of the
disclosing Party and shall hereinafter be referred to as “Confidential
Information.”   For clarity, all Eiger Information, Records, Reports, data and
results generated from the Program shall be Confidential Information of Eiger
for purposes of this Agreement and RRD shall be deemed the recipient Party of
such information that it actually receives or generates (notwithstanding the
fact that such information is generated and disclosed by RRD to Eiger).

 

B.

Confidential Information of the disclosing Party shall be used by the receiving
Party only for purposes of performing the receiving Party’s obligations or
exercising its rights hereunder. Each Party agrees that it will not reveal,
publish or otherwise disclose the Confidential Information of the other Party to
any third party without the prior written consent of the disclosing Party;
provided, however, that each of RRD and Eiger may disclose the other Party’s
Confidential Information to persons within their respective organizations and to
their respective contractors, consultants, attorneys, advisors and collaborators
that have a need to receive such Confidential Information in order to further
the purposes of this Agreement or any particular Project

12

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

Agreement and that are bound to protect the confidentiality of such Confidential
information pursuant to terms no less stringent than those described herein. RRD
and Eiger have or shall obtain agreements that impose at least comparable
confidentiality obligations as those contained in this Agreement with all
parties who are permitted access to the other Party’s Confidential Information
under this Agreement or any Project Agreement.

 

C.

The foregoing obligations shall not apply to Confidential Information to the
extent that it:

 

(1)

is, at the time of disclosure by the disclosing Party hereunder, or thereafter
becomes, generally available to the public other than as a result of a
disclosure by the receiving Party;

 

(2)

becomes available to the receiving Party on a non-confidential basis from a
third party source that is not prohibited from disclosing such information; or

 

(3)

was developed independently of any disclosure by the disclosing Party and
without access or reference to the disclosing Party’s Confidential Information
or was known to the receiving Party prior to its receipt from the disclosing
Party, in each case as shown by contemporaneous written evidence.

Notwithstanding the foregoing, a receiving Party may disclose specific
Confidential Information of the other Party to the extent that such disclosure
is required by law, regulation or valid court order to be disclosed; provided,
however, in the event that receiving Party or receiving Party’s representatives
become legally compelled to disclose any Confidential Information of the
disclosing Party, such receiving Party (a) will provide disclosing Party with
reasonable notice so that disclosing Party may seek a protective order or other
appropriate remedy or waive compliance with the provisions of the Agreement and
(b) will disclose only that portion of the Confidential Information that it is
advised by opinion of counsel (reasonably acceptable to disclosing Party) is
legally required (in accordance with any applicable protective order or other
order) and will endeavor to obtain assurance that confidential treatment will be
accorded the Confidential Information so furnished.

 

D.

These obligations of confidentiality, nondisclosure and non-use shall remain in
effect until [***] after the date of termination or expiration of this
Agreement.

10.

Ownership and Inventions.

 

A.

All data and information generated or derived by RRD as the result of Services
performed by RRD under this Agreement shall be and remain the exclusive property
of Eiger. Any inventions (whether patentable or not) and/or related patents that
may arise from or relate to such data and information described above or the
Services shall belong solely to Eiger. RRD hereby assigns and shall assign its
rights in all such data, information, inventions and/or related patents and
other intellectual property rights (collectively, “Eiger Program IP”) to Eiger
without compensation except for RRD’s reasonable time and expenses related to
any additional time or expenses required above and beyond the general assignment
provided in this paragraph.  RRD shall notify Eiger in writing of any and all
Eiger Program IP promptly after its conception, identification, development or
reduction to practice.   RRD agrees to take, and to cause its employees, agents,
consultants and permitted subcontractors to take, at Eiger’s reasonable request
and reasonable expense, all further acts reasonably required to evidence, effect
or perfect such assignment and transfer to Eiger and to obtain intellectual
property right protection for the Eiger Program IP.  

13

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

B.

RRD acknowledges that Eiger possesses certain inventions, processes, know-how,
trade secrets, improvements, other intellectual properties and other assets,
including, but not limited to, standard operating procedures (and related
documents), analytical methods, procedures and techniques, procedure manuals,
personnel data, financial information, computer technical expertise and
software, that have been developed by Eiger independently and outside the scope
of this Agreement, and that relate to Eiger’s business or operations and/or any
proprietary product or material of Eiger (collectively “Eiger’s Property”).
Eiger and RRD agree that any of Eiger’ Property shall be and remain the
exclusive property of Eiger.

 

C.

Eiger acknowledges that RRD possesses certain inventions, processes, know-how,
trade secrets, improvements, other intellectual properties and other assets,
including, but not limited to, standard operating procedures (and related
documents), analytical methods, procedures and techniques, procedure manuals,
personnel data, financial information, computer technical expertise and
software, that have been developed by RRD independently and outside the scope of
this Agreement, and that relate to RRD’s business or operations (collectively
“RRD’s Property”). Eiger and RRD agree that any of (i) RRD’s Property, (ii) any
improvements thereto that are used, improved, modified or developed by RRD
during the term of this Agreement outside of the conduct of the Services and
(iii) any RRD Improvements (as defined below) shall be and remain the exclusive
property of RRD.  As used herein, “RRD Improvements” shall mean any inventions,
processes, know-how, trade secrets, or improvements that (a) are conceived or
reduced to practice solely by RRD during the Term without the use of any Eiger’s
Property, (b) does not relate in any respect to any Eiger’s Property or any
proprietary product or material of Eiger, and (c) relate solely and specifically
to RRD’s Property.

 

D.

Notwithstanding the foregoing, if any RRD’s Property or RRD Improvement is
employed by, is embodies within, or otherwise materially useful or necessary to
use or to practice, use or otherwise exploit any Eiger Program IP, RRD shall be
deemed to have granted, and hereby grants, to Eiger a non-exclusive, worldwide,
royalty-free, fully-paid, sublicensable, perpetual license under such RRD’s
Property or RRD Invention solely to the extent necessary to practice, use or
exploit such Eiger Program IP.

11.

Publication.  Project results may not be published or referred to, in whole or
in part, by RRD without the prior express written consent of Eiger.  Neither
Party will use the other Party’s name in connection with any publication or
promotion without the other Party’s prior written consent. Notwithstanding the
above, neither Party will be restricted from using the other Party’s name in
filings or communications with the FDA, or other governmental or regulatory
agencies, when required to do so by such agencies or by applicable law or
regulation.  In the event that such disclosure is required as aforesaid, the
disclosing Party shall provide the other Party with notice beforehand and
coordinate with the other Party with respect to the wording and timing of any
such disclosure.

12.

Independent Contractor Relationship.  For the purposes of this Agreement, the
Parties are independent contractors and nothing contained in this Agreement
shall be construed to create any joint venture, principal and agent,
employer/employee or partnership relationship between RRD and Eiger, and the
Parties acknowledge and agree that RRD is acting as an independent contractor in
the performance of its obligations under this Agreement.  Each Party agrees that
it shall have no power or right to bind or obligate the other Party, other than
through the express terms of this Agreement that grant such power or right, and
neither Party shall hold itself out as having such authority.

14

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

13.

Indemnification.

 

A.

To the greatest extent permitted by applicable law:

 

(1)

Eiger shall indemnify, defend and hold harmless RRD and its affiliates and each
of their respective LLC members, officers, directors, employees, contractors,
agents, managers, successors and assigns (each, an "RRD Indemnified Party"),
from and against any and all claims, losses, costs, interest, awards, judgments,
fees (including reasonable fees for attorneys and other professionals), court
costs, liabilities, damages and expenses of any kind (including arising out of
physical injury) incurred by any RRD Indemnified Party (irrespective of whether
any such Indemnified Party is a party to the action for which indemnification
hereunder is sought) (hereinafter, "RRD Losses") to the extent resulting from or
arising out of any third party suits, claims, actions, proceedings,
investigations, litigation or demands arising from or in connection with: (a)
[***]; (b) [***]; or (c) [***] (i) [***] or (ii) [***].

 

(2)

RRD shall indemnify, defend and hold harmless Eiger and its affiliates and each
of their respective officers, directors, employees, contractors, agents,
successors and assigns (each, an "Eiger Indemnified Party"), from and against
any and all claims, losses, costs, interest, awards, judgments, fees (including
reasonable fees for attorneys), court costs, liabilities, damages and
expenses  (collectively, “Eiger Losses”) to the extent resulting from, or
arising out of any third party suits, claims, actions, proceedings,
investigations, litigation or demands arising from or in connection with this
Agreement, any Project Agreement or the Services contemplated herein relating
to, arising from or in connection with: (a) [***] or (b) [***] (i) [***] or (ii)
[***].  Notwithstanding the foregoing, RRD shall not be responsible for or
provide any indemnification for any Eiger Losses arising out of [***].

 

(3)

To the extent that the foregoing undertaking by RRD or Eiger may be
unenforceable for any reason, such Indemnifying Party shall make the maximum
contribution to the payment and satisfaction of any Loss that is permissible
under applicable law

 

(4)

To the extent that the foregoing undertaking by RRD or Eiger may be duplicated
by any other undertaking by RRD or Eiger under any other agreement, the Eiger
Indemnified Parties or RRD Indemnified Parties, as the case may be, shall be
entitled to only one recovery for the relevant Losses (and not entitled to any
duplicative recovery for the same Losses).

 

B.

Notice of Claims. Any Eiger Indemnified Party or RRD Indemnified Party (each an
“Indemnified Party”) that proposes to assert a right to be indemnified under
this Section shall notify RRD or Eiger, as applicable (the "Indemnifying
Party"), promptly after receipt of notice of commencement of any action, suit or
proceeding against such Indemnified Party (an "Indemnified Proceeding") in
respect of which a claim is to be made under this Section, or the incurrence or
realization of any Loss in respect of which a claim is to be made under this
Section, of the commencement of such Indemnified Proceeding or of such
incurrence or realization, enclosing a copy of all relevant documents, including
all papers served and claims made, but the omission to notify the applicable
Indemnifying Party promptly of any such Indemnified Proceeding or incurrence or
realization shall not relieve such Indemnifying Party from any liability that it
may have to such Indemnified Party under this Section or otherwise, except, as
to such Indemnifying Party's liability under this Section, to the extent, but
only to the extent, that such Indemnifying Party shall have been prejudiced by
such omission or delay in the defense of such claim.

15

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

C.

Procedure. The Indemnifying Party shall be entitled to participate in and assume
the defense of any Indemnified Proceeding, with counsel reasonably satisfactory
to the Indemnified Party, and, after notice to the Indemnified Party from the
Indemnifying Party of its election to assume the defense thereof, the
Indemnifying Party shall be responsible for all legal and other expenses
incurred by it in connection therewith; provided, that, if the Indemnified Party
shall have reasonably concluded that there may be one or more legal defenses
available to it which are different from or are in addition to those available
to the Indemnifying Party, or that such claim or litigation involves or could
have an effect upon matters beyond the scope of the indemnity agreement provided
in this Section 13, the Indemnifying Party shall not have the right to assume
the defense of such action on behalf of the Indemnified Party, and the
Indemnifying Party shall reimburse the Indemnified Party for the fees and
expenses of a single counsel retained by the Indemnified Party which are
reasonably related to the matters covered by the indemnity agreement in this
Section 13. The Indemnified Party shall fully cooperate with the Indemnifying
Party and its representatives in the investigation of any claim or lawsuit
related to the Services provided in this Agreement.  

 

D.

Settlement. Without the prior written consent of such Indemnified Party, such
consent not to be unreasonably withheld, such Indemnifying Party shall not
settle or compromise, or consent to the entry of any judgment in, any pending or
threatened Indemnified Proceeding, unless such settlement, compromise, consent
or related judgment (i) includes an unconditional release of such Indemnified
Party from all liability for Losses arising out of such claim, action,
investigation, suit or other legal proceeding, (ii) provides for the payment of
money damages as the sole relief for the claimant (whether at law or in equity),
(iii) involves no admission of fact adverse to the Indemnified Party or finding
or admission of any violation of law or the rights of any person by the
Indemnified Party, and (iv) is not in the nature of a criminal or regulatory
action. No Indemnified Party shall settle or compromise, or consent to the entry
of any judgment in, any pending or threatened Indemnified Proceeding (A) in
respect of which any payment would result hereunder, (B) which includes an
injunction that will adversely affect any Indemnifying Party, (C) which involves
an admission of fact adverse to the Indemnifying Party or a finding or admission
of any violation of law or the rights of any person by the Indemnifying Party,
or (D) which is in the nature of a criminal or regulatory action, without the
prior written consent of the Indemnifying Party, such consent not to be
unreasonably conditioned, withheld or delayed.

14.

Limitation of Liabilities.

 

A.

NEITHER PARTY NOR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, MEMBERS,
MANAGERS, EMPLOYEES, CONTRACTORS OR AGENTS SHALL HAVE ANY LIABILITY OF ANY TYPE
(INCLUDING, BUT NOT LIMITED TO, CONTRACT, NEGLIGENCE AND TORT LIABILITY) TO THE
OTHER PARTY FOR ANY SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE OR CONSEQUENTIAL
DAMAGES, INCLUDING, BUT NOT LIMITED TO, THE LOSS OF OPPORTUNITY, LOSS OF USE OR
LOSS OF REVENUE OR PROFIT IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT OR
THE SERVICES PERFORMED HEREUNDER, EVEN IF SUCH DAMAGES MAY HAVE BEEN
FORESEEABLE.  

 

B.

RRD EXPRESSLY DISCLAIMS ANY AND ALL LIABILITY TO EIGER FOR OR IN RESPECT OF ANY
CLAIM ARISING OUT OF ANY CONDITION CAUSED BY OR ALLEGEDLY CAUSED BY ANY
PHARMACEUTICAL OR BIOTECHNOLOGY PRODUCT OR DEVICE WHICH IS THE SUBJECT OF A
PROJECT AGREEMENT IN ACCORDANCE WITH THE PROVISIONS OF ANY PROJECT AGREEMENT.

16

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

C.

IN NO EVENT SHALL THE LIABILITY (INCLUDING, BUT NOT LIMITED TO, CONTRACT,
NEGLIGENCE AND TORT LIABILITY) OF RRD AND ITS DIRECTORS, OFFICERS, MEMBERS,
MANAGERS, EMPLOYEES, CONTRACTORS AND AGENTS UNDER THIS AGREEMENT EXCEED AN
AMOUNT EQUAL TO [***].

 

D.

NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 14 IS INTENDED TO OR
SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY
UNDER SECTION 13, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY
OBLIGATIONS IN ARTICLE 9 THAT ARE THE RESULT OF THE NON-INDEMNIFYING PARTY OR
BREACHING PARTY’S GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT.  

15.

Term and Termination.

 

A.

Termination of this Agreement.

 

(1)

Manner of Termination.  The term of this Agreement shall commence on the
Effective Date and shall continue until terminated in any of the following
manners:

 

(a)

this Agreement (or any individual Project Agreement) may be terminated by Eiger
without cause on [***]’ prior written notice to RRD (and such notice shall begin
the notice period for any Project Agreement then in effect);

 

(b)

this Agreement (or the applicable Project Agreement)may be terminated by either
Party for material breach by the non-terminating Party upon [***]’ written
notice specifying the nature of the breach, if such breach has not been
substantially cured within the [***] period (and such notice shall begin the
notice period for any Project Agreement then in effect);

 

(c)

in the event a Party makes an assignment for the benefit of creditors, appoints
or suffers appointment of a receiver or trustee over all or substantially all of
its property, files a petition under any bankruptcy or insolvency act or has any
such petition filed against it which is not discharged within [***] of the
filing thereof, then the other Party may terminate this Agreement effective
immediately upon written notice to such Party;

 

(d)

this Agreement (or the applicable Project Agreement)may be immediately
terminated by either Party upon written notice to the other Party in the event
that such Party has a good faith belief, after consultation with the other
Party, that : (1) the other Party has committed (or such Party has a good faith
belief that the other Party will commit) any significant action or inaction that
is in direct violation of any statute or regulation, FDA guideline, or GCP which
puts patient safety at risk; or (2) the continuation of any particular program
that is the subject of a Project Agreement currently in place raises significant
medical, scientific or safety concerns for patient safety; or

 

(e)

this Agreement (or the applicable Project Agreement) may be immediately
terminated by either Party upon written notice to the other Party in the event
that FDA or other regulatory authority takes any action to suspend or terminate
or withdraw approval of the clinical study under the Program subject to the
consequences of termination as described in this Agreement or any relevant
Project Agreement.

17

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

(2)

Effect on Project Agreements.  Unless otherwise agreed by the Parties, the
termination of this Agreement will result in the concurrent termination of all
Project Agreements hereunder, subject to any termination clauses contained
therein.

 

B.

Termination of Project Agreement.

 

(1)

The term of each Project Agreement shall be set forth in each applicable Project
Agreement and shall continue until terminated in accordance with the terms and
conditions contained herein or the specific termination provisions contained in
a particular Project Agreement. No termination of any Project Agreement shall
have any effect upon continuation of this Agreement or any other Project
Agreement except as otherwise agreed to by the Parties. Any written termination
notice shall identify the specific Project Agreement or Project Agreements that
are being terminated.

 

(2)

Upon the termination of any specific Project Agreement, RRD shall cease
performing any work not necessary for the orderly close out of the affected
Services or for the fulfillment of regulatory requirements in connection with
such orderly close out.  Using commercially reasonable efforts, RRD shall wind
down the affected Services as efficiently as possible with the intent of
mitigating any costs related to the wind down, the transfer of regulatory
responsibilities and the transfer of third-party contracts to Eiger or a third
party of Eiger’ choice.  RRD shall cooperate with Eiger in the orderly
transition of the Services to Eiger or a third party designated by Eiger
[***].  [***].  

 

(3)

RRD shall, upon request or as required by applicable laws, deliver to Eiger as
soon as reasonably possible, all data and materials provided by Eiger to RRD for
the conduct of the Services under the terminated Project Agreement(s), and all
data and information generated or derived by or on behalf of RRD, including,
without limitation, statistical data, all statistical reports, all data entries
and any other documentation produced as the result of Services performed by RRD
under the terminated Project Agreement(s), shall be delivered to Eiger upon
payment (not subject to a good faith dispute) to RRD for all Services completed
through the date of termination in accordance with the applicable Project
Agreement and the terms of this Agreement. RRD reserves the right to retain, at
its own cost and subject to the confidentiality provisions herein, one copy of
such materials and any Eiger Confidential Information (“RRD Retained
Documents”), for archival purposes solely to be used to satisfy regulatory
requirements relating to the Services performed by RRD for Eiger or to resolve
disputes regarding the Services.  Eiger agrees that the RRD Retained Documents,
if any, are not intended to serve as archives for Eiger and Eiger shall have no
expectation of access to such RRD Retained Documents.  RRD is under no
obligation to retain said documents for any specific period of time, except as
required by law.

 

(4)

Eiger shall, as soon as reasonably possible, deliver to RRD all RRD Confidential
Information provided by RRD to Eiger in connection with the Services under the
terminated Project Agreement(s). Eiger reserves the right to retain, at its own
cost and subject to the confidentiality provisions herein, (i) such RRD
Confidential Information as is subject to the license granted to Eiger under
Section 11(D) and (ii) one copy of such materials and any RRD Confidential
Information (“Eiger Retained Documents”), for archival purposes solely to be
used to satisfy regulatory requirements or to resolve disputes regarding the
Services. RRD agrees that the Eiger Retained Documents, if any, are not intended
to serve as archives for RRD and RRD shall have no expectation of access to such
Eiger Retained Documents. Eiger is

18

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

under no obligation to retain said documents for any specific period of time,
except as required by law.

 

(5)

Notwithstanding the foregoing, Confidential Information contained in system back
up files (e.g., computer backup tapes) need not be returned or destroyed so long
as they were created during the normal course of automatic system back up and
are maintained in confidence and not readily accessible to users.

 

(6)

Eiger shall [***], incurred to complete activities associated with the
termination, close out of the project or Services, and fulfillment of regulatory
obligations through the date of termination, unless otherwise agreed to by the
Parties in writing, but in all events, consistent with the payment terms agreed
to in each Project Agreement. In addition, Eiger will pay RRD for any
reasonable, non-cancelable out-of-pocket costs and expenses incurred in
providing the Services (including, without limitation, RRD pass-through costs
and expenses and third party termination fees), any reasonable out-of-pocket
costs and expenses directly incurred by RRD to close out the project, and any
amounts due and owing for Services conducted at the time of the termination
notice is received. If Eiger has pre-paid to RRD more than the amount due RRD in
the final invoice, then RRD agrees to refund such excess amount to Eiger.

 

C.

Consequences of Project Agreement Termination. Additional consequences of
termination (if any) for each Project Agreement shall be addressed separately in
each individual Project Agreement.

16.

Transition Following Termination.

 

A.

In the Event RRD Acts as IND Sponsor.  In the event RRD acts as IND Sponsor,
both Parties agree to make commercially reasonable efforts to, by the [***]
after the termination of this Agreement or any individual Project Agreement,
take all actions necessary to effect the transfer back to Eiger (or a third
party designated by Eiger) of, (i) the IND or that portion of the IND related to
the terminated Program, (ii) the regulatory files related to such terminated
Programs, and (iii) any and all documents or materials related to the terminated
Programs.  

 

B.

In the Event RRD Has Contracted for Third-Party Services on Eiger’ Behalf.  RRD
shall assign to Eiger or its designee, at Eiger’ expense and as of the
termination date of such Program, all of the Approved Contracts then in effect,
to the extent they relate solely to the terminated Program. Both Parties shall
use commercially reasonable efforts to cause the assignment of any
non-assignable subcontracting agreement or portion thereof relating to the
terminated Programs. If it is not successful in causing such assignment, RRD
shall act as Eiger’ agent, at Eiger’ request and reasonable expense, in
procuring all goods and services under such agreements until such time as Eiger
enters into alternative arrangements to procure such services, provided that
Eiger uses commercially reasonable efforts to enter into such alternative
arrangements as soon as possible. RRD shall provide copies of all such
subcontracting agreements to Eiger, at Eiger’ reasonable expense, in connection
with such transfer. RRD agrees to take such commercially reasonable actions as
Eiger may request in furtherance of the foregoing, at the expense of Eiger. Such
efforts shall not include any obligation for RRD to incur any out-of-pocket
costs that are not reimbursable by Eiger.

19

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

17.

Miscellaneous.

 

A.

Force Majeure. No delay by either Party to carry out or observe any of such
Party’s obligations under this Agreement (other than any payment obligation)
shall give rise to any claim against such Party or be deemed a breach of this
Agreement for the period of delay if such delay arises from an act of God, an
act of Government, or any other circumstance beyond the reasonable control of
the Party affected by the event of force majeure; provided that such Party gives
the other Party reasonable notice of such reason or cause and the obligation
affected, and uses good faith reasonable efforts to seek to perform the
obligation as soon as practicable.

 

B.

No Restrictions.  Nothing in this Agreement shall limit or restrict the right of
any RRD member, director, officer or employee of RRD or any member, director,
officer, or employee of any of its subsidiaries or its affiliates to engage in
any other business or to devote his or her time and attention to the management
or other aspects of any other business, whether of a similar or dissimilar
nature, nor limit or restrict the right of RRD or any of its affiliates to
engage in any other business or to render services of any kind to any other
entity; provided however that RRD and such member, director, officers and
employee complies with the confidentiality and non-use obligations set forth
herein.

 

C.

Non-Solicitation. During the term of this Agreement and for [***] thereafter,
neither Party will solicit or hire any employee or affiliate of the other Party
(or former employee or affiliate of the other Party) who has performed or is
performing Services under this Agreement.

 

D.

Notices.  Any notice, request, demand, waiver, consent, approval or other
communication which is required or permitted to be given to any Party shall be
in writing addressed to the Party at its address set forth below (provided that
each Party may change its address for receipt of notice by giving notice of such
change to the other Party) and shall be deemed given (i) when delivered to the
Party personally, (ii) when delivered by next business day delivery by a
nationally recognized courier service, or (iii) if sent by registered or
certified mail when received, provided postage and registration or certification
fees are prepaid and delivery is confirmed by a return receipt:

 

If to RRD:

J. Scott Tarrant

 

President

 

RRD International, LLC

 

7361 Calhoun Place, Suite 510

 

Rockville, MD  20855

 

Fax: [***]

 

 

With a copy to:

Raymond V. Lee, Esq.

 

Vice President, Legal Affairs

 

 

If to Eiger:

David Cory

 

Chief Executive Officer

 

Eiger BioPharmaceuticals, Inc.

 

2155 Park Boulevard

 

Palo Alto, CA  94306

 

20

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

E.

Arbitration.  Any controversy or claim arising out of, or relating to, this
Agreement or the breach thereof shall be finally settled by arbitration
administered by the American Arbitration Association (“AAA”) under its
Commercial Arbitration Rules (“AAA Rules”) and judgment on the award rendered by
the arbitrator shall be binding and may be entered in any court having
jurisdiction thereof. [***]  Notwithstanding the foregoing, either Party may
seek injunctive relief before any court of competent jurisdiction for a breach
of the confidentiality provisions of this Agreement or to preserve the status
quo pending arbitration.

 

F.

Governing Law. This Agreement shall be governed by, and construed in accordance
with, the laws of the State of Delaware, excluding its conflicts of law
provisions that may require the application of the laws of a different
jurisdiction.

 

G.

Amendment. The terms of this Agreement shall not be modified, amended, waived or
supplemented in any manner whatsoever except by a written instrument signed by
each of the Parties.

 

H.

Successors. Nothing expressed or implied herein is intended or shall be
construed to confer upon or to give to any person, other than the Parties, any
right, remedy or claim under or by reason of this Agreement or of any term,
covenant or condition hereof, and all the terms, covenants, conditions, promises
and agreements contained herein shall be for the sole and exclusive benefit of
the Parties and their successors and permitted assigns.

 

I.

Assignment. Neither Party may assign this Agreement or any of its rights or
obligations under this Agreement to any third party without the express, written
consent of the other Party, which consent shall not be unreasonably withheld or
delayed; provided, however, that either Party may assign this Agreement without
such consent to its successor or the acquirer of all or substantially all of its
assets or the assets to which this Agreement relates except in the event such
assignment would cause a conflict that would prevent the non-assigning Party
from entering into this Agreement.

 

J.

Counterparts. This Agreement may be executed in one or more counterparts, each
of which, when executed, shall be deemed an original but all of which taken
together shall constitute one and the same Agreement.

 

K.

Severability.  If any term or other provision of this Agreement is invalid,
illegal or incapable of being enforced by any rule of law or public policy, all
other conditions and provisions of this Agreement shall nevertheless remain in
full force and effect so long as the economic or legal substance of the
transactions contemplated hereby is not affected in a manner materially adverse
to either Party. Upon such determination that any term or other provision is
invalid, illegal or incapable of being enforced, the parties hereto shall
negotiate in good faith to modify this Agreement so as to effect the original
intent of the parties as closely as possible in an acceptable manner to the end
that the transactions contemplated hereby are fulfilled to the extent possible.

 

L.

Survival. The rights and obligations of Eiger and RRD which expressly survive
beyond  the effective date of termination (including, but not limited to,
Sections 4(C)(1), 4(F), 5(A), 9, 10, 11, 13, 14, 15(B), 16, 17(C), (D), (E) and
(F) shall survive the termination of this Agreement.  

 

M.

Entire Agreement.  This Agreement (including any attachments hereto and as may
be amended from time to time) and any Project Agreement contains the entire
understandings of the Parties

21

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

 

with respect to the subject matter herein, and supersedes all previous
agreements (oral and written), negotiations and discussions.

 

N.

Press Releases. Neither Party to this agreement shall issue any press release or
make any other public announcement concerning the terms of this Agreement, the
activities hereunder or the transaction between the Parties, without prior
review and written approval by the other party, except in the case of a press
release or governmental filing required by laws or regulations.

 

O.

Previous Agreements.  Concurrently upon the execution of this Agreement, the
following agreements shall be automatically terminated and any obligations
between the Parties thereunder shall be subsumed into this Agreement or relevant
Project Agreement (including payment obligations thereunder which shall be
reconciled with payment obligations hereunder), provided however, that any
confidential information disclosed by Eiger under any of the following
agreements shall be deemed Confidential Information pursuant to Section 9 of
this Agreement:

 

Agreement

Effective Date

Master Services Agreement

[***]

Work Order 2

[***]

Work Order 3

[***]

Work Order 4

[***]

Work Order 5

[***]

Change Order 1

[***]

Change Order 2

[***]

Change Order 2 - Amended and Restated

[***]

Change Order 3

[***]

Work Order 6

[***]

Change Order 1

[***]

Work Order 7

[***]

Work Order 8

[***]

Change Order 1

[***]

Change Order 2

[***]

Work Order 9

[***]

Change Order 1

[***]

Change Order 2

[***]

Work Order 10

[***]

Change Order 1

[***]

Work Order 11

 

LOA

[***]

LOA – Extension to 3/9/18

[***]

Amended and Restated WO 11

[***]

22

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

--------------------------------------------------------------------------------

 

 

Amended and Restated WO 11 – Amend 1

[***]

Amended and Restated WO 11 – Amend 2

[***]

Amended and Restated WO 11 – Amend 3

[***]

 

Notwithstanding anything herein to the contrary, the MSA shall remain in effect
for Work Order 1 and the following change orders, only For the purposes of RRD
continuing to provide ad-hoc, hourly consulting services for projects not
related to this PDA and any Project Agreements hereunder.

 

Work Order 1

[***]

Change Order 1

[***]

Change Order 2

[***]

Change Order 3

[***]

 

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date.

 

ACKNOWLEDGED, ACCEPTED AND AGREED TO:

 

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

 

23

[ *** ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.