Exhibit 10.1

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY ††) HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

PROJECT ADDENDUM

T HIS P ROJECT A DDENDUM (the “ Project Addendum ”) is made and entered into as of January 10, 2015 (the “ Effective Date ”) by and between PPD D EVELOPMENT , LP , a Delaware limited partnership, with its principal executive offices located at 929 North Front Street, Wilmington, North Carolina 28401 ( “PPD” ) and G ALECTIN T HERAPEUTICS , I NC . , a Nevada corporation with its principal executive offices located at 4960 Peachtree Industrial Boulevard, Suite 240, Norcross, Georgia 30071 ( “Sponsor” ).

WHEREAS, PPD and Sponsor entered into a certain Master Services Agreement (“ Agreement ”) dated January 8, 2015; and

WHEREAS, pursuant to Section 1.2 of the Agreement, the parties now wish to enter into this Project Addendum for the purposes of setting forth the responsibilities and obligations of the parties in regards to PPD providing services for Sponsor’s Phase II NASH-CX study, (the “Project”).

NOW, THEREFORE, for good and valuable consideration contained herein, the exchange, receipt and sufficiency of which are acknowledged, the parties agree as follows:

PPD shall perform those certain services set forth in the proposal submitted to Sponsor by PPD, which proposal is attached hereto as Exhibit A and incorporated herein by reference (“ Services ”).

2.1 - Compensation - For its performance of Services under this Project Addendum, PPD and Sponsor have established a budget of not to exceed $ 14,941,804.16 of which $ 8,866,490.71 shall be Direct Fees (as defined in the Agreement), and of which $ 6,075,313.45 shall be Pass Through Costs (as defined in the Agreement), with each of the Direct Fees and Pass Through Costs to be as determined under and limited by the Study Budget attached hereto as Exhibit B. PPD shall only invoice and Sponsor shall only be responsible for paying those Direct Fees and Pass Through Costs that are actually and reasonably incurred by PPD in the performance of the Services, and further subject to the amount limitation set forth herein unless otherwise agreed by the parties in writing. Should a material change in any of the key Study parameters , e.g., countries included, number or country distribution of sites, number of patients, number of CRF pages, number of statistical tables or listings, study timeline or protocol design justify an increase or decrease in the Study budget, PPD and Sponsor will negotiate in good faith changes to the Study Budget, which will be effective when summarized in writing and approved by Sponsor. PPD will promptly notify Sponsor in writing when it learns of facts or events that could be a material change in key Study parameters.

The Direct Fees are determined and limited by the quantities and the unit prices set forth in the Study Budget (less the consulting services discount as provided on page 9 thereof), as may be adjusted above, with payments of the Direct Fees billed and paid as set forth in Section 2.2. Sponsor and PPD recognize that the Direct Fees from time to time earned hereunder may be greater than or less than the payments then made under Section 2.2, and that in the event of early termination of the Services to be provided under this Project Addendum the Sponsor and PPD will negotiate in good faith the final payment or refund based on worked performed as compared to the Study Budget. Pass Through Costs are estimated and may vary as circumstances require but will be prudently managed by PPD so that they are reasonable and necessary to the conduct of the Study. PPD will promptly notify Sponsor in writing when it learns of facts or events that could cause the Pass Through Costs to exceed the sum of $6,075,313.45.

2.2 - Payment - PPD shall submit to Sponsor monthly invoice describing the Services performed on the Study, the Direct Fees due for such Services, and all Pass Through Costs paid by PPD, each as compared to the Study Budget so that Sponsor can track the level of expenditures against the Study Budget. For cash flow purposes, payments will be billed and remitted in accordance with the Payment Schedule attached hereto as Exhibit C, and PPD will provide information to Sponsor with each billing so that Sponsor can confirm that the amount billed is then due. Sponsor shall pay each monthly invoice within thirty (30) days of receipt of said invoice.

2.3 – Payments to PPD shall be made to:

Any changes to the payee information set forth above require a writing signed by PPD’s treasurer or chief financial officer.

PPD shall conduct the Study according to PPD’s Standard Operating Procedures (“SOPs”), which have been provided to Sponsor for review. These SOPs are subject to reasonable revision by PPD in which case PPD shall notify Sponsor of revision. If any such SOP revision can be reasonably expected to affect the budget or timelines for the Study, PPD shall submit to Sponsor revised cost estimates or timelines for the relevant Services which will become a part of this Project Addendum upon written approval by Sponsor. The current SOPs for conducting and monitoring clinical trials are available for review upon request by Sponsor.

Upon mutual agreement in writing, the parties may conduct the Study under Sponsor’s standard operating procedures. In such case, Sponsor shall provide prompt and reasonable training to any PPD personnel subject to such SOPs at Sponsor’s expense.

The term of this Project Addendum shall commence on the Effective Date and end upon the completion of Services unless otherwise terminated in accordance with the Agreement.

The terms and conditions of this Project Addendum and Exhibits hereto are hereby incorporated into and made a part of the Agreement. To the extent any terms contained in an Exhibit hereto conflict with this Project Addendum, the terms of this Project Addendum shall govern and control. In the event of any inconsistency between the Agreement, the Project Addendum, and the Protocol, the terms of the Protocol shall govern first, followed by the Project Addendum, and then by the Agreement unless otherwise specified.

Any changes to this Project Addendum or its Exhibits shall be documented by written Amendments executed by both parties and shall be attached hereto.

Each Party represents that its respective contact person set forth below shall have the authority to make all executive decisions regarding this Project Addendum. Any notice required or permitted to be given hereunder by either party hereunder shall be in writing and shall be deemed given on the date received if delivered personally or by fax or five (5) days after the date postmarked if sent by registered or certified U.S. mail, return receipt requested, postage prepaid to the following address:

This Project Addendum may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. Each party may execute this Agreement by facsimile transmission or in Portable Document Format sent by electronic means. Signatures of authorized signatories of the parties transmitted by facsimile or sent by electronic means in Portable Document Format shall be deemed to be original signatures, shall be valid and binding, and, upon delivery, shall constitute due execution of this Project Addendum.

IN WITNESS WHEREOF, this Project Addendum has been executed and delivered on the 6 ^th day of March, 2015, by their duly authorized officers as of the Effective Date.

Exhibit A

Proposal

(Specs/Assumptions and Statement of Services)

1.2 Clinical

1.3 Regulatory

PPD will appoint a global Regulatory Affairs Lead (RAL) to the study. This person will be Galectin’s regulatory contact and will have overall responsibility for the following:

PPD will also assign a local Country Approval Specialist (CAS) from each market involved in this study to support local submission activities and other regional assessments as required.

Local regulatory professionals will notify and frequently update the RAL regarding any regional issues such that the RAL can convey such information to Galectin without the need for Galectin to discuss with the local regulatory professionals directly.

PPD will review and provide regulatory intelligence input into study documents (e.g., protocol, investigator’s brochure) and locally translated documents (e.g., customized ICF, study drug labels) in order to minimize potential for questions during authority review and maximize successful outcome.

Assumptions

PPD assumes the following:

CTA Amendments/Notifications

††

1.4 Investigational Product Services

2

Indirect Costs

1.5 Quality Assurance

Assumptions

1.6 Pharmacovigilance/Medical Monitoring

Services Included*

Assumptions*

Senior Medical Officer (SMO) Services

Services Required:

Assumptions:

Please note: The SMO can only begin the review of the CTA or CTA-A after he/she receives a copy of the fully executed Contract that includes SMO Services.

Development Safety Update Reports (DSUR)

PPD understands that Galectin has requested that PPD prepare their clinical trial annual safety reports in the Development Safety Update Report (DSUR) format. Galectin will, in a timely manner, provide PPD with all requested data pertaining to the relevant investigational product(s) in English, including, but not limited to, data lock dates, submission schedules and safety information, including from relevant development/marketing partners.

Additional assumptions:

PPD will prepare DSURs in accordance with ICH-E2F and applicable EEA/US regulatory guidance, and the assumptions listed below:

PPD will provide drafts to Galectin, which may be in varying stages of completion based on the size of the report, for review. Galectin will return comments within five (5) working days. Due to the time-sensitive nature of each DSUR submission and in consideration of assigned resources, both PPD and CLIENT will endeavor to adhere to mutually agreed timelines. The final document should be approved by Galectin no later than four (4) business days prior to the earliest required submission date. PPD understands that Galectin will be responsible for submission of the aggregate report(s) to the appropriate regulatory agencies.

Pricing for DSURs depends upon several factors, including the volume of serious adverse reactions and size of the trials, as well as the format, volume and availability of the relevant data; therefore, these tasks are billed based on the actual time taken to complete the report. PPD has prepared a cost estimate based on our periodic safety update report (PSUR) experience; PPD has assumed 266 hours, on average, will be required including hours for preparation, analysis, writing and medical review of reports.

1.7 Pharmacovigilance Safety Reporting

Services Included*

Expedited and periodic safety report submissions.

Assumptions

1.8 Data Management

Assumptions

1.9 Electronic Data Capture (EDC)

Assumptions

1.10 Biostatistics

Assumptions

The proposed biostatistics work scope for the study includes the following statistical services and deliverables:

1.11 Medical Writing

Assumptions

1.13 Central Labs

Assumptions

General

Analysis

Supply/Kits

Transportation

1.14 Regulatory Inspections

Should Galectin require assistance from PPD in responding to a sponsor or investigative site regulatory inspection, Galectin and PPD will mutually agree the scope of services to be provided in writing. For these services Galectin will compensate PPD based on the unit pricing table below, unless the inspection occurs as a result of PPD’s inadequate service delivery or negligence. Each unit represents 8 hours of PPD effort to aid in Galectin response to the inspection(s).

1.15 Clinical Pharmacology (Pharmacokinetics)

Assumptions for Population PK Modeling

Assumptions for PK TLFs in the CSR

1.16 Estimated Timeline

2.2 Project Management and Team Meetings

2.3 Site Set Up

2.4 Ongoing Clinical Operations

2.7 Data Management/Programming Ongoing Activities

2.8 Pharmacovigilance

2.9 Medical Monitoring

2.10 Pharmacovigilance Safety Reporting

2.11 Biostatistics

2.12 Medical Writing

2.13 Quality Assurance

2.14 Regulatory Affairs

2.16 Clinical Pharmacology (Pharmacokinetics)

3 Central Labs Estimate

The Central Labs budget estimates are attached on the following pages.

PPD’s Central Lab, LLC Budget Estimate

Budget Summary Total Charge (USD)
GT-025
Laboratory Testing $ ††
Sample Management $ ††
Kits and Supplies $ ††
Clinical Trial Services Fees $ ††
Direct Costs Estimate: $ ††
Logistics (Pass-Through) Estimate: $ ††
Total Estimate: $ ††
Regional Budget Summary †† †† †† China
GT-025
Laboratory Testing $ †† $ †† $ †† $-
Sample Management $ †† $ †† $ †† $-
Kits and Supplies $ †† $ †† $ †† $-
Clinical Trial Services Fees $ †† $ †† $ †† $-
Regional Direct Costs Estimate: $ †† $ †† $ †† $-
Regional Logistics (Pass-Through) Estimate: $ †† $ †† $ †† $-
Regional Total Estimate: $ †† $ †† $ †† $-
Countries Sites Screened Subjects Enrolled Subjects Completed Subjects %
†† †† †† †† ††
†† †† †† †† ††
North America †† †† †† †† 100%
TOTAL †† †† †† ††

PPD’s Central Labs, LLC Budget Estimate
# Patients:
LONG CHEMISTRY PANEL: > 15 tests plus calculated parameters - including Amylase
Cholesterol, High Density Lipoprotein (HDL direct)
HEMATOLOGY PANEL (Auto Differential)
ROUTINE URINALYSIS W/MICROSCOPIC PANEL
Prothrombin Time
Prothrombin Time, INR
Partial Thromboplastin Time, Activated (APTT)
Drug Screen (Standard)
HIV 1&2 Antibody
HIV 1/2 Confirmation by Inno-Lia
†† †† †† †† †† †† †† †† ††
Sample Management
PK samples
Serum samples
Plasma Samples
ADA samples
Assumptions
Batch tested 3x weekly
Calculation - no charge
Batch tested 3x weekly
At screening
To be performed at PPD EU
To be performed at PPD EU
Batch tested weekly
Batch tested weekly
Batch tested weekly
Performed at GCL EU; Batch tested at 40 samples
Batched 20 specimen testing
Assumptions
†† Anti-GR-MD-02 Antibodies
Shipping Frequency
1:1 1:1 1:1 1:1 1:1
N/A 1:1 1:1 1:1 1:1 1:1 1:1 1:1 1:1 1:1 1:1 1:1
N/A 1:1
Shipping Frequency 1:1 1:1 1:1 1:1
Mode of Shipment
ambient ambient ambient ambient frozen frozen frozen ambient ambient ambient ambient ambient ambient frozen ambient ambient
frozen N/A frozen/batch analysis
Mode of Shipment frozen frozen frozen frozen
260 V2 Screening (Week -8) †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† ††
Screening (Week -8)
156 V3 Randomization (Week 1)
†† †† †† †† †† †† †† †† †† †† †† †† Randomization (Week 1) †† †† †† ††
147 V4 Week 12 †† †† †† †† †† †† †† †† †† †† †† †† Week 12 †† †† ††
138 V5 Week 26 †† †† †† †† †† †† †† †† †† †† †† †† Week 26 †† †† †† ††
129 V6 Week 38 †† †† †† †† †† †† †† †† †† †† †† †† Week 38 †† †† ††
117 V8 Week 52 †† †† †† †† †† †† Week 52 †† †† †† ††
156 V9 Follow-up / Termination †† †† †† †† †† †† †† †† †† †† †† †† †† Follow-up / Termination †† ††
1103 Total †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† Total †† †† †† ††
100%
†† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† †† ††
†† †† †† ††
0%††0 ††0 †† ††0 ††0 ††0 ††0 ††0 ††0 †† ††0 ††0 †† ††0 ††0 ††0 †† ††0 †† 0 0 0 0
Data Management Fee*
Assumes one transfer per month
transfer $ †† 24 $ †† €-†† €- $-
Estimated Logistics Management Fee shipment $ †† 1 $ †† €- †† €- $-
(Domestic)
as pass-through charges)
meeting $ †† 1 $ †† €- †† €- $-

PPD’s Central Labs, LLC
Budget Estimate
Estimate
US
EU
Screened: †† ††
Enrolled: †† ††
Completed: †† ††
NA & LATAM region
EMEA region
fx rate=USD/EUR 0.7944
fx rate=EUR/USD
1.4144
Laboratory Testing
Assumptions
UOM
NA&LA Unit Charge (USD)
No. Units
Total Charge (USD)
EU Unit Charge (Euro)
No. Units
Total Charge (EUR)
Total Charge (USD)
LONG CHEMISTRY PANEL: > 15 tests plus calculated parameters-including Amylase
result $†† †† $†† €†† †† €†† $††
Cholesterol, High Density Lipoprotein (HDL direct)
result $†† †† $†† €†† †† €†† $††
HEMATOLOGY PANEL (Auto Differential)
result $†† †† $†† €†† †† €†† $††
ROUTINE URINALYSIS W/MICROSCOPIC PANEL
result $†† †† $†† €†† †† €†† $††
Prothrombin Time
Batch tested 3x weekly
result $†† †† $†† €†† †† €†† $††
Prothrombin Time, INR
Calculation - no charge
result $†† †† $†† €†† †† €†† $††
Partial Thromboplastin Time, Activated (APTT)
Batch tested 3x weekly
result $†† †† $†† €†† †† €†† $††
Drug Screen (Standard)
At screening
result $†† †† $†† €†† †† €†† $††
HIV 1&2 Antibody
result $†† †† $†† €†† †† €†† $††
HIV 1/2 Confirmation by Inno-Lia
To be performed at PPD EU
result $†† †† $†† €†† †† €†† $††
Hepatitis B, Surface Antigen
result $†† †† $†† €†† †† €†† $††
Hepatitis C, Antibody
result $†† †† $†† €†† †† €†† $††
Hepatitis C Confirmation by Inno-Lia
result $†† †† $†† €†† †† €†† $††
Microglobulin, Alpha-2
Batch tested weekly
result $†† †† $†† €†† †† €†† $††
Haptoglobin
Batch tested weekly
result $†† †† $†† €†† †† €†† $††
Apolipoprotein AI
Batch tested weekly
result $†† †† $†† €†† †† €†† $††
ELF Testing: Hyaluronic Acid; PIIINP; TIMP-1 & ELF score
Performed at GCL EU; Batch tested at 40 samples
result $†† †† $†† €†† †† €†† $††
Fibrotest Score - sent to Biopredictive
result $†† †† $†† €†† †† €†† $††
Galectin-3
Batched 20 specimen testing
result $†† †† $†† €†† †† €†† $††
Analysis Total (per region):
$†† €†† $††
Sample Management
Assumptions
UOM
NA & LA Unit Charge (USD)
No. Units
Total Charge (USD)
EU Unit Charge (Euro)
No. Units
Total Charge (EUR)
Total Charge (USD)
PK samples
sample $†† †† $†† €†† †† €†† $††
Serum samples
For ELF test, Galectin-3 and others
sample $†† †† $†† €†† †† €†† $††
Plasma Samples
sample $†† †† $†† €†† †† €†† $††
ADA samples
Anti-GR-MD-02 Antibodies
sample $†† †† $†† €†† †† €†† $††
Storage
Assume two months
sample month $†† †† $†† €†† †† €†† $††
Sample Destruction Fee
sample $†† †† $†† €†† †† €†† $††
Sample Handling & Storage (per region): $†† €†† $††
Kits and Supplies
Assumptions
UOM
NA & LA Unit Charge (USD)
No. Units
Total Charge (USD)
EU Unit Charge (Euro)
No. Units
Total Charge (EUR)
Total Charge (USD)
Collection Kit Tier 2
Visits: Screening, V3, V4, V5, V6, V8, and V9
kit $†† †† $†† €†† †† €†† $††
Urine Cup W/Lid (25/sleeve)
Urine collection; assume 1 sleeve per site
sleeve $†† †† $†† €†† †† €†† $††

Pregnancy Test Kits Quick View
Urine pregnancy; assume 1 box per site
box $†† †† $†† €†† †† €†† $††
Box-Frozen Shipper-5lb. W/(1) Sample Bag Max/25 Samples (NA), 10lb. W/(2) Sample Bags Max/50 Samples (APAC)
Boxes for Frozen shipments
mailer $†† †† $†† €†† †† €†† $††
Box-Frozen Shipper-10lb.
Frozen PK samples - PPD CL US to PPD BioA: shipped quarterly
mailer $†† †† $††
Box-Frozen Shipper-20lb.
Frozen Serum samples - PPD CL US to referral lab: shipped quarterly
mailer $†† †† $††
Box-Frozen Shipper-20lb.
Frozen Plasma samples - PPD CL US to referral lab: shipped quarterly
mailer $†† †† $††
Box-Frozen Shipper-20lb.
Frozen ADA samples - PPD CL US to referral lab: shipped quarterly
mailer $†† †† $††
Cryo Box
Frozen samples - PPD CL US to referral lab
cryo box $†† †† $††
Bag-Large Single Cell W/Absorbent (Used w/cryboxes)
One per cryo box
bag $†† †† $††
Dry Ice < 44lb.
Frozen samples - PPD CL US to referral lab: 1 per shipment
dry ice $†† †† $††
Supplies Total (per region):
$†† €†† $††
Clinical Trial Services Fees
Assumptions
UOM
NA & LA Unit Charge (USD)
No. Units
Total Charge (USD)
EU Unit Charge (Euro)
No. Units
Total Charge (EUR)
Total Charge (USD)
Project Set-Up Fee
Study set-up
Project database $†† †† $†† €†† †† €†† $††
Site Initiation Fee
site $†† †† $†† €†† †† €†† $††
Project Management Fees
Includes 16 hours per month
month $†† †† $†† €†† †† €†† $††
Accessioning Fee
visit $†† †† $†† €†† †† €†† $††
Data Management Fee*
Assumes one transfer per month
transfer $†† †† $†† €†† †† €†† $††
Estimated Logistics Management Fee
shipment $†† †† $†† €†† †† €†† $††
Kick-off/Investigator Meeting Attendance Fee (Domestic)
Including Preparation, 1 day of attendance for 1 attendee, 1 day of travel (actual travel costs will be billed as pass-through charges)
meeting $†† †† $†† €†† †† €†† $††
Clinical Trial Services Total (per region)
$†† $††
Direct Costs Estimate per region:
$†† €†† $††
* If both PPD Central Labs and PPD Clinical/Data Management are awarded the opportunity this fee will be waived.

PPD’s Central Labs, LLC Budget Estimate

Exchange Rates:
SGD/USD ††
EUR/USD ††
USD/EUR ††
Global Logistics (Pass-Through)
Outbound, supplies to sites Inbound, Ambient/Refrig., sites to PPD Inbound, Frozen, sites to PPD Total Charge (USD)
Country Sites Unit Type Unit Cost Courier (Euro) Unit Cost (USD) # of Units Sub-total Unit Cost Courier (Euro) Unit Cost (USD) # of Units Sub-total Unit Cost Courier (Euro) Unit Cost (USD) # of Units Sub-total Dry ice and shippers
††
†† †† awb FedEx $†† †† $†† †† $†† †† $†† †† $†† †† $†† Transport only $††
†† †† awb DHL $†† †† $†† †† $†† †† $†† †† $†† †† $†† $††
Referral lab courier costs Frequency Courier Unit Type Unit Cost (Euro) Unit Cost (USD) # of Units Sub-total Comments Total Charge (USD)
Outbound, PK specimens from GCL US to PPD BioA Quarterly FedEx awb $†† †† $†† $††
Outbound, Plasma specimens from GCL US to referral lab Quarterly FedEx awb $†† †† $†† $††
Outbound, Serum specimens from GCL US to referral lab Quarterly FedEx awb $†† †† $†† $††
Outbound, ADA specimens from GCL US to referral lab Quarterly FedEx awb $†† †† $†† $††
TOTAL PASS THROUGH COSTS †† $†† †† $†† †† $†† †† $†† $††
* Transportation costs do not include Saturday delivery charges, taxes, tariffs, duties and fuel surcharge. This will be invoiced at the prevailing rate.
* Transportation fees are estimates only and based on primary cities.
* Client will be invoiced based on actual fees incurred.
* Laboratory kits may accommodate more than one patient visit/per inbound shipping box. For purposes of the estimate, 1 visit per inbound box has been assumed as average.
* Drive-away and trans-shipment to international port of departure may apply. Applicable customs fees charged as pass through cost.
* Inbound transport costs are based on Weekday priority overnight shipments.
* Outbound kits have standard transit time of 2-5 days. Overnight priority shipping provided with sponsor approval at additional shipping cost.

PPD’s Central Labs, LLC Budget Estimate

Terms and Conditions
GENERAL
Study set up will commence upon written acceptance of Contract and Central Laboratory Specification (CLS).
The costs contained within this Proposal are valid for 45 days from date of proposal.
The prices contained within this Proposal are estimates based upon information provided by the Sponsor. Cost will be revised if the Sponsor provides an amended protocol or updated information.
Access to PPD Clicks or Clicks for Sites is included at no charge, regardless of number of users.
All protocol materials will be archived for †† years from the end of PPD involvement. Requests for protocol materials will be shipped at the expense of the Sponsor/CRO.
SET-UP
PPD Global Central Labs requires 20 business days from signed CLS for study initiation. Study initiation is defined as the first Investigational site to receive specimen collection kits.
An acceleration fee will be applied, if study initiation is required within 20 business days of awarding the protocol. The acceleration fee will be invoiced at 25% of the set-up costs with a minimum charge of $5,000.
Sponsor requested changes to the fully executed CLS will result in additional charges to be determined based upon the complexity of the revisions.
PPD Global Central Labs has one global database that supports all regions within the study. Global set-up fees will be invoiced upon project initiation once database set-up activities are complete.
TRAINING/TRAVEL
If requested to attend a Kick off meeting or Investigator meeting, a fee of US$ 2,000.00 per day per meeting for attendance of PPD Central Labs presenter at one meeting including preparation, excluding travel expenses billed as pass through. This cost assumes a one day meeting with one day for travel. Each additional day will be US$1,000 per day. Sponsor request of technical attendees will be charged additional fees of US$ 2,000.00 per day, plus travel expenses.
Attendance at the investigator meeting via WebEx will be charged US$ 500.00 per meeting per attendee.
Site training via conference call for protocol specific laboratory procedures is available at sponsor’s request. This will be invoiced at US$ 200.00 per hour.
On site training visits to outline protocol specific laboratory procedures at the sponsor’s request, will be invoiced at a rate of US$ 750.00 per site visit, plus travel expenses.
TRANSPORTATION
Transportation fees are based on primary cities only.
Transportations costs do not include Saturday delivery charges, taxes, tariffs, duties and fuel surcharges. Sponsor will be invoiced at the prevailing rate.
Dry ice supply is included in the estimated cost of all inbound frozen shipments except for those shipments originating in the United States and ††. Pass-through charges will equal the actual courier charge plus dry ice if supplied.
Logistics Management Fee will be billed at 15% of the Indirect costs.
MODIFICATIONS
Any services requested by Sponsor (or sites) and not included in this cost estimate will be charged separately. Services rendered will be invoiced as performed and a Contract Modification will be issued.
Out of protocol testing will be invoiced per the unit price with an additional US$ 25.00 Project Management fee, per request.
Additional charges will apply for any off-cycle or expedited testing.
Specimens requiring off-hour technician/processing time, will be invoiced with an added service charge of US$ 65.00 per hour.
Any sample that is UTP (Unable To Perform) will be charged a Sample Handling fee.
A sample destruction fee will be invoiced for any sample that is required to be destroyed. This fee will be charged per sample destroyed.
Expedited shipping fees will be applied at US$ 150.00 per shipment with less then 5 business days notice, plus shipping costs.
Additional label sets provided at an additional fee of US$ 2.00 per set.
Additional requisition forms provided at an additional fee of US$ 1.50 per requisition.
Additional collection flow charts (CFC) provided at an additional fee of US$ 5.00 per chart.
Set up of additional sites will incur additional site initiation fees and other applicable charges.
Database modifications will be invoiced at $150 per hour.
Non-Standard Services for Data Management and Custom programming will be supplied upon request and billed at a programming rate of US$ 200.00 per hour for services included but not limited to:
a. Custom data file formats
b. Custom data management reports c. Data reconciliation requirements
Returned kit fee of US$ 4.00 each (break-down and disposal of kit contents) plus return shipping charges.
Hard copy reports will be invoiced at US$ 5.00 per report
Translation costs reflect the average cost to translate a typical manual. Translation costs for other documents besides the manual, will be charged to the client based on the actual translation fees plus 20%.
Lab Manuals will be supplied to all sites upon initiation as part of the study set-up. Amended or revised manuals will be supplied at US$ 30.00 each.
Kit Tier NA & LATAM EMEA China AsiaPac
Collection Kit Tier 1 $†† €†† $†† $††
Collection Kit Tier 2 $†† €†† $†† $††
Collection Kit Tier 3 $†† €†† $†† $††
Collection Kit Tier 4 $†† €†† $†† $††
Collection Kit Tier 5 $†† €†† $†† $††
This budget for central laboratory services is based upon protocol requirements provided at the time of the RFP and is an estimate only. PPD Central Labs will invoice Sponsor for actual services rendered and testing performed. Invoices may, therefore, differ from the Budget due to differences in actual services rendered versus those contained within this Budget

Exhibit B

Budget

PPD
Department/Activity Unit Type Total Hours NA Unit Cost NA (USD) # of Units NA Budget NA (USD) Total Hours EMEA Unit Cost EMEA (USD) # of Units EMEA Budget EMEA (USD) Total Budget (USD)
Project Management
GPD Consulting protocol ** ** ** ** ** ** ** ** **
Protocol Review protocol ** ** ** ** ** ** ** ** **
Review Data Validation Manual protocol ** ** ** ** ** ** ** ** **
Review CRF protocol ** ** ** ** ** ** ** ** **
Prepare CRF Completion Guidelines case book ** ** ** ** ** ** ** ** **
Project Familiarization & Initial Team Training protocol ** ** ** ** ** ** ** ** **
Develop Country Budget and Payment Schedule Template country ** ** ** ** ** ** ** ** **
ICF Local Customization - Review and Approve country ** ** ** ** ** ** ** ** **
ICF Local Customization - Review and Approve - Amendments country ** ** ** ** ** ** ** ** **
Review SAP (PPD or Client) plan ** ** ** ** ** ** ** ** **
Identify Third Party Vendors vendor ** ** ** ** ** ** ** ** **
Vendor Management - PPD Managed Vendors vendor month ** ** ** ** ** ** ** ** **
Develop and Negotiate Site Contract Language, Budget and Payment Schedule site ** ** ** ** ** ** ** ** **
Investigator Grant Payment Administration payment ** ** ** ** ** ** ** ** **
IND Safety Reports report ** ** ** ** ** ** ** ** **
Clinical Site Audits audit ** ** ** ** ** ** ** ** **
Final Analysis Review report ** ** ** ** ** ** ** ** **
Kick-off Meeting with Client meeting ** ** ** ** ** ** ** ** **
Investigator Meeting attendee ** ** ** ** ** ** ** ** **
Face to Face Client Meetings meeting ** ** ** ** ** ** ** ** **
Client Teleconferences teleconference ** ** ** ** ** ** ** ** **
Internal Team Meetings and Ongoing Training meeting ** ** ** ** ** ** ** ** **
Project Management - Start-up month ** ** ** ** ** ** ** ** **
Project Management - Enrollment month ** ** ** ** ** ** ** ** **
Project Management - Treatment month ** ** ** ** ** ** ** ** **
Project Management - Close Out month ** ** ** ** ** ** ** ** **
Study Newsletters newsletter ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
Site Intelligence and Activation
Project Familiarization & Initial Team Training protocol ** ** ** ** ** ** ** ** **
CTMS Central Setup protocol ** ** ** ** ** ** ** ** **
CTMS Country Setup country ** ** ** ** ** ** ** ** **
CTMS Site Implementation site ** ** ** ** ** ** ** ** **
ICF Local Customization country ** ** ** ** ** ** ** ** **
Management of Translation of Protocol, Investigator Brochure, ICF & Technical Documents translation ** ** ** ** ** ** ** ** ** Review of Translation of ICF translation ** ** ** ** ** ** ** ** **
Clinical Site Identification site ** ** ** ** ** ** ** ** **
Pre-Study Visit Waiver PSV waiver ** ** ** ** ** ** ** ** **
Site Evaluation Visits - Prep/Admin/Follow-up visit ** ** ** ** ** ** ** ** **
Site Evaluation Visits - Time on Site visit ** ** ** ** ** ** ** ** **
Site Evaluation Visits - Travel visit ** ** ** ** ** ** ** ** **
Collect and Verify Regulatory Docs site ** ** ** ** ** ** ** ** **
Local Ethics Submissions site ** ** ** ** ** ** ** ** **
Central Ethics Submissions - Country Specific country ** ** ** ** ** ** ** ** **
Develop and Negotiate Site Contract Language site ** ** ** ** ** ** ** ** **
Investigator Grant Payment Negotiation site ** ** ** ** ** ** ** ** **
Develop Site Budget and Payment Schedule study ** ** ** ** ** ** ** ** **
Legal Template Process Negotiation Activities study ** ** ** ** ** ** ** ** **
Negotiate CDA site ** ** ** ** ** ** ** ** **
Kick-off Meeting with Client meeting ** ** ** ** ** ** ** ** **
Client Teleconferences teleconference ** ** ** ** ** ** ** ** **
Internal Team Meetings and Ongoing Training meeting ** ** ** ** ** ** ** ** **
Site Intelligence and Activation Management month ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
Clinical Management
Prepare Monitoring Plan protocol ** ** ** ** ** ** ** ** **
Review Protocol protocol ** ** ** ** ** ** ** ** **
Review CRF protocol ** ** ** ** ** ** ** ** **
Prepare CRF Completion Guidelines case book ** ** ** ** ** ** ** ** **
Project Familiarization & Initial Team Training protocol ** ** ** ** ** ** ** ** **
Unblinded Project Familiarization & Initial Team Training protocol ** ** ** ** ** ** ** ** **

Department/Activity Unit Type Total Hours NA Unit Cost NA (USD) # of Units NA Budget NA (USD) Total Hours EMEA Unit Cost EMEA (USD) # of Units EMEA Budget EMEA (USD) Total Budget (USD)
Develop Country Budget and Payment Schedule Template country ** ** ** ** ** ** ** ** **
Design Master ICF protocol ** ** ** ** ** ** ** ** **
ICF Local Customization - Amendments country ** ** ** ** ** ** ** ** **
Review of Site-Specific ICF Post EC - Amendments site ** ** ** ** ** ** ** ** **
IRB/EC Annual Renewals site ** ** ** ** ** ** ** ** **
Collect and Verify Reg Docs - Amendments site ** ** ** ** ** ** ** ** **
Investigator Brochure - Annual Update to Ethics Committee site year ** ** ** ** ** ** ** ** **
Amendments - Management of Translation of Protocol, Investigator Brochure, ICF & Technical Documents translation ** ** ** ** ** ** ** ** **
Amendments - Review of Translation of ICF translation ** ** ** ** ** ** ** ** **
Clinical Site Identification site ** ** ** ** ** ** ** ** **
Site Evaluation Visits - Prep/Admin/Follow-up visit ** ** ** ** ** ** ** ** **
Site Initiation Visits - Prep/Admin/Follow-up visit ** ** ** ** ** ** ** ** **
Site Initiation Visits - Time on Site visit ** ** ** ** ** ** ** ** **
Site Initiation Visits - Travel visit ** ** ** ** ** ** ** ** **
Interim Monitoring Visits - Prep/Admin/Follow-Up visit ** ** ** ** ** ** ** ** **
Interim Monitoring Visits - Time on Site visit ** ** ** ** ** ** ** ** **
Interim Monitoring Visits - Travel visit ** ** ** ** ** ** ** ** **
Site Management site month ** ** ** ** ** ** ** ** **
Unblinded Site Management site month ** ** ** ** ** ** ** ** **
Annual Investigator File Audits file audit ** ** ** ** ** ** ** ** **
Vendor Management - PPD Managed Vendors vendor month ** ** ** ** ** ** ** ** **
Develop and Negotiate Site Contract Language, Budget and Payment Schedule site ** ** ** ** ** ** ** ** **
Investigator Payment Administration payment ** ** ** ** ** ** ** ** **
Management of Non-Drug Trial Supplies shipment ** ** ** ** ** ** ** ** **
Clinical Site Audits audit ** ** ** ** ** ** ** ** **
In-house CRF Review CRF page ** ** ** ** ** ** ** ** **
Query Resolution query ** ** ** ** ** ** ** ** **
Unblinded Drug Accountability Visits - Prep/Admin/Follow-up visit ** ** ** ** ** ** ** ** **
Unblinded Drug Accountability Visits - Time on Site visit ** ** ** ** ** ** ** ** **
Unblinded Drug Accountability Visits - Travel visit ** ** ** ** ** ** ** ** **
Site Closeout Visits - Prep/Admin/Follow-up visit ** ** ** ** ** ** ** ** **
Site Closeout Visits - Time on Site visit ** ** ** ** ** ** ** ** **
Site Closeout Visits - Travel visit ** ** ** ** ** ** ** ** **
Kick-off Meeting with Client meeting ** ** ** ** ** ** ** ** **
Unblinded Kick-off Meeting with Client meeting ** ** ** ** ** ** ** ** **
Investigator Meeting attendee ** ** ** ** ** ** ** ** **
Unblinded Investigator Meeting attendee ** ** ** ** ** ** ** ** **
Face to Face Client Meetings meeting ** ** ** ** ** ** ** ** **
Client Teleconferences teleconference ** ** ** ** ** ** ** ** **
Internal Team Meetings and Ongoing Training meeting ** ** ** ** ** ** ** ** **
Unblinded Internal Team Meetings and Ongoing Training meeting ** ** ** ** ** ** ** ** **
CRA Team Meetings meeting ** ** ** ** ** ** ** ** **
Unblinded CRA Team Meetings meeting ** ** ** ** ** ** ** ** **
Protocol Inquiry Forms Management PIF ** ** ** ** ** ** ** ** **
Clinical Team Management month ** ** ** ** ** ** ** ** **
Unblinded Clinical Team Management month ** ** ** ** ** ** ** ** **
Study Newsletters newsletter ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
Global Clinical Supplies
Project Setup protocol ** ** ** ** ** ** ** ** **
Identify, Select and Negotiate Contracts with Clinical Supply Vendors vendor ** ** ** ** ** ** ** ** **
Label Text Development label ** ** ** ** ** ** ** ** **
Label Text Translation Coordination country ** ** ** ** ** ** ** ** **
Clinical Supply Forecasting forecast ** ** ** ** ** ** ** ** **
Monitor/Track Study Progress, Inventory Levels and Communication with Team/Sponsor month ** ** ** ** ** ** ** ** **
Final Drug Accountability and Destruction randomized patient ** ** ** ** ** ** ** ** **
Kick Off Meeting meeting ** ** ** ** ** ** ** ** **
Depot Management depot month ** ** ** ** ** ** ** ** **
Distribution Management shipment ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
IVRS
Base System Set-up protocol ** ** ** ** ** ** ** ** **
Code Break Module protocol ** ** ** ** ** ** ** ** **
Confirm Receipt Module protocol ** ** ** ** ** ** ** ** **
Randomization Module protocol ** ** ** ** ** ** ** ** **
Screening Module protocol ** ** ** ** ** ** ** ** **

Department/Activity Unit Type Total Hours NA Unit Cost NA (USD) # of Units NA Budget NA (USD) Total Hours EMEA Unit Cost EMEA (USD) # of Units EMEA Budget EMEA (USD) Total Budget (USD)
Medical Writing Project Maintenance month ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
QA
Clinical QA - Project Familiarization & Initial Team Training protocol ** ** ** ** ** ** ** ** **
Clinical QA - Clinical Investigator Site Audit audit ** ** ** ** ** ** ** ** **
Clinical QA - Project Support month ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Investigator Files Set-up site ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Investigator File Maintenance site month ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Investigator Files Archiving and Transfer site ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Unblinded Investigator Files Set-up site ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Unblinded Investigator File Maintenance site month ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Unblinded Investigator Files Archiving and Transfer site ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Country File Set-up country ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Country File Maintenance month ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Country File Archiving and Transfer country ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Central File Set-up protocol ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Central File Maintenance month ** ** ** ** ** ** ** ** **
Information Governance & Compliance - Central File Archiving and Transfer protocol ** ** ** ** ** ** ** ** **
Clinical Supplies QA - Project Agreements study ** ** ** ** ** ** ** ** **
Clinical Supplies QA - Project Support study ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
Regulatory Affairs
Clinical Trial Application/Authorization - Country Specific Submissions country ** ** ** ** ** ** ** ** **
Clinical Trial Application/Authorization - Variations and Amendments country ** ** ** ** ** ** ** ** **
Clinical Trial Application/Authorization - Management month ** ** ** ** ** ** ** ** **
Clinical Trial Application/Authorization - Annual/Progress Reports report ** ** ** ** ** ** ** ** **
Registration of Clinical Trials - Initial protocol ** ** ** ** ** ** ** ** **
Registration of Clinical Trials - Maintenance month ** ** ** ** ** ** ** ** **
Regulatory Review of Clinical Trial Labeling protocol ** ** ** ** ** ** ** ** **
Regulatory Compliance Review site ** ** ** ** ** ** ** ** **
Regulatory Compliance Review - Amendments site ** ** ** ** ** ** ** ** **
Safety Report Submissions submission ** ** ** ** ** ** ** ** **
Notification of End of Trial (Health Authority) protocol ** ** ** ** ** ** ** ** **
Kick-off Meeting with Client meeting ** ** ** ** ** ** ** ** **
Client Teleconferences teleconference ** ** ** ** ** ** ** ** **
Internal Team Meetings and Ongoing Training meeting ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
Clinical Pharmacology (PK)
Clean and Format Bioanalytical and CRF Data for NONMEM Datasets - POP study ** ** ** ** ** ** ** ** **
Project Setup - POP study ** ** ** ** ** ** ** ** **
Produce/PK Input to Population PKPD Analysis Plan - POP plan ** ** ** ** ** ** ** ** **
Generation of NONMEM datasets - POP dataset ** ** ** ** ** ** ** ** **
Generation of PKPD Datasets - NCA analysis dataset ** ** ** ** ** ** ** ** **
Generation of PKPD TLFs - NCA PKPD TLF set ** ** ** ** ** ** ** ** **
Population PK Analysis, Covariate Analysis, Model Evaluation - POP analyte ** ** ** ** ** ** ** ** **
Produce Population PKPD Study Report - POP report ** ** ** ** ** ** ** ** **
PK Project Team Meetings - POP month ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
EDC
EDC Project Set-up protocol ** ** ** ** ** ** ** ** **
EDC Study Closeout protocol ** ** ** ** ** ** ** ** **
Internal Team Meetings and Ongoing Training meeting ** ** ** ** ** ** ** ** **
Sub Total ** ** ** ** **
Total Direct Costs ** ** **
Consulting Services Discount ** ** **
Total Discounted Direct Costs ** ** 8,866,490.71
Pass Through Costs
BioA Quote report ** ** ** ** ** ** ** ** **
Central Laboratory Fees protocol ** ** ** ** ** ** ** ** **
Central Labs Quote EMEA report ** ** ** ** ** ** ** ** **
Clinical Site Audit - Travel audit ** ** ** ** ** ** ** ** **
Data Safety Monitoring Board Meetings meeting ** ** ** ** ** ** ** ** **

Department/Activity Unit Type Total Hours NA Unit Cost NA (USD) # of Units NA Budget NA (USD) Total Hours EMEA Unit Cost EMEA (USD) # of Units EMEA Budget EMEA (USD) Total Budget (USD)
EDC CD Building Material site ** ** ** ** ** ** ** ** **
Face to Face Client Meetings - Travel attendee ** ** ** ** ** ** ** ** **
Host Investigator Meeting study ** ** ** ** ** ** ** ** **
Importation costs for Supplies study ** ** ** ** ** ** ** ** **
Interim Monitoring Visits - Travel visit ** ** ** ** ** ** ** ** **
Investigator Fees patient ** ** ** ** ** ** ** ** **
IRB/EC Fees site ** ** ** ** ** ** ** ** **
IVR - Courier Charges for PIN Packets site user ** ** ** ** ** ** ** ** **
IVR - System Translations & Voice Recordings translation per language ** ** ** ** ** ** ** ** **
IVR - Telephone Line Charges call ** ** ** ** ** ** ** ** **
Kick-off Meeting With Client - Travel attendee ** ** ** ** ** ** ** ** **
Management of Packaging and Labeling packaging run ** ** ** ** ** ** ** ** **
Medidata Rave Services site month ** ** ** ** ** ** ** ** **
Site Closeout Visits - Travel visit ** ** ** ** ** ** ** ** **
Site Evaluation Visits - Travel visit ** ** ** ** ** ** ** ** **
Site Initiation Visits - Travel visit ** ** ** ** ** ** ** ** **
Study Drug Label Text Translations Fees protocol ** ** ** ** ** ** ** ** **
Third Party Depot Costs protocol ** ** ** ** ** ** ** ** **
Translation of various documents (excluding protocol) document ** ** ** ** ** ** ** ** **
Unblinded Drug Accountability Visits - Travel visit ** ** ** ** ** ** ** ** **
Total Pass Throughs ** ** **
Total Study Costs ** ** 14,941,804.16
Should Galectin Therapeutics, Inc. require assistance from PPD in responding to a Sponsor or investigative site regulatory inspection, Galectin Therapeutics, Inc. and PPD will mutually agree the scope of services to be provided in writing. For these services Galectin Therapeutics, Inc. will compensate PPD based on the unit pricing table below, unless the inspection occurs as a result of PPD’s inadequate service delivery or negligence. Each unit represents 8 hours of PPD effort to aid in Galectin Therapeutics, Inc.’s response to the inspection(s).
Unit Cost NA (USD) Unit Cost EMEA (EUR) Unit Cost APAC (USD) Unit Cost LA (USD)
Regulatory Inspection of Sponsor - 8 Hour Unit $** $** $** $**
Inspection of Site - 8 Hour Unit $** $** $** $**
*Inspection costs will be converted to the contract currency at the time of invoicing.
** The units and unit prices for the following service areas represent global units and the services associated with these units will be performed utilizing PPD’s global resource pool: IVRS, Data Management, Pharmacovigilance, Biostatistics, Medical Writing, Regulatory Affairs, Writing and Editorial Services, Electronic Data Capture.
This cost estimate is based upon the estimated study timeline included in PPD’s proposal dated 16 Dec 2014. Should there be a subsequent change to the estimated study timeline, PPD will apply resulting inflation as appropriate

MASTER SERVICES AGREEMENT

T HIS M ASTER S ERVICES A GREEMENT (the “Agreement” ) is effective as of 8 January, 2015 (the “Effective Date” ) by and between PPD D EVELOPMENT , L.P. , a Delaware limited partnership, with its principal executive offices located at 929 North Front Street, Wilmington, North Carolina ( “PPD” ) and G ALECTIN T HERAPEUTICS , I NC . , a Nevada corporation with its principal executive offices located at 4960 Peachtree Industrial Boulevard, Suite 240, Norcross Georgia 30071 ( “Sponsor” ).

WHEREAS, Sponsor is engaged in the development, manufacture, distribution and sale of pharmaceutical products; and

WHEREAS, PPD is a clinical research organization engaged in the business of managing clinical research programs and providing clinical development and other related services; and

WHEREAS, Sponsor may wish to retain the services of PPD from time to time to perform clinical development services in connection with certain clinical research programs Sponsor is conducting (individually, a “Project” ), in which case the terms and conditions for each such Project shall be set forth in a project addendum to be attached to this Agreement and incorporated herein by reference (individually, a “Project Addendum” and collectively, the “Project Addenda” ); and

WHEREAS, PPD is willing to provide such services to Sponsor in accordance with the terms and conditions of this Agreement and the attached Project Addenda.

NOW, THEREFORE, for good and valuable consideration contained herein, the exchange, receipt and sufficiency of which are acknowledged, the parties agree as follows:

1.1 Services to be Provided by PPD . PPD hereby agrees to provide to Sponsor the services identified and described in the Services section of each Project Addendum attached to this Agreement (the “Services” ). PPD shall perform the Services for each Project set forth in the applicable Project Addendum in compliance with (i) the protocol for the Project ( “Protocol” ), which may be attached to and as amended or updated from time to time, and made a part of, the applicable Project Addendum, (ii) the terms and conditions of this Agreement, (iii) the terms and conditions of the applicable Project Addendum and Sponsor’s written instructions, (iv) PPD’s standard operating procedures ( “SOPs” ), which will be available for review upon written request, and (v) all applicable laws, rules and regulations. Sponsor agrees that PPD is responsible only for those Services set forth on a properly executed Project Addendum.

1.2 Project Addendum . In the event that the parties hereto shall reach agreement with respect to the provision of Services for a Project, PPD and Sponsor shall execute a Project Addendum evidencing such Services. Each Project Addendum shall be attached to this Agreement and incorporated into and made a part of this Agreement by reference, and each such Project Addendum and this Agreement shall constitute the entire agreement for the applicable Project. To the extent any terms set forth in a Project Addendum conflict with the terms set forth in this Agreement, the terms of this Agreement shall control unless otherwise specifically set forth in the Project Addendum.

1.3 Mutual Cooperation . Sponsor and PPD will each cooperate with the other party in providing reasonably requested information to the other party, taking action and executing documents, as appropriate, to achieve the objectives of this Agreement and any Project Addendum executed under this Agreement. Sponsor acknowledges and agrees that PPD’s performance under this agreement is dependent on Sponsor and Sponsor’s representatives

timely and effective cooperation with PPD. Accordingly, Sponsor acknowledges that any delay by Sponsor to provide information information necessary to PPD to meet an obligation or deadline may result in PPD receiving an extension to meet an obligation to meet an obligation or schedule deadline or in Sponsor having to pay additional fees in order for PPD to meet a specific obligation or deadline despite the delay. In addition, PPD shall not be responsible for any delays due to (1) Sponsor or its agents, employees and contractors other than PPD, (2) any third party except for those who have been selected by PPD and research sites, (3) a force majeure event, or (4) any other factors outside of the direct and reasonable control of PPD. In the event of any such delays, the study timelines will be revised accordingly. Sponsor and PPD each shall comply with all applicable laws, rules and regulations governing the performance of its obligations hereunder and the subject matter of this Agreement.

1.4 Serious Adverse Event and Medical Management Plan . Notwithstanding anything to the contrary herein, in the event PPD and Sponsor agree upon a serious adverse event and medical management plan relating to a specific Project (“SMMP”), the parties shall comply with the terms and conditions of any such SMMP. In the event of any conflict between the terms and conditions of the SMMP and the relevant Project Addendum, the terms and conditions of the SMMP shall control. Sponsor shall be responsible for any additional costs associated with compliance with the SMMP, which will be captured in an amendment to the applicable Project Addendum.

1.5 Patient Enrollment . The parties agree that enrollment numbers are good faith estimates and that various factors outside of PPD’s control can affect the rate of enrollment. PPD shall exercise all reasonable efforts to meet such enrollment estimates, but cannot guarantee that enrollment numbers or enrollment timelines will be met. The Parties agree that incentives around enrollment based milestones may be addressed in an applicable Project Addendum.

1.6 Final Protocol . Subject to section 9.2 of this Agreement PPD shall not be liable or responsible for the final review, approval, adoption and content of the Protocol.

1.7 PPD Representations and Warranties . PPD represents and warrants to Sponsor that:

a. It is authorized to enter into this Agreement and that its execution, delivery and performance of this Agreement will not conflict with or constitute a default under any other agreement to which it is a party or by which its assets are bound;

b. All aspects of PPD’s facilities which may be used in the performance of any Services, including without limitation the databases to be used by PPD for the tracking, handling, recording, reporting and transmitting of data generated during the Projects have been fully verified and validated according to applicable industry standards;

c. It is not a party to any agreement that would prevent it from fulfilling its obligations under this Agreement and that during the term of this Agreement it will not enter into any agreement to provide services that would in any way prevent it from providing the Services contemplated under this Agreement;

d. It has the experience, capability and resources, including but not limited to sufficient personnel and supervisors to perform the Services under any Project Addenda in a competent manner and that it shall at all times devote the necessary personnel and supervisors to perform the Services in a competent manner; and

e. It will provide Services and conduct all activities pursuant to this Agreement in accordance with all applicable laws, regulations and applicable guidance documents, including without limitation, 21 C.F.R. § 312 and the International Conference on

Harmonisation Good Clinical Practice Guidelines and including all requirements on clinical research organizations, including as designees of trial sponsors that relate to Services provided hereunder.

2.1 Charges for Services . Sponsor shall pay PPD for all Services performed under this Agreement and any Project Addendum ( “Direct Fees” ) in accordance with the rates for such Services set forth in such Project Addendum, including any cap in fees agreed upon by the parties and identified in the Project Addendum. Sponsor shall also reimburse PPD for all out-of-pocket expenses incurred in connection with the performance of the Services with respect to a Project, including, without limitation, investigator grants and fees, travel expenses, shipping and postage costs, copying and printing fees, copyright fees, third party drug storage and distribution fees, required Institutional Review Board or similar board or committee fees, and other “pass through” expenses reasonably expected to be incurred in connection with performing the Services to the extent such expenses have been approved by Sponsor in advance (collectively, the “Pass Through Costs” ). Except as otherwise expressly provided in a Project Addendum, PPD shall submit to Sponsor for each Project a monthly invoice describing the Services performed on such Project, the Direct Fees due for such Services, and all Pass Through Costs paid by PPD. Sponsor shall pay each invoice within thirty (30) days of receipt of said invoice. If payment is not received by PPD within such thirty-day period, PPD shall provide notice to Sponsor in writing (e-mail is sufficient) of such unpaid invoice. Should Sponsor fail to make payment to PPD on such unpaid amounts within ten (10) days of Sponsor’s receipt of such written notice, Sponsor’s nonpayment thereof shall be considered a default. PPD shall have no obligation to pay Subcontractor (as defined in Section 14.11) costs, vendor costs, or investigator grant payments to any Subcontractor, vendor or investigator site (the “Site” ) for conduct of services by such Site related to a Project until PPD has received payment of such Pass Through Costs from Sponsor. Notwithstanding anything to the contrary contained herein, Sponsor acknowledges and agrees that certain vendor and Subcontractor contracts, including without limitation, contracts for investigator meetings and patient recruitment services, must be advanced and paid up front by Sponsor. PPD shall be under no obligation to incur any such vendor or Subcontractor fees until such fees are received from Sponsor. In addition, all investigator grants, if applicable and if approved in advance by Sponsor, shall be advanced by Sponsor at timeframes mutually agreed upon by the parties.

2.2 Payment after Termination . Upon termination of any Project Addendum or this Agreement pursuant to Section 3 below, Sponsor shall pay PPD all Direct Fees and Pass Through Costs for all Services, and any portion of Services, performed through the termination date. In addition, Sponsor shall reimburse PPD for all future non-cancelable obligations (where such obligations were reasonably created as a result of a Project being authorized by Sponsor and were approved in advance by Sponsor). Any funds held by PPD which are unearned shall be returned to Sponsor within sixty (60) days following conclusion of the Project including any wind down services, as long as no further funds are due to PPD from Sponsor are outstanding. Sponsor acknowledges that certain services of PPD require greater utilization of resources at the outset such that compensation for such services based on a percentage of milestones completed prior to PPD fully completing the milestones would work to the detriment of PPD. Accordingly, the parties agree that in the event of early termination that PPD shall be entitled to compensation for all completed and partially completed Services on a time and materials basis according to a calculation agreed upon by both parties.

2.3 Pre-Execution Services . In the event Sponsor requests PPD to begin providing the Services for a Project prior to the execution by Sponsor of a Project Addendum or other mutually agreed upon writing, Sponsor agrees that PPD shall be compensated on a time and materials basis for Services performed at Sponsor’s request in accordance with the PPD Proposal for Services.

2.4 Taxes . All fees stated in this Agreement or any Project Addendum are net of Value Added Tax (“VAT”) or similar taxes. If any VAT or similar taxes are due, these will be payable by Sponsor in addition to the fees paid to PPD.

2.5 Payments . Unless otherwise set forth in a Project Addendum, all payments to PPD under this Agreement or any Project Addendum shall be made as follows:

Any changes to the payee information set forth above require a writing signed by PPD’s Treasurer or Chief Financial Officer.

3.1 Term . The term of this Agreement shall commence on the Effective Date and shall continue for a period of five (5) years unless extended by mutual written agreement by the parties; provided however, the term shall be extended as to any Project Addendum ongoing on the fifth anniversary of the Effective Date until the Services contemplated by the Project Addendum have been completed. Each Project Addendum shall be effective upon the date set forth in such Project Addendum and shall terminate upon (i) the completion of the Services to be provided thereunder, and (ii) PPD’s receipt of all Direct Fees, Pass Through Costs, and any other payments due to PPD related to the Services provided thereunder, unless earlier terminated in accordance with this Section 3.

3.2 Early Termination. This Agreement or any Project Addendum may be terminated by Sponsor with or without cause upon thirty (30) days prior written notice to PPD. PPD may terminate any Project Addendum upon Sponsor’s breach of Agreement upon thirty (30) days prior written notice, provided that such breach is not cured within such thirty (30) day period.

3.3 Insolvency . Either party hereto may terminate this Agreement immediately upon the occurrence of an “Insolvency Event” with respect to the other party. For purposes of this Agreement, “Insolvency Event” shall mean (1) a party or any of its subsidiaries shall commence a voluntary proceeding seeking liquidation, reorganization or other relief with respect to itself or its debts under any bankruptcy, insolvency or other similar law or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, or shall consent to any such relief or to the appointment of or taking possession by any such official in an involuntary case or other proceeding commenced against it, or shall make a general assignment for the benefit of creditors, or shall fail generally to pay its debts as they become due, or shall take any action to authorize any of the foregoing; (2) an involuntary case or other proceeding shall be commenced against a party or any of its subsidiaries seeking

liquidation, reorganization or other relief with respect to it or its debts under bankruptcy, insolvency or other similar law or seeking the appointment of a trustee, receiver, liquidator, custodian or other similar official of it or any substantial part of its property, and such involuntary case or other proceeding shall remain un-dismissed and un-stayed for a period of sixty (60) days; or (3) an order for relief shall be entered against a party or any of its subsidiaries under the federal bankruptcy laws now or hereafter in effect.

3.4 Effect of Termination . The termination of this Agreement by either party shall not automatically terminate all Project Addenda, unless otherwise agreed in writing. In the event of termination or expiration of this Agreement, the terms and conditions of this Agreement shall continue to apply to all Project Addenda still in effect after such termination or expiration.

3.5 Wind Down . Upon the termination of this Agreement or a Project Addendum, PPD shall reasonably cooperate with Sponsor to provide for an orderly wind-down of the Services provided by PPD hereunder, including assisting Sponsor in assigning agreements (if applicable) related to the Project (e.g., with Sites) and transferring duties for Services to Sponsor or its designee. Costs associated with such wind-down activities shall be billed to Sponsor on a time and materials basis, based on the rates in the Project Addendum for the Services and if not identified in the Project Addendum, the then-current PPD rates.

3.6 Provisions Surviving Termination . The expiration, termination or cancellation of this Agreement will not extinguish the rights of either party that accrue prior to expiration, termination or cancellation or any obligations that extend beyond expiration, termination or cancellation, either by their inherent nature or by their express terms, including, without limitation, the obligations contained in Sections 2 (Compensation and Payment), 3.4 (Effect of Termination), 3.5 (Wind Down), 3.6 (Provisions Surviving Termination), 6 (Confidentiality), 7 (Data Privacy), 8 (Intellectual Property), 9 (Indemnification), 10 (Limitation of Liability), 11 (Insurance) 12.2 (Record Maintenance after Expiration or Termination), 14.2 (Publicity), 14.5 (Notices), 14.6 (Governing Law), 14.7 (Severability), 14.10 (Assignment), 14.11 (Subcontracting), 14.12 (Arbitration) and 14.13 (Construction) hereof and herein shall survive termination of this Agreement.

4.1 Direct Fees . All Direct Fees owed to PPD for Services performed under this Agreement or any Project Addendum shall be invoiced to and paid by Sponsor in the “Contract Currency”, which shall be defined as the currency, or currencies, designated in any budget or payment schedule set forth in a Project Addendum. The parties agree that where possible, PPD will provide its budget for each Project Addendum in US Dollars (“USD”) globally with the exception of Services performed in Europe, Middle East and Africa (the “EMEA Region”), which will be in Euros.

In the event Sponsor desires to be invoiced in any currency other than Euros for Services performed in the EMEA Region, and other than USD for Services performed in all other regions, the parties shall specify in the Project Addendum the exchange rate or rates (“Contracted Exchange Rate”) to be used for the Project Addendum. The Contracted Exchange Rate will be used for the preparation of each invoice for Services and payment by Sponsor. The “Spot Rate” for purposes of reconciliation, shall mean the actual spot rate in the Wall Street Journal for the date on which the invoice is raised. At the conclusion of each calendar year, a reconciliation shall be undertaken by PPD. PPD shall compare the total value of the invoices billed to Sponsor at the Contracted Exchange Rate to the value of the same invoices when converted using the Spot Rates. In the event the comparison demonstrates that the total difference in such amounts is five percent (5%) or more of the annual invoice value or is greater than USD $50,000 (or the contracted currency equivalent when measured against the current spot rate), such difference shall be invoiced or credited, as the case may be, to Sponsor. The reconciliation invoice or credit note will be issued by PPD in Contract Currency. The process of reconciliation is not cumulative, but shall be conducted on a calendar year basis and completed by the end of March in the subsequent year.

4.2 Pass Through Costs . Where PPD incurs Pass Through Costs in a currency other than the Contract Currency, PPD shall, for Sponsor invoicing and payment purposes, convert such costs to the Contract Currency based on an average exchange rate between the local currency and the Contract Currency for the month in which such costs were incurred. This average exchange rate will be based on the monthly average of the daily exchange rates as published in the Wall Street Journal.

4.3 Investigator Fees . At the beginning of each study Sponsor shall advance PPD a pre-agreed value for the sole purpose of paying Investigator Fees. All future amounts invoiced to Sponsor will be based upon an accrual of costs owed to investigators, with the pre-agreed advance serving to provide available funds for PPD to make payments to investigator sites, while said invoices are processed by Sponsor. PPD shall pay investigator fees in the currency specified in the investigator agreements. For Sponsor invoicing and payment purposes, PPD shall convert all investigator fees that are to be paid in a currency other than the Contract Currency to the Contract Currency based on the average exchange rate between the currencies for the month prior to the month the invoice is raised. As each Project Addendum comes to a close, the original advance will be used to pay the final Investigator Fees with a reconciliation provided by PPD at the conclusion of the study reflecting how the funds were applied. This reconciliation will also compare the estimated exchange rate used for the purposes of invoicing on the basis of accrued costs versus the exchange rate when the actual payment was made to the investigator sites, and any variation will be invoiced or credited to Sponsor as applicable.

5.1 Project Management . The Services with respect to each Project shall be performed by PPD under the direction of the person identified as the operational lead in the applicable Project Addendum or such other person acceptable to Sponsor as PPD may from time to time designate as the Project Manager, such Sponsor acceptance of the designated Project Manager not to be unreasonably withheld or delayed in all instances.

5.2 Covenant Not to Interfere . During the term of a Project Addendum, neither party will solicit for employment any employee of the other party who is providing services under that Project Addendum. As used in this section “solicit” means the initiation by a party or its agent of a contact with any of the other party’s then current employees who are performing services under this Agreement for the purpose of offering employment to such employees, but shall not include the circumstance where any such employee initiates a contact with the other party for the purpose of obtaining employment whether in response to a general advertisement of employment or where such contact is initiated by a third party who was not instructed to contact such employee by the hiring party.

5.3 Personnel Retention . In the event of delays in the performance of the Project which are caused solely and directly by Sponsor, i.e., after PPD is authorized to commence work or delays beyond the reasonable control of PPD and where Sponsor desires for PPD to keep PPD Project personnel assigned to the Project, after PPD notifies Sponsor in writing (email to suffice) that additional fees will apply, Sponsor agrees that Sponsor shall pay a personnel fee calculated on an FTE-day basis. Said personnel fees shall be invoiced by PPD on a monthly basis, and shall be due and payable by Sponsor within 30 days of receipt of invoice.

6.1 Sponsor Confidential Information . PPD shall treat all information obtained from Sponsor and all Sponsor Property (as defined below) and any revisions improvements or enhancements thereto ( “Sponsor Confidential Information” ) as the confidential and exclusive property of Sponsor.

6.2 PPD Confidential Information . Sponsor shall treat all information obtained from PPD or any of PPD’s Affiliates including, without limitation, any PPD bids or proposals, standard operating procedures, third party confidential information, personnel information, all PPD Property (as defined below) and any revisions, improvements or enhancements thereto ( “PPD Confidential Information” ) as the confidential and exclusive property of PPD. In addition, any affiliate of Sponsor receiving information pursuant to this Agreement or any Project Addendum hereunder from PPD or any PPD Affiliate shall be bound by these confidentiality obligations. Further, any information disclosed, obtained, or observed by Sponsor or any affiliate of Sponsor during an audit of PPD or an Affiliate of PPD, or the facilities of either, with the exception of Sponsor Confidential Information, shall be treated as confidential by Sponsor in accordance with the terms contained herein. For the purposes of this Agreement, Sponsor Confidential Information and PPD Confidential Information shall collectively be referred to as “ Confidential Information .”

6.3 Use of Sponsor Confidential Information and PPD Confidential Information . Each party shall use the other’s Confidential Information solely for the purposes contemplated by this Agreement and for no other purpose without the prior written consent of the other party. Neither party shall publish, disseminate or otherwise disclose Confidential Information of the other to any third party without first obtaining the written consent of such other party. Each party shall restrict the dissemination of the other’s Confidential Information with its organization to only those persons who have a need to know, and shall ensure that all of its directors, officers, employees, agents, representatives and advisors (collectively, “Associates” ) are aware of this Agreement and bound by terms of confidentiality no less stringent than those stated herein. In addition, prior to providing any Confidential Information to a permitted third party other than an Associate, the receiving party will ensure that such third parties are bound to written obligations of confidentiality that are not less stringent than those contained herein.

6.4 Exceptions to Confidential Information . The above provisions of confidentiality shall not apply to that part of disclosing party’s Confidential Information which the receiving party is able to demonstrate by documentary evidence: (i) was in the receiving party’s possession prior to receipt from the disclosing party or is independently developed by or for the receiving party; (ii) was in the public domain at the time of receipt from disclosing party; (iii) subsequently becomes a part of the public domain through no fault of the receiving party or its Associates; or (iv) is lawfully received by the receiving party from a third party having a right of further disclosure.

6.5 Disclosure Required by Law . The non-disclosure obligations pursuant to this Agreement shall not apply to Confidential Information that a receiving party is required to disclose pursuant to any judicial action, order of the court or other governmental agency or requirement of the Securities and Exchange Commission or applicable securities exchange; provided, however, that the receiving party shall make all reasonable efforts to notify the disclosing party prior to the disclosure of Confidential Information and allow the disclosing party the opportunity to contest and avoid such disclosure, and further provided that the receiving party shall disclose only that portion of such Confidential Information that it is legally required to disclose. Notwithstanding the foregoing, Sponsor may disclose the existence and terms of this Agreement and any Project Addendum as needed to comply with any requirement of the Securities and Exchange Commission or applicable securities exchange, but subject to redactions as permitted by applicable rules without consent from PPD. However, Sponsor will provide reasonable notice to PPD that such disclosure is occurring.

6.6 Return of Information . Upon termination or expiration of this Agreement or at the disclosing party’s earlier written request, the receiving party shall return, and shall cause its Associates to return, all documentary, electronic or other tangible forms of Confidential Information provided by the disclosing party including, without limitation, any and all copies

thereof, or, at the disclosing party’s request, destroy all or such parts of the disclosing party’s Confidential Information as the disclosing party shall direct. Notwithstanding the foregoing, the receiving party may retain copies of such of the disclosing party’s Confidential Information as is reasonably necessary for regulatory and business archival purposes, subject to the ongoing obligation to maintain the confidentiality of such information.

6.7 Remedy . Each party agrees that its obligations hereunder are necessary and reasonable in order to protect the other party and the other party’s business, and expressly agrees that monetary damages would be inadequate to compensate the other party for any breach of the terms of this Agreement. Accordingly, each party agrees and acknowledges that any such violation or threatened violation will cause irreparable injury to the other party, and that, in addition to any other remedies that may be available, in law, in equity or otherwise, the other party shall be entitled to obtain injunctive relief against the threatened breach of this Agreement or a Project Addendum or the continuation of any such breach, without the necessity of proving actual damages.

6.8 Survival . The obligations contained herein shall survive for a period of ten (10) years from the date of the disclosure of the Confidential Information.

7.1 Definitions . For the purpose of this Section 7, ‘Personal Data’, ‘Process/Processing’, ‘Data Controller’, ‘Data Processor’ and ‘Data Subject’ shall have the same meaning as in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (“Directive 95/46/EC”) as implemented in the law of any EU Member State which is applicable to the provision of the Services or as defined in the law of any other country which is applicable to the provision of the Services (including, as applicable, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules, 45 C.F.R. Parts 160-164, and the Health Information Technology for Economic and Clinical Health Act (HITECH), P.L. No. 111-005, Part I, Title XIII, Subpart D, 13401-13409, and state privacy laws) (collectively referred to as the “Applicable Data Privacy Laws”).

7.2 Compliance . Each party warrants to the other that it will Process the Personal Data in compliance with all Applicable Data Privacy Laws.

7.3 Data Processing . Sponsor and PPD acknowledge that Sponsor is the Data Controller and PPD is the Data Processor with respect to the Processing of Personal Data relating to the Services provided under this Agreement. In the event that the Services are performed by any PPD Affiliate then such PPD Affiliate shall be a sub-Processor. PPD shall Process the Personal Data only in accordance with instructions from Sponsor or as may be required or permitted by law. (The instructions may be specific instructions or instructions of a general nature as set out in this Agreement, a Project Addendum, Protocol, SOP or SMMP or as otherwise notified by Sponsor to PPD during the Term).

7.4 Representative . If Sponsor needs to appoint a representative to comply with Applicable Data Privacy Law in any EU Member State pursuant to Article 4 of Directive 95/46/EC and PPD is willing to provide such services to Sponsor, Sponsor and PPD shall enter into a mutually acceptable agreement for such representative purposes. Unless and until such an agreement is entered into, PPD shall not be deemed to be a representative under any Applicable Data Privacy Law.

7.5 Security . PPD shall implement appropriate technical and organisational measures to protect the Personal Data as required by ICH-GCP and Applicable Data Privacy Laws.

7.6 Data Privacy Requests . PPD shall promptly notify Sponsor in writing if it receives any communication with regard to data privacy relating to the Services from a Data Subject, a privacy authority or other regulatory authority, and provide Sponsor with cooperation and assistance in relation to any such communication. PPD shall be entitled to charge Sponsor for such assistance, at its usual hourly rate, unless the communication relates to a breach or violation by PPD or a PPD Affiliate of its obligations under this Section 7. However, PPD and Sponsor recognize that any fees charged to the requesting party must comply with Applicable Data Privacy Laws.

7.7 Security Breaches . If PPD becomes aware of any breach of an Applicable Data Privacy Law relating to the Services, then it shall promptly notify Sponsor and, if requested, assist Sponsor in meeting any obligations under Applicable Data Privacy Law to notify Data Subjects, regulatory authorities or other required parties. PPD shall be entitled to charge Sponsor for such assistance, at its usual hourly rate, unless PPD or a PPD Affiliate was solely responsible for such breach.

7.8 Data transfers . PPD shall only Process or otherwise transfer Personal Data outside the European Economic Area (“EEA”) (member states of the European Union plus, Norway, Iceland & Liechtenstein) as necessary to provide services under this Agreement, or any Project Addendum, Protocol, SOP or SMMP, or where otherwise instructed by Sponsor. Where Personal Data are transferred to PPD’s US based Affiliates, they shall be protected by PPD’s membership of the US Department of Commerce Safe Harbor scheme. In providing services, it may be necessary to sub-contract certain tasks to one or more third party vendors, including cloud based service providers, whose servers may be located outside the EEA. Transfers of Personal Data to said vendors shall be proceed on the basis of Data Subject consent and/or through a commitment by the vendor to comply with the Principles of the Safe Harbor scheme. Sponsor as Data Controller shall in any event take necessary measures to ensure data transfers are lawful.

8.1 No License . Neither anything contained herein, nor the delivery of any information to a party hereto, shall be deemed to grant the receiving party any right or license under any patent or patent application or to any know-how, technology or invention of the disclosing party.

8.2 Sponsor Property .

a. All budgets, proposals, Protocols and other materials, documents, information and programs of every kind and description supplied to PPD or investigators by on or on behalf of Sponsor, and all materials, documents and information prepared or developed by PPD or investigators in the course of performing the work provided for in this Agreement including the inventions, technology, know-how and other intellectual property assigned under Section 8.2(b) (collectively “Sponsor Property”) and all revisions, improvements or enhancements thereto shall be the sole and exclusive property of Sponsor and PPD shall have no rights, title or interest in such Sponsor Property. PPD waives an renounces any rights to file or assert a lien on any Sponsor Property, including without limitation, any lien that may arise on account of non-payment.

b. Subject to Section 8.3 below, PPD hereby assigns to Sponsor all rights PPD or its Associates may have in any invention, technology, know-how or other intellectual property relating to a Project drug, Protocol or Sponsor Confidential Information or which is (i) a direct result of PPD’s provision of the Services or (ii) specifically set forth as a deliverable under a Project Addendum, and PPD shall assist Sponsor, at Sponsor’s sole cost and expense, in obtaining or extending protection therefor. PPD warrants that it has and will continue to have agreements with its Associates to effect the terms of this Section 8.2.

8.3 PPD Property . PPD possesses certain inventions, processes, technology, know-how, trade secrets, improvements, other intellectual property and assets, including, without limitation, those related to business or product plans or proposals, marketing strategies, standard operating procedures, data, composition of matter, research, experimental results, personnel data, financial information and conditions, pricing information, customer information, supplier/vendor information, raw materials, data collection and data management processes, laboratory analyses, analytical, biotechnology and clinical methods, procedures and techniques, computer technical expertise and software (including code) which have been independently developed without the benefit of the Sponsor Property (collectively, “PPD Property” ). Sponsor and PPD agree that any PPD Property or revisions, improvements or enhancements thereto shall be the sole and exclusive property of PPD, and Sponsor shall have no rights, title and interest to such PPD Property.

9.1 Sponsor Indemnity . Sponsor shall indemnify, defend, and hold harmless PPD, PPD Affiliates (as that term is defined in Section 14.10), and their Associates ( “ PPD Indemnitees ” ) from and against any and all damages, liabilities, losses, fines, penalties, settlement amounts, costs and expenses of any kind or nature whatsoever, including, without limitation, reasonable attorneys’ fees, expert witness fees, court costs, and amounts incurred by PPD Indemnitees in connection with any third party claim, demand, action, proceeding, investigation or hearing resulting from (i) any personal injury or death caused by the use of Sponsor’s study drug, or other materials supplied by Sponsor, or anyone acting on the Sponsor’s behalf, in connection with a Project Addendum, or any deviations from the applicable Protocol necessary to preserve the health, safety and welfare of the study subjects; (ii) any claims for patent infringement related to a study drug, compound or other materials supplied by Sponsor, or anyone acting on Sponsor’s behalf, to PPD in connection with a Project Addendum; (iii) the negligent acts, omissions or willful misconduct of any subcontractor selected by Sponsor; or (iv) the negligence or willful misconduct of a Sponsor Indemnitee or a material breach of this Agreement by Sponsor; provided however, that Sponsor shall have no obligation of indemnity hereunder with respect to any claim to the extent such claim arises from the negligence, intentional misconduct or material breach of the Agreement or any Project Addenda on the part of PPD or its Associates or any PPD Indemnitee.

9.2 PPD Indemnity . PPD shall indemnify, defend and hold harmless Sponsor and its Associates (“Sponsor Indemnitees”) from and against any and all damages, liabilities, losses, fines, penalties, settlement amounts, cost and expenses of any kind or nature whatsoever, including, without limitation, reasonable attorney’s fees, expert witnesses and court costs, arising out of the negligence, willful misconduct, or breach of this Agreement or any Project Addenda by PPD or its Associates; provided however, that PPD shall have no obligation of indemnity hereunder with respect to any claim to the extent such claim arises from the negligence or intentional misconduct or material breach Agreement or any Project Addenda on the part of Sponsor or its Associates.

9.3 Indemnification Procedure . Each indemnified party shall give the indemnifying party prompt notice of any claim for which indemnification is sought hereunder; provided however that the failure to provide prompt notice shall not release the indemnifying party of its obligations hereunder except to the extent it is irrevocably prejudiced in defending or settling the claim. The indemnifying party shall have the right to control the defense and settlement of a claim, at its sole expense, provided the indemnifying party shall act reasonably and in good faith with respect to all matters relating to the settlement or disposition of the claim, and the indemnified party shall reasonably cooperate in the investigation, defense and settlement of such claim at the indemnifying party’s expense. Neither party will enter into any settlement agreement that attributes fault or negligence to the other party, requires any payment by the other party, or restricts the future actions or activities of the other party, without the other party’s prior written consent, which shall not be unreasonably withheld. Any indemnified party shall have the right to

participate in, but not control, the defense and settlement of a claim and to employ separate legal counsel of its own choice; provided, however, that such employment shall be at the indemnified party’s own expense, unless (i) the employment thereof has been specifically authorized by the indemnifying party, or (ii) the indemnifying party has failed to assume the defense and employ counsel (in which case the indemnified party shall control the defense and settlement of such claim). The costs and expenses, including reasonable fees and disbursements of counsel, incurred by any indemnified party in connection with any claim shall be reimbursed on a monthly basis by the indemnifying party subject to refund in the event the indemnifying party is ultimately held not to be obligated to indemnify the indemnified party.

NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT (OR THE TERMINATION HEREOF) OR ANY PROJECT ADDENDUM, INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS OR ANTICIPATED SALES, EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

11.1 Sponsor and PPD will each undertake to purchase and maintain insurance of such types and amounts reasonably adequate to cover any liabilities arising out of its obligations hereunder. Sponsor further undertakes to purchase and maintain insurance of such types and amounts and coverage reasonably adequate (including but not limited to that required by law) to cover any liabilities arising in relation to all clinical trials contracted to PPD pursuant to this Agreement. The following sets forth the minimum thresholds of insurance each party will maintain:

11.2 PPD Insurance . PPD shall, at its own cost and expense, obtain and thereafter maintain in full force and effect and with properly licensed and financially secure insurers (AM Best rating of A-VII in the United States and reasonably equivalent in countries outside the United States) the following insurance during the term of this Agreement and for a period of not less than three (3) years following termination of this Agreement: