CONFIDENTIAL PORTIONS HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”).** TASK ORDER MEDPACE Task Order Number: 1 MEDPACE Project Number:...
Exhibit 10.22
**CONFIDENTIAL PORTIONS HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION (THE “COMMISSION”).**
MEDPACE Task Order Number: 1
MEDPACE Project Number: ORINS07
This Task Order, dated 27 September 2012, is between Medpace, Inc. (“MEDPACE”), and Oramed Ltd., (“SPONSOR”).
RECITALS:
WHEREAS, MEDPACE and SPONSOR have entered into that certain Master Services Agreement dated 27 September 2012 (the “Master Services Agreement”); and
WHEREAS, pursuant to the Master Services Agreement, MEDPACE has agreed to perform certain Services in accordance with Task Orders from time to time entered into by the Parties and SPONSOR and MEDPACE now desire to enter into such a Task Order; and
WHEREAS, MEDPACE and SPONSOR desire that MEDPACE provide certain services with respect to a protocol entitled, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Multiple Oral Bedtime Doses of ORMD-0801 (Insulin Capsules) in Adult Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled with Diet and Metformin (the “Study”) for the study of the product ORMD-0801 (“Study Product”) as set out in the Protocol Number: ORA-D-007, which is incorporated herein by reference;
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the Parties hereby agree as follows:
|
|
1.
|
Scope of Work: MEDPACE shall perform the services described in the Scope of Work, attached hereto as Appendix 1, in accordance with the Project Schedule, attached hereto as Appendix 2, and protocol version dated 14 August 2012.
|
|
|
2.
|
Compensation: For performance of these Services, SPONSOR shall pay to MEDPACE an amount equal to the Project Budget set forth in Appendix 3, which amount shall be payable pursuant to the Payment Schedule set forth in Appendix 4. The Project Budget is provided for cost analysis purposes. It is agreed that all fees are fixed prices unless the underlying assumptions as written in Xxxxxxxx # 0 SCOPE OF WORK, and Appendix #2, PROJECT SCHEDULE are changed, and all such changes shall be documented in a Contract Amendment. After staff is assigned, costs are incurred based upon allocation of staff capacity.
|
|
|
3.
|
Third Parties/Vendors: MEDPACE is responsible for coordinating with the vendors which will be selected and approved by SPONSOR. SPONSOR will review and comment on all Third Parties/Vendors contracts prior to MEDPACE’s execution of such contracts.
|
|
|
4.
|
Transfer of Obligations: Sponsor Obligations transferred to MEDPACE by SPONSOR (consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D) are identified in Appendix 5.
|
|
|
5.
|
MSA. The provisions of the Master Services Agreement are hereby expressly incorporated by reference into and made a part of this Task Order.
|
IN WITNESS WHEREOF, the Parties have hereunto signed this Task Order effective as of the day and year first written above.
MEDPACE, INC.
|
Signature:
|
/s/ Xxxx Xxxxx
|
|
By:
|
Xxxx Xxxxx
|
|
Title:
|
Executive Director
Business Development Support
|
Oramed Ltd.
|
Signature:
|
/s/ Xxxxx Xxxxxx
|
|
By:
|
Xxxxx Xxxxxx
|
|
Title:
|
CEO
|
List of Appendices:
Appendix 1: Scope of Work
Appendix 2: Project Schedule
Appendix 3: Project Budget
Appendix 4: Payment Schedule
Appendix 5: Transfer of Obligations
Page 2 of 15
APPENDIX 1: SCOPE OF WORK
Project Specifications
|
Item
|
Description
|
|
Number of investigators per country
|
10 sites + 0 Xxxx-xx xxxxx (Xxxxxx Xxxxxx)
|
|
Number of screened patients
|
294 patients
|
|
Number of randomized patients
|
147 patients
|
|
Duration of enrollment period (first patient in–last patient in)
|
4 months
|
|
Duration of screening/treatment/follow-up period
|
~7.5 weeks
|
|
Duration of Investigator Meeting
|
1 meeting (12-hour duration); location TBD
|
|
Location and duration of Kickoff Meeting
|
1 meeting at Medpace (8-hour duration)
|
|
Teleconferences
|
26 calls ( approx. 2 per month; one hour each)
|
|
Number of qualification visits
|
1 visit
|
|
Number of initiation visits
|
10 visits
|
|
Number of routine monitoring visits (RMV)
|
40 visits
|
|
Monitoring frequency
|
On average, every 5-6 weeks as needed
|
|
Number of close-out visits
|
Assumed part of final RMV
|
|
Number of serious adverse events (SAEs)
|
8 SAEs
|
|
Total CRFs
|
5880 CRFs
|
|
CRFs per patient
|
40 CRFs
|
|
Unique CRFs
|
18 CRFs
|
|
Average data points per CRF
|
12 data points
|
|
Number of raw listings
|
23 raw listings
|
|
Number of unique TFLs
|
25 unique TFLs
|
|
Number of version TFLs
|
25 version TFLs
|
|
Study conducted in compliance with SOPs and Policies
|
Medpace SOPs and Policies
|
Page 3 of 15
Roles and Responsibilities
|
1.1
|
PROJECT START-UP
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Write protocol
|
|||
|
X
|
Review protocol
|
Includes comment from Medpace team
|
||
|
X
|
Submit protocol amendments
|
|||
|
X
|
Develop ICF template
|
Using Medpace template
|
||
|
X
|
Review ICF template
|
|||
|
X
|
ICF amendments
|
1 amendment
|
||
|
X
|
ICF local customization
|
Negotiate changes with each site
|
||
|
X
|
CRF design
|
Design of CRFs and completion guidelines
|
||
|
X
|
X
|
Site identification
|
Medpace to identify qualified Investigators; Oramed to select/approve sites; assumes 15 sites selected (10 main sites + 5 back-up sites)
|
|
|
X
|
Investigator Meeting Planning
|
Arrange meeting
|
||
|
X
|
Preparation of Investigator Meeting(s)
|
Preparation and distribution of binders and meeting materials; includes presentation by Medpace associates
|
||
|
X
|
Investigator Meeting Attendees
|
CTM, Medical Expert, Project Coordinator, Data Manager, Statistical Analyst, Safety Manager, IVRS Manager and 3 CRAs; Assumes 1 day meeting
|
||
|
X
|
X
|
Investigator Meeting Planner Contract Negotiation and Payment Management
|
Medpace will negotiate the contract on behalf of Sponsor; Sponsor will sign the contract and make payments to the meeting planner
|
|
|
X
|
Kickoff Meeting Attendees
|
CTM, Medical Expert, Project Coordinator, Project Assistant, Regulatory Submissions Manager, Data Manager, Statistical Analyst, Safety Manager, Safety Specialist and Lead CRA; Assumes 8 hrs. meeting at Medpace office
|
||
|
X
|
Submit essential documents to US central IRB
|
13 sites using central IRB (9 main + 4 back-up sites)
|
||
|
X
|
Support sites to submit essential documents to US local IRB
|
2 site using local IRB (1 main + 1 back-up sites)
|
||
|
X
|
Trial Master File set-up and maintenance
|
Set up and maintain file for all study sites according to Medpace SOPs
|
|
1.2
|
CLINICAL OPERATIONS
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Clinical trial management
|
Provide overall study management for 10 sites
|
||
|
X
|
Project website
|
Medpace to develop secure, project-specific website containing relevant information and tools
|
||
|
X
|
Newsletters
|
6 monthly electronic newsletters
|
||
|
X
|
Ongoing essential document collection
|
Ongoing collection and maintenance of site-specific documents
|
||
|
X
|
Tracking of study medication shipments
|
Assumes 2 shipments per site for 10 sites
|
||
|
X
|
Supply, packaging, and labeling of study medication
|
Assumes Medpace will contract and manage packaging, labeling and drug depot vendor
|
||
|
X
|
Storage and distribution of
Study medication
|
Assumes Medpace will contract and manage vendor to perform packaging, labeling and drug depot services
|
||
|
X
|
X
|
Destruction of study medication
|
Assumes Medpace will contract and manage drug depot vendor who will destroy drug upon Sponsor approval
|
|
|
X
|
Study medication accountability procedures
|
Follow Medpace SOPs and approved by Sponsor
|
||
|
X
|
Site contract negotiation
|
Negotiate site contract and budget for 15 sites
|
||
|
X
|
Investigator payments management
|
Make 2 quarterly payments per site for 10 sites
|
||
|
X
|
X
|
External vendors contract negotiation and management
|
Assumes Medpace will contract and manage drug depot vendor; Medpace will coordinate the purchase and distribution of CGM devices and study supplies upon sponsor approval
|
|
|
X
|
Central lab selection
|
Please reference MRL budget
|
||
|
X
|
Central lab contract negotiation and management
|
MRL
|
||
|
X
|
Central IRB payment management
|
Assumes 1 central IRB and 2 quarterly payments
|
Page 4 of 15
|
1.3
|
CLINICAL MONITORING
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Clinical Research Associates (CRAs)
|
3 CRAs
|
||
|
X
|
Qualification visits
|
1 visit, 4 hrs. on-site; Cost of $2,347 shall be charged for each additional visit
|
||
|
X
|
Monitoring plan
|
Ongoing updates
Includes monthly meetings
|
||
|
X
|
Site initiation visits
|
10 visits, 4 hrs. on-site; Cost of $2,347 shall be charged for each additional visit
|
||
|
X
|
Routine monitoring visits (RMVs)
|
40 visits
|
||
|
X
|
Frequency of RMVs
|
On average, every 5-6 weeks, as needed
|
||
|
X
|
Estimated on-site time
|
16 hours
|
||
|
X
|
Close-out visits
|
Assumed combined with final RMV
|
||
|
X
|
In-house monitoring coordination
|
Medpace CRA contact sites to discuss project-specific issues; records maintained in ClinTrak
|
Page 5 of 15
|
1.4
|
CLINICAL SAFETY
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Medical monitoring
|
Medical Expert on-call 24/7 during recruitment and treatment periods for 10 sites
|
||
|
X
|
Develop Safety Monitoring Plan
|
Includes one final version and one revision. Assumes utilization of Medpace SOPs
|
||
|
X
|
SAE reporting
|
All SAEs will be reported by sites to Medpace. Includes one initial and two follow-up reports per case; Assumes 8 SAEs; Cost of $1,339 shall be charged for each additional unit
|
||
|
X
|
Development of safety database
|
ARGUS will be used; Medpace to hold database
|
||
|
X
|
Enter SAEs into safety database
|
8 SAEs
|
||
|
X
|
Medical monitor review of SAE reports
|
Includes assessment of expectedness and company causality
|
||
|
X
|
Receive, query, and follow-up on reported SAEs
|
|||
|
X
|
Generate SAE narratives
|
Narratives written Clinical Study Report ready. Assumes final approval by Medpace Medical Monitor prior to distribution to sponsor.
|
||
|
X
|
Generate expedited SAE reports safety report
|
Assumes 1 expedited report, if additional events occur, a unit cost of $1,636 per report shall be charged.
|
||
|
X
|
X
|
Distribute expedited SAE reports to FDA
|
Oramed to review and approve prior to submission
|
|
|
X
|
Distribute expedited SAE reports to central IRB
|
Compile and submit documents
|
||
|
X
|
Preparation of safety notification letters
|
Sponsor to review and approve prior to submission
|
||
|
X
|
Distribute safety notification letter for this protocol to sites
|
10 sites
|
||
|
X
|
Prepare periodic reports for regulatory authorities
|
|||
|
X
|
X
|
Prepare Annual Safety Report
|
Medpace to prepare safety line listings to be included in IND Annual Report; Oramed will be responsible for IND Annual Report filing
|
|
|
X
|
Distribute periodic reports to regulatory authorities/ECs
|
|||
|
X
|
Distribute Annual Safety Report to regulatory authorities/ECs
|
Assumes Oramed will be responsible for IND Annual Report
|
||
|
X
|
Ongoing reconciliation between clinical and safety database
|
A final reconciliation is completed prior to database lock
|
||
|
X
|
Ongoing clinical trial AE data review including signal detection and trend analysis
|
Required per FDA guidance
|
||
|
X
|
Write narratives for withdrawals due to AE and/or abnormal lab values for inclusion in clinical study report
|
Assumes 1 withdrawal due to AE. If additional events occur, a unit cost of $915 shall be charged.
|
|
1.5
|
IVR/IWR SYSTEM
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Randomization/Drug Supply Management
|
Provide study-specific system for randomization, patient visit tracking, and customized reports, drug management (via web or phone 24/7), including maintenance and Help Desk. Assumes English language only.
|
Page 6 of 15
|
1.6
|
DATA MANAGEMENT
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Develop data management (DM) documents
|
DM documents include:
- Database specifications;
- Guidelines for the tracking of CRFs and data queries;
- Guidelines for entry of the CRF data; and
- Database edit check specifications
|
||
|
X
|
Database development
|
EDC system, ClinTrak EDC
|
||
|
X
|
Database validation
|
Medpace SOPs
|
||
|
X
|
EDC Help Desk
|
Medpace provide support via phone/email
|
||
|
X
|
DM coordination and status reporting
|
Medpace coordination includes:
- CRF tracking
- Data cleaning/editing
- Query tracking
Medpace monthly DM status reports provided via secure website include:
- CRF status by site
- Patient status by site
- Query status by site
|
||
|
X
|
Query tracking/resolution
|
|||
|
X
|
Coding of AE/concomitant medications/medical histories
|
Assumed that Sponsor holds a valid agreement with the Maintenance and Support Services Organization (MSSO) for the MedDRA dictionary and Uppsala Monitoring Centre (UMC) for the WHODrug dictionary
|
||
|
X
|
Number of AE codes
|
5 AE codes per patient
|
||
|
X
|
Number of concomitant medications
|
5 concomitant medications per patient
|
||
|
X
|
Number of medical histories/conditions
|
|||
|
X
|
Number of external data sources
|
Assumes MRL
|
||
|
X
|
Data transfers from external data sources
|
2 quarterly transfers from MRL
|
||
|
X
|
Data transfers to Sponsor
|
2 transfers (1 test, 1 final)
|
||
|
X
|
Deliver data
|
CDISC SDTM
|
||
|
X
|
Database document
|
Medpace submission-ready
|
|
1.7
|
STATISTICAL ANALYSIS
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Develop Statistical Analysis Plan (SAP)
|
Medpace format and template; Medpace to prepare the SAP to be included in the IND filing. The SAP will be revised (if needed) and finalized prior to the Database Lock.
|
||
|
X
|
Programming, validation, and generation of Tables, Figures, Listings (TFLs)
|
23 raw listings
25 unique TFLs
25 version TFLs
2 derived datasets
|
||
|
X
|
Results review meeting
|
One meeting via teleconference after delivery of analysis results
|
Page 7 of 15
|
1.8
|
MEDICAL WRITING
|
|
Oramed
|
Medpace
|
N/A
|
Item
|
Description
|
|
X
|
Study report shell (SRS)
|
SRS incorporates protocol-related and statistical methodology information and in-text table shells in the results sections
|
||
|
X
|
SRS review
|
|||
|
X
|
Pre-final study report (PFSR)
|
PFSR is a complete version of the report, including results, but without the appendices
|
||
|
X
|
PFSR review
|
|||
|
X
|
Final study report (FSR)
|
FSR is a complete version of the report including appendices.
|
||
|
X
|
Publishing FSR
|
FSR file is converted to an Adobe PDF file and published by setting applicable document attributes.
|
||
|
X
|
Bookmarking/
hyperlinking FSR
|
Apply internal and external navigation via bookmarking/hyper linking from the FSR to any corresponding appendices
|
Page 8 of 15
APPENDIX 2: PROJECT SCHEDULE
|
Task
|
Date
|
|
Medpace Begins Work*
|
SEP-2012
|
|
Final Protocol
|
SEP-2012
|
|
Statistical Analysis Plan (Final Draft for IND Filing)**
|
15-NOV-2012
|
|
First Patient, First Visit
|
31-JAN-2013
|
|
Last Patient, First Visit
|
02-JUN-2013
|
|
Last Patient, Last Visit
|
25-JUL-2013
|
|
Final Database Lock
|
+ 6 weeks
|
|
Final Tables, Figures, and Listings available
|
+4 weeks
|
|
Delivery of Final Clinical Study Report
|
+ 8 weeks
|
|
Medpace Ends Work
|
NOV-2013
|
* Assumes Medpace receives final protocol and Investigator Brochure (IB) at start date.
** SAP date (Nov. 15, 2012) will depend on the Task Order signing and Final Protocol date. Medpace requires 6 weeks from these dates (whichever is later) to provide the SAP.
Page 9 of 15
APPENDIX 3: PROJECT BUDGET
|
Medpace Fees
|
Fee Details
|
|||
|
Unit Desc
|
# Unit
|
Unit Cost
|
Fee
|
|
|
Start-up Services Review Protocol
|
Protocol
|
1
|
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**
|
|
|
CRF Review/Development
|
CRF Book
|
1
|
||
|
Investigator Meeting
|
Meeting
|
1
|
||
|
Kick-Off Meeting
|
Meeting
|
1
|
||
|
Project Specific Training
|
Study
|
1
|
||
|
Vendor Contract Negotiation
|
Vendor
|
1
|
||
|
Investigator Contract Negotiation
|
Site
|
1
|
||
|
Site Identification/Selection
|
Site
|
15
|
||
|
Investigator File Set-up
|
Study
|
1
|
||
|
Initial Essential Document Collection
Total
|
Site
|
15
|
||
|
Meetings Conference Calls
Total
|
Call
|
26
|
||
|
Interactive Voice Response IVRS Development
System (IVRS)
|
System
|
1
|
||
|
IVRS Maintenance and Help Desk
|
Months
|
5.8
|
||
|
IVRS System Utilization and Hosting
Total
|
Months
|
5.8
|
||
|
Project Management Project Management
|
Months
|
5.8
|
||
|
Vendor Management
|
Months
|
5.8
|
||
|
Newsletters
|
Edition
|
6
|
||
|
Ongoing Essential Document Collection and Review
|
Months
|
5.8
|
||
|
ICF Amendment
|
Amendments
|
1
|
||
|
Vendor Payment Administration
|
Payment
|
6
|
||
|
Investigator Grants Management Total
|
Site Payments
|
20
|
||
|
Clinical Safety Medical Monitoring
|
Months
|
5.8
|
||
|
Safety Plan Development
|
Plan
|
1
|
||
|
SAE Reporting
|
Events
|
8
|
||
|
Processing Expedited SAE Reports
|
Events
|
1
|
||
|
Other Narrative Preparation Total
|
Events
|
1
|
||
|
Clinical Monitoring Monitoring Plan Development
and Ongoing Maintenance
|
Months
|
5.8
|
||
|
Pre-Study Visits
|
Visits
|
1
|
||
|
Study Initiation Visits
|
Visits
|
10
|
||
|
Site Management
|
Site Month
|
58.1
|
||
|
Routine Monitoring Visits Total
|
Visits
|
40
|
||
Page 10 of 15
|
Medpace Fees
|
Fee Details
|
|||
|
Xxxx Xxxx
|
# Xxxx
|
Xxxx Xxxx
|
Fee
|
|
|
Data Management Data Management Manual
|
Study
|
1
|
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**
|
|
|
Database Development
|
Database
|
1
|
||
|
Database Conversion (CDISC)
|
Database
|
1
|
||
|
EDC User Acceptance Testing
|
UAT
|
1
|
||
|
Data Entry and Cleaning
|
CRF Book
|
5880
|
||
|
EDC Help Desk
|
Site Months
|
58.1
|
||
|
DM Coordination and Status Reports
|
Months
|
5.8
|
||
|
EDC System Utilization and Hosting
Total
|
Months
|
5.8
|
||
|
Biostatistics Analysis Plan
|
Ran
|
1
|
||
|
Analysis Programming and Generation
|
Analysis
|
1
|
||
|
Raw Data Listings
|
Raw Listings
|
23
|
||
|
Unique TLFs
|
Unique TFL
|
25
|
||
|
Version TLFs Total
|
Version TFL
|
25
|
||
|
Medical Writing Clinical Study Report
Total
|
Study Report
|
1
|
||
|
Total Direct Fees
|
$1,267,246.18
|
|||
|
Fee Details
|
||||
|
Xxxx Xxxx
|
# Xxxx
|
Xxxx Xxxx
|
Fee
|
|
|
Pre-Funded Expenses Investigator Payments
|
Randomized Patients
|
147
|
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**
|
|
|
Drug Packaging, labeling and Depot Fees
|
Study
|
1
|
||
|
Central Laboratory Fees (MRL)
|
Study
|
1
|
||
|
Study Specific Supplies (CGM & Supplies)
|
Study
|
1
|
||
|
CGM Data Management Software (SweetSpot)
|
System
|
1
|
||
|
Total Pre-Funded Expenses:
|
$1,686,001.56
|
|||
|
Pass-Through Costs Monitoring Tray el
|
Visit
|
51
|
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**
|
|
|
Central IRB Fees
|
Study
|
1
|
||
|
Telecommunication Fees
|
Calls
|
26
|
||
|
Misc. Printing/Copying/Shipping
|
Sites
|
10
|
||
|
Meeting Expense
|
Study
|
1
|
||
|
Total Pass Through Costs:
|
$80,201.00
|
|||
|
Sponsor Directly Paid Vendor Investigator Meeting Planner
Fee
|
Meetings
|
1
|
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.**
|
|
|
Total Sponsor Directly Paid Vendor Fee
|
$83,450.00
|
|||
Page 11 of 15
APPENDIX 4: PAYMENT SCHEDULE
Payment Schedule
|
Payment Schedule
Project Ph II Study of ORMD-0801 in Patients w/ T2DM Total Direct Fees: $ 1,267,246
Sponsor: Oramed Pharmaceuticals, Ltd.
|
||||
|
Payment Number
|
Milestones
|
Approximate
Date
|
Amount to
Pay
|
Percentage
|
|
1
|
Task Order Signed
|
Sep-12
|
$ 63,362
|
5.0%
|
|
2
|
Kick-Off Meeting
|
11/5/2012
|
$ 139,397
|
11.0%
|
|
3
|
Investigator Meeting
|
1/3/2013
|
$ 76,035
|
6.0%
|
|
4
|
First Patient Screened
|
1/31/2013
|
$ 190,087
|
15.0%
|
|
5
|
25% Patients Enrolled
|
3/16/2013
|
$ 190,087
|
15.0%
|
|
6
|
50% Patients Enrolled
|
4/18/2013
|
$ 190,087
|
15.0%
|
|
7
|
Last Patient Screened
|
6/2/2013
|
$ 164,742
|
13.0%
|
|
8
|
Last Patient Complete
|
7/25/2013
|
$ 126,725
|
10.0%
|
|
9
|
Submission of Clinical Study Report to Sponsor for Final Approval
|
11/30/2013
|
$ 126,725
|
10.0%
|
|
Total Payments:
|
$ 1,267,246
|
100%
|
||
**THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.** of the total Pre-funded Expenses and $8,020 (10%) of total Pass-through Costs will be invoiced and due upon completion of the Kick-Off Meeting. Medpace will invoice Sponsor as needed for actual Pre-funded Expenses incurred. Sponsor shall pay such invoice within twenty (20 days) of receipt. If sufficient funds are not received from Sponsor, payments to Pre-funded Vendors may be delayed.
Medpace shall apply the initial **THE CONFIDENTIAL PORTION HAS BEEN SO OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION.** Pre-funded amount paid upon completion of the Kick-Off Meeting, against the last invoice of actual-Pre-funded Expenses, and reconcile the balance. Pass-through Costs will be billed to Sponsor on a monthly basis or as incurred.
Page 12 of 15
Payment Information and General Conditions
Pass-through Costs and Pre-funded Expenses
Any sums quoted with respect to pass-through costs and pre-funded expenses are provisional, pending discussion with third parties and are not necessarily exhaustive. While Medpace will endeavor to negotiate favorable rates for pass-through costs and pre-funded expenses, final costs may be dependent upon factors that are outside the control of Medpace. Payments made to third parties are not subject to xxxx-up charges.
Pass-through costs may include, but are not limited to, project-specific printing, shipping, copying and binding costs, telecommunication and data costs, travel costs, including subsistence and accommodation costs in compliance with the Medpace travel policy, literature search and article retrieval costs, translation costs, central IRB fees, EC/regulatory fees, and pharmacy fees. Costs associated with, project-specific printing, copying and binding are as detailed in the table below.
|
Item
|
Cost*
|
Description
|
|
b/w print, 20-24 lb.
|
0.15
|
total sheets, includes all impressions, sizes, or cuts
|
|
color print, 20-24 lb.
|
0.20
|
total sheets, includes all impressions, sizes, or cuts
|
|
b/w print, 28-60 lb.
|
0.20
|
total sheets, includes all impressions, sizes, or cuts
|
|
color print, 28-60 lb.
|
0.25
|
total sheets, includes all impressions, sizes, or cuts
|
|
b/w waterproof
|
1.05
|
total sheets, includes all impressions, sizes, or cuts
|
|
color waterproof
|
1.10
|
total sheets, includes all impressions, sizes, or cuts
|
|
tabs 5-bank
|
3.00
|
|
|
laminating pouches
|
0.95+
|
Plus cost of color or b/w print
|
|
card/cover stock
|
0.30
|
color only
|
|
folder
|
0.50
|
2-pocket, usually includes label
|
|
binder 1"
|
8.00
|
includes front cover and spine
|
|
binder 1.5"
|
10.00
|
includes front cover and spine
|
|
binder 3"
|
15.00
|
includes front cover and spine
|
|
plastic coil binding 1/4"
|
0.75
|
|
|
plastic coil binding 3/8"
|
1.10
|
|
|
plastic coil binding 1/2"
|
1.50
|
|
|
plastic coil binding 1"
|
3.00
|
|
|
CDs
|
0.28
|
per CD
|
|
CD labels
|
0.18
|
per label
|
*Currency is Euros for Europe, Israel, and South Africa; US dollars for remaining regions. Costs are subject to change based on fluctuations in supplier prices.
Page 13 of 15
Medpace will pass-through mobile communication and data charges up to $25 per travel day. This will include a standard daily rate and other internet charges (e.g. hotel, airline)
|
Item
|
Cost
|
Description
|
|
Mobile communication and data standard daily rate
|
$10/8€*
|
cost per day while CRA is traveling
|
|
Other internet charges by use (receipt required)
|
Up to $15
|
*Currency is Euros for Europe, Israel, and South Africa; US dollars for remaining regions
Pre-funded Expenses
Pre-funded expenses may include, but are not limited to, Investigator Meeting planner fees, Investigator fees, drug packaging and labeling, EDC vendor fees, and laboratory fees. Investigator fees are an estimate generated on Medpace’s initial feasibility and prior experience in this therapeutic area. The investigator fee amount is subject to changes of +/- 20% of the total amount after completion of a full feasibility and final site selection. The laboratory fee amount is subject to change after finalization of the laboratory services agreement.
Additional Costs
This is a fixed-price Task Order for direct fees, based upon the project specifications and assumptions detailed herein. The project budget and the unit costs upon which it was generated is provided for cost analysis purposes.
All direct fees are fixed costs unless the underlying assumptions change, including but not limited to, protocol, trial duration, number of investigative sites, number of patients, and services provided by Medpace. All such changes shall be documented in a contract amendment. After staff are assigned, costs are incurred based upon allocation of staff capacity.
Inflation
The fees stipulated in the fee estimate include inflation for the duration of the study as specified in this Task Order. Any significant shift in timelines will require a revision to the fees.
Currency
The currency of the Task Order is Unites States Dollars (USD).
Applicable Taxes
All direct fees, pass-through costs, and pre-funded expenses are quoted excluding any applicable taxes, which include but are not limited to Value Added Tax (VAT), Harmonized Sales Tax (HST), Goods and Services Tax (GST), which may be payable to Medpace by Sponsor.
Page 14 of 15
Appendix 5: Transfer of Obligations
CONFIDENTIAL
Directions: Complete a form for each clinical study where Sponsor obligations have been transferred in accordance with 21 CFR Part 312, Subpart D (Responsibilities of Sponsors). Forward the completed form to Sponsor’s Regulatory Affairs Department for submission to the applicable regulatory agencies.
Page 15 of 15
