Master Services Agreement Dated Between Kitov Pharmaceuticals Limited (Kitov)
Exhibit 10.3
Master Services Agreement Dated
Between Kitov Pharmaceuticals Limited (Kitov)
and
Java Clincial Research Ltd ( JAVA)
|
CHANGE ORDER FORM (1)
| |
|
PROTOCOL NUMBER:
|
K-302-03-01 |
|
Kitov CONTACT:
|
Mr Simcha Rock |
|
SUPPLIER CONTACT:
|
▇▇ ▇▇▇▇ ▇▇▇▇▇▇ |
|
DATE OF REQUEST:
|
26 03 2014 |
|
BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST:
The Original MSA dated 04 February refers only to Java Professional and Pass through Fees. This change order reflects total agree PI Fees for both Republic of Ireland and Northern Ireland.
| |
|
IMPACT (estimated effort and/or timeline):
This change order has no impact on effort or timelines. | |
|
COST: Total additional cost: €669,989.60
Payment Terms: Payment details and schedules are detailed in Appendix 1 & 2
| |
| Amendment: This Change Order Form shall constitute a Contract Amendment to the MSA dated 04 February 2014 between Kitov and Java and shall apply only to the revision of PIs fees attached hereto. In all other respects the terms and conditions of the MSA shall remain in full force and effect and shall be applied to this Contract Amendment. | |
|
Kitov Pharmaceuticals Ltd
/s/ Simcha Rock (Signature)
26/3/2014 (Date)
|
Java
/s/ ▇▇▇▇ ▇▇▇▇▇▇ (Signature)
26/03/2014 (Date) |
Change order no 1
Kitov/ Java MSA
Page 1 of 3
Appendix 1
PI Fees Republic of Ireland
Fees payable to Java Clinical Research Ltd
| Study Reference K-03-01 | ||||||
| Estimate ROI Investigator Costs (Euro) | ||||||
| Investigator fees | 72,000.00 | Cost per screen failure: €720 x 100 subjects | ||||
| 257,500.00 | Cost per randomised subject: €2575 x 100 subjects | |||||
| Total | 329,500.00 | |||||
| Other Investigator Pass through costs | ||||||
| GP Patient Referral Fee | 7,500.00 | Estimate: 100 patients x €100 per patient | ||||
| Community Screening Clinics | 7,500.00 | Estimate: €1000 per site x 10 sites | ||||
| ABPM subject lifestyle inconvenience reimbursement | 25,000.00 | Screen failures: 100 x 1 x €50; Randomised subjects: 100 x 4 x €50 | ||||
| Estimated receipted subject travel expenses | 60,000.00 | Screen failures:100 x 3 visits x €50; Randomised subjects:100 x 9 visitsx €50 | ||||
| Total | 100,000.00 | |||||
| Proposed payment of PI fees | Estimate Invoice Date | |||||
| Upfront payment of 25% | 82,375.00 | Apr-14 | ||||
| Payments every 2 months thereafter based on subject visits | ||||||
| 82,375.00 | Jul-04 | |||||
| 82,375.00 | Sep-14 | |||||
| 82,375.00 | Nov-14 | |||||
| 329,500.00 | ||||||
| Pass through Fees | ||||||
| Upfront 25% | 25,000.00 | Apr-14 | ||||
| Following SIV completion | 25,000.00 | Jun-14 | ||||
| Payments every 2 months thereafter based on exepditure | 25,000.00 | Aug-14 | ||||
| Payments every 2 months thereafter based on exepditure | 25,000.00 | Oct-14 | ||||
| 100,000.00 | ||||||
Change order no 1
Kitov/ Java MSA
Page 2 of 3
Appendix 2
PI Fees Northern Ireland
Paid and contracted directly to Celerion
| MSA Kitov/ Celerion | Euro | Sterling | ||||||
| Patient Management /PI Fees | € | 217,166.40 | £ | 180,972.00 | ||||
| Pass through costs | € | 6,000.00 | £ | 5,000.00 | ||||
| PK sampling | € | 17,323.20 | £ | 14,436.00 | ||||
| Total | € | 240,489.60 | £ | 200,408.00 | ||||
Change order no 1
Kitov/ Java MSA
Page 3 of 3
Master Services Agreement Dated
Between Kitov Pharmaceuticals Limited (Kitov)
and
Java Clinical Research Ltd ( JAVA)
|
CHANGE ORDER FORM (2)
| |
|
PROTOCOL NUMBER:
|
KIT-302-03-01 |
|
Kitov CONTACT:
|
Mr Simcha Rock |
|
SUPPLIER CONTACT:
|
▇▇ ▇▇▇▇ ▇▇▇▇▇▇ |
|
DATE OF REQUEST:
|
22 09 2014 |
|
BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST:
| |
|
IMPACT (estimated effort and/or timeline):
| |
COST: Total additional cost:
€ 96,716.34 Professional Fees € 9,968 Pass through Fees
Revised budget break down is included in Appendix 1. Costs will be revisited if recruitment is completed earlier than 27 March 2015 as detailed in the attached Appendix 1. |
| GRAND REVISED TOTAL PROFESSIONAL FEES | 664,799.58 | |||
| less received to date | 204,657.98 | |||
| Balance | 460,141.60 | |||
| 20% following 10 subjects randomised | 92,028.32 | |||
| 10 % following 30 subjects randomised | 46,014.16 | |||
| 10 % following 50 subjects randomised | 46,014.16 | |||
| 10 % following 75 subjects randomised | 46,014.16 | |||
| 10 % following 100 subjects randomised | 46,014.16 | |||
| 10 % following 125 subjects randomised | 46,014.16 | |||
| 10 % following 150 subjects randomised | 46,014.16 | |||
| 10% following LPLV | 46,014.16 | |||
| 5% following DB lock | 23,007.08 | |||
| 5% following final study Report | 23,007.08 | |||
| 460,141.60 |
| Amendment: This Change Order Form shall constitute a Contract Amendment to the MSA dated 04 February 2014 and Change Order No 1 dated 26 March 2014 between Kitov and Java. In all respects the terms and conditions of the MSA shall remain in full force and effect and shall be applied to this Contract Amendment No 2 | |
|
Kitov Pharmaceuticals Ltd
/s/ Simcha Rock (Signature)
September 23, 2014 (Date)
|
Java Clinical Research ltd
/s/ (Signature)
_________________________ (Date) |
Change order no 1
Kitov/ Java MSA
Page 1 of 5
Appendix 1
Revised Professional & Pass through fees
| Study Reference K-03-01 | |||||
| Projected Timelines: | |||||
| Project Preparation | 14 weeks | 18 weeks | January 2014 – Mid-May 2014 | ||
| Study Recruitment and Conduct Period | 22 weeks | 42 weeks | 22 June 2014 - 27 March 2015 | ||
| Close out period | 12 weeks | 30 March 2015 - 19 June 2015 | |||
| Indication: | Hypertension | ||||
| Key Assumptions: | |||||
| Number of patients to be screened | 300 | ||||
| Number of patients to be randomised | 150 | ||||
| Sites | 1 site NI 4 sites UK | ||||
| Number of monitoring visits | Estimated pool of 45 monitoring site visits | ||||
| Total CRF pages per patient | TBC | ||||
| ACTIVITY | RATE | UNIT | EST. REQ. | ESTIMATED CHARGE | Comments | |||||||||||
| € | Range | Range € | ||||||||||||||
| Project Preparation | ||||||||||||||||
| PM project training | 110.00 | hour | 16 | 1,760.00 | To include protocol, CRF and SOP training | |||||||||||
| CRA project training | 85.00 | hour | 16 | 1,360.00 | To include protocol, CRF and SOP training | |||||||||||
| PM project preparation time | 1,760.00 | week | 22 | 38,720.00 | Includes site contacts/feasibility assessments to ensure all required systems are in place for study initiation, assistance with eCRF development to include advice on required CRF data fields, communication with Kitov Ltd on project related progress/issue | |||||||||||
| PM Feasibility & Preparation UK sites | 880.00 | day | 12 | 10,560.00 | Site & laboratory feasibility and selection activities including budget and contract negotiations | |||||||||||
| CRA project preparation time | 1,360.00 | week | 14 | 19,040.00 | Includes site contacts/feasibility, communication with Kitov Ltd, collating all study related materials required for initiation, addressing site queries and issues, preparation/customisation of Investigator Study Files and Forms, collection of essential d | |||||||||||
| CTA project preparation time | 400.00 | week | 18 | 7,200.00 | ||||||||||||
| Preparation total | 78,640.00 | |||||||||||||||
| Regulatory and Ethics | ||||||||||||||||
| Review and submission of CTA to IMB (including submission of responses to any queries raised during review period) | 3,840.00 | submission | 1 | 3,840.00 | ||||||||||||
| Review and submission of CTA to MHRA (including submission of responses to any queries raised during review period) | 3,840.00 | submission | 1 | 3,840.00 | ||||||||||||
| Submission of Substantial Amendment to MHRA | 120.00 | hour | 38 | 4,560.00 | 12 hours Amen1: 8 hours ▇▇▇▇▇ 2 ; 16 hours Amen 3 :12 hours amendment 4 | |||||||||||
| Submission to National Ethics Committee in Northern Ireland (including submission of responses to any queries raised during review period) | 2,040.00 | submission | 1 | 2,040.00 | ||||||||||||
| Submission to National Ethics Committee in Northern Ireland (including submission of responses to any queries | 2,720.00 | submission | 1 | 2,720.00 | ||||||||||||
| Preparation and submission of substantial amendments to National Ethics Committee in Northern Ireland | 880.00 | submission | 7 | 6,160.00 | ||||||||||||
| Management of R&D Office Approval, including budget negotiation | 1,760.00 | site | 1 | 1,760.00 | ||||||||||||
Change order no 1
Kitov/ Java MSA
Page 2 of 5
| Regulatory total | 24,920.00 | Estimate 13 Belfast visits; 32 UK visits | ||||||||||||||
| Clinical Operations | Assuming 1 Belfast Centre: 4 UK Regional Centres - estimated Monitoring Visit Pool of 45 visits ( 12 visits Belfast : 32UK)) | |||||||||||||||
| Site Qualification Visits | 680.00 | site | 10 | 6,800.00 | Site Visit preparation time for pre study visits - 2 hours. Site Visit preparation time for SIV and close out visit - 4 hours. Site Qualification and Pre study visit duration - 4 hours. SIV and close out visit duration - 8 hours. Monitoring Visits pre | |||||||||||
| Travel time | 400.00 | site | 6 | 2,400.00 | ||||||||||||
| Site Qualification Visits UK | 680.00 | site | 4 | 2,720.00 | ||||||||||||
| Travel time UK | 600.00 | site | 4 | 2,400.00 | ||||||||||||
| Pre-Study Visits | 850.00 | site | 5 | 4,250.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 1 | 200.00 | ||||||||||||
| Travel time UK | 600.00 | visit | 4 | 2,400.00 | ||||||||||||
| Site Initiation Visits | 1,360.00 | site | 5 | 6,800.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 1 | 200.00 | ||||||||||||
| travel time UK | 600.00 | visit | 4 | 2,400.00 | ||||||||||||
| Study Monitoring Visits | 2,040.00 | site | 45 | 91,800.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 13 | 2,600.00 | ||||||||||||
| Travel time UK | 600.00 | visit | 32 | 19,200.00 | ||||||||||||
| Study Close-Out Visits | 1,360.00 | site | 5 | 6,800.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 1 | 200.00 | ||||||||||||
| Travel time UK | 600.00 | visit | 4 | 2,400.00 | ||||||||||||
| CRA Site Management | 340.00 | week | 18 | 6,120.00 | June - Sept 2014 | |||||||||||
| CRA Site Management | 850.00 | week | 24 | 20,400.00 | Oct - March 2015 | |||||||||||
| CRA Site Management | 850.00 | week | 12 | 10,200.00 | Close out period | |||||||||||
| Project Management | 2,200.00 | week | 52 | 114,400.00 | Internal management of CRAs including advice on recruitment strategies, site related issues, contingency measurement implementation etc; Communication with Kitov Ltd on project progress/study related issues; Management of Third Party Vendors; Management o | |||||||||||
| CTA study conduct | 320.00 | week | 52 | 16,640.00 | Assistance with compilation of return of essential dcoument for TMF, CRA travel arrangements, collation of all pass through costs and study related invoices. |
Change order no 1
Kitov/ Java MSA
Page3 of 5
| Clinical Operations | 321,330.00 | |||||
| Other Services | ||||||
| Clinical Laboratory Services (Estimate) | ||||||
| Central Laboratory set up Fee | 5,874.00 | ACM laboratory contracted directly with Kitov | ||||
| Data Management and Statistics | ||||||
| Biometrics Management | 11,172.00 | |||||
| Data Management | 42,873.50 | |||||
| Amendment 1-3 | 5,133.50 | |||||
| Amendment 4 | 27,522.00 | |||||
| eCRF management and hosting | 64,189.25 | |||||
| Statistics | 37,225.75 | |||||
| 188,116.00 | ||||||
| Pharmacovigilance | ||||||
| Safety Database Maintenance | 4,000.00 | |||||
| PhV Specifications | 2,910.00 | |||||
| SAE Initial/Follow-up Report Processing | 3,600.00 | |||||
| Expedite SUSARs reporting | 108.00 | |||||
| Line Listing production | 2,440.00 | |||||
| Responsible Person - Eudravigilance | 6712.5 | |||||
| Pharmacovigilance Subtotal | 19,770.50 | |||||
| Medical Writing | ||||||
| Clinical Study Report | 14,252.00 | |||||
| Other Services Subtotal | 222,138.50 | |||||
| 8% overhead | 17,771.08 | |||||
| Preparation Regulatory & Clinops Subtotals | 424,890.00 | |||||
| GRAND TOTAL PROFESSIONAL FEES | 664,799.58 |
| Other study conduct costs | ||||||
| IMB CTA | 1,443.00 | |||||
| MHRA CTA + amendments | 5,000.00 | |||||
| Ethics Committe Fees | 3,500.00 | |||||
| CRA Travel | 28,200.00 | Belfast site: 1 sites x 4 visits x €300 = €1200 (SQV/PS/SIV/C0) | ||||
| Belfast site: 1 x 13 visits x €300 = 3900 | ||||||
| UK sites: 4 sites x 4 visits €500 =€8000 (SQV/PS/SIV/C0) | ||||||
| UK sites: 32 x €500 = €16000 | ||||||
| Courier Costs - as per receipted expenses | 8,000.00 | Estimate | ||||
| Stationary, Printing, Photocopying for TMF, Investigator Site Files and Ethics Applications ; other | 10,000.00 | |||||
| Management of PI fees | 9,885.00 | |||||
| Estimate other pass through costs | 66,028.00 |
Change order no 1
Kitov/ Java MSA
Page 4 of 5
| GRAND TOTAL PROFESSIONAL FEES | 664,799.58 | |||
| less received to date | 204,657.98 | |||
| Balance | 460,141.60 | |||
| 20% following 10 subjects randomised | 92,028.32 | |||
| 10 % following 30 subjects randomised | 46,014.16 | |||
| 10 % following 50 subjects randomised | 46,014.16 | |||
| 10 % following 75 subjects randomised | 46,014.16 | |||
| 10 % following 100 subjects randomised | 46,014.16 | |||
| 10 % following 125 subjects randomised | 46,014.16 | |||
| 10 % following 150 subjects randomised | 46,014.16 | |||
| 10% following LPLV | 46,014.16 | |||
| 5% following DB lock | 23,007.08 | |||
| 5% following final study Report | 23,007.08 | |||
| 460,141.60 |
Change order no 1
Kitov/ Java MSA
Page 5 of 5
Master Services Agreement Dated
2nd April ▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇ Pharmaceuticals Limited (Kitov)
and
Java Clinical Research Ltd ( JAVA)
|
CHANGE ORDER FORM (3)
| |
|
PROTOCOL NUMBER:
|
KIT-302-03-01 |
|
Kitov CONTACT:
|
Mr Simcha Rock |
|
SUPPLIER CONTACT:
|
▇▇ ▇▇▇▇ ▇▇▇▇▇▇ |
|
DATE OF REQUEST:
|
2nd April 2015 |
BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST:
| · Project
timelines have been extended as follows: 8 additional weeks in the study conduct 8 weeks interim analysis |
| · | The
budget is now reflective of up to 30 additional patients. |
| · | The Monitoring visit schedule has been restructured. The total monitoring visits have increased from 45 to 56; 40 of which are two day visits and 16 are one day visits. |
| · | 3
additional sites in the UK have been included; the budget reflects additional site feasibility assessments and initiation and
close out visits allocated to these new sites. |
| · | Protocol amendments were issued to facilitate recruitment. This resulted in the submission of multiple substantial amendment to the UK REC and MHRA. It also resulted in modifications to the eCRF and data management plan. Additionally REC approval, by means of submission of a substantial amendment to the REC, was required for each of the additional UK sites. |
|
IMPACT (estimated effort and/or timeline): As stated above
| |
COST: Total additional cost:
€116,238.18
Revised budget break down is included in Appendix 1. |
Page 1 of 5
| GRAND TOTAL PROFESSIONAL FEES | 781,037.76 | |||
| Less received to date | 388,714.62 | |||
| Invoice due for payment 30 March 2015 | 46,014.16 | |||
| 434,728.78 | ||||
| Balance Due | 346,308.98 | |||
| Revised Payment schedule ( based on montly resources) | ||||
| 30-Apr-15 | 76,957.50 | |||
| 30-Jun-15 | 76,957.50 | |||
| 30-Aug-15 | 76,957.50 | |||
| 30-Oct-15 | 76,957.50 | |||
| 30-Dec-15 | 38,478.98 | |||
| 346,308.98 | ||||
| Amendment: This Change Order Form shall constitute a Contract Amendment to the MSA dated 04 February 2014, Change Order No 1 dated 26 March 2014 and Change Order 2 dated 22 September 2014 between Kitov and Java. In all respects the terms and conditions of the MSA shall remain in full force and effect and shall be applied to this Change Order No 3. | |
|
Kitov Pharmaceuticals Ltd
/s/ Simcha Rock (Signature)
April 2, 2015 (Date)
|
Java Clinical Research ltd
/s/ ▇▇▇▇ ▇▇▇▇▇▇ (Signature)
02 April 2015 (Date) |
Change order no 1
Kitov/ Java MSA
Page 2 of 5
Appendix 1
Revised Professional fees
| Study Reference K-03-01 | |||||
| Agreed V8 | Revised V9 | ||||
| Projected Timelines: | |||||
| Project Preparation | 18 weeks | January 2014 – Mid-May 2014 | |||
| Study Recruitment and Conduct Period | 42 weeks | 50 weeks | 22 June 2014 - 05 June 2015 | ||
| Interim Analysis Recruitment and Conduct Period | 8 | 08 June - 03 AUG | |||
| Close out period | 12 weeks | 12 weeks | 03 AUG - 2 Nov | ||
| Indication: | Hypertension | ||||
| Key Assumptions: | |||||
| Number of patients to be screened | 300 | 400 | |||
| Number of patients to be randomised | 150 | 150 | |||
| Number of patients randomised during interim analysis | 30 | ||||
| Sites | 5 sites | 8 Sites | |||
| Number of monitoring visits (180 patients) | Estimated pool of 56 monitoring site visits | ||||
| Total CRF pages per patient | TBC | ||||
Change order no 1
Kitov/ Java MSA
Page 3 of 5
| ACTIVITY | RATE | UNIT | EST. REQ. | ESTIMATED CHARGE | Comments | |||||||||||
| € | Range | Range € | ||||||||||||||
| Project Preparation | ||||||||||||||||
| PM project training | 110.00 | hour | 16 | 1,760.00 | To include protocol, CRF and SOP training | |||||||||||
| CRA project training | 85.00 | hour | 16 | 1,360.00 | To include protocol, CRF and SOP training | |||||||||||
| PM project preparation time | 1,760.00 | week | 22 | 38,720.00 | Includes site contacts/feasibility assessments to ensure all required systems are in place for study initiation, assistance with eCRF development to include advice on required CRF data fields, communication with Kitov Ltd on project related progress/issue | |||||||||||
| PM Feasibility & Preparation UK sites | 880.00 | day | 12 | 10,560.00 | Site & laboratory feasibility and selection activities including budget and contract negotiations | |||||||||||
| CRA project preparation time | 1,360.00 | week | 14 | 19,040.00 | Includes site contacts/feasibility, communication with Kitov Ltd, collating all study related materials required for initiation, addressing site queries and issues, preparation/customisation of Investigator Study Files and Forms, collection of essential d | |||||||||||
| CRA project preparation time | 2,040.00 | site | 3 | 6,120.00 | additional 3 sites | |||||||||||
| CTA project preparation time | 400.00 | week | 18 | 7,200.00 | ||||||||||||
| Preparation total | 84,760.00 | |||||||||||||||
| Regulatory and Ethics | ||||||||||||||||
| Review and submission of CTA to IMB (including submission of responses to any queries raised during review period) | 3,840.00 | submission | 1 | 3,840.00 | ||||||||||||
| Review and submission of CTA to MHRA (including submission of responses to any queries raised during review period) | 3,840.00 | submission | 1 | 3,840.00 | ||||||||||||
| Submission of Substantial Amendment to MHRA | 120.00 | hour | 38 | 4,560.00 | 12 hours Amen1: 8 hours ▇▇▇▇▇ 2 ; 16 hours Amen 3 :12 hours amendment 4 | |||||||||||
| Submission to National Ethics Committee in Northern Ireland (including submission of responses to any queries raised during review period) | 2,040.00 | submission | 1 | 2,040.00 | ||||||||||||
| Submission to National Ethics Committee in Northern Ireland (including submission of responses to any queries | 2,720.00 | submission | 1 | 2,720.00 | ||||||||||||
| Preparation and submission of substantial amendments to National Ethics Committee in Northern Ireland | 880.00 | submission | 12 | 10,560.00 | ||||||||||||
| Preparation and submission of non substantial amendments to National Ethics Committee in Northern Ireland | 220.00 | submission | 25 | 5,500.00 | ||||||||||||
| Management of R&D Office Approval, including budget negotiation | 1,760.00 | site | 1 | 1,760.00 | ||||||||||||
| Submission fo R&D Office Amendment including revised budget negotiaition for QMUH | 880.00 | site | 1 | 880.00 | ||||||||||||
| Regulatory total | 35,700.00 | |||||||||||||||
| Clinical Operations | ||||||||||||||||
| Site Qualification Visits | 680.00 | site | 10 | 6,800.00 | Site Visit preparation time for pre study visits - 2 hours. Site Visit preparation time for SIV and close out visit - 4 hours. Site Qualification and Pre study visit duration - 4 hours. SIV and close out visit duration - 8 hours. Monitoring Visits prep | |||||||||||
| Travel time | 400.00 | site | 6 | 2,400.00 | ||||||||||||
| Site Qualification Visits UK | 680.00 | site | 4 | 2,720.00 | ||||||||||||
| Travel time UK | 600.00 | site | 4 | 2,400.00 | ||||||||||||
| Pre-Study Visits | 850.00 | site | 8 | 6,800.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 1 | 200.00 | ||||||||||||
| Travel time UK | 200.00 | visit | 4 | 800.00 | ||||||||||||
| Site Initiation Visits | 1,360.00 | site | 8 | 10,880.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 1 | 200.00 | ||||||||||||
| travel time UK | 200.00 | visit | 7 | 1,400.00 | ||||||||||||
| Study Monitoring Visits (2 day visits) | 2,040.00 | site | 40 | 81,600.00 | ||||||||||||
| Study Monitoring Visits (1 day visits) | 1,360.00 | site | 16 | 21,760.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 7 | 1,400.00 | ||||||||||||
| Travel time UK | 200.00 | visit | 49 | 9,800.00 | ||||||||||||
| Study Close-Out Visits | 1,360.00 | site | 8 | 10,880.00 | ||||||||||||
| Travel time Belfast | 200.00 | visit | 1 | 200.00 | ||||||||||||
| Travel time UK | 200.00 | visit | 7 | 1,400.00 | ||||||||||||
| CRA Site Management | 340.00 | week | 18 | 6,120.00 | June - Sept 2014 (2 sites) | |||||||||||
| CRA Site Management | 510.00 | week | 12 | 6,120.00 | Oct - Dec 2014 (5 sites) | |||||||||||
| CRA Site Management | 680.00 | week | 28 | 19,040.00 | Jan - Aug 2015(8 sites) 1 hour per site per week | |||||||||||
| CRA Site Management | 1,360.00 | week | 12 | 16,320.00 | Close out period 2 hours per site per week | |||||||||||
| Project Management | 2,200.00 | week | 70 | 154,000.00 | Internal management of CRAs including advice on recruitment strategies, site related issues, contingency measurement implementation etc.; Communication with Kitov Ltd on project progress/study related issues; Management of Third Party Vendors; Management | |||||||||||
| CTA study conduct | 320.00 | week | 70 | 22,400.00 | Assistance with compilation of return of essential document for TMF, CRA travel arrangements, collation of all pass through costs and study related invoices. | |||||||||||
Change order no 1
Kitov/ Java MSA
Page 4 of 5
| Clinical Operations | 385,640.00 | |||||
| Other Services | ||||||
| Clinical Laboratory Services (Estimate) | ||||||
| Central Laboratory set up Fee | 5,874.00 | ACM laboratory contracted directly with Kitov | ||||
| Clinical Laboratory Services (Estimate) total | 5,874.00 | |||||
| Data Management and Statistics | ||||||
| Biometrics Management | 15,361.00 | |||||
| Data Management | 52,313.50 | |||||
| Statistics | 37,225.75 | |||||
| Amendment 1-3 | 5,133.50 | |||||
| Amendment 4 | 27,522.00 | |||||
| eCRF management and hosting | 82,148.75 | |||||
| Data Management and Statistics total | 219,704.50 | |||||
| Pharmacovigilance | ||||||
| Safety Database Maintenance | 6,857.50 | |||||
| PhV Specifications | 2,910.00 | |||||
| SAE Initial/Follow-up Report Processing | 3600 only if SAE | |||||
| Expedite SUSARs reporting | 108.00 | |||||
| Line Listing production | 2,440.00 | |||||
| Responsible Person - Eudravigilance | 8,300.00 | |||||
| Pharmacovigilance total | 20,615.50 | |||||
| Medical Writing | ||||||
| Clinical Study Report | 14,252.00 | |||||
| Medical Writing total | 14,252.00 | |||||
| Other Services Subtotal | ||||||
| Summary | ||||||
| Preparation total | 84,760.00 | |||||
| Regulatory total | 35,700.00 | |||||
| Clinical Operations total | 385,640.00 | |||||
| Other Services total | 254,572.00 | |||||
| 8% overhead | 20,365.76 | |||||
| GRAND TOTAL PROFESSIONAL FEES | 781,037.76 |
Change order no 1
Kitov/ Java MSA
Page 5 of 5