AMENDEMENT No. 2 TO CLINICAL TRIAL AGREEMENT
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AMENDEMENT No. 2 TO CLINICAL TRIAL AGREEMENT
This AMENDMENT NO. 2 TO CLINICAL TRIAL AGREEMENT (the "Amendment 2") is made and entered into as of the 28th day of January, 2004, by and between Gentium S.p.A. (formerly Crinos Industria Farmacobiologica S.p.A.) a corporation having an office at Xxxxxx XX Xxxxxxxxx 0, 00000 Xxxxx Xxxxxxx, Xxxx Xxxxx (the "Company") and Xxxx-Xxxxxx/Partners Cancer Care, Inc., a non-profit corporation having an office at 00 Xxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx, 00000, XXX ("DFPCC").
WHEREAS, the Company and DFPCC entered into a Clinical Trial Agreement dated December 27, 1999 (the "Clinical Trial Agreement") and an Amendment No. 1 to Clinical Agreement in October 2000 (the "Amendment"), which relates to the conduct of a clinical study of Defibrotide in accordance with the study protocol entitled "Defibrotide for Hematopoietic Stem Cell Transplant (SCT) Patients with Severe Hepatic Xxxx-Occlusive Disease (VOD): A Randomized Phase I/II Study to Determine the Effective Dose;" and
WHEREAS, the parties desire to expand the number of subjects participating in the Study.
NOW, THEREFORE, in consideration of the mutual agreements, promises and covenants provided herein, the Company and DFPCC hereby agree to amend the Clinical Trial Agreement as follows:
Section 1: Budget
With reference to Section 4: Budget of the Clinical Trial Agreement, this section is hereby amended to include an additional Two hundred thousand U.S. Dollars ($200,000) and restated in its entirety to read as follows:
Company agrees to support this Study with a research grant of Four hundred fifty thousand U.S. Dollars ($450,000) inclusive of indirect costs. The agreed upon budget is attached hereto as Exhibit B.
IN WITNESS WHEREOF, THE COMPANY AND DFPCC have by their own hands or by their respective officers executed the Amendment No. 2 to Clinical Trial Agreement effective as of the date first set forth above.
| THE COMPANY: CRINOS INDUSTRIA FARMACOBIOLOGICA S.P.A. |
DFPCC: XXXX-XXXXXX/PARTNERS CANCER CARE, INC. |
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GENTIUM S.P.A. |
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BY: |
/s/ Xxxxx Xxxx Xxxxx |
BY: |
/s/ Xxxxxx X. Xxxxxxx, Xx. |
|
TITLE: |
PRESIDENT |
TITLE: |
XXXXXXX X. XXXXXXX, XX. DIRECTOR OF RESEARCH ADMINISTRATION |
|
DATE: |
March 19, 2004 |
DATE: |
2/9/04 |
|
I have read the foregoing Amendment No. 2 and agree to comply with the obligations of Investigators stated therein.
/s/ Xxxx Xxxxxxxxxx Xxxx Xxxxxxxxxx, M.D. |
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DATE: |
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"Diferotide
for Hematopoietic Stem Cell Transplant (STC) Patients with Severe Hepatic Xxxx-Occlusive Disease
(VOA): A Phase I/II Study to Determine Minimal Effective Dose"
| Protocol No Duration of Study (months) Number of Patients |
99-118 12 20 (total of 80pts) |
Company Name Overall Site Overall P.I. Site P.I. |
CRINOS DFCI XXXXXXXXXX, MD |
||||||
|---|---|---|---|---|---|---|---|---|---|
| BUDGET ITEMS |
Percent Effort |
Study Total |
Amount Per Patient |
||||||
| PERSONNEL: | |||||||||
| Site Principal Investigator | 11% | $ | 16,512 | $ | 826 | ||||
| Project Manager | 45% | $ | 25,775 | $ | 1,289 | ||||
| Data Manager (Xxxxxx Xxxxxx) | 100% | $ | 38,272 | $ | 1,914 | ||||
| Research Nurse | 0% | $ | 0 | $ | 0 | ||||
| Total Salaries | $ | 80,559 | $ | 4,028 | |||||
| Employee Benefits M.D. | 29.00% | $ | 4,789 | $ | 239 | ||||
| Employee Benefits Non-M.D. | 26.00% | $ | 16,652 | $ | 833 | ||||
| Total Benefits | $ | 21,441 | $ | 1,072 | |||||
| TOTAL PERSONNEL | $ | 102,000 | $ | 5,100 | |||||
OUTPATIENT CARE COSTS |
|||||||||
| Tests/Procedures, etc. | $ | 0 | $ | 0 | |||||
| Subtotal Outpatient Care | $ | 0 | $ | 0 | |||||
| INPATIENT CARE COSTS | |||||||||
| Bed Day Rates | None | ||||||||
| Other Procedures | $ | 0 | $ | 0 | |||||
| Subtotal Inpatient Care | $ | 0 | $ | 0 | |||||
PHARMACY: Prep, Storage, etc. |
Pharmacy Charge Form |
$ |
0 |
$ |
0 |
||||
| TOTAL PATIENT CARE | $ | 0 | $ | 0 | |||||
| Pharmacokinetics | DFCI/MGH/Other ý ý ý |
$ | 50,000 | $ | 2,500 | ||||
| TOTAL PHARMACOKINETICS* | $ | 50,000 | $ | 2,500 | |||||
| *Includes set-up charge of $15,000 at Childrens Hospital | |||||||||
OTHER EXPENSES |
|||||||||
| Supplies | $ | 1,000 | $ | 50 | |||||
| Shipping Costs | $ | 0 | $ | 0 | |||||
| Travel (Protocol or Scient. Mtgs) | $ | 2,500 | $ | 125 | |||||
| Equipment | $ | 0 | $ | 0 | |||||
| Shared Resources (eg, MDLab) | $ | 0 | $ | 0 | |||||
| Storage Fees | $ | 0 | $ | 0 | |||||
| CER Lab | $ | 4,500 | $ | 225 | |||||
| TOTAL OTHER EXPENSES | $ | 8,000 | $ | 400 | |||||
| TOTAL DIRECT COSTS: | $ | 160,000 | $ | 8,000 | |||||
| Indirect Costs @ 25% Total Direct Costs | $ | 40,000 | $ | 2,000 | |||||
| TOTAL COSTS PER PATIENT** | $ | 200,000 | $ | 10,000 | |||||
Protocol Review and Renewals |
$ |
0 |
|||||||
| Start-Up Costs | $ | 0 | |||||||
| TOTAL STUDY COSTS** | $ | 200,000 | |||||||
**Includes payments to sub-contract sites
