Document Z4bjmY8v7dXqkMEpzpBmDVyQ7
From: Sent: To: Cc:
Subject:
Attach:
Russell White <whiter@api.org> Wednesday, May 23, 2007 3:44 PM (GMT) BenzConsort-OC@listserve.api.org; BenzConsort-TC@listserve.api.org Bob Greco <Greco@api.org>; Brenda Hargett <Hargettb@api.org>; Harry Ng <Ng@api.org>; Linda Kangas <Kangas@api.org> Shanghai Health Study - conference calls for Thursday, May 24 at 1:30 PM EDT and Friday, May 25 at 12:30 PM EDT uchsc_01-0000-4788. pdf
Please mark your calendar - the BHRC Oversight Committee has scheduled conference calls for Thursday, May 24 at 1:30 PM EDT and Friday, May 25 at 12:30 PM EDT.
The current grant and grant amendments between API and the University of Colorado are attached for your review.
Draft agenda for calls. 1) Establish quorum and notetaker - Patsy 2) Antitrust reminder - Mark or John 3) Discuss the University of Colorado grant extension- All 4) Discuss the draft contract with Cinpathogen - All
Conference call information:
Toll Free Dial-In Number: (866) 443-0059 International Dial-In: (770) 765-9147
Enter this code at the prompt: 2026828344# Operator-Assisted Service:
Toll-Free Dial-In Number: (800) 572-9844 International Dial-In Number: (706) 643-1733 Call Participant Functions *0 Operator assistance *6 Mute your own line
uchsc_01-0000-4788. pdf
Russell White
Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005-4070
Tel: 202-682-8344 Fax: 202-682-8270
SHELL-MCCLURG-053811
American Petroleum Institute
1220 L Street, Northw( Washington, DC 2000;...070
Tel 202-682-8340 Fax 202-682-8270 E-mail feldman@apLorg
Howard Feldman Director Research Analysis and Scientific Affairs
October 16, 2001
Dr. Richard Irons Health Sciences Center University of Colorado Campus Box C238 4200 East Ninth Avenue Denver, CO 80262
API Reference No. 01-0000-4788 Amendment No.1 01-0000-4804
Dear Dr. Irons:
The October 2,2001 grant agreement between the American Petroleum Institute ("API"), as the representative for the Benzene Health Research Consortium, and the University of Colorado Health Sciences Center (UCHSC), for a five-year research study of Iymphohematopoietic health risks from occupational exposure to benzene in the Peoples Republic of China, is amended as follows:
1. Paragraph 1(ii) is amended to include the Children's Hospital Medical Center of Cincinnati as a cooperative entity.
2. Paragraph 1(vii) is amended by replacing the current paragraph with the following text:
Dr. Richard Irons will provide biannual progress reports as provided by the research proposal. UCHSC will prepare and provide biannual financial reports of expenditures made by UCHSC. Biannual reports are due January and July of each calendar year. Continuance of funding is contingent upon API approval of these biannual reports.
3. Paragraph 3 is amended by replacing the current paragraph with the following text:
API, however, reserves the right to terminate this Grant by giving thirty (30) days notice of such
termination to UCHSC. Upon receipt of such notice of termination, UCHSC shall cease incurring
costs on this project, except with the prior approval of API, which shall not be unreasonably
withheld, for such costs that are necessary to close out the project. In the event of such
termination, API's sole obligation will be to reimburse UCHSC for actual costs incurred, including
UCHSC's legal commitments to third parties for activities under this grant agreement, as of the
date of termination, and subsequent costs incurred with prior approval of API. However, API
shall not be responsible for third -party obligations that UCHSC incurs more than one year
following termination of this Grant agreement. Furthermore, UCHSC agrees to use its best
efforts to minimize the duration of its third-party obligations under this agreement. In no event
shall such payment include costs and/or anticipated fees for unperformed work or exceed the
maximum amount of the annual Grant disbursement for the year in which the Grant is
terminated.
.
In all other respects, the terms and conditions of the October 2,2001 grant agreement shall remain in full force and effect.
An equal opportunity employer
SH ELL-MCCLU RG-053812
University of Colorado
)
Reference No. 01-0000-4788
Page 2
.~
\
If the foregoing is acceptable, please sign below and return one copy of this letter to API.
UNIVERSITY OF COLORADO
AMERICAN PETROLEUM INSTITUTE
Howard J. F dman
Regulatory, nalysis & Scientific Affairs Director
Date Brenf:dett~l Chief Financial Officer
Date
SHELL-MCCLURG-053813
American Petroleum Institute
)
1220 LStreet, 1\ 'Awest
Washington, DC 20005-4070 202-682-8100
Red Cavaney President and CEO
Dr. Richard Irons Health Sciences Center University of Colorado Campus Box C238 4200 East Ninth Avenue Denver, CO 80262
Dear Dr. Irons:
API Reference No. 01-0000-4788
The American Petroleum Institute ("API"), as the representative for the Benzene Health Research Consortium, is pleased to provide a Grant totaling $13,665,017.00 to fund the University of Colorado Health Sciences Center's ("UCHSC") five~year research study of Iymphohematopoietic health risks from occupational exposure to 'benzene in the Peoples Republic of China. This Grant is being provided to accomplish the research as set forth in the most recent versions of the "Research Protocol and Criteria Document established by the investigators and approved by the review panels as specified in paragraph iv below and the budget approved by the Benzene Health Research 'Consortium for this program.
1. Grant monies will be disbursed to UCHSC according to the following schedule:
,-~
30% in Year One (payable in two installments) 25% in Year Two 15% in Year Three 15% in Year Four 15% in Year Five
subject to the following conditions:
i. UCHSC acknowledges that the research study will be conducted consistent with the research proposal and budget developed by the Principal Investigator and the Benzene Health Research Consortium.
ii. UCHSC will establish cooperative agreements with Fudan University in Shanghai, China; the Shanghai Municipal Center for Disease Control and Prevention; the Shanghai Municipal Institute for Public Health Supervision; and Exxon Mobil Biomedical Sciences in Annandale, N.J. (collectively known as "cooperative entities") to assist in performance of the research study.
SHELL-MCCLURG-053814
University of Colorado ,.
API Reference No. 01-0000-4788 Page 2
...
iii. It is recognized that payments made by UCHSC to the cooperative entities
will be of a pass through nature and that UCHSC will not be responsible for the management of such contracts. It is also recognized that the agreements with Fudan University in Shanghai, the Shanghai Municipal Center for Disease Control and Prevention, and the Shanghai Municipal Institute for Public Health Supervision will not involve cost accounting of funds transferred as part of this Grant given the nature of those institutions and the reporting otherwise provided by the Principal Investigator pursuant to the research proposal and budget.
iv. UCHSC acknowledges that the protocols and conduct of the research during the life of the Grant are subject to annual review and approval by an independent scientific review panel as well as by an ethics review panel, both of which will be established by API. These panels shall be notified immediately when a change in protocol is proposed. No significant changes in protocol that would effect the scope of work will be exercised without approval by both the scientific review panel and ethics review panel.
v. API, or an agent or representative of API, will have access to, and may periodically review, the record of funds disbursed by UCHSC as part of the research study, including disbursements by UCHSC to the cooperative entities.
vi. Dr. Richard Irons, the Principal Investigator, will have budget authority to reallocate funds between and among different budget categories and may authorize the transfer of funds to the cooperative entities identified in this agreement, provided the Grant monies disbursed to UCHCS are used and expended consistent with the research program and operating budget proposed by, and as may necessarily be modified by, API.
vii. Dr. Richard Irons will provide satisfactory biannual reports of all expenditures, as provided by the research proposal and budget. Biannual reports are due January and July of each calendar year. Continuance of funding is contingent on API approval of these biannual reports.
viii. The research study and expenditure of the Grant monies are in compliance with all applicable laws, both foreign and domestic, including the United States Foreign Corrupt Practices Act.
2. This Grant shall be effective upon signature of Grantee below and shall terminate on December 31 , 2006.
3. API, however, reserves the right to terminate this Grant by giving thirty (30) days notice of such termination to llCHSC. Upon receipt of such notice of termination, UCHSC shall cease incurring costs on this project, except with the prior approval of
SHELL-MCCLURG-053815
University of Colorado ., API Reference No. 01-0000-4788 Page 3
I
.. !
API for such costs on this project, which are necessary to close out the project. In the event of such termination, API's sole obligation will be to reimburse UCHSC for actual costs incurred as of the date of termination and such subsequent costs incurred with prior approval of API. In no event shall such payment include costs and/or anticipated fees for unperformed work or exceed the maximum amount of the annual Grant disbursement for the year in w~ich the Grant is terminated.
4. It is understood that if any of the funds provided under this Grant are not used for
this project by the termination date, Grantee shall return such unused funds to API.
If the terms of the Grant agreement are acceptable, please sign both copies and return one to API.
UNIVERSITY OF COLORADO 8y: __________________
TITUTE
Date:,________________
By: Awcl1uJ4td G. William Frick Vice President, General Counsel & Secretary
lollDate: 10 b)
SH ELL-MCCLU RG-053816
American Petroleum Institute
\,
!
1220 L Street, Northwest Washington, DC 20005-4070 202-6828100
Red Cavaney President and CEO
Dr. Richard Irons Health Sciences Center University of Colorado Campus Box C238 4200 East Ninth Avenue Denver, CO 80262
API Reference No. 01-0000-4788 Amendment No.2
Dear Dr. Irons:
The October 2,2001 grant agreement between the American Petroleum Institute ("API"), as the representative for the Benzene Health Research Consortium, and the University of Colorado Health Sciences Center (UCHSC), for a five-year research study as described in the research protocols, "Analysis of Disease Progression for Aplastic Anemia, Myelo-Dysplastic Syndrome, Acute Myelogenous Leukemia and Benzene Poisoning in Shanghai, China" and "Molecular Epidemiology of Benzene-Exposed Workers in Shanghai, China," is further amended as follows:
1. The opening paragraph of the above grant agreement is modified as follows.
a. The grant amount is increased $842,983, from $13,665,017 to $14,508,000. b. The 5-year research study is now a 6-year research study.
2. Paragraph 1 of the grant agreement is modified as follows:
a. The following is the revised schedule for disbursement of grant monies to UCHSC:
$4,099,505 in Year 1 $3,416,254.25 in Year 2 $874,031 April 2004 $874,030 October 2004 $874,030 April 2005 $874,030 October 2005 $874,030 April 2006 $874,030 October 2006
$874,030 February 2007 $874,030 August 2007
b. Paragraph 1(vi) is replaced with the following:
Dr. Richard Irons, the Principal Investigator, will have budget authority to reallocate funds between and among different budget categories, and may authorize the transfer, disbursement or increase of funds to the cooperative entities identified in this agreement, provided the Grant monies disbursed to UCHSC are used and expended consistent with the research program protocols and with the operating budget proposed by, and as may necessarily be modified by, API. This authority includes the amendment of agreements with the cooperative entities.
An equal opportunity employer
SH ELL-MCCLU RG-053817
University of Colorado Reference No. 01-0000-4788, amendment #2 Page 2
c. Paragraph 1(vii) is replaced with the following:
Dr. Richard Irons will submit biannual progress reports as provided by the research proposal UCHSC will prepare, and will submit biannual financial reports of expenditures made by UCHSC. Biannual reports are due February 28 and August 15 of each calendar year. Continuance of funding is cOfltingent upon API approval of these biannual reports. If the biannual financial reports reveal more than 5% of the total disbursement amount to date remains uncommitted, API reserves the right to defer disbursement of the next scheduled payment until receiving a revised financial report from Dr. Irons indicating that the balance is below 5%. Pursuant to API policy, UCHSC shall credit interest earned on any uncommitted funds. UCHSC may pay such interest income directly to API or as a credit against API's next scheduled payment.
3. Paragraph 2 is modified as follows:
The Grant shall terminate on December 31,2007.
4. Paragraph 5 is added as follows:
Technical and administrative aspects of this grant agreement will be under the direction of Howard J. Feldman, Regulatory Analysis & Scientific Affairs Director, American Petroleum Institute, 1220 L Street, NW, Washington, D.C. 20005, or whomever he designates. The designated API representative for work conducted hereunder is Bruce Jarnot, Ph.D. UCHSC shall send all correspondence and reports relating to this agreement to Dr. Jarnot's attention at the foregoing address.
In all other respects, the terms and conditions of the October 2, 2001 grant agreement, as further amended, shall remain in full force and effect.
If the foregoing is acceptable, please sign below and return one copy of this letter to API.
UNIVERSITY OF COLORADO
AMERICAN PETROLEUM INSTITUTE
<::::
Twiia Fisl'-isr Rels;hley
Director. Grant~ clno Contracts
1$0/ 3Date:
0
Chief Financial Officer
Date: i7 Oe~ ZDD3
SHELL-MCCLURG-053818
..
~ American Petroleum Institute
---
Dr. Richard Irons St!I..nt'lI~J:l Canter
Campus
4200 East Ninth Avenue Denver. CO 80262
Dear Dr. Irons:
The October 2. 2001 grant agreement between the American Petroleum Institute ("API"). as the rapreeen1ative for 1he 8enzene HeaIm Research Consortium, and the Univel1i!ty of Colorado
Hearth Sciences Center (UCHSC). for a five-year research study of Iymphohematopoietlc health
risks from occupational exposure to benzene in the Peoples Republic of China, is further
amended as follows:
1. As agreed at the meeting with study sponsors, the grant amount remains $14.508.000.
2. Teating and case accumulation for the program are occurring more quiokly than anticipated. Consequently, the timing of program expenditures is being accelerated. resulting In the need to modify the dlsbul1iament schedule and study termination date.
S. Accordingly, the following is the reVised schedule for disbursement of grant monies to UCHSC. per paragraph 1 of the grant agreement:
Payment Timing
Year 1
Vaar2
Aprll2004 June2004
early disbursement of October 2004 payment
October 2004
.:_:~t(.; j~~~/
October 2006 April2006 October 2008
February 2007
Total
Payment
Amount
$4.099,605 $3,416.254
$874,031 $874.030
4. UCHSC will provide API a budget reanalysJs and accompanying cash flow statement by October 25. 2004.
SHELL-MCCLURG-053819
DRAFT
American Petroleum Institute
Statement of Operations Benzene Health Research Period Ended March 31, 2005
311412005, 10:48 AM
SP Special Solicitation Program 5200 Benzene Health Research X81 ** Program
Variance
Current Month
Favorable
Actual
Budgt!t_ (UnfavoraiJle)
Year to Date
Actual
Budget
Variance Favorable (Unfavorable)
Total 2005 Budget
Pending Contracts
Executed Contracts
Remaining 2005 Funds
Revenue 7601 Leveraged Research Revenue 7050 Interest Income
Total Revenue
121,750 121,750
(121,750) (121,750)
365,250 365,250
(365,250) (365,250)
1,461,000 10,000
1,471,000
(1,471,0bt,J
9010 9030 9110 9170 9941 9945 9946 9949
Operating Expenses Salaries Employee Benefits & PIR Taxes Employee Business Expenses Other Operating Expenses API Recovered Overhead API Allocated Costs Supported Expense/Subsidy Meetings Allocation
Total Operating Expenses
9*** Project Expenses
Total Expenses
4,827 4,827
2,899 322
859 2,333 1,500
250 8,163
8,163
2,899 322
859 2,333 1,500
250 8,163
(4,827)
3~36
12,554 1,569
60 682 3,515 4,667 3,000 500 26,547
177,183
203,730
7,542 838
1,512 2,235 7,000 4,500
750 24,376
2,622,000
2,646,376
(5,012) (731) (60) 830
(1,281) 2,333 1,500
250 (2,171)
2,444,817
2,442,646
27,000 3,000 8,000
20,000 8,000
28,000 18,000 3,000 115,000
2,622,000
2,737,000
96,629 96,629
1,611,021 1,611,021
14,446 1,431 7,940 19,318 4,485 23,333 15,000 2,500 88,453
737,166
825.619
Net Income(loss)
~,827)
- - - _.. _ - - -
113,587
(118,414)
(203,730) (2,281,126) . 2,077~96
(1,266,000)
(96,629) 1,611,021)
64.5~81 ====='" ""';
2,823,168 Beginning year fund balance
',,-">,/
Net transfers
2,619,438 Current fund balance
-----(J)
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Contract # 0100004788-0 0100004788-1 0100004788-2 0100004788-3
Contractor UNIVOFCO UNIV OF CO UNIV OF CO UNIVOFCO
Description
Amount
Payments Balance
GRANT AGREEMENT TO SE 7,515,759.25 7,515,759.25
0
amend#1 to Univ of CO grant 0 0 0
amend#2 to 01-4788, Univ of 2,622,091.00 2,622,091.00
0
amend#3 to 01-4788, Univof 0 0 0
10,137,850.25 10,137,850.25
0.00
~u 1~~(lotf
SHELL-MCCLURG-053821
American Petroleum Institute
Contractor: Contract#: Amendment #:
UNIVOFCO 0100004788 1
Contract Balance Report
Contract Officer: Contract Type: Start Date: End Date:
JARNOT, B Contract-Commitment Upon Signature Upon Completion
amend#1 to Univ of CO grant agreement for China benzene study. Changes to several paragraphs. No $ change.
Account Code
SP-5200-X8102-9991 Total
Amount 0.00
$0.00
Adjustments 0.00
$0.00
Account Code
Invoice Number
Payments 0.00
$0.00
I!I
Invoice Date
Accruals 0.00
$0.00
Invoice Amount
Balance Status 0.00 E
$0.00
Period
Account Code
Invoice Number
Invoice Date Invoice Amount Period
Account Code
Adjustment Number
Adj. Amount Description
Period
3/14/2005 1O:50:06AM
Page 1 of 1
SH ELL-MCCLU RG-053822
American Petroleum
JP Institute
Contractor: Contract#: Amendment #:
UNIVOFCO 0100004788 3
Contract Balance Report
Contract Officer: Contract Type: Start Date: End Date:
JARNOT, B Contract-Commitment Upon Signature 6/30/2007
amend#3 to 01-4788, Univ of CO grant for China benzene research. Testing'and case accumulation for the study are progressing more quickly than anticipated. Thus, this amendment is being done to modify the disbursement schedule to reflect the pace of expenditures. The amendment requires the university to submit a revised budget reanalysis and accompanying cash flow statement by 10/25/04.
Account Code SP-5200-X8105-9991
Total
Amount
Adjustments
Payments
Accruals
Balance Status
_ _ _ _ _:.;..00;;;..:... _ _ _ _ _.__ _ _ _ _ _O~..;;..OO~ _ _ _ _ _0_._0_0 _ _ _ _ _0_._00_ E
$0.00
$0.00
$0.00
$0.00
$0.00
Account Code
Invoice Number
Invoice Date Invoice Amount Period
Account Code
Invoice Number
Invoice Date Invoice Amount Period
Account Code
Adjustment Number
Adj. Amount Description
Period
3/14/2005 10:50:10AM
Page 1 of 1
American Petroleum Institute
)
1220 L Street, Northwest
Washington, DC 20005-4070 202-682-8100
RedCavaney President and CEO
Dr. Richard Irons Health Sciences Center University of Colorado Campus Box C238 4200 East Ninth Avenue Denver, CO 80262
ApI Reference No. 01-0000-4788 Amendment No.4
Dear Dr. Irons:
The October 2,2001 grant agreement between the American Petroleum Institute ("API"), as the representative for the Benzene Health Research Consortium, and the University of Colorado Health Sciences Center (UCHSC), for a five-year research study of Iymphohematopoietic health risks from occupational exposure to benzene in the Peoples Republic of China, is further amended as follows:
1. As agreed at the May 3, 2005 meeting with study sponsors, the grant amount is increased $3,824,769, from $14,508,000 to $18,332,769.
2. The following is the revised schedule for disbursement of grant monies to UCHSC, per Paragraph 1 of the grant agreement and the May 3, 2005 revised budget, attached and made a part hereof:
Payment Timing
Year 1 Year2 Year3 April2005 October 2005 April2006 October 2006 February 2007 Total
Payment Amount $4,099,505 $3,416,254 $2,622,091 $874,030 $2,750,000' $2,500,000/ $1,500,000 $570,889 $18,332,769
In all other respects, the terms and conditions of the October 2, 2001 grant agreement, as further amended, shall remain in full force and effect.
If the foregoing is acceptable, please sign below and return one copy of this letter to API.
An equal opportunity employer
SH ELL-MCCLU RG-053824
University of Colorado Reference No. 01-0000-4788-, amendment #3 Page 2
UNIVERSITY OF COLORADO
~~ He"l~n L Ray Conk~,' ::.:';(' '\'iLnager Grants anu Contracts
_~Date: _'l=-l-(--!4'tf-=-() _ __
AMERICAN PETROLEUM INSTITUTE
Chief Financial Officer
Date: _~ _.. I_.;_O_S _ _ _ _ __
SH ELL-MCCLU RG-053825
Benzene Health Research Consortium Budget May 3, 2005
UCHSC Projected expenses 2005 - 2007 and Revised Program Budget
2005
2006
2007
TOTALS
UCHSC Expenses
$1,217,148 $1,108,178 $406,114 $2,731,440
EMBSI subcontract expenses
$ 862,823 $ 931,939 $ 407,700 $2,202,462
Fudan subcontract expenses
$1,676,855 $1,651,285 $159,600 $3,487,740
Histology consultant expenses*
$3,000
$3,000
$6,000
Cincinnati Children's Hospital expenses IPHS expenses
$112,000 $12,000
$117,600 $0
$39,295 $0
$268,895
I
$12,000
UCHSC 12131/04 bank balance (subtract from expense projections for 2005 payment to UCHSC
(513,618)
($513,618)
Projected Expense Totals 2005-2007
_ _ _ _ ~,367,208 ~3~12,002 $1,015,709 $8,194,919
2004 (amend 3) Payment Schedule
[Increase in expense OvercurrentPaymerit schedule Total paid to UCHSC as of 12131/04 Revised UCHSC program budget***
$1,748,060 $1,748,060 $874,030 $4,370,150
$1,619, 148
I$2,OO3,942-$14f,679~$3,824, 769
$10,137,850
1$18,332,7691
API revised payment schedule
Apr-05
$874,030
Oct-05
$2,750,000
Apr-06
$2,500,000
Oct-06
$1,500,000
Feb-07
$570,889
Total
$8,194,919
",-,.....",...'"
(J) * Histology consultant included since this service is a subcontract for the DP/ME studies.
I Payment for 2006 & 2007 should be made by UCHSC (2005 pmt already made by API)
m
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** 2007 costs for Cincinnati Children'S Hospital did not appear to be included in Jan 2005 progress report figures
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() ***(Paid as of 12131/04) + (total 2005-7 projected expenses)
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Final 5/6/05 Revised 7/18/05
~ University of Colorado hIth Sciences Center
School of Pharmacy Molecular Toxicology and Environmental Health Sciences Program Campus Box C238 4200 East Ninth Avenue Denver, Colorado 80262 303-315-7170 303-315-7223 Fax
August 8, 2005 Dr. Bruce Jarnot American Petroleum Institute 1220 L Street, NW (Suite 900) Washington, DC 20005-4070 Dear Bruce, Enclosed you will find one original fully executed amendment between American Petroleum Institute and the University of Colorado Health Sciences Center. We appreciate your continued support.
S{in/ceirelly!', .L1I//){L/J/m~-
Ann Louden
The University of Colorado Health Sciences Center is committed to equal opportunity and affirmative action
SH ELL-MCCLU RG-053827