Document 4QYGE7112KZ6bxb8a22Jx6pGR

A 1 2 3 4 5 6 7 8 Exhibit B as referred to in Benzene Consortium Write-Up 9 10 Item 11 AHSciences Case-Control Study 12 DP & ME Studies (UCHSC) 13 Irons(T & E) 14 Fudan University 15 16 Scientific Review Panel 17 Ethics Review Panel 18 External Pathology & Cytogenetics Workgroups(Cost in UC cost) 19 20 API Seed Monies 21 Outside Counsel 22 Public Affairs 23 QAJQC Activities 24 Misc. ? 25 26 27 28 GRAND TOTAL 29 Notes by API 30 Notes/Assumptions: 31 32 33 34 B CD Benzene - API Benzene Study Summary Exhibit B Overall Approved Budget Example only. To be verified by API Total Research Costs Total Panel Costs Miscellaneous Costs Subtotal API Overhead (5%) Approved Revised Cost Estimate (Dec. Original Cost Estimate (Jan. 2001) 2001) $1,595,000 $13,665,017 $1,253,428 $165,700 $16,679,145 $450,000 $500,000 $1,000,000 $190,855 $1,690,855 $18,820,000 $941,000 $19,761,000 $2,283,095 $15,258,017 $1,253,428 $190,555 $18,985,095 $648,000 $216,000 $130,000 $994,000 $0 $500,000 $1,000,000 $225,000 $0 $1,725,000 $21,704,095 $1,085,205 $22,789,300 - The total research costs have changed as a result of the protocol review process and changes in the protocols as - Panel costs assume that there will be only one face-to-face meeting for each panel each year. - Miscellaneous costs for outside counsel and media relations are based solely on assumptions. - QAJQC costs are based on an assumption of $45,000 per year for 5 years. Benzene Study Summary SH ELL-MCCLU RG-065948 E FG 1 2 3 4 5 6 7 8 9 Unapproved LChanges API not approved (June 10 2003) The attached tabs provide detail for AHS Costs 11 $2,283,(395 0 12 $15,258,000 (17) 13 $1,597,273 343,845 14 $661,000 470,445 15 $19,799,368 16 $551,736 (96,264) 17 $192,000 (24,000) 18 $0 (130,000) 19 $743,736 20 $0 0 21 $100,576 (399,424) 22 $960,600 (39,400) 23 $100,000 (125,000) 24 $0 0 25 $1,161,176 26 $21,704,280 27 $1,085,019 (186) 28 $22,789,299 (1) 29 30 31 32 33 34 Benzene Study Summary SH ELL-MCCLU RG-065949 A 1 2 B C D EF G H I Applied Health Sciences: Shanghai Health Study Budget Exhibit B J K 3 4 Year 5 6 2001 7 8 2002 9 10 2003 11 12 2004 13 14 2005 15 16 2006 17 18 2007 19 20 21 Total 22 23 24 25 26 Original Budget Jan. 2001 (w/o inflation adj. (Table 1) 84,025 326,175 288,900 266,400 290,125 305,175 34,200 Inflation Adjustment 5% annually (Table 2) 0 16,308 29,612 41,991 62,524 84,314 11,631 Original Budget WI Inflation 84,025 342,483 318,512 308,391 352,649 389,489 45,831 1,595,000 $ 246,380 $ 1,795,549 Additional Budget for Exposure Assessment (includes 5% inflation adj.) (Table 3) $0 $93,030 $113,999 $84,970 $89,218 $60,496 $0 $441,713 Approved Cost Total $84,025 $435,513 $432,511 $393,361 $441,867 $449,985 $45,831 AHS Payments to AHS Balance Date as of June 2003 128,852 435,406 120,508 $2,283,093 r Ties to total on previous page under Benzene Study Summary 684,766 $1,598,327 AHS Project Summary SH ELL-MCCLU RG-065950 A 1 2 3 Task 4 5 S(1ecific tasks 6 7 S1 8 S2 9 S3 10 S4 11 S5 12 S6 13 S7 14 S8 15 S9 16 S10 17 S11 18 S12 19 S13 20 S14 21 S15 22 S16 23 S17 24 25 General tasks 26 27 G1 28 G2 29 G3 30 G4 31 G5 32 33 Number of meetings and working tri(1s 34 35 36 37 38 39 40 41 42 (1-30-2002) Activity B CD E F Applied Health Sciences: TASK TIMELINE (Milestones) Exhibit B Project year Year 1 Year 2 Year 3 Year 4 G Year 5 H Year 6 Finalization of research protocol Development, translation and pre-test of questionnaire Development of database, data linkage and data security Enrollment of study subjects (AML & NHL patients and controls) Interviews of study subjects Acquisition of employment records of study subjects Data entry and data management Data audit Acquisition of exposure data from Shanghai CDC and factories Exposure assessment of individual study subjects Data analysis Presentation of results to Scientific Committee and sponsors in USA Presentation of results to SMU, Shanghai CDC & others in China Preparation of draft report Finalization of report and response to comments Preparation of manuscripts for journal publication Presentations of study at two international conferences X X X XX X XX XX X XX XX X XX XX X XX XX X XX X X XX X X XX X X X X X X X Working with Chinese investigators in Shanghai Meetings with the Scientific & Ethics Committees in USA Communication with the Scientific Committee Communication with the Ethics Committee Project management XX X XX XX X XX XX X XX XX X XX XX X XX Number of periodic meetings and working trips in Shanghai Number of periodic meetings in USA Meeting in USA to present study results Meeting in China to present study results Presentations at two international conferences 43 3 33 33 2 22 1 1 2 Milestones SHELL-MCCLURG-065951 A 1 Applied Health Sciences: 2 Labor for regular activities (time) 3 4 Category 5 Chief Epidemiologist (PI) 6 Biostatistician 7 Statistical programmer 8 Research assistant 9 Administrative assistant 10 Consulting industrial hygienist 11 Consulting hematologist 12 Consulting pathologist 13 Total labor for regular activities 14 15 16 Meetings/working tri(1s (time & eX(1enses) 17 18 19 Meetings in China (8 days @) 20 Meetings in USA (3 days @) 21 Meeting in Europe (4 days @) 22 Total for meetings/meeting trips 23 24 25 Other direct eX(1enses 26 27 28 Fee for IRB members 29 Domestic long-distance calls (in 2001 $) 30 International calls (in 2001 $) 31 Copying (in 2001 $) 32 Postage and express mail (in 2001 $) 33 Total for other expenses (in 2001 $) 34 35 36 GRAND TOTAL (in 2001 $) 37 38 39 TOTAL BUDGET FOR 6 YEARS (IN 2001 $) B C DE FG H 2001 Original Budget W/out Inflation Adjustment: Project year Hourly rate Year 1 Year 2 Year 3 in 2001 $ Hours Amount Hours Amount Hours Amount $280 $140 $120 380 $106,400 140 $19,600 120 $14,400 350 $98,000 120 $16,800 120 $14,400 300 120 120 $84,000 $16,800 $14,400 $90 100 $9,000 100 $9,000 100 $9,000 $90 80 $7,200 80 $7,200 80 $7,200 $200 120 $24,000 120 $24,000 100 $20,000 $250 20 $5,000 20 $5,000 20 $5,000 $250 20 $5,000 20 $5,000 20 $5,000 $190,600 $179,400 $161,400 Unit cost in 2001 $ $26,000 $12,000 $20,000 Year 1 No. Amount 4 $104,000 3 $36,000 $140,000 Year 2 No. Amount 3 $78,000 3 $36,000 $114,000 Year 3 No. Amount 3 $78,000 2 $24,000 $102,000 Year 1 Amount $2,500 $1,200 $1,000 $500 $300 $5,500 $336,100 Year 2 Amount $1,200 $1,000 $500 $300 $3,000 $296,400 Year 3 Amount $1,200 $1,000 $500 $300 $3,000 $266,400 I J K LM N Explanation of Costs - Exhibit B Year 4 Hours Amount 300 $84,000 120 $16,800 120 $14,400 100 $9,000 80 $7,200 100 $20,000 20 $5,000 20 $5,000 $161,400 Year 5 Hours Amount 400 $112,000 200 $28,000 200 $24,000 150 $13,500 120 $10,800 100 $20,000 20 $5,000 20 $5,000 $218,300 Year 6 Hours Amount 100 $28,000 20 $2,800 20 $1,800 $32,600 Year 4 No. Amount 3 $78,000 2 $24,000 $102,000 Year 5 No. Amount 4 $104,000 3 $36,000 $140,000 Year 6 No. Amount 1 $12,000 1 $20,000 $32,000 Year 4 Amount $1,200 $1,000 $500 $300 $3,000 $266,400 Year 5 Amount $1,200 $1,000 $500 $300 $3,000 $361,300 Year 6 Amount $1,500 $1,200 $800 $300 $3,800 $68,400 $1,595,000 Table1 SH ELL-MCCLU RG-065952 AI B I c I D I E I F 1 2001 Original Budget: With Inflation Adjustment - Exhibit B 2 Project year Total for project year Amount by quarter Calendar quarter Adjusted by 5% Total by calendar year 3 (in 2001 $) (in 2001 $) annual increase 4 5 Year 1 $336,100 $84,025 4th Q, 2001 $84,025 Total for 2001 - 6 $84,025 1st Q, 2002 $88,226 7 $84,025 2nd Q, 2002 $88,226 $348,704 8 $84,025 3rd Q, 2002 $88,226 $12,604 9 10 Year 2 $296,400 $74,100 4th Q, 2002 $77,805 Total for 2002 = 11 $74,100 1st Q, 2003 $81,695 12 $74,100 2nd Q, 2003 $81,695 $322,891 13 $74,100 3rd Q, 2003 $81,695 $26,491 14 15 Year 3 $266,400 $66,600 4th Q, 2003 $73,427 Total for 2003 = 16 $66,600 1st Q, 2004 $77,098 17 $66,600 2nd Q, 2004 $77,098 $304,720 18 $66,600 3rd Q, 2004 $77,098 $38,320 19 20 Year 4 $266,400 $66,600 4th Q, 2004 $77,098 Total for 2004 = 21 $66,600 1st Q, 2005 $80,953 22 $66,600 2nd Q, 2005 $80,953 $319,956 23 $66,600 3rd Q, 2005 $80,953 $53,556 24 25 Year 5 $361,300 $90,325 4th Q, 2005 $109,791 Total for 2005- 26 $90,325 1st Q, 2006 $115,280 27 $90,325 2nd Q, 2006 $115,280 $455,631 28 $90,325 3rd Q, 2006 $115,280 $94,331 29 30 Year 6 $68,400 $34,200 4th Q, 2006 $43,649 Total for 2006 = 31 $34,200 1st Q, 2007 $45,831 Total for 2007 = 32 $89,480 33 $21,080 34 Total $1,595,000 $246,382 $1,841,382 $246,382 G $84,025 $342,484 $318,512 $308,391 $352,649 $389,489 $45,831 Table 2 SH ELL-MCCLU RG-065953 A BC D E F G H I J K L 1 Scientific Review Panel Budget Increase by Category: With Inflation Adjustment Exhibit B 2 Labor b~ categor~ 3 Hourly rate Year 1 Year 2 Year 3 Year 4 Year 5 4 Category 5 Chief Epidemiologist (PI) in 2001 $ Hours $280 80 Amount Hours $22,400 40 Amount Hours $11,200 40 Amount Hours $11,200 40 Amount Hours $11,200 40 Amount $11,200 6 Statistical programmer $120 20 $2,400 20 $2,400 20 $2,400 20 $2,400 20 $2,400 7 Research assistant 8 Consulting industrial hygienist $90 $200 20 120 $1,800 $24,000 20 120 $1,800 $24,000 20 100 $1,800 $20,000 20 100 $1,800 $20,000 20 100 $1,800 $20,000 9 Total labor for regular activities (2001 $) 10 $50,600 $39,400 $35,400 $35,400 $35,400 11 12 Meetings/working tri[!s (time & ex[!enses) 13 Unit cost Year 1 Year 2 Year 3 Year 4 Year 5 14 in 2001 $ No. Amount No. Amount No. Amount No. Amount No. Amount 15 Meetings in China (8 days @) 16 Meetings in USA (3 days @) $26,000 $12,000 1 $26,000 1 $12,000 2 $52,000 1 $12,000 1 $26,000 1 $12,000 1 $26,000 1 $12,000 1 $12,000 17 Total for meetings/working trips (2001 $) 18 19 Total in 2001 $ (labor and trips) 20 $38,000 $88,600 $64,000 $103,400 $38,000 $73,400 $38,000 $73,400 $12,000 $47,400 21 22 23 Yearl~ budget estimates with a 5% annual adjustment 24 4,430 10,599 11,570 15,818 13,096 25 Budget by calendar year 26 Total (with 5% annual adjustment) Year 2002 $93,030 Year 2003 $113,999 Year 2004 $84,970 Year 2005 $89,218 Year 2006 $60,496 M Hours 240 100 100 540 $980 No. 5 5 10 Table 3 SH ELL-MCCLU RG-065954 N 1 2 3 otal 4 Amount 5 $67,200 6 $12,000 7 $9,000 8 $108,000 9 $196,200 10 11 12 13 otal 14 Amount 15 $130,000 16 $60,000 17 $190,000 18 19 $386,200 20 21 22 23 24 55,512 25 Total 26 $441,712 Table 3 SH ELL-MCCLU RG-065955 A 1 B C DI E I F I G I H 2 Benzene-API Executive Summary 3 Benzene Consortium Study Executive Summary (Exhit 4 March 31, 2003 April 1, 2003 April 2, 2003 5 Income 4,526,337 6 BP 2,956,951 7 Chevron Texaco 1,971,300 8 Conoco Phillips 985,651 9 Exxon Mobil 2,956,951 10 Shell 1,971,300 11 Marathon 15,000 12 Additional Income 112,008 13 Total Income $10,969,161 14 15 Expenses 16 UCHSC(inciudes Ext. Path and Cyn) 7,515,750 17 Irons Field Expenses 539,486 18 Applied Health Sciences 684,766 19 Fudan University 21,711 20 Scientific Review Panel 30,970 21 Ethics Review Panel 2,500 22 Communications - APCO 254,907 23 Outside Legal Counsel 14,804 24 QAJQC Support 25 API Administrative And Overhead 0 345,119 26 Total Expenses $9,410,013 27 Balance at API 28 Project overage as of March 2003 is $1,559,148 $1,559,148 29 30 Based on current projected income and expenses to date per API 31 Balance 3/03 Income Expenses Balance YTD 32 Dec-03 1,559,148 5,642,847 (3,547,718) 3,654,277 33 Dec-04 (4,126,155) (4,126,155) 34 Dec-05 (4,126,582) (4,126,582) 35 Dec-06 (1,578,831) (1,578,831) 36 Total (Shortfall)/Overage (13,379,286) ($6,177 ,291) 37 Note: Above information should be verified by API. If expenses continue and no further contributions are made after 2003, as projected by API, a shortfall of ($471 ,878) will result by the end of 2 Projected 38 39 UCHSC(inciudes Ext. Path and Cyn) Project Items Actual 7,515,750 Expenses 7,742,250 40 Irons Field Expenses 41 Applied Health Sciences 42 Fudan University 43 Scientific Review Panel 44 Ethics Review Panel 539,486 684,766 21,711 30,970 2,500 1,057,787 1,598,329 639,289 520,766 189,500 45 Communications - APCO 46 Outside Legal Counsel 47 QAJQC Support 48 API Administrative And Overhead 254,907 14,804 0 345,119 705,693 85,772 100,000 739,900 49 Total 9,410,013 13,379,286 50 51 &[FILE] SH ELL-MCCLU RG-065956 I IJ IK 1 2 3 it A) 4 2004 2005 2006 5 6 7 8 9 10 11 12 13 $0 $0 $0 14 15 16 17 18 19 20 21 22 23 24 25 26 $0 $0 $0 27 $0 $0 $0 28 29 30 31 Shortfall By Yr 32 33 (471,878) 34 (4,598,460) 35 (1,106,953) 36 (6,177,291) 37 )04, ($4,598,460) by L 2007 $0 $0 $0 38 Balance 39 15,258,000 40 1,597,273 41 2,283,095 42 661,000 43 551,736 44 192,000 45 960,600 46 100,576 47 100,000 48 1,085,019 49 22,789,299 50 51 &[FILE] SH ELL-MCCLU RG-065957 Benzene Health Research Consortium Overview of Financial Process Controls Administration July 9,2003 American Petroleum Institute Attn: Lorraine Twerdok Manager Health Sciences (BHRC Administrator) 1220 L Street, Northwest Washington, D.C. 20005-4070 Dear Ms. Twerdok: SUBJECT: FINANCIAL PROCESS COMPLIANCE AUDIT A one day audit was performed on behalf of the Benzene Health Research Consortium (BHRC) at API offices located in Washington, D.C. on Wednesday, July 2,2003. The objective of the audit was to verify financial process compliance as well as review and gain additional confidence surrounding financial tracking of various studies included in the Benzene Consortium Study. I would like to express my thanks to you, Bruce Jamot - Senior Toxicologist, Matt ToddCommunications and Paula Podhasky, Subscription Research Program Coordinator and the rest of the API staff for the courtesy and cooperation received during the review. AUDIT SCOPE: Customers: Benzene Health Research Consortium Companies Budget Period Covered: December 2001 - January 2007 Site Visited: API Office, Washington, D. C. For purposes of this report, the study is comprised of the following projects based on approved budget items provided by API on July 2, 2003: University of Colorado Health Sciences Center (UCHSC) 15,258,000 Richard Irons - Field Study Expenses Applied Health Sciences Fudan University Scientific Review Panel Ethics Review Panel Communications - APCO Outside Legal Counsel QAlQC Support API Administrative Overhead Total Approved Budget Amount 1,597,273 2,283,095 661,000 551,736 192,000 960,600 100,576 100,000 1,085,019 $22,789,299 SH ELL-MCCLU RG-065958