2019-07-29T14:12:01-05:00 2018-12-31 BDO USA LLP 8401 GREENSBORO DRIVE 800 MCLEAN VA 22102 990 2018-01-01 311621592 INTERNATIONAL VACCINE INSTITUTE % EUNHYE LEE INTE 8228722803 snu research park 1 gwanak-ro seoul KS 151-742 FRANCOIS BELIN DEP DIR GENERAL, COO 7038930600 2019-07-29 true Jacob Cook P01240455 7038930600 4.15.233.162 54621820192105000000 2019-07-29 P C44969C09172B32DC5279494C6AE8494327A5917 21113678E977CF0F147E11547FB84355093581B2 2018 2019-02-21 02:37:17Z JEROME H KIM SNU RESEARCH PARK 1 GWANAK-RO SEOUL KS 151-742 30267343 false X www.ivi.int X 1997 SEE SCHEDULE O 14 13 1 14 0 27484411 29608736 0 0 76238 185544 235868 472531 27796517 30266811 7865415 8993323 0 0 10302629 10893841 0 0 425286 7774133 8698909 25942177 28586073 1854340 1680738 20916339 21208830 14043688 12798045 6872651 8410785 X SEE SCHEDULE O true true 3065176 1952925 MERS-COV VACCINE DEVELOPMENT AGAINST MERS-COV SINCE IVI LAUNCHED THE MERS PROGRAM IN LATE 2015 WITH FUNDING FROM THE SAMSUNG LIFE PUBLIC WELFARE FOUNDATION, IVI CONTINUES TO WORK ON ACCELERATING THE DEVELOPMENT OF MERS VACCINES, WITH THE AIM OF DEMONSTRATING THE SAFETY AND IMMUNOGENICITY OF TWO MERS VACCINES IN PHASE II TRIALS CONDUCTED IN SOUTH KOREA. WITH IND APPROVAL BY THE KOREAN OF FOOD AND DRUG STFETY (KEFDS) IN 2017, IVI AND AND GENEONE LIFE SCIENCES CONTINUED COLLABORATION ON CONDUCTING THE PHASE I/IIA CLINICAL TRIALS OF GENEONE'S MERS DNA VACCINE CANDIDATE IN LATE 2018. UPON COMPLETION OF THE NEW TOXICITY STUDY,REQUIRED BY KMFDS AS PART OF THEIR IND APPROVAL,THE TRIAL INITIATED IN SEPTEMBER 2018, TARGETING COMPLETION OF SUBJECT ENROLLMENT BY JANUARY 2019. IVI ALSO KEPT ENGAGING WITH A DONOR AND VACCINE DEVELOPERS TO SELECT 2ND CANDIDATE MERS-COV VACCINE IN ADDITION TO GENEONE DNA VACCINE, THROUGH LANDSCAPE ANALYSIS. IN 2018, IVI WAS ACTIVELY INVOLVED IN AND LED DISCUSSION FOR COLLABORATION WITH POTENTIAL MANUFACTURING PARTNERS SUCH AS US-BASED NOVAVAX, UK-BASED VACCITECH AND KOREA-BASED SL VAXIGEN. OTHER THAN CLINICAL STUDIES, AN EPIDEMIOLOGICAL STUDY TO DEVELOP AND ANALYZE A DYNAMIC MODEL OF MERS-COV TRANSMISSION IN KOREA COMPLETEDIN DECEMBER 2018, WHICH WOULD SUPPORT THE KOREAN REGULATORY BODIES TO MAKE EFFECTIVE STRATEGIES ON MERS-COV VACCINATION AND VACCINE STOCKPILING. IVI HAS ALSO RENEWED THE PERIODIC PERMISSION FOR OPERATING BSL-3 FACILITIES FROM THE KOREA GOVERNMENT IN OCTOBER 2018, AND AFTER OBTAINING THE REGULATORY APPROVAL FOR HANDLING HIGH RISK PATHOGENS, IT HAS STORED WILD TYPE MERS-COV AND WOULD BE OPERATED FOR LABORATORY TESTING ON MERS-COV CLINICAL SAMPLES. 2780913 1205369 SETA SEVERE TYPHOID IN AFRICA(SETA) SETA IS A FOLLOW-UP GRANT OF TSAP FUNDED BY THE BILL AND MELINDA GATES FOUNDATION. IT AIMS TO ESTIMATE THE BURDEN, SEVERITY, IMMUNE RESPONSE, LONG-TERM SEQUELAE AND THE ASSOCIATED COSTS OF INVASIVE SALMONELLA INFECTIONS IN SUB-SAHARAN AFRICA. NETWORK OF SURVEILLANCE SITES ACROSS 6 COUNTRIES IN SSA IS SET UP AND ACTIVITIES ARE ON-GOING IN ALL SETA COUNTRIES: MADAGASCAR (ANTANANARIVO, IMERINTSIATOSIKA), BURKINA FASO (OUAGADOUGOU, POLESGO, NIOKO), GHANA (AGOGO, KUMASI), NIGERIA (IBADAN), ETHIOPIA (ADAMA WENJI AND WELAYITA SODO), AND DRC (KISANTU.) AS OF DECEMBER 31, 2018, A TOTAL OF 318,076 PATIENTS HAD BEEN SCREENED FROM ALL PARTICIPATING SITES. FROM THESE SCREENED PATIENTS,12.5% (39,736/318,076) MET THE STUDY INCLUSION CRITERIA OF WHICH 40.6% (16,134/39,736) WERE ENROLLED IN SETA 2392980 901746 Vi-DT clinical developmnet support for SK VI-DT CLINICAL DEVELOPMENT SUPPORT FOR SK CHEMICALS WE DEVELOPED A TYPHOID CONJUGATE VACCINE USING PLATFORM TECHNOLOGY FROM THE U.S. NATIONAL INSTITUTES OF HEALTH, CONJUGATING THE SALMONELLA TYPHI VI POLYSACCHARIDE TO DIPHTHERIA TOXOID (VI-DT). CONJUGATE VACCINES HAVE THE ADVANTAGE OF CONFERRING PROTECTION TO INFANTS (A HIGH-RISK GROUP) AGAINST TYPHOID AS WELL AS GENERATING T-CELL-BASED IMMUNE RESPONSES. IVI TRANSFERRED THIS TECHNOLOGY TO SK CHEMICALS IN SOUTH KOREA IN 2013 AND RECEIVED GRANTS FROM THE GATES FOUNDATION TO WORK WITH SK CHEMICALS (IVI IS LEADING CLINICAL DEVELOPMENT). THIS COLLABORATION AIMS TO OBTAIN VACCINE LICENSURE AND THEN RECEIVE WHO PREQUALIFICATION FOR PROCUREMENT IN THE GAVI/ UNICEF MARKET. - PHASE I CLINICAL TRIAL FOR SK VI-DT WAS COMPLETED IN MANILA, THE PHILIPPINES. THERE WERE 144 STUDY PARTICIPANTS ENROLLED. THE TRIAL SHOWED NO VACCINE SAFETY CONCERNS AND A 100% SEROCONVERSION RATE. - PHASE II CLINICAL TRIALS IS IN PROGRESS IN THE PHILIPPINES WITH TOTAL 285 STUDY PARTICIPANTS ENROLLED. - PREPARATORY ACTIVITIES ARE BEING CONDUCTED FOR PHASE III CLINICAL TRIALS IN NEPAL AND THE PHILIPPINES. 15000599 4933282 23239668 true true false false false false false false false false true false false false true false true false false true true true false false false false false true false true false false false true false false false false true false false false false false false false false true X 0 0 1 true false true KS false false false false false false false false X 14 13 false false false false false true false true true false false false true true true true true true true false X EUNHYE LEE 8228722803 snu research park 1 gwanak-ro gwanak-gu, seoul KS 151-742 George Bickerstaff Chairman / Board of Trustee 1.0 0.0 X 1592 0 0 George Siber Director / Board of Trustee 1.0 0.0 X 2092 0 0 Joseph Kim Director / Board of Trustee 1.0 0.0 X 1500 0 0 Hanna Nohynek Director / Board of Trustee 1.0 0.0 X 1592 0 0 Fred Binka Director / Board of Trustee 1.0 0.0 X 1684 0 0 Malcolm Sweeney Director / Board of Trustee 1.0 0.0 X 1684 0 0 Jerome Kim Director General 40.0 0.0 X X 618648 0 153414 Ralf Clemens Director / Board of Trustee 1.0 0.0 X 1842 0 0 Takashima Yoshihiro Director / Board of Trustee 1.0 0.0 X 1296 0 0 Lee Kyu Hyung Director / Board of Trustee 1.0 0.0 X 750 0 0 Chris Varma DIRECTOR / BOARD OF TRUSTEE 1.0 0.0 X 0 0 0 Shin Young Soo DIRECTOR / BOARD OF TRUSTEE 1.0 0.0 X 0 0 0 Kweon Ki-hwan DIRECTOR / BOARD OF TRUSTEE 1.0 0.0 X 0 0 0 Jee Youngmee DIRECTOR / BOARD OF TRUSTEE 1.0 0.0 X 0 0 0 Ros-Mari Balow DIRECTOR / BOARD OF TRUSTEE 1.0 0.0 X 0 0 0 Balram Bhargava DIRECTOR / BOARD OF TRUSTEE 1.0 0.0 X 0 0 0 Phil Driver Deputy Dir. Gen of Fin & Ops 40.0 0.0 X 338472 0 2811 Julia Lynch Deputy Dir. Gen of Dev & delvy 40.0 0.0 X 416845 0 87433 Sushant Sahastrabuddhe Program Director, Typhoid 40.0 0.0 X 200002 0 4902 Viliam Pavliak Head of Vaccine Process Dev 40.0 0.0 X 250047 0 67860 Yun Chon Head of Biostatistics & Data 40.0 0.0 X 223113 0 53654 Kyung-Taik Han Deputy Dir. Gen of Gov Affairs 40.0 0.0 X 218773 0 1217 Tobin Guarnacci Head of Quality Management 40.0 0.0 X 190239 0 42056 2470171 0 413347 33 false true false The Boston Consulting Group Inc PO box 75200 CHICAGO IL 606755200 CONSULTING 490011 1 12424 7146738 22449574 26338 29608736 0 185544 185544 0 0 0 0 0 0 0 12424 532 -532 -532 0 0 0 0 0 0 MISCELLANEOUS REVENUE 900099 131763 131763 RENTAL FOR ANIMAL ROOM 900099 25192 25192 RENTAL FOR RESEARCH COLLABORATION 900099 316108 316108 473063 30266811 658075 712234 712234 0 8281089 8281089 0 5023172 2283403 2639767 100002 0 4819036 3393960 1280137 144939 604200 381872 202524 19804 292738 151487 135554 5697 154695 95128 54188 5379 0 144869 46699 98170 0 70597 14938 55659 0 0 0 0 1938617 1417442 409472 111703 0 406892 312773 84114 10005 614726 530633 80038 4055 0 1578828 44318 1534510 0 1608892 1282312 324939 1641 0 358648 280502 60467 17679 0 0 243262 0 243262 0 56093 14075 41134 884 LAB SUPPLIES 1553547 1531419 22128 REPAIRS AND MAINTENANCE 63762 11560 52202 TRAINING 15647 7577 8070 ALLOCATION OF INDIRECT COSTS 2435098 -2435098 44529 11149 29882 3498 28586073 23239668 4921119 425286 0 0 19061316 18458926 81190 443355 24709 50718 140545 33994 0 0 102974 0 0 0 229986 271305 7992082 6334826 1271373 1657256 0 0 0 0 0 0 0 0 4246 293276 20916339 21208830 1469522 1508413 0 0 11557615 10576991 0 0 0 0 0 0 0 0 0 0 1016551 712641 14043688 12798045 X 4160489 5698623 2712162 2712162 0 0 6872651 8410785 20916339 21208830 X 1680738 -142604 X false true X true false X 23508996 21104491 25948268 27484411 29608736 127654902 0 0 23508996 21104491 25948268 27484411 29608736 127654902 51727093 75927809 72912 35005 49021 76238 185544 418720 0 28581 15859 63086 235735 473063 816324 128889946 7075 0.58909 0.58478 X 7948718 6326876 1621842 43364 7950 35414 1657256 0 ADVANCE FUND FROM SIDA 522400 SECURITY DEPOSIT 190241 712641 30267343 30267343 -532 -532 30266811 28586605 532 532 28586073 28586073 Part XI, Line 4B: Cost of Goods Sold -$532 Part XII, Line 2D: Cost of Goods Sold $532 true East Asia and the Pacific 1 131 Program Services Program Service 6768510 Europe (Including Iceland and Greenland) Grantmaking 739223 South Asia Grantmaking 4375 Sub-Saharan Africa Grantmaking 768982 1 131 1 131 8281090 8281090 East Asia and the Pacific Program Service 1952925 WIRE East Asia and the Pacific Program service 1558350 WIRE East Asia and the Pacific Program service 637271 WIRE East Asia and the Pacific Program service 540966 WIRE East Asia and the Pacific Program service 470882 WIRE East Asia and the Pacific Program service 343290 WIRE Europe (Including Iceland and Greenland) Program service 324464 WIRE East Asia and the Pacific Program service 269752 WIRE East Asia and the Pacific Program service 253318 WIRE East Asia and the Pacific Program service 247700 WIRE East Asia and the Pacific Program service 241480 WIRE Europe (Including Iceland and Greenland) Program service 172766 WIRE Sub-Saharan Africa Program service 169112 WIRE Sub-Saharan Africa Program service 142027 WIRE Sub-Saharan Africa Program service 137574 WIRE Europe (Including Iceland and Greenland) Program service 132043 WIRE Sub-Saharan Africa Program service 110288 WIRE Europe (Including Iceland and Greenland) Program service 109708 WIRE Sub-Saharan Africa Program service 80000 WIRE Sub-Saharan Africa Program service 73101 WIRE East Asia and the Pacific Program service 70000 WIRE East Asia and the Pacific Program service 44000 WIRE Sub-Saharan Africa Program service 36940 WIRE East Asia and the Pacific Program service 30000 WIRE East Asia and the Pacific Program service 28113 WIRE East Asia and the Pacific Program service 22559 WIRE East Asia and the Pacific Program service 21433 WIRE East Asia and the Pacific Program service 15937 WIRE East Asia and the Pacific Program service 9690 WIRE Sub-Saharan Africa Program service 8544 WIRE Sub-Saharan Africa Program service 8050 WIRE 31 false false false false false false MONITORING GRANTS OUTSIDE THE US THE IVI IS LOCATED IN SEOUL, KOREA WHERE ALL THE GRANT FUNDS ARE MANAGED AND EXECUTED. THE IVI HAS IN PLACE A VERY DETAILED AND RIGOROUS SYSTEM OF FINANCIAL MONITORING. THIS SYSTEM, WHICH IS EVALUATED BY INTERNAL FINANCE PERSONNEL THROUGHOUT THE YEAR AND AUDITED EXTERNALLY EVERY YEAR, IS USED IN CONJUNCTION WITH CAREFUL PROJECT DEVELOPMENT AND IMPLEMENTATION TO ENSURE ACCOUNTABILITY AND BUDGETARY MANAGEMENT RESPONSIBILITY. FOR SUBGRANTS, THE IVI HAS A BROAD OVERALL SYSTEM OF REVIEWING AND TRACKING THE USE OF GRANTS, AND MORE SPECIFIC DAY-To-DAY REVIEW PROCESSES, WHICH INCLUDE THE FOLLOWING: -REVIEWS OF FINANCIAL AND NARRATIVE REPORTS, AUDIT REPORTS, CORRESPONDENCE AND OTHER DOCUMENTATION PROVIDED BY THE GRANTEES -DIRECT COMMUNICATION WITH GRANTEES THROUGH TELEPHONE AND EMAIL FOR QUESTIONS AND TO CHECK ON PROGRESS OF THE PROJECT -ON-SITE VISITS TO THE FIELD SITES TO REVIEW ONE OR MORE ASPECTS OF THE PROJECTS -MONITORING THROUGH AN EXTERNAL AUDIT. A CERTAIN NUMBER OF SUB-GRANTEES ARE SELECTED FOR THE AUDIT EACH YEAR, WHICH IS DONE TO ENSURE FINANCIAL AND EXPENDITURE COMPLIANCE WITH THE RESEARCH AGREEMENT. true Child Health Research Foundation 1 N LEXINGTON AVE WHITE PLAINS NY 10601 272415391 501(c)(3) 66482 Program service INC Research LLC 3201 BEECHLEAF CT STE 600 RALEIGH NC 27604 330723120 178532 PROGRAM SERVICE Innovations for Global Health 3240 HURON PEAK AVE SUPERIOR CO 80027 201059464 501(C)(3) 141150 PROGRAM SERVICE MPI Research Inc 54943 N MAIN STREET MATTAWAN MI 49071 383400587 326070 PROGRAM SERVICE 2 2 MONITORING USE OF GRANTS THE IVI IS LOCATED IN SEOUL, KOREA WHERE ALL THE GRANT FUNDS ARE MANAGED AND EXECUTED. THE IVI HAS IN PLACE A VERY DETAILED AND RIGOROUS SYSTEM OF FINANCIAL MONITORING. THIS SYSTEM, WHICH IS EVALUATED BY INTERNAL FINANCE PERSONNEL THROUGHOUT THE YEAR AND AUDITED EXTERNALLY EVERY YEAR, IS USED IN CONJUNCTION WITH CAREFUL PROJECT DEVELOPMENT AND IMPLEMENTATION TO ENSURE ACCOUNTABILITY AND BUDGETARY MANAGEMENT RESPONSIBILITY. FOR SUBGRANTS, THE IVI HAS A BROAD OVERALL SYSTEM OF REVIEWING AND TRACKING THE USE OF GRANTS, AND MORE SPECIFIC DAY-To-DAY REVIEW PROCESSES, WHICH INCLUDE THE FOLLOWING: -REVIEWS OF FINANCIAL AND NARRATIVE REPORTS, AUDIT REPORTS, CORRESPONDENCE AND OTHER DOCUMENTATION PROVIDED BY THE GRANTEES -DIRECT COMMUNICATION WITH GRANTEES THROUGH TELEPHONE AND EMAIL FOR QUESTIONS AND TO CHECK ON PROGRESS OF THE PROJECT -ON-SITE VISITS TO THE FIELD SITES TO REVIEW ONE OR MORE ASPECTS OF THE PROJECTS -MONITORING THROUGH AN EXTERNAL AUDIT. A CERTAIN NUMBER OF SUB-GRANTEES ARE SELECTED FOR THE AUDIT EACH YEAR, WHICH IS DONE TO ENSURE FINANCIAL AND EXPENDITURE COMPLIANCE WITH THE RESEARCH AGREEMENT. X X X X true true X X X X false false false false false false false false false Jerome Kim Director General 311278 0 28987 0 278383 0 142092 0 11322 0 772062 0 0 0 Julia Lynch Deputy Dir. Gen of Dev & delvy 225390 0 0 0 191455 0 82947 0 4486 0 504278 0 0 0 Phil Driver Deputy Dir. Gen of Fin & Ops 258005 0 0 0 80467 0 0 0 2811 0 341283 0 0 0 Sushant Sahastrabuddhe Program Director, Typhoid 112324 0 0 0 87678 0 0 0 4902 0 204904 0 0 0 Viliam Pavliak Head of Vaccine Process Dev 176868 0 0 0 73179 0 65470 0 2390 0 317907 0 0 0 Yun Chon Head of Biostatistics & Data 147220 0 0 0 75893 0 52437 0 1217 0 276767 0 0 0 Kyung-Taik Han Deputy Dir. Gen of Gov Affairs 187765 0 0 0 31008 0 0 0 1217 0 219990 0 0 0 Tobin Guarnacci Head of Quality Management 120000 0 0 0 70239 0 31625 0 10431 0 232295 0 0 0 COMPENSATION TRAVEL FOR COMPANION: AFTER 15 MONTHS OF SERVICE, THE INTERNATIONALLY RECRUITED STAFF IS ENTITLED TO HOME LEAVE TRAVEL. THIS ENTITLEMENT IS AN ECONOMY ROUND TRIP BETWEEN DUTY STATION AND HOME BASE FOR STAFF, SPOUSE AND DEPENDENTS UNDER 21. TAX INDEMNIFICATION AND GROSS UP PAYMENTS: IN ORDER TO EQUALIZE THE BENEFITS ACCRUED TO INTERNATIONALLY RECRUITED STAFF, IVI COMPENSATES STAFF WHO ARE OBLIGATED TO PAY TAXES ON IVI DERIVED INCOME TO THEIR HOME COUNTRY. ANY TAX SUBSEQUENTLY LEVIED ON THE AMOUNT OF THE REIMBURSEMENT IS NOT REIMBURSED. IN GENERAL, THIS IS TREATED AS TAXABLE COMPENSATION. HOUSING ALLOWANCE: IVI PROVIDES INTERNATIONALLY RECRUITED STAFF IN KOREA WITH A HOUSING ALLOWANCE UP TO 75% OF A CEILING THAT IS ESTABLISHED AND REVIEWED PERIODICALLY. PERSONAL SERVICES (I.E. DRIVER): IVI PROVIDES THE DIRECTOR GENERAL WITH A DRIVER WHICH IS INCLUDED IN HIS/HER EMPLOYMENT CONTRACT PACKAGE APPROVED BY THE BOARD OF TRUSTEES. JEROME KIM EMPLOYEE EDUCATION X 16964 11309 false true true TOBIN GUANACCI EMPLOYEE EDUCATION X 12745 8497 false true true ARIJIT SIL EMPLOYEE EDUCATION X 10583 4209 false true true SATYANARAYANA BEJJANI EMPLOYEE EDUCATION X 18363 6907 false true true ANH WARTEL EMPLOYEE EDUCATION X 4743 3072 false true true 33994 X ROK EQUIPMENT 1 26338 FMV false true false PART I, LINE 25, COLUMN (B): THE ORGANIZATION REPORTS THE NUMBER OF CONTRIBUTIONS RECEIVED. FORM 990, PART I, LINE 1: IVI'S MISSION IS TO DISCOVER, DEVELOP AND DELIVER SAFE, EFFECTIVE AND AFFORDABLE VACCINES FOR THE WORLD'S DEVELOPING NATIONS. ITS VISION IS DEVELOPING COUNTRIES FREE OF SUFFERING FROM INFECTIOUS DISEASE. FORM 990, PART III, LINE 1: IVI IS THE ONLY INTERNATIONAL ORGANIZATION IN THE WORLD EXCLUSIVELY DEDICATED TO DISCOVERING, DEVELOPING AND DELIVERING VACCINES FOR GLOBAL HEALTH. IVI FOCUSES ON VACCINES AGAINST INFECTIOUS DISEASES OF THE MOST IMPOVERISHED. WE AIM TO MAKE VACCINES AVAILABLE AND ACCESSIBLE FOR VULNERABLE POPULATIONS IN DEVELOPING COUNTRIES. WE LIVE IN AN INCREASINGLY GLOBALIZED WORLD WHERE NEW AND EMERGING INFECTIOUS DISEASES CAN BECOME GLOBAL HEALTH THREATS. IVI ALSO FOCUSES ON VACCINES AGAINST INFECTIOUS DISEASES OF MAJOR GLOBAL HEALTH CONCERN. OUR RESEARCH SPANS THE ENTIRE VACCINE SPECTRUM FROM DISCOVERY AND PRECLINICAL DEVELOPMENT IN OUR SEOUL-BASED LABS TO CLINICAL DEVELOPMENT AT FIELD SITES IN DEVELOPING COUNTRIES TO GENERATING SCIENTIFIC EVIDENCE ON THE NEED FOR VACCINATION IN COUNTRIES WHERE VACCINES ARE MOST NEEDED. OUR HEADQUARTERS IN SEOUL HAVE STATE-OF-THE ART LAB FACILITIES, ANIMAL HOUSE, AND RESEARCH TEAMS THAT INCLUDE CLINICAL IMMUNOLOGY, PROCESS DEVELOPMENT, EPIDEMIOLOGY, CLINICAL & REGULATORY, BIOSTATISTICS & DATA MANAGEMENT, AND POLICY & ECONOMIC RESEARCH. OUTSIDE OF SEOUL, WE HAVE A GLOBAL NETWORK OF FIELD SITES IN MORE THAN 20 COUNTRIES IN ASIA, AFRICA, AND THE AMERICAS. WE MANAGE FIELD SITES IN COLLABORATION WITH REGIONAL AND IN-COUNTRY PARTNERS. WE WORK WITH LOCAL PARTNERS TO IMPLEMENT TRANSLATIONAL AND FIELD RESEARCH PROJECTS, AND WE ALSO PROVIDE TRAINING AND TECHNICAL ASSISTANCE. FORM 990, PART III, LINE 2: THAILAND HPV VACCINE SINGLE DOSE IMPACT STUDY. A NEW GRANT HAS BEEN AWARDED (APRIL 2018) BY BMGF (USD 6,465,515) OVER THE 66-MONTH PERIOD TO CONDUCT AN EFFECTIVENESS STUDY COMPARING THE IMPACT OF THE WHO RECOMMENDED TWO DOSE REGIMEN OF HPV VACCINE TO A SINGLE DOSE REGIMEN IN TWO PROVINCES IN THAILAND OVER THE 66-MONTH PERIOD. FOLLOWING AWARD OF THE GRANT, A KICK-OFF MEETING WAS HELD IN BANGKOK ON APRIL 18-19, 2018 TO BRING ALL COLLABORATORS (THE THAI MINISTRY OF PUBLIC HEALTH, DEPARTMENT OF DISEASE CONTROL, CHULALONGKORN UNIVERSITY IN BANGKOK, AND THE US-CDC) TOGETHER TO ALIGN ON THE PROJECT PLAN AND TIMELINE AND ESTABLISH WORKING GROUPS TO ADVANCE THE STUDY PLANS AND PROTOCOL. A STUDY STEERING COMMITTEE (SSC) WAS FORMED AMONG THE SENIOR SCIENTISTS FROM THE COLLABORATING ORGANIZATIONS IN ORDER TO ENSURE AN EFFECTIVE MECHANISM FOR COMMUNICATION, RISK MANAGEMENT AND ISSUE RESOLUTION AMONG THE PARTNERS. THROUGHOUT THE SUMMER AND FALL OF 2018 THE WORK PLAN DEVELOPMENT OF THE DIFFERENT WORKING GROUPS WAS INTEGRATED INTO CLINICAL PROTOCOLS AND FINAL WORK PLANS. PREPARATORY ACTIVITIES ALSO OCCURRED IN PARALLEL AT THE CHULALONGKORN LABORATORY INCLUDING REMODELING AND EQUIPPING OF A NEW DEDICATED LAB SPACE FOR COBAS TESTING, TRAINING OF LABORATORY STAFF, ENHANCEMENT OF THE QUALITY SYSTEM, AND COMPLETION OF A TEST METHOD EVALUATION. THE CHULALONGKORN LABORATORY FURTHER UNDERWENT AN AUDIT BY THE IVI QUALITY ASSURANCE UNIT (DECEMBER 2018) PRIOR TO INITIATION OF SAMPLE TESTING. PROTOCOL APPROVALS WERE FINALLY RECEIVED FROM THAILAND MOPH EC (NOVEMBER 29, 2018), CHULALONGKORN UNIVERSITY IRB (DECEMBER 4, 2018) AND THE IVI IRB (DECEMBER 13, 2018) THUS COMPLETING STUDY PREPARATORY ACTIVITIES ON DECEMBER 13, 2018. ENROLLMENT OF SUBJECTS WAS INITIATED ON DECEMBER 17, 2018, ALL VACCINATIONS (N=15,818) AND ALL BASELINE SURVEY ENROLLMENTS INCLUSIVE OF A URINE SPECIMEN (N= 8,588) WERE COMPLETED BY MARCH 4, 2019. FORM 990, PART III, LINE 3: SHANCHOL, ORAL cholera VACCINE MODIFIED AND TECHNOLOGY-TRANSFERRED BY IVI IN 2008, WAS LICENSED IN INDIA IN 2009. POST LICENSURE, SEVERAL QUESTIONS REMAINED TO BE ANSWERED CRITICAL FOR VACCINE DEVELOPMENT. IVI PROPOSED A SERIES OF STUDIES THAT WOULD EXPAND THE EVIDENCE-BASED CRITICAL INFORMATION FOR USE OF OPTIMAL DOSING REGIMEN. THE GRANT WITH FOUR OBJECTIVES WAS AWARDED BY THE FOUNDATION IN OCTOBER 2009 AND CONTINUED UNTIL DECEMBER 2017. INITIAL APPROVED GRANT WAS $7,507,377 FOR 47 MONTHS FROM AUGUST 2013. IN 2012, THE BUDGET FOR SINGLE DOSE INCREASED DRASTICALLY DUE TO AN INCREASE OF SAMPLE SIZE (FROM -85,000 TO -155,000) OF THE STUDY. THEREFORE, WE REQUESTED TO TRANSFER THE BALANCE FUND OF PHASE III EXT. GRANT (1005560), CHOVI GRANT (38590) AND CHOZAN GRANT (760606) TO THE SINGLE DOSE TRIAL. THE MASTER AMENDMENT DATED JANUARY 24, 2014 ALLOWED THIS TRANSFER. CONSEQUENTLY, TOTAL GRANT AMOUNT HAS BEEN INCREASED FROM $7,507,377 TO $14,121,679. IN YEAR 7, WITH PERIOD EXTENSION, WE RECEIVED THE SUPPLEMENTAL FUNDING ($309,260) TO COVER REVACCINATION. INCLUDING THIS SUPPLEMENT FUNDING, THE TOTAL GRANT INCREASED TO $13,430,939. THROUGH THE ENTIRE GRANT PERIOD, WE RECEIVED A TOTAL OF $13,430,938. FORM 990, PART V, LINES 1A AND 2A: IVI'S HEADQUARTERS IS BASED IN SEOUL, KOREA. SINCE THE ORGANIZATION IS NOT UNITED STATES BASED, THE ORGANIZATION HAS ONLY FILED (1) FORM W-2 FOR AN EMPLOYEE RESIDING IN THE UNITED STATES. AS OF DECEMBER 31, 2018, THE ORGANIZATION REPORTS 131 EMPLOYEES. FORM 990, PART V, LINE 4: IVI is a foreign organization. It is not required to file Form FinCEN 114 (Report of Foreign Bank and Financial Accounts). FORM 990, PART VI, LINE 7A: Director General of the Institute is also a voting member of the Board; thus, he/she can participate in the election of the Board. FORM 990, PART VI, LINE 11B: The finance team makes a first draft of form 990 and the related schedules. HR provides specific information on compensation and other teams provide fundraising, governance and management information. Public accountant prepares the return on IVI's behalf and this is reviewed in turn by the COO and Deputy CFO for accuracy. FORM 990, PART VI, LINE 12C: THE IVI HR PROVIDES A COPY OF THE CONFLICT OF INTEREST POLICY TO ALL DIRECTORS, OFFICERS AND STAFF TO COMPLETE ANNUALLY. NOT ONLY PERSONS WITH ACTUAL OR POTENTIAL CONFLICTS OF INTEREST BUT ALSO PERSONS WHO DO NOT HAVE ANY CONFLICTS OF INTEREST MUST SUBMIT A SIGNED COPY OF THE DISCLOSURE OF ACTUAL OR POTENTIAL CONFLICTS OF INTEREST TO THE IVI BOARD SECRETARIAT OR THE IVI HUMAN RESOURCES UNIT AS APPROPRIATE. THE CONFLICT COORDINATOR (DIRECTOR GENERAL) CREATES A CONFLICT COMMITTEE COMPOSED OF THREE OTHER MEMBERS OF THE IVI STAFF TO REVIEW CONFLICT OF INTEREST ISSUES THAT MAY ARISE. THE CONFLICT COMMITTEE SHALL BE RESPONSIBLE FOR ENSURING THAT RELEVANT CONFLICTS OF INTEREST, AND THE PROCEDURES TAKEN TO ELIMINATE, REDUCE OR MANAGE THOSE CONFLICTS, ARE DISCLOSED AT OR PRIOR TO ANY BOARD OF TRUSTEES MEETING. THE COMMITTEE SHALL KEEP A RECORD OF ALL ACTUAL AND POTENTIAL CONFLICTS OF INTEREST AND REPORT ANNUALLY THEREON TO THE BOARD OF TRUSTEES. IN CASE OF TRUSTEES, IVI BOARD SECRETARIAT PROVIDES A COPY OF THE CONFLICT OF INTEREST POLICY TO THE MEMBERS WHEN THEY FIRST JOIN, ALL MEMBERS MUST SUBMIT A SIGNED COPY OF THE DISCLOSURE OF ACTUAL AND POTENTIAL CONFLICTS OF INTEREST TO IVI. THE MEMBERS SHOULD REPORT THEIR CHANGES OF STATUS TO THE BOARD SECRETARIAT. FORM 990, PART VI, LINES 15A and 15B: THE IVI UNDERTAKES A COMPREHENSIVE COMPENSATION STUDY FOR ITS OFFICERS AND KEY EMPLOYEES. A COMPENSATION CONSULTANT CONDUCTS THE STUDY AND LOOKS AT COMPENSATION AMONG COMPARABLE ORGANIZATIONS WITH SIMILAR POSITIONS AND RESPONSIBILITIES IN ORDER TO PROVIDE MARKET DATA TO DETERMINE IVI STAFF MEMBER COMPENSATION. COMPENSATION IS SET BY INDEPENDENT PERSONS, AND CONTEMPORANEOUS DOCUMENTATION OF THE PROCESS IS RETAINED. FORM 990, PART VI, LINE 19: The IVI's governing documents-Establishment Agreement, Headquarters Agreement, Constitution and Amendments to the Constitution are available on IVI's website. The Summary of financial report is included in IVI's Annual report. FORM 990, PART XI, LINE 9: FOREIGN CURRENCY EXCHANGE LOSS -$142,604