2018-07-27T09:26:12-05:00 2017-12-31 BDO USA LLP 8401 GREENSBORO DRIVE 800 MCLEAN VA 22102 990 2017-01-01 311621592 INTERNATIONAL VACCINE INSTITUTE % EUNHYE LEE INTE 8228722803 snu research park 1 gwanak-ro seoul KS 151-742 PHILIP DRIVER DEP DIR OF FIN & OP 7038930600 2018-06-30 true JACOB COOK P01240455 7038930600 2017 2022-09-23 18:48:47Z JEROME H KIM SNU RESEARCH PARK 1 GWANAK-RO SEOUL KS 151-742 27796643 false X www.ivi.int X 1997 SEE SCHEDULE O 15 10 1 7 0 25948268 27484411 0 0 49021 76238 59613 235868 26056902 27796517 6221631 7865415 0 0 10343517 10302629 0 0 521617 8459876 7774133 25025024 25942177 1031878 1854340 23484429 20916339 18538434 14043688 4945995 6872651 X SEE SCHEDULE O true true 3744627 1955450 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. IVI and GeneOne Life Sciences signed a Collaboration and Access Agreement to support GeneOnes MERS DNA vaccine candidate in late 2016, and Phase I/IIa clinical trials for GeneOnes vaccine were approved by the Korean Ministry of Food and Drug Safety (KMFDS) in 2017. The toxicity study, required by KMFDS as part of their IND approval, was initiated in Dec 2017. 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. Other than clinical studies, an epidemiological study was initiated in 2017 to develop and analyze a dynamic model of MERS-CoV transmission in Korea, which would support the Korean regulatory bodies to make effective strategies on MERS-CoV vaccination and vaccine stockpiling. BSL-3 facilities were re-certified in mid-2017 and would be operated for laboratory testing on MERS-CoV clinical samples. 2783099 1015168 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, 2017, a total of 202,902 patients had been screened from all participating sites. From these screened patients, 5% (10,137/201,570) met the study inclusion criteria of which 76% (7,695/10,137) were enrolled in SETA 3343014 1981519 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 and exploratory steps for a Phase III trial have been undertaken. 11538776 2913278 21409516 true true false false false false false false false false true false false false true false true false false true true true false false true 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 15 10 true 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 Adel AF Mahmoud Chairman / Board of Trustee 1.0 0.0 X 750 0 0 George Bickerstaff Director / Board of Trustee 1.0 0.0 X 796 0 0 George Siber Director / Board of Trustee 1.0 0.0 X 1546 0 0 Joseph Kim Director / Board of Trustee 1.0 0.0 X 1638 0 0 Hanna Nohynek Director / Board of Trustee 1.0 0.0 X 1638 0 0 Fred Binka Director / Board of Trustee 1.0 0.0 X 1776 0 0 Lee Kyu Hyung Director / Board of Trustee 1.0 0.0 X 750 0 0 Jee Youngmee Director / Board of Trustee 1.0 0.0 X 1500 0 0 Jerome Kim Director General 40.0 0.0 X X 651772 0 149211 LEE JANGKEUN 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 CHRIS VARMA Director / Board of Trustee 1.0 0.0 X 0 0 0 MALCOLM SWEENEY Director / Board of Trustee 1.0 0.0 X 0 0 0 SHIN YOUNGSOO Director / Board of Trustee 1.0 0.0 X 0 0 0 SANJAY MADHAV MEHENDALE 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 331661 0 3919 Julia Lynch Deputy Dir. Gen of Dev & delvy 40.0 0.0 X 389071 0 60344 In Kyu Yoon Program Director, MERS and GDA 40.0 0.0 X 308380 0 72590 Viliam Pavliak Head of Vaccine Process Dev 40.0 0.0 X 264022 0 46120 Jean-Louis Excler Head of Clinical Dev & Reg. 40.0 0.0 X 221133 0 8210 Yun Chon Head of Biostatistics & Data 40.0 0.0 X 217822 0 36753 Kyung-Taik Han Deputy Dir. 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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. FUNDRAISING 28754 28754 259 259 126 0 29013 28754 259 126 126 133 true INC RESEARCH LLC 3201 BEECHLEAF CT STE 600 RALEIGH NC 27604 330723120 190664 PROGRAM SERVICE INNOVATIONS FOR GLOBAL HEALTH 3240 HURON PEAK AVE SUPERIOR CO 80027 201059464 501(C)(3) 66367 PROGRAM SERVICE THE ALBERT B SABIN VACCINE INSTITUTE 2000 PENN AVE NW WASHINGTON DC 20006 061389829 501(C)(3) 45117 PROGRAM SERVICE CHILD HEALTH & RESEARCH FOUNDATION 1 N LEXINGTON AVE WHITE PLAINS NY 10601 272415391 501(C)(3) 36175 PROGRAM SERVICE BECTON DICKINSON INTERNATIONAL 1 becton drive franklin lakes NJ 07417 740003730 15308 PROGRAM SERVICE 3 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. 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Gen of Gov Affairs 179616 0 0 0 30090 0 0 0 774 0 210480 0 0 0 Manki Song Head of Clinical Research Lab 164955 0 0 0 28444 0 2120 0 1905 0 197424 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 8386 5066 false true true JULIA LYNCH EMPLOYEE EDUCATION X 14693 4597 false true true JULIA LYNCH EMPLOYEE HOUSING LOAN X 13270 1905 false true true PHIL DRIVER EMPLOYEE HOUSING LOAN X 24934 24934 false true true VILIAM PAVLIAK EMPLOYEE HOUSING LOAN X 16464 16464 false true true FLORIAN MARKS EMPLOYEE HOUSING LOAN X 25677 25677 false true true SUSHANT SAHASTRABUDDHE EMPLOYEE HOUSING LOAN X 9672 7254 false true true VINAY KUMAR GUPTA EMPLOYEE HOUSING LOAN X 5592 2424 false true true SUDEEP KOTHARI EMPLOYEE EDUCATION X 32153 0 false true true AYAN DEY EMPLOYEE HOUSING LOAN X 26352 26352 false true true PAOLA RUSSO EMPLOYEE HOUSING LOAN X 25872 25872 false true true 140545 X ROK EQUIPMENT 0 26338 0 false true false 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 Mozambique Cholera Prevention and surveillance(MOCA) is to conduct Cholera Vaccination and Surveillance study in Cuamba district in Mozambique. The goal of this project is to prevent cholera epidemics and empower local public health service for sustainable cholera and other vaccine-preventable disease surveillance and control. korea international Cooperation Agency (KOICA)donated $3,000,000 for 28 months of project duration from June 2017 to September 2019.The three project activities carried out in 2017 under MOCA grant. First, IVI had contract with INS and Wateraid in Mozambique to carry out MOCA project from June 2017 to September 2019. Second, IVI prepared to have import permit on Euvichol in Mozambique and 1st half of 2018, we have received import permit in Mozambique. Euvichol will be used for Cholera Vaccination in July 2018 for more than 180,000 persons (over the age of one year) as target in Cuamba district. The end active, surveillance site assessment was made to discuss and prepare for the surveillance activities in 2018. IVI staff went to Mozambique to select local health care and had official meeting with MOH(INS, Mozambique) for preparation of vaccination campaign and surveillance field work in following year. FORM 990, PART V, LINE 3 GDAC (Global Dengue and Aedes-transmitted Diseases Consortium) is a global alliance to fight Aedes-mosquito-transmitted diseases including dengue, Zika, yellow fever and chikungunya under one strategic umbrella, created in August 2016 by merging the Dengue Vaccine Initiative (DVI) with the Partnership for Dengue Control. Serving as the Secretariat of the consortium, IVI has also been conducted disease burden and epidemiology studies, laboratory testing and policy & access activities. IVI continued to make progress in dengue in 2017. Field studies were completed at all sites, including three studies in Africa, and additional lab testing is underway at IVI. GDAC convened its annual meetings, including the Asia-Pacific Dengue Prevention Board (APDPB) in Thailand in June 2017 and the Americas Dengue Prevention Board (AmDPB) in Brazil in August 2017, where key issues on the topic of "Dengue in the time of Zika" were addressed. GDAC continued working on capacity building with National Regulatory Authorities (NRAs) as well. In addition to the NRAs of "first wave" countries for dengue vaccine registration (Brazil, Colombia, Indonesia, Malaysia, Mexico, Philippines, and Thailand), the NRAs of Vietnam and Sri Lanka were added in 2017. Dengue burden field studies and part of policy & access activities of GDAC funded by Bill & Melinda Gates Foundation were completed as of end 2017; however, other funds from multiple industry partners continue supporting GDAC activities. GDAC also started working with six developing country manufacturer licensees of the US NIH dengue vaccine candidate in 2017, supported by funding from NIH, to develop a central database for clinical trial data generated by the manufacturing licensees. 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, 2017, THE ORGANIZATION REPORTS 126 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 2 Adel Mahmoud is a Board member of Inovio Pharmaceuticals where Joseph Kim is a CEO & President at. They are both members of IVI Board of Trustees. 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 CFO 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 GAIN $72,316