2021-11-11T12:04:52-06:00 2020-08-31 521392008 GELMAN ROSENBERG & FREEDMAN 4550 MONTGOMERY AVE SUITE 800N BETHESDA MD 208142930 990 2020-01-01 830431851 PATH VACCINE SOLUTIONS PATH 2062853500 2201 WESTLAKE AVENUE NO 200 SEATTLE WA 98121 KELLY PRIESTLEY CONTROLLER 2062853500 2021-11-11 1 KELLY PRIESTLEY 999009999 RICHARD J LOCASTRO CPA P00288314 3019519090 2 AAL1 IAL1 2020 2022-09-23 18:48:47Z X KELLY PRIESTLEY 2201 WESTLAKE AVENUE NO 200 SEATTLE WA 98121 4835308 0 X WWW.PATH.ORG X 2006 WA SEE PART III, LINE 1. X 7 2 0 0 0 0 9933910 3827665 0 0 1027353 975772 0 31871 10961263 4835308 7606129 4799442 0 0 0 0 0 0 0 2140262 2182732 9746391 6982174 1214872 -2146866 38989543 0 36842677 0 2146866 0 X THE MISSION OF PATH VACCINE SOLUTIONS (PVS) WAS TO IMPROVE THE HEALTH OF CHILDREN IN LOW-RESOURCE SETTINGS BY ACCELERATING THE DEVELOPMENT OF VACCINES THAT WOULD BE EFFECTIVE AND AFFORDABLE FOR THOSE WHO NEED THEM MOST. (CONTINUED ON SCHEDULE O). 0 1 6982174 4799442 IN 2020, PVS CONTINUED OUR FIGHT AGAINST DIARRHEAL DISEASES, THE SECOND-LEADING CAUSE OF DEATH AMONG CHILDREN IN LOW-INCOME COUNTRIES. TO COMBAT ROTAVIRUS, A MAJOR CAUSE OF SEVERE DIARRHEA, WE CONTINUED CLINICAL DEVELOPMENT OF A NONREPLICATING ROTAVIRUS VACCINE CANDIDATE. THE PHASE 3 EFFICACY STUDY THAT BEGAN IN LATE 2019 WAS PAUSED THROUGHOUT 2020 DUE TO THE COVID-19 PANDEMIC IN ORDER TO BEST PROTECT THE HEALTH AND SAFETY OF PARTICIPATING INFANTS AND THEIR FAMILIES. PREPARATORY ACTIVITIES CONTINUED AT THE THREE CLINICAL SITES IN AFRICA THROUGHOUT THE YEAR TO ENSURE READINESS TO RESTART THE TRIAL ONCE CONDITIONS ALLOW. (CONTINUED ON SCHEDULE O).THIS VACCINE CANDIDATE IS ADMINISTERED AS AN INTRAMUSCULAR INJECTION AND COULD POTENTIALLY OVERCOME THE LOWER EFFICACY LEVELS SEEN IN LOW-RESOURCE SETTINGS FOR ORAL, LIVE ATTENUATED ROTAVIRUS VACCINES. IN ADDITION, PVS CONTINUED CONDUCTING A CASE-CONTROL STUDY IN INDIA TO EVALUATE THE EFFECTIVENESS OF SERUM INSTITUTE OF INDIA PVT. LTD.'S (SIIPL'S) LICENSED ROTAVIRUS VACCINE, ROTASIIL. THE STUDY WAS PAUSED FROM LATE MARCH 2020 TO LATE NOVEMBER 2020 DUE TO THE COVID-19 PANDEMIC.PVS CONTINUED TO SUPPORT CLINICAL TRIALS AND RESEARCH ON VACCINE CANDIDATES THAT MAY PROVIDE PROTECTION AGAINST ENTEROTOXIGENIC ESCHERICHIA COLI (ETEC) AND SHIGELLA, THE LEADING BACTERIAL CAUSES OF DIARRHEAL ILLNESS. CURRENTLY, THERE ARE NO LICENSED VACCINES AGAINST EITHER PATHOGEN. IN 2020, OUR WORK INCLUDED COMPLETING THE SUBMISSION OF RESULTS FROM A PHASE 1 TRIAL OF AN INJECTABLE, SUBUNIT ETEC VACCINE CANDIDATE TO THE US FOOD AND DRUG ADMINISTRATION. PVS ALSO PARTIALLY SUPPORTED THE FINAL DATA ANALYSIS FOR A PHASE 2B EFFICACY STUDY OF AN ORAL ETEC VACCINE CANDIDATE IN FINNISH TRAVELERS TO BENIN, REPORTING RESULTS IN MARCH 2020.ACHIEVING WORLD HEALTH ORGANIZATION PREQUALIFICATION IN 2019 FOR PNEUMOSIL (A LOW-COST PNEUMOCOCCAL CONJUGATE VACCINE [PCV] DEVELOPED BY PVS AND SIIPL) TRIGGERED A UNICEF AND SIIPL SUPPLY AGREEMENT IN 2020, WHICH AT $2.00 PER DOSE WAS MORE THAN 30 PERCENT LESS EXPENSIVE THAN OTHER PCVS, IMPROVING AFFORDABILITY FOR LOW- AND MIDDLE-INCOME COUNTRIES. IN ADDITION, PNEUMOSIL RECEIVED MARKET AUTHORIZATION IN INDIA, AND A PHASE 3 CLINICAL TRIAL OF PNEUMOSIL IN THE GAMBIA ALSO PROGRESSED.PVS ADDED TO THE RESPIRATORY SYNCYTIAL VIRUS (RSV) MATERNAL IMMUNIZATION KNOWLEDGE BASE IN 2020. WE PUBLISHED SEVERAL ARTICLES ABOUT THE ECONOMIC IMPACT IN LOW-INCOME COUNTRIES OF RSV AND OTHER ACUTE RESPIRATORY INFECTIONS AMONG INFANTS, AS WELL AS A MODELING EXERCISE ON THE IMPACT OF A HYPOTHETICAL MATERNAL RSV VACCINE IN PROTECTING INFANTS IN COUNTRIES SUPPORTED BY GAVI, THE VACCINE ALLIANCE.PVS ALSO CONTRIBUTED AN ARTICLE ON ANTENATAL CARE TIMING, WHICH COULD INFORM MATERNAL VACCINE COVERAGE, AND A STATE-OF-THE-ART REVIEW ON THE MATERNAL IMMUNIZATION LANDSCAPE. ADDITIONALLY, WE UPDATED OUR RSV VACCINE AND MONOCLONAL ANTIBODY SNAPSHOT (WHICH PROVIDES AN OVERVIEW OF THE INTERVENTION PRODUCT LANDSCAPE) AND TRIAL TRACKER (WHICH PROVIDES INFORMATION ON RELATED CLINICAL TRIALS). 6982174 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 1 1 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 X 7 2 0 0 0 0 0 0 0 1 1 0 0 1 1 1 1 1 1 0 0 0 WA X X KELLY PRIESTLEY CONTROLLER 2062853500 2201 WESTLAKE AVENUE NO 200 SEATTLE WA 98121 NIKOLAJ J GILBERT CHAIR AND PRESIDENT 1.00 39.00 X X 0 571940 44054 STEVEN B DAVIS RESIGNED 12020 CHAIR AND PRESIDENT 1.00 39.00 X X 0 249057 13602 DAVID C KASLOW VICE CHAIR 1.00 39.00 X X 0 427937 69391 BRIAN N NEVILLE SECRETARY AND TREASURER 1.00 39.00 X X 0 260514 36826 JERRY KUO DIRECTOR 1.00 39.00 X 0 252897 58226 ELAINE GIBBONS DIRECTOR 1.00 39.00 X 0 291278 76724 ANITA ZAIDI DIRECTOR 1.00 0.00 X 0 0 0 CHRIS KARP DIRECTOR 1.00 0.00 X 0 0 0 0 2053623 298823 0 0 1 0 0 46272 3781393 3827665 975772 975772 MISCELLANEOUS 900099 31871 31871 31871 4835308 0 0 1007643 4698344 4698344 101098 101098 46666 46666 8291 8291 24194 24194 513 513 35 35 2827 2827 638 638 9550 9550 SUBCONTRACTORS 2047869 2047869 LAB SUPPLIES 21068 21068 STORAGE 14314 14314 EQUIPMENT R&M 6767 6767 6982174 6982174 0 0 1054 0 0 0 0 0 0 0 0 58 0 0 21770 0 38966661 0 0 0 0 0 38989543 0 36842677 36842677 0 X 2125096 0 21770 0 2146866 0 38989543 0 -2146866 0 X 0 1 X 1 0 X X 1 PATH 911157127 7 1 6982174 0 1 6982174 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 1 CENTRAL AMERICA & THE CARIBBEAN 0 0 PROGRAM SERVICES ESSENTIAL MEDICINE 36997 EAST ASIA AND THE PACIFIC 0 4 PROGRAM SERVICES ESSENTIAL MEDICINE 57453 EUROPE 0 2 PROGRAM SERVICES ESSENTIAL MEDICINE 122668 EUROPE 0 0 GRANTMAKING 54109 SOUTH ASIA 0 1 PROGRAM SERVICES ESSENTIAL MEDICINE 192330 SUB-SAHARAN AFRICA 0 0 PROGRAM SERVICES ESSENTIAL MEDICINE 2775 SUB-SAHARAN AFRICA 0 0 GRANTMAKING 46989 0 7 0 0 0 7 513321 0 513321 EUROPE ESSENTIAL MEDICINE 31413 CHECK/WIRE EUROPE ESSENTIAL MEDICINE 21900 CHECK/WIRE SUB-SAHARAN AFRICA ESSENTIAL MEDICINE 46989 CHECK/WIRE 3 0 1 0 0 0 0 0 PART I, LINE 2: PVS PERFORMED RISK-BASED MONITORING OF SUBRECIPIENTS. POLICIES AND PROCEDURES WERE IN PLACE TO GUIDE PROJECT TEAMS' FINANCIAL AND TECHNICAL MONITORING OF SUBRECIPIENTS. TO PROVIDE THE MONITORING REQUIRED BY FUNDERS AND TO ENSURE GOOD STEWARDSHIP OF EVERY PROJECT, PVS USED RISK ASSESSMENTS, REPORTING, SITE VISITS, REGULAR CONTACT, OR OTHER MEANS TO PROVIDE RESPONSIBLE ASSURANCE THAT THE SUBRECIPIENT ADMINISTERED FUNDS IN COMPLIANCE WITH LAWS, REGULATIONS, AND PRIME AWARD TERMS, AND THAT THE SUBRECIPIENT ACHIEVED PERFORMANCE GOALS. PART III ACCOUNTING METHOD: 1 HENRY M JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE INC 6720-A ROCKLEDGE DRIVE STE 100 BETHESDA MD 20817 521317896 501(C)(3) 40283 ESSENTIAL MEDICINE ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI 1 GUSTAVE L LEVY PLACE NEW YORK NY 10029 136171197 501(C)(3) 82591 ESSENTIAL MEDICINE TULANE UNIVERSITY 6823 ST CHARLES AVE NEW ORLEANS LA 70112 720423889 501(C)(3) 169642 ESSENTIAL MEDICINE WALTER REED ARMY INSTITUTE OF RESEARCH US TREASURY 503 ROBERT GRANT AVE SILVER SPRING MD 20910 770706389 GOVERNMENT 19266 ESSENTIAL MEDICINE PATH 2201 WESTLAKE AVE SUITE 200 SEATTLE WA 98121 911157127 501(C)(3) 4386562 ESSENTIAL MEDICINE 5 0 PART I, LINE 2: PVS PERFORMED RISK-BASED MONITORING OF SUBRECIPIENTS. POLICIES AND PROCEDURES WERE IN PLACE TO GUIDE PROJECT TEAMS' FINANCIAL AND TECHNICAL MONITORING OF SUBRECIPIENTS. TO PROVIDE THE MONITORING REQUIRED BY FUNDERS AND TO ENSURE GOOD STEWARDSHIP OF EVERY PROJECT, PVS USED RISK ASSESSMENTS, REPORTING, SITE VISITS, REGULAR CONTACT, OR OTHER MEANS TO PROVIDE RESPONSIBLE ASSURANCE THAT THE SUBRECIPIENT ADMINISTERED FUNDS IN COMPLIANCE WITH LAWS, REGULATIONS, AND PRIME AWARD TERMS, AND THAT THE SUBRECIPIENT ACHIEVED PERFORMANCE GOALS. 0 0 0 0 0 0 0 0 0 NIKOLAJ J GILBERT CHAIR AND PRESIDENT 0 476585 0 0 0 95355 0 32249 0 11805 0 615994 0 0 DAVID C KASLOW VICE CHAIR 0 425987 0 0 0 1950 0 34200 0 35191 0 497328 0 0 ELAINE GIBBONS DIRECTOR 0 289328 0 0 0 1950 0 33296 0 43428 0 368002 0 0 JERRY KUO DIRECTOR 0 251067 0 0 0 1830 0 30616 0 27610 0 311123 0 0 BRIAN N NEVILLE SECRETARY AND TREASURER 0 258594 0 0 0 1920 0 27852 0 8974 0 297340 0 0 STEVEN B DAVIS RESIGNED 12020 CHAIR AND PRESIDENT 0 50912 0 156629 0 41516 0 11120 0 2482 0 262659 0 0 PART I, LINE 3 PATH VACCINE SOLUTIONS RELIES ON A RELATED ORGANIZATION, PATH, TO DETERMINE COMPENSATION. PATH USES THE FOLLOWING TO ESTABLISH COMPENSATION OF THE EXECUTIVE DIRECTOR: - COMPENSATION COMMITTEE - INDEPENDENT COMPENSATION CONSULTANT - COMPENSATION SURVEY OR STUDY - APPROVAL BY THE BOARD OR COMPENSATION COMMITTEE CASH 2021-08-31 2966046 ACTUAL AMOUNT 911157127 PATH 2201 WESTLAKE AVE SUITE 200 SEATTLE WA 98121 501(C)(3) 1 1 0 0 1 1 1 1 0 PART I, LINE 2E: PERSON(S) INVOLVED: DAVID KASLOWELAINE GIBBONSJERRY KUOBRIAN NEVILLENIKOLAJ GILBERTSTEVEN B. DAVIS PART I, LINE 2E: EXPLANATION OF INVOLVEMENT: EACH OF THE INDIVIDUALS LISTED ABOVE ARE, OR WERE, EMPLOYEES OF PATH, THE ORGANIZATION THAT PATH VACCINE SOLUTIONS (PVS) SUPPORTED, AND THE ORGANIZATION THAT RECEIVED THE ASSETS OF PVS UPON DISSOLUTION. THESE INDIVIDUALS WERE ALREADY EMPLOYED BY PATH PRIOR TO THE DISSOLUTION. MR. KUO, NEVILLE, AND GILBERT ARE ALSO OFFICERS OF PATH. FORM 990, PART III, LINE 1, DESCRIPTION OF ORGANIZATION MISSION FROM INITIAL DISCOVERY THROUGH CLINICAL TRIALS, PVS WORKED WITH COMMERCIAL PARTNERS, SUCH AS VACCINE MANUFACTURERS AND BIOTECHNOLOGY FIRMS, AND NONPROFIT PARTNERS, SUCH AS UNIVERSITIES AND RESEARCH INSTITUTIONS, TO SHORTEN THE TIMELINE FOR VACCINE DEVELOPMENT. FOR THESE PARTNERS, PVS PROVIDED FUNDING AND EXPERTISE IN PRECLINICAL DEVELOPMENT, MANUFACTURING, REGULATORY, AND CLINICAL DEVELOPMENT, WITH A FOCUS ON LOW-RESOURCE SETTINGS. IN RETURN, PARTNERS AGREED TO TERMS THAT HELPED ENSURE THE RESULTING PRODUCTS WERE AFFORDABLE AND AVAILABLE IN PUBLIC IMMUNIZATION PROGRAMS IN LOW- AND MIDDLE-INCOME COUNTRIES. IN JULY 2020, PVS ELECTED TO CEASE OPERATIONS VOLUNTARILY AND DISTRIBUTE ITS ASSETS (INCLUDING ALL REMAINING GRANT FUNDS) TO PATH, A WASHINGTON NONPROFIT CORPORATION FOR WHICH PVS WAS A SUPPORTING ORGANIZATION UNDER INTERNAL REVENUE CODE SECTION 509(A)(3), PURSUANT TO A PLAN OF DISTRIBUTION IN ACCORDANCE WITH THE PVS ARTICLES OF INCORPORATION AND SECTION 24.03.220(2) OF THE REVISED CODE OF WASHINGTON. THE PVS ARTICLES OF DISSOLUTION FOR VOLUNTARY DISSOLUTION WERE APPROVED BY THE STATE OF WASHINGTON SECRETARY OF STATE EFFECTIVE AUGUST 31, 2020. FORM 990, PART III, LINE 3 DURING THE YEAR, PATH VACCINE SOLUTIONS CEASED CONDUCTING OPERATIONS. SEE SCHEDULE N. FORM 990, PART VI, SECTION B, LINE 11B THE FORM 990 WAS PREPARED BY AN OUTSIDE ACCOUNTING FIRM USING INFORMATION PROVIDED BY PATH ACCOUNTING SERVICES STAFF. PATH SENIOR MANAGEMENT REVIEWED THE DRAFT FORM. A COPY OF THE DRAFT WAS SENT TO THE AUTHORIZED OFFICER FOR COMMENT (NOTE: FOLLOWING PVS'S DISSOLUTION, PVS'S BOARD HAS BEEN DISBANDED AND DELEGATED AUTHORIZED OFFICER NOMINATED TO OVERSEE FINAL DISSOLUTION ACTIVITIES INCLUDING COMMENTING ON THE 990 FORM). AFTER THE COMMENT PERIOD, THE PRINCIPAL FINANCIAL OFFICER SIGNED THE FORM. FORM 990, PART VI, SECTION B, LINE 12C PVS HAD A WRITTEN CONFLICT OF INTEREST POLICY UNDER WHICH ALL PVS BOARD MEMBERS AND OFFICERS HAD TO COMPLETE A CONFLICT OF INTEREST DISCLOSURE FORM EACH YEAR. PVS DID NOT HAVE EMPLOYEES. PVS WAS A SUPPORTING ORGANIZATION TO PATH WITHIN THE MEANING OF INTERNAL REVENUE CODE SECTION 509(A)(3), AND PVS CONTRACTED WITH PATH FOR MANAGEMENT SERVICES. PATH HAS A WRITTEN CONFLICT OF INTEREST POLICY UNDER WHICH ALL PATH BOARD MEMBERS, OFFICERS, AND STAFF AT HIGHER THAN A DESIGNATED LEVEL MUST COMPLETE A CONFLICT OF INTEREST DISCLOSURE FORM EACH YEAR. ALL PVS AND PATH DISCLOSURE FORMS ARE REVIEWED AND KEPT ON FILE. A CONFLICT MANAGEMENT PLAN IS DEVELOPED FOR ANY EMPLOYEE WITH A SIGNIFICANT ACTUAL OR PERCEIVED CONFLICT OF INTEREST. FORM 990, PART VI, SECTION C, LINE 19 PATH GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS ARE AVAILABLE TO THE PUBLIC UPON REQUEST; MOST DOCUMENTS ARE ALSO AVAILABLE ONLINE. PATH 2201 WESTLAKE AVE SUITE 200 SEATTLE WA 98121 911157127 GLOBAL HEALTH WA 501(C)(3) LINE 7 N/A 0 FOUNDATION FOR APPROPRIATE TECHNOLOGIES IN HEALTH - SWITZERLAND 207 ROUTE DE FERNEY 1218 LE GRAND-S GENEVA SZ EDUCATIONAL AND SCIENTIFIC PROMOTION OF HEALTH SZ 501(C)(3) PATH 1 PROGRAM FOR APPROPRIATE TECHNOLOGY IN HEALTH-KENYA ACS PLAZA 4TH FL LENANA RD PO BO NAIROBI KE EDUCATIONAL AND SCIENTIFIC PROMOTION OF HEALTH KE 501(C)(3) PATH 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0