2023-04-07T11:41:57-05:00 2022-06-30 860683059 BEACHFLEISCHMAN PLLC 1985 E RIVER ROAD SUITE 201 TUCSON AZ 85718 990 2021-07-01 201991334 CRITICAL PATH INSTITUTE CRIT 5205473440 1840 E RIVER ROAD 100 TUCSON AZ 85718 KEVIN B PERKINS CFO 5205473440 2023-04-05 1 KEVIN PERKINS 999009999 KELLY L MELTZER CPA P00633511 5203214600 2023-04-05 3 AAL1 IAL1 2021 2023-04-26 12:10:37Z X DANIEL JORGENSEN 1840 E RIVER ROAD 100 TUCSON AZ 85718 31176116 0 X C-PATH.ORG X 2004 AZ INTERNATIONAL COLLABORATIONS AND NOVEL TOOLS TO ENABLE FASTER DEVELOPMENT OF SAFE MEDICAL PRODUCTS 13 13 154 13 0 0 17810315 23061454 6610023 8108029 5817 6633 942 0 24427097 31176116 3294397 4230463 0 0 14630286 17392416 0 0 0 5080822 7977401 23005505 29600280 1421592 1575836 18494765 19962086 8046061 7937546 10448704 12024540 X THE CRITICAL PATH INSTITUTE IS A CATALYST IN THE DEVELOPMENT OF NEW APPROACHES THAT ADVANCE MEDICAL INNOVATION AND REGULATORY SCIENCE. THIS IS ACHIEVED BY LEADING TEAMS THAT SHARE DATA, KNOWLEDGE AND EXPERTISE RESULTING IN SOUND, CONSENSUS BASED SCIENCE. 0 0 7578558 1557585 0 RARE DISEASE CURES ACCELERATOR-DATA AND ANALYTICS PLATFORM (RDCA-DAP) - SEE SCHEDULE O 2989093 1611511 0 CURE DRUG REPURPOSING COLLABORATORY (CDRC) - SEE SCHEDULE O 1713473 239633 0 REAL-WORLD DATA ANALYTICS PLATFORM (RW-DAP) - SEE SCHEDULE O 12905155 821734 8108029 CRITICAL PATH INSTITUTE ALSO EXECUTES OTHER PROJECTS AND CONSORTIA IN AREAS INCLUDING THERAPEUTICS FOR THE ATAXIAS, POLYCYSTIC KIDNEY DISORDER, ALZHEIMER'S DISEASE, PARKINSON'S, TB, SICKLE CELL, TYPE ONE DIABETES, DUCHENNE MUSCULAR DYSTROPHY, MODEL INFORMED DRUG DEVELOPMENT, PATIENT-REPORTED OUTCOME, ELECTRONIC CLINICAL OUTCOME ASSESSMENT, RARE DISEASE CLINICAL OUTCOME ASSESSMENT, TRANSPLANT THERAPEUTICS, PREDICTIVE SAFETY TESTING, AND OTHERS. 12905155 821734 8108029 25186279 1 1 0 1 0 0 0 0 0 0 1 0 0 0 1 1 0 1 0 0 1 1 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 1 38 0 1 154 1 0 1 EI NL 0 0 0 0 0 0 0 0 0 0 X 13 13 1 0 0 0 0 0 0 1 1 0 0 1 1 1 1 1 1 1 1 0 X KEVIN B PERKINS CFO 5206478382 1840 E RIVER ROAD 100 TUCSON AZ 85718 MR M WAINWRIGHT FISHBURN JR CHAIRMAN 1.00 X X 0 0 0 MR JEFFERY JACOB VICE CHAIRMAN 1.00 X X 0 0 0 DR TIMOTHY R FRANSON BOARD MEMBER 1.00 X 0 0 0 MS MARA G ASPINALL BOARD MEMBER 1.00 X 0 0 0 DR ROBERT M CALIFF BOARD MEMBER 1.00 X 0 0 0 MS KAY HOLCOMBE BOARD MEMBER 1.00 X 0 0 0 MR PETER BARTON HUTT BOARD MEMBER 1.00 X 0 0 0 MR SHAUN A KIRKPATRICK BOARD MEMBER 1.00 X 0 0 0 MR ALAN G LEVIN BOARD MEMBER 1.00 X 0 0 0 MR JAMES W NEWMAN BOARD MEMBER 1.00 X 0 0 0 DR PAULA J OLSIEWSKI BOARD MEMBER 1.00 X 0 0 0 DR TOMAS SALMONSON BOARD MEMBER 1.00 X 0 0 0 DR ALASTAIR JJ WOOD BOARD MEMBER 1.00 X 0 0 0 DR CRAIG BRATER BOARD MEMBER 1.00 X 0 0 0 MS KRISTEN SWINGLE COO & INTERIM PRESIDENT 40.00 X 307667 0 39060 MR KEVIN PERKINS CHIEF FINANCIAL OFFICER & TREASURER 40.00 X 85373 0 10431 MR LEWIS BARBIERI CORPORATE SECRETARY 40.00 X 129328 0 21660 MR RICHARD LIWSKI CHIEF TECHNOLOGY OFFICER 40.00 X 225262 0 25094 DR KLAUS ROMERO CHIEF SCIENCE OFFICER 40.00 X 250697 0 32919 DR SUDHIR SIVAKUMARAN VICE PRESIDENT/EXECUTIVE DIRECTOR 40.00 X 219854 0 27685 DR JOHN MICHAEL SAUER SENIOR VICE PRESIDENT 40.00 X 156176 0 39641 DR STEPHEN COONS SENIOR VICE PRESIDENT 40.00 X 217922 0 28464 DR JEFF BARRETT SENIOR VICE PRESIDENT 40.00 X 220780 0 36346 DR INISH O'DOHERTY VICE PRESIDENT 40.00 X 193708 0 14556 DR MARCO SCHITO EXECUTIVE DIRECTOR 40.00 X 183386 0 27703 DR DIANE STEPHENSON EXECUTIVE DIRECTOR 40.00 X 191012 0 24998 MS SONYA EREMENCO EXECUTIVE DIRECTOR 40.00 X 183735 0 28244 DR JOSEPH SCHEEREN PRESIDENT & CEO THRU 03/19/21 40.00 X 84936 0 12860 2649836 0 369661 33 1 1 0 ARIDHIA INFORMATICS LIMITED 163 BATH STREET GLASGOW UK IT SERVICES 1077973 ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE ROAD INDIANAPOLIS IN 46250 RESEARCH SERVICES 525000 TRIPLE POINTE HOLDINGS LLC 378 PEAKHAM ROAD SUDBURY MA 01776 CONSULTANT 261600 LOTOS NILE PO BOX 90245 NASHVILLE TN 37209 PUBLIC RELATIONS 251581 EPHIBIAN INC 3180 N SWAN ROAD TUCSON AZ 85712 IT SERVICE 173311 5 16906032 6155422 23061454 RESEARCH SUPPORT FEES 541700 7799572 7799572 OTHER REVENUE 900099 308457 308457 8108029 6633 6633 31176116 8108029 0 6633 X 3914930 3914930 315533 315533 1929659 978065 951594 12444580 11479451 965129 899761 835065 64696 1091459 984565 106894 1026957 895190 131767 52510 52510 71770 71770 3750908 3047904 703004 325459 59154 266305 290140 60639 229501 2229778 1803488 426290 599614 459226 140388 190740 157569 33171 209651 133024 76627 34813 4806 30007 89009 89009 DUES AND SUBSCRIPTIONS 101658 57164 44494 LOSS FROM SUBSIDIARY 20144 20144 MISCELLANEOUS 11207 506 10701 29600280 25186279 4414001 0 2563917 2618376 13473971 13932086 1572024 2336559 365250 804595 38270 46337 409253 336661 90400 72592 249017 0 141916 151541 18494765 19962086 1587126 1958777 6375005 5896296 83930 82473 8046061 7937546 X 10448704 12024540 10448704 12024540 18494765 19962086 1575836 0 X 0 1 X 1 1 1 X 10019550 10698823 12978641 17810315 23061454 74568783 10019550 10698823 12978641 17810315 23061454 74568783 12014876 62553907 83667 215046 156753 5817 6633 467916 75036699 31096324 0.83360 0.71640 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 0 0 29600280 29600280 1000000 250000 0 0 918648 1000000 1000000 1000000 3918648 5877972 229662 250000 250000 250000 979662 1469493 PART II-A, LINE 1B C-PATH DOES NOT LOBBY FOR OR AGAINST ANY SPECIFIC LEGISLATION. C-PATH DOES EXPEND A MODEST AMOUNT OF TIME AND MONEY TO EDUCATE LEGISLATORS AND THEIR STAFF IN THE AREA OF DRUG DEVELOPMENT. 42014 42014 0 136750 129263 7487 230489 165384 65105 72592 DEFERRED RENT 82473 82473 X PART X, LINE 2: FINANCIAL STATEMENT FIN 48 (ASC 740) FOOTNOTE: C-PATH IS EXEMPT FROM INCOME TAXES UNDER BOTH FEDERAL (INTERNAL REVENUE CODE SECTION 501(C)(3)) AND ARIZONA INCOME TAX LAWS, AND IS CLASSIFIED AS OTHER THAN A PRIVATE FOUNDATION UNDER INTERNAL REVENUE CODE SECTION 509(A)(1). INCOME FROM CERTAIN ACTIVITIES NOT DIRECTLY RELATED TO C-PATH'S TAX-EXEMPT PURPOSE, HOWEVER, MAY BE SUBJECT TO TAXATION AS UNRELATED BUSINESS TAXABLE INCOME (UBTI). 1 NORTH AMERICA (CANADA) 0 0 BUSINESS/VENDOR SERVICES IT SERVICES 17955 EUROPE (FRANCE, GERMANY, SLOVENIA, SWEDEN, UNITED KINGDOM) 0 0 PROGRAM SERVICES CLINICAL RESEARCH, CONSULTING, LICENSING 2070750 EUROPE (UNITED KINGDOM) 0 0 GRANTS TO RECIPIENTS LOCATED IN REGION CLINICAL RESEARCH 315533 EUROPE (INCLUDING ICELAND & GREENLAND) 0 0 INVESTMENT -14752 0 0 0 0 0 0 2389486 0 2389486 EUROPE (INCLUDING ICELAND & GREENLAND) SUBAWARD 315533 WIRE TRANSFER 0 0 1 1 0 0 0 PART I, LINE 2: CRITICAL PATH INSTITUTE ENTERS INTO SUBAWARD AGREEMENTS WITH SUBRECIPIENTS AND REVIEWS PROGRESS DELIVERABLES AND COSTS. PART III ACCOUNTING METHOD: 1 NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD) 1900 CROWN COLONY DRIVE SUITE 310 QUINCY MA 02169 133223946 501(C)(3) 1604706 0 SUBAWARD MAYO CLINIC 200 FIRST STREET SW ROCHESTER MN 55905 416011702 501(C)(3) 132270 0 SUBAWARD JAEB CENTER FOR HEALTH RESEARCH 15310 AMBERLY DRIVE SUITE 350 TAMPA FL 33647 593187624 501(C)(3) 28251 0 SUBAWARD TUFTS MEDICAL CENTER INC 800 WASHINGTON STREET RF BOX 453 BOSTON MA 02111 043400617 501(C)(3) 101895 0 SUBAWARD INSTITUTE FOR ADVANCED CLINICAL TRIALS FOR CHILDREN 9211 CORPORATE BLVD SUITE 260 ROCKVILLE MD 20850 812076517 501(C)(3) 137738 0 SUBAWARD NORTHWESTERN UNIVERSITY 633 CLARK STREET ROOM G-547 EVANSTON IL 60208 362167817 501(C)(3) 45364 0 SUBAWARD & RESEARCH SOCIETY OF CRITICAL CARE MEDICINE 35083 EAGLE WAY CHICAGO IL 60678 237104387 501(C)(3) 835334 0 SUBAWARD JOHNS HOPKINS UNIVERSITY 12529 COLLECTIONS CENTER DRIVE CHICAGO IL 60693 520595110 501(C)(3) 263051 0 SUBAWARD EMORY UNIVERSITY 1599 CLIFTON ROAD NE 4TH FLOOR ATLANTA GA 30322 580566256 501(C)(3) 314286 0 SUBAWARD UNIVERSITY OF ROCHESTER 265 CRITTENDEN BLVD CU420694 ROCHESTER NY 14642 160743209 501(C)(3) 186530 0 SUBAWARD THE REGENTS OF THE UNIV OF MICHIGAN 1000 VICTORS WAY SUITE 1A ANN ARBOR MI 48108 386006309 501(C)(3) 183750 0 SUBAWARD RUTGERS THE STATE UNIVERSITY 33 KNIGHTBRIDGE RD 2ND FL EAST PISCATAWAY NJ 08854 226001086 501(C)(3) 81755 0 SUBAWARD 12 12 PART I, LINE 2: CRITICAL PATH INSTITUTE ENTERS INTO SUBAWARD AGREEMENTS WITH SUBRECIPIENTS AND REVIEWS PROGRESS DELIVERABLES AND COSTS. X X X X X 0 0 0 0 0 0 0 1 0 MS KRISTEN SWINGLE COO & INTERIM PRESIDENT 281092 0 26575 0 0 0 21334 0 17726 0 346727 0 0 0 DR KLAUS ROMERO CHIEF SCIENCE OFFICER 224684 0 26013 0 0 0 19728 0 13191 0 283616 0 0 0 DR JEFF BARRETT SENIOR VICE PRESIDENT 204176 0 16604 0 0 0 18631 0 17715 0 257126 0 0 0 MR RICHARD LIWSKI CHIEF TECHNOLOGY OFFICER 203658 0 21604 0 0 0 17538 0 7556 0 250356 0 0 0 DR SUDHIR SIVAKUMARAN VICE PRESIDENT/EXECUTIVE DIRECTOR 198953 0 20901 0 0 0 17787 0 9898 0 247539 0 0 0 DR STEPHEN COONS SENIOR VICE PRESIDENT 201236 0 16686 0 0 0 16929 0 11535 0 246386 0 0 0 DR DIANE STEPHENSON EXECUTIVE DIRECTOR 183586 0 7426 0 0 0 12012 0 12986 0 216010 0 0 0 MS SONYA EREMENCO EXECUTIVE DIRECTOR 176395 0 7340 0 0 0 15267 0 12977 0 211979 0 0 0 DR MARCO SCHITO EXECUTIVE DIRECTOR 171856 0 11530 0 0 0 14783 0 12920 0 211089 0 0 0 DR INISH O'DOHERTY VICE PRESIDENT 179398 0 14310 0 0 0 13550 0 1006 0 208264 0 0 0 DR JOHN MICHAEL SAUER SENIOR VICE PRESIDENT 156176 0 0 0 0 0 29290 0 10351 0 195817 0 0 0 MR LEWIS BARBIERI CORPORATE SECRETARY 124310 0 5018 0 0 0 10439 0 11221 0 150988 0 0 0 DR JOSEPH SCHEEREN PRESIDENT & CEO THRU 03/19/21 84936 0 0 0 0 0 9442 0 3418 0 97796 0 0 0 PART I, LINE 7 CRITICAL PATH AWARDS VARIABLE COMPENSATION BASED ON PERFORMANCE AND WITH GUIDANCE FROM THE COMPENSATION COMMITTEE. FORM 990, PART III, LINE 4A, DESCRIPTION OF PROGRAM SERVICES THE RARE DISEASE CURES ACCELERATOR-DATA AND ANALYTICS PLATFORM (RDCA-DAP) IS AN FDA-FUNDED INITIATIVE THAT PROVIDES A CENTRALIZED AND STANDARDIZED INFRASTRUCTURE TO SUPPORT AND ACCELERATE RARE DISEASE CHARACTERIZATION, WITH THE GOAL OF ACCELERATING THERAPY DEVELOPMENT ACROSS RARE DISEASES. THIS PLATFORM IS MADE POSSIBLE THROUGH A COLLABORATIVE GRANT FROM THE FDA AND IN PARTNERSHIP WITH THE NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD). RDCA-DAP PROMOTES THE SHARING OF EXISTING PATIENT-LEVEL DATA AND ENCOURAGES THE STANDARDIZATION OF NEW DATA COLLECTION. BY INTEGRATING SUCH DATA IN A REGULATORY-GRADE FORMAT SUITABLE FOR ANALYTICS, RDCA- DAP ACCELERATES THE UNDERSTANDING OF DISEASE PROGRESSION (INCLUDING SOURCES OF VARIABILITY TO OPTIMIZE THE CHARACTERIZATION OF SUBPOPULATIONS), CLINICAL OUTCOME MEASURES AND BIOMARKERS, AND FACILITATES THE DEVELOPMENT OF MATHEMATICAL MODELS OF DISEASE AND INNOVATIVE CLINICAL TRIAL DESIGNS. RDCA-DAP IS POSITIONED TO GENERATE SOLUTIONS TO DRUG DEVELOPMENT BOTTLENECKS. ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) SIGNED 24 DATA CONTRIBUTION AGREEMENTS (DCAS), TWELVE MOUS AND THIRTEEN NDAS NEGOTIATED AND SIGNED TO DATE TO DATE; (2) THE RDCA-DAP PLATFORM CURRENTLY INCLUDES OVER 75 RARE DISEASE DATA SETS REPRESENTING 25 DISEASE STATES FROM 53,001 PATIENTS; (3) MANUSCRIPT, "INNOVATIONS IN THERAPY DEVELOPMENT FOR RARE DISEASES THROUGH THE RARE DISEASE CURES ACCELERATOR DATA AND ANALYTICS PLATFORM," SUBMITTED TO THERAPEUTIC INNOVATION & REGULATORY SCIENCE COMPLETED AND PUBLISHED WHITE PAPER ON RDCA-DAP WEBSITE TITLED "RARE DISEASES CURES ACCELERATOR DATA AND ANALYTICS PLATFORM (RDCA-DAP) BEST PRACTICES AND RECOMMENDATIONS FOR FAIR DATA, TOWARD ALIGNMENT WITH INTERNATIONAL REGULATORY AGENCIES," SHARING LESSONS LEARNED FOR STORING AND SHARING DATA AND STRATEGIES FOR COLLECTING REGISTRY DATA THAT WILL MAXIMIZE IMPACT ON THE DRUG AND DIAGNOSTIC TOOLS ECOSYSTEM; (4) TECHNICAL ADVISORY GROUP MEETING HELD WITH FDA AND NORD TO DEMONSTRATE THE PLATFORM TO A WIDER FDA AUDIENCE. FORM 990, PART III, LINE 4B, DESCRIPTION OF PROGRAM SERVICES THE GOAL OF THE CURE DRUG REPURPOSING COLLABORATORY (CDRC) IS TO BE THE CENTRAL GLOBAL SOURCE OF VALIDATED REAL-WORLD DATA OF REPURPOSED DRUGS FOR DISEASES WITH THE HIGHEST LEVELS OF UNMET MEDICAL NEED. TO ACCOMPLISH THIS GOAL, CDRC IS WORKING WITH MULTIPLE STAKEHOLDERS TO DEVELOP OPEN-SOURCED TOOLS TO AUTOMATE THE EXTRACTION, AGGREGATION, ANALYSIS AND SHARING OF KEY CLINICAL DATA ELEMENTS FROM ELECTRONIC HEALTH RECORDS IN A DEIDENTIFIED MANNER REGARDLESS OF THE VENDOR OR DATA MODEL FOR IDENTIFYING FDA APPROVED DRUGS PRESCRIBED FOR NEW INDICATIONS. IN ADDITION, CDRC IS WORKING TO DEVELOP A WEB-BASED PATIENT PORTAL FOR PATIENTS TO PROVIDE THEIR TREATMENT JOURNEY EXPERIENCE TO ALLEVIATE SYMPTOMS OF DISEASE THAT IS NOT ON THE CURRENT DRUG LABEL OR AMELIORATE SIDE EFFECTS OF EXISTING FDA APPROVED AND PRESCRIBED TREATMENTS. THE ANALYSIS OF REAL-WORLD DATA FROM BOTH CLINICIANS AND PATIENTS WILL BE USED TO GENERATE HYPOTHESIS THAT CAN SUPPLEMENT EXISTING CLINICAL TRIAL DATA OR INFORM CLINICAL TRIAL DESIGN IN HOW EXISTING FDA APPROVED DRUGS CAN BE EVALUATED IN RANDOMIZED TRIALS TO ASSESS TREATMENT EFFICACY. THE UTILITY OF SYSTEMATICALLY COLLECTING EXISTING REAL-WORLD DATA TO GENERATE REAL-WORLD EVIDENCE AND LINKAGE TO CLINICAL TRIALS WILL HELP INFORM PRESCRIBERS HOW TO MAXIMIZE THE USE OF EXISTING FDA APPROVED DRUGS AND LEVERAGE EXISTING DATA TO CHANGE CLINICAL PRACTICE AND HELP ADDRESS THE HIGH UNMET CLINICAL NEED OF PATIENTS WITH DISEASES THAT HAVE LITTLE OR NO TREATMENT OPTIONS. ACCOMPLISHMENTS THIS YEAR INCLUDE: (1) DESIGNED AND CONSTRUCTED A BIOINFORMATIC DATA PROCESSING PIPELINE IN AMAZON WEB SERVICES (AWS) TO DIGEST DATA FROM CURE ID AND GENERATE INFORMATIVE INSIGHTS FOR DRUG REPURPOSING; (2) DEFINED RARE DISEASE PILOTS FOR ONCOLOGY (SARCOMA SUBTYPES: ANGIOSARCOMA, PERIVASCULAR EPITHELIOID CELL TUMORS AND EPITHELIOID HEMANGIOENDOTHELIOMA) AND NON-ONCOLOGY (RASOPATHIES WITH THE EXCEPTION OF NEUROFIBROMATOSIS TYPE 1), ENGAGED CLINICAL EXPERTS TO REVIEW AND DEFINE DATA ELEMENTS, ESTABLISHED DRUG REPURPOSING TASK FORCE WITH PATIENT GROUPS; (3) SECURED FUNDING FOR CREATE FROM THREE PHARMA COMPANIES WHO EXPECT TO COME TO MARKET SOON WITH NEW PRODUCTS FOR IBD BUT THE PROJECT REQUIRES ADDITIONAL INVESTMENT TO BUILD THE REGISTRY INFRASTRUCTURE; (4) FINALIZED PROTOCOL SYNOPSIS AND IDENTIFIED PILOT SITES (BAYLOR, HOPKINS AND UAB) FOR SECURING CONGENITAL CMV DATA FROM EHRS; (5) SUCCESSFULLY UPLOADED COVID-19 DATA AUTOMATICALLY EXTRACTED FROM EHR FROM FIRST PILOT SITE TO C-PATH USING THE EDGE TOOL; (6) ESTABLISHED WHO COLLABORATION ON SEXUALLY TRANSMITTED INFECTION TREATMENT FAILURES FOR GONORRHEA AND MYCOPLASMA GENETALIUM. FORM 990, PART III, LINE 4C, DESCRIPTION OF PROGRAM SERVICES THE OBJECTIVES OF C-PATH'S REAL-WORLD DATA ANALYTICS PLATFORM (RW-DAP) PROJECT ARE TO ASSIMILATE CLINICAL TRIAL DATASETS, ELECTRONIC HEALTH RECORDS (EHR), AND REGISTRY DATA FROM GLOBAL PARTNERS AND GENERATE ACTIONABLE SOLUTIONS TO ACCELERATE DRUG DEVELOPMENT IN NEONATOLOGY. THIS PROJECT ENTAILS GENERATING A REAL-WORLD DATA ANALYTICS PLATFORM (RW-DAP) THAT WILL AGGREGATE, STANDARDIZE, AND INTEGRATE PATIENT-LEVEL REAL WORLD DATA (RWD) TO (1) ESTABLISH NEONATAL LABORATORY VALUE REFERENCE RANGES BY GESTATIONAL AND POSTNATAL AGE, AND OTHER PATIENT-LEVEL CHARACTERISTICS, AND (2) DEVELOP A QUANTITATIVE DISEASE PROGRESSION MODEL FOR BRONCHOPULMONARY DYSPLASIA (ONE OF THE MOST CHALLENGING RESPIRATORY COMPLICATIONS OF PREMATURITY). ANY GAPS THAT INTERFERE WITH OPTIMAL USE OF EXISTING RWD WILL BE IDENTIFIED, AND SOLUTIONS THAT WILL IMPROVE THE USABILITY OF RWD IN THE FUTURE WILL BE PROPOSED. DURING THE PAST ONE YEAR, WE HAVE CONTINUED TO MEET AND MAKE SIGNIFICANT PROGRESS WITH PHARMACEUTICAL COMPANIES, ACADEMIC INSTITUTES, AND NEONATAL REGISTRY NETWORKS FOR THE PROJECT. DISCUSSIONS HAVE BEEN ONGOING WITH 22 ACADEMIC INSTITUTES WHO HAVE INDICATED A WILLINGNESS TO COLLABORATE WITH US. IN AGGREGATE, C-PATH HAS RECEIVED DATASETS REPRESENTING >200,000 PATIENTS AND EXPECTS 100,000 ADDITIONAL PATIENTS IN FUTURE DATASETS WITH PARTNERS AND COLLABORATORS. IN ORDER TO FOCUS AND LEVERAGE THE EXPERIENCE AND EXPERTISE OF THE LARGE INC STAKEHOLDER NETWORK, WE HAVE CREATED BPD AND LABORATORY VALUE WORKGROUPS. THE BPD WORKGROUP HAS 30 MEMBERS, COMPRISED OF ACADEMIC, INDUSTRY, AND REGULATORY RESEARCHERS WITH EXPERTISE IN BPD RESEARCH AS WELL AS PARENT MEMBERS. THE LABORATORY VALUE WORKGROUP HAS 20 MEMBERS, COMPRISED OF ACADEMIC AND INDUSTRY RESEARCHERS WHO HAVE A LONGSTANDING INTEREST IN CREATING GENERALIZABLE REFERENCE RANGES FOR LABORATORY VALUES IN NEONATES. FORM 990, PART VI, SECTION A, LINE 2 PETER HUTT AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. WAIN FISHBURN AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. JEFF JACOB AND SHAUN KIRKPATRICK HAVE A BUSINESS RELATIONSHIP. TOMAS SALMONSON AND JEFF JACOB HAVE A BUSINESS RELATIONSHIP. FORM 990, PART VI, SECTION B, LINE 11B FORM 990 IS PREPARED BY AN EXTERNAL CPA FIRM USING INFORMATION PROVIDED BY THE ORGANIZATION. THE FORM IS REVIEWED BY THE ORGANIZATION'S CFO, PRESIDENT/COO, CEO, THE BOARD AUDIT, FINANCE, AND RISK COMMITTEE, AND THE BOARD OF DIRECTORS PRIOR TO BEING FINALIZED. FORM 990, PART VI, SECTION B, LINE 12C ALL MEMBERS OF THE BOARD OF DIRECTORS AND ALL OFFICERS OF THE ORGANIZATION ARE REQUIRED TO FILL OUT A CONFLICT OF INTEREST FORM ANNUALLY. THE RESULTS ARE COMPILED AND REVIEWED BY THE BOARD'S AUDIT, FINANCE, AND RISK COMMITTEE. ANY ACTUAL OR PERCEIVED CONFLICTS THAT HAVE THE POTENTIAL TO BIAS ANY DISCUSSIONS OR DECISIONS BY THE BOARD ARE DISCUSSED BY THE BOARD. ANY DIRECTOR WITH A REAL OR POTENTIAL CONFLICT WILL RECUSE THEMSELVES FROM ANY DISCUSSION OR DECISION WHERE THE CONFLICT HAS A BEARING. FORM 990, PART VI, SECTION B, LINE 15 A BOARD OF DIRECTORS COMPENSATION COMMITTEE MEETS AND REVIEWS EXECUTIVE COMPENSATION ANNUALLY. PERIODICALLY, THE COMMITTEE REQUESTS A COMPENSATION ANALYSIS TO DETERMINE IF EMPLOYEE COMPENSATION HAS REMAINED WITHIN MARKET RANGE OR IF ADJUSTMENTS ARE REQUIRED. THIS INFORMATION IS THEN USED AS A BASIS FOR THE COMPENSATION COMMITTEE'S RECOMMENDATION TO THE BOARD OF DIRECTORS. AN OVERALL SALARY PROGRAM FOR EMPLOYEES MUST BE APPROVED BY THE BOARD OF DIRECTORS COMPENSATION COMMITTEE BEFORE IMPLEMENTATION. ALL EMPLOYEE SALARY INCREASES MUST BE APPROVED BY THE PRESIDENT/COO. FORM 990, PART VI, SECTION C, LINE 19 ARTICLES OF INCORPORATION CAN BE FOUND ON THE ARIZONA CORPORATION COMMISSION WEBSITE. THE CONFLICT OF INTEREST POLICY AND THE FINANCIAL STATEMENTS (VIA THE ANNUAL REPORT) ARE POSTED ON THE INSTITUTE'S WEBSITE. FORM 990, PART IX, LINE 11G RESEARCH SUPPORT SERVICES: PROGRAM SERVICE EXPENSES 1,481,156. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,481,156. CONSULTING: PROGRAM SERVICE EXPENSES 1,166,698. MANAGEMENT AND GENERAL EXPENSES 415,577. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,582,275. OTHER PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 400,050. MANAGEMENT AND GENERAL EXPENSES 287,427. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 687,477. CRITICAL PATH INSTITUTE LTD 33 SIR JOHN ROGERSONS QUAY DUBLIN EI EDUCATION AND RESEARCH IN EUROPE TO ACCELERATE DEVELOPMENT OF NEW THERAPIES EI CRITICAL PATH INSTITUTE C 321053 1.00000 1 CRITICAL PATH INSTITUTE STICHTING 1083 HN AMSTERDAM AMSTERDAM NL EDUCATION AND RESEARCH IN EUROPE TO ACCELERATE DEVELOPMENT OF NEW THERAPIES NL CRITICAL PATH INSTITUTE T 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 CRITICAL PATH INSTITUTE LTD D 156320 END OF YEAR BALANCE