2022-05-13T10:02:44-05:00 2021-12-31 871353108 EISNER ADVISORY GROUP LLC 130 NORTH 18TH STREET SUITE 3000 PHILADELPHIA PA 191032757 990 2021-01-01 460886344 TRANSCELERATE BIOPHARMA INC TRAN 4845391230 300 CONSHOHOCKEN STATE ROAD 420 WEST CONSHOHOCKEN PA 19428 DALVIR GILL PHD CEO 4845391230 2022-05-04 1 DALVIR GILL PHD 999009999 HELEN M MARTIN P01330899 2158818800 3 AAL1 IAL1 2021 2022-09-23 18:48:47Z X DALVIR GILL PHD 300 CONSHOHOCKEN STATE ROAD 420 WEST CONSHOHOCKEN PA 19428 31090660 0 X WWW.TRANSCELERATEBIOPHARMAINC.COM X 2012 DE IMPROVE THE HEALTH OF PEOPLE IN THE WORLD BY ENHANCING THE R&D OF INNOVATIVE THERAPIES.TRANSCELERATE BIOPHARMA INC. IS A NON-PROFIT ORGANIZATION DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES. THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 20 19 26 0 0 0 0 0 31908666 31089166 66228 1494 0 0 31974894 31090660 0 0 0 0 7623942 7917435 0 0 0 20484023 25262906 28107965 33180341 3866929 -2089681 49374410 50373384 36650129 39738784 12724281 10634600 X TRANSCELERATE BIOPHARMA INC. IS DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES.THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES. TRANSCELERATE EVOLVED FROM CONVERSATIONS AT VARIOUS FORUMS FOR EXECUTIVE R&D LEADERSHIP TO DISCUSS CURRENT ISSUES FACING THE INDUSTRY, AND EXAMINE SOLUTIONS FOR ADDRESSING COMMON CHALLENGES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS. 0 0 24885823 31089166 OUTLINED BELOW ARE A FEW OF THE NUMEROUS YEAR-END ACHIEVEMENTS THROUGHOUT THE TRANSCELERATE PORTFOLIO.THE DIGITAL DATA FLOW INITIATIVE COMMENCED DEVELOPMENT ON A REFERENCE IMPLEMENTATION OF A STUDY DEFINITIONS REPOSITORY. THE STUDY DEFINITIONS REPOSITORY IS A NOVEL CENTRAL COMPONENT AIMED AT FACILITATING THE EXCHANGE OF STRUCTURED STUDY DEFINITIONS ACROSS CLINICAL SYSTEMS USING TECHNICAL AND DATA STANDARDS.THE STRATEGIC PRIORITY, IMPROVE THE PATIENT EXPERIENCE, LAUNCHED THE DIVERSITY OF PARTICIPANTS IN CLINICAL TRIALS INITIATIVE TO HELP EQUIP SPONSORS AND ECOSYSTEM STAKEHOLDERS WITH THE ACTIONABLE TOOLS AND RESOURCES NEEDED TO IMPROVE OUTCOMES FOR DIVERSIFICATION OF PARTICIPANTS IN CLINICAL TRIALS. AS PART OF THE FIRST PHASE OF THE INITIATIVE, THE FOLLOWING EFFORTS ARE UNDERWAY: DEVELOPING A CLINICAL RESEARCH DIVERSITY COLLABORATION HUB, RACE AND ETHNICITY ENROLLMENT DATA BENCHMARKING, AND BEST PRACTICES FOR SPONSORS AND CLINICAL TRIAL SITES. THIS INITIATIVE HOSTED TWO DIVERSITY ROUNDTABLE EVENTS. TRANSCELERATE'S MODERNIZING CLINICAL TRIAL CONDUCT (MCTC) INITIATIVE, IN COLLABORATION WITH THE RISK BASED MONITORING (RBM) INITIATIVE, RELEASED A PUBLICLY-AVAILABLE REPORT SHARING VOLUNTARY SURVEY DATA RELATED TO RBM ACTIVITIES PRE-COVID-19: "RESULTS OF RBM SDV/ SDR SURVEY: 2020 PRE-COVID-19 PANDEMIC PRACTICES." THIS REPORT SERVES AS THE FINAL DELIVERABLE OF THE RECENTLY COMPLETED RBM INITIATIVE. THIS INITIATIVE ALSO RELEASED AN OPERATIONAL COMPLEXITY ASSESSMENT TOOL WHICH IS AN INTERACTIVE TOOL THAT ASSESSES THE COMPLEXITY OR LACK OF COMPLEXITY OF IMPLEMENTING SELECTED MODERN SOLUTIONS IN A CLINICAL TRIAL.THE PATIENT EXPERIENCE INITIATIVE UPDATED TWO KEY SOLUTIONS, THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) USER GUIDE AND THE P-PET RESOURCE GUIDE, TO INCLUDE NEW CONSIDERATIONS RELATED TO CAREGIVERS IN CLINICAL TRIALS AS WELL AS BEST PRACTICES FOR ENGAGING PATIENTS AND CAREGIVERS IN A VIRTUAL ENVIRONMENT. THE INITIATIVE ALSO RELEASED JAPANESE TRANSLATIONS OF THE P-PET, USER GUIDE VERSION 1.5, AND RESOURCE GUIDE VERSION 1.5, AND MORE THAN 15 DIFFERENT TRANSLATIONS OF THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ).THE PATIENT TECHNOLOGY INITIATIVE UPDATED ITS PATIENTS CONSIDERATIONS GUIDE AND PATIENT TECHNOLOGY SITE FEEDBACK QUESTIONNAIRE (PTSFQ) TO INCLUDE CONSIDERATIONS AROUND DECENTRALIZED TRIALS AND VIRTUAL ENVIRONMENTS AND PUBLISHED ITS NOVEL DIGITAL ENDPOINTS PAPER "DEVELOPING A NOVEL MEASUREMENT OF SLEEP IN RHEUMATOID ARTHRITIS: STUDY PROPOSAL FOR APPROACH AND CONSIDERATIONS."TRANSCELERATE'S STRATEGIC PRIORITY, IMPROVE THE SITE EXPERIENCE, UPDATED AND RELEASED A NEW GOOD CLINICAL PRACTICE (GCP) MUTUAL RECOGNITION WEBSITE TO IMPROVE USER EXPERIENCE AS PART OF THE SITE QUALIFICATION & TRAINING (SQT) INITIATIVE. AS PART OF THIS UPGRADE, THERE IS NOW INTEGRATION WITH THE SHARED INVESTIGATOR PLATFORM (SIP). SQT ALSO CREATED AN INFORMATIONAL VIDEO ON ITS GCP MUTUAL RECOGNITION PROGRAM.THE MODERNIZATION OF STATISTICAL ANALYTICS INITIATIVE LAUNCHED ITS FOUNDATIONAL FRAMEWORK TO EXPLORE A PRODUCT-AGNOSTIC APPROACH TO BUILD TRUSTWORTHINESS OF USING MODERN STATISTICAL SOFTWARE TOOLS FOR REGULATORY DECISION-MAKING. THE FRAMEWORK INCLUDES PRINCIPLES THAT CAN BE USED BY REGULATORS AND OTHERS ACROSS THE INDUSTRY TO ESTABLISH A HIGH LEVEL OF ACCURACY, TRACEABILITY, AND REPRODUCIBILITY WITH REGARD TO REGULATORY SUBMISSIONS. ACCOMPANYING THIS FRAMEWORK IS AN INFOGRAPHIC AND CASE FOR ADOPTION.THE PROTOCOL DEVIATIONS INITIATIVE PUBLISHED A MANUSCRIPT ENTITLED, "PROTOCOL DEVIATIONS: A HOLISTIC APPROACH FROM DEFINING TO REPORTING." IN ADDITION TO THE PAPER, THE TEAM MADE UPDATES TO ITS PROTOCOL DEVIATION DECISION TREE AND PROTOCOL DEVIATION PROCESS GUIDE.THE DATA MONITORING COMMITTEE (DMC) INITIATIVE SUCCESSFULLY TRANSITIONED ITS EXISTING MATERIALS TO THE SOCIETY FOR CLINICAL TRIALS (SCT). USING TRANSCELERATE-DEVELOPED SOLUTIONS INCLUDING A DMC REGISTRY PROTOTYPE EBOOK, PROOF OF CONCEPT VIDEO, AND DMC APPRENTICESHIP MODEL OVERVIEW, SCT LAUNCHED ITS OWN DMC INITIATIVE BRINGING THE CONCEPT TO LIFE. THE SCT DMC INITIATIVE OFFERS ITS MEMBERS TRAINING, A REGISTRY FOR INDIVIDUALS WHO ARE INTERESTED IN SERVING AS DMC MEMBERS, AND MENTORING OPPORTUNITIES. THIS INITIATIVE IS NOW COMPLETE WITH NO NEW DELIVERABLES OR UPDATES PLANNED.THE INTERPRETATION OF CLINICAL GUIDANCES AND REGULATIONS INITIATIVE PUBLISHED ITS FRAMEWORK PAPER, "HISTORICAL BENCHMARKS FOR QUALITY TOLERANCE LIMITS PARAMETERS IN CLINICAL TRIALS."THE CLINICAL CONTENT & REUSE (CC&R) INITIATIVE RELEASED JAPANESE TRANSLATIONS OF THE COMMON PROTOCOL TEMPLATE (CPT) AND PATIENT LIBRARY. CC&R ALSO RELEASED ITS 2021 UPDATE, WHICH INCLUDES CLINICAL TEMPLATE SUITE ENHANCEMENTS FOR REGISTRY AUTOMATION AND MODEL CONTENT QUALITY, INCORPORATION OF PANDEMIC-RELATED LEARNING, ESTIMAND CLARIFICATIONS, AND ETEMPLATES TECHNICAL FRAMEWORK UPDATES, AMONG OTHER ITEMS.THE ESOURCE INITIATIVE RELEASED THE ESOURCE INFORMATICS CONTINUUM AND REFERENCE GUIDE FOR CLINICAL RESEARCH SITES, WHICH PROVIDES INFORMATION ON CLINICAL RESEARCH INFORMATICS, THE BASICS OF INFORMATICS, AND POSSIBLE RESOURCES TO EXPAND CAPABILITIES AROUND INTEROPERABILITY AND DATA EXCHANGE FOR CLINICAL SITES. IT IS ACCOMPANIED BY THE ESOURCE INFORMATICS CONTINUUM. THIS INITIATIVE CONTINUED PARTICIPATION AND LEADERSHIP IN VULCAN, AN HL7 FHIR ACCELERATOR. DATACELERATE UNDERWENT INFRASTRUCTURE ENHANCEMENTS ACROSS THE PLATFORM TO BETTER FACILITATE DATA SHARING.THE HISTORICAL TRIAL DATA SHARING INITIATIVE DEVELOPED AN ADOPTION FRAMEWORK: 5 ENABLERS OF DATA SHARING. THIS FRAMEWORK DETAILS THE KEY PRINCIPLES THAT CAN HELP PARTICIPANTS IN TRANSCELERATE DEVELOP DATA SHARING PROCESSES AND PROCEDURES.THE PRIVACY METHODOLOGY FOR DATA SHARING INITIATIVE DEVELOPED ITS FIRST-EVER OVERVIEW OF ITS BENEFITS AND GOALS.TRANSCELERATE'S INTELLIGENT AUTOMATION OPPORTUNITIES (IAO) IN PHARMACOVIGILANCE INITIATIVE PUBLISHED THE PAPER "VALIDATING INTELLIGENT AUTOMATION SYSTEMS IN PHARMACOVIGILANCE: INSIGHTS FROM GOOD MANUFACTURING PRACTICES." THE IAO INITIATIVE ALSO HELD KEY HEALTH AUTHORITIES MEETINGS WITH THE FDA, EMA, AND HEALTH CANADA TO DISCUSS ITS PROGRESS AND VALIDATION PROPOSAL. IN ADDITION, THE TEAM CONTINUED ITS COLLABORATION WITH MHRA DURING TWO SESSIONS AT DIA EUROPE. THE INTERPRETATION OF PHARMACOVIGILANCE GUIDANCES & REGULATIONS INITIATIVE COMMENCED WORK ON ITS NEWEST TOPIC CONCERNING THE MULTIPLE NEW REGULATORY GUIDELINES GOVERNING THE USE OF MEDICINES IN PREGNANCY AND BREASTFEEDING. THE PHARMACOVIGILANCE AGREEMENTS OPTIMIZATION (PVAO) INITIATIVE TEAM LAUNCHED ITS SOLUTIONS PAGE, AN INTERACTIVE PROCESS MAP, AND A GLOSSARY. THE VALUE OF SAFETY INFORMATION DATA SOURCES (VSIDS) INITIATIVE RELEASED THE INFOGRAPHIC "IDENTIFYING THE VALUE OF INFORMATION DATA SOURCES TO IMPROVE PATIENT SAFETY."BIOCELERATE'S COMMON TEMPLATES FOR NONCLINICAL STUDIES PRESENTED THE POSTER "SUPPORTING EFFICIENCIES IN NONCLINICAL TOXICOLOGY STUDIES THROUGH COMMON TEMPLATES" AT THE SOCIETY OF TOXICOLOGY ANNUAL MEETING AND PRESENTED THE POSTER "SUPPORTING EFFICIENCIES IN NONCLINICAL TOXICOLOGY STUDIES THROUGH PROTOCOL AND REPORT TEMPLATES: PROGRESS TOWARDS ADOPTION" AT THE AMERICAN COLLEGE OF TOXICOLOGY ANNUAL MEETING. THIS INITIATIVE ALSO COMPLETED ITS INTERNAL PHASE 1 PILOT WITH VOLUNTARY PARTICIPATION FROM ALL BIOCELERATE COMPANIES TO ASSESS THE VALUE AND FUNCTION OF ITS TEMPLATES COMPARED TO TEMPLATES USED BY PARTICIPATING COMPANIES.THE SEND HARMONIZATION FOR CROSS-STUDY ANALYSIS INITIATIVE EXTENDED ITS PUBLIC PRIVATE PARTNERSHIP (PPP) WITH THE U.S. FDA'S CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF COMPUTATIONAL SCIENCE TO CONTINUE TO CREATE RESOURCES AND TOOLS TO AID SEND IMPLEMENTATION FOR CROSS-STUDY ANALYSIS AND PUBLISHED ITS MANUSCRIPT "LEVERAGING THE VALUE OF CDISC SEND DATASETS FOR CROSS-STUDY ANALYSIS: INCIDENCE OF MICROSCOPIC FINDINGS IN CONTROL ANIMALS." AS PART OF A COLLABORATION WITH PHUSE, A WHITE PAPER "RECOMMENDATIONS FOR POPULATING CONTROL TYPE (TCNTRL) WITH CDISC SEND CONTROLLED TERMINOLOGY" WAS PUBLISHED. THE SEND INITIATIVE ALSO HOSTED THE "COLLABORATIVELY CRACKING THE SEND CODE: UNLOCKING THE POTENTIAL VALUE OF STANDARDIZED TOXICOLOGY STUDY DATA" WORKSHOP AT THE AMERICAN COLLEGE OF TOXICOLOGY ANNUAL MEETING.TOXICOLOGY & BACKGROUND CONTROL DATA SHARING SIGNIFICANTLY INCREASED THE NUMBER OF SEND FORMAT TOXICOLOGY AND BACKGROUND AND CONTROL STUDIES IN THE TOXICOLOGY DATA SHARING DATABASE AND LAUNCHED THE DATACELERATE SEARCH ENHANCEMENT RELEASE FOR THE TOXICOLOGY AND BACKGROUND CONTROL MODULES TO SIGNIFICANTLY ENHANCE THE USABILITY AND SEARCHABILITY OF THE TDS DATABASE. 24885823 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 24 0 1 26 1 0 0 0 0 0 0 1 0 X 20 19 0 0 0 0 1 1 0 1 1 0 0 1 1 1 1 1 0 1 1 0 X ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 4845391235 1001 CONSHOHOCKEN STATE ROAD STE WEST CONSHOHOCKEN PA 19428 ROD MACKENZIE CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 KATHRYN OWEN VICE CHAIR OF BOARD OF DIRECTORS 0.50 X 0 0 0 ROY BAYNES BOARD MEMBER 0.50 X 0 0 0 DIETMAR BERGER BOARD MEMBER 0.50 X 0 0 0 CHRIS CORSICO BOARD MEMBER 0.50 X 0 0 0 MARTIN HOLST LANGE BOARD MEMBER 0.50 X 0 0 0 ROB LENZ BOARD MEMBER (EFF 03/26/21) 0.50 X 0 0 0 IRIS LOEW-FRIEDRICH BOARD MEMBER 0.50 X 0 0 0 CRISTIAN MASSACESI BOARD MEMBER (EFF 09/23/21) 0.50 X 0 0 0 ROBERT METCALF BOARD MEMBER 0.50 X 0 0 0 JOHN OIDTMAN BOARD MEMBER 0.50 X 0 0 0 STUART POULTON BOARD MEMBER (EFF 06/21/21) 0.50 X 0 0 0 STEFFEN ROELLINGER BOARD MEMBER 0.50 X 0 0 0 MICHELLE ROHRER BOARD MEMBER 0.50 X 0 0 0 PETER RONCO BOARD MEMBER 0.50 X 0 0 0 MEHDI SHAHIDI BOARD MEMBER 0.50 X 0 0 0 BADHRI SRINIVASAN BOARD MEMBER 0.50 X 0 0 0 TAKUKO YAMADA-SAWADA BOARD MEMBER 0.50 X 0 0 0 BERNHARDT G ZEIHER BOARD MEMBER 0.50 X 0 0 0 NEIL GALLAGHER BOARD MEMBER (THRU 06/21/21) 0.50 X 0 0 0 ELLIOTT LEVY BOARD MEMBER (THRU 03/26/21) 0.50 X 0 0 0 ANN TAYLOR BOARD MEMBER (THRU 09/23/21) 0.50 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 40.00 X X 1929245 0 80918 ROBERT BAKER CORPORATE SECRETARY 0.50 X 0 0 0 ANDREW LEE TREASURER 0.50 X 0 0 0 JANICE CHANG CHIEF OPERATING OFFICER 40.00 X 770503 0 41169 JENNIFER A BURGESS VP GLOBAL ENGAGEMENT AND COMM. 40.00 X 394547 0 50265 CARA L RINALDI EXEC DIRECTOR OF PORTFOLIO MGMT 40.00 X 332279 0 55432 JENEEN DONADEO SENIOR DIRECTOR OF PORTFOLIO MGMT 40.00 X 315440 0 36273 ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 40.00 X 280583 0 46240 PATRICE WRIGHT HEALTH AUTHORITY ENGAGEMENT DIRECTOR 40.00 X 259757 0 28363 4282354 0 338660 20 0 1 0 PA CONSULTING GROUP INC 10 BRESSENDEN PLACE LONDON UK CONSULTING SERVICES 7281210 ACCENTURE LLP 161 N CLARK STREET CHICAGO IL 60601 CONSULTING & IT SERVICES 6161651 KILPATRICK TOWNSEND 601 14TH STREET NW SUITE 900 WASHINGTON DC 20005 LEGAL SERVICES 2584122 ARTEMIS FACTOR LLC 314 CARLYLE ROAD WEST CHESTER PA 19382 CONSULTING SERVICES 1377476 FLUID EDGE 10 MYSTIC LANE MALVERN PA 19355 CONSULTING SERVICES 1343651 20 MEMBERSHIP DUES 541900 31089166 31089166 31089166 1494 1494 31090660 31089166 0 1494 X 2821835 2821835 4068180 2260192 1807988 166868 66699 100169 521749 203718 318031 338803 137693 201110 2575346 1739668 835678 94654 94654 13597574 12878856 718718 16451 8764 7687 158129 996 157133 7877110 7586027 291083 221196 221196 21646 231 21415 10415 2979 7436 234177 234177 RECRUITING 257058 257058 EXCESS COMPENSATION TAX 195141 195141 BOOKS, SUBSCRIPTIONS, R 2317 2317 DUES 1692 1692 33180341 24885823 8294518 0 18363859 17656028 1588161 0 29239481 32595000 171062 83526 0 0 0 0 11847 38830 49374410 50373384 5560963 6206784 31089166 33532000 36650129 39738784 X 12724281 10634600 12724281 10634600 49374410 50373384 -2089681 0 X 0 0 0 0 1 0 X 0 0 0 DALVIR GILL CHIEF EXECUTIVE OFFICER 663941 0 1265304 0 0 0 11600 0 69318 0 2010163 0 0 0 JANICE CHANG CHIEF OPERATING OFFICER 517870 0 252633 0 0 0 11600 0 29569 0 811672 0 0 0 JENNIFER A BURGESS VP GLOBAL ENGAGEMENT AND COMM. 303191 0 91356 0 0 0 11600 0 38665 0 444812 0 0 0 CARA L RINALDI EXEC DIRECTOR OF PORTFOLIO MGMT 246815 0 85464 0 0 0 6723 0 48709 0 387711 0 0 0 JENEEN DONADEO SENIOR DIRECTOR OF PORTFOLIO MGMT 243055 0 72385 0 0 0 11153 0 25120 0 351713 0 0 0 ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 216029 0 64554 0 0 0 10030 0 36210 0 326823 0 0 0 PATRICE WRIGHT HEALTH AUTHORITY ENGAGEMENT DIRECTOR 208257 0 51500 0 0 0 6336 0 22027 0 288120 0 0 0 PART I, LINE 3 THE BOARD CHAIR, WITH INPUT FROM OTHER DIRECTORS OR A SUBCOMMITTEE OF THE BOARD, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE. FORM 990, PART VI, SECTION A, LINE 6 THE MEMBERS OF THE CORPORATION CONSIST OF SUCH FIRMS AND CORPORATIONS THAT ARE APPROVED FOR MEMBERSHIP FROM TIME TO TIME BY THE BOARD OF DIRECTORS OR ITS DESIGNEES IN ACCORDANCE WITH THE POLICIES AND PROCEDURES OF THE CORPORATION. THE CORPORATION HAS THE FOLLOWING CATEGORIES OF MEMBERS: A. TIER I MEMBERS - TO BE ELIGIBLE FOR TIER I MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT IN EXCESS OF $2.5 BILLION. ELIGIBILITY FOR TIER I MEMBERSHIP IS ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. THE INITIAL TIER I MEMBERS ARE FURTHER DEFINED AS THE "CHARTER MEMBERS." B. TIER II MEMBERS - TO BE ELIGIBLE FOR TIER II MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $2.5 BILLION BUT MORE THAN $100 MILLION. ELIGIBILITY FOR TIER II MEMBERSHIP WILL BE ESTABLISHED BASED UPON A COMPANY'S PUBLICALLY AVAILABLE RESEARCH AND DEVELOPMENT EXPENDITURES OVER THE THREE (3) YEAR PERIOD PRECEDING THE DATE THE COMPANY APPLIES TO JOIN THE CORPORATION. C. ASSOCIATE MEMBERS - TO BE ELIGIBLE FOR ASSOCIATE MEMBERSHIP, A FIRM OR CORPORATION MUST BE A PHARMACEUTICAL OR BIOTECHNOLOGY COMPANY WITH AN ANNUAL BUDGET FOR RESEARCH AND DEVELOPMENT THAT IS LESS THAN $100 MILLION. FORM 990, PART VI, SECTION A, LINE 7A THE BOARD OF DIRECTORS SHALL BE COMPRISED OF UP TO TWENTY-TWO (22) DIRECTORS; PROVIDED THAT: (I) TEN (10) SEATS ARE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE CHARTER MEMBERS; (II) UP TO FOUR (4) ADDITIONAL SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER I MEMBERS WHO ARE NOT CHARTER MEMBERS; (III) UP TO SIX (6) SEATS SHALL BE FILLED BY DIRECTORS WHO ARE REPRESENTATIVES OF THE TIER II MEMBERS; (IV) ONE (1) SEAT SHALL BE FILLED BY A DIRECTOR WHO IS A REPRESENTATIVE OF THE ASSOCIATE MEMBERS; AND (V) ONE (1) SEAT SHALL BE FILLED BY THE CHIEF EXECUTIVE OFFICER OF THE CORPORATION. THE CORPORATION'S BYLAWS STATE THAT DIRECTORS SHALL BE ELECTED OR APPOINTED, AS APPLICABLE, ANNUALLY AT THE ANNUAL MEETING OF MEMBERS AND SHALL SERVE UNTIL THE FOLLOWING ANNUAL MEETING OF MEMBERS AND UNTIL THEIR SUCCESSORS ARE ELECTED OR APPOINTED, AS APPLICABLE, AND QUALIFIED. EACH CHARTER MEMBER SHALL HAVE THE RIGHT TO APPOINT A REPRESENTATIVE OF THE CHARTER MEMBER TO SERVE AS A CHARTER MEMBER DIRECTOR. TIER I AT-LARGE DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER I MEMBERS, WHICH INCLUDE THE CHARTER MEMBERS. TIER II DIRECTORS SHALL BE ELECTED BY A PLURALITY VOTE OF THE TIER II MEMBERS. ANY ASSOCIATE MEMBER DIRECTOR SHALL BE ELECTED BY A PLURALITY VOTE OF THE ASSOCIATE MEMBERS. THE CEO DIRECTOR SHALL SERVE EX-OFFICIO, FOR SO LONG AS HE OR SHE SHALL HOLD THE OFFICE OF CHIEF EXECUTIVE OFFICER. TRANSCELERATE DOES NOT PRESENTLY HAVE ANY ASSOICATE MEMBERS THEREFORE, THE ASSOICATE MEMBER BOARD SEAT IS CURRENTLY VACANT. EACH TIER I MEMBER SHALL BE ENTITLED TO THREE (3) VOTES AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER 1 MEMBERS ARE ENTITLED TO VOTE. EACH TIER II MEMBER SHALL BE ENTITLED TO ONE (1) VOTE AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER II MEMBERS ARE ENTITLED TO VOTE. ASSOCIATE MEMBERS SHALL BE ENTITLED TO NOTICE OF AND TO ATTEND MEETINGS OF THE MEMBERS BUT SHALL NOT BE ENTITLED TO VOTE AT SUCH MEETINGS, PROVIDED HOWEVER, ASSOCIATE MEMBERS SHALL HAVE THE RIGHT TO CAST ONE (1) VOTE EACH WITH RESPECT TO THE ELECTION OF THE NOMINEE TO FILL THE ASSOCIATE MEMBER BOARD POSITION. NOTWITHSTANDING THE ABOVE, IN ORDER TO BE ELIGIBLE TO VOTE, A MEMBER MUST BE IN GOOD STANDING AND ITS DUES AND ASSESSMENTS PAID IN FULL. FORM 990, PART VI, SECTION B, LINE 11B THE FINANCE COMMITTEE AND MANAGEMENT REVIEW AND APPROVE THE FORM 990. THE FORM IS THEN DISTRIBUTED TO ALL MEMBERS OF THE BOARD FOR THEIR REVIEW BEFORE FILING WITH THE INTERNAL REVENUE SERVICE. FORM 990, PART VI, SECTION B, LINE 12C EACH DIRECTOR AND OFFICER OF THE CORPORATION IS REQUIRED TO ANNUALLY ACKNOWLEDGE THE CONFLICT OF INTEREST POLICY, AFFIRMING THAT SUCH PERSON HAS RECEIVED, READ AND UNDERSTANDS, AND AGREED TO COMPLY WITH THE CONFLICT OF INTEREST POLICY. FORM 990, PART VI, SECTION B, LINE 15 THE BOARD CHAIR, WITH INPUT FROM OTHER DIRECTORS OR A SUBCOMMITTEE OF THE BOARD, ANNUALLY REVIEWS AND APPROVES THE CEO'S COMPENSATION PACKAGE. THE CEO APPROVES THE COMPENSATION FOR THE CHIEF OPERATING OFFICER, AND ALL OTHER KEY EMPLOYEES. FORM 990, PART VI, SECTION C, LINE 19 THE ORGANIZATION'S GOVERNING DOCUMENTS, FINANCIAL STATEMENTS, AND CONFLICT OF INTEREST POLICY AND OTHER CORPORATE POLICIES ARE AVAILABLE UPON REQUEST. FORM 990, PART IX, LINE 11G PROJECT MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 8,414,185. MANAGEMENT AND GENERAL EXPENSES 15,493. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 8,429,678. EXTERNAL CONTRACTOR SUPPORT: PROGRAM SERVICE EXPENSES 1,725,587. MANAGEMENT AND GENERAL EXPENSES 56,078. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,781,665. COMMUNICATIONS FEES: PROGRAM SERVICE EXPENSES 188,701. MANAGEMENT AND GENERAL EXPENSES 647,147. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 835,848. CHANGE MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 2,550,383. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 2,550,383. BIOCELERATE LLC 1001 CONSHOHOCKEN STATE ROAD STE 1- WEST CONSHOHOCKEN PA 19428 475492971 TO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH. DE 1459166 3020407 TRANSCELERATE BIOPHARMA INC