2023-05-11T10:44:59-05:00 2022-12-31 871353108 EISNER ADVISORY GROUP LLC 130 NORTH 18TH STREET SUITE 3000 PHILADELPHIA PA 191032757 990 2022-01-01 460886344 TRANSCELERATE BIOPHARMA INC TRAN 4845391230 300 CONSHOHOCKEN STATE ROAD 420 WEST CONSHOHOCKEN PA 19428 JANICE CHANG CEO 4845391230 2023-05-09 1 JANICE CHANG 999009999 0 HELEN M MARTIN P01330899 2158818800 2 AAL1 IAL1 2022 2023-04-26 12:10:37Z JANICE CHANG 300 CONSHOHOCKEN STATE ROAD 420 WEST CONSHOHOCKEN PA 19428 33600302 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 25 29 0 0 0 0 31089166 33532000 1494 68302 0 0 31090660 33600302 0 0 0 0 7917435 9009562 0 0 0 25262906 25252810 33180341 34262372 -2089681 -662070 50373384 48482660 39738784 38508812 10634600 9973848 X TRANSCELERATE BIOPHARMA'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL RESEARCH AND DEVELOPMENT COMMUNITY TO IDENTIFY, PRIORITIZE, DESIGN, AND FACILITATE THE 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. 0 0 23814572 33532000 IN 2022, TRANSCELERATE DELIVERED THE FOLLOWING ACCOMPLISHMENTS:THE DIGITAL DATA FLOW (DDF) INITIATIVE, COLLABORATED WITH MULTIPLE INDUSTRY PARTNERS, TO RELEASE FOUNDATIONAL STANDARDS THROUGH THE CLINICAL DATA STANDARDS CONSORTIUM AND A MINIMUM VIABLE PRODUCT (MVP) FOR A STUDY DEFINITIONS REPOSITORY (SDR) REFERENCE IMPLEMENTATION, DESIGNED TO ALLOW FOR THE FLOW OF DIGITAL PROTOCOL DATA ACROSS DISPARATE SYSTEMS. TO FURTHER SUPPORT THIS LAUNCH, THE DDF TEAM HOSTED A MONTH-LONG VIRTUAL CONNECTATHON WHERE ORGANIZATIONS WERE ABLE TO DEMONSTRATE CONNECTIVITY OF THEIR SOLUTIONS TO THE SDR, AND SHOWCASE INNOVATIVE USE CASES. TRANSCELERATE'S DIVERSITY OF PARTICIPANTS IN CLINICAL TRIALS INITIATIVE RELEASED A REFERENCE LIST OF KEY SOLUTIONS TO SUPPORT DIVERSIFYING PATIENT POPULATIONS IN CLINICAL TRIALS: A REFERENCE TABLE AND VISUAL LANDSCAPE OF AVAILABLE RESOURCES; A U.S. REGULATORY LANDSCAPE: DIVERSITY IN CLINICAL TRIALS DESIGNED TO HELP IDENTIFY KEY U.S. LEGISLATION AND U.S. FDA POLICY, REGULATION, AND GUIDANCE, AS WELL AS REGULATORY PRECEDENT TO CONSIDER WHEN WORKING TO UNDERSTAND AND IMPROVE THE DIVERSITY AND INCLUSION (D&I) OF ADULT PATIENTS IN CLINICAL TRIALS, FOCUSING ON THE INCLUSION OF RACIAL AND ETHNIC MINORITIES; A SPONSOR TOOLKIT PORTFOLIO AND PROGRAM-LEVEL CONSIDERATIONS FOR DIVERSITY, EQUITY AND INCLUSION OF PARTICIPANTS IN CLINICAL TRIALS (DEICT); THE DIVERSITY COMMUNITY-BASED SITE ENGAGEMENT AND CAPACITY BUILDING SOLUTION PROVIDES AN AGGREGATED COLLECTION OF INSIGHTS AND PERSPECTIVES FROM THE ATTENDING ORGANIZATIONS OF A JUNE 2022 ROUNDTABLE EVENT; THE SPONSOR TOOLKIT SITE ENGAGEMENT AND CAPACITY BUILDING CONSIDERATIONS FOR DIVERSITY, EQUITY AND INCLUSION OF PARTICIPANTS IN CLINICAL TRIALS (DEICT) SOLUTION COMPRISES A SET OF MITIGATION CONSIDERATIONS DESIGNED TO SUPPORT EFFORTS TO SUSTAINABLY PARTNER WITH SITES TO ENABLE THE ENROLLMENT AND RETENTION OF UNDERREPRESENTED PATIENT POPULATIONS IN CLINICAL TRIALS. THE MODERNIZING CLINICAL TRIAL CONDUCT (MCTC) INITIATIVE RELEASED THE CLINICAL TRIALS IN 2031 AND BEYOND REPORT, WHICH CAN HELP THE ECOSYSTEM UNDERSTAND SOME OF THE DIVERSE DRIVERS THAT INFLUENCE THEFUTURE OF CLINICAL TRIALS. THE MCTC INITIATIVE ALSO RELEASED A PARTICIPANT DATA RETURN RESOURCE PACK, WHICH PROVIDES ACCESS TO A CONSOLIDATED SET OF RESOURCES FROM WITHIN THE CLINICAL RESEARCH ECOSYSTEM THAT CAN ASSIST WITH RETURNING INDIVIDUAL DATA GLOBALLY.THE PATIENT EXPERIENCE (PE) INITIATIVE RELEASED A STREAMLINED VERSION OF THE PATIENT PROTOCOL ENGAGEMENT TOOLKIT (P-PET) RESOURCE GUIDE THAT PROVIDES SAMPLE QUESTIONS FOR CONSIDERATION DURING AN ENGAGEMENT WITH PATIENTS AND CAREGIVERS. AN UPDATED VERSION OF THE P-PET USER GUIDE PROVIDES EXAMPLE CASE STUDIES AND WAYS THAT HELP SUPPORT SPONSORS UNDERSTAND HOW TO IMPLEMENT THE P-PET WITHIN THEIR CLINICAL STUDIES. ACCOMPANYING THESE TWO RELEASES IS A QUICK START VIDEO WITH JAPANESE SUBTITLES TO SUPPORT THE ADOPTION OF THE P-PET TOOLKIT. THE TEAM ALSO RELEASED VERSION 2.0 OF THE STUDY PARTICIPANT FEEDBACK QUESTIONNAIRE (SPFQ) SOCIALIZATION PRESENTATION AND THE SPFQ IMPLEMENTATION USER GUIDE. A SPFQ QUESTION BANK ADDENDUM PROVIDES NEW AND REPLACEMENT QUESTIONS TO BE UTILIZED IN CONJUNCTION WITH THE SPFQ.SITE QUALIFICATION & TRAINING (SQT) GOOD CLINICAL PRACTICE MUTUAL RECOGNITION TRAINING DATABASE NOW HAS OVER 1,900 SELF-ATTESTED TRAINING COURSES BY OVER 600 UNIQUE TRAINING PROVIDERS. THE SOCIETY FOR CLINICAL RESEARCH SITES (SCRS) LED A COLLABORATIVE GOVERNANCE EXERCISE USING SITE FEEDBACK TO SUGGEST IMPROVEMENTS FOR TRANSCELERATE'S DELEGATION OF RESPONSIBILITIES LOG, GUIDANCE, AND SUMMARY OF CHANGES TO INCORPORATE SITES' TOP CONCERNS. VERSION 3 OF THIS LOG, ALONG WITH A SUMMARY OF CHANGES DOCUMENT, WAS RELEASED ON SCRS'S WEBSITE IN OCTOBER OF 2022; UPDATED AND RELEASED VERSION 4.0 FINANCIAL DISCLOSURE FORM (FIDS) FORM FOR USABILITY AND TECHNICAL IMPROVEMENTS.THE INTERPRETATION OF CLINICAL GUIDANCES & REGULATIONS (IGR) INITIATIVE FOCUSED ON CREATING SOLUTIONS TO HELP STAKEHOLDERS NAVIGATE THE NEW REVISIONS OF ICH E8 (2022) AND E6 (2023).THE MODERNIZATION OF STATISTICAL ANALYTICS (MOA) INITIATIVE RELEASED A CASE STUDY VIDEO LIBRARY. THESE SIX NARRATED CASE STUDY VIDEO PRESENTATIONS WILL HELP VIEWERS UNDERSTAND THE PRACTICAL USE OF THE MSA FRAMEWORK, AS THEY EXPLORE USING NON-TRADITIONAL ANALYTICAL SOFTWARE (INCLUDING OPEN-SOURCE SOFTWARE) IN HEALTH AUTHORITY REGULATORY SUBMISSIONS.THE CLINICAL CONTENT & REUSE INITIATIVE PUBLISHED THE CC&R PROCEDURES LIBRARY WHITE PAPER "EXAMINING POSSIBILITIES FOR A CONSISTENT PROCEDURES LIBRARY TO MODERNIZE CLINICAL TRIALS: A TRANSCELERATE POINT OF VIEW." CC&R RELEASED THE 2022 CLINICAL TEMPLATE SUITE (CTS) CONTENT ADDENDUM, PROVIDING A "LINE OF SIGHT" TO PLANNED CONTENT UPDATES THAT WILL ULTIMATELY BE CONSIDERED FOR FORMAL INCLUSION IN THE 2023 CTS RELEASE. CC&R UPDATED THE JAPANESE VERSION OF THE BASIC WORD EDITION CORE TEMPLATE AND THE PATIENT LIBRARY. ONE OF TRANSCELERATE'S NEWER INITIATIVES, REALWORLD DATA, LAUNCHED ITS FIRST DELIVERABLE, "PREPARING TO ENGAGE WITH HEALTH AUTHORITIES ON REAL WORLD EVIDENCE FOR MEDICINES: A TRANSCELERATE PERSPECTIVE," ALONG WITH AN ACCOMPANYING INFOGRAPHIC, ON ITS NEW WEBSITE.TRANSCELERATE'S CLINICAL DATA SHARING (CDS) TEAM UPGRADED THE HISTORICAL TRIAL DATA SHARING MODULE IN DATACELERATE. THE COMPARATOR NETWORK INITIATIVE COMPLETED A MAJOR PLATFORM UPGRADE TO HELP TO FACILITATE THE PURCHASE OF COMPARATOR PRODUCTS IN BOTH COMMERCIAL AND NON-COMMERCIAL PRESENTATIONS FOR USE IN CLINICAL TRIALS, AS WELL AS A WEB-BASED ORDERING SYSTEM THAT PARTICIPATING TRANSCELERATE MEMBERS CAN LEVERAGE TO EXECUTE COMPARATOR PRODUCT TRANSACTIONS AND EXCHANGE CRITICAL PRODUCT.THE PRIVACY METHODOLOGY FOR DATA SHARING INITIATIVE RELEASED ITS FIRST SOLUTION, THE EDUCATIONAL TOOLKIT FOR CLINICAL DATA REUSE.THE INTELLIGENT AUTOMATION OPPORTUNITIES IN PHARMACOVIGILANCE (IAO) INITIATIVE PUBLISHED TWO SEPARATE PAPERS IN THE PEER REVIEWED JOURNAL DRUG SAFETY. "INDUSTRY PERSPECTIVE ON ARTIFICIAL INTELLIGENCE MACHINE LEARNING IN PHARMACOVIGILANCE". THE TEAM CREATED A VIDEO PROVIDING AN IN-DEPTH OVERVIEW OF THE PAPER. "BLACK SWAN EVENTS AND INTELLIGENT AUTOMATION FOR ROUTINE SAFETY SURVEILLANCE" OUTLINES SEVERAL STRATEGIES TO ADDRESS DATA ON POTENTIAL BLACK SWAN EVENTS DURING DATA INGESTION. THE IAO TEAM UPDATED THE INTERACTIVE INDIVIDUAL CASE STUDY REPORT (ICSR) AND AUTOMATION TECHNOLOGIES TOOL (IATT) AND ACCOMPANYING TECHNOLOGY MATRIX. THE INTERPRETATION OF PHARMACOVIGILANCE GUIDANCES & REGULATIONS (IGR PV) INITIATIVE RELEASED THE PREGNANCY & BREASTFEEDING REGULATORY LANDSCAPE ASSESSMENT OUTPUTS, THE FIRST SOLUTION ADDRESSING THIS NEW TOPIC FOR TRANSCELERATE.THE PHARMACOVIGILANCE AGREEMENTS OPTIMIZATION (PVAO) INITIATIVE RELEASED VERSION 2.0 OF ITS PHARMACOVIGILANCE AGREEMENTS GLOSSARY. THE PVAO TEAM LAUNCHED A TABLE OF CONTENTS (TOC) THAT OFFERS A FRAMEWORK OF MODULES, HEADINGS, POINTS TO CONSIDER, AND REGULATORY REFERENCES TO MAKE NEGOTIATING AND COMPLYING WITH PVAS MORE EFFICIENT. IDENTIFIED AND CREATED TRANSCELERATE'S NEWEST INITIATIVE: RAPID SIGNAL ASSESSMENT USING REAL WORLD DATA (RSA-RWD). BIOCELERATE, A LIMITED LIABILITY COMPANY CLASSIFIED AS A DISREGARDED ENTITY IN WHICH TRANSCELERATE IS THE SOLE MEMBER, RELEASED VERSION 1.1 OF THE NONCLINICAL COMMON PROTOCOL AND COMMON REPORT TEMPLATES, WHICH FOCUSED ON INCREASING TEMPLATE USABILITY AND EASE OF IMPLEMENTATION TO HELP CROS, SPONSORS AND REGULATORS THROUGH CONSISTENCY AND EFFICIENCIES IN THE PROTOCOL AND REPORT GENERATION PROCESS. A PUBLIC PRIVATE PARTNERSHIP BETWEEN BIOCELERATE AND THE U.S. FOOD & DRUG ADMINISTRATION'S CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), IN CONJUNCTION WITH PHUSE, PUBLISHED THE OPEN-SOURCE R PACKAGE, SENDIGR, WHICH CAN ENABLE USERS TO SEARCH SEND STRUCTURED DATASETS TO SUPPORT CROSS-STUDY ANALYSIS USE CASES. THIS DATABASE SEARCH FUNCTIONALITY IS AN IMPORTANT TOOL IN APPLYING DATA ANALYTIC APPROACHES TO CROSS-STUDY PRECLINICAL TOXICOLOGY DATA.BIOCELERATE'S TOXICOLOGY & BACKGROUND CONTROL DATA INITIATIVE EXPANDED THE SCOPE OF EFFECTIVE DATA SHARING AGREEMENTS ACROSS PARTICIPATING COMPANIES TO SUPPORT SHARING OF STUDIES WITHIN THE DATACELERATE TECHNOLOGY PLATFORM. THIS INCLUDED EXPANDED OPTIONS ESSENTIAL FOR CURRENT ANALYTICAL EFFORTS AND FOUNDATIONAL FOR ENABLING TRANSLATIONAL SAFETY. WITH INCREASED DATA, THE TOXICOLOGY DATA SHARING (TDS) MODULE WILL ENABLE COMPANIES TO PERFORM BETTER TRANSLATION OF PRECLINICAL FINDINGS AND CLOSE CRITICAL GAPS THAT EXIST IN UNDERSTANDING THE RELATIONSHIP BETWEEN PATIENT RESPONSE AND PRECLINICAL TOXICOLOGY FINDINGS. 23814572 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 25 0 1 25 1 0 0 0 0 0 0 1 0 X 20 19 0 0 1 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 4845391230 300 CONSHOHOCKEN STATE ROAD STE 420 WEST CONSHOHOCKEN PA 19428 DALVIR GILL CEO (THRU 12/31/2022) 40.00 X X 2616517 0 81774 JANICE CHANG COO (CEO EFF 01/01/2023) 40.00 X 822931 0 39791 JENNIFER A BURGESS VP GLOBAL ENGAGEMENT AND COMMS 40.00 X 468177 0 46174 ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 40.00 X 403958 0 52157 CARA L RINALDI VP OF PORTFOLIO MANAGEMENT 40.00 X 401459 0 60158 JENEEN DONADEO EXEC. DIRECTOR OF PORTFOLIO MANAGEMENT 40.00 X 385561 0 31699 ROBERT DICICCO VP OF PORTFOLIO MANAGEMENT 40.00 X 305012 0 46549 KATHRYN OWEN CHAIR OF BOARD OF DIRECTOR 0.50 X 0 0 0 BADHRI SRINIVASAN VICE CHAIR OF BOARD OF DIRECTOR 0.50 X 0 0 0 ELIAV BARR BOARD MEMBER (EFF 04/2022) 0.50 X 0 0 0 DIETMAR BERGER BOARD MEMBER 0.50 X 0 0 0 ULI BROEDL BOARD MEMBER (EFF 02/2022) 0.50 X 0 0 0 CHRIS CORSICO BOARD MEMBER 0.50 X 0 0 0 CHRISTOPH KOENEN BOARD MEMBER (EFF 04/2022) 0.50 X 0 0 0 MARIA KOUTSOPOULOU BOARD MEMBER (EFF 04/2022) 0.50 X 0 0 0 BARI KOWAL BOARD MEMBER (EFF 01/2022) 0.50 X 0 0 0 MARTIN HOLST LANGE BOARD MEMBER 0.50 X 0 0 0 ROB LENZ BOARD MEMBER 0.50 X 0 0 0 IRIS LOEW-FRIEDRICH BOARD MEMBER 0.50 X 0 0 0 CRISTIAN MASSACESI BOARD MEMBER 0.50 X 0 0 0 ROBERT METCALF BOARD MEMBER 0.50 X 0 0 0 WILLIAM PAO BOARD MEMBER (EFF 05/2022) 0.50 X 0 0 0 MICHELLE ROHRER BOARD MEMBER 0.50 X 0 0 0 MOKASH SHARMA BOARD MEMBER (EFF 12/2022) 0.50 X 0 0 0 TADAAKI TANIGUCHI BOARD MEMBER (EFF 10/2022) 0.50 X 0 0 0 TAKUKO YAMADA-SAWADA BOARD MEMBER 0.50 X 0 0 0 ANDREW LEE TREASURER 0.50 X 0 0 0 ROBERT BAKER SECRETARY (THRU 12/2022) 0.50 X 0 0 0 ROY BAYNES BOARD MEMBER (THRU 04/2022) 0.50 X 0 0 0 ROD MACKENZIE BOARD MEMBER (THRU 04/2022) 0.50 X 0 0 0 JOHN OIDTMAN BOARD MEMBER (THRU 04/2022) 0.50 X 0 0 0 STUART POULTON BOARD MEMBER (THRU 01/2022) 0.50 X 0 0 0 STEFFEN ROELLINGER BOARD MEMBER (THRU 01/2022) 0.50 X 0 0 0 PETER RONCO BOARD MEMBER (THRU 10/2022) 0.50 X 0 0 0 MEHDI SHAHIDI BOARD MEMBER (THRU 02/2022) 0.50 X 0 0 0 BERNHARDT G ZEIHER BOARD MEMBER (THRU 09/2022) 0.50 X 0 0 0 5403615 0 358302 23 0 1 0 ACCENTURE LLP 161 N CLARK STREET CHICAGO IL 60601 CONSULTING & IT SERVICES 6984910 PA CONSULTING GROUP INC 10 BRESSENDEN PLACE LONDON UK CONSULTING SERVICES 6308637 KILPATRICK TOWNSEND 601 14TH STREET NW SUITE 900 WASHINGTON DC 20005 LEGAL SERVICES 2627402 ARTEMIS FACTOR LLC 314 CARLYLE ROAD WEST CHESTER PA 19382 CONSULTING SERVICES 2268141 FLUID EDGE 10 MYSTIC LANE MALVERN PA 19355 CONSULTING SERVICES 931487 24 MEMBERSHIP DUES 541900 33532000 33532000 33532000 68302 68302 33600302 33532000 0 68302 X 3561013 3561013 4460754 2998094 1462660 123975 77483 46492 468386 225134 243252 395434 146433 249001 2633444 1662366 971078 118552 118552 12889935 12035963 853972 44323 13876 30447 180784 1002 179782 7085996 6637352 448644 950049 950049 179977 16869 163108 253501 253501 249063 249063 EXCESS COMPENSATION TAX 339469 339469 RECRUITING 304338 304338 ADMINISTRATIVE FEES 15786 15786 CHARITABLE CONTRIBUTION 3303 3303 4290 4290 34262372 23814572 10447800 0 16588630 8408055 1067398 9591404 32595000 30235000 83526 221218 38830 26983 50373384 48482660 6206784 5246812 33532000 33262000 39738784 38508812 X 10634600 9973848 10634600 9973848 50373384 48482660 -662070 1318 0 X 0 0 0 0 1 0 X 0 0 0 DALVIR GILL CEO (THRU 12/31/2022) 686781 0 1929736 0 0 0 12200 0 69574 0 2698291 0 0 0 JANICE CHANG COO (CEO EFF 01/01/2023) 536003 0 286928 0 0 0 12200 0 27591 0 862722 0 0 0 JENNIFER A BURGESS VP GLOBAL ENGAGEMENT AND COMMS 314080 0 154097 0 0 0 12200 0 33974 0 514351 0 0 0 ANTHONY GARGES HEAD OF FINANCE AND ADMINISTRATION 230088 0 173870 0 0 0 12200 0 39957 0 456115 0 0 0 CARA L RINALDI VP OF PORTFOLIO MANAGEMENT 265824 0 135635 0 0 0 8235 0 51923 0 461617 0 0 0 JENEEN DONADEO EXEC. DIRECTOR OF PORTFOLIO MANAGEME 263280 0 122281 0 0 0 12200 0 19499 0 417260 0 0 0 ROBERT DICICCO VP OF PORTFOLIO MANAGEMENT 279575 0 25437 0 0 0 4652 0 41897 0 351561 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 I, LINE 6, TOTAL NUMBER OF VOLUNTEERS: THE TOTAL NUMBER OF VOLUNTEERS OF 29, ENCOMPASSES ALL ACTIVE BOARD MEMBER THROUGHOUT THE CALENDAR YEAR. FORM 990, PART VI, SECTION A, LINE 4 DURING 2022, THE BOARD OF DIRECTORS OF THE CORPORATION APPROVED AMENDING THE BYLAWS OF THE CORPORATION TO ELIMINATE THE BOARD SEAT RESERVED FOR MEMBERS IN THE ASSOCIATE MEMBER TIER, AND ACCORDINGLY TO REDUCE THE TOTAL NUMBER OF DIRECTORS FROM 22 TO 21 TO REFLECT THE ELIMINATION OF THE ASSOCIATE MEMBER BOARD SEAT. 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-ONE (21) 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; AND (IV) 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. THE CEO DIRECTOR SHALL SERVE EX-OFFICIO, FOR SO LONG AS HE OR SHE SHALL HOLD THE OFFICE OF CHIEF EXECUTIVE OFFICER. EACH TIER I MEMBER SHALL BE ENTITLED TO THREE (3) VOTES AT EVERY MEETING OF MEMBERS ON MATTERS WHICH TIER I 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. 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 ORGANIZATION'S EXECUTIVE COMPENSATION COMMITTEE, CONSISTING OF INDEPENDENT DIRECTORS, 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, CONFLICT OF INTEREST POLICY AND OTHER CORPORATE POLICIES ARE AVAILABLE UPON REQUEST. FORM 990, PART IX, LINE 11G PROJECT MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 8,996,705. MANAGEMENT AND GENERAL EXPENSES 20,286. TOTAL EXPENSES 9,016,991. EXTERNAL CONTRACTOR SUPPORT: PROGRAM SERVICE EXPENSES 881,938. MANAGEMENT AND GENERAL EXPENSES 141,281. TOTAL EXPENSES 1,023,219. COMMUNICATIONS FEES: PROGRAM SERVICE EXPENSES 127,511. MANAGEMENT AND GENERAL EXPENSES 692,405. TOTAL EXPENSES 819,916. CHANGE MANAGEMENT FEES: PROGRAM SERVICE EXPENSES 2,029,809. TOTAL EXPENSES 2,029,809. BIOCELERATE LLC 300 CONSHOHOCKEN STATE ROAD STE 420 WEST CONSHOHOCKEN PA 19428 475492971 TO IMPROVE EFFICIENCIES IN PRECLINICAL RESEARCH. DE 1530000 3077112 TRANSCELERATE BIOPHARMA INC