2024-10-03T08:05:34-05:00 2023-12-31 BDO USA 200 PARK AVENUE 38TH FLOOR NEW YORK NY 10166 990 2023-01-01 134128413 GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT INC % ANGELA VANDERPLOEG GLOB 2122277540 80 PINE STREET 20TH FLOOR NEW YORK NY 10005 MELVIN SPIGELMAN PRESIDENT/CEO 2122277540 2024-10-01 true true Paul Hammerschmidt P01384178 2128858000 2024-10-01 2023 2024-10-15 13:58:12Z TB ALLIANCE MELVIN SPIGELMAN 80 PINE STREET 20TH FLOOR NEW YORK NY 10005 66012081 false X WWW.TBALLIANCE.ORG X 2000 DE TO ACCELERATE THE DISCOVERY & DEVELOPMENT OF NEW DRUGS TO FACILITATE THE CONTROL OF TUBERCULOSIS THROUGHOUT THE WORLD AND THE ACCESSIBILITY OF THESE DRUGS TO THE GLOBAL COMMUNITY. 10 9 55 9 0 0 52646326 49796816 0 0 2631898 8182816 934739 2260854 56212963 60240486 263496 278450 0 0 16259751 17365566 0 0 1260040 39262643 37734563 55785890 55378579 427073 4861907 176686879 197319541 11506360 25619991 165180519 171699550 X TB ALLIANCE IS A NOT-FOR-PROFIT ORGANIZATION DEDICATED TO THE DISCOVERY, DEVELOPMENT AND DELIVERY OF BETTER, FASTER-ACTING AND AFFORDABLE TUBERCULOSIS DRUGS THAT ARE AVAILABLE TO THOSE WHO NEED THEM. false false 42131937 0 0 RESEARCH AND DEVELOPMENT - TB ALLIANCE IS A NOT-FOR-PROFIT PRODUCT DEVELOPMENT PARTNERSHIP (PDP), UNIQUELY POSITIONED TO LEVERAGE A GLOBAL NETWORK OF PUBLIC AND PRIVATE PARTNERS TO MOST EFFICIENTLY ADVANCE TB DRUG DEVELOPMENT. A PDP BUILDS PARTNERSHIPS BETWEEN THE PUBLIC, PRIVATE, ACADEMIC, AND PHILANTHROPIC SECTORS TO DRIVE THE DEVELOPMENT OF NEW PRODUCTS FOR UNDERSERVED MARKETS. PDPS RETAIN DIRECT MANAGEMENT OVERSIGHT OF THEIR PROJECTS, THOUGH MUCH OF THE LABORATORY AND CLINICAL WORK IS DONE THROUGH EXTERNAL RESEARCH FACILITIES AND CONTRACTORS. WE COMBINE THE RESEARCH AND DEVELOPMENT EXPERTISE OF OUR STAFF WITH THE SKILLS AND RESOURCES OF OUR PARTNERS TO HARNESS THE MOST PROMISING SCIENCE WHEREVER IT MAY EXIST AROUND THE WORLD. THIS MODEL MINIMIZES COSTS, INCLUDING OVERHEAD AND INVESTMENTS IN INFRASTRUCTURE, WHILE OPTIMIZING SCIENTIFIC CAPABILITY TO SPEED NEW TB DRUG DEVELOPMENT. OUR BUSINESS MODEL AND DIVERSE PARTNERSHIPS ALLOW TB ALLIANCE TO LEVERAGE ADDITIONAL PARTNER SERVICES FOR EVERY DOLLAR INVESTED IN ITS PROGRAMS. SIMPLICITB - SIMPLICITB WAS A PHASE III CLINICAL TRIAL EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF A NOVEL AND POTENTIALLY SHORTER DRUG REGIMEN (BPAMZ) FOR PATIENTS WITH DRUG-SENSITIVE (DS) AND DRUG-RESISTANT (DR) PULMONARY TUBERCULOSIS (SPECIFICALLY MULTIDRUG-RESISTANT TB AND MONO-RESISTANCE TO ISONIAZID OR RIFAMPICIN). THE BPAMZ REGIMEN IS COMPRISED OF FOUR DIFFERENT ANTIMICROBIALS: BEDAQUILINE (B), PRETOMANID (PA), MOXIFLOXACIN (M) AND PYRAZINAMIDE (Z). THE DRUG REGIMEN WAS ADMINISTERED FOR FOUR MONTHS TO PATIENTS WITH DS-TB, AND FOR SIX MONTHS TO PATIENTS WITH MDR-TB OR MONO-RESISTANCE TO RIFAMPICIN OR ISONIAZID. THE RESULTS OF THIS CLINICAL TRIAL WERE PUBLISHED IN LANCET INFECTIOUS DISEASES. SUTEZOLID - SUTEZOLID IS A PROMISING CLINICAL-STAGE TB DRUG CANDIDATE FROM THE OXAZOLIDINONE CLASS. TB ALLIANCE HAS IMPLEMENTED AN OPEN DEVELOPMENT APPROACH TO ADVANCE THE PHASE 2 TB DRUG CANDIDATE, SUTEZOLID, WHICH COULD BE A COMPONENT OF A NEXT-GENERATION TB REGIMEN. TB ALLIANCE HAS MADE SUTEZOLID AVAILABLE FOR STUDY BY ALL RESEARCHERS WHO COMMIT TO MAKING THEIR RESULTS AVAILABLE TO THE BROADER TB RESEARCH COMMUNITY. THIS NOVEL APPROACH HAS CONTRIBUTED TO THREE CLINICAL TRIALS THAT BEGAN IN 2023. NC-009 - NC-009 IS A PAN-PHASE 2 CLINICAL TRIAL INCORPORATING ELEMENTS OF PHASE 2A, B, AND C TO EVALUATE THE SAFETY AND EFFICACY OF A COMBINATION OF A NEW EXPERIMENTAL COMPOUND, TBAJ-876, WITH PRETOMANID AND LINEZOLID, COMPONENTS OF TB ALLIANCE'S BPAL REGIMEN. THIS REGIMEN HAS THE POTENTIAL TO SHORTEN AND IMPROVE TREATMENT FOR BOTH DRUG-SENSITIVE AND DRUG-RESISTANT FORMS OF TB. RESULTS FROM PRECLINICAL AND PHASE 1 STUDIES WERE PRESENTED AT THE 2023 UNION CONFERENCE ON LUNG HEALTH AND SHOWED THAT THE NEW COMPOUND, TBAJ-876, WHEN COMPARED WITH BEDAQUILINE (A TB MEDICINE IN THE SAME DRUG CLASS), ELIMINATED TB BACTERIA FASTER AND HAD A POTENTIALLY SAFER PROFILE. NC-009 WILL TEST DIFFERENT DOSES OF TBAJ-876 IN COMBINATION WITH PRETOMANID AND LINEZOLID AGAINST THE CURRENT STANDARD OF CARE FOR DRUG-SENSITIVE TB - ISONIAZID, RIFAMPICIN, PYRAZINAMIDE, AND ETHEMBUTOL (HRZE). ANOTHER ARM OF THE TRIAL WILL ALSO TEST PRETOMANID AND LINEZOLID IN COMBINATION WITH BEDAQUILINE (BPAL), A REGIMEN NOW RECOMMENDED BY THE WORLD HEALTH ORGANIZATION TO TREAT SOME FORMS OF DR-TB, AGAINST DRUG-SENSISTIVE TB. THE STUDY AIMS TO ENROLL 300 PARTICIPANTS WITH DRUG-SENSITIVE TB AT 21 CLINICAL TRIAL SITES IN FIVE COUNTRIES: GEORGIA, PHILIPPINES, SOUTH AFRICA, TANZANIA, AND UGANDA. LIFT-TB (LEVERAGING INNOVATION FOR FASTER TREATMENT OF TB) - THIS ACCESS PROGRAM, LAUNCHED IN 2020, SEEKS TO INCREASE TREATMENT COMPLETION RATES FOR DRUG-RESISTANT TB THROUGH ADOPTION AND SCALE UP OF NEW REGIMENS, BEGINNING WITH BPAL. IT FOCUSES ON SEVEN HIGH-BURDEN SOUTHEAST AND CENTRAL ASIAN COUNTRIES THAT SHOULDER APPROXIMATELY 1 IN 5 OF THE GLOBAL TB CASES. AS OF 2023, MORE THAN 70 COUNTRIES HAVE PROCURED THE SIX-MONTH, ALL-ORAL BPAL REGIMEN TO TREAT MORE THAN 40,000 PEOPLE WITH DRUG-RESISTANT TB. FAST TRACK THE CURE - IN SUPPER OF THE WORLD HEALTH ORGANIZATION'S CALL TO ACTION TO ACCELERATE ACCESS TO SHORTER DR-TB CURES FOR ALL, THE FAST TRACK THE CURE MOVEMENT BRINGS COMMUNITIES AROUND THE WORLD TOGETHER TO RAISE AWARENESS AND FACILITATE ACCESS TO NEW DR-TB TREATMENTS, WHILE RAMPING UP ADVOCACY TO CONVINCE WORLD LEADERS THAT SIX-MONTH DR-TB CURES MUST BE WIDELY ADOPTED AND AVAILABLE TO ALL WHO NEED THEM. FAST TRACK THE CURE IS ALSO COLLABORATING CLOSELY WITH STOP TB TO ENSURE STRATEGIC ALIGNMENT AND PARTNERSHIP AND WITH THE CHALLENGE FACILITY FOR CIVIL SOCIETY MOVEMENT, BY ALIGNING WITH THEIR COMMUNITY ENGAGEMENT, CAPACITY BUILDING, AND DEMAND CREATION PILLARS AND FOCUS. SLASH-TB - TB ALLIANCE AND THE SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE HAVE DEVELOPED SLASH-TB (SAVINGS FROM LEVERAGING & ADOPTING SHORTER & HIGHLY EFFECTIVE TB TREATMENTS), A MODEL TO ESTIMATE COST SAVINGS FOR HEALTH SERVICE SYSTEMS, PATIENTS, FAMILIES, AND/OR CAREGIVERS WHEN USING THE BPAL/M REGIMENS AS COMPARED TO STANDARD DRUG-RESISTANT TB TREATMENTS. 5947379 278450 0 PUBLIC AFFAIRS AND POLICY - TB ALLIANCE MAINTAINS CRITICAL ALLIANCES WITH PUBLIC AND PRIVATE ORGANIZATIONS TO RAISE AWARENESS ABOUT TUBERCULOSIS ("TB") AND ADVOCATE FOR PUBLIC AND PRIVATE INVOLVEMENT IN RESEARCH FOR THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY FOR THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR ON THE DEVELOPMENT OF THESE MEDICINES. TB ALLIANCE CONTINUES TO PURSUE AN EXPLICIT COMMITMENT TO OUR "AAA MANDATE" - THAT ALL NEW PRODUCTS WILL BE ADOPTED, AVAILABLE AND AFFORDABLE TO THOSE WITH TB. 764217 0 0 BUSINESS DEVELOPMENT - TB ALLIANCE NEGOTIATES, IMPLEMENTS AND MANAGES AGREEMENTS WITH PUBLIC AND PRIVATE ORGANIZATIONS WORLDWIDE AND DOES SO BY ADHERING TO SOUND BUSINESS PRACTICES WHILE ENSURING THE PUBLIC GOOD. SPECIFICALLY, TB ALLIANCE NEGOTIATES TERMS THAT SUPPORT THE DEVELOPMENT AND ACCESS OF NEW AFFORDABLE ANTI-TB DRUGS EQUITABLY TO THOSE AREAS MOST IN NEED WHILE ENCOURAGING THE PRIVATE SECTOR TO HELP DEVELOP NEW MEDICINES FOR TB INDICATIONS. 48843533 true true false false false false false false false false true false false true true true true false false true true true false false false false false true false true false false false false false false false false false false false false false false false false false true 62 0 true 55 true false false false false false false false false false false false false X 10 9 false false false false false false false true true false false true true true true true true true true false NY X X ANGELA VANDERPLOEG 2122277540 80 PINE STREET 20TH FLOOR NEW YORK NY 10005 X DR MELVIN SPIGELMAN PRESIDENT/CEO 45.0 0.0 X X 921007 0 107776 DR NADER FOTOUHI SR. VP, CHIEF SCIENTIFIC OFF. 45.0 0.0 X 545570 0 114466 DR EUGENE SUN SR. VP, RESEARCH & DEV'T 45.0 0.0 X 562265 0 86040 MARIA BEUMONT VP, CHIEF MEDICAL OFFICER 45.0 0.0 X 483078 0 81608 COLLEEN PERO SECRETARY/CAO 45.0 0.0 X 457040 0 68861 ROBERT LORETTE SR. VP, BUSINESS DEVELOPMENT 45.0 0.0 X 437313 0 83939 ANGELA VANDERPLOEG TREASURER/CFO 45.0 0.0 X 411013 0 100307 SANDEEP JUNEJA SR. VP, MARKET ACCESS 45.0 0.0 X 406262 0 99678 KATHLEEN SCHOSTACK SR. VP, PROG. & ALLIANCE MGMT 45.0 0.0 X 419997 0 82950 SALAH FORAIDA SR. DIRECTOR, MEDICAL AFFAIRS 45.0 0.0 X 418194 0 50829 RAJNEESH TANEJA VP, PHARMACEUTICAL PROD. DEV'T 45.0 0.0 X 360974 0 77744 PIETRO TURILLI SR.VP, EXTERNAL AFFAIRS 45.0 0.0 X 327992 0 91064 DAVID NORTON CHAIR 3.0 0.0 X X 0 0 0 ARIEL PABLOS-MENDEZ VICE CHAIR 3.0 0.0 X X 0 0 0 ERIC GOOSBY DIRECTOR 3.0 0.0 X 0 0 0 RASHA HIBRI DIRECTOR 3.0 0.0 X 0 0 0 SUNDAR KODIYALAM DIRECTOR 3.0 0.0 X 0 0 0 MARIO RAVIGLIONE DIRECTOR 3.0 0.0 X 0 0 0 KIM SCHWARTZ DIRECTOR 3.0 0.0 X 0 0 0 MITCHELL WARREN DIRECTOR 3.0 0.0 X 0 0 0 RATAN WATAL DIRECTOR eff. 1/1/2023 3.0 0.0 X 0 0 0 5750705 0 1045262 45 false true false WUXI APPTEC HONGKONG LIMITED UNIT C 20/F NO 998 CANTON RD KOWLOON 0 CH INTEGRATED R&D SVCS 4087514 PPD DEVELOPMENT LP 26361 Network Place CHICAGO IL 60673 GLOBAL CRO 3363176 Worldwide Clinical Trials 4509 Freidrich Ln Blg 2 Ste 200 AUSTIN TX 78744 GLOBAL CRO 2337577 University of Illinois 28395 Network Place CHICAGO IL 60673 Research collab. 2185796 GLAXOSMITHKLINE INVESTIGACION 28760 TRES CANTOS MADRID 0 SP EXT. MINI PORTFOLIOS 1600000 62 31693916 18102900 49796816 0 8060173 8060173 0 279003 279003 0 0 0 5894238 5771595 122643 122643 122643 0 0 0 0 0 0 0 0 0 MISCELLANEOUS INCOME 900099 1981851 1981851 1981851 60240486 0 10443670 X 17436 17436 0 261014 261014 0 4358087 2899866 1172864 285357 0 9825990 7837412 1471173 517405 917447 736623 132470 48354 1516953 1202330 243632 70991 747089 569880 135746 41463 0 794479 746167 48312 135690 135690 0 0 94033 94033 6974937 6486360 417379 71198 0 229651 68489 159776 1386 1087453 443412 609871 34170 0 787118 575190 165017 46911 1174079 897298 163004 113777 0 138385 97096 41289 0 0 186444 136435 38489 11520 234523 93143 141380 R&D PROJECT EXPENSES 25704187 25704187 DUES AND SUBSCRIPTIONS 193584 71195 104881 17508 55378579 48843533 5275006 1260040 0 0 159750193 143923233 4239015 1821719 1094599 1102554 0 0 0 0 0 0 0 0 1057756 1426170 6490141 4954230 724376 1535911 9761242 31709868 0 0 0 0 0 0 59698 15800086 176686879 197319541 11073526 8012001 0 0 419100 1205080 0 0 0 0 0 0 0 0 0 0 13734 16402910 11506360 25619991 X 165180519 171699550 0 0 165180519 171699550 176686879 197319541 X 4861907 1661247 -4123 X false true X true true true X 68288037 60247338 58183286 52646326 49796816 289161803 0 0 68288037 60247338 58183286 52646326 49796816 289161803 95946646 193215157 1399584 960126 77877 2686767 8339176 13463530 0 186278 59988 392216 901316 1981851 3521649 306146982 0.63112 0.62968 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 4325574 3702380 623194 758058 688745 69313 1406509 563105 843404 1535911 ROU - OPERATING LEASES 15740388 SECURITY DEPOSITS 59698 15800086 0 OPERATING LEASE LIABILITIES 16402578 DEFERRED RENT 332 16402910 X 61807700 1661247 1661247 60146453 94033 94033 60240486 55284546 55284546 94033 94033 55378579 PART X, LINE 2: TB Alliance is subject to the provisions of the Financial Accounting Standards Board's (FASB) Accounting Standards Codification (ASC) Topic 740, Income Taxes, as it relates to accounting and reporting for uncertainty in income taxes. TB Alliance does not believe it has taken any material uncertain tax positions and, due to its general not-for-profit status, management believes ASC Topic 740 has not had, and is not anticipated to have, a material impact on TB Alliance's financial statements. true East Asia and the Pacific Program Services ADMIN EXPENSES 96948 East Asia and the Pacific 8 Program Services CONSULTING SERVICES 4096868 East Asia and the Pacific Program Services R&D RESEARCH 1411865 East Asia and the Pacific Grantmaking 3000 Europe (Including Iceland and Greenland) Program Services ADMIN EXPENSES 615175 Europe (Including Iceland and Greenland) 13 Program Services CONSULTING SERVICES 1587722 Europe (Including Iceland and Greenland) Program Services R&D RESEARCH 4729902 Europe (Including Iceland and Greenland) Grantmaking 5143 Middle East and North Africa Program Services ADMIN EXPENSES 39442 Middle East and North Africa Program Services R&D RESEARCH 9150 North America Program Services ADMIN EXPENSES 47103 North America 2 Program Services CONSULTING SERVICES 110935 North America Program Services R&D RESEARCH 7016 Russia and the Newly Independent States Program Services ADMIN EXPENSES 401 Russia and the Newly Independent States 2 Program Services CONSULTING SERVICES 93390 Russia and the Newly Independent States Program Services R&D RESEARCH 151701 Russia and the Newly Independent States Grantmaking 14730 South America Program Services ADMIN EXPENSES 15000 South America 1 Program Services CONSULTING SERVICES 716 South America Program Services R&D RESEARCH 28032 South America Grantmaking 35508 South Asia Program Services ADMIN EXPENSES 10519 South Asia 6 Program Services CONSULTING SERVICES 382183 South Asia Program Services R&D RESEARCH 2205508 South Asia Grantmaking 750 Sub-Saharan Africa Program Services ADMIN EXPENSES 479576 Sub-Saharan Africa 1 6 Program Services SALARY & FRINGE BENEFI 1022275 Sub-Saharan Africa 5 Program Services CONSULTING SERVICES 143700 Sub-Saharan Africa Program Services R&D RESEARCH 1781211 Sub-Saharan Africa Grantmaking 201883 25 1 18 1 43 13020491 6306861 19327352 Europe (Including Iceland and Greenland) COMMUNITY ENGAGEMENT 5143 WIRE Russia and the Newly Independent States COMM. ENGAGE 13980 WIRE South America COMM. ENGAGE 35508 WIRE Sub-Saharan Africa COMM. ENGAGE 8000 WIRE Sub-Saharan Africa COMM. ENGAGE 16196 WIRE Sub-Saharan Africa COMM. ENGAGE 17180 WIRE Sub-Saharan Africa COMM. ENGAGE 31000 WIRE Sub-Saharan Africa COMM. ENGAGE 17614 WIRE Sub-Saharan Africa COMM. ENGAGE 19725 WIRE Sub-Saharan Africa COMM. ENGAGE 18102 WIRE Sub-Saharan Africa COMM. ENGAGE 68445 WIRE 11 false false false false false false PART I, LINE 2: THE GRANTEE IS REQUIRED TO PROVIDE THE ORGANIZATION WITH AN ITEMIZED ACCOUNTING OF EXPENDITURES FOR THE PROJECT AND A REPORT ON THE PROGRESS OF THE PROJECT ON A SCHEDULE SPECIFIED IN THE AGREEMENT. THIS REQUIREMENT IS OUTLINED IN THE SIGNED AGREEMENT BETWEEN BOTH PARTIES. true NATIONAL TB CONTROLLERS ASSOCIATION PO BOX 260288 ATLANTA GA 30326 742739257 501(C)(3) 15000 COMM. ENGAGE 1 PART I, LINE 2: The grantee is required to provide the organization with an itemized accounting of expenditures for the Project and a report on the progress of the Project on a schedule specified in the agreement. This requirement is outlined in the signed agreement between both parties. X X X X X false false false false false false false true false DR MELVIN SPIGELMAN PRESIDENT/CEO 640189 0 280818 0 0 0 66000 0 41776 0 1028783 0 0 0 COLLEEN PERO SECRETARY/CAO 360491 0 96549 0 0 0 44970 0 23891 0 525901 0 0 0 ANGELA VANDERPLOEG TREASURER/CFO 321350 0 89663 0 0 0 41296 0 59011 0 511320 0 0 0 DR EUGENE SUN SR. VP, RESEARCH & DEV'T 440799 0 121466 0 0 0 49168 0 36872 0 648305 0 0 0 DR NADER FOTOUHI SR. VP, CHIEF SCIENTIFIC OFF. 426677 0 118893 0 0 0 54725 0 59741 0 660036 0 0 0 PIETRO TURILLI SR.VP, EXTERNAL AFFAIRS 281854 0 46138 0 0 0 32689 0 58375 0 419056 0 0 0 ROBERT LORETTE SR. VP, BUSINESS DEVELOPMENT 344453 0 92860 0 0 0 42742 0 41197 0 521252 0 0 0 KATHLEEN SCHOSTACK SR. VP, PROG. & ALLIANCE MGMT 329434 0 90563 0 0 0 41685 0 41265 0 502947 0 0 0 SALAH FORAIDA SR. DIRECTOR, MEDICAL AFFAIRS 358908 0 59286 0 0 0 41771 0 9058 0 469023 0 0 0 SANDEEP JUNEJA SR. VP, MARKET ACCESS 317751 0 88511 0 0 0 40766 0 58912 0 505940 0 0 0 RAJNEESH TANEJA VP, PHARMACEUTICAL PROD. DEV'T 295943 0 65031 0 0 0 35841 0 41903 0 438718 0 0 0 MARIA BEUMONT VP, CHIEF MEDICAL OFFICER 396636 0 86442 0 0 0 43500 0 38108 0 564686 0 0 0 PART I, LINE 7: VARIABLE COMPENSATION IS PAID TO STAFF MEMBERS BASED ON ANNUAL PERFORMANCE. SEE SCHEDULE O RESPONSE TO FORM 990, PART VI, SECTION B, LINES 15A AND 15B FOR FURTHER DETAILS. FORM 990, PART VI, SECTION B, LINE 11B: FORM 990 WAS PREPARED BY A NATIONALLY RECOGNIZED ACCOUNTING FIRM IN CONJUNCTION WITH THE ORGANIZATION'S FINANCE DEPARTMENT. THE DRAFT OF FORM 990 WAS REVIEWED BY THE ORGANIZATION'S FINANCE DEPARTMENT AND SENIOR MANAGEMENT, AND THEN PROVIDED TO ALL MEMBERS OF THE BOARD OF DIRECTORS IN DRAFT VIA ELECTRONIC MAIL, WITH AN OPPORTUNITY FOR THEM TO COMMENT OR MAKE INQUIRY BEFORE IT WAS FILED WITH THE INTERNAL REVENUE SERVICE. FORM 990, PART VI, SECTION B, LINE 12C: THE ORGANIZATION'S CONFLICT OF INTEREST POLICY IS DISTRIBUTED TO OFFICERS AND DIRECTORS ANNUALLY ALONG WITH A QUESTIONNAIRE THAT IS COMPLETED BY ALL OFFICERS AND DIRECTORS IN WHICH THEY ARE ASKED TO DISCLOSE INFORMATION REGARDING ACTUAL OR POTENTIAL CONFLICTS OF INTEREST. THESE QUESTIONNAIRES ARE COLLECTED AND REVIEWED ANNUALLY TO ENSURE COMPLIANCE WITH THE CONFLICT OF INTEREST POLICY. THE POLICY ITSELF ALSO REQUIRES ANY DIRECTOR OR OFFICER TO PROMPTLY DISCLOSE ANY CONFLICT OF INTEREST. INTERESTED DIRECTORS AND OFFICERS ARE REQUIRED TO RECUSE THEMSELVES FROM ANY DECISION ON MATTERS IN WHICH THEY HAVE AN INTEREST, AND SUCH RECUSAL IS NOTED IN THE MINUTES. FORM 990, PART VI, SECTION B, LINES 15A AND 15B: THE COMPENSATION COMMITTEE, WHICH CONSISTS OF THREE INDEPENDENT BOARD MEMBERS, ANNUALLY REVIEWS THE CEO AND OFFICERS COMPENSATION IN CONJUNCTION WITH AN EVALUATION OF ORGANIZATIONAL PERFORMANCE. THE COMMITTEE RECOMMENDS ADJUSTMENTS IN COMPENSATION TO THE FULL BOARD FOR REVIEW AND APPROVAL, WITHIN THE CONTEXT OF AN AGREED UPON COMPETITIVE POSITION. THE COMPETITIVENESS OF COMPENSATION IS PERIODICALLY BENCHMARKED USING INDEPENDENT SALARY SURVEY DATA FROM THE NOT-FOR-PROFIT AND FOR-PROFIT INDUSTRY. THE COMPENSATION COMMITTEE DOCUMENTATION INCLUDES THE PERFORMANCE ASSESSMENT, COMPARABLE DATA AND THE SOURCE OF THIS DATA, AND THE RECOMMENDED ADJUSTMENTS. THE MINUTES OF THE FULL BOARD INCLUDE DOCUMENTATION OF THE APPROVED DECISIONS. THE MINUTES OF THE BOARD AND COMMITTEE ARE PREPARED BEFORE THE LATER OF THE NEXT MEETING OR 60 DAYS AFTER THE FINAL DECISION OF THE BOARD AND THE COMMITTEE. FORM 990, PART VI, SECTION C, LINE 19: THE ORGANIZATION MAKES ITS GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC UPON REQUEST. FORM 990, PART IX, LINE 11G: PROFESSIONAL SERVICES AND AGREEMENTS INCLUDE INDIVIDUAL CONSULTANTS WHO ARE CONTRIBUTING THEIR SPECIFIC EXPERTISE RELATED TO OUR CLINICAL TRIALS AND OTHER EARLY STAGE AND PRECLINICAL DISCOVERY WORK. EXPERTISE IN SUCH AREAS AS PHARMACOVIGILANCE, NON-GLP BIOANALYSIS, ANALYTICAL EVALUATION OF DRUG STABILITY AND PROGRAM MANAGEMENT ARE SOME OF THE SERVICES REQUIRED IN ORDER TO COMPLETE OUR SCIENTIFIC RESEARCH AND DEVELOPMENT. THESE CONSULTANTS ARE MANAGED BY OUR STAFF, WHO COORDINATE THE WORK NECESSARY TO BE COMPLETED AMONG ALL OUTSIDE PARTIES. FORM 990, PART XI, LINE 9: FOREIGN TRANSLATION LOSS....$ (4,123) FORM 990 PART IX LINE 11G DESCRIPTION:PROF. SVCS & AGREEMENTS TOTAL FEES:6974937