The University Of Chicago

VACCINE ADJUVANT DISCOVERY PROGRAM (VADP)

DATA COMMONS SOFTWARE AS A SERVICE

IARPA RESEARCH

GDC IMPLEMENTATION

SERVICES: NONPRODUCT.

CENTERS FOR RESEARCH ON STRUCTURAL BIOLOGY OF INFECTIOUS DISEASES

A. PRODUCT DEVELOPMENT ACTIVITIES SPECIFICALLY, THE SUBCONTRACTOR SHALL: 1. PROVIDE THE EQUIPMENT, FACILITIES, PERSONNEL AND OTHER RESOURCES M72 PRODUCTION. A. SUB-ACTIVITY: THE SUBCONTRACTOR WILL PRODUCE M72 ON SUFFICIENT QUANTITIES TO SUPPORT ALL FORMULATION AND PRE-CLINICAL ACTIVITIES UNDER THIS AWARD. 2. PROVIDE THE EQUIPMENT, FACILITIES, PERSONNEL AND OTHER RESOURCES FOR THE IN VITRO AND EX VIVO EVALUATION OF THE OPTIMIZED UM-1098 FORMULATIONS. A. SUB-ACTIVITY: THE SUBCONTRACTOR WILL CONDUCT A SERIES OF ESTABLISHED IN VITRO ASSAYS FOR THE COMPARATIVE EVALUATION OF OPTIMIZED UM-1098 POTENCY AND RECEPTOR SPECIFICITY THROUGH CYTOKINE PROFILING AND RECEPTOR SPECIFICITY ASSAYS. B. SUB-ACTIVITY: THE SUBCONTRACTOR WILL COMPLETE MULTIOMICS STUDIES TO IDENTIFY BIOMARKERS PREDICTING ANTIGEN-SPECIFIC ADAPTIVE IMMUNE RESPONSE, USING A SERIES OF SOPHISTICATED EX VIVO ASSAYS TO DETERMINE THE MECHANISMS OF VACCINE-MEDIATED IMMUNITY. 3. PROVIDE THE EQUIPMENT, FACILITIES, PERSONNEL AND OTHER RESOURCES FOR THE IN VIVO EVALUATION OF THE OPTIMIZED UM-1098 FORMULATIONS. A. SUB-ACTIVITY: THE SUBCONTRACTOR WILL CONDUCT A COMPREHENSIVE IN VIVO EVALUATION OF THE SAFETY AND IMMUNOGENICITY OF THE OPTIMIZED UM-1098 FORMULATIONS IN MICE. B. SUB-ACTIVITY: THE SUBCONTRACTOR WILL IDENTIFY THE OPTIMAL UM-1098 VACCINE FORMULATION, DOSE, AND TIMING. C. SUB-ACTIVITY: THE SUBCONTRACTOR WILL COMPLETE A COMPREHENSIVE EVALUATION OF THE LEAD UM-1098 FORMULATIONS IN MURINE VACCINATION AND MTB CHALLENGE STUDIES IN WT AND HUMANIZED MINCLE/MCL MICE. D. SUB-ACTIVITY: THE SUBCONTRACTOR WILL ASSESS THE PRE-CLINICAL (IND-ENABLING) SAFETY AND EFFICACY OF UM-1098 IN A NHP VACCINATION AND MTB CHALLENGE STUDY. E. SUB-ACTIVITY: THE SUBCONTRACTOR WILL CONDUCT STUDIES TO ASSESS THE MECHANISMS OF VACCINE-MEDIATED IMMUNITY AND IMMUNOPATHOLOGY FOLLOWING PATHOGEN CHALLENGE. B. QUALITY ASSURANCE, QUALITY CONTROL, DATA MANAGEMENT SPECIFICALLY, THE SUBCONTRACTOR SHALL: 1. COMPLETE QUARTERLY, SEMI-ANNUAL AND ANNUAL TECHNICAL AND FINANCIAL REPORTS TO FACILITATE CONTRACTOR TO FOLLOW THE SCHEDULE PROVIDED IN THE BAA AND EXECUTED CONTRACT AGREEMENT. 2. ATTEND ANNUAL REVIEW MEETINGS TO PROVIDE AN UPDATE ON DEVELOPMENT CONTRACT PROGRESS AND FUTURE DIRECTIONS. 3. PROVIDE THE NECESSARY BIOSTATISTICAL SUPPORT TO ENSURE RESEARCH REPRODUCIBILITY AND RIGOR. 4. PROVIDE THE NECESSARY IT SYSTEMS TO ENSURE AN APPROPRIATE LEVEL OF DATA MANAGEMENT AND INTEGRITY. C. PROJECT MANAGEMENT SPECIFICALLY, THE SUBCONTRACTOR SHALL: 1. PROVIDE THE PROJECT MANAGEMENT AND ORGANIZATIONAL FRAMEWORK NECESSARY TO SUPPORT ALL ACTIVITIES OUTLINED IN THIS SUBCONTRACT. 2. PROVIDE THE NECESSARY FINANCE, ADMINISTRATIVE, BUSINESS, AND LEGAL STAFF NECESSARY FOR PERFORMANCE OF THIS CONTRACT. 3. THE SUBCONTRACTOR ACKNOWLEDGES THE GOVERNMENT’S RIGHT TO MODIFY THE MILESTONES, PROGRESS, SCHEDULE, BUDGET, OR PRODUCT TO ADD OR DELETE PRODUCTS, PROCESS OR SCHEDULE AS THE NEED MAY ARISE. 4. THE SUBCONTRACTOR ACKNOWLEDGES THAT ACTIVITIES WITHIN THE SUBCONTRACT’S STATEMENT OF WORK SHALL ONLY BE CONDUCTED AS REQUESTED AND APPROVED BY THE CONTRACTOR’S AUTHORIZED OFFICIAL OR DESIGNEE. THE SUBCONTRACTOR MAY NOT CONDUCT WORK ON THE SUBCONTRACT WITHOUT PRIOR APPROVAL FROM THE CONTRACTOR’S AUTHORIZED OFFICIAL OR DESIGNEE; AND APPROVAL TO CARRY OUT SPECIFIC ACTIVITIES WILL BE LINKED TO APPROVAL BY THE CONTRACTOR’S REPRESENTATIVE OF THE SCOPE OF WORK, FOLLOWING SUBCONTRACT AWARD, AND RECEIPT OF TECHNICAL PROGRESS REPORTS.

CONDUCT FORMATIVE QUALITATIVE AND QUANTIATIVE RESEARCH, WHICH INCLUDES DETERMINING THE MOST CURREN AND CULTURALLY APPROPRIATE WAYS TO MARKET TO AND RECRUIT FOR THE RESEARCH STUDY, PILOTING OF THE SURVEY INSTRUMENT; AND MIXED METHODS RESEARCH TO IDENTIFY SOCIAL AND/OR SEX PARTNER MEETING VENUES ACCEPTABLE AND ACCESSIBLE TO EACH POPULATION OF INTEREST; RECRUIT PARTICIPANTS; ENSURE ALL DATA ARE CLEANED AND STADARDIZED.