Statement of Work (SOW) Dated April 24, 2020CLIN0001 Cue Health Monitoring System with Cue Influenza Cartridge and Cue Health MobileApp and Cue Professional Mobile AppObjectiveTo accelerate the, validation, regulatory authorization, and commercialization of the (b) (4)(b) (4)professional point-of-care (POC)/CLIA Waived Cue Influenza Cartridge for use with the CueHealth Monitoring System and the Cue Health Mobile Application for (b) (4)professionaloperators. Activities described herein will result in:submissions for the Cue Health Monitoring System with Cue Influenza Cartridge forPOC/CLIA Waived claimsExpected 510k clearances and commercial availability of (b) (4)professional products(b) (4)(b) (4)PROJECT MANAGEMENT (WBS 1.1.1)The Contractor shall provide for the following as outlined below:The overall management, integration and coordination of all contract activities, including a technicaland administrative infrastructure to ensure the efficient planning, initiation, implementation, anddirection of all contract activities;A principal investigator (PI) responsible for project management, communication, tracking,monitoring and reporting on status and progress, and modification to the project requirements andtimelines, including projects undertaken by subcontractors; the contract deliverables list identifies alldeliverables and reporting requirements for this contract.
Project manager(s) responsible for monitoring and tracking day-to-day progress and timelines,coordinating communication and project activities; costs incurred; and program activities.
A BARDA liaison responsible for effective communication with the project officer and contractingofficer.
Administrative/legal staff to provide development of compliant subcontracts, consulting, and otherlegal agreements, and ensure timely acquisition of all proprietary rights, including IP rights, andreporting all inventions made in the performance of the project.
Administrative staff with responsibility for financial management and reporting on all activitiesconducted by the contractor and any subcontractors.
ANALYTICAL STUDIES (WBS 1.1.2). Specific tasks include: preparation of study protocols,execution of studies and preparation of study reports for limit of blank, limit of detection, precision,reactivity/inclusivity, cross-reactivity, potentially interfering substances, specimen matrices, specimenstability, carryover, cartridge stability, flex studies, cartridge shipping stability, QC controls, other studiesas required or requested by FDA in support of 510k clearance. Deliverable is a report for each analyticalstudy.
CLINICAL (WBS 1.1.3):In support of 510k clearance(b) (4), Cue will conduct clinical studies to generate data for:Repeatability/Reproducibility at external clinical sitesDetection of Samples at the Limit of Detection at clinical sitesPage 1 of 4

Method Comparison of (b) (4)Influenza to a predicate FDA-cleared Influenza A/B NAT assaywith enrolled subjects (b) (4)atclinical sites in a simulated at-home environmentIn support of 510k clearance for the professional POC/CLIA Waived claim, Cue will conduct clinicalstudies to generate data for:Repeatability/Reproducibility at external clinical sites (same study as for OTC claim)Detection of Samples at the Limit of Detection at clinical sites (same study as for OTC claim)Method Comparison of POC/CLIA Waived Cue Influenza to a predicate Influenza A/B NAT assaywith professional untrained operators testing enrolled subjects (includes parent testing his/her child)Further description of the studies that will be conducted as part of the clinical validation of Cue Influenzaat external clinical sites is presented below.
WBS/IMS Task 1.1.3.6: Clinical Study Protocols, Statistical Analysis Plans, Data ManagementPlans and eDatabase. Specific activities include preparation (b) (4)POC/CLIA Waived MethodComparison, Reproducibility/Repeatability Study, and Samples at LoD Study Protocols (WBS 1.1.3.6.1);preparation of Statistical Analysis Plans (WBS 1.1.3.6.2); preparation of Data Management Plans(DMPs)POC/CLIAand eDatabases (WBS 1.1.3.6.3 1.1.3.6.4). Deliverables are internal approval of (b) (4)Waived Method Comparison, Reproducibility/ Repeatability Study, and Samples at LoD Study Protocols,SAPs, and DMPs, and live eDatabases.
WBS/IMS Task 1.1.3.7 1.1.3.8: Clinical Study Site and Central Lab Qualification and Selectionfor Method Comparison, Reproducibility/Repeatability, and Samples at LoD Studies. Specificactivities include: development of site feasibility questionnaire, identification of potential sites, executionof non-disclosure agreement with potential investigators, conduct site qualification visits and reporting(WBS 1.1.3.7.1 1.1.3.7.8 and WBS 1.1.3.8.1 1.1.3.8.8).Deliverables are at least 16 clinical sites (8sites for OTC and 8 sites for POC/CLIA Waived).
WBS/IMS Task 1.1.3.9: Clinical Study Site Contracts. Specific activities include: draft budgets andbudget negotiation (WBS 1.1.3.9.1); draft contract and contract negotiations (WBS 1.1.3.9.2).
Deliverables are clinical study contracts executed with clinical sites and central lab.
WBS/IMS Task 1.1.3.10: Institutional Review Board (IRB) Submissions and Approvals of EachClinical Validation Protocol. Specific activities include selection of IRB, completion of IRB protocolsubmission forms, draft informed consent forms, and submission and approval of method comparisonstudy protocols and informed consent forms (WBS 1.1.3.10.1 1.1.3.10.4). Deliverables are IRBapproval (b) (4)POC/CLIA Waived Method Comparison, Reproducibility/Repeatability Study, andSamples at LoD Protocols.
WBS/IMS Task 1.1.3.11: Clinical Study Materials. Specific tasks include: ship Cue IUO devices,mobile smart devices, predicate devices and sample collection kits procurement and accountability atclinical sites (WBS 1.1.3.11.1 1.1.3.11.7). Deliverables are all clinical study materials at the clinicalsites.
WBS/IMS Task 1.1.3.12: Clinical Site Initiation. Specific tasks include: preparation of ClinicalMonitoring Plans, set up of Trial Master Files and Investigator Site Binders, creation of study- specificforms, conduct initiation visits and preparation and approval of initiation visit reports (WBS 1.1.3.12.1;1.1.3.12.2.1 1.1.3.12.2.12). Deliverables are clinical sites initiated.
Page 2 of 4WBS/IMS Task 1.1.3.13.1 1.1.3.13.4: Clinical Sites Reproducibility/Repeatability StudyConducted and Reported. This study will demonstrate the reproducibility and repeatability of the CueInfluenza Cartridge assay. This study will be conducted at 3 external CLIA Waived clinical sites with 6trained professional operators using identical panel members. The sample panel will contain 10 panelmembers. Two strains of influenza A virus and 1 strain of influenza B virus will be used to build thepanel members. The influenza A virus panel members will contain high negative (<LoD; C20-80), lowpositive (LoD; C95), and moderate positive (2-3x LoD; C100) concentrations. The influenza B viruspanel members will contain high negative (<LOD; C20-80), low positive (LoD; C95), and moderatepositive (2-3x LoD; C100) concentrations. One panel member will be negative for influenza A and Bviruses. At each site, 2 operators per day will conduct testing and each operator will perform one run perday. Each operator will test 3 replicates of each sample panel per run. Each site will conduct testing for 5days. Each site will generate 30 results per sample for a total of 90 results per sample overall. Statisticalanalysis will include calculating percent agreement (compared to expected results based on panel memberconcentration) by panel member, by site and overall. Subtasks include: study execution (WBS1.1.3.13.1.1 - 1.1.3.13.1.4); database lock, data review and analysis (1.1.3.13.2.1 1.1.3.13.2.8); studyclose-out (WBS 1.1.3.13.3.1 1.1.13.3.2); preparation of study report (WBS 1.1.3.13.4.1 1.1.3.13.4.5).
Deliverable is reproducibility/repeatability study report.
WBS/IMS Task 1.1.3.13.5 1.1.3.13.7: Clinical Sites Testing of Samples with InfluenzaConcentrations near the LoD Conducted and Reported. This study will demonstrate the performanceof Cue Influenza Cartridge with untrained professional users testing samples with influenza virusconcentrations near the limit of detection. The study will be conducted at 3 external CLIA Waivedclinical sites. Cue will prepare a contrived weak positive (C95) sample pool and a contrived weaknegative (C5) sample pool for 2 influenza A strains and 2 influenza B strains (one from each lineage)detected by Cue Influenza and distribute aliquots of the pools to the sites for testing. At least 2 untrainedoperators at each site will conduct testing. For weak positive samples, the percent of Cue Influenzapositive results will be calculated overall and by site. For weak negative samples, the percent of CueInfluenza negative results will be calculated overall and by site. Specific activities include: studyexecution (WBS 1.1.3.13.5.1 1.1.3.13.5.4); database lock, data review and analysis (WBS1.1.3.13.6.11.1.3.13.6.8); study close-out (WBS 1.1.3.13.7.1 1.1.13.7.2); preparation of study report (WBS1.1.3.13.8.1 1.1.3.13.8.5). Deliverable is Samples at LoD study report.
WBS/IMS Task 1.1.3.14: OTC and POC/CLIA Waived Method Comparison Studies.
The OTC and POC/CLIA Waived Method Comparison Studies will establish the clinical performance ofthe Cue Health Monitoring System with Cue Influenza Cartridge and Cue Health. Mobile Applications incomparison to a predicate influenza A/B NAT assay. The prospective, noninterventional methodcomparison studies will be conducted in parallel at a minimum of 10 US clinical sites. Participating siteswill enroll subjects for (b) (4)POC/CLIA Waived studies; however, no subject mayparticipate in both studies. The study population will include subjects of all ages with signs and symptomsof influenza virus infection. (b) (4)(b) (4)subjects (both adults and children) with Cue Influenza and the Cue Professional Mobile App to generatedata in support of the POC/CLIA Waived claim. All predicate assay testing will be conducted by aprofessional trained operator in a CLIA Waived environment. The overall sample size is dependent oninfluenza prevalence during the clinical study, which varies by season, year and influenza type. Theoverall sample size across (b) (4)POC/CLIA Waived studies is approximately 4000 subjects,assuming a prevalence of approximately 5.5% for influenza B virus, to obtain a minimum of 220 samplesPage 3 of 4

positive results for influenza A, 220 samples with positive results for influenza B, and 220 samples withnegative results. Cue Influenza results will be compared to the predicate method (e.g., FDA-clearedinfluenza A/B NAT assay) and positive and negative percent agreement will be calculated. Specificactivities include: study execution (WBS 1.1.3.14.1.1 1.1.3.14.1.6); database lock, data review andanalysis (WBS 1.1.3.14.2.1 1.1.3.14.2.10); study close-out (WBS 1.1.3.14.3.1 1.1.14.3.2); preparationof study report (WBS 1.1.3.14.4.1 1.1.3.14.4.5). Deliverable is method comparison study report.
WBS/IMS Task 1.1.3.15: BIMO Inspections. Specific activities include clinical site and Cuepreparation and mock inspections (WBS 1.1.3.15.1 1.1.3.15.2). Deliverable is mock BIMO inspectionscompleted.
REGULATORY (WBS 1.1.4):WBS/IMS Tasks 1.1.4.1 1.1.4.3: Regulatory Submissions. Preparing and submitting FDA 510k forCue Influenza (b) (4)FDA 510(k) for Cue Influenza POC/CLIA Waived claim. Deliverables areFDA (b) (4)POC/CLIA Waived submissions and clearances.
WBS/IMS 1.1.6.13: Manufacture of Cue Influenza Cartridges for analytical and clinical validation.
Manufacture of at least 3 lots of Cue Influenza Cartridges for analytical and clinical validation.
WBS/IMS 1.2.8: Quality: Maintenance of ISO 13485 certification, quality audits, instrumentcalibrations, QA and release batch records, design control records, oversee building management and anyother records as required.
WBS/IMS 1.2.9 Operations: ERP, purchasing, supply chain and inventory management,production/quality team coordination.

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