Common use of Efficacy Clause in Contracts

Efficacy. We will assess the difference in number of the percentage of females surviving between release and non- release treatments, as well as how survival is affected by the following variables: • Release rate (the number of male adults released/exiting a single mosquito rearing box) • Trap distance (how far the trap is from the point of release) • Site (which site replicate is being measured) We will assess the difference in female survival between release and non-release sites using general linear mixed-effects models (GLMM) with the random effect of site, a crossed random effect of trap distance, and the covariates life stage and release rate. The model will use a quasibinomial distribution and a logit link function since the response variable is recorded as a percentage. Percent efficacy and 95% confidence intervals will be calculated from the results of the GLMM. The efficacy (E) of OX5034 to kill female mosquitoes is calculated using an adaption of ▇▇▇▇▇’s formula: E=100*((C-T)/C) or E=100*(1-T/C) E = percentage efficacy in individual ovitraps from the treated area. C = percentage of untreated females surviving across all ovitraps in control areas. T = percentage of treated, i.e. fluorescent females surviving in individual ovitraps. Persistence Monitoring The ▇▇▇▇▇▇-▇▇▇▇▇ estimator will be used to characterize the persistence of the OX5034 gene in release sites. Estimated median values, 95% confidence intervals, interquartile ranges and maxima will be reported. It is anticipated that trial(s) will be initiated in 2020, pending regulatory approval, and that OX5034 trials will be completed within 24 calendar months of initiation.

Efficacy. We will assess differences in the difference in number of the percentage numbers of females surviving between release and non- non-release treatments, as well as how survival is affected by the following variables: • Release rate (the number of male adults released/exiting a single mosquito rearing box) • Trap distance (how far the trap is from the point of release) • Site (which site replicate is being measured) We will assess the difference in female survival between release and non-release sites using general linear mixed-effects models (GLMM) with the random effect of site, a crossed random effect of trap distance, and the covariates life stage and release rate. The model will use a quasibinomial distribution and a logit link function since the response variable is recorded as a percentage. Percent efficacy and 95% confidence intervals will be calculated from the results of the GLMM. The efficacy (E) of OX5034 to kill female mosquitoes is calculated using an adaption of ▇▇▇▇▇’s formula: E=100*((C-T)/C) or E=100*(1-T/C) E = percentage efficacy in individual ovitraps from the treated area. C = percentage of untreated females surviving across all ovitraps in control areas. T = percentage of treated, i.e. fluorescent females surviving in individual ovitraps. Persistence Monitoring The ▇▇▇▇▇▇-▇▇▇▇▇ estimator will be used to characterize the persistence of the OX5034 gene in release sites. Estimated median values, 95% confidence intervals, interquartile ranges and maxima will be reported. It is anticipated that trial(s) will be initiated in 2020, pending regulatory approval, and that OX5034 trials will be completed within 24 calendar months of initiation.