Questions and answers 1. Can this study be conducted in our preclinical facility in China? Response-No, location must be within the United States. 2. Does this toxicity study require GLP? Response-No 3. The solicitation states that monkeys will be lightly sedated with ketamine (10 - 20 mg/kg, im) for the 0 time blood and urine sample collections and oral dosing. Is this a requirement that will affect comparisons of the data collected with past study data? If not, would it be acceptable to use a restraint chair for these procedures including gavage as is typically done in NHP facility? Response- This is acceptable. 4. For the 3rd study, we have concerns with sedating and isolating the neonatal males. Is this a requirement that will affect comparisons of the data collected with past study data? If not, we recommend that on the day of dosing the dam should be lightly sedated to facilitate hand capture of the neonate. While the animal is manually restrained a urine sample can be obtained via catheterization, the animal can be bled via the femoral vein, and the dose can be administered via orogastric or nasogastric gavage. The neonate would need to be recaptured multiple times for the blood collections and returned to the dam immediately after each timepoint. The dam will likely have to be lightly sedated multiple times during the day (see #3 above). After the 24 hour blood collection a second urine sample can be obtained via catheterization. Would these procedures be acceptable in place of those requested in the solicitation? Response-This is acceptable.

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