Primates Questions and answers.doc

Questions and answers:

1. When will you need the first group of monkeys? I ask because Rhesus have a breeding season, they don’t breed all year long. They usually start breeding around August-September.

Answer: We can only receive up to 20 animals at a time but we would like to get shipments of 20 at the same time if possible. It would be preferable to get the animals early enough in their pregnancies to be able to get them through quarantine (6-8 weeks) by gestational day 125 or so but I am afraid that might be a prohibitive request since that would mean we would have to take receipt of the animals when they were only about 1 to 2 months into their pregnancy. So, ideally we would want animals delivered to us by the end of the second month of pregnancy (gestation day 60 or so) but we would take animals as old as 90 to 100 days into their pregnancies.

2. The RFQ seems to indicate one shipment of 10 and one shipment of 11 pregnant rhesus, but below this it states that you may get up to 50- is this something that will be determined as the study progresses or will you need 50?

2.1.3 CLIN0001 FY 10, Rhesus Monkeys

EA:____________

2.1.4 CLIN0002 FY 11, Rhesus Monkeys EA:____________

2.1.5 CLIN0003 Shipping round trip, Rhesus Monkeys

EA___________ Total order not to exceed 50 time dated pregnant females (29 male fetuses and 21 female fetuses) Answer: The FY 10 and 11 are for Fiscal Years meaning that this fiscal year is before September 30, 2010, and next fiscal year is after October 01, 2011

3. What is the time line for this work to be completed? When would the first shipment of monkeys be required? The SOW states that delivery date is of utmost importance, and we need to understand the FDA's expectation and timelines.

Answer: See question 1 above.