RFP Q&A.docx

RFP Questions and Answers

Ownership:

Q. Could you please confirm that during the replacement period as mentioned in D2, USDA would relinquish all rights to the rejected VAC and the manufacturer does not have any requirements to maintain rejected VAC in storage?

A. As soon as VAC is directed to be replaced, USDA relinquishes all rights to the rejected VAC. There are no requirements to further store this VAC.

Q. We understood clearly the performance period (from T0 until the end of the guaranteed shelflife), however, could you please confirm that at the end of the performance period of each VAC, if the USDA does not order the formulation of the remaining VAC into vaccines before the end of the performance, the manufacturer will take over the ownership of the VACs and will engage its responsibility regarding their final destination. The USDA will relinquish its rights on the VAC at the title transfer back date. This provision shall be clearly mentioned in the Contract as in the proposed RFP, USDA will be the owner of the VAC stored in our premises and the manufacturer will not be liable to continue the storage and the formulation after the end of the performance period.

A. USDA maintains ownership of the VAC in storage until the end of the guaranteed shelf life. During the ownership period, USDA has full rights for VAC disposition. At the conclusion of the guaranteed shelf life, ownership of any VAC remaining in vendor storage will revert to the manufacturer.

Shipping:

Q. Our understanding is that the request is to quote for a price of conversion of VAC into vaccines that shall include the price of shipment and insurance to be organized by the vaccine supplier until an international airport in the US, while the FOB Incoterm implies that USDA will organize and pay for the shipment. Can you please clarify? Again we would recommend to use the CIP Incoterm to avoid any inconsistency between the Incoterm selected and the provisions of Section C4 (all shipping and delivery costs associated with delivery of finished vaccine to any international airport in the U.S, as designated at time of order, shall be included in the unit price of the VAC conversion cost).

A. Incoterms are not mentioned or incorporated in the RFP. FOB Destination per the definition provided in the RFP is required. This implies vendor is responsible for the material until delivered to a U.S. International Airport identified at time of order for conversion. All costs associated with transportation to the destination to include any customs or VAT taxes are the responsibility of the vendor.

Target Species:

Q. The RFP seems to be exclusively focused on Cattle FMD Vaccines. We understood that FMD vaccines were multiple species were under consideration from our previous conversations. Is the government still pursuing FMD vaccines for swine?

A. The RFP states NAVVCB conducts safety and potency tests in cattle; it does not indicate target species claims. Ideal vaccines will be suitable for vaccinating multiple species against FMD. If needed, the vaccine will likely be used in cattle and swine, and depending on the outbreak conditions may be used in small ruminants and zoo animals.

Target Serotypes:

Q. Assuming that the desired annual vaccine quantities(1m or 2.5m+) are serotype specific, would you like respondents to submit separate proposals for different serotypes that they can address for a given species or can they be submitted in the same proposal?

A. The RFP requests fixed pricing for all FMD VAC types offered by the manufacturer. This means only one proposal shall be submitted. The Offeror shall submit serotype specific information that indicates safety and efficacy for a given species; all data shall be submitted in one proposal. The Offeror must provide the NAVVCB with a list of master seed viruses (MSV) that have been tested and approved by APHIS for use in production, and a separate list of MSV which are used to prepare commercial vaccines but have not been approved by APHIS (see Technical Annex, F.2.1).

Acceptable Manufacturing Sites:

Q. Please re-confirm that our manufacturing site in Taiwan would be acceptable for production?

Additionally what would be your position on API manufacture at a US facility and Vaccine formulation at a Taiwan facility?

A. CVB is the regulatory body that would make this determination. We will not confirm whether your facilities meet CVB requirements prior to receipt of a proposal. We would direct you to your CVB reviewer for questions.

Registration Progress:

Q. What are the requirements of the challenge for swine species, specifically are 1 or 2 inoculations acceptable?

A. Contact the CVB Reviewer assigned to your company.

Q. We have submitted the application for FMDV license with CVB, how far a long do we need to be in the submission process in order to be considered and what testing will be required from us at this time?

A. Contact the CVB Reviewer assigned to your company.

Q. Will real-time stability be required to establish (guarantee) the shelf life or will accelerated studies be acceptable?

A. Contact the CVB Reviewer assigned to your company.