ACC-APG-Natick MCM CSO Annoucement QA Final.pdf

Question Government Response Do the Contracting Office and JPEO anticipate use of multiple Fill Finish providers for this program?

Yes.

Proposals containing Technical and Business Volumes were provided to BARDA for this effort in

May, 2020. Will the CSO require a different approach including formatting for the proposals or will an identical or similar approach be pursued?

Prior to DoD assuming this requirement, it was issued under a Letter RFP from BARDA. The AoI that will be posted will require a similar approach and proposal format.

Has the Contracting Office seen the proposals submitted to BARDA by the potential Fill Finish providers?

The proposals previously submitted under the Letter RFP have been provided to ACC-APG-Natick but the

Contracting Officer has not reviewed them since new proposals will be submitted against the CSO AoI.

What is the anticipated timeline for selection of Fill Finish providers?

The government anticipates awarding contracts expeditiously. The government anticipates the AoI will initially require prompt submission of Solution Briefs for evaluation. Upon prompt evaluation of Solution Briefs the government may request proposals baesd on the individual merit of each Solution Brief. The government intends to award as many contracts as required to meet the mission taking into consideration the time needed to evaluate the proposals as well as requirement levels and funding. Contracts will be awarded individually and as soon as the discussions and administrative activities are completed.

What is the anticipated timeline for technical discussions with the bulk vaccine provider?

Due to the urgent nature surrounding this requirement the government will be expecting quick turnarounds on submissions. The timelines are still being finalized, therefore the government cannot provide an exact answer to this question at this time. Evaluations and technical discussions may commence expeditiously upon receipt of submission, but may vary based upon each offerors date and time of submission and the urgency of the current need.

Is there an anticipated time horizon for use by the USG of the reserved filling slots?

The expected time period for government reservation of the capacity is August 2020-December 2021.

Question Government Response Is there any further understanding of Fill/Finish facility capabilities required for anticipated or potential vaccine and therapeutic candidates?

The vaccines being targeted in Operation Warp Speed are committing to produce significant number of doses by the end of 2020 and into the first half of 2021. For single dose vaccines, it is anticipated that 300M doses will be needed. If the vaccine is a 2 dose regiment, the demand may be 600M doses total. This is unknown at this time pending results of clinical trials. Due to the numbers, large formulation/filling batch sizes are expected.

Included in the “capacity” are the costs associated with facilities and equipment usage for a given production slot, labor, materials as well as support services necessary to fill and release a standard batch fill. Please confirm if this CSO is a cost-type contract (i.e., is compensation for cost only?).

Please explain more specifically how the awardee will be compensated – is the intent under the CSO to compensate the awardee for the listed “capacity” costs during the reservation period regardless of whether the capacity reservation is used by BARDA for production?

For this AoI, it is the government's intent to issue Firm Fixed Price Contracts under FAR Part 12, Acquisition of

Commercial Items. It is anticipated that the offerors will propose a solution that includes a reasonable price to hold the reservation. The reservation price would be what the government intends to pay regardless of usage.

Are you anticipating clinical aseptic filling needs with these projects? In other words, smaller batch sizes?

There is a potential for small to midsize commercial batches (50L +), however, at this time, the need for clinical filling appears to be satisfied.