Amendment 0003 to RFP-12-100-SOL-00026.pdf

RFP-12-100-SOL-00026 Page 2 Amendment #3

SECTION I - CONTRACT CLAUSES

The following section is hereby modified to the following:

I.1. Federal Acquisition Regulation (FAR) (48 Chapter 1) Clauses

The following clause is hereby added to the solicitation:

Reg Clause Date Clause Title

FAR 52.227-14 DEC 2007 RIGHTS IN DATA—GENERAL (Alternate II)

RFP-12-100-SOL-00026 Page 3

Anthrax Antitoxins for the Treatment of Inhalational Anthrax

RFP-12-100-SOL-00026

Questions and Answers

QUESTION 1:

Our question is regarding the government’s objective for acquiring a master cell bank under solicitation RFP-12-100-sol-00026. On one hand it would make sense that the government would want a master cell bank that could produce one of the products to be procured. However, the way the SOO is written, the requirement for the delivery of the master cell bank only requires a TRL 6B and not at the pre-EUA level. Would the government accept delivery of a master cell bank that does not produce a product that meets the objectives for FDP delivery?

RESPONSE 1:

Yes, the USG will accept a cell bank that does not produce a product that meets the objectives for the rest of the CLINs. The USG has made significant investment into the development of several products and this CLIN is intended to mitigate the risk of loss of USG access to the cell bank from which the product is made.

QUESTION 2:

We have a minor format question regarding the content of the Risk mitigation plan. I had a minor format question regarding the content of the Risk mitigation plan.

· Per Page 79, L.21. A risk mitigation plan. The risk mitigation plan should address potential problems that may arise and remediation plans to circumvent major time disruption to the project. Each of these documents can be revised during negotiations with the successful Offeror and will be incorporated into the contract. The risk mitigation will be finalized 90 days after contract award.

· Per page 52, Risk Mitigation Matrix

Is it appropriate if we use a risk mitigation plan that uses a template with the following categories such as:

· WBS #

· Key Activity Area

· Potential Risk

· Probability of Occurrence

· Severity

· Risk Score

· Planned Mitigation

· Status

RESPONSE 2:

Yes, the template proposed is acceptable.

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QUESTION 3:

In Amendment 2, BARDA stated that it would provide AVA "to all successful offerors that receive a Task Order award for collection of human immune plasma." Please confirm the provision of AVA by BARDA to contractors includes not only CLIN 0004, but also CLIN 0002 and CLIN 0006.

RESPONSE 3:

AVA will be provided to support the plasma collection CLIN, it will not be provided to support BDS or FDP manufacturing CLINs or storage or delivery CLINs.

QUESTION 4:

In Amendment 2, BARDA agreed that the Buy American Act (BAA) clause (52.225-1) should be deleted and the Trade Agreements Act (TAA) clause (52.225-5) should be included. BARDA deleted the BAA clause, but did not include the TAA clause in the table on page 10. Please add the TAA clause.

RESPONSE 4:

Under the question in Amendment 2, it stated that the USG agrees (with the removal of the clause) and would remove the clause (52.225-1). The USG did not agree that FAR 52.225-5 Trade Agreements should be included under its response in Amendment 2.

QUESTION 5:

Section L.1 of the RFP provides that an offeror's technical proposal will be incorporated into the resultant contract. How will BARDA accomplish the incorporation? Will BARD A include an H clause into the awardees' contracts to incorporate their respective proposals?\

RESPONSE 5:

Yes, a provision in Section H of the contract will incorporate (prior to contract award), either partially or in its entirety, the offeror’s proposal into the contract.

QUESTION 6:

B.5.2 states: "When the Government elects to fill a requirement that is estimated to exceed $3,000, the Contracting Officer shall provide a Task/Delivery Order request to the awardees that receive contracts for the particular part for which responses are being solicited." There were several answers to questions on pages 19 and 20 related to this topic that imply ID/IQ awardees can submit proposals in response to RTORs for any CLIN regardless of whether the awardee submitted a proposal for the CLIN(s) relevant to the RTOR.

It is our understanding that an awardee of an ID/IQ contract may only submit responses to ROTRs for the same CLIN(s) upon which its award was based. The reasons are based on pricing and equal treatment.

With respect to price, (1) the government cannot make a fair and reasonable pricing determination with respect to an awardee that did not compete for a particular CLIN in the initial procurement; and (2) the

RFP-12-100-SOL-00026 Page 5 contractor that did not submit initial pricing for a CLIN would have an advantage over the awardees that submitted prices because the awardees prices would be publicly available by the time RTORs were issued. With respect to equal treatment, (1) BARDA would not have been able to evaluate the contractor's technical solution on a best value tradeoff basis with respect to the other offerors that submitted proposals for particular CLINs; and (2) BARDA would be treating offerors unequally if it were to allow a contractor to respond to an RTOR if it did not meet the minimum requirements at the time of proposal submissions which is required by the RFP.

Please clarify that awardees of an ID/IQ contract may only submit responses to ROTRs for the same CLIN(s) upon which their respective awards were based.

RESPONSE 6:

Please refer to Section B.5 under the RFP. The Federal Acquisition Streamline Act (FASA) requires that each awardee under a multiple award contract be given a fair opportunity to be considered for each order in excess of $3000, unless a statuary exception applies.

The main IDIQ contract will be awarded based on proposals submitted that demonstrate the ability to complete at least one CLIN. After the main IDIQ contract is awarded, Request for Task Order Responses (ROTRs) will go to all contractors awarded an IDIQ contract under this RFP, and proposals will be required for each of the CLINs. This is to ensure competition and provide the USG with the best value. As the RFP is structured, funds will not be obligated under the main IDIQ contract, but will be obligated on TO/DO issued pursuant to the main contract.

QUESTION 7:

On page 15 of Amendment #2 for Solicitation RFP-12-100-SOL-00026 it states “ The technical proposal shall contain an index that cross-links the proposal with the requirements in the SOO and with the Evaluation Factors, to facilitate proposal evaluation by the USG. The technical proposal may not exceed 75 pages with up to 100 additional pages of appendices. Pages shall be numbered consecutively starting with page 1.” We estimate that the table of contents and the index will take up approximately 20 pages.

Would BARDA consider excluding the table of contents and the index from the page count?

RESPONSE 7:

Yes, this is acceptable.

QUESTION 8:

We have a clarifying question based upon your response to a previous question we asked concerning when risk of loss for the frozen BDS transfers to the USG. It is our understanding that, pursuant to FAR 52.246-16, risk of loss for frozen BDS transfers to the USG upon the later of (1) acceptance or (2) delivery to the physical location specified by the USG. In the case of the frozen BDS, the BDS will never be physically delivered to the USG (instead, it will be stored at our facilities). We therefore interpret this to mean that risk of loss transfers to the USG upon acceptance of the BDS by the USG, since delivery will never occur. Can you please confirm that risk of loss for the BDS will transfer to the USG when the USG accepts the BDS?

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RESPONSE 8:

No, if the storage is arranged under a subcontractor with the prime contractor or BDS is stored in the prime contractor’s facility, the risk of loss remains with the contractor even after USG accepts the BDS. The contractor shall maintain all Government Furnished Property in possession of the prime or subcontractor.

QUESTION 9:

In the event the contractor provides its master cell bank to the USG under a task order, is the USG obligated to first approach the provider of said master cell bank if the USG desires to use this master cell bank in order to produce the resulting monoclonal antibody?

RESPONSE 9:

Under this task/delivery order, USG intends only to procure the master cell bank. The cell bank will be used by USG ONLY IF the contractor is unable to provide such service.

QUESTION 10:

What does the USG anticipate receiving in conjunction with the delivery of the actual master cell bank? For example, does the USG anticipate also receiving access to regulatory files, manufacturing know-how, instructions and other related intellectual property?

RESPONSE 10:

All documentation associated with release testing, GMP compliance will be required, but not the actual production batch record.

QUESTION 11:

If the contractor provides a master cell bank and potentially other materials (per the above) to the USG, does the contractor thereby convey full ownership rights and title in the master cell bank and related materials to the government? We note that Alternate 2 and 3 of FAR 52.227-14 are not included.

RESPONSE 11:

No, the USG shall have full ownership. But since USG has no intention to use it, The USG is not negotiating a user fee for that specific task/delivery order. FAR 52.227-14 Alternative II was inadvertently left out of the solicitation, and is being inserted into the solicitation with this amendment.

QUESTION 12:

Given that Alternate II or III to 52.227-14 are not present are we correct to assume that there is no requirement to release our proprietary data to the government?

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RESPONSE 12:

No, 52.227-14 Alternative II was inadvertently left out of the solicitation. It is being inserted into the solicitation with this amendment.