Government_Response_to_KTR_Questions_FINAL.pdf

Government Answers to Questions Provided by Potential Offerors – W81XWH19R0033

Question

Reference Question Answer

1 Is it a requirement for the prime offeror to also be the sponsor of the regulatory application or is there a scenario where a subcontractor can be the sponsor? In such a scenario the prime would manage the overall contract, oversee the subcontractor, and take part in all FDA communications.

The prime offeror is required to be the regulatory sponsor.

2 Is it expected that this will be strictly a tech transfer from the previous program or is there flexibility to re-evaluate certain process steps?

It is desirable to do a tech transfer to minimize impact on the program; however the Government will evaluate any proposed changes as part of the evaluation process. Any changes will need to be agreed upon by

FDA.

3 Are there CPPs available from the previous program that could be used as reference material? If so, can you estimate the quantity of CPPs available?

Sufficient CPP units are not currently available to be used as reference material but efforts will be made to produce additional units (quantity TBD).

4 Has the Human Research Protection Office (HRPO) already approved the Phase 2 study as agreed with FDA?

This would impact our clinical timelines.

HRPO has done a pre-review of the protocol but the protocol was not approved by an IRB or

HRPO.

5 Have stability studies been performed at accelerated conditions? We'd like to know if there is available data that can be leveraged for the 1 year at -30C shelf-life objective

Yes, studies have been performed at the -30C shelf-life objective. The data does not currently support a -30C shelf-life.

6 CPP

Development Summary, page 2, Potency Marker Assay, 2nd

The statement is “Additional methods of potency assessment may be viewed as favorable.”

Should development of additional Potency Marker Assays be included as part of

If additional methods of potency are required after further discussion with the FDA, the contract can be modified to include the additional work. At this paragraph, 2nd sentence the SOW for CLIN0001 or as a potential OPTION?

time there is no requirement to include this development work in the Offeror’s proposal.

7 CPP

Development Summary, top of page 3, Shelf Life/Stability, end of 1st paragraph.

The Government states, “Moving forward, the Government intends to explore increasing the stability to 5 years.” Should this activity be included as part of the SOW for CLIN0001 or as a potential

OPTION?

It is recommended that the stability be included as part of the SOW and not as an option.

8 CPP

Development Summary, pages 3 and 4, Shipment and Storage.

The statement is:

“At this time, the Government still needs to evaluate specialized freezers for military use of CPP.

Accelerated fielding of CPP would likely be dependent on freezers already in the military system. Training for product handling at combat support hospitals (Role 3), forward and resuscitative surgical team, blood support detachments (Role 2), or anywhere else that the product is envisioned to be delivered and used does not fall outside current skill sets of army blood bankers and technicians.”

Should the selection of freezers, deployment methods, storage details, and development/delivery of training be included as part of the SOW for CLIN0001 or as a potential OPTION?

The Government will evaluate the selection of freezers independently of this effort. Information regarding any required storage, shipping, and training activities should be placed in the SOW for CLIN 0001 and not as an option.

9 RFP Page 15, paragraph 6, Optional Task (paragraph 6).

Total LRIP pricing for 1,500 units of CPP is challenging to predict from the vantage point of 2019 market conditions.

Doing so today would necessitate risk-based pricing that may set a much higher negotiating bar than if the

The Government understands that pricing can be difficult years in advance;

however, after discussion with the Government’s technical experts, it was determined that pricing these items should not be a options remained unpriced at this juncture. Would unpriced options be a better approach to avoid risk-based pricing and avert challenges in determining cost reasonableness?

significant challenge for Offerors. These items have been priced before in the previous contract. In addition, at the time the option(s) is/are exercised, the Government will ensure that the proposed prices are still fair and reasonable.

10 RFP Page 19, Deliverable 1.

The Phase 2 trial will involve multiple clinical sites from whom we will need to receive monthly invoicing. In our experience, providing a progress report that includes financial expenditures 5 days after the start of the month will necessarily result in an incomplete financial picture.

This is because sufficient time will not have elapsed to receive, review, and approve subcontractor invoices, bill the Government and include this invoicing as the previous month’s expenditures. The result will be that progress reporting will always be out of synch with actual financial expenditures. Can the Government change the due date to the 10th of the month instead of the 5th?

The language for Deliverable 1 (page 19 of the RFP) has been updated.

11 RFP Page 20, Deliverable 2, Spend Plan

Under the “Subsequent” column, we do not see how a Spend Plan is a reflection of task progress and percentage of work completed, nor how it could be calculated to provide this information. For example, some of the services provided may require upfront funding, and these services provide support throughout the contract period of performance. Such spending

The language for Deliverable 2 (page 20 of the RFP) has been updated.

would reflect progress against all tasks, not just one. In our experience, spending, even on labor, is not a reliable indicator of progress toward work completion so much as it is an indication of contract burn rate. Can subsequent submissions of the Spend Plan be changed to: “Updated quarterly every three (3) months to show costs expended versus funded?”

12 RFP Page 22, Deliverable 8.

There are technical data that may not be deliverable within 5 days of a Government request. For example, some data may take much more than 5 days to develop, and cannot be provided until sometime after a dependent event or milestone. This requirement sets up the potential for compliance problems depending on the type of data involved. Data submittals should be logically linked to program progress, milestone achievements, and program milestones. Can the Government change the submittal requirement to “as negotiated in the contract” or make reference to another planning document, such as the current IMS?

The language for Deliverable 8 (page 21 of the RFP) has been updated.

13 RFP Pages 51 and 54, Proposal Submission Formatting

Page 51, 5th paragraph requires 12-point Arial or Times New Roman fonts. Page 54, Volume II – Technical Volume, 2nd paragraph requires a 10-point Times New Roman font. As the SOW is a subsection of Volume II that also includes the Technical Approach, does only the subsection that

Yes, only the Statement of Work should be Times New Roman and 10-point font.

includes the SOW need to be in font size 10?

14 Attachment 3 OCI Certification, page 2, 1st bullet

This requires Offerors to “Perform a comparative analysis of the potential new work against all current and previous work performed in support of MRMC in any category. The comparative analysis must be included in the proposal for the new work, and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI.” Please identify what else this analysis should contain, at a minimum, to meet the Government’s needs. The contents of the analysis are not specified beyond the certifying statement. Is it correct that the requirements for and contents of the comparative analysis are addressed in the solicitation at page 8-9?

Yes, please review the OCI section on pages 8-9.