QUESTIONS_AND_ANSWERS-Amd_0001-Attachment_1_(2-5-15).pdf

RFP: 15-100-SOL-00003 Question due date: January 28, 2015

Medical Countermeasures for Pandemic Influenza Preparedness and Response (Stockpile 2015)

Questions and Answers

1. RFP p.70 L.6.a.2.I BUSINESS PROPOSAL states “It is recommended that the business proposal consist of a cover page*, a table of contents, and the information requested in the Business Proposal Instructions and as specified in SECTION J, List of Attachments. Regarding the list of Attachments in Section J, A. Is it BARDA's intention that the attachments in Section J be part of the appendices?

B. Can these attachments be exempted from the page counts?

Answer: Yes, the attachments referenced in Section J, notably the Subcontracting Plan and Past Performance Questionnaires submissions may be exempt from the page count. Reference page 78, the listing of the five (5) contracts completed in the past three (3) years may also be exempt from the page count.

2. RFP p.70 L.6.a.2.I BUSINESS PROPOSAL states “Also, include the Offer Submission Package (OSP) for the RFP, whose page number count does not count towards the 26 pages max of offeror’s business proposal.” Do we submit this in the same binder as the business proposal?

Answer: Yes, please submit the OSP in the same binder, along with your business proposal.

3. Regarding Business Proposal page count, from RFP Business Proposal Instructions, L.1 in table, page 63: "NTE 14 Double-sided and 6 Double-sided for Appendices.”

L.6 in first paragraph, p.69: "Business proposals should be no more than 26 pages (14 double-sided pages).”

The page counts for the business proposal and business proposal appendices are very limited. Would you allow the following be placed in the appendices and exempt from page count: Subcontractor Commitment Letters, Offeror's Annual Financial Report, and Front Matter including Acronym List?

“Front Matter” includes the title page, cover page, table of contents, and list of figures. We are wondering if we can also include the acronym list in the “Front Matter” section and have it be exempt from the page count.

Answer: Acceptable, Subcontractor Commitment Letters, Offeror’s Annual Financial Report, and Acronym List, may be included in the appendices and excluded from the page count.

4. RFP p. 69, L.6. Instructions to Offerors, General AND p. 74 Personnel "Include, in an attachment, curricula vitae of supervisors and key technical personnel, and the approximate percentage of time each will be available for this program.” Is this 'attachment' part of the technical appendices and counted against the page count for the technical appendices?

Answer: Yes, please include the curricula vitae as part of the technical appendices.

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Questions and Answers

15-100-SOL-00003

Medical Countermeasures for Pandemic Influenza Preparedness and Response (Stockpile 2015)

5. RFP page 80, M.1 Mandatory Eligibility Criteria contains this note: “Note: Failure to adequately document compliance for either of the above mandatory requirements will result in the elimination of the Offeror’s proposal from further consideration.” To adequately document compliance, we would like to provide our original license approval letter and several supplemental approval letters. Would you consider exempting these regulatory licensure documents from the page count of the appendices?

Answer: Acceptable, documentation supporting adherence toward Mandatory Eligibility criteria will not go towards technical page count.

6. Regarding the requirement for single Gantt Chart found on RFP p. 69 and p. 73

From p. 69:

For all CLINs

Offerors are not required to provide pricing to CLINs for which they do not have capabilities; Offerors shall be required to provide information on the lack of a specific capability.

The proposal shall include:

A Contractor's Work Plan (CWP) that describes the activities to be performed in response to the RFP requirements and a single Gantt chart to include all activities described in the CWP with a time-phased and task-linked budget specifying activities to be supported by the government. The level of detail contained in the CWP and the corresponding Gantt chart should be sufficient to facilitate management and execution of the contract by the successful Offeror(s)."

We understand the requirement for a single Gantt chart to be for all CLINs, in addition to the requirement for a separate one for each CLIN, and not just for the priced CLINs 0001-0007 and 0009.

A. Is this understanding that an additional single Gantt chart (with sufficient detail to facilitate management) for all the CLINs correct?

B. If it is correct, it will be large. May we put it in a Technical Proposal Appendix, instead of in the Technical Proposal itself?"

Answer: Yes to A and B.

7. We are compiling a list of completed contracts. Are five completed contracts in the last three years required? We have one contract in which the deliverables are complete and the final paperwork is under review. May we consider this contract complete?

Answer: Please reference page 78, the offeror shall provide a list of the last five contracts completed during the past three years, and all contracts currently in process. Thus, contract referenced above may be considered current and in process.

8. Offer Submission Package page 15, Section B.3, Turnaround Time

• This specifies "in event of a pandemic".

• Who is responsible for declaring a pandemic event? Can we assume this would be a Pandemic declaration by the WHO Secretary General?

• Table B.3, Column Header: Number of Days Needed from date of Order

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(Stockpile 2015) to Delivery per Maximum Quantity - In order to determine a sustained production capability in the event of a declared pandemic, for planning purposes, what is the assumed duration of the pandemic event?

Answer: For this contract, a pandemic event is defined as a public health emergency declared by US Secretary of Health and Human Services or the President of the United States in response to a disease outbreak cause by influenza. The duration of a pandemic event cannot be predicted; however, for assumption purposed an estimated 6 months will be used. Thus, for purposes of B.3, now named Vendor Production Capacity, duration of a pandemic event is now estimated as six (6) months. See Attachment 3of this Amendment.

9. RFP page 6, CLIN 0001

• This instructs "Provide seed lot samples to the FDA for identity verification, and other testing as specified by HHS."

• Would HHS find it acceptable to submit seed samples to any appropriate governing agency for testing and approval for use in vaccine production?

Answer: FDA/CBER must confirm the antigenic identity and approve all seed used for licensed vaccines or to be used under EUA. FDA/CBER does not test or approve seed for vaccine production to be used under IND; the opportunity to use another appropriate governing agency is acceptable in this case with prior approval from BARDA.

10. RFP page 20, Final Report Requirements Table 1

a. This requires a Certificate of Analysis for Research Lots (CUN 0002)

b. Since non-cGMP research lots do not require an official

Certificate of Analysis, would a summary of assay results be acceptable?

Answer: Yes, a summary is acceptable as long as the assays performed on the research lot are the same as the licensed vaccine or follow instructions and deliverables in the RTOR.

11. Offer Submission Package page 6, CUN 6A-H, Formulation and Filling

• Filling CLINs quote maximum quantity only.

• What are the minimum order quantities?

• Could offerors propose pricing at various quantity levels, up to and including the maximum?

Answer: The quantities will be specified in the RTOR. Offerors can in the proposals define minimum quantities and give technical/manufacturing reasons for minimum quantities with a pricing schedule tied to quantities of vaccine ordered.Minimum quantities apply only for CLIN0006: Formulation and filling.

12. Offer Submission Package page 7, CLIN 0007B, Storage and Stability: Storage of Commercial Bulk Lots of Antigen

• If a contractor is currently storing more than 100 lots, should the maximum

Amendment 0001 – Attachment 1 Page 3 quantity be changed accordingly in their proposal?

Answer: A new CLIN for Storage and Stability of Lots from prior contracts is now added to the RFP and the max quantity in CLIN 0007B will stay 100.

13. Offer Submission Package page 9, CLIN 0015, BARDA Tracking Tool-Development and Testing of New Standard Data Reporting Formats

• CLIN 0015 is "TBD" for this RFP. After award, when does BARDA anticipate issuing an RTOR for this requirement since section F.3.3., Standard Data Submissions, indicates Data Sets are to be submitted to the BTT within 3 months of award?

Answer: The standard data sets identified in Section F.3.3 (page 19 and 21 of the RFP) establish the baseline that are to be submitted within 3 months of award. CLIN 0015 is for the development, testing and reporting of new data sets. Guidance and instructions for new data sets will be provided in the

RTOR.

14. Offer Submission Package page 7, CLIN 0007C, Storage and Stability: Storage of Antigen in Final Container

Different product containers require vastly different amounts of storage space. Can contractors propose separate pricing for different final container presentations, for example, vials vs. syringes vs. sprayers?

Answer: Yes.

15. Offer Submission Package page 8, CLIN 0011, Laboratory Testing/Assay CLIN 0011 is designated as "TBD" for this proposal. However, page 17, table B.5, pricing per time points for various test methods is being requested. This appears to be inconsistent with CLIN 0011 being TBD. Please clarify.

Answer: In table B.5, the type and number of tests is specified and Offerors shall provide costs.

CLIN0011 is a CLIN for generic laboratory assays TBD in the RTOR therefore costs will be provided by the Offerors in response to the RTOR.

16. Offer Submission Package page 78, L.5.g.3, Offeror's Financial Report There is a requirement to include the most recent annual report. Does the page limit in the business proposal include the annual report? For some Companies the annual report alone may be far greater than the page allotment.

Answer: Offeror’s Annual Financial Report may be included in the appendices and excluded from the page count.

17. Since future RTORs will dictate SOWs for CLINs 0008 (Shipping), 0010 (Reagents/Standards), 0011 (Lab Assays), 0012 (Non-clinical Studies), 0013 (Clinical Studies), 0014 (Disposal), and 0015 (BTT) and there are limited guidelines in the RFP as to activities to be performed under these CLINs, please confirm

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Medical Countermeasures for Pandemic Influenza Preparedness and Response (Stockpile 2015) that Offeror's Methodology and Approach should just acknowledge the general requirements for these CLINs and also indicate past experience with doing so. Also, please confirm that no Gantt charts are needed for these CLINs, since the RFP doesn't provide detailed guidelines for these efforts.

Answer: Offerors shall describe their capability to respond to CLINs 0008, 0010, 0011, 0012, 0013, 0014, and 0015 including enough details and information (technical and organizational) to allow the evaluation of the proposal. Gantt charts are not needed for the following CLINs: 0008, 0010, 0011, 0012, 0013, 0014, and 0015.

18. The RFP states that offerors are to provide Gantt charts for each CLIN. CLIN 0016 (Additional Reporting) includes reports with no timing, as well as other reports with timing TBD (inventory, ad hoc, issues involving material, regulatory inspections, etc.). In light of the uncertain timing for many CLIN 0016 reports, please clarify if a Gantt chart is required for this CLIN.

Answer: No Gantt chart is required for CLIN0016.

19. Will bulk adjuvant purchased pursuant to CLIN 0005 be limited to use in combination with antigen provided under this contract or is it envisioned that the adjuvant might be used by the Government more broadly.

Answer: Adjuvant from one Offeror could be used by the Government in combination with antigen from another Offeror (e.g. in influenza clinical studies conducted by the Government or during a pandemic).

20. Under CLIN 0007, Storage and Stability, there is no sub-CLIN for CLIN 0002 Development Lots. Is there a need for such a CLIN?

Answer: No, but if the research lot (CLIN0002) requires stability testing it will be specified in the

RTOR.

21. Pursuant to FAR 52.245-1(h), will the Government bear the risk of loss after acceptance for products stored at the Government’s request? Will Government-directed storage at a successful offeror’s site be deemed to constitute delivery under FAR 52.246-16(b)(2)?

Answer:

Regarding FAR 52.245-1(h), yes, the Government will bear the risk of loss after acceptance. Regarding delivery, even if f.o.b. origin, the contractor will bear the risk of loss in accordance with FAR 52.245- 1(h)(i) , provided contractor provides insurance as specified under CLIN 0008, Shipping.

Reference FAR Clause 52.246-16, page 16, incorporated by reference, and now included in full text.

Please reference sub-paragraph (b) (2): Unless the contract specifically provides otherwise, risk of loss of or damage to supplies shall remain with the Contractor until, and shall pass to the Government upon Acceptance by the Government or delivery of the supplies to the Government at the destination specified in the contract, whichever is later, if transportation is f.o.b. destination.

Thus, risk of loss may transfer at acceptance rather than delivery, if acceptance is later than said delivery.

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Medical Countermeasures for Pandemic Influenza Preparedness and Response (Stockpile 2015)

22. Reference SOW, page 12. For studies under CLIN 0012 (Non-clinical Studies), please clarify if the testing is to be performed in accordance with GLP.

Answer: Non-clinical laboratory studies shall adhere to GLP standards of quality as defined in 21

CFR58.

23. Reference SOW. Potential new CLIN related to Clinical Studies: To expedite our ability to conduct clinical studies in response to pandemic threats, would it be acceptable to HHS to propose a new CLIN to include a plan to prepare a set of shell documents that would be needed to conduct a clinical trial? Shell documents may include a clinical study protocol, consent forms, Investigator brochure, basics of the case report forms and clinical database, IND elements, etc.

Answer: No, this additional CLIN is not acceptable.

24. Reference Solicitation Package. On page 47 of the RFP, Section I.3 is missing. Please clarify.

Answer: Confirmed, numbering typo, there is no Section I.3 in the RFP. Leave other sections numbered as is.

25. The current RFP does not include a CLIN for storage/stability of Antigen or Adjuvant from prior contracts. In [draft SOW] Q&A response #15, HHS indicated that "Storage and Stability of materials transferred from prior contract will be evaluated case by case." Please clarify the terms for storage/stability of material from prior contracts.

Answer: CLIN 0017, with sub-CLINs for Storage and Stability of Lots and Final Containers from prior contracts is now added to the amended Section C, SOW, of Solicitation Package, and B.2., CLIN and Pricing, of Offer Submission Package.

26. Reference Offer Submission Package. In Section B.2., CLIN 0004 cGMP Influenza Vaccine Commercial Scale Bulk Lot(s) estimated maximum quantity is 300. CLIN 0005 cGMP Adjuvant Commercial Scale Bulk Lot(s) estimated maximum quantity is 50. Please clarify if the maximum quantity of bulk adjuvant is sufficient.

Answer: Max quantity for this requirement remains at 50. An Offeror able to handle a higher maximum could indicate such in its proposal or under B.3., Vendor Production Capacity (Attachment 3 of this Amendment).

27. Reference Offer Submission Package. In Section B.2., CLIN 0007B Storage of Commercial Bulk Lots of Antigen estimated maximum quantity is 100 versus CLIN 0004 cGMP Influenza Vaccine Commercial Scale Bulk Lot(s) estimated maximum quantity of 300. Please confirm that this CLIN is for storage of bulk antigen produced under a potential new contract resulting from this RFP and that the maximum quantity is sufficient. Please also confirm that a separate CLIN would be used for storage of material from prior contracts, with maximum quantity commensurate with the volume of material produced under prior contracts.

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Medical Countermeasures for Pandemic Influenza Preparedness and Response (Stockpile 2015)

Answer: CLIN007B is for storage of bulk antigen produced under a potential new contract resulting from this RFP and the maximum quantity is 100. For Storage and Stability of Lots from prior contracts CLIN 0017, with sub-CLINs for Storage and Stability of Lots and Final Containers from prior contracts is now added to the amended Section C, SOW of Solicitation Package and B.2. CLIN and Pricing of Offer Submission Package.

28. Section B.2. refers to CLIN 0002 item name as "Influenza Vaccine Development Lots(s)" and Section C.2.2. refers to CLIN 0002 as "Influenza Vaccine Research Lot(s)." Please confirm item name for CLIN 0002.

Answer: C.2.2, CLIN 0002 "Influenza Vaccine Research Lot(s)” is correct. B.2. CLIN 0002 name is revised to coincide. See Attachment 2.

29. Section B.2. refers to CLIN 0003 item name as "cGMP Influenza Vaccine Clinical Lots(s)" and Section C.2.2. refers to CLIN 0003 as "cGMP Influenza Vaccine: Investigational Lot(s)." Please confirm item name for CLIN 0003.

Answer: CLIN 0003 "cGMP Influenza Vaccine: Investigational Lot(s)” See Attachment 2 for B.2 revision.

30. Section B.2. refers to CLIN 0005 item name as "cGMP Adjuvant: Commercial Scale Bulk Lot(s)" and Section C.2.2 refers to CLIN 0005 as "cGMP Adjuvant: Clinical or Commercial Scale Bulk Lots(s)."

Please confirm item name for CLIN 0005.

Answer: CLIN 0005 "cGMP Adjuvant: Clinical or Commercial Scale Bulk Lots(s)." See Attachment 2 for B.2 revision.

31. Section B.2. refers to CLIN 0012 item name as "Animal Studies" and Section C.2.2 refers to CLIN 0012 as "Non-clinical studies." Please confirm item name for CLIN 0012.

Answer: CLIN 0012 "Non-clinical studies” See Attachment 2 for B.2 revision.

32. Section B.2. refers to CLIN 0007A item name as "Storage of Clinical Bulk Lots of Antigen" and Section C.2.2 refers to CLIN 0007A as "Storage of Investigational Lots of Antigen." Please confirm item name for CLIN 0007A.

Answer: CLIN 0007A "Storage of Investigational Lots of Antigen” See Attachment 2 for B.2 revision.

33. Section B.2. refers to CLIN 0007D item name as "Storage of Adjuvant Bulk Lots" and Section C.2.2 refers to CLIN 0007D as "Storage of Clinical/Commercial Scale Lots of Adjuvant." Please confirm item name for CLIN 0007D.

Answer: CLIN 0007D "Storage of Clinical/Commercial Scale Lots of Adjuvant.” See Attachment 2 for B.2 revision.

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34. Section B.2. refers to CLIN 0011 item name as "Laboratory Testing/Assays" and Section C.2.2 refers to CLIN 0011 as "Analytical Laboratory Testing/Assays". Please confirm item name for CLIN 0011.

Answer: CLIN 0011 "Analytical Laboratory Testing/Assays” See Attachment 2 for B.2 revision.

35. Section C.2.2., CLIN 0016 requirements state that the contractor shall "Inform the CO and COR of all issues involving any of the material managed under this contract within three (3) business days of the incident. An impact assessment and remediation plan shall be provided within twenty (20) business days of the incident."

We request that HHS revise the timing for notification of issues to “within five (5) business days of internal awareness of the incident.” Also, we request that HHS revise the timing for an impact assessment and remediation plan to “within thirty (30) business days of the internal awareness of incident. Lastly, please clarify how HHS defines “issues.”

Answer: The RFP has been revised to: within five (5) business days of internal awareness of the incident.” and “within thirty (30) business days of the internal awareness of incident. If an activity is subcontracted is the contractor’ s responsibility to inform the subcontractor of the timing of notification.

In case of a Public Health Emergency any issue related to the contract must be reported immediately to the Government.

Any issue that have an impact on production, release timing, safety, quality, regulatory, non-clinical and clinical studies, storage and stability and on any deliverable under contract shall be reported to CO and COR within timing for notification as stated above.

36. In Section F.3, Reporting Requirements and Deliverables states the Monthly Executive Summary and Monthly Technical Progress Reports are to be submitted on the 15th of each month and a copy of the reports submitted electronically via e-mail to the COR, CO and BardaTrackingToolInfo@hhs.gov. Please confirm that electronic submission constitutes receipt of the reports.

Answer: The original hard copy submitted [mailed via USPS or courier] to the Contracting Officer (CO) by the 15th of each month constitutes receipt. Submission of electronic copy should also be on the 15th of each month.

37. In Section H.21 BARDA Security Requirements, unless requesting a waiver for this requirement, must Offerors address their ability to meet these requirements in their proposals?

Answer: Yes, reference BARDA Security Requirements, Section I, Security Administration, Item 2, Facility Security Plan, page 39, “. . . the offeror shall submit a written security plan (in their proposal) to the Contracting Officer . . .”

38. Section H.21 BARDA Security Requirements: Can the Government provide additional clarification as to what circumstances would justify requesting and being granted a waiver of the security requirements set forth in Section H.21?

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Answer: If vendor would like to request a waiver to any of the stated BARDA security requirements, the Program Protection Office, BARDA will review the request for acceptance or denial. Along with waiver request, submit a justification letter for review, as stated under Waiver, page 39.

39. Under Section C.2.3, will the Government be responsible for costs associated with placing Government representatives on site to monitor daily activities and facilitate communications between the Government and a successful offeror?

Answer: Yes, but the contractor shall offer at a minimum desk space.

40. Will successful offerors be required to the extent of their capabilities to respond to all Task Order Requests or will responses to Task Order Requests be optional?

Answer: When a RTOR is published a contractor who chooses not to respond will send a communication to the CO stating reasoning.

41. Does the Government anticipate that certified cost or pricing data will be required for proposals submitted under the base indefinite-delivery, indefinite quantity contract [IDIQ], considering the potential extent of adequate price competition, or will certified cost or pricing data only be required as appropriate with respect to specific Task Order Requests?

Answer: While the Government does not anticipate requiring certified cost or pricing data for the base IDIQ; it may request other than certified cost and pricing data in accordance with FAR 15.403-3, Requiring Data Other Than Certified Cost and Pricing Data.

42. Does the Government intend to limit the maximum term of individual task orders? If not, does the Government intend to include in FAR 52.216-22(d) a limitation on the extent to which the period of performance (PoP) under an individual task order can extend beyond the expiration of the base indefinite-delivery, indefinite quantity contract?

Answer: FAR 52.216-22 is incorporated by reference on page 45. Subparagraph (d) is indicated below to state a limitation on the extent to which the PoP under an individual task order can extend beyond the expiration of the base contract as follows:

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after six (6) months of contract PoP end date.

43. Does the Government intend to include FAR 52.247-29 F.O.B. Origin (Feb 2006) in any Task Order Request that requires international shipping?

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Medical Countermeasures for Pandemic Influenza Preparedness and Response (Stockpile 2015)

Answer: Reference Section I.1, FAR 52.252-2, Clauses Incorporated by Reference (February 1998), page 44. Include 52.247-29 – F.o.b.-Origin (Feb 2006).

44. With respect to the Final Reports required under Section F.3, will successful offerors be required to include pictures of all materials in their Final Reports or only pictures of representative samples of materials produced under each CLIN?

Answer: Pictures of all materials shall be included in Final Reports for each Task Order.

45. For CLIN 0016 (Additional Reporting), please clarify if Offeror's are to include a cost for this CLIN or if NSP.

Answer: For CLIN 0016 all additional reports are Not Separately Priced (NSP). See CLIN 0016 under revised B.2., CLINs and Pricing at Attachment 2.

46. Will HHS provide opportunity for Offerors to ask additional questions regarding the RFP beyond 28- Jan-2015?

Answer: No, there will not be any further communications until after receipt of proposal(s), and at such time HHS chooses to conduct negotiations with any or all responsive and responsible offerors.

47. Would HHS consider extending the proposal due date to 27-Feb-2015?

Answer:

Proposal receipt date and time is revised as follows: February 27, 2015, 3:00 PM EST.

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