Questions_and_Answers_(Final)_-_Draft_SOW_-Stockpile_2015_(11-21-14)_.pdf

Stockpile 2015 November 21, 2014

RFP: 15-100-SOL-00003

Draft Statement of Work (SOW) Questions and Answers

1. What is the context for issuing an RFI/RFP at this time?

Answer: Allowance for adequate time to solicit, receive offers, evaluate, negotiate, and award contracts before September 1, 2015.

2. When does BARDA anticipate releasing the RFP? Are there any additional important dates to keep in mind?

Answer: RFP Pre-solicitation Notice publication date anticipated: December 5, 2014

RFP publication anticipated: January 12, 2015

3. What insights and direction regarding any new requirements can BARDA share that will be included in the RFP?

Answer: New CLINs

-BARDA tracking tool- Development and testing of New Standard Data Reporting

Format

-Analytical Laboratory Testing/Assay

-Candidate Vaccine Virus preparation

-Potency Reagent and standards manufacture and testing

4. What are the anticipated award evaluation criteria including how cost/price will be considered?

Answer: Evaluation criteria will be similar to the previous RFP-2012. Best value tradeoff

Source Selection. Thus, not necessarily the lowest price nor the highest technically rated offeror will receive award. Technical, Price, and Past Performance, along with Small

Business Plan will be evaluated. Mandatory eligibility criteria are that offeror must hold a

U.S. influenza vaccine license or have developed an influenza vaccine as evidenced by a completed Phase 3 clinical study report and Minutes from a US FDA Pre-BLA meeting.

5. What is the program funding profile?

Answer: A minimum ordering limitation and Government guarantee of one CLIN or

$500,000 to be awarded within one year from contract award date. All other orders for acquisition of Medical Countermeasures will be based on needs for Preparedness and

Response to pandemic Influenza

Stockpile 2015

Draft SOW Questions and Answers

6. What is an approximate contract value and period of performance (five year contract or three year base period plus two option years)?

Answer: Three year base period, with two 12-month option periods.

7. Does BARDA anticipate that CLINs will be Firm Fixed Price or will some CLINs be structured differently, (i.e. cost-reimbursable)? If the CLINs are different, can you indicate which will be CPFF and which will be Fixed Price?

Answer: Firm-fixed price for CLIN0001 thru CLIN000; for CLIN 0008 to CLIN 0015, pricing will be requested using a Request to Task Order Response (RTOR).

CLIN 0008, Shipping, will be at cost with vendor seeking three competitive offers.

8. Are Contractors required to propose on all CLINs for which they have the capability to propose?

Answer: YES. If Contractor has no capability to respond to a CLIN, please explain why.

9. BARDA recently awarded contracts to support a Fill/Finish Manufacturing Network (FFMN) comprised of CMOs to work with vaccines manufacturers. Can you confirm that if a vaccines manufacture has a subcontract with one of the CMO awardees that any manufacturing contract awarded based on the draft SOW will be used as the basis for ordering materials (antigen and/or adjuvant) to be shipped to that CMO?

Answer: Yes- it is the intent that bulk vaccine materials (antigen and adjuvant IF both these processes have been tech transferred into the FFMN already) to be filled by the FFMN would be “purchased” through the stockpile contracts.

a. If the answer to this question is yes, there could be potential gaps between the CMOs’

FFMN contracts and the SOW (e.g., final formulation of bulk antigen, final combination packing of antigen and adjuvant, possibly shipment costs, etc.). Will BARDA fill any gaps in the process with additional CLINs to allow for a complete beginning-to-end process from manufacture to final product?

Answer: The FFMN agreements between the FFMN contractor and the Vaccine manufacturer will specify if Formulation will be done by the FFMN or the Vaccine Mfg. If the Formulation will not be tech transferred to the FFMN and must be done by the Vaccine bulk mfg, an additional CLIN would need to be added to the Stockpile contract. Packaging and shipment activities are already included in the FFMN contracts.

b. If BARDA will not add additional CLINs, is it permissible for offerors to propose additional CLINs to fill any perceived gaps in the process?

Answer: Yes additional CLINs can be included in the proposal for consideration.

10. What will the term of resulting contracts be? For example, in CLIN 0007, an offeror is required to plan for 60 months (5 years) of temperature controlled storage, but also to retain representative samples for storage/stability testing for up to 120 months (10 years); is BARDA considering awarding 10-year contracts (or longer, since it is 120 months from the date of manufacture, not the date of contract award), or will the additional storage and stability up to 120 months be addressed under a later contract mechanism?

Answer: See Response #6 and #11.

11. Will BARDA commit to identifying the complete storage/stability period at contract award? Planning on controlled temperature storage and stability testing can present challenges if storage orders are short term or ad hoc because the manufacturer cannot determine a long-range plan.

Answer: For material manufactured under the new contract, contractors should plan for 10 years of storage/stability of clinical lots, bulk lots and final containers; however, Task Orders for Storage/Stability will be issued on a yearly basis, or less, if not at the beginning of the calendar year, over the length of the contract.

12. Will there be an additional opportunity to ask BARDA questions after the final RFP is issued?

Answer: Yes.

13. General concern: The previous stockpile contracts accentuated concerns about the HHS approach to the public-private partnership, particularly in situation, like H7N9 where rapid response to evolving pandemic threats is needed to address a public health emergency. The contracting process was cumbersome and shifted significant risk to industry for the H7N9 response. The incremental contracting approach, requiring as many as 6 separate contracting actions prior to HHS commitment of a stockpile purchase late in 2013 requiring senior leaders in industry to make difficult decisions about diversion of commercial manufacturing activities for seasonal influence vaccine without any assurance of HHS commitments to an H7N9 stockpile.

Without such risk-bearing decisions by industry, HHS would not have been supplied with the

H7N9 stockpile by the end of 2013, in advance of the 2nd wave of the outbreaks in Southeast

Asia. Further, many of these RTORs had extraordinarily short response times and were followed by extended times for TOR award decisions by HHS.

Answer: HHS will issue, when possible and depending on funding, RTORs containing multiple CLINs to accelerate and streamline the process.

14. Vendor requests that HHS consider a bundled seed-to-stockpile CLIN that would be performance based, e.g., dependent upon agreed upon clinical trial and manufacturing outcomes, that would be more commensurate with shared risk for the public-private partnership?

Alternatively, issuance of RTORs with multiple CLINs is requested.

Answer: See Response #13

15. Required stability program: The SOW requires a 60 Month Stability Program for both bulk and FDP. However, at the time we take samples to support the 60 month initial stability protocol, we’re required to set aside sufficient samples to support stability for up to 120 months.

[CLINs 003 – 007 (pp. 3 – 7).]

Question: We assume the requirements of this CLIN apply to material produced under the new contract. Please confirm. If true, please clarify the stability requirement for bulk and final container material transferred from a prior contract.

Answer: Yes. Storage and Stability of materials transferred from prior contract will be evaluated case by case.

16. Material compliance with internal QC System: The SOW requires us to “Ensure stored materials are compliant with the Contractor’s internal quality control system and are ready for use in further cGMP governed manufacturing of clinical material or licensed doses as directed by

HHS.”

Statement: We acknowledge the need for the requirement to complete secondary processing of unexpired bulk product (antigen and adjuvant) for pre-pandemic and pandemic purposes under the contemplated contract. Our products have expiry dates supported by data; and our internal quality procedures preclude us from processing expired materials. To remain compliant with our internal Quality control system, we normally wouldn’t keep nor forward process expired materials for cGMP manufacturing. To consider using material beyond its expiry date, we would first need approval from FDA/CBER.

Answer: The intention of this requirement is two-fold, 1) to ensure that product stored under

BARDA contract is maintained and monitored under cGMP conditions to ensure product quality, 2) to provide pathway for extension of dating of stored products that maintain product specifications. BARDA agrees that FDA/CBER agreement shall be obtained prior to further use supporting IND, EUA or in accordance with product license.

17. Required regulatory documentation updates to support continued use of stored material: The SOW requires us to “make appropriate updates to the regulatory documentation supporting the continued use of the stored material for pre-pandemic preparation, pandemic response and, where appropriate, manufacture of licensed doses.” [CLIN 007 (p. 7) and CLIN

016 (p. 11)]

Statement: Our products have expiry dates supported by data; and our internal quality procedures preclude us from processing expired materials. Potential updates to regulatory documentation for seasonal, pre-pandemic and/or pandemic products will be considered and evaluated internally. We are unable to commit to making updates to regulatory documentation for any product that are not based on sufficient data.

Answer: BARDA understands that during product development, the manufacturing and testing schemes may change. BARDA’s intention with this requirement is to ensure that the contractor considers the stockpiled product when reporting these changes to FDA, updating the IND, MF, EUA or BLA, for example, to ensure the stockpiled product is maintained within regulatory compliance.

18. Obligation to bridge alternative potency assays to SRID testing: In the case when alternative potency assays are approved by HHS for release because CBER reagents are not available, once reagents become available, potency determination should be bridged to SRID testing. Parallel testing with both assays shall continue for the duration of the stability program.

[Additional Requirements (p. 11)]

Statement: The draft language requires maintaining parallel potency testing in the event alternative assays are initially used due to a lack of CBER reagents. Would HHS accept a potency testing bridging period for some set (TBD) duration in lieu of permanently performing parallel potency testing?

Answer: Contractor can send a different potency testing bridging timelines to be considered.

19. BARDA Tracking Tool and Testing of New Standard Data Reporting Formats: Plan and create new data sets for submission to the BARDA Tracking Tool (BTT) as described by contract and/or RTOR. These are additive to the data sets identified in Section F ‘Reporting

Requirements and Deliverables’ For planning purposes, BARDA is considering the following data sets for new development and testing with the BARDA Tracking Tool and may add other data sets in the future. [CLIN 0015 (p. 9) and Attachment A (p. 19)]

Statement: We acknowledge and support BARDA’s goal of capturing comprehensive data sets which may be used for the purposes pre-pandemic and pandemic planning. During the period of performance of the contemplated contract, will BARDA accept submission of electronic files via email to meet these requirements? While we have the ability to send these files via email, any requirement which would require modification of our Enterprise

Resource Planning (ERP) system to enable automated data transfer would need to be negotiated.

Answer: Yes, BARDA will accept submission of electronic files via email. Contractor may also include modification to existing ERP systems to be considered.

20. Are CLINs 0001 through 0007 mandatory to be priced and proposed with the remaining

CLINs priced and/or proposed at the discretion of the offeror? Please confirm or clarify.

Answer: Offerors must provide prices for CLIN0001 through 0007 however Offerors will not be able to price CLINs 0008 through 0014 due to lack of details and deliverables which will be defined in subsequent issuance of RTORs after contract award .

21. If a Contractor receives a task order for, e.g., production of new materials or stability information is updated based on performance of a stability task order, will a Contractor be required to submit a BLA or supplement a BLA based on that work? If so, would associated regulatory costs and filing fees be reimbursable?

Answer: To be discussed with the Contractor.

22. If a Contractor is required to extract enough samples for 10 years of storage and stability, and the contract is for three years, will BARDA provide a method for reimbursing for continued storage and stability? Or will a contractor be simply required to dispose of any materials under

CLIN 0014 at the end of the contract term?

Answer: HHS will continue to issue Task Orders for storage/stability of stored material for the length of the contract and possibly for future contracts. HHS will communicate to Contractors need to dispose materials is necessary.

23. Will materials from the stockpile contract be expected to be used in mix and match studies, involving potential collaborations for “combination” testing and stability of antigens and adjuvants from separate sources, and potential clinical expertise collaboration or overview?

Answer: Mix and Match clinical studies could still be planned and performed in collaboration with DMID-NIAID, if needed.

Stockpile SOW - Q&A

(Meeting held at BID 2014 - October 15, 2014)

24. Q: Can the timeline be delayed and/or expanded?

A: See Response #2

25. Q: Period of performance is a three year base with two option years, but the contract calls for storage and stability for 5-10 years – is this inconsistent?

A: No, given that BARDA may, as it has in the past, solicit new contracts with companies and we must ensure that adequate samples are taken at initial manufacture and stored appropriately

26. Q: Will currently stored product be maintained on stability in new contract?

A: YES Offerors will receive Task Orders for storage/stability of products currently stored.

BARDA will work with FDA to establish proper guidelines and requirements for long term stored vaccines and adjuvants

27. Q: Since BARDA has varied its manufacturing timeline requirements (manufacture of lots within 12 months vs manufacture of lots within 2-4 months) is there a plan to establish separate

CLINs, one for a slower, standard manufacturing schedule and one for an expedited schedule?

A: There is no plan to create separate CLINs, but companies may propose new CLINs or multi-part CLINs

28. Q: Are all CLINs fixed price?

A: No, there is a mix. See individual CLINs for details.

29. Q: Has there been thought given regarding a CLIN for readiness and sustainment of surge capacity?

A: Yes, but no such CLIN is planned in the current RFP

30. Q: Will stability samples be chosen from lots designated by the company or by BARDA?

A: BARDA requires input into the lots chosen and the number of samples taken to ensure adequate and representative samples are available in the future

31. Q: Will clinical study protocol guidance be dictated in RFP?

A: No

32. Q: Please make clear in RFP what CLINs are fixed price and which will be determined through RTOR

A: OK

BTT Specific Questions

33. Q: Is there a requirement that BTT data submissions be electronic and automatic?

A: No, BTT data submissions can be electronic and automatic or sent manually (via email) as long as they conform to the specified standard.

34. Q: Does the BTT require a full data dump each month or both new and historical data, or just new data?

A: The BTT can accept either a full data dump or only new data, except in the case of stability study reporting (MN014 and MN017) where only new data can be accepted. Manufacturers are also encouraged to submit data as it is generated or updated; at a minimum data will be sent on a monthly basis during normal business and up to three times a day during response activities

35. Q: Will companies be able to verify the data they send to the BTT?

A: Yes, the BTT is set up so that reports specific to each manufacturer will be made available to the manufacturer on a regular basis.

36. Q: Is the cost of initial data streams included in the contract? What about future streams?

A: The cost of the initial standard data submissions (MN001, MN004, MN007, MN014, MN017, and DM002 – see Section F) is included in the contract. The cost of any future data submission requirement will be covered in CLIN0015; an RTOR will be initiated and full details will become available at that time

37. Q: Please clarify what factors are included in the “Loss Factor” calculation which accounts for any product losses from Bulk Drug Product (BDP) to Final Drug Product.

A: Loss factor calculations from Bulk Drug Product through to Final drug Product should be inclusive of: HA over formulation, volume overfill of the primary (vial/syringe) container, BDP formulation losses, filling losses, inspection losses, packaging losses, and all sampling of BDP, formulated, filled and finished products.