EBOLA_Vaccine_Q&A__1.pdf

RFP 17-100-SOL-00013 Questions and Answers

EBOLA Vaccine

17-100-SOL-00013

QUESTIONS AND ANSWERS

The following are answers to questions received from potential Offerors:

Q1: Should Options 4-6, 7-9, 10-12, and 13-15 be priced assuming that

(a) options are exercised sequentially, such that they each reflect the cost of 240,000 doses, or

(b) all prior options are also exercised such that option 4-6 represents a single purchase of 240,000 additional doses and option 13-15 represents a fourth purchase of Option doses for a total purchase of 1.07M doses?

A1: These options should be priced on a cost per regimen basis. The exercising of these options will be based on government needs and availability of funding. However, the general strategy is to exercise the options over the course of the contract to achieve a total of 1.13M regimens (including the 60,000 in the Base Period with CLIN 2).

Q2: Will the Government identify potential locations for Strategic National Stockpile deliveries or provide assumed locations to allow contractors to accurately price deliveries?

A2: The Government will not identify locations at this time. The proposal shall assume shipments to be split among multiple locations in the United States.

Q3: Can the Government elaborate on the split between labeled vials available for immediate use and bulk to be held in inventory? Are there expectations for how this split might differ for the different options in the contract (i.e., is there a desire to hold earlier option volumes in vials and later in bulk or is there a consistent vial/bulk split for each option)?

A3: The 60,000 regimens delivered in the Base Period must be in Final Drug Product form. The

Offerors shall propose a mix of Final Drug Product and Bulk Drug Substance for the options per the instructions in the solicitation. The Government goals are to maximize the overall shelf life of material while minimizing costs.

Q4: Can the Government provide additional guidance on the anticipated time from receipt of the

Government’s exercise of an option to expected delivery of ordered material?

A4: The assumption is that this will be based on availability of facilities and time needed for manufacturing. The Government does not have any firm requirements.

Q5: Can the Government confirm that FAR 52.227-14, Alternate II, should be included in the solicitation and that a contractor will be permitted to mark as limited rights data all qualifying proprietary information submitted to the Government?

A5: If applicable and conducted, this will be discussed at the time of negotiations and contract award.

Q6: Can the Government to confirm that FAR 52.227-3 should not be identified in the solicitation because a patent indemnity is inappropriate when a contract involves non-commercial items?

A6: If applicable and conducted, this will be discussed at the time of negotiations and contract award.

Q7: Will the Government replace FAR 52.203-98 (Deviation 2015-02) with the new corresponding provision FAR 52.203-18?

A7: Yes, this provision has been updated.

Q8: Will the Government remove FAR 52.227-3 based on the non-commercial nature of the work at issue and potential for a patent indemnity to impact price?

A8: If applicable and conducted, this will be discussed at the time of negotiations and contract award.

Q9: The current TPP focusses on long term storage at frozen conditions. Shorter storage at 2-8°C is also possible, but is unlikely to reach the required 5 years. Would BARDA desire to proceed with 2-8°C stable product even if that would require additional costs for (development of) a lyophilized or liquid product?

A9: Any late-stage development (CLIN 0001) shall focus only on critical development path items to achieve licensure. Development of a lyophilized formulation (or other formulation improvements) is not appropriate for this solicitation, unless it is on the critical path to licensure.

Q10: In CLIN 0004 to CLIN 0015, potential additional purchase of vaccine regimens is discussed and it is indicated that the efforts include manufacturing, stability testing, and storage. The Offeror is requested to propose price per dose for both VMI and SNS. It is mentioned that storage at the intended storage temperature of up to 5 years is supported; however there is no explicit indication as to the amount of time the product should be stored for. Should the Offeror provide a quote for storage and maintenance of the VMI per year of storage or for the full period of 5 years?

A10: The price per regimen should factor in all costs associated with storage and maintenance.

It is assumed that the total amount of storage time would be based on the expected expiration date. The storage and maintenance costs shall cover that entire period.

Q11: For CLIN 0004 to CLIN 0015, potential additional purchase of vaccine regimens is discussed. It is assumed that the product produced as part of the process validation campaign (so-called PPQ runs) would be acceptable for this purpose. Does BARDA agree with that approach?

A11: CLINs 0004-0015 will be exercised based on government needs and availability of funds.

Therefore, it is not guaranteed the production of such material will align with dates for these CLINs. Please propose the costs as if new lots would be manufactured to support those CLINs.

Q12: If a manufacturer has additional supplies available from an earlier campaign using the same process as later validated, which could be delivered more rapidly, albeit with a shorter remaining shelf life, and which could serve as a bridge between the current situation of limited emergency supplies to a situation where the stockpile is supplied with a validated process. Would BARDA be interested in receiving an option under the RFP to this effect? The product could be delivered either as SNS or kept as VMI.

A12: Please propose the costs as if new lots would be manufactured to support all procurement

CLINs.

Q13: Should the Offeror include an early access strategy in the proposal (e.g. to allow health care workers having to work in Ebola affected areas access to vaccine prior to full licensure)?

A13: The Offeror may include such information for reference. However, it should only be included as part of the SOW and cost proposal if the Offeror feels it is part of the critical path to licensure.

Q14: The Offeror is required to include within the Business Proposal Attachment 6, entitled "Protection of Human Subjects". The content of this form found on pages 78/79 does not appear to pertain to this topic. This table appears to be a mix of a number of different requirements many that are included/captured within other proposal sections and includes limited reference to “Protection of Human Subjects.” Is the content on pages 78/79 correct or is there a different document on "Protection of Human Subjects"?

A14: This is a template for future purposes. Please note all Offerors must have an FWA assurance number.

Q15: The Offeror is contemplating three studies as part of a post ‘authorization’ commitment. Given the high degree of uncertainty surrounding the exact nature of any Post Marketing Commitments (PMC) in the future, developing a singular budget around these studies is also very imprecise.

Therefore, would it be acceptable to present a budget range for the PMC studies with high level assumptions to support the budget numbers in the proposal or do you require a single budget number?

A15: Please submit a single budget for the PMC CLIN.

Q16: Solicitation Section L.4. Technical Proposal, subsection L.4.1.1 Technical Proposal Components, Section 2 Technical Proposal Overview and Section 3 Technical Criteria describe the content and descriptive information required to be included within the Offeror’s proposal while considering the Technical Evaluation Criteria identified in Solicitation Section M. Also indicated within L.4.1.1, Section 3 is a reference to the SOW to be submitted as a separate part of the technical proposal (which will be incorporated into the contract award). Please confirm that a Statement of Work document, separate from the Technical proposal will be accepted and considered for any eventual contract award.

A16: The Statement of Work shall be part of the Technical proposal and will count toward the

100-page limit.

Q17: Section B.4. “Provisions to Applicable Costs”, identifies a list of “unallowable costs”, please clarify the following:

a. “Travel Costs including foreign travel” are unallowable unless approved by the Contracting Officer. There are other references within the solicitation that indicate travel is an allowable cost. Please clarify if travel will be allowable and what if any additional restrictions may be placed on the approval of such costs.

b. Consulting Agreements – reference is made to “cost-reimbursement type subcontracting (including consulting agreements)”. Please clarify that the unallowable nature of subcontractors (including consulting agreements) is only for the cost-reimbursement subcontracts and not all consulting agreements.

A17: a. Travel costs are allowed to be proposed as reimbursable costs. However if a contract is awarded, for any foreign travel, prior approval must be obtained from the Contracting Officer.

b. Consulting agreements are allowed to be proposed as reimbursable costs (either as cost-reimbursable or fixed-price agreements). For any such agreements under a potential contract, prior approval must be obtained from the Contracting Officer.

Q18: HHS Section 508 Product Assessment (attachment 7): This form appears to relate to website content and electronic and information supplies and does not appear to be applicable to the scope of this agreement. Please confirm this requirement does not apply to this solicitation or how and in what manner this requirement would apply.

A18: This is a requirement of the solicitation; please fill out the template found from the link in the solicitation.