Q A_-_1.pdf

Questions & Responses 5.5.16

The following questions were received from potential offerors related RFP 16-100-SOL-00011. These questions and answers are hereby incorporated into the solicitation. These responses supersede any conflicting information issued in the original RFP.

Question BARDA Response

Will BARDA provide a forecast for Task

Order Requests (TOR)? Which product(s) funded by BARDA are currently under consideration for TORs?

Each Task Order Request is considered an individual request, and lead times for response, and completion vary depending on the task. BARDA will attempt to provide advanced notification of upcoming task orders, when possible. This advance notification does not reflect an intention to commit to a new task order being initiated.

What is the significance of the addition of

"Respiratory Illness“ to the heading of the

RFP from the draft RFP when the other material aspects have not changed from the draft?

This is name change and does not impact the overall expectations of the Request for

Proposal

What is the expected typical time line from issuance of the TOR – task order signature

– provision of Drug Substance – release of

Drug Product?

Each Task Order Request is considered an individual request, and lead times for response, and completion vary depending on the task.

Upon validation of a process after Task

Order award, is it expected to perform process specific aseptic revalidation every 6

Each Task Order Request is considered an individual request, and the scope of work for each task order can and will be specific month? to the TOR, therefore some TORs may require continued aseptic qualification, and others not.

Is the disclosure of "Past Performance“ reference performance as a prime contractor, as subcontractor or both (pg.

48)? Please note within the Sample Task

Order Requests (STOR), there is inconsistency in seeking disclosure of "5 contracts during past 3 years“ (STOR1 pg.

9) and "3 contracts during the past 5 years“

(STOR2 pg. 8)

"Past Performance" can reference performance as both a prime contractor and/or a subcontractor. Responses to

Sample Task Order Requests (STORs) should disclose the relevant contracts/orders as specified in the individual STOR. I.e. five (5) for STOR1 and three (3) for STOR2.

Will a Small Business Subcontracting Plan need to be generated in response to each

STOR or for the base contract as a whole?

If applicable to the base contract as a whole, what scope of work and estimated annual value should offerors use for purposes of developing a Small Business

Subcontracting Plan?

The Small Business Subcontracting Plan would need to be generated for the base contract as a whole. Offeror's should estimate Task Order's (TOs) similar in scope and value as Sample Task Order

Request Nos. 1 and 2. Total value of estimated TO awards should not exceed

$100M. Note: small businesses are exempt from completing a small business plan.

Will the response to STORs need to be in the cost/price format indictated for each

Offerors may propose their own cost/price formats for each CLIN structures in

CLIN (Cost Plus Fixed Fee and Firm Fixed

Price) or is this provided merely by way of example?

response to the STORs.

Attachment No. 10 references a due date of

May 6, 2016. What does this date refer to and what is required by that date?

This date represents the date to submit the

Past Performance Questionare (attachment

10) to the individual identified on the attachment. Date will be revised to the

Proposal Due Date (currently May 27, 2016).

The Solicitation contains FAR 52.222-43, Fair Labor Standards Act and Service

Contract Act - Price Adjustment (Multiple

Year and Option Contracts). However, the

Solicitation does not contain FAR 52.222-

41, Service Contract Labor Standards.

Please confirm that the Service Contract

Labor Standards do not apply to this

Solicitation.

This was an oversight. FAR 52.222-41

Service Contract Labor Standards (May

2014) is hereby included in this solicitation.

The Solicitation contains HHSAR 352.224-

70, Privacy Act, but the Solicitation does not require offerors to design, develop, or operate a Federal agency system of records to accomplish an agency function. Please advise why this clause is in the Solicitation and to which records it applies.

Any product data etc. developed by the contractors or provided by the USG, will be subject to the Privacy Act and will be considered sensitive information. This information may vary depending on individual task/delivery orders.

Contractors will be required to provide executed Master Services and Quality

Agreements and also Non-Disclosure/

Confidentiality Agreements which shall address any Privacy Act and sensitive information concerns.

In Section L.2.1 (p. 44), the first paragraph includes a requirement for an index, which does not count towards the Technical

Proposal page limitation. Does the index count towards the Appendix 150 page limitation?

The "Index" does not count toward the

Appendix 150 page limitation.

Section L.2.1 (p. 44) provides that the

Technical Proposal may not exceed 100 pages and the appendix may not exceed 150 pages. Please confirm that these page limits are not inclusive of one another, and

Page limits of the technical Proposal and the Technical Appendices are not inclusive or each other. The technical Proposal plus the appendix can be up to 250 pages long

(100 Tech proposal; 150 appendix).

therefore the Technical Proposal plus the appendix can be up to 250 pages long.

Is the Technical Proposal title page

(Section L.2.1.1, p. 44) included in the 100 page Technical Proposal page limit?

The Technical Proposal title page is not included in the 100 page Technical

Proposal page limit.

Section L.2.1 states that the technical proposal responses to STOR shall be included in the appendix, not in the technical proposal (p.44). However, the technical proposal responses for the STOR are included in the sample Table of

Contents for the Technical Proposal (p.45).

Please confirm that the technical proposals to the STOR should be included in the technical proposal appendix, and whether it will be subject to the appendix 150 page limitation.

Responses to the STORs shall be included in the Technical Proposal Appendix and are subject to the 150 page limit.

Section L.2.1.1 states that the business portion of the STORs shall be limited to 15 pages (p. 45). However, Section L.3.2 states that the STOR business proposals shall not exceed 20 pages each and Section

9.5 of the STOR provides that there is no page limitation for the Volume II – Price

Submission. Please confirm whether the business proposals for the STOR are subject to the 15 page or 20 page limits, or no page limit.

Business portions for the STORs shall be limited to 20 pages each as identified in

Section L.3.2. Section L.2.1.1 is hereby revised to reflect this change.

The STOR in Section L.2.1.1 (p. 45) requires the submission of a Gantt chart.

Do the Gantt charts count towards the appendix 150 page limit? To be readable, often Gantt charts are larger than 8 ½” x

11”. If provided in electronic form, how will the Gantt charts be counted towards the page limits?

Gantt charts will count toward the 150 page limit. However, submission of the Gantt charts can be on a larger page, up to 11" by

17".

The technical responses STOR are referenced in both Section 4: Statement of

Work and Section 5: Technical Proposal

Expectations of the sample Table of

The technical responses to the STOR should be included in Section 4: Statement of Work. Section 5 is the Technical

Proposal overall technical capabilities of

Contents (pp. 45-46). In which Section should offerors include the proposals to the

STORs?

the offeror to provide Fill / Finish Services to the USG, whereas the STOR technical approach information are specific to the

Task Orders themselves.

The sample Table of Contents, Section 5

(B) (p. 46), includes a requirement to provide resumes in an appendix. Do these resumes count towards the 150 page limit for the appendix?

Resumes will count towards the 150 page limit for the appendix.

The evaluation criteria in the STORs include a requirement to submit past performance information. Section L.3.2 also includes a requirement to submit past performance information (p. 48). Should offerors submit one set of past performance information in response to the RPF, or different sets for the response to the RFP and each STOR?

Past Performance information should be submitted for both the response to the RFP and also the responses to the STORs. It is understood that this Past Performance information may be the same for the different responses.

Is there a page limitation for the Appendix to the Business Proposal?

Appendices to the Business Proposal are only applicable where called out. There is no page limit to the Business Proposal

Appendix.

Section L.3.4(4) (p. 50) references a 50 page limit for the Business Proposal but

Section L.3.2 references a 75 page limit for the Business Proposal (p. 47). Please confirm which page limit applies to the

Business Proposal.

Business Proposal shall be limited to 75 pages each as identified in Section L.3.2.

Section L.3.4 is hereby revised to reflect this change.

Section M.1.3, Technical Evaluation

Criteria (p. 55) provides the relative importance of technical subfactors (i)

Technical Approach and (ii) Quality

Assurance/Quality Control Plan, but not

(iii) Experience of Key Personnel. What is the relative importance of subfactor (iii)

Experience of Key Personnel as compared to the other subfactors?

When combined the Technical Approach and Quality Assurance/Quality Control

Plan are more important than level of experience and price.

How will Business Proposal evaluations be conducted as between the base contract business proposal and the STOR business proposals? Is there a mathematical formula

BARDA intends to employ for developing an overall evaluated cost/price?

Each section of the Business Proposals, i.e.

the STORs, shall be evaluated separately.

The USG will look at the Best Value overall, when all factors (including technical) are combined.

Is there a preferred format for the submission of the Business Proposal for the

There is no preferred format for the

Business Proposal base contract?

What are the different documentation requirements and auditing procedures for fixed price vs cost plus, if any?

Offerors should seek professional consultation to fully understand the distinction between the regulations/oblgitations fixed price vs.

cost-type contracts. In general, cost-type contracts require more information to determine reasonableness and realism for each cost component, whereas fixed-price contracts only require enough information to determine price reasonableness.

Is it acceptable to use our internal exchange rate policy of Euros to Dollars or is there a preferred exchange rate recommended?

There is no preferred exchange rate calculation.

What is the expected container size, fill volume?

Per CLIN0001AA, the USG is not providing a specific vaccine partner for the purposes of the Task Order. As this is only a Sample Task Order, the offeror should evaluate Influenza product/ information which is available in public domain to determine the appropriate information to provide a response to the STOR.

What is the expected overall number of containers to be filled?

Per CLIN0001AA, the USG is not providing a specific vaccine partner for the purposes of the Task Order. As this is only a Sample Task Order, the offeror should evaluate Influenza product/ information which is available in public domain to determine the appropriate information to provide a response to the STOR.

What is the expected batch size? Per CLIN0001AA, the USG is not providing a specific vaccine partner for the purposes of the Task Order. As this is only a Sample Task Order, the offeror should evaluate Influenza product/ information which is available in public domain to determine the appropriate information to provide a response to the STOR.

What is the expected campaign, that is, the number of batches prior to isolator sterilization?

Per CLIN0001AA, the USG is not providing a specific vaccine partner for the purposes of the Task Order. As this is only a Sample Task Order, the offeror should evaluate Influenza product/ information which is available in public domain to

What is the expectation of emergency vaccine supply readiness for Pandemic

Influenza Virus Vaccine with respect to process development and warm base fill and finish services (eg. continuous process training and verification every 6 months) and is a schedule for such services required in response to this STOR?

The offeror should include the activities and frequency anticipated for maintaining a warm-base state for rapid response to a

USG request for pandemic influenza product.

Please note typographical error in Section

4.0 (pg. 5) referencing both an "eighteen“ and "(36)“ month period of performance?

Which is correct?

The correct Period of Performance is 36 months. The RFP will be revised to reflect this change.

Page 16 of the RFP specifies adherence to the Clinical Laboratory Improvement Act

(CLIA), which does not appear to be applicable to the statement of work. Please clarify.

The requirement to adhere to the Clinical

Laboratory Improvement Act should not apply to this Request for Proposal and the

RFP will be revised to reflect this change.

Under Section L.3.4 Other Administrative

Data, item (2) requests a list of current

Government commitments relating to the work contemplated and ANY proposal submitted for any Government solicitation.

Is the request for outstanding work also limited to work relating to the provided scope?

This request is not limited to only work relating to the provided scope.

Will bulk drug substance for each of the three lots be provided in a single shipment and require filling within the same timeframe, or are multiple shipments over time anticipated?

Drug substance lots would be anticipated to be received over time.

Will the TRIS buffer formulation be provided? If TRIS buffer is manufactured by contractor, are release and stability testing required? If yes, specify the test methods.

TRIS buffer can either be provided by the original Intellectual Property Owner, or manufactured by the contractor on site.

In process testing is specified in section 2.3

C. Will bulk drug substance or final product release and stability testing be performed by contractor? If yes, please specify methods and indicate whether

1) Bulk drug substance should be received from the Intellectual Property Owner in a released state.2) Release and Stability

Testing should be performed by the

Intellectual Property Owner.

methods are developed and ready for transfer.

Will the concentration of the drug substance after formulation need to be confirmed prior to fill? If yes, please specify the method and allowable drug substance hold time.

1) Due to the temperature sensitive nature of the product, concentration testing of the formulated drug product prior to filling is not required.

2) The drug product has been determined to be highly sensitive to temperature;

therefore, the product requires minimal processing time outside of frozen conditions. In order to minimize exposure to room temperature, the filling processing time is required to be managed to be completed within 8 hours from initiation of the filling process.

Other than for sterility and endotoxin, is method qualification required?

As this is early phase clinical testing of an unlicensed product, full technical transfer of the process is not required, however, limited validation, written procedures and cGMP must be in effect for the manufacture of each batch of this investigational drug product lot. The requirements for the manufacturing of the lot(s) should be maintained within the outlines of the Food and Drug

Administrations’ (FDA) “Guideline on the

Preparation of Investigational New Drug

Products (Human and Animal)”, dated

March 1991.

Section 2.2 states that the IP owner is responsible for final product release;

Section 2.3 (D) states contractor is responsible for product release. Please clarify.

The original intellectual property owner is responsible for final product release and ensuring a safe operating environment.

The RFP will be revised to reflect this change.

The labeling and inspection of the 7000-

10,000 vials will need to be performed over a series of days. What is maximum allowable storage time of vials, between fill and inspection, at 2-8°C?

The drug product has been determined to be highly sensitive to temperature;

therefore, the product requires minimal processing time outside of frozen conditions. In order to minimize exposure to room temperature, the filling processing time is required to be managed to be completed within 8 hours from initiation of the filling process. Once filling is completed, the filled/stoppered and sealed vials require processing in a controlled rate freezer. Once frozen, the final drug product is to be stored at < –60C.

Is an AQL inspection required for filled/inspected vials?

As this is early phase clinical testing of an unlicensed product, full technical transfer of the process is not required, however, limited validation, written procedures and cGMP must be in effect for the manufacture of each batch of this investigational drug product lot. The requirements for the manufacturing of the lot(s) should be maintained within the outlines of the Food and Drug

Administrations’ (FDA) “Guideline on the

Preparation of Investigational New Drug

Products (Human and Animal)”, dated

March 1991.

Is packaging of final labeled vials using standard cryovials boxes acceptable? If not, As there are no packaging requirements outlined in the Task Order, the offeror please specify required clinical package requirements.

should propose they're recommended presentation.

Initiation of the period of performance provided in the task order has expired. For the purposes of scheduling and costing, please provide an anticipated start date for the task order.

The process transfer is anticipated to be completed prior to the end of the 4th quarter 2016. The formulation, fill and finish activities are anticipated to occur between the end of 4th quarter 2016 and the 1st quarter 2017. The RFP will be revised to reflect this change.

Please indicate whether methods are developed and ready for transfer to the contractor?

The Contractor shall identify, qualify and establish a manufacturing contract with a current approved manufacturer / supplier of pandemic influenza vaccine to secure formulated drug substance for formulation, filling and packaging.

What is the estimated number of doses to be filled per lot?

Per CLIN0001AA, the USG is not providing a specific vaccine partner for the purposes of the Task Order. As this is only a Sample Task Order, the offeror should evaluate Influenza product/ information which is available in public domain to

Section 4.0 Period of Performance states both "eighteen" and "36" month periods.

Please clarify.

The correct Period of Performance is 36 months. The RFP is hereby revised to reflect this change.