Pre-Proposal Meeting Presentation.pdf

September 5, 2012

Acquisition and Advanced Development of a Colony Stimulating Factor (G- or GM-CSF) for mitigation of neutropenia arising from exposure to ionizing radiation

Solicitation Number: RFP-12-100-SOL-00016

Pre-Proposal Conference

Agenda

• Introductions/Welcome

• Overview of Conference

• Overview of RFP

• Responses to Previously Submitted Questions

• Break

• Responses to Questions Submitted at the Pre-

Proposal Conference

• Wrap-Up

Overview of Conference (V. Murthy)

• Review of the Agenda

• The Conference will adhere to this presentation in the interest of potential offerors not present here today

• Note cards will be distributed for any additional questions you may have, we will collect the note cards during the break and respond to the questions; if we are unable to respond today, we will include the questions and responses along with the posting of the documents pertaining to this Pre-Proposal Conference.

• Questions relating to the technical requirements of the RFP will be addressed by Dr. Ron Manning, and business or process related questions will be addressed by me.

Overview of RFP (V. Murthy)

• Solicitation Schedule: August 10, 2012 – RFP issued October 1, 2012 – Intent to Respond due October 10, 2012 – Proposals due by noon

• Proposal Evaluation – in accordance with the Evaluation Factors of the RFP

• Determination of Competitive Range – Notification to Offerors

• Negotiations

─ Questions and Clarifications requested by the CO ─ Possible Pre-award site visits ─ Possible On-site audits to support cost evaluation ─ Discussions/negotiations ─ Final proposal revision

• Source Selection

• Contract Award

Overview of RFP (V. Murthy)

• Questions after conference ─ Submit questions via email to Vijaya L. Murthy at vijaya.murthy@hhs.gov; cc darrick.early@hhs.gov ─ Only written questions will be accepted

• Posting of this presentation and any additional Questions and Answers by September 7, 2012, at www.FBO.gov mailto:vijaya.murthy@hhs.gov mailto:darrick.early@hhs.gov http://www.fbo.gov/

Overview of RFP (R. Manning)

• This Request for Proposals (RFP) is intended to solicit proposals either from companies that are marketing, in the United States, G- or GM-CSF (or PEGylated forms of the same) for the treatment of neutropenia, or to shorten or reduce time to neutrophil recovery; or from distributors with contractual relationships with CSF manufacturing companies.

• This RFP includes the Vendor-Managed Inventory (VMI) requirements under which the Contractor shall maintain and provide availability of the products and quantities 24 hours a day, 7 days a week (24/7).

Overview of RFP (Continued)

• Contract Options (CLIN 0006) are available for the advanced development of an elected cytokine for studies leading to an FDA licensure for the indication of mitigation of neutropenia arising from exposure to ionizing radiation.

• The Contractor shall provide the USG with a compendium of studies which may provide sufficient evidence of efficacy and safety to allow for the USG to place the product under consideration for potential use in a declared emergency under Emergency Use Authorization.

Mandatory Criteria for Eligibility

• The Offeror shall provide a dedicated section in the Technical Proposal that addresses the following mandatory criteria for eligibility:

─ A G- or GM-CSF cytokine product that must have an FDA license for the indication of treatment of neutropenia (shortens time to neutrophil recovery).

─ For Offerors who are the manufacturer, the manufacturing and quality systems for the product shall be established, operationally current, and authorized for continued operation by FDA inspections of the facility(s) within the previous four (4) years.

Evaluation Factors for Award (continued)

Technical Proposal Evaluation

• The Technical Proposal shall address in sufficient detail the Offeror’s understanding of the SOW and propose the following:

─ Qualifications of the Offeror ─ Management Plan ─ Storage facilities

• Technical activities must correspond directly to cost/price in the business proposal. No cost/price information shall be incorporated into the technical proposal.

Evaluation Factors for Award continued

• Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the required evaluation points

• Any proposals submitted for optional Advanced Development, will be evaluated separately.

• The Government will score the proposals based on adjectival ratings which include the following rating categories: Outstanding, Good, Acceptable, Marginal, and Unacceptable.

Responses to Questions

RESPONSES TO QUESTIONS

SUBMITTED PRIOR TO THIS MEETING

BY POTENTIAL OFFERORS

• Q: What is the exact page limit of the Business Proposal, including the Business Proposal Appendices? Please clarify.

• RESPONSE: Please see Section L.3. of the RFP.

There is a page limit of 75 pages only on the Price Proposal to be submitted as a part of the Business Proposal. All other forms and subcontracting plans shall be submitted in their entirety.

Question 1

• Q: Where should the proposal for AR&D work and pricing be included? As a separate document or within the Technical Proposal? Please clarify. Additionally is there a page limit for the AR&D Business Proposal? Please clarify.

• RESPONSE: Please see Section L.2.5. of the RFP. The proposal for Optional Advanced Development CLIN 0006, if submitted, shall be a separate attachment to both the Technical Proposal and Business Proposal and shall be clearly marked as such. The Technical Proposal for CLIN 0006 is limited to 50 pages with another 100 pages for appendices. The Business Proposal shall provide all the pertinent information to support the proposed cost for this CLIN.

Question 2

• Q: The current RFP appears to be a scanned document, since it is not searchable by key words.

Would it be possible to release a searchable version of the RFP to expedite searching the document going forward?

• RESPONSE: A searchable document will be uploaded as an Amendment to this solicitation at www.fbo.gov.

Question 3

• Q: What is BARDA’s expectation with regards to “kitted doses” which was mentioned in the pre-solicitation notice but not in the RFP?

• RESPONSE: There is no mention of “kitted doses” in the Pre-solicitation Notice.

Question 4

• Q: Please clarify what is expected in the “Phase IV post marketing plan/protocol” mentioned in pages 16 and 17? Specifically is BARDA requesting Phase IV clinical studies in accordance with FDA protocol or simply standard pharmacovigilance? How might these post-marketing requirements differ in a pre-approval vs. a post approval setting? Will BARDA follow FDA guidance on these requirements? Please clarify.

• RESPONSE: FDA regulation 21 CFR 601 Subpart H describes the requirements for approval of biological products when human efficacy studies are not ethical or feasible. As approval will be granted based on efficacy demonstrated in animal models, human efficacy must be evaluated after approval is gained. 21 CFR 601.91(b) states that, when feasible, the applicant must conduct post marketing studies during an exigency to verify and describe the product’s clinical benefit. A further assessment of safety must also be conducted during this time. A plan or approach for these studies should be discussed with the FDA and must be included in the Biologics License Application.

As with all licensed biological products, post marketing recordkeeping and safety reporting (pharmacovigilance) must take place for the products that are subject to this RFP.

The applicant should discuss the design of post marketing studies and their pharmacovigilance program with the FDA prior to approval. As the FDA, not BARDA, is responsible for protecting the public health by assuring the safety and efficacy of human drugs, applicants should work closely with the FDA in the design of all their studies.

Question 5

• Q: For CLIN#’s 0001 and 0002, how does BARDA “access” (pages 5 (B.2.c) and 10 (C.3.1 Scope)) differ from CLIN#’s 0003-0005? What specifically is meant by “access”? Please clarify.

• RESPONSE: “Access” refers to this text in Section C.3.1. of the RFP : “The Contractor's plan to provide access to the product as needed by the USG and the Quality Agreement with the CDC/SNS (see Attachment

10) shall be negotiated to align with the USG’s specific product use during a mass casualty event.”

Question 6

• Q: Does the total number of doses to be acquired in CLIN# 0001 equal 2.79 M doses for base period only? If so, then what specifically does CLIN 0002 cover? Is BARDA interested in receiving proposals for 2.79 M doses in base period (CLIN# 0001) and then an additional 2.79 M doses in the option period (CLIN# 0002)? Please clarify.

• RESPONSE: There is no “option period” included in this RFP;

however, there are options to purchase additional supply and services.

The current requirement is up to 2.79M doses, inclusive of CLIN 0001 and CLIN 0002. CLIN 0001 is the minimum requirement of this contract which equals $500,000; CLIN 0002 provides for any additional purchase of product.

Question 7

• Q: Understanding that this solicitation could result in multiple awards, if an Offeror elects to pursue Advanced Research and Development (optional CLIN# 0006); will this impact BARDA’s decision on order size?

• RESPONSE: No.

Question 8

• Q: The RFP includes the Mandatory Criteria: “A G- or GM-CSF cytokine product must have an FDA license for the indication of treatment of neutropenia.” Please advise if HHS would consider revising the mandatory criteria, such that it would be acceptable for the product to have a license for treatment of neutropenia in another country with US licensure anticipated during the course of a contract to result from this RFP. We feel that existing licensures in other countries would also sufficiently support the Vendor Management Inventory requirement of this RFP by allowing the offeror to continually refresh the material stockpiled under a contract resulting from this RFP.

• RESPONSE: Products which have not received FDA licensure for an indication for treatment of neutropenia are not being solicited in this RFP.

Question 9

• Q: The RFP includes the Mandatory Criteria: “For Offerors who are the manufacturer, the manufacturing and quality systems for the product shall be established, operationally current, and authorized for continued operation by FDA inspections of the facility(s) within the previous four (4) years.” If the USG determines that in lieu of FDA licensure, Offerors are permitted to have licensure by another country in order to meet the mandatory criteria, would it possible to revise the facility inspection requirement as follows: “For Offerors who are the manufacturer, in the case of an ex-US licensure only of the product, the manufacturing and quality systems for the product shall be established, operationally current, and authorized for continued operation by the appropriate governmental agency inspections of the facility(s) within the previous four (4) years.”

• RESPONSE: Please see response to Question 9 above.

Question 10

• Q: The RFP currently states “Prior to the submission of the proposal, the Contractor must request regulatory consult with FDA on the appropriate path for approval of their respective therapeutic for use in the treatment of neutropenia arising from exposure to ionizing radiation.” If an Offeror had not already requested and received a regulatory consult with the FDA prior to release of this RFP, it would not seem possible to do so within the 60 day timeline for an RFP response. Subsequently, could this requirement be revised as follows: “Prior to the submission of the proposal and during the proposal process leading up to a potential award, the Contractor is encouraged to request regulatory consult with FDA on the appropriate path for approval of their respective therapeutic for use in the treatment of neutropenia arising from exposure to ionizing radiation.”

• RESPONSE: The RFP states that the Offeror must “request”, not “receive”, consultation with the FDA to discuss the appropriate path for approval of their biological product for treatment of neutropenia arising from exposure to ionizing radiation. This request can be made at any time as long as it is made prior to the submission of the Offeror’s proposal.

Question 11

• Q: Should the RFP mandatory criteria be revised to allow for a G- or GM-CSF cytokine product to have licensure in another country with the goal of US licensure during the course of contract award, it’s also requested that the response date be extended such that there is 60 days from the release of responses to questions until the response date for the

RFP.

• RESPONSE: Please see response to Question 9 above.

Question 12

• Q: RFP section B.1.3 (pg. 4) divides the RFP’s technical requirements into three categories: Product, Services, and Advanced Development. Those requirements are also separated into different Contract Line Item Numbers (“CLINs”). The Advanced Development work is associated strictly with CLIN 0006, which is an optional CLIN according to Section B.

FAR 12.101 states that “Agencies shall—(a) Conduct market research to determine whether commercial items or nondevelopmental items are available that could meet the agency’s requirements; (b) Acquire commercial items or nondevelopmental items when they are available to meet the needs of the agency; and (c) Require prime contractors and subcontractors at all tiers to incorporate, to the maximum extent practicable, commercial items or nondevelopmental items as components of items supplied to the agency.” It appears that all of the Product and Services work, i.e., all work under CLINs 0001 through 0005, qualifies as “commercial item” products or services as defined under FAR 2.101.

FAR 12.301 states that “In accordance with Section 8002 of Public Law 103-355 (41 U.S.C. 264, note), contracts for the acquisition of commercial items shall, to the maximum extent practicable, include only those clauses—(1) Required to implement provisions of law or executive orders applicable to the acquisition of commercial items; (2) Determined to be consistent with customary commercial practice.”

FAR 12.302(c) states “The contracting officer shall not tailor any clause or otherwise include any additional terms or conditions in a solicitation or contract for commercial items in a manner that is inconsistent with customary commercial practice for the item being acquired unless a waiver is approved in accordance with agency procedures.” (Emphasis added.)

The RFP, however, does not indicate that the Products and Services under CLINs 0001 through 0005 are being acquired on a commercial item basis and various aspects of the solicitation appear to be inconsistent with a commercial item acquisition. For instance, many of the FAR clauses that are incorporated by reference are generally not considered applicable in the context of a commercial item acquisition.

Examples include FAR 52.215-2, 52.215-21, 52.216-7, 52.232-20, 52.243-2, 52.249-6, 352.216-70.

Would the Government consider amending the RFP to identify the FAR Clauses that do not apply to commercial CLINs 1 to 5 or allow the Offeror to only respond to the Clauses that the Offeror considers applicable to commercial items. Alternatively, would the Government confirm that the Offeror can take exceptions to the FARs that the Offeror considers not applicable to commercial items?

• RESPONSE: Clauses have been included in the RFP to meet the solicitation requirement for both commercial items and advanced development. Offerors may mark clauses not applicable to their proposal with “N/A” and these will be addressed during negotiations.

Question 13

• Q: RFP section B.3 (pg. 6). Does CLIN 0002 represent acquisition of product quantities in excess of the 2.79M limit specified under CLIN 0001?

• RESPONSE: No.

Question 14

• Q: RFP section C.3.1 1) (pg. 10) ends with an incomplete or missing section “…; and/or”. Please confirm whether or not the RFP is intended to have additional text at the end of this paragraph.

• RESPONSE: The layout is written so that Item 1 “and/or” Item 2 can be understood as 1) a company who has the product and owns the rights to the product “and/or” 2) an Offeror who can serve as a mediator of the VMI (a distributor), could respond to this RFP for consideration.

Question 15

• Q: RFP section C.3.1.2 (pg. 10). This paragraph calls for the provision of an Inventory Management Plan which "shall be provided by the Contractor(s)…" Is this Inventory Management Plan the same plan (“Management Plan”) described in RFP Section L.2.3.2? If this plan is required to be delivered with the proposal, would it be acceptable to include the draft plan as an Appendix to the Technical Proposal?

• RESPONSE: No. The Management Plan is a plan for the entire operation of the contract. The Inventory Management Plan is specific to the management of the product within the context of a vendor managed inventory, or otherwise. The scope of the former does include the scope of the later.

Question 16

• Q: The RFP includes several references to the Project Bioshield Act of 2004. For example, section C.4.1 (pg. 11) states that “At the Government’s sole discretion, the base period may be extended, during performance, pursuant to the additional time parameters set forth in the Project Bioshield Act of 2004.” Section F.1 (pg. 24) states that “Period of performance may be extended pursuant to the Project BioShield Act of 2004.” Please describe the conditions under which the Government may extend the period of performance pursuant to the Project BioShield Act and the resultant requirements upon the Contractor.

• RESPONSE: As stated in the Project BioShield Act, “…the contract shall be renewable for additional periods, none of which shall exceed five years.”

One example is if Advanced Development of an elected cytokine for studies leading to an FDA licensure for the indication of mitigation of neutropenia arising from exposure to ionizing radiation (CLIN# 0006) were to take longer than five years.

Question 17

• Q: RFP section C.5.2.5 (pg. 14); CLIN0006. Please confirm that if we do not bid the optional advanced development task (SOW C.8), there will be no requirement for the Government to conduct inspection and collect samples at our manufacturing facilities.

• RESPONSE: We confirm this.

Question 18

• Q: RFP section C.5.2.7 (pg. 14). The first sentence of this paragraph states "Upon expiration or termination (including partial termination) of this contract…."

Please explain what is meant by "partial termination" and under what conditions would a partial termination be invoked?

• Response: Please refer to FAR Clause 52.249-2, where the government reserves the right to terminate or cancel performance of work under a contract, in whole or in part, if the contracting officer determines that termination is in the government’s interest.

Question 19

• Q: RFP section F.3.2.10 (pg. 29). Deliverables numbered 3 and 4 appear to be missing from the table in section F.3.2.10 (or a mis-numbering of the deliverables exists).

Please provide the information for the missing entries or confirm that the numbering jumps from 2 to 5.

• RESPONSE: The numbering is incorrect; RFP Section F.3.2.10 has skipped numbers 3 and 4; the RFP will be amended to correct this error.

Question 20

• Q: RFP section F.3.2.1 (pg. 30). Item number 8 in the table requires the delivery of Standard Operating Procedures, but does not describe what procedures are to be addressed. In addition, this requirement appears nowhere else in the RFP.

Please identify what procedures are to be described and to what SOW paragraph they apply.

• RESPONSE: Standard Operating Procedures are inferred by the “Quality Systems” described for General VMI Requirements in section C.5 and for the Optional Advanced Development in section C.8. Appropriate procedures include but are not limited to, those used to insure that the product is manufactured in accordance with FDA good manufacturing practice, good clinical practice, good laboratory practice, and all laws and regulations allowing for the licensure and distribution of these products.

Question 21

• Q: RFP section G.4.5 (p. 40) states that “The Government may exercise Options, in accordance with FAR 17.207, to fund the purchase of additional unit doses of the drugs in the quantity designated by the Contracting Officer at the time the Option is exercised during the performance period of the contract at the unit price specified in the contract. Additional inventory management services may also be purchased during the period of performance at the unit price specified in the contract.” What is the purpose of this section? Is this section intended to give the Government the right to exercise options that are not set forth in Sections B or I?

• RESPONSE: This section is intended to give the USG the right to exercise options set forth in the RFP. No, this section is not intended to exercise options that are not set forth in the RFP.

Question 22

• Q: Certain terms and conditions appear to relate strictly to the Advanced Research under CLIN 0006. For instance, RFP section H.2 (pg. 43) relates to acknowledgement of federal funding and states “Contractors funded with Federal dollars, in whole or in part, much acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents. Contractors are required to state (1) the percentage and dollar amounts of the total program or project costs financed with Federal money, and (2) the percentage and dollar amount of the total costs financed by non-Governmental sources.” Sections H.12, H.13, H.14, H.15, H.16, H.17, H.18, H.21 and H.23 (pgs. 47-57) appear to be relevant only to Advanced Research under CLIN 0006. These terms and conditions appear to be inconsistent with customary commercial practice and inapplicable to commercial-item acquisitions. These requirements do not appear to have any relevance to CLINs 0001 through 0005 regardless of whether or not those CLINs are classified as “commercial item” CLINs.

Would the Government consider amending the RFP to identify the Special Contract Requirements of Section H that do not apply to commercial CLINs 0001 to 0005 or allow the Offeror to only respond to the Requirements that the Offeror considers applicable to commercial items. Alternatively, would the Government confirm that the Offeror can take exceptions to the Special Contract Requirements that the Offeror considers not applicable to commercial items?

• RESPONSE: Special Contract Requirements have been included in the RFP to meet the solicitation requirement for both commercial items and advanced development. We confirm that the offeror can take exceptions to the requirements the Offeror considers not applicable to commercial items.

Question 23

• Q: RFP section H.20 (pg. 56) relates to confidential information. It states that “The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract.” Would the Government consider amending the RFP to state that this section is not intended to, and will not, give the Government the right to disclose information that it otherwise would be prohibited or restricted from disclosing under other laws or regulations, including the Trade Secrets Act?

• RESPONSE: The USG is bound to follow the procedures in FAR

3.104 Procurement Integrity which prohibits the disclosure of contractor confidential information.

Question 24

• Q: RFP section I.1 (pg. 58) incorporates several FAR clauses that give the Government the right to extend the quantities or duration of the contract, including FAR 52.217-6, 52.217-7, 52.217-8, and 52.217-9. Each of these clauses includes blanks or placeholders that must be completed. Each includes a placeholder for the period of time in which the Contracting Officer has to exercise the option. FAR 52.217-9 also has a placeholder for the total duration of the contract. Would the Government consider amending the RFP to identify the FAR Clauses that do not apply to commercial CLINs 0001 to 0005 or allow the Offeror to only respond to the Clauses that the Offeror considers applicable to commercial items.

Alternatively, would the Government confirm that the Offeror can take exceptions to the FARs that the Offeror considers not applicable to commercial items?

• RESPONSE: Clauses have been included in the RFP to meet the solicitation requirement for both commercial items and advanced development. Offerors may mark clauses not applicable to their proposal with “N/A” and these will be addressed during negotiations.

Question 25

• Q: FAR 12.214 states that “Cost Accounting Standards (“CAS”) do not apply to contracts and subcontracts for the acquisition of commercial items when these contracts and subcontracts are firm-fixed-price or fixed-price with economic price adjustment (provided that the price adjustment is not based on actual costs incurred).” RFP section K.4 (pg. 72) includes a certification related to the Cost Accounting Standards (“CAS”). The CAS and related FAR clauses are not applicable to commercial-item acquisitions.

Please consider revising the RFP to make clear or confirm that the CAS requirements do not apply to CLINs 0001 through 0005, and only apply, if at all, to CLIN 0006?

• RESPONSE: Requirements have been included in the RFP to meet the solicitation requirement for both commercial items and advanced development. Offerors may mark clauses not applicable to their proposal with “N/A” and these will be addressed during negotiations.

Question 26

• Q: RFP sections L.2.1 and L.2.3 (pgs. 76 and 77). The second to the last paragraph of Section L.2.1 states that "Work should be formatted in separate sections of the Technical Proposal, following the outline of the SOW.” Conflicting instructions are provided in Section L.2.3, which states that the Offeror must show an "understanding of the SOW and propose the following". The following subsections 1, 2 and 3 address "Qualifications of the Offeror", "Management Plan", and "Storage Facilities", which are not consistent with the outline of the subjects in the SOW. Section M.2 provides evaluation criteria consistent with Section L.2.3. Is it acceptable to offer a technical response that responds to each of these areas (the SOW and the three subjects listed in L.2.3) in separate paragraphs provided that the required cross reference index required by L.2.1 is provided?

• RESPONSE: Yes, the intention is for the offeror to address each section of the SOW requested in the solicitation while noting the offeror’s specific qualifications, its management plan and its storage facilities that enable the offeror to effectively complete the SOW.

Question 27

Question 28

• Q: Section L.2.2 of the RFP (“Mandatory Criteria”, pg

77) and L.2.3.1.a (“Product Characteristics”, pg 77) require information about the product that is best substantiated by the inclusion of FDA licensing and prescribing information. However, this information is detailed and lengthy. Is it permissible to include this data as an Appendix to the Technical Proposal to avoid page limits imposed on the Technical Proposal?

• RESPONSE: It is permissible to incorporate the FDA licensing and prescribing information as an Appendix to the Technical Proposal. We would ask that the length of such an Appendix be as concise as possible.

Question 29

• Q: RFP section L.3.3 (pg. 81) includes instructions for the offeror’s Small Business

Subcontracting Plan. Both sections L.3.3 and I.1 (pg. 59) incorporate FAR 52.219-9, Small Business Subcontracting Plan, by reference. Section L.3.3 states that “A Subcontracting Plan must be submitted with the original proposal and will be subject to negotiations if your proposal is determined to be in the competitive range.” FAR 52.219-9(g) states: “A commercial plan is the preferred type of subcontracting plan for contractors furnishing commercial items. The commercial plan shall relate to the offeror’s planned subcontracting generally, for both commercial and Government business, rather than solely to the Government contract. Once the Contractor’s commercial plan has been approved, the Government will not require another subcontracting plan from the same contractor while the plan remains in effect, as long as the product or service being provided by the Contractor continues to meet the definition of a commercial item.” Moreover, FAR 52.219-9(i) states that “A contract may have no more than one plan.” Please confirm that an existing commercial plan compliant with FAR 52.219-9 and currently approved by an agency of the federal government may be proposed to satisfy the RFP’s Small Business Subcontracting Plan requirements, subject to subsequent review and approval by the contracting officer. In addition, is it permissible to include the draft Small Business Subcontracting Plan (as a deliverable) as an Appendix to the Business Proposal?

• RESPONSE: The USG confirms that an existing commercial plan compliant with FAR 52.219-9 and currently approved by an agency of the federal government may be proposed to satisfy the RFP’s Small Business Subcontracting Plan requirements.

Question 30

• Q: RFP section L.3.3 (pg. 83) includes “anticipated minimum subcontracting goals” for this procurement.

The percentages appear high when taking into account the nature of the Government’s requirements and the inherent limitations on subcontracting in the pharmaceutical industry (e.g., FDA requirements that small business sources are often not resourced (either technically or financially) to meet). Will the negotiations between the Government and Offeror include negotiation of the minimum subcontracting goals?

• RESPONSE: Yes, Subcontracting Goals will be a part of any negotiations between the USG and Offeror.

Question 31

• Q: RFP section L.3.4 (pg. 83) requires the contractor to describe the extent of Small Disadvantaged Business (“SDB”) participation expected under the contract. What additional information not requested in the Small Business Subcontracting Plan other should be included in the response?

• Response: None, this shall be addressed in the Small Business Subcontracting Plan.

Question 32

• Q: RFP Attachment 5. Attachment 5 does not indicate the flexibility for annual pricing adjustments under CLIN 0001 and CLIN 0002. Would the Government accept a schedule that reflects a price adjustment over time?

• RESPONSE: Attachment 5 is a Sample Format for Preparing the Price Proposal and may be changed by the Offeror.

Question 33

• Q: RFP section C.4.4 (pg. 12). For what G- or GM-CSF is the Government seeking an emergency use authorization (EUA) and, if any are currently being sought, what is the status of the emergency use authorization(s) and relationship to this RFP?

• Response: RFP section C.4.4 (pg. 12) addresses approved labeling for radiation-induced neutropenia, not which G- or GM-CSF the Government is seeking an EUA for or the status and relationship of this EUA to the RFP.

Question 34

• Q: RFP section B.1.2. (pg. 3) indicates that “A unit dose for the purpose of this solicitation is an adult daily dose and not a multi-dose vial.” Will you please confirm that an adult daily dose for the purpose of this contract will be a mono-dose vial of 480 mcg of filgrastim?

• RESPONSE: For purposes of the costing of this contract an assumption of an adult dose was made whereupon the single dose is assigned as a 300 mcg unit dose syringe. The Government recognizes the need to manage the drug doses for persons where the 300 mcg dose may not be a sufficient daily dose and use of a second dose may be warranted, i.e., one person receives a unit dose and a measured portion of a second dose.

This is a complex event and there will be a lot of patients. We don’t know the dosage requirements up front, so 300 mcg is used for costing purposes to level the playing field.

Question 35

• Q: RFP sections B.3 and D (pgs. 6 and 22). The RFP requires that the Product be packaged consistent with the FDA-approved labeling and packaging for the product at the time of manufacture. Please confirm that Contractor deliveries of Government-owned product will be limited to the United States or its possessions.

• RESPONSE: We can confirm this.

Question 36

• Q: RFP section G.7. (pg. 41). With respect to VMI, please specify on what frequency the invoices are to be submitted.

• RESPONSE: Invoices may be submitted monthly; any deviations to this may be proposed and/or discussed with the contracting officer before award.

Question 37

• Q: RFP sections C (pgs. 9). Please confirm that the Government will assume title to the product upon delivery to the designated VMI facility(s) and assume responsibility for obtaining insurance to cover potential risk of loss or destruction of the Government-owned product.

• RESPONSE: Please refer to FAR Clause 52.245-1 Government Property.

Question 38

• Q: Footnote 1 to RFP section C.3.1(1) (pg. 10) states that “A unit dose for the purpose of this solicitation is an adult daily dose and not a multi-dose vial. A product that requires less than daily dosing, i.e. a PEGylated cytokine, shall be termed an equivalent to seven daily doses.” In the Holmes and Green study of pegfilgrastim in the chemotherapy induced neutropenia indication, patients received 10-14 daily doses of filgrastim compared to 1 dose of pegfilgrastim. How is the Offeror to respond if the proposed PEGylated cytokine is not equivalent to 7 daily doses?

• RESPONSE: For purposes of costing for this RFP, assume a dose of PEGylated cytokine is equivalent to 7 daily doses of the unmodified cytokine.

Question 39

• Q: RFP section C.5.1(f) (pg. 13). Under what scenario(s) would the Government decrease its requirements for the Product? If the Government were to reduce its requirements, would the Offeror be expected to refund some portion of the amounts paid for the Product?

• RESPONSE: The requirement for a cytokine medical countermeasure could possibly change due to a number of considerations including re-assessment of nuclear threat by the Department of Homeland Security and development of alternative treatments (other medical countermeasures). The Offeror would not be expected to refund any portion of the amounts paid for the Product.

Question 40

• Q: RFP section C.5.1(g) (pg. 13). Is it permissible for the Contractor to decline changes to National Drug Codes (NDC)? If not would the Government consider implementation periods to achieve the full required inventory availability level longer than 60 days?

• RESPONSE: The manufacturer and the FDA will negotiate any changes to NDCs and the appropriate product implementation schedule. BARDA would be willing to adjust implementation schedules that concur with those approved by FDA.

• Q: RFP section C.5.1(j) (pg. 13). Please confirm that the notification to the Government of a drug recall is limited to the products delivered to the Government under this contract.

• Response: This RFP states that the CO, COR, and/or other officials as designated by the CO should be notified of a drug recall in writing and within 24 hours.

This requirement not only includes products that are the subject of this RFP, but other drugs which are recalled due to a violation of the law and which may affect the safety, efficacy, and continued supply of the drugs subject to this RFP.

Question 41

• Q: RFP section C.5.2.7(b) (pg. 14). Please confirm that there is no (mandatory) requirement for the Contractor to repurchase any product remaining after expiration or termination of the contract.

• RESPONSE: We confirm this.

Question 42

• Q: RFP section C.6 (CLIN 0004) (pg.15). Please clarify the responsibility of the Contractor for delivery of the product under CLIN 0004 if the designated delivery point becomes inaccessible for any reason outside the control of the contractor (weather, infrastructure access, physical destruction, etc.).

• RESPONSE: The location of a future emergency would not be known in advance though the suitable requirements for delivery to a safe location would be part of the Quality Agreement developed with the CDC and specified on a Notification of Release of Product. If the Offeror proposes the CLIN option for actual delivery, the Contractor shall be responsible for “delivery” to a CDC-specified location.

Question 43

• Q: RFP sections C.7 and E.1 (pgs. 15 and 23). Please confirm that the title to the product will be transferred from the Contractor to the Government upon product acceptance at the VMI facility(s). Please define the Government’s expectations with respect to the acceptance process for Product delivered to the VMI facility(s).

• RESPONSE: The USG will take title of requested product at time of Notification of Release of Product. Product held for the USG shall be treated no differently than other same product accepted into and rotated through the inventory holdings (VMI).

Question 44

• Q: RFP section F.3.2.4 (pg. 26). Please clarify whether the FDA Communications and Submissions will be limited to the product acquired by the Government via Task/Delivery Orders against the IDIQ contract.

• Response: This RFP states that communication between the FDA and the contractor be sent to the Government within a specified time frame for review by the COR and any additional subject matter experts and regulatory staff at ASPR. The COR will also be notified of any audit related to the conformance to FDA regulations and guidance and be provided with copies of the audit report and a plan for addressing areas of noncompliance as identified in the final audit report. These communications and submissions are necessary to insure the safety and effectiveness of products that are subject to this RFP and their continued supply. Therefore, the requirements in this section also apply to products that are not subject to this RFP yet their noncompliance with FDA laws and regulations may affect the safety, efficacy, and continued supply of products subject to this RFP.

Question 45

• Q: RFP section C.5.2.5 (pg. 14). Under what conditions or events does the Government anticipate inspecting the VMI facility(s) or taking samples? How many samples of Product does the Government anticipate taking during an inspection and how often does the Government expect to conduct inspections? May we assume that the Government will pay for the replacement of all Product removed from the inventory as part of its inspections?

• RESPONSE: Please refer to Section C.5.1. c. of the RFP.

Inspection and Acceptance will be in accordance with Section E of the RFP and FAR Clause 52.246-2

Question 46

• Q: RFP section H.9 (pg. 46) relates to liability protection. It states that “The Secretary’s Declaration for Public Readiness and Emergency Preparedness Act (PREP Act), Section 319F-3 of the Public Health Service Act, 42 U.S.C. 247d-6d, applies to this contract, subject to the terms and conditions of such Declaration and any amendments thereto.” Please confirm that the Secretary has, or will have at the time of the contract initiation, issued a PREP Act declaration to cover the delivery of product under this procurement.

• Response: This countermeasure is already covered under the PREP Act.

Please refer to the following websites for information relating to the PREP Act:

For ARS http://www.gpo.gov/fdsys/pkg/FR-2008-10-17/html/E8-24735.htm

Existing PREP Act Declarations can be found at http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

Question 47 http://www.gpo.gov/fdsys/pkg/FR-2008-10-17/html/E8-24735.htm http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

• Q: RFP section H.9 (pg. 46) relates to liability protection. It states that “In the event the Contractor delivers product under this contract which is not covered by the aforementioned declaration because of the expiration of the aforementioned declaration and any renewals or amendments thereof, the Government agrees that the medical countermeasure delivered by the Contractor under this contract will not be administered for use in humans, unless the Secretary executes a new declaration in accordance with section 319F-3(b) of the Public Health Service Act, 42 U.S.C. 247d-6d, or renews or amends the existing declaration, to provide that such medical countermeasures delivered under this contract are covered countermeasures to which section 319F-3(a) applies subject to the terms and conditions of the Declaration and any amendments thereto, and the new or renewed or amended declaration provided the Contractor at least the same coverage as the aforementioned declaration.” This appears to be a commitment that the Government will only use product if a PREP Act declaration is in place. This is potentially problematic for the contractor because, although Government use without a PREP Act declaration could constitute a breach of contract, it would not necessarily protect the contractor from the threat of substantial third-party liability. In light of the foregoing, would the Government be willing to revise RFP section H.9 and the corresponding technical requirements to make clear that the contractor is not obligated to deliver product to the Government if a PREP Act declaration is not in place? Alternatively, would the Government confirm that the Contractor is not obligated to deliver any product to the Government if a PREP Act declaration is not in place or effective at the time the Notification of Release of Product is placed?

• Response: This countermeasure is already covered under the PREP Act.

Please refer to the following websites for information relating to the PREP Act:

For ARS http://www.gpo.gov/fdsys/pkg/FR-2008-10-17/html/E8-24735.htm

Existing PREP Act Declarations can be found at http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

Question 48 http://www.gpo.gov/fdsys/pkg/FR-2008-10-17/html/E8-24735.htm http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx

• Q: RFP section K (pg. 69) includes several FAR clauses with representations and certifications that do not apply to commercial item acquisitions. For example, FAR 52.204-8, Representations and Certifications, does not apply to commercial item procurements in accordance with the prescribing language FAR 4.1202. Would the Government consider revising Section K to remove clauses that do not apply to commercial items or make clear that an offeror proposing only CLINs 0001 through 0005 is only required to provide the FAR 52.212-3 representations?

• RESPONSE: Requirements have been included in the RFP to meet the solicitation requirement for both commercial items and advanced development. Offerors may mark requirements not applicable to their proposal with “N/A” and these will be addressed during negotiations.

Question 49

• Q: RFP sections L.3.6 (pg 85) and M.2.5 (pg 98) require that the Offeror submit past performance information with their proposal. In particular L.3.6 requires that at least three (3) Past Performance Questionnaires (included as attachment 11 to the RFP) be submitted.

Normally past performance questionnaires made part of Federal procurements are sent by the Offeror to the program representative (program manager or contract officer) of the Offeror’s candidate programs. After completion the questionnaires are then returned directly to the procuring contract officer listed in the RFP. However, the BARDA RFP contains no such instructions.

Should we assume that the questionnaires be sent directly from the candidate past performance programs to Vijaya Murthy at the address shown in RFP Section L.1 (pg 75)? If so, should we also assume that the due date for the returned questionnaires is no later than the due date for the rest of the proposal?

• RESPONSE: Yes, as instructed by the RFP in Section L.3.6., past performance questionnaires are to be submitted directly to Vijaya Murthy by the offeror no later than the due date for the rest of the proposal.

Question 50

Responses to Questions

RESPONSES TO QUESTIONS

SUBMITTED AT THE MEETING

BY ATTENDEES

Question 1

• Q: On Page 5 of today’s presentation, it states in part “from companies that are marketing in the US…” On Page 7 of the presentation it states “have an FDA license”

A G-CSF product recently received FDA approval but due to legal action does not have marketing approval until November 2012. Would this product be eligible to bid?

• RESPONSE: See Section M.2.1. a.

Question 2

• Q: Please confirm that the contractor does not need to request a consultation with FDA if it does not intend to respond to CLIN 0006

• RESPONSE: We confirm this

Question 3

• Q: The contractor will manage the inventory on behalf of the USG as soon as the product becomes physically available at the VMI facility. Would the USG take ownership (via title transfer) at the time of product acceptance?

• RESPONSE: USG takes title and possession when the Notification of Release of Product is implemented. However, the contractor may invoice for the product when it is delivered into the VMI.

As a product rotates through a warehouse, the government “owns” a certain amount, but exactly which vials constantly rotate. That’s why the government can’t take ownership upon delivery to VMI. Repurchasing is not sustainable over time, that’s why we’re looking to create a supply chain bubble.

Additional Question 1

• Q: Will you please clarify whether the contractor will need to supply 300 mcg unit dose pre-filled syringes or will be able to deliver a vial presentation instead? Alternatively, would the contractor be able to offer a mix of presentations including pre-filled syringes and vials?

• RESPONSE: According to the RFP, section C.4.2 (page 11), “The finished drug product (FDP) shall be packaged in single unit dose syringes or vials or other approved packaging, and potentially as full treatment course packaging, to provide for the most cost-effective product life-cycle value and performance, and to allow for ease of distribution and use during a declared emergency.” Thus, the offeror may propose pre-filled syringes, vials, or a mix of the two.

Additional Question 2

• Q: Will you please verify Response to Question 33? The response is [RFP section C.4.4 (pg. 12) addresses approved labeling for radiation-induced neutropenia, not which G- or GM- CSF the Government is seeking an EUA for or the status and relationship of this EUA to this RFP]. Should the response say “addresses approved labeling for treatment of neutropenia in symptomatic adults […] and children”?

• RESPONSE: Yes, the response should say, “addresses approved labeling for treatment of neutropenia (shorten or reduce time to neutrophil recovery) in symptomatic adults […] and children”

Additional Question 3

• Q: Related to Question 33, will the Government issue task/delivery orders to purchase G- or GM-CSF for FDA approved label indications and in parallel or subsequently obtain an EUA for radiation-induced neutropenia for the acquired G- or GM-CSF? Or will the Government issue task/delivery orders to purchase G-or GM-CSF for FDA approved label indications only when an EUA for radiation-induced neutropenia is in place? Will the Contractor be notified of the effective date of the EUA?

• RESPONSE: Task orders will only be issued for products which have received a determination issued to the CDC by the FDA that sufficient information has been provided by the CDC to conclude that in the event of a declaration under section 564(b) of the Federal Food, Drug, and Cosmetic Act (the Act) involving a nuclear/radiological threat agent, it is reasonable to believe that the product may be effective in increasing survival by decreasing the risk for serious infections in humans exposed to myelosuppressive radiation following a radiological/nuclear incident. A radiological/nuclear incident that causes myelosuppression is a life-threatening event.

Wrap Up

Closing Remarks Any additional questions or clarifications provided to attendees will be included in the presentation before posting

Thank you for attending the Pre-Proposal Conference.