Second Q AsRFP 11100SOL00020.pdf

Questions and Answers

RFP No. 11-100-SOL-00020

No. Question Response Solicitation Revision

Question 86: HHS Response: Contractors will receive the materials needed to produce optizimized master and working seed lots that can be handled in BSL2+ facilities. Generation of reassortants is not required. BARDA will facilitate cooridination between industry and federal agencies.

FOLLOW-UP QUESTION: If an Offeror's licensed influenza manufacturing process includes generation of reassortants with a proprietary donor strain backbone how does BARDA plan to provide a BSL2+ reassortant?

If an Offeror's licensed influenza manufacturing process includes the generation of reassortants then there will be no need for BARDA to provide reassortant candidate vaccine viruses.

No

Question 19: HHS Response: Contractors shall provide documentation to HHS to support a pre-EUA document preparation. This information will include i.e. summaries of safety and efficiacy data and investigator's brochure.

FOLLOW-UP QUESTION: For the response to question 19, it is still unclear what should be submitted to support a pre- EUA package. For example, a) is the pre-EUA package intended to support use of a novel pandemic strain, a novel delivery presentation, or something else? b) Since clinical data will not yet be available 1 year after award, is it acceptable to report the pandemic type LAIV preclinical data, an provide an IB summarizing this data satisfy the requirement for providing information to HHS for preparation of a pre-EUA document?

A) The pre-EUA will support the use of pandemic vaccine. B ) Yes. However the contractor must provide relevant data when they became available.

No

Please provide: 1) the scope of required activities for international shipment and 2) specific destinations for international shipments (eg., airports vs clinic, consignee).

The information provided is not sufficiently clear for accurate pricing.

1) CLIN 0014B will be required for international donation only. 2) airport No

Solicitation 11-100-SOL-00020

Questions and Responses Number 2 Acquisition of MCMs for Pandemic Influenza Preparedness and Response

RFP No. 11-100-SOL-00020

No. Question Response Solicitation Revision

Solicitation 11-100-SOL-00020

Questions and Responses Number 2 Acquisition of MCMs for Pandemic Influenza Preparedness and Response

In section L.4 on page 42, the RFP says, “…shall submit a detailed technical proposal and presentation…” What is meant by “presentation”? Is this a PowerPoint presentation detailing the technical and business proposals? If so, is there a page limit to such a presentation? Would the presentation pages be excluded from the proposal page limit? Is BARDA considering holding face to face oral presentations?

The word "presentation" has been removed from the section. Yes

Should an Offeror assume that CLINs 0004 and for instance 0012 are to be linked if an order is placed when a pandemic is imminent, and consequently provide a work plan for end to end manufacturing with a quotation of what could be delivered on what timeline? This could imply different pricing for providing “pre-pandemic” vaccine versus “pandemic” vaccine; would such an offer be acceptable?

No, please provide pricing based on the information listed in the RFP. No

If an Offeror has two US-licensed influenza vaccine facilities, would HHS want to have the option to order bulk or finished “pre-pandemic” vaccine from both facilities, understanding that in the event of a pandemic, only one facility could be allocated to supply pandemic vaccine to

HHS?

Selection of a facility will be based on what is proposed in the response to this RFP as well as the proposal submitted by the awardee in response to an individual

TOR.

No

CLINs 0008 to 0012 are to be priced per container rather than per lot; because yield may vary according to the seed virus, would HHS accept pricing that is linked to varying yield categories (for example, below average, average, above average)?

No, please provide pricing based on the information in the RFP and in accordance with section B.2. No

RFP No. 11-100-SOL-00020

No. Question Response Solicitation Revision

Solicitation 11-100-SOL-00020

Questions and Responses Number 2 Acquisition of MCMs for Pandemic Influenza Preparedness and Response

In response to question 30, BARDA indicated that “in order to receive the minimum order guarantee as listed in Section B.3, successful offerors must respond to at least one (1) TOR.” This implies that an awardee may decide to never respond to a TOR for the life of the contract, but that the awardee is therefore not eligible for the minimum award amount. This appears to also apply to TORs for the minimum amount, 1 Lot of CLIN 1. Based on these interpretations, can you clarify that an awardee is not required to respond to a TOR for only 1 Lot of CLIN 1 materials? Can you further clarify that if an awardee decides not to submit an offer in response to a TOR for that minimum amount, that the awardee would still be eligible to respond to TORs for other CLINS under the contract?

The minimum guarantee of 1 Lot of CLIN 0001 is the guarantee of the USG to the awardee(s). Awardees may receive more orders, via individual task orders awarde.

Beyond the minimum guarantee, an awardee may choose, as detailed in Section H.18 when or when not to respond to TORs.

No

In response to question 84, BARDA decided not to add FAR 52.225-5, “Trade Agreements.” Would BARDA consider adding it but applying it only to the CLINS requiring delivery of supplies, some of which may be manufactured overseas?

Section I.1.a has been amended. FAR 52.225-1 has removed from the RFP. FAR 52.225-5 and FAR 52.225- 6 has been added to the RFP

Yes

In response to question 55, BARDA stated that validation of HI and MN assays are required but there is no funding for these activities. Since this CLIN will be fixed price, and both the contract and the task orders will be competed to ensure that the fixed prices offered are fair and reasonable, shouldn’t offerors have the flexibility to propose and price these assays subject to BARDA’s proposal evaluation process?

No, all costs should be included in the fixed price listed in Section B.2. No

RFP No. 11-100-SOL-00020

No. Question Response Solicitation Revision

Solicitation 11-100-SOL-00020

Questions and Responses Number 2 Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Page 12, Section C.3. Additional Requirements states that, “when a contractor manufactures outside the US, the bulk vaccine, adjuvant and filled containers shall be shipped to the US as soon as the lots are released.” Does this mean that CLIN006: Storage of Bulk Lot(s) of Vaccine and/or Adjuvant, CLIN007A and 0007B: Storage of Bulk Lots of Vaccine and/or Adjuvant and CLIN0013 – Storage and Stability in Final containers of CLINS 0008-0012 and CLIN0015 – Disposal from Prior Contracts does not apply to material produced internationally?

All of these CLINS apply to the material or products produced internationally and shipped to the United States.

No

HHS has indicated in response to Question 6 that master and working virus seeds ordered under CLIN 0001 will become property of the USG. Will manufacturers be able to produce multiple working seeds from a given master seed, some of which will not be owned by the USG?

Yes No

The RFP states (on page 10) that the size of the lot will be defined by the manufacturers (number of eggs, bioreactor size in liters, etc.). However, different manufacturer’s processes and virus strain will impact lot yields. a. We are concerned that defining a lot by the number of eggs or by the bioreactor size will not allow HHS to compare one offer to another. Please explain how HHS intends to evaluate unit pricing under CLINs 0002-0005. b. Is it the expectation of HHS that each Offeror will provide an estimated number of doses per lot in order to facilitate a comparison of each offer?

Please provide pricing based on the information listed in the RFP. Pricing should be based on an average yield for CLINS 0002 - 0004. The Government utilizes several methods to determine a fair and reasonable price. See FAR 15.4 Contract Pricing.

No

RFP No. 11-100-SOL-00020

No. Question Response Solicitation Revision

Solicitation 11-100-SOL-00020

Questions and Responses Number 2 Acquisition of MCMs for Pandemic Influenza Preparedness and Response

HHS has indicated in response to Question 41 that Offerors may propose tiered pricing based on number of lots purchased. In order to more easily compare offers, would HHS consider expanding CLINs 0002-0005 into subCLINs (as applicable) to reflect the HHS's own desired tiers of maximum quantity ranges (as was done in Amendment 2 for CLINs 0008-0012)?

It is the discretion of the offeror whether or not tiered pricing will be offered. It is not a HHS requirement, therefore it is not necessary to revise CLINs 0002-0005.

No

Further to Question 44 a., except for discretionary movement of stored material or a breach of the storage contract obligations (e.g., to maintain cGMP), please confirm that the risk of loss during storage under CLINs 0006 (Storage of Bulk Lot(s) of Vaccine and/or Adjuvant) and 0007A/B (Storage of Bulk Lots of Vaccine and/or Adjuvant from Prior Contracts) is with the Government.

Individual terms regarding the storage of product will be negotiated at the time of task order award. Vendors should assume for pricing purposes that risk of loss will not be offered.

No

Further to Question 63, we understand that exact delivery timing will be set out in each TOR. However, for planning purposes, can HHS please provide estimated delivery times for CLINs 0002-0005 during pre-pandemic periods?

No No

Further to Question 62, please confirm that the language in Section G.6.b.1 (Payment Conditions) does not provide HHS with an extra contractual basis for revoking Acceptance, beyond those stated in FAR 52.246-2(k).

As stated in Section G.6.b.1, products that does not meet any condition outlined in the contract - FAR 52.246-2 or otherwise stated in the resulting contract - will be subject to replacement at no cost to the USG.

RFP No. 11-100-SOL-00020

No. Question Response Solicitation Revision

Solicitation 11-100-SOL-00020

Questions and Responses Number 2 Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Further to Questions 35 and 69, please answer the following: a. Will the ordering method specified in Section H.18 (Method of Ordering) apply to HHS's purchases under all CLINs? If not, please specify which CLINs are governed by Section H.18 and which are not. We note that Section H.18 refers to the performance of "studies," which might suggest that the ordering method in Section H.18 only applies to CLINs 0016 (Influenza Vaccine and/or Adjuvant Animal Testing) and 0017 (Influenza Vaccine and/or Adjuvant Clinical Testing). b. Will an awardee responding to a TOR be permitted to submit pricing in a TO proposal that is different from the pricing established in the awardee's IDIQ contract? If so, is it HHS's expectation that the TOR process will lead to TO pricing that is more favorable than the IDIQ contract pricing? c. Section H.18 (Method of Ordering) states that "Business proposals shall include appropriate support for all costs proposed as necessary for performing the task." Given that each order will be made on a firm-fixed price basis (see Section B.3.1), please further clarify the information that HHS intends to receive in a business proposal submitted in response to a TOR.

a. Yes, the ordering methods applies to all of the CLINs. b. No, with the exception of CLIN 0016 and 0017, unless pricing offered is lower than what is listed in the CLINs at the time of award. c. H.18 has been modified

Yes

Section "B.3 CONTRACT TYPE" is included on the Amendment 2 List of Changes to the RFP, however there doesn't appear to be a change to this section. Please clarify.

Under Amendment 0002, the language in B.3 CONTRACT TYPE was changed from the original language.

No

Section "C.2 Detailed Description of CLINs": CLIN 0002 (Non-GMP Influenza Vaccine: Pilot Lot(s)) is included on the Amendment 2 List of Changes to the RFP, however there doesn't appear to be a change to this section. Please clarify.

Under Amendment 0002, the language in C.2 Detailed Description of CLINS (0002)was changed. Please review the original RFP and Amendment 0002 in detail.

The change was minor.

RFP No. 11-100-SOL-00020

No. Question Response Solicitation Revision

Solicitation 11-100-SOL-00020

Questions and Responses Number 2 Acquisition of MCMs for Pandemic Influenza Preparedness and Response

Section "C.2 Detailed Description of CLINs": CLIN 0013 (Storage and Stability in Final Containers of CLINS 0008- 0012) is included on the Amendment 2 List of Changes to the RFP, however there doesn't appear to be a change to this section. Please clarify.

Under Amendment 0002, the language in C.2 Detailed Description of CLINS (0013) was changed. Please review the original RFP and Amendment 0002 in detail.

The change was minor.

No

In light of the complex nature of the RFP and because there will be a delay in progressing our proposal until we receive USG responses to additional questions we’ve submitted, we will require more time to finalize our proposal and to obtain senior management approval for its submission.

Subsequently, will the USG consider extending the due date by just one week to April 27, 2012?

No No

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