QA for Follow Stockpile - IDIQ 8-6-21 FINAL.pdf

BARDA

RFP: 75A50121R00013

Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Questions and Responses

Date: 8/06/2021

Question No. Reference Question

Category Questions Response

1 SECTION A - Solicitation, Offer and Award Form, SF 33, pg. 2 of 140 and B.3. CONTRACT TYPE pg. 14 of 140

Contract Type

The Solicitation contemplates the award of multiple noncommercial Indefinite Delivery Indefinite Quantity (“IDIQ”) contracts. Given influenza vaccines and adjuvants qualify as commercial items--that is, they are items “of a type” customarily used by the general public or by non-governmental entities for purposes other than governmental purposes, and have been sold, leased, or licensed to the general public--will the Government consider acquiring these products and related services under Federal Acquisition Regulation (“FAR”) Part 12 procedures?

Pre-pandemic vaccines are not marketed products.

2 SECTION A - Solicitation, Offer and Award Form, SF 33, pg. 2 of 140, blocks 12-15

Administrativ e

The current versions of the solicitation, specifically Standard Form 33, uploaded to SAM.gov do not download properly and blocks 12 - 15 appear to be corrupt prohibiting the offeror to complete the blocks as required when submitting a proposal to the Government. Will a clean version of SF33 be provided with a future amendment?

A legible copy of page 2 will be provided.

B.1. SUPPLIES OR SERVICES AND PRICES/COSTS;

BRIEF DESCRIPTION OF SUPPLIER OR SERVICES, pg. 6 of 140, 4th paragraph

Contract Type

The Solicitation establishes a minimum guarantee of $50,000 per IDIQ contract, but does not include an estimated maximum value for all IDIQ contracts awarded under the Solicitation. Does BARDA have an estimated maximum value for the contemplated IDIQ contracts awarded in response to Solicitation?

An estimated maximum value for the contemplated IDIQ contracts awarded is TBD.

B.2.d.-f. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) pg. 7-14 of 140, CLINs 0001-0018, 1001-1018, 2001-2018

Source Evaluation Are offerors required to bid on all CLINs? Offerors are not required to bid on all CLINs if Offerors do not have the capabilities to provide supplies and services as described in the CLIN.

B.2.d.-f. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) pg. 7-14 of 140, CLINs 0001-0018, 1001-1018, 2001-2018

Contract Type

The CLINs are identified as FFP, Cost, or NSP. Are the Cost CLINs intended to be CPFF, or simply cost reimbursable? Cost Reimburseable

B.2.d.-f. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) pg. 7-14 of 140, CLINs 0001-0018, 1001-1018, 2001-2018

Solicitation Please clarify whether BARDA intends to solicit for a CLIN related to Combination Pack – Packaging (antigen and adjuvant).

BARDA does not intend to solicit for a CLIN related to a Combination Pack. The Offeror is able to propose additional packaging sub-CLINs for USG consideration if they choose.

B.2.d.-f. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) pg. 8-12 of 140, CLINs 0006E, 1006E, 2006E

SOW Please clarify the packing expectations and requirements for CLIN 0006E. Does BARDA expect 10 or 25 dose packing?

Packing expectations and requirements will be provided by BARDA at the time of request for task order response or in the event of a Public Health Emergency.

B.2. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) d. BASE PERIOD, pg. 7-9 of 140, CLINs 0001-0006, 0009, 00017

CLINs Is the stated maximum quantity defined as the maximum on a per month basis, a per year (12 months) basis, or on a three year (36 month) basis? Please refer to Section B.2, d, e, f which identifies the period for the maximum quantity.

B.2. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) d. BASE PERIOD, pg. 7-9 of 140, CLINs 0001-0017

CLINs What is the definition of the unit "LOT" for the identified CLINs, as applicable? Lot size is defined by the Offeror. Lot size in terms of liters and grams (range) should be described.

B.2. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) d.-f., pg. 7-12 of 140, CLINs 0007, 0017, 1007, 1017, 2007, 2017

CLINs What is the definition of the unit "final container" for the listed CLINs, as applicable? Each Offeror will have a different final container with associated product specifications, so the term 'final container' is Offeror-defined.

B.2. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) d.-f., pg. 7-12 of 140, CLINs 0018, 1018, 2018

Contract Type

CLIN 0018, Emerging Pathogens, is listed as “unpriced.” Does the Government anticipate negotiating any work ordered under CLIN 0018 on a firm-fixed price basis only? The CLIN may be negotiated as FFP or cost reimbursable.

BARDA

Question & Answer - RFP # 75A50121R00013 for the requirement “Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Questions and Responses

Date: 8/06/2021

Question No. Reference Question

Category Questions Response

BARDA

Question & Answer - RFP # 75A50121R00013 for the requirement “Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

B.3. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT TYPE, 1. Delivery order and Task Order Type, pg.

14 of 140, top third of page

Contract Type

The Solicitation states that “[t]he Government contemplates awarding of multiple Indefinite delivery and indefinite quantity (ID/IQ) hybrid contracts with firm-fixed-price and cost reimbursable task/delivery orders for vaccines for influenza and/or emerging pathogens.” Does the Government contemplate the award of Cost Plus Fixed Fee (CPFF) task/delivery orders, or simply cost reimbursable task/delivery orders?

Cost Reimburseable

B.3. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT TYPE, 1. Delivery order and Task Order Type, pg.

14 of 140, top third of page

Contract Type

In lieu of cost-reimbursable CLINs, is the Government willing to award time-and-materials and/or labor hour and/or not-to-exceed type CLINS that would avoid/limit the parties having to do business on a cost-reimbursement basis?

No

B.4. SUPPLIES OR SERVICES AND PRICES/COSTS;

ADVANCE UNDERSTANDINGS: 3. Vendor Production Capacity, pg. 15 of 140, top of page

SOW

As BARDA understands, production capacity during a pandemic may be dependent on a number of potential future constraints. Please clarify whether a response to the advance understandings portion of B.4.3. should account for potential constraints like obligations to non-U.S. markets?

The Offeror should account for the potential constraints, e.g., obligations to non-US markets.

B.4. SUPPLIES OR SERVICES AND PRICES/COSTS;

ADVANCE UNDERSTANDINGS: 3. Vendor Production Capacity, pg. 15 of 140, top of page

SOW

As BARDA understands, production capacity during a pandemic may be dependent on a number of potential future opportunities. Please clarify whether a response to the advance understandings portion of B.4.3. may account for potential opportunities like the future availability of expanded vaccine delivery options (e.g. non cell-based and non egg-based vaccines) that are not yet approved, but developed by the offeror during the performance of the contract?

Refer to the RFP Scope of Work. The Offeror must demonstrate successful experience in the manufacturing of influenza vaccine by: Hold a US influenza virus vaccine license OR Have Developed an influenza vaccine as evidenced by submission of a BLA to the US FDA for seasonal or pandemic influenza virus vaccine

B.4. SUPPLIES OR SERVICES AND PRICES/COSTS;

ADVANCE UNDERSTANDINGS: 4. Schedule of Labor Category Hourly Rates for TBD CLINs. pg. 16 of 140, top of page

Pricing

The Solicitation requires the offeror to propose hourly rates for certain categories of labor, but it does not define “hourly rate.” Thus, it is not clear whether the offeror is required to propose hourly rates that are fully burdened (with cost, fringe, overhead, general and administrative, and profit) or not. Are offerors permitted to propose fully burdened rates?

Offeror to provide fully burdened rates

B.4. SUPPLIES OR SERVICES AND PRICES/COSTS;

ADVANCE UNDERSTANDINGS: 4. Schedule of Labor Category Hourly Rates for TBD CLINs. pg. 16 of 140, top of page

Pricing What will these labor category hourly rates be used for? Reference Section M.3. Evaluation Criteria

B.4. SUPPLIES OR SERVICES AND PRICES/COSTS;

ADVANCE UNDERSTANDINGS: 4. Schedule of Labor Category Hourly Rates for TBD CLINs. pg. 16 of 140, top of page

Pricing Is the successful contractor required to use the proposed rates and labor categories for performing/pricing future work? Offerors will use the unit price in Section B.2 for the contract's period of performance.

B.4. SUPPLIES OR SERVICES AND PRICES/COSTS;

ADVANCE UNDERSTANDINGS: 5. Analytical Laboratory Testing/Assay-CLIN 0011-Pricing per TimePoint. pg. 16 of 140, middle of page

Contract Type

This provision requires offerors to provide “pricing” for various testing/assays. The CLIN tables in B.2, however, identify CLIN 0011 as a Cost CLIN. Are offerors expected or permitted to propose estimated costs and a fixed fee for the testing/assays per time point, or are they expected to propose fixed prices in table B.4.5.?

Table B.4.5 should include a fixed price per assay per time point.

B.7. SUPPLIES OR SERVICES AND PRICES/COSTS;

PROVISIONS TO APPLICABLE COSTS, pg. 17-18 of 140, begins at bottom of page 17

Pricing

This provision restricts the types of costs that are allowable--and hence reimbursable--under the contemplated contracts. It is not clear whether this provision only applies to direct costs incurred in the performance of the cost reimbursement CLINs or whether it also applies to indirect costs as well. If it applies to indirect cost as well, this will require the contractor to rework its indirect cost rates. Could you please clarify if B.7 applies only to direct costs incurred in the performance of a cost reimbursement task/delivery order?

Allowable costs are defined in the FAR as costs that are reasonable and allocable to the contract, per the terms of the contract at issue, Cost Accounting Standards and the FAR.

(See FAR 31.201-2). Although this is a broad definition, FAR Section 31 specifically addresses many types of costs a contractor may incur.

C.2.1. STATEMENT OF WORK; Detailed Description of Contract Line Item Numbers (CLINs), CLIN 0005, pg. 21 of 140, 3rd bullet; CLIN 0006, pg. 22 of 140, 8th bullet

Source Evaluation

Detailed descriptions of CLIN requirements in C.2.1 reference stability testing requirements. For example, CLIN 0005 requires contractors to set aside adjuvant clinical or commercial bulk lot samples for stability study testing for at least 120 months and CLIN 0006 requires contractors to set aside formulated and filled antigen and/or adjuvant samples for stability study testing for at least 120 months. Please clarify whether BARDA will accept offers where stability testing will only be conducted for a term less than 120 months.

Offerors should justify and explain in detail any stability programs less than 120 months.

Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Questions and Responses

Date: 8/06/2021

Question No. Reference Question

Category Questions Response

BARDA

Question & Answer - RFP # 75A50121R00013 for the requirement “Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

C.2.1. STATEMENT OF WORK; Detailed Description of Contract Line Item Numbers (CLINs), CLIN 0006, pg. 22 of 140, 6th & 7th bullets

SOW

Please clarify the serialization and labeling requirements for CLIN 0006; are HHS-approved labels intended to be fixed to individual filled final container vials or whether packed boxes are to receive HHS-specific labeling?

Additionally, as adjuvant is not a stand-alone product and serialization is applied to the unit of sale, does the response to the aforementioned question, specifically the serialization requirement, apply to the labeling and cartoning of adjuvant as well? If so, can you please provide an explanation as to why serialization applies to adjuvant?

Expectations and requirements will be provided by BARDA at the time of request for task order response or in the event of a Public Health Emergency.

C.2.1. STATEMENT OF WORK; Detailed Description of Contract Line Item Numbers (CLINs), CLIN 0012: Non-Clinical Studies and CLIN 0013: Clinical Studies, pg. 24 of 140, 2nd and 3rd major headers

Source Evaluation

Please confirm whether BARDA will allow a Contractor to conduct clinical studies or non-clinical studies through a subcontracted research organization. Work may be sub-contracted.

C.2.1. STATEMENT OF WORK; Detailed Description of Contract Line Item Numbers (CLINs), CLIN 0018: Emerging Pathogen, pg. 26 of 140, single line under "CLIN 0018..."

SOW

The description of CLIN 0018 states that “[t]he contractor shall perform activities as required by HHS and as specified in an RTOR.” Can the Government provide any additional guidance as to the anticipated scope of work under CLIN 0018?

Additional guidance will be provided at the time of request for task order response.

C.2.1. STATEMENT OF WORK; Detailed Description of Contract Line Item Numbers (CLINs), CLIN 0018: Emerging Pathogen, pg. 26 of 140, single line under "CLIN 0018..."

SOW

Based on the previous question - if for example an offeror does not bid or propose against CLIN 0012 (Non- Clinical Studies) and CLIN 0013 (Clinical Studies), can BARDA still order Clinical or Non-Clinical Studies under CLIN 0018?

Additional guidance will be provided at the time of request for task order response.

26 SECTION H - SPECIAL CONTRACT REQUIREMENTS, pg.

48-74 of 140, all

Provisions/ Clauses

Section H does not include a clause addressing the PREP Act and confirming the contractor’s liability protection under the PREP Act. Please confirm that the HHS Secretary’s Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) regarding pandemic influenza will apply to any resultant contract consistent with the BARDA’s existing pandemic influenza contracts?

The PREP Act has been extended to December 31, 2022.

Reference:https://www.federalregister.gov/documents/2015/12/09/2015-31087/pandemic-influenza-medical-countermeasures-amendment

H.6 SPECIAL CONTRACT REQUIREMENTS;

ACKNOWLEDGEMENT OF FEDERAL FUNDING, c.

Subcontractors, pg. 51 of 140, 3rd paragraph

Administrativ e

Is the statement "Contractors shall require subcontractors to adhere to these requirements (Section H.7)…" referencing the wrong section? Should it refer instead to the current section, "H.6. Acknowledgement of Federal Funding"?

H.6 should be referenced not H.7

H.19. SPECIAL CONTRACT REQUIREMENTS; CLINICAL

AND NON-CLINICAL TERMS OF AWARD, pg. 60-63 of 140, all pages

Provisions/ Clauses

This clause provides the Government with unlimited rights to all protocols, data resulting from the execution of these protocols, and final reports funded by BARDA under this contract. Please clarify that these rights and any other rights as defined in the Rights in Data Clause in FAR 52.227-14 apply only to the technical data generated at the government’s sole expense in support of CLIN 00012 and CLIN 00013 and do not provide for unlimited data rights in any data provided in connection with items supplied under other CLINs or any other data not first produced in the performance of the contract.

Offerors should propose in accordance with FAR Clause 52.227-14 Rights in Data- General.

H.45. SPECIAL CONTRACT REQUIREMENTS; FOREIGN

TRANSFER OF ASSETS OR TECHNOLOGY, pg. 72-74 of 140, starts halfway down page

Provisions/ Clauses

This clause restricts the “transfer” of Assets and Technology (i.e., Technical Data, Computer Software, manufactured materials and Subject Inventions funded by the USG under the Contract) to foreign entities unless they are affiliates of the contractor. As written, the clause is ambiguous because the term “transfer” is not defined and could have multiple meanings. Could the Government please define or clarify what constitutes a transfer of an Asset or Technology to a foreign entity, and which types of transfers require Government concurrence?

Reference Post-award Transfer of Ownership of Assets or Technology in section H.45

30 SECTION I - CONTRACT CLAUSES, pg. 75 of 140, 6th listed clause

Administrativ e

FAR 52.203-18 (DEVIATION) (Feb 2015), Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements, was incorporated into and is superseded by the listed FAR 52.203-18 (Jan 2017) version of the clause. Will this deviation be removed from section I?

FAR 52.203-18 (DEVIATION) (Feb 2015) will be removed from Section I

31 SECTION I - CONTRACT CLAUSES, pg. 75 of 140, 12th listed clause

Administrativ e

It appears that, as listed in Section I, "FAR 52.204-16 - System for Award Management Maintenance (Aug 2020)" was accidently titled incorrectly. If the identified provision, FAR 52.204-16, will remain in the solicitation, please confirm that it is referring to the provision titled, "Commercial and Government Entity Code Reporting (Aug 2020)".

FAR Clause 52.204-16 will be updated to Commercial and Government Entity Code Reporting (Aug 2020)

32 SECTION I - CONTRACT CLAUSES, pg. 76 of 140, top of page

Provisions/ Clauses

Section I includes various clauses implementing Truthful Cost or Pricing Data Act requirements that may require an offeror to submit certified cost or pricing data. (i.e., FAR 52.215-10 through 52.215-21) Has the Government determined whether it expects adequate price competition, so that offerors need not submit certified cost or pricing data?

Clauses added to the RFP are as prescribed by FAR. Clauses will be updated at time of award

33 SECTION I - CONTRACT CLAUSES, pg. 74-79 of 140, top of

Provisions/ Clauses

Section I does not include a clause (i.e., FAR 52.230-1) addressing the potential applicability of the Cost Accounting Standards (“CAS”) to the resulting contract. Has the Government determined that CAS will not apply to the resulting contract?

Clause 52.230-1 will be added to Section I

Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

Questions and Responses

Date: 8/06/2021

Question No. Reference Question

Category Questions Response

BARDA

Question & Answer - RFP # 75A50121R00013 for the requirement “Acquisition of Medical Countermeasures (MCMs) for Pandemic Influenza and Emerging Diseases Preparedness and Response

K.4. REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS; Trade Agreements Certificate, pg. 83 of 140, top of page. SECTION I - CONTRACT CLAUSES, pg. 77 of 140, 12 lines from bottom of page

Provisions/ Clauses

The Solicitation contemplates the inclusion of the contract clause at FAR 52.225-1, Buy American-Supplies (Jan 2021) in the resulting contract at Section I. However, Section K specifically asks about compliance with the Trade Agreements Act by referencing the solicitation provision at FAR 52.225-6, Trade Agreements Certificate (May 2014) and requiring offerors to deliver U.S.-made or designated country end products or to indicate instances where neither U.S.-made or designated country end products will be delivered. Will the resulting contract also include the contract clause at FAR 52.225-5, Trade Agreements (Oct 2019), such that a successful offeror may deliver U.S-made or designated country end products?

The clause at 52.225-5, Trade Agreements, in solicitations and contracts valued at $182,000 or more, if the acquisition is covered by the World Trade Organization Government Procurement Agreement (WTO GPA) (see subpart 25.4) and the agency has determined that the restrictions of the Buy American statute are not applicable to U.S.-made end products. If the agency has not made such a determination, the contracting officer must follow agency procedures.

M.3. EVALUATION FACTORS FOR AWARD; Evaluation Criteria, III. FACTOR B - COST/PRICE, pg. 100 of 140, middle of page

Administrativ e

Given that "M.4 Relative Importance of Price and Other Evaluation Factors" includes reference to Factor C in "Factor B is more important that Factor C.", and that there are two "FACTOR B"s on the page, is the header for "...COST/PRICE" supposed to read "III. FACTOR C - COST/PRICE"?

M.3 Evaluation Criteria, Factor for cost/price should be Factor C.

B.2. SUPPLIES OR SERVICES AND PRICES/COSTS;

CONTRACT LINE ITEM NUMBERS (CLINs) d. BASE PERIOD, pg. 7-9 of 140, CLINs 0001-0018

CLINs

There are 18 CLIN items in the Base Period 36 month contract award. Clarification is needed if all tasks orders are expected to be completed in the 36 months or does BARDA expect only a certain number of items (i.e., stage of development) to be reached, e.g., master and working seed lot generation through non‐clinical studies but not clinical studies (CLIN0013), or will all 18 CLIN items be executed in the 36 months?

Offerors are not required to bid on all CLINs if Offerors do not have the capabilities to provide supplies and services as described in the CLIN. Guidance will be provided in the request for task order response.

37 SOW How many pandemic influenza strains would be expected to be assessed during the 36 month contract? This is difficult to predict, and guidance will be provided in the request for task order response based on USG need.

38 C.1 BACKGROUND; pg. 19 of 140; last sentence. SOW

RFP includes additional wording that allows companies with an existing, licensed influenza vaccine may respond with “a proposal for manufacturing of vaccines or adjuvants for use in responding to an emerging pathogen during a Public Health Emergency (PHE).” Does this licensed influenza vaccine platform also have to address the ability to use this manufacturing process for other non‐influenza pathogens as well?

Guidance will be provided in the request for task order response.

39 L.3.4 Factor B: Past Performance; pg. 92 of 140 Source Evaluation

In the section for Past Performance Questionnaire, the sentence stops short before telling where the instructions for providing references. Past Performance Questionnaire: A Past Performance Questionnaire must be sent by the Offeror to at least three (3) of the references for their response. It is the Offeror’s responsibility to ensure that the questionnaires are completed and returned to the Government by their references in accordance with the instructions provided in

Instructions are provided in L.1. Instructions for Submission to Offerors.