RFP 75N93024R00004 Questions-Responses.pdf

Vaccine (and Other Biologic) Manufacturing Services for Infectious Diseases RFP 75N93024R00004 Questions and Responses

Issued By NIAID April 3, 2024

Number Question Government Response 1 For previous HHS proposals the SBCX help desk has told us that in order to submit our Small Business Subcontracting Plan that the Contracting Officer needs to submit an invitation to us. Please confirm that you will provide us the needed invitation and when it will be provided.

After all proposals are evaluated, any Offerors determined to be within the Competitive Range will be sent an invitation to access SBCX and submit a Small Business Subcontracting Plan at that time.

2 Regarding the Small Business Subcontracting Plan, at what level should we submit the plan – at the IDIQ level, at the Task Area level, or at the Task Order level?

At the IDIQ Level.

3 Can the following sections be separated from the technical overview and plan (not counting towards the limited page count for that section): Enhancing reproducibility through rigor and transparency, Data Management and sharing plan, Dual use research of concern, Vertebrate animal section, financial conflicts of interest, and Past Performance.

No; however, floor plans may be included in the Appendix and are not part of the page limit.

4 Please confirm if the Vertebrate Animal Section is required for this RFP response or whether the requirement will be removed, as research with live vertebrate animals is not contemplated in any of the sample Task Areas.

• The Vertebrate Animal Section was included in the event that a mouse or other type of potency assay was required.

• Offeror may simply state whether they support non-clinical and/or preclinical work either directly or through subcontracts or vendors.

5 We became aware of a solicitation by the NIAID for manufacturing services for infectious diseases. We have a novel vaccine candidate in pre-clinical development and would like to manufacture it for use in clinical trials. Can you tell me if your solicitation of services might be appropriate?

• No. This RFP is to identify organizations that will provide a “fee for service” support for vaccine development and manufacture of a number of vaccine candidates that arise from a wide variety of vaccine developers.

6 For Solicitation Number 75N93024R00040, the timeline is very short, is this for facilities already performing vaccine manufacturing?

• For Solicitation Number 75N93024R00004, the proposal submission date was extended two months from March 18, 2024 to May 17, 2024 to allow for maximum participation and proposal consideration.

• Offerors will be evaluated for “Appropriateness and adequacy of facilities, equipment, space and other resources including those of proposed subcontractors/consultants for accomplishing the tasks outlined in the Statement of Work and the overall objectives of the solicitation.”

• Offerors shall clearly identify current facilities and equipment.

• Offerors may describe facilities and equipment that are under construction or renovation along with the jkdate that facility will be functional.

7 There seem to be two separate sets of instructions for outlining the technical proposal as defined in the RFP Section (Page 82) and in Attachment 7 (Attachment 7, Page 2). Also, the Technical Proposal Table of Contents appears to have two sets of contents: Sections 1, 2, and 3 are followed again by Sections 2 and 3 with different instructions. Which set of instructions in Attachment 7 should we follow?

• Section L spans pages 68 to 100 of the RFP and provides general instructions and content required for proposals.

1. 2.a Instructions to Offerors – General Instructions

• Contains general information

2. 2.b Technical Proposal Instructions –

• Points 1-3 identify content that should be included in proposal. Note that Attachment 7 provides additional information and specific instructions for the proposal.

3. 2.c Business Proposal Instructions

• Contains information for the Business proposal.

• Attachment 07 Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents contains specific information for proposals.

1. Format for each Task Area specific Technical Proposal is provided as defined below:

2. Section 1: Title Page and Introduction

• Note that the page limit will be removed for Section

1. There should be no page limit for Section 1.

3. Section 2: Technical Overview and Plan

• High level, company wide information provided specific for the appropriate Task Area.

4. Section 3: Kickoff Task Order and Sample Task Order Proposals

• The proposal should have a complete Task Order proposal section for the Kickoff Task Order and subsequent Sample Task Orders.

• NOTE: the Business proposal should have a separate Task Order and Sample Task Order section for each Kickoff Task Order and Sample Task Order proposal in the Technical proposal.

• A single and complete 15-page proposal shall be included for the Kickoff Task Order.

• A single and complete 15-page proposal shall be included for one or both of the additional sample Task Orders in each Task Area. The Offerors must propose to one sample Task Order and may choose which Sample Task Orders to include in their proposal such as C-1, C-2, or both.

• However, the proposals shall respond to the entire Task Order and Sample Task Order including the base and option if applicable.

5. Technical Instructions

• Section 1: Title Page and Introductions o There are no additional technical instructions.

• Section 2: Technical Overview and Plan o Additional information for the offeror is provided for task area proposal section.

• Section 3: Kickoff Task Order and Sample Task Order Proposals

Additional information for the Offeror is provided for each Task Order and Sample Task Order proposal.

8 Where in the proposal response(s) should an Offeror response to Task Order 01: CONTRACT KICKOFF? For example, if an Offeror bids on all four task areas, should that Offeror include its response to Task Order 01 in a particular task area response, in all four responses, or in an entirely separate response document?

• The proposal should have a complete Task Order proposal section for the Kickoff Task Order and subsequent Sample Task Orders.

• NOTE: the Business proposal should have a separate Task Order/Sample Task Order section for each Kickoff Task Order and Sample Task Order proposal in the Technical proposal.

• A single and complete 15-page proposal shall be included for the Kickoff Task Order.

• However, the proposals shall respond to the entire Task Order and Sample Task Order including the base and option if applicable.

9 When responding to a Task Area with multiple listed Sample Task Orders, must the offer provide technical responses/business proposals for all listed Sample Task Orders? Or can they select just one of the Sample Task Orders for the Task Area? For example, if they are applying to Task Area C, do they need to respond to both Sample Task Order C-1 and Sample Task Order C-2?

• A single and complete 15-page proposal shall be included for one or both of the additional sample Task Orders in each Task Area. The Offerors must propose to at least one sample Task Order and may choose which Sample Task Order(s) to include in their proposal such as C-1, C-2, or both.

• A single Technical and a single Business proposal shall be provided for each individual Task Area

10 Please provide a list of the Technical and Business proposals expected for offerors submitting proposals for all task areas (or orders).

• A single Technical and a single Business proposal shall be provided for each individual Task Area

• An Offeror may provide a single Technical proposal and a single Business proposal for EACH SPECIFIC TASK AREA A, B, C and/or D. To further clarify, each Task Area response will require a Task Area-specific Technical proposal and a Task Area specific Business proposal.

11 RFP Section L (p. 83-85) and Attachment 07 (p144 of 156) – The terms “Task Area” vs “Task Order” seems to be interchangeable in some cases, especially in Section L Instructions to Offerors and Attachment 7 Additional Technical Proposal Instructions. Do we provide ONE overall technical proposal for the IDIQ, another for Task Order 01 (Contract Kick off, page 122), plus one for each Sample Task Order (STO) or one for Each Task AREA, containing two

• A single Technical and a single Business proposal shall be provided for each individual Task Area.

• An Offeror may provide a single Technical proposal and a single Business proposal for EACH SPECIFIC TASK AREA A, B, C and/or D. To further clarify, each Task Area response will require a Task Area-specific Technical proposal and a Task Area specific Business proposal. • A single and complete 15-page proposal shall be similar proposals imbedded for each STO under that Task Area? Please clarify the expected number of proposals (Total number of Technical and Business proposals) required if we plan to respond to all task orders.

included for one or both of the additional sample Task Orders in each Task Area

If responding to all task areas, Offerors are expected to submit at least (4) Technical and (4) Business proposals. Contained in Section 3 of each technical proposal will be the offerors detailed response to each task/sample task. See response to Question 14 regarding proposal page count limits.

12 Do floor plans need to be included in section 3 for the Task Area C technical proposal, or can these be included in the Appendix?

Floor plans shall be included in an attachment and are not included in page limits.

13 Please clarify the length of the resume/biosketches. This section has contradicting information: 1) Limit resumes to 3 pages plus 2 additional pages to provide selected references or publications relevant to the scope of the Task Order. Vs. 2) Limit bio sketches to 1 page and only include information relevant to the scope of the Task Order. Are biosketches and resumes the same?

Per RFP Amendment 3, only biosketches are required, not resumes.

The RFP limits biosketches to 1 page. Biosketches should only include information relevant to the scope of the Task Order.

14 Task Area Page Limit Questions: Please note that RFP Amendment 3 revises page number limits.

• SECTION 1: TITLE PAGE AND INTRODUCTIONS has a 10-page limit. However, Attachment 1, Formatting and Page Limitations, B Page limitations states "2. Total page count does not include: Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section. Can the government please provide clarity on title page, table of contents and other front matter?

• The technical proposal length for Task Area C is 70 pages. If you add section 1 (10 p. max), section 2 (15 p.

max), and section 3 (30 p. max), you end up with 55 pages; how are the remaining 15 pages assigned?

• Task Area A: Product Development Plans and Other Analyses (Landscape, Feasibility) o Section 1 Title Page – no page limit o Section 2: Technical Overview and Plan – 10 page maximum o Section 3: Sample Task Order Proposals

Kickoff Task Order Proposal (Task Order 01)– 15 page maximum

No sample task order o Page Limit 25 with no sample task order proposal.

• Task Area B: Product Development & Manufacture of Non- GMP Material o Section 1 Title Page – no page limit o Section 2: Technical Overview and Plan – 10 page maximum o Section 3: Sample Task Order Proposals

Kickoff Task Order Proposal (Task Order 01)– 15 page maximum

• What is the page limit for task order 01, contract kickoff? The page limit for sample TOs is 15 pages, but the kickoff is not a sample TO.

Single Sample Task Order Proposal – 15 page maximum

Both Sample Task Order Proposals – 30 page maximum o Page Limit 40 pages for one sample task order proposal and 55 pages if contains proposals for both sample task orders.

• Task Area C: Bank Optimization and Master Banks o Section 1 Title Page – no page limit o Section 2: Technical Overview and Plan – 15 page maximum o Section 3: Sample Task Order Proposals

Kickoff Task Order Proposal (Task Order 01)

– 15 page maximum

Single Sample Task Order Proposal – 15 page maximum

Both Sample Task Order Proposals – 30 page maximum o Page Limit 45 pages for one sample task order proposal and 60 pages if contains proposals for both sample task orders.

• Task Area D: Engineering and GMP Material o Section 1 Title Page – no page limit o Section 2: Technical Overview and Plan – 15 page maximum o Section 3: Sample Task Order Proposals

Kickoff Task Order Proposal – 15 page maximum

Single Sample Task Order Proposal – 15 page maximum

Both Sample Task Order Proposals – 30 page maximum o Page Limit 45 pages for one sample task order proposal and 60 pages if contains proposals for both sample task orders.

15 Sample Task Order B-1. What expression host was used in the pilot study? Can the government please identify the type of Cell Line involved in this Sample Task Order?

Offeror shall suggest an appropriate cell line and provide rationale for the value of that cell line.

16 Sample Task Order B-1: For cost estimating purposes, is the refolded 1st generation product active, and what is the yield (mg/liter culture)?

• The vaccine candidate is active after refolding.

• No additional information will be made available to any of the offerors. The Offerors shall provide Technical and Business proposals based on the information provided. Offerors shall clearly identify any assumptions they made to address these issues.

17 Sample Task Order B-2, Attachment 5 pages 9-10. Guidance on routes of exposure and risks from occupational exposure to the novel enterovirus. What were the symptoms of infection? Are BSL2 controls appropriate with this being a novel pathogen?

• Assume the virus is BSL2 and the route of infection is respiratory.

• No additional information will be made available to any of the Offerors.

18 Sample Task Order B-2 scope is to manufacture and characterize non-GMP inactivated virus (challenge material and bulk material), whereas in the background and in the technical requirement and assumptions it is suggested that active virus material (meaning non-inactivated) virus is needed. Can you confirm the scope is to manufacture inactivated virus material?

• There was a typo in Sample Task Order B-2. There is no requirement for active virus.

19 Sample Task order B-2 does not specify the lot sizes for challenge and bulk materials. For cost-estimating purposes, what are the lot sizes for challenge and bulk virus?

• The Offerors shall provide Technical and Business proposals based on the information provided.

• Offerors shall clearly identify any assumptions they made to address these issues.

20 Sample Task Order D-1. Is Sample Task Order (STO) D1 for Drug Product services or Drug Substance? If Drug Substance can you specify what type of cell line is targeted in this

STO?

• The Sample Task Order D-1 has sufficient information to address the questions provided above.

• No additional information will be made available to any of the Offerors. The Offerors shall provide Technical and Business proposals based on the information provided. Offerors shall clearly identify any assumptions they made to address these issues.

21 Clarifications regarding Sample Task Order D-1. • NIAID seeks to determine the capabilities of offerors to manufacture an engineering lot and GMP lot of material to support a Phase I clinical trial.

• NIAID believes it is best for the Offeror to pick a single representative vaccine candidate and platform that best demonstrates their expertise and capabilities.

• NIAID assumes that the Offeror will pick a project that highlights their strengths and focuses on specific platforms and specific types of candidates.

• Offeror shall manufacture:

o Appropriate amount of engineering lot material that is filled and stored in a manner proposed by the Offeror.

o Not less than 1500 single use vials of a vaccine candidate to support both a toxicology study and a dose finding Phase I clinical trial that involves a prime/boost administration schedule.

• Offeror shall propose deliverables to demonstrate their expertise and capabilities to the reviewers.

• No additional information will be made available to any of the offerors. The Offerors shall provide Technical and Business proposals based on the information provided.

• Offerors shall clearly identify any assumptions they made to address these issues.

22 FAR Part 16.301-3 restricts the use of a cost-reimbursement contract type, stating that "a cost-reimbursement contract may be used only when the contractor’s accounting system is adequate for determining costs applicable to the contract or order".

In the event a firm is only able to support Firm Fixed-Price task orders under this IDIQ, and establishes their intent in writing to do so in their proposal, would NIAID consider providing an exception to the requirements that are relevant only to cost-reimbursable contracts?

If a Firm Fixed Price is proposed by an Offeror, the requirement that the contractor’s accounting system is adequate for determining costs applicable to the contract or order is not applicable.

23 Based on the description of each Task Area included in the SOW, Task Area A, specifically, seems uniquely suited to a Firm, Fixed-Price structure, as a scope with defined deliverables in the form of Product Development Plans (PDPs) can reasonably be expected to be estimated with

NIAID will consider proposals from offerors who propose a cost-reimbursement or a Firm Fixed Price type contract for Task Area A. If submitting a Firm-Fixed Price proposal in support of Task Area A only, Cost-Reimbursement requirements shall not apply to any resultant award.

sufficient accuracy for a fixed-pricing by Task Order. Would NIAID consider a revised contract structure that establishes Task A as FFP, thereby removing the need to extend cost-reimbursable requirements to offerors who receive an IDIQ contract to support Task A only?

24 Offerors are instructed to provide a breakdown of direct and indirect costs and profit (including direct labor rates, fringe benefits, overhead, and G&A expenses).

Would NIAID also please clarify how offerors should address these requirements in the event they do not maintain accounting systems or pricing methodologies that are able to generate the direct and indirect costs and profit percentages that underlie their pricing?

Offerors who proposed a Firm Fixed Price contract do not have to breakdown direct and indirect costs and profit, direct labor rates, fringe benefits, overhead, and G&A expenses. However, the offeror must price the specific work for each task.

25 Can NIAID please clarify what is the scope of the Technology Checklist? It is not clear what type of technology and whether it refers to technology associated with the manufacturing of the vaccine or technology related to the development of the product development plan

The Technology Checklist requirement was contained in Attachment 5: Sample Task Orders TASK AREA A: Product Development Plans and Other Analyses Sample Task Order A-1: Product Development Plans. The Sample Task Order for Task AREA A has been removed in RFP Amendment 3 and is no longer applicable.