AMENDMENT 2 FINAL.pdf

AMENDMENT #2: RFP 75N95023R00037

The purpose of this Amendment is to:

1) Extend the deadline for submission of proposals. Section A.8. of the solicitation is amended as follows:

Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 pm local time on August 18, 2023.

Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

2) To distribute RFP questions and answers (See below)

3) Clarify that Attachment 2-Proposal_Intent_Reponse_Form should be returned to the Contract Specialist at michelle.cecilia@nih.gov by 3:00 pm local time on July 31, 2023.

4) The Statement of Work has been updated. For ease of review a clean and redlined version of the Statement of Work dated July 10, 2023 has been uploaded to Sam.gov.

See Attachment 3-REVISED_SOW (7.10.23)_clean and Attachment 3-REVISED_SOW (7.10.23)_redlined.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED

Questions and Answers/Clarifications

Q1. Given the specifics provided in the Sample Task Orders, they appear to be anticipated future procurements rather than “sample” TOs primarily provided for evaluation of the offeror’s proposal. Can the Government confirm if these TOs will be awarded after award of the master IDIQ contracts? This knowledge would impact the specifics of what information we might request from potential subcontractors.

A1. These are sample Task Order Requests for Proposals (TORFPs) only and WILL NOT result in actual task order awards. The responses to the sample TORFPs are used to assess the Offeror’s understanding of the types of requirements that the Government might have in future task orders, and the overall soundness, feasibility and completeness of the proposed approach to achieve the stated requirements.

Q2. Although a clear target of vg content has been specified for, are there any other specific expectations / acceptance criteria with regards to the final product e.g., Full / Empty viral particles ratio or other critical quality attributes?

A2. Offerors should address all requirements stated by the Government in their technical response to the sample TORFP. The Offeror may include in their response any additional critical quality attributes not otherwise specified by the Government that they deem relevant when describing their technical approach.

Q3. Regarding plasmid supply: will NCATS provide a sample of plasmid with GoI / REP-Cap9 / Helper or theoretical sequences? This would lead us to work with different partners/vendors for plasmid supply.

A3. The specific requirements of any future issued task orders may vary. In some cases, the Government may supply plasmids, while in other cases the Government may only be able to provide sequences. For the purposes of the response to the sample TORFP, Offerors should assume that they will need to generate the plasmids based upon sequences provided by the Government, and that the Government will not supply plasmid samples.

The intent of this RFP is to receive proposals from Offerors that fulfill the comprehensive range of requirements detailed within each Technical Area proposed upon. In cases where an Offeror may not be able to fulfill all requirements using purely internal resources, it is acceptable to propose partnering / subcontracting arrangements that would enable the Offeror to complement their own internal expertise and capabilities to provide that comprehensive support. Per the Additional Technical Proposal Instructions (See Attachment 7-Additional Technical Proposal Instructions_5.9.23), “Offerors proposing Subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed Subcontractors, and the expected advantages of such an approach.”

Q4. Is the expectation that analytical methods are qualified for Engineering Run material testing and release?

A4. The analytical methods do not need to be qualified for the Engineering Run, but they must be qualified for testing and release of cGMP material.

Q5. Will a Master Cell Bank or Working Cell Bank be provided for development and cGMP manufacture – or should that be generated as part of this Task Order?

A5. For the purposes of the response to the sample TORFP, Offerors should assume that they will need to generate the Master and Working Cell Banks, and that the Government will not supply them.

Q6. Must an applicant submit a proposal applying for all of the items in the attachments? For example must an applicant submit a proposal for sterile products and peptides and oligos? Or is it possible to submit a proposal for just some of the Technical Areas?

A6. It is not necessary to bid on all three technical areas. It is entirely acceptable to propose on only one technical area, and that does not put an offeror at a disadvantage. Our expectation is that many vendors specialize in only one or two areas at the most. Each technical area proposed upon is scored on its own merits. We expect to make multiple awards within each technical area so that the Government has a roster of qualified vendors to serve the needs of each technical area. See Attachment 7-Additional Technical Proposal Instructions_Template_5.26.23_FINAL_, and Attachment 12- Additional_Business_Proposal_Instructions_Template_5.11.23_MC for additional guidance.

Context of Q7: Please excuse this second email on one topic. I just realized that question of Reference standard occurs in all Technical Areas and that the SOW requests that the contractor perform stability studies on the Reference Standard as well as the Drug Product.

Q7. Vendor can perform stability studies on Reference standard material, but we cannot manufacture Reference Standard material via chemical synthesis. Would the inability to manufacture reference standard constitute a disqualifying deficiency?

A7. Offerors will not be required to manufacture Reference Standard (RS) material in support of this contract. Please note that the Statement of Work has been revised [SEE REVISED_SOW (7.10.23)_clean] to clarify the

Q8. In Attachment 3 Statement of Work; Section IV. Technical Requirements; Technical Area 1, item i says:

“Manufacture Reference Standard (RS) material for DP under cGMP, of sufficient quality and in quantities to support IND-enabling and clinical studies, typically 0.5 to 20 kg.”

Is it intended that the contractor should manufacture via chemical synthesis and characterize analytically batches of drug substance to be used as Reference Standard throughout the development and stability testing process for the Drug Product? Typically, Reference standard material is supplied by the Drug Substance Manufacturer.

A8. Offerors will not be required to manufacture Reference Standard (RS) material in support of this contract. Please note that the Statement of Work has been revised [See REVISED_SOW (7.10.23)_clean]

Q9. We have the following question as we prepare our response:

On the instructions for the Business Proposal, Subsection 3C under “Total Compensation Plan”. Our company is a private, for-profit organization and does not typically share salary information of our employees. Does this section still apply to a commercial company?

A9. Yes, this section applies to commercial companies.

Q10. In order to be able to submit our confidential pricing and methods for the package, we need to have an NDA in place.

A10. The National Center for Advancing Translational Sciences (NCATS) does not sign Non-Disclosure Agreements with vendors. Safeguarding proposal information and source selection information is safeguarded by FAR 3.104, Procurement integrity.

Q11. I’m curious if a proposal to develop and produce this key material (Limulus clotting Factor C) via fermentation fits within the scope of the program you are running?

A11. The scope of the RFP is to make clinical candidates for NCATS projects. The proposed reagent manufacturing by the offeror doesn’t meet the requirements of this RFP.

Q12. On the sam.gov website they say “The contractor shall provide support for a broad range of preclinical services….”

Some of these areas we have a great deal of experience and some of areas mentioned we don’t have experience with. Does the contractor have to provide all these services or is a comprehensive subset sufficient. For example, specializing in small molecule formation sufficient. Is there a minimal set of capabilities need to be awarded the contract?

A12. It is not necessary to bid on all three technical areas. It is entirely acceptable to propose on only one technical area, and that does not put an offeror at a disadvantage. Our expectation is that many vendors specialize in only one or two areas at the most. Each technical area proposed upon is scored on its own merits. We expect to make multiple awards within each technical area so that the Government has a roster of qualified vendors to serve the needs of each technical area. See Attachment 7-Additional Technical Proposal Instructions_Template_5.26.23_FINAL_, and Attachment 12- Additional_Business_Proposal_Instructions_Template_5.11.23_MC for additional guidance.

Q13. Do I need to complete the Excel spreadsheet?

A13. Yes, it is critical to complete Attachment 15_ Breakdown_of_Proposed_Estimated_Costs(plusfee)(5.19.23) for cost evaluation purposes.