Amendment_2.pdf

BAA No.: NIAID-DAIT-NIHAI201700100 Page 1 of 5 Amendment #2

Amendment No. 2

Broad Agency Announcement (BAA) No.: NIAID-DAIT-NIHAI201700100 “Vaccine Adjuvant Discovery Program”

Amendment Number: Two (2)

Amendment Issue Date: April 12, 2018

Response Date: July 31, 2018 by 3:00 PM, EST

Issued By: George Ralis

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3C19, MSC 9821 Rockville, Maryland 20852

Point of Contact: PRIMARY ralisg@niaid.nih.gov George Ralis, Contracting Officer Phone: 240-669-5146

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals is still July 31, 2018 by 3:00 PM, EST.

Offerors must acknowledge receipt of this amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

PURPOSE: This amendment is to provide responses to questions which may be useful to all potential offerors.

NOTE: As part of this Amendment, we request that all questions pertaining to the BAA be submitted to the Government no later than June 15, 2018, 3:00pm EST.

QUESTION/ISSUE 1:

Are European SME’s eligible as a lead applicant for the Vaccine Adjuvant Discovery Program (Solicitation Number: NIAID-DAIT-NIHAI201700100)?

mailto:ralisg@niaid.nih.gov

BAA No.: NIAID-DAIT-NIHAI201700100 Page 2 of 5

RESPONSE:

Yes, proposals from any size offerors, whether non-U.S. or U.S.-based offerors with foreign subcontractors, are allowed.

QUESTION/ISSUE 2:

At what stage does the company need to have the vaccine development for an applications under study area 2 (Identification of the mechanism of action of lead adjuvant candidates) and study area 4 (Preclinical testing of adjuvant:vaccine in vivo using one or more appropriate animal model systems to determine the immunogenicity and safety of lead adjuvant candidates formulated with a vaccine)?

RESPONSE:

Please note that proposals must address ALL four study areas. The BAA solicits proposals that identify novel immunostimulatory compounds (high-throughput screening of compound libraries in SA1), optimizes them through e.g., medicinal chemistry and formulation (SA2), determine the mechanism of action of lead compounds (SA3) and tests lead compounds with licensed or experimental vaccines in preclinical studies (SA4). NIAID supports the further development of previously identified adjuvants through different funding mechanisms.

QUESTION/ISSUE 3:

Can we propose two-year or three-year-base period?

RESPONSE:

Yes, offerors may propose different base and option years as long as the total period of performance is within 5 years. Please keep in mind that all study areas in Attachment 5 of the solicitation must be addressed.

QUESTION/ISSUE 4:

I am hoping to find out if there is an incumbent contractor currently performing these services or if this is a new requirement. If there is an incumbent, could you please provide the contract number?

RESPONSE:

The information is written in 'ATTACHMENT 4: BACKGROUND and INTRODUCTION' of the solicitation.

QUESTION/ISSUE 5:

I noticed that there was a deadline for Attachment 2, ‘Proposal Intent Response Sheet’ on March

14. DO you still want us to submit even though we are after the date?

RESPONSE:

The ‘Proposal Intent Response Sheet’ is optional. The sheet provides us with a quick gauge of

BAA No.: NIAID-DAIT-NIHAI201700100 Page 3 of 5 who’s intending to submit proposals. But the important date, for any and all potential offerors, is the response date of proposals. Currently, that date is July 31, 2018 by 3pm EST. If that date gets changed for any reason, an announcement will be posted on Fedbizopps.

QUESTION/ISSUE 6:

How critical is it to focus on a new adjuvant for an existing vaccine versus a new adjuvant approach for a vaccine antigen (that might be part in an existing vaccine or a new vaccine antigen that is not part of a current existing vaccine)?

RESPONSE:

The objective of the Adjuvant Discovery Program is to identify novel compounds with immunostimulatory activity, which can be further developed as vaccine adjuvants. The in vivo evaluation of novel lead adjuvant candidates (Study Area 4) requires the use of (one or more) vaccines. The NIAID does not specify which vaccine should be used to test the efficacy of lead compounds in animal models: Vaccines used for this purpose include, but are not limited to, recombinant proteins, subunit vaccines, and nucleic acid-based vaccines and may be either licensed or experimental vaccines. NIAID encourages investigators to consider how novel adjuvants can address the limitations of current vaccines, such as the induction of Th1 or Th17-responses, adjuvants that can safely and effectively be used in special populations, or adjuvants that can be delivered by different vaccination routes.

QUESTION/ISSUE 7:

If the focus is on an existing vaccine, is it important to have a relationship with the company producing the vaccine antigen?

RESPONSE:

Please see Attachment 7/Section 7/Paragraph 9: Document the availability of reagents that are not commercially available, such as the vaccine(s) used for in vivo studies.

QUESTION/ISSUE 8:

[Related to the question immediately above], how important is it to have a company as part of the project?

RESPONSE:

The involvement of a company in a proposed project is not a requirement and most of the current Adjuvant Discovery contractors are academic institutions. It is the offeror’s responsibility to choose the most appropriate subcontractors, or fee-for service providers for the proposed project.

QUESTION/ISSUE 9:

If a new vaccine would be considered is there a specific priority on an existing vaccine target?

BAA No.: NIAID-DAIT-NIHAI201700100 Page 4 of 5

RESPONSE:

Since the main objective of the program is the discovery of novel adjuvants, the NIAID does not list priority pathogens. Instead, offerors are encouraged to search for adjuvants capable of overcoming limitations of current vaccines as described above and in Attachment 4/paragraph 4.

Offerors should use vaccines for which they have the tools and assays necessary to comprehensively evaluate the lead adjuvants’ activity.

QUESTION/ISSUE 10:

[Related to the question immediately above], would an influenza vaccine be within the priority area.

RESPONSE:

Using an influenza vaccine model to test novel adjuvants discovered in the context of an Adjuvant Discovery contract award would be appropriate, assuming the offeror has the necessary reagents and assays needed to evaluate the adjuvanticity of newly identified compounds.

QUESTION/ISSUE 11:

Is the Lobbying Disclosure required at time of proposal?

RESPONSE:

Yes. It’s required at time of proposal submission.

QUESTION/ISSUE 12:

Clarify the ‘fixed fee’ that is stated in Article. B.2.b.: The fixed fee for the Base Period of this contract is $[TBD]. The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer.

RESPONSE:

If an offeror proposes a fixed-fee in its pricing proposal, they will need to include the percentage of their fixed fee. If an offeror does not intend to propose a fixed-fee, then this would not be applicable to the offerors proposal.

QUESTION/ISSUE 13:

Can the NIAID further describe what you are looking for regarding the ‘index’ when you discuss this statement in c. Business Proposal Instructions, 3. Certified Cost or Pricing Data. 1. General Instructions. B.: In submitting your proposal, you must include an index, appropriately referenced, of all the certified cost or pricing data and information accompanying or identified in the proposal. In addition, you must annotate any future additions and/or revisions, up to the date of agreement on price, or an earlier date agreed upon by the parties, on a supplemental index.

BAA No.: NIAID-DAIT-NIHAI201700100 Page 5 of 5

RESPONSE:

The “index” basically is a table-of-contents for the Certified Cost or Pricing Data.

QUESTION/ISSUE 14:

Shall July 15, 2019 be proposed as the start date for budgeting purposes in the proposal?

RESPONSE:

Using the July 15, 2019 date is fine.

QUESTION/ISSUE 15:

We have developed a nanoparticle as a self-adjuvanting platform technology. Would further work with this type of adjuvant be responsive to NIAID’s adjuvant discovery solicitation?

RESPONSE:

Solicitation NIAID-DAIT-NIHAI201700100 only supports the discovery of novel vaccine adjuvant candidates, but not work on previously identified adjuvants (see Attachment 5, Research and Technical Objectives). NIAID promotes the further development of previously discovered vaccine adjuvants through other programs, including the SBIR mechanism. Please see the following new council concept which was approved by the NIAID advisory council in January 2018: Adjuvant Development for Vaccines and for Autoimmune and Allergic Diseases -https://www.niaid.nih.gov/grants-contracts/january-2018-dait-council-approved-concepts#06

QUESTION/ISSUE 16:

We are synthesizing various polymers that self-assemble into nanoparticles and subsequently test them with vaccines. We have also identified a potential novel molecular mechanism through which these particles mediate adjuvanticity. Would the synthesis, screening and optimization of such particles be suitable for solicitation NIAID-DAIT-NIHAI201700100?

RESPONSE:

Based on the brief description of the proposed project, it appears that the materials in question would not only act as delivery systems, but also meet the definition of an adjuvant as specified in the BAA. The solicitation requires the offeror to screen compound libraries in Study Area 1, but does not place any restrictions on the source of the library. Therefore, creating large compound libraries based on certain core structures is acceptable. While the BAA requires “high-throughput screening” of compound libraries, it does not specify a minimal size of such libraries. Since the nature of the library (random, vs. pre-screened, vs. selected) significantly affects the predicted hit rate, it is the offeror’s responsibility to determine a reasonable size for the library that will be screened.

END OF AMENDMENT NO. 2, NIAID-DAIT-NIHAI201700100

https://www.niaid.nih.gov/grants-contracts/january-2018-dait-council-approved-concepts#06