BAA-18-100-SOL-00003_Special Instructions AOI 3_4_Inquiries_Responses_20210603.pdf

Inquiries for BARDA BAA-18-100-SOL-00003 Amendment #25, Special Instructions for Area of Interest #3.4 Antibacterial Accelerator were collected from May 12, 2021 through May 19, 2021. Responses to inquiries are provided below.

1. INQUIRY: Can my company submit a proposal to BARDA for an individual product under the Special

Instructions for Area of Interest #3.4 Antibacterial Accelerator?

RESPONSE: The intention of these Special Instructions is to solicit proposals from Offerors who could serve as the antibacterial accelerator entity. The accelerator will be responsible for creating systems and processes to administer and manage a portfolio of investments to individual companies for their antibacterial product candidates through sub-awards. These Special Instructions do not seek to identify those potential candidates that the accelerator’s portfolio will contain. Instead, they aim to identify an Offeror that can serve as the entity that provides a combination of non-dilutive funding, technical support, business development processes, infrastructure, and subject matter expertise to support companies through the early stages of their product development.

2. INQUIRY: How can my company apply for a sub-award for our product to be part of the antibacterial accelerator’s portfolio?

RESPONSE: The antibacterial accelerator will be responsible for managing the process for companies to apply for accelerator sub-award funding. When available, calls for funding opportunities will be publicly announced by the antibacterial accelerator. BARDA will amplify these announcements through its public communication channels.

3. INQUIRY: What types of products will the antibacterial accelerator’s portfolio contain?

RESPONSE: The accelerator’s enterprise will support antibacterial candidates that treat, prevent, or detect bacterial infections. The accelerator’s portfolio will prioritize new classes of antibiotics, products for novel targets or those with novel mechanisms of action, and non-traditional approaches.

Through sub-awards, antibacterial candidates may enter the portfolio as early as the hit-to-lead stage of development; devices may enter the portfolio as early as the feasibility stage of development. The accelerator will advance/accelerate the development of these candidates through Investigational New Drug (IND) filing and Phase 1 clinical trials (single ascending dose/multiple ascending dose), such that they are poised for further clinical development outside the accelerator. The accelerator may elect to provide technical and financial support to companies to support additional early clinical studies or Phase 2 clinical trials if approved by a Joint Oversight Committee.

4. INQUIRY: What types of sub-awards are anticipated as outlined in section 2.4. Sub-Award

Application Process?

RESPONSE: The antibacterial accelerator will be responsible for managing a portfolio of investments supporting various companies’ antibacterial candidates. The accelerator will issue non-dilutive funding sub-awards directly to companies for research and development activities for their candidates. Sub-awards can fund activities in a number of areas, including but not limited to:

nonclinical development; pharmacokinetics/pharmacodynamics; toxicology; clinical planning; and chemistry, manufacturing, and controls.

The accelerator will create a process for soliciting sub-award applications. Individual candidates will be selected by the Joint Oversight Committee for inclusion in the portfolio based on the strategic goals and needs identified by the accelerator’s strategy. After candidates are approved for sub-award funding, the accelerator will be responsible for all aspects of sub-award issuance and management.

5. INQUIRY: How can my company identify opportunities for partnership with BARDA that are outside of the scope of these Special Instructions for Area of Interest #3.4?

RESPONSE: Outside of the Special Instructions for Area of Interest #3.4, BARDA BAA-18-100-SOL- 00003 solicits proposals that focus on research and development in other areas of interest. Please note that due to the COVID-19 response, any white papers or full proposal submissions, other than those that are in support of COVID-19, will be put into a queue. Once the response to COVID-19 has subsided, we will resume normal review of submissions for other research areas of interest.

For additional information about BARDA’s Division of Chemical, Biological, Radiological, and Nuclear Programs, including funding opportunities based on product stage, please visit:

https://www.medicalcountermeasures.gov/barda/cbrn/

We also encourage companies to participate in BARDA Industry Day, our annual stakeholder conference to learn about U.S. Government medical countermeasure priorities and interact with the BARDA teams. For details on the 2021 BARDA Industry Day, please visit:

https://www.medicalcountermeasures.gov/newsroom/2021/bid2021save/.

Companies developing early-stage antibacterial candidates may also wish to explore partnership opportunities with the National Institute of Allergy and Infectious Diseases: https://www.niaid.nih.gov/.

6. INQUIRY: Can you please clarify whether this BAA announcement is to continue/extend the work being conducted by Boston University CARB-X or if this a new, separate opportunity?

RESPONSE: Boston University (BU) was the awardee for the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) program. This is a new, separate opportunity for an Antibacterial Accelerator to build off of the existing CARB-X program.

7. INQUIRY: What are the OT requirements that are referenced in Special Instructions, Section 4.4 (page 11)? Are the OT requirements different than the list of mandatory evaluation requirements listed in Section 4.3 (pages 9-10) of the Special Instructions?

RESPONSE: The performance and capability requirements for the Antibacterial Accelerator are discussed in the Key Functions outlined in Section 2 and the Mandatory Criteria in Section 4 of the Special Instructions. The Evaluation Ratings defined in Section 4.4 of the Special Instructions will be used to evaluate the capabilities of the Offeror’s proposed Antibacterial Accelerator to perform the work described in Sections 1 through 3 of the Special Instructions. Evaluation Ratings will be applied to proposals based on the information provided that demonstrates the Offeror’s ability to meet the Evaluation Criteria stated in Section 4.3.2.

8. INQUIRY: Will BARDA share the OT agreement (template) with anticipated terms and conditions and cost provisions in advance of an award?

RESPONSE: Given the flexible nature of an OT agreement, there is no template to be shared. A draft OT agreement, based on the selected Offeror’s proposal, will be shared with the selected Offeror to initiate agreement negotiations.

9. INQUIRY: Can BARDA provide further clarification on the concurrent Base/Option periods and any specificity regarding funding availability by current/future fiscal years, Section 3.1 (page 7)?

RESPONSE: Option Periods may be exercised under the OT, based on the availability of funds. Base and Option Periods may perform concurrently. Typically one Option Period is exercised per fiscal year; however, if funding allows, multiple Option Periods may be exercised in the same fiscal year. It https://www.medicalcountermeasures.gov/barda/cbrn/ https://www.medicalcountermeasures.gov/newsroom/2021/bid2021save/ https://www.niaid.nih.gov/ is anticipated that the OT will have a total targeted ceiling of up to $175 million exclusive of cost sharing, $20 million of which is anticipated in the Base Period (based on the availability of funds).

10. INQUIRY: Will BARDA be able to issue an Option as early as the effective start date of the award, if requested? If not, what is the time limit for any Option requested?

RESPONSE: The timing of Option Periods will be based on the availability of funds and may be discussed during OT agreement negotiations. The Government anticipates an OT award start date between September and December 2021.

11. INQUIRY: Can BARDA confirm whether the anticipated start date of a successful award could be as early as September 1, 2021, or what would be the earliest anticipated date?

RESPONSE: The timing of award will be determined during OT agreement negotiations. Offerors may propose an agreement award date. The Government anticipates an OT award start date between September and December 2021.

12. INQUIRY: Will there be an opportunity for written approval of pre-award spending?

RESPONSE: There will not be an opportunity for written approval of pre-award spending.

13. INQUIRY: Volume I – Technical Proposal Attachments – Are resumes which are to be included in addition to Biosketches included in the 70 page limit?

RESPONSE: The 70 page limit of Volume I includes all Technical Proposal Attachments.

14. INQUIRY: Volume II – Cost Proposal and Cost Proposal Attachments (pg. 81) – Are there page limits for the Cost Proposal portion of the application?

RESPONSE: There are no page limits for Volume II – Cost Proposal and Cost Proposal Attachments.

15. INQUIRY: Volume II – Cost Proposal (page 83) – Are there any limits on individual salary levels for this agreement?

RESPONSE: Pursuant to current and applicable prior Department of Health and Human Services (HHS) appropriations acts, awards made under the BAA will be subject to a salary rate limitation on funds used to pay the direct salary of individuals. Please refer to page 83 of BAA-18-100-SOL-00003 for additional information.

16. INQUIRY: Volume II – Cost Proposal (page 85) – What is required for Lobbying Activities for an OT agreement?

RESPONSE: Disclosure of all lobbying activities is required. Proposals should include form SF-LLL:

Disclosure of Lobbying Activities.

17. INQUIRY: Volume II – Cost Proposal (page 85) – Is a Subcontracting Plan required during proposal stage or for award under an OT agreement?

RESPONSE: A Subcontracting Plan is not required.

18. INQUIRY: Volume II – Cost Proposal (page 86) – SF 424 forms are required for grants; is there any other form required for OT submission?

RESPONSE: Form SF 424 is not required.

19. INQUIRY: Full Proposal Submission (page 89) – In addition to the electronic submission as detailed in the Special Instructions, 4.8 Contact Information, page 12, will BARDA also require a mailed paper copy?

RESPONSE: BARDA is only accepting electronic submissions of proposals. Paper copy submissions of proposals will not be accepted. See revised Special Instructions document included in Amendment #26 to this BAA.

20. INQUIRY: Attachment 8 (page 119) – Is the Certificate of Current Cost or Pricing Data required for an

OT?

RESPONSE: The Certificate of Current Cost or Pricing Data is required.