Amendment 1 - Vaccine Patch QA.pdf

23-BARDA-PRIZE-VP AMENDMENT 001

QUESTIONS AND ANSWERS

1. We understand that BARDA is focused on the health security of the American people. On the other hand our understanding is that the prize should be designed to identify and entice patch innovators internationally. Have we understood this correctly? Yes, while FDA licensure of these potential vaccines is a key goal, we do wish to entice international development efforts.

2. Will the design of the challenge consider affordability in patch/vaccine design and access in the global south or is this out of scope? While part of the evaluation criteria, development objectives would likely align with increasing access the technology. This is not specifically called out given the stage of development.

3. The call paper makes clear that disbursement of prize funds to competitors would be done by the prize provider. While our company has experience with receiving and disbursing funds in US dollars and internationally, would BARDA require us to secure a US-based partner to do this disbursement? BARDA does not specifically require this, although it is the onus of the prospective Respondent to ensure prize payments could be facilitated in accordance with law to all eligible parties.

4. Our understanding of the solicitation is that we should explain how we will design the prize but that in the proposal itself we should not propose a prize design, have we understood this correctly? Yes, that is correct.

5. In the solicitation it says: “Provide testing service for participants to validate technologies, as appropriate based on the design of the prize competition. The Vaccine Patch Prize is not currently anticipated to require any testing services.” Does this mean that we should not budget for any testing or validation within our proposal? That is correct. Because the Vaccine Patch Prize Competition is not anticipated to require testing services, the proposed price to administer this challenge does not need to incorporate costs for these services. However, the technical approach should address what, if any, testing services the respondent is able to provide or facilitate for the validation of technologies under potential future competitions under this effort.

6. Does BARDA have any guidelines on developing program budgets that we should adhere to?

For example, the expected ratio of grants and prize purse to delivery costs (including non-financial support)? There are no specific restrictions on ratio of payment deliveries to administrative/delivery cost. Prospective respondents should plan to propose their most competitive pricing in what we expect to be a very competitive environment.

7. Lines: 39-41: The RFP asks the prize vendor to promote the prize “to increase additional public/private investment and interest.” Please describe any specific targets BARDA envisions with respect to co-funding as part of the program. There are no specific targets at the moment. Many other sponsoring organizations in the US and around the world with aligned goals may be in a position to partner on the Vaccine Patch Prize competition with additional investments and other contributions, and BARDA envisions exploring those opportunities

8. Lines 43-44: The RFP notes that the prize vendor shall “Coordinate and administer the prize competition(s) with BARDA and participants, including awarding of cash prizes and other rewards.” Please confirm if BARDA expects the prize vendor to directly disburse the prize funds. Yes, Line 241-243 of the solicitation states that BARDA intends to include the $50 million prize purse for the Vaccine Patch Prize as an obligation on this Agreement, to be paid to successful competitors upon authorization from BARDA.

9. Line 55: Does BARDA anticipate increasing the prize pool? The estimated prize for the

Vaccine Patch challenge is $50 million. Per Lines 169-171 of the solicitation, the overall ceiling for this effort, inclusive of all prize funds for any competitions issued under this award, is $100 million. BARDA does not anticipate increasing the prize pool for the Vaccine Patch Prize competition beyond $50 million.

10. Line 55: Describe any follow-on funding mechanisms, beyond the prize pool, that BARDA may deploy to achieve the end goal. No follow-on funding mechanisms can be assumed at this time.

11. Line 56: Noting the competition is intended to be international, must teams include a US– domiciled entity? Not necessarily. The solicitation is open to all prospective respondents outside of the list of embargoed and sanctioned countries, as defined by U.S. Departments of Treasury and Commerce.

12. Line 56: Are awards allowable to primary entrants that are not US-domiciled? The solicitation is open to all prospective respondents outside of the list of embargoed and sanctioned countries, as defined by U.S. Departments of Treasury and Commerce.

13. Line 56: Are there limitations on the disbursement of funds to particular geographies (beyond the Foreign-Owned Interest restrictions.) The successful respondent will need to adhere to the USG prohibited sources list as referenced in the solicitation. BARDA may provide advisement prior to the disbursement of funds.

14. Lines 81-82: Will current or past recipients of BARDA Nextgen funding be eligible to participate in the Vaccine Patch Prize? The source of funding received, including funding related to Project NextGen, should not impact an entity’s eligibility to respond.

15. Lines 100-104: The call for submissions notes that the prize vendors’ responsibilities include hosting two in-person meetings. Should the budget also reflect the direct costs for these two meetings (e.g., space rental, catering, audio/video, photography, etc.)? Yes, respondents should propose all necessary costs associated with organizing and hosting the in-person public meetings.

16. Lines 100-104: For the second in-person meeting, does the “awardee location” refer to the location of the successful respondent or the location of the first-to-finish participant? The “awardee location” refers to the location of the successful respondent.

17. Lines 110-111. Please expand upon the evaluation and selection responsibilities of the prize vendor. Task 1 will involve the successful respondent proposing submission instructions and evaluation criteria, and Task 3 will involve the successful respondent coordinating the administration of the prize competition to include a helping develop a defined process for evaluation and selection. The evaluation and selection will be conducted by the appointed judges, and all final decisions will be made by BARDA.

18. Lines 110-111. Who will identify and select the review or judging panel(s)? BARDA will establish the panel to evaluate competition participants.

19. Lines 110-111. Does BARDA anticipate that reviewers or judges may include non-federal employees? Yes.

20. Lines 110-111. Who will onboard the review or judging panel(s)? It is expected that the vendor will be responsible for onboarding, training, and managing the reviewers or judging panel(s).

21. Lines 112-113: Please expand upon the nature and depth of training and tools the prize vendor will need to provide to “Provide access, relevant training and hosting capabilities for tools to support the prize competition.” Respondents are expected to propose sufficient training and tools to successfully complete the tasks as described in this solicitation.

22. Lines 117: Please elaborate on the need to provide testing services if “The Vaccine Patch Prize is not currently anticipated to require any testing services.” This is needed for potential future prizes. As stated, the current Vaccine Patch Prize competition is intended to be for $50 million, the ceiling on the Agreement is anticipated to be $100 million.

23. Lines 120-121: the RFP states “Provide usability or user input as needed on a case-by-case basis, including for the Vaccine Patch Prize.” What does BARDA envision the usability or user input to consist of for the Vaccine Patch Prize? BARDA anticipates that user input, either through surveys, focus groups, and/or real world studies, will be incorporated in both the design phase of the competition and as part of the rules and requirements of the competition itself for participants.

24. Line 124: Can the required disclosures be in an Appendix, with no page limit? Yes.

25. Line 145: The RFP asks for a proposed OCI mitigation plan for all USG program(s) that any member of the proposed team is currently working on or have provided professional consulting services for. Does BARDA expect a mitigation plan for each USG program, or can the respondent provide (1) blanket mitigation plan? One mitigation plan is acceptable provided that it adequately addresses the solicitation requirements for all potential conflicts of interest.

26. Lines 153-160: Does the 212k limit apply to programs under this solicitation only, or does it apply to all programs funded by HHS (in the event Awardee has other contracts with HHS)?

Per the Consolidated Appropriations Act, 2023, designated HHS funds may not be used to pay a direct salary in excess of the Executive Level II of the Federal Executive pay scale ($212,100 for FY2023). As interpreted, the limitation is an annual salary cap per contract.

27. Lines 162-163: The solicitation requires the respondent to “demonstrate the ability to maintain an accounting system that is capable of tracking the expenditures of USG funds.” Is an attestation in an Appendix sufficient? An attestation in an appendix is sufficient for proposal submission. BARDA reserves the right to request additional supporting documentation during negotiations as necessary.

28. Lines 167-169: By what date does BARDA anticipate an award will be made? BARDA anticipates making an award from this solicitation by September 30, 2023.

29. Lines 167-169: The 5-year period of performance noted in the RFP includes a design phase, 3-year competition, and post-award services. Please expand upon the fidelity and expected delivery timeline for post-award services. The estimated period of performance of 5 years is intended to encompass the design phase, the 3-year competition period, and the post-award services that may be required, however revisions to length of the initial phase should not impact price. This is an estimate only, and may be subject to change based on the design of the competition. It is also subject to change based on any additional competitions that may be incorporated under this effort.

30. Lines 195-198: Please specify the minimum font size for proposal narrative copy and the minimum font size for proposal tables. Respondents may use their desired font and font size provided that proposals are clearly legible. Illegible proposals will not be reviewed.

31. Lines 195-198: Please indicate if there is a preferred font for the narrative. Respondents may use their desired font and font size provided that proposals are clearly legible. Illegible proposals will not be reviewed.

32. If awarded, will the awardee’s role will be classified as directly “supporting and advising BARDA funding decisions”. Please clarify what is meant by and/or what the difference is between: a) “supporting” and b) “advising” funding decisions as it applies to this solicitation.

Not specifically. The awardee’s role would be classified as providing prize services consistent with the final terms negotiated in the Agreement.

33. Please clarify how this Prize OTA fits in with other outstanding BARDA programs and initiatives (e.g. BioMac, Rapid Response, Project NextGen), and whether this Prize OTA is a wholly independent vehicle or a component of another larger program. This prize requirement OT is an independent vehicle. The first prize competition, as described, is intended to be part of the overall Project NextGen program.

34. Is there a known budget or not-to-exceed price for labor and services for this effort?

Respondents are encouraged to submit their most competitive pricing for the tasks as detailed in the solicitation as we expect to receive a robust response.

35. For developing the technical approach and pricing information, should vendors assume supporting only the vaccine patch prize competition? Because the Vaccine Patch Prize competition is not anticipated to require testing services, the proposed price to administer this challenge does not need to incorporate costs for these services. However, the technical approach should address what, if any, testing services the respondent is able to provide or facilitate for the validation of technologies under potential future competitions under this effort.

36. Is this a new or follow-on requirement? If follow-on, may BARDA please provide the incumbent award information? This is a new requirement.

37. Does BARDA wish for competitions under this vehicle to be hosted on an existing challenge platform or is a custom BARDA competition site desired? The successful respondent will build and manage a website with a unique URL that will serve as the central public source for all prize information.

38. Are there any specific desired key personnel roles/labor categories? No.

39. Should pricing include the initial $50MM prize purse? If so, are prize funds to be considered an Other Direct Cost (ODC)? Line 241-243 of the solicitation states that BARDA intends to include the $50 million prize purse for the Vaccine Patch Prize as an obligation on this Agreement, to be paid to successful competitors upon authorization from BARDA. The proposed price should be reflective of all the activities included in the firm fixed price for tasks outlined under Section II of the solicitation.

40. If additional prize competitions are being considered under this vehicle, will all additional competitions be focused on medical device development or will there also be requirements for data science and digital solutions in other prize challenges? BARDA has not yet made a decision about future prize competitions under this vehicle.

41. Are there any existing eligibility requirements and/or constraints to consider (ie. COMPETES, Ph.D required to participate, etc.) for competition participants? This vehicle and the prize competitions administered as part of it will not be guided by the COMPETES Act.

Eligibility requirements for participants will be developed as part of Task 1 in coordination with BARDA.

42. Line 191: We are registered on SAM.gov, and have done prize competitions that meet the eligibility requirements of this RFP. Are we required to update SAM.gov with NAICS 541714 in order to be eligible? No, not at this time.

43. Line 56: Does the regulatory approval milestone, described in section III., refer to only U.S.

regulatory approval? If not, what countries’ approvals are allowable? This refers to US regulatory approval.

44. Line 56: Can the government please specify which regulatory approvals the solutions must seek in solving the Vaccine Path prize competition? US regulatory approvals (FDA).

45. Line 51: Can you please clarify the not to exceed budget for the Vaccine Patch Prize - the anticipated prize amount as well as the budget for services to administer the challenge?

Respondents are encouraged to submit their most competitive pricing for the tasks as detailed in the solicitation. The anticipated Vaccine Patch prize funding, not inclusive of services by the successful respondent, is anticipated to be $50 million.

46. Are there limitations on a vendor submitting as a prime as well as being a subcontractor on other proposals? BARDA does not have limitations of this nature. Any conflicts arising from these types of proposed teaming arrangements will be the responsibility of the respondents.

47. Is there a desired launch date for the Vaccine Patch challenge? BARDA would like to launch the Vaccine Patch challenge by the end of CY2023.

48. Line 64: Can the government please expand on the definition of “first to finish challenge” and it’s implications on challenge design and judging? “First to finish” refers to a desire to award to the participant who reached the desired milestones first. This is not necessarily a rigid requirement, and BARDA will work with the successful respondent to determine the most appropriate prize design as part of Task 1.

49. Line 120: Can the government expand on the requirement for “usability or user input”? At what part of the challenge is this input required? BARDA anticipates that user input, either through surveys, focus groups, and/or real world studies, will be incorporated in both the design phase of the competition and as part of the rules and requirements of the competition itself for participants.

50. Line 75: Can the government describe the subject matter experts to which it has access, with regard to experience and how it relates to the competition(s)? BARDA has deep technical knowledge on vaccine development, formulation, manufacturing, and clinical trials, and deep knowledge and landscape of the patch-based delivery industry, given BARDA’s prior investments and R&D partnerships in the space.

51. What TRL is BARDA interested in? Is the goal of the challenge to identify new providers/manufacturers in the space, or find a technology that can be taken to market quickly?

BARDA’s primary goal is to commercialize combination vaccine patch technologies that currently in development. It is not anticipated that BARDA will identify, as part of this challenge, any new technologies, although new partnerships between patch developers and vaccine manufacturers may be formed as part of this challenge.

52. Will BARDA be providing judges for the various contest milestones and/or final award? Is this a capacity that the government’s subject matter experts can fulfill? BARDA anticipates contributing to the review and judging, along with non-federal participants. BARDA will make the final decision on prize competition winners at all stages.

53. What approval and review time does the government expect to require (to announce the challenge, select and approve winners, etc.)? BARDA anticipates announcing and officially launching the prize by the end of 2023, with timelines appropriate to stage and scope of the competition.

54. Line 331: Section IX Award Decision does not state a decision timeline or date. When are you estimating a decision announcement will be made by? BARDA anticipates making an award from this solicitation by September 30, 2023.

55. Will the government advise on OCI scenarios before proposal submission? How should we engage with the government if we have a potential OCI to review prior to proposal submission?

If you believe that you have an OCI that cannot be mitigated, you may contact BARDA at VaccinePatch@hhs.gov. BARDA may provide preliminary advisement but will not make a formal determination.

56. Is the contractor expected to establish the legal agreements for the participants or will those be provided by the government? Per Lines 88-91 of the solicitation, the successful respondent shall propose a plan for eligibility criteria, submission instructions, evaluation criteria, terms/conditions, and prize competition schedule in conjunction with BARDA and BARDA stakeholders, including management of conflicts of interest for participants and stakeholders, and intellectual property rights consistent with industry best practices.

57. Line 117: Can you elaborate on the potential requirement for providing testing services to participants? What kind of testing is expected? Testing services refers to any third party testing that may be required to verify the performance of a medical product or other solution, either against an objective metric or in head-to-head competitions. This service is not expected to be utilized as part of the Vaccine Patch Prize competition but may be considered for future prizes under this OT.

58. Can partnerships/subcontracts be established after the July 14th NOI deadline/submission?

Yes.

59. Line 15: Can the Government define 'complement' traditional contract-based… The OT vehicle is intended to supplement, rather than replace, BARDA’s traditional approaches to partnering for advancing research & development.

60. Line 57: Is the current challenge specifically for a combination vaccine product”? The Vaccine

Patch Prize competition will be focused on the commercialization of a vaccine patch combination product.

61. Line 64: How rigid is the 'first-to-finish'? This is not necessarily a rigid requirement, and BARDA will work with the vendor to determine the most appropriate prize design as part of Task 1.

62. Line 66-67: Collaborations. Will the winners be required to have established agreements/partnership? This statement is intended to provide respondents to this solicitation with a general idea of the types of entities that will be participating in the competition. The rules and eligibility requirements for the competitions will be developed during the performance of this OT.

63. Line 92: Are there any limitations to the tools and techniques used during the promotion phase?

Not necessarily, although the goal is to target promotion to attract a sufficiently high quality of participants, potential collaborating sponsors, and potential follow-on partners.

64. Line 103-104: For the in-person meetings, is there a proposed scope/size for the winner announcement / demonstrations? BARDA will work with the vendor to design the most appropriate scale and scope of in-person meetings. BARDA anticipates the teaming meeting to be sufficiently large to attract leaders in both COVID-19 vaccine development and patch device companies, as well as key stakeholders such as investors, private and public, users, clinicians, and relevant federal agencies.

65. Line 112-113: How would BARDA like to see options for training, support and SME guidance to be provided to participating teams? BARDA expects the successful respondent to design and provide guidance to participating teams, based on input from BARDA subject matter experts, as well as key technical experts outside government.

66. Line 117-118: Will BARDA be paying for the testing services or just providing recommended access? BARDA anticipates paying for the testing services if they’re offered as part of the competition.

67. Line 120: Will BARDA be providing IRB and other trainings/approvals for usability or user input? IRBs and any other requirements to initiate and conduct clinical trials and studies will be the responsibility of each participant.

68. Line 183: What level of diligence is required for the “Foreign-Owned Interest” requirement?

BARDA will work with the successful respondent following award as necessary to submit any required information.

69. Line 50: How does the government envision deploying additional prize challenges under this

OT? Do you anticipate another grand challenge such as the Vaccine Patch Prize? Multiple smaller challenges? BARDA has not yet determined the anticipated size and number of desired prizes, and it will be based on need and availability of funding. It is possible that no additional prizes will be deployed under this OT.

70. Is this solicitation only focused to Consortium Management Organizations to respond to? This solicitation is focused on respondents with experience in prize vendor services who meet the minimum eligibility requirements.