RFP-NIH-NICHD-OER-2020-10 Attachments.pdf

RFP-NIH-NICHD-OER-2020-10 Attachment 1

Packaging and Delivery of Proposal

1. Proposals shall be delivered in electronic format to the Contracting Officer at jeremy.white@nih.gov

2. Offerors shall provide electronic copies of the Technical Proposal and Business Proposal by 2 PM ET, July 27, 2020.

3. No hard copies are to be provided.

mailto:jeremy.white@nih.gov

Attachment 2 – SOW 6.26.2020

STATEMENT OF WORK

Title: Needs Assessment Program for the Department of Health and Human Services (HHS) / National Institutes of Health (NIH) Small Business Innovation Research (SBIR) and Small

Business Technology Transfer (STTR) Awardees

Program: National Institutes of Health (NIH) Small business Education and Entrepreneurial Development (SEED) Office

1) BACKGROUND and INTRODUCTION

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are one of the largest sources of early-stage capital for technology commercialization in the United States. These congressionally mandated programs provide support for US-owned and operated small businesses to engage in research and development that has a strong potential for commercialization. The NIH SBIR/STTR programs enable health and life science companies within the NIH mission to translate promising technologies from the laboratory to researchers, patients, and care providers. The SBIR/STTR programs provide support through two phases: Phase I establishes the technical/scientific merit and feasibility of the proposed product or service. Phase II is to continue the research and development efforts toward commercialization of the product or service.

The SBIR and STTR programs are similar in scope, but the STTR program further encourages partnership between the public and private sector by requiring a formal collaboration with a non-profit research institution.

National Defense Authorization Act for Fiscal Year 2019, passed by the 115th Congress and signed into law as Public Law 115-232, expanded the scope of support for the SBIR/STTR programs to improve the technical and business assistance (TABA) provided to Phase I and Phase II awardees.

The NIH Office of Extramural Research created Small Business Education and Entrepreneurial Development (SEED), a new business unit, to oversee, coordinate, and strengthen efforts to accelerate commercialization of innovations across all member institutes and centers within the agency. SEED will administer the NIH TABA program in coordination with liaisons from NIH Institutes and Centers. As a component of the NIH TABA program, SBIR/STTR awardees will apply for and be selected by HHS/NIH to participate in the Needs Assessment program.

Information about these awardees will be provided to the contractor selected for this effort as part of the initiation of a new work assignment.

The development of the NIH TABA program also aligns to the goal outlined in the President’s Management Agenda, to “Improve Transfer of Federally-Funded Technologies from Lab-to- Market”. The NIH TABA program, and its goal of accelerating the commercialization of research and technologies funded by the SBIR/STTR program, also supports the NIH mission of “turning discovery into health.”

2) SCOPE

The scope of this contract is to provide Needs Assessment Reports that prioritize the technical and business needs of selected companies that are developing products/services with HHS/NIH SBIR/STTR funding.

3) TECHNICAL REQUIREMENTS

Independently and not as an agent of the government, the contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the government, as needed to perform this Statement of Work (SOW).

(a) Specific Tasks to be Performed

• Provide contract management;

• Perform background research about selected HHS-supported small businesses.

• Complete Needs Assessment Reports for selected HHS-supported small businesses.

(b) Key Personnel

The Contractor shall identify and retain at least the following key personnel:

• An experienced Project Manager

• A Medical Product Regulation subject matter expert

• A Life Science Industry Market Research subject matter expert

• A Life Science Industry Business Development subject matter expert with expertise in early stage company partnering, investing and sales/marketing strategy.

Technical Category 1 – Management and Administration

1.1 Contract Management

The Contractor shall:

• Provide for the overall management, integration, and coordination of all contract activities, including the management and coordination of activities carried out under any subcontracts;

• Provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all projects carried out under this contract and effective communications with the Technical Monitor, COR and CO;

• Provide a Project Manager with responsibility for overall project management and communications, tracking, monitoring, and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors.

1.2 Meetings

Kickoff Meeting

Within 14 calendar days of award of the contract and at the start of each option year, the contractor shall participate in a one-day Contract Kickoff Meeting with the COR, CO, Technical Monitor, and other SEED personnel designated by the Technical Monitor, to be held either virtually or at the government site. The purpose of the Contract Kickoff Meeting shall be to orient the Contractor to SEED contract procedures and expectations, describe anticipated activities, and best practices. For option years, the kickoff meeting will also include lessons learned and changes anticipated from prior performance periods.

Monthly Meetings/Teleconferences

The Contractor shall meet at a minimum of monthly with the SEED COR to discuss and review active/completed assignments, quality control issues, delivery schedules, and costs/budget matters (with CO) as necessary. At a minimum, meetings shall include the Project Manager (or equivalent labor category).

1.3 Management Plan

The Contractor shall provide the Technical Monitor, CO and COR, as well as the SEED Director and HHS Small Business Program Lead, a proposed Management Plan for the conduct of the program four days in advance of the kickoff meeting.

This plan shall outline the contractor’s approach and procedures for the following areas:

• Project Management

• Project Organization

• Schedule and Budget Adherence

• Reporting

• Staffing and Staff Retention

SEED will provide written comments on the proposed Management Plan within 2 weeks of the kickoff meeting.

The contractor shall provide a finalized Management Plan within 2 weeks of receipt of comments which incorporates SEED’s written feedback.

The Contractor shall:

• Maintain close communication with the SEED Technical Monitor, SEED Director, and HHS Small Business Program Lead in monitoring all technical categories;

• Supervise and coordinate project staff and consultants;

• Maintain control of the budgets for all tasks and notify the COR and CO when the budget has reached 75% of the funding limit during each period of performance;

• Assure that data on the budget and progress of all activity is tracked separately and is available in scheduled Project Management reports;

• Submit resumes for replacement of key personnel to the COR and CO for review and approval prior to assigning new leadership to technical categories;

• Deliver required Project Management and Needs Assessment Reports, plans, and other deliverables that are accurate, error-free, completed within budget, and submitted in accordance with the delivery schedule designated in each technical category;

• Assign and maintain staff with appropriate skills and experience for each technical category;

• Document in monthly status reports the number of Needs Assessment Reports completed since the last report and estimated time to complete ongoing Needs Assessment Reports;

• Organize and archive Project Management and Needs Assessment Reports in acceptable electronic formats that can be easily accessible to contract or government staff.

1.4 Satisfaction Survey

The Contractor shall:

• Conduct a Needs Assessment Program satisfaction survey of each program participant after delivery of each Needs Assessment Report. The format, questions, and analysis must be mutually agreed upon by the contractor and NIH. An example of anticipated metrics is provided in Attachment A.

• Deliver data from individual Needs Assessment Program satisfaction surveys in an Excel spreadsheet to NIH annually.

• Deliver aggregate analyses of the Needs Assessment Program satisfaction surveys to NIH annually in a format agreed upon by NIH and the contractor in the kickoff meeting.

• Within 5 business days of receipt, proactively inform NIH of any surveys that indicate dissatisfaction with the program and propose resolution measures if appropriate.

1.5 Transition Plan

Four months before the end of the contract period, the Contractor shall submit a detailed draft Transition Plan addressing orderly transfer of the program and all deliverables to a Successor or the Government. The Government will provide written feedback on the draft Plan within 1 month. The Contractor shall submit a Final Transition Plan to the Government 10 weeks before the end of the contract period.

• The Transition Plan shall address, in specific terms, the orderly transfer of the following:

o All electronic and physical files—including reference files, working files/drafts, inquiry responses and response database/data, writer’s files, graphic/desktop publishing files publications, electronic data sets, and other materials;

o Delivery of usable listings and documentation of all files to the SEED COR and CO;

o All software programs developed, purchased, or altered in the performance of the previous contract and for which contract funds were expended as well as full documentation pertaining to the programs;

o The Transition Plan items and activities shall be delivered to the CO and COR 2 weeks prior to the contract end.

Technical Category 1 – Deliverables:

• Project Management Plan outlining the Contractor’s approach and procedures to project management, project organization, schedule and budget adherence, reporting, staffing, and staff retention.

• Monthly invoices

• Monthly progress reports to the NIH that will include:

o Summary of the number of Needs Assessment Reports completed since the last report and for which companies and projects, with the funding Institute or Center (IC) indicated;

o Needs Assessment Reports in development, including company name, project title, IC, and estimated time to complete assessment;

o Description of any problems that may have incurred during the analysis and report preparation process;

o Solutions for resolving any issues that may have occurred during the reporting period;

o Statement as to if the contractor(s) are meeting, and expect to continue to meet, their deadlines for providing the Needs Assessment Reports. If the contractor anticipates a delay in delivery, an explanation for anticipated delays shall be provided.

• Individual and aggregate analyses of Needs Assessment surveys to NIH annually, which will include at a minimum:

o a list of the number of assessments completed;

o description of industries represented (industries to be agreed upon with Technical Monitor);

o break out the Institutes and Centers supporting the Small Business

Concerns.

• Satisfaction Surveys o See Section 1.4 above for details.

• Transition Plan o See section 1.5 above for details.

Technical Category 2 – Needs Assessments

The Contractor shall:

• Gather from each selected SBIR/STTR awardee (hereafter awardee) pertinent, non-proprietary information concerning the life science technology, the company's intended use of the product/service to be developed, and the company’s awareness of and maturity in business areas (listed below) required to develop the product or service toward patient access.

a) Target market(s) attractiveness (this section will include information such as, but not limited to, definition and validation of primary and secondary/tertiary markets size, influencers)

b) Technology/solution’s ability to address market need (this section will include information such as, but not limited to, defining market need, key products/services pipeline)

c) Regulatory/certification path (this section will include information such as, but not limited to, manufacturing, clinical development timeline, clinical trial design, study design & protocol writing, strategy and preparation needed for agency engagement)

d) Business model profitability (this section will include information such as, but not limited to, cost of goods/services, cost of technology and comparators, operating and production costs, scalability)

e) Reimbursement (this section will include information such as, but not limited to, current payment models in the market, payment and coverage/pricing strategy, commercial insurance/Medicare/Medicaid, coding/coverage/payment history)

f) Competitive Advantage and Intellectual Property (this section will include information such as, but not limited to, competing technologies and products including associated IP with feature/benefit tradeoffs, market/industry trends, barriers to entry, key claims, IP status, patentability, freedom to operate)

g) Market Access/Sales and marketing strategy (this section will include information such as, but not limited to, licenses, sales/distribution channels, market positioning and segmentation, launch plans)

h) Management team (this section will include information such as, but not limited to, strength of business and technical leadership, experience, advisory board/board of directors)

i) Strategic partners (this section will include information such as but not limited to partnering strategy, current partners, identification of potential or essential partners both upstream and downstream)

j) Funding status/ Financial plan/Potential Exit Plan (this section will include information such as but not limited to resource requirements and strategy, potential sources of future capital, value creating milestones, major capital expenditure, and exits including potential acquirers and IPO)

• Provide summarized analyses of each commercialization area (a-j) outlined above from a life science industry perspective and in a contractor-developed template format within 6 weeks of assignment. These analyses shall include;

o Analysis of the current state of company and life science project;

o Analysis of each commercialization area (a-j) with respect to the scientific focus of the project and appropriate life science business area;

o Identification of strengths and weaknesses for each of the indicated commercialization areas and assignment of a standardized risk score or readiness level for each category;

o A summary of the commercial areas of highest priority the company should address to progress to the next value inflection point for the product/service being developed, and o Identify resources and contacts as appropriate in each of the 10 sections that the awardee can use to enhance the development of their product or service.

• The contractor shall propose a risk score/readiness level scale that will be applied to the analysis of each commercialization category within this Needs Assessment Report template and provide the documentation to support the score/scale relevance to product development within the life science industry.

• The contractor shall coordinate and conduct at least two phone conversations with the awardee:

o At the early stages of analysis (at least 90% of first calls are to be completed within the first two weeks of company identification/assignment), the contractor shall speak with the awardee to gather information to be used in developing the Needs Assessment Report;

o Within one month after delivery of the Needs Assessment Report, the contractor shall speak with the awardee to ensure the small business understands the information conveyed in the report and to discuss the relative prioritization of identified needs. The program officer for the award and a representative from SEED shall be invited to the post-delivery conversation.

• Provide a Needs Assessment Report to the awardee, the NIH Program Officer/COR for the awardee’s contract, Technical Monitor, CO, and COR for this contract. The Needs Assessment Report shall contain the following sections:

o A brief summary about the awardee and the product or service they are developing with HHS/NIH funding;

o A one-page summary and analysis of each commercialization area (a-j) outlined above including a risk score or readiness level for each category;

o A one-page summary identifying the most imperative needs for the small business to address as they progress to their next corporate milestone and any known NIH, local, regional, or sector-specific programs or resources the small business may apply for to address those needs;

o A proposed action plan that addresses the most imperative needs.

• The Needs Assessment Report shall be provided in a contractor-developed template format with the following characteristics:

o Presented in a Word and PDF format o Written in business language, avoiding overly technical language and jargon o Include headings, bullets, and use of white space to make the report easy to navigate and read o Incorporate tables and other graphics to simplify the information presented where appropriate o Include an Appendix with the references and resources cited throughout the report o Include the proposed resources by each commercialization area o A total report length of 13 pages, with one page describing each of the following:

summary/analysis of the project and company each of the 10 required commercialization areas, with an associated risk score/readiness level (to be proposed and justified by the contractor) recommended actions and resources for the company to refer to as they continue to develop their product or service a prioritized action plan summarizing and supporting the most immediate recommended actions

DELIVERABLES

Technical Category 2 – Deliverables:

• Four (4) copies of each Needs Assessment Report shall be provided (one to the SBIR/STTR awardee, a second to the NIH Program Officer/COR for the awardee, the third to the Technical Monitor for this contract, and the fourth to the CO and COR for this contract). Copies shall be provided in electronic format.

• Annually, provide digital copies of all Need Assessments completed during the contract period to the Technical Monitor, CO, and COR.

Attachment A: DRAFT Innovator Satisfaction Survey

Attachment 3 – Reporting Requirements/Deliverables

TECHNICAL REPORTING REQUIREMENTS AND DELIVERABLES

The items specified below as will be required to be delivered F.O.B. Destination as set forth in FAR Clause 52.247-35, F.O.B. Destination, Within Consignees Premises (April 1984), and in accordance with and by the date(s) specified below and any specifications stated in the contract.

a. Technical Reports Delivery and Distribution Schedule:

ITEM

TYPE OF DELIVERABLE

DUE DATE

RECIPIENTS &

NUMBER OF COPIES

1 Monthly Status Reports that includes Master list of Risks and issues.

Fifth (5th) working day of each month, starting after the first full month of the contract

Electronic copy to CO, COR and Technical Monitors (TM)

2 Proposed Project Management Plan

One (1) week ahead of Kick- Off Meeting

Electronic copy to COR, CO, and

TM

3 Final Project Management Plan

Four (4) weeks after the Kick-Off Meeting

Electronic copy to COR, CO, and

TM

4 Individual and Aggregate Analysis of Needs Assessment Survey’s

Annually, starting after award of contract

Electronic copy to COR, CO, and

TM

5 Notification of results of Dissatisfaction for Needs Assessment Survey

Within five (5) working days of receipt of survey

Electronic copy to COR, CO, and

TM

Draft Transition Plan Four (4) months before the end of the contract

Electronic copy to CO, COR and TM

7 Final Transition Plan Ten (10) weeks before the end of the contract

Electronic copy to CO, COR and TM

8 Individual Needs Assessment Report

Frequency to be determined after award of contract

Four (4) electronic copies to SBIR/STTR Awardee, SBIR/STTR Awardee NIH PO/COR, TM and

CO/COR

9 Needs Assessment Reports Annually (towards the end of each period of performance) – Frequency will be determined after award of contract

Electronic copy to CO, COR and TM

Attachment 8

ADDITIONAL TECHNICAL AND BUSINESS PROPOSAL INSTRUCTIONS and Uniform Cost Assumptions

In addition to the format requirements for the Business Proposal that are contained in Section J of the solicitation, the information presented here intends to provide uniform cost assumptions and business clarifications to assist in the preparation of your proposal.

TECHNICAL PROPOSAL INSTRUCTIONS:

1. Page Length (Technical Proposal): Technical Proposals shall not exceed 25 pages in length. This page count does not include a cover letter, sample assessments, resumes, or past performance examples. Any pages exceeding the above mentioned page limit will not be reviewed by the Technical Evaluation Panel.

2. Sample Assessments: The offeror must submit a number of sample assessments sufficient to provide two (2) examples covering each of the ten (10) commercialization areas identified in the Statement of Work. The offeror shall submit no more than two (2) examples for each commercialization area. Each sample assessment shall be limited to a maximum of twelve (12) pages: 1 page for summary, 1 page per commercialization area, and 1 page of key prioritizations.

EXAMPLE: Four (4) assessments are necessary to cover each commercialization area. The offeror shall submit four (4) summaries [one for each assessment], 20 pages covering each commercialization area [one page per area covered twice], and four (4) pages covering key prioritizations. Total number of pages: 28.

3. Page Layout: Pages shall have uniform 1 inch margins on all sides. Technical Proposal must use a 12-point Times New Roman font. One exception to font size is tables and charts. Tables and Charts may use 10-point Times New Roman font. A maximum of three tables/charts can be 11 inches x 17 inches (double page) in size.

4. Key Personnel: Commitment letters must be submitted for all proposed key personnel. Resumes for key personnel are limited to 2 pages in length.

5. Resumes: Resumes must be provided for all named personnel (both key personnel and non-key personnel). Resumes are limited to 2 pages per resume. Actual resumes are required – sample resumes for positions are not acceptable.

6. Past Experience: The Offeror shall provide 3 examples of past performance/experience. The list of examples shall not exceed 1 pages per example. Past experience examples must include contact name, position, telephone number, and email address. Past experience must also include an brief explanation as to the relevance of the past experience for this proposal. Any pages in excess of the above mentioned limitation will not be reviewed by the Government.

COST/EFFORT ASSUMPTIONS:

1. The price per assessment will be inclusive of all costs required.

Attachment 8

2. The following number of assessments are anticipated as a minimum amount for each contract period:

Base Period: 400 Assessments Option Period 1: 100 Assessments Option Period 2: 100 Assessments Option Period 3: 100 Assessments Option Period 4: 100 Assessments

3. The following number of assessments are to be included as Optional Additional Quantities for each contract period:

Base Period: 0 Assessments Option Period 1: 300 Assessments Option Period 2: 300 Assessments Option Period 3: 300 Assessments Option Period 4: 300 Assessments

Attachment 8 - ADDITIONALtechBusProposalInst