Frequently asked questions

US based life science companies are eligible for the majority of granting sources including the NIH institutes (NCI, NHLBI, NINDS, NIAID, NIA, NEI, NIDDK, NIBIB, NIMH, etc.), DOD (US Army, DTRA, DARPA, CDMRP), BARDA, NSF, FDA, Private Foundations etc., with the exception of strictly academic programs such as center grants, or program projects within the NIH. Small business, that meet the SBIR/STTR eligibility criteria (see more here: https://www.sbir.gov/faqs/eligibility-requirements), can submit to phased SBIR/STTR programs and win grants from $250,000 (Phase I) and upwards of $2,000,000 (Phase II).

Yes! non-US organizations are eligible to apply for the majority of US-based grants. That being said, non-US applicants are not eligible for the small business program (SBIR/STTR) as that is reserved for US small business only.

Awards vary based on the mechanism of support and corresponding stage of development. For early exploratory programs, awards are in the ~$250,000 – $300,000 (SBIR/STTR Phase I, R21). More advanced programs such as SBIR Phase II are in the $2,000,000 range and R01s, U01,s can be $3,000,000 and even higher if justified. Clinical stage programs are in the $5,000,000 and higher range, though depends greatly on the mechanism of support, whether NIH, DOD or BARDA. The latter are known to award tens of millions and at times hundreds of millions for clinical stage programs.

To submit an application an organization must be registered to the relevant government portals. First, register your company in the System for Awards Management (SAM.gov), a process which will require creating an account for 2-step authentication which will also be used in other government portals. As part of SAM registration, your company will be assigned a Unique Entity Identifier (UEI), which serves as your company’s ID for all future government registration purposes. Then register to Grants.gov, and to the relevant government agency portal – eRA Commons for NIH, eBRAP for DoD, Research.gov for NSF, Small Business Administration for SBIRs. Some specific government opportunities, as well as most state-level or private foundation funding sources, have their own submission portals which often require registration and account creation (typically a simple process).

If all goes well, registration can be completed in a few weeks – 3 or 10 days for SAM (depending on type of funding opportunities selected), up to 14 days for the NIH’s eRA Commons, and a quick 24-48 hours or so for the other portals. Non-US companies wishing to do business with the US Government will need to obtain an NCAGE, which can take up to 10 days as well. However, things do not always go smoothly, as various government agencies need to confirm the registrations.

Start registration early, be diligent in following through until it is complete, and give yourself a few months of space to make sure everything is in order and submissions aren’t jeopardized.

FreeMind highly recommends starting to draft your proposal at least 6-8 weeks in advance of the deadline. At times you would need to identify collaborators or sub-contractors which can be time consuming. Start by outlining the project from a high-level (specific aims, milestones, relevant scientific background, innovation, main experiments etc.). Once you have that in place start filling in the gaps until the application is complete. When waiting on third parties for input, this can result in last minute contributions and a tight deadline. So start early!

Depending on the source of funding, NIH vs. DOD, vs. BARDA, the review process takes some 7-8 months. Specifically, at the NIH, your application is externally peer reviewed some 3-4 months from the submission date by 3 to 4 reviewers. The study section will convene some 3-4 months after that and a decision will be made whether to award the application or not.

The reviewers at the NIH review the application for 5

1. Significance to public Health

2. Innovation

3. Leadership

4. Environment

5. Research Approach

Each reviewer provides a numerical for each review criteria between 1 and 9, where 1 is outstanding, and 9 poor. the reviewer also provides a verbal description of the strengths and weaknesses of each review criteria. Reviews are aggregated and applications stacked against each other. The bottom 50% are marked as “not discussed” and will not be awarded. The top 50% receive a priority score between 10 and 90, where 10 is a perfect outcome. Typically a priority score of below 30 is fundable with exceptions in either direction. Roughly 3-4 months from the receipt of the initial review the study section will convene and a decision will be made.

Each reviewer provides a numerical for each review criteria between 1 and 9, where 1 is outstanding, and 9 poor. the reviewer also provides a verbal description of the strengths and weaknesses of each review criteria. Reviews are aggregated and applications stacked against each other. The bottom 50% are marked as “not discussed” and will not be awarded. The top 50% receive a priority score between 10 and 90, where 10 is a perfect outcome. Typically a priority score below 30 is fundable with exceptions in either direction. Roughly 3-4 months from the receipt of the initial review the study section will convene and a decision will be made.

NIH provides some potent tools to protect the applicant’s proprietary information. Each line containing proprietary information can be specifically marked. Reviewers of the study section assigned, all need to sign a CDA. In addition, the review panel is made public prior to review and we would be able make sure none of the members have any conflict of interests. The application itself is confidential (excluding the abstract) and cannot undermine the novelty of any future patent filings as it is not in the public domain, or accessible to a person skilled in the art.

Intellectual Property – as long as award recipients comply with the provisions of the Bayh-Dole Act they have the right to retain title to any invention conceived or first actually reduced to practice using HHS grant funds. The principal objectives of these laws and the implementing regulation are to promote commercialization of federally funded inventions, while ensuring that inventions are used in a manner that promotes free competition and enterprise without unduly encumbering future research and discovery.

“HHS recipients may retain intellectual property rights to subject inventions provided they do the following: • Report all subject inventions to the OPDIV • Make efforts to commercialize the subject invention through patent or licensing • Formally acknowledge the Federal government’s support in all patents that arise from the subject invention • Formally grant the Federal government a limited use license to the subject invention.”

Enacted in 1980, the basic underlying rationale behind all of the guidelines and regulations is that entities will retain the IP right on inventions developed using federal money as long as they comply with progress reporting. The Bayh-Dole Act encourages researchers to patent and market their inventions by guaranteeing patent rights. This Act automatically grants first rights to a patent for an invention fully or partially funded by a Federal agency to the awardee organization.

More information: The Bayh-Dole Act https://grants.nih.gov/grants/bayh-dole.htm

March-in rights give the federal government the right to grant other entities licenses or give a license to themselves if they aided the owner of a patent with funding. The government will not use their march-in rights unless there is a threat to public safety that the owner of the patent is not equipped to handle. This provision in Bayh-Dole, basically allows the funding agency, on its own initiative or at the request of a third party, to effectively ignore the exclusivity of a patent awarded under the act and grant additional licenses to other “reasonable applicants.” This right is strictly limited and can only be exercised if the agency determines, following an investigation, that one of four criteria is met. The most important of these is a failure by the contractor to take “effective steps to achieve practical application of the subject invention” or a failure to satisfy “health and safety needs” of consumers. Though this right is, in theory, quite powerful, it has not proven so in terms of its practical application — to date, no federal agency has exercised its march-in rights.

More information: 35 U.S. Code § 203 – March-in rights https://grants.nih.gov/grants/bayh-dole.htm#401.6

Except for the March-in rights, reporting and sharing of research findings, as an awardee you are not obligated to provide anything in return to the granting agency. Given the mechanism is a grant, no money needs to be returned upon completion, no matching funds required, or any royalty payments due.

Allowable costs are any direct costs associated with the project. For example, materials, salaries (certain percent effort), animal costs, patient/hospital costs, sub-contractors such as CROs etc. On top of the Direct cost you can also request 35-40% overhead – also referred to as indirect costs, (or 8% in the case of non-US applicants). Examples of costs that are not allowed are IP costs, cost of preparing an IND and typically equipment.