New York Codes, Rules and Regulations
Title 21 - Miscellaneous
Chapter L - New York State Urban Development Corporation
Part 4255 - Life Sciences Initiative Program
Section 4255.3 - New York Fund for Innovation in Research and Scientific Talent (NYFIRST) Program

Universal Citation: 21 NY Comp Codes Rules and Regs ยง 4255.3

Current through Register Vol. 46, No. 12, March 20, 2024

(a) Authority and purpose.

The New York State Urban Development Corporation hereby establishes the New York Fund for Innovation in Research and Scientific Talent (NYFIRST) Program as a component of the Life Sciences Initiatives Program. NYFIRST is intended to encourage the recruitment and retention of exceptional life science researchers and world-class talent at the state's medical schools to accelerate translational research. The recruited or retained researchers will demonstrate proven scientific accomplishments and a history of entrepreneurship and grant funding. NYFIRST funds will be used to support the establishment or upgrading of laboratories for these researchers, for purchases of capital equipment and specialized supplies needed for their research, and as working capital to cover costs of professional staff (including staff scientists, doctoral students/post-doctoral fellows, and technicians, but excluding the recruited researcher) critical to the proposed research.

The NYFIRST Program is intended to:

(1) increase the number of patent applications and patentable discoveries at medical schools and the number of patents from these schools;

(2) increase the recruitment/retention rate of medical school faculty focused on translational research;

(3) enhance and expand the expertise, qualifications and capabilities residing within these institutions; and

(4) increase Federal and philanthropic funding, as well as venture capital funding, to medical schools awarded NYFIRST grants.

(b) Definitions.

For the purposes of this section, the terms below shall have the following meaning:

(1) Applicant or eligible applicant shall mean a medical school within the State that applies for NYFIRST assistance.

(2) Corporation or ESD shall mean the New York State Urban Development Corporation doing business as Empire State Development.

(3) Eligible project shall mean a project that meets the eligibility criteria set forth in subdivision (d) of this section.

(4) Federal assistance shall mean funds available, other than by loan, from the Federal government, either directly, or through allocation by the State for program purposes pursuant to any Federal law or program.

(5) Life sciences economic development benefits shall mean the creation, expansion, enhancement or acceleration of life sciences programs throughout the State that lead to:
(i) the commercialization of life sciences in New York State;

(ii) the creation or retention of jobs in the life sciences industry employing full time permanent employees;

(iii) the promotion of the life science ecosystem within a region of the State;

(iv) new patents in life science;

(v) additional commercial laboratory space; or

(vi) additional venture capital money for life sciences entities in New York State.

(6) Match, matching share, or matching funds shall mean that portion of the total cost of a project that the grantee must provide, pursuant to paragraph (c)(2) of this section.

(7) Medical school shall mean a public or private medical school in New York State that is accredited by the liaison committee on medical education or the commission on osteopathic college accreditation, or such medical school together with an affiliated entity, located in New York State.

(8) Principal investigator shall mean the holder of an independent grant administered by a university and the lead researcher for the grant project who makes the final decisions and supervises funding and expenditures on a given research project.

(9) Project shall mean the scope of activities supported by a NYFIRST Program grant and the grantee's matching share.

(10) Reimbursable expenses shall mean approved costs incurred by the NYFIRST grantee to perform the project. Reimbursable expenses must be incurred during the grant term. An item included as a match cannot also be included as a reimbursable expense.

(11) Specialized supplies shall mean consumables, including, but not limited to, antibodies, assay kits, proteins, reagents, enzymes, DNA/RNA and PCR products, nucleosides and nucleotides, specialized media, substrates and other bioproducts required to conduct the research specified.

(12) Translational research shall mean research that applies, or translates, existing knowledge about biology into techniques and tools for treating human disease: translational research takes knowledge from bench to bedside. This differs from academic research, which is focused on careful study of a subject or field to discover facts or principles that are added to the general body of scientific knowledge.

(c) Available program assistance.

(1) The NYFIRST Program makes available financial assistance in the form of grants to applicants for eligible projects. The maximum grant amount for any eligible project is $1 million.

(2) Matching funds. Grantees will be required to provide $2 of matching funds for every $1 of NYFIRST Program assistance. The match is a non-reimbursable component of the project's total cost and is reflective of the grantee's long-term commitment to the project.
(i) The match provided by the grantee may be cash, including Federal assistance, or in-kind services. If in-kind services any match item may be donated by the grantee or reflect the grantee's use for the project of such an item donated by a third party (such as industry or alumni/ae). However, no financial assistance made available to the grantee by the corporation or any other New York State agency or public authority may be included as part of any program grantee's match. Nothing in this subdivision shall prohibit the State University of New York or the City University of New York from using a portion of their respective operating funds as match.

(ii) Items eligible to be approved are matching funds directly related to the purpose of the project including, but not limited to: compensation for the recruited principal investigator meeting the eligibility criteria described in paragraph (d)(3) of this section; financial support for research staff and graduate students who are members of the newly recruited principal investigator's team; relocation expenses for the aforementioned principal investigator or associated team; other expenses as are necessary for recruitment purposes; the cost of preparing and equipping work space for the principal investigator or associated team; other expenses required to conduct the relevant research undertaken by the principal investigator or associated team such as laboratory supplies; and the cost of new faculty lines in research areas to complement the recruited principal investigator and his/her team.

(iii) All matching funds must be expended during the program grant term and where practicable on a pro rata basis with program grant funding.

(iv) All items identified as matching funds will be reviewed by the corporation, which will approve such matching funds as the corporation may determine, in its sole discretion, to be reasonable as to amount and relation to the project.

(3) Program grant funds will be disbursed on a semiannual reimbursement basis. Grantees shall submit quarterly invoices twice yearly with and supporting documentation satisfactory to the corporation, as work is performed and costs incurred.

(d) Eligibility criteria.

(1) Program grants are intended to encourage the recruitment and retention by the State's medical schools of exceptional life science researchers and world-class talent focused on accelerating translational research. NYFIRST grants may be used to support the establishment or upgrading of laboratories for these researchers, for purchases of capital equipment and specialized supplies needed for their research, and as working capital to cover costs of professional staff (including staff scientists, doctoral students/post-doctoral fellows, and technicians, but excluding the recruited principal investigator) critical to the proposed research.

(2) ESD will make no more than one award per applicant per application cycle.

(3) The scientific talent recruited or retained as a principal investigator to head a laboratory must:
(i) demonstrate a record of translational research with clear potential for commercialization;

(ii) demonstrate that the research to be undertaken focuses on the development of an innovative solution for an identified healthcare-related problem, with the potential to result in significant life sciences economic development benefits in New York State;

(iii) demonstrate a history of entrepreneurship such as by patent applications, patent approvals and commercialization of research and by success in obtaining funding;

(iv) have sufficient funding to support the project being undertaken for three years;

(v) be tenured or be on a tenure track and provide sufficient documentation to ESD to corroborate such track;

(vi) hire or retain (or cause to be hired or retained by the medical school) at least two scientists or doctoral students/post-doctoral fellows full-time (40hrs/week) or at least four scientists or doctoral students/post-doctoral fellows who each work a minimum of 20hrs/week; the scientists and post-doctoral fellows must be recruited from outside of New York State; and

(vii) be employed by an institution or company outside New York State at the time an offer of employment is made by the applicant, or have a verifiable offer from an institution from another state that would lead him/her to leave New York State. (See paragraph [e][2][ii] of this section.)

(4) The offer of employment to the principal investigator by the applicant must be made between the date of availability of the NYFIRST application for a given application cycle and the application deadline for that cycle. Acceptance of such offer also must occur between the date of availability of the NYFIRST application for a given application cycle and the application deadline for that cycle.

(5) A copy of the accepted employment offer must be submitted with the NYFIRST application.

(6) The grant term is four years, and all expenditures for which program funding is approved must be commenced and completed no more than four years from commencement of the grant. The corporation, in its sole discretion, may terminate the program grant for any eligible project that does not adhere to the timelines established in the grant agreement or otherwise fails to demonstrate satisfactory performance.

(e) Application requirements, process and evaluation.

(1) On an application provided by ESD, the applicant shall provide such information about the applicant, the principal investigator and the project as ESD may require. The application shall highlight the following information relevant to the research being undertaken: unmet clinical need, market potential, and an approximate timeline and anticipated steps to market/clinical use. There are no restrictions in terms of therapeutic area of research. The completed application shall illustrate how the applicant has met the criteria established in paragraph (d)(3) of this section and also will include details regarding the following:
(i) therapeutic need for the research e.g., extent of the unmet need for therapeutics, diagnostics or other intellectual property; what alternatives are already available, market size, and market environment;

(ii) anticipated path to commercialization; key milestones to be met as this research moves toward commercialization;

(iii) uniqueness of the research and competitive edge;

(iv) summary of supporting proof of concept data and other relevant research, and publications;

(v) strength of principal investigator's intellectual property/entrepreneurial history and intellectual property potential and patent considerations of proposed research;

(vi) proposed scope of work, timeline and the feasibility of timeline;

(vii) profile(s) of the recruited or retained principal investigator and the proposed team members;

(viii) budget;

(ix) total amount of NIH and other funding that will accompany the recruited principal investigator as well as his/her funding history; and

(x) documentation establishing that the term of employment between the institution (the grantee) and the principal investigator, as well as each member of the team accompanying the principal investigator is, at a minimum, for a period coextensive with the grant term.

(2) The application must also be accompanied by:
(i) a signed statement of support of the proposed project executed by the chief executive officer or dean of the applicant medical school, and in a format approved by the corporation, recommending the application to the corporation and authorizing an official of the applicant institution to execute documents necessary for the project;

(ii) a copy of the dated and accepted offer letter by the principal investigator, indicating the specific position offered and tenure status and including agreement on anticipated commencement of employment. (Confidential information unrelated to the position, date of offer and signed acceptance may be redacted) or, in the case of retention of a principal investigator considering an offer from an institution outside of New York State, a signed statement by the chief executive officer or dean of the applicant medical school, verifying that the principal investigator had indicated his/her intention to relocate to another institution outside of New York State, with details regarding the potential offer, including position and salary, and that a counteroffer has been made and accepted. A copy of the counteroffer and of the acceptance of same must be provided;

(iii) verification that the recruited principal investigator was employed at an institution from outside of New York State prior to receipt and acceptance of the offer letter; and

(iv) such other information as the corporation may require to implement this program.

(3) To the extent practicable, ESD will attempt to make awards to as many medical schools as possible within the State, assuming equivalent qualifying evaluation scores and taking into consideration regional balance, anticipated job creation and retention and economic development benefits.

(f) Selection criteria/scoring.

(1) Applications will be evaluated on the criteria detailed in subdivision (d) of this section and the documentation provided pursuant to paragraph (e)(1) of this section on a scale of one to five, where:

1 = does not meet qualification expectation;

3 = meets qualification expectations; and

5 = exceeds qualification expectations.

(2) Selection criteria will be weighted as follows:

Criteria CategoryWeight
1. Unmet need30%
2. Novelty & competitiveness of proposed solution30%
3. Preliminary/supporting data15%
4. Strength of principal investigator's intellectual property history and patent potential of proposed research15%
5. Feasibility of development timeline10%

(3) The corporation intends to make program grant awards through a competitive grant solicitation to qualifying applicants twice annually until the funds under this program are fully committed.

(4) For each application cycle, the period between application availability and the application deadline shall be six months.

(g) Eligible uses.

(1) Program grants must be used for expenses directly related to the eligible project including but not limited to:
(i) costs relating to the design, acquisition, construction, reconstruction and rehabilitation of laboratory space;

(ii) capital equipment purchases;

(iii) specialized supplies purchases; and

(iv) working capital to cover costs of professional staff critical to the research to be undertaken by the principal investigator (including staff scientists, postdoctoral fellows and technicians, but excluding the principal investigator).

(2) The corporation may determine not to reimburse eligible expenses if the award recipient fails to maintain its required level of match during a specific grant disbursement period.

(3) Program grants shall not duplicate payments received, or receivable, from other sources.

(h) Reporting requirements.

(1) The corporation is required by statute to submit to the Governor, the temporary president of the New York State Senate, and the speaker of the New York State Assembly an annual report on the operations and accomplishments of the life sciences initiatives programs on or before October 1st annually. The report must include, but is not limited to, information and statistics detailing the economic impact of the activities undertaken with program funds; the number and amount of Federal funds procured after an investment of program funds; jobs created and maintained after receipt of program funds; and the average salaries of such jobs created and maintained.

(2) The corporation will establish periodic reporting requirements for program grantees to provide information to the corporation so that the corporation may accomplish its statutory reporting obligations. These reporting obligations may extend beyond the completion of the project for a period of three years.

(3) Failure by a grantee to provide the required information in a manner that is timely and otherwise satisfactory to the corporation may subject the grant to full or partial recapture.

The amended version of this section by New York State Register December 22, 2021/Volume XLIII, Issue 51, eff. 12/22/2021

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