Boost Biotech Startups

Section 1. Legislative intent. The legislature hereby finds and declares that a coordinated program of research, entrepreneurship, and public-private partnerships and collaborations centered in and with the state's public and private medical schools can significantly increase the speed and amount of commercialization of research from lab to market, materially expanding economic and job opportunities for all New Yorkers in this high growth sector and increasing the likelihood of high impact healthcare breakthroughs, which will improve the health and wellbeing of New Yorkers and potentially reduce health care costs.

The legislature further finds that although New York state's biomedical and biotechnological research and infrastructure includes many of the nation's top institutions, researchers and scientists, and has many natural advantages compared to other states, development has lagged behind the nation as a whole and many states in job growth and economic activity for a decade; and further, that as other states make significant and targeted investments to recruit top tier scientists and researchers, and develop incentives that are creating rapid growth, the gap between New York and other states will increase, along with a potential migration of scientific and research talent to other states in search of opportunity and professional advancement.

The legislature further finds that recent changes that have made New York's economic development programs more sophisticated and competitive can be combined with other statutory approaches and precedents to support and incentivize an effective plan for development of biomedical and biotechnological entrepreneurship by and through the medical schools in this state, and declares that the program enacted by this act will expand economic activity and job development; maintain and attract high quality scientists and researchers; increase resources available to the schools and researchers from grants, private investments, patents,

EXPLANATION--Matter in italics (underscored) is new; matter in brackets

[ ] is old law to be omitted.

LBD01066-01-7

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royalties, and licensure, and leverage significant partnerships with public and private entities; enhance our scientific and research capabilities; and increase the speed of commercialization of research and the expansion of economic opportunity, which are in every sense to the benefit of the people of this state.

§ 2. The economic development law is amended by adding a new article 23 to read as follows:

ARTICLE 23

THE NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL

TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE Section 451. Short title.

452. Definitions.

453. New York state biomedical and biotechnological translation-

al research and entrepreneurship initiative committee.

454. Application for designation as a New York state biomedical

and biotechnological translational research and entre-

preneurship initiative center.

455. Review and approval of applications.

456. Waiver in certain cases.

457. Operation and re-designation of New York state biomedical

and biotechnological translational research and entre-

preneurship initiative centers.

458. Scientific research and discovery bank program.

459. Unified contract.

§ 451. Short title. This article shall be known and may be cited as the "New York state biomedical and biotechnological translational research and entrepreneurship initiative".

§ 452. Definitions. As used in this article:

1. "Medical school" means a public or private medical school accredited by the liaison committee on medical education or the commission on osteopathic college accreditation, or such medical school and an affiliated entity, located in this state.

2. "New York state incubators" and "New York state innovation hotspots" or "incubators" and "hotspots" mean and refer to "New York state incubators" and "New York state innovation hotspots" designated pursuant to section sixteen-v of the urban development corporation act.

3. "Peer review committee" means the peer review committee created by the department and the department of health, consisting of scientific and research experts in biomedical and biotechnological development, and company representatives at the executive officer level engaged in making development, financing, and commercialization of biomedical and biotechnological research.

4. "Plan" means the multi-year plan that accompanies the application of a medical school to become a New York state biomedical and biotechnological translational research and entrepreneurship initiative center.

5. "Project" is the execution of an approved plan by a New York state biomedical and biotechnological translational research and entrepreneurship initiative center.

6. "START-UP NY" program means the START-UP program authorized pursuant to article twenty-one of this chapter, and the "tax-free NY area" has the same meaning as in article twenty-one of this chapter.

7. "State initiative committee" or "state committee" means the biomedical and biotechnological translational research and entrepreneurship initiative committee created by section four hundred fifty-three of this article.

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8. "Translational research and entrepreneurship center" or "center" is the New York state biomedical and biotechnological translational research and entrepreneurship initiative center created at a medical school pursuant to this article.

9. "Unified contract" is the contract between the department and a medical school that includes all items necessary to the implementation and administration of the New York state biomedical and biotechnological translational research and entrepreneurship initiative project as described in this article by a center.

§ 453. New York state biomedical and biotechnological translational research and entrepreneurship initiative committee. The New York state biomedical and biotechnological translational research and entrepreneurship initiative committee is hereby created, to consist of the commissioners of the departments of health, education, economic development, labor, tax and finance, the chancellor of the state university of New York, the chancellor of the city university of New York, the president of the empire state development corporation, the director of the division of the budget, and the state comptroller. The committee shall be chaired by the commissioner of economic development, and co-chaired by the commissioner of health. Commissioners may be represented by designees at meetings of the committee.

1. Powers and duties. The committee shall:

(a) Establish guidelines appropriate to the activities required under this article.

(b) Designate as New York state biomedical and biotechnological transitional research and entrepreneurship initiative centers medical schools which meet the criteria established in this article.

(c) Approve waivers of regulations and procedures pursuant to section four hundred fifty-seven of this article.

(d) Establish a unified contract for projects pursuant to section four hundred fifty-nine of this article.

(e) Receive and review performance metrics reports from centers.

(f) Re-designate the centers every five years pursuant to this article.

(g) Develop resources and procedures to aid in commercialization of research and funding of entrepreneurial efforts created as a result of projects, including but not limited to such activities as procurement of goods or services from companies created in the projects; endorsing, collaborating, or upon request of a center, acting as a co-principal investigator or other level of participant on grants or other activities that will aid in furthering project activities; and such other activities as can aid rapid commercialization as are permissible under law.

(h) Oversee and make recommendations for approval of applications to the scientific research and discovery bank created by this article for the recruitment of out of state and retention of in-state star scientists and researchers.

(i) Upon request, provide technical assistance to applicants, and as may be needed for successful implementation of a project, including but not limited to assistance in identifying and obtaining resources and funding.

(j) Identify statutory requirements that the committee views as impediments to successful implementation of approved plans, and as necessary, submit requests to the legislature in accordance with article VII of the state constitution for specific legislative enactments necessary to remove such impediments.

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(k) Enter into agreements between and among the members of the committee as necessary to delineate their respective roles regarding the cooperative provision of funding and assistance.

2. The committee may act through its chairs in all matters of oversight and implementation of the program authorized by this article.

§ 454. Application for designation as a New York state biomedical and biotechnological translational research and entrepreneurship initiative center. In response to a request for proposals, a medical school or a medical school and an affiliated entity may apply for funding and designation as a New York state biomedical and biotechnological translational research and entrepreneurship initiative center by submitting an application and plan to the commissioner. The commissioner shall forward all such applications to the peer review committee for review and recommendation as herein provided, and then to the state committee. In addition to such other items, warranties, and information as the state initiative committee may require, plans must show that the activities to be undertaken will commercialize research from lab to marketplace, demonstrate that the center meets the matching funds and entrepreneur relationship requirements hereunder, and meet a majority of the remainder of the following items:

1. Commitment: a multi-year commitment to implement the plan, over a period of not less than five years, demonstrated by a commitment of resources, personnel, and funds that the school will use, directly or through partnerships and collaborations, to provide and/or incentivize an integrated program of research, education, clinical practice, entrepreneurship, financing, partnerships, and rapid commercialization of research. Such demonstration may also include capital investments made or planned for new or rehabilitated research or laboratory space, continued support for activities after the conclusion of the project, and other activities demonstrating commitment.

2. Resources: a description of the actions and resources necessary to meet the plan objectives over its duration; a demonstration that the medical school has or is developing operational clinical facilities and expertise or evidence of bona fide collaborations and partnerships that can provide such facilities and expertise to successfully implement the plan; a demonstration that the project will have a professional management team with experience, expertise, or credentials in areas including but not limited to management, entrepreneurship, business development, or other equivalent areas. The demonstration may include recruitment plans or commitments for high level research professionals, including how the school would make use of the scientific research and discovery bank.

3. Entrepreneurial and research collaborations: evidence of bona fide entrepreneurial relationships with one or more incubators or hotspots, and research collaborations with other entities including but not limited to other research institutions, pharmaceutical and biomedical and biotechnology companies.

4. Leveraged and applied funding: a demonstration that the school already possesses or has a commitment for and will maintain during the plan period the required funding match ratio of at least two dollars for every state dollar provided pursuant to this article to an approved plan, and how the school will use other resources, partnerships, and collaborations to aid directly or indirectly in activities critical to the commercialization of research. Insofar as practicable, such matching funds should not consist of direct state grants from the department or from another state agency or state public authority, provided that noth-

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ing in this subdivision shall be deemed to prohibit a medical school of the State University of New York which has been designated as a center from using a portion of its operating funds as matching funds.

5. Additional plans and programs: other plans and programs integral to the successful execution of the project, including but not limited to patent and intellectual property plans, training and educational programs, and educational integration with research and clinical activities.

6. Community support: a demonstration of community support from business and government leaders and organizations.

7. Best practices: a demonstration that the medical school has or will adopt best practices and use of multi-year metrics for performance, and that it will report data as requested or required to the department and the state initiative committee.