Bill Text: NY S08549 | 2017-2018 | General Assembly | Introduced
Bill Title: Relates to the New York state biomedical and biotechnological translational research and entrepreneurship initiative.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2018-06-07 - REPORTED AND COMMITTED TO RULES [S08549 Detail]
Download: New_York-2017-S08549-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 8549 IN SENATE May 9, 2018 ___________ Introduced by Sen. BOYLE -- read twice and ordered printed, and when printed to be committed to the Committee on Commerce, Economic Devel- opment and Small Business AN ACT to amend the economic development law, in relation to the New York state biomedical and biotechnological translational research and entrepreneurship initiative The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Legislative intent. The legislature hereby finds and 2 declares that a coordinated program of research, entrepreneurship, and 3 public-private partnerships and collaborations centered in and with the 4 state's public and private medical schools can significantly increase 5 the speed and amount of commercialization of research from lab to 6 market, materially expanding economic and job opportunities for all New 7 Yorkers in this high growth sector and increasing the likelihood of high 8 impact healthcare breakthroughs, which will improve the health and well- 9 being of New Yorkers and potentially reduce health care costs. 10 The legislature further finds that although New York state's biomedi- 11 cal and biotechnological research and infrastructure includes many of 12 the nation's top institutions, researchers and scientists, and has many 13 natural advantages compared to other states, development has lagged 14 behind the nation as a whole and many states in job growth and economic 15 activity for a decade; and further, that as other states make signif- 16 icant and targeted investments to recruit top tier scientists and 17 researchers, and develop incentives that are creating rapid growth, the 18 gap between New York and other states will increase, along with a poten- 19 tial migration of scientific and research talent to other states in 20 search of opportunity and professional advancement. 21 The legislature further finds that recent changes that have made New 22 York's economic development programs more sophisticated and competitive 23 can be combined with other statutory approaches and precedents to 24 support and incentivize an effective plan for development of biomedical 25 and biotechnological entrepreneurship by and through the medical schools 26 in this state, and declares that the program enacted by this act will 27 expand economic activity and job development; maintain and attract high 28 quality scientists and researchers; increase resources available to the 29 schools and researchers from grants, private investments, patents, EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD01066-01-7S. 8549 2 1 royalties, and licensure, and leverage significant partnerships with 2 public and private entities; enhance our scientific and research capa- 3 bilities; and increase the speed of commercialization of research and 4 the expansion of economic opportunity, which are in every sense to the 5 benefit of the people of this state. 6 § 2. The economic development law is amended by adding a new article 7 23 to read as follows: 8 ARTICLE 23 9 THE NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL 10 TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE 11 Section 451. Short title. 12 452. Definitions. 13 453. New York state biomedical and biotechnological translation- 14 al research and entrepreneurship initiative committee. 15 454. Application for designation as a New York state biomedical 16 and biotechnological translational research and entre- 17 preneurship initiative center. 18 455. Review and approval of applications. 19 456. Waiver in certain cases. 20 457. Operation and re-designation of New York state biomedical 21 and biotechnological translational research and entre- 22 preneurship initiative centers. 23 458. Scientific research and discovery bank program. 24 459. Unified contract. 25 § 451. Short title. This article shall be known and may be cited as 26 the "New York state biomedical and biotechnological translational 27 research and entrepreneurship initiative". 28 § 452. Definitions. As used in this article: 29 1. "Medical school" means a public or private medical school accred- 30 ited by the liaison committee on medical education or the commission on 31 osteopathic college accreditation, or such medical school and an affil- 32 iated entity, located in this state. 33 2. "New York state incubators" and "New York state innovation 34 hotspots" or "incubators" and "hotspots" mean and refer to "New York 35 state incubators" and "New York state innovation hotspots" designated 36 pursuant to section sixteen-v of the urban development corporation act. 37 3. "Peer review committee" means the peer review committee created by 38 the department and the department of health, consisting of scientific 39 and research experts in biomedical and biotechnological development, and 40 company representatives at the executive officer level engaged in making 41 development, financing, and commercialization of biomedical and biotech- 42 nological research. 43 4. "Plan" means the multi-year plan that accompanies the application 44 of a medical school to become a New York state biomedical and biotechno- 45 logical translational research and entrepreneurship initiative center. 46 5. "Project" is the execution of an approved plan by a New York state 47 biomedical and biotechnological translational research and entrepreneur- 48 ship initiative center. 49 6. "START-UP NY" program means the START-UP program authorized pursu- 50 ant to article twenty-one of this chapter, and the "tax-free NY area" 51 has the same meaning as in article twenty-one of this chapter. 52 7. "State initiative committee" or "state committee" means the biomed- 53 ical and biotechnological translational research and entrepreneurship 54 initiative committee created by section four hundred fifty-three of this 55 article.S. 8549 3 1 8. "Translational research and entrepreneurship center" or "center" is 2 the New York state biomedical and biotechnological translational 3 research and entrepreneurship initiative center created at a medical 4 school pursuant to this article. 5 9. "Unified contract" is the contract between the department and a 6 medical school that includes all items necessary to the implementation 7 and administration of the New York state biomedical and biotechnological 8 translational research and entrepreneurship initiative project as 9 described in this article by a center. 10 § 453. New York state biomedical and biotechnological translational 11 research and entrepreneurship initiative committee. The New York state 12 biomedical and biotechnological translational research and entrepreneur- 13 ship initiative committee is hereby created, to consist of the commis- 14 sioners of the departments of health, education, economic development, 15 labor, tax and finance, the chancellor of the state university of New 16 York, the chancellor of the city university of New York, the president 17 of the empire state development corporation, the director of the divi- 18 sion of the budget, and the state comptroller. The committee shall be 19 chaired by the commissioner of economic development, and co-chaired by 20 the commissioner of health. Commissioners may be represented by desig- 21 nees at meetings of the committee. 22 1. Powers and duties. The committee shall: 23 (a) Establish guidelines appropriate to the activities required under 24 this article. 25 (b) Designate as New York state biomedical and biotechnological tran- 26 sitional research and entrepreneurship initiative centers medical 27 schools which meet the criteria established in this article. 28 (c) Approve waivers of regulations and procedures pursuant to section 29 four hundred fifty-seven of this article. 30 (d) Establish a unified contract for projects pursuant to section four 31 hundred fifty-nine of this article. 32 (e) Receive and review performance metrics reports from centers. 33 (f) Re-designate the centers every five years pursuant to this arti- 34 cle. 35 (g) Develop resources and procedures to aid in commercialization of 36 research and funding of entrepreneurial efforts created as a result of 37 projects, including but not limited to such activities as procurement of 38 goods or services from companies created in the projects; endorsing, 39 collaborating, or upon request of a center, acting as a co-principal 40 investigator or other level of participant on grants or other activities 41 that will aid in furthering project activities; and such other activ- 42 ities as can aid rapid commercialization as are permissible under law. 43 (h) Oversee and make recommendations for approval of applications to 44 the scientific research and discovery bank created by this article for 45 the recruitment of out of state and retention of in-state star scien- 46 tists and researchers. 47 (i) Upon request, provide technical assistance to applicants, and as 48 may be needed for successful implementation of a project, including but 49 not limited to assistance in identifying and obtaining resources and 50 funding. 51 (j) Identify statutory requirements that the committee views as imped- 52 iments to successful implementation of approved plans, and as necessary, 53 submit requests to the legislature in accordance with article VII of the 54 state constitution for specific legislative enactments necessary to 55 remove such impediments.S. 8549 4 1 (k) Enter into agreements between and among the members of the commit- 2 tee as necessary to delineate their respective roles regarding the coop- 3 erative provision of funding and assistance. 4 2. The committee may act through its chairs in all matters of over- 5 sight and implementation of the program authorized by this article. 6 § 454. Application for designation as a New York state biomedical and 7 biotechnological translational research and entrepreneurship initiative 8 center. In response to a request for proposals, a medical school or a 9 medical school and an affiliated entity may apply for funding and desig- 10 nation as a New York state biomedical and biotechnological translational 11 research and entrepreneurship initiative center by submitting an appli- 12 cation and plan to the commissioner. The commissioner shall forward all 13 such applications to the peer review committee for review and recommen- 14 dation as herein provided, and then to the state committee. In addition 15 to such other items, warranties, and information as the state initiative 16 committee may require, plans must show that the activities to be under- 17 taken will commercialize research from lab to marketplace, demonstrate 18 that the center meets the matching funds and entrepreneur relationship 19 requirements hereunder, and meet a majority of the remainder of the 20 following items: 21 1. Commitment: a multi-year commitment to implement the plan, over a 22 period of not less than five years, demonstrated by a commitment of 23 resources, personnel, and funds that the school will use, directly or 24 through partnerships and collaborations, to provide and/or incentivize 25 an integrated program of research, education, clinical practice, entre- 26 preneurship, financing, partnerships, and rapid commercialization of 27 research. Such demonstration may also include capital investments made 28 or planned for new or rehabilitated research or laboratory space, 29 continued support for activities after the conclusion of the project, 30 and other activities demonstrating commitment. 31 2. Resources: a description of the actions and resources necessary to 32 meet the plan objectives over its duration; a demonstration that the 33 medical school has or is developing operational clinical facilities and 34 expertise or evidence of bona fide collaborations and partnerships that 35 can provide such facilities and expertise to successfully implement the 36 plan; a demonstration that the project will have a professional manage- 37 ment team with experience, expertise, or credentials in areas including 38 but not limited to management, entrepreneurship, business development, 39 or other equivalent areas. The demonstration may include recruitment 40 plans or commitments for high level research professionals, including 41 how the school would make use of the scientific research and discovery 42 bank. 43 3. Entrepreneurial and research collaborations: evidence of bona fide 44 entrepreneurial relationships with one or more incubators or hotspots, 45 and research collaborations with other entities including but not limit- 46 ed to other research institutions, pharmaceutical and biomedical and 47 biotechnology companies. 48 4. Leveraged and applied funding: a demonstration that the school 49 already possesses or has a commitment for and will maintain during the 50 plan period the required funding match ratio of at least two dollars for 51 every state dollar provided pursuant to this article to an approved 52 plan, and how the school will use other resources, partnerships, and 53 collaborations to aid directly or indirectly in activities critical to 54 the commercialization of research. Insofar as practicable, such matching 55 funds should not consist of direct state grants from the department or 56 from another state agency or state public authority, provided that noth-S. 8549 5 1 ing in this subdivision shall be deemed to prohibit a medical school of 2 the State University of New York which has been designated as a center 3 from using a portion of its operating funds as matching funds. 4 5. Additional plans and programs: other plans and programs integral to 5 the successful execution of the project, including but not limited to 6 patent and intellectual property plans, training and educational 7 programs, and educational integration with research and clinical activ- 8 ities. 9 6. Community support: a demonstration of community support from busi- 10 ness and government leaders and organizations. 11 7. Best practices: a demonstration that the medical school has or will 12 adopt best practices and use of multi-year metrics for performance, and 13 that it will report data as requested or required to the department and 14 the state initiative committee. 15 8. Performance metrics: anticipated annual and cumulative outcomes of 16 the project in terms of direct, indirect, and retained jobs, investment, 17 and economic and other activity, stated in a specific and measurable 18 way, and research findings and progress. 19 9. Advisory council: an advisory council of five members or more that 20 includes one or more executive officers of firms that have been created 21 from research at the school, and individuals with expertise in areas 22 appropriate to the specific developmental sector or concentration of 23 clients, or to biomedical and biotechnological research and development, 24 and to the mission and goal of the project. 25 § 455. Review and approval of applications. Review of applications 26 shall take place as follows: 27 1. The commissioner shall review applications and plans received for 28 completeness, and then forward them to the peer review committee. No 29 plan shall be approved by the state initiative committee that has 30 received a designation of not recommended for further consideration 31 (NRFC) by the peer review committee. No plans shall be forwarded by the 32 commissioner to either committee that require that funds made available 33 pursuant to this article shall be directly or indirectly utilized for 34 research involving human reproductive cloning. 35 2. The members of the peer review committee shall be selected by the 36 chair and the co-chair of the state initiative committee using guide- 37 lines approved by such committee, which shall include requirements 38 concerning expertise and avoidance of conflict of interest. If necessary 39 and deemed appropriate by the state initiative committee, plans may be 40 submitted blind to the peer review panel. Peer review panels shall 41 include a minimum of five members. 42 3. The peer review committee shall review and score plans based on the 43 following criteria: 44 (a) scientific and technical merit; 45 (b) the level of scientific knowledge, technical capability, and/or 46 clinical practice and other necessary plan components that would be 47 required to be housed at the medical school, including improvements that 48 may be anticipated based on the plan; 49 (c) the suitability of principal investigations, collaborators, and 50 other researchers to the project, including the experience and training 51 of staff and collaborators; 52 (d) the ongoing record of accomplishments and integrated expertise at 53 the school or as proposed in the plan, including leadership approach, 54 governance and organizational structure; 55 (e) plans for protection of human subjects; 56 (f) the scientific environment in which the work will be done;S. 8549 6 1 (g) appropriateness of institutional support, equipment, and other 2 physical resources; and 3 (h) such other information as the state initiative committee shall 4 require. 5 4. An application receiving a low score by the peer review committee 6 based on the criteria in subdivision three of this section, or which 7 lacks significant and substantial merit, or which presents in the view 8 of the peer review committee serious ethical problems in the protection 9 of human subjects from research risks, or other serious ethical prob- 10 lems, shall be designated not recommended for further consideration 11 (NRFC). Such plans shall be returned to the commissioner and by the 12 commissioner to the state initiative committee with written recommenda- 13 tions for change. 14 5. The state initiative committee shall review and score plans based 15 on the categories required in the application pursuant to section four 16 hundred fifty-four of this article, and shall additionally consider the 17 following: 18 (a) the anticipated effectiveness of the plan as evidenced by the 19 existence of available resources dedicated to the plan and the commit- 20 ment of the medical school; 21 (b) the ability of the applicant to undertake and complete the plan, 22 the feasibility of meeting the metrics and goals provided for determin- 23 ing the success of the plan, the durability and extent of the relation- 24 ships with incubators and hotspots, and with START-UP NY projects, and 25 with private and other public collaborators; 26 (c) the ability of the applicant to provide the necessary data for an 27 effective evaluation of the project; 28 (d) the amount of federal and private grants, or other resources that 29 will be incentivized and made available to the school to assist in fund- 30 ing of the project; and 31 (e) such other measurable criteria as shall be determined by the 32 committee. 33 6. Plans designated as not recommended for further consideration 34 (NRFC) by the peer review committee or the state initiative committee 35 shall be returned to the applicant with any recommendations for amend- 36 ment and may be resubmitted in the following year. 37 7. The state initiative committee shall review the applications and 38 plans submitted to it and recommend changes and determine funding levels 39 and sources to be included in the unified contract, provided that not 40 more than forty percent of funds, appropriated pursuant to this article 41 shall be used for any single project in any year. Insofar as practicable 42 in approving applications, the committee shall seek to provide a 43 geographically balanced distribution among the regions of the state in 44 designating New York state biomedical and biotechnological translational 45 research and entrepreneurship initiative centers. 46 8. As soon as practicable after approving an application the committee 47 shall notify the temporary president of the senate and the speaker of 48 the assembly of its approval. Such notification shall identify the 49 recipient and state the proposed location, the estimated project funding 50 and award and provide a brief description of the project. 51 § 456. Waiver in certain cases. To promote innovative approaches and 52 maximize effective use of public monies and the likelihood of success in 53 operation of approved New York state biomedical and biotechnological 54 translational research and entrepreneurship initiative centers, and 55 notwithstanding any other provision of law, the commissioner or director 56 of any state agency that is a member of the state initiative committeeS. 8549 7 1 may waive, upon application by such center and subject to the approval 2 of the state initiative committee and the director of the budget, any of 3 such agency's regulatory or procedural requirements that may impede the 4 successful implementation of a project undertaken by the center, 5 provided that such waiver is consistent with applicable state and feder- 6 al statutes and will not impair the general health or welfare of the 7 people receiving services under such project or others. Such commission- 8 er or director shall be authorized, in consultation with the director of 9 the budget, to impose appropriate alternative standards in place of any 10 waived requirements. 11 § 457. Operation and re-designation of New York state biomedical and 12 biotechnological translational research and entrepreneurship initiative 13 centers. In addition to any other requirements of this article, a center 14 will agree to provide data showing its success in meeting project plan 15 goals, including year by year comparison of research activity and 16 commercialization thereof, firm financing and equity capital raised, 17 provided or leveraged from all sources, personnel employed on the 18 project, and jobs created by and through the project. The department 19 shall design simplified forms to aid in the submission of such data, 20 which may be submitted electronically. 21 The chairs of the state initiative committee shall evaluate and report 22 on the operations of the center using methods including but not limited 23 to site visits, reports pursuant to specific information, and review 24 evaluations. If the chairs determine the project is not progressing as 25 agreed, the center will be notified of deficiencies and the center shall 26 remedy any deficiencies in its operations in a timely manner. Such eval- 27 uations shall take place no less than once every three years or more 28 often for any individual center at the discretion of the chairs, and 29 shall result in a written report that includes programmatic and fiscal 30 evaluation of the project and recommendations for improvement. 31 Failure to timely cure a deficiency after review shall result in 32 disqualification of the medical school as a center. 33 A center shall be deemed re-designated upon application every five 34 years unless it shall receive a negative evaluation from the peer review 35 group on its application for re-designation, or if it shall fail to 36 remedy identified defects in its operation made known to it pursuant to 37 this section, or if the state initiative committee determines that such 38 defects are of such a nature, involve fraud, or are of such extent that 39 they cannot be remedied. 40 § 458. Scientific research and discovery bank program. The scientific 41 research and discovery bank program is hereby created, whose purpose 42 shall be to provide funds to centers for recruitment of out of state and 43 retention of in-state scientists and researchers necessary to the 44 successful implementation of approved projects. Monies shall be made 45 available to centers from funds appropriated for the purposes of this 46 article, after review and upon approval by the state initiative commit- 47 tee pursuant to a plan submitted by a center. Such plan may be submitted 48 at the time of the application or at any time during the implementation 49 of the multi-year approved plan and must demonstrate to the satisfaction 50 of the committee that the center has or will have during the period of 51 the grant a match of two dollars for every state dollar provided pursu- 52 ant to this section. Plans must show the timeline and usage of funds 53 required and such other information as the committee shall require, 54 including: the need for such funds and the manner in which such award 55 would enhance the research capabilities of the center necessary to 56 successful implementation of the project plan; the ability of theS. 8549 8 1 researcher to leverage and attract federal funds, venture capital and 2 private industry funds; and the willingness of such researcher to pursue 3 entrepreneurial enterprises resulting in new business or the expansion 4 of existing business in this state. The committee shall establish a 5 schedule for payment of the award. Funds provided pursuant to this 6 section must be applied directly to necessary expenses for recruitment 7 and retention of scientists and researchers, and may not be used for 8 indirect or other overhead costs of the medical school. Insofar as prac- 9 ticable, such matching funds should not consist of direct state grants 10 from the department or from another state agency or state public author- 11 ity, provided that nothing in this section shall be deemed to prohibit a 12 medical school of the State University of New York which has been desig- 13 nated as a center from using a portion of its operating funds as match- 14 ing funds. Funds used for match may include reasonable administrative 15 costs associated with out of state recruitment or in-state retention. 16 § 459. Unified contract. The commissioner on behalf of the state 17 initiative committee shall enter into a unified contract with each 18 center. The provisions of such contract shall include, but not be limit- 19 ed to: a description of project services and activities; the plan; 20 allowable project costs; specific sources of funds that will support the 21 approved costs, including governmental and non-governmental funds or 22 revenues that are proposed to be used in support of project costs; and 23 the allocation of costs by funding source. The form of such unified 24 contract shall be developed in consultation with the division of the 25 budget and the office of state comptroller. The comptroller is author- 26 ized pursuant to a certificate of allocation submitted by the division 27 of the budget to interchange or transfer from appropriations made to the 28 agencies of the committee or any other appropriation, as appropriate, 29 such amounts as may be required to fulfill the obligations of the state 30 pursuant to such unified contracts for payments of such obligations. The 31 division of the budget shall provide the chairs of the senate finance 32 committee and the assembly ways and means committee with quarterly 33 reports of all interchanges and transfers which occur pursuant to this 34 subdivision. 35 1. Allowable costs for a project shall include, but not be limited to 36 costs reasonably incurred for: 37 (a) preparation of the plan; 38 (b) activities as approved in the project application; 39 (c) evaluation of the approved project; and 40 (d) renovations to existing structures as may be needed in furtherance 41 of the plan, except that in no case shall the state support of such 42 costs exceed either twenty-five percent of the amount to be provided 43 pursuant to the contract or fifty percent of the total renovation costs, 44 whichever is less. 45 2. Funding made available pursuant to this article shall not be used 46 to supplant other funds for operations or projects of a center. 47 In addition to the foregoing requirements, a center shall agree to 48 dedicate all funds from any support received pursuant to this article, 49 except for funds received pursuant to paragraph (d) of subdivision one 50 of this section, to operations of the center without deductions for 51 overhead, indirect costs, or facilities and administration charges of 52 the medical school, and to limit to ten percent or less the allocation 53 of funds received through this article to administrative costs of the 54 center. 55 § 3. This act shall take effect on the first of September next 56 succeeding the date on which it shall have become a law.
