Relates to the New York state biomedical and biotechnological translational research and entrepreneurship initiative.
TITLE OF BILL: An act to amend the economic development law, in relation to the New York state biomedical and biotechnological translational research and entrepreneurship initiative
PURPOSE: To rapidly increase biomedical and biotechnological jobs, companies, and enhance research by creating a lab to market program at public and private medical schools in NYS while also ensuring NYS medical schools can maintain and recruit top tier researchers and scientists who are critical to this development as other States make significant investments into recruiting of star talent.
SUMMARY OF PROVISIONS: Amends the economic development law to add a new article 22, the New York state biomedical and biotechnological translational research and entrepreneurship initiative. key provisions:
* State Initiative Committee - composed of several state commissioners, chaired by Commissioners of Economic Development and Health, this provides oversight to the program and designation of the centers.
* Peer review Committee - selected by the chairs of the state Initiative Committee to do qualitative review of applications. This committee does the first review of applications before they are submitted to the State Initiative Committee. The State Committee cannot approve an application that is not recommended by the Peer Review Committee.
* Application - Only a medical school can apply for designation as a NYS biomedical and biotechnological translational research and entrepreneurship initiative center (Center) in response to an RFP. Applications must show 2SCRIPT funding match and demonstrate a majority of the following:
- Commercialization - how the school will increase commercialization of research.
- Commitment five year plan showing use of resources and personnel.
- Resources: the school has or is developing facilities, expertise, and collaborations.
- Collaborations: entrepreneurial relationships with incubators, hotspots, and STARTUP-NY programs, and research collaborations.
- Additional: plans for IP, training and educational programs, integration with research and clinical activities. Also: community support, performance metrics, economic outcomes.
* Review and approval - two-stage review:
- Peer review committee scores qualitative factors: (a) scientific and technical merit; (b) scientific knowledge, technical capability, clinical practice, other components needed to implement the plan; (c) suitability of staff and collaborators; (d) school accomplishments and
expertise; (e) plans for protection of human subjects; (f) the scientific environment; (g) appropriateness of institutional support, equipment, and physical resources; and (h) other information as required. Applications may be not recommended based on low score, or as lacking significant and substantial merit, or as presenting serious ethical problems in the protection of human subjects from research risks, or other serious ethical problems.
- State initiative committee (unless peer review is negative) recommends changes and funding levels and sources. Not more than 40% of funds can be used for any single project in any year. The committee is required to seek geographical balance The committee is also required to notify the legislature of its choices.
* Operation and re-designation. Requires evaluation of centers. Failure to timely cure a deficiency results in disqualification. Centers re-designated every five years unless they receive negative evaluation from the peer review committee, or fail to remedy operational defects, or if the state initiative committee determines that such defects involve fraud, or are of such extent that they cannot be remedied.
* Waiver - allows waiver by State committee member with approval by the rest of the committee and DOB, of regulatory or procedural requirements that impede project success, if the waiver is consistent with statutes and will not impair the general health or welfare. Appropriate alternative standards may be set in place of any waived requirements.
* Scientific research and discovery bank program - centers can request funds for recruitment and retention of out of state and retention of in-state scientists and researchers necessary to projects. Funds must be matched 2:1, and plan must be approved by the State Committee.
* Unified contract. The commissioner of economic development executes a unified contract with each center that includes all information and requirements relative to the project. Limits administrative overhead of the project to 10% and prohibits indirect charges.
EXISTING LAW: New bill.
JUSTIFICATION: New York State can significantly expand high-impact, high-value biomedical and bioscience jobs, development, and innovation by supporting research and entrepreneurship in the state's sixteen public and private medical school centers. Extraordinary research is taking place at the medical schools, but researchers need assistance in developing entrepreneurial skills and business knowledge, along with access to sophisticated financial and intellectual property expertise, to commercialize and bring their inventions to market.
Additionally, NYS must be proactive and provide support to maintain the critical research infrastructure that has been created and developed over time. As federal research dollars, and the opportunities they create, become increasingly scarce, states are recognizing the value provided by especially productive researchers and the potential innovation that can result from their work as an important asset. A number of states such as Texas and California are
investing heavily in the active recruitment of top researchers and scientists, often seeking to pull these individuals and their research enterprises out of the many top-tier New York institutions. New York's medical schools are responsible for $416.5 million in research funding upstate, and $1.8 billion downstate, including $253 million in National Science Foundation awards and $2 billion from the National Institutes of Health. Additionally, New York is home to seven Clinical and Translational Science Awards (CTSA) centers. As impressive as this is, it also leaves the schools vulnerable to downturns and changes. As an example, the Associated Medical Schools of New York expects federal sequestration to result in nearly 1,000 fewer National Science Foundation grant awards, affecting the research programs and education of 12,000 scientists and students NIH, which has already lost one-fifth of its purchasing power over the last decade, will be forced to cut $1.5 billion in awards to research institutions in the first year alone. Each award is estimated to equate to seven research positions. The scientific research and discovery bank program will help New York protect and grow this valuable asset so we are able to keep cutting-edge research in New York and protect the pipeline leading to commercialization in the biomedical and biotechnological sectors.
A potentially fertile alternate source of revenues for the schools that also benefits the residents of this state is more rapid licensure of inventions and techniques developed in medical school center research laboratories. Licensure generates revenue for the schools and the researchers, and also creates jobs and development and potential health care benefits for New Yorkers. Current conversion of research into licensure dollars is low: NYU gets about 50 cents for every research dollar, and Columbia gets about 24 cents. The University of Rochester gets about 9 cents, and Mt. Sinai about 5 cents. Most medical school centers have a low return on investment from research funds. The four just mentioned are all among the top 25 schools in the country for turning research into licensing revenue. Other states and other schools fare much worse.
Creating an entrepreneurial culture can be done by bringing existing NYS infrastructural and economic development program components into collaborative partnership with the schools. This could be done using NYS Business Incubators, Hotspots, and Startup-NY tax free zones, along with some new program approaches. Such a program combines the strengths of medical schools and NYS incubators with strategic State support, to leverage other-source funds in a way that will speed commercialization of research, incentivize public-private partnerships, and increase the depth of the research community. The ultimate program will be similar to the Naomi Berrie Diabetes Center program at Columbia University Medical Center, which uses research, clinical outreach, education, and entrepreneurship as key components.
FISCAL IMPLICATIONS: Subject to appropriation.
EFFECTIVE DATE: September 1 after it becomes law.
STATE OF NEW YORK ________________________________________________________________________ 6555--A IN SENATE February 5, 2014 ___________Introduced by Sens. GOLDEN, GALLIVAN, GRIFFO, HANNON, RANZENHOFER, ROBACH, TKACZYK, VALESKY -- read twice and ordered printed, and when printed to be committed to the Committee on Commerce, Economic Devel- opment and Small Business -- committee discharged, bill amended, ordered reprinted as amended and recommitted to said committee 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: 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 well- being of New Yorkers and potentially reduce health care costs. The legislature further finds that although New York state's biomedi- cal 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 signif- icant 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 poten- tial 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 biomedicalEXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD13390-05-4 S. 6555--A 2
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, royalties, and licensure, and leverage significant partnerships with public and private entities; enhance our scientific and research capa- bilities; 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. S 2. The economic development law is amended by adding a new article 22 to read as follows: ARTICLE 22 THE NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE SECTION 441. SHORT TITLE. 442. DEFINITIONS. 443. NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATION- AL RESEARCH AND ENTREPRENEURSHIP INITIATIVE COMMITTEE. 444. APPLICATION FOR DESIGNATION AS A NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTRE- PRENEURSHIP INITIATIVE CENTER. 445. REVIEW AND APPROVAL OF APPLICATIONS. 446. WAIVER IN CERTAIN CASES. 447. OPERATION AND RE-DESIGNATION OF NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTRE- PRENEURSHIP INITIATIVE CENTERS. 448. SCIENTIFIC RESEARCH AND DISCOVERY BANK PROGRAM. 449. UNIFIED CONTRACT. S 441. SHORT TITLE. THIS ARTICLE SHALL BE KNOWN AND MAY BE CITED AS THE "NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE". S 442. DEFINITIONS. AS USED IN THIS ARTICLE: 1. "MEDICAL SCHOOL" MEANS A PUBLIC OR PRIVATE MEDICAL SCHOOL ACCRED- ITED BY THE LIAISON COMMITTEE ON MEDICAL EDUCATION OR THE COMMISSION ON OSTEOPATHIC COLLEGE ACCREDITATION, OR SUCH MEDICAL SCHOOL AND AN AFFIL- IATED 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 BIOTECH- NOLOGICAL RESEARCH. 4. "PLAN" MEANS THE MULTI-YEAR PLAN THAT ACCOMPANIES THE APPLICATION OF A MEDICAL SCHOOL TO BECOME A NEW YORK STATE BIOMEDICAL AND BIOTECHNO- LOGICAL 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 ENTREPRENEUR- SHIP INITIATIVE CENTER. 6. "START-UP NY" PROGRAM MEANS THE START-UP PROGRAM AUTHORIZED PURSU- ANT 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.S. 6555--A 3
7. "STATE INITIATIVE COMMITTEE" OR "STATE COMMITTEE" MEANS THE BIOMED- ICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE COMMITTEE CREATED BY SECTION FOUR HUNDRED FORTY-THREE OF THIS ARTICLE. 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. S 443. NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE COMMITTEE. THE NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEUR- SHIP INITIATIVE COMMITTEE IS HEREBY CREATED, TO CONSIST OF THE COMMIS- SIONERS 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 DIVI- SION 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 DESIG- NEES 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 TRAN- SITIONAL 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 FORTY-SEVEN OF THIS ARTICLE. (D) ESTABLISH A UNIFIED CONTRACT FOR PROJECTS PURSUANT TO SECTION FOUR HUNDRED FORTY-NINE OF THIS ARTICLE. (E) RECEIVE AND REVIEW PERFORMANCE METRICS REPORTS FROM CENTERS. (F) RE-DESIGNATE THE CENTERS EVERY FIVE YEARS PURSUANT TO THIS ARTI- CLE. (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 ACTIV- ITIES 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 SCIEN- TISTS 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 IMPED- IMENTS TO SUCCESSFUL IMPLEMENTATION OF APPROVED PLANS, AND AS NECESSARY,S. 6555--A 4
SUBMIT REQUESTS TO THE LEGISLATURE IN ACCORDANCE WITH ARTICLE VII OF THE STATE CONSTITUTION FOR SPECIFIC LEGISLATIVE ENACTMENTS NECESSARY TO REMOVE SUCH IMPEDIMENTS. (K) ENTER INTO AGREEMENTS BETWEEN AND AMONG THE MEMBERS OF THE COMMIT- TEE AS NECESSARY TO DELINEATE THEIR RESPECTIVE ROLES REGARDING THE COOP- ERATIVE PROVISION OF FUNDING AND ASSISTANCE. 2. THE COMMITTEE MAY ACT THROUGH ITS CHAIRS IN ALL MATTERS OF OVER- SIGHT AND IMPLEMENTATION OF THE PROGRAM AUTHORIZED BY THIS ARTICLE. S 444. 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 DESIG- NATION AS A NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE CENTER BY SUBMITTING AN APPLI- CATION AND PLAN TO THE COMMISSIONER. THE COMMISSIONER SHALL FORWARD ALL SUCH APPLICATIONS TO THE PEER REVIEW COMMITTEE FOR REVIEW AND RECOMMEN- DATION 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 UNDER- TAKEN 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, ENTRE- PRENEURSHIP, 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 MANAGE- MENT 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 LIMIT- ED 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 TOS. 6555--A 5
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- 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 ACTIV- ITIES. 6. COMMUNITY SUPPORT: A DEMONSTRATION OF COMMUNITY SUPPORT FROM BUSI- NESS 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. 8. PERFORMANCE METRICS: ANTICIPATED ANNUAL AND CUMULATIVE OUTCOMES OF THE PROJECT IN TERMS OF DIRECT, INDIRECT, AND RETAINED JOBS, INVESTMENT, AND ECONOMIC AND OTHER ACTIVITY, STATED IN A SPECIFIC AND MEASURABLE WAY, AND RESEARCH FINDINGS AND PROGRESS. 9. ADVISORY COUNCIL: AN ADVISORY COUNCIL OF FIVE MEMBERS OR MORE THAT INCLUDES ONE OR MORE EXECUTIVE OFFICERS OF FIRMS THAT HAVE BEEN CREATED FROM RESEARCH AT THE SCHOOL, AND INDIVIDUALS WITH EXPERTISE IN AREAS APPROPRIATE TO THE SPECIFIC DEVELOPMENTAL SECTOR OR CONCENTRATION OF CLIENTS, OR TO BIOMEDICAL AND BIOTECHNOLOGICAL RESEARCH AND DEVELOPMENT, AND TO THE MISSION AND GOAL OF THE PROJECT. S 445. REVIEW AND APPROVAL OF APPLICATIONS. REVIEW OF APPLICATIONS SHALL TAKE PLACE AS FOLLOWS: 1. THE COMMISSIONER SHALL REVIEW APPLICATIONS AND PLANS RECEIVED FOR COMPLETENESS, AND THEN FORWARD THEM TO THE PEER REVIEW COMMITTEE. NO PLAN SHALL BE APPROVED BY THE STATE INITIATIVE COMMITTEE THAT HAS RECEIVED A DESIGNATION OF NOT RECOMMENDED FOR FURTHER CONSIDERATION (NRFC) BY THE PEER REVIEW COMMITTEE. NO PLANS SHALL BE FORWARDED BY THE COMMISSIONER TO EITHER COMMITTEE THAT REQUIRE THAT FUNDS MADE AVAILABLE PURSUANT TO THIS ARTICLE SHALL BE DIRECTLY OR INDIRECTLY UTILIZED FOR RESEARCH INVOLVING HUMAN REPRODUCTIVE CLONING. 2. THE MEMBERS OF THE PEER REVIEW COMMITTEE SHALL BE SELECTED BY THE CHAIR AND THE CO-CHAIR OF THE STATE INITIATIVE COMMITTEE USING GUIDE- LINES APPROVED BY SUCH COMMITTEE, WHICH SHALL INCLUDE REQUIREMENTS CONCERNING EXPERTISE AND AVOIDANCE OF CONFLICT OF INTEREST. IF NECESSARY AND DEEMED APPROPRIATE BY THE STATE INITIATIVE COMMITTEE, PLANS MAY BE SUBMITTED BLIND TO THE PEER REVIEW PANEL. PEER REVIEW PANELS SHALL INCLUDE A MINIMUM OF FIVE MEMBERS. 3. THE PEER REVIEW COMMITTEE SHALL REVIEW AND SCORE PLANS BASED ON THE FOLLOWING CRITERIA: (A) SCIENTIFIC AND TECHNICAL MERIT; (B) THE LEVEL OF SCIENTIFIC KNOWLEDGE, TECHNICAL CAPABILITY, AND/OR CLINICAL PRACTICE AND OTHER NECESSARY PLAN COMPONENTS THAT WOULD BE REQUIRED TO BE HOUSED AT THE MEDICAL SCHOOL, INCLUDING IMPROVEMENTS THAT MAY BE ANTICIPATED BASED ON THE PLAN; (C) THE SUITABILITY OF PRINCIPAL INVESTIGATIONS, COLLABORATORS, AND OTHER RESEARCHERS TO THE PROJECT, INCLUDING THE EXPERIENCE AND TRAINING OF STAFF AND COLLABORATORS;S. 6555--A 6
(D) THE ONGOING RECORD OF ACCOMPLISHMENTS AND INTEGRATED EXPERTISE AT THE SCHOOL OR AS PROPOSED IN THE PLAN, INCLUDING LEADERSHIP APPROACH, GOVERNANCE AND ORGANIZATIONAL STRUCTURE; (E) PLANS FOR PROTECTION OF HUMAN SUBJECTS; (F) THE SCIENTIFIC ENVIRONMENT IN WHICH THE WORK WILL BE DONE; (G) APPROPRIATENESS OF INSTITUTIONAL SUPPORT, EQUIPMENT, AND OTHER PHYSICAL RESOURCES; AND (H) SUCH OTHER INFORMATION AS THE STATE INITIATIVE COMMITTEE SHALL REQUIRE. 4. AN APPLICATION RECEIVING A LOW SCORE BY THE PEER REVIEW COMMITTEE BASED ON THE CRITERIA IN SUBDIVISION THREE OF THIS SECTION, OR WHICH LACKS SIGNIFICANT AND SUBSTANTIAL MERIT, OR WHICH PRESENTS IN THE VIEW OF THE PEER REVIEW COMMITTEE SERIOUS ETHICAL PROBLEMS IN THE PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISKS, OR OTHER SERIOUS ETHICAL PROB- LEMS, SHALL BE DESIGNATED NOT RECOMMENDED FOR FURTHER CONSIDERATION (NRFC). SUCH PLANS SHALL BE RETURNED TO THE COMMISSIONER AND BY THE COMMISSIONER TO THE STATE INITIATIVE COMMITTEE WITH WRITTEN RECOMMENDA- TIONS FOR CHANGE. 5. THE STATE INITIATIVE COMMITTEE SHALL REVIEW AND SCORE PLANS BASED ON THE CATEGORIES REQUIRED IN THE APPLICATION PURSUANT TO SECTION FOUR HUNDRED FORTY-FOUR OF THIS ARTICLE, AND SHALL ADDITIONALLY CONSIDER THE FOLLOWING: (A) THE ANTICIPATED EFFECTIVENESS OF THE PLAN AS EVIDENCED BY THE EXISTENCE OF AVAILABLE RESOURCES DEDICATED TO THE PLAN AND THE COMMIT- MENT OF THE MEDICAL SCHOOL; (B) THE ABILITY OF THE APPLICANT TO UNDERTAKE AND COMPLETE THE PLAN, THE FEASIBILITY OF MEETING THE METRICS AND GOALS PROVIDED FOR DETERMIN- ING THE SUCCESS OF THE PLAN, THE DURABILITY AND EXTENT OF THE RELATION- SHIPS WITH INCUBATORS AND HOTSPOTS, AND WITH START-UP NY PROJECTS, AND WITH PRIVATE AND OTHER PUBLIC COLLABORATORS; (C) THE ABILITY OF THE APPLICANT TO PROVIDE THE NECESSARY DATA FOR AN EFFECTIVE EVALUATION OF THE PROJECT; (D) THE AMOUNT OF FEDERAL AND PRIVATE GRANTS, OR OTHER RESOURCES THAT WILL BE INCENTIVIZED AND MADE AVAILABLE TO THE SCHOOL TO ASSIST IN FUND- ING OF THE PROJECT; AND (E) SUCH OTHER MEASURABLE CRITERIA AS SHALL BE DETERMINED BY THE COMMITTEE. 6. PLANS DESIGNATED AS NOT RECOMMENDED FOR FURTHER CONSIDERATION (NRFC) BY THE PEER REVIEW COMMITTEE OR THE STATE INITIATIVE COMMITTEE SHALL BE RETURNED TO THE APPLICANT WITH ANY RECOMMENDATIONS FOR AMEND- MENT AND MAY BE RESUBMITTED IN THE FOLLOWING YEAR. 7. THE STATE INITIATIVE COMMITTEE SHALL REVIEW THE APPLICATIONS AND PLANS SUBMITTED TO IT AND RECOMMEND CHANGES AND DETERMINE FUNDING LEVELS AND SOURCES TO BE INCLUDED IN THE UNIFIED CONTRACT, PROVIDED THAT NOT MORE THAN FORTY PERCENT OF FUNDS, APPROPRIATED PURSUANT TO THIS ARTICLE SHALL BE USED FOR ANY SINGLE PROJECT IN ANY YEAR. INSOFAR AS PRACTICABLE IN APPROVING APPLICATIONS, THE COMMITTEE SHALL SEEK TO PROVIDE A GEOGRAPHICALLY BALANCED DISTRIBUTION AMONG THE REGIONS OF THE STATE IN DESIGNATING NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE CENTERS. 8. AS SOON AS PRACTICABLE AFTER APPROVING AN APPLICATION THE COMMITTEE SHALL NOTIFY THE TEMPORARY PRESIDENT OF THE SENATE AND THE SPEAKER OF THE ASSEMBLY OF ITS APPROVAL. SUCH NOTIFICATION SHALL IDENTIFY THE RECIPIENT AND STATE THE PROPOSED LOCATION, THE ESTIMATED PROJECT FUNDING AND AWARD AND PROVIDE A BRIEF DESCRIPTION OF THE PROJECT.S. 6555--A 7
S 446. WAIVER IN CERTAIN CASES. TO PROMOTE INNOVATIVE APPROACHES AND MAXIMIZE EFFECTIVE USE OF PUBLIC MONIES AND THE LIKELIHOOD OF SUCCESS IN OPERATION OF APPROVED NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE CENTERS, AND NOTWITHSTANDING ANY OTHER PROVISION OF LAW, THE COMMISSIONER OR DIRECTOR OF ANY STATE AGENCY THAT IS A MEMBER OF THE STATE INITIATIVE COMMITTEE MAY WAIVE, UPON APPLICATION BY SUCH CENTER AND SUBJECT TO THE APPROVAL OF THE STATE INITIATIVE COMMITTEE AND THE DIRECTOR OF THE BUDGET, ANY OF SUCH AGENCY'S REGULATORY OR PROCEDURAL REQUIREMENTS THAT MAY IMPEDE THE SUCCESSFUL IMPLEMENTATION OF A PROJECT UNDERTAKEN BY THE CENTER, PROVIDED THAT SUCH WAIVER IS CONSISTENT WITH APPLICABLE STATE AND FEDER- AL STATUTES AND WILL NOT IMPAIR THE GENERAL HEALTH OR WELFARE OF THE PEOPLE RECEIVING SERVICES UNDER SUCH PROJECT OR OTHERS. SUCH COMMISSION- ER OR DIRECTOR SHALL BE AUTHORIZED, IN CONSULTATION WITH THE DIRECTOR OF THE BUDGET, TO IMPOSE APPROPRIATE ALTERNATIVE STANDARDS IN PLACE OF ANY WAIVED REQUIREMENTS. S 447. OPERATION AND RE-DESIGNATION OF NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE CENTERS. IN ADDITION TO ANY OTHER REQUIREMENTS OF THIS ARTICLE, A CENTER WILL AGREE TO PROVIDE DATA SHOWING ITS SUCCESS IN MEETING PROJECT PLAN GOALS, INCLUDING YEAR BY YEAR COMPARISON OF RESEARCH ACTIVITY AND COMMERCIALIZATION THEREOF, FIRM FINANCING AND EQUITY CAPITAL RAISED, PROVIDED OR LEVERAGED FROM ALL SOURCES, PERSONNEL EMPLOYED ON THE PROJECT, AND JOBS CREATED BY AND THROUGH THE PROJECT. THE DEPARTMENT SHALL DESIGN SIMPLIFIED FORMS TO AID IN THE SUBMISSION OF SUCH DATA, WHICH MAY BE SUBMITTED ELECTRONICALLY. THE CHAIRS OF THE STATE INITIATIVE COMMITTEE SHALL EVALUATE AND REPORT ON THE OPERATIONS OF THE CENTER USING METHODS INCLUDING BUT NOT LIMITED TO SITE VISITS, REPORTS PURSUANT TO SPECIFIC INFORMATION, AND REVIEW EVALUATIONS. IF THE CHAIRS DETERMINE THE PROJECT IS NOT PROGRESSING AS AGREED, THE CENTER WILL BE NOTIFIED OF DEFICIENCIES AND THE CENTER SHALL REMEDY ANY DEFICIENCIES IN ITS OPERATIONS IN A TIMELY MANNER. SUCH EVAL- UATIONS SHALL TAKE PLACE NO LESS THAN ONCE EVERY THREE YEARS OR MORE OFTEN FOR ANY INDIVIDUAL CENTER AT THE DISCRETION OF THE CHAIRS, AND SHALL RESULT IN A WRITTEN REPORT THAT INCLUDES PROGRAMMATIC AND FISCAL EVALUATION OF THE PROJECT AND RECOMMENDATIONS FOR IMPROVEMENT. FAILURE TO TIMELY CURE A DEFICIENCY AFTER REVIEW SHALL RESULT IN DISQUALIFICATION OF THE MEDICAL SCHOOL AS A CENTER. A CENTER SHALL BE DEEMED RE-DESIGNATED UPON APPLICATION EVERY FIVE YEARS UNLESS IT SHALL RECEIVE A NEGATIVE EVALUATION FROM THE PEER REVIEW GROUP ON ITS APPLICATION FOR RE-DESIGNATION, OR IF IT SHALL FAIL TO REMEDY IDENTIFIED DEFECTS IN ITS OPERATION MADE KNOWN TO IT PURSUANT TO THIS SECTION, OR IF THE STATE INITIATIVE COMMITTEE DETERMINES THAT SUCH DEFECTS ARE OF SUCH A NATURE, INVOLVE FRAUD, OR ARE OF SUCH EXTENT THAT THEY CANNOT BE REMEDIED. S 448. SCIENTIFIC RESEARCH AND DISCOVERY BANK PROGRAM. THE SCIENTIFIC RESEARCH AND DISCOVERY BANK PROGRAM IS HEREBY CREATED, WHOSE PURPOSE SHALL BE TO PROVIDE FUNDS TO CENTERS FOR RECRUITMENT OF OUT OF STATE AND RETENTION OF IN-STATE SCIENTISTS AND RESEARCHERS NECESSARY TO THE SUCCESSFUL IMPLEMENTATION OF APPROVED PROJECTS. MONIES SHALL BE MADE AVAILABLE TO CENTERS FROM FUNDS APPROPRIATED FOR THE PURPOSES OF THIS ARTICLE, AFTER REVIEW AND UPON APPROVAL BY THE STATE INITIATIVE COMMIT- TEE PURSUANT TO A PLAN SUBMITTED BY A CENTER. SUCH PLAN MAY BE SUBMITTED AT THE TIME OF THE APPLICATION OR AT ANY TIME DURING THE IMPLEMENTATION OF THE MULTI-YEAR APPROVED PLAN AND MUST DEMONSTRATE TO THE SATISFACTION OF THE COMMITTEE THAT THE CENTER HAS OR WILL HAVE DURING THE PERIOD OFS. 6555--A 8
THE GRANT A MATCH OF TWO DOLLARS FOR EVERY STATE DOLLAR PROVIDED PURSU- ANT TO THIS SECTION. PLANS MUST SHOW THE TIMELINE AND USAGE OF FUNDS REQUIRED AND SUCH OTHER INFORMATION AS THE COMMITTEE SHALL REQUIRE, INCLUDING: THE NEED FOR SUCH FUNDS AND THE MANNER IN WHICH SUCH AWARD WOULD ENHANCE THE RESEARCH CAPABILITIES OF THE CENTER NECESSARY TO SUCCESSFUL IMPLEMENTATION OF THE PROJECT PLAN; THE ABILITY OF THE RESEARCHER TO LEVERAGE AND ATTRACT FEDERAL FUNDS, VENTURE CAPITAL AND PRIVATE INDUSTRY FUNDS; AND THE WILLINGNESS OF SUCH RESEARCHER TO PURSUE ENTREPRENEURIAL ENTERPRISES RESULTING IN NEW BUSINESS OR THE EXPANSION OF EXISTING BUSINESS IN THIS STATE. THE COMMITTEE SHALL ESTABLISH A SCHEDULE FOR PAYMENT OF THE AWARD. FUNDS PROVIDED PURSUANT TO THIS SECTION MUST BE APPLIED DIRECTLY TO NECESSARY EXPENSES FOR RECRUITMENT AND RETENTION OF SCIENTISTS AND RESEARCHERS, AND MAY NOT BE USED FOR INDIRECT OR OTHER OVERHEAD COSTS OF THE MEDICAL SCHOOL. INSOFAR AS PRAC- TICABLE, SUCH MATCHING FUNDS SHOULD NOT CONSIST OF DIRECT STATE GRANTS FROM THE DEPARTMENT OR FROM ANOTHER STATE AGENCY OR STATE PUBLIC AUTHOR- ITY, PROVIDED THAT NOTHING IN THIS SECTION SHALL BE DEEMED TO PROHIBIT A MEDICAL SCHOOL OF THE STATE UNIVERSITY OF NEW YORK WHICH HAS BEEN DESIG- NATED AS A CENTER FROM USING A PORTION OF ITS OPERATING FUNDS AS MATCH- ING FUNDS. FUNDS USED FOR MATCH MAY INCLUDE REASONABLE ADMINISTRATIVE COSTS ASSOCIATED WITH OUT OF STATE RECRUITMENT OR IN-STATE RETENTION. S 449. UNIFIED CONTRACT. THE COMMISSIONER ON BEHALF OF THE STATE INITIATIVE COMMITTEE SHALL ENTER INTO A UNIFIED CONTRACT WITH EACH CENTER. THE PROVISIONS OF SUCH CONTRACT SHALL INCLUDE, BUT NOT BE LIMIT- ED TO: A DESCRIPTION OF PROJECT SERVICES AND ACTIVITIES; THE PLAN; ALLOWABLE PROJECT COSTS; SPECIFIC SOURCES OF FUNDS THAT WILL SUPPORT THE APPROVED COSTS, INCLUDING GOVERNMENTAL AND NON-GOVERNMENTAL FUNDS OR REVENUES THAT ARE PROPOSED TO BE USED IN SUPPORT OF PROJECT COSTS; AND THE ALLOCATION OF COSTS BY FUNDING SOURCE. THE FORM OF SUCH UNIFIED CONTRACT SHALL BE DEVELOPED IN CONSULTATION WITH THE DIVISION OF THE BUDGET AND THE OFFICE OF STATE COMPTROLLER. THE COMPTROLLER IS AUTHOR- IZED PURSUANT TO A CERTIFICATE OF ALLOCATION SUBMITTED BY THE DIVISION OF THE BUDGET TO INTERCHANGE OR TRANSFER FROM APPROPRIATIONS MADE TO THE AGENCIES OF THE COMMITTEE OR ANY OTHER APPROPRIATION, AS APPROPRIATE, SUCH AMOUNTS AS MAY BE REQUIRED TO FULFILL THE OBLIGATIONS OF THE STATE PURSUANT TO SUCH UNIFIED CONTRACTS FOR PAYMENTS OF SUCH OBLIGATIONS. THE DIVISION OF THE BUDGET SHALL PROVIDE THE CHAIRS OF THE SENATE FINANCE COMMITTEE AND THE ASSEMBLY WAYS AND MEANS COMMITTEE WITH QUARTERLY REPORTS OF ALL INTERCHANGES AND TRANSFERS WHICH OCCUR PURSUANT TO THIS SUBDIVISION. 1. ALLOWABLE COSTS FOR A PROJECT SHALL INCLUDE, BUT NOT BE LIMITED TO COSTS REASONABLY INCURRED FOR: (A) PREPARATION OF THE PLAN; (B) ACTIVITIES AS APPROVED IN THE PROJECT APPLICATION; (C) EVALUATION OF THE APPROVED PROJECT; AND (D) RENOVATIONS TO EXISTING STRUCTURES AS MAY BE NEEDED IN FURTHERANCE OF THE PLAN, EXCEPT THAT IN NO CASE SHALL THE STATE SUPPORT OF SUCH COSTS EXCEED EITHER TWENTY-FIVE PERCENT OF THE AMOUNT TO BE PROVIDED PURSUANT TO THE CONTRACT OR FIFTY PERCENT OF THE TOTAL RENOVATION COSTS, WHICHEVER IS LESS. 2. FUNDING MADE AVAILABLE PURSUANT TO THIS ARTICLE SHALL NOT BE USED TO SUPPLANT OTHER FUNDS FOR OPERATIONS OR PROJECTS OF A CENTER. IN ADDITION TO THE FOREGOING REQUIREMENTS, A CENTER SHALL AGREE TO DEDICATE ALL FUNDS FROM ANY SUPPORT RECEIVED PURSUANT TO THIS ARTICLE, EXCEPT FOR FUNDS RECEIVED PURSUANT TO PARAGRAPH (D) OF SUBDIVISION ONE OF THIS SECTION, TO OPERATIONS OF THE CENTER WITHOUT DEDUCTIONS FORS. 6555--A 9
OVERHEAD, INDIRECT COSTS, OR FACILITIES AND ADMINISTRATION CHARGES OF THE MEDICAL SCHOOL, AND TO LIMIT TO TEN PERCENT OR LESS THE ALLOCATION OF FUNDS RECEIVED THROUGH THIS ARTICLE TO ADMINISTRATIVE COSTS OF THE CENTER. S 3. This act shall take effect on the first of September next succeeding the date on which it shall have become a law.