S T A T E O F N E W Y O R K
________________________________________________________________________
6555
I N S E N A T E
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
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. 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
medical schools, can significantly increase the speed and amount of
commercialization of research from lab to market, maintain the quality
and increase the likelihood of high impact healthcare breakthroughs, and
materially expand economic and job opportunities for all New Yorkers in
this high growth sector.
The legislature further finds that although New York state's biomedi-
cal and biotechnological research infrastructure includes many of the
nation's top institutions, researchers and scientists, and has many
natural advantages compared to other states, it has lagged behind the
nation as a whole and many states in growth in jobs, development, and
economic activity for a decade; and further, that other states are
making investments and developing incentives that are creating rapid
growth in this sector and increasing the gap between New York and other
states, and potential loss of top tier scientific and research talent as
they migrate 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 approaches and statutory precedents to
support and incentivize an effective and integrated plan for development
of biomedical and biotechnological entrepreneurship by and through the
state's medical schools, and declares that the program enacted by this
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD13390-02-3
S. 6555 2
act will expand economic activity and job development, maintain and
attract high quality research, increase resources available to the
schools and researchers from grants, private investments, and licensure,
and leverage significant partnerships with public and private entities,
to 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. ADMINISTRATION.
445. APPLICATION FOR DESIGNATION AS A NEW YORK STATE BIOMEDICAL
AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTRE-
PRENEURSHIP INITIATIVE CENTER.
446. REVIEW AND APPROVAL OF APPLICATIONS.
447. WAIVER IN CERTAIN CASES.
448. OPERATION AND REDESIGNATION OF NEW YORK STATE BIOMEDICAL
AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTRE-
PRENEURSHIP INITIATIVE CENTERS.
449. SCIENTIFIC RESEARCH AND DISCOVERY BANK PROGRAM.
450. UNIFIED CONTRACT.
451. REPORT.
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 SECTION,
1. "MEDICAL SCHOOL" MEANS A PUBLIC OR PRIVATE MEDICAL SCHOOL 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 IN COLLABORATION WITH THE STATE INITIATIVE COMMITTEE,
CONSISTING OF NON-NEW YORK STATE EXPERTS IN THE FIELDS OF BIOMEDICAL AND
BIOTECHNOLOGICAL DEVELOPMENT, INCLUDING RESEARCHERS AND SCIENTISTS, AND
COMPANY REPRESENTATIVES AT THE EXECUTIVE OFFICER LEVEL ENGAGED IN
MAKING, DEVELOPMENT, AND FINANCING 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 BIOTECHNO-
LOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE CENTER.
5. "PROJECT" IS THE EXECUTION OF THE NEW YORK STATE BIOMEDICAL AND
BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE
CENTER PLAN BY THE MEDICAL SCHOOL WHICH HAS BEEN DESIGNATED AS A NEW
YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND
ENTREPRENEURSHIP INITIATIVE CENTER.
6. "START-UP NY" PROGRAM MEANS THE START-UP NY PROGRAM AUTHORIZED
PURSUANT TO ARTICLE TWENTY-ONE OF THIS CHAPTER, AND "TAX-FREE NY AREA"
HAS THE SAME MEANING AS IN ARTICLE TWENTY-ONE OF THIS CHAPTER.
S. 6555 3
7. "STATE INITIATIVE COMMITTEE" MEANS THE BIOMEDICAL AND BIOTECHNOLOG-
ICAL 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 UPON APPROVAL BY THE STATE INITIATIVE COMMITTEE PURSUANT TO THIS
ARTICLE.
9. "UNIFIED CONTRACT" IS THE CONTRACT BETWEEN THE DEPARTMENT AND THE
MEDICAL SCHOOL THAT INCLUDES ALL ITEMS NECESSARY TO THE EXECUTION AND
ADMINISTRATION OF THE NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL
TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE PROJECT AS
DESCRIBED IN THIS ARTICLE, INCLUDING FUNDING, ACTIVITIES, PERFORMANCE
METRICS, DATA SHARING, AND OTHER ITEMS.
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) ACCEPT AND REVIEW APPLICATIONS AND DESIGNATE MEDICAL SCHOOLS AS
NEW YORK STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH
AND ENTREPRENEURSHIP INITIATIVE CENTERS USING THE CRITERIA ESTABLISHED
IN THIS ARTICLE.
(C) ACCEPT REQUESTS FOR AND APPROVE WAIVERS OF REGULATIONS AND PROCE-
DURES AS PROVIDED FOR IN SECTION FOUR HUNDRED FORTY-SIX OF THIS ARTICLE.
(D) ESTABLISH A UNIFIED CONTRACT FOR ADMINISTRATION OF PROJECTS PURSU-
ANT TO SECTION FOUR HUNDRED FIFTY OF THIS ARTICLE.
(E) RECEIVE AND REVIEW REPORTS FROM CENTERS TO ASSURE THAT PERFORMANCE
METRICS OF APPROVED PLANS ARE MET.
(F) REDESIGNATE THE CENTERS EVERY THREE YEARS UNDER THE PROCEDURES
ESTABLISHED PURSUANT TO THIS ARTICLE.
(G) DEVELOP RESOURCES AND PROCEDURES TO AID IN ESTABLISHING A MORE
RAPID PROCESS FOR COMMERCIALIZATION OF RESEARCH AND FUNDING OF ENTREPRE-
NEURIAL EFFORTS CREATED AS A RESULT OF PROJECTS, INCLUDING BUT NOT
LIMITED TO SUCH ACTIVITIES AS PROCUREMENT BY MEMBER AGENCIES OF THE
COMMITTEE OF GOODS OR SERVICES FROM COMPANIES CREATED IN THE PROJECTS;
ENDORSING, COLLABORATING, OR 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 APPLICATION OF THE
RESOURCES OF THE STATE AND ITS AGENCIES TO 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 AND RETENTION OF STAR SCIENTISTS AND RESEARCHERS.
(I) UPON REQUEST, PROVIDE TECHNICAL ASSISTANCE TO APPLICANTS, AND AS
NEEDED FOR A PROJECT, INCLUDING BUT NOT LIMITED TO ASSISTANCE IN IDENTI-
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FYING AND OBTAINING RESOURCES AND FUNDING NECESSARY FOR THE SUCCESSFUL
IMPLEMENTATION OF THE PLAN.
(J) IDENTIFY STATUTORY REQUIREMENTS THAT THE COMMITTEE VIEWS AS IMPED-
IMENTS 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.
(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 PROGRAM FUNDING AND TECHNICAL ASSISTANCE.
(L) REQUIRE SUCH ADDITIONAL REPORTS, INFORMATION, OR OVERSIGHT AS MAY
BE NECESSARY TO THE SUCCESSFUL IMPLEMENTATION OF A PROJECT.
2. THE COMMITTEE MAY ACT THROUGH ITS CHAIRS IN ALL MATTERS OF OVER-
SIGHT AND IMPLEMENTATION OF THE PROGRAM AUTHORIZED BY THIS ARTICLE,
INCLUDING RECEIPT OF APPLICATIONS, NOTIFICATION OF DESIGNATION, AND
MONITORING OF APPROVED CENTERS TO ENSURE THAT SERVICES ARE PROVIDED IN
ACCORDANCE WITH THE APPROVED PLAN AND THAT FUNDS ARE USED IN ACCORDANCE
WITH APPLICABLE STATE AND FEDERAL LAW AND REGULATIONS.
S 444. ADMINISTRATION. EXCEPT WHERE OTHERWISE PRESCRIBED, THE DEPART-
MENT SHALL BE RESPONSIBLE FOR THE ADMINISTRATION OF THE PROVISIONS OF
THIS ARTICLE.
S 445. 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 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 PLANS TO THE PEER REVIEW COMMITTEE
FOR ASSESSMENT AS HEREIN PROVIDED, AND THEN TO THE STATE INITIATIVE
COMMITTEE. IN ADDITION TO SUCH OTHER ITEMS, WARRANTIES, AND INFORMATION
AS THE STATE INITIATIVE COMMITTEE MAY REQUIRE, PLANS MUST SHOW AN INTE-
GRATED VISION FOR COMMERCIALIZING RESEARCH FROM LAB TO MARKETPLACE
INCLUDING AN INTERRELATED DEMONSTRATION OF THE FOLLOWING:
1. COMMITMENT: A MULTI-YEAR COMMITMENT BY THE MEDICAL SCHOOL TO DEVEL-
OPMENT AND IMPLEMENTATION OF THE PLAN, OVER A PERIOD OF NOT LESS THAN
FIVE YEARS, SUCH COMMITMENT TO BE DEMONSTRATED BY A MULTI-YEAR COMMIT-
MENT OF RESOURCES, PERSONNEL, AND FUNDS THAT THE SCHOOL WILL USE,
DIRECTLY OR THROUGH PARTNERSHIPS AND COLLABORATIONS, TO PROVIDE AND/OR
INCENTIVIZE INTEGRATED RESEARCH, EDUCATION, CLINICAL PRACTICE, ENTRE-
PRENEURSHIP, FINANCING, PARTNERSHIPS, AND MORE RAPID COMMERCIALIZATION
OF RESEARCH.
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 EXISTING OPERATIONAL CLINICAL FACILITIES AND EXPER-
TISE OR EVIDENCE OF BONA FIDE COLLABORATIONS AND PARTNERSHIPS THAT CAN
PROVIDE SUCH FACILITIES AND EXPERTISE SUFFICIENT TO SUCCESSFULLY IMPLE-
MENT THE PLAN; A DEMONSTRATION THAT THE PROJECT WILL HAVE A PROFESSIONAL
MANAGEMENT TEAM WITH EXPERIENCE, EXPERTISE, OR CREDENTIALS IN MANAGE-
MENT, 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 INCLUDING
WRITTEN PROTOCOLS OF BONA FIDE RELATIONS WITH ONE OR MORE INCUBATORS AND
HOTSPOTS, FOR PROVISION OF ENTREPRENEURIAL SERVICES TO RESEARCHERS, WITH
A START-UP NY TAX-FREE NY PROGRAM AREA TO PROVIDE LOCATION AND SERVICES
S. 6555 5
AS NEEDED FOR SUCH RESEARCHERS AND ACTIVITIES, AND SUBSTANTIVE COLLAB-
ORATIONS WITH PRIVATE ENTITIES FOR TRAINING, COMMERCIALIZATION, FINANC-
ING, OR OTHER ACTIVITIES INTEGRAL TO THE PLAN.
4. LEVERAGED AND APPLIED FUNDING: A DEMONSTRATION THAT THE SCHOOL HAS
IN HAND OR WILL SHORTLY OBTAIN AND MAINTAIN DURING THE PLAN PERIOD THE
REQUIRED FUNDING MATCH OF AT LEAST TWO NON-STATE DOLLARS FOR EVERY STATE
DOLLAR PROVIDED PURSUANT TO THIS ARTICLE TO AN APPROVED PLAN. THE PLAN
SHOULD INCLUDE A DEMONSTRATION OF HOW THE SCHOOL WOULD USE TAX CREDITS,
PUBLIC FUNDS, OR OTHER INCENTIVES TO AID DIRECTLY OR INDIRECTLY IN
DEVELOPMENT OF INVESTMENT VEHICLES FOR RESEARCHERS, AND TO ENGAGE IN
ACTIVITIES CRITICAL TO THE COMMERCIALIZATION OF RESEARCH. SUCH FUNDING
AND COLLABORATIONS SHOULD ALSO SHOW HOW THE CENTER HAS OR WILL DEVELOP
LEVERAGED CREATIVE PARTNERSHIPS TO PROVIDE ANGEL, SEED, PRE-SEED, AND
OTHER INVESTMENTS TO HELP EACH STAGE OF PRODUCT DEVELOPMENT, EVIDENCED
BY WRITTEN AGREEMENTS, MEMORANDUMS OF UNDERSTANDING, LETTERS OF INTENT,
OR OTHER ENDORSEMENTS ACCEPTABLE TO THE COMMITTEE.
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 JOBS, INVESTMENT, AND ECONOMIC AND OTHER ACTIV-
ITY, STATED IN A SPECIFIC AND MEASURABLE WAY THAT IS ACHIEVABLE AND
REALISTIC WITHIN THE PROJECT TIME FRAME AND THAT CAN BE QUANTIFIED AND
COMPARED TO OTHER DATA FOR ANALYSIS.
9. ADVISORY COUNCIL: AN INDEPENDENT ADVISORY COUNCIL 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 446. REVIEW AND APPROVAL OF APPLICATIONS. REVIEW OF APPLICATIONS
SHALL TAKE PLACE IN TWO STAGES, FIRST BY THE PEER REVIEW COMMITTEE AND
THEN BY THE STATE INITIATIVE COMMITTEE WHICH SHALL HAVE SOLE POWER TO
APPROVE AN APPLICATION, AS FOLLOWS:
1. THE COMMISSIONER SHALL REVIEW APPLICATIONS AND PLANS RECEIVED FOR
COMPLETENESS, AND THEN FORWARD THEM TO THE PEER REVIEW COMMITTEE, AND TO
THE STATE INITIATIVE COMMITTEE FOR ITS REVIEW AND FINAL DETERMINATION
ONLY AFTER REVIEW BY THE PEER REVIEW COMMITTEE. NO PLANS SHALL BE
APPROVED BY THE STATE INITIATIVE COMMITTEE UNTIL REVIEWED 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
S. 6555 6
AND DEEMED APPROPRIATE BY THE STATE INITIATIVE COMMITTEE, PLANS MAY BE
SUBMITTED BLIND TO THE PEER REVIEW PANEL.
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 INVESTIGATORS, COLLABORATORS, AND
OTHER RESEARCHERS TO THE PROJECT, INCLUDING THE EXPERIENCE AND TRAINING
OF STAFF AND COLLABORATORS;
(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. THE STATE INITIATIVE COMMITTEE SHALL REVIEW SUCH
RECOMMENDATIONS, AND MAY ADD TO THEM, PRIOR TO RETURNING THEM TO THE
APPLICANTS.
5. THE STATE INITIATIVE COMMITTEE WILL REVIEW ALL ASPECTS OF THE
APPLICATIONS AND PLANS SUBMITTED TO IT AND RECOMMEND CHANGES AND DETER-
MINE FUNDING LEVELS AND SOURCES TO BE INCLUDED IN THE UNIFIED CONTRACT
IF THE APPLICATION IS APPROVED. THE COMMITTEE WILL TAKE INTO CONSIDER-
ATION THE REVIEW OF THE PEER REVIEW COMMITTEE, AND SHALL NOT APPROVE A
PLAN DESIGNATED BY THE PEER REVIEW COMMITTEE AS NOT RECOMMENDED FOR
FURTHER CONSIDERATION (NRFC), BUT MAY ADD ITS OWN COMMENTS PRIOR TO
RETURNING IT TO THE APPLICANT MEDICAL SCHOOL.
6. THE STATE INITIATIVE COMMITTEE SHALL REVIEW AND SCORE PLANS BASED
ON THE CATEGORIES REQUIRED IN THE APPLICATION PURSUANT TO SECTION FOUR
HUNDRED FORTY-FIVE OF THIS ARTICLE, AND INCLUDING 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 REACH OF THE COLLAB-
ORATIONS AND RELATIONSHIPS 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; AND
(D) SUCH OTHER OBJECTIVE AND MEASURABLE CRITERIA AS SHALL BE DETER-
MINED BY THE COMMITTEE.
S. 6555 7
7. 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 RECOMMENDATIONS FOR AMENDMENT
AND MAY BE RESUBMITTED IN THE FOLLOWING YEAR.
8. INSOFAR AS PRACTICABLE, IN APPROVING APPLICATIONS, THE COMMITTEE
SHALL SEEK TO PROVIDE A GEOGRAPHICALLY BALANCED DISTRIBUTION OF NEW YORK
STATE BIOMEDICAL AND BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTRE-
PRENEURSHIP INITIATIVE CENTERS AMONG THE REGIONS OF THE STATE.
9. NOT MORE THAN FORTY PERCENT OF FUNDS APPROPRIATED PURSUANT TO THIS
ARTICLE SHALL BE USED FOR ANY SINGLE PROJECT.
10. AS SOON AS PRACTICABLE AFTER APPROVING AN APPLICATION THE COMMIT-
TEE 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 A BRIEF DESCRIPTION OF THE PROJECT.
S 447. 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 REQUIREMENTS THAT MAY IMPEDE THE SUCCESSFUL
IMPLEMENTATION OF A PROJECT UNDERTAKEN PURSUANT TO THE APPROVED PLAN BY
THE CENTER, PROVIDED THAT SUCH WAIVER IS CONSISTENT WITH APPLICABLE
STATE AND FEDERAL STATUTES AND WILL NOT IMPAIR THE GENERAL HEALTH OR
WELFARE OF THE PEOPLE RECEIVING SERVICES UNDER SUCH PROJECT OR OTHERS.
SUCH COMMISSIONER 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 448. OPERATION AND REDESIGNATION 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 MEET ALL REQUIREMENTS CONCERNING EXECUTION AND IMPLEMENTA-
TION OF AN APPROVED PLAN FOR ITS PROJECT, TO MAINTAIN BEST PRACTICES,
AND TO REPORT DATA AS REQUESTED OR REQUIRED TO THE DEPARTMENT AND/OR THE
STATE INITIATIVE COMMITTEE USING APPROPRIATE CONFIDENTIALITY PROTOCOLS
IN THE CASE OF BUSINESS OR TRADE SECRETS. SUCH DATA WILL INCLUDE A
DEMONSTRATION OF THE SUCCESS IN MEETING PROJECT PLAN GOALS, INCLUDING
YEAR BY YEAR COMPARISON OF RESEARCH ACTIVITY AND COMMERCIALIZATION THER-
EOF, 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 ELECTRON-
ICALLY.
THE COMMISSIONER ON BEHALF 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 SPECIFIED
INFORMATION, AND REVIEW EVALUATIONS. IF THE STATE INITIATIVE COMMITTEE
IS UNSATISFIED WITH THE PROGRESS OF A PROJECT, THE COMMISSIONER SHALL
NOTIFY SUCH CENTER OF THE RESULTS OF THE EVALUATIONS AND ANY FINDINGS OF
DEFICIENCIES IN ITS OPERATIONS AND SHALL COOPERATE WITH SUCH CENTER TO
REMEDY SUCH FINDINGS IN A TIMELY MANNER. SUCH EVALUATIONS SHALL INCLUDE
PEER REVIEW AND SHALL TAKE PLACE NO LESS THAN ONCE EVERY THREE YEARS OR
MORE OFTEN FOR ANY INDIVIDUAL CENTER AT THE DISCRETION OF THE STATE
S. 6555 8
INITIATIVE COMMITTEE. SUCH PEER REVIEW SHALL RESULT IN A WRITTEN REPORT
THAT INCLUDES PROGRAMMATIC AND FISCAL EVALUATION OF THE PROJECT AND
RECOMMENDATIONS FOR IMPROVEMENT. MEMBERS OF SUCH PEER REVIEW GROUP SHALL
BE CHOSEN IN THE SAME WAY AND HAVE THE SAME QUALIFICATIONS AS MEMBERS OF
THE PEER REVIEW COMMITTEE.
FAILURE TO ABIDE BY THE REQUIREMENTS OF THIS SECTION OR TO CURE A
DEFAULT AFTER REVIEW AND AGREEMENT WITH THE STATE INITIATIVE COMMITTEE
SHALL RESULT IN DISQUALIFICATION AS A NEW YORK STATE BIOMEDICAL AND
BIOTECHNOLOGICAL TRANSLATIONAL RESEARCH AND ENTREPRENEURSHIP INITIATIVE
CENTER.
A CENTER SHALL BE DEEMED REDESIGNATED UPON APPLICATION EVERY THREE
YEARS UNLESS IT SHALL RECEIVE A NEGATIVE EVALUATION FROM THE PEER REVIEW
GROUP FOLLOWED BY A DETERMINATION BY THE STATE INITIATIVE COMMITTEE NOT
TO REDESIGNATE THE CENTER BASED ON SUCH EVALUATION AND FAILURE TO REMEDY
DEFECTS OR A DETERMINATION BY THE COMMITTEE THAT SUCH DEFECTS ARE OF
SUCH A NATURE OR ARE OF SUCH EXTENT THAT THEY CANNOT BE REMEDIED.
S 449. 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 AND RETENTION OF
SCIENTISTS AND RESEARCHERS NECESSARY TO THE SUCCESSFUL IMPLEMENTATION OF
PROJECTS APPROVED PURSUANT TO THIS ARTICLE. MONIES SHALL BE MADE AVAIL-
ABLE TO CENTERS FROM FUNDS APPROPRIATED PURSUANT TO THIS ARTICLE, AFTER
REVIEW AND UPON APPROVAL BY THE STATE INITIATIVE COMMITTEE PURSUANT TO A
PLAN SUBMITTED BY A CENTER. SUCH PLAN MUST DEMONSTRATE TO THE SATISFAC-
TION OF THE COMMITTEE THAT THE CENTER HAS OR WILL HAVE DURING THE PERIOD
OF THE GRANT A MATCH OF TWO NON-STATE DOLLARS FOR EVERY STATE DOLLAR
PROVIDED PURSUANT TO THIS SUBDIVISION. PLANS MUST SHOW THE TIME-LINE 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 ESTAB-
LISH A SCHEDULE FOR PAYMENT OF THE AWARD. FUNDS PROVIDED PURSUANT TO
THIS SECTION MUST BE APPLIED DIRECTLY TO NECESSARY EXPENSES FOR RECRUIT-
MENT AND RETENTION OF SCIENTISTS AND RESEARCHERS, AND MAY NOT BE USED
FOR INDIRECT OR OTHER OVERHEAD COSTS OF THE MEDICAL SCHOOL.
S 450. 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 DEPARTMENT OF AUDIT AND CONTROL. THE COMPTROLLER IS
AUTHORIZED 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 PAYMENT OF SUCH
OBLIGATIONS. THE DIVISION OF THE BUDGET SHALL PROVIDE THE CHAIRMEN OF
THE SENATE FINANCE COMMITTEE AND THE ASSEMBLY WAYS AND MEANS COMMITTEE
S. 6555 9
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 THROUGH THE CONTRACT SHALL NOT BE USED TO
SUPPLANT OTHER FUNDS.
3. 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 FOR OVER-
HEAD, 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 451. REPORT. THE COMMISSIONER ON BEHALF OF THE COMMITTEE SHALL ISSUE
AN ANNUAL REPORT TO THE PUBLIC, BEGINNING AT THE CONCLUSION OF THE FIRST
FULL CALENDAR YEAR AFTER THIS ARTICLE SHALL HAVE BECOME LAW, WHICH SETS
FORTH THE ACTIVITIES UNDERTAKEN PURSUANT TO THIS ARTICLE, INCLUDING THE
NAMES OF APPROVED PLANS AND THE CENTER SPONSORS, AND THE FOCUS OF
RESEARCH ACTIVITIES IN EACH SUCH PLAN; THE METRICS FOR EACH APPROVED
PLAN; GRANTS AWARDED, GRANTS IN PROGRESS, AND RESEARCH AND ENTREPRENEU-
RIAL ACCOMPLISHMENTS; FINANCING FROM EXTERNAL SOURCES FOR BRINGING
PRODUCTS TO MARKET; THE PROJECTED NUMBER OF JOBS AND COMPANIES TO BE
CREATED PURSUANT TO APPROVED PLANS AND THE ACTUAL NUMBER CREATED; ACTIV-
ITY UNDER THE DISCOVERY BANK CREATED PURSUANT TO THIS ARTICLE; A SUMMARY
OF FUNDING PROVIDED PURSUANT TO THE UNIFIED CONTRACTS EXECUTED PURSUANT
TO THIS ARTICLE; WAIVERS GRANTED PURSUANT TO THE AUTHORITY PROVIDED
UNDER THIS ARTICLE AND ACTIVITY UNDERTAKEN UNDER SUCH WAIVER; AND THE
NUMBER OF AND REASONS WHY PROJECTS WERE DEEMED NOT RECOMMENDED FOR
FURTHER CONSIDERATION.
S 3. This act shall take effect on the first of September next
succeeding the date on which it shall have become a law.