Request for Applications (RFA) Disease Control and Environmental Epidemiology Division

Marijuana Public Health Research Grants RFA #2902

Application documents are available at: www.colorado.gov/cdphe/researchers

Submission Instructions Email application package to: [email protected] ***PRELIMINARY Applications must be received by 5:00 p.m., JULY 22, 2016

Table of Contents

Background and Overview ……………………………………………………………

3

Purpose and Intent ……………………………………………………………………

4

Eligibility ………………………………………………………………………………

4

Project Budget, Timeline, Life of Project ……………………………………………

4

Funding Areas and Priorities …………………………………………………………

5

How to Apply ………………………………………………………………………….

7

Submission Instructions ………………………………………………………………

10

Application Technical Assistance ……………………………………………………

12

Application Timeline …………………………………………………………………

13

Review and Selection …………………………………………………………………

13

Post-Selection Process ………………………………………………………………..

15

Administrative Information ………………………………………………………….

16

I. BACKGROUND AND OVERVIEW A. Background The Colorado Department of Public Health and Environment (CDPHE) Retail Marijuana Health Monitoring Program has statutory responsibility through C.R.S. 25-1.5-110 to monitor changes in drug use patterns as well as hospital and scientific literature reports related to health effects associated with marijuana use. Based on this charge, CDPHE appointed a 13-member committee, the Retail Marijuana Public Health Advisory Committee (RMPHAC), to review scientific literature on the health effects of marijuana and Colorado-specific health outcome and use pattern data. Members of this committee consist of individuals in the fields of public health, medicine, epidemiology, and medical toxicology who have demonstrated expertise related to marijuana through their work, training, or research. During 2014, the RMPHAC systematically reviewed the scientific literature and data available on the medical effects and use patterns of marijuana. This work culminated with publishing a 188-page document “Monitoring Health Concerns Related to Marijuana in Colorado: 2014” www.colorado.gov/cdphe/scientific-literature-review-marijuana-related-health-effects . In this document and subsequent meetings, the Committee identified a number of research gaps that are important to public education or policy. CDPHE’s current Medical Marijuana Research Grant Program, also authorized by the 2014 Colorado legislature, supports research on the general medical efficacy of marijuana and its component parts as part of medical treatment. However, since the legalization of retail marijuana sales in Colorado beginning in 2014, there has been little research on general health effects of marijuana use in Colorado, especially in certain vulnerable populations. B. Definition of Terms 1. Biosketch: Biographical Sketch ("biosketch") is an abbreviated record of professional accomplishments. The National Institutes of Health (NIH) Biographical Sketch is the most common format. It is similar to a curriculum vitae but limited to five pages with information pertinent to the grant application. 2. Cannabidiol: one of the major cannabinoids found in marijuana, which has no intoxicating properties 3. Cannabinoid: a class of diverse chemical compounds found in marijuana, including THC and cannabidiol, that act on receptors in the human body; although more than 70 such compounds are contained in the plant, only a few are considered principal or major ones 4. CDPHE: The Colorado Department of Public Health and Environment (i.e., the state health department) 5. Clinical trials: intervention study design in which investigators administer an intervention (e.g., new drug) to study participants; includes the specialized case of a randomized controlled trial in which investigators randomly allocate eligible people to receive the intervention or placebo (i.e., control group) 6. Component parts: the principal cannabinoids of marijuana for which there is current medicinal use or interest, including ∆9-tetrahydrocannabinol (THC) and cannabidiol (CBD); these may either be extracted from the plant and purified, or synthesized 7. Dabbing: inhalation of a dose of marijuana concentrate that is heated on a hot surface and then inhaled through use of a special apparatus; concentrates are made by extracting THC and other cannabinoids using a solvent like butane or carbon dioxide, resulting in sticky oils 8. DEA: federal Drug Enforcement Agency 9. FDA: federal Food and Drug Administration Page 3 of 22

CDPHE RFA #2902

10. IRB: Institutional Review Board - also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans 11. Marijuana: seeds, leaves, buds, and flowers of the plant (genus) cannabis, including extracts and preparations derived from these 12. NIH: National Institutes of Health 13. Observational trials (studies): a type of study in which individuals are observed or certain outcomes are measured; no attempt is made to affect the outcome (for example, no treatment is given) 14. Pre-clinical studies: refer to the testing of a drug or other medical treatment in animals before trials may be carried out in humans; during preclinical drug development, the drug’s toxic and pharmacologic effects need to be evaluated 15. RMPHAC: Retail Marijuana Public Health Advisory Committee, a statutorily authorized and CDPHEappointed committee which reviews scientific literature on the health effects of marijuana and Colorado-specific health outcome and use pattern data 16. THC: ∆9-tetrahydrocannabinol, the most notable cannabinoid found in marijuana and the primary psychoactive compound of marijuana

II. PURPOSE AND INTENT The purpose and intent of this grant program is to fund scientific research that will address selected priority research gaps identified by the RMPHAC regarding the general health effects of marijuana use in Colorado’s population.

III. ELIGIBILITY Eligible organizations that may apply for funding (i.e., agencies submitting an application) include the following Colorado entities: not-for-profit higher education institutions, other not-for-profit entities, and governmental agencies. For-profit entities may partner with eligible organizations listed above, but may not be the primary applicant (i.e., the submitting agency). Principal investigators must be employees of the Colorado entities applying for funding. Principal investigators must have a demonstrated record of successful grant-funded research or data analysis (Pilot Grants). Preference will be given to studies involving Colorado residents, and studies involving analysis of Colorado data (Pilot Grants).

IV. PROJECT BUDGET, TIMELINE AND LIFE OF PROJECT A. Project Budget The 2016 Colorado legislature authorized CDPHE to spend up to $2.37 million from the Marijuana Tax Cash Fund beginning in FY 2016-17 (Year 1) through FY 2019-20 (Year 4) to fund marijuana public health research, pending future annual appropriations by the state legislature. Of the $2.37 million in total funds expected to be appropriated by the state legislature, up to the full amount may be Page 4 of 22

CDPHE RFA #2902

committed through this RFA to fund marijuana public health research projects beginning no earlier than March 1, 2017 for a project period of up to either two years for Pilot Grants or three years for Full Research Grants. B. Award Period (Life of Project) This RFA will result in single year contracts that may be renewed for a second (Pilot Grants and Full Research Grants) and third (Full Research Grants only) year, depending upon the proposed project duration. The initial contract will be effective upon approval by the State Controller. C. Award Size Full Research Grants will be up to $300,000 per year for up to three years of funding. Pilot Grants will be up to $100,000 per year for up to two years of funding.

V. FUNDING AREAS AND PRIORITIES A. Types of Studies to be Funded Two types of grants will be awarded as follows: 1. Pilot Grants: These grants are intended to fund shorter term projects that can provide important public health data with limited resources. Examples of pilot grants may include specific laboratory analyses of marijuana (see p.6: “Authorizations to conduct marijuana-related research”) or biological samples, analyses of existing data sets, small population-based surveys, and observational epidemiology studies. 2. Full Research Grants: These grants are intended to fund multi-year projects that involve extensive primary data collection using observational study designs. Examples of full research grants may include large population-based surveys, toxicology studies of dose response of different marijuana use methods and or potency/cannabinoid profiles, studies of drug interactions, and large observational epidemiology studies. Clinical trials should NOT be proposed. B. Priority Research Areas Applications for Pilot Grant and Full Research Grants should align with one or more of the following priority research areas: 1. Safety and effects of marijuana use on vulnerable populations such as pregnant/breastfeeding women and other sub-populations identified through health behavior or health outcome data: Examples include (but are not limited to): a. Effects of marijuana use by pregnant women on their offspring b. Cannabinoid content of breast milk of mothers who use marijuana c. Factors contributing to adolescent initiation of marijuana use d. Characterizing use of marijuana and risk factors in the LGBT population e. Characterizing potential health effects from accidental ingestion of marijuana products 2. Effects of increasing marijuana potency and changing cannabinoid profiles: Examples include (but are not limited to): a. Factors contributing to cannabis use disorder b. Changes in physical or mental health outcomes related to higher potency marijuana or from changing ratios of THC to other cannabinoids c. Assessing driving impairment from use of high potency products 3. Comparison of health outcomes in occasional versus heavy users Examples include (but are not limited to): a. Factors contributing to cannabis use disorder b. Changes in physical or mental health outcomes related to heavy use c. Assessing driving impairment of occasional users versus heavy users Page 5 of 22

CDPHE RFA #2902

4. Potential risks and/or risk reduction of alternative methods of marijuana use, or from using in addition or in place of other substances (i.e., alcohol, tobacco, other drugs) Examples include (but are not limited to): a. Pulmonary function in persons who smoke marijuana versus vaporize or ingest marijuana b. Relationship of marijuana use to reduction in opioid dependence c. Health effects from using marijuana in addition to other substances and/or prescription medications d. Health outcomes related to dabbing e. Assessing driving impairment from use of orally ingested marijuana products 5. Effects of contamination of marijuana by molds, pesticides, and heavy metals. Examples include (but are not limited to): a. Assessing types and prevalence of contamination in retail marijuana products b. Assessing health outcomes in persons using marijuana which contains contaminants C. Study Design Requirements 1. Studies involving primary data collection must measure frequency of marijuana use as number of times used per day or week (instead of numbers of days used per week), and methods of marijuana use 2. Studies involving primary data collection should assess occasional users separately from regular or heavy users; whereas, studies involving secondary analyses of existing data should do this to the extent possible. D. Cannabinoid Testing 1. Testing of marijuana or its component parts for chemical composition and potency by a state certified Colorado laboratory or another laboratory meeting similar quality standards and qualifications is strongly recommended as part of observational studies (in which the study subjects procure their own marijuana or component parts). 2. Testing of blood, serum, or plasma levels of cannabinoids are strongly recommended as part of observational studies in which such levels meaningfully contribute to study design, and should be performed by a College of American Pathologists (CAP) accredited laboratory with an appropriately sensitive, specific and validated assay using methodology such as high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). E. Authorizations to conduct marijuana-related research Under the Drug Free Schools and Communities Act, institutions of higher education have an obligation to comply with federal drug laws as a condition of receiving grant funding or other financial assistance under any federal program. As a Schedule I substance, it remains illegal under federal law to import, manufacture, distribute, possess, or use marijuana. However, federal law provides the Food and Drug Administration (FDA) with the ability to approve research using Schedule I controlled substances. The following guidance may apply to applicants depending upon the nature of the proposed study and the type and funding status of the applicant organization. Applicants from or affiliated with institutions of higher education should review this guidance with their organization’s office of legal council to determine its applicability. 1.

Human Clinical Trials: proposals NOT accepted under this RFA

2.

Human Observational Studies: These are studies in which subjects use marijuana (or its component parts), but the researcher does NOT procure it for the subjects, the marijuana/component parts is not consumed on the institution’s campus. For these types of studies, the researcher must obtain approval from the appropriate IRB

3.

BasicResearch: NOTE: this may pertain to contamination testing/studies:

Page 6 of 22

CDPHE RFA #2902

Under federal law, a researcher who wishes to use marijuana (or its component parts) for research (performed at an institution of higher education) that does not involve human subjects or animals, yet is directed toward greater knowledge or understanding of the fundamental aspects of marijuana must: a. Obtain a registration from the DEA b. Acquire the marijuana from the NIDA approved source. c. Follow DEA regulations and guidelines for storage and prescription

VI. HOW TO APPLY NOTE: Applications that fail to follow ALL of the requirements may NOT be reviewed. This will be a TWO-STEP application process. Brief PRELIMINARY applications will be reviewed for alignment and overall impact. A subset of applicants will be then be invited to submit FINAL applications, which must not differ substantively from the Preliminary submission in terms of the primary aim. A. PRELIMINARY Application - REQUIRED 1. Content The Preliminary Application should be NO MORE THAN 2 PAGES and contain the following information: a. Descriptive Title b. Lead organization or entity name c. Name, email, telephone number of Principal Investigator d. Collaborating organization(s) or entity name(s) with names of co-investigators e. Indicate whether Pilot Grant vs. Full Research Grant f. Type of Study and/or study Design g. Proposed duration of project h. Approximate amount of funding being requested for the entire project i. Primary and Secondary aims j. Brief description of study methods (including analysis plans as appropriate) k. Describe & justify how proposed study aligns with priority research areas (pp. 5-6) 2. Formatting Applications should follow all the formatting requirements: a. Application Font: Times New Roman b. Application Font Size: 11 point minimum c. Application Spacing: Single or double spaced, 0.5” - 1” margins on all sides d. Submit PDF file with principal investigator’s first initial and last name as the filename (e.g., Jsmith.pdf)

B. FINAL Application – by INVITATION (based on review of Preliminary Application) NOTE: This must not differ substantively from the Preliminary submission in terms of the primary aim. 1. Application Page Formatting and Length Applications must follow all the formatting requirements: a. Application Font: Times New Roman b. Application Font Size: 11 point minimum c. Application Spacing: Single or double spaced, 0.5” - 1” margins on all sides d. Page Numbering: Number all pages at the bottom e. Page Limits – applications that exceed these page limits will NOT be reviewed: i. Executive Summary: no more than 1 page Page 7 of 22

CDPHE RFA #2902

f.

ii. Description of Key personnel: no more than 2 pages iii. Narrative/Research Plan: (parts A-D below) no more than 10 pages Headings: use the headings listed in this guidance

2. Attachments Other than biosketches/resumes of key personnel (see below) and the required forms (Attachments A-C) that are part of the application packet, NO other attachments are allowed (and if submitted, will NOT be reviewed). ` 3. Application Executive Summary (no more than 1 page) a. Describe the purpose/intent of the proposed project. b. Clearly state how the project meets the purpose and intent of the grant program, including how the proposed project has clear benefit for Colorado residents. c. State the purpose, key aims and expected outcomes. d. Summarize the study design and methods, including analysis plan 4. Description of Experience/Qualifications of Key Personnel (no more than 2 pages) a. Describe the principal investigator’s demonstrated record of successful grant-funded research or secondary data analysis (for pilot grants). b. Describe the training and past experience of key personnel relevant to the proposed project, including scientists, clinicians, epidemiologists, statisticians, and other staff involved with study coordination or conduct. c.Attach biosketches or resumes, limited to 5 pages each, of all PIs and co-investigators. 5. Application Narrative/Research Plan The application narrative must address each section clearly and concisely, and include all of the required information for the section. a. Background & Significance i. Clearly describe the issue/problem that your project proposes to address. o State primary specific aim o State secondary aim(s) ii. Summarize relevant peer-reviewed scientific journal articles and other publications. iii. Provide complete list of references cited (within this section and NOT as an attachment). iv. For Full Research Grants, provide plans to prepare and submit a manuscript of research findings from the proposed project, whether positive or negative, to a suitable peer-review journal (applicants should budget time and estimated costs for draft manuscript preparation during the final project year, which will meet the final reporting requirement). v. For Pilot Grants, provide plans to prepare a final report of research findings and to present the findings at a local meeting or conference. vi. Provide any plans to present research findings at local or national conferences (applicants should budget travel for presentations at out-of-state conferences, as appropriate, if this will occur during the contract cycle) b. Capacity/Program Infrastructure Describe applicant’s (i.e., organizational entity’s) infrastructure and capacity to support the proposed project, including experience successfully conducting similar studies. c. Research Design and Methods Describe the overall project design and methods, including: i. Overview ii. Plans to obtain applicable federal authorizations, if needed iii. Subjects and procedures iv. Recruitment Page 8 of 22

CDPHE RFA #2902

v. Protection of human subjects vi. Control group or comparison group (as appropriate) vii. Measurements (clinical/laboratory, surveys, questionnaires) viii. Documentation of adverse effects ix. Statistical analysis o Staffing o Sample size and power calculations o Primary analysis o Secondary analyses d. Laboratory Testing Describe plans for cannabinoid and related testing by certified/accredited laboratories, and describe qualifications of laboratories being proposed to conduct testing along with methods to be used for: i. marijuana or its component parts for chemical composition and potency ii. blood, serum, or plasma cannabinoid levels e. Budget A budget template is provided and can be found as Attachment B. i. Please provide a detailed budget for the first budget year (i.e., 12 months) using the spreadsheet provided. ii. Do not modify the format of the spreadsheet. The budget must explain all expenses included. iii. Applicants are responsible for ensuring the calculations in the budget are accurate. iv. Detailed subcontractor budgets must be provided using separate copies of the same budget template. v. There will be no reimbursement of pre-award costs. vi. CDPHE reserves the right to deny requests for any item listed in the budget that is deemed to be unnecessary for the implementation of the project. vii. Unallowable Expenses: Funds from this grant may not be used for: o capital construction o building renovations (without prior approval from CDPHE) o lobbying o conference attendance other than for scientific presentation regarding the proposed project (international travel, except to Canada, for conference presentation will not be supported) o cell phones viii. Indirect Rate: o Indirect costs are limited to a maximum of 15 percent of direct costs (i.e., personal services, supplies and operating, travel, other). For the contractual budget category, the primary applicant agency is limited to a maximum indirect cost (“flow through” on subcontracts) rate of 2 percent.

o

Agencies that have indirect costs less than the15 percent cap should reflect their indirect costs at the actual rate. The method of allocating indirect costs (overhead to be allocated and the basis of allocation) shall comply with generally accepted accounting principles that are consistently applied. Agencies that do not have indirect costs should not collect indirect costs and should budget for all costs in the appropriate direct cost category.

o

This same indirect cost rate guidance is applicable to any subcontractor(s) as well.

f. Budget Categories: i. Personal Services List all personnel to perform work for the project. Include proposed salaries, time and effort percentage (full time equivalent or FTE), and fringe benefits. In the “Description of Work” column, include the role and expected contribution of budgeted personnel. ii. Supplies and Operating Page 9 of 22

CDPHE RFA #2902

Include a list of all allowable supplies and operating expenses, and show calculations. The justification (“Description of Item” column) should describe the rationale, necessity and reasonableness of the costs budgeted. iii. Travel Include all travel and indicate whether in-state or out-of-state. Travel to out-of-state conferences must involve formal scientific presentation of the funded project. Funding for international conference attendance is not allowed. iv. Other Include items not included in the previous budget categories. - Requests for equipment are at the discretion of CDPHE. Equipment with a unit cost of less than $5,000 is considered a supply (e.g., desktop or laptop computers). - If equipment costs are granted, the equipment remains the property of CDPHE. - If equipment is not used exclusively to conduct project activities funded in your application, clearly describe how you will allocate the equipment costs to other funding sources so that funds awarded from this announcement pay only for the portion used to conduct stated activities. - Large equipment purchases may require additional insurance requirements. The contractor’s estimates for those costs should be included. - Grantees may not generally use the funding for the purchase of furniture or certain types of large equipment. Any such proposed spending must be indentified in the budget and may be disallowed. v. Contractual Include all subcontracts planned to complete the proposed work. Detailed subcontractor budgets must be provided using separate copies of the same budget template (Attachment B) used for the overall project budget. Restrictions outlined in the budget guidelines, including cost reimbursement terms, shall also apply to subcontracts. No subcontractor may be pre-paid for services. vi. Future Years Funding Estimates o Provide estimates of Year 2 (both Pilot and Full Research grants) and Year 3 (Full Research Grants only) funding, if applicable, in spaces provided BOTH at the bottom of the main budget (Attachment B), AND in the Applicant Information Form (Attachment A). o Applicants should budget time and estimated costs for draft manuscript preparation (Full Research Grants) or final reports (Pilot Grants) during the final project year; these will meet the final reporting requirement. o Detailed budgets will be required prior to awarding of funds for conducting future year activities for approved projects.

VII. SUBMISSION INSTRUCTIONS A. Overview 1. This Request for Applications (RFA) is issued by the Retail Marijuana Health Monitoring Program, Disease Control and Environmental Epidemiology Division at the Colorado Department of Public Health and Environment (CDPHE), also referred to as the "State". 2. During the solicitation process for this RFA, all official communication with Applicants will be via notices on the CDPHE marijuana researchers web page. Notices may include any modifications to administrative or performance requirements, answers to inquiries received, clarifications to requirements, and the announcement of selected grantees. Applicants are responsible for monitoring for publication of modifications to this solicitation. It is incumbent upon Applicants to carefully and regularly monitor for any such notices. Applicants are not to contact any other state office or individual regarding this RFA. Applicants are not to rely on any other statements that alter any specification or other term or condition of the solicitation. Page 10 of 22

CDPHE RFA #2902

3. Applications must be received on or before the due date and time as indicated below: LATE APPLICATIONS WILL NOT BE ACCEPTED a. It is the responsibility of the Applicant to ensure that its PRELIMINARY Application and FINAL Application (if invited) are received via email (instructions below) by the CDPHE Retail Marijuana Health Monitoring Program on or before the due date and time. Hard copy applications will NOT be accepted. b. All materials submitted shall become the property of the CDPHE, and will not be returned unless the RFA solicitation is cancelled prior to the submittal due date, in which case applications will be returned unopened or opened only for identification purposes. c. All materials submitted will become public record and open to inspection after the award notice is issued. Any materials requested to be treated as confidential and/or proprietary information are to be packaged separately and clearly identified. Such request must include justification for the request. The request will be reviewed and either approved or denied in writing by the CDPHE Purchasing Director. If denied, the proposer will have the opportunity to withdraw its entire application, or to remove the restrictions. (Ref §24-72-201 et.seq, C.R.S., as amended, Public [open] Records) Neither cost nor pricing information or a total application will be considered confidential and/or proprietary. B. FINAL Application Submission Checklist An application that is missing any of the items listed below will be considered INCOMPLETE and NOT reviewed. The forms and templates provided are REQUIRED. Applications will not be accepted in any other format. 1.  Cover letter signed by executive director or authorized official of applicant agency 2.  Attachment A: Applicant Information Form 3.  Attachment B: Budget Template 4.  Detailed sub-contractor budget(s) using budget template (Attachment B) 5.  Application Executive Summary 6.  Description of key personnel 7.  Application narrative/research plan 8.  Attachment C: W-9 Form 9.  Biosketches/resumes of co-investigators (limited to maximum of 5 pages each) 10.  Documentation of applicant organization’s non-profit status in the form of either IRS approved 501 status or incorporation as a non-profit in state of Colorado. NOTE: not-for-profit higher education institutions and governmental agencies do NOT need to submit this documentation. C. Submission and Deadline 1. All PRELIMINARY Applications must be received via EMAIL by the Colorado Department of Public Health and Environment by 5:00 p.m. MDT on July 22, 2016. 2. All FINAL applications (if invited) must be received via EMAIL by the Colorado Department of Public Health and Environment by 5:00 p.m. MDT on September 30, 2016 3. Late applications and those not submitted via email will not be accepted. 4. Applications that do not include all required components will not be reviewed. Email application package to: [email protected] Preliminary Application should be attached to the submission email as a PDF file Page 11 of 22

CDPHE RFA #2902

All Final Application (if invited) components should be attached to the submission email as PDF files Applicants will receive email confirmation of receipt of Preliminary and Final applications.

D. Submission agreement: By submission of an application, the Applicant agrees as follows: 1. Awarded applicants are required to provide a valid insurance certificate prior to commencement of any work or services. It is a provision of the contract that all applicable insurance coverages remain in effect during the contract and that a new certificate is provided to the CDPHE each time coverage is renewed. 2. Applicant testifies that submitted prices were arrived at independently and there was no collusion involved. 3. The Applicant guarantees to the State that it understands and agrees to the terms and conditions of this solicitation and that they will not default from performance by virtue of a mistake or misunderstanding. Applicants shall seek clarification from the CDPHE Program Contact of any specifications, terms and/or conditions that they determine to be unclear. The failure of an applicant to seek clarification may be deemed a waiver of any such clarification. 4. Pursuant to C.R.S. §24-30-202.4 (as amended), the State Controller may withhold debts owed to State agencies under the vendor offset intercept system for: (a) unpaid child support debt or child support arrearages; (b) unpaid balance of tax, accrued interest, or other charges specified in Article 22, Title 39, C.R.S.; (c) unpaid loans due to the student loan division of the department of higher education; (d) owed amounts required to be paid to the unemployment compensation fund; and (e) other unpaid debts owing to the State or any agency thereof, the amount of which is found to be owing as a result of final agency determination or reduced to judgment as certified by the Controller. 5. The CDPHE reserves the right to reject any and all applications or parts thereof, and to waive informalities or irregularities.

VIII. APPLICATION TECHNICAL ASSISTANCE A. Inquiries 1. Applicants may submit questions via email to obtain clarification of requirements concerning this RFA by 5:00 p.m. MDT on July 8, 2016. No inquiries will be accepted after this date and time. Send all questions to: [email protected] 2. Clearly identify your inquiries with: a. ”RFA #2902” in the subject line of the email b. Marijuana Public Health Research Grants Program c. The page and section to which the inquiry applies. 3. Responses to applicant questions will be posted on the CDPHE marijuana researchers web page by close of business on the date indicated in the Application Timeline listed below. Applicants are not to rely on any other statements that alter any specification or other term or condition of the RFA. B. Pre-application Conference No Pre-application conference will be held. Please submit all inquiries as instructed above.

Page 12 of 22

CDPHE RFA #2902

IX. APPLICATION TIMELINE RFA release

6/30/2016

Deadline for applicants to submit written questions related to the RFA. Submit all inquiries by email to: [email protected]

7/8/2016

Responses to submitted questions will be posted by this date here

7/15/2016

PRELIMINARY Application SUBMISSION DEADLINE

7/22/2016

PRELIMINARY Application review process

[8/3 – 8/17]

Reviewer meeting to determine selection for FINAL application

[8/24 – 8/26]

Notifications of selection for FINAL Applications

[8/29 – 8/31]

FINAL Application SUBMISSION DEADLINE

9/30/2016

FINAL Application review process

[10/7 - 10/31]

Reviewer meeting to determine funding

[11/7 – 11/11]

Anticipated grant award start date

3/01/2016

X. REVIEW AND SELECTION A. PRELIMINARY Applications 1. Applications will initially be screened by CDPHE for completeness and adherence to the purpose/intent, eligibility criteria, and instructions of this RFA (p. 7). Incomplete PRELIMINARY Applications, as well as those not clearly consistent with the purpose/intent, eligibility criteria, and page limits will NOT be further reviewed. 2. Three reviewers will be assigned to each PRELIMINARY Application to perform review and provide a Preliminary Impact Score. The scores will be averaged for each application, and the top scoring applicants for both Pilot and Full Research grants will be discussed at a Preliminary Reviewer Meeting. During this meeting, reviewers will decide which applicants will be invited to submit FINAL applications, based on: the averaged Preliminary Impact Scores; alignment with RFA priorities; preference for studies of Colorado residents and analysis of Colorado data; and overall goal of funding projects across priority areas. Up to 6 Full Research Grants and 10 Pilot Grants will be invited to submit Final applications. 3. The Preliminary Impact Score reflects an assessment of alignment, impact, scientific approach, and the likelihood for the project to exert a significant contribution to the goal of addressing one or more selected priority research areas regarding the general health effects of marijuana use in Colorado’s population. A 10-point rating scale (10 = exceptional; 1 = poor) will be used. B. FINAL Applications 1. Applications will initially be screened by CDPHE for completeness and adherence to the purpose/intent, eligibility criteria, and instructions of this RFA (pp. 7-10). Incomplete applications, as well as those not clearly consistent with the purpose/intent, eligibility criteria, and page limits will NOT be further reviewed. 2. Three primary reviewers will be assigned to review and score each application. Applications will be evaluated for scientific and technical merit and likelihood of significant impact. Page 13 of 22

CDPHE RFA #2902

3. Review Criteria The 7 criteria described below will be used during the primary review process. a. Alignment How well does the proposal align with one or more of the five priority research areas (pp. 5-6). b. Impact i. If the aims of the project are achieved, how will public health knowledge and practice be improved? ii. How will successful completion of the aims change evidence-based public health policy and education related to marijuana use? iii. Does the applicant provide plans to prepare and submit a manuscript (Full Research Grants) whether positive or negative to a suitable peer-review journal, or final report (Pilot Grants) of research findings? c. Investigators i. Are the Principal Investigator(s), collaborator(s), or other researchers well suited to the project? ii. If early stage investigators, do they have appropriate experience and training? iii. If established investigators, have they demonstrated an ongoing record of accomplishments, including peerreview publications? iv. If the project is collaborative or multi-PI, do the investigators have complementary and integrated expertise; is the organizational structure appropriate for the project? d. Scientific approach i. Are the overall strategy, methods, and analyses well-reasoned, appropriate, and feasible to accomplish the specific aims of the project? ii. Are appropriate and meaningful outcomes measured, including those based on laboratory testing? iii. Is recommended laboratory testing described where applicable? iv. Are the procedures for collecting and analyzing data and proposed statistical methods appropriate? v. Do the analysis plans clearly specify, to the extent possible, assessment of frequency of marijuana use as number of times used per day or week, methods of use, and the assessment of occasional users separately from regular or heavy users? e. Environment i. Will the scientific environment in which the work will be done contribute to the probability of success? ii. Are the agency/organization support, equipment and other physical resources available to the investigators adequate for the project proposed? iii.Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? f. Protection of human subject If the project involves human subjects, are there adequate plans to address the protection of human subjects from research risks, including plans for the project to be reviewed, approved and monitored by a suitable Institutional Review Board? g. Budget i. Is the overall budget, as well as subcontract budgets, reasonable considering the scope of research activities? ii. Does the budget provide adequate detail to justify each line item in the amount requested? 4. Overall Impact Score This score is not necessarily the average of the 7 individual criterion scores. Rather, it reflects an overall assessment of the likelihood for the project to exert a significant contribution to the goal of addressing one or more selected priority research areas regarding the general health effects of marijuana use in Colorado’s population. Proposals that differ substantively in terms of the primary aim from the Preliminary application will be penalized on the Overall Impact Score. Page 14 of 22

CDPHE RFA #2902

5. Application Review Process/Scoring a. A 10-point rating scale (10 = exceptional; 1 = poor) will be used for the 7 review criteria and for the overall impact score. b. Primary reviewers will assign a working score (i.e., not to be submitted) for each of the 7 review criteria above. These scores will inform their assignment of a Primary Review Overall Impact Score which will then be averaged with those of the other two primary reviewers for each application to determine which applications are discussed and re-scored at a face-to-face meeting of all (available) Final application stage primary reviewers. c. During the face-to-face meeting, Pilot and Full Research proposals will be discussed separately. After each top scoring application from primary review is presented and discussed, eligible primary reviewers (without conflicts of interest) will provide FINAL Overall Impact Scores. The average of these scores will then be calculated and multiplied by ten. Thus, the resulting score will range from 100 (exceptional impact) to 10 (poor impact). d. Final funding decisions will be based on: Final Overall Impact Scores; alignment with RFA priorities; preference for studies of Colorado residents and analysis of Colorado data; and the overall goal of funding projects across priority areas. 6. Notification and Decision a. Final applicants will be notified in writing as to whether they were selected for funding. b. Final award decisions will be made by CDPHE and are not subject to an appeals process. Concerns or complaints about the RFA process and its outcomes should be submitted to the attention of the Retail Marijuana Health Monitoring Program via email at: [email protected] . Include the phrase “RFA Concerns” in the email subject line.

XI. POST SELECTION PROCESS A. Funding Restrictions For projects that involve human subjects, contracts will not be executed and funding will not be awarded until approval by a federally recognized Institutional Review Board (IRB) has been submitted to CDPHE. B. Contract Negotiation Process The State reserves the right to request revisions to the budget or scope of work (i.e., research plan) of any applicant. C. Reporting Grantees must submit ongoing progress reports, due two weeks following the end of each calendar quarter, that at a minimum include numbers of patients enrolled and any scientifically valid preliminary results: 1. Quarterly progress reports 2. Annual updates which may replace the fourth fiscal quarter report 3. Final report at the end of project funding – which for Full Research Grants takes the form of a draft manuscript for publication and includes the following sections: Introduction, Methods, Results, Discussion, Conclusions. For Pilot Grants, the final report may either take the form of a draft manuscript for publication, or may take the form of a final report of research findings for local use and dissemination, depending on which is most appropriate. D. Insurance Requirements Successful applicants must comply with the State’s insurance requirements to protect the grantee and the state from any damages or loss. The grantee will need to submit certificates of insurance demonstrating coverage for Professional Liability and other coverage required by the State as outlined below. The certificate must include the State of Colorado as an additional insured on the Commercial General Liability and Automobile Liability Insurance policies* and Commercial General Liability Insurance written on ISO occurrence form CG 00 01 10/93 or Page 15 of 22

CDPHE RFA #2902

equivalent, covering premises operations, fire damage, independent contractors, products and completed operations, blanket contractual liability, personal injury, and advertising liability with minimum limits as follows: - $1,000,000 each occurrence - $1,000,000 general aggregate - $1,000,000 products and completed operations aggregate - $50,000 any one fire * Automobile Liability Insurance covering any auto (including owned, hired and non-owned autos) with a minimum limit as follows: $1,000,000 each accident combined single limit.

XII. ADMINISTRATIVE INFORMATION By submission of an application, the applicant agrees as follows: A.

Acceptance of RFA Terms An application submitted in response to this RFA shall constitute a binding offer. The autographic signature of the applicant or of a designee legally authorized to execute contractual obligations shall indicate acknowledgment of this condition. A submission in response to this RFA acknowledges acceptance by the applicant of all terms and conditions, including compensation, as set forth herein.

B.

Colorado Contract General Provisions and Special Provisions The State of Colorado will incorporate standard General Provisions and Special Provisions into any contract resulting from this RFA. Minor elements of the General Provisions may be negotiable. The terms of the Special Provisions are non-negotiable. A sample of the most recent version of the General Provisions and Special Provisions can be found in Attachment D. Provisions that actually appear in the final contract will reflect the approved State version at the time of contract execution.

C.

Modification or Withdrawal of Applications Applications may be modified or withdrawn by the applicant prior to the established submission due date and time.

D.

Addendum or Supplement to Request for Applications In the event that it becomes necessary to revise any part of this RFA, a modification will be posted here . It shall be the responsibility of the applicants to regularly monitor this web site for any such postings. Failure to retrieve such modifications, and include their provisions in your application, may result in your application being disqualified. Should the applicant find any part of the solicitation to be discrepant, incomplete, or otherwise questionable in any respect, the applicant shall be responsible to call such matters to the attention of the purchasing agent immediately. Failure to do so shall be at the applicant’s risk. Amendments to this solicitation will be official only if published here . Applicants should not rely on verbal statements that alter this solicitation.

E.

Oral Presentations/Site Visits Applicants may be asked to make oral presentations or to make their facilities available for a site inspection by the evaluation committee. Such presentations and/or site visits will be at the applicant's expense.

F.

Rejection of Applications The State of Colorado reserves the right to reject any or all applications received in response to this RFA, to waive informalities and minor irregularities in applications received, and to accept any portion of an application or all items proposed if deemed in the best interest of the State of Colorado to do so. Page 16 of 22

CDPHE RFA #2902

G.

Confidential/Proprietary Information Any restrictions of the use or inspection of material contained within the application shall be clearly stated in the application itself. Written requests for confidentiality shall be submitted by the applicant with the application. The applicant must state specifically what elements of the application are to be considered confidential/proprietary and must state the statutory basis for the request under the Public (open) Records Act. (§24-72-201 et seq., C.R.S.) Confidential or proprietary information must be readily identified, marked and separated from the rest of the application. Co-mingling of confidential and/or proprietary and other information is NOT acceptable. Neither an application in its entirety, nor application price information will be considered confidential and proprietary. Any information that will be included in any contract resulting from the RFA cannot be considered confidential. The CDPHE will make a written determination as to the apparent validity of any written request for confidentiality. In the event the CDPHE does not concur with the applicant’s request for confidentiality, the written determination will be sent to the applicant. Ref §24-72-201 et seq., C.R.S., as amended, Public (open) Records Act. Applicant(s) acknowledge that they may come into contact with confidential information contained in the records or files of the State in connection with any resulting contract or in connection with the performance of its obligations under any resulting contract. The awarded applicant(s) shall keep such records and information confidential and shall comply with all laws and regulations concerning the confidentiality of such records to the same extent as such laws and regulations apply to the State. The awarded applicant(s) shall notify its employees that they are subject to the confidentiality requirements as set forth above, and shall provide each employee with a written explanation of the confidentiality requirement before the employee is permitted access to confidential data. Awarded applicant(s) shall provide and maintain a secure environment that ensures confidentiality. The confidentiality of all information will be respected and no confidential information shall be distributed or sold to any third party nor used by awarded applicant(s) or its assignees and/or subcontractors in any way except as authorized by this contract. Confidential information shall not be retained in any files or otherwise by awarded applicant(s). Disclosure of such information may be cause for legal action against the awarded applicant(s). Defense of any such action shall be the sole responsibility of the awarded applicant(s). Unless directed otherwise, awarded applicant(s) is required to keep all State information in a secure, confidential manner.

H.

Response Material Ownership The State of Colorado has the right to retain the original application and other RFA response materials for our files. As such, the State of Colorado may retain or dispose of all copies as is lawfully deemed appropriate. The State of Colorado has the right to use any or all information/material presented in reply to the RFA, subject to limitations outlined in the Proprietary/Confidential Information clause. Applicant expressly agrees that the State may use the materials for all lawful State purposes, including the right to reproduce copies of the material submitted for purposes of evaluation, and to make the information available to the public in accordance with the provisions of the Public Records Act.

I.

Application Prices Applicant testifies that submitted prices were arrived at independently and there was no collusion involved. Estimated application prices are not acceptable. Application prices should be best and final offer, unless otherwise stated in the RFA. The application price will be considered in determining the apparent successful applicant. Applications shall be firm for a period of not less than one-hundredtwenty (120) calendar days. Payments will be based on deliverables as outlined in the resulting contract. It is anticipated that payments may be made on a monthly basis after receipt and approval of awarded vendor’s invoice. Receipts for travel will be required, if allowed. No payment shall be made Page 17 of 22

CDPHE RFA #2902

until after the contract has been negotiated and properly executed (signed by State Controller or designee). J.

RFA Cancellation The State reserves the right to cancel this Request for Application in its entirety or individual phases at any time, without penalty.

K.

Conflict of Interest/Organizational Conflict of Interest By submission of a RFA response, the applicant agrees that at the time of contracting the proposer has no interest, direct or indirect, that would conflict in any manner or degree with the performance of the required services and obligations. The applicant shall guarantee that in the performance of the contract they shall not employ any person having any such known interest. Applicants are required to disclose all current or pending projects with the State of Colorado, and/or political subdivisions. Applicants must include all potential conflicts related to this solicitation and any other services related to this project at the time of response submission and during contract performance. Applicants must explain any State employment affiliation. Any business entity or person is prohibited from being awarded a contract if the business entity or person has an “Organizational Conflict of Interest” with regard to this solicitation and the resulting contract(s). No person or business entity who was engaged by the State to prepare the original RFA shall be eligible to participate (directly or indirectly) in the submission of an application for this solicitation IF: 1. 2.

Such person or entity had prior access to source selection information related to this procurement process, and That prior access included, but was not limited to: requirements, statements of work, or evaluation criteria.

The State considers such engagement or access to be an Organizational Conflict of Interest, which would cause such business entity or person to have an unfair competitive advantage. If the State determines that an Organizational Conflict of Interest exists, the State, at its discretion, may cancel the contract award. In the event the successful applicant was aware of an Organizational Conflict of Interest prior to the award of the contract and did not disclose the conflict to the procuring agency, the State may terminate the contract for default. The provisions of this clause must be included in all subcontracts for work to be performed by subcontractors in connection with the performance of the contract, with the terms “contract,” “contractor,” and “contracting officer” modified appropriately to preserve the State’s rights. L.

Present/Former Employee Standards of Conduct – Disclosures Pursuant to sections 24-18-101 and 201, et. seq., C.R.S., and section 24-50-507, C.R.S., former and present public employees and officials may not "be interested" in some State Agency contracts and are prohibited from engaging in certain activities in relation to State contracts. The State reserves the right to void or terminate contracts entered into in contravention of those provisions, or contracts in which a current State employee performs any contract administration function involving the use of State time or resources or that is otherwise contrary to State law. Notwithstanding the disclosure provisions in section 24-18-201, C.R.S., the State reserves the right to disqualify any application, or void or terminate any contract involving the participation or use of a present or former employee within the meaning of that section where such disqualification or termination is deemed to be in the best interest of the State. At the time of the submission of any application, the contractor shall disclose to the Procuring Agency the identity, organization, and nature of participation of any present or former employee (who terminated State employment within six months prior to the date of receipt of applications) participating in development of the application. Further, the contractor shall disclose Page 18 of 22

CDPHE RFA #2902

during contract performance the identity, organization, and nature of participation of any present or former employee (who terminated State employment within six months prior to the date of any resulting contract or purchase order). M.

Alternative Bids or Offers/Affiliated Vendors Unless otherwise permitted by the Procuring Agency, alternative applications by any vendor are not permitted. Unless otherwise permitted by the Procuring Agency, applications by affiliated vendors are not permitted except in accordance with this paragraph. An affiliated vendor is one who is controlled or owned by another vendor responding to this solicitation, or owned or controlled by a third person or other entity that controls or owns two vendors responding to this solicitation. "Affiliation" includes one person's having a substantial role in the preparation of offers by two vendors responding to this solicitation. A submission of an application in connection with any solicitation represents a certification that the applicant is not affiliated with any known vendor also submitting an application in response to the solicitation, except to the extent the nature of such affiliation is described with particularity. The State reserves the right to disqualify any application by, or void any resulting purchase order or contract with, any vendor responding to a solicitation in violation of this provision or the following certificate of independent price determination.

N.

Certification of Independent Price Determination 1. By submission of this application, each applicant certifies, and in the case of a joint application, each party thereto certifies as to its own organization, that in connection with this procurement: a. The prices in this application have been arrived at independently, without consultation, communication, or agreement for the purpose of restricting competition, as to any matter relating to such prices with any other applicant or with any competitor; b. Unless otherwise required by law, the prices which have been submitted in this application have not been knowingly disclosed by the applicant and will not knowingly be disclosed by the applicant prior to opening, directly or indirectly to any other applicant or to any competitor; and c. No attempt has been made or will be made by the applicant to induce any other person or firm to submit or not submit a application for the purpose of restricting competition. 2. Each person signing the Request for Application Cover Sheet & Signature Page of this application certifies that: a. The signing individual is the person in the applicant's organization responsible within that organization for the decision as to the prices being offered herein and that he has not participated, and will not participate, in any action contrary to K.(1)(a) through K.(1)(c) above; or b. He is not the person in the applicant's organization responsible within that organization for the decision as to the prices being offered herein but that he has been authorized in writing to act as agent for the persons responsible for such decision, in certifying that such persons have not participated, and will not participate, in any action contrary to (1)(a) through (1)(c) above, and as their agent does hereby so certify; and he has not participated, and will not participate, in any action contrary to K.(1)(a) through K.(1)(c) above. 3. An application will not be considered for award where K.(1)(a), K.(1)(c), or K.(2) above have been deleted or modified. Where K.(1)(b) above has been deleted or modified, the application will not be considered for award unless the applicant furnishes with the application a signed statement which sets forth in detail the circumstances of the disclosure and the head of the agency (CDPHE) determines that such disclosure was not made for the purpose of restricting competition.

O.

Selection of Successful Application and Notice of Intent to Award The State reserves the right to make an award on receipt of initial applications, so applicants are encouraged to submit their most favorable application at the time established for receipt of applications. Applicants not meeting the requirements identified in the RFA shall be ineligible for further consideration. The State may conduct discussions with applicants in the competitive range (those most responsive to the requirements and reasonably susceptible of being selected for award) for Page 19 of 22

CDPHE RFA #2902

the purpose of promoting understanding of the State’s requirements and the applicant’s application, to clarify requirements, make adjustments in services to be performed, and in prices. Changes to applications, if permitted, will be requested in writing from applicants. If application revisions are permitted after oral presentations and discussions, a date will be established in writing by the State for submission of best and final offers (BAFO). Applicants will not be provided an opportunity for comprehensive application revisions. P.

Requirement for Valid Contract The State Agency will not be responsible for any products delivered or services performed prior to issuance of a purchase order signed by an authorized representative of the State Agency's purchasing department, or a contract signed by a duly authorized representative of the State Agency and approved by the State Controller or designee.

Q.

Vendor Forms In the event applicant's form(s) or part(s) of forms are included as an attachment(s) applicant agrees that, in the event of inconsistencies or contradictions, the terms and conditions of the solicitation document shall supersede and control over those contained in the applicant's form(s) regardless of any statement to the contrary in an applicant form(s). Unless the State specifically agrees in writing through overt reference or other express written indication of assent, terms and conditions on vendor forms regarding choice of law, venue, warranty disclaimer or exclusion, indemnification or limitation of liability shall be of no effect.

R.

Award of Contract/Standard (Model) Contract/Legislative Changes The award will be made to that applicant(s) whose application, conforming to the RFA, has been determined to be responsive and responsible and most advantageous to the State of Colorado, considering the evaluation factors set forth in this announcement. A contract must be completed and signed by all parties. In the event the parties are unable to enter into a contract in a reasonable timeframe, the State may elect to rescind the "Notice of Intent to Make an Award" communication and make the award to the next most responsive and responsible applicant. The successful applicant(s) is required to enter into a formal Contract with CDPHE. The State of Colorado reserves the right to amend the contract in response to future legislative changes that affect this project.

S.

Reciprocity Reciprocity is mandated by statute. C.R.S. §8-18-101 states, “When a contract for commodities or services is to be awarded to a bidder, a resident bidder…shall be allowed a preference against a nonresident bidder equal to the preference given or required by the state in which the nonresident bidder is a resident”.

T.

Term of the Contract This RFA may result in one or more multiple year contracts with renewal periods not to exceed three years. The initial contract will be effective upon approval by the State Controller's designee for one year. The contract may be renewed for up to two additional one-year periods, at the sole discretion of the State, contingent upon contractual requirements being satisfied and funds being appropriated, budgeted, and otherwise made available.

U.

Acceptance of Application Content The contents of the application (including persons specified to implement the project) of the successful applicant will become contractual obligations if acquisition action ensues. Failure of the successful applicant to accept these obligations in a contract, purchase document, delivery order or similar acquisition instrument may result in cancellation of the award and such applicant may be removed from future solicitations.

V.

Order of Precedence In the event of any conflict or inconsistency between terms of this request for application and the offer, such conflict or inconsistency shall be resolved first, by giving effect to the terms and conditions of the contract, second to the request for application, and third, to the application. Page 20 of 22

CDPHE RFA #2902

W.

Venue The parties agree that venue for any action related to performance of this application shall be in the City and County of Denver, Colorado.

X.

Withholding of Debts Owed to State Agencies Pursuant to C.R.S. §24-30-202.4 (as amended), the State Controller may withhold debts owed to State agencies under the vendor offset intercept system for: (a) unpaid child support debt or child support arrearages; (b) unpaid balance of tax, accrued interest, or other charges specified in Article 22, Title 39, C.R.S.; (c) unpaid loans due to the student loan division of the department of higher education; (d) owed amounts required to be paid to the unemployment compensation fund; and (e) other unpaid debts owing to the State or any agency thereof, the amount of which is found to be owing as a result of final agency determination or reduced to judgment as certified by the Controller.

Y.

State Ownership of Contract Products / Services All products/services produced in response to the contract resulting from this RFA will be the sole property of the State of Colorado, unless otherwise noted in the RFA.

Z.

Incurring Costs The State of Colorado is not liable for any cost incurred by applicants prior to issuance of a legally executed contract or procurement document. No property interest of any nature shall occur until a contract is awarded and signed by all concerned parties.

AA.

Non-Discrimination The applicant shall comply with all applicable state and federal laws, rules and regulations involving non-discrimination on the basis of race, color, religion, national origin, age or sex.

BB.

Parent Company If an applicant is owned or controlled by a parent company, the name, main office address, and parent company’s tax identification number must be provided in the solicitation response. The tax identification number provided must be that of the applicant responding to the RFA. The applicant must be a legal entity with the legal right to contract and must be registered in the State of Colorado to conduct business.

CC.

News Releases No news releases pertaining to this RFA shall be made prior to execution of the contract without prior written approval of CDPHE.

DD.

Contract Cancellation CDPHE reserves the right to cancel, for cause, convenience, or lack of fiscal funding, any contract resulting from this RFA by providing timely notice to the contractor.

EE.

Taxes CDPHE, as purchaser, is exempt from all federal excise taxes under Chapter 32 of the Internal Revenue Code (Registration No. 84-730123K). CDPHE’s Colorado State and Local Sales Tax Exemption Number is 98-02565. Applicant is hereby notified that when materials are purchased in certain political sub-divisions (for example in the City of Denver) the applicant may be required to pay sales tax even though the ultimate product or service is provided to the State of Colorado. This sales tax will not be reimbursed by the State.

FF.

Assignment and Delegation Except for assignment of antitrust claims, neither party to any resulting contract may assign or delegate any portion of the contract without the prior written consent of the other party. Awarded contractor(s) will be allowed to subcontract portions of this RFA. Awarded contractor(s) shall be fully accountable to the CDPHE and shall ensure that all subcontractors agree to and comply with the terms and conditions of the contract. During contract performance, the CDPHE may request and awarded vendor(s) shall provide proof of subcontractor compliance with CDPHE terms and conditions. Page 21 of 22

CDPHE RFA #2902

GG.

Availability of Funds Financial obligations of the State payable after the current fiscal year are contingent upon funds for that purpose being appropriated, budgeted, and otherwise made available. In the event funds are not appropriated, any resulting contract will become null and void, without penalty to the State of Colorado.

Page 22 of 22

CDPHE RFA #2902