OFFICE OF MEDICAL CANNABIS
DRAFT REQUEST FOR APPLICATION & TIMELINE
August 8, 2014
Manny Munson-Regala
Assistant Commissioner
Jeff Smith
OMC Project Manager
Review RFA
• Why a Request for Applications?
• Current DRAFT RFA
• Application Content
• Evaluation & Selection Process
• Timeline
• Communication with the Department
• Intent to Apply
• Submission Logistics
Why a Request for Applications?
• Legislation does not identify the state needing to contract
with a manufacturer (the state is not buying anything)
• The State will simply register 2 manufacturers
• The State will NOT be a middleman in any cannabis transactions
• The RFA process provides for:
1.
2.
A rigorous and consistent process
Flexibility to request manufacturer capabilities in areas important to
the Department
Current Draft RFA
• The RFA is in Draft form; what does this mean?
• The document will change between now and September 5th
• The amount of time to create a Response is very short, in order to have
a complete and successful response we expect applicants to start
developing their RFA response prior to September 5th
• We have asked for a large amount of data, we are doing this because
we want manufacturers to both provide high quality medical cannabis
and be able to maintain successful businesses
• We would advise being very careful to ensure completeness
• We want to hear feedback, concerns and suggestions:
[email protected]
• All questions and their associated answers will be posted online
Application Content
• Business Overview
• Facilities
• Product Development
• Operations
• Business Plan
• Owner ship & Financial schedule
• Bonus Points
• Conclusion
Business Overview
• Section Intent / Goal:
• Your opportunity to summarize your approach and experience
• Examples of Important Requests:
• Experience and qualifications will be important in the evaluation
process, we will touch on this several times throughout. Our desire
is to have manufacturers to have relevant experience
• Application Checklist is intended to have each Applicant to confirm
and be sure to understand the statutory requirements the State will
have of each manufacturer
Facilities
• Section Intent / Goal:
• Understand your desired Service Area
• Ensure that each manufacturer is ready to start development on
December 1st
• Service Areas:
• Odd Districts
• Minneapolis
• West Metro
• Western MN
• Southern MN
• Even Districts
• St. Paul
• Duluth & NE MN
• South Metro & SE MN
• St. Cloud & N and W Metro
Facilities (con’t)
• Examples of Important Requests:
• The locations of your manufacturing facility and your distribution
locations (and the dates you expect each distribution facility to be
operating)
• The more certainty you can provide regarding locations and local
community support the better
• We are requesting that no 2 distribution facilities be within 30 miles
of each other (with the exception of Districts 4 & 5)
• All documentation supporting ownership and zoning agreements
must be provided by November 14, 2014 in order to be registered
• Security and neighborhood impacts will be important
considerations
Product Development
• Section Intent / Goal:
• Your applicant team’s specific experience in growing plants and
turning plant material into a consumable product
• Examples of Important Requests:
• Demonstrating experience is very important
• Cultivation – a clear communication of processes and procedures
for operations including standard operating procedures, plant
traceability and chemical use
• Product Manufacturing – process and procedures will also be
important to manufacturing with a focus on product quality and
safety
Operations
• Section Intent / Goal:
• Allow us to understand how the full operations would function once
you are fully operational with all facilities
• Examples of Important Requests:
• Basic operational expectations (hours, staff levels, etc.) of
cultivation, product manufacturing and distribution facilities
• Staffing – we want to understand how you will staff each portion of
your operations and what experience levels you will be hiring
• The more information you can provide about the staffing and
approach for the pharmacist’s interaction with patients the better
Business Plan
• Section Intent / Goal:
• We want to understand your expectations upon which your
business model is built
• Examples of Important Requests:
• Business Expectations – Details about prices for patients and your
ability to expand production, if demand supports
• Marketing – Community outreach will be important but must be in
keeping with the medical focus of the legislation
Ownership & Financial Structure
• Section Intent / Goal:
• We want to ensure the manufacturers we register are financially
stable and have an experienced management team
• Examples of Important Requests:
• Financial stability will be very important give that patient enrollment
is not fully known today
• Business management experience will be important given that
there are many variables that may change (new or different
conditions
Bonus Points
• Section Intent / Goal:
• To understand the commitment each manufacturer has to the
objectives of the overall program beyond just the production and
sale of medical cannabis
• Examples of Important Requests:
• While not required, a manufacturer’s commitment to the issues
contained in the Bonus Point section will enhance their scoring
• Special attention to the Compassionate Need Plan would be
advised
RFA Evaluation & Selection Process
• Evaluation & Selection Process
RFA Evaluation & Selection Process
• There will be 3 points after which applications will be
eliminated:
1.
Mandatory Qualification Criteria
2.
Application & Presentation Scoring
3.
Site Visits
#1
#2
#3
RFA Evaluation & Selection Process
• Mandatory Qualification Criteria:
1.
Did you send in a Letter of Intent to Apply by September 19, 2014?
2.
Is your RFA Response complete? All requested items responded to?
3.
Have you Passed all Pass/Fail criteria?
These are still under development
4.
Have you paid the Application Fee?
5.
Did you provide all materials requested (paper copies + CD, etc.)
RFA Evaluation & Selection Process
• Application & Presentation Scoring:
• There is a minimum score threshold of 750
• Scoring / Evaluation will be done by a broad panel
• Additional background research may be done on applicants
• Presentations are 90 minutes in length
• Presentations will not be scored separately but will assist in informing
the application scoring
RFA Evaluation & Selection Process
• Application & Presentation Scoring:
Application Section
Points Available
Business Overview
100
Facilities
175
Product Development
175
Operations
175
Business Plan
175
Financial Organization & Structure
175
Conclusion
25
Total
1000
Bonus Points
100
Total + Bonus Points
1100
RFA Evaluation & Selection Process
• Site Visits & Final Scoring:
• Semi-finalists will receive a site visit to review any existing operations and
potential Minnesota cannabis facilities
• The purpose of the site visits is to credentialize the experience noted in
the applications
• The site visit team will be smaller than the full application evaluation team
• The site visit scoring will be added to the application scores
• The site visit scoring criteria has not yet been finalized
Miscellaneous Items
• Your Proposal will be public record once the Manufacturer
Selection process is complete
• Please review and understand the Data Practices section
of the document, use “Trade Secret” sparingly where its
actually true and relevant
RFA Timeline
Manufacturer
Interested
Parties Mtg
Aug 8
Manufacturer
Presentations
Intent to Apply
Due
Sept 5
Manufacturer
RFA Published
Sept 19
Site Visits
Oct 3
Manufacturer
RFA due
Oct 13 - 24
Oct 30
Semi-finalists
Named
Nov 3 - 14
Dec 1
2 Manufacturers
Registered
RFA Timeline
The evaluation process will occur over the following timeline:
• Manufacturer Interest Parties Conference – August 8, 2014
• RFA Published – September 5, 2014
• Intent to Apply Due Date – September 19, 2014
• RFA Due Date – October 3, 2014
• Prospective Manufacturer Presentations – October 13 – 24, 2014
• Semi-finalists Named – October 30, 2014
• Semi-finalist Site Visits – November 3 – 14, 2014
• 2 Manufacturers Registered – December 1, 2014
Communication with the Department
• All questions about the RFA or RFA process must be forwarded to MDH only
by email at [email protected] with the subject line “Medical
Cannabis RFA Question.”
• Questions and answers of a substantive nature will be posted on the MDH
website http://www.health.state.mn.us/topics/cannabis so that all applicants
will have access to the same information.
• Questions received by the Department before Tuesday, September 23, 2014
will be answered
• Once the RFA is published on September 5, 2014, communications regarding
the RFA including verbal, telephone, written or internet initiated by or on
behalf of any applicant to any employee of the Department are prohibited.
• Any violation of this prohibition may result in the disqualification of the
applicant.
Intent to Apply
• We are requesting an Intent to Apply Letter be submitted to the Department
• Must be submitted to [email protected] by Friday,
September 19, 2014 at 3 PM
• Subject Line should be “Medical Cannabis RFA Intent to Apply –
Manufacturer Name”
• The Letter must contain the following information
• Manufacturer’s Name
• Names of the principle owners and operational decision makers for the organization
• The name telephone number and email address for whoever will be responsible for
responding to any questions that arise during the evaluations process
• Whether the Manufacturer requests a presentation should its application meet all mandatory
qualification criteria
• If an Intent to Apply letter is not received by MDH prior to 3 PM on September
19, 2014 any RFA Response from that applicant will NOT be accepted and
considered
Submission Logistics
• A complete RFA Response must include the following:
• An original and twenty (20) paper copies of the RFA response, all of which
must be single-sided and securely bound; and
• A CD containing an electronic version of your complete submission in a
searchable PDF file format.
• A twenty thousand dollar ($20,000) non-refundable application fee in the
form of a check, made out to:
Minnesota Department of Health – OMC
• Deadline:
• Friday, October 3, 2014 at 3:00 p.m. Central Daylight Time
• Submission Window Starts:
• Monday, September 22, 2014 at 10:00 a.m. Central Daylight Time
• Accepted weekdays between 10:00 a.m. and 3:00 p.m.
Submission Logistics
• Address:
Attn: Jeff Smith – Loading Dock
Minnesota Department of Health
Office of Medical Cannabis
625 Robert Street North
St. Paul, MN 55155
Normal
Entrance –
NO Deliveries
• Responses MUST be
delivered to the Loading
Dock
• Please Note: the Loading
Dock for the O.L. Freeman
building is located on the
west side of the building
which is accessible on Central
Park Avenue East, St. Paul
Loading
Dock