Request for Application for the Registration of Medical Cannabis Manufacturers Summary
On August 1, 2014, the Minnesota Department of Health published the Request for Application (“RFA”) for the Registration of Medical Cannabis Manufacturers. You can find the document here (note that the RFA is subject to change and may have changed since the publication of this article.)
This article will touch on some of the highlights.
Coverage Areas of Manufacturers
- The MDH anticipates that one manufacturer will serve the portion of the state that encompasses the 1,3,5, and 7th Congressional Districts (Service Area “A”) and the other manufacturer will serve the 2,4,6, and 8th Congressional Districts (Service Area “B”).
- The MDH does not have to select two manufacturers. If it is believed that less than two manufacturers are qualified, they may only award one license. If that is the case, then they will issue a second RFA.
Intent to Apply Letter & Application
An “Intent to Apply” letter must be emailed to health.cannabis.RFA@state.mn.us by Friday, September 19, 2014 at 3:00 p.m. Central Time in order to be considered. The Intent to Apply letter must contain the following:
- Manufacturer’s name
- Names of the principal 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 evaluation process
- Whether the manufacturer requests a presentation should its application meet all mandatory qualification criteria.
The complete application must include:
- An original and 20 paper copies,
- A CD with an electronic version that is a searchable PDF, and
- A nonrefundable $20,000 check.
The deadline for the application is October 3, 2014 by 3:00 p.m. Central Time. The application must be hand delivered. The application must be received by an MDH employee and time stamped. Late application will not be accepted.
Modifications to the application can be made at any time prior to the October 3, 2014 deadline.
Communication with the MDH
Communication with the MDH can only be done via email at health.cannabis.RFA@state.mn.us. However, if you want your question answered you must submit it before September 23, 2014. If any communication is attempted in any other way it may result in disqualification of the applicant.
Data Practices & Trade Secrets
- All material submitted to the MDH will become property of the MDH.
- Data submitted during the application process are private data on individuals or nonpublic data as in Minnesota Statutes section 13.02 until the manufacturer is registered.
- Data on a manufacturer is that is registered are public data, unless the data are trade secret or security information under Minnesota Statutes section 13.37.
- If trade secret information is submitted with the RFA and the applicant does not want the data disclosed for any other purpose that the evaluation, then the applicant must clearly mark every page of trade secret materials with the words “TRADE SECRET INFORMATION” in at least 20 point font, and fill out and submit the “Trade Secret Information Notification Form,” and satisfies the statutory burden to justify any claim of trade secret information.
- Prices or costs are NOT considered trade secret information under any circumstance.
- The MDH is required to keep all basic documents for the successful manufacturers for at least 6 years. Non-selected RFAs are kept for at least one year.
Each information item included in the RFA must be responded to. If the application does not contain a response for each requested item, then the application will be disqualified and not scored. If you do not have information available, but it must be so stated. The general information areas are:
- Provide a brief summary of the applicant’s qualifications, experience, and industry knowledge.
- Complete the Application Checklist.
- Indicate whether wanted to Service Area A or Area B. An applicant can submit for both areas, but must then submit two applications, one for each area.
- The facility development portion must include detailed information that includes the location of the proposed facility, photographs of the surrounding neighborhood, a site plan, etc, as well as detailed information on the cultivation and distribution facility.
- Detailed information on the experience of producing pharmaceutical grade Cannabis as well as a detailed description of the applicant’s cultivation process, among other things.
- Information is also requested about the experience of the applicant in manufacturing finished medication.
- Detailed information regarding cultivation and manufacturing operations including the house of operation, number of staff, training, etc., as well as details on product transportation, technology use, and disaster recovery.
- Which includes business expectations, such as production capacity and an ability to expand capacity, and a marketing plan with any templates and educational materials such as brochures or promotional items.
Ownership & Financial Structure
- Must include articles of incorporation, articles of association, charter, by-laws, partnership agreement, or any other agreements, as well as an organizational chart, resumes, compensation agreements, criminal and civil litigation history, nature of any debt (bonds, mortgages, lines of credit, etc), financial statements, and tax returns from last three years.
- An applicant can provide related to certain categories such as employee working environment, compassionate need plan, research plan, community benefits, plan, substance abuse prevention plan, environmental plan, and health equity. If an applicant is chosen that included a bonus point category, the commitment in the bonus point category becomes a condition of their registration.
- A summary of why the applicant feels their application and proposal is the best choice for Minnesota. As well as the contact information for whoever will be the responsible person to respond to any questions that arise and signatures of principle owners.
Evaluation and Selection Process
The MDH will conduct a “comprehensive, fair, and impartial evaluation” of all applications. They will review all of the applications, then discard the incomplete applications, select semi-finalists and conduct site visits, then do the final scoring and select the finalist(s).
- Prospective manufacturers may have an opportunity to provide presentations during October 13-14, 2014
- Semi-finalists will be names by October 30, 2014
- Site visits will occur on November 3-4, 2014
- Two finalists selected November 17-26, 2014
- Registration of Manufacturers December 1, 2014
- The maximum score is 1000 (1100 of all Value Add items are included).
- Applicants must achieve a minimum score of 750 to be considered for registration.
- The MDH might contact references and background checks of varying degree to aid in the evaluation.
- The applicant for the MDH can request a 90 minute in-person presentation, however, they will not be scored separately.
- Up to three will be selected.
- A site visit of each semi-finalist will be requested.
- The MDH will rank the semi-finalist in each service area according to the combined score totals.
- The highest score in each service area, that meet the minimum score threshold, will be identified as Finalists and will proceed to the process of securing manufacturing registration.
- If the highest ranked applicants in both service areas have overlapping investors, directors, owners, officers or other high-level employees, the MDH will award the registration to the next highest ranked applicant without such an overlap.