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ITEM 4.5 MinnMedP OtCI�ezoz MINNESOTA CDP DEPARTMENT INFORMATION Request for City Council Action ORIGINATING DEPARTMENT: REQUESTOR: MEETING DATE: Planning City Planner Licht 22 September 2014 PRESENTER(s): REVIEWED BY: ITEM #: City Planner Licht City Administrator Johnson 4.5 — MinnMed City Attorney MacArthur AGENDA ITEM DETAILS RECOMMENDATION: This item is for information purposes o ARE YOU SEEKING APPROVAL OF A CONTRACT? M BACKGROUND/JUSTIFICATION: as no action is required by the City Council. IS A PUBLIC HEARING REQUIRED? No. City staff has had discussions with Minnesota Medical Solutions LLC (MinnMed) regarding location of a Minnesota State licensed medical cannabis growing facility on PID 118-800-281201 within the City of Otsego. Representatives of MinnMed will attend the City Council meeting on 22 September 2014 to make a presentation regarding their proposal to provide medical cannabis to a limited population with defined medical needs as allowed by State law. If MinnMed is awarded one of the two available licenses to be issued by the State, they would establish one cultivation and four dispensary facilities. Only the cultivation facility is proposed to be located in Otsego. The proposed location of the cultivation facility is on property zoned A-2, Agriculture Long Range Urban Service District. Agricultural related uses and greenhouses, which our office, the Building Official and City Attorney agree the proposed growing facility would be defined as based on information provided by MinnMed, are a permitted use within the A-2 District. Furthermore, based on the comprehensive regulations outlined in the Minnesota Department of Health Rules, as proposed, and MinnMed's operational procedures, City staff does not anticipate any negative effects caused by the cultivation facility in terms of public health, safety and welfare or land use compatibility. So long as it is constructed and operated in accordance with the Statues and Rules of the State of Minnesota, City staff regards the proposed cultivation facility, as has been represented by MinnMed, as a permitted agricultural use of the property under the Zoning Ordinance. Our office, in our capacity as the Zoning Administrator, has signed the zoning certification portion of the Minnesota Department of Heath license application form to this effect. The MinnMed proposal also includes a Community Support Plan component, whereby the corporation enters into an agreement with the City to provide a financial donation to be used for public benefit at the City Council's discretion. The Community Support Plan calls for two percent of MinnMed's annual net profits to be donated to the City, or a minimum amount of $20,000 for the first two years, whichever is greater. The agreement outlines possible public uses for the donation, but such use is ultimately solely determined by the City Council. The agreement also provides indemnification language drafted by the City Attorney to hold the City harmless from any claims to the donations that may arise out of actions against MinnMed. SUPPORTING DOCUMENTS: ❑ ATTACHED ❑ NONE A. MinnMed letter dated September 2, 2014 B. Wright County Sheriff's letter dated September 4, 2014 C. U.S. Department of Justice letter dated October 19, 2009 D. Minnesota Department of Health Medical Cannabis Manufacturer Q&As E. Minnesota Rules Chapter 4770 F. Minnesota Statutes Chapter 311 G. Minnesota Department of Health RFA POSSIBLE MOTION Please word motion as you would like it to appear in the minutes. No City Council action is required. BUDGET INFORMATION FUNDING: BUDGETED: ❑ YES NA ❑ NO ACTION TAKEN ❑ APPROVED AS REQUESTED ❑ DENIED ❑ TABLED ❑ OTHER (List changes) COMMENTS: I�innesot� Medical Solutions LLC September 2, 2014 City of Otsego Attn: City Council 13400 90th Street NE Otsego, MN 55330 Re: Medical Cannabis Manufacturing Facility Dear Otsego City Council: Minnesota Medical Solutions LLC (MinnMed) is a patient -centered group of physicians, pharmacists, scientists and other Minnesotans with national partners and cannabis industry consultants that is looking to provide medical cannabis for the highly restricted patient population in Minnesota. Many of these patient are in dire need of additional treatment options for their severe illnesses. We are looking to do this the right way for Minnesota and our communities. MinnMed is very excited to outline our complete vision and team to the city council of Otsego in the coming weeks. We greatly appreciate the Council's time and consideration of our proposal to use a greenhouse facility as a medical cannabis cultivation facility in the City of Otsego. We are very excited about the prospect of partnering with the City of Otsego and, if successful in our bid to obtain a cannabis -based medicine production license, becoming a pillar of support to the community with generous donations of a fixed percentage of profits to the community and real, living wage jobs with benefits. We have attached a proposed agreement with the city of Otsego. As you may have seen, several cities in Minnesota are actively seeking the cannabis production facility given the jobs it will bring. We are also particularly excited about the design and location of our facility, as we feel it has no substantial downside for the community of Otsego. We will be very responsible with water use, waste generation and energy consumption. The location is also very discrete and far from any population areas. We are submitting this letter ahead of the Council's meeting on September 8th to provide a brief overview of the application process and the State's requirements regarding the proposed cultivation facility. We also outlined what we hope to obtain from the City to show compliance Minnesota Medical Solutions, LLC 5200 Willson Road, Suite 150, Edina, MN 55424 City of Otsego September 2, 2014 Page 2 with the application requirements and to move forward and use this greenhouse as a cannabis cultivation and production facility in Otsego if awarded a license. Overview of the Application Process The Minnesota Department of Health ("MDH") is responsible for administering the newly enacted Medical Cannabis program. MDH is awarding two manufacturing licenses. Each manufacturer will be allowed one manufacturing (cultivation) facility and four dispensaries. One manufacturer will serve the 1, 3, 5 and 7t' Congressional Districts and the other will serve the 2, 4, 6 and 8h Districts, with one dispensary located in each district. A manufacturer has the option of attaching a dispensary to its cultivation/manufacturing facility to fulfill the dispensary requirement for that District, however, Minnesota Medical Solutions will NOT be adding a dispensary to our proposed Otsego facility. Per Minnesota Statute, the manufacturer must have one dispensary open to provide medical cannabis to patients by July 1, 2015, with all four open and operational by July 1, 2016. MDH will release the Request for Application ("RFA") on September 5, 2014, with the deadline to apply being October 3, 2014. Although the RFA has yet to be released, MDH has posted drafts of the RFA and Proposed Rules. According to the Draft RFA, the application must contain detailed information on the following: a) Business Overview and Plan b) Proposed Facilities c) Product Development d) Operations e) Ownership & Financial Structure Each applicant must notify the State of its intent to apply by September 19th and pay a nonrefundable fee of $20,000. Prospective manufacturers who submit applications and meet the mandatory requirements will be asked to give presentations which will take place October 13- 24th. Semi-finalists will be named on October 30, 2014, and MDH will perform site visits from November 3 -14th. The two finalists will be selected from November 17 -26th, with the two manufacturers being registered with MDR on December 1st. Cultivation Facility Requirements The State has created some general statutory requirements for cultivation facilities, with the more specific requirements being created in the Rules. The most specific statutory requirements which pertain to our discussion are regarding location, security and signage. Pursuant to statute, a manufacturer shall implement security requirements which include protection of each location by a fully operational security alarm system, facility access controls, perimeter intrusion detection systems, and a personnel identification system. § 159.29 Sub. 1(d). Further, a manufacturer may not operate in any location, whether for distribution or cultivation, harvesting, manufacturing, packaging, or processing, within 1,000 feet of a public or private school existing before the date of the manufacturer's registration with the commissioner. § 159.29 Sub. 10). City of Otsego September 2, 2014 Page 3 Finally, a manufacturer shall comply with reasonable restrictions set by the commissioner relating to signage, marketing, display, and advertising of medical cannabis. § 159.29 Sub. 1(k). Based on comments from MDH, these signage requirements relate more to dispensaries than manufacturing facilities and will be established to prevent promotion of drug use or drug culture. Regardless, no signage will be present at our cultivation and manufacturing facility in Otsego. There are no requirements regarding the type of building to be used, however, all state and local zoning ordinances must be met. Any proposed facility will need to be in a location and have the type of structure that allows it to meet the strict security requirements imposed by the State. Minnesota Medical Solutions LLC (MinnMed) has a robust security plan and we feel that the proposed site is particularly easy to secure. MDH has also recently stated that the environmental impact of the facility will be a factor and this is very important to MinnMed. The MinnMed cultivation facility will be a greenhouse that is used to grow that cannabis plants. There is also a part of the greenhouse that will be used to extract the oil from the plant, much as essential oils or other plant oils are extracted from plant material. We anticipate 80% of the greenhouse once fully built will be used directly or indirectly to grow the cannabis plants. Actions Needed From the City According to the Draft RFA, an applicant must provide "documents sufficient to establish that the applicant is authorized to conduct business in Minnesota; and that state and local building, fire and zoning requirements and all applicable local ordinances are met for the proposed location of the production facility (Draft RFP, p. 12 emphasis added). The applicant must also submit a written statement or certification that the proposed facility complies with the statutory requirement that the facility is 1,000 feet from a school. Although it has not been specified in the Draft RFA, the is a chance the MDH will ask any semi- finalists to hold a public hearing in one of the communities where either a dispensary or the manufacturing facility is located sometime in late November. Regardless of whether MDH requires Minnesota Medical Solutions to eventually hold a public hearing in Otsego, we believe it is important to show support from the City of Otsego and the community at -large in our application submission. Thus, based on the foregoing, Minnesota Medical Solutions respectfully requests the City of Otsego provide the following: A letter from the City Planner stating the facility meets all state and local building, fire and zoning requirements; A letter from the Otsego City Counsel approving our proposal to use this greenhouse facility as a medical cannabis cultivation facility within the City; A letter of support from the City of Otsego welcoming Minnesota Medical Solutions to the community and showing support for our community plan. We understand if the City has further questions or concerns that need to be addressed and we will do whatever is asked by the Council or the Otsego community to help with this process. We City of Otsego September 2, 2014 Page 2 look forward to the meeting on September 8th. Once again, thank you for your time and consideration. We are very excited to work with the city of Otsego moving ahead. We look forward to the opportunity to showing the Otsego city council our team and vision for the patients of Minnesota on Sept. 8th. Please feel free to reach out to us at any time throughout this process with input or questions. Respectfully Submitted, Kjz.� Kyle Kingsley, M.D. CEO Minnesota Medical Solutions, LLC Minnesota Medical Solutions Information Regarding Zoning and Community Support This short narrative is designed to give the reader some idea of the process MinnMed intends to use to produce its cannabis -based oils and to outline the specifics of our proposed community support plan. Agricultural Use/Zoning The majority of the greenhouse facility will be used to grow the cannabis plants. During phase 1, nearly the entire facility (15k square feet) will be used to grow the plants, the only exception being the security and employee areas such as break rooms and bathrooms. Once the facility has been expanded to 30k square feet (if MinnMed obtains a license), oil extraction capabilities will be added. There will also be work areas for potting plants, modifying soil, storage, trimming plant materials, preparing/modifying water for the plants, and composting plant materials. Initially MinnMed will not have extensive laboratory facilities on site as the state requires third party testing of our products. The oil extraction process is very straight -forward with only natural carbon dioxide used to squeeze/pull out the plant oils in a small closed-loop machine. At this point NlinnMed plans on using only CO2 in the extraction process. In this process the plant material is mechanically ground into finer pieces and then inserted into a cylinder. CO2 is then passed through the cylinder, pulling out the whole plant oils/extracts. All CO2 remains in the system for repeat use. These oils are then expressed for collection. Some oils may require dilution and if this is necessary, all natural products are used as these will be consumed by our patients. The final step is placement of these oils into tubes or vaporizers for patient use. This is a simply manual injection of the oil. Some oils may also be placed into pill forms or gel caps using a simply manually operated machine. All gel caps, tubes, vaporizers and other packaging will not be produced on site, only filled with the plant oils. MinnMed feels strongly that wastes will be recycled, used to generate energy or composted. We anticipate once fully operational, 80% of the square footage of the greenhouse will be used directly or indirectly (potting, etc.) to grow the plants. The remainder will be used for storage, office space, oil extraction and placing the oils into prefabricated packaging. We urge Otsego to interpret the ordinance as an agricultural processing facility as almost all time and space will be used for growing the cannabis plant. We feel that Qtsego's current zoning is appropriate as many greenhouses in unpopulated areas are zoned as agricultural space, and we appreciate the clearance as agricultural use. We are happy to discuss additional details of the processes involved. MinnMed also intends to be completely transparent with the city of Otsego and any/all changes and planning will be done in conjunction with the city. Community Support With regard to our support of the Otsego community, the City of Otsego shall directly receive 2% of the net profits realized by MinnMed from its yearly medical cannabis operations within the State. The amount shall be paid to the City on or about June 1 of each year along with financial documents verifying to the satisfaction of the City that the amount submitted is in fact 2% of MinnMed's net profit for that year. MinnMed has indicated that in the first two years of operation it projects no profit. It has however agreed to contribute to the City of Otsego at least $20,000.00 for these first two years. In the event that a net profit is realized for those first two years and 2% of that net profit exceeds $20,000.00, MinnMed will contribute the higher amount to the City. The City of Otsego shall use the funds received to provide to residents of the City recreational activities, park and trails, public education, public safety, artistic and cultural presentations, community beautification, grants and scholarships or any other similar activity, service, or program that the City Council determines, at its sole discretion, will improve the City and the lives of its residents. MinnMed shall hold the City harmless and fully indemnify the City from any claims against the funds contributed to the City resulting from MinnMed's failure to comply with State statutes, rules, regulations and licensure conditions (including errors in financial reporting) or from any actions taken by the Federal government against MinnMed seeking return of funds contributed to the City of Otsego. In the event that MinnMed is awarded a manufacturing license by the State of Minnesota, MinnMed agrees to enter into a written Agreement with the City of Otsego memorializing the terms and conditions as stated above. The written agreement will be attached to the Community Program and shall become an enforceable condition of the manufacturing license issued by the State of Minnesota. Thank you, The MinnMed Team fr/4J-a 119 OF -Nn fi7 Sib or Dave l4iiller Administration 763-682-7622 Cbief Deputy 3800 Braddock Ave. PTE Dispateh 763-682-7600 Greg Howell Buffalo, AW- 5.531-3 Records 763-682-7630 Captain Civil 763-682-7646 Dan AnselmentWarrants 1-800.369-3667 Investigations 763-682-7688 763-682-7637 Captain Fan: 763-6629--'7610 :Tail Administration 76_682-7662 Pat O'll iley Victim 76� 684-4537 Jail Captain -Assistant September 4, 2014 Otsego City Council 13400 901h Street NE Otsego, MN 55330 Re: Minnesota Medical Solutions' Proposed Medical Cannabis Facility Dear Otsego City Council: My staff and I recently met with Dr. Kyle Kingsley and Ross Hussey of Minnesota Medical Solutions regarding a proposed medical cannabis cultivation facility in the City of Otsego. After discussing the proposed location and security concerns, the Wright County Sheriff s Office does not believe the location of the facility will have a negative effect on public safety. Therefore, so long as it is built and operated in accordance with Minnesota law, this office has no objection to the facility being located in the City of Otsego. Sincerely, oe Hagerty Wright County Sheriff The Deputy rluorney Gcncial U.S. Department of justice Office of the Deputy Attorney General {dfahJagroa, n.C. 20530 October 19, 2009 MEMORANDUMSEL ELE TED UNITED STATES ATTORNEYS �� FROM: David W. Ogden Deputy Attorney General SUBJECT: Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana This memorandum provides clarification and guidance to federal prosecutors in States that have enacted laws authorizing the medical use of marijuana. These laws vary in their substantive provisions and in the extent of state regulatory oversight, both among the enacting States and among local jurisdictions within those States. Rather than developing different guidelines for every possible variant of state and local law, this memorandum provides tubiform guidance to focus federal investigations and prosecutions in these States on core federal enforcement priorities. The Department of Justice is committed to the enforcement of the Controlled Substances Act in all States. Congress has determined that marijuana is a dangerous drug, and the illegal distribution and sale of marijuana is a serious crime and provides a significant source of revenue to large-scale criminal enterprises, gangs, and cartels. One timely example underscores the importance of our efforts to prosecute significant marijuana traffickers: marijuana distribution in the United States remains the single largest source of revenue for the Mexican cartels, The Department is also committed to making efficient and rational use of its limited investigative and prosecutorial resources. hi general, United States Attorneys are vested with "plenary authority with regard to federal criminal matters" within their districts. USAM 9-2.001. In exercising this authority, United States Attorneys are "invested by statute and delegation from the Attorney General with the broadest discretion in the exercise of such authority," Id' This authority should, of course, be exercised consistent with Department priorities and guidance. The prosecution of significant traffickers of illegal drugs, including marijuana, and the disruption of illegal drug manufacturing and trafficking networks continues to be a core priority in the Department's efforts against narcotics and dangerous drugs, and the Department's investigative and prosecutorial resources should be directed towards these objectives. As a general matter, pursuit of these priorities should not focus federal resources in your States on Memorandum for All United States Attorneys Page 2 Subject: Guidance Regarding Marijuana Enforcement • Preventing violence and the use of firearms in the cultivation and distribution of marijuana; • Preventing dragged driving and the exacerbation of other adverse public health consequences associated with marijuana use; • Preventing the growing of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands; and • Preventing marijuana possession or use on federal property. These priorities will continue to guide the Department's enforcement of the CSA against marijuana -related conduct. Thus, this memorandum serves as guidance to Department attorneys and law enforcement to focus their enforcement resources and efforts, including prosecution, on persons or organizations whose conduct interferes with any one or more of these priorities, regardless of state law.' Outside of these enforcement priorities, the federal government has traditionally relied on states and local law enforcement agencies to address marijuana activity through enforcement of their own narcotics laws. For example, the Department of Justice has not historically devoted resources to prosecuting individuals whose conduct is limited to possession of small amounts of marijuana for personal use on private property. Instead, the Department has left such lower -level or localized activity to state and local authorities and has stepped in to enforce the CSA only when the use, possession, cultivation, or distribution of marijuana has threatened to cause one of the harms identified above. The enactment of state laws that endeavor to authorize marijuana production, distribution, and possession by establishing a regulatory scheme for these purposes affects this traditional joint federal -state approach to narcotics enforcement. The Department's guidance in this memorandum rests on its expectation that states and local governments that have enacted laws authorizing marijuana -related conduct will implement strong and effective regulatory and enforcement systems that will address the threat those state laws could pose to public safety, public health, and other law enforcement interests. A system adequate to that task must not only contain robust controls and procedures on paper; it must also be effective in practice. Jurisdictions that have implemented systems that provide for regulation of marijuana activity ' These enforcement priorities are listed in general terms; each encompasses a variety of conduct that may merit civil or criminal enforcement of the CSA. By way of example only, the Department's interest in preventing the distribution of marijuana to minors would call for enforcement not just when an individual or entity sells or transfers marijuana to a minor, but also when marijuana trafficking takes place near an area associated with minors; when marijuana or marijuana -infused products are marketed in a manner to appeal to minors; or when marijuana is being diverted, directly or indirectly, and purposefully or otherwise, to minors. 1Y�u i.p apdum fQr:Selected UnAed States Attorneys :. Page 3 Memorandum for All United States Attorneys Page 4 Subject: Guidance Regarding Marijuana Enforcement As with the Department's previous statements on this subject, this memorandum is intended solely as a guide to the exercise of investigative and prosecutorial discretion. This memorandum does not alter in any way the Department's authority to enforce federal law, including federal laws relating to marijuana, regardless of state law. Neither the guidance herein nor any state or local law provides a legal defense to a violation of federal law, including any civil or criminal violation of the CSA. Even in jurisdictions with strong and effective regulatory systems, evidence that particular conduct threatens federal priorities will subject that person or entity to federal enforcement action, based on the circumstances. This memorandum is not intended to, does not, and may not be relied upon to create any rights, substantive or procedural, enforceable at law by any party in any matter civil or criminal. It applies prospectively to the exercise of prosecutorial discretion in future cases and does not provide defendants or subjects of enforcement action with a basis for reconsideration of any pending civil action or criminal prosecution. Finally, nothing herein precludes investigation or prosecution, even in the absence of any one of the factors listed above, in particular circumstances where investigation and prosecution otherwise serves an important federal interest. cc: Mythili Raman Acting Assistant Attorney General, Criminal Division Loretta E. Lynch United States Attorney Eastern District of New York Chair, Attorney General's Advisory Committee Michele M. Leonhart Administrator Drug Enforcement Administration H. Marshall Jarrett Director Executive Office for United States Attorneys Ronald T. Hosko Assistant Director Criminal Investigative Division Federal Bureau of Investigation _ Medical Cannabis Manufacturer Questions and Answers (htto: / /www.health.state.mn. us /index. htmI) Minnesota Department of Health Medical Cannabis Manufacturer Questions and Answers On this page: Distribution Questions Page 1 of 10 Will each manufacturer have four distribution sites or will there be a total four across Minnesota? Is MDH open to additional or different distribution methods or strategies beyond a tradition "retail" location? If so is that something that should be included in the application? Will telemedicine or automated dispensing be allowed with the medical cannabis program? Employee Questions • Is MDH planning worker protections and training on regulatory issues? • Does the law require or prevent patients from working for a manufacturer? Facility Questions • Why do there need to be two separate manufacturers with separate facilities? It is expensive to set up these operations. • Explain how having two manufacturers is in the best interest of the business and patients? This structure would seem to provide no competition. • Is there a cap on ware footage of facilities? • Are there any alternative energy reiluirements? • Is the Congressional District approach to services areas the best approach given the potential density of patients in the Twin Cities? • How will MDH determine which manufacturer will be allowed to have a distribution site if each manufacturer proposes sites within the 30 -mile radius limit? • How will the zoning and local approvals occur? Once a manufacturer is registered will they then need to get approval from their local municipality? • Does the manufacturing facility need to be in the service area assigned to the manufacturer? • How does this business legislation apply to Indian reservations? Health Care Practitioner Questions Can you clarify what the law means when it says there should be no financial relationship between a manufacturer and a health care practitioner? How does the program deal with doctors who decline to participate or refuse to certify a patient's condition? Laboratory Questions • What is the timeline for the lab approval by the Commissioner? • MDH stated that labs will need to be certified by 2016 but medical cannabis needs to be available in July 2015 How will that work for the labs /product testing? • Will the labs own the data that they collect when testing the products? Manufacturer Questions kftn-//xxnxnxT l,PnIA etnta mn html 9/26/2014 Medical Cannabis Manufacturer Questions and Answers Page 2 of 10 • We have heard that some pharmacists and CPAs may not want to be involved for fear of risking licensures Are manufacturers going to be able to get service providers and Pharmacists to work with or for them? • Why is the word manufacture used for both growing and manufacturing? • Does the manufacturer have to be a nonprofit organization or have a specific corporate structure? • What if the department cancels or revokes a manufacturer's registration? • What will be the re -registration process? • What if one manufacturer goes out of business? Manufacturer Application Fee Questions • Comment on the $20,000 application fee How many people are you aware of that are going to apply? Big players? Hospitals pharmaceutical companies, etc? • Who pays the $20,000 application fee? Only the winning manufacturers, or all parties who apply? • Is the $20,000 application fee refunded to those who are not registered as manufacturers? Manufacturer Application Questions • The RFA requests identifying employees How is an applicant supposed to have employees if they haven't been registered? • Is all of the data in the application going to be public? Including any financial information provided? • Should an applicant let you know if we want to give a presentation with our application? • Is MDH willing to travel out of state to conduct a site visit? • Does the applicant need to pay for the site visit? • Will bonus points be awarded for residents of Minnesota? • Will there be any special considerations for Minnesota ownership of a manufacturer? • MDH has noted the importance of experience in growing. When you evaluate applications will you only evaluate experience growing in legal settings? • What will happen if no one is capable and/or no one applies? • After the RFA submission due date passes will you communicate how many applications were received? • How would you handle having four high scores and two low scores in different service areas? Operations Questions • What will the initial demand for medical cannabis be? • How will unused medical cannabis be collected and disposed op. • Is there anything that would prohibit the manufacturer from billing a patient? • Are there different meanings for the words "batch" and "lot" in the Manufacturer Medical Cannabis Rules? • Will the State define how the active ingredients should be extracted? Will there be rules about what methods can or cannot be used? • Is there a system in place if there needs to be a recall? Patient Questions • Does the past felony rule apply to patients to parents to caregivers? • Will there be a pilot program that would allow an expedited start date for catastrophically ill children? • Do patients need to buy within their districts? • Is there an option for patients to try the products first? Testing them out in small doses? • What is the timeline for patient recommendations for conditions? • What portion of the S.000 patients are employed vs unemployed? • How many patients will there be? Medical Cannabis Manufacturer Questions and Answers Page 3 of 10 Pharmacist/Pharmacy Questions • Does a pharmacist need to be present at each location at time of distribution? • Can a pharmacy distribute medical cannabis? Product Questions • Will only certain cannabis chemical composition be required? • How can we ensure the product is safe and tested prior to July 1 given the number of activities that must be completed: growing, extracting creating and testing the dosages and compositions? • Will tincture or other medication that can be taken sublingually be allowed? • Can the oils be used in edibles and sold at the dispensary? • What is a pill? • Do you envision validation of the claims made by manufacturers? • Are there restrictions on the method of ingesting the oil liquid or pill? For example would a nasal spray be allowed? • Will testing the product both at growing and after processing be necessary? • Would you estimate a 6 9 or 12 -month shelf life? • Can the -manufacturers act as a research faciliW. Can new products be developed? For example could a manufacturer produce a topical cream as an alternative method for ingestion? Statute and Rules Questions • Are the expedited rules the law? • What protections would there be for investors against any federal violations? • Is there an easy way for industr�Lto know if a requested change is a legislative change or a rule change? Distribution Questions Will each manufacturer have four distribution sites or will there be a total four across Minnesota? Each manufacturer will need to have four distribution locations by July 1, 2016 which will result in a total of eight locations across the state. (8/11/14) Is MDH open to additional or different distribution methods or strategies beyond a tradition "retail' location? If so is that something that should be included in the application? MDH is interested in hearing the ideas applicants have regarding creating convenient methods to get medical cannabis to registered patients that align with the requirements stated in the statute. MDH encourages any ideas to be included in the application. (8/11/14) Will telemedicine or automated dispensing be allowed with the medical cannabis program? MDH is interested in collecting ideas on approaches that would allow telemedicine and be consistent with the Minnesota statute. Section 152.29 subsection 9.3(a) states "A manufacturer shall require that employees licensed as pharmacists pursuant to chapter 151 be the only employees to distribute the medical cannabis to a patient." (8/11/14) Employee Questions Is MDH planning worker protections and training on regulatory issues? The statute does not require specific protections or training, but in the Request for Applications (RFA) MDH will be requesting each manufacturer to describe how they will protect workers and what training they expect to provide. (8/11/14) Medical Cannabis Manufacturer Questions and Answers Page 4 of 10 Does the law require or prevent patients from working for a manufacturer? The law does not prevent patients from being workers nor require workers to be patients. (8/11/14) Facility Questions Why do there need to be two separate manufacturers with separate facilities? It is expensive to set up these operations. The statute requires two manufacturers. Having two independent manufacturers prevents a natural disaster, pest or fungal outbreak from eliminating the entire crop of cannabis and thus threatening the supply of cannabis to patients. (8/11/14) Explain how having two manufacturers is in the best interest of the business and patients? This structure would seem to provide no competition. The law requires that MDH register two manufacturers to produce medical cannabis in Minnesota. MDH is focused on identifying the two best manufacturers to provide medication to patients. Inquiries regarding the rationale of the structure created should be directed to the legislature. (8/11/14) Is there a cap on square footage of facilities? No. (8/11/14) Are there any alternative energy requirements? No. (8/11/14) Is the Congressional District approach to services areas the best approach given the potential density of patients in the Twin Cities? The statute directs that "distribution facilities shall be located based on geographical need throughout the state to improve patient access." (MS152.29 subdivision 1). MDH is open to other ideas and suggestions. The congressional district approach to service areas provides population balance between the two manufacturers and also ensures geographic dispersion. (8/11/14) How will MDH determine which manufacturer will be allowed to have a distribution site if each manufacturer proposes sites within the 30 -mile radius limit? This will require some discussion and negotiation between the two manufacturers and MDH. (8/11/14) How will the zoning and local approvals occur? Once a manufacturer is registered will they then need to get approval from their local municipality? MDH understands that applicants need to manage their investments prior to receiving a registration and so official zoning or other local approvals may not be in place prior to applying. That said, any approvals or recognition of support from local government entities that an applicant has obtained will be considered as part of the evaluation. (8/11/14) Does the manufacturing facility need to be in the service area assigned to the manufacturer? No, the manufacturing facility can be located anywhere in Minnesota. The distribution sites must reside in the service area assigned. (8/11/14) How does this business legislation apply to Indian reservations? — . 1 1, • .,- - -- --- r-- 1_.___1 5219CW9 11d Medical Cannabis Manufacturer Questions and Answers Page 5 of 10 American Indian reservations are sovereign nations. Any questions regarding Minnesota's medical cannabis program and how or if it applies to American Indian reservations should be directed to each tribe. (8/11/14) Health Care Practitioner Questions Can you clarify what the law means when it says there should be.no financial relationship between a manufacturer and a health care practitioner? If a health care practitioner is NOT certifying patient conditions then MDH will permit the health care practitioner to have a financial relationship with a medical cannabis manufacturer. (8/11/14) How does the program deal with doctors who decline to participate or refuse to certify a patient's condition? The statute states that physicians are not required to participate in the program (MS152.28, subdivision 1, paragraph (b)). (8/11/14) Laboratory Questions What is the timeline for the lab approval by the Commissioner? A final timeline has not been established, but we would expect Commissioner approval of the laboratories to occur in the winter or spring of 2015. (8/11/14) MDH stated that labs will need_ to be certified by 2016 but medical cannabis needs to be available in July 2015. How will that work for the labs/product testing? The process of becoming fully certified according to international standards can take up to 18 months. The statute allows the Commissioner to provisionally approve a laboratory that has not had time to become certified. The laboratory approval process will be covered in the manufacturer expedited rules. (8/11/14) Will the labs own the data that they collect when testing the products? That will be an issue that manufacturers and laboratories should address as they establish their contract. The statute only requires that lab test data be shared with the State. (8/11/14) Manufacturer Questions We have heard that some pharmacists and CPAs may not want to be involved for fear of risking licensures. Are manufacturers going to be able to get service providers and pharmacists to work with or for them? We have not surveyed pharmacists or other service providers on this issue so we have no data to validate that concern. (8/11/14) Why is the word manufacture used for both growing and manufacturing? The statute defines "Medical cannabis manufacturer" or "manufacturer" to mean an entity registered by the commissioner to cultivate, acquire, manufacture, possess, prepare, transfer, transport, supply, or dispense medical cannabis, delivery devices, or related supplies and educational materials. (8/11/14) Does the manufacturer have to be a non-profit organization or have a specific corporate structure? No, the statute does not require any specific corporate structure. (8/11/14) What if the department cancels or revokes a manufacturer's registration? Medical Cannabis Manufacturer Questions and Answers Page'6 of 10 We hope that will not happen but we will define rules on that process in either the expedited or full rules. (8/11/14) What will be the re -registration process? We are in the process of defining re -registration. (8/11/14) What if one manufacturer goes out of business? MDH does plan to develop rules for a scenario where one of the two manufacturers goes out of business. Detailed rules in this area are not likely in the expedited rules but rather these will be included in the formal rulemaking that occurs during 2015. (8/11/14) Manufacturer Application Fee Questions Comment on the $20,000 application fee. How many people are you aware of that are going to apply? Big players? Hospitals, pharmaceutical companies, etc? MDH is not aware of any hospitals, pharmaceutical companies or health care providers interested in becoming medical cannabis manufacturers. (8/11/14) Who pays the $20,000 application fee? Only the winning manufacturers, or all parties who apply? All that apply pay the non-refundable application fee. (8/11/14) Is the $20,000 application fee refunded to those who are not registered as manufacturers? No, the fee is non-refundable. This is contained in the law. (8/11/14) Manufacturer Application Questions The RFA requests identifying employees. How is an applicant supposed to have employees if they haven't been registered? The RFA does not require employees to be identified. If an applicant does know who some of the employees will be including that information would be helpful. In the absence of specific people being identified the expected qualifications of various positions can be provided. (8/11/14) Is all of the data in the application going to be public? Including any financial information provided? All of the information in the application will become public once two manufacturers have been registered with the exception of any data that has been identified as Trade Secret. (8/11/14) Should an applicant let you know if we want to give a presentation with our application? Yes, let us know if you want a presentation. MDH reserves the right to request an applicant provide a presentation even if they select not to give one. (8/11/14) Is MDH willing to travel out of state to conduct a site visit? Yes, MDH is willing to travel out of state or anywhere in-state to conduct the site visits. (8/11/14) Does the applicant need to pay for the site visit? No, the State will pay the cost for the site visits. (8/11/14) Will bonus points be awarded for residents of Minnesota? .. ... ,. i ti. • _ i r-- - �-'----� 4/7�/'�l11 it Medical Cannabis Manufacturer Questions and Answers Page 7 of 10 No, not directly. (8/11/14) Will there be any special considerations for Minnesota ownership of a manufacturer? No, not directly. (8/11/14) MDH has noted the importance of experience in growing. When you evaluate applications will you only evaluate experience growing in legal settings? All information provided in a RFA response will be considered. Claims made in the RFA should be able to be substantiated. (8/11/14) What will happen if no one is capable and/or no one applies? In the event no suitable manufacturer is registered the statute allows the Commissioner to initiate a new registration process. (8/11/14) After the RFA submission due date passes will you communicate how many applications were received? MDH will plan to provide some general information to the public regarding the progress of the evaluation and selection process. (8/11/14) How would you handle having four high scores and two low scores in different service areas? If one service area does not have any applicants that meet the minimum scoring requirements MDH may solicit new applications for just that service area. (8/11/14) Operations Questions What will the initial demand for medical cannabis be? Exact demand for July 1 will not be known until patients begin to register. In addition specific dosage and forms will not be known until pharmacists consult with patients about their condition and preferences. (8/11/14) How will unused medical cannabis be collected and disposed of The statute is silent on the issue but we expect that manufacturers will provide information in their RFA on how they will solicit, collect, handle and dispose of unused medical cannabis. (8/11/14) Is there anything that would prohibit the manufacturer from billing a patient? No. (8/11/14) Are there different meanings for the words "batch" and "lot" in the Manufacturer Medical Cannabis Rules? The manufacturers rules defines the word batch and uses it extensively. (8/11/14) Will the State define how the active ingredients should be extracted? Will there be rules about what methods can or cannot be used? MDH will not define what methods can or cannot be used to extract active ingredients from cannabis plants. Rules or guidance may be provided regarding tolerance limits for various chemicals, metals and other contaminates. (8/11/14) .. ,. i I - i r I, i O/l1L/!1AI A Medical Cannabis Manufacturer Questions and Answers Page 8 of 10 Is there a system in place if there needs to be a recall? The expedited manufacturer rules will contain some requirements associated with how adverse events should be handled. (8/11/14) Patient Questions Does the past felony rule apply to patients, to parents, to caregivers? A felony offense disqualification applies to registered designated caregivers and manufacturer employees. A patient or parent or legal guardian of a patient with a felony offense is still eligible to participate in the program. (8/11/14) Will there be a pilot program that would allow an expedited start date for catastrophically ill children? The statute does not allow for a pilot program and MDH does not have authority to initiate one on its own. (8/11/14) Do patients need to buy within their districts? No rules currently exist. It is an issue that MDH will consider and evaluate. (8/11/14) Is there an option for patients to try the products first? Testing them out in small doses? The statute only specifies that a maximum 30 day supply be distributed. Due to this a manufacturer would not be prohibited from distributing a 5 day supply for a patient. (8/11/14) What is the timeline for patient recommendations for conditions? The statute requires that the Commissioner publish a report on the existing medical and scientific literature regarding the range of recommended dosages for each qualifying condition and the range of chemical compositions ..." (MS152.25, subdivision 2) by December 1, 2014. (8/11/14) What portion of the 5000 patients are employed vs unemployed? MDH does not have detailed metrics on this but for our internal budgeting purposes we assume — 50% of patients would be enrolled in medical assistance or MinnesotaCare. (8/11/14). How many patients will there be? While the bill was being written MDH estimated that 5,000 patients will register. Actual enrollment will be impacted by a wide variety of factors. The trend in other states has been low enrollment in the first few years followed by increases. (8/11/14) Pharmacist/Pharmacy Questions Does a pharmacist need to be present at each location at time of distribution? Yes. (8/11/14) Can a pharmacy distribute medical cannabis? There is nothing in the Minnesota statute that precludes this. Pharmacies considering distributing medical cannabis would need to evaluate if doing so would violate any federal laws or regulations. (8/11/14) Product Questions Medical Cannabis Manufacturer Questions and Answers Page 9 of 10 Will only certain cannabis chemical composition be required? The statute does not specify any strains or chemical compositions that are required. However, the commissioner shall review and publicly report the existing medical and scientific literature regarding the range of recommended dosages for each qualifying condition and the range of chemical compositions of any plant of the genus cannabis that will likely be medically beneficial for each of the qualifying medical conditions. This report must be published by December 1, 2014 and updated annually. (8/11/14) How can we ensure the product is safe and tested prior to July 1, given the number of activities that must be completed: growing, extracting, creating and testing the dosages and compositions? MDH acknowledges that the timeline is tight. Based on our conversations with those in the industry the timeline, while challenging, is achievable. Should it be necessary the Commissioner can request a six month extension of the July 1, 2015 starting date. MDH does not want to have to use this if at all possible, but patient safety will be the first priority. (8/11/14) Will tincture or other medication that can be taken sublingually be allowed? Yes, a tincture is a liquid and is allowed. (8/11/14) Can the oils be used in edibles and sold at the dispensary? No, edibles are not allowed in the statute. (8/11/14) What is a pill? The standard definition of a pill is "a usually medicinal or dietary preparation in a small rounded mass to be swallowed whole" (Merriam-Webster.com). If there are questions about a formulation or design MDH would want to engage in a conversation. (8/11/14) Do you envision validation of the claims made by manufacturers? Claims made by a manufacturer should be substantiated with data. The State Health Lab does not intend to validate or substantiate claims unless there is a patient safety issue. (8/11/14) Are there restrictions on the method of ingesting the oil, liquid or pill? For example would a nasal spray be allowed? We are researching whether or not a spray is contemplated. (8/11/14) Will testing the product both at growing and after processing be necessary? It is standard practice for a manufacturer to test product throughout the growing and manufacturing process to ensure the end product meets quality standards and specifications. (8/11/14) Would you estimate a 6, 9, or 12 month shelf life? We expect manufacturers to establish their shelf'life claims. (8/11/14) Can the manufacturers act as a research facility? Can new products be developed? For example, could a manufacturer produce a topical cream as an alternative method for ingestion? This question is currently under review. (8/11/14) Statute and Rules Questions . . .. i i - i r i, 1 0 /1lL!rlA1 A Medical Cannabis Manufacturer Questions and Answers Page 10 of 10 Are the expedited rules the law? They become law once the expedited rules are accepted by the Office of Administrative Hearings and the Governor does not veto the rules. (8/11/14) What protections would there be for investors against any federal violations? The State of Minnesota cannot grant protection for investors or employees of the manufacturer against any federal charges. (8/11/14) Is there an easy way for industry to know if a requested change is a legislative change or a rule change? If the statute does not include a necessary topic, MDH lacks authority and must seek a legislative change. If a topic is included in the statute, MDH has flexibility to address it via rules. (8/11/14) 651-201-5000 Phone 888-345-0823 Toll-free Information on this website is available in alternative formats to individuals with disabilities upon request. Updated Thursday, August 21, 2014 at 02:28PM - Chapter 311 - Minnesota Session Laws Page 1 of 19 2014 Minnesota Session Laws Authenticate Key: (1) lanejuaqe 3_e be -deleted (2) new lanauaae CHAPTER 311--S.F.No. 2470 An act relating to health; providingfor medical cannabis registry program; authorizing rulemaking; establishing duties ofpatients, health care practitioners, and manufacturer of medical cannabis; establishingpatient protections; imposingpenalties; establishingfees; requiring impact assessment of medical cannabis therapeutic research, requiring audits; appropriating money; amending Minnesota Statutes 2012, sections 13.3806, by adding a subdivision; 256B.0625, subdivision 13d; proposing codingfor new law in Minnesota Statutes, chapter 152. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: Section 1. Minnesota Statutes 2012, section 13.3 806, is amended by adding a subdivision to read: Subd. 22. Medical use of cannabis data. Data collected under the iLegigry program authorized under sections 152.22 to 152.37 are governed by sections 152.25, subdivision 1. 152.25 subdivision 2; and 152.37, subdivision 3. Sec. 2. [152.221 DEFINITIONS. Subdivision 1. Applicability. For purposes of sections 152.22 to 152.37, the terms defined in this section have the meanings given them. Subd. 2. Commissioner. "Commissioner" means the commissioner of health. Subd. 3. Disqualifying felony offense. 'Disqualifying felony offense" means a violation of a state or federal controlled substance law that is a felony under Minnesota law, or would be a felony if committed in Minnesota, regardless of the sentence imposed, unless the commissioner determines that the person's conviction was for the medical use of cannabis or assisting with the medical use of cannabis. Subd. 4. Health care practitioner. "Health care practitioner" means a Minnesota licensed doctor of medicine, a Minnesota licensed physician assistant acting within the scope of authorized practice or a Minnesota licensed advanced practice registered nurse who has the primary responsibility for the care and treatment of the qualifying medical condition of person diagnosed with a qualifying medical condition. Subd. 5. Health records. "Health records" means health records as defined in section 144.291 subdivision 2, paragraph (c). Subd. 6. Medical cannabis. "Medical cannabis" means any species of the gmus cannabis plant, or anv mixture or preparation of them,_ including whole plant extracts and resins, and is delivered in the form of (1) liquid including, but not limited to, oil, (2) _pill; https://www.revisor.mn.g6v/laws/?id=311 &year=2014&type=0 8/26/2014 Chapter 311 -Minnesota Session Laws Page 2 of 19 (3) vaporized delivery method with use of liquid or oil but which does not require the use of dried leaves or plant form; or (4) any other method excluding smoking, approved by the commissioner. Subd. 7. Medical cannabis manufacturer. "Medical cannabis manufacturer" or "manufacturer" means an entity registered by the commissioner to cultivate, acquire, manufacture possess prepare transfer, transport, supply, or dispense medical cannabis, delivery devices or.related supplies and educational materials. Subd. 8. Medical cannabis product. "Medical cannabis product" means any delivery device or related supplies and educational materials used in the administration of medical cannabis for a patient with a qualifying medical condition enrolled in the registry rp og_ram. Subd. 9. Patient. "Patient" means a Minnesota resident who has been diagnosed with a qualify g medical condition by a health care practitioner and who has otherwise met any other requirements for patients under sections 152.22 to 152.37 to participate in the registnyprogram under sections 152.22 to 152.37. Subd. 10. Patient registry number. "Patient retry number" means a unique identification number assigned by the commissioner to a patient enrolled in the re ig My program. Subd. 11. Registered designated caregiver. "Registered designated caregiver" means a person who: (1) is at least 21 years old; (2) does not have a conviction for a disqualif fg elony offense; (3) has been approved by the commissioner to assist a patient who has been identified by a health care practitioner as developmentally or physically disabled and therefore unable to self-administer medication or acquire medical cannabis from a distribution facility due to the disability; and (44) is authorized by the commissioner to assist the patient with the use of medical cannabis. Subd. 12. Registry program. "RegiisDyprogram" means the patient registry established in sections 152.22 to 152.37. Subd. 13. Registry verification. "Remy verification" means the verification provided by the commissioner that a patient is enrolled in the re iga program and that includes the patient's name registry number, and qualifying medical condition and if applicable the name of the patient's registered designated caregiver or parent or legal guardian. Subd. 14. Qualifying medical condition. "Qualifying medical condition" means a diagnosis of any of the following conditions: (1)cancer,if the underlying_ condition or treatment produces one or more of the Mowing: G) severe or chronic pain; Oii) nausea or severe vomiting, or vii) cachexia or severe wasting; (2) glaucoma, https://www.revisor.mn.gov/laws/?id=311&year2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws Page 3 of 19 (3) human immunodeficiency virus or acquired immune deficiency syndrome; (4) Tourette's syndrome; (5) aMyotrohic lateral sclerosis; (6) seizures including those characteristic of epilepsy; (7) severe and persistent muscle spasms including those characteristic of multiple sclerosis,• (8) Crobn's disease; (9) terminal illness with a probable life expectancy of under one year, if the illness or its treatment pmduces one or more of the following: (i) severe or chronic pain; ii) nausea or severe vomiting; ox Viii) cachexia or severe wasting; or (10) py other medical condition or its treatment approved by the commissioner. See. 3. [152.231 LBUTATIONS. (a) Nothing in sections 152.22 to 152.37 permits any person to engage in and does not prevent the imposition of any civil criminal or other penalties for: (1) undertaking_any task under the influence of medical cannabis that would constitute negligence or professional malpractice; (2) possessing or engaging in the use of medical cannabis: (i) on a school bus or van, CH) on the grounds of any preschool or primary or secondary school; (iii) in anycorrectional facility; or (iv) on the grounds of any child care facility or home daycare; {3) vaporizing medical cannabis pursuant to section 152.22, subdivision 6: (i) on any form of public transportation; �) where the vapor would be inhaled by a nonpatient minor child; or (iii) in M public place including any indoor or outdoor area used by or open to the general public or a place of employment as defined under section 144.413, subdivision IN and (4) operating navigating or being in actual physical control of any motor vehicle, aircraft, train, or motorboat or working on transportation property equipment or facilities while under the influence of medical cannabis. (b) Nothing in sections 152.22 to 152.37 require the medical assistance and MinnesotaCare programs to reimburse an enrollee or a provider for costs associated with the medical use of cannabis. Medical assistance and MinnesotaCare shall continue to provide coverage for all services related to treatment of an enrollee's qualifying medical condition if the service is covered under chapter 256B .or 256L. Sec. 4. [152.241 FEDERALLY APPROVED CLINICAL TRIALS. The commissioner may prohibit enrollment of a patient in the regishy program if the. patient is simultaneously enrolled in a federally approved clinical trial for the treatment of https://www.revisor.mn.gov/laws/?id=311 &year=2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws Page 4 of 19 agualifLmg medical condition with medical cannabis. The commissioner shall provide information to all patients enrolled in the regisfi�program on the existence of federally approved clinical trials for the treatment of the patient's qualifying medical condition with medical cannabis as an alternative to enrollment in the patient regiis_try pro rg a.m. Sec. 5. [152.251 COMMISSIONER DUTIES. Subdivision 1. Medical cannabis manufacturer registration. a The commissioner shall register two in-state manufacturers for the production of all medical cannabis within the state by December 1, 2014, unless the commissioner obtains an adequate supply of federally sourced medical cannabis by August 1, 2014. The commissioner shall register new manufacturers or reregister the existing manufacturers by December 1 of each year, using the factors described in paragraph (c). The commissioner. shall continue to accept applications after December 1, 2014, if two manufacturers that meet the qualifications set forth in this subdivision do not apply before December 1, 2014. The commissioner's determination that no manufacturer exists to fulfill the duties under sections 152.22 to 152.37 is subject to judicial review in Ramsey County District Court. Data submitted during the application process are private data on individuals or nonpublic data as defined in section 13.02 until the manufacturer is registered under this section. Data on a manufacturer that is registered are public data, unless the data are trade secret or security information under section 13.37. N As a condition for registration, a manufacturer must agree to: (l)begin supplying medical cannabis to patients by July 1, 2015: and (2) comply with all requirements under sections 152.22 to 152.37. (c) The commissioner shall consider the following factors when determining which manufacturer to register: (1) the technical expertise of the manufacturer in cultivating medical cannabis and converting the medical cannabis into an acceptable deliver method under section 152.22, subdivision 6- (2) the qualifications of the manufacturer's employees: (3) the long-term financial stability of the manufacturer: (4) the ability to provide appropriate security measures on the premises of the manufacturer,• (5) whether the manufacturer has demonstrated an ability to meet the medical cannabis production needs required by sections 152.22 to 152.37: and (6) the manufacturer's projection and ongoing assessment of fees on patients with a qualifying medical condition. (d) The commissioner shall require each medical cannabis manufacturer to contract with an independent laboratory to test medical cannabis produced by the manufacturer. The commissioner shall approve the laboratory chosen by each manufacturer and require that the laboratory report testing results to the manufacturer in a manner determined by the commissioner. Subd. 2. Range of compounds and dosages; report. The commissioner shall review and publicly report the existing medical and scientific literature regarding the range of recommended dosages for each qualifying condition and the range of chemical compositions of any plant of the genus cannabis that will likely be medically beneficial for each of the qualifying medical conditions. The commissioner shall mare this information available to patients with qualifying medical conditions beginning December 1, 2014, and https://www.revisor.mn.gov/laws/?id=311 &year=2014&type=0 9/26/2014 , Chapter 311 - Minnesota Session Laws Page 5 of 19 update the information annually. The commissioner may consult with the independent laboratory under contract with the manufacturer or other experts in mporkin the e range of recommended dosages for each qualifying medical condition, the range of chemical compositions that will likely be medically beneficial and any risks of noncannabis drug interactions. The commissioner shall consult with each manufacturer on an annual basis on medical cannabis offered by the manufacturer. The list of medical cannabis offered by a manufacturer shall be published on the Department of Health Web site. Subd, 3. Deadlines. (a) The commissioner shall adopt rules necessary for the manufacturer to begin distribution of medical cannabis to patients under the re ig shy program by July 1 2015 and have notice of proposed rules published in the State Register prior to January 1, 2015. (b) The commissioner shall by November 1, 2014, advise the public and the cochairs of the task force on medical cannabis therapeutic research established under section 152.36 if the commissioner is unable to register two manufacturers by the December 1, 2014, deadline The commissioner shall provide a written statement as to the reason or reasons the deadline will not be met. Upon request of the commissioner, the task force shall extend the deadline by six months but may not extend the deadline more than once. Oc) If notified by a manufacturer that distribution to patients may not begin by the July 1 2015 deadline the commissioner shall advise the public and the cochairs of the task force on medical cannabis therapeutic researcb. Upon notification by the commissioner, the task force shall extend the deadline by six months, but may not extend the deadline more than once. Subd. 4. Reports. (a) The commissioner shall provide regular_ updates to the task force on medical cannabis therapeutic research regarding any changes in federal law or regulatory restrictions regarding the use of medical cannabis. (b) The commissioner may submit medical research based on the data collected under sections 152.22 to 152.37 to any federal agency with regulatory or enforcement authority over medical cannabis to demonstrate the effectiveness of medical cannabis for treating a qualifying medical condition. Sec. 6. [152.261 RULEMAKING. The commissioner mayadopt rules to implement sections 152.22 to 152.37. Rules for which notice is Published in the State Register before January 1 2015, maybe —do te using the process in section 14.389. Sec. 7. [152.271 PATIENT REGISTRY PROGRAM ESTABLISHED. Subdivision 1. Patient registry program; establishment. (a) The commissioner shall establish a patient regis rt program to evaluate data on patient demo r�aphics effective treatment options, clinical outcomes and quality -of -life outcomes for the purpose of reporting on the benefits risks and outcomes regarding patients with a qualifying medical condition engaged in the therapeutic use of medical cannabis. (b) The establishment of the registry program shall not be construed or interpreted to condone or promote the illicit recreational use of marijuana. Subd. 2. Commissioner duties. (a) The commissioner shall: (1) give notice of the program to health care practitioners in the state who are eligible to serve as health care practitioners and explain the purposes and requirements of the program https://www.revisor.mn.gov/laws/?id=311 &year=2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws Page 6 of 19 (2) allow each health care practitioner who meets or agrees to meet the program's requirements and who requests to participate, to be included in the registry program to collect data for the patient re in y; (3) provide explanatory information and assistance to each health care practitioner in understanding the nature of therapeutic use of medical cannabis within program requirements; (4) create and provide a certification to be used by a health care practitioner for the practitioner to certify whether a patient has been diagnosed with a qualifying medical condition and include in the certification an option for the practitioner to certify whether the patient in the health care practitioner's medical opinion, is developmentally or php ysically disabled and, as a result of that disability, the patient is unable to self-administer medication or acquire medical cannabis from a distribution facility; (5) ssppervise the participation of the health care practitioner in conductingap tient treatment and health records reporting in a manner that ensures stringent security and record-keeping requirements and that prevents the unauthorized release of private data on individuals as defined by section 13.02; (6) develop safety criteria for patients with a qualifying medical condition as a requirement of the patient's participation in the program, to prevent the patient from undertaking any task under the influence of medical cannabis that would constitute negligence or professional malpractice on the part of the patient; and (:Z) conduct research and studies based on data from health records submitted to the registry program and submit reports on intermediate or final research results to the legislature and major scientific journals. The commissioner may contract with a third party to complete the requirements of this clause. Any reports submitted must comply with section 152.28, subdivision 2. ('b) If the commissioner wishes to add a delivery method under section 152.22, subdivision 6 or a qualifying medical condition under section 152.22, subdivision 14, the commissioner must notify the chairs and ranking minority members of the le ' 1g1s atiye policy committees having jurisdiction over health and public safety of the addition and the reasons for its addition, including any written comments received by the commissioner from the public and any guidance received from the task force on medical cannabis research, by January 15 of the year in which the commissioner wishes to make the change. The change shall be effective on August 1 of that year, unless the legislature by law provides otherwise. Subd. 3. Patient application. (a) The commissioner shall develop a patient application for enrollment into the registryprogram The application shall be available to the patient and given to health care practitioners in the state who are eligible to serve as health care practitioners. The application must include: (11) the name, mailing address, and date of birth of the patient; (2) the name mailing address, and telephone number of the patient's health care practitioner,• (3) the name mailing address, and date of birth of the patient's designated caregiver_ if any or the patient's parent or legal guardian if the parent or legal guardian will be acting as a care 'giver; (4) a copy of the certification from the patient's health care practitioner that is dated within 90 dais prior to submitting the application which certifies that the patient has been diagnosed with a qualifying medical condition and, if applicable, that, in the health care practitioner's medical opinion, the patient is" developmentally or phsy ically disabled and, as https://www.revisor.mn.gov/laws/?id=311&year=2014&type=0 00/26/2014 Chapter 311 - Mimesota Session Laws a result of that disability, the patient is unable to self-administer medication or acquire medical cannabis from a distribution facili ; and (5) all other signed affidavits and enrolhnent forms required by the commissioner under sections 152.22 to 152 37 including but not limited to the disclosure form required under paragraph (c). (b) The commissioner shall require a patient to resubmit a copy of the certification from the patient's health care practitioner on a yearly basis and shall require that the recertification be dated within 90 days of submission. (c) The commissioner shall develop a disclosure form and require, as a condition of enrollment all patients to sign a copy of the disclosure. The disclosure must include: (1) a statement that notwithstanding any law to the contrary, the commissioner, or an employee of any state agencX may not be held civilly or criminally liable for any in M, loss of property, personal injures or death caused by M act or omission while acting within the scope of office or employment under sections 152.22 to 152.37• and (2) the patient's acknowledgement that enrollment in the patient registry program is conditional on the patienfs agreement to meet all of the requirements of sections 152.22 to 152.37. Subd. 4. Registered designated caregiver. (a) The commissioner shall register a designated caregiver for a patient if the patient's health care practitioner has certified that the patient in the health care practitioner's medical opinion, is developmentally or physically disabled and as a result of that disability, the patient is unable to self-administer medication or acquire medical cannabis from a distribution facility and the caregiver has asrreed in writing to be the patient's designated caregiver. As a condition of registration as a designated caregiver, the commissioner shall require the person to: (1) be at least 21 years of age; (2) agree to 9& possess any medical cannabis for purposes of assisting the patient; and (3) agree that if the application is approved the pi erson will not be a registered t, ered designated caregiver for more than one patient unless the patients reside in the same residence. (b) The commissioner shall conduct a criminal background check on the designated care 'ver prior to registration to ensure that the person does not have a conviction for a disqualifying felony offense AW cost of the background check shall be paid by the person seeking registration as a designated caregiver. Subd. 5. Parents or IegaI guardians. A parent or legal guardian of a patient may act as the caregiver to the patient without having to register as a designated caregiver. The parent or legal guardian shall follow all of the requirements of parents and legal guardians listed in sections 152.22 to 152.37. Nothing in sections 152.22 to 152.37 limits any legal authoritya parent or legal guardian may have for the patient under any other law. Subd. 6. Patient enrollment. (a) After receipt of a patient's application and signed disclosure the commissioner shall enroll the patient in the registry program and issue the patient and patient's registered desiggated care hig_er or parent or legal guardian if applicable a re ig_stry verification A patient's enrollment in the re istryprogram shall only be denied if the patient: (1) does not have certification from a health care practitioner that the patient has been diagnosed with a qualifying medical condition, Page 7 of 19 https://www.revisor.mn.gov/laws/?id=311 &year=2014&type=0 8/26/2014 Chapter 3 11 - Minnesota Session Laws (2) has not signed and returned the disclosure form required under subdivision 3, paragraph (c) to the commissioner, (3) does not provide the information required; (4) has previously been removed from the re igistty program for violations of section 152.30 or 152.33, or (5) provides false information. (b) The commissioner shall give written notice to a patient of the reason for denying enrollment in the re&by program. (c) Denial of enrolhnent into the registryprogram is considered a final decision of the commissioner and is subject to judicial review under the Administrative Procedure Act pursuant to chapter 14. (d) A patient's enrollment in the regoy program may only be revoked if a patient violates a requirement under section 152.30 or 152.33. (e) The commissioner shall develop a registry verification to provide to the patient, the health care practitioner identified in the patient's application, and to the manufacturer. The re i�sby verification shall include: (1) the patient's name and date of birth; (2) the patient regi try number assigned to the patient, (3) the patient's qualifying medical condition as provided by the patieni's health care practitioner in the certification; and (4) the name and date of birth of the patient's registered designated caregiver, if any, or the name of the patienfs parent or legal guardian if the parent or legal guardian will be acting as a caregiver. Subd. 7. Notice requirements. Patients and registered designated caregivers shall notify the commissioner of any address or name change within 30 days of the change having occurred A patient or registered designated caregiver is subject to a $100 fine for failure to notify the commissioner of the change. Sec. 8. R52.281 HEALTH CARE PRACTITIONER DUTIES. Subdivision 1. Health care practitioner duties. (a) Prior to a patient's enrollment in the re igistry program a health care practitioner shall: (1) determine in the health care practitioner's medical judgment whether a patient suffers from a qualifying medical condition and if so determined, provide the patient with a certification of that diagnosis; (2) determine whether a patient is developmentally or physically disabled and as a result of that disability the patient is unable to self-administer medication or acquire medical cannabis from a distribution facility and, if so determined, include that determination on the patient's certification of diagnosis; (3) advise patients registered designated caregivers and parents or legal guardians who are acting as caregivers of the existence of any nonprofit patient support Groups or organizations; (44) provide explanatory information from the commissioner to patients with qualifying medical conditions including disclosure to all patients about the experimental nature of therapeutic use of medical cannabis-, the possible risks, benefits, and side effects of the proposed treatment the application and other materials from the commissioner; and Page 8 of 19 https://www.revisor.mn.gov/laws/?id=311 &year=2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws provide patients with the Tennessen warning as required by section 13.04, subdivision 2; and (5) agree to continue treatment of the patient's qualifying medical condition and report medical findings to the commissioner. (b) Upon notification from the commissioner of the patient's enrollment in the registry program the health care practitioner shall: (1) participate in the patient registryporting system under the guidance and supervision of the commissioner; (2) report health records of the patient throughout the ongoing treatment of the patient to the commissioner in a manner determined by the commissioner and in accordance with subdivision 2• (3) determine on mealy basis if the patient continues to suffer from a qualifng medical condition and if so issue the patient a new certification of that diagnosis; and (4) otherwise comply with all requirements developed by the commissioner. (c) Nothing in this section requires a health care practitioner to participate in the registry program. Subd. 2. Data. Data collected on patients by a health care practitioner and reported to the patient regiMy are health records under section 144.291 and are private data on individuals under section 13 02 but may be used or reported in an aggregated, nonidentifiable form as part of a scientific peer-reviewed publication of research conducted under section 152.25 or in the creation of summary data, as defined in section 13.02. subdivision 19. Sec. 9. [152.291 MANUFACTURER OF MEDICAL CANNABIS DUTIES. Subdivision 1. Manufacturer; requirements. (a) A manufacturer shall operate four distribution facilities which may include the manufacturer's single location for cultivation harvesting manufacturing_ packaging, and processing but is not required to include that location A manufacturer is required to begin distribution of medical cannabis from at least one distribution fagRiy by July 1 2015. All distribution facilities must be operational and begin distribution of medical cannabis by July 1, 2016. The distribution facilities shall be located based on geographical need throughout the state to improve patient access A manufacturer shall disclose the proposed locations for the distribution facilities to the commissioner during the registration process. A manufacturer shall operate only one location where all cultivation, harvesting, manufacturing, packaging, and processing shall be conducted. Apy additional distribution facilities may dispense medical cannabis and medical cannabis products but may not contain any medical cannabis in a form other than those forms allowed under section 152.22, subdivision 6, and the manufacturer shall not conduct any cultivation harvesting, manufacturing, packaging, or processing at an additional distribution &p liV site. Any distribution facility operated by the manufacturer is subject to all of the requirements applying to the manufacturer under sections 152.22 to 152 37 including but not limited to security and distribution requirements. (b) A medical cannabis manufacturer shall contract with a laboratory, subject to the commissioner's approval of the laboratory and any additional requirements set by the commissioner, for pWoses oftesting medical cannabis manufactured by the medical cannabis manufacturer as to content contamination and consistency to verify the medical cannabis meets the requirements of section 152.22 subdivision 6. The cost of laboratory testing shall be paid by the manufacturer. Page 9 of 19 https://www.revisor.nin.gov/laws/?id=3 11 &year--2014&type--O 8/26/2014 Chapter 311 - Minnesota Session Laws Page 10 of 19 (c) The operating documents of a manufacturer must include: (1) procedures for the oversight of the manufacturer and procedures to ensure accurate record keeping; and j2) procedures for the implementation of appropriate security measures to deter and prevent the theft of medical cannabis and unauthorized entrance into areas containing medical cannabis. (d) A manufacturer shall implement security requirements, including requirements for protection of each location by a fully operational security alarm system, facility access controls perimeter inbwion detection systems and a personnel identification s s (e) A manufacturer shall not share office space with, refer patients to a health care practitioner, or have any financial relationship with a health care practitioner. W A manufacturer shall not permit anyperson to consume medical cannabis on the property of the manufacturer. (g) A manufacturer is subject to reasonable inspection by the commissioner. (h) For numoses of sections 152.22 to 152.37 a medical cannabis manufacturer is not subject to the Board of Pharmacy licensure or regulatory requirements under chapter 151. W A medical cannabis manufacturer may not employ W person who is under 21 years of age or who has been convicted of a disqualifying felony offense. An employee of a medical cannabis manufacturer must submit a completed criminal history records check consent form a full set of classifiable fingerprints, and the required fees for submission to the Bureau of Criminal Apprehension before an employee may begin working with the manufacturer. The bureau must conduct a Minnesota criminal history records check and the superintendent is authorized to exchange the fingerprints with the Federal Bureau of Investigation to obtain the applicant's national criminal history record information. The bureau shall return the results of the Minnesota and federal criminal history records checks to the commissioner. 0) A manufacturer mqy not operate in any location, whether for distribution or cultivation, harvesting manufacturing, packaong or processing, within 1,000 feet of a public or private school existing before the date of the manufacturer's registration with the commissioner. Uk A manufacturer shall comply with reasonable restrictions set by the commissioner relating to signage marketing display, and advertising of medical cannabis. Subd. 2. Manufacturer; Production. ((a) A manufacturer of medical cannabis shall provide a reliable and ongoing supply of all medical cannabis needed for the registry program. (b) All cultivation, harvesting, manufacturing_ packaging and processing of medical cannabis must take place in an enclosed locked facility at a physical address provided to the commissioner duringthe he registration process. (c) A manufacturer must process and prepare any medical cannabis plant material into a form allowable under section 152.22 subdivision 6, prior to distribution of any medical cannabis. Subd. 3. Manufacturer; distribution. (a) A manufacturer shall require that emplovees licensed as pharmacists_pursuant to chapter 151 be the only employees to distribute the medical cannabis to a patient. (b) A manufacturer may dispense medical cannabis products, whether or not the products have been manufactured by the manufacturer, but is not required to dispense medical cannabis products. hos://www.revisor.mn.gov/laws/?id=311&year=2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws Page 11 of 19 (c) Prior to distribution of any medical cannabis, the manufacturer shall: (1) verify that the manufacturer has received the registry verification from the commissioner for that individual patient; (2) verify that the person reguesiing_the distribution of medical cannabis is the patient the patient's registered designated caregiver, or the patient's parent or legal guardian listed in the registry verification using the procedures described in section 152.11, subdivision 2d; (3) assign a tracking number to any medical cannabis distributed from the manufacturer,• (4) ensure that any employee of the manufacturer licensed as a pharmacist pursuant to chapter 151 has consulted with the patient to determine the proper dosage for the individual patient after reviewing the ranges of chemical compositions of the medical cannabis and the ranges of proper dosages reported by the commissioner; (5) properly package medical cannabis in compliance with the United States Poison Prevention Packing Act regarding child resistant packaging and exemptions for packaging for elderly patients and label distributed medical cannabis with a list of all active ingredients and individually identifying information, including_ 0 the patient's name and date of birth; Cli) the name and date of birth of the patient's registered designated caregiver or, if listed on the regnatU verification, the name of the patient's parent or legal guardian, if Ugh cable-, (iii) the patient's re ig_stry identification number; (iv) the chemical composition of the medical cannabis; and (v) the dosage; and (6) ensure that the medical cannabis distributed contains a maximum of a 30 -day spV& of the dosage determined for that patient. ) A manufacturer shall require any employee of the manufacturer who is transporting medical cannabis or medical cannabis products to a distribution facility to carry identification showing that the person is an employee of the manufacturer. Subd. 4. Report. Each manufacturer shall report to the commissioner on a monthly basis the following information on each individual patient for the month prior toothe reprt: (1) the amount and dosages of medical cannabis distributed; (2) the chemical composition of the medical cannabis, and ) the tracking number assigned to any medical cannabis distributed. Sec. 10. 1152.301 PATIENT DUTIES. AZA patient shall apply to the commissioner for enrollment in the registry program by submitting an application as required in section 152.27 and an annual registration fee as determined under section 152.35. (b) As a condition of continued enrollment, patients shall a egr a to: (1) continue to receive regularly scheduled treatment for their qualifying medical condition from their health care practitioner; and Q report changes in their qualifying medical condition to their health care practitioner.. https://www.revisor.mn.gov/laws/?id=311&year--2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws Page 12 of 19 ,(c)patient shall only receive medical cannabis from a registered manufacturer but is not required to receive medical cannabis products from only a registered manufacturer. Sec. 11. (152.311 DATA PRACTICES. (a) Government data in patient files maintained by the commissioner and the health care practitioner, and data submitted to or by a medical cannabis manufacturer, are private data on individuals as defined in section 13 02 subdivision 12 or nonpublic data, as defined in section 13 02 subdivision 9 but may be used for purposes of complying with chapter 13 and complying with a request from the legislative auditor or the state auditor in the performance of official duties The provisions of section 13.05 subdivision 11, apply to a registration agreement entered between the commissioner and a medical cannabis manufacturer under section 152.25. (b) Not public data maintained by the commissioner may not be used for any purpose not provided for in sections 152.22 to 152 37 and may not be combined or linked in any manner with any other list dataset, or database. Sec. 12. R52.321 PROTECTIONS FOR REGISTRY PROGRAM PARTICIPATION. Subdivision 1. Presumption. (a) There is a presumption that a patient enrolled in the registry program under sections 152.22 to 152.37 is engaged in the authorized use of medical cannabis. (b) The presumption may be rebutted by evidence that conduct related to use of medical cannabis was not for the purpose of treating or alleviating the patient's qualifying medical condition or symptoms associated with the patient's qualifying medical condition. Subd. 2. Criminal and civil protections. (a) Subject to section 152.23, the following are not violations under this chapter: (1) use or possession of medical cannabis or medical cannabis products by a patient enrolled in the registry program or possession byregistered designated caregiver or the parent or legal guardian of a patient if the parent or legal guardian is listed on the registry . verification; (2) possession, dosage determination or sale of medical cannabis or medical cannabis products by a medical cannabis manufacturer employees of a manufacturer, a laboratory conducting testing on medical cannabis oremployees of the laboratory; and (3Zpossession of medical cannabis or medical cannabis products by any person while carrying out the duties required under sections 152.22 to 152.37. Cb) Medical cannabis obtained and distributed pursuant to sections 152.22 to 152.37 and associated property is not subject to forfeiture under sections 609.531 to 609.5316. (c) The commissioner, the commissioner's staff, the commissioner's agents or contractors and any health care practitioner are not subject to. any civil or disciplinary penalties by the Board of Medical Practice the Board of Nursing, or by any business, occupational or professional licensing board or entity solely for the participation in the rregl9l program under sections 152.22 to 152.37. A pharmacist licensed under chapter 151 isnot subject to any civil or disd iinM penalties by the -Board of Pharmacy when acting in accordance with the provisions of sections 152.22 to 152.37. Nothing in this section affects a professional licensing board from taking action in response to violations of any other section of law. (d) Notwithstanding any law to the contrary the commissioner, the governor of Minnesota or an employee of any state agency may not be held civilly or criminally liable httos://www.revisor.mn.gov/laws/?id=311&year=2014&type=0 8/26/2014 -Chapter 311 - Minnesota Session Laws for any injury loss of property, personal injiuy or death caused by any act or omission while acting within the scope of office or employment under sections 152.22 to 152.37. (e) Federal state and local law enforcement authorities are prohibited from accessing the patient registry under sections 152.22 to 152.37 except when acting pursuant to a valid search warrant. (fl Notwithstanding any law to the contrary, neither the commissioner nor a public employee may release data or information about an individual contained in any report, document or registry created under sections 152.22 to 152.37 or any information obtained about a patient participating in the program except as provided in sections 152.22 to 152.37. (g) No information contained in a reportdocument, registry, or obtained from a patient under sections 152.22 to 152.37 may be admitted as evidence in a criminal proceeding unless independently obtained or in connection with a proceeding; involving a violation of sections 152.22 to 152.37. (h) Notwithstanding section 13.09 any person who violates paragr aph (e) or (fl is guifty of a gross misdemeanor. (i) An attorney may not be subject to disciplinary action by the Minnesota Supreme Court or professional res_ponsibiljty board for providing legal assistance to prospective or registered manufacturers or others related to activity that is no longer subject to criminal penalties under state law pursuant to sections 152.22 to 152.37. 0) Possession of a retry verification or application for enrollment in the program by a person entitled to possess or apply for enrolhnent in the registry program does not constitute probable cause or reasonable suspicion, nor shall it be used to support a search of the person or pro�ertyof the person possessing or applying for the re ig as verification, or otherwise subject the person or property of the person to inspection by any governmental agency. Subd. 3. Discrimination prohibited. (a) No school or landlord may refuse to enroll or lease to and may not otherwise Penalize a person sol eIXfor the person's status as a patient enrolled in the registry progLam under sections 152.22 to 152.37, unless failing to do so would violate federal law or regulations or cause the school or landlord to lose a monetary or licensing_related benefit under federal law or re ations. (b) For the purposes of medical care including organ transplants, a registry program enrollee's use of medical cannabis under sections 152.22 to 152.37 is considered the equivalent of the authorized use of any other medication used at the discretion of a physician and does not constitute the use of an illicit substance or otherwise disqualify a patient from needed medical care. (c) Unless a failure to do so would violate federal law or regulations or cause an employer to lose a monetgy or licensing -related benefit under federal law or regulations, an employer may not discriminate against a person in hiring termination, or any term or condition of employment or otherwise penalize a person, if the discrimination is based upon either of the following: (1) the person's status as apatient enrolled in the regisfty program under sections 152.22 to 152.37; or (2) a patient's positive dM test for cannabis components or metabolites unless the patient used, possessed or was impaired by medical cannabis on the premises of the place of employment or during the hours of employment. (d) An employee who is rugured to undergo employer dragtesting esting pursuant to section 181.953 May present verification of enrollment in the patient re ig Au as part of the employee's explanation under section 181.953, subdivision 6. Page 13 of 19 httDs://www.revisor.mn.gov/laws/?id=31 I &year=2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws Page 14 of 19 (e) A person shall not be denied custody of a minor child or visitation rights or parenting time with a minor child solely based on the person's status as a patient enrolled in the regjgW program under sections 152.22 to 152.37. There shall be no presum tip 'on of neglect or child endangerment for conduct allowed under sections 152.22 to 152.37, unless the person's behavior is such that it creates an unreasonable danger to the safety of the minor as established by clear and convincing evidence. Sec. 13. [152.331 VIOLATIONS. Subdivision 1. Intentional diversion; criminal penalty. In addition to any other applicable penalty in law, a manufacturer or an agent of a manufacturer who intentionally transfers medical cannabis to a person other than a patient, a registered designated caregiver or, if listed on the registry verification, a parent or legal guardian of a patient is guilty of a felony punishable by_mlpn nment for not more than two years or by payment of a fine of not more than $3,000, or both. A person convicted under this subdivision may not continue to be affiliated with the manufacturer and is disqualified from further participation under sections 152.22 to 152.37. Subd. 2. Diversion by patient, registered designated caregiver, or parent; criminal penalty, In addition to= other applicable penalty in law, a patient, re 'sgi tered designated caregiver or, if listed on the registry verification, a parent or legal guardian of a patient who intentionally sells or otherwise transfers medical cannabis to a person other than a patient designated registered caregiver or, if listed on the registry verification, a parent or legal guardian of a patient is guilty of a felony punishable by imprisonment for not more than two years or by pUment of a fine of not more than $3,000, or both. Subd. 3. False statement, criminal penalty, A person who intentionally makes a false statement to a law enforcement official about any fact or circumstance relatin to o the medical use of cannabis to avoid arrest or prosecution is grapy of a misdemeanor Mum by imprisonment for not more than 90 days or by payment of a fine of not more than $1 000 or both. The penalty is in addition to any other penalties that may apply for making a false statement or for the possession, cultivation, or sale of cannabis not protected by sections 152.22 to 152.37. If a person convicted of violating this subdivision is a patient or a registered designated caregiver, the person is disqualified from further participation under sections 152.22 to 152.37. Subd. 4. Submission of false records, criminal penalty, A person who knowingly submits false records or documentation required by the commissioner to register as a manufacturer of medical cannabis under sections 152.22 to 152.37 is guilty of a felony and may be sentenced to imprisonment for not more than two years or bypayment of a fine of not more than $3,000, or both. Subd. 5. Violation by health care practitioner; criminal penalty, A health care practitioner who knowingly refers patients to a manufacturer or to a designated caregiver, who advertises as a manufacturer, or who issues certifications while holding a financial interest in a manufacturer is guilty of a misdemeanor and may be sentenced to imprisonment for not more than 90 days or by payment of a fine of not more than $1,000, or both. Subd. 6. Other violations; civil penalty. A manufacturer shall be fined up to $1,000 for any violation of sections 152.22 to 152.37 or the regulations issued pursuant to them where no penalty has been specified. This penalty is in addition to any ocher applicable penalties in law. https://www.revisor.mn.gov/laws/?*id=311&year--2014&type--O 8/26/2014 Chapter 311 - Minnesota Session Laws Sec. 14. 1152.341 NURSING FACILITIES. Nursing facilities licensed under chapter 144A boarding care homes licensed under section 144 50 and assisted living facilities may adopt reasonable restrictions on the use of medical cannabis by a patient enrolled in the registry program who resides at the facility. The restrictions may include a provision that the facility will not store or maintain the patient's supply of medical cannabis that the facility is not responsible for providing the medical cannabis for patients and that medical cannabis be used only in a place specified by the facility Nothing contained in this section shall require the facilities to adopt such restrictions and no facility shall unreasonably limit a patient's access to or use of medical cannabis to the extent that use is authorized by the patient under sections 152.22 to 152.37. Sec. 15. 1152.351 FEES; DEPOSIT OF REVENUE. (a) The commissioner shall collect an enrollment fee of $200 from patients enrolled under this section If the patient attests to receiving Social Security disability, Supplemental Security Insurance payments or being enrolled in medical assistance or MinnesotaCare, then the fee shall be $50 The fees shall be payable annually and are due on the anniversary date of the patient's enrollment The fee amount shall be deposited in the state trea,TU and credited to the state government special revenue fund. (b) The commissioner shall collect an application fee of $20,000 from each entity submitting an qpplication for registration as a medical cannabis manufacturer. Revenue from the fee shall be deposited in the state treasury and credited to the state government special revenue fund. (c) The commissioner shall establish and collect an annual fee from a medical cannabis manufacturer equal to the cost of rewAting_and inspecting the manufacturer in that year. Revenue from the fee amount shall be deposited in the state treasury and credited to the state government special revenue fund. (d) A medical cannabis manufacturer may charge patients enrolled in the registry program a reasonable fee for costs associated with the operations of the manufacturer. The manufacturer may establish a sliding Scale of patient fees based upon a patient's household income and may accept private donations to reduce patient fees. Sec. 16. [152.361 IWACT ASSESSMENT OF MEDICAL CANNABIS THERAPEUTIC RESEARCH. Subdivision 1. Task force on medical cannabis therapeutic research. a A 23 - member task force on medical cannabis therapeutic research is created to conduct an impact assessment of medical cannabis therapeutic research. The task force shall consist of the following members: (1) two members of the house of representatives one selected by the speaker of the house the other selected by the minority leader; �2) two members of the senate one selected by the majod1y leader, the other selected by the DIWority leader; (3) four members representing consumers or patients enrolled in the registry program, including at least two parents of patients under age 18; (4) four members representing health care providers including one licensed pharmacist,• Page 15 of 19 httos://www.revisor.mn.gov/laws/?id=311&year=2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws (5) four members representing law enforcement, one from the Minnesota Chiefs of Police Association, one from the Minnesota Sheriff s Association, one from the Minnesota Police and Peace Officers Association, and one from the Minnesota County Attorneys Association-, (6) four members representing substance use disorder treatment providers; and (7) the commissioners of health, human services, and public safety. Task force members listed under para aph (a), clauses (3)(4),(5), and (6),hall be appointed by the governor under the appointment process in section 15.0597. Members shall serve on the task force at the pleasure of the appointing authority. All members must be appointed by July 15 2014 and the commissioner of health shall convene the first meeting of the task force by August 1, 2014. (c) There shall be two cochairs of the task force chosen from the members listed under paragraph (a) One cochair shall be selected by the speaker of the house and the other cochair shall be selected by the majority leader of the sensate. The authority to convene meetings shall alteinate between the cochairs. (d) Members of the task force other than those in para rP (a), clauses (1), (2), and (7) shall receive expenses as provided in section 15.059, subdivision 6. Subd. 2. Impact assessment. The task force shall hold hearings to conduct an assessment that evaluates the impact of the use of medical cannabis and evaluates Minnesota's activities and other states' activities involving medical cannabis, and offer analysis of: (1) program design and implementation; (2) the impact on the healthcare provider community; (3 patient experiences; (4) the impact on the incidence of substance abuse; (5„) access to and quality of medical cannabis and medical cannabis products; (66) the impact on law enforcement and prosecutions; (7) public awareness and perception; and (8) any unintended consequences. Subd. 3. Cost assessment. By January 15 of each year, beginning January 15,201-5 and endingJanuary 15 2019 the commissioners of state departments impacted by the medical cannabis therapeutic research study shall report to the cochairs of the task force on the costs incurred by each department on implementing sections 152.22 to 152.37. The reports must compare actualcosts to the estimated costs of implementing these sections and must be submitted to the task force on medical cannabis therapeutic research. Subd. 4. Reports to the legislature. (a) The cochairs of the task force shall submit the following reports to the chairs and ranking minority members of the legislative committees and divisions with jurisdiction over health and human services, public safety, judiciary, and civil law: (1) by February 1 2015 a report on the design and implementation of the registry program• and every two years thereafter a complete impact assessment report; and (2) upon receipt of a cost assessment from a commissioner of a state agency, the completed cost assessment. (b) The task force may make recommendations to the legislature on whether to add or remove conditions from the list of qualifying medical conditions. Page 16 of 19 https://www.revisor.mn.gov/laws/?id=311&yeax=2014&type=0 8/26/2014 . Chapter 311 - Minnesota Session Laws Subd. 5. No expiration, The task force on medical cannabis therapeutic research does not expire. Sec. 17. 1152.371 FINANCIAL EXANUNATIONS; PRICING REVIEWS. Subdivision 1. Financial records. A medical cannabis manufacturer shall maintain detailed financial records in a manner and format approved by the commissioner, and shall keep all records updated and accessible to the commissioner when requested. Subd. 2. Certified annual audit. A medical cannabis manufacturer shall submit the results of an annual certified financial audit to the commissioner no later than May 1 of each year. The annual audit shall be conducted by an independent certified public accountant and the costs of the audit are the responsibility of the medical cannabis manufacturer. Results of the audit shall be provided to the medical cannabis manufacturer and the commissioner. The commissioner may also require another audit of the medical cannabis manufacturer by a certified public accountant chosen by the commissioner with the costs of the audit paid by the medical cannabis manufacturer. Subd. 3. Power to examine. (a) The commissioner or desi egn e may examine the business affairs and conditions of any medical cannabis manufacturer, including but not limited to a review of the financing budgets revenues, sales, and pricing. (b) An examination may cover the medical cannabis manufacturer's business affairs, practices and conditions including but not limited to a review of the financing budgets, revenues sales andpricing The commissioner shall determine the nature and scope of each examination and in doing so shall take into account all available relevant factors concerning the financial and business affairs practices, and conditions of the examinee. The costs incurred by the department in conducting an examination shall be paid for by the medical cannabis manufacturer. (c) When making an examination under this section, the commissioner may retain attorneys appraisers independent economists independent certified public accountants, or other professionals and specialists as designees. A certified public accountant retained by the commissioner may not be the same certified public accountant providing the certified annual audit in subdivision 2. (d) The commissioner shall make a report of an examination conducted under this section and provide a copy to the medical cannabis manufacturer. The commissioner shall then post a copy of the report on the department's Web site. All working_ papers, recorded information., documents and copies produced by obtained by or disclosed to the commissioner or an other person in the course of an examination, other than the information contained in any commissioner official report, made under this section are private data on individuals or nonpublic data, as defined in section 13.02. Sec. 18. Minnesota Statutes 2012, section 256B.0625, subdivision 13d, is amended to read: Subd. 13d. Drug formulary. (a) The commissioner shall establish a drug formulary. Its establishment and publication shall not be subject to the requirements of the Administrative Procedure Act, but the Formulary Committee shall review and comment on the formulary contents. (b) The formulary shall not include: (1) drugs, active pharmaceutical ingredients, or products for which there is no federal funding; Page 17 of 19 https://www.revisor.mn.gov/laws/?id=311 &year=2014&type=0 8/26/2014 Chapter 311 - Minnesota Session Laws (2) over-the-counter drugs, except as provided in subdivision 13; (3) drugs or active pharmaceutical ingredients used for weight loss, except that medically necessary lipase inhibitors may be covered for a recipient with type IT diabetes; (4) drugs or active pharmaceutical ingredients when used for the treatment of impotence or erectile dysfunction; (5) drugs or active pharmaceutical ingredients for which medical value has not been established; and (6) drugs from manufacturers who have not signed a rebate agreement with the Department of Health and Human Services pursuant to section 1927 of title XIX of the Social Security Act.-; and (7) medical cannabis as defined in section 152.22, subdivision 6. (c) If a single -source drug used by at least two percent of the fee-for-service medical assistance recipients is removed from the formulary due to the failure of the manufacturer to sign a rebate agreement with the Department of Health and Human Services, the commissioner shall notify prescribing practitioners within 30 days of receiving notification from the Centers for Medicare and Medicaid Services (CMS) that a rebate agreement was not signed. Sec. 19. [152.2611 RULES, ADVERSE INCIDENTS. (a) The commissioner of health shall adopt rules to establish requirements for reporting incidents when individuals who are not authorized to possess medical cannabis under Minnesota Statutes sections 152.22 to 152.37, are found in possession of medical cannabis. The rules must identifyprofessionals required to report, the information they required to reportand actions the reporter must take to secure the medical cannabis. (b) The commissioner of health shall adopt rules to establish requirements for law enforcement officials and healthcare professionals to report incidents involving an overdose of medical cannabis to the commissioner of health. (c) Rules must include the method by which the commissioner will collect and tabulate reports of unauthorized possession and overdose. Sec. 20. INTRACTABLE PAIN. The commissioner of health shall consider the addition of intractable pain, as defined in Minnesota Statutes, section 152.125, subdivision 1 to the list ofgudji dng medical conditions under Minnesota Statutes section 152 22 subdivision 14 prior to the consideration of any other new qualifying medical conditions. The commissioner shall report findings on the need for adding intractable pain to the list of gualifjAg medical conditions to the task force established under Minnesota Statutes section 152.36, no later than Julyl, 2016. Sec. 21. APPROPRIATIONS; MEDICAL CANNABIS RESEARCH. Subdivision 1. Health Department. $2,795,000 is appropriated in fiscal year 2015 from the general fund to the commissioner of health for the costs of administering Minnesota Statutes sections 152.22 to 152.37. The base for this appropriation is $829,000 in fiscal year 2016 and $728,000 in fiscal year 2017. Subd. 2. Legislative Coordinating Commission. $24,000 is appropriated in fiscal ear 2015 from the general fund to the Legislative Coordinating Commission to administer the task force on medical cannabis therapeutic research under Minnesota Statutes, section 152.36, and for the task force to conduct the impact assessment on the use of cannabis for medicinal purposes. Page 18 of 19 https://www.revisor.mn.gov/laws/lid=311&year=2014&type=0 8/26/2014 A Chapter 311 - Minnesota Session Laws Page 19 of 19 Subd. 3. Health Department. $100,000 is appropriated in fiscal year 2015 from the e state government special revenue fund to the commissioner of health for the costs of implementing Minnesota Statutes, sections 152.22 to 152.37. The base for this appropriation is $834,000 in fiscal year 2016 and $729,000 in fiscal year 2017. See. 22. EFFECTIVE DATE. Sections 1 to 21 are effective the day following final enactment. Presented to the governor May 17, 2014 Signed by the governor May 29, 2014, 8:56 a.m. V Copyright n 2014 by the Office of the Revisor of Statutes, State of Minnesota. All rights reserved. https://www.revisor.mn.gov/laws/?id=311&year=2014&type=0 8/26/2014 CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014. Ch 311 4770.0100 APPLICABILITY AND PURPOSE. 4770.0200 DEFINITIONS 4770.0300 DUTIES OF COMMISSIONER. 4770.0400 MEDICAL CANNABIS MANUFACTUER; OPERATIONS. 4770 0500 MEDICAL CANNABIS MANUFACTURER; SAWING; STABILITY TESTING. 4770.0600 PERMITTING AND LOCATION. 4770.0700 HOURS OF OPERATION; ACCESS. 4770.0800 ADVERTISING AND MARKETING. 4770 0900 MONITORING AND SURVEILLANCE REQUIREMENTS. 4770.1000 ALARM SYSTEM REQUIREMENTS. 4770.1100 TRANSPORTATION OF MEDICAL CANNABIS. 4770.1200 DISPOSAL OF MEDICAL CANNABIS AND PLANT MATERIAL, 4770.1300 MANDATORY SIGNAGE. 4770.1400 PERSONNEL IDENTIFICATION SYSTEM. 4770 1500 CLOSURE OF OPERATIONS; DEREGISTRATION. 4770.1600 RECORD KEEPING; REQUIREMENTS. 4770 1700 MEDICAL CANNABIS MANUFACTURER; PRODUCTION REQUIREMENTS. 4770 1800 MEDICAL CANNABIS MANUFACTURER; DISTRIBUTION PROTOCOLS; DISTRIBUTION FACILITY. 4770.1900 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM. 4770 2000 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM.; APPLICATION. Rev. 07/31/2014 Page 1 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS RE, GISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 4770.2100 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; COMMISSIONER APPROVAL OR DENIAL. 4770.2200 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; LIST OF APPROVED LABS. 4770.2300 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM: VOLUNTARY WITHDRAWAL OF APPROVAL. 4770.2400 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM: DUTY TO NOTIFY. 4770.2500 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM: APPEAL OF ADMINISTRATIVE DECISION. 4770.2600 MEDICAL CANNABIS MANUFACTURER; FINANCIAL EXAMINATIONS; PRICING REVIEWS. Rev. 07/31/2014 Page 2 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.rees@state.mn,us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 4770.0100 APPLICABILITY AND PURPOSE. The commissioner shall enforce the provisions relating to the registration and oversight of a medical cannabis manufacturer under Minnesota Statutes, section 152.22 to 152.37. 4770.0200 DEFINITIONS. Subpart 1 Acceptable performance or acceptable results. "Acceptable performance" or "acceptable results" means analytical test results generated by a laboratory using methods as specified in parts XXXX that acceptable and allowed by the approved provider. Subp 2 Applicability. The terms used in this chapter have the meaning given them in this part and in Minnesota Statutes sections 152.22 through 152.37. Subp 3 Applicant "Applicant" means any corporation limited liability company, association or partnership limited liability partnership or one or more individuals, principal officers agency, business trust estate trust or any other legal entity that is applying to the commissioner for registration as a medical cannabis manufacturer under Minnesota Statutes, section 152.25, subdivision 1. Subp 4 Approval "Approval" means acknowledgment by the commissioner that a laboratory has the policies personnel validated procedures and practices to produce reliable data in the analysis of analytes and contaminants described in part XXXX. Subp 5 Approved provider. "Approved provider" means aprovider of performance testing_ samples that the commissioner has determined: (1) provides an adequate volume of samples to perform statistically valid analyses; (2) calculates the number of standard deviations of the mean allowed using the results of all labs submitting test results after the exclusion of outlying values; and (3) allows a range of standard deviations of the mean no less stringent than the range allowed by the General Requirements for the competency of reference material Rev. 07/31/2014 All Content Subject to Change Page 3 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 producers in ISO Guide 34 Subp. 6. Audit. "Audit" means a fmancial review by an independent certified public accountant that includes select scope engagement or other methods of review that analyze operational or compliance issues. Subp. 7. Batch. "Batch" means a specific quantity that is uniform and intended to meet specifications for identity, strength purity and composition and that is manufactured packaged and labeled during a specified time period according to a single manufacturing, packaging and labeling batch record. Subp. 8. Batch number. "Batch number" means a unique numeric or alphanumeric identifier assigned to a batch by a manufacturing facility when the batch is first planted. The batch number must contain the manufacturingfacilitynumber and a sequence to allow for inventory and traceability. Subp. 9. Biosecurity. `Biosecurity" means a set of preventative measures designed to reduce the risk of transmission of infectious diseases in crops quarantined pests invasive alien species, and living modified organisms. Subp. 10. Cannabis. "Cannabis" has the meaning given in Minnesota Statutes section 152.01, subdivision 9. Subp. 11. Cannabis waste. "Cannabis waste" means M part of the cannabis plant that is not usable [cannabis], or plant material that cannot be processed into a form allowable under Minnesota Statutes, section 152.22, subdivision 6. Subp. 14. Certified financial audit. "Certified financial audit" means the annual fmancial audit required under Minnesota Statutes, section 152.37, subdivision 2. Subp. 15. Commissioner. "Commissioner" means the commissioner of the department of health or the commissioner's designee. Rev. 07/3112014 Page 4 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 Subp 16 Current photograph "Current photograph" means an electronic image of an individual f ...1 Subp 17 Disqualifying felony offense "Disqualifying felony offense" has the meaning given in Minnesota section 152.22, subdivision 3. Subp 18 "Distribute" or "distribution". "Distribute" or "distribution" means the delivery of medical cannabis to a patient parent or legal guardian or registered care giver that is packaged in a suitable container qppropriately labeled for subsequent administration to or use by aapatient who is participating in the registry program and who is authorized to receive medical cannabis . Subp 19 Distribution facility. "Distribution facility" means any building or grounds of a medical cannabis manufacturer where the sale and distribution of medical cannabis are authorized and the production of medical cannabis is prohibited. A distribution facility may be part of a manufacturing facility and any distribution facility not on the same property as a manufacturing facility is prohibited from performing_any production activities. Subp 20 Diversion "Diversion" means the intentional sale or transfer of medical cannabis to a person other than a patient designated registered caregiver or a parent or legal guardian of a patient if the parent or legal guardian of a patient is listed on the registry verification." Subp 21 Enclosed, locked facility. "Enclosed locked facility" means a room, greenhouse building or other enclosed area equipped with locks or other security devices that permit access only by a medical cannabis manufacturer employee to cultivate, store, and distribute medical cannabis [See Laws 2014 chapter 311 s 9 [152.291, subd 2.1 Subp 24 Field of Testing "Field of Testing" means the combination of product type and analyte for which a laboratory has applied or received approval by the commissioner. Subp 25 Financial interest "Financial interest" means any actual or future right to ownership investment or compensation arrangement with another person, either directly or Rev. 0713112014 Page 5 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 indirectly, through business, investment or spouse, .parent or child in a medical cannabis manufacturer. Financial interest does not include ownership of investment securities in a publicly -held corporation that is traded on a national exchange or over-the-counter market, provided the investment securities held by the person, the person's spouse, parent or child, in the aggregate, do not exceed one per cent ownership in the medical cannabis manufacturer. Subp. 26. Health care practitioner. "Health care practitioner" has the meaning given in Minnesota Statutes, section 152.22, subdivision 4. Subp. 27. Inspection. "Inspection" an on-site evaluation of laboratory facilities, records, personnel, equipment, methodology, and quality assurance practices by the commissioner for compliance with the applicable provisions of this chapter. Subp: 28. International Standards Organization or ISO. The "International Standards Organization" is an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards. Subp. 29. Intrastate. "Intrastate" means existing or occurring within the state boundaries of Minnesota. Subp. 30. Laboratory managing agent. "Laboratory managing agent" means a person, as defined in Minnesota Statutes, section 326.71, subdivision 8, who is legally authorized to direct the activities of the laboratory and commit the appropriate resources to comply with parts Subp. 31. Label. "Label" means a display of written, printed or graphic matter upon the immediate container of any product containing medical cannabis. Subp. 32. Laboratory. "Laboratory" means fixed -based or mobile, a person, corporation, or other entity, including a government or tribal entity, that examines, analyzes or tests samples. Subp. 33. Laboratory owner. "Laboratory owner means" a person who: Rev. 07/3112014 Page 6 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 A. is a soleproprietor of a laboratory; B. holds a partnership interest in a laboratory; or C. owns five percent or more of the shares in a corporation that owns a laboratory Subp 34 Laboratory technical manager. "Laboratory Technical Manager" means a person who is scientifically responsible to ensure the achievement and maintenance of Quality and analtical standards of practice and who is in a supervisory, lead worker, or similarly named positions within an organization. Subp 35 Manufacturing facility. "Manufacturing facility" means any secured building, space grounds and physical structure of a medical cannabis manufacturer for the production, cultivation harvesting, manufacturing packaging, and distribution of medical cannabis and where access is restricted to designated employees of a medical cannabis manufacturer. f See Laws 2014 chaqpter 311, s 9 (152.291, subd 1.1 Subp 37 Medical cannabis "Medical cannabis" has the meaning given in Minnesota section 152.22. subdivision 6. Subn 38 Medical cannabis manufacturer. "Medical cannabis manufacturer" has the meaning given in Minnesota section 152.22, subdivision 7. Subp 39 Medical cannabis product "Medical cannabis product" has the meaning given in Minnesota section 152.22, subdivision 8." Subp 40 Monitoring "Monitoring" means the continuous and uninterrupted video surveillance of manufacturing activities and oversight for potential suspicious actions. Monitoring through video surveillance includes the purpose of summoning a law enforcement officer to the premises during alarm conditions. Subp, 41 Parent or legal guardian "Parent or legal guardian" has the meaning given in Minnesota Statutes section 152.27, subd. 5. Rev. 0713112014 Page 7 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 Sirhp. 42. Patient. "Patient" has the meaning given in Minnesota Statutes, section 152.22, subdivision 9." Subp. 43. Patient registry identification number. "Patient registry identification number" means [... I See Laws 2014, chapter 311, s 9 [152.291, subd 3 (5) Subp. 44. Person. "Person" means an individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, state or political subdivision of a state, or a legal successor, representative, agent, or agency of the foregoing. Person does not include federal government agencies. Subp. 45. Plant material. "Plant material" means any cannabis plant, cutting, trimming or clone that has roots or that is cultivated with the intention of growing roots. Subp. 46 "Principal officer" includes a prospective medical cannabis manufacturer or medical cannabis manufacturer owner, president, vice president, secretary, treasurer, partner, officer, board member, shareholder or person involved in a profit sharing _arran arrangement. Subp. 47. Production or produce. "Production" or "produce" means the manufacture, planting, preparation, cultivation,rig, harvesting, pg_ ropagation, compounding, conversion, or natural processing or manufacturing of cannabis, either directly or indirectly y extraction from substances of natural origin, or independently y means of chemical synthesis, or by combination of extraction and chemical synthesis, and includes any packaging or repackaging_of the substance or labeling or relabeling of its container. Subp. 48. Proficiency Testing Sample or PT Sample. "Proficiency Testing Sample or PT Sample" means a sample obtained from an approved provider to evaluate the ability of a laboratory to produce an analytical test result meeting the defmition of acceptable performance. The concentration of the analyte in the sample is unknown to the laboratory at the time of analysis. Rev. 0713112014 All Content Subject to Change Page 8 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 Subp. 49. Manufacturing -or manufacture: "Manufacturing" or "manufacture" means - the process of converting harvested cannabis plant material into a finished product by manual labor and/or machinery designed to meet a specific need or customer expectation, either directly or indirectlyby extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis. Subp. 50. Registry verification. "Registry verification" has the meaningivy en in Minnesota section 152.22, subdivision 14." Subp. 51. Registration agreement. "Registration agreement" means the document issued by the commissioner under Minnesota Statutes, section 152.31 that authorizes the operation of a medical cannabis manufacturer for a specified period of time. Subp. 52. Registered. "Registered" means licensed, permitted, or otherwise certified by the commissioner. Subp. 53. Registered designated caregiver. "Registered designated caregiver" has the meaning given in Minnesota section 152.22, subdivision 11." Subp. 54: Registry program: "Registry program" has -the -meaning -given -in Minnesota - section 152.22, subdivision 12." "Subp. 55. Registry verification. "Registry verification" has the meaning given in Minnesota -section 152.22, subdivision 13." Subp. 56. Restricted access area. "Restricted access area" means a building, room, or other contiguous area upon the registered premises where cannabis is grown, cultivated, harvested-, stored, packaged; sold,- or processed for sale, under control of the medical cannabis manufacturer. Subp. 57. Service area. "Service area" means one of two regions of the state, based on geographic need for. -patient -access, -in which a medical cannabis manufacturer is located and Rev. 07/31/2014 Page 9 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabls.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 includes either- all even -numbered congressional -districts- or all-od&numbered congressional districts. Subp. 58. Sufficient cause to believe. "Sufficient cause to believe" means grounds put forth in good faith which are not arbitrary, irrational, unreasonable, or irrelevant and which make the proposition asserted more likely than not, provided the grounds are based on at least one of the following sources: A. facts -or- statements -supplied by a -patient, parent or legal -guardian, designated. registered caregiver, or an employee or agent of a medical cannabis manufacturer,• B. reports from an approved laboratory that indicate concerns with the chemical or bacterial composition of the medical cannabis,• C. financial records of a medical cannabis manufacturer; D. police records; E. court documents; or F. facts -of which the commissioner or the -commissioner's-employees have -personal - knowledge. 4770.0300 DUTIES OF THE COMNIISSIONER. Subpart 1. Interagency agreements. The commissioner shall enter in into any interagency agreements with other state agencies for technical services or other assistance related to the regulatory or inspection duties of a medical cannabis manufacturer and the registry program . Subp. 2. Notice to public safety. If the commissioner has sufficient cause to believe that there is a threat to public safety or to a patient then the commissioner shall notify the department of public safety and local law enforcement agencies of any conditions that pose a threat to public safety, including_ A. Loss or potential theft of medical cannabis or plant material; B. Diversion or potential diversion of medical cannabis or plant material; Rev. 0713112014 Page 10 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 C. Patient re ig_stry identification -scam -or theft. D. Others - ? Subp 3 Inspection of medical cannabis manufacturer. A medical cannabis manufacturer is subject to reasonable inspection by the commissioner under Minnesota Statutes, section 152 29 subdivision 1 For purposes of this partreasonable inspection means unannounced inspections by the commissioner of: A. all aspects of the business operations, B. all physical locations of medical cannabis manufacturer, its manufacturing facility, and distribution facilities; and C. all financial information and inventory documentation; and D. all physical and electronic security systems. Su -bp, 4 Fees, Any fees -collected. by- the commissioner- under -Minnesota -Statutes; section 152.35 are not refundable. Subp. 5. Patient costs; pricing. A. A medical cannabis manufacturer must follow the requirements under Minnesota Statutes section 152 35 paragraph (d) in establishing a reasonable fee. R. The commissioner shall -annually review price costing by a medical- cannabis manufacturer. 4770 0400 MEDICAL CANNABIS MANUFACTURER; OPERATIONS. Subpart 1 Operating documents. Under Minnesota Statutes, section 152.29, subdivision 1 the operatic documents of a medical cannabis manufacturer must describe all operational and management practices and must address the following: A. Record lceepingl Rev. 07/31/2014 Page 11 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reRs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 E: Security measures to -deter and -prevent theft of medical cannabis; C. Unauthorized entrance into areas containing medical cannabis; D. Types and quantities of medical cannabis products that are produced at the manufacturingfa` cility; E. Methods of planting (seed or clones), harvesting, drying and storage of medical cannabis; F. Estimated Quantity of waste material to be generated and disposal plans; G. Quantity and -method -for disposal -method -for affcrop -inputs -used-for cannabis plant production; H. Employee training methods for the specific phases of production,• 1. Biosecurity measures used in cannabis plant production and in medical cannabis production, J. Response strategies to reconcile discrepancies in accounting of product inventories; K. Sampling strategy and -quality testing for labeling pmoses• L. Medical cannabis packaging and labeling procedures; M. Procedures for the mandatory and voluntary recall of medical cannabis-, and N. Response plans for measures to be taken in the event of a security breach at a manufacturing or distribution facility, or while medical cannabis is in route to a manufacturing or distribution facility. SO% 2. Prohibited-actiyitim . Rev. 07/31/2014 A. No person shall own and operate a manufacturingfacility unless the person is registered as a medical cannabis manufacturer by the commissioner under Minnesota Statutes- section. 152.25.- B. A medical cannabis manufacturer and its employees,agents owners or principals must not: All Content Subject to Change Page 12 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 1. produce or manufaeture cannabis in any f locationT except in those areas designated in the registration agreement. 2. sell deliver, transport or distribute medical cannabis or medical cannabis from any location except its manufacturingfacility or its distribution facility; 3. produce or manufacture medical cannabis or for use outside of Minnesota; 4. sell or distribute medical cannabis to any person other than a: ipatient; (ii) parent or legal guardian; or (iii) designated registered caregiver . 5. deliver or transport medical cannabis to any location except its distribution facilities and a laboratory approved by the commissioner. 6. sell cannabis that is not packaged and labeled in accordance with f ...l; _ and 7. permit the consumption in or on the grounds of the medical cannabis manufacturer, its manufacturing facility and its distribution facility. Subp 3 Criminal background checks. A medical cannabis manufacturer is prohibited from employing any person who has a disqualifyingfelony elony offense following a Minnesota criminal history background check and a federal criminal -history background- check performed by the Bureau of Criminal Apprehension under Minnesota Statutes, section 152.29, subdivision 1. Subp 4- Conflict of -interest; Health care practitioner activity restrictions. A medical cannabis manufacturer shall not: Rev. 07/31/2014 A. permit a health care practitioner to hold a direct or indirect economic interest in the -medical- cannabis manufacturer; AN Coaten"', Subject to Change Page 13 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 B. allow a health care practitioner to serve on the board of directors or as an employee of the medical cannabis manufacturer; C. accept ,solicit, or offer any form of remuneration from or to a healthcare practitioner; or D. allow a health care practitioner to advertise with the medical cannabis manufacturer in any capacity. 4770.0500 MEDICAL_ CANNABIS MANUFACTURER; SAMPING; STABILITY TESTING. Subpart 1. Sampling protocols. A medical cannabis manufacturer shall: Rev. 0713112014 A. conduct sample collection in a manner that provides analytically sound and representative samples so that the medical cannabis that is dispensed is safe effective, and accurately labeled. B. document every sampling event and provide this documentation to the commissioner upon request. C. describe all sampling and testing plans in written procedures that include the method of sampling and the number of units per batch to be tested A medical cannabis manufacturer shall follow these written procedure; and D. ensure that random samples from each batch are: (i) taken in an amount necessary to conduct the applicable test; (ii) are labeled with the batch's unique identifier; and (iii) submitted for testing. All Content Subject to Change Page 14 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: heakh.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 Subp.2. Sampling, quality control. A. The quality control unit of a medical cannabis manufacturer must conduct sampling and testing with acceptance criteria that is sufficient to assure that batches of medical cannabis meet appropriate acceptance levels and appropriate rejection levels. B. A medical cannabis manufacturer shall reject medical cannabis failing to meet established standards or specifications and any other relevant quality control criteria. C. A medical cannabis manufacturer must develop and follow a policy and procedure for responding to results indicating contamination. The policy and procedure must include destruction of contaminated product and assessment of the source of contamination. D. A medical cannabis manufacturer must retain documentation of test results, assessment and destruction of product. E. Under certain circumstances the commissioner mayrequire reprocessing of samples Before acceptance and use reprocessed material must meet appropriate standards specifications and any other relevant criteria. Subt). 3. Stability Testing. A. A medical cannabis manufacturer must follow a written testing program designed to assess the stability characteristics of medical cannabis. The results of the stability testing must be used in determining appropriate storage conditions and expiration dates. The written program must include: Rev. 07/31/2014 Page 15 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reKs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 a. Sample size and test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability; b. Storage conditions for samples retained for testing; c. Reliable, meaningful, and specific test methods; d. Testing of the drug product in the same container -closure system as that in which the drug product is marketed; and e. Testing of medical cannabis for reconstitution at the time of dispensing (as directed in the labeling) as well as after they are reconstituted. (An adequate number of batches of each medical cannabis sample must be tested to determine an appropriate expiration date and a record of such data shall be maintained. 2) Accelerated studies, combined with basic stability information on the components drug products, and container -closure system may be used to support tentative expiration dates provided full shelf life studies are not available and are being conducted. 3) Where data from accelerated studies are used to project a tentative expiration date that is beyond a date supported by actual shelf life studies there must be stability studies conducted, including drug product testing at appropriate intervals until the tentative expiration date is verified or the appropriate expiration date determined Subp. 4. Reserve samples. 1) An appropriately identified reserve sample that is representative of each lot or batch of drug product shall be retained and stored under conditions consistent with product labeling. The reserve sample shall be stored in the same immediate container -closure system in which the drug product is marketed or in one that has essentially the same characteristics. The reserve sample shall consist of at least twice the quantity necessary to perform all the required tests. Rev. 07/31/2014 Page 16 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 2) The reserve sample must be retained for one year following the expiration date of the batch. 4770.0600 PERMITTING AND LOCATION. [Must comply Minn Stat 152.29 (i)1 [PLACEHOLDER Measuring Distances.1 For purposes of this chapter, the distance between one or more places must be: 1. Linear; and 2. the shortest distance between the closest point of the property lines of the places. 4770.0700 HOURS OF OPERATION; ACCESS. A. A medical cannabis manufacturer shall restrict access to a manufacturing facility where the production cultivation harvesting manufacturing packaging occurs. B. The commissioner shall limit the hours of operation of a manufacturing facility if there is sufficient cause to believe that limiting the hours of operation protects public safety. 4770.0800 ADVERTISING AND MARKETING. [Describe permissive and prohibited activities.] 4770 0900 MONITORING AND SURVEILLANCE REOUIREMENTS. Subpart 1 Closed-circuit surveillance system. A manufacturing facility must operate and maintain on the premises a closed-circuit television surveillance system on a twenty-four hour, seven day per week basis that visually records and monitors: A. all building entrances and exits; Rev. 07/31/2014 Page 17 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 B. other areas TBD [... j Subp. 2. Fixed cameras. Fixed cameras must be installed to provide a consistent recorded image of [...1. Subp 3. Camera specifications. Rev. 07/31/2014 A. A medical cannabis manufacturer must install a day/night camera in outdoor areas and in interior areas with low -light For purposes of this parta day/night camera means j ... L B. A medical cannabis manufacturer must ensure that all cameras are in good working order and must install additional lighting to ensure picture clari1y and bri htness. C. The recording device must be a digital video recorder that: 1. displays a date and time stamp on all recorded video,• 2. has the capability to produce a video disc directly from the DVR unit using an installed media recording drive. 3. Has a video on the disc that is viewable and compatible on any Windows PC, and include M required player software on the disc. 4. remain operational during a power outage. 5. Allow for the exporting of still images in current industry standard image format, including jpg, .bml2, and .gif. Exported video must have the ability to be archived in a proprietary format that ensures authentication of All Content Subject to Change Page 18 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 the video and guarantees that no alteration of the recorded image has taken place Exported video must also have the ability to be saved in a current industry_ standard file format that can be played on a standard computer operating system All recordings must be erased or destroyed before disposal. D. A display monitor with a minimum screen size of [... I and must be connected to the electronic recordingsecurity ecurity system at all times; E. Electronic recording security systems are required to be maintained in good working order at all times The owner of a manufacturing facility shall instruct each manager, employee or agent overseeing the functioning of the video recording security system to immediately report to the agent -in -charge any malfunctioning or technical problems with the system.- F. ystem. F. Security recordings must meet the following minimum requirements: 1. The recorded image resolution must be f ...1; and 2. The recorded image frame rate must be at least three (3) frames per second during alarm or motion based recording. G. Security recordings must be retained by the manufacturing facility for ninety (90) days and an additional ninety (90) days if the storage is off site. The recording system for the security cameras must be located in a locked, tamper- proof compartment. H. A medical cannabis manufacturer must. have available a video printer capable of immediately producing a clear still photo from any video camera image. I. Upon request the recordingor r any photo shall be turned over to the commissioner or to law enforcement. Rev. 07/31/2014 Page 19 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 J. Access to surveillance areas shall be limited to persons that are essential to surveillance operations, law enforcement agencies security system service personnel, the Department and others when approved by the Department A current list of authorized employees and service personnel that have access to the surveillance room must be available to the Department upon request Surveillance rooms shall remain locked. K. The electronic security system must be accessible to the commissioner and law enforcement agencies l...1. 4770.1000. ALARM SYSTEM REQUIREMENTS. A. A medical cannabis manufacturer must install maintain and use a professionally monitored robbery and burglary alarm system that provides coverage of all facility entrances and exits, rooms with exterior windows rooms with exterior walls roof hatches, skylights, and storage rooms and is equipped with: 1. Duress Alarm. A duress alarm means a silent security alarms stem signal generated by the entry of a designated code into an Arming Station to signal that the Alarm User is being; forced to turn off the system; 2. Panic Alarm, which means an audible Security Alarm Svstem signal generated by the manual activation of a device intended to signal a life threatening or emergency situation requiring law enforcement response,• 3. Holdup Alarm, which means a silent alarm signal generated by the manual activation of a device intended to signal a robbery in progress; 4. Automatic Voice Dialer, which means any electrical electronic mechanical or other device capable of being programmed to send a prerecorded voice message Rev. 07/31/2014 Page 20 of 40 All Content Subjeca to Chznge The Minnesota Department of Health encourages feedback on these draft rules at: health. cannabis.reg@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 when activated over a telephone line radio or other communication system, to a law enforcement public safety or emergency services agency requesting dispatch; 5. failure notification system that provides an audible, text or visual notification of any failure in the surveillance system. The failure notification system shall provide an alert to the manufacturing facility within 5 minutes of the failure, either by telephone, email, or text message; 6. the ability to remain operational during a power outage and ensure all access doors are not solely controlled by an electronic access panel to ensure that locks are not released during power outage. B. A medical cannabis manufacturer shall provide access to its security alarm system upon request of the commissioner or local law enforcement agencies. 1...1 C. The system must be inspected and all devices tested annually by a qualified alarm vendor. 4770.1100. TRANSPORTATION OF MEDICAL CANNABIS. A. Before transporting medical cannabis a medical cannabis manufacturer must: 1. Complete a shipping manifest on a form prescribed by the commissioner; 2. Securely transmit a copy of the shipping manifest to the commissioner before the close of business the day before transport. The manifest must be made available to law enforcement upon request. 3. Maintain all shipping manifests and make them available upon request of the commissioner. Rev. 07/31/2014 Page 21 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 B. A medical cannabis manufacturer transporting medical cannabis must transport the medical cannabis in a locked, safe, and secure storage compartment that is part of the motor vehicle transporting the medical cannabis, or, or in a locked storage container that has a separate key or combination pad which is not visible from outside the motor vehicle. C. Any motor vehicle transporting cannabis must travel directly from the manufacturing facility to the dispensary facilfty or to a testing laboratory, is prohibited from malting M stops in between except to other distribution facilities or laboratories, for refueling. In the event of an emergency stop, a medical cannabis manufacturer employee shall report the emergency stop to: 1. law enforcement through the 911 emergency system, 2. the medical cannabis manufacturer who shall then immediately, nnotify the commissioner; and 3. prepare an incident report on a form prescribed by the commissioner. D. A medical cannabis manufacturer must ensure that all delivery times and routes are random. E. A medical cannabis manufacturer must staff all transport motor vehicles with a minimum of two employees. At least one employee must remain with the motor vehicle at all times that the motor vehicle contains medical cannabis. F. Each employee must have access to a secure form of communication with personnel at the cultivation facility, the distribution facility, and the ability to contact law enforcement through the 911 emergency system at all times that the motor vehicle contains cannabis. Rev. 07131/2014 Page 22 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health. cannabis.rees@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 G. An employee must carry his or her employee identification card at all times when transporting or delivering-` cannabis and, upon request, shall produce the identification card to the commissioner or to a law enforcement officer acting in the course of official duties. 4770.1200. DISPOSAL OF MEDICAL CANNABIS AND PLANT MATERIAL. A. Cannabis waste must be stored secured locked, and managed in accordance with [ ..l and the operating documents of the medical cannabis manufacturer. B. Liquid waste from a manufacturingfacility must be disposed of in compliance with [... I and associated administrative rules. C. Disposal of hazardous waste and chemical waste must be conducted in accordance with federal, state and local laws. D. Cannabis waste must be rendered unusable in accordance with [...1 before leaving a manufacturing facility. E. A manufacturing facility shall maintain a traceability system that documents the rendering and disposal of notify the commissioner and the commissioner of public safety seven days [... l in the traceability system described in this Part before rendering the product unusable and disposing of it. F. Disposal methods: 1. Rendering unusable 2. Incinerating 3. Composting Rev. 07/31/2014 Page 23 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.ress@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 4770.1300. MANDATORY SIGNAGE. A. A medical cannabis manufacturer shall post a sign in a conspicuous location at each entrance of the manufacturingfacility that reads, "PERSONS UNDER TWENTY- ONE YEARS OF AGE NOT PERMITTED ON THESE PREMISES." B. A medical cannabis manufacturer shallpost a sign in a conspicuous location at each entrance of the premises that reads, "THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE." C. An employee of a medical cannabis manufacturer shall keep his or her employee identification card visible at all times when on the property of a cultivation center and during the transportation of medical cannabis to a registered dispensary organization D. A visitor shall keep a visitor pass issued by the medical cannabis manufacturer visible at all times. 4770.1400 PERSONNEL IDENTIFICATION SYSTEM. A medical cannabis manufacturer must have a personnel identification system that consists of - employee identification cards and L,,. . Subpart 1. Employee identification card requirement An employee identification card must contain: A. The name of the cardholder: B. The date of issuance and expiration; C. An alphanumeric identification number that is unique to the holder; and D. A current photograph of the cardholder. Rev. 0713112014 Page 24 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reasLWstate.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 Subp. 2 Employee identification card on person and visible at all times. A medical cannabis manufacturer employee must keep his or her identification card visible at all times when on the premises of the medical cannabis manufacturer and during the transportation of medical cannabis to a distribution facility. Subp. 3. Termination of employment. Upon termination of an employee, a medical cannabis manufacturer must immediately seize and the terminated employee's identification card. Subp. 4. Lost or stolen employee identification cards. A medical cannabis manufacturer shall immediately eport the loss theft or destruction of an employee identification card to the commissioner and to local law enforcement agency 4770.1500. CLOSURE OF OPERATIONS; DEREGISTRATION. Subpart 1 Notice A medical cannabis manufacturer shall notify the commissioner at least six months before the closure of the manufacturingfacility acility and its distribution facilities. If the commissioner determines that a medical cannabis manufacturer is in violation of Minnesota Statutes section 152 25 paragraph (b) or (c) then the commissioner shall not renew the manufacturer's registration. Include due process provisions. [PLACEHOLDER: Procedures for facility shutdown] 4770.1600. RECORD KEEPING; REQUIREMENTS. A. A medical cannabis manufacturer shall maintain for seven years true, complete, legible and current books and records including the following: 1. The date of each sale or distribution to a distribution facility; 2. The name address and registration number of the distribution facility; Rev. 0713112014 Ali Content Sublecat to Change Page 25 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: heaKh.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 3. The item number, product name (description), and quantity of cannabis and cannabis -infused products registered by the Department and sold or otherwise distributed to the dispensary 4. The price charged and the amount received for the medical cannabis from the medical cannabis manufacturer; 5. If the distribution was for a purpose other than sale, the reason for the distribution, 6. The quantity and form of medical cannabis maintained by the medical cannabis manufacturer at the manufacturingfacility acility on a daily basis, and 7. The amount of plants being grown at the manufacturingfacility on a dailybasis. B. A medical cannabis manufacturer shall maintain records that reflect all financial transactions and the fmancial condition of the business. The following records must be maintained for seven years and, upon request of the commissioner, must be available for inspection: Rev. 07/31/2014 1. Purchase invoices, bills of lading, manifests, sales records, copies of bills of sale and M supporting documents, to include the items and/or services purchased, from whom the items were purchased, and the date of purchase; 2. Bank statements and canceled checks for all business accounts; 3. Accounting and tax records; 4. Records of all financial transactions, including contracts and agreements for services performed or services received; 5. All employee records, includingtraining, aining, education, and discipline. All Content Subject to Change Page 26 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: heakh.cannabi§.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 Rev. 07/31/2014 6. Soil amendment fertilizers pesticides as required by_[ ... ],crop production aids applied to the growing medium plants or used in the process of growing cannabis; 7. Production records including planting, harvest and curing, weighing, destruction of cannabis creating batches of cannabis -infused products and packaging and labeling,• disposal of cannabis cannabis -infused products and waste materials associated with production. 8. Records of each batch of extracts or cannabis -infused products made, including at a minimum usable cannabis or trim leaves, and other plant matter used (including the total weight of the base product used), any solvents or other compounds utilized and the product type and the total weight of the end product produced such as hash oil shatter, tincture, infused dairy butter, etc. 9. Transportation records; 10. Inventory records; 11. Records of all samples sent to an independent testing lab and/or the Department's lab and the quality assurance test results; 12. All samples provided to any person for any purpose; and 13. Records of any theft loss or other unaccountability of any cannabis, medical cannabis, or plant material. All Content Subject to Change Page 27 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reRs@state.Mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 4770.1700 MEDICAL CANNABIS MANUFACTURER; PRODUCTION REQUIREMENTS. [PLACEHOLDER: Reliable and ongoing supply. "Reliable and ongoing supply" means a three-month supply of cannabis plant material and other materials as determined by the commissioner.] 4770.1800 MEDICAL CANNABIS MANUFACTURER; DISTRIBUTION PROTOCOLS: DISTRIBUTION FACILITY. 1) Securi a. Track/trace-able entry b. Camera's in lobby and inside distribution area c. Panic button d. Signage about security e. Backup battery or system in case power cut or out 2) Transportation a. Staff requirements (i.e. criminal background) b. Secure transport (i.e. lockable or secure totes) c. Schedules 3) Inventory Control a. Orderinjz b. Receiving/delivery conditions (i.e. must be during business hours) c. Audits d. Discrepancies — how to handle e. Waste — MPCA f. Storage conditions — temp/humidity controls — no offsite storage — security requirements (i.e. vault?) Rev. 07/31/2014 Page 28 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 g. Daily distribution logs/printouts 4) Distribution a. Software b. Patient ID confirmation c. Patient registry lookup d. Patient profile i. Demo rag �hics ii. Prescriptions iii. Health conditions iv. Allergies v. Comment field e. Labeling requirements f Sales — track able pickup g. Returns h. Accountability i. Who entered order ii. Who filled order iii. Who certified as correct iv. Unique identifiers (biometric initials, auto log offs) 5) Support Staff a. Pharmacist b. Technician c. Duties/expectations d. Qualifications/criminal background checks e. Policies and procedures f. Training 6) Expectations/Unprofessional conduct a. HIPPA Rev. 07/31/2014 Page 29 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.regs@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 b. OSHA c. Diversion d. Compromising security e. Accessories to illegal drug traffic f. Violation of any law, rule, regulation, or ordinance g. Involved in kickbacks, rebates, special charges h. Discrimination i. Maintain sanitary, orderly and clean distribution center 7) Software a. POS - b. Distribution c. Requirements d. Accountability e. Updates f. Upgrades g. SecuKity h. Backups i. Internet access (for PMP access, registry, drug information) j. Inter connectivity k. Report functions/forms 1. Inventory control m. Flexibilitv 4770.1900 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM. Subpart 1. Scope. The medical cannabis laboratory uproval program under Minnesota Statutes, section 152.22 approves a laboratorypendent of a medicinal cannabis manufacturer. Rev. 07/31/2014 All Content Subject to Change Page 30 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reasCo)state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 Subp. 2 Available products types and analytes. A The commissioner shall approve a laboratory that test samples for any species of the genus cannabis plant or any other mixture or preparation of them, including whole plant extracts and resins delivered in the following �product types according to Minnesota Statutes section 152.22, subdivision 6: (1) liquid including, but not limited to, oil; 2pill; (3) vaporized delivery method with use of liquid or oil but which does not require the use of dried leaves or plant form; or (4) any other method excluding smoking approved by the commissioner. A. The commissioner shall maintain and publish a list of all analytes available for approval The category of analytes include: 1. Cannabinoid profile, 2. Metals; 3. Pesticide residues and plant growth regulators-, ators-, 4. Microbiological contaminants and mycotoxins; and 5. Residual solvents; B. The list of analytes must be reviewed at least every six months and any updates published in the State Register and posted on the program's website. The commissioner shall publish the notification of changes and review comments on the changes no less than 30 days from the date the list is published. Rev. 07/31/2014 Page 31 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.ress@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 4770.2000 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; APPLICATION. Subpart 1. Application Requirements. A. A laboratory ma y request to be approved by the commissioner for the use of procedures to test the product types and analytes eligible for approval according to XXXX or subpart XXXX (reference to "Available product types and analytes"). B. A laboratory is encouraged to operate formal management systems in accordance to International Organization for Standardization (ISO). The ISO/IEC 17025 General Requirements for the Competency of Testing and Calibration Laboratories includes technical and management system requirements. C. A laboratory seeking initial or renewal medical cannabis laboratory approval after December 31, 2016, must be accredited to Standard ISO/IEC 17025:2005 General Requirements for the Competency of Testing and Calibration Laboratories of the International Organization for Standardization. D. A laboratory must specify the field of testing for which it seeks approval. No laboratory approval shall be awarded for any field of testing without the laboratory_ meeting the approval requirements. No laboratory may receive approval without approval of at least one field of testing. E. A laboratory must apply on a form provided by the commissioner. The laboratory must supply the following information: 1. the legal name and legal status of the laboratory, 2. the physical location, postal mailing address of the laboratory 3. the owner of the laboratory; Rev. 0713112014 All Content Subject to Change Page 32 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 4. the names and telephone numbers and electronic mail address of a designated contact person; 5. the names and telephone number and electronic mailing address of laboratory director; 6. the name of at least one managing agent; and 7. the name of at least one technical manager. F. A laboratory must submit with the completed application form the following items: (1) a signed and notarized attestation form stating the laboratory is independent from the medical cannabis manufacturers. The laboratory must declare any conflict of interest actual or perceived relating to the direct or indirect financial interests in medical cannabis manufacturer; (2) a quality assurance manual, (3) standard operating procedures ; (4) sample handling receipt and acceptance procedures and policies; (5) demonstration of laboratory capability and acceptable performance through a combination of: L existing certificates/approvals; ii. documented demonstrations of anal ical capabilities; iii. documented and acceptable proficient testing esting samples from an approved provider, where available (6) method validation procedures for testing methods, (7) the name and educational qualifications of at least one technical manager responsible for the laboratory achieving and maintainingthe he quality and analytical standards of practice; (8) a copy of the lab's ISO/IEC 17025:2005 Certificate and Scope of Accreditation, on or before December 31, 2016. Rev. 07/31/2014 Page 33 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 (9) a copy of the lab's most recent assessment report including the scope of the assessment to ensure the evaluation of the medical cannabis fields of testing, on or before December 31, 2016. Subp, 2. Additional Application Requirements for Mobile Laboratories. A. A mobile lab is considered a separate laboratory and is subject to all requirements, including application requirements, of parts XXXX to XXXX. B. In addition to the requirements under subpart XX, a mobile laboratory must submit a vehicle identification number, license plate number, or other uniquely identifmg information. C. A mobile laboratory must designate which fields of testing, equipment and personnel are associated with the mobile laboratory_ Subp. 3. Application Review. Within 30 days of receiving the application form and the information required in subpart XX, the commissioner shall: A. notify the laboratory in writingof any omission or error in the application; B. deny approval for an initial application or revoke approval for a renewal application if the laboratory does not submit to the commissioner the required information within 15 days after receiving an error notice under item A; C. award approval according to subpart XX if the laboratory's application meets the applicable standards of parts XXXX to XXXX D. notify the laboratory that its current approval for fields of testing shall be continued until the commissioner fully reviews all documentation for compliance Subp. 4. Laboratory Inspection and Reports. A. The commissioner may conduct inspections of a laboratory requesting approval or approved laboratories. A laboratory meeting the application requirements may Rev. 07/31/2014 Page 34 of 40 AR Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 perform analyses and report results with the same approved status, the interim gpproval status shall not exceed 6 months. B. The commissioner may notify a laboratory before arrival at the facility or may conduct an inspection without prior notice at any time during normal business hours to verify compliance with parts XXXX to XXXX. When the commissioner provides notification the notification may be written or oral. C. The commissioner mayrequire third party validation and on-going monitoring of the laboratory to ensure proficiency, execution and validation of analytical methodologies The laboratory must pay for all costs associated with the commissioner ordered third party validation. D. The commissioner may consult and request reports from the approved laboratory regarding chemical compositions dosages and noncannabis drug interactions under Minnesota Statutes. section 152.24. E. The commissioner maintains the right to request reports and procedures from an applicant or approved laboratory in regards to compliance with this rule. 4770 2100 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; COMMISSIONER APPROVAL OR DENIAL. Subpart 1. Awarding Approval A. The commissioner's documentation of laboratory approval must include: (1) a letter acknowledging compliance with approval requirements by the laboratory, (2) the scope of approval for the laboratory; (3) the logo of the Minnesota Department of Health, (4) the name of the laboratory; (5) the address of the laboratory; and (6) the expiration date of the approval. Rev. 07/31/2014 Page 35 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 B. If a laboratory's scope of approval changes, the commissioner shall issue a new document with the scope of approval; C. A laborato 's approval is valid for one year from the date of awarding approval or renewal of approval, unless conditions warrant denial or rescinding approval by the commissioner under subparts X and X. D. A laboratory must return its approval letter to the commissioner upon rescinding approval of the laboratory. E. An approved laboratory must not misrepresent its approval on any document including laboratory reports, catalogs, advertising, business solicitations, proposals, quotations, or other materials. F. A laboratory must make available its current approval documentation and corresponding scope of approval upon the request of a client, approval authority, or regulatory agency. The laboratory must not supply a copy of its current approval without the accompanying copy of its scope of approval. Subt). 2. Denial of laboratory approval. The denial or approval for the approved medical cannabis laboratory list is considered a final decision of the commissioner and is subject to judicial review under the Administrative Procedure Act under Minnesota Statutes, chapter 14. 4770.2200 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; LIST OF APPROVED LABS. Subpart 1. Commissioner list of approved cannabis labs (a) the commissioner shall publish a list of approved cannabis laboratories, the primary laboratory contact phone numbers location and lab's scope of approval. Subp. 2. Approval rescinded. The commissioner shall rescind approval for an approved cannabis laboratory if the commissioner determines one or more of the following reasons exist: Rev. 07/3112014 Page 36 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.ress@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 (1) Failure to comply with or misrepresentation of application materials per (2) Nonconformance with the applicable laws, rules, standards, policies and procedures; (3) History of repeated nonconformance or complaints regarding the analysis of medical cannabis; (4) Failure to allow the commission or designee to perform physical inspection of facilities or failure to provide copies of inspection and corrective report(s) issued b thepproved ISO/IEC 17025 accreditation body,and (5) Failure to provide the medical cannabis manufacturer (s) with timely reports compliant with the commissioner's designated test report format Subv. 3 Decision of the commissioner is final. Rescinding approval from the approved medical cannabis laboratory list is considered a final decision of the commissioner and is subject to judicial review under the Administrative Procedure Act under Minnesota Statutes, chapter 14. 4770 2300 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; VARIANCES. The commissioner may grant a variance from parts XXXX to XXXX. To request a variance, a laboratory must indicate in writing: (1) The rule part and language for which the variance is sought; (2) Reasons for the request, (3) Alternate measures that will be taken if the request for variance is granted; (4) The length of time of the variance; and (5) Data to ensure analytical results of equal or better reliability, if applicable. Rev. 07131/2014 Page 37 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 4770.2400 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; VOLUNTARY WITHDRAWAL OF APPROVAL. A. If a laboratory chooses to withdraw its application for approval or its current approval in total or in part, then the laboratory must notify the commissioner in writing and specify the effective date of withdrawal. B. By the effective date of the withdrawal of approval, in total or in pant the laboratory must notify current clients, manufacturers and regulatory agencies of its intent to withdraw its approval and must indicate the effective date of the withdrawal. The notifications from the laboratory must be in writing. The laboratory must submit a copy of each notification to the commissioner at the that the notification is sent to clients manufacturers or re u�ry agencies. 4770.2500 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; DUTY TO NOTIFY. A. A laboratory must notify the commissioner in writing within 30 days of a change in: Rev. 07/3112014 (1) the name of the laboratory; (2) the physical location, postal mailing address, and electronic mailing address of the laboratory; (3) the owner of the laboratory, (4) the names, telephone numbers or email address of the designated contact person; (5) the name of at least one managing agent with signatures attested by notarial officers; (6) the names of at least one technical manager; (7) major analytical equipment; or (8) test methods Ali Content Subject to Change Page 38 of 40 The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 B. With the notification a laboratory_ must provide results of proficiency testing samples or demonstrations or capabilfty, analyzed in the new laboratory location or analyzed under the change in laboratory owner, instrumentation or methods. 4770 2600 MEDICAL CANNABIS LABORATORY APPROVAL PROGRAM; APPEAL OF ADMINISTRATIVE DECISION. A The commissioner shall notify a laboratory in writing the reason(s) for the decision to deny or rescind laboratory approval. B A laboratory has 30 days from the date of received the decision to appeal the decision. A request to appeal the decision must: (1) be in writing; (2) indicate the facts the laboratory disputes; (3) be signed by the laboratory managing agent-, and (4) be sent to the commissioner. C. Upon receipt of an appeal request the commissioner shall initiate the procedure for a contested case hearing according to Minnesota Statutes, chapter 14, and rules of the Office of Administrative Hearings. 4770 2700 MEDICAL CANNABIS MANUFACTURER; FINANCIAL EXAMINATIONS; PRICING REVIEWS. A. A medical cannabis manufacturer must maintain fmancial records in accordance with generally accepted accounting principles (GAAP) and upon request must provide any financial records to the commissioner. B. The commissioner shall request an additional audit of the medical cannabis manufacturer, of the same time period if the commissioner finds one or more of the following: Rev. 07/3112014 Page 39 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us CHAPTER 4770, MEDICAL CANNABIS REGISTRY PROGRAM; MANUFACTURER REQUIREMENTS Laws 2014, Ch 311 1. credible evidence or allegations of financial reporting irregularities not revealed in the annual certified financial audit: or 2. operational or compliance concerns involving financing budgeting revenues sales or pricing. Rev. 07/31/2014 Page 40 of 40 All Content Subject to Change The Minnesota Department of Health encourages feedback on these draft rules at: health.cannabis.reas@state.mn.us Minnesota Department of Health Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Expected Publication Date: September 5, 2014 Request for Application Response Deadline: October 3,_ 2,O.L4 Document Rev. 0810112014 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.uus Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Table of Contents Overview............................................................................................................................................ 3 Numberof Manufacturers.................................................................................................................. 3 RFA Intent to Apply & Submission Deadline.................................................................................... 4 Termsand Conditions......................................................................................................................... 6 Communications with the Department............................................................................................... 6 DataPractices..................................................................................................................................... 7 ApplicationContent............................................................................................................................ 9 Evaluation_ and Selection Pr_o.cedures....-..___.------------------- ...................-...24. Rev. 08/01/2014 Page 2 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.rnn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Minnesota Department of Health Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers The Minnesota Department of Health ("MDH" or "Department") is requesting applications from parties interested in receiving a Medical Cannabis Manufacturer Registration. Overview On May 31, 2014 the Department became responsible for administering Minnesota's Medical Cannabis program with the enactment of Chapter 311 of the 2014 Minnesota Session Laws. This program allows a qualifying patient or caregiver who is registered with MDH to purchase medical cannabis from a manufacturer's distribution site for the palliative treatment of a patient's debilitating medical condition. In accordance with Chapter 311, the Department is issuing this Request for Application ("RFA") for purposes of registering up to two Medical Cannabis Manufacturers. Number of Manufacturers MDH anticipates awarding two Manufacturer Registrations, one serving the portion .of the state encompassed by the I, 3-, 5 and 7th Congressional Districts and the other serving the 2, 4, 6 and 8th Congressional Districts. The Manufacturers will be registered on a competitive basis based on an evaluation of the timely submitted responses to this RFA. This RFA does not obligate the Department to register a Medical Cannabis manufacturer. The Department reserves the right to award fewer than two registrations if the Department concludes that an insufficient number of qualified applicants submitted a response prior to the deadline. In such an event, the Department may re -issue the RHA to solicit additional applications until at least two Manufacturer Registrations are awarded. Rev. 08/01/2014 All Content Subject to Change Page 3 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers RFA Intent to Apply & Submission Deadline RFA Intent to Apply In order to efficiently manage the evaluation process and for an application to be considered a Intent to Apply letter must be submitted via email to health.cannabis.RFA@state.mii.us with the subject line "Medical Cannabis RFA Intent to Apply — Manufacturer Name" by Friday, September 19, 2014 at 3 pm Central Daylight Time. The Intent to Apply letter should 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 evaluation 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 by September 19th then the RFA Response will NOT be accepted and considered. How to Apply It is recommended all potential applicants become familiar with Chapter 311 of the 2014 Minnesota Session Laws and the draft administrative rules governing manufacturer operations for the medical cannabis registry program (Revisor No. R-4272) that MDH intends to propose in early October and adopt by December 1, 2015 (http•//www.health.state.mn.us/topics/cannabis/draftrules.html). Applicants should use the definitions sections of those documents to assist in interpreting this RFA. Each applicant must prepare comprehensive document that responds to and provides relevant documents, for each item requested in this RFA. All attachments, exhibits or other information produced in response to the RFA must include a label referencing the item number and subpart of this_ RFA - to -which it responds so that it is clear to the Department that all requested information is provided. A complete application package must include: 1. An original and twenty paper copies of the RFA response, all of which must be single -sided and securely bound; and 2. A CD containing an electronic version of your complete submission in Rev. 0810112014 All Content Subject to Change Page 4 of29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Terms and Conditions Applicants may submit a modification to their RFA response, with an accompanying explanatory cover letter, at any time prior to the submission deadline. MDH may disqualify any applicant who: Fails to submit a complete response; or a Fails to pay the application fee prior to the submission deadline; or Submits incomplete, false, inaccurate, unresponsive or misleading information in response to this RFA. The decision of MDH to disqualify an applicant or not award a Manufacturer Registration is final. An applicant awarded a Manufacturer Registration shall operate in accordance with the representations made in its RFA submissions, or as modified upon mutual agreement with MDH. Communications with the Department All questions about the RFA or RFA process must be forwarded to MDH only by email at health.cannabis.RFA@state.mn.us with the subject line "Medical Cannabis RFA Question." Questions and answers of a substantive nature will be posted on the-MDH website http://www.healtb.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. For questions received after Tuesday, September 23, 2014, the Department may not be able to respond prior to the Submission Deadline. Applicants are therefore, encouraged to identify and raise any questions to the Department's attention as soon as possible. To ensure the proper and fair evaluation of all applications, other communications regarding this RFA including verbal, telephone, written or internet initiated by or on behalf of any applicant to any employee of the Department, other than questions submitted to health.cannabis.RFA@state.mn.us, are prohibited. Any violation of this prohibition may result in the disqualification of the applicant. Rev. 08/01/2014 All Content Subject to Change Page 6 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.rnn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Data Practices All materials submitted in response to this RFA will become property of 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 that is registered are public data, unless the data are trade secret or security information under Minnesota Statues section 13.37. If a registration is awarded to an applicant, MDH may use or disclose the trade secret data to the extent provided by law. Any decision by the State to disclose information determined to be trade secret information will be made consistent with the Minnesota Government Data Practices Act, Minnesota Statutes chapter 13, and other relevant laws and regulations If the Applicant submits information in response to this RFA that it believes to be trade secret information as defined by Minnesota Statutes section 13.37, and the Applicant does not want such data used or disclosed for any purpose other than the evaluation of this Proposal, the Applicant must: A. Clearly mark every page of trade secret materials in its Proposal at the time the Proposal is submitted with the words "TRADE SECRET INFORMATION" in capitalized, underlined and bolded type that is at least 20 pt.; the State does not assume liability for the use or disclosure of unmarked or unclearly marked trade secret information; B. Fill out and submit the attached "Trade Secret Information Notification Form specifying the pages of the Proposal which are to be restricted and justifying the trade secret designation for each item. If no material is being designated as trade secret information, a statement of "None" should be listed on the form; and C. Satisfies the statutory burden to justify any claim of trade secret information. MDH reserves the right to reject a claim that any particular information in a response is trade secret information if it determines Applicant has not met the burden of establishing that the information constitutes a trade secret. MDH will not consider prices or costs submitted by the Applicant to be trade secret information under any circumstance. Use of generic trade secret language encompassing substantial portions of the proposal or simple assertions of trade secret interest without substantive explanation of the basis therefore will not be sufficient to warrant a trade secret designation. If certain information is found to constitute trade secret exception and information, the remainder of the Proposal will become public; in the event a data request is received for Proposal information only the trade secret data will be removed Rev. 08/01/2014 Page 7 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers a searchable PDF file format. 3. A twenty thousand dollar ($20,000) non-refundable application fee in the form of a check, made out to: Minnesota Department of Health — OMC. The submittal of an application constitutes acceptance of the requirements, administrative stipulations and all of the terms and conditions of this RFA. All costs and expenses incurred in submitting an application in response to this RFA will be borne by the responder. Response Deadline & Submission For an application to be considered, a complete response to this RFA and the non-refundable application fee must be hand -delivered to MDH's offices (see address below) on or before 3:00 pm Central Daylight Time on Friday, October3,2014. Mail, fax, and email applications will not be considered. MDH will time -stamp each application upon its submission and the time -stamp shall serve as the official record of when the application was delivered to MDH. A MDH employee will be available in the between the hours of 10:00 am and 3:00 pm each business day in the two weeks leading up to the submission deadline. Applications will only be accepted during those hours. All RFA submissions to the Department must be given to a MDH employee and time -stamped at the time of delivery. Application submissions should not be left unattended in the office or on a desk. MDH RFA Delivery Address: Attn: Jeff Smith — Loading Dock Minnesota Department of Health Office of Medical Cannabis 625 Robert Street North St. Paul, MN 55155 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, MN. It is the applicant's responsibility to allow sufficient time to address potential delays. Sole responsibility rests with the applicant to ensure that their application is received and time -stamped on or before the submission deadline. Late applications will not be accepted. Rev. 08/01/2014 All Content Subject to Change Page 5 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers and remain nonpublic. The applicant must defend any action seeking release of the materials it believes to be trade secret information, and indemnify and hold harmless the State, its agents and employees, from any judgments awarded against the State in favor of the party requesting the materials, and any and all costs connected with that defense. This indemnification survives the State's award of a registration. In submitting a response to this RFA, the Applicant agrees that this indemnification survives as long as the trade secret information is in the possession of MDH. MDH is required to keep all the basic documents related to its contracts, for the manufacturers that are successfully registered this includes their RFA response documentation, for a minimum of six years after the end of the registration. Non - selected manufacturer's RFA Proposals will be kept by MDH for a minimum of one year after the award of a registration. Rev. 08/01/2014 Page 8 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.rnn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Application Content The Department expects each application to contain information for the following sections to allow a thorough understanding of the applicant's ability to meet the needs and expectations of patients, MDH and the residents of the State of Minnesota. In each of the sections below individual pieces of information will be requested. Each item must be responded to, if you do not have the information requested you must state that the information is not available rather than not address the item. Applications that do not contain a response for each requested item will be disqualified and not scored. A. Business Overview B. Facilities C. Product Development D. Operations E. Business Plan F. Ownership & Financial Structure G. Bonus Points H. Conclusion Applicants should understand the contents of Chapter 311—S.F.No.2470 and strive to provide complete explanations of how their firm has the experience, ability and financial resources to create and run a medical cannabis business pursuant to what is outline in the law. A. BUSINESS OVERVIEW 1. Brief Summary Provide a brief summary (no longer than five double-spaced pages) of the applicant's qualifications, experience and industry knowledge relevant to the development and operation of a medical cannabis production facility. 2. Application Checklist Please complete the following checklist which contains statutory requirements that must be met in order to be a registered manufacturer. Rev. 08/01/2014 All Content Subject to Change Page 9 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Minnesota Department of Health Office of Medical Cannabis Statutory Application Checklist Applicant Name: Application Date: Service Area: Statutory Requirement Yes 1 I certify I have read the provisions of Minn. Stat. §§152.22 — 152.37 ❑ and my application complies with all the statutory requirements 2 My proposal entails a plan that would accomplish supplying medical ❑ cannabis to patients by July 1, 2015 3 My proposal entails a plan that would begin distribution at four (4) ❑ distribution facilities supplying medical cannabis to patients by July 1, 2016 4 I certify I will contract with a laboratory, subject to the commissioner's ❑ approval of the laboratory and any additional requirements set by the commissioner, for purposes of testing medical cannabis manufactured by the medical cannabis manufacturer as to content, contamination, and consistency to verify the medical cannabis meets the requirements of Minn. Stat. §§152.22, subdividion 6 5 I certify I will document and make available on request the following operating documents: a. Procedures for the oversight of the manufacturer and ❑ procedures to ensure accurate recordkeeping b. Procedures for the implementation of appropriate security ❑ measure to deter and prevent the theft of medical cannabis and unauthorized entrance into areas containing medical cannabis Rev. 08/01/2014 All Content Subject to Change FE - 0 Page 10 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Statutory Requirement Yes No 6 My proposal would implement security requirements, including ❑ ❑ requirements for protection of each location by a fully operational security alarm system, facility access controls, perimeter intrusion detection systems and a personnel identification system 7 I certify oui manufacturing facility will not share office space with, ❑ ❑ refer patients to a health care practitioner, or have any financial relationship with a health care practitioner 8 I certify that we will not permit any person to consume medical ❑ ❑ cannabis on the property of the manufacturing or distribution facilities 9 I acknowledge I am subject to reasonable inspection by the ❑ ❑ commissioner and his or her designates 10 I certify I will not employ any person who is under 21 years of age or ❑ ❑ who has been convicted of a disqualifying felony offense and that all employees and staff must submit to a criminal history records check and a full set of classifiable fingerprints prior to beginning work 11 I certify I will not operate in any location, whether for distribution or ❑ ❑ cultivation, harvesting, manufacturing, packaging, or processing, within 1,000 feet of a public or private school existing before the date of the manufacturer's registration 12 I certify thatI will comply with reasonable restrictions set by the ❑ ❑ commissioner relating to signage, marketing, display, and advertising of medical cannabis The undersigned attests that the applicant organization will adhere to the statutory requirements listed above and that they have the authority to bind the applicant organization to the statutory requirements. Name — Signature Name - Printed Date Rev. 08/01/2014 Page 11 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis -Manufacturers B. FACILITIES 1. Intended Service Area Please identify whether the applicant is seeking to be registered for Service Area A (the portions of the state located in the 1, 3, 5 and 7th Congressional Districts) or Service Area B (the portions of the state located in the 2, 4, 6, and 8th Congressional Districts), bearing in mind that a desire exists that no two distribution facilities for either manufacturer be closer than 30 miles to one another (with the exception of Districts 4 & 5). Applicants may submit applications for more than one Service Area but each application must be limited to one Service Area and submitted separately in the format specified in this RFA. 2. Facility Development Please provide the following information: a. The location of the proposed production facility (it must be located in the State of Minnesota); b. Documents sufficient to establish that the applicant is authorized to conduct business in Minnesota; and that state and local building, fire and zoning requirements and all applicable local ordinances are met for the proposed location of the production facility. If documents to this effect do not exist yet, please indicate this but provide the information that does exist and the plan and timeline to finalize the documentation. All documentation must be provided to the Department by November 14, 2014 in order to be a registered manufacturer; c. If the property is not owned by the applicant, provide a written statement from the property owner certifying that they have consented to the applicant operating a production facility on the premises; d. Any signage, lettering, text and graphic materials that will be shown on the exterior of the proposed production facility; e. Photographs of the surrounding neighborhood and businesses within 500 feet of the manufacturer's property, sufficient to evaluate the proposed production facility's compatibility with commercial or residential structures already constructed, or under construction, within the surrounding area; f. A map that identifies all places used primarily for religious worship, public or private schools, convents, charitable institutions whether supported by private or public funds, hospital or veterans' Rev. 08/01/2014 All Content Subject to Change Page 12 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers homes, or any camp or military establishment that are within 1000 feet of the proposed production facility location; and g. A site plan, drawn to scale, of the proposed production facility showing all perimeter fencing as well as all streets, property lines, buildings, parking areas, and outdoor areas, if applicable, that are within a 500 foot radius of the production facility; h. A blueprint or floor plan, drawn to scale, of the proposed production facility, which shows and identifies the following information. If documents to this effect do not exist yet, please indicate this but provide the information that does exist and the plan and timeline to finalize the documentation. All documentation must be provided to the Department by November 14, 2014 in order to be a registered manufacturer: 1) The location and square footage of the area where Cannabis is to be grown; 2) The square footage of the areas where Cannabis is to be harvested; 3) The square footage of the areas where the Medical Cannabis is to be produced and manufactured; 4) The square footage of the areas where Medical Cannabis is to be packaged and labeled; 5) The square footage of the overall production facility; 6) The square footage and location of areas to be used as storerooms or stockrooms; 7) The location of any approved safes or approved vaults that are to be used to store Medical Cannabis; 8) The location of the toilet facilities; 9) The location of all break rooms and personal belonging lockers; and 10)The locations of all areas that may contain Medical Cannabis or Cannabis products that shows walls, partitions, counters and all areas of ingress and egress. Said diagram must also reflect all production, propagation, vegetation, flowering, harvesting, storage, and manufacturing areas. 11)The locations of any business operations on the property that will not be related to the production and distribution of medical cannabis 12)A11 security equipment and apparatus. i. An estimated duration start date for construction if the applicant is registered as a manufacturer of medical cannabis; j. A site development and construction plan identifying the duration of Rev. 08/01/2014 All Content Subject to Change Page 13 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers the construction and the completion date; k. Do you plan to operate any of your operations ata temporary site prior to your manufacturing facility being complete? If so provide all of the above.information for the temporary site 1. The location of all proposed distribution facilities; m. The dates when each distribution facility will be operational n. Any signage, lettering, text and graphic materials that will be shown on the exterior of the proposed production facility; o. Photographs of the surrounding neighborhood and businesses within 500 feet of the distribution facility, sufficient to evaluate the proposed facility's compatibility with commercial or residential structures already constructed, or under construction, within the surrounding area; p. A map that identifies all places used primarily for religious worship, public or private schools, convents, charitable institutions whether supported by private or public funds, hospital or veterans' homes, or any camp or military establishment that are within 1000 feet of the proposed distribution facility location; and 3. Cultivation Facility Please provide the following information specific to the cultivation facilities: a. Explanation of how the cultivation facilities will be secured to minimize the potential for theft or diversion of cannabis plants, cultivation materials and byproducts b. The process that the producer will take to ensure that access to the production facility premises will be limited only to employees and authorized personnel c. Provide a detailed description of the steps that would be taken in the event theft or diversion of materials does occur at the cultivation facility d. Explanation of how the cultivation facilities will be made to be a safe environment of employees working in and around the facilities e. Explanation of expected resource usage and disposal at the facility including power and water f. Any air treatment or other system that will be installed and used to reduce off-site odors g. Explanation of previous experience developing new cultivation facilities 4. Distribution Facilities Please provide the following information specific to the distribution facilities: Rev. 08/01/2014 All Content Subject to Change Page 14 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers a. Explanation of how the distribution facilities will be secured to minimize the potential for theft or diversion of medical cannabis products both usable and expired b. The process that the producer will take to ensure that access to the distribution facility premises will be limited only to employees and patients and caregivers c. Provide a detailed description of the steps that would be taken in the event theft or diversion of product does occur at any of the distribution facilities d. Explanation of how the distribution facilities will be made to be a safe environment of employees working -in and around the facilities e. Explanation of previous experience developing new product distribution sites C. PRODUCT DEVELOPMENT 1. Medical Cannabis Cultivation Please provide the following information specific to the cultivation of medical cannabis: a. Describe the experience of the applicant in agriculture required to produce pharmaceutical grade Cannabis. For purposes of this response, you may include the experience of any person employed by the applicant, including the person's name and position with the applicant. b. A detailed description of the applicant's cultivation process, with a focus on minimizing the risk of exposure to contaminants. c. Describe the cultivation methods that are expected to be employed, including the growing medium and the approach to cultivate consistent medical cannabis d. Describe the documentation of a plant or batches of plants through the growing process to allow for product traceability to support product recalls or notifications in the event ari issue is found with a plant or batch of plants e. Describe the protocol that will be employed if a fungal or pest outbreak were to occur to both address the issue and resume / restart cultivation f. Describe the expected usage of chemicals including fertilizers, fungicides, herbicides, insecticides including the conditions or protocols in which such chemical would be utilized g. Describe the documentation and record keeping of the use of chemicals Rev. 08/01/2014 All Content subject to Change Page 15 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at:.health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers h. Describe how any applied chemicals (fertilizers, pesticides, etc.) will be controlled from becoming part of the final product or how the final product will meet FDA standards for those chemicals. i. Describe who will be certified to apply pesticides at the manufacturing facility and how they will be reviewed to ensure that all licenses and recertification requirements are met according to Minnesota Pesticide Laws (Minnesota Statutes Chapter 1813) as well as FDA and EPA regulations 2. Medical Cannabis Product Manufacturing Please provide the following information specific to the cultivation of medical cannabis: a. Describe the experience of the applicant in manufacturing of finished medication. For purposes of this response, you may include the experience of any person employed by the applicant, including the person's name and position with the applicant. In particular, cite any experience the applicant may have in turning raw plant material into medication. b. A detailed description of protocol for turning the raw plant into acceptable medical cannabis, including: 1) the equipment the applicant will be using in its manufacturing protocol, including any policies or procedures relating to cleaning and maintenance 2) Calculation of yield process 3) Sampling and testing of in -process materials and drug products 4) Timeline of production process 5) Controls of microbiological contamination 6) Disposal of byproducts 7) Sampling and testing of final products 8) Stability testing 9) Record keeping process 10) Expiration dating 11) Packaging and labeling process c. Explain the intended plan to store, devitalize propagating parts (seeds) and dispose of plant materials left -over after the resources for development of medical cannabis products have been extracted. d. Describe the expected interaction and relationship between the certified laboratory responsible for testing the accuracy of the final medical cannabis products including expected frequency and volume of testing e. An explanation of how the applicant will limit employee exposure to Rev. 08/01/2014 Page 16 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabls.RFA@state.rnn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers potentially unsafe chemicals or other unsafe conditions f. Describe the documentation of a plant and plant extract through the process to allow for product traceability to support product recalls or notifications in the event an issue is found with a plant, batch of plants or plant extract g. A detailed description of the controls the applicant will have over the components of the medication and any product containers D. OPERATIONS 1. Cultivation Operations Please provide the following information: a. Describe the expected hours of operation for the cultivation facility b. Describe the maximum and minimum number of staff expected to be working at the cultivation facility at any one time c. Describe the experience expectations of staff working in the cultivation facilities and whether you expect the staff to be full time employees or part time employees or contractors d. Describe the training that will be provided to cultivation facility staff e. A list of all expected cultivation staff (employees or contractors) and their qualifications f. Describe how you will ensure that employees and staff are at least 21 years of age and have not been convicted of a disqualifying felony offense 2. Manufacturing Operations Please provide the following information: a. Describe the expected hours of operation for product manufacturing b. Describe the maximum and minimum number of staff expected to be working in the manufacturing facility at any one time c. Describe the experience expectations of staff working in manufacturing and whether you expect the staff to be full time employees or part time employees or contractors d. Describe the training that will be provided to manufacturing staff e. To the extent known, provide a list of all expected manufacturing staff (employees or contractors) and their qualifications f. Describe how you will ensure that employees and staff are at least 21 years of age and have not been convicted of a disqualifying felony offense 3. Distribution Facility Operations Rev. 08/01/2014 All Content Subject to Change Page 17 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Please provide the following information: a. Describe the expected hours of operation for the distribution facilities b. Describe the maximum and minimum number of staff expected to be. working at a distribution facility at any one time c. Describe the experience expectations of staff working at distribution facilities and whether you expect the staff to be full time employees or part time employees or contractors d. Describe the training that will be provided to distribution staff e. Describe the tools and information that will be provided to distribution site pharmacists to provide patient and caregiver guidance on medical cannabis products and dosages for their conditions f. Describe the tools and information that will be provided to distribution site pharmacists to provide patients and caregivers information on potential drug interactions and side affects g. Describe the tools, information and training that will be provided to distribution site staff and pharmacists regarding documentation and notification of MDH of adverse events potentially attributable to medical cannabis h. To the extent known, provide a list of all expected distribution staff (employees or contractors) and their qualifications i. Describe how you will ensure that employees and staff are at least 21 years of age and have not been convicted of a disqualifying felony offense 4. Product Transportation Please provide the following information: a. Provide a detailed description of the proposed method of transportation of medical cannabis products b. Provide a detailed description of the proposed method to minimize the risk of diversion or theft of medical cannabis during its transport from the manufacturing site to the distribution sites c. Provide a detailed description of the protocol that will be employed if medical cannabis is diverted or stolen during the transport to a distribution site d. To the extent known, provide a list of all expected transportation staff (employees or contractors) and their qualifications e. Describe how you will ensure that employees and staff are at least 21 years of age and have not been convicted of a disqualifying felony offense 5. Inventory Management Rev. 0810112014 All Content Subject to Change Page 18 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Please provide the following information: a. Describe the processes that will be utilized to manage medical cannabis inputs (including plant matter, chemicals, machinery, etc.) b. Describe the processes that will be utilized to manage medical cannabis final product inventory (at all locations) 6. Technology Usage Please provide the following information: Describe the computer systems that will be utilized to manage all of the medical cannabis operations from cultivation to manufacturing to distribution 7. Disaster Recovery Please provide the following information: a. In the event a disaster (fire, flood, tornado, etc.) occurs at the cultivation and manufacturing facility explain the steps and timeline to resume operations and minimize the potential impact to patients b. In the event a disaster (fire, flood, tornado, etc.) occurs at a distribution site explain the steps and timeline to resume operations and minimize the potential impact to patients E. BUSINESS PLAN A manufacturer shall operate in accordance with the business plan submitted to, and approved by, the Department as part of the application. 1. Business Expectations Please provide business plan that shows the following information: a. The applicant's expected production capacity, including any ability of the applicant to expand capacity within the approved production facility b. All Medical Cannabis products intended to be offered by the producer during the first year of operation and, for each product, provide a sample of the proposed label and identify the types of packaging Rev. 08/01/2014 All Content Subject to Change Page 19 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers c. Expected product pricing in each of the first. 3 years of operations d. Expected number of customers in each of the first 3 years of operations 2. Marketing Plan Please provide a marketing plan that includes the following information: a. Any web templates and educational materials such as brochures, posters, or promotional items b. Expected outreach, media, events or promotional activities to communicate medical cannabis to physicians c. Expected outreach, media, events or promotional activities to communicate medical cannabis to patients and caregivers F. OWNERSHIP AND FINANCIAL STRUCTURE All applicants must provide the following documents: 1. The articles of incorporation; articles of association; charter; by-laws; partnership agreement; any agreements between any two or more members of the applying organization that relate in any manner to the assets, property or profit of the applicant; or any other comparable documents that set forth the legal structure of the applicant or relate to the organization, management or control of the applicant; 2. Current organizational charts that include position descriptions and the names and resumes of persons holding each position to the extent such positions have been filled. 3. The resumes of each person listed on the organizational chart setting out the employee's particular skills, education, experience or significant accomplishments that are relevant to the position; 4. Copies of all compensation agreements with investors, board members, directors, owners, officers, other management. For purposes of this RFA, a compensation agreement includes any agreement that provides, or will provide, a benefit to the recipient whether in the form of salary, wages, commissions, fees, stock options, interest, bonuses or otherwise; 5. A listing of any criminal history and civil litigation (as a plaintiff or defendant) for all individuals identified in items 2, 3 and 4 above. Rev. 08/01/2014 All Content Subject to Change Page 20 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers 6. A description of the nature, type, terms, covenants and priorities of all outstanding bonds, loans, mortgages, trust deeds, pledges, lines of credit, notes, debentures or other forms of indebtedness issued or executed, or to be issued or executed, in connection with the opening or operating of the proposed production facility; 7. Audited financial statements for the previous three (3) fiscal years, which shall include, but not be limited to, an income statement, balance sheet, statement of retained earnings or owners' equity, statement of cash flows, and all notes to such statements and related financial schedules, prepared in accordance with generally accepted accounting principles, along with the accompanying independent auditor's report. If the audited financial statements are more than three months old please provide an affidavit indicating that there are no material changes subsequent to the most recently submitted financial statements. If the applicant was formed within the year preceding this application, provide certified financial statements for the period of time the applicant has been in existence and any pro forma financials used for business planning purposes; 8. Complete copies of all federal, state and foreign (with translation) tax returns filed by the applicant for the last three years, or for such period the applicant has filed such returns if less than three years; and 9. Complete copies of the most recently filed federal, state and foreign (with translation) tax returns filed by each owner / investor. G. BONUS POINTS Applicants may provide information related to any or all of the categories below with their application. Should the applicant be awarded a registration from the Department; their commitments in a bonus category shall become a condition of their registration. If a violation of a condition occurs, it may be _ deemed a material breach and the Department may assess a penalty or seek suspension or revocation of the registration. Employee Working Environment Plan: Describe any plans you have to provide a safe, healthy and economically beneficial working environment for your employees, including, but not limited to, your plans regarding workplace safety and environmental standards, codes of conduct, healthcare benefits, educational benefits, retirement benefits, Rev. 0810112014 All Content Subject to Change Page 21 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers and wage standards. 2. Compassionate Need Plan: Describe any compassionate need program you intend to offer. Include in your response: • The protocols for determining which patients will qualify for the program; • The discounts available to patients eligible for the compassionate need program; • The names of any other organizations, if any, with which you intend to partner or coordinate in connection with the compassionate need program, including any manufacturer's distribution site facility applicant; and • Any other information you think may be helpful to the Department in evaluating your compassionate need program. 3. Research Plan:, Provide the Department with a detailed proposal regarding a plan to assist MDH conduct or facilitate a scientific study or studies related to the medicinal use of Cannabis. 4. Community Benefits Plan: Provide the Department with a detailed description of any plans you have to give back to the community either at a state or local level if awarded a Manufacturer Registration. 5. Substance Abuse Prevention Plan: Provide a detailed description of any plans you will undertake, if awarded a Manufacturer Registration, to combat substance abuse in Minnesota, including the extent to which you will partner, or otherwise work, with existing substance abuse programs. 6. Environmental Plan: Describe any efforts you will take to reduce the ecological footprint of your production facility and other business operations such as plans to use renewable energy sources. 7. Health Equity: Describe any efforts you will take to reduce health disparities in the state of Minnesota as part of your business operations. H. CONCLUSION Provide a brief summary (no longer than two double-spaced pages) of why the applicant feels their application and proposal is the best choice Rev. 08/01/2014 All Content Subject to Change Page 22 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers for the State of Minnesota. In addition the conclusion should include the following: 1. The name, telephone number and email address for whoever will be responsible for responding to any questions that arise during the evaluation process. 2. Signatures of the principle owners and operational decision makers for the organization. Rev. 08/01/2014 Page 23 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Evaluation and Selection Procedures Overview & Timeline The Department will conduct a comprehensive, fair, and impartial evaluation of all applications received in response to this RFA. This review will involve the following process: 1. Intent to Apply Letter Submission 2. Application Completeness and Pass/Fail Criteria Evaluation 3. Application Evaluation a. Review of Applications b. Presentations — Optional c. Scoring of Applications 4. Selection of Semi-finalists 5. Site Visits 6. Selection of 2 Manufacturers Below is a graphical depiction of the process and the points during the process that some applicants will be eliminated from consideration. All Applications Rev. 08/01/2014 1nent? - 4plirzt- complete? Bass/Fail criteda? Application Fie? All Complete Applications [App.firring Semi-finalists finaiScoring Registered Manufacturers Page 24 of 29 All Content subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers 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 Finalists Selected — November 17 — 26, 2014 • 2 Manufacturers Registered — December 1, 2014 Application Completeness and Pass/Fail Criteria All applications will be assessed to determine whether they meet the mandatory qualification criteria set forth below. Be aware: with the exception of the bonus categories, all requested items are mandatory unless the request indicates otherwise. If an applicant has no experience or plan relative to a specific area, the applicant's RFA response document should clearly indicate so. Providing no response at all may be grounds for disqualification prior to the review and scoring of the application. MDH, however, reserves the right to waive minor irregularities or to request clarifications, modifications or amendments to an application, providing such application substantially complies with the RFA. Mandatory Qualification Criteria The Department will only review and score applications that: • Preceded by an Intent to Apply letter submitted prior to its due date (September 19, 2014); • Are submitted on or before the submission deadline with the application fee; Fully respond to all mandatory items in the RFA; Do not contain significant inconsistencies or inaccuracies; Include the appropriate number of copies (20), plus a CD with a searchable PDF copy of the complete submission; and Rev. 08/01/2014 Page 25 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Contain all required signatures and contact information; Successfully Passes all Pass/Fail Criteria (this criteria has NOT been finalized and may change, the items listed below are potential examples): o Applicant has secured or provisionally secured (letter from current property owner is sufficient) ownership or lease agreements for the manufacturing facility o Applicant contains experience cultivating plants in a greenhouse environment o Applicant contains experience in commercial manufacturing of pharmaceuticals, medical products or food products o Applicant contains previous business ownership and management experience o Applicant has experience owning or managing a business that required 24 hour security monitoring If an application response meets all of the above criteria then it will proceed to the next level of evaluation and scoring. Evaluation Criteria The evaluation of applications that meet the mandatory qualification criteria will proceed to be scored by the Evaluation Committee. The application response will be reviewed and scored according to the quality of its responses to the requirements set out in the RFA. While a maximum score of 1000 (1100 if all Value Add items are included) is possible, proposals must achieve a minimum score of 750 points to be considered for an award of a Manufacturer Registration. If an insufficient number of applications obtain a score of at least 750 to award one or both of the Manufacturer Registrations, the Department may request modifications from applicants whose scores are close to 750, as determined by the Department, so as to render the applications acceptable. Alternately, if the Department determines that sufficient modifications cannot be made to raise enough applications to an acceptable level, in either or both Service Areas, the Department may re -issue the RFA. The number of points in each Application Section (below) is the maximum number of points that may be awarded for each of the corresponding components of the RFA. For each category, the applicant's score will be based on the totality of the response to the corresponding RFA section. Rev. 08/01/2014 All Content Subject to Chargee Page 26 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers 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 In conducting its evaluation of each of the criteria, the Department may conduct interviews, contact references, conduct background checks, contact state regulators in any other state(s) where the applicant, applicant's investors or others associated with the applicant have engaged in, or sought to be engaged in, the state's medical cannabis program and visit the location of the proposed production facility or of other related businesses associated with the applicant or the applicant's investors or key personnel. Presentations As part of the evaluation process, the applicant or the Department may request a 90 minute in-person or video conference presentation to the Evaluation Committee. The presentations will not be scored separately. They will be used to more fully inform each of the Application Section scoring areas noted above. Please specify in your application whether you want to make such a presentation. If the applicant chooses not to exercise this option the Department will review the application and determine if the Department wants to require a presentation by the applicant. Semi-finalist Selection After the Presentations and Application scoring are complete the Evaluation Committee will select up to 3 Semi-finalists from each service area to proceed in the evaluation process. The Semi-finalists will be identified based on receiving one of the 3 highest scores in their self -identified service area. Rev. 08/01/2014 All Content Subject to Change Page 27 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers Semi-finalist Site Visits Once the Semi-finalists have been determined the Department will request a site visit of the applicant's existing (or previous) cultivation, manufacturing and/or distribution operations as evidence of their expertise. A separate evaluation will be conducted based on the site visit. The Site Visit will evaluate a number of areas to inform the manufacturer evaluation process. Some of the evaluation sections are identified below (these are NOT final and are likely to change prior to final RFA publication) Site Visit Section Points Available Cultivation &/or manufacturing processes TBD Facility Safety TBD Facility Security TBD TBD TBD Total TBD Please indicate in your application the existing operations that would serve as your site visit location including their location (address) and a contact to arrange for a potential site visit. If the applicant has no current operations a site visit of the prospective manufacturing and distribution locations can serve as an alternative but may not be scored as high due .to the lack of demonstrable experience. Final Selection After completing the site visits and associated scoring the full Evaluation Committee will review the semi-finalist application scores and site visit scores. The Evaluation Committee shall 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 t o the process of securing Manufacturer Registrations. If issues arise during the process of registering a Finalist and registration agreement is unable to be secured by November 24, 2014 the Department will proceed to engage in registration of the second highest scoring Semi-finalist applicant for the Service Area. If the highest ranked applicants in both service areas have overlapping investors, directors, owners, officers or other high-level employees, the Department shall award the Manufacturer Registration to the next highest ranked applicant in one of the service areas without such an overlap. Rev. 08/01/2014 Page 28 of 29 All Content Subject to Change The Minnesota Department of Health encourages feedback on this draft RFA at:.health.cannabis.RFA@state.mn.us Department of Health - Office of Medical Cannabis Request for Application for the Registration of Medical Cannabis Manufacturers If the applicant submits an application for each Service Area and is the highest applicant for both Service Areas, the Department shall give the applicant the option to select which Service Area it wishes to be registered for. Upon selecting the successful applications, the Department shall notify all applicants of their status -in writing. The Department's decision to award or not award a registration to an applicant shall be final. Rev. 08/01/2014 All Content Subject to Change Page 29 of 29 The Minnesota Department of Health encourages feedback on this draft RFA at: hea1th.cannab1s.RFA@state.mn.us