935 CMR, § 501.101

Current through Register 1536, December 6, 2024

Section 501.101 - Application Requirements

(1)New Applicants. An MTC applicant shall file, in a form and manner specified by the Commission, an application for licensure as an MTC. The application requirements outlined in 935 CMR 501.101(1) will apply to all MTC applications submitted on or after November 1, 2019. The application shall consist of three sections: Application of Intent; Background Check; and Management and Operations Profile, except as otherwise provided. The applicant may complete any section of the application in any order. Once all sections of the application have been completed, the application may be submitted. Application materials, including attachments, may be subject to release pursuant to M.G.L. c. 66, § 10 and M.G.L. c. 4, § 7, cl. 26.

(a)Application of Intent. An applicant for licensure as an MTC shall submit the following as part of the Application of Intent:

1. Documentation that the MTC is an entity registered to do business in Massachusetts and a list of all Persons or Entities Having Direct or Indirect Control. In addition, the applicant shall submit any contractual, management, or other written document that explicitly or implicitly conveys direct or indirect control over the MTC to the listed person or entity pursuant to 935 CMR 501.050(1)(b);

2. A disclosure of an interest of each individual named in the application in any Marijuana Establishment or MTC application for licensure or Licensee in Massachusetts;

3. Documentation disclosing whether any individual named in the application have past or present business interests in Other Jurisdictions;

4. Documentation detailing the amounts and sources of capital resources available to the applicant from any individual or entity that will be contributing capital resources to the applicant for purposes of establishing or operating the identified MTC for each License applied for. If any person or entity contributing initial capital, either in cash or in kind, would be classified as a Person or Entity Having Direct or Indirect Control, in exchange for the initial capital, they shall also be listed pursuant to 935 CMR 501.101(1)(a)1. Information submitted shall be subject to review and verification by the Commission as a component of the application process. Required documentation shall include:

a. The proper name of any individual or registered business name of any entity;

b. The street address; provided however, that the address may not be a post office box;

c. The primary telephone number;

d. Electronic mail;

e. The amount and source of capital provided or promised;

f. A bank record dated within 60 days of the application submission date verifying the existence of capital;

g. Certification that funds used to invest in or finance the MTC were lawfully earned or obtained; and

h. Any contractual or written agreement pertaining to a loan of initial capital, if applicable.

5. Documentation of a bond or an escrow account in an amount set by 935 CMR 501.105(16);

6. Identification of the proposed address for the License;

7. Documentation of a property interest in the proposed address. The proposed MTC shall be identified in the documentation as the entity that has the property interest. Interest may be demonstrated by one of the following:

a. Clear legal title to the proposed site;

b. An option to purchase the proposed site;

c. A legally enforceable agreement to give such title; or

d. Documentation evidencing permission to use the Premises.

8. Documentation in the form of a single-page certification signed by the contracting authorities for the municipality (or municipalities) and applicant evidencing that the applicant for licensure and host municipality in which the address of the MTC is located have executed a Host Community agreement;

9. Documentation that the applicant has conducted a community outreach meeting consistent with the Commission's Guidance for License Applicants on Community Outreach within the six months prior to the application submission date. If the MTC will be located in two locations under this License, the applicant shall hold separate and distinct community outreach meetings in each municipality. Documentation shall include:

a. Copy of a notice of the time, place and subject matter of the meeting, including the proposed address of the MTC, that was published in a newspaper of general circulation in the city or town at least 14 calendar days prior to the meeting;

b. Copy of the meeting notice filed with the city or town clerk, the planning board, the contracting authority for the municipality and local cannabis licensing authority, if applicable;

c. Attestation that at least one meeting was held within the municipality where the MTC is proposed to be located;

d. Attestation that at least one meeting was held after normal business hours;

e. Attestation that notice of the time, place and subject matter of the meeting, including the proposed address of the MTC, was mailed at least seven calendar days prior to the community outreach meeting to abutters of the proposed address of the MTC, and residents within 300 feet of the property line of the petitioner as they appear on the most recent applicable tax list, notwithstanding that the land of any such Owner is located in another city or town;

f. Information presented at the community outreach meeting, which shall include, but not be limited to:

i. The proposed address of the MTC with the declaration that the proposed MTC is a "Medical Marijuana Treatment Center";

ii. Information adequate to demonstrate that the location(s) will be maintained securely;

iii. Steps to be taken by the MTC to prevent diversion to minors;

iv. A plan by the MTC to provide reduced cost or free Marijuana to Patients with documented Verified Financial Hardship, as defined by the Commission. The plan shall outline the goals, programs, and measurements the MTC will pursue once licensed;

v. A plan by the Marijuana Establishment to positively impact the community;

vi. Information adequate to demonstrate that the location will not constitute a nuisance as defined by law; and

vii. An attestation that community members were permitted to ask questions and receive answers from representatives of the MTC.

10. A description of plans to ensure that the MTC is or will be compliant with local codes, ordinances, and bylaws for the physical address of the MTC, which shall include, but not be limited to, the identification of all local licensing requirements for the medical use of Marijuana;

11. A plan by the MTC to positively impact Areas of Disproportionate Impact, as defined by the Commission, for the purposes established in M.G.L. c. 94G, § 4(a1/2)(iv). The plan shall outline the goals, programs, and measurements the Marijuana Establishment will pursue once licensed. A Licensee may satisfy their positive impact plan requirement, in part, by donating to the Cannabis Social Equity Trust Fund at any time once licensed. The plan shall outline the goals, programs, and measurements the MTC will pursue once licensed.

12. In addition to donating to the Cannabis Social Equity Trust Fund, a Licensee may satisfy the remainder of their positive impact plan by complying with one or more of the following:

a. The Licensee has conducted 50 hours of educational seminars targeted to residents of Areas of Disproportionate Impact in one or more of the following: Marijuana cultivation, Marijuana Product manufacturing, Marijuana retailing, or Marijuana business training;

b. The Licensee can demonstrate that a majority of employees have a conviction or continuance without a finding for an offense under M.G.L. c. 94C or an equivalent conviction in Other Jurisdictions; or

c. The Licensee can demonstrate that in a year, at least one percent of its gross revenue or a minimum of 20 hours of each staff member's paid time is contributed to supporting persons from communities disproportionately harmed by Marijuana prohibition or an Area of Disproportionate Impact as determined by the Commission.

13. The requisite nonrefundable application fee pursuant to 935 CMR 501.005; and

14. Any other information required by the Commission.

(b)Background Check. Prior to an application being considered complete, each applicant for licensure shall submit the following information:

1. The list of individuals and entities in 935 CMR 501.101(1)(a)1.;

2. Information for each individual identified in 935 CMR 501.101(1)(a)1., which shall include:

a. the individual's full legal name and any aliases;

b. the individual's address;

c. the individual's date of birth;

d. a photocopy of the individual's driver's license or other government-issued identification card;

e. a CORI Acknowledgment Form, pursuant to 803 CMR 2.09: Requirements for Requestors to Request CORI, provided by the Commission, signed by the individual and notarized; and

f. any other authorization or disclosure, deemed necessary by the Commission, for the purposes of conducting a background check.

3.Relevant Background Check Information. All Persons and Entities Having Direct or Indirect Control, and those individuals and entities contributing 10% or more in the form of a loan, shall provide information detailing involvement in any of the following criminal, civil, or administrative matters:

a. A description and the relevant dates of any criminal action under the laws of the Commonwealth, or an Other Jurisdiction, whether for a felony or misdemeanor including, but not limited to, action against any health care facility or facility for providing Marijuana for medical or adult-use purposes, in which those individuals either owned shares of stock or served as board member, Executive, officer, director or member, and which resulted in conviction, or guilty plea, or plea of nolo contendere, or admission of sufficient facts;

b. A description and the relevant dates of any civil action under the laws of the Commonwealth, or an Other Jurisdiction including, but not limited to, a complaint relating to any professional or occupational or fraudulent practices;

c. A description and relevant dates of any past or pending legal or disciplinary actions in the Commonwealth or any other state against an entity whom the applicant served as a Person or Entity Having Direct or Indirect Control, related to the cultivation, Processing, distribution, or sale of Marijuana for medical or adult-use purposes;

d. A description and the relevant dates of any administrative action including any complaint, order, stipulated agreement or settlement, or disciplinary action, by the Commonwealth, or like action in an Other Jurisdiction including, but not limited to:

i. The denial, suspension, or revocation, or other action with regard to of a professional or occupational license, registration, or certification or the surrender of a license;

ii. Administrative actions with regard to unfair labor practices, employment discrimination, or other prohibited labor practices; and

iii. Administrative actions with regard to financial fraud, securities regulation, or consumer protection.

e. A description and relevant dates of actions against a license to prescribe or distribute controlled substances or legend drugs held by any Person or Entity Having Direct or Indirect Control that is part of the applicant's application, if any; and

f. Any other information required by the Commission.

(c)Management and Operations Profile. Each applicant shall submit, with respect to each application, a response in a form and manner specified by the Commission, which includes:

1. Detailed information regarding its business registration with the Commonwealth, including the legal name, a copy of the articles of organization and bylaws as well as the identification of any doing-business-as names;

2. A certificate of good standing, issued within the previous 90 days from submission of an application, from the Corporations Division of the Secretary of the Commonwealth;

3. A certificate of good standing or certificate of tax compliance issued within the previous 90 days from submission of an application, from the DOR;

4. A certificate of good standing, issued within the previous 90 days from submission of an application, from the DUA, if applicable. If not applicable, a written statement to this effect is required;

5. A proposed timeline for achieving operation of the MTC and evidence that the MTC will be ready to operate within the proposed timeline after notification by the Commission that the applicant qualifies for licensure;

i. Fraudulent billing practices;

ii. Past or pending legal or disciplinary actions in any other state against any officer, Executive, director, or board member of the applicant or its members, or against any other entity owned or controlled in whole or in part by them, related to the cultivation, Processing, distribution, or sale of Marijuana for medical purposes;

iii. Past or pending denial, suspension, or revocation of a license or registration, or the denial of a renewal of a license or registration, for any type of business or profession, by the Commonwealth or Other Jurisdictions, including denial, suspension, revocation, or refusal to renew certification for Medicaid or Medicare;

iv. Past discipline by, or a pending disciplinary action or unresolved complaint by the Commonwealth, or a like action or complaint by Other Jurisdictions, with regard to any professional license or registration of an Executive of the applicant, as well as by any member of the entity, if any; or

6. A description of the MTC's plan to obtain a liability insurance policy or otherwise meet the requirements of 935 CMR 501.105(10);

7. A detailed summary of the business plan for the MTC;

8. A detailed summary of operating policies and procedures for the MTC, which shall include, but not be limited to, provisions for:

a. Security;

b. Prevention of Diversion;

c. Storage of Marijuana;

d. Transportation of Marijuana;

e. Inventory procedures;

f. Procedures for quality control and testing of product for potential contaminants;

g. Personnel policies;

h. Dispensing procedures;

i. Recordkeeping procedures;

j. Maintenance of financial records; and

k. Diversity plans to promote equity among people of color, particularly Black, African American, Latinx, and Indigenous people, women, Veterans, persons with disabilities, and LGBTQ+ people, in the operation of the MTC. The plan shall outline the goals, programs, and measurements the MTC will pursue once licensed.

9. A detailed description of qualifications and intended training(s) for MTC agents who will be employees;

10. The Management and Operation Profile submitted in accordance with 935 CMR 501.101(1)(c) shall demonstrate compliance with the operational requirements set forth in 935 CMR 501.105 through 501.160, as applicable;

11. Disclosure of the proposed hours of operation, and the names and contact information for individuals that will be the emergency contacts for the MTC;

12. The identification of whether the MTC will perform home deliveries to Patients and Caregivers. If so, a detailed summary of the policies and procedures to ensure the safe delivery of Finished Marijuana Products to Patients and Caregivers, including procedures for how Individual Orders will be filled and procedures for reconciling Individual Orders at the close of the business day, shall be provided;

13. A detailed operation plan for the cultivation of Marijuana, including a detailed summary of policies and procedures for cultivation, consistent with state and local law including, but not limited to, the Commission's guidance in effect November 1, 2019;

14. A list of all products that MTC plans to produce, including the following information:

a. A description of the types and forms of Marijuana Products that the MTC intends to produce;

b. The methods of production;

c. A safety plan for the manufacture and production of Marijuana Products; and

d. A sample of any unique identifying mark that will appear on any product produced by the applicant as a branding device.

15. A detailed summary of the proposed program to provide reduced cost or free Marijuana to Patients with documented financial hardship; and

16. Any other information required by the Commission.

(2)Application Requirements for MTC Applicants that Submit an Application of Intent prior to November 1, 2019.

(a)Application of Intent. An applicant for an MTC License shall submit the following as part of the Application of Intent:

1. Documentation that it is an entity in good standing as specified in 935 CMR 501.050, as well as a list of all Executives of the proposed MTC, and a list of all members, if any, of the entity;

2. Documentation that it has at least $500,000 in its control and available, as evidenced by bank statements, lines of credit, or the equivalent, to ensure that the applicant has sufficient resources to operate. 935 CMR 501.101(2) may be fulfilled through demonstration of pooled resources among the individuals or entities affiliated with the applicant. If an entity is submitting more than one application, the capital requirement shall be $400,000 for each subsequent application;

3. An attestation signed by an authorized designee of the entity that if the entity is allowed to proceed to the Management and Operations Profile, the entity is prepared to pay a nonrefundable application fee as specified in the applicable notice;

4. The requisite nonrefundable application fee; and

5. Any other information required by the Commission.

(b)Management and Operations Profile. Within 45 days after receipt of an invitation to the Management and Operations Profile, the applicant shall submit a response in a form and manner specified by the Commission, which includes:

1. Detailed information regarding entity, including the legal name, a copy of the articles of organization and bylaws;

2. The name, address, date of birth, and resumes of each Executive of the applicant and of the members, if any, of the entity, along with a photocopy of their driver's licenses or other government-issued identification cards, and background check information in a form and manner determined by the Commission;

3. List of all Persons or Entities Having Direct or Indirect Control over the management or policies of the MTC;

4. A description of the MTC's plan to obtain a liability insurance policy or otherwise meet the requirements of 935 CMR 501.105(10);

5. A detailed summary of the business plan for the MTC;

6. An operational plan for the cultivation of Marijuana, including a detailed summary of policies and procedures for cultivation;

7. If the MTC intends to produce MIPs, a description of the types and forms of MIPs that the MTC intends to produce, and the methods of production;

8. A detailed summary of operating policies and procedures for the MTC, which shall include, but not be limited to, provisions for security, prevention of diversion, storage of Marijuana, transportation of Marijuana, inventory procedures, including plans for integrating any existing electronic tracking systems with the Seed-to-sale SOR, procedures for quality control and testing of product for potential contaminants, procedures for maintaining confidentiality as required by law, personnel policies, dispensing procedures, recordkeeping procedures, plans for patient education, and any plans for patient or Personal Caregiver Patient delivery;

9. A detailed summary of the MTC's policies and procedures for the provision of Marijuana to Registered Qualifying Patients with Verified Financial Hardship without charge or at less than the market price, as required by 935 CMR 501.050(1)(h);

10. A detailed description of all intended training(s) for MTC agents;

11. Evidence that the applicant is responsible and suitable to maintain an MTC. Information including, but not limited to, the following factors shall be considered in determining the responsibility and suitability of the applicant to maintain an MTC:

a. Demonstrated experience running a business;

b. History of providing healthcare services or services providing Marijuana for medical purposes, including provision of services in other states;

c. History of response to correction orders issued under the laws or regulations of the Commonwealth or other states;

d. Whether the applicant complies with all laws of the Commonwealth relating to taxes and child support and whether the applicant will have workers' compensation and professional and commercial insurance coverage;

e. A description and the relevant dates of any criminal action under the laws of the Commonwealth, or Other Jurisdictions, whether for a felony or misdemeanor including, but not limited to, action against any health care facility or facility for providing Marijuana for medical- or adult-use purposes, in which those individuals either owned shares of stock or served as board member, Executive, officer, director or member, and which resulted in conviction, or guilty plea, or plea of nolo contendere, or admission of sufficient facts;

f. A description and the relevant dates of any civil action under the laws of the Commonwealth, or Other Jurisdictions including, but not limited to, a complaint relating to any professional or occupational or fraudulent practices;

i. Fraudulent billing practices;

g. A description and relevant dates of actions against a license to prescribe or distribute controlled substances or legend drugs held by any Person or Entity Having Direct or Indirect Control that is part of the applicant's application, if any; and

h. Any attempt to obtain a registration, license, or approval to operate in any state by fraud, misrepresentation, or the submission of false information;

12. Any other information required by the Commission.

(c)Siting Profile. Within 12 months after receipt of an invitation to submit the Siting Profile, the applicant shall submit a response in a form and manner specified by the Commission, which includes:

1. The county, city or town in which the proposed MTC would be sited, and if known, the physical address of the proposed MTC. If Marijuana will be cultivated or MIPs will be prepared at any location other than the dispensing location of the proposed MTC, the physical address of the one additional location where Marijuana will be cultivated or MIPs will be prepared, if known;

2. The applicant shall provide evidence of interest in the subject property or properties. Interest may be demonstrated by one of the following:

a. Clear legal title to the proposed site;

b. An option to purchase the proposed site;

c. A legally enforceable agreement to give such title; or

d. Documentation evidencing permission to use the premises;

3. Documentation in the form of a single-page certification signed by the contracting authorities for the municipality (or municipalities) and applicant evidencing that the applicant for licensure and host municipality in which the address of the MTC is located have executed a Host Community agreement(s);

4. A description of plans to ensure that the MTC is or shall be compliant with local codes, ordinances, and bylaws for the physical address of the MTC and for the physical address of the additional location, if any, including the identification of all local licensing bylaws or ordinances for the medical use of Marijuana;

6. Any other information required by the Commission.

(3)CMO License Requirements. MTC applicants seeking to operate a Marijuana Establishment shall also comply with 935 CMR 500.101: Application Requirements.

(4)Pre-verification and Verification of Social Equity Businesses.

(a) Pre-verification of Eligibility as a Social Equity Business is applicable to individuals and entities who, as a business entity, have not been licensed as a Marijuana Establishment.

1. An individual or entity may file, in a form and manner specified by the Commission, an application for Pre-verification of Eligibility as a Social Equity Business. Once the Commission has confirmed that the application is complete, Commission staff will review the application to determine whether the individual or entity is eligible as a Social Equity Business. After making this determination, the Commission will notify the individual or entity whether it has been determined to be a pre-verified Social Equity Business.

2. The Commission shall act on an application for Pre-verification of Eligibility as a Social Equity Business within 30 days of receipt.

3. Pre-verified Social Equity Businesses certified by the Commission may request that the Commission provide confirmation of pre-verified status to a Host Community.

(b) Verification of Eligibility as a Social Equity Business is applicable to individuals and entities who, as a business entity, are licensed as a Marijuana Establishment.

1. A Marijuana Establishment may file, in a form and manner specified by the Commission, an application for Verification of Eligibility as a Social Equity Business. Once the Commission has confirmed that the application is complete, Commission staff will review the application to determine whether the Marijuana Establishment is a Social Equity Business or is eligible as a Social Equity Business. After making this determination, the Commission will notify the Marijuana Establishment whether it has been determined to be a verified Social Equity Business.

2. The Commission shall act on an application for Verification of Eligibility as a Social Equity Business within 30 days of receipt.

(c) If there has been a change in qualifying criteria after the submission of an application, or after receiving pre-verification, the individual or entity pre-verified or verified as a Social Equity Business shall revise this information and attest to the change in a form and manner determined by the Commission. The individual or entity shall also notify the Host Community of a change in qualifying criteria to its application or its pre-verified status as a Social Equity Business, as applicable.

(d) List to be provided to the Department of Revenue. The Commission shall provide the Department of Revenue with a list of Social Equity Businesses 30 days within pre-verification or Verification of Eligibility as a Social Equity Business by the Commission.