15.03.140 Application for Initial Registration as a Registered Entity

(a) Businesses eligible to obtain registration as registered entities must be owned and controlled by Tribal Members. "Ownership" is defined as having at least 51% tribal member ownership. "Controlled" means that all material decisions of the business must be made by the Tribal Member owners.

(b) In order to operate as a registered entity, an entity must file an application on forms or in a manner prescribed by the Authority. The application shall set forth or be accompanied by the following:

(1) The name, address, phone and email address of the applicant;

(2) Identification of all real property, buildings and facilities that will be used in manufacturing, as defined in Subchapter 5, and dispensing of the medical marijuana products;

(3) Identification of all equipment that will be used to carry out the manufacturing, processing, transportation, distributing, sale and dispensing activities described in the application and operating plan;

(4) An operating plan that includes a detailed description of the applicant's manufacturing processes, transporting, distributing, sale and dispensing policies or procedures. The operating plan shall also include:

(A) detailed description of any devices used with approved medical marijuana products to be offered or sold by the registered entity;

(B) policies and procedures related to security and control measures that will be in place to prevent diversion, abuse, and other illegal or unauthorized conduct relating to medical marijuana and are consistent with provisions set forth in this part;

(C) a standard operating procedure manual for all methods used from cultivation of the medical marijuana through packaging, sealing and labeling of each lot of medical marijuana product. The procedures shall include use of good agricultural practices (GAPs). Standard operating procedures shall be able to be validated to demonstrate that the applicant will be able to produce and dispense consistent and reproducible medical marijuana product such that, for each form of each brand produced, there is homogeneity, absence of contamination and reproducibility of the brand profile in each lot as defined in this chapter;

(D) quality assurance plans, including but not limited to plans to detect, identify and prevent dispensing errors;

(E) policies and procedures to document and investigate approved medical marijuana product returns, complaints and adverse events, and to provide for rapid voluntary or involuntary recalls of any lot of medical marijuana product. Such policies and procedures shall include a plan for any retesting of returned approved medical marijuana products, storage and disposal of marijuana and any manufactured medical marijuana products not passing requirements, and a requirement that adverse events and total recalls are reported to the Authority within twenty-four hours of their occurrence;

(F) a quality assurance program to track contamination incidents and document the investigated source of such incidents, and the appropriate corrective action(s) taken;

(G) detailed description of plans, procedures and systems adopted and maintained for tracking, record keeping, record retention and surveillance systems, relating to all medical marijuana at every stage including cultivating, possessing of marijuana, and manufacturing, delivery, transporting, distributing, sale and dispensing by the proposed registered entity;

(H) proposed hours of operation for the manufacturing and dispensing facilities.

(5) Copies of the organizational and operational documents of the applicant, including but not limited to, as applicable: the certificate of incorporation, bylaws, articles of the entity, partnership agreement, operating agreement and other applicable documents and agreements, and all amendments thereto;

(6) The name, residence address and title of each of the board members, officers, managers, owners, partners, principal stakeholders, directors and any person or entity that is a member of the applicant.

(7) A statement that the applicant is able to comply with all applicable tribal laws and regulations relating to the activities in which it intends to engage under the registration;

(8) Copies of all applicable executed and proposed deeds, leases, and rental agreements or executed option contracts related to the entity's real property interests, that shows that the applicant possesses or has the right to use sufficient land, buildings, and other premises as specified in the application and equipment to properly carry on the activities for which registration is sought. a financial statement setting forth all elements and details of any business transactions connected with the application, including but not limited to all agreements and contracts for consultation and/or arranging for the assistance in preparing the application;

(9) Architectural program and sketches of the applicant's proposed manufacturing and dispensing facility(ies) including the following:

(A) site plans;

(B) schematic architectural and engineering design drawings and single line sketches in an appropriate scale showing the relationship of various buildings to each other, room configurations, major exit corridors, exit stair locations, and circulation along with existing buildings if additions or alterations are part of the project;

(C) outline specifications for the type of construction proposed including a description of energy sources, type and location of engineering systems proposed for heating, cooling, ventilation and electrical distribution, water supply and sewage;

(D) a security plan indicating how the applicant will comply with the security requirement in this chapter and any other applicable law, rule, or regulation; and

(E) the registered entity shall submit detailed floor plans indicating the activities performed in each area and security plans (physical and cyber) consistent with the requirements of Subchapter 7 [Manufacturing];

(10) A construction timetable;

(11) A statement as to whether the applicant, any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the board of directors of a corporate applicant, and corporate general partner had a prior discharge in bankruptcy or was found insolvent in any court action;

(12) If any controlling person of the applicant, any manager, any sole proprietor applicant, any general partner of a partnership applicant, any officer and member of the Advisory Board of directors of a corporate applicant, or corporate general partner or a combination of such persons collectively, maintains a ten percent interest or greater in any firm, association, foundation, trust, partnership, corporation, or other entity or if such entity maintains a ten percent interest or greater in the applicant, and such entity will or may provide goods, leases, or services to the registered entity, the value of which is or would be five hundred dollars or more within any one year, the name and address of the entity shall be disclosed together with a description of the goods, leases or services and the probable or anticipated cost to the registered entity;

(13) If the applicant is a corporate subsidiary or affiliate of another corporation, disclosure of the parent or affiliate corporation including the name and address of the parent or affiliate, the primary activities of the parent or affiliate, the interest in the applicant held by the parent or affiliate and the extent to which the parent will be responsible for the financial and contractual obligations of the subsidiary;

(14) The most recent certified financial statement of the applicant, audited by an independent certified public accountant and prepared in accordance with generally accepted accounting principles (GAAP) applied on a consistent basis, including a balance sheet as of the end of the applicant's last fiscal year and income statements for the past two fiscal years, or such shorter period of time as the applicant has been in operation;

(15) If construction, lease, rental or purchase of the manufacturing or dispensing facility has not been completed, a statement indicating the anticipated source and application of the funds to be used in such purchase, lease, rental or construction;

(16) A staffing plan for staff involved in activities related to the cultivation of marijuana, the manufacturing and/or dispensing of approved medical marijuana products and/or staff with oversight responsibilities for such activities, which shall include:

(A) a senior staff member with a minimum of one (1) year experience in good agricultural practices (GAP);

(B) a quality assurance officer who shall exercise oversight of the entity's practices and procedures and who has documented training and experience in quality assurance and quality control procedures;

(D) a requirement that all staff involved in the manufacturing be trained in and conform to general sanitary practices; and

(E) policies and procedures to ensure that the proposed registered entity shall not employ anyone who would come in contact with or handle medical marijuana who has been convicted of any felony of sale or possession of drugs, narcotics, or controlled substances;

(17) Any other information as may be required by the Authority.

(c) An application under this section may be amended while the matter is pending before the Authority, if approved by the Authority upon good cause shown.

(d) The applicant shall verify the truth and accuracy of the information contained in the application. The Authority, in its discretion, may reject an application if it determines that information contained therein is not true and accurate.