W. Va. Code R. § 64-109-6

Current through Register Vol. XLI, No. 45, November 8, 2024

Section 64-109-6 - Initial permit application

6.1. The bureau shall publish in the State Register and on the bureau's website notice of initial permit application availability and the time frame during which initial permit applications will be accepted.

6.1.a. An applicant may only use the initial permit application form prescribed by the bureau made available on its web site.

6.1.b. An applicant must submit an initial permit application to the bureau in a manner prescribed by the initial permit application instructions.

6.1.c. An initial permit application received from an applicant after the time frame during which the bureau is accepting applications shall be rejected by the bureau and returned to the applicant without further consideration along with the return of fees submitted by the applicant with the application.

6.2. In addition to the requirements in section 4 (General requirements for application), the applicant must provide the bureau with the following information in the initial permit application:

6.2.a. The legal name of the applicant;

6.2.b. Certified copies of the applicant's organizational documents, if applicable, and if the applicant was not organized in this state, evidence that it is authorized to conduct business in this state;

6.2.c. The physical address of the applicant's proposed site and facility, including the following, as applicable:

6.2.c.1. Evidence of the applicant's clear legal title to or option to purchase the proposed site and the facility;

6.2.c.2. A fullyexecuted copy of the applicant's unexpired lease for the proposed site and facility that includes the consent by the property owner to the use by the applicant of that site and facility on the proposed site for, at a minimum, the term of the initial permit; or

6.2.c.3. Other evidence satisfactory to the bureau that shows the applicant has the authority to use the proposed site and facility as a site and facility for, at a minimum, the term of the permit.

6.2.d. Evidence that the applicant is or will be in compliance with the zoning requirements of any municipality in which the applicant intends to operate.

6.2.e. The following apply to the proposed facility:

6.2.e.1. If the facility is in existence at the time the initial permit application is submitted to the bureau, the applicant must submit plans and specifications drawn to scale for the interior of the facility.

6.2.e.2. If the facility is in existence at the time the initial permit application is submitted to the bureau, and the applicant intends to make alterations to the facility, the applicant must submit renovation plans and specifications for the interior and exterior of the facility to be altered.

6.2.e.3. If the facility is not in existence at the time the initial permit application is submitted to the bureau, the applicant must submit a plot plan that shows the proposed location of the facility and an architect's drawing of the facility, including a detailed drawing, to scale, of the interior of the facility.

6.2.f. The name, residential address, date of birth, title, and a curriculum vitae of each principal, operator, financial backer, and employee of the applicant, or of any person holding an interest in the applicant's proposed site or facility, including:

6.2.f.1. A verification of identity that is satisfactory to the bureau;

6.2.f.2. Evidence of good moral character and reputation of each principal, operator, financial backer, or employee; and

6.2.f.3. A copy of a criminal history records check for each individual performed in accordance with section 7 (Background checks). This paragraph does not apply to an applicant who is an owner of securities in a publicly traded company if the bureau determines that the owner of the securities is not substantially involved in the activities of the applicant.

6.2.f.4. An affidavit from each principal or operator of the applicant setting forth the following:

6.2.f.4.A. Any position of management or ownership held during the 10 years preceding the filing date of the initial permit application of a controlling interest in any other business in this state or any other jurisdiction involving the manufacturing or distribution of medical cannabis or a controlled substance; and

6.2.f.4.B. Whether the principal, operator, or financial backer has been convicted of a felony criminal offense.

6.2.g. If a principal, operator or financial backer is a corporation or limited liability company:

6.2.g.1. The names, residential addresses, titles, and the curricula vitae of each principal of the corporation or limited liability company;

6.2.g.2. A certified copy of the filed articles of incorporation of the corporation or filed certificate of organization of the limited liability company; and

6.2.g.3. Unless the corporation or limited liability company is a publicly traded company, the names and mailing addresses of all persons owning securities in the corporation or membership interests in the limited liability company.

6.2.h. If a principal, operator, or financial backer is a general partnership, limited partnership, limited liability partnership, or limited liability limited partnership:

6.2.h.1. The names, residential addresses, titles, and the curricula vitae of each partner and general partner of a general partnership, limited partnership, limited liability partnership, or limited liability limited partnership, and if any of the partners is a corporation or a limited liability company, the names, residential addresses, titles, and short version of the curricula vitae of each principal of that corporation or limited liability company;

6.2.h.2. A certified copy of its filed certificate of limited partnership or other formation document, if applicable;

6.2.h.3. A certified copy of its partnership agreement; and

6.2.h.4. Unless the entity is a publicly traded company, the names, and mailing addresses of each of its partners.

6.2.i. Evidence that the applicant is responsible and capable of successfully establishing and operating a facility, including the following:

6.2.i.1. Demonstrated experience, if any, running a for-profit or nonprofit organization or other business within this state or any other jurisdiction, and the nature of the business conducted by the organization;

6.2.i.2. History relating to a similar license, permit, or other authorization in other jurisdictions, including provisional licenses, suspensions, revocations, or disciplinary actions, including civil monetary penalties or warnings;

6.2.i.3. History of response to sanctions, disciplinary actions, or civil monetary penalties imposed relating to any similar license, permit, or other authorization in another jurisdiction, and the plans of correction or other responses made to those actions;

6.2.i.4. Evidence that the applicant and its principals, and other persons affiliated with the applicant identified by the bureau, is in compliance with all the laws of the state regarding the payment of state taxes as shown on the tax clearance certificates issued by the State Department and Workforce West Virginia under section 4;

6.2.i.5. Evidence of any felony criminal action under the laws of the state or any other state, the United States or a military, territorial, or tribal authority, against a principal, operator, financial backer, or employee, or which involved the possession, transportation, or sale of illegal drugs, or which related to the provision of cannabis for medical purposes, including any action against an organization providing cannabis for medical purposes in which those individuals either owned shares of stock or served as executives, and which resulted in a conviction, guilty plea, or plea of nolo contendere, or an admission of sufficient facts;

6.2.i.6. Evidence of any civil or administrative action under the laws of the state or any other state, the United States or a military, territorial, or tribal authority relating to a principal, operator, financial backer, or employee of the applicant's profession, or occupation or fraudulent practices, including fraudulent billing practices;

6.2.i.7. Evidence of any attempt by the applicant to obtain a registration, license, permit, or other authorization to operate a medical cannabis organization in any jurisdiction by fraud, misrepresentation, or the submission of false information; and

6.2.i.8. A statement that the applicant must provide evidence of workers' compensation insurance if the applicant is issued a permit and the facility is determined to be operational by the bureau.

6.2.j. A description of the duties, responsibilities, and roles of each principal, operator, financial backer, and employee;

6.2.k. A timetable outlining the steps the applicant will take to become operational;

6.2.l. A summary of the intended plan of operation that describes, at a minimum, how the applicant's proposed business operations will comply with the Act and these rules relating to:

6.2.l.1. Security;

6.2.l.2. Employee qualifications and training;

6.2.l.3. Transportation of medical cannabis;

6.2.l.4. Storage of medical cannabis;

6.2.l.5. Labeling of medical cannabis;

6.2.l.6. Inventory management;

6.2.l.7. With respect to a grower/processor's facility, nutrient practice;

6.2.l.8. With respect to a grower/processor's facility, quality control and testing of medical cannabis for potential contamination;

6.2.l.9. Recordkeeping;

6.2.l.10. Preventing unlawful diversion of medical cannabis; and

6.2.l.11. With respect to a grower/processor's facility, growing of medical cannabis, including a detailed summary of policies and procedures for its growth.

6.2.m. The relevant financial information in section 25 (capital requirements);

6.2.n. Statements that:

6.2.n.1. The applicant and each principal, operator, financial backer, and employee are of good moral character;

6.2.n.2. The applicant possesses the ability to obtain in an expeditious manner the right to use the proposed site and facility, including equipment, to properly perform the activity described in the initial permit application;

6.2.n.3. The applicant can continuously maintain effective security, surveillance, and accounting control measures to prevent diversion, abuse, and other illegal conduct regarding medical cannabis plants and medical cannabis; and

6.2.n.4. The applicant can continuously comply with all applicable laws of the state, the Act, these rules, and the terms and conditions of the initial permit;

6.2.o. The applicant must provide the bureau with releases sufficient to obtain information from a governmental agency, financial institutions, an employer, or any other person. Failure to provide these releases will result in the rejection of the initial permit application; and

6.2.p. Other information required by the bureau.

6.3. If the bureau determines that an initial permit application is complete but lacking sufficient information upon which to make a determination, the bureau will notify the applicant in writing of the factors that require additional information and documentation. An applicant has 30 days from the mailing date of the notice to provide the requested information and documentation to the bureau. An applicant's failure to provide the requested information to the bureau by the deadline may be grounds for denial of the issuance of a permit.

6.4. At the discretion of the bureau, the bureau may extend the deadline in subsection 6.3 for up to an additional 15 days.

6.5. The bureau may conduct an inspection to determine the appropriateness of a proposed site and facility, the applicant's operational status, the applicant's compliance with the laws and rules of the state, the municipality's zoning requirements relating to the applicant's proposed site and facility, if applicable, and its use as outlined in the permit application. The bureau may do the following:

6.5.a. Interview principals, operators, financial backers, and employees, including physicians and pharmacists, engaged and to be engaged in the applicant's operations for the purpose of verifying the information contained in the initial permit application.

6.5.b. Inspect transport vehicles that are or will be utilized in the transportation of medical cannabis to a facility or a laboratory.

W. Va. Code R. § 64-109-6