N.J. Admin. Code § 17:30A-7A.4

Current through Register Vol. 56, No. 23, December 2, 2024

Section 17:30A-7A.4 - Clinical registrant permit application

(a) An applicant for a clinical registrant permit shall submit a complete, separate application, on forms prescribed by the Commission, for each physical address and premises at which a permit applicant seeks to operate.

(b) A clinical registrant permit applicant shall disclose and submit, as part of the permit application process, the following materials for the Commission's evaluation:

1. The Federal and State tax identification numbers for the permit applicant;

2. Documentation of a valid Business Registration Certificate on file with the Division of Revenue and Enterprise Services in the Department of the Treasury;

3. Information about the permit applicant, including its legal name, and any registered alternate name;

4. A copy of the documents reflecting the formation of the permit applicant entity, including, but not limited to, articles of incorporation or organization, charter, bylaws, stock issuance records, operating agreements, partnership agreements, other formation documents filed with the Secretary of State, and any other documents that govern the legal and ownership structure of the entity;

5. If applicable, documents from the Federal or State government recognizing the permit applicant entity's nonprofit status;

6. A description of the proposed location and its surrounding area, including the following:

i. The mailing and physical address of the permit applicant's proposed location;

ii. A description of the suitability or advantages of the proposed location; and

iii. A site plan of the proposed location, including a floor plan, which may optionally include renderings, architectural plans, or engineering plans;

7. Evidence of compliance with local codes and ordinances.

i. Zoning approval, which shall consist of a letter or affidavit from appropriate officials of the municipality stating that the location will conform to municipal zoning requirements allowing for activities related to the operations of the proposed clinical registrant permit, and any variances granted concerning the operation of the clinical registrant;

8. Proof of local support, which shall be demonstrated by a resolution adopted by the municipality's legislative body, or by a written letter of support from the municipality's executive;

9. Documentation demonstrating that the permit applicant will have final control of the premises upon approval of the application. Documentation includes, but is not limited to, a lease agreement, contract for sale, title, deed, or similar documentation. Where a permit applicant will lease the premises, the lease shall include a provision acknowledging that the tenant's use of the premises will involve medical cannabis-related activities associated with operations as a clinical registrant;

10. The plan by which the permit applicant intends to obtain appropriate liability insurance coverage for the proposed alternative treatment center;

11. Evidence supporting any of the following bonus point categories, as applicable:

i. Permit applicants that are party to a collective bargaining agreement with a bona fide labor organization that currently represents, or is actively seeking to represent, cannabis workers in New Jersey;

ii. Permit applicants that are party to a collective bargaining agreement with a bona fide labor organization that currently represents cannabis workers in another state;

iii. Permit applicants that submit< >a signed project labor agreement with a bona fide building trades labor organization for the construction or retrofit of the facilities associated with the permit applicant;

iv. Permit applicants that submit a signed project labor agreement with a bona fide labor organization for any other applicable project associated with the permit applicant; or

v. Permit applicants that include at least one owner lawfully residing in New Jersey for at least two years as of the date of the application;

12. A clinical registrant operating plan, including a cultivation, manufacturing, or dispensing operating plan pursuant to N.J.S.A. 24:6I-7.2.c(1), (2), and (3);

13. A business and financial plan;

14. An environmental impact plan, which shall, at a minimum, include consideration of sustainable alternatives to single-use plastic packaging, efforts to minimize water usage, and any other factor required by the Commission in its notice of application acceptance;

15. A safety and security plan that conforms with N.J.A.C. 17:30A-9.7;

16. A community impact or social responsibility plan;

17. A workforce development, job creation, and diversity plan;

18. Standard operating procedures for:

i. Adverse event reporting;

ii. Quality assurance and quality control;

iii. Recall of medical cannabis items, as needed, or directed;

iv. Packaging and labeling;

v. Inventory control, storage, and diversion prevention;

vi. Recordkeeping;

vii. Waste disposal/sanitation;

viii. Cultivation, manufacturing, dispensing, delivery, and secure transport, as applicable;

ix. Accounting and tax compliance; and

x. The reporting of test results, as applicable;

19. An attestation signed by a bona fide labor organization stating that the permit applicant has entered into a labor peace agreement with a bona fide labor organization;

20. If the permit applicant opts to include in its governance structure the involvement of a school of medicine or osteopathic medicine licensed and accredited in the United States, or a general acute care hospital, ambulatory care facility, adult day care services program, or pharmacy licensed in New Jersey, the permit applicant shall demonstrate that involvement, provided that:

i. The school, hospital, facility, or pharmacy has conducted or participated in research approved by an institutional review board related to cannabis involving the use of human subjects, except in the case of an accredited school of medicine or osteopathic medicine that is located and licensed in New Jersey;

ii. The school, hospital, facility, or pharmacy holds at least a 10 percent profit share or ownership interest in the permit applicant, except in the case of an accredited school of medicine or osteopathic medicine that is located and licensed in New Jersey; and

iii. The school, hospital, facility, or pharmacy participates in major decision-making activities within the permit applicant, which may be demonstrated by representation on the board of directors of the permit applicant;

21. If the permit applicant optionally has a medical board, the by-laws, and a list of names of the members of the permit applicant's medical board;

22. If a permit applicant intends to enter into, or has entered into, a partnership with a re-entry program for the purpose of identifying and promoting employment opportunities for currently or formerly incarcerated people at the alternative treatment center, the details of such partnership, including:

i. The name of the re-entry program;

ii. The employment or training opportunities at the permit applicant's alternative treatment center that will be made available to the re-entry population;

iii. Any other initiatives the permit applicant will undertake to provide support and assistance to the re-entry population; and

iv. The training and support offered or provided for the advancement of the re-entry population;

23. An affidavit that the statements included in the application are true and correct, sworn by the permit applicant's representative;

24. An authorization to release all information pertaining to the permit applicant, as requested by the Commission, signed by the permit applicant's representative;

25. A waiver of liability for any damages to the permit holder as a result of any disclosure or publication in any manner, other than a willfully unlawful disclosure or publication, of any information acquired during the permitting process, signed by the permit applicant's representative;

26. A copy of a written research contract between the clinical registrant and an academic medical center that meets the requirements at N.J.A.C. 17:30A-7A.2.

i. A clinical registrant permit applicant may only contract with one academic medical center;

27. Written documentation from the academic medical center that it meets the requirements at N.J.A.C. 17:30A-7A.1(a), including:

i. A demonstration of current accreditations, as applicable;

ii. A declaration stating that the academic medical center has the ability to conduct medical cannabis research;

iii. The State and Federal tax identification numbers of the academic medical center; and

iv. For a school of osteopathic medicine, an articulation agreement or similar memorandum of understanding, an apprenticeship program agreement with a partner State college or university, and institutional review board approval information;

28. For a clinical registrant, in its initial and renewal application:

i. A list of the approved research programs or research studies that are continuing or, if any of them are concluded, the dates they were concluded;

ii. A report of the current status of active research programs or research studies being conducted under the research contract, including preliminary findings, if applicable; and

iii. A description of proposed research programs or research studies covered by the research contract that the clinical registrant intends to conduct within the next year following submission of the renewal application, including any institutional review board approval for the proposed research program or research study; and

29. Any other information the Commission deems relevant in determining whether to grant a permit to the applicant.

(c) The medical cannabis permit application shall additionally include a certification that the proposed medical cannabis dispensary location is not in or upon any premises that operates a grocery store, delicatessen, indoor food market, or other store engaging in retail sales of food; or any premises that operates a store that engages in licensed retail sales of alcoholic beverages, as defined at N.J.S.A. 33:1-1.b.

(d) A clinical registrant permit applicant shall disclose and submit, as part of the permit application, the following submissions relating to its qualification for a permit, pursuant to N.J.A.C. 17:30A-7A.5:

1. Organizational charts of the applicant identifying ownership, control, and operational structure, including owners, principals, management services contractors, managers, as well as all parent companies, subsidiaries, affiliates, predecessors, and successors of the permit applicant;

2. A list of all persons who are owners, passive investors, principals, and managers of the permit applicant, including their names, addresses, dates of birth, and each owner's and passive investor's percentage of ownership interest;

3. For all persons who are owners or principals of the permit applicant, a copy of their unexpired driver's license or other photo identification issued by the State, another state, or the Federal government, which shall be proof that the person is at least 21 years of age. For any person(s) directing or implementing the research study, a copy of their professional license, and/or medical license;

4. For all persons who are owners and principals of the permit applicant, a completed Personal History Disclosure Form, including a resume;

5. A list of the persons who are owners of the permit applicant who have resided in this State for at least two years as of the date of the application and documentation of such residency;

6. For each owner, principal, or employee of a permit applicant, as well as for each staff member of a permit applicant's management services contractor that participates in the obtaining, possession, securing, cultivating, manufacturing, transporting, selling, delivering, or destroying of medical cannabis items, proof that the person has been fingerprinted and written consent to undergo a criminal history record background check pursuant to N.J.A.C. 17:30A-7A.6;

7. For any person seeking to become an owner, principal, or employee of a permit applicant who has a disqualifying conviction pursuant to N.J.A.C. 17:30A-7A.6(d), evidence of rehabilitation pursuant to N.J.A.C. 17:30A-7A.6(e), if any;

8. For any person seeking to become a staff member of a permit applicant's management services contractor that participates in the obtaining, possession, securing, cultivating, manufacturing, transporting, selling, delivering, or destroying of medical cannabis items who has a disqualifying conviction pursuant to N.J.A.C. 17:30A-7A.6(d), evidence of rehabilitation pursuant to N.J.A.C. 17:30A-7A.6(e), if any;

9. For the permit applicant and each of its owners, principals, or managers, a list of any pending or adjudicated criminal charges or convictions;

10. A list of entities that are owners, passive investors, principals, and management services contractors of the permit applicant, including their names, addresses, and each owner's and passive investor's percentage of ownership interest;

11. For each entity that is an owner, principal, or management services contractor of a permit applicant, a completed Entity Disclosure Form;

12. For all persons or entities that hold at least 10 percent aggregate ownership interest in, or are a member of the executive team of, a management services contractor of a permit applicant, their names, addresses, dates of birth, positions held, percentage of ownership interest in the management services contractor entity, and a completed Personal History Disclosure Form for each person.

i. Except that for a person or entity holding ownership interest in or control over a management services contractor that is a qualified institutional investor, a completed Personal History Disclosure Form for each person is not required;

13. Any management services agreement;

14. A list that describes, beginning with the formation of the permit applicant entity, any and all sales, mergers, business combinations, and consolidations involving the entity, including any such events that occurred under a former name of the entity;

15. A list of all financial sources, including qualified institutional investors, holding debt of the permit applicant.

i. The nature, type, terms, covenants, and priorities of all outstanding debts of the permit applicant, including, but not limited to, bonds, loans, mortgages, trust deeds, debentures, lines of credit, notes issued or executed, or to be issued or executed, or other forms of indebtedness of the permit applicant or on its behalf;

ii. A completed Entity Disclosure Form for each financial source, except a qualified institutional investor; and

iii. A completed Personal History Disclosure Form for each financial source that is a person;

16. Any proposed or executed contract, term sheet, agreement, or side letter between an owner, principal, or financial source and another party that relates to the ownership and control structure, assets, liabilities, real or intellectual property, revenue, funding or capitalization, royalties, or profit, or future profit, of the permit applicant or comparable documents that change the legal structure of the permit applicant, including any financial source agreement;

17. A list of all vendor-contractors with whom the permit applicant has contracts or agreements;

18. For the permit applicant and each of its owners, principals, managers, management services companies, parent companies, subsidiaries, affiliates, predecessors, or successors:

i. A list of any currently held or previously held authorizations to participate in the cultivation, manufacturing, sale, or distribution of medical cannabis or personal-use cannabis in any jurisdiction, including a foreign jurisdiction, where the person or entity serves or served as an owner, principal, or employee for six or more months;

19. For the permit applicant and each of its parent companies, subsidiaries, affiliates, predecessors, or successors:

i. A list of any previous violation of, or judgment, order, consent decree, consent order, sanction, or penalty pertaining to any state or Federal statute, rule, regulation, or code; and

ii. A list of all pending litigation or past litigation that concluded in the last five years, whether in the State of New Jersey or in another jurisdiction, in which the entity was involved;

20. A list of every financial institution at which the permit applicant has had an account in the last five years;

21. A list of bankruptcy or insolvency proceedings by the permit applicant, and each of its parent companies, subsidiaries, affiliates, predecessors, or successors, and a copy of any bankruptcy decree as a result of the same;

22. A list of any charitable contributions made by the permit applicant in the last five years;

23. A list of stocks held by the permit applicant;

24. For each owner, principal, management services contractor, and employee of the permit applicant, certification confirming the person's or entity's submission to the jurisdiction of the courts of the State of New Jersey and agreeing to comply with all laws and rules of the State of New Jersey pertaining to medical cannabis;

25. An affirmation that the permit applicant exercised reasonable care to confirm its submission information and the ability of each person or entity in its submission to serve as an owner or principal;

26. Any other application requirement established by the Commission in a notice of application acceptance issued pursuant to N.J.A.C. 17:30A-7A.3(b);

27. Documentation that the clinical registrant applicant has a minimum of $ 15 million in capital; and

28. An affidavit from the clinical registrant disclosing any payments to its partner academic medical center made by the clinical registrant or any of its owners, passive investors, principals, management services contractors, financial sources, or employees, up to and including the date of the submission of the application, including the amount and purpose of each payment made.

(e) A clinical registrant permit applicant shall provide the Commission with a complete disclosure pursuant to (d) above that includes all true parties of interest.

1. The permit applicant or permit holder shall not attempt to conceal or disguise ownership or other control over its operations in its submissions.

(f) Application materials submitted to the Commission pursuant to N.J.S.A. 24:6I-7.3 or this section shall not be considered public record pursuant to N.J.S.A. 47:1A-1 et seq., or the common law concerning access to government records.

1. This includes a clinical registrant's or an academic medical center's research contract and research study description, patient information, and intellectual property.

N.J. Admin. Code § 17:30A-7A.4

Adopted by 56 N.J.R. 1728(b), effective 8/19/2024