question response - the official web site for the state of ......use of medical marijuana act,...

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Question Response There are two Measure 4’s for Criterion 1. Criterion 1, Measure 4 (what should be 5): Financial Suitability and Sustainability, Point 3 of the RFA requests, “Certified financial statements (audited or reviewed) in accordance with applicable standards by an independent Certified Public Accountant, which include a balance sheet, income statement, and statement of cash flow, and all applicable notes for the most recent calendar or fiscal year.” For what business or from what individuals are financial statements required? The prompt is unclear. It is within the discretion of the applicant in how best to respond to this measure. Please refer to the information provided at the pre-application conference for further clarification on the type of financial information the Department is looking for. For new entities, the applicant may consider submitting financial statements from related entities or individuals involved in the funding of the proposed new entity.

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Page 1: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Question Response

There are two Measure 4’s for Criterion 1. Criterion 1, Measure 4 (what

should be 5): Financial Suitability and Sustainability, Point 3 of the RFA

requests, “Certified financial statements (audited or reviewed) in

accordance with applicable standards by an independent Certified Public

Accountant, which include a balance sheet, income statement, and

statement of cash flow, and all applicable notes for the most recent

calendar or fiscal year.” For what business or from what individuals are

financial statements required? The prompt is unclear.

It is within the discretion of the applicant in how best to

respond to this measure. Please refer to the information

provided at the pre-application conference for further

clarification on the type of financial information the

Department is looking for. For new entities, the

applicant may consider submitting financial statements

from related entities or individuals involved in the

funding of the proposed new entity.

Page 2: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Will the Department consider extraction methodology when scoring

Criterion 1, Measure 4: Detailed summary of practices, policies and

procedures for manufacturing medicinal marijuana products? Will there

be any points awarded for using a specific extraction methodology (e.g.,

hydrocarbon, ethanol, or CO2)?

The points awarded for an application will be consistent

with Criterion 1, Measure 4 set forth in the application.

Section III of the RFA states that “Individuals and entities with a 25% stake

(in the form of debt, equity, or other financial relationship) in any of the

currently permitted ATCs, or entities responsible for the management of

currently permitted ATCs” are ineligible to apply. a. What constitutes a

25% stake in the currently permitted ATCs given that they are non-profit

corporations? b. Is a trustee or officer of a currently permitted ATC

precluded from being a principal, investor, director or officer of an

applicant? c. If so, will the DOH accept an application in which the trustee

or officer of a currently permitted ATC agrees to fully divest his or herself

of a his or her relationship with the currently permitted ATC, contingent

upon the applicant being chosen to proceed in the permitting process?  

As the potential applicant notes, 25% means any

individual or entity that maintains debt, equity, financial

relationship or any other interest of an existing ATC that

equals or exceeds 25%. Board members, trustees, and

officers of non-profits would be considered to have an

interest in that non-profit. Regarding the last question,

contingent divestment of a relationship with an existing

ATC will not be accepted by the Department.

Page 3: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

On question 20 in DMM-01A, how should public companies response? It

would not be possible to provide a list of all current shareholders.

Please refer to the information given at the pre-

application conference regarding publicly traded

companies.

What counts as a daycare or school ?  Gymboree / Math learning center? 

Zoning laws are at the municipal level and not within the

Department's purview. You must consult with the

municipality in which you wish to locate. Additionally

the applicant should take into consideration the Federal

Drug Free School Zones Act, 21 U.S.C. 860, and the New

Jersey Drug Free School Zone Law, N.J.S.A. 2C:35-7 when

determining the location for a proposed ATC. Please also

refer to N.J.A.C. 8:64-7.1.

Page 4: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Does the Department have back-up procedures in place in the event the

electronic submission system is unavailable or if an applicant receives

“errors” when submitting?

The applicant is required to comply with the hard copy

submission procedures as described at the pre-

application conference. All applications must be

received at the Department by 5:00 PM EST on August

31, 2018.

Are their any state requirements or stances on the following: Foliar

Pesticide List, Solvent list, Algaecides, Bactericides, Systemic insecticides

list, Storage requirements, Energy restrictions, Green use discounts, LED

lighting discounts, Solar/alternative energy discounts, Recycling discounts,

Equipment restrictions, Extraction room safety requirements, Laboratory

safety requirements

Applicants are encouraged to review the Compassionate

Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq.,

and the Department of Health’s Medicinal Marijuana

Rules, N.J.A.C. 8:64-1.1 et seq. Specifically, the applicant

should review Subchapter 9 (Alternative Treatment

Center General Administrative Requirements for

Organization and Recordkeeping), and Subchapter 10

(Plant Cultivation Authorized Conduct). The Act and the

Rules are on the Department of Health’s Medicinal

Marijuana website. For pesticides, refer to the EPA's

FIFRA 25(b) list of minimum risk active and inert

ingredients.

Page 5: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Is an applicant required to disclose a criminal violation on his or her

Personal History Disclosure that was expunged by judicial order?

If your criminal conviction was expunged by a court of

competent jurisdiction, then disclosure of the conviction

is not required. If you have questions regarding an

expungement, you should consult an attorney.

Are there any limitations/exclusions on extraction methodologies that be

used, e.g.: Co2 extraction, Hydrocarbon/Liquefied Petroleum Gas (“LPG”)

Solvent Based Technology namely n-butane, propane, and heptane,

Ethanol Extraction?

There are no limitations or exclusions on extraction

methodologies set forth in the current rules.

Page 6: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

The Personal History Disclosure Form 2 (“PHD-2”) includes a section

captioned CIVIL, CRIMINAL AND INVESTIGATORY PROCEEDINGS (pages 14-

15). Does Question 14 in PHD-2 require the disclosure of motor vehicle

violations or offenses?

No.

RE: RFA “Measure 4: Financial Stability and Sustainability,” the first bullet

asks for a “brief summary. . . . of the applicant’s business plan . . . “ Please

clarify as to whether this requirement is seeking a financial forecast as to

future business expenses and revenues.

It is within the discretion of the applicant how best to

demonstrate its ability to financially support the

business.

Page 7: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

RE: RFA “Measure 4: Financial Stability and Sustainability,” the third bullet

point references “[c]ertified financial statement (audited or reviewed) . . .

“ Please clarify as to what specific entities are required to produce a

certified financial statement. Is this directed to the entities that will

actually be involved in the medical marijuana business? If so, what if the

relevant entities proposed to be involved in the cultivation and dispensing

are newly formed entities with no prior business activities? Alternatively,

is the question directed to those entities involved in the funding of the

applicant’s proposed ATC?

It is within the discretion of the applicant in how best to

respond to this measure. Please refer to the information

provided at the pre-application conference for further

clarification on the type of financial information the

Department is looking for. For new entities, the

applicant may consider submitting financial statements

from related entities or individuals involved in the

funding of the proposed new entity.

What is meant by processing in Criterion 1 Measure 2.1e? Is it processing

specific to dried plant material, or does it also include processing related

to product manufacture (e.g., extraction)?

In this measure, processing includes both dried plant

material and extraction.

Page 8: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Do the Certified Financials need to be prepared by an accountant licensed

in New Jersey?No.

Does the community benefit plan provide a higher amount of points if the

location is in an urban or economically disadvantaged community?

The points awarded for an application will be consistent

with the scoring criteria set forth in the application.

Page 9: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

How would a public or a large private ownership group fulfill Section 20 of

Permit Application Part A which requires information for “all owners,

principals, partners, investors, members, board members, directors,

trustees and Officers of the ATC Entity”?

An applicant should provide a list of all persons or

business entities having 5% or more ownership in the

ATC (including publicly traded companies), whether

direct or indirect and whether the interest is in profits,

land or building, including owners of any business entity

that owns all or part of the land or building.

What exactly does verification of approval mean in Section 14 of Permit

Application Part A?

Please refer to the instructions given at the Pre-

Application Conference.

Page 10: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

What sort of evidence is the state looking for in its commitment to

research? That is at the discretion of the applicant.

Section 16 requires the ATC’s external design to be compatible with the

surrounding commercial structures.  As this is part of the mandatory

information, if the applicant fails to show compatibility their application

may be automatically disqualified.  How will the Department determine

compatibility for purposes of this criteria?  

This will be evaluated consistent with the direction in the

application. It is within the discretion of the applicant

how best to respond to this question.

Page 11: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Section 17a asks if the applicant or any owner, partner, manager, etc. has

ever applied for a license to cultivate, process, or distribute marijuana in

any jurisdiction. If an owner, partner, manager, etc. was affiliated with an

entity that has applied before a license does that entity need to be listed? 

Should applicants include both successful and unsuccessful applications in

the table in section 17b?

As set forth in the application, any applicant or any

owner, principal, partner, investor, member, board

member, director, trustee, officer, employee, parent,

subsidiary, affiliate, predecessor, successor, or related

entity who has ever applied for and/or received a license,

permit, or other authorization to participate in the

cultivation, processing, sale or distribution, etc. of

marijuana in any jurisdiction must be disclosed.

Section 8:64-11.6 (a) states that ‘An alternative treatment center is

authorized to possess two ounces of usable marijuana per registered

qualifying patient plus an additional supply, not to exceed the amount

needed to enable the alternative treatment center to meet the demand of

newly registered qualifying patients, consistent with actual demand ratios

calculated pursuant to N.J.A.C. 8:64-9.3(a)3, 4 and 5” – Does this 2 ounce

limit apply to the ATC’s Dispensary location, the Cultivation and Processing

location, or the entire operation as a whole?

The limit applies to the entire operation.

Page 12: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Our group chose locations for ATC's that currently do NOT have an ATC in

the town or adjacent areas. If a current ATC is attempting to expand into

one of these areas, will that negatively impact our application in terms of

locations we choose and secured? If so, will we be made aware of

potential expansion locations of current ATC's? 

Expansion plans that include government action are

public records and the applicant may pursue appropriate

means to obtain this information, including contact with

the target municipalities.

Does a women/ minority owned entity need to have a government-

approved certification or be a listed organization such as a Women's SBA?No.

Page 13: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

What are the minimums and maximum amount of square footage that N.J.

is looking for in a facility?There are no minimums or maximums.

What exactly is meant by market diversification? Is the state looking for

additional product lines or forms of medical cannabis? Or is the state

looking for more diversity among producers? If looking for more diverse

producers, does this bar existing out of state producers

from applying? If not barred, are existing producers or associates or

employees of existing producers allowed to enter into joint ventures to

seek a new license?

The Department is seeking diversity in all aspects of the

operation, including but not limited to products,

producers, and location. There is no residency

requirement for applicants. Refer to pre-application

conference materials for additional information.

Page 14: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Part A, Question 30 Criminal History - is this question restricted to the past

10 year period or is asking for disclosure of charges that occurred at any

point in time?

No, the question refers to any and all criminal charges

regardless of timeframe.

Part B, Measure 1 - Since most applicants are new entities, can they use

the prior experience of their owners to answer these questions?

It is within the discretion of the applicant how best to

respond.

Page 15: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Is pay compensation question # 20 part b of application. the pay

they get for working for this company only? 

Compensation includes any pay received in relation to its

work for the ATC entity.

Are there limitations on lights, plant count (clone, vegetation, flowering)

or square footage?No.

Page 16: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Are there guidelines for integrated pest management (IPM)? No.

Additionally, in a larger building that is subdivided with different distinct

sections; can multiple ATC Applicants apply using the different

addresses/subsections?

Two applicants may apply with the same address.

Page 17: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Can the Department clarify what requirements from N.J.A.C. 8:64-10.7

remain for applicants in light of P.L. 2013, c. 160

By operation of the legislation, N.J.A.C. 8:64-10.7(a) no

longer applies.

Section 4.1(f) of the application requests plans to manage cannabis pests

without application of pesticides. This question mirrors the current New

Jersey medical cannabis rules that do not allow any pesticides to be

applied to cannabis crops. Does this exclude the use of OMRI approved

products such as Suffoil-X (the active ingredient is mineral oil), beneficial

bacterias such as beuvaria bassiana (found in Mycotrol by Bioworks) and

similar products? Does this preclude the use of beneficial insects to

control pests?

For pesticides, please refer to the Environmental

Protection Agency's FIFRA 25(b) eligible active and inert

ingredients lists. The only products allowed to be used

are those that meet the "minimum risk" criteria under

FIFRA 25(b). Beneficial insects, and similar means, are

permitted.

Page 18: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Is there a list of banned additives, either for insecticide or nutrient

purposes? If there is an approved list of additives where can that be

found?

For pesticides, please refer to the Environmental

Protection Agency's FIFRA 25(b) eligible active and inert

ingredients lists. The only products allowed to be used

are those that meet the "minimum risk" criteria under

FIFRA 25(b).

What is the definition of a pesticide? Are natural or biological pest control

measures permitted?

For pesticides, please refer to the Environmental

Protection Agency's FIFRA 25(b) eligible active and inert

ingredients lists. The only products allowed to be used

are those that meet the "minimum risk" criteria under

FIFRA 25(b). Beneficial insects, and similar means, are

permitted.

Page 19: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Will branding be allowed in the application materials? That is, the

branding will be prominently displayed on the building, packaging and

drawings. Is the State okay with this being included in our application?

This is within the discretion of the applicant.

Criterion 1, Measure 5a, Does the five page limit include the financial

package (developed budget, projected expenses, and revenues)? Or is the

limit simply related to the narrative explanations of the developed tables

and financial package?

Refer to the pre-application conference materials.

Page 20: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Criterion 1, Measure 5d, Do record of business tax payments count toward

the total page limit, or are they excluded similar to floor plans and

renderings?

Refer to the pre-application conference materials.

Number 20 asks about Pay/Compensation in terms of Type, Value and

Description. Is this referring to hourly vs. salary, amount, and what is

sought regarding description?

The term Type refers to compensation package, Value

refers to worth of the compensation package and

Description refers to job title, duties and responsibilities.

Page 21: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Number 22 seeks contractors, vendors, etc.  Do you want all construction,

engineering, architects and the like or specific applying only to operation?

Question 22 refers to any and all contracts and

agreements that relate to the operation of the ATC.

What period should the financial statements cover?

The financial statements must cover the period sufficient

to demonstrate the source(s) of the income, as all

investments must be vetted.

Page 22: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Is it necessary for dispensary locations to maintain a record or patient pain

levels upon each disbursement of medical product?

No, refer to N.J.A.C. 8:64-11.4 for pain and/or primary

qualifying symptom assessment record requirements.

How does the state define measurement of THC levels? Refer to the pre-application conference materials.

Page 23: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

What does the state consider to be the equivalent dose between formats

of cannabis product?  Are dosage measurements focused on material

weight or amount of active ingredient?

A dosage unit shall have a cannabinoid concentration

that is within 95% to 105% of the specified milligram

dose for that dispensable product.

Is section 1A considered the Entity Disclosure Form?No. The Entity Disclosure Form will be provided when

and if needed.

Page 24: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Whose record of past business taxes paid to federal, state and local

governments are required to be provided if the applicant has formed a

new LLC in the state? How many years of taxes are required?

If there is no record of past business taxes paid, you

should provide information pertaining to the ATC entity's

proposed ability to comply with tax requirements. See

pre-application conference materials for additional

information.

What type of evidence should an applicant provide to show that the

proposed ATC will improve competition and diversification in the New

Jersey market? Is this determination based on whether or not the

applicant has an interest in another permitted ATC? Based on access to

underserved markets?

This is within the discretion of the applicant. The

applicant should be mindful that individuals or entities

with a 25% stake (in the form of debt, equity, or other

financial relationship/interest) in any of the currently

permitted ATCs, or entities responsible for the

management of currently permitted ATCs are ineligible

to apply.

Page 25: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

Are consultants who were hired solely to work on the Application required

to be part of the disclosure listed in Part A Section 21? No.

For Measure 7: Market Diversification Plan; please define “diversification”

in this context and how the Department will weight the available points.

The Department is seeking diversity in all aspects of the

operation, including but not limited to products,

producers, and location. Points will be awarded based

on the scoring criteria contained in the RFA.

Page 26: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

What if additional owners wish to become involved with an entity

between the time of application submission, August 31, 2018 and the date

the applications are approved, November 1, 2018?  Is there a mechanism

to add owners?  May an entity remove an owner after the application has

been submitted?

The Department will not accept amendments to the

application after the application deadline.

Are you looking for the litigation of the applicant or litigation of every

employee and advisor on the team? In other words, do we have to

disclose litigation that an employee or advisor is under which might have

no overlap in this submission process. For example, do we have to disclose

frivolous lawsuits? 

Applicants are expected to list any and all existing or past

litigation (including any arbitrations or other forms of

alternative dispute resolution) to which the ATC Entity,

or any parent, subsidiary, affiliate, predecessor,

successor, or related entity is/was a party, whether in

this state or in another jurisdiction.

Page 27: Question Response - The Official Web Site for The State of ......Use of Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq., and the Department of Health’s Medicinal Marijuana Rules,

What are To/From Dates for Questions 20, 21 and 22 on DMM-01A

representative of? Home or Business Addresses?

The To/From dates refer to the dates of association with

the ATC.

If the ATC location is not approved by a municipality, what is the approval

process with the Dept. for seeking an alternative location? Is the $20,000

relocation fee required?

If the applicant is considering alternate locations, each

location requires a separate application and fee.

Relocation fees apply only to existing ATCs.