hawaii state department of health · 2016. 7. 4. · since 2011, delta 11 inc. has operated a legal...

Owner_Principal_Member_Report (1)

OWNER / PRINCIPAL / MEMBER REPORT

Please include a signed statement by each Owner, Principal, or Member certifying that the information is complete and accurate.

Name of Owner, Principal, or Member Address (Street, City, State, Zip, Country (if not USA)) Phone Number Email Address

Percent Interest in the Company

State of Primary Residence

Number of Years Lived in Hawaii (most recent uninterrupted number of years person has been a resident)

Has person ever been convicted of a Felony? (If So, STOP, they are not an eligible applicant)

Has person ever been convicted of a crime?

If person has been convicted of a crime, please describe (e.g., conviction, date, disposition, etc.)

Has person ever been arrested?

If person has ever been arrested, please describe (e.g., date, disposition, etc.)

eCrim Report Validation Code

Denim Cretton 8 d 51% HI 39

Alessandro Boggio 44% CA 4

Gaspare Indelicato 5% CA 0

Page 1 of 1

1 Applicant – Delta 11 Hawai'i Inc. Application, Merit Criteria, Section 1: Application Ability to Operate a Business

We have the proven ability to operate a business and the requisite education, knowledge, and experi-

ence, including establishing and operating a successful vertically integrated medical marijuana opera-

tion in California since 2011. Importantly, we will donate 3% of revenues to support community-

based food security and natural resource protection projects, while creating a negative carbon foot-

print (no negative environmental impact). We will also offer significant discounts for seniors, veter-

ans, and those experiencing financial hardship, we will create hundreds of jobs, both for our Medi-

cal Marijuana operation & for our community Mea'Ai sustainability program.

A) Regulated Industries - CEO of Delta 11 Hawai'i Inc, Alessandro (Alex) Boggio, founded,

owns, and has been the CEO for the last five years of a registered California not-for-profit medical

marijuana corporation, Delta 11. Alex’s academic background is in business and finance and

founded Global Edge Solutions LLC, a software localization company, which he sold in 2004 and

then moved to the Hawai'i Island. Head of Manufacturing for Delta 11 Hawai'i Inc., is Erica Boggio

with five years experience as the CFO of Delta 11 California operations. COO and President is

Denim Cretton, born and raised in Hawai'i and has two BBA degrees, International Business and

Marketing, and a Masters degree in Education from the UH at Manoa. Denim has ten years of suc-

cessful business management and retail experience and helped pave the way for regulatory change

that is now a standard practice in the Hawai'i DOE system as the first special education teacher to

practice a full inclusionary model for his students on the Big Island. He also served as treasurer on

the asset management board for Hawai'i Academy of Arts and Sciences, which is strictly regulated

by DOE. For the last three years, Denim has been making regular trips to California to train in all

operations of the medical marijuana industry in preparation for Hawai’i dispensaries. Clarence Ba-

ber is Head of Horticulture and co-founded the Hawai'i Organic Farmers Association, a certifying

body that regulated organic farming in Hawai'i until recently and is a charter member of the Hawai‘i


Agricultural Hemp Cooperative and Co-coordinated Hawai'i Farmers Union United’s statewide ef-

fort to pass legislation in support of industrial hemp. Clarence studied civil engineering at Old Do-

minion University and moved to Hawai'i 38 years ago.

B) Agriculture or horticulture - Clarence Baber, Head of our Horticultural Division, has been

farming in Hawai'i for 36 years. He is a founding charter member of the Hawai'i Herb Association

and co-founded the Hawai'i Organic Farmers Association (HOFA). Cab has run large production

scale grows of various agricultural crops, including owning and operating the largest organic tomato

operation in the state and is a consultant to other farmers. Dr. Jana Bogs heads Delta 11’s Mea ‘Ai

Sustainability Program, is a nutritionist and horticulturist, and CSO (Chief Science Officer) for the

Nutrition Grown Farming Center. Thomas J Motzko is the Director of Medical Marijuana Cultiva-

tion for the California operations of Delta 11 Inc. and is the Lead Cultivation Grower for Delta 11

Hawai'i Inc. Josiah Hunt is the founder of Pacific Biochar, a soil consultant, and UH Hilo Gradu-

ate with a BS in Agroecology and Environmental Quality.

C) Commercial manufacturing - Alex Boggio, our CEO , has five years experience overseeing all

production of medical marijuana products for Delta 11 Inc. in California. Erica Boggio is head of

our Hawai'i manufacturing and, as CFO of Delta 11 Inc. California operations, she helped develop

commercial manufacturing processes and a line of medical marijuana products. Clarence Baber,

Head of Horticulture was the first commercial manufacturer of EM Bokashi (microorganism prod-

uct) on Hawai'i Island, beginning production in1998 and produces a line of proprietary agricultural

mineral mixes and feedants. Josiah Hunt, founder of Pacific Biochar, has built his commercial man-

ufacturing plants in both Hawai'i and California. He is also recognized for his success with commer-

cial scale organic papaya cultivation.

D) Pharmaceutical companies - Delta 11 Hawai'i Inc. has consulted with a pharmacist regarding


patient confidentiality and medical dispensing protocols. Please see Delta 11 Hawai'i Inc. Employee

manual regarding the handling of medical records and HIPPA compliancy.

E) Operating or working in a medical marijuana dispensary business -

Since 2011, Delta 11 Inc. has operated a legal and fiscally responsible medical marijuana nonprofit

corporation in Marin County, California, providing controlled access to medical marijuana for quali-

fied patients. Delta 11 Inc. maintains the highest levels of quality control of medical marijuana, all

product are HPLC tested as required in Hawai'i. We also use a mass spectrometer to ensure our

medical marijuana is free of mold, mildew, and pollutants. Additionally, all products are labeled with

active medical and other ingredients. We have contracted with BioTrackTHC system to track all

product and receipts, banking drops will be made daily and all safety and security measures are in

place. We have never had a security issue in five years of operation at any of our business unit loca-

tions (grow & production sites, or dispensary) due to our state-of-the art 24/7 camera and security

systems. We will carry special medical marijuana business insurance for its business premises and

maintain its Employment Development Department insurance. Staff will be paid via pay roll and all

applicable pay roll taxes paid. We will provide full medical insurance for employees.

F) Creating and implementing a business plan - We have based our business plan on the suc-

cessful model implemented and currently used by our CEO in California. Our business plan is at-

tached, it meets the specific needs of Hawai'i Island. We have developed a targeted growth model,

designed to produce medical marijuana in a discreet and sustainable manner. We will setup our grow

& production centers in strategically designed phases. The community wants a secure, and discreet

grow & production center out of public access or view. We have one chance to gain confidence, a

large scale medical marijuana production center will cause community concern on Hawai'i Island.

Our experience allows us to launch a vertically integrated medical Marijuana business, using evidence


based approaches and training techniques needed for business development and success.

G) Creating and implementing a financial plan - We have developed a detailed five year pro

forma based on the successful setup and operation of a vertically integrated, community sensitive,

medical marijuana operation in California. Details of which can all be found in our business plan

included with this application, or directly in attached excel 5 year Pro Forma.

H) Retail sales - COO and President Denim Cretton has over ten years experience in retail man-

agement and sales. His experience includes inventory management, employee management, staffing,

creating standards of practice, training, reconciliation, sales, and customer service.

I) Secure inventory tracking and control - Currently Delta 11 Inc. has implemented and is cur-

rently using a seed to sale inventory and point of sale system that tracks all activity of Marijuana.

Delta 11 Hawai'i Inc. has already contracted with BioTrackTHC since it was the system chosen by

Hawai'i DOH and will be implementing this system.

J) Protecting confidential customer information - Delta 11 Hawai'i Inc. Employee Manual out-

lines protocols for safeguarding Protected Health Information (PHI) of customers and HIPPA com-

pliance. All Delta 11 data centers and databases are secure, encrypted, and risk-assessed on a regular

basis and our Hawai'i operation will use HIPAA certified data management centers. Our CEO has

five years experience implementing best practices to ensure HIPPA compliance at his California dis-

pensary he will bring this expertise to Hawai'i.

K) Owning or managing a business that required twenty four hour security monitoring -


Richard Page, Head of Security Delta 11 Inc., is a systems security specialist Richard designed, in-

stalled, and oversees the 24 hour security monitoring for the Delta 11 California operations and will

install and oversee all aspects of security for Delta 11 Hawai'i Inc. Alex Boggio, CEO Delta 11 Inc.,

and Erica Boggio, CFO Delta 11 Inc., assisted with implementing with Delta 11s 24/7 security sys-

tem for the California grow and dispensary operations.

L) Other Expertise – Our Core operations and management teams is a diverse group of Medical

Marijuana industry experts and Island business people and local agricultural experts, scientists, and

educators. We have been working closely with community leaders, including Senator Russell Ruder-

man and Kuulei Kealoha, to ensure the most appropriate integration of our operations to the com-

munity. We are donating 3% of revenues to local agricultural and natural resource protection pro-

jects, while we ensure our carbon footprint is negative (no negative environmental impact).

1 Applicant – Delta 11 Hawai'i Inc. Application, Merit Criteria, Section 2: Plan for Dispensary

Delta 11 Hawai'i inc. is a registered Hawai'i C Corp, it will consist of 4 business units as follows:

i) Medical Cannabis Cultivation Center

We will be implementing a growth model based on projected demand to roll out of our Cultivation

Centers. Initially the demand will be relatively small however demand will increase rapidly, and even

more so once qualified visitors are able to get their medical cannabis in Hawai'i. The Delta 11

Hawai'i Inc. Cultivation team consists of experienced Medical Cannabis cultivators that are experts

in the Delta 11 Inc. methodology and cultivation system which has been developed and

implemented by our CEO in California.

Current scientific research shows that regenerative growing practices also contribute to carbon

sequestration by natural processes of photosynthetic removal and retention of atmospheric CO2 in

soil organic matter. This contrasts to typical marijuana growing operations that don’t build soil

organic matter over time, but throw away large quantities of soil after each growing cycle, while

hydroponic operations compound this waste, often losing up to 40% of the irrigation water through

a “run-to-waste” method. Our regenerative practices are a contrast to this typical waste by

sequestering carbon and emphasizing the use and production of local inputs and amendments and

continual reuse and building of our soil. Simple practices like companion planting with food herbs

creates a living mulch (saving water), increases soil fertility and soil microorganism activity, and

strengthens plant immunity reducing pest challenges. Although the environmental, social, and

human health benefits of the methods we use are significant, they are rarely fully incorporated into

marijuana productions because the initial growing expenses are higher with these practices. But, we

believe the environmental and community benefits warrant this investment.

We are able to control environmental factors to maintain ecologically friendly cultivation centers.

Our team utilizes standards of practice that ensure consistent cultivation of medical grade cannabis.


Our unique cultivation system ensures the highest quality while leading the industry safety standards

by using chemical free and pesticide free horticultural practices.

ii) Medical Cannabis Production & Quality Assurance Center

The Production & Quality Assurance Product team consists of experts in manufacturing and design

of Delta 11 Hawai'i Inc. medical cannabis based products. A wide variety of medical cannabis based

products will be available to medical patients to better suit their individual medical needs as allowed

under Hawai’i Act 241. For example, those with arthritis pain can use a topical that helps reduce

pain and swelling. For people who do not want to smoke cannabis we provide alternatives such as

capsules that can be taken instead or tinctures that can be taken orally in the form of drops. For

seizures we create a CBD rich product that has very little psychotropic effect but amazing effects for

people with seizures and Migraines.

iii) Two Medical Cannabis Retail Storefronts

Offering safe and comfortable environments for qualified Medical Cannabis patients to access high

grade medical cannabis products that are safety tested in an independent, Certified HPLC lab for

contaminants, molds and mildews and for potency, our products will always be Chemical and

Pesticide Free.

Storefronts will have all security measure needed to provide safety for customers as well as staff.

Please see business plan for security plan for Dispensary storefronts.

We will be banking several times each day via secured transport, to ensure no excess cash is ever on

site at dispensaries (this is possible regardless of federal banking restrictions) please review business

plan for details.

Education and recommendations for people who are not familiar with medical cannabis and the best

forms of the medicine based on their ailments. We will always have a Medical Cannabis Expert on


hand at each storefront who will be able to assist people. We will also make learning materials

available to all of our qualified medical cannabis patients. For more information on medical

cannabis use and chemical compositions etc please refer to addendum 4 in our Medical Cannabis

Effects Study.

Our local resident rates for medical cannabis will be heavily discounted (at a rate of 50%) so as to

discourage people from purchasing cannabis illegally on the black market. We will also have many

discount programs for the elderly, veterans and those with financial hardship.

iv) Mea ‘Ai Sustainability Program

Delta 11 Hawai'i inc. is pledging 3% of all retail sales to its Mea ‘Ai (To Eat) Sustainability Program

in partnership with the former Lt. Gov. James Kealoha Estate, as managed under the Miulan P.Y.

Kealoha Trust, under advisement of Kuulei Kealoha Cooper, Trustee.

Our Mea ‘Ai Sustainability Program is a community benefit program designed to fund land

reconstitution projects for native and edible forests, community and school gardens, Hawai'ian

fishponds and the creation of other relevant local food sources. Dr. Jana Bogs, author of Beyond

Organic, is the Head of the Mea ‘Ai Sustainability Program, and will provide educational

opportunities and guided oversight of best practices in healthy and beyond organic food.

The Kealoha Estate’s Pelekumu Lagoon Project, in partnership with the County of Hawai'i, is a

perfect start to our community funding initiatives in Puna. Together we will reconstitute the land

that was previously farmed for papayas and create a local community farm that will produce healthy

fresh fruits and vegetables for local community residents at a very reasonable rate. Community

members and educational groups will have the opportunity to grow healthy food while learning best

practices from experts in farming and cultural cultivation practitioners. During the recent lava

threats it became increasingly clear that Puna need a viable and sustainable local food source. The


Mea’Ai Sustainability Program will put funding directly into Hawaiian lands, empowering and

embracing the land management traditions of the Ahupua’a.

vi) Timeline

As a vertically integrated business model we have to ensure that all business units are working

smoothly and seamlessly together. Our CEO currently operates a vertically integrated medical

cannabis business in California and will be overseeing all operations in Hawai'i.

The first 3 business units are the generators of all revenues and will be examined below in our

operational timeline. The 4th business unit is our pledge to give back to the community and the

revenue will be immediately put into it's own account for the development of our Mea'Ai

sustainability program, this program will start in the second year of operation once we have

established sufficient funds to start the first program.

We are basing our 5 year timelines on our 5 year business Pro Forma, our timelines show the most

pertinent operational milestones:

1) Build of indoor Grow operation & Production facility - projected start: July 4th 2016

Assumptions are that we have got all our building permits within 10 weeks of application.

2) Start of Vegetative indoor grow of 1000sf per stage - projected start: August 29th 2016

Assumptions are that we have already seeded plants in mothering room starting on August 1st.

3) Start of Flowering indoor grow of 3000sf per stage - projected start: September 26th 2016

Assumption of a 4 week vegetative growth already performed in separate vegetative section.


4) Start of curing of first weekly continual harvest - projected start: November 28th 2016

Assumption of an average 9 week flowering cycle.

5) Production & packaging of retail products - projected start date: December 27th 2016

Assumption of 2 week dry period.

6) Opening of 2 Dispensary storefronts - projected start date: - January 2nd 2017

Assuming we have applied for and been given all required permits we will start the build out of the

security system and dispensary specific needs. Assumption of 2 week trim, packaging & production

of first line of concentrates and cannabis infused products permitted.


5 Year operational working timelines each segment represents 2 weeks

1

Applicant – Delta 11 Hawai'i Inc.

Application, Merit Criteria, Section 3: Financial Stability and Resources

C) Our financial plan for operating a vertically integrated medical marijuana operation in Hawai'i is

available in the attached 5 year pro forma, a more in depth overview is attached in the form of our

business plan. We have all the data relating to all fixed and variable costs associated with the setup

and operation of our grow operation, production operation and 2 dispensary storefront locations.

We know all these expenses since we have implemented the same business model in California 5

years ago and have been successfully following the proposed business plan. We have taken into ac-

count all Hawai'i specific expenses for electric costs etc.

1 Applicant – Delta 11 Hawai'i Inc. Application, Merit Criteria, Section 5: Capacity to Meet Patient Needs

Capacity to meet the needs of qualifying patients, including but not limited to:

A) Educating patients on how marijuana can be used to assist patients with debilitating medical

conditions and about the marijuana and manufactured marijuana products that will be available in

the applicant’s retail dispensing locations;

Delta 11 Hawai'i Inc. believes in community contribution, education, and outreach. Delta 11 Hawai'i

Inc. will provide training, develop community partnerships, and provide community based and indi-

vidualized educational opportunities for current and potential patients and caregivers. We offer an

individualized approach to our medical cannabis patients and caregivers. We utilize longitudinal pa-

tient data provided in seed to sale inventory tracking by BioTrackTHC to help patients and caregiv-

ers make informed decisions for their medical needs. Our staff are trained in the benefits of various

cannabis strains for specific ailments such as CBD Rich cannabis strains for migraines, seizures, anx-

iety and PTSD, whereas Indica dominant strains are a natural anti-inflammatory, blood pressure re-

ducer and most effective for sleep disorders, Sativa dominant strains will work very well for pain

management, asthma and as an appetite stimulant. Thanks to Delta 11 Inc. HPLC lab that our CEO

operates in California we are able to identify strains that are rich in very specific but less well known

active ingredients such as THC-V and THC-G.

Delta 11 Inc. is an active participant in community service projects within the local community in

California and will be a positive addition to any community in Hawai'i. Delta 11 Hawai'i Inc. contin-

ues to be actively involved in legislative and community based decisions involving holistic treatments

and medical marijuana. Delta 11 Hawai'i Inc. will actively work with local and state government and

law enforcement officers to allow for compliance and transparency as stated under Hawai'i State law.

B) Producing and maintaining a supply of marijuana that is sufficient to meet the needs of qualify-

ing patients:

Delta 11 Hawai'i Inc. will be using a proven method of continual harvest cultivation, this allows for

weekly production cycles and ensures that if we have a crop issue it will be isolated to just a week

worth of inventory. We will use nitrogen packaging sealing machines to safely store a backup inven-

tory sufficient to cover 4 months work of a grow production cycle from a grow unit. This will en-

sure that even if multiple grow units have issues we will never run low on inventory. Due to our

ability to extend our grow facility with very little time constraints, we can quickly add new grow units

on demand.


than 2 patients per retail employee. We will have a secured and comfortable waiting room as a pre-

cautionary measure.

The Retail Management team has developed standards of practice that ensures that only pre-quali-

fied medical patients are served, this includes an ID Card service as well as each dispensary member

having had their medical records verified with the doctor who has recommended their use of medi-

cal cannabis. Each doctor who has provided their patients with recommendations for Medical Can-

nabis will be verified to make sure that they have a current Hawai'i state medical license to practice

medicine and that they meet the requirements to recommend patients for medical cannabis.

D) Measuring and improving customer satisfaction:

Delta 11 Hawai'i Inc. will utilize multiple measurement of customers satisfaction. Our retail team is

trained to ask a series of intake questions designed to gather patient information that will lead to in-


dividualized treatments and service. We gather specific information from our patients utilizing pa-

tient surveys and questionnaires. We utilize patient petitions and feedback forms to present and

gather information that are valuable to our medical patients.

Delta 11 Inc. recently asked our current members in California to submit letters of recommendation

to show our customer satisfaction, within the last month or so we have collected hundreds upon

hundreds of letters of letters of support and have attached a pdf document with all letters from cur-

rent members.

We will be using BioTrackTHC which will enable us to collect, store, and retrieve all data and activ-

ity. All inventory records, patient records, recall reports, sales/transaction records, product disposal

records, and all scanned documents can be accessed at any time (real time), either in-system or

through the report creation tool. This will allow us to help our patients find the most effective med-

icines for their ailments and create customer recommendations to maximize the medicinal benefits.

1

Ability to comply with criminal background check requirements pursuant to this chapter

and sections 329D-7, 329D-12, and 846-2.7, HRS; All directors, employees, subcontractors,

and anyone otherwise associated with Delta 11 Hawaii inc. shall comply with fingerprinted

background checks prior to hiring or access of our facilities. All potential employees will be

screen and evaluated as guided by the hiring processes included in our employee hand-

book. The applicant and applying entity members have already fulfilled the fingerprinted

background check requirements.

1 Applicant – Delta 11 Hawai’i Inc. Application, Merit Criteria, Section 7: Inventory Tracking, Security, and Sales Limits

Ability to comply with the requirements in this chapter and chapters 329 and 329D, HRS, for in-

ventory tracking, security, and sales limits for qualifying patients; SUBCHAPTER 5 TRACK-

ING REQUIREMENTS§11-850-61 Tracking requirements.

a) A dispensary licensee shall track electronically the dispensary's inventory of marijuana and

manufactured marijuana products through each stage of processing, from propagation to point of

sale, disposal, or destruction, and maintain a record of clear and unbroken chain of custody at all

stages, including during transport of the inventory between dispensary facilities and between a

dispensary facility and a laboratory.

Delta 11 Hawai’i inc has contracted with BioTrackTHC maintain inventory tracking patient con-

trol systems. The BioTrackTHC system is comprised of several components; all of which are de-

signed to seamlessly integrate with one another. Recognized as the industry leader in seed-to-sale

tracking, the BioTrackTHC producer, processor and retail tracking components are completely

interoperable with one another. Whether the tracking requirements include plants, trimmings,

waste, conversion, dispensing or anything in between; the BioTrackTHC system, in concert with

its unique inventory typing system, can currently track anything the industry allows by law.

The BioTrackTHC System issues a globally unique, non-repeating 16-digit identification number

to each plant. At every stage in the product lifecycle where something needs to be differentiated,

the System issues a new “child” identifier (e.g., separating flower from stems during the harvest

process, separating edible batches that are going to different dispensaries, the creation of new

clones or seeds from a mother plant, etc...). The System issues the identifier to prevent accidental

or intentional identifier duplication by the user, and the 16-digit identifier ensure scalability and

longevity—the System could generate 1,000,000 identification numbers per second and it would

not run out of unique identifiers for over 317 years.


Every identifier is associated with a quantity that is measured in either discrete units or a weight

depending on the item’s classification; for example, plants, seeds, and infused edibles are meas-

ured in discrete units, whereas, bulk flower and stems are measured in continuous weight. This

creates an unbroken audit chain. Select any identification number and both the State and the reg-

istered organization can backwards-trace the medical cannabis product’s lineage all the way back

to the plant from which it came, and also forwards-trace every gram to where it is still in inven-

tory, where it has been dispensed, to whom it was dispensed, and where it was destroyed.

As an example, if 100 grams were harvested from plant 98765: in this case, 2 grams were con-

sumed by the testing laboratory, 8 grams were dispensed to patient Smith, 15 grams were dis-

pensed to patient Jones, 55 grams are still in inventory, and 20 grams have been destroyed. La-

boratory testing is built-in and tied directly into the inventory typing system. This allows for very

complex or very simple rules on what needs to be tested, what the testing requirements are, the

pass/fail limits, etc. This testing paradigm provides a model for ensuring that only properly tested

product may be sold to a patient. The system’s integrated features can be setup to prevent the

sale or transfer of product that has not passed state mandated laboratory tests, if necessary.


(b) A dispensary licensee shall track electronically all sales of marijuana and manufactured mari-

juana products to qualified patients and primary caregivers from all dispensaries in the State, to

ensure that no sales are authorized in excess of legal limits, as set out in section 3290-7, HRS,

and shall have a sales system that automatically prohibits sales in excess of the legal limits and

that cannot be overridden manually.

Within “Sales Limits” a BioTrackTHC user can regulate the permissible quantities allotted to a

patient or caregiver. The system stores patient purchases and cross-references with any Depart-

ment defined limits. As the system will be recording every transaction, this data can be parsed,

filtered and reported against at any time. The system can also issue stop purchase alerts if a pa-

tient attempts to exceed said defined limits and disallow the completion of such a sale.In the

event that a patient has exceeded their purchasing limit; the retail dispensing location will be no-

tified within the Tracking System that the patient has exceeded their sales limit; in response, the

System will issue a stop purchase alert. The System does not allow for a retail dispensing loca-

tion to transact with a patient that has exceeded their pre-defined sales limit.


(c) A dispensary licensee shall acquire, operate, and maintain a secure computer software track-

ing system that interfaces with the department's computer software tracking system to allow the

department real time, twenty-four hour access to the dispensary licensee's tracking system and

inventory records. The dispensary licensee's tracking system shall capture and report all the data

required by the department's tracking system.

BioTrackTHC is the winner apparent to the state contract for Hawaii’s computer software track-

ing system for the medical marijuana dispensary system based on and in compliance with Chap-

ter 329D HRS. BioTrackTHC’s commercial software provides seamless data exchange integra-

tion between a licensee and the state’s marijuana tracking system. There will be integration via

the application program interface (API) between the registered organization’s BioTrackTHC en-

terprise system and the state interface utilized by the Hawaii DOH. This will allow data to be


sent in real time, not only from the registered organization to the state, but it will allow the regis-

tered organization to retrieve transferred data by Hawaii DOH.

BioTrackTHCTM enables the business to collect, store, and retrieve all data and activity. All in-

ventory records, patient records, recall reports, sales/transaction records, product disposal rec-

ords, and all scanned documents can be accessed at any time (real time), either in-system or

through the report creation tool. Though system actions can be adjusted or voided, at no time is

any data ever fully deleted as BioTrackTHCTM maintains a log of every action, including ad-

justments and voids, so that the entire history of the system may be reconstructed. The availabil-

ity and report ability of the system data enables the said entity to produce any information neces-

sary for the Department during an inspection or at the Department’s request.(d) In the event of a

breach or failure of its tracking system, a dispensary licensee shall suspend operations dependent

on the tracking system until the tracking system is fully operable. The dispensary licensee shall

notify the department immediately upon the breach or failure, and again when it resumes opera-

tions. In the event of a loss of internet access, BioTrackTHC has the ability to operate in Offline

mode. While operating in Offline mode a facility may continue to process sales with an on-site

server, even if the internet connectivity goes down. When service is restored, all changes made in

Offline mode will be updated and synced within the system.

1 Applicant – Delta 11 Hawai’i Inc. Application, Merit Criteria, Section 8: Maintaining Patient Confidentiality

Ability to maintain confidentiality of a qualifying patient’s medical condition, health status, and

purchases of marijuana or manufactured marijuana products;§11-850-42 Allowed quantities for

dispensing.

a) A dispensary licensee may dispense to a qualifying patient or primary caregiver any combina-

tion of marijuana or manufactured marijuana products that shall not exceed four ounces of mari-

juana during a period of fifteen consecutive days, and shall not exceed eight ounces of marijuana

during a period of thirty consecutive days .

(b) Consistent with section 11-850-61, a dispensary licensee shall determine the quantity of mari-

juana or manufactured marijuana products purchased by a qualifying patient or primary caregiver

from any other licensed dispensary within the state and shall not sell any amount of marijuana or

manufactured marijuana products to that qualifying patient or primary caregiver of a qualifying

patient that exceeds the limits identified in this chapter.

Delta 11 Hawai’i Inc. has contracted with BioTrackTHC maintain inventory tracking patient

control systems. BioTrackTHC enables the business to collect, store, and retrieve all data and ac-

tivity -- with respect to inventory transfers, inventory-tracking records, supplier records, patient

records, client-records, employee records, recall reports, quarantine and waste reporting,

sales/transaction records, disposal records, and all scanned documents -- at any time, in real time,

either in-system or through the report creation tool.

Delta 11 Hawaii Inc. provides training of staff to follow HIPAA Privacy laws as outlined in our

employee handbook with consultation of a pharmacist.


Delta 11 Hawai'i Inc. is committed to providing the safe, quality controlled access to medical

cannabis and medical cannabis based products at a discounted and affordable price for our local

island residents and our senior citizens. As local residents, we understand the costs associated

with island living. We also understand that these costs get compounded by the fixed incomes of

our Kupuna. We are honored to offer both a Kama’aina Discount and a Kupuna Discount to our

Hawai'i residents. To ensure local residents do not purchase at resident price and then try to ille-

gally sell to tourists we will only allow people to purchase once per day and will cap their pur-

chasing to 4 oz every 15 days.

Within “Sales Limits” a BioTrackTHC user can regulate the permissible quantities allotted to a

patient or caregiver. The system stores patient purchases and cross-references with any Depart-

ment defined limits. As the system will be recording every transaction, this data can be parsed,

filtered and reported against at any time. The system can also issue stop purchase alerts if a pa-

tient attempts to exceed said defined limits and disallow the completion of such a sale. In the

event that a patient has exceeded their purchasing limit; the retail dispensing location will be no-

tified within the Tracking System that the patient has exceeded their sales limit; in response, the

System will issue a stop purchase alert. The System does not allow for a retail dispensing loca-

tion to transact with a patient that has exceeded their pre-defined sales limit.


Delta 11 Hawai'i Inc. offers onsite consultation with a medical cannabis specialist to best identify

needs and provide targeted medical solutions to medical cannabis patients. Our targeted and indi-

vidualized approach allow us to foster positive and meaningful relationships with the medical pa-

tients we service while maintaining the confidentiality they deserve. As a result our medical pa-

tients receive the very best care in service and the very best approach to medical treatment based

on their specific medical needs.

1 Applicant – Delta 11 Hawai’i Inc. Application, Merit Criteria, Section 9: Compliance for Certified Laboratory Testing

Delta 11 Inc. currently operates its own medical cannabis testing laboratory in California, we have

already created the protocols and methods for Cannabis testing. Since in Hawaii we cannot be in

any way involved with the lab testing we will work with a permitted Hawaiian certified HPLC lab

and provide them with our already created "methods" that would typically take months to create.

HPLC machine typically uses software called "Chem station". We will take our Chem station

"methods" created for Cannabis testing and provide them to an existing HPLC certified testing lab

in Kona. This will allow for immediate Medical Cannabis testing availability in Hawaii, while we set

up our lab.

The 3 main methods we will provide are for:

i) Flower testing

ii) Concentrates testing

iii) Infused products testing

Each one has a different chem station method and protocol that we have established. We will test

for all required Hawaii active ingredients, our experience with HPLC lab testing will help ensure a

smooth and efficient training of local HPLC testing lab in Kona.

In addition to Potency testing we will perform a UVVI (ultra violet visual inspection) inspection for

all product, if required we can also test for contaminants with the lab.

1 Applicant – Delta 11 Hawai’i Inc. Application, Merit Criteria, Section 10: Compliance for Signage, Packaging Labeling, & Chain of Custody

Delta 11 Hawaii Inc. will comply with all requirements for signage, packaging, labeling, and

chain of custody of products:

Labels for medical marijuana and medical marijuana products will be labeled using only black

lettering on a white background with no pictures or graphics and will include:

a) Net weight in ounces and equivalent physical weight of the marijuana used to produce the

product.

b) The concentration of tetrahydrocannabinol or tetrahydrocannabinol,

total tetrahydrocannabinol and activated tetrahydrocannabinol-A, and cannabidiol; as well as the

name of the laboratory that performed the testing. (THC, THC-A, CBD). (Delta 11 Hawaii Inc.

CEO currently operates an HPLC Lab in California, we will be able to quickly help a local

HPLC Lab in Kona to setup a fully functional Medical Marijuana Protocols and practices includ-

ing "Chem Station" methods for all required testing.)

c) The dispensary licensee’s license number and the name of the production center.

d) The batch number and date of packaging.

e) A computer tracking inventory identification number barcode generated by BioTrackTHC in-

ventory tracking and point of sale software which we currently are under contract with.

f) Date of harvest or manufacture and Use By Date.

g) Instructions for use of the specific product.

h) The phrases: “For medical use only”; Not for Resale or transfer to another person”; "This

product may be unlawful outside of the State of Hawaii and is unlawful to possess or use under

federal law", "This product has intoxicating effects and may be habit forming"; "Smoking is haz-

ardous to your health"; "There may be health risks associated with consumption of this product";


"This product is not recommended for use by women who are pregnant or breast feeding"; "Ma-

rijuana can impair concentration, coordination, and judgment. Do not operate a vehicle or ma-

chinery under the influence of this drug"; "When eaten or swallowed, the effects of this drug may

be delayed by two or more hours"; and a disclosure of the type of extraction method including

any solvents, gases, or other chemicals used (if applicable) BioTrackTHC’s label creation tool

enables licensees to create custom container-client labels with any fields necessary to comply

with applicable law. All aforementioned required fields can be added as variables. In addition to

this a user can add custom disclaimers and warnings. The system will automatically print the

container-client specific label upon completion of the sale. The name and address of the recipi-

ent, the quantity delivered, and the product name, potency, batch number, and lot number of the

product can all be recorded for each distribution.

The following list contains the fields already integrated into BioTrackTHC. Should the State de-

sire additional fields, BioTrackTHC will create and implement those fields per request. Includ-

ing: Custom Text Fields, Images, Lines, Additives, Barcode, Batch #, Custom Batch #, Customer

MMJ #, Customer Name, Date, Date and time, Employee Name, Employee License #, Grow Li-

cense #, Harvest Date, Inventory Grade, License #, MITS ID, Package Date , Package Weight,

Plant Birth date, Product Expiration, Product Ingredients, Product Name, Strain, Strain Type,

Testing Date, Testing Lab, Usable Weight, Weight,

Test Results, All Available: CBC, CBD, CBD-A, CBG, CBN, D8-THC, D9-THC, D9-THC-A,

H2O, Heavy Metals, Mold, Mildew, Total THC, Total Cannabinoids


Delta 11 Hawaii Inc. will comply with all state requirements required signage, we will not post

any signage other than a single sign no greater than one thousand six hundred square inches bear-

ing only "Delta 11 Hawai’i" in text without any pictures or illustrations; provided that if any ap-

plicable law or ordinance restricting outdoor signage is more restrictive, that law or ordinance

shall govern.

Packaging will be opaque to conceal contents and will be in childproof medical containers. We

will ensure that any new regulations are followed and that all existing ones are met.

1 Applicant – Delta 11 Hawai’i Inc. Application, Merit Criteria, Section 11: Disposal of Marijuana and Manufactured Products

A plan for secure disposal or destruction of marijuana and manufactured marijuana products;

Cannabis Waste Disposal Recycling Options

During or after a Harvest or Cure, a user would create a batch for the “green waste” which would

include broad leaf trim, and stems that weren’t going to be converted into a concentrated format.

All waste would be weighed, given it’s own 16-digit barcode, which is permanently stored in the

system prior to it being destroyed. When a BioTrackTHC user sends a sample for Quality Assur-

ance testing and the sample does not meet minimum standards, a user may;

1) Place the product into quarantine for destruction, or,

2) Convert the product into a different format. If the user converts the non- conforming sample

and originating lot, the new converted product must be retested.

Processed cannabis waste may contain trace amounts of THC post extraction. We have con-

tracted with two local companies to handle the waste management process, Pacific BioChar and

Island Herbs.

The following are proposed disposal options:


1) Fermentation:

All waste product will be chipped and mixed 50/50 with EM Bokahsi.

Packinto55gal.drumswithpressuretoextractair.

Sealandferment21days.

Incorporateintosoilfornutrientrecycling.

http://islandherbshawaii.net/bokashi.php

2. BioChar

Placeallwasteiteminaspecializedkilndesignedfornutrientcapture.

BioCharwastematerialonsite.

Incorporatebiocharintosoilfornutrientrecycling.

http://hawaiibiochar.com/

3. Rocket Composting

Add waste to rocket Turn on

Remove compost once finished

Incorporate compost into soil for nutrient recycling

Successful disposal method for Medical Cannabis in the UK

http://www.tidyplanet.co.uk/our-products/the-rocket/

http://www.tidyplanet.co.uk/our-products/the-rocket/


The BioTrackTHC MMJ Tracking System tracks and reports on all disposal of marijuana and

marijuana products within a licensed facility. The system allow for eh adjustment of inventory

quantities as the result of both non-sales operational activities (such as disposal, wastage, mois-

ture loss, mistakes, and inventory audits) and external factors (such as theft and seizure by law

enforcement). Data related to disposal information may include, but is not limited to: the amount

disposed, reasons for disposal, day/time, identity of the employee(s) conducting the disposal, and

manner of disposal in addition to all product-related data such as inventory classification, etc.

1 Applicant – Delta 11 Hawai’i Inc. Application, Merit Criteria, Section 12: Ability to Ensure Product Safety

Ability to ensure product safety, in accordance with this chapter and sections 329D-8, 329D-10,

329D-11, HRS.

The Delta 11 Hawai'i Inc. Production Center Cultivation team consists of experienced Medical

Cannabis cultivators that are experts in the Delta 11 Inc. methodology and cultivation system

which has been developed by our CEO in California. Our cultivation system is state of the art.

We are able to control environmental factors to maintain ecologically friendly cultivation cen-

ters. Our team utilizes standards of practice that ensure consistent cultivation of medical grade

cannabis. Our unique cultivation system ensures the highest quality while leading the industry

safety standards by testing all our products for safety and potency.

By using HPLC (High powered Liquid Chromatography) testing we determine active ingredients

potency, thereby ensuring that all our medical patients take appropriate dosages. Our team uses

UVVI testing to ensure medical cannabis is mold and mildew free. The Delta 11 Hawai'i Inc.

Production Center Cultivation team uses chemical-free soils and nutrients and will never use any

pesticides.

Medical Cannabis Production Center:

The Production Center Product team consists of experts in manufacturing and design of Delta 11

Hawai'i Inc. medical cannabis based products. A wide variety of medical cannabis based prod-

ucts will be available to medical patients to better suit their individual medical needs as allowed

under Hawai’i Act 241. For example, those with arthritis pain can use a topical that helps reduce

pain and swelling. For people who do not want to smoke cannabis we provide alternatives such

as capsules that can be taken instead or tinctures that can be taken orally in the form of drops.


For seizures we create a CBD rich product that has very little psychotropic effect but amazing

effects for people with seizures and Migraines.

Quality in production starts with safe and consistent growing methods. Delta 1 Hawai’i inc.

growing methods:

A) Maximize environmental protection – our regenerative and vegan methods ensure:

• Zero water waste through patent-pending irrigation techniques that eliminate evapo-trans-

portation losses and eliminate run-off.

• Minimize water use per above. No other commercial grow has incorporated our state-of-

the art irrigation techniques. Typical hydro operations waste up to 40% of irrigation wa-

ter and often create wastewater or runoff with nutrients and pesticides that can burden

wastewater treatment systems or contribute to algal blooms and eutrophication in water

bodies.

• Zero runoff per above

• Re-use and building of soil and soil health. Most grow operations throw their soil away

after one cycle of growing, which is extractive, not sustainable, and increases energy con-

sumption.

• Healthy soil and plants, minimizing the need for organic pest controls.

• Safe, organic, food based proven pest controls used only if needed

• No contamination - vegan grown on-site fertilizers are food grade and if spilled won’t

harm people, plants, or animals.

• Local sourcing of amendments and microorganisms that reduces carbon footprint and

maximizes benefit to local economy compared to importing, upon which most grow oper-

ations rely.


B) Ensure Patient Safety and Product Quality – Chemical and pesticide free, nutrition

grown, regenerative practices guarantee:

• No crop/food safety handling concerns – vegan farming eliminates all crop food-safety

handling concerns that are present with synthetic or animal by-product fertilizers.

• No synthetic fertilizers – all locally, sourced food grade inputs.

• No toxic pesticides or herbicides or poisons – all controls are food grade.

• Soil and plant health and medicine quality maximized through nutrition grown methods.

Healthy soil and plants also reduce the need for organic pest controls.

All products will be tested for potency and safety with a locally contracted HPLC certified lab in

Kona. We will test for molds and mildews as well as potency testing to ensure product is safe

for consumption.

Delta 11 Hawai’i inc has contracted with BioTrackTHC to maintain inventory tracking and pa-

tient control. After a testing laboratory has entered sample test results into the System, the licen-

see retrieves the testing laboratory results and the System applies those results to the original lot

from which the sample came. Only if the inventory item has a status of “Passed QA” can it be

placed on a manifest. A registered organization user cannot, under any circumstance, place an

item on transportation manifest if that item requires testing and does not have a “Passed QA” sta-

tus (e.g. not yet tested or failed testing).

BioTrackTHC automatically syncs testing data upon receipt from a certified testing location.

Testing will ensure the product is free of contaminants with consistent THC and/or CBD levels.


Furthermore, every plant interaction is recorded, including but certainly not limited to what addi-

tives are used and when, allowing cultivators to replicate results or make applicable changes to

increase plant quality and consistency. BioTrackTHC syncs testing data to the applicable plant

batch or barcode for easy display and retrieval. To simplify the process that information can be

directly ported onto the associated product labels.

All aspects of the marijuana plants, byproduct wastes, weights, ID numbers and associated data

is stored in the system indefinitely. Destruction event information and explanations are also doc-

umented and stored within the BioTrackTHC system. This data cannot be modified or deleted by

the cultivation center employees or even by BioTrackTHC.

BioTrackTHC records manual inventory adjustments through a detailed notes section. The rea-

son for disposal and, if applicable, disposal company are recorded and archived to the 16 digit

barcode associated with the disposed cannabis. As with all transactions in the BioTrackTHC sys-

tem, the employee responsible for the transaction is required to enter a PIN number or biometric

fingerprint recording the date, time, and reason for the transaction.

All medical cannabis and manufactured medical cannabis products shall be secured in a locked

room in 1600 lb safes bolted to the ground at our production facility.

All Cannabis produced will remain under constant live high definition video surveillance with a

30 day online backup of video recordings.

Once plants are harvested they will be moved to the production facility next door however they

will never leave video surveillance. Once the product is ready for delivery to the storefront, our


secured truck will arrive with 2 security and will once again always be under video surveillance

as our secured truck will also have live security video surveillance.

The product will only be out of surveillance after it has been sold to a qualified customer and ac-

counted for in our BioTrackTHC system. For more information on our Security of inventory

please refer to our security section in our business plan.

1 Applicant – Delta 11 Hawai’i Inc. Application, Merit Criteria, Section 13: No History of Business License Revocation

No members of Delta 11 Hawai’i Inc. has any history of having a business license revoked. Included

is our Certificate of Good Standing. All other records are available upon request.

hawaii state department of health · 2016. 7. 4. · since 2011, delta 11 inc. has operated a legal...

Documents