Foundation Harmony Application to Establish and Operate a Medical Marijuana Alternative Treatment Center
"In Spe Misericordia" "Hope is in Compassion"
Introduction to Foundation Harmony
Foundation Harmony(FH) is organized as a non-for-profit corporation incorporated in the State of California as a domestic non-profit corporation with Tax Exempt Status under section 501(c)(3), and registered for authority in the State of New Jersey as non-profit organization with no state tax exemption (Title 15A). We believe that Foundation Harmony is uniquely qualified to design, implement and operate the Alternative Treatment Center (ATC), and develop a medical model of care in Medical Marijuana Program. Mission:
Our mission is to build the best ATC as a "National Medical Model" in New Jersey. FH can provide comprehensive, community and clinically based services and be a reliable and legal medical marijuana source for seriously ill patients throughout Northern New Jersey. FH ATC will operate as non-profit organization that builds community and helps cultivate healthy lives by providing best quality medicine, emotional support, and personal development services to patients affected by debilitating medical conditions. FH will also provide registered patients and healthcare providers with current, scientifically and statistical data, necessary for clinical research.accurate information about medical marijuana The focal point of the operations is the creation of a facility that will be fully compliant with New Jersey Compassionate Act and Rules and Regulations issued by New Jersey Health Department, and compassionately assist North New Jersey terminally and chronically ill registered qualifying patients with adequate, safe, consistent, secure, clean and legal affordable supply of medicine, while educating them regarding safest and the most effective ways of medical marijuana use. FH believes that we have a social responsibility to find innovative ways to improve the quality of life of people with debilitating medical conditions in the community. Medical marijuana is supposed to be an alternative medicine for suffering patients, not an alternative money market for greedy individuals! We will work to be deeply respected by our future registered patients and/or their primary caregivers and the community in which we live and work and in full compliance with all Rules and Regulations of New Jersey Health Department and Senior Services and aspects of New Jersey Compassionate Use Medical Marijuana Act. General Philosophy:
The general philosophy of future FH ATC is to create a family environment, where every patient feels special, secure, comfortable, and welcome and receives the highest possible quality of medicine. We will take care of every patient and establish a relationship with him/her in order to understand his/her needs. We know that working with so ill people is a very demanding task. Our Page 1 of 85
employee will be strong and good listeners, and very concerned about our future patients' health. Our goal is to achieve excellence at all levels, ensuring that our services reflect the highest standards of quality and that all our methods are legally and ethically correct. Foundation Harmony officers and employees are willing and promising to work in strict compliance with New Jersey Compassionate Use Medical Marijuana Act, with issued by NJ Health Department Rules and Regulations for ATC and according Federal Law. Foundation Harmony is against of drug trafficking activity, violence, sales drugs to minors, illegal possession or sale of other controlled substances. We must defend the registered patients, primary caregivers, the community and our children from illegal drug activity in our society! We are eager and willing to be at the forefront to ensure registered and qualified patients' safe access to high quality services and medicine. Objectives:
To implement the rules based on clinical standards designed to protect the general public's safety as well as safety of participating patients and their caregivers, Foundation Harmony officers placed on themselves the highest quality standards to provide the entire industry in New Jersey in every aspect of operation: from security, best quality top medical marijuana, stable and consistent pricing, to constant education primary caregivers serving their interests.of personnel and qualifying registered patients and their Foundation Harmony is dedicated to the following objectives for the benefit of its future registered patients: - Provide a steady supply of high quality (including purity and consistency of dose) medical marijuana to registered qualifying patients for affordable and reasonable prices. - Help improve quality of life of the patients through improved symptom management, patient's self-assessment management system and reduce emotional distress. - Provide high quality products such as Topical Formulations, oral lozenges, vaporizers, pipes, personal microscopes for personal medical marijuana quality testing and personal portable scales, necessary for accurate dosage of medical marijuana. - Provide registered qualifying patients and their primary caregivers with up to date , scientifically accurate information about medical marijuana. - Provide registered qualifying patients and their primary caregivers with up to date reliable resources, regarding State and Federal statutes related to the use of medical marijuana. Keys to our success:
1. The majority of our company officers and future employees are women, having experience in medical field. They are capable to provide a passionate atmosphere of caring and warmth to the registered qualifying patients. Page 2 of 85
We are building a well-kept operated facility, paying the great attention to the human factor in delivering of our services, which will be a model of women's representation in the Medical Marijuana Industry. FH officers are relying not only on the best quality of medical marijuana products and services, but also on the right packaging of the products and outstanding sanitation and maintenance of the future facility. 2. FH is relying on a very well planned hiring, training and educating practices and will provide the necessary tools for the employees to succeed in the new industry. Our officers and employees are already educated in medical marijuana industry and have certificates from the Greenway University - the first and the only in the Nation accredited medical marijuana university. They visited several dispensaries and growing facilities, medical marijuana testing laboratories in the state of Colorado and several MMJ and Plant Medicine exhibitions in different states, getting the broad necessary knowledge in medical marijuana industry. Foundation Harmony has the interest in employing professional medical personnel, nurses, social workers, who will teach the qualified registered patients and primary caregivers with the safest techniques and alternative methods of using medical marijuana. People with such qualifications know how to deal with sick patients and their primary caregivers from their previous job experiences. They are eager to improve the quality of life of the qualified registered patients through compassionate care, education and professional conduct. Seeing people become better health wise or feeling better is an amazing feeling, and our employee will become attached to the patients over time. 3. In an effort to build the modern state-of-art growing facility and grow the best quality of medicine, FH will work in cooperation with growing consultants from other states, and will hire knowledgeable specialists in horticulture. 4. Foundation Harmony already contacted Prince Insurance Group, and has their assurance letters for providing in writing our ATC with Lloyds of London insurance, if FH ATC is in compliance with all necessary security measures and all necessary rules and procedures according to rules and requirements issued by New Jersey Health Department. Prince Insurance Group has the exclusive Lloyds of London insurance policy for medical marijuana industry, being the biggest insurance company in medical marijuana industry in USA. 5. Foundation Harmony is already engaged in the outreach activities in the community in the Medical Marijuana Program (MMP). In this regard, FH has developed and is maintaining a website to inform all interested parties about MMP: www.harmonyfoundationmmjnj.com According to Google data and other Merchant statistics our website is visited by at least 700 people per month, and we have a lot of phone calls and visits from the interested parties of the community.
Page 3 of 85
The website is done in the form of electronic library and includes resent research on the efficacy and risks using medical marijuana, changes of Federal and State Laws, updated regulations from NJ Health Department and links to other resources and holistic ways of healing. Patient's safety will be a primary concern of FH. There are clearly health risks associated with medical marijuana use, especially while smoking medical marijuana. It will be a policy of FH to promote through our website the information about other methods of medical marijuana use. 6. Foundation Harmony developed the relationship with the First in the Nation accredited medical marijuana university Greenway University, and donated money and organized a First in New Jersey educational seminar about MMP and its implementations in the other states for all interested parties of the community. The seminar was held on June 5 and 6, 2010, and was covered in NJ newspapers, TV news, and internet information. The invitations were also sent to NJ Senators and Mayors. (See information on our website and the internet) 7. FH officers participated in the Paterson Mayoral and City Candidates meeting, April 22,2010, where they promoted FH company's mission to the attendees and Mayor candidates and had the great support from the community members. 8. Future FH ATC will have a Medicine Discount Program for the patients who are eligible and in need. FH will operate as a non-profit organization. As such, it will allocate a portion of its net revenues helping those of its registered patients, who cannot afford either all part of their medical marijuana. FH will allocate a special amount of funding each year to fund its discount program. Discount will be based on the patient's application of economic need (defined by income) and will enable eligible members to receive the medical marijuana and paraphernalia they need for their better life quality. Understanding our patient's health and socio-economic status is the important part of FH ATC work. Medicine Discount Program is one of the most rewarding aspects of our future work. 9. Foundation Harmony established partnership with professional medical offices, providing great medical and Holistic services, where FH would refertreatment it's registered qualifying patients, for complimentary or discount services for achieving the best outcomes. Foundation Harmony has the Engagement letter from Self-Awareness and Transformation Center, located at 126 Park Ave, E. Rutherford, NJ,07073 about offering free (once a week) professional services like, yoga, sound and color healing therapy, energy healing, acupuncture, meditation techniques for registered patients of ATC referred to them by FH, which a lot of registered patients cannot obtain by themselves. For this purpose we will allocate a portion of our future revenues. Foundation Harmony has the Engagement letter from Tri State Health and Wellness Medical Center, located at 31-00 Broadway, Fair Lawn, NJ 07401. This medical center is going to provide professional services: Acupuncture, Massage Therapy, Physical Therapy, Vitamin and Page 4 of 85
Mineral Supplementation through Intervenal Infusion, Drug, Alcohol and other Controlled Dangerous Substances Abuse Treatment, Pain Management and Hypnosis for registered qualifying patients of Foundation Harmony ATC. FH will pay for these services if they are not covered by FH registered patients' insurances (partially or in full, by decision of FH ATC Board of Directors) from the future revenues. Foundation Harmony has the engagement letter with Dr. Shtillman, DDS from CavityFree Dental Care that he would provide professional dental services to "special need" patients, referred to him by FH. FH ATC will cover the dental treatment cost for such patients in Hackensack Hospital facility if some of these services are not covered by patient's insurances ( as anesthesia), by the decision made by the Board of Directors. 10. FH is already engaged in a medical marijuana clinical research together with Beilis Development Laboratory located in NJ, working on the development of a professional formulation for the increased transdermal delivery of cannabinoids. Clinical studies are held in California. 11. FH is planning to build on its premises a laboratory for Microbiological Screening, Foreign Matter Inspection and Cannabinoid Profiling, which will ensure the quality of the medicine and the most accurate and comprehensive way to measure cannabinoids. Thank you for taking the time to read our mission and objectives. We hope that our application will show New Jersey Health Department Medical Marijuana Program that Foundation Harmony is a team of professionals, who are knowledgeable in nonprofit field, healthcare, horticulture, business and medical marijuana education, therefore, FH is capable of implementing its mission and goals! Evidence of compliance with N.J.A.C, 8:21-3A.18, with regards to inspection and auditing of FH ATC
The officers of FH ATC are assuring the NJ Health Department to be in compliance with N.J.A.C. 8:21-3A.18 with regards to inspection and auditing of FH ATC. FH ATC shall permit the NJ Health Department and authorized Federal, State and Local enforcement officials at to reasonable enter and inspect premises, and audittotheir recordsauthorized and written operating procedures, time andtheir in reasonable manner, the extent by law. FH ATC understands that this inspection and auditing will be done for the benefit of health and safety of the qualifying registered patients. FH ATC Operation Manual demonstrates compliance with NJ Health Department Rules and Regulations to the MMP, where all Policies and Procedures govern every aspect of our future operation which creates a corporate culture of compliance.
Page 5 of 85
FH ATC will maintain business records including manual or computerized records of assets and liabilities, monetary transactions, various journals, ledgers, and supporting documents, including agreements, checks, invoices, and vouchers that the FH ATC keeps as its books of accounts. FH ATC will have a contract with the best known software providers of business record keeping and tracking system for medical marijuana dispensaries. FH is committed to work with New Jersey Health Department, to improve our policies and procedures as NJ MMP evolves. FH anticipates that NJHSS Rules and Regulations establish the beneficial, social impact in inhibiting the criminal activity in the community. FH ATC will provide 2 monitors for remote viewing via telephone lines in State offices. This system shall be approved by MMP prior to permit issuance. Original tapes or digital pictures produced by ATC system shall be stored in a safe place (vault) with a 30 day archive. FH ATC future Policies and Procedures can be seen in our Application and Operation Manual. Appendix K: Signed Letters by the Board of Directors with regards to inspection and auditing of FH ATC. Evidence of the principals, board members, owners, and employees to cooperate with a criminal history record fees background pursuant to N.J.A.C. 8:64-7.2, including payment of all applicable paid by thecheck ATC or the individual.
FH ATC principal officers and employees will cooperate with criminal history background check pursuant to N.J.A.C. 8:64-7.2, N.J.S.A. 24:6I-4 and comply with procedures established by the Division of State Police pursuant to N.J.A.C. 13:59 for obtaining readable fingerprint impressions. Our commitment to track the record of the Board of Directors and employees demonstrate our serious commitment to protect the future ATC premises, the staff, registered patients and neighbors in the community from criminal activity, theft, abuse or other diversions of MMJ surrounding the implementations of MMP in other states such as California. Written Consent of principal board members and employees to cooperate with the criminal history background check pursuant to N.J.S.A. 24:6I-4 and compliance with N.J.A.C. 13:59 for obtaining readable fingerprint impressions is submitted in Appendix K for every officer and employee. Payment of applicable fees associated with the criminal history background check will be submitted on demand. All principal officers of FH ATC executed a certification stating that he/she submits to the jurisdiction to the courts of the State of New Jersey and agrees with all the requirements of the laws of the State of New Jersey pertaining to the Medical Marijuana Program. Appendix K: Certifications of Submission to the Jurisdiction of the Courts of the State of New Jersey.
Page 6 of 85
Reporting requirements to NJHSS from ATC:
FH ATC will submit to NJHSS:
The number of registered qualifying patients and registered primary caregivers;
The debilitating medical conditions of qualified patients;
Patient demographic data;
Program costs;
A summary of the patient surveys and evaluation of services; and
Such other information may be required by NJHSS.
CRITERIA FOR APPLICANTS [TOTAL WEIGHTED REQUIREMENTS up to 300 points] Criterion 1: Submission of Required Information Regarding App licant & Facility [MANDATORY REQUIREMENTS] Measure 1: The applicant shall provide the proposed legal name and the following documents applicable to the applicant’s legal status . Supporting documents should be included as Appendix A. Certificate and Articles of Incorporation and By-Laws for corporations Organizing documents for associations Evidence of nonprofit status Certificate of good standing issued by the New Jersey Secretary of State Appendix A: Certificate and Articles of incorporation, By-Laws of FH, Evidence for non-profit status, Certificate of good standing issued by NJ Secretary of State.
Measure 2: The applicant shall provide the proposed physical address (es) of the ATC, if a precise address has been determined. Supporting documents should be included as Appendix B. For each proposed physical address, the applicant shall provide legally binding evidence of site control (e.g., deed, lease, option, etc.) sufficient to enable the applicant to have use and possession of the subject property including, but not limited to, length of term of use and possession. Response:
The facility would be located at It is a 66,500 sq feet masonry building, having 1 story part for plant cultivation facility and two-storied office part.
Page 7 of 85
The facility is housing the whole scope of FH ATC operations: Dispensary and Plant Cultivation, thus providing additional security. All windows of plant cultivation area on the first floor will be blocked, making invisible all activities in this area. The windows in the office area on the second floor will have metal guards. The future FH ATC will have a huge parking lot of 71 parking spaces. A building is located in a low crime area of Secaucus; local Police Department is located in one mile distance. Secaucus has a crime index 184.2, comparing to 319.2 US average. Area of Secaucus municipality has a lot of substance controlled drug manufacturers located in the area. Exterior appearance of the facility will not have any influence on the neighborhood property value. Our closest neighbors in 100 feet proximity would be provided with names and phone numbers of FH ATC Board of Directors. The facility has a neighbor on the left side of the building, which is a furniture shipping company. Hours of operation and after hour contact information. The ATC will operate from 9 am to 9 pm with one-hour lunch break (the time will be decided later), seven days a week, Monday through Sunday, except National Holidays. Such long hours of operation is a measure to ensure that all our patients and their primary caregivers have enough time to reach FH ATC (some of them are working or live far from the ATC). ATC will not make exceptions to the hours by letting patients into the store when it is closed. After hour contact information for the use of Health Department, State Police, and other inspection agencies: Page 8 of 85
Margarita Ivanova: phone: Marina Karavas: phone: Ida Umanskaya: phone: Dmitri Bajanov: phone FH chose located this address at for ATC, because it is It has the best accessibility by any type of favorably in Northern New Jersey region. public transportation and through all major highways. •
•
Prime industrial building located off Route 3 and the New Jersey Turnpike at Exit 15X in the Harmon Cove Industrial Park. The Garden State Parkway, Routes 17, 46, 1 & 9, and arteries to I-80, I-95 and I-280 are easily accessible. Many bus lines service Harmon Cove from New York’s Port Authority and various parts of New Jersey. Train service is available at the nearby Secaucus Junction Train Station.
The facility is located near major Northern New Jersey Hospitals: Name of Hospital Distance from facility_(miles) Caligor Medical Hospital 0.4 Meadowlands Hospital Medical Center 1.1 Christ Hospital 3.1 Palisades General Hospital 4.2 Hoboken University Medical Center 3.0 St. Mary Hospital 3.1 Jersey City Medical Center 6.0 Pollack Hospital 5.0 Hackensack University Medical Center 10.0 The Concentra Urgent Care is located on 30 Seaview Drive, in a 25 minute walking distance from the future facility. (201) 319-1611. FH has begun a conversation with Concentra Care, personally with William Miller, Health Service Manager about possible future affiliation. See Criterion 3, Measure 2 for detailed information about the facility location. Measure 3: The applicant shall provide evidence of compliance with the local zoning laws for each address or proposed location for an ATC. If the current zoning is not appropriate for a given address or location, identify any required zoning variance(s) and the applicant’s actions taken to date to obtain such approval(s) and/or variance(s). Supporting documents should be included as Appendix C. Response:
Page 9 of 85
Shown below is an abstract from the Hackensack Meadowlands District Official Zoning Map, showing the location of future FH ATC. Our future facility will be located in Secaucus which is a light industrial zone. Light industrial zoning ordinance allows: Agricultural processing plants, bakery, distributing plants, food processing ( except fish, dairy, meat, poultry, yeast, vinegar), laboratories for research and development, uses handling and storage, any retail sales, that have to be conducted within anfuture enclosed building. FH ATC operations are in full compliance with Secaucus light zoning ordinance. Appendix C: Letter from Town of Secaucus Construction Department, Municipal Government Center, Construction/Zoning Vincent Prieto; cc: Mayor-Michael Gonnelli, Town AdministratorDavid Drumeler.
Page 10 of 85
Measure 4: The applicant shall provide evidence that all of the physical addresses and proposed locations provided in response to Measure 2 are not located within a drug-free school zone. The applicant shall provide the distance to the closest school from the ATC. Supporting documents should be included as Appendix D. Response:
FH ATC considers community safety its top suited priority. Throughout site selection FH considered the proposed address as as perfectly in the low crimethe industrial area. process, The Google maps providing evidence that the proposed location is not located within 1000 feet of schools and other child-oriented facilities, churches, temples and cemeteries are included in Appendix D. Nearest school: Clarendon No. 4 Elementary School - 1.0 miles from facility. Nearest church: Shree Swaminarayan Temple - 0.9 miles from facility. Appendix D: Evidence that the physical address of the proposed location provided in response to Measure 2 is not located within a drug-free school zone, letter from a real estate agent. Measure 5: The applicant shall provide a legible map or maps of the ATC service areas by Zip Code to be served by ATC. Supporting documents should be included as Appendix E. Response:
A legible map of Northern New Jersey (Bergen, Essex, Hudson, Morris, Passaic, Sussex and Warren counties) (rotated 90 degrees to fit the page) of areas that could be served by FH ATC is submitted below. Appendix E: FH ATC service areas by Zip Code.
Page 11 of 85
Page 12 of 85
Measure 6: The applicant shall provide the role, qualifications, name, address and date of birth of each staff member and the role, name, percentage interest, address and date of birth of each principal, officer, board member or partner of the ATC. In the event that an individual has not yet been identified, a statement of required qualifications and position, Description shall be included as Appendix F. Response: FH is a non-profit organization, thus, there are no owners of the company. No principal, officer, board member or partner has a percentage interest in the company.
Board of Directors Name
Address
Date of birth
Address
Date of birth
Marina Karavas Ida Umanskaya Margarita Ivanova Dmitri Bajanov
Employees Name
Anastasia Vaynberg Georgiy Akopov Nino Manelashvili Boris Slutskiy Larissa Seymour Valeriya Shlapak Maia Gogua Yuriy Rybakov Elizabeth Sonnenthal
H.
Page 13 of 85
Marina Karavas, Executive Director Education:
1. Academy of Law, Moscow, Russia 2. Applied to Benjamin Cardozo School of Law, New York, NY 3. Has a Certificate of Completion from Greenway University after having 20 hours of accredited training. Experience: Has 13 years of S CORP. ownership, providing services for clients, communicating with NYS Department of State and New Jersey Department of Treasury. Today is working in Foundation Harmony. Participated in organization of the first in New Jersey educational seminar in Medical Marijuana Industry, performed by Greenway University in June 2010. Has a great experience in volunteering for elderly people of Bergen County, providing them with interpreting services, in particular Social Security Office of Bergen County. She also works as a volunteer for the LGBT Community Center in New York (www.gaycenter.org). Ida Umanskaya, Director of Holistic and S ocial Operations Education:
1. State University, St.Petersburg, Russia University of Precise Mechanics and Optics, MS equivalent in Optical engineering and design 2. St.Petersburg School for Preparation and Improvement of Qualification of Nurses 3. New York Touro College (1993-1995) Bachelor of Health Sciences and Health Information Management 4 .Clayton College of Natural Health, Naturopathic Doctorate degree ( pending) Studied courses: Herbology, Iridology, Homeopathy, Cancer Prevention, Detoxification and Healing, Naturopathy, Fundamentals of Nutrition and Dietary Influences on Diseases. 5. Has a Certificate of Completion from Greenway University after having 20 hours of accredited training. Experience: Worked as a manager in several Medical Practices, sales manager and customer service in Art Group, she has her own skin care product line. Page 14 of 85
Today is working in Foundation Harmony, participated in organization of the first in New Jersey educational seminar in Medical Marijuana Industry, performed by Greenway University in June 5-6, 2010. Educates and informs community members about medical marijuana program by phone or by email. Today is working with Beilis Development, NJ laboratory, on development of patented (by Ida Umanskaya) concept and formulation (trademark IMMUNIK) for healthy and safe, FDA registered, transcutaneous cannabinoid delivery for registered qualified patients. Margarita Ivanova, Director of Administration and Finance Education: 1) Berkeley College, West Paterson, NJ Bachelor of Business Administration in Accounting
2) Has a Certificate of Completion from Greenway University after having 20 hours of accredited training. Experience:
. Responsibilities:
Handle financial transactions, recordkeeping, and payroll Reconcile, evaluate, and resolve collection accounts Create invoices and monitor overdue accounts Supervising the admission process, medical billing, coding, and arbitration Distribute insurance and cash payments to appropriate patient accounts Verify patient eligibility and obtain pre-certification Heavy patient phone contact and appointment scheduling Assist four Radiologists with everyday assignments
Dmitri Bajanov, Director of Operations
Education: Gorkovsky Military University, MS in Business Administration Experience: 1) Worked as the Chief Manager with responsibility for technical, food and other necessary provision of seventy commercial ships and shore warehouses. 2) Opened and managed one medical clinic with a group of seven doctors in New York, Brooklyn.
Page 15 of 85
3) Today works as the President of NGU Omega Management Inc, owning and providing management for two medical clinics in Manhattan and Brooklyn with 30 health professionals working in them. Mr. Bajanov is extremely knowledgeable in the medical industry business: in rules and regulations regarding patient's confidentiality, medical records safety, reporting to health department, planning, recruiting ,coordination of services, managing finances, in provision of medical and other office equipment, software and supply provision and oversight of medical clinics. His ships), previous backgroundthefrom Russia,( fully supplying numerous commercial is ofexperience great value and for developing business and security plan for FH ATC in detail and in the whole. Qualification and education of future FH ATC employees Maia Gogua, future grower
Education: 1) Georgian Institute of Subtropical Economy, Georgia - B.S. in Agronomy and Horticulture Experience: More than 10 years of experience in mass indoor and outdoor growing, specializing in growing of tea, tobacco, tomatoes, lemons, and ethereal cultures. She is experienced in all steps of horticulture from seedling to harvesting. 2006-2009, worked as a dental assistant in the dental offices of Dr. Bodneva. Since 2009 she works as a dental assistant in "Periodontal Associates" office in Englewood. Larissa Seymour, future Social Worker
Education: 1) Engineering Academy, Zaporoznye, Ukraine - B.S. in Ecology of Natural Resources2) Adelphi University, Garden City, NJ - M.S. in Social Work Experience: In 1985-1993 worked as a Chemical Engineer in Ukraine. Today works in Merc&Medco Health, Inc. as a Business Analyst. Elizabeth H. Sonnenthal, future Social Worker
Experience Works as the Assistant Director, Welfare department, Borough of Cliffside Park Performs all duties as a Social Worker, opening cases based on eligibility; interviews clients, making on-going decisions about their status; prepares checks, paying out thousands of dollars each month; steers clients and non-clients in the right direction, with information whatever medical, social and other services they might need. Elizabeth has a knowledge of several foreign Page 16 of 85
languages, has exceptional communication, relationship-building and interpersonal leadership skills; committed to quality and excellent customer service. FH ATC is happy to have such employee in its stuff. Elizabeth can bring her invaluable experience to FH ATC, its registered qualifying patients and primary caregivers, and help in FH ATC charitable program. Nino Manelashvili, future receptionist
Education: Tbilisi State University, Tbilisi, Georgia - MS in Liberal Arts Experience: Worked as a Receptionist in Dr. Fishbein's Office, West Orange, NJ. Anastasia Vaynberg, future receptionist
Education: Lincoln Technical Institute, Paramus, NJ - Medical Coding and Billing Experience: In 2005-2010 worked as a Medical Manager and Biller in several medical offices. Today works in Elite Physician services as a Medical Biller. Boris Slutskiy, future Shift Manager
Education: 1) Academy of Economy, Moscow, Russia - B.S. in Food Sciences and Human Nutrition 2) Global Institute of technology, New York, NY - Certificate in MVS Programming Experience: In 1990-1998 worked in Beak Stearns and American Express Bank. Georgiy Akopov, future assistant grower
Education: 1) Bauman Moscow State Technical University, Moscow, Russia - B.S. in Optical Engineering;2009 Developed new Optical Methods of Forensic Document Examination for Criminal Forensic Laboratory researches. 2) Bergen Community College, Paramus, NJ - AS in Natural Sciences and Biology (Pending) 3) The Diploma of Higher Education in Cannabis College Amsterdam (online). Page 17 of 85
Experience: Currently is working in Foundation Harmony as a Volunteer. Valeriya Shlapak, future monitoring specialist
Education: 1) andMagnitogorsk ProgrammingState Technical University, Magnitogorsk, Russia - M.S. in Computer Sciences Yuriy Rybakov, future Chief of FH security guards
Education: Tyumen University of Oil and Gas, Russia- MS of Science and Engineering Gladiator Security Guard Training School, NY-Certificate of a Security Guard Centurion Fire Science Institute, NY- Fire Safety Director (F-58). NYC College of Technology- Refrigerating System Operating Engineer Certification Program Pace University, NY-Emergency Action Plan Director (F-59) Experience Fire Safety/ Security Officer position in Hotel Plaza-Athene, 37E 64 St, New York, NY, 10065. At Present-Deputy Fire Safety Director ( LB&B Associates Inc.) at the Federal Office Building, 201 Varick St, New York, NY,10014 Yuriy Rybakov's education and experience will help FH ATC to interview and hire security guards and to develop the best security measures possible for FH ATC operations. NOTE: FOR OFFICIAL USE ONLY, LIMITED FOR PUBLIC REVIEW, CONTAINING CONFIDENTIALITY AND PROPRIETARY INTELLECTUAL PROPERTY. Written above is the list of employees, who are ready to be employed by the future FH ATC. Other employee staff would be hired as soon as FH gets the ATC license permit. Appendix F: Copies of Diplomas, Certificates and other credentials of the Board of Directors, employees; a List of positions and qualification descriptions for FH ATC. Appendix G: Operation Manual: Job description on p. 93
Page 18 of 85
NOTE: FOR OFFICIAL USE ONLY, LIMITED FOR PUBLIC REVIEW, CONTAINING CONFIDENTIALITY AND PROPRIETARY INTELLECTUAL PROPERTY. Measure 7: Disqualifying Drug Offenses: In considering any application for an ATC permit, anfactors applicant must disclose the Department shall consider, at a minimum, the following in reviewing the quand alifications of those persons applying: Response:
The Board of Directors and all future staff members are ready and eager to participate in criminal background check according to NJ Rules and Regulations in MMP. The forms of Submission to the Jurisdiction of The Courts of the State of New Jersey and Consent to submit to a criminal history record background check pursuant to N.J.S.A. 24:6I-4, together with applicable fees will be submitted by the Executive Director of FH on demand from NJHSS if FH is granted the permit to operate as an ATC.
Page 19 of 85
Measure 8: The applicant shall provide the identities of all its creditors, if any. Response:
Measure 9: The applicant shall provide a list of all persons or business entities having direct or indirect authority over the management or policies of the ATC. Response:
Persons having direct authority over management and policies of FH ATC are the Directors of FH ATC. No businesses, or other than officers from the Board of Directors, have direct or indirect authority over the management or policies of FH ATC: Marina Karavas Ida Umanskaya Margarita Ivanova Dmitri Bajanov
Measure 10: The applicant shall provide a list of all persons or business entities having an indirect interest in the ATC. An indirect interest includes an interest in the land or building where the ATC will be sited. Response:
There are no persons or business entities having the direct interest in ATC. The Landlord, who will have the indirect interest in FH ATC operations, deriving economic benefit from renting FH it's building, can have the same economic benefit by renting the facility to the other businesses. Measure 11: The applicant shall include the required application cover sheet and attestation statement signed by its chief executive officer or other individual authorized to make legally binding commitments on its behalf. Response: Appendix A: Application cover sheet, Attestation statement signed by FH CEO.
Page 20 of 85
Criterion 2: Submission of Required ATC Operational Information [TOTAL WEIGHTED REQUIREMENT UP TO 80 POINTS] Measure 1: The applicant shall provide a draft operations manual and training plan which demonstrates compliance with Subchapter 9 of N.J.A.C. 8:64, the Rules Related to the Medicinal Marijuana Program and which addresses ATC General Administration Requirements for Organization and Recordkeeping. [WEIGHTED REQUIREMENT up to 40 points] Response:
As a result of FH Board of Directors experience, and consulting with Grow SetUp Inc, there is the Operation Manual, including procedures, policies, drug and alcohol- free policies, training and educational materials, samples of self-assessment records and other necessary information to ensure that FH ATC is able to meet NJHSS rules and regulations and the standards of medical marijuana industry facilities. The Operation Manual will serve as a tool and reference resource for FH ATC officers, managers and employees. It has information and policies and procedures, regarding security measures adopted by FH ATC, and procedures, how to respond to emergency or robbery. There is also orientation, a stringenttraining, human operational resource compliance documentation confidentiality, policies and and procedures. Operationregarding Manual contains necessary educational, regulative and other important information in medical marijuana field. Employees would be informed prior to employment about criminal background checks, monitoring and security practices in FH ATC and random drug testing practices. It is a draft only, but will be developed in full with the help of professional human resource' management company, if FH is awarded with license to operate ATC in Northern NJ. FH ATC Board of Directors will ensure that Operational Manual is available for inspection by the Department, upon request. FH ATC Board of Directors will ensure that FH ATC Drug and Alcohol- free policies are available for inspection by the Department, upon request. FH ATC Board of Directors would publish all educational materials, after they are approved by the Department. Appendix G: Draft Operations Manual and Training plan. NOTE: FOR OFFICIAL USE ONLY, LIMITED FOR PUBLIC REVIEW, CONTAINING CONFIDENTIALITY AND PROPRIETARY INTELLECTUAL PROPERTY. Measure 2: The applicant shall provide a description of how the ATC will operate on a long-term basis as a not-for-profit entity and a business plan that includes, at a minimum, the following: [WEIGHTED REQUIREMENT up to up to 35 points] I. The applicant shall provide a detailed description about the amount and source of the equity and debt commitment for the proposed ATC. Page 21 of 85
a. The immediate and long -term financial feasibility of the proposed financing plan; b. The relative availability of funds for capital and operating needs; and c. The applicant’s financial capability. Response:
FH has the officially opened credit line- three million dollars, provided to future FH ATC by on favorable rate and with favorable conditions crediting.that FHastart up operations will be financed by It is of anticipated the notes and necessary financial documents will require FH to pledge the business assets and future accounts receivable as security. FH Business Plan is done for the future creditor and for assistance of NJHSS to consider FH financial capability to operate one of the Northern NJ ATC. It is based on the projected number of registered patients, projected price for medicine, and upon the information and numbers provided by FH ATC future consultants, contractors, affiliates and experts in medical marijuana industry. Neither FH, nor the Board of Directors or any of future consultants, contractors or employee give any warranty or make any representation, expressed or implied as to the accuracy or full completeness of any information and numbers contained in this Business Plan. All presented material and estimates numbers, ofconstitute forward looking the subjectiveoptions views and FH BoardFH's of Directors. They arestatements, also based represent on projected assumptions which FH believes reasonable enough, but which may or not be proved to be correct. Nothing in this Business Plan should be relied as warranty, promise or representation of the future FH ATC performance. Projection of the number of qua lified patients to be served in FH ATC
As of today we were unable to find any studies projecting the number of medical marijuana users nationwide. Our projected estimate may not be nor is it intended to be scientifically or statistically sound. A projection of the number of qualified patients to be served by FH ATC is difficult to make and a projection is not accurate due to several reasons: 1) We don't have any figures about the number of qualifying patients who are going to apply to MMP; 2) We don't have any figures about the number of patients which will be registered by NJ Health Department; 3) NJ Health Department makes no estimate or representation as to the number of qualifying patients. We can make our assumptions knowing:
The demographic data of Northern New Jersey, which FH ATC is going to serve;
Debilitating medical conditions of qualified patients for MMP in New Jersey; Page 22 of 85
Patient’s statistics and surveys from New Jersey Health Department and other statistical sources;
As of November 16, 2010, 56 doctors have signed up to recommend patients into the program according to NJHSS spokesperson Donna Leusner. On January 12, 2011 there were 68 doctors signed for MMP, according to Health Department figures published in the newspapers; The statistics ( 2007-2009) of the major qualifying diseases in North Jersey (cancer and HIV/AIDS); The number of ATC allowed by NJ Health Department in Northern region; We are assuming that some New Yorkers with debilitating qualifying conditions can change their residency for North New Jersey during the first two years of MMP implementation. It can be expected that many qualifying patients and primary caregivers will not join MMP, because some of them do not choose medical marijuana as their possible cure, others do not think that all necessary accommodations are made for their privacy and health needs.
According to survey done by Washington's Medical Marijuana information center the average consumption of patients with debilitating medical conditions is 1 oz. per week. FH assumes that every registered patient will consume the allowed limit of 2 oz. per month, though their finances may forestall their consumption. FH thoroughly studied NJ vital and health statistics from NJ Health Department and Senior Services last publications (2007 and 2009) for cancer and PLWHA, NJ Cancer Registry, State cancer and AIDS Profiles. 1. Cancer. According to these sources, Bergen County bears the greatest cancer burden in the state in absolute numbers. According to New Jersey Cancer Registry in 2003-2007 Bergen County had 28,491 new cases of cancer out of 252,000 statewide. Assuming that 2/3 of them can go through chemotherapy, and suffer from chronic pain and nausea; at least 18,000-19,000 people could be registered in MMP in Northern New Jersey. "Cancer is the number two cause of death in New Jersey and the cancer statistics will likely be fueled each year due to the increase among the population", (National Cancer Institute and Center for Disease Control and Prevention, State Cancer Profiles) even though over the past few years, significant improvements in regard of health care have been made. 2. HIV/AIDS Essex, Hudson and Passaic Counties are reported as disproportionably affected by HIV/AIDS in comparison with other 21 New Jersey counties. According to data published on December 31, 2009: Page 23 of 85
Living patients with HIV/AIDS (PLWHA): in Passaic county-2,587 people; Bergen county1,560 people; Hudson county- 4,623 people; Essex-9,584 people; Warren-115; Morris-702 andSussex-142. Newark (Essex County) accounts for 24% of deaths in NJ due to HIV disease, having only 3% of state population. 19,313.00 PLWHA patients can be registered for MMP in Northern New Jersey. Prevalence Rate: Persons Living with HIV/AIDS per 100,000 population
There are a number of other debilitating medical conditions permitting the NJ patient's registration for MMP, such as: seizure disorder, including epilepsy; intractable skeletal muscular spasticity; glaucoma; inflammatory bowel disease; Crohn's disease; multiple sclerosis, and etc. Also there is a policy of NJHSS to approve other conditions as debilitating medical conditions for MMP in two years. 3. Multiple Sclerosis. USA has a high incidence of Multiple Sclerosis (MS), approximately 0.3% of country population. There is no central registry of MS in New Jersey,
0.0 - 199.9 200.0 - 399.9 400.0 - 1199.9
but according to National MS Society New Jersey Metro Chapter, there are 13,000 New Jersey residents living with MS. We can assume that at least one third of them are residing in Northern Region (approximately 4,000 people).
4. Chron's Disease. 20% of adult population in US or one in five Americans has symptoms of Irritable Bowel Syndrome. Chron's Disease incidence is 1 in 544 of population or 0.18% of US population. Therefore, we can assume that there are approximately 8,000 of Northern Jersey Residents (4 million residents) are having Chron's Disease. 5. Epilepsy and Seizures. There is no central registry of Epilepsy and Seizures cases in US. From the mixture of sources, leading experts have arrived with such statistical data: there are 3 million active Epilepsy cases in US, where 10% of them fail to gain control of Seizures despite optimal medical management. 1 in 100 people will develop Epilepsy each year and the trend is the increasing incidence of it. 6. Amyotrophic Lateral Sclerosis (ALS). There is no New Jersey registry, but through statistical data we know that 30,000 Americans are affected by ALS, and the incidence is 5,600 new cases each year, 1-2 people per 100,000 each
Page 24 of 85
year. We can assume that approximately 50 people will be affected by ALS each year in Northern New Jersey. 7. Glaucoma. 2,000,000 of US residents have Glaucoma, 120,000 people are currently blind from Glaucoma, 5, 500 become blind from Glaucoma each year. Using this data we can assume that 0.65% of US population have Glaucoma, Northern New Jersey approximately has 30,000 residents affected by Glaucoma. New Jersey cannot be compared with other states because: 1) Every state has its own individual health statistics, and New Jersey ranks as 16th in the list of Healthiest States in 2007. 2) New Jersey MMP does not allow patients to grow their own medical marijuana. Taking into consideration that North New Jersey population is approximately 4 million people, the fact that some New York patients can change their residency to New Jersey, and a big number of severe debilitating diseases in North New Jersey, we assume that there can be at least 50,000 patients enrolled in MMP during three years. At the same time we anticipate that the majority of patients with debilitating medical conditions would not want to be registered in MMP and do not believe in medical marijuana cure. FH knows that NJ doctors are registering for MMP very slowly, thus the patients would be registered slowly and steadily too, especially for the first ramp-up year. According to assumptions mentioned above, FH anticipates having at least 1,500 registered patients for the first ramp-up year. Comparing to Montana and Rhode Island Health Department MMP Registry for 2010, we can observe a very rapid increase in the number of registered patients at the end of second year. We anticipate that at least 4,000 people could be registered in one of Northern Region's ATC-s. As for the third year, we are projecting a slow increase of approximately 600 new patients per year for one ATC, taking in consideration that NJHSS can give the permits to other ATC-s in the area. Also we can expect that some registered patients could decide not to use medical marijuana as their cure after the first year of its using, but at the same time some new debilitating medical conditions could be added by NJHSS. FH anticipates that there can be different incidents of temporary closing of one of two permitted in Northern Region ATCs, thus, one of the remaining ATC has to serve all registered patients. That is why each of permitted ATCs has to consider its capability to serve all registered patients of the whole Northern Region for some period of time. According to this statistical data, Foundation Harmony considers the projected location of ATC in industrial area of Secaucus to be very well suited for the North Jersey population qualifying to be registered for MMP, and we can provide the minimal rough figure of at least 20,000 patients that can be served by FH ATC facility if needed. We will have all necessary funding, Page 25 of 85
staff, and the easily expandable size of growing facility area, special growing techniques, long hours of operation necessary to" scale up" FH ATC according to patient demand. Our consultants and future growers are knowledgeable to build the plant cultivation facility adequate enough for a consistent and adequate supply of medicine. FH understands that ATC is a new model for providing medical marijuana to qualifying patients in New Jersey and that demand could change dramatically and patient's numbers could increase due to improved access to safe, high quality medical cannabis. FH intends to be prepared to meet fluctuations in patient load and product demand in order to ensure sufficient supply of medical cannabis to qualifying patients in New Jersey. Inventory control helps to implement FH ATC's primary mission - to provide a steady supply of high quality medical marijuana to registered qualifying patients, and also provide full transparency for the inspection audits. 1) ATC is authorized to possess two ounces of usable medical marijuana per registered qualifying patient plus an additional supply, not to exceed the amount needed to enable the ATC 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) 3-5. 2) During the first 60 days after commencement of operations, ATC is authorized to possess a reasonable supply of usable marijuana to build initial inventory, without the ATC having been designed for use by any registered qualifying patients or primary caregivers. 3) When there is a decrease in the number of registered qualifying patients and primary caregivers who have designated the ATC as their dispensary, the ATC shall have 10 business days to adjust the inventory. FH ATC will instruct each patient to fill out self-assessment records, which will help us to understand what strain and strength of cannabis works and what does not, and create the best combination of strength and dosage, that is most appropriate and effective for this patient's disease and condition. Using the weekly periodical reviews and information from NJHSS about registered patients in Northern Jersey, FH ATC would adjust its growing, dispensing capabilities and the quality of medicine. We would use Sea of Green (SOG) technology and growing in tiers, if necessary, increasing weekly growing and growing steadily to provide steady adequate supply of medical marijuana to our future registered patients. At the same time we can decrease our inventory in 10 business days if we experience a temporary decrease in the number of patients. Our future product will meet the standards of modern medicine: quality, safety and efficacy. The standards and procedures by which FH ATC determines the price it charges for usable marijuana.
The plan of FH ATC is to reduce the overall cost of dispensed medical marijuana and make a sliding fee- scale for those who are in need, thus reaching our ultimate goal to provide all registered patients with safe and constant access to medical marijuana for affordable price. FH ATC pricing will be stable, consistent and well below typical black market price. At the same Page 26 of 85
time, the price for medical marijuana must not be only reasonable, but also close to illegal black market prices in our region, which will help to eliminate illegal resale and diversion of medical marijuana. FH has a serious concern about MMJ diversion, and appropriate pricing is a safeguard against diversion as reported from other states with MMP. We are expecting to have the price for medical marijuana $250-350 per ounce, (twice as less as black-market price) depending on cannabis strength for the first year of operation, with subsequent lowering of it on the second year and further as our start-up costs decline and sales grow. Lowering the price at the second year canterminally not only offer discounts, eventodonate medicine to qualified patients in need(we For ill, having two but months live and to Veterans) .Theregistered price assumption is made only after consulting with Greenway University, GrowSetUp, Inc. and other industry specialists from different states. At the same time, maintaining retail prices at this level requires from FH ATC to add value to the licensed medicine through the increased quality and regularity. FH ATC should adhere to strict guidelines requiring organic production techniques. Medicine for retail would be inspected and graded, as well as tested. The packaging would be designed to prevent damage and degradation of the product, labeling would be consistent and uniform, and approved by NJHSS. Our Business Plan is detailing how the proposed ATC will operate on a long term basis as a nonprofit organization. FH ATC will be a Medical Model Business with a patient-oriented strategy, and at the same time one of our future major expenses is a comprehensive security system. FH will be spending more than half a million of the build-out budget on security technology, provided by ADT company, except additional expenses for other security measures, in order to ensure the safety and security of employees, patients, and caregivers. For the first ramp-year FH ATC is going to lease the security system with option to buy. On the second year of operations, FH is expecting to purchase it. FH ATC will have a "state of art" security ADT system. We will be employing biometric fingerprint locks on all access points to the facility. There will be a separate access to the vault and growing facility, to ensure the limited access to a critical area. All inside and outside areas of the building: offices, dispensary, cultivation, and entrance will be monitored by 24/7 surveillance rotating 360 degrees security megapixel cameras. Activity will be recorded on a DVR unit, and will be monitored by FH monitoring specialist and by ADT monitoring specialists. The outside part of the building will be lit with a combination of flood lights and motion sensor lights and megapixel day/night rotating security cameras. The dispensary area space will be accessed by patients using man-trap entrance with a security guard verifying patient's identity before allowing the entry inside. The security guard will be equipped with a metal detector. All staff members will be outfitted with silent code panic buttons, or will be within a reasonable distance to a panic button. The burglar, panic, and fire alarms (silent) will all be tied together and connected to alarm monitoring by ADT. All security systems and computer systems will be protected via a battery backup system, which will be tied to a generator in the event of electricity outages. FH ATC business plan shows the high increase in insurance premiums every following year. This is explained by the reason that the price of cannabis crop insurance is the most expensive part of the whole insurance package. Anticipating that we would have to increase our growing Page 27 of 85
production in many times due to the projected number of patients on the second year, we have a big increase in the crop insurance premiums and thus a very high cost of the whole insurance package. FH ATC future income, depending on projected number of patients, shows an excellent progression from loss situation in the first ramp year (when our expenses exceed revenues) to solid profits within next two years. As soon as allocate excess funds FH ATC estimates that the greater part our future revenues go towards FH Charitable program and we would do a solid capital investment for the facilitywill improvement. The excess revenue would never ever benefit any officer, employee or manager from FH ATC.
Total labor and other expenses climb proportionally to the projected number of registered patients. FH ATC will hire employees as soon as it will be awarded the permit. At the beginning of operations some of the employee functions will be accomplished by the same individuals with a minimum number of employees. Full benefits would be offered for every FH ATC staff member. Our staffing plan is based on projected registered patients needs and is fully and quickly scalable to meet the increasing demand. A statement of required qualifications and position descriptions is included in Appendix F. We will continue retain the services of Growing consultants from California and Nevada, paying for their living accommodations, Legal consultants and Accounting and business management consultants. FH projected capital requirement will sufficiently cover all our start up expenses and operating expenses and we will have additional capital remaining available if needed until FH ATC becomes self-sustaining. FH ATC future expenses start- up expenses include, but not limited: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.
Consulting services; License; Construction of the ATC facility together with Growing Set Up facility Payroll/Staff, payroll taxes and benefits; health insurance Rent and utilities; Office Supplies/Product costs (mainly for growing facility); Inventory control system and POS Telephone/Internet/Mail; Software monthly services by Proteus420; Packaging and labeling;( digital scales, pharmaceutical jars, special packaging tables) Insurance; Security system; ( master security alarm, fire alarm, monitoring cameras, badge echnology) Contractual monthly services by ADT Security; Page 28 of 85
14. 15. 16. 17. 18. 19.
Legal and accounting services; Office expenses; Furniture Consulting growing services including their living accommodation; Loan repayment with interest; Growing organic, (all necessary equipment, trimming machines, magnifying microscopes, testing kits). Future lab equipment.
20. of educational brochures and materials; 21. Developing Repairs, maintenance, miscellaneous. 22. Taxes FH ATC will borrow the funds, required to set up and begin operations from which opens a credit line of three million dollars with 8% interest rate. The startup capital will be held on escrow account for the benefit of FH ATC. The funding will be liquid and immediately available if FH is awarded a license to be ATC in Northern NJ. FH ATC debt and its repayment will be structured so that it is flexible, have no prepayment penalties and allows a gradual draw-down of the principal. Repayment schedules start when FH ATC achieves certain financial benchmarks. In the future the loan may be partially or wholly prepaid with no penalties. II. The applicant shall provide a copy of its proposed policy regarding charity care/servicing indigent patients. Response:
1) FH will operate as a non-profit organization. As such, it will allocate a greater part of its net revenues (surpluses), helping those registered patients, who cannot afford either all or part of their medicine. FH will allocate a special amount of funding each year to fund its discount program. Discount will be based on the patient's application of economic need (defined by income) and will enable all eligible members to receive the medical marijuana and paraphernalia they need. Understanding our patient's health and socio-economic status is the most rewarding and important part of FH ATC work. FH ATC is projecting the cost of medicine to be $250-350 depending on the strength of medicine (low, medium or high). We want to provide medical marijuana as a therapeutic option to all patients with debilitating medical conditions, including those who may not be able to afford treatment. FH is going to develop a sliding fee scale, based on income, for those cannot afford the medicine. We will provide terminally ill patients with a less than 2-month life expectancy with free medication if allowed by Health Department. For those who are financially challenged there will be four tiers of pricing: Tier I - 10% discount price; Tier II - 20% discount price; Tier III - 25% discount price;
Page 29 of 85
Tier IV - Free (for terminally ill patients with a less than 2-month life expectancy and Veterans). To be eligible for this assistance program, the patient has to: Be a registered qualifying patient and have a valid state issued registry identification card from the New Jersey Department of Health; Provide proof of income within assistance program guidelines; demonstrate eligibility under the New Jersey Medicaid program, receipt of current food stamp benefits, receipt of current New Jersey Disability Insurance benefits, Supplemental Security Income benefits or Social disability benefits. Registered qualifying patients must complete an enrollment form and submit it to FH ATC. FH future ATC will have a Medicine Discount Program for the patients who are eligible and in need.
Elizabeth H. Sonnenthal, future FH ATC Social Worker will open the cases, orient the patient's about the program and report to the Board of Directors about registered patients' eligibility for the sliding fee-scale program. FH will not only be a source of medical marijuana, but a source of social support for the community, which is one of the most rewarding aspects of our future work. 2) holistic approach to disease management, wherethat the patients focus is can't not only marijuana butAalso on adjunct medical services and therapies, pay on by medical themselves or are not covered by their insurances, would be provided by FH ATC as a charitable program. FH ATC will offer referrals, complimentary and reduced fee holistic services partnering with professional services in the area: Foundation Harmony has the engagement letter from Self-Awareness and Transformation Center, located at 126 Park Ave, E. Rutherford, NJ, 07073 about offering free (once a week) professional services like, yoga, sound and color healing therapy, energy healing, acupuncture, meditation techniques for registered patients of ATC , referred to them by FH Board of Directors. For this purpose we will allocate a portion of our future revenues. Foundation Harmony has the engagement letter from Tri State Health and Wellness Medical Center, located at 31-00 Broadway, Fair Lawn, NJ 07401. This medical center is going to provide professional services: Acupuncture, Massage Therapy, Physical Therapy, Vitamin and Mineral Supplementation through Intervenal Infusion, Drug, Alcohol and other Controlled Dangerous Substances Abuse Treatment, Pain Management and Hypnosis for registered qualifying patients of Foundation Harmony ATC. FH will pay for these services from it's future revenues (by the Board of Directors decision), if such services are not covered by registered FH ATC patients' insurances and by decision made by FH ATC Board of Directors. Foundation Harmony has the engagement letter from Dr. Shtillman,DDS from CavityFree Dental Care, that he would provide professional dental services to "special need" patients, referred to him by FH ATC. FH ATC will cover the dental treatment cost for such patients in Hackensack Hospital facility if some of these services are not covered by their insurances ( as anesthesia), by the decision made by the Board of Directors. Page 30 of 85
FH will continue to partner with other medical offices in the area to provide the Holistic approach to the treatment of our future registered patients to promote their healthy lifestyle. 3) FH Board of Directors is determined to educate our community, especially young people to stay away from drug abuse and drug activities. For this purpose we will allocate a part of our future revenues to pay for the services of special Substance Abuse Counselors, working on specific programs, providing:
Through on-site school counseling; Providing therapy to teens recovering in a residential treatment center; Holding one-on-one counseling sessions with youth recovering from drug or alcohol abuse.
4) FH would invite medical counselors, doctors and other experts in medical marijuana industry to educate interested parties of the community about medical marijuana and all aspects in this field. FH ATC Social Workers will consult registered patients and their primary caregivers about FH charity program and possibilities to help them in different problems arising in their lives and the lives of the members of their families. Social Worker would report to the FH Board of Directors to help resolve such problems as: grieving, funeral, adjunct medical services mentioned above. Appendix G: Operation Manual: Patient Assistance Program Application (sample), p. 28. Appendix I: Engagement Letters from medical offices.
NOTE: FOR OFFICIAL USE ONLY, LIMITED FOR PUBLIC REVIEW, CONTAINING CONFIDENTIALITY AND PROPRIETARY INTELLECTUAL PROPERTY. III. The applicant shall provide a copy of its proposed policy related to disposal of returned or unusable marijuana. Response:
The disposal of unusable or returned medicine requires a detailed policy, documentation and supervision. Destruction of medical marijuana by FH ATC will be done in such cases: 1) Contaminated marijuana; Infected and contaminated marijuana should be packed in special containers and quarantined in the Contamination Room immediately. 2) Unused marijuana or surplus inventory, if the actual number of patients is less than the projected number, thus, there is a surplus of grown and packaged medical marijuana in the facility; Page 31 of 85
In this case FH ATC has to destroy its surplus within 10 (ten) business days. 3) If the permit to operate an ATC expires without being renewed or is revoked; Within 10 (ten) business days after destroying the marijuana, the ATC has to notify NJHSS, in writing, of the amount of marijuana destroyed. 4) If a qualified caregiver shall medical marijuana that is no longer needed for himpatient/primary or he/she was disqualified as adispose registered patient by FH and NJHSS; FH ATC Executive Director shall check if this medicine was received in FH ATC and provide the patient/primary caregiver with a record, showing the name, date and the amount of medical marijuana returned to the dispensary. This medical marijuana should be destroyed. 5) If FH ATC requests the return of accidentally sold contaminated medical marijuana. (using bar code system: each strain, batch, lot and prepared packages will have a bar code, and thus FH ATC can keep track of medicine sold) The return request should be done as soon as such accident is discovered. (FH ATC quality control system and Plant Cultivation sanitary system would prevent our patients from such accidents) FH ATC checks if this medicine was sold by FH and prepares a replacement. All this information should be recorded in patient's records and FH inventory and disposal records. 6) There can be 2 occasions for return of medical marijuana by FH ATC patients, when FH ATC does not make any replacements: a) If the patient/primary caregiver returns medical marijuana which is defected because of improper storing; Executive Director, while checking if medical marijuana is from FH ATC, would notice that improper storing caused defected marijuana. There will be no replacement from FH ATC. The record should be made, showing the name, date and the amount of medical marijuana returned to the dispensary. This amount of defected medicine should be totaled in the whole record of marijuana identified for destruction. b) If the patient/primary caregiver returns marijuana, which was not produced and purchased in FH ATC. Executive Director, noticing this, should notify the patient that FH ATC immediately disqualifies him/her from the list of registered patients, and immediately report to NJHSS and local law enforcement agency. This package should be stored separately, until local law enforcement agents could visit FH ATC.
Page 32 of 85
FH ATC registered patients/primary caregivers have to receive FH ATC Return Policy on their first visit and o be informed, that they have to make a prior appointment (by phone) to return unused, unadulterated or contaminated marijuana. The person, submitting marijuana for disposal shall present a valid registration ID card and NJ Driver license or other valid NJ photo ID card. FH ATC will have a special contamination room in the Plant Cultivation facility with special containers to hold unusable, contaminated or unadulterated medical marijuana. Marijuana for disposal stored in compliance 21CFR 1301.72. FH ATCwill will be have the agreement withwith NJ State Police to schedule special days to collect medical marijuana identified for disposal. FH ATC will provide security for law enforcement officers while collecting medical marijuana for destruction on its site. All medical marijuana prepared for disposal should be weighted and inventoried prior to destruction. Executive Director is responsible for the Disposal Procedures; he/she and the law enforcement officer would sign a special Disposal Record. This record will contain: name of the dispensary, name of the Executive Director or other person responsible for disposal, date of disposal (pick-up date for disposal by the Police), and method of disposal. The copy of this Disposal Record would be given to the law enforcement officer at the time of pick up. There will be a special Inventory page in the FH ATC POS software, registering all disposal activity. The disposable records have to be kept at least 2 years. IV. The applicant shall complete the following projected income statements for the first three (3) years of operation. Round all amounts to the nearest dollar. Response:
FIRST_FULL FISCAL_YEAR
SECOND_FULL FISCAL_YEAR
2012 Jan-Dec
2013 Jan-Dec
$250 per oz
$250 per oz
$250 per oz
Medical marijuana sales to $2,300.000 qualifying registered
$16,850.000
$29,325.000
Other supplies sold to $15.000 registered qualifying patients
$50.000
$50.000
Other revenue (identify):
N/A
N/A
RAMP UP YEAR 2011 Jul-Dec REVENUE:
sources N/A
TOTAL REVENUE:
$2,315.000
$16,900.000
$29,375.000
EXPENSES:
$3,686.060
$7,776.310
$10,840.410
Payroll w/Fringe ( 7%)
$1,025.060
$2,175.310
$2,742.410 Page 33 of 85
Medical marijuana growing
$162.000
$592.000
$1,030.000
Medical marijuana testing
$20.000
$500.000
$ 50.000
Medical marijuana packaging and labeling
$36.000
$270.000
$469.000
Construction
$1,900.000
$2,400.000
$2,600.000
License Fee
$20.000
$20.000
$20.000
Technology
$95.000
$75.000
$75.000
Call Center
$24.000
$24.000
$18.000
Security
$136.000
$600.000
$50.000
(8 months) Supplies
$8.000
$15.000
$20.000
Office Expenses
$65.000
$20.000
$30.000
Utilities
$60.000
$150.000
$290.000
Insurance
$75.000
$305.000
$485.000
Interest
$120.000
$240.000
N/A
Loan Repayment
N/A
N/A
$2,300.000
Depreciation/Amortization N/A
$390.000
$661.000
Leasehold Expenses
$525.000
$700.000
$700.000
$400.000
$320.000
$250.000
$4,611.060
$8,796.310
$11,790.410
-$2,296,060
$8,103.690
$17,584.590
Number of Patients:
1500
4000
4600
Number of Visits:
9,200
67,400
117,300
Bad Debt Consulting/Retainer TOTAL EXPENSES: Difference:
Page 34 of 85
1) This table does not contain a section about FH ATC's future taxes, which would be a significant part of FH ATC future expenses. 2) On the second full fiscal year 2013, when FH ATC intends to finish the testing laboratory project, the expenses for testing would be: consulting services of our chemist Steven D. Castellano, the consulting services of SteepHill Laboratory from California and laboratory equipment. 3) On the second full fiscal year 2013, when FH ATC already has its own security system bought from ADT in 2012, our expenses for security would be comprised from monthly maintenance payments to ADT, U.S. Security Associates, Inc. for Tour-Positive Security System, and software provider Proteus420. 4) This table does not contain FH ATC future expenses for employees' health insurance and other benefits. 5) This table does not contain FH ATC future expenses on charitable program and sliding fee scale. 6) Construction expenses include FH ATC expenses for Set Up of the Plant Cultivation facility. 7) FH ATC intends to repay the loan on the second full year 2013.
PERSONNEL CATEGORY
RAMP UP YEAR
FIRST_FULL
2011 Jul-Dec
FISCAL_YEAR Jan-Dec
SECOND_FULL 2012 FISCAL_YEAR Jan-Dec
2013
# OF FTE #4
PAYROLL # OF W/FRINGES FTE
PAYROLL W/FRINGES
# OF FTE
PAYROLL W/FRINGES
$420.000
#4
$420.000
#4
$420.000
#2
$45.000
#2
$90.000
#2
$120.000
#2
$30.000
#4
$120.000
#8
$240.000
Patient Service #2 Specialist Social Worker #1
$30.000
#4
$140.000
#8
$280.000
$25.000
#2
$100.000
#2
$120.000
Chief Security
#1
$38.000
#1
$75.000
#1
$75.000
Security Guard
#4
$192.000
#8
$384.000
#8
$384.000
Board Administration Shift manager Receptionist
(8 months)
Page 35 of 85
System Administrator Electrician
#2
$50.000
#2
$100.000
#2
$120.000
#1
$25.000
#1
$50.000
#1
$50.000
Handyman
#1
$20.000
#1
$40.000
#1
$40.000
Cleaning Service
#1
$11.000
#2
$44.000
#2
$44.000
Consultant
#1
$100.000
#1
$120.000
Consultant
#2
$100,000
#4
$200,000
Plant Cultivation Manager Growers Training Growers
#2
$35.000
#4
$140,000
#4
$140,000
Food Handler
#1
$12.000
#1
$30.000
#2
$60.000
Packaging
#2
$25.000
#4
$100.000
#6
$150.000
#26
$958.000
#43
$2,033.000
#54
$2,563.000
TOTAL:
FH ATC will pay on a monthly basis for the consulting services of: 1) Legal services: Sills Cummis&Gross P.C., Gary Hershman, Esq. and A. Ross Pearlson, Esq. Address: One Riverfront Plaza, Newark, NJ 07102-5400 (Phone: 973-643-7000) 2) Growing services: GrowSetUp Company from California and Nick Tarantino from Nevada. 3) Science and analitical chemical consultations and a lab project management: Steven D. Castellano (541)382-6065 from Oregon. ( as soon as we need his consulting services) 4) CPA. for preparing payrolls and income taxes. Marketing and advertising strategies are critical to build our business and create the revenues necessary to start-up, ramp up and sustain business. However, marketing and advertising will not be traditional for the most part and will instead take a form of "awareness program". Our strategy is networking with registered in MMP doctors, our Medical Advisory Board, hospitals, affiliated with FH ATC, and also through establishing a link with registered qualified patients through NJ Health Department, the community, and local organizations that deal with terminally or chronically ill people. Measure 3: The applicant shall document its experience running a not for-profit organization or other business (es). [WEIGHTED REQUIREMENT up to 5 Points] Response:
Page 36 of 85
The Board of Directors and General Managers of future FH ATC have the necessary business experience running non-profit organizations and profitable businesses. Their combined knowledge is the most important key for successful FH ATC operations. Marina Karavas, Executive Director
Mrs. Marina Karavas has dedicated her life to community services and has been serving the people of New Jersey since 1996. Marina’s community service began at the age of 19 when she lost her mother to cancer in Russia.
Her personal experience and loss of both her parents at a young age resulted in her eventual career path. In 1996 she began helping the elderly as well as invalids and low income families in the United States and continues to do so on the voluntarily basis. Her volunteer work is very much appreciated by the Northern New Jersey community, especially in Bergen County. From the year of 2000 and until 2009 she was a President of company, providing corporate filing, translations, power of attorney for overseas use in Russian and Ukrainian, worked with attorneys (Sergey Orel, Esq; countries' Sonya Bromberg, Esq). It wasworked a good with time New to share the Department knowledge and experience with foreign immigrants. Marina Jersey of Treasury, NYS Department of State, Cliffside Park Welfare Office, Bergen County SS Office, Asylum Office, GLBT Center, Valley Hospital Clinic and many other offices and departments serving NJ residents. Back in Russia, through hard community work she was admitted to the school of law in Moscow. After her daughter’s graduation from Berkley College in N.J., Marina decided to continue her studies of law in the U.S. She applied at Benjamin N. Cardozo School of Law and studied there. Unfortunately Marina could not complete full course of education due to her close friend’s (Marina Averbukh's) cancer, and she postponed her education to the better times. Marina voluntarily helped and took care of this young woman who was diagnosed with thyroid cancer and had several complicated surgeries. Through two of the most difficult years of Mrs. Marina Averbukh's life Marina Karavas was helping and accompanying her personally to the Welfare and Social Security Offices, Doctor’s offices, interpreting over the phone and in person (Mrs. Averbukh could not talk after the surgery) and providing other personal, day to day activities' help. Marina Karavas personal experience in life brought her to medical marijuana industry. In 2008 she became the Executive Officer of Foundation Harmony. Together with Foundation Harmony CFO, Ida Umanskaya, Marina started research on cannabis in the other states where the legal medical marijuana was already permitted. On behalf of Foundation Harmony she talked to patients over the phone and did her own research on the Internet. Her personal communication with registered patients in Colorado showed Marina that Page 37 of 85
cannabis eases the suffering of cancer patients, help chemo therapy patients to feel better during this treatment, get appetite and even survive. In June 2010, Marina Karavas and Ida Umanskaya together with Greenway University, the first in the US University that was accredited by Colorado Education Department for MMJ education, organized Medical Marijuana Seminar in New Jersey. It attracted a great interest from different people from NJ community. After the seminar, Marina and Ida decided to see the industry in person and took a trip to Denver Colorado. They visited master growers and testing laboratory, talked to caregivers and owners of the dispensaries as well as to MMJ patients. Later Marina took a trip to Nevada to see private patient's growing. The Compassionate Act in New Jersey has provided a fresh outlet for Marina’s passion to assist those who are sick and suffering. She decided to use her full set of management skills, a proven record of accomplishment, and commitment to the welfare of New Jersey registered patients in MMP. Marina Karavas is devoted to the creation of New Jersey first Medical Model Alternative Treatment Center and hopes that Foundation Harmony would receive the license to operate it. She can bring her passion and enthusiasm to the leadership of FH ATC. Marina lives with her husband and daughter in Cliffside Park, New Jersey. Ida Umanskaya, Director of Holistic and Social Operations
Ida Umanskaya is a resident of New Jersey for the last 18 years. She emigrated with her daughter from Russia, having a status of refugee. She came here with her daughter, being a single mother. Ida Umanskaya was born in the family of the physicians, and wanted to be a Doctor from her childhood. But due to anti-Semitic policy of Soviet government especially in Leningrad, she didn't have the possibility to be accepted to Medical University. She graduated from the University of Precise Mechanics and Optics, MS equivalent in Optical engineering and design, but her passion to work in medicine was very strong and she became a student of St. Petersburg School for Preparation and Improvement of Qualification of Nurses. Coming to USA she began to study Health Sciences and Health Management on the first year of her living here. She graduated from New York Touro College, getting Bachelor of Health Sciences and Health Information Management in 1995. She worked in various medical offices in New York and New Jersey as a general manager. She saw a lot of patients suffering from cancer and chemotherapy coming to these offices. Two of Ida's close friends died from brain cancer not even reaching 50. Ten years ago her mother was diagnosed with chronic leukemia. Ida understood that she wants to study alternative medicine and in 2007 she started studying in Clayton College of Natural Health ,Naturopathic Doctorate degree ( pending, because this private institution was closed in 2010), where she studied courses: Herbology, Iridology, Homeopathy, Cancer Prevention, Detoxification and Healing, Naturopathy, Fundamentals of Nutrition and Dietary Influences on Diseases. In 2001 her daughter graduated from Bergen Academy,( medical course) and entered Wesleyan University for Premed program. In 2007 her Page 38 of 85
daughter Karina Umanskaya started studying in UMDNJ after working on oncology research for 2 years in Mount Sinai Hospital, NY. The pride of her mother, Karina was among of the authors of the article about the genes that ovexpressed in breast cancer which was published in 2007 in " The Journal of Molecular and Cellular Biology". This year (2011) Karina is successfully finishing the fourth course of studying and goes for residency. Ida's daughter promised to voluntarily work for Foundation Harmony Medical Advisory Board after finishing her studies. In 2007 Ida and her twin sister were diagnosed at the same time with melanoma on early stages. Ida's daughter and niece were founded suspicious moles which could be possibly developed in melanoma. Studying in CCNH, Ida understood that there could be other factors than sun and genetics, causing melanoma. Ida thought that some skin care ingredients in creams and lotions could possibly play a crucial role in skin cancer development. She decided to develop her own skincare line which will not only have anti-aging benefits but would be free of parabens and other possible damaging ingredients. Her skincare line was very professionally formulated in France and in Beilis Development laboratory in New Jersey. One of the most famous NY dermatologists Dr. Joel Kasimir was buying nearly the whole production for his prestigious clientele during 3 years (Until 2010). Ida also formulated a supplement for the best skin care. (See "' DAY SPA" magazine article in Appendix) When studying Holistic health approach in CCNH, Ida and her partner Marina Karavas cofounded non-profit organization Foundation Harmony in 2008, deciding to help NJ state in educating general public and interested parties in medical marijuana industry. They contacted Greenway University, the first and only in the nation accredited Medical Marijuana University, to provide a seminar in NJ. It was successfully held on June 5, 6 2010. Ida and Marina developed a website www.harmonyfoundationmmjnj.com in the form of electronic library educating NJ community about medical marijuana industry in different states, medical marijuana benefits for some of debilitating conditions, showing some possible adverse effects of cannabis use, and explaining NJ Act and NJHSS rules and regulations in MMP. According to Google monthly information our site is visited monthly more than 500-700 times, and today when the implementation of the program is very close, Foundation Harmony has enormous volume of phone calls and visits by potential patients and even by Doctors who want to be consulted in medical marijuana program in NJ. Visiting numerous Colorado and California grow rooms and dispensaries and also a Compassionate Center in Israel, Ida and Marina Karavas decided to develop FH ATC and file the application to be one of ATC permitted in Northern NJ. They applaud the Medical Model of NJ MMP and want to build a professional and compassionate ATC which will provide NJ registered patients with safe access to steady and highest quality supply of medicine. They also developed the proposal for future charitable community program. After visiting numerous dispensaries, Ida understood that lotions and tinctures infused with cannabis are made unprofessionally and could sometimes cause more disadvantages than bring benefits. In 2010 Ida patented her idea for a "Dual-chamber packaging for cannabis infused products" (patent number: 8092761.). The packaging consists of 2 double wall vials, allowing to fill one of the vials with safe and professionally produced formulation, developed in Beilis Page 39 of 85
Development laboratory (FDA registered), while other vial will be filled with cannabis oil in the dispensary. The professionally made formulation will not only increase the transdermal delivery of cannabinoids through the skin, but will have additional benefits: instant pain relief, antiinflammatory and anti-oxidation benefits, due to the well known properties of natural ingredients in the future formulation. The future product with trademark Immunik (85124813) is now tested in California, where this process can be done legally. This product can be produced by FDA registered facility, professionally and safe, and in large quantities, thus bringing invaluable benefits for and the chemists health ofnoticed registered in all states with Beilis Development pharmacists that patients NJ medical marijuana rules MMP. and regulations are allowing using DSMO in producing Topical lotion, while DSMO has the alert guidance by FDA, having restrictions of using for patients. At present, the only human use for which DSMO has been approved is for interstitial cystitis (bladder condition). FDA also mentions that the industrial grade product which is the only DSMO sold in USA is not for medical and drug purposes and is not made under safe conditions for the protection of all users (not only patients but their caregivers too). There can be unexpected and serious side effects ( for the patients, primary caregivers and even ATC employees working with DSMO), because DSMO, being the great "carrier" could easily deliver harmful (even poisonous) substances into the bloodstream and there has to be a special quality of plastic (high density propylene) for packaging and special precautions while producing a lotion. There is a great possibility, that there is no any future ATC, which knows and can assure the necessary safety conditions. Ida Umanskaya dedicated a lot of time writing the application according to NJHSS rules and regulations and especially to the holistic part of the program, developing self-assessment records and educational materials. If FH gets a license to become ATC, Ida Umanskaya will work in collaboration with FH Medical Advisory board to assure that FH ATC meets Medical Model criterion and to ensure that FH registered patients receive the best quality product in the consistency of dose: great education in different safe techniques of using cannabis, excellent quality paraphernalia and achieve the highest positive outcomes in their health. She also received the engagement letters from several medical officers in Northern NJ area, to provide adjunct health services not covered by Medicaid, Medicare or other insurances to FH ATC registered patients, improving their health and providing them with charitable health care, to ensure that such combination of therapies with the right medical marijuana product will bring effective clinical outcomes. She also suggested that future FH ATC must have social workers among its staff who can be approached by FH ATC registered patients with their questions about the sliding fee scale, charitable health care and other segments of life, where FH ATC can help them and decrease their emotional stress, enhancing their quality of life. Thus FH ATC can be not only a Medical Model ATC, but a community oriented Medical Model. Ida will also work on the future development of a laboratory on the facility premises to scientifically test the cannabinoid levels of the cultivars grown in the facility and helping provide the consistency of potency and purity of medicine, while preventing contamination of cannabis. Ida can bring unique passionate and enthusiastic Holistic approach to managing future FH ATC. Margarita Ivanova, Director of Administrations and Finance
Page 40 of 85
After graduating High School in the summer of 2000, Margarita Ivanova moved to New Jersey from New York and chose to attend Berkeley College to pursue a career in Finance Management. While earning a Bachelor’s degree between 2001 and 2005 she worked as an executive assistant for Corporate Club USA. From 2002 to 2003 she assisted the company president Marina Karavas with everyday activities: handled accounts receivable, accounts payable, and billing, she also handled bank deposits and bank reconciliations. Margarita learned the process of filing corporations with the Department of State. In the summer of 2003 Margarita learned about a position opening in Cliffside Park Imaging for a front desk assistant. She saw an opportunity to work in an environment where she can help people and get her foot into the medical field. Margarita always enjoyed helping people out and by taking this job I’d be able to assist sick or injured patients. She learned everything quite fast and was able to move up in the company and become the office supervisor. In 2005 Margarita graduated from Berkeley College and decided to remain in the medical field because of the pleasure she received from helping patients. Making a difference in someone’s life and making sure he/she is being treated with care and courtesy made her appreciate working in the medical field even more. Not only was she helping patients but she was learning theapply business of the radiology HerAeducation came in very and, also she was able to what side she learned in collegefield. at work. typical day included herhandy, many assignments and responsibilities. She supervised the patient admission process and made sure patients were taken care of appropriately. She verified patient eligibility and obtained authorization from their insurance companies for the procedures they were coming in to do. Working side by side with as many as four radiologists at a time, Margarita had to assist them and make sure they had all the required information to be able to diagnose the patients accurately. Her other responsibilities included handling financial transactions, recordkeeping, and payroll. Reconciling, evaluating, and resolving collection accounts. Creating invoices and monitoring overdue accounts. Supervising medical billing and coding. She had to make sure procedures were being diagnosed and billed correctly. In 2007 Margarita was presented with a new and exciting project. She was asked to supervise a brand new facility, Ironbound MRI, and assemble a team of employees that she would then have to train for their positions. Margarita successfully put together a wonderful organization and was able to pass her knowledge and passion to a team of people striving to obtain a position in the medical field. She felt it was very important to have a group of individuals who were caring and desired to make a difference in people’s lives the same way I did. I’m glad I was given an opportunity to build from scratch and learn the process of starting a new company. Most importantly, doing it the right way and making sure the people are chosen to work in such a delicate environment. Margarita knows that people want to be treated with care right especially if they are very sick or just recently got into an accident or got injured. She
Page 41 of 85
managed to set up an environment where patients felt comfortable and were pleased with the way their appointment went. Today Margarita is working in Cliffside Park Imaging and Diagnostic Center and in Ironbound MRI in Newark as The Office supervisor and Financial Specialist. Margarita spends a lot of time with her mother Marina Karavas and respects her very much. Rita decided to work in Foundation Harmony ATC to pursue her carrier in medical field. She is very much interested in setting up a real Medical Model of the Facility and to be a part of this new and rewarding environment. Rita can bring her young energy and enthusiasm, her expertise and skills in medical office management, willingness to hard work to FH ATC. Dmitri Bajanov, Director of Operations
Dmitri Bajanov was born to become a great enterpreneur. After graduating from Gorkovsky MilitaryUniversity with MS in business administration and finances, ( civil specialty), Dmitri became the Chief Manager with responsibility for technical, food and other necessary provision of seventy commercial ships and shore warehouses. He was in his early twenties at that time. This fact shows the unique talent of Dmitri in managerial field! Coming to USA in 1992 he continued his entrepreneurial work, opening one medical clinic with a group of seven doctors in New York, Brooklyn. Today, Dmitri Bajanov is the President of NGU Omega Management Inc, owning and providing management for two medical clinics in Manhattan and Brooklyn with 30 health professionals working in them. Dmitri Bajanov has a professional experience with privately-held medical businesses and has excellent communication skills associating with doctors and other health care professionals. Working as a Manager of medical clinics, Mr. Bajhanov is extremely knowledgeable in the medical industry business: in rules and regulations regarding patient's confidentiality, medical records safety, reporting to health department, planning, recruiting ,coordination of services, managing finances, in provision of medical and other office equipment, software and supply provision and oversight of medical clinics. His previous experience and background from Russia (working for naval supply on a large scale), is of great value for developing the business and security plan for FH ATC in detail and in the whole. He will be the invaluable asset to FH ATC operations and oversight! His company NGU Omega management Inc is providing FH with a sufficient capital crediting line on very favorable conditions. Mr. Bajanov can bring the outstanding entrepreneurial and medical business management expertise to the future FH ATC. He will be a linchpin for FH ATC operations. Mr. Bajanov resides in Edgewater, NJ with his wife and two sons. Appendix J: Letters of support Criterion 3: Community Input -Describe the ATC planning process and involvement of Page 42 of 85
Community's stakeholders in detail. Describe remaining steps if any to receive necessary approval for site location or operations. [TOTAL WEIGHTED REQUIREMENTS up to 30 Points]
FH ATC is dedicated to become a union with Secaucus and Northern NJ community by demonstrating respect, courtesy and compassion and ever-present willingness to promote tenacious between registered patients,anprimary caregivers, community groups andatmosphere other interested associations. FHqualifying strives to develop environment built upon dignity and mutual respect for every individual in the community, while remaining acceptable to FH ATC future registered patients to whom we choose to work. At all times we will provide a high level of service consistent with patients' and public expectations. FH will develop an enhanced quality- of- life of our future registered patients through community partnership, involving those who are interested. FH Directors choose to go extra miles to provide special services with personal touch. FH ATC's mission- the secure cultivation and distribution of organic medical marijuana to qualified registered patients. FH takes the conception to coordinate a balance between its operations and economic vitality and environmental preservation of the community. While talking with our future security guards from U.S. Security Associates Inc, we got to know that Mr. Marini's father has a fourth stage of colon cancer, and Mr. Graulich mother has a fourth stage could be our is possible registered patients. FH are not awareofoflung any cancer. family Their in theparents community, where no at least one member, whoofficers is not having cancer and is suffering from severe pain. It is a very sad fact, but it is a reality. Implementing our mission, FH ATC is going to serve Northern Jersey Community - rendering compassionate help to suffering people! Our motto is:" Help is in the Compassion". FH ATC will be developed as a Medical Model facility, which will provide registered patients and their primary caregivers with current, scientifically accurate information about medical marijuana and the ability to participate in ongoing systematic collection of data on the benefits and/ or unintended consequences of medical marijuana use. The data would be collected, organized and shared with patients, caregivers, prospective patients, the medical community and the Department. 1) FH will install high quality comprehensive security and fire alarm system in the future facility, thus the community would be prevented from the increase of criminal activity. 2) FH will collaborate with local enforcement authorities on security and safety issues. 3) FH will work with local government, local police and community to ensure public safety and public well-fare. 4) FH will work with local building department to ensure that the facility construction is made close to code and zoning requirements. 5) FH will try to reduce energy consumption by using energy efficient modern equipment 6) FH will install the systems to eliminate possible odor and possible harm for the neighborhood environment 7) FH will give business to security, construction and other companies of the community, thus promoting the employment. FH will provide employment opportunities for people of different professions and qualifications.
Page 43 of 85
8) In the future, the surrounding area and community would see the increase in different kind of businesses as sales, food, services, because of the increased traffic of patients and their primary caregivers. FH ATC will also help revitalize the area around it, bringing traffic of new people. Even if registered patients are not immediately utilizing the local services or purchasing of goods offered by neighboring businesses, they are more likely to eventually patronize those businesses, because of convenience. 9) FH ATC will have a comprehensive charitable care program, which is written in detail in the special would be given to those agencies and non-profit agencies, that provideparagraph. services toFH FHATC ATCgrants registered patients. 10) FH Board of Directors is determined to educate local community, especially young people to stay away from drug abuse and drug activities. For this purpose we will allocate a part of our future revenues to pay for the services of special Substance Abuse Counselors, working on specific programs, providing: - Through on-site school counseling; - Providing therapy to teens recovering in a residential treatment center; - Holding one-on-one counseling sessions with youth recovering from drug or alcohol abuse. 11) FHoffer ATC would money to "Drug drug Rehab" and Integrity House located members. in Secaucus, which long termdonate therapeutic community treatment for young community 12) FH would invite medical counselors, doctors and other experts in medical marijuana industry to educate interested parties of the community about medical marijuana and all aspects in this field. ASA comprehensive survey of officials whose cities have dispensary operations found that the vast majority of businesses had no problems associated with dispensary operations working under State's rules and regulations. Our future level of ATC security system and surveillance will add up to a safer street environment and make areas around FH ATC one of the safest areas of the Northern Region of NJ. FH ATC will be also glad to create a community oversight committee with the Mayor at the head, which can lead us to better serving the community needs. FH ATC will be glad to seek feedback from the community regarding matters involving ATC. We will seek feedback from patients, employees, medical advisors, government officials and general community on key matters involving FH ATC. We can do open meetings, encouraging submission of feedback. Although FH ATC is a non-profit company, we can fulfill our charitable program only when our operations will generate a funding surplus. We will review FH ATC financial performance regularly to ensure that we can implement our charitable program. FH ATC would need the approval of Meadowlands Commission. Our real estate agent was assured by the Meadowlands Commission zoning engineer that if FH ATC is in compliance with zoning and codes, there can be no rejection from the commission, because a city has a lot of Page 44 of 85
substance controlled drug manufacturers in the area. Afterwards, there is a process of obtaining permits from building department, if FH ATC is awarded with the license. Measure 1: Input from the city(s) or town(s) where the applicant’s ATC would be located. [WEIGHTED REQUIREMENT up to 15 Points] Response:
FH ATC has a letter from Secaucus Municipal Government Center Construction Department, which was signed by Vincent Prieto, Construction / Zoning Official. The Mayor of Secaucus Michael Gonnelli and Town Administrator David Drumeler are aware of FH intent to build the ATC in Secaucus and have no objection to our proposal, since our location meets all necessary regulatory and zoning criteria as set forth in the law and by other authority having jurisdiction. Appendix C: Town of Secaucus, Construction Department Municipal Government Center letter from Vincent Prieto, Construction/Zoning Official, cc: Mayor -Michael Gonnelli, Town Administrator - David Drumeler. Measure 2: Input from the general public regarding the suitability of the applicant and the general standards for location(s) such as, distance from a school, daycare center or other child-oriented location; distance from a commercial shopping district, pharmacy; etc. [WEIGHTED REQUIREMENT up to 15 Points] Response:
FH ATC is located in a distance of more than 1000 feet from schools, daycare centers and other child-oriented locations. FH ATC has a fantastic access to public transportation. There are 11 bus lines such as: # 2 Secaucus-Jersey City; # 78 Secaucus-Newark # 85 Secaucus-Hoboken # 129/124 Secaucus-New York # 190 Paterson-New York (via Secaucus) # 320 Secaucus - North Bergen Park & Ride - New York # 772 Secaucus-New Milford - Provides service between Secaucus Junction NJ Transit rail station, Harmon Cove, and Central Business District (Plaza) in Secaucus and New Milford, Dumont, Bergenfield, Teaneck, Hackensack, South Hackensack, Little Ferry, Teterboro, Moonachie, and Carlstadt. # 972 Harmon Cove Shuttle #32 Nutley-New York (via Secaucus) - Serves Central Business District (Plaza) in Secaucus: Port Authority Bus Terminal in Manhattan; Lyndhurst, Nutley Secaucus Community Shuttle Bus - This town operated bus provides three peak period services in the morning and evening, with terminals in the North End at Koelle Blvd & Mill Ridge Road, and at the NJ Transit Secaucus Junction Rail Station. Page 45 of 85
EZ Ride Shuttle Bus - Harmon Meadow - Secaucus Junction Train Station Free service morning and evening rush hour service to and from Secaucus Junction Rail Station with 8 stops in Harmon Meadow and Mill Creek. Bus stops shown on map at bottom of linked page. The facility is located within 1 mile distance from NJ Transit train station. All major NJ highways provide easy and convenient driving access to the facility.
"A" on the map shows the location of the future FH ATC. Secaucus Police Department (Ph: (201) 330-2060) and Fire Department (Ph: (201) 330-2060) are located in a distance of 1.2 miles from FH ATC. Secaucus is one of the places for outlet shopping area, which is in 0.7 miles from the facility location. There are superstores such as Wal-Mart, Sam's Club, Marshalls, Pet smart, Best Buys, Kohls, Linens 'n Things, and Home Depot. Local merchants in the Town's Central Business District offer basic services that everyone looks for, as well. The nearest pharmacy is CVS, located in 1.3 miles from the facility. FH ATC would receive the general public input when we will have the opportunity to schedule Secaucus Zoning Board hearing.
Page 46 of 85
Appendix D: Google maps regarding the distance from schools and child-oriented locations, commercial shopping district and pharmacy.
Criterion 4: Dispensary specific considerations (TOTAL WEIGHTED REQUIREMENT up to 90 points] Measure 1: The applicant shall provide a plan for inventory, record keeping and security which shows an understanding of the types of records that shall be considered confidential health care information under New Jersey law and are intended to be deemed protected health care information for purposes of the Federal Health Insurance Portability and Accountability Act of 1996, as amended [HIPAA]. [WEIGHTED REQUIREMENT up to 10 Points] Response:
FH ATC is dedicated to protect the confidential medical information of its patients. It should be made clear to all employee of FH ATC on their first day of employment and reiterated repeatedly thereafter that they have a responsibility in maintaining confidentiality and privacy of operations simultaneously with confidentiality and privacy of clients, and each employee is accountable for his/her actions or inactions. Each employee has to sign a Letter of Confidentiality and training received prior to starting working in the ATC. All FH ATC staff will:
Comply with the defined responsibilities and practices in the FH ATC Operation Manual section. Adhere to all applicable New Jersey State laws and regulations. Protect the registered qualifying patient's right to confidentiality with regard to patient’s records and health conditions, including all FH ATC policies and procedures for HIPAA compliance. Ensure the legitimacy of all orders and the accuracy of dispensing records and labeling of the order dispensed to registered qualifying patients and registered caregivers. Serve and satisfy registered qualifying patients’ and registered caregivers’ health needs pursuant to New Jersey State Health Department MMP. Communicate with registered qualifying patients while protecting their protected health information (PHI) in accordance with HIPAA guidelines and FH ATC Privacy Policies. Minimum Necessary Use and Disclosure of, and Requests for, Protected Health Information Receive all necessary training regarding confidentiality and privacy of operations and registered patients of FH ATC. Immediately notify one of the principal officers of FH ATC about unauthorized release of confidential patient’s information noticed by the employee.
Page 47 of 85
In the case of employee violation of patient’s confidentiality and privacy of FH ATC, there will be termination of employment and submission of a report to New Jersey Health Department.
a) Recordkeeping FH ATC will have the engagement letter from the best known software providers of business record keeping and tracking system for medical marijuana dispensaries and growing facilities. It is Proteus420, which is providing necessary onsite assistance and educational materials about the program. There is a monthly charge for using this software. Employee access to confidential patient's information will be restricted. Our comprehensive computerized record keeping system will be in HIPAA compliance. This software has several pages: 1. The Patient's Page - shows detailed patient information, electronic medical documents, warnings about expiring cards, keeps notes about the patient, enables printing of custom patient bar codes; 2. The Patient Queue - enables checking in patients as they arrive, gives warnings about expired cards, alerts about upcoming birthdates, organizes the patient's waiting list; 3. Patient Visits - shows previous purchases by the patient, enables customization of every item on the menu, gives discounts to the patients, enables printing and scanning of bar codes, tracks cash, checks and credit cards. 4. Inventory's Page - lists everything in the inventory, enables searching and filtering of inventory items, create bar codes, calculate totals with taxes, alert about low inventory and see amount remaining in the inventory, keeps track of medical marijuana identified for disposal. The New Patient Intake procedure requires that patients/caregivers present their registration cards. FH will also issue its own photo identification card for its registered qualifying patients, necessary not only for security, but also for Point of Sales control (POS). This card will link patient's information (name, address, ID number, amount of medicine distributed, and monthly medicine's limit) to computerized POS. This measure would prevent any distribution of medical marijuana in excess of legal limits (2 oz. per month). At the end of the day this system shows the number of patients that came during the day (week, month), the total sales during the day (week, month) records. Sensitive Patient Information (SPD) system will be segregated from POS. Hardcopies of all transactions, SPD, sales receipts with patient's signatures, invoices, agreements with vendors of paraphernalia, vendors of the software and all receipts from construction and security companies will be kept in the secured filing cabinets in the main manager's office. The hardcopies can include, at minimum: Page 48 of 85
A. Business records, including sales records, indicating the name of the qualifying patient or primary caregiver to whom medical marijuana was distributed, the quantity and form, the price of the product and carbon copies of the signed receipts. B. The by-laws of the ATC and sub-contractor, if any, shall contain provisions relative to the disposition of revenues and receipts as it is necessary and appropriate to maintain and establish ATC non-profit status. b) Inventory FH ATC Dispensary will conduct an inventory audit every month to ensure absolute accuracy and accountability. It will start its operation with no medical marijuana on hand , which will be shown in the initial inventory. Inventory audits will review: 1. Daily Sales Reports; 2. Credit card receipts; 3. Daily closing checklists; 4. Amount of medicine in the vault; 5. Alert about low inventory; 6. Calculate total. Inventory control helps to implement FH ATC's primary mission - to provide a steady supply of high quality medical marijuana to registered qualifying patients, and also provide full transparency for the inspection audits. Tracking the inventory will help ATC to know what strains are moving and needed more. It will also show, if profit is made or not. It will also help to manage any discrepancies done by employees on any given day. The inventory shall include damaged, defective, or adulterated marijuana awaiting disposal, including the name, quantity, and the reasons for which the ATC is maintaining the marijuana for disposal. The record will also show the manner of the disposal and persons present during the disposal with their signatures. This record should be kept for at least 2 years. To ensure inventory control measures, a barcode system with Radio Frequency Identification Tags (RFID) will be implemented for security and safety. This automated process will provide instant access of any product that has left the facility. The barcode system will be used for small items that have been packaged and are placed in a warehouse inventory management system. The record of any inventory will include: the date of inventory, a summary of inventory findings, the name, signature and title of the individuals who conducted the inventory. FH ATC will transcribe inventories taken by the use of oral recording device. c) Security The FH ATC Dispensary has adopted a policy that protects the privacy and confidentiality of protected health information (PHI) whenever it is used by FH ATC Dispensary representatives. The private and confidential use of such information will be the responsibility of all individuals with job duties requiring access to PHI in the course of their jobs. PHI refers to individually identifiable health information received by the FH ATC Dispensary. PHI information includes medical conditions, health status, physician recommendation, and self-assessed records. Page 49 of 85
Personnel record and disclosures of PHI will be maintained for a period of six years as required by federal law, unless a state law requires a longer retention period. Records that have been maintained for the maximum interval will be destroyed in a manner to ensure that such data is not compromised in the future in accordance with the FH ATC Dispensary’s record destru ction policy. Patients' confidential information is stored in the network system and on hardcopies. a) The hardcopies of patients' records will be stored in the locked filing cabinets. b) Any unauthorized attempt to access to patients' information results in the automatic generation of failure, which is logged in the security logs for each server. Security logs are reviewed by the Network Administrator on a daily basis. The software will be checked for anti-virus protection and other critical data protection on a daily basis. FH will also use a hardware system and an online back-up system to protect patients' information. All security threats and breaches will be reported in the Critical Incidence Report. Security awareness training regarding patients' information confidentiality is mandatory and is provided for all employees on an ongoing basis. Appendix M: Letter from software provider Proteus 420, Inc Appendix G: Operation Manual: Sample of Employee Confidentiality Agreement on p. 36 and Critical Incidence Report on p. 51.
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA). Measure 2: The applicant shall submit a description of its proposed program for providing counseling and educational materials regarding methods of administration and research studies on health effects of medicinal marijuana to registered qualifying patients and their registered primary caregivers. The applicant shall submit a description of its historical relationship with clinical or research activities, if present. [WEIGHTED REQUIREMENT up to 20 Points] Response:
(a) FH ATC—dispensary will maintain, and make available for distribution to registered qualifying patients and their primary caregivers, an adequate supply of up-to-date informational materials addressing the matters identified in the policies developed pursuant to N.J.A.C. 8:6411.1. Informational materials will be developed by FH ATC together with Medical Advisory Board and additional materials, obtained from Americans for Safe Access organization. (b) Informational materials will be available for inspection by the Department upon request. Page 50 of 85
(c) FH ATC—dispensary will provide registered qualifying patients and their primary caregivers with a notice requesting approval for the FH ATC —dispensary to contact registered qualifying patients and their primary caregivers with information concerning on-going peer reviewed clinical studies related to the use of marijuana. Besides brochures, in adequate supply in the waiting room of the dispensary, FH will also have there a wall monitor, showing educational information. The brochures can be taken by registered patients for their everyday usage at home. This information will be available for the patients when he/she is checking in as a new registered patient of FH ATC. FH ATC will have specially trained employee (Social Worker) who can explain all necessary information to the registered patients too. The educational materials will contain: 1. 2. 3. 4. 5. 6. 7.
Legal information; Rules and prohibitions in ATC; Potential side-effects of medical marijuana; Alternative methods of consumption of medical marijuana; Safe techniques for using medical marijuana paraphernalia; Signs and symptoms of substance abuse; Information on tolerance, dependence and withdrawal.
Marina and visiting Ida Umanskaya, officers of FH, started research in medical medical marijuana field in Karavas 2008, later Colorado, California and Israeltheir to understand marijuana program. Today it is a very new developing field with a lot of restrictions. At the present time, FH ATC Officer Ida Umanskaya is working with Beilis Development Laboratory on formulating and producing the safest and most beneficial transdermal topical formulation for the fastest cannabinoid delivery. The clinical testing and research is holding in California, where it is legally done in medical offices. FH ATC future consultant Steven B. Castellano has the experience and ability to participate in any clinical research pertaining medical marijuana industry. He was performing microbiological analytical research and was a Lead chemist in Umpqua research Company and in Pyxis Laboratories, LLC. Appendix I: Patent, DVD explaining future formulation and letter from Beilis Development
laboratory. Appendix G: Operation Manual, Educational information of FH ATC, pp. 55-82
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA). Measure 3: The applicant shall provide an acceptable safety and security plan, including staffing and site, and a detailed description of proposed security and safety measures which demonstrate compliance with the Rules Related to the Medicinal Marijuana Program. [WEIGHTED REQUIREMENT up to 25 Points] Response: Page 51 of 85
Safety and Security plan for FH ATC includes: I. Constructing of a secured and safe facility site, implementation of Security Alarm System;
Page 52 of 85
Page 53 of 85
Page 54 of 85
Appendix N: Facility Floor Plan and Description. Appendix G: Operation Manual, Protocol for Testing and Maintenance of the Security Alarm System; Root cause analyses of breach of security, pp. 42-46
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA).
Page 55 of 85
II. Employee security; III. Patient security; IV. Security measures from theft and diversion; Appendix G: Operation Manual: Opening and Closing procedures p. 22, Personal Safety and
Crime Preventing Techniques, Reportable Event Reports, Employee Security, pp. 48-52 NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA). Board of Directors of future FH ATC decides to preferably accept payment for medicine by money orders or credit cards. FH ATC employee will encourage our future registered patients to make payments in these forms for better security and transparency for audits and inspections. FH ATC can use the Transaction Group as the Medical Marijuana Merchant Accounts providing Medical Marijuana Dispensaries with reliable credit card processing. Cash transfer to the bank would be done daily at different not scheduled times for security reasons. Appendix G: Operation Manual: Root Cause Analysis on p. 42, Reportable Event Reports on p. 49.
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA). V. Emergency and Disaster plan.
The purpose of the Workplace Emergency and Disaster Plan is to prepare FH ATC employees how to react in the unlikely event of a workplace emergency or disaster. Our goal is to protect lives and property in the event of an emergency. These are some examples of situations that could affect business operations and would be considered workplace emergencies: Floods, Hurricanes, Tornadoes, Fires, Explosions, Civil Disturbances, Bomb Threat, Power Failure, and Workplace violence resulting in bodily harm and trauma. IN THE EVENT OF AN EMERGENCY THAT POSES IMMEDIATE RISK TO PERSONAL HEALTH AND SAFETY, EVACUATE IMMEDIATELY AND PULL THE NEAREST FIRE ALARM PULL STATION OR CALL 911 AS SOON AS POSSIBLE FROM A SAFE LOCATION, ALERT HOSPITAL AND PARAMEDICS POLICE OR 911 BOMB SQUAD. Appendix G: Operation Manual: Full description of Emergency and Disaster plan on pp 50-52.
Page 56 of 85
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA). Every employee will receive a copy Employee Handbook during their orientation training, which includes procedures for robbery, natural disasters, evacuation plan and safety and security techniques, to ensure the safest well-being of all FH ATC staff and registered patients. They have to sign Employee Training Letters. Appendix G: Operation Manual: Employee Training Letter on p. 107. Measure 4: If the applicant proposes to cultivate and dispense at two separate physical locations, the applicant shall provide an acceptable delivery receipt plan, including measures to ensure sanitary medicinal standards, security and inventory control, for the receipt of medicinal marijuana from the cultivation site by ATC staff at the dispensing site. The delivery receipt plan shall demonstrate compliance with the Rules Related to the Medicinal Marijuana Program. [WEIGHTED REQUIREMENT up to 5 Points] Response:
Dispensary and Plant Cultivation of FH ATC will be built at the same physical location, which ensures the better security for FH ATC operations. Measure 5: The applicant shall submit a description of its Medical Advisory Board including expertise of members and describe the plan to address community issues, including but not limited to, labeling issues and an overall review of community relations. [WEIGHTED REQUIREMENT up to 10 points] Response: FH ATC doesn't have a Medical Director on its premises, due to considerations written below:
1. Code of Medical Ethics says that Physicians may not accept any kind of payment or compensation from a drug company or device manufacturer for prescribing its products. Furthermore, physicians should not be influenced in the prescribing of drugs, devices, or appliances by a direct or indirect financial interest in a firm or other. 2. NJ Board for Professional Medical Conduct prohibits Physicians to distribute controlled substances and receive proceeds of drug transaction. 3. The permission to have Medical Director (Physician) on the payroll of Medical Marijuana ATC contradicts NJ Compassionate Act, AMA Professional Conduct and could have enormous negative impact on the pa tient’s health and can cause the increase of fraudulent Medical Marijuana prescription. 4. American Doctors are accepting Federal funded Medicare Insurance, at the same time medical marijuana is prohibited by Federal Law. FH ATC will have a voluntarily working Medical Advisory Board, whose members are affiliated with NJ Hospitals, and this panel is appointed by FH ATC. Page 57 of 85
Purpose
The purpose of FH ATC Medial Advisory Board is to provide FH ATC with up to date, scientifically accurate information about medical marijuana. Medical advisory board will also review the results of registered patient's satisfaction surveys and their self assessment records to provide its experience and input on the evolution of the work of FH ATC, thus helping to improve the quality of life of registered qualifying members and in future cannabis clinical research.
Role
FH Medical Advisory Board serves as a representative link between FH ATC and medical community. Its role is primary advisory, however, they may, on behalf of FH, actively engage in other activities that promote education, awareness, and other activities that benefit the community of registered qualified patients and their primary caregivers in Medical Marijuana Program (MMP). Medical Advisory Board will observe the effects of medical marijuana use on FH ATC's registered patients through the special self-assessment records, described in 8:64-11.4. In summary, the registered patients, the community and the physicians would benefit through FH ATC Medical Advisory Board observations. The chairman of the Medical Advisory Board shall be responsible for the provisions herein. The governing body of the Medical Advisory board is the Board members themselves, and it is their decisions that are implemented for the Medical Advisory Board. Medical Advisory Board does not make decisions for FH ATC; however their input is highly valued in medical topics. Medical Advisory Board will meet at least two times a year. The duties of the FH ATC Medical board are as follows, but in no way limited by this list:
Support FH ATC to develop a Medical Model of ATC, to provide registered qualifying patients, their caregivers and healthcare providers with current, scientifically accurate information on medical marijuana; Participate in development of special Self-Assessment Records for FH ATC; Review Self-Assessment Records, analyze them and share with the medical community and NJHSS; Review FH ATC website and other communications for medical accuracy; Promote communication among the medical community in regards of MMP; Participate in appropriate activities that enhance the FH ATC and medical community to improve the quality of life of qualified registered patients in MMP and to support their primary caregivers and families; Research new developments in the field of medical marijuana; Page 58 of 85
Provide FH ATC with newest legal information in the field of medical marijuana industry.
Medical Advisory Board of future FH ATC:
1) Dr. Aleksandr Martirosov, D.O. License number: Dr. Martirosov is the head of Tri State Health and Wellness Medical Center, located at 31-00 Broadway, Fair Lawn, NJ 07410. He is a member of American College of Acupational and Environmental Medicine, American Society of Addiction Medicine, American Pain Society and the National Guild of Hypnotists. He has the license in Controlled Dangerous Substances, license number D07562200. He is designated as Certified Medical Review Officer, and he is an active member of A4M, a Society of Physicians and Scientists Dedicated to Enhancing the Quality and Extending the Length of Human Lifespan. Dr. Martirosov is very knowledgeable in alternative medicine and medical marijuana field. He already applied to be registered in MMP in NJHSS. Dr. Martirosov has privileges in the Meadowlands Hospital. Dr. Martirosov is the owner of Tri State Health and Wellness Medical Center.
2) Dr. Dmitry Shtillman, D.D.S. License number: Dr. Shtillman is the head of CavityFree dental care clinics located at 45 Route 46 East, Ridgefield Park, NJ 07660. Dr. Shtillman is a pediatric dentist, and an expert in a "special need" patien'ts dental care. He is the attending dentist at Hackensack University Medical Center, and is the member of Credential Committee of United Health Care Dental. Dr. Shtillman is the owner of CavityFree dental clinics.
3) Yuri Surin, Registered Nurse License Works as
a
Registered
Nurse
number: in Presbyterian
Hospital,
New
York,
NY.
Has a certificate of credit for participation in the Fifth national Clinical Conference on Cannabis Therapeutics in May 2009 (Certificate is submitted) from University of California, San Francisco. 4) Peter P. Wimmer, Massage Therapist License number: Works as a massage therapist in Tri State Health and Wellness Medical Center, located at 31-00 Broadway, Fair Lawn, NJ 07410. 5) Freya Sat, President of Self-Awareness and Transformation Center, located at 126 Park Avenue, East Rutherford, NJ 07073. Freya Sat is the owner of Self-Awareness and Transformation center. Page 59 of 85
6) Sonya Bromberg, Esq. Sonya Bromberg works as an Attorney at Law. She is admitted to practice law in New Jersey, New York and Utah and in Federal Court thereof. Sonya is very knowledgeable in legal aspects of Medical Marijuana Program in New Jersey and other states. Current concentration: Corporate consulting and Human Rights litigation. 7) Elena Nikitina, Registered Nurse License number: Works as a registered Nurse in Good Samaritan Hospital, 255 Lafayette ave, Suffern, NY, 10901 8)
9) a patient, who has a lot of debilitating medical conditions (We cannot provide them here for confidentiality reasons). She resides , is also supporting our location choice in the city of Secaucus, which has one of the best transportation accesses in Northern Region. Her letter of support is in Appendix J. Our Medical Advisory Board can help FH ATC with labeling issues, according to FDA guidelines, if they arise. Dr. Martirosov explained FH, that it is FDA Policy that people have the right to know everything about the product they are buying: ingredients, how it was processed, and etc. The patients are choosing to buy this medicine, so they must have the whole information about the medicine and its side effects. Dr. Martirosov consulted Ida Umanskaya regarding the project of transcutaneous formulation for Topical Lotion. FH ATC has a future Medical Advisory Board, comprising of 9 members, five of whom are health care professionals: one physician, one dentist; three business owners in the Northern Region and a future patient, qualified for MMP in NJ. Appendix H: Copies of Certificates and Licenses of Medical Advisory Board members and Bylaws of Medical Advisory Board.
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA). Measure 6: The applicant shall submit a plan to track and analyze data including but not limited to patient outcome, utilization and trends. [WEIGHTED REQUIREMENT up to 20 points] Response:
Page 60 of 85
a) FH ATC will formulate a system for documenting a patient’s self -assessment of pain and/or primary qualifying symptom using a pain rating scale. FH ATC serving different patient populations will make more than one pain scale available for patient use, as appropriate. b) FH ATC will document a patient's self-assessment of pain or primary qualifying symptom upon commencement of the dispensing of medical marijuana to the patient and thereafter at three-month intervals. The ATC will maintain the record for the patient’s use and information in consulting with his or her physician as to the use of medical marijuana to address the patient’s qualifying debilitating condition. c) ATCs will provide ―log books‖ to registered qualifying patients and registered primary caregivers who request them to keep track of the strains used and their effects.
The collection of these data is needed: 1) For FH ATC to know what kind of strains are more beneficial for its registered patients and needed to be grown; provide information to participating physicians and NJHSS. 2) For NJHSS for statistical and clinical data. 3) For registered patients and their caregivers for sharing with their prescribing physicians. 4) For the medical community, serving as a clinical research data. To be consistent with Medical Model of ATC, FH ATC developed several Self-Assessment Records: 1) Patient’s record of strain used; 2) Self-Assessment Record with UKU Side Effect Rating Scale - Effects of cannabis administration may be assessed by this standardized inventory scale, showing physical and psychological symptoms and also side-effects. This test will show the physician if he/she has to reduce the dose to the patient, discontinue administration of medical marijuana or take no action. 3) Self-Reported Pain Magnitude Test - This test is based on verbal reports of pain intensity and pain relief after administering medical marijuana. This scale starts at 0 - no pain; slight; mild; moderate; lots; complete; severe; worst; and continues to 10 - worst pain imaginable. 4) Sickness Impact Profile (SIP) - It is a behaviorally based measure of sickness related dysfunction. It is done in an effort to provide appropriate, valid and scientific measures of thatStates will aid in assessing thethe outcome of administering medical marijuana. 5) health Profilestatus of Mood (POMS) - shows psychological and energetic effect of medical marijuana administration. 6) Highness/Sedation Scale - The development of tolerance is an important factor that may influence psycho-physiological effects of medical marijuana. Initial tolerance is an expression of dose of medical marijuana, which a patient must receive at a first exposure to it to produce a designated degree of effect. "Acquired change in tolerance" is the result of repeated drug exposure. FH will develop a psychological tolerance test showing: highness, somatic, awareness, a feeling of control, friendliness, ambivalence and altered thinking. 7) Visual Analog Scale test- after using cannabis.
Page 61 of 85
FH hopes that the results of these tests will help NJHSS, physicians and future patients in scientific and clinical research of medical marijuana, and will be a reference to prescribing physicians. The results of these tests would lead our trained staff of professionals to direct a patient towards the right products for his/her needs, and to the right source of information. FH will work collaboratively with registered qualifying patients, their physicians, and our Medical Advisory Board in maximizing positive therapeutic outcomes through the usage of medical marijuana. FH have about begun possible a conversation with Concentra Urgent Care,was located Seaview Health drive, Secaucus future affiliation. Our representative talkingonto30 Concentra Service manager William Miller, who is consulting the National authorities. Appendix G: Operation Manual: Samples of Self-Assessment Records on p. 83-90.
NOTE: FOR OFFICIAL USE ONLY, LIMITED FOR PUBLIC REVIEW, CONTAINING CONFIDENTIALITY AND PROPRIETARY INTELLECTUAL PROPERTY. Criterion 5 Cultivation specific considerations [TOTAL WEIGHTED REQUIREMENT up to 100 Points] FH would grow organic marijuana and Board of Directors would oversight that plant cultivation is in compliance with a certification of the United States Department of Agriculture requirements applying to organic products. Appendix G: Operation Manual: Basic Requirements for Organic Certification on p. 110.
FH would use growing consultants from California and Nevada for harvesting during the first year as well as to train our own NJ residents- growers, who could work independently in the future. It would help FH to lower our expenses, thus, lowering the future price of medicine for our registered patients. FH ATC will grow organic marijuana as environmentally friendly, more resistant to disease and most healthy medicine for patients with debilitating conditions. Measure 1: The applicant shall provide an acceptable safety and security plan, including staffing and a detailed description of proposed security and safety measures which demonstrate compliance with Rules Related to the Medicinal Marijuana Program. Supporting documents should be included as Appendix N. [WEIGHTED REQUIREMENT up to 20 Points] I. The description shall include a detailed floor plan for the ATC cultivation site, which indicates location and design standards and performance specifications of security devices to be utilized.
Page 62 of 85
Response: STAFFING FOR GROWING
FH ATC will employ a team of experienced growing consultants who have the best expertise in a large scale organic growing. They have extensive experience in horticulture, organic growing, and NJHSS regulations about THC potency limit. They have connections in all states with MMP and can provide witheager best to techniques, equipment andwho the can latestwork information in cannabis growing. They areusalso train FH own growers, independently in the future. The team is comprised of GrowSet Up team and Nick Tarantino. FH ATC consultant, Steven D. Castellano will be the head of our control/quality program. FH ATC future grower Maya Gogua has BS in Agronomy and Horticulture and 10 years of indoor mass growing experience. FH hopes it would not take a long time for her to become a cannabis grower. Georgiy Akopov is FH ATC future assistant grower. He is studying medical science in Bergen College and is eager to be trained as a grower. Appendix O: FH ATC Growing Staff information and reference letters. Facility floor plan
A detailed floorisplan with location and design standards and performance specifications of security devices in Appendix N. Complete security measures are described in Criterion 4, because FH ATC Dispensary and Plant Cultivation operations are held in one facility. Appendix N: Facility Floor Plan including all security measures from ADT and Tour-Positive system from U. S. Security Associates Inc.
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA) II. The applicant shall provide a plan to involve and coordinate with local law enforcement authorities on security and safety issues, and identify the law enforcement officials contacted during the development of this plan. Response
Local law enforcement agencies would play an important role in securing ATC operations, preventing the theft and diversion and providing security around the facility. FH developed a plan of coordination with local police authorities: 1. FH ATC officers will report to local police concerning possession, distribution or transfer of illegal drug or other unauthorized controlled substance, and will turn over to the custody of law enforcement officials any such substances found during a search of an individual or property. FH ATC will cooperate fully in the prosecution and/ or conviction of any violation of the law.
Page 63 of 85
2. FH ATC will announce to the registered patients and/or their primary caregivers that, if they are in possession of unused, unadulterated medical marijuana, that is no longer needed for their use, to dispose it by: - Returning to FH ATC - Transporting it or arrange for pick up by state or local police 3. FH ATC will have the agreement with local police about pick up of disposable marijuana from our premises. A special Disposable report has to be signed by the Executive Director and Police Officer, responsible for ATC pick up. of this substances report has to be given such Police Officer. who Policeis will assure FH thatAallcopy controlled coming intotopossession of Police department are properly recording, securing and transporting to the Crime Lab. 4. A security system, provided by ADT will be utilized with a communication configuration, notifying law enforcement officials if a break-in or a robbery occurs. 5. Burglar alarm (Hold Up) will silently notify local law enforcement officials about any breach of security. 6. FH ATC will provide law enforcement authorities with names and phone numbers of the Board of Director's officers and FH General Manager to notify during and after operating hours, to report problems with the establishment, or noticing any smell, noise, loitering or any other potential concerns. 7. Upon becoming aware of reportable loss, discrepancies identified during inventory, diversion or theft, whether or not the medical marijuana funds or other lost or stolen property is subsequently and/ or notify to responsible parties are identified and action taken against them, FH ATCrecovered will immediately law enforcement authorities. 8. If a robbery occurs, the police will be notified immediately. Employees must not touch anything in the facility. FH ATC staff will cooperate with Police and issue a Complete Incident Report. 9. Receiving the alarm signal, police authorities would enter the ATC together with FH ATC officers and /or general manager. 10. Local police authorities will be in contact with ADT Security Company monitoring and with U.S. Security Associates, Inc FH Directors Marina Karavas and Ida Umanskaya had a meeting in Secaucus Police Department with Chief of Patrol Captain Joseph P. Kickey, Detecive Sergent Carlos Goyenechea and Detective Michael Torres together with U. S. Security Associates Inc, District Manager Northern NJ Mr. Joseph Marini on 02.08.2011. Police officers were informed about our application filing process to get the license for future ATC and the full description of our possible projected work together. The Police officers are going to consult the District Attorney about this new project in MMP and work with us accordingly, if we are awarded with the license. Our future ATC site will be secured by professionals from U.S. Security Associates Inc. with deep tiers to local enforcement. NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA) Measure 2: The applicant shall provide a description of the enclosed, locked facility that would be used in the cultivation of medicinal marijuana, including steps to ensure that the medicinal marijuana production shall not be visible from the street or other public areas. Page 64 of 85
[WEIGHTED REQUIREMENT up to 30 Points] Response:
Cannabis will be grown in "a closed" system with strict environmental control (encapsulated system).It is like the enclosed box built inside the growing area. There will be a metal cage around box as security measure. The growing the state monitored of art climate control. this Ambient aira temperature and relative humidity spaces (RH %)will willhave be remotely and regulated each time of monitoring through the computerized environmental control system. Carbon dioxide (CO2) enrichment will be employed to aid in photosynthesis to maximize plant yield and efficiency. Indoor air quality and HEPA filtration will be employed throughout the structure to maintain mold-free environment for the safety of staff and health of the plants. FH Growing facility will use negative air pressurization to eliminate air exchange from Plant Cultivation area to the Dispensary. All exhausted air will be emitted from the building through charcoal filtration and ozone treatment for the neutralization of odor (volatile organic compounds). This level of environmental biological control will ensure that cannabis will be of the highest level quality and purity. The plant cultivation facility will be light tight, with no visibility from outside of the building. Exhausted air will be treated by carbon scrubbing and ozone generation to ensure that no "telltale" odors arevisible emitted to thethe outside. There will be no windows so the activities inside the facility are not outside building. FH ATC building is going to be modified with excellent security system, robbery prevention setups a good man-trap with a buzzer door and at least two security guards with metal detectors.
The outside perimeters of FH ATC will be well lighted to deter nuisance and criminal activity and facilitate surveillance, but will not disturb surrounding businesses and any neighbors The outside perimeters of FH ATC will have limited to a minimum access to ensure that access is well controlled FH ATC will be protected against theft and diversion 24 hours a day and seven days a week by a security alarm system, provided by ADT Business Security Company Outdoor and indoor monitoring cameras in all rooms of the facility working 24/7 and connected through the computer to the ADT and law enforcement agencies.
For the reasons of security and according to NJ Health Department rules and regulations:
FH ATC will have an exterior signage as a black text on white background
This signage will not be illuminated at any time
FH ATC will not display on the exterior of the facility advertisements for medical marijuana or brand name, except for purpose of identifying the building by the permitted name. Page 65 of 85
Medical marijuana and paraphernalia will not be displayed or clearly visible to a person from the exterior of FH ATC. Small windows and roof hatches shall be secured with bars on the small windows so as to prevent unauthorized entry. Big windows on the side walls will be removed and a blind brick wall will be built.
NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA) Measure 3: The applicant shall demonstrate an ability to provide a steady supply of medicinal marijuana to registered qualifying patients. [WEIGHTED REQUIREMENT up to 50 Points] Response:
Using the weekly periodical reviews and information from NJHSS about registered patients in Northern Jersey, FH ATC would adjust its growing, dispensing capabilities and the quality of medicine. We would use Sea of Green (SOG) technology, increasing weekly growing and growing steadily to provide steady adequate supply of medical marijuana to our future registered patients. SOG is a perpetual harvest method, providing small harvests on a weekly basis. Each week, the ATC decides to cultivate a new batch of medical marijuana. This will provide the patients with constant and steady supply of medicine. At the same time we can decrease our inventory in 10 business days if we experience a temporary decrease in the number of patients. Our future product will meet the standards of modern medicine: quality, safety and efficacy. If in the future we would ever need to increase square footage area for the growing, our growers would use the method of growing in tiers or shelf gardening. 3,000 lumens per sf. would be an optimal for our indoor growing. FH ATC will use organic methods of growing with no chemical pesticides or fertilizers. The actual number of plants in ATC will be consistent with New Jersey Rules and Regulations stated number of strains permitted and number of qualifying registered patients. FH will also have a staffing plan that is commensurate with the rate of enrollment by qualifying patients FH will make its growing calculations based on a yield per plant, how many plants are grown under each lamp and the projected number of patients with 2 oz limit of medical marijuana allowed by NJ Act. Due to a definition of 60-Day Supply made by WAC 246-75-010, 35 oz. per sf. of canopy is a reliable prediction of plant yield. If one of the areas of Plant Cultivation facility is compromised due to unforeseen issues (pest, disease, grower error), FH Master Grower has to extra grow to compensate for delays and setbacks. The Executive Director and Plant Cultivation Manager will conduct a harvest projection at least once per week. FH ATC computerized system will estimate the projected dry yield for the next 12 weeks. In the event there is a surplus of inventory according to actual patients' number, the Executive Director adjusts the production schedule and the surplus of dry inventory has to be destroyed according to Rules and Regulations and FH ATC Disposal Policy. Page 66 of 85
Regardless of our projections made in the Business Plan, we would always correspond our harvesting to the actual number of patients registered in FH ATC. We are confident that our yield and production cycle knowledge , together with the knowledge of the exact numbers of registered patients and more than enough square footage of the Plant Cultivation facility will be the keys to adequately and steadily supply patients from Northern NJ region in accordance with patients' demand. The plant cultivation area and growing process are easily expandable to meet the increased demands of Northern region, strictly adhering to the FH registered patient's database. I. The applicant shall provide a start-up timetable which provides an estimated time from issuance of an authorization for operation to limited operations to full operation, as well as the basis for these estimates.
Page 67 of 85
Appendix G: Operation Manual: Coconut Coir on pp. 118-119. At the same time there will be a construction process of Plant Cultivation Facility on a large scale, which is supposed to take 2, 5 months and then a process of testing this facility for at least one week.
.
Page 68 of 85
- Projected number of registered patients at the beginning of MMP ( FH hopes to get numbers of registered patients for Northern NJ region from NJHSS, if it will be awarded with license to operate ATC) TIMEFRAME Date 3/21/2011
3/21/2011
4/5/2011
4/5/2011 4/15/2011
4/15/2011 4/15/2011
4/25/2011 4/28/2010 6/15/2011 6/05/2011 6/22/2011 6/29/2011 6/30/2011
Event Approval of Application Lease Begins
Basis Tentative date listed by NJHSS Building is vacant; landlord contacted; obtained lease proposal Begin employee hiring process for FH already has consultants and future Cultivation Operations and Security assistant growers Guards from U.S. Security Associates Inc Begin construction/renovation of the Construction contractors have been facility contacted after getting building department permits. And are available Begin Security systems installation Agreement with ADT Security Company, security contractor/consultant Construction of a small Plant Projection by contractors, Grow SetUp Inc cultivation facility completed; Vegetative Room and Flowering Room equipment installed; testing completed Security installation complete to start Projection by ADT Security Company, pant cultivation operations security contractor/consultant Begin vegetative growth of first batch Facility construction complete and security from seedling in a small cultivation installed room Begin employee hiring process for FH already has personnel ready to work in Dispensary operations and training the dispensary Begin flowering of first batch Experience with MMJ cultivation
First batch harvested Second vegetative cycle started First Batch dried and tested for purity First batch cured, First batch packaged and labeled and is ready for sale. Stored and vented for 1 day. 7/01/2011 ATC is at full operation
Experience Experience with with MMJ MMJ cultivation cultivation Projection by contractors, GrowSetUp Inc Experience with MMJ cultivation Experience with MMJ cultivation
Product is ready for distribution; Perpetual harvest technique will provide patients with a steady supply from this date on, subsequent harvest will occur on a weekly basis from this point forward Page 69 of 85
II. The applicant shall describe its knowledge of (and experience with) organic growing practices or agricultural growing practices to be used in their cultivation of medicinal marijuana.
Cannabis will be grown in "a closed" system with strict environmental control (encapsulated system). Ambient air temperature and relative humidity (RH %) will be monitored and regulated each time of monitoring through the computerized environmental control system. Carbon dioxide (CO2) enrichment will be employed aid in photosynthesis to maximize yield and efficiency. Indoor air quality and HEPAtofiltration will be employed throughoutplant the structure to maintain mold-free environment for the safety of staff and health of the plants. FH Growing facility will use negative air pressurization to eliminate air exchange from Plant Cultivation area to the Dispensary. All exhausted air will be emitted from the building through charcoal filtration and ozone treatment for the neutralization of odor (volatile organic compounds). This level of environmental biological control will ensure that cannabis will be of the highest level quality and purity. The water for cultivation will be purified via reverse osmosis system. Only organic fertilization will be used. The plant cultivation facility will be sanitized by preferably organic cleaning agents. Materials used for the harvest and storage of dried marijuana plants will be consistent with those used in pharmaceutical industry. Nick our futureBlu) General Growingknowledgeable Consultant andinGrowSetUp Inc. ( Egor Koltsov, DavidTarantino, Koltsov, Alexander are extremely organic growing. Steven D. Castellano, having a great experience in cannabis growing and testing and MS in soil science and project management will consult us and our consultants at any time we will need his services. Appendix M: Reference letters from growing consultants.
Operation manual contains all basic requirements for organic certification by USDA, which has to be implemented in FH ATC growing facility. USDA doesn't give any certification for organic medical marijuana, due to Federal laws, but FH plant cultivation will follow necessary best practices and USDA guidelines for organic growing. Organic cannabis is environmentally friendly. Organic method is a technique of using no pesticides and chemical fertilizers. It has to be entirely organic operation. Growing medium is usually a combination of natural organic material and numerous composts. FH would use Coconut coir for organic growing, no pesticides, organic fertilization and reverse osmosis for water. Organic fertilizers are less concentrated than chemical mixes, and the nutrients are released more slowly. Here is a short list of common organic fertilizers: Alfalfa Pellets, Corn Gluten, Compost Bird guano, Cow manure, Horse manure, Soybean meal, Worm castings, Kelp, Insect manure, Fish emulsion, Cottonseed meal, Bone meal, Blood meal. A special attention has to be paid to Growing Medium acidity. Note: Blood Meal, Dried Blood, Guanos, Kelp Meal, Cotton Seed Meal, Peat Moss, Sulfur and fish meal are all acidic and can bring ph down ( PH has to be monitored while use).
Page 70 of 85
Note: Bone Meal, Rock Phosphate, Wood Ashes pretty much all ashes, Shellfish Compost and Crab Meal are all alkaline and can make ph go up ( PH has to be monitored while use). III. The applicant shall describe its quality control program and steps that will be taken to ensure the quality of the medicinal marijuana, including purity, potency and consistency of dose. Quality, purity, consistency of marijuana: The quality of any consumable plant is dependent
upon ability include: of the grower to provide an optimum growing environment. Thesethe elements • Moisture • Air flow • Nutrition • Temperature • Light When all elements are controlled to meet the specific plants needs, the highest quality will be achieved and the plants will have a lower stress level allowing them to resist diseases and pests. Such control can only be reached in Controlled Environmental Agricultural system (CEA), which GrowSetUp, Inc. is going to build for FH ATC. Controlled Environment Agriculture (CEA) and the environment in a Plant Cultivation room are tightly controlled for maximum efficiency. With this CEA grower can make ultra-premium medicine regardless ofand growing seasons, anywhere in the world, constantly monitoring thea humidity, temperature pH level. The future Plant Cultivation facility will be designed with patient in mind and built to medical laboratory standards, while maintaining our objective to be environmentally friendly and producing the best medical cannabis possible. The facility will have completely sterile walls and medically sealed floors, which mitigate any risk of mold or pest. Each sector of the facility will have an optimum temperature and environmental control necessary for maximum production of cannabis. To maximize the space, if needed, we will use several tiered vertical hydroponic design. Additional horticultural practices that will enhance the ability to achieve the quality goal include but are not limited to the following: •
Using quality seedlings for initial plantings
•
Cloning female plants to ensure consistent genetics
•
Growing female seedlings having disease resistance
•
Maintaining consistent growing conditions and practices to retain THC potency
•
Flushing plants prior to harvest to remove any residual build up of any fertilizer or
•
pesticide that were used during growing
•
Visual microscopic inspection leading up to harvest for resin crystals to determine optimum harvest time within the recommended day frame to achieve proper THC level
•
Careful harvest to prevent friction which can affect resin
Page 71 of 85
•
Proper moisture and temperature management in the drying process to allow slow even drying which encourages minimum THC decomposition, taste, and encourages sweet smooth taste. This slow process also allows enough time for pigments to degrade improving taste and aroma
•
Vacuum sealing for storage will preserve the aroma, taste and potency
•
Storing in darkness in a cool dry place, maintaining proper temps, and humidity will help
•
preserve the ultimate quality of medicine
•
pharmaceutical grade packaging and storage containers
•
cleaning with preferably organic certified sanitizers
2. For the first ramp year, FH ATC would use Cannabinoid Analysis Test Kits (CAT) which is sold by www.cannalyse.com, providing THC and CBD cannabinoid potency and consistency of dose. Medicine should have as consistent dosage as possible. Therapeutic efficacy can only be achieved with repeatability of desired effects. This is an especially important factor for efficacy of THC, which are biphasic in nature. Biphasic refers to a chemical having opposite effects on the body if administered in different doses. Cannabis Plant health, regarding macronutrients, presence of pests, traces of pesticides and presence of mold will be consistently monitored. When preparing Oral Lozenges, titration of a consistent dosage is very important too. For the safety and purity of Topical Lotion, FH Director Ida Umanskaya is working on a formulation process with Beilis Development Laboratory, which is described prior. On the second year of operations FH ATC intends to build its own laboratory fulfilling the most accurate clinical testing of cannabinoids' potency, consistency of dose, and possibility of medicine contamination. Our consultant Steven D. Castellano is capable to build such laboratory and work there on a constant basis as analytical chemist. His excellent education and experience in medical marijuana field makes him irreplaceable specialist, and FH Board of Directors is happy to have his assurance to work with us! FH has a Letter of Intent from SteepHill laboratory from California, which will work with us on developing FH ATC own laboratory and comprehensive analysis system for potency and quality control of medicine. Our overall plan is to address the consistency of dose issue by growing plant in a healthy environment using consistent methods which will help re-produce healthy genetic clones. By beginning with consistent genetics and managing ―Best‖ harvesting, drying, curing and storage practices we will be able to achieve consistent final quality, purity and doses in our products which will be monitored by regular testing and record keeping. Special protocols with testing reports will be available in FH dispensary room for every registered patient and primary caregiver, thus assuring them that FH ATC produces the highest quality medicine and FH takes all serious precautions to ensure that our registered patients are receiving purest and safest medical marijuana and other infused products with a consistency of dose.
Page 72 of 85
Our consultant Steven D. Castellano was working as a chief of the Quality Control Testing Laboratory, he is a very experienced chemist and microbiologist. FH ATC considers his future help as invaluable input to our future Quality Control Programm. Appendix G: Operation Manual: Cannabinoid Analysis Test description on p 117-118. Appendix I: Letter of Intent from SteepHill Laboratory. IV. The applicant shall describe: Methods to ensure, that seed production and/or hybridization are prevented during cultivation of medicinal marijuana;
FH will be working exclusively with feminized seedlings to minimize the chances of seed production during cultivation. Subsequently we will be surveying the plants during the first stages of flowering to ensure that all plants are female (usually a male starts to flower 2-3 weeks before female). Constant temperature and humidity control will be essential to prevent male plants from forming. If any pod or sacs are formed the plant will be cut down and destroyed. Only approved cultivation staff and security personnel will be allowed access to the cultivation area. Methods of testing for the presence of mold, bacteria or other contaminants and procedures for routine scouting of insect and plant disease conditions;
Our procedure for routine scouting of mold and bacteria will include the careful observation of the plants. Each plant will be assessed daily. The room will be kept at the best temperature and humidity levels will be maintained (CEA). We will use a digital magnascope to identify contaminants as the ideal tool. If a product is questionable for mold, insects or bacteria a small sample from each plant may be tested via a "Gram Stain" or mold toxin dye. For performing mold identification testing, there are special aflatoxins and fumonisin testing kits in different biotech companies selling on Internet. As a part of quality control, our system of recordkeeping will permit the identification for purposes of recall of any lot or batch of medicine when such is found to be unsafe to use from FH ATC registered patients. In the future FH ATC will build a professional testing lab, which will allow us to clinically and precisely perform cannabinoid and contamination analysis of all our medicine. Methods to control insect pests that do not include the application of pesticides during cultivation of medicinal marijuana, in accordance with the Rules Related to the Medicinal Marijuana Program;
CEA system helps to eliminate insect pests and mold during cultivation process. Coconut Coir Growing Medium practically eliminates mold development. Integrated Pest Management (IPM) is just the adding of a natural predator to our ecosystem, like ladybugs, mantis, nematodes, parasitic wasps, bacteria, or a bug-attacking fungus such as milky spore. In our effort to control insects we can utilize the most effective and aggressive species: Ambluseius Californicus - kills numerous species of thrips and as well as mites, they feed on hatching eggs and lerval stages of thrips.
Page 73 of 85
Amblyseius Cucumeris - kills numerous species of thrips and as well as mites, they feed on hatching eggs and larval stages of thrips. Chrisoperla Carnea - consumes aphids, however, they will also prey on white flits, thrips, and moth eggs. Orius Insidiosus - targets thrips and eggs. Phytoseiulus Persimilis - targets spider mites and juvenile mites. Steinernema Felitae - nematodes, that target fungus gnats systemically. Trichogramma brassicae -targets the eggs of most insect pests, mainly moths and butterflies.
Next, there are plant-derived compounds that repel, kill, or disrupt the life cycles of pests. Pyrethrum and neem oil fall into this category. Then there are such things like diatomaceous earth, which abrades the bodies of flying and crawling pests until they dehydrate and die. Trapping pests is a way to organically control them. Yellow or bright blue sticky traps are necessary to any indoor gardening operation even if it's just for monitoring the buggies. Last, there's no end to the home-remedies: garlic, chili oil, citrus, sesame, coffee, tobacco 'tea'. Other organic methods, which we will use are baking soda and water for the removal of white mold and depriving the plant of light and water if the presence of green mold is detected. GrowSetUp, Inc. and our future Master Grower Nick Tarantino are assuring us that they never had any pest or mold infestation during their growing experience in CEA system. Procedures for proper sanitation practices to minimize plant disease, and to promptly dispose of diseased plant material in a secured disposal area;
When handling the plants employees will have been cleaned head to toe in a clean down room which will be on the premises and they will be wearing laboratory coats , medical gloves, hair nets and shoe coverings that will ensure our cleanliness from dust and stray hair. All processing shall be conducted on a sanitary surface which will be sanitized after every use as well as weight tools and trays. All diseased plants will be disposed of in a trash container located in a concealed room at the facility until a third party service (Police Department) securely removes and has it destroyed pursuant to the rules set by the state of New Jersey Health Department. Our facility will have completely sterile walls and medically sealed floors which lessens any risk of bacteria and pests. Each sector of the facility will have an optimum temperature and environmental control necessary for the maximum production of cannabis. New gloves will always be worn as well as hairnets and coverings for the shoes in the growing areas and packaging room. The CEA helps to eliminate plant diseases. Methods for utilization of fans and cooling systems to maintain airflow patterns sufficient to prevent or minimize plant disease and insect infestation;
FH ATC is going to be running CEA controlled environmental agriculture. Example of maintaining the airflow in the facility to minimize insect infestation: Oscillating air will have an effect on a number of pests that become uncomfortable under a breeze. There are too many varieties of pests that can bring havoc on an indoor Plant Cultivation facility. We can provide one example, perhaps the most common and devastating: the spider Page 74 of 85
mite. This microscopic spider’s metabolism is increased with temperature reducing the time it takes for them to reach sexual maturity. When one is dealing with a population that grows exponentially, it can become beyond control in a short period of time. To shed a little more light on it, a spider mite living in conditions around 45º F will take around 25 days to produce an egg from the time it born. If the temperature is doubled to 90ºF the number of days will fall to about five. As well, the number of eggs that a female can lay will increase as the temperature increases. It all comes back to the temperature/humidity issue. That is the primary reason for moving air in
Plant cultivation facility by circulation Humidity level will be kept unfavorablefans. for fungal diseases. Appendix G: Operation Manual: Controlled Environmental Agriculture on pp. 120-124. Methods to keep environment free from flowering male plants to ensure that female plants are not pollinated and seed production and/or hybridization is prevented;
FH ATC is going to use feminized cannabis seedlings as one of the highest achievements in cannabis farming industry. Feminized seedlings grow into all female plants therefore saving growers from the hassle of identifying and removing the males and thus preventing unwanted pollination. Feminized cannabis seedlings are produced from a chosen cannabis female that has been put through climate stress, which forces the plant to show some male flowers. The pollen is used to pollinate female flowers orderplant, to produce seeds or that do not contain a male chromosome. Theexisting seeds will not grow into in a male only female hermaphrodites. Our growers will make sure that Plant cultivation room is working properly, with automated monitoring and control, and to ensure that all the lights turn on at the same time and turn off at the same time. Watering will be done by a highly integrated drip system. All the factors we have mentioned will ensure that our plants are not induced by excess stress. Since cannabis is very responsive to its environment, big changes in any of the growth factors (light, heat, food, water, etc.) can affect not only the growth of the plant but also potency and even sex. Too much stress will force Hermaphroditism or even a male from a normally female plant. Recordkeeping of any cultural measures used for plant pest or disease control, including disposal of culled plants;
We will ensure that the container of any medicine during any stage in the process of distribution bears an identifying name and number which is known as the ―lot‖ number. The label and bar code will make it possible to determine the complete manufacturing history of the package of organic marijuana. There will be a complete record, stating the measures done for the plant, pest and disease control, and disposal of culled plants. Cultivation staff will keep thorough daily records concerning growth, treatments applied and other information necessary to ensure plants are healthy and medical grade. The various strains of marijuana to be dispensed, and the form(s) in which it will be dispensed Page 75 of 85
According to NJHSS Rules and Regulations, FH ATC Plant Cultivation can grow three strains, with strengths: low, medium and high; and THC limit of no more than 10%.
Our Operation Manual contains at list 5 strains with THC limit of 10%. It will be our growers' decision to choose the best three of them to start growing. Testing will be performed on flowers and leaves prior to packaging to test medicine for potency. (THC limit 10% is allowed by NJHSS) Appendix G: Operation Manual: Pictures and information about the strains on p. 69. How do THC and CBD relate to potency?
The two main components in the marijuana plant (that we know of), which cause its effects on humans, are THC (Δ9-tetrahydrocannabinol) and CBD (Cannabidiol). Some people only pay attention to THC when talking about marijuana "potency" but the story is actually a little bit more complicated than that. As we are studying cannabis, we're learning that CBD actually plays a much bigger role in the overall cannabis experience than we srcinally thought. A recent study indicates thatcited cannabis which areeffect high in do not cause cannabis. the memory impairment which is normally as thebuds biggest side of CBD smoking or using This is big news for patients who would like to use cannabis but do not want any memory side effects. It's becoming apparent that in order to understand the whole picture about the effects of cannabis, we will need to learn about both THC and CBD. THC is the main psychoactive component in marijuana buds. THC appears to help relieve pain and is neuroprotective (helps keep brain from degenerating over time). THC mimics the action of anandamide, which is a naturally occurring cannabinoid in the brain. THC is thought to be the cause of the following effects of cannabis: relaxation, euphoria, altered space-time perception and appetite stimulation.
Page 76 of 85
Having a high THC content by itself does not necessarily mean that the marijuana is great. It's important to look at the whole experience caused by the plant which includes another substance known as CBD. CBD was once thought not to affect the subjective affect of marijuana, but further studies have shown that it actually does have an effect. CBD appears to relieve convulsions, some types of inflammation, anxiety, and nausea. CBD has also been show to help stop the growth of cancer. CBD is also effective as an anti-psychotic for people suffering from schizophrenia. Marijuana buds that have higher amount CBD are a more sedativefor or insomnia calming effect. Cannabis buds athat contain highofamounts ofassociated CBD are with a perfect treatment or for treatment late at night. The best results seem to come from using marijuana that has a mix of both THC and CBD. When used by itself, THC can cause disorientation and anxiety. CBD seems to prevent these effects. The genes of a plant play a big role so it's very important to find a strain which has the effects that you are looking for. Another way to help control the amount of THC and CBD in your plant is to choose the right time to harvest your plant. You can pick the right time to harvest if you watch the trichomes (also known as crystals or resin glands, basically, it's the glittery stuff you see on your marijuana buds). You tend to get the highest overall THC levels if you harvest your plant when all the trichomes are milky /white, or they are half milky and have translucent. If we wait to harvest your plant until 50% or more the trichomes are amber colored, then we will get a final result that has a bit less THC, but more CBD. A simple method to determine when to harvest is to just wait until the buds have only 10% or less total white pistols/hairs. It will be noticed that cannabis buds keeps growing more and more white hairs over the course of the flowering stages, but eventually (it feels like forever) the buds will stop growing new white hairs and 90% or more of the hairs will have darkened. It's hard but waiting to harvest until your cannabis plant has run its whole life course will maximize the CBD levels. This often means keeping your cannabis in the flowering stage for a full 3-4 months. If we allow our cannabis to run its full course, it will maximize CBD levels and our yields. Product Line:
FH ATC will package and dispense medical marijuana only in: 1) Dried form ( 1/4 oz pharmaceutical jars) for direct dispensing to qualifying patients; 2) Oral Lozenges for direct dispensing to qualifying patients; 3) Topical formulations for direct dispensing to qualifying patients. FH ATC will also sell paraphernalia: grinders, vaporizers, auto pipes, and digital scales and microscopes for individual use and quality control. The printed catalog with prices for the products sold in FH ATC dispensary would be prepared for registered patients of FH ATC. There will be the whole information about the strains, their potency, benefits and other possible effects and forms in which medical marijuana is sold in FH ATC. Page 77 of 85
Appendix G: Operation Manual: Pictures of vaporizers, pipes, microscopes, digital scales on pp.77-80. Record keeping for each package by lot, label and bar code
Each plant in FH ATC will be tagged with an inventory control tag when the plant is first transplanted into the vegetative room. Using these control tags (bar codes), the computer will keep track of each plant's individual information. This information will include the strain, batch number, plant number, birth date, projected harvest date and projected yield. 1) To ensure inventory control measures, a barcode system with Radio Frequency Identification Tags (RFID) will be implemented for security and safety. This automated process will provide instant access of any product that has left the facility. The barcode system will be used for small items that have been packaged and are placed in a warehouse inventory management system. 2) The inventory will be moved from the Growing Facility to the Dispensary being bar-coded and tagged. These items will then be recorded in the database system and placed in a secured inventory room (vault). When invoices are generated, each order will be packaged and placed in a sealed container. These items will then be placed into a security storage box with a RFID to track its location. During the entire process of packaging, there will be a minimum of two people who will be present to make certain that procedures are followed properly and signoff and witness that all is safe and secure. In addition, this activity will be video recorded to ensure FH ATC and NJHSS that this process is secure. 3) Inventory that is sold within the Dispensary will be tracked through a Point of Sale system which will automatically transfer information back to the database management system for patient consumption purposes. FH ATC will ensure that the container with cannabis at any stage, starting from growing to distribution, bears an identifying name and number, commonly known as a "lot" or "control" number (bar code), to make it possible to determine the complete manufacturing history of the package of the marijuana. It will permit the identification for purposes of recall of any lot or batch of medical marijuana from registered qualifying patients when such is found to be unsafe to use. Inventory Policies and Procedures
FH ATC will follow inventory controls and procedures designed to prohibit unlawful activity, misallocated material, and employee malfeasance. The goal of our Inventory Control is to ensure all processes are secure and transparent. Transparency will enable FH ATC to provide necessary reports to NJHSS (as required) and reduce the likelihood of employee or 3rd party theft. The Inventory controls are designed so that the product can be measured and documented throughout the entire growth process – from planting, through harvesting, curing, processing and selling. At each stage of the process, the inventory is measured using high-precision scales (calibrated daily) and documented. FH ATC will use the following procedures:
Page 78 of 85
A. Growth Supplies – The Plant Cultivation Manager will inventory all supplies as they are purchased and delivered to FH ATC's facility: lights, plant containers, trays, etc. B. Dispensary Supplies – The Dispensary Shift Manager, will inventory all supplies as they are purchased and delivered to FH ATC's facility: labels, medicine containers, paraphernalia, accessories, etc. C. Raw materials – The Plant Cultivation Manager will inventory all raw materials as they are purchased and delivered to FH ATC's facility: Organic growing medium, Organic plant nutrients and etc. D. Plants – a. The plants will remain in inventory until they reach their useful life and are destroyed. b. Production Plants - Each plant will have a unique identification number and tray assignment. Each tray with plants will be recorded into crop inventory with the strain and identification numbers of the plants in each tray. Each tray will have a unique identification number. The tray will remain in crop inventory until all the plants in the tray are harvested. All plants in a tray will be harvested at the same time. Upon harvest, the marijuana will be removed from the plant, weighed and recorded into inventory as described in section below. The residual plants will be destroyed. Prepared Material (Marijuana)
a. Harvest - As each plant is harvested, a grower will remove the buds from the plant. Harvested marijuana (including stems and trimmings) will be weighed on calibrated scales. Trimmings will be separated and entered into the medicine processing inventory. The marijuana and trimmings will be placed in tamper-evident containers with bank-rated security zip ties in increments of 0.25 oz, having information about the Strain, date of harvest, weight and other necessary information according NJHSS rules and regulations. Once the marijuana is placed in containers, the Plant Cultivation Manager will re-weigh them to verify the weight. Upon verification, he/she will enter the containers into the inventory database and the inventory is physically placed by the officers from the Board of Directors in the vault (fireproof safe with biometric identification). b. Disposal of Plant Stock
i. Upon harvest, each tray will must be inspected by the Plant Cultivation Manager to ensure all useable marijuana has been removed from the plant. ii. Upon verification by the Plant cultivation Manager that the plants are clean of useable marijuana, the stocks will be deposited in trash containers located in the disposable room in the Plant Cultivation facility. iii. FH ATC will contract with a 3rd party service (Police Department) to have the stocks securely removed and destroyed (by combustion) at a licensed waste handling facility. Page 79 of 85
The Director of Operations will receive a copy of all inventory forms so that an independent review of the inventory levels can be checked against the Inventory database sales records. Daily Inventory - All marijuana will be stored in the vault during non-business hours. Each morning and evening, the prepared marijuana at the Grow Operation and the Dispensary will be inventoried by two employees (at least 1 being a supervisor (e.g. Plant Cultivation Manager or Dispensary Manager). Both employees will document and sign an Inventory Tracking form that will be provided to the General Manager who will do an independent reconciliation of these physical inventory forms to the Inventory database and sales records. Any discrepancy will be immediately reported to the Board of Directors. FH ATC will use high-precision scales that will be calibrated daily. All weights must fall within specific tolerances to ensure there is not inventory shrinkage or theft. Our inventory tracking system will alert management when weight fall out of specified tolerances:
Gram must weight 1.03 grams +/- .02 grams Each 1/4 oz. must weigh 7.10 grams +/- 0.2 grams Each oz. must weigh 28.55 grams +/- 0.2 grams All medicine will be dispensed in tamper-evident containers. FH ATC will track the flow of marijuana utilizing trip tickets (Sales Receipts). A copy of the trip ticket will be provided to the patient or caregiver to whom the marijuana is furnished. These records will be maintained for a minimum of six years.
Each container will have a label with the following information: Name of ATC Patient ID number The product (amount and strain) Time and Date of Origin Destination of Product FH ATC Inventory procedures are designed to prevent unlawful activities. In accordance with NJHSS requirements, prepared materials are inventoried daily by two independent employees. Additionally, the General Manager will verify the inventory tracking sheets and provide a daily reconciliation to ensure that all inventory measurements are consistent. Management will conduct periodic, random audits to ensure there is no unlawful activity.
Area security
Future FH ATC area security procedures include four measures: physical, photographic, administrative and accounting: 1) Physical security is fully described in Facility Layout in the Criterion 4, 5, Measure 1 and Measure 2. Physical security will include the construction of a sealed structure (grow room) inside the srcinal facility structure. The whole perimeter of this structure will be reinforced with metal cage. It will provide additional security along with increased quality control for growing the highest grade medical marijuana. Access to the growing facility will require passing through a man-trap leading to a growing room, storage area and workshop area. All the doors will be locked and secured at all times. A state-of-the-art security system will be utilized with a Page 80 of 85
communication configuration notifying law enforcement officials if a break-in or a robbery occurs. In addition, the facility will have a storage vault for keeping the inventory, which will be large enough to contain all inventories for security and quality purposes. The master security alarm will be connected electronically to local police and fire departments, ADT security, U.S. Security Associates Inc and to the officers of FH ATC. Security guards (former police officers) from U. S. Security Associates Inc will work on shifts on the FH ATC facility. They will be equipped with metal detectors and Travel- Positive security system. 2) Photographic system will be a digital surveillance system that is installed inside and outside the facility, which will incorporate the use of infrared security cameras with digital video recorders. This type of system is the more advanced and allows monitoring what is going on in the facility even at night. Also the recordable system will allow FH ATC Directors and monitoring staff of NJHSS to view day-to-day operations of the facility. 3) Administrative surveillance system will incorporate an electronic access control security system. This system protects assets of FH ATC by allowing only authorized personnel into sensitive areas. Each authorized employee will have a personal code, allowing him/her to access critically sensitive areas. This system will restrict employees' movement and serve as another security measure and additional NJHSS's oversight. For security reasons, FH ATC will limit access to medical marijuana growing and storage areas to the absolute minimum number of specifically authorized employees. The Growing facility can only be accessed by 4 persons from the Board of Directors, Master Grower's consultants and two-three Assistant Growers, total of 89 persons. ADT Select Entry Solution will restrict and manage access to Growing Facility. 4) Accounting system will monitor medical marijuana that is harvested, processed and dispensed. Managerial, statistical and operational data will be acquired on different strains to determine their efficiency and also help FH ATC management and NJHSS to conduct performance audits. FH ATC labeling will have information pertaining the date of cultivation, date of harvest, variety and type of the product, quality specifications and weight. This data will help for security and quality control. The future facility is located in the low criminal area in Secaucus, where a lot of substance controlled manufacturers are located. FH ATC facility is located only 1 mile away from local Police department and Fire department. FH ATC security guards' company U.S. Security Associates Inc. is located in front of the facility! Packaging and labeling requirements
To maintain freshness, packaging will take place every week. Cannabis ready for dispensing will be packaged in dark pharmaceutical jars with a limit of weight 1/4 oz., labeled with their inventory control information and barcode, allowing the ATC to track the finished product back to each individual plant which produced it for both security and quality control. FH ATC--plant cultivation will place a legible, firmly affixed label containing the information specified below on each package of medical marijuana. Page 81 of 85
The label required will contain the following: 1) 2) 3) 4) 5) 6) 7) 8)
The name and address of FH ATC; The quantity of the medical marijuana contained within the package; The date that the ATC--plant cultivation packaged the content; A sequential serial number, lot number and bar code to identify lot associated with manufacturing and processing; The cannabinoid profile of the medical marijuana contained within the package, including THC level not to exceed 10 percent; Whether the medical marijuana is of the low, medium or high strength strain; A statement that the product is for medical use by a qualifying patient and not for resale; and A list of any other ingredients besides medical marijuana contained within the package of oral lozenges or lotions.
Labeling shall be clear and truthful in all respects and shall not be false or misleading in any particular. A label containing any statements about the product other than those specified will contain the following statement prominently displayed, and in boldface type: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
FH ATC proposed label would be submitted to NJHSS for the approval. Appendix G: Operation Manual: Label Sample on pp. 39-41. Methods of processing in a safe and sanitary manner
FH ATC will take all serious precautions to ensure that our patients are receiving the purest and safest cannabis medicine, and lozenges, oils and lotions infused with medical marijuana. All employees, who access Plant Cultivation facility, have to pass through a clean room and require washing and changing into clean protective suits, which can also prevent the growing facility from contamination by bacteria, fungi or insects. To prevent from contamination, FH ATC developed Quality Control Policies: 1) 2) 3) 4) 5) 6)
All processing shall be conducted on a sanitary surface; All weight tools, trays and surfaces shall be sanitized after each use; Laboratory coats shall be worn by processing/packaging staff; Hairnets and beard nets (if necessary) shall be worn whenever inside the Processing and Packaging room; Cultivation staff will wear single-use shoe coverings and other protective gear in the growing areas to prevent introduction of contaminants on the clothing/shoes; New gloves shall be worn whenever medicine is being handled (New medicine=New gloves);
Page 82 of 85
7)
8) 9)
All manufacturing site staff shall be trained in identification and removal of contaminants on cannabis grown by FH ATC. Contaminated medicine will be subtracted from inventory and isolated for further analysis, testing and disposal; A magnification device, preferably a digital magnascope, shall be available to identify contaminants; Cultivation staff will keep thorough daily records concerning growth, treatments applied, and other information necessary to ensure plants are healthy and medical grade;
10) Animals shall never be allowed inside the grow facility. FH ATC will have a food safety certified experienced handler, who will be on the kitchen staff. He/she has to be familiar and demonstrate knowledge of FDA's Food Code to protect consumers' health. Regular inspections and stringent policies will ensure a safe, standard, healthful range of products for our clients. FH ATC Director Ida Umanskaya has a patent in medical marijuana industry .Her patented method and formulation, developed by a professional laboratory, will provide the safest and most efficient transcutaneous cannabinoid delivery. It will be FDA registered. FH ATC will buy the highest density plastic double-wall bottles from NJ Company Ispec Inc. FH ATC's protocols for production and packaging include rigorous standards for quality control and testing, batch production records, product release specifications, labeling, ingredients, safe storage and disposal, and sanitation. FH ATC will buy packaging from Medical Marijuana Bottles Inc, which is selling FDA approved bottles, highest possible quality plastic, Odor-free, Water-proof, UV-resistant and even Child-proof (www.medicalmarijuanabottles.com). FH ATC will take seriously our obligation to prevent the transmission of food borne illnesses (through the use of oral lozenges) to all our registered patients, and professionally produce cannabis-infused products. People, working with Oral Lozenges have to go through tuberculosis screening. In the future, FH ATC is expecting to build a small laboratory on its premises which will be capable of performing cannabinoid and contamination analysis of all our medicine. As a part of quality control, our system of recordkeeping, which was described earlier, will permit the identification for purposes of recall of any lot or batch of medical marijuana from registered qualifying patients when such is found to be unsafe to use. FH ATC Officers hope that such accidents would never occur in our operation. FH ATC--plant cultivation shall process marijuana in a safe and sanitary manner to protect registered qualifying patients from adulterated marijuana and shall process the dried leaves and flowers of the female Marijuana plant only, which shall be: 1) Well cured and free of seeds and stems; 2) Free of dirt, sand, debris or other foreign matter; and 3) Free of mold, rot or other fungus or bacterial diseases. Page 83 of 85
Medical marijuana shall be packaged in a secure area connected to the production area. A special room for packaging of usable marijuana will be connected to the growing room. Please, see the floor plan. Packaging process will be handled at least once a week to ensure freshness and quality of the product in the package. 1) The dried product shall be handled on food grade stainless steel benches (tables). 2) Proper sanitation shall be maintained. 3) Proper rodent/bird exclusion practices shall be employed at all times. Each package of usable marijuana, at a minimum, shall: 1) Contain no more than 1/4 ounce of marijuana or equivalent dose dependent on form; 2) Bear a label that complies with N.J.A.C. 8:64-10.7; 3) Be in a closed container that holds no more than 1/4 ounce and sealed, so that the package cannot be opened, and the contents consumed, without the seal being broken. Once a package is sealed, the ATC shall not open the package except for quality control. Once the seal is broken at an ATC, the marijuana is deemed unusable. The ATC will submit the label to MMP for approval and record. The MMP shall provide a copy of the label to authorized employees of State or law enforcement agencies, as necessary to perform official duties of that department and that division. NOTE: OFFICIAL USE ONLY – SECURITY-RELATED INFORMATION – WITHHELD PURSUANT TO THE NEW JERSEY OPEN PUBLIC RECORDS ACT (OPRA)
Page 84 of 85
