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New Jersey Department of Health & Senior Services

Medicinal Marijuana Program

Application to Establish and Operate a


Medicinal Marijuana Alternative Treatment Center

SOUTHERN REGION
New Jersey

Submitted February 14, 2011 by


Compassionate Sciences ATC, Inc.
Our mission at Compassionate Sciences ATC is to establish in the Southern Region of
New Jersey a medical model of care that sets a national standard consistent with the
compassionate principle, legislative intent and public policy vision that animate the New
Jersey Medicinal Marijuana Program. We intend to accomplish our mission by:

• Serving the population of medical Cannabis patients exclusively


• Producing and dispensing Cannabis like a medicine, to pharma-quality standards
• Optimizing supply chain control and transparency, from seed to patient

Our research has shown that many if not most existing models across the country are, to
varying degrees, failing to meet the needs of bona fide patients and their physicians while
creating unintended public policy problems. Compassionate Sciences was founded in the
belief that there is a manifest need for clinically-appropriate, physician-driven and well-
regulated palliative care as envisioned by the State of New Jersey.

We are committed to creating the nation’s first pharma-standard model of palliative care
in New Jersey, the capitol of the U.S. pharmaceutical industry. To that end, we have
brought together a uniquely-qualified team from business, health care, science and
agriculture -- including a CEO who introduced a break-through oncology treatment and a
pharmacologist who heads the George Washington University Cancer Center.

If awarded a permit, Compassionate Sciences will work diligently within the Medicinal
Marijuana Program to meet the needs of all stakeholders including patients, physicians,
primary care givers, government officials, regulators, law enforcement and the
communities of the Southern Region of the State.

We commend New Jersey officials and the Department of Health and Senior Services for
your leadership in setting the standard for a genuine medicinal model of palliative care
and we greatly appreciate the opportunity to contribute to your success.

Sincerely,

Richard Taney, Chief Executive Officer


Compassionate Sciences ATC, Inc.
New Jersey Medicinal Marijuana Program
ATC Application Cover Sheet & Attestation Statement

Applicant Compassionate Sciences ATC, Inc.

Contact Person Richard Taney, CEO

Address 252 Sea Cliff Avenue


Sea Cliff, NY 11579

Telephone 516-304-5130

e-mail Richard.taney@gmail.com

Attestation Statement:

I hereby attest and certify to the accuracy and veracity of all statements, figures, amounts
and other information incorporated within the application and materials hereby submitted.

Compassionate Sciences ATC, Inc.

By:

Richard Taney
Chief Executive Officer

February 14, 2011


NEW JERSEY MEDICINAL MARIJUANA PROGRAM

Application to Establish and Operate a Medicinal Marijuana


Alternative Treatment Center

CRITERION 1: SUBMISSION OF REQUIRED INFORMATION REGARDING


APPLICANT & FACILITY

Measure 1: The applicant shall provide the proposed legal name and the following
documents applicable to the applicant’s legal status.

Compassionate Sciences ATC, Inc.

Please see Appendix A for:

• Certificate of Incorporation
• Certificate of Good Standing
• Corporation by-laws

Measure 2: The applicant shall provide the proposed physical address(es) of the
ATC, if a precise address has been determined. If a precise address has not been
determined, the applicant shall identify the general location(s) where the facilities
would be sited, and when.

Management of Compassionate Sciences (“CS-ATC”) commissioned a real estate survey


to identify general locations in the Southern Region service area. The survey was
conducted by CB Richard Ellis, a global leader in real estate services with an experienced
team in New Jersey.

The CBRE survey identified general locations in which to site a secure, high tech facility
converted to accommodate cultivation, packaging and dispensing of medicinal Cannabis
in keeping with the rules of the New Jersey Medicinal Marijuana Program and the New
Jersey Compassionate Use Marijuana Act.

While designed to identify general locations, the survey also produced a preliminary list
of potential sites within each location as a first step toward establishing a precise address
for CS-ATC pending the Department’s award decisions.

Please see Appendix B for a map of general locations.

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Compassionate Sciences is prepared to identify and secure a precise location immediately
upon receiving a favorable award decision from the Department. As indicated, we have
targeted potential sites based on criteria that meet the requirements of the NJMMP and
the needs of the organization. Management has engaged CBRE to standby in preparation
to select the optimal facility and promptly secure occupancy for CS-ATC.

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).

The survey conducted on behalf of Compassionate Sciences included a site analysis


based on the following zoning and area criteria:

• Outside school and other drug free zones


• Not situated in residential neighborhoods
• Technology or industrial areas
• Light industrial or flexible-use zones

Based on the survey, and in consultation with CBRE, management believes that local
zoning rules in our targeted locations will not preclude occupancy or filing of appropriate
variances to operate an ATC.

Please see Appendix C for a list of potential sites in the Southern Region.

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.

Throughout our survey of potential locations, Compassionate Sciences made community


safety and finding appropriate, discreet, non-residential locations our top priority. A site
analysis screen was used to identify only those locations that fell outside of school and
other drug-free zones. As a result, potential sites for CS-ATC are at least 1,000 feet from
the nearest school, day care center or place of worship.

Please refer to our site analysis maps in Appendix D.

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Measure 5: The applicant shall provide a legible map or maps of the ATC service
areas by Zip Code.

The CS-ATC service area in Southern Region is represented by the map in Appendix E.

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.

Our mission at Compassionate Sciences is to establish a facility and product that meets a
pharma-standard of palliative care. We believe that that the key to our success is in the
quality of our team. We have brought together a uniquely-qualified group of executives
and trustees with extensive experience in business, health care, science, agriculture and
the non-profit sector. CS-ATC management intends to recruit a staff of similarly
accomplished and motivated individuals at every level of the organization.

Compassionate Sciences ATC Senior Management Team

Richard Taney, Chief Executive Officer. Mr. Taney is a chief executive with
extensive experience in health care, medical technology and financial services. Mr.
Taney assumed leadership of Compassionate Sciences after serving as CEO of
Delcath Systems, Inc., (NASDAQ: DCTH), a medical technology company that
developed a patented system for the targeted delivery of ultra-high dose
chemotherapy to the liver for treatment of a variety of cancers. Under his leadership,
Delcath Systems achieved widespread adoption by doctors and hospitals. Mr. Taney
is also a Trustee of the Compassionate Sciences ATC.

Jack Burkholder, Chief Financial Officer. Mr. Burkholder is a consultant with


more than 30 years of experience in international investment banking, corporate
finance and real estate development. He has an expertise in managing complex
projects involving close cooperation with governments at all levels and has served
extensively in the public trust as a court-appointed receiver. Mr. Burkholder is active
in his community as a member of the Real Estate Roundtable and the audit committee
of his local school district. He graduated with a BS in Agriculture from Cornell
University. Mr. Burkholder is also a Trustee of the Compassionate Sciences ATC.

Michael Nelson, Chief Operating Officer. Mr. Nelson is the founder of a highly
successful international outfitting business who is also the owner and operator of one
of the largest and most respected ATC’s in Montana. As a grower-operator over the
last six years, he has developed experience in the building of ATCs, systems design,
ATC employee orientation and training and management. Mr. Nelson’s cultivation
center and multiple-location dispensaries have set a standard of excellence in serving
qualified patients throughout the Central and Western regions of the State. Mr.
Nelson brings to his work a background in sales, management, distribution and
marketing of school products to universities and high schools across the American
Northwest. He is active in the Bozeman area business community and as a volunteer

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in a sports program for the disabled. Mr. Nelson earned a BS in Business from the
University of Colorado.

Nicole Wagner, Master Grower. Ms.Wagner is an accomplished government and


academic analyst and researcher in the fields of sustainable agriculture, ecology,
agronomy, statistics, engineering and economics. With an expertise in global and
domestic agricultural policy, she has served as an international economist and crop
assessment analyst at the U.S. Department of Agriculture as well as a researcher at
Montana State University. Ms. Wagner has published numerous research studies and
has a deep understanding of diversified agricultural systems including organic
vegetable and dairy production, conventional corn, soybean, and small grains
production. She is also a director of the non-profit Community Food Alliance and
works with Field Day Farms, a Community Supported Agriculture (CSA) farm that
supports 30 families. Ms. Wagner earned her PhD. in Land Resources and
Environmental Sciences from Montana State University and attended the University
of Minnesota where she earned her Masters and BA in Biosystems and Agricultural
Engineering. She developed her expertise as head grower at the Mr. Nelson’s
medical Cannabis facility in Montana.

Andrei Bogolubov, EVP of External Affairs. Mr. Bogolubov is a communications


professional who has served government, major multinationals, regional and
emerging growth companies in a wide range of industries around the world. His
expertise is in public affairs, business development and community outreach. Mr.
Bogolubov’s healthcare, medical and pharmaceutical clients have included American
Home Products, Bristol Myers Squibb, Columbia Presbyterian Hospital, Medical
Excellence, The Michael J. Fox Foundation, Pfizer, Pharmacia & Upjohn and
ValueOptions. He also has served in government as Assistant to the Secretary for
Public Affairs at the US Department of the Interior where he was also the
Department’s public affairs liaison to the White House. Mr. Bogolubov developed
his expertise in community relations as Director of Policy & Communications at a
major national grassroots citizens lobby. Mr. Bogolubov began his public sector
career on the committee staff of the Connecticut State Legislature and later served as
an aide to a US Congressman.

Noel Palmer, Chemist (consultant). Dr Noel Palmer is a respected chemist with an


expertise in plant and soil chemistry. He is skilled in chromatographic and
spectroscopy methods, specializing in the detection of heavy metals, pesticides, and
herbicides in both soil and plant matter. He received his doctorate in analytical and
soil chemistry from the University of Idaho. The focus of Dr. Palmer’s work was
applying various analytical methods to look at soil systems and humic materials and
their interactions with various inorganic compounds. Earlier, he managed a soil
research lab at the University of Idaho. Dr. Palmer brought his skill in performing
chromatographic separations to the analysis and study of Cannabis chemistry. He is a
member of the board of the Alliance for Cannabis Science, an international
community of Cannabis scientists. Dr Palmer is also the lab manager for Montana
Botanical Analysis, a research lab in Montana focused on the study of Cannabis

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chemistry. His research has been published in more than 10 peer-reviewed scientific
papers.

Compassionate Sciences Trustees

Webster B. Todd, Jr. Mr. Todd brings to Compassionate Sciences experience,


judgment and insight he developed over the course of a distinguished career in
government, politics and commercial aviation. As a public servant, he was a member
of the White House staff and the New Jersey General Assembly as well as a State
Department official and the Chairman of the National Transportation Safety Board.
Among his private sector achievements, Mr. Todd was the founder of Princeton
Aviation Corp, Senior Director of Air Safety at the Airline Pilots Association and
President of Frontier Airlines. Throughout his career, Mr. Todd has been active in
the community including service as a Director of the New Jersey Commerce and
Economic Growth Commission, a member of the Tewksbury Township Agricultural
Advisory Board and as a New Jersey firefighter.

Dr. Steven Patierno. Dr. Patierno is a leader in the science and medicine of cancer
who is Executive Director of the George Washington University Cancer Institute. He
also serves as Vivian Gill Distinguished Professor of Oncology, GW School of
Medicine; Professor of Pharmacology & Physiology, Genetics & Urology, The GW
School of Public Health & Health Services; Health Sciences Professor of
Environmental & Occupational Health; and Founding Director of the Molecular &
Cellular Oncology Program. Dr. Patierno has over two decades of experience
managing over $30 million of grants including large, complex biomedical research
grants (both laboratory and population sciences), as well as community-based grants
in cancer disparities, prevention and control, education and outreach, and
survivorship.

Dr. Patierno is also an accomplished teacher who was been the recipient of the GW
Medical Student’s Golden Apple Award. He is the principal mentor to 20 Ph.D.
graduate students and Program Director to over 50 graduate students as well as 20
postdoctoral fellows, medical residents and undergraduate trainees. Dr. Patierno
earned his PhD in pharmacology at the Graduate School of Biomedical Science at
University of Texas Health Science Center in Houston and the MD Anderson Cancer
Institute where he was awarded the prestigious Rosalie B. Hite Graduate Fellowship
in Cancer Research for his work on the genetics of cancer causation.

Please refer to Appendix F for:

• A list of Compassionate Sciences officers, staff members and Trustees with


required information.
• Management and trustee biographies

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Measure 7: Disqualifying Drug Offenses

Existence of Disqualifying Offenses by Applicant, Principals, Officers, Trustees Yes No


or Partners

Convictions under any Federal, state or local laws, relating to drug samples,
wholesale or retail distribution, or distribution of a controlled substance 

Felony convictions under any Federal, state or local laws 

Experience in manufacturing or distribution of drugs or controlled substances 

Furnished false or fraudulent material in any application concerning drug 


manufacturing or distribution

Whether applicant is in compliance with any previously granted professional health n/a
license or registration

Measure 8: The applicant shall provide the identities of all its creditors, if any.

Compassionate Sciences has a single creditor,

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.

Persons & Entities with Authority Over ATC Management & Policies
Richard Taney Chief Executive Officer & Trustee
Jack Burkholder Chief Financial Officer & Trustee
Mike Nelson Chief Operating Officer-Horticultural and Dispensary
Andrei Bogolubov Executive Vice President – External Affairs
Nicole Wagner Master Grower
TBD Vice President– Security Systems
Webster B. Todd, Jr. Trustee
Dr. Steve Patierno Trustee

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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.

Not applicable.

Measure 11: Application cover sheet and attestation statement

Please refer to the executed application cover sheet and signed attestation statement
exhibited at the front of this document.

CRITERION 2: SUBMISSION OF REQUIRED ATC OPERATIONAL


INFORMATION

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. Supporting
documents should be included as Appendix G.

Please see the draft CS-ATC operations manual in Appendix G.

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:

The proposed New Jersey medical Cannabis growing facility and dispensary will be
owned and operated by Compassionate Services ATC, Inc. (“CS-ATC”), a registered
New Jersey nonprofit organization. CS-ATC was formed by business people with many
years of successful experience in creating and managing new companies – including
developing economically viable business and marketing plans, securing favorable debt
and equity financing from private and commercial institutions, and operating the
companies in a financially profitable manner. Together, the founders of Compassionate
Sciences have raised more than $100 million in equity and over $2 billion dollars in debt
for companies in a variety of industries including medical technology and devices,
agriculture, manufacturing, and real estate.

In addition to the broad experience brought to Compassionate Sciences by the founders,


CS-ATC’s financial and business operation, as set out in its business plan, will be
overseen by a Board of Trustees comprising five individuals. Each trustee brings to the
board expertise and knowledge unique to the understanding and successful management
of not-for-profit businesses, as well as industry specific expertise in medical science,
biology, oncology, agricultural finance and economics, and forensic and management
accounting. Our Medical Advisory Board, comprised of five prominent individuals from
the medical community, will compliment the strength of the trustees and enhance our

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ability to grow, manufacture and deliver superior, high-quality palliative products for our
patients.

I. Question: The applicant shall provide a detailed description about the amount and
source of the equity and debt commitment for the proposed ATC.

Financing for the Compassionate Sciences will be provided by

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CRITERION 3: COMMUNITY INPUT - DESCRIBE THE ATC PLANNING
PROCESS AND INVOLVEMENT OF COMMUNITY STAKEHOLDERS IN
DETAIL. DESCRIBE REMAINING STEPS IF ANY TO RECEIVE NECESSARY
APPROVAL FOR SITE LOCATION OR OPERATIONS.

Measure 1: Input from the city(s) or town(s) where the applicant’s ATC would be
located.

(see below)

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.

(The following response applies to Measure 1 and 2 above)

The Compassionate Sciences will conduct an active community outreach program that
will begin simultaneously with the local zoning process and continue through build-out,
occupancy, the start of ATC operations and beyond. Our community relations effort will
be grounded in the principles of openness, inclusive stakeholder engagement and social
responsibility. Compassionate Sciences is committed to being a good neighbor and to
making a positive contribution to the communities across our service area.

Upon identifying an ATC location, we will promptly meet with local zoning and other
public officials to get their input. We will also seek their guidance on the best
opportunities to obtain feedback from the general public and local communities regarding
the ATC site and other areas of public interest. Compassionate Sciences management is
prepared to attend, and present at, appropriate public forums or to facilitate a townhall-
style meeting to answer questions and get local input into our planning process, if
requested.

At the outset of our relationship with the community, an important objective will be to
introduce ourselves, the organization and our operating plans and principles. However,
the primary purpose from day one and ongoing will be to listen and respond to any issues
and concerns of local leaders, law enforcement authorities, community groups, the
general public and particularly our neighbors.

Our commitment to community engagement begins at the top with the involvement of
CEO Richard Taney and the program will be managed by Senior Vice President for
External Affairs Andrei Bogolubov, a veteran communications professional with
experience in designing and executing public affairs outreach programs for businesses
and non-profits including healthcare, medical and pharmaceutical industry organizations.

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Our approach to community relations is expansive and the Compassionate Sciences
public affairs program will engage all stakeholders including:

• ATC neighbors and community groups


• Businesses and commercial associations
• State and local law enforcement
• Government officials at the town, city, county and State levels

In keeping with our mission to set the standard for a medical model of palliative care, the
CS-ATC Medical Advisory Board will oversee the organization’s outreach to the medical
and healthcare community in our service area. Led by Medical Advisory Board
Chairman Dr. Steven Patierno, we will engage stakeholders including:

• Doctors, medical and healthcare organizations


• Academic and research organizations
• Local representatives of community, State and national organizations such as:
- The New Jersey Hospice & Palliative Care Organization
- New Jersey Pain Initiative
- Medical Society of New Jersey
- New Jersey Hospital Association
- UMDNJ
- The Cancer Institute of New Jersey, etc.

Compassionate Sciences management believes that New Jersey can set the national
standard for clinically-appropriate, physician-driven and well-regulated palliative care.
We are committed to contributing to the success of the New Jersey Medicinal Marijuana
Program. To that end, we will be in regular contact with the Department of Health and
Senior Services, the NJMMP and our ATC counterparts to collaborate on issues of
management, clinical practice, research, science, public policy and community interests
in our industry.

The organization will commit ATC resources to support our public outreach program.
Mr. Bogolubov will be provided a budget to carry out a comprehensive community
relations program. Our database will record and analyze community comments and
feedback. In addition to providing neighbors with an ATC point of contact as required by
the NJMMP, we will provide contact information and channels for non-emergency input.
CS-ATC staff performance reviews will include a community relations component.

The trustees and the Medical Advisory Board (MAB) will regularly review the program
and make recommendations. The MAB will lead our program of reporting the latest
clinical and scientific advances to qualified patients who register for such updates, and
we will share this information with our industry colleagues. Finally, Compassionate
Sciences is committed to establishing a philanthropic component as soon as possible with
a focus on supporting the advancement of pain management, palliative research and
addressing indigent healthcare needs.

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CRITERION 4: DISPENSARY SPECIFIC CONSIDERATIONS

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].

A medical standard of data management is at the heart of the Compassionate Sciences


model. We will put in place the personnel and tools required to create a secure body of
data that will enable the CS ATC to advance the clinical practice and science of palliative
care while providing rigorous internal controls and excellent patient service.

CS Trustee John Prufeta will bring expertise to this process as the former CEO of a
pioneering medical data company. We will also benefit from the extensive experience of
Trustee and CEO Richard Taney, who was the chief executive of an FDA-regulated
medical device company. In addition, Trustee and Medical Advisory Board Chairman
Dr. Steven Patierno, a pharmacologist and Executive Director of the GW Cancer Center
will provide oversight and guidance in developing and implementing our data
management protocols.

Compassionate Science will employ state-of-the-art technology to deploy a secure,


HIPAA-compliant data management system that meets our exacting standards and those
of the NJMMP. At the core of the system is a proprietary software platform which was
designed, tested and refined in a successful and well-established growing/dispensing
facility in Montana.

The system, which tracks and records every aspect of ATC operations from patient
information to sales to the entire production cycle from seed to patient, includes a robust
patient outcome, utilization and trend analysis capability. The software will be adapted
to the specific requirements of the CS-ATC, the NJMMP, local law enforcement and all
governing regulations under the supervision of John Prufeta, Compassionate Sciences
executives and the ATC’s head of security.

All dispensary employees will be trained in CS-ATC data, privacy and security protocols.
Compliance will be a condition of employment and reflected in performance reviews.
All patient information will be input into the secure, encrypted database which will be
backed-up in keeping with accepted data security practices. Any paper documents will
be stored in a locked cabinet with access restricted to authorized personnel and a record
of access maintained by the system. Data security records and practices will be reviewed
regularly by the ATC’s head of security and the CEO, with reports generated for the
Board of Trustees as a basis for their annual assessment.

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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.

At the center of a medical model of care is a relationship with patients that provides the
information and counsel they require to follow a beneficial course of treatment as
recommended by their physicians. Compassionate Sciences intends to establish the
highest standard of excellence in our patient education and counseling program. The
program will be designed and supervised by Dr. Steven Patierno, the Chairman of the
Medical Advisory Board (MAB). Dr. Patierno will bring to the program his expertise in
consulting with patients at the GW University Cancer Center as well as his background as
an accomplished educator with extensive publishing credits.

Our experienced patient counselors will provide every qualified patient with the
knowledge and tools they need, along with informative materials to take home. The
process will begin with the basics in an intake interview. The counselor will provide
background on Compassionate Sciences, ATC procedures, rules of the New Jersey
Medicinal Marijuana Program and State laws governing the program. Patients will learn
about their rights and responsibilities as well as registration, payment and financial
assistance procedures. The patient’s information will be collected including doctor,
physician registration, recommendation and other data required by the NJMMP. Patients
will have the opportunity to discuss their condition and complete a pain self assessment.

Compassionate Sciences counselors will be trained to provide accurate, timely


information and sensitive counsel. All patients will be informed of the efficacy, side-
effects and addictive qualities of Cannabis and will be provided with information about
signs of addiction as well as resources for recovery. Information covered in the intake
counseling session will be supported by written materials in a patient orientation package
that will also include FAQs, basic contact information and resources for further
information. The packet will also include forms as well as procedural checklists and
reminders.

Registered patients will also receive educational counsel and materials. Compassionate
Sciences will produce a full spectrum of counselor scripts and brochures to inform
patients of issues such as diseases, treatments and conditions, Cannabis as a medicine,
methods of administration and the state of palliative science. Patients will also be invited
to register for alerts about the latest developments in the research and clinical
development of Cannabis-based palliative therapies, as well as related issues.

Compassionate Sciences staff will actively monitor the latest news under the supervision
of the MAB and update counseling protocols and materials on a regular basis.
Excellence in education and counseling will be a focus for the organization in terms of

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training and performance reviews. The trustees and the MAB will periodically assess and
make recommendations to improve the program.

Please see the Appendix entitled Education for an overview of the program and sample
materials.

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.

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Measure 5: The applicant shall submit a description of its Medical Advisory Board,
including by-laws, setting forth the names and expertise of its members and
describing how it will function within the organizational structure of the ATC,
consistent with the Rules Related to the Medicinal Marijuana Program. For
purposes of this requirement, it is not necessary to provide the name of the Medical
Advisory Board member who is a registered qualifying patient.

Compassionate Sciences views our Medical Advisory Board (MAB) as central to the
organization’s commitment to serving the varied needs of qualified patients enrolled in
the New Jersey Medicinal Marijuana Program. An accomplished and engaged MAB is
also part and parcel of our mission to set the national standard for a medical model of
care consistent with New Jersey Compassionate Use Marijuana Act by:

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• Serving and informing medical Cannabis patients and their physicians
• Producing and dispensing Cannabis like a medicine, to pharma-quality standards
• Advancing the clinical practice and science of Cannabis-based palliative care

Organization

The Compassionate Sciences MAB will be composed of five members, who will be
appointed based on their knowledge and leadership in the specialized fields of
knowledge:

• Medical oncologist
• Pain management expert
• Pharmacologist
• Patient advocate (registered qualifying patient)
• Psychologist or a physician with expertise in drug addiction
• Ex-officio NJMMP representative will be invited to attend the MAB meetings

The MAB will be comprised of distinguished experts who will help design, support and
improve services offered by CS-ATC to meet the evolving needs of the medical Cannabis
patient community. Our Medical Advisory Board will be recruited and chaired by Dr.
Steven Patierno, a leading pharmacologist and head of the GW Cancer Center as well as a
Trustee of CS-ATC (please see Dr. Patierno’s biography in Appendix F).

The Compassionate Sciences MAB will have broad responsibility to:

• Engage with CS-ATC management in an advisory capacity to advance its mission


of delivering safe, effective palliative care to qualified patients.
• Conduct initial review and periodic updates of ATC policies to assure compliance
with the New Jersey Compassionate Use Medical Marijuana Act.
• Review and comment on the ATC’s proposed initiatives and ongoing activities.
• Assist in formulating recommendations to improve or advance implementation of
CS-ATC programs and policies relating to palliative therapies and patient
education.
• Apprise management and patients of new developments in the science and clinical
practice of Cannabis-based palliative care and related issues.

A major focus of the Compassionate Sciences Medical Advisory Board will be


continuing education programs that inform qualified patients pursuant to the rules of the
NJMMP. In this regard, the MAB’s expertise in drug addiction and prevention will be of
critical importance. The board will also direct the substance and timing of notifications
to qualified patients who register to receive scientific and clinical alerts in keeping with
the rules of the NJMMP.

As part of our commitment to public service, we will work with our MAB experts as well
as local healthcare and community leaders to design a targeted and effective plan to reach
the broadest patient population and the community consistent with the rules of the

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NJMMP. As the patient population grows, there will also be a need to increase
awareness of the special needs of our patients and their families among the region’s
primary, secondary and critical care facilities. The MAB’s physician members will assist
in designing that outreach and will assist us in engaging those institutions. As the
NJMMP program grows, the data and knowledge base on consumption patterns,
conditions treated and patient preferences will increase research and analysis
opportunities to the benefit of all stakeholders.

The data collected by CS-ATC will be reviewed annually by our MAB to identify areas
of improvement in our services and to address, and make recommendations on, any
patterns or deficiencies that might be uncovered during their review. This data and
analysis will be shared with NJMMP representatives to assist them in analyzing the
effectiveness of the program in meeting its stated objectives and legislative intent.

Measure 6: The applicant shall submit a plan to track and analyze data including
but not limited to patient outcome, utilization and trends.

The advance of medical science was greatly accelerated with the advent of computers,
sophisticated analytical technologies and powerful data bases. Compassionate Science
has placed an organizational emphasis on developing robust data and IT systems. The
organization has put in place the personnel and tools required to create a secure body of
data that will enable CS-ATC to provide exceptional patient care, data security and
privacy while also delivering rigorous supply chain control throughout the production
chain.

Compassionate Sciences Trustee John Prufeta brings expertise to this process as the
former CEO of a pioneering medical data company. We will also benefit from the
extensive experience of Trustee and CEO Richard Taney, who was the chief executive of
a FDA-regulated medical device company. In addition, Trustee and Medical Advisory
Board Chairman Dr. Steven Patierno, a pharmacologist who heads the GW Cancer
Center, will provide oversight and guidance in developing and implementing our data
management protocols.

Compassionate Sciences will employ state-of-the-art technology to deploy a secure,


HIPAA-compliant data management system that meets our standards and those of the
NJMMP. At the core of the system is a proprietary software platform which was
designed, tested and refined in a successful and well-established growing/dispensing
facility in Montana.

The system, which tracks and records every aspect of ATC operations from seed to
patient, includes a robust patient outcome, utilization and trend analysis capability. The
software will be adapted to the specific requirements of the CS ATC, the NJMMP, local
law enforcement and all governing regulations under the supervision of Trustee John
Prufeta and Compassionate Services executives.

21
CRITERION 5. CULTIVATION SPECIFIC CONSIDERATIONS

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.

22
23
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. If the enclosed site is a greenhouse, identify materials used in
construction of panels. Glass, fiberglass, metal, or polycarbonate panels shall be
used in construction of the facility; polyethylene film is not permissible. Describe
window and vent covers.

24
Measure 3: The applicant shall demonstrate an ability to provide a steady supply of
medicinal marijuana to registered qualifying patients.

Based on our experience, the keys to producing consistent, high quality medicinal
Cannabis in keeping with State specifications are the following:

1. Experienced cultivators. The single most important asset will be the ATC’s
growers. As a plant that must be grown indoors to strict environmental tolerances
without the use of pesticides, Cannabis is vulnerable to infestation, mold, disease and
other blights that can destroy a harvest and interrupt supplies to patients in need. The
record is clear -- even experienced agronomists with access to readily-available
literature on cultivating Cannabis have failed to produce a usable first harvest.

In this respect, the NJMMP and any other new medicinal marijuana program across
the country faces challenge inherent in the lack of local experience in cultivation.
Moreover, the experience in California and Colorado demonstrates that there is a
relatively limited pool of first-rate growers across the country. CS-ATC management
has conducted an exhaustive national search to identify and secure the services of
cultivators with the necessary credentials. We are confident that CS-ATC’s COO,
Michael Nelson, and Master Grower Nicole Wagner have the credentials and track
record that are second to none.

2. State-of-the-Science Environmental Controls. Holding experience constant, the


next priority in successful cultivation is the ability to control the vital environmental
factors of light, temperature, water and air quality. CS-ATC will install and maintain
the best lighting, HVAC, irrigation, sensor, backup generation and other critical
systems to ensure that we are able to consistently nurture generations of healthy
plants throughout their growing cycle.

In addition, CS-ATC will build a cultivation area consisting of ten smaller grow
rooms instead of one large growing floor. A multi-room design helps insure against a
catastrophic supply disruption stemming from an infestation or disease because minor
outbreaks are easily isolated and treated in the room of origin, greatly mitigating the
risk of epidemics. Also, a series of smaller affords the ability to sanitize completely
after harvests, a safeguard that is not available in an open floor design. This approach
also ensures a regular harvest every 7-10 days as the rooms produce crops in a
staggered cycle.

25
Please see the Site and Room Provisions in Appendix H for a detailed engineering
overview.

3. Rigorous Quality Management and Controls. CS-ATC will place primary


emphasis on management to achieve the quality standards of the NJMMP. We know
of many instances in which the best-available quality control systems have not
guaranteed results due to the lack of diligent management by an experienced and
dedicated cultivator. At the same time, quality controls are essential tools in any
growing operation and CS-ATC’s system consists of four components which are
described in Measure 3 (III) below.

I. Question: 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.

Compassionate Sciences enjoys a significant initial-stage operating advantage that


comes from having a COO with the experience of successfully building and
launching multiple ATC facilities including growing and dispensary operations in
Montana. We have designed our operational launch timetable based on Mr. Nelson’s
experience supplemented by consultation from our New Jersey-based commercial
real estate advisors at CB Richard Ellis.

CS-ATC Start-Up Timetable

Issuance of Authority to Building Permit 1 month


Building Permit to Limited Occupancy 3 months
Building Permit to Full Occupancy 5 months
Occupancy to Limited Operations 2 months
Occupancy to Full Operations/Cultivation 3 months
Issuance of Authority to Full Operations/Cultivation 9 months

The above timetable assumes that the building department issues our permit within
four weeks of application. Construction is estimated at five months, and an additional
nine week period is required from limited occupancy when cultivation begins to first
harvest.

II. Question: 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.

Compassionate Sciences cultivators have deep experience in agricultural growing


methods including organic practices:

Michael Nelson, Chief Operating Officer. Mr. Nelson is the owner and operator of
the largest and most respected ATC’s in Montana. His cultivation center and
multiple-location dispensary has set the standard of excellence in serving qualified

26
patients throughout the Central and Western regions of the State. Mr. Nelson brings
to his work a background in sales, management, distribution and marketing of school
products to universities and high schools across the American Northwest. He is
active in the Bozeman area business community and as a volunteer at a sports
program for the disabled. Mr. Nelson earned a BS in Business from the University of
Colorado.

Nicole Wagner, Master Grower. Ms.Wagner is an accomplished government and


academic analyst and researcher in the fields of sustainable agriculture, ecology,
agronomy, statistics, engineering and economics. Ms. Wagner has published
numerous research studies and has a deep understanding of diversified agricultural
systems including organic vegetable and dairy production, conventional corn,
soybean, and small grains production. Ms. Wagner earned her PhD. in Land
Resources and Environmental Sciences from Montana State University and attended
the University of Minnesota where she earned her Masters and BA in Biosystems and
Agricultural Engineering. She developed her expertise as head grower at Mr.
Nelson’s ATC in Montana.

III. Question: 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.

The Compassionate Science ATC will employ a powerful, integrated quality control
system that consists of the following elements:

1. Hardware and IT-based quality systems. CS-ATC will deploy a full spectrum
of quality management technologies including: automated environmental controls
for lighting, HVAC, water and air; sensors and alerts; back-up power; as well as
our proprietary IT technology that records and analyzes production from seed to
patient.

Please see Appendix entitled Data Systems.

2. Quality protocols and facility features. Compassionate Sciences staff will


operate in accordance with strict protocols for daily tasks, reporting requirements
and basic responsibilities such as sanitization checklists, labeling and data
collection requirements and pest/disease control procedures. The ATC will be
built to accommodate these best practices, with features including a clean room
where employees will change into fresh uniforms upon reporting to work and
workplace aids such as weight charts, photographs and safety reminders.

Please see Appendix H for draft operating protocols.

3. Laboratory and Analytical Facility. In keeping with our focus on delivering


pharma-standard care and advancing the science of palliative therapies, we will
build a state-of-the-science laboratory for testing, analysis and research at the CS-

27
ATC facility. For this purpose, we have engaged Dr. Noel Palmer, a consultant
who has a PhD. in the analysis of soils, plants and particularly Cannabis. Dr.
Palmer has worked directly with Cannabis researchers who established the
standard Dutch methods currently used by the government of Holland and runs
Montana Botanical Analysis, an analytical facility in Montana that is dedicated to
working with Cannabis. Dr. Palmer will work directly with our analytical
facility, set up instrumentation, and train technicians to ensure that analytical
protocols are performed with excellence.

The CS-ATC laboratory will enable real time testing and the highest levels of
quality control. In terms of production, we will be able to test and label the
various strains and measure THC levels as required by the NJMMP. In addition,
the lab will provide the organization with a technical platform to engage in
botanical research.

Please see Appendix entitled Laboratory for an overview of the CS-ATC facility
and for Dr. Palmer’s credentials.

IV. Question: The applicant shall describe:

 Methods to ensure that seed production and/or hybridization is prevented during


cultivation of medicinal marijuana;

After initial sexing of plants, CS-ATC will be working only with female plants.
Please refer to page 13, plant sexing, of the Cultivation Manual in the Appendix.

 Methods of testing for the presence of mold, bacteria or other contaminants;

Our Master Grower and cultivation staff will employ recognized methods of
identifying and testing for the presence of contaminants. In addition, CS-ATC’s
onsite laboratory (see Appendix) will enable a full spectrum of product testing for
disease conditions, potency and other crucial parameters.

Please refer to page 43, Pests and Diseases, of the Cultivation Manual in the
Appendix.

 Procedures for routine scouting of insect and plant disease conditions;

CS-ATC practices for routine insect and disease inspections are presented in the
Cultivation and Operating manuals in the Appendix.

 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;

28
The CS-ATC model does not use pesticides in cultivation and will rely on
common organic methods as described in the Operations Manual protocol in the
Appendix. ATC practices for routine insect and disease inspections are presented
in the Cultivation and Operating manuals in the Appendix.

 Procedures for proper sanitation practices to minimize plant disease, and to


promptly dispose of diseased plant material in a secured disposal area;

The CS-ATC Master Grower will establish a separate area, cannisters and
protocols dedicated to the disposal of diseased plants and plant medium. Grow
room staff will handle diseased plants and plant medium with disposable gloves
and foot coverings. The contaminated grow room will be isolated and sanitized
by spraying walls, light fixtures and floors with approved cleaning agents. CS
ATC’s multiple grow room model will allow complete and thorough sanitation of
affected areas with no risk of cross contamination.

 Methods for utilization of fans and cooling systems to maintain airflow patterns
sufficient to prevent or minimize plant disease and insect infestation;

Please refer to Site and Room Provisions in Appendix H.

 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;

After initial sexing of plants, CS-ATC will be working only with female plants.
Please refer to page 13, plant sexing, of the Cultivation Manual in the Appendix.

 Recordkeeping of any cultural measures used for plant pest or disease control,
including disposal of culled plants;

Cultural measures are recorded by barcode reader for automatic data entry into the
CS-ATC database (see Appendix entitled Data System).

 The various strains of marijuana to be dispensed, and the form(s) in which it will
be dispensed;

Three strains of Cannabis will be dispensed in low, medium and high potencies
with a maximum THC content of 10%. The product will be dispensed as the
dried and cured flower of the female plant free of seeds, stems, contaminants and
foreign matter.

In keeping with our mission to create a pharma-standard model, CS-ATC’s R&D


will focus on developing ways of delivering Cannabis like a medicine:

• In therapeutic, single-dose form to allow treatment to the dose-response curve

29
• In sterile doses with non-smoking options for immunocompromised patients
• In systems that optimize supply chain, regulatory and law enforcement
controls

 Record keeping for each package by lot, label and bar code;

CS-ATC’s proprietary software tracks all Cannabis throughout the growing and
production cycle by plant, batch and lot using a bar-coded labeling system.
Please refer to Data System in the Appendix. Patient-ready product will be
packaged in no more than ¼ ounce-counts with a label specifying:

• ATC name/address, packaging date and quantity


• Sequential serial and lot number with bar code
• Cannabinoid profile and THC level not to exceed 10%
• High, medium or low potency
• Statement of restriction to medical use by qualified patient, not for resale or
redistribution
• List of other ingredients
• Dispense date, patient name and registration ID number

 Area security;

All external and internal ATC spaces will be housed in a high-tech security
envelope in keeping with NJMMP requirements and security industry best
practices. Please see Safety and Security Plan in Appendix H.

 Packaging and labeling requirements; and

CS-ATC’s proprietary software tracks all Cannabis throughout the growing and
production cycle by plant, batch and lot using a bar-coded labeling system.
Please refer to Data System in the Appendix. Patient-ready product will be
packaged in no more than ¼ ounce-counts with a label specifying:

• ATC name/address, packaging date and quantity


• Sequential serial and lot number with bar code
• Cannabinoid profile and THC level not to exceed 10%
• High, medium or low potency
• Statement of restriction to medical use by qualified patient, not for resal
• List of other ingredients
• Dispense date, patient name and registration ID number

30
 Methods of processing in a safe and sanitary manner.

CS-ATC will process Cannabis in a secure processing room away from


cultivation and dispensary operations and adjacent to the reinforced central vault
room where all inventory will be stored (please see engineering floor plans in
Appendix H). Swipe-card access will be restricted to authorized personnel and
the room will be fully secured (please see Safety and Security Plan in Appendix
H). The space will be maintained to laboratory/pharmacy sanitary and work
environment standards. Employees will wash their hands before entering, wear
clean lab coats and latex gloves when handling product. All processing will be
done on stainless steel work benches using in-line “low touch” production
processes to minimize human contact. All work surfaces will be sanitized and the
room cleaned by processors daily and staff will observe safety and sanitation
procedures established by the NJMMP and CS-ATC management. Compliance
will be a condition of employment and will be reflected in performance reviews.

31
 
 
 
 
 
 
 

 
 
 
 
 
APPENDIX A

Certificate of Incorporation
Certificate of Good Standing
Corporation by-laws
Medical Advisory Board by-laws
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 

 
 
 
 
 
APPENDIX C

Site Analysis
Maps of Locations and Zones 
 
 
 
 
 
 
 

 
 
 
 
 
APPENDIX D

Public Safety Analysis


Maps of Drug-Free Zones 
 
 
 
 
 
 
 

 
 
 
 
 
APPENDIX E

Map of ATC Service Area by Zip Code 


 
 
 
 
 
 
 

 
 
 
 
 
APPENDIX F

Management and Trustee Biographies 


 
 
 
 
 
 
 

 
 
 
 
 
APPENDIX G

ATC Draft Operations Manual


Employee Handbook
ATC Build-out Timetable

 
1
 
 
 
 
 
 
 

 
 
 
 
 
CS-ATC Data & IT System 
 

Cultivation Manual

DRAFT
 

 
 
 
 

     


 

support 
24 
 

 
 
 
 
 

48 
 

 
 
 
 

53 
 
 
 
 
 
 
 

 
 
 
 
 
CS-ATC Laboratory & Analytical Facility

CS-ATC Chemist
 
 
 
 

 
 
 
 
 
 
 

 
 
 
 
 
Education
 
1
2
4

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