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February 14, 2011 By Hand Delivery Poonam Alaigh, MD, MSHCPM, FACP Commissioner New Jersey Medicinal Marijuana Program NJ Department of Health and Senior Services PO Box 360 Trenton, NJ 08625-0360 RE: Application to Establish and Operate Medicinal Marijuana Alternative Treatment Center in New Jersey’s Southern Region (RFA#3683_001) Dear Commissioner Alaigh: Attached please find the application of the Compassionate Care Foundation, Inc. (“Compassionate Care”) to establish and operate a medicinal marijuana alternative treatment center in the Southern Region in response to New Jersey Department of Health and Senior Services Request for Applications RFA #3683_001. Compassionate Care, a New Jersey non- profit created to cultivate and dispense pharmaceutical grade cannabis to meet medical needs, was founded by a group of former health department regulators, community leaders, healthcare professionals, researchers and non-profit directors who understand both the therapeutic value of this product and public sensitivities. Compassionate Care is committed to providing New Jersey patients with safe and affordable medicine. Compassionate Care is applying for additional permits to operate a total of three Alternative Treatment Centers – one each in the Northern, Central, and Southern Regions of the state. Our team is highly capable, qualified, and capitalized to establish and operate these three facilities. We will maintain the highest standards of quality control and accountability to prevent diversion. We have developed research protocols to enable us to collect and share required data on patient outcomes, utilization, and trends. We have undertaken outreach to local government and law enforcement in each of the communities where we propose to locate our facilities to confirm that they are receptive to our endeavor, and selected sites at an acceptable distance from sensitive uses such as schools. We have negotiated workable terms with landlords, disclosing our intent to cultivate and distribute medicinal cannabis. As a result, we are very proud to attach letters of support from throughout the state, including from local communities. Please note that this application contains security-related and proprietary information which is exempt from the Open Public Records Act (OPRA). We hereby request that you protect the confidentiality of any portions of the application for which the information is exempt from
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Awarded application submitted to the NJ Department of Health and Human Services by COMPASSIONATE CARE SOUTH as part of a public RFA. This application was awarded one of the first six medical marijuana growing and distribution sites.

February 14, 2011 By Hand Delivery Poonam Alaigh, MD, MSHCPM, FACP CommissionerNew Jersey Medicinal Marijuana ProgramNJ Department of Health and Senior ServicesPO Box 360Trenton, NJ 08625-0360 RE: Application to Establish and Operate Medicinal Marijuana Alternative Treatment Center in New Jerseys Southern Region (RFA#3683_001) Dear Commissioner Alaigh: Attached please find the application of the Compassionate Care Foundation, Inc.(Compassionate Care) to establish and operate a medicinal marijuana alternative treatment center in the Southern Region in response to New Jersey Department of Health and Senior Services Request for Applications RFA #3683_001.Compassionate Care, a New Jersey non-profit created to cultivate and dispense pharmaceutical grade cannabis to meet medical needs, was founded by a group of former health department regulators, community leaders, healthcare professionals, researchers and non-profit directors who understand both the therapeutic value of this product and public sensitivities. Compassionate Care is committed to providing New Jersey patients with safe and affordable medicine.Compassionate Care is applying for additional permits to operate a total of three Alternative Treatment Centers one each in the Northern, Central, and Southern Regions of the state.Our team is highly capable, qualified, and capitalized to establish and operate these three facilities. We will maintain the highest standards of quality control and accountability to prevent diversion.We have developed research protocols to enable us to collect and share required data on patient outcomes, utilization, and trends. We have undertaken outreach to local government and law enforcement in each of the communities where we propose to locate our facilities to confirm that they are receptive to our endeavor, and selected sites at an acceptable distance from sensitive uses such as schools.We have negotiated workable terms with landlords, disclosing our intent to cultivate and distribute medicinal cannabis. As a result, we are very proud to attach letters of support from throughout the state, including from local communities.Please note that this application contains security-related and proprietary information which is exempt from the Open Public Records Act (OPRA). We hereby request that you protect the confidentiality of any portions of the application for which the information is exempt from OPRA. Relatedly, please retain this cover letter with the application at all times so that this request is honored without fail. As President and Chief Executive Officer of Compassionate Care, I can and do attest to the accuracy and veracity of all statements, figures, amounts and other information incorporated within the materials submitted.Thank you very much for your efforts to enable patients to obtain medicinal marijuana, and for your careful consideration of our application to assist in those efforts.Sincerely, Compassionate Care Foundation, Inc. William J. Thomas President & CEO TABLE OF CONTENTS TABLEOFCONTENTS INTRODUCTION.............................................................................................................................................1 CRITERION 1 - INFORMATION REGARDING APPLICANT & FACILITY......................................................3 CRITERION 2 - OPERATIONAL INFORMATION..........................................................................................11 CRITERION 3 - COMMUNITY INPUT AND APPROVAL ...............................................................................20 CRITERION 4 - PATIENT CARE CENTER SPECIFIC CONSIDERATIONS......................................................22 CRITERION 5 - CULTIVATION SPECIFIC CONSIDERATIONS .....................................................................35 APPENDIX A CORPORATE DOCUMENTS ...............................................................................................A1 APPENDIX B EVIDENCE OF SITE CONTROL........................................................................................A19 APPENDIX C EVIDENCE OF ZONING COMPLIANCE........................................................................... A21 APPENDIX D DISTANCE TO SENSITIVE SITES .....................................................................................A24 APPENDIX E ZIP CODE MAP OF SERVICE AREAS ..............................................................................A26 APPENDIX F QUALIFICATIONS AND POSITION DESCRIPTIONS .........................................................A28 APPENDIX G OPERATIONS PLAN......................................................................................................... A51 APPENDIX H SECURITY PLAN..............................................................................................................A93 APPENDIX I EMPLOYEE TRAINING MANUAL ...................................................................................A114 APPENDIX J HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) MANUAL............ A116 APPENDIX K HUMAN RESOURCES MANUAL ....................................................................................A121 APPENDIX L CULTIVATION OVERVIEW............................................................................................A135 APPENDIX M HYDROPONIC DESIGN ................................................................................................. A137 APPENDIX N PRODUCT SAFETY PLAN...............................................................................................A139 APPENDIX O FIRE SAFETY PLAN....................................................................................................... A142 APPENDIX P ENVIRONMENTAL PLAN................................................................................................A144 APPENDIX Q FINANCIAL PRO-FORMA..............................................................................................A146 APPENDIX R LETTERS OF RECOMMENDATION................................................................................A174 INTRODUCTION 1 TheCompassionateCareFoundationInc.(CompassionateCare)verymuchappreciatesthe opportunitytosubmitthisapplicationforapermitfromtheStateofNewJerseyinresponseto DHSS RFA #3683_001 (RFA). We seek a permit to cultivate and dispense medicinal cannabis inBellmawr,NewJersey.Wearesimultaneouslysubmittingadditionalpermitapplicationsto operate Alternative Treatment Centers (ATC) in the states Central and Northern Regions. Compassionate Care is a non-profit corporation organized under the State of New Jersey with the mission of providing therapeutic pain relief to patients in need and conducting research into the effectivenessofmedicinalcannabisfortheindividualsandcommunitiesweserve.Foundedin 2011,CompassionateCareisleadbyaBoardofDirectorswhosemembersaremedical professionals,formerhealthdepartmentregulators,communityleaders,andresearchers.They are committed to providing New Jersey patients with safe and affordable medicinal cannabis. Usingadvancedhorticulturaltechnology,weoffermanyvarietiesofpharmaceuticalgrade cannabis. Our unique approach allows us to trace the genetic strand of every plant, to protect our medicinalproductsfromdisease,pest,andmold,andtoensurethatourmedicinalcannabisis maximallyeffectiveforourpatients.Werealizethatourcorporatesustainabilitydependsona reciprocalrelationshipwithourhostcommunityandsurroundingenvironment.Wemake substantialcontributionstoourhostcommunitiesthroughjobcreationandcharitablegiving. Moreover, we operate environmentally responsible facilities, use cultivation methods with zero wastepolicesandprocedures,relyuponhighsecurityprotocolstoensurethesafetyofour workersandourneighbors,andconductasophisticatedresearchanddevelopmentprogramon medicalcannabisefficacy.Ourcommitmenttotheenvironment,workers,customers,andour community are reflected throughout this document. TheorganizationofthisapplicationmirrorsthestructureoftheRFAasectionforeach criterion,andwithinthat,asubsectionforeachmeasure.Thus,Section1providesinformation requested about the applicant (Compassionate Care) and the cultivation facility and patient care center for which we are seeking this permit. Section 2 describes requested information about our operating plans, policies, and funding.Section 3 describes our proposed methods for obtaining theinputandsupportofourhostcommunities(frommembersofthepublicaswellaslocal governmententities).Section4detailsmorespecificallythepatientcare,datacollection, security,andeducationalprogramsandprocedureswewilluseinoperatingthesefacilitiesand the interface between this cultivation center and our patient care center. Section 5 focuses on our cultivation procedures. Section 6 contains eleven appendices (e.g., zoning compliance documents and letters of support from local communities).INTRODUCTION 2 ThisproposalwillspecificallyarticulateourknowledgeofandconformancewiththeStateof New Jerseys medical cannabis program and addresses, item by item, the requirements under the RequestforApplications.Insummary,thisapplicationdemonstratesthereasonswhy Compassionate Care is unsurpassed in the experience, capabilities, and qualifications needed to operate an ATC. Based upon these attributes and the information contained in the remainder of thedocumentitisourhopethatthereviewerswillconsiderourorganizationforapermitto operate an ATC for medical cannabis in the south section of State of New Jersey. CRITERION 1 3 CRITERION1INFORMATIONREGARDINGAPPLICANT&FACILITY Measure 1: The applicant shall provide the proposed legal name and the following documentsapplicable to the applicants legal status. Supporting documents should be included asAppendixA.CertificateandArticlesofIncorporationandByLawsforcorporationsOrganizingdocumentsforassociationsEvidenceofnonprofitstatusCertificateofgoodstandingissuedbytheNewJerseySecretaryofStateTheproposedlegalnameofourentityisCompassionateCareFoundation,Inc.Wehave attached the following supporting documents: Certificate of Incorporation of Compassionate Care Foundation, dated February 4, 2011 By-Laws for Compassionate Care Foundation, dated February 9, 2011 CertificateofGoodStandingforCompassionateCareFoundation,issuedbythe New Jersey Secretary of State on February 7, 2011 Business Registration Certificate1 Appendix A: Corporate Documents Measure2:Theapplicantshallprovidetheproposedphysicaladdress(es)oftheATC,ifapreciseaddresshasbeendetermined.SupportingdocumentsshouldbeincludedasAppendixB.For each proposed physical address, the applicant shall provide legally bindingevidence of site control (e.g., deed, lease, option, etc.) sufficient to enable theapplicant to have use and possession of the subject property including, but notlimitedto,lengthoftermofuseandpossession.Iftheapplicantintendstocultivatemedicinalmarijuanaatonephysicaladdressanddispense it at another, both facilities shall be located within the same region asdefined in Subchapter 1 of N.J.A.C. 8:64, the Rules Related to the MedicinalMarijuanaProgram.Ifapreciseaddresshasnotbeendetermined,theapplicantshallidentifythegenerallocation(s)wherethefacilitieswouldbesited,andwhen.CompassionateCareplanstooperateitscultivationandpatientcarecenteratseparate locations within the same region, as follows: 1 Evidence of Compassionate Cares nonprofit status is included in its Bylaws and Certificate of Incorporation. Compassionate Care is in the process of filing for its business registration certification.This process will be complete by April 4, 2011. CRITERION 1 4 Measure2Responsecontda)CultivationFacility.Thecultivationfacilitywillbelocatedat330Benigno Boulevard,Bellmawr,NJ08031.WehaveattachedaLetterofIntent,dated February2,2011,fromBradfordPricetotheDepartmentsOfficeofLegaland RegulatoryCompliance,showingapreliminaryagreementfora10-yearleasefor Compassionate Care to use and possess the site as a cultivation facility. b)Patient Care Center.While we have not selected the precise address of our patient carecenter,itwillbelocatedinthesamemunicipalityandinthesameregionas ourcultivationfacility,asdefinedinN.J.A.C.8:64-1.2.Ifawardedapermit,we willidentifyandsecurethefinalsite forthepatientcarecenterwithinthirty(30) days from permit approval. Appendix B: Evidence of Site Control Measure 3: The applicant shall provide evidence of compliance with the local zoning laws foreachaddressorproposedlocationforanATC.Ifthecurrentzoningisnotappropriateforagiven address or location, identify any required zoning variance(s) and the applicantsactions taken to date to obtain such approval(s) and/or variance(s). Supporting documentsshouldbeincludedasAppendixC.CompassionateCare'scultivationfacilitywillbelocatedintheHeavyIndustrialZone DistrictoftheBoroughofBellmawr.Whilethecodedoesnotspecificallyaddressour proposeduseofharvestingandpackagingmedicalcannabis,wewillmaketheappropriate site plan /variance applications if required by the Township in order to secure a certificate of occupancy.In addition, we will locate our patient care center in an area consistent with the zoning requirements for the area. We currently do not anticipate any major zoning variance request or approvals needed for the patient care center. Appendix C: Evidence of Zoning Compliance Measure4:TheapplicantshallprovideevidencethatallofthephysicaladdressesandproposedlocationsprovidedinresponsetoMeasure2arenotlocatedwithinadrugfreeschoolzone.The applicant shall provide the distance to the closest school from the ATC. SupportingdocumentsshouldbeincludedasAppendixD.CommunitysafetyisatoppriorityforCompassionateCare.Ourcultivationfacilityisnot locatedwithinadrug-freeschoolzone.Theclosestdistancetoaschoolis0.9miles.We alsowillselectapatientcarecenterlocationthatisnotlocatedwithinadrug-freeschool zone.Wehaveprovidedatableshowingdistancetotheclosestschoolandotherselect locations as defined in the regulations. Appendix D: Distance to Sensitive Sites CRITERION 1 5 Measure 5: The applicant shall provide a legible map or maps of the ATC service areas by ZipCodetobeservedbytheATC.SupportingdocumentsshouldbeincludedasAppendixE.We have attached a legible map with zip codes of the areas that will be served by our patient carecenter.Inordertoprovideaccessforthelargestnumberofthoseinneed, Compassionate Care will welcome and be prepared to serve all registered patients residing in anyofthecountiesintheregionasdefinedintheNewJerseyCompassionateUseMedical Marijuana Act (the Act). Appendix E: Zip Code Map of Service Areas Measure6:Theapplicantshallprovidetherole,qualifications,name,addressanddateofbirthofeachstaffmemberandtherole,name,percentageinterest,addressanddateofbirthofeachprincipal,officer,boardmemberorpartneroftheATC.Intheeventthatanindividualhas not yet been identified, a statement of required qualifications and position descriptionshallbeincludedasAppendixF.TheCompassionateCareteamiscomposedofformerhealthdepartmentregulators, community leaders, healthcare professionals, researchers, and nonprofit directors committed to providing qualifying patients, their caregivers, and their healthcare providers with current, scientificallyaccuratecareandinformationaboutmedicalcannabis.LedbythePresident and Chief Executive Officer, William Thomas, the Board includes: WILLIAM J. THOMAS Mr. Thomas has spent the last 41 years developing methods for deliveringhealthcareataffordablepriceswhilemaintainingthe highestlevelsofquality.Hehasdemonstratedonmany occasionsthathecanbuildandmaintainalargeorganization. Since selling his consumer-focused health insurance company in 2007, he has been working with the application of social media to improve the quality and cost of healthcare. In 2009, he started workingastheleadresearcherfortheLeapfrogDueDiligence Cooperative. Membership includes the New Jersey Health Care QualityInstituteandmanyNewJerseycompaniesandunions. Thefocusofhisresearchhasbeenthecomparativeeffectivenessofdiseasemanagement vendors,prescriptionbenefitmanagers,andwellnesscompanies.Mr.Thomaswasaskedto serve on the board because of his experience with the delivery of health care services and his ability to grow organizations from the ground up. CRITERION 1 6 Measure6ResponsecontdDAVID KNOWLTON Mr. Knowlton is the CEO of the New Jersey Healthcare Quality Institute,anonprofithealthcarethinktank. TheBoardofthe Instituteincludesallofthemajorhealthcarestakeholdersin NewJersey.Mr.KnowltonistheformerDeputyHealth CommissionerofNewJerseyandiscurrentlytheNational ChairmanoftheLeapfrogGroup,anonprofithealthcare researchorganization.Leapfrogisanemployermember-driven nonprofit representing over 2,200 employers, including the New JerseyHealthCarePayersCoalition.Mr.Knowltonwasasked toserveontheBoardbecauseofhisknowledgeofthehealthcareneedsofNewJerseyand his experience with managing nonprofit organizations. JAMES C. HERRMANN Mr.HerrmannisthePresidentofJamesC.Herrmann& Associates,Ltd.,(JCH),afullserviceinsuranceagencyand brokeragelocatedinRockvilleCentre,NewYork.Mr. Herrmannbeganhisinsurancecareerin1986,specializingin healthcareprofessionalliabilityandfinancialservices.Today, thesetwoareasrepresentasignificantportionofJCHs business.JCHinsuresnumeroushealthcarefacilities, physicians, and nonprofit agencies.JCH also maintains a large presenceintheconstructionandrealestateindustries, representing contractors, developers, and real estate companies. Mr.HerrmannwasaCaptaininTheRockvilleCentreVolunteerFireDepartment,thepast PresidentoftheFriendsofMercyMedicalCenter,andaformerboardmemberofMercy MedicalCenterandOurLadyofConsolationNursingHome.Heiscurrentlyamemberof the Board of Trustees of the Long Island Power Authority, the State University of New York CollegeatOldWestburyFoundation,theUnitedCerebralPalsyAssociationofNassau County, and the Long Island 9/11 Memorial. Mr. Herrmann was asked to serve on the Board becauseofhisextensiveexperiencewithriskmanagementandhisknowledgeofnonprofit operations. In addition, the following people have agreed to join our Board: CRITERION 1 7 Measure6ResponsecontdANN MARIE HILL Mrs.HillistheExecutiveDirectoroftheNewJerseyState Commission on Cancer Research and the Internship Coordinator for the Edward J Bloustein School of Planning & Public Policy, Rutgers University, New Brunswick, NJ.At Rutgers, Mrs. Hill currentlycoordinatesover200studentsayearinseniorpublic healthinternships,andalsoteachesresearchdiffusionand seniorworkplacetransitionissues.Inaddition,sheconducts researchactivitiesonhealthcaredisparities,cancer survivorship,clinicaltrialrecruitment,communityhealthand outreach,andresearchdissemination.Mrs.Hillwasaskedto serveontheBoardbecauseofherexpertiseinpublichealth,cancer,andthediffusionof research. JEFFERY WARREN Mr.Warrenhasmorethan30yearsofhealthcareleadership experience,includinggovernment,hospitaladministration, philanthropy,consulting,andworkinthepharmaceutical industry. Mr.WarrenisaprincipalwithJRMarketStrategies, LLC, a healthcare consulting firm.Most recently, he served as asenioradvisor/consultanttotheNationalPharmaceutical Council (NPC).Prior to NPC, Mr. Warren was responsible for strategicmarketingandmediarelationsforPfizerHealth Solutions. Earlierinhiscareer,hewasExecutiveVice PresidentofCorporateDevelopmentforCathedralHealthcare System.During his tenure with Cathedral, Mr. Warren was a National Program Director for the Robert Wood Johnson Foundations New Jersey Health Services Development Program.Mr.WarrenspastexperienceincludestenureasVicePresidentofCorporateDevelopment with the Hackensack Medical Center.He also was named the first Executive Secretary to the New Jersey Hospital Rate Setting Commission. Mr. Warren was asked to serve on the Board becauseofhisknowledgeofthepharmaceuticalindustryandNewJerseyhealthcareissues, and because of his service on nonprofit boards. CRITERION 1 8 Measure6ResponsecontdJOANN LANGE Ms.Langehasanextensivebackgroundinconsumer communications and marketing. She has worked on projects for severalpharmaceuticalcompaniesandaneducationcompany servinghealthcareproviders.Ononeprojectshedrovethe creationandtheverificationofaconsumerdatabaseforuseby suchclientsasPfizerandAstra-Zeneca.Thedatabasetracked medicalconditionsformorethantwomillionconsumers.. Ms. LangeisalsoontheBoardoftheRoboticEducation Foundation.Ms.LangereceivedanMBAfromHarvard University. Ms. Lange was asked to serve on the Board because of her expertise in educating health care consumers and providers. MARK DUMOFF Mr. Dumoff is the President of Healing Spaces, Inc., a 501(c)3 nonprofitcorporationhefoundedin2005.Themissionof Healing Spaces is to Bring Healing to the Home by creating DreamBedroomsthatenhancethespiritandqualityoflife forchildrenfromunderprivilegedfamiliesinNewJerseywho are fighting cancer and other serious illnesses.Healing Spaces partnerswithleadingpediatriconcologyhospitalsinNew JerseysuchasTomorrowChildrensInstituteatHackensack UniversityMedicalCenter,Children'sHospitalofNewJersey atNewarkBethIsraelMedicalCenter,andtheBristol-MyersSquibbChildren'sHospitalat RobertWoodJohnsonUniversityHospital.Mr.DumoffalsoisCEOandPresidentof RelationalInsights,Inc.(akaDocInsight),ahealthinformationtechnologystrategy, development,andservicescompany.DocInsightisfocusedonpatientexperience measurementandenhancedcarecoordinationwithinaPatientCenteredMedicalHomeand AccountableCareOrganizationsetting. Mr.DumoffwasaskedtoserveontheBoard becauseofhisexperiencewithmanaginganonprofitandforhisexpertiseinassessingand surveying patient experience. OurPresidentandChiefExecutiveOfficer,Mr.WilliamThomasisinplace.Wehave attachedotherkeystaffpositiondescriptionsandinformationrequestedregardingtherole, qualifications,name,address,anddateofbirthofeachstaffmember,aswellastherole name,percentageofinterest,address,anddateofbirthofeachprincipal,officer,board member, or partner of Compassionate Care. Appendix F: Qualifications and Position Descriptions CRITERION 1 9 Measure 7: Disqualifying Drug Offenses: In considering any application for an ATC permit, anapplicant must disclose and the Department shall consider, at a minimum, the followingfactorsinreviewingthequalificationsofthosepersonsapplying:Whether the applicant or any staff member, principal, officer, board member orpartner has been convicted under any Federal, state or local laws, relating to drugsamples,wholesaleorretaildistribution,ordistributionofacontrolledsubstanceWhether the applicant or any staff member, principal, officer, board member orpartnerhasbeenconvictedofafelonyunderanyFederal,stateorlocallawsThe past experience in the manufacturing or distribution of drugs or controlledsubstancesbytheapplicantoranystaffmember,principal,officer,boardmemberorpartnerWhether the applicant or any staff member, principal, officer, board member orpartnerhaseverfurnishedfalseorfraudulentmaterialinanyapplicationconcerningdrugmanufacturingordistributionWhether the applicant is in compliance with any previously granted professionalhealthlicenseorregistration,ifanyAnyotherfactorstheDepartmentmightconsiderrelevant CompassionateCareiscommittedtothehighestethicalstandards,patientsafety,and transparencyinitsoperationsandbusinesspractices.Baseduponpreliminarybackground checks, our staff members, principals, officers, board members, and partners do not have any potentiallydisqualifyingdrugorothercriminaloffenses.Inaddition,totheextent applicable,allare,andwillcontinuetobe,incompliancewithpreviouslygranted professionalhealthlicensesandregistrations.Finally,eachprincipal,director,board member,owner,andemployeewillberequiredtoprovidewrittenconsenttosubmittoa criminalhistoryrecordbackgroundcheckpursuanttoN.J.S.A.24:61-4.Toensure transparency,theentirebackgroundcheckprocesswillbeconductedbyanoutside, independentthird-partyagency.WewillimmediatelynotifytheDepartmentofHealth(the Department)ifanyprincipal,officer,boardmember,oremployeehasanydisqualifying drug offenses or other reportable events as defined by the Department. Measure8:Theapplicantshallprovidetheidentitiesofallitscreditors,ifany.CompassionateCaredoesnotcurrentlyhaveanycreditors.Allstart-upcostshavebeen incurred by one or more of Compassionate Cares Board members.See financial statements that set forth categories of future creditors. Appendix Q: Financial Pro-Forma CRITERION 1 10 Measure9:TheapplicantshallprovidealistofallpersonsorbusinessentitieshavingdirectorindirectauthorityoverthemanagementorpoliciesoftheATC.CompassionateCareismanagedbyitsofficers/keystaffandBoardofDirectors. Noother person or business entity has a direct or indirect authority over the management or policies of CompassionateCare. ThenameofthePresidentandChiefExecutiveOfficerisWilliam Thomas. ThecurrentnamesoftheBoardmembersresponsibleforthemanagementof Compassionate Care are:

William J. Thomas David Knowlton James C. Herrmann See Board bios in Criterion 1, Measure 6 above.Measure 10: The applicant shall provide a list of all persons or business entities having anindirect interest in the ATC. An indirect interest includes an interest in the land or buildingwheretheATCwillbesited.The landlord for Compassionate Care will be Albert E. Price, Inc., which does not have any interestorownershipinCompassionateCare.Ifgrantedapermit,CompassionateCare anticipates having several categories of third-party vendors to provide management, security, scientific,andotherprofessionalfunctions.Wehaveprovisionallyidentifiedvendorsfor specific services, including the following: Security: Henry Brothers Electronics and Universal Safety Response Product Safety Testing: CW Analytical Hydroponic Supplies/Cultivation Oversight: weGrow Enterprises, Inc. Accounting Firm: Lynn Elliott Transportation Security Services: Dunbar Armored See financial statements that set forth categories of future creditors. Appendix Q: Financial Pro-Forma Measure 11: The applicant shall include the required application cover sheet and attestationstatementsignedbyitschiefexecutiveofficerorotherindividualauthorizedtomakelegallybindingcommitmentsonitsbehalf.See cover letter and attestation statement at beginning of application. CRITERION 2 11 CRITERION2OPERATIONALINFORMATION Measure 1: The applicant shall provide a draft operations manual and training plan whichdemonstrates compliance with Subchapter 9 of N.J.A.C. 8:64, the Rules Related to theMedicinal Marijuana Program and which addresses ATC General AdministrationRequirements for Organization and Recordkeeping. Supporting documents should beincludedasAppendixG.TocompliancewithSubchapter9ofN.J.A.C8:64,wehaveaddressedallofthespecific requirementsinourOperationsPlan.Becauseoftheconfidentialandproprietarynatureof ourOperationsPlanandTrainingManual,wehaveprovidedalladditionaldocumentation that would ordinarily be included in our Operations Plan as separate appendices for sampling purposes. Full copies are available for review in hardcopy, at the Departments request. The components of our Operations Plan include the following:

Appendix G: Operations Plan and Training Manual (For compliance with Subchapter 9) Appendix H: Security Plan (Available for full view) Appendix I: Employee Training Manual Appendix J:The Health Insurance Portability and Accountability Act (HIPAA) Manual Appendix K: Human Resources Manual Appendix L: Cultivation Overview Appendix M: Hydroponic Design Appendix N: Product Safety Plan Appendix O: Fire Safety Plan Appendix P: Environmental Plan Measure 2: The applicant shall provide a description of how the ATC will operate on a longterm basis as a notforprofit entity and a business plan that includes, at a minimum, thefollowing:To operate on a long-term basis as a nonprofit entity, Compassionate Care intends to operate aleanorganizationtoprovidepatientswithaffordablemedicine.Thepriceofourmedicine will be equal to our cost. As our organization becomes more efficient over time and expands itspatientbase,weintendtoreduceourpricesandinvestmoreintoareasthatpromotethe long-term wellbeing of our patients and the surrounding communities. CRITERION 2 12 Measure2ResponsecontdOur primary focus areas will be: 1.Reducing the cost of our medicine and expanding our indigent care program 2.Investing in our research and development program 3.Developing and expanding our charitable and philanthropic programs 4.Providing additional worker education and training 5.Offering more free healthcare services to patients 6.Increasing product safety, hygiene and quality assurance standards Measure2I:TheapplicantshallprovideadetaileddescriptionabouttheamountandsourceoftheequityanddebtcommitmentfortheproposedATC.a)Theimmediateandlongtermfinancialfeasibilityoftheproposedfinancingplan;b)Therelativeavailabilityoffundsforcapitalandoperatingneeds;andc)Theapplicantsfinancialcapability.CompassionateCarehasreceivedacommitmentofforty-fivemilliondollars($45,000,000) fromMetropolitanFinancialHoldingstooperateuptothreeATCs.Wehaveprovideda financialcommitmentletterandevidencethatthefundsareavailablethroughfinancial statements.SeeLetter,datedFebruary7,2011,fromGoldieDickeyandBenPenfieldof MetropolitanFinancialHoldingstoJamesHerrmannandtheCompassionateCare Foundation. The funds for this project have been set aside for our project, pending approval of our permits. Appendix Q: Financial Pro-Forma a)THEIMMEDIATEANDLONGTERMFINANCIALFEASIBILITYOFTHEPROPOSEDFINANCINGPLANWehavecompiledcomprehensivefinancialstatementsthatshowtheimmediateandlong-term financial feasibility of our proposed financing plan. Because of the confidential and proprietary nature of our full business plan, complete copies are available for review in hardcopy, at the Departments request. Appendix Q: Financial Pro-Forma b)THERELATIVEAVAILABILITYOFFUNDSFORCAPITALANDOPERATINGNEEDSMetropolitanFinancialSolutionshasblockedandheldinsupportfundsforourcapitaland operatingneedsasevidencedinthefinancialcommitmentletterprovided.SeeCriterion2, Measure 2-I. Appendix Q: Financial Pro-Forma CRITERION 2 13 Measure2IResponsecontdc)THEAPPLICANTSFINANCIALCAPABILITYAs indicated in our attached financial statements, Compassionate Care is financially capable ofcarryingoutourplansdescribedwithinthisproposal.Ourleadershiphasownedand operatedmanysuccessfulventuresovertimeandhasthecapacitytobuildandoperatea cultivation facility and patient care center if awarded a permit. Measure 2II: The applicant shall provide a copy of its proposed policy regarding charitycare/servicingindigentpatients.CompassionateCarehastwobasiccharitablemissions.Thefirstistoprovidehighquality medicine to patients in need. The second is to expand the understanding of the clinical effects ofmedicinalcannabisandhowitshouldbeusedinthetreatmentofdifferentdiseasesand conditions.ThissectionbrieflysummarizesCompassionateCaresbasicapproachtoour charitablemissions,butitshouldbeunderstoodthatourboardandmanagementwillbe refiningourcharitableprogramsonanongoingbasisinresponsetoourexperienceand evolving patient and community needs. Asmentionedabove,ourfirstcharitablemissionistoprovidethebestqualitymedical cannabis to patients who can benefit from this treatment.In our cultivation facility we will usestate-of-the-arthorticulturalequipmentandmethodsaswellasscrupuloushygienic practicestoensureourproductissafeandhealthful.Inourpatientcarecenterweare dedicatedtoprovidinginformedandcaringpatienteducationwithexceptionalcustomer service.Weaimtoberecognizedastheindustryleaderinourfieldandwillleverage systematicpatientfeedbackandongoingdialoguewiththemedicalcommunityto continuously improve our products and services. Animportantaspectofourpatientcaremissionisourcommitmenttoincreaseaccessto medical cannabis for those who are medically underserved.Most immediately we recognize thatpeoplewithchronicorterminalillnessoftenhavelimitedfinancialmeans,frequently madeworsebythelossofabilitytoworkandtheexpenditureofincomeonexpensive medicalandcustodialcare.Wewillneedtorefinethedetails,butweintendtomake generousprovisionsforpatientswhoneedbutcannotaffordourproductorthespecialty equipmenttoconsumeit.Accessissuesformedicalcannabisareespeciallypronounced because cannabis is currently a self-pay drug product. Neither public nor commercial insurers provideanysubsidiesorreimbursementtopatientselectingtousethismedicine.Withour boardsexperienceinthehealthcareandinsuranceindustries,weexpecttobringforth researchthatwillpersuadethird-partypayerstoreimbursepatientsusingmedicalcannabis forconditionsforwhichithasbeenshowntobeclinicallyefficacious,safe,andcost-effective in comparison to alternative therapies. CRITERION 2 14 Measure2IIResponsecontdThisleadsustoCompassionateCaresresearchmission.Atthepresenttimethereisclear and convincing evidence that cannabis is a safe and effective product for many patients, but we do not yet have the level of knowledge that would allow physicians to confidently guide patients on the maximum benefits associated with use of the product.Experts in the field of painmanagementagreethatcannabisisoneoftheleastaddictiveofcurrentlyavailable therapies and has fewer serious risks and toxicities than other drugs, but further research and education on these issues is needed to rectify long-standing misperceptions about the relative safetyofcannabis.TheNationalInstitutesofHealthhasrecentlyannouncedanewgrant programforresearchontheclinicaleffectivenessofcannabis,andCompassionateCareis applying for one of these grants, conditioned on our success in obtaining a permit for one or morepatientcarecenters.Whetherweobtainagrantornot,wewilluseaportionofthe fundsfromsalestoconductourownresearchonthesematters.Wewillbeeagertowork with the Department and other state agencies to document New Jersey patients experiences with medical cannabis so this knowledge can be used to inform future regulatory policies and practices. YoucanseefromreviewingtheprofilesofmembersofourBoardandourindependent MedicalAdvisoryBoard(seebelow)thatweareveryseriousaboutresearch.Thekeyto gatheringthedataweneedoneffectivenessistoobtainpatientparticipation.Weneed patientstoreporttheirexperiencewiththedrug.Weneedtoknowhowtheuseofspecific strainsandstrengthsofthedrugaffectssymptomssuchaspainandnausea.Sinceour organization is new and therefore unknown to the patient population of New Jersey, we will needthesupportofthelongstandingpatientadvocacyorganizationsandcharities.Tothis endwehavereachedouttocharitiessuchasGildasClubandothersimilarorganizations. Weintendtoprovidefundingtotheseorganizationstoadvancetheunderstandingof medicinalcannabis.Inreturnwehaveaskedthattheyencouragetheirmedicalcannabis-using clients to participate in our outcomes studies.Some of their clients who use medicinal cannabis will already be known to us because they are also our clients. Therefore, there is no breachofconfidentiality.Weanticipatethecharitieswillgiveusgeneralsupport,not specificclientinteraction.Wearenotsuggestingthattheyrecommendusingmedical cannabis.Weonlyneedtheirassistanceinencouragingtheirclientstoparticipateinthe research. Thesepatientsupportorganizationswillbenaturalplacesforustodistributeeducational information about medicinal cannabis.There are special organizations such as the Childrens CancerNetworkwheredistributinginformationabouttheuseofthisdruginpatientsunder theageof18willbecritical.ThereareotherorganizationssuchastheNewJerseyHealth Care Quality Institute, the New Jersey Nurses Association, the New Jersey Medical Society, theNewJerseyHospitalAssociation,andtheNewJerseyHealthcarePayersAssociation where there are opportunities for education and support. We will offer our experts and Board members the opportunity to meet with these organizations and their members to discuss the useandeffectivenessofthisdrug.OurBoardmembershaveworkedwithallofthese organizations in the past either as members, supporters, or board members. CRITERION 2 15 Measure2IIResponsecontdWe will also reach out with education to employers because they may have employees who areusingthedrugandtheemployersshouldbeawareofitseffectsonemployee performance.Employersmayalsoelecttofundtheprescriptionsintheirbenefitplanifwe canshowthroughcomparativeeffectivenessresearchthatmedicalcannabisismorecost effective. Tofacilitateourinteractionwithcharitiesandotherimportantorganizationswehaveasked currentboardmembersofcharitiestoparticipateinaCharitableResearchSupport Committee.ThiscommitteewillbeheadedbyMr.KennethMerin,theformerNewJersey Insurance Commissioner and current President of the Charles Hayden Foundation.Measure 2III: The applicant shall provide a copy of its proposed policy related to disposal ofreturnedorunusablemarijuana.CompassionateCarehasdevelopedareturnpolicybasedonourprinciplesandour understanding of the Medical Marijuana Program (the MPP).We anticipate that aspects of the return policy may be revised as the Department further clarifies the rules of the Program.Compassionate Cares policy on unused or returned medication is guided by three orienting objectives: Ensure product safety issues are promptly identified, analyzed, and corrected; Provide excellent value and service to our patients; and Minimize opportunities for diversion Before abatchof medicinal cannabisispackaged,a sample will be tested inour laboratory for pests, molds, and other contaminants, and we will also analyze the cannabinoid profile of product (details are provided in Criterion 5, Measure 3).Any medicinal cannabis found to be deficient,whetherbecauseofmold,excessiveTHC,orotherissues,willbeincinerated.In addition, excess inventory will periodically be destroyed to prevent any unauthorized use or distribution.Anon-siteincineratorinasecureroomofthefacilitywillbeusedforthis purpose. CRITERION 2 16 Measure2IIIResponsecontdIf a patient or caregiver returns product claiming that it is defective, our staff will complete a reportonthecomplaintandtakepossessionofthereturnedproduct.Thereturnedproduct will be weighed, and if the returned product is >50% of the volume purchased, the customer willbeeligibleforafullrefundofthepurchaseprice.Also,thecustomermayapplythe valueoftheproductreturnedtoanothermedicationpurchase.Aseachpatientmayonly purchasetwoouncesofmedicationpermonth,patientsreturning>50%ofaquantityof medicineforqualityreasonswillbeabletoreplacethatallotmentwithintheirtwo-ounce-per-month purchase limit.Patients making returns of less than half of the product purchased will be eligible for a refund of the purchase price, but they will only be able to buy substitute product if they have not reached their purchase limit for the month, inclusive of the product returned.With this policy we hope to balance consumer protections with the Acts objective to limit personal consumption of medicinal cannabis to no more than two ounces of medicine per month. Anyproductreturnedforqualityreasonswillbesenttoourlaboratoryforinspectionand analysis.If the product has evidence of pests, contaminants, or other problems, we will use our inventory tracking system to identify all products produced from the same plant, whether theyareinourcultivationfacilityorpatientcarecenter,orhavebeensoldtopatientsand caregivers.Uponreceiptofreturnedproductfromthepatientcarecentertheproduct receivedwillbeweighedanditsweightcomparedtorecordedweightoftheproductwhen returned.Management and security will investigate discrepancies and any reportable events willbecommunicatedtotheDepartment.Oncethesourceplantassociatedwithaproduct qualityproblemhasbeenidentified,anyrelatedproductthatremainsinourpossessionwill be returned to the lab for inspection and the product will be destroyed.We will also issue a consumer alert to patients who have received related product, and they will be encouraged to returnthepotentiallydamagedproducttotheirpatientcarecenter.Anyreturnedproduct receivedbyourpatientcarecenterwillbesenttoourcultivationfacilitywhereitwillbe incineratedafterappropriatesampleshavebeenprovidedtothelaboratoryforanalysis.Throughoutthisprocessthevolumeoftheproductwillberecordedinourinventory managementsystem,sotherewillbethoroughdocumentationoftheproductsdisposition and any diversion can be identified and managed as required by New Jersey law and the rules of the Department. Measure 2IV: The applicant shall complete the following projected income statements for thefirstthree(3)yearsofoperation.Roundallamountstothenearestdollar. CRITERION 2 17 COMPASSIONATE CARE FOUNDATION, INC.PROJECTED INCOME STATEMENTSREQUIRED FORMAT!"#$%&$%'("!%%%%)*++,-!./%,&00%,-.1"0%'("!%%%%%%%%)*+).(1234%,&00%,-.1"0%'("!%%%%%%%%%)*+58LvLnuLMedlclnal marl[uana sales Lo realsLered quallfvlna pauenLs 13,123,000 $ 37,062,300 $ 73,362,300 $CLher supplles sold Lo realsLered quallfvlna pauenLs 243,030 $ 1,139,273 $ 1,337,200 $ CLher revenue sources:(ldenufv) Medlclne ulscounLs (3,706,230) $ (7,336,230) $ 1C1AL 8LvLnuL 13,370,030 $ 32,313,323 $ 67,363,430 $LxLnSLS:Medlclnal marl[uana arowlna 3,293,027 $ 13,337,373 $ 18,606,787 $Medlclnal marl[uana Lesuna 103,440 $ 326,828 $699,817 $Medlclnal marl[uana packaalna and labellna 28,300 $ 43,000 $37,000 $Medlcal 8esearch 1,337,003 $ 6,392,178 $ 10,434,470 $1echnoloav 113,960 $ 317,931 $730,370 $Call CenLer 72,914 $ 179,776 $197,687 $SecurlLv 784,767 $ 2,163,104 $ 2,309,042 $ Supplles 9,000 $ 16,300 $27,000 $Cmce Lxpense 70,130 $ 203,400 $390,630 $uullues 781,438 $ 2,803,469 $ 3,399,219 $ lnsurance 133,000 $ 300,000 $300,000 $lnLeresL 900,000 $ 1,200,000 $ 1,200,000 $ uepreclauon/Amoruzauon 400,604 $ 784,307 $784,307 $Leasehold Lxpenses 630,069 $ 833,092 $883,092 $8ad uebL lncome 1axes 3,611,373 $ 21,170,188 $ 27,291,688 $1C1AL LxLnSLS: 16,473,249 $ 32,313,347 $ 67,311,328 $ ulerence (1,103,199) $202,178 $32,122 $number of auenLs 6,230 10,000 11,230number of vlslLs 27,300 103,730133,730CRITERION 2 18 COMPASSIONATE CARE FOUNDATION, INC.NEW JERSEY PAYROLL EXPENSE REPORTREQUIRED FORMAT!"#$%&$%'("!)*!+,%)&--%)*+."-+(./01%)&--%)*+."-'("!%2344'("!%2342'("!%2345L8SCnnLL CA1LCC8?# Cl l1L A?8CLL W/l8lnCL# Cl l1L A?8CLL W/l8lnCL# Cl l1L A?8CLL W/l8lnCLAdmlnlsLrauve and Cmce13 $ 971,840.33 131,837,231.99$ 131,877,282.68$ ulspensarv11 $ 278,999.94 11378,924.88$ 11386,946.12$ Cperauons ManaaemenL1 $ 77,940.00 1107,817.00$ 1113,207.83$ Crowlna101 $ 1,748,800.40 1833,768,088.26$ 2217,434,991.47$ laclllLv SupporL7 $ 128,860.80 8283,483.36$ 8292,933.08$ Shlpplna and 8ecelvlna14 $ 207,840.00 20720,079.00$ 21804,143.93$ SecurlLv28 $ 718,087.20 361,989,643.66$ 362,096,382.10$ Call CenLer4 $ 68,414.00 3169,023.88$ 3183,686.83$ LaboraLorv4 $ 77,940.00 11269,828.28$ 21639,817.23$ 8esearch3 $ 31,960.00 10227,931.20$ 20628,369.60$ avroll 1axes $ 417,910.88 1,133,368.31$ 1,414,688.36$ avroll 8eneLs $ 649,602.40 1,793,111.36$ 2,198,997.44$ Worker's Comp lns. $ 333,462.37 920,463.83$ 1,128,818.69$ 1C1ALS1863,731,638.31$ 30013,821,219.20$ 33919,402,487.43$ CRITERION 2 19 Measure3:Theapplicantshalldocumentitsexperiencerunninganotforprofitorganizationorotherbusiness(es).WeareproudofourBoardmembersexperienceworkingwithandmanagingnonprofits. TheBoardmembershaveoutlinedtheirexperiencewithnonprofitsintheirindividualCVs. Here is a partial list of nonprofits they have served: New Jersey Health Care Quality Institute New Jersey Health Care Payers Coalition The Epilepsy Foundation of New Jersey Newark AIDS Consortium The Leapfrog Group Gildas Club Self Insured Association of America National Robotics Education Association Healing Spaces The Long Island Power Authority State University of New York College at Old Westbury Foundation The Foundation of United Cerebral Palsy of Nassau County The Long Island 9/11 Memorial The American Association of Preferred Provider Organizations The Adler Aphasia CenterThe Health Enhancement Research Organization CRITERION 3 20 CRITERION3COMMUNITYINPUTANDAPPROVAL Compassionate Care has contacted municipal authorities and has a plan to solicit and incorporate meaningful community input into the project. We seek to be a good, responsible neighbor to the community, while providing much needed medical services to patients with debilitating medical conditions. Measure1:Inputfromthecity(s)ortown(s)wheretheapplicantsATCwouldbelocated.CompassionateCarehascontactedtheTownofBellmawrtosecureameetingwith municipalofficials,atwhichmeetingweexpecttoreviewtheprogramandproposed cultivation and patient care center operations with the governing body or its representatives.We are in the process of seeking a letter of recommendation. Appendix R: Letters of Recommendation Measure 2: Input from the general public regarding the suitability of the applicant and thegeneral standards for location(s) such as, distance from a school, daycare center or otherchildorientedlocation;distancefromacommercialshoppingdistrict,pharmacy;etc.CompassionateCareiscommittedtostrongpublicengagementandoutreachtothe community.Our community input plan has three goals:(i) to establish a process by which thecommunitycanexpressitselfregardingtheproject;(ii)toinformthecommunityabout medicalcannabisissues;and(iii)toensurethatCompassionateCare'sapproachgenuinely reflects the community's needs.To reach our goals, we anticipate doing one or more of the following, depending on input from municipal political leaders: 1.Identifyingabroadcross-sectionofcommunity-basedorganizationsand communityleaders,includingthoserepresentingindigentandtraditionally underservedandunderrepresentedresidents,tolearnhowresidentsand stakeholderscanbestreceiveusefulinformationthatenablesthemtoparticipate meaningfully.2.Identifyingandvisitingcivic,senior,andveteranorganizations,healthcare support groups, and community meetings to introduce our nonprofit organization, ourmission,andourvisionforthepatientcarecenter. Webelievethistypeof outreach establishes our legitimacy with the community and our vested interest in itswelfare. Wewilllistenreceptivelyandrespondtoanyconcernsaboutthe project.3.HoldingacommunitymeetingsoCompassionateCarecanintroduceitselfand present theprojectto anypartieswith thesamegoals. Again,ourpurposewould be to listen and find ways to be responsive. CRITERION 3 21 Measure2Responsecontd4.Completingouroutreacheffortswithafollow-uplettertocommunity stakeholders, letting them know that we heard their concerns and what procedures we will follow in responding to such concerns. 5.Inadditiontotheforegoinginitiatives,CompassionateCareiscommittedto engagingourpatientandresidentialcommunitiesonanongoingbasis.The Medical Advisory Board will always include at least two community members and onepatient(seeresponsetoCriterion4,Measure5).Wewillpartnerwithlocal community organizations to solicit volunteers for these positions. Appendix D: Distance to Sensitive Sites Appendix R: Letters of Recommendation CRITERION 4 22 CRITERION4PATIENTCARECENTERSPECIFICCONSIDERATIONS Measure1:Theapplicantshallprovideaplanforinventory,recordkeepingandsecuritywhichshowsanunderstandingofthetypesofrecordsthatshallbeconsideredconfidentialhealthcare information under New Jersey law and are intended to be deemed protected healthcareinformationforpurposesoftheFederalHealthInsurancePortabilityandAccountabilityActof1996,asamended[HIPAA].CompassionateCarewillusestandardindustrialsupplychaintrackingtoolstokeepproper inventorylevelsofproductsavailableforourpatients.Havinganoversupplyofinventory couldresultinproductdegradationandincreasedsecurityrisks,butanundersupplymight deny patients access to their medicine.One of the capabilities of our supply chain tracking system(describedinCriterion5,Measure3)istocontrolourinventoryandalsoanticipate future production needs. Under our system, each plant in our cultivation facility is assigned a unique, systematic serial number from the moment a cutting is taken.This serial number is enteredintooursecurecomputerdatabasesothatwearealwaysawareofthenumberand strain of plants within our facility. We are also aware of the current status of the plant (e.g., whetheritisinthevegetativeorfloweringgrowthstage).Thisinformationallowsusto forecast inventory levels for the future.If a patient inquires when a particular strain will be available, we can determine how many plants of that strain are in production, what stage of production they are in, and how long it will be before they are ready to harvest. After harvesting, when the medical cannabis is securely transported to our patient care center (see Criterion 5, Measure 1, Part 3), our supply chain tracking system is integrated with our high-securitydeliverycompanyandpatientcarecenterdatabase.Afteraproductfromour cultivation facility is placed in transit, the status of the package is updated to reflect pending deliveryconfirmation,andthenthestatusisupdatedwhenitisreceivedbythepatientcare center. Once we sell the product at the patient care center, information on the patient buying itisassociatedwiththeserialnumberoftheplant,sothereistraceabilityfromseedlingto sale. Even in the absence of physical communication, our technology allows us to retrieve current inventorylevelsfromwithinourpatientcarecentersothecultivationpersonnelaremade aware of any possible shortages or overages. CRITERION 4 23 Measure1ResponsecontdInventory Diversion Prevention To prevent diversion by patients or caregivers, we will take the following measures: At the time of each purchase, verify an individuals status as a qualified patient or caregiver with a valid identification card;Have the individual agree not to distribute cannabis to non-patients;Have the individual agree not to use the cannabis for other than medical purposes;Maintain membership records on site or have them reasonably available;Trackwhenmembersmedicalcannabisrecommendationand/oridentification card expires;Enforceconditionsofmembershipbyexcludingmemberswhoseidentification cardorphysicianrecommendationisinvalidorhasexpired,orwhoarecaught diverting cannabis for non-medical use;Refusetotransfermedicalcannabistoanypersonorentity,eveniflegally qualified,ifthereisreasontobelievesuchpersonorentityisusingcannabisfor non-medicalreasonsorislikelytodivertsuchmedicalcannabistopersonsor entities unauthorized to possess it under state law; and Monitortransactionsandprogramcontrolstopreventapatientand/orcaregiver from purchasing more than the legal amount of cannabis that a patient may receive in a month. Havingstrictguidelinesandpoliciesinplacetopreventdiversionisimportant.Oursupply chaintrackingsystemfollowseveryplantfromseedlingtosale,sowecanverifythe destinationofeveryproductCompassionateCaremanufacturesandsells.Thissystem allows us to:Preventshrinkagewithinthecultivationfacility,wherebyplantsarestolen,since each plant has a barcode and if it is missing we will know that a serial number is unaccounted for; Compareaverageyieldsofplants,wherebyifplantsinparticularareasare yielding less end product we can alert Security to a possible concern; and Requiretheshippingandreceivingdepartmenttoobtaindeliveryconfirmations foreachproductdelivered,andlogthatinformationwithourrecordkeeping system. Furthermore,allpatientcarecentersaletransactionswillbedonethroughapoint-of-sale cashieringsystem,andexcessinventorywillbesecurelystoredinvaultscompliantwith21 CFR 1301.72. CRITERION 4 24 Measure1ResponsecontdSinceregularinventoryandsupplychaintrackingiscrucialto preventingdiversiontonon-medical recipients, inventory will be manually performed every day in the patient care center by two background-checked employees to verify the accuracy of our computerized inventory management system.Manual inventory will also be performed in our cultivation facility on atleastamonthlybasistoensureallproducts,byproducts,anddiscardeditemsinour operationsareaccountedfor.Allinformationpertainingtoproduction,transferring,sales, and patients will be securely kept for a period of at least 7 years and be available for review by the State of New Jersey as required by law. Compassionate Care believes that by having strict guidelines aimed at preventing diversion, and creating an inventory tracking system that allows us to follow each plant from seedling to sale, we will be able to create a closed loop system where cannabis does not end up in the possession of a non-medical user. Recordkeeping and Security CompassionateCareplanstocreateandpreserveadequateandproperdocumentationofall of its activities through designated recordkeeping systems to support operational needs, allow foraccountability,andcomplywiththeStateofNewJerseysrequirements.Ourrecord keeping and software system will be designed and managed by our Information Technology (IT)Department.OurITDirectorwillmakesurealldataandinformationarehighly secureandbackedupinrealtime,severaltimesthroughouttheday.Datawillnotonlybe backed up to private servers but also to an off-site, highly secure server location to prevent a disaster from compromising Compassionate Cares database and recordkeeping. At a minimum, Compassionate Care will maintain a database that: Tracks all clients using their state medical cannabis identification card number; Anonymizes and secures patient and confidential records in an encrypted database to comply with HIPAA, New Jersey identity laws, and other applicable laws;Tracks all products manufactured, sold, and the frequency of such sales;MaintainsrecordsforthetotalnumberofpatientsaffiliatedwithCompassionate Care, along with their location, local jurisdiction permit number, and all affiliated business license numbers. Compassionate Care will limit access to our network and web portal using not only network passwords,butalsobyrestrictingIPaddressesandMACaddressestoaspecificcomputer.Thesystemwillbedesignedtodenyaccesstousersnotauthorizedtoviewcertain documentationandprotecttheprivacyofconfidentialinformation.Certainconfidential documentswillhavefileopenpasswordstoaddanadditionallayerofsecurity.Whenever possible the use of third party email, web, and data servers will be avoided. Compassionate Carewillprovidetrainingtointernalandexternalusersontheseprocedures.Wehave developed an HIPAA manual and training program. Appendix G: Operations Plan CRITERION 4 25 Measure1ResponsecontdTo meet the requirements set forth by the State of New Jersey and to meet the business needs ofCompassionateCare,anenterpriselevelapplicationwillbedeveloped.Thesystemwill have many users with corresponding access levels that fit into four basic groups. External Customers (many) Internal Customers (many) External Administrator (few) Internal Administrators (few) Customershaveverylimitedaccessandadministratorswillhavemoreexpansiveaccessto oursystems.Outsidevendorsandpatientsaredescribedasexternalcustomerswiththe lowestaccesslevelassignment.CompassionateCaresvariousdepartmentsandemployees aredescribedasinternalcustomers,withthesecondlowestaccesslevel.TheStateofNew Jersey,ourthirdpartylabtestingservice,andotherregulatorybodieswillbedefinedas external Administrators. They will be given sufficient access to meet the requirements set out intheCompassionateUseMedicalMarijuanaActandassociatedrules.Internal Administrators include the Board of Directors and department heads, and these will be given thehighestlevelofaccess.Passwordswillbechangedfrequentlyandaccesslevels reassigned as necessary. The system will manage a master database through modules defined for a specific reporting purpose.Onemodulemaytracktheone-plantflowsystemthatdisclosesthestageand destinationofallplantsfromcloneorseedtofinalproduct.Uniquetracking,testing, barcodes,labeling,andpackagingwillgreatlyreducetheriskofdiversiontoothermarkets andcounterfeitingoftheCompassionateCarebrand.Theone-plantflowmodulemaybe used by other modules, such as a product availability forecast module. Data entry from our internal customers will be routinely updated as any status changes occur. CompassionateCaredepartmentaldirectorswillmeetregularlytodeterminehowsystem modules should be updated or if new modules need to be created. CompassionateCarewillallowtheStateofNewJerseytohaveaccesstothecultivation facilitysbooks,records,accounts,inventorymanagementsystem,andanyandalldata relevanttoourpermittedactivitiesforthepurposeofconductinganauditorexamination.With our record keeping and software design, Compassionate Care should be able to produce recordsinsyncwithourvariousdepartmentsinstantaneouslyoratleastwithin24hours,in theabsenceofunforeseencircumstancesoccurring.CompassionateCareshallbeprepared forquarterlyfinancialrecordauditsbytheDHSSorotherresponsiblestateandlocal authorities. Appendix H: Security Plan Appendix J:The Health Insurance Portability and Accountability Act (HIPAA) Manual Appendix K: Human Resources Manual CRITERION 4 26 Measure 2: The applicant shall submit a description of its proposed program for providingcounseling and educational materials regarding methods of administration and researchstudies on health effects of medicinal marijuana to registered qualifying patients and theirregistered primary caregivers. The applicant shall submit a description of its historicalrelationshipwithclinicalorresearchactivities,ifpresent.Compassionate Care embraces a patient-centered care coordination model influenced by the AgencyforHealthcareResearchandQualitys(AHRQ)definitionofapatient-centered medical home. In this section we give a basic overview of our care model and then describe how Compassionate Care will implement elements of this model in our clinical practice.A patient-centered medical home has the following characteristics: Patient-centered care Comprehensive care Coordinated care Superb access to care A systems-based approach to quality and safety Overview Patient-Centered Care Amedicalhome practice provides patient-centeredcarebasedon relationships andoriented towardthewholeperson.Partneringwithpatientsandtheirfamiliesrequiresunderstanding andrespectingeachpatientsuniqueneeds,culture,values,andpreferences.Themedical home practice actively supports patients in learning to manage and organize their own care at the level the patient chooses. Recognizing that patients and families are core members of the careteam,medicalhomepracticesensurethatpatientsarefullyinformedpartnersin establishingpersonalizedcareplans.Patient-centeredcarerequiresaClinicalCare Coordinator (CCC) who is a skilled advanced practice nurse working in partnership with the patients primary care and/or specialty doctor. Comprehensive Care Amedicalhomepracticeprovidescomprehensivecare,assistingpatientsinmeetingtheir physicalandmentalhealthcareneeds,includingpreventionandwellness,acutecare,and chronic care. It needs to address various phases of a patients lifespan, including end-of-life care.Comprehensivecarerequirescareproviderstoworktogetherasateam.Thisteam might include physicians, advanced practice nurses, physician assistants, nurses, pharmacists, nutritionists, mental health workers, social workers, educators, and care coordinators. TheCCCplaysacrucialroleincomprehensivecare.Heorshemustworkcollaboratively with an interdisciplinary team and have the broad-based knowledge and experience necessary to handle most medical needs of the patient and to resolve conflicting recommendations for care. CRITERION 4 27 Measure2ResponsecontdCoordinated Care Amedicalhomepracticeassistspatientsincoordinatingcareacrossallelementsofthe broaderhealthcaresystem,includingspecialtycare,hospitals,homehealthcare,and community services and supports. Such coordination is particularly critical during transitions between sites of care, such as when patients are being discharged from the hospital. Medical home practices excel at building clear and open communication among patients and families, the patients primary care medical home, and members of the broader care team. Superb Access to Care Amedicalhomepracticedeliversaccessibleserviceswithshorterwaitingtimesforurgent needs, enhanced in-person hours such as flexible appointment times or physician availability seven days a week, around-the-clock telephone or electronic access to a member of the care team,accessfornon-visitrelatedpatientneeds,andalternativemethodsofcommunication suchasemailandtelephone.Medicalhomepracticeisresponsivetopatientspreferences regarding access and provides for patients with special communication needs. A Systems-Based Approach to Quality and Safety Amedicalhomepracticetakesasystemsapproachtoqualityandsafety.Itemploys evidence-basedmedicineandorientsitspracticetopopulation-specifichealthmanagement. Usingclinicaldecisionsupporttoolstoguideit,thesystemsapproachsharesdecision making with patients and families, engaging in performance measurement and responding to patient experiences and satisfaction. Sharing robust quality and safety data and improvement activities publicly is an important marker of a system-level commitment to quality. Implementation Before the Visit Physicianandpatientdiscusstherisksandbenefitsofcannabisforthepatients debilitating medical condition. Ifthephysicianandpatientagreethatcannabismaybeanappropriatetreatment forthepatient,thephysicianentersthepatientinthePhysicianRegistryfor Medicinal Marijuana. The patient registers with New Jersey MMP, designating a caregiver if so desired. Patient obtains authorized personal identification card.Patientand/orauthorizedcaregivervisitsCompassionateCarespatientcare center and meets with a CCC. CRITERION 4 28 Measure2ResponsecontdSharing InformationOneofthemostimportantrolesoftheCCCistoprovideinformation,includinganswering patientsquestionsaboutadiseaseoritssymptoms,discussingthephysicians recommendationandthepatientsdecisiontotrymedicinalcannabis,andexplainingthe appropriate use and methods for taking medical cannabis. Information is central to patients ability to manage well, but information alone is not enough. The goal in sharing information forself-managementsupportistoensurethatpatientsnotonlyunderstandtheinformation but are also prepared to act on it in daily life. Telling patients what they need to know is not a guarantee that they will be able to use the information, and conveying all critical information duringashortvisitmaynothavethedesiredoutcomeifpatientsarenotabletounderstand anduseit.TheCCCwillaskpatientstocompleteahealthriskassessment(described below).Wethenwillinterpretthatinformationtoconfirmthepatientsunderstandingof healthy patient behavior. Setting Healthy Goals Studiesshowthatpatientsrelyonprofessionaladviceindetermininghealthgoals. Collaborativelysettinghealthimprovementgoalswithpatientsisanimportantstepin motivatinghealthybehaviors.Usingagenda-settingtools,CCCswillintroducethe collaborative process of establishing healthy goals. It is important that patients priorities in goalsettingleadthedecisionaboutwhichgoalsareestablished.Byachievingsmall successes toward a goal that is important to them, patients will enhance their confidence and senseofcontrolinmanagingtheirillness,andthiswillpavethewaytoachievinggoalsin other areas. Goal Setting, Action Planning, and Problem Solving Helpingpatientsknowwhattodotostayhealthyisimportant,butthegoalofself-managementsupportistohelpthemadoptthebehaviorsthatwillkeepthemhealthyover time.Motivatingandcoachinghealthybehaviorsisonemethodofsupportingself-management that can be done very effectively by CCCs. Moreover, for patients with chronic conditionsrequiringmedicalcannabis,whilesettinghealthgoalswiththeirdoctorisan important step, few achieve their goals without more specific planning. Additional behavior changecoachingisneededtodeveloppatientconfidenceinreachinggoals.TrainedCCCs caneffectivelyworkwithpatientstodefinetheiractionplans.Withpractice,tasksrequired tosupportpatientsandfamiliessuchasmakingaspecificplanofaction,anticipating barriers,andconnectingthemwithcommunityresourcescanbetheresponsibilityof members of the care team other than the physician, often with equivalent results. CRITERION 4 29 Measure2ResponsecontdPatient Education and Skill Building Patientsandfamiliesneedclearinformationtounderstandthesignsandsymptomsofthe disease(s)andtreatments,andtrainingtobuildtheskillstomonitorclinicalindicatorssuch aswasting,nausea,andintraoculareyepressure.Thisclinicalcontentdistinguishesself-managementeducationfromself-managementsupport,whichhelpspeoplemakebehavior changesandsustainthemovertime.CCCswithappropriatetrainingcanprovideself-management education.Primary care teams may have difficulty finding time and appropriate staff to provide patient education sessions in the course of an office visit. CCCs will provide justtherightinformationinresponsetopatientneedsorquestions,increasingthepatients understandingandskillsincrementally.Forin-deptheducation,CCCswillreferpatientsto communityprogramsofferedbypublichealthentitiesorhospitalsthatareanunderused resource.Psychosocialandemotionalstressors,aswellasphysicalsymptoms,shouldbe considered in these programs. Patient Engagement in the Collaborative Care Process PatientarrivesandregistersatCompassionateCareandisgreetedbyreception staffforhis/herscheduledorunscheduledappointment.PatientprovidesNJ Medical Marijuana identification card and secondary form of identification.Reception staff use warm handoff introductions and explain CCC team member role to patient. TheCCCwelcomespatient,escortshim/hertoconsultationroom,andguidesthe patientthroughanintakequestionnairecoveringinformationwearerequiredto reporttotheDepartment,suchaspatientdemographics,intractablemedical condition, and the current severity of the patients pain and other symptoms. The CCC then explains that Compassionate Care wishes to collect additional data for research and quality improvement purposes and requests the patient consent to participationinavoluntarynewpatientHealthRiskAssessment(HRA;contents discussed below). TheCCCreviewsthepatientsrequestformedicalcannabistoevaluateits appropriatenessandmakealternativetreatmentsuggestionsifdeemednecessary.Ifpatientconsents,CCCwillimmediatelycontactpatientsprimaryorspecialty care provider to suggest an alternative treatment plan if medical cannabis does not appear to be clinically indicated.TheCCCandpatientreviewgoalstoimprovepatienthealthandhelpthemmake action plans that build confidence in their ability to reach these goals. The CCC uses patient education materials to provide learning and support for the patient.The CCC uses ask-tell-ask to provide just the right information at just the right time and close the loop to ensure patient knows how to use the information. TheCCCcollectsfeedbacktoprepareapersonalhomecareplanthatincludes goalsandactionplanstoensurepatientandfamilyknowwhattodowhenthey leave the visit. CRITERION 4 30 Measure2ResponsecontdAfter the Visit Ongoing Follow-Up Sustaininghealthybehaviorsrequirescourageandtenacity,mostofteninvolvingsmall, incremental changes that build over time into bigger successes. Even the best plans of action require adjustment to work effectively. Certain strains of medical cannabis may produce side effectsornotproducethedesiredeffect,requiringfurthersupportandexplanationor alterations to make the plan workable. For all of these reasons, making regular contact with patientsaftereachvisitorchangeintreatmentiscentraltosustainingpositivechange.By utilizingpatientexperienceassessmentandreportingtools,wewillengagethevoiceofall patients throughout the continuum of care. Patient Experience Measurement and Outcomes Evaluation Everythreemonths,orasclinicallyindicated,aCCCwillrepeatsymptom severity assessments to monitor changes from baseline in patients pain and other symptoms Compassionate Care has selected a state-of-the-art survey collection tool to obtain additionalpatientexperiencefeedbackandpatientreportedoutcomesthatwill enablefurtherqualitymeasurement,continuousimprovement,andcomparative effectiveness evaluations. TheCCCswillorganizefollow-upsupporttohelppatientsustainhealthy behaviors between visits. TheCCCswillextendcareintothecommunitybylinkingpatienttocommunity programs. Measure3:Theapplicantshallprovideanacceptablesafetyandsecurityplan,includingstaffingand site, and a detailed description of proposed security and safety measures whichdemonstratecompliancewiththeRulesRelatedtotheMedicinalMarijuanaProgram.Thepatientcarefacilitywillbeafullysecuredbuilding,equippedwithperimeterfencing, on-siteemployeeandpatientparking,sufficientarealighting,surveillance,electronic keycardaccess,on-siteandparkinglotsecuritypersonnel,andalarms. Employeeswillbe fully trained on security procedures and Compassionate Care will conduct periodic safety and training drills. Our Security Plan provides details as to specific proposed security and safety measuresthatdemonstratecompliancewiththeRulesRelatedtotheMedicinalMarijuana Program. Appendix H: Security Plan CRITERION 4 31 Measure 4: If the applicant proposes to cultivate and dispense at two separate physicallocations,theapplicantshallprovideanacceptabledeliveryreceiptplan,includingmeasuresto ensure sanitary medicinal standards, security and inventory control, for the receipt ofmedicinal marijuana from the cultivation site by ATC staff at the dispensing site. Thedelivery receipt plan shall demonstrate compliance with the Rules Related to the MedicinalMarijuanaProgram.Delivery from cultivation facility to patient care center will be secure.The inventory control plan is provided in the Security Plan. Appendix H: Security Plan Measure5:TheapplicantshallsubmitadescriptionofitsMedicalAdvisoryBoard,includingbylaws, setting forth the names and expertise of its members and describing how it willfunctionwithintheorganizationalstructureoftheATC,consistentwiththeRulesRelatedtotheMedicinalMarijuanaProgram.Forpurposesofthisrequirement,itisnotnecessaryforthe applicant to provide the name of the Medical Advisory Board member who is aregisteredqualifyingpatient.The Medical Advisory Board will be made up of physicians, nurses, other licensed healthcare providers,communitymembers,andpatients.Wehaverecruitedanumberofprestigious physicians and PhDs to serve on the Board. Many of our Board Advisors are affiliated with one or more acute care general hospitals located in and around our patient care center area.If wearegrantedapermit,wewillasktheNewJerseyStateNursesAssociationtonominate nurses to the Board. As patients are enrolled and develop experience we will recruit patients to the Board.Once we have finalized the locations for our patient care centers we will recruit localcommunitymemberstotheBoardaswell.OurbylawswillrequirethattheMedical AdvisoryBoardincludeatleasttworesidentsofthecommunityandoneactivemedical cannabis patient. The duties of the Board will include but not be limited to: Setting protocols for the patient care centers, Monitoring and modifying the patient care center treatment protocols as needed, Assistingindirectingandmonitoringresearchontheclinicaleffectivenessand safety of cannabis, and Providing educational outreach to other providers on the use of the drug. The members of the Board and their credentials are as follows: 1.T.PatrickHill,Ph.D.isSeniorPolicyFellow,EdwardJ.BlousteinSchoolof PlanningandPublicPolicy,Rutgers;ClinicalResearchEthicsConsultant,The CancerInstituteofNewJersey;andClinicalEthicsConsultant,TheNeonatology DivisionUMDNJ-RobertWoodJohnsonMedicalSchool.Dr.Hillwasaskedto join the Board for his expertise in biomedical ethics. CRITERION 4 32 Measure5Responsecontd2.RonaldLibrizzi,DOisChiefofMaternal-FetalMedicineandClinicalAssociate ProfessoratThomasJeffersonUniversitySchoolofMedicineandChiefof Maternal-FetalMedicineatVirtualHealthSystem inNewJersey.Dr.Librizziis Chair of the Osteopathic Board of Obstetrics and Gynecology and a past President oftheAmericanCollegeofObstetricsandGynecology.Heservesthestateasa commissionerontheNewJerseyMandatedHealthCareAdvisoryCommission.Dr.LibrizziwasaskedtoserveontheBoardforhisknowledgeofissues concerning pregnancy, womens health issues, and health care in New Jersey. 3.Suzanne M Miller, PhD is Professor at Fox Chase Cancer Center where she is the Director of the Psychosocial and Biobehavioral Medicine Program, Director of the BehavioralCenterofExcellenceinBreastCancer,DirectoroftheIntervention Development and Measurement Core of the Cancer Information Service Research Consortium, and Director of the Behavioral Research FacilityDr. Miller has been asked to join the Board for her expertise incancer, the psychosocial dynamics of patient care, and research.4.Christopher Olivia is the President of West Penn Allegheny Health System and the formerPresidentofCooperUniversityHealthSysteminCamden.Heisalsoa ProfessorattheUniversityofPennsylvaniasWhartonSchool.Dr.Oliviahas beenrecognizedasoneofthenations50mostpowerfulphysicianexecutivesby ModernHealthcareandModernPhysicianmagazines.Dr.Oliviahasbeenasked tojointheBoardbecauseofhisspecificexperienceinservingtheindigent population of New Jersey. His specialty is ophthalmology. 5.AlfredF.Tallia,MD,MPHisProfessorandChair,DepartmentofFamily MedicineandCommunityHealthattheRobertWoodJohnsonMedicalSchool, University of Medicine and Dentistry of New Jersey. Dr. Tallia was asked to join the Board for his expertise in family medicine and in physician education.Measure6:Theapplicantshallsubmitaplantotrackandanalyzedataincludingbutnotlimitedtopatientoutcome,utilizationandtrends.ThesuccessofCompassionateCarespatient-centeredmedicalhomecaremodelis predicatedontheongoingcollectionandanalysisofpatientdata(fordescriptionofthe medical home model see response to Criterion 4, Measure 2, Part 1).We have asked several well respected medical researchers to be on our Board and on our Medical Advisory Board.From these groups we will form a Research Committee to direct our research. CRITERION 4 33 Measure6ResponsecontdIntheinitialphaseofouroperations,wewillchoosethreestrainsofcannabistocultivate baseduponourknowledgeandourassumptionsaboutthepatientpopulationthatwillbe seeking care.It is impossible to forecast which types of eligible patients will actually elect to enterourprogram,andcurrentlythereisnoadequatescientificliteraturedocumentinghow differentstrainsaffectdifferentclassesofpatients.Mostofwhatisknownaboutmedical cannabiscanbecharacterizedascraftknowledgebasedonindividualpractitioners experienceandnotsystematicstudies.Itiscentraltoourmissionthatwewilldevelopa more scientific knowledge base, which we will use to refine our practice and better educate ourpatients,theirphysicians,thewidermedicalcommunity,regulators,andthepublic.To generatethenecessarydataforthisenhancedknowledgebase,CompassionateCarewill follow the rigorous data collection protocols described below. Data Collection ProtocolsLevel 1 Data Collection: Routine Record Keeping (applies to all patients) Upon enrollment, patients and caregivers will be issued a Registry Identification (ID) Card withauniqueRegistryIDnumber(RIN).CompassionateCarewillusetheRINtotrack an individuals visits and transactions at our patient care center.In order to comply with the ATC reporting requirements, we will, at the time of registration, conduct baseline symptom severityassessmentsandcollectdataonpatientdemographics,thepatientsdebilitating medical condition, and such other information as the Department may require. Allpurchasesmadebyapatientorthepatientscaregiverwillbeidentifiedbyusingthe qualifying patients RIN.Whenever a patient or caregiver has a CCC encounter or initiates a transactioninourpatientcarecenter,ourpersonnelwillreviewthepatientstransaction history,includingthedateofpriorpurchases,thecannabisstrainspurchased,theformsof cannabis purchased (dried leaves and flowers, lozenges, or topical formulations), the amount ofcannabispurchased,andthepatientscurrentpurchaseeligibilitylimit(apatientmay purchase no more than two ounces of usable marijuana in a 30-day period).Details of new transactions will be documented at the time of sale, and the patients transaction history will beimmediatelyupdated.Painandothersymptomseveritymeasureswillberepeatedata minimum of every three months. Usingtheseroutinerecords,wewilldevelopacomprehensivebasicknowledgeofthe products patients are using for different conditions, the forms and amounts of cannabis they areconsuming,andthekindsofclinicaloutcomestheyareexperiencing.Basedonthese analyses, our clinicians will have a better foundation for making recommendations to patients as to how they should use the product depending on their underlying disease and symptoms.Thesedatawillalsohelpustoidentifythosestrainswhichmightbecontra-indicatedfor certain conditions or which present larger safety concerns. CRITERION 4 34 Measure6ResponsecontdLevel 2 Ongoing Clinical Evaluation (applies to consenting patients) Attheirfirstvisittothepatientcarecenterandperiodicallyafterwards,allpatientswillbe askedtoconsenttoparticipateinadditionaldatacollectionbeyondthatrequiredbythe MMP.Withthepatientsconsent,wewillcollectabriefmedicalhistoryincludingcurrent andpriorpharmaceuticaltreatmentsandasummaryofhisorhercurrent(orbaseline) medicalconditions.Thereafterwewillcollectpatientexperiencedatausingoursurvey technology and join this with the patients consumption history.By systematically gathering patientself-reportsontherisks,benefits,andoverallefficacyoftheproduct,aswellas assessmentsofourserviceandeducationalefforts,wewillbeabletodomorein-depth analysis of different strains comparative effectiveness and more intensive continuing quality improvement of our products and services. Level 3 Special, In-depth Clinical Research Partnerships with Clinicians and Other Researchers Inadditiontocollectingthedatajustdescribed,wewillalsoseekoutpartnerstoconduct more detailed clinical investigations of medical cannabis.We anticipate conducting studies where,withpatientconsent,wewillcollectcompletemedicalhistoryandpriortreatment datafromthepatientsmedicalrecords,andwewillalsocollectclinicalassessmentsofthe effectsofcannabis.Thiswillgiveusaccesstopatientoutcomedatabeyondpatientself-reports and enable more rigorous analyses of the risks and benefits of cannabis for different types of patients.Drawing on the networks of our Board of Directors and Medical Advisory Board,wewillrecruitspecialiststoexploreindepththetherapeuticeffectsofcannabisfor special populations, such as children or pregnant women, or for particular conditions, such as Crohns disease or end-stage cancer. CRITERION 5 35 CRITERION5CULTIVATIONSPECIFICCONSIDERATIONS Measure1:Theapplicantshallprovideanacceptablesafetyandsecurityplan,includingstaffingand a detailed description of proposed security and safety measures which demonstratecompliancewithRulesRelatedtotheMedicinalMarijuanaProgram.SupportingdocumentsshouldbeincludedasAppendixH.I.The description shall include a detailed floor plan for the ATC cultivation site, whichindicates location and design standards and performance specifications of securitydevicestobeutilized.II.The applicant shall provide a plan to involve and coordinate with local lawenforcement authorities on security and safety issues, and identify the lawenforcementofficialscontactedduringthedevelopmentofthisplan.III.If the applicant proposes to cultivate and dispense at two separate physicallocations,theapplicantshallprovideanacceptabledeliveryplan,includingmeasuresto ensure sanitary medicinal standards, security and inventory control, for thedelivery of medicinal marijuana from the cultivation site to the dispensing site. Thedelivery plan shall demonstrate compliance with the Rules Related to the MedicinalMarijuanaProgram.IV.All responses shall be utilized for internal Department review only and shall not beavailableforpubliccommentorreview.CompassionateCareunderstandsthatourmostimportantassetsareourpatientsand employees,andouroverridingresponsibilityistoprovidefortheirsafetyandsecurity.We have consulted with Dunbar, a leading nation-wide security company, and with other security experts,tomakesureoursecurityplanconsidersallpossiblethreatswhileutilizingtodays mostup-to-datetechnologytocounteractthem.Wehavedevelopedaplanthatmeetsor exceeds current standards for policing and securing the type of facility we will be operating.Wehavedividedoursecurityplanintotwocomponents:CultivationFacilitySecurityand Operational Security. The key elements of cultivation facility security are: Physicalinaccessibilityofthesite(fencedwithlimitedingress)andoptimal lighting; Around-the-clock protection and surveillance by armed security personnel; Comprehensive video surveillance, monitored both on site and remotely; Tight access control, both to the facility and to the various areas within it, through keycard and password restriction; Electronic intrusion detection; alarms, both silent and audible; panic buttons; and Immediate, selective or total lockdown capability. Key elements of operational security are: CRITERION 5 36 Measure1ResponsecontdStrictcontrolofproductionandcomprehensivetrackingofallproductsinall stagesofproduction,includingexcess,returned,ofsubstandardproductdestined for destruction rather than sale;Armored car delivery to dispensary; Transactional security, including cashless operations at the cultivating facility; Comprehensive IT security; Strict access control for guests, media, and other visitors; Thoroughvettingofemployeesandcontractors,includingextensivebackground checks and probationary evaluation; and Comprehensive and ongoing training of all staff in both routine and extraordinary security procedures, emergency response procedures, and disaster preparedness. Appendix H: Security Plan Measure2:Theapplicantshallprovideadescriptionoftheenclosed,lockedfacilitythatwouldbe used in the cultivation of medicinal marijuana, including steps to ensure that themedicinalmarijuanaproductionshallnotbevisiblefromthestreetorotherpublicareas.Iftheenclosedsiteisagreenhouse,identifymaterialsusedinconstructionofpanels.Glass,fiberglass, metal, or polycarbonate panels shall be used in construction of the facility;polyethylenefilmisnotpermissible.Describewindowandventcovers.The masonry-constructed building is 127,564 square feet, on a lot of approximately 5acres.Thebuildingisconstructedofsteelandconcreteblock. The12"thickexteriorperimeter wallsprovideasolidbaseforsecurity. Allwindows willbefittedwithsteelgratesfor security. Theremainderofthebuildinghasnowindows,andtheexteriordoorshaveno external accessthey exist for egress purposes only.These doors have mechanisms only for exitingthefacility,withnoexteriorhandlesorhinges. Ifanintrudertriedtoenterthe facility, he would not be able to use the doors as an entry point.Since the only windows will be fitted with steel grates and there are no doors for exterior entry, potential intruders would have great difficulty gaining unauthorized access.Limiting the access through these existing design elements deters and reduces the likelihood of unwanted intrusion.The entire facility istobefencedoff,andallpartiesenteringthegroundswillneedtogothroughasecurity gate. This also greatly reduces the likelihood of unauthorized access. CRITERION 5 37 Measure 3: The applicant shall demonstrate an ability to provide a steady supply of medicinalmarijuanatoregisteredqualifyingpatients.Measure3I:Theapplicantshallprovideastartuptimetablewhichprovidesanestimatedtimefrom issuance of an authorization for operation to limited operations to full operation, aswellasthebasisfortheseestimates.The planned startup timeline for our cultivation facility is summarized in the following table showingthedatesofthemostsignificantconstructionandhorticulturalmilestones.Upon award of an ATC permit, Compassionate Care is prepared to immediately begin construction planningandweexpecttohaveconstructioncompletebyJuly29.TheGeneralContractor will complete the primary growing areas first, so that horticultural activities can begin while construction in other areas is ongoing.We will start growing in the facility on May 27, we expectfirstharvestonAugust1,andproductwillbeavailableforsalebyAugust15.The datesshownherearesubjecttochangebasedonfactorssuchasunexpectedshortagesof construction materials, permitting and zoning delays.CRITERION 5 38 Measure3IResponsecontd MonthDayConstruction MilestoneHorticultural Milestone 22 Construction commences: mobilization of construction crews, tools, machinery and equipment; review and finalization of specifications and prints March 28 Begin building preparation: obtain construction permits; order and release of specified construction materials and equipment 4 Layout of wall panel system, electrical work and mechanical work 11 Begin build out of flowering rooms including wall and ceiling panels, electrical work, mechanical work, sprinkler system, and doors April 27 Flowering room wall and ceiling panels complete.Electrical and mechanical to work in conjunction with same time schedule.Concrete floor finishing, installation of bumper, pipe guards and Frasier racks Begin growing May 30 Begin build out of non-flowering room process areas, exterior doors, docks, and dock levelers 1 Start mother plants. Move production plant to vegetative cycle 15 Move production plants to flowering cycle 20 Begin build out of office (employee) areas including lockers, bathrooms and cabinetry June 29Start alternating month cycle 15Completion of build out in all areas 18Final touch up July 29Completion of all construction work 1Harvest first crop 15First product available for sale August CRITERION 5 39 Measure 3II: The applicant shall describe its knowledge of (and experience with) organicgrowing practices or agricultural growing practices to be used in their cultivation ofmedicinalmarijuana.The Organic Foods Production Act of 1990 prohibits the following production practices and materials.CompassionateCarewillmakeeveryefforttouseproductsthatarecompliant with the intent of these regulations. Prohibited crop production practices and materials Seed,Seedlings,andPlantingPractices.Forafarmtobecertifiedunderthis chapter,producersonsuchfarmshallnotapplymaterialsto,orengagein practiceson,seedsorseedlingsthatarecontraryto,orinconsistentwith,the applicable organic certification program. Soil Amendments. For a farm to be certified under this chapter, producers on such farm shall not: oUseanyfertilizerscontainingsyntheticingredientsoranycommercially blendedfertilizerscontainingmaterialsprohibitedunderthischapteror under the applicable State organic certification program; or oUseasasourceofnitrogen:phosphorous,lime,potash,oranymaterials that are inconsistent with the applicable organic certification program. CropManagement.Forafarmtobecertifiedunderthischapter,producerson such farm shall not: oUse natural poisons such as arsenic or lead salts that have long-term effects andpersistintheenvironment,asdeterminedbytheapplicablegoverning State official or the Secretary; oUseplasticmulches,unlesssuchmulchesareremovedattheendofeach growing or harvest season; or oUse transplants that are treated with any synthetic or prohibited material. Title7,Part205oftheNationalOrganicsProgramprohibitsthefollowingsubstances, methods, and ingredients in organic production and handling. Compassionate Care will make every effort to use products that are compliant with the intent of these regulations. To be sold or labeled as 100 percent organic, organic, or made with organic (specified ingredients or food group(s)), the product must be produced and handled without the use of: CRITERION 5 40 Measure3IIResponsecontdSynthetic substances and ingredients, except as provided in 205.601 or 205.603; Nonsynthetic substances prohibited in 205.602 or 205.604; Nonagriculturalsubstancesusedinoronprocessedproducts,exceptasotherwise provided in 205.605; Nonorganicagriculturalsubstancesusedinoronprocessedproducts,exceptas otherwise provided in 205.606; Excluded methods, except for vaccines: provided that the vaccines are approved in accordance with 205.600(a); Ionizingradiation,asdescribedinFoodandDrugAdministrationregulation,21 CFR 179.26; and Sewage sludge. Hydroponics vs. Organics CompassionateCarewillbeusingefficienthydroponiccultivationtechniquestoproduce highqualitymedicalcannabisfor NewJerseyspatients.Considerabledebatesurroundsthe value of organic versus hydroponic cultivation methods.When weighing the pros and cons of the two cultivation methods it is important to recognize the reasons that organically grown products are gaining popularity. Consumers want products that are not tainted by hazardous chemicals or poisons and that do not harm our fragile ecosystems.Fundamental principles of organic cultivation are: Avoiding chemical pesticides through the use of natural pest control measures, Caring for soil through composting and erosion control, and Moderation of nutrient application. Compassionate Cares efficient hydroponic cultivation processes are in alignment with these principles.Compassionate Care will avoid chemical pesticides through a holistic approach to pest management that emphasizes preventative measures;CompassionateCarewillusesoil-lesshydroponicsandwillincinerateallunused plant material under a limited-waste policy; Compassionate Care will adhere to strict nutrient schedules and will utilize highly efficient nutrient dosing technologies to minimize, if not eliminate, nutrient waste. CRITERION 5 41 Measure3IIResponsecontdThroughefficienthydroponicprocessesandtheuseofpurehydroponicnutrients Compassionate Care will be able to minimize use of substances that would not be allowed by the Organic Foods Production Act of 1990, by the regulations in Title 7, Part 205 of the Code of Federal Regulations, or by the National Organic Program. Through detailed product safety and laboratory testing protocols (described in our Product Safety Plan) Compassionate Care willensurethatallproductsarefreeofharmfulyeasts,molds,bacteria,andchemical residues. These measures will produce a product far superior to org

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