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REV 01/2017November 2016For manufacturers to the Pharmaceutical Segment distribution supply chainManufacturer reference manual

IndexSection 1:Introduction.3Section 2:Understanding and working with Cardinal Health.4Who to contact.5Section 3:Getting set up with Cardinal Health.6New manufacturer set up process.6New item set up process.6Section 4:Filling Cardinal Health orders.7Purchase orders.7Electronic Data Interchange (EDI).8Product Availability Report.10Item and manufacturer record maintenance and 60 day back order policy.13Section 5:Delivering Cardinal Health orders.14Transportation.14Product packing and shipping requirements.16DC listing.18Section 6:Returned goods and recalls.19Section 7:Collaborating and improving processes.21Section 8:Drug Supply Chain Security Act.30Section 9:Conclusion.32Attachment A: New manufacturer set-up worksheet.34Attachment B:DSCSA Trading Partner Status/Authorized Trading Partner letter .35Attachment C: Manufacturer Portal Terms Registration Form.46Attachment D: Consumer Health new item set up forms.37Attachment E:Preferred inbound carriers .40Attachment FProcurement and fulfillment statistics scorecard.41Attachment G: Manufacturer pricing services (chargeback) requirements.42(Click on section title for hyperlink to section)REV 01/2017Manufacturer reference manual 2

Section 1: IntroductionThe Cardinal Health Manufacturer Reference Manual isa policy document governing the relationship betweenthe Cardinal Health Pharmaceutical Distribution Businessand its manufacturers. This manual provides guidanceregarding Cardinal Health operational expectations tomanufacturers/suppliers of pharmaceutical productsdistributed by the pharmaceutical segment ofCardinal Health. These policies were constructed toallow Cardinal Health and its manufacturers to meetthe commitment to excellence expected by our mutualcustomers while reflecting an ongoing commitmentto conduct business in a manner that respects thecontributions of all stakeholders. The policies andstandards contained within may be updated at anytime and it is therefore important that manufacturersperiodically review the current revision of this manualfor updates.REV 01/2017Manufacturer reference manual 3

Section 2Understanding and working with Cardinal HealthPharmaceutical SegmentOur Pharmaceutical segment consolidates pharmaceuticals from hundreds of manufacturers into site-specific deliveries to retailpharmacies, hospitals, mail-order facilities, physician offices, surgery centers and long-term and other alternate care facilities.Through this segment, Cardinal Health offers the most secure, efficient and economical source of pharmaceuticals, specialty plasmaproducts and value-added services to healthcare providers and pharmaceutical manufacturers. Cardinal Health also operates the world’slargest network of nuclear pharmacies and is expanding its positron emission tomography (PET) agent manufacturing capabilities tosupport new drug development and the future of personalized medicine. In addition, about 200 hospitals across the U.S. outsource themanagement of their inpatient pharmacy to Cardinal Health because of our proven expertise and track record of improving efficiencyand safety within inpatient pharmacies.Products and services Access services Pharmacy management solutions Cold Chain – Refrigerated Pharmaceutical Tote Packagingfor Pharmacy Deliveries Scientific and Regulatory Consulting (Beckloff Associates) GPO contracts and services (VitalSource GPO) Healthcare Analytics and marketing communications Specialty Pharmaceutical Distribution –this Manufacturer Guide is applicable to these businesses Hospital Quality at Home Specialty Pharmacy (OncoSource Rx) LEADER brand pharmacy services The Medicine Shoppe Medicap Pharmacy franchises Third Party logistics services SonexusHealth Nuclear Pharmacy Services Pharmaceutical distribution –this Manufacturer Guide is applicable to these businessesREV 01/2017Manufacturer reference manual 4

Section 2Understanding and working with Cardinal HealthWho to contactRequest typeContact information (email, phone, etc.)Accounts ric new item set-uprxgenerics@cardinalhealth.comBrand new item set-upGMB-DUB-Rx Brand-New Items@cardinalhealth.comBrand new vendor set-up .comor DSA ManagerConsumer Health new item set-upcardinal.marketgate.comConsumer Health new manufacturer omContract pricing and membership ts supplied by manufacturersContracts@cardinalhealth.comCase pack changes – genericsYour Cardinal Health BuyerCase pack changes – brandDSA ManagerCase pack changes – Consumer HealthCategory ManagerProduct availabilityCardinal Health buyerProduct recallsGMB-HSCS-P-Recalls@cardinalhealth.com, fax is: 614.553.5671Electronic Data Interchange (EDI)GMB-DUB-VendorEDI@cardinalhealth.comCustomer service (dropship)800.926.3161Holiday shipping/manufacturer shutdown onsumer olesale Aquisition Cost (WAC) price EA and State Facility comSupply Chain Excellence AwardBrand – DSA ManagerConsumer – Product Category ManagerGenerics – AdvisorEmergency purchase ordersGMB-EPOdesk@cardinalhealth.com or BuyerManufacturer Reference ManualDianne PfahlCountry of OriginGMB-GOV Sales Origin Conf@cardinalhealth.comQRA Drug Supply Chain Security Actdrugtracing@cardinalhealth.comQRA – Private nalhealth.comCustomer Service – Home Healthcare Drop800.530.2696Customer Service – Leader Private Label800.200.6313Dropship billingGMB-DUB-DS-CRM@cardinalhealth.comPurchase OrdersG-DUB-Brand PurchasingG-DUB-Consumer PurchasingG-DUB-Generic PurchasingREV 01/2017Manufacturer reference manual 5

Section 3Getting set up with Cardinal HealthPrior to engaging in business with the Pharmaceutical Segment of Cardinal Health, Cardinal Health requires that the manufacturerand Cardinal Health enter into a services agreement. For more information on establishing a relationship with Cardinal Health,contact ce a services agreement is in place, manufacturers will need to follow the new manufacturer set up process as guided by theCardinal Health Manufacturer Relations Team. Documents required by Cardinal Health to initiate new manufacturer set-up include: Certificate of Insurance, stating Cardinal Health andSubsidiaries as additional insured New Manufacturer Setup Sheet New Manufacturer Checklist (Attachment A) Manufacturer EDI Information Sheet Rebate Management System (RMS) Letter DSCSA Trading Partner Status/Advanced Trading Partner (ATP)acknowledgement (Attachment B) Wholesale Purchase Agreement/Wholesale DropshipAgreement, Generic Wholesale Service Agreement,Cardinal Health Supplier Agreement Diversity Affidavit Quality Agreement W9/W8 Manufacturer Portal Agreement (Attachment C) DEA Controlled Substance or list chemical registration number Copy of state licenses for the following states:-- Colorado-- Florida-- Illinois-- Missouri-- New Jersey-- North Carolina-- Oregon-- West Virginia Current list price for all products HDA product information sheet Safety Data Sheets (SDS) Package insert sheet Guaranteed Sales Letter (Consumer Health only)In the event of a conflict between the requirements of this Manufacturer Reference Manual and the terms of an agreement betweenCardinal Health and a manufacturer, the terms of the agreement prevail unless otherwise agreed in writing by Cardinal Health.New item set up processWhen launching a new item, please ensure you submit the following five documents to Cardinal Health Sourcing Manageror Category Manager in order to have the item set up in our system. HDA/NWDA Standard Product Information Form(Most current version) Package Insert Copy of all sides of Package Label SPS Information Pricing SheetCardinal Health must have all five documents before the item can be setup in our system. Failure to provide all of the aboveinformation will delay getting your new item ordered.Please see Attachment D for Consumer Health documents.REV 01/2017Manufacturer reference manual 6

Section 4Filling Cardinal Health purchase ordersOrders and shipments must be made in accordance with written agreements in place betweenCardinal Health and manufacturer.Standard purchase order transmissionsCardinal Health transmits purchase orders (PO) to the manufacturer using three methods: Electronic Data Interchange (EDI 850) - EDI POs are collected approximately every two minutes throughoutthe Cardinal Health work day. EDI services then recognizes and transmits to the manufacturers every 30 minuteson the half-hour. This process begins at 5:30 a.m. EST and ends at 10:30 p.m. EST. Fax - Fax POs are generated and sent via fax using the Cardinal Health automated fax system (FAX401) ormanually faxed. The FAX401 system transmits to the manufacturer every 2 minutes. AS2/Cyclone - AS2 is a point-to-point file transfer protocol (ftp) that is used to encrypt and transfer data filesvia the Internet. Cardinal Health is currently using Axway AS2 (formerly known, and also still sometimes referredto, as Cyclone) to trade data with both customers and manufacturers. This managed file transfer system movesEDI (x12-formatted) data as well as other types of data. For manufacturers already up on EDI, once they have theapplicable software on their side, they can contact vendoredi@cardinal.com to test and implement.Narcotic purchase order transmissionsNarcotic POs require special processing based on government regulations. Each manually transmitted narcotic POcan contain no more than 10 items and must be accompanied by a DEA blank number. Cardinal Health generally sendsthe PO and the accompanying DEA blanks (222) to the manufacturer via overnight delivery. However, processing ofthe EDI transmission cannot occur until the receipt of the corresponding DEA blank. All blanks expire in 60 days.Cardinal Health is now enabled with the DEA-approved Controlled Substance Ordering System (CSOS) through Axway/Cyclone AS2. This enables direct EDI 850 ordering of narcotics, and provides the Electronic 222 (e222) forms. This methodrequires that our manufacturers also be enabled with the appropriate technology and DEA Digital Certificate to receive,process and report to the DEA. This provides several advantages, including electronic signing and transmission forms,rather than physical overnight delivery and also eliminates the ten-line restriction that is in place for manual orders.Purchase order managementPurchase orders are expected to ship complete and consistently within the agreed upon lead time. An expecteddelivery date based on this lead time is generated for each purchase order transmitted by Cardinal Health. If for somereason a purchase order or purchase order line will not arrive within the normal lead time or will be partially shipped,Cardinal Health must be notified in advance. Please refer to the section on Product Availability reporting for informationon how and where to communicate this information to Cardinal Health.REV 01/2017Manufacturer reference manual 7