Manual for the daily cooperation related to the supply of

Manual for the daily cooperation related to the supply of Medicinal products to Amgros and the hospital pharmacies in Denmark Version 4.0 Page 1

Contents Instruction in relation to the framework agreement... 3 Purchase of medicinal products... 3 Supply Chain Contact Persons... 3 Wholesaler/distributor... 3 Definitions... 3 Update of Manual... 3 Scope of Manual... 4 Orders... 4 Back orders... 4 Compensation for extra costs and mitigation of damages... 5 Replacement purchase... 5 Shelf life... 5 Complaints about quality... 5 Complaints about price and quantity... 6 Stockpile... 6 Estimates... 6 Information sharing... 6 Supplier website at the Supplier s website (Mine firmasider)... 6 ESPD and ESPD documentation... 7 39 in the Danish Medicines Act (Company authorisation)... 7 Import control... 7 Assignment of framework agreement... 7 New product, other product under a framework agreement or change of product no.... 8 Bar Codes... 8 Registration of products in Medicinpriser.dk... 8 Questions and comments... 8 Appendix 1: Supply Chain Contact Person with the Supplier... 9 Appendix 2: Definitions in relation to back orders... 10 Objective... 10 Basis of the definitions... 10 Definitions... 10 Appendix 3: Template to communication of closing days... 13 Appendix 4: Changelog... 14 Version 4.0 Page 2

Instruction in relation to the framework agreement Amgros has developed this manual for the daily cooperation between suppliers, distributors/wholesalers, hospital pharmacies, and Amgros. In case of doubt or discrepancies between the signed framework agreement and this manual, it is the provisions stipulated in the framework agreement that prevail. Purchase of medicinal products In accordance with the EU-regulations for public procurement, Amgros carries out tendering processes and signs agreements on an ongoing basis for the supply of the anticipated demand for medicinal products at all public hospitals in Denmark. Amgros uses electronic processing of orders and additional documentation. Amgros processes electronically every order for medicinal products from the hospital pharmacies to the suppliers. Order confirmations and invoices from suppliers are sent via Amgros to the hospital pharmacies. The physical order is delivered directly by the supplier or wholesaler/distributor to the hospital pharmacies. For further information, please see the paragraph about the requirements to import and acceptance control of medicinal products for the hospital pharmacies. Supply Chain Contact Persons It is important to exchange names of supply chain contact persons to ensure that both Amgros and the suppliers know whom to contact. Thus, prior to start of the purchase period, Amgros will ask the suppliers to submit the completed form in Appendix 1. Wholesaler/distributor It is important to inform Amgros about the wholesaler/distributor used, if any. This information must be listed together with contact persons in Appendix 1. If the supplier enters into an agreement with a wholesaler(s)/distributor(s) during the contract term, the supplier must inform Amgros by sending a new Appendix 1 to kundeservice@amgros.dk. Definitions In the day-to-day work, Amgros is using the Definitions of back orders specified in Appendix 2. Update of Manual This manual will be updated whenever Amgros becomes aware of new topics to be described or one of the paragraphs needs to be updated. Changelog is available in Appendix 3. The latest version of this manual is available on Amgros supplier & tendering portal (Amgros leverandør og udbudsportal). Version 4.0 Page 3

Scope of Manual The manual applies to every contracted product delivered via Amgros I/S to the hospital pharmacies. Orders The framework agreement stipulates a maximum delivery time of three working days from the supplier receives the order until the product is delivered to the hospital pharmacy. By working days is meant Monday to Friday except for Danish public holidays, 5 June, 24 December, and 31 December. Normally, there are daily deliveries to the hospital pharmacies, thus orders received before 12 p.m. will be delivered the following day. The individual hospital pharmacy places orders with Amgros on a regular basis. Subsequently, Amgros places orders with the supplier. Orders will be placed electronically or by fax. Upon receipt, the supplier confirms the order, electronically if possible. To confirm the order, the supplier informs Amgros about the product, quantity and expected time of delivery. Based upon this information, Amgros confirms the order to the hospital pharmacy. When the product is dispatched, the supplier is to send an electronic shipment advice to inform Amgros that dispatch has taken place. If a hospital pharmacy wishes to cancel/change an order, the hospital pharmacy will contact the supplier directly by phone or fax. The order management system in Amgros is immediately updated. If a hospital pharmacy urgently requires a product, the hospital pharmacy can place an order by phone with the supplier or wholesaler(s)/distributor(s). The product should be included in the next delivery to the hospital pharmacy. Back orders Amgros is obliged to ensure a continuous supply of medicinal products to all patients at the Danish hospitals. Thus, a good working relationship and close dialogue between the suppliers and Amgros is important. If the time of delivery of three working days is exceeded, the supplier is under contractual obligation to inform Amgros immediately in writing about the reason for the delay and the expected date of delivery. The supplier must also inform Amgros in writing whenever the supplier foresee delivery problems of a product. Given accurate and early information about expected delivery, at first Amgros in cooperation with the supplier will allocate the deliveries to the hospital pharmacies as required. Amgros will subsequently try to acquire substitute products from another supplier. In case the supplier expects not to be able to supply for a period of time, Amgros welcomes suggestions from the supplier to substitute products, which Amgros will take into considerations in relation to the compensation purchase. In this way the supplier will be actively involved in reducing as much as possible the extra costs involved in the compensation purchase. Version 4.0 Page 4

Once the situation of back order is resolved, and the supplier is able to resume delivery, the supplier must immediately inform Amgros in writing when the supplier will be able to fully comply with the agreement s delivery obligations. Together with the information about delivery time, the supplier should state exact dates for products in stock (i.e. Appendix 2). If a supplier is only able to state a period of time for expected recommencement of supply, Amgros will use the delivery time defined in Appendix 2. Compensation for extra costs and mitigation of damages If a supplier fails to deliver an ordered product on time or cannot replace a defective product within the delivery time, the product is considered to be on back order. The back order situation continues until the supplier has the product in stock again (please see Appendix 2 Products in stock). For the sake of practicalities and the planning of the purchasing, the back order situation is considered resolved at the earliest two working days after the supplier has adequately demonstrated to Amgros the ability to supply and stockpiling (please see Appendix 2 Back order situation). During the entire back order situation, Amgros is entitled to make compensation purchase, and the supplier is obliged to cover the extra costs associated with the compensation purchase throughout the back order situation. The liability to compensate will apply whether or not the medicinal products purchased are used within the back order situation. Under the framework agreement, the hospital pharmacies and Amgros must observe the usual rules in relation to the duty to mitigate damages, however, in consideration of the provisions stated in the signed agreement. Amgros decides to make compensation purchase in consideration of patient safety and resources for which reason product switch should be avoided, if possible. The consideration for stable supply is also essential for Amgros decision on the compensation purchase. Replacement purchase Mainly managed under the framework agreement. Settlement of replacement purchase is normally carried out on a quarterly basis. In case of late information from the hospital pharmacies about replacement purchase, Amgros reserves the right to settle the extra costs as soon as Amgros is notified. Shelf life The minimum remaining shelf life of medicinal products must be 12 months at delivery. As regards medicinal products intended for resale to Greenland, the minimum remaining shelf life must be 18 months at delivery. As regards medicinal products for which the product summary states a shorter shelf life than 12 or 18 months respectively, at delivery the actual remaining shelf life should be longer than half the shelf life stated in the product summary for the medicinal product in question. Complaints about quality Complaints about quality and delivery are settled directly between hospital pharmacy and supplier, e.g. complaints about shelf life, damaged goods, incorrect deliveries, etc. Version 4.0 Page 5

Complaints about price and quantity In case of incorrect delivery e.g. delivered quantity compared to ordered quantity, the hospital pharmacy or Amgros will contact the supplier and request remediation. Kundeservice@amgros.dk should be included as c.c. in all mail correspondence about delivery of incorrect quantity between the supplier and the hospital pharmacy. If discussions between hospital pharmacy and supplier are carried out by phone, the supplier must subsequently inform Amgros about the outcome of the discussions. If Amgros detects an incorrect price when checking the invoice, Amgros will contact the supplier. Stockpile On grounds of consistency of supply, on effective date of the framework agreement the supplier must have stock adequate to at least 3 months of the expected consumption. Hereafter and throughout the entire contract term, the supplier must demonstrate a properly maintained stockpile of every medicinal product, unless otherwise stipulated in the framework agreement, e.g. stockpile should be 1/6 of the consumption throughout the term. The quantity of a properly maintained stockpile should be assessed based on the provided estimates, the actual purchasing under the framework agreement and the market development, so that the supplier will always be able to supply all orders received within the delivery time of three days. Throughout the entire contract term, the supplier must on be able to provide documentation of compliance with the demand of properly maintained stockpile Amgros request. Furthermore, Amgros is entitled to conduct audits at the supplier s site to verify that the demands to stockpiling and stock are met. If the supplier stores his medicinal products at a wholesaler(s)/distributor(s), the supplier must make sure that Amgros has access to conduct audits at the wholesaler/distributor s site. Amgros will announce the time of audit in advance. Estimates Amgros informs the supplier about revised estimates, when Amgros receives this information from the hospital pharmacies. Amgros supplies actual sales figures to Dansk Lægemiddel Information A/S (Danish Pharmaceutical Information) on a daily basis. Information sharing To ensure smooth and easy communication between the parties, Amgros shares information on a regular basis via the Amgros tendering & supplier site and other electronic media. Amgros informs frequently the hospital pharmacies about the back order situation. Supplier website at the Supplier s website (Mine firmasider) As of June 1, 2015 Amgros communicates with the suppliers as far as possible by a dedicated company website, Mine firmasider. The communication includes documents in relation to tenders such as letters to tenderer with information regarding the tender evaluation, framework agreements, estimates and prolongation of framework agreement as well as previous bids (submitted after June 1, 2015) together with an overview of current back orders and other functions. The company site can be accessed only by users employed or otherwise associat- Version 4.0 Page 6

ed with the company (password and email login). Amgros wants the most up-to-date information as possible concerning any back order. It is therefore possible for you to submit an email from this site directly to Amgros Customer Service with updated information about your back orders. Furthermore, the supplier must upload valid ESPD, ESPD documentation, and also company authorisations ( 39 authorisation) to Mine firmasider. ESPD and ESPD documentation As an element in the tender process, Amgros requires that every tenderer submit an ESPD (European Single Procurement Document). In connection with Amgros tenders for pharmaceuticals, the ESPD is used as a self-declaration from every tenderer. The self-declaration serves as a preliminary proof that the tenderer is not in one of the situations stated in the Tender Law in which the tenderer shall be excluded. Amgros can only award a contract or framework agreement to tenderers who can document that the information provided in the ESPD on the exclusion grounds is correct. Further information about the ESPD and ESPD documentation is available in Encl. 2 to the general tender conditions Vejledning til det fælles europæiske udbudsdokument (ESPD) and dokumentation for udelukkelsesgrunde (Guidance to the European Single Procurement Document and documentation of exclusion grounds), which is a part of the tender material. 39 in the Danish Medicines Act (Company authorisation) Amgros is authorised by the Danish Medicines Agency. To make sure that Amgros observes the GDP rules it is a requirement that Amgros receives the 39 authorisation from every supplier at effective date of purchase period. Future updated versions of the supplier s 39 authorisation are to be uploaded to the supplier s site at Mine firmasider. As for foreign suppliers, an equivalent authorisation (company authorisation) from a qualified EU authority should be submitted to Amgros at effective date of purchase period. In case a Danish representative/wholesaler is employed, a written cooperation agreement between the parties is also required. Import control Prior to delivery to hospital pharmacies, the supplier must make sure that all medicinal products undergo import control under existing laws, cf. section 4.2 in the signed framework agreement. In this way, the hospital pharmacy shall only perform goods receipt of the orders. In case the supplier is unable to render this control in Denmark, a wholesaler or other Danish companies specialising in this field can render this service. It is the responsibility of the supplier that this is done prior to delivery of the product to the hospital pharmacy. Assignment of framework agreement The supplier is not permitted to assign to third party his rights and obligations without Amgros written consent. The process for assignment of framework agreement is available on Amgros tender & supplier site. Version 4.0 Page 7

New product, other product under a framework agreement or change of product no. The process in connection with including a new product or another product under a framework agreement is available on Amgros tender and suppliers site. Amgros must receive early information about change of product number of a contracted product, e.g. in connection with changes to packaging material, by e-mail to kundeservice@amgros.dk. Any change has to be approved by Amgros before it is implemented. Bar Codes The hospital pharmacies and Amgros are currently developing the use of bar codes. The current requirements to bar codes of the individual product types, requested types of bar codes and the placement of these on the medicinal products and packing material are stated in an enclosure to the framework agreement. It is the responsibility of the supplier to enter and to maintain information about bar codes used on the primary packaging on Amgros tendering & supplier site. Registration of products in Medicinpriser.dk Medicinal products must be listed in www.medicinpriser.dk throughout the contract term. The latest date of registration of a price at www.medicinpriser.dk is stipulated in the framework agreement. Normally, it is two rate periods prior to effective date of purchase period. The Danish Medicines Agency must receive information from the supplier no later than 14 days before the rate period, in which the product is required to be included. For further information, please see: http://laegemiddelstyrelsen.dk/da/tilskud/priser/anmeldelse-af-priser-og-sortiment/tidsfrister Example: Effective date of purchase period is 1 April 2016 = registration of information at www.medicinpriser.dk no later than 29 February 2016. Questions and comments If you have questions or comments to this manual for the cooperation with Amgros and the hospital pharmacies, please contact kundeservice@amgros.dk. Version 4.0 Page 8

Appendix 1: Supply Chain Contact Person with the Supplier Supplier: Daily Contact Person Name Mail Phone Contact Persons with Amgros Name Mail Phone Daily Contact Person Lisbeth Petersen kundeservice@amgros.dk +45 8871 3012 Daily Contact Person Pernille Schwartz kundeservice@amgros.dk +45 8871 3014 Daily Contact Person Dorte Kjæmpe kundeservice@amgros.dk +45 8871 3018 Daily Contact Person Marlene Jensen kundeservice@amgros.dk +45 8871 3045 Supply Chain Lars Munck lmu@amgros.dk +45 8871 3042 Tenders udbud@amgros.dk Please send information to Amgros about new back orders or changes in relation to existing back orders by kundeservice@amgros.dk Present wholesaler(s)/distributor(s) Wholesaler/distributor: Name Mail Phone Daily Contact Person Wholesaler/distributor: Daily Contact Person Name Mail Phone Version 4.0 Page 9

Appendix 2: Definitions in relation to back orders Used in the communication between Amgros and hospital pharmacies, suppliers, and wholesalers/distributors. Objective Amgros has formulated the following definitions which are used in connection with back orders. The objective of the definitions is to establish a common language and understanding when Amgros, hospital pharmacies, suppliers, and wholesalers/distributors are communicating about back orders. Basis of the definitions The definitions are developed based on Amgros handling of back orders. Other parties of the supply chain might experience the individual situation of back order differently than Amgros dependent on their place in the supply chain and their stock, order and supply situation. The use of FA below refers to the Amgros standard framework agreement which forms the basis of drawing up framework agreements with the individual supplier. The standard framework agreement is available on Amgros suppliers portal. Definitions Normal delivery period = timely delivery In case of timely delivery, delivery shall take place no later than 3 working days after receipt of order by the supplier. By working days is meant Monday to Friday except for Danish public holidays, 5 June, 24 December and 31 December (FA clause 9). Back order = Lack of timely delivery It is a back order situation when delivery has not taken place within 3 working days after receipt of order by the supplier. In case of back order, the supplier is obliged to compensate Amgros and the hospital pharmacies additional costs if any. End of back order (FA clause 12.3) The back order situation is considered ended at the earliest 2 calendar days after the supplier has adequately demonstrated to Amgros his ability to supply and to stockpile. Example: If on a Monday a supplier informs Amgros that all back orders will be delivered on the following Wednesday, and that there are products in stock (please see below) also as of that Wednesday, the back order situation is considered resolved on the next Friday. Situation of back order (FA clause 12.3) The back order situation is the time span in which the supplier is unable to supply a product. The situation starts when the first difficulty in delivery has been demonstrated and runs until at least 2 calendar days after the date where all open orders have been delivered, and the supplier has products in stock ready for delivery. During the back order situation, delivery of specific orders can take place in case the supplier is in a position to deliver some of the quantity backordered. Version 4.0 Page 10

Products in stock A product is considered to be in stock at the supplier s site, when the product is physically in the distribution warehouse of the supplier and qualitatively has the status of released, thus it can be dispatched directly to a hospital pharmacy on receipt of order. Notification of delivery time In the event of back orders, the supplier must inform Amgros about when the supplier or the wholesaler(s)/distributor(s) will be able to resume normal delivery in practice. Notification of delivery time, more than one wholesaler/distributor If the supplier employs more than one wholesaler/distributor, Amgros should be informed to which distributor(s) the delivery time applies. Date of delivery Amgros must be informed about the exact date of when a product is expected to be in stock and ready for dispatch to the hospital pharmacies. Week of delivery If a supplier informs of the week in which a product is expected to be in stock, Amgros will based on this information assume that the product will be in stock with the usual distributor of the supplier s products on Monday morning of the following week. Month of delivery If a supplier informs of the month in which a product is expected to be in stock, Amgros will based on this information assume that the product will be in stock with the usual distributor of the supplier s products on the first working day of the following month. At the beginning of, in the middle of or at the end of are interpreted as follows: Informed by the supplier At the beginning In the middle At the end Expected receipt and release in the period As of 1st up to and including 10th As of 11th up to and including 20th As of 21st up to and including last day of the month Released products are expected to be supplied from stock with the usual distributor On 11th On 21st On 1st of the next month If one of the dates falls on a weekend/danish public holidays, the products are expected to be in stock the next working day. Version 4.0 Page 11

Quantity If a supplier does not inform Amgros about the expected quantity, the entire quantity backordered is expected to be covered by the next delivery. Until a supplier is again able to supply products from stock, the products are considered still to be backordered. Version 4.0 Page 12

Appendix 3: Template to communication of closing days It is a great help when the supplier informs Amgros about closing days in connection with bank holidays. The requested information is to be entered into the template below and submitted to kundeservice@amgros.dk in good time. Please note that no matter whether the supplier has informed Amgros about a closing period, the supplier is still under the obligation to deliver all orders within three (3) weekdays, even if a closing period lasts for more than three weekdays. Supplier/ product Time of last order Supplier X 12.05.2015 12:00 p.m. Supplier X, product A and B 12.05.2015 1:00 p.m. Delivery Delivery of later orders Remarks 13.05.2015 18.05.2015 Any emergency orders by phone: xx xx xx xx 13.05.2015 19.05.2015 Version 4.0 Page 13

Appendix 4: Changelog Version No. Changes in comparison with the previous version Version No. 1 New document Version No. 2 Version No. 3 Version No. 4 Clarification of the sections concerning Back orders and Compensation for extra costs and mitigation of damages Insertion of the paragraphs Supplier website at the Supplier s website (Mine Firmasider) and Import and acceptance control Insertion of the paragraph ESPD and ESPD documentation Version 4.0 Page 14