Standard Supply Chain Services. Customer Handbook Lubrizol LifeSciences Europe

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1 Standard Supply Chain Services Customer Handbook Lubrizol LifeSciences Europe 1

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3 Introduction We thank you for your interest in Lubrizol and its products. At Lubrizol, we are dedicated to making it easy for you to do business with us. This handbook, which details our standard Supply Chain service offerings, has been developed to ensure efficient and effective communication of the services we offer to you. Other specific services might be available depending on the manufacturing sites and the nature of our products. There are typically extra fees associated with non-standard requests, which often require additional supply chain resources. Should you need further information, please contact the sales manager or the customer experience representative (CER) responsible for your account. This handbook defines supply chain services for Lubrizol LifeSciences Polymers business in Europe. These services do not apply to Lubrizol LifeSciences Formulation, Development and Contract Manufacturing businesses. We look forward to working with you to meet the specific needs of your business. This information is also available on our internet website:

4 Contents Order Management & Processing Services / How Do I Place an Order?... 2 Customer Experience Center....2 Documentation....3 Ordering Lead Times....4 Lead Times....4 Changing Orders....5 Pricing & Payment Terms....5 Transportation & Shipping Information... 6 Locations & Loading Hours....6 Lubrizol s Transport Booking....7 Customer s Transport Booking....8 Pickup Instructions and Documents....9 Regulations Allowances & Demurrage Loading of Packed Goods Packaging Services Package Types Tamper Evidence Labelling Quality Controls & Procedures Upon Arrival at Your Premises Service After Shipment & Complaint Handling Product Returns Sampling / How Do I Order a Sample? Technical Service Support Business Continuity Management Systems Lubrizol LifeSciences Application

5 Order Management & Processing Services How Do I Place an Order? Customer Experience Center Orders can be placed by: Calling the Customer Experience Center located in Brussels, Belgium Tel : +32 (0) This is a secure site that requires user set up and password access. Online access can be requested directly through or contact your sales manager. This site has been created to complement our traditional contact with the Customer Experience Center. An Order Receipt and/or an Order Acknowledgement along with the Terms and Conditions are provided within two business days of receipt of order. Contacting the customer experience representative in charge of your account. Connecting directly on our internet website: 2

6 ORDER MANAGEMENT & PROCESSING SERVICES Documentation On as well as placing orders, you can obtain sales order documentation, and product information online 24 hours a day, seven days a week. Order receipt/order Acknowledgment Commercial Invoice Packing List Shipping documents (Delivery Notes) Certificate of Analysis (CoA) Multilingual Safety Data Sheet (SDS) Product Data Sheet (PDS) Additional documents are available upon request: International Consignment Note Dangerous Goods Declaration Export Customs Documents Some of our warehouses are bonded sites thus, with VAT suspension. Therefore, we are able to issue your export customs documents without the necessity of a forwarder. For national and intra E.U. exchanges, we may have to issue accompanying documents (AAD: Administrative Accompanying Document/documents established using EMCS (Excise Movement and Control System) e-ad: electronic administrative document/paper SAP: simplified AAD), relative to Combined Nomenclature Code of Goods. In this case, the customer would be responsible for handling the document at destination or having it cleared by his customs office. Should this clearance be missing, we would have to invoice the customs costs related to the sale, if any. 3

7 Ordering Lead Times Lead Times Lubrizol recommends using the following lead times for your planning purposes. The standard production lead times mentioned below (from order receipt to product availability) for orders received before 12.00am (GMT + 1) in the European Customer Experience Center. Our standard lead times are calculated in weeks and apply according to the forecasts you have previously shared with us. The following lead times reflect the average time necessary to manufacture and prepare customer orders for shipment. Lead times do not include transit time. Stocking Type Standard Lead Times Medical Pharma Some products can be manufactured and made available at outsourced locations. Our subcontracting plants are managed under our Quality Management System (QMS) Specific cases: Make-to-stock products may be available in shorter lead times. In case of volumes greater than 100 MT, please contact your customer experience representative to obtain the corresponding lead time. Products manufactured outside the European Union can require a minimum lead time of 10 to 12 weeks. New product: an additional lead time of 20 business days minimum may be necessary. Products not or under forecasted: up to 90 days depending on raw material availability. Made to Stock (MTS) 1 1 Made on Order (MOO) 6 8 Made to Order (MTO) 6 8 4

8 ORDER MANAGEMENT & PROCESSING SERVICES Changing Orders Changes made to orders within two business days of the scheduled ship date can create operational issues and should be avoided. Order changes could result in a need to reschedule and may cause delays or may incur additional fees. Please contact the customer experience representative in charge of your orders to check the feasibility of your request. Packed Order Amendment / Cancellation Less than 2 working days prior to the confirmed loading date 250 Euros Late Collection (Non-collection of an order on the confirmation date) Packed goods, full truck load 250 Euros / working day Packed goods, less than truck load 100 Euros / working day Pricing & Payment Terms Standard terms of sale are net thirty (30) days from date of invoice. Selling price shall be the price mentioned in the Order Acknowledgement. In addition to our FCA prices (Free Carrier, Incoterms 2010), the following charges may be added when applicable: Other costs related to Incoterms 2010 (Freight rate, insurance ) Any local taxes including VAT (value added tax) Charges are converted in the invoicing currency at the rate in force at the time of invoicing. Miscellaneous Services Demurrage at your premises 45 Euros / hour (free time allowance for package: 2 hours) 5

9 Transportation & Shipping Information Locations & Loading Hours You will find hereafter our plants loading addresses and loading hours: Lubrizol s Plants Addresses / Shipping Loading Hours Business Loading Address Loading Hours Pharma Katoen Natie, Polymer Processing Oudedijk 1, Blokveld 10 Haven 1998 B-9130 Kallo Belgium 8 a.m. 3 p.m. Medical Lubrizol Advanced Materials Europe BVBA Nijverheidsstraat , Westerlo-Oevel Belgium 7:30 a.m. 3:30 p.m. ES&S LOGISTICS Van Doornelaan WESTERLO Belgium 8:30 a.m. 4:30 p.m. ATTENTION: Trucks have to arrive at least 30 minutes before closing time. 6

10 TRANSPORTATION & SHIPPING INFORMATION Lubrizol s Transport Booking In order to offer you a comprehensive service, we can organize deliveries to your plant. For this purpose, we have selected reliable hauliers with whom we have established long-term agreements. By choosing Lubrizol s transport, one single contact will handle your orders and deliveries as well as the follow-up of your shipments. Demurrage costs will remain at our charge if loadings exceed the free-time allowance. We will ensure that the applicable transport regulations are respected and that the selected companies comply with our mutual hygiene, security, health and environmental requirements. transport local or international. You shall inform Lubrizol the same day of any such claim. In the absence of such notification, weight or volume of product shall be deemed to be the weight or volume mentioned on the International Consignment Note. In any other case, you shall give notification of any product s non compliance to its specifications, to Lubrizol by registered letter within seven days from goods receipt. Organizing transport helps us to optimize our production and loading schedules by controlling the trucks arrival times, which contributes to the continuous improvement of our quality of service. The incoterm used defines the transfer of risk for the product loss or damage occuring during transport. In such an event, you need to make reservations on the International Consignment Note relating to any damage, loss, weight discrepancy upon product delivery for obvious defects. For other defects, reservations should be made no later than three or seven days, depending on the 7

11 The transit times negotiated with our hauliers comply with regulations in force. For multimodal, rail, maritime transport and consolidation of packed goods, lead times can vary and delivery dates are given for your information only. The delivery times you communicate to us will be conveyed to our hauliers who will endeavor to respect them as much as possible but without commitment from our part. Customer s Transport Booking In case of FCA Incoterms 2010 sales from Lubrizol sites, our staff will load your carrier s truck on the confirmed date. All risks and obligations related to the transport are supported by you. Our transport rates are based on the distance and the means of transport used. They also include loading and unloading allowances. Road Transport: The free unloading allowance is two hours for packed goods (for shipments above 3MT). Beyond these allotted times, demurrage will be charged based on the relevant documentation (International Consignment Note) signed both by you and the driver. Demurrage at your premises (above legal allowances) Based on haulier s invoice 8

12 TRANSPORTATION & SHIPPING INFORMATION Pickup Instructions & Documents Please ensure that the drivers follow the below instructions when loading at one of our plants and have the proper documents available: In order to be granted access to our loading sites, drivers must have our loading reference and the following IPE (individual protective equipment): safety helmet, safety glasses and safety shoes, covering clothes (long sleeves and pants), gloves and compulsory safety harness for bulk loadings. Safety procedures: drivers must either have safety procedures signed between Lubrizol and the haulier or the streamlined version which will be handed over to them upon arrival. In case your driver does not comply with these rules, he/she will be evicted and denied future access to our site. Identification (ID): drivers should be able to provide their ID or passport in order to be identified. Truck driving licence. Driver s training certificate for the transport of dangerous goods. Instructions in writing ADR Valid certificates of approval for the vehicles. Cleanliness certificate (see paragraph Regulations). Drivers must attend loadings as they are carried out under their responsibility. For safety reasons, drivers should be able to understand instructions provided by our personnel on site in the local language or in English. If applicable, it is the driver s responsibility to indicate to our staff the customs office where the export documents will be cleared. You must ensure that the documents handed to the drivers will be cleared, either in an office of exit of the E.U. or in an inland office recognized by the NCTS (New Computerized Transit System). Should this clearance be missing, we will be compelled to invoice you with the customs tax and duties related to this sale, if any. Please consider any other specific instructions (slot time, specific equipment ) mentioned on the Order Acknowledgment sent by the customer experience representative. 9

13 Regulations The hauliers you charter must comply with any local, national and international laws related to transportation and to quality requirements for LUBRIZOL products. The driver will be required to present a cleanliness certificate certified by APLICA (Association Professionnelle des Laveurs Intérieurs de Citernes Agréés, agreement dated 22/03/1993) or EFTCO (agreement dated 24/06/1999 completed with the European Cleaning Document created in 2004) dated of maximum five working days for tank trucks and of one month for containers. Beyond this validity, you will need to provide us with a non-loading certificate. A visual control will be done to check that the tank is clean, dry and odor free. Otherwise the truck will be refused and will be sent to the nearest certified cleaning station. Penalties for late collection might apply in this case. (see paragraph Allowances & Demurrage) Some of our products are classified hazardous according to current regulations. Hazardous classes are mainly 3 (UN 1993 and 3256), 8 (UN 1760 and 3267) and 9 (UN 3257 and 3082). All trucks loading these goods have to comply with legal norms for transportation of chemical additives according to ADR/IMDG/RID/IATA* regulations. In reference to the article of the ADR and IMDG regulations, the filling level of a tank truck shall be less than 20% or greater than 80% (not exceeding 95%), unless the tank is divided into sections of not more than 7,500 liters capacity or equipped with surge plates. Lubrizol applies the same rules for non-hazardous products. When unloading bulk deliveries, the truck driver is responsible for opening and closing of manholes, valves, lids, and any other truck equipment and connecting hoses to his truck. *ADR IATA IMDG RID European Regulation for road transportation of Dangerous Goods Regulation for air transportation of Dangerous Goods International Maritime Dangerous Goods Code International Regulation for rail transportation of Dangerous Goods 10

14 TRANSPORTATION & SHIPPING INFORMATION Allowances & Demurrage We apply the free-time allowance regulations in force for package loading. It is necessary that drivers collect orders on the loading date confirmed by us, within the opening hours mentioned in paragraph Locations & Loading Hours or at the agreed slot time. Delays may block a manufacturing tank or loading bay and disrupt our schedules. Trucks arriving early or late might be loaded according to staff and equipment availability. Demurrage for waiting time will not be accepted. 11

15 Loading of Packed Goods: As shipper, we are responsible for the loading, stowing and securing of packaged cargo. The stowing is done by the driver under the supervision of a Lubrizol employee who will guarantee that the operation is made in the respect of the norm EN Trailers must be fitted with the following equipment: Anti-slip material (pad or roll) Lashing straps complying with EN norm, with a tensing effect higher than 350 dan Edge protectors Cross beams/lashing beams Lashing points complying with the EN norm 2 wheel-chocks (to be put in place by the driver) Should one of the above described equipment be missing, the loading could be refused. For safety reasons, we cannot accept to load the below transport equipment: Refrigerated trailer Low bed trailer Jumbo or swan neck trailer Trailers with width lower than 2.40 meters Trailer with a metallic floor or equipped with rolling conveyor system Flatbed truck 12

16 Packaging Services Package Types: Medical Package Types: Pharmaceutical Type Capacity (Kg) Dimension (cm) 1 BOX = Primary packaging is plastic bag and secondary packaging is cardboard box Bags 25 Bags in carton box Eurobox Octabins Other packages might be available, please contact your CER for further details. The tare may vary but this has no impact on the net weight, as filling is performed based on the net weight of product per package. In order to guarantee the quality of our products and an optimal packaging, we cannot accept to fill customer s packaging. Gross Weight 21.8 Kg ( gr. Max tolerance) Net Weight 20.0 Kg (+ or 100 gr. max tolerance) Volume 55 L Box size: 515 x 343 x 521 mm. Taped on top and bottom No handles on the side Product packaging consists of a fibreboard box and an appropriate inner liner to maintain the integrity of the product. The inner liner used for packaging excipients is a polyethylene bag and serves as a moisture barrier. LDPE liners are Phthalates free, not reactive, additive, or adsorptive material. 13

17 Tamper Evidence All packaging for chemicals materials include a tamperevident seal. The liner is sealed with a tamper-evident cable tie. The box is sealed in such a way that tampering would be evident. The box is UN-certified and provides adequate protection of the product against deterioration during transportation and storage. Only new boxes and liners are used to package product. Containers are not reused. Labelling Workplace Label: Product designation Batch number Net weight Hazard communication as per CLP (Classification, Labelling and Packaging) regulation as needed Pallets are heat treated and marked in accordance with the International Plant Protection Convention (IPPC) global standard ISPM 15. Delivery and Distribution The box used in packaging excipients is designed to provide protection throughout distribution and delivery. Boxes of product are palletized and stretched wrapped prior to shipment. This provides added dimensional stability and protection. 14

18 PACKAGING SERVICES Shipping label: Lubrizol and/or customer product description Customer s purchase order number Batch number Net weight Delivery note Shipping and delivery addresses Emergency contact number Transport regulatory information, as needed Destination Label: Lubrizol and/or customer product description Batch number Net weight Delivery note Hazard communication labelling in destination country s language when needed (pictograms) as per CLP (Classification, Labelling and Packaging) regulation as needed 15

19 Quality Controls & Procedures We hereunder summarize specific arrangements that have been made to meet our commitments to our customers and to deliver products in accordance with their specifications. Product specifications are identical irrespective of the production site. Prior To Any Shipment: We control compliance of raw materials specifications received from suppliers and periodical audits are carried out. We check and maintain our technical equipment in a proper state of repair. Regulated controls and preventive. maintenance programs are scheduled mainly in the matter of metrology. We establish, follow and check a quality control plan for. manufacturing each component and each finished product. This plan includes: analytic tests to be carried out, methods of analysis to be used, required specifications, as well as all necessary controls to secure. data traceability. These data are the basis for issuing Certificate of Analysis, part of the shipping documents.. Lab results are archived for 10 years and allow development of statistical analyses. Cleanliness of empty packages are checked before loading. Retain samples are collected and saved to make further. analysis possible in case of disagreement. Depending on their origins, samples are retained as follows: raw materials (three months), intermediates (one year), finished products before shipping (two years). 16

20 QUALITY CONTROLS & PROCEDURES Upon Arrival at Your Premises: The above controls and procedures, the selection of specialized haulers, our compliance with HSSE and transportation regulations and supply of Material Safety Data Sheets, guarantee that our products are delivered as per your specifications if applicable. By ensuring through audit controls that the above mentioned measures are respected, you may establish your own unloading policy and decide under your own responsibility whether to carry out quality and quantity controls upon products arrival. 17

21 Service After Shipment & Complaint Handling With each shipment, Lubrizol strives for complete customer satisfaction. We value input from our customers to help drive continuous improvement. Should you have a concern with an order after it has shipped, our staff will work directly with you to address your concern. Lubrizol is fully committed to deliver the best possible customer experience to you. You can also visit and simply select Contact Us to request either an SDS or ISO certificate. Additional service after shipment requests, such as product specifications, technical data sheets and customer questionnaires should be directed to your sales manager or customer experience representative. To report a complaint about a product or service, please initially contact your customer experience representative or sales account manager. They will be able to assist and obtain information from you to help mitigate the immediate issue. Important details to provide are the product name, batch number, delivery number, your purchase order and the nature of the complaint. Your customer experience representative is responsible to coordinate all activities including mitigation, resolution and the implementation of corrective and preventive actions and communication with you. For Safety Data Sheet (SDS) or Product Data Sheet (PDS) requests, please visit selecting the Quick Links 18

22 SERVICE AFTER SHIPMENT & COMPLAINT HANDLING Product Returns Lubrizol s customers may request the return of Lubrizol products to a Lubrizol facility. All product returns must be authorized by Lubrizol prior to returning any material to our facilities. The standard policy is to accept product returns under the following conditions: Original packaging with seals intact. Partial packages will not be accepted. The date of the request of the return must be within 90 days of receipt of the goods. Original Lubrizol production batch number(s) must be provided. Return of exclusive products will be evaluated on a case-by-case basis. In general, materials produced exclusively for a particular customer may not be returned on the basis of convenience. If the material has a recommended retest date, that date must not have expired, or be within two months of expiring (six months of expiring for pharmaceutical excipients). Should you intend to request the return of packed goods to one of our facility, please contact your customer experience representative with the following information: Reason for the return Number of drums Batch number for each drum Product storage conditions (specify if drums were stored outside or placed in heating room etc.) Whether or not original seals are intact Condition of the drums Lubrizol invoice number This information will enable our different departments to determine if the return can be accepted. If the return is approved, we will issue a credit note after reception of the products in our plant. Our administrative and restocking charges are taken into account in the terms of the return. In some cases, a sample may be needed in order to analyze and validate the final decision. 19

23 Sampling / How Do I Order a Sample? Lubrizol is pleased to offer samples of standard products on a free of charge basis. Sample requests may be submitted in two ways: 1. By contacting your customer experience representative or sales manager, or 2. By visiting the Lubrizol web site clicking the LifeSciences link, selecting Sample Request, then selecting either Request Medical TPU Sample or Request Pharmaceutical Sample. By clicking on either, you will be able to access a Sample Request Form. If a sample requires expediting, please provide your preferred small package service provider and corresponding account number so we may assist you as quickly as possible. Technical Service Support The Lubrizol LifeSciences business is well positioned to assist you with any technical support you may require. Our skilled technical service scientists located in North America can assist you with use of our products including subjects ranging from formulation tips to manufacturing process guidance. To request technical service support, visit the Lubrizol web site click the LifeSciences link, select Contact Us, then Technical Solutions. For any other questions, please contact your account manager, customer service representative, or 20

24 Business Continuity Lubrizol has developed a business continuity plan in order to react swiftly and efficiently in the case of unforeseen events and to allow the return to business as commercially practicable. These measures include crisis scenarios permitting us to rapidly form a committee who will be capable to manage the situation. The global supply chain team together with the commercial division will endeavor to maintain continuous supply. 21 Business Continuity is Essential as Industry Requirements Change and Markets Grow and Mature Globalization of supply Varied and broad product performance requirements International expansion of Original Equipment Manufacturers (OEM s) Strategic connection with brand, reputation and value We Achieve This Through: Supply chain analysis from raw material procurement to finished product delivery Enterprise-wide processes for managing supply interruption risk Business continuity plans for sustainability / continuous improvement Holistic and personalized approach tailored to customer needs Our goal is to anticipate prevent and contain disruptive events across the value chain in order to maintain industry leading supply reliability.

25 Management Systems The Lubrizol Corporation subscribes to the guiding principles of Responsible Care. Globally, all manufacturing and research and development centers are encouraged to manage their HSES programs under a management system, utilizing third-party oversight and certification where appropriate. Internal assessments are expected to be conducted periodically utilizing internal and external resources. Our quality management system as well as our ISO 9001 and and OHSAS certifications contribute to the continuous improvement of the services and products we offer. A Sustainable Approach to Business Align our sustainability efforts with our customers goals for mutual success Includes providing products and services to help them meet their sustainability needs Set goals and action plans through 2020 to minimize environmental footprint Apply guiding principles of American Chemistry Council s Responsible Care initiative as foundation on a global basis Adhere to REACH, the European community s regulation on chemicals and their safe use Use lifecycle assessments to help generate innovations in product design, development and manufacturing processes Committed to actively strengthen the Responsible Care initiative worldwide as demonstrated through the signing of the Responsible Care Global Charter Committed to achieve and maintain Responsible Care Management System (RCMS) certification through third party audits at Lubrizol U.S. facilities 22

26 Lubrizol LifeSciences is your medical device + pharmaceutical polymer solutions partner. We are polymer experts. Lubrizol LifeSciences produces a wide variety of medical-grade thermoplastic polyurethane (TPU). We are one of the world s largest manufacturers of medical grade TPU and our polymers have been used throughout the healthcare industry for over 30 years. We also produce pharmaceutical polyacrylic acid excipients (e.g. Carbopol, Noveon AA-1, Pemulen products). We are the world s largest manufacturer of carbomers and have been manufacturing pharmaceutical excipients for over 35 years. Medical-grade polymers and polymeric excipients Custom polymer synthesis Advanced polymeric drug delivery platforms Expertise across a wide range of biomedical and biopharmaceutical polymers 23

27 Application The services in this document and the related sales of products are subject to the terms and conditions of any written supply agreement or Lubrizol s standard terms and conditions of sale (as the case may be); collectively called Standard Terms. In the event of a conflict between the Standard Terms and this document, the Standard Terms will prevail. Lubrizol will not be responsible if events beyond the reasonable control of Lubrizol prevent or impair Lubrizol s ability to provide the services or products indicated. Being Essential When your company and ours combine energies, great things can happen. You bring ideas, challenges and opportunities. We bring powerful market expertise, unmatched testing capabilities, integrated global supply and an independent approach to help you differentiate and succeed. 24

28 Lubrizol Advanced Materials Europe BVBA Chaussée de Wavre Brussels Belgium Phone: Fax: The Lubrizol Corporation. All rights reserved. June 2017

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